Work Productivity Activity Impairment Questionnaire Research Articles

Dosing, Patient Satisfaction and Other Patient-Reported Outcomes after Switching to Rurioctocog Alfa Pegol in Athn 2: A Longitudinal, Observational Study of Previously Treated Hemophilia Patients Switching Coagulation Replacement Factor Products

Dosing, Patient Satisfaction and Other Patient-Reported Outcomes after Switching to Rurioctocog Alfa Pegol in Athn 2: A Longitudinal, Observational Study of Previously Treated Hemophilia Patients Switching Coagulation Replacement Factor Products

The impact of rheumatoid arthritis on work and predictors of overall work impairment from three therapeutic scenarios

Aim: To examine the effects of three treatment scenarios in rheumatoid arthritis (RA) on work and to determine potential predictors of work impairment. Materials & methods: Moderate RA patients received etanercept 50 mg weekly plus methotrexate (E50/MTX) for 36 weeks. Those with Disease Activity Score 28 ≤3.2 at week 36 and ≤3.2 from weeks 12–36 were randomized to E50/MTX, etanercept 25 mg weekly/MTX or placebo/MTX for 52 weeks. Results: Work-related components of the Work Productivity Activity Impairment questionnaire significantly improved with E50/MTX, which were maintained at week 88. Age, overall work impairment, disease duration, Health Assessment Questionnaire-Disability Index score >0.5, and pain visual analog scale were significantly predictive of overall work impairment. Conclusion: E50/MTX maintained significant improvements in Work Productivity Activity Impairment:RA. Prediction of potential work impairment may help improve RA work-related issues.

Patient-Reported Outcomes as Primary End Points in Clinical Trials of Inflammatory Bowel Disease

The Food and Drug Administration (FDA) is moving from the Crohn's Disease Activity Index to patient-reported outcomes (PROs) and objective measures of disease, such as findings from endoscopy. PROs will become an important aspect of assessing activity of inflammatory bowel disease (IBD) and for labeling specific drugs for this disease. PROs always have been considered in the management of patients with rheumatoid arthritis or multiple sclerosis, and have included measurements of quality of life, disability, or fatigue. Several disease-specific scales have been developed to assess these PROs and commonly are used in clinical trials. Outcomes reported by patients in clinical trials of IBD initially focused on quality of life, measured by the Short-Form 36 questionnaire or disease-specific scales such as the Inflammatory Bowel Disease Questionnaire or its shorter version. Recently considered factors include fatigue, depression and anxiety, and work productivity, as measured by the Functional Assessment Chronic Illness Therapy-Fatigue, the Hospital Anxiety Depression, and the Work Productivity Activity Impairment Questionnaire, respectively. However, few data are available on how treatment affects these factors in patients with IBD. Although disability generally is recognized in patients with IBD, it is not measured. The international IBD disability index currently is being validated. None of the PROs currently used in IBD were developed according to FDA guidance for PRO development. PROs will be a major primary end point of future trials. FDA guidance is needed to develop additional PROs for IBD that can be incorporated into trials, to better compare patients' experience with different therapies.

AB1392 Predictors of work impairment in a randomized controlled trial of etanercept-methotrexate therapy in patients with moderate rheumatoid arthritis

BackgroundIn patients (pts) with rheumatoid arthritis (RA), work disability is a major consequence of reduced physical function, which can occur with active joint inflammation and joint damage.1,2 In a recent...

SAT0476 Impact of etanercept-methotrexate therapy on patient-reported outcomes in a randomized controlled trial in moderately active rheumatoid arthritis patients

BackgroundNormalization of physical function and health-related quality of life (HR-QoL) is an important treatment goal in patients with rheumatoid arthritis (RA), including those with moderately active disease despite MTX use....