Harms of outcome switching in reports of randomised trials: CONSORT perspective

Altman, Douglas G.; Moher, David; Schulz, Kenneth F.

doi:10.1136/bmj.j396

Cited by 30 publications

(23 citation statements)

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“…Flexibility in data analysis is especially visible when the same community reports the same outcome variable but computes the value of this variable in different ways across the paper (e.g. www.flexiblemeasures.com; Carp, 2012; Francis, 2013) or when clinical trials switch their outcomes (Altman et al, 2017; Goldacre et al, 2019).…”

Section: Flexibility Of Analysis: P-hackingmentioning

confidence: 99%

Ten common statistical mistakes to watch out for when writing or reviewing a manuscript

Makin

Xivry

2019

eLife

186

161

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Inspired by broader efforts to make the conclusions of scientific research more robust, we have compiled a list of some of the most common statistical mistakes that appear in the scientific literature. The mistakes have their origins in ineffective experimental designs, inappropriate analyses and/or flawed reasoning. We provide advice on how authors, reviewers and readers can identify and resolve these mistakes and, we hope, avoid them in the future.

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Section: Flexibility Of Analysis: P-hackingmentioning

confidence: 99%

Ten common statistical mistakes to watch out for when writing or reviewing a manuscript

Makin

Xivry

2019

eLife

186

161

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“…To allow readers to assess the risk of bias from outcome switching, authors should also identify any changes to level of importance (e.g. primary or secondary) [ 77 ]. Authors should provide the rationale for any changes made and state whether these were done before or after collecting the data.…”

Section: Resultsmentioning

confidence: 99%

CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials

Grant

Mayo‐Wilson

Montgomery

et al. 2018

Trials

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BackgroundThe CONSORT (Consolidated Standards of Reporting Trials) Statement was developed to help biomedical researchers report randomised controlled trials (RCTs) transparently. We have developed an extension to the CONSORT 2010 Statement for social and psychological interventions (CONSORT-SPI 2018) to help behavioural and social scientists report these studies transparently.MethodsFollowing a systematic review of existing reporting guidelines, we conducted an online Delphi process to prioritise the list of potential items for the CONSORT-SPI 2018 checklist identified from the systematic review. Of 384 international participants, 321 (84%) participated in both rating rounds. We then held a consensus meeting of 31 scientists, journal editors, and research funders (March 2014) to finalise the content of the CONSORT-SPI 2018 checklist and flow diagram.ResultsCONSORT-SPI 2018 extends 9 items (14 including sub-items) from the CONSORT 2010 checklist, adds a new item (with 3 sub-items) related to stakeholder involvement in trials, and modifies the CONSORT 2010 flow diagram. This Explanation and Elaboration (E&E) document is a user manual to enhance understanding of CONSORT-SPI 2018. It discusses the meaning and rationale for each checklist item and provides examples of complete and transparent reporting.ConclusionsThe CONSORT-SPI 2018 Extension, this E&E document, and the CONSORT website (www.consort-statement.org) are helpful resources for improving the reporting of social and psychological intervention RCTs.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2735-z) contains supplementary material, which is available to authorized users.

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“…Although this correspondence focuses only on one recent paper, these analytic concerns and related issues remain rampant in clinical research [2,3] Table 3 in [1]…”

Section: Dear Editormentioning

confidence: 99%

The need for precise answers for the goals of precision medicine in alcohol dependence to succeed

Bradford

Fronk

Sant'Ana

et al. 2018

Neuropsychopharmacol

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Harms of outcome switching in reports of randomised trials: CONSORT perspective

Abstract: The outcomes reported for trials often differ from those specified in the protocol. Douglas Altman, David Moher, and Kenneth Schulz call for journals to do more to ensure that authors follow guidelines

Cited by 30 publications

References 7 publications

Ten common statistical mistakes to watch out for when writing or reviewing a manuscript

Ten common statistical mistakes to watch out for when writing or reviewing a manuscript

CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials

The need for precise answers for the goals of precision medicine in alcohol dependence to succeed

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