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

Gagnier, Joel; Boon, H; Rochon, Paula A.; Moher, D; Barnes, Joanne; Bombardier, Claire

doi:10.2165/00002018-200629100-00096

Cited by 12 publications

(13 citation statements)

References 2 publications

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“…Evaluations of RCTs since implementation of the CONSORT statement suggest that the statement has improved the quality of reporting of RCTs (Moher et al, 2001a;Plint et al, 2006;Kane et al, 2007). Extensions of the CONSORT statement have been developed for cluster trials (Campbell et al, 2004a(Campbell et al, , 2005, harms (Ioannidis et al, 2004), herbals interventions (Gagnier et al, 2005(Gagnier et al, , 2006a, non-pharmacological interventions (Boutron et al, 2008) and abstracts (Hopewell et al, 2008).…”

Section: Incomplete and Inaccurate Reporting In Published Livestock Imentioning

confidence: 99%

The REFLECT Statement: Reporting Guidelines for Randomized Controlled Trials in Livestock and Food Safety: Explanation and Elaboration

Sargeant

O’Connor

Gardner

et al. 2010

Journal of Food Protection

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Concerns about the completeness and accuracy of reporting of randomized clinical trials (RCTs) and the impact of poor reporting on decision making have been documented in the medical field over the past several decades. Experience from RCTs in human medicine would suggest that failure to report critical trial features can be associated with biased estimated effect measures, and there is evidence to suggest that similar biases occur in RCTs conducted in livestock populations. In response to these concerns, standardized guidelines for reporting RCTs were developed and implemented in human medicine. The Consolidated Standards of Reporting Trials (CONSORT) statement was first published in 1996, with a revised edition published in 2001. The CONSORT statement consists of a 22-item checklist for reporting a RCT and a flow diagram to follow the number of participants at each stage of a trial. An explanation and elaboration document not only defines and discusses the importance of each of the items, but also provides examples of how this information could be supplied in a publication. Differences between human and livestock populations necessitate modifications to the CONSORT statement to maximize its usefulness for RCTs involving livestock. These have been addressed in an extension of the CONSORT statement titled the REFLECT statement: Methods and processes of creating reporting guidelines for randomized control trials for livestock and food safety. The modifications made for livestock trials specifically addressed the common use of group housing and group allocation to intervention in livestock studies; the use of deliberate challenge models in some trials and the common use of non-clinical outcomes, such as contamination with a foodborne pathogen. In addition, the REFLECT statement for RCTs in livestock populations proposed specific terms or further clarified terms as they pertained to livestock studies. KeywordsRandomized trials, livestock, challenge studies and standards RightsWorks produced by employees of the U.S. Government as part of their official duties are not copyrighted within the U.S. The content of this document is not copyrighted. AbstractConcerns about the completeness and accuracy of reporting of randomized clinical trials (RCTs) and the impact of poor reporting on decision making have been documented in the medical field over the past several decades. Experience from RCTs in human medicine would suggest that failure to report critical trial features can be associated with biased estimated effect measures, and there is evidence to suggest that similar biases occur in RCTs conducted in livestock populations. In response to these concerns, standardized guidelines for reporting RCTs were developed and implemented in human medicine. The Consolidated Standards of Reporting Trials (CONSORT) statement was first published in 1996, with a revised edition published in 2001. The CONSORT statement consists of a 22-item checklist for reporting a RCT and a flow diagram to follow the number of participants...

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Section: Incomplete and Inaccurate Reporting In Published Livestock Imentioning

confidence: 99%

The REFLECT Statement: Reporting Guidelines for Randomized Controlled Trials in Livestock and Food Safety: Explanation and Elaboration

Sargeant

O’Connor

Gardner

et al. 2010

Journal of Food Protection

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show abstract

“…Further, many international academic societies recommend compliance with the CONSORT statement for RCTs. [4][5][6] One limitation of the CONSORT statement, however, is that it is not a tool to assess the quality of an RCT, simply a set of guidelines for its preparation.…”

mentioning

confidence: 99%

Randomized Controlled Trials In Endourology: A Quality Assessment

Autorino

Chung

et al. 2013

Journal of Endourology

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Purpose: To analyze the quality of studies reporting randomized clinical trials (RCTs) in the field of endourology. Materials and Methods: RCTs published in the Journal of Endourology from 1993 until 2011 were identified. The Jadad scale, van Tulder scale, and Cochrane Collaboration Risk of Bias Tool (CCRBT) were used to assess the quality of the studies. The review period was divided into early (1993-1999), mid (2000-2005), and late (2006)(2007)(2008)(2009)(2010)(2011) terms. Studies were categorized by country of origin, subject matter, single-vs multicenter setting, Institutional Review Board (IRB) approval and funding support, and blinding vs nonblinding. Results: In total, 3339 articles had been published during the defined review period, of which 165 articles were reporting a RCT. There was a significant increase in the number of RCTs published over time, with 18 (2.81%), 43 (4.88%), and 104 (5.72%) studies identified in the early, mid, and late term, respectively (P = 0.009). Nevertheless, there was no difference in terms of quality of reporting, as assessed with the Jadad scale, van Tulder scale, or CCRBT, between the three study terms. On the other hand, significant differences were found in both the number of high qualitative RCTs that used blinding methodology and those that had IRB review, when comparing the early, mid, and late terms. Conclusion: There has been a growing number of Journal of Endourology publications reporting on RTC over the last two decades. The quality of reporting for these studies remains suboptimal, however. Researchers should focus on a more appropriate description of key features of any given RCT, such as randomization and allocation methods, as well as disclosure of IRB review and financial support.

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“…e heterogeneity was not reduced significantly after subgroup analyses such as TCM syndrome, which may be mainly due to poor reporting quality and lack of clinical homogeneity. Most trials did not comply with Consolidated Standards of Reporting Trials (CONSORT) statement and the Herbal Interventions promotion to conduct standard clinical studies [54,55]. Additionally, the clinical practice of TCM is characterized by syndrome differentiation and treatment, which leads to various drug ingredients, dosages, and administration frequency of herbal paste.…”

Section: Evidence-based Complementary and Alternative Medicinementioning

confidence: 99%

The Effects and Safety of Chinese Oral Herbal Paste on Stable Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta‐analysis of Randomized Controlled Trials

Zeng

Hua

et al. 2020

Evidence-Based Complementary and Alternative Medicine

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Background. Chinese oral herbal paste has been widely used in the treatment of chronic obstructive pulmonary disease (COPD). However, the treatment effects of herbal paste were controversial and lack evidence to support its clinical use. This study aims to systematically assess the efficacy and safety of Chinese oral herbal paste for the treatment of stable COPD. Methods. PubMed, Web of Science, CENTRAL, EMBASE, CNKI, VIP, CBM, and WANFANG database in addition to two websites of clinical trial registry were searched from respective inception to August 2019. Only randomized controlled trials (RCTs) studying Chinese herbal paste for the treatment of stable COPD were included. Methodological quality was assessed based on Cochrane risk of bias and GRADE approach. Data were analyzed using RevMan 5.3. Results. A total of 19 RCTs with 1303 individuals compared Chinese oral herbal paste and Western medicine (WM) with WM alone were included for meta-analysis. The review showed compared with WM alone, the combination of herbal paste and WM reduced exacerbation frequency. Subgroup analyses showed that after two to three months of treatment, compared with WM alone, Chinese herbal paste plus WM significantly decreased the St George’s Respiratory Questionnaire (SGRQ) scores, COPD assessment test (CAT) scores, and scores of traditional Chinese medicine (TCM) syndrome, and improved clinical effective rates, lung function, and 6-minute walk distance. No serious adverse events related to herbal paste were reported. Conclusion. Current evidence showed that Chinese oral herbal paste may be an effective and well-tolerated adjuvant therapy for stable COPD. Considering the risks of bias and heterogeneity, more high-quality, well-designed RCTs are still needed.

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

Cited by 12 publications

References 2 publications

The REFLECT Statement: Reporting Guidelines for Randomized Controlled Trials in Livestock and Food Safety: Explanation and Elaboration

The REFLECT Statement: Reporting Guidelines for Randomized Controlled Trials in Livestock and Food Safety: Explanation and Elaboration

Randomized Controlled Trials In Endourology: A Quality Assessment

The Effects and Safety of Chinese Oral Herbal Paste on Stable Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta‐analysis of Randomized Controlled Trials

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