Development and exploration of the content validity of a patient-reported outcome measure to evaluate the impact of migraine- the migraine physical function impact diary (MPFID).

BACKGROUND: Adults with migraine experience substantial reductions in quality of life during and in-between migraine attacks. Clinical and regulatory guidelines encourage the inclusion of patient reported outcomes for the evaluation of benefits of interventions for migraine. METHODS: The conceptual framework and items for a new patient-reported outcome (PRO) instrument, the Migraine Physical Function Impact Diary (MPFID), were developed using scientific methods recommended to ensure content validity of PRO instruments. The MPFID was developed to measure the impact of migraine on physical functioning based on themes raised in concept elicitation (CE) interviews (conducted previously) with adults with migraine. Cognitive interviews were conducted with adults with migraine to further explore content validity. The instrument was modified following an interim analysis of a first round of cognitive interviews, to assess comprehensiveness and clarity of items, instructions, and response options. Refinements were subsequently tested in additional cognitive interviews. RESULTS: The conceptual framework included impacts on physical functioning experienced by most adults with migraine and deemed clinically relevant for measuring the outcome of an intervention for migraine. Concepts in the framework included the impact of migraine on physical impairments (acts) and ability to complete day-to-day activities and perform everyday activities (tasks). MPFID items were generated to evaluate functioning over the past 24 h and to collect data daily, to capture experiences on days with migraine as well as the days in-between migraines. Items asked about needing to rest or lie down; ability to get out of bed, stand up, bend over, walk, perform household chores, do tasks outside the home, keep routines or schedules, get ready for the day, do activities that require concentration or clear thinking; difficulty moving head and body, doing activities requiring physical effort; avoiding interacting with others. Initial modifications based on the first round of cognitive interviews (n = 8) included clarifying instructions, updating three items to enhance specificity and clarity, and revising one item to include gender-neutral language. The second round of interviews (n = 9) confirmed acceptability of revisions and supported content validity. CONCLUSIONS: The results provide qualitative evidence supporting the content validity of the MPFID for evaluating outcomes of interventions for migraine.

Adherence to oral diabetes medications among users and nonusers of antipsychotic medication.

OBJECTIVE: This study compared adherence to oral diabetes medications among users and nonusers of oral antipsychotic medications. Adherence to oral antidiabetics and antipsychotics among antipsychotic users was also compared. METHODS: Texas Medicaid prescription claims data from July 1, 2008, to December 31, 2011, were used to examine adherence to oral antidiabetics among users and nonusers of antipsychotics for 12 months after the first prescription for oral diabetes medication. Users and nonusers of antipsychotics were matched on the basis of their chronic disease score (CDS). Medication adherence was measured by proportion of days covered (PDC), and patients with a PDC value ≥.80 were considered to be adherent. Bivariate and multivariate analyses were used to compare adherence between cohorts. RESULTS: A total of 1,821 patients from each group were matched. The mean PDC for oral antidiabetics was significantly higher among antipsychotic users (.63) than nonusers (.55) (p<.001). About 37% (N=678) of antipsychotic users and 24% (N=473) of nonusers were adherent to oral antidiabetics. After adjustment for age, gender, CDS, and number of prescriptions, antipsychotic users were 2.10 times more likely than nonusers to be adherent to oral antidiabetics (p<.001). Antipsychotic users had higher mean PDC values for antipsychotic medications than for oral antidiabetics (.78±.25 versus .63±.29, p<.001). CONCLUSIONS: Adherence to oral antidiabetics in the Texas Medicaid population was better among antipsychotic medication users than nonusers, but overall adherence was poor for both groups. Low adherence rates highlight the need for interventions to help improve medication management.

Identifying patient characteristics associated with high schizophrenia-related direct medical costs in community-dwelling patients.

BACKGROUND: Schizophrenia is a chronic, debilitating disease that affects approximately 1% of the U.S. population and has disproportionately high costs. Several factors, including age, gender, insurance status, and comorbid conditions, have been hypothesized to be associated with schizophrenia-related costs.  OBJECTIVE: To identify demographic and clinical characteristics of community-dwelling schizophrenia patients experiencing high schizophrenia-related direct medical costs.  METHODS: Community-dwelling patients with a diagnosis for schizophrenic disorder (ICD-9-CM code 295) and other nonorganic psychoses (ICD-9-CM code 298) were identified from the 2005-2008 Medical Expenditure Panel Survey (MEPS). Schizophrenia-related direct medical costs were calculated for (a) inpatient hospitalizations; (b) prescription medications; and (c) outpatient, office-based physician, emergency room, and home health care visits. Using Andersen's Behavorial Model of Health Services Use and the literature, factors that could potentially affect schizophrenia-related direct medical costs were identified. Based on the distribution of their mean annual costs, patients were classified into high- and low-cost groups. Logistic regression was used to determine the likelihood of high-cost group membership based on age, sex, race, insurance status, marital status, region of residence, family income as a percentage of poverty line, number of medical comorbidities, number of mental health-related comorbidities, patient-perceived general health status, patient-perceived mental health status, and year of inclusion in MEPS. In addition, a generalized linear model (GLM) regression (gamma distribution with a log-link function) was used to evaluate the relationships between the independent variables and total schizophrenia-related direct medical costs as a continuous variable.  RESULTS: From the MEPS database, we identified 317 patients with schizophrenia who represented 2.75 million noninstitutionalized, community-dwelling schizophrenia patients in the United States between 2005 and 2008. The logistic regression procedure showed that older patients (OR=0.933, 95% CI=0.902-0.966) and patients with a spouse (OR=0.150, 95% CI=0.041-0.555) were less likely to be in the high-cost group, while those who reported having "poor" perceived general health status (OR=15.548, 95% CI=1.278-189.127) were more likely to be in the high-cost group. The GLM regression procedure showed that younger patients (compared with older patients), African Americans (compared with Caucasions), patients with private insurance (compared with the uninsured), and those living in the northeastern United States (compared with those living in the southern United States) had higher schizophrenia-related direct medical costs.  CONCLUSION: Identification of factors associated with a high-cost population may help decision makers in managed care, government, and other organizations allocate resources more efficiently and health care providers manage patients more effectively through assignment of these patients to case managers and appropriate monitoring and treatment. 

Assessing the quality of pharmacoeconomic studies in India: a systematic review.

OBJECTIVE: The aim of the study was to evaluate the quality of pharmacoeconomic studies based in India. METHODS: A literature search was conducted using PubMed, MEDLINE, EconLit, PsycInfo and Google Scholar to identify published work on pharmacoeconomics studies based in India. Articles were included if they were original studies that evaluated pharmaceuticals, were based in India and were conducted between 1990 and 2010. Two reviewers independently reviewed the articles using a subjective 10-point quality scale in addition to the 100-point Quality of Health Economic Studies (QHES) questionnaire. RESULTS: Twenty-nine articles published between 1998 and May 2010 were included in the review. The included articles were published in 23 different journals. Each article was written by an average of five authors. The mean subjective quality score of the 29 articles was 7.8 (standard deviation [SD] = 1.3) and the mean QHES scores for the complete pharmacoeconomic studies (n = 24) was 86 (SD = 6). The majority of authors resided in India (62%) at the time of publication and had a medical background (90%). The quality score was significantly (p ≤ 0.05) related to the country of residence of the primary author (non-India = higher) and the study design (randomized controlled trials = higher). CONCLUSION: Although the overall quality scores were comparable to (e.g. Nigeria) or higher than (e.g. Zimbabwe) similar studies in other developing countries, key features such as an explicit study perspective and the use of sensitivity analyses were missing in about 40% of the articles. The need for economic evaluation of pharmaceuticals is imperative, especially in developing countries such as India as this helps decision makers allocate scarce resources in a justifiable manner.