Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 12, 2019
Open Peer Review Period: Jul 15, 2019 - Jul 29, 2019
Date Accepted: Feb 26, 2020
(closed for review but you can still tweet)
Patient-reported outcome measures in cystic fibrosis: protocol for a systematic review
ABSTRACT
Background:
Patients with cystic fibrosis (CF) can struggle with burdensome symptoms and treatment regimen which negatively affect every aspect of their life. As physiological parameters can fail to capture these complications, the assessment of health-related quality of life (HRQOL) has gained prominence. HRQOL can be measured using standardised questionnaires completed by patients called patient-reported outcome measures (PROMs). The Australian Cystic Fibrosis Data Registry (ACFDR) collects clinical data on adult and paediatric patients with CF. The incorporation of PROMs into the ACFDR would enable monitoring of HRQOL trends, benchmarking of HRQOL outcomes and support HRQOL research in CF.
Objective:
Prior to incorporation of a PROM in the ACFDR, this systematic review was planned to evaluate whether any suitable PROMs are currently being used in CF.
Methods:
This systematic review will be conducted in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) guidelines. MEDLINE, EMBASE, Scopus, CINAHL, PsycINFO and Cochrane Library databases will be searched for articles published between January 2009 and February 2019 describing the use of PROMs to measure HRQOL in adult and peadiatric patients with CF. Study designs including review, observational studies and validation studies will be included. Studies published in a language other than English or describing randomised control trials, dissertations, books, guideline statements and abstracts will be excluded. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) risk of bias checklist will be used to the methodological quality of included studies. A descriptive synthesis of results will be undertaken in line with the outcomes of this study.
Results:
As of July 2019, the search has been conducted and 4530 records screened. After two phases of screening, 98 studies were included in the final review and underwent data extraction. Reviewers are currently in the process of critical appraisal.
Conclusions:
This review will identify PROM(s) that may be used to measure HRQOL in the ACFDR.
Citation
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