Article type
Abstract
Background: New health technologies should be evaluated based on robust evidence related to relevant criteria, such as effectiveness, safety, and costs, before being implemented in clinical practice. Frameworks guiding this evaluation process from evidence to recommendation play a key role in healthcare decision-making. Currently, guidance on how to develop such frameworks is lacking.
Objective: This paper aims to provide guidance for developing or adapting frameworks for evaluating health technologies.
Methods: We reviewed multiple existing evaluation frameworks, described methodologies used for developing these, and compared their features. Based on an analysis of these existing frameworks and our experience with developing and using multiple frameworks, we provide guidance outlining key steps of framework development, along with examples of best practice.
Results: Our guidance consists of two sections: development of the evaluation framework itself, and dissemination and implementation of the newly developed framework. Five steps were considered important in developing a framework: 1) identify need to develop a new framework; 2) define scope and goal of framework; 3) develop evaluation criteria; 4) develop guidance on formulating recommendations; and 5) pilot and refine the framework. We also present methodological tools on how to systematically arrive at relevant domains, evaluation criteria, operationalization of criteria, type of recommendations, and translation of all collected evidence to recommendations. Moreover, we describe the timing of piloting and revising, and methods for dissemination.
Conclusion: This guidance provides researchers aiming to develop a framework for assessment of health technologies with practical steps and tools. The use of this guidance may facilitate a systematic approach towards framework development, to aid transparent decision-making. No one-size-fits-all methodology exists for developing an evaluation framework; we facilitate tailoring this approach to context specific needs.
Relevance and importance to patients: A systematic and transparent evaluation of health technologies is essential to enhance the trust of patients and the public in regulatory processes.
Objective: This paper aims to provide guidance for developing or adapting frameworks for evaluating health technologies.
Methods: We reviewed multiple existing evaluation frameworks, described methodologies used for developing these, and compared their features. Based on an analysis of these existing frameworks and our experience with developing and using multiple frameworks, we provide guidance outlining key steps of framework development, along with examples of best practice.
Results: Our guidance consists of two sections: development of the evaluation framework itself, and dissemination and implementation of the newly developed framework. Five steps were considered important in developing a framework: 1) identify need to develop a new framework; 2) define scope and goal of framework; 3) develop evaluation criteria; 4) develop guidance on formulating recommendations; and 5) pilot and refine the framework. We also present methodological tools on how to systematically arrive at relevant domains, evaluation criteria, operationalization of criteria, type of recommendations, and translation of all collected evidence to recommendations. Moreover, we describe the timing of piloting and revising, and methods for dissemination.
Conclusion: This guidance provides researchers aiming to develop a framework for assessment of health technologies with practical steps and tools. The use of this guidance may facilitate a systematic approach towards framework development, to aid transparent decision-making. No one-size-fits-all methodology exists for developing an evaluation framework; we facilitate tailoring this approach to context specific needs.
Relevance and importance to patients: A systematic and transparent evaluation of health technologies is essential to enhance the trust of patients and the public in regulatory processes.