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Background 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. Methods 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. Results 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. Conclusion 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. Trial registration The Hyperlink 1 study (NCT00781365) and the Hyperlink 3 study (NCT02996565) are registered at ClinicalTrials.gov.

Background Patient reported outcome measures (PROMs) are increasingly being incorporated into clinical and surgical care for assessing outcomes. This study examined outcomes important to patients in their decision to have hip or knee replacement surgery, their perspectives on PROMs and shared decision-making, and factors they considered important for postoperative care. Methods A cross-sectional study employing survey methods with a stratified random sample of adult orthopedic patients who were scheduled for or recently had hip or knee replacement surgery. Results In a representative sample of 226 respondents, patients identified personalized outcomes important to them that they wanted from their surgery including the ability to walk without pain/discomfort, pain relief, and returning to an active lifestyle. They preferred a personalized outcome (54%) that they identified, compared to a PROM score, for tracking progress in their care and thought it important that their surgeon know their personal outcomes (63%). Patients also wanted to engage in shared decision-making (79%) about their post-surgical care and identified personal factors important to their aftercare, such as living alone and caring for pets. Conclusions Patients identified unique personalized outcomes they desired from their care and that they wanted their orthopedic surgeons to know about. Asking patients to identify their personalized outcomes could add value for both patients and surgeons in clinical care, facilitating more robust patient involvement in shared decision-making.