During OMERACT 12, a workshop was held with the aim to endorse a core set of domains for 3 settings: clinical trials of symptom and structure modification and observational studies. Additional goals ...were to endorse a core set of contextual factors for these settings, and to define preliminary instruments for each core domain. Finally, an agenda for future research in hand osteoarthritis (OA) was to be proposed.
Literature reviews of preliminary instruments for each core domain of the proposed core set for hand OA in the settings described above. Literature review of radiographic scoring methods and modern imaging in hand OA were also performed. Proposed contextual factors for a core set were identified through 2 Delphi exercises with participation of hand OA experts, patient partners, and OMERACT participants.
Results from Delphi exercises and systematic literature reviews were presented and discussed. It was agreed that a preliminary core domain set for the setting clinical trials of symptom modification should contain at least "pain, physical function, patient global assessment, joint activity and hand strength." The settings clinical trial of structure modification and observational studies would in addition include structural damage. Preliminary instruments for the proposed domains were agreed on. A list of prioritized contextual factors was defined and endorsed for further research. A research agenda was proposed for domain instrument validation according to the OMERACT Filter 2.0.
Preliminary core sets for clinical trials of symptom and structure modification and observational studies in hand osteoarthritis, including preliminary instruments and contextual factors, were agreed upon during OMERACT 12.
The interpretability of the six-minute walk test (6MWT) in individuals with knee osteoarthritis (OA) is unclear. We aimed to determine the minimal clinically important difference (MCID) for ...improvement in 6MWT in persons with knee OA at 12 months after total knee arthroplasty (TKA), and if it differed by baseline walking ability.
Participants with knee OA were assessed 1 month pre- and 12 months post-TKA, including completion of 6MWT. At 12 months, participant-perceived change in walking ability was assessed on an 8-point Likert scale ranging from "extremely worse" to "extremely better". Using logistic regression, ROC curves examined the ability of change in 6MWT distance to discriminate those who perceived walking was improved. MCID was selected overall and then by quartile of baseline 6MWT distance using the Youden method.
Two hundred seventy-eight participants were included: mean age 67 years (SD 8.5), 65.5% female, mean pre-TKA 6MWT distance 323.1 (SD 104.7) m, and mean 12-mo 6MWT distance 396.0 (SD 111.9) m. The overall MCID was 74.3 m (AUC 0.65). Acceptable model discrimination (AUC > 0.70) was achieved for individuals in the lowest quartiles of baseline 6MWT distance: Quartile 1: MCID 88.63 m (AUC 0.73); Quartile 2: MCID 84.47 m (AUC 0.72).
In persons with knee OA 12 months post-TKA, 6MWT MCID is dependent on baseline walking ability. Poor model discrimination for those in the highest (best) quartiles of baseline walking ability raise questions about 6MWT use across the full spectrum of walking ability. Further research is needed to better understand use of 6MWT as a performance-based measure of physical function for persons with knee OA.
The management of complex, multi-morbid patients is challenging for solo primary care providers (PCPs) with limited access to resources. The primary objective of the intervention was to reduce the ...overall rate of Emergency Department (ED) visits among patients in participating practices.
An interrupted time series design and qualitative interviews were used to evaluate a multifaceted intervention, SCOPE (Seamless Care Optimizing the Patient Experience), offered to solo PCPs whose patients were frequent users of the ED. The intervention featured a navigation hub (nurse, homecare coordinator) to link PCPs with hospital and community resources, a general internist on-call to provide phone advice or urgent assessments, and access to patient results on-line. Continuous quality improvement (QI) strategies were employed to optimize each component of the intervention. The primary outcome was the relative pre-post intervention change in ED visit rate for patients of participating practices compared with that for a propensity-matched control group of physicians over the contemporaneous period. Themes were identified from semi-structured interviews on PCP's experiences and influential factors in their engagement. Twenty-nine physicians agreed to participate and were provided access to the intervention over an 18-month time period. There were a total of 1,525 intervention contacts over the 18-months (average: 50.6±60.8 per PCP). Both intervention and control groups experienced a trend towards lower rates of ED use by their patients over the study time period. The pre-post difference in trend for the intervention group compared to the controls was not significant at 1.4% per year (RR = 1.014; p = 0.59). Several themes were identified from qualitative interviews including: PCPs felt better supported in the care of their patients; they experienced a greater sense of community, and; they were better able to provide shared primary-specialty care.
This multifaceted intervention to support solo PCPs in the management of their complex patients did not result in a reduced rate of ED visits compared to controls, likely related to variable uptake among PCPs. It did however result in more comprehensive and coordinated care for their patients. Future directions will focus on increasing uptake by improving ease of use, increasing the range of services offered and expanding to a larger number of PCPs.
ObjectivesIncreasingly, there is emphasis on identifying and initiating treatment of osteoarthritis (OA) in the early phases of the disease. This study aimed to identify the perceived barriers and ...facilitators to managing clients with early knee OA and the contextual factors affecting implementation of care by physical therapists (PTs).DesignQualitative study using in-depth semistructured interviews with 33 PTs. The interviews were audio-recorded, transcribed verbatim and analysed inductively using thematic analysis.SettingCanada.ParticipantsA purposive sample of PTs who managed clients with knee symptoms and/or diagnosed knee OA in community/outpatient settings in three provinces in Canada (Ontario, Alberta, British Columbia).ResultsFactors that affected physical therapy management of early knee OA were identified at four levels: the community, healthcare system, healthcare provider and client level. Some healthcare provider factors acted primarily as enablers of management, such as PTs’ confidence in their ability to manage perceived early knee OA, PTs’ beliefs about consequences of OA and the PT scope of practice. However, the study illuminated a range of modifiable factors that can act as barriers to management. These factors included access to services in the community and healthcare system; healthcare provider factors such as time, access to evidence and physician’s role in referrals and messaging; and client factors related to client characteristics (eg, general health, socioeconomic status), engagement in management and beliefs about OA.ConclusionThese findings provide us with a basis to begin to address specific barriers and to optimise care for early knee OA.
Abstract Objective Bayesian analysis can incorporate clinicians' beliefs about treatment effectiveness into models that estimate treatment effects. Many elicitation methods are available, but it is ...unclear if any confer advantages based on principles of measurement science. We review belief-elicitation methods for Bayesian analysis and determine if any of them had an incremental value over the others based on its validity, reliability, and responsiveness. Study Design and Setting A systematic review was performed. MEDLINE, EMBASE, CINAHL, Health and Psychosocial Instruments, Current Index to Statistics, MathSciNet, and Zentralblatt Math were searched using the terms (prior OR prior probability distribution) AND (beliefs OR elicitation) AND (Bayes OR Bayesian). Studies were evaluated on: design, question stem, response options, analysis, consideration of validity, reliability, and responsiveness. Results We identified 33 studies describing methods for elicitation in a Bayesian context. Elicitation occurred in cross-sectional studies ( n = 30, 89%), to derive point estimates with individual-level variation ( n = 19; 58%). Although 64% ( n = 21) considered validity, 24% ( n = 8) reliability, 12% ( n = 4) responsiveness of the elicitation methods, only 12% ( n = 4) formally tested validity, 6% ( n = 2) tested reliability, and none tested responsiveness. Conclusions We have summarized methods of belief elicitation for Bayesian priors. The validity, reliability, and responsiveness of elicitation methods have been infrequently evaluated. Until comparative studies are performed, strategies to reduce the effects of bias on the elicitation should be used.
There has been growing interest in the potential role for allopurinol to reduce cardiovascular events in people with diabetes. While adherence to allopurinol is poor in those with gout, our aim was ...to characterize persistence, patterns of use, and predictors of allopurinol use in a population-based cohort of individuals with diabetes and gout.
Individuals with diabetes older than 66 (thus eligible for prescription medication coverage) and newly prescribed allopurinol were followed for up to three years in a retrospective cohort study. Allopurinol use patterns were categorized as adherer (used continuously throughout follow-up), interrupter (non-persistent but subsequently resumed), or discontinuer (non-persistent with no subsequent resumption). Main outcomes were allopurinol non-persistence (no subsequent prescription accounting for a grace period), and indicators of gout severity throughout follow-up (prescriptions for prednisone or colchicine, outpatient gout visits, hospitalization/emergency department visits for gout). Outcome frequencies were determined, a multivariable Cox proportional hazards model evaluated associations between predictors and non-persistence, and zero-inflated negative binomial (ZINB) models evaluated associations between allopurinol use pattern and indicators of gout severity.
22,056 individuals were followed for a maximum of 3.0 years (17,410 with 3 years of follow-up). 9092 (41.2%) were non-persistent with allopurinol. Higher risks of non-persistence were associated with female sex (HR, 95% CI: 1.28, 1.23–1.33), dementia (1.23, 1.11–1.35), and an outpatient visit for gout in the prior year (1.19, 1.09–1.29). There were 12,964 (58.8%) allopurinol adherers, 4618 interrupters (20.9%), and 4474 (20.3%) discontinuers. Allopurinol interrupters and discontinuers had indicators of more severe gout over time compared to adherers, including greater odds of being prescribed prednisone.
Allopurinol non-persistence and interruptions were frequent in individuals with diabetes and gout and were associated with prescriptions for prednisone. Suboptimal allopurinol adherence may not only increase the risk of gout complications in this population but also potentially diabetes complications through greater prednisone use and its negative effects on glycemic control.
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The design, analysis, and interpretation of cluster randomized clinical trials (RCTs) require accounting for potential correlation of observations on individuals within the same cluster. Reporting of ...observed intracluster correlation coefficients (ICCs) in cluster RCTs, as recommended by Consolidated Standards of Reporting Trials (CONSORT), facilitates sample size calculation of future cluster RCTs and understanding of the trial statistical power. Our objective was to summarize observed ICCs in osteoarthritis (OA) cluster RCTs.
Systematic review of knee/hip OA cluster RCTs. We searched Cochrane Central Register of Controlled Trials for trials published from 2012, when CONSORT cluster RCTs extension was published, to September 2022. We calculated the proportion of cluster RCTs that reported observed ICCs. Of those that did, we extracted observed ICCs. PROSPERO: CRD42022365660.
We screened 1121 references and included 20 cluster RCTs. Only 5 trials (25%) reported the observed ICC for at least one outcome variable. ICC values for pain outcomes were: 0, 0.01, 0.18; for physical function outcomes were: 0, 0.06, 0.13 (knee)/0.27 (hip); Western Ontario and McMaster Universities Arthritis Index (WOMAC) total: 0.02, 0.02; symptoms of anxiety/depression: 0.22; disability: 0; and global change: 0. One out of four (25%) trials reported an ICC that was larger than the ICC used for sample size calculation and thus was underpowered.
Despite CONSORT statement recommendations for reporting cluster RCTs, few OA trials reported the observed ICC. Given the importance of the ICC to interpretation of trial results and future trial design, this reporting gap warrants attention.
Objective
To evaluate whether osteoarthritis (OA) pain determines depressed mood, taking into consideration fatigue and disability and controlling for other factors.
Methods
In a community cohort ...with hip/knee OA, telephone interviews assessed OA pain and disability (Western Ontario and McMaster Universities Osteoarthritis Index WOMAC), fatigue (Multidimensional Fatigue Symptom Inventory), depressed mood (Center for Epidemiologic Studies Depression Scale), and covariates (demographics, self‐rated health, comorbidity, pain coping, pain catastrophizing, and social support) at 3 time points over 2 years. Drawing on previous research, a path model was developed to test the interrelationships among the key concepts (pain, depression, fatigue, disability) over time, controlling for covariates.
Results
The baseline mean age was 75.4 years; 78.5% of the subjects were women, 37.2% were living alone, and 15.5% had ≥3 comorbid conditions. WOMAC scores indicated moderate OA symptoms and disability. From the final model with 529 subjects, adjusting for covariates, we found that current OA pain strongly predicted future fatigue and disability (both short and long term), that fatigue and disability in turn predicted future depressed mood, that depressed mood and fatigue were interrelated such that depressed mood exacerbated fatigue and vice versa, and that fatigue and disability, but not depressed mood, led to worsening of OA pain.
Conclusion
Controlling for other factors, OA pain determined subsequent depressed mood through its effect on fatigue and disability. These effects led to worsening of pain and disability over time. These results support the need for improved pain management in OA to prevent or attenuate the downstream effects of pain on disability and mood.
Abstract Background Bone loss in amenorrheic athletes has been attributed to energy deficiency-related suppression of bone formation, but not increased resorption despite hypoestrogenism. Objective ...To assess the independent and combined effects of energy deficiency and estrogen deficiency on bone turnover markers in exercising women. Design PINP, osteocalcin, U-CTX-I, TT3 , leptin, and ghrelin were measured repeatedly, and bone mineral density (BMD) was measured once in 44 exercising women. Resting energy expenditure (REE) was used to determine energy status (deficient or replete) and was corroborated with measures of metabolic hormones. Daily levels of urinary estrone and pregnanediol glucuronides (E1G, PdG), were assessed to determine menstrual and estrogen status. Volunteers were then retrospectively categorized into 4 groups: 1) Energy Replete + Estrogen Replete (EnR + E2 R), ( n = 22), 2) Energy Replete + Estrogen Deficient (EnR + E2 D), ( n = 7), 3) Energy Deficient + Estrogen Replete (EnD + E2 R), ( n = 7), and 4) Energy Deficient + Estrogen Deficient (EnD + E2 D), ( n = 8). Results The groups were similar ( p > 0.05) with respect to age (24.05 ± 1.75 yrs), weight (57.7 ± 2.2 kg), and BMI (21.05 ± 0.7 kg/m2 ). By design, REE/FFM ( p = 0.028) and REE:pREE ( p < 0.001) were lower in the EnD vs. EnR group, and the E2 D group had a lower REE:pREE ( p = 0.005) compared to the E2 R group. The EnD + E2 D group had suppressed PINP ( p = 0.034), and elevated U-CTX-I ( p = 0.052) and ghrelin ( p = 0.028) levels compared to the other groups. These same women also had convincing evidence of energy conservation, including TT3 levels that were 29% lower ( p = 0.057) and ghrelin levels that were 44% higher ( p = 0.028) than that observed in the other groups. Energy deficiency was associated with suppressed osteocalcin, and TT3 ( p < 0.05), whereas estrogen deficiency was associated with decreased E1G ( p < 0.02), and lower L2–L4 BMD ( p = 0.033). Leptin was significant in predicting markers of bone formation, but not markers of bone resorption. Conclusions When the energy status of exercising women was adequate (replete), there were no apparent perturbations of bone formation or resorption, regardless of estrogen status. Estrogen deficiency in exercising women, in the presence of an energy deficiency, was associated with bone loss and involved suppressed bone formation and increased bone resorption. These findings underscore the importance of avoiding energy deficiency, which is associated with hypoestrogenism, to avoid bone health problems.
Individually calibrated biomechanical footwear therapy may improve pain and physical function in people with symptomatic knee osteoarthritis, but the benefits of this therapy are unclear.
To assess ...the effect of a biomechanical footwear therapy vs control footwear over 24 weeks of follow-up.
Randomized clinical trial conducted at a Swiss university hospital. Participants (N = 220) with symptomatic, radiologically confirmed knee osteoarthritis were recruited between April 20, 2015, and January 10, 2017. The last participant visit occurred on August 15, 2017.
Participants were randomized to biomechanical footwear involving shoes with individually adjustable external convex pods attached to the outsole (n = 111) or to control footwear (n = 109) that had visible outsole pods that were not adjustable and did not create a convex walking surface.
The primary outcome was knee pain at 24 weeks of follow-up assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscore standardized to range from 0 (no symptoms) to 10 (extreme symptoms). The secondary outcomes included WOMAC physical function and stiffness subscores and the WOMAC global score, all ranging from 0 (no symptoms) to 10 (extreme symptoms) at 24 weeks of follow-up, and serious adverse events.
Among the 220 randomized participants (mean age, 65.2 years SD, 9.3 years; 104 women 47.3%), 219 received the allocated treatment and 213 (96.8%) completed follow-up. At 24 weeks of follow-up, the mean standardized WOMAC pain subscore improved from 4.3 to 1.3 in the biomechanical footwear group and from 4.0 to 2.6 in the control footwear group (between-group difference in scores at 24 weeks of follow-up, -1.3 95% CI, -1.8 to -0.9; P < .001). The results were consistent for WOMAC physical function subscore (between-group difference, -1.1 95% CI, -1.5 to -0.7), WOMAC stiffness subscore (between-group difference, -1.4 95% CI, -1.9 to -0.9), and WOMAC global score (between-group difference, -1.2 95% CI, -1.6 to -0.8) at 24 weeks of follow-up. Three serious adverse events occurred in the biomechanical footwear group compared with 9 in the control footwear group (2.7% vs 8.3%, respectively); none were related to treatment.
Among participants with knee pain from osteoarthritis, use of biomechanical footwear compared with control footwear resulted in an improvement in pain at 24 weeks of follow-up that was statistically significant but of uncertain clinical importance. Further research would be needed to assess long-term efficacy and safety, as well as replication, before reaching conclusions about the clinical value of this device.
ClinicalTrials.gov Identifier: NCT02363712.
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