An overview and discussion of the Patient-Centered Outcomes Research Institute's decision aid portfolio.

Decision aids (DAs) help patients make informed healthcare decisions in a manner consistent with their values and preferences. Despite their promise, DAs developed with public research dollars are not being implemented and adopted in real-world patient care settings at a rate consistent with which they are being developed. To appraise the sum of the parts of the portfolio and create a strategic imperative surrounding future funding, the Patient-Centered Outcomes Research Institute (PCORI) tasked the Duke Evidence Synthesis Group with evaluating its DA portfolio.

Models in the development of clinical practice guidelines.

Clinical practice guidelines should be based on the best scientific evidence derived from systematic reviews of primary research. However, these studies often do not provide evidence needed by guideline development groups to evaluate the tradeoffs between benefits and harms. In this article, the authors identify 4 areas where models can bridge the gaps between published evidence and the information needed for guideline development applying new or updated information on disease risk, diagnostic test properties, and treatment efficacy; exploring a more complete array of alternative intervention strategies; assessing benefits and harms over a lifetime horizon; and projecting outcomes for the conditions for which the guideline is intended.

Comparative effectiveness research in clinical practice.

The Agency for Healthcare Research and Quality (AHRQ) has funded systematic reviews of comparative effectiveness research in 17 areas over the last 10 years as part of a federal mandate. These reviews provide a reliable and unbiased source of comprehensive information about the effectiveness and risks of treatment alternatives for patients and clinicians. This article describes comparative effectiveness research, provides an overview of how physicians can use it in clinical practice, and references important contributions made by the Minnesota Evidence-based Practice Center.

Comparative effectiveness research in practice and policy for radiation oncology.

Interest in comparative effectiveness research (CER) has increased dramatically over the past decade, yet perceptions about what comprises CER varies. CER has several attributes relevant to practice and policy: (1) The goal of CER is to inform decisions about health care. (2) Literature synthesis is used in addition to primary research.

Chapter 10: deciding whether to complement a systematic review of medical tests with decision modeling.

Limited by what is reported in the literature, most systematic reviews of medical tests focus on "test accuracy" (or better, test performance), rather than on the impact of testing on patient outcomes. The link between testing, test results and patient outcomes is typically complex: even when testing has high accuracy, there is no guarantee that physicians will act according to test results, that patients will follow their orders, or that the intervention will yield a beneficial endpoint. Therefore, test performance is typically not sufficient for assessing the usefulness of medical tests.

Inventory of data sources for estimating health care costs in the United States.

Objective: To develop an inventory of data sources for estimating health care costs in the United States and provide information to aid researchers in identifying appropriate data sources for their specific research questions.

Methods: We identified data sources for estimating health care costs using 3 approaches: (1) a review of the 18 articles included in this supplement, (2) an evaluation of websites of federal government agencies, non profit foundations, and related societies that support health care research or provide health care services, and (3) a systematic review of the recently published literature. Descriptive information was abstracted from each data source, including sponsor, website, lowest level of data aggregation, type of data source, population included, cross-sectional or longitudinal data capture, source of diagnosis information, and cost of obtaining the data source.

Economic evaluation alongside a clinical trial of psycho-educational interventions to improve adjustment to survivorship among patients with breast cancer.

Purpose: There is little economic research on psychosocial interventions. We aimed to collect data alongside a randomized trial to compare the costs and benefits of three psycho-educational strategies to improve transition to cancer survivorship.

Methods: We evaluated the incremental delivery costs per unit increase in energy (using the Medical Outcomes Study vitality scale) or decrease in distress (from the Revised Impact of Events Scale) in the 6 months postintervention.

Health limitations and quality of life associated with cancer and other chronic diseases by phase of care.

Objective: To estimate health limitations and health-related quality of life (HRQL) associated with cancer and other chronic conditions in a nationally representative sample within a phase-of-care framework.

Study Design And Setting: We used a nested case-control design to assess health limitations and HRQL in individuals reporting a breast, colorectal, prostate, or lung cancer diagnosis, or a diagnosis of arthritis, diabetes, heart disease, or hypertension compared with similar controls without these conditions. All subjects were selected from the 1986-1994 National Health Interview Surveys linked to mortality files in 1995, and classified into the initial, continuing, or last year of life phase of care.

Report of nationally representative values for the noninstitutionalized US adult population for 7 health-related quality-of-life scores.

Background: Despite widespread use of generic health-related quality-of-life (HRQoL) scores, few have publicly published nationally representative US values.

Purpose: To create current nationally representative values for 7 of the most common HRQoL scores, stratified by age and sex.

Methods: The authors used data from the 2001 Medical Expenditures Panel Survey (MEPS) and the 2001 National Health Interview Survey (NHIS), nationally representative surveys of the US noninstitutionalized civilian population: The MEPS was used to calculate 6 HRQoL scores: categorical self-rated health, EuroQoL-5D with US scoring, EuroQoL-5D with UK scoring, EuroQol Visual Analog Scale, mental and physical component summaries from the SF-12, and the SF-6D.

Process utility in breast biopsy.

Purpose: To determine whether the waiting trade-off (WTO) is feasible for differentiating short-term biopsy preferences in an acute situation where anxiety is the symptomatic disease state.

Methods: 75 women with past experience of either breast core-needle biopsy (CNB), more invasive excisional surgical biopsy (EXB), or both, had telephone WTO assessments. Patients' baseline and test-related anxiety were valued by time trade-off (TTO) used to scale the WTO.

Cost-effectiveness analysis based on the atypical squamous cells of undetermined significance/low-grade squamous intraepithelial lesion Triage Study (ALTS).

Background: The ALTS (atypical squamous cells of undetermined significance [ASCUS] and low-grade squamous intraepithelial lesion [LSIL] Triage Study) suggests that, for women diagnosed with ASCUS, human papillomavirus (HPV) DNA testing followed by referral to colposcopy of only those women with oncogenic HPV (i.e., HPV DNA testing) is as effective at detecting cervical intraepithelial neoplasia (CIN) 3 or cancer (CIN3+) as referring all women with ASCUS for immediate colposcopy.

Patterns of care in early-stage breast cancer survivors in the first year after cessation of active treatment.

Purpose: Patterns of health care use have not been well described for breast cancer survivors. The purpose of this study was to describe the health service use in a survivor cohort.

Patients And Methods: Women with stage I or II breast cancer were recruited (n = 558) after primary treatment for a multicenter, randomized trial of psychoeducational interventions for facilitating transition to survivorship; 418 women completed the study.

A national catalog of preference-based scores for chronic conditions in the United States.

Background: The variability in preferences used in quality-adjusted life-years estimation jeopardizes the comparability of cost-effectiveness analyses and has led the Panel on Cost-Effectiveness in Health and Medicine (the PCEHM) to call for a catalog of "off-the-shelf" preference weights associated with conditions that can be used by health researchers without the burden of collecting primary data.

Objective: The current research responds to the call by developing a nationally representative catalog of preference-based scores for chronic conditions and associated sociodemographic characteristics.

Methods: The authors report the EQ-5Dindex scores of chronic conditions and associated sociodemographic characteristics in the nationally representative Medical Expenditure Panel Survey (MEPS).

Federal sponsorship of cost-effectiveness and related research in health care: 1997-2001.

Objectives: To describe recent federal sponsorship of cost-effectiveness and related health economics research to provide insight into the functioning of existing research support systems and assess the roles of federal health agencies.

Methods: Using the PubMed database, we identified cost-effectiveness and related publications citing support from a US government entity and published during the period of 1997 through 2001, and audited them for information on funding sources, study type, and content focus.

Results: Five Department of Health and Human Services agencies and centers and the Veterans Administration are cited as funders in 74% of 520 federally supported health economics publications we identified.

Geographic disparities in cervical cancer mortality: what are the roles of risk factor prevalence, screening, and use of recommended treatment?

Context: Despite advances in early detection and prevention of cervical cancer, women living in rural areas, and particularly in Appalachia, the rural South, the Texas/Mexico border, and the central valley of California, have had consistently higher rates of cervical cancer mortality than their counterparts in other areas during the past several decades.

Methods: This paper reviews the published literature from 1966 to July 2002 to assess three potential pathways underlying this excess mortality--high human papilloma virus (HPV) prevalence, lack of or infrequent screening and advanced disease at diagnosis, and under-use of recommended treatment and shorter survival.

Findings: Living in rural areas may impose barriers to cervical cancer control, including lack of transportation and medical care infrastructures.

Burden of illness in cancer survivors: findings from a population-based national sample.

Background: Population trends in aging and improved cancer survival are likely to result in increased cancer prevalence in the United States, but few estimates of the burden of illness among cancer survivors are currently available. The purpose of this study was to estimate the burden of illness in cancer survivors in a national, population-based sample.

Methods: A total of 1823 cancer survivors and 5469 age-, sex-, and educational attainment-matched control subjects were identified from the 2000 National Health Interview Survey.

Predicting EuroQoL EQ-5D preference scores from the SF-12 Health Survey in a nationally representative sample.

Purpose: To predict the EuroQoL EQ-5D utility index from the SF-12 Health Survey for a US national sample of adults.

Methods: The authors used the 2000 Medical Expenditure Panel Survey to examine the relationship between instruments. Linear regression was used to predict EQ-5D scores from Physical Component Summary (PCS) and Mental Component Summary (MCS) scores of the SF-12.

Short-term impact of cancer prevention and screening activities on quality of life.

Purpose: There are few data on the short-term effects of participating in cancer prevention activities, undergoing genetic risk assessment, or having routine screening. The objective of this article is to systematically review existing research on short-term effects of prevention, genetic counseling and testing, and screening activities on quality of life.

Methods: We conducted a MEDLINE search for original research studies that were published between January 1, 1985, and December 31, 2002, and conducted in North America or Western Europe.

Demographic variation in SF-12 scores: true differences or differential item functioning?

Background: Demographic differences have been reported in summary measures of physical and mental health based on the SF-12 instrument.

Objectives: This study examines the extent to which differential item functioning (DIF) contributes to observed subgroup differences in health status. DIF refers to situations in which the psychometric properties of items are not invariant across different groups.

Acceptability of diagnostic tests for breast cancer.

Purpose: To assess the acceptability of new non-invasive breast cancer diagnostic tests intended to triage women in need of biopsy.

Methods: Women who had abnormal screening tests and had been recommended to have a biopsy were invited to receive digital mammography, magnetic resonance imaging (MRI), and nuclear medicine evaluation (Tc-99m-sestamibi scanning) before biopsy. Participants completed a questionnaire about satisfaction and acceptability of the procedures.

Development of an Interactive Decision Aid for Female BRCA1/BRCA2 Carriers.

Shared decision making between patients and providers is becoming increasingly common, particularly when there is no clear preferred course of action. As a result, decision aids are being adopted with growing frequency and have been applied to many medical decision-making issues. One such issue where there is uncertainty is breast cancer risk management among BRCA1/BRCA2 carriers.

Process utility for imaging in cerebrovascular disease.

Rationale And Objectives: The morbidity associated with a diagnostic test can influence its cost-effectiveness, but the quantification of that morbidity is controversial. Accounting for pain and invasiveness requires the measurement of "process utility" in addition to the expected value of testing. An original time trade-off variant was applied to the imaging evaluation of cerebrovascular disease, for which differences in morbidity are important to patients.

Costs and benefits of different strategies to screen for cervical cancer in less-developed countries.

Background: About 80% of cervical cancers occur in less-developed countries. This disproportionate burden of cervical cancer in such countries is due mainly to the lack of well-organized screening programs. Several cervical cancer screening strategies have been proposed as more cost-effective than cytology screening.

Benefits and costs of using HPV testing to screen for cervical cancer.

Context: Despite quality assurance standards, Papanicolaou (Pap) test characteristics remain less than optimal.

Objective: To compare the societal costs and benefits of human papillomavirus (HPV) testing, Pap testing, and their combination to screen for cervical cancer.

Design, Setting, And Population: A simulation model of neoplasia natural history was used to estimate the societal costs and quality-adjusted life expectancy associated with 18 different general population screening strategies: Pap plus HPV testing, Pap testing alone, and HPV testing alone every 2 or 3 years among hypothetical longitudinal cohorts of US women beginning at age 20 years and continuing to 65 years, 75 years, or death.