To evaluate the costs, consequences, effectiveness, and safety of ciprofloxacin vs standard antibiotic care in patients with an initial acute exacerbation of chronic bronchitis (AECB) as well as recurrent AECBs over a 1-year period.
A total of 240 patients, 18 years or older with chronic bronchitis, with a history of frequent exacerbations (three or more in the past year) presenting with a type 1 or 2 AECB (two or more of increased dyspnea, increased sputum volume, or sputum purulence).
The assessment included AECB symptoms, antibiotics prescribed, concomitant medications, adverse events, hospitalizations, emergency department visits, outpatient resources such as diagnostic tests, procedures, and patient and caregiver out-of-pocket expenses. Patients completed the Nottingham Health Profile, St. George's Respiratory Questionnaire, and the Health Utilities Index. The parameters were recorded with each AECB and at regular quarterly intervals for 1 year. These variables were compared between the ciprofloxacin-treated group and the usual-care-treated group.
Patients receiving ciprofloxacin experienced a median of two AECBs per patient compared to a median of three AECBs per patient receiving usual care. The mean annualized total number of AECB-symptom days was 42.9+/-2.8 in the ciprofloxacin arm compared to 45.6+/-3.0 days in the usual-care arm (p=0.50). The overall duration of the average AECB was 15.2+/-0.6 days for the ciprofloxacin arm compared to 16.3+/-0.6 days for the usual-care arm. Treatment with ciprofloxacin tended to accelerate the resolution of all AECBs compared to usual care (relative risk=1.20; 95% confidence interval [CI], 0.91 to 1.58; p=0.19). Treatment assignment did not affect the interexacerbation period but a history of severe bronchitis, prolonged chronic bronchitis, and an increased number of AECBs in the past year were associated with shorter exacerbations-free periods. There was a slight, but not statistically significant, improvement in all quality of life measures with ciprofloxacin over usual care. The only factors predictive of hospitalization were duration of chronic bronchitis (odds ratio=4.6; 95% CI, 1.6, 13.0) and severity of chronic bronchitis (odds ratio=4.3; 95% CI, 0.8, 24.6). The incremental cost difference of $578 Canadian in favor of usual care was not significant (95% CI, -$778, $1,932). The cost for the ciprofloxacin arm over the usual care arm was $18,588 Canadian per quality-adjusted life year gained. When the simple base case analysis was expanded to examine the effect of risk stratification, the presence of moderate or severe bronchitis and at least four AECBs in the previous year changed the economic and clinical analysis to one favorable to ciprofloxacin with the ciprofloxacin-treated group having a better clinical outcome at lower cost ("win-win" scenario).
Treatment with ciprofloxacin tended to accelerate the resolution of all AECBs compared to usual care; however, the difference was not statistically significant. Further, usual care was found to be more reflective of best available care rather than usual first-line agents such as amoxicillin, tetracycline, or trimethoprim-sulfamethoxazole as originally expected. Despite the similar antimicrobial activities and broad-spectrum coverage of both ciprofloxacin and usual care, the trends in clinical outcomes and all quality of life measurements favor ciprofloxacin. In patients suffering from an AECB with a history of moderate to severe chronic bronchitis and at least four AECBs in the previous year, ciprofloxacin treatment offered substantial clinical and economic benefits. In these patients, ciprofloxacin may be the preferred first antimicrobial choice.
Adjuvant chemotherapy (ACT) may expose patients to morbidity, with little gain in outcome. Treatment with CMF (cyclophosphamide, methotrexate, fluorouracil) has been the standard ACT in several countries for decades. In this model, efficacy, tolerability and quality of life data from the English-language literature were incorporated with Norwegian standard ACT practice and cost data in a cost-effectiveness/cost-utility approach. The CMF efficacy was calculated as 2.45 years saved per patient treated. The quality of life was assumed diminished by 0.33 (0-1 scale) for 6 months and the life years gained were valued Q = 0.86. An 85% dose intensity was employed, one British pound ( 1) was calculated as 12 NOK and a 5% discount rate was used. The total cost of adjuvant CMF, including amounts spent on drugs, administration, travelling and production loss, was calculated to 2365- 6253, depending on the method chosen. Money spent on drugs alone constituted 13-34%. The cost per life year saved was measured as 2170- 5737. A cost-utility approach revealed a cost per quality-adjusted life year (QALY) of 2973- 7860. Adjuvant CMF in breast cancer is cost-effective in Norway.
Metastatic melanoma (MM), a major concern for health-care providers, is increasing. We systematically reviewed published articles describing the impact of interventions (drugs and screening) on quality of life (QoL) in patients with MM, and articles that measured QoL in MM.
We searched secondary databases including MEDLINE, Embase, CINAHL, Cochrane, and DARE from inception to 2006 using MESH terms "melanoma" and "metastases." Economic articles were subject to established quality assessment procedures.
We found 13 QoL and five economic studies (three cost-effectiveness, two cost-utility; average quality = 83% +/- 7%). No strong evidence was found in this review for cost-effectiveness of interferons in Canada (incremental cost-effectiveness ratio [ICER] = $55,090/quality-adjusted life-year) or temozolomide in the United States (ICER = $36,990/Life-year gained based on nonsignificant efficacy differences). Melanoma screening was not cost-effective in the United States ($150,000-931,000/life-saved) or Germany (no survival benefit). From the 13 QoL studies,eight measured baseline QoL; six studied the same population, generating similar results using different approaches/outcomes. Tools used included GLQ-8, QLQ-C30, QLQ-36, QWB-SA, and SF-36. Baseline scores QoL scores ranged from 0.60 to 0.69. Another five studies (N = 959 patients) were randomized trials analyzing QoL in patients treated with dacarbazine alone, dacarbazine +/- interferon, dacarbazine + fotemustine, interleukin +/- histamine, and temozolomide. Little difference was found in QoL scores between drugs or between baseline and end point.
Cost-effectiveness has not been widely demonstrated for treatment of MM. Only two studies with unimpressive results exist for treatments. Screening was not cost-effective in the United States or Germany. Generally, no significant improvements in QoL were found for any alternative for treating MM. A need exists for effective treatments that improve duration and QoL.
Monthly dosing with ranibizumab (RBZ) is needed to achieve maximal visual gains in patients with neovascular ('wet') age-related macular degeneration (wAMD). In Sweden, dosing is performed as needed (RBZ PRN), resulting in suboptimal efficacy. Intravitreal aflibercept (IVT-AFL) every 2 months after three initial monthly doses was clinically equivalent to RBZ monthly dosing (RBZ q4) in wAMD clinical trials. We assessed the cost-effectiveness of IVT-AFL versus RBZ q4 and RBZ PRN in Sweden.
A Markov model compared IVT-AFL to RBZ q4 or RBZ PRN over 2 years. Health states were based on visual acuity in better-seeing eye; a proportion discontinued treatment monthly or upon visual acuity
We aimed to assess alcohol consumption and alcohol-attributed disease burden by DALYs (disability adjusted life years) in the BRICS countries (Brazil, Russia, India, China and South Africa) between 1990 and 2013, and explore to what extent these countries have implemented evidence-based alcohol policies during the same time period.
A comparative risk assessment approach and literature review, within a setting of the BRICS countries. Participants were the total populations (males and females combined) of each country. Levels of alcohol consumption, age-standardized alcohol-attributable DALYs per 100?000 and alcohol policy documents were measured.
The alcohol-attributed disease burden mirrors level of consumption in Brazil, Russia and India, to some extent in China, but not in South Africa. Between the years 1990-2013 DALYs per 100 000 decreased in Brazil (from 2124 to 1902), China (from 1719 to 1250) and South Africa (from 2926 to 2662). An increase was observed in Russia (from 4015 to 4719) and India (from 1574 to 1722). Policies were implemented in all of the BRICS countries and the most common were tax increases, drink-driving measures and restrictions on advertisement.
There was an overall decrease in alcohol-related DALYs in Brazil, China and South Africa, while an overall increase was observed in Russia and India. Most notably is the change in DALYs in Russia, where a distinct increase from 1990-2005 was followed by a steady decrease from 2005-2013. Even if assessment of causality cannot be done, policy changes were generally followed by changes in alcohol-attributed disease burden. This highlights the importance of more detailed research on this topic.
Cites: Lancet. 2015 Nov 28;386(10009):2145-91 PMID 26321261
Various attempts have been made to measure the burden of alcohol, drugs and tobacco smoking on population health, and mortality is an often used measure. As part of the governmental strategy to prevent use of alcohol, drugs, doping and tobacco (ANDT) in Sweden, we assessed disease burden measured by DALY (Disability Adjusted Life Years), attributed to alcohol, drugs and tobacco over time, as an overall indicator of problem level. DALY was developed within the Global Burden of Disease study (GBD), and combines life lost to premature death (YLL) and years lived with disability (YLD) in one measure. In 2010 tobacco contributed to 7.7% of the total disease burden in Sweden, followed by alcohol (3.4%) and drugs (1.3%). The disease burden caused by tobacco has decreased substantially since 1990, while small changes are observed for alcohol and drugs. Much of the disease burden specially related to drugs and alcohol was related to YLD, which can be captured with the DALY measure.
Controversy persists about the most efficient allocation of healthcare funds for cardiovascular disease prevention. Previous economic analyses have generally focused on primary or secondary prevention as discrete categories.
To address the information required by decision-makers to distribute budgets optimally across an entire population at risk in view of recommendations promulgated by the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III).
The Continuum of Risk Evaluation (CORE) model is an individual patient simulation of the occurrence of cardiovascular disease allowing for analyses over a broad range of risk. All events are tallied, costs are applied, and survival is modified accordingly. Disaggregated presentation of the results allows decision-makers to evaluate the budgetary implications and cost effectiveness of different strategies according to the risk at which treatment is initiated. This process is illustrated for the United States using information from the 1988-1994 National Health and Nutrition Examination Survey and pravastatin trials.
Secondary prevention with pravastatin costs dollar 2900 per life-year gained for men and dollar 1100 per life-year gained for women. Lowering the treatment threshold to incorporate primary prevention yields cost-effectiveness ratios that remain below dollar 25 000 per undiscounted life-year gained until a 10-year cardiovascular disease risk of 14.4%. Cost savings are possible for very high-risk patients.
The economic impact of an integrated approach to prevention of cardiovascular disease has not been thoroughly explored. CORE permits realistic analysis of policy decisions involving the entire continuum of risk rather than isolated consideration of specific disease stages, and thus provides a unique tool for assessing the full implications of treatment guidelines such as those of the NCEP ATP III.
OBJECTIVE: To assess the cost effectiveness of screening men aged 65 for abdominal aortic aneurysm. DESIGN: Cost effectiveness analysis based on a probabilistic, enhanced economic decision analytical model from screening to death. POPULATION AND SETTING: Hypothetical population of men aged 65 invited (or not invited) for ultrasound screening in the Danish healthcare system. DATA SOURCES: Published results from randomised trials and observational epidemiological studies retrieved from electronic bibliographic databases, and supplementary data obtained from the Danish Vascular Registry. DATA SYNTHESIS: A hybrid decision tree and Markov model was developed to simulate the short term and long term effects of screening for abdominal aortic aneurysm compared with no systematic screening on clinical and cost effectiveness outcomes. Probabilistic sensitivity analyses using Monte Carlo simulation were carried out. Results were presented in a cost effectiveness acceptability curve, an expected value of perfect information curve, and a curve showing the expected (net) number of avoided deaths from abdominal aortic aneurysm over time after the introduction of screening. The model was validated by calibrating base case health outcomes and expected activity levels against evidence from the recent Cochrane review of screening for abdominal aortic aneurysm. RESULTS: The estimated costs per quality adjusted life year (QALY) gained discounted at 3% per year over a lifetime for costs and QALYs was pound43 485 (euro54,852; $71,160). At a willingness to pay threshold of pound30,000 the probability of screening for abdominal aortic aneurysm being cost effective was less than 30%. One way sensitivity analyses showed the incremental cost effectiveness ratio varying from pound32,640 to pound66,001 per QALY. CONCLUSION: Screening for abdominal aortic aneurysm does not seem to be cost effective. Further research is needed on long term quality of life outcomes and costs.
To conduct an economic analysis comparing tamoxifen and anastrozole (Arimidex) in the adjuvant treatment of hormone receptor-positive (HR+), post-menopausal early breast cancer patients.
An economic model examined typical patients (64 years of age, HR+, 64% node negative) from the Arimidex, tamoxifen alone, or in combination (ATAC) trial over a lifetime horizon. Rates of events were derived from ATAC trial results. Post-trial event rates were drawn from the literature for tamoxifen; event rates for anastrozole were modified by the relative risks observed in the ATAC trial. Resource utilization was drawn from Statistics Canada's Population Health Model for breast cancer, supplemented by an expert panel. A public health care system perspective, 2004 Canadian prices and a 5% discount rate were employed.
Anastrozole-taking patients incurred additional hormonal treatment costs compared to tamoxifen-taking patients (incremental lifetime cost, 6,974 Canadian dollars per patient), partially offset by reduced downstream recurrences of breast cancer (1,143 Canadian dollars lifetime savings per patient) for a net incremental cost of 5,796 Canadian dollars per patient on anastrozole. The anastrozole-treated patients were projected to experience a 5.6% absolute risk reduction of first breast cancer recurrence and a 2.8% absolute risk reduction in breast cancer death. This corresponded to 30,000 Canadian dollars per life year gained and 28,000 Canadian dollars per quality-adjusted life year gained (95% confidence interval, 17,428 to 54,605 Canadian dollars). The results were affected by the duration and extent of anastrozole benefit under sensitivity analysis but remained cost-effective.
Compared to tamoxifen, anastrozole therapy is effective and cost-effective as initial adjuvant therapy in post-menopausal, HR+ early breast cancer patients.
There are few reports examining the effect of surgical delay on outcomes following operative treatment of lower extremity fractures. Delays in the surgery for closed tibial shaft fractures have been reported to increase the overall complication rate, postoperative hospital stays and crude costs to the health care system. Our purpose was to estimate the cost-effectiveness and cost-utility associated with the adoption of a programme of early operative treatment of all closed tibial shaft fractures. We performed cost analyses based upon data obtained from an observational study. A cohort of patients with closed tibial shaft fractures was identified at a university-affiliated level I trauma centre. Patients were divided into an early surgical group (within 12 h) and delayed surgical group (longer than 12 h). Study outcomes included time to fracture union (weeks), direct inpatient and outpatient costs associated with each intervention, loss of productivity costs, and utilities (patient health perception) as determined from content experts. Sixteen patients were operated on within 12 h of injury and 19 patients were treated later than 12 h after their fracture. These groups were similar for all baseline variables. The average time to fracture union was 28.2 weeks (SD 9.4) and 44.2 weeks (SD 7.4) for the early surgical group and the delayed surgical group, respectively ( p