Development of a New Tool for Evaluating the Benefit of Preventive Treatments for Migraine on Functional Outcomes - The Migraine Functional Impact Questionnaire (MFIQ).

OBJECTIVE: The objective of this study was to develop a method for evaluating patient-relevant outcomes of interventions for preventing migraine attacks, followed by an assessment of the content validity of a new patient-reported outcome (PRO) instrument: the Migraine Functional Impact Questionnaire (MFIQ). BACKGROUND: The aim of preventive treatments for migraine is not only to reduce migraine frequency, but also to restore patients' ability to function and improve quality of life. METHODS: A multi-stage process based on best practice methods and regulatory guidelines for ensuring content validity of PRO instruments for evaluating treatment benefit was followed. Qualitative concept elicitation interviews conducted to understand the experiences of adults with migraine underpinned the development of the instrument. The initial stage included the development of a conceptual disease model (CDM) based on information from these interviews. This CDM was used to identify the concepts of interests (COI) to evaluate outcomes of preventive treatments. The results of the interviews were also used in stage 2, to develop a measurement framework for collecting data about these COI. In the third stage, existing instruments were reviewed for coverage of the concepts in the framework and evidence of concept elicitation to the point of saturation, to support content validity. In the fourth stage, an instrument was drafted to evaluate concepts in the framework, based on the qualitative data collected from the interviews. Following a review by clinical and translation experts, the new instrument was tested in adults with migraine in the fifth stage using 2 rounds of cognitive interviews, and was modified based on interview feedback. In the last stage, the instrument was linguistically adapted, using methods recommended for PRO instruments, to ensure conceptual equivalence of language versions for use in international studies. Each language version was tested in at least 5 native speakers using cognitive interviews. RESULTS: Results from the concept elicitation interviews suggested that migraine had an impact on various aspects of functioning. A conceptual framework for evaluating functional outcomes was developed for the concept selected based on a review of the CDM - physical and emotional functioning, every day activities, and social/leisure activities. Existing PROs lacked coverage of some concepts in the conceptual framework, had recall periods that were inappropriate for capturing the experience of COI or did not have evidence of content validity. A novel PRO instrument, the MFIQ, was developed to address these gaps. Cognitive interviews with 9 adults with migraine resulted in minor changes to the items of the MFIQ, and a final round of 8 interviews confirmed the changes were acceptable and supported its validity. The interviews conducted to test linguistic adaptations confirmed conceptual equivalence in the 25 countries evaluated. CONCLUSIONS: Development of the MFIQ followed best measurement practices to ensure content validity and followed regulatory guidelines for PRO instruments to evaluate benefits of treatments. The MFIQ was developed for use in clinical trials or clinical practice settings to track outcomes of preventive treatments that are most relevant to adults with migraine.

Consumer perceptions about a community pharmacy-based medication take back program.

The stockpiling and improper disposal of unused or expired medications has the potential to harm the environment and humans. Community-based medication take-back programs have been established to ensure proper disposal of unused drugs; however, few of these programs present consumers' perceptions about the program. Therefore, the main aims of this pilot study are 1) to assess the users' and non-users' perceptions about a medication take-back program and 2) to determine if perceptions differ between users and non-users. The results are based on a survey administered to 35 users and 20 non-users of a medication take-back program located at a community pharmacy in Texas. The majority of users were participating in a take-back service for the first time. Though most non-users had never participated in a take-back program, they would consider participating in the future. All users viewed the medication take-back program as a valuable service, while nearly all (90%) non-users viewed the program as a potentially valuable service. The primary reason for participating in the service was to protect the environment. Most respondents (users and non-users) were likely to choose a pharmacy that provides the take-back service more than a pharmacy that does not. More than half of respondents positively viewed paying for the service on a per weight basis. In comparison to non-users, users were significantly older, had more favorable perceptions about paying for the service, and were more likely to choose a pharmacy that provides the service. This pilot study presents overall favorable user perceptions toward medication-take back services and supports the need to establish more community-based take back programs to meet the needs of consumers.

Associations Between Treatment Satisfaction, Medication Beliefs, and Adherence to Disease-Modifying Therapies in Patients with Multiple Sclerosis.

BACKGROUND: Adherence to disease-modifying therapy (DMT) remains problematic for many patients with multiple sclerosis (MS). An improved understanding of factors affecting DMT adherence may inform effective interventions. This study examined associations between treatment satisfaction, medication beliefs, and DMT adherence. METHODS: A survey was mailed in 2016 to 600 adult patients with relapsing-remitting MS taking an injectable or oral DMT. Patients were sampled from the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry. The survey measured self-reported DMT adherence (doses taken divided by doses prescribed during previous 2-week period-adherence ≥0.80), DMT satisfaction using the Treatment Satisfaction Questionnaire for Medication version II, medication beliefs using the Beliefs About Medicines Questionnaire, and demographic and clinical covariates. Relationships between variables were examined using multivariate logistic regression. RESULTS: Final analyses included 489 usable surveys. Mean ± SD participant age was 60.5 ± 8.3 years. Most respondents were white (93.8%), female (86.6%), taking an injectable DMT (66.9%), and adherent to DMT (92.8%). Significant predictors of DMT adherence were age (odds ratio [OR], 1.086; 95% CI, 1.020-1.158; P = .011), type of DMT (oral vs. injectable; OR, 23.350; 95% CI, 2.254-241.892; P = .008), and DMT experience (naive vs. experienced; OR, 2.831; 95% CI, 1.018-7.878; P = .046). CONCLUSIONS: In patients with MS sampled from a patient registry, treatment satisfaction and medication beliefs were not significantly associated with DMT adherence. Based on significant predictors, younger patients, patients taking injectable DMTs, and patients with previous experience with another DMT(s) are at higher risk for nonadherence. Future research is warranted to assess relationships between variables in more diverse MS populations.

Determinants of health-related quality of life in international graduate students.

INTRODUCTION: International graduate students often experience additional levels of stress due to acculturation. Given the impact of stress on health outcomes (both physical and mental), this study examined the health-related quality of life (HRQoL) in international graduate students to determine its association with acculturative stress, perceived stress, and use of coping mechanisms. METHODS: A cross-sectional, self-administered survey was designed and sent to 38 student chapters within the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) student network. HRQoL [physical component summary (PCS) and mental component summary (MCS)] was measured using the 12-item Short Form (SF-12) while coping mechanisms were assessed using the Brief COPE Scale. Acculturative and perceived stress were assessed using the Acculturative Stress Scale for International students [ASSIS] and Graduate Stress Inventory-Revised (GSI-R), respectively. Demographic and personal information (e.g. age, religion) were also collected. Descriptive statistics (mean ± SD and frequency) and hierarchical multiple regression analysis were conducted. RESULTS: The average PCS and MCS were 60 ± 9 and 44 ± 13, respectively, indicating that while the physical health was above the United States (US) general population norm (50), mental health scores were lower. Findings from the hierarchical multiple regression showed that perceived and acculturative stress significantly predicted mental health. Acculturative stress was also a significant predictor of physical health. CONCLUSION: The results from this study support the hypothesis that international students in the US experience both perceived and acculturative stress that significantly impacts their HRQoL. Universities should consider providing education on stress reduction techniques to improve the health of international graduate students.

Predictors of prostate cancer screening using Andersen's Behavioral Model of Health Services Use.

PURPOSE: The purposes of the study were to examine the prevalence of prostate cancer screening (PCS) in the United States and to identify predictors of PCS guided by Andersen's Behavioral Model of Health Services Use (ABM). METHODS: PCS rates were analyzed in men (aged ≥40y) using 2014 data from the Behavioral Risk Factor Surveillance System. Descriptive analysis was conducted using sampling weights to determine the prevalence of PCS (i.e., had a prostate-specific antigen test). Multiple logistic regression within the framework of ABM was used to identify predictors of PCS. The ABM variables of predisposing (e.g., age), enabling (e.g., health insurance), and need (e.g., comorbidities) comprised the independent variables. RESULTS: Among the 131,415 men, 62.4% (N = 82,014) reported that they had a prostate-specific antigen test in the last 2 years. Among predisposing factors, age, education, income, and employment status were significantly associated with undergoing PCS. Informed decision-making process, health care coverage, regular health care provider, and length of time since last routine checkup were significant enabling factors. Health care provider recommendation and previous cancer diagnosis were significant need factors. CONCLUSIONS: Most older men in the United States had previously engaged in PCS. Several ABM variables were predictive of PCS and should be considered when developing future strategies to encourage PCS in at-risk men with the recommended life expectancies. Such strategies should also ensure that the decision to undergo PCS is an informed process between patients and their health care providers.