Time to death of hospitalized injured patients as a measure of quality of care

BACKGROUND: In population-based studies, the quality of care delivered to injured patients is commonly judged by hospital survival rates. Evidence suggests injured patients surviving hospitalization remain at risk for death from their injuries after discharge. Patient characteristics associated with higher risk of late death are not completely defined. METHODS: The National Death Index is a government-maintained database composed of death certificate records from all decedents in the United States. Patients in a trauma registry were cross-linked to decedents in National Death Index on the basis of Social Security number or other unique identifiers. Decedents' time from injury to death was calculated. Logistic regression models were fit to those who died at hospital discharge and those who died in the first year after injury. RESULTS: Among 4293 hospitalized injured patients recorded in a trauma registry, 157 died during hospitalization. Among the 4136 discharged alive, 91 patients were linked to death certificate records filed in the 365 days after discharge. Patients over the age of 65 had a 15-fold greater odds of death than younger patients. CONCLUSION: Trauma registry data cross-linked to vital statistics records is practicable. Patients who die in the year after injury differ from the traditional population used to evaluate quality of trauma care, and new standards are needed that evaluate long-term survival.     

Behavioral changes associated with deep brain stimulation surgery for Parkinson’s disease

Evaluation for psychiatric and cognitive dysfunction is a crucial part of preoperative assessment for deep brain stimulation (DBS) surgery. All candidates for DBS should be treated for active psychiatric disorders, and the treatment team should also screen for past psychiatric history, which may predispose to postoperative psychiatric illness. A wide range of behavioral symptoms have been seen following DBS, including depression, hallucinations or true psychosis, mania, and impulsivity. Suicidal ideation should be treated aggressively. Cognitive changes may occur, but data are currently too limited to make predictions regarding subtle effects on cognition. However, patients with dementia may experience further decline in cognitive function following DBS.     

A placebo-controlled pharmacodynamic and pharmacokinetic interaction study between tamsulosin and acenocoumarol

AIM: To evaluate pharmacokinetic and pharmacodynamic interactions between tamsulosin and acenocoumarol. METHODS: Twelve healthy volunteers received tamsulosin 0.4 mg or placebo once daily for 9 days in a double-blind, cross-over study. On day 5 of each study period, a single 10-mg oral dose of racemic acenocoumarol was administered. RESULTS: The ratios (point estimates (90% confidence intervals)) of values in the presence and absence of tamsulosin were: AUCPT 1.01 (0.98, 1.03); maximum prothrombin time (Ptmax) 0.99 (0.94, 1.05); AUC (R)-acenocoumarol 1.02 (0.90, 1.16), and AUC (S)-acenocoumarol 1.03 (0.89, 1.20). Both combinations, tamsulosin and placebo with acenocoumarol, were well-tolerated. CONCLUSIONS: Multiple doses of tamsulosin had no effect on the pharmacokinetics or pharmacodynamics of a single high dose of acenocoumarol.     

Long-term benefits in self-reported health status of nasal continuous positive airway pressure therapy for obstructive sleep apnoea

Doubt has been expressed about the efficacy of nasal continuous positive airways pressure (NCPAP) therapy for sleep apnoea. Recent evidence from a randomized controlled trial of 1 month duration, suggested that NCPAP therapy can have a substantial impact on subjective and clinical outcomes in the short term, but data was not available to determine whether these effects were sustained over the long term. This study, an extension of the original trial, examined whether the beneficial impacts of NCPAP continued over the longer term. Patients were followed-up 1 month after being placed on active or sub-therapeutic NCPAP. They completed health status measures and a clinical test of sleepiness. After this period, all patients were placed on NCPAP and followed up 5 months later. The beneficial impact of NCPAP on sleep apnoea was sustained on all measures at follow-up. Furthermore, those who had initially been in the sub-therapeutic arm gained scores after 5 months of NCPAP similar to those of the active group. The impact of NCPAP appears sustained in the longer term. Subjective health status instruments have been advocated as important outcome points in randomized trials. This study would support such a use, and shows the important role of patient report in the evaluation of health care.     

Cervical cancer outcomes analysis: impact of age, race, and comorbid illness on hospitalizations for invasive carcinoma of the cervix

OBJECTIVE: The aim of this study was to evaluate the association of age, race, and comorbid illness with procedures and complications in hospitalized patients with invasive carcinoma of the cervix in a statewide population-based database over a 3-year period. METHODS: Hospitalizations were classified into homogeneous subgroups based on a diagnosis of invasive cervical cancer. Cancer-related complications and comorbid diseases were evaluated. chi(2) and t tests determined differences in means or proportions. Linear regression techniques were applied to build models for hospitalization charges and lengths of stay (LOS). RESULTS: There were 1009 admissions. The mean age was 49.5, with a median age of 46 (21-100, SD 15.4). Of the total, 606/1009 (60%) were white, 354/1009 (35%) were African-American (AA), and 5% were "other" races. AAs were more likely to have Medicaid or be uninsured (44% vs 23%, P = 0. 001) and were more likely to be admitted for an emergency (unadjusted odds ratio (OR) = 1.6; 1.2-2.2), to have a comorbid illness (P = 0.001), to be admitted for a cancer-related complication (P = 0.036), to be admitted for a transfusion (P = 0. 01), and to be admitted for radiation therapy rather than surgery (P = 0.001). The following were associated with LOS and higher hospital costs: emergency admissions for complications of cancer, comorbid illness, and older age. CONCLUSIONS: Racial differences exist in patterns of admission, type of therapy, and severity of illness; however, there were no differences in charges or LOS for similar procedures. The large percentage of African-Americans uninsured or insured by government-supported programs indicates the potential impact of public policy on the care of these patients. Socioeconomic status rather than phenotypic appearance may be a more important determinant of outcome.     

Principles of Good Practice for Budget Impact Analysis: Report of the ISPOR Task Force on Good Research Practices—Budget Impact Analysis

OBJECTIVES: There is growing recognition that a comprehensive economic assessment of a new health-care intervention at the time of launch requires both a cost-effectiveness analysis (CEA) and a budget impact analysis (BIA). National regulatory agencies such as the National Institute for Health and Clinical Excellence in England and Wales and the Pharmaceutical Benefits Advisory Committee in Australia, as well as managed care organizations in the United States, now require that companies submit estimates of both the cost-effectiveness and the likely impact of the new health-care interventions on national, regional, or local health plan budgets. Although standard methods for performing and presenting the results of CEAs are well accepted, the same progress has not been made for BIAs. The objective of this report is to present guidance on methodologies for those undertaking such analyses or for those reviewing the results of such analyses. METHODS: The Task Force was appointed with the advice and consent of the Board of Directors of ISPOR. Members were experienced developers or users of budget impact models, worked in academia, industry, and as advisors to governments, and came from several countries in North America, Oceana, Asia, and Europe. The Task Force met to develop core assumptions and an outline before preparing a draft report. They solicited comments on the outline and two drafts from a core group of external reviewers and more broadly from the membership of ISPOR at two ISPOR meetings and via the ISPOR web site. RESULTS: The Task Force recommends that the budget impact of a new health technology should consider the perspective of the specific health-care decision-maker. As such, the BIA should be performed using data that reflect, for a specific health condition, the size and characteristics of the population, the current and new treatment mix, the efficacy and safety of the new and current treatments, and the resource use and costs for the treatments and symptoms as would apply to the population of interest. The Task Force recommends that budget impact analyses be generated as a series of scenario analyses in the same manner that sensitivity analyses would be provided for CEAs. In particular, the input values for the calculation and the specific cost outcomes presented (a scenario) should be specific to a particular decision-maker's population and information needs. Sensitivity analysis should also be in the form of alternative scenarios chosen from the perspective of the decision-maker. The primary data sources for estimating the budget impact should be published clinical trial estimates and comparator studies for efficacy and safety of current and new technologies as well as, where possible, the decision-maker's own population for the other parameter estimates. Suggested default data sources also are recommended. These include the use of published data, well-recognized local or national statistical information and in special circumstances, expert opinion. Finally, the Task Force recommends that the analyst use the simplest design that will generate credible and transparent estimates. If a health condition model is needed for the BIA, it should reflect health outcomes and their related costs in the total affected population for each year after the new intervention is introduced into clinical practice. The model should be consistent with that used for the CEA with regard to clinical and economic assumptions. CONCLUSIONS: The BIA is important, along with the CEA, as part of a comprehensive economic evaluation of a new health technology. We propose a framework for creating budget impact models, guidance about the acquisition and use of data to make budget projections and a common reporting format that will promote standardization and transparency. Adherence to these proposed good research practice principles would not necessarily supersede jurisdiction-specific budget impact guidelines, but may support and enhance local recommendations or serve as a starting point for payers wishing to promulgate methodology guidelines.     

Aseptic meningitis epidemic during a West Nile virus avian epizootic

While enteroviruses have been the most commonly identified cause of aseptic meningitis in the United States, the role of the emerging, neurotropic West Nile virus (WNV) is not clear. In summer 2001, an aseptic meningitis epidemic occurring in an area of a WNV epizootic in Baltimore, Maryland, was investigated to determine the relative contributions of WNV and enteroviruses. A total of 113 aseptic meningitis cases with onsets from June 1 to September 30, 2001, were identified at six hospitals. WNV immunoglobulin M tests were negative for 69 patients with available specimens; however, 43 (61%) of 70 patients tested enterovirus-positive by viral culture or polymerase chain reaction. Most (76%) of the serotyped enteroviruses were echoviruses 13 and 18. Enteroviruses, including previously rarely detected echoviruses, likely caused most aseptic meningitis cases in this epidemic. No WNV meningitis cases were identified. Even in areas of WNV epizootics, enteroviruses continue to be important causative agents of aseptic meningitis.     

Papillary lesions of the breast: To excise or observe?

Papillary lesions of the breast range from benign to atypical to malignant. Although papillomas without frank cancer are benign, their management remains controversial. When a core needle biopsy of a lesion yields a diagnosis of intraductal papilloma with atypia, excision is generally recommended to rule out a concurrent malignant neoplasm. For intraductal papillomas without atypia, however, recommendations for excision versus observation are variable. The aims of this study are to evaluate the rate of concurrent malignancies for intraductal papilloma diagnosed on core needle biopsy and to assess the long‐term risk of developing cancer after the diagnosis of a papillary lesion. This single institution retrospective study analyzed 259 patients that were diagnosed with intraductal papilloma (IDP) by core needle biopsy from 1995 to 2010. Patients were grouped by initial diagnosis into three groups (papilloma without atypia, papilloma with atypia, and papilloma with atypical duct hyperplasia or atypical lobular hyperplasia (ADH/ALH) and followed up for long‐term outcomes. After a core needle biopsy showing IDP with atypia or IDP + ADH/ALH, surgical excision yielded a diagnosis of concomitant invasive or ductal in situ cancer in greater that 30% of cases. For intraductal papilloma without atypia, the likelihood of cancer was much lower. Moreover, even with excision, the finding of intraductal papilloma with atypia carries a significant risk of developing cancer long‐term, and such patients should be followed carefully and perhaps should be considered for chemoprevention.