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The problem of antiretroviral adherence: a self-regulatory model for intervention.

Controlled trials that determine which interventions can significantly improve adherence to combination antiretroviral regimens are urgently needed. Rates of adherence to the regimens are often sub-optimal, and while a variety of factors that are predictive or associated with antiretroviral adherence have been identified, few research findings are reported of interventions that effectively promote adherence and improve health outcomes. Further, the mechanisms by which interventions promote antiretroviral adherence are not well understood. Maximizing adherence and achieving the full potential of the antiretroviral therapies demand multidimensional initiatives that address complex behavioural and biomedical issues. A model drawn from self-regulation theory and empirical data to explain antiretroviral medication adherence is proposed.

Affect↗

The differential impact of PTSD and depression on HIV disease markers and adherence to HAART in people living with HIV.

Despite high rates of comorbidity, research has typically focused on the independent impact of posttraumatic stress disorder (PTSD) and depression symptoms in people living with HIV (PLWH). The present study examined the independent and comorbid influence of PTSD and depression symptoms on medication adherence, CD4 cell counts, and viral load, over the course of 3 months in 57 PLWH (82% men, 54% Caucasian, 44% African American) recruited from a clinic or social service agency. Both PTSD and depressive symptoms predicted lower subsequent adherence. However, only depressive symptoms predicted lower CD4 counts and presence of a detectable viral load. Participants reporting symptoms consistent with diagnostic levels of comorbid PTSD and depression were less likely to adhere to HAART and were more likely to have a detectable viral load. These results highlight the influences of PTSD and depression on adherence and HIV disease markers, and underscore the importance of examining comorbid symptomatology in PLWH.

Adult↗

How can we improve the effectiveness of treatment in elderly hypertensives?

Despite evidence for the benefits of treating hypertension in old age, only a small number of elderly patients have adequate blood pressure control. The reasons are complex and include a combination of factors related to physician, patient adherence to therapy and properties of the antihypertensive drugs. Substantial gaps have been documented between the development and dissemination of recommendations and their implementation in practice. Older patients are more likely to have difficulty with medication adherence. Better compliance achievement among the elderly patients should include a complex strategy. Moreover, physician information strategies must be improved.

Aged↗

A randomized effectiveness trial of brief cognitive-behavioral therapy for depressed adolescents receiving antidepressant medication.

OBJECTIVE: To test a collaborative-care, cognitive-behavioral therapy (CBT) program adjunctive to selective serotonin reuptake inhibitor (SSRI) treatment in HMO pediatric primary care. METHOD: A randomized effectiveness trial comparing a treatment-as-usual (TAU) control condition consisting primarily of SSRI medication delivered outside the experimental protocol (n = 75) versus TAU SSRI plus brief CBT (n = 77). Participants were identified by a recent dispense of SSRI medication followed by telephone screening. Adolescents with a diagnosis of major depressive disorder (n = 152) were enrolled. The CBT program employed cognitive restructuring and/or behavioral activation training. Therapists consulted with prescribing pediatricians to improve medication adherence. RESULTS: Through 1-year follow-up, the authors found CBT advantages on the Short Form-12 Mental Component Scale (p = .04), reductions in TAU outpatient visits (p = .02), and days' supply of all medications (p = .01). No effects were detected for major depressive disorder episodes; a nonsignificant trend favoring CBT was detected on the Center for Epidemiology Depression Scale (p = .07). CONCLUSIONS: The authors detected a weak CBT effect, possibly rendered less significant by the small sample and likely attenuated by the unexpected reduction in SSRI pharmacotherapy in the CBT condition. Small, incremental improvements over monotherapy, such as observed in this study, most likely represent the new norm in adolescent depression treatment research.

Adolescent↗

Motivating HIV positive women to adhere to antiretroviral therapy and risk reduction behavior: the KHARMA Project.

Women comprise the fastest growing group of persons with AIDS. They are often diagnosed later in the disease, when antiretroviral therapy (ART) is strongly indicated. Antiretroviral therapy has transformed the course of HIV/AIDS to a treatable, chronic illness. This article provides a profile of women with HIV/AIDS and describes ART. Selected research related to adherence and motivation is summarized. Psychosocial and economic concerns specific to women, ART, adherence, and motivation are presented. The article reviews challenges for risk reduction behaviors for HIV+ women, such as sexual activity and substance abuse. The authors discuss the Keeping Health and Active with Risk reduction and Medication Adherence (KHARMA) Project, a research project in progress that was designed to promote adherence to both ART and risk reduction behaviors in HIV+ women. The study includes two groups: a motivational group intervention based on motivational interviewing and a health promotion program control group tailored to the needs of HIV+ women. A description of the tailored intervention and project update is included.

Adult↗

Reducing patient drug acquisition costs can lower diabetes health claims.

Concerned about rising prevalence and costs of diabetes among its employees, Pitney Bowes Inc recently revamped its drug benefit design to synergize with ongoing efforts in its disease management and patient education programs. Specifically, based on a predictive model showing that low medication adherence was linked to subsequent increases in healthcare costs in patients with diabetes, the company shifted all diabetes drugs and devices from tier 2 or 3 formulary status to tier 1. The rationale was that reducing patient out-of-pocket costs would eliminate financial barriers to preventive care, and thereby increase adherence, reduce costly complications, and slow the overall rate of rising healthcare costs. This single change in pharmaceutical benefit design immediately made critical brand-name drugs available to most Pitney Bowes employees and their covered dependents for 10% coinsurance, the same coinsurance level as for generic drugs, versus the previous cost share of 25% to 50%. After 2 to 3 years, preliminary results in plan participants with diabetes indicate that medication possession rates have increased significantly, use of fixed-combination drugs has increased (possibly related to easier adherence), average total pharmacy costs have decreased by 7%, and emergency department visits have decreased by 26%. Hospital admission rates, although increasing slightly, remain below the demographically adjusted Medstat benchmark. Overall direct healthcare costs per plan participant with diabetes decreased by 6%. In addition, the rate of increase in overall per-plan-participant health costs at Pitney Bowes has slowed markedly, with net per-plan-participant costs in 2003 at about 4000 dollars per year versus 6500 dollars for the industry benchmark. This recent moderation in overall corporate health costs may be related to these strategic changes in drug benefit design for diabetes, asthma, and hypertension and also to ongoing enhancements in the company's disease management and wellness programs.

Cost Control↗

Hepatitis C and HIV infections: implications for clinical care in injection drug users.

Our objective is to provide a state-of-the-art review on hepatitis C (HCV) and the human immunodeficiency virus (HIV) in injection drug users (IDUs), highlighting important clinical issues. We performed a literature review from the MEDLINE database for research from 1966 to 2003, with an emphasis on recent consensus documents. Of the estimated 15 million illicit drug users in the U.S., approximately 1.0 to 1.5 million inject drugs. IDUs are at significant risk of contracting HCV and HIV, with IDUs accounting for 60% of new HCV cases and 25% of new HIV infections. It is a major risk factor for HCV/HIV coinfection, which significantly impacts on each disorder's progression. It appears that treatment response in IDUs with HCV or HIV is similar to non-IDUs with these viruses and that medication adherence and treatment outcomes are optimized when linked with substance abuse treatment. Providers caring for patients who are or were IDUs must be aware of the management of these diseases and make efforts to integrate their medical care with the treatment of their substance abuse.

HIV Infections↗

Adherence to antiretroviral therapy by human immunodeficiency virus-infected patients.

Poor adherence to antiretroviral treatment regimens has serious consequences for human immunodeficiency virus-infected patients, including failure to prevent viral replication and an increased risk of developing viral resistance. Recent data suggest that the level of medication adherence required for optimal treatment effectiveness is extremely high. Treatment adherence can be measured by use of a variety of methods, including patients' self-reports, pharmacy-based approaches, pill counts, and electronic monitoring. However, these measures of adherence have different strengths and weaknesses in regard to practical application and identifying deficient adherence. All patients receiving antiretroviral therapy require support to insure a high level of treatment adherence, but the evidence about effective interventions is limited. Emerging evidence suggests adherence interventions should employ a multidisciplinary effort involving health care providers, social support networks, family, and friends. Although such programs will require a substantial investment in terms of time and energy, the rewards associated with optimal treatment adherence are worth the effort.

Anti-HIV Agents↗

Adherence to treatment in Swedish HIV-infected patients.

OBJECTIVES: The objectives were to assess the prevalence of adherence to antiretroviral treatment in Swedish human immunodeficiency virus (HIV)-infected patients and to evaluate factors associated with adherence. METHODS: All HIV-treated patients, who attended one of 30 (of a total of 32) Swedish infectious diseases clinics, during 7 months, were asked to complete an anonymous questionnaire containing the 9-item Morisky Medication Adherence Scale (MMAS) and questions about other factors potentially affecting adherence. The summary score of MMAS ranges from 1 to 13, where 13 indicates perfect adherence; patients scoring 11 or above (corresponding to 95% adherence level) were classified as 'adherent'. RESULTS AND DISCUSSION: In total 946 patients participated (response rate 97.5%). The proportion of patients who reported not missing a dose during the day prior to the completion of the questionnaire was 97% and the proportion classified as 'adherent' was 63%. 'Adherent' patients were more likely to have a good relationship with their health care professionals (P < 0.05) and not have problems with drugs or alcohol (P < 0.01). Being older (P < 0.01) and having a shorter time on current treatment (P < 0.01) and on treatment in total (P < 0.05) were factors also associated with good adherence. CONCLUSION: Factors modifiable for interventions by health care professionals are patient-provider relationship, drug or alcohol problems and patients with long treatment periods.

Adult↗

Predicting adherence to prophylactic medication in adolescents with asthma: an application of the ASE-model.

An explanatory framework, referred to as the attitude/social influence/self-efficacy-model (ASE-model), was utilised to explain future self-reported adherence of adolescents to daily inhaled prophylactic asthma medication. The objective was to investigate the long-term influence of these earlier reported cognitive variables and other psychological and medical determinants on self-reported adherence 1 year later. Data were collected, via a questionnaire, from 86 adolescents with asthma (aged 11 through 18 years) recruited from outpatient clinics. Adherence was assessed by asking the patients to give themselves a report mark for adherence. The results of the multiple regression analyses showed that the three major ASE-variables were predictors of self-reported adherence to a moderate degree (R(2)=0.21). Previous self-reported adherence was found to be the best predictor of self-reported adherence to prophylactic asthma medication 1 year later (R(2)=0.45). The results of this study could be useful in the development of interventions to enhance adherence to asthma medication. In future, such interventions should focus on feelings of shame about having asthma and promoting healthy habits, such as adherence to medication.

Adolescent↗

Adherence to antidepressant medications in black and Latino elderly patients.

OBJECTIVE: The purpose of this pilot study was to identify ethnic group differences in nonadherence and to determine predictors of nonadherence to antidepressant medications in older minority-group members. METHODS: Participants were 49 black and 52 Latino subjects over the age of 55 who had been prescribed antidepressant medications within the past 12 months. RESULTS: We found a distinction between intentional nonadherence (e.g., alteration of medication regimen to fit one's needs) and unintentional nonadherence (e.g., forgetfulness/difficulties keeping track of medication regimen). Results suggested that older Latino subjects reported significantly more unintentional nonadherence than older black subjects. However, once other predictors were entered into the model, ethnicity did not remain a significant predictor. No ethnic group differences in intentional nonadherence were suggested. After controlling for ethnicity and medication type, intentional nonadherence was associated with concerns about the side effects of antidepressant medications, the stigma associated with antidepressant medications, and the attribution of lesser importance to antidepressant medications than other medications. Unintentional nonadherence was associated with greater cognitive impairment. CONCLUSIONS: Results suggest that the two ethnic minority groups face similar barriers to adherence to antidepressant medications. Interventions to increase adherence should target the specific type of nonadherence presented by the elderly patients. Some may benefit from memory aids and the assistance of family and friends, others from specific educational interventions about the nature of depression and antidepressant medications.

Aged↗

Does route of administration affect the outcome of TNF antagonist therapy?

The tumor necrosis factor (TNF) antagonists are parenterally administered biologic response modifiers indicated for the management of rheumatoid arthritis. Although infliximab, etanercept, and adalimumab are all members of this class, they differ in route of administration and dosing regimen. In the USA and in Europe, infliximab, in combination with oral methotrexate, is administered intravenously, initially at a dose of 3 mg/kg at weeks 0, 2, and 6, then every 8 weeks thereafter. The US Food and Drug Administration (FDA) has further approved that the dosage can be increased to 10 mg/kg and the doses can be given as often as every 4 weeks to optimize patient outcome (information based on the US package insert dated June 2002). Etanercept and adalimumab are given subcutaneously and can be self-injected. The FDA-approved dose of etanercept is 25 mg twice weekly, and of adalimumab is 40 mg every 2 weeks with methotrexate, or 40 mg alone. Medication adherence, possibly the most important factor in maintaining the benefits of anti-TNF therapy, is influenced by the interaction between the patient and his or her healthcare team, the patient's attitude toward the disease and medication regimen, and the choice of therapy.

Antirheumatic Agents↗

Differences in adherence and motivation to HIV therapy--two independent assessments in 1998 and 2002.

OBJECTIVE: The aim of this study was to compare the level of adherence and motivation in two independent cross-sectional samples of HIV-infected patients conducted in 1998 and 2002, and to investigate the relationship between adherence and motivation. METHOD: Consecutive HIV-infected patients on treatment at a Swedish clinic were asked to complete an anonymous questionnaire. In 1998, 60 patients participated and in 2002, 53 participated. In 2002, the 9-item Morisky Medication Adherence Scale (MMAS) was added to the questionnaire set. MAIN OUTCOME MEASURE: Self-reported adherence and motivation. RESULTS: In 1998, 28.1% of the respondents were considered adherent, while the corresponding proportion was 57.4% in 2002 (P = 0.002). The mean summary score for MMAS was 10.7 in 2002 (13 = perfect adherence). The proportion considered motivated were 22.4% in the 1998 survey and 41.3% in 2002 (P = 0.038). Of the respondents considered motivated in the 2002 survey, 46.7% scored the maximum summary score on the MMAS, while 8.7% of the non-motivated respondents did so (P = 0.016). CONCLUSION: The respondents in 2002 were more adherent and motivated than the respondents in 1998 and a relationship between motivation and adherence was found. The difference in adherence and motivation might be due to a new treatment model at the clinic.

Adult↗

Brand versus generic alendronate: gastrointestinal effects measured by resource utilization.

BACKGROUND: Adverse reactions related to the upper gastrointestinal tract (UGIT) that are associated with generic alendronate formulations may differ from those associated with the brand drug. OBJECTIVE: To test the hypothesis that adverse UGIT effects of alendronate formulations may differ between generic and brand products. METHODS: We conducted a database health resource utilization analysis of UGIT outcomes in patients who started treatment with generic or brand alendronate formulations during 2001-2005. We included 6962 patients who were treated continuously for 3 months with 1 of 4 alendronate formulations: brand 10 mg/day (Merck, Sharpe & Dohme, n = 1418), generic A 10 mg/day (Teva, Israel, n = 650), generic B 10 mg/day (Unipharm, Israel, n = 628), and brand 70 mg/wk (n = 4266). In these patients, who had neither filled a prescription for alendronate nor had any gastrointestinal problems in the year preceding the study, we compared incidence rates of new use of gastric medications (H2-blockers, proton-pump inhibitors, or antacids), gastroenterology visits, endoscopies, and hospital admissions. RESULTS: Incident rate ratios (IRR) for treatment discontinuation were higher with both daily generic products (IRR 1.3; 95% CI 1.04 to 1.63). Adherence (medication possession ratio [MPR] >80%) was better with brand 10 mg/day (IRR 1.19; 95% CI 1.11 to 1.27). All comparisons were adjusted for use of concurrent corticosteroids, nonsteroidal antiinflammatory drugs, and potassium supplements. Hospitalization rates (2.7-3.2%) were similar in all groups. New use of gastric medications (3.4-4.9%) was lower with brand 10 mg/day (IRR 0.71; 95% CI 0.53 to 0.95). Rates of UGIT endoscopy (n = 49) in patients receiving 10 mg were 0.6% (brand), 1.1% (generic A), and 1.6% (generic B), with generic B higher (IRR 2.88; 95% CI 1.14 to 7.29) in the entire cohort, but not among new users (n = 273) of gastric drugs (IRR 2.46; 95% CI 0.55 to 11.05). Endoscopic findings were normal in 22 patients, hiatal hernia with no mucosal lesion was present in 10 patients, and there was mild-to-moderate esophagitis or gastritis in 17 patients; there were no significant differences among the formulations. CONCLUSIONS: We found insufficient evidence to indicate major differences in UGIT adverse effects related to use of daily generic, as compared with brand, alendronates.

Aged↗

A two-way messaging system to enhance antiretroviral adherence.

Failure to adhere to complex antiretroviral regimens can lead to resistance and treatment failure among HIV-positive persons. In this study of the feasibility of an automated two-way messaging system to improve adherence, participants received multiple short daily messages designed to remind, educate, encourage adherence, and solicit responses concerning side effects and self-reported adherence. Twenty-five participants remained in the study for a median of 208 days, receiving 17,440 messages and replying to 14,677 (84%). Participants reported missing one or more doses on 36% of 743 queries and reported medication side effects on 26% of 729 queries. Participants expressed high satisfaction with the messaging system and reported that it helped with medication adherence. The study suggests that it is feasible to use an automated wireless two-way messaging system to communicate with HIV-positive patients over an extended period of time.

Adult↗

Family education for people with schizophrenia in Beijing, China: randomised controlled trial.

BACKGROUND: Much of China lacks well-developed services for people with schizophrenia and their families, and most of the existing services focus on hospitals. There is a need for culturally sensitive family treatments offered by nurses. AIMS: To conduct a longitudinal experimental study examining the effect of patient and family education in a sample of Chinese people with schizophrenia. METHOD: A randomised controlled trial was conducted in a large hospital with a was conducted in a large hospital with a sample of 101 patients with schizophrenia and their families. Data were collected at admission and at discharge, and then at 3 and 9 months after discharge. The intervention group received family education, and data on their knowledge about schizophrenia, symptoms, functioning, psychosocial behaviour, relapse and medication adherence were collected and compared with the control group. RESULTS: There was a significant improvement in knowledge about schizophrenia in the experimental group and a significant difference in symptom scores and functioning at 9 months after discharge. Patients who were nonadherent to medication regimens were more likely to relapse. CONCLUSIONS: Family education on schizophrenia by nurses in China was effective in improving knowledge and promoting improvement in patients' symptoms.

Adolescent↗

Challenges in ambulatory resident education: medication knowledge in disadvantaged patients.

CONTEXT: Medication mismanagement results in 10% of hospitalizations and 50% of therapeutic failures. Little is known about low-income patients' medication knowledge, a group disproportionately affected by chronic disease and often cared for by residents. This study assesses patients' medication knowledge, discrepancies between the patient and chart, and preferences for medication information in the training setting. DESIGN: This cross-sectional study evaluated adults receiving care in two teaching clinics. Patients were asked their medications' names, doses, frequencies, indications, and side effects (SE) and what information they needed to take medications safely. Charts served as a medication reference standard. RESULTS: Most patients were female, nonwhite, had > or = one chronic condition, took a median of five drugs, and saw three different residents in the same clinic. Despite six clinic visits annually, patients could cite only 50% of their medication names, frequencies, and indications, 25% of doses, and 0% of SE, yet they paradoxically responded that SE knowledge was essential for safety. Forty-three percent reported > or = one medication that was undocumented in the chart. There were 84 total discrepant medications of which 63% were prescription only. CONCLUSION: Low-income patients had poor medication knowledge despite good clinic access. Discontinuity of resident providers may contribute to this phenomenon. Poor global knowledge, the large discrepancy between reported and charted medications, and lack of SE knowledge threaten medication adherence, achievement of treatment goals, and patient safety.

Adult↗

Antiretroviral adherence, drug resistance, viral fitness and HIV disease progression: a tangled web is woven.

The clinical goals of HIV treatment are optimally accomplished through consistent high-level adherence to highly active antiretroviral therapy (HAART) and durable suppression of the viral load. However, as a result of the need for lifelong therapy and HIV's prodigious replication rate and error-prone reverse transcriptase, varying amounts of antiretroviral drug resistance are common in treated individuals. Medication adherence is linked to the development of drug resistance, although not by a simple linear relationship. Recent studies have suggested that extensive drug resistance is not a major determinant of HIV disease progression and death. Rather, failure to access care and discontinuation of or non-adherence with therapy are arguably the most important factors associated with HIV disease progression in the HAART era. Other data indicate that continued therapy in the setting of extensive drug resistance and the inability to achieve viral suppression can provide continued clinical benefit. Such benefit may be mediated, at least partially, by reductions in viral fitness associated with drug resistance mutations.

Antiretroviral Therapy, Highly Active↗