HTA 101 INTRODUCTION TO HEALTH TECHNOLOGY ASSESSMENT Clifford S. Goodman, PhD The Lewin Group Falls Church, Virginia, USA [email protected] 2014 Suggested citation: Goodman CS. HTA 101: Introduction to Health Technology Assessment. Bethesda, MD: National Library of Medicine (US); 2014. HTA 101 TABLE OF CONTENTS ACKNOWLEDGMENTS .................................................................................................................................. iv ABOUT THE AUTHOR ..................................................................................................................................... v I. INTRODUCTION ................................................................................................................................... I-1 A. Origins of Technology Assessment .............................................................................................. I-2 B. Early Health Technology Assessment .......................................................................................... I-3 References for Chapter I ..................................................................................................................... I-5 II. FUNDAMENTAL CONCEPTS ................................................................................................................ II-1 A. Health Technology ...................................................................................................................... II-1 B. Health Technology Assessment.................................................................................................. II-3 C. Properties and Impacts Assessed ............................................................................................... II-5 D. Expertise for Conducting HTA .................................................................................................. II-24 E. Basic HTA Frameworks ............................................................................................................. II-25 References for Chapter II ................................................................................................................. II-27 III. PRIMARY DATA METHODS ................................................................................................................ III-1 A. Primary Data Studies: Diverse Attributes .................................................................................. III-1 B. Assessing the Quality of Primary Data Studies ......................................................................... III-4 C. Instruments for Assessing Quality of Individual Studies ......................................................... III-14 D. Strengths and Limitations of RCTs........................................................................................... III-14 E. Different Study Designs for Different Questions .................................................................... III-21 F. Complementary Methods for Internal and External Validity .................................................. III-23 G. Evidence Hierarchies ............................................................................................................... III-24 H. Alternative and Emerging Study Designs Relevant to HTA ..................................................... III-27 I. Collecting New Primary Data .................................................................................................. III-30 References for Chapter III ............................................................................................................... III-32 HTA 101 i IV. INTEGRATIVE METHODS ................................................................................................................... IV-1 A. Systematic Literature Reviews .................................................................................................. IV-2 B. Working with Best Evidence ...................................................................................................... IV-7 C. Meta-Analysis ............................................................................................................................ IV-8 D. Guidelines for Reporting Primary and Secondary Research ................................................... IV-11 E. Modeling ................................................................................................................................. IV-12 F. Assessing the Quality of a Body of Evidence ........................................................................... IV-16 G. Consensus Development ......................................................................................................... IV-21 References for Chapter IV ............................................................................................................... IV-23 V. ECONOMIC ANALYSIS METHODS ....................................................................................................... V-1 A. Main Types of Economic Analysis in HTA ................................................................................... V-1 B. Key Attributes of Cost Analyses ................................................................................................. V-3 C. Cost-Effectiveness Plane ............................................................................................................ V-8 D. Cost-Utility Analysis Using Cost per QALY ................................................................................ V-10 E. Role of Budget Impact Analysis ................................................................................................ V-14 F. Collecting Cost Data in Clinical Studies .................................................................................... V-15 References for Chapter V ................................................................................................................. V-16 VI. DETERMINE TOPICS ........................................................................................................................... VI-1 A. Identify Candidate Topics .......................................................................................................... VI-1 B. Setting Assessment Priorities .................................................................................................... VI-4 C. Specify the Assessment Problem .............................................................................................. VI-7 D. Reassessment and the Moving Target Problem...................................................................... VI-10 References for Chapter VI ............................................................................................................... VI-13 VII. RETRIEVE EVIDENCE ......................................................................................................................... VII-1 A. Types of Sources ....................................................................................................................... VII-1 B. Grey Literature ......................................................................................................................... VII-5 C. Publication Bias ........................................................................................................................ VII-6 D. Help for Searchers .................................................................................................................... VII-7 References for Chapter VII ............................................................................................................... VII-9 HTA 101 ii VIII. DISSEMINATE FINDINGS AND RECOMMENDATIONS ..................................................................... VIII-1 A. Competing for Attention ......................................................................................................... VIII-1 B. Basic Dissemination Framework ............................................................................................. VIII-3 C. Dissemination Plan .................................................................................................................. VIII-5 D. Managing Access ..................................................................................................................... VIII-5 References for Chapter VIII ............................................................................................................. VIII-6 IX. MONITOR IMPACT OF HTA ............................................................................................................... IX-1 A. Attributing Impact to HTA Reports ........................................................................................... IX-2 B. Factors Influencing Impact ........................................................................................................ IX-3 References for Chapter IX ................................................................................................................. IX-5 X. SELECTED ISSUES IN HTA .................................................................................................................... X-1 A. Barriers to HTA ........................................................................................................................... X-1 B. Quality of Care and HTA ............................................................................................................. X-3 C. Comparative Effectiveness Research and HTA ..........................................................................