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Longitudinal Outcomes of the Face to Face EAP Counseling Services in Greece on Workplace Outcome Suite (WOS): Hellas EAP 2016This presentation shares the research results of employee users of face-to-face counseling provided by Hellas EAP in Greece during the year 2016. Data from 110 cases was compared at before counseling and after a longitudinal follow-up (about 3 months). The five components of the Workplace Outcome Suite (WOS) for EAPs were analyzed for change over time. Significant improvements were obtained on all five outcomes. The greatest degree of change was found for employee presenteeism. These results for the EAP in Greece are comparable with other worldwide benchmark data for the WOS. When the average improvements in employee absenteeism hours and level of work presenteeism were combined, the amount of lost productive time per month per employee was reduced from 8.9 days to 4.4 days. A new analysis method examined the change in the percentage of cases who were at the "Problem Level" on each of the WOS measures. All five measures also showed significant reductions in the number of cases at a problem level from before to after use of the counseling.
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Demonstrating Value: Measuring Outcome & Mitigating Risk: FOH EAP Study Utilizing the Workplace Outcome SuiteDespite the popularity and prevalence of Employee Assistance Programs (EAPs), and the historical emphasis on how EAP can improve work performance, there has been very little rigorous evaluation of the workplace effects of EAP counseling. The aim of this Federal Occupational Health (FOH) outcome study was to examine if and to what degree EAP counseling is associated with improved workplace effectiveness with this particular population. Federal Occupational Health (FOH) is the largest provider of occupational health services in the Federal Government, serving more than 360 federal agencies and reaching 1.8 million federal employees. FOH began providing Employee Assistance Program (EAP) services in 1980 and is Health and Human Services’ recognized expert in this key area of employee health programs, delivering specialized EAP services exclusively to over 905,624 federal employees. In 2004 Selvick, Stephenson, Plaza and Sugden published one of the few studies that demonstrated statistically and practically significant outcomes from the FOH’s EAP. Their work showed significant improvement from pre- to post-EAP intervention on measures of productivity; work and social relationships; perceived health status; attendance and tardiness; and global assessment of functioning. In an effort to revitalize the findings with more current outcomes, FOH engaged an industry gold standard tool, the Workplace Outcome Suite (WOS). This measurement tool consists of a 5-item measure, that has been psychometrically tested and is also easy to administer telephonically. It consists of five scales that measures absenteeism, presenteeism, work engagement, life satisfaction, and workplace distress. In October of 2015 FOH began to collect data on specific outcomes for clients who accessed the EAP. This study reports findings from 2016 and 2017 data that indicates a significant decrease in absenteeism and workplace distress as well as increases in life satisfaction and workplace presenteeism.
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Patient-Reported Outcome and Observer-Reported Outcome Assessment in Rare Disease Clinical Trials: An ISPOR COA Emerging Good Practices Task Force ReportBackground Rare diseases (RDs) affect a small number of people within a population. About 5000 to 8000 distinct RDs have been identified, with an estimated 6% to 8% of people worldwide suffering from an RD. Approximately 75% of RDs affect children. Frequently, these conditions are heterogeneous; many are progressive. Regulatory incentives have increased orphan drug designations and approvals. Objective To develop emerging good practices for RD outcomes research addressing the challenges inherent in identifying, selecting, developing, adapting, and implementing patient-reported outcome (PRO) and observer-reported outcome (ObsRO) assessments for use in RD clinical trials. Good Practices for Outcomes Research This report outlines the challenges and potential solutions in determining clinical outcomes for RD trials. It follows the US Food and Drug Administration Roadmap to Patient-Focused Outcome Measurement in Clinical Trials. The Roadmap consists of three columns: 1) Understanding the Disease or Condition, 2) Conceptualizing Treatment Benefit, and 3) Selecting/Developing the Outcome Measure. Challenges in column 1 include factors such as incomplete natural history data and heterogeneity of disease presentation and patient experience. Solutions include using several information sources, for example, clinical experts and patient advocacy groups, to construct the condition's natural history and understand treatment patterns. Challenges in column 2 include understanding and measuring treatment benefit from the patient's perspective, especially given challenges in defining the context of use such as variations in age or disease severity/progression. Solutions include focusing on common symptoms across patient subgroups, identifying short-term outcomes, and using multiple types of COA instruments to measure the same constructs. Challenges in column 3 center around the small patient population and heterogeneity of the condition or study sample. Few disease-specific instruments for RDs exist. Strategies include adapting existing instruments developed for a similar condition or that contain symptoms of importance to the RD patient population, or using a generic instrument validated for the context of use. Conclusions This report provides state-of-the-art solutions to patient-reported outcome (PRO) and observer-reported outcome (ObsRO) assessments challenges in clinical trials of patients with RDs. These recommended solutions are both pragmatic and creative and posed with clear recognition of the global regulatory context used in RD clinical development programs.
