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1.
Heart Rhythm ; 2024 Apr 29.
Article En | MEDLINE | ID: mdl-38692342

BACKGROUND: Single-lead electrocardiograms (1L ECG) are increasingly used for atrial fibrillation (AF) detection. Automated 1L ECG interpretation may possess prognostic value for future AF among cases where screening does not result in a short-term AF diagnosis. OBJECTIVE: Investigate the association between automated 1L ECG interpretation and incident AF. METHODS: VITAL-AF was a randomized controlled trial investigating the effectiveness of screening for AF using 1L ECGs. For the present study, participants were divided into four groups based on automated classification of 1L ECGs. Patients with prevalent AF were excluded. Associations between groups and incident AF were assessed using Cox proportional hazards models adjusted for risk factors. The start of follow-up was defined as 60 days after the latest 1L ECG (as some individuals had numerous screening 1L ECGs). RESULTS: The study sample included: Never screened (n=16,306), Normal (n=10,914), Other (n=2,675), Possible AF (n=561). Possible AF had the highest AF incidence (5.91 per 100 person-years, 95% Confidence Interval [CI] 4.24-8.23). Possible AF was associated with greater hazard of incident AF compared to Normal (adjusted Hazard Ratio (2.48, 95% CI 1.66-3.71). Other was associated with greater hazard of incident AF when compared to Normal (1.41, 95% CI 1.04-1.90). CONCLUSIONS: In patients undergoing AF screening with 1L ECGs without prevalent AF or AF within 60 days of screening, presumptive positive and indeterminate 1L ECG interpretations were associated with future AF. Abnormal 1L ECGs may identify individuals at higher risk for future AF.

2.
Article En | MEDLINE | ID: mdl-38652505

BACKGROUND: Follow-up of abnormal results is essential to cervical cancer screening, but data on adherence to follow-up are limited. We describe patterns of follow-up after screening abnormalities and identify predictors of guideline-concordant follow-up. METHODS: We identified the index screening abnormality (positive human papillomavirus [HPV] test or atypical squamous cells of undetermined significance [ASC-US] or more severe cytology) among women 25-65 years old at three U.S. healthcare systems during 2010-2019. We estimated the cumulative incidence of surveillance testing, colposcopy, or treatment after the index abnormality and initial colposcopy. Logistic regressions were fit to identify predictors of guideline-concordant follow-up according to contemporaneous guidelines. RESULTS: Among 43,007 patients with an index abnormality, the cumulative incidence of any follow-up was 49.6% by 4 years for those with ASC-US/HPV-negative and higher for abnormalities warranting immediate colposcopy. The 1-year cumulative incidence of any follow-up after colposcopy was 70% for patients with normal results or cervical intraepithelial neoplasia (CIN) I and 90% for patients with CIN II+. Rates of concordant follow-up after screening and colposcopy were 52% and 47%. Discordant follow-up was associated with factors including age, race/ethnicity, overweight/obese BMI, and specific types of public payor coverage or being uninsured. CONCLUSIONS: Adherence to recommended follow-up of cytologic and histopathologic abnormalities is inconsistent in clinical practice. Concordance was poor for mild abnormalities and improved, though suboptimal, for more severe abnormalities. IMPACT: There remain gaps in the cervical cancer screening process in clinical practice. Further work is needed to understand barriers to appropriate management of cervical abnormalities.

4.
LGBT Health ; 2024 Apr 22.
Article En | MEDLINE | ID: mdl-38648535

Purpose: We examined characteristics of clinicians caring for transgender men and nonbinary (TMNB) individuals and guideline concordance of clinicians' cervical cancer screening recommendations. Methods: Using a survey of clinicians who performed ≥10 cervical cancer screenings in 2019, we studied characteristics of clinicians who do versus do not report caring for TMNB individuals and guideline concordance of screening recommendations for TMNB individuals with a cervix versus cisgender women. Results: In our sample (N = 492), 49.2% reported caring for TMNB individuals, and 25.4% reported performing cervical cancer screening for TMNB individuals with a cervix. Differences in guideline concordance of screening recommendations for TMNB individuals with a cervix versus cisgender women (45.8% vs. 50% concordant) were not statistically significant. Conclusion: Sizable proportions of clinicians cared for and performed cervical cancer screening for TMNB individuals. Research is needed to better understand clinicians' identified knowledge deficits to develop interventions (e.g., clinician trainings) to improve gender-affirming cervical cancer prevention.

5.
Patient Educ Couns ; 123: 108232, 2024 Jun.
Article En | MEDLINE | ID: mdl-38458091

OBJECTIVE: Understand how physicians' uncertainty tolerance (UT) in clinical care relates to their personal characteristics, perceptions and practices regarding shared decision making (SDM). METHODS: As part of a trial of SDM training about colorectal cancer screening, primary care physicians (n = 67) completed measures of their uncertainty tolerance in medical practice (Anxiety subscale of the Physician's Reactions to Uncertainty Scale, PRUS-A), and their SDM self-efficacy (confidence in SDM skills). Patients (N = 466) completed measures of SDM (SDM Process scale) after a clinical visit. Bivariate regression analyses and multilevel regression analyses examined relationships. RESULTS: Higher UT was associated with greater physician age (p = .01) and years in practice (p = 0.015), but not sex or race. Higher UT was associated with greater SDM self-efficacy (p < 0.001), but not patient-reported SDM. CONCLUSION: Greater age and practice experience predict greater physician UT, suggesting that UT might be improved through training, while UT is associated with greater confidence in SDM, suggesting that improving UT might improve SDM. However, UT was unassociated with patient-reported SDM, raising the need for further studies of these relationships. PRACTICE IMPLICATIONS: Developing and implementing training interventions aimed at increasing physician UT may be a promising way to promote SDM in clinical care.


Decision Making, Shared , Physicians, Primary Care , Humans , Infant , Uncertainty , Decision Making , Patient Participation , Physician-Patient Relations
6.
Int J Stroke ; : 17474930241246156, 2024 Apr 18.
Article En | MEDLINE | ID: mdl-38546170

BACKGROUND: Secondary prevention interventions to reduce post-stroke cognitive impairment (PSCI) can be aided by the early identification of high-risk individuals who would benefit from risk factor modification. AIMS: To develop and evaluate a predictive model to identify patients at increased risk of PSCI over 5 years using data easily accessible from electronic health records. METHODS: Cohort study that included primary care patients from two academic medical centers. Patients were aged 45 years or older, without prior stroke or prevalent cognitive impairment, with primary care visits and an incident ischemic stroke between 2003 and 2016 (development/internal validation cohort) or 2010 and 2022 (external validation cohort). Predictors of PSCI were ascertained from the electronic health record. The outcome was incident dementia/cognitive impairment within 5 years and beginning 3 months following stroke, ascertained using International Classification of Diseases, Ninth/Tenth Revision (ICD-9/10) codes. For model variable selection, we considered potential predictors of PSCI and constructed 400 bootstrap samples with two-thirds of the model derivation sample. We ran 10-fold cross-validated Cox proportional hazards models using a least absolute shrinkage and selection operator (LASSO) penalty. Variables selected in >25% of samples were included. RESULTS: The analysis included 332 incident diagnoses of PSCI in the development cohort (n = 3741), and 161 and 128 incident diagnoses in the internal (n = 1925) and external (n = 2237) validation cohorts, respectively. The C-statistic for predicting PSCI was 0.731 (95% confidence interval (CI): 0.694-0.768) in the internal validation cohort, and 0.724 (95% CI: 0.681-0.766) in the external validation cohort. A risk score based on the beta coefficients of predictors from the development cohort stratified patients into low (0-7 points), intermediate (8-11 points), and high (12-23 points) risk groups. The hazard ratios (HRs) for incident PSCI were significantly different by risk categories in internal (high, HR: 6.2, 95% CI: 4.1-9.3; Intermediate, HR: 2.7, 95% CI: 1.8-4.1) and external (high, HR: 6.1, 95% CI: 3.9-9.6; Intermediate, HR: 2.8, 95% CI: 1.9-4.3) validation cohorts. CONCLUSION: Five-year risk of PSCI can be accurately predicted using routinely collected data. Model output can be used to risk stratify and identify individuals at increased risk for PSCI for preventive efforts. DATA ACCESS STATEMENT: Mass General Brigham data contain protected health information and cannot be shared publicly. The data processing scripts used to perform analyses will be made available to interested researchers upon reasonable request to the corresponding author.

7.
medRxiv ; 2024 Feb 04.
Article En | MEDLINE | ID: mdl-38352557

Importance: Secondary prevention interventions to reduce post-stroke cognitive impairment (PSCI) can be aided by the early identification of high-risk individuals who would benefit from risk factor modification. Objective: To develop and evaluate a predictive model to identify patients at increased risk of PSCI over 5 years using data easily accessible from electronic health records. Design: Cohort study with patients enrolled between 2003-2016 with follow-up through 2022. Setting: Primary care practices affiliated with two academic medical centers. Participants: Individuals 45 years or older, without prior stroke or prevalent cognitive impairment, with primary care visits and an incident ischemic stroke between 2003-2016 (development/internal validation cohort) or 2010-2022 (external validation cohort). Exposures: Predictors of PSCI were ascertained from the electronic health record. Main Outcome: The outcome was incident dementia/cognitive impairment within 5 years and beginning 3 months following stroke, ascertained using ICD-9/10 codes. For model variable selection, we considered potential predictors of PSCI and constructed 400 bootstrap samples with two-thirds of the model derivation sample. We ran 10-fold cross-validated Cox proportional hazards models using a least absolute shrinkage and selection operator (LASSO) penalty. Variables selected in >25% of samples were included. Results: The analysis included 332 incident diagnoses of PSCI in the development cohort (n=3,741), and 161 and 128 incident diagnoses in the internal (n=1,925) and external (n=2,237) validation cohorts. The c-statistic for predicting PSCI was 0.731 (95% CI: 0.694-0.768) in the internal validation cohort, and 0.724 (95% CI: 0.681-0.766) in the external validation cohort. A risk score based on the beta coefficients of predictors from the development cohort stratified patients into low (0-7 points), intermediate (8-11 points), and high (12-35 points) risk groups. The hazard ratios for incident PSCI were significantly different by risk categories in internal (High, HR: 6.2, 95% CI 4.1-9.3; Intermediate, HR 2.7, 95% CI: 1.8-4.1) and external (High, HR: 6.1, 95% CI: 3.9-9.6; Intermediate, HR 2.8, 95% CI: 1.9-4.3) validation cohorts. Conclusions and Relevance: Five-year risk of PSCI can be accurately predicted using routinely collected data. Model output can be used to risk stratify and identify individuals at increased risk for PSCI for preventive efforts.

8.
Patient Educ Couns ; 119: 108047, 2024 Feb.
Article En | MEDLINE | ID: mdl-37976668

OBJECTIVE: Identify if primary care physicians (PCPs) accurately understand patient preferences for colorectal cancer (CRC) testing, whether shared decision making (SDM) training improves understanding of patient preferences, and whether time spent discussing CRC testing improves understanding of patient preferences. METHODS: Secondary analysis of a trial comparing SDM training plus a reminder arm to a reminder alone arm. PCPs and their patients completed surveys after visits assessing whether they discussed CRC testing, patient testing preference, and time spent discussing CRC testing. We compared patient and PCP responses, calculating concordance between patient-physician dyads. Multilevel models tested for differences in preference concordance by arm or time discussing CRC. RESULTS: 382 PCP and patient survey dyads were identified. Most dyads agreed on whether CRC testing was discussed (82%). Only 52% of dyads agreed on the patient's preference. SDM training did not impact accuracy of PCPs preference diagnoses (55%v.48%,p = 0.22). PCPs were more likely to accurately diagnose patient's preferences when discussions occurred, regardless of length. CONCLUSION: Only half of PCPs accurately identified patient testing preferences. Training did not impact accuracy. Visits where CRC testing was discussed resulted in PCPs better understanding patient preferences. PRACTICE IMPLICATIONS: PCPs should take time to discuss testing and elicit patient preferences.


Colonic Neoplasms , Colorectal Neoplasms , Physicians , Humans , Colonic Neoplasms/diagnosis , Colorectal Neoplasms/diagnosis , Early Detection of Cancer/methods , Patient Preference
9.
J Gen Intern Med ; 39(4): 578-586, 2024 Mar.
Article En | MEDLINE | ID: mdl-37856007

BACKGROUND: While nonpharmacologic treatments are increasingly endorsed as first-line therapy for low back pain (LBP) in clinical practice guidelines, it is unclear if use of these treatments is increasing or equitable. OBJECTIVE: Examine national trends in chiropractic care and physical rehabilitation (occupational/physical therapy (OT/PT)) use among adults with LBP. DESIGN/SETTING: Serial cross-sectional analysis of the National Health Interview Survey, 2002 to 2018. PARTICIPANTS: 146,087 adults reporting LBP in prior 3 months. METHODS: We evaluated the association of survey year with chiropractic care or OT/PT use in prior 12 months. Logistic regression with multilevel linear splines was used to determine if chiropractic care or OT/PT use increased after the introduction of clinical guidelines. We also examined trends in use by age, sex, race, and ethnicity. When trends were similar over time, we present differences by these demographic characteristics as unadjusted ORs using data from all respondents. RESULTS: Between 2002 and 2018, less than one-third of adults with LBP reported use of either chiropractic care or OT/PT. Rates did not change until 2016 when uptake increased with the introduction of clinical guidelines (2016-2018 vs 2002-2015, OR = 1.15; 95% CI: 1.10-1.19). Trends did not differ significantly by sex, race, or ethnicity (p for interactions > 0.05). Racial and ethnic disparities in chiropractic care or OT/PT use were identified and persisted over time. For example, compared to non-Hispanic adults, either chiropractic care or OT/PT use was lower among Hispanic adults (combined OR = 0.62, 95% CI: 0.65-0.73). By contrast, compared to White adults, Black adults had similar OT/PT use (OR = 0.98; 95% CI: 0.94-1.03) but lower for chiropractic care use (OR = 0.50; 95% CI: 0.47-0.53). CONCLUSIONS: Although use of chiropractic care or OT/PT for LBP increased after the introduction of clinical guidelines in 2016, only about a third of US adults with LBP reported using these services between 2016 and 2018 and disparities in use have not improved.


Chiropractic , Low Back Pain , Adult , Humans , Cross-Sectional Studies , Ethnicity , Low Back Pain/therapy , United States , Racial Groups
10.
J Am Heart Assoc ; 13(1): e032126, 2024 Jan 02.
Article En | MEDLINE | ID: mdl-38156452

BACKGROUND: Consumer wearable devices with health and wellness features are increasingly common and may enhance disease detection and management. Yet studies informing relationships between wearable device use, attitudes toward device data, and comprehensive clinical profiles are lacking. METHODS AND RESULTS: WATCH-IT (Wearable Activity Tracking for Comprehensive Healthcare-Integrated Technology) studied adults receiving longitudinal primary or ambulatory cardiovascular care in the Mass General Brigham health care system from January 2010 to July 2021. Participants completed a 20-question electronic survey about perceptions and use of consumer wearable devices, with responses linked to electronic health records. Multivariable logistic regression was used to identify factors associated with device use. Among 214 992 individuals receiving longitudinal primary or cardiovascular care with an active electronic portal, 11 121 responded (5.2%). Most respondents (55.8%) currently used a wearable device, and most nonusers (95.3%) would use a wearable if provided at no cost. Although most users (70.2%) had not shared device data with their doctor previously, most believed it would be very (20.4%) or moderately (34.4%) important to share device-related health information with providers. In multivariable models, older age (odds ratio [OR], 0.80 per 10-year increase [95% CI, 0.77-0.82]), male sex (OR, 0.87 [95% CI, 0.80-0.95]), and heart failure (OR, 0.75 [95% CI, 0.63-0.89]) were associated with lower odds of wearable device use, whereas higher median income (OR, 1.08 per 1-quartile increase [95% CI, 1.04-1.12]) and care in a cardiovascular medicine clinic (OR, 1.17 [95% CI, 1.05-1.30]) were associated with greater odds of device use. CONCLUSIONS: Among patients in primary and cardiovascular medicine clinics, consumer wearable device use is common, and most users perceive value in wearable health data.


Wearable Electronic Devices , Adult , Humans , Male , Surveys and Questionnaires , Electronic Health Records , Attitude , Delivery of Health Care
11.
JAMA ; 330(14): 1348-1358, 2023 10 10.
Article En | MEDLINE | ID: mdl-37815566

Importance: Realizing the benefits of cancer screening requires testing of eligible individuals and processes to ensure follow-up of abnormal results. Objective: To test interventions to improve timely follow-up of overdue abnormal breast, cervical, colorectal, and lung cancer screening results. Design, Setting, and Participants: Pragmatic, cluster randomized clinical trial conducted at 44 primary care practices within 3 health networks in the US enrolling patients with at least 1 abnormal cancer screening test result not yet followed up between August 24, 2020, and December 13, 2021. Intervention: Automated algorithms developed using data from electronic health records (EHRs) recommended follow-up actions and times for abnormal screening results. Primary care practices were randomized in a 1:1:1:1 ratio to (1) usual care, (2) EHR reminders, (3) EHR reminders and outreach (a patient letter was sent at week 2 and a phone call at week 4), or (4) EHR reminders, outreach, and navigation (a patient letter was sent at week 2 and a navigator outreach phone call at week 4). Patients, physicians, and practices were unblinded to treatment assignment. Main Outcomes and Measures: The primary outcome was completion of recommended follow-up within 120 days of study enrollment. The secondary outcomes included completion of recommended follow-up within 240 days of enrollment and completion of recommended follow-up within 120 days and 240 days for specific cancer types and levels of risk. Results: Among 11 980 patients (median age, 60 years [IQR, 52-69 years]; 64.8% were women; 83.3% were White; and 15.4% were insured through Medicaid) with an abnormal cancer screening test result for colorectal cancer (8245 patients [69%]), cervical cancer (2596 patients [22%]), breast cancer (1005 patients [8%]), or lung cancer (134 patients [1%]) and abnormal test results categorized as low risk (6082 patients [51%]), medium risk (3712 patients [31%]), or high risk (2186 patients [18%]), the adjusted proportion who completed recommended follow-up within 120 days was 31.4% in the EHR reminders, outreach, and navigation group (n = 3455), 31.0% in the EHR reminders and outreach group (n = 2569), 22.7% in the EHR reminders group (n = 3254), and 22.9% in the usual care group (n = 2702) (adjusted absolute difference for comparison of EHR reminders, outreach, and navigation group vs usual care, 8.5% [95% CI, 4.8%-12.0%], P < .001). The secondary outcomes showed similar results for completion of recommended follow-up within 240 days and by subgroups for cancer type and level of risk for the abnormal screening result. Conclusions and Relevance: A multilevel primary care intervention that included EHR reminders and patient outreach with or without patient navigation improved timely follow-up of overdue abnormal cancer screening test results for breast, cervical, colorectal, and lung cancer. Trial Registration: ClinicalTrials.gov Identifier: NCT03979495.


Delayed Diagnosis , Early Detection of Cancer , Health Communication , Neoplasms , Primary Health Care , Reminder Systems , Female , Humans , Male , Middle Aged , Colorectal Neoplasms/diagnosis , Early Detection of Cancer/methods , Early Detection of Cancer/statistics & numerical data , Lung Neoplasms/diagnosis , Mass Screening/methods , Primary Health Care/methods , Primary Health Care/statistics & numerical data , Aftercare , Time Factors , Delayed Diagnosis/prevention & control , Delayed Diagnosis/statistics & numerical data , Neoplasms/diagnosis , Neoplasms/epidemiology , Pragmatic Clinical Trials as Topic , United States/epidemiology , Aged , Reminder Systems/statistics & numerical data , Electronic Health Records , Patient Navigation , Health Communication/methods
12.
Res Sq ; 2023 Sep 26.
Article En | MEDLINE | ID: mdl-37841859

Background: Lifestyle modification programs, such as cardiac rehabilitation, may reduce atrial fibrillation (AF) burden and improve quality of life (QOL), but remain unproven. The objective of this pilot study was to assess feasibility, acceptability, and preliminary effectiveness of an exercise and nutrition-based cardiac rehabilitation-like program for AF patients. Methods: We enrolled overweight adults aged ≥ 30 years with symptomatic AF in a 12-week cardiac lifestyle group program, including 6 virtual and 6 in-person visits. All visits included discussion and education about nutrition, exercise, and behavior modification. In-person visits included supervised aerobic exercise and strength training. Outcomes at baseline and 12 weeks included feasibility of participation, acceptability, change in weight and BMI, and changes in survey-based AF burden, symptoms, and QOL. Results: From 84 invitees, 11 (13.1%) were enrolled (mean age 64; baseline BMI 38 kg/m2); 9 (82%) completed the program. Patients attended an average of 9.7 (81%) visits (Range: 6-11). Mean weight loss was 9.1 pounds (Range: 0-16); mean BMI decrease was 1.4 kg/m2 (Range: 0-2.6). Patients found the program helpful overall: all reported making diet and exercise changes during the program. Compared to baseline, patients reported decreased AF burden (12.9 vs. 11.7, p = 0.03) and symptom (10.1 vs. 5.6, p = 0.003) scores at the conclusion of the program. Patients also reported increased QOL overall (68.9 vs. 86.4, p = 0.001). Conclusions: Participation in a cardiac rehab-like program was feasible and acceptable for overweight patients with symptomatic AF. Results suggest preliminary effectiveness of the program for reducing AF burden and symptoms and increasing QOL.

13.
medRxiv ; 2023 Aug 12.
Article En | MEDLINE | ID: mdl-37609134

Introduction: Consumer wearable devices with health and wellness features are increasingly common and may enhance prevention and management of cardiovascular disease. However, the characteristics and attitudes of wearable device users versus non-users are poorly understood. Methods: Wearable Activity Tracking for Comprehensive Healthcare-Integrated Technology (WATCH-IT) was a prospective study of adults aged ≥18 years receiving longitudinal primary or ambulatory cardiovascular care at one of eleven hospitals within the Mass General Brigham multi-institutional healthcare system between January 2010-July 2021. We invited patients, including wearable users and non-users, to participate via an electronic patient portal. Participants were asked to complete a 20-question survey regarding perceptions and use of consumer wearable devices. Responses were linked to electronic health record data. Multivariable logistic regression was used to identify factors associated with device use. Results: Among 280,834 individuals receiving longitudinal primary or cardiovascular care, 65,842 did not have an active electronic portal or opted out of research contact. Of the 214,992 individuals sent a survey link, 11,121 responded (5.2%), comprising the WATCH-IT patient sample. Most respondents (55.8%) reported current use of a wearable device, and most non-users (95.3%) reported they would use a wearable device if provided at no cost. Although most users (70.2%) had not shared device data with their doctor previously, the majority believed it would be very (20.4%) or moderately (34.4%) important to share device-related health information with providers. In multivariable models, older age (odds ratio [OR] 0.80 per 10-year increase, 95% CI 0.77-0.82), male sex (0.87, 95% CI 0.80-0.95), and heart failure (0.75, 95% CI 0.63-0.89) were associated with lower odds of wearable device use, whereas higher median zip code income (1.08 per 1-quartile increase, 95% CI 1.04-1.12) and care in a cardiovascular medicine clinic (1.17, 95% CI 1.05-1.30) were associated with greater odds of device use. Nearly all respondents (98%) stated they would share device data with researchers studying health outcomes. Conclusions: Within an electronically assembled cohort of patients in primary and cardiovascular medicine clinics with linkage to detailed health records, wearable device use is common. Most users perceive value in wearable data. Our platform may enable future study of the relationships between wearable technology and resource utilization, clinical outcomes, and health disparities.

14.
Heart Rhythm O2 ; 4(8): 469-477, 2023 Aug.
Article En | MEDLINE | ID: mdl-37645259

Background: Despite benefits of oral anticoagulation (OAC), many individuals with diagnosed atrial fibrillation (AF) do not receive OAC. Objective: The purpose of this study was to assess whether cardiac rhythm assessment for AF impacted use of OAC in patients with previously diagnosed AF. Methods: VITAL-AF was a cluster randomized controlled trial conducted in 16 primary care practices assessing the efficacy of AF rhythm assessment with single-lead electrocardiogram in routine care. Patients 65 years and older were offered rhythm assessment at visits. In this secondary analysis, we evaluated rhythm assessment uptake and compared initiation and discontinuation of OAC in patients with previously diagnosed AF from intervention and control arms over 1 year. Results: The study included 4593 patients with previously diagnosed AF (2250 intervention; 2343 control). In the intervention arm, 2022 (89.9%) completed rhythm assessment (median 2 visits with rhythm assessment) and 40.1% had ≥1 "Possible AF" result. Initiation of OAC was similar in the intervention (17.7%) and control (19.1%) arms but was influenced by the rhythm assessment result: higher with a "Possible AF" (26.1%; adjusted odds ratio [aOR] 1.62; 95% confidence interval [CI] 1.04-2.51), and lower with a "Normal" result (9.9%; aOR 0.45; 95% CI 0.29-0.71) compared to control. OAC discontinuation was similar in the intervention (6.3%) and control (7.2%) arms, with lower discontinuation with a "Possible AF" result (3.8%; aOR 0.51; 95% CI 0.32-0.81). Conclusions: Including patients with previously diagnosed AF in a point-of-care rhythm assessment strategy did not increase overall OAC use compared to the control arm. However, the rhythm assessment result influenced both initiation and discontinuation of OAC.

15.
Am Heart J ; 265: 92-103, 2023 Nov.
Article En | MEDLINE | ID: mdl-37451355

BACKGROUND: Screening for atrial fibrillation (AF) using consumer-based devices capable of producing a single lead electrocardiogram (1L ECG) is increasing. There are limited data on the accuracy of physician interpretation of these tracings. The goal of this study is to assess the sensitivity, specificity, confidence, and variability of cardiologist interpretation of point-of-care 1L ECGs. METHODS: Fifteen cardiologists reviewed point-of-care handheld 1L ECGs collected from patients aged 65 years or older enrolled in the VITAL-AF clinical trial [NCT035115057] who underwent cardiac rhythm assessments with a 1L ECG using an AliveCor KardiaMobile device. Random sampling of 1L ECGs for cardiologist review was stratified by the AliveCor algorithm interpretation. A 12L ECG performed on the same day for clinical purposes was used as the gold standard. Cardiologists each reviewed a common sample of 200 1L ECG tracings and completed a survey associated with each tracing. Cardiologists were blinded to both the AliveCor algorithm and same day 12L ECG interpretation. For each tracing, study cardiologists were asked to assess the rhythm (sinus rhythm, AF, unclassifiable), report their assessment of the quality of the tracing, and rate their confidence in rhythm interpretation. The outcomes included the sensitivity, specificity, variability, and confidence in physician interpretation. Variables associated with each measure were identified using multivariable regression. RESULTS: The average sensitivity for AF was 77.4% (range 50%-90.6%, standard deviation [SD]=11.4%) and the average specificity was 73.0% (range 41.3%-94.6%, SD = 15.4%). The mean variability was 30.8% (range 0%-76.2%, SD = 23.2%). The average reviewer confidence of 1L ECG rhythm assessment was 3.6 out of 5 (range 2.5-4.2, SD = 0.6). Patient and tracing factors associated with sensitivity, specificity, variability, and confidence were identified and included age, body mass index, and presence of artifact. CONCLUSION: Cardiologist interpretation of point-of-care handheld 1L ECGs has modest diagnostic sensitivity and specificity with substantial variability for AF classification despite high confidence. Variability in cardiologist interpretation of 1L ECGs highlights the importance of confirmatory testing for diagnosing AF.

16.
BMC Prim Care ; 24(1): 135, 2023 06 30.
Article En | MEDLINE | ID: mdl-37391738

BACKGROUND: Screening for atrial fibrillation (AF) is appealing because AF is common, when undiagnosed may increase stroke risk, and stroke is preventable with anticoagulants. This study assessed patient and primary care practitioner (PCP) acceptability of screening for AF using a 30-s single-lead electrocardiogram (SL-ECG) during outpatient visits. METHODS: Secondary analyses of a cluster randomized trial. All patients ≥ 65 years old without prevalent AF seen during a 1-year period and their PCPs. Screening using a SL-ECG was performed by medical assistants during check-in at 8 intervention sites among verbally consenting patients. PCPs were notified of "possible AF" results; management was left to their discretion. Control practices continued with usual care. Following the trial, PCPs were surveyed about AF screening. Outcomes included screening uptake and results, and PCP preferences for screening. RESULTS: Fifteen thousand three hundred ninety three patients were seen in intervention practices (mean age 73.9 years old, 59.7% female). Screening occurred at 78% of 38,502 individual encounters, and 91% of patients completed ≥ 1 screening. The positive predictive value of a "Possible AF" result (4.7% of SL-ECG tracings) at an encounter prior to a new AF diagnosis was 9.5%. Same-day 12-lead ECGs were slightly more frequent among intervention (7.0%) than control (6.2%) encounters (p = 0.07). Among the 208 PCPs completing a survey (73.6%; 78.9% intervention, 67.7% control), most favored screening for AF (87.2% vs. 83.6%, respectively), though SL-ECG screening was favored by intervention PCPs (86%) while control PCPs favored pulse palpation (65%). Both groups were less certain if AF screening should be done outside of office visits with patch monitors (47% unsure) or consumer devices (54% unsure). CONCLUSIONS: Though the benefits and harms of screening for AF remain uncertain, most older patients underwent screening and PCPs were able to manage SL-ECG results, supporting the feasibility of routine primary care screening. PCPs exposed to a SL-ECG device preferred it over pulse palpation. PCPs were largely uncertain about AF screening done outside of practice visits. TRIAL REGISTRATION: ClinicalTrials.gov NCT03515057. Registered May 3, 2018.


Atrial Fibrillation , Humans , Female , Aged , Male , Atrial Fibrillation/diagnosis , Atrial Fibrillation/epidemiology , Biological Transport , Heart Rate , Electrocardiography , Primary Health Care
17.
Prev Med Rep ; 35: 102279, 2023 Oct.
Article En | MEDLINE | ID: mdl-37361923

Frequently changing cervical cancer screening guidelines over the past two decades have been inconsistently adopted in the United States. Current guidelines set the recommended screening interval to three years for average-risk women aged 21-29 years. Few studies have evaluated how patient and provider factors are associated with implementation of cervical cancer screening intervals among younger women. This study evaluated multilevel factors associated with screening interval length among 69,939 women aged 21-29 years with an initial negative Pap screen between 2010 and 2015 across three large health systems in the U.S. Shorter-interval screening was defined as a second screening Pap within 2.5 years of an initial negative Pap. Mixed-effects logistic regression was performed for each site to identify provider and patient characteristics associated with shorter-interval screening. The odds of shorter-interval screening decreased over the study period across all sites, though the proportion of patients screened within 2.5 years remained between 7.5% and 20.7% across sites in 2014-2015. Patient factors including insurance, race/ethnicity, and pregnancy were associated with shorter-interval screening, though the patterns differed across sites. At one site, the variation in shorter-interval screening explained by the provider was 10.6%, whereas at the other two sites, the provider accounted for < 2% of the variation in shorter-interval screening. Our results highlight the heterogeneity in factors driving cervical cancer screening interval across health systems and point to the need for tailored approaches targeted to both providers and patients to improve guideline-concordant screening.

19.
JAMA Netw Open ; 6(2): e2255838, 2023 02 01.
Article En | MEDLINE | ID: mdl-36780164

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.


Atrial Fibrillation , Humans , Atrial Fibrillation/epidemiology , Incidence , Prevalence , Risk Factors , Primary Health Care
20.
Value Health ; 26(6): 823-832, 2023 06.
Article En | MEDLINE | ID: mdl-36529422

OBJECTIVES: Nadofaragene firadenovec is a gene therapy for bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) undergoing Food and Drug Administration review. Pembrolizumab is approved for treating patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS). We evaluated the cost-effectiveness of these treatments compared with a hypothetical therapeutic alternative, at a willingness-to-pay threshold of $150 000 per quality-adjusted life-year (QALY) gained, in CIS and non-CIS BCG-unresponsive NMIBC populations. METHODS: We developed a Markov cohort simulation model with a 3-month cycle length and lifetime horizon to estimate the 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. RESULTS: Nadofaragene firadenovec, at a placeholder price 10% higher than the price of pembrolizumab, had an incremental cost-effectiveness ratio of $263 000 and $145 000 per QALY gained in CIS and non-CIS populations, respectively. Pembrolizumab had an incremental cost-effectiveness ratio 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 to the probabilities of disease progression, initial treatment response and durability, and drug price. CONCLUSIONS: The cost-effectiveness of nadofaragene firadenovec will depend upon its price. Pembrolizumab, although 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.


Antineoplastic Agents , Non-Muscle Invasive Bladder Neoplasms , Urinary Bladder Neoplasms , Humans , BCG Vaccine/therapeutic use , Cost-Benefit Analysis , Urinary Bladder Neoplasms/drug therapy , Antineoplastic Agents/therapeutic use , Immunotherapy , Quality-Adjusted Life Years
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