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1.
Defecography is used to investigate patients with defecation disorders, especially obstructed defecation and anal incontinence. We studied 73 consecutive patients who complained of difficult defecation, anal incontinence, or idiopathic anorectal pain. The following defecographic parameters were recorded and compared in different patient groups: anorectal angulation, pelvic floor descent, formation of rectocele, and rectal invagination. Increasing number of childbirths correlated with pelvic floor descent in defecograms (r= 0.319, p< 0.05). There were no significant differences in defecographic parameters in patients with obstructed defecation, anal incontinence, or idiopathic anorectal pain. Thus, we conclude that defecography may be useful as an investigative tool in clinical research of defecation disorders, but it is of minor value in clinical diagnosis and decision-making.  相似文献   

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Background: Mitral regurgitation (MR) is a common valvular heart disorder requiring intervention once it becomes severe. Transcatheter mitral repair with the MitraClip device is a safe and effective therapy for selected patients denied surgery. The authors sought to evaluate the clinical outcomes and economic impact of this therapy compared to medical management in heart-failure patients with symptomatic mitral regurgitation.

Methods and results: The study was comprised of two phases; an observational study of patients with heart failure and mitral regurgitation treated with either medical therapy or the MitraClip, and an economic model. Results of the observational study were used to estimate parameters for the decision model, which estimated costs, and benefits in a hypothetical cohort of patients with heart failure and moderate-to-severe mitral regurgitation treated with either standard medical therapy or MitraClip. The cohort of patients treated with the MitraClip was propensity matched to a population of heart failure patients, and their outcomes compared. At a mean follow-up of 22 months, all-cause mortality was 21% in the MitraClip cohort and 42% in the medical management cohort (p?=?.007). The decision model demonstrated that MitraClip increased life expectancy from 1.87–3.60 years and quality-adjusted life years (QALY) from 1.13–2.76 years. The incremental cost was $52,500 Canadian dollars, corresponding to an incremental cost-effectiveness ratio (ICER) of $32,300.00 per QALY gained. Results were sensitive to the survival benefit.

Conclusion: In heart failure patients with symptomatic moderate–severe mitral regurgitation, therapy with the MitraClip is associated with superior survival and is cost-effective compared to medical therapy.  相似文献   

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Abstract

Aims: To describe the incidence and identify prognostic factors of central nervous system (CNS) adverse events (AEs) and any AEs (CNS, skin rash, or fracture) and evaluate the healthcare resource utilization (HCRU), direct medical costs, and therapy discontinuation associated with these AEs among non-metastatic prostate cancer (nmPC) patients who received secondary hormone therapies.

Methods and results: nmPC patients who had initiated secondary hormonal therapy with enzalutamide, bicalutamide, or abiraterone ≥1?year after androgen deprivation therapy (ADT) were identified in the MarketScan database. Survival analyses were used to describe the incidence of CNS or any AEs. Annual HCRU and costs were compared across patient groups (CNS AE vs no CNS AE; any AE vs no AE) using propensity score weighted generalized linear models. Multivariate Cox proportional hazards models were used to identify AE predictors and compare risks of discontinuation.

Results: The analysis included 532 patients who initiated secondary hormonal therapies, among whom 201 (38%) and 244 (46%) experienced a CNS AE and any AE, respectively. Median times to CNS AE and any AE from therapy initiation were 17.90 and 11.00?months, respectively. Predictors of any AE were any AE in the baseline period (≤6?months before starting therapy), Charlson Comorbidity Index (CCI) score (1 vs 0), surgical castration, and older age. Predictors of CNS AEs were CNS AE in the baseline period and CCI score (1 vs 0). CNS and any AEs were associated with significantly higher HCRU. CNS AEs were associated with significantly higher incremental total medical costs ($18,522). CNS AEs and any AEs significantly increased therapy discontinuation risk by 48% and 38%, respectively.

Conclusions: AEs increase the economic burden and therapy discontinuation among nmPC patients receiving secondary hormonal therapies subsequent to ADTs. These patients should be carefully evaluated for AEs to reduce therapy discontinuation, HCRU, and direct medical costs.  相似文献   

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Abstract

Objective: To estimate the incremental cost per quality-adjusted life-years (QALYs) for abatacept and rituximab, in combination with methotrexate, relative to methotrexate alone in patients with active rheumatoid arthritis (RA).

Methods: A patient-level simulation model was used to depict the progression of functional disability over the lifetimes of women aged 55–64 years with active RA and inadequate response to a tumor necrosis factor (TNF)-α antagonist therapy. Future health-state utilities and medical care costs were based on projected values of the Health Assessment Questionnaire Disability Index (HAQ-DI). Patients were assumed to receive abatacept or rituximab in combination with methotrexate until death or therapy discontinuation due to lack of efficacy or adverse events. HAQ-DI improvement at month 6, after adjustments for control drug (methotrexate) response, was derived from two clinical trials. Costs of medical care and biologic drugs, discounted at 3% annually, were from the perspective of a US third-party payer and expressed in 2007 US dollars.

Results: Relative to methotrexate alone, abatacept/methotrexate and rituximab/methotrexate therapies were estimated to yield an average of 1.25 and 1.10 additional QALYs per patient, at mean incremental costs of $58,989 and $60,380, respectively. The incremental cost-utility ratio relative to methotrexate was $47,191 (95% CI $44,810–49,920) per QALY gained for abatacept/methotrexate and $54,891 (95% CI $52,274–58,073) per QALY gained for rituximab/methotrexate. At an acceptability threshold of $50,000 per QALY, the probability of cost effectiveness was 90% for abatacept and 0.0% for rituximab.

Conclusion: Abatacept was estimated to be more cost effective than rituximab for use in RA from a US third-party payer perspective. However, head-to-head clinical trials and long-term observational data are needed to confirm these findings.  相似文献   

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Aims: To analyze the association between provider, healthcare costs, and glycemic control for patients with diabetes mellitus (DM).

Materials and methods: This cross-sectional study identified adults with type 1 or 2?DM (T1D, T2D) in the Optum database. The main independent variable was provider (endocrinologist or primary care). Regression analysis compared total medical and pharmacy costs, adjusting for health status and other patient differences, by provider.

Results: For all patients, HbA1C improvement was greater, and medical costs significantly lower with an endocrinologist rather than a primary care provider. The largest HbA1C improvement (4%) occurred for insulin-dependent patients seen by endocrinologists. Significant medical savings with endocrinologist management occurred within the Medicare Advantage population in every sub-group of patients, with 14% lower costs ($4,767) for patients with T1D, 11% lower costs ($3,160) for patients with macro- and microvascular complications, and 10% lower costs ($2,237) for insulin-dependent patients. Within the commercial insurance population, medical costs were reduced by ≥9% in every sub-group of patients, with a 20% reduction ($8,450) for patients with micro- and macrovascular complications. Overall total costs (medical and pharmacy) were 8% ($1,541) higher for patients receiving endocrinologist rather than primary care, although endocrinologist care resulted in a 9% reduction (–$3,710) in costs for Medicare Advantage patients with T1D. Total medical costs (excluding pharmacy costs) may be a more accurate indicator of costs associated with patients in various stages of DM.

Limitations: There was insufficient data to develop risk-adjustment payments for pharmacy costs based on disease severity. The cross-sectional design identifies associations and not cause–effect relationships.

Conclusion: DM management by an endocrinologist was associated with greater HbA1C improvement and significantly lower medical costs. Total costs were higher with an endocrinologist, but for patients with T1D lower costs were seen, ranging from 2–9% regardless of insurance type.  相似文献   

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Abstract

Objectives:

There is a paucity of recent data on breast cancer costs, particularly on the burden of chemotherapy. The present study was designed to estimate resource use and costs associated with the current standard of care for adjuvant chemotherapy for breast cancer.

Methods:

Costs and resource use were assessed by retrospective analysis of medical records at a single comprehensive cancer care center, Hôpital Tenon, Paris, France. Data were extracted from files of female patients having undergone surgical resection of breast cancer between January–July 2010. Patients were included if they received chemotherapy at the hospital and had medical records available. Patients were followed from the start of adjuvant chemotherapy (including pre-chemotherapy) to the end of treatment. Costs were collected for each resource use item from a societal perspective using standard, published sources and expressed in 2011 Euros (€). Limitations of the analysis included the single-center study design and the use of pre-defined questionnaires on resource use (which may conservatively estimate costs).

Results:

A total of 62 patients were included in the study with a mean age of ~54 years. Most patients had stage II (50.8%) or stage III (40.7%) disease. Anthracycline plus taxane-based chemotherapy regimens were most commonly prescribed (77% of patients). Mean cost of adjuvant chemotherapy was estimated to be ~€15,740 per patient from a societal perspective. The acquisition costs of chemotherapy agents were responsible for 26% of the total, with lost productivity (27%), chemotherapy administration (19%), and adverse events (16%) also contributing substantially.

Conclusions:

Evaluation of costs in patients with non-metastatic breast cancer in France has shown that the costs of adjuvant chemotherapy are substantial. The main components of total cost were the cost of chemotherapy agents, lost productivity, chemotherapy administration, and management and prevention of adverse events.  相似文献   

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Objective: To evaluate medical resource utilization (MRU) and associated costs among Australian patients with genotype 1 chronic hepatitis C (GT1 CHC), including both untreated patients and those receiving treatment with first-generation protease inhibitor-based regimens (telaprevir, boceprevir with pegylated interferon and ribavirin).

Methods: Medical records were reviewed for a stratified random sample of GT1 CHC patients first attending two liver clinics between 2011–2013 (principal population; PP), supplemented by all GT1 CHC patients attending one transplant clinic in the same period (transplant population; TP). CHC-related MRU and associated costs are reported for the PP by treatment status (treated/not treated) stratified by baseline fibrosis grade; and for the TP for the pre-transplant, year of transplant and post-transplant periods.

Results: A total 1636 patients were screened and 590 patients (36.1%) were included. Comprehensive MRU data were collected for 276 PP patients (F0–1 n?=?59, F2 n?=?58, F3 n?=?53, F4 n?=?106; mean follow-up?=?17.3 months). Thirty-eight (13.8%) were treatment-experienced prior to enrolment; 55 (19.9%) received triple therapy during the study. Data were collected for 112 TP patients (mean follow-up?=?29.9 months), 33 (29.5%) received a transplant during the study, and 51 (45.5%) beforehand. The annual direct medical costs, excluding drug costs, were higher among treated PP vs untreated PP (AU$: $1,954 vs $1,202); and year of transplant TP vs pre-/post-transplant TP (AU$: pre-transplant $32,407, transplant $155,138, post-transplant $7,358).

Limitations: To aid interpretation of results, note that only patients with GT1 CHC who are actively managed are included, and MRU data were collected specifically from liver outpatient clinics. That said, movement of patients between hospitals is rare, and any uncaptured MRU is expected to be minimal.

Conclusions: CHC-related MRU increases substantially with disease severity. These real-world MRU data for GT1 CHC will be valuable in assessing the impact of new hepatitis C treatments.  相似文献   

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Objective: Compared to medical therapy alone, percutaneous closure of patent foramen ovale (PFO) further reduces risk of recurrent ischemic strokes in carefully selected young to middle-aged patients with a recent cryptogenic ischemic stroke. The objective of this study was to evaluate the cost-effectiveness of this therapy in the context of the United Kingdom (UK) healthcare system.

Methods: A Markov cohort model consisting of four health states (Stable after index stroke, Post-Minor Recurrent Stroke, Post-Moderate Recurrent Stroke, and Death) was developed to simulate the economic outcomes of device-based PFO closure compared to medical therapy. Recurrent stroke event rates were extracted from a randomized clinical trial (RESPECT) with a median of 5.9-year follow-up. Health utilities and costs were obtained from published sources. One-way and probabilistic sensitivity analyses (PSA) were performed to assess robustness. The model was discounted at 3.5% and reported in 2016 Pounds Sterling.

Results: Compared with medical therapy alone and using a willingness-to-pay (WTP) threshold of £20,000, PFO closure reached cost-effectiveness at 4.2 years. Cost-effectiveness ratios (ICERs) at 4, 10, and 20 years were ?20,951, ?6,887, and ?2,158, respectively. PFO closure was cost-effective for 89% of PSA iterations at year 10. Sensitivity analyses showed that the model was robust.

Conclusions: Considering the UK healthcare system perspective, percutaneous PFO closure in cryptogenic ischemic stroke patients is a cost-effective stroke prevention strategy compared to medical therapy alone. Its cost-effectiveness was driven by substantial reduction in recurrent strokes and patients’ improved health-related quality-of-life.  相似文献   

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Abstract

Aims: To evaluate the cost-effectiveness of percutaneous patent foramen ovale (PFO) closure, from a US payer perspective. Lower rates of recurrent ischemic stroke have been documented following percutaneous PFO closure in properly selected patients. Stroke in patients aged <60?years is particularly interesting because this population is typically at peak economic productivity and vulnerable to prolonged disability.

Materials and methods: A Markov model comprising six health states (Stable after index stroke, Transient ischemic attack, Post-Transient Ischemic Attack, Clinical ischemic stroke, Post-clinical ischemic stroke, and Death) was constructed to evaluate the cost-effectiveness of PFO closure in combination with medical management versus medical management alone. The base-case model employed a 5-year time-horizon, with transition probabilities, clinical inputs, costs, and utility values ascertained from published and national costing sources. Incremental cost-effectiveness ratio (ICER) was evaluated per US guidelines, utilizing a discount rate of 3.0%.

Results: At 5?years, overall costs and quality-adjusted life-years (QALYs) obtained from PFO closure compared with medical management were $16,323 vs $7,670 and 4.18 vs 3.77, respectively. At 5?years, PFO closure achieved an ICER of $21,049, beneficially lower than the conventional threshold of $50,000. PFO closure reached cost-effectiveness at 2.3?years (ICER = $47,145). Applying discount rates of 0% and 6% had a negligible impact on base-case model findings. Furthermore, PFO closure was 95.4% likely to be cost-effective, with a willingness-to-pay (WTP) threshold of $50,000 and a 5-year time horizon.

Limitations: From a cost perspective, our economic model employed a US patient sub-population, so cost data may not extrapolate to other non-US stroke populations.

Conclusion: Percutaneous PFO closure plus medical management represents a cost-effective approach for lowering the risk of recurrent stroke compared with medical management alone.  相似文献   

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Summary

Objective:

This study aims to compute the budget impact of lacosamide, a new adjunctive therapy for partial-onset seizures in epilepsy patients from 16 years of age who are uncontrolled and having previously used at least three anti-epileptic drugs from a Belgian healthcare payer perspective.

Methods:

The budget impact analysis compared the ‘world with lacosamide’ to the ‘world without lacosamide’ and calculated how a change in the mix of anti-epileptic drugs used to treat uncontrolled epilepsy would impact drug spending from 2008 to 2013. Data on the number of patients and on the market shares of anti-epileptic drugs were taken from Belgian sources and from the literature. Unit costs of anti-epileptic drugs originated from Belgian sources. The budget impact was calculated from two scenarios about the market uptake of lacosamide.

Results:

The Belgian target population is expected to increase from 5333 patients in 2008 to 5522 patients in 2013. Assuming that the market share of lacosamide increases linearly over time and is taken evenly from all other anti-epileptic drugs (AEDs), the budget impact of adopting adjunctive therapy with lacosamide increases from €5249 (0.1% of reference drug budget) in 2008 to €242,700 (4.7% of reference drug budget) in 2013. Assuming that 10% of patients use standard AED therapy plus lacosamide, the budget impact of adopting adjunctive therapy with lacosamide is around €800,000–900,000 per year (or 16.7% of the reference drug budget).

Conclusions:

Adjunctive therapy with lacosamide would raise drug spending for this patient population by as much as 16.7% per year. However, this budget impact analysis did not consider the fact that lacosamide reduces costs of seizure management and withdrawal. The literature suggests that, if savings in other healthcare costs are taken into account, adjunctive therapy with lacosamide may be cost saving.  相似文献   

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Abstract

Objective:

This study was designed to compare the burden of illness (BOI) in patients at high risk versus low risk of developing a major cardiovascular (CV) event.

Methods:

This retrospective claims data analysis included commercial health plan members identified with a primary diagnosis on a medical claim for cardiovascular disease (CVD) from January 1, 2001 through December 31, 2002. Patients were categorized as: low risk (LR), high risk (HR), or high risk aged ≥55 (HR55), based on the ONTARGET clinical trial.

Results:

Most patients (85%) were in the LR category (8% in HR55, 7% in HR). A significantly greater proportion of patients in the HR55 group were hospitalized and experienced a greater number of ambulatory visits compared with LR and HR patients. Controlling for covariates, HR55 patients averaged $22,502 in paid healthcare services over 2 years versus $15,645 for HR patients and $11,423 for LR patients (p?<?0.001). CV-related costs represented about 46% of costs for the HR55 group, versus 41% for the HR group and 31% for the LR group.

Limitations:

Claims data are collected for the purpose of payment and not research and the presence of a diagnosis code is not proof of disease, due to possible coding errors or the use of a rule-out criterion. Also, patients who died in the follow-up were not included in the analyses, resulting in lower BOI estimates. Finally, the results of this study reflect treatment of CVD in managed-care settings, and may not be applicable to a different type of population.

Conclusion:

This study demonstrates the high BOI associated with CVD, especially for patients within the high-risk group aged ≥55 years. Opportunities exist for reducing costs in this population.  相似文献   

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Objective:

Molecular monitoring of chronic myeloid leukemia (CML) has been associated with improved clinical outcomes during tyrosine kinase inhibitor therapy (TKI), yet recent studies have demonstrated its use is far below published guidelines. This study sought to determine frequencies of molecular monitoring and its impact on resource utilization and medical costs.

Methods:

A retrospective US claims administrative database (IMS LifeLink Health Plan Claims and Truven Health Analytics MarketScan databases, 11/2007–06/2012) was used to analyze the economic impact of qPCR testing in CML patients on first-line TKIs during the initial 12-months of treatment.

Results:

One thousand two hundred and five adult CML patients met the sample selection criteria. Among these, 41.0% had no qPCR tests, 31.9% had 1–2 tests, and 27.1% had 3–4 tests; 88.9% were initiated on imatinib; 47.7% were female. Patients in the 3–4 tests cohort incurred 44% (p?p?=?0.005) lower for the 3–4 tests cohort than the 0-tests cohort. Adjusted progression-related IP cost was $4132 (p?=?0.013) lower for the 3–4 tests cohort than the 0-tests cohort. Adjusted medical service cost was $5997 (p?=?0.049) lower for the 3–4 tests cohort than the 0-tests cohort.

Limitations:

Claims databases did not include information on the primary cause of hospitalizations.

Conclusions:

Among CML patients in two large claims databases, nearly three-quarters did not receive adequate molecular monitoring per published guidelines. Those who were more frequently monitored incurred lower medical service costs, with the majority of the difference in costs being related to disease progression. These findings underscore the clinical and economic values of molecular monitoring in CML.  相似文献   

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Summary

Results from a large, randomised clinical trial demonstrated reduced rates of hospitalisation and mortality, and reduced length of stay associated with valsartan added to the usual care of heart failure patients not currently receiving angiotensin-converting enzyme inhibitors (ACEIs). These results were used in a budget impact model for a large US health plan. Administrative claims data were used to estimate cost savings over 1 year. In the study health plan, 63,218 patients were identified with heart failure, with 55% not currently receiving ACEI or valsartan. Using health plan-specific cost data, care for the untreated heart failure patients with valsartan would reduce hospitalisation costs from $135 million to $43 million owing to averted heart failure-related hospitalisations and shortened length of stay for the remaining hospitalisations. Economic effects of other aspects of treatment with valsartan (e.g. outpatient or physician visits or adverse events) were not considered. Taking into account only hospitalisations and the costs of valsartan therapy, net savings in the study health plan would be expected to be $64 million.  相似文献   

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Objective:

To describe dosing patterns and to compare the drug costs per month spent in progression-free survival (PFS) among patients with advanced renal cell carcinoma (aRCC) treated with everolimus or axitinib following a first tyrosine kinase inhibitor (TKI).

Methods:

A medical record retrospective review was conducted among medical oncologists and hematologists/oncologists in the US. Patient eligibility criteria included: (1) age ≥18 years; (2) discontinuation of first TKI (sunitinib, sorafenib, or pazopanib) for medical reasons; (3) initiation of axitinib or everolimus as a second targeted therapy during February 2012–January 2013. Real-world dosing patterns were summarized. Dose-specific drug costs (as of October 2014) were based on wholesale acquisition costs from RED BOOK Online. PFS was compared between everolimus and axitinib using a multivariable Cox proportion hazards model. Everolimus and axitinib drug costs per month of PFS were compared using multivariable gamma regression models.

Results:

A total of 325 patients received everolimus and 127 patients received axitinib as second targeted therapy. Higher proportions of patients treated with axitinib vs everolimus started on a higher than label-recommended starting dose (14% vs 2%) or experienced dose escalation (11% vs 1%) on second targeted therapy. The PFS did not differ significantly between patients receiving everolimus or axitinib (adjusted hazard ratio (HR)?=?1.16; 95% confidence interval [CI]?=?0.73–1.82). After baseline characteristics adjustment, axitinib was associated with 17% ($1830) higher drug costs per month of PFS compared to everolimus ($12,467 vs $10,637; p?<?0.001).

Limitations:

Retrospective observational study design and only drug acquisition costs considered in drug costs estimates.

Conclusions:

Patients with aRCC receiving axitinib as second targeted therapy were more likely to initiate at a higher than label-recommended dose and were more likely to dose escalate than patients receiving everolimus. With similar observed durations of PFS, drug costs were significantly higher—by 17% per month of PFS—with axitinib than with everolimus.  相似文献   

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Abstract

Objective: To estimate the lifetime economic consequences of glaucoma in France.

Methods: A Markov model estimated the average discounted outcome and cost of glaucoma treatment over a patient's lifetime. Clinical states were defined as first- to fourth-line drugs, no treatment, laser therapy, surgery, blindness and death. After each failure (always after the fourth-line drug) patients could receive either laser treatment or surgery followed by no treatment, or a new treatment. A societal perspective was adopted. Sensitivity analyses were performed.

Results: Discounted medical costs were €7,322 for ocular hypertension treatment (OHT) and €8,488 for a glaucoma patient. Social costs of OHT and glaucoma patients exceeded medical costs. First-line use of the most effective drug would reduce medical and social costs. Societal willingness to pay for the vision benefit would equal the medical costs. Treatment initiated with the most effective drug is a cost saving strategy.

Conclusions: Public health decisions in glaucoma treatment should take a broad economic view embracing the lifetime duration of the disease. There is still a place both within and outside the healthcare system for therapeutic innovations with important economic consequences that bring high added value to patients.  相似文献   

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Aim: To describe treatment pattern, complications, and direct medical costs associated with ankylosing spondylitis (AS) in Chinese urban patients.

Methods: The 2013 China Health Insurance Research Association (CHIRA) urban insurance claims database was used to identify patients with AS. The identified patients were stratified by AS treatments for the comparisons of well established AS-related complications and direct medical costs. Conventional regression analyses adjusted the collected patient baseline characteristics to confirm the impact of treatments on complications and direct medical costs.

Results: Of the identified 1299 patients with AS, 18.0% received non-steroidal anti-inflammatory drugs (NSAID), 11.2% received immunosuppressant, 48.2% received NSAID plus immunosuppressant, 4.6% received biologic agents, and 17.9% received medications without indication for AS. Biologic group was associated with the lowest proportion of AS-related complications (8.3%) that was confirmed by multiple logistic regression analysis (odds ratio = 0.200, p?=?.017). The biologic group was also associated with highest direct medical costs (median: RMB?=?14,539) that were confirmed by the multiple generalized linear model (coefficient = 1.644, p?Conclusions: Biologics were not commonly used for AS in Chinese patients likely due to their high cost. Future studies are needed to confirm the potential long-term clinical benefits associated biologic treatment for AS.  相似文献   

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