Browsing by Subject "Medication Adherence"
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Item Open Access A health literacy pilot intervention to improve medication adherence using Meducation® technology.(Patient education and counseling, 2014-05) Zullig, Leah L; McCant, Felicia; Melnyk, S Dee; Danus, Susanne; Bosworth, Hayden BObjective
To determine whether antihypertensive medication adherence could improve using a Meducation® technology health literacy intervention.Methods
We conducted a six-month feasibility study among patients with cardiovascular disease (CVD) risk factors receiving care from hospital-based primary care clinics. All patients received a personalized Meducation® calendar listing CVD-related medications. We evaluated changes in medication adherence and clinical outcomes at six months.Results
There was a 42% enrollment rate (n=23). Forty percent had low health literacy, defined as less than 9th grade reading level. At three months, self-reported medication adherence improved. At six months, medication possession ratio improved 3.2%. Also, at six months there were decreases in patients' average systolic blood pressure (0.5 mmHg), diastolic blood pressure (1.5 mmHg), and body weight (3.6 pounds) (p>0.05).Conclusions
A health literacy intervention may be a feasible mechanism to improve cardiovascular-related medication adherence and outcomes.Practice implications
Health literacy interventions may improve adherence while requiring relatively few resources to implement.Item Open Access A protocol to evaluate the efficacy, perceptions, and cost of a cholesterol packaging approach to improve medication adherence.(Contemporary clinical trials, 2014-09) Zullig, Leah L; Pathman, Joshua; Melnyk, S Dee; Brown, Jamie N; Sanders, Linda L; Koropchak, Celine; Howard, Teresa; Danus, Susanne; McCant, Felicia; Bosworth, Hayden BPurpose
Elevated low-density lipoprotein cholesterol (LDL-C) is a major modifiable risk factor for cardiovascular disease (CVD), a leading cause of death in the United States. Despite clinical practice guidelines aimed at facilitating LDL-C control, many Veterans do not achieve guideline-recommended LDL-C levels.Methods
We describe a study focused on VA healthcare system users at risk for CVD (i.e., LDL-C level >130 mg/dl and/or <80% cholesterol pill refill adherence in the last 12 months). We are conducting a two and a half year randomized controlled trial (i.e., intervention administered over 12 months) among Veterans with uncontrolled cholesterol receiving care at select VA-affiliated primary care clinics in North Carolina. We anticipate enrolling 250 diverse patients (10% women; 40% African American). Patients are randomized to an educational control group or intervention group. Intervention group participants' medication is provided in special blister packaging labeled for daily use that includes reminders; MeadWestvaco Corporation's pre-filled DosePak® contains standard doses of statins in accordance with the existing prescriptions.Conclusions
Pre-filled blister packaging may provide an inexpensive solution to improve medication adherence. Our study enrolls a diverse sample and provides information about whether an adherence packaging intervention can: 1) improve medication adherence; 2) improve patients' LDL-C levels; 3) be well received by patients and providers; and 4) provide a cost effective solution to improve medication adherence.Item Open Access Adherence to adjuvant endocrine therapy for breast cancer: importance in women with low income.(Journal of women's health (2002), 2015-05) Ursem, Carling J; Bosworth, Hayden B; Shelby, Rebecca A; Hwang, Wenke; Anderson, Roger T; Kimmick, Gretchen GThere are wide disparities in breast cancer-specific survival by patient sociodemographic characteristics. Women of lower income, for instance, have higher relapse and death rates from breast cancer. One possible contributing factor for this disparity is low use of adjuvant endocrine therapy-an extremely efficacious therapy in women with early stage, hormone receptor positive breast cancer, the most common subtype of breast cancer. Alone, adjuvant endocrine therapy decreases breast cancer recurrence by 50% and death by 30%. Data suggest that low use of adjuvant endocrine therapy is a potentially important and modifiable risk factor for poor outcome in low-income breast cancer patients.Item Open Access Adherence to Adjuvant Endocrine Therapy in Insured Black and White Breast Cancer Survivors: Exploring Adherence Measures in Patient Data.(Journal of managed care & specialty pharmacy, 2019-05) Sheppard, Vanessa B; He, Jun; Sutton, Arnethea; Cromwell, Lee; Adunlin, Georges; Salgado, Teresa M; Tolsma, Dennis; Trout, Martha; Robinson, Brandi E; Edmonds, Megan C; Bosworth, Hayden B; Tadesse, Mahlet GBackground
Adjuvant endocrine therapy (AET) is a critical therapy in that it improves survival in women with hormone receptor-positive (HR+) breast cancer (BC), but adherence to AET is suboptimal. The purpose of this study was to fill scientific gaps about predictors of adherence to AET among black and white women diagnosed with BC.Objective
To assess AET adherence in black and white insured women using multiple measures, including one that uses an innovative statistical approach.Methods
Black and white women newly diagnosed with HR+ BC were identified from 2 health maintenance organizations. Pharmacy records captured the type of oral AET prescriptions and all fill dates. Multivariable logistic regression was used to identify predictors of adherence defined in terms of proportion of days covered (PDC; ≥ 80%) and medication gap of ≤ 10 days. A zero-inflated negative binomial (ZINB) regression model was used to identify variables associated with the total number of days of medication gaps.Results
1,925 women met inclusion criteria. 80% were PDC adherent (> 80%); 44% had a medication gap of ≤ 10 days; and 24% had no medication gap days. Race and age were significant in all multivariable models. Black women were less likely to be adherent based on PDC than white women (OR = 0.72, 95% CI = 0.57-0.90, P < 0.01), and they were less likely to have a medication gap of ≤ 10 days (OR = 0.65, 95% CI = 0.54-0.79, P < 0.001). Women aged 25-49 years were less likely to be PDC adherent than women aged 65-93 years (OR = 0.65, 95% CI = 0.48-0.87, P < 0.001). In the ZINB model, women were without their medication for an average of 37 days (SD = 50.5).Conclusions
Racial disparities in adherence to AET in the study highlight a need for interventions among insured women. Using various measures of adherence may help better understand this multidimensional concept. There might be benefits from using both more common dichotomous measures (e.g., PDC) and integrating novel statistical approaches to allow tailoring adherence to patterns within a specific sample.Disclosures
This research was funded by the National Institutes of Health (R01CA154848). It was also supported in part by the NIH-NCI Cancer Center Support Grant P30 CA016059, the Laboratory of Telomere Health P30 CA51008, and the TSA Award No. UL1TR002649 from the National Center for Advancing Translational Sciences. The contents of this study are solely the responsibility of the authors and do not necessarily represent official views of the National Center for Advancing Translational Sciences or the National Institutes of Health. Bosworth reports grants from Sanofi, Otsuka, Johnson & Johnson, and Blue Cross/Blue Shield of NC and consulting fees from Sanofi and Otsuka. The other authors have nothing to disclose. The datasets generated during and/or analyzed during the current study are not publicly available due to privacy reasons but are available from the corresponding author on reasonable request. The author does not own these data. Data use was granted to the author as part of a data use agreement between specific agencies and organizations.Item Open Access Adherence to diabetes guidelines for screening, physical activity and medication and onset of complications and death.(J Diabetes Complications, 2015-11) Chen, Yiqun; Sloan, Frank A; Yashkin, Arseniy PAIMS: Analyze relationships between adherence to guidelines for diabetes care - regular screening; physical activity; and medication - and diabetes complications and mortality. METHODS: Outcomes were onset of congestive heart failure (CHF), stroke, renal failure, moderate complications of lower extremities, lower-limb amputation, proliferative diabetic retinopathy (PDR), and mortality during follow-up. Participants were persons aged 65+ in the Health and Retirement Study (HRS) 2003 Diabetes Study and had Medicare claims in follow-up period (2004-8). RESULTS: Adherence to screening recommendations decreased risks of developing CHF (odds ratio (OR)=0.83; 95% confidence interval (CI): 0.72-0.96), stroke (OR=0.80; 95% CI: 0.68-0.94); renal failure (OR=0. 82; 95% CI: 0.71-0.95); and death (OR=0.86; 95% CI: 0.74-0.99). Adherence to physical activity recommendation reduced risks of stroke (OR=0.64; 95% CI: 0.45-0.90), renal failure (OR=0.71; 95% CI: 0.52-0.97), moderate lower-extremity complications (OR=0.71; 95% CI: 0.51-0.99), having a lower limb amputation (OR=0.31, 95% CI: 0.11-0.85), and death (OR=0.56, 95% CI: 0.41-0.77). Medication adherence was associated with lower risks of PDR (OR=0.35, 95% CI: 0.13-0.93). CONCLUSIONS: Adherence to screening, physical activity and medication guidelines was associated with lower risks of diabetes complications and death. Relative importance of adherence differed among outcome measures.Item Open Access Adherence to Pharmacological Smoking Cessation Interventions: A Literature Review and Synthesis of Correlates and Barriers.(Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2018-09) Pacek, Lauren R; McClernon, F Joseph; Bosworth, Hayden BIntroduction
Efficacious pharmacological interventions for smoking cessation are available, but poor adherence to these treatments may limit these interventions overall impact. To improve adherence to smoking cessation interventions, it is first necessary to identify and understand smoker-level characteristics that drive nonadherence (ie, nonconformance with a provider's recommendation of timing, dosage, or frequency of medication-taking during the prescribed length of time).Methods
We present a literature review of studies examining correlates of, or self-reported reasons for, nonadherence to smoking cessation pharmacotherapies. Studies were identified through PubMed-using MeSH terms, Embase-using Emtree terms, and ISI Web of Science.Results and conclusions
This literature review included 50 studies that examined nonpreventable (eg, sociodemographics) and preventable (eg, forgetfulness) factors associated with adherence to smoking cessation medication and suggestions for overcoming some of the identified barriers. Systematic study of this topic would be facilitated by consistent reporting of adherence and correlates thereof in the literature, development of consistent definitions of medication adherence across studies, utilization of more objective measures of adherence (eg, blood plasma levels vs. self-report) in addition to reliance on self-reported adherence.Implications
This article provides the most comprehensive review to date on correlates of adherence to pharmacological smoking cessation interventions. Challenges and specific gaps in the literature that should be a priority for future research are discussed. Future priorities include additional research, particularly among vulnerable populations of smokers, developing standardized definitions of adherence and methods for measuring adherence, regular assessment of cessation pharmacotherapy adherence in the context of research and clinical practice, and development of novel treatments aimed at preventable barriers to medication adherence.Item Open Access Advances in opioid antagonist treatment for opioid addiction.(The Psychiatric clinics of North America, 2012-06) Ling, Walter; Mooney, Larissa; Wu, Li-TzyItem Open Access Advantages to Using Social-Behavioral Models of Medication Adherence in Research and Practice.(Journal of general internal medicine, 2018-02) Amico, K Rivet; Mugavero, M; Krousel-Wood, Marie A; Bosworth, Hayden B; Merlin, Jessica SAchieving and sustaining high levels of adherence to medication regimens is essential to improving health outcomes, but continues to be a challenge for a sizable proportion of patients. Decades of research suggests that medication adherence is determined by a complex constellation of factors. Social-behavioral science research has focused on creating frameworks that identify which contextual, personal, social, or drug-related factors appear to most influence adherence. Comprehensive models of adherence propose specific structural relationships between these factors that can be used to plan for, implement, and monitor programs that seek to optimize adherence. The use of social-behavioral models offers multiple advantages in both practice and research environments; however, the breadth and depth of these models can deter many from engaging in this important exercise. To promote the use of social-behavioral frameworks and models of adherence, we provide a brief overview of the advantages in using a social-behavioral lens in adherence work, a sampling of models used in HIV medication adherence research that have high generalizability to other conditions, and practical guidance for grounding adherence promotion strategies in evidence informed by social-behavioral science research.Item Open Access An Adaptable Framework for Factors Contributing to Medication Adherence: Results from a Systematic Review of 102 Conceptual Frameworks.(Journal of general internal medicine, 2021-09) Peh, Kai Qi Elizabeth; Kwan, Yu Heng; Goh, Hendra; Ramchandani, Hasna; Phang, Jie Kie; Lim, Zhui Ying; Loh, Dionne Hui Fang; Østbye, Truls; Blalock, Dan V; Yoon, Sungwon; Bosworth, Hayden Barry; Low, Lian Leng; Thumboo, JulianObjective
To summarize the available conceptual models for factors contributing to medication adherence based on the World Health Organization (WHO)'s five dimensions of medication adherence via a systematic review, identify the patient groups described in available conceptual models, and present an adaptable conceptual model that describes the factors contributing to medication adherence in the identified patient groups.Methods
We searched PubMed®, Embase®, CINAHL®, and PsycINFO® for English language articles published from inception until 31 March 2020. Full-text original publications in English that presented theoretical or conceptual models for factors contributing to medication adherence were included. Studies that presented statistical models were excluded. Two authors independently extracted the data.Results
We identified 102 conceptual models, and classified the factors contributing to medication adherence using the WHO's five dimensions of medication adherence, namely patient-related, medication-related, condition-related, healthcare system/healthcare provider-related, and socioeconomic factors. Eight patient groups were identified based on age and disease condition. The most universally addressed factors were patient-related factors. Medication-related, condition-related, healthcare system-related, and socioeconomic factors were represented to various extents depending on the patient group. By systematically examining how the WHO's five dimensions of medication adherence were applied differently across the eight different patient groups, we present a conceptual model that can be adapted to summarize the common factors contributing to medication adherence in different patient groups.Conclusion
Our conceptual models can be utilized as a guide for clinicians and researchers in identifying the facilitators and barriers to medication adherence and developing future interventions to improve medication adherence.Protocol registration
PROSPERO Identifier: CRD42020181316.Item Open Access An international perspective on hospitalized patients with viral community-acquired pneumonia.(European journal of internal medicine, 2019-02) Radovanovic, Dejan; Sotgiu, Giovanni; Jankovic, Mateja; Mahesh, Padukudru Anand; Marcos, Pedro Jorge; Abdalla, Mohamed I; Di Pasquale, Marta Francesca; Gramegna, Andrea; Gramegna, Andrea; Terraneo, Silvia; Blasi, Francesco; Santus, Pierachille; Aliberti, Stefano; Reyes, Luis F; Restrepo, Marcos I; GLIMP Study GroupBackground
Who should be tested for viruses in patients with community acquired pneumonia (CAP), prevalence and risk factors for viral CAP are still debated. We evaluated the frequency of viral testing, virus prevalence, risk factors and treatment coverage with oseltamivir in patients admitted for CAP.Methods
Secondary analysis of GLIMP, an international, multicenter, point-prevalence study of hospitalized adults with CAP. Testing frequency, prevalence of viral CAP and treatment with oseltamivir were assessed among patients who underwent a viral swab. Univariate and multivariate analysis was used to evaluate risk factors.Results
553 (14.9%) patients with CAP underwent nasal swab. Viral CAP was diagnosed in 157 (28.4%) patients. Influenza virus was isolated in 80.9% of cases. Testing frequency and viral CAP prevalence were inhomogeneous across the participating centers. Obesity (OR 1.59, 95%CI: 1.01-2.48; p = 0.043) and need for invasive mechanical ventilation (OR 1.62, 95%CI: 1.02-2.56; p = 0.040) were independently associated with viral CAP. Prevalence of empirical treatment with oseltamivir was 5.1%.Conclusion
In an international scenario, testing frequency for viruses in CAP is very low. The most common cause of viral CAP is Influenza virus. Obesity and need for invasive ventilation represent independent risk factors for viral CAP. Adherence to recommendations for treatment with oseltamivir is poor.Item Open Access Are tuberculosis patients adherent to prescribed treatments in China? Results of a prospective cohort study.(Infect Dis Poverty, 2016-05-05) Lei, Xun; Huang, Ke; Liu, Qin; Jie, Yong-Feng; Tang, Sheng-LanBACKGROUND: Tuberculosis (TB) patients face numerous difficulties adhering to the long-term, rigorous TB treatment regimen. Findings on TB patients' treatment adherence vary across existing literature and official reports. The present study attempted to determine the actual treatment adherence of new TB patients and to identify factors leading to non-adherence. METHODS: A prospective cohort of 481 newly confirmed TB patients from three counties in western China were enrolled during June to December 2012 and was followed until June 2013. Patients who missed at least one dose of drugs or one follow-up re-examination during the treatment course were deemed as non-adherent. Influencing factors were identified using a logistic regression model. RESULTS: A total of 173 (36.0 %) patients experienced non-adherence and the loss to follow-up cases reached 136 (28.2 %). Only 13.9 % of patients took drugs under direct observation, and 60.5 % of patients were supervised by phone calls. Factor analyses suggested that patients who were observed by family members (OR:5.54, 95 % CI:2.87-10.69) and paying monthly service expenses above 450 RMB (OR:2.08, 95 % CI:1.35-3.19) were more likely to be non-adherent, while supervision by home visit (OR:0.06, 95 % CI:0.01-0.28) and phone calls (OR:0.27, 95 % CI:0.17-0.44) were protective factors. CONCLUSIONS: Despite recent efforts, a large proportion of newly confirmed TB patients could not adhere to standard TB treatment, and patients' lost to follow-up was still a serious problem. Poor treatment supervision and heavy financial burden might be the main causes for non-adherence. More needs to be done to enhance treatment supervision policies and financial supports to both health providers and TB patients.Item Open Access Association between perceived life chaos and medication adherence in a postmyocardial infarction population.(Circulation. Cardiovascular quality and outcomes, 2013-11) Zullig, Leah L; Shaw, Ryan J; Crowley, Matthew J; Lindquist, Jennifer; Grambow, Steven C; Peterson, Eric; Shah, Bimal R; Bosworth, Hayden BBackground
The benefits of medication adherence to control cardiovascular disease (CVD) are well defined, yet multiple studies have identified poor adherence. The influence of life chaos on medication adherence is unknown. Because this is a novel application of an instrument, our preliminary objective was to understand patient factors associated with chaos. The main objective was to evaluate the extent to which an instrument designed to measure life chaos is associated with CVD-medication nonadherence.Methods and results
Using baseline data from an ongoing randomized trial to improve postmyocardial infarction (MI) management, multivariable logistic regression identified the association between life chaos and CVD-medication nonadherence. Patients had hypertension and a myocardial infarction in the past 3 years (n=406). Nearly 43% reported CVD-medication nonadherence in the past month. In simple linear regression, the following were associated with higher life chaos: medication nonadherence (β=1.86; 95% confidence interval [CI], 0.96-2.76), female sex (β=1.22; 95% CI [0.22-2.24]), minority race (β=1.72; 95% CI [0.78-2.66]), having less than high school education (β=2.05; 95% CI [0.71-3.39]), low health literacy (β=2.06; 95% CI [0.86-3.26]), and inadequate financial status (β=1.93; 95% CI [0.87-3.00]). Being married (β=-2.09, 95% CI [-3.03 to -1.15]) was associated with lower life chaos. As chaos quartile increased, patients exhibited more nonadherence. In logistic regression, adjusting for sex, race, marital status, employment, education, health literacy, and financial status, a 1-unit life chaos increase was associated with a 7% increase (odds ratio, 1.07; 95% CI [1.02-1.12]) in odds of reporting medication nonadherence.Conclusions
Our results suggest that life chaos may be an important determinant of medication adherence. Life chaos screenings could identify those at risk for nonadherence.Clinical trial registration
URL: http://www.clinicaltrials.gov. Unique identifier: NCT000901277.Item Open Access Associations of Community and Individual Social Determinants of Health With Medication Adherence in Patients With Atrial Fibrillation: A Retrospective Cohort Study.(Journal of the American Heart Association, 2023-04) Boyd, Lisa M; Colavecchia, Anthony Carmine; Townsend, Kevin A; Kmitch, Laura; Broder, Leah; Hegeman-Dingle, Rozelle R; Ateya, Mohammad; Lattimer, Alan; Bosch, Ryan; Alvir, JoseBackground Despite guideline-recommended use of oral anticoagulation (OAC) for stroke prevention in atrial fibrillation (AF), OAC medication adherence among patients with AF in the United States ranges from 47% to 82%. To characterize potential causes of nonadherence, we analyzed associations between community and individual social risk factors and OAC adherence for stroke prevention in AF. Methods and Results A retrospective cohort analysis of patients with AF was conducted using the IQVIA PharMetrics Plus claims data from January 2016 to June 2020, and 3-digit ZIP code-level social risk scores were calculated using American Community Survey and commercial data. Logistic regression models evaluated associations between community social determinants of health, community social risk scores for 5 domains (economic climate, food landscape, housing environment, transportation network, and health literacy), patient characteristics and comorbidities, and 2 adherence outcomes: persistence on OAC for 180 days and proportion of days covered ≥0.80 at 360 days. Of 28 779 patients with AF included in the study, 70.8% of patients were male, 94.6% were commercially insured, and the average patient age was 59.2 years. Multivariable regression found that greater health literacy risk was negatively associated with 180-day persistence (odds ratio [OR]=0.80 [95% CI, 0.76-0.83]) and 360-day proportion of days covered (OR, 0.81 [95% CI, 0.76-0.87]). Patient age and higher AF stroke risk score and AF bleeding risk scores were positively associated with both 180-day persistence and 360-day proportion of days covered. Conclusions Social risk domains, such as health literacy, may affect OAC adherence among patients with AF. Future studies should explore associations between social risk factors and nonadherence with greater geographic granularity.Item Open Access Breast cancer oral anti-cancer medication adherence: a systematic review of psychosocial motivators and barriers.(Breast cancer research and treatment, 2017-09) Lin, Cheryl; Clark, Rachel; Tu, Pikuei; Bosworth, Hayden B; Zullig, Leah LPurpose
In the past decade, there has been an increase in the development and use of oral anti-cancer medications (OAMs), especially for breast cancer-the most prevalent cancer in women. However, adherence rates for OAMs are often suboptimal, leading to lower survival rate, increased risk of recurrence, and higher healthcare costs. Our goal was to identify potentially modifiable psychosocial facilitators and barriers that may be targeted to increase OAM adherence for breast cancer patients.Methods
We systematically searched PubMed for studies published in the U.S. by June 15, 2016 that addressed the following: (1) OAMs for breast cancer; (2) medication adherence; and (3) at least one psychosocial aspect of adherence.Results
Of the 1752 papers screened, 21 articles were included and analyzed. The most commonly reported motivators for adherence are patient-provider relationships (n = 11 studied, 82% reported significant association) and positive views and beliefs of medication (n = 9 studied, 89% reported significant association). We also identified consistent evidence of the impact of depression and emotions, perception of illness, concern of side effects, self-efficacy in medication management and decision making, knowledge of medication, and social support on OAM adherence.Conclusions
Compared to traditional demographic, system, and clinical-related factors that have been well documented in the literature but are not easily changed, these cognitive, psychological, and interpersonal factors are more amendable via intervention and therefore could generate greater benefit in improving patient compliance and health outcomes. As OAMs shift treatment administration responsibility onto patients, continuous provider communication and education on illness and regimen are the keys to supporting patients' medication behavior.Item Open Access Bupropion and Naltrexone in Methamphetamine Use Disorder.(The New England journal of medicine, 2021-01) Trivedi, Madhukar H; Walker, Robrina; Ling, Walter; Dela Cruz, Adriane; Sharma, Gaurav; Carmody, Thomas; Ghitza, Udi E; Wahle, Aimee; Kim, Mora; Shores-Wilson, Kathy; Sparenborg, Steven; Coffin, Phillip; Schmitz, Joy; Wiest, Katharina; Bart, Gavin; Sonne, Susan C; Wakhlu, Sidarth; Rush, A John; Nunes, Edward V; Shoptaw, StevenBackground
The use of naltrexone plus bupropion to treat methamphetamine use disorder has not been well studied.Methods
We conducted this multisite, double-blind, two-stage, placebo-controlled trial with the use of a sequential parallel comparison design to evaluate the efficacy and safety of extended-release injectable naltrexone (380 mg every 3 weeks) plus oral extended-release bupropion (450 mg per day) in adults with moderate or severe methamphetamine use disorder. In the first stage of the trial, participants were randomly assigned in a 0.26:0.74 ratio to receive naltrexone-bupropion or matching injectable and oral placebo for 6 weeks. Those in the placebo group who did not have a response in stage 1 underwent rerandomization in stage 2 and were assigned in a 1:1 ratio to receive naltrexone-bupropion or placebo for an additional 6 weeks. Urine samples were obtained from participants twice weekly. The primary outcome was a response, defined as at least three methamphetamine-negative urine samples out of four samples obtained at the end of stage 1 or stage 2, and the weighted average of the responses in the two stages is reported. The treatment effect was defined as the between-group difference in the overall weighted responses.Results
A total of 403 participants were enrolled in stage 1, and 225 in stage 2. In the first stage, 18 of 109 participants (16.5%) in the naltrexone-bupropion group and 10 of 294 (3.4%) in the placebo group had a response. In the second stage, 13 of 114 (11.4%) in the naltrexone-bupropion group and 2 of 111 (1.8%) in the placebo group had a response. The weighted average response across the two stages was 13.6% with naltrexone-bupropion and 2.5% with placebo, for an overall treatment effect of 11.1 percentage points (Wald z-test statistic, 4.53; P<0.001). Adverse events with naltrexone-bupropion included gastrointestinal disorders, tremor, malaise, hyperhidrosis, and anorexia. Serious adverse events occurred in 8 of 223 participants (3.6%) who received naltrexone-bupropion during the trial.Conclusions
Among adults with methamphetamine use disorder, the response over a period of 12 weeks among participants who received extended-release injectable naltrexone plus oral extended-release bupropion was low but was higher than that among participants who received placebo. (Funded by the National Institute on Drug Abuse and others; ADAPT-2 ClinicalTrials.gov number, NCT03078075.).Item Open Access Characteristics of diabetic patients associated with achieving and maintaining blood pressure targets in the Adherence and Intensification of Medications program.(Chronic illness, 2014-03) Klamerus, Mandi L; Kerr, Eve A; Bosworth, Hayden B; Schmittdiel, Julie A; Heisler, MicheleObjectives
To determine patient characteristics associated with achieving and sustaining blood pressure (BP) targets in the Adherence and Intensification of Medications program, a program led by pharmacists trained in motivational interviewing and authorized to make BP medication changes.Methods
We conducted a retrospective cohort study of patients with diabetes and persistent hypertension in Kaiser Permanente and the Department of Veterans Affairs. Using two-level logistic regression, baseline survey data from 458 program participants were examined to determine patient characteristics associated with (1) discharge from the program with a target BP (short-term success) and (2) maintenance of the target BP over a nine-month period (long-term success).Results
In multivariable analyses, patients who screened positive for depression or had a higher baseline systolic BP were less likely to achieve short-term success (adjusted odds ratio (AOR) 0.42 [95% confidence interval (CI): 0.19-0.93], p = 0.03; AOR 0.94 [0.91-0.97], p < 0.01; respectively). Patients who reported at baseline one or more barriers to medication adherence were less likely to achieve long-term success (AOR 0.50 [0.26-0.94], p = 0.03).Conclusions
Although almost 90% of patients achieved short-term success, only 28% achieved long-term success. Baseline barriers to adherence were associated with lack of long-term success and could be the target of maintenance programs for patients who achieve short-term success.Item Open Access Co-occurring reasons for medication nonadherence within subgroups of patients with hyperlipidemia.(Journal of behavioral medicine, 2019-04) Blalock, Dan V; Bosworth, Hayden B; Reeve, Bryce B; Voils, Corrine IMedication nonadherence is a significant clinical problem among individuals taking statins. Poor adherence is often attributable to several reasons, yet most adherence interventions target a single reason. Baseline data were examined from a randomized clinical trial of 236 patients with hyperlipidemia. A latent class analysis was then performed on patients reporting any nonadherence (n = 109). A 4-class solution provided the most optimal fit and differentiation of classes. Class 1 (N = 59, 54%) included patients who reported occasionally forgetting. Class 2 (N = 16, 14%) represented patients who were concerned about side effects. Class 3 (N = 17, 16%) represented patients who reported out-of-routine life events as contributing to nonadherence. Class 4 (N = 17, 16%) represented patients who endorsed a large number reasons indiscriminately. Class membership was almost uniformly unrelated to any patient demographic factors or treatment arm. Each cluster of reasons defining these patients may be best addressed through different intervention strategies.Item Open Access Countering clinical inertia in lipid management: Expert workshop summary.(American heart journal, 2018-12) Zullig, Leah L; Egbuonu-Davis, Lisa; Trasy, Anjali; Oshotse, Christiana; Goldstein, Karen M; Bosworth, Hayden BItem Open Access Development of an Item Bank to Measure Medication Adherence: Systematic Review.(Journal of medical Internet research, 2020-10) Kwan, Yu Heng; Oo, Livia Jia Yi; Loh, Dionne Hui Fang; Phang, Jie Kie; Weng, Si Dun; Blalock, Dan V; Chew, Eng Hui; Yap, Kai Zhen; Tan, Corrinne Yong Koon; Yoon, Sungwon; Fong, Warren; Østbye, Truls; Low, Lian Leng; Bosworth, Hayden Barry; Thumboo, JulianBackground
Medication adherence is important in managing the progression of chronic diseases. A promising approach to reduce cognitive burden when measuring medication adherence lies in the use of computer-adaptive tests (CATs) or in the development of shorter patient-reported outcome measures (PROMs). However, the lack of an item bank currently hampers this progress.Objective
We aim to develop an item bank to measure general medication adherence.Methods
Using the preferred reporting items for systematic review and meta-analysis (PRISMA), articles published before October 2019 were retrieved from PubMed, Embase, CINAHL, the Cochrane Library, and Web of Science. Items from existing PROMs were classified and selected ("binned" and "winnowed") according to standards published by the Patient-Reported Outcomes Measurement Information System (PROMIS) Cooperative Group.Results
A total of 126 unique PROMs were identified from 213 studies in 48 countries. Items from the literature review (47 PROMs with 579 items for which permission has been obtained) underwent binning and winnowing. This resulted in 421 candidate items (77 extent of adherence and 344 reasons for adherence).Conclusions
We developed an item bank for measuring general medication adherence using items from validated PROMs. This will allow researchers to create new PROMs from selected items and provide the foundation to develop CATs.Item Open Access Do the benefits of participation in a hypertension self-management trial persist after patients resume usual care?(Circulation. Cardiovascular quality and outcomes, 2014-03) Maciejewski, Matthew L; Bosworth, Hayden B; Olsen, Maren K; Smith, Valerie A; Edelman, David; Powers, Benjamin J; Kaufman, Miriam A; Oddone, Eugene Z; Jackson, George LBackground
Hypertension self-management has been shown to improve systolic blood pressure (BP) control, but longer-term economic and clinical impacts are unknown. The purpose of this article is to examine clinical and economic outcomes 18 months after completion of a hypertension self-management trial.Methods and results
This study is a follow-up analysis of an 18-month, 4-arm, hypertension self-management trial of 591 veterans with hypertension who were randomized to usual care or 1 of 3 interventions. Clinic-derived systolic blood pressure obtained before, during, and after the trial were estimated using linear mixed models. Inpatient admissions, outpatient expenditures, and total expenditures were estimated using generalized estimating equations. The 3 telephone-based interventions were nurse-administered health behavior promotion, provider-administered medication adjustments based on hypertension treatment guidelines, or a combination of both. Intervention calls were triggered by home BP values transmitted via telemonitoring devices. Clinical and economic outcomes were examined 12 months before, 18 months during, and 18 months after trial completion. Compared with usual care, patients randomized to the combined arm had greater improvement in proportion of BP control during and after the 18-month trial and estimated proportion of BP control improved 18 months after trial completion for patients in the behavioral and medication management arms. Among the patients with inadequate baseline BP control, estimated mean systolic BP was significantly lower in the combined arm as compared with usual care during and after the 18-month trial. Utilization and expenditure trends were similar for patients in all 4 arms.Conclusions
Behavioral and medication management can generate systolic BP improvements that are sustained 18 months after trial completion.Clinical trial registration
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00237692.