Abstract
BACKGROUND: The availability of high-quality patient-reported outcome (PRO) data is crucial to guiding shared decision-making in the context of locally recurrent rectal cancer (LRRC), where potential treatment benefits must be balanced against the impact of both the disease and treatment on PROs, such as quality of life. This review aimed to identify the patient-reported outcome measures (PROMs) currently being reported in LRRC and to appraise the methodological quality of studies using these measures. METHODS: PubMed, Embase and CINAHL databases were searched, including studies published up until 14(th) September 2022. Studies in adults with LRRC reporting PROMS as a primary or secondary outcome measure were included. Data were extracted concerning the methodological quality of the reporting of PROMs using criteria informed by the CONSORT-PRO checklist and the psychometric properties of the PROMs identified using the COSMIN Risk of Bias checklist. RESULTS: Thirty-five studies including 1914 patients with LRRC were identified. None of the studies included in the review met all eleven criteria for the quality of reporting of PROMs. Seventeen PROMs and two clinician-reported outcome measures were identified, none of which have been validated for use in patients with LRRC. CONCLUSIONS: None of the PROMs which are currently being used to report PROs in LRRC have been validated for use in this cohort of patients. Future studies in this disease area should focus on utilising PROMs that have undergone a robust development process including patients with LRRC, to produce data which is high quality, accurate and relevant.