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Adherence to treatment in children and adolescent patients with cystic fibrosis.

PURPOSE: The purpose of this study was to monitor medication adherence in cystic fibrosis (CF) patients and its correlation with disease severity and patient age. METHODS: Children less than 12 years of age (group 1) and adolescents 12 years of age and older (group 2) were recruited from the University of Michigan CF Center. The study duration was 3 months. A total of 22 patients per group were enrolled. Adherence to ADEKs, an oral multivitamin, and dornase alfa, a nebulized mucolytic medication, was monitored. Adherence to ADEKs was monitored by using the Medication Event Monitoring System (MEMS) SmartCaps (APREX, AARDx, Inc., Union City, California). Dornase alfa adherence rate was monitored by counting empty medication vials. RESULTS: Thirty-three patients completed the study, 15 patients in group 1 and 18 patients in group 2. The overall mean adherence rates for ADEKs and dornase alfa were (+/- SD) 63.6% +/- 24.0% and 66.5% +/- 31.2%, respectively. The median ADEKs and dornase alfa adherence rate for group 1 was 84.6% and 79.1%, respectively (p = .08); and for group 2 was 56.7% vs. 78.4%, respectively (p = .07). There was a trend toward significance, suggesting that the adherence rate for ADEKs was higher than for dornase alfa (p = .08) in group 1. Group 2 showed a trend toward adherence to dornase alfa than to ADEKs (p = .07). There was a trend for ADEKs adherence between groups 1 and 2 (p = .09), but not for dornase alfa (p = .93). CONCLUSION: Parental supervision and disease severity are likely to play a major role in adherence to medical management. Partnership with patients and families about the treatment plan might be important for improving adherence rate. The MEMS SmartCaps is an electronic monitoring technology that should be used to measure drug adherence objectively both in further larger clinical trials and in the outpatient setting.

Administration, Oral↗

Adherence to HIV medications in a cohort of men who have sex with men: impact of September 11th.

Adherence to highly active antiretroviral therapy (HAART) regimens remains a challenge for people living with human immunodeficiency virus (HIV). Severe traumas like that of September 11, 2001, can exacerbate the difficulties already associated with adherence. A community-based sample of 68 HIV-seropositive men who have sex with men (MSM) living in New York City who were on protease inhibitor HAART regimens completed quantitative assessments to examine adherence in the aftermath of September 11th. Data were drawn from a larger study of drug use and HIV medication adherence. Assessments conducted from September 24, 2001 to October 24, 2001 were compared to assessments taken 2-4 months prior to September 11th. Repeated measures analyses of variance were used to analyze the number of missed and suboptimal doses (doses taken outside the prescribed time by +/-4 hours) reported in the 2 weeks prior to each respective assessment. The results indicated a significant increase in the number of missed doses and the number of suboptimal doses immediately after the events of September 11th. Differences in adherence were not influenced, however, by sociodemographic characteristics. These results suggest that the events of September 11th had an impact on adherence to HIV medications among MSM in New York City and provide further support for the notion that the events of September 11th may have adversely impacted the lives of seropositive individuals. Attention should be paid by clinicians working with HIV-positive individuals on how this event has been incorporated into lives of individuals already burdened by a chronic and demanding disease.

Acquired Immunodeficiency Syndrome↗

Brief report: assessing adherence to pediatric antiretroviral regimens using the 24-hour recall interview.

OBJECTIVE: Examine the 24-hr Recall Interview (24RI) for assessing children's antiretroviral medication adherence. METHODS: Caregivers of 54 children with HIV (aged 2-12 years) completed a clinical adherence interview and the 24RI by telephone. Children's viral load and 3-month pharmacy records were obtained. RESULTS: Thirty-seven percent of children missed > or = 1 dose of medicine over 3 days. In 22% of the samples, adherence varied across medications. The 24RI adherence scores (Frequency, Interval, and Dietary Adherence) were moderately reliable across the three interviews. Pharmacy refill rates were significantly related to viral load, and 24RI barriers were marginally significantly related to viral load. CONCLUSIONS: The 24RI, with its systematic, cued recall, and decreased focus on adherence, may reduce socially desirable responding compared to other self-report methods, and reporting adherence barriers may indicate adherence difficulty. However, the validity of the 24RI must be improved to make it a useful measure to include in an adherence assessment battery.

Anti-Retroviral Agents↗

Racial differences in adherence to cardiac medications.

OBJECTIVE: To determine whether there are racial differences in adherence to cardiac medications. DESIGN: Retrospective analysis. PATIENTS: African-American and white male veterans aged 45 years or older who had received any of four groups of drugs: angiotensin-converting enzyme inhibitors (ACEIs), beta-blockers (BBs), calcium channel blockers (CCBs,) or HMG CoA (hydroxymethyl glutaryl coenzyme A) reductase inhibitors (statins). DATA: Administrative records were used to identify eligible veterans and their demographic characteristics, medical diagnoses, and medication use. We used a standard measure of adherence to medications based on whether the veteran obtained enough drug to take it as prescribed on 80% of the days. RESULTS: We identified 833 eligible African-American and 4436 eligible white veterans. In univariable analysis, African Americans were less likely to be adherent to medications than whites for ACEIs (81.4% versus 87.6%, P = 0.004), CCBs (75.3% versus 81.7%, P = 0.003), and statins (59.9% versus 74.1%, P < 0.001) but not BBs (84.8% versus 83.5%, P = 0.6). In multivariable analysis, racial differences in adherence to medications were found primarily among veterans younger than 55 years old. CONCLUSIONS: Younger African Americans were less adherent to medications than whites in a setting where financial barriers are minimized. Although the reason for this finding is unclear, it may contribute to high cardiovascular morbidity among African Americans.

Black or African American↗

Medication management and adherence among cognitively impaired older adults.

This study examined the relationship between patients' cognitive status, deficit awareness, medication management skills, and actual medication adherence. Twenty-seven persons with Alzheimer's disease and 20 healthy controls were evaluated for their predicted and objective performance on tasks related to medication management. Caregivers were also evaluated for their prediction of the care recipient's management abilities. A pill count was taken at the initial interview and 30 days later. MMSE and deficit awareness were related to amount of help received from a family member, suggesting that caregivers tend to accurately assess their relatives' medication management abilities. Adherence rates were acceptable, but some intervention strategies selected by caregivers were not effective in assuring adequate adherence. Additional study is needed to determine the effectiveness of various strategies adopted by informal caregivers.

Aged↗

Measuring adherence to asthma medication regimens.

The failure of patients to adhere to physician-prescribed regimens, either pharmacologic or behavioral, has been well documented in medical literature. Poor adherence to asthma medication regimens has been repeatedly demonstrated in both children and adults, with rates of nonadherence commonly reported from 30 to 70%. Medication regimens for asthma care are particularly vulnerable to adherence problems because of their duration, the use of multiple medications, and the periods of symptom remission. The clinical effects of this nonadherence by asthmatic patients can include treatment failure, unnecessary and dangerous intensification of therapy, and costly diagnostic procedures, complications, and hospitalizations. Although the measurement of adherence is an important component of both medical and behavioral interventions to control asthma, relatively little research has directly addressed the reliability and validity of the measures most widely used to assess asthma medication compliance. This review will discuss methods and issues in the measurement of adherence in general, and where available, measures that have been specifically used in evaluating adherence to asthma medication. Common measures used to assess compliance with asthma medications include direct measures, which confirm the use of medication by assaying it in blood, urine, or saliva, or which confirm the to use a medication, such as observed skill in using a metered dose inhaler. Indirect measures infer use with varying degrees of reliability, by use of clinical judgment, self-report/asthma diaries, medication measurement, and electronic medication monitors. The uses and limitations of these measures will be discussed.

Adult↗

Effect of individual cognitive behaviour intervention on adherence to antiretroviral therapy: prospective randomized trial.

OBJECTIVE: A high level of adherence to antiretroviral therapy is required for complete suppression of HIV replication, immunological and clinical effectiveness. We investigated whether cognitive behaviour therapy can improve medication adherence. DESIGN: Prospective randomized 1-year trial. SETTING: Collaboration of HIV university outpatient clinic and psychotherapists in private practice. PARTICIPANTS: 60 HIV-infected persons on stable antiretroviral combination therapy and viral load below 50 copies/ml. INTERVENTION: Cognitive behaviour intervention in individual patients, in addition to standard of care. MAIN OUTCOME MEASURES: Feasibility and acceptance of intervention; adherence to therapy assessed using medication event monitoring system (MEMS) and self-report questionnaire; virological failure; psychosocial measures. RESULTS: The median number of sessions for cognitive behaviour intervention per patient during the 1-year trial was 11 (range 2-25). At months 10-12, mean adherence to therapy as assessed using MEMS was 92.8% in the intervention and 88.9% in the control group (P=0.2); the proportion of patients with adherence > or = 95% was 70 and 50.0% (P=0.014), respectively. While there was no significant deterioration of adherence during the study in the intervention arm, adherence decreased by 8.7% per year (P=0.006) in the control arm. No differences between the intervention group and standard of care group were found regarding virological outcome. Compared with the control group, participants in the intervention group perceived a significant improvement of their mental health during the study period. CONCLUSIONS: Cognitive behavioural support in addition to standard of care of HIV-infected persons is feasible in routine practice, and can improve medication adherence and mental health.

Adult↗

Correlates of HIV antiretroviral adherence in persons with serious mental illness.

Although several studies have examined the relationship between symptoms of depression or psychological distress and medication adherence, this is the first published study of HIV antiretroviral adherence and its correlates among persons diagnosed with serious mental illness. Forty-five of 47 (96%) participants completed a two-week study in which their adherence to antiretroviral medication was measured using electronic monitoring caps. Mean adherence (proportion of prescribed doses taken) was 66% (SD=34). There were several correlates (p<0.05) of adherence among background and medical characteristics, physical symptoms and side effects, cognitive and psychosocial functioning, and treatment-related attitudes and beliefs. However, in a forward stepwise regression, attendance at recent clinical appointments was the sole predictor that entered the model--accounting for 49% of the variance in adherence. Using attendance at recent clinic appointments as the criterion, adherence readiness (90+% adherence to antiretrovirals) was correctly determined for 72% of the sample. Although not sufficient to serve as the basis for treatment decision making, review of appointment-keeping records may provide clinicians with a simple, cost-effective method for predicting adherence to ongoing treatment, as well as for evaluating adherence readiness to inform the decision of whether to prescribe or defer treatment.

Adult↗

Adherence to calcium/vitamin D and estrogen protocols among diverse older participants enrolled in a clinical trial.

PURPOSE: This study was intended to identify characteristics of those who adhere poorly to calcium/vitamin D and estrogen replacement protocols, and aimed to assess the effects of ethnicity, socio-economic status, and health status on medication adherence. METHODS: The adherence rates of 107 older white, African American and Hispanic participants of a clinical trial involving calcium/vitamin D and either estrogen replacement or placebo therapy were analyzed. Structural equation modeling was used to test the hypothesis that minority participants would have lower adherence rates than white participants, but only if they had lower household incomes and educational achievement, more osteoporosis risk factors, negative health assessments, and fewer somatic complaints than white participants. RESULTS: The average age of participants was 76 years. Minority participants and those with lower SES had lower adherence rates than white participants and those with higher SES. Plausible models that met goodness-of-fit criteria showed that the estrogen/placebo adherence rates were affected directly by being African American or Hispanic and the SF-36 mental health score, and indirectly by somatic complaints. History of fracture and household income directly predicted calcium/vitamin D adherence rates. CONCLUSION: Efforts to improve adherence to medical regimens should consider differences in adherence behaviors based on ethnicity, SES, and mental health.

Aged↗

Correlation between self-reported adherence to highly active antiretroviral therapy (HAART) and virologic outcome.

The Patient Medication Adherence Questionnaire Version 1.0 (PMAQ-V1.0) is a patient-reported adherence instrument to assess medication-taking behaviors and identify barriers to adherence with antiretroviral therapy. To assess the correlation between adherence and virologic outcome, the PMAQ-V1.0 was administered to 194 antiretroviral-experienced adults with HIV infection enrolled in a 16-week evaluation of protease inhibitor-containing regimens featuring a lamivudine/zidovudine combination tablet. At baseline, plasma HIV-1 RNA levels were less than 10,000 copies/mL and CD4(+)-cell counts were equal to or greater than 300 x 10(6)/L; patients had been receiving a conventional regimen of lamivudine + zidovudine (separately) plus a protease inhibitor for at least 10 weeks immediately prior to the study. Forty-eight percent of patients who reported missing at least one dose of a nucleoside reverse-transcriptase inhibitor (NRTI) during the study had detectable plasma HIV-1 RNA, compared with 26% of patients who reported no missed doses (P = .002). Patients who missed at least one dose of an NRTI or protease inhibitor were 2.5 times more likely to have quantifiable HIV-1 RNA than those who reported no missed doses. Patients who reported fewer barriers and more motivators to adherence had better virologic outcomes (P = .001). Several dimensions of the PMAQ-V1.0 did not function as well as hypothesized. In this study, self-reported adherence derived from the PMAQ-V1.0 predicted virologic outcomes, but further refinement of the dimensions appears warranted.

AIDS Serodiagnosis↗

Adherence to physicians' instructions as a factor in managing streptococcal pharyngitis.

Adherence to physicians' instructions, including taking medications as prescribed, is essential for the proper treatment of streptococcal pharyngitis and the prevention of rheumatic fever. Nonadherence can be in many forms, including failure to have prescriptions filled, omission of doses, errors in dosing or administration time, and premature discontinuation of medication. Adherence is dependent on the physician, the patient, the illness, and the medication. Proper communication by the physician and prescribing inexpensive medications that can be taken once or twice daily are simple, yet important actions that improve adherence.

Adolescent↗

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↗

Body image in patients with HIV/AIDS: assessment of a new psychometric measure and its medical correlates.

HIV infection and its treatment can have significant effects on physical appearance and functioning, which can affect self-perceived body image. We assessed the psychometric properties of a newly developed Body Image Scale (BIS), a subjective measure of body image perception in persons with HIV infection, as well as the scale's relationship to disease progression, symptoms, and demographic factors. HIV-positive men (n = 129) and women (n = 21) attending two outpatient HIV clinics were administered the BIS survey along with a one-page questionnaire. A subset (n = 38) were administered the survey on two occasions to assess test-retest reliability. Nearly half of the sample (46%) had AIDS and 25% had a CD4 count below 200 cells/mm(3) within the prior 3 months. The BIS had unidimensional factor structure, good internal consistency reliability (Chronbach alpha = 0.91), and good test-retest reliability (r = 0.71, p < 0.001) after controlling for the length of interval between assessments. Patients' current perception of their body image was worse then what they perceived it to be prior to HIV infection (p < 0.001), but better than their perception of how others view people with HIV (p < 0.001). The presence of symptomatic disease (p < 0.001) and a diagnosis of AIDS (p = 0.02) were associated with a less favorable body image, although laboratory markers of disease progression (CD4 count and plasma HIV viral load) were not. We conclude that the BIS has good construct validity and is a highly reproducible measure of self-perceptive of body image in HIV-infected patients. Further exploration of its relationship to psychological well being, medication adherence and other aspects of medical care is indicated.

Acquired Immunodeficiency Syndrome↗

Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease.

BACKGROUND: The objective of this study was to develop and psychometrically evaluate a general measure of patients' satisfaction with medication, the Treatment Satisfaction Questionnaire for Medication (TSQM). METHODS: The content and format of 55 initial questions were based on a formal conceptual framework, an extensive literature review, and the input from three patient focus groups. Patient interviews were used to select the most relevant questions for further evaluation (n = 31). The psychometric performance of items and resulting TSQM scales were examined using eight diverse patient groups (arthritis, asthma, major depression, type I diabetes, high cholesterol, hypertension, migraine, and psoriasis) recruited from a national longitudinal panel study of chronic illness (n = 567). Participants were then randomized to complete the test items using one of two alternate scaling methods (Visual Analogue vs. Likert-type). RESULTS: A factor analysis (principal component extraction with varimax rotation) of specific items revealed three factors (Eigenvalues > 1.7) explaining 75.6% of the total variance; namely Side effects (4 items, 28.4%, Cronbach's Alpha =.87), Effectiveness (3 items, 24.1%, Cronbach's Alpha =.85), and Convenience (3 items, 23.1%, Cronbach's Alpha =.87). A second factor analysis of more generally worded items yielded a Global Satisfaction scale (3 items, Eigenvalue = 2.3, 79.1%, Cronbach's Alpha =.85). The final four scales possessed good psychometric properties, with the Likert-type scaling method performing better than the VAS approach. Significant differences were found on the TSQM by the route of medication administration (oral, injectable, topical, inhalable), level of illness severity, and length of time on medication. Regression analyses using the TSQM scales accounted for 40-60% of variation in patients' ratings of their likelihood to persist with their current medication. CONCLUSION: The TSQM is a psychometrically sound and valid measure of the major dimensions of patients' satisfaction with medication. Preliminary evidence suggests that the TSQM may also be a good predictor of patients' medication adherence across different types of medication and patient populations.

Adolescent↗

Evaluation of an instructional program for improving medication compliance for chronically mentally ill outpatients.

Outpatient medication adherence is a major problem, especially for patients repeatedly hospitalized for psychiatric disorders. This study included 39 such patients who were receiving case management services from a community mental health center. Patients were matched and randomly assigned to receive in a single session either (1) information regarding medication and its benefits, (2) guidelines for assuring adherence which encompassed all phases related to pill-taking including filling prescriptions, use of a pill container, transportation, self-reminders, doctor's appointments and so forth, or (3) the same guidelines as (2) above but given in the presence of a family member who was enlisted in support. The results showed that adherence increased to about 94% after the guidelines were given for both the individual and family guideline procedure, whereas adherence remained unchanged at 73% after the medication information procedure. These results suggest a practical means for assuring a high level of medication adherence for patients with psychiatric disorders.

Adult↗

The effects of prescription drug copayments on statin adherence.

BACKGROUND: High copayments may present a barrier to medication adherence among patients with chronic conditions such as hyperlipidemia. OBJECTIVE: To assess the effects of statin copayments on statin adherence among individuals with employer-based insurance. STUDY DESIGN: We used a cross-sectional time-series design, with patient as the cross section and month as the time unit. METHODS: Medical and pharmacy claims among continuously enrolled statin users were selected from the 2000-2003 Medstat MarketScan database. Generalized estimating equation models were used to estimate the effects of copayment changes on statin adherence. Adherence was derived from the medication possession ratio, which represents the percentage of days on therapy each month. Separate estimates were obtained for new statin users (n = 142 341) and for continuing statin users (n = 92 344). RESULTS: Higher copayments were associated with lower statin adherence rates. A 100% index copayment increase had a larger effect on monthly adherence (2.6 and 1.1 percentage point decreases in adherence among new users and continuing users, respectively [both P < .01]) than a 100% copayment increase over time (a 1.1 percentage point decrease among new users [P < .01] and a nonsignificant decrease among continuing users). In all models, new statin users were more price sensitive than continuing users. CONCLUSIONS: High copayments are a financial barrier to statin adherence. The index copayment amount can affect compliance with statin use. Given the relationship between statin use and decreased frequency of cardiovascular events and procedures, the implications of high copayments should be considered by policy makers.

Aged↗

Treatment non-adherence in affective disorders.

OBJECTIVE: The aim of this paper is to review the prevalence, predictors and methods for improving medication adherence in unipolar and bipolar affective disorders. METHOD: Studies were identified through Medline and PsycLit searches of English language publications between 1976 and 2001. This was supplemented by a hand search and the inclusion of selected descriptive articles on good clinical practice. RESULTS: Estimates of medication non-adherence for unipolar and bipolar disorders range from 10 to 60% (median 40%). This prevalence has not changed significantly with the introduction of new medications. There is evidence that attitudes and beliefs are at least as important as side-effects in predicting adherence. The limited number of empirical studies of how to reduce non-adherence offer encouraging evidence that, if recognized, the problem can be overcome. CONCLUSION: Only 1-2% of all publications on the treatment of affective disorders explore factors associated with medication non-adherence. This is disappointing as research and clinical data highlight the importance of extended courses of medication in improving the long-term prognosis of affective disorders.

Antidepressive Agents↗

Hierarchical construct validity of the treatment satisfaction questionnaire for medication (TSQM version II) among outpatient pharmacy consumers.

OBJECTIVES: The objectives of this study were twofold: 1) to evaluate the construct validity of the Treatment Satisfaction Questionnaire for Medication (TSQM v. II) using structural equation modeling (SEM); and 2) to assess its concurrent validity using medication adherence criteria. METHODS: Pharmacy patients filling a new medication prescription (n = 342) were recruited from 14 Michigan pharmacies to participate in a 4-week treatment satisfaction study. The TSQM v. II was tested for model fit against an established theoretical model (the Decisional Balance Model of Treatment Satisfaction) using hierarchical confirmatory factor analysis (HCFA). Regression and discriminant analytic models were used to examine the criterion-related validity of the measure. RESULTS: An exploratory factor analysis, used for TSQM v. II item reduction, revealed a strongly dimensional instrument (Effectiveness, Side Effects, and Convenience) and explained 88% of total pooled variance. Results of an HCFA using the final TSQM v. II items suggested a good model fit with the data (P > 0.54). In support of concurrent validity, the TSQM scales explained between 9% and 20% of the variance in dosing adherence and 60% of the variance in the likelihood of future use. Discriminant analysis demonstrated the superior classification power of the hierarchical model of treatment satisfaction over the discrete attribute model when predicting medication discontinuation. CONCLUSIONS: The TSQM v. II has equivalent measurement characteristics as the TSQM v. I, yet uses four fewer items and more consistent wording. The value of the Decisional Balance Model for estimation of dosing adherence and medication persistence over time is discussed.

Aged↗