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Reporting of Protocol Rationale and Content Validity in Randomized Clinical Trials of T'ai Chi: A Systematic Evaluation.

ABSTRACT: BACKGROUND:Mind-body exercise interventions are typically multimodal, complex, and pluralistic, and few have been developed with the goal of therapeutically targeting a specific medical population. It is thus important that clinical trials evaluating mind-body interventions provide some justification for the use of the specific protocol being evaluated. OBJECTIVES:This article reports the results of a systematic review of the quality of reporting of protocol rationale and content validity for using a specific t'ai chi protocol in a randomized controlled trial (RCT). METHODS:Electronic literature searches were conducted using PubMed/MEDLINE, EBSCOhost, and the Cochrane Library from inception through June 2015. Search terms were Tai Chi, Taiji, Tai Chi Chuan; searches were limited to English-language RCTs. Inclusion and exclusion of trials were reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The authors assessed the level of reporting with respect to t'ai chi protocol validation using a 5-point grading system based on whether (1) a specific protocol was mentioned, (2) rationale for the specific protocol was stated and supported, and (3) formal evaluation for content validity was conducted. RESULTS:There was significant heterogeneity in the quality of reporting related to protocol rationale and content validity. A total of 171 publications were identified. Studies met between 0 and 4 validity criteria (of possible 5, more indicating better quality), with a mean of 2.52 (±SD 1.2) and median of 3. Twenty (12%) trials did not mention a specific t'ai chi protocol, 10 (6%) trials met 0 of 5 criteria, and 47 (31%) studies met 4 of 5 criteria. Formal validity assessments were employed in only one trial. CONCLUSIONS:The poor quality of protocol rationale and content validity reporting limits our ability to accurately evaluate the evidence of t'ai chi as a therapeutic intervention. The development of formal guidelines for developing and reporting intervention validity for multimodal mind-body exercises like t'ai chi may improve the quality and interpretability of research.

SUBMITTER: Litrownik D

PROVIDER: S-EPMC6909733 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Reporting of Protocol Rationale and Content Validity in Randomized Clinical Trials of T'ai Chi: A Systematic Evaluation.

Litrownik Daniel D Gilliam Elizabeth E Berkowitz Danielle D Yeh Gloria Y GY Wayne Peter M PM

Journal of alternative and complementary medicine (New York, N.Y.) 20190305 4

<h4>Background</h4>Mind-body exercise interventions are typically multimodal, complex, and pluralistic, and few have been developed with the goal of therapeutically targeting a specific medical population. It is thus important that clinical trials evaluating mind-body interventions provide some justification for the use of the specific protocol being evaluated.<h4>Objectives</h4>This article reports the results of a systematic review of the quality of reporting of protocol rationale and content ...[more]

PMID: 30835135

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Project description:BackgroundPatient-reported outcomes (PROs) are captured within cancer trials to help future patients and their clinicians make more informed treatment decisions. However, variability in standards of PRO trial design and reporting threaten the validity of these endpoints for application in clinical practice.MethodsWe systematically investigated a cohort of randomized controlled cancer trials that included a primary or secondary PRO. For each trial, an evaluation of protocol and reporting quality was undertaken using standard checklists. General patterns of reporting where also explored.ResultsProtocols (101 sourced, 44.3%) included a mean (SD) of 10 (4) of 33 (range = 2-19) PRO protocol checklist items. Recommended items frequently omitted included the rationale and objectives underpinning PRO collection and approaches to minimize/address missing PRO data. Of 160 trials with published results, 61 (38.1%, 95% confidence interval = 30.6% to 45.7%) failed to include their PRO findings in any publication (mean 6.43-year follow-up); these trials included 49 568 participants. Although two-thirds of included trials published PRO findings, reporting standards were often inadequate according to international guidelines (mean [SD] inclusion of 3 [3] of 14 [range = 0-11]) CONSORT PRO Extension checklist items). More than one-half of trials publishing PRO results in a secondary publication (12 of 22, 54.5%) took 4 or more years to do so following trial closure, with eight (36.4%) taking 5-8 years and one trial publishing after 14 years.ConclusionsPRO protocol content is frequently inadequate, and nonreporting of PRO findings is widespread, meaning patient-important information may not be available to benefit patients, clinicians, and regulators. Even where PRO data are published, there is often considerable delay and reporting quality is suboptimal. This study presents key recommendations to enhance the likelihood of successful delivery of PROs in the future.

Project description:UNLABELLED: BACKGROUND: All randomized clinical trials (RCTs) require a protocol; however, numerous studies have highlighted protocol deficiencies. Reporting guidelines may improve the content of research reports and, if developed using robust methods, may increase the utility of reports to stakeholders. The objective of this study was to systematically identify and review RCT protocol guidelines, to assess their characteristics and methods of development, and to compare recommendations. METHODS: We conducted a systematic review of indexed literature (MEDLINE, EMBASE and the Cochrane Methodology Register from inception to September 2010; reference lists; related article features; forward citation searching) and a targeted search of supplementary sources, including a survey of major trial funding agencies in six countries. Records were eligible if they described a content guideline in English or French relevant to RCT protocols. Guidelines were excluded if they specified content for protocols for trials of specific procedures or conditions or were intended to assess trial quality. We extracted guideline characteristics and methods. Content was mapped for a subset of guidelines that described development methods or had institutional endorsement. RESULTS: Forty guidelines published in journals, books and institutional reports were included in the review; seven were specific to RCT protocols. Only eight (20%) described development methods which included informal consensus methods, pilot testing and formal validation; no guideline described all of these methods. No guideline described formal consensus methods or a systematic retrieval of empirical evidence to inform its development. The guidelines included a median of 23 concepts per guideline (interquartile range (IQR)?=?14 to 34; range?=?7 to 109). Among the subset of guidelines (n?=?23) for which content was mapped, approximately 380 concepts were explicitly addressed (median concepts per guideline IQR?=?31 (24,80); range?=?16 to 150); most concepts were addressed in a minority of guidelines. CONCLUSIONS: Existing guidelines for RCT protocol content varied substantially in their recommendations. Few reports described the methods of guideline development, limiting comparisons of guideline validity. Given the importance of protocols to diverse stakeholders, we believe a systematically developed, evidence-informed guideline for clinical trial protocols is needed.

Project description:BackgroundFatigue is not only a familiar symptom in our daily lives, but also a common ailment that affects all of our bodily systems. Several randomized controlled trials (RCTs) have proven Tai Chi to be beneficial for patients suffering from fatigue, however conclusive evidence is still lacking. A systematic review and meta-analysis was performed on all RCTs reporting the effects of Tai Chi for fatigue.MethodsIn the end of April 2016, seven electronic databases were searched for RCTs involving Tai Chi for fatigue. The search terms mainly included Tai Chi, Tai-ji, Taiji, fatigue, tiredness, weary, weak, and the search was conducted without language restrictions. Methodological quality was assessed using the Cochrane Risk of Bias tool. RevMan 5.3 software was used for meta-analysis. Publication bias was estimated with a funnel plot and Egger's test. We also assessed the quality of evidence with the GRADE system.ResultsTen trials (n = 689) were included, and there was a high risk of bias in the blinding. Two trials were determined to have had low methodological quality. Tai Chi was found to have improved fatigue more than conventional therapy (standardized mean difference (SMD): -0.45, 95% confidence interval (CI): -0.70, -0.20) overall, and have positive effects in cancer-related fatigue (SMD:-0.38, 95% CI: -0.65, -0.11). Tai Chi was also more effective on vitality (SMD: 0.63, 95% CI: 0.20, 1.07), sleep (SMD: -0.32, 95% CI: -0.61, -0.04) and depression (SMD: -0.58, 95% CI: -1.04, -0.11). However, no significant difference was found in multiple sclerosis-related fatigue (SMD: -0.77, 95% CI: -1.76, 0.22) and age-related fatigue (SMD: -0.77, 95% CI: -1.78, 0.24). No adverse events were reported among the included studies. The quality of evidence was moderate in the GRADE system.ConclusionsThe results suggest that Tai Chi could be an effective alternative and /or complementary approach to existing therapies for people with fatigue. However, the quality of the evidence was only moderate and may have the potential for bias. There is still absence of adverse events data to evaluate the safety of Tai Chi. Further multi-center RCTs with large sample sizes and high methodological quality, especially carefully blinded design, should be conducted in future research.Registration numberPROSPERO CRD42016033066.

Project description:Observational studies are based on systematic observation, understood as an organized recording and quantification of behavior in its natural context. Applied to the specific area of sports, observational studies present advantages when comparing studies based on other designs, such as the flexibility for adapting to different contexts and the possibility of using non-standardized instruments as well as a high degree of development in specific software and data analysis. Although the importance and usefulness of sports-related observational studies have been widely shown, there is no checklist to report these studies. Consequently, authors do not have a guide to follow in order to include all of the important elements in an observational study in sports areas, and reviewers do not have a reference tool for assessing this type of work. To resolve these issues, this article aims to develop a checklist to measure the quality of sports-related observational studies based on a content validity study. The participants were 22 judges with at least 3 years of experience in observational studies, sports areas, and methodology. They evaluated a list of 60 items systematically selected and classified into 12 dimensions. They were asked to score four aspects of each item on 5-point Likert scales to measure the following dimensions: representativeness, relevance, utility, and feasibility. The judges also had an open-format section for comments. The Osterlind index was calculated for each item and for each of the four aspects. Items were considered appropriate when obtaining a score of at least 0.5 in the four assessed aspects. After considering these inclusion criteria and all of the open-format comments, the resultant checklist consisted of 54 items grouped into the same initial 12 dimensions. Finally, we highlight the strengths of this work. We also present its main limitation: the need to apply the resultant checklist to obtain data and, thus, increase quality indicators of its psychometric properties. For this reason, as relevant actions for further development, we encourage expert readers to use it and provide feedback; we plan to apply it to different sport areas.

Dataset Information

Reporting of Protocol Rationale and Content Validity in Randomized Clinical Trials of T'ai Chi: A Systematic Evaluation.

Publications

Reporting of Protocol Rationale and Content Validity in Randomized Clinical Trials of T'ai Chi: A Systematic Evaluation.

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