Quality of Reports on Randomized Controlled Trials Conducted in Japan: Evaluation of Adherence to the CONSORT Statement

Uetani, Kae; Nakayama, Takeo; Itoh, Hiroshi; Yonemoto, Naohiro; Moher, David

doi:10.2169/internalmedicine.48.1358

Cited by 51 publications

(44 citation statements)

References 27 publications

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“…Unfortunately, the authors found that only 9% of the trial reports the authors reviewed provided a description of allocation concealment or randomization in the title or abstract. This result is even poorer than that observed in previous studies [23,33,34]. This leads a reader to question whether the randomization process was free from human alteration and, in turn, whether the findings were valid.…”

Section: Exploratory Analysis: Factors Associated With Better Reportimentioning

confidence: 57%

Quality of reporting and its correlates among randomized controlled trials on acupuncture for cancer pain: application of the CONSORT 2010 Statement and STRICTA

Lu¹,

Liao²,

Zeng³

et al. 2013

Expert Review of Anticancer Therapy

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This study aims to analyze the quality of reporting and its correlates in randomized controlled trials (RCTs) on acupuncture for cancer pain. Quality of reporting for included papers was assessed against a subset of criteria adapted from the CONSORT 2010 statement and STRICTA. An overall quality score (OQS) and a combined key methodologic index score (MIS) was calculated for each trial. Factors associated with OQS and MIS were then identified. A total of 32 RCTs were included in the full text. The median OQS based on the CONSORT Statement and STRICTA was 4.0 and 0, respectively. The significant predictors for CONSORT OQS were year of publication and nationality of authors, for STRICTA it was nationality of authors and for MIS it was publication language. The quality of reporting in RCTs on acupuncture for cancer pain was poor. This indicates that RCTs on acupuncture for cancer pain need substantial improvement.

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Section: Exploratory Analysis: Factors Associated With Better Reportimentioning

confidence: 57%

Quality of reporting and its correlates among randomized controlled trials on acupuncture for cancer pain: application of the CONSORT 2010 Statement and STRICTA

Lu¹,

Liao²,

Zeng³

et al. 2013

Expert Review of Anticancer Therapy

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“…6,23,32,43 On a larger scale, the Japanese medical community reviewed their country's publications on RCTs and revealed a "significant need for improvement." 46 The CONSORT guidelines were designed to aid potential investigators in every aspect of trial design and execution. Unfortunately, because the guidelines are typically referred to in the "Instructions to Authors" section of journal websites, 22 many authors do not become aware of the guidelines until the time of manuscript submission, which is often too late.…”

Section: Resultsmentioning

confidence: 99%

Standards for reporting randomized controlled trials in neurosurgery

Kiehna¹,

Starke²,

Pouratian³

et al. 2011

JNS

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Object. The Consolidated Standards for Reporting of Trials (CONSORT) criteria were published in 1996 to standardize the reporting and improve the quality of clinical trials. Despite having been endorsed by major medical journals and shown to improve the quality of reported trials, neurosurgical journals have yet to formally adopt these reporting criteria. The purpose of this study is to evaluate the quality and reporting of randomized controlled trials (RCTs) in neurosurgery and the factors that may affect the quality of reported trials.Methods. The authors evaluated all neurosurgical RCTs published in 2006 and 2007 in the principal neurosurgical journals (Journal of Neurosurgery; Neurosurgery; Surgical Neurology; Journal of Neurology, Neurosurgery, and Psychiatry; and Acta Neurochirurgica) and in 3 leading general medical journals (Journal of the American Medical Association, Lancet, and the New England Journal of Medicine). Randomized controlled trials that addressed operative decision making or the treatment of neurosurgical patients were included in this analysis. The RCT quality was evaluated using the Jadad score and the CONSORT checklist.Results. In 2006 and 2007, 27 RCTs relevant to intracranial neurosurgery were reported. Of these trials, only 59% had a Jadad score ≥ 3. The 3 major medical journals all endorsed the CONSORT guidelines, while none of the neurosurgical journals have adopted these guidelines. Randomized controlled trials published in the 3 major medical journals had a significantly higher mean CONSORT score (mean 41, range 39-44) compared with those published in neurosurgical journals (mean 26.4, range 17-38; p < 0.0001). Jadad scores were also significantly higher for the major medical journals (mean 3.42, range 2-5) than neurosurgical journals (mean 2.45, range 1-5; p = 0.05).Conclusions. Despite the growing volume of RCTs in neurosurgery, the quality of reporting of these trials remains suboptimal, especially in the neurosurgical journals. Improved awareness of the CONSORT guidelines by journal editors, reviewers, and authors of these papers could improve the methodology and reporting of RCTs in neurosurgery.

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“…74 Similarly, only 11% of Japanese RCTs published in MEDLINE between January and March 2004 followed the guidelines described in the CONSORT statement. 75 Low quality in the reporting of trials from Asia has a direct impact on the validity of conclusions in systematic reviews, which are often used as the source of information for developing health-care policies and guidelines. In an overview of Cochrane systematic reviews of traditional Chinese herbal products for coronary heart diseases, none of the included systematic reviews provided definitive conclusions owing to the very low methodological quality of the included RCTs, most of which were conducted in China.…”

Section: Varied Quality In Trial Reportingmentioning

confidence: 99%

The need for multicentre cardiovascular clinical trials in Asia

Kwong

2013

Nat Rev Cardiol

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Historically, the USA and European countries have been the dominant figures in medical research. However, in the past 10 years, Asia has emerged as a new 'hot spot' for clinical research owing to the tremendous potential generated by steady economic growth, remarkable advances in research and development capacity, and an expanding population. However, investigators involved with the set-up and conduct of multicentre trials in such a vast and heterogeneous continent face huge challenges-bridging the fundamental differences between the Asian countries, such as languages, resources, regulatory procedural timelines, and the general understanding of clinical research. In this Perspectives article, we explain why Asia should be established as a hub for large multicentre trials, discuss the challenges involved, and highlight the importance of a strong collaborative infrastructure for multiple investigational sites in this culturally diverse continent.

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Quality of Reports on Randomized Controlled Trials Conducted in Japan: Evaluation of Adherence to the CONSORT Statement

Cited by 51 publications

References 27 publications

Quality of reporting and its correlates among randomized controlled trials on acupuncture for cancer pain: application of the CONSORT 2010 Statement and STRICTA

Quality of reporting and its correlates among randomized controlled trials on acupuncture for cancer pain: application of the CONSORT 2010 Statement and STRICTA

Standards for reporting randomized controlled trials in neurosurgery

The need for multicentre cardiovascular clinical trials in Asia

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