EPIDEMIOLOGY AND PUBLIC POLICY

ROLES OF EPIDEMIOLOGY
Historically, epidemiology investigations are initiated to address emerging challenges related to human disease and public health Epidemiological studies relate information to practitioners in clinical medicine community health workers disease control officials health prevention advocates

ROLES OF EPIDEMIOLOGY
Epidemiologic findings have applicability and the ability to alleviate public health problems through policy formation and evaluation Epidemiology provides a basis and rationale for public policy by providing data for prevention efforts conducting outcomes research in clinical medicine promoting risk assessments resolving scientific conflict through meta-analyses providing evidence for litigation

INTERSECTIONS OF EPIDEMIOLOGY & POLICY

Functional Status Morbidity Mortality Rates Trends Evaluation of Interventions in Practice Modify or Maintain Priorities Actions

Determinants of Health High Risk Groups

Evidence for Interventions

Shapiro, S. Epidemiology and Public Policy. Am J Epid. 1991;134:1057-1061.

DATA FOR PREVENTION

EPIDEMIOLOGY AND PREVENTION

Epidemiology is considered the basic science of prevention and thus identifies populations at increased risk for certain disease outcomes ascertains cost and benefits of reducing specific exposures assesses the strength of exposure-outcome associations and its limit on inferences Screening, counseling and immunization are considered primary prevention tools

EPIDEMIOLOGY AND PREVENTION

Prevention is justified based on

seriousness of disease to individuals and population cost in dollars and in terms of human suffering strength of causal relationship between a particular exposure and disease etiology benefits to early intervention
THE ROLE OF EPIDEMIOLOGY IS TO ASSESS THESE FACTORS

EPIDEMIOLOGY AND PREVENTION

Main question in prevention efforts: should high risk groups be targeted or should efforts extend evenly to general population? It is possible to combine approaches and extend certain measures evenly in the population while addressing the specific concerns of a high risk group

Cost/benefit analyses often conflict with ethical responsibilities and legal requirements

EPIDEMIOLOGY AND PREVENTION - an example

As mentioned, epidemiology uses immunization as a major tool of prevention of disease GLOBAL ERADICATION OF SMALLPOX Profile: ancient viral disease unique to humans with airborne transmission Vaccine is highly effective (100% immunity for 3 years which slowly wanes over 10 years) cheaply produced and freeze-dried for easy transport efficacy never tested in a randomized trial

EPIDEMIOLOGY AND PREVENTION - an example

HISTORICAL NOTES

Edward Jenner (1749-1823): noted protective effect of cowpox on milkmaids and began innoculations of humans with cowpox matter 19th Century Europe: legally compulsory smallpox vaccinations by 1850 1940s: most industrialized countries free of endemic smallpox 1966: World Health Assembly (WHA) makes global eradication a priority

EPIDEMIOLOGY AND PREVENTION - an example

THE ROAD TO ERADICATION 1960s: epidemiologists carry out surveillance, case-detection & outbreak containment efforts as cases dwindled specimens sent to Atlanta and Moscow for confirmation 1970s: slowly countries declared free of contamination when 2 years passed from last case 1978: two cases occur in Birmingham England in a lab outbreak - the last cases thus far 1980: 33rd World Health Assembly declared freedom from smallpox

EPIDEMIOLOGY AND PREVENTION - an example

THE POLICY LINK - EPIDEMIOLOGY & SMALLPOX

Epidemiology collects data - pockmark surveys - morbidity and mortality counts

WHO creates policies - compulsory vaccinations - detection and containment strategies SMALL POX IS ERADICATED

United States Department of Health and Human Services (HSS) - Donna Shalala
Administration for Children and Families Administration for Aging

Agency for Health Care Policy and Research

Agency for Toxic Substances and Disease Registry Center for Disease Control

United States Department of Health and Human Services (HSS) - Cont

Food and Drug Administration
Health Care Financing Administration Indian Health National Institute of Health National Institute of Environmental Health Services Substance Abuse and Mental Health Services

OUTCOMES RESEARCH

OUTCOMES RESEARCH

Epidemiological Studies

Clinical Trials

Effectiveness Studies

Psychometrics (e.g. Quality of Life): Functional Status

Review of Drug and Nondrug Interventions

Economic Evaluation

Disease management Strategy (Standards of Care/Guidelines)

Application

Outcomes Management
Process Changes Utilization Review/ Utilization Evaluation Compliance/Persistence Clinical/Laboratory Markers

Improved Quality of Care and Patient Outcomes

Four-stage framework for public health policy development and evaluation

I. Identification of Health Risk/Preventive Options II. Intervention(Program) Development III. Policy Development IV. Policy Enactment and Assurance

Identify susceptible/ priority populations

Epidemiologic research (etiology) Examine options/ channels Assess high-risk versus population approach Determine behavioral science theoretical underpinnings

Examine options

Enhance coalitions

Develop coalitions

Market the message

Medical/Basic Science Research

Seek input from policy makers

Involve the media

Collect data planning data (e.g. key informant interviews member surveys)

Make strategic use of data

Effective

Ineffective
Source: Brownson, et al (1997)

Evaluation (Program/Policy) Include cost-effective analysis

EPIDEMIOLOGY AND OUTCOMES RESEARCH

Epidemiology provides data essential in evaluating the effectiveness of different therapy models used in clinical medicine such as length of life after therapy complications of disease with and without therapy complications of medical care cost of medical care psychosocial elements of therapy

EPIDEMIOLOGY AND OUTCOMES RESEARCH

Primary vehicle for assessing effectiveness is the randomized trial, yet they have several drawbacks long intervals between initiation of trials and the availability of results strong pressure to assess costs vs. benefits that interferes with scientific outcome of trial Recently, non-randomized observational studies have been used to assess the effectiveness of care or treatment efforts

EPIDEMIOLOGY AND OUTCOMES RESEARCH

Non-randomized observational studies Use large existing databases available from health insurers, health maintenance organizations, drug manufacturers, etc. often determine effectiveness quicker and with less cost than randomized trials

EPIDEMIOLOGY AND OUTCOMES RESEARCH

Drawbacks to outcomes research include In the absence of randomization the potential for significant selection bias exists Records utilized often designed for billing or other administrative purposes and not for research may lack information critical to epidemiologic investigation such as confounders

OUTCOMES RESEARCH - an example

Grumbach et al. in 1996 found that patients served by medical providers with higher annual bypass surgery volumes had lower mortality rates
SOURCE: computerized hospital discharge records submitted to state agencies in New York and California and provincial health plans in Ontario, British Columbia, and Manitoba TIMEFRAME: retrospectively ascertained all coronary artery bypass surgeries done between 1987 and 1989
Grumbach, K. et al. Regionalization of cardiac surgery in the US and Canada... JAMA. 1996;274:1282-1288.

OUTCOMES RESEARCH - an example

Results
In NY and California 60% of all bypass surgeries were performed in hospitals performing over 500 surgeries annually, yet in Canada only 26% of all surgeries met this threshold Risk-adjusted mortality rates were consistently lower in hospitals performing over 500 surgeries annually

Based on the results of this epidemiologic investigation, health care policies concerning cardiac care facility location and admission can be created

Insert AHRQ logo here

AHRQ, part of the U.S. Department of Health and Human Services, is the lead agency charged with supporting research designed to improve the quality of health care reduce its cost broaden access to essential services

AHRQ's broad programs of research bring practical, science-based information to medical practitioners consumers and other health care purchasers

Insert AHRQ logo here

The Agency is comprised of 10 major functional components: Immediate Office of the Director The Office of Management The Office of Research Review, Education, and Policy The Office of Health Care Information The Center for Practice and Technology Assessment The Center for Outcomes and Effectiveness Research The Center for Primary Care Research The Center for Organization and Delivery Studies The Center for Cost and Financing Studies The Center for Quality Measurement and Improvement

http://www.ahcpr.gov/clinic/

Outcomes and Effectiveness Research 1990-1996

Assessment of Liver Transplantation Bone Densitometry: Patients with End-Stage Renal Disease Carotid Endarterectomy Combined Liver-Kidney Transplantation Diagnosis and Treatment of Impotence Electroencephalographic (EEG) Video Monitoring External and Implantable Infusion Pumps Extracranial-Intracranial Bypass to Reduce the Risk of Ischemic Stroke Hyperthermia in Conjunction with Cancer Chemotherapy Institutional and Patient Criteria for Heart-Lung Transplantation Isolated Pancreas Transplantation Lung-Volume Reduction Surgery for End-Stage COPD Magnetic Resonance Angiography: Vascular and Flow Imaging

META-ANALYSIS

META-ANALYSIS
Meta-analysis: an attempt to systematize the process of reviewing the epidemiologic literature on a given topic to resolve inconsistencies of different studies Meta-analysis allows epidemiologic data to be used in policy formation as it
assesses its validity often helps resolve scientific conflict

Meta-analysis is most often used for randomized trials because they are more likely to share a common research design

META-ANALYSIS
Statistical methods in meta-analysis

The most widely used method is the MantelHaenszel technique to give a summary OR and a summary chi square statistic The process is similar to that used in stratified analyses (to identify a confounder) Here the stratification variable is the individual study This techniques allows a weighted summary by sample size of the study(instead of strata sample size)

META-ANALYSIS
Meta-analysis helps to address the following:

Can epidemiologic methods detect small increases in risk? Can investigators reconcile inconsistencies between human and animal models? Can incomplete or equivocal epidemiologic data be used? Can results be interpreted with epidemiologic studies disagree?

META-ANALYSIS
Advantages:

Allows for aggregation of results from a set of similar studies (weighted by sample size)
Increases statistical power and thus can detect associations hidden in individual studies (especially important for subgroups where sample size is often small)

Helps to give an overall perspective on an issue when individual studies disagree

META-ANALYSIS
Disadvantages:

Often only published studies are included and thus may skew results
Individual studies may vary in quality

When RRs or ORs from individual studies differ, combining them in a meta-analysis may mask their unique qualities Results of a meta-analysis are not reproducible by other investigators

META-ANALYSIS
Publication bias: the tendency for articles with positive associations or increased risks to be published more frequently than those that report negative association or no-effect Articles regarding environmental risks and the results of clinical trials especially susceptible This bias results from: Investigators only including certain findings Journals only publishing findings of perceived interest

META-ANALYSIS
Publication bias and meta-analysis Problem in meta-analysis because selective inclusion of only studies showing positive results will skew overall conclusions in the same direction A meta-analysis can include unpublished results but they have not be subjected to peer-review and may have questionable quality

META-ANALYSIS
the Cochrane Collaboration http://www.cochrane.de/ Founded in 1992 Based on works from the Cochrane Centre in the United Kingdom An international network for the production and dissemination of meta-analyses Prepares meta-analyses on relevant health care interventions and supplies results to the general public via print and computer networks

The Nine Principles of the Cochrane Collaboration The Cochrane Collaboration ...is an international organization that aims to help people make well informed decisions about health care by preparing, maintaining and ensuring the accessibility of systematic reviews of the effects of health care interventions. The Collaboration is being built on nine principles: collaboration building on the enthusiasm of individuals avoiding duplication minimizing bias keeping up to date ensuring relevance ensuring access continually improving the quality of its work continuity

META-ANALYSIS - an example
EXAMPLE: Results of 7 case-control studies on relating a history of sunburn in childhood to the incidence of melanoma assembled into a metaanalysis format Individual ORs are not always statistically significant alone, but when combined with others to create larger sample sizes, the overall Mantel Haenszel Odds Ratio is statistically significant
Elwood, M. Critical Appraisal of Epidemiological Studies and Clinical Trials. Oxford Univ. Press. 1998. P212.

META-ANALYSIS - an example
Study 1 2 3 4 5 6 7 OR 1.30 1.20 3.70 2.40 6.50 1.49 1.60 95% CI lower upper 0.90 1.80 0.60 2.30 2.30 6.10 0.80 7.30 3.40 12.30 0.97 2.32 1.00 2.60 .5 CI Range 1 13

MH OR = 1.88 95% CI for MH OR = (1.56-2.28)

the MH OR is highly significant

A SELECTED RESEARCH INSTITUTE

http://www.tanglewood.net/ Tanglewood Research is dedicated to developing, testing, training, and marketing highly effective educational materials for preventing drug use, violence, delinquency, and premature sexual activity among teens. Often this research is in the form of metaanalyses that combine research investigations from multiple source populations.

A Meta-analysis of Project DARE Outcome Evaluations

BACKGROUND: DARE is a drug abuse prevention program delivered by police officers. It is one of the most widely disseminated drug abuse prevention efforts in the world.

The DARE Core Curriculum is most frequently delivered in the last year of elementary school, during fifth or sixth grade.
This paper presents analyses which synthesize eight scientifically rigorous evaluations of the DARE Core Curriculum. These findings were compared to the findings of twenty-five similar evaluation studies of other programs delivered in upper elementary school.

EPIDEMIOLOGY AND LITIGATION

EPIDEMIOLOGY AND LITIGATION

In recent years litigation has become a main avenue for policy formation and public health has been no exception Epidemiology plays an important role by providing scientific evidence in arenas such as: dioxin silicone breast implants electromagnetic fields tobacco helmet safety

EPIDEMIOLOGY AND LITIGATION

Drawbacks to epidemiology in the courtroom

Epidemiology presents data about groups whereas a trial often concerns specific individuals
Legal definition of causality often difficult to obtain in epidemiology attributable risk of >50% based on U.S. Surgeon Generals guidelines for causality Recently, however, epidemiologic studies have become increasingly accepted (especially in toxicology) as authority in their field

EPIDEMIOLOGY AND LITIGATION

Case of Daubert vs. Merrell Dow Pharmaceuticals

Established in 1993 that an experts testimony rests only on a reliable foundation that is relevant to the task at hand and thus does not have to be generally acceptable
Relies on judges to assess whether testimony is reasonable and scientifically sound

Resulted in an epidemiology section to be included in the Federal Judicial Centers Manual on Scientific Evidence for Judges