The symptom experience of hereditary angioedema (HAE) patients beyond HAE attacks: literature review and clinician interviews.

BACKGROUND: Hereditary angioedema (HAE) is a genetic disorder characterized by re-occurring swelling episodes called "attacks," usually in the limbs, face, airways, and intestinal tract. New prophylactic therapies have reduced the frequency of these attacks. This study describes results from a literature review and clinician interviews assessing patient HAE symptom experiences and timing, and then evaluates whether existing patient-reported outcome (PRO) tools adequately reflect this experience. METHODS: A targeted literature review as well as interviews with key opinion leaders (KOLs), were conducted to capture information about the patient experience and their symptoms. An assessment of various PROs was then conducted to determine how well they each covered HAE symptoms and impacts. RESULTS: Nineteen HAE symptoms were identified. KOLs reported that patients on prophylactic therapy experienced some symptoms indicating an attack was imminent, but then never experienced an attack. The comparison of the different PROs found that the Hereditary Angioedema Patient-Reported Outcome was the instrument that most thoroughly examined the symptoms of patients with HAE. CONCLUSIONS: Given the introduction of new prophylactic therapies, further research is needed to determine the effect of being attack-free for longer periods of time on health-related quality of life.

Hereditary angioedema C1-esterase inhibitor replacement therapy and coexisting autoimmune disorders: findings from a claims database.

In this letter to the editor, we present results of claims data analysis. This claims data analysis supports a hypothesis that in patients with hereditary angioedema due to C1-esterase inhibitor (C1-INH) deficiency, the occurrence and/or symptomatology of coexisting autoimmune disease may be positively influenced by a replacement therapy with plasma derived C1-INH.

Impact of binge eating disorder on functional impairment and work productivity in an adult community sample in the United States.

AIM: This study compared functioning and productivity in individuals meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for binge eating disorder (BED) to those without BED. METHODS: A sample of US adults from the National Health and Wellness Survey completed an Internet survey in October 2013. In addition to BED diagnostic criteria, the survey assessed functional impairment and productivity, respectively, using the Sheehan Disability Scale (SDS) and Work Productivity and Activity Impairment (WPAI) questionnaire. Differences between BED and non-BED respondents were assessed using multivariate models controlling for factors, including age, sex and comorbidities. RESULTS: Of 22 397 respondents, 344 were categorised as BED respondents and 20 437 as non-BED respondents. Compared with non-BED respondents, BED respondents exhibited significantly (all P<.001) greater functional impairment on the SDS, as measured by mean±SD total (14.04±9.46 vs 3.41±6.36), work/school (3.86±3.62 vs 1.01±2.21), social life/leisure activities (5.29±3.49 vs 1.22±2.33) and family life/home responsibilities (4.89±3.44 vs 1.18±2.26) scores. Adjusted odds ratios (95% CIs) indicated that BED respondents were more impaired than non-BED respondents on the work/school (4.24 [3.33-5.40]), social life/leisure activities (6.37 [4.97-8.15]) and family life/home responsibilities (5.76 [4.51-7.34]) domains of the SDS. On the WPAI, BED respondents reported significantly (all P<.001) higher percentages (mean±SD) of absenteeism (9.59%±19.97% vs 2.90%±12.95%), presenteeism (30.00%±31.64% vs 10.86%±20.07%), work productivity loss (33.19%±33.85% vs 12.60%±23.22%) and activity impairment (43.52%±34.36% vs 19.94%±27.22%) than non-BED respondents. CONCLUSIONS: The findings suggest individuals with BED experience considerable impairment in functioning and work productivity compared with individuals without BED.

Health-related quality of life with hereditary angioedema following prophylaxis with subcutaneous C1-inhibitor with recombinant hyaluronidase.

BACKGROUND: To estimate health-related quality-of-life changes in patients with hereditary angioedema due to C1-inhibitor (C1-INH) deficiency who received subcutaneous C1-INH with recombinant hyaluronidase (rHuPH20) for attack prophylaxis in a randomized, double-blind, dose-ranging, cross-over study. METHODS: Patients with type I/II hereditary angioedema received 1000 U of C1-INH with 24,000 U of rHuPH20 or 2000 U of C1-INH with 48,000 U of rHuPH20 every 3-4 days for 8 weeks and then crossed over for another 8-week period. The study was terminated early as a precaution related to non-neutralizing antibodies to rHuPH20. The Angioedema Quality of Life questionnaire (AE-QoL) was administered at weeks 1 and 5 of both periods, and at 1 week after the second treatment period. Changes in AE-QoL scores were calculated over both treatment periods and within each treatment period for patients with ≥4 weeks of treatment. RESULTS: Forty-one patients had evaluable AE-QoL data, and 22 patients completed treatment. At screening, 43% of the patients were receiving intravenous C1-INH. A significant average AE-QoL total score decline (improvement) of -8.1 (95% confidence interval, -13.7 to -2.5) was observed from baseline to the end of the study, and significant AE-QoL score declines were observed in the Functioning, Fear/Shame, and Nutrition domains. Patients on 2000 U reported higher mean AE-QoL score declines in Functioning and Nutrition domains relative to the 1000 U dose. Overall, 43.9% of all the patients, 45.5% of the study completers, and 46.7% of the nonprophylaxis users at baseline on high treatment doses achieved a reduction in the AE-QoL total score of six points. CONCLUSION: Despite early termination and prestudy prophylactic intravenous C1-INH use by 43% of the patients, improved AE-QoL scores were observed after ≤16 weeks of subcutaneous C1-INH-rHuPH20 prophylaxis.

Characteristics and use of treatment modalities of patients with binge-eating disorder in the Department of Veterans Affairs.

OBJECTIVE: In 2013 binge-eating disorder (BED) was recognized as a formal diagnosis, but was historically included under the diagnosis code for eating disorder not otherwise specified (EDNOS). This study compared the characteristics and use of treatment modalities in BED patients to those with EDNOS without BED (EDNOS-only) and to matched-patients with no eating disorders (NED). METHODS: Patients were identified for this study from electronic health records in the Department of Veterans Affairs from 2000 to 2011. Patients with BED were identified using natural language processing and patients with EDNOS-only were identified by ICD-9 code (307.50). First diagnosis defined index date for these groups. NED patients were frequency matched to BED patients up to 4:1, as available, on age, sex, BMI, depression, and index month encounter. Baseline characteristics and use of treatment modalities during the post-index year were compared using t-tests or chi-square tests. RESULTS: There were 593 BED, 1354 EDNOS-only, and 1895 matched-NED patients identified. Only 68 patients with BED had an EDNOS diagnosis. BED patients were younger (48.7 vs. 49.8years, p=0.04), more were male (72.2% vs. 62.8%, p<0.001) and obese (BMI 40.2 vs. 37.0, p<0.001) than EDNOS-only patients. In the follow-up period fewer BED (68.0%) than EDNOS-only patients (87.6%, p<0.001), but more BED than NED patients (51.9%, p<0.001) used at least one treatment modality. DISCUSSION: The characteristics of BED patients were different from those with EDNOS-only and NED as was their use of treatment modalities. These differences highlight the need for a separate identifier of BED.

A systematic review of the health-related quality of life and economic burdens of anorexia nervosa, bulimia nervosa, and binge eating disorder.

PURPOSE: To perform a systematic review of the health-related quality of life (HRQoL) and economic burdens of anorexia nervosa (AN), bulimia nervosa (BN), and binge eating disorder (BED). METHODS: A systematic literature search of English-language studies was performed in Medline, Embase, PsycINFO, PsycARTICLES, Academic Search Complete, CINAHL Plus, Business Source Premier, and Cochrane Library. Cost data were converted to 2014 Euro. RESULTS: Sixty-nine studies were included. Data on HRQoL were reported in 41 studies (18 for AN, 17 for BN, and 18 for BED), on healthcare utilization in 20 studies (14 for AN, 12 for BN, and 8 for BED), and on healthcare costs in 17 studies (9 for AN, 11 for BN, and only 2 for BED). Patients' HRQoL was significantly worse with AN, BN, and BED compared with healthy populations. AN, BN, and BED were associated with a high rate of hospitalization, outpatient care, and emergency department visits. However, patients rarely received specific treatment for their eating disorder. The annual healthcare costs for AN, BN, and BED were €2993 to €55,270, €888 to €18,823, and €1762 to €2902, respectively. CONCLUSIONS: AN, BN, and BED have a serious impact on patient's HRQoL and are also associated with increased healthcare utilization and healthcare costs. The burden of BED should be examined separately from that of BN. The limited evidence suggests that further research is warranted to better understand the differences in long-term HRQoL and economic burdens of AN, BN, and BED.

Knowledge of binge eating disorder: a cross-sectional survey of physicians in the United States.

OBJECTIVES: Binge eating disorder (BED)--now a designated disorder in the DSM-5--is the most prevalent eating disorder (ED), affecting 2-3% of the US population. This survey of US physicians assesses how BED is diagnosed, treated and referred. METHODS: Internists, family practitioners, obstetrics/gynecologist (OB/GYNs) and psychiatrists were randomly selected from a nationally-representative panel. Participants completed an online survey and reviewed case vignettes consistent with DSM-5-defined BED, then answered questions to elicit whether they would assess for psychiatric conditions including EDs. Those reporting they would screen and who correctly identified BED in vignettes received additional questions about BED diagnosis, treatment, and referral patterns. RESULTS: Of 278 physicians surveyed, 96% were board-certified and 87% had practiced >10 years. 23% were psychiatrists, 27% family practitioners, 31% internists and 19% OB/GYNs. 92% were 'somewhat likely' to screen for ED after reviewing DSM-5-consistent vignettes. 206 (74%) correctly identified BED. Of these, 33% and 68% reported they proactively screen eating habits for all patients and obese patients, respectively. 10% reported not screening eating habits even in the presence of ED symptoms. Fewer than half reported using DSM criteria in Diagnosing BED, and 56 (27%) did not recognize BED to be a discreet ED. CONCLUSION: Although ED awareness is improving, understanding BED as a distinct ED is lacking, which may result in low rates of screening and diagnosis. This study illustrates how taking a complete patient history (including probing BED characteristics) may be an effective first-line strategy for clinicians to facilitate optimal care for these patients.

Healthcare costs and resource utilization of patients with binge-eating disorder and eating disorder not otherwise specified in the Department of Veterans Affairs.

OBJECTIVE: The objective of this study was to compare the one-year healthcare costs and utilization of patients with binge-eating disorder (BED) to patients with eating disorder not otherwise specified without BED (EDNOS-only) and to matched patients without an eating disorder (NED). METHODS: A natural language processing (NLP) algorithm identified adults with BED from clinical notes in the Department of Veterans Affairs (VA) electronic health record database from 2000 to 2011. Patients with EDNOS-only were identified using ICD-9 code (307.50) and those with NLP-identified BED were excluded. First diagnosis date defined the index date for both groups. Patients with NED were randomly matched 4:1, as available, to patients with BED on age, sex, BMI, depression diagnosis, and index month. Patients with cost data (2005-2011) were included. Total healthcare, inpatient, outpatient, and pharmacy costs were examined. Generalized linear models were used to compare total one-year healthcare costs while adjusting for baseline patient characteristics. RESULTS: There were 257 BED, 743 EDNOS-only, and 823 matched NED patients identified. The mean (SD) total unadjusted one-year costs, in 2011 US dollars, were $33,716 ($38,928) for BED, $37,052 ($40,719) for EDNOS-only, and $19,548 ($35,780) for NED patients. When adjusting for patient characteristics, BED patients had one-year total healthcare costs $5,589 higher than EDNOS-only (p = 0.06) and $18,152 higher than matched NED patients (p < 0.001). DISCUSSION: This study is the first to use NLP to identify BED patients and quantify their healthcare costs and utilization. Patients with BED had similar one-year total healthcare costs to EDNOS-only patients, but significantly higher costs than patients with NED.

Epidemiology, health-related quality of life and economic burden of binge eating disorder: a systematic literature review.

PURPOSE: To perform a systematic review on the epidemiology, the health-related quality of life (HRQoL) and economic burden of binge eating disorder (BED). METHODS: A systematic literature search of English-language articles was conducted using Medline, Embase, PsycINFO, PsycARTICLES, Academic Search Complete, CINAHL Plus, Business Source Premier and Cochrane Library. Literature search on epidemiology was limited to studies published between 2009 and 2013. Cost data were inflated and converted to 2012 US$ purchasing power parities. All of the included studies were assessed for quality. RESULTS: Forty-nine articles were included. Data on epidemiology were reported in 31, HRQoL burden in 16, and economic burden in 7 studies. Diagnosis of BED was made using 4th Edition of The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria in 46 studies. Lifetime prevalence of BED was 1.1-1.9% in the general population (DSM-IV). BED was associated with significant impairment in aspects of HRQoL relating to both physical and mental health; the Short Form 36 Physical and Mental Component Summary mean scores varied between 31.1 to 47.3 and 32.0 to 49.8, respectively. Compared to individuals without eating disorder, BED was related to increased healthcare utilization and costs. Annual direct healthcare costs per BED patient ranged between $2,372 and $3,731. CONCLUSIONS: BED is a serious eating disorder that impairs HRQoL and is related to increased healthcare utilization and healthcare costs. The limited literature warrants further research, especially to better understand the long-term HRQoL and economic burden of BED.

Automated identification of patients with a diagnosis of binge eating disorder from narrative electronic health records.

Binge eating disorder (BED) does not have an International Classification of Diseases, 9th or 10th edition code, but is included under 'eating disorder not otherwise specified' (EDNOS). This historical cohort study identified patients with clinician-diagnosed BED from electronic health records (EHR) in the Department of Veterans Affairs between 2000 and 2011 using natural language processing (NLP) and compared their characteristics to patients identified by EDNOS diagnosis codes. NLP identified 1487 BED patients with classification accuracy of 91.8% and sensitivity of 96.2% compared to human review. After applying study inclusion criteria, 525 patients had NLP-identified BED only, 1354 had EDNOS only, and 68 had both BED and EDNOS. Patient characteristics were similar between the groups. This is the first study to use NLP as a method to identify BED patients from EHR data and will allow further epidemiological study of patients with BED in systems with adequate clinical notes.

Clinical and cost outcomes of venous thromboembolism in Medicare patients undergoing total hip replacement or total knee replacement surgery.

BACKGROUND: Venous thromboembolism (VTE) occurs most often during hospitalization for major surgery or trauma but may also occur up to several months after surgery. Since the potential for VTE exists in a range of clinical settings, an assessment of its impact on overall outcomes and costs to the patient and to the healthcare system is warranted. OBJECTIVE: To evaluate the effects of VTE (deep vein thrombosis, pulmonary embolism, or both) occurring within the first 30 days of hospital discharge for total hip replacement (THR) or total knee replacement (TKR) surgery on inpatient costs, mortality, rehospitalization, and major bleeding within 1 year after initial hospitalization for THR or TKR surgery. METHODS: The Medicare Provider Analysis and Review (MEDPAR) file for calendar years 2005-2007 provided hospital discharge abstracts for the fee-for-service, acute-care hospitalizations of all Medicare recipients. All patients included in the analysis underwent THR (n = 51,108) or TKR (n = 115,627). VTE events were diagnosed within the first 30 days and within 1 year post discharge. Propensity score matching was used to control for differences in baseline characteristics in patients with and without VTE events. Total cost was measured as Medicare cost plus beneficiary out-of-pocket cost. RESULTS: VTE occurred in 0.74% of patients undergoing THR. For patients with VTE versus no VTE, mortality was higher (2.9% vs 0.4%, P < 0.001) and rehospitalization within 1 year was more frequent (51.9% vs 22.4%, P < 0.001), as were complications such as bleeding (11.2% vs 2.7%, P < 0.001). Risk-adjusted Medicare cost and total healthcare cost, including beneficiary cost share in 1 year, were significantly higher for VTE patients versus patients with no VTE ($18,929 vs $3763, P < 0.001). VTE occurred in 0.70% of patients undergoing TKR. For patients with VTE versus no VTE, mortality was higher (2.5% vs 0.15%, P < 0.001), and rehospitalization within 1 year was more frequent (48.7% vs 20.7%, P < 0.001), as were complications such as bleeding (13.7% vs 2.1%, P < 0.001). For TKR surgery, risk-adjusted total healthcare cost, including beneficiary cost share in 1 year, was significantly different for VTE versus no VTE ($17,996 vs $4358, P < 0.001). LIMITATIONS: Study limitations include a reliance on ICD-9-CM codes, which could be inaccurate, and the inability (1) to control for unmeasured confounders, such as surgeons' skills; (2) to include outpatient medical care costs; and (3) to ensure that all patients were enrolled continuously throughout the study period. CONCLUSIONS: VTE after THR or TKR is associated with higher mortality, rehospitalization, and bleeding within 1 year, compared with no VTE. Risk-adjusted total, Medicare, and beneficiary healthcare costs were significantly higher for both THR and TKR patients with VTE (P < 0.001).

Anticoagulation Bridging Therapy Patterns in Patients Undergoing Total Hip or Total Knee Replacement in a US Health Plan: Real-World Observations and Implications.

BACKGROUND: The necessity for anticoagulant bridging therapy after joint replacement surgery is widely understood, but treatment administration patterns in the prevention of venous thromboembolism (VTE) after total hip replacement (THR) or total knee replacement (TKR) surgery during the hospital stay have yet to be examined. OBJECTIVE: To investigate anticoagulation thromboprophylaxis patterns, especially the use of anticoagulant bridging therapy and/or nonbridged treatment strategies, in patients undergoing THR/TKR surgery. METHODS: This retrospective study was based on a large hospital database linked with outpatient claims from 2005 through 2007. The study population included 1770 patients who were admitted for either THR or TKR surgery and were aged ≥18 years on the date of the surgery, defined as the index date. Patients were required to have commercial insurance or Medicare coverage and be continuously enrolled in their health plan for at least 180 days before and 90 days after the index date. The data were analyzed retrospectively for risk-adjusted postsurgery VTE and major bleeding events among patients receiving anticoagulation thromboprophylaxis. Patterns of anticoagulant bridging therapy use were also assessed. A risk adjustment was performed using propensity score matching. RESULTS: Of 1770 eligible patients, 1551 (88%) received anticoagulant VTE prophylaxis; 264 (15%) received combination low-molecular-weight heparin and warfarin. Of these, 105 (40%) patients were switched between the 2 monotherapies, and 159 (60%) received bridged (overlapping) prophylaxis. The overall rates of VTE and bleeding events were significantly lower with bridged therapy than with nonbridged therapy (5.8% vs 18.4%, respectively, for VTE, P <.02; 2.3% vs 4.60% for major bleeding, P = .41; 1.15% vs 8.05% for minor bleeding, P <.03). CONCLUSION: Although existing guidelines recommend anticoagulant bridging therapy after THR or TKR surgery, the limited data regarding anticoagulant bridging practice patterns suggest that patients who undergo such surgery do not receive adequate anticoagulant thromboprophylaxis immediately after discharge. Our findings suggest that increased use of bridging therapy after THR or TKR surgery may help improve postsurgery patient outcomes by reducing VTE and bleeding rates.

Impact of postoperative venous thromboembolism on Medicare recipients undergoing total hip replacement or total knee replacement surgery.

PURPOSE: The impact of postoperative venous thromboembolism (VTE) during initial hospitalization for total hip replacement (THR) or total knee replacement (TKR) surgery was assessed. METHODS: Using Medicare Provider Analysis and Review files, patients who underwent THR, TKR, or hip fracture surgery from 2005 to 2007 were identified using appropriate procedure codes from the International Classification of Diseases, 9th Revision, Clinical Modification. Medicare managed care patients were excluded from the study. Eligible patients were classified as having had deep venous thrombosis (DVT), pulmonary embolism (PE), DVT and PE, or no VTE during their initial hospitalization. Risk adjustment was performed using propensity score matching. Medicare cost, cost to beneficiaries, and cost to primary payers were analyzed to determine risk-adjusted differences in outcome measures, including mortality, rehospitalization, bleeding, length of stay, and total health care expenditures related to VTE events. RESULTS: A total of 170,047 patients were identified. Postoperative VTE events occurred in 3,014 patients (1.77%) during their initial hospitalization. Risk-adjusted mortality rates were three to four times higher for patients with VTE compared with those without VTE. Patients with VTE were more likely to be rehospitalized and experience bleeding within 30 days. Risk-adjusted differences in annual mean cost, including Medicare cost and costs to beneficiaries and primary payers, were significantly greater for patients with VTE. CONCLUSION: Patients who developed VTE after THR or TKR had a higher likelihood of mortality, bleeding, and rehospitalization; were hospitalized longer; and incurred higher costs to Medicare, Medicare beneficiaries, and private payers compared with patients without VTE.

Analysis of venous thromboprophylaxis duration and outcomes in orthopedic patients.

BACKGROUND: Venous thromboembolism (VTE) following total hip replacement (THR) and total knee replacement (TKR) surgery imposes significant health and economic burden. OBJECTIVE: To examine the impact of thromboprophylaxis duration on deep vein thrombosis (DVT), pulmonary embolism (PE), total VTE (DVT and PE), and bleeding events among THR/TKR patients. METHODS: A retrospective study (April 1, 2004, to December 31, 2006) was conducted using a US health plan claims database linked to an inpatient database containing medication use. Outcomes were compared using χ2 tests; predictors of outcomes were analyzed using multivariate logistic regression. RESULTS: Of 3497 patients, 3195 (91%) received thromboprophylaxis for =1 day postsurgery. Most patients (67%) received short-duration (1-14 days) rather than extended-duration (>14 days) thromboprophylaxis. The incidence of thromboembolic and bleeding events was higher in those who received short-duration thromboprophylaxis: DVT (2.84% vs 1.24%; P = .0038), PE (1.12% vs 0.19%; P = .0052), total VTE (3.96% vs 1.43%; P <.0001), and major bleeding (1.68% vs 0.38%; P = .0011). Multivariate logistic regressions (adjusted for observed demographic and clinical characteristics) revealed similar results. Baseline comorbidity score was significantly associated with major bleeding; most of the bleeding events in those who received short-duration thromboprophylaxis occurred within the first 14 days. CONCLUSIONS: In this database analysis of patients who had undergone THR/TKR surgery, a large proportion of patients did not receive the minimum duration of thromboprophylaxis recommended by the guidelines. Extended-duration thromboprophylaxis was associated with a significantly lower risk of DVT, PE, and VTE compared with short-duration thromboprophylaxis.

Within-year variation in hospital utilization and its implications for hospital costs.

Variability in demand for hospital services may have important effects on hospital costs, but this has been difficult to examine because data on within-year variations in hospital use have not been available for large samples of hospitals. We measure daily occupancy in California hospitals and examine variation in hospital utilization at the daily level. We find substantial day-to-day variation in hospital utilization, and noticeable differences between hospitals in the amount of day-to-day variation in utilization. We examine the impact of variation on hospital costs, showing that increases in variance are associated with increases in hospital expenditures, but that the effects are qualitatively modest.