This vaccine was efficacious in preventing rotavirus gastroenteritis, decreasing severe disease and health care contacts. The risk of intussusception was similar in vaccine and placebo recipients. (ClinicalTrials.gov number, NCT00090233.)
Evidence-based health-care decision making requires comparisons of all relevant competing interventions. In the absence of randomized, controlled trials involving a direct comparison of all treatments of interest, indirect treatment comparisons and network meta-analysis provide useful evidence for judiciously selecting the best choice(s) of treatment. Mixed treatment comparisons, a special case of network meta-analysis, combine direct and indirect evidence for particular pairwise comparisons, thereby synthesizing a greater share of the available evidence than a traditional meta-analysis. This report from the ISPOR Indirect Treatment Comparisons Good Research Practices Task Force provides guidance on the interpretation of indirect treatment comparisons and network meta-analysis to assist policymakers and health-care professionals in using its findings for decision making. We start with an overview of how networks of randomized, controlled trials allow multiple treatment comparisons of competing interventions. Next, an introduction to the synthesis of the available evidence with a focus on terminology, assumptions, validity, and statistical methods is provided, followed by advice on critically reviewing and interpreting an indirect treatment comparison or network meta-analysis to inform decision making. We finish with a discussion of what to do if there are no direct or indirect treatment comparisons of randomized, controlled trials possible and a health-care decision still needs to be made.
Evidence-based health care decision making requires comparison of all relevant competing interventions. In the absence of randomized controlled trials involving a direct comparison of all treatments of interest, indirect treatment comparisons and network meta-analysis provide useful evidence for judiciously selecting the best treatment(s). Mixed treatment comparisons, a special case of network meta-analysis, combine direct evidence and indirect evidence for particular pairwise comparisons, thereby synthesizing a greater share of the available evidence than traditional meta-analysis. This report from the International Society for Pharmacoeconomics and Outcomes Research Indirect Treatment Comparisons Good Research Practices Task Force provides guidance on technical aspects of conducting network meta-analyses (our use of this term includes most methods that involve meta-analysis in the context of a network of evidence). We start with a discussion of strategies for developing networks of evidence. Next we briefly review assumptions of network meta-analysis. Then we focus on the statistical analysis of the data: objectives, models (fixed-effects and random-effects), frequentist versus Bayesian approaches, and model validation. A checklist highlights key components of network meta-analysis, and substantial examples illustrate indirect treatment comparisons (both frequentist and Bayesian approaches) and network meta-analysis. A further section discusses eight key areas for future research.
The medical RU and cost data were obtained from the MarketScan Research Database for the years 1998-2003. This database contains inpatient, outpatient and prescription drug data for approximately 14 million individuals of all ages, covered under a variety of fee-for-service and capitated provider reimbursement arrangements, including those with Medicare and private insurance. The work loss estimates were based on the MarketScan Health and Productivity Management Database. Claims for services incurred between 1 January 1998 and 31 December 2003 were screened to identify a cohort of HZ patients based on the presence of at least one International Classification of Diseases, 9th Revision (ICD-9) diagnosis code 053.xx. Each patient was assigned an index date based on the earliest observed occurrence of an HZ diagnosis. A cohort of PHN patients was identified as a subset of the HZ cohort with ICD-9 codes 053.12, 053.13, 053.19 or 729.2x in the period of 90 days to 12 months after the index date. Multivariable regression was used to compare HZ cases with matched controls after adjusting for demographic characteristics, insurance status, co-morbidities and medical expenditure in the 6 months prior to diagnosis for each of the endpoints. Separate regression models were developed, in which age and immune status were stratified. All costs were adjusted to March 2008 values using the medical care component of the Consumer Price Index. The average per patient cost of all HZ cases was $US605 in the first 90 days after diagnosis and $US1052 at 1 year. For the subset with PHN, the average per patient cost of HZ at 1 year was $US3815. For the subset with an immunocompromising condition, the average HZ cost at 1 year was $US1745. The majority of the costs were the result of outpatient visits and prescription drugs. The subset of HZ cases that had both absence hour and short-term disability (STD) records available had 26.5 absence hours and 2.9 STD days. Healthcare utilization, medical care costs and work loss all increased with age for all HZ cases. Based on the results from the present study, the direct medical cost burden of HZ in the US is high, exceeding $US1000 per HZ patient. This direct medical cost may be nearly twice as high in immunocompromised patients and four times as high in the subset of HZ cases with PHN. The direct medical cost burden of HZ may exceed $US1 billion annually in the US. The majority of medical RU and cost burden is incurred by the elderly. Although many people with HZ may no longer be in the workforce, HZ does contribute to lost work time.
OBJECTIVE:To conduct a population-based study to assess health care utilization (HCU) and costs associated with herpes zoster (HZ) and its complications, including postherpetic neuralgia (PHN) and nonpain complications, in adults aged 22 years and older. PATIENTS AND METHODS:Medical record data on HCU were abstracted for all confirmed new cases of HZ from January 1, 1996, through December 31, 2001, among residents of Olmsted County, Minnesota. Herpes zoster-related costs were estimated by applying the Medicare Payment Fee Schedule to health care encounters and mean wholesale prices to medications. All costs were adjusted to 2006 US dollars using the medical care component of the Consumer Price Index. RESULTS:The HCU and cost of the 1669 incident HZ cases varied, depending on the complications involved. From 3 weeks before to 1 year after initial diagnosis, there were a mean of 1.8 outpatient visits and 3.1 prescribed medications at a cost of $720 for cases without PHN or nonpain complications compared with 7.5 outpatient visits and 14.7 prescribed medications at a cost of $3998 when complications, PHN, or nonpain complications were present. CONCLUSION:The annual medical care cost of treating incident HZ cases in the United States, extrapolated from the results of this study in Olmsted County, is estimated at $1.1 billion. Most of the costs are for the care of immunocompetent adults with HZ, especially among those 50 years and older. © 2009 Mayo Foundation for Medical Education and ResearchN early 1 million new cases of herpes zoster (HZ) occur annually in the United States. 1,2 Herpes zoster results from reactivation of the varicella-zoster virus, which remains dormant after infection with chickenpox. Declining cellular immunity associated with aging and immunocompromising conditions increase the risk of HZ and HZ complications.  However, most HZ cases (>90%) occur in immunocompetent people. 1,2 Herpes zoster can adversely affect a person's health-related quality of life 6-8 because of complications such as eye and other nonpain complications 2 as well as acute and chronic pain (postherpetic neuralgia [PHN]) that can result in severe activity limitations and sleep disturbances. 2,6,9 Claims data have been used to estimate the health care utilization (HCU) and cost of HZ in the United States. 10,11 However, such data have potential limitations. Claims data may not capture all the HCU and costs attributable to the complications of HZ, including PHN and nonpain complications. In the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM), 12 few HZ complication-specific diagnostic codes are available, and they may not be used reliably. Although there is an ICD-9-CM diagnostic code for PHN, there is no standard definition for PHN that is used by all physicians. In addition, not all HZ-related visits are coded with a zosterspecific diagnostic code, especially visits that occur before definitive diagnosis. Medications, laboratory tests, and procedures are not directly linke...
In this post hoc analysis of healthy premature infants, the pentavalent rotavirus vaccine was generally well-tolerated and substantially reduced rotavirus-attributable hospitalizations and emergency department visits compared with placebo. Overall, vaccine safety and efficacy seemed to be generally comparable to the results in the REST study population as a whole. These results support vaccinating healthy premature infants on the same schedule as term infants.
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