Prophylactic mastectomy and oophorectomy for women at risk of breast and ovarian cancer: Incorporating preferences in a decision analysis

The discoveries of the BRCA1 and BRCA2 genes have made it possible for women of families with hereditary breast/ovarian cancer to determine if they carry cancer-predisposing genetic mutations. Women with germline mutations have significantly higher probabilities of developing both cancers than the general population. Since the presence of a BRCA1 or BRCA2 mutation does not guarantee future cancer development, the appropriate course of action remains uncertain for these women. Prophylactic mastectomy and oophorectomy remain controversial since the underlying premise for surgical intervention is based more upon reduction in the estimated risk of cancer than on actual evidence of clinical benefit. Issues that are incorporated in a woman's decision making process include quality of life without breasts, ovaries, attitudes toward possible surgical morbidity as well as a remaining risk of future development of breast/ovarian cancer despite prophylactic surgery. The incorporation of patient preferences into decision analysis models can determine the quality-adjusted survival of different prophylactic approaches to breast/ovarian cancer prevention. Monte Carlo simulation was conducted on 4 separate decision models representing prophylactic oophorectomy, prophylactic mastectomy, prophylactic oophorectomy/mastectomy and screening. The use of 3 separate preference assessment methods across different populations of women allows researchers to determine how quality adjusted survival varies according to clinical strategy, method of preference assessment and the population from which preferences are assessed. ^

Revising the National Ambient Air Quality Standards: The integration of science and policy

Under the Clean Air Act, Congress granted discretionary decision making authority to the Administrator of the Environmental Protection Agency (EPA). This discretionary authority involves setting standards to protect the public's health with an "adequate margin of safety" based on current scientific knowledge. The Administrator of the EPA is usually not a scientist, and for the National Ambient Air Quality Standard (NAAQS) for particulate matter (PM), the Administrator faced the task of revising a standard when several scientific factors were ambiguous. These factors included: (1) no identifiable threshold below which health effects are not manifested, (2) no biological basis to explain the reported associations between particulate matter and adverse health effects, and (3) no consensus among the members of the Clean Air Scientific Advisory Committee (CASAC) as to what an appropriate PM indicator, averaging period, or value would be for the revised standard. ^ This project recommends and demonstrates a tool, integrated assessment (IA), to aid the Administrator in making a public health policy decision in the face of ambiguous scientific factors. IA is an interdisciplinary approach to decision making that has been used to deal with complex issues involving many uncertainties, particularly climate change analyses. Two IA approaches are presented; a rough set analysis by which the expertise of CASAC members can be better utilized, and a flag model for incorporating the views of stakeholders into the standard setting process. ^ The rough set analysis can describe minimal and maximal conditions about the current science pertaining to PM and health effects. Similarly, a flag model can evaluate agreement or lack of agreement by various stakeholder groups to the proposed standard in the PM review process. ^ The use of these IA tools will enable the Administrator to (1) complete the NAAQS review in a manner that is in closer compliance with the Clean Air Act, (2) expand the input from CASAC, (3) take into consideration the views of the stakeholders, and (4) retain discretionary decision making authority. ^

A qualitative analysis of leadership styles and the selection of quality improvement in primary care practice

In the Practice Change Model, physicians act as key stakeholders, people who have both an investment in the practice and the capacity to influence how the practice performs. This leadership role is critical to the development and change of the practice. Leadership roles and effectiveness are an important factor in quality improvement in primary care practices.^ The study conducted involved a comparative case study analysis to identify leadership roles and the relationship between leadership roles and the number and type of quality improvement strategies adopted during a Practice Change Model-based intervention study. The research utilized secondary data from four primary care practices with various leadership styles. The practices are located in the San Antonio region and serve a large Hispanic population. The data was collected by two ABC Project Facilitators from each practice during a 12-month period including Key Informant Interviews (all staff members), MAP (Multi-method Assessment Process), and Practice Facilitation field notes. This data was used to evaluate leadership styles, management within the practice, and intervention tools that were implemented. The chief steps will be (1) to analyze if the leader-member relations contribute to the type of quality improvement strategy or strategies selected (2) to investigate if leader-position power contributes to the number of strategies selected and the type of strategy selected (3) and to explore whether the task structure varies across the four primary care practices.^ The research found that involving more members of the clinic staff in decision-making, building bridges between organizational staff and clinical staff, and task structure are all associated with the direct influence on the number and type of quality improvement strategies implemented in primary care practice.^ Although this research only investigated leadership styles of four different practices, it will offer future guidance on how to establish the priorities and implementation of quality improvement strategies that will have the greatest impact on patient care improvement. ^

A review of economic analysis in the vaccination program; decision making and governance: Adivisory Committee on Immunization Practices (ACIP)

The Advisory Committee on Immunization Practices (ACIP) develops written recommendations for the routine administration of vaccines to children and adults in the U.S. civilian population. The ACIP is the only entity in the federal government that makes such recommendations. ACIP elaborates on selection of its members and rules out concerns regarding its integrity, but fails to provide information about the importance of economic analysis in vaccine selection. ACIP recommendations can have large health and economic consequences. Emphasis on economic evaluation in health is a likely response to severe pressures of the federal and state health budget. This study describes the economic aspects considered by the ACIP while sanctioning a vaccine, and reviews the economic evaluations (our economic data) provided for vaccine deliberations. A five year study period from 2004 to 2009 is adopted. Publicly available data from ACIP web database is used. Drummond et al. (2005) checklist serves as a guide to assess the quality of economic evaluations presented. Drummond et al.'s checklist is a comprehensive hence it is unrealistic to expect every ACIP deliberation to meet all of their criteria. For practical purposes we have selected seven criteria that we judge to be significant criteria provided by Drummond et al. Twenty-four data points were obtained in a five year period. Our results show that out of the total twenty-four data point‘s (economic evaluations) only five data points received a score of six; that is six items on the list of seven were met. None of the data points received a perfect score of seven. Seven of the twenty-four data points received a score of five. A minimum of a two score was received by only one of the economic analyses. The type of economic evaluation along with the model criteria and ICER/QALY criteria met at 0.875 (87.5%). These three criteria were met at the highest rate among the seven criteria studied. Our study findings demonstrate that the perspective criteria met at 0.583 (58.3%) followed by source and sensitivity analysis criteria both tied at 0.541 (54.1%). The discount factor was met at 0.250 (25.0%).^ Economic analysis is not a novel concept to the ACIP. It has been practiced and presented at these meetings on a regular basis for more than five years. ACIP‘s stated goal is to utilize good quality epidemiologic, clinical and economic analyses to help policy makers choose among alternatives presented and thus achieve a better informed decision. As seen in our study the economic analyses over the years are inconsistent. The large variability coupled with lack of a standardized format may compromise the utility of the economic information for decision-making. While making recommendations, the ACIP takes into account all available information about a vaccine. Thus it is vital that standardized high quality economic information is provided at the ACIP meetings. Our study may provide a call for the ACIP to further investigate deficiencies within the system and thereby to improve economic evaluation data presented. ^