S7 File -

To undertake a mixed-methodology implementation study to improve the well-being of men with gastrointestinal late effects following radical radiotherapy for prostate cancer. All men completed a validated screening tool for late bowel effects (ALERT-B) and the Gastrointestinal Symptom Rating Score (GSRS); men with a positive score on ALERT-B were offered management following a peer reviewed algorithm for pelvic radiation disease (PRD). Health-related quality of life (HRQoL) at baseline, 6 and 12 months; and healthcare resource usage (HRU) and patient, support-giver, staff experience and acceptability of staff training (qualitative analysis) were assessed. Two nurse- and one doctor-led gastroenterology services were set up in three UK cancer centres. Men (n = 339) who had had radical radiotherapy for prostate cancer at least 6 months previously, were recruited; of which 91/339 were eligible to participate; 58/91 men (63.7%) accepted the referral. Diagnoses included: radiation proctopathy (n = 18); bile acid malabsorption (n = 15); fructose or lactose intolerance and/or small intestinal bacterial overgrowth (n = 20); vitamin B12/D deficiency (n = 20). Increases in quality of life, sexual activity and/or sexual function, and decrease in specific symptoms (e.g. bowel-related or urinary) between 6 and 12 months were observed. Limited HRU modelling suggested staff costs were £117-£185, depending on the service model; total costs averaged £2,243 per patient. Both staff and patients welcomed the new service although there was concern about long-term funding and sustainability beyond the timeframe of the study (qualitative). PRD is increasingly recognised worldwide as an ongoing consequence of curative pelvic radiotherapy, despite widespread implementation of advanced radiotherapy techniques. Specialised services following national guidelines are required.

本研究为一项混合方法学实施性研究，旨在改善前列腺癌根治性放疗后出现胃肠道远期不良反应男性的健康福祉。所有入组男性均完成了针对肠道远期不良反应的经验证筛查工具（ALERT-B）以及胃肠道症状评分量表（Gastrointestinal Symptom Rating Score, GSRS）；ALERT-B筛查结果阳性的男性，将按照针对盆腔放射疾病（pelvic radiation disease, PRD）的同行评议诊疗算法接受干预管理。
本研究评估了基线、6个月及12个月时的健康相关生命质量（Health-related quality of life, HRQoL）；同时评估了医疗资源消耗（healthcare resource usage, HRU）、患者、照护者及医护人员的体验，以及员工培训的可接受性（采用质性分析方法）。英国3家癌症中心分别设立了2项由护士主导、1项由医师主导的胃肠病诊疗服务。
研究共招募了339名此前至少6个月前接受过前列腺癌根治性放疗的男性；其中339人中的91人符合入组标准；91名符合条件者中有58人（占比63.7%）接受了转诊。最终诊断包括：放射性直肠病（n=18）、胆汁酸吸收不良（n=15）、果糖或乳糖不耐受及/或小肠细菌过度生长（n=20）、维生素B12/D缺乏症（n=20）。
研究观察到，在6个月至12个月期间，受试者的生命质量、性活动及/或性功能均有所提升，且特定症状（如肠道相关或泌尿系统相关症状）有所缓解。有限的医疗资源消耗模型分析显示，根据服务模式不同，医护人员成本为117至185英镑；每位患者的平均总成本为2243英镑。质性分析结果显示，医护人员与患者均对该新服务表示认可，但同时担忧研究周期之外的长期资金支持与服务可持续性问题。
尽管先进放疗技术已得到广泛应用，但盆腔放射疾病（PRD）作为根治性盆腔放疗的远期不良反应，已在全球范围内得到越来越多的认可。临床亟需建立遵循国家指南的专科诊疗服务。