Back pain in adolescent idiopathic scoliosis: frequency and risk factors.

PURPOSE: Although back pain is commonly reported in patients with adolescent idiopathic scoliosis (AIS), factors that influence the presence and severity of back pain in AIS, including curve-specific variables, have not been well studied. This study aims to describe the prevalence and severity of back pain in AIS patients and determine the extent to which patient characteristics, including curve-specific factors, are associated with a higher risk of back pain in AIS. METHODS: The study was a retrospective medical records review of adolescents (aged 10-17 years) diagnosed with AIS between 01/01/2018 and 12/31/2021 at an academic tertiary children's hospital. Patients with previous spine surgery were excluded. Variables collected included demographics (age, sex, race, insurance), Lenke classification, major coronal curve, back pain-related information, Risser stage, vitamin D levels, post-diagnosis brace utilization, physical therapy or chiropractic treatment, and surgery. RESULTS: A total of 891 AIS patients were included in the analysis. The sample was predominantly female (73.3%) and insured by Medicaid (57.8) with a mean age of 12.8 years. The mean major coronal curve was 26.3 degrees. Most patients had Lenke type 1 (47%) and type 5 (41%) curves. Nearly half of patients reported back pain (48.5%) with average pain severity in the low-to-moderate range (4.7) on FACES pain scale (0-10). Among those who reported back pain, 63.2% specified a location with the majority reporting pain in the lumbar region (56%) and, less commonly, in the thoracic (39%) and scapular (8%) regions. Lumbar pain was associated with significantly higher pain intensity (p = 0.033). Additionally, the location of pain reported was associated with location of major coronal curve (p < 0.0001). No association was observed between pain presence and vitamin D deficiency (p = 0.571, n = 175), major coronal curve magnitude (p = 0.999), Lenke curve type (p = 0.577), and sex (p = 0.069). Older patients, those insured by Medicaid, and those with higher Risser scores were more likely to report pain scores (p = 0.001 for all). CONCLUSION: Nearly half (48%) of newly diagnosed AIS patients experience back pain which is higher than the prevalence of 33% seen in the general adolescent population. Pain was more prevalent among patients over the age of 13, with heavier body weight, and those insured by Medicaid. Pain was most commonly reported in the lumbar region, especially among patients with lumbar curves. This information can be helpful in counseling AIS patients, though further investigations are needed, especially to determine the underlying causes of back pain in AIS and to elucidate the discrepancy in pain between patients with Medicaid and commercial insurance. LEVEL OF EVIDENCE: Prognostic Study Level II.

Optimal Duration of Physical Therapy Following Total Knee Arthroplasty.

Aims & Objectives: The purpose of this study was to identify patient characteristics associated with engagement and completion of physical therapy (PT) following total knee arthroplasty (TKA) and examine the relationship between number of PT sessions attended and outcomes during the first 12 weeks after surgery. Methods: Patients underwent unilateral primary TKA by a single surgeon and were advised to complete 17 PT sessions over 6 weeks at a hospital-affiliated facility. Analyses examined predictors of PT engagement (attendance of ≥2 sessions) and completion (attendance of 17 ± 1 sessions) within 6 weeks and associations between number of PT sessions attended and changes in range of motion (ROM) and Knee Injury and Osteoarthritis Outcome Score (KOOS) values. Results: Patients living <40 km were more likely to be engaged in PT than those living ≥40 km from the clinic (P < .0001). Among patients who completed PT within 6 weeks, 95.0%, 85.1%, and 56.4% achieved flexion of, respectively, ≥90°, ≥100°, and ≥110°. Among engaged patients, the active flexion thresholds of ≥90°, ≥100°, and ≥110° were achieved by, respectively, 94.4%, 82.5%, and 58.1% by 6 weeks and by 96.7%, 92.1%, and 84.2% by 12 weeks. Improvement in KOOS Symptoms (P = .029), Function in daily living (P = .030) and quality of life (P = .031) linearly decreased as number of PT sessions increased. Conclusions: These results raise the question of whether patients who meet satisfactory outcomes before completing 6 weeks of prescribed PT and those who attend more PT sessions than prescribed may be over-utilizing healthcare resources without additional benefit.

A modern multimodal pain protocol eliminates the need for opioids for most patients following total knee arthroplasty: results from a retrospective comparative cohort study.

PURPOSE: Modern multimodal analgesia has been shown to significantly reduce opioid use following total knee arthroplasty (TKA). This study was conducted to determine if changing TKA discharge opioid prescriptions from automatic to upon request resulted in more opioid free recoveries without compromising pain control. METHODS: Between December 2019 and August 2021, an orthopedic surgeon performed 144 primary unilateral TKAs; patients received the same multimodal analgesia protocol except for postoperative opioid prescribing. The first consecutively-treated cohort automatically received an opioid prescription following discharge (automatic group) and the second cohort received opioid prescriptions only upon request (upon request group). Opioid prescription data were derived from a prescription monitoring program and patient-reported outcomes (PROs) were collected preoperatively and at 2 and 12 weeks postoperatively. RESULTS: A higher percentage of the upon request group was opioid free 3 months after TKA compared with the automatic group (55.6% vs 4.3%, p < 0.0001) without compromising pain or function. Among opioid-naïve patients, 72% in the upon request group were opioid free after TKA compared with 5.4% in the automatic group. Opioid prescribing was not significantly reduced among opioid-experienced patients regardless of the pain protocol. CONCLUSION: Requiring patients to request opioid prescriptions following TKA resulted in a higher rate of opioid free TKA, especially among opioid-naïve patients, without increasing pain compared with offering all patients an initial opioid prescription. LEVEL OF EVIDENCE: Level III.

Predictors of Disparities in Patient-Reported Outcomes before and after Arthroscopic Meniscectomy.

The purpose of this study is to identify predictors of disparities in patient-reported outcome measures (PROMs) before and after arthroscopic meniscectomy. Knee injury and Osteoarthritis Outcome Score (KOOS) was used in this study. All patients who underwent single-knee arthroscopic meniscectomy from January 2012 to March 2018 performed by a single surgeon at an academic safety-net hospital were identified. We excluded patients who had undergone ipsilateral previous knee surgery, bilateral meniscectomy, or concomitant ligament, cartilage, or osteotomy procedures, and those with severe radiographic osteoarthritis in the operated knee, missing preoperative data, or military insurance. Data abstracted from medical records included demographics (age, sex, race, insurance type), clinical characteristics (body mass index, Charlson comorbidity index, and Kellgren-Lawrence [KL] grade), procedure codes, and KOOS assessed before and 90 days after surgery. Multivariable analyses investigated the associations between patient characteristics and the KOOS Pain, other Symptoms, and Function in activities of daily living (ADL) subscales. Among 251 eligible patients, most were female (65.5%), half were of nonwhite race (50.2%), and almost one third were insured by Medicaid (28.6%). Medicaid and black race were statistically significant (p < 0.05) predictors of worse preoperative values for all three KOOS subscales. Medicaid insurance also predicted a lower likelihood of successful surgery, defined as meeting the 10-point minimal clinically important difference, for the KOOS symptoms (p < 0.05) and KOOS ADL (p < 0.05) subscales. Compared with patients without definitive evidence of radiographic osteoarthrosis (KL grade 1), those with moderate radiographic osteoarthritis (KL grade 3) were less likely to have a successful surgical outcome (p < 0.05 for all subscales). Worse preoperative KOOS values predicted worse postoperative KOOS values (p < 0.001 for all subscales) and a lower likelihood of surgical success (p < 0.01 for all subscales). Insurance-based disparities in access to orthopaedic care for meniscus tears may explain worse preoperative PROMs and lower success rates of meniscectomy among Medicaid patients. Patients with meniscus tears and radiological and/or magnetic resonance imaging evidence of osteoarthritis should be carefully evaluated to determine the appropriateness of arthroscopic meniscectomy.

Factors Associated With Loss to Follow-up During the First Year After Total Knee Arthroplasty.

Despite increased pressure to capture patient-reported outcome measures for at least 1 year following total joint arthroplasty (TJA), follow-up rates during the first year after TJA are typically lower than desired and may result in biased findings if data are not missing at random. We conducted a retrospective review of medical records of primary total knee arthroplasty patients treated by a single surgeon at an urban academic private hospital. Main measures were demographics (sex, age, race, and insurance), body mass index, travel distance to clinic, and the Knee Injury and Osteoarthritis Outcome Score (KOOS). Multivariable regression analyses were performed to identify patient characteristics associated with attendance at follow-up visits and predictors of attendance at 6-month follow-up. Among the 205 study patients, follow-up visit attendance declined from a high of 95.7% at day 14 to lows of 69.2% at 6 months and 64.4% at 1 year. Attendance at the previously scheduled follow-up visit was a statistically significant predictor of attendance at 3-month (P=.0015), 6-month (P=.0002), and 1-year (P<.0001) follow-up visits, and travel distance was significantly associated with attending the 1-year follow-up visit (P=.042). Patients with the most favorable KOOS Symptom, Pain, and Function in daily living subscale scores at 3-month follow-up were significantly less likely to attend the 6-month follow-up visit than patients with the least favorable KOOS scores. Prospective studies are needed to identify the full range of factors that may contribute to high rates of loss to follow-up after TJA, which should be of concern to researchers, clinicians, and hospitals. [Orthopedics. 2023;46(2):93-97.].

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.

Patient Characteristics Independently Associated With Knee Osteoarthritis Symptom Severity at Initial Orthopedic Consultation.

BACKGROUND/OBJECTIVE: The objective of this study was to identify patient and disease characteristics associated with the symptomatic severity of knee osteoarthritis (OA) at the time of initial knee OA diagnosis by an orthopedist. METHODS: This medical records review included patients initially diagnosed with knee OA during 2016 to 2017 by a single orthopedic surgeon in a university-based tertiary care setting. All variables were assessed at first OA diagnosis. Main outcomes were subscales of the Knee Injury and Osteoarthritis Outcome Score-Pain, other Symptoms, knee-related quality of life, and function in daily living. Multivariable regression analyses examined the following predictors of main outcomes: sex, race, age, insurance type, body mass index, Charlson comorbidity index, and radiographic OA severity (Kellgren-Lawrence grade). RESULTS: Of the 559 patients included in the study, most were African American (52.1%), female (71.7%), and had severe radiographic OA (Kellgren-Lawrence grade, 4; 68.7%). Female sex, African American racial/ethnic group, Medicaid insurance, younger age, and severe radiographic OA were independently statistically significantly associated with worse symptoms, pain, and function (p < 0.05 for all). Body mass index and Charlson comorbidity index were not statistically significant predictors of any outcome. CONCLUSIONS: This study identified disparities in the perception of knee OA problems at initial orthopedist diagnosis based on sex, age, race, insurance, and radiographic OA severity. Because most of these variables are also associated with more rapid progression of OA, identifying their biopsychosocial underpinnings may help determine which interventions are most likely to redress these disparities and delay progression to end-stage knee OA.

Objective Data Reveals Gender Preferences for Patients' Primary Care Physician.

BACKGROUND AND OBJECTIVES: Most studies based on self-reported data indicate that female patients more often than males have a same-gender preference for their primary care physician (PCP). Because self-reported preferences may not reflect true preferences, we analyzed objective data to investigate patients' preferences for PCP gender. METHODS: Analyses were performed on 2192 new patients seen within a university-based healthcare system by 13 PCPs (2 male, 11 female) during 2017. New patients were asked about their PCP gender preference when assigned a PCP. We compared the expected prevalence (proportion of males/females in overall patient population) and observed prevalence (gender distribution of patients for each PCP) by PCP gender. A mixed model with PCP as a random effect examined the odds of male and female patients being assigned a same-gender physician. RESULTS: The expected prevalence of new patients was 65% female and 35% male. The observed prevalence (95% confidence interval [CI]) of male patients among male and female PCPs was, respectively, 59.7% (49.0%-69.5%) and 28.0% (24.0%-32.4%), with neither CI containing the expected prevalence of male patients (35%). Similarly, the observed prevalence of female patients among male and female PCPs was, respectively, 40.3% (95% CI 30.5%-51.0%) and 72.0% (95% CI 67.6%-76.0%), with neither CI containing the expected prevalence of female patients (65%). CONCLUSIONS: Both male and female patients often preferred to see a same-gender PCP with this preference more pronounced in males. Future research should seek to clarify the relationships between patients' gender preferences, patient-physician gender concordance/discordance, patient satisfaction, and health outcomes.

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.

Achieving Validated Thresholds for Clinically Meaningful Change on the Knee Injury and Osteoarthritis Outcome Score After Total Knee Arthroplasty: Findings From a University-based Orthopaedic Tertiary Care Safety Net Practice.

A lack of knowledge exists about which patient characteristics predict failure to meet validated thresholds for clinically meaningful change on the Knee Injury and Osteoarthritis Outcome Score (KOOS) after total knee arthroplasty (TKA). METHODS: A retrospective chart review was performed on patients who underwent primary TKA by a single surgeon between January 2013 and June 2018. Variables included demographics (age, sex, race, and insurance type), comorbidities, body mass index, and preoperative KOOS subscale scores. Multivariate logistic regression was performed to identify characteristics associated with failing to meet or exceed the minimal clinically important difference (MCID) and substantial clinical benefit (SCB) on each KOOS subscale 6 months after TKA. RESULTS: A total of 159 patients were included. At 6 months after TKA, approximately one-third of patients (21% to 32%) failed to meet or exceed the MCID and 27% to 39% failed to meet or exceed the SCB on all KOOS subscales. Better preoperative KOOS Symptoms, quality of life, and activities of daily living subscale scores were statistically significantly associated with failing to meet the MCID and SCB on each respective subscale. Demographics, comorbidities, and body mass index were not notable predictors of either outcome for any of the KOOS subscales. DISCUSSION: About one-third of TKA patients in this single-site, single-surgeon sample failed to achieve a clinically meaningful outcome, and up to 4 in 10 patients had a less-than-ideal outcome 6 months after surgery. Surgeons should take care to set realistic expectations for patients with the least severe knee problems before TKA because this subgroup is especially at a high risk of failing to achieve a satisfactory outcome.

Supartz (Sodium Hyaluronate) for the Treatment of Knee Osteoarthritis: A Review of Efficacy and Safety.

As concerns about the safety of systemic oral pharmacologic treatments for knee osteoarthritis (OA) mount, clinicians have increased the use of intra-articular hyaluronic acid (IA-HA) in managing mild-to-moderate knee OA. Supartz (sodium hyaluronate; Seikagaku Corporation, Tokyo, Japan) is the first IA-HA product to be approved in the world and has the longest history of global use. In this review, we summarize evidence supporting Supartz efficacy and safety, including data from pivotal clinical trials that resulted in approval of Supartz in the United States and Japan, the safety of single and repeated courses of Supartz, and Supartz efficacy using objective outcomes and in special populations. There is strong evidence that single 5-week courses of Supartz provide clinically meaningful reductions in pain and improved function for up to 6 months without risk of serious side effects or complications. Repeated courses of Supartz are as safe as single courses and have an extremely low risk of infection. Findings from promising initial studies, which suggest that Supartz may improve muscle strength, gait pattern, and balance, should be confirmed in randomized controlled trials.

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.

Improving screening and diagnosis of exercise-induced bronchoconstriction: a call to action.

This article summarizes the findings of an expert panel of nationally recognized allergists and pulmonologists who met to discuss how to improve detection and diagnosis of exercise-induced bronchoconstriction (EIB), a transient airway narrowing that occurs during and most often after exercise in people with and without underlying asthma. EIB is both commonly underdiagnosed and overdiagnosed. EIB underdiagnosis may result in habitual avoidance of sports and physical activity, chronic deconditioning, weight gain, poor asthma control, low self-esteem, and reduced quality of life. Routine use of a reliable and valid self-administered EIB screening questionnaire by professionals best positioned to screen large numbers of people could substantially improve the detection of EIB. The authors conducted a systematic review of the literature that evaluated the accuracy of EIB screening questionnaires that might be adopted for widespread EIB screening in the general population. Results of this review indicated that no existing EIB screening questionnaire had adequate sensitivity and specificity for this purpose. The authors present a call to action to develop a new EIB screening questionnaire, and discuss the rigorous qualitative and quantitative research necessary to develop and validate such an instrument, including key methodological pitfalls that must be avoided.

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.

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.

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.