Neilson Aileen R, Bruhn Hanne, Bond Christine M, Elliott Alison M, Smith Blair H, Hannaford Philip C, Holland Richard, Lee Amanda J, Watson Margaret, Wright David, McNamee Paul
Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.
Centre of Academic Primary Care, University of Aberdeen, Aberdeen, UK.
BMJ Open. 2015 Apr 1;5(4):e006874. doi: 10.1136/bmjopen-2014-006874.
To explore differences in mean costs (from a UK National Health Service perspective) and effects of pharmacist-led management of chronic pain in primary care evaluated in a pilot randomised controlled trial (RCT), and to estimate optimal sample size for a definitive RCT.
Regression analysis of costs and effects, using intention-to-treat and expected value of sample information analysis (EVSI).
Six general practices: Grampian (3); East Anglia (3).
125 patients with complete resource use and short form-six-dimension questionnaire (SF-6D) data at baseline, 3 months and 6 months.
Patients were randomised to either pharmacist medication review with face-to-face pharmacist prescribing or pharmacist medication review with feedback to general practitioner or treatment as usual (TAU).
Differences in mean total costs and effects measured as quality-adjusted life years (QALYs) at 6 months and EVSI for sample size calculation.
Unadjusted total mean costs per patient were £452 for prescribing (SD: £466), £570 for review (SD: £527) and £668 for TAU (SD: £1333). After controlling for baseline costs, the adjusted mean cost differences per patient relative to TAU were £77 for prescribing (95% CI -82 to 237) and £54 for review (95% CI -103 to 212). Unadjusted mean QALYs were 0.3213 for prescribing (SD: 0.0659), 0.3161 for review (SD: 0.0684) and 0.3079 for TAU (SD: 0.0606). Relative to TAU, the adjusted mean differences were 0.0069 for prescribing (95% CI -0.0091 to 0.0229) and 0.0097 for review (95% CI -0.0054 to 0.0248). The EVSI suggested the optimal future trial size was between 460 and 690, and between 540 and 780 patients per arm using a threshold of £30,000 and £20,000 per QALY gained, respectively.
Compared with TAU, pharmacist-led interventions for chronic pain appear more costly and provide similar QALYs. However, these estimates are imprecise due to the small size of the pilot trial. The EVSI indicates that a larger trial is necessary to obtain more precise estimates of differences in mean effects and costs between treatment groups.
ISRCTN06131530.
从英国国家医疗服务体系的角度探讨平均成本差异,以及在一项试点随机对照试验(RCT)中评估的初级保健中由药剂师主导的慢性疼痛管理的效果,并估计确定性RCT的最佳样本量。
使用意向性分析和样本信息期望值分析(EVSI)对成本和效果进行回归分析。
六个全科医疗诊所:格兰扁地区(3个);东安格利亚地区(3个)。
125名患者,在基线、3个月和6个月时拥有完整的资源使用情况和简式六维问卷(SF - 6D)数据。
患者被随机分为接受药剂师面对面开药的药物审查、接受药剂师向全科医生反馈的药物审查或常规治疗(TAU)。
6个月时以质量调整生命年(QALYs)衡量的平均总成本和效果差异,以及用于样本量计算的EVSI。
每位患者未调整的总平均成本,开药组为452英镑(标准差:466英镑),审查组为570英镑(标准差:527英镑),常规治疗组为668英镑(标准差:1333英镑)。在控制基线成本后,相对于常规治疗组,每位患者调整后的平均成本差异,开药组为77英镑(95%可信区间 - 82至237),审查组为54英镑(95%可信区间 - 103至212)。未调整的平均QALYs,开药组为0.3213(标准差:0.0659),审查组为0.3161(标准差:0.0684),常规治疗组为0.3079(标准差:0.0606)。相对于常规治疗组,调整后的平均差异,开药组为0.0069(95%可信区间 - 0.0091至0.0229),审查组为0.0097(95%可信区间 - 0.0054至0.0248)。EVSI表明,未来试验的最佳样本量在460至690之间,以及每组540至780名患者,分别使用每获得一个QALY 30,000英镑和20,000英镑的阈值。
与常规治疗相比,由药剂师主导的慢性疼痛干预措施似乎成本更高,且QALYs相似。然而,由于试点试验规模较小,这些估计并不精确。EVSI表明需要进行更大规模的试验,以更精确地估计治疗组之间平均效果和成本的差异。
ISRCTN06131530