“新药服务”:支持长期患者开始服用新药的依从性:一项实用随机对照试验的26周随访

Quality & Safety in Health Care Pub Date : 2020-04-01 Epub Date: 2019-11-15 DOI:10.1136/bmjqs-2018-009177
Rachel Ann Elliott, Matthew J Boyd, Lukasz Tanajewski, Nick Barber, Georgios Gkountouras, Anthony J Avery, Rajnikant Mehta, James E Davies, Nde-Eshimuni Salema, Christopher Craig, Asam Latif, Justin Waring, Antony Chuter
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引用次数: 0

摘要

目的探讨社区药学新药服务(NMS)在26周时的有效性和成本效益。方法在46家英国社区药店进行实用的患者水平平行随机对照试验。504名年龄≥14岁的参与者,在药房为预定义的长期疾病开具新药处方时被确认,随机接受NMS(n=251)或常规治疗(n=253)(NMS干预:在开具处方后1周和2周进行2次咨询)。在26周的随访中通过患者自我报告评估依从性。采用意向性治疗分析。国民健康服务(NHS)费用计算。疾病特异性马尔可夫模型估计不依从性的影响,结合临床试验数据计算每额外质量调整生命年的成本(QALY;英国国家医疗服务体系视角)。结果未经调整的分析:327例仍在服用初始药物的患者中,97/170例(57.1%)和103/157例(65.6%)(p=0.113)患者分别在常规和NMS组中有依从性。调整后的意向治疗分析:依从性OR 1.50(95%CI 0.93至2.44,p=0.095),有利于NMS。NMS的26周NHS费用没有显著降低:每位患者-104英镑(95%CI-37-257英镑,p=0.168)。NMS使每位患者的QALY平均增加0.04(95%CI−0.01至0.13),平均寿命成本减少113.9英镑(−1159.4683.7)。增量成本效益比为-2758英镑/QALY(2.5%和97.5%:-38739.534 024.2)。NMS有89%的成本效益概率,愿意为每个QALY支付20000英镑。结论在26周的随访中,NMS无法证明依从性的统计学显著增加或NHS成本的降低,这可能归因于研究中的患者流失。长期经济评估表明,NMS可能比正常做法提供更好的患者结果和更低的整体医疗成本,但这一发现的不确定性很高。试验注册号NCT01635361、ISRCTN23560818、ISRCTN23560818和UKCRN12494。
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'New Medicine Service': supporting adherence in people starting a new medication for a long-term condition: 26-week follow-up of a pragmatic randomised controlled trial.

Objective: To examine the effectiveness and cost-effectiveness of the community pharmacy New Medicine Service (NMS) at 26 weeks.

Methods: Pragmatic patient-level parallel randomised controlled trial in 46 English community pharmacies. 504 participants aged ≥14, identified in the pharmacy when presenting a prescription for a new medicine for predefined long-term conditions, randomised to receive NMS (n=251) or normal practice (n=253) (NMS intervention: 2 consultations 1 and 2 weeks after prescription presentation). Adherence assessed through patient self-report at 26-week follow-up. Intention-to-treat analysis employed. National Health Service (NHS) costs calculated. Disease-specific Markov models estimating impact of non-adherence combined with clinical trial data to calculate costs per extra quality-adjusted life-year (QALY; NHS England perspective).

Results: Unadjusted analysis: of 327 patients still taking the initial medicine, 97/170 (57.1%) and 103/157 (65.6%) (p=0.113) patients were adherent in normal practice and NMS arms, respectively. Adjusted intention-to-treat analysis: adherence OR 1.50 (95% CI 0.93 to 2.44, p=0.095), in favour of NMS. There was a non-significant reduction in 26-week NHS costs for NMS: -£104 (95% CI -£37 to £257, p=0.168) per patient. NMS generated a mean of 0.04 (95% CI -0.01 to 0.13) more QALYs per patient, with mean reduction in lifetime cost of -£113.9 (-1159.4, 683.7). The incremental cost-effectiveness ratio was -£2758/QALY (2.5% and 97.5%: -38 739.5, 34 024.2. NMS has an 89% probability of cost-effectiveness at a willingness to pay of £20 000 per QALY.

Conclusions: At 26-week follow-up, NMS was unable to demonstrate a statistically significant increase in adherence or reduction in NHS costs, which may be attributable to patient attrition from the study. Long-term economic evaluation suggested NMS may deliver better patient outcomes and reduced overall healthcare costs than normal practice, but uncertainty around this finding is high.

Trial registration number: NCT01635361, ISRCTN23560818, ISRCTN23560818, UKCRN12494.

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Quality & Safety in Health Care
Quality & Safety in Health Care 医学-卫生保健
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