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1.
J AAPOS ; 28(2): 103854, 2024 04.
Artigo em Inglês | MEDLINE | ID: mdl-38412916

RESUMO

We present the case of a patient with a history of laser-treated retinopathy of prematurity (ROP) who developed narrow angles and intermittent angle closure. Despite laser peripheral iridotomy/iridoplasty, 1 year later, the patient had recurrent narrowing that resolved following clear lens extraction with intraocular lens placement. This case highlights the importance of continued monitoring for narrow angles in patients with ROP history.


Assuntos
Glaucoma de Ângulo Fechado , Terapia a Laser , Retinopatia da Prematuridade , Recém-Nascido , Humanos , Glaucoma de Ângulo Fechado/cirurgia , Iris/cirurgia , Retinopatia da Prematuridade/diagnóstico , Retinopatia da Prematuridade/cirurgia , Iridectomia , Pressão Intraocular
2.
Clin Ther ; 42(9): 1682-1698.e7, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32747004

RESUMO

PURPOSE: The efficacy of checkpoint inhibitor (CPI) immunotherapy in patients with non-small cell lung cancer (NSCLC) is limited by a lack of strongly predictive response markers, subjecting patients to potential underutilization of alternative effective treatments, increased risk for futile care, and unnecessary costs. Here, we characterize the extent to which basic molecular tumor-marker testing has been performed for NSCLC therapy selection in the United States, and compare medical resource utilization and costs in CPI-treated patients versus CPI-eligible patients treated with other therapies. METHODS: We identified a cohort of CPI-treated patients with NSCLC and a propensity score-matched cohort of CPI-eligible patients with NSCLC treated with non-CPI therapies (3095 patients in each group), using US administrative claims data covering the pre- and postinitial FDA-approval period for nivolumab, pembrolizumab, and atezolizumab (October 2012 to September 2017). We describe the utilization of recommended baseline molecular testing for CPI selection (pre-index date for CPI or other anticancer therapy), including programmed death ligand 1 (PD-L1) immunohistochemistry, ALK rearrangement and EGFR mutation testing, and pre- and postindex treatment patterns. All-cause medical resource utilization and semiannual total reimbursement (costs) were compared between CPI-treated and non-CPI-treated patients. FINDINGS: At baseline, in the propensity score-matched CPI- and non-CPI-treated patient cohorts, mean PD-L1 immunohistochemistry test utilization for CPI selection was moderate (0.6 vs 0.7 per patient, respectively). However, we observed much lower mean utilization of testing for EGFR mutations (0.1 vs 0.1 per patient) and ALK rearrangements (0.1 vs 0.2 per patient). Postindex, the use of both chemotherapy and ALK- and EGFR-targeted therapies were decreased in both cohorts. The CPI-treated group had significantly higher mean medical resource utilization in nearly all categories in the postindex period, and total per-patient semiannual costs, than did the CPI-eligible patients who received other therapies (141,537 vs 75,429 US dollars [USD]; P < 0.0001), driven by CPI drug reimbursement. Median (interquartile range) time on CPI was longest with pembrolizumab (113 [106-127] days), followed by nivolumab (105 [97-106] days) and atezolizumab (64 [50-85] days). Despite being associated with the lowest drug cost and the shortest treatment duration, atezolizumab was associated with the highest mean total per-patient semiannual costs (160,540 USD) compared with pembrolizumab (153,003 USD) and nivolumab (138,542 USD). IMPLICATIONS: The advent of CPI treatment for NSCLC has added substantial care-related costs for patients and payers, concurrent with underutilization of minimum recommended molecular testing for therapy selection. Broad uptake of panel-based comprehensive targeted-therapy and immunotherapy profiling can promote optimal treatment selection and sequencing, reduce the likelihood of futile treatment, and further improve patient outcomes.


Assuntos
Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Efeitos Psicossociais da Doença , Imunoterapia/economia , Neoplasias Pulmonares/tratamento farmacológico , Idoso , Anticorpos Monoclonais Humanizados/administração & dosagem , Antígeno B7-H1/imunologia , Biomarcadores Tumorais , Estudos de Coortes , Custos de Medicamentos , Humanos , Pessoa de Meia-Idade , Mutação , Nivolumabe/administração & dosagem , Estudos Retrospectivos , Estados Unidos
3.
Orthopedics ; 42(1): e86-e92, 2019 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-30484850

RESUMO

In the United States, demand for total hip arthroplasty (THA) and THA revision procedures are increasing due to an aging population, a longer life expectancy, and an increasing prevalence of osteoarthritis. This retrospective cohort study identified patients 65 years and older in the Medicare 5% Standard Analytic Files who underwent THA for osteoarthritis between January 1, 2009, and September 30, 2010. The authors estimated the 5-year cumulative revision risk (CRR) using the Kaplan-Meier method, revision-related complications, and Medicare expenditures. Using a 6.22% compound annual growth rate from the Healthcare Cost and Utilization Project of the Agency for Healthcare Research and Quality, the authors estimated the number of THAs that will be performed from 2018 to 2027 and calculated the 10-year projected savings to Medicare for a 1% reduction in CRR. Among 7820 patients, the mean age was 74.4 years, and 62.4% were female. Cumulative revision risk was 4.2% at 5 years (through September 30, 2015), with 30.8% of revisions occurring within 90 days of the THA. At least 24.4% of revision patients had a complication. Median revision inpatient stay and episode of care (through 90 days) expenditures were $23,847 and $36,157, respectively. With a 1% absolute reduction in CRR, Medicare could save $697 million over a 10-year period, or $985 million when including Medicare Advantage, which represented 29.2% of 2016 Medicare payments. Strategies to reduce the risk of THA revision, such as the use of implant constructs with lower CRR and value-based payment models, are needed to achieve Medicare payment reductions while maintaining or improving quality of care for Medicare beneficiaries. [Orthopedics. 2019; 42(1):e86-e92.].


Assuntos
Artroplastia de Quadril/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Artroplastia de Quadril/métodos , Artroplastia de Quadril/estatística & dados numéricos , Redução de Custos/métodos , Análise de Dados , Feminino , Prótese de Quadril/efeitos adversos , Humanos , Tempo de Internação/estatística & dados numéricos , Masculino , Medicare/economia , Medicare/estatística & dados numéricos , Falha de Prótese , Reoperação/economia , Reoperação/estatística & dados numéricos , Estudos Retrospectivos , Medição de Risco/métodos , Estados Unidos
4.
Dig Dis Sci ; 61(10): 2993-3006, 2016 10.
Artigo em Inglês | MEDLINE | ID: mdl-27278957

RESUMO

BACKGROUND: Colonoscopy may be one of the most frequent elective procedures in older adults and is associated with a low occurrence of complications. However, reduction of risks attributable to the bowel preparation may be achieved with the use of effective and safer products. AIM: The aim of this study was to examine the incidence of treatment-emergent adverse events (TEAEs) associated with SUPREP(®) [oral sulfate solution (OSS)] and other common prescription bowel preparations (non-OSS). METHODS: This real-world, observational study used de-identified health insurance claims and laboratory results to identify TEAEs in the 3 months following screening colonoscopy in adults with a prescription for a bowel preparation in the prior 60 days. The unadjusted and adjusted (controlling for patient risk factors) cumulative incidences of TEAEs were estimated using Kaplan-Meier and Poisson regression, respectively. RESULTS: Among patients ≥45 years, the overall cumulative incidence was significantly lower (p < 0.001) in the OSS cohort than in the non-OSS cohort (unadjusted: 2.31 vs. 2.89 %; adjusted: 1.61 vs. 1.95 %), with significantly lower acute cardiac conditions (1.56 vs. 1.90 %; p < 0.001), renal failure/other serious renal diseases (OSS: 0.21 %, non-OSS: 0.32 %; p < 0.001), and serum electrolyte abnormalities (OSS: 0.39 %, non-OSS: 0.49 %; p = 0.017). There were no significant differences between cohorts in death, seizure disorders, aggravation of gout, and ischemic colitis. Results were similar in the adjusted cumulative incidences. CONCLUSIONS: In actual use, the overall cumulative incidence of TEAEs was significantly lower in the OSS cohort, demonstrating that OSS is as safe as, or possibly safer than, non-OSS prescription bowel preparations.


Assuntos
Injúria Renal Aguda/induzido quimicamente , Arritmias Cardíacas/induzido quimicamente , Catárticos/efeitos adversos , Colonoscopia , Eletrólitos/efeitos adversos , Desequilíbrio Hidroeletrolítico/induzido quimicamente , Injúria Renal Aguda/epidemiologia , Adolescente , Adulto , Arritmias Cardíacas/epidemiologia , Colite Isquêmica/induzido quimicamente , Colite Isquêmica/epidemiologia , Neoplasias Colorretais/diagnóstico , Detecção Precoce de Câncer , Gota/induzido quimicamente , Gota/epidemiologia , Cardiopatias/induzido quimicamente , Cardiopatias/epidemiologia , Humanos , Incidência , Estimativa de Kaplan-Meier , Nefropatias/induzido quimicamente , Nefropatias/epidemiologia , Pessoa de Meia-Idade , Fosfatos/efeitos adversos , Polietilenoglicóis/efeitos adversos , Vigilância de Produtos Comercializados , Estudos Retrospectivos , Convulsões/induzido quimicamente , Convulsões/epidemiologia , Sulfatos/efeitos adversos , Desequilíbrio Hidroeletrolítico/epidemiologia , Adulto Jovem
5.
J Manag Care Spec Pharm ; 21(10): 946-54, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-26402393

RESUMO

BACKGROUND: Obesity is a serious condition affecting more than 35% of adults in the United States. In obese individuals for whom other weight control methods have been ineffective, bariatric surgery is a safe and effective method of weight control. An estimated 150,000 to 160,000 bariatric surgeries are performed in the United States yearly. Iron deficiency anemia is common in patients after bariatric surgery, with incidence rates up to 49%, and may be due to malabsorption of nutrients.  OBJECTIVES: To (a) compare the medical resource utilization (MRU)- both medical care and treatment resources-and associated costs in a sample of commercially insured adult bariatric surgery patients with and without iron deficiency anemia (IDA), and (b) describe anti-anemia treatment patterns in those bariatric surgery patients diagnosed with IDA. METHODS: Using Truven Health MarketScan claims data, bariatric surgery patients were identified by the ICD-9-CM and CPT procedure codes for bariatric surgery and classified by surgery and IDA diagnosis within 2 years of initial surgery. Intravenous (IV) iron treatment was determined by HCPCS codes, prescription oral iron by NDC numbers, and blood transfusions by CPT and ICD-9-CM codes. Clinical, MRU, and economic outcomes for all-cause health services were compared between IDA and non-IDA patients. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated using logistic regression, controlling for demographic and clinical characteristics on outcomes of complications and hospitalization. RESULTS: Of the 24,344 bariatric surgery patients analyzed, 11.6% received an IDA diagnosis 2 years after surgery (average days to diagnosis = 279). Most IDA patients (78.5%) received a test for iron in the post-index period; only 9.1% received IV iron treatment, with iron dextran (3.8%) and iron sucrose (3.4%) being the most common (average days to IV iron treatment = 403 days). Prescription oral iron was found in 4.9% of all IDA patients (average days to oral iron treatment = 476.7). Approximately 9% of IDA patients received a blood transfusion (average days to transfusion = 304.8). For the total sample, the average age was 46 years with a higher percentage of females (83.9% IDA; 78.7% non-IDA). Most clinical characteristics were similar among patients with and without IDA, except heart disease (1.3% IDA vs. 0.8% non-IDA; P = 0.005) and gallbladder disease (0.0% IDA vs. 0.2% non-IDA; P = 0.037). More IDA patients had complications after surgery (40.4% vs. 27.7%; P less than 0.001), such as nonabsorption (22.4% vs. 16.5%; P less than 0.001); digestive (15.6% vs. 10.2%; P less than 0.001); and gastrojejunal ulcer (7.6% vs. 2.0%; P less than 0.001). Multivariate results showed that IDA patients were more likely to have a bariatric surgery complication over non-IDA patients (OR = 1.367, 95% CI = 1.257-1.487; P less than 0.05). Adjusted results showed IDA patients more than twice as likely to be hospitalized (OR = 2.567, 95% CI = 2.363-2.790; P less than 0.05). Total costs were twice as much in the IDA group compared with the non-IDA group ($37,882 vs. $19,253; P less than 0.001).  CONCLUSIONS: Bariatric surgery patients who develop IDA may be subject to higher complication rates, MRU, and direct medical costs. Although most bariatric surgery patients who develop IDA are tested for iron, most are not treated with IV iron or oral iron and do not receive blood transfusions. Further research is needed to determine if IDA is a result of bariatric surgery complications or a predictor of increased MRU and costs.


Assuntos
Anemia Ferropriva/epidemiologia , Cirurgia Bariátrica , Efeitos Psicossociais da Doença , Obesidade/cirurgia , Adulto , Anemia Ferropriva/economia , Anemia Ferropriva/etiologia , Estudos de Coortes , Feminino , Custos de Cuidados de Saúde , Recursos em Saúde/estatística & dados numéricos , Hospitalização/estatística & dados numéricos , Humanos , Compostos de Ferro/uso terapêutico , Modelos Logísticos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Estados Unidos/epidemiologia
6.
Clinicoecon Outcomes Res ; 7: 123-32, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-25759590

RESUMO

BACKGROUND: Autosomal dominant polycystic kidney disease (ADPKD) results in kidney cyst development and enlargement, resulting in chronic kidney disease (CKD) leading to renal failure. This study sought to determine if ADPKD patients in the early stages of CKD contribute to a sizable economic burden for the US health care system. METHODS: This was a retrospective, matched cohort study, reviewing medical resource utilization (MRU) and costs for adults in a US private-payer claims database with a diagnosis code of ADPKD (ICD-9-CM 753.13). ADPKD patients were matched by age grouping (0-17, 18-34, 35-44, 45-54, 55-64, and 65+ years) and sex to controls to understand the burden of ADPKD. Descriptive statistics on 6-month MRU and costs were assessed by CKD stages, dialysis use, or previous renal transplant. RESULTS: The analysis included ADPKD patients in CKD stages 1-5 (n=316 to n=860), dialysis (n=586), and post-transplant (n=615). Mean ages did not differ across CKD stages (range 43-56 years). Men were the majority in the later stages but the minority in the early stages. The proportion of patients with at least one hospitalization increased with CKD stage, (12% to >40% CKD stage 2 to stage 5, dialysis or post-transplant). The majority had at least one hospital outpatient visit and at least one pharmacy claim. Total 6-month per-patient costs were greater among ADPKD patients than in age-matched and sex-matched healthy non-ADPKD controls (P<0.001 for all comparisons). CONCLUSION: ADPKD patients with normal kidney function are associated with a significant economic burden to the health care system relative to the general population. Any treatments that delay progression to later stages of CKD may provide potential health care cost offsets.

7.
Clinicoecon Outcomes Res ; 6: 283-96, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24904218

RESUMO

INTRODUCTION: Low back pain is common and treatment costly with substantial lost productivity and lost wages in the working-age population. Chronic low back pain originating in the sacroiliac (SI) joint (15%-30% of cases) is commonly treated with nonoperative care, but new minimally invasive surgery (MIS) options are also effective in treating SI joint disruption. We assessed whether the higher initial MIS SI joint fusion procedure costs were offset by decreased nonoperative care costs from a US commercial payer perspective. METHODS: An economic model compared the costs of treating SI joint disruption with either MIS SI joint fusion or continued nonoperative care. Nonoperative care costs (diagnostic testing, treatment, follow-up, and retail pharmacy pain medication) were from a retrospective study of Truven Health MarketScan(®) data. MIS fusion costs were based on the Premier's Perspective™ Comparative Database and professional fees on 2012 Medicare payment for Current Procedural Terminology code 27280. RESULTS: The cumulative 3-year (base-case analysis) and 5-year (sensitivity analysis) differentials in commercial insurance payments (cost of nonoperative care minus cost of MIS) were $14,545 and $6,137 per patient, respectively (2012 US dollars). Cost neutrality was achieved at 6 years; MIS costs accrued largely in year 1 whereas nonoperative care costs accrued over time with 92% of up front MIS procedure costs offset by year 5. For patients with lumbar spinal fusion, cost neutrality was achieved in year 1. CONCLUSION: Cost offsets from new interventions for chronic conditions such as MIS SI joint fusion accrue over time. Higher initial procedure costs for MIS were largely offset by decreased nonoperative care costs over a 5-year time horizon. Optimizing effective resource use in both nonoperative and operative patients will facilitate cost-effective health care delivery. The impact of SI joint disruption on direct and indirect costs to commercial insurers, health plan beneficiaries, and employers warrants further consideration.

8.
Clinicoecon Outcomes Res ; 6: 63-74, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24596468

RESUMO

INTRODUCTION: Low back pain is common and originates in the sacroiliac (SI) joint in 15%-30% of cases. Traditional SI joint disruption/degenerative sacroiliitis treatments include nonoperative care or open SI joint fusion. To evaluate the usefulness of newly developed minimally-invasive technologies, the costs of traditional treatments must be better understood. We assessed the costs of nonoperative care for SI joint disruption to commercial payers in the United States (US). METHODS: A retrospective study of claim-level medical resource use and associated costs used the MarketScan® Commercial Claims and Encounters as well as Medicare Supplemental Databases of Truven Healthcare. Patients with a primary ICD-9-CM diagnosis code for SI joint disruption (720.2, 724.6, 739.4, 846.9, or 847.3), an initial date of diagnosis from January 1, 2005 to December 31, 2007 (index date), and continuous enrollment for ≥1 year before and 3 years after the index date were included. Claims attributable to SI joint disruption with a primary or secondary ICD-9-CM diagnosis code of 71x.xx, 72x.xx, 73x.xx, or 84x.xx were identified; the 3-year medical resource use-associated reimbursement and outpatient pain medication costs (measured in 2011 US dollars) were tabulated across practice settings. A subgroup analysis was performed among patients with lumbar spinal fusion. RESULTS: The mean 3-year direct, attributable medical costs were $16,196 (standard deviation [SD] $28,592) per privately-insured patient (N=78,533). Among patients with lumbar spinal fusion (N=434), attributable 3-year mean costs were $91,720 (SD $75,502) per patient compared to $15,776 (SD $27,542) per patient among patients without lumbar spinal fusion (N=78,099). Overall, inpatient hospitalizations (19.4%), hospital outpatient visits and procedures (14.0%), and outpatient pain medications (9.6%) accounted for the largest proportion of costs. The estimated 3-year insurance payments attributable to SI joint disruption were $1.6 billion per 100,000 commercial payer beneficiaries. CONCLUSION: The economic burden of SI joint disruption among privately-insured patients in the US is substantial, highlighting the need for more cost-effective therapies.

9.
Clinicoecon Outcomes Res ; 5: 575-87, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-24348055

RESUMO

INTRODUCTION: The economic burden associated with the treatment of low back pain (LBP) in the United States is significant. LBP caused by sacroiliac (SI) joint disruption/degenerative sacroiliitis is most commonly treated with nonoperative care and/or open SI joint surgery. New and effective minimally invasive surgery (MIS) options may offer potential cost savings to Medicare. METHODS: An economic model was developed to compare the costs of MIS treatment to nonoperative care for the treatment of SI joint disruption in the hospital inpatient setting in the US Medicare population. Lifetime cost savings (2012 US dollars) were estimated from the published literature and claims data. Costs included treatment, follow-up, diagnostic testing, and retail pharmacy pain medication. Costs of SI joint disruption patients managed with nonoperative care were estimated from the 2005-2010 Medicare 5% Standard Analytic Files using primary International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes 720.2, 724.6, 739.4, 846.9, or 847.3. MIS fusion hospitalization cost was based on Diagnosis Related Group (DRG) payments of $46,700 (with major complications - DRG 459) and $27,800 (without major complications - DRG 460), weighted assuming 3.8% of patients have complications. MIS fusion professional fee was determined from the 2012 Medicare payment for Current Procedural Terminology code 27280, with an 82% fusion success rate and 1.8% revision rate. Outcomes were discounted by 3.0% per annum. RESULTS: The extrapolated lifetime cost of treating Medicare patients with MIS fusion was $48,185/patient compared to $51,543/patient for nonoperative care, resulting in a $660 million savings to Medicare (196,452 beneficiaries at $3,358 in savings/patient). Including those with ICD-9-CM code 721.3 (lumbosacral spondylosis) increased lifetime cost estimates (up to 478,764 beneficiaries at $8,692 in savings/patient). CONCLUSION: Treating Medicare beneficiaries with MIS fusion in the hospital inpatient setting could save Medicare $660 million over patients' lifetimes.

10.
Clinicoecon Outcomes Res ; 5: 171-80, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23637545

RESUMO

BACKGROUND: Fibromyalgia (FM) is a chronic disorder characterized by widespread, persistent pain. Prospective and retrospective studies have demonstrated substantial health-care costs associated with FM in a number of countries. This study evaluated and compared health-resource use (HRU) and associated costs related to FM in routine clinical practice across the US, France, and Germany. METHODS: Two separate, cross-sectional, observational studies of subjects with FM were conducted: one in the US and one in France and Germany. HRU related to prescription medication, physician office visits, diagnostic tests, and hospitalizations was abstracted from chart review; patient out-of-pocket costs and lost productivity were collected via subject self-report. Costs were assigned to HRU based on standard algorithms. Direct and indirect costs were evaluated and compared by simple linear regression. RESULTS: A total of 442 subjects (203 US, 70 France, 169 Germany) with FM were analyzed. The mean (standard deviation) age in the US, France, and Germany was 47.9 (10.9), 51.2 (9.5), and 49.2 (9.8), respectively (P = 0.085). Most subjects were female (95% US, 83% France, 80% Germany) (P < 0.001). Adjusted annual direct costs per subject for FM were significantly higher in the US ($7087) than in France ($481, P < 0.001) or Germany ($2417, P < 0.001). Adjusted mean annual indirect costs per subject for FM were lower in the US ($6431) than in France ($8718) or Germany ($10,001), but represented a significant proportion of total costs in all countries. CONCLUSION: The significant HRU and costs associated with FM in the US, France, and Germany documented in this study highlight the substantial global economic burden of FM. Indirect costs represented a significant proportion of the total costs, particularly in Europe. Comparisons between the three countries show differences in HRU, with significantly higher direct costs in the US compared with France and Germany.

11.
Biochim Biophys Acta ; 1830(6): 3489-96, 2013 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-23434438

RESUMO

BACKGROUND: Tissue factor (TF), an in vivo initiator of blood coagulation, is a transmembrane protein and has two disulfides in the extracellular domain. The integrity of one cysteine pair, Cys186-Cys209, has been hypothesized to be essential for an allosteric "decryption" phenomenon, presumably regulating TF procoagulant function, which has been the subject of a lengthy debate. The conclusions of published studies on this subject are based on indirect evidences obtained by the use of reagents with potentially oxidizing/reducing properties. METHODS: The status of disulfides in recombinant TF1-263 and natural placental TF in their non-reduced native and reduced forms was determined by mass-spectrometry. Functional assays were performed to assess TF cofactor function. RESULTS: In native proteins, all four cysteines of the extracellular domain of TF are oxidized. Reduced TF retains factor VIIa binding capacity but completely loses the cofactor function. CONCLUSION: The reduction of TF disulfides (with or without alkylation) eliminates TF regulation of factor VIIa catalytic function in both membrane dependent FX activation and membrane independent synthetic substrate hydrolysis. GENERAL SIGNIFICANCE: Results of this study advance our knowledge on TF structure/function relationships.


Assuntos
Apoenzimas/química , Dissulfetos/química , Tromboplastina/química , Regulação Alostérica/fisiologia , Apoenzimas/metabolismo , Coagulação Sanguínea/fisiologia , Coenzimas/química , Coenzimas/metabolismo , Dissulfetos/metabolismo , Fator VIIa/química , Fator VIIa/metabolismo , Fator X/química , Fator X/metabolismo , Humanos , Oxirredução , Proteínas da Gravidez/química , Proteínas da Gravidez/metabolismo , Estrutura Terciária de Proteína , Proteínas Recombinantes/química , Proteínas Recombinantes/metabolismo , Relação Estrutura-Atividade , Tromboplastina/metabolismo
12.
BMC Musculoskelet Disord ; 13: 22, 2012 Feb 17.
Artigo em Inglês | MEDLINE | ID: mdl-22340435

RESUMO

BACKGROUND: Patients with fibromyalgia (FM) report widespread pain, fatigue, and other functional limitations. This study aimed to provide an assessment of the burden of illness associated with FM in France and its association with disease severity and core domains as defined by Outcome Measures in Rheumatology Clinical Trials (OMERACT) for FM. METHODS: This cross-sectional, observational study recruited patients with a prior diagnosis of FM from 18 community-based physician offices in France. Patients completed questions about FM impact (Fibromyalgia-Impact Questionnaire [FIQ]), core symptoms (defined by OMERACT), health-related quality of life (EQ-5D), current overall health status (rated on a scale from 0 to 100), productivity, treatment satisfaction, and out-of-pocket expenses related to FM. Site staff recorded patients' treatment and health resource use based on medical record review. Costs were extrapolated from 4-week patient-reported data and 3-month clinical case report form data and calculated in 2008 Euros using a societal perspective. Tests of significance used the Kruskal-Wallis test or Fisher's Exact test where P < 0.05 was considered significant. RESULTS: Eighty-eight patients (mean 55.2 y; female:male 74:14) were recruited. The majority of patients (84.1%) were prescribed medications for FM. Patients mainly described medications as a little/not at all effective (40.0%) or somewhat effective (52.9%). Current Overall Health rating was 52.9 (± 17.8) and FIQ total score was 54.8 (± 17.3). FIQ total score was used to define FM severity, and 17 patients scored 0- < 39 (mild FM), 33 patients 39- < 59 (moderate FM), and 38 scored 59-100 (severe FM). As FM severity level worsened, patients had poorer overall health status and perceived their prescription medications to be less effective. Average cost/FM patient was higher for severe (€10,087) vs. moderate (€6,633) or mild FM (€5,473); however, the difference was not significant. CONCLUSIONS: In a sample of 88 patients with FM from France, we found that FM poses a substantial economic and human burden on patients and society. FM severity level was significantly associated with patients' health status and core symptom domains.


Assuntos
Efeitos Psicossociais da Doença , Fibromialgia/economia , Fibromialgia/psicologia , Custos de Cuidados de Saúde/tendências , Avaliação de Resultados em Cuidados de Saúde/normas , Índice de Gravidade de Doença , Inquéritos e Questionários/normas , Analgésicos/uso terapêutico , Estudos Transversais , Avaliação da Deficiência , Feminino , Fibromialgia/tratamento farmacológico , França/epidemiologia , Nível de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde/tendências , Satisfação do Paciente , Licença Médica/economia
13.
J Manag Care Pharm ; 16(8): 605-15, 2010 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-20866165

RESUMO

BACKGROUND: Anemia in patients with chronic kidney disease (CKD) is associated with increased morbidity and mortality, decreased quality of life, and substantial health care costs. Iron therapy is recommended, usually in combination with an erythropoiesis-stimulating agent (ESA), in many CKD patients with anemia and low iron levels to raise hemoglobin levels to a range of 10 to 12 grams per deciliter; iron deficiency is defined by a ferritin score less than 100 micrograms (mcg) per liter and transferrin saturation (TSAT) less than 20%. OBJECTIVE: To examine the use of intravenous (IV) iron and its associated economic and clinical outcomes in Medicare beneficiaries with stage 3 or stage 4 CKD and anemia. METHODS: This was a retrospective cohort analysis using 2006 and 2007 Medicare 5% Standard Analytic Files (SAF). Use of therapy with IV iron and/or ESAs was identified among patients diagnosed with CKD and anemia. The study index quarter was the first quarter in 2006 during which the patient had primary or secondary diagnoses of both CKD and anemia. Based on the receipt of IV iron or ESA treatment in the index quarter, patients were classified into 1 of 4 treatment groups: IV iron and ESA; IV iron without ESA; ESA without IV iron; neither IV iron nor ESA. Therapy with oral iron was not measurable with this database. Clinical and economic outcomes, including the progression to advanced CKD stages, development of anemia, mortality, hospitalization, and net Medicare reimbursement (i.e., not including patient or supplemental plan contribution) for all-cause health care services, were examined for 1 year following the index quarter. Between-group differences were tested using Pearson chi-square for categorical variables and the Kruskal-Wallis nonparametric test for reimbursement. Multivariate logistic regression models were estimated to assess the associations of mortality, inpatient hospitalization, skilled nursing facility (SNF) admission, and hospice care with treatment regimen, controlling for patient demographic and clinical characteristics. RESULTS: Of the 4,310 study patients with both CKD and anemia, 2,913 (67.6%) received neither IV iron nor ESA; 984 (22.8%) received ESA without IV iron; 277 (6.4%) received IV iron and ESA; and 136 (3.2%) received IV iron without ESA in the index quarter. Logistic regression analyses showed that patients receiving neither IV iron nor ESA (reference group) were at increased risk of death compared with patients receiving both IV iron and ESA (OR = 0.62, 95% CI = 0.42-0.90). Additionally, patients receiving neither IV iron nor ESA were more likely to be hospitalized compared with patients receiving both IV iron and ESA (OR = 0.66, 95% CI = 0.50-0.87), IV iron without ESA (OR = 0.55, 95% CI = 0.38-0.79), and ESA without IV iron (OR = 0.73, 95% CI = 0.62-0.87). Further, patients not receiving IV iron or ESA were more likely to be admitted to an SNF than patients receiving both IV iron and ESA (OR = 0.44, 95% CI = 0.32-0.61), IV iron without ESA (OR = 0.57, 95% CI = 0.36-0.88), and ESA without IV iron (OR = 0.56, 95% CI = 0.47-0.67). Patients receiving neither IV iron nor ESA in the index quarter had the highest mean [SD] total Medicare reimbursement per patient in the subsequent year ($42,353 [$52,887]) compared with patients receiving IV iron without ESA ($28,654 [$32,068]), IV iron and ESA ($34,152 [$30,506]), or ESA without IV iron ($38,172 [$35,591], P = 0.001). CONCLUSIONS: Use rates of IV iron and ESA in a sample of Medicare enrollees with CKD and anemia in 2006 suggest that anemia management therapies may be underutilized; however, oral iron therapy use was not measurable with the study database, and therapies initiated after the index quarter were not measured. Patients not treated with IV iron or ESA had significantly higher rates of hospitalization and SNF admission than patients treated with either IV iron or ESA. Further, mortality was significantly higher in patients receiving neither IV iron nor ESA than in patients who received IV iron and ESA. Additionally, total all-cause health care costs were higher among patients receiving neither IV iron nor ESA treatment compared with patients treated with IV iron and/or ESA.


Assuntos
Anemia/economia , Anemia/terapia , Hematínicos/uso terapêutico , Compostos de Ferro/uso terapêutico , Falência Renal Crônica/economia , Falência Renal Crônica/terapia , Medicare/economia , Adulto , Idoso , Anemia/complicações , Determinação de Ponto Final , Feminino , Hematínicos/administração & dosagem , Humanos , Injeções Intravenosas , Compostos de Ferro/administração & dosagem , Falência Renal Crônica/complicações , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento , Estados Unidos , Adulto Jovem
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