Do patients with chronic low-back pain experience a loss of health-related quality of life? A protocol for a systematic review and meta-analysis

Introduction: Health-related quality of life in chronic low back pain (LBP) is an important issue since various individual factors such as perceived loss of autonomy, inability to continue daily life and anxiety can contribute to maintenance or deterioration of this condition. Health-related quality of life is also important because it can predict the probability of recovery or recrudescence over time. In the literature, there is no systematic review on this topic. The present paper describes a protocol of the first systematic review and meta-analysis aimed at summarising the data on health-related quality of life in patients with chronic LBP compared with healthy controls. Gender, age and comorbidity of psychiatric disorders (mood or anxiety disorders) will be explored as moderators. Studies will be included if they used a case-control design comparing adults with chronic LBP to healthy controls on health-related quality of life through validated interviews/questionnaires. Methods and analysis: According to Preferred Reporting Items for Systematic Reviews and Meta-Analyses, a systematic review and meta-analysis will be conducted from 10th to 17th January 2020. Independent reviewers will search published/unpublished studies through electronic databases (Scopus, PubMed, EMBASE and the Cochrane Library) and additional sources, will extract the data and assess the methodological quality through the Newcastle-Ottawa Scale. Random-effect meta-analysis will be carried out by calculating effect sizes as Cohen's d indices. Publication bias will be assessed and moderators of the effect sizes will be investigated through weighted least squares meta-regression.The knowledge whether health-related quality of life is better or worse as a function of some individual characteristics may suggest personalised care pathways according to a precision medicine approach. Ethics and dissemination: The current review does not require ethics approval. The results will be disseminated through publications in peer-reviewed journals. Prospero registration number: CRD42019131749.