Low Rates of Reporting Race, Ethnicity, and Socioeconomic Status in Studies Published in Top Orthopaedic Journals.

BACKGROUND: Although there have been calls for the routine reporting of patient demographics associated with health disparities, including race, ethnicity, and socioeconomic status (SES), in published research, the extent to which these variables are reported in orthopaedic journals remains unclear. METHODS: We identified and examined all research articles with human cohorts published in 2019 in the 2 highest-ranked U.S. general orthopaedics journals, Clinical Orthopaedics and Related Research and The Journal of Bone & Joint Surgery. Excluded from analysis were studies with no U.S.-based institution and those that did not report any demographic data. Articles were reviewed to determine study type; reporting of race, ethnicity, and any of 3 SES variables (i.e., income, education, and health-care insurance); and the inclusion of these demographics in multivariable analyses. RESULTS: A total of 156 articles met the inclusion criteria. Of these, 56 (35.9%) reported patient race and 24 (15.4%) reported patient ethnicity. Income was reported in 13 (8.3%) of the articles, education in 23 (14.7%), and health insurance in 18 (11.5%). Of the 97 papers that reported results of multivariable analyses, 30 (30.9%) included race in the analysis and 21 (21.6%) reported significance associated with race. Income, education, and health insurance were included in multivariable analyses in 7 (7.2%), 11 (11.3%), and 10 (10.3%) of the articles, respectively. CONCLUSIONS: Race, ethnicity, and SES were infrequently reported and analyzed within articles published in 2 of the top orthopaedic journals. This problem may be remedied if orthopaedic journals impose standards for the reporting and analysis of patient demographics in studies with human cohorts. CLINICAL RELEVANCE: Failure to report key demographics makes it difficult for practitioners to determine whether study results apply to their patient populations. In addition, when orthopaedic interventions are evaluated without accounting for potential disparities by demographics, clinicians may incorrectly assume that the overall benefits and risks reported in studies apply equally to all patients.

Dramatic Reduction in Opioid Prescribing for Common Outpatient Orthopaedic Lower Extremity Surgical Procedures at a Louisiana University-Based Safety-Net Hospital After Enactment of Opioid-Limiting State Legislation.

INTRODUCTION: The opioid epidemic in the United States has been fueled by overprescribing opioids, which is particularly apparent in orthopaedics. Stakeholders, including state legislatures, have attempted to curb opioid overprescribing to reduce related abuse/dependence, overdose deaths, and diversion. OBJECTIVE: To examine trends in opioid prescribing for common outpatient lower extremity orthopaedic surgeries in a population vulnerable to prolonged opioid use before and after the enactment of a 2017 Louisiana state law limiting opioid prescribing for acute pain. METHODS: Eligible patients were adults who underwent one of the five most common outpatient lower extremity orthopaedic surgeries done during 2013 to 2018 at an urban tertiary care academic medical center. Excluded were prisoners and patients who required inpatient hospitalization, had no documented discharge opioid prescription, or filled an opioid prescription unrelated to their orthopaedic procedure within 30 days before surgery. RESULTS: During 2013 to 2018, 655 surgical procedures were done in 655 eligible patients, of whom 49% were Black and 54% were insured by Medicaid. The mean morphine milligram equivalent per discharge prescription decreased by almost 70% from 2014 to 2018. A statistically significant decrease in the mean morphine milligram equivalent per discharge prescription was observed in 2018 versus all previous years (P < 0.0001 for all) and in 2017 versus all previous years (P < 0.0001 for all). Patients receiving at least one new opioid prescription after their discharge prescription declined over time from a high of 50% in 2013 to a low of 19.3% in 2018 with a statistically significant effect over time (P < 0.0001). DISCUSSION: Opioid prescribing for patients undergoing common outpatient lower extremity orthopaedic surgeries who were at high risk for prolonged opioid use markedly declined after the enactment of a state law limiting first-time opioid prescriptions to 7 days, requiring physicians to check the state's Prescription Monitoring Program database and mandating continuing education for opioid prescribers.

Rapid Versus Standard Recovery Protocol Is Associated With Improved Recovery of Range of Motion 12 Weeks After Total Knee Arthroplasty.

INTRODUCTION: With the increasing demand for total knee arthroplasty (TKA), rapid recovery protocols (RRPs) have been introduced to reduce costs and the length of stay (LOS). Little is known about the effects of RRPs on postoperative knee range of motion (ROM). METHODS: We reviewed the medical charts of 323 patients who underwent primary TKA performed by a single orthopaedic surgeon at a university-based orthopaedic tertiary care safety net practice. Of the 323 patients, 129 were treated with a standard recovery protocol (SRP) between January 1, 2012, and December 10, 2013, and 194 with a RRP beginning December 11, 2013. Knee ROM was assessed at the preoperative visit and at scheduled postoperative visits for up to 1 year. Differences in mean LOS between the groups were compared using a Poisson regression with and without adjustment for covariates. Repeated measures analysis of covariance was used to evaluate the effects of recovery protocol, time, and the interaction of recovery protocol by time on flexion and flexion contracture. The probability of achieving flexion ≥120° and having a flexion contracture ≥10° was estimated using the SAS/STAT GLIMMIX procedure with a binary distribution and a logit link. RESULTS: The mean LOS for the RRP and SRP groups was 0.8 and 2.5 days, respectively. RRP was associated with greater flexion at 2, 6, and 12 weeks and a higher probability of attaining flexion ≥120° at 6 and 12 weeks. Patients receiving a RRP had less severe flexion contracture and a lower probability of flexion contracture ≥10° at 2, 6, and 12 weeks. DISCUSSION: During the first 12 weeks after TKA, patients who received a RRP had a markedly greater ROM than patients who received a SRP, suggesting that RRP may allow patients to do a greater variety of activities of daily living during the first 3 postoperative months while reducing health care costs. LEVEL OF EVIDENCE: Level III.

Total Knee Arthroplasty Outcomes in Patients with Medicare, Medicare Advantage, and Commercial Insurance.

As more commercial insurance companies adopt a bundled reimbursement model, similar to the Comprehensive Care for Joint Replacement (CJR) algorithm for Medicare beneficiaries, accurate risk adjustment of patient-reported outcomes (PROs) is critical to ensure success. With this movement toward bundled reimbursement, it is unknown if a formula adjusting for similar risks in the Medicare population could be applied to PROs in commercially insured and Medicare Advantage populations undergoing total knee arthroplasty (TKA). This study was performed to compare PROs after TKA in these insurance groups after adjusting for proposed risks. Demographics and clinical data were abstracted from medical records of 302 patients who underwent TKA performed by a single surgeon at a university-based orthopaedic practice during 2013 to 2017. Differences in PROs between commercially insured, Medicare Advantage, and Medicare patients during the 6 months following surgery were evaluated while controlling for demographics, clinical data, and baseline PRO scores. Medicare and Medicare Advantage patients were older (p < 0.001) and had more comorbidities (p = 0.001) than commercial patients. During the first 3 months following TKA, patients in all three groups experienced similar rates of recovery. At 6 months after surgery, outcomes began to diverge by insurance group. Medicare patients reported significantly less ability to perform activities of daily living (78.6 vs. 63.2; p = 0.001), worse physical function (39.6 vs. 44.9; p = 0.003), and more pain interference (57.9 vs. 52.4; p = 0.018) at day 180 than commercially insured patients. There were no statistically significant differences between Medicare Advantage patients and either commercially insured or Medicare patients. Therefore, commercial insurance companies that intend to apply a risk-adjusted equation similar to the CJR algorithm to commercial populations should be cautioned since the postoperative outcomes in this investigation differed after adjusting for the same risk factors that have been proposed for inclusion in the CJR algorithm. Nonetheless, further studies should be performed to ensure that companies participating in bundled reimbursement models have a positive influence on comprehensive health care for patients and providers. This is a level III, retrospective prognostic study.

The Potential Cost Implications of Averting Severe Hypoglycemic Events Requiring Hospitalization in High-Risk Adults With Type 1 Diabetes Using Real-Time Continuous Glucose Monitoring.

BACKGROUND: Severe hypoglycemia remains a major barrier to optimal diabetes management and places a high burden on the US health care system due to the high costs of hypoglycemia-related emergency visits and hospitalizations. Patients with type 1 diabetes (T1DM) who have hypoglycemia unawareness are at a particularly high risk for severe hypoglycemia, the incidence of which may be reduced by the use of real-time continuous glucose monitoring (RT-CGM). METHODS: We performed a cost calculation using values of key parameters derived from various published sources to examine the potential cost implications of standalone RT-CGM as a tool for reducing rates of severe hypoglycemia requiring hospitalization in adult patients with T1DM who have hypoglycemia unawareness. RESULTS: In a hypothetical commercial health plan with 10 million members aged 18-64 years, 9.3% (930 000) are expected to have diagnosed diabetes, with approximately 5% (46 500) having T1DM, of whom approximately 20% (9300) have hypoglycemia unawareness. RT-CGM was estimated to reduce the cost of annual hypoglycemia-related hospitalizations in this select population by $54 369 000, yielding an estimated net cost savings of $8 799 000 to $12 519 000 and a savings of $946 to $1346 per patient. CONCLUSION: This article presents a cost calculation based on available data from multiple sources showing that RT-CGM has the potential to reduce short-term health care costs by averting severe hypoglycemic events requiring hospitalization in a select high-risk population. Prospective, randomized studies that are adequately powered and specifically enroll patients at high risk for severe hypoglycemia are needed to confirm that RT-CGM significantly reduces the incidence of these costly events.

Allergy immunotherapy: reduced health care costs in adults and children with allergic rhinitis.

BACKGROUND: Research demonstrates significant health care cost savings conferred by allergen-specific immunotherapy (AIT) to US children with allergic rhinitis (AR). OBJECTIVE: We sought to examine whether AIT-related cost benefits conferred to US children with AR similarly extend to adults. METHODS: A retrospective (1997-2009) Florida Medicaid claims analysis compared mean 18-month health care costs of patients with newly diagnosed AR who received de novo AIT and were continuously enrolled for 18 months or more versus matched control subjects not receiving AIT. Analyses were conducted for the total sample and separately for adults (age≥18 years) and children (age<18 years). RESULTS: Matched were 4,967 patients receiving AIT (1,319 adults and 3,648 children) and 19,278 control subjects (4,815 adults and 14,463 children). AIT-treated enrollees incurred 38% ($6,637 vs $10,644, P<.0001) lower mean 18-month total health care costs than matched control subjects, with significant savings observed within 3 months of AIT initiation. Compared with control subjects, significantly lower 18-month mean health care costs were demonstrated overall (38%; $6,637 for patients receiving AIT vs $10,644 for control subjects, P<.0001), and for both AIT-treated adults (30%; $10,457 AIT vs $14,854 controls, P<.0001) and children (42%; $5,253 AIT vs $9,118 controls, P<.0001). The magnitude of 18-month health care cost savings realized by AIT-treated adults and children did not significantly differ ($4,397 vs $3,965, P=.435). CONCLUSIONS: Patients with newly diagnosed AR initiating AIT incurred significantly lower health care costs than matched control subjects beginning 3 months after AIT initiation and continuing throughout the 18-month follow-up period. The significant cost benefits achieved by children with AR diagnoses who initiated AIT were also observed for adults with AR diagnoses who initiated AIT.

Clinical and cost efficacy of advanced wound care matrices for venous ulcers.

BACKGROUND: In the United States, venous leg ulcers (VLUs) are commonly associated with substantial disability, impaired quality of life, and high economic costs. Compression therapy, which has remained the standard care for VLUs over several decades, is often insufficient to heal VLUs in a timely manner. VLU-related treatment costs are directly related to time to achieve complete wound closure. Advanced wound care matrices (AWCMs) developed to stimulate wound healing may reduce VLU-related costs associated with delayed healing. Randomized controlled trials (RCTs) have evaluated the wound-healing efficacy of several AWCMs in patients with VLUs. However, comparisons of products' clinical and cost efficacy, which may guide clinical and formulary determinations, are lacking. OBJECTIVE: To evaluate, in terms of number needed to treat (NNT), the comparative clinical and cost efficacy of targeted AWCMs as adjuncts to compression therapy for the treatment of chronic VLUs from the U.S. health care system (payer) perspective. METHODS: A review of published articles (from the earliest available Medline publication date to June 1, 2011) identified RCTs evaluating complete wound closure rates for up to 24 weeks in patients with VLUs treated with targeted AWCMs (Apligraf, Oasis, or Talymed) plus compression therapy compared with compression therapy alone. The most favorable estimates of product efficacy (i.e., those that were statistically significant compared with compression therapy) were used. These included statistically adjusted results for Apligraf as reported in the product insert and the biweekly application for Talymed. Based on the reported efficacy of targeted AWCMs, we calculated the NNT to achieve 1 additional treatment success (i.e., complete wound closure) over that which was achieved with standard therapy alone; 95% CIs were estimated using the Wilson score method proposed by Newcombe. Cost efficacy, defined as the incremental cost per additional successfully treated patient, was then calculated by multiplying the NNT associated with each treatment by the product acquisition cost per treated VLU episode. RESULTS: One study for each of 3 targeted AWCMs (Apligraf [n=130 treatment, n=110 control]; Oasis Wound Matrix [n=62 treatment, n=58 control]; and Talymed [n=22 treatment, n=20 control]) met inclusion criteria. Study designs and wound characteristics varied. Average VLU sizes were 1 cm2, 10-12 cm2, and 10-13 cm2 in the studies of Apligraf, Oasis, and Talymed, respectively. Ulcer duration exceeded 12 months for 50% of patients in the Apligraf study and was at least 7 months for 47% of patients in the Oasis study; patients with ulcers exceeding 6 months were excluded from the study of Talymed. Length of follow-up was 24 weeks for Apligraf, 12 weeks for Oasis, and 20 weeks for Talymed. NNT point estimates of clinical efficacy were 2 for Talymed, 5 for Oasis, and 6 for Apligraf; 95% CIs ranged from 2 to 8 for Talymed, 3 to 24 for Apligraf, and 3 to 39 for Oasis. Incremental costs (95% CIs) per additional successfully treated patient were $1,600 ($1,600-$6,400) for Talymed, $3,150 ($1,890-$24,570) for Oasis, and $29,952 ($14,976-$119,808) for Apligraf. CONCLUSIONS: The most expensive AWCM for the treatment of VLUs did not appear to provide the greatest comparative clinical or cost efficacy. Conclusions must be tempered by the small number of available studies (n=3), variability in trial duration (from 12 to 24 weeks) and baseline wound characteristics, and limitations in study quality. Given the high prevalence, economic burden, and substantial disability of VLUs, and the wide variation in costs for AWCMs, payers need more high-quality head-to-head comparisons to guide coverage and reimbursement determinations for these products.

Medical costs and adherence in patients receiving aqueous versus pressurized aerosol formulations of intranasal corticosteroids.

Intranasal corticosteroid (INS) formulations have different sensory attributes that influence patient preferences, and thereby possibly adherence and health outcomes. This study compares health care use and costs and medication adherence in matched cohorts of patients with allergic rhinitis (AR) using a chlorofluorocarbon-propelled pressurized metered-dose inhaler (pMDI) or aqueous intranasal corticosteroid (A-INS). Florida Medicaid retrospective claims analysis was performed of enrollees aged ≥12 years with at least 1 year of continuous enrollment before their initial AR diagnosis, 1 year for continuous enrollment before their index INS claim, and 18 months of continuous enrollment after their index INS claim during which they received either pMDI or A-INS. pMDI and A-INS patients were matched 1:2 using propensity scores. Nonparametric analyses compared outcomes between matched cohorts at 6, 12, and 18 months of follow-up. A total of 585 patients were matched (pMDI = 195, A-INS = 390). pMDI patients were more adherent to INS, as reflected in their higher median medication possession ratio (53.2% versus 32.7%; p < 0.0001) and fewer median days between fills (73 days versus 111 days; p = 0.0003). Significantly lower median per patient pharmacy fills (34.0 versus 50.5; p < 0.05) and costs ($1282 versus $2178; p < 0.01) were observed among pMDI patients versus A-INS patients 18 months after INS initiation and were maintained when analyses excluded INS fills. Adherence to INS and health care utilization and costs following INS initiation for AR differed by type of formulation received. Our findings suggest patient preferences for INS sensory attributes can drive adherence and affect disease control, and ultimately impact health care costs.

Patients with obsessive-compulsive disorder vs depression have comparable health care costs: a retrospective claims analysis of Florida Medicaid enrollees.

BACKGROUND: The health care burden of obsessive-compulsive disorder (OCD) is relatively unknown. OBJECTIVE: To compare the health care burden of patients with OCD vs depression. METHODS: This retrospective claims analysis compared the 2-year median per-patient health care claims and costs for Florida Medicaid adult enrollees (1997 to 2006) newly diagnosed with "pure OCD" (P-OCD; OCD without comorbid major depression, bipolar disorder, psychosis, organic mental disorder, pervasive developmental disorder, nonpsychotic brain damage, developmental delay, or mental retardation) with matched patients newly diagnosed with "pure depression" (P-D; similar to P-OCD but excluding OCD instead of depression). RESULTS: Eighty-five newly diagnosed P-OCD patients were matched with 14,906 P-D patients. Although median per-patient total health care costs were comparable across groups, patients with P-D incurred significantly higher median outpatient medical costs ($1,928 vs $363, P = .003), while those with P-OCD incurred almost three-fold greater psychiatric costs ($2,028 vs $759, P < .0001). The latter was due primarily to significantly higher costs of psychotropic medications among those with P-OCD ($4,307 vs $2,317, P = .0006) rather than to psychiatric outpatient care. CONCLUSIONS: Patients with P-D and P-OCD carry a similar burden in overall health care costs. However, the burden of those with P-D was largely attributable to outpatient medical costs while that of those with P-OCD was due to higher costs of psychotropic medications.

Agitation in the inpatient psychiatric setting: a review of clinical presentation, burden, and treatment.

Agitation among psychiatric inpatients (particularly those diagnosed with schizophrenia or bipolar disorder) is common and, unless recognized early and managed effectively, can rapidly escalate to potentially dangerous behaviors, including physical violence. Inpatient aggression and violence have substantial adverse psychological and physical consequences for both patients and providers, and they are costly to the healthcare system. In contrast to the commonly held view that inpatient violence occurs without warning or can be predicted by "static" risk factors, such as patient demographics or clinical characteristics, research indicates that violence is usually preceded by observable behaviors, especially non-violent agitation. When agitation is recognized, staff should employ nonpharmacological de-escalation strategies and, if the behavior continues, offer pharmacological treatment to calm patients rapidly. Given the poor therapeutic efficacy and potential for adverse events associated with physical restraint and seclusion, and the potential adverse sequelae of involuntary drug treatment, these interventions should be considered last resorts. Pharmacological agents used to treat agitation include benzodiazepines and first- and second-generation antipsychotic drugs. Although no currently available agent is ideal, recommendations for selecting among them are provided. There remains an unmet need for a non-invasive and rapidly acting agent that effectively calms without excessively sedating patients, addresses the patient's underlying psychiatric symptoms, and is reasonably safe and tolerable. A treatment with these characteristics could substantially reduce the clinical and economic burden of agitation in the inpatient psychiatric setting.

The health economics of allergen immunotherapy.

In contrast to symptomatic drug treatment, which only temporarily relieves allergy symptoms, allergen-specific immunotherapy (SIT) has the potential to alter the course of allergic disease, thereby reducing the need for long-term treatment, the progression of allergic rhinitis (AR) to asthma, and the development of new allergies. The clinical benefits of SIT have been shown to persist for an additional 3 to 12 years after discontinuation of a 2.5- to 5.0-year treatment. It therefore stands to reason that the clinical benefits of SIT also extend to economic benefits. A growing number of studies have evaluated the economic benefits of SIT in patients with AR and/or asthma. The authors critically examine each of these studies published from 1995 to present.

Allergen immunotherapy and health care cost benefits for children with allergic rhinitis: a large-scale, retrospective, matched cohort study.

BACKGROUND: Children with allergic rhinitis (AR) often experience significant impairment in quality of life and health, which increases health care utilization. OBJECTIVE: To determine whether allergen immunotherapy reduces health care utilization and costs in children newly diagnosed as having AR using a retrospective matched cohort design. METHODS: Among children (age <18 years) with a Florida Medicaid paid claim between 1997 and 2007, immunotherapy-treated patients were selected who had newly diagnosed AR, who had not received immunotherapy before their first (index) AR diagnosis, who had received at least 2 immunotherapy administrations after their index AR diagnosis, and who had at least 18 months of data after their first immunotherapy administration. A control group of patients with newly diagnosed AR who had not received immunotherapy either before or subsequent to their index AR diagnosis also were identified, and up to 5 were matched with each immunotherapy-treated patient by age at first AR diagnosis, sex, race/ethnicity, and diagnosis of asthma, conjunctivitis, or atopic dermatitis. RESULTS: Immunotherapy-treated patients had significantly lower 18-month median per-patient total health care costs ($3,247 vs $4,872), outpatient costs exclusive of immunotherapy-related care ($1,107 vs $2,626), and pharmacy costs ($1,108 vs $1,316) compared with matched controls (P < .001 for all). The significant difference in total health care costs was evident 3 months after initiating immunotherapy and increased through study end. CONCLUSIONS: This study demonstrates the potential for early and significant cost savings in children with AR treated with immunotherapy. Greater use of this treatment in children could significantly reduce AR-related morbidity and its economic burden.

Adequacy of pharmacotherapy among medicaid-enrolled patients newly diagnosed with obsessive-compulsive disorder.

OBJECTIVE: To determine the adequacy of pharmacotherapy received by patients with newly-diagnosed obsessive-compulsive disorder (OCD), based on current practice guidelines. METHODS: A 9 year (1997-2006) retrospective claims analysis of adults enrolled in Florida Medicaid for at least 3 continuous years was conducted to determine the percentage who received both a minimally effective duration (> 8 continuous weeks) and dose of first-line OCD pharmacotherapy during the year following their first ("index") OCD diagnosis. RESULTS: Among 2,960,421 adult (> 18 years of age) enrollees, 2,921 (0.1%) were diagnosed with OCD. Among the 2,825 OCD patients without comorbid Asperger syndrome or autism, 843 had newly-diagnosed OCD and at least 12 months of follow-up data after their index diagnosis. Among these 843 patients, 588 (69.7%) received first-line OCD pharmacotherapy but only 323 (38.3%) received a minimally effective pharmacotherapy trial in the year following their index diagnosis. CONCLUSIONS: Among clinically-diagnosed persons with OCD (<10% of those with the disorder), a minority of newly-diagnosed patients receive a minimally effective pharmacotherapy trial consistent with current standards of care. Reasons such as limited patient adherence and/or physician awareness of guidelines must be identified and redressed to ameliorate the patient, healthcare system, and economic burdens associated with OCD.

Allergy immunotherapy among Medicaid-enrolled children with allergic rhinitis: patterns of care, resource use, and costs.

BACKGROUND: Although research demonstrates that allergy immunotherapy (IT) improves allergic rhinitis (AR) outcomes, little is known about IT patterns of care and associated resource use and costs among US children with diagnoses of AR. OBJECTIVE: We sought to examine characteristics associated with receiving IT, patterns of IT care, and health care use and costs incurred in the 6 months before versus after IT. METHODS: We performed retrospective Florida Medicaid claims data (1997-2004) analysis of children (<18 years of age) given new diagnoses of AR. RESULTS: Of 102,390 patients with new diagnoses of AR, 3048 (3.0%) received IT. Male patients, Hispanic patients, and those with concomitant asthma were significantly more likely to receive IT. Approximately 53% completed less than 1 year and 84% completed less than 3 years of IT. Patients who received IT used significantly less pharmacy (12.1 vs 8.9 claims, P < .0001), outpatient (30.7 vs 22.9 visits, P < .0001), and inpatient (1.2 vs 0.4 admissions, P = .02) resources in the 6 months after versus before IT. Pharmacy ($330 vs $60, P < .0001), outpatient ($735 vs $270, P < .0001), and inpatient ($2441 vs $1, P < .0001) costs (including costs for IT care) were significantly reduced after IT. CONCLUSION: Despite suboptimal treatment persistence (only 16% of patients completed 3 years of IT), resource use and costs after treatment were significantly reduced from pre-IT levels.

Computer-assisted self-interviewing (CASI) to improve provider assessment of adherence in routine clinical practice.

Adherence to HIV antiretroviral therapy is closely associated with viral load suppression, progression to AIDS, and death in HIV-infected people. There is, however, no standardized approach to adherence assessment in routine clinical practice, and several studies suggest that providers rarely estimate adherence better than chance. Computer-assisted self-interview technology is an efficient means to identify HIV antiretroviral regimen errors and monitor adherence in order to maximize the benefits of therapy.