Quality of Reporting of Randomized Clinical Trials in Tai Chi Interventions—A Systematic Review

Objectives. To evaluate the reporting quality of published randomized clinical trials (RCTs) in the Tai Chi literature following the publication of the CONSORT guidelines in 2001.Data Sources. The OVID MEDLINE and PUBMED databases.Review Methods. To survey the general characteristics of Tai Chi RCTs in the literature, we included any report if (i) it was an original report of the trial; (ii) its design was RCT; (iii) one of the treatments being tested was Tai Chi; and (iv) it was in English. In addition, we assessed the reporting quality of RCTs that were published between 2002 and 2007, using a modified CONSORT checklist of 40 items. The adequate description of Tai Chi interventions in these trials was examined against a 10-item checklist adapted from previous reviews.Results. The search yielded 31 Tai Chi RCTs published from 2002 to 2007 and only 11 for 1992–2001. Among trials published during 2002–2007, the most adequately reported criteria were related to background, participant eligibility and interpretation of the study results. Nonetheless, the most poorly reported items were associated with randomization allocation concealment, implementation of randomization and the definitions of period of recruitment and follow-up. In addition, only 23% of RCTs provided adequate details of Tai Chi intervention used in the trials.Conclusion. The findings in this review indicated that the reporting quality of Tai Chi intervention trials is sub-optimal. Substantial improvement is required to meet the CONSORT guidelines and allow assessment of the quality of evidence. We believe that not only investigators, but also journal editors, reviewers and funding agencies need to follow the CONSORT guidelines to improve the standards of research and strengthen the evidence base for Tai Chi and for complementary and alternative medicine.

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Randomized Clinical Trials Presented at the World Congress of Endourology: How Is the Quality of Reporting?

Journal of Endourology ◽

10.1089/end.2009.0541 ◽

2010 ◽

Vol 24 (12) ◽

pp. 2067-2073 ◽

Cited By ~ 11

Author(s):

Riccardo Autorino ◽

Claudio Borges ◽

Michael A. White ◽

Fatih Altunrende ◽

Sisto Perdoná ◽

...

Keyword(s):

Clinical Trials ◽

Randomized Clinical Trials ◽

World Congress ◽

Quality Of Reporting ◽

The World

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Abstract No. 236: Quality of reporting of randomized clinical trials in the Journal of Vascular and Interventional Radiology

Journal of Vascular and Interventional Radiology ◽

10.1016/j.jvir.2009.12.021 ◽

2010 ◽

Vol 21 (2) ◽

pp. S90-S91

Author(s):

J.T. Cardella ◽

J. Spies

Keyword(s):

Clinical Trials ◽

Interventional Radiology ◽

Randomized Clinical Trials ◽

Quality Of Reporting

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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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Abstract reporting in randomized clinical trials of acute lung injury: An audit and assessment of a quality of reporting score*

Critical Care Medicine ◽

10.1097/01.ccm.0000178361.73895.24 ◽

2005 ◽

Vol 33 (9) ◽

pp. 1937-1945 ◽

Cited By ~ 22

Author(s):

Karen E. A. Burns ◽

Neill K. J. Adhikari ◽

Michelle Kho ◽

Maureen O. Meade ◽

Rakesh V. Patel ◽

...

Keyword(s):

Clinical Trials ◽

Acute Lung Injury ◽

Lung Injury ◽

Randomized Clinical Trials ◽

Quality Of Reporting ◽

Abstract Reporting

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Does quality of treatment-related harms reporting affect conclusions about superiority of treatment?

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.6607 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. 6607-6607

Author(s):

R. S. Mhaskar ◽

A. Kumar ◽

H. Soares ◽

M. Schell ◽

B. Djulbegovic

Keyword(s):

Randomized Clinical Trials ◽

Standard Treatment ◽

Reporting Quality ◽

Phase Iii ◽

Quality Of Reporting ◽

Chi Square ◽

Outcome Reporting Bias ◽

Quality Of Treatment ◽

Experimental Treatments

6607 Background: It is often not known if harms were considered in the overall benefit-risk evaluation in deciding about the superiority of treatments. Here we present a study examining the relationship between researchers’ conclusions about the superiority of treatment with quality of treatment-related harms reporting. Methods: We reviewed all consecutive phase III randomized clinical trials (RCTs) conducted by Southwest Oncology Group from 1960 to 2003 (117 RCTs involving 139 comparisons enrolling 58,908 patients). We extracted data on primary outcomes [overall survival (OS), event free survival (EFS)], and treatment-related mortality (TRM). We classified the quality of reporting as good, intermediate or poor. Association of superiority of treatment and harms reporting was evaluated using chi-square test and meta-analytic techniques. Results: 76% of studies (106/139) reported TRM. Of these, the quality of reporting of harms was considered as “good” in 36% (38/106) of studies, “intermediate” in 55% (58/106), and “poor” in 9% (10/106). Investigators judged experimental treatments to be superior in 34% of trials (48/139) while standard treatment was superior in 66% (91/139). TRM data was reported in 75% (36/48) of results favoring experimental treatments and 78% (70/91) of results favoring standard treatments. There was no association between superiority of a treatment and TRM reporting (p = 0.80) or quality of harms reporting (p = 0.83). The pooled hazard ratio (HR) for OS in RCTs reporting TRM was 0.94 (95% CI: 0.90, 0.99) and for RCTs not reporting TRM was 0.99 (95% CI: 0.89, 1.09) (test of heterogeneity p = 0.06). The pooled HR for EFS among RCTs reporting TRM was 0.88 (95% CI: 0.83, 0.94) and for RCTs not reporting TRM it was 1.01 (95% CI: 0.79, 1.29) (test of heterogeneity p = 0.07). Additionally, the pooled HR for OS and EFS did not show any bias in reporting of harms according to harms reporting quality. Conclusions: Investigators’ conclusion regarding the superiority of experimental or standard treatment does not appear to be associated with outcome reporting bias for harms. Investigators judge both harms and benefits when they draw conclusions about treatment superiority. No significant financial relationships to disclose.

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Deficiencies in the reporting quality of RCTs in neurosurgery: How can we do better?

Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques ◽

10.1017/cjn.2015.80 ◽

2015 ◽

Vol 42 (S1) ◽

pp. S12-S12

Author(s):

A Mansouri ◽

B Cooper ◽

S Shin ◽

D Kondziolka

Keyword(s):

Sample Size Calculation ◽

Reporting Quality ◽

Allocation Concealment ◽

High Yield ◽

Quality Of Reporting ◽

Randomized Controlled ◽

Study Designs ◽

Design Factors

Background: Deficiencies in design and reporting of randomized controlled trials (RCTs) limit their validity. The quality of recent RCTs in neurosurgery was analyzed to assess adequacy of design and reporting. Methods: A high-yield search of the MEDLINE and EMBASE databases (2000-present) was conducted. The CONSORT and Jadad scales were used to assess the quality of design/reporting. A PRECIS-based scale was used to designate studies on the pragmatic-explanatory continuum. Spearman’s test was used to assess correlations. Regression analysis was used to assess associations. Results: Sixty-one articles were identified. Vascular was the most common sub-specialty (37%). The median CONSORT and Jadad scores were 36 (IQR 27.5-39) and 3 (IQR 2-3). Blinding, sample size calculation and allocation concealment were most deficiently reported. The quality of reporting did not correlate with the study impact. The majority of studies (83%) had pragmatic objectives; while pragmatic studies had compatible design factors, trials with explanatory objectives were less successful. Conclusions: The prevalence and quality of neurosurgical RCTs is low. Many study designs are not compatible with stated objectives. Given the role of RCTs as one of the highest levels of evidence, it is critical to improve on their methodology and reporting. Alternative methodologies merit discussion.

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Assessment of quality of reporting of Helicobacter pylori related randomized controlled trials: a focus on highly ranked gastroenterology journals

International Journal of Clinical Trials ◽

10.18203/2349-3259.ijct20180127 ◽

2018 ◽

Vol 5 (1) ◽

pp. 21

Author(s):

Mahmood E. Elrggal ◽

Morooj Al-Muwallad ◽

Areej Al-Otaibi ◽

Jomanah Alsiddik ◽

Alaa Shahbar ◽

...

Keyword(s):

Clinical Trials ◽

Helicobacter Pylori ◽

Randomized Controlled Trials ◽

Consort Statement ◽

Allocation Concealment ◽

Controlled Trials ◽

Quality Of Reporting ◽

Randomized Controlled ◽

Randomised Controlled

Background: Randomized controlled trials are often considered as the gold standard for measuring the effectiveness of an intervention. However, inappropriate or poor reporting in randomized controlled trials can produce biased estimates of treatment effects. Clinical trials that do not use the CONSORT statement for reporting their findings will have limited value to the clinicians and researchers due to the risk of bias in their results. This review aims to assess the quality of reporting of randomized controlled trials in Helicobacter pylori associated infections by using the CONSORT 2010 checklist.Methods: All issues of 20 highly ranked gastroenterology journals published from Jan 2011 up to November 2017 were searched. Searches were conducted in November 2017. Randomized controlled trials reporting on Helicobacter pylori associated infections were included in the review.Results: 21 randomized controlled trials published in gastroenterology journals were included in the study. All included studies adequately reported (100%) on items including description of interventions, outcomes assessed, total number of participants analysed, baseline characteristics and results of outcome assessed. However, items including blinding and mechanism of allocation concealment were reported in only 12 randomized controlled trials (50%). The maximum and minimum scores and percentage of compliance of included randomised controlled trials were 24 (100%) and 15 (62.5%) respectively.Conclusions: The finding of this review suggests that the overall quality of reporting in the included randomized controlled trials was adequate. However, items including trial design, trial registration and protocol and sample size calculations should be reported adequately in the future randomized controlled trials to improve the quality of reporting and replicability of clinical trials.

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