用于肿瘤学临床研究和临床实践的乳腺癌患者报告结果测量指标（PROMs）综合档案：PRO4All 项目的成果。

IF 5.7 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Breast Pub Date : 2024-09-28 DOI:10.1016/j.breast.2024.103817

Anna Amela Valsecchi , Filippo Giovanardi , Francesco Malandrini , Michela Meregaglia , Alberto Servetto , Chiara Bennati , Carmine Pinto , Massimo Di Maio , Oriana Ciani

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引用次数: 0

摘要

背景：我们强烈建议在肿瘤临床试验中纳入患者报告结果 (PRO)。然而，选择最合适的患者报告结局指标（PROMs）并非易事。本研究旨在建立一个专门针对乳腺癌（BC）的综合患者报告结局指标档案库：作为 PRO4All 项目的一部分，我们通过搜索 facit.org、eortc.org、eprovide.mapi-trust.org、PubMed、ema.europa.eu（欧洲公共评估报告）和已发表的综述，确定了肿瘤学领域可用的 PROMs。本次分析仅提取了 BC 工具。我们描述了 PROM 名称、问卷类型、问卷变体、回收期、项目数量以及文献中是否存在最小临床重要差异 (MCID) 参考信息。然后，我们根据预定义的 38 个项目分类法将每个项目归入一个特定领域，以进行结果分类：我们确定并分析了 383 个 PROMs。结果：我们确定并分析了 383 个 PROMs，其中 29 个是针对 BC 的，但有 2 个因无法获得问卷描述而被排除在外。6份（22.2%）是其他问卷的变体。所有问卷均为自我报告。有 6 份问卷（22.2%）的回忆期为 "最近一周"。每份问卷的平均项目数为 25.81 个（6-71 个不等）。602 个项目被分配到一个结果领域：情绪功能/健康占 26.6%，身体功能占 14.1%，提供护理占 10.8%，一般结果占 10.5%。仅在 4 个病例（14.8%）中发现了 MCID 参考值：新开发的档案库是一种有用的工具，可优化 PROMs 在评估 BC 患者治疗中的应用，在临床研究和实践中推广以患者为中心的方法。

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Breast-cancer specific comprehensive archive of Patient-Reported Outcome Measures (PROMs) for clinical research and clinical practice in oncology: Results from the PRO4All project

Background

Inclusion of patient-reported outcomes (PROs) in oncology clinical trials is strongly recommended. However, selecting the most appropriate patient-reported outcome measures (PROMs) is not easy. This study aimed to develop a breast cancer (BC) specific comprehensive archive of PROMs.

Methods

As part of the PRO4All project, we identified available PROMs in oncology by searching facit.org, eortc.org, eprovide.mapi-trust.org, PubMed, ema.europa.eu (European Public Assessment Reports) and published reviews. For this analysis, only BC tools were extracted. We described information about PROM name, type of questionnaire, questionnaire variant(s), recall period, number of items, and presence of minimum clinically important difference (MCID) reference in literature. Then, we assigned each item to a specific domain according to a predefined taxonomy of 38 items for outcome classification.

Results

We identified and analyzed 383 PROMs. Of these, 29 were BC specific, but 2 were excluded because the questionnaires description was not available. 6 (22.2 %) were variants of another questionnaire. All questionnaires were self-reported. In 6 cases (22.2 %) the recall period to consider was the “last week”. The mean number of items per questionnaire was 25.81 (range 6–71). 602 items were assigned to an outcome domain: emotional functioning/wellbeing in 26.6 % of cases, physical functioning in 14.1 %, delivery of care in 10.8 %, and general outcomes in 10.5 %. MCID reference was found only in 4 (14.8 %) cases.

Conclusions

The newly developed archive represents a useful tool to optimize the use of PROMs in the evaluation of treatments in BC patients, promoting a patient-centered approach both in clinical research and practice.

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来源期刊

Breast 医学-妇产科学

CiteScore

8.70

自引率

2.60%

发文量

165

审稿时长

59 days

期刊介绍： The Breast is an international, multidisciplinary journal for researchers and clinicians, which focuses on translational and clinical research for the advancement of breast cancer prevention, diagnosis and treatment of all stages.