TY - JOUR
T1 - Reporting completeness of nutrition and diet-related randomised controlled trials protocols
AU - Silva, Flávia Moraes
AU - Amorim Adegboye, Amanda Rodrigues
AU - Curioni, Cintia
AU - Gomes, Fabio
AU - Collins, Gary S.
AU - Kac, Gilberto
AU - Cook, Jonathan
AU - Ismail, Leila Cheikh
AU - Page, Matthew J.
AU - Khandpur, Neha
AU - Lamb, Sarah
AU - Hopewell, Sally
AU - Saleh, Shaima
AU - Kirtley, Shona
AU - Bernardes, Simone
AU - Durão, Solange
AU - Vorland, Colby J.
AU - Lima, Júlia
AU - Rebelo, Fernanda
AU - Cunha Figueiredo, Amanda C.
AU - Braga Tibaes, Jenneffer Rayane
AU - Tavares, Marina
AU - da Silva Fink, Jaqueline
AU - Maia de Sousa, Taciana
AU - Chester-Jones, Mae
AU - Bi, Dongquan
AU - Naude, Celeste
AU - Schlussel, Michael
N1 - Funding Information:
Michael Maia Schlussel, Shona Kirtley, Jennifer A de Beyer and Gary Collins are funded by Cancer Research UK (grant C49297/A27294). Matthew J Page is supported by an Australian Research Council Discovery Early Career Researcher Award (DE200101618). Colby Vorland has received honoraria from The Obesity Society and the Alliance for Potato Research and Education, and his university has received funds to support his research from: National Cattlemen's Beef Association; Alliance for Potato Research and Education; the Gordon and Betty Moore Foundation; and NIH. All authors work directly or have collaborations with the EQUATOR Network, an international initiative that seeks to improve the reliability and value of published health research literature by promoting transparent and accurate reporting and wider use of robust reporting guidelines.
Publisher Copyright:
© 2024
PY - 2024/7
Y1 - 2024/7
N2 - Background and aims: There is a need to consolidate reporting guidance for nutrition randomised controlled trial (RCT) protocols. The reporting completeness in nutrition RCT protocols and study characteristics associated with adherence to SPIRIT and TIDieR reporting guidelines are unknown. We, therefore, assessed reporting completeness and its potential predictors in a random sample of published nutrition and diet-related RCT protocols. Methods: We conducted a meta-research study of 200 nutrition and diet-related RCT protocols published in 2019 and 2021 (aiming to consider periods before and after the start of the COVID pandemic). Data extraction included bibliometric information, general study characteristics, compliance with 122 questions corresponding to items and subitems in the SPIRIT and TIDieR checklists combined, and mention to these reporting guidelines in the publications. We calculated the proportion of protocols reporting each item and the frequency of items reported for each protocol. We investigated associations between selected publication aspects and reporting completeness using linear regression analysis. Results: The majority of protocols included adults and elderly as their study population (n = 73; 36.5%), supplementation as intervention (n = 96; 48.0%), placebo as comparator (n = 89; 44.5%), and evaluated clinical status as the outcome (n = 80; 40.0%). Most protocols described a parallel RCT (n = 188; 94.0%) with a superiority framework (n = 141; 70.5%). Overall reporting completeness was 52.0% (SD = 10.8%). Adherence to SPIRIT items ranged from 0% (n = 0) (data collection methods) to 98.5% (n = 197) (eligibility criteria). Adherence to TIDieR items ranged from 5.5% (n = 11) (materials used in the intervention) to 98.5% (n = 197) (description of the intervention). The multivariable regression analysis suggests that a higher number of authors [β = 0.53 (95%CI: 0.28–0.78)], most recent published protocols [β = 3.19 (95%CI: 0.24–6.14)], request of reporting guideline checklist during the submission process by the journal [β = 6.50 (95%CI: 2.56–10.43)] and mention of SPIRIT by the authors [β = 5.15 (95%CI: 2.44–7.86)] are related to higher reporting completeness scores. Conclusions: Reporting completeness in a random sample of 200 diet or nutrition-related RCT protocols was low. Number of authors, year of publication, self-reported adherence to SPIRIT, and journals' endorsement of reporting guidelines seem to be positively associated with reporting completeness in nutrition and diet-related RCT protocols.
AB - Background and aims: There is a need to consolidate reporting guidance for nutrition randomised controlled trial (RCT) protocols. The reporting completeness in nutrition RCT protocols and study characteristics associated with adherence to SPIRIT and TIDieR reporting guidelines are unknown. We, therefore, assessed reporting completeness and its potential predictors in a random sample of published nutrition and diet-related RCT protocols. Methods: We conducted a meta-research study of 200 nutrition and diet-related RCT protocols published in 2019 and 2021 (aiming to consider periods before and after the start of the COVID pandemic). Data extraction included bibliometric information, general study characteristics, compliance with 122 questions corresponding to items and subitems in the SPIRIT and TIDieR checklists combined, and mention to these reporting guidelines in the publications. We calculated the proportion of protocols reporting each item and the frequency of items reported for each protocol. We investigated associations between selected publication aspects and reporting completeness using linear regression analysis. Results: The majority of protocols included adults and elderly as their study population (n = 73; 36.5%), supplementation as intervention (n = 96; 48.0%), placebo as comparator (n = 89; 44.5%), and evaluated clinical status as the outcome (n = 80; 40.0%). Most protocols described a parallel RCT (n = 188; 94.0%) with a superiority framework (n = 141; 70.5%). Overall reporting completeness was 52.0% (SD = 10.8%). Adherence to SPIRIT items ranged from 0% (n = 0) (data collection methods) to 98.5% (n = 197) (eligibility criteria). Adherence to TIDieR items ranged from 5.5% (n = 11) (materials used in the intervention) to 98.5% (n = 197) (description of the intervention). The multivariable regression analysis suggests that a higher number of authors [β = 0.53 (95%CI: 0.28–0.78)], most recent published protocols [β = 3.19 (95%CI: 0.24–6.14)], request of reporting guideline checklist during the submission process by the journal [β = 6.50 (95%CI: 2.56–10.43)] and mention of SPIRIT by the authors [β = 5.15 (95%CI: 2.44–7.86)] are related to higher reporting completeness scores. Conclusions: Reporting completeness in a random sample of 200 diet or nutrition-related RCT protocols was low. Number of authors, year of publication, self-reported adherence to SPIRIT, and journals' endorsement of reporting guidelines seem to be positively associated with reporting completeness in nutrition and diet-related RCT protocols.
KW - Intervention
KW - Nutrition
KW - Protocols
KW - Randomised controlled trials
KW - Reporting guidelines
UR - https://www.scopus.com/pages/publications/85193854015
U2 - 10.1016/j.clnu.2024.04.038
DO - 10.1016/j.clnu.2024.04.038
M3 - Article
C2 - 38795681
AN - SCOPUS:85193854015
SN - 0261-5614
VL - 43
SP - 1626
EP - 1635
JO - Clinical Nutrition
JF - Clinical Nutrition
IS - 7
ER -