Publications by authors named "Elena Losina"

402 Publications

Association of sinusitis and upper respiratory tract diseases with incident rheumatoid arthritis: A case-control study.

J Rheumatol 2021 Oct 15. Epub 2021 Oct 15.

Division of Rheumatology, Mayo Clinic, Rochester, Minnesota, USA; Division of Rheumatology, Inflammation, and Immunity; Brigham and Women's Hospital; Harvard Medical School; Boston, USA; Department of Quantitative Health Sciences, Mayo Clinic, Rochester, Minnesota, USA; Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, Minnesota, USA; Division of Pulmonary and Critical Care; Brigham and Women's Hospital and Harvard Medical School; Boston, USA; Department of Orthopedic Surgery; Brigham and Women's Hospital; Boston, USA. Funding: This study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases awards NIH-P30-AR072577 (VERITY Pilot & Feasibility award to VLK), K23 AR069688 (JAS), R03 AR075886 (JAS), L30 AR066953 (JAS), R03 HL148484 (TJD), and P30 AR070253 (Joint Biology Consortium). It was also supported by the R Bridge Award (JAS) from the Rheumatology Research Foundation. The funders had no role in the decision to publish or preparation of this manuscript. The content is solely the responsibility of the authors and does not necessarily represent the official views of Harvard University, its affiliated academic health care centers, or the National Institutes of Health. Conflict of interest: The authors declare no conflicts of interest related to this work. Corresponding Author: Vanessa L. Kronzer, 200 First Street SW, Rochester, MN 55905.

Objective: We aimed to determine whether specific respiratory tract diseases are associated with increased rheumatoid arthritis (RA) risk.

Methods: This case-control study within the Mass General Brigham Biobank matched newly diagnosed RA cases to three controls on age, sex, and electronic health record history. We identified RA using a validated algorithm and confirmed by medical record review. Respiratory tract disease exposure required one inpatient or two outpatient codes at least two years before index date of RA clinical diagnosis or matched date. Logistic regression models calculated odds ratios (OR) for RA with 95% confidence intervals (CI), adjusting for confounders. We then stratified by serostatus ("seropositive" was positive rheumatoid factor and/or anti-citrullinated protein antibodies) and smoking.

Results: We identified 741 RA cases and 2,223 controls (both median age 55, 76% female). Acute sinusitis (OR 1.61, 95% CI:1.05,2.45), chronic sinusitis (OR 2.16, 95% CI:1.39,3.35), and asthma (OR 1.39, 95% CI:1.03,1.87) were associated with increased risk of RA. Acute respiratory tract disease burden during the pre-index exposure period was also associated with increased RA risk (OR 1.30 per 10 codes, 95% CI:1.08,1.55). Acute pharyngitis was associated with seronegative (OR 1.68, 95% CI:1.02,2.74) but not seropositive RA; chronic rhinitis/pharyngitis was associated with seropositive (OR 2.46, 95% CI:1.01,5.99) but not seronegative RA. Respiratory tract diseases tended towards higher associations in smokers, especially >10 packyears (OR 1.52, 95% CI:1.02,2.27; p=0.10 for interaction).

Conclusion: Acute/chronic sinusitis and pharyngitis and acute respiratory burden increased RA risk. The mucosal paradigm of RA pathogenesis may involve the upper respiratory tract.
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http://dx.doi.org/10.3899/jrheum.210580DOI Listing
October 2021

Association between structural change over 18 months and subsequent symptom change in middle-aged persons treated for meniscal tear.

Arthritis Care Res (Hoboken) 2021 Oct 4. Epub 2021 Oct 4.

Section of General Internal Medicine, Massachusetts General Hospital, Harvard Medical School.

Background: Middle-aged subjects with meniscal tear treated with arthroscopic partial meniscectomy (APM) experience greater progression of damage to joint structures on imaging than subjects treated nonoperatively. It is unclear whether these changes are clinically relevant.

Methods: We used data from the MeTeOR (Meniscal Tear in Osteoarthritis Research) Trial of APM vs. physical therapy for subjects ≥ 45 years with knee pain, cartilage damage, and meniscal tear. We assessed whether change in cartilage surface area damage score (and other structural measures) from baseline to 18 months, assessed on MRI with MOAKS (MRI Osteoarthritis Knee Score), was associated with change in KOOS Pain (Knee Injury and Osteoarthritis Outcome Score; 0-100, 100=worst) from 18-60 months.

Results: The primary analysis included 168 subjects with complete MRI data at baseline and 18 months and KOOS data at 18 and 60 months. We did not observe clinically important associations between change in cartilage surface area score between baseline and 18 months and change in pain scores from 18-60 months. Pain scores in the worst tertile for cartilage surface area damage score progression worsened by 0.45 points more than in the best tertile (95% CI -4.45, 5.35). Similarly, we did not observe clinically important associations between changes in bone marrow lesions, osteophytes, or synovitis and subsequent pain.

Conclusions: We did not observe clinically important associations between early changes in cartilage damage and other structural measures and worsening in pain over the subsequent 3.5 years. Further follow-up is required to assess this association over a longer follow-up period.
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http://dx.doi.org/10.1002/acr.24796DOI Listing
October 2021

Perceptions of Physical Activity and the Use of Activity Monitors to Increase Activity Levels in Patients Undergoing Total Knee Replacement.

ACR Open Rheumatol 2021 Aug 19. Epub 2021 Aug 19.

Brigham and Women's Hospital, Harvard Medical School and Harvard Chan School of Public Health, Boston, Massachusetts.

Objective: Although most total knee replacement (TKR) recipients report less pain and improved function after TKR, many remain sedentary. We aimed to understand TKR recipients' motivations for undergoing TKR, perceptions of and goals related to physical activity, and the role, if any, that activity monitors might play in their recovery.

Methods: We conducted a qualitative study, individually interviewing 27 participants who had recently undergone or were about to undergo TKR. We conducted a thematic analysis to better understand participants' views of the benefits and barriers to physical activity after TKR.

Results: We identified nine themes and one subtheme that identify patients' initial motivations for undergoing TKR and may help TKR recipients achieve increased activity levels and a perceived successful recovery. Some key messages that emerged from our work include the following: exercise is necessary for physical and mental health, pain and functional limitation interfere with daily life, tracking steps motivates individuals to increase activity levels, and different incentives (for engaging in physical exercise and using an activity monitor) are effective for different individuals.

Conclusion: Participants recognized the health benefits of physical activity, and many believed activity monitor use would help them become more active after surgery. Both external and internal factors played a role in motivating individuals to become more active and wear activity monitors.
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http://dx.doi.org/10.1002/acr2.11324DOI Listing
August 2021

Impact of Preoperative and Incident Musculoskeletal Problematic Areas on Postoperative Outcomes After Total Knee Replacement.

ACR Open Rheumatol 2021 Sep 28;3(9):583-592. Epub 2021 Jul 28.

Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

Objective: To examine impact of pre-existing and incident problematic musculoskeletal (MSK) areas after total knee replacement (TKR) on postoperative 60-month Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain/function scores.

Methods: Using data from a randomized controlled trial of subjects undergoing TKR for osteoarthritis, we assessed problematic MSK areas in six body regions before TKR and 12, 24, 36, and 48 months after TKR. We defined the following two variables: 1) density count (number of problematic MSK areas occurring after TKR; range 0-24) and 2) cumulative density count (problematic MSK areas both before and after TKR, categorized into four levels: no preoperative areas and density count of 0-1 [reference group]; no preoperative areas and density count of 2 or more; one or more preoperative areas and density count of 0-1; and one or more preoperative areas and density count of 2 or greater). We evaluated the associations between categorized 60-month WOMAC and cumulative density count by ordinal logistic regression.

Results: Among 230 subjects, 24% reported one or more preoperative problematic MSK area. After TKR, 75% reported a density count of 0 to 1; 25% reported a density count of 2 or more. Compared with the reference group, each cumulative density count category was associated with an increased odds of having a higher category of 60-month WOMAC pain score, as follows: 2.97 (95% confidence interval [CI], 1.48-5.98) for no preoperative problematic areas and density count of 2 or greater, 3.31 (95% CI, 1.64-6.66) for one or more preoperative problematic areas and density count of 0 to 1, and 2.85 (95% CI, 0.97-8.39) for one or more preoperative problematic areas and density count of 2 or greater. Similar associations were observed with 60-month WOMAC function score.

Conclusion: In TKR recipients, the presence of problematic musculoskeletal areas beyond the index knee-preoperatively and/or postoperatively-was associated with worse 60-month WOMAC pain/function score.
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http://dx.doi.org/10.1002/acr2.11241DOI Listing
September 2021

The Cost-Effectiveness of Surgical Intervention for Spinal Metastases: A Model-Based Evaluation.

J Bone Joint Surg Am 2021 Jul 21. Epub 2021 Jul 21.

Department of Orthopaedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

Background: Operative and nonoperative treatments for spinal metastases are expensive interventions with a high rate of complications. We sought to determine the cost-effectiveness of a surgical procedure compared with nonoperative management as treatment for spinal metastases.

Methods: We constructed a Markov state-transition model with health states defined by ambulatory status and estimated the quality-adjusted life-years (QALYs) and costs for operative and nonoperative management of spine metastases. We considered 2 populations: 1 in which patients presented with independent ambulatory status and 1 in which patients presented with nonambulatory status due to acute (e.g., <48 hours) metastatic epidural compression. We defined the efficacy of each treatment as a likelihood of maintaining, or returning to, independent ambulation. Transition probabilities for the model, including the risks of mortality and becoming dependent or nonambulatory, were obtained from secondary data analysis and published literature. Costs were determined from Medicare reimbursement schedules. We conducted analyses over patients' remaining life expectancy from a health system perspective and discounted outcomes at 3% per year. We conducted sensitivity analyses to account for uncertainty in data inputs.

Results: Among patients presenting as independently ambulatory, QALYs were 0.823 for operative treatment and 0.800 for nonoperative treatment. The incremental cost-effectiveness ratio (ICER) for a surgical procedure was $899,700 per QALY. Among patients presenting with nonambulatory status, those undergoing surgical intervention accumulated 0.813 lifetime QALY, and those treated nonoperatively accumulated 0.089 lifetime QALY. The incremental cost-effectiveness ratio for a surgical procedure was $48,600 per QALY. The cost-effectiveness of a surgical procedure was most sensitive to the variability of its efficacy.

Conclusions: Our data suggest that the value to society of a surgical procedure for spinal metastases varies according to the features of the patient population. In patients presenting as nonambulatory due to acute neurologic compromise, surgical intervention provides good value (ICER, $48,600 per QALY). There is a low value for a surgical procedure performed for patients who are ambulatory at presentation (ICER, $899,700 per QALY).

Level Of Evidence: Economic and Decision Analysis Level III. See Instructions for Authors for a complete description of levels of evidence.
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http://dx.doi.org/10.2106/JBJS.21.00023DOI Listing
July 2021

Predicting Response to Tocilizumab Monotherapy in Rheumatoid Arthritis: A Real-world Data Analysis Using Machine Learning.

J Rheumatol 2021 09 1;48(9):1364-1370. Epub 2021 May 1.

S.C. Kim, Associate Professor of Medicine, MD, ScD, D.H. Solomon, Professor of Medicine, MD, MPH, Division of Rheumatology, and Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, Massachusetts, USA.

Objective: Tocilizumab (TCZ) has shown similar efficacy when used as monotherapy as in combination with other treatments for rheumatoid arthritis (RA) in randomized controlled trials (RCTs). We derived a remission prediction score for TCZ monotherapy (TCZm) using RCT data and performed an external validation of the prediction score using real-world data (RWD).

Methods: We identified patients in the Corrona RA registry who used TCZm (n = 452), and matched the design and patients from 4 RCTs used in previous work (n = 853). Patients were followed to determine remission status at 24 weeks. We compared the performance of remission prediction models in RWD, first based on variables determined in our prior work in RCTs, and then using an extended variable set, comparing logistic regression and random forest models. We included patients on other biologic disease-modifying antirheumatic drug monotherapies (bDMARDm) to improve prediction.

Results: The fraction of patients observed reaching remission on TCZm by their follow-up visit was 12% (n = 53) in RWD vs 15% (n = 127) in RCTs. Discrimination was good in RWD for the risk score developed in RCTs, with area under the receiver-operating characteristic curve (AUROC) of 0.69 (95% CI 0.62-0.75). Fitting the same logistic regression model to all bDMARDm patients in the RWD improved the AUROC on held-out TCZm patients to 0.72 (95% CI 0.63-0.81). Extending the variable set and adding regularization further increased it to 0.76 (95% CI 0.67-0.84).

Conclusion: The remission prediction scores, derived in RCTs, discriminated patients in RWD about as well as in RCTs. Discrimination was further improved by retraining models on RWD.
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http://dx.doi.org/10.3899/jrheum.201626DOI Listing
September 2021

The Value of Total Knee Replacement in Patients With Knee Osteoarthritis and a Body Mass Index of 40 kg/m or Greater : A Cost-Effectiveness Analysis.

Ann Intern Med 2021 06 23;174(6):747-757. Epub 2021 Mar 23.

Orthopaedic and Arthritis Center for Outcomes Research (OrACORe) and Policy and Innovation eValuation in Orthopaedic Treatments (PIVOT) Center, Brigham and Women's Hospital, Harvard Medical School, and Boston University School of Public Health, Boston, Massachusetts (E.L.).

Background: Total knee replacement (TKR) is an effective and cost-effective strategy for treating end-stage knee osteoarthritis. Greater risk for complications among TKR recipients with a body mass index (BMI) of 40 kg/m or greater has raised concerns about the value of TKR in this population.

Objective: To assess the value of TKR in recipients with a BMI of 40 kg/m or greater using a cost-effectiveness analysis.

Design: Osteoarthritis Policy Model to assess long-term clinical benefits, costs, and cost-effectiveness of TKR in patients with a BMI of 40 kg/m or greater.

Data Sources: Total knee replacement parameters from longitudinal studies and published literature, and costs from Medicare Physician Fee Schedules, the Healthcare Cost and Utilization Project, and published data.

Target Population: Recipients of TKR with a BMI of 40 kg/m or greater in the United States.

Time Horizon: Lifetime.

Perspective: Health care sector.

Intervention: Total knee replacement.

Outcome Measures: Cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs), discounted at 3% annually.

Results Of Base-case Analysis: Total knee replacement increased QALYs by 0.71 year and lifetime medical costs by $25 200 among patients aged 50 to 65 years with a BMI of 40 kg/m or greater, resulting in an ICER of $35 200. Total knee replacement in patients older than 65 years with a BMI of 40 kg/m or greater increased QALYs by 0.39 year and costs by $21 100, resulting in an ICER of $54 100.

Results Of Sensitivity Analysis: In TKR recipients with a BMI of 40 kg/m or greater and diabetes and cardiovascular disease, ICERs were below $75 000 per QALY. Results were most sensitive to complication rates and preoperative pain levels. In the probabilistic sensitivity analysis, at a $55 000-per-QALY willingness-to-pay threshold, TKR had a 100% and 90% likelihood of being a cost-effective strategy for patients aged 50 to 65 years and patients older than 65 years, respectively.

Limitation: Data are derived from several sources.

Conclusion: From a cost-effectiveness perspective, TKR offers good value in patients with a BMI of 40 kg/m or greater, including those with multiple comorbidities.

Primary Funding Source: National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health.
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http://dx.doi.org/10.7326/M20-4722DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8288249PMC
June 2021

Association Between Baseline "Meniscal symptoms" and Outcomes of Operative and Non-Operative Treatment of Meniscal Tear in Patients with Osteoarthritis.

Arthritis Care Res (Hoboken) 2021 Mar 1. Epub 2021 Mar 1.

Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, MA, United States.

Objective: Patients with meniscal tears reporting "meniscal symptoms" such as catching or locking, have traditionally undergone arthroscopy. We investigated whether patients with meniscal tears who report "meniscal symptoms" have greater improvement with arthroscopic partial meniscectomy (APM) than physical therapy (PT).

Methods: We used data from the Meniscal Tear in Osteoarthritis Research (MeTeOR) trial, which randomized participants with knee osteoarthritis (OA) and meniscal tear to APM or PT. The frequency of each "meniscal symptom" (clicking, catching, popping, intermittent locking, giving way, swelling) was measured at baseline and 6-months. We used linear regression models to determine whether the difference in improvement in KOOS Pain at 6-months between those treated with APM versus PT was modified by the presence of each "meniscal symptom". We also determined the percent of participants with resolution of "meniscal symptoms" by treatment group.

Results: We included 287 participants. The presence (vs. absence) of any of the "meniscal symptoms" did not modify the improvement in KOOS Pain between APM vs. PT by more than 0.5 SD (all p-interaction >0.05). APM led to greater resolution of intermittent locking and clicking than PT (locking 70% vs 46%, clicking 41% vs 25%). No difference in resolution of the other "meniscal symptoms" was observed.

Conclusion: "Meniscal symptoms" were not associated with improved pain relief. Although symptoms of clicking and intermittent locking had a greater reduction in the APM group, the presence of "meniscal symptoms" in isolation should not inform clinical decisions surrounding APM vs. PT in patients with meniscal tear and knee OA.
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http://dx.doi.org/10.1002/acr.24588DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8408275PMC
March 2021

Societal Cost of Opioid Use in Symptomatic Knee Osteoarthritis Patients in the United States.

Arthritis Care Res (Hoboken) 2021 Feb 24. Epub 2021 Feb 24.

Orthopaedic and Arthritis Center for Outcomes Research, Brigham and Women's Hospital, Boston, Massachusetts, United States of America.

Background: Symptomatic knee osteoarthritis (SKOA) is a chronic, disabling condition, requiring long-term pain management; over 800,000 SKOA patients in the USA use opioids chronically. We aim to characterize the societal economic burden of opioid use in this population.

Methods: We used the Osteoarthritis Policy Model, a validated computer simulation of SKOA, to estimate the opioid-related lifetime and annual cost generated by the USA SKOA population. We included direct medical, lost productivity, criminal justice, and diversion costs. We modeled the SKOA cohort with mean (SD) age 54 (14) years and Western Ontario and McMaster University pain score 29 (17) (0-100, 100-worst). We estimated annual costs of strong ($1,381) and weak ($671) opioid regimens using Medicare fee schedules, Red Book, the Federal Supply Schedule, and published literature. The annual lost productivity and criminal justice costs of opioid use disorder (OUD), obtained from published literature, were $11,387 and $4,264, per-person. The 2015-2016 Medicare Current Beneficiary Survey provided OUD prevalence. We conducted sensitivity analyses to examine the robustness of our estimates to uncertainty in input parameters.

Results: Assuming 5.1% prevalence of chronic strong opioid use, the total lifetime opioid-related cost generated by the USA SKOA population was estimated at $14.0 billion, of which only $7.45 billion (53%) were direct medical costs.

Conclusions: Lost productivity, diversion, and criminal justice costs comprise about half of opioid-related costs generated by the USA SKOA population. Reducing chronic opioid use may lead to a meaningful reduction in societal costs that can be used for other public health causes.
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http://dx.doi.org/10.1002/acr.24581DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8382774PMC
February 2021

The sequence of disease-modifying anti-rheumatic drugs: pathways to and predictors of tocilizumab monotherapy.

Arthritis Res Ther 2021 01 14;23(1):26. Epub 2021 Jan 14.

Chalmers University of Technology, Gothenburg, Sweden.

Background: There are numerous non-biologic and biologic disease-modifying anti-rheumatic drugs (bDMARDs) for rheumatoid arthritis (RA). Typical sequences of bDMARDs are not clear. Future treatment policies and trials should be informed by quantitative estimates of current treatment practice.

Methods: We used data from Corrona, a large real-world RA registry, to develop a method for quantifying sequential patterns in treatment with bDMARDs. As a proof of concept, we study patients who eventually use tocilizumab monotherapy (TCZm), an IL-6 antagonist with similar benefits used as monotherapy or in combination. Patients starting a bDMARD were included and were followed using a discrete-state Markov model, observing changes in treatments every 6 months and determining whether they used TCZm. A supervised machine learning algorithm was then employed to determine longitudinal patient factors associated with TCZm use.

Results: 7300 patients starting a bDMARD were followed for up to 5 years. Their median age was 58 years, 78% were female, median disease duration was 5 years, and 57% were seropositive. During follow-up, 287 (3.9%) reported use of TCZm with median time until use of 25.6 (11.5, 56.0) months. Eighty-two percent of TCZm use began within 3 years of starting any bDMARD. Ninety-three percent of TCZm users switched from TCZ combination, a TNF inhibitor, or another bDMARD. Very few patients are given TCZm as their first DMARD (0.6%). Variables associated with the use of TCZm included prior use of TCZ combination therapy, older age, longer disease duration, seronegative, higher disease activity, and no prior use of a TNF inhibitor.

Conclusions: Improved understanding of treatment sequences in RA may help personalize care. These methods may help optimize treatment decisions using large-scale real-world data.
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http://dx.doi.org/10.1186/s13075-020-02408-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7807904PMC
January 2021

Multivariable modeling of biomarker data from the phase 1 Foundation for the NIH Osteoarthritis Biomarkers Consortium.

Arthritis Care Res (Hoboken) 2021 Jan 9. Epub 2021 Jan 9.

Duke Molecular Physiology Institute and Division of Rheumatology, Department of Medicine, Duke University School of Medicine, Durham, NC, 27701, USA.

Objective: To determine the optimal combination of imaging and biochemical biomarkers to predict knee osteoarthritis (OA) progression.

Methods: Nested case-control study from the FNIH OA Biomarkers Consortium of participants with Kellgren-Lawrence grade 1-3 and complete biomarker data (n=539 to 550). Cases were knees with radiographic and pain progression between 24-48 months from baseline. Radiographic progression only was assessed in secondary analyses. Biomarkers (baseline and 24-month changes) with p<0.10 in univariate analysis were selected, including MRI (quantitative (Q) cartilage thickness and volume; semi-quantitative (SQ) MRI markers; bone shape and area; Q meniscal volume), radiographic (trabecular bone texture (TBT)), and serum and/or urine biochemical markers. Multivariable logistic regression models were built using three different step-wise selection methods (complex vs. parsimonious models).

Results: Among baseline biomarkers, the number of locations affected by osteophytes (SQ), Q central medial femoral and central lateral femoral cartilage thickness, patellar bone shape, and SQ Hoffa-synovitis predicted progression in most models (C-statistics 0.641-0.671). 24-month changes in SQ MRI markers (effusion-synovitis, meniscal morphology, and cartilage damage), Q central medial femoral cartilage thickness, Q medial tibial cartilage volume, Q lateral patellofemoral bone area, horizontal TBT (intercept term), and urine NTX-I predicted progression in most models (C-statistics 0.680-0.724). A different combination of imaging and biochemical biomarkers (baseline and 24-month change) predicted radiographic progression only, with higher C-statistics (0.716-0.832).

Conclusion: This study highlights the combination of biomarkers with potential prognostic utility in OA disease-modifying trials. Properly qualified, these biomarkers could be used to enrich future trials with participants likely to progress.
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http://dx.doi.org/10.1002/acr.24557DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8267050PMC
January 2021

Epidemiology of abdominal wall and groin hernia repairs in children.

Pediatr Surg Int 2021 May 1;37(5):587-595. Epub 2021 Jan 1.

Department of Surgery, Boston Children's Hospital, Boston, MA, USA.

Purpose: We sought to estimate the prevalence, incidence, and timing of surgery for elective and non-elective hernia repairs.

Methods: We performed a retrospective cohort study, abstracting data on children < 18 years from the 2005-2014 DoD Military Health System Data Repository, which includes > 3 million dependents of U.S. Armed Services members. Our primary outcome was initial hernia repair (inguinal, umbilical, ventral, or femoral), stratified by elective versus non-elective repair and by age. We calculated prevalence, incidence rate, and time from diagnosis to repair.

Results: 19,398 children underwent hernia repair (12,220 inguinal, 5761 umbilical, 1373 ventral, 44 femoral). Prevalence of non-elective repairs ranged from 6% (umbilical) to 22% (ventral). Incidence rates of elective repairs ranged from 0.03 [95% CI: 0.02-0.04] (femoral) to 8.92 [95% CI: 8.76-9.09] (inguinal) per 10,000 person-years, while incidence rates of non-elective repairs ranged from 0.005 [95% CI: 0.002-0.01] (femoral) to 0.68 [95% CI: 0.64-0.73] (inguinal) per 10,000 person-years. Inguinal (median = 20, interquartile range [IQR] = 0-46 days), ventral (median = 23, IQR = 5-62 days), and femoral hernias (median = 0, IQR = 0-12 days) were repaired more promptly and with less variation than umbilical hernias (median = 66, IQR = 23-422 days).

Conclusions: These data describe the burden of hernia repair in the U.S. The large variation in time between diagnosis and repair by hernia type identifies an important area of research to understand mechanisms underlying such heterogeneity and determine the ideal timing for repair.

Level Of Evidence: Prognosis study II.
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http://dx.doi.org/10.1007/s00383-020-04808-8DOI Listing
May 2021

Prevalence of Undiagnosed Subchondral Insufficiency Fractures of the Knee in Middle Age Adults with Knee Pain and Suspected Meniscal Tear.

Osteoarthr Cartil Open 2020 Dec 19;2(4). Epub 2020 Aug 19.

Orthopedic and Arthritis Center for Outcomes Research, Brigham and Women's Hospital, Boston, MA.

Objective: Symptomatic knee osteoarthritis (OA) and meniscal tear are often treated with weight-bearing exercises and without ordering advanced imaging (e.g. MRI). This may lead to missed diagnoses of subchondral insufficiency fracture of the knee (SIFK). Failure to diagnose SIFK has treatment implications, as patients with SIFK are typically managed with a period of reduced weight-bearing. The primary objective of this study is to determine the prevalence of undiagnosed SIFK among persons treated non-operatively for knee pain and suspected meniscal tear(s).

Methods: The randomized controlled trial, TeMPO (Treatment of Meniscal Problems and Osteoarthritis), enrolls subjects whose clinicians suspect concomitant meniscal tear and knee OA. TeMPO participants undergo MRI ordered by the study to confirm meniscal tear. All study-ordered MRIs revealing a fracture were reviewed by two study radiologists who noted features of the fracture and joint. We report prevalence of SIFK and clinical and imaging features on these subjects with 95% confidence intervals.

Results: Ten of the 340 study-ordered MRIs had SIFK, resulting in an estimated prevalence of 2.94% (95% CI: 1.15%, 4.71%). Eight of the ten participants with SIFK had fractures located medially. The femur was involved in five of these participants, tibia in four, and both in one. Five of the ten participants did not have meniscal tears.

Conclusions: This is the only reported estimate of undiagnosed SIFK in adults with knee pain, to our knowledge. Approximately 3% of patients managed with weight-bearing exercise for suspected meniscal tear may have SIFK, a diagnosis typically treated with reduced weight-bearing approaches.
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http://dx.doi.org/10.1016/j.ocarto.2020.100089DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7771884PMC
December 2020

Clinical Outcomes, Costs, and Cost-effectiveness of Strategies for Adults Experiencing Sheltered Homelessness During the COVID-19 Pandemic.

JAMA Netw Open 2020 12 1;3(12):e2028195. Epub 2020 Dec 1.

Division of General Internal Medicine, Massachusetts General Hospital, Boston.

Importance: Approximately 356 000 people stay in homeless shelters nightly in the United States. They have high risk of contracting coronavirus disease 2019 (COVID-19).

Objective: To assess the estimated clinical outcomes, costs, and cost-effectiveness associated with strategies for COVID-19 management among adults experiencing sheltered homelessness.

Design, Setting, And Participants: This decision analytic model used a simulated cohort of 2258 adults residing in homeless shelters in Boston, Massachusetts. Cohort characteristics and costs were adapted from Boston Health Care for the Homeless Program. Disease progression, transmission, and outcomes data were taken from published literature and national databases. Surging, growing, and slowing epidemics (effective reproduction numbers [Re], 2.6, 1.3, and 0.9, respectively) were examined. Costs were from a health care sector perspective, and the time horizon was 4 months, from April to August 2020.

Exposures: Daily symptom screening with polymerase chain reaction (PCR) testing of individuals with positive symptom screening results, universal PCR testing every 2 weeks, hospital-based COVID-19 care, alternative care sites (ACSs) for mild or moderate COVID-19, and temporary housing were each compared with no intervention.

Main Outcomes And Measures: Cumulative infections and hospital-days, costs to the health care sector (US dollars), and cost-effectiveness, as incremental cost per case of COVID-19 prevented.

Results: The simulated population of 2258 sheltered homeless adults had a mean (SD) age of 42.6 (9.04) years. Compared with no intervention, daily symptom screening with ACSs for pending tests or confirmed COVID-19 and mild or moderate disease was associated with 37% fewer infections (1954 vs 1239) and 46% lower costs ($6.10 million vs $3.27 million) at an Re of 2.6, 75% fewer infections (538 vs 137) and 72% lower costs ($1.46 million vs $0.41 million) at an Re of 1.3, and 51% fewer infections (174 vs 85) and 51% lower costs ($0.54 million vs $0.26 million) at an Re of 0.9. Adding PCR testing every 2 weeks was associated with a further decrease in infections; incremental cost per case prevented was $1000 at an Re of 2.6, $27 000 at an Re of 1.3, and $71 000 at an Re of 0.9. Temporary housing with PCR every 2 weeks was most effective but substantially more expensive than other options. Compared with no intervention, temporary housing with PCR every 2 weeks was associated with 81% fewer infections (376) and 542% higher costs ($39.12 million) at an Re of 2.6, 82% fewer infections (95) and 2568% higher costs ($38.97 million) at an Re of 1.3, and 59% fewer infections (71) and 7114% higher costs ($38.94 million) at an Re of 0.9. Results were sensitive to cost and sensitivity of PCR and ACS efficacy in preventing transmission.

Conclusions And Relevance: In this modeling study of simulated adults living in homeless shelters, daily symptom screening and ACSs were associated with fewer severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and decreased costs compared with no intervention. In a modeled surging epidemic, adding universal PCR testing every 2 weeks was associated with further decrease in SARS-CoV-2 infections at modest incremental cost and should be considered during future surges.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.28195DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7756240PMC
December 2020

College Campuses and COVID-19 Mitigation: Clinical and Economic Value.

Ann Intern Med 2021 04 21;174(4):472-483. Epub 2020 Dec 21.

Massachusetts General Hospital, Harvard Medical School, and Harvard T.H. Chan School of Public Health, Boston, Massachusetts (K.A.F.).

Background: Colleges in the United States are determining how to operate safely amid the coronavirus disease 2019 (COVID-19) pandemic.

Objective: To examine the clinical outcomes, cost, and cost-effectiveness of COVID-19 mitigation strategies on college campuses.

Design: The Clinical and Economic Analysis of COVID-19 interventions (CEACOV) model, a dynamic microsimulation model, was used to examine alternative mitigation strategies. The CEACOV model tracks infections accrued by students and faculty, accounting for community transmissions.

Data Sources: Data from published literature were used to obtain parameters related to COVID-19 and contact-hours.

Target Population: Undergraduate students and faculty at U.S. colleges.

Time Horizon: One semester (105 days).

Perspective: Modified societal.

Intervention: COVID-19 mitigation strategies, including social distancing, masks, and routine laboratory screening.

Outcome Measures: Infections among students and faculty per 5000 students and per 1000 faculty, isolation days, tests, costs, cost per infection prevented, and cost per quality-adjusted life-year (QALY).

Results Of Base-case Analysis: Among students, mitigation strategies reduced COVID-19 cases from 3746 with no mitigation to 493 with extensive social distancing and masks, and further to 151 when laboratory testing was added among asymptomatic persons every 3 days. Among faculty, these values were 164, 28, and 25 cases, respectively. Costs ranged from about $0.4 million for minimal social distancing to about $0.9 million to $2.1 million for strategies involving laboratory testing ($10 per test), depending on testing frequency. Extensive social distancing with masks cost $170 per infection prevented ($49 200 per QALY) compared with masks alone. Adding routine laboratory testing increased cost per infection prevented to between $2010 and $17 210 (cost per QALY gained, $811 400 to $2 804 600).

Results Of Sensitivity Analysis: Results were most sensitive to test costs.

Limitation: Data are from multiple sources.

Conclusion: Extensive social distancing with a mandatory mask-wearing policy can prevent most COVID-19 cases on college campuses and is very cost-effective. Routine laboratory testing would prevent 96% of infections and require low-cost tests to be economically attractive.

Primary Funding Source: National Institutes of Health.
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http://dx.doi.org/10.7326/M20-6558DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7755069PMC
April 2021

Does screening for depressive symptoms help optimize duloxetine use in knee OA patients with moderate pain? A cost-effectiveness analysis.

Arthritis Care Res (Hoboken) 2020 Nov 30. Epub 2020 Nov 30.

Orthopaedic and Arthritis Center for Outcomes Research (OrACORe) and Policy and Innovation eValuation in Orthopaedic Treatments (PIVOT) Center, Department of Orthopaedic Surgery Brigham and Women's Hospital, Boston, MA, 02115, USA.

Objective: Duloxetine is an FDA-approved treatment for both osteoarthritis (OA) pain and depression, but uptake of duloxetine in knee OA management varies. We examined the cost-effectiveness of adding duloxetine to knee OA care with or without depression screening.

Methods: We used the Osteoarthritis Policy Model, a validated computer microsimulation of knee OA, to examine the value of duloxetine for knee OA patients with moderate pain by comparing three strategies: 1) usual care (UC); 2) duloxetine for those who screen positive for depression on the Patient Health Questionnaire 9 (PHQ-9) + UC; and 3) universal duloxetine + UC. Outcomes included quality-adjusted life years (QALYs), lifetime direct medical costs, and incremental cost-effectiveness ratios (ICERs), discounted at 3% annually. Model inputs, drawn from published literature and national databases, included: annual cost of duloxetine, $721-$937; average pain reduction for duloxetine, 17.5 points on the WOMAC pain scale (0-100); likelihood of depression remission with duloxetine, 27.4%. We considered two willingness-to-pay (WTP) thresholds of $50,000/QALY and $100,000/QALY. We varied parameters related to the PHQ-9 and duloxetine's cost, efficacy, and toxicities to address uncertainty in model inputs.

Results: The screening strategy led to an additional 17 QALYs per 1,000 subjects and increased costs by $289/subject (ICER=$17,000/QALY). Universal duloxetine led to an additional 31 QALYs per 1,000 subjects and $1,205/subject (ICER=$39,300/QALY). Under the majority of sensitivity analyses, universal duloxetine was cost-effective at the $100,000/QALY threshold.

Conclusion: Adding duloxetine to usual care for knee OA patients with moderate pain, regardless of depressive symptoms, is cost-effective at frequently-used WTP thresholds.
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http://dx.doi.org/10.1002/acr.24519DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8164641PMC
November 2020

National utilization and inpatient safety measures of lumbar spinal fusion methods by race/ethnicity.

Spine J 2021 05 20;21(5):785-794. Epub 2020 Nov 20.

Harvard Medical School, 25 Shattuck St, Boston, MA 02115 USA; Division of General Medicine, Massachusetts General Hospital, 50 Staniford St, 9th floor, Boston, MA 02114 USA.

Background Context: Degenerative lumbar conditions are prevalent, disabling, and frequently managed with decompression and fusion. Black patients have lower spinal fusion rates than White patients.

Purpose: Determine whether specific lumbar fusion procedure utilization differs by race/ethnicity and whether length of stay (LOS) or inpatient complications differ by race/ethnicity after accounting for procedure performed.

Study Design: Large database retrospective cohort study PATIENT SAMPLE: Lumbar fusion recipients at least age 50 in the 2016 National Inpatient Sample with diagnoses of degenerative lumbar conditions.

Outcome Measures: Type of fusion procedure used and inpatient safety measures including LOS, prolonged LOS, inpatient medical and surgical complications, mortality, and cost.

Methods: We examined the association between race/ethnicity and the safety measures above. Covariates included several patient and hospital factors. We used multiple linear or logistic regression to determine the association between race and fusion type (PLF, P/TLIF, ALIF, PLF + P/TLIF, and PLF + ALIF [anterior-posterior fusion]) and to determine whether race was associated independently with inpatient safety measures, after adjustment for patient and hospital factors.

Results: Fusion method use did not differ among racial/ethnic groups, except for somewhat lower anterior-posterior fusion utilization in Black patients compared to White patients (crude odds ratio [OR]: 0.81 [0.67-0.97]). Inpatient safety measures differed by race/ethnicity for rates of prolonged LOS (Blacks 18.1%, Hispanics 14.5%, and Whites 11.7%), medical complications (Blacks 9.9%, Hispanics 8.7%, and Whites 7.7%), and surgical complications (Blacks 5.2%, Hispanics 6.9%, and Whites 5.4%). Differences persisted after adjustment for procedure type as well as patient and hospital factors. Blacks and Hispanics had higher risk for prolonged LOS compared to Whites (adjusted OR Blacks 1.39 [95% confidence interval {CI} 1.22-1.59]; Hispanics 1.24 [95% CI 1.02-1.52]). Blacks had higher risk for inpatient medical complications compared to Whites (adjusted OR 1.24 [95% CI 1.05-1.48]), and Hispanics had higher risk for inpatient surgical complications compared to Whites (adjusted OR 1.34 [95% CI 1.06-1.68]).

Conclusions: Fusion method use was generally similar between racial/ethnic groups. Inpatient safety measures, adjusted for procedure type, patient and hospital factors, were worse for Blacks and Hispanics.
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http://dx.doi.org/10.1016/j.spinee.2020.11.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8113062PMC
May 2021

Cost-effectiveness of public health strategies for COVID-19 epidemic control in South Africa: a microsimulation modelling study.

Lancet Glob Health 2021 02 11;9(2):e120-e129. Epub 2020 Nov 11.

Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, MA, USA; Division of Infectious Diseases, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Africa Health Research Institute, Durban, South Africa.

Background: Health-care resource constraints in low-income and middle-income countries necessitate the identification of cost-effective public health interventions to address COVID-19. We aimed to develop a dynamic COVID-19 microsimulation model to assess clinical and economic outcomes and cost-effectiveness of epidemic control strategies in KwaZulu-Natal province, South Africa.

Methods: We compared different combinations of five public health interventions: health-care testing alone, where diagnostic testing is done only for individuals presenting to health-care centres; contact tracing in households of cases; isolation centres, for cases not requiring hospital admission; mass symptom screening and molecular testing for symptomatic individuals by community health-care workers; and quarantine centres, for household contacts who test negative. We calibrated infection transmission rates to match effective reproduction number (R) estimates reported in South Africa. We assessed two main epidemic scenarios for a period of 360 days, with an R of 1·5 and 1·2. Strategies with incremental cost-effectiveness ratio (ICER) of less than US$3250 per year of life saved were considered cost-effective. We also did sensitivity analyses by varying key parameters (R values, molecular testing sensitivity, and efficacies and costs of interventions) to determine the effect on clinical and cost projections.

Findings: When R was 1·5, health-care testing alone resulted in the highest number of COVID-19 deaths during the 360-day period. Compared with health-care testing alone, a combination of health-care testing, contact tracing, use of isolation centres, mass symptom screening, and use of quarantine centres reduced mortality by 94%, increased health-care costs by 33%, and was cost-effective (ICER $340 per year of life saved). In settings where quarantine centres were not feasible, a combination of health-care testing, contact tracing, use of isolation centres, and mass symptom screening was cost-effective compared with health-care testing alone (ICER $590 per year of life saved). When R was 1·2, health-care testing, contact tracing, use of isolation centres, and use of quarantine centres was the least costly strategy, and no other strategies were cost-effective. In sensitivity analyses, a combination of health-care testing, contact tracing, use of isolation centres, mass symptom screening, and use of quarantine centres was generally cost-effective, with the exception of scenarios in which R was 2·6 and when efficacies of isolation centres and quarantine centres for transmission reduction were reduced.

Interpretation: In South Africa, strategies involving household contact tracing, isolation, mass symptom screening, and quarantining household contacts who test negative would substantially reduce COVID-19 mortality and would be cost-effective. The optimal combination of interventions depends on epidemic growth characteristics and practical implementation considerations.

Funding: US National Institutes of Health, Royal Society, Wellcome Trust.
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http://dx.doi.org/10.1016/S2214-109X(20)30452-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7834260PMC
February 2021

Factors influencing physician recommendation for intra-articular therapies in osteoarthritis: A qualitative study.

Arthritis Care Res (Hoboken) 2020 Nov 9. Epub 2020 Nov 9.

Orthopedic and Arthritis Center for Outcomes Research, Brigham and Women's Hospital, Boston, MA, USA.

Objective: Several current and many emerging osteoarthritis (OA) treatments are intra-articular (IA) injections. However, little is known about physicians' perceptions and beliefs regarding IA injections or their considerations when deciding whether to recommend them to patients. We aimed to investigate physician-perceived benefits and drawbacks of offering IA injections.

Methods: We conducted individual interviews with orthopedic surgeons, rheumatologists, and physiatrists who treat patients with knee OA. We conducted a thematic analysis to identify factors that physicians weigh when making IA injection recommendations.

Results: We interviewed 18 physicians from academic and community practices. We identified four categories of themes that influenced providers' recommendations to their patients regarding injections: 1) the physician's knowledge, beliefs, and concerns, including their propensity to rely on guidelines versus clinical experience, and understanding of the efficacy and risks associated with injectables, such as possible cartilage damage; 2) the characteristics of the injectable product, such as ease or number of administrations needed; 3) individual patient-specific factors, including OA severity, comorbidities, and patient preference for and expectations of specific IA injections; and 4) financial and administrative factors, including insurance coverage and out-of-pocket costs.

Conclusion: Physicians factor the uncertain efficacy of injectable treatments and the need to manage patient expectations into their decision to offer IA therapies. Some providers relied on evidence and guidelines while others were swayed more by clinical experience. High out-of-pocket costs were seen as a barrier to use. These findings may help in the delivery of IA injections for OA and in development of injectable products.
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http://dx.doi.org/10.1002/acr.24502DOI Listing
November 2020

Changing contextual factors from baseline to 9-months post-HIV diagnosis predict 5-year mortality in Durban, South Africa.

AIDS Care 2020 Nov 2:1-8. Epub 2020 Nov 2.

Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, MA, USA.

Changes in an individual's contextual factors following HIV diagnosis may influence long-term outcomes. We evaluated how changes to contextual factors between HIV diagnosis and 9-month follow-up predict 5-year mortality among HIV-infected individuals in Durban, South Africa enrolled in the Sizanani Trial (NCT01188941). We used random survival forests to identify 9-month variables and changes from baseline predictive of time to mortality. We incorporated these into a Cox proportional hazards model including age, sex, and starting ART by 9 months , 9-month social support and competing needs, and changes in mental health between baseline and 9 months. Among 1,154 participants with South African ID numbers, 900 (78%) had baseline and 9-month data available of whom 109 (12%) died after 9-month follow-up. Those who reported less social support at 9 months had a 16% higher risk of mortality. Participants who went without basic needs or healthcare at 9 months had a 2.6 times higher hazard of death compared to participants who did not. Low social support and competing needs at 9-month follow-up substantially increase long-term mortality risk. Reassessing contextual factors during follow-up and targeting interventions to increase social support and affordability of care may reduce long-term mortality for HIV-infected individuals in South Africa.
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http://dx.doi.org/10.1080/09540121.2020.1837338DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8088454PMC
November 2020

Clinician Experiences in Treatment Decision-Making for Patients with Spinal Metastases: A Qualitative Study.

J Bone Joint Surg Am 2021 Jan;103(1):e1

Departments of Orthopaedic Surgery (L.B.B., K.R.A., J.A.B., E.L., J.N.K., and A.J.S.), Neurosurgery (D.L.S.), and Radiation Oncology (T.A.B.), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

Background: Effective management of metastatic disease requires multidisciplinary input and entails high risk of disease-related and treatment-related morbidity and mortality. The factors that influence clinician decision-making around spinal metastases are not well understood. We conducted a qualitative study that included a multidisciplinary cohort of physicians to evaluate the decision-making process for treatment of spinal metastases from the clinician's perspective.

Methods: We recruited operative and nonoperative clinicians, including orthopaedic spine surgeons, neurosurgeons, radiation oncologists, and physiatrists, from across North America to participate in either a focus group or a semistructured interview. All interviews were audiorecorded and transcribed verbatim. We then performed a thematic analysis using all of the available transcript data. Investigators sequentially coded transcripts and identified recurring themes that encompass overarching patterns in the data and directly bear on the guiding study question. This was followed by the development of a thematic map that visually portrays the themes, the subthemes, and their interrelatedness, as well as their influence on treatment decision-making.

Results: The thematic analysis revealed that numerous factors influence provider-based decision-making for patients with spinal metastases, including clinical elements of the disease process, treatment guidelines, patient preferences, and the dynamics of the multidisciplinary care team. The most prominent feature that resonated across all of the interviews was the importance of multidisciplinary care and the necessity of cohesion among a team of diverse health-care providers. Respondents emphasized aspects of care-team dynamics, including effective communication and intimate knowledge of team-member preferences, as necessary for the development of appropriate treatment strategies. Participants maintained that the primary role in decision-making should remain with the patient.

Conclusions: Numerous factors influence provider-based decision-making for patients with spinal metastases, including multidisciplinary team dynamics, business pressure, and clinician experience. Participants maintained a focus on shared decision-making with patients, which contrasts with patient preferences to defer decisions to the physician, as described in prior work.

Clinical Relevance: The results of this thematic analysis document the numerous factors that influence provider-based decision-making for patients with spinal metastases. Our results indicate that provider decisions regarding treatment are influenced by a combination of clinical characteristics, perceptions of patient quality of life, and the patient's preferences for care.
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http://dx.doi.org/10.2106/JBJS.20.00334DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8268460PMC
January 2021

Psychosocial Predictors of Upper Extremity Transplantation Outcomes: A Review of the International Registry 1998-2016.

Plast Reconstr Surg Glob Open 2020 Sep 23;8(9):e3133. Epub 2020 Sep 23.

Division of Plastic Surgery, Brigham and Women's Hospital, Boston, Mass.

Background: Upper extremity transplantation (UET) is becoming increasingly common. This article attempts to collate data from cases contributing to the International Registry on Hand and Composite Tissue Transplantation (IRHCTT), define psychosocial themes perceived as predictors of success using statistical methods, and provide an objective measure for optimization and selection of candidates.

Methods: The IRHCTT provided anonymous data on UET recipients. A supplementary psychosocial survey was developed focusing on themes of depression, posttraumatic stress disorder (PTSD), anxiety, interpersonal functioning and dependence, compliance, chronic pain, social support, quality of life, and patient expectations. We determined the risk of transplant loss and psychological factors associated with higher risk of transplant loss.

Results: Sixty-two UET recipients reported to the IRHCTT. Forty-three psychosocial surveys (68%) were received, with 38 (88%) having intact transplants and 5 (12%) being amputated. Among recipients with a diagnosis of anxiety (N = 29, 67%), 5 (17%) reported transplant loss ( = 0.03). Among those with depression (N = 14, 33%), 2 recipients (14%) has transplant loss ( = 0.17); while 4 recipients (22%) with PTSD (N = 18, 42%) had transplant loss ( = 0.01). Of participants active in occupational therapy (N = 28, 65%), 2 (7%) reported transplant loss ( = 0.09). Of recipients with realistic functional expectations (N = 34, 79%), 2 (6%) had transplant loss versus 3 (34%) who were felt to not have realistic expectations (N = 9, 21%, = 0.05). Recipients with strong family support (N = 33, 77%) had a lower risk of transplant loss compared with poor or fair family support (N = 10, 23%), but did not reach statistical significance (6% versus 30%, = 0.14).

Conclusion: Anxiety, depression, PTSD, participation in occupational therapy, expectations for posttransplant function, and family support are associated with postsurgical transplant status.
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http://dx.doi.org/10.1097/GOX.0000000000003133DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7544328PMC
September 2020

The impact of user fees on uptake of HIV services and adherence to HIV treatment: Findings from a large HIV program in Nigeria.

PLoS One 2020 8;15(10):e0238720. Epub 2020 Oct 8.

Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, Massachusetts, United States of America.

Background: Global HIV funding cutbacks have been accompanied by the adoption of user fees to address funding gaps in treatment programs. Our objective was to assess the impact of user fees on HIV care utilization and medication adherence in Nigeria.

Methods: We conducted a retrospective analysis of patients enrolled in care before (October 2012-September 2013) and after (October 2014-September 2015) the introduction of user fees in a Nigerian clinic. We assessed pre- vs. post-user fee patient characteristics and enrollment trends, and determined risk of care interruption, loss to follow-up, and optimal medication adherence.

Results: After fees were instituted, there was a 66% decline in patient enrollment and 75% decline in number of ART doses dispensed. There was no difference in the proportion of female clients (64% vs 63%, p = 0.46), average age (36 vs. 37 years, p = 0.15), or median baseline CD4 (220/ul vs. 222/uL, p = 0.24) in pre- and post-fee cohorts. There was an increase in clients employed and/or had tertiary education (24% vs. 32%, p<0.001). Compared to pre-fee patients, the post-fee period had a 48% decreased risk of care interruption (aRR = 0.52, 95%CI:0.39-0.69), 22% decreased LTFU risk (aRR = 0.64, 95%CI:0.96), and 27% decreased odds of optimal medication adherence (aOR = 0.7, 3 95%CI 0.59-0.89).

Conclusions: Patients enrolled in care after introduction of user fees in Nigeria were more likely to be educated or employed, and effectively retained in care after starting ART. However, fees were accompanied by a drastic reduction in new patient enrollment, suggesting that many patients may have been marginalized from HIV care.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0238720PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7544141PMC
November 2020

Patient perspectives surrounding intra-articular injections for knee osteoarthritis: A qualitative study.

Arthritis Care Res (Hoboken) 2020 Oct 7. Epub 2020 Oct 7.

Orthopedic and Arthritis Center for Outcomes Research, Brigham and Women's Hospital, Boston, MA, USA.

Objective: Intra-articular (IA) injections are used frequently for knee osteoarthritis (OA), but little is known about patients' attitudes towards these therapies. We aimed to better understand patients' perceptions of the facilitators of and barriers to IA injections for knee OA.

Methods: We conducted a qualitative, descriptive/exploratory study and held focus groups and individual interviews with participants with knee OA, including some who had received IA injections and others who had not received IA injections. We conducted a thematic analysis to identify themes describing the factors participants found influential when deciding whether to try an IA injection.

Results: We held three focus groups with 12 participants and conducted three individual interviews (15 participants total). We identified four themes that shaped participants' decisions to receive a specific injection: 1) the impact of OA on participants' lives; 2) participants' attitudes and concerns, including desire to avoid surgery, willingness to accept uncertain outcomes, and concerns about side effects and dependence; 3) the way participants gathered and processed information from physicians, peers, and the internet; and 4) availability of injectable products. Participants weighed the desire to regain function and delay surgery with concerns about side effects, uncertain efficacy, and costs.

Conclusion: Participants were concerned about the effectiveness, toxicity, availability, and cost of injectable products. They balanced disparate sources of information, uncertain outcomes, limited product availability, and other injection-related concerns with a desire to decrease pain. These findings can provide clinicians, investigators, and public health professionals with insights into challenges patients face when making injection decisions.
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http://dx.doi.org/10.1002/acr.24477DOI Listing
October 2020

Identifying and predicting longitudinal trajectories of care for people newly diagnosed with HIV in South Africa.

PLoS One 2020 21;15(9):e0238975. Epub 2020 Sep 21.

Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.

Background: Predicting long-term care trajectories at the time of HIV diagnosis may allow targeted interventions. Our objective was to uncover distinct CD4-based trajectories and determine baseline demographic, clinical, and contextual factors associated with trajectory membership.

Methods: We used data from the Sizanani trial (NCT01188941), in which adults were enrolled prior to HIV testing in Durban, South Africa from August 2010-January 2013. We ascertained CD4 counts from the National Health Laboratory Service over 5y follow-up. We used group-based statistical modeling to identify groups with similar CD4 count trajectories and Bayesian information criteria to determine distinct CD4 trajectories. We evaluated baseline factors that predict membership in specific trajectories using multinomial logistic regression. We examined calendar year of participant enrollment, age, gender, cohabitation, TB positivity, self-identified barriers to care, and ART initiation within 3 months of diagnosis.

Results: 688 participants had longitudinal data available. Group-based trajectory modeling identified four distinct trajectories: one with consistently low CD4 counts (21%), one with low CD4 counts that increased over time (22%), one with moderate CD4 counts that remained stable (41%), and one with high CD4 counts that increased over time (16%). Those with higher CD4 counts at diagnosis were younger, less likely to have TB, and less likely to identify barriers to care. Those in the least favorable trajectory (consistently low CD4 count) were least likely to start ART within 3 months.

Conclusions: One-fifth of people newly-diagnosed with HIV presented with low CD4 counts that failed to rise over time. Less than 40% were in a trajectory characterized by increasing CD4 counts. Patients in more favorable trajectories were younger, less likely to have TB, and less likely to report barriers to healthcare. Better understanding barriers to early care engagement and ART initiation will be necessary to improve long-term clinical outcomes.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0238975PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7505419PMC
October 2020

Clinical Impact, Costs, and Cost-Effectiveness of Expanded SARS-CoV-2 Testing in Massachusetts.

Clin Infect Dis 2020 Sep 18. Epub 2020 Sep 18.

Division of Infectious Diseases, Department of Medicine, Massachusetts General Hospital, Boston, MA.

Background: We projected the clinical and economic impact of alternative testing strategies on COVID-19 incidence and mortality in Massachusetts using a microsimulation model.

Methods: We compared four testing strategies: 1) Hospitalized: PCR testing only patients with severe/critical symptoms warranting hospitalization; 2) Symptomatic: PCR for any COVID-19-consistent symptoms, with self-isolation if positive; 3) Symptomatic+asymptomatic-once: Symptomatic and one-time PCR for the entire population; and, 4) Symptomatic+asymptomatic-monthly: Symptomatic with monthly re-testing for the entire population. We examined effective reproduction numbers (Re, 0.9-2.0) at which policy conclusions would change. We assumed homogeneous mixing among the Massachusetts population (excluding those residing in long-term care facilities). We used published data on disease progression and mortality, transmission, PCR sensitivity/specificity (70/100%) and costs. Model-projected outcomes included infections, deaths, tests performed, hospital-days, and costs over 180-days, as well as incremental cost-effectiveness ratios (ICER, $/quality-adjusted life-year [QALY]).

Results: At Re 0.9, Symptomatic+asymptomatic-monthly vs. Hospitalized resulted in a 64% reduction in infections and a 46% reduction in deaths, but required >66-fold more tests/day with 5-fold higher costs. Symptomatic+asymptomatic-monthly had an ICER <$100,000/QALY only when Re ≥1.6; when test cost was ≤$3, every 14-day testing was cost-effective at all Re examined.

Conclusions: Testing people with any COVID-19-consistent symptoms would be cost-saving compared to testing only those whose symptoms warrant hospital care. Expanding PCR testing to asymptomatic people would decrease infections, deaths, and hospitalizations. Despite modest sensitivity, low-cost, repeat screening of the entire population could be cost-effective in all epidemic settings.
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http://dx.doi.org/10.1093/cid/ciaa1418DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7543346PMC
September 2020

Impact of reported NSAID "allergies" on opioid use disorder in back pain.

J Allergy Clin Immunol 2021 04 9;147(4):1413-1419. Epub 2020 Sep 9.

Division of Allergy and Clinical Immunology, Department of Medicine, Brigham and Women's Hospital, Boston, Mass; Harvard Medical School, Boston, Mass.

Background: It is crucial to identify patients at highest risk for opioid use disorder (OUD) and to address challenges in reducing opioid use. Reported nonsteroidal anti-inflammatory drug (NSAID) allergies may predispose to use of stronger pain medications and potentially to OUD.

Objective: We sought to investigate the clinical impact of reported NSAID allergy on OUD in patients with chronic back pain.

Methods: We conducted a retrospective study of adults receiving care at a tertiary health care system from January 1, 2013, to December 31, 2018. Back pain and OUD were identified using administrative data algorithms. We used propensity score matching and logistic regression to estimate the impact of self-reported NSAID adverse drug reactions (ADRs) on risk of OUD, adjusting for other relevant clinical information.

Results: Of 47,114 patients with chronic back pain, 3,620 (7.7%) had a reported NSAID ADR. In an adjusted propensity score-matched analysis, patients with NSAID ADRs had higher odds (odds ratio, 1.34; 95% CI, 1.07-1.67) of developing OUD as compared with those without NSAID ADRs. Additional risk factors for OUD included younger age, male sex, Medicaid insurance, Medicare insurance, higher number of inpatient and outpatient visits in the previous year, and comorbid anxiety and depression. Patients with listed NSAID ADRs also had higher odds of a documented opioid prescription during the study period (odds ratio, 1.22; 95% CI, 1.11-1.34).

Conclusions: Adults with chronic back pain and reported NSAID ADRs are at a higher risk of developing OUD and receiving opioid analgesics, even after accounting for comorbidities and health care utilization. Allergy evaluation is critical for potential delabeling of patients with reported NSAID allergies and chronic pain.
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http://dx.doi.org/10.1016/j.jaci.2020.08.025DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7995999PMC
April 2021

College campuses and COVID-19 mitigation: clinical and economic value.

medRxiv 2020 Sep 5. Epub 2020 Sep 5.

Background: Decisions around US college and university operations will affect millions of students and faculty amidst the COVID-19 pandemic. We examined the clinical and economic value of different COVID-19 mitigation strategies on college campuses.

Methods: We used the Clinical and Economic Analysis of COVID-19 interventions (CEACOV) model, a dynamic microsimulation that tracks infections accrued by students and faculty, accounting for community transmissions. Outcomes include infections, $/infection-prevented, and $/quality-adjusted-life-year ($/QALY). Strategies included extensive social distancing (ESD), masks, and routine laboratory tests (RLT). We report results per 5,000 students (1,000 faculty) over one semester (105 days).

Results: Mitigation strategies reduced COVID-19 cases among students (faculty) from 3,746 (164) with no mitigation to 493 (28) with ESD and masks, and further to 151 (25) adding RLTq3 among asymptomatic students and faculty. ESD with masks cost $168/infection-prevented ($49,200/QALY) compared to masks alone. Adding RLTq3 ($10/test) cost $8,300/infection-prevented ($2,804,600/QALY). If tests cost $1, RLTq3 led to a favorable cost of $275/infection-prevented ($52,200/QALY). No strategies without masks were cost-effective.

Conclusion: Extensive social distancing with mandatory mask-wearing could prevent 87% of COVID-19 cases on college campuses and be very cost-effective. Routine laboratory testing would prevent 96% of infections and require low cost tests to be economically attractive.
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http://dx.doi.org/10.1101/2020.09.03.20187062DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7480037PMC
September 2020

Clinical Outcomes, Costs, and Cost-effectiveness of Strategies for People Experiencing Sheltered Homelessness During the COVID-19 Pandemic.

medRxiv 2020 Oct 20. Epub 2020 Oct 20.

Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.

Importance: Approximately 356,000 people stay in homeless shelters nightly in the US. They are at high risk for COVID-19.

Objective: To assess clinical outcomes, costs, and cost-effectiveness of strategies for COVID-19 management among sheltered homeless adults.

Design: We developed a dynamic microsimulation model of COVID-19 in sheltered homeless adults in Boston, Massachusetts. We used cohort characteristics and costs from Boston Health Care for the Homeless Program. Disease progression, transmission, and outcomes data were from published literature and national databases. We examined surging, growing, and slowing epidemics (effective reproduction numbers [R] 2.6, 1.3, and 0.9). Costs were from a health care sector perspective; time horizon was 4 months, from April to August 2020.

Setting & Participants: Simulated cohort of 2,258 adults residing in homeless shelters in Boston.

Interventions: We assessed daily symptom screening with polymerase chain reaction (PCR) testing of screen-positives, universal PCR testing every 2 weeks, hospital-based COVID-19 care, alternate care sites [ACSs] for mild/moderate COVID-19, and temporary housing, each compared to no intervention.

Main Outcomes And Measures: Cumulative infections and hospital-days, costs to the health care sector (US dollars), and cost-effectiveness, as incremental cost per case prevented of COVID-19.

Results: We simulated a population of 2,258 sheltered homeless adults with mean age of 42.6 years. Compared to no intervention, daily symptom screening with ACSs for pending tests or confirmed COVID-19 and mild/moderate disease led to 37% fewer infections and 46% lower costs (R=2.6), 75% fewer infections and 72% lower costs (R=1.3), and 51% fewer infections and 51% lower costs (R=0.9). Adding PCR testing every 2 weeks further decreased infections; incremental cost per case prevented was $1,000 (R=2.6), $27,000 (R=1.3), and $71,000 (R=0.9). Temporary housing with PCR every 2 weeks was most effective but substantially more costly than other options. Results were sensitive to cost and sensitivity of PCR and ACS efficacy in preventing transmission.

Conclusions & Relevance: In this modeling study of simulated adults living in homeless shelters, daily symptom screening and ACSs were associated with fewer COVID-19 infections and decreased costs compared with no intervention. In a modeled surging epidemic, adding universal PCR testing every 2 weeks was associated with further decrease in COVID-19 infections at modest incremental cost and should be considered during future surges.
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http://dx.doi.org/10.1101/2020.08.07.20170498DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7430611PMC
October 2020

Association Between Preoperative Radiographic Severity of Osteoarthritis and Patient-Reported Outcomes of Total Knee Replacement.

JB JS Open Access 2020 Jul-Sep;5(3). Epub 2020 Jul 9.

Department of Orthopedic Surgery (J.K.L., H.Y.Y., J.E.C., E.L., and J.N.K.), Division of Rheumatology, Immunology, and Allergy (J.N.K.), and The Orthopaedic and Arthritis Center for Outcomes Research (OrACORe) (H.Y.Y., J.E.C., E.L., and J.N.K.), Brigham and Women's Hospital, Boston, Massachusetts.

Background: The goal of this study was to investigate the association between preoperative radiographic severity of knee osteoarthritis (OA) and patient-reported outcomes following total knee replacement.

Methods: We used data from a prospective cohort study of individuals who underwent total knee replacement at a high-volume medical center. Patient-reported outcomes included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score and the Knee injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) subscore, assessed preoperatively and 2 years postoperatively. We measured preoperative radiographic OA severity using the Osteoarthritis Research Society International (OARSI) Atlas score, dichotomized at the median. We assessed the association between radiographic OA severity and postoperative patient-reported outcomes in bivariate analyses and in multivariable linear regression, with adjustment for age, sex, body mass index, and comorbidity score.

Results: The analytic cohort included 240 patients with a mean age at surgery of 66.6 years (standard deviation, 8 years); 61% were female. The median total OARSI radiographic severity score was 10 (range, 3 to 17). The cohort improved substantially at 2 years following total knee replacement, with WOMAC pain and KOOS ADL score improvements on the order of 30 points. We did not observe significant or clinically important differences in pain relief or functional improvement between patients with milder and more severe radiographic OA. Sensitivity analyses using other radiographic assessment measures yielded similar findings.

Conclusions: Total knee replacement offers substantial symptomatic relief and functional improvement regardless of preoperative radiographic OA severity.

Level Of Evidence: Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.
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http://dx.doi.org/10.2106/JBJS.OA.19.00073DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7386538PMC
July 2020
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