HealthPartners Institute, Mailstop 21112R, PO Box 1524, Minneapolis, MN, 55440-1524, USA.
Kaiser Permanente Washington Health Research Institute, 1730 Minor Av, Seattle, WA, 98101, USA.
Trials. 2022 Aug 17;23(1):673. doi: 10.1186/s13063-022-06611-3.
Explanatory trials are designed to assess intervention efficacy under ideal conditions, while pragmatic trials are designed to assess whether research-proven interventions are effective in "real-world" settings without substantial research support.
We compared two trials (Hyperlink 1 and 3) that tested a pharmacist-led telehealth intervention in adults with uncontrolled hypertension. We applied PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) scores to describe differences in the way these studies were designed and enrolled study-eligible participants, and the effect of these differences on participant characteristics and adherence to study interventions.
PRECIS-2 scores demonstrated that Hyperlink 1 was more explanatory and Hyperlink 3 more pragmatic. Recruitment for Hyperlink 1 was conducted by study staff, and 2.9% of potentially eligible patients enrolled. Enrollees were older, and more likely to be male and White than non-enrollees. Study staff scheduled the initial pharmacist visit and adherence to attending this visit was 98%. Conversely for Hyperlink 3, recruitment was conducted by clinic staff at routine encounters and 81% of eligible patients enrolled. Enrollees were younger, and less likely to be male and White than non-enrollees. Study staff did not assist with scheduling the initial pharmacist visit and adherence to attending this visit was only 27%. Compared to Hyperlink 1, patients in Hyperlink 3 were more likely to be female, and Asian or Black, had lower socioeconomic indicators, and were more likely to have comorbidities. Owing to a lower BP for eligibility in Hyperlink 1 (>140/90 mm Hg) than in Hyperlink 3 (>150/95 mm Hg), mean baseline BP was 148/85 mm Hg in Hyperlink 1 and 158/92 mm Hg in Hyperlink 3.
The pragmatic design features of Hyperlink 3 substantially increased enrollment of study-eligible patients and of those traditionally under-represented in clinical trials (women, minorities, and patients with less education and lower income), and demonstrated that identification and enrollment of a high proportion of study-eligible subjects could be done by usual primary care clinic staff. However, the trade-off was much lower adherence to the telehealth intervention than in Hyperlink 1, which is likely to reflect uptake under real-word conditions and substantially dilute intervention effect on BP.
The Hyperlink 1 study (NCT00781365) and the Hyperlink 3 study (NCT02996565) are registered at ClinicalTrials.gov.
解释性试验旨在评估干预措施在理想条件下的疗效，而实用性试验旨在评估已证明有效的研究干预措施在没有大量研究支持的“真实世界”环境中的有效性。
我们比较了两项试验（超链接 1 和 3），这些试验测试了一种由药剂师主导的远程医疗干预措施，用于治疗未得到控制的高血压成年人。我们应用 PRagmatic Explanatory Continuum Indicator Summary-2（PRECIS-2）评分来描述这些研究在设计和招募研究合格参与者方面的差异，以及这些差异对参与者特征和对研究干预措施的依从性的影响。
PRECIS-2 评分表明，超链接 1 更具解释性，超链接 3 更具实用性。超链接 1 的招募工作由研究人员进行，有 2.9%的潜在合格患者入组。入组患者年龄较大，且男性和白人的比例高于非入组患者。研究人员安排了首次药剂师就诊，参加该就诊的依从性为 98%。相比之下，超链接 3 的招募工作由诊所工作人员在常规就诊时进行，有 81%的合格患者入组。入组患者年龄较小，且男性和白人的比例低于非入组患者。研究人员没有协助安排首次药剂师就诊，参加该就诊的依从性仅为 27%。与超链接 1 相比，超链接 3 中的患者更有可能是女性、亚洲人或黑人，社会经济指标较低，且更有可能患有合并症。由于超链接 1 的入选血压标准较高（>140/90mmHg），而超链接 3 的入选血压标准较高（>150/95mmHg），因此超链接 1 的基线血压平均值为 148/85mmHg，超链接 3 的基线血压平均值为 158/92mmHg。
超链接 3 的实用性设计特征显著增加了研究合格患者的入组率，以及那些在临床试验中代表性不足的患者（女性、少数族裔和受教育程度和收入较低的患者）的入组率，并表明可以由常规初级保健诊所工作人员确定并招募很大比例的研究合格患者。然而，与超链接 1 相比，该方法对远程医疗干预措施的依从性要低得多，这可能反映了实际情况下的采用情况，并大大稀释了干预措施对血压的影响。
超链接 1 研究（NCT00781365）和超链接 3 研究（NCT02996565）均在 ClinicalTrials.gov 注册。
