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Objective: The Outcome Measures in Rheumatology (OMERACT) Worker Productivity Group continues efforts to assess psychometric properties of measures of presenteeism., Methods: Psychometric properties of single-item and dual answer multiitem scales were assessed, as well as methods to evaluate thresholds of meaning., Results: Test-retest reliability and construct validity of single item global measures was moderate to good. The value of measuring both degree of difficulty and amount of time with difficulty in multiitems questionnaires was confirmed. Thresholds of meaning vary depending on methods and external anchors applied., Conclusion: We have advanced our understanding of the performance of presenteeism measures and have developed approaches to describing thresholds of meaning.

Objective: The Contextual Factors Working Group aims to provide guidance on addressing contextual factors in rheumatology trials within OMERACT., Methods: During the Special Interest Group session at OMERACT 2018, preliminary results were presented from a case scenario survey and semistructured interviews, including contextual factors mentioned in these. A group-based exercise sought to identify and rank important generic contextual factors., Results: A total of 79 candidate factors were listed. Across the 3 groups, gender/sex, comorbidities, and the healthcare system were ranked as most important., Conclusion: The identified important contextual factor domains may be considered a provisional list pending further research.

Objective: The importance of contextual factors (CF) for appropriate patient-specific care is widely acknowledged. However, evidence in clinical trials on how CF influence outcomes remains sparse. The 2014 Outcome Measures in Rheumatology (OMERACT) Handbook introduced the role of CF in outcome assessment and defined them as "potential confounders and/or effect modifiers of outcomes in randomized controlled trials." Subsequently, the CF Methods Group (CFMG) was formed to develop guidance on how to address CF in clinical trials., Methods: First, the CFMG conducted an e-mail survey of OMERACT working groups (WG) to analyze how they had addressed CF in outcome measurement so far. The results facilitated an informed discussion at the OMERACT 2016 CFMG Special Interest Group (SIG) session, with the aim of gaining preliminary consensus regarding an operational definition of CF and to make a first selection of potentially relevant CF., Results: The survey revealed that the WG had mostly used the OMERACT Handbook and/or the International Classification of Functioning, Disability and Health (ICF) definition. However, significant heterogeneity was found in the methods used to identify, refine, and categorize CF candidates. The SIG participants agreed on using the ICF as a framework along with the OMERACT Handbook definition. A list with 28 variables was collected including person-related factors and physical and social environments. Recommendations from the SIG guided the CFMG to formulate 3 preliminary projects on how to identify and analyze CF., Conclusion: New methods are urgently needed to assist researchers to identify and characterize CF that significantly influence the interpretation of results in clinical trials. The CFMG defined first steps to develop further guidance.

Objective: Indicators of work role functioning (being at work, and being productive while at work) are important outcomes for persons with arthritis. As the worker productivity working group at OMERACT (Outcome Measures in Rheumatology), we sought to provide an evidence base for consensus on standardized instruments to measure worker productivity [both absenteeism and at-work productivity (presenteeism) as well as critical contextual factors]., Methods: Literature reviews and primary studies were done and reported to the OMERACT 12 (2014) meeting to build the OMERACT Filter 2.0 evidence for worker productivity outcome measurement instruments. Contextual factor domains that could have an effect on scores on worker productivity instruments were identified by nominal group techniques, and strength of influence was further assessed by literature review., Results: At OMERACT 9 (2008), we identified 6 candidate measures of absenteeism, which received 94% endorsement at the plenary vote. At OMERACT 11 (2012) we received over the required minimum vote of 70% for endorsement of 2 at-work productivity loss measures. During OMERACT 12 (2014), out of 4 measures of at-work productivity loss, 3 (1 global; 2 multiitem) received support as having passed the OMERACT Filter with over 70% of the plenary vote. In addition, 3 contextual factor domains received a 95% vote to explore their validity as core contextual factors: nature of work, work accommodation, and workplace support., Conclusion: Our current recommendations for at-work productivity loss measures are: WALS (Workplace Activity Limitations Scale), WLQ PDmod (Work Limitations Questionnaire with modified physical demands scale), WAI (Work Ability Index), WPS (Arthritis-specific Work Productivity Survey), and WPAI (Work Productivity and Activity Impairment Questionnaire). Our future research focus will shift to confirming core contextual factors to consider in the measurement of worker productivity.

Objective: The Outcome Measures in Rheumatology (OMERACT) international consensus initiative has successfully developed core sets of outcome measures for trials of many rheumatologic conditions, but its expanding scope called for clarification and updating of its underlying conceptual framework and working process. To develop a core set of what we propose to call outcome measurement instruments, consensus must be reached both on what to measure and how to measure. This article deals with the first part: a framework necessary to ensure comprehensiveness of the domains chosen for measurement. We formulated a conceptual framework of core measurement areas in clinical trials, for discussion at the OMERACT 11 conference., Methods: We formulated a framework and definitions of key concepts adapted from the literature, and followed an iterative consensus process (small group processes and an Internet-based survey) of those involved including patients, health professionals, and methodologists within and outside rheumatology., Results: The draft framework comprises 4 core "areas": death, life impact (all aspects of how a patient feels or functions), resource use (monetary and other costs of the health condition and interventions), and pathophysiologic manifestations (disease-specific clinical and psychological signs, biomarkers, and potential surrogate outcome measures necessary to assess specific effects). The survey responses (262 of 2293, response rate 11%) indicated broad agreement with the draft framework and the proposed definitions of key concepts, including understandability and feasibility. A total of 283 comments were processed., Conclusion: In an iterative process, we have developed a generic framework for outcome measurement and working definitions of key concepts ready for discussion at the OMERACT 11 conference.

The objective of the Outcome Measures in Rheumatology (OMERACT) Worker Productivity working group is to identify worker productivity outcome measures that meet the requirements of the OMERACT filter. At the OMERACT 11 Workshop, we focused on the at-work limitations/productivity component of worker productivity (i.e., presenteeism) - an area with diverse conceptualization and instrumentation approaches. Various approaches to quantify at-work limitations/productivity (e.g., single-item global and multi-item measures) were examined, and available evidence pertaining to OMERACT truth, discrimination, and feasibility were presented to conference participants. Four candidate global measures of presenteeism were put forth for a plenary vote to determine whether current evidence meets the OMERACT filter requirements. Presenteeism globals from the Work Productivity and Activity Impairment Questionnaire (72% support) and Rheumatoid Arthritis-specific Work Productivity Survey (71% support) were endorsed by conference participants; however, neither the presenteeism global item from the Health and Work Performance Questionnaire nor the Quantity and Quality method achieved the level of support required for endorsement at the present time. The plenary was also asked whether the central item from the Work Ability Index should also be considered as a candidate measure for potential endorsement in the future. Of participants at the plenary, 70% supported this presenteeism global measure. Progress was also made in other areas through discussions at individual breakout sessions. Topics examined include the merits of various multi-item measures of at-work limitations/productivity, methodological issues related to interpretability of outcome scores, and approaches to appraise and classify contextual factors of worker productivity. Feedback gathered from conference participants will inform the future research agenda of the working group.

At OMERACT 8 in May 2006 in Malta, the International Classification of Functioning, Disability and Health (ICF) was introduced as a universal model and a universal classification to describe human functioning. The potential usefulness of the ICF for the OMERACT process was highlighted and reported in a position paper following the OMERACT 8 meeting. Since then representatives of several OMERACT working groups with an interest in the ICF joined an OMERACT-ICF reference group. Most members had experience with the ICF and worked further to integrate the ICF into OMERACT. We describe the main roles of the ICF in the OMERACT process and the challenges when practice confronts theory.

Worker productivity is a combination of time off work (absenteeism) due to an illness and time at work but with reduced levels of productivity while at work (also known as presenteeism). Both can be gathered with a focus on application as a cost indicator and/or as an outcome state for intervention studies. We review the OMERACT worker productivity groups' progress in evaluating measures of worker productivity for use in arthritis using the OMERACT filter. Attendees at OMERACT 9 strongly endorsed the importance of work as an outcome in arthritis. Consensus was reached (94% endorsement) for fielding a broader array of indicators of absenteeism. Twenty-one measures of at-work productivity loss, ranging from single item indicators to multidimensional scales, were reviewed for measurement properties. No set of at-work productivity measures was endorsed because of variability in the concepts captured, and the need for a better framework for the measurement of worker productivity that also incorporates contextual issues such as job demands and other paid and unpaid life responsibilities. Progress has been made in this area, revealing an ambivalent set of results that directed us back to the need to further define and then contextualize the measurement of worker productivity.