Defining domains: developing consensus-based definitions for foundational domains in OMERACT core outcome sets.

OBJECTIVE: To develop a set of detailed definitions for foundational domains commonly used in OMERACT (Outcome Measures in Rheumatology) core domain sets. METHODS: We identified candidate domain definitions from prior OMERACT publications and websites and publications of major organizations involved in outcomes research for six domains commonly used in OMERACT Core Domain Sets: pain intensity, pain interference, physical function, fatigue, patient global assessment, and health-related quality of life. We conducted a two-round survey of OMERACT working groups, patient research partners, and then the OMERACT Technical Advisory Group to establish their preferred domain definitions. Results were presented at the OMERACT 2023 Methodology Workshop, where participants discussed their relevant lived experience and identified potential sources of variability giving the needed detail in our domain definitions. RESULTS: One-hundred four people responded to both rounds of the survey, and a preferred definition was established for each of the domains except for patient global assessment for which no agreement was reached. Seventy-five participants at the OMERACT 2023 Methodology Workshop provided lived experience examples, which were used to contextualise domain definition reports for each of the five domains. CONCLUSION: Using a consensus-based approach, we have created a detailed definition for five of the foundational domains in OMERACT core domain sets; patient global assessment requires further research. These definitions, although not mandatory for working groups to use, may facilitate the initial domain-match assessment step of instrument selection, and reduce the time and resources required by future OMERACT groups when developing core outcome sets.

Increasing uptake through collaboration in the development of core outcome sets: Lessons learned at OMERACT 2023.

OBJECTIVE: This manuscript highlights the importance of enhancing the uptake of Core Outcome Sets (COS) by building partnerships with Collaborators and addressing their needs in COS development. METHODS AND SETTING: This session was structured as a simulation, resembling a format akin to a classic television game show. The moderator posed a series of questions to eight different Collaborator groups who briefly described the importance of COS within their areas of interest. Previous studies examining the uptake of individual core outcomes revealed disparities in uptake rates. The Identified barriers to the uptake of COS include the lack of recommendations for validated instruments for each domain, insufficient involvement of patients and key Collaborator groups in COS development, and a lack of awareness regarding the existence of COS. CONCLUSIONS: This analysis underscores the need for COS development approaches that prioritize the inclusion of patients and diverse Collaborator groups at every stage. While current studies on COS uptake are limited, future research should explore the broader implementation of COS across diverse disease categories and delve into the factors that hinder or facilitate their uptake such as, the importance of COS developers extending their work to recommending domains with well validated instruments. Embracing patient leadership and multifaceted engagement is essential for advancing the relevance and impact of COS in clinical research.

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.

Assessing the Utility of the Montreal Cognitive Assessment in Screening for Cognitive Impairment in Patients With Systemic Lupus Erythematosus.

OBJECTIVE: 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). METHODS: 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. RESULTS: 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%. CONCLUSION: 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.

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.

Composite outcomes at OMERACT: Multi-outcome domains and composite outcome domains.

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.

Longitudinal relationships between cognitive domains and depression and anxiety symptoms in systemic lupus erythematosus.

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.

Core outcome measurement instrument selection for physical function in hand osteoarthritis using the OMERACT Filter 2.1 process.

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.

The evolution of instrument selection for inclusion in core outcome sets at OMERACT: Filter 2.2.

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.

Improving domain definition and outcome instrument selection: Lessons learned for OMERACT from imaging.

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.

Metrics and definitions used in the assessment of cognitive impairment in systemic lupus erythematosus: A systematic review.

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.

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.

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.

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.

Men and Women's Occupational Activities and the Risk of Developing Osteoarthritis of the Knee, Hip, or Hands: A Systematic Review and Recommendations for Future Research.

OBJECTIVE: To systematically review the evidence for an increased risk of osteoarthritis in the hip, knee, hand, wrist, finger, ankle, foot, shoulder, neck, and spine related to diverse occupational activities of men and women and to examine dose-response information related to the frequency, intensity, and duration of work exposures and the risk of osteoarthritis (OA). METHODS: Established guidelines for systematic reviews in occupational health and safety studies were followed. MEDLINE, Embase, CINAHL, and Cochrane Library were searched from inception to December 2017. Studies were reviewed for relevance, quality was appraised, and data were extracted and synthesized. RESULTS: Sixty-nine studies from 23 countries yielded strong and moderate evidence for lifting, cumulative physical loads, full-body vibration, and kneeling/squatting/bending as increasing the risks of developing OA in men and women. Strong and moderate evidence existed for no increased risk of OA related to sitting, standing, and walking (hip and knee OA), lifting and carrying (knee OA), climbing ladders (knee OA), driving (knee OA), and highly repetitive tasks (hand OA). Variability in dose-response data resulted in an inability to synthesize these data. CONCLUSION: Evidence points to the potential for OA occupational recommendations and practice considerations to be developed for women and men. However, research attention is needed to overcome deficits in the measurement and recall of specific work activities so that recommendations and practice considerations can provide the specificity needed to be adopted in workplaces.

"I Don't Have to Think About Watching the Ground": A Qualitative Study Exploring the Concept of Vigilance as an Important Outcome for Ankle Reconstruction.

OBJECTIVE: To understand patients' experiences of ankle reconstruction for treatment of end-stage ankle osteoarthritis. METHODS: Individuals were recruited from a cohort of individuals who had undergone total ankle replacement or ankle fusion. English-speaking individuals who had surgery at least 1 year prior were invited to participate. Semistructured, face-to-face interviews relying on a phenomenological approach were conducted in a private hospital clinic room. RESULTS: A total of 25 adults (12 women, 13 men), ages 25-82 years, were interviewed for 1-2 hours. Participants commonly described a state of having to keep careful watch for potential environmental challenges. Vigilance was related to ongoing symptoms (i.e., pain, stiffness) and concerns regarding balance, stability, and potential damage to the fused ankle or implant. Vigilance was described along a continuum, with higher levels associated with stress and mental exhaustion. Vigilance affected participants' perception of their surgical outcome, with high vigilance levels linked to negative perceptions of outcome. The degree to which individuals perceived the need for vigilance was influenced by environmental factors like uneven ground or crowds. Contrary to descriptions of vigilance in the coping literature, vigilance related to ankle reconstruction constituted a situational, rather than dispositional, response. CONCLUSION: Vigilance and its associated burden are not captured by current instruments. The mental load and worry associated with vigilance was important to patients, distinct from related pain or functional status. Thus, reducing high levels of vigilance appears to be an appropriate target for patient-centered treatment outcomes. A thorough battery of outcome measures for ankle reconstruction should consider this domain.

Validity Evidence for the Use of Automated Neuropsychologic Assessment Metrics As a Screening Tool for Cognitive Impairment in Systemic Lupus Erythematosus.

OBJECTIVE: Screening for cognitive impairment in systemic lupus erythematosus (SLE) conventionally relies on the American College of Rheumatology (ACR) neuropsychologic battery (NB), which is not universally available. To develop a more accessible screening approach, we assessed validity of the Automated Neuropsychological Assessment Metrics (ANAM). Using the ACR NB as the gold standard for cognitive impairment classification, the objectives were 1) to measure overall discriminative validity of the ANAM for cognitive impairment versus no cognitive impairment, 2) to identify ANAM subtests and scores that best differentiate patients with cognitive impairment from those with no cognitive impairment, and 3) to derive ANAM composite indices and cutoffs. METHODS: A total of 211 consecutive adult patients, female and male, with SLE were administered the ANAM and ACR NB. 1) For overall discriminative validity of the ANAM, we compared patients with cognitive impairment versus those with no cognitive impairment on 4 scores. 2) Six ANAM models using different scores were developed, and the most discriminatory subtests were selected using logistic regression analyses. The area under the receiver operating characteristic curve (AUC) was calculated to establish ANAM validity against the ACR NB. 3) ANAM composite indices and cutoffs were derived for the best models, and sensitivities and specificities were calculated. RESULTS: Patients with no cognitive impairment performed better on most ANAM subtests, supporting ANAM's discriminative validity. Cognitive impairment could be accurately identified by selected ANAM subtests with top models, demonstrating excellent AUCs of 81% and 84%. Derived composite indices and cutoffs demonstrated sensitivity of 78-80% and specificity of 70%. CONCLUSION: This study provides support for ANAM's discriminative validity for cognitive impairment and utility for cognitive screening in adult SLE. Derived composite indices and cutoffs enhance clinical applicability.

Risk of Recurrent Fracture: A Population-Based Study.

OBJECTIVES: To determine if children who sustain a fracture in childhood had an increased rate of fracture later in childhood or early adulthood. The a priori null hypothesis was that children who sustained a fracture would not have an increased rate of future fractures compared with children who did not sustain a fracture when controlling for important covariates. METHODS: This is a population-based retrospective cohort study using health care databases in Ontario. Approximately 2.5 million healthy children aged 0 to 15 years living in Ontario, Canada between April 1, 2003, and March 31, 2004, were included and followed for 7 years. The exposure was occurrence of any fracture during a 1-year baseline period. The main outcome was any fractures during a 7-year follow-up period. RESULTS: A total of 43 154 children suffered a fracture during the baseline year (17.5 fractures per 1000 child years). Children with a baseline fracture had a 60% higher rate of fracture (incidence rate ratio: 1.60; 95% confidence interval: 1.46-1.75; P < .0001) during the follow-up period after adjustment for sex, rurality, history of previous fracture, and the occurrence of other injuries (head and soft-tissue). CONCLUSIONS: The occurrence of a fracture during childhood was associated with an increased rate of future fractures compared with children who did not suffer a fracture. Attempting to improve childhood bone health by targeting children who present to a fracture clinic with multiple fracture risk factors may be a useful strategy for secondary prevention of fractures and may have beneficial effects on long-term bone health.