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Screening for cognitive impairment (CI) in systemic lupus erythematosus (SLE) relies on the American College of Rheumatology (ACR) neuropsychological battery (NB). By studying the concurrent criterion validity, our goal was to assess the Montreal Cognitive Assessment (MoCA) as a screening tool for CI compared to the ACR-NB and to evaluate the added value of the MoCA to the Automated Neuropsychological Assessment Metrics (ANAM).A total of 285 adult SLE patients were administered the ACR-NB, MoCA, and ANAM. For the ACR-NB, patients were classified as having CI if there was a Z score of ≤-1.5 in ≥2 domains. The area under the curve (AUC) and sensitivities/specificities were determined. A discriminant function analysis was applied to assess the ability of the MoCA to differentiate between CI, undetermined CI, and non-CI patients.CI was not accurately identified by the MoCA compared to the ACR-NB (AUC of 0.66). Sensitivity and specificity were poor at 50% and 69%, respectively, for the cutoff of 26, and 80% and 45%, respectively, for the cutoff of 28. The MoCA had a low ability to identify CI status. The addition of the MoCA to the ANAM led to improvement on the AUC by only 2.5%.The MoCA does not have adequate concurrent criterion validity to accurately identify CI in patients with SLE. The low specificity of the MoCA may lead to overdiagnosis and concern among patients. Adding the MoCA to the ANAM does not substantially improve the accuracy of the ANAM. These results do not support using the MoCA as a screening tool for CI in patients with SLE.

Objectives Cognitive dysfunction (CD) is a common manifestation of SLE that can have detrimental consequences for those affected. To date, no treatments have been approved for SLE-CD. This study aims to assess the association of azathioprine (AZA) and mycophenolate (MMF) use with SLE-CD, given that these medications have demonstrated neuroprotective qualities in prior studies. Methods Consecutive adult SLE patients presenting to a single healthcare center were considered for participation. The ACR neuropsychological battery for SLE was administered to consenting patients at 0, 6 and 12 months. Scores were compared with age- and sex-matched controls. Primary outcome was CD, defined as a z-score ≤−1.5 in two or more cognitive domains. Mixed-effects logistic regression models were constructed to estimate the odds of CD with respect to AZA and MMF use. Results A total of 300 participants representing 676 patient visits completed the study; 114 (38%) met criteria for CD at baseline. The cumulative AZA dose (g/kg) was associated with reduced odds of CD [odds ratio (OR) 0.76 (95% CI 0.58, 0.98), P = 0.04]. Years of AZA treatment was also associated with reduced odds of CD [OR 0.72 (95% CI 0.54, 0.97), P = 0.03]. MMF use was not associated with CD. Conclusion AZA use was associated with significantly lower odds of SLE-CD, while MMF use was not. Additional studies are warranted to further investigate the relationship of AZA and SLE-CD.

Objective The objectives of this study were to: 1) identify predictors of subsequent surgery following initial treatment of proximal humerus fractures (PHF); and 2) generate valid risk prediction tools to predict subsequent surgery. Methods We identified PHF patients ≥ 50 years from 2004 to 2015 using health datasets in Ontario, Canada. We used procedural codes to classify patients into treatment groups of: 1) surgical fixation; 2) shoulder replacement; and 3) conservative. We used procedural and diagnosis codes to capture subsequent surgery within two years post fracture. We developed regression models for two thirds of each group to identify predictors of subsequent surgery, and the regression equations to develop risk tools to predict subsequent surgery. We used the final third of each cohort to evaluate the discriminative ability of the risk tools using c-statistics. Results We identified 20,897 PHF patients, 2,414 treated with fixation, 1,065 with replacement, and 17,418 treated conservatively. Predictors of reoperation following fixation included bone grafting, and nail or wire fixation vs. plate fixation, while poor bone quality was associated with reoperation following initial replacement. In conservatively treated patients, more comorbidities were associated with subsequent surgery, while age 70+, and discharge home following presentation lowered the odds of subsequent surgery. The risk tools were able to discriminate with c-statistics of 0.75-0.88 (derivation) and 0.51-0.79 (validation). Conclusion Our risk tools showed good to strong discriminative ability for patients treated with fixation and conservatively. These data may be used as the foundation to develop a clinically informative tool. Level of evidence Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Objective The Outcome Measures in Rheumatology (OMERACT) is a research organization focused on improving health care outcomes for patients with autoimmune and musculoskeletal diseases. The Connective Tissue Disease-Interstitial Lung Disease (CTD-ILD) Working Group on Lung Physiology is a group within OMERACT charged with identifying outcome measures that should be implemented in studies of patients with CTD-ILD. The OMERACT Filter 2.1 is an evidence-based algorithm used to identify outcome measures that are truthful, feasible, and able to discriminate between groups of interest. Our objective was to summate evidence (published literature, key opinion leader input, patient perspectives) that would influence the CTD-ILD Working Group's vote to accept or reject the use of two measures of lung physiology, the forced vital capacity (FVC) and the diffusion capacity of carbon monoxide (DLco) for use in randomized controlled trials (RTCs) and longitudinal observational studies (LOSs) involving patients with systemic sclerosis associated ILD (SSc-ILD). Methods Patient Research Partners (those afflicted with SSc-ILD) and the CTD-ILD Working Group on Lung Physiology were polled to assess their opinion on the FVC and DLco in terms of feasibility; the CTD-ILD Working Group was also queried on these instruments’ face and content validity. We then conducted a systematic literature review to identify articles in the SSc-ILD population that assessed the following measurement properties of FVC and DLco: (1) construct validity, (2) test-retest reliability, (3) longitudinal construct validity, (4) clinical trial discrimination/sensitivity to detect change in clinical trials, and (5) thresholds of meaning. Results were summarized in a Summary of Measurement Properties (SOMP) table for each instrument. OMERACT CTD-ILD Working Group members discussed and voted on the strength of evidence supporting these two instruments and voted to endorse, provisionally endorse, or not endorse either instrument. Results Forty Patient Research Partners reported these two measures are feasible (are not an unnecessary burden or represent an infeasible longitudinal assessment of their disease). A majority of the 18 CTD-ILD Working Group members voted that both the FVC and DLco are feasible and have face and content validity. The systematic literature review returned 1,447 non-duplicated articles, of which 177 met eligibility for full text review. Forty-eight studies (13 RCTs, 35 LOSs) were included in the qualitative analysis. The FVC SOMP table revealed high quality, consistent data with evidence of good performance for all five measurement properties, suggesting requisite published evidence to proceed with endorsement. The DLco SOMP table showed a lack of data to support test-retest reliability and inadequate evidence to support clinical trial discrimination. There was unanimous agreement (15 [100%]) among voting CTD-ILD Working Group members to endorse the FVC as an instrument for lung physiology in RCTs and LOSs in SSc-ILD. Based on currently available evidence, DLco did not meet the OMERACT criteria and is not recommended for use in RCTs to represent lung physiology of SSc-ILD. The OMERACT Technical Advisory Group agreed with these decisions. Conclusion The OMERACT Filter 2.1 was successfully applied to the domain of lung physiology in patients with SSc-ILD. The FVC was endorsed for use in RCTs and LOSs based on the Working Group's vote; DLco was not endorsed.

Objective To develop an equity extension of the OMERACT Summary of Measurement Properties (SOMP) Table, SOMP Equity to describe whether a patient reported outcome measure (PROM) works well among patients of diverse languages and cultures, education levels, and other population characteristics. Methods We used the PROGRESS-Plus framework to categorize equity characteristics assessed in trials of PROM. PROGRESS refers to Place of residence, Race/ethnicity/culture/language, Occupation, Gender/sex, Religion, Education, Socioeconomic status, and Social Capital, while the ‘plus’ captures additional characteristics, such as age. We pilot tested our SOMP Equity Extension using the Health Assessment Questionnaire (HAQ) as a prototypical PROM. Results The SOMP Equity Extension retains the same columns as the original OMERACT SOMP (domain match, feasibility, construct validity, test-retest reliability, longitudinal construct validity, clinical trial discrimination, thresholds of meaning) but uses the PROGRESS-Plus characteristics as rows. We found several examples of studies of the HAQ which had assessed one or more PROGRESS-Plus characteristics. Conclusions The most commonly reported equity considerations were related to language. OMERACT Equity virtual meeting participants were polled and they indicated that the SOMP Equity Extension is useful for highlighting and tracking equity considerations for OMERACT Core Outcome Measurement Instruments.

INTRODUCTION: OMERACT uses an evidence-based framework known as the 'OMERACT Filter Instrument Selection Algorithm' (OFISA) to guide decisions in the assessment of outcome measurement instruments for inclusion in a core outcome set for interventional and observational clinical trials.METHODS: A group of OMERACT imaging and patient-centered outcome methodologists worked with imaging outcome groups to facilitate the selection of imaging outcome measurement instruments using the OFISA approach. The lessons learned from this work influenced the evolution to Filter 2.2 and necessitated changes to OMERACT's documentation and processes.RESULTS: OMERACT has revised documentation and processes to incorporate the evolution of instrument selection to Filter 2.2. These revisions include creation of a template for detailed definitions of the target domain which is a necessary first step for instrument selection, modifications to the Summary of Measurement Properties (SOMP) table to account for sources of variability, and development of standardized reporting tables for each measurement property.CONCLUSIONS: OMERACT Filter 2.2 represents additional modifications of the OMERACT guide for working groups in their rigorous assessment of measurement properties of instruments of various types, including imaging outcome measurement instruments. Enhanced reporting aims to increase the transparency of the evidence base leading to judgements for the endorsement of instruments in core outcome sets.

The OMERACT Technical Advisory Group recognises that working groups during the process of creating a core outcome set may identify an outcome domain that would be best represented as a composite that encapsulates these component outcome domains by bringing them together into a single outcome. A multi-outcome domain (MOD) is a within-patient combination of component outcomes, and an individual patient's evaluation depends on the observation of all of the components in that patient with a single overall rating determined according to a specified rule; which is often applicable when we consider a disease activity score. A composite outcome domain (COD) consists of a number of component outcomes and is defined as the occurrence in a patient of one, some or all of these specified components; which is often applicable when we consider the risk of adverse events or remission criteria. We review the general benefits, challenges, reporting and interpretation of using MODs and CODs. The development of the MOD or COD instrument for an OMERACT core outcome measurement set is considered through four distinct steps: choosing relevant outcome domains; finding high quality instruments for each of these outcome domains; weighting the outcome domain instruments in the MOD/COD instrument; and putting MOD/COD instrument through the OMERACT Filter. Guidance and training are in preparation for working groups who will be completing the OMERACT Instrument Selection Algorithm (OFISA). As for other initiatives in OMERACT, we will seek feedback from OMERACT working groups who complete the development of their MOD/COD, which will then be incorporated into the refinement of the guidance and training.

Background The evaluation of Patient Reported Outcomes Measurement Information System (PROMIS) computerized adaptive test (CAT) in adults with systemic lupus erythematous (SLE) is an emerging field of research. We aimed to examine the test–retest reliability and construct validity of the PROMIS CAT in a Canadian cohort of patients with SLE. Methods Two hundred twenty-seven patients completed 14 domains of PROMIS CAT and seven legacy instruments during their clinical visits. Test–retest reliability of PROMIS was evaluated 7–10 days from baseline using intraclass correlation coefficient (ICC (2; 1)). The construct validity of the PROMIS CAT domains was evaluated against the commonly used legacy instruments, and also in comparison to disease activity and disease damage using Spearman correlations. A multitrait-multimethod matrix (MMM) approach was used to further assess construct validity comparing selected 10 domains of PROMIS and SF-36 domains. Results Moderate to excellent reliability was found for all domains (ICC [2;1] ranging from lowest, 0.66 for Sleep Disturbance and highest, 0.93 for the Mobility domain). Comparing seven legacy instruments with 14 domains of PROMIS CAT, moderate to strong correlations (0.51–0.91) were identified. The average time to complete all PROMIS CAT domains was 11.7 min. The MMM further established construct validity by showing moderate to strong correlations (0.55–0.87) between select PROMIS and SF-36 domains; the average correlations from similar traits (convergent validity) were significantly greater than the average correlations from different traits. Conclusions These results provide evidence on the reliability and validity of PROMIS CAT in SLE in a Canadian cohort.

Objectives Imaging is one of the most rapidly evolving fields in medicine. Unfortunately, many imaging technologies have been applied as measurement instruments without rigorous evaluation of the evidence supporting their truth, discriminatory capability and feasibility for that context of use. The Outcome Measures in Rheumatology (OMERACT) Filter 2.1 Instrument Selection Algorithm (OFISA) is used to evaluate such evidence for use of an instrument in a research setting. The objectives of this work are to: [1] define and describe the key conceptual aspects that are essential for the evaluation of imaging as an outcome measurement instrument and [2] describe how these aspects can be assessed through OFISA. Methods Experts in imaging and/or methodology met to formalize concepts and define key steps. These concepts were discussed with a team of patient research partners with interest in imaging to refine technical and methodological aspects into comprehensible information. A workshop was held at OMERACT2020 and feedback was incorporated into existing OMERACT process for domain and instrument selection. Results Three key lessons were identified: (1) a clear definition of the domain we want to measure is a necessary prerequisite to the selection of a good instrument, (2) the sources of variability that can directly influence the instrument should be clearly identified, (3) incorporating these first two lessons into OFISA improves the quality of every instrument selection process. Conclusions The incorporation of these lessons in the updated OMERACT Filter (now 2.2) will improve the quality of the selection process for all types of outcome measurement instruments.

Objective To review: 1) degree of conformity to the American College of Rheumatology neuropsychological battery (ACR-NB) among studies that used a NB, 2) review definitions of cognitive impairment (CI) from studies that used a NB, and 3) characterize measurement tools used to assess CI in systemic lupus erythematosus (SLE). Methods The literature search was conducted in Ovid Medline, Embase, and PsycINFO for articles on CI in adult SLE patients. We reviewed studies that used a NB and compared their tests to the ACR-NB to assess the degree of conformity. Definitions of CI from studies that used a NB were reviewed when sufficient information was available. We reviewed and categorized CI measurement tools into four broad categories: NB, screening, incomplete/mixed batteries, and computerized batteries. Results Of 8727 references, 118 were selected for detailed review and 97 were included in the final analysis. Of 43 studies that used a NB, none of the studies used the ACR-NB exactly as published. Many studies supplemented with other tests. Overall, there was inconsistent use of ACR-NB tests. Definitions for CI varied, with cut-offs ranging from 1 to 3 standard deviations below normative values on domains/tests varying in type and number. The most frequently used measurement tool for assessing CI in SLE was a NB. Use of screening tests and computerized batteries have also increased over the last decade. Conclusion The assessment and definition of CI in SLE remains heterogeneous. A consensus meeting to address existing inconsistencies should be considered to harmonize the field of CI in SLE.

Physical activity (PA) participation provides functional and social benefits for persons with mild cognitive impairment (MCI) and Alzheimer’s disease (AD), but PA participation in these populations is low. To support health promotion initiatives for cognitively impaired older adults, this study explored the perceptions, experiences, and beliefs of older adults with cognitive impairment and their caregivers concerning PA. Ten care dyads (community-dwelling adult aged ≥65 years diagnosed with MCI or mild-to-moderate AD and their care partner) participated in semi-structured interviews informed by the Theoretical Domains Framework about their PA perceptions, experiences, and beliefs. Interpretive phenomenological analysis of interview transcripts yielded 4 emergent themes: (1) PA as a meaningful activity, (2) experience versus evidence as motivating, (3) participation is possible despite dementia, and (4) care partners as enablers. Findings from this study address a research gap concerning the PA perceptions, experiences, and beliefs of cognitively impaired older adults and their care partners. Novelty Older adults with MCI/AD want to and are capable of engaging in PA. Care partners are critical supporters of PA participation in MCI/AD. Adapted health promotion strategies could enhance PA in MCI/AD.

Study objective Common outcomes of care valued by emergency department (ED) patients who are not hospitalized have been characterized, but no measurement instrument has been developed to date. We developed and validated a patient-reported outcome measure for use with adult ED patients who are discharged home (PROM-ED). Methods In previous research, 4 main outcomes of importance to ED patients were defined: symptom relief, understanding, reassurance, and having a plan. We developed a bank of potential questions (phase 1) that were first tested for suitability through cognitive debriefing with patients (phase 2). Revised questions were then tested quantitatively with a large panel of participants who had recently received ED care (phase 3). Informed by these results, a panel of experts used a modified Delphi process to make decisions on item reduction. The resulting instrument (PROM-ED 1.0) was then evaluated for its measurement properties (structural validity, hypothesis testing, and reliability). Results Sixty-seven questions divided among 4 scales (1 for each outcome domain) were assembled. In accordance with cognitive debriefing with 8 patients (phase 2), 15 questions were modified and 13 removed. Testing of these questions with 444 participants (phase 3) identified problematic floor or ceiling effects (n=10), excessive correlations between items (n=11), and low item-total correlations (n=7). The expert panel (22 participants, phase 4) made decisions using this information on the exclusion of items, resulting in 22 questions across 4 scales that together constitute the PROM-ED 1.0. Testing provided good evidence of validity and test-retest reliability (n=200). Conclusion The PROM-ED enables the measurement of patient-centered outcomes of importance to patients receiving care in the ED who are not hospitalized. These data could have important applications in research and care improvement.

Purpose Sensibility refers to a tool’s comprehensiveness, understandability, relevance, feasibility, and length. It is used in the early development phase to begin assessing a new tool or intervention. This study examined the sensibility of the job demands and accommodation planning tool (JDAPT). The JDAPT identifies job demands related to physical, cognitive, interpersonal, and working conditions to better target strategies for workplace supports and accommodations aimed at assisting individuals with chronic health conditions. Methods Workers with a chronic health condition and workplace representatives were recruited from health charities, workplaces, and newsletters using convenience sampling. Cognitive interviews assessed the JDAPT’s sensibility. A 70% endorsement rate was the minimum level of acceptability for sensibility concepts. A short screening tool also was administered, and answers compared to the complete JDAPT. Results Participants were 46 workers and 23 organizational representatives (n = 69). Endorsements highly exceeded the 70% cut-off for understandability, relevance, and length. Congruence between screening questions and the complete JDAPT suggested both workers and organizational representatives overlooked job demands when completing the screener. Participants provided additional examples and three new items to improve comprehensiveness. The JDAPT was rated highly relevant and useful, although not always easy to complete for someone with an episodic condition. Conclusions This study highlights the need for tools that facilitate accommodations for workers with episodic disabilities and provides early evidence for the sensibility of the JDAPT.

Objective: Physical function is one of the Outcome Measures in Rheumatology (OMERACT) core outcome domains for hand osteoarthritis studies. Our aim was to select appropriate instrument(s) to measure this domain, as part of the development of a core outcome measurement set.Methods: Following the OMERACT Filter 2.1 instrument selection process, the (function subscale of) the Australian/Canadian Hand Osteoarthritis Index (AUSCAN), Functional Index for Hand Osteoarthritis (FIHOA) and Michigan Hand Outcomes Questionnaire (MHQ) were assessed for domain match, feasibility, truth and discrimination. Data gathered from available literature, working group and patient surveys, and additional analyses in two hand osteoarthritis cohorts were used to inform a consensus process.Results were summarized in Summary of Measurements Properties tables and reviewed by the OMERACT technical advisory group. Results: MHQ passed the assessment of domain match and feasibility by the working group and patient research partners. For AUSCAN important limitations in feasibility were noted, but domain match was good. FIHOA did not pass the assessment and was not taken through the follow-up assessment. Based on published literature, reliability and construct/longitudinal validity of both MHQ and AUSCAN fulfilled OMERACT standards. While clinical trial discrimination and thresholds of meaning were good for AUSCAN, results for MHQ were ambiguous.Conclusion: MHQ was provisionally endorsed as OMERACT core outcome measure for the core domain physical function. While AUSCAN may have better metric properties than MHQ, it received provisional endorsement as a second measure of function due to important feasibility issues. A research agenda to merit full endorsement was set. (c) 2021 The Author(s). Published by Elsevier Inc.

Mortality rates in our fracture liaison service ranged from 2.7% at year 1 to 14.8% at year 5 post-screening. Presentation with multiple simultaneous fractures at screening was associated with higher risk of death. This finding indicates the need for increased focus on this high-risk group. To examine all-cause mortality rates in a provincial fracture liaison service (FLS) and the association between the index fracture type, particularly multiple simultaneous fractures, and the risk of death at follow-up. This cohort study includes fragility fracture patients aged 50+, enrolled in a provincial FLS in Ontario, Canada, between 2007 and 2010. All-cause mortality was assessed using administrative data. Multivariable Cox proportional hazards model was used to examine the risk of death 5 years after screening. Crude mortality rates for 6543 fragility fracture patients were 2.7% at year 1, 5.6% at year 2, and 14.8% at year 5 after screening. After adjusting for age and sex, and relative to distal radius fracture, patients with multiple (simultaneous) fractures at screening had a higher risk of dying (HR = 1.8, 95%CI 1.3–2.4), followed by those with a hip fracture (HR = 1.5, 95%CI 1.3–1.8), a proximal humerus fracture (HR = 1.4, 95%CI 1.2–1.7), and other single fractures (HR = 1.4, 95%CI 1.1–1.7). Having an index ankle fracture was not associated with the risk of death over a distal radius fracture. As compared to the 50–65 age group, patients 66 years and older had a higher risk of death (for 66–70 age group: HR = 2.5, 95%CI 1.9–3.3; for 71–80: HR = 4.3, 95%CI 3.5–5.4; and for 81+: HR = 10.6, 95%CI 8.7–13.0). Females had a lower risk of death (HR = 0.5, 95%CI 0.5–0.6) than males. Presenting with multiple fractures was an indicator of higher risk of death relative to a distal radius fracture. This finding indicates the need for increased focus on this high-risk group.

Objective.The OMERACT-Adherence meeting was convened to discuss the conceptual and methodological challenges in developing a core domain set (Adherence-CDS) for trials of interventions for medication adherence in rheumatology.Methods.Forty participants from nine countries participated.Results.Four ideas emerged: for adherence trials, the Adherence-CDS could include adherence and the condition-specific CDS; many factors affect adherence and are intervention targets, contextual factors, or outcome domains; adherence is a critical factor in drug trials; and standardized adherence measures are needed.Conclusion.Despite the challenges, the meeting clarified an approach to developing an Adherence-CDS that complements existing OMERACT work and methodology.

Objective.The Psoriatic Arthritis (PsA) Core Domain Set for randomized controlled trials and longitudinal observational studies has recently been updated. The joint counts are central to the measurement of the peripheral arthritis component of the musculoskeletal (MSK) disease activity domain. We report the Outcome Measures in Rheumatology (OMERACT) 2018 meeting’s approaches to seek endorsement of the 66/68 swollen and tender joint count (SJC66/TJC68) for inclusion in the PsA Core Outcome Measurement Set (COS).Methods.Using the OMERACT Filter 2.1 Instrument Selection Process, the SJC66/TJC68 was assessed for (1) domain match, (2) feasibility, (3) numerical sense (construct validity), and (4) discrimination (test retest reliability, longitudinal construct validity, sensitivity in clinical trials, and thresholds of meaning). A protocol was designed to assess the measurement properties of the SJC66/TJC68 joint count. The results were summarized in a Summary of Measurement Properties table developed by OMERACT. OMERACT members discussed and voted on whether the strength of the evidence supported that the SJC66/TJC68 had passed the OMERACT Filter as an outcome measurement instrument for the PsA COS.Results.OMERACT delegates endorsed the use of the SJC66/TJC68 for the measurement of the peripheral arthritis component of the MSK disease activity domain. Among patient research partners, 100% voted for a “green” endorsement, whereas among the group of other stakeholders, 88% voted for a “green” endorsement.Conclusion.The SJC66/TJC68 is the first fully endorsed outcome measurement instrument using the OMERACT Filter 2.1 and the first instrument fully endorsed within the PsA COS.

Background. Little is known about the financial management occupations of people living with brain injury, despite the importance of these to adult autonomy. Purpose. This work aims to develop a conceptual framework for financial management after adulthood acquired brain injury. Method. This qualitative study used grounded theory methods. Data included semistructured interviews of 10 adults living with brain injury and two close others who assist with financial management occupations. Analysis included initial and focused coding, memo writing, constant comparison, theoretical sampling of questions, and member checking. Findings. The Financial Management Activity Process conceptual framework describes a complex action process. This includes accounting for factors influencing financial choices and actions, and identifying and using a trusted personalized process, including using financial management strategies aligned with the constraints of factors. Implications. This conceptual framework may be useful to assessment and intervention development. It highlights the between-person and between-activity variability in financial management processes and strategy use.

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.

Introduction: Although calcium pyrophosphate deposition (CPPD) is common, there are no published outcome domains or validated measurement instruments for CPPD studies. In this paper, we describe the framework for development of the Outcome Measures in Rheumatology (OMERACT) CPPD Core Domain Sets. Methods: The OMERACT CPPD working group performed a scoping literature review and qualitative interview study. Generated outcomes were presented at the 2020 OMERACT CPPD virtual Special Interest Group (SIG) meeting with discussion focused on whether different core domain sets should be developed for different calcium pyrophosphate deposition (CPPD) clinical presentations and how the future CPPD Core Domain Set may overlap with already established osteoarthritis (OA) domains. These discussions informed development of a future work plan for development of the OMERACT CPPD Core Domain Sets. Findings: Domains identified from a scoping review of 112 studies and a qualitative interview study of 36 people (28 patients with CPPD, 7 health care professionals, one stakeholder) were mapped to core areas of OMERACT Filter 2.1. The majority of SIG participants agreed there was need to develop separate core domain sets for "short term" and "long term" studies of CPPD. Although CPPD + OA is common and core domain sets for OA have been established, participants agreed that existing OA core domain sets should not influence the development of OMERACT core domain sets for CPPD. Prioritization exercises (using Delphi methodology) will consider 40 potential domains for short term studies of CPPD and 47 potential domains for long term studies of CPPD. Conclusion: Separate OMERACT CPPD Core Domain Sets will be developed for "short term" studies for an individ-ual flare of acute CPP crystal arthritis and for "long term" studies that may include participants with any clinical presentation of CPPD (acute CPP crystal arthritis, chronic CPP crystal inflammatory arthritis, and/or CPPD + OA). (c) 2021 Elsevier Inc. All rights reserved.

Objectives: To develop an operational definition of contextual factors (CF) [1].Methods: Based on previously conducted interviews, we presented three CF types in a Delphi survey; Effect Modifying-, Outcome Influencing -and Measurement Affecting CFs. Subsequently, a virtual Special Interest Group (SIG) session was held for in depth discussion of Effect Modifying CFs.Results: Of 161 Delphi participants, 129 (80%) completed both rounds. After two rounds, we reached consen-sus (>70% agreeing) for all but two statements. The 45 SIG participants were broadly supportive.Conclusion: Through consensus we developed an operational definition of CFs, which was well received by OMERACT members. (c) 2021 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)

Purpose Upper extremity traumatic amputation due to work injury is a devastating injury with poor outcomes. As it does not appear to follow existing theories of psychosocial adjustment to injuries and illness, we sought to understand this problem by asking those who have sustained the injury, how they try to adjust. Methods Qualitative methods were used to interview 11 participants within 3 years of their accident. Questions included “Tell me about the impact of the amputation on your life”. Data were systematically gathered and analyzed using a grounded theory (constructivist) approach which led to a preliminary model of adjustment. Results The Value of the Hand, and the Value of Working and Doing, emerged as central phenomena and created a Value Filter through which our participants’ new experiences were interpreted. Two interacting themes, Instability of the Core Identity, and Efforts to Stabilize the Self, describe the effects of the process which either interfered with or promoted the formation of new values that, in turn, could lead to adjustment. Conclusions The preliminary model helps explain psychosocial adjustment for individuals with a traumatic upper extremity amputation due to work injury. The model may also be useful with other acquired injuries where the lost body part was deemed highly valuable for the individual’s sense of self.

BackgroundClinical studies with work participation (WP) as an outcome domain pose particular methodological challenges that hamper interpretation, comparison between studies and meta-analyses.ObjectivesTo develop Points to Consider (PtC) for design, analysis and reporting of studies of patients with inflammatory arthritis that include WP as a primary or secondary outcome domain.MethodsThe EULAR Standardised Operating Procedures were followed. A multidisciplinary taskforce with 22 experts including patients with rheumatic diseases, from 10 EULAR countries and Canada, identified methodologic areas of concern. Two systematic literature reviews (SLR) appraised the methodology across these areas. In parallel, two surveys among professional societies and experts outside the taskforce sought for additional methodological areas or existing conducting/reporting recommendations. The taskforce formulated the PtC after presentation of the SLRs and survey results, and discussion. Consensus was obtained through informal voting, with levels of agreement obtained anonymously.ResultsTwo overarching principles and nine PtC were formulated. The taskforce recommends to align the work-related study objective to the design, duration, and outcome domains/measurement instruments of the study (PtC: 1–3); to identify contextual factors upfront and account for them in analyses (PtC: 4); to account for interdependence of different work outcome domains and for changes in work status over time (PtC: 5–7); to present results as means as well as proportions of patients reaching predefined meaningful categories (PtC: 8) and to explicitly report volumes of productivity loss when costs are an outcome (PtC:9).ConclusionAdherence to these EULAR PtC will improve the methodological quality of studies evaluating WP.

Objectives To examine i) the relationship between neuropsychological performance and depression and anxiety over time, and ii) the overlap between classification of cognitive dysfunction, anxiety, and depression in SLE. Methods 301 patients with SLE were included. Cognition was measured using a modified version of the ACR neuropsychological battery; cognitive dysfunction was defined as z-scores ≤-1.5 on ≥2 domains. Depression and anxiety were measured using the Beck Depression Inventory-II and the Beck Anxiety Inventory, respectively. All measures were assessed at baseline, 6, and 12 months. Their relationships were analyzed using Multiple Factor Analysis (MFA). Results Anxiety and depression and neuropsychological performance were stable across time. Factor analysis identified two dimensions explaining 42.2% of the variance in neuropsychological performance. The first dimension (33.1% of the variance) included primarily complex cognitive tests measuring executive function; verbal, visual, and working memory; and complex processing speed. The second dimension (9.1% of the variance) included primarily measures of simple information processing speed or motor dexterity. Anxiety and depression scores were consistently related to the first cognitive dimension. There was substantial overlap in participants classified with cognitive dysfunction and anxiety and depression. Conclusions Depression and anxiety symptoms in SLE patients are related to a cognitive dimension incorporating memory, executive function and complex processing speed in a stable manner across one year. Many patients with cognitive dysfunction exhibit clinically significant anxiety and depression. Further research should examine whether cognition improves when anxiety and depression are treated and mechanistic links between anxiety and depression and cognitive dysfunction in SLE.

Chapter 1 provides an overview of the five core domains for the appropriate assessment of patients with systemic lupus erythematosus (SLE) for research and clinical settings: disease activity, chronic damage resulting from lupus activity or its treatment, health-related quality of life (HRQoL), adverse events, and economic impact. Emerging concepts in SLE such as frailty are also introduced along with deep insights on selected existing concepts, in particular cognition, depression, and anxiety as well as fatigue. Having explored what needs to be measured in SLE, this chapter then outlines the decision-making process by which candidate instruments are identified and determined to be a match for the target construct (e.g., disease activity).

ObjectivesThe Outcome Measures in Rheumatology Initiative established the Contextual Factors Working Group to guide the understanding, identification and handling of contextual factors for clinical trials. In clinical research, different uses of the term ‘contextual factors’ exist. This study explores the perspectives of researchers (including clinicians) and patients in defining 'contextual factor’ and its related terminology, identifying such factors and accounting for them in trials across rheumatology.MethodsWe conducted individual semistructured interviews with researchers (including clinicians) who have experience within the field of contextual factors in clinical trials or other potentially relevant areas, and small focus group interviews with patients with rheumatic conditions. We transcribed the interviews and applied qualitative content analysis.ResultsWe interviewed 12 researchers and 7 patients. Researcher's and patient's descriptions of contextual factors were categorised into two broad themes, each comprising two contextual factors types. The ‘treatment effect’ theme focused on factors explaining variations in treatment effects (A) among patients and (B) among studies. The ‘outcome measurement’ theme focused on factors that explain (C) variations in the measurement result itself (apart from actual changes/differences in the outcome) and (D) variations in the outcome itself (beside treatment of interest). Methods for identifying and handling contextual factors differed among these themes and types.ConclusionsTwo main themes for contextual factors with four types of contextual factors were identified based on input from researchers and patients. This will guide operationalisation of contextual factors. Further research should refine our findings and establish consensus among relevant stakeholders.

RÉSUMÉLes plans de retraite des adultes atteints de maladies chroniques sont peu connus. Dans le cadre de cette étude, des travailleurs canadiens âgés de 50 à 67 ans provenant d’un regroupement national de 80 000 personnes (arthrite, n = 631 ; diabète, n = 286 ; arthrite et diabète, n = 111 ; aucune maladie chronique invalidante, n = 538) ont participé à une enquête transversale sur ce sujet. Les questions posées aux participants traitaient de l’âge prévu pour leur départ à la retraite, de leurs plans de travail futurs, de la possibilité d’un départ hâtif à la retraite et de la transition vers la retraite. Des analyses de khi-carré, de variance et des régressions ont permis d’évaluer les attentes et les facteurs qui y étaient associés. Les travailleurs souffrant d’arthrite et de diabète avaient des plans de retraite semblables à ceux des participants sains, malgré leurs problèmes de santé, et ces plans concordaient avec les attentes associées au fait de travailler jusqu’à un âge de retraite conventionnel. Toutefois, le nombre de répondants souffrant d’arthrite ou de diabète qui avaient prévu une retraite anticipée était plus élevé que celui des participants en bonne santé. Contrairement aux prévisions, la part de la variance associée aux facteurs liés à la santé était moindre que celle des autres facteurs en ce qui concerne les attentes en matière de retraite. Ces résultats mettent en lumière la complexité des attentes liées à la retraite et soulignent l’importance de l’adéquation personne-travail, malgré la présence de maladies.

Objective.The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 framework was developed in 2014 to aid core outcome set development by describing the full universe of “measurable aspects of health conditions” from which core domains can be selected. This paper provides elaborations and updated concepts (OMERACT Filter 2.1).Methods.At OMERACT 2018, we discussed challenges in the framework application caused by unclear or ambiguous wording and terms and incompletely developed concepts.Results.The updated OMERACT Filter 2.1 framework makes benefits and harms explicit, clarifies concepts, and improves naming of various terms.Conclusion.We expect that the Filter 2.1 framework will improve the process of core set development.

Objective.To describe the Outcome Measures in Rheumatology (OMERACT) stepwise approach to select and develop an imaging instrument with musculoskeletal ultrasound (US) as an example.Methods.The OMERACT US Working Group (WG) developed a 4-step process to select instruments based on imaging. Step 1 applies the OMERACT Framework Instrument Selection Algorithm (OFISA) to existing US outcome measurement instruments for a specific indication. This step requires a literature review focused on the truth, discrimination, and feasibility aspects of the instrument for the target pathology. When the evidence is completely unsatisfactory, Step 2 is a consensus process to define the US characteristics of the target pathology including one or more so-called “elementary lesions”. Step 3 applies the agreed definitions to the image, evaluates their reliability, develops a severity grading of the lesion(s) at a given anatomical site, and evaluates the effect of the acquisition technique on feasibility and lesion(s) detection. Step 4 applies and assesses the definition(s) and scoring system(s) in cross-sectional studies and multicenter trials. The imaging instrument is now ready to pass a final OFISA check.Results.With this process in place, the US WG now has 18 subgroups developing US instruments in 10 different diseases. Half of them have passed Step 3, and the groups for enthesitis (spondyloarthritis, psoriatic arthritis), synovitis, and tenosynovitis (rheumatoid arthritis) have finished Step 4.Conclusion.The US WG approach to select and develop outcome measurement instruments based on imaging has been repeatedly and successfully applied in US, but is generic for imaging and fits with OMERACT Filter 2.1.

Physicians can struggle in managing return to work (RTW) consultations and facilitating a patient’s return to employment after the injury. As part of an exploration into the role of physicians in R...

Objective.To identify and address patient-reported barriers in osteoporosis care after a fracture.Methods.A longitudinal cohort of fragility fracture patients over 50 years of age was seen in a provincewide fracture liaison service. Followup interviews were done at 6 months for osteoporosis care indicators. Univariate statistics were used to describe baseline characteristics, osteoporosis-related outcomes, and reasons cited for not achieving them. Two phases of this program were compared (Phase I: education and communication, and Phase II: risk assessment education and communication). Phase II was further divided into those who fully participated and those who declined.Results.Phase I (n = 3997) had lower testing and treatment rates than Phase II (n = 1363). Rates were highest in those confirmed as having participated in Phase II (n = 569). Phase II nonparticipants (n = 794) had results as in Phase I. In Phase I, the main patient-reported barriers for not visiting their physician or not having a bone mineral density (BMD) test were patient- and physician-oriented (e.g., being instructed by their physician to not have the BMD test). In Phase II, BMD testing was part of the program, thus the main barriers were around treatment choices. Phase II eligible nonparticipants experienced many of the same barriers as Phase I patients, with lower BMD testing rates (54.9% and 65.4%, respectively).Conclusion.Evaluating and addressing barriers to guideline implementation reduced those barriers and was associated with higher downstream treatment rates. Monitoring barriers in a program like this provides useful insights for program changes and research interventions.

Objective: To design and preliminarily test a questionnaire intended to measure patient treatment burden resulting from participation in cognitive assessments and interventions. Methods: An expert consensus process was used to develop the concept of patient treatment burden and to determine the first set of questionnaire items and administration protocol. The pilot questionnaire was administered to 20 patients with mild to severe acquired brain injuries on completion of a 2-h or longer neuropsychological assessment. Following preliminary testing, the questionnaire was revised and re-evaluated by a second expert panel and content validity was assessed. Results: Burden was defined as psychologically and/or physically aversive symptoms in response to cognitive assessment or intervention. The first questionnaire contained 21 items assigned to 3 categories: physical, cognitive, and emotional. Eighty-five percent of patients endorsed symptom level increases, with “tired/fatigued” the most frequently endorsed item (80% of patients). Instructions and test items were easily understood, and the questionnaire was quick to administer. Content validity ratio (CVR) of the revised questionnaire yielded 23 acceptable items and a subset met the highest CVR threshold (>0.78). Conclusion: This patient-reported outcome will ultimately help patients give voice to aversive experiences, and help clinicians and researchers to monitor and adapt assessments/treatments appropriately. Future steps in development are described.

Clinicians, researchers, and outcome stakeholders have the crucial, albeit difficult, task of quantifying when a person or group experiences important change or difference on any given outcome measure, often in response to a specific intervention. The minimal clinically important difference (MCID) provides this quantified value of change/difference for a measure. There are many methods for MCID derivation, which can result in multiple values for the same measure. Thus, it is important for potential users of MCID values to be aware of the nuances of MCID development and cautions for interpreting values. This review outlines MCID-related definitions, methods, and guidelines.

The aging of workforces combined with the prevalence of age-related chronic diseases has generated interest in whether large numbers of older workers will need workplace accommodations. This research applied work functioning theory to examine accommodation availability, need and use in workers with arthritis, diabetes, or no chronic disabling diseases; factors associated with accommodation needs; and the relationship of accommodation needs met, unmet or exceeded to job outcomes. Participants were aged 50–67 years, employed, and had arthritis (n = 631), diabetes (n = 286), both arthritis/diabetes (n = 111) or no chronic disabling conditions (healthy controls n = 538). They were recruited from a national panel of 80,000 individuals and a cross-sectional survey was administered online or by telephone. Questionnaires assessed demographics, health, work context, workplace accommodations, and job outcomes. Chi-square analyses, analyses of variance, and regression analyses compared groups. Respondents were similar in many demographic and work context factors. As expected, workers with arthritis and/or diabetes often reported poorer health and employment outcomes. Yet, there were few differences across health conditions in need for or use of accommodations with most participants reporting accommodations needs met. In keeping with work functioning theory, unmet accommodation needs were largely related to work context, not health. Workers whose accommodation needs were exceeded reported better job outcomes than those with accommodation needs met. Findings highlight both work context and health in understanding workplace accommodations and suggest that many older workers can meet accommodation needs with existing workplace practices. However, additional research aimed at workplace support and the timing of accommodation use is needed.

ObjectiveDispersion, or variability in an individual’s performance across multiple tasks at a single assessment visit, has been associated with cognitive dysfunction (CD) in many neurodegenerative and neurodevelopmental disorders. We aimed to compute a dispersion score using neuropsychological battery (NB) tests and determine its association with CD in patients with SLE.MethodsCD was defined as a z-score of ≤−1.5 on ≥2 domains of the NB. To compute a type of dispersion score known as the intraindividual SD (ISD), the SD of age-adjusted and sex-adjusted z-scores was calculated for each visit in each patient. To estimate the association between ISD and cognitive status (CD and non-CD), we used multilevel logistic regression, adjusting for clinically important covariates.ResultsA total of 301 adult patients with SLE completed the NB at baseline, 187 of whom were reassessed at 6 months and 189 at 12 months. CD was observed in 35.2% of patients at baseline, 27.8% at 6 months and 28.0% at 12 months. Prior to covariate adjustment, the mean ISD for non-CD was 1.10±0.31 compared with 1.50±0.70 for CD. After adjusting for ethnicity, education, employment, socioeconomic status and anxiety/depression, there was a statistically significant association between ISD and CD (OR for one-unit increase in ISD: 13.56, 95% CI 4.80 to 38.31; OR for 1/10th-unit increase in ISD: 1.30, 95% CI 1.17 to 1.44). Findings were valid across multiple sensitivity analyses.ConclusionThis is the first study to show that patients with SLE who were classified as having CD by the NB had more variability across the NB tests (ie, higher ISD score) compared with those who were not classified as having CD.

Objective.Despite advances integrating patient-centered outcomes into rheumatologic studies, concerns remain regarding their representativeness across diverse patient groups and how this affects equity. The Outcome Measures in Rheumatology (OMERACT) Equity Working Group aims to determine whether and how to address equity issues within the core outcome sets of domains and instruments.Methods.We surveyed current and previous OMERACT meeting attendees and members of the Campbell and Cochrane Equity Group regarding whether to address equity issues within the OMERACT Filter 2.0 Core Outcome Sets and how to assess the appropriateness of domains, instruments, and measurement properties among diverse patients. At OMERACT 2016, results of the survey and a narrative review of differential psychosocial effects of rheumatoid arthritis (i.e., on men) were presented to stimulate discussion and develop a research agenda.Results.We proposed 6 moments for which an equity lens could be added to the development, selection, or testing of patient-reported outcome measures (PROM): (1) recruitment, (2) domain selection, (3) feasibility in diverse settings, (4) instrument validity, (5) thresholds of meaning, and (6) consideration of statistical power of subgroup analyses for outcome reporting.Conclusion.There is a need to (1) conduct a systematic review to assess how equity and population characteristics have been considered in PROM development and whether these differences influence the ranking of importance of outcome domains or a patient’s response to questionnaire items, and (2) conduct the same survey described above with patients representing groups experiencing health inequities.

Objective.While there has been substantial progress in the development of core outcomes sets, the degree to which these are used by researchers is variable. We convened a special workshop on knowledge translation at the Outcome Measures in Rheumatology (OMERACT) 2016 with 2 main goals. The first focused on the development of a formal knowledge translation framework and the second on promoting uptake of recommended core outcome domain and instrument sets.Methods.We invited all 189 OMERACT 2016 attendees to the workshop; 86 attended, representing patient research partners (n = 15), healthcare providers/clinician researchers (n = 52), industry (n = 4), regulatory agencies (n = 4), and OMERACT fellows (n = 11). Participants were given an introduction to knowledge translation and were asked to propose and discuss recommendations for the OMERACT community to (1) strengthen stakeholder involvement in the core outcome instrument set development process, and (2) promote uptake of core outcome sets with a specific focus on the potential role of post-regulatory decision makers.Results.We developed the novel “OMERACT integrated knowledge translation” framework, which formalizes OMERACT’s knowledge translation strategies. We produced strategies to improve stakeholder engagement throughout the process of core outcome set development and created a list of creative and innovative ways to promote the uptake of OMERACT’s core outcome sets.Conclusion.The guidance provided in this paper is preliminary and is based on the views of the participants. Future work will engage OMERACT groups, “post-regulatory decision makers,” and a broad range of different stakeholders to identify and evaluate the most useful methods and processes, and to revise guidance accordingly.

Objective:To evaluate and update the evidence for the measurement properties of the Psoriatic Arthritis Impact of Disease (PsAID12) questionnaire to measure health-related quality of life (HRQoL) in psoriatic arthritis (PsA).Methods:The PsAID12 psychometric evidence was gathered in a systematic literature review in PsA (registration number: CRD42016032546). The study quality was appraised using the Consensus-based Standards for the selection of health Measurement Instruments–Outcome Measures in Rheumatology (COSMIN-OMERACT) good methods check-list. Content validity, test–retest reliability, construct validity, longitudinal construct validity, discrimination, and thresholds of meaning were appraised. Additional analyses for construct validity, responsiveness, and sensitivity to change were conducted in available observational data sets after prespecified hypotheses were formulated.Results:Eight publications (129-474 patients) were analyzed. The PsAID12 fulfilled OMERACT criteria for content validity (patients and physicians endorsed content match with PsA HRQoL domain), feasibility (endorsed by patients and physicians), and test–retest reliability (intraclass correlation coefficient: 0.91-0.95). A priori construct validity hypotheses were mostly met: Psoriatic Arthritis Impact of Disease had high correlation with generic ( r = 0.76-0.87) and PsA-specific HRQol measures (0.8), and with measures of physical function (0.66-0.72), work productivity (0.69-0.75), pain (0.83), and fatigue (0.84). Psoriatic Arthritis Impact of Disease had moderate-high correlation with measures of patient global (0.49-0.84) and dermatologic HRQoL (0.36-0.53). Correlations were higher with generic HRQoL measured by short form-36 physical component score (0.47-0.73) versus short form-36 mental component score (0.22-0.60). Three studies confirmed known group validity of PsAID12 according to PsA disease activity. Psoriatic Arthritis Impact of Disease discriminated between change groups in 2 longitudinal studies (standardized response mean: 0.74-0.91, 53 and 105 patients). The minimal clinically important improvement was 3 and 1.4 points.Conclusion:Psoriatic Arthritis Impact of Disease had evidence for good content and construct validity, reliability, and longitudinal construct validity and is ready to evaluate in clinical trials.

Purpose Employers increasingly are asked to accommodate workers living with physical and mental health conditions that cause episodic disability, where periods of wellness are punctuated by intermittent and often unpredictable activity limitations (e.g., depression, anxiety, arthritis, colitis). Episodic disabilities may be challenging for workplaces which must comply with legislation protecting the privacy of health information while believing they would benefit from personal health details to meet a worker’s accommodation needs. This research aimed to understand organizational perspectives on disability communication-support processes. Methods Twenty-seven participants from diverse employment sectors and who had responsibilities for supporting workers living with episodic disabilities (e.g., supervisors, disability managers, union representatives, occupational health representatives, labour lawyers) were interviewed. Five participants also had lived experience of a physical or mental health episodic disability. Participants were recruited through organizational associations, community networks and advertising. Semi-structured interviews and qualitative content analysis framed data collection and analyses, and mapped communication-support processes. Results Seven themes underpinned communication-support process: (1) similarities and differences among physical and mental health episodic disabilities; (2) cultures of workplace support, including contrasting medical and biopsychosocial perspectives; (3) misgivings about others and their role in communication-support processes; (4) that subjective perceptions matter; (5) the inherent complexity of the response process; (6) challenges arising when a worker denies a disability; and (7) casting disability as a performance problem. Conclusions This study identifies a conceptual framework and areas where workplace disability support processes could be enhanced to improve inclusion and the sustainability of employment among workers living with episodic disabilities.

KEY POINTS Emergency departments are a major point of access to timely care for Canadians, and yet little is known on the outcome of the care provided. Patients’ perspectives on the outcomes of their care could provide an untapped source of information for improvement. Past attempts at

Background We sought to report the prevalence of fragility fracture patients who were screened at high falls risk using a large provincial database, and to determine the characteristics associated with being screened at high falls risk. Methods The study population included fragility fracture patients 50+ years of age who were screened at 35 hospital fracture clinics in Ontario over a 3.5 year period. The outcome was based on two screening questions measuring the risk of falling, both adapted from the STEADI (Stopping Elderly Accidents, Deaths & Injuries) tool. Multivariable associations of sociodemographic, fracture-related, and health-related characteristics were evaluated using logistic regression. Results Of the sample, 9735 (44.5%) patients were classified as being at high falls risk, and 12,089 (55.3%) were not. In the multivariable logistic regression, being 80+ years of age (vs. 50–64 years of age), non-community dwelling (vs. living with spouse, family member, roommate), having a mental/physical impairment (vs. none), and taking multiple medications, were all strongly associated with being screened at high falls risk. Conclusions Living in a non-community dwelling and taking 4+ medications were the variables most strongly associated with being screened at high falls risk. These are potentially modifiable characteristics that should be considered when assessing falls risk in fragility fracture patients, and particularly when designing interventions for preventing subsequent falls. Ongoing work to address the higher risk of falls in the fragility fracture population is warranted.

Objectives To describe the experiences (including symptoms and perceived impacts on daily living) of people with a shoulder disorder. Methods Systematic review of qualitative studies. We searched for eligible qualitative studies indexed in Ovid MEDLINE, Ovid Embase, CINAHL (EBSCO), SportDiscus (EBSCO) and Ovid PsycINFO up until November 2017. Two authors independently screened studies for inclusion, appraised their methodological quality using the Critical Appraisal Skills Programme checklist, used thematic synthesis methods to generate themes describing the experiences reported by participants and assessed the confidence in the findings using the Grading of Recommendations Assessment, Development and Evaluation Confidence in Evidence from Reviews of Qualitative research (GRADE-CERQual) approach. Results The inclusion criteria were met by eight studies, which included 133 participants (49 females and 84 males) with either rotator cuff disease, adhesive capsulitis, proximal humeral fracture, shoulder instability or unspecified shoulder pain. We generated seven themes to describe what people in the included studies reported experiencing: pain; physical function/activity limitations; participation restriction; sleep disruption; cognitive dysfunction; emotional distress; and other pathophysiological manifestations (other than pain). There were interactions between the themes, with particular experiences impacting on others (e.g. pain leading to reduced activities and sleep disruption). Following grading of the evidence, we considered it likely that most of the review findings were a reasonable representation of the experiences of people with shoulder disorders. Conclusion Patients with shoulder disorders contend with considerable disruption to their life. The experiences described should be considered by researchers seeking to select the most appropriate outcomes to measure in clinical trials and other research studies in people with shoulder disorders.

Objective.Outcome Measures in Rheumatology (OMERACT) Filter 2.1 revised the process used for core outcome measurement set selection to add rigor and transparency in decision making. This paper describes OMERACT’s methodology for instrument selection.Methods.We presented instrument selection processes, tools, and reporting templates at OMERACT 2018, introducing the concept of “3 pillars, 4 questions, 7 measurement properties, 1 answer.” Truth, discrimination, and feasibility are the 3 original OMERACT pillars. Based on these, we developed 4 signaling questions. We introduced the Summary of Measurement Properties table that summarizes the 7 measurement properties: truth (domain match, construct validity), discrimination [test-retest reliability, longitudinal construct validity (responsiveness), clinical trial discrimination, thresholds of meaning], and feasibility. These properties address a set of standards which, when met, answer the one question: Is there enough evidence to support the use of this instrument in clinical research of the benefits and harms of treatments in the population and study setting described? The OMERACT Filter 2.1 was piloted on 2 instruments by the Psoriatic Arthritis Working Group.Results.The methodology was reviewed in a full plenary session and facilitated breakout groups. Tools to facilitate retention of the process (i.e., “The OMERACT Way”) were provided. The 2 instruments were presented, and the recommendation of the working group was endorsed in the first OMERACT Filter 2.1 Instrument Selection votes.Conclusion.Instrument selection using OMERACT Filter 2.1 is feasible and is now being implemented.

Objective.To reach consensus on the core domains to be included in a core domain set for clinical trials of shoulder disorders using the Outcome Measures in Rheumatology (OMERACT) Filter 2.1 Core Domain Set process.Methods.At OMERACT 2018, the OMERACT Shoulder Working Group conducted a workshop that presented the OMERACT 2016 preliminary core domain set and its rationale based upon a systematic review of domains measured in shoulder trials and international Delphi sessions involving patients, clinicians, and researchers, as well as a new systematic review of qualitative studies on the experiences of people with shoulder disorders. After discussions in breakout groups, the OMERACT core domain set for clinical trials of shoulder disorders was presented for endorsement by OMERACT 2018 participants.Results.The qualitative review (n = 8) identified all domains included in the preliminary core set. An additional domain, cognitive dysfunction, was also identified, but confidence that this represents a core domain was very low. The core domain set that was endorsed by the OMERACT participants, with 71% agreement, includes 4 “mandatory” trial domains: pain, function, patient global — shoulder, and adverse events including death; and 4 “important but optional” domains: participation (recreation/work), sleep, emotional well-being, and condition-specific pathophysiological manifestations. Cognitive dysfunction was voted out of the core domain set.Conclusion.OMERACT 2018 delegates endorsed a core domain set for clinical trials of shoulder disorders. The next step includes identification of a core outcome measurement set that passes the OMERACT 2.1 Filter for measuring each domain.