Developing an international consensus Reporting guideline for intervention Fidelity in Non-Drug, non-surgical trials: The ReFiND protocol.

Sousa Filho, Luis Fernando; Farlie, Melanie K; Haines, Terry; Borrelli, Belinda; Carroll, Christopher; Mathews, Catherine; Ribeiro, Daniel C; Fritz, Julie M; Underwood, Martin; Foster, Nadine E; Lamb, Sarah E; Sanchez, Zila M; Malliaras, Peter

Abstract

Inadequate reporting of fidelity to interventions in trials limits the transparency and interpretation of trial findings. Despite this, most trials of non-drug, non-surgical interventions lack comprehensive reporting of fidelity. If fidelity is poorly reported, it is unclear which intervention components were tested or implemented within the trial, which also hinders research reproducibility. This protocol describes the development process of a reporting guideline for fidelity of non-drug, non-surgical interventions (ReFiND) in the context of trials. The ReFiND guideline will be developed in six stages. Stage one: a guideline development group has been formed to oversee the guideline methodology. Stage two: a scoping review will be conducted to identify and summarize existing guidance documents on the fidelity of non-drug, non-surgical interventions. Stage three: a Delphi study will be conducted to reach consensus on reporting items. Stage four: a consensus meeting will be held to consolidate the reporting items and discuss the wording and structure of the guideline. Stage five: a guidance statement, an elaboration and explanation document, and a reporting checklist will be developed. Stage six: different strategies will be used to disseminate and implement the ReFiND guideline. The ReFiND guideline will provide a set of items developed through international consensus to improve the reporting of intervention fidelity in trials of non-drug, non-surgical interventions. This reporting guideline will enhance transparency and reproducibility in future non-drug, non-surgical intervention research. [Abstract copyright: Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.]

Citation

Sousa Filho, L. F., Farlie, M. K., Haines, T., Borrelli, B., Carroll, C., Mathews, C., …Malliaras, P. (2024). Developing an international consensus Reporting guideline for intervention Fidelity in Non-Drug, non-surgical trials: The ReFiND protocol. Contemporary Clinical Trials, 142, Article 107575. https://doi.org/10.1016/j.cct.2024.107575

• Journal Article Type: Article
• Acceptance Date: May 11, 2024
• Online Publication Date: May 13, 2024
• Publication Date: 2024-07
• Deposit Date: Jun 3, 2024
• Journal: Contemporary clinical trials
• Print ISSN: 1551-7144
• Electronic ISSN: 1559-2030
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 142
• Article Number: 107575
• DOI: https://doi.org/10.1016/j.cct.2024.107575
• Keywords: Research report, Fidelity, Reproducibility of results, Clinical trials as topic, Program evaluation, Research design
• Public URL: https://keele-repository.worktribe.com/output/844681
• Publisher URL: https://www.sciencedirect.com/science/article/pii/S1551714424001587?via%3Dihub