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Journal of Clinical Epidemiology

Jamilla A Hussain, Martin Bland, Dean Langan, Miriam J Johnson, David C Currow, Ian R White
OBJECTIVES: Assess (i) the quality of reporting and handling missing data in palliative care trials against current guidance, (ii) whether there are differences in the reporting of criteria specified by the CONSORT 2010 statement compared to those not specified, (iii) the association of the reporting of missing data with journal impact factor and CONSORT endorsement status. STUDY DESIGN AND SETTING: Systematic review of palliative care randomised controlled trials...
May 19, 2017: Journal of Clinical Epidemiology
Gordon H Guyatt, Shanil Ebrahim, Pablo Alonso-Coello, Bradley C Johnston, Alexander G Mathioudakis, Matthias Briel, Reem A Mustafa, Xin Sun, Stephen D Walter, Diane Heels-Ansdell, Ignacio Neumann, Lara A Kahale, Alfonso Iorio, Joerg Meerpohl, Holger J Schünemann, Elie A Akl
OBJECTIVE: To provide GRADE guidance for assessing risk of bias across an entire body of evidence consequent on missing data for systematic reviews of both binary and continuous outcomes. STUDY DESIGN: Systematic survey of published methodological research, iterative discussions, testing in systematic reviews, and feedback from the GRADE Working Group. RESULTS: Approaches begin with a primary meta-analysis using a complete case analysis followed by sensitivity meta-analyses imputing, in each study, data for those with missing data, and then pooling across studies...
May 18, 2017: Journal of Clinical Epidemiology
Evan Mayo-Wilson, Nicole Fusco, Tianjing Li, Hwanhee Hong, Joe Canner, Kay Dickersin
OBJECTIVE: To identify variations in outcomes and results across public and non-public reports of randomized clinical trials (RCTs). STUDY DESIGN AND SETTING: Eligible RCTs examined gabapentin for neuropathic pain and quetiapine for bipolar depression, reported in public (e.g., journal articles) and non-public sources (e.g., clinical study reports) available by 2015. We recorded pre-specified outcome domains. We considered outcomes "defined" if they included the domain, measure, metric, method of aggregation, and time-point...
May 18, 2017: Journal of Clinical Epidemiology
Tibor Schuster, Wilfrid Kouokam Lowe, Robert W Platt
No abstract text is available yet for this article.
May 18, 2017: Journal of Clinical Epidemiology
David S Riley, Melissa S Barber, Gunver S Kienle, Jeffry Aronson, Tido von Schoen-Angerer, Peter Tugwell, Helmut Kiene, Mark Helfand, Douglas G Altman, Harold Sox, Paul G Werthmann, David Moher, Richard A Rison, Larissa Shamseer, Christian A Koch, Gordon H Sun, Patrick Hanaway, Cleveland Clinic, Nancy L Sudak, Marietta Kaszkin-Bettag, Joel J Gagnier
Well-written and transparent case reports (1) reveal early signals of potential benefits, harms, and information on the use of resources; (2) provide information for clinical research and clinical practice guidelines (CPGs), and (3) inform medical education. High-quality case reports are more likely when authors follow reporting guidelines. During 2011-2012 a group of clinicians, researchers, and journal editors developed recommendations for the accurate reporting of information in case reports that resulted in the CARE (CAse REport) Statement and Checklist...
May 18, 2017: Journal of Clinical Epidemiology
Monica Hultcrantz, David Rind, Elie A Akl, Shaun Treweek, Reem A Mustafa, Alfonso Iorio, Brian S Alper, Joerg J Meerpohl, M Hassan Murad, Mohammed T Ansari, Srinivasa Vittal Katikireddi, Pernilla Östlund, Sofia Tranæus, Robin Christensen, Gerald Gartlehner, Jan Brozek, Ariel Izcovich, Holger Schünemann, Gordon Guyatt
OBJECTIVE: To clarify the GRADE (grading of recommendations assessment, development and evaluation) definition of certainty of evidence and suggest possible approaches to rating certainty of the evidence for systematic reviews, health technology assessments and guidelines. STUDY DESIGN AND SETTING: This work was carried out by a project group within the GRADE Working Group, through brainstorming and iterative refinement of ideas, using input from workshops, presentations, and discussions at GRADE Working Group meetings to produce this document, which constitutes official GRADE guidance...
May 18, 2017: Journal of Clinical Epidemiology
Hector Pardo-Hernandez, Pablo Alonso-Coello
No abstract text is available yet for this article.
May 18, 2017: Journal of Clinical Epidemiology
Elaine Irving, Rutger van den Bor, Paco Welsing, Veronica Walsh, Rafael Alfonso-Cristancho, Catherine Harvey, Nadia Garman, Diederick E Grobbee
Pragmatic trials offer the opportunity to obtain real-life data on the relative effectiveness and safety of a treatment before or after market authorisation. This is the penultimate paper in a series of eight, describing the impact of design choices on the practical implementation of pragmatic trials. This paper focuses on the practical challenges of collecting and reporting safety data and of monitoring trial conduct while maintaining routine clinical care practice. Current ICH guidance recommends that, all serious adverse events (SAEs) and all drug-related events must be reported in an interventional trial...
May 11, 2017: Journal of Clinical Epidemiology
Sally D Worsley, Katrien Oude Rengerink, Elaine Irving, Stephane Lejeune, Koen Mol, Sue Collier, Rolf H H Groenwold, Catherine Enters-Weijnen, Matthias Egger, Thomas Rhodes
No abstract text is available yet for this article.
May 11, 2017: Journal of Clinical Epidemiology
Paco Welsing, Katrien Oude Rengerink, Sue Collier, Laurent Eckert, Maarten van Smeden, Antonio Ciaglia, Gaelle Nachbaur, Sven Trelle, Aliki Taylor, Matthias Egger, Iris Goetz
Results from pragmatic trials should reflect the comparative treatment effects encountered in patients in real-life clinical practice to guide treatment decisions. Therefore pragmatic trials should focus on outcomes that are relevant to patients, clinical practice, and treatment choices. This 6(th) paper in the series (see box) discusses different types of outcomes and their suitability for pragmatic trials, design choices for measuring these outcomes and their implications and challenges. Measuring outcomes in pragmatic trials should not interfere with real-world clinical practice to ensure generalizability of trial results and routinely collected outcomes should be prioritized...
May 11, 2017: Journal of Clinical Epidemiology
Shona Kalkman, Ghislaine Jmw van Thiel, Mira Gp Zuidgeest, Iris Goetz, Boris M Pfeiffer, Diederick E Grobbee, Johannes Jm van Delden
The Innovative Medicines Initiative's (IMI) GetReal consortium aims to develop strategies to incorporate real world evidence earlier into the drug life cycle to better inform health care decision-makers on the comparative risks and benefits of new drugs. Pragmatic trials are currently explored as a means to generate such evidence in routine care settings. The traditional informed consent model for randomized clinical trials has been argued to pose substantial hurdles to the practicability of pragmatic trials: it would lead to recruitment difficulties, reduced generalizability of the results and selection bias...
May 11, 2017: Journal of Clinical Epidemiology
Katrien Oude Rengerink, Shona Kalkman, Susan Collier, Antonio Ciaglia, Sally D Worsley, Alison Lightbourne, Laurent Eckert, Rolf H H Groenwold, Diederick E Grobbee, Elaine A Irving
This paper addresses challenges of identifying, enrolling and retaining participants in a in a trial conducted within a routine care setting. All patients that are potential candidates for the treatments in routine clinical practice should be considered eligible for a pragmatic trial. To ensure generalizability, the recruited sample should have a similar distribution of the treatment effect modifiers as the target population. In practice this can be best achieved by including - within the selected sites - all patients without further selection...
May 11, 2017: Journal of Clinical Epidemiology
Elie A Akl, Vivian Welch, Kevin Pottie, Javier Eslava-Schmalbach, Andrea Darzi, Ivan Sola, Srinivasa Vittal Katikireddi, Jasvinder Singh, M Hassan Murad, Joerg Meerpohl, Roger Stanev, Eddy Lang, Elizabeth Matovinovic, Beverley Shea, Thomas Agoritsas, Paul E Alexander, Alexandra Snellman, Romina Brignardello-Petersen, David Gloss, Lehana Thabane, Chunhu Shi, Airton T Stein, Ravi Sharaf, Matthias Briel, Gordon Guyatt, Holger Schünemann, Peter Tugwell
OBJECTIVE: to provide guidance for guideline developers on how to consider health equity at key stages of the guideline development process. STUDY DESIGN AND SETTING: literature review followed by group discussions and consensus building. RESULTS: The key stages at which guideline developers could consider equity include setting priorities, guideline group membership, identifying the target audience(s), generating the guideline questions, considering the importance of outcomes and interventions, deciding what evidence to include and searching for evidence, summarising the evidence and considering additional information, wording of recommendations, and evaluation and use...
May 9, 2017: Journal of Clinical Epidemiology
Isabel Oliveras, Josep-Maria Losilla, Jaume Vives
OBJECTIVES: In this paper, we compile and describe the main approaches proposed in the literature to include methodological quality or risk of bias into research synthesis. We also meta-review how the risk of bias of observational primary studies is being assessed and to what extent the results are incorporated in the conclusions of research synthesis. STUDY DESIGN AND SETTING: Electronic databases were searched for systematic reviews or meta-analyses related to health and clinical psychology...
May 9, 2017: Journal of Clinical Epidemiology
E Gargon, P R Williamson, B Young
OBJECTIVES: To explore core outcome set (COS) developers' experiences of their work in order to inform methodological guidance on COS development and identify areas for future methodological research. STUDY DESIGN AND SETTING: Semi-structured, audio-recorded interviews with a purposive sample of 32 COS developers. Analysis of transcribed interviews was informed by the constant comparative method and framework analysis. RESULTS: Developers found COS development to be challenging, particularly in relation to patient participation and accessing funding...
May 8, 2017: Journal of Clinical Epidemiology
Cornelis A van den Bogert, Patrick C Souverein, Cecile T M Brekelmans, Susan W J Janssen, Gerard H Koëter, Hubert G M Leufkens, Lex M Bouter
OBJECTIVE: To identify the reasons for discontinuation of clinical drug trials and to evaluate whether efficacy-related discontinuations were adequately planned in the trial protocol. STUDY DESIGN AND SETTING: All clinical drug trials in the Netherlands, reviewed by Institutional Review Boards (IRBs) in 2007, were followed until December 2015. Data were obtained through the database of the Dutch competent authority (CCMO) and a questionnaire to the principal investigators...
May 6, 2017: Journal of Clinical Epidemiology
Jean-Luc Faillie, Pili Ferrer, Amandine Gouverneur, Damien Driot, Shoma Berkemeyer, Xavier Vidal, Maria José Martínez-Zapata, Consuelo Huerta, Xavier Castells, Marietta Rottenkolber, Sven Schmiedl, Mònica Sabaté, Elena Ballarín, Luisa Ibáñez
OBJECTIVE: To develop and validate an adequate tool to evaluate the risk of bias of randomized controlled trials, observational studies, and systematic reviews assessing drug adverse events. STUDY DESIGN AND SETTING: We developed a structured risk of bias checklist applicable to randomized trials, cohort, case-control and nested case-control studies, and systematic reviews focusing on drug safety. Face and content validity was judged by three experienced reviewers...
May 6, 2017: Journal of Clinical Epidemiology
Jos Verbeek, Sharea Ijaz, Christina Mischke
OBJECTIVES: The objective of this study was to survey how outcomes in recent Cochrane reviews were defined and used for inclusion of studies and how this compares with guidance on preventing outcome reporting bias. STUDY DESIGN AND SETTING: A survey of Cochrane reviews. We extracted data on the outcomes and how the outcomes were used for inclusion of studies in the review. RESULTS: We included 52 reviews with a mean of 8.4 (standard deviation, 4...
May 4, 2017: Journal of Clinical Epidemiology
Juan Jose Yepes Nuñez, Yuan Zhang, Feng Xie, Pablo Alonso-Coello, Anna Selva, Holger Schünemann, Gordon Guyatt
OBJECTIVE: In systematic reviews of studies of patients' values and preferences, to summarize items and domains authors have identified when considering the risk of bias associated with primary studies. STUDY DESIGN AND SETTING: We conducted a systematic survey of systematic reviews of patients' values and preference studies. Our search included three databases (MEDLINE, EMBASE, and PsycINFO) from their inception to August 2015. We conducted duplicate data extraction, focusing on items that authors used to address risk of bias in the primary studies included in their reviews, and the associated underlying domains, and summarized criteria in descriptive tables...
May 3, 2017: Journal of Clinical Epidemiology
Adam J Streeter, Nan Xuan Lin, Louise Crathorne, Marcela Haasova, Christopher Hyde, David Melzer, William E Henley
OBJECTIVE: Motivated by recent calls to use electronic health records for research, we reviewed the application and development of methods for addressing the bias from unmeasured confounding in longitudinal data. DESIGN: Methodological review of existing literature SETTING: We searched MEDLINE and EMBASE for articles addressing the threat to causal inference from unmeasured confounding in nonrandomised longitudinal health data through quasi-experimental analysis...
April 28, 2017: Journal of Clinical Epidemiology
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