Person:

Katz, Jeffrey

Bisphosphonates are the primary therapy for postmenopausal and glucocorticoid-induced osteoporosis. Case series suggest a potential link between prolonged use of bisphosphonates and low-energy fracture of subtrochanteric or diaphyseal femur as a consequence of oversuppression of bone resorption. Using health care utilization data, we conducted a propensity score–matched cohort study to examine the incidence rates (IRs) and risk of subtrochanteric or diaphyseal femur fractures among oral bisphosphonate users compared with raloxifene or calcitonin users. A Cox proportional hazards model evaluated the risk of these fractures associated with duration of osteoporosis treatment. A total of 104 subtrochanteric or diaphyseal femur fractures were observed among 33,815 patients. The estimated IR of subtrochanteric or diaphyseal femur fractures per 1000 person-years was 1.46 [95% confidence interval (CI) 1.11–1.88] among the bisphosphonate users and 1.43 (95% CI 1.06–1.89) among raloxifene/calcitonin users. No significant association between bisphosphonate use and subtrochanteric or diaphyseal femur fractures was found [hazard ratio (HR) = 1.03, 95% CI 0.70–1.52] compared with raloxifene/calcitonin. Even with this large study size, we had little precision in estimating the risk of subtrochanteric or diaphyseal femur fractures in patients treated with bisphosphonates for longer than 5 years (HR = 2.02, 95% CI 0.41–10.00). The occurrence of subtrochanteric or diaphyseal femur fracture was rare. There was no evidence of an increased risk of subtrochanteric or diaphyseal femur fractures in bisphosphonate users compared with raloxifene/calcitonin users. However, this study cannot exclude the possibility that long-term bisphosphonate use may increase the risk of these fractures.

Background: Total knee arthroplasty (TKA) is common, effective, and cost-effective. Innovative implants promising reduced long-term failure at increased cost are under continual development. We sought to define the implant cost and performance thresholds under which innovative TKA implants are cost-effective. Methods: We performed a cost-effectiveness analysis using a validated, published computer simulation model of knee osteoarthritis. Model inputs were derived using published literature, Medicare claims, and National Health and Nutrition Examination Survey data. We compared projected TKA implant survival, quality-adjusted life expectancy (QALE), lifetime costs, and cost-effectiveness (incremental cost-effectiveness ratios or ICERs) of standard versus innovative TKA implants. We assumed innovative implants offered 5–70% decreased long-term TKA failure rates at costs 20–400% increased above standard implants. We examined the impact of patient age, comorbidity, and potential increases in short-term failure on innovative implant cost-effectiveness. Results: Implants offering ≥50% decrease in long-term TKA failure at ≤50% increased cost offered ICERs <$100,000 regardless of age or baseline comorbidity. An implant offering a 20% decrease in long-term failure at 50% increased cost provided ICERs <$150,000 per QALY gained only among healthy 50–59-year-olds. Increasing short-term failure, consistent with recent device failures, reduced cost-effectiveness across all groups. Increasing the baseline likelihood of long-term TKA failure among younger, healthier and more active individuals further enhanced innovative implant cost-effectiveness among younger patients. Conclusions: Innovative implants must decrease actual TKA failure, not just radiographic wear, by 50–55% or more over standard implants to be broadly cost-effective. Comorbidity and remaining life span significantly affect innovative implant cost-effectiveness and should be considered in the development, approval and implementation of novel technologies, particularly in orthopedics. Model-based evaluations such as this offer valuable, unique insights for evaluating technological innovation in medical devices.

Introduction: Obesity's association with hand osteoarthritis cannot be fully explained by mechanical loading. We examined the relationship between adipokines and radiographic hand osteoarthritis severity and pain. Methods: In a pilot study of 44 hand osteoarthritis patients (39 women and 5 men), serum adipokine concentrations and hand x-ray Kallman-scores were analyzed using linear regression models. Secondary analyses examined correlates of hand pain. Results: The cohort had a mean age of 63.5 years for women and 72.6 for men; mean (standard deviation) Kallman-scores were 43.3(17.4) for women and 46.2(10.8) for men. Mean body-mass-index was 30 kg/m2 for women and men. Mean leptin concentration was 32.2 ng/ml (women) and 18.5 ng/ml (men); mean adiponectin-total was 7.9 ng/ml (women) and 5.3 ng/ml (men); mean resistin was 7.3 ng/ml (women) and 9.4 ng/ml (men). No association was found between Kallman-scores and adipokine concentrations (R2 = 0.00–0.04 unadjusted analysis, all p-values>0.22). Secondary analyses showed mean visual-analog-scale pain of 4.8(2.4) for women and 6.6(0.9) for men. Leptin, BMI, and history of coronary artery disease were found to be associated with visual-analog-scale scores for chronic hand pain (R2 = 0.36 unadjusted analysis, p-values≤0.04). Conclusion: In this pilot study, we found that adipokine serum concentrations were not associated with hand osteoarthritis radiographic severity; the most important correlates of joint damage were age and disease duration. Leptin serum concentration, BMI, and coronary artery disease were associated with the intensity of chronic hand OA pain.

Background: Routine screening for HIV infection leads to early detection and treatment. We examined patient characteristics associated with repeated screening in a high prevalence country. Methods: We analyzed data from a cohort of 5,229 adults presenting for rapid HIV testing in the outpatient departments of 2 South African hospitals from November 2006 to August 2010. Patients were eligible if they were ≥18 years, reported no previous diagnosis with HIV infection, and not pregnant. Before testing, participants completed a questionnaire including gender, age, HIV testing history, health status, and knowledge about HIV and acquaintances with HIV. Enrollment HIV test results and CD4 counts were abstracted from the medical record. We present prevalence of HIV infection and median CD4 counts by HIV testing history (first-time vs. repeat). We estimated adjusted relative risks (ARR’s) for repeat testing by demographics, health status, and knowledge of HIV and others with HIV in a generalized linear model. Results: Of 4,877 participants with HIV test results available, 26% (N = 1258) were repeat testers. Repeat testers were less likely than first-time testers to be HIV-infected (34% vs. 54%, p<0.001). Median CD4 count was higher among repeat than first-time testers (201/uL vs. 147/uL, p<0.001). Among those HIV negative at enrollment (N = 2,499), repeat testing was more common among those with family or friends living with HIV (ARR 1.50, 95% CI: 1.33–1.68), women (ARR: 1.24, 95% CI: 1.11–1.40), and those self-reporting very good health (ARR: 1.28, 95% CI: 1.12–1.45). Conclusions: In this high prevalence setting, repeat testing was common among those undergoing HIV screening, and was associated with female sex, lower prevalence of HIV infection, and higher CD4 counts at diagnosis.

Introduction: Leptin has been suspected to contribute to the development of osteoarthritis (OA). However, this hypothesis has not been tested in large-scale hand OA cohorts. Our study aimed to determine whether there is a cross-sectional relationship between serum leptin levels and hand OA in a population-based sample of US adults. Method: We used the Third National Health and Nutrition Examination Survey (NHANES III), a national cross-sectional population-based survey, to study the relationship between hand OA and serum leptin concentration. We applied previously established classification criteria for hand OA. Patients with rheumatoid arthritis were excluded. Potential confounders included sex, body mass index, the presence of polyarticular OA, diabetes, and total cholesterol. We estimated unadjusted mean leptin concentration by hand OA status and by all confounders. We further developed a linear regression model to assess mean leptin levels, adjusted for appropriate confounders. Results: Of 2,477 subjects in the NHANES III sample that had a hand examination and did not have rheumatoid arthritis, 1,056 (42.6%) had a leptin measurement and were included in the analysis. Subjects with and without leptin measurement had similar demographic characteristics. We did not find any significant differences in mean serum leptin levels in subjects with symptomatic hand OA (7.38 ng/ml in males (95% confidence interval (CI) = 5.31, 9.46) and 21.55 ng/ml in females (95% CI = 17.08, 26.02)), asymptomatic hand OA (6.69 ng/ml in males (95% CI = 5.19, 8.18) and 17.09 ng/ml in females (95% CI = 15.00, 19.18)), and no hand OA (8.22 ng/ml in males (95% CI = 7.47, 8.97) and 20.77 ng/ml in females (95% CI = 18.01, 23.53)) in the unadjusted analysis. In a multivariable linear regression model that included variables of hand OA status, age, race/ethnicity, and obesity status, we found no statistically significant association between serum leptin and hand OA status. Conclusions: In this cross-sectional study of a large representative US cohort, we did not find any evidence to support the hypothesis that serum leptin is associated with hand OA.

Background: Despite increases in HIV testing, only a fraction of people newly diagnosed with HIV infection enter the care system and initiate antiretroviral therapy (ART) in South Africa. We report on the design and initial enrollment of a randomized trial of a health system navigator intervention to improve linkage to HIV care and TB treatment completion in Durban, South Africa. Methods/Design We employed a multi-site randomized controlled trial design. Patients at 4 outpatient sites were enrolled prior to HIV testing. For all HIV-infected participants, routine TB screening with sputum for mycobacterial smear and culture were collected. HIV-infected participants were randomized to receive the health system navigator intervention or usual care. Participants in the navigator arm underwent a baseline interview using a strengths-based case management approach to assist in identifying barriers to entering care and devising solutions to best cope with perceived barriers. Over 4 months, participants in the navigator arm received scheduled phone and text messages. The primary outcome of the study is linkage and retention in care, assessed 9 months after enrollment. For ART-eligible participants without TB, the primary outcome is 3 months on ART as documented in the medical record; participants co-infected with TB are also eligible to meet the primary outcome of completion of 6 months of TB treatment, as documented by the TB clinic. Secondary outcomes include mortality, receipt of CD4 count and TB test results, and repeat CD4 counts for those not ART-eligible at baseline. We hypothesize that a health system navigator can help identify and positively affect modifiable patient factors, including self-efficacy and social support, that in turn can improve linkage to and retention in HIV and TB care. Discussion We are currently evaluating the clinical impact of a novel health system navigator intervention to promote entry to and retention in HIV and TB care for people newly diagnosed with HIV. The details of this study protocol will inform clinicians, investigators, and policy makers of strategies to best support HIV-infected patients in resource-limited settings. Trial registration Clinicaltrials.gov. unique identifier: NCT01188941.

Background: Structural characteristics of rotator cuff tears are used in surgical decision making. However, data on the association of tear size with patient-reported pain and function are sparse. Purpose: To assess the association of tear size, fatty infiltration, and muscle atrophy with shoulder pain/function in patients with cuff tears undergoing operative and nonoperative treatment. Study Design: Cross-sectional study; Level of evidence, 3. Methods: A total of 67 patients with rotator cuff tears were recruited for this longitudinal cohort study. Patients were determined to have a cuff tear using clinical assessment and blinded magnetic resonance imaging review. The Shoulder Pain and Disability Index (SPADI) was used as a measure of shoulder pain and function. Results: Tear size and thickness were not significantly associated with pain (SPADI pain score, 60.6 [95% CI, 49.8-71.5] for partial-thickness tear; 56.8 [95% CI, 42.8-70.7] for <2 cm full-thickness tear; 60.4 [95% CI, 51.7-69.0] for ≥2 cm full-thickness tear). Tear size and thickness were not associated with function (SPADI disability score, 42.7 [95% CI, 29.8-55.6] for partial-thickness tear; 37.6 [95% CI, 23.9-51.4] for <2 cm full-thickness tear; 45.1 [95% CI, 35.4-54.8] for ≥2 cm full-thickness tear). Fatty infiltration, muscle atrophy, and tendon retraction were also not significantly associated with SPADI pain and disability scores. A Mental Health Index score of <68 as well as age ≥60 years were significantly associated with a higher SPADI pain score. Female sex, increased number of comorbidities, Mental Health Index score of <68, and age <60 years were significantly associated with a higher SPADI disability score. Conclusion: In patients with rotator cuff tears undergoing operative and nonoperative treatment, pain and functional status were not associated with tear size and thickness, fatty infiltration, and muscle atrophy. Conversely, factors unrelated to cuff anatomy such as mental health, comorbidities, age, and sex were associated with pain/function. These findings have clinical implications during surgical decision making and suggest that pain and functional disability in patients with rotator cuff tears is multifactorial and should not solely be attributed to structural characteristics.

Background: Due to difficulties in performing direct measurements as an exposure assessment technique, evidence supporting an association between physical exposures such as neck and shoulder muscle activities and postures and musculoskeletal disorders during computer use is limited. Alternative exposure assessment techniques are needed. Methods: We predicted the median and range of amplitude (90th-10th percentiles) of trapezius muscle activity and the median and range of motion (90th-10th percentiles) of shoulder, head, neck, and torso postures based on two sets of parameters: the distribution of keyboard/mouse/idle activities only (“task-based” predictions), and a comprehensive set of task, questionnaire, workstation, and anthropometric parameters (“expanded model” predictions). We compared the task-based and expanded model predictions based on R2 values, root mean squared (RMS) errors, and relative RMS errors calculated compared to direct measurements. Results: The expanded model predictions of the median and range of amplitude of trapezius muscle activity had consistently better R2 values (range 0.40-0.55 compared to 0.00-0.06), RMS errors (range 2-3%MVC compared to 3-4%MVC), and relative RMS errors (range 10-14%MVC compared to 16-19%MVC) than the task-based predictions. The expanded model predictions of the median and range of amplitude of postures also had consistently better R2 values (range 0.22-0.58 compared to 0.00-0.35), RMS errors (range 2–14 degrees compared to 3–22 degrees), and relative RMS errors (range 9–21 degrees compared to 13–42 degrees) than the task-based predictions. Conclusions: The variation in physical exposures across users performing the same task is large, especially in comparison to the variation across tasks. Thus, expanded model predictions of physical exposures during computer use should be used rather than task-based predictions to improve exposure assessment for future epidemiological studies. Clinically, this finding also indicates that computer users will have differences in their physical exposures even when performing the same tasks.

Background/Objective Physical activity has been shown to be beneficial at improving health in some medical conditions and in preventing injury. Epidemiologic studies suggest that physical activity is one factor associated with a decreased risk for slips and falls in the older (≥65 years) adult population. While the risk of slips and falls is generally lower in younger than in older adults; little is known of the relative contribution of physical activity in preventing slips and falls in younger adults. We examined whether engagement in leisure-time physical activity (LTPA) was protective of slips and falls among a younger/middle-aged (≤50 years old) working population. Methods: 475 workers from 36 limited-service restaurants in six states in the U.S. were recruited to participate in a prospective cohort study of workplace slipping. Information on LTPA was collected at the time of enrollment. Participants reported their slip experience and work hours weekly for up to 12 weeks. We investigated the association between the rate of slipping and the rate of major slipping (i.e., slips that resulted in a fall and/or injury) and LTPA for workers 50 years of age and younger (n = 433, range 18–50 years old) using a multivariable negative binomial generalized estimating equation model. Results: The rate of major slips among workers who engaged in moderate (Adjusted Rate Ratio (RR) = 0.65; 95% Confidence Interval (CI) = [0.18–2.44]) and vigorous (RR = 0.64; 95%CI = [0.18–2.26]) LTPA, while non-significant, were approximately one-third lower than the rate of major slips among less active workers. Conclusion: While not statistically significant, the results suggest a potential association between engagement in moderate and vigorous LTPA and the rate of major slips in younger adults. Additional studies that examine the role of occupational and non-occupational physical activity on the risk of slips, trips and falls among younger and middle aged adults appear warranted.

Background: Evidence-based medicine is an important approach to avoiding care that is unlikely to benefit patients in both the treatment and the diagnostic context. The medical evidence alone may not determine the most appropriate care decision. Patient interests are best served when the advantages and risks of a diagnostic test are viewed through the lens of the patient’s values. That is, the paradigm of evidence-based medicine should be complemented by the paradigm of shared decision making. Analysis Diagnostic testing may offer physiological and psychological benefits. Clinicians should also discuss the potential harms, however, which may be physiological (e.g. radiation or scarring), psychological (e.g. anxiety), and financial (e.g. cost-sharing burdens). All three of these concerns are compounded by the risk of false positives or incidental findings that are not serious, but which require decisions about further testing or treatment. Conclusion: We suggest that patient-centered decision making around diagnostic testing involves a two-step inquiry: Is the test medically appropriate? Does the available evidence documenting short- and long-term risk and benefits support the test for its intended use, given the patient’s characteristics and symptoms?Is the test appropriate for this patient? Has the provider initiated a conversation about tradeoffs that helps the patient evaluate whether the balance of risks and benefits is consonant with the patient’s own values and preferences? Potential benefits and harms to consider include the physiological, the psychological, and the financial.