Patient‐reported outcomes after pelvic exenteration for colorectal cancer: A systematic review

Abstract

Aim: Pelvic exenteration (PE) carries high morbidity. Our aim was to analyse the use of patient-reported outcome measures (PROMs) in PE patients. Method: Search strategies were protocolized and registered in PROSPERO. PubMed, Embase, Cochrane Library, Google Scholar, Web of Science and ClinicalTrials.gov were searched with the terms 'patient reported outcomes', 'pelvic exenteration' and 'colorectal cancer'. Studies published after 1980 reporting on PROMs for at least 10 PE patients were considered. Study selection, data extraction, rating of certainty of evidence (GRADE) and risk of bias (ROBINS-I) were performed independently by two reviewers. Results: Nineteen of 173 studies were included (13 retrospective, six prospective). All studies were low to very low quality, with an overall moderate/serious risk of bias. Studies included data on 878 patients with locally advanced rectal cancer (n = 344), recurrent rectal cancer (n = 411) or cancer of unknown type (n = 123). Thirteen studies used validated questionnaires, four used non-validated measures and two used both. Questionnaires included the Functional Assessment of Cancer Therapy-Colorectal questionnaire (n = 6), Short Form Health Survey (n = 6), European Organization for Research and Treatment for Cancer (EORTC) Quality of Life Questionnaire C30 (n = 6), EORTC-CR38 (n = 4), EORTC-BLM30 (n = 1), Brief Pain Inventory (n = 2), Short Form 12 (n = 1), Assessment of Quality of Life (n = 1), Short Form Six-Dimension (n = 1), the Memorial Sloan Kettering Cancer Center Sphincter Function Scale (n = 1), the Cleveland Global Quality of Life (n = 1) or other (n = 4). Timing varied between studies.Conclusions: Whilst the use of validated questionnaires increased over time, this study shows that there is a need for uniform use and timing of PROMs to enable multicentre studies.

Systematic Review of Patient-Reported Outcome Measures in Locally Recurrent Rectal Cancer

“…The most used PROMS in LRRC were the FACT-C (n = 10, 28.6%), SF-36 (n = 11, 31.4%) EORTC QLQ-C30 (n = 12, 34.3%) and CR29 (n = 8, 22.9%), none of which have demonstrated content validity specifically for patients with LRRC. Overall, the findings build on the existing evidence [16][17][18][19] of variable methodological quality of reporting of PROMs within small sample sizes and mixed disease cohorts. This review focuses specifically on the methodological quality of PRO reporting using criteria informed by the CONSORT-PRO checklist; common weaknesses were identified in several domains, including defining the PRO of interest, describing the statistical approach to missing data and stating PRO-specific limitations and implications for generalisability.…”

“…The existing evidence concerning PROs in LRRC possesses several limitations from a methodological standpoint, this includes heterogeneity in relation to the groups of patients included, with outcomes frequently reported in combined cohorts of patients with primary and recurrent disease, [16][17][18][19] and heterogeneity in comparator groups. In addition to significant variability in the PROMs used and timing of PROM assessment.…”

“…In addition to significant variability in the PROMs used and timing of PROM assessment. [16][17][18][19] The majority of existing studies are retrospective in nature 18 and the evidence is generally low in quality. [16][17][18][19][20] Denys et al's review focused on patientcentred outcomes following pelvic exenteration for colorectal cancer, including both primary and recurrent disease, also found that the impact of urinary complications, discomfort or pain on sitting and functional disability are inadequately represented in the PROMs currently being used.…”

“…[16][17][18][19] The majority of existing studies are retrospective in nature 18 and the evidence is generally low in quality. [16][17][18][19][20] Denys et al's review focused on patientcentred outcomes following pelvic exenteration for colorectal cancer, including both primary and recurrent disease, also found that the impact of urinary complications, discomfort or pain on sitting and functional disability are inadequately represented in the PROMs currently being used. 19 This review sought to evaluate the methodological quality of the existing evidence concerning PROs in LRRC, utilising a systematic approach.…”

“…[16][17][18][19][20] Denys et al's review focused on patientcentred outcomes following pelvic exenteration for colorectal cancer, including both primary and recurrent disease, also found that the impact of urinary complications, discomfort or pain on sitting and functional disability are inadequately represented in the PROMs currently being used. 19 This review sought to evaluate the methodological quality of the existing evidence concerning PROs in LRRC, utilising a systematic approach. The specific aims of the review were to identify the PROMs currently being used to report outcomes in patients with LRRC and to examine the methodological quality of the studies against criteria informed by the Consolidated Standards of Reporting Trials-Patient Reported Outcome (CONSORT-PRO) extension, 21,22 and the psychometric properties of the PROMs identified using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) Risk of Bias checklist.…”