Improving the Quality of Reporting of Randomised Controlled Trials Evaluating Herbal Interventions: Implementing the CONSORT Statement

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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Evaluation of Reporting Quality in Randomised Controlled Trials of Acupuncture for Acute Herpes Zoster by the CONSORT Statement and STRICTA Guidelines

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/4308380 ◽

2020 ◽

Vol 2020 ◽

pp. 1-7

Author(s):

Guifeng Qian ◽

Jingchun Zeng ◽

Liming Lu ◽

Wenya Pei ◽

Kun Liu ◽

...

Keyword(s):

Herpes Zoster ◽

Randomised Controlled Trials ◽

Reporting Quality ◽

Consort Statement ◽

Controlled Trials ◽

Kappa Statistics ◽

Acute Herpes Zoster ◽

The Consort Statement ◽

Randomised Controlled

Objective. To explore the methods for improving the reporting quality of randomised controlled trials (RCTs) on acupuncture through evaluating the reporting quality in RCTs of acupuncture for acute herpes zoster by the CONSORT statement and STRICTA guidelines. Methods. English and Chinese databases were searched from database creation until October 2018 and updated to July 2019. The basic characteristics and methodological quality of the literatures included were evaluated based on the CONSORT statement and the STRICTA guidelines. Descriptive statistical analysis was used in this study. The agreement between the two researchers of all items was calculated by Cohen’s kappa statistics. Results. A total of 40 RCTs were included. Based on the CONSORT statement, items “Background,” “Randomised” in the title or abstract,” “Statistical methods,” and “Outcomes and estimation” were good reporting, with positive rates >80%. However, the quality of reporting in items “Sample size,” “Allocation concealment,” “Implementation,” “Blinding,” “Flow chart,” “Intent-to-treat analysis,” “Ancillary analyses,” and “Clinical Trials Register” was very poor, with positive rates <10%. Based on the STRICTA guidelines, good reporting existed in items “Acupuncture rational,” “Points used,” “Needle stimulation,” “Needle retention time,” “Course of treatment,” “Control intervention,” and “Treatment frequency,” with positive ratings >80%. The reporting quality of items “Numbers of needles inserted,” “Depth of insertion,” “Responses elicited,” and “Practitioner background” was lower, with positive rates <50%. The agreement of most items was judged as moderate, substantial, or good.Conclusion. The reporting quality of RCTs in acupuncture for acute HZ is generally inadequate. It is necessary that researchers and journal editors learn and raise the adoption of the CONSORT statement and STRICTA guidelines to enhance the reporting quality of the RCTs in acupuncture.

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Improved quality of reporting safety data of medication in paediatric randomised controlled trials

Archives of Disease in Childhood ◽

10.1136/archdischild-2020-321197 ◽

2021 ◽

pp. archdischild-2020-321197

Author(s):

Taco Jan Prins ◽

Corine Rollema ◽

Eric van Roon ◽

Tjalling de Vries

Keyword(s):

Adverse Events ◽

Randomised Controlled Trials ◽

Safety Data ◽

Drug Event ◽

Controlled Trials ◽

Quality Of Reporting ◽

Event Reporting ◽

The Past ◽

Randomised Controlled

ObjectiveEvaluating the reporting of safety data of medication in paediatric randomised controlled trials (RCTs) in 2017–2018 compared with our earlier study.DesignLiterature search with a systemic appraisal of adverse drug event reporting.Main outcome measuresQuality of reporting of safety data using Consolidated Standards of Reporting Trials (CONSORT) and Ioannidis scores in paediatric drug RCTs. The CONSORT score consists of nine recommendations of the CONSORT Group issued to improve the quality of reporting adverse events. The Ioannidis score is based on these advices. We considered a CONSORT score of at least 6 and an Ioannidis score of at least 3 as sufficient.ResultsWe reviewed 100 RCTs published in 2017 and 2018. Ninety-four (94%) articles mentioned adverse events compared with 78% in the earlier study. Fifty-seven per cent used a standardised method for reporting adverse events compared with 34% in our earlier study. In 26 of the articles, the expected adverse events were defined, and 27 articles had a preset standardised scale for adverse events. Of these, 62 articles (62%) had a CONSORT score of 6 or higher compared with 18% in 2010. In the present study, 67% had an Ioannidis score of 3 or higher, whereas in the earlier study this was 29%. Both differences are statistically significant (p<0.05).ConclusionsReporting safety data in paediatric RCTs has improved over the past 10 years. However, there is still room for improvement and for further improvement. Authors and editors should give more attention to methods for collecting, reporting and presenting safety data of RCTs in studies and manuscripts.

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