A core outcome set for localised prostate cancer effectiveness trials
A core outcome set for localised prostate cancer effectiveness trials
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DOI：
10.1111/bju.13854
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发表时间：
2017-11-01
影响因子：
4.5
通讯作者：
Lam, Thomas
中科院分区：
文献类型：
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作者：
MacLennan, Steven;Williamson, Paula R.;Lam, Thomas
目的建立一个适用于所有局限性前列腺癌干预措施有效性试验的核心结果集(COS)。对于局限性前列腺癌有许多治疗方法，尽管尚不清楚哪种疗法提供了最佳的治疗比率；临床试验中对结果的选择、定义、测量和报告的不一致令人困惑。患者、受试者和方法根据对已发表的局限性前列腺癌有效性研究的系统回顾和对15名前列腺癌患者的半结构化访谈得出79项结果清单。对118名患者和56名国际医疗保健专业人员(癌症专科护士、泌尿外科医生和肿瘤学家)进行了两阶段共识过程，包括三轮德尔菲调查，然后由13名癌症专家和8名患者参加面对面的共识小组会议。总共有12项适用于所有干预措施：前列腺癌死亡、任何原因死亡、局部疾病复发、远处疾病复发/转移、疾病进展、抢救治疗的需要、总体生活质量、压力性尿失禁、排尿功能、肠道功能、大便失禁和性功能。7个是特定于干预的：围手术期死亡(手术)、手术切缘阳性(手术)、血栓栓塞症(手术)、烦人的或有症状的尿道或吻合口狭窄(手术)、需要根治治疗(积极监测)、治疗失败(消融治疗)和激素治疗的副作用(激素治疗)。以英国为中心的参与者可能会将普遍性限制在其他国家，但试验者应该解释为什么COS不适用。默认的立场不应该是在一个国家开发的COS将自动不适用于其他国家。结论我们已经建立了局部前列腺癌有效性试验的COS，适用于所有局部前列腺癌有效性试验中应该衡量的所有干预措施。
ObjectiveTo develop a core outcome set (COS) applicable for effectiveness trials of all interventions for localised prostate cancer. Many treatments exist for localised prostate cancer, although it is unclear which offers the optimal therapeutic ratio; which is confounded by inconsistencies in the selection, definition, measurement and reporting of outcomes in clinical trials.Patients, Subjects and MethodsA list of 79 outcomes was derived from a systematic review of published localised prostate cancer effectiveness studies and semi-structured interviews with 15 patients with prostate cancer patients. A two-stage consensus process involving 118 patients and 56 international healthcare professionals (HCPs; cancer specialist nurses, urological surgeons and oncologists) was undertaken, consisting of a three-round Delphi survey followed by a face-to-face consensus panel meeting of 13 HCPs and eight patients.ResultsThe final COS included 19 outcomes. In all, 12 apply to all interventions: death from prostate cancer, death from any cause, local disease recurrence, distant disease recurrence/metastases, disease progression, need for salvage therapy, overall quality of life, stress urinary incontinence, urinary function, bowel function, faecal incontinence, and sexual function. Seven were intervention-specific: perioperative deaths (surgery), positive surgical margin (surgery), thromboembolic disease (surgery), bothersome or symptomatic urethral or anastomotic stricture (surgery), need for curative treatment (active surveillance), treatment failure (ablative therapy), and side-effects of hormonal therapy (hormone therapy). The UK-centric participants may limit the generalisability to other countries, but trialists should reason why the COS would not be applicable. The default position should not be that a COS developed in one country will automatically not be applicable elsewhere.ConclusionWe have established a COS for trials of effectiveness in localised prostate cancer, applicable across all interventions that should be measured in all localised prostate cancer effectiveness trials.