制定用于评估中医药治疗前列腺癌临床试验临床安全性结局的核心结局集：一项混合方法研究方案

Developing a Core Outcome Set for Assessing Clinical Safety Outcomes of Prostate Cancer in Clinical Trials of Traditional Chinese Medicine: Protocol for a Mixed Methods Study.

作者信息

Tian Huichuan, Zhang Yao, Ren Jiajun, Wang Chaoran, Mou Ruiyu, Li Xiaojiang, Jia Yingjie

机构信息

The First Affiliated Hospital of Tianjin University of Chinese Medicine, Tianjin, China.

National Clinical Research Center of Chinese Acupuncture and Moxibustion, Tianjin, China.

出版信息

JMIR Res Protoc. 2023 Aug 7;12:e46794. doi: 10.2196/46794.

DOI:10.2196/46794

PMID:37549007

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10442731/

Abstract

BACKGROUND

Among the common malignant tumors in men worldwide, the incidence of prostate cancer ranks second to lung cancer. This disease will bring an economic burden to patients and their families and can reduce the quality of life of patients. Researchers have conducted numerous clinical trials on the efficacy and safety of different interventions in the treatment of prostate cancer with traditional Chinese medicine (TCM) combined with standard treatment regimens. However, the currently published clinical trials exhibit inconsistent and irregular reporting of outcome measures.

OBJECTIVE

The objective of this paper is to emphasize the need for a core outcome set (COS) to facilitate future prostate cancer research, aiming to improve the quality of trials and generate high-quality evidence.

METHODS

This mixed methods project has three phases, as follows: (1) a scoping review of the literature to identify outcomes that have been reported in clinical trials and systematic reviews of interventions involving TCM for the treatment of prostate cancer as well as a qualitative component using interviews to obtain the views of patients with prostate cancer, their families, and their caregivers who have a history of TCM treatment; (2) a Delphi survey among stakeholders to prioritize the core outcomes-Participants will include traditional Chinese and Western medicine clinicians in prostate cancer-related directions, nurses, and methodology experts who will participate in 2 rounds of the Delphi method expert consultation to score each outcome in the list of outcome indicators; and (3) a face-to-face consensus meeting to discuss and agree on the final COS for the application of TCM in the treatment of prostate cancer.

RESULTS

The protocol has been registered in PROSPERO (CRD42022356184) before the start of the review process, and we will initiate the review on August 1, 2023; results should be expected by September 1, 2023. The Delphi survey among stakeholders is expected to start in October 2023.

CONCLUSIONS

The development of a core outcome set for assessing clinical safety outcomes of prostate cancer in clinical trials of TCM will provide a significant first step to assist Chinese doctors, researchers, and policy makers.

TRIAL REGISTRATION

PROSPERO CRD42022356184; https://tinyurl.com/ysakz74r.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/46794.

摘要

背景

在全球男性常见恶性肿瘤中，前列腺癌的发病率仅次于肺癌。这种疾病会给患者及其家庭带来经济负担，并会降低患者的生活质量。研究人员针对中医联合标准治疗方案在前列腺癌治疗中不同干预措施的疗效和安全性开展了大量临床试验。然而，目前已发表的临床试验在结局指标报告方面存在不一致和不规范的情况。

目的

本文旨在强调需要一个核心结局集（COS）来促进未来的前列腺癌研究，旨在提高试验质量并产生高质量证据。

方法

这个混合方法项目有三个阶段，具体如下：（1）对文献进行范围综述，以确定在涉及中医治疗前列腺癌的干预措施的临床试验和系统评价中报告的结局，以及使用访谈的定性部分，以获取有中医治疗史的前列腺癌患者、其家人及其护理人员的观点；（2）在利益相关者中进行德尔菲调查，以确定核心结局的优先级——参与者将包括前列腺癌相关领域的中西医临床医生、护士和方法学专家，他们将参与两轮德尔菲法专家咨询，对结局指标列表中的每个结局进行评分；（3）召开面对面共识会议，讨论并就中医治疗前列腺癌应用的最终核心结局集达成一致。