mRNA COVID-19 vaccine safety among older adults from the Canadian National Vaccine Safety Network.

This study examined short-to-medium term safety of COVID-19 vaccines among adults aged ≥65 years using the Canadian National Vaccine Safety Network active safety surveillance data. Both vaccinated and unvaccinated older adult participants recruited from seven provinces and territories were included in the analysis. Safety was assessed at 7 days after COVID-19 vaccination (dose 1, 2 and 3), and 7 months after dose 1. Multivariable logistic regression was used to examine the association between BNT162b2/mRNA-1273 COVID-19 vaccines and two short-term health events: 1) health event preventing daily activities and/or required medical consultation, 2) serious health events resulting in an emergency department visit and/or hospitalization within 7 days following each dose. We also assessed the rates of serious health events for the period between dose 1 and 2, and 7-months following dose 1. Between December 2020 and February 2022, a total of 173,038, 104,452, and 13,970 older adults completed dose 1, dose 2, and dose 3 surveys, respectively. The control survey was completed by 2,955 unvaccinated older adults. Health events occurred more frequently among recipients after dose 2 homologous mRNA-1273 (adjusted odds ratio [95 % confidence interval]: 2.91 [2.24-3.79]) and dose two heterologous (BNT162b2 followed by mRNA-1273): 1.50 [1.12-2.02] compared to unvaccinated counterparts. There was no difference in event rates after any dose of BNT162b2 and unvaccinated participants. The rates of serious health events following COVID-19 vaccination were very low (≤0.3 %) across all vaccine products and doses, and were not higher compared to unvaccinated controls, and were not associated with an emergency department visit or hospitalization within 7 days following vaccination. Reported symptoms were self-limited and rarely required medical assessment. Our findings further strengthen the current evidence that mRNA COVID-19 vaccines are safe and can be used to inform older adults about expected adverse events following COVID-19 vaccination.

Home Blood Pressure Telemonitoring Technology for Patients With Asymptomatic Elevated Blood Pressure Discharged From the Emergency Department: Pilot Study.

BACKGROUND: Hypertension affects 1 in 5 Canadians and is the leading cause of morbidity and mortality globally. Hypertension control is declining due to multiple factors including lack of access to primary care. Consequently, patients with hypertension frequently visit the emergency department (ED) due to high blood pressure (BP). Telehealth for Emergency-Community Continuity of Care Connectivity via Home-Telemonitoring Blood Pressure is a pilot project that implements and evaluates a comprehensive home blood pressure telemonitoring (HBPT) and physician case management protocol designed as a postdischarge management strategy to support patients with asymptomatic elevated BP as they transition from the ED to home. OBJECTIVE: Our objective was to conduct a feasibility study of an HBPT program for patients with asymptomatic elevated BP discharged from the ED. METHODS: Patients discharged from an urban, tertiary care hospital ED with asymptomatic elevated BP were recruited in Vancouver, British Columbia, Canada, and provided with HBPT technology for 3 months of monitoring post discharge and referred to specialist hypertension clinics. Participants monitored their BP twice in the morning and evenings and tele-transmitted readings via Bluetooth Sensor each day using an app. A monitoring clinician received these data and monitored the patient's condition daily and adjusted antihypertensive medications. Feasibility outcomes included eligibility, recruitment, adherence to monitoring, and retention rates. Secondary outcomes included proportion of those who were defined as having hypertension post-ED visits, changes in mean BP, overall BP control, medication adherence, changes to antihypertensive medications, quality of life, and end user experience at 3 months. RESULTS: A total of 46 multiethnic patients (mean age 63, SD 17 years, 69%, n=32 women) found to have severe hypertension (mean 191, SD 23/mean 100, SD 14 mm Hg) in the ED were recruited, initiated on HBPT with hypertension specialist physician referral and followed up for 3 months. Eligibility and recruitment rates were 40% (56/139) and 88% (49/56), respectively. The proportion of participants that completed ≥80% of home BP measurements at 1 and 3 months were 67% (31/46) and 41% (19/46), respectively. The proportion of individuals who achieved home systolic BP and diastolic BP control at 3 months was 71.4% (30/42) and 85.7% (36/42) respectively. Mean home systolic and diastolic BP improved by -13/-5 mm Hg after initiation of HBPT to the end of the study. Patients were prescribed 1 additional antihypertensive medication. No differences in medication adherence from enrollment to 3 months were noted. Most patients (76%, 25/33) were highly satisfied with the HBPT program and 76% (25/33) found digital health tools easy to use. CONCLUSIONS: HBPT intervention is a feasible postdischarge management strategy and can be beneficial in supporting patients with asymptomatic elevated BP from the ED. A randomized trial is underway to evaluate the efficacy of this intervention on BP control.

Age and sex-related comparison of referral-based telemedicine service utilization during the COVID-19 pandemic in Ontario: a retrospective analysis.

BACKGROUND: The COVID-19 pandemic has led to increased utilization of telemedicine services. METHODS: A retrospective analysis of all referral-based ambulatory telemedicine services in Ontario from November 2019 to June 2021 was collected from the Ontario Health Insurance Plan (OHIP) billing database. Only fee-for-service billings were included in the present analysis. Coincident COVID-19 cases were obtained from Public Health Ontario. Comparisons were made based on age bracket, sex, telemedicine and in-person care. RESULTS: Billings for telemedicine services in Ontario increased from $1.7 million CAD in November 2019 to $64 million CAD in April 2020 and the proportions reached a mean peak of 72% in April 2020 and declined to 46% in June 2021. A positive correlation was found between the use of telemedicine and COVID-19 cases (p = 0.05). The age group with the highest proportion of telemedicine use was the 10-20-year-olds, followed by the 20-50-year-olds (61 ± 9.0%, 55 ± 7.3%, p = 0.01). Both age groups remained above 50% telemedicine services at the end of the study period. There seemed to be higher utilization by females (females 54.2 ± 8.0%, males 47.9 ± 7.7%, ANCOVA p = 0.05) for all specialties, however, after adjusting for male to female ratio m:f of 0.952:1.0 according to the 2016 census, this was no longer significant. CONCLUSIONS: The use of telemedicine services remained at a high level across groups, particularly the 10-50-year-olds. There were clear age preferences for using telemedicine. Studying these differences may provide insights into how the delivery of non-hospital-based medicine has changed during the COVID-19 pandemic.

Supporting physical activity for mobility in older adults with mobility limitations (SuPA Mobility): study protocol for a randomized controlled trial.

BACKGROUND: Limited mobility in older adults consistently predicts both morbidity and mortality. As individuals age, the rates of mobility disability increase from 1.0% in people aged 15-24 to 20.6% in adults over 65 years of age. Physical activity can effectively improve mobility in older adults, yet many older adults do not engage in sufficient physical activity. Evidence shows that increasing physical activity by 50 min of moderate intensity physical activity in sedentary older adults with mobility limitations can improve mobility and reduce the incidence of mobility disability. To maximize the healthy life span of older adults, it is necessary to find effective and efficient interventions that can be delivered widely to prevent mobility limitations, increase physical activity participation, and improve quality of life in older adults. We propose a randomized controlled trial to assess the effect of a physical activity health coaching intervention on mobility in older adults with mobility limitations. METHODS: This randomized controlled trial among 290 (145 per group) community-dwelling older adults with mobility limitations, aged 70-89 years old, will compare the effect of a physical activity health coaching intervention versus a general healthy aging education program on mobility, as assessed with the Short Physical Performance Battery. The physical activity health coaching intervention will be delivered by exercise individuals who are trained in Brief Action Planning. The coaches will use evidence-based behavior change techniques including goal-setting, action planning, self-monitoring, and feedback to improve participation in physical activity by a known dose of 50 min per week. There will be a total of 9 health coaching or education sessions delivered over 26 weeks with a subsequent 26-week follow-up period, wherein both groups will receive the same duration and frequency of study visits and activities. DISCUSSION: The consequences of limited mobility pose a significant burden on the quality of life of older adults. Our trial is novel in that it investigates implementing a dose of physical activity that is known to improve mobility in older adults utilizing a health coaching intervention. TRIAL REGISTRATION: ClinicalTrials.gov Protocol Registration System: NCT05978336; registered on 28 July 2023.

Study of Rivaroxaban for Cerebral Venous Thrombosis: A Randomized Controlled Feasibility Trial Comparing Anticoagulation With Rivaroxaban to Standard-of-Care in Symptomatic Cerebral Venous Thrombosis.

BACKGROUND: Emerging data suggest that direct oral anticoagulants may be a suitable choice for anticoagulation for cerebral venous thrombosis (CVT). However, conducting high-quality trials in CVT is challenging as it is a rare disease with low rates of adverse outcomes such as major bleeding and functional dependence. To facilitate the design of future CVT trials, SECRET (Study of Rivaroxaban for Cerebral Venous Thrombosis) assessed (1) the feasibility of recruitment, (2) the safety of rivaroxaban compared with standard-of-care anticoagulation, and (3) patient-centered functional outcomes. METHODS: This was a phase II, prospective, open-label blinded-end point 1:1 randomized trial conducted at 12 Canadian centers. Participants were aged ≥18 years, within 14 days of a new diagnosis of symptomatic CVT, and suitable for oral anticoagulation; they were randomized to receive rivaroxaban 20 mg daily, or standard-of-care anticoagulation (warfarin, target international normalized ratio, 2.0-3.0, or low-molecular-weight heparin) for 180 days, with optional extension up to 365 days. Primary outcomes were annual rate of recruitment (feasibility); and a composite of symptomatic intracranial hemorrhage, major extracranial hemorrhage, or mortality at 180 days (safety). Secondary outcomes included recurrent venous thromboembolism, recanalization, clinically relevant nonmajor bleeding, and functional and patient-reported outcomes (modified Rankin Scale, quality of life, headache, mood, fatigue, and cognition) at days 180 and 365. RESULTS: Fifty-five participants were randomized. The rate of recruitment was 21.3 participants/year; 57% of eligible candidates consented. Median age was 48.0 years (interquartile range, 38.5-73.2); 66% were female. There was 1 primary event (symptomatic intracranial hemorrhage), 2 clinically relevant nonmajor bleeding events, and 1 recurrent CVT by day 180, all in the rivaroxaban group. All participants in both arms had at least partial recanalization by day 180. At enrollment, both groups on average reported reduced quality of life, low mood, fatigue, and headache with impaired cognitive performance. All metrics improved markedly by day 180. CONCLUSIONS: Recruitment targets were reached, but many eligible participants declined randomization. There were numerically more bleeding events in patients taking rivaroxaban compared with control, but rates of bleeding and recurrent venous thromboembolism were low overall and in keeping with previous studies. Participants had symptoms affecting their well-being at enrollment but improved over time. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03178864.

Duration of Adjunctive Antidepressant Maintenance in Bipolar I Depression.

BACKGROUND: Antidepressants are used to treat acute depression in patients with bipolar I disorder, but their effect as maintenance treatment after the remission of depression has not been well studied. METHODS: We conducted a multisite, double-blind, randomized, placebo-controlled trial of maintenance of treatment with adjunctive escitalopram or bupropion XL as compared with discontinuation of antidepressant therapy in patients with bipolar I disorder who had recently had remission of a depressive episode. Patients were randomly assigned in a 1:1 ratio to continue treatment with antidepressants for 52 weeks after remission or to switch to placebo at 8 weeks. The primary outcome, assessed in a time-to-event analysis, was any mood episode, as defined by scores on scales measuring symptoms of hypomania or mania, depression, suicidality, and mood-episode severity; additional treatment or hospitalization for mood symptoms; or attempted or completed suicide. Key secondary outcomes included the time to an episode of mania or hypomania or depression. RESULTS: Of 209 patients with bipolar I disorder who participated in an open-label treatment phase, 150 who had remission of depression were enrolled in the double-blind phase in addition to 27 patients who were enrolled directly. A total of 90 patients were assigned to continue treatment with the prescribed antidepressant for 52 weeks (52-week group) and 87 were assigned to switch to placebo at 8 weeks (8-week group). The trial was stopped before full recruitment was reached owing to slow recruitment and funding limitations. At 52 weeks, 28 of the patients in the 52-week group (31%) and 40 in the 8-week group (46%) had a primary-outcome event. The hazard ratio for time to any mood episode in the 52-week group relative to the 8-week group was 0.68 (95% confidence interval [CI], 0.43 to 1.10; P = 0.12 by log-rank test). A total of 11 patients in the 52-week group (12%) as compared with 5 patients in the 8-week group (6%) had mania or hypomania (hazard ratio, 2.28; 95% CI, 0.86 to 6.08), and 15 patients (17%) as compared with 35 patients (40%) had recurrence of depression (hazard ratio, 0.43; 95% CI, 0.25 to 0.75). The incidence of adverse events was similar in the two groups. CONCLUSIONS: In a trial involving patients with bipolar I disorder and a recently remitted depressive episode, adjunctive treatment with escitalopram or bupropion XL that continued for 52 weeks did not show a significant benefit as compared with treatment for 8 weeks in preventing relapse of any mood episode. The trial was stopped early owing to slow recruitment and funding limitations. (Funded by the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT00958633.).

T1Gd is reduced in bone marrow lesions overlying cartilage in the hip.

OBJECTIVE: Bone Marrow Lesions (BMLs) are areas in bone with high fluid signal on MRI associated with painful and progressive OA. While cartilage near BMLs in the knee has been shown to be degenerated, this relationship has not been investigated in the hip. RESEARCH QUESTION: is T1Gd lower in areas of cartilage overlying BMLs in the hip? DESIGN: 128 participants were recruited from a population-based study of hip pain in 20-49-year-olds. Proton-density weighted fat-suppressed and delayed Gadolinium Enhanced MR Imaging of Cartilage (dGEMRIC) images were acquired to locate BMLs and quantify hip cartilage health. BML and cartilage images were registered and cartilage was separated into BML overlying and surrounding regions. Mean T1Gd was measured in 32 participants with BMLs in both cartilage regions and in matched regions in 32 age- and sex-matched controls. Mean T1Gd in the overlying cartilage was compared using linear mixed-effects models between BML and control groups for acetabular and femoral BMLs, and between cystic and non-cystic BML groups. RESULTS: Mean T1Gd of overlying cartilage was lower in the BML group compared to the control group (acetabular: -105 ms; 95% CI: -175, -35; femoral: -8 ms; 95% CI: -141, 124). Mean T1Gd in overlying cartilage was lower in cystic compared to non-cystic BML subjects, but the confidence interval is too large to provide certainty in this difference (-3 [95% CI: -126, 121]). CONCLUSIONS: T1Gd is reduced in overlying cartilage in hips from a population-based sample of adults aged 20-49, which suggests BMLs are associated with local cartilage degeneration in hips.

Role of latent tuberculosis infection on elevated risk of cardiovascular disease: a population-based cohort study of immigrants in British Columbia, Canada, 1985-2019.

We investigated cardiovascular disease (CVD) risk associated with latent tuberculosis infection (LTBI) (Aim-1) and LTBI therapy (Aim-2) in British Columbia, a low-tuberculosis-incidence setting. 49,197 participants had valid LTBI test results. Cox proportional hazards model was fitted, adjusting for potential confounders. Compared with the participants who tested LTBI negative, LTBI positive was associated with an 8% higher CVD risk in complete case data (adjusted hazard ratio (HR): 1.08, 95% CI: 0.99-1.18), a statistically significant 11% higher risk when missing confounder values were imputed using multiple imputation (HR: 1.11, 95% CI: 1.02-1.20), and 10% higher risk when additional proxy variables supplementing known unmeasured confounders were incorporated in the highdimensional disease risk score technique to reduce residual confounding (HR: 1.10, 95% CI: 1.01-1.20). Also, compared with participants who tested negative, CVD risk was 27% higher among people who were LTBI positive but incomplete LTBI therapy (HR: 1.27, 95% CI: 1.04-1.55), whereas the risk was similar in people who completed LTBI therapy (HR: 1.04, 95% CI: 0.87-1.24). Findings were consistent in different sensitivity analyses. We concluded that LTBI is associated with an increased CVD risk in low-tuberculosis-incidence settings, with a higher risk associated with incomplete LTBI therapy and attenuated risk when therapy is completed.

Minimum important difference is minimally important in sample size calculations.

Performing a sample size calculation for a randomized controlled trial requires specifying an assumed benefit (that is, the mean improvement in outcomes due to the intervention) and a target power. There is a widespread belief that judgments about the minimum important difference should be used when setting the assumed benefit and thus the sample size. This belief is misguided - when the purpose of the trial is to test the null hypothesis of no treatment benefit, the only role that the minimum important difference should be given is in determining whether the sample size should be zero, that is, whether the trial should be conducted at all.The true power of the trial depends on the true benefit, so the calculated sample size will result in a true power close to the target power used in the calculation only if the assumed benefit is close to the true benefit. Hence, the assumed benefit should be set to a value that is considered a realistic estimate of the true benefit. If a trial designed using a realistic value for the assumed benefit is unlikely to demonstrate that a meaningful benefit exists, the trial should not be conducted. Any attempt to reconcile discrepancies between the realistic estimate of benefit and the minimum important difference when setting the assumed benefit merely conflates a valid sample size calculation with one based on faulty inputs and leads to a true power that fails to match the target power.When calculating sample size, trial designers should focus efforts on determining reasonable estimates of the true benefit, not on what magnitude of benefit is judged important.

Implementation of increased physical therapy intensity for improving walking after stroke: Walk 'n watch protocol for a multisite stepped-wedge cluster-randomized controlled trial.

RATIONALE: Clinical practice guidelines support structured, progressive protocols for improving walking after stroke. Yet, practice is slow to change, evidenced by the little amount of walking activity in stroke rehabilitation units. Our recent study (n = 75) found that a structured, progressive protocol integrated with typical daily physical therapy improved walking and quality-of-life measures over usual care. Research therapists progressed the intensity of exercise by using heart rate and step counters worn by the participants with stroke during therapy. To have the greatest impact, our next step is to undertake an implementation trial to change practice across stroke units where we enable the entire unit to use the protocol as part of standard of care. AIMS: What is the effect of introducing structured, progressive exercise (termed the Walk 'n Watch protocol) to the standard of care on the primary outcome of walking in adult participants with stroke over the hospital inpatient rehabilitation period? Secondary outcomes will be evaluated and include quality of life. METHODS AND SAMPLE SIZE ESTIMATES: This national, multisite clinical trial will randomize 12 sites using a stepped-wedge design where each site will be randomized to deliver Usual Care initially for 4, 8, 12, or 16 months (three sites for each duration). Then, each site will switch to the Walk 'n Watch phase for the remaining duration of a total 20-month enrolment period. Each participant will be exposed to either Usual Care or Walk 'n Watch. The trial will enroll a total of 195 participants with stroke to achieve a power of 80% with a Type I error rate of 5%, allowing for 20% dropout. Participants will be medically stable adults post-stroke and able to take five steps with a maximum physical assistance from one therapist. The Walk 'n Watch protocol focuses on completing a minimum of 30 min of weight-bearing, walking-related activities (at the physical therapists' discretion) that progressively increase in intensity informed by activity trackers measuring heart rate and step number. STUDY OUTCOME(S): The primary outcome will be the change in walking endurance, measured by the 6-Minute Walk Test, from baseline (T1) to 4 weeks (T2). This change will be compared across Usual Care and Walk 'n Watch phases using a linear mixed-effects model. Additional physical, cognitive, and quality of life outcomes will be measured at T1, T2, and 12 months post-stroke (T3) by a blinded assessor. DISCUSSION: The implementation of stepped-wedge cluster-randomized trial enables the protocol to be tested under real-world conditions, involving all clinicians on the unit. It will result in all sites and all clinicians on the unit to gain expertise in protocol delivery. Hence, a deliberate outcome of the trial is facilitating changes in best practice to improve outcomes for participants with stroke in the trial and for the many participants with stroke admitted after the trial ends.

Magnetic resonance imaging predictors (cartilage, osteophytes and meniscus) of prevalent and 3-year incident medial and lateral tibiofemoral knee joint tenderness and patellofemoral grind.

OBJECTIVE: To identify magnetic resonance imaging (MRI) predictors (cartilage [C], osteophytes [O] and meniscus [M] scores) of prevalent and 3-year incident medial tibiofemoral (MTF) and lateral tibiofemoral (LTF) knee joint tenderness and patellofemoral (PF) grind.  METHODS: Population-based knee pain cohort aged 40-79 was assessed at baseline (N = 255), 3- and 7-year follow-up (N = 108 × 2 = 216). COM scores were measured at 6/8/6 subregions respectively. Age-sex-BMI adjusted logistic models predicted prevalence versus relevant COM predictors (medial, lateral or patellar / trochlear groove scores). Fully adjusted models also included all relevant COM predictors. Binary generalized estimating equations models predicting 3-year incidence were also adjusted for individual follow-up time between cycles. RESULTS: Significant predictors of prevalent MTF tenderness: medial femoral cartilage (fully adjusted odds ratio [aOR] 1.84; 95% confidence interval [CI] 1.11, 3.05), female (aOR = 3.05; 1.67, 5.58), BMI (aOR = 1.53 per 5 units BMI; 1.10, 2.11). Predictors of prevalent LTF tenderness: female (aOR = 2.18; 1.22, 3.90). There were no predictors of prevalent PF grind in the fully adjusted model. However, medial patellar osteophytes was predictive in the age-sex-BMI adjusted model. There were no predictors of 3-year incident MTF tenderness. Predictors of 3-year incident LTF tenderness: female (aOR = 3.83; 1.25, 11.77). Predictors of 3-year incident PF grind: lateral patellar osteophytes (aOR = 4.82; 1.69, 13.77). In the age-sex-BMI adjusted model, patellar cartilage was also a predictor. CONCLUSION: We explored potential MRI predictors of prevalent and 3-year incident MTF/LTF knee joint tenderness and PF grind. These findings could guide preemptive strategies aimed at reducing these symptoms in the present and future (3-year incidence).

Control of Line Complications with KiteLock (CLiCK) in the critical care unit: study protocol for a multi-center, cluster-randomized, double-blinded, crossover trial investigating the effect of a novel locking fluid on central line complications in the critical care population.

BACKGROUND: Insertion of a central venous access device (CVAD) allows clinicians to easily access the circulation of a patient to administer life-saving interventions. Due to their invasive nature, CVADs are prone to complications such as bacterial biofilm production and colonization, catheter-related bloodstream infection, occlusion, and catheter-related venous thrombosis. A CVAD is among the most common interventions for patients in the intensive care unit (ICU), exposing this vulnerable population to the risk of nosocomial infection and catheter occlusion. The current standard of care involves the use of normal saline as a catheter locking solution for central venous catheters (CVCs) and peripherally inserted central catheter (PICC) lines, and a citrate lock for hemodialysis catheters. Saline offers little prophylactic measures against catheter complications. Four percent of tetrasodium ethylenediaminetetraacetic acid (EDTA) fluid (marketed as KiteLock Sterile Locking Solution™) is non-antibiotic, possesses antimicrobial, anti-biofilm, and anti-coagulant properties, and is approved by Health Canada as a catheter locking solution. As such, it may be a superior CVAD locking solution than the present standard of care lock in the ICU patient population. METHODS: Our team proposes to fill this knowledge gap by performing a multi-center, cluster-randomized, crossover trial evaluating the impact of 4% tetrasodium EDTA on a primary composite outcome of the incidence rate of central line-associated bloodstream infection (CLABSI), catheter occlusion leading to removal, and use of alteplase to resolve catheter occlusion compared to the standard of care. The study will be performed at five critical care units. DISCUSSION: If successful, the results of this study can serve as evidence for a shift of standard of care practices to include EDTA locking fluid in routine CVAD locking procedures. Completion of this study has the potential to improve CVAD standard of care to become safer for patients, as well as provides an opportunity to decrease strain on healthcare budgets related to treating preventable CVAD complications. Success and subsequent implementation of this intervention in the ICU may also be extrapolated to other patient populations with heavy CVAD use including hemodialysis, oncology, parenteral nutrition, and pediatric patient populations. On a global scale, eradicating biofilm produced by antibiotic-resistant bacteria may serve to lessen the threat of "superbugs" and contribute to international initiatives supporting the termination of antibiotic overuse. TRIAL REGISTRATION: ClinicalTrials.gov NCT04548713, registered on September 9th, 2020.

Reducing the burden of low back pain: results from a new microsimulation model.

BACKGROUND: Low back pain (LBP) causes the highest morbidity burden globally. The purpose of the present study was to project and compare the impact of three strategies for reducing the population health burden of LBP: weight loss, ergonomic interventions, and an exercise program. METHODS: We have developed a microsimulation model of LBP in Canada using a new modeling platform called SimYouLate. The initial population was derived from Cycle 1 (2001) of the Canadian Community Health Survey (CCHS). We modeled an open population 20 years of age and older. Key variables included age, sex, education, body mass index (BMI), type of work, having back problems, pain level in persons with back problems, and exercise participation. The effects of interventions on the risk of LBP were obtained from the CCHS for the effect of BMI, the Global Burden of Disease Study for occupational risks, and a published meta-analysis for the effect of exercise. All interventions lasted from 2021 to 2040. The population health impact of the interventions was calculated as a difference in years lived with disability (YLDs) between the base-case scenario and each intervention scenario, and expressed as YLDs averted per intervention unit or a proportion (%) of total LBP-related YLDs. RESULTS: In the base-case scenario, LBP in 2020 was responsible for 424,900 YLDs in Canada and the amount increased to 460,312 YLDs in 2040. The effects of the interventions were as follows: 27,993 (95% CI 23,373, 32,614) YLDs averted over 20 years per 0.1 unit change in log-transformed BMI (9.5% change in BMI) among individuals who were overweight and those with obesity, 19,416 (16,275, 22,557) YLDs per 1% reduction in the proportion of workers exposed to occupational risks, and 26,058 (22,455, 29,661) YLDs averted per 1% increase in the proportion of eligible patients with back problems participating in an exercise program. CONCLUSIONS: The study provides new data on the relationship between three types of interventions and the resultant reductions in LBP burden in Canada. According to our model, each of the interventions studied could potentially result in a substantial reduction in LBP-related disability.

Arthroscopic Versus Open Ankle Arthrodesis: A 5-Year Follow Up.

BACKGROUND: End-stage ankle arthritis has long been managed surgically with open ankle arthrodesis (OAA). Since the first published report in 1983, arthroscopic ankle arthrodesis (AAA) has been thought to be associated with improved patient-reported outcome measures (PROMs) and fewer complications. The purpose of the present study was to compare the long-term PROMs, major complications, and reoperations for these 2 approaches at up to 15 years of follow-up. METHODS: This longitudinal cohort study included patients at our institution who underwent primary ankle arthrodesis for the treatment of end-stage arthritis. Demographic data and preoperative COFAS (Canadian Orthopaedic Foot and Ankle Society) ankle arthritis type were collected for all patients. PROMs were completed preoperatively, at 6 months, and annually thereafter to 5 years. PROMs were compared at all time points with use of a mixed-effects regression model that adjusted for preoperative variables and scores. Major complications and reoperations at the site of the ankle arthrodesis were also compared. RESULTS: Of 1,294 patients who were screened for inclusion, 351 who had undergone ankle arthrodesis between 2003 and 2019 were eligible for the study. Of those, 223 had undergone AAA and 128 had undergone OAA. The 2 groups were similar preoperatively with respect to demographics, but COFAS Type-4 arthritis was relatively more common in the OAA group and Type-1 arthritis was relatively more common in the AAA group. In addition, the Ankle Osteoarthritis Scale (AOS) score and Ankle Arthritis Score (AAS) were better in the AAA group. In the mixed-effects model analysis, the differences in postoperative outcome scores between the groups were not significant. The risk of revision due to malunion or nonunion was similar in both groups (6% in the AAA group, compared with 4% in the OAA group). Deep infection and wound complications did not occur in the arthroscopic group but occurred in 4% of the patients in the OAA group. CONCLUSIONS: After adjustment for baseline patient characteristics, there were no differences in PROMs between the 2 techniques. Ankle arthrodeses done arthroscopically had a similar revision rate but lower infection rate compared with those done with the open technique. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Home Telemonitoring Technology for Patients With Heart Failure: Cost-Consequence Analysis of a Pilot Study.

BACKGROUND: Heart failure (HF) is a costly health condition and a major public health problem. It is estimated that 2%-3% of the population in developed countries has HF, and the prevalence increases to 8% among patients aged ≥75 years. Home telemonitoring is a form of noninvasive, remote patient monitoring that aims to improve the care and management of patients with chronic HF. Telehealth for Emergency-Community Continuity of Care Connectivity via Home-Telemonitoring (TEC4Home) is a project that implements and evaluates a comprehensive home monitoring protocol designed to support patients with HF as they transition from the emergency department to home. OBJECTIVE: The aim of this study is to assess the cost of using the home monitoring platform (TEC4Home) relative to usual care for patients with HF. METHODS: This study is a cost-consequence analysis of the TEC4Home pilot study. The analysis was conducted from a partial societal perspective, including direct and indirect health care costs. The aim is to assess the costs of the home monitoring platform relative to usual care and track costs related to health care utilization during the 90-day postdischarge period. RESULTS: Economic analysis of the TEC4Home pilot study showed a positive trend in cost savings for patients using TEC4Home. From both the health system perspective (Pre TEC4Home cost per patient: CAD $2924 vs post TEC4Home cost per patient: CAD $1293; P=.01) and partial societal perspective (Pre TEC4Home cost per patient: CAD $2411 vs post TEC4Home cost per patient: CAD $1108; P=.01), we observed a statistically significant cost saving per patient. CONCLUSIONS: In line with the advantages of conducting an economic analysis alongside a feasibility study, the economic analysis of the TEC4Home pilot study facilitated the piloting of patient questionnaires and informed the methodology for a full clinical trial.

Delayed Gadolinium-Enhanced Magnetic Resonance Imaging of Cartilage Values in Hips With Bone Marrow Lesions.

OBJECTIVE: Bone marrow lesions (BMLs) are associated with painful and progressive osteoarthritis (OA). Quantitative magnetic resonance imaging (MRI) has been used to study early cartilage degeneration in knees with BML, but similar work has not been done in hips. The purpose of this study was to compare mean delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) relaxation values (T1Gd) in hips with BML to hips without BML in a population-based study. Reduced T1Gd suggests depleted glycosaminoglycan. Our hypothesis was that mean T1Gd is lower in hips with BML compared to hips without BML. METHODS: Study participants (n = 128) were recruited from a cross-sectional population-based study of people ages 20-49 years with and without hip pain. dGEMRIC and proton density (PD)-weighted MRI scans of 1 hip from each participant were used for this analysis. BMLs were identified from PD-weighted fat-suppressed images. We applied a sampling-weighted linear regression model to determine the association of the presence of BMLs with mean cartilage T1Gd (significance: P < 0.05). The model was adjusted for age, sex, body mass index (BMI), hip pain, cam/pincer deformity, and physical activity. RESULTS: Thirty-two (25%) of the 128 participants had at least 1 BML. Subjects with at least 1 BML, compared to those without, had similar weighted characteristics of age, BMI, physical activity levels, and frequency of hip pain. Mean T1Gd was 75.25 msec lower (95% confidence interval -149.69, -0.81; P = 0.048) (9%) in the BML compared to the no-BML group. CONCLUSION: Our results suggest that hips with BMLs are associated with hip cartilage degeneration early in the OA disease process.

A comparison of three strategies to reduce the burden of osteoarthritis: A population-based microsimulation study.

OBJECTIVES: The purpose of this study was to compare three strategies for reducing population health burden of osteoarthritis (OA): improved pharmacological treatment of OA-related pain, improved access to joint replacement surgery, and prevention of OA by reducing obesity and overweight. METHODS: We applied a validated computer microsimulation model of OA in Canada. The model simulated a Canadian-representative open population aged 20 years and older. Variables in the model included demographics, body mass index, OA diagnosis, OA treatment, mortality, and health-related quality of life. Model parameters were derived from analyses of national surveys, population-based administrative data, a hospital-based cohort study, and the literature. We compared 8 what-if intervention scenarios in terms of disability-adjusted life years (DALYs) relative to base-case, over a wide range of time horizons. RESULTS: Reductions in DALYs depended on the type of intervention, magnitude of the intervention, and the time horizon. Medical interventions (a targeted increase in the use of painkillers) tended to produce effects quickly and were, therefore, most effective over a short time horizon (a decade). Surgical interventions (increased access to joint replacement) were most effective over a medium time horizon (two decades or longer). Preventive interventions required a substantial change in BMI to generate a significant impact, but produced more reduction in DALYs than treatment strategies over a very long time horizon (several decades). CONCLUSIONS: In this population-based modeling study we assessed the potential impact of three different burden reduction strategies in OA. Data generated by our model may help inform the implementation of strategies to reduce the burden of OA in Canada and elsewhere.

A whole-joint, unidimensional, irreversible, and fine-grained MRI knee osteoarthritis severity score, based on cartilage, osteophytes and meniscus (OA-COM).

OBJECTIVE: To develop a whole-joint, unidimensional, irreversible, and fine-grained MRI knee osteoarthritis (OA) severity score, based on cartilage, osteophytes and meniscus (OA-COM), and to predict progression across different severity states using OA-COM as outcome and clinical variables as predictors. METHODS: Population-based knee pain cohort aged 40-79 was assessed at baseline and 7-year follow-up. OA-COM score was defined as the sum of MRI scores for cartilage, osteophytes and menisci, measured at 6, 8 and 6 sites, total score 0-54. To anchor severity levels, we fit cross-sectional logistic models using OA-COM to predict Kellgren-Lawrence (KL) grades in subsets at or one point below each grade. OA-COM threshold scores were selected on sensitivity, specificity, positive and negative predictive value. We developed longitudinal logistic models for OA-COM progression over each threshold over 7 years. Potential predictors included age, sex, BMI, malalignment, physical exam effusion, quadriceps weakness, and crepitus, selected on area under the receiver operating characteristic curve (AUC) and Akaike's Information Criterion (AIC). RESULTS: Optimal OA-COM thresholds were 12, 18, 24 and 30, for KL grades 1 to 4. Significant predictors of progression (depending on threshold) included physical exam effusion, malalignment and female sex, with other selected predictors age, BMI and crepitus. CONCLUSION: OA-COM (0-54 range) is a whole-joint, unidimensional, irreversible, and fine-grained MRI OA severity score reflecting cartilage, osteophytes and menisci. OA-COM scores 12, 18, 24 and 30 are equivalent to KL grades 1 to 4, while offering fine-grained differentiation of states between KL grades, and within pre-radiographic disease (KL = 0) or late-stage disease (KL = 4). In modeling, several clinical variables predicted progression across different states over 7 years.