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Medication nonadherence and the outcomes of patients with quiescent ulcerative colitis.

PURPOSE: We conducted a prospective study to determine the effects of nonadherence with mesalamine among patients with quiescent ulcerative colitis. METHODS: We followed a cohort of 99 consecutive patients who had ulcerative colitis in remission for more than 6 months and who were taking maintenance mesalamine. Medication adherence rates were calculated based on pharmacy records and a validated formula. Nonadherence was defined as refilling less than 80% of prescribed medication. Patients were followed prospectively and evaluated either in clinic or via telephone at 6, 12, and 24 months. The primary outcome was clinical recurrence of ulcerative colitis. Proportional hazards models were used to adjust for confounders. RESULTS: At 6 months, 12 patients (12%) had clinical recurrence of disease symptoms, all of whom were nonadherent with medication. At 12 months, 19 of 86 patients had recurrent disease, 13 (68%) of whom were nonadherent. Patients who were not adherent with medication had more than a fivefold greater risk of recurrence than adherent patients (hazard ratio = 5.5; 95% confidence interval: 2.3 to 13; P < 0.001). CONCLUSION: Nonadherence with medication increases the risk of clinical relapse among patients with quiescent ulcerative colitis. Future research should be directed at behavioral interventions to improve adherence.

Adolescent↗

Frequency and impact of nonadherence to immunosuppressants after renal transplantation: a systematic review.

Nonadherence to immunosuppressants is recognized to occur after renal transplantation, but the size of its impact on transplant survival is not known. A systematic literature search identified 325 studies (in 324 articles) published from 1980 to 2001 reporting the frequency and impact of nonadherence in adult renal transplant recipients. Thirty-six studies meeting the inclusion criteria for further review were grouped into cross-sectional and cohort studies and case series. Meta-analysis was used to estimate the size of the impact of nonadherence on graft failure. Only two studies measured adherence using electronic monitoring, which is currently thought to be the most accurate measure. Cross-sectional studies (n=15) tended to rely on self-report questionnaires, but these were poorly described; a median (interquartile range) of 22% (18%-26%) of recipients were nonadherent. Cohort studies (n=10) indicated that nonadherence contributes substantially to graft loss; a median (interquartile range) of 36% (14%-65%) of graft losses were associated with prior nonadherence. Meta-analysis of these studies showed that the odds of graft failure increased sevenfold (95% confidence interval, 4%-12%) in nonadherent subjects compared with adherent subjects. Standardized methods of assessing adherence in clinical populations need to be developed, and future studies should attempt to identify the level of adherence that increases the risk of graft failure. However, this review shows nonadherence to be common and to have a large impact on transplant survival. Therefore, significant improvements in graft survival could be expected from effective interventions to improve adherence.

Graft Rejection↗

[Relevance of treatment compliance in heart failure].

It is recognized that the irregularity in therapeutic compliance is one of the main unstabilizing factors leading to hospitalization in patients with heart failure (HF). In this review, we specifically deal with the Pharmacological Therapeutic Adherence (PTA) in HF patients, and especially with the adherence problems related to those drugs which have been shown to improve the prognosis of the disease. The impact of a deficient PTA (DPTA) jeopardizes the efficiency of the new neurohormonal inhibitor drugs which have proven benefit in wide and expensive clinical trials. It is necessary to have more information about PTA, to develop skills and methods to identify noncompliant patients and to practically improve those actions which have shown some positive effect on DPTA. Some DPTA-related problems owe to inappropriate therapeutic schemes, adverse effects, social deprivation, scarce interaction with the physician and an inadequate health education. Uninformed patients use to believe that they must take the medicines only when they feel sick and have symptoms, yet they believe that drugs can be withdrawn when they feel better. Different pharmacological groups may have different adherence problems in HF. It is estimated that those interventions aimed at improving adherence are useful for the reduction of health costs are they are likely more effective than the effects caused by choosing a given drug. The choosing method to assess PTA in practice with reliability is the counting of pills combined with a compliance survey. Time spent to improve adherence not only can improve it but also it can diminish the total time spent by the physician in the follow-up of these patients.

Heart Failure↗

Quality Enhancement Research Initiative for human immunodeficiency virus/acquired immunodeficiency syndrome: framework and plan. HIV-QUERI Executive Committee.

The Veterans Health Administration (VHA) sees approximately equal to 17,000 human immunodeficiency virus (HIV)-infected patients each year, which makes it the largest provider of HIV care in the United States. HIV causes chronic progressive disease that leads to early death. Newer combination antiretro viral treatments are effective but expensive and difficult to use. The HIV Quality Enhancement Research Initiative (HIV-QUERI) uses the QUERI process to identify high-risk and high-volume populations (step 1), which includes those already under VHA care for HIV, those who do not know of their infection, and those at risk for HIV. In identifying best practices (step 2), the HIV-QUERI will benefit greatly from existing guidelines for the care of established HIV infection, but gaps in knowledge regarding adherence to medication regimens and cost-effective screening are large. To identify existing practice patterns (step 3), the HIV-QUERI will develop a clean analytic data set based on Immunology Case Registry files and expand it through a survey of veterans. Interventions to improve care (step 4) will include national, regional, and site-specific feedback on performance relative to quality standards, as well as patient-level and provider-level interventions to improve adherence and support medical decision-making. To document that best practices improve outcomes and quality of life (steps 5 and 6), HIV-QUERI will track indicators on an ongoing basis by use of the Immunology Case Registry database and possible future waves of the survey. In addition, we will require that these issues be addressed in evaluations of HIV-QUERI interventions. In the present article, we present these steps within a framework and plan.

Benchmarking↗

Medication adherence: a key factor in effective management of rosacea.

Rosacea is a chronic condition associated with relapses. Unsuccessful treatment is predicated, in part, on suboptimal adherence with the medication regimen. Motivating long-term compliance remains a challenge. The literature on adherence with rosacea medication is scant, but data from other diseases suggest that a multifactorial approach combining nonpharmacologic and adherence-enhancing pharmacologic interventions appears to offer the greatest success. The variety of topical metronidazole formulations that are relatively well tolerated and convenient to administer has been a notable advance in rosacea management. The dermatologist, by emphasizing the importance of adherence with therapy, can do much to facilitate this most critical behavior.

Algorithms↗

Impact of active drug use on antiretroviral therapy adherence and viral suppression in HIV-infected drug users.

Despite a burgeoning literature on adherence to HIV therapies, few studies have examined the impact of ongoing drug use on adherence and viral suppression, and none of these have utilized electronic monitors to quantify adherence among drug users. We used 262 electronic monitors to measure adherence with all antiretrovirals in 85 HIV-infected current and former drug users, and found that active cocaine use, female gender, not receiving Social Security benefits, not being married, screening positive for depression, and the tendency to use alcohol or drugs to cope with stress were all significantly associated with poor adherence. The strongest predictor of poor adherence and, in turn, failure to maintain viral suppression, was active cocaine use. Overall adherence among active cocaine users was 27%, compared to 68% among subjects who reported no cocaine use during the 6-month study period. Consequently, 13% of active cocaine users maintained viral suppression, compared to 46% of nonusers. Interventions to improve adherence should focus on reducing cocaine use, developing adaptive coping skills, and identifying and treating depression.

Adult↗

An intervention programme using the ASE-model aimed at enhancing adherence in adolescents with asthma.

A randomised controlled trial, involving 112 adolescents with asthma, and a 2-year follow-up was conducted to assess the impact of an intervention programme aimed at enhancing adherence to asthma medication. This programme had a duration of 1 year and consisted of an experimental group which received usual care from a paediatrician, but additionally attended individual and group sessions with an asthma nurse, and a control group which received usual care only. The programme aimed at enhancing adherence by stimulating a positive attitude, increasing feelings of social support, and enhancing self-efficacy. At baseline, and after 12-month (T1) and 24-month (T2) follow-up, the participants filled in questionnaires which were based on the concepts of the ASE-model. Adherence was assessed by self-report (range: 1-10) at the same points in time. After 12 months, 97 adolescents (87%) were available for follow-up, decreasing to 86 adolescents (77%) after 24 months. No statistically significant differences were found between the control and the experimental group, except for one. At T2, self-reported adherence appeared to be statistically significantly higher in the experimental group. In conclusion, there seems to have been no substantial effect of the intervention programme.

Adolescent↗

Attention deficit hyperactivity disorder: a review of the essential facts.

Abstract Attention deficit hyperactivity disorder (ADHD) is a complex disorder, where both genetic and environmental influences make a substantial contribution to the risk for the disorder. One of the challenges facing clinicians is to simplify for parents the multifaceted reasons why their child may have developed ADHD, explain the associated symptoms, and encourage parents to participate in intervention. Increasing parents understanding about ADHD should make them better informed about the disorder, more likely to consent to intervention, and increase adherence to both psychosocial and pharmacological treatment. The aim of this review is to provide clinicians with a brief synopsis of our current understanding about the aetiology of ADHD, co-morbidity and associated problems, developmental course and intervention options.

Attention Deficit Disorder with Hyperactivity↗

Research to improve the quality of care for depression: alternatives to the simple randomized clinical trial.

Recognition of gaps between evidence gained from mental health research and clinical practice in the community together with changes in treatment patterns and patient/provider preferences for care have led to interest in enhancements in the designs and analyses of clinical and community trials of mental health interventions. Gaps between clinical trials and community care include differences in populations and treatment strategies. To bridge these gaps, we propose enhancing the simple randomized trial with several different designs with the immediate aims of improving patient recruitment and adherence in psychiatric intervention studies thus bringing study designs more in line with clinical practice. The goals are to estimate treatment efficacy and effectiveness so that both internal and external validity are optimized. In this discussion, we address design and analytic issues with respect to a number of enhancements of the randomized trial design, including partial patient-provider preference designs, randomized encouragement and consent designs, fixed adaptive design, and random between- and within-patient adaptive designs. Each has advantages and disadvantages depending on the effect under investigation. Some of these enhancements, such as the fixed adaptive design, have begun to be implemented in effectiveness trials in mental health services research, but all are worthy of more attention.

Depression↗

A systematic review of adherence with medications for diabetes.

OBJECTIVE: The purpose of this study was to determine the extent to which patients omit doses of medications prescribed for diabetes. RESEARCH DESIGN AND METHODS: A literature search (1966-2003) was performed to identify reports with quantitative data on adherence with oral hypoglycemic agents (OHAs) and insulin and correlations between adherence rates and glycemic control. Adequate documentation of adherence was found in 15 retrospective studies of OHA prescription refill rates, 5 prospective electronic monitoring OHA studies, and 3 retrospective insulin studies. RESULTS: Retrospective analyses showed that adherence to OHA therapy ranged from 36 to 93% in patients remaining on treatment for 6-24 months. Prospective electronic monitoring studies documented that patients took 67-85% of OHA doses as prescribed. Electronic monitoring identified poor compliers for interventions that improved adherence (61-79%; P < 0.05). Young patients filled prescriptions for one-third of prescribed insulin doses. Insulin adherence among patients with type 2 diabetes was 62-64%. CONCLUSIONS: This review confirms that many patients for whom diabetes medication was prescribed were poor compliers with treatment, including both OHAs and insulin. However, electronic monitoring systems were useful in improving adherence for individual patients. Similar electronic monitoring systems for insulin administration could help healthcare providers determine patients needing additional support.

Diabetes Mellitus↗

Nebulised dornase alpha: adherence in adults with cystic fibrosis.

BACKGROUND: Dornase alpha improves sputum clearance and pulmonary function in patients with moderate bronchiectasis and cystic fibrosis (CF). Several studies have demonstrated variable adherence to treatment regimens in patients with CF. We aimed to compare self-reported adherence with computer based dispensing records of dornase alpha. METHOD: Direct interview of adherence to dornase alpha was compared with pharmacy-dispensing records during a 12-month period. The reasons for dornase alpha usage, and change in lung function in three groups of patients were compared (group 1 (n=42): positive trial, continuing therapy; group 2 (n=13): positive trial, ceased therapy; group 3 (n=22): negative trial). Ninety patients with CF were surveyed. Patients who had ceased dornase alpha provided reasons for drug cessation. Lung function and anthropometric data were collected prior to dornase alpha treatment and at 3 years. Health care professionals rated adherence to therapy. RESULTS: Of the 42 patients on dornase alpha, the average utilisation was 197 days (54%). From dispensing records, 24% of patients were classified as good adherence, 46% as moderate adherence and 30% as poor adherence. Eighty-two percent claimed to use dornase alpha therapy more than 20 days/month, whereas dispensing records showed that only 24% of collected sufficient drug supplies. Health professionals' assessment of adherence of therapy was often incorrect and an overestimation was more common than underestimation. The change in FEV(1) 3 years after trial was not significantly different between groups. There was a negative correlation between initial response to dornase alpha and baseline FEV(1) (r=-0.44, P=0.001), however, initial response was not related to the change in FEV(1) over 3 years (r=0.20, P=0.16). CONCLUSION: There is variability in adherence to dornase alpha in adults with CF and patient self-reporting is likely to over-estimate drug collection from the pharmacy. Further study of the long-term effects of dornase alpha is required. To date, proven interventions to enhance adherence are limited and require investigation in CF.

Administration, Inhalation↗

Hepatitis C treatment eligibility in an urban population with and without HIV coinfection.

In an urban referral clinic, 182 hepatitis C-infected adults including 110 (60%) with HIV coinfection were evaluated for pegylated interferon and ribavirin therapy. Overall, only 33% were eligible for treatment. Considering all patients together, the major barriers to treatment were nonadherence with the evaluation process (23%), refusal of treatment (10%), active substance abuse (9%), and medical contraindication (8%). There was a trend toward a higher rate of treatment eligibility in HIV coinfected patients (39% vs. 25%; p = 0.07), who were significantly more likely to be adherent with the evaluation process compared to those with hepatitis C alone (86% vs. 63%; p = <0.001). Acceptance of antiviral therapy for hepatitis C was similar between eligible persons with and without HIV. These findings highlight the need to develop interventions to improve adherence and to manage substance abuse and other comorbidities in order to maximize the impact of interferon and ribavirin therapy on urban patients with hepatitis C.

Adult↗

Voucher reinforcement improves medication adherence in HIV-positive methadone patients: a randomized trial.

This clinical trial evaluated a contingency management intervention designed to improve medication adherence among HIV-positive methadone maintenance patients. After a 4-week baseline observation phase, eligible participants (N=66) were randomly assigned to: (a) medication coaching sessions every other week to assist with adherence strategies (comparison group) or (b) medication coaching plus voucher reinforcement for opening electronic medication caps on time (voucher group). Baseline adherence (percent doses taken/percent total possible doses) was 51% using electronic measurement, 75% using self-report and 75% using pill count. The intervention was provided for 12 weeks, with a 4-week follow-up. The primary outcome results of the clinical trial indicated effectiveness during the intervention, with significant mean adherence differences between voucher and comparison groups using electronic measurement (78% versus 56%), pill count (86% versus 75%), and self-report (87% versus 69%). Differences between groups faded after vouchers were discontinued. Contingency management shows promise as a strategy to promote antiretroviral medication adherence in this population.

Adult↗

Effects of a tailored lifestyle self-management intervention in patients with type 2 diabetes.

OBJECTIVES: The aim of the present study was to develop, implement and evaluate a brief intervention to improve adherence to the recommended lifestyle changes for patients with Type 2 diabetes, in particular to help patients to reduce the total amount of fat consumed and to increase lifestyle physical activity levels. DESIGN AND METHOD: A brief, tailored lifestyle self-management intervention for patients with Type 2 diabetes was evaluated in a randomized controlled trial. One hundred participants (aged 40 - 70 yrs) completed assessments at three time points- baseline, three months and one year. Participants were allocated to either an intervention group who received the brief tailored intervention including follow-up telephone calls, or a usual care control group. RESULTS: Results indicate that the intervention was successful in helping patients to reduce fat intake and, to a lesser extent, increase lifestyle physical activity levels. These self-reported changes in behaviour were reflected in the objective data with weight maintenance in the intervention group compared to the control group, together with a significant reduction (2 cm) in waist circumference. CONCLUSIONS: These results provide further evidence of the effectiveness of tailored interventions for lifestyle change.

Adult↗

Teleconferenced educational detailing: diabetes education for primary care physicians.

INTRODUCTION: Formal didactic continuing medical education (CME) is relatively ineffective for changing physician behaviour. Diabetes mellitus is an increasingly prevalent disease, and interventions to improve adherence to clinical practice guidelines (CPGs) are needed. METHODS: A stratified, cluster-randomized, controlled trial design was used to evaluate the effects of a teleconferenced educational detailing (TED) CME on glycemic control (hemoglobin [Hb] A1c) and family physician adherence to national diabetes guidelines. TED employed sequential, small-group, case-based education using CPGs delivered by a diabetes specialist. Medical record audit data from baseline through the end of a 12-month postintervention period were compared for the control and intervention groups. Satisfaction with the intervention was evaluated. RESULTS: Sixty-one physicians provided 660 medical records. The intervention did not affect mean Hb A1c levels but did significantly (p = .04) alter the distribution of patients by category of glycemic control, with fewer in the intervention group in inadequate control (15.8% versus 23.9%). More patients took insulin (alone or with oral agents) in the intervention group (21.2% versus 12.0%, p = .03), and more took oral agents only in the control group (89.0% versus 82.9%, p = .005). More patients in the intervention group had documentation of body mass index (7.8% versus 1.9%, p < .02), eye exam (12.1% versus 5.1%, p = .02), and treatment plan (43.5% versus 23.6%, p = .01) and used a flow sheet (14.6% versus 7.7%, p < .03). Although there was general satisfaction with the teleconferencing format, specialist educators found the format more challenging than the family physicians. DISCUSSION: CME delivered by teleconference was feasible, well attended, well received by participants, and improved some key diabetes management practices and outcomes.

Diabetes Mellitus↗

Stages of change for adherence with medication regimens for chronic disease: development and validation of a measure.

BACKGROUND: The stages-of-change (SOC) model has been used to explain and predict how behavior change occurs, but it is new as an approach to understanding why patients fail to take their medications as prescribed. OBJECTIVE: This study validated a 2-item measure of SOC for adherence with medication regimens in 2 groups of patients prescribed pharmacologic therapy for chronic conditions. METHODS: Two cross-sectional studies of attitudes toward medication adherence included the same measure of SOC for medication adherence. One was a sample of 161 HIV-positive patients in the United States, and the other was an international sample of 731 patients with hypertension. The validity of the measure of SOC for medication adherence was examined in both convenience samples using previously validated self-reported measures of adherence (the Medication Adherence Scale and a measure of adherence from the Medical Outcomes Study), and in the HIV sample using electronic monitoring of adherence behavior in 85 patients. RESULTS: Construct validity was demonstrated in both samples by associations between SOC and the previously validated measures of adherence (P < 0.001), and predictive validity was supported by significant associations between SOC for medication adherence and electronically monitored medication-taking behavior during the next 30 days (P < 0.03). CONCLUSIONS: Behavior-change theory suggests that stage-tailored communication strategies are more effective than uniform health-promotion messages. Our results provide a foundation for the development of interventions for medication adherence that are tailored to patients' readiness for change. Our validated 2-item measure of SOC for medication adherence can be used to match communication strategies to individual motivation and readiness for adherence with chronic disease medication regimens.

Anti-HIV Agents↗