Elie A Akl

American University of Beirut, Beyrouth, Beyrouth, Lebanon

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Publications (284)1363.91 Total impact

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    ABSTRACT: Background: The World Health Organization (WHO) was tasked with developing health system guidelines for the implementation of rehabilitation services. Stakeholders' perceptions are an essential factor to take into account in the guideline development process. The aim of this study was to assess stakeholders' perceived feasibility and acceptability of eighteen rehabilitation services and the values they attach to ten rehabilitation outcomes. Methods: We disseminated an online self-administered questionnaire through a number of international and regional organizations from the different WHO regions. Eligible individuals included persons with disability, caregivers of persons with disability, health professionals, administrators and policy makers. The answer options consisted of a 9-point Likert scale. Results: Two hundred fifty three stakeholders participated. The majority of participants were health professional (64 %). In terms of outcomes, 'Increasing access' and 'Optimizing utilization' were the top service outcomes rated as critical (i.e., 7, 8 or 9 on the Likert scale) by >70 % of respondents. 'Fewer hospital admissions', 'Decreased burden of care' and 'Increasing longevity' were the services rated as least critical (57 %, 63 % and 58 % respectively). In terms of services, 'Community based rehabilitation' and 'Home based rehabilitation' were found to be both definitely feasible and acceptable (75 % and 74 % respectively). 'Integrated and decentralized rehabilitation services' was found to be less feasible than acceptable according to stakeholders (61 % and 71 % respectively). As for 'Task shifting', most stakeholders did not appear to find task shifting as either definitely feasible or definitely acceptable (63 % and 64 % respectively). Conclusion: The majority of stakeholder's perceived 'Increasing access' and 'Optimizing utilization' as most critical amongst rehabilitation outcomes. The feasibility of the 'Integrated and decentralized rehabilitation services' was perceived to be less than their acceptability. The majority of stakeholders found 'Task shifting' as neither feasible nor acceptable.
    Full-text · Article · Dec 2016 · Health and Quality of Life Outcomes
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    ABSTRACT: Background: The Grading of Recommendations Assessment, Development and Evaluation (GRADE) is widely used and reliable and accurate for assessing the certainty in the body of health evidence. The GRADE working group has provided detailed guidance for assessing the certainty in the body of evidence in systematic reviews and health technology assessments (HTA), and how to grade the strength of health recommendations. However, there is limited advice regarding how to maximize transparency of these judgments, in particular through explanatory footnotes or explanations in Summary of Findings tables and Evidence Profiles (GRADE evidence tables). Methods: We conducted this study to define the essential attributes of useful explanations and to develop specific guidance for explanations associated with GRADE evidence tables. We utilized a sample of explanations according to their complexity, type of judgment involved, and appropriateness from a database of published GRADE evidence tables in Cochrane reviews and World Health Organization (WHO) guidelines. We used an iterative process and group consensus to determine the attributes and develop guidance. Results: Explanations in GRADE evidence tables should be concise, informative, relevant, easy to understand, and accurate. We provide general and domain-specific guidance to assist authors with achieving these desirable attributes in their explanations associated with GRADE evidence tables. Conclusions: Adhering to the general and GRADE domain-specific guidance should improve the quality of explanations associated with GRADE evidence tables, assist authors of systematic reviews, health technology assessment (HTA) reports, or guidelines with information that they can use in other parts of their evidence synthesis. This guidance will also support editorial evaluation of evidence syntheses using GRADE and provide a minimum quality standard of judgments across tables.
    No preview · Article · Jan 2016 · Journal of clinical epidemiology
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    ABSTRACT: Background: The current format of Summary-of-Findings (SoF) tables for presenting effect estimates and associated quality of evidence improve understanding and assist users finding key information in systematic reviews. Users of SoF Tables have demanded alternative formats to express findings from systematic reviews. Methods/design: We conducted a randomized controlled trial among systematic review users to compare the relative merits of a new format with the current formats of SoF tables regarding understanding, accessibility of information, satisfaction, and preference. Our primary goal was to show that the new format is not inferior to the current format. Results: Of 390 potentially eligible subjects, 290 were randomized. Of 7 items testing understanding, 3 showed similar results, 2 showed small differences favoring the new format, and two (understanding risk difference and quality of the evidence associated with a treatment effect) showed large differences favoring the new format (63% (95% CI 55-71) and 62% (95% CI 52-71) more correct answers, respectively). Respondents rated information in the alternative format as more accessible overall and preferred the new format over the current format. Conclusions: While providing at least similar levels of understanding for some items and increased understanding for others users prefer the new format of SoF tables.
    No preview · Article · Jan 2016 · Journal of clinical epidemiology
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    ABSTRACT: We update recommendations on 12 topics that were in the 9th edition of these guidelines, and address 3 new topics.
    No preview · Article · Jan 2016 · Chest
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    ABSTRACT: An increasing number of organizations worldwide are using new and improved standards for developing trustworthy clinical guidelines. One of such approaches, developed by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) working group, offers systematic and transparent guidance in moving from evidence to recommendations. The GRADE strategy concentrates on four factors: The balance between benefits and harms, the certainty of the evidence, values and preferences and resource considerations. However, it also considers issues around feasibility, equity and acceptability of recommendations. GRADE distinguishes two types of recommendations: strong and weak. Strong recommendations reflect a clear preference for one alternative and should apply to all or almost all patients, obviating the need for a careful review of the evidence with each patient. Weak recommendations are appropriate when there is a close balance between desirable and undesirable consequences of alternative management strategies, uncertainty regarding the effects of the alternatives, uncertainty or variability in patients’ values and preferences or questionable cost-effectiveness. Weak recommendations usually require accessing the underlying evidence and a shared decision-making approach. Clinicians using GRADE recommendations should understand the meaning of the strength of the recommendation, be able to critically appraise the recommendation, and apply trustworthy recommendations according to their strength.
    No preview · Article · Jan 2016 · Journal of clinical epidemiology
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    ABSTRACT: Bariatric surgery is the most effective therapeutic option to reduce weight in morbidly obese individuals, but it results in a number of mineral and vitamin deficiencies. Clinical Practice Guidelines (CPGs) attempt to balance those benefits and harms to provide guidance to physicians and patients.
    No preview · Article · Jan 2016 · Metabolism: clinical and experimental
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    ABSTRACT: Objectives We conducted a systematic survey of the methodological literature to identify recommended approaches for how and what randomised clinical trial (RCT) authors should report on missing participant data and, on the basis of these approaches, to propose guidance for RCT authors. Methods We defined missing participant data (MPD) as missing outcome data for trial participants. We considered both categorical and continuous outcome data. We searched MEDLINE and the Cochrane Methodology Register for articles in which authors proposed approaches to reporting MPD from RCTs. We selected eligible articles independently and in duplicate and extracted data in duplicate. Using an iterative process of discussion and revisions, we used the findings to develop guidance. Results Of 10 501 unique citations identified, 13 articles reporting on 10 approaches proved eligible. The identified approaches recommend reporting the following aspects (from most to least frequently recommended): number of participants with MPD (n=10), reasons for MPD (n=7), methods used to handle MPD in the analysis (n=4), flow of participants (n=3), pattern of missingness (eg, whether at random) (n=3), differences in rates of MPD between trial arms (n=2), differences between participants with and without MPD (n=2), results of any sensitivity analyses (n=2), implication of MPD on interpreting the results (n=2) and methods used to prevent missing data (n=1). We propose a guide with nine items related to reporting the number, reasons, patterns, analytical methods and interpretation of MPD. Conclusions Most identified approaches invite trial authors to report the extent of MPD and the underlying reasons. Fewer approaches focus on reporting missingness patterns, methods for handling MPD and implications of MPD on results. Our proposed guidance could help RCT authors to better report, and readers to better identify participants with missing data.
    Full-text · Article · Dec 2015 · BMJ Open
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    ABSTRACT: Background and objectives: Lowering the dialysate temperature may improve outcomes for patients undergoing chronic hemodialysis. We reviewed the reported benefits and harms of lower temperature dialysis. Design, setting, participants, & measurements: We searched the Cochrane Central Register, OVID MEDLINE, EMBASE, and Pubmed until April 15, 2015. We reviewed the reference lists of relevant reviews, registered trials, and relevant conference proceedings. We included all randomized, controlled trials that evaluated the effect of reduced temperature dialysis versus standard temperature dialysis in adult patients receiving chronic hemodialysis. We followed the Grading of Recommendations Assessment, Development and Evaluation approach to assess confidence in the estimates of effect (i.e., the quality of evidence). We conducted meta-analyses using random effects models. Results: Twenty-six trials were included, consisting of a total of 484 patients. Compared with standard temperature dialysis, reduced temperature dialysis significantly reduced the rate of intradialytic hypotension by 70% (95% confidence interval, 49% to 89%) and significantly increased intradialytic mean arterial pressure by 12 mmHg (95% confidence interval, 8 to 16 mmHg). Symptoms of discomfort occurred 2.95 (95% confidence interval, 0.88 to 9.82) times more often with reduced temperature compared with standard temperature dialysis. The effect on dialysis adequacy was not significantly different, with a Kt/V mean difference of -0.05 (95% confidence interval, -0.09 to 0.01). Small sample sizes, loss to follow-up, and a lack of appropriate blinding in some trials reduced confidence in the estimates of effect. None of the trials reported long-term outcomes. Conclusions: In patients receiving chronic hemodialysis, reduced temperature dialysis may reduce the rate of intradialytic hypotension and increase intradialytic mean arterial pressure. High-quality, large, multicenter, randomized trials are needed to determine whether reduced temperature dialysis affects patient mortality and major adverse cardiovascular events.
    No preview · Article · Dec 2015 · Clinical Journal of the American Society of Nephrology
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    ABSTRACT: Background: Occupational sharps injuries are associated with transmission of bloodborne viruses to healthcare workers, including hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). Similarly reuse of syringes in healthcare settings might transmit these infections between patients. The objective of this study was to systematically review the evidence about the effects of the use by health care workers of two types of safety engineered injection devices, when delivering intramuscular, subcutaneous, or intradermal injectable medications: sharps injury protection syringes and reuse prevention syringes. Methods: We included both randomized and non-randomized studies comparing safety syringes to syringes without safety features. Outcomes of interest included needlestick injuries, and HIV, HBV and HCV infections amongst HCWs (for sharps injury prevention syringes) and patients (for reuse prevention syringes). When possible, we conducted meta-analyses using a random-effects model. We tested results for heterogeneity across studies using the I statistic. We assessed the quality of evidence by outcome using the GRADE methodology. Results: We included nine eligible studies: six assessed devices that qualify as sharps injury prevention devices, and three assessed devices that qualify as both injury prevention devices and reuse prevention devices. Eight studies were observational while one was randomized. All studies assessed a single outcome: needle stick injuries among healthcare workers. For sharp injury prevention syringes, the meta-analysis of five studies resulted in a pooled relative risk of 0.54 [0.41, 0.71] for the effect on needlestick injuries per healthcare worker. The associated quality of evidence was rated as moderate. For reuse prevention syringes, data from one study provided a relative risk of 0.40 [0.27, 0.59] for the effect on needlestick injuries per healthcare worker. The associated quality of evidence was rated as moderate. We identified no studies reporting on the effect on the reuse of syringes. Conclusions: We identified moderate quality evidence that syringes with sharps injury prevention feature reduce the incidence of needlestick injuries per healthcare worker. We identified no studies reporting data for the remaining outcomes of interest for HCWs. Similarly we identified no studies reporting on the effect of syringes with a reuse prevention feature on the reuse of syringes or on the other outcomes of interest for patients.
    Preview · Article · Dec 2015 · BMC Nursing
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    ABSTRACT: Pregnant women with prior venous thromboembolism (VTE) are at risk of recurrence. Prophylaxis with low molecular weight heparin (LWMH) reduces that risk but is inconvenient, costly, and may be associated with increased risks of obstetrical bleeding. The views of pregnant women, crucial when making prophylaxis recommendations, are currently unknown.
    No preview · Article · Dec 2015 · Thrombosis Research
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    ABSTRACT: Acute ischemic mitral regurgitation (MR) is seen in patients with myocardial infarction and is associated with increased morbidity and mortality. The optimal treatment strategy of this condition however, is not well established. The aim of this manuscript is to conduct a systematic review of the medical literature to assess the relative benefits and harms of mitral valve surgery with medical therapy versus medical management alone for patients with acute ischemic MR of at least moderate severity. We performed a literature search in MEDLINE, Embase.com, and Cochrane Central Register of Controlled Trials. We restricted the search to randomized clinical trials comparing surgical to medical management of acute ischemic MR. Exclusion criteria included non-randomized trials, trials enrolling patients with non-ischemic MR, and trials excluding acute ischemic MR. The primary outcomes were short-term and long term mortality. Two reviewers (WA, WA) screened titles and abstracts of identified citations independently and in duplicate using calibration exercises and standardized screening forms. The search strategy identified 887 citations (137 were duplicates and removed). Of the 750 titles, 709 were excluded (519 were non-relevant and 190 were review articles and case reports). Of the 41 remaining abstracts, 37 were retrospective cohorts and four excluded acute MR, leaving no eligible study for analysis. An ongoing study that is being conducted at Southern Illinois University entitled by “Medical Versus Surgical Management of Patients With Moderate Mitral Regurgitation Following Percutaneous Coronary Intervention for Myocardial Infarction: A Pilot Prospective Randomized Trial” was identified; however, it was just withdrawn after failing to enroll patients during 4 years. This is an empty systematic review that identified no published randomized trials for the management of acute MR complicating acute MI. The only ongoing randomized study that was identified was just withdrawn after failing to enroll patients. There is an urgent need for conducing proper randomized trials in order to guide informed decision making in the treatment of acute ischemic MR. PROSPERO registration number CRD42013005843
    Full-text · Article · Dec 2015 · BMC Research Notes
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    ABSTRACT: Purpose: We conducted a systematic review and meta-analysis to address benefits and harms of using elastic compression stockings after lower-extremity deep vein thrombosis. Methods: We searched 7 electronic databases through January 15(th) 2015, including randomized controlled trials (RCTs)/quasi-randomized trials reporting on elastic compression stocking efficacy on post-thrombotic syndrome incidence, recurrent venous thromboembolism, mortality and acute pain after deep vein thrombosis. Two reviewers independently screened records, extracted data, assessed risk of bias, and assessed confidence in effect estimates using GRADE methodology. We applied random-effects meta-analysis models. Results: We included 5 RCTs (n=1418) reporting on post-thrombotic syndrome. The hazard ratio (HR) for post-thrombotic syndrome with elastic compression stockings was 0.69 (95% CI 0.47-1.02). We have very low confidence in this estimate due to heterogeneity and inclusion of unblinded studies at high risk of bias. Excluding high risk of bias studies, a single large RCT at low risk of bias provided moderate quality evidence of no effect on post-thrombotic syndrome (HR 1.00, 95% CI 0.81-1.24). Moderate quality evidence including all 5 studies suggests no effect of elastic compression stockings on recurrent venous thromboembolism (RR 0.88, 95% CI 0.63-1.24) or mortality (RR 1.00, 95% CI 0.73-1.37, 5 studies). Moderate quality evidence from one large RCT does not suggest effect on acute pain after deep vein thrombosis. Conclusions: The highest quality evidence available suggests no effect of elastic compression stockings on post-thrombotic syndrome or pain relief, from a single large RCT. However, results for preventing post-thrombotic syndrome differ substantially across studies, and future guideline updates should reflect uncertainty about treatment effects. Elastic compression stockings are unlikely to prevent death or recurrent venous thromboembolism.
    No preview · Article · Dec 2015 · The American journal of medicine
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    Full-text · Article · Nov 2015 · Annals of Oncology
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    ABSTRACT: Background: There is evidence that physicians' prescription behavior is negatively affected by the extent of their interactions with pharmaceutical companies. In order to develop and implement policies and interventions for better management of interactions, we need to understand physicians' perspectives on this issue. Surveys addressing physicians' interactions with pharmaceutical companies need to use validated tools to ensure the validity of their findings. Objective: To assess the validity of tools used in surveys of physicians about the extent and nature of their interactions with pharmaceutical companies, and about their knowledge, beliefs and attitudes towards such interactions; and to identify those tools that have been formally validated. Methods: We developed a search strategy with the assistance of a medical librarian. We electronically searched MEDLINE and EMBASE databases in September 2015. Teams of two reviewers conducted data selection and data abstraction. They identified eligible studies in one table and then abstracted the relevant data from the studies with validated tools in another table. Tables were piloted and standardized. Results: We identified one validated questionnaire out of the 11 assessing the nature and extent of the interaction, and three validated questionnaires out of the 47 assessing knowledge, beliefs and attitudes of physicians toward the interaction. None of these validated questionnaires were used in more than one survey. Conclusion: The available supporting evidence of the issue of physicians' interaction with pharmaceutical company is of low quality. There is a need for research to develop and validate tools to survey physicians about their interactions with pharmaceutical companies.
    Full-text · Article · Nov 2015 · BMC Research Notes
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    ABSTRACT: Guidelines and recommendations developed and/or endorsed by the American College of Rheumatology (ACR) are intended to provide guidance for particular patterns of practice and not to dictate the care of a particular patient. The ACR considers adherence to the recommendations within this guideline to be voluntary, with the ultimate determination regarding their application to be made by the physician in light of each patient's individual circumstances. Guidelines and recommendations are intended to promote beneficial or desirable outcomes but cannot guarantee any specific outcome. Guidelines and recommendations developed and endorsed by the ACR are subject to periodic revision as warranted by the evolution of medical knowledge, technology, and practice. ACR recommendations are not intended to dictate payment or insurance decisions. These recommendations cannot adequately convey all uncertainties and nuances of patient care. The ACR is an independent, professional, medical and scientific society that does not guarantee, warrant, or endorse any commercial product or service.
    Full-text · Article · Nov 2015
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    ABSTRACT: Background/objective: Prior studies regarding whether single centre trial estimates are larger than multi-centre are equivocal. We examined the extent to which single centre trials yield systematically larger effects than multi-centre trials. Methods/design: We searched the 119 core clinical journals and the Cochrane Database of Systematic Reviews for meta-analyses (MAs) of RCTs published during 2012. In this meta-epidemiological study, for binary variables we computed the pooled ratio of ORs (ROR), and for continuous outcomes mean difference in SMDs, and conducted weighted random-effects meta-regression and random-effects meta-analyses modeling. Our primary analyses were restricted to MAs that included at least 5 RCTs and in which at least 25% of the studies used each of SC and MC designs. Results: We identified 81 MAs for the OR and 43 for the SMD outcome measures. Based on our analytic plan, our primary analysis (core) is based on 25 MAs/241 RCTs (binary outcome) and 18 MAs/173 RCTs (continuous outcome). Based on the core analysis, we found no difference in magnitude of effect between SC and MC for binary outcomes (RORs: 1.02, 95% CI 0.83-1.24, I(2) 20.2%). Effect sizes were systematically larger for SC than MC for the continuous outcome measure (mean difference in SMDs: -0.13, 95% CI -0.21- -0.05, I(2) 0 %). Conclusions: Our results do not support prior findings of larger effects in SC than MC trials addressing binary outcomes, but show a very similar small increase in effect in SC than MC trials addressing continuous outcomes. Authors of systematic reviews would be wise to include all trials irrespective of SC versus MC design and address SC versus MC status as a possible explanation of heterogeneity (and consider sensitivity analyses).
    No preview · Article · Nov 2015 · Journal of clinical epidemiology
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    ABSTRACT: Background: Expressing treatment effects in relative terms yields larger numbers than expressions in absolute terms, affecting the judgement of the clinicians and patients regarding the treatment options. It is uncertain how authors of systematic reviews (SRs) absolute effect estimates are reported in). We therefore undertook a systematic survey to identify and describe the reporting and methods for calculating absolute effect estimates in SRs. Methods: Two reviewers independently screened title, abstract and full text, and extracted data from a sample of Cochrane and non-Cochrane SRs. We used regression analyses to examine the association between study characteristics and the reporting of absolute estimates for the most patient-important outcome. Results: We included 202 SR (98 Cochrane and 104 non-Cochrane), the majority of which (92.1%) included standard meta-analyses including relative estimates of effect. Of the 202 SRs, 73 (36.1%) reported absolute effect estimates for the most patient-important outcome. SRs with statistically significant effects were more likely to report absolute estimates (odds ratio: 2.26, 95%-CI: 1.08 to 4.74). The most commonly reported absolute estimates were: for each intervention, risk of adverse outcomes expressed as a percentage (41.1%); number needed to treat (26.0%); and risk for each intervention expressed as natural units or natural frequencies (24.7%). In 12.3% of the SRs that reported absolute effect estimates for both benefit and harm outcomes, harm outcomes were reported exclusively as absolute estimates. Exclusively reporting of beneficial outcomes as absolute estimates occurred in 6.8% of the SRs. Conclusions: Most SRs do not report absolute effects. Those that do often report them inadequately, thus requiring users of SRs to generate their own estimates of absolute effects. For any apparently effective or harmful intervention, SR authors should report both absolute and relative estimates to optimise the interpretation of their findings.
    Full-text · Article · Nov 2015 · Journal of clinical epidemiology
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    ABSTRACT: Background: Meta-analyses of continuous outcomes typically provide enough information for decision-makers to evaluate the extent to which chance can explain apparent differences between interventions. The interpretation of the magnitude of these differences - from trivial to large - can, however, be challenging. We investigated clinicians' understanding and perceptions of usefulness of 6 statistical formats for presenting continuous outcomes from meta-analyses (standardized mean difference, minimal important difference units, mean difference in natural units, ratio of means, relative risk and risk difference). Methods: We invited 610 staff and trainees in internal medicine and family medicine programs in 8 countries to participate. Paperbased, self-administered questionnaires presented summary estimates of hypothetical interventions versus placebo for chronic pain. The estimates showed either a small or a large effect for each of the 6 statistical formats for presenting continuous outcomes. Questions addressed participants' understanding of the magnitude of treatment effects and their perception of the usefulness of the presentation format. We randomly assigned participants 1 of 4 versions of the questionnaire, each with a different effect size (large or small) and presentation order for the 6 formats (1 to 6, or 6 to 1). Results: Overall, 531 (87.0%) of the clinicians responded. Respondents best understood risk difference, followed by relative risk and ratio of means. Similarly, they perceived the dichotomous presentation of continuous outcomes (relative risk and risk difference) to be most useful. Presenting results as a standardized mean difference, the longest standing and most widely used approach, was poorly understood and perceived as least useful. Interpretation: None of the presentation formats were well understood or perceived as extremely useful. Clinicians best understood the dichotomous presentations of continuous outcomes and perceived them to be the most useful. Further initiatives to help clinicians better grasp the magnitude of the treatment effect are needed.
    Full-text · Article · Oct 2015 · Canadian Medical Association Journal
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    ABSTRACT: Randomized clinical trials that enroll patients in critical or emergency care (acute care) setting are challenging because of narrow time windows for recruitment and the inability of many patients to provide informed consent. To assess the extent that recruitment challenges lead to randomized clinical trial discontinuation, we compared the discontinuation of acute care and nonacute care randomized clinical trials. Retrospective cohort of 894 randomized clinical trials approved by six institutional review boards in Switzerland, Germany, and Canada between 2000 and 2003. Randomized clinical trials involving patients in an acute or nonacute care setting. We recorded trial characteristics, self-reported trial discontinuation, and self-reported reasons for discontinuation from protocols, corresponding publications, institutional review board files, and a survey of investigators. Of 894 randomized clinical trials, 64 (7%) were acute care randomized clinical trials (29 critical care and 35 emergency care). Compared with the 830 nonacute care randomized clinical trials, acute care randomized clinical trials were more frequently discontinued (28 of 64, 44% vs 221 of 830, 27%; p = 0.004). Slow recruitment was the most frequent reason for discontinuation, both in acute care (13 of 64, 20%) and in nonacute care randomized clinical trials (7 of 64, 11%). Logistic regression analyses suggested the acute care setting as an independent risk factor for randomized clinical trial discontinuation specifically as a result of slow recruitment (odds ratio, 4.00; 95% CI, 1.72-9.31) after adjusting for other established risk factors, including nonindustry sponsorship and small sample size. Acute care randomized clinical trials are more vulnerable to premature discontinuation than nonacute care randomized clinical trials and have an approximately four-fold higher risk of discontinuation due to slow recruitment. These results highlight the need for strategies to reliably prevent and resolve slow patient recruitment in randomized clinical trials conducted in the critical and emergency care setting.
    Full-text · Article · Oct 2015 · Critical care medicine
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    ABSTRACT: Background: Reports of randomized clinical trials (RCTs) do not always specify whether participants belonging to certain categories (e.g. those who withdraw consent, non-compliers) were followed-up for the outcome(s) of interest or not (i.e. missing participant data (MPD)). Systematic reviewers may, therefore, have to make assumptions on whether data from these participants is missing. Objectives: To describe characteristics, reporting and handling of categories of participants that could be potentially counted as having MPD in RCTs included in Cochrane and non-Cochrane systematic reviews (SRs). Methods: We selected a random sample of 100 Cochrane and non-Cochrane SRs published in 2012. Eligible SRs reported a group-level meta-analysis of a patient-important dichotomous efficacy outcome, with a statistically significant effect estimate. Ten reviewers, working in pairs, independently extracted data from the RCTs included in eligible meta-analyses. We focused on 10 categories that could be potentially counted as MPD: 'participants deemed ineligible after randomization', 'did not receive any treatment', 'withdrew consent', 'outcome not assessable', 'explained and unexplained lost to follow-up', 'dead', 'experienced adverse events', 'non-compliant', 'discontinued prematurely', and 'cross-over'. We specifically assessed: 1) the number of participants in those categories; 2) whether trialists explicitly reported on the follow-up status of those participants; and 3) how trialists handled those participants in their analysis. Results: We included a total of 672 RCTs included in 100 eligible Cochrane and non-Cochrane SRs. We are in the process of data abstraction. We will present the findings of the study at the Colloquium. Conclusions: Results will inform a better understanding of trial reporting on the follow-up, and handling of categories with potentially missing outcome data, an issue of importance for systematic reviewers and for standards of trial reporting.
    No preview · Conference Paper · Oct 2015

Publication Stats

9k Citations
1,363.91 Total Impact Points

Institutions

  • 2010-2016
    • American University of Beirut
      • Department of Internal Medicine
      Beyrouth, Beyrouth, Lebanon
    • Medical College of Wisconsin
      Milwaukee, Wisconsin, United States
  • 2005-2016
    • McMaster University
      • Department of Clinical Epidemiology and Biostatistics
      Hamilton, Ontario, Canada
  • 2004-2013
    • University at Buffalo, The State University of New York
      • • Department of Medicine
      • • Department of Social and Preventive Medicine
      Buffalo, New York, United States
  • 2012
    • Universitätsklinikum Freiburg
      • Institute of Medical Biometry and Statistics
      Freiburg an der Elbe, Lower Saxony, Germany
    • CUNY Graduate Center
      New York, New York, United States
  • 2005-2010
    • State University of New York
      New York City, New York, United States
  • 2009
    • Erie County Medical Center
      New York City, New York, United States
  • 2007
    • Istituto Regina Elena - Istituti Fisioterapici Ospitalieri
      Roma, Latium, Italy