Allocation concealment versus blinding in randomised controlled trials

BMJ ◽  
2013 ◽  
Vol 347 (sep13 1) ◽  
pp. f5518-f5518 ◽  
Author(s):  
P. Sedgwick
Keyword(s):  
Randomised Controlled Trials ◽  
Allocation Concealment ◽  
Controlled Trials ◽  
Randomised Controlled

Assessment of Reporting Quality in Randomised Controlled Trials of Acupuncture for Post-Stroke Rehabilitation Using the Consort Statement and Stricta Guidelines

2017 ◽  
Vol 35 (2) ◽  
pp. 100-106 ◽  
Author(s):  
Jingchun Zeng ◽  
Guohua Lin ◽  
Lixia Li ◽  
Liming Lu ◽  
Chuyun Chen ◽  
...  
Keyword(s):  
Stroke Rehabilitation ◽  
Randomised Controlled Trials ◽  
Reporting Quality ◽  
Consort Statement ◽  
Allocation Concealment ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Post Stroke ◽  
Randomised Controlled

Objectives To evaluate the completeness of reporting of randomised controlled trials (RCTs) of acupuncture for post-stroke rehabilitation in order to provide information to facilitate transparent and more complete reporting of acupuncture RCTs in this field. Methods Multiple databases were searched from their inception through September 2015. Quality of reporting for included papers was assessed against a subset of criteria adapted from the Consolidated Standards for Reporting Trials (CONSORT) 2010 statement and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines. Each item was scored 1 if it was reported, or 0 if it was not clearly stated. Descriptive statistical analysis was performed. Cohen's κ-statistics were calculated to assess agreement between the two reviewers. Results A total of 87 RCTs were included in the full text. Based on CONSORT, good reporting was evident for items “Randomised’ in the title or abstract’, ‘Participants’, ‘Statistical methods’, ‘Recruitment’, ‘Baseline data’, and ‘Outcomes and estimation’, with positive rates >80%. However, the quality of reporting for the items ‘Trial design’, ‘Outcomes’, ‘Sample size’, ‘Allocation concealment’, ‘Implementation’, ‘Blinding’, ‘Flow chart’, ‘Intent-to-treat analysis’, and ‘Ancillary analyses’ was very poor with positive rates <10%. Based on STRICTA, the items ‘Number of needle insertions per subject per session’, ‘Responses sought’, and ‘Needle type’ had poor reporting with positive rates <50%. Substantial agreement was observed for most items and good agreement was observed for some items. Conclusions The reporting quality of RCTs in acupuncture for post-stroke rehabilitation is unsatisfactory and needs improvement.

scholarly journals Envelope use and reporting in randomised controlled trials: A guide for researchers

2020 ◽  
Vol 2 (1) ◽  
pp. 2-11
Author(s):  
Laura Clark ◽  
Alexandra Dean ◽  
Alex Mitchell ◽  
David J Torgerson
Keyword(s):  
Randomised Controlled Trials ◽  
Allocation Concealment ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Policy Makers ◽  
Increased Risk ◽  
Randomised Controlled ◽  
Methodological Aspects ◽  
Robust Evidence ◽  
Frequent Reason

Introduction To produce robust evidence RCTs need to be rigorously conducted as poorly performed studies introduce bias and can mislead clinicians and policy makers. Poor allocation concealment has the largest single impact on bias in RCTs than other methodological aspects. Envelopes are frequently used as a method of allocation concealment and can be associated with increased risk of bias. This paper aims to review envelope use in RCTs published in 2017–2018 and create a guide as a reference for researchers when planning and publishing RCTs when using envelopes as an allocation concealment method. Methods RCTs that used envelopes as a form of allocation concealment that were published in BMJ, JAMA, NEJM and The Lancet in 2017 and 2018 were identified and methodological data on their envelope use extracted and authors were contacted to ascertain reasons for using envelopes in their research. Results 338 RCTs were identified that were published in 2017 and 2018. 8% (n = 29) of the RCTs published used envelopes as an allocation concealment method. 24.1% (n = 7) of studies reported envelope studies robustly with all required methodological information stated to enable an assessment of quality. Budget was the most frequent reason given for envelope use (41.7%). Discussion Only 24% of published RCTs, that used envelopes, contained robust methodological information to enable the reader to judge whether the randomisation and allocation concealment method was adequate. Conclusion RCTs are not reporting envelope use well. RCTs using envelopes should be designed and reported clearly ensuring all necessary methodological information is included.

scholarly journals Exploring engagement with authors of randomised controlled trials to develop recommendations to improve allocation concealment implementation and reporting

F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 83
Author(s):  
Laura Clark ◽  
Natasha Mitchell ◽  
Catherine Hewitt ◽  
David Torgerson
Keyword(s):  
Peer Review ◽  
Methodological Quality ◽  
Randomised Controlled Trials ◽  
Response Rate ◽  
Reporting Quality ◽  
Allocation Concealment ◽  
Reporting Guidelines ◽  
Controlled Trials ◽  
Randomised Controlled

Background: Reviews have consistently shown that allocation concealment is frequently implemented and reported suboptimally in randomised controlled trials (RCTs). This research aims to pilot engaging with authors of RCTs to explore their knowledge and understanding of allocation concealment implementation and reporting to ascertain areas and mechanisms for their improvement. Methods: Authors that published RCTs in core clinical journals in one month in 2019 were identified. Authors were invited to complete questionnaires to elicit their views and experiences on the implementation and reporting quality focussing on allocation concealment. Methodological quality of allocation concealment was evaluated in this sample by assessing adherence to the Consolidated Standards of Reporting Trials (CONSORT). Results: Reporting was suboptimal, with only 57% of allocation concealment methods reported to be implemented which were judged as adequate, with 18% using sealed envelopes and more than 40% not adequately reporting allocation methods. When exploring allocation concealment, implementation and reporting questionnaires were found to elicit a low response rate amongst authors of RCTs. Discussion: Following analysis of the themes that emerged from the questionnaires, the main recommendations to improve reporting quality are: journals need to endorse, adhere and promote reporting guidelines, a methodologist could review methodological details of publications simultaneously to peer review, envelopes as a form of allocation concealment are poorly implemented and reported, so careful review of these is required, funders need to insist on more robust allocation concealment methods are employed if the RCT setting allows, and authors need to acknowledge their responsibility for transparent reporting of RCTs.

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