Background: Systematic reviews (SRs) of patient-reported outcome measures (PROMs) are an important way to select the appropriate PROMs. High-quality SRs can provide a comprehensive overview of the PROMs and provide evidence-based recommendations for pediatricians. However, because the risk of bias evaluation of included studies, data extraction and analysis are different from other types of SRs, and there are currently no tools applicable to evaluate risk of bias of SRs of PROMs.
Objectives: We aim to develop an evidence-based methodological quality evaluation tool for SRs of PROMs using an explicit, systematic and transparent method: a critical apPRaisal tOol for systeMatic reviews of patient-repOrted ouTcome mEasures (PROMOTE).
Methods: We will develop the PROMOTE in five stages using established methods. First, we establish an international and multidisciplinary advisory committee of experts who will oversee the project and provide methodological support. Second, we will develop an initial checklist item list using a scoping review to describe the entries of existing SRs of risk of bias checklists and the methodological characteristics of published SRs of PROMs. Third, 10 SRs of PROMs will be randomly selected using the random number table, and methodological quality will be evaluated by four researchers using the initial checklist item list. The initial items will be modified, added or deleted through focus group discussion. Fourth, we will use a two-round Delphi designed to achieve a high level of expert consensus on the list of items for PROMOTE. We will recruit 30 multidisciplinary international experts, including journal editors, clinical researchers, patient-reported outcomes researchers, guideline developers, policy makers and patients who will participate in the Delphi process. Fifth, after reaching consensus on the items included, we will produce and disseminate PROMOTE risk of bias checklist. Discussion: A systematically developed critical appraisal tool for SRs of PROMs would facilitate the selection of appropriate PROMs in clinical practice or research. A well-defined and transparent critical appraisal tool would further improve the methodological quality of SRs while reducing study waste and ultimately supporting optimal patient health outcomes. Patient or consumer involvement: Patients and consumers will be directly involved in the Delphi process as expert participants.