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低危基底细胞癌手术切除从二级医疗向初级医疗替代的多中心随机临床试验的过程评价。

Process evaluation of a multicentre randomised clinical trial of substituting surgical excisions of low-risk basal cell carcinomas from secondary to primary care.

机构信息

Dermatology, Erasmus MC Rotterdam, Rotterdam, The Netherlands.

General Practice, Erasmus MC Rotterdam, Rotterdam, The Netherlands.

出版信息

BMJ Open. 2022 Feb 23;12(2):e047745. doi: 10.1136/bmjopen-2020-047745.

DOI:10.1136/bmjopen-2020-047745
PMID:35197331
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8867327/
Abstract

OBJECTIVES

In 2016, the SKINCATCH Trial, a clustered multi-centre randomised trial, was initiated to assess whether low-risk basal cell carcinomas (BCCs) can be treated by general practitioners (GPs) without loss of quality of care. The trial intervention consisted of a tailored 2-day educational course on skin cancer management. The aim of this process evaluation was to investigate GPs' exposure to the intervention, implementation of the intervention and experiences with the intervention and trial.

RESEARCH DESIGN AND METHODS

Data on exposure to the intervention, implementation and experiences were obtained at several points during the trial. Complementary quantitative components (ie, surveys, database analysis, medical record analysis) and qualitative components (ie, interviews and focus groups) were used. Quantitative data were analysed using descriptive statistics; qualitative data were summarised (barrier interviews) or audiorecorded, transcribed verbatim and thematically analysed using Atlas.Ti (focus groups).

RESULTS

Following a 100% intervention exposure, results concerning the implementation of the trial showed that aside from the low inclusion rate of patients with low-risk BCCs (n=54), even less excisions of low-risk BCCs were performed (n=40). Although the intervention was experienced as highly positive, several barriers were mentioned regarding the trial including administrative challenges, lack of time and high workload of GPs, low volume of BCC patients and patients declining to participate or requesting a referral to a dermatologist.

CONCLUSIONS

Although GPs' participation in the highly valued training was optimal, several barriers may have contributed to the low inclusion and excision rate of low-risk BCCs. While some of the issues were trial-related, other barriers such as low patient-volume and patients requesting referrals are applicable outside the trial setting as well. This may question the feasibility of substitution of surgical excisions of low-risks BCCs from secondary to primary care in the current Dutch setting.

TRIAL REGISTRATION NUMBER

Trial NL5631 (NTR5746).

摘要

目的

2016 年,启动了 SKINCATCH 试验,这是一项集群多中心随机试验,旨在评估低危基底细胞癌(BCC)是否可以由全科医生(GP)治疗,而不会降低护理质量。该试验干预措施包括针对皮肤癌管理的为期 2 天的定制教育课程。本过程评估的目的是调查 GP 对干预措施的接触、干预措施的实施情况以及对干预措施和试验的经验。

研究设计和方法

在试验过程中的几个时间点收集了接触干预措施、实施情况和经验的数据。使用了补充的定量成分(即调查、数据库分析、病历分析)和定性成分(即访谈和焦点小组)。使用描述性统计方法分析定量数据;定性数据通过总结(障碍访谈)或录音、逐字转录和使用 Atlas.Ti(焦点小组)进行主题分析进行总结。

结果

在 100%的干预措施暴露后,关于试验实施的结果表明,除了低风险 BCC 患者的低纳入率(n=54)外,甚至更少地进行了低风险 BCC 的切除术(n=40)。尽管干预措施被认为非常积极,但在试验方面提到了几个障碍,包括行政挑战、GP 缺乏时间和高工作量、BCC 患者数量低以及患者拒绝参与或要求转诊至皮肤科医生。

结论

尽管 GP 对高度重视的培训的参与是最佳的,但一些障碍可能导致低风险 BCC 的低纳入和切除率。虽然一些问题与试验有关,但其他障碍,如患者数量低和患者要求转诊,不仅在试验环境中适用,而且在其他环境中也适用。这可能质疑在当前荷兰环境中,将低风险 BCC 的手术切除从二级医疗转移到初级保健的可行性。

试验注册号

NL5631(NTR5746)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4697/8867327/96060ee76747/bmjopen-2020-047745f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4697/8867327/aa8612b09508/bmjopen-2020-047745f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4697/8867327/96060ee76747/bmjopen-2020-047745f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4697/8867327/aa8612b09508/bmjopen-2020-047745f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4697/8867327/96060ee76747/bmjopen-2020-047745f02.jpg

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本文引用的文献

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PLoS One. 2019 Mar 19;14(3):e0213595. doi: 10.1371/journal.pone.0213595. eCollection 2019.
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由于患者招募未成功,一项全科医学随机对照试验提前终止。
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