Why the ethical justification of randomized clinical trials is a scientific question
In 21st century medical research, randomized controlled trials (RCTs) are considered to generate the most useful form of medical knowledge [1]. This is because they are perceived to be a uniquely efficient and reliable way of uncovering causal knowledge about very complex systems and processes. However, the centrality of RCTs to modern medical research does not guarantee that all such trials will, therefore, be ethically justified, nor that RCTs are always required to answer any meaningful clinical research question. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 3, 2018 Category: Epidemiology Authors: Michel Shamy, Mark Fedyk Tags: Commentary Source Type: research

Many randomized clinical trials may not be justified: a cross-sectional analysis of the ethics and science of randomized clinical trials
We have proposed that three scientific criteria are important for the ethical justification of randomized clinical trials (RCTs): (1) they should be designed around a clear hypothesis; (2) uncertainty should exist around that hypothesis; (3) that uncertainty should be as established through a systematic review. We hypothesized that the majority of a sample of recently published RCTs would not explicitly incorporate these criteria, therefore rendering them potentially unjustified on scientific grounds. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 3, 2018 Category: Epidemiology Authors: Julie De Meulemeester, Mark Fedyk, Lucas Jurkovic, Michael Reaume, Dar Dowlatshahi, Grant Stotts, Michel Shamy Tags: Original Article Source Type: research

Controversy and debate on dengue vaccine series —paper 2: response to review of a licensed dengue vaccine: inappropriate subgroup analyses and selective reporting may cause harm in mass vaccination programs
We would like to provide our comments on Dans et  al. “Review of a licensed dengue vaccine: Inappropriate subgroup analyses and selective reporting may cause harm in mass vaccination programs”: (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 3, 2018 Category: Epidemiology Authors: Sri Rezeki S. Hadinegoro, Jose Luis Arredondo-Garc ía, Maria Rosario Capeding, Sophie Pallardy, Fernando Noriega, Alain Bouckenooghe Tags: Controversy and Debate on Dengue Vaccine Series Source Type: research

Controversy and debate on dengue vaccine series —paper 3: final response to review of a licensed dengue vaccine: inappropriate subgroup analyses and selective reporting may cause harm in mass vaccination programs
In their response to our critique [1] of their article, Hadinegoro et  al. question us on three issues [2]. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 3, 2018 Category: Epidemiology Authors: Antonio L. Dans, Leonila F. Dans, Mary Ann D. Lansang, Maria Asuncion A. Silvestre, Gordon H. Guyatt Tags: Controversy and Debate on Dengue Vaccine Series Source Type: research

Many randomized clinical trials may not be justified: a cross-sectional analysis of the ethics and science of randomized clinical trials
We have proposed that three scientific criteria are important for the ethical justification of randomized clinical trials (RCTs): (1) they should be designed around a clear hypothesis; (2) uncertainty should exist around that hypothesis; (3) that uncertainty should be as established through a systematic review. We hypothesized that the majority of a sample of recently published RCTs would not explicitly incorporate these criteria, therefore rendering them potentially unjustified on scientific grounds. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 3, 2018 Category: Epidemiology Authors: Julie De Meulemeester, Mark Fedyk, Lucas Jurkovic, Michael Reaume, Dar Dowlatshahi, Grant Stotts, Michel Shamy Tags: Original Article Source Type: research

Letter of response to the article by Dans et al entitled “Review of a licensed dengue vaccine: inappropriate subgroup analyses and selective reporting may cause harm in mass vaccination programs”
We would like to provide our comments on Dans et  al. “Review of a licensed dengue vaccine: Inappropriate subgroup analyses and selective reporting may cause harm in mass vaccination programs”: (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 3, 2018 Category: Epidemiology Authors: Sri Rezeki S. Hadinegoro, Jose Luis Arredondo-Garc ía, Maria Rosario Capeding, Sophie Pallardy, Fernando Noriega, Alain Bouckenooghe Tags: Letter to the Editor Source Type: research

Controversy and debate on dengue vaccine —paper 3: final response to Review of a licensed dengue vaccine: Inappropriate subgroup analyses and selective reporting may cause harm in mass vaccination programs
In their response to our critique [1] of their article, Hadinegoro et  al. question us on three issues [2]. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 3, 2018 Category: Epidemiology Authors: Antonio L. Dans, Leonila F. Dans, Mary Ann D. Lansang, Maria Asuncion A. Silvestre, Gordon H. Guyatt Tags: Letter to the Editor Source Type: research

Why the Ethical Justification of Randomized Clinical Trials is a Scientific Question
(Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 3, 2018 Category: Epidemiology Authors: Michel Shamy, Mark Fedyk Source Type: research

Many RCTs May Not Be Justified: A Cross-Sectional Analysis of the Ethics and Science of Randomized Clinical Trials
We have proposed that three scientific criteria are important to the ethical justification of RCTs: (1) they should be designed around a clear hypothesis; (2) uncertainty should exist around that hypothesis; (3) that uncertainty should be as established through a systematic review. We hypothesized that the majority of a sample of recently-published RCTs would not explicitly incorporate these criteria, therefore rendering them potentially unjustified on scientific grounds. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 3, 2018 Category: Epidemiology Authors: Julie De Meulemeester, Mark Fedyk, Lucas Jurkovic, Michael Reaume, Dar Dowlatshahi, Grant Stotts, Michel Shamy Source Type: research

Controversy and Debate on Dengue Vaccine - Paper 2: Response to Review of a licensed dengue vaccine: Inappropriate subgroup analyses and selective reporting may cause harm in mass vaccination programs
(Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 3, 2018 Category: Epidemiology Authors: Sri Rezeki S. Hadinegoro, Jose Luis Arredondo-Garc ía, Maria Rosario Capeding, Sophie Pallardy, Fernando Noriega, Alain Bouckenooghe Source Type: research

Controversy and Debate on Dengue Caccine - Paper 3: Final response to Review of a licensed dengue vaccine: Inappropriate subgroup analyses and selective reporting may cause harm in mass vaccination programs
(Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 3, 2018 Category: Epidemiology Authors: Antonio L. Dans, Leonila F. Dans, Mary Ann D. Lansang, Maria Asuncion A. Silvestre, Gordon H. Guyatt Source Type: research

Editorial Board
(Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 1, 2018 Category: Epidemiology Source Type: research

Table of Contents
(Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 1, 2018 Category: Epidemiology Source Type: research

Scientific integrity includes the rigour of the methods
In their Commentary Wallach, Gonsalves and Ross from Yale lay out a pragmatic and useful classification of scientific integrity that focusses on three areas highly relevant to clinical epidemiology investigators – research, regulatory and clinical decision. The regulatory ones are well known but the research and clinical decision making ones are less commonly included in research ethics courses. Poor methods and poor quality clinical guidelines should indeed be cause for ethical concern given the damage t hat can result. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 1, 2018 Category: Epidemiology Authors: Peter Tugwell, J. Andr é Knottnerus Tags: Editorial Source Type: research

Reporting of declarations and conflicts of interest in WHO guidelines can be further improved
We aimed to examine the declaration of interests (DOIs), management of conflict of interest (COI), and the funders for World Health Organization (WHO) guidelines. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 29, 2017 Category: Epidemiology Authors: Xiaoqin Wang, Yaolong Chen, Liang Yao, Qi Zhou, Qiongfang Wu, Janne Estill, Qi Wang, Kehu Yang, Susan L. Norris Tags: Review Source Type: research

Retrospective assessment of resource use and costs in two investigator-initiated randomized trials exemplified a comprehensive cost item list
Randomized clinical trials (RCTs) are costly and published information on resource requirements for their conduct is limited. To identify key factors for making RCTs more sustainable, empirical data on resource use and associated costs are needed. We aimed to retrospectively assess resource use and detailed costs of two academic, investigator-initiated RCTs using a comprehensive list of cost items. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 29, 2017 Category: Epidemiology Authors: Benjamin Speich, Belinda von Niederh äusern, Claudine Angela Blum, Jennifer Keiser, Nadine Schur, Thomas Fürst, Benjamin Kasenda, Mirjam Christ-Crain, Lars G. Hemkens, Christiane Pauli-Magnus, Matthias Schwenkglenks, Matthias Briel, MAking Randomized Tr Tags: Original Article Source Type: research

Declarations and conflicts of interest in WHO guidelines
We aimed to examine the declaration of interests (DOI), management of conflict of interest (COI), and the funders for World Health Organization (WHO) guidelines. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 29, 2017 Category: Epidemiology Authors: Xiaoqin Wang, Yaolong Chen, Liang Yao, Qi Zhou, Qiongfang Wu, Janne Estill, Qi Wang, Kehu Yang, Susan L. Norris Source Type: research

Retrospective assessment of resource use and costs in two investigator-initiated randomised trials exemplified a comprehensive cost item list
Randomised clinical trials (RCTs) are costly and published information on resource requirements for their conduct is limited. To identify key factors for making RCTs more sustainable, empirical data on resource use and associated costs are needed. We aimed to retrospectively assess resource use and detailed costs of two academic, investigator-initiated RCTs using a comprehensive list of cost items. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 29, 2017 Category: Epidemiology Authors: Benjamin Speich, Belinda von Niederh äusern, Claudine Angela Blum, Jennifer Keiser, Nadine Schur, Thomas Fürst, Benjamin Kasenda, Mirjam Christ-Crain, Lars G. Hemkens, Christiane Pauli-Magnus, Matthias Schwenkglenks, Matthias Briel, MAking Randomized Tr Source Type: research

Extraction of unadjusted estimates of prognostic association for meta-analysis: simulation methods as good alternatives to trend and direct method estimation
Systematic reviews and meta-analysis are the standard methods to assess the association between prognostic markers and major events/conditions. However, the summary measures reported are not always explicitly presented and therefore different indirect methods of extracting estimates have been proposed. The aim of this study is to present two new alternative methods for obtaining summary statistics to be included in a meta-analysis of prognostic studies based on simulating individual patient data and to compare them with the already known generalized least squares for trend (glst) estimation method and direct method. (Sourc...
Source: Journal of Clinical Epidemiology - December 28, 2017 Category: Epidemiology Authors: T. P érez, J. McLellan, R. Perera Tags: Original Article Source Type: research

Choice of treatment-effect measures when noninferiority margins originally defined in absolute difference translated into relative difference influenced the results of clinical trials
The aim of this study was to investigate the use of three treatment-effect measures in the analysis of randomized trials using a time-to-event endpoint and assess their influence on the results. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 28, 2017 Category: Epidemiology Authors: Xianmixikemaier Abulizi, Philippe Flandre Tags: Original Article Source Type: research

Unravelling complex primary-care programs to maintain independent living in older people: a systematic overview
Complex interventions are criticized for being a “black box”, which makes it difficult to determine why they succeed or fail. Recently, nine proactive primary-care programs aiming to prevent functional decline in older adults showed inconclusive effects. The aim of this study was to systematically unravel, compare, and synthesize the developme nt and evaluation of nine primary-care programs within a controlled trial to further improve the development and evaluation of complex interventions. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 28, 2017 Category: Epidemiology Authors: Linda C. Smit, Marieke J. Schuurmans, Jeanet W. Blom, Isabelle N. Fabbricotti, Aaltje P.D. Jansen, Gertrudis I.J.M. Kempen, Raymond Koopmans, Willemijn M. Looman, Rene J.F. Melis, Silke F. Metzelthin, Eric P. Moll van Charante, Maaike E. Muntinga, Franca Tags: Original Article Source Type: research

Technology-assisted risk of bias assessment in systematic reviews: A prospective cross-sectional evaluation of the RobotReviewer machine learning tool
To evaluate the reliability of RobotReviewer ’s risk of bias judgments. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 28, 2017 Category: Epidemiology Authors: Allison Gates, Ben Vandermeer, Lisa Hartling Source Type: research

Unravelling complex primary care programmes to maintain independent living in older people: a systematic overview
Complex interventions are criticized for being a ‘black box’, which makes it difficult to determine why they succeed or fail. Recently, nine proactive primary care programmes aiming to prevent functional decline in older adults showed inconclusive effects. The aim of this study was to systematically unravel, compare and synthesize the developm ent and evaluation of nine primary care programs within a controlled trial to further improve the development and evaluation of complex interventions. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 28, 2017 Category: Epidemiology Authors: L.C. Smit, M.J. Schuurmans, J.W. Blom, I.N. Fabbricotti, A.P.D. Jansen, G.I.J.M. Kempen, R. Koopmans, W.M. Looman, R.J.F. Melis, S.F. Metzelthin, E.P. Moll van Charante, M.E. Muntinga, F.G.H. Ruikes, S.L.W. Spoorenberg, J.J. Suijker, K. Wynia, J. Gusseklo Source Type: research

Extraction of Unadjusted Estimates of Prognostic Association for Meta-Analysis: Simulation Methods as Good Alternatives to Trend and Direct Method Estimation
Systematic reviews and meta-analysis are the standard methods to assess the association between prognostic markers and major events/conditions. However, the summary measures reported are not always explicitly presented and therefore different indirect methods of extracting estimates have been proposed. The aim of this study is to present two new alternative methods for obtaining summary statistics to be included in a meta-analysis of prognostic studies based on simulating individual patient data and to compare them with the already known generalized least squares for trend estimation method and direct method. (Source: Jour...
Source: Journal of Clinical Epidemiology - December 28, 2017 Category: Epidemiology Authors: T. P érez, J. McLellan, R. Perera Source Type: research

A systematic decision-making process on the need for updating clinical practice guidelines proved to be feasible in a pilot study
The objective of this study was to test and evaluate a new decision-making process on the need for updating within the update of a German clinical practice guideline (CPG). (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 28, 2017 Category: Epidemiology Authors: Monika Becker, Thomas Jaschinski, Michaela Eikermann, Tim Mathes, Stefanie B ühn, Wolfgang Koppert, Andreas Leffler, Edmund Neugebauer, Dawid Pieper Source Type: research

Choice of treatment effect measures when non-inferiority margins originally defined in absolute difference translated into relative difference influenced the results of clinical trials
The aim of this study was to investigate the use of three treatment effect measures in the analysis of randomized trials using a time-to-event endpoint and assess their influence on the results. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 28, 2017 Category: Epidemiology Authors: Xianmixikemaier Abulizi, Philippe Flandre Source Type: research

A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery
There is increasing recognition that insufficient attention has been paid to the choice of outcomes measured in clinical trials.The lack of a standardised outcome classification system results in inconsistencies due to ambiguity and variation in how outcomes are described across different studies. Being able to classify by outcome would increase efficiency in searching sources such as clinical trials registries, patient registries, the Cochrane Database of Systematic Reviews and the COMET (Core Outcome Measures in Effectiveness Trials) database of core outcome sets (COS), thus aiding knowledge discovery. (Source: Journal o...
Source: Journal of Clinical Epidemiology - December 27, 2017 Category: Epidemiology Authors: Susanna Dodd, Mike Clarke, Lorne Becker, Chris Mavergames, Rebecca Fish, Paula R. Williamson Source Type: research

Cochrane systematic reviews of interventions for risk factors correlate weakly with global risk factor burden: a cross-sectional study
Systematic reviews (SRs) are important for health-care decision-makers requiring evidence for interventions that target modifiable risk factors to prevent disease. We investigated whether Cochrane SR output correlated with risk factor burden as assessed by the Global Burden of Disease Study  2015. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 26, 2017 Category: Epidemiology Authors: David J. Roberts, John Cafferkey, Emma Plugge Tags: Original Article Source Type: research

Efforts to retrieve individual participant data sets for use in a meta-analysis result in moderate data sharing but many data sets remain missing
Individual participant data (IPD) meta-analysis synthesizes primary study data sets or the combination of primary study data sets with aggregate data (e.g., means and standard deviations [SDs]) from individual studies. Relative to traditional aggregate-data-only meta-analyses, an IPD meta-analysis has several advantages: reduction in ecological biases, improved power, the ability to test subgroups or moderators available only using IPD, and the completion and validation of meta-analytic databases [1,2]. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 26, 2017 Category: Epidemiology Authors: Joshua R. Polanin Tags: Brief Report Source Type: research

Systematic review on costs and resource use of randomized clinical trials shows a lack of transparent and comprehensive data
Randomized clinical trials (RCTs) are costly. We aimed to provide a systematic overview of the available evidence on resource use and costs for RCTs to support budget planning. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 26, 2017 Category: Epidemiology Authors: Benjamin Speich, Belinda von Niederh äusern, Nadine Schur, Lars G. Hemkens, Thomas Fürst, Neera Bhatnagar, Reem Alturki, Arnav Agarwal, Benjamin Kasenda, Christiane Pauli-Magnus, Matthias Schwenkglenks, Matthias Briel, MAking Randomized Trials Affordabl Tags: Review Source Type: research

Systematic review of current guideline appraisals performed with the Appraisal of Guidelines for Research & Evaluation II instrument —a third of AGREE II users apply a cut-off for guideline quality
To investigate whether Appraisal of Guidelines for Research& Evaluation (AGREE) II users apply a cut-off based on standardized domain scores or overall guideline quality to distinguish between high- and low-quality guidelines, as well as to investigate which criteria they use to generate this cut-off and which type of cut-off they apply. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 26, 2017 Category: Epidemiology Authors: Wiebke Hoffmann-E ßer, Ulrich Siering, Edmund A.M. Neugebauer, Ulrike Lampert, Michaela Eikermann Tags: Original Article Source Type: research

Efforts to retrieve individual participant data sets for use in a meta-analysis result in moderate data sharing but many data sets remain missing
Individual participant data (IPD) meta-analysis synthesizes primary study data sets or the combination of primary study data sets with aggregate data (e.g., means and standard deviations [SDs]) from individual studies. Relative to traditional aggregate-data-only meta-analyses, an IPD meta-analysis has several advantages: reduction in ecological biases, improved power, the ability to test subgroups or moderators available only using IPD, and the completion and validation of meta-analytic databases [1,2]. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 26, 2017 Category: Epidemiology Authors: Joshua R. Polanin Tags: Brief Report Source Type: research

Bootstrap imputation minimized misclassification bias when measuring  Colles' fracture prevalence and its associations using health administrative data
This study quantified misclassification bias in the study of Colles' fracture. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 26, 2017 Category: Epidemiology Authors: Carl van Walraven Tags: Original Article Source Type: research

Bootstrap imputation minimized misclassification bias when measuring Colles ’ fracture prevalence and its associations using health administrative data
This study quantified misclassification bias in the study of Colles ’ fracture. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 26, 2017 Category: Epidemiology Authors: Carl van Walraven Source Type: research

A prospective cohort and extended comprehensive-cohort design provided insights about the generalizability of a pragmatic trial: the ProtecT prostate cancer trial
Randomized controlled trials (RCTs) deliver robust internally valid evidence but generalizability is often neglected. Design features built into the ProtecT RCT of treatments for localized prostate cancer (PCa) provided insights into its generalizability. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 26, 2017 Category: Epidemiology Authors: Jenny L. Donovan, Grace J. Young, Eleanor I. Walsh, Chris Metcalfe, J. Athene Lane, Richard M. Martin, Marta K. Tazewell, Michael Davis, Tim. J. Peters, Emma L. Turner, Nicola Mills, Hanan Khazragui, Tarnjit K. Khera, David E. Neal, Freddie C. Hamdy, Prot Source Type: research

Cochrane systematic reviews of interventions for risk factors correlate weakly with global risk factor burden: A cross-sectional study
Systematic reviews (SRs) are important for healthcare decision makers requiring evidence for interventions that target modifiable risk factors to prevent disease. We investigated whether Cochrane SR output correlated with risk factor burden as assessed by the Global Burden of Disease Study 2015. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 26, 2017 Category: Epidemiology Authors: David J. Roberts, John Cafferkey, Emma Plugge Source Type: research

Is there a cut-off for high-quality guidelines? A systematic analysis of current guideline appraisals using the AGREE II instrument
To investigate whether AGREE II users apply a cut-off based on standardized domain scores or overall guideline quality in order to distinguish between high- and low-quality guidelines, as well as to investigate which criteria they use to generate this cut-off and which type of cut-off they apply. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 26, 2017 Category: Epidemiology Authors: Wiebke Hoffmann-E ßer, Ulrich Siering, Edmund A.M. Neugebauer, Ulrike Lampert, Michaela Eikermann Source Type: research

Systematic review on costs and resource use of randomised clinical trials shows a lack of transparent and comprehensive data
Randomised clinical trials (RCTs) are costly. We aimed to provide a systematic overview of the available evidence on resource use and costs for RCTs to support budget planning. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 26, 2017 Category: Epidemiology Authors: Benjamin Speich, Belinda von Niederh äusern, Nadine Schur, Lars G. Hemkens, Thomas Fürst, Neera Bhatnagar, Reem Alturki, Arnav Agarwal, Benjamin Kasenda, Christiane Pauli-Magnus, Matthias Schwenkglenks, Matthias Briel, MAking Randomized Trials Affordabl Source Type: research

Efforts to Retrieve Individual Participant Datasets for Use in a Meta-Analysis Result in Moderate Data Sharing but Many Datasets Remain Missing
(Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 26, 2017 Category: Epidemiology Authors: Joshua R. Polanin Source Type: research

Fostering responsible research practices is a shared responsibility of multiple stakeholders
(Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 21, 2017 Category: Epidemiology Authors: Lex M. Bouter Source Type: research

The cohort multiple randomized controlled trial design was found to be highly susceptible to low statistical power and internal validity biases
The “cohort multiple randomized controlled trial” (cmRCT) is a recent innovation by which novel interventions are trialed within large longitudinal cohorts of patients to gain efficiencies and align trials more closely to standard clinical practice. The use of cmRCTs is outpacing its methodological understanding, and more appropriate methods for designing and analyzing such trials are urgently needed. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 19, 2017 Category: Epidemiology Authors: David Reeves, Kelly Howells, Mark Sidaway, Amy Blakemore, Mark Hann, Maria Panagioti, Peter Bower Tags: Original Article Source Type: research

The Cohort Multiple Randomised Controlled Trial (cmRCTs) design was found to be highly susceptible to low statistical power and internal validity biases
The ‘cohort multiple randomized controlled trial’ (cmRCT) is a recent innovation by which novel interventions are trialled within large longitudinal cohorts of patients to take gain efficiencies and align trials more closely to standard clinical practice. The use of cmRCTs is outpacing methodologica l understanding of them and more appropriate methods for designing and analysing such trials are urgently needed. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 19, 2017 Category: Epidemiology Authors: David Reeves, Kelly Howells, Mark Sidaway, Amy Blakemore, Mark Hann, Maria Panagioti, Peter Bower Source Type: research

Unreported links between trial registrations and published articles were identified using document similarity measures in a cross-sectional analysis of ClinicalTrials.gov
Trial registries can be used to measure reporting biases and support systematic reviews but 45% of registrations do not provide a link to the article reporting on the trial. We evaluated the use of document similarity methods to identify unreported links between ClinicalTrials.gov and PubMed. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 19, 2017 Category: Epidemiology Authors: Adam G. Dunn, Enrico Coiera, Florence T. Bourgeois. Source Type: research

No difference in knowledge obtained from infographic or plain language summary of a Cochrane systematic review: three randomized controlled trials
The aim of this study was to test the usefulness of an infographic in the translation of knowledge about health information from a Cochrane systematic review to lay and professional populations in comparison to a plain language summary (PLS) and scientific abstract (SA). (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 18, 2017 Category: Epidemiology Authors: Ivan Buljan, Mario Mali čki, Elizabeth Wager, Livia Puljak, Darko Hren, Frances Kellie, Helen West, Žarko Alfirević, Ana Marušić Tags: ORIGINAL ARTICLE Source Type: research

No difference in knowledge obtained from infographic or plain language summary of a Cochrane systematic review: three randomized controlled trials
The aim of this study was to test the usefulness of an infographic in the translation of knowledge about health information from a Cochrane systematic review to lay and professional populations in comparison to a plain language summary and scientific abstract. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 18, 2017 Category: Epidemiology Authors: Ivan Buljan, Mario Mali čki, Elizabeth Wager, Livia Puljak, Darko Hren, Frances Kellie, Helen West, Žarko Alfirević, Ana Marušić Source Type: research

Linear regression and the normality assumption
Researchers often perform arbitrary outcome transformations to fulfill the normality assumption of a linear regression model. This commentary explains and illustrates that in large data settings, such transformations are often unnecessary, and worse may bias model estimates. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 16, 2017 Category: Epidemiology Authors: Amand F. Schmidt, Chris Finan Tags: Commentary Source Type: research

Systematic reviews with published protocols compared to those without: more effort, older search
To explore trends in published protocols of systematic reviews (SRs) and to analyse how SRs with published protocols differ from those without. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 16, 2017 Category: Epidemiology Authors: Katharina Allers, Falk Hoffmann, Tim Mathes, Dawid Pieper Source Type: research

Linear regression and the normality assumption
Researchers often perform arbitrary outcome transformations to fulfil the normality assumption of a linear regression model. This manuscript explains and illustrates that in large data settings, such transformations are often unnecessary, and worse, may bias model estimates. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 16, 2017 Category: Epidemiology Authors: A.F. Schmidt, Chris Finan Source Type: research

A retrospective comparison of systematic reviews with same-topic rapid reviews
To compare rapid reviews to same-topic systematic reviews for methods, studies included, and conclusions. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 16, 2017 Category: Epidemiology Authors: Emily Reynen, Reid Robson, John Ivory, Jeremiah Hwee, Sharon E. Straus, Ba ’ Pham, Andrea C. Tricco Source Type: research

Cochrane Qualitative and Implementation Methods Group guidance series —paper 2: methods for question formulation, searching, and protocol development for qualitative evidence synthesis
This paper updates previous Cochrane guidance on question formulation, searching, and protocol development, reflecting recent developments  in methods for conducting qualitative evidence syntheses to inform Cochrane intervention reviews. Examples are used to illustrate how decisions about boundaries for a review are formed via an iterative process of constructing lines of inquiry and mapping the available information to ascertain whet her evidence exists to answer questions related to effectiveness, implementation, feasibility, appropriateness, economic evidence, and equity. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - December 14, 2017 Category: Epidemiology Authors: Janet L. Harris, Andrew Booth, Margaret Cargo, Karin Hannes, Angela Harden, Kate Flemming, Ruth Garside, Tomas Pantoja, James Thomas, Jane Noyes Tags: Cochrane Qualitative and Implementation Methods Group Guidance Series Source Type: research