Public availability and adherence to pre-specified statistical analysis approaches was low in published randomised trials.
Sign Up to like & getrecommendations! Published in 2020 at "Journal of clinical epidemiology"
DOI: 10.1016/j.jclinepi.2020.07.015
Abstract: OBJECTIVE Pre-specification of statistical methods in clinical trial protocols and Statistical Analysis Plans (SAPs) can help to deter bias from p-hacking, but is only effective if the pre-specified approach is made available. STUDY DESIGN AND… read more here.
Keywords: pre specified; trial; analysis; statistical analysis ... See more keywords
Narrative bias ("spin") is common in randomised trials and systematic reviews of cannabinoids for pain.
Sign Up to like & getrecommendations! Published in 2024 at "Pain"
DOI: 10.1097/j.pain.0000000000003140
Abstract: ABSTRACT We define narrative bias as a tendency to interpret information as part of a larger story or pattern, regardless of whether the facts support the full narrative. Narrative bias in title and abstract means… read more here.
Keywords: trials systematic; title abstract; randomised trials; systematic reviews ... See more keywords
The financial impact of participant attrition from randomised trials: a case‐study from the Occupational Therapist Intervention Study (OTIS)
Sign Up to like & getrecommendations! Published in 2024 at "Journal of Evaluation in Clinical Practice"
DOI: 10.1111/jep.14212
Abstract: Abstract Rationale Loss to follow‐up of participants can compromise the statistical validity of randomised trials. Moreover, it can have financial consequences for trial teams and funders. This study explores the Occupational Therapist Intervention Study (OTIS)… read more here.
Keywords: loss follow; randomised trials; trial; attrition ... See more keywords
Some methodological issues in the design and analysis of cluster randomised trials
Sign Up to like & getrecommendations! Published in 2018 at "British Journal of Sports Medicine"
DOI: 10.1136/bjsports-2018-099628
Abstract: Randomised trials are widely used for assessing the effect of interventions on outcomes, because on average randomisation balances covariates between treatment groups, even if those covariates are unobserved.1 2 In some situations, it is more… read more here.
Keywords: trial; cluster randomised; effect; randomised trials ... See more keywords
47 The impact of applying both a critical statistical and a critical clinical appraisal to the randomised trials that form the cardiology revascularizatio nguidelines: implications for clinical practice
Sign Up to like & getrecommendations! Published in 2018 at "BMJ Evidence-Based Medicine"
DOI: 10.1136/bmjebm-2018-111024.47
Abstract: Objectives Randomised trials and guidelines are used by physicians, administrators, patients, and policy makers to make medical decisions. The assumption is that the randomised trial conclusions and the guideline recommendations are accurate and have been… read more here.
Keywords: statistical critical; trial; cardiology; critical statistical ... See more keywords
Efficacy and moderators of efficacy of trauma-focused cognitive behavioural therapies in children and adolescents: protocol for an individual participant data meta-analysis from randomised trials
Sign Up to like & getrecommendations! Published in 2021 at "BMJ Open"
DOI: 10.1136/bmjopen-2020-047212
Abstract: Introduction Trauma-focused cognitive behavioural therapies are the first-line treatment for posttraumatic stress disorder (PTSD) in children and adolescents. Nevertheless, open questions remain with respect to efficacy: why does this first-line treatment not work for everyone?… read more here.
Keywords: trauma focused; focused cognitive; analysis; cognitive behavioural ... See more keywords
Reporting quality for abstracts of randomised trials on child and adolescent depression prevention: a meta-epidemiological study on adherence to CONSORT for abstracts
Sign Up to like & getrecommendations! Published in 2022 at "BMJ Open"
DOI: 10.1136/bmjopen-2022-061873
Abstract: Objectives This study aimed to investigate adherence to Consolidated Standards of Reporting Trials (CONSORT) for abstracts in reports of randomised trials on child and adolescent depression prevention. Secondary objective was to examine factors associated with… read more here.
Keywords: randomised trials; trials child; child adolescent; depression ... See more keywords
Registry randomised trials: a methodological perspective
Sign Up to like & getrecommendations! Published in 2023 at "BMJ Open"
DOI: 10.1136/bmjopen-2022-068057
Abstract: Registry randomised clinical trials (RRCTs) have the potential to provide pragmatic answers to important clinical questions. RRCTs can be embedded into large population-based registries or smaller single site registries to provide timely answers at a… read more here.
Keywords: trials methodological; randomised trials; methodological perspective; registry randomised ... See more keywords
Reporting guidance considerations from a statistical perspective: overview of tools to enhance the rigour of reporting of randomised trials and systematic reviews
Sign Up to like & getrecommendations! Published in 2017 at "Evidence-Based Mental Health"
DOI: 10.1136/eb-2017-102666
Abstract: Objective Research waste has received considerable attention from the biomedical community. One noteworthy contributor is incomplete reporting in research publications. When detailing statistical methods and results, ensuring analytic methods and findings are completely documented improves… read more here.
Keywords: reporting; research; trials systematic; randomised trials ... See more keywords
Need for better reporting of trials with surrogate endpoints: SPIRIT|CONSORT-SURROGATE extensions
Sign Up to like & getrecommendations! Published in 2022 at "Journal of Epidemiology and Community Health"
DOI: 10.1136/jech-2022-219294
Abstract: Evidence for the effectiveness of health interventions should ideally come from randomised trials that assess a participant relevant final outcome (PRFO), such as health status or survival. 2 However, such trials often require large sample… read more here.
Keywords: surrogate endpoints; health; randomised trials; reporting trials ... See more keywords
Informed consent in cluster randomised trials: new and common ethical challenges
Sign Up to like & getrecommendations! Published in 2017 at "Journal of Medical Ethics"
DOI: 10.1136/medethics-2017-104249
Abstract: Cluster randomised trials are an increasingly important methodological tool in health research but they present challenges to the informed consent requirement. In the relatively limited literature on the ethics of cluster research there is not… read more here.
Keywords: research; cluster randomised; randomised trials; consent ... See more keywords