Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: A repeated cross-sectional study

Lohner, Szimonetta; Gryaznov, Dmitry; Niederhäusern, Belinda von; Speich, Benjamin; Kasenda, Benjamin; Ojeda-Ruiz, Elena; Schandelmaier, Stefan; Mertz, Dominik; Odutayo, Ayodele; Tomonaga, Yuki; Amstutz, Alain; Pauli‐Magnus, Christiane; Gloy, Viktoria; Bischoff, Karin; Wollmann, Katharina; Rehner, Laura; Meerpohl, Joerg J; Nordmann, Alain; Klatte, Katharina; Ghosh, Nilabh; Heravi, Ala Taji; Wong, Jacqueline; Chow, Ngai; Hong, Patrick Jiho; McCord, Kimberly A; Sricharoenchai, Sirintip; Busse, Jason W.; Agarwal, Arnav; Saccilotto, Ramon; Schwenkglenks, Matthias; Moffa, Giusi; Hemkens, Lars G.; Hopewell, Sally; Elm, Erik von; Blümle, Anette; Briel, Matthias

doi:10.1016/j.jclinepi.2021.05.011

Cited by 10 publications

(8 citation statements)

References 32 publications

(29 reference statements)

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“…Third, the SPIRIT checklist was created as a reporting guideline and not as a measurement tool for reporting quality [ 27 ]. However, we carefully operationalized the SPIRIT checklist and conducted various sensitivity analyses before using reporting quality estimates for the present study [ 15 , 17 ]. Fourth, we used trial protocols approved by RECs in Switzerland, the UK, Germany, and Canada, and the generalizability of our findings to RCT protocols approved by other RECs in these or other countries is uncertain.…”

Section: Discussionmentioning

confidence: 99%

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Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis

et al. 2022

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Background We previously found that 25% of 1,017 randomized clinical trials (RCTs) approved between 2000 and 2003 were discontinued prematurely, and 44% remained unpublished at a median of 12 years follow-up. We aimed to assess a decade later (1) whether rates of completion and publication have increased; (2) the extent to which nonpublished RCTs can be identified in trial registries; and (3) the association between reporting quality of protocols and premature discontinuation or nonpublication of RCTs. Methods and findings We included 326 RCT protocols approved in 2012 by research ethics committees in Switzerland, the United Kingdom, Germany, and Canada in this metaresearch study. Pilot, feasibility, and phase 1 studies were excluded. We extracted trial characteristics from each study protocol and systematically searched for corresponding trial registration (if not reported in the protocol) and full text publications until February 2022. For trial registrations, we searched the (i) World Health Organization: International Clinical Trial Registry Platform (ICTRP); (ii) US National Library of Medicine (ClinicalTrials.gov); (iii) European Union Drug Regulating Authorities Clinical Trials Database (EUCTR); (iv) ISRCTN registry; and (v) Google. For full text publications, we searched PubMed, Google Scholar, and Scopus. We recorded whether RCTs were registered, discontinued (including reason for discontinuation), and published. The reporting quality of RCT protocols was assessed with the 33-item SPIRIT checklist. We used multivariable logistic regression to examine the association between the independent variables protocol reporting quality, planned sample size, type of control (placebo versus other), reporting of any recruitment projection, single-center versus multicenter trials, and industry versus investigator sponsoring, with the 2 dependent variables: (1) publication of RCT results; and (2) trial discontinuation due to poor recruitment. Of the 326 included trials, 19 (6%) were unregistered. Ninety-eight trials (30%) were discontinued prematurely, most often due to poor recruitment (37%; 36/98). One in 5 trials (21%; 70/326) remained unpublished at 10 years follow-up, and 21% of unpublished trials (15/70) were unregistered. Twenty-three of 147 investigator-sponsored trials (16%) reported their results in a trial registry in contrast to 150 of 179 industry-sponsored trials (84%). The median proportion of reported SPIRIT items in included RCT protocols was 69% (interquartile range 61% to 77%). We found no variables associated with trial discontinuation; however, lower reporting quality of trial protocols was associated with nonpublication (odds ratio, 0.71 for each 10% increment in the proportion of SPIRIT items met; 95% confidence interval, 0.55 to 0.92; p = 0.009). Study limitations include that the moderate sample size may have limited the ability of our regression models to identify significant associations. Conclusions We have observed that rates of premature trial discontinuation have not changed in the past decade. Nonpublication of RCTs has declined but remains common; 21% of unpublished trials could not be identified in registries. Only 16% of investigator-sponsored trials reported results in a trial registry. Higher reporting quality of RCT protocols was associated with publication of results. Further efforts from all stakeholders are needed to improve efficiency and transparency of clinical research.

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Section: Discussionmentioning

confidence: 99%

“…Reviewers determined, independently and in duplicate (for over 75% of included protocols), the reporting quality of all eligible RCT protocols by assessing the proportion of SPIRIT checklist items met [ 15 – 17 ].…”

Section: Methodsmentioning

confidence: 99%

Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis

et al. 2022

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“…This might be in connection with the strict regulations surrounding drug trials. Differences in protocol quality ( 19 ) registration and publication tendencies were described already in previous publications ( 20 , 21 ), between trials with regulated and non-regulated interventions.…”

Section: Discussionmentioning

confidence: 60%

Methodological Quality and Risk of Bias Assessment of Cardiovascular Disease Research: Analysis of Randomized Controlled Trials Published in 2017

Baasan

Freihat

Nagy

et al. 2022

Front. Cardiovasc. Med.

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BackgroundAll randomized-controlled trials (RCTs) are required to follow high methodological standards. In this study, we aimed to assess the methodological quality of published cardiovascular clinical research trials in a representative sample of RCTs published in 2017.MethodsCochrane Central Register of Controlled Trials was used to identify cardiovascular clinical research trials with adult participants published in 2017. Overall, 250 (10%) RCTs were randomly selected from a total of 2,419 studies. Data on general trial characteristics were extracted and the risk of bias (RoB) was determined.ResultsOverall, 86% of RCTs have reported at least one statistically significant result, with the primary outcome significant in 69%, treatment favored in 55%, and adverse events reported in 68%. Less than one-third (29%) of trials were overall low RoB, while the other two-thirds were rated unclear (40%) or with high RoB (31%). Sequence generation, allocation concealment, and selective reporting were the domains most often rated with high RoB. Drug trials were more likely to have low RoB than non-drug trials. Significant differences were found in RoB for the allocation concealment and blinding of participants and personnel between industry-funded and non-industry-funded trials, with industry-funded trials more often rated at low RoB.ConclusionAlmost two-thirds of RCTs in the field of cardiovascular disease (CVD) research, were at high or unclear RoB, indicating a need for more rigorous trial planning and conduct. Prospective trial registration is a factor predicting a lower risk of bias.

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“… 5–7 Examples of such approaches include determining baseline dietary patterns, assessing prospective food intake assessment and using appropriate data analysis techniques (eg, adjusting for total energy intake, 8 confirmatory factor analysis 9 and principal component analysis applied to dietary patterns 10 ). Unlike highly regulated drug trials, diet and nutrition-related RCTs are not subject to oversight by regulatory agencies, 11 which might explain the lack of reporting of essential details in papers describing non-regulated RCTs. 12 13 Indeed, the available reporting guidelines were not specifically designed for nutrition or diet-related RCTs.…”

Section: Introductionmentioning

confidence: 99%

“… 14 As of 1 December 2021, the primary SPIRIT publication presenting a checklist of items to include in RCT protocols had been cited more than 2000 times, according to Clarivate’s Web of Science. Reporting completeness of all RCT protocols 15 and non-regulated RCTs 11 has improved since SPIRIT’s publication. Item 5 of the Consolidated Standards of Reporting Trials 2010 statement 16 and item 11 of the SPIRIT 2013 statement provide guidance for reporting an RCT’s intervention.…”

Section: Introductionmentioning

confidence: 99%

Protocol for a meta-research study of protocols for diet or nutrition-related trials published in indexed journals: general aspects of study design, rationale and reporting limitations

Silva

Adegboye

Curioni³

et al. 2022

BMJ Open

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IntroductionThe Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) reporting guideline establishes a minimum set of items to be reported in any randomised controlled trial (RCT) protocol. The Template for Intervention Description and Replication (TIDieR) reporting guideline was developed to improve the reporting of interventions in RCT protocols and results papers. Reporting completeness in protocols of diet or nutrition-related RCTs has not been systematically investigated. We aim to identify published protocols of diet or nutrition-related RCTs, assess their reporting completeness and identify the main reporting limitations remaining in this field.Methods and analysisWe will conduct a meta-research study of RCT protocols published in journals indexed in at least one of six selected databases between 2012 and 2022. We have run a search in PubMed, Embase, CINAHL, Web of Science, PsycINFO and Global Health using a search strategy designed to identify protocols of diet or nutrition-related RCTs. Two reviewers will independently screen the titles and abstracts of records yielded by the search in Rayyan. The full texts will then be read to confirm protocol eligibility. We will collect general study features (publication information, types of participants, interventions, comparators, outcomes and study design) of all eligible published protocols in this contemporary sample. We will assess reporting completeness in a randomly selected sample of them and identify their main reporting limitations. We will compare this subsample with the items in the SPIRIT and TIDieR statements. For all data collection, we will use data extraction forms in REDCap. This protocol is registered on the Open Science Framework (DOI:10.17605/OSF.IO/YWEVS).Ethics and disseminationThis study will undertake a secondary analysis of published data and does not require ethical approval. The results will be disseminated through journals and conferences targeting stakeholders involved in nutrition research.

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Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: A repeated cross-sectional study

Abstract: Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: a repeated cross-sectional study,

Cited by 10 publications

References 32 publications

Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis

Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis

Methodological Quality and Risk of Bias Assessment of Cardiovascular Disease Research: Analysis of Randomized Controlled Trials Published in 2017

Protocol for a meta-research study of protocols for diet or nutrition-related trials published in indexed journals: general aspects of study design, rationale and reporting limitations

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