Journal ArticleDOI
Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials.
TLDR
Examining the architecture of the entire set of subgroups within a trial, analyzing similar subgroups across independent trials, and interpreting the evidence in the context of known biologic mechanisms and patient prognosis are recommended.Abstract:
A key principle for interpretation of subgroup results is that quantitative interactions (differences in degree) are much more likely than qualitative interactions (differences in kind). Quantitative interactions are likely to be truly present whether or not they are apparent, whereas apparent qualitative interactions should generally be disbelieved as they have usually not been replicated consistently. Therefore, the overall trial result is usually a better guide to the direction of effect in subgroups than the apparent effect observed within a subgroup. Failure to specify prior hypotheses, to account for multiple comparisons, or to correct P values increases the chance of finding spurious subgroup effects. Conversely, inadequate sample size, classification of patients into the wrong subgroup, and low power of tests of interaction make finding true subgroup effects difficult. We recommend examining the architecture of the entire set of subgroups within a trial, analyzing similar subgroups across independent trials, and interpreting the evidence in the context of known biologic mechanisms and patient prognosis. ( JAMA . 1991;266:93-98)read more
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Cochrane Handbook for Systematic Reviews of Interventions
Julian P T Higgins,Sally Green +1 more
TL;DR: The Cochrane Handbook for Systematic Reviews of Interventions is the official document that describes in detail the process of preparing and maintaining Cochrane systematic reviews on the effects of healthcare interventions.
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Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients
TL;DR: Aspirin (or another oral antiplatelet drug) is protective in most types of patient at increased risk of occlusive vascular events, including those with an acute myocardial infarction or ischaemic stroke, unstable or stable angina, previous myocardian infarctions, stroke or cerebral ischaemia, peripheral arterial disease, or atrial fibrillation.
Journal ArticleDOI
CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials
David Moher,Sally Hopewell,Kenneth F. Schulz,Victor M. Montori,Peter C Gøtzsche,Philip J. Devereaux,Diana Elbourne,Matthias Egger,Douglas G. Altman +8 more
TL;DR: This update of the CONSORT statement improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition, such as selective outcome reporting bias.
Journal ArticleDOI
The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration
Douglas G. Altman,Kenneth F. Schulz,David Moher,Matthias Egger,Frank Davidoff,Diana Elbourne,Peter C Gøtzsche,Tom Lang +7 more
TL;DR: The Consort Statement as mentioned in this paper is a group of scientists and editors developed to improve the quality of reporting of randomized, controlled trials (RCTs) by providing guidance to authors about how to improve their reporting of their trials.
Chapter 9: Analysing Data and Undertaking Meta-Analyses
TL;DR: This extract is made available solely for use in the authoring, editing or refereeing of Cochrane reviews, or for training in these processes by representatives of formal entities of The Cochrane Collaboration.
References
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Simultaneous Statistical Inference
TL;DR: In this article, the authors presented a case of two means regression method for the family error rate, which was used to estimate the probability of a family having a nonzero family error.
Journal ArticleDOI
Beta blockade during and after myocardial infarction: an overview of the randomized trials
TL;DR: The aim has been not only to review the 65-odd randomized beta blocker trials but also to demonstrate that when many randomized trials have all applied one general approach to treatment, it is often not appropriate to base inference on individual trial results.
Journal ArticleDOI
Discrete sequential boundaries for clinical trials
K. K. Gordon Lan,David L. DeMets +1 more
TL;DR: In this article, the authors proposed a more flexible method to construct discrete sequential boundaries based on the choice of a function, a*(t), which characterizes the rate at which the error level ac is spent.
Journal ArticleDOI
TRIAL OF TISSUE PLASMINOGEN ACTIVATOR FOR MORTALITY REDUCTION IN ACUTE MYOCARDIAL INFARCTION: Anglo-Scandinavian Study of Early Thrombolysis (ASSET)
TL;DR: Subset analysis showed that patients who had a normal electrocardiogram (ECG) at the time of randomisation had a low case fatality rate and rt-PA was associated with a 24.5% relative reduction in 1 month fatality.
Journal ArticleDOI
Effect on mortality of metoprolol in acute myocardial infarction. A double-blind randomised trial.
Å Hjalmarson,Johan Herlitz,I Málek,Lars Rydén,Anders Vedin,Ann-Charlotte Waldenström,Hans Wedel,Dag Elmfeldt,Stig Holmberg,G Nyberg,Karl Swedberg,Finn Waagstein,J Waldenström,Lars Wilhelmsen,Claes Wilhelmsson +14 more
TL;DR: The effect of metoprolol on mortality was compared with that of placebo in a double blind randomised trial in patients with definite or suspected acute myocardial infarction and there was a reduction of 36% (p less than 0.03).