Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024.

PURPOSE: Although comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024. METHODS: The development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement. RESULTS: From the literature and expert consultation, 49 potentially relevant reporting items were identified. Round 1 of the Delphi study was completed by 103 panelists, whereas round 2 and 3 were completed by 78 panelists. After 3 rounds, agreement (≥ 67%) on inclusion and wording was reached for 44 items. Eleven items without consensus for inclusion and/or wording were discussed at a workgroup meeting attended by 24 participants. Agreement was reached for the inclusion and wording of 10 items, and the deletion of 1 item. Pilot testing with 65 authors of OMI systematic reviews further improved the guideline through minor changes in wording and structure, finalized during the end-of-project meeting. The final checklist to facilitate the reporting of full systematic review reports contains 54 (sub)items addressing the review's title, abstract, plain language summary, open science, introduction, methods, results, and discussion. Thirteen items pertaining to the title and abstract are also included in a separate abstract checklist, guiding authors in reporting for example conference abstracts. CONCLUSION: PRISMA-COSMIN for OMIs 2024 consists of two checklists (full reports; abstracts), their corresponding explanation and elaboration documents detailing the rationale and examples for each item, and a data flow diagram. PRISMA-COSMIN for OMIs 2024 can improve the reporting of systematic reviews of OMIs, fostering their reproducibility and allowing end-users to appraise the quality of OMIs and select the most appropriate OMI for a specific application. NOTE: In order to encourage its wide dissemination this article is freely accessible on the web sites of the journals: Health and Quality of Life Outcomes; Journal of Clinical Epidemiology; Journal of Patient-Reported Outcomes; Quality of Life Research.

Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024.

PURPOSE: Although comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024. METHODS: The development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement. RESULTS: From the literature and expert consultation, 49 potentially relevant reporting items were identified. Round 1 of the Delphi study was completed by 103 panelists, whereas round 2 and 3 were completed by 78 panelists. After 3 rounds, agreement (≥ 67%) on inclusion and wording was reached for 44 items. Eleven items without consensus for inclusion and/or wording were discussed at a workgroup meeting attended by 24 participants. Agreement was reached for the inclusion and wording of 10 items, and the deletion of 1 item. Pilot testing with 65 authors of OMI systematic reviews further improved the guideline through minor changes in wording and structure, finalized during the end-of-project meeting. The final checklist to facilitate the reporting of full systematic review reports contains 54 (sub)items addressing the review's title, abstract, plain language summary, open science, introduction, methods, results, and discussion. Thirteen items pertaining to the title and abstract are also included in a separate abstract checklist, guiding authors in reporting for example conference abstracts. CONCLUSION: PRISMA-COSMIN for OMIs 2024 consists of two checklists (full reports; abstracts), their corresponding explanation and elaboration documents detailing the rationale and examples for each item, and a data flow diagram. PRISMA-COSMIN for OMIs 2024 can improve the reporting of systematic reviews of OMIs, fostering their reproducibility and allowing end-users to appraise the quality of OMIs and select the most appropriate OMI for a specific application. NOTE: In order to encourage its wide dissemination this article is freely accessible on the web sites of the journals: Health and Quality of Life Outcomes; Journal of Clinical Epidemiology; Journal of Patient-Reported Outcomes; Quality of Life Research.

Systemic lupus erythematosus phenotypes formed from machine learning with a specific focus on cognitive impairment.

OBJECTIVE: To phenotype SLE based on symptom burden (disease damage, system involvement and patient reported outcomes), with a specific focus on objective and subjective cognitive function. METHODS: SLE patients ages 18-65 years underwent objective cognitive assessment using the ACR Neuropsychological Battery (ACR-NB) and data were collected on demographic and clinical variables, disease burden/activity, health-related quality of life (HRQoL), depression, anxiety, fatigue and perceived cognitive deficits. Similarity network fusion (SNF) was used to identify patient subtypes. Differences between the subtypes were evaluated using Kruskal-Wallis and χ2 tests. RESULTS: Of the 238 patients, 90% were female, with a mean age of 41 years (s.d. 12) and a disease duration of 14 years (s.d. 10) at the study visit. The SNF analysis defined two subtypes (A and B) with distinct patterns in objective and subjective cognitive function, disease burden/damage, HRQoL, anxiety and depression. Subtype A performed worst on all significantly different tests of objective cognitive function (P < 0.03) compared with subtype B. Subtype A also had greater levels of subjective cognitive function (P < 0.001), disease burden/damage (P < 0.04), HRQoL (P < 0.001) and psychiatric measures (P < 0.001) compared with subtype B. CONCLUSION: This study demonstrates the complexity of cognitive impairment (CI) in SLE and that individual, multifactorial phenotypes exist. Those with greater disease burden, from SLE-specific factors or other factors associated with chronic conditions, report poorer cognitive functioning and perform worse on objective cognitive measures. By exploring different ways of phenotyping SLE we may better define CI in SLE. Ultimately this will aid our understanding of personalized CI trajectories and identification of appropriate treatments.

Association of mycophenolate and azathioprine use with cognitive function in systemic lupus.

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.

A Sensibility Assessment of the Job Demands and Accommodation Planning Tool (JDAPT): A Tool to Help Workers with an Episodic Disability Plan Workplace Support.

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.

Validation of the automated neuropsychological assessment metrics for assessing cognitive impairment in systemic lupus erythematosus.

OBJECTIVE: We previously demonstrated the utility of the Automated Neuropsychological Assessment Metrics (ANAM) for screening cognitive impairment (CI) in patients with systemic lupus erythematosus (SLE) and developed composite indices for interpreting ANAM results. Our objectives here were to provide further support for the ANAM's concurrent criterion validity against the American College of Rheumatology neuropsychological battery (ACR-NB), identify the most discriminatory subtests and scores of the ANAM for predicting CI, and provide a new approach to interpret ANAM results using Classification and Regression Tree (CART) analysis. METHODS: 300 adult SLE patients completed an adapted ACR-NB and ANAM on the same day. As per objectives, six models were built using combinations of ANAM subtests and scores and submitted to CART analysis. Area under the curve (AUC) was calculated to evaluate the ANAM's criterion validity compared to the adapted ACR-NB; the most discriminatory ANAM subtests and scores in each model were selected, and performance of models with the highest AUCs were compared to our previous composite indices; decision trees were generated for models with the highest AUCs. RESULTS: Two models had excellent AUCs of 86 and 89%. Eight most discriminatory ANAM subtests and scores were identified. Both models demonstrated higher AUCs against our previous composite indices. An adapted decision tree was created to simplify the interpretation of ANAM results. CONCLUSION: We provide further validity evidence for the ANAM as a valid CI screening tool in SLE. The decision tree improves interpretation of ANAM results, enhancing clinical utility.

The Value Filter: A Novel Framework for Psychosocial Adjustment to Traumatic Upper Extremity Amputation.

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.

EULAR Points to Consider (PtC) for designing, analysing and reporting of studies with work participation as an outcome domain in patients with inflammatory arthritis.

BACKGROUND: Clinical studies with work participation (WP) as an outcome domain pose particular methodological challenges that hamper interpretation, comparison between studies and meta-analyses. OBJECTIVES: To 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. METHODS: The 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. RESULTS: Two 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). CONCLUSION: Adherence to these EULAR PtC will improve the methodological quality of studies evaluating WP.

Towards consensus in defining and handling contextual factors within rheumatology trials: an initial qualitative study from an OMERACT working group.

OBJECTIVES: The 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. METHODS: We 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. RESULTS: We 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. CONCLUSIONS: Two 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.

Validity and reliability of patient reported outcomes measurement information system computerized adaptive tests in systemic lupus erythematous.

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.

Disclosure, Privacy and Workplace Accommodation of Episodic Disabilities: Organizational Perspectives on Disability Communication-Support Processes to Sustain Employment.

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.

PROM-ED: Development and Testing of a Patient-Reported Outcome Measure for Emergency Department Patients Who Are Discharged Home.

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.

Factors associated with screening positive for high falls risk in fragility fracture patients: a cross-sectional study.

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.

Patients' experience of shoulder disorders: a systematic review of qualitative studies for the OMERACT Shoulder Core Domain Set.

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.

Systematic Review of Measurement Property Evidence for 8 Financial Management Instruments in Populations With Acquired Cognitive Impairment.

OBJECTIVES: To critically appraise the measurement property evidence (ie, psychometric) for 8 observation-based financial management assessment instruments. DATA SOURCES: Seven databases were searched in May 2015. STUDY SELECTION: Two reviewers used an independent decision-agreement process to select studies of measurement property evidence relevant to populations with adulthood acquired cognitive impairment, appraise the quality of the evidence, and extract data. Twenty-one articles were selected. DATA EXTRACTION: This review used the COnsensus-based Standards for the selection of health Measurement Instruments review guidelines and 4-point tool to appraise evidence. After appraising the methodologic quality, the adequacy of results and volume of evidence per instrument were synthesized. Measurement property evidence with high risk of bias was excluded from the synthesis. DATA SYNTHESIS: The volume of measurement property evidence per instrument is low; most instruments had 1 to 3 included studies. Many included studies had poor methodologic quality per measurement property evidence area examined. Six of the 8 instruments reviewed had supporting construct validity/hypothesis-testing evidence of fair methodologic quality. There is a dearth of acceptable quality content validity, reliability, and responsiveness evidence for all 8 instruments. CONCLUSIONS: Rehabilitation practitioners assess financial management functions in adults with acquired cognitive impairments. However, there is limited published evidence to support using any of the reviewed instruments. Practitioners should exercise caution when interpreting the results of these instruments. This review highlights the importance of appraising the quality of measurement property evidence before examining the adequacy of the results and synthesizing the evidence.

Content and Face Validity and Feasibility of 5 Candidate Instruments for Psoriatic Arthritis Randomized Controlled Trials: The PsA OMERACT Core Set Workshop at the GRAPPA 2017 Annual Meeting.

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis (PsA) Core Set working group is in the process of selecting core instruments for PsA clinical trials. During a 2-h workshop and breakout group discussions at the GRAPPA 2017 annual meeting in Amsterdam, the Netherlands, participants discussed the first set of candidate instruments to be taken through the OMERACT Filter 2.1 instrument selection process: 66/68 swollen/tender joint count (66/68JC), Spondyloarthritis Consortium of Canada (SPARCC) enthesitis index, patient's global assessment (GRAPPA and OMERACT formulations), Health Assessment Questionnaire-Disability Index (HAQ-DI), Psoriatic Arthritis Impact of Disease (PsAID) questionnaires 9 and 12, and Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue. Based on the assessment of domain match (content and face validity) and feasibility according to the OMERACT instrument selection criteria, the working group recommends continuing with appraisal of construct validity and discrimination for 66/68JC, SPARCC, PsAID 9 and 12, HAQ-DI, and FACIT-Fatigue. In addition, it recommends repeating the OMERACT Filter 2.1 process for patient global instruments because of insufficient votes. Additional sets of candidate instruments for the PsA core instrument set will be evaluated in a similar process.

Patients' Perspectives on Outcomes of Care After Discharge From the Emergency Department: A Qualitative Study.

STUDY OBJECTIVE: Much effort has been expended to understand what care experiences patients value in the emergency department (ED), yet little is known about which outcomes patients value after ED care. Our goal is to define outcomes of ED care that are valued by patients discharged from the ED, with the goal of informing the development of a patient-reported outcome measure for ED care. METHODS: We conducted qualitative semistructured interviews with patients recruited during their care at 1 of 2 EDs and interviewed in either English or French 1 to 9 days after their visit. Patients who were hospitalized were excluded. Interviews focused on perceived outcomes of care since the ED visit and expectations of care before the ED visit. We identified themes with standard descriptive content analysis techniques and a modified version of the constant comparative method, drawing on grounded theory methods. RESULTS: We interviewed 46 patients in English (n=38) or French (n=8). Participants with diverse reasons for seeking care appeared to value common outcomes from ED care that centered around 4 themes: understanding the cause and expected trajectory of their symptoms; reassurance; symptom relief; and having a plan to manage their symptoms, resolve their issue, or pursue further medical care. These themes were also reflected in the expectations participants recalled having when they decided to seek care in the ED. CONCLUSION: The 4 outcomes defined constitute areas for improvement and will inform the development of an ED patient-reported outcome questionnaire. Consideration should be given to measuring patient-reported outcomes separately from patient experience.

Longitudinal examination of temporality in the association between chronic disease diagnosis and changes in work status and hours worked.

OBJECTIVES: To examine the longitudinal relationship between incidence of diagnosed chronic disease and work status and hours worked. METHODS: A dynamic cohort approach was taken to construct our study sample using the Canadian National Population Health Survey. Participant inclusion criteria included being employed and without a chronic health condition in the survey cycle prior to diagnosis, and participation in consecutive surveys following diagnosis. Each respondent was matched with up to 5 respondents without a diagnosed health condition. The direct and indirect associations between chronic disease and work status and hours worked following diagnosis were examined using probit and linear regression path models. Separate models were developed for arthritis, back problems, diabetes, hypertension and heart disease. RESULTS: We identified 799 observations with a diagnosis of arthritis, 858 with back pain, 178 with diabetes, 569 with hypertension and 163 with heart disease, which met our selection criteria. An examination of total effects at time 1 and time 2 showed that, excluding hypertension, chronic disease diagnosis was related to work loss. The time 2 effect of chronic disease diagnosis on work loss was mediated through time 1 work status. With the exception of heart disease, an incident case of chronic disease was not related to changes in work hours among observations with continuous work participation. CONCLUSIONS: Chronic disease can result in work loss following diagnosis. Research is required to understand how modifying occupational conditions may benefit employment immediately after diagnosis.

A user's survey of the clinical application and content validity of the DASH (Disabilities of the Arm, Shoulder and Hand) outcome measure.

STUDY DESIGN: Survey. PURPOSE OF THE STUDY: To elicit feedback on the clinical use and content validity of the Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure from frontline users of the instrument. METHODS: A cross-sectional survey was administered to registered DASH users and inquired about how the DASH was being used and to identify the informational value of items of the DASH (content validity). RESULTS: About 172 completed the survey. One or both of the DASH and/or QuickDASH were consistently (89.5%) being used. About 90% were using it in adults (21-65 years), and at least 70% were using it across the entire extremity, and to a lesser extent, 10% reported using it in isolated neck injuries. Most respondents (66.9%-75.8%) were using the DASH in musculoskeletal (MSK) disorders, with some applying it for other more unique or non-MSK conditions (2.5%-16.6%). All but 1 of the 30 DASH items had at least 10% endorsement as being informative, and 4 items were identified as being problematic by greater than 20%. CONCLUSIONS: The DASH is being used as intended (whole extremity and MSK conditions), and in addition, it is being used in different body regions and diverse conditions. LEVEL OF EVIDENCE: Not applicable (descriptive survey).

Effects of client-centered multimodal treatment on impairment, function, and satisfaction of people with thumb carpometacarpal osteoarthritis.

STUDY DESIGN: Prepost design. INTRODUCTION: Previous research regarding the non-surgical treatment of thumb carpometacarpal joint osteoarthritis has been based on protocol driven research designs that primarily examined impairment level changes. Exploration is therefore needed to determine the benefits of individually prescribed orthoses, joint protection and assistive device education programs that are based on the activities the person needs to regularly perform. PURPOSE OF THE STUDY: The primary objective of this study was to examine the effect of client-centered multimodal treatment on activity, participation, impairment, and satisfaction of people with thumb carpometacarpal joint osteoarthritis. METHODS: A total of 60 participants completed the study that used a prepost design. The Canadian Occupational Performance Measure (COPM) was used to identify the participants' performance and satisfaction concerning their self-identified occupational performance issues. Additional outcome measures that were used included the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, total active range of motion (TAROM), lateral pinch strength, and the visual analog scale for pain. All participants completed a client-centered 6-week program that consisted of the use of an orthosis, joint protection, and assistive device education as well as exercises. RESULTS: At 6 weeks after initiation of treatment, pain, pinch strength, TAROM, the DASH questionnaire and the performance and satisfaction scales of the COPM had significantly improved. The changes in pain, TAROM, and the performance and satisfaction scales of the COPM were all greater than the minimal clinically important difference. The changes in pain and lateral pinch strength were significantly associated with changes in activity and participation. DISCUSSION: This study demonstrated that a multimodal, client-centered treatment approach resulted in statistically and clinically significant improvement in pain, TAROM and performance and satisfaction as measured by the COPM. The improvement in pain was associated with the participants' improved ability to engage in activities assessed by the DASH. CONCLUSIONS: Our results support the use of client-centered treatment strategies that are targeted to control pain during meaningful activity when working with patients with thumb carpometacarpal joint osteoarthritis therapists. LEVEL OF EVIDENCE: 4.