J. Michael Swint

Neurocognition in patients with brain metastases treated with radiosurgery or radiosurgery plus whole-brain irradiation: a randomised controlled trial

BACKGROUND It is unclear whether the benefit of adding whole-brain radiation therapy (WBRT) to stereotactic radiosurgery (SRS) for the control of brain-tumours outweighs the potential neurocognitive risks. We proposed that the learning and memory functions of patients who undergo SRS plus WBRT are worse than those of patients who undergo SRS alone. We did a randomised controlled trial to test our prediction. METHODS Patients with one to three newly diagnosed brain metastases were randomly assigned using a standard permutated block algorithm with random block sizes to SRS plus WBRT or SRS alone from Jan 2, 2001, to Sept 14, 2007. Patients were stratified by recursive partitioning analysis class, number of brain metastases, and radioresistant histology. The randomisation sequence was masked until assignation, at which point both clinicians and patients were made aware of the treatment allocation. The primary endpoint was neurocognitive function: objectively measured as a significant deterioration (5-point drop compared with baseline) in Hopkins Verbal Learning Test-Revised (HVLT-R) total recall at 4 months. An independent data monitoring committee monitored the trial using Bayesian statistical methods. Analysis was by intention-to-treat. This trial is registered at www.ClinicalTrials.gov, number NCT00548756. FINDINGS After 58 patients were recruited (n=30 in the SRS alone group, n=28 in the SRS plus WBRT group), the trial was stopped by the data monitoring committee according to early stopping rules on the basis that there was a high probability (96%) that patients randomly assigned to receive SRS plus WBRT were significantly more likely to show a decline in learning and memory function (mean posterior probability of decline 52%) at 4 months than patients assigned to receive SRS alone (mean posterior probability of decline 24%). At 4 months there were four deaths (13%) in the group that received SRS alone, and eight deaths (29%) in the group that received SRS plus WBRT. 73% of patients in the SRS plus WBRT group were free from CNS recurrence at 1 year, compared with 27% of patients who received SRS alone (p=0.0003). In the SRS plus WBRT group, one case of grade 3 toxicity (seizures, motor neuropathy, depressed level of consciousness) was attributed to radiation treatment. In the group that received SRS, one case of grade 3 toxicity (aphasia) was attributed to radiation treatment. Two cases of grade 4 toxicity in the group that received SRS alone were diagnosed as radiation necrosis. INTERPRETATION Patients treated with SRS plus WBRT were at a greater risk of a significant decline in learning and memory function by 4 months compared with the group that received SRS alone. Initial treatment with a combination of SRS and close clinical monitoring is recommended as the preferred treatment strategy to better preserve learning and memory in patients with newly diagnosed brain metastases.

Community-based participatory research to prevent substance abuse and HIV/AIDS in African-American adolescents

Adolescence is a time for exploration and risk-taking; in todays urban environment, with the twin threats of substance abuse and HIV/AIDS, the stakes are particularly high. This paper describes a community-based participatory research project to design, implement, and evaluate a faith-based substance abuse and HIV/AIDS prevention program for African-American adolescents. A coalition of university-based investigators and African-American church member stakeholders collaborated on all aspects of Project BRIDGE, the 3-year intervention to reduce substance abuse and HIV/AIDS in African-American adolescents. Our results support the use of community-based participatory research to create desirable change in this setting. Adolescents who participated in Project BRIDGE reported significantly less marijuana and other drug use and more fear of AIDS than a comparison group. Project BRIDGE has been designated an official ministry of the church and the program has been extended to others in the larger metropolitan community. The church now has a well-trained volunteer staff. University faculty developed skills in negotiating with community-based settings. The coalition remains strong with plans for continued collaborative activities.

Hemoglobin A1c improvements and better diabetes-specific quality of life among participants completing diabetes self-management programs: A nested cohort study

BackgroundNumerous primary care innovations emphasize patient-centered processes of care. Within the context of these innovations, greater understanding is needed of the relationship between improvements in clinical endpoints and patient-centered outcomes. To address this gap, we evaluated the association between glycosylated hemoglobin (HbA1c) and diabetes-specific quality of life among patients completing diabetes self-management programs.MethodsWe conducted a retrospective cohort study nested within a randomized comparative effectiveness trial of diabetes self-management interventions in 75 diabetic patients. Multiple linear regression models were developed to examine the relationship between change in HbA1c from baseline to one-year follow-up and Diabetes-39 (a diabetes-specific quality of life measure) at one year.ResultsHbA1c levels improved for the overall cohort from baseline to one-year follow-up (t (74) = 3.09, p = .0029). One-year follow up HbA1c was correlated with worse overall quality of life (r = 0.33, p = 0.004). Improvements in HbA1c from baseline to one-year follow-up were associated with greater D-39 diabetes control (β = 0.23, p = .04) and D-39 sexual functioning (β = 0.25, p = .03) quality of life subscales.ConclusionsImprovements in HbA1c among participants completing a diabetes self-management program were associated with better diabetes-specific quality of life. Innovations in primary care that engage patients in self-management and improve clinical biomarkers, such as HbA1c, may also be associated with better quality of life, a key outcome from the patient perspective.

Cost-effectiveness Analysis of Herpes Simplex Virus Testing and Treatment Strategies in Febrile Neonates

OBJECTIVE To determine the clinical effectiveness and cost-effectiveness of testing for and empirically treating herpes simplex virus (HSV) infection in neonates with fever aged from birth to 28 days. DESIGN Cost-effectiveness analysis. SETTING Decision model. PATIENTS Neonates with fever with no other symptoms and neonates with fever with cerebrospinal fluid (CSF) pleocytosis. INTERVENTIONS Four clinical strategies: (1) HSV testing and empirical treatment while awaiting test results; (2) HSV testing and treatment if test results were positive for HSV or the patient had symptoms of HSV; (3) treatment alone without testing; or (4) no HSV testing or treatment unless the patient exhibited symptoms. The 2 HSV testing methods used were CSF HSV polymerase chain reaction (PCR) and comprehensive evaluation with blood HSV PCR, CSF HSV PCR, and multiple viral cultures. MAIN OUTCOME MEASURES Twelve-month survival and quality-adjusted life expectancy with a cost-effectiveness threshold of

Screening for Patients with Alcohol Problems: Severity of Patients Identified by the Cage

100,000 per quality-adjusted life year (QALY) gained. RESULTS Clinical strategy 1, when applied in febrile neonates with CSF pleocytosis, saved 17 lives per 10,000 neonates and was cost-effective using CSF HSV PCR testing (

Economic evaluation of pediatric cancer treatment: a systematic literature review.

55,652/QALY gained). The cost-effectiveness of applying clinical strategy 1 in all febrile neonates depended on the cost of the CSF HSV PCR, prevalence of disease, and parental preferences for neurodevelopmental outcomes. Clinical strategies using comprehensive HSV testing were not cost-effective in febrile neonates (

A Multivariate Analysis of the Likelihood and Volume of Preventive Visit Demand in a Prepaid Group Practice

368,411/QALY gained) or febrile neonates with CSF pleocytosis (

Cost minimization analysis of two treatment regimens for low-risk rhabdomyosarcoma in children: a report from the Children's Oncology Group.

110,190/QALY gained). CONCLUSIONS Testing with CSF HSV PCR and empirically treating with acyclovir sodium saves lives and is cost-effective in febrile neonates with CSF pleocytosis. It is not a cost-effective use of health care resources in all febrile neonates.

The cost of screening adolescents for overweight and hypertension using a community partnership model.

Primary care physicians are well situated to identify patients with substance abuse problems and motivate them to seek appropriate assistance, but active programs are the exception. A study in a community setting was undertaken to assess the CAGE (the first letters of key words in a series of four questions about drinking: cut down; annoyed; guilty; and eye-opener), instrument in the routine screening for alcohol problems in both new and established patients. The screening process identified subjects for a pilot evaluation of a motivational interview designed to encourage problem-solving behavior. This article focuses on the screening results and the use of the CAGE instrument. During June and July of 1990, 687 patients of two primary care physicians belonging to a large group practice were asked to complete a health questionnaire that included the CAGE. Those who responded affirmatively to at least two of the four CAGE questions were requested to participate in follow-up assessment of problems associated with alcohol and health. The type and severity of alcohol problems experienced by patients who scored positive on the CAGE are described. Prevalence of a positive score on the CAGE was 8.6 percent with males, smokers, and blue collar and unemployed persons being more likely to score positive. The positive predictive value was .68. Primarily, persons with moderate alcohol problems were identified. Results show that the CAGE instrument is a useful screening device for identifying those with mild to moderate substance abuse problems, increasing the opportunity for intervention prior to serious medical complications. The instrument is easily administered, and has demonstrated relatively high levels of sensitivity and specificity. When combined with assessment and motivational interviews, the CAGE shows promise in the secondary prevention of substance abuse and related health problems.

An economic analysis of public sector collective bargaining and strike activity

OBJECTIVE: Although there is a growing national focus on health care cost containment and accountability in resource utilization, childhood cancer therapy costs continue to increase without proportionate survival improvements. Economic evaluations (EEs) such as cost and/or cost effectiveness analysis may identify areas to improve resource efficiency. This review aims to identify and characterize the EE studies performed in this field. METHODS: We performed a structured literature search of the Medline, PubMed, and the National Health Service EE databases from 2000 to 2011. Concepts for the search included “cost analyses,” “child,” and “cancer.” Studies were limited to original research, comparison of 2 or more treatments using monetary units, English language, and originating from economically developed countries. Identified studies were assessed by the Drummond checklist and characterized by the therapy studied, data sources, and research perspectives. RESULTS: Forty studies met inclusion criteria. Eleven studied chemotherapy, surgery, or radiation. Twenty-nine studied supportive measures such as growth factor support or treatment of infection. The median Drummond score was 6 of 10 (range, 2–9). Only 15 (36%) included treatment outcomes when comparing costs. Methodological limitations were common. CONCLUSIONS: A wide variety of topics and methodological limitations made comparisons between studies difficult. Strategies for increasing the generalizability of future EE studies are presented. Substantial opportunity exists for EE research in childhood cancer.