Task shifting of antiretroviral treatment from doctors to primary-care nurses in South Africa (STRETCH): a pragmatic, parallel, cluster-randomised trial.
Task shifting of antiretroviral treatment from doctors to primary-care nurses in South Africa (STRETCH): a pragmatic, parallel, cluster-randomised trial.
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DOI：
10.1016/s0140-6736(12)60730-2
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发表时间：
2012-09-08
期刊：
影响因子：
168.9
通讯作者：
Bateman, Eric
中科院分区：
文献类型：
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作者：
Fairall, Lara;Bachmann, Max O.;Lombard, Carl;Timmerman, Venessa;Uebel, Kerry;Zwarenstein, Merrick;Boulle, Andrew;Georgeu, Daniella;Colvin, Christopher J.;Lewin, Simon;Faris, Gill;Cornick, Ruth;Draper, Beverly;Tshabalala, Mvula;Kotze, Eduan;van Vuuren, Cloete;Steyn, Dewald;Chapman, Ronald;Bateman, Eric
将抗逆转录病毒治疗(ART)的任务从医生转移到其他卫生工作者的有效性的有力证据很少。我们的目标是评估精简任务和角色以扩大艾滋病毒治疗和护理(STREAD)方案对死亡率、病毒抑制和其他健康结果和质量指标的影响，该方案为护士提供教育外展培训，以启动和重新开出抗逆转录病毒药物，并分散护理。我们于2008年1月28日至2010年6月30日在南非进行了一项务实的、平行的整群随机试验。我们随机分配了31个初级保健ART诊所来实施伸展计划(干预组)或继续进行标准护理(对照组)。随机化的比例取决于九个阶层中每一个阶层有多少诊所。纳入了两个队列：队列1中符合条件的患者是CD4350个/≥/μL或更少的成年人(年龄16岁)，他们没有接受抗逆转录病毒治疗；队列2中的患者是已经接受抗逆转录病毒治疗至少6个月并在入选时接受治疗的成年人。队列1的主要结果是死亡时间(优势分析)。队列2的主要结果是登记12个月后病毒载量未被检测到的比例(每毫升400个拷贝)(等效性分析，预先指定的差异&6%)。患者和临床医生不能掩饰分组分配。中期分析是盲目的，但在数据库被锁定以进行最终分析后，数据分析师并未被掩盖。根据治疗意向进行分析。本次试验已注册，编号为ISRCTN46836853。干预组1组5390例，2组3029例；对照组1组3862例，2组3202例。队列1的中位随访期为16.3个月(IQR12.2~18.0)，队列2的中位随访期为18.0个月(18.0~18.0)。在队列1中，干预组分析的4943例患者中有997例(20%)死亡，而对照组3862例患者中有747例(19%)死亡。死亡时间无差异(危险比[HR]为0·94，95%CI为0·76-1·15)。在对基线CD4201-350个/μL的患者进行的预先计划的亚组分析中，干预组的死亡率略低于对照组(0.73，0.54-1.00；p=0.052)，但基线CD4200个/μL或更低的患者组之间的死亡率没有差异(0.94，0.76-1.15；p=0.577)。在队列2中，登记后12个月的病毒载量抑制与干预(3029名患者中的2156名[71%])和对照组(3202名患者中的2230名[70%]；风险差异1.1%，95%可信区间−2.4%至4.6%)相当。扩大初级保健护士的角色以包括抗逆转录病毒治疗的开始和重新开出处方是安全的，可以改善健康结果和护理质量，但可能不会减少接受抗逆转录病毒治疗的时间或死亡率。英国医学研究理事会、爱尔兰发展合作组织和加拿大国际开发署。
Robust evidence of the effectiveness of task shifting of antiretroviral therapy (ART) from doctors to other health workers is scarce. We aimed to assess the effects on mortality, viral suppression, and other health outcomes and quality indicators of the Streamlining Tasks and Roles to Expand Treatment and Care for HIV (STRETCH) programme, which provides educational outreach training of nurses to initiate and represcribe ART, and to decentralise care. We undertook a pragmatic, parallel, cluster-randomised trial in South Africa between Jan 28, 2008, and June 30, 2010. We randomly assigned 31 primary-care ART clinics to implement the STRETCH programme (intervention group) or to continue with standard care (control group). The ratio of randomisation depended on how many clinics were in each of nine strata. Two cohorts were enrolled: eligible patients in cohort 1 were adults (aged ≥16 years) with CD4 counts of 350 cells per μL or less who were not receiving ART; those in cohort 2 were adults who had already received ART for at least 6 months and were being treated at enrolment. The primary outcome in cohort 1 was time to death (superiority analysis). The primary outcome in cohort 2 was the proportion with undetectable viral loads (<400 copies per mL) 12 months after enrolment (equivalence analysis, prespecified difference <6%). Patients and clinicians could not be masked to group assignment. The interim analysis was blind, but data analysts were not masked after the database was locked for final analysis. Analyses were done by intention to treat. This trial is registered, number ISRCTN46836853. 5390 patients in cohort 1 and 3029 in cohort 2 were in the intervention group, and 3862 in cohort 1 and 3202 in cohort 2 were in the control group. Median follow-up was 16·3 months (IQR 12·2–18·0) in cohort 1 and 18·0 months (18·0–18·0) in cohort 2. In cohort 1, 997 (20%) of 4943 patients analysed in the intervention group and 747 (19%) of 3862 in the control group with known vital status at the end of the trial had died. Time to death did not differ (hazard ratio [HR] 0·94, 95% CI 0·76–1·15). In a preplanned subgroup analysis of patients with baseline CD4 counts of 201–350 cells per μL, mortality was slightly lower in the intervention group than in the control group (0·73, 0·54–1.00; p=0·052), but it did not differ between groups in patients with baseline CD4 of 200 cells per μL or less (0·94, 0·76–1·15; p=0·577). In cohort 2, viral load suppression 12 months after enrolment was equivalent in intervention (2156 [71%] of 3029 patients) and control groups (2230 [70%] of 3202; risk difference 1·1%, 95% CI −2·4 to 4·6). Expansion of primary-care nurses' roles to include ART initiation and represcription can be done safely, and improve health outcomes and quality of care, but might not reduce time to ART or mortality. UK Medical Research Council, Development Cooperation Ireland, and Canadian International Development Agency.