Person: Losina, Elena
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Losina
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Elena
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Losina, Elena
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Publication Development and feasibility of a personalized, interactive risk calculator for knee osteoarthritis(BioMed Central, 2015) Losina, Elena; Klara, Kristina; Michl, Griffin L.; Collins, Jamie; Katz, JeffreyBackground: The incidence of knee osteoarthritis (OA) is rising. While several risk factors have been associated with the development of knee OA, this information is not readily accessible to those at risk for osteoarthritis. Risk calculators have been developed for several prevalent chronic conditions but not for OA. Using published evidence on established risk factors, we developed an interactive, personalized knee OA risk calculator (OA Risk C) and conducted a pilot study to evaluate its acceptability and feasibility. Methods: We used the Osteoarthritis Policy (OAPol) Model, a validated, state-transition simulation of the natural history and management of OA, to generate data for OA Risk C. Risk estimates for calculator users were based on a set of demographic and clinical factors (age, sex, race/ethnicity, obesity) and select risk factors (family history of knee OA, occupational exposure, and history of knee injury). OA Risk C presents personalized risk of knee OA in several ways to maximize understanding among a wide range of users. We conducted a study of 45 subjects in a primary care setting to establish the feasibility and acceptability of the OA risk calculator. Pilot study participants were asked several questions regarding ease of use, clarity of presentation, and clarity of the graphical representation of their risk. These questions used a five-level agreement scale ranging from strongly disagree to strongly agree. Results: OA Risk C depicts information about users’ risk of symptomatic knee OA in 5 year intervals. Study participants estimated their lifetime risk at 38 %, while their actual lifetime risk, as estimated by OA Risk C, was 25 %. Eighty-four percent of pilot study participants reported that OA Risk C was easy to understand, and 89 % agreed that the graphs depicting their risk were clear and comprehensible. Conclusions: We have developed a personalized, computer-based OA risk calculator that is easy to use. OA Risk C may be utilized to estimate individuals’ knee OA risk and to deliver educational and behavioral interventions focused on osteoarthritis risk reduction.Publication The cost‐effectiveness of HIV pre‐exposure prophylaxis in men who have sex with men and transgender women at high risk of HIV infection in Brazil(John Wiley and Sons Inc., 2018) Luz, Paula M; Osher, Benjamin; Grinsztejn, Beatriz; Maclean, Rachel L; Losina, Elena; Stern, Madeline E; Struchiner, Claudio J; Parker, Robert; Freedberg, Kenneth; Mesquita, Fabio; Walensky, Rochelle; Veloso, Valdilea G; Paltiel, A DavidAbstract Introduction: Men who have sex with men (MSM) and transgender women (TGW) in Brazil experience high rates of HIV infection. We examined the clinical and economic outcomes of implementing a pre‐exposure prophylaxis (PrEP) programme in these populations. Methods: We used the Cost‐Effectiveness of Preventing AIDS Complications (CEPAC)‐International model of HIV prevention and treatment to evaluate two strategies: the current standard of care (SOC) in Brazil, including universal ART access (No PrEP strategy); and the current SOC plus daily tenofovir/emtracitabine PrEP (PrEP strategy) until age 50. Mean age (31 years, SD 8.4 years), age‐stratified annual HIV incidence (age ≤ 40 years: 4.3/100 PY; age > 40 years: 1.0/100 PY), PrEP effectiveness (43% HIV incidence reduction) and PrEP drug costs ($23/month) were from Brazil‐based sources. The analysis focused on direct medical costs of HIV care. We measured the comparative value of PrEP in 2015 United States dollars (USD) per year of life saved (YLS). Willingness‐to‐pay threshold was based on Brazil's annual per capita gross domestic product (GDP; 2015: $8540 USD). Results: Lifetime HIV infection risk among high‐risk MSM and TGW was 50.5% with No PrEP and decreased to 40.1% with PrEP. PrEP increased per‐person undiscounted (discounted) life expectancy from 36.8 (20.7) years to 41.0 (22.4) years and lifetime discounted HIV‐related medical costs from $4100 to $8420, which led to an incremental cost‐effectiveness ratio (ICER) of $2530/YLS. PrEP remained cost‐effective (<1x GDP) under plausible variation in key parameters, including PrEP effectiveness and cost, initial cohort age and HIV testing frequency on/off PrEP. Conclusion: Daily tenofovir/emtracitabine PrEP among MSM and TGW at high risk of HIV infection in Brazil would increase life expectancy and be highly cost‐effective.Publication Factors influencing the enrollment in randomized controlled trials in orthopedics(Elsevier, 2017) Lim, Christopher T.; Roberts, Heather J.; Collins, Jamie; Losina, Elena; Katz, JeffreyBackground: Low enrollment rates are a threat to the external validity of clinical trials. The purpose of this study was to identify factors associated with lower enrollment rates in randomized controlled trials (RCTs) involving orthopedic procedures. Methods: We performed a search in PubMed/MEDLINE for RCTs that involved any orthopedic surgical procedure, compared different intraoperative interventions, were published in English in a peer-reviewed journal between 2003 and 2014, and reported the numbers of both enrolled and eligible subjects. The primary outcome was the enrollment rate, defined as the number of enrolled subjects divided by the number of eligible subjects. We used a meta-regression to identify factors associated with lower enrollment rates. Results: The combined estimate of enrollment rate across all 393 studies meeting inclusion criteria was 90% (95% CI: 89–92%). Trials in North America had significantly lower enrollment rates compared to trials in the rest of the world (80% vs. 92%, p < 0.0001). Trials comparing operative and non-operative treatments had significantly lower enrollment rates than trials comparing two different operative interventions (80% vs. 91%, p < 0.0001). Among trials comparing operative and non-operative interventions, there was a marked difference in enrollment rate by region: 49% in North America and 86% elsewhere (p < 0.0001). Conclusions: RCTs investigating orthopedic procedures have variable enrollment rates depending on their location and the difference between the interventions being studied. North American trials that compare operative and non-operative interventions have the lowest enrollment rates. Investigators planning RCTs would be well advised to consider these data in planning recruitment efforts.Publication Willingness of older adults to participate in a randomized trial of conservative therapies for knee pain: A prospective preference assessment(Elsevier, 2018) Kerman, Hannah M.; Deshpande, Bhushan; Selzer, Faith; Losina, Elena; Katz, JeffreyBackground: 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.Publication Clinical Benefits and Cost-Effectiveness of Laboratory Monitoring Strategies to Guide Antiretroviral Treatment Switching in India(Mary Ann Liebert, Inc., 2018) Freedberg, Kenneth; Kumarasamy, Nagalingeswaran; Borre, Ethan D.; Ross, Eric L.; Mayer, Kenneth; Losina, Elena; Swaminathan, Soumya; Flanigan, Timothy P.; Walensky, RochelleAbstract Current Indian guidelines recommend twice-annual CD4 testing to monitor first-line antiretroviral therapy (ART), with a plasma HIV RNA test to confirm failure if CD4 declines, which would prompt a switch to second-line ART. We used a mathematical model to assess the clinical benefits and cost-effectiveness of alternative laboratory monitoring strategies in India. We simulated a cohort of HIV-infected patients initiating first-line ART and compared 11 strategies with combinations of CD4 and HIV RNA testing at varying frequencies. We included adaptive strategies that reduce the frequency of tests after 1 year from 6 to 12 months for virologically suppressed patients. We projected life expectancy, time on failed first-line ART, cumulative 10-year HIV transmissions, lifetime cost (2014 US dollars), and incremental cost-effectiveness ratios (ICERs). We defined strategies as cost-effective if their ICER was <1 × the Indian per capita gross domestic product (GDP, $1,600). We found that the current Indian guidelines resulted in a per person life expectancy (from mean age 37) of 150.2 months and a per person cost of $2,680. Adding annual HIV RNA testing increased survival by ∼8 months; adaptive strategies were less expensive than similar nonadaptive strategies with similar life expectancy. The most effective strategy with an ICER <1 × GDP was the adaptive HIV RNA strategy (ICER $840/year). Cumulative 10-year transmissions decreased from 27.2/1,000 person-years with standard-of-care to 20.9/1,000 person-years with adaptive HIV RNA testing. In India, routine HIV RNA monitoring of patients on first-line ART would increase life expectancy, decrease transmissions, be cost-effective, and should be implemented.Publication Counselor- Versus Provider-Based HIV Screening in the Emergency Department: Results From the Universal Screening for HIV Infection in the Emergency Room (USHER) Randomized Controlled Trial(Elsevier BV, 2011-07) Walensky, Rochelle; Reichmann, William M.; Arbelaez, Christian; Wright, Elizabeth; Katz, Jeffrey; Seage, George; Safren, Steven A.; Hare, Anna Q.; Novais, Anna; Losina, ElenaObjective We compare rates of rapid HIV testing, test offer, and acceptance in an urban emergency department (ED) when conducted by dedicated HIV counselors versus current members of the ED staff. Methods The Universal Screening for HIV Infection in the Emergency Room [USHER] trial is a prospective randomized controlled trial that implemented an HIV screening program in the ED of an urban tertiary medical center. ED patients were screened and consented for trial enrollment by an USHER research assistant. Eligible subjects were randomized to rapid HIV testing (oral OraQuick) offered by a dedicated counselor (counselor arm) or by an ED provider (provider arm). In the counselor arm, counselors—without other clinical responsibilities—assumed nearly all testing-related activities (consent, counseling, delivery of test results). In the provider arm, trained ED emergency service assistants (nursing assistants) consented and tested the participant in the context of other ED-related responsibilities. In this arm, ED house officers, physician assistants, or attending physicians provided HIV test results to trial participants. Outcome measures were rates of HIV testing and test offer among individuals consenting for study participation. Among individuals offered the test, test acceptance was also measured. Results From February 2007 through July 2008, 8,187 eligible patients were approached in the ED, and 4,855 (59%) consented and were randomized to trial participation. The mean age was 37 years, 65% were women, and 42% were white. The overall testing rate favored the counselor arm (57% versus 27%; P < .001); 80% (1,959/2,446) of subjects in the counselor arm were offered an HIV test compared with 36% (861/2,409) in the provider arm (P < .001). HIV test acceptance was slightly higher in the provider arm (counselor arm 71% versus provider arm 75%; P = .025). Conclusion Routine rapid HIV testing in the ED was accomplished more frequently by dedicated HIV counselors than by ED staff in the course of routine clinical work. Without dedicated staff, HIV testing in this setting may not be truly routine.Publication Does Modality of Survey Administration Impact Data Quality: Audio Computer Assisted Self Interview (ACASI) Versus Self-Administered Pen and Paper?(Public Library of Science (PLoS), 2010-01-15) Reichmann, William M.; Losina, Elena; Seage, George; Arbelaez, Christian; Safren, Steven A.; Katz, Jeffrey; Hetland, Adam; Walensky, RochelleBackground In the context of a randomized controlled trial (RCT) on HIV testing in the emergency department (ED) setting, we evaluated preferences for survey modality and data quality arising from each modality. Methods Enrolled participants were offered the choice of answering a survey via audio computer assisted self-interview (ACASI) or pen and paper self-administered questionnaire (SAQ). We evaluated factors influencing choice of survey modality. We defined unusable data for a particular survey domain as answering fewer than 75% of the questions in the domain. We then compared ACASI and SAQ with respect to unusable data for domains that address sensitive topics. Results Of 758 enrolled ED patients, 218 (29%) chose ACASI, 343 chose SAQ (45%) and 197 (26%) opted not to complete either. Results of the log-binomial regression indicated that older (RR = 1.08 per decade) and less educated participants (RR = 1.25) were more likely to choose SAQ over ACASI. ACASI yielded substantially less unusable data than SAQ. Conclusions In the ED setting there may be a tradeoff between increased participation with SAQ versus better data quality with ACASI. Future studies of novel approaches to maximize the use of ACASI in the ED setting are needed.Publication Implementation of a workplace intervention using financial rewards to promote adherence to physical activity guidelines: a feasibility study(BioMed Central, 2017) Losina, Elena; Smith, Savannah R.; Usiskin, Ilana M.; Klara, Kristina M.; Michl, Griffin L.; Deshpande, Bhushan; Yang, Heidi Y.; Smith, Karen C.; Collins, Jamie; Katz, JeffreyBackground: We designed and implemented the Brigham and Women’s Wellness Initiative (B-Well), a single-arm study to examine the feasibility of a workplace program that used individual and team-based financial incentives to increase physical activity among sedentary hospital employees. Methods: We enrolled sedentary, non-clinician employees of a tertiary medical center who self-reported low physical activity. Eligible participants formed or joined teams of three members and wore Fitbit Flex activity monitors for two pre-intervention weeks followed by 24 weeks during which they could earn monetary rewards. Participants were rewarded for increasing their moderate-to-vigorous physical activity (MVPA) by 10% from the previous week or for meeting the Centers for Disease Control and Prevention (CDC) physical activity guidelines (150 min of MVPA per week). Our primary outcome was the proportion of participants meeting weekly MVPA goals and CDC physical activity guidelines. Secondary outcomes included Fitbit-wear adherence and factors associated with meeting CDC guidelines more consistently. Results: B-Well included 292 hospital employees. Participants had a mean age of 38 years (SD 11), 83% were female, 38% were obese, and 62% were non-Hispanic White. Sixty-three percent of participants wore the Fitbit ≥4 days per week for ≥20 weeks. Two-thirds were satisfied with the B-Well program, with 79% indicating that they would participate again. Eighty-six percent met either their personal weekly goal or CDC physical activity guidelines for at least 6 out of 24 weeks, and 52% met their goals or CDC physical activity guidelines for at least 12 weeks. African Americans, non-obese subjects, and those with lower impulsivity scores reached CDC guidelines more consistently. Conclusions: Our data suggest that a financial incentives-based workplace wellness program can increase MVPA among sedentary employees. These results should be reproduced in a randomized controlled trial. Trial registration Clinicaltrials.gov, NCT02850094. Registered July 27, 2016 [retrospectively registered].Publication Prevalence and risk factors for periprosthetic fracture in older recipients of total hip replacement: a cohort study(BioMed Central, 2014) Katz, Jeffrey; Wright, Elizabeth; Polaris, Julian JZ; Harris, Mitchel; Losina, ElenaBackground: The growing utilization of total joint replacement will increase the frequency of its complications, including periprosthetic fracture. The prevalence and risk factors of periprosthetic fracture require further study, particularly over the course of long-term follow-up. The objective of this study was to estimate the prevalence and risk factors for periprosthetic fractures occurring in recipients of total hip replacement. Methods: We identified Medicare beneficiaries who had elective primary total hip replacement (THR) for non-fracture diagnoses between July 1995 and June 1996. We followed them using Medicare Part A claims data through 2008. We used ICD-9 codes to identify periprosthetic femoral fractures occurring from 2006–2008. We used the incidence density method to calculate the annual incidence of these fractures and Cox proportional hazards models to identify risk factors for periprosthetic fracture. We also calculated the risk of hospitalization over the subsequent year. Results: Of 58,521 Medicare beneficiaries who had elective primary THR between July 1995 and June 1996, 32,463 (55%) survived until January 2006. Of these, 215 (0.7%) developed a periprosthetic femoral fracture between 2006 and 2008. The annual incidence of periprosthetic fracture among these individuals was 26 per 10,000 person-years. In the Cox model, a greater risk of periprosthetic fracture was associated with having had a total knee replacement (HR 1.82, 95% CI 1.30, 2.55) or a revision total hip replacement (HR1.40, 95% CI 0.95, 2.07) between the primary THR and 2006. Compared to those without fractures, THR recipients who sustained periprosthetic femoral fracture had three-fold higher risk of hospitalization in the subsequent year (89% vs. 27%, p < 0.0001). Conclusion: A decade after primary THR, periprosthetic fractures occur annually in 26 per 10,000 persons and are especially frequent in those with prior total knee or revision total hip replacements.Publication A randomized trial to optimize HIV/TB care in South Africa: design of the Sizanani trial(BioMed Central, 2013) Bassett, Ingrid; Giddy, Janet; Chaisson, Christine E; Ross, Douglas; Bogart, Laura M.; Coleman, Sharon M; Govender, Tessa; Robine, Marion; Erlwanger, Alison; Freedberg, Kenneth; Katz, Jeffrey; Walensky, Rochelle; Losina, ElenaBackground: 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.