Post-Introduction Observation of Health Technologies. A Methodological Guideline

Aim: To establish a structured methodological framework to observe new technologies after their introduction into clinical practice.

Conclusions and results: The specific goals are: 1) to develop a prioritization tool; 2) to identify the most appropriate data-collection instruments for post-introduction observation and their advantages and limitations; and 3) to establish outcome indicators for assessing the different aspects of post-introduction observation.

Post-introduction observation of new technologies is a strategy to complement the procedures implemented to regulate the incorporation and introduction of new technologies. This methodological guideline is the first document published on the topic and could serve as a reference for any national or international body in planning and/or implementing post-introduction observation activities. It provides specific procedures and strategies to plan, implement, and evaluate the utilization of new technologies. The guideline consists of 3 sections. The first section provides the final list of selected prioritization criteria (n=14) and describes the tool developed for prioritizing health technologies susceptible to post-introduction observation. The second section describes and assesses 4 instruments that could be used for data collection, along with an outline of the advantages, drawbacks, and considerations to remember when using them for post-introduction observation purposes. The third section of the guideline lays down the basic requirements for implementing a post-introduction observation system. It also presents 14 specific outcome indicators for assessing the various aspects of post-introduction observation of new technologies.

Recommendations: Apply and adapt post-introduction observation methodology to different contexts.

Methods: The information sources for this guideline are based on systematic reviews and the consensus of experts. The group of experts is comprised of professionals from the various Spanish health technology assessment (HTA) agencies/units. A group of panelists representative of medical managers/administrators, clinicians, and end-users of health services from the different autonomous regions carried out the final selection and weighting of prioritization criteria.

Written by: Leonor Varela Lema, AVALIA-T, Spain