Feasibility of a new electronic patient-reported outcome (ePRO) system for an advanced therapy clinical trial in immune-mediated inflammatory disease (PROmics): protocol for a qualitative feasibility study.
Feasibility of a new electronic patient-reported outcome (ePRO) system for an advanced therapy clinical trial in immune-mediated inflammatory disease (PROmics): protocol for a qualitative feasibility study.
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DOI：
10.1136/bmjopen-2022-063199
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发表时间：
2022-09-06
期刊：
影响因子：
2.9
通讯作者：
中科院分区：
文献类型：
--
作者：
在临床试验中越来越多地使用电子患者报告结果 (ePRO) 系统来捕获 PRO 数据；然而，它们在先进治疗药品（ATMP）临床试验中的可行性、可接受性和实用性尚未得到充分了解。该协议描述了一项定性研究，旨在评估在一项涉及免疫介导炎症性疾病（类风湿性关节炎、狼疮、原发性硬化性胆管炎 (PSC) 和克罗恩病）患者的高级治疗试验中使用特定于试验的 ePRO 系统（PROmics 系统）进行 ePRO 数据采集的可行性和可接受性。该协议用于远程、定性、基于访谈的可行性研究，嵌入在英国的单臂、II 期、多站点 ATMP 篮子试验 POLARIZE 试验中。将招募 10-15 名参加 POLARIZE 试验的患者和试验地点的 10-15 名研究团队成员。参与者将参加半结构化访谈，访谈将逐字转录并根据框架方法进行主题分析。数据收集和分析将同时且迭代地进行。研究人员的三角测量将用于实现基于共识的分析，从而提高严谨性和可信度。这项研究得到了伦敦西伦敦和 GTAC 研究伦理委员会的批准（参考号：21/LO/0475）。在收集数据之前，将获得所有参与者的知情同意。研究结果将发表在同行评审期刊上，并通过会议演讲和其他媒体传播。我们将咨询我们的患者和公众参与小组以及 ATMP 利益相关者网络，以最大限度地提高传播和影响力。 ISRCTN80103507。
The use of electronic patient-reported outcome (ePRO) systems to capture PRO data in clinical trials is increasing; however, their feasibility, acceptability and utility in clinical trials of advanced therapy medicinal products (ATMPs) are not yet well understood. This protocol describes a qualitative study that aims to evaluate the feasibility and acceptability of ePRO data capture using a trial-specific ePRO system (the PROmics system) within an advanced therapy trial involving patients with immune-mediated inflammatory disease (rheumatoid arthritis, lupus, primary sclerosing cholangitis (PSC) and Crohn’s disease). This protocol for a remote, qualitative, interview-based feasibility study is embedded within the POLARISE trial, a single-arm, phase II, multisite ATMP basket trial in the UK. 10–15 patients enrolled in the POLARISE trial and 10–15 research team members at the trial sites will be recruited. Participants will take part in semistructured interviews which will be transcribed verbatim and analysed thematically according to the framework method. Data collection and analysis will occur concurrently and iteratively. Researcher triangulation will be used to achieve a consensus-based analysis, enhancing rigour and trustworthiness. This study was approved by the London—West London and GTAC Research Ethics Committee (Ref: 21/LO/0475). Informed consent will be obtained from all participants prior to data collection. The study findings will be published in peer-review journals and disseminated via conference presentations and other media. Our patient and public involvement and engagement group and ATMP stakeholder networks will be consulted to maximise dissemination and impact. ISRCTN80103507.
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影响因子：
28.4
作者：
Dueck AC;Mendoza TR;Mitchell SA;Reeve BB;Castro KM;Rogak LJ;Atkinson TM;Bennett AV;Denicoff AM;O'Mara AM;Li Y;Clauser SB;Bryant DM;Bearden JD 3rd;Gillis TA;Harness JK;Siegel RD;Paul DB;Cleeland CS;Schrag D;Sloan JA;Abernethy AP;Bruner DW;Minasian LM;Basch E;National Cancer Institute PRO-CTCAE Study Group
通讯作者：
National Cancer Institute PRO-CTCAE Study Group
影响因子：
4.5
作者：
Kluetz, Paul G.;Kanapuru, Bindu;Coons, Stephen Joel
通讯作者：
Coons, Stephen Joel
DOI：
10.14694/edbk_159514
发表时间：
2016-01-01
期刊：
American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting
影响因子：
--
作者：
Kluetz, Paul G;Chingos, Diana T;Mitchell, Sandra A
通讯作者：
Mitchell, Sandra A
影响因子：
3.5
作者：
Herdman, M.;Gudex, C.;Lloyd, A.;Janssen, M. F.;Kind, P.;Parkin, D.;Bonsel, G.;Badia, X.
通讯作者：
Badia, X.
影响因子：
4
作者：
Gale NK;Heath G;Cameron E;Rashid S;Redwood S
通讯作者：
Redwood S