James E. Aikens

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.

The concordance of self-report with other measures of medication adherence: A summary of the literature

Objective:The objective of this study was to evaluate the concordance of self-report measures of medication adherence (interview, diary, or questionnaire) with nonself-report measures of adherence (administrative claims, pill count or canister weight, plasma drug concentration, electronic monitors, or clinical opinion). Methods:A literature search was conducted to identify published reports in which self-report and nonself-report measures of adherence were used within the same study. The concordance of measures within each study was categorized as high, moderate, or low based on a comparison of the adherence estimates. Results:Eight-six comparisons of self-report to nonself-report measures of adherence were identified. Thirty-seven of the 86 comparisons (43%) were categorized as highly concordant. However, concordance varied substantially by type of self-report measure and nonself-report measure. Self-report measures, in general, were highly concordant with electronic measures in only 17% of comparisons, whereas they were highly concordant with other types of nonself-report measures in 58% of comparisons (chi-square = 14.30, P <0.01). When comparing self-report measures, interviews had significantly lower concordance with nonself-report measures as compared with questionnaires or diaries (chi-square = 8.47, P = 0.01). In 15 comparisons of interviews with electronic measures, none of the comparisons were highly concordant, whereas questionnaires and diaries had moderate-to-high concordance with electronic measures in 12 of 16 comparisons (75%). Conclusions:The concordance of self-report and other measures of medication adherence varies widely based on the type of measures used. Questionnaires and diaries tend to have moderate-to-high concordance with other measures of medication adherence. However, interview-based self-reports are not concordant with electronic measures. Questionnaire and diary methods could be preferable to interviews for self-reported medication adherence.

Prevalence of nonadherence with maintenance mesalamine in quiescent ulcerative colitis

OBJECTIVE:There are scant data regarding outpatient adherence in quiescent ulcerative colitis aside from patients enrolled in controlled clinical trials. We conducted a prevalence study to determine the medication adherence rate of maintenance therapy and to identify possible risk factors for nonadherence.METHODS:Outpatients with clinically quiescent ulcerative colitis for >6 months on maintenance mesalamine (Asacol, Procter and Gamble, Cincinnati, OH) were eligible. Patients were interviewed regarding disease history, and demographics were obtained from medical records. Refill information for at least 6 months was obtained from computerized pharmacy records. Adherence was defined as at least 80% consumption of supply dispensed. Using nonadherence as the outcome of interest, stratified analysis and regression modeling were used to identify significant associations.RESULTS:Data were complete for the 94 patients recruited. The overall adherence rate was found to be 40%. The median amount of medication dispensed per patient was 71% (8–130%) of the prescribed regimen. Nonadherent patients were more likely to be male (67%vs 52%, p < 0.05), single (68%vs 53%, p = 0.04), and to have disease limited to the left side of the colon versus pancolitis (83%vs 51%, p < 0.01). Sixty-eight percent of patients who took more than four prescription medications were found to be nonadherent versus only 40% of those patients taking fewer medications (p = 0.05). Age, occupation, a family history of inflammatory bowel disease, length of remission, quality-of-life score, or method of recruitment (telephone interview vs clinical visit) were not associated with nonadherence. Logistic regression identified that a history of more than four prescriptions (odds ratio [OR] 2.5 [1.4–5.7]) and male gender (OR 2.06 [1.17–4.88]) increased the risk of nonadherence. Two statistically significant variables, which were protective against nonadherence, were endoscopy within the past 24 months (OR 0.96 [0.93–0.99]) and being married (OR 0.46 [0.39–0.57]).CONCLUSION:Nonadherence is associated with multiple concomitant medications, male gender, and single status. These patient characteristics may be helpful in targeting those patients at higher risk for nonadherence.

Adherence to Maintenance-Phase Antidepressant Medication as a Function of Patient Beliefs About Medication

PURPOSE This study aimed to identify the demographic, psychiatric, and attitudinal predictors of treatment adherence during the maintenance phase of antidepressant treatment, ie, after symptoms and regimen are stabilized. METHODS We surveyed 81 primary care patients given maintenance antidepressant medications regarding general adherence, recent missed doses, depression and treatment features, medication beliefs (necessity, concerns, harmfulness, and overprescription), and other variables. Additional data were collected from medical and payer records. RESULTS Median treatment duration was 75 weeks. Adherence and beliefs were broadly dispersed and unrelated to treatment duration and type, physical functioning, and demographics. Multivariate analysis adjusting for social desirability, depression severity, and treatment duration indicated that an antidepressant-specific “necessity-minus-concerns” composite was strongly associated with both adherence outcomes. Specifically, adherence was highest when necessity exceeded concerns and lowest when concerns exceeded necessity. We crossed these 2 dimensions to characterize 4 patient attitudes toward antidepressants: skepticism, indifference, ambivalence, and acceptance. CONCLUSIONS Patients given maintenance antidepressants vary widely in adherence. This variation is primarily explained by the balance between their perceptions of need and harmfulness of antidepressant medication, in that adherence is lowest when perceived harm exceeds perceived need, and highest when perceived need exceeds perceived harm. We speculate on ways to tailor adherence strategies to patient beliefs. Subsequent research should determine whether patients’ perceptions about medication predict depression outcomes, can be used to improve clinical management, and respond to behavioral intervention.

The effects of sleep loss and fatigue on resident-physicians: a multi-institutional, mixed-method study.

Purpose. To identify and model the effects of sleep loss and fatigue on resident–physicians’ professional lives and personal well-being. Method. In 2001–02, 149 residents at five U.S. academic health centers and from six specialties (obstetrics–gynecology, emergency medicine, family medicine, internal medicine, pediatrics, surgery) were recruited for the study. Residents were all in good standing in their programs. In a mixed-methods design, focus groups consisted of an average of seven (range, three to 14) individuals in the same year of training and residency program, for a total of 60 interns and 89 senior residents. Trained moderators conducted focus groups using a standardized, semistructured discussion guide. Participants also completed a 30-item quantitative questionnaire assessing sleepiness and workplace sleep attitudes that included the Epworth Sleepiness Scale (ESS). Results. Residents described multiple adverse effects of sleep loss and fatigue on learning and cognition; job performance, including professionalism and task performance; and personal life, including personal well-being and relationships with spouse or significant other and family. Only 16% of the sample scored within the “normal” range on the ESS; 84% scored in the range for which clinical intervention is indicated. Sleepiness was consistent across institution, specialty, years of training, age, gender, marital status, and having children. Conclusions. More residents perceived that sleep loss and fatigue had major impact on their personal lives during residency, leaving many personal and social activities and meaningful personal pleasures deferred or postponed. Sleep loss and fatigue also had major impact on residents’ abilities to perform their work. This finding further substantiates the growing concern about the potential impact on professional development. These observations should be taken into account in developing new training guidelines and educational interventions for housestaff.

The assessment of anxiety and fear in persons with chronic pain : A comparison of instruments

Instruments used to study anxiety and fear responses related to chronic pain vary along two dimensions. They differ in terms of the stimuli or situations that evoke anxiety responses and the types of anxiety responses included (i.e. cognitive, motoric, and physiological). This study examined relations of variables from the Pain Anxiety Symptoms Scale (PASS), the Fear-Avoidance Beliefs Questionnaire (FABQ), the Fear of Pain Questionnaire (FPQ), and the trait version of the Spielberger State-Trait Anxiety Inventory (STAI) with variables related to pain severity, perceived disability, and pain behavior. Subjects were 45 consecutive referrals to a university pain clinic who completed these measures during their evaluation. Results suggested that anxiety responses directly related to the patients particular pain sensations are more relevant to the understanding of chronic pain than are more general tendencies to respond anxiously or fear more varied pain stimuli. Regression analyses showed that empirically selected subsets of the anxiety variables predict from 16 to 54% of the variance in pain severity, disability and pain behavior. Also, assessment of multiple anxiety response types appears useful for understanding pain behavior and disability. Further study of fear and anxiety responses of persons with pain is likely to benefit from careful selection of measures dependent on the stimulus and response dimensions assessed.

Sildenafil in the treatment of erectile dysfunction after radical prostatectomy.

OBJECTIVES To evaluate the efficacy of sildenafil for the treatment of erectile dysfunction after radical prostatectomy and to determine whether age, preservation of the neurovascular bundles (NVBs), or the interval between surgery and the initiation of sildenafil therapy influences the response to sildenafil. METHODS We began this study in April 1998, immediately after the Food and Drug Administration approved sildenafil. We surveyed 170 men who had undergone radical retropubic prostatectomy, had not recovered natural erections sufficient for intercourse, and subsequently received sildenafil between 3 and 24 months postoperatively. The data were collected through a confidential mail survey conducted by a clinical nurse. The men used a dose of 50 mg sildenafil and increased this to 100 mg if they did not obtain an adequate response. RESULTS In the 120 men who began taking sildenafil at least 12 months after surgery, the overall response rate was 29%. Results varied markedly by patient age and number of NVBs preserved. In men younger than 55 years in whom both NVBs had been preserved, the response rate was 80%. In contrast, no patient older than 55 years in whom only one NVB had been preserved reported an adequate response. Regardless of age, no patient in whom both NVBs had been excised reported success with sildenafil. Of the 50 patients who began taking sildenafil less than 9 months after surgery and who had not recovered natural sexual function, none reported erections adequate for intercourse using sildenafil. CONCLUSIONS Sildenafil is an effective treatment for men with erectile dysfunction after radical retropubic prostatectomy, particularly in younger men in whom both NVBs have been preserved. It is ineffective in men in whom both NVBs have been excised, and it is also ineffective in older men in whom only one NVB has been preserved. Sildenafil appears ineffective in the first 9 months after prostatectomy.

A Replicated Prospective Investigation of Life Stress, Coping, and Depressive Symptoms in Multiple Sclerosis

Life stress and coping responses jointly contribute to psychological adjustment in many chronic illness populations, but their significance in multiple sclerosis (MS) has not been extensively investigated. Physical disability, cognitive status, negative life stress, coping strategies, and depressive symptoms were prospectively assessed in 27 adults with definite or probable MS. Of the original subjects, 22 provided two additional assessments at 6-month intervals. After accounting for cognitive status and physical disability, life stress was positively correlated with current as well as future depressive symptoms; the prospective relationship was replicated within the second pair of prospective data waves. Escape avoidance was the only coping strategy that added to the prediction of future mood symptoms, but this was not replicated. Results suggest that MS-related depressive symptoms are a function of prior disease-related impairment, life stress, and possibly escape avoidance coping.

Self-report measures of medication adherence behavior: recommendations on optimal use

Medication adherence plays an important role in optimizing the outcomes of many treatment and preventive regimens in chronic illness. Self-report is the most common method for assessing adherence behavior in research and clinical care, but there are questions about its validity and precision. The NIH Adherence Network assembled a panel of adherence research experts working across various chronic illnesses to review self-report medication adherence measures and research on their validity. Self-report medication adherence measures vary substantially in their question phrasing, recall periods, and response items. Self-reports tend to overestimate adherence behavior compared with other assessment methods and generally have high specificity but low sensitivity. Most evidence indicates that self-report adherence measures show moderate correspondence to other adherence measures and can significantly predict clinical outcomes. The quality of self-report adherence measures may be enhanced through efforts to use validated scales, assess the proper construct, improve estimation, facilitate recall, reduce social desirability bias, and employ technologic delivery. Self-report medication adherence measures can provide actionable information despite their limitations. They are preferred when speed, efficiency, and low-cost measures are required, as is often the case in clinical care.

Prospective Associations Between Emotional Distress and Poor Outcomes in Type 2 Diabetes

OBJECTIVE Cross-sectional studies link both depressive symptoms (DS) and diabetes-related distress (DRD) to diabetes self-management and/or glycemic control. However, longitudinal studies of these variables are rare, and their results are somewhat conflicting. The study objective was to compare DS and DRD as longitudinal predictors of medication adherence, self-care behavior, and glycemic control in type 2 diabetes. RESEARCH DESIGN AND METHODS Primary care patients with type 2 diabetes reported DS, DRD, and other variables at baseline were studied. Medication adherence, self-care behaviors (diet, physical activity, and glucose testing), and glycemic control (HbA1c) were assessed 6 months later (n = 253). Cross-sectional and longitudinal regression analyses were used to model behavioral and medical outcomes as a function of baseline confounders, DS, and DRD. RESULTS Adjusted cross-sectional and longitudinal analyses yielded very similar results. In the latter, only DS were significantly associated with future diet behavior (P = 0.049), physical activity (P = 0.001), and glucose testing (P = 0.018). In contrast, only DRD predicted future glycemic control (P < 0.001) and medication adherence (P = 0.011). CONCLUSIONS Distress-outcome associations seem to vary by type of distress under consideration. Only DS predicts future lifestyle-oriented self-management behaviors. In contrast, only DRD predicts glycemic control, perhaps by decreasing medication adherence. Clinical assessment and intervention should encompass both types of distress, unless the goal is to narrowly target a highly specific outcome.