Outcomes evaluating quality of life and their measurement properties in early-onset scoliosis: protocol for a systematic review

Introduction Early-onset scoliosis (EOS) is a rare spinal deformity affecting children under the age of 10. Both the condition and its treatment have associated morbidity and can impact quality of life. Understanding this impact can be achieved by using appropriate patient-reported and/or carer-reported outcome measures. The aim of the review described in this protocol is to evaluate the evidence on measurement properties relevant to health-related quality of life outcomes in the EOS population. The focus will be on outcome measures relevant to patients undergoing treatment of EOS under the age of 10. Methods/analysis This protocol is reported in line with Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol and COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) methodology. The MEDLINE, EMBASE, EMCARE, PubMed, PsychINFO and CINAHL databases will be searched using a two-stage search strategy. The first stage will identify measures of HRQoL used in EOS through screening of titles and abstracts. The second stage will assess the measurement properties of those measures identified through screening of full-text articles. The measurement properties of interest are the 'reliability', 'validity' and 'responsiveness' of the instrument. Only English language articles will be considered. Two reviewers will independently review the search results against the eligibility criteria, perform data extraction and assess for risk of bias, with disputes handled by a third reviewer. Data will be quantitatively pooled where possible or reported as a narrative synthesis. The summarised results for each measurement property will be rated against the criteria for good measurement properties following the COSMIN methodology. Two reviewers will assess the body of evidence for each measurement property using modified Grading of Recommendations, Assessment, Development and Evaluation guidelines. Ethics and dissemination No ethical approval is required for this review and the results will be submitted for publication in peer-reviewed publications. PROSPERO registration number CRD42020219721.

Automated summary

Early-onset scoliosis (EOS) is a rare spinal deformity affecting children under the age of 10, with associated morbidity and impact on quality of life. This review aims to evaluate the evidence on measurement properties relevant to health-related quality of life outcomes in the EOS population, focusing on patients undergoing treatment under the age of 10. The study will assess the measurement properties of reliability, validity, and responsiveness of the instrument, with findings to be rated against criteria for good measurement properties following the COSMIN methodology.