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

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

Acupuncture in Medicine ◽

10.1136/acupmed-2016-011062 ◽

2017 ◽

Vol 35 (2) ◽

pp. 100-106 ◽

Cited By ~ 10

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.

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Association between bibliometric parameters, reporting and methodological quality of randomised controlled trials in vascular and endovascular surgery

Vascular ◽

10.1177/1708538116653289 ◽

2016 ◽

Vol 25 (2) ◽

pp. 196-207 ◽

Cited By ~ 1

Author(s):

Shahab Hajibandeh ◽

Shahin Hajibandeh ◽

George A Antoniou ◽

Patrick A Green ◽

Michelle Maden ◽

...

Keyword(s):

Study Design ◽

Methodological Quality ◽

Randomised Controlled Trials ◽

Linear Regression Analysis ◽

Reporting Quality ◽

Consort Statement ◽

Endovascular Surgery ◽

Controlled Trials ◽

Randomised Controlled

Purpose We aimed to investigate association between bibliometric parameters, reporting and methodological quality of vascular and endovascular surgery randomised controlled trials. Methods The most recent 75 and oldest 75 randomised controlled trials published in leading journals over a 10-year period were identified. The reporting quality was analysed using the CONSORT statement, and methodological quality with the Intercollegiate Guidelines Network checklist. We used exploratory univariate and multivariable linear regression analysis to investigate associations. Findings Bibliometric parameters such as type of journal, study design reported in title, number of pages; external funding, industry sponsoring and number of citations are associated with reporting quality. Moreover, parameters such as type of journal, subject area and study design reported in title are associated with methodological quality. Conclusions The bibliometric parameters of randomised controlled trials may be independent predictors for their reporting and methodological quality. Moreover, the reporting quality of randomised controlled trials is associated with their methodological quality and vice versa.

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A Cross-sectional literature survey showed the reporting quality of multicentre randomised controlled trials should be improved

Journal of Clinical Epidemiology ◽

10.1016/j.jclinepi.2021.05.008 ◽

2021 ◽

Author(s):

Xuan Zhang ◽

Wai Ching Lam ◽

Fan Liu ◽

Mengdan Li ◽

Lin Zhang ◽

...

Keyword(s):

Randomised Controlled Trials ◽

Reporting Quality ◽

Literature Survey ◽

Controlled Trials ◽

Cross Sectional ◽

Randomised Controlled

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A systematic review of randomised controlled trials of psychosocial interventions for acute mental health inpatients

British Journal of Mental Health Nursing ◽

10.12968/bjmh.2018.0023 ◽

2021 ◽

Vol 10 (3) ◽

pp. 1-17

Author(s):

Laura D Wainwright ◽

Gillian Haddock ◽

Charlotte Dunster-Page ◽

Katherine Berry

Keyword(s):

Quality Of Life ◽

Methodological Quality ◽

Randomised Controlled Trials ◽

Social Care ◽

Psychosocial Interventions ◽

Controlled Trials ◽

Patient Functioning ◽

Electronic Search ◽

Randomised Controlled

Background/Aims Inpatient wards provide an opportunity to intervene with medical, psychological and social care to contain distress and prevent future relapse. However, they have been criticised for an over-reliance on medication and risk management with limited psychosocial interventions. The aim of this study was to investigate clinical trials of psychosocial interventions for inpatients to identify interventions that are effective at improving quality of life, symptoms or patient functioning. Methods An electronic search of six databases was conducted for papers published from 1806 up until February 2017. A total of 18 randomised controlled trials was identified in which outcomes for symptoms, quality of life or functioning were reported. Results Overall, 15 trials showed a statistically significant result for at least one outcome. Seven categories were identified from the 18 studies, at least one in each category was found to be effective for symptoms, quality of life or functioning. The majority were effective (15 out of 18). Conclusions Given that the methodological quality was generally low and number of randomised controlled trials were small, it is difficult to draw definitive conclusions. Recommendations include more and repeated trials using rigorous methods of testing and reporting.

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Acupuncture for Amnestic Mild Cognitive Impairment: A Meta-Analysis of Randomised Controlled Trials

Acupuncture in Medicine ◽

10.1136/acupmed-2015-010989 ◽

2016 ◽

Vol 34 (5) ◽

pp. 342-348 ◽

Cited By ~ 23

Author(s):

Min Deng ◽

Xu-Feng Wang

Keyword(s):

Cognitive Impairment ◽

Mild Cognitive Impairment ◽

Methodological Quality ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Scientific Journal ◽

Adjunctive Treatment ◽

Controlled Trials ◽

Randomised Controlled

Objective Mild cognitive impairment (MCI) is a pre-dementia state; 5–10% of cases per year will evolve into dementia. MCI can be amnestic (AMCI) or non-amnestic. AMCI is associated with a higher risk of progression. In recent years, interest in acupuncture as a potential treatment for AMCI has grown. The aim of this meta-analysis was to estimate the clinical effectiveness and safety of acupuncture for AMCI. Methods Randomised controlled trials (RCTs) of acupuncture versus medical treatment for AMCI were identified using the following databases from inception to July 2015: PubMed; Medline; CENTRAL; Chinese Scientific Journal Database; The Chinese Acupuncture Trials Register; China National Knowledge Infrastructure (CNKI); and Wanfang database. Data were extracted from RCTs meeting the inclusive criteria according to Cochrane methods. Meta-analyses were conducted using Rev Man V.5.3 software. Results Five trials involving 568 subjects were included. Meta-analysis showed that participants receiving acupuncture had better outcomes than those receiving nimodipine with greater clinical efficacy rates (odds ratio (OR) 1.78, 95% CI 1.19 to 2.65; p<0.01), mini-mental state examination (MMSE) scores (mean difference (MD) 0.99, 95% CI 0.71 to 1.28; p<0.01), and picture recognition score (MD 2.12, 95% CI 1.48 to 2.75; p<0.01). Meta-analysis also showed acupuncture in conjunction with nimodipine significantly improved MMSE scores (MD 1.09, 95% CI 0.29 to 1.89; p<0.01) compared to nimodipine alone. Three trials reported adverse events. Methodological quality of the included studies was judged to be generally poor. Conclusions Acupuncture appears effective for AMCI when used as an alternative or adjunctive treatment; however, caution must be exercised given the low methodological quality of included trials. Further, more rigorously designed studies are needed.

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