TY - JOUR
T1 - Protocol for a meta-research study of protocols for diet or nutrition-related trials published in indexed journals
T2 - general aspects of study design, rationale and reporting limitations
AU - Silva, Flávia Moraes
AU - Adegboye, Amanda Rodrigues Amorim
AU - Curioni, Cintia
AU - Gomes, Fabio S.
AU - Collins, Gary Stephen
AU - Kac, Gilberto
AU - A De Beyer, Jennifer
AU - Cook, Jonathan Alistair
AU - Cheikh Ismail, Leila
AU - Page, Matthew J.
AU - Khandpur, Neha
AU - Lamb, Sarah
AU - Hopewell, Sally
AU - Kirtley, Shona
AU - Durão, Solange
AU - Vorland, Colby J.
AU - M Schlussel, Michael
N1 - © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2022/12/26
Y1 - 2022/12/26
N2 - INTRODUCTION: The 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 ANALYSIS: We 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 DISSEMINATION: This 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.
AB - INTRODUCTION: The 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 ANALYSIS: We 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 DISSEMINATION: This 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.
KW - Clinical Trials
KW - Data Collection
KW - Diet
KW - Humans
KW - Nutritional Status
KW - Periodicals as Topic
KW - Protocols & Guidelines
KW - Randomized Controlled Trials as Topic
KW - Research Design
KW - epidemiology
UR - http://www.scopus.com/inward/record.url?scp=85144636728&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2022-064744
DO - 10.1136/bmjopen-2022-064744
M3 - Article
C2 - 36572499
AN - SCOPUS:85144636728
SN - 2044-6055
VL - 12
JO - BMJ Open
JF - BMJ Open
IS - 12
M1 - e064744
ER -