Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization.

BACKGROUND: In the BEST-CLI trial (Best Endovascular Versus Best Surgical Therapy for Patients With Chronic Limb-Threatening Ischemia), a prespecified secondary objective was to assess the effects of revascularization strategy on health-related quality of life (HRQoL). METHODS: Patients with chronic limb-threatening ischemia were randomized to surgical bypass (Bypass) or endovascular intervention (Endo) in 2 parallel trials. Cohort 1 included patients with single-segment great saphenous vein; cohort 2 included those lacking suitable single-segment great saphenous vein. HRQoL was assessed over the trial duration using Vascular Quality-of-Life (VascuQoL), European Quality-of-Life-5D (EQ-5D), the Short Form-12 (SF-12) Physical Component Summary (SF-12 PCS), SF-12 Mental Component Summary (SF-12 MCS), Utility Index Score (SF-6D R2), and numeric rating scales of pain. HRQoL was summarized by cohort and compared within and between groups using mixed-model linear regression. RESULTS: A total of 1193 and 335 patients in cohorts 1 and 2 with a mean follow-up of 2.9 and 2.0 years, respectively, were analyzed. In cohort 1, HRQoL significantly improved from baseline to follow-up for both groups across all measures. For example, mean (SD) VascuQoL scores were 3.0 (1.3) and 3.0 (1.2) for Bypass and Endo at baseline and 4.7 (1.4) and 4.8 (1.5) over follow-up. There were significant group differences favoring Endo when assessed with VascuQoL (difference, -0.14 [95% CI, -0.25 to -0.02]; P=0.02), SF-12 MCS (difference, -1.03 [95% CI, -1.89 to -0.18]; P=0.02), SF-6D R2 (difference, -0.01 [95% CI, -0.02 to -0.001]; P=0.03), numeric rating scale pain at present (difference, 0.26 [95% CI, 0.03 to 0.49]; P=0.03), usual level during previous week (difference, 0.26 [95% CI, 0.04 to 0.48]; P=0.02), and worst level during previous week (difference, 0.29 [95% CI, 0.02 to 0.56]; P=0.04). There was no difference between treatment arms on the basis of EQ-5D (difference, -0.01 [95% CI, -0.03 to 0.004]; P=0.12) or SF-12 PCS (difference, -0.41 [95% CI, -1.2 to 0.37]; P=0.31). In cohort 2, HRQoL also significantly improved from baseline to the end of follow-up for both groups based on all measures, but there were no differences between Bypass and Endo on any measure. CONCLUSIONS: Among patients with chronic limb-threatening ischemia deemed eligible for either Bypass or Endo, revascularization resulted in significant and clinically meaningful improvements in HRQoL. In patients with an available single-segment great saphenous vein for bypass, but not among those without one, Endo was statistically superior on some HRQoL measures; however, these differences were below the threshold of clinically meaningful difference.

Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia.

BACKGROUND: Patients with chronic limb-threatening ischemia (CLTI) require revascularization to improve limb perfusion and thereby limit the risk of amputation. It is uncertain whether an initial strategy of endovascular therapy or surgical revascularization for CLTI is superior for improving limb outcomes. METHODS: In this international, randomized trial, we enrolled 1830 patients with CLTI and infrainguinal peripheral artery disease in two parallel-cohort trials. Patients who had a single segment of great saphenous vein that could be used for surgery were assigned to cohort 1. Patients who needed an alternative bypass conduit were assigned to cohort 2. The primary outcome was a composite of a major adverse limb event - which was defined as amputation above the ankle or a major limb reintervention (a new bypass graft or graft revision, thrombectomy, or thrombolysis) - or death from any cause. RESULTS: In cohort 1, after a median follow-up of 2.7 years, a primary-outcome event occurred in 302 of 709 patients (42.6%) in the surgical group and in 408 of 711 patients (57.4%) in the endovascular group (hazard ratio, 0.68; 95% confidence interval [CI], 0.59 to 0.79; P<0.001). In cohort 2, a primary-outcome event occurred in 83 of 194 patients (42.8%) in the surgical group and in 95 of 199 patients (47.7%) in the endovascular group (hazard ratio, 0.79; 95% CI, 0.58 to 1.06; P = 0.12) after a median follow-up of 1.6 years. The incidence of adverse events was similar in the two groups in the two cohorts. CONCLUSIONS: Among patients with CLTI who had an adequate great saphenous vein for surgical revascularization (cohort 1), the incidence of a major adverse limb event or death was significantly lower in the surgical group than in the endovascular group. Among the patients who lacked an adequate saphenous vein conduit (cohort 2), the outcomes in the two groups were similar. (Funded by the National Heart, Lung, and Blood Institute; BEST-CLI ClinicalTrials.gov number, NCT02060630.).

Testing interventions to reduce clinical inertia in the treatment of hypertension: rationale and design of a pragmatic randomized controlled trial.

BACKGROUND: Clinical inertia, or failure to intensify treatment when indicated, leads to suboptimal blood pressure control. Interventions to overcome inertia and increase antihypertensive prescribing have been modestly successful in part because their effectiveness varies based on characteristics of the provider, the patient, or the provider-patient interaction. Understanding for whom each intervention is most effective could help target interventions and thus increase their impact. METHODS: This three-arm, randomized trial tests the effectiveness of 2 interventions to reduce clinical inertia in hypertension prescribing compared to usual care. Forty five primary care providers (PCPs) caring for patients with hypertension in need of treatment intensification completed baseline surveys that assessed behavioral traits and were randomized to one of three arms: 1) Pharmacist e-consult, in which a clinical pharmacist provided patient-specific recommendations for hypertension medication management to PCPs in advance of upcoming visits, 2) Social norming dashboards that displayed PCP's hypertension control rates compared to those of their peers, or 3) Usual care (no intervention). The primary outcome was the rate of intensification of hypertension treatment. We will compare this outcome between study arms and then evaluate the association between characteristics of providers, patients, their clinical interactions, and intervention responsiveness. RESULTS: Forty-five primary care providers were enrolled and randomized: 16 providers and 173 patients in the social norming dashboards arm, 15 providers and 143 patients in the pharmacist e-consult arm, and 14 providers and 150 patients in the usual care arm. On average, the mean patient age was 64 years, 47% were female, and 73% were white. Baseline demographic and clinical characteristics of patients were similar across arms, with the exception of more Hispanic patients in the usual care arm and fewest in the pharmacist e-consult arm. CONCLUSIONS: This study can help identify interventions to reduce inertia in hypertension care and potentially identify the characteristics of patients, providers, or patient-provider interactions to understand for whom each intervention would be most beneficial. TRIAL REGISTRATION: Clinicaltrials.gov (NCT, Registered: NCT04603560).

"How" Versus "Why" Messaging to Increase Uptake of Booster Vaccination Against COVID-19: Results of a Pragmatic Randomized Trial.

BACKGROUND: Messages aimed at increasing uptake of vaccines have been modestly successful, perhaps in part because they often focus on why individuals should receive a vaccine. Construal Level Theory posits that messages emphasizing "how" to get a vaccine may be more effective at encouraging vaccination than emphasizing "why." This message framing may be particularly important for COVID-19 booster acceptance. OBJECTIVE: To determine if pre-visit patient portal messages designed using Construal Level Theory increase rates of COVID-19 booster vaccination. DESIGN AND INTERVENTIONS: This 3-arm randomized trial was conducted across three large, diverse primary care clinics in Massachusetts between February and May 2022, testing the impact of "how" versus "why" framed pre-visit messages versus no messages ("usual care"). Messages were sent by patient portal two business days before a visit. PARTICIPANTS: Adults with upcoming primary care visits who had electronic health record evidence of receiving their initial COVID-19 vaccination series but not a booster dose. MAIN MEASURES: Receipt of a COVID-19 booster vaccination after the message was sent through the visit date (primary outcome) or 6 weeks (secondary outcome). KEY RESULTS: A total of 3665 patients were randomized (mean age: 53.5 years (SD: 17.3), 59% female, 65.2% White, 26.6% Hispanic), with 1249 to "how" 1199 to "why," and 1217 to usual care arms. Except for clinic and preferred language, characteristics were well balanced across arms. Rates of COVID-19 booster were 13.6% (usual care), 11.7% ("how") (odds ratio (OR) "how" vs usual care: 0.87, 95%CI: 0.67-1.14), and 13.7% ("why") ("why" vs usual care: OR: 1.01, 95%CI: 0.81-1.28). At 6 weeks, "why" outperformed "how" for vaccination (OR: 1.26, 95%CI: 1.06-1.49), with no difference versus usual care. CONCLUSIONS: We found no differences on visit booster receipt after single pre-visit portal messages designed using Construal Level Theory. Further studies to identify effective messaging interventions are needed, especially as additional doses are recommended. CLINICAL TRIAL REGISTRATION: This trial is registered at clinicaltrials.gov, ID: NCT04871776 . Initial release occurred 04/30/2021.

Disentangling drug contributions: anticholinergic burden in older adults linked to individual medications: a cross-sectional population-based study.

BACKGROUND: Medications with potent anticholinergic properties have well-documented adverse effects. A high cumulative anticholinergic burden may arise from the concurrent use of multiple medications with weaker anticholinergic effects. We sought to identify patterns of high anticholinergic burden and associated patient characteristics. METHODS: We identified patients aged ≥ 65 who filled ≥ 1 medication with anticholinergic adverse effects in 2019 and had a cumulative Anticholinergic Burden score (ACB) ≥ 4 (i.e., high anticholinergic burden) in a large US health insurer. We classified patients based on how they attained high burden, as follows: 1) only filling strong or moderate anticholinergic medications (i.e., ACB = 2 or 3, "moderate/strong"), 2) only filling lightly anticholinergic medications (i.e., ACB = 1, "light/possible"), and 3) filling any combination ("mix"). We used multinomial logistic regression to assess the association between measured patient characteristics and membership in the three anticholinergic burden classifications, using the moderate/strong group as the referent. RESULTS: In total, 83,286 eligible patients with high anticholinergic burden were identified (mean age: 74.3 years (SD:7.1), 72.9% female). Of these, 4.5% filled only strong/moderate anticholinergics, 4.3% filled only light/possible anticholinergics, and the rest filled a mix (91.2%). Within patients in the mixed group, 64.3% of medication fills were for light/possible anticholinergics, while 35.7% were for moderate/strong anticholinergics. Compared with patients in the moderate/strong anticholinergics group, patients filling only light/possible anticholinergics were more likely to be older (adjusted Odds Ratio [aOR] per 1-unit of age: 1.06, 95%CI: 1.05-1.07), less likely to be female (aOR: 0.56, 95%CI: 0.50-0.62 vs. male), more likely to have comorbidities (e.g., heart failure aOR: 3.18, 95%CI: 2.70-3.74 or depression aOR: 1.20, 95%CI: 1.09-1.33 vs. no comorbidity), and visited fewer physicians (aOR per 1-unit of change: 0.98, 95%CI: 0.97-0.98). Patients in the mixed group were older (aOR per 1-unit of age: 1.02, 95%CI: 1.02-1.03) and less likely to be female (aOR: 0.89, 95%CI: 0.82-0.97 vs. male) compared with those filling moderate/strong anticholinergics. CONCLUSION: Most older adults accumulated high anticholinergic burden through a combination of light/possible and moderate/strong anticholinergics rather than moderate/strong anticholinergics, with light/possible anticholinergics being the major drivers of overall anticholinergic burden. These insights may inform interventions to improve prescribing in older adults.

Artificial Intelligence and Technology Collaboratories: Innovating aging research and Alzheimer's care.

This perspective outlines the Artificial Intelligence and Technology Collaboratories (AITC) at Johns Hopkins University, University of Pennsylvania, and University of Massachusetts, highlighting their roles in developing AI-based technologies for older adult care, particularly targeting Alzheimer's disease (AD). These National Institute on Aging (NIA) centers foster collaboration among clinicians, gerontologists, ethicists, business professionals, and engineers to create AI solutions. Key activities include identifying technology needs, stakeholder engagement, training, mentoring, data integration, and navigating ethical challenges. The objective is to apply these innovations effectively in real-world scenarios, including in rural settings. In addition, the AITC focuses on developing best practices for AI application in the care of older adults, facilitating pilot studies, and addressing ethical concerns related to technology development for older adults with cognitive impairment, with the ultimate aim of improving the lives of older adults and their caregivers. HIGHLIGHTS: Addressing the complex needs of older adults with Alzheimer's disease (AD) requires a comprehensive approach, integrating medical and social support. Current gaps in training, techniques, tools, and expertise hinder uniform access across communities and health care settings. Artificial intelligence (AI) and digital technologies hold promise in transforming care for this demographic. Yet, transitioning these innovations from concept to marketable products presents significant challenges, often stalling promising advancements in the developmental phase. The Artificial Intelligence and Technology Collaboratories (AITC) program, funded by the National Institute on Aging (NIA), presents a viable model. These Collaboratories foster the development and implementation of AI methods and technologies through projects aimed at improving care for older Americans, particularly those with AD, and promote the sharing of best practices in AI and technology integration. Why Does This Matter? The National Institute on Aging (NIA) Artificial Intelligence and Technology Collaboratories (AITC) program's mission is to accelerate the adoption of artificial intelligence (AI) and new technologies for the betterment of older adults, especially those with dementia. By bridging scientific and technological expertise, fostering clinical and industry partnerships, and enhancing the sharing of best practices, this program can significantly improve the health and quality of life for older adults with Alzheimer's disease (AD).

Disagreement between pharmacy claims and direct interview to identify patients with non-adherence to chronic cardiometabolic medications.

BACKGROUND: Accurate methods of identifying patients with suboptimal adherence to cardiometabolic medications are needed, and each approach has benefits and tradeoffs. METHODS: We used data from a large trial of patients with poorly controlled cardiometabolic disease and evidence of medication non-adherence measured using pharmacy claims data whose adherence was subsequently assessed during a telephone consultation with a clinical pharmacist. We then evaluated if the pharmacist assessment agreed with the non-adherence measured using claims. When pharmacist and claims assessments disagreed, we identified reasons why claims were insufficient and used multivariable modified Poisson regression to identify patient characteristics associated with disagreement. RESULTS: Of 1,069 patients identified as non-adherent using claims (proportion of days covered [PDC] <80%), 646 (60.4%) were confirmed as non-adherent on pharmacist interview. For the 423 patients (39.6%) where the interview disagreed with the claims, the most common reasons were paying cash or using an alternate insurance (36.6%), medication discontinuation or regimen change (32.8%), and recently becoming adherent (26.7%). Compared to patients whose claims and interview both showed non-adherence, patients whose interview disagreed with claims were less likely to miss outpatient office visits (RR:0.91, 95%CI:0.85-0.97) and more likely to have a baseline PDC above the median (RR:1.35, 95%CI:1.10-1.64). CONCLUSIONS: Among patients identified as non-adherent by claims, 39.6% were observed to be adherent when assessed during pharmacist consultation. This discrepancy was largely driven by paying out-of-pocket, using alternative insurance, or medication discontinuation or change. These findings have important implications for using pharmacy claims to identify and intervene upon medication non-adherence.

Reducing ethnic and racial disparities by improving undertreatment, control, and engagement in blood pressure management with health information technology (REDUCE-BP) hybrid effectiveness-implementation pragmatic trial: Rationale and design.

BACKGROUND: While racial/ethnic disparities in blood pressure control are documented, few interventions have successfully reduced these gaps. Under-prescribing, lack of treatment intensification, and suboptimal follow-up care are thought to be central contributors. Electronic health record (EHR) tools may help address these barriers and may be enhanced with behavioral science techniques. OBJECTIVE: To evaluate the impact of a multicomponent behaviorally-informed EHR-based intervention on blood pressure control. TRIAL DESIGN: Reducing Ethnic and racial Disparities by improving Undertreatment, Control, and Engagement in Blood Pressure management with health information technology (REDUCE-BP) (NCT05030467) is a two-arm cluster-randomized hybrid type 1 pragmatic trial in a large multi-ethnic health care system. Twenty-four clinics (>350 primary care providers [PCPs] and >10,000 eligible patients) are assigned to either multi-component EHR-based intervention or usual care. Intervention clinic PCPs will receive several EHR tools designed to reduce disparities delivered at different points, including a: (1) dashboard of all patients visible upon logging on to the EHR displaying blood pressure control by race/ethnicity compared to their PCP peers and (2) set of tools in an individual patient's chart containing decision support to encourage treatment intensification, ordering home blood pressure measurement, interventions to address health-related social needs, default text for note documentation, and enhanced patient education materials. The primary outcome is patient-level change in systolic blood pressure over 12 months between arms; secondary outcomes include changes in disparities and other clinical outcomes. CONCLUSION: REDUCE-BP will provide important insights into whether an EHR-based intervention designed using behavioral science can improve hypertension control and reduce disparities.

A pragmatic clinical trial assessing the effect of a targeted notification and clinical support pathway on the diagnostic evaluation and treatment of individuals with left ventricular hypertrophy (NOTIFY-LVH).

BACKGROUND: Electronic health records contain vast amounts of cardiovascular data, including potential clues suggesting unrecognized conditions. One important example is the identification of left ventricular hypertrophy (LVH) on echocardiography. If the underlying causes are untreated, individuals are at increased risk of developing clinically significant pathology. As the most common cause of LVH, hypertension accounts for more cardiovascular deaths than any other modifiable risk factor. Contemporary healthcare systems have suboptimal mechanisms for detecting and effectively implementing hypertension treatment before downstream consequences develop. Thus, there is an urgent need to validate alternative intervention strategies for individuals with preexisting-but potentially unrecognized-LVH. METHODS: Through a randomized pragmatic trial within a large integrated healthcare system, we will study the impact of a centralized clinical support pathway on the diagnosis and treatment of hypertension and other LVH-associated diseases in individuals with echocardiographic evidence of concentric LVH. Approximately 600 individuals who are not treated for hypertension and who do not have a known cardiomyopathy will be randomized. The intervention will be directed by population health coordinators who will notify longitudinal clinicians and offer to assist with the diagnostic evaluation of LVH. Our hypothesis is that an intervention that alerts clinicians to the presence of LVH will increase the detection and treatment of hypertension and the diagnosis of alternative causes of thickened myocardium. The primary outcome is the initiation of an antihypertensive medication. Secondary outcomes include new hypertension diagnoses and new cardiomyopathy diagnoses. The trial began in March 2023 and outcomes will be assessed 12 months from the start of follow-up. CONCLUSION: The NOTIFY-LVH trial will assess the efficacy of a centralized intervention to improve the detection and treatment of hypertension and LVH-associated diseases. Additionally, it will serve as a proof-of-concept for how to effectively utilize previously collected electronic health data to improve the recognition and management of a broad range of chronic cardiovascular conditions. TRIAL REGISTRATION: NCT05713916.

Baseline modern medical management in the BEST-CLI trial.

OBJECTIVES: The use of optimal medical therapy (OMT) in patients with chronic limb-threatening ischemia (CLTI) has not been well-studied. The Best Endovascular vs Best Surgical Therapy in Patients with CLTI study (BEST-CLI) is a multicenter, randomized, controlled trial sponsored by the National Institutes of Health comparing revascularization strategies in patients with CLTI. We evaluated the use of guideline-based OMT among patients with CLTI at the time of their enrollment into the trial. METHODS: A multidisciplinary committee defined OMT criteria related to blood pressure and diabetic management, lipid-lowering and antiplatelet medication use, and smoking status for patients enrolled in BEST-CLI. Status reports indicating adherence to OMT were provided to participating sites at regular intervals. Baseline demographic characteristics, comorbid medical conditions, and use of OMT at trial entry were evaluated for all randomized patients. A linear regression model was used to identify the relationship of predictors to the use of OMT. RESULTS: At the time of randomization (n = 1830 total enrolled), 87% of patients in BEST-CLI had hypertension, 69% had diabetes, 73% had hyperlipidemia, and 35% were currently smoking. Adherence to four OMT components (controlled blood pressure, not currently smoking, use of one lipid-lowering medication, and use of an antiplatelet agent) was modest. Only 25% of patients met all four OMT criteria; 38% met three, 24% met two, 11% met only one, and 2% met none. Age ≥80 years, coronary artery disease, diabetes, and Hispanic ethnicity were positively associated, whereas Black race was negatively associated, with the use of OMT. CONCLUSIONS: A significant proportion of patients in BEST-CLI did not meet OMT guideline-based recommendations at time of entry. These data suggest a persistent major gap in the medical management of patients with advanced peripheral atherosclerosis and CLTI. Changes in OMT adherence over the course of the trial and their impact on clinical outcomes and quality of life will be assessed in future analyses.

Factors associated with lower preoperative quality of life in patients with chronic limb-threatening ischemia in the BEST-CLI trial.

OBJECTIVES: There are few contemporary data regarding health-related quality of life (HRQOL) measures in patients with chronic limb-threatening ischemia (CLI). METHODS: The Best Endovascular versus Best Surgical Therapy in Patients with CLI (BEST-CLI) trial is an ongoing, National Institutes of Health-sponsored, multicenter, randomized, controlled trial comparing revascularization strategies in patients with CLI. BEST-CLI baseline HRQOL measures were evaluated for patient-specific variables that were associated with poor HRQOL and then compared with published outcomes. The HRQOL measures Vascular Quality of Life Questionnaire (VascQOL), European Quality of Life 5D (EQ-5D), and the Short Form 12 (SF-12) Index score, physical component score (PCS) and mental component score (MCS) were aggregated from preoperative questionnaires completed by trial patients at baseline visits. Multivariable linear regression models were fit to determine which baseline characteristics were associated with poor HRQOL. RESULTS: We randomized 1830 patients into BEST-CLI. The majority (94.9%, 95.8%, and 95.8%) completed the VascQOL, EQ-5D, and SF-12 instruments at baseline, respectively. In the VascQOL, female sex, smoking history, opioid use, and nonindependent ambulation predicted lower HRQOL scores. Overall, VascuQOL scores were similar to those of participants in the Bypass versus Angioplasty in Severe Ischemia of the Leg (mean, 3.07 ± 1.2 vs mean, 2.9 ± 1.1; P = .07). In EQ-5D, nonindependent ambulation predicted lower HRQOL scores. In the SF-12, female sex, opioid use, nonindependent ambulation, and a history of smoking predicted lower HRQOL scores. The mean SF-12 PCS for all patients in the study was 33.0 ± 8.5 and for the MCS was 46.4 ± 12.0), significantly lower than the national SF-12 scores for US population ages more than 60 years, which is a PCS of 46.5 ± 11.4 and an MCS of 52.9 ± 8.7. CONCLUSIONS: Patients with CLI entering the BEST-CLI trial have very low HRQOL scores, comparable with patients suffering from other chronic conditions characterized by physical limitations and chronic pain. A history of smoking, impaired ambulation, opioid use, and female sex predicted lower HRQOL in patients with CLI, using multiple HRQOL measurement tools.

Leveraging Social Networks for the Assessment and Management of Neurological Patients.

Social networks are the persons surrounding a patient who provide support, circulate information, and influence health behaviors. For patients seen by neurologists, social networks are one of the most proximate social determinants of health that are actually accessible to clinicians, compared with wider social forces such as structural inequalities. We can measure social networks and related phenomena of social connection using a growing set of scalable and quantitative tools increasing familiarity with social network effects and mechanisms. This scientific approach is built on decades of neurobiological and psychological research highlighting the impact of the social environment on physical and mental well-being, nervous system structure, and neuro-recovery. Here, we review the biology and psychology of social networks, assessment methods including novel social sensors, and the design of network interventions and social therapeutics.

Prescribing decision making by medical residents on night shifts: A qualitative study.

INTRODUCTION: Prescribing of medications with well-known adverse effects, like antipsychotics or benzodiazepines, during hospitalisation is extremely common despite guideline recommendations against their use. Barriers to optimal prescribing, including perceived pressure from allied health professionals and fatigue, may be particularly pronounced for less experienced medical residents, especially during night shifts when these medications are often prescribed. Under these circumstances, physicians may be more likely to use 'quick', often referred to as System 1 choices, rather than 'considered' System 2 strategies for decisions. Understanding how medical residents use, these different cognitive approaches could help develop interventions to improve prescribing. METHODS: To understand decision-making and contextual contributors that influence suboptimal prescribing during night coverage by medical residents, we conducted semi-structured qualitative interviews with residents in general medicine inpatient settings. The interviews elicited perspectives on shift routines, stressful situations, factors influencing prescribing decision making and hypothetical measures that could improve prescribing. Interviews were audio-recorded and transcribed. Data were analysed using codes developed by the team to generate themes using immersion/crystallisation approaches. RESULTS: We conducted interviews with 21 medical residents; 47% were female, 43% were White, and 43% were Asian. We identified five key themes: (i) time pressures affecting prescribing decisions, (ii) fears of judgement by senior physicians and peers and being responsible for patient outcomes, (iii) perceived pressure from nursing staff, amplified by nurses' greater experience, (iv) clinical acuity as a key factor influencing prescribing, and (v) strategies to improve communication between members of the care team, like ensuring adequate hand-off by day teams. CONCLUSION: Medical residents highlighted numerous contextual factors that promote quick thinking rather than slower thinking when prescribing on night shifts, particularly time constraints, perceived pressure and patient clinical acuity. Interventions aimed at reducing prescribing should address how to manage stress and perceived pressure in decision making.

Factors associated with early nonpersistence among patients experiencing side effects from a new medication.

BACKGROUND: Drug discontinuation (i.e., nonpersistence) is often attributed to the emergence of adverse effects. However, it is not known whether other factors increase the risk of nonpersistence when adverse effects occur. OBJECTIVES: To identify factors associated with early nonpersistence among patients experiencing adverse effects from newly prescribed medications. METHODS: A questionnaire was mailed to new users of antihypertensive, antihyperglycemic, and lipid-lowering medications in Saskatchewan, Canada, between 2019 and 2020. Only respondents experiencing adverse effects were included. Responses were compared between the nonpersistent group (i.e., people who had discontinued their medication) and the persistent group (i.e., those who were taking their medication at the time of the survey). Statistically significant factors were tested in multivariable logistic regression models. Odds ratios (ORs) and 95% CIs were reported. RESULTS: Of the 3973 returned questionnaires, 813 respondents experienced adverse -effects from their new medication and were included in the study. Of these, 143 respondents (17.5%) had stopped their medication at the time of survey completion; most discontinuations (72.1%) occurred within 1 month of the first dose. Nonpersistent patients were older, had lower income, and were less likely to be taking an antihyperglycemic medication. After covariate adjustment, 6 factors were independently associated with nonpersistence: age less than 65 years (OR 1.56 [95% CI 1.01-2.41]), female sex (1.67 [1.08-2.59]), health condition not considered dangerous (2.09 [1.25-3.51]), medication not considered important for health (6.90 [4.40-10.84]), failure to expect adverse effects before starting medication (2.67 [1.74-4.10]), and taking 2 or more medications (0.45 [0.27-0.73]). CONCLUSION: Despite the strong link between the emergence of adverse effects and early nonpersistence, our findings confirm that this association is highly influenced by several factors external to the physical experiences caused by the new medication.

Effect of a Biopsychosocial Intervention or Postural Therapy on Disability and Health Care Spending Among Patients With Acute and Subacute Spine Pain: The SPINE CARE Randomized Clinical Trial.

Importance: Low back and neck pain are often self-limited, but health care spending remains high. Objective: To evaluate the effects of 2 interventions that emphasize noninvasive care for spine pain. Design, Setting, and Participants: Pragmatic, cluster, randomized clinical trial conducted at 33 centers in the US that enrolled 2971 participants with neck or back pain of 3 months' duration or less (enrollment, June 2017 to March 2020; final follow-up, March 2021). Interventions: Participants were randomized at the clinic-level to (1) usual care (n = 992); (2) a risk-stratified, multidisciplinary intervention (the identify, coordinate, and enhance [ICE] care model that combines physical therapy, health coach counseling, and consultation from a specialist in pain medicine or rehabilitation) (n = 829); or (3) individualized postural therapy (IPT), a postural therapy approach that combines physical therapy with building self-efficacy and self-management (n = 1150). Main Outcomes and Measures: The primary outcomes were change in Oswestry Disability Index (ODI) score at 3 months (range, 0 [best] to 100 [worst]; minimal clinically important difference, 6) and spine-related health care spending at 1 year. A 2-sided significance threshold of .025 was used to define statistical significance. Results: Among 2971 participants randomized (mean age, 51.7 years; 1792 women [60.3%]), 2733 (92%) finished the trial. Between baseline and 3-month follow-up, mean ODI scores changed from 31.2 to 15.4 for ICE, from 29.3 to 15.4 for IPT, and from 28.9 to 19.5 for usual care. At 3-month follow-up, absolute differences compared with usual care were -5.8 (95% CI, -7.7 to -3.9; P < .001) for ICE and -4.3 (95% CI, -5.9 to -2.6; P < .001) for IPT. Mean 12-month spending was $1448, $2528, and $1587 in the ICE, IPT, and usual care groups, respectively. Differences in spending compared with usual care were -$139 (risk ratio, 0.93 [95% CI, 0.87 to 0.997]; P = .04) for ICE and $941 (risk ratio, 1.40 [95% CI, 1.35 to 1.45]; P < .001) for IPT. Conclusions and Relevance: Among patients with acute or subacute spine pain, a multidisciplinary biopsychosocial intervention or an individualized postural therapy intervention, each compared with usual care, resulted in small but statistically significant reductions in pain-related disability at 3 months. However, compared with usual care, the biopsychosocial intervention resulted in no significant difference in spine-related health care spending and the postural therapy intervention resulted in significantly greater spine-related health care spending at 1 year. Trial Registration: ClinicalTrials.gov Identifier: NCT03083886.

Recommendations for the Conduct and Reporting of Research Involving Flexible Electronic Health Record-Based Interventions.

In the past 2 decades, the United States has seen widespread adoption of electronic health records (EHRs) and a transition from mostly locally developed EHRs to commercial systems. However, most research on quality improvement and safety interventions in EHRs is still conducted at a single site, in a single EHR. Although single-site studies are important early in the innovation lifecycle, multisite studies of EHR interventions are critical for generalizability. Because EHR software, configuration, and local context differ considerably across health care organizations, it can be difficult to implement a single, standardized intervention across multiple sites in a study. This article outlines key strengths, weaknesses, challenges, and opportunities for standardization of EHR interventions in multisite studies and describes flexible trial designs suitable for studying complex interventions, including EHR interventions. It also outlines key considerations for reporting on flexible trials of EHR interventions, including sharing details of the process for designing interventions and their content, details of outcomes being studied and approaches for pooling, and the importance of sharing code and configuration whenever possible.

Preferences for mHealth Technology and Text Messaging Communication in Patients With Type 2 Diabetes: Qualitative Interview Study.

BACKGROUND: Individuals with diabetes need regular support to help them manage their diabetes on their own, ideally delivered via mechanisms that they already use, such as their mobile phones. One reason for the modest effectiveness of prior technology-based interventions may be that the patient perspective has been insufficiently incorporated. OBJECTIVE: This study aims to understand patients' preferences for mobile health (mHealth) technology and how that technology can be integrated into patients' routines, especially with regard to medication use. METHODS: We conducted semistructured qualitative individual interviews with patients with type 2 diabetes from an urban health care system to elicit and explore their perspectives on diabetes medication-taking behaviors, daily patterns of using mobile technology, use of mHealth technology for diabetes care, acceptability of text messages to support medication adherence, and preferred framing of information within text messages to support diabetes care. The interviews were digitally recorded and transcribed. The data were analyzed using codes developed by the study team to generate themes, with representative quotations selected as illustrations. RESULTS: We conducted interviews with 20 participants, of whom 12 (60%) were female and 9 (45%) were White; in addition, the participants' mean glycated hemoglobin A1c control was 7.8 (SD 1.1). Overall, 5 key themes were identified: patients try to incorporate cues into their routines to help them with consistent medication taking; many patients leverage some form of technology as a cue to support adherence to medication taking and diabetes self-management behaviors; patients value simplicity and integration of technology solutions used for diabetes care, managing medications, and communicating with health care providers; some patients express reluctance to rely on mobile technology for these diabetes care behaviors; and patients believe they prefer positively framed communication, but communication preferences are highly individualized. CONCLUSIONS: The participants expressed some hesitation about using mobile technology in supporting diabetes self-management but have largely incorporated it or are open to incorporating it as a cue to make medication taking more automatic and less burdensome. When using technology to support diabetes self-management, participants exhibited individualized preferences, but overall, they preferred simple and positively framed communication. mHealth interventions may be improved by focusing on integrating them easily into daily routines and increasing the customization of content.

A bronchial-airway gene-expression classifier to improve the diagnosis of lung cancer: Clinical outcomes and cost-effectiveness analysis.

Bronchoscopy is the safest procedure for lung cancer diagnosis when an invasive evaluation is required after imaging procedures. However, its sensitivity is relatively low, especially for small and peripheral lesions. We assessed benefits and costs of introducing a bronchial gene-expression classifier (BGC) to improve the performance of bronchoscopy and the overall diagnostic process for early detection of lung cancer. We used discrete-event simulation to compare clinical and economic outcomes of two different strategies with the standard practice in former and current smokers with indeterminate nodules: (i) location-based strategy-integrated the BGC to the bronchoscopy indication; (ii) simplified strategy-extended use of bronchoscopy plus BGC also on small and peripheral lesions. Outcomes modeled were rate of invasive procedures, quality-adjusted-life-years (QALYs), costs and incremental cost-effectiveness ratios. Compared to the standard practice, the location-based strategy (i) reduced absolute rate of invasive procedures by 3.3% without increasing costs at the current BGC market price. It resulted in savings when the BGC price was less than $3,000. The simplified strategy (ii) reduced absolute rate of invasive procedures by 10% and improved quality-adjusted life expectancy, producing an incremental cost-effectiveness ratio of $10,109 per QALY. In patients with indeterminate nodules, both BGC strategies reduced unnecessary invasive procedures at high risk of adverse events. Moreover, compared to the standard practice, the simplified use of BGC for central and peripheral lesions resulted in larger QALYs gains at acceptable cost. The location-based is cost-saving if the price of classifier declines.

The accuracy of self-reported blood pressure in the Medication adherence Improvement Support App For Engagement-Blood Pressure (MedISAFE-BP) trial: Implications for pragmatic trials.

Self-report of health conditions and behaviors is one potential strategy to increase the pace of enrollment into pragmatic clinical trials. In this study, we assessed the accuracy of self-reported poorly controlled hypertension among adults in the community who were screened for participation in the MedISAFE-BP trial. Of individuals who self-reported poorly controlled hypertension using the online trial enrollment platform, 64% had a systolic blood pressure less than 140 mm Hg when measured at home. Although we identified several characteristics associated with accurate self-report including older age (odds ratio [OR] 1.02 per year, 95% CI 1.01-1.03), diabetes (OR 1.59, 95% CI 1.17-2.14), and low health activation (OR 1.56 95% CI 1.17-2.07), we were unable to identify patients for whom self-reported hypertension would be a reliable method for their inclusion in a pragmatic trial.

Comparison of a new 3-item self-reported measure of adherence to medication with pharmacy claims data in patients with cardiometabolic disease.

BACKGROUND: Less than half of patients with cardiometabolic disease consistently take prescribed medications. While health insurers and some delivery organizations use claims to measure adherence, most clinicians do not have access during routine interactions. Self-reported scales exist, but their practical utility is often limited by length or cost. By contrast, the accuracy of a new 3-item self-reported measure has been demonstrated in individuals with HIV. We evaluated its concordance with claims-based adherence measures in cardiometabolic disease. METHODS: We used data from a recently-completed pragmatic trial of patients with cardiometabolic conditions. After 12 months of follow-up, intervention subjects were mailed a survey with the 3-item measure that queries about medication use in the prior 30 days. Responses were linearly transformed and averaged. Adherence was also measured in claims in month 12 and months 1-12 of the trial using proportion of days covered (PDC) metrics. We compared validation metrics for non-adherence for self-report (average <0.80) compared with claims (PDC <0.80). RESULTS: Of 459 patients returning the survey (response rate: 43.5%), 50.1% were non-adherent in claims in month 12 while 20.9% were non-adherent based on the survey. Specificity of the 3-item metric for non-adherence was high (month 12: 0.83). Sensitivity was relatively poor (month 12: 0.25). Month 12 positive and negative predictive values were 0.59 and 0.52, respectively. CONCLUSIONS: A 3-item self-reported measure has high specificity but poor sensitivity for non-adherence versus claims in cardiometabolic disease. Despite this, the tool could help target those needing adherence support, particularly in the absence of claims data.