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GRADE Guidelines 28: Use of GRADE for the assessment of evidence about prognostic factors: rating certainty in identification of groups of patients with different absolute risks
OBJECTIVE: The objective of this study was to provide guidance on the use of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to determine certainty in estimates ...
Foroutan et al. J. Clin. Epidemiol. 2020
Development of the Instrument to assess the Credibility of Effect Modification Analyses (ICEMAN) in randomized controlled trials and meta-analyses
BACKGROUND: Most randomized controlled trials (RCTs) and meta-analyses of RCTs examine effect modification (also called a subgroup effect or interaction), in which the effect of an intervention varies...
Schandelmaier et al. CMAJ 2020
Non-adherence in non-inferiority trials: pitfalls and recommendations
Mo et al. BMJ 2020
Treatment effects beyond the mean using distributional regression: Methods and guidance
This paper introduces distributional regression also known as generalized additive models for location, scale and shape (GAMLSS) as a modeling framework for analyzing treatment effects beyond the mean...
Hohberg et al. PLoS One 2020
Non-adherence in non-inferiority trials: pitfalls and recommendations
#VALUE!
Grading of Recommendations Assessment, Development, and Evaluations (GRADE) notes: extremely serious, GRADE's terminology for rating down by three levels
OBJECTIVES: The Grading of Recommendations Assessment, Development, and Evaluations (GRADE) system for assessing certainty in a body of evidence currently uses two levels, serious and very serious, fo...
Piggott et al. J. Clin. Epidemiol. 2020
Sample size calculation in randomised phase II selection trials using a margin of practical equivalence
BACKGROUND: In rare cancers or subtypes of common cancers, a comparison of multiple promising treatments may be required. The selected treatment can then be assessed against the standard of care (if i...
Dehbi et al. Trials 2020
Individual participant data meta-analysis to examine interactions between treatment effect and participant-level covariates: Statistical recommendations for conduct and planning
Precision medicine research often searches for treatment-covariate interactions, which refers to when a treatment effect (eg, measured as a mean difference, odds ratio, hazard ratio) changes across va...
Riley et al. Stat. Med. 2020
Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed
The evidence base available to trialists to support trial process decisions-e.g. how best to recruit and retain participants, how to collect data or how to share the results with participants-is thin....
Treweek et al. Trials 2020
GRADE guidelines 26: informative statements to communicate the findings of systematic reviews of interventions
OBJECTIVES: Clear communication of systematic review findings will help readers and decision makers. We built on previous work to develop an approach that improves the clarity of statements to convey ...
Santesso et al. J. Clin. Epidemiol. 2020
Sensitivity analysis for clinical trials with missing continuous outcome data using controlled multiple imputation: A practical guide
Missing data due to loss to follow-up or intercurrent events are unintended, but unfortunately inevitable in clinical trials. Since the true values of missing data are never known, it is necessary to ...
Cro et al. Stat. Med. 2020
A conceptual framework for prognostic research
BACKGROUND: Prognostic research has many important purposes, including (i) describing the natural history and clinical course of health conditions, (ii) investigating variables associated with health ...
Kent et al. BMC Med. Res. Methodol. 2020
State of the art in selection of variables and functional forms in multivariable analysis-outstanding issues
Background: How to select variables and identify functional forms for continuous variables is a key concern when creating a multivariable model. Ad hoc 'traditional' approaches to variable selection h...
Sauerbrei et al. Diagn Progn Res 2020
Ten questions to consider when interpreting results of a meta-epidemiological study-the MetaBLIND study as a case
Randomized clinical trials underpin evidence-based clinical practice, but flaws in their conduct may lead to biased estimates of intervention effects and hence invalid treatment recommendations. The m...
Moustgaard et al. Res Synth Methods 2020
ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials Step 5
Committee et al. 2020
Synthesis without meta-analysis (SWiM) in systematic reviews: reporting guideline
In systematic reviews that lack data amenable to meta-analysis, alternative synthesis methods are commonly used, but these methods are rarely reported. This lack of transparency in the methods can cas...
Campbell et al. BMJ 2020
GRADE guidelines 27: how to calculate absolute effects for time-to-event outcomes in summary of findings tables and Evidence Profiles
OBJECTIVES: To provide GRADE guidance on how to prepare Summary of Findings tables and Evidence Profiles for time-to-event outcomes with a focus on the calculation of the corresponding absolute effect...
Skoetz et al. J. Clin. Epidemiol. 2020
GRADE guidelines: 21 part 2. Test accuracy: inconsistency, imprecision, publication bias, and other domains for rating the certainty of evidence and presenting it in evidence profiles and summary of findings tables
OBJECTIVES: This article provides updated GRADE guidance about how authors of systematic reviews and health technology assessments and guideline developers can rate the certainty of evidence (also kno...
Sch¸nemann et al. J. Clin. Epidemiol. 2020
GRADE guidelines: 21 part 1. Study design, risk of bias, and indirectness in rating the certainty across a body of evidence for test accuracy
OBJECTIVES: This article provides updated GRADE guidance about how authors of systematic reviews and health technology assessments and guideline developers can assess the results and the certainty of ...
Sch¸nemann et al. J. Clin. Epidemiol. 2020
The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design
Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may als...
Dimairo et al. BMJ 2020
A scoping review found increasing examples of rapid qualitative evidence syntheses and no methodological guidance
OBJECTIVES: The objective of the study was to identify existing methodological guidance for the conduct of rapid qualitative evidence syntheses and examples of rapid qualitative evidence syntheses to ...
Campbell et al. J. Clin. Epidemiol. 2019
A guidance was developed to identify participants with missing outcome data in randomized controlled trials
BACKGROUND AND OBJECTIVES: In order for authors of systematic reviews to address missing data in randomized controlled trials (RCTs), they need to first identify the number of trial participants with ...
Kahale et al. J. Clin. Epidemiol. 2019
Introducing the new CONSORT extension for stepped-wedge cluster randomised trials
The use of the stepped-wedge cluster randomised trial (SW-CRT) is on the increase, and although there are still relatively few SW-CRTs currently published its use is bound to show an increase in the n...
Hemming et al. Trials 2019
Guidance for reporting outcomes in clinical trials: scoping review protocol
INTRODUCTION: Patients, families and clinicians rely on published research to help inform treatment decisions. Without complete reporting of the outcomes studied, evidence-based clinical and policy de...
Butcher et al. BMJ Open 2019
Beyond interviews and focus groups: a framework for integrating innovative qualitative methods into randomised controlled trials of complex public health interventions
BACKGROUND: Randomised controlled trials (RCTs) are widely used for establishing evidence of the effectiveness of interventions, yet public health interventions are often complex, posing specific chal...
Davis et al. Trials 2019
Adherence to reporting guidelines increases the number of citations: the argument for including a methodologist in the editorial process and peer-review
BACKGROUND: From 2005 to 2010, we conducted 2 randomized studies on a journal (Medicina ClÌnica), where we took manuscripts received for publication and randomly assigned them to either the standard e...
VilarÛ et al. BMC Med. Res. Methodol. 2019
What are the most important unanswered research questions in trial retention? A James Lind Alliance Priority Setting Partnership: the PRioRiTy II (Prioritising Retention in Randomised Trials) study
BACKGROUND: One of the top three research priorities for the UK clinical trial community is to address the gap in evidence-based approaches to improving participant retention in randomised trials. Des...
Brunsdon et al. Trials 2019
Which design to evaluate complex interventions? Toward a methodological framework through a systematic review
BACKGROUND: Evaluation of complex interventions (CI) is challenging for health researchers and requires innovative approaches. The objective of this work is to present the main methods used to evaluat...
Minary et al. BMC Med. Res. Methodol. 2019
GRADE guidelines: 18. How ROBINS-I and other tools to assess risk of bias in nonrandomized studies should be used to rate the certainty of a body of evidence
Sch¸nemann et al. Journal of Clinical Epidemiology 2019
Improving reporting of meta-ethnography: the eMERGe reporting guidance
AIMS: The aim of this study was to provide guidance to improve the completeness and clarity of meta-ethnography reporting. BACKGROUND: Evidence-based policy and practice require robust evidence synthe...
France et al. BMC Med. Res. Methodol. 2019
Defining consensus opinion to develop randomised controlled trials in rare diseases using Bayesian design: An example of a proposed trial of adalimumab versus pamidronate for children with CNO/CRMO
INTRODUCTION: Chronic nonbacterial osteomyelitis (CNO) is a rare autoinflammatory bone disorder primarily affecting children and adolescents. It can lead to chronic pain, bony deformities and fracture...
Ramanan et al. PLoS One 2019
Strategies for eliciting and synthesizing evidence for guidelines in rare diseases
BACKGROUND: Rare diseases are a global public health priority. Though each disease is rare, when taken together the thousands of known rare diseases cause significant morbidity and mortality, impact q...
Pai et al. BMC Med. Res. Methodol. 2019
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