Factors Associated With Diagnostic Delay in Axial Spondyloarthritis: Impact of Clinical Factors and Social Vulnerability.

OBJECTIVE: Patients with axial spondyloarthritis (axSpA) often experience significant delay between symptom onset and diagnosis for reasons that are incompletely understood. We investigated associations between demographic, medical, and socioeconomic factors and axSpA diagnostic delay. METHODS: We identified patients meeting modified New York criteria for ankylosing spondylitis (AS) or 2009 Assessment of Spondyloarthritis International Society criteria for axSpA in the Mass General Brigham health care system between December 1990 and October 2021. We determined the duration of diagnostic delay, defined as the duration of back pain symptoms reported at diagnosis, as well as disease manifestations and specialty care prior to diagnosis from the electronic health record. We obtained each patient's Social Vulnerability Index (SVI) by mapping their address to the US Centers for Disease Control SVI Atlas. We examined associations among disease manifestations, SVI, and diagnostic delay using ordinal logistic regression. RESULTS: Among 554 patients with axSpA who had a median diagnostic delay of 3.8 years (interquartile range 1.1-10), peripheral arthritis (odds ratio [OR] 0.65, 95% confidence interval [CI] 0.45-0.93) and older age at symptom onset (OR 0.83, 95% CI 0.78-0.88 per five years) were associated with shorter delay. AS at diagnosis (OR 1.85, 95% CI 1.30-2.63), a history of uveitis prior to diagnosis (OR 2.77, 95% CI 1.73-4.52), and higher social vulnerability (defined as national SVI 80th to 99th percentiles; OR 1.99, 95% CI 1.06-3.84) were associated with longer diagnostic delay. CONCLUSION: Older age at back pain onset and peripheral arthritis were associated with shorter delay, whereas uveitis was associated with longer diagnostic delay. Patients with higher socioeconomic vulnerability had longer diagnostic delay independent of clinical factors.

Assessment of Residual Pain and Dissatisfaction in Total Knee Arthroplasty: Methods Matter.

Background: Residual pain after total knee arthroplasty (TKA) refers to knee pain after 3 to 6 months postoperatively. The estimates of the proportion of patients who experience residual pain after TKA vary widely. We hypothesized that the variation may stem from the range of methods used to assess residual pain. We analyzed data from 2 prospective studies to assess the proportion of subjects with residual pain as defined by several commonly used metrics and to examine the association of residual pain defined by each metric with participant dissatisfaction. Methods: We combined participant data from 2 prospective studies of TKA outcomes from subjects recruited between 2011 and 2014. Residual pain was defined using a range of metrics based on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score (0 to 100, in which 100 indicates worst), including the minimal clinically important difference (MCID) and patient acceptable symptom state (PASS). We also examined combinations of MCID and PASS cutoffs. Subjects self-reported dissatisfaction following TKA, and we defined dissatisfied as somewhat or very dissatisfied at 12 months. We calculated the proportion of participants with residual pain, as defined by each metric, who reported dissatisfaction. We examined the association of each metric with dissatisfaction by calculating the sensitivity, specificity, positive predictive value, and Youden index. Results: We analyzed data from 417 subjects with a mean age (and standard deviation) of 66.3 ± 8.3 years. Twenty-six participants (6.2%) were dissatisfied. The proportion of participants defined as having residual pain according to the various metrics ranged from 5.5% to >50%. The composite metric Improvement in WOMAC pain score ≥20 points or final WOMAC pain score ≤25 had the highest positive predictive value for identifying dissatisfied subjects (0.54 [95% confidence interval, 0.35 to 0.71]). No metric had a Youden index of ≥50%. Conclusions: Different metrics provided a wide range of estimates of residual pain following TKA. No estimate was both sensitive and specific for dissatisfaction in patients who underwent TKA, underscoring that measures of residual pain should be defined explicitly in reports of TKA outcomes. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Cost-Effectiveness of Surgical Weight-Loss Interventions for Patients With Knee Osteoarthritis and Class III Obesity.

OBJECTIVE: Class III obesity (body mass index [BMI] ≥40 kg/m2 ) is associated with worse knee pain and total knee replacement (TKR) outcomes. Because bariatric surgery yields sustainable weight loss for individuals with BMI ≥40 kg/m2 , our objective was to establish the value of Roux-en-Y gastric bypass (RYGB) and laparoscopic sleeve gastrectomy (LSG) in conjunction with usual care for knee osteoarthritis (OA) patients with BMI ≥40 kg/m2 . METHODS: We used the Osteoarthritis Policy model to assess long-term clinical benefits, costs, and cost-effectiveness of RYGB and LSG. We derived model inputs for efficacy, costs, and complications associated with these treatments from published data. Primary outcomes included quality-adjusted life-years (QALYs), lifetime costs, and incremental cost-effectiveness ratios (ICERs), all discounted at 3%/year. This analysis was conducted from a health care sector perspective. We performed sensitivity analyses to evaluate uncertainty in input parameters. RESULTS: The usual care + RYGB strategy increased the quality-adjusted life expectancy by 1.35 years and lifetime costs by $7,209, compared to usual care alone (ICER = $5,300/QALY). The usual care + LSG strategy yielded less benefit than usual care + RYGB and was dominated. Relative to usual care alone, both usual care + RYGB and usual care + LSG reduced opioid use from 13% to 4%, and increased TKR usage from 30% to 50% and 41%, respectively. For cohorts with BMI between 38 and 41 kg/m2 , usual care + LSG dominated usual care + RYGB. In the probabilistic sensitivity analysis, at a willingness-to-pay threshold of $50,000/QALY, usual care + RYGB and usual care + LSG were cost-effective in 70% and 30% of iterations, respectively. CONCLUSION: RYGB offers good value among knee OA patients with BMI ≥40 kg/m2 , while LSG may provide good value among those with BMI between 35 and 41 kg/m2 .

Cost-Effectiveness of Weight-Loss Interventions Prior to Total Knee Replacement for Patients With Class III Obesity.

OBJECTIVE: Class III obesity (body mass index >40 kg/m2 ) is associated with higher complications following total knee replacement (TKR), and weight loss is recommended. We aimed to establish the cost-effectiveness of Roux-en-Y gastric bypass (RYGB), laparoscopic sleeve gastrectomy (LSG), and lifestyle nonsurgical weight loss (LNSWL) interventions in knee osteoarthritis patients with class III obesity considering TKR. METHODS: Using the Osteoarthritis Policy model and data from published literature to derive model inputs for RYGB, LSG, LNSWL, and TKR, we assessed the long-term clinical benefits, costs, and cost-effectiveness of weight-loss interventions for patients with class III obesity considering TKR. We assessed the following strategies with a health care sector perspective: 1) no weight loss/no TKR, 2) immediate TKR, 3) LNSWL, 4) LSG, and 5) RYGB. Each weight-loss strategy was followed by annual TKR reevaluation. Primary outcomes were cost, quality-adjusted life expectancy (QALE), and incremental cost-effectiveness ratios (ICERs), discounted at 3% per year. We conducted deterministic and probabilistic sensitivity analyses to examine the robustness of conclusions to input uncertainty. RESULTS: LSG increased QALE by 1.64 quality-adjusted life-years (QALYs) and lifetime medical costs by $17,347 compared to no intervention, leading to an ICER of $10,600/QALY. RYGB increased QALE by 0.22 and costs by $4,607 beyond LSG, resulting in an ICER of $20,500/QALY. Relative to immediate TKR, LSG and RYGB delayed and decreased TKR utilization. In the probabilistic sensitivity analysis, RYGB was cost-effective in 67% of iterations at a willingness-to-pay threshold of $50,000/QALY. CONCLUSION: For patients with class III obesity considering TKR, RYGB provides good value while immediate TKR without weight loss is not economically efficient.

Diabetes Remission Status During Seven-year Follow-up of the Longitudinal Assessment of Bariatric Surgery Study.

CONTEXT: Few studies have examined the clinical characteristics that predict durable, long-term diabetes remission after bariatric surgery. OBJECTIVE: To compare diabetes prevalence and remission rates during 7-year follow-up after Roux-en-Y gastric bypass (RYGB) and laparoscopic gastric banding (LAGB). DESIGN: An observational cohort of adults with severe obesity recruited between 2006 and 2009 who completed annual research assessments for up to 7 years after RYGB or LAGB. SETTING: Ten US hospitals. PARTICIPANTS: A total sample of 2256 participants, 827 with known diabetes status at both baseline and at least 1 follow-up visit. INTERVENTIONS: Roux-en-Y gastric bypass or LAGB. MAIN OUTCOME MEASURES: Diabetes rates and associations of patient characteristics with remission status. RESULTS: Diabetes remission occurred in 57% (46% complete, 11% partial) after RYGB and 22.5% (16.9% complete, 5.6% partial) after LAGB. Following both procedures, remission was greater in younger participants and those with shorter diabetes duration, higher C-peptide levels, higher homeostatic model assessment of ß-cell function (HOMA %B), and lower insulin usage at baseline, and with greater postsurgical weight loss. After LAGB, reduced HOMA insulin resistance (IR) was associated with a greater likelihood of diabetes remission, whereas increased HOMA-%B predicted remission after RYGB. Controlling for weight lost, diabetes remission remained nearly 4-fold higher compared with LAGB. CONCLUSIONS: Durable, long-term diabetes remission following bariatric surgery is more likely when performed soon after diagnosis when diabetes medication burden is low and beta-cell function is preserved. A greater weight-independent likelihood of diabetes remission after RYGB than LAGB suggests mechanisms beyond weight loss contribute to improved beta-cell function after RYGB.Trial Registration clinicaltrials.gov Identifier: NCT00465829.

Willingness of older adults to participate in a randomized trial of conservative therapies for knee pain: A prospective preference assessment.

BACKGROUND: In preparation for a trial of physical therapy (PT) for patients with degenerative meniscal tear and knee osteoarthritis, we conducted a prospective preference assessment -- a methodology for estimating the proportion of eligible subjects who would participate in a hypothetical randomized trial. METHODS: We identified patients seeking care from the practices of five orthopedic surgeons. Patients completed a survey asking about their willingness to participate in a hypothetical trial, their treatment preferences, their knee pain, and demographic variables. RESULTS: We approached 201 eligible patients, of whom 67% (95% confidence interval [CI] 60%, 73%) completed questionnaires. Of these, 24% (95% CI 17%, 31%) were definitely and 39% (95% CI 31%, 47%) were probably willing to participate in the trial. Thirty-three percent (95% CI 23%, 43%) of subjects with no treatment preference were definitely willing to participate as compared to 9% (95% CI 1%, 17%) with treatment preference (p = .001). Patients with higher educational attainment also stated a greater willingness to participate than those with less education (p = .06). In multivariable logistic regression analysis, those with no treatment preferences had greater adjusted odds of stating they would definitely participate than those with a defined treatment preference (OR 5.2, 95% CI 1.7, 16.2), while subjects with an associate's degree or greater were more likely to state they would definitely participate than those with less education (OR 3.9, 95% CI 1.1, 14.1). CONCLUSION: In this prospective preference assessment, 63% (95% CI 55%, 71%) of subjects with degenerative meniscal tear expressed willingness to participate in a trial of PT modalities. Individuals with no treatment preferences were more likely to state they would participate than were those with higher education. This methodology can help investigators estimate recruitment rates, anticipate generalizability of the trial sample and create strategies to facilitate enrollment.

Financial Incentives and Health Coaching to Improve Physical Activity Following Total Knee Replacement: A Randomized Controlled Trial.

OBJECTIVE: Most persons who undergo total knee replacement (TKR) do not increase their physical activity following surgery. We assessed whether financial incentives and health coaching would improve physical activity in persons undergoing TKR. METHODS: We designed a factorial randomized controlled trial among persons undergoing TKR for osteoarthritis. Subjects underwent normal perioperative procedures, including postoperative physical therapy, and were assigned to 1 of 4 arms: attention control, telephonic health coaching (THC), financial incentives (FI), or THC + FI. We objectively measured step counts and minutes of physical activity using a commercial accelerometer (Fitbit Zip) and compared the changes from pre-TKR to 6 months post-TKR across the 4 study arms. RESULTS: Of the 202 randomized subjects, 150 (74%) provided both pre-TKR and 6 months post-TKR accelerometer data. Among completers, the mean ± SE daily step count at 6 months ranged from 5,619 ± 381 in the THC arm to 7,152 ± 407 in the THC + FI arm (adjusting for baseline values). Daily step count 6 months post-TKR increased by 680 (95% confidence interval [95% CI] -94, 1,454) in the control arm, 274 (95% CI -473, 1,021) in the THC arm, 826 (95% CI 89, 1,563) in the FI arm, and 1,808 (95% CI 1,010, 2,606) in the THC + FI arm. Weekly physical activity increased by mean ± SE 14 ± 10, 14 ± 10, 16 ± 10, and 39 ± 11 minutes in the control, THC, FI, and THC + FI arms, respectively. CONCLUSION: A dual THC + FI intervention led to substantial improvements in step count and physical activity following TKR.

Type 2 Diabetes Remission Rates After Laparoscopic Gastric Bypass and Gastric Banding: Results of the Longitudinal Assessment of Bariatric Surgery Study.

OBJECTIVE: The goals of this study were to determine baseline and postbariatric surgical characteristics associated with type 2 diabetes remission and if, after controlling for differences in weight loss, diabetes remission was greater after Roux-en-Y gastric bypass (RYGBP) than laparoscopic gastric banding (LAGB). RESEARCH DESIGN AND METHODS: An observational cohort of obese participants was studied using generalized linear mixed models to examine the associations of bariatric surgery type and diabetes remission rates for up to 3 years. Of 2,458 obese participants enrolled, 1,868 (76%) had complete data to assess diabetes status at both baseline and at least one follow-up visit. Of these, 627 participants (34%) were classified with diabetes: 466 underwent RYGBP and 140 underwent LAGB. RESULTS: After 3 years, 68.7% of RYGBP and 30.2% of LAGB participants were in diabetes remission. Baseline factors associated with diabetes remission included a lower weight for LAGB, greater fasting C-peptide, lower leptin-to-fat mass ratio for RYGBP, and a lower hemoglobin A1c without need for insulin for both procedures. After both procedures, greater postsurgical weight loss was associated with remission. However, even after controlling for differences in amount of weight lost, relative diabetes remission rates remained nearly twofold higher after RYGBP than LAGB. CONCLUSIONS: Diabetes remission up to 3 years after RYGBP and LAGB was proportionally higher with increasing postsurgical weight loss. However, the nearly twofold greater weight loss-adjusted likelihood of diabetes remission in subjects undergoing RYGBP than LAGB suggests unique mechanisms contributing to improved glucose metabolism beyond weight loss after RYGBP.

Medication Use by Race and Ethnicity in Women Transitioning Through the Menopause: A Study of Women's Health Across the Nation Drug Epidemiology Study.

BACKGROUND: Medication utilization and costs increased over the last decade, but the effects of race/ethnicity have never been well studied in longitudinal data. We analyzed reports of prescription medication use to (1) identify trajectories of use and (2) determine predictors associated with a large increase in use. Specifically, variations in medication use by race/ethnicity were examined. METHODS: We analyzed the Study of Women's Health Across the Nation cohort with a median of 14 years of follow-up. Group-based trajectory models helped distinguish women with a low use of medications versus those with heavy use. Logistic regression was used to estimate the odds ratio (OR) for each racial/ethnic group associated with heavy use, controlling for potential baseline confounders. RESULTS: The 2,798 women sampled had a mean age of 46 years at baseline and the median number of medications at baseline was 2, increasing to 4 over the follow-up period. Trajectory models identified that 16% of participants demonstrated heavy use of medications, from a median of 5 at baseline to 10 medications at final follow-up. Regression models controlling for age, obesity, number of comorbid conditions, and pain found that Hispanic (OR = 0.085, 95% confidence interval [CI]: 0.037-0.20), Chinese (OR = 0.32, 95% CI: 0.16-0.63), Japanese (OR = 0.33, 95% CI: 0.17-0.64), and Black (OR = 0.79, 95% CI: 0.57-1.11) women had lower odds for heavy use compared with White women. CONCLUSIONS: Longitudinal medication use among women in Study of Women's Health Across the Nation (SWAN) differed by race/ethnicity with non-White women having a lower odds of heavy use.

Metabolic syndrome prevalence and associations in a bariatric surgery cohort from the Longitudinal Assessment of Bariatric Surgery-2 study.

BACKGROUND: Metabolic syndrome is associated with higher risk for cardiovascular disease, sleep apnea, and nonalcoholic steatohepatitis, all common conditions in patients referred for bariatric surgery, and it may predict early postoperative complications. The objective of this study was to determine the prevalence of metabolic syndrome, defined using updated National Cholesterol Education Program criteria, in adults undergoing bariatric surgery and compare the prevalence of baseline co-morbid conditions and select operative and 30-day postoperative outcomes by metabolic syndrome status. METHODS: Complete metabolic syndrome data were available for 2275 of 2458 participants enrolled in the Longitudinal Assessment of Bariatric Surgery-2 (LABS-2), an observational cohort study designed to evaluate long-term safety and efficacy of bariatric surgery in obese adults. RESULTS: The prevalence of metabolic syndrome was 79.9%. Compared to those without metabolic syndrome, those with metabolic syndrome were significantly more likely to be men, to have a higher prevalence of diabetes and prior cardiac events, to have enlarged livers and higher median levels of liver enzymes, a history of sleep apnea, and a longer length of stay after surgery following laparoscopic Roux-en-Y gastric bypass (RYGB) and gastric sleeves but not open RYGB or laparoscopic adjustable gastric banding. Metabolic syndrome status was not significantly related to duration of surgery or rates of composite end points of intraoperative events and 30-day major adverse surgical outcomes. CONCLUSIONS: Nearly four in five participants undergoing bariatric surgery presented with metabolic syndrome. Establishing a diagnosis of metabolic syndrome in bariatric surgery patients may identify a high-risk patient profile, but does not in itself confer a higher risk for short-term adverse postsurgery outcomes.

Five-year follow-up of patients treated for coronary artery disease in the face of an increasing burden of co-morbidity and disease complexity (from the NHLBI Dynamic Registry).

Management of coronary artery disease (CAD) has evolved over the past decade, but there are few prospective studies evaluating long-term outcomes in a real-world setting of evolving technical approaches and secondary prevention. The aim of this study was to determine how the mortality and morbidity of CAD has changed in patients who have undergone percutaneous coronary intervention (PCI), in the setting of co-morbidities and evolving management. The National Heart, Lung, and Blood Institute Dynamic Registry was a cohort study of patients undergoing PCI at various time points. Cohorts were enrolled in 1999 (cohort 2, n = 2,105), 2004 (cohort 4, n = 2,112), and 2006 (cohort 5, n = 2,176), and each was followed out to 5 years. Primary outcomes were death, myocardial infarction (MI), coronary artery bypass grafting, repeat PCI, and repeat revascularization. Secondary outcomes were PCI for new obstructive lesions at 5 years, 5-year rates of death and MI stratified by the severity of coronary artery and co-morbid disease. Over time, patients were more likely to have multiple co-morbidities and more severe CAD. Despite greater disease severity, there was no significant difference in death (16.5% vs 17.6%, adjusted hazard ratio [HR] 0.89, 95% confidence interval [CI] 0.74 to 1.08), MI (11.0% vs 10.6%, adjusted HR 0.87, 95% CI 0.70 to 1.08), or repeat PCI (20.4% vs 22.2%, adjusted HR 0.98, 95% CI 0.85 to 1.17) at 5-year follow-up, but there was a significant decrease in coronary artery bypass grafting (9.1% vs 4.3%, adjusted HR 0.44, 95% CI 0.32 to 0.59). Patients with 5 co-morbidities had a 40% to 60% death rate at 5 years. There was a modestly high rate of repeat PCI for new lesions, indicating a potential failure of secondary prevention for this population in the face of increasing co-morbidity. Overall 5-year rates of death, MI, repeat PCI, and repeat PCI for new lesions did not change significantly in the context of increased co-morbidities and complex disease.

Psychopathology before surgery in the longitudinal assessment of bariatric surgery-3 (LABS-3) psychosocial study.

BACKGROUND: Current and previous psychopathology in bariatric surgery candidates is believed to be common. Accurate prevalence estimates, however, are difficult to obtain given that bariatric surgery candidates often wish to appear psychiatrically healthy when undergoing psychiatric evaluation for approval for surgery. Also, structured diagnostic assessments have been infrequently used. METHODS: The present report concerned 199 patients enrolled in the longitudinal assessment of bariatric surgery study, who also participated in the longitudinal assessment of bariatric surgery-3 psychopathology substudy. The setting was 3 university hospitals, 1 private not-for-profit research institute, and 1 community hospital. All the patients were interviewed independently of the usual preoperative psychosocial evaluation process. The patients were explicitly informed that the data would not be shared with the surgical team unless certain high-risk behaviors, such as suicidality, that could lead to adverse perioperative outcomes were reported. RESULTS: Most of the patients were women (82.9%) and white (nonwhite 7.6%, Hispanic 5.0%). The median age was 46.0 years, and the median body mass index was 44.9 kg/m2. Of the 199 patients, 33.7% had ≥1 current Axis I disorder, and 68.8% had ≥1 lifetime Axis I disorder. Also, 38.7% had a lifetime history of a major depressive disorder, and 33.2% had a lifetime diagnosis of alcohol abuse or dependence. All these rates were much greater than the population-based prevalence rates obtained for this age group in the National Comorbidity Survey-Replication Study. Also, 13.1% had a lifetime diagnosis and 10.1% had a current diagnosis of a binge eating disorder. CONCLUSION: The current and lifetime rates of psychopathology are high in bariatric surgery candidates, and the lifetime rates of affective disorder and alcohol use disorders are particularly prominent. Finally, binge eating disorder is present in approximately 1 in 10 bariatric surgery candidates.

Cost of medical services in older patients with heart failure: those receiving enhanced monitoring using a computer-based telephonic monitoring system compared with those in usual care: the Heart Failure Home Care trial.

BACKGROUND: Prior studies suggest that disease management programs may be effective in improving clinical and economic outcomes in patients with heart failure. Whether these types of programs can lower health care cost and be adapted to the primary care setting is unknown. This study was designed to assess the impact of a home-based disease management program, the Alere DayLink HF Monitoring System (HFMS), on the clinical and economic outcomes of Medicare beneficiaries recently hospitalized for heart failure who received the care from a community-based primary care practitioner. METHODS AND RESULTS: The Heart Failure Home Care trial was a multicenter, randomized, controlled trial of sophisticated, monitoring of heart failure patients with an interactive program versus standard heart failure care with enhanced patient education and follow-up (SC) in Medicare-eligible patients. The study endpoints included cardiovascular death or rehospitalization for heart failure, length of hospital stay, total patient cost, and cost to Medicare at 6 months of enrollment. A total of 315 patients age ≥ 65 years old were randomized: 160 to the HFMS and 155 to SC. There were no significant statistical differences between the groups in regards to 6-month cardiac mortality, rehospitalizations for heart failure, or length of hospital stay. Of those, 304 patients had their Medicare data available. The information from the Medicare claims data was used to determine the cost. Information from the trial was used to determine costs of out-patient drugs and the interventions. The 6-month mean Medicare costs were estimated to be $17,837 and $13,886 for the HFMS and the SC groups, respectively. We found that overall medical costs of medicare patients were significantly higher for patients who were randomized to the HFMS arm than they were for the patients randomized to the SC arm. CONCLUSIONS: Our study results suggest that enhanced patient education and follow-up is as successful as a sophisticated home monitoring device with an interactive program and less costly in patients who are elderly and receive the care from a community-based primary care practitioner.