Standards for the Socioeconomic Evaluation of Health Care Services

Over the past decades, health care delivery - once characterized by clearly defined relationships between medical professionals, regulators, and industr- has become much more complex. Traditional roles and relationships are changing and new decision-makers are entering the scene. They bring into the discussion the need for cost containment and the changing perceptions of the public with regard to the risks and benefits of health care outcomes. As benefits of medical care are increasingly questioned and as scepticism and fear of advanced technologies are demonstrated by a growing body of people, decision making must move beyond medical concerns to encompass economic, political, and sociological considera­ tions. This evolution has also affected the pharmaceutical industry. Public percep­ tion of responsibility for product safety is no longer limited to regulators and physi­ cians. Manufacturers, previously unencumbered by social policies, governmental preoccupations, or public expectations, are now held accountable for product safety. As a certain amount of risk acceptance is, however, a prerequisite for the further development of health care goods, it has to be carefully balanced against society'S demand for safety. To weigh risks against benefits, to define acceptable risk, and to exclude what no longer falls within this category remain perpetual challenges. Accordingly, health care outcomes have to be assessed not only from a clinical point of view, but also from an economic and societal perspective. The assessment of drug risks and benefits has become an important political issue world-wide.

Contenu

Socioeconomic Evaluations: an Executive Summary.- I: Guidelines for the Evaluator.- 1 Introduction to Socioeconomic Evaluations.- 1.1 Introduction.- 1.2 Brief History of Socioeconomic Evaluations.- 1.3 Compromises and Choices in Socioeconomic Evaluation.- 1.4 Why Socioeconomic Evaluations Are Performed.- 1.5 Organization of the Text.- 2 Concepts in Socioeconomic Evaluation.- 2.1 Introduction.- 2.2 Generating Socioeconomic Hypotheses.- 2.3 Socioeconomic Concepts.- 2.3.1 Costs.- 2.3.2 Consequences.- 2.3.3 Marginal Analysis.- 2.4 Discounting and the Dimension of Time.- 2.5 Conclusion.- 3 Types of Socioeconomic Evaluation.- 3.1 Introduction.- 3.2 Types of Socioeconomic Evaluation.- 3.2.1 Cost-Benefit Analysis.- 3.2.2 Cost-Utility Analysis.- 3.2.3 Cost-Effectiveness Analysis.- 3.2.4 Cost-Minimization Analysis.- 3.2.5 Cost of Illness Studies.- 3.2.6 Quality of Life Studies.- 3.2.7 Budgetary Analysis.- 3.3 Conclusion.- 4 Framework of the Evaluation.- 4.1 Introduction.- 4.2 Defining the Research Question.- 4.3 The Perspective.- 4.3.1 The Perspective of Society.- 4.3.2 The Perspective of the Third Party Payer.- 4.3.3 The Perspective of the Health Care Provider.- 4.3.4 The Patient's Perspective.- 4.3.5 Perspective: An Overview.- 4.4 The Alternatives.- 4.4.1 The Research Question: An Overview.- 4.5 Pathways of Clinical Management.- 4.6 Conclusion.- 5 Assessing Costs.- 5.1 Introduction.- 5.2 Types of Costs.- 5.3 Determinants of the Types of Costs To Incorporate into Analysis.- 5.3.1 Type of Analysis.- 5.3.2 Alternatives.- 5.3.3 Perspective.- 5.4 Process of Identifying Costs.- 5.5 Assigning Monetary Values to Resources.- 5.6 Monetary Valuation of Consequences.- 5.7 Specific Types of Costs.- 5.8 Common Problems in Estimating Costs.- 5.9 Conclusion.- 6 Assessing Consequences.- 6.1 Introduction.- 6.2 Types of Consequences.- 6.2.1 Clinical Consequences.- 6.2.2 Psychosocial Consequences.- 6.2.3 Economic Consequences.- 6.3 Determinants of Which Consequences Are Included in an Analysis.- 6.3.1 Type of Study.- 6.3.2 Research Question.- 6.3.3 Perspective.- 6.4 Medication Compliance.- 6.5 Conclusion.- 7 Adjusting Costs and Consequences.- 7.1 Introduction.- 7.2 Discounting.- 7.3 Sensitivity Analysis.- 7.4 Conclusion.- 8 Issues in Study Design.- 8.1 Introduction.- 8.2 Measurement of Consequences.- 8.3 Dimensions of Study Design.- 8.3.1 Prospective Studies.- 8.3.2 Pre-test Post-test Design.- 8.3.3 Quasi-experimental Designs.- 8.3.4 Variations on Prospective Studies.- 8.3.5 Retrospective Studies.- 8.4 Modeling.- 8.5 Conclusion.- 9 How To Assess a Socioeconomic Evaluation.- 9.1 Introduction.- 9.2 Guide for Evaluating Socioeconomic Evaluations.- 9.3 Case Study 1.- 9.4 Case Study 2.- II: Technical Aspects.- 10 Quality of Life Assessment in Socioeconomic Evaluations.- 10.1 Definition of Quality of Life.- 10.2 Importance of Quality of Life Assessment.- 10.3 Measurement of Quality of Life.- 10.4 Conclusion.- 10.5 Examples of Quality of Life Scale Items.- 10.5.1 Social Functioning.- 10.5.2 Physical Functioning.- 10.5.3 Emotional Functioning.- 10.5.4 Intellectual Functioning.- 10.5.5 General Well-being.- Further Reading.- 11 Decision Analysis.- 11.1 Definition of Decision Analysis.- 11.2 Bayes' Theorem.- 11.3 Decision Trees.- 11.4 Sensitivity Analysis.- 11.5 Markov Processes.- 11.6 Conclusion.- Further Reading.- 12 Utility Analysis in Socioeconomic Evaluation.- 12.1 Cost-Utility Analysis and Health State Utilities.- 12.2 Methods for Assessing Health State Utilities.- Further Reading.- 13 Background on Statistics: Fundamental Concepts.- 13.1 Measures of Central Tendency and Dispersion.- 13.2 Hypothesis Testing.- 13.3 Statistical Significance.- 13.4 Type I and Type II Error.- 13.5 Power.- 13.6 Sample Size.- Further Reading.- 14 Basic Analytica Techniques.- 14.1 Levels of Measurement.- 14.2 Parametric and Nonparametric Tests.- 14.3 Commonly Used Statistical Techniques.- 14.3.1 t-Test.- 14.3.2 Analysis of Variance.- 14.3.3 Chi-square Test.- 14.3.4 Correlation Analysis.- 14.3.5 Ordinary Least Squares Regression.- References.- Postscript: Successful Socioeconomic Evaluation of Health Care Services.- Curriculum Vitae of Authors.