Peter W. Choo

Validation of patient reports, automated pharmacy records, and pill counts with electronic monitoring of adherence to antihypertensive therapy

OBJECTIVES To evaluate the validity of patient report, pharmacy dispensing records, and pill counts as measures of antihypertensive adherence using electronic monitoring as the validation standard. METHODS The study was conducted among 286 members of Harvard Pilgrim Health Care, a managed care organization, who were at least 18 years of age, on monotherapy for hypertension, and had prescription drug coverage. Prescription refill adherence during the 12 months before enrollment was determined from their automated pharmacy dispensing records. Participants were interviewed about their medication adherence before and after a 3-month electronic monitoring period during which pill counts were also performed. Adherence to both recommended number and timing of doses was estimated from electronic monitoring data. Data analysis was based on statistical correlation and analysis of variance. RESULTS Electronic adherence monitoring revealed that the proportion of prescribed doses consumed was higher (0.92) than the proportion of doses taken on time (0.63). The correlation between adherence to quantity and timing of doses was 0.32. Concurrent pill counts and earlier refilling patterns were moderately correlated with electronic monitoring (pill count: r = .52 with quantity and r = .17 with timing; refill adherence r = .32 with quantity and r = .22 with timing). There was considerable misclassification of adherence reported by patients, although nonadherence was generally accurately reported. CONCLUSIONS Deviation from recommended timing of doses appears to be greater than from prescribed number of doses. Pharmacy dispensing records demonstrate predictive validity as measures of cumulative exposure and gaps in medication supply. Adherence levels determined from pill counts and pharmacy dispensing records correlate more closely with quantity than with timing of doses. Nonadherence reported by patients can serve as a qualitative indicator and predictor of reduced adherence.

Positive emotion and health : Going beyond the negative

This study examined the relationships between positive emotions and health. Two positive emotions were considered, hope and curiosity, in conjunction with 3 physician-diagnosed disease outcomes: hypertension, diabetes mellitus, and respiratory tract infections. Medical data were abstracted over a 2-year period from 1,041 patient records from a multispecialty medical practice, and emotions were assessed through a mailed questionnaire. Across 3 disease outcomes, higher levels of hope were associated with a decreased likelihood of having or developing a disease. Higher levels of curiosity were also associated with decreased likelihood of hypertension and diabetes mellitus. Results suggest that positive emotion may play a protective role in the development of disease.

The impact of acute herpes zoster pain and discomfort on functional status and quality of life in older adults

ObjectivesTo describe the interference of herpes zoster (HZ) pain and discomfort with activities of daily living (ADLs) and health-related quality of life (HRQL) during the acute rash phase, and to quantify the relationship between acute HZ pain and discomfort and impaired ADLs and HRQL in older persons. MethodsProspective, observational study of 160 HZ outpatients age ≥60 at 4 US study sites who completed the Zoster Brief Pain Inventory (ZBPI), Zoster Impact Questionnaire (ZIQ), McGill Pain Questionnaire, EuroQol, and SF-12 questionnaires on a predetermined schedule. Patients rated interference on a 0 to 10 scale for ADL items in the ZBPI and the ZIQ. Interference scores were averaged to create summary measures for the ZBPI items (ZBPI ADLI) and ZIQ items (ZIQ ADLI). A composite pain score was used in mixed-effects models analyses of the association between pain and discomfort and ADLI and HRQL measures during the first 35 days after HZ rash onset. ResultsHZ pain interfered with all ADLs but interference was greatest for enjoyment of life, sleep, general activity, leisure activities, getting out of the house, and shopping. For every 1.0 point increase in pain and discomfort intensity, there was a 0.69 and 0.53 point increase in ZBPI and ZIQ interference, respectively, and a 2.81 point, 1.57 point, and 1.95 point decrease in EuroQol, SF-12 physical, and SF-12 mental scales, respectively. DiscussionAcute zoster pain and discomfort has a significant negative impact on functional status and HRQL in older adults. The magnitude of interference increases with increasing pain and discomfort intensity.

Male sexual dysfunction associated with antiretroviral therapy.

To determine whether treatment with protease inhibitors (PIs) is associated with male sexual dysfunction, we conducted a retrospective, cohort study of 254 adult male PI recipients who received care from the staff-model division of a large managed care organization in New England between 1993 and 1998. After a median of 5.0 years of observation, 80 incident cases of sexual dysfunction were observed. Relative to unexposed individuals, the rate of sexual dysfunction adjusted for confounding was most elevated with use of ritonavir (hazard ratio [HR], 2.83; 95% confidence interval [CI], 1.34-5.97; p =.006) followed by indinavir (HR, 1.69; 95% CI, 0.84-3.37; p =.14), nelfinavir (HR, 1.53; 95% CI, 0.66-3.54; p =.32) and saquinavir (HR, 1.25; 95% CI, 0.53-2.96; p =.60). We conclude that PIs, especially ritonavir, appear to increase the risk of sexual dysfunction.

Terfenadine-associated ventricular arrhythmias and QTc interval prolongation: A retrospective cohort comparison with other antihistamines among members of a health maintenance organization☆

This study compared the occurrence of syncope, ventricular arrhythmias, and corrected QT interval (QTc) prolongation over a 2 1/2-year period in persons prescribed terfenadine versus other prescription antihistamines among 265,000 members of the Harvard Community Health Plan (HCHP), the largest staff-model health maintenance organization in New England. HCHP maintains an automated medical record system with coded diagnoses for each ambulatory and hospital visit, and a similar automated pharmacy system with information for each member on all prescriptions filled at its pharmacies. Among 0.86 million exposure days of terfenadine and 1.04 million exposure days of other antihistamines, we found no excess risk of either clinical/arrhythmia events (odds ratio (OR), 0.86; 95% confidence interval (CI), 0.52 to 1.44) or QTc prolongation (OR, 1.00; 95% CI, 0.64 to 1.57) during courses of terfenadine versus those of other antihistamines. Joint courses of antihistamines and oral erythromycin were associated with an increased risk of QTc prolongation (OR, 2.33; 95% CI, 1.31 to 4.15), and there was a trend for this to be observed more frequently with terfenadine (OR, 2.37; 95% CI, 0.73 to 7.51; P = 0.14).

Community and Patient Values for Preventing Herpes Zoster

ObjectivesThe US Advisory Committee on Immunization Practices has recently recommended a new vaccine against herpes zoster (shingles) for routine use in adults aged ≥60 years. However, estimates of the cost effectiveness of this vaccine vary widely, in part because of gaps in the data on the value of preventing herpes zoster. Our aims were to (i) generate comprehensive information on the value of preventing a range of outcomes of herpes zoster; (ii) compare these values among community members and patients with shingles and post-herpetic neuralgia (PHN); and (iii) identify clinical and demographic characteristics that explain the variation in these values.MethodsCommunity members drawn from a nationally representative survey research panel (n = 527) completed an Internet-based survey using time trade-off and willingness-to-pay questions to value a series of scenarios that described cases of herpes zoster with varying pain intensities (on a scale of 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain) and duration (30 days to 1 year). Patients with shingles (n = 382) or PHN (n = 137) [defined as having symptoms for =90 days] from two large healthcare systems completed telephone interviews with similar questions to the Internet-based survey and also answered questions about their current experience with herpes zoster. We constructed generalized linear mixed models to evaluate the associations between demographic and clinical characteristics, the length and intensity of the health states and time trade-off and willingness-to-pay values.ResultsIn time trade-off questions, community members offered a mean of 89 (95% CI 24, 182) discounted days to avoid the least severe scenario (pain level of 3 for 1 month) and a mean of 162 (95% CI 88, 259) discounted days to avoid the most severe scenario (pain level of 8 for 12 months). Compared with patients with shingles, community members traded more days to avoid low-severity scenarios but similar numbers of days to avoid high-severity scenarios. Compared with patients with PHN, community members traded fewer days to avoid high-severity scenarios. In multivariate analyses, older age was the only characteristic significantly associated with higher time trade-off values.In willingness-to-pay questions, community members offered a mean of

Ibuprofen and skin and soft tissue superinfections in children with varicella

US450 (95% CI 203, 893) to avoid pain of level 3 for 1 month and a mean of

Derivation of adherence metrics from electronic dosing records

US1384 (95% CI 873, 2050) [year 2005 values] to avoid pain of level 8 for 12 months. Community members traded less money than patients with either shingles or PHN to avoid both low- and high-severity scenarios (p-values <0.05 to <0.001). In multivariate models, male gender, higher income and having experienced shingles or PHN were associated with higher willingness to pay to avoid herpes zoster.When patients were asked to assign a value to avoiding their own case of herpes zoster, those with shingles assigned a mean of 67 days or

A cohort study of possible risk factors for over-reporting of antihypertensive adherence

US2319, while those with PHN assigned a mean of 206 days or

Paronychia in association with indinavir treatment.

US18 184. Both the time and monetary value traded were associated with the maximum intensity of the pain the individual had experienced, but neither was associated with the duration of the pain.ConclusionsWe believe that this study provides the most comprehensive information to date on the value individuals place on preventing herpes zoster, and it includes the only such valuation from nationally representative community members as well as patients with herpes zoster. Community members would trade substantial amounts of time or money to avoid herpes zoster, even in the least severe scenarios. The time trade-off results in this study may differ from those in other studies because of important differences in methods of assessing health utilities. Consideration of both community and patient perspectives is crucial to help decision makers fully determine the implications of their policies now that a vaccine against herpes zoster is available.