Summary

Introduction: The development of a systematic, prioritised process for collecting, analysing, interpreting and disseminating data on new technologies, once these have been introduced into standard clinical practice aims to inform on the implementation, accessibility, acceptability and adequacy of use of new technologies as well as provide valuable and comprehensive information on the costs and investments stemming from their application. Similarly, it enables the detection and assessment of adverse effects or problems of effectiveness which arise when the new technologies are applied under real life use conditions and which are not identified in preliminary studies. The need for a methodological guideline is justified by the fact that currently there is no explicit methodology to guide the observation of health technologies once they have been adopted by the health care system.

Objetives: 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: 1) to develop a prioritisation tool; 2) to identify the most appropriate data-collection instruments for post-introduction observation with their advantages and limitations; and, 3) 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; and 2) 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.

See Results, conclusions, recomendations and english full text abridged version pdf below.