OBJECTIVES:

The principal goal of this guideline is to establish a structured methodological framework for the observation of new technologies after their introduction into clinical practice. The specific goals are:

• to develop a prioritisation tool;
• to identify the most appropriate data-collection instruments for post-introduction observation with their advantages and limitations;
• to establish outcome indicators for assessing the different aspects of post-introduction observation.

METHODS:

The sources of information for this guideline are based on: 1) systematic reviews;

• systematic reviews
• the consensus of experts

The group of experts is made up of professionals coming from the various Spanish Health Technology Assessment (HTA) agencies/units. The final selection and weighting of prioritisation criteria was carried out by a group of panellists representative of medical managers/administrators, clinicians and health service end-users coming from the different Autonomous Regions.

RESULTS:

The guideline consists of 3 results sections. The first section provides the list of finally selected prioritisation criteria (n=14) and describes the tool developed for prioritising health technologies susceptible to post-introduction observation (PriTec.observation tool). 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 be borne in mind when using them for post-introduction observation purposes. The last section of the guideline lays down the basic requirements for implementing a post-introduction observation system, and presents14 specific outcome indicators for assessing the various aspects of post-introduction observation of new technologies.

CONCLUSIONS and RECOMENDATIONS:

• post-introduction observation of new technologies is a strategy which complements the procedures implemented to regulate the incorporation and introduction of new technologies
• this methodological guideline is the first document published on this topic and it might serve as a reference for any institution/body, national or international, which may be planning to and/or are carrying post-introduction observation activities;
• the methodological guideline provides specific procedures and strategies for planning, implementing and evaluating the utilisation of new technologies;
• the methodology of post-introduction observation put forward is a preliminary proposal which will gradually be redefined with the implementation of these systems in different local, national and international settings.
• Application and adaptation of post-introduction observation methodology to different contexts.