Effectiveness of Transcatheter Closure of Patent Foramen Ovale in Clinical Practice.

Background Transcatheter closure of patent foramen ovale (PFO) has reduced the risk of recurrent stroke in patients with cryptogenic strokes in randomized clinical trials. Whether PFO closure in clinical practice is associated with similar benefit remains unknown. Methods and Results We identified patients with PFO and a history of ischemic stroke or transient ischemic attack who were treated with PFO closure or medical therapy in the OptumLabs database. The primary end point was recurrent ischemic stroke or systemic embolization. Secondary outcomes included mortality, all stroke, transient ischemic attack, and major bleeding. A total of 6668 propensity-matched patients were included (PFO closure n=4111; medical therapy n=2557). The incidence of stroke or systemic embolization per 100 person-years was 2.38 after PFO cohort and 2.99 with medical therapy (hazard ratio [HR], 0.85 [95% CI, 0.68-1.05], P=0.13). Mortality was lower in the PFO closure cohort (1.78 versus 2.59 per 100 person-years: HR, 0.69 [95% CI, 0.55-0.87], P=0.002). Falsification end points showed that this difference is unlikely to be completely explained by residual confounders. There were no significant differences between the groups in secondary end points including intracranial hemorrhage and major bleeding except for an increase in nonintracranial hemorrhage bleeding among patients treated with oral anticoagulation (1.42 versus 2.16 per 100 person-years: HR, 0.69 [95% CI, 0.48-0.99], P=0.043). The main end point was consistent in subanalyses including patients <60 years of age, patients with prior stroke, and those treated after the publication of the positive PFO trials in 2017. Conclusions In contemporary US practice, PFO closure is not associated with lower rates of recurrent ischemic stroke or systemic embolization compared with medical therapy. Potential reasons for this discrepancy warrant further investigation.

Out-of-Pocket Cost Burden Associated With Contemporary Management of Advanced Prostate Cancer Among Commercially Insured Patients.

PURPOSE: Out-of-pocket costs represent an important component of financial toxicity and may impact patients' receipt of care. Herein, we evaluated patient-level factors associated with out-of-pocket costs for contemporary advanced prostate cancer treatment options. MATERIALS AND METHODS: We identified all commercially insured men receiving treatment for advanced prostate cancer between 2007 and 2019 within the OptumLabs Data Warehouse®. Patients were categorized into 3 treatment groups: androgen deprivation monotherapy, novel hormonal therapy, and nonandrogen systemic therapy. The primary outcome was out-of-pocket costs in the first year of treatment. The associations of treatment and patient variables with out-of-pocket costs were assessed using multivariable regression models. All costs were adjusted to reflect 2019 U.S. dollars using the Consumer Price Index. RESULTS: In a cohort of 13,409 men 81% (n = 10,926) received androgen deprivation monotherapy, 6% (n = 832) novel hormonal therapy, and 12% (n = 1,651) nonandrogen systemic therapy. Mean treatment-related out-of-pocket costs in the first year were $165, $4,236, and $994 for androgen deprivation monotherapy, novel hormonal therapy, and nonandrogen systemic therapy, respectively. The adjusted difference in annual treatment-related out-of-pocket costs for novel hormonal therapy and nonandrogen systemic therapy were $2,581 (95% CI: $1,923-$3,240) and $752 (95% CI: $600-$903) higher than androgen deprivation monotherapy, respectively. Patient characteristics associated (P < .05) with higher treatment-related out-of-pocket costs included older age (65-74 years), Black race, lower comorbidity scores, and lower household income. CONCLUSIONS: Patients receiving novel hormonal therapy for advanced prostate cancer had substantially higher treatment-related out-of-pocket costs. In addition to raising awareness among prescribers, these data support the inclusion of treatment associated financial toxicity in shared decision making for advanced prostate cancer and call attention to subgroups of patients particularly vulnerable to financial toxicity.

Drug labeling changes and pediatric hematology/oncology prescribing: Measuring the impact of U.S. legislation.

BACKGROUND/AIMS: The Pediatric Research Equity Act and Best Pharmaceuticals for Children Act are intended to promote the conduct of clinical trials that generate pediatric-specific evidence about drug safety and efficacy. This study assesses the quality of evidence generated through Pediatric Research Equity Act-mandated and Best Pharmaceuticals for Children Act-incentivized clinical trials of hematology/oncology drugs and characterizes subsequent changes in pediatric drug utilization rates. METHODS: Trial characteristics (blinding, randomization, and comparator group) were determined for clinical trials that supported pediatric label changes. Using data from OptumLabs® Data Warehouse, a de-identified administrative claims database, we calculated pediatric utilization rates for each drug. We calculated monthly utilization rates from January 2003 (or from the first month in which data were available) to December 2018. RESULTS: We identified 11 hematology/oncology drugs that underwent pediatric label changes under the Pediatric Research Equity Act Pediatric Research Equity Act and/or Best Pharmaceuticals for Children Act, and we identified 15 trials supporting these changes. Of these trials, 36% (5/14) were randomized, 31% (4/13) were blinded, and 36% (5/14) used a comparator group. A median of 49 children (interquartile range 29.5) received the drug under investigation across these trials. Pediatric label changes were not associated with subsequent changes in pediatric drug utilization. Although some drugs saw increased pediatric use after gaining new pediatric indications, this pattern was not consistently observed. In addition, there was no evidence to suggest that drugs were utilized less frequently after they failed to receive pediatric indications. CONCLUSIONS: Clinical trials of hematology/oncology drugs conducted under the Pediatric Research Equity Act Pediatric Research Equity Act and Best Pharmaceuticals for Children Act generally have low methodological rigor, and the resulting label changes are not consistently associated with changes in pediatric utilization. Alternative regulatory strategies and study designs may be necessary to maximize the impact of newly generated knowledge on drug utilization.

National Patterns of Filled Prescriptions and Third-Line Treatment Utilization for Privately Insured Women With Overactive Bladder.

OBJECTIVE: The aim of this study was to evaluate national patterns of care for women with overactive bladder (OAB) in an administrative data set and identify potential areas for improvement. METHODS: We performed an analysis using the OptumLabs Data Warehouse, which contains deidentified administrative claims data from a large national US health insurance plan. The study included women, older than 18 years, with a new OAB diagnosis from January 1, 2007, to June 30, 2017. We excluded those with an underlying neurologic etiology, with interstitial cystitis/painful bladder syndrome, were pregnant, or did not have continuous enrollment for 12 months before and after OAB diagnosis. Trends in management were assessed via the Cochran-Armitage test. Time to discontinuation among medications was compared using t test. RESULTS: Of 1.4 million women in the database during the study time frame, 60,246 (4%) were included in the study. Median age was 61 years [interquartile range (IQR), 50-73], and median follow-up was 2.6 years (IQR, 1.6-4.2). Overall, 37% were treated with anticholinergics, 5% with beta-3 agonists, 7% with topical estrogen, and 2% with pelvic floor physical therapy; 26% saw a specialist; and 2% underwent third-line therapy. Median time to cessation of prescription filling was longer for beta-3 agonists versus anticholinergics [median, 4.1 months (IQR, 1-15) vs 3.6 months (IQR, 1-10); P < 0.0001]. Use of third-line therapies significantly increased over the study time frame, from 1.1% to 2.2% (P < 0.0001). CONCLUSIONS: Most of the patients do not continue filling prescriptions for OAB medications, and a minority of patients were referred for specialty evaluation. Although third-line therapy use is increasing, it is used in a small proportion of women with OAB. Given these patterns, there may be underutilization of specialist referral and other OAB therapies.

Outcomes and complications of operative versus non-operative management of distal radius fractures in adults under 65 years of age.

To compare the outcomes of non-operative versus operative treatment for distal radius fractures in patients aged from 18 to 64 years, we performed a retrospective analysis using the OptumLabs® Data Warehouse using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes of distal radius fracture. Of the 34,184 distal radius fractures analysed, 11,731 (34%) underwent operative management. Short-term complications within 90 days of fracture identified an overall complication rate of 16.6 per 1000 fractures and the 1-year upper extremity-specific complication rate was 287 per 1000 fractures. Overall, post-injury stiffness was the most common 1-year upper extremity-specific complication and was associated with operative management (202.8 vs. 123.4 per 1000 fractures, operative vs. non-operative, p < 0.01). Secondary procedures were significantly more common following non-operative management (8.7% vs. 43%, operative vs. non-operative, p < 0.01) with carpal tunnel release representing the most common secondary procedure. Operative management of distal radius fractures resulted in significantly fewer secondary procedures at the expense of increased overall 1-year complication rates, specifically stiffness.Level of evidence: III.

Autologous Breast Reconstruction versus Implant-Based Reconstruction: How Do Long-Term Costs and Health Care Use Compare?

BACKGROUND: The authors compared long-term health care use and cost in women undergoing immediate autologous breast reconstruction and implant-based breast reconstruction. METHODS: This study was conducted using the OptumLabs Data Warehouse, which contains deidentified retrospective administrative claims data, including medical claims and eligibility information from a large U.S. health insurance plan. Women who underwent autologous or implant-based breast reconstruction between January of 2004 and December of 2014 were included. The authors compared 2-year use rates and predicted costs of care. Comparisons were tested using the t test. RESULTS: Overall, 12,296 women with immediate breast reconstruction were identified; 4257 with autologous (35 percent) and 8039 with implant-based (65 percent) breast reconstruction. The proportion of autologous breast reconstruction decreased from 47.2 percent in 2004 to 32.7 percent in 2014. The mean predicted reconstruction cost of autologous reconstruction was higher than that of implant-based reconstruction in both unilateral and bilateral surgery. Similar results for mean predicted 2-year cost of care were seen in bilateral procedures. However, in unilateral procedures, the 2-year total costs were higher for implant-based than for autologous reconstruction. Two-year health care use rates were higher for implant-based reconstruction than for autologous reconstruction for both unilateral and bilateral procedures. Women undergoing unilateral implant-based reconstruction had higher rates of hospital admissions (30.3 versus 23.1 per 100; p < 0.01) and office visits (2445.1 versus 2283.6 per 100; p < 0.01) than those who underwent autologous reconstruction. Emergency room visit rates were similar between the two methods. Bilateral procedures yielded similar results. CONCLUSION: Although implant-based breast reconstruction is a less expensive index operation than autologous breast reconstruction, it was associated with higher health care use, resulting in similar total cost of care over 2 years.

Outcomes and Complications in the Management of Distal Radial Fractures in the Elderly.

BACKGROUND: The purpose of the present study was to identify trends in management and to compare the outcomes and complications following nonoperative and operative management (including external fixation, closed reduction and percutaneous pinning, and open reduction and internal fixation) for distal radial fractures in patients ≥65 years of age. METHODS: We performed a retrospective analysis, with use of the OptumLabs Data Warehouse database, of patients ≥65 years of age who had been managed for a distal radial fracture between 2009 and 2014 (as indicated by diagnosis codes according to the International Classification of Diseases, Ninth Revision, Clinical Modification). Ninety-day and 1-year complication rates per 1,000 fractures were analyzed overall and by treatment modality. RESULTS: Thirteen thousand, seven hundred and thirteen distal radial fractures were analyzed. The overall 90-day complication rate was 36.5 per 1,000 fractures, and the 1-year upper-extremity-specific complication rate was 236.2 and 307.5 per 1,000 fractures for nonoperative and operative management, respectively. Overall, post-injury stiffness was the most common 1-year upper-extremity-specific complication (incidence, 11.5%). There was no significant difference between operative and nonoperative management in terms of 90-day complication rates. However, operative management had a higher 1-year complication rate than nonoperative management (307.5 versus 236.2 per 1,000 fractures). Overall, the 5 most common upper-extremity-specific complications following operative treatment of distal radial fracture were stiffness (16.0%), chronic regional pain syndrome (9.9%), median neuropathy (8.0%), implant-related complications (3.8%), and tendon-related complications (2.8%). Stiffness was significantly more frequent following operative management (16.0% versus 9.8%; p < 0.01). CONCLUSIONS: Operative management of a distal radial fracture should be carefully considered when discussing treatment options with patients ≥65 years of age. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Risk of De Novo Hepatocellular Carcinoma Following Use of Direct Acting Antiviral Medications for Treatment of Chronic Hepatitis C.

Direct-acting antivirals (DAA) are now the mainstay of treatment for patients with chronic hepatitis C virus (HCV); however, there is some controversy over whether use of DAAs for HCV, as compared with IFN-based regimens, leads to an increased risk for hepatocellular carcinoma (HCC) development. We investigated the association between use of DAAs and subsequent development of HCC in longitudinal data from patients with HCV from diverse backgrounds (various ages, ethnicities, and geographic regions) across the United States. The design was a retrospective study performed using medical and pharmacy claims from OptumLabs. HCV treatment exposure was categorized as DAA-only, DAA + IFN, any-DAA, or IFN-only. To account for confounding by indication, inverse probability of treatment weighting was performed. Cox proportional hazard models were used to calculate hazard ratios (HR) and 95% confidence intervals (CI). We identified 5,781 patients with HCV with no history of HCC at baseline. Compared with IFN-only regimen, no significant increase in HCC risk was found for use of DAA-only (HR, 1.53; 95% CI, 0.73-3.23), DAA + IFN (HR, 1.02; 95% CI, 0.51-2.06), or any-DAA (HR, 1.04; 95% CI, 0.65-1.65). When stratified by sustained virological response (SVR), we noted a higher HCC risk for DAA-only among patients who achieved SVR post-treatment (HR, 7.53; 95% CI, 1.48-38.34), but the CIs were wide, which might be due to the small sample size of the subgroups. Among those who did not achieve SVR, no association was found for use of DAA-only (HR, 0.59; 95% CI, 0.19-1.91). These findings do not provide compelling evidence for the conception that use of DAAs for HCV is associated with increased risk of HCC development.

Ten-Year Trends in Antiemetic Prescribing in Patients Receiving Highly Emetogenic Chemotherapy.

Purpose: Prevention of chemotherapy-induced nausea and vomiting is essential to preserve quality of life in patients with cancer receiving highly emetogenic chemotherapy (HEC). Recently, new drugs (eg, fosaprepitant, and the newer neurokinin-1 receptor antagonists [NK1RAs] rolapitant and netupitant) and updated antiemetic guidelines have emerged. However, trends in real-world antiemetic use are understudied. Methods: We identified patients treated with an initial dose of HEC (either cisplatin or doxorubicin/cyclophosphamide) from January 2006 to June 2016 using administrative claims data from a US commercial insurance database (OptumLabs). Antiemetic use was determined by identifying intravenous/oral/transdermal administration within ±1 day of the chemotherapy dose and/or prescription fill from 14 days before to 7 days after chemotherapy. We used descriptive statistics to present patient demographics, chemotherapy drugs administered, presence/absence of a central intravenous access device, and antiemetics used. Results: A total of 23,030 patients (67.3%) received doxorubicin/cyclophosphamide and 11,206 (32.7%) received cisplatin. Dexamethasone and 5-hydroxytryptamine 3 receptor antagonists (5-HT3RAs) were consistently used by 85% to 95% of patients, consistent with guideline recommendations. NK1RAs were underused early on, but use increased to approximately 80% in the most recently evaluated year. Fosaprepitant use increased precipitously starting in 2009, preceding a sharp decrease in aprepitant use beginning in 2011. Receipt of olanzapine, rolapitant, and netupitant was minimal throughout the study period. Conclusions: Dexamethasone and 5-HT3RAs were used by most patients receiving HEC, in accordance with guideline recommendations. NK1RA use was less adherent with guidelines.

Factors Associated with Emergency Department Utilization and Admission in Patients with Colorectal Cancer.

PURPOSE: We assessed emergency department (ED) utilization in patients with colorectal cancer to identify factors associated with ED visits and subsequent admission, as well as identify a high-risk subset of patients that could be targeted to reduce ED visits. METHODS: Data from Optum Labs Data Warehouse, a national administrative claims database, was retrospectively analyzed to identify patients with colorectal cancer from 2008 to 2014. Multivariable logistic regression was used to identify factors associated with ED visits and ED "super-users" (3+ visits). Repeated measures analysis was used to model ED visits resulting in hospitalization as a logistic regression based on treatments 30 days prior to ED visit. RESULTS: Of 13,466 patients with colorectal cancer, 7440 (55.2%) had at least one ED visit within 12 months of diagnosis. Factors associated with having an ED visit included non-white race, advancing age, increased comorbidities, and receipt of chemotherapy or radiation. 69.2% of patients who visited the ED were admitted to the hospital. A group of 1834 "super-users" comprised 13.6% of our population yet accounted for 52.1% of the total number of ED visits and 32.3% of admissions. CONCLUSIONS: Over half of privately insured patients undergoing treatment for colorectal cancer will visit the ED within 12 months of diagnosis. Within this group, we identify common factors for a high-risk subset of patients with three or more ED visits who account for over half of all ED visits and a third of all admissions. These patients could potentially be targeted with alternative management strategies in the outpatient setting.

Association of Psoriasis With Comorbidity Development in Children With Psoriasis.

Importance: Children with psoriasis are at increased risk for comorbidities. Many children with psoriasis are also overweight or obese; it is unknown whether the increased risk of comorbidities in these children is independent of obesity. Objective: To determine the risk of elevated lipid levels (hyperlipidemia/hypertriglyceridemia), hypertension, metabolic syndrome, polycystic ovarian syndrome, diabetes, nonalcoholic liver disease, and elevated liver enzyme levels in children with and without psoriasis, after accounting for obesity. Design, Setting, and Participants: This was a retrospective cohort study of claims data from Optum Laboratories Data Warehouse (includes 150 million privately insured and Medicare enrollees). A cohort of 29 957 children with psoriasis (affected children) and an age-, sex-, and race-matched comparator cohort of 29 957 children without psoriasis were identified and divided into 4 groups: (1) nonobese, without psoriasis (reference cohort); (2) nonobese, with psoriasis; (3) obese, without psoriasis; and (4) obese, with psoriasis. Main Outcomes and Measures: Risk of developing comorbidities (Cox proportional hazards regression). Results: The overall mean (SD) age of those included in the cohort was 12.0 (4.4) years, and 16 034 (53.5%) were girls. At baseline, more affected children were obese (862 [2.9%] vs 463 [1.5%]; P < .001 for all comparisons). Children with psoriasis were significantly more likely to develop each of the comorbidities than those without psoriasis (P < .01). Obesity was a strong risk factor for development of each comorbidity, even in those without psoriasis (hazard ratios [HRs] ranging from 2.26 to 18.11). The risk of comorbidities was 40% to 75% higher among nonobese children with vs without psoriasis: elevated lipid levels (HR, 1.42; 95% CI, 1.25-1.62), hypertension (HR, 1.64; 95% CI, 1.40-1.93), diabetes (HR, 1.58; 95% CI, 1.27-1.95), metabolic syndrome (HR, 1.62; 95% CI, 1.13-2.33), polycystic ovarian syndrome (HR, 1.49; 95% CI, 1.18-1.88), nonalcoholic liver disease (HR, 1.76; 95% CI, 1.16-2.65), and elevated liver enzyme levels (HR, 1.46; 95% CI, 1.27-1.67). Except for hypertension (P = .03), no significant interaction occurred between psoriasis and obesity on the risk of comorbidities. Conclusions and Relevance: Children with psoriasis are at greater risk of developing obesity, hyperlipidemia, hypertension, diabetes, metabolic syndrome, polycystic ovarian syndrome, nonalcoholic liver disease, and elevated liver function enzyme levels than children without psoriasis. While psoriasis is a small independent risk factor for the development of these comorbidities, obesity is a much stronger contributor to comorbidity development in children with psoriasis.

Photon and Proton Radiation Therapy Utilization in a Population of More Than 100 Million Commercially Insured Patients.

PURPOSE: To characterize the changes in the use of radiation therapy (RT), specifically proton beam radiation therapy (PBRT), among adult and pediatric patients over a 11-year period in a very large population of insured patients. METHODS AND MATERIALS: We conducted a retrospective analysis of the OptumLabs Data Warehouse claims database of more than 100 million insured US enrollees. Descriptive analyses were undertaken to evaluate the characteristics of patients receiving RT from 2002 to 2012. RESULTS: There were 474,533 patients treated with RT from 2002 to 2012. The percentage of patients treated with 3-dimensional conformal radiation therapy, 2-dimensional RT/brachytherapy, intensity modulated radiation therapy (IMRT), stereotactic body radiation therapy (SBRT), and PBRT was 34.5%, 63.4%, 2.1%, 0.0%, and 0.1% and 40.4%, 36.0%, 21.9%, 1.1%, and 0.6% in 2002 and 2012, respectively. The greatest increase in utilization was of IMRT for prostate cancer, growing from 3.5% to 64.0%. For non-prostate cancer adults, IMRT use grew from 1.7% to 16.4%. For children, PBRT utilization increased from 0.3% to 9.7%. For prostate cancer patients, PBRT increased from 0.0% to 2.6%. For all patients, advanced technology (SBRT and PBRT) use was very low at <2%, versus 22% for IMRT. CONCLUSIONS: This is the largest and most geographically diverse description of RT utilization. Proton beam RT utilization remains very low and has had little impact on overall RT utilization compared with IMRT. The largest shift has occurred in IMRT for prostate cancer. Our findings indicate that overall utilization of proton therapy has been low and that its use has likely had little impact on national expenditures on cancer care in the current environment.

Contralateral Prophylactic Mastectomy with Immediate Breast Reconstruction Increases Healthcare Utilization and Cost.

BACKGROUND: The rates of contralateral prophylactic mastectomy (CPM) in women with unilateral breast cancer continue to rise, especially in women undergoing immediate breast reconstruction (IBR). METHODS: We utilized administrative claims data from a large US commercial insurance database (OptumLabs) to identify women age 18-64 years who underwent IBR between January 2004 and December 2013. We compared 2-year unadjusted utilization rates and total costs of care between unilateral mastectomy (UM) and bilateral mastectomy (BM) for implant-based and autologous reconstruction. Comparisons were tested using t-test and differences in cost were estimated using the Wilcoxon rank-sum test. RESULTS: Overall, 11,235 women undergoing mastectomy with IBR were identified; 7319 with implant reconstruction [1923 UM (26%) and 5396 BM (74%)] and 3916 with autologous reconstruction [1687 UM (43%) and 2229 BM (57%)]. The overall rate of office visits (2386 vs. 2391 per 100 women, p = 0.42) and hospital readmission rate (29.1 per 100 women vs. 27.4, p = 0.06) were similar between BM + IBR and UM + IBR. Women undergoing BM + IBR had a higher emergency room (ER) visit rate (34.1 per 100 women vs. 29.8, p < 0.0001). The total 2-year cost of care was higher for BM + IBR than UM + IBR for implant reconstruction ($106,711 vs. $97,218, p < 0.0001) and for autologous reconstruction ($114,725 vs. $87,874, p < 0.0001). CONCLUSIONS: BM + IBR (autologous or implant) was associated with increased ER visits and higher total cost of care over 2 years compared with UM + IBR. Patients considering CPM should be counseled on the additional risks and costs associated with BM + IBR.

Impact of treatment regimen on acute care use during and after adjuvant chemotherapy for early-stage breast cancer.

PURPOSE: The Oncology Care Model was developed, in part, to reduce acute care use during the 6 months after chemotherapy initiation. However, little is known about the impact of chemotherapy regimen on acute care needs, or about later acute care. We sought to assess acute care use over 2 years in patients receiving four contemporary adjuvant chemotherapy regimens for breast cancer. METHODS: Administrative claims data from a large U.S. commercial insurance database (OptumLabs Data Warehouse) were used to retrospectively identify women with early-stage breast cancer who received adjuvant doxorubicin-cyclophosphamide (AC), AC followed or preceded by docetaxel or paclitaxel (AC-T), AC concurrent with docetaxel or paclitaxel (TAC), or docetaxel-cyclophosphamide (TC) between 2008 and 2014. Rates of hospitalizations and emergency department (ED) visits that did not lead to hospitalizations were compared during four sequential 6-month periods among recipients of these four regimens using negative binomial regression (TC = reference). RESULTS: We identified 8621 eligible patients, 87.2% younger than 65. Over 6 months, 11.9% were hospitalized and 17.1% had ED visits. Over 24 months, 17.9% were hospitalized and 28.3% visited the ED. Adjusted rates of hospitalizations/100 patients were significantly higher in AC-T and TAC compared to TC recipients in the first 6 months (14.9, 21.9, and 11.3, respectively, p < 0.001). There were no hospitalization rate differences among regimens later. ED visit rates did not differ significantly by regimen during any 6-month period. CONCLUSION: Higher rates of hospitalizations in recipients of AC-T and TAC were restricted to the chemotherapy administration period, and did not persist afterwards.

Impact of Prostate-specific Antigen (PSA) Screening Trials and Revised PSA Screening Guidelines on Rates of Prostate Biopsy and Postbiopsy Complications.

BACKGROUND: Prostate biopsy and postbiopsy complications represent important risks of prostate-specific antigen (PSA) screening. Although landmark randomized trials and updated guidelines have challenged routine PSA screening, it is unclear whether these publications have affected rates of biopsy or postbiopsy complications. OBJECTIVE: To evaluate whether publication of the 2008 and 2012 US Preventive Services Task Force (USPSTF) recommendations, the 2009 European Randomized Study of Screening for Prostate Cancer and the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial, or the 2013 American Urological Association (AUA) guidelines was associated with changes in rates of biopsy or postbiopsy complications, and to identify predictors of postbiopsy complications. DESIGN, SETTING, AND PARTICIPANTS: This quasiexperimental study used administrative claims of 5279315 commercially insured US men aged ≥40 yr from 2005 to 2014, of whom 104584 underwent biopsy. INTERVENTIONS: Publications on PSA screening. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Interrupted time-series analysis was used to evaluate the association of publications with rates of biopsy and 30-d complications. Logistic regression was performed to identify predictors of complications. RESULTS AND LIMITATIONS: From 2005 to 2014, biopsy rates fell 33% from 64.1 to 42.8 per 100000 person-months, with immediate reductions following the 2008 USPSTF recommendations (-10.1; 95% confidence interval [CI], -17.1 to -3.0; p<0.001), 2012 USPSTF recommendations (-13.8; 95% CI, -21.0 to -6.7; p<0 .001), and 2013 AUA guidelines (-8.8; 95% CI, -16.7 to -0.92; p=0.03). Concurrently, complication rates decreased 10% from 8.7 to 7.8 per 100000 person-months, with a reduction following the 2012 USPSTF recommendations (-2.5; 95% CI, -4.5 to -0.45; p=0.02). However, the proportion of men undergoing biopsy who experienced complications increased from 14% to 18%, driven by nonsepsis infectious complications (p<0.001). Predictors of complications included prior fluoroquinolone use (odds ratio [OR]: 1.27; 95% CI, 1.22-1.32; p<0.001), anticoagulant use (OR: 1.14; 95% CI, 1.04-1.25; p=0.004), and age ≥70 yr (OR: 1.25; 95% CI, 1.15-1.36; p<0.001). Limitations included the retrospective design. CONCLUSIONS: Although there has been an absolute reduction in rates of biopsy and 30-d complications, the relative morbidity of biopsy continues to increase. These observations suggest a need to reduce the morbidity of biopsy. PATIENT SUMMARY: Absolute rates of biopsy and postbiopsy complications have decreased following landmark publications about prostate-specific antigen screening; however, the relative morbidity of biopsy continues to increase.

Trends in Utilization and Outcomes of Hip Arthroscopy in the United States Between 2005 and 2013.

BACKGROUND: The utilization of hip arthroscopy continues to increase in the United States. The purpose of this study was to examine trends in hip arthroscopy procedures and outcomes. METHODS: We performed a retrospective cohort study using Optum Labs Data Warehouse administrative claims data. The cohort comprised 10,042 privately insured enrollees aged 18-64 years who underwent a hip arthroscopy procedure between 2005 and 2013. Utilization trends were examined using age-specific, sex-specific, and calendar-year-specific hip arthroscopy rates. Outcomes were examined using the survival analysis methods and included subsequent hip arthroscopy and total hip arthroplasty (THA). RESULTS: Hip arthroscopy rates increased significantly over time from 3.6 per 100,000 in 2005 to 16.7 per 100,000 in 2013. The overall 2-year cumulative incidence of subsequent hip arthroscopy and THA was 11% and 10%, respectively. In the subset of patients in whom laterality of the subsequent procedure could be determined, about half of the subsequent hip arthroscopy procedures (46%) and almost all of the THA procedures (94%) were on the same side. Decreasing age was significantly associated with the risk of subsequent arthroscopy (P < .01), whereas increasing age was significantly associated with the subsequent risk of THA (P < .01). The 5-year cumulative incidence of THA reached as high as 35% among individuals aged 55-64 years. CONCLUSION: The utilization of hip arthroscopy procedures increased dramatically over the last decade in the 18-64-year-old privately insured population, with the largest increase in younger age-groups. Future studies are warranted to understand the determinants of the large increase in utilization of hip arthroscopy and outcomes.

Impact of the 2009 US Preventive Services Task Force guidelines on screening mammography rates on women in their 40s.

BACKGROUND: The 2009 US Preventive Services Task Force breast cancer screening update recommended against routine screening mammography for women aged 40-49; confusion and release of conflicting guidelines followed. We examined the impact of the USPSTF update on population-level screening mammography rates in women ages 40-49. METHODS AND FINDINGS: We conducted a retrospective, interrupted time-series analysis using a nationally representative, privately-insured population from 1/1/2006-12/31/2011. Women ages 40-64 enrolled for ≥ 1 month were included. The primary outcome was receipt of screening mammography, identified using administrative claims-based algorithms. Time-series regression models were estimated to determine the effect of the guideline change on screening mammography rates. 5.5 million women ages 40-64 were included. A 1.8 per 1,000 women (p = 0.003) decrease in monthly screening mammography rates for 40-49 year-old women was observed two months following the guideline change; no initial effect was seen for 50-64 year-old women. However, two years following the guideline change, a slight increase in screening mammography rates above expected was observed in both age groups. CONCLUSIONS: We detected a modest initial drop in screening mammography rates in women ages 40-49 immediately after the 2009 USPSTF guideline followed by an increase in screening rates. Unfavorable public reactions and release of conflicting statements may have tempered the initial impact. Renewal of the screening debate may have brought mammography to the forefront of women's minds, contributing to the observed increase in mammography rates two years after the guideline change. This pattern is unlikely to reflect informed choice and underscores the need for improved translation of evidence-based care and guidelines into practice.

Association of physician specialty and medical therapy for benign prostatic hyperplasia.

BACKGROUND: Despite little available evidence to determine whether recently introduced selective α-1 blockers and 5-α reductase inhibitors (5-ARIs) are superior to the existing agents in treating benign prostatic hyperplasia (BPH), they are being increasingly prescribed. OBJECTIVE: To describe the prescribing patterns of new and existing agents among patients with incident BPH after the introduction of several new agents and determine whether these varied by physician specialty. RESEARCH DESIGN: We analyzed a retrospective cohort from an administrative claims database from January 2004 through December 2010. SUBJECTS: Patients diagnosed with incident BPH aged 40 years and above and those who received medical management. MEASURES: Receipt of medical therapy for incident BPH (ie, selective α-1 blockers [prazosin (released 1976), terazosin (1987), doxazosin (1990), tamsulosin (1997), alfuzosin (2003), silodosin (2009)] and 5-ARIs [finasteride (1992) and dutasteride (2002)]). RESULTS: A total of 42,769 men with incident BPH received any selective α-1 blocker or 5-ARI. Tamsulosin and dutasteride were the most widely prescribed agents of their respective drug classes. Predicted probabilities showed that urologists were more likely to prescribe alfuzosin (24.0% vs. 7.8%; P<0.001) and silodosin (2.3% vs. 0.4%; P<0.001) when compared with primary care providers (PCPs) at 6 months after diagnosis. Urologists were more likely to prescribe 5-ARIs but less likely to prescribe older α-1 blockers (terazosin, prazosin, and doxazosin) than PCPs at 6 months postdiagnosis. CONCLUSIONS: Among insured patients diagnosed with BPH, our study suggests that the overall use of new agents is rising. In particular, urologists were more likely to prescribe newer selective α-1 blockers compared with PCPs.

Outcomes and total costs of outpatient vs. inpatient peri-procedural anticoagulation management of mechanical prosthetic heart valve patients.

BACKGROUND/OBJECTIVES: The most cost-effective periprocedural management of patients with mechanical heart valves (MHV) is uncertain. The objective was to compare the effectiveness, safety and costs for inpatient intravenous unfractionated heparin (IVUH) vs. outpatient low molecular weight heparin (LMWH) "bridging" as periprocedural anticoagulation management for MHV patients. METHODS: In a case-cohort study, Olmsted County, MN residents with MHV who received outpatient periprocedural LMWH management (cases) over the 11-year period, 1997-2007, were matched to residents with MHV who received inpatient IVUH periprocedural management on valve location and type, and on procedure type. Patients were followed for 3 months following hospitalization to identify thromboembolism (TE) and major bleeding. Total costs from 30 days before to 90 days after the procedure were determined from the Olmsted County Healthcare Expenditure and Utilization Database. Outcomes were compared using survival analysis and costs were compared using the Wilcoxon rank sum. RESULTS: 149 cases (100 aortic, 29 mitral, 20 both; 64% bileaflet) were compared to 149 cohort members (100 aortic, 29 mitral, 20 both; 75% bileaflet). While the 3-month cumulative incidence of TE did not differ significantly among cases (2.7%) and cohort members (4.7%; p = 0.36), major bleeding was significantly lower in cases (5.4% vs. 15.4%; p < 0.005). Total costs were significantly higher for cohort members ($50,984 vs. $39,347; p = 0.002) due to higher inpatient costs ($47,729 vs. $34,860; p = 0.0002). CONCLUSIONS: Outpatient bridging LMWH therapy is equally effective, but safer and less costly than inpatient IVUH as periprocedural anticoagulation management for MHV patients.