TY  - JOUR
AU  - Jayasinghe, Randi Thisakya
AU  - Ahern, Susannah
AU  - Maharaj, Ashika D
AU  - Romero, Lorena
AU  - Ruseckaite, Rasa
PY  - 2024
DA  - 2024/5/21
TI  - Identifying Existing Guidelines, Frameworks, Checklists, and Recommendations for Implementing Patient-Reported Outcome Measures: Protocol for a Scoping Review
JO  - JMIR Res Protoc
SP  - e52572
VL  - 13
KW  - patient-reported outcome measures
KW  - patient-reported outcomes
KW  - quality of life
KW  - clinical quality registry
KW  - guidelines
KW  - frameworks
KW  - recommendations
KW  - scoping review
KW  - patient perspectives
KW  - patient perspective
KW  - patient-reported outcome
KW  - patient-reported
KW  - clinical setting
KW  - clinical registry
KW  - registry
KW  - systematic review
AB  - Background: Implementing patient-reported outcome measures (PROMs) to measure and evaluate health outcomes is increasing worldwide. Along with this emerging trend, it is important to identify which guidelines, frameworks, checklists, and recommendations exist, and if and how they have been used in implementing PROMs, especially in clinical quality registries (CQRs). Objective: This review aims to identify existing publications, as well as publications that discuss the application of actual guidelines, frameworks, checklists, and recommendations on PROMs’ implementation for various purposes such as clinical trials, clinical practice, and CQRs. In addition, the identified publications will be used to guide the development of a new guideline for PROMs’ implementation in CQRs, which is the aim of the broader project. Methods: A literature search of the databases MEDLINE, Embase, CINAHL, PsycINFO, and Cochrane Central Register of Controlled Trials will be conducted since the inception of the databases, in addition to using Google Scholar and gray literature to identify literature for the scoping review. Predefined inclusion and exclusion criteria will be used for all phases of screening. Existing publications of guidelines, frameworks, checklists, recommendations, and publications discussing the application of those methodologies for implementing PROMs in clinical trials, clinical practice, and CQRs will be included in the final review. Data relating to bibliographic information, aim, the purpose of PROMs use (clinical trial, practice, or registries), name of guideline, framework, checklist and recommendations, the rationale for development, and their purpose and implications will be extracted. Additionally, for publications of actual methodologies, aspects or domains of PROMs’ implementation will be extracted. A narrative synthesis of included publications will be conducted. Results: The electronic database searches were completed in March 2024. Title and abstract screening, full-text screening, and data extraction will be completed in May 2024. The review is expected to be completed by the end of August 2024. Conclusions: The findings of this scoping review will provide evidence on any existing methodologies and tools for PROMs’ implementation in clinical trials, clinical practice, and CQRs. It is anticipated that the publications will help us guide the development of a new guideline for PROMs’ implementation in CQRs. Trial Registration: PROSPERO CRD42022366085; https://tinyurl.com/bdesk98x International Registered Report Identifier (IRRID): DERR1-10.2196/52572 
SN  - 1929-0748
UR  - https://www.researchprotocols.org/2024/1/e52572
UR  - https://doi.org/10.2196/52572
UR  - http://www.ncbi.nlm.nih.gov/pubmed/38771621
DO  - 10.2196/52572
ID  - info:doi/10.2196/52572
ER  -