Identifying low acuity Emergency Department visits with a machine learning approach: The low acuity visit algorithms (LAVA).

OBJECTIVE: To improve the performance of International Classification of Disease (ICD) code rule-based algorithms for identifying low acuity Emergency Department (ED) visits by using machine learning methods and additional covariates. DATA SOURCES: We used secondary data on ED visits from the National Hospital Ambulatory Medical Survey (NHAMCS), from 2016 to 2020. STUDY DESIGN: We established baseline performance metrics with seven published algorithms consisting of International Classification of Disease, Tenth Revision codes used to identify low acuity ED visits. We then trained logistic regression, random forest, and gradient boosting (XGBoost) models to predict low acuity ED visits. Each model was trained on five different covariate sets of demographic and clinical data. Model performance was compared using a separate validation dataset. The primary performance metric was the probability that a visit identified by an algorithm as low acuity did not experience significant testing, treatment, or disposition (positive predictive value, PPV). Subgroup analyses assessed model performance across age, sex, and race/ethnicity. DATA COLLECTION: We used 2016-2019 NHAMCS data as the training set and 2020 NHAMCS data for validation. PRINCIPAL FINDINGS: The training and validation data consisted of 53,074 and 9542 observations, respectively. Among seven rule-based algorithms, the highest-performing had a PPV of 0.35 (95% CI [0.33, 0.36]). All model-based algorithms outperformed existing algorithms, with the least effective-random forest using only age and sex-improving PPV by 26% (up to 0.44; 95% CI [0.40, 0.48]). Logistic regression and XGBoost trained on all variables improved PPV by 83% (to 0.64; 95% CI [0.62, 0.66]). Multivariable models also demonstrated higher PPV across all three demographic subgroups. CONCLUSIONS: Machine learning models substantially outperform existing algorithms based on ICD codes in predicting low acuity ED visits. Variations in model performance across demographic groups highlight the need for further research to ensure their applicability and fairness across diverse populations.

Health Care Use Among Patients Retroactively Insured via a Hospital-Based Insurance Linkage Program.

OBJECTIVE: Over 25% of the 27 million uninsured individuals in the United States are eligible for Medicaid. Many hospitals have insurance linkage programs that assist eligible patients with enrollment, but little is known about the impact of these programs on care utilization. This research assessed health care utilization and health outcomes among patients enrolled in Medicaid via a hospital-based insurance linkage program. METHODS: This retrospective cohort study included adults aged 18-64 admitted to the hospital from 2016 to 2021. Those who obtained insurance retroactively via insurance linkage (RI) were compared with those who presented with Medicaid (MI) or remained uninsured (UI). The primary outcome was the presence of at least one visit with a primary care provider (PCP) in the 12 months following index admission. Secondary outcomes included having an assigned PCP, ED revisits, and hospital readmissions. For patients with diabetes and hypertension, 12-month hemoglobin A1c (HbA1c) and blood pressure (BP) readings were tracked. RESULTS: Of 3882 patients admitted with no insurance, 2905 (74.8%) were enrolled in insurance (RI). In multivariable analysis, RI patients were 14% more likely (OR 1.14, p = 0.020) to have completed at least one PCP visit by 12 months after index admission compared to those with preexisting Medicaid (MI), and uninsured patients were 29% less likely (OR 0.71, p = 0.003). MI and RI patients also had more ED revisits (p < 0.001) and greater 12-month reductions in blood pressure (p < 0.001) compared with uninsured patients. CONCLUSION: Hospital-based insurance linkage reached three-quarters of uninsured patients and was associated with increased utilization of acute and outpatient health care services. An acute care encounter represents an opportunity to connect patients to insurance, a key step toward improving their health outcomes.

Incorporation and Utilization of an Additional Needs Screener by Surgical Trainees for Comprehensive Care of Underserved and Underinsured Surgical Patients.

OBJECTIVE: Comprehensive, socially-minded healthcare has historically been delivered in the primary care setting. For underserved patient populations, however, a surgical care episode may serve as the health care access point. To maximize patient wellbeing during the perioperative period, our surgical center developed the Additional Needs Screener (ANS). Operationalized into practice by GME and UME trainees, this tool screens surgical patients across 3 domains (social, emotional, and immigration needs) and connects patients to partner organizations if appropriate. This study describes the pilot utilization of the ANS among underserved and underinsured surgical patients. DESIGN: Clinical quality improvement and retrospective cohort study of patients completing the ANS from implementation in September 2021 to September 2022. SETTING: The Hospital of the University of Pennsylvania, PA-a tertiary care center. PARTICIPANTS: One hundred and 10 underinsured and/or underserved patients completed at least 1 ANS domain. RESULTS: Patients were majority female (55F, 53M, 2 other) and Hispanic/Latinx (72%) with a median age of 38 (IQR = 34-48). Most patients spoke a primary language other than English (77%), and nearly all were either uninsured (82%) or received emergency medical assistance or Medicaid (14%) at referral. Patients demonstrated significant needs; 39% endorsed difficulty affording housing, 32% endorsed difficulty paying for food, 29% endorsed experiencing current life-interfering distress, and 75% had undocumented immigration status. Ultimately, 57% of screened patients accepted referrals to our needs response teams. CONCLUSIONS: Underserved and underinsured patients presenting for surgical care face significant challenges relating to social, emotional, and immigration needs. Through adoption of the ANS, trainees gained competency identifying and addressing these barriers in the perioperative period. Future works will focus on categorizing referral outcomes, developing interventions to increase patient trust, and improving screener dissemination.

Algorithms identifying low-acuity emergency department visits: A review and validation study.

OBJECTIVE: To characterize and validate the landscape of algorithms that use International Classification of Disease (ICD) codes to identify low-acuity emergency department (ED) visits. DATA SOURCES: Publicly available ED data from the National Hospital Ambulatory Medical Care Survey (NHAMCS). STUDY DESIGN: We systematically searched for studies that specify algorithms consisting of ICD codes that identify preventable or low-acuity ED visits. We classified ED visits in NHAMCS according to these algorithms and compared agreements using the Jaccard index. We then evaluated the performance of each algorithm using positive predictive value (PPV) and sensitivity, with the reference group specified using low-acuity composite (LAC) criteria consisting of both triage and clinical components. In sensitivity analyses, we repeated our primary analysis using only triage or only clinical criteria for reference. DATA COLLECTION: We used the 2011-2017 NHAMCS data, totaling 163,576 observations before survey weighting and after dropping observations missing a primary diagnosis. We translated ICD-9 codes (years 2011-2015) to ICD-10 using a standard crosswalk. PRINCIPAL FINDINGS: We identified 15 papers with an original list of ICD codes used to identify preventable or low-acuity ED presentations. These papers were published between 1992 and 2020, cited an average of 310 (SD 360) times, and included 968 (SD 1175) codes. Pairwise Jaccard similarity indices (0 = no overlap, 1 = perfect congruence) ranged from 0.01 to 0.82, with mean 0.20 (SD 0.13). When validated against the LAC reference group, the algorithms had an average PPV of 0.308 (95% CI [0.253, 0.364]) and sensitivity of 0.183 (95% CI [0.111, 0.256]). Overall, 2.1% of visits identified as low acuity by the algorithms died prehospital or in the ED, or needed surgery, critical care, or cardiac catheterization. CONCLUSIONS: Existing algorithms that identify low-acuity ED visits lack congruence and are imperfect predictors of visit acuity.

Telemedicine catches on: changes in the utilization of telemedicine services during the COVID-19 pandemic.

OBJECTIVES: To determine the degree of telemedicine expansion overall and across patient subpopulations and diagnoses. We hypothesized that telemedicine visits would increase substantially due to the need for continuity of care despite the disruptive effects of COVID-19. STUDY DESIGN: A retrospective study of health insurance claims for telemedicine visits from January 1, 2018, through March 10, 2020 (prepandemic period), and March 11, 2020, through October 31, 2020 (pandemic period). METHODS: We analyzed claims from 1,589,777 telemedicine visits that were submitted to Independence Blue Cross (Independence) from telemedicine-only providers and providers who traditionally deliver care in person. The primary exposure was the combination of individual behavior changes, state stay-at-home orders, and the Independence expansion of billing policies for telemedicine. The comparison population consisted of telemedicine visits in the prepandemic period. RESULTS: Telemedicine increased rapidly from a mean (SD) of 773 (155) weekly visits in prepandemic 2020 to 45,632 (19,937) weekly visits in the pandemic period. During the pandemic period, a greater proportion of telemedicine users were older, had Medicare Advantage insurance plans, had existing chronic conditions, or resided in predominantly non-Hispanic Black or African American Census tracts compared with during the prepandemic period. A significant increase in telemedicine claims containing a mental health-related diagnosis was observed. CONCLUSIONS: Telemedicine expanded rapidly during the COVID-19 pandemic across a broad range of clinical conditions and demographics. Although levels declined later in 2020, telemedicine utilization remained markedly higher than 2019 and 2018 levels. Trends suggest that telemedicine will likely play a key role in postpandemic care delivery.

Evaluation and disposition of older adults presenting to the emergency department with abdominal pain.

BACKGROUND: Abdominal pain is the most common chief complaint in US emergency departments (EDs) among patients over 65, who are at high risk of mortality or incident disability after the ED encounter. We sought to characterize the evaluation, management, and disposition of older adults who present to the ED with abdominal pain. METHODS: We performed a survey-weighted analysis of the National Hospital Ambulatory Medical Care Survey (NHAMCS), comparing older adults with a chief complaint of abdominal pain to those without. Visits from 2013 to 2017 to nationally representative EDs were included. We analyzed 81,509 visits to 1211 US EDs, which projects to 531,780,629 ED visits after survey weighting. We report the diagnostic testing, evaluation, management, additional reasons for visit, and disposition of ED visits. RESULTS: Among older adults (≥65 years), 7% of ED visits were for abdominal pain. Older patients with abdominal pain had a lower probability of being triaged to the "Emergent" (ESI2) acuity on arrival (7.1% vs. 14.8%) yet were more likely to be admitted directly to the operating room than older adults without abdominal pain (3.6% vs. 0.8%), with no statistically significant differences in discharge home, death, or admission to critical care. Ultrasound or CT imaging was performed in 60% of older adults with abdominal pain. A minority (39%) of older patients with abdominal pain received an electrocardiogram (EKG). CONCLUSIONS: Abdominal pain in older adults presenting to EDs is a serious condition yet is triaged to "emergent" acuity at half the rate of other conditions. Opportunities for improving diagnosis and management may exist. Further research is needed to examine whether improved recognition of abdominal pain as a syndromic presentation would improve patient outcomes.

The impact of the non-essential business closure policy on Covid-19 infection rates.

In response to the Covid-19 pandemic, many localities instituted non-essential business closure orders, keeping individuals categorized as essential workers at the frontlines while sending their non-essential counterparts home. We examine the extent to which being designated as an essential or non-essential worker impacts one's risk of being Covid-positive following the non-essential business closure order in Pennsylvania. We also assess the intrahousehold transmission risk experienced by their cohabiting family members and roommates. Using a difference-in-differences framework, we estimate that workers designated as essential have a 55% higher likelihood of being positive for Covid-19 than those classified as non-essential; in other words, non-essential workers experience a protective effect. While members of the health care and social assistance subsector contribute significantly to this overall effect, it is not completely driven by them. We also find evidence of intrahousehold transmission that differs in intensity by essential status. Dependents cohabiting with an essential worker have a 17% higher likelihood of being Covid-positive compared to those cohabiting with a non-essential worker. Roommates cohabiting with an essential worker experience a 38% increase in likelihood of being Covid-positive. Analysis of households with a Covid-positive member suggests that intrahousehold transmission is an important mechanism driving these effects.

The Value of Total Knee Replacement in Patients With Knee Osteoarthritis and a Body Mass Index of 40 kg/m2 or Greater : A Cost-Effectiveness Analysis.

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/m2 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/m2 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/m2 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/m2 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/m2 or greater, resulting in an ICER of $35 200. Total knee replacement in patients older than 65 years with a BMI of 40 kg/m2 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/m2 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/m2 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.

Characteristics of Nursing Homes by COVID-19 Cases Among Staff: March to August 2020.

OBJECTIVE: To measure the association between nursing home (NH) characteristics and Coronavirus Disease 2019 (COVID-19) prevalence among NH staff. DESIGN: Retrospective cross-sectional study. SETTING AND PARTICIPANTS: Centers for Disease Control and Prevention COVID-19 database for US NHs between March and August 2020, linked to NH facility characteristics (LTCFocus database) and local COVID-19 prevalence (USA Facts). METHODS: We estimated the associations between NH characteristics, local infection rates, and other regional characteristics and COVID-19 cases among NH staff (nursing staff, clinical staff, aides, and other facility personnel) measured per 100 beds, controlling for the hospital referral regions in which NHs were located to account for local infection control practices and other unobserved characteristics. RESULTS: Of the 11,858 NHs in our sample, 78.6% reported at least 1 staff case of COVID-19. After accounting for local COVID-19 prevalence, NHs in the highest quartile of confirmed resident cases (413.5 to 920.0 cases per 1000 residents) reported 18.9 more staff cases per 100 beds compared with NHs that had no resident cases. Large NHs (150 or more beds) reported 2.6 fewer staff cases per 100 beds compared with small NHs (<50 beds) and for-profit NHs reported 0.8 fewer staff cases per 100 beds compared with nonprofit NHs. Higher occupancy and more direct-care hours per day were associated with more staff cases (0.4 more cases per 100 beds for a 10% increase in occupancy, and 0.7 more cases per 100 beds for an increase in direct-care staffing of 1 hour per resident day, respectively). Estimates associated with resident demographics, payer mix, or regional socioeconomic characteristics were not statistically significant. CONCLUSIONS AND IMPLICATIONS: These findings highlight the urgent need to support facilities with emergency resources such as back-up staff and protocols to reduce resident density within the facility, which may help stem outbreaks.

Disruptions in preventive care: Mammograms during the COVID-19 pandemic.

OBJECTIVE: To measure the extent to which the provision of mammograms was impacted by the COVID-19 pandemic and surrounding guidelines. DATA SOURCES: De-identified summary data derived from medical claims and eligibility files were provided by Independence Blue Cross for women receiving mammograms. STUDY DESIGN: We used a difference-in-differences approach to characterize the change in mammograms performed over time and a queueing formula to estimate the time to clear the queue of missed mammograms. DATA COLLECTION: We used data from the first 30 weeks of each year from 2018 to 2020. PRINCIPAL FINDINGS: Over the 20 weeks following March 11, 2020, the volume of screening mammograms and diagnostic mammograms fell by 58% and 38% of expected levels, on average. Lowest volumes were observed in week 15 (April 8 to 14), when screening and diagnostic mammograms fell by 99% and 74%, respectively. Volumes began to rebound in week 19 (May), with diagnostic mammograms reaching levels to similar to previous years' and screening mammograms remaining 14% below expectations. We estimate it will take a minimum of 22 weeks to clear the queue of missed mammograms in our study sample. CONCLUSIONS: The provision of mammograms has been significantly disrupted due to the COVID-19 pandemic.

Long-Term Care, Residential Facilities, and COVID-19: An Overview of Federal and State Policy Responses.

The COVID-19 pandemic has disproportionately affected residents and staff at long-term care (LTC) and other residential facilities in the United States. The high morbidity and mortality at these facilities has been attributed to a combination of a particularly vulnerable population and a lack of resources to mitigate the risk. During the first wave of the pandemic, the federal and state governments received urgent calls for help from LTC and residential care facilities; between March and early June of 2020, policymakers responded with dozens of regulatory and policy changes. In this article, we provide an overview of these responses by first summarizing federal regulatory changes and then reviewing state-level executive orders. The policy and regulatory changes implemented at the federal and state levels can be categorized into the following 4 classes: (1) preventing virus transmission, which includes policies relating to visitation restrictions, personal protective equipment guidance, and testing requirements; (2) expanding facilities' capacities, which includes both the expansion of physical space for isolation purposes and the expansion of workforce to combat COVID-19; (3) relaxing administrative requirements, which includes measures enacted to shift the attention of caretakers and administrators from administrative requirements to residents' care; and (4) reporting COVID-19 data, which includes the reporting of cases and deaths to residents, families, and administrative bodies (such as state health departments). These policies represent a snapshot of the initial efforts to mitigate damage inflicted by the pandemic. Looking ahead, empirical evaluation of the consequences of these policies-including potential unintended effects-is urgently needed. The recent availability of publicly reported COVID-19 LTC data can be used to inform the development of evidence-based regulations, though there are concerns of reporting inaccuracies. Importantly, these data should also be used to systematically identify hot spots and help direct resources to struggling facilities.

Budget Impact of Funding an Intensive Diet and Exercise Program for Overweight and Obese Patients With Knee Osteoarthritis.

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.

Patient experiences of decision-making in the treatment of spinal metastases: a qualitative study.

BACKGROUND: In the treatment of spinal metastases the risks of surgery must be balanced against potential benefits, particularly in light of limited life-expectancy. Patient experiences and preferences regarding decision-making in this context are not well explored. PURPOSE: We performed a qualitative study involving patients receiving treatment for spinal metastatic disease. We sought to understand factors that influenced decision-making around care for spinal metastases. STUDY SETTING: Three tertiary academic medical centers. PATIENT SAMPLE: We recruited patients presenting for treatment of spinal metastatic disease at one of three tertiary centers in Boston, MA. OUTCOME MEASURES: We conducted semistructured interviews using a guide that probed participants' experiences with making treatment decisions. METHODS: We performed a thematic analysis that produced a list of themes, subthemes, and statement explaining how the themes related to the study's guiding questions. Patients were recruited until thematic saturation was reached. RESULTS: We interviewed 23 participants before reaching thematic saturation. The enormity of treatment decisions, and of the diagnosis of spinal metastases itself, shaped participant preferences for who should take responsibility for the decision and whether to accept treatments bearing greater risk of complications. Pre-existing participant beliefs about decision-making and about surgery interacted with the clinical context in a way that tended to promote accepting physician recommendations and delaying or avoiding surgery. CONCLUSIONS: The diagnosis of spinal metastatic disease played an outsized role in shaping participant preferences for agency in treatment decision-making. Further research should address strategies to support patient understanding of treatment options in clinical contexts-such as spinal metastases-characterized by ominous underlying disease and high-risk, often urgent interventions.

10 years of health-care reform in China: progress and gaps in Universal Health Coverage.

In 2009, China launched a major health-care reform and pledged to provide all citizens with equal access to basic health care with reasonable quality and financial risk protection. The government has since quadrupled its funding for health. The reform's first phase (2009-11) emphasised expanding social health insurance coverage for all and strengthening infrastructure. The second phase (2012 onwards) prioritised reforming its health-care delivery system through: (1) systemic reform of public hospitals by removing mark-up for drug sales, adjusting fee schedules, and reforming provider payment and governance structures; and (2) overhaul of its hospital-centric and treatment-based delivery system. In the past 10 years, China has made substantial progress in improving equal access to care and enhancing financial protection, especially for people of a lower socioeconomic status. However, gaps remain in quality of care, control of non-communicable diseases (NCDs), efficiency in delivery, control of health expenditures, and public satisfaction. To meet the needs of China's ageing population that is facing an increased NCD burden, we recommend leveraging strategic purchasing, information technology, and local pilots to build a primary health-care (PHC)-based integrated delivery system by aligning the incentives and governance of hospitals and PHC systems, improving the quality of PHC providers, and educating the public on the value of prevention and health maintenance.

Ambulatory status after surgical and nonsurgical treatment for spinal metastasis.

BACKGROUND: Decisions for operative or nonoperative management remain challenging for patients with spinal metastases, especially when life expectancy and quality of life are not easily predicted. This study evaluated the effects of operative and nonoperative management on maintenance of ambulatory function and survival for patients treated for spinal metastases. METHODS: Propensity matching was used to yield an analytic sample in which operatively and nonoperatively treated patients were similar with respect to key baseline covariates. The study included patients treated for spinal metastases between 2005 and 2017 who were 40 to 80 years old, were independent ambulators at presentation, and had fewer than 5 medical comorbidities. It evaluated the influence of operative care and nonoperative care on ambulatory function 6 months after presentation as the primary outcome. Survival at 6 months and survival at 1 year were secondary outcomes. RESULTS: Nine hundred twenty-nine individuals eligible for inclusion were identified, with 402 (201 operative patients and 201 nonoperative patients) retained after propensity score matching. Patients treated operatively had a lower likelihood than those treated nonoperatively of being nonambulatory 6 months after presentation (3% vs 16%; relative risk [RR], 0.16; 95% confidence interval [CI], 0.06-0.46) as well as a reduced risk of 6-month mortality (20% vs 29%; RR, 0.69; 95% CI, 0.49-0.98). CONCLUSIONS: These results indicate that in a group of patients with similar demographic and clinical characteristics, those treated operatively were less likely to lose ambulatory function 6 months after presentation than those managed nonoperatively. For patients with spinal metastases, our data can be incorporated into discussions about the treatments that align best with patients' preferences regarding surgical risk, mortality, and ambulatory status.

The TeMPO trial (treatment of meniscal tears in osteoarthritis): rationale and design features for a four arm randomized controlled clinical trial.

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.