Faculty Bibliography

IMPORTANCE/UNASSIGNED:Hypertension management has traditionally been based on office visits. Integrating remote monitoring into routine clinical practices and leveraging social support might improve blood pressure (BP) control. OBJECTIVE/UNASSIGNED:To evaluate the effectiveness of a bidirectional text monitoring program focused on BP control and medication adherence with and without social support in adults with hypertension. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This randomized clinical trial included adults aged 18 to 75 treated at an academic family medicine practice in Philadelphia in 2018 and 2019. Patients had been seen at least twice in the prior 24 months and had at least 2 elevated BP measurements (>150/90 mm Hg or >140/90 mm Hg for patients aged 18-59 years or with diabetes or chronic kidney disease) during visits. All participants had a cell phone with text messaging, offered at least 1 support partner, and were taking maintenance medications to treat hypertension. Patients were randomized 2:2:1 to remote monitoring of BP and medication adherence (RM), remote monitoring of BP and medication adherence with feedback provided to a social support partner (SS), or usual care (UC). Data were analyzed on an intention-to-treat basis between October 14, 2019, and May 30, 2020, and were revisited from May 23 through June 2, 2023. INTERVENTIONS/UNASSIGNED:The RM and SS groups received an automatic home BP monitor, 3 weekly texts requesting BP measurements, 1 weekly text inquiring about medication adherence, and a weekly text with feedback. In the SS arm, support partners received a weekly progress report. The UC group received UC through their primary care practice. Clinicians caring for the patients in the intervention groups received nudges via electronic health records to adjust medications when 3 of 10 reported BP measurements were elevated. Patients were followed up for 4 months. MAIN OUTCOMES AND MEASURES/UNASSIGNED:The primary outcome was systolic BP at 4 months measured during the final follow-up visit. Secondary outcomes included achievement of normotension and diastolic BP. RESULTS/UNASSIGNED:In all, 246 patients (mean [SD] age, 50.9 [11.4] years; 175 females [71.1%]; 223 Black individuals [90.7%] and 13 White individuals [5.3%]) were included in the intention-to-treat analysis: 100 patients in the RM arm, 97 in the SS arm, and 49 in the UC arm. Compared with the UC arm, there was no significant difference in systolic or diastolic BP at the 4-month follow-up visit in the RM arm (systolic BP adjusted mean difference, -5.25 [95% CI, -10.65 to 0.15] mm Hg; diastolic BP adjusted mean difference, -1.94 [95% CI, -5.14 to 1.27] mm Hg) or the SS arm (systolic BP adjusted mean difference, -0.91 [95% CI, -6.37 to 4.55] mm Hg; diastolic BP adjusted mean difference, -0.63 [95% CI, -3.77 to 2.51] mm Hg). Of the 206 patients with a final BP measurement at 4 months, BP was controlled in 49% (41 of 84) of patients in the RM arm, 31% (27 of 87) of patients in the SS arm, and 40% (14 of 35) of patients in the UC arm; these rates did not differ significantly between the intervention arms and the UC group. CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this randomized clinical trial, neither remote BP monitoring nor remote BP monitoring with social support improved BP control compared with UC in adults with hypertension. Additional efforts are needed to examine whether interventions directed at helping patients remember to take their BP medications can lead to improved BP control. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT03416283.

BACKGROUND:Colorectal cancer screening uptake in the United States overall has increased, but racial/ethnic disparities persist and data on colonoscopy uptake by racial/ethnic subgroups are lacking. We sought to better characterize these trends and to identify predictors of colonoscopy uptake, particularly among Asian and Hispanic subgroups. STUDY/METHODS:We used data from the New York City Community Health Survey to generate estimates of up-to-date colonoscopy use in Asian and Hispanic subgroups across 6 time periods spanning 2003-2016. For each subgroup, we calculated the percent change in colonoscopy uptake over the study period and the difference in uptake compared to non-Hispanic Whites in 2015-2016. We also used multivariable logistic regression to identify predictors of colonoscopy uptake. RESULTS:All racial and ethnic subgroups with reliable estimates saw a net increase in colonoscopy uptake between 2003 and 2016. In 2015-2016, compared with non-Hispanic Whites, Puerto Ricans, Dominicans, and Central/South Americans had higher colonoscopy uptake, whereas Chinese, Asian Indians, and Mexicans had lower uptake. On multivariable analysis, age, marital status, insurance status, primary care provider, receipt of flu vaccine, frequency of exercise, and smoking status were the most consistent predictors of colonoscopy uptake (≥4 time periods). CONCLUSIONS:We found significant variation in colonoscopy uptake among Asian and Hispanic subgroups. We also identified numerous demographic, socioeconomic, and health-related predictors of colonoscopy uptake. These findings highlight the importance of examining health disparities through the lens of disaggregated racial/ethnic subgroups and have the potential to inform future public health interventions.

BACKGROUND:There are no effective medical therapies for patients with meningioma who progress beyond surgical and radiotherapeutic interventions. Somatostatin receptor Type 2 (SSTR2) represents a promising treatment target in meningiomas. In this multicenter, single-arm phase II clinical study (NCT03971461), the SSTR2-targeting radiopharmaceutical 177Lu-DOTATATE is evaluated for its feasibility, safety, and therapeutic efficacy in these patients. PATIENTS AND METHODS/METHODS:Adult patients with progressive intracranial meningiomas received 177Lu-DOTATATE at a dose of 7.4 GBq (200 mCi) every eight weeks for four cycles. 68Ga-DOTATATE PET-MRI was performed before and six months after begin of treatment. The primary endpoint was progression-free survival (PFS) at 6 months (PFS-6). Secondary endpoints were safety and tolerability, overall survival (OS) at 12 months (OS-12), median PFS, and median OS. RESULTS:Fourteen patients (F=11, M=3) with progressive meningiomas (WHO 1=3, 2=10, 3=1) were enrolled. Median age was 63.1 (range 49.7-78) years. All patients previously underwent tumor resection and at least one course of radiation. Treatment with 177Lu-DOTATATE was well tolerated. Seven patients (50%) achieved PFS-6. Best radiographic response by modified Macdonald criteria was stable disease (SD) in all seven patients. A >25% reduction in 68Ga-DOTATATE (PET) was observed in five meningiomas and two patients. In one lesion, this corresponded to >50% reduction in bidirectional tumor measurements (MRI). CONCLUSIONS:Treatment with 177Lu-DOTATATE was well tolerated. The predefined PFS-6 threshold was met in this interim analysis, thereby allowing this multicenter clinical trial to continue enrollment. 68Ga-DOTATATE PET may be a useful imaging biomarker to assess therapeutic outcome in patients with meningioma.

Randomized controlled trials are the gold standard of clinical research for comparing therapies in well-defined groups of participants.¹ Randomization avoids confounding due to unmeasured variables or to treatment selection and enables a causal interpretation of the estimated treatment effect. It has long been recognized, however, that standard explanatory clinical trials are slow, costly, and subject to participant selection. To preserve the strengths of randomized trials while mitigating their weaknesses, pragmatic randomized clinical trials emerged; these trials aim to facilitate decision-making rather than explicate a mechanism of action and enroll a diverse set of participants using existing structures and data sources.².

IMPORTANCE/OBJECTIVE:SARS-CoV-2 infection can result in ongoing, relapsing, or new symptoms or organ dysfunction after the acute phase of infection, termed Post-Acute Sequelae of SARS-CoV-2 (PASC), or long COVID. The characteristics, prevalence, trajectory and mechanisms of PASC are poorly understood. The objectives of the Researching COVID to Enhance Recovery (RECOVER) tissue pathology study (RECOVER-Pathology) are to: (1) characterize prevalence and types of organ injury/disease and pathology occurring with PASC; (2) characterize the association of pathologic findings with clinical and other characteristics; (3) define the pathophysiology and mechanisms of PASC, and possible mediation via viral persistence; and (4) establish a post-mortem tissue biobank and post-mortem brain imaging biorepository. METHODS:RECOVER-Pathology is a cross-sectional study of decedents dying at least 15 days following initial SARS-CoV-2 infection. Eligible decedents must meet WHO criteria for suspected, probable, or confirmed infection and must be aged 18 years or more at the time of death. Enrollment occurs at 7 sites in four U.S. states and Washington, DC. Comprehensive autopsies are conducted according to a standardized protocol within 24 hours of death; tissue samples are sent to the PASC Biorepository for later analyses. Data on clinical history are collected from the medical records and/or next of kin. The primary study outcomes include an array of pathologic features organized by organ system. Causal inference methods will be employed to investigate associations between risk factors and pathologic outcomes. DISCUSSION/CONCLUSIONS:RECOVER-Pathology is the largest autopsy study addressing PASC among US adults. Results of this study are intended to elucidate mechanisms of organ injury and disease and enhance our understanding of the pathophysiology of PASC.

BACKGROUD/UNASSIGNED:Psoriatic arthritis (PsA) is a chronic, inflammatory arthritis that, when left untreated, can lead to erosions, deformities and decrease in quality of life. PsA is known to be associated with multiple comorbidities, including cardiovascular, metabolic and mental health syndromes, all of which can increase its overall morbidity and mortality. OBJECTIVE/UNASSIGNED:To characterize a cohort of patients with PsA and understand the impact of depression on PsA outcome measures. METHODS/UNASSIGNED:527 consecutive patients with PsA were enrolled in an observational, longitudinal registry that followed them prospectively at standard of care visits. Demographics, medical history, medication use, and clinical exam were all recorded. RESULTS/UNASSIGNED:Depression was reported in 22.8% of the population, anxiety in 18%, and attention deficit hyperactivity disorder in 4%. Depression was more common in female participants (P < .001). At baseline, individuals with PsA and concomitant depression had similar tender and swollen joint counts and RAPID3 compared to those without depression, and had lower body surface area affected by psoriasis (P = .04). At year one, all patients had improvement in clinical outcomes. However, patients with depression had a significantly higher tender joint count compared to those without depression (P = .001), despite similar swollen joint count and body surface area. CONCLUSION/UNASSIGNED:In patients with depression, there is a discrepancy between improvement in physician assessed measures and patient reported outcomes. These observations underscore the importance of addressing depression and psychological distress as part of PsA treatment outcomes and points towards the need to address residual pain through co-adjuvant approaches.

BACKGROUND:Heart failure (HF) is one of the most common reasons for hospital admission and is a major cause of morbidity, mortality, and increasing health care costs. The EMPOWER study was a randomized trial that used remote monitoring technology to track patients' weight and diuretic adherence and a state-of-the-art approach derived from behavioral economics to motivate adherence to the reverse monitoring technology. OBJECTIVE:The goal was to explore patient and clinician perceptions of the program and its impact on perceived health outcomes and better understand why some patients or clinicians did better or worse than others in response to the intervention. APPROACH:This was a retrospective qualitative study utilizing semi-structured interviews with 43 patients and 16 clinicians to understand the trial's processes, reflecting on successes and areas for improvement for future iterations of behavioral economic interventions. KEY RESULTS:Many patients felt supported, and they appreciated the intervention. Many also appreciated the lottery intervention, and while it was not an incentive for enrolling for many respondents, it may have increased adherence during the study. Clinicians felt that the intervention integrated well into their workflow, but the number of alerts was burdensome. Additionally, responses to alerts varied considerably by provider, perhaps because there are no professional guidelines for alerts unaccompanied by severe symptoms. CONCLUSION:Our qualitative analysis indicates potential areas for additional exploration and consideration to design better behavioral economic interventions to improve cardiovascular health outcomes for patients with HF. Patients appreciated lottery incentives for adhering to program requirements; however, many were too far along in their disease progression to benefit from the intervention. Clinicians found the amount and frequency of electronic alerts burdensome and felt they did not improve patient outcomes. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02708654.

PURPOSE/OBJECTIVE:Cancer and its treatments accelerate biological aging. This analysis tested the hypothesis that exercise and diet reduce oxidative stress and prevent telomere shortening in breast cancer survivors. METHODS:) and lymphocyte telomere length. RESULTS:did not correlate with change in telomere length (r = 0.07; 95% CI - 0.07, 0.20). CONCLUSION/CONCLUSIONS:In breast cancer survivors, diet alone or exercise plus diet were associated with reduced oxidative stress but did not change telomere length. This analysis may inform future trials that aim to optimize healthy aging in cancer survivors.