Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Princess Alexandra Hospital, Brisbane, Australia.
Ann Surg Oncol. 2023 Jul;30(7):3969-3986. doi: 10.1245/s10434-023-13388-5. Epub 2023 Apr 18.
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.
PubMed, Embase and CINAHL databases were searched, including studies published up until 14 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.
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.
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.
高质量的患者报告结局（PRO）数据对于指导局部复发性直肠癌（LRRC）的共同决策至关重要，在这种情况下，必须权衡疾病和治疗对 PRO 的影响，如生活质量，以平衡潜在的治疗获益。本研究旨在确定目前在 LRRC 中报告的患者报告结局测量指标（PROM），并评估使用这些指标的研究的方法学质量。
检索了 PubMed、Embase 和 CINAHL 数据库，包括截至 2022 年 9 月 14 日发表的研究。纳入了报告 LRRC 主要或次要结局的成人使用 PROM 的研究。使用 CONSORT-PRO 清单中规定的标准和 COSMIN 偏倚风险清单中确定的 PROM 的心理测量特性，提取关于 PROM 报告方法学质量的数据。
共确定了 35 项研究，包括 1914 例 LRRC 患者。本综述中纳入的研究均未满足 PROM 报告质量的 11 项标准。确定了 17 种 PROM 和 2 种临床医生报告的结局测量指标，均未在 LRRC 患者中进行验证。
目前用于报告 LRRC 患者 PRO 的 PROM 均未在该患者人群中进行验证。未来在该疾病领域的研究应重点关注使用经过患者参与的严格开发过程验证的 PROM，以生成高质量、准确和相关的数据。
