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一项初级保健中务实的多中心试点随机对照试验(RCT)的过程评估:药剂师和顾问医师针对慢性阻塞性肺疾病(COPD)及其合并症的定制干预(TICC PCP)

Process evaluation of a pragmatic, multicentre pilot Randomised Controlled Trial (RCT) in primary care: Tailored intervention for COPD and Co-morbidities by Pharmacists and Consultant Physicians (TICC PCP).

作者信息

Wood Karen, Lowrie Richard, Smith Georgia, Anderson David, Moir Jane, Attwood Lynda, McPherson Andrew, Sheikh Aziz, Rankine Elaine, Mair Frances S

机构信息

School of Health and Wellbeing, College of Medical, Veterinary and Life Sciences, The University of Glasgow, Scotland, United Kingdom.

Centre for Homelessness and Inclusion Health, School of Health in Social Science, The University of Edinburgh, Scotland, United Kingdom.

出版信息

PLoS One. 2025 Jun 30;20(6):e0326178. doi: 10.1371/journal.pone.0326178. eCollection 2025.

DOI:10.1371/journal.pone.0326178
PMID:40587568
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12208426/
Abstract

Chronic Obstructive Pulmonary Disease (COPD) is a growing global challenge. We undertook a process evaluation embedded within the Tailored Intervention at home for patients with moderate-to-severe COPD and Co-Morbidities by Pharmacists and Consultant Physicians (TICC PCP) pilot randomised controlled trial (RCT), which explored patient/stakeholder perceptions of the intervention, acceptability of trial procedures, and barriers/facilitators to intervention implementation. Semi-structured telephone interviews were conducted with intervention patients (20) and stakeholders (10); data were analysed thematically, conceptualised through Normalisation Process Theory. Patient perspectives compared based on socio-economic status (SES). Patients/stakeholders reported positive perceptions of the intervention/trial procedures. Pharmacists provided support across a range of health/social issues. Challenges related to: recruitment; workload/lone-working; managing patient complexity; and data collection. There were suggestions Pharmacists were able to undertake more actions to support patients from low SES areas. Overall, intervention and trial procedures were acceptable to patients and stakeholders. Findings support progression to full-scale RCT.

摘要

慢性阻塞性肺疾病(COPD)是一个日益严峻的全球性挑战。我们在药剂师和顾问医师针对中重度慢性阻塞性肺疾病及合并症患者的居家定制干预(TICC PCP)试点随机对照试验(RCT)中进行了一项过程评估,该评估探讨了患者/利益相关者对干预措施的看法、试验程序的可接受性以及干预实施的障碍/促进因素。我们对20名干预患者和10名利益相关者进行了半结构化电话访谈;对数据进行了主题分析,并通过规范化过程理论进行概念化。基于社会经济地位(SES)对患者的观点进行了比较。患者/利益相关者对干预措施/试验程序给予了积极评价。药剂师在一系列健康/社会问题上提供了支持。挑战涉及:招募;工作量/独自工作;管理患者复杂性;以及数据收集。有人建议药剂师能够采取更多行动来支持来自低社会经济地位地区的患者。总体而言,干预措施和试验程序为患者和利益相关者所接受。研究结果支持推进至全面的随机对照试验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/89c2/12208426/8afa4cc2d539/pone.0326178.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/89c2/12208426/8d0e2d4dab69/pone.0326178.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/89c2/12208426/8afa4cc2d539/pone.0326178.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/89c2/12208426/8d0e2d4dab69/pone.0326178.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/89c2/12208426/8afa4cc2d539/pone.0326178.g002.jpg

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