Evaluation of the psychometric properties of patient-reported and clinician-reported outcome measures of chemotherapy-induced peripheral neuropathy: a COSMIN systematic review protocol

Abstract

Introduction Chemotherapy-induced peripheral neuropathy (CIPN) is a poorly understood side effect of many antineoplastic agents. Patients may experience sensory, motor and autonomic symptoms, negatively impacting quality of life. A gold-standard assessment methodology has yet to be determined, limiting efforts to identify effective agents to prevent or treat CIPN.Methods and analysis This is a protocol of a systematic review of psychometric analyses of CIPN Clinician Reported Outcome Measures (ClinROM) and Patient-Reported Outcome Measures (PROM) among adults receiving, or who had previously received chemotherapy for cancer. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) quality ratings will be compared across studies and across ClinROMs and PROMs. Studies reporting psychometric proprieties of CIPN ClinROMs and/or PROMs among adults aged ≥18 years will be eligible for inclusion, with no restriction on language or year of publication. MEDLINE, Embase, CINAHL and APA PsycINFO databases will be searched from inception to 31 December 2021. Study characteristics, measurement properties of the ClinROMs and/or PROMs and the CIPN definitions will be extracted. The Synthesis Without Meta-analysis guideline will be used to guide data synthesis. The COSMIN Risk of Bias checklist will be used by two independent raters to assess methodological quality. Subgroup analyses by age, chemotherapy type, and study timing in relation to the delivery of chemotherapy will be carried out where data are available. An adapted version of Outcome Measures in Rheumatology filter 2.1 will be used to provide a best-evidence synthesis of CIPN ClinROMs and PROMs and to recommend a CIPN assessment tool for clinical and research settings.Ethics and dissemination Ethical approval is not necessary to be obtained for this systematic review protocol. Results will be disseminated to clinicians and policy-makers by publication in a peer-reviewed journal and by presenting at relevant conferences.PROSPERO registration number CRD42021278168.