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Nadofaragene firadenovec is a gene therapy for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) undergoing FDA review. Pembrolizumab is approved for treating BCG-unresponsive NMIBC patients with carcinoma in-situ (CIS). We evaluated the cost-effectiveness of these treatments compared with a hypothetical therapeutic alternative, at a willingness-to-pay (WTP) threshold of $150,000 per quality-adjusted life year (QALY) gained, in CIS and non-CIS BCG-unresponsive NMIBC populations.We developed a Markov cohort simulation model with a three-month cycle length and lifetime horizon to estimate total costs, QALYs and cost per additional QALY from the health sector perspective. Clinical inputs were informed by results of single-arm clinical trials evaluating the treatments and systematic literature reviews were conducted to obtain other model inputs. Sensitivity analyses were conducted to assess uncertainty in model results.Nadofaragene firadenovec, at a placeholder price 10% higher than the price of pembrolizumab, had an incremental cost-effectiveness ratio (ICER) of $263,000 and $145,000 per QALY gained in CIS and non-CIS populations, respectively. Pembrolizumab had an ICER of $168,000 per QALY gained for CIS. A 5.4% reduction in pembrolizumab's price would make it cost-effective. The model was sensitive to many inputs, especially probabilities of disease progression, initial treatment response and durability, and drug price.The cost-effectiveness of nadofaragene firadenovec will depend upon its price. Pembrolizumab, though not cost-effective in our base-case analysis, is an important alternative in this population with an unmet medical need. Comparative trials of these treatments are warranted to better estimate cost-effectiveness.

In 2018, the US Preventive Services Task Force endorsed primary human papillomavirus testing (pHPV) for cervical cancer screening. We aimed to describe providers’ beliefs about pHPV testing effectiveness and which screening approach they regularly recommend. We invited providers who performed 10 or more cervical cancer screens in 2019 in 3 healthcare systems that had not adopted pHPV testing: Kaiser Permanente Washington, Mass General Brigham, and Parkland Health; 53.7% (501/933) completed the survey between October and December 2020. Response distributions varied across modalities (P

ImportanceHealth care systems focus on delivering routine cancer screening to eligible individuals, yet little is known about the perceptions of primary care practitioners (PCPs) about barriers to timely follow-up of abnormal results.ObjectiveTo describe PCP perceptions about factors associated with the follow-up of abnormal breast, cervical, colorectal, and lung cancer screening test results.Design, Setting, and ParticipantsSurvey study of PCPs from 3 primary care practice networks in New England between February and October 2020, prior to participating in a randomized clinical trial to improve follow-up of abnormal cancer screening test results. Participants were physicians and advanced practice clinicians from participating practices.Main Outcomes and MeasuresSelf-reported process, attitudes, knowledge, and satisfaction about the follow-up of abnormal cancer screening test results.ResultsOverall, 275 (56.7%) PCPs completed the survey (range by site, 34.9%-71.9%) with more female PCPs (61.8% [170 of 275]) and general internists (73.1% [201 of 275]); overall, 28,7% (79 of 275) were aged 40 to 49 years. Most PCPs felt responsible for managing abnormal cancer screening test results with the specific cancer type being the best factor (range, 63.6% [175 of 275] for breast to 81.1% [223 of 275] for lung; P Conclusions and RelevanceIn this survey study of PCPs, important deficiencies in systems for managing abnormal cancer screening test results were reported. These findings suggest a need for comprehensive organ-agnostic systems to promote timely follow-up of abnormal cancer screening results using a primary care–focused approach across the range of cancer screening tests.

Background: Morbidity from undiagnosed atrial fibrillation (AF) may be preventable with early detection. Many consumer wearables contain optical photoplethysmography (PPG) sensors to measure pulse rate. PPG-based software algorithms that detect irregular heart rhythms may identify undiagnosed AF in large populations using wearables, but minimizing false-positive detections is essential. Methods: We performed a prospective remote clinical trial to examine a novel PPG-based algorithm for detecting undiagnosed AF from a range of wrist-worn devices. Adults aged ≥22 years in the United States without AF, using compatible wearable Fitbit devices and Android or iOS smartphones, were included. PPG data were analyzed using a novel algorithm that examines overlapping 5-minute pulse windows (tachograms). Eligible participants with an irregular heart rhythm detection (IHRD), defined as 11 consecutive irregular tachograms, were invited to schedule a telehealth visit and were mailed a 1-week ambulatory ECG patch monitor. The primary outcome was the positive predictive value of the first IHRD during ECG patch monitoring for concurrent AF. Results: A total of 455 699 participants enrolled (median age 47 years, 71% female, 73% White) between May 6 and October 1, 2020. IHRDs occurred for 4728 (1%) participants, and 2070 (4%) participants aged ≥65 years during a median of 122 (interquartile range, 110–134) days at risk for an IHRD. Among 1057 participants with an IHRD notification and subsequent analyzable ECG patch monitor, AF was present in 340 (32.2%). Of the 225 participants with another IHRD during ECG patch monitoring, 221 had concurrent AF on the ECG and 4 did not, resulting in an IHRD positive predictive value of 98.2% (95% CI, 95.5%–99.5%). For participants aged ≥65 years, the IHRD positive predictive value was 97.0% (95% CI, 91.4%–99.4%). Conclusions: A novel PPG software algorithm for wearable Fitbit devices exhibited a high positive predictive value for concurrent AF and identified participants likely to have AF on subsequent ECG patch monitoring. Wearable devices may facilitate identifying individuals with undiagnosed AF. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04380415.

Background Early detection of atrial fibrillation or flutter (AF) may enable prevention of downstream morbidity. Consumer wrist-worn wearable technology is capable of detecting AF by identifying irregular pulse waveforms using photoplethysmography (PPG). The validity of PPG-based software algorithms for AF detection requires prospective assessment. Methods The Fitbit Heart Study (NCT04380415) is a single-arm remote clinical trial examining the validity of a novel PPG-based software algorithm for detecting AF. The proprietary Fitbit algorithm examines pulse waveform intervals during analyzable periods in which participants are sufficiently stationary. Fitbit consumers with compatible wrist-worn trackers or smartwatches were invited to participate. Enrollment began May 6, 2020 and as of October 1, 2020, 455,699 participants enrolled. Participants in whom an irregular heart rhythm was detected were invited to attend a telehealth visit and eligible participants were then mailed a one-week single lead electrocardiographic (ECG) patch monitor. The primary study objective is to assess the positive predictive value of an irregular heart rhythm detection for AF during the ECG patch monitor period. Additional objectives will examine the validity of irregular pulse tachograms during subsequent heart rhythm detections, self-reported AF diagnoses and treatments, and relations between irregular heart rhythm detections and AF episode duration and time spent in AF. Conclusions The Fitbit Heart Study is a large-scale remote clinical trial comprising a unique software algorithm for detection of AF. The study results will provide critical insights into the use of consumer wearable technology for AF detection, and for characterizing the nature of AF episodes detected using consumer-based PPG technology.

DISCLOSURES: Funding for this summary was contributed by Arnold Ventures, California Health Care Foundation, The Donaghue Foundation, Harvard Pilgrim Health Care, and Kaiser Foundation Health Plan to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from AbbVie, Aetna, America's Health Insurance Plans, Anthem, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Boehringer-Ingelheim, Cambia Health Services, CVS, Editas, Evolve Pharmacy, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, HealthFirst, Health Partners, Humana, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Pfizer, Premera, Prime Therapeutics, Regeneron, Sanofi, Spark Therapeutics, uniQure, and United Healthcare. Beinfeld, McKenna, Rind, and Pearson are employed by ICER. Touchette received funding from ICER for work on this report and has also received fees from Monument Analytics and AstraZeneca, unrelated to this work. The University of Illinois at Chicago (UIC) and Touchette hold a patent for the model described in this report. The model is included in ICER's Interactive Modeler, for which a fee is paid to UIC and Touchette. Atlas also received funding from ICER for work on this report.

Cancer screening and timely follow-up of abnormal results can reduce mortality. One barrier to follow-up is the failure to identify abnormal results. While EHRs have coded results for certain tests, cancer screening results are often stored in free-text reports, which limit capabilities for automated decision support. As part of the multilevel Follow-up of Cancer Screening (mFOCUS) trial, we developed and implemented a natural language processing (NLP) tool to assist with real-time detection of abnormal cancer screening test results (including mammograms, low-dose chest CT scans, and Pap smears) and identification of gynecological follow-up for higher risk abnormalities (i.e. colposcopy) from free-text reports. We demonstrate the integration and implementation of NLP, within the mFOCUS system, to improve the follow-up of abnormal cancer screening results in a large integrated healthcare system. The NLP pipelines have detected scenarios when guideline-recommended care was not delivered, in part because the provider mis-identified the text-based result reports.

Cancer screening and timely follow-up of abnormal results can reduce mortality. One barrier to follow-up is the failure to identify abnormal results. While EHRs have coded results for certain tests, cancer screening results are often stored in free-text reports, which limit capabilities for automated decision support. As part of the multilevel Follow-up of Cancer Screening (mFOCUS) trial, we developed and implemented a natural language processing (NLP) tool to assist with real-time detection of abnormal cancer screening test results (including mammograms, low-dose chest CT scans, and Pap smears) and identification of gynecological follow-up for higher risk abnormalities (i.e. colposcopy) from free-text reports. We demonstrate the integration and implementation of NLP, within the mFOCUS system, to improve the follow-up of abnormal cancer screening results in a large integrated healthcare system. The NLP pipelines have detected scenarios when guideline-recommended care was not delivered, in part because the provider mis-identified the text-based result reports.

We characterized monitor utilization in stroke survivors and assessed associations with underlying clinical atrial fibrillation (AF) risk. We retrospectively analyzed consecutive patients with acute ischemic stroke 10/2018-6/2019 without prevalent AF and assessed the 6-month incidence of monitor utilization (Holter/ECG, event/patch, implantable loop recorder [ILR]) using Fine-Gray models accounting for the competing risk of death. We assessed for predictors of monitor utilization using cause-specific hazards regression adjusted for the Cohorts for Heart and Aging Research in Genomic Epidemiology AF (CHARGE-AF) score, stroke subtype, and discharge disposition. Of 493 patients with acute ischemic stroke (age 65±16; 47% women), the 6-month incidence of monitor utilization was 36.5% (95% CI 31.7, 41.3), and 6-month mortality was 13.6% (10.4, 16.8). Monitoring was performed with Holter/event (n = 107; 72.3%), ILR (n = 34; 23.0%) or both (n = 7; 4.7%). Monitoring was more likely after cryptogenic (hazard ratio [HR] 4.53 [3.22, 6.39]; 6-month monitor incidence 70.6%) and cardioembolic (HR 2.43 [1.28, 4.62]; incidence 47.7%) stroke, versus other/undocumented (incidence 22.7%). Among patients with cryptogenic stroke, the 6-month incidence of ILR was 27.5% [18.5, 36.5]. Monitoring was more likely after discharge home (HR 1.80 [1.29, 2.52]; incidence 46.1%) versus facility (incidence 24.9%). Monitoring was not associated with CHARGE-AF score (HR 1.08 per 1-SD increase [0.91, 1.27]), even though CHARGE-AF was associated with incident AF (HR 1.56 [1.03, 2.35]). In conclusion, rhythm monitors are utilized after one-third of ischemic strokes. Monitoring is more frequent after cryptogenic strokes, though ILR use is low. Monitor utilization is not associated with AF risk.

Objective Disagreement exists between rheumatology and primary care societies regarding gout management. This paper describes a formal process for gathering input from stakeholders in the planning of a trial to compare gout management strategies. Methods We recruited patients, nurses, physician assistants, primary care clinicians, and rheumatologists to participate in a modified Delphi panel (mDP) to provide input on design of a trial focused on optimal management for primary care patients with gout. The 16 panelists received a plain-language briefing document that discussed the rationale for the trial, key clinical issues in gout, and aspects of trial design. The panelists also received information and considerations on nine voting questions (VQs), judged to be the key design questions. Cognitive interviews with panelists ensured that the VQs were understood by the range of panelists involved in the mDP. Panelists were asked to score all VQs from 1 (definitely no) to 9 (definitely yes). Two voting rounds were conducted-round 1 by email and round 2 by video conference. Results The VQs were modified through the cognitive interviews. The round 1 voting resulted in consensus on eight items, with consensus defined as median voting score in the same tercile (1-3, 4-6 or 7-9). Re-voting at the meeting (round 2) reached consensus on the remaining item. Conclusion An mDP with various stakeholders facilitated consensus on the design of a trial of different management strategies for chronic gout. This method may be useful for designing trials of clinical questions with substantial disagreement across stakeholders.

Patient navigation (PN) improves initial colorectal cancer (CRC) screening in underserved populations. Whether the impact persists and improves the timeliness of follow-up screening colonoscopy (FSC) is not known. Patients receiving PN at initial colonoscopy between 2010-2011 with findings requiring FSC were matched to unnavigated patients requiring FSC. The primary outcome was proportion of patients with timely FSC, defined as colonoscopy within six months of recommendation. Of 216 patients in the study 103 (48%) completed FSC: 33 of 62 (53%) who received PN compared with 70 of 154 (45%) in the control group (p=.30). After adjusting for insurance, education, language and visits, navigated patients had higher odds (AOR=1.53, 95% CI 0.80-2.92) of timely FSC completion compared with unnavigated patients. Timely FSC completion in underserved patients is low. Patients navigated for initial colonoscopy or not had similar rates of FSC completion. Future studies should investigate navigation for FSC to improve equity in CRC.

Thousands of colonoscopies were canceled during the initial surge of the COVID-19 pandemic. As facilities resumed services, some patients were hesitant to reschedule. The purpose of this study was to determine whether a decision aid plus telephone coaching would increase colorectal cancer (CRC) screening and improve patient reports of shared decision making (SDM). A randomized controlled trial assigned adults aged 45-75 without prior history of CRC who had a colonoscopy canceled from March to May 2020 to intervention (n = 400) or usual care control (n = 400) arms. The intervention arm received three-page decision aid and call from decision coach from September 2020 through November 2020. Screening rates were collected at 6 months. A subset (n = 250) in each arm was surveyed 8 weeks after randomization to assess SDM (scores range 0-4, higher scores indicating more SDM), decisional conflict, and screening preference. The sample was on average, 60 years old, 53% female, 74% White, non-Hispanic, and 11% Spanish speaking. More intervention arm patients were screened within 6 months (35% intervention vs 23% control, p 0.001). The intervention respondents reported higher SDM scores (mean difference 0.7 [0.4, 0.9], p 0.001) and less decisional conflict than controls (-21% [-35%, -7%], p = 0.003). The majority in both arms preferred screening versus delaying (68% intervention vs. 65% control, p = 0.75). An SDM approach that offered alternatives and incorporated patients' preferences resulted in higher screening rates. Patients who are overdue for CRC screening may benefit from proactive outreach with SDM support.

Undiagnosed atrial fibrillation (AF) is an important cause of stroke. Screening for AF using wrist-worn wearable devices may prevent strokes, but their cost-effectiveness is unknown.To evaluate the cost-effectiveness of contemporary AF screening strategies, particularly wrist-worn wearable devices.This economic evaluation used a microsimulation decision-analytic model and was conducted from September 8, 2020, to May 23, 2022, comprising 30 million simulated individuals with an age, sex, and comorbidity profile matching the US population aged 65 years or older.Eight AF screening strategies, with 6 using wrist-worn wearable devices (watch or band photoplethysmography, with or without watch or band electrocardiography) and 2 using traditional modalities (ie, pulse palpation and 12-lead electrocardiogram) vs no screening.The primary outcome was the incremental cost-effectiveness ratio, defined as US dollars per quality-adjusted life-year (QALY). Secondary measures included rates of stroke and major bleeding.In the base case analysis of this model, the mean (SD) age was 72.5 (7.5) years, and 50% of the individuals were women. All 6 screening strategies using wrist-worn wearable devices were estimated to be more effective than no screening (range of QALYs gained vs no screening, 226-957 per 100 000 individuals) and were associated with greater relative benefit than screening using traditional modalities (range of QALYs gained vs no screening, -116 to 93 per 100 000 individuals). Compared with no screening, screening using wrist-worn wearable devices was associated with a reduction in stroke incidence by 20 to 23 per 100 000 person-years but an increase in major bleeding by 20 to 44 per 100 000 person-years. The overall preferred strategy was wearable photoplethysmography, followed conditionally by wearable electrocardiography with patch monitor confirmation, which had an incremental cost-effectiveness ratio of $57 894 per QALY, meeting the acceptability threshold of $100 000 per QALY. The cost-effectiveness of screening was consistent across multiple scenarios, including strata of sex, screening at earlier ages (eg, ≥50 years), and with variation in the association of anticoagulation with risk of stroke in the setting of screening-detected AF.This economic evaluation of AF screening using a microsimulation decision-analytic model suggests that screening using wearable devices is cost-effective compared with either no screening or AF screening using traditional methods.

Background For adults aged 76–85, guidelines recommend individualizing decision-making about whether to continue colorectal cancer (CRC) testing. These conversations can be challenging as they need to consider a patient’s CRC risk, life expectancy, and preferences. Objective To promote shared decision-making (SDM) for CRC testing decisions for older adults. Design Two-arm, multi-site cluster randomized trial, assigning physicians to Intervention and Comparator arms. Patients were surveyed shortly after the visit to assess outcomes. Analyses were intention-to-treat. Participants and Setting Primary care physicians affiliated with 5 academic and community hospital networks and their patients aged 76–85 who were due for CRC testing and had a visit during the study period. Interventions Intervention arm physicians completed a 2-h online course in SDM communication skills and received an electronic reminder of patients eligible for CRC testing shortly before the visit. Comparator arm received reminders only. Main Measures The primary outcome was patient-reported SDM Process score (range 0–4 with higher scores indicating more SDM); secondary outcomes included patient-reported discussion of CRC screening, knowledge, intention, and satisfaction with the visit. Key Results Sixty-seven physicians (Intervention n=34 and Comparator n=33) enrolled. Patient participants (n=466) were on average 79 years old, 50% with excellent or very good self-rated overall health, and 66% had one or more prior colonoscopies. Patients in the Intervention arm had higher SDM Process scores (adjusted mean difference 0.36 (95%CI (0.08, 0.64), p=0.01) than in the Comparator arm. More patients in the Intervention arm reported discussing CRC screening during the visit (72% vs. 60%, p=0.03) and had higher intention to follow through with their preferred approach (58.0% vs. 47.1, p=0.03). Knowledge scores and visit satisfaction did not differ significantly between arms. Conclusion Physician training plus reminders were effective in increasing SDM and frequency of CRC testing discussions in an age group where SDM is essential. Trial Registration The trial is registered on clinicaltrials.gov (NCT03959696).

Colorectal cancer (CRC) is the second leading cause of cancer death in the US. Screening has decreased CRC mortality. However, disadvantaged patients, particularly those with mental illness or substance use disorder (SUD), are less likely to be screened. The aim of this trial was to evaluate the impact of a patient navigation program on CRC screening in patients with mental illness and/or SUD.A pilot randomized nonblinded controlled trial was conducted from January to June 2017 in an urban community health center serving a low-income population. We randomized 251 patients aged 50-74 years with mental illness and/or SUD diagnosis overdue for CRC screening to intervention (Navigators contacted 85 patients (67%) in the intervention group and 26 declined to participate. In intention-to treat analysis, more patients in the intervention group received CRC screening than in the usual care group, 19% versus 10.4% (A patient navigation program improved CRC screening rates in patients with mental illness and/or SUD. Larger studies in diverse care settings are needed to demonstrate generalizability and explore which modality of CRC screening is most acceptable and which navigator activities are most effective for this vulnerable population.2016P001322.

BACKGROUND: Clarifying the relationship between pain phenotypes and physical function in older adults may enhance screening and treatment for functional decline in primary care settings. OBJECTIVE: To investigate the association of more severe pain phenotypes with neuromuscular impairments or mobility limitations among older community-dwelling primary care patients. DESIGN: Cross-sectional analysis. SETTING: The Boston Rehabilitative Impairment Study of the Elderly. PARTICIPANTS: Adults aged 65 years or older. METHODS: We counted the number of musculoskeletal pain locations (none, single site, multisite, or widespread) using the McGill Pain Questionnaire and identified pain intensity tertiles using the Brief Pain Inventory. Neuromuscular attributes (trunk extensor muscle endurance, and leg speed, strength, strength asymmetry, and range of motion) and mobility (Short Physical Performance Battery [SPPB]) were assessed with performance-based measures. Additionally, self-reported mobility was measured on the Late Life Function and Disability Instrument (LLFDI). For neuromuscular attributes and LLFDI, scores in the lowest tertile indicated neuromuscular impairment or mobility limitations, respectively. For SPPB, a score

DISCLOSURES: Funding for this summary was contributed by the Laura and John Arnold Foundation, National Institute for Health Care Management, California Health Care Foundation, Blue Cross Blue Shie...

This cohort study is a secondary analysis of the VITAL-AF trial and assesses the prevalence and incidence of atrial fibrillation among the trial’s control participants.

Since 2012, cervical cancer screening guidelines allow for choice of screening test for women age 30–65 years (i.e., Pap every 3 years or Pap with human papillomavirus co-testing every 5 years). Intended to give patients and providers options, this flexibility reflects a trend in the growing complexity of screening guidelines. Our objective was to characterize variation in cervical screening at the individual, provider, clinic/facility, and healthcare system levels. The analysis included 296,924 individuals receiving screening from 3626 providers at 136 clinics/facilities in three healthcare systems, 2010 to 2017. Main outcome was receipt of co-testing vs. Pap alone. Co-testing was more common in one healthcare system before the 2012 guidelines (adjusted odds ratio (AOR) of co-testing at the other systems relative to this system 0.00 and 0.50) but was increasingly implemented over time in a second with declining uptake in the third (2017: AORs shifted to 7.32 and 0.01). Despite system-level differences, there was greater heterogeneity in receipt of co-testing associated with providers than clinics/facilities. In the three healthcare systems, providers in the highest quartile of co-testing use had an 8.35, 8.81, and 25.05-times greater odds of providing a co-test to women with the same characteristics relative to the lowest quartile. Similarly, clinics/ facilities in the highest quartile of co-testing use had a 4.20, 3.14, and 6.56-times greater odds of providing a co-test relative to the lowest quartile. Variation in screening test use is associated with health system, provider, and clinic/facility levels even after accounting for patient characteristics.

Background Clinical guidelines recommend engaging patients in shared decision making for common orthopedic procedures; however, limited work has assessed what is occurring in practice. This study assessed the quality of shared decision making for elective hip and knee replacement and spine surgery at four network-affiliated hospitals. Methods A cross-sectional sample of 875 adult patients undergoing total hip or knee joint replacement (TJR) for osteoarthritis or spine surgery for lumbar herniated disc or lumbar spinal stenosis was selected. Patients were mailed a survey including measures of Shared Decision Making (SDMP scale) and Informed, Patient-Centered (IPC) decisions. We examined decision-making across sites, surgeons, and conditions, and whether the decision-making measures were associated with better health outcomes. Analyses were adjusted for clustering of patients within surgeons. Results Six hundred forty-six surveys (74% response rate) were returned with sufficient responses for analysis. Patients who had TJR reported lower SDMP scores than patients who had spine surgery (2.2 vs. 2.8; p p p > 0.09). Higher SDMP scores and IPC decisions were associated with larger improvements in global health outcomes for patients who had TJR, but not patients who had spine surgery. Conclusions Measures of shared decision making and decision quality varied among patients undergoing common elective orthopedic procedures. Routine measurement of shared decision making provides insight into areas of strength across these different orthopedic conditions as well as areas in need of improvement.

Screening for atrial fibrillation (AF) is attractive because AF independently raises the risk of ischemic stroke, this risk is largely reversible by long-term oral anticoagulant therapy (OAC), and many patients with AF remain undiagnosed and untreated. Recent trials of one-time brief screening for AF have not produced a significant increase in the proportion of patients diagnosed with AF. Trials of longer-term screening have demonstrated an increase in AF diagnoses, primarily paroxysmal AF. To date, however, no trials have demonstrated that screening for AF results in lower rates of stroke. Clinical practice guidelines conflict in their level of support for screening for AF.The GUARD-AF individually randomized trial is designed to test whether screening for AF in individuals age 70 years or greater using a 2-week single-lead electrocardiographic patch monitor can identify patients with undiagnosed AF and lead to treatment with OAC, resulting in a reduced rate of stroke in the screened population. The trial's efficacy end point is hospitalization for stroke (either ischemic or hemorrhagic) and the trial's safety end point is hospitalization for a bleeding event. End points will be ascertained via Medicare claims or electronic health records at 2.5 years after study start. Enrollment is based in primary care practices and the OAC decision for screen-detected cases is left to the patient and their physician. The initial planned target sample size was 52,000, with 26,000 allocated to either screening or to usual care.Trial enrollment was severely hampered by the novel coronavirus disease 2019 (COVID-19) pandemic and stopped at a total enrollment of 11,931 participants. Of 5,965 randomized to the screening arm, 5,713 patients (96%) returned monitors with analyzable results. Incidence of screen-detected and clinically detected AF and associated stroke and bleeding outcomes will be ascertained.GUARD-AF is the largest AF screening randomized trial using a longer-term patch-based continuous electrocardiographic monitor. The results will contribute important information on the yield of patch-based AF screening, the "burden" of AF detected (percent time in AF, longest episode), and physicians' OAC decisions as a function of AF burden. GUARD-AF's stroke and bleed results will contribute to pooled trial analyses of AF screening, thereby informing future studies and guidelines.

Background Performance of existing atrial fibrillation (AF) risk prediction models in poststroke populations is unclear. We evaluated predictive utility of an AF risk model in patients with acute stroke and assessed performance of a fully refitted model. Methods and Results Within an academic hospital, we included patients aged 46 to 94 years discharged for acute ischemic stroke between 2003 and 2018. We estimated 5‐year predicted probabilities of AF using the Cohorts for Heart and Aging Research in Genomic Epidemiology for Atrial Fibrillation (CHARGE‐AF) model, by recalibrating CHARGE‐AF to the baseline risk of the sample, and by fully refitting a Cox proportional hazards model to the stroke sample (Re‐CHARGE‐AF) model. We compared discrimination and calibration between models and used 200 bootstrap samples for optimism‐adjusted measures. Among 551 patients with acute stroke, there were 70 incident AF events over 5 years (cumulative incidence, 15.2%; 95% CI, 10.6%–19.5%). Median predicted 5‐year risk from CHARGE‐AF was 4.8% (quartile 1–quartile 3, 2.0–12.6) and from Re‐CHARGE‐AF was 16.1% (quartile 1–quartile 3, 8.0–26.2). For CHARGE‐AF, discrimination was moderate (C statistic, 0.64; 95% CI, 0.57–0.70) and calibration was poor, underestimating AF risk (Greenwood‐Nam D’Agostino chi‐square, P P P =0.001) compared with CHARGE‐AF (C statistic, 0.74 [95% CI, 0.68–0.79]; optimism‐adjusted, 0.70 [95% CI, 0.65–0.75]) and was well calibrated (Greenwood‐Nam D’Agostino chi‐square, P =0.97). Conclusions Covariates from an established AF risk model enable accurate estimation of AF risk in a poststroke population after recalibration. A fully refitted model was required to account for varying baseline AF hazard and strength of associations between covariates and incident AF.

Background Atrial fibrillation (AF) screening is endorsed by certain guidelines for individuals aged ≥65 years. Yet many AF screening strategies exist, including the use of wrist‐worn wearable devices, and their comparative effectiveness is not well‐understood. Methods and Results We developed a decision‐analytic model simulating 50 million individuals with an age, sex, and comorbidity profile matching the United States population aged ≥65 years (ie, with a guideline‐based AF screening indication). We modeled no screening, in addition to 45 distinct AF screening strategies (comprising different modalities and screening intervals), each initiated at a clinical encounter. The primary effectiveness measure was quality‐adjusted life‐years, with incident stroke and major bleeding as secondary measures. We defined continuous or nearly continuous modalities as those capable of monitoring beyond a single time‐point (eg, patch monitor), and discrete modalities as those capable of only instantaneous AF detection (eg, 12‐lead ECG). In total, 10 AF screening strategies were effective compared with no screening (300–1500 quality‐adjusted life‐years gained/100 000 individuals screened). Nine (90%) effective strategies involved use of a continuous or nearly continuous modality such as patch monitor or wrist‐worn wearable device, whereas 1 (10%) relied on discrete modalities alone. Effective strategies reduced stroke incidence (number needed to screen to prevent a stroke: 3087–4445) but increased major bleeding (number needed to screen to cause a major bleed: 1815–4049) and intracranial hemorrhage (number needed to screen to cause intracranial hemorrhage: 7693–16 950). The test specificity was a highly influential model parameter on screening effectiveness. Conclusions When modeled from a clinician‐directed perspective, the comparative effectiveness of population‐based AF screening varies substantially upon the specific strategy used. Future screening interventions and guidelines should consider the relative effectiveness of specific AF screening strategies.

Background: Undiagnosed atrial fibrillation (AF) may cause preventable strokes. Guidelines differ regarding AF screening recommendations. We tested whether point-of-care screening with a handheld single-lead ECG at primary care practice visits increases diagnoses of AF. Methods: We randomized 16 primary care clinics 1:1 to AF screening using a handheld single-lead ECG (AliveCor KardiaMobile) during vital sign assessments, or usual care. Patients included were ages ≥65 years. Screening results were provided to primary care clinicians at the encounter. All confirmatory diagnostic testing and treatment decisions were made by the primary care clinician. New AF diagnoses during the 1-year follow-up were ascertained electronically and manually adjudicated. Proportions and incidence rates were calculated. Effect heterogeneity was assessed. Results: Of 30 715 patients without prevalent AF (n=15 393 screening [91% screened], n=15 322 control), 1.72% of individuals in the screening group had new AF diagnosed at 1 year versus 1.59% in the control group (risk difference, 0.13% [95% CI, –0.16 to 0.42]; P =0.38). In prespecified subgroup analyses, new AF diagnoses in the screening and control groups were greater among those aged ≥85 years (5.56% versus 3.76%, respectively; risk difference, 1.80% [95% CI, 0.18 to 3.30]). The difference in newly diagnosed AF between the screening period and the previous year was marginally greater in the screening versus control group (0.32% versus –0.12%; risk difference, 0.43% [95% CI, –0.01 to 0.84]). The proportion of individuals with newly diagnosed AF who were initiated on oral anticoagulants was not different in the screening (n=194, 73.5%) and control (n=172, 70.8%) arms (risk difference, 2.7% [95% CI, –5.5 to 10.4]). Conclusions: Screening for AF using a single-lead ECG at primary care visits did not affect new AF diagnoses among all individuals aged 65 years or older compared with usual care. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03515057.

Linking individuals to community resources in order to help meet health-related social needs, such as food, medications, or transportation, may improve clinical outcomes. However, little is known about the mechanisms whereby such linkage interventions might improve health. The authors conducted a mixed-methods analysis consisting of outcomes from a prospective cohort study of a linkage intervention and a qualitative analysis of case records from participants. The cohort study included intervention participants who first enrolled between December 2014 and March 2015. Participants were excluded if they could not complete the assessment because of illness or language. The authors examined changes in cost-related medication underuse (CRMU), transportation barriers, and food insecurity (FI). For the qualitative analysis, a random sample of 80 participants was selected for electronic health record review – 40 cases who showed clinical improvement (responders) and 40 cases who did not (nonresponders). Themes were extracted by 3 reviewers guided by the immersion/crystallization approach. For the cohort study, 141 individuals were included; 138 (97.9%) completed follow-up. Comparing baseline to follow-up, there were significant reductions in the prevalence of CRMU (from 44.2% to 39.1%, P = .003) and transportation barriers (from 46.3% to 30.2%, P = .001), but not FI (from 40.4% to 38.2%, P = .73). For the qualitative study, emergent themes that helped differentiate responders and nonresponders included acuity of need, resource availability/access, and adequacy of the resource utilized. CRMU and transportation barriers may be important mechanisms by which linkage interventions improve health-related social needs. Patient-centered themes can help guide intervention improvements.