Healthcare resource use and indirect costs associated with migraine in Italy: results from the My Migraine Voice survey.

AIMS: To evaluate the healthcare resource use (HRU) and cost of lost productivity due to migraine among Italians with ≥4 monthly migraine days (MMDs), with a focus on those with ≥2 prior preventive treatment failures (TFs). MATERIALS AND METHODS: Data from Italian participants from the My Migraine Voice survey were used to assess migraine-related HRU and migraine's impact on work productivity and daily activities using the Work Productivity and Activity Impairment questionnaire. The mean, annualized cost of lost productivity was estimated using the Human Capital Approach and extrapolated to employed Italian population with ≥4 MMDs to calculate the overall migraine-related indirect cost burden in Italy. RESULTS: Data of 420 participants, enrolled between September 2017 and February 2018, were analyzed (mean age: 38.5 years, 81.2% women, 37.8% with ≥2 TF). During a 6-month period, 57.6% of participants visited general practitioners (mean visits: 4.5), 31.9% neurologists (mean visits: 2.6), and 26.4% headache specialists (mean visits: 2.8). Overall, 32.0% of participants had ≥1 emergency room visit (mean visits: 2.8) and 15.0% had ≥1 hospitalization (mean visits: 2.9) because of migraine in the past 12 months. Participants who were employed (N = 215) reported 15.5% absenteeism, 45.3% presenteeism, 53.8% overall work impairment, and 52.6% activity impairment. The mean annualized indirect cost was estimated to be €14,368. The annual indirect cost burden was estimated to be €7.6 billion for the employed Italian population with ≥4 MMDs. The impact of migraine was particularly high among the ≥2 TF subgroups on all parameters. The indirect cost was estimated to be €15,881 (€5,007 attributed to absenteeism). CONCLUSION: Migraine-related HRU and indirect costs are high among individuals with ≥4 MMDs (particularly those with ≥2 TF). There is a need for more effective treatments and better management of migraines to reduce the functional and economic burden among this difficult-to-treat population.

Linguistic validation into 20 languages and content validity of the rheumatoid arthritis-specific Work Productivity and Activity Impairment questionnaire.

BACKGROUND: Impairments in work productivity and daily activities contribute to the burden of rheumatoid arthritis (RA). It is thus essential to use an instrument assessing both work and daily activity impairments when studying the full impact of RA on individuals. The Work Productivity and Activity Impairment (WPAI) questionnaire is such an instrument. OBJECTIVE: This study aims to linguistically validate the RA-specific WPAI (WPAI:RA) instrument in 20 new languages and to assess its content validity for individuals with RA. METHODS: The linguistic validation of the questionnaire followed a standard methodology that included comprehension test interviews (n = 5 individuals with RA per language) to assess the relevance, understanding and acceptability of the WPAI:RA. Content validity of the instrument was simultaneously investigated. RESULTS: Comprehension testing showed that the WPAI:RA questionnaire was well understood similarly across countries; minor changes were made to ensure fidelity to the original concepts and for ease of comprehension. The majority of interviewees (66/93) considered its content comprehensive and appropriate to measure their ability to work and perform daily activities. CONCLUSION: The WPAI:RA questionnaire is now linguistically validated in 20 new languages [Czech (Czech Republic), Dutch (Belgium), English (Canada and UK), French (Belgium, Canada and France), German (Germany), Hungarian (Hungary), Italian (Italy), Polish (Poland), Portuguese (Brazil), Romanian (Romania), Russian (Russia and Ukraine), Spanish (Argentina, Mexico, Spain and US) and Ukrainian (Ukraine)]. The WPAI:RA questionnaire shows good content validity. It can thus be used in multi-country clinical trials to assess RA-related impact on the patients' ability to work and perform daily activities.

Validity, reliability and responsiveness of the Work Productivity and Activity Impairment Questionnaire in ankylosing spondylitis.

OBJECTIVE: To determine the validity, reliability and responsiveness of the Work Productivity and Activity Impairment questionnaire in AS (WPAI:SpA). METHODS: Baseline and Week-24 data from a randomized, double-blind study of adalimumab in patients with AS were used. Discriminative validity of WPAI:SpA absenteeism, presenteeism, overall work productivity loss and activity impairment scores was assessed relative to patient-reported outcomes: Bath AS Disease Activity Index (BASDAI), AS Quality of Life Questionnaire (ASQOL), Short-Form 36 Health Survey (SF-36), Physical and Mental Component Summaries (PCS and MCS, respectively) and Health Utilities Index Mark 3 (HUI-3). Responsiveness of the WPAI:SpA instrument was assessed for patients meeting the minimum clinically important differences (MCIDs) for ASQOL and BASDAI (i.e. quality of life and clinical responders, respectively) and quantified with standardized response mean (SRM) calculations. RESULTS: Of 315 patients, 205 were employed at baseline. Patients with more severe AS (BASDAI > median) showed significantly greater impairment in work and daily activities than patients with lesser disease severity (P < 0.001). This trend was consistent for ASQOL, SF-36 PCS, SF-36 MCS and HUI-3. There were significant differences in WPAI:SpA scores for patients achieving BASDAI clinical response and ASQOL quality of life response vs non-responders. For responders, SRMs were large for work presenteeism, overall work impairment and activity impairment (-0.86 to -1.29 for BASDAI; -0.89 to -1.18 for ASQOL) and small for absenteeism (-0.25 for BASDAI; -0.31 for ASQOL). CONCLUSIONS: The WPAI:SpA is a valid, reliable and responsive tool for assessing work productivity for patients with AS. TRIAL REGISTRATION: ClinicalTrials.gov, http://clinicaltrials.gov/ct2/home, NCT00085644.

Validity, reliability, and responsiveness of the work productivity and activity impairment questionnaire in Crohn's disease.

BACKGROUND: Crohn's disease (CD) is a chronic inflammatory bowel disease usually diagnosed in early adult life and characterized by unpredictable flares and debilitating symptoms such as diarrhea, abdominal pain, and fever, which can interfere with a patient's ability to work and perform daily activities. OBJECTIVE: The aim of this study was to assess the validity, reliability, and responsiveness of the Work Productivity and Activity Impairment questionnaire in CD (WPAI:CD). METHODS: The WPAI:CD was tested in CD patients enrolled in a 26-week randomized clinical trial of cer-tolizumab pegol versus placebo. Discriminative validity of WPAI:CD absenteeism, presenteeism(reduced on-the-job effectiveness), overall work productivity loss (absenteeism + presenteeism), and activity impairment scores was assessed relative to 5 measures of disease severity and health status: CD Activity Index (CDAI), Short Form-36 physical component summary (PCS) and mental health component summary (MCS) scores, Inflammatory Bowel Disease Questionnaire (IBDQ), and the 5-dimensional EuroQoL health-related quality-of-life visual analog scale (EQ-VAS). Responsiveness was assessed by comparing changes in WPAI:CD scores from baseline to week 26 for patients in remission (CDAI <150 points) versus no remission. Standardized Response Means (SRMs) were calculated to evaluate the magnitude of the changes. RESULTS: A total of 662 patients (mean [range] age, 37.4 [18-77] years; male, 288 [43.5%]; white, 629 [95.0%]) were enrolled in the study. Patients with CD of the worst severity (CDAI > median) showed significantly higher impairment in work (+10.5%) and activities (+10.4%) versus patients with "best health" (no problems) (both, P < or = 0.001). Patients with "worst" IBDQ, PCS, MCS, and EQ-VAS scores also showed significantly higher impairments in work (IBDQ, VAS -24.2%; PCS, -24.1%; MCS, -15.9%; EQ-VAS, -16.5%) and activities (IBDQ, -23.3%; PCS, -21.8%; MCS, -16.5%; EQ-VAS, -17.2%) versus "best" scores (all, P < 0.05). There were significant differences between WPAI:CD impairment scores for patients in remission versus patients failing to achieve remission (P < 0.05). SRMs were small (ie, <0.5) in the nonre-mission group, and moderate to large (ie, >0.5) for patients in remission. CONCLUSIONS: The discriminative validity, reliability, and responsiveness of the WPAI:CD were demonstrated. The WPAI:CD may be useful for evaluating drug impact on CD.

Development and testing of a new outcome measure of relationship between patients with Alzheimer's disease and their partners.

In mild Alzheimer's disease (AD), loss of relationship with the patient is a significant consequence for the partner (relative) and may be amenable to improvement with effective intervention. To evaluate relationship dynamics, the authors developed and tested content and discriminative validity of the self-administered Partner-Patient Questionnaire for Shared Activities among 100 partners of patients with mild to moderate Alzheimer's disease. Principal component analysis confirmed that interference in 17 activities derived from the literature and partner-specified activities comprised a relationship factor; internal consistency was very high. Time spent caregiving, caregiver esteem, lack of family support, and impact on partner health and activities were significant predictors of the Partner-Patient Questionnaire for Shared Activities, but the patient's cognitive and mood states were not. The Partner-Patient Questionnaire for Shared Activities warrants additional psychometric testing as a measure of Alzheimer's disease outcome.

Linguistic validation of the US Spanish work productivity and activity impairment questionnaire, general health version.

INTRODUCTION: There are no measures of health-related absenteeism and presenteeism validated for use in the large and increasing US Spanish-speaking population. Before using a Spanish translation of an available English-language questionnaire, the linguistic validity of the Spanish version must be established to ensure its conceptual equivalence to the original and its cultural appropriateness. OBJECTIVE: The objective of this study was to evaluate the linguistic validity of the US Spanish version of the Work Productivity and Activity Impairment questionnaire, General Health Version (WPAI:GH). METHODS: A US Spanish translation of the US English WPAI:GH was created through a reiterative process of creating harmonized forward and back translations by independent translators. Spanish-speaking and English-speaking subjects residing in the US self-administered the WPAI:GH in their primary language and were subsequently debriefed by a bilingual (Spanish-English) interviewer. RESULTS: US Spanish subjects (N = 31) and English subjects (N = 35), stratified equally by educational level, with and without a high school degree participated in the study. The WPAI-GH item comprehension rate was 98.6% for Spanish and 99.6% for English. Response revision rates during debriefing were 1.6% for Spanish and 0.5% for English. Responses to hypothetical scenarios indicated that both language versions adequately differentiate sick time taken for health and non-health reasons and between absenteeism and presenteeism. CONCLUSION: Linguistic validity of the US Spanish translation of the WPAI:GH was established among a diverse US Spanish-speaking population, including those with minimal education.

Validation of electronic data capture of the Irritable Bowel Syndrome--Quality of Life Measure, the Work Productivity and Activity Impairment Questionnaire for Irritable Bowel Syndrome and the EuroQol.

OBJECTIVES: To assess the comparability, reliability, and subject acceptability of electronic data capture (EDC) versions of Irritable Bowel Syndrome-Quality of Life (IBS-QOL), EuroQoL (EQ-5D) and Work Productivity and Activity Impairment (WPAI:IBS) instruments. METHODS: Comparability of EDC and paper questionnaires was evaluated in 72 subjects with IBS who completed a baseline EDC or paper questionnaire, a crossover questionnaire 24 hours later, and a retest of the crossover version at 1 week. The EDC version was presented on a hand-held device. Comparability was assessed using paired t-test statistics, intraclass correlation coefficients (ICC) and tests for internal consistency (Cronbach's alpha). RESULTS: No significant differences were found between scores obtained by paper questionnaire and EDC at the baseline and crossover assessments. ICCs between baseline and crossover assessments ranged from 0.83 to 0.96 for the IBS-QOL scores, 0.82 to 0.96 for the WPAI:IBS scores, and 0.77 to 0.82 for the EQ-5D. Internal consistency was comparable for the two data collection methods for the IBS-QOL overall score (0.96) and subscales and the EQ-5D Index (0.70 vs. 0.74). Retest statistics (ICC) were generally comparable between the EDC and paper versions for all scores. Ease of use was comparable for the two modes of administration, but more patients preferred EDC (47.2%) than the paper questionnaire (23.6%). CONCLUSIONS: EDC versions of the IBS-QOL, EQ-5D, and WPAI:IBS are comparable to paper questionnaires in internal consistency and test-retest reliability, and have greater patient acceptability.

Validation of the Dermatology Life Quality Index and the Work Productivity and Activity Impairment-Chronic Hand Dermatitis questionnaire in chronic hand dermatitis.

In a double-blind, randomized trial of 257 patients with chronic hand dermatitis, the validity, reproducibility, and responsiveness of the Dermatology Life Quality Index and the Work Productivity and Activity Impairment questionnaire were established, and the sample size required to detect meaningful differences between treatment groups was estimated.