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一项成本效用分析与一项评估社区药房小病服务与常规护理的集群随机试验同时进行。

A cost utility analysis alongside a cluster-randomised trial evaluating a minor ailment service compared to usual care in community pharmacy.

机构信息

Pharmaceutical Care Research Group, University of Granada, Campus de Cartuja, Granada, 18071, Spain.

Andalusian School of Public Health, Cuesta del Observatorio, Granada, 18080, Spain.

出版信息

BMC Health Serv Res. 2021 Nov 20;21(1):1253. doi: 10.1186/s12913-021-07188-4.

Abstract

BACKGROUND

Minor ailments are "self-limiting conditions which may be diagnosed and managed without a medical intervention". A cluster randomised controlled trial (cRCT) was designed to evaluate the clinical, humanistic and economic outcomes of a Minor Ailment Service (MAS) in community pharmacy (CP) compared with usual care (UC).

METHODS

The cRCT was conducted for 6 months from December 2017. The pharmacist-patient intervention consisted of a standardised face-to-face consultation on a web-based program using co-developed protocols, pharmacists' training, practice change facilitators and patients' educational material. Patients requesting a non-prescription medication (direct product request) or presenting minor ailments received MAS or UC and were followed-up by telephone 10-days after the consultation. The primary economic outcomes were incremental cost-utility ratio (ICUR) of the service and health related quality of life (HRQoL). Total costs included health system, CPs and patient direct costs: health professionals' consultation time, medication costs, pharmacists' training costs, investment of the pharmacy and consultation costs within the 10 days following the initial consultation. The HRQoL was obtained using the EuroQoL 5D-5L at the time of the consultation and at 10-days follow up. A sensitivity analysis was carried out using bootstrapping. There were two sub-group analyses undertaken, for symptom presentation and direct product requests, to evaluate possible differences.

RESULTS

A total of 808 patients (323 MAS and 485 UC) were recruited in 27 CPs with 42 pharmacists (20 MAS and 22 UC). 64.7% (n = 523) of patients responded to follow-up after their consultation in CP. MAS patients gained an additional 0.0003 QALYs (p = 0.053). When considering only MAS patients presenting with symptoms, the ICUR was 24,733€/QALY with a 47.4% probability of cost-effectiveness (willingness to pay of 25,000€/QALY). Although when considering patients presenting for a direct product request, MAS was the dominant strategy with a 93.69% probability of cost-effectiveness.

CONCLUSIONS

Expanding community pharmacists' scope through MAS may benefit health systems. To be fully cost effective, MAS should not only include consultations arising from symptom presentation but also include an oversight of self-selected products by patients. MAS increase patient safety through the appropriate use of non-prescription medication and through the direct referral of patients to GP.

TRIAL REGISTRATION

ISRCTN, ISRCTN17235323 . Registered 07/05/2021 - Retrospectively registered.

摘要

背景

小病是“无需医疗干预即可诊断和治疗的自限性疾病”。一项整群随机对照试验(cRCT)旨在评估社区药房(CP)中小病服务(MAS)与常规护理(UC)相比的临床、人文和经济结果。

方法

该 cRCT 于 2017 年 12 月进行了 6 个月。药剂师与患者的干预措施包括使用共同制定的协议在基于网络的程序上进行标准化的面对面咨询、药剂师培训、实践改变促进者和患者教育材料。要求非处方药(直接产品请求)或出现小病的患者接受 MAS 或 UC,并在咨询后 10 天通过电话进行随访。主要的经济结果是服务的增量成本效用比(ICUR)和与健康相关的生活质量(HRQoL)。总费用包括卫生系统、CP 和患者直接费用:卫生专业人员的咨询时间、药物费用、药剂师培训费用、药房投资以及初始咨询后 10 天内的咨询费用。在咨询时和 10 天随访时使用 EuroQoL 5D-5L 获得 HRQoL。进行了 bootstrap 敏感性分析。对于症状表现和直接产品请求进行了两次亚组分析,以评估可能的差异。

结果

共招募了 808 名患者(MAS 组 323 名,UC 组 485 名),27 家 CP 中有 42 名药剂师(MAS 组 20 名,UC 组 22 名)。在 CP 进行咨询后,64.7%(n=523)的患者对随访做出了回应。MAS 患者额外获得了 0.0003 个 QALYs(p=0.053)。当仅考虑出现症状的 MAS 患者时,ICUR 为 24,733€/QALY,成本效益的可能性为 47.4%(意愿支付 25,000€/QALY)。尽管当考虑因直接产品请求就诊的患者时,MAS 是一种主导策略,其成本效益的可能性为 93.69%。

结论

通过 MAS 扩大社区药剂师的服务范围可能对卫生系统有益。为了具有完全的成本效益,MAS 不仅应包括因症状表现而产生的咨询,还应包括对患者自选产品的监督。MAS 通过非处方药的正确使用以及直接将患者转介给全科医生来提高患者的安全性。

试验注册

ISRCTN,ISRCTN8463545。注册于 2021 年 7 月 5 日-回溯性注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b362/8605551/3d32309cd023/12913_2021_7188_Fig1_HTML.jpg

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