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Objective: Walk With Ease (WWE) is an effective low-cost walking program. We estimated the budget impact of implementing WWE in persons with knee osteoarthritis (OA) as a measure of affordability that can inform payers’ funding decisions. Methods: We estimated changes in two-year healthcare costs with and without WWE. We used the Osteoarthritis Policy (OAPol) Model to estimate per-person medical expenditures. We estimated total and per-member-per-month (PMPM) costs of funding WWE for a hypothetical insurance plan with 75,000 members under two conditions: 1) all individuals aged 45+ with knee OA eligible for WWE, and 2) inactive and insufficiently active individuals aged 45+ with knee OA eligible. In sensitivity analyses, we varied WWE cost and efficacy and considered productivity costs. Results: With eligibility unrestricted by activity level, implementing WWE results in an additional $1,002,408 to the insurance plan over two years ($0.56 PMPM). With eligibility restricted to inactive and insufficiently active individuals, funding WWE results in an additional $571,931 over two years ($0.32 PMPM). In sensitivity analyses, when per-person costs of $10 to $1000 were added with 10–50% decreases in failure rate (enhanced sustainability of WWE benefits), two-year budget impact varied from $242,684 to $6,985,674 with unrestricted eligibility and from -$43,194 (cost-saving) to $4,484,122 with restricted eligibility. Conclusion: Along with the cost-effectiveness of WWE at widely accepted willingness-to-pay thresholds, these results can inform payers in deciding to fund WWE. In the absence of accepted thresholds to define affordability, these results can assist in comparing the affordability of WWE with other behavioral interventions.

Background: Osteoarthritis (OA), the leading cause of disability among adults, has no cure and is associated with significant comorbidities. The premise of this randomized clinical trial is that, in a population at risk, a 48-month program of dietary weight loss and exercise will result in less incident structural knee OA compared to control. Methods/design: The Osteoarthritis Prevention Study (TOPS) is a Phase III, assessor-blinded, 48-month, parallel 2 arm, multicenter randomized clinical trial designed to reduce the incidence of structural knee OA. The study objective is to assess the effects of a dietary weight loss, exercise, and weight-loss maintenance program in preventing the development of structural knee OA in females at risk for the disease. TOPS will recruit 1230 ambulatory, community dwelling females with obesity (Body Mass Index (BMI) ​≥ ​30 ​kg/m2) and aged ≥50 years with no radiographic (Kellgren-Lawrence grade ≤1) and no magnetic resonance imaging (MRI) evidence of OA in the eligible knee, with no or infrequent knee pain. Incident structural knee OA (defined as tibiofemoral and/or patellofemoral OA on MRI) assessed at 48-months from intervention initiation using the MRI Osteoarthritis Knee Score (MOAKS) is the primary outcome. Secondary outcomes include knee pain, 6-min walk distance, health-related quality of life, knee joint loading during gait, inflammatory biomarkers, and self-efficacy. Cost effectiveness and budgetary impact analyses will determine the value and affordability of this intervention. Discussion: This study will assess the efficacy and cost effectiveness of a dietary weight loss, exercise, and weight-loss maintenance program designed to reduce incident knee OA. Trial registration: ClinicalTrials.gov Identifier: NCT05946044.

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

Objective: The Walk With Ease (WWE) program was developed by the Arthritis Foundation to help people with arthritis learn to exercise safely and improve arthritis symptoms. We sought to establish the value of the WWE program. Methods: We used the Osteoarthritis Policy (OAPol) Model, a widely published and validated computer simulation of knee osteoarthritis (OA), to assess the cost-effectiveness of WWE in knee OA. We derived model inputs using data from a workplace wellness initiative in Montana that offered WWE to state employees. Our primary outcomes were quality-adjusted life years (QALYs) and costs over a 2-year period, which we used to calculate the incremental cost-effectiveness ratio (ICER). The base case analysis was restricted to subjects who were inactive or insufficiently active (

Exon 27 of the tumor suppressor BRCA2 encodes a portion of the protein crucial for DNA repair, genome maintenance, and tumor suppression. Here the authors show that this domain binds DNA and the RAD51 recombinase to enhance the assembly of RAD51-DNA complexes.

Objective We examined the cost‐effectiveness of treatment strategies for concomitant meniscal tear and knee osteoarthritis (OA) involving arthroscopic partial meniscectomy surgery and physical therapy (PT). Methods We used the Osteoarthritis Policy Model, a validated Monte Carlo microsimulation, to compare three strategies, 1) PT‐only, 2) immediate surgery, and 3) PT + optional surgery, for participants whose pain persists following initial PT. We modeled a cohort with baseline meniscal tear, OA, and demographics from the Meniscal Tear in Osteoarthritis Research (MeTeOR) trial of arthroscopic partial meniscectomy versus PT. We estimated risks and costs of arthroscopic partial meniscectomy complications and accounted for heightened OA progression post surgery using published data. We estimated surgery use rates and treatment efficacies using MeTeOR data. We considered a 5‐year time horizon, discounted costs, and quality‐adjusted life‐years (QALYs) 3% per year and conducted sensitivity analyses. We report incremental cost‐effectiveness ratios. Results Relative to PT‐only, PT + optional surgery added 0.0651 QALY and $2,010 over 5 years (incremental cost‐effectiveness ratio = $30,900 per QALY). Relative to PT + optional surgery, immediate surgery added 0.0065 QALY and $3080 (incremental cost‐effectiveness ratio = $473,800 per QALY). Incremental cost‐effectiveness ratios were sensitive to optional surgery efficacy in the PT + optional surgery strategy. In the probabilistic sensitivity analysis, PT + optional surgery was cost‐effective in 51% of simulations at willingness‐to‐pay thresholds of both $50,000 per QALY and $100,000 per QALY. Conclusion First‐line arthroscopic partial meniscectomy has a prohibitively high incremental cost‐effectiveness ratio. Under base case assumptions, second‐line arthroscopic partial meniscectomy offered to participants with persistent pain following initial PT is cost‐effective at willingness‐to‐pay thresholds between $31,000 and $473,000 per QALY. Our analyses suggest that arthroscopic partial meniscectomy can be a high‐value treatment option for patients with meniscal tear and OA when performed following an initial PT course and should remain a covered treatment option.

Objective: Inflammation, manifesting as effusion and synovitis, is thought to contribute to pain in knee osteoarthritis (OA). We conducted a pilot study to investigate recruitment feasibility and assess whether effusion on ultrasound of the knee was associated with greater reduction in knee pain after corticosteroid injection. Methods: A pilot study was conducted from 2020 to 2021 including patients ≥40 years with knee OA undergoing clinically indicated corticosteroid injections. At baseline, participants completed the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale and had an ultrasound of the injected knee(s) to assess for effusion, defined as anechoic material in the suprapatellar recess. KOOS Pain was re-assessed two weeks following injection. We used mixed linear models to evaluate the change in KOOS Pain scores for knees with and without effusion to determine estimates of the magnitude of association. Results: We recruited 10 participants who contributed 16 knees from 4 clinical sessions. The mean age was 68 years (standard deviation [SD] 13) and 90% were female. Six knees had effusion. At baseline, knees without effusion had greater pain (mean KOOS Pain 44, SD 19) compared to those with effusion (mean KOOS Pain 51, SD 15). Knees without effusion had a 6 point (95% CI −16, 28) greater improvement in KOOS Pain 2-weeks post injection compared to those with effusion. Conclusion: This pilot study demonstrated clinic-based recruitment was feasible. We did not observe clinically important or statistically significant differences in pain relief post corticosteroid injection between knee OA patients with or without effusion.

Objective: To provide a framework for conducting clinical trial site visits virtually over videoconference, and to report on our experience doing so during the twelve-year follow-up of the Meniscal Tear in Osteoarthritis Research (MeTeOR) trial. Design: Using published FDA guidance and prior literature, we created a structure for virtual site visits that prioritized monitoring for protocol compliance, safety, and data integrity. We conducted site visits in three stages: preparation for the visit, the virtual meeting itself, and follow-up. The preparation phase involved a review of relevant site-specific documents and a written report on the findings prior to the visit. The virtual visit itself was focused on any questions the site staff had about the pre-visit report, observing a mock study visit, touring physical spaces, and understanding the site staff's work environment. In the follow-up phase, we wrote a post-visit report summarizing the discussion during the visit and feedback given by the coordinating site. Results: We found that the virtual site visits conducted as part of the MeTeOR trial follow-up ran smoothly. Although we could not directly compare in-person and virtual site visits, site staff unanimously appreciated the efficiency and effectiveness of the virtual site visits. We noted that displaying physical workspaces over videoconferencing was difficult, and a notable drawback to this method. Conclusions: To our knowledge, this is the first published framework for conducting virtual clinical trial site visits. Conducting these visits virtually confer several advantages in terms of time, money, and efficiency.

Abstract Background Knee osteoarthritis (OA) is among the most common and disabling persistent pain conditions, with increasing prevalence and impact around the globe. In the U.S., the rising prevalence of knee OA has been paralleled by an increase in annual rates of total knee arthroplasty (TKA), a surgical treatment option for late-stage knee OA. While TKA outcomes are generally good, post-operative trajectories of pain and functional status vary substantially; a significant minority of patients report ongoing pain and impaired function following TKA. A number of studies have identified sets of biopsychosocial risk factors for poor post-TKA outcomes (e.g., comorbidities, negative affect, sensory sensitivity), but few prospective studies have systematically evaluated the unique and combined influence of a broad array of factors. Methods This multi-site longitudinal cohort study investigated predictors of 6-month pain and functional outcomes following TKA. A wide spectrum of relevant biopsychosocial predictors was assessed preoperatively by medical history, patient-reported questionnaire, functional testing, and quantitative sensory testing in 248 patients undergoing TKA, and subsequently examined for their predictive capacity. Results The majority of patients had mild or no pain at 6 months, and minimal pain-related impairment, but approximately 30% reported pain intensity ratings of 3/10 or higher. Reporting greater pain severity and dysfunction at 6 months post-TKA was predicted by higher preoperative levels of negative affect, prior pain history, opioid use, and disrupted sleep. Interestingly, lower levels of resilience-related “positive” psychosocial characteristics (i.e., lower agreeableness, lower social support) were among the strongest, most consistent predictors of poor outcomes in multivariable linear regression models. Maladaptive profiles of pain modulation (e.g., elevated temporal summation of pain), while not robust unique predictors, interacted with psychosocial risk factors such that the TKA patients with the most pain and dysfunction exhibited lower resilience and enhanced temporal summation of pain. Conclusions This study underscores the importance of considering psychosocial (particularly positively-oriented resilience variables) and sensory profiles, as well as their interaction, in understanding post-surgical pain trajectories.

BackgroundThe impact of patient-specific psychosocial factors on functional outcomes after upper-extremity (UE) vascularized composite allotransplantation (VCA) is poorly understood. The objective of this study was to identify relevant psychosocial predictors for success or failure of UE VCA in an Austrian cohort.MethodsA qualitative study was undertaken consisting of semi-structured interviews with UE VCA staff, transplanted patients, and close relatives. Participants were asked about their perceptions of factors that either favored or hindered a successful transplant outcome, including functional status before surgery, preparation for transplant, decision-making, rehabilitation and functional outcome after surgery, and family and social support. Interviews were conducted online and recorded with the consent of interviewees.ResultsFour bilateral UE VCA patients, 7 healthcare professionals, and a sister of a patient participated in the study. Thematic analysis revealed the importance of an expert interdisciplinary team with adequate resources for patient selection. Psychosocial aspects of prospective candidates are crucial to evaluate as they contribute to success. Both patients and providers may be impacted by public perceptions of UE VCA. Functional outcomes are optimized with a life-long commitment to rehabilitation as well as close, ongoing provider involvement.ConclusionPsychosocial factors are important elements in the assessment and follow-up care for UE VCA. To best capture psychosocial elements of care, protocols must be individualized, patient-centered, and interdisciplinary. Investigating psychosocial predictors and collecting outcomes is, thus, critical to justifying UE VCA as a medical intervention and to providing accurate and salient information to prospective candidates.

Objective: Knee osteoarthritis (OA) can substantially limit function, which can be assessed both objectively and subjectively. We examined whether objective performance tests are associated with self-reported function. Methods: We analyzed baseline data from the Osteoarthritis Registry of Biomarker and Imaging Trajectories (ORBIT) of participants ≥40 years old with symptomatic and radiographic knee OA. Subjects completed the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain and Activities of Daily Living (ADL) scales and other assessments of pain and comorbidity. Subjects performed the timed single leg balance test (SLB), 30-s sit-to-stand (30s STS), Timed-Up-and-Go (TUG), and 40-m fast paced walk (40 ​m Walk). We used Pearson correlation coefficients to examine associations between performance and KOOS subscales. We adjusted for potential confounders using partial correlations. Results: We enrolled 101 subjects (mean age 63.7 (standard deviation (SD) 10.1), mean BMI 30.0 (SD 5.6), and 63% female). The mean (SD) values for the performance tests were: SLB 20.1 (18.9) seconds, 30s STS 11.7 (4.6) stands, TUG 9.4 (2.3) seconds, and 40 ​m Walk 27.6 (6.5) seconds. Correlations between performance tests and self-report measures did not exceed 0.39, with the absolute value of correlations between KOOS ADL and performance measures ranging from 0.24 to 0.39. Adjusted partial correlations were largely similar to the crude correlations. Conclusions: Self-reported function in persons with knee OA had weak to modest correlations with objective function. Objective performance tests capture elements of physical function that self-report data do not and point to the potential value of including objective measures of functional status in OA trials.

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.

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.

Abstract Background Early research suggests the COVID-19 pandemic worsened intimate partner violence (IPV) in the US. In particular, stay-at-home orders and social distancing kept survivors in close proximity to their abusers and restricted access to resources and care. We aimed to understand and characterize the impact of the pandemic on delivery of IPV care in Boston. Methods We conducted individual interviews with providers of IPV care and support in the Greater Boston area, including healthcare workers, social workers, lawyers, advocates, and housing specialists, who continued to work during the COVID-19 pandemic. Using thematic analysis, we identified themes describing the challenges and opportunites providers faced in caring for survivors during the pandemic. Results Analysis of 18 interviews yielded four thematic domains, encompassing 18 themes and nine sub-themes. Thematic analysis revealed that the pandemic posed an increased threat to survivors of IPV by exacerbating external stressors and leading to heightened violence. On a system level, the pandemic led to widespread uncertainty, strained resources, amplified inequities, and loss of community. On an individual level, COVID-19 restrictions limited survivors’ abilities to access resources and to be safe, and amplified pre-existing inequities, such as limited technology access. Those who did not speak English or were immigrants experienced even more difficulty accessing resources due to language and/or cultural barriers. To address these challenges, providers utilized video and telephone interactions, and stressed the importance of creativity and cooperation across different sectors of care. Conclusions While virtual care was essential in allowing providers to care for survivors, and also allowed for increased flexibility, it was not a panacea. Many survivors faced additional obstacles to care, such as language barriers, unequal access to technology, lack of childcare, and economic insecurity. Providers addressed these barriers by tailoring services and care modalities to an individual’s needs and circumstances. Going forward, some innovations of the pandemic period, such as virtual interactions and cooperation across care sectors, may be utilized in ways that attend to shifting survivor needs and access, thereby improving safe, equitable, and trauma-informed IPV care.

Background: The sacro-femoro-pubic (SFP) angle is a surrogate measurement for pelvic tilt obtained on anteroposterior (AP) pelvis radiographs. It is unknown whether the SFP angle can be measured reliably by senior surgeons and trainees alike. Methods: We conducted an intrareader and interreader reliability study using preoperative AP pelvis radiographs. Using our hospital electronic database, we randomly selected 31 subjects undergoing primary total hip arthroplasty. An attending orthopedic surgeon and two orthopedic surgery residents performed two separate SFP angle measurements for each subject. Intrareader and interreader agreement were measured using intraclass correlation coefficients (ICC). Results: Pairwise intrareader and interreader ICCs ranged from 0.91 to 0.99. Overall ICC was 0.94. Interreader ICCs between the attending surgeon and each orthopedic resident were 0.93 and 0.98, and the ICC between orthopedic residents was 0.91. Interreader mean differences for SFP angle measurements were 2.32 degrees or less: -2.03 (standard deviation: 2.23) and 0.29 (1.64) between the attending surgeon and each orthopedic resident, and 2.32 (2.44) between orthopedic residents. Conclusion: SFP angle may be measured reliably on AP pelvis radiographs by senior clinicians and trainees. SFP angle measurement may prove helpful as an alternative to pelvic tilt measurements when lateral pelvic radiographs are not available.

Abstract Background Despite the growing number of patients with limited English proficiency in the United States, not all medical schools offer medical language courses to train future physicians in practicing language-concordant care. Little is known about the long-term use of non-English languages among physicians who took language courses in medical school. We conducted a cross-sectional study to characterize the professional language use of Harvard Medical School (HMS) alumni who took a medical language course at HMS and identify opportunities to improve the HMS Medical Language Program. Methods Between October and November 2019, we sent an electronic survey to 803 HMS alumni who took a medical language course at HMS between 1991 and 2019 and collected responses. The survey had questions about the language courses and language use in the professional setting. We analyzed the data using descriptive statistics and McNemar’s test for comparing proportions with paired data. The study was determined not to constitute human subjects research. Results The response rate was 26% (206/803). More than half of respondents (n = 118, 57%) cited their desire to use the language in their future careers as the motivation for taking the language courses. Twenty-eight (14%) respondents indicated a change from not proficient before taking the course to proficient at the time of survey whereas only one (0.5%) respondent changed from proficient to not proficient (McNemar’s p-value

Abstract Background Mobile health clinics serve an important role in the health care system, providing care to some of the most vulnerable populations. Mobile Health Map is the only comprehensive database of mobile clinics in the United States. Members of this collaborative research network and learning community supply information about their location, services, target populations, and costs. They also have access to tools to measure, improve, and communicate their impact. Methods We analyzed data from 811 clinics that participated in Mobile Health Map between 2007 and 2017 to describe the demographics of the clients these clinics serve, the services they provide, and mobile clinics’ affiliated institutions and funding sources. Results Mobile clinics provide a median number of 3491 visits annually. More than half of their clients are women (55%) and racial/ethnic minorities (59%). Of the 146 clinics that reported insurance data, 41% of clients were uninsured while 44% had some form of public insurance. The most common service models were primary care (41%) and prevention (47%). With regards to organizational affiliations, they vary from independent (33%) to university affiliated (24%), while some (29%) are part of a hospital or health care system. Most mobile clinics receive some financial support from philanthropy (52%), while slightly less than half (45%) receive federal funds. Conclusion Mobile health care delivery is an innovative model of health services delivery that provides a wide variety of services to vulnerable populations. The clinics vary in service mix, patient demographics, and relationships with the fixed health system. Although access to care has increased in recent years through the Affordable Care Act, barriers continue to persist, particularly among populations living in resource-limited areas. Mobile clinics can improve access by serving as a vital link between the community and clinical facilities. Additional work is needed to advance availability of this important resource.

Objective Diet and exercise (D+E) for knee osteoarthritis (OA) is effective and cost‐effective. However, cost‐effectiveness does not imply affordability; the impact of knee OA–specific D+E programs on insurer budgets is unknown. Methods We estimated changes in undiscounted medical expenditures (2016 US dollars) with and without a D+E program. We accounted for both additional program outlays and potential savings from reduced use of other knee OA treatments and from reduced incidence of comorbidities. We adopted the perspective of a representative commercial insurance plan covering 200 000 individuals aged 25 to 64 years and a representative Medicare Advantage plan covering 200 000 Medicare‐eligible individuals aged 65 years and older. We used the Osteoarthritis Policy Model, a validated microsimulation model of knee OA, to model D+E efficacy (measured by pain and weight reduction), adherence, and price based on the Intensive Diet and Exercise for Arthritis (IDEA) trial. In sensitivity analyses, we varied time horizon, D+E efficacy, and D+E price. Results Over 3 years, the D+E program increased spending by $752 200 ($0.10 per member per month [PMPM]) in the commercial plan and by $6.0 million ($0.84 PMPM) in the Medicare plan. Over 3 years, the D+E program reduced opioid use by 6% and 5% and reduced total knee replacements by 5% and 4% in the commercial and Medicare plans, respectively. Expenses were higher in the Medicare plan because it had more patients with knee OA than the commercial plan. Conclusion Although there is no established threshold to define affordability, a D+E program for knee OA would likely produce expenditures comparable with outlays for other health‐promotion interventions.

Background: Total joint replacement recipients (TJR) are at risk for prosthetic joint infection (PJI), particularly those with comorbidities such as diabetes mellitus (DM) and rheumatoid arthritis (RA). Methods: We mailed surveys to 1078 subjects undergoing primary TJR between 2011 and 2016 ​at an academic center. The survey asked about medical, dental, and orthopedic history and use of antibiotics prior to dental appointments. We generated adjusted relative risks (aRR) for using antibiotic prophylaxis less than always using Poisson regression, adjusting for demographic, clinical, and behavioral factors. Results: We received surveys from 639 subjects; 597 were eligible and formed the analytical sample. 66 ​% reported always using antibiotic prophylaxis. DM and RA were not associated with prophylaxis use. Factors associated with less frequent use included: BMI ≥30 (aRR ​= ​1.27, 95 ​% CI [1.01, 1.60]), dental cleanings

Abstract Background and Aims Nursing home research may involve eliciting information from managers, yet response rates for Directors of Nursing have not been recently studied. As a part of a more extensive study, we surveyed all nursing homes in three states in 2018 and 2019, updating how to survey these leaders effectively. We focus on response rates as a measure of non‐response error and comparison of nursing home's characteristics to their population values as a measure of representation error. Methods We surveyed Directors of Nursing or their designees in nursing homes serving adult residents with at least 30 beds in California, Massachusetts, and Ohio (N = 2389). We collected contact information for respondents and then emailed survey invitations and links, followed by three email reminders and a paper version. Nursing home associations in two of the states contacted their members on our behalf. We compared the response rates across waves and states. We also compared the characteristics of nursing homes based on whether the response was via email or paper. In a multivariable logit regression, we used characteristics of the survey and the nursing homes to predict whether their DON responded to the survey using adjustments for multiple comparisons. Results The response rate was higher for the first wave than for the second (30% vs 20.5%). The highest response rate was in Massachusetts (31.8%), followed by Ohio (25.8%) and California (19.5%). Nursing home characteristics did not vary by response mode. Additionally, we did not find any statistically significant predictors of whether a nursing home responded. Conclusion A single‐mode survey may provide a reasonably representative sample at the cost of sample size. With that said, however, switching modes can increase sample size without potentially biasing the sample.

Objectives To validate and test the dimensionality of six constructs from the Workplace Integrated Safety and Health (WISH) assessment, an instrument that assesses the extent to which organisations implement integrated systems approaches for protecting and promoting worker health, safety and well-being, in a sample of nursing homes in the USA.Design Validation of an assessment scale using data from a cross-sectional survey.Setting Nursing homes certified by the Centers for Medicaid and Medicare services in three states of the USA: Ohio, California and Massachusetts.Participants 569 directors of nursing from nursing homes serving adults and with more than 30 beds participated in the study.Results Graded response Item Response Theory (IRT) models showed that five out of six constructs were unidimensional based on balanced interpretation of model fit statistics—M2 or C2 with p value >0.05, Comparative Fit Index >0.95, lower bound of the root mean squared error of approximation 90% CI

We provide a detailed account of the origin and establishment of the Osteoarthritis Research Society International (OARSI) and celebrate its history from inception to the current day. We discuss the mission, vision and strategic objectives of OARSI and how these have developed and evolved over the last 3 decades. We celebrate the achievements of the society as we approach its 30th birthday, honor the entire presidential line and respectfully pay tribute to the past presidents who are no longer with us. We reflect on the strong foundations of our society, OARSI’s efforts to disseminate understanding of the health, disability and economic burdens of osteoarthritis (OA) to policymakers, and the exciting initiatives to make the society inclusive and international. We thank our corporate and industrial sponsors, who have supported us over many years, without whom our annual congresses would not have been possible. We celebrate our longstanding strategic partnership with our publisher, Elsevier, and the successful launch of our new journal Osteoarthritis and Cartilage Open, the most significant new development in our dissemination toolbox. For the first time in the history of the organization, our annual congress was cancelled in April 2020 and the 2021 meeting will be virtual. Despite the numerous challenges posed by the ongoing COVID-19 pandemic and the need to adapt quickly to a rapidly changing landscape, we must remain optimistic about the future. We will take advantage of new exciting opportunities to advance our mission and vision to enhance the quality of life of persons with OA.

Abstract Background Knee osteoarthritis (OA) is prevalent and often associated with meniscal tear. Physical therapy (PT) and exercise regimens are often used to treat OA or meniscal tear, but, to date, few programs have been designed specifically for conservative treatment of meniscal tear with concomitant knee OA. Clinical care and research would be enhanced by a standardized, evidence–based, conservative treatment program and the ability to study the effects of the contextual factors associated with interventions for patients with painful, degenerative meniscal tears in the setting of OA. This paper describes the process of developing both a PT intervention and a home exercise program for a randomized controlled clinical trial that will compare the effectiveness of these interventions for patients with knee pain, meniscal tear and concomitant OA. Methods This paper describes the process utilized by an interdisciplinary team of physical therapists, physicians, and researchers to develop and refine a standardized in-clinic PT intervention, and a standardized home exercise program to be carried out without PT supervision. The process was guided in part by Medical Research Council guidance on intervention development. Results The investigators achieved agreement on an in-clinic PT intervention that included manual therapy, stretching, strengthening, and neuromuscular functional training addressing major impairments in range of motion, musculotendinous length, muscle strength and neuromotor control in the major muscle groups associated with improving knee function. The investigators additionally achieved agreement on a progressive, protocol-based home exercise program (HEP) that addressed the same major muscle groups. The HEP was designed to allow patients to perform and progress the exercises without PT supervision, utilizing minimal equipment and a variety of methods for instruction. Discussion This multi-faceted in-clinic PT program and standardized HEP provide templates for in-clinic and home-based care for patients with symptomatic degenerative meniscal tear and concomitant OA. These interventions will be tested as part of the Treatment of Meniscal Tear in Osteoarthritis (TeMPO) Trial. Trial registration The TeMPO Trial was first registered at clinicaltrials.gov with registration No. NCT03059004 on February 14, 2017. TeMPO was also approved by the Institutional Review Board at Partners HealthCare/Brigham and Women’s Hospital.

Objective Orthopedic literature on expectations is limited by lack of uniformity in how expectations are defined, conceptualized, and measured. Within this scoping review, we present a conceptual framework for understanding the construct of expectations and its derivatives (ie, expectation, expectancy, expectancies, etc) in studies of elective surgical orthopedic procedures. We also utilize this framework to map the current orthopedic surgery literature on expectations, highlighting its strengths, weaknesses, and gaps in its knowledge base. Methods We included articles that mentioned both expectations and one or more of 10 selected surgeries in their title or abstract. We focused on representative elective orthopedic surgeries that covered the body's major regions. We operationalized each study's individual expectation items into one of the expectation concept types within the presented conceptual model. We also extracted the name and type of expectations measurement tool used, whose expectations were measured, and descriptive information (eg, surgery type, publication date, country of origin, and study type). Results Ninety studies were included, with 70% published after 2008. A total of 64% investigated total knee and total hip arthroplasty, whereas 90% of studies investigated the expectations of patients, 5.6% investigated the expectations of physicians, and 4.4% investigated both. Of all studies, 72% utilized either study‐specific instruments with close‐ended, Likert‐type response formats or modifications of existing expectations questionnaires. Most studies focused on desirable, nontimeline‐related, treatment outcome expectations. Many studies aggregated multiple expectation results into a single score. Conclusion Adopting the standardized framework for expectations presented in this study will foster clearer communication and permit researchers to aggregate results across studies.

Objective The objective of this study was to measure cumulative incidence and incidence rate and identify factors associated with new musculoskeletal (MSK) symptomatic areas after total knee replacement (TKR) for osteoarthritis (OA). Methods Using data from a randomized controlled trial of patients undergoing elective TKR for OA, we assessed for MSK symptomatic areas by region (neck, hands/wrists/arms/shoulders, back, hips, nonindex knee, and ankles/feet) at baseline (pre‐TKR), and at 3, 6, 12, 24, 36, and 48 months post‐TKR. Cumulative incidence and incidence rates were calculated for each region. Factors associated with incident MSK symptomatic areas were identified using generalized linear mixed models. Time to incident symptomatic area was assessed using Cox proportional hazards regression. Results Among 293 subjects, the cumulative incidence of any new MSK symptomatic area over 4 years was 45%; the incidence rate was 19.2 per 100 person‐years. Body site–specific cumulative incidence and incidence rates were highest for nonindex knee and back. Predictors of incident MSK symptomatic areas included female sex (relative risk [RR] 1.64; 95% confidence interval [CI] 1.15‐2.34), body mass index of 35 or higher (RR 1.27; 95% CI 0.88‐1.85), Charlson Comorbidity Index 2 or more (RR 1.28; 95% CI 0.92‐1.78), baseline index knee Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score greater than 40 (RR 1.39; 95% CI 0.99‐1.95), and anxiety/depression (measured by the five‐item Mental Health Index) (RR 1.70; 95% CI 1.20‐2.40). Conclusion Incident MSK symptomatic areas occurred in roughly half of recipients of TKR in the 4 years after the operation. Further study is needed to examine the long‐term impact of MSK symptomatic areas on postoperative pain, function, and quality of life.

Objective Up to 30% of patients experience persistent pain and functional limitations following total knee replacement (TKR). Rapid symptom relief in the early postoperative period may be linked to longer‐term outcome improvements. We sought to identify early improvement trajectories and to identify risk factors for suboptimal outcomes. Methods We used data from the Adding Value in Knee Arthroplasty (AViKA) Cohort study, a prospective longitudinal study of patients with knee osteoarthritis who underwent TKR. We assessed pain and function using the Western Ontario and McMaster Universities Arthritis Index (WOMAC). We used group‐based trajectory modeling to identify distinct patterns of pain and function improvement over 6 months. We assessed the association between these early improvement trajectories and 24‐month outcomes, including pain, function, and satisfaction. Results We analyzed data from 107 subjects. Mean baseline WOMAC pain and function scores were 42 (SD 17) and 44 (SD 15), respectively (0‐100; 100 = worst). We identified two pain‐improvement trajectories (suboptimal vs optimal improvement) and two function‐improvement trajectories (suboptimal vs optimal improvement). Greater pain catastrophizing, worse mental health status, and use of a supportive device prior to TKR were associated with being in a suboptimal trajectory. Recipients of TKR in the suboptimal trajectories had higher pain, high functional disability, and lower satisfaction at 24 months post‐TKR. Conclusion Patients with slower improvement over the first 6 months post‐TKR had worse outcomes at 24 months, suggesting that this early postoperative period may represent a window during which interventions aimed at speeding recovery may improve long‐term TKR outcomes.

Abstract Medical research increasingly makes use of embodiment concepts to understand how illness disrupts unity of body and self. However, few have applied embodiment concepts in total joint replacement (TJR), an effective treatment for end‐stage arthritis. In considering why a troubling proportion of TJR recipients have continued pain and functional limitation, we ask: what role might be played by the embodied experience of living with an implant? Relevant theoretical models and prior research on embodiment in musculoskeletal health and transplantation are reviewed. Our findings suggest a research agenda with implications for addressing suboptimal outcomes in TJR.

Abstract Background Meniscal tears often accompany knee osteoarthritis, a disabling condition affecting 14 million individuals in the United States. While several randomized controlled trials have compared physical therapy to surgery for individuals with knee pain, meniscal tear, and osteoarthritic changes (determined via radiographs or magnetic resonance imaging), no trial has evaluated the efficacy of physical therapy alone in these subjects. Methods The Treatment of Meniscal Tear in Osteoarthritis (TeMPO) Trial is a four-arm multi-center randomized controlled clinical trial designed to establish the comparative efficacy of two in-clinic physical therapy interventions (one focused on strengthening and one containing placebo) and two protocolized home exercise programs. Discussion The goal of this paper is to present the rationale behind TeMPO and describe the study design and implementation strategies, focusing on methodologic and clinical challenges. Trial registration The TeMPO Trial was first registered at clinicaltrials.gov with registration No. NCT03059004. on February 14, 2017.

Objective: Type II diabetes mellitus (T2DM) is prevalent in knee osteoarthritis (OA) patients undergoing total knee arthroplasty (TKA) and increases risk for prosthetic joint infection (PJI). We examined the cost-effectiveness of antibiotic prophylaxis (AP) before dental procedures to reduce PJI in TKA recipients with T2DM. Design: We used the Osteoarthritis Policy Model, a validated computer simulation of knee OA, to compare two strategies among TKA recipients with T2DM (mean age 68 years, mean BMI 35.4 kg/m2): 1) AP before dental procedures and 2) no AP. Outcomes included quality-adjusted life expectancy (QALE) and lifetime medical costs. We used published efficacy of AP. We report incremental cost-effectiveness ratios (ICERs) and considered strategies with ICERs below well-accepted willingness-to-pay (WTP) thresholds cost-effective. We conducted sensitivity analyses to examine the robustness of findings to uncertainty in model input parameters. We used a lifetime horizon and healthcare sector perspective. Results: We found that AP added 1.0 quality-adjusted life-year (QALY) and $66,000 for every 1000 TKA recipients with T2DM, resulting in an ICER of $66,000/QALY. In sensitivity analyses, reduction of the probability of PJI, T2DM-associated risk of infection, or attribution of infections to dental procedures by 50% resulted in ICERs exceeding $100,000/QALY. Probabilistic sensitivity analyses showed that AP was cost-effective in 32% and 58% of scenarios at WTP of $50,000/QALY and $100,000/QALY, respectively. Conclusions: AP prior to dental procedures is cost-effective for TKA recipients with T2DM. However, the cost-effectiveness of AP depends on the risk of PJI and efficacy of AP in this population.

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.

Summary: Objective: Strengthening-based physical therapy (PT) is frequently recommended for persons with knee osteoarthritis (OA) and meniscal tear. On average, knee OA patients experience pain improvement while undergoing PT, but whether these changes are accompanied by changes in muscle strength remains an important research question. Design: We used data from subjects randomized to PT in the Meniscal Tear in Osteoarthritis Research (MeTeOR) trial. Key elements, measured at baseline and 3 months, included quadriceps and hamstrings strength (in pounds) and Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale (0–100; 100 worst). We examined the linear association between change in strength and change in pain over 3 months. Results: 111 subjects (mean age 57.1, average baseline hamstrings strength 27.5 (SD 14.7), average baseline KOOS 48.0 (SD 17.0)) experienced an average increase in hamstring strength of 3.5 lbs (SD 9.4) and an average decrease in KOOS Pain of 17.1 points (SD 17.4). The correlation between change in hamstrings strength and change in KOOS Pain was weak (Pearson r = 0.17; 95% CI-0.016–0.345). A multivariable linear regression model adjusting for baseline pain showed that a 10-pound increase in hamstrings strength was associated with a 2.9-point (95% CI−0.05−5.9) reduction in KOOS Pain. The association between changes in quadriceps strength and pain was even weaker than that for hamstrings pain. Conclusion: We observed small increases in strength and weak associations between strengthening and pain relief, suggesting that pain relief achieved during PT likely arises from multiple factors beyond strengthening alone.

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.

Summary: Objective: To summarize proceedings of a workshop convened to discuss advances in disease modifying osteoarthritis (OA) drugs and regulatory challenges in bringing these drugs to market. Design: Summary of a one day workshop held in Washington, DC in May 2019. Results: Attendees presented data documenting the prevalence, cost and disability burden of OA; recent documentation of disease modification without concomitant clinical benefit in trials of disease modifying drugs; regulatory considerations pertinent to disease modifying therapy; and methodologic approaches to addressing these regulatory considerations. Conclusions: The research, pharmaceutical and regulatory communities must continue to collaborate on defining pathways for approval of disease modifying osteoarthritis drugs that document effects on clinical endpoints (such as pain, function or joint replacement) as well as on bone, cartilage and other structures.

Summary: Objective: Symptoms resembling neuropathic pain (neuropathic-like symptoms) are prevalent in osteoarthritis (OA) populations. Scales that measure neuropathic-like symptoms frequently were established in groups with true neuropathic pain conditions and have not been assessed in OA. We assessed the psychometric properties of the Neuropathic Pain Scale (NPS) in subjects with OA undergoing total knee replacement (TKR). Design: In a prospective study of adults undergoing TKR for OA, we assessed baseline distributions, acceptability (completion rate), internal consistency (Cronbach's alpha), responsiveness 12 months post-TKR, and construct validity of the NPS. We performed factor analysis and created subscales from the items loading onto each retained factor. We evaluated subscale properties and calculated the proportion of total scores attributable to each subscale and compared this with the proportion expected if each item contributed equally. Results: Mean baseline NPS score among 263 participants was 42.7 (SD: 15.9). Cronbach's alpha was 0.88. Factor analysis produced two factors: “bothersome” (items: intense/sharp/dull/unpleasant/deep; Cronbach's alpha = 0.87), and “dysesthetic” (items: cold/sensitive/itchy/surface; alpha = 0.77). Bothersome items contributed more to total NPS scores (74%) than would be expected if each item contributed equally (50%). NPS scores correlated moderately with baseline pain and function, and decreased after TKR, with standardized response means (SRMs) of: total NPS: 1.77, Bothersome subscale: 2.03, Dysesthetic subscale: 0.70. Conclusions: The NPS had acceptable completion, internal consistency, and construct validity, but was not optimal for use in OA; Bothersome subscale items disproportionately drive total NPS scores and may fail to discriminate between nociceptive and neuropathic-like symptoms.

Abstract Background Iatrogenic injection injury is a major cause of disability in Ugandan children. Two injuries thought to result from injection of medications into the gluteal region include post-injection paralysis (PIP) and gluteal fibrosis (GF). This study aimed to describe perceptions of local health care workers regarding risk factors, particularly injections, for development of GF and PIP. Specifically, we examine the role of injection practices in the development of these injuries by interviewing a diverse cohort of individuals working in the health sector. Methods We conducted a qualitative study in the Kumi and Wakiso Districts of Uganda in November 2017, utilizing 68 key informant interviews with individuals working in healthcare related fields. Interviews were structured utilizing a moderator guide focusing on injection practices, gluteal fibrosis and post-injection paralysis. Results We identified six themes regarding perceptions of the cause of GF and PIP and organized these themes into a theoretical framework. There was a consensus among the individuals working in healthcare that inadequacies of the health care delivery system may lead to inappropriate intramuscular injection practices, which are presumed to contribute to the development of GF and PIP. Poor access to medications and qualified personnel has led to the proliferation of private clinics, which are often staffed by under-trained practitioners. Misaligned economic incentives and a lack of training may also motivate practitioners to administer frequent intramuscular injections, which cost more than oral medications. A lack of regulatory enforcement enables these practices to persist. However, due to limited community awareness, patients often perceive these practitioners as appropriately trained, and the patients frequently prefer injections over alternative treatment modalities. Conclusion This qualitative study suggests that inappropriate intramuscular injections, may arise from problems in the health care delivery system. To prevent the disability of GF and PIP, it is important to not only address the intramuscular injections practices in Uganda, but also to examine upstream deficits in access, education, and policy enforcement.

Abstract Background The purpose of this study was to estimate the prevalence of postinjection paralysis (PIP) and gluteal fibrosis (GF) among children treated in a rural Ugandan Hospital. Methods We conducted a retrospective cohort study by reviewing the musculoskeletal clinic and community outreach logs for children (age

Abstract Background Sufficient lower extremity muscle strength is necessary for performing functional tasks, and individuals with knee osteoarthritis demonstrate thigh muscle weakness compared to controls. It has been suggested that lower muscle strength is associated with a variety of clinical features including pain, mobility, and functional performance, yet these relationships have not been fully explored in patients with symptomatic meniscal tear in addition to knee osteoarthritis. Our purpose was to evaluate the associations of quadriceps and hamstrings muscle strength with structural damage and clinical features in individuals with knee osteoarthritis and symptomatic meniscal tear. Methods We performed a cross-sectional study using baseline data from the Meniscal Tear in Osteoarthritis Research (MeTeOR) trial. We assessed structural damage using Kellgren-Lawrence grade and the magnetic resonance imaging osteoarthritis knee score (MOAKS) for cartilage damage. We used the Knee Injury and Osteoarthritis Outcomes Score (KOOS) to evaluate pain, symptoms, and activities of daily living (ADL), and the Timed Up and Go (TUG) test to assess mobility. We assessed quadriceps and hamstrings strength using a hand-held dynamometer and classified each into quartiles (Q). We used Chi square tests to evaluate the association between strength and structural damage; and separate analysis of covariance models to establish the association between pain, symptoms, ADL and mobility with strength, after adjusting for demographic characteristics (age, sex and BMI) and structural damage. Results Two hundred fifty two participants were evaluated. For quadriceps strength, subjects in the strongest quartile scored 14 and 13 points higher on the KOOS Pain and ADL subscales, respectively, and completed the TUG two seconds faster than subjects in the weakest quartile. For hamstrings strength, subjects in the strongest quartile scored 13 and 14 points higher on the KOOS pain and ADL subscales, respectively, and completed the TUG two seconds faster than subjects in the weakest quartile. Strength was not associated with structural damage. Conclusions Greater quadriceps and hamstrings muscle strength was associated with less pain, less difficulty completing activities of daily living, and better mobility. These relationships should be evaluated longitudinally.

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

Abstract Background 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].

Background: 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

Abstract Background Arthroscopic surgery is a common treatment for knee osteoarthritis (OA), particularly for symptomatic meniscal tear. Many patients with knee OA who have arthroscopies go on to have total knee arthroplasty (TKA). Several individual studies have investigated the interval between knee arthroscopy and TKA. Our objective was to summarize published literature on the risk of TKA following knee arthroscopy, the duration between arthroscopy and TKA, and risk factors for TKA following knee arthroscopy. Methods We searched PubMed, Embase, and Web of Science for English language manuscripts reporting TKA following arthroscopy for knee OA. We identified 511 manuscripts, of which 20 met the inclusion criteria and were used for analysis. We compared the cumulative incidence of TKA following arthroscopy in each study arm, stratifying by type of data source (registry vs. clinical), and whether the study was limited to older patients (≥ 50) or those with more severe radiographic OA. We estimated cumulative incidence of TKA following arthroscopy by dividing the number of TKAs among persons who underwent arthroscopy by the number of persons who underwent arthroscopy. Annual incidence was calculated by dividing cumulative incidence by the mean years of follow-up. Results Overall, the annual incidence of TKA after arthroscopic surgery for OA was 2.62% (95% CI 1.73–3.51%). We calculated the annual incidence of TKA following arthroscopy in four separate groups defined by data source (registry vs. clinical cohort) and whether the sample was selected for disease progression (either age or OA severity). In unselected registry studies the annual TKA incidence was 1.99% (95% CI 1.03–2.96%), compared to 3.89% (95% CI 0.69–7.09%) in registry studies of older patients. In unselected clinical cohorts the annual incidence was 2.02% (95% CI 0.67–3.36%), while in clinical cohorts with more severe OA the annual incidence was 4.13% (95% CI 1.81–6.44%). The mean and median duration between arthroscopy and TKA (years) were 3.4 and 2.0 years. Conclusions Clinicians and patients considering knee arthroscopy should discuss the likelihood of subsequent TKA as they weigh risks and benefits of surgery. Patients who are older or have more severe OA are at particularly high risk of TKA.

Abstract Background Studies of the epidemiology and outcomes of avascular necrosis (AVN) require accurate case-finding methods. The aim of this study was to evaluate performance characteristics of a claims-based algorithm designed to identify AVN cases in administrative data. Methods Using a centralized patient registry from a US academic medical center, we identified all adults aged ≥18 years who underwent magnetic resonance imaging (MRI) of an upper/lower extremity joint during the 1.5 year study period. A radiologist report confirming AVN on MRI served as the gold standard. We examined the sensitivity, specificity, positive predictive value (PPV) and positive likelihood ratio (LR+) of four algorithms (A-D) using International Classification of Diseases, 9th edition (ICD-9) codes for AVN. The algorithms ranged from least stringent (Algorithm A, requiring ≥1 ICD-9 code for AVN [733.4X]) to most stringent (Algorithm D, requiring ≥3 ICD-9 codes, each at least 30 days apart). Results Among 8200 patients who underwent MRI, 83 (1.0% [95% CI 0.78–1.22]) had AVN by gold standard. Algorithm A yielded the highest sensitivity (81.9%, 95% CI 72.0–89.5), with PPV of 66.0% (95% CI 56.0–75.1). The PPV of algorithm D increased to 82.2% (95% CI 67.9–92.0), although sensitivity decreased to 44.6% (95% CI 33.7–55.9). All four algorithms had specificities >99%. Conclusion An algorithm that uses a single billing code to screen for AVN among those who had MRI has the highest sensitivity and is best suited for studies in which further medical record review confirming AVN is feasible. Algorithms using multiple billing codes are recommended for use in administrative databases when further AVN validation is not feasible.