OBJECTIVE To evaluate the effectiveness and cost effectiveness of a complex intervention in primary care that aims to increase uptake of hepatitis C virus (HCV) case finding and treatment. DESIGN Pragmatic, two armed, practice level, cluster randomised controlled trial and economic evaluation. SETTING AND PARTICIPANTS 45 general practices in South West England (22 randomised to intervention and 23 to control arm). Outcome data were collected from all intervention practices and 21/23 control practices. Total number of flagged patients was 24 473 (about 5% of practice list). INTERVENTION Electronic algorithm and flag on practice systems identifying patients with HCV risk markers (such as history of opioid dependence or HCV tests with no evidence of referral to hepatology), staff educational training in HCV, and practice posters/leaflets to increase patients' awareness. Flagged patients were invited by letter for an HCV test (with one follow-up) and had on-screen pop-ups to encourage opportunistic testing. The intervention lasted one year, with practices recruited April to December 2016. MAIN OUTCOME MEASURES Primary outcome: uptake of HCV testing. SECONDARY OUTCOMES number of positive HCV tests and yield (proportion HCV positive); HCV treatment assessment at hepatology; cost effectiveness. RESULTS Baseline HCV testing of flagged patients (six months before study start) was 608/13 097 (4.6%) in intervention practices and 380/11 376 (3.3%) in control practices. During the study 2071 (16%) of flagged patients in the intervention practices and 1163 (10%) in control practices were tested for HCV: overall intervention effect as an adjusted rate ratio of 1.59 (95% confidence interval 1.21 to 2.08; P<0.001). HCV antibodies were detected in 129 patients from intervention practices and 51 patients from control practices (adjusted rate ratio 2.24, 1.47 to 3.42) with weak evidence of an increase in yield (6.2% v 4.4%; adjusted risk ratio 1.40, 0.99 to 1.95). Referral and assessment increased in intervention practices compared with control practices (adjusted rate ratio 5.78, 1.6 to 21.6) with a risk difference of 1.3 per 1000 and a "number needed to help" of one extra HCV diagnosis, referral, and assessment per 792 (95% confidence interval 558 to 1883) patients flagged. The average cost of HCV case finding was £4.03 (95% confidence interval £2.27 to £5.80) per at risk patient and £3165 per additional patient assessed at hepatology. The incremental cost effectiveness ratio was £6212 per quality adjusted life year (QALY), with 92.5% probability of being below £20 000 per QALY. CONCLUSION HepCATT had a modest impact but is a low cost intervention that merits optimisation and implementation as part of an NHS strategy to increase HCV testing and treatment. TRIAL REGISTRATION ISRCTN61788850.

中文翻译：

---

增加丙型肝炎病毒检测和治疗（HepCATT）摄入量的干预措施的成本效益：基层医疗中的随机分组对照试验。

目的评估一项旨在增加丙型肝炎病毒（HCV）病例发现和治疗吸收率的复杂的初级保健干预措施的有效性和成本效益。设计务实，两级武装，实践水平，分组随机对照试验和经济评估。背景和参与者英格兰西南部的45种常规做法（22种随机分配给干预措施，23种随机分配给对照组）。从所有干预措施和21/23控制措施中收集结果数据。被标记患者的总数为24 473（约占执业名单的5％）。干预措施电子算法和实践系统中的标志物，用于识别具有HCV危险标志物的患者（例如阿片类药物依赖史或无肝病证据的HCV测试），员工进行HCV教育培训，并练习张贴海报/传单以提高患者的意识。受信邀请受邀患者进行HCV测试（进行一次随访），并在屏幕上弹出弹出窗口以鼓励进行机会性测试。干预持续了一年，从2016年4月至2016年12月进行了招募。主要观察指标主要结果：接受HCV检测。次要结果HCV阳性检测数量和产量（HCV阳性比例）；肝病HCV治疗评估；成本效益。结果干预实践中标记患者（研究开始前六个月）的基线HCV测试为608/13 097（4.6％），对照实践为380/11 376（3.3％）。在研究期间，对207例（16％）干预措施中被标记患者和1163例（10％）对照患者进行了HCV检测：总体干预效果为调整后的比率1.59（95％置信区间1.21至2.08； P <0.001）。在129名干预措施患者和51名对照措施患者中检测到HCV抗体（调整率比2.24、1.47至3.42），但收率升高的证据很微弱（6.2％对4.4％；调整后的风险比1.40、0.99至1.95）。 。干预措施的转诊和评估与控制措施（调整率比率5.78，1.6至21.6）相比有所增加，风险差异为每千人1.3，“需要帮助的数目”是每792例额外的HCV诊断，转诊和评估（“ 95％的置信区间558至1883）患者被标记。HCV病例发现的平均成本为每位高危患者4.03英镑（95％置信区间2.27至5.80英镑），每增加一名肝病患者评估3165英镑。每质量调整生命年（QALY）的成本效益增加比为6212英镑，每个QALY低于20000英镑的可能性为92.5％。结论HepCATT影响不大，但是一项低成本干预措施，值得优化和实施，这是NHS增加HCV检测和治疗策略的一部分。试用注册号ISRCTN61788850。