DA3 Using Community Pharmacies to Conduct Outcomes Research

Studies of effectiveness require that health outcomes be measured in heterogeneous samples of patients. The Pharmacy Medication Monitoring Program (PMMP) is an outcomes research program which uses community pharmacies to recruit study subjects, resulting in a broad sample of patients treated by physicians with diverse practice patterns. Patients are followed prospectively and undergo repeat telephone interviews at specified intervals. The purpose of this workshop is to demonstrate how community pharmacies can be used to perform high quality, prospective outcomes research. The methods for establishing a network of pharmacies, recruiting patients, and obtaining patient informed consent will be described. The procedures for developing telephone questionnaires and for collecting data on a broad range of topics, such as patient demographics, drug utilization and compliance, prescribing patterns, health services utilization, adverse events, quality of life, out-of-pocket expenditure and productivity losses will be discussed. Finally, the applications of community pharmacy-based outcomes research studies will be presented. These include pharmacoeconomic evaluations for formulary registration, drug utilization review for improving therapeutic regimens, developing disease management strategies for optimizing care, patient profiling for investigating utilization and compliance patterns and measuring health outcomes to assess the impact of health policy decisions. This workshop will benefit industrial and academic researchers engaged in prospective pharmacoeconomic assessments, health services evaluations and outcomes research. Individuals interested in outcomes research methodology and the relationship between outcomes research and health policy decision-making may also benefit from attending.     

DA2 The Role of Patient Registries in Disease Management and Outcomes Research

Although observational studies are a relatively inexpensive and rapid alternative to randomized controlled trials, critics argue that observational studies lack internal validity. For example, indication bias may limit the reliability of outcomes data from observational studies on the cost or safety of alternative pharmacotherapy. The workshop will focus on the novel use of data on prior medications to document the extent of confounding by indication. Current research on use of anti-hypertensive and antianginal medications in a Medicaid population will be used to illustrate recommended methods for designing and conducting observational studies. Topics covered will include assessing and classifying the duration and classes of prior medication history, sequencing of risk factors and adjusting for severity of disease. The on-going controversy over the safety of calcium channel blockers will be examined in light of evidence on confounding by indication. The presenters' own research will be used to explore the evidentiary basis for current claims and counter claims as well as the weakness of data on the key intervening variable-exposure to the study drugs. The workshop material is aimed at researchers with hands-on experience using administrative databases as well as industry sponsors of outcome studies. The workshop addresses the themes of enhancing the usefulness of outcomes research for providers and insurers by strengthening current methods for identifying and eliminating systematic biases.     

PMD11 Use of Administrative Databases in Saskatchewan, Canada, for Pharmacoeconomic and Outcomes Research

Many urologists have limited resources to track and analyze the clinical and health-related quality of life outcomes of prostate cancer patients. We developed software that compiles clinical and quality of life data and provides benchmarking capabilities against a national database of prostate cancer patients (CaPSURE™).
METHODS: We randomly surveyed 50 urologists with a minimum of 5 years in practice, access to a computer in their office, and under the age of 65. To determine which features of a software program would be most interesting to them, urologists rank ordered eight areas of clinical practice: demographics, clinical staging, imaging, treatment, symptoms, medications, quality of life, and patient satisfaction. A software prototype (CaPSURE POS™) was designed based on survey results and beta-tested with urologists. Physicians enter data on prostate cancer patients prospectively at the time of office visits. Patients record responses on a quality-of-life instrument. Individual and group practice data can be tabulated and benchmarked against the national CaPSURE™ database.
RESULTS: 80% of urologists stated they would likely use the patient outcomes software in their practice. The software features described as most useful included: clinical staging, imaging, treatment, and quality of life. Major software components include: PSA graphing, the Partin Nomogram, treatment patterns by demographics/disease stage, survival rates, resource use, and quality of life measurements.
CONCLUSIONS: The ability of CaPSURE POS™ to analyze treatment and quality of life outcomes may be of significant value for urologists in a competitive health care environment and to improve outcomes for patients with prostate cancer.     

DA7 Prospective, Naturalistic Outcomes Measurement: The Schizophrenia Care and Assessment Program (SCAP)

Traditional state Medicaid programs that adopt an open managed care model must adapt their oversight from a single drug formulary to multiple formularies. Following the workshop, participants should be able to identify and describe successful strategies for obtaining and analyzing data needed to evaluate appropriateness of multiple drug formularies. Practical experience with obtaining information and creating a database containing multiple formularies, procedures to incorporate analysis of drug therapy by disease sate, and different methods used to categorize drugs for evaluation will be presented. These will be demonstrated by comparing medications used for the treatment of peptic ulcer disease by Medicaid managed care formularies in the state of Tennessee. This workshop is intended for government and healthcare industry decision makers and others involved in quality control and improvement.     

MM6 Decision Analysis: What is its Utility for Pharmacoeconomic Analysis?

This session is intended for sharing and comparing computer software applications for research, management, and practice. Software applications will be demonstrated for decision analysis, cost effectiveness analysis, multiattribute utility computation, and assessing patient utilities. Desktop applications, will be discussed. Laptop and handheld computer software will be demonstrated. Pharmacoeconomic software allows data to be analyzed from different perspectives: patient, provider, hospital, managed care, and society. Software models also allow assessment of health care products or services from different quantitative perspectives: cost of illness, cost minimization, cost-benefit, cost-effectiveness, and cost-utility. The integration of decision analysis and spreadsheets will also be discussed. Software is utilized to collect information, analyze data, present findings, or educate managers, providers and patients. Pros and cons of each analytical and software approach will be discussed. Participants are encouraged to bring their own laptops to demonstrate their own software or related Internet offerings in an informal roundtable fashion. Software beta versions allowed; "viruses" discouraged.     

CC6 Development of Asthma-Specific Outcomes Measures for Children

To facilitate the evaluation of a new pediatric asthma management program, HUFF and PUFFSM The Children's Asthma Program, a set of children's outcomes surveys, including measures of quality of life (QoL) and self-efficacy, were prepared. Each instrument was pretested through individual cognitive interviews with asthmatic children ranging in age from four to eight years old.
QUESTIONNAIRE 1: The QoL measure, the Childhood asthma Questionnaire–Form A, was developed in England by Davina French and colleagues. Although it was designed to measure both global and asthma-specific QoL in young children, the questionnaire needed to be adapted for use in the U.S. The most interesting cognitive findings pertain to children's ability to select appropriate responses and relate to item content. For example, the youngest children had difficulty distinguishing between certain response categories, and some items were not optimally worded for older children.
QUESTIONNAIRE 2: The original version of the self-efficacy measure was developed by Thomas Creer for use with adults. Because this program is targeted for young children, we initially modified the scale by reducing the number of items and adding graphics to clarify the response categories. Cognitive findings indicated that children had difficulty answering items about situations that did not trigger their asthma. Therefore, the survey was limited to triggers most commonly acknowledged by children. Gate questions were also added to ensure that children would only be asked to provide self-confidence evaluations about their personal triggers. Additional modifications were aimed at making the questions and response categories as concrete as possible.
PSYCHOMETRIC EVALUATION: Psychometric properties of these instruments will be evaluated during the pilot program which is currently under way.     

PMD1 Information Technology in a Large Multi-Site Outcomes Study

The platinum chemotherapeutic compounds (cisplatin and carboplatin) are widely used in the treatment of advanced Non-Small Cell Lung Cancer (NSCLC). The introduction of new agents such as paclitaxel and vinorelbine has resulted in the development of combination regimens with improved response rates and survival. Two commonly used regimens, paclitaxel/carboplatin (TP) and vinorelbine/cisplatin (NP), are compared in this pharma-coeconomic analysis.
METHODS: A meta-analysis of available clinical trials was conducted to estimate the clinical effectiveness of TP and NP. Literature and physician interviews provided information on resource utilization and adverse event management (AEM) for these regimens. Treatment models were populated with Medicare reimbursement figures to compare the expected cost of treatment.
RESULTS: The expected cost of the TP and NP regimens was $19,322 and $20,790, respectively. Although the efficacy of these regimens has not been compared in a randomized trial, meta-analysis of regimented phase II and III studies showed no statistically significant differences in response rates. Therefore, equivalent efficacy is assumed in this cost comparison. A 20% variation in the cost of underlying resources yielded a 7% standard deviation in results. This sensitivity analysis showed that the costs of these regimens are insensitive to variations in underlying parameters.
CONCLUSION: This study suggests that TP is the phar-macoeconomic NSCLC treatment of choice when compared to NP. The analysis reveals that low administration and AEM costs are the key drivers in the lower treatment cost of TP.     

UT2 Practical Applications of the Health Utilities Index

The Health Utilities Index is designed to describe and to quantify the health status and the health-related quality-of-life (HRQOL) of subjects. This validated and reliable instrument has been employed by over 100 research groups worldwide and exists in three formats (face-to-face interview, telephone interview and self-administration). Translations into several languages are also available. As a generic preference-weighted system, the Health Utilities Index not only measures and describes health status, but also provides a quantitative measure of HRQOL as a single summary score based on community preferences for health status. The score, founded on utility theory and anchored to the conventional 0–1 (dead–healthy) scale, is appropriate as a quality-weight in the calculation of quality-adjusted life-years (QALY's). Given that QALYs have been recognized as a universal measure for use in cost-effectiveness/cost-utility analyses and are recommended in the reporting and monitoring of population health, this instrument has wide ranging applications in outcomes and health economic research. This workshop will provide an introduction to the Health Utilities Index and focus on its practical application. We will describe our experiences as they relate to issues such as frequency and mode of administration, patient recall, compliance, sample size considerations, data analysis and interpretation. Citing previous studies, this workshop will demonstrate how the Health Utilities Index can be utilized in prospective clinical research, patient surveys and as a means for developing utility estimates in retrospective health economic models. Researchers and analysts involved in quality-of-life and health economic evaluations will gain a working knowledge of the Health Utilities Index and an appreciation of its diversified use as a generic HRQOL instruments.     

MM1 Monte Carlo Simulation in Health Care Models

In this workshop we will focus on Monte Carlo disease simulations and how they can be used to perform economic evaluations of health care interventions. Monce Carlo disease simulation is a modeling technique that operates on a patient level basis, explicitly estimating the effect of variability among patients in both underlying disease progression patterns and in individual responsiveness to treatments. Typical outputs from these simulations are patient functional status, life years, quality-adjusted life years, and associated costs, all of which can be appropriately discounted. The output information is presented in the form of distributions which can be used to estimate mean or median values and confidence intervals for the outcomes of interest. These results can be used to compute cost-effectiveness ratios and other drug value measures. Monte Carlo disease simulation also allows decision makers to address the question of risk associated with smaller populations that may not tend to the "average" results generated by Markov models or simulations of large populations. In this workshop, we describe how to create a Monte Carlo simulation model and how different types of uncertainly can be incorporated into the model. We will briefly compare and contrast Monte Carlo and Markov simulation techniques. Discussion topics will be illustrated and motivated by an HIV/AIDS model of the effect of combination antiretroviral therapy on viral load and CD4 progression. This workshop should be beneficial to outcomes researchers and health care decision makers who need to incorporate uncertainty about the natural history of a disease and the impact of alternative disease management strategies for individual patients into their drug value analyses.     

MHC2 Medical and Economic Outcomes of Noncompliance with Dilantin in Adult Medicaid Epileptics

Major depressive disorder (MDD) is one of the most prevalent mental disorders in the US with social costs up-wards of $43 billion. The Agency for Health Care Policy and Research has disseminated diagnosis and management guidelines for MDD in primary care.
OBJECTIVE: Our aim was to develop a simulation model to evaluate clinical and economic consequences of following AHCPR treatment recommendations. A secondary objective was to create a tool that could be used by health plan decision-makers to assess the value of alternative treatments for MDD.
METHODS: A discrete state simulation model was developed to evaluate primary care management of adults with MDD following the AHCPR guidelines. The perspective of the model was that of the health plan; the time horizon was 1 year from the initiation of pharmacotherapy. Uncertainty was evaluated using Monte Carlo simulation techniques. Endpoints included clinical remission, hospitalization for MDD, or psychiatric referral for treatment failure. Efficacy and safety data were drawn from published randomized, nonrandomized, and synthesized studies, and cost data were derived from modal reimbursement rates from a large managed care organization in Washington state.
RESULTS: The results of the base case simulation demonstrated that initial treatment of MDD with serotonin reuptake inhibitors provided better clinical outcomes at similar costs when compared to tricyclic antidepressants.
CONCLUSION: Simulation models of treatment guidelines are an important and useful extension of outcomes research because they can simultaneously account for costs and effectiveness not otherwise available from a single published study. Further, models such as this can prove useful to health plan decision-makers interested in the ex ante evaluations of individual antidepresant agents for formulary decisions.     

Cancer Information Seeking and Cancer-Related Health Outcomes: A Scoping Review of the Health Information National Trends Survey Literature

Cancer is a leading cause of death among adults in the United States. Only 54% of U.S. adults reported seeking cancer information in 2014. Cancer information seeking has been positively associated with cancer-related health outcomes such as screening adherence. We conducted a scoping review of studies that used data from the Health Information National Trends Survey (HINTS) in order to examine cancer information seeking in depth and the relationship between cancer information seeking and cancer-related health outcomes. We searched five databases and the HINTS website. The search yielded a total of 274 article titles. After review of 114 de-duplicated titles, 66 abstracts, and 50 articles, 22 studies met inclusion criteria. Cancer information seeking was the outcome in only four studies. The other 18 studies focused on a cancer-related health outcome. Cancer beliefs, health knowledge, and information seeking experience were positive predictors of cancer information seeking. Cancer-related awareness, knowledge, beliefs, preventive behaviors, and screening adherence were higher among cancer information seekers. Results from this review can inform other research study designs and primary data collection focused on specific cancer sites or aimed at populations not represented or underrepresented in the HINTS data (e.g., minority populations, those with lower socioeconomic status).