Reporting quality was suboptimal in a systematic review of randomized controlled trials with adaptive designs

Purja, Sujata; Park, Sunuk; Oh, SuA; Kim, Minji; Kim, Eun Young

doi:10.1016/j.jclinepi.2022.12.010

Cited by 6 publications

(11 citation statements)

References 39 publications

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“…Concealed allocation associated with methodological quality was reported in only a few of the studies we investigated (six; 27.3%). In the previous quality reporting study, it was shown that the item of the least reported PEDro scale was concealed allocation [24,30]. Gonzalez et al [23] reported similar results (438; 31.2%).…”

Section: Discussionmentioning

confidence: 81%

Methodological quality of randomized controlled trials of home-based rehabilitation in knee osteoarthritis: A cross-sectional survey

Meltem¹,

Ünver²,

Engin³

2023

J Surg Med

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Background/Aim: This study aimed to evaluate the methodological quality of randomized controlled trials (RCTs) that examine home-based rehabilitation (HBR) trials for knee osteoarthritis (KOA) using the Physiotherapy Evidence Database (PEDro) scale and the nine methodology-related items of the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement. Methods: Three electronic databases were scanned from baseline to October 10, 2021. Two reviewers independently evaluated the articles according to the two inclusion criteria: (1) in individuals diagnosed with KOA, at least one group received home-based rehabilitation as a study intervention and (2) at least one group received a comparison intervention or no intervention. The methodological quality of the included studies (n=22) was assessed using the PEDro scale and nine items of the CONSORT 2010 statement. Results: Among 1557 RCTs, 22 studies that fulfilled our criteria were included in the review. The mean PEDro scale score was 5.77 (1.54). This result reflects moderate methodological quality. Concealed allocation (6; 27.3%), blinding of subjects (4; 18.2%), and (0; 0.0%) of therapists associated with the methodological quality were not reported in most studies. An author’s expertise in epidemiology and/or statistics was 0.78 points (95% confidence interval [CI] 0.11–1.44), the multicenter study 0.94 points (95% CI: 0.19–1.68), and a one-unit increase in the total score of the CONSORT statement led to an increase in methodological quality of 0.55 points (95% CI: 0.34–0.76). Conclusion: The methodological quality of most RCTs examining HBR in KOA that we included in our systematic review was moderate. The adherence of journals and authors to CONSORT checklists in reporting of studies may lead to an improvement in the methodological quality of future published studies.

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Section: Discussionmentioning

confidence: 81%

Methodological quality of randomized controlled trials of home-based rehabilitation in knee osteoarthritis: A cross-sectional survey

Meltem¹,

Ünver²,

Engin³

2023

J Surg Med

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“…A comprehensive risk-of-bias tool is needed to facilitate the publication of high-quality ACTs and any future pooled analyses of ACTs. A recent scoping review of ACTs has demonstrated poor reporting based on the CONSORT-ACE guidelines [31]. We are, therefore, going to use the framework developed by Whiting and colleagues to develop a new risk-of-bias tool for randomized trials with adaptive design features [27].…”

Section: Discussionmentioning

confidence: 99%

“…We will also search clinical trials registries including clinicaltrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP). All searches for peer-review ACTs will be performed from the end date of the scoping review of ACTs published by Purja and colleagues [31]. We will search the following grey literature databases and resources: the EQUATOR network, dissertation abstracts, websites of evidence synthesis organizations (e.g., Campbell Collaboration, Cochrane Multiple Treatments Group, CADTH, NICE-DSU, Health Technology Assessment International (HTAi), Pharmaceutical Benefits Advisory Committee, Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, European Network for Health Technology Assessment, Guidelines International Network, ISPOR, International Network of Agencies for Health Technology Assessment, and JBI), and methods collections (e.g., Cochrane Methodology Register, AHRQ Effective Healthcare Programme).…”

Section: Methodsmentioning

confidence: 99%

Methodological review to develop a list of bias items for adaptive clinical trials: Protocol and rationale

Staibano,

McKechnie,

Thabane

et al. 2024

Preprint

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Background Randomized-clinical trials (RCTs) are the gold-standard for comparing health care interventions, but can be limited by early termination, feasibility issues, and prolonged time to trial reporting. In contrast, adaptive clinical trials (ACTs), which are defined by pre-planned modifications and analyses that occur after starting patient recruitment, are gaining popularity as they can streamline trial design and time to reporting. As adaptive methodologies continue to be adopted by researchers, it will be critical to develop a risk-of-bias tool that evaluates the unique methodological features of ACTs so that their quality can be improved and standardized for the future. In our proposed methodological review, we plan to develop a list of risk-of-bias items for ACTs to develop a candidate instrument. Methods and analysis We will perform a systematic database search to capture: (1) ACTs published in any discipline of medicine and/or surgery; and (2) studies that have proposed or reviewed items pertaining to methodological risk, bias, and/or quality in ACTs. We will perform a comprehensive search of citation databases, such as Ovid MEDLINE, EMBASE, CENTRAL, the Cochrane library, and Web of Science, in addition to multiple grey literature sources to capture published and unpublished literature related to ACTs and studies evaluating the methodological quality of ACTs. We will also search methodological registries for any risk of bias tools for ACTs. All screening and review stages will be performed in duplicate with a third senior author serving as arbitrator for any discrepancies. Included ACTs will be analyzed in a descriptive manner, and we will perform regression analysis to identify factors associated with poor reporting quality and high risk of bias. We will also perform a risk of bias assessment of ACTs using the Cochrane risk-of-bias 2.0 tool and we will assess reporting quality using the CONSORT-ACE tool. These assessments will be performed independently and in duplicate. This will be done to help generate risk of bias concepts, themes, and items that can be included in the candidate tool. For all studies of methodological quality and risk of bias, we will extract all pertinent bias items and/or tools. We will combine conceptually similar items in a descriptive manner and classify them as referring to bias or to other aspects of methodological quality, such as reporting. We will plan to generate pertinent risk of bias items and fields and finally, a candidate tool that will undergo further refinement, testing, and validation in future development stages. Ethics and dissemination This review does not require ethics approval as human subjects are not involved. As mentioned previously, this study is the first step in developing a tool to evaluate the risk of bias and methodological quality of ACTs.

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“…Adaptive group sequential Trials can be stopped prematurely for efficacy, futility, or harm and protocol adaptations made to sample size, study endpoints, hypotheses, dose, treatment duration, randomization schedules, or number and content of treatment arms (Bothwell et al, 2018;Chow & Chang, 2008;Purja et al, 2022).…”

Section: Adaptive Design Definitionmentioning

confidence: 99%

“…Sample size re-estimation Allows adjustment to the planned sample size either blind or unblind to treatment allocation (Bothwell et al, 2018;Purja et al, 2022) based on treatment effect sizes, conditional power or reproducibility probability (Chuang-Stein et al, 2006;James Hung et al, 2005).…”

Section: Adaptive Treatment Arm Switchingmentioning

confidence: 99%

Adaptive design trials in eating disorder research: A scoping review

Edney,

Pellizzer

2024

Intl J Eating Disorders

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ObjectiveThis scoping review sought to map the breadth of literature on the use of adaptive design trials in eating disorder research.MethodA systematic literature search was conducted in Medline, Scopus, PsycInfo, Emcare, Econlit, CINAHL and ProQuest Dissertations and Theses. Articles were included if they reported on an intervention targeting any type of eating disorder (including anorexia nervosa, bulimia nervosa, binge‐eating disorder, and other specified feeding or eating disorders), and employed the use of an adaptive design trial to evaluate the intervention. Two independent reviewers screened citations for inclusion, and data abstraction was performed by one reviewer and verified by a second.ResultsWe identified five adaptive design trials targeting anorexia nervosa, bulimia nervosa and binge‐eating disorder conducted in the USA and Australia. All employed adaptive treatment arm switching based on early response to treatment and identified a priori stopping rules. None of the studies included value of information analysis to guide adaptive design decisions and none included lived experience perspectives.DiscussionThe limited use of adaptive designs in eating disorder trials represents a missed opportunity to improve enrolment targets, attrition rates, treatment outcomes and trial efficiency. We outline the range of adaptive methodologies, how they could be applied to eating disorder research, and the specific operational and statistical considerations relevant to adaptive design trials.Public significanceAdaptive design trials are increasingly employed as flexible, efficient alternatives to fixed trial designs, but they are not often used in eating disorder research. This first scoping review identified five adaptive design trials targeting anorexia nervosa, bulimia nervosa and binge‐eating disorder that employed treatment arm switching adaptive methodology. We make recommendations on the use of adaptive design trials for future eating disorder trials.

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Reporting quality was suboptimal in a systematic review of randomized controlled trials with adaptive designs

Cited by 6 publications

References 39 publications

Methodological quality of randomized controlled trials of home-based rehabilitation in knee osteoarthritis: A cross-sectional survey

Methodological quality of randomized controlled trials of home-based rehabilitation in knee osteoarthritis: A cross-sectional survey

Methodological review to develop a list of bias items for adaptive clinical trials: Protocol and rationale

Adaptive design trials in eating disorder research: A scoping review

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