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Electronic Nudges to Increase Influenza Vaccination in Immunosuppressed Adults Across the Age Spectrum: A Pooled Analysis of 2 Nationwide Randomized Trials.

BACKGROUND: Immunosuppressed individuals face higher risk of severe influenza complications, yet vaccination coverage remains low. We aimed to assess the effect of electronic letter-based nudges on influenza vaccination uptake by immunosuppression status. METHODS: We performed a participant-level pooled analysis of 2 methodologically harmonized, nationwide, pragmatic randomized clinical trials during the 2023-2024 influenza season. Adults aged &#x2265;65 years (NUDGE-FLU-2) and adults aged 18-64 years with chronic conditions (NUDGE-FLU-CHRONIC) were included, with immunosuppression defined by an immunosuppressive diagnosis or a filled prescription for immunosuppressive therapy. Participants were randomized in a 2.45:1:1:1:1:1:1 ratio to usual care or 1 of 6 electronic letter interventions. The primary outcome was receipt of influenza vaccination by 1 January 2024 ascertained from nationwide administrative health registries. Effect modification by immunosuppression status was assessed using binomial regression. RESULTS: Among 1 181 254 participants (mean age 67 years; 73 830 [6.3%] immunosuppressed), 66.1% were vaccinated. Any letter increased vaccine uptake compared with usual care (absolute difference, 2.79% points; 95% confidence interval [CI], 2.60-2.98; P < .001), with greater effect among immunosuppressed individuals (+4.12 vs +2.70% points; Pinteraction = .002). In younger adults with chronic conditions, letter-based nudges increased vaccination rates by 11.7% points overall and by 13.3% points among those with immunosuppression (Pinteraction = .007). Among immunosuppressed individuals, nudging effects appeared greater for those with immunosuppressive conditions than for those receiving immunosuppressive treatment. CONCLUSIONS: Electronic letter-based nudges increased influenza vaccination rates, with greater benefit among immunosuppressed individuals. These findings support implementation of low-cost, letter-based nudging strategies to improve vaccine uptake in this high-risk population. Clinical Trials Registration. NCT06030726 and NCT06030739.

Adolescent↗

Evaluation of excessive anticoagulation in a group model health maintenance organization.

BACKGROUND: The fourth American College of Chest Physicians Consensus Conference on Antithrombotic Therapy recently published guidelines that included recommendations regarding the management of excessive anticoagulation. Limited data are available to support these recommendations. OBJECTIVES: To assess management and outcomes of excessive anticoagulation in a group model health maintenance organization, compare management with the published guidelines, and analyze the cost of treatment strategies. METHODS: A search of computerized laboratory information identified patients with an international normalized ratio (INR) of greater than 6.0 during the 9-month study. Pertinent data were collected through a retrospective medical record review. Information was concurrently collected for cost analyses. RESULTS: The analysis included 301 episodes of excessive anticoagulation among 248 patients. Most (83%) episodes of elevated INRs were managed conservatively by a temporary discontinuation of warfarin sodium therapy until the INR was in a therapeutic range. Conservative management resulted in no sequelae in 212 (85.1%) of 249 episodes. Two episodes (0.8%) of major bleeding evolved in patients managed conservatively. No sequelae were documented in 23 (44%) of 52 episodes of phytonadione (vitamin K1) administration. Sixteen (31%) episodes of major bleeding were documented, but bleeding occurred before phytonadione administration in all cases. Administering phytonadione resulted in hospital admission for 3 patients--2 (3.8%) because of thromboembolism and 1 (1.9%) for the administration of heparin sodium. Cost-effectiveness analysis determined that treatment with phytonadione is 7 times more costly than conservative management when INRs are between 6.0 and 10.0. CONCLUSIONS: Most episodes of excessive anticoagulation were not managed per consensus guidelines. The higher the INR, the more likely were interventions to adhere to the guidelines. Administering phytonadione to patients with a moderate elevation of INRs (6.0-10.0) may be unnecessary. Based on this study, conservative management is a viable option.

Aged↗

Reasons for pediatrician nonadherence to asthma guidelines.

BACKGROUND: The 1997 National Heart, Lung, and Blood Institute (NHLBI) asthma guidelines include recommendations on how to improve the quality of care for asthma. OBJECTIVE: To identify barriers to physician adherence to the NHLBI guidelines. DESIGN: Cross-sectional survey. PARTICIPANTS: A national random sample of 829 primary care pediatricians. MAIN OUTCOME MEASURES: Self-reported adherence to 4 components of the NHLBI guidelines (steroid prescription, instructing peak flow meter use, screening and counseling patients with asthma for smoking, and screening and counseling parents for smoking). We also collected information on physician demographics, practice characteristics, and possible barriers to adherence. We defined adherence as following a guideline component more than 90% of the time. RESULTS: The response rate was 55% (456/829). Most of the responding pediatricians were aware of the guidelines (88%) and reported having access to a copy of the guidelines (81%). Self-reported rates of adherence were between 39% and 53% for the guideline components. After controlling for demographics and other barriers, we found that nonadherence was associated with specific barriers for each guideline component: for corticosteroid prescription, lack of agreement (odds ratio [OR], 6.8; 95% confidence interval [CI], 3.2-14.4); for peak flow meter use, lack of self-efficacy (OR, 3.4; 95% CI, 1.9-6.1) and lack of outcome expectancy (OR, 4.7; 95% CI, 2.5-8.9); and for screening and counseling of patients and parents for smoking, lack of self-efficacy (OR, 3.8; 95% CI, 1.7-6.2 and OR, 2.8; 95% CI, 1.3-5.9, respectively). CONCLUSIONS: Although pediatricians in this sample were aware of the NHLBI guidelines, a variety of barriers precluded their successful use. To improve NHLBI guideline adherence, tailored interventions that address the barriers characteristic of a given guideline component need to be implemented.

Adrenal Cortex Hormones↗

Adherence with treatment regimens among adult rheumatoid arthritis patients: current status and future directions.

This paper reviews the literature concerning adult rheumatoid arthritis (RA) patients' adherence with medication regimens, home exercise, splint usage, and self-management of pain. There are few reliable data regarding the prevalence of adherence problems or the attributes of patients, health-care providers, and environments that may influence adherence. In addition, little effort has been devoted to the development of interventions that may enhance adherence. Future investigators should attend to (1) the development of reliable and valid measures of adherence; (2) longitudinal studies of changes in adherence as a function of disease activity, treatment methods, and third-party reimbursements for services; (3) observational studies of patient-provider interactions and their influence on adherence; and (4) interventions to enhance adherence that are based on a self-regulation model.

Arthritis, Rheumatoid↗

Just keep taking the tablets: adherence to antidepressant treatment in older people in primary care.

BACKGROUND: poor adherence to antidepressant medication may account for a significant proportion of treatment failures. Adherence levels and factors associated with adherence have not previously been studied in older people. OBJECTIVES: to report the prevalence and correlates of adherence to antidepressants in people > or = 65 years of age in a primary care setting. METHOD: sixty-seven patients currently being prescribed antidepressants from a single rural general practice were assessed using a range of questionnaires measuring adherence to antidepressants, severity of depression, specific health education about antidepressants, level of side-effects, insight, positive and negatives beliefs about medication in general and antidepressants in particular, level of intellectual functioning (past and present), a past history of recovery from depression, type of antidepressant, complexity of prescriptions, age and living arrangements. RESULTS: forty-five participants (67.2%) were fully adherent; seven (10.4%) mostly adherent, three (4.5%) adhered sometimes, three rarely and nine (13.4%) never. Backwards linear regression found that adherence increased with information given and cognitive impairment and decreased with concerns about taking antidepressants and severity of side-effects. CONCLUSIONS: non-adherence to antidepressant medication is a significant problem in older patients. Our study probably overestimated adherence as it was self-report, which usually overestimates adherence and the refusals are more likely to have been people not taking tablets but still found nearly one third of the patients were non-adherent. An intervention comprising education, eliciting and addressing specific concerns about antidepressant medication and using medication, which minimises side effects, may be helpful.

Aged↗

Effects of Dynamic Neck Sensorimotor Biofeedback Training in Individuals With Mechanical Neck Pain: A Pilot Randomized Controlled Trial.

Mechanical neck pain (MNP) is commonly accompanied by pain-related functional limitations, sensorimotor disturbances, and fear of movement, which together may contribute to persistent disability. This preliminary randomized controlled trial study investigated the short-term effects of dynamic neck sensorimotor-based biofeedback training in individuals with MNP. 20 MNP patients from outpatient clinics were assigned to a biofeedback training group or a control group. The training group underwent dynamic biofeedback exercises twice weekly for 2&#xa0;weeks, whereas the control group performed repeated cervical movements without biofeedback. Outcomes included cervical kinematics as repositioning errors (RPE), movement units (MU), maximal range of motion (ROM), and subjective measures, including pain intensity, Neck Disability Index (NDI), and Fear-Avoidance Beliefs Questionnaire (FABQ). All participants completed post-intervention assessments; adherence in the training group was 100%, with no missing data and no adverse events reported. Within the biofeedback training group, participants receiving biofeedback training demonstrated greater improvements in cervical repositioning accuracy during flexion (51.95%, p&#xa0;=&#xa0;0.04) and extension (46.67%, p&#xa0;=&#xa0;0.02), along with reductions in fear-avoidance beliefs related to physical activity and work (p&#xa0;<&#xa0;0.05); these changes were less apparent in the active control group. Exploratory regression analyses suggested associations between improvements in repositioning accuracy and pain reduction, and between increased cervical range of motion and improvements in fear-avoidance beliefs related to physical activity. These pilot findings suggest that dynamic sensorimotor biofeedback training may improve proprioceptive acuity and fear-avoidance beliefs in individuals with MNP, supporting further evaluation in an adequately powered randomized trial.

Humans↗

Optimizing smoking cessation pharmacotherapy and counseling for adult primary care patients: a factorial randomized controlled trial.

BACKGROUND: Even with the most effective smoking cessation pharmacotherapies (i.e., varenicline or combination nicotine replacement [C-NRT]), the majority of people ultimately return to smoking. This research explored how to optimize the use of varenicline and C-NRT to promote smoking cessation. METHODS: Primary care patients participated in a 2x2x2x2 factorial experiment that evaluated 4 factors: 1) Medication Type (Varenicline vs. C-NRT [patch&#xa0;+&#xa0;mini-lozenge]), 2) Preparation (pre-quit) Medication (4 Weeks vs. Standard); 3) Medication Duration (Extended [24&#xa0;weeks] vs. Standard [12&#xa0;weeks]); and 4) Counseling Type (Cessation Counseling [4 sessions] vs. Referral Support [2 sessions focused on use of referral resources]). This study was discontinued prior to reaching the proposed sample size (N&#xa0;=&#xa0;608) due to pandemic-related budgetary constraints. RESULTS: Participants (N&#xa0;=&#xa0;496) were 55% women and 45.6% Black individuals. There were no statistically significant main effects of the 4 factors on abstinence at 12, 26 or 52&#xa0;weeks. There was a 3-way interaction between Medication Type, Preparation Medication, and Counseling Type (p&#xa0;=&#xa0;0.04) predicting the primary outcome of biochemically confirmed abstinence at 52&#xa0;weeks; cessation counseling vs. referral support improved varenicline quit rates when 4&#xa0;weeks versus 1&#xa0;week of pre-quit medication was offered. For C-NRT, counseling type did not significantly improve quit rates regardless of the use of preparation medication. CONCLUSIONS: There was no robust evidence that enhanced pre-quit or extended duration of varenicline or C-NRT increased abstinence rates. More intensive counseling may support cessation for different pharmacotherapy regimens. Given the lack of consistent findings, this research should be viewed as exploratory to guide future research.

Humans↗

Electronic monitoring and counseling to improve medication adherence.

Electronic caps, pill caps that record the date and time of pill bottle opening provide an objective measure of adherence to prescribed medication. A promising intervention to improve adherence, cue-dose training, involves reviewing patients' pill cap-generated reports concerning their medication-taking and offering individualized recommendations for remembering to take medications at specific times of day. In this preliminary study, 79 patients prescribed the antihyperglycemic medication metformin had adherence assessed during a 4-week baseline period. Adherence, defined as proportion of prescribed doses taken within a predetermined 4-h window, was measured using electronic MEMS caps. Those who had less than 80% baseline adherence (n = 33) were randomly assigned to either receive 4 months of cue-dose training (n = 16) or to a control group (n = 17). Cue-dose training was associated with significantly better adherence to metformin (mean improvement of 15%). The effects of cue-dose training on adherence to other antihyperglycemic medication did not reach statistical significance. Glycosylated hemoglobin (a measure of blood sugar control) did not differ between groups. Data from nine patients who reviewed pill cap-generated data with their primary care providers suggested that both patients and providers found the discussion moderately helpful and not at all uncomfortable.

Cues↗

Adherence to antiretroviral therapy: an empirical test of the information-motivation-behavioral skills model.

Consistent and nearly perfect adherence is considered an essential requirement for HIV-positive patients on antiretroviral therapy (ART) to fully realize its life-extending benefits. The current study evaluated a comprehensive model of ART adherence--the information-motivation-behavioral skills (IMB) model. This model views adherence behavior as a function of the interrelations between adherence-related information, motivation, and behavioral skills. It hypothesizes that adherence-related information and motivation work through adherence-related behavioral skills to affect the initiation and maintenance of optimal ART adherence. In a series of structural equation models, the IMB model's critical constructs and assumptions were evaluated with a sample of 100 HIV-positive patients in clinical care. Across all analyses, the authors found support for the assumptions of the IMB model of ART adherence. Consistent with the model, adherence-related information and motivation related significantly to adherence-related behavioral skills, and behavioral skills related significantly to self-reported optimal adherence. Further, as predicted, the effects of information and motivation on self-reported adherence were mediated by adherence-related behavioral skills. Current study results are explored, and implications for adherence promotion interventions based on the model are discussed.

Adult↗

An information-motivation-behavioral skills model of adherence to antiretroviral therapy.

HIV-positive persons who do not maintain consistently high levels of adherence to often complex and toxic highly active antiretroviral therapy (HAART) regimens may experience therapeutic failure and deterioration of health status and may develop multidrug-resistant HIV that can be transmitted to uninfected others. The current analysis conceptualizes social and psychological determinants of adherence to HAART among HIV-positive individuals. The authors propose an information-motivation-behavioral skills (IMB) model of HAART adherence that assumes that adherence-related information, motivation, and behavioral skills are fundamental determinants of adherence to HAART. According to the model, adherence-related information and motivation work through adherence-related behavioral skills to affect adherence to HAART. Empirical support for the IMB model of adherence is presented, and its application in adherence-promotion intervention efforts is discussed.

Anti-Retroviral Agents↗

Frequent Hemodialysis Network (FHN) randomized trials: study design.

Observational studies suggest improvements with frequent hemodialysis (HD), but its true efficacy and safety remain uncertain. The Frequent Hemodialysis Network Trials Group is conducting two multicenter randomized trials of 250 subjects each, comparing conventional three times weekly HD with (1) in-center daily HD and (2) home nocturnal HD. Daily HD will be delivered for 1.5-2.75 h, 6 days/week, with target eK(t)/V(n) > or = 0.9/session, whereas nocturnal HD will be delivered for > or = 6 h, 6 nights/week, with target stdK(t)/V of > or = 4.0/week. Subjects will be followed for 1 year. The composite of mortality with the 12-month change in (i) left ventricular mass index (LVMI) by magnetic resonance imaging, and (ii) SF-36 RAND Physical Health Composite (PHC) are specified as co-primary outcomes. The seven main secondary outcomes are between group comparisons of: change in LVMI, change in PHC, change in Beck Depression Inventory score, change in Trail Making Test B score, change in pre-HD serum albumin, change in pre-HD serum phosphorus, and rates of non-access hospitalization or death. Changes in blood pressure and erythropoiesis will also be assessed. Safety outcomes will focus on vascular access complications and burden of treatment. Data will be obtained on the cost of delivering frequent HD compared to conventional HD. Efforts will be made to reduce bias, including blinding assessment of subjective outcomes. Because no large-scale randomized trials of frequent HD have been previously conducted, the first year has been designated a Vanguard Phase, during which feasibility of randomization, ability to deliver the interventions, and adherence will be evaluated.

Clinical Protocols↗

Intense tai chi exercise training and fall occurrences in older, transitionally frail adults: a randomized, controlled trial.

OBJECTIVES: To determine whether an intense tai chi (TC) exercise program could reduce the risk of falls more than a wellness education (WE) program in older adults meeting criteria for transitioning to frailty. DESIGN: Randomized, controlled trial of 48 weeks duration. SETTING: Twenty congregate living facilities in the greater Atlanta area. PARTICIPANTS: Sample of 291 women and 20 men aged 70 to 97. MEASUREMENTS: Demographics, time to first fall and all subsequent falls, functional measures, Sickness Impact Profile, Centers for Epidemiologic Studies-Depression Scale, Activities-specific Balance Confidence Scale, Falls Efficacy Scales, and adherence to interventions. RESULTS: The risk ratio (RR) of falling was not statistically different in the TC group and the WE group (RR=0.75, 95% confidence interval (CI)=0.52-1.08), P=.13). Over the 48 weeks of intervention, 46% (n=132) of the participants did not fall; the percentage of participants that fell at least once was 47.6% for the TC group and 60.3% for the WE group. CONCLUSION: TC did not reduce the RR of falling in transitionally frail, older adults, but the direction of effect observed in this study, together with positive findings seen previously in more-robust older adults, suggests that TC may be clinically important and should be evaluated further in this high-risk population.

Accidental Falls↗

Nonadherence to antiretroviral therapy in HIV-positive patients in Costa Rica.

A cross-sectional study was performed among seropositive individuals who sought HIV treatment at an outpatient clinic in San Jose, Costa Rica, to determine the prevalence, predictors, and reasons for nonadherence to antiretroviral. A structured, face-to-face interview was administered to 88 patients. The primary outcome of adherence was measured as taking 100% of medications within 3 days prior to interview. A number of risk factors, including demographic information, HIV knowledge, logistics of the regimen, and management skills were assessed. Statistical analyses included logistic regression. Eighty-five percent of patients took 100% of their medications in the last 3 days. Factors that were correlated with nonadherence included difficulty in finding transportation to the clinic (odds ratio [OR] = 6.3, p = 0.01), not laying pills out as a management skill (OR = 9.9, p = 0.01), and prescription instructions to take medication on an empty stomach (OR = 6.7, p = 0.03). HIV-positive patients in this Costa Rican sample were fairly adherent to their drug regimens. To increase adherence among non-adherent individuals, interventions that increase access in remote areas and help people manage their regimens may be beneficial.

Adolescent↗

Prevalence and correlates of nonadherence to antiretroviral therapy in a population of HIV patients using Medication Event Monitoring System.

Nonadherence to antiretroviral therapy (ART) jeopardizes good clinical outcome in people living with HIV. In a single-center prospective study, prevalence and correlates of nonadherence were investigated in 43 patients on ART. Nonadherence was assessed using Medication Event Monitoring System (MEMS), self-report and collateral report of treating physicians. Based on MEMS data, median taking adherence, dosing adherence, and timing adherence was 98% (interquartile range [IQR] = 5.3), 91.5% (IQR = 18), and 86% (IQR = 31.5), respectively. The median number of drug holidays per 100 days was 0.8 (IQR = 4.8). The prevalence of nonadherence measured by MEMS was 40%. Self-reported nonadherence and collateral report of nonadherence by physicians varied from 5% to 41% and 24% to 28%, respectively. Patients were categorized as adherent or nonadherent based on a clinically validated algorithm derived from MEMS parameters. Nonadherent patients used significantly more escaping coping strategies (p = 0.003) and planned problem solving strategies (p = 0.049), were prescribed significantly more antiretroviral medications (p = 0.02) and were significantly longer on ART (p = 0.04) than adherent patients. Identified correlates of nonadherence may help clinicians in detecting patients with HIV at risk for nonadherence and can support the development of adherence enhancing interventions.

Adaptation, Psychological↗

Pediatric adherence as a multidimensional and dynamic construct, involving a triadic partnership.

OBJECTIVE: The aim of this paper is to integrate and draw attention to research findings that support our conceptualization of adherence as being multidimensional, dynamic, and involving a triadic partnership. METHODS: A review of relevant articles found in Medline, PsychLit, and reference lists provided in pertinent articles was performed. RESULTS: Significant progress has been made in identifying disease-related and psychosocial correlates of pediatric adherence and in developing intervention programs to promote adherence. Both lines of work have proceeded without a unifying framework for conceptualizing and measuring pediatric adherence. We offer a model that views adherence as comprising three defining aspects: (a) multidimensional, in support of the complexity and interrelatedness of treatment components, (b) a triadic partnership, as in mutually influential exchanges within and among the caregiver-medical team, child-medical team, and caregiver-child relationships, and (c) dynamic in relation to the notion of changes in developmental adaptive capacity, contextual characteristics, and disease course. CONCLUSIONS: Much work has yet to be done to validate, refine, and extend our model of adherence. Recommendations are offered for assessing each defining aspect, and a group-based methodology that accommodates longitudinal, prospective data is described.

Caregivers↗

A qualitative investigation of adherence issues for men who are HIV positive.

People who are HIV-positive and people who have been diagnosed with AIDS have new hope in the form of antiretroviral medications. However, many social workers remain unaware of the rigors of this treatment regimen and the difficulties it presents. This article presents the results of a qualitative study of HIV-positive individuals who have struggled with the adherence issues endemic to antiretroviral treatment and seeks to give voice to their experiences. The article seeks to educate social workers about antiretroviral treatment for HIV, importance of adherence, and intervention strategies.

Adult↗

The use of non face-to-face communication to enhance preventive strategies.

Multiple studies have demonstrated disappointingly low rates of persistence with therapies recommended to reduce cardiovascular risk. Non face-to-face communication has been employed as a strategy to increase the rate of adherence with both pharmacologic and lifestyle modification risk-reduction measures. In addition to the impact on adherence, these interventions have the potential to affect intermediate measures, such as increased access to care, increased patient satisfaction, and decreased resource utilization. Improvement in clinical outcomes is the ultimate measure of success of this intervention.

Cardiovascular Diseases↗