Authors' objectives:

The objectives were to estimate the feasibility, utility and resource implications of electronically captured routine data for health technology assessment by RCTs, and to recommend how routinely collected data could be made more effective for this purpose.

Authors' results and conclusions: The study has shown that some of the research questions posed by health technology assessment through RCTs can indeed be answered using routinely collected data. Where these questions require analysis of NHS resource use, data can usually be identified. Clinical effectiveness can also be judged, using proxy measures for quality of life (QoL), provided clinical symptoms and signs are collected in sufficient detail. Patient and professional preferences cannot be identified from routine data but could be collected routinely by adapting existing instruments. Routine data are potentially cheaper to extract and analyse than designed data. In addition, they facilitate recruitment. They also have the potential to identify patient outcomes captured in remote systems that may be missed in designed data collection. Notwithstanding these potential benefits, the study confirmed previous evidence that the validity of routinely collected data is suspect, particularly in systems that are not under clinical and professional control. There are also potential difficulties in identifying, accessing and extracting data, and in the lack of uniformity in data structures, coding systems and definitions. While data validity remains suspect there is likely to be resistance among researchers to the use of routine data for health technology assessment by RCTs.

Authors' recommendations: Routine data have the potential to support health technology assessment by RCTs. The cost of data collection and analysis is likely to fall, although further work is required to improve the validity of routine data, particularly in central returns. Better knowledge of the capability of local systems and access to the data held on them is also essential. Routinely captured clinical data have real potential to measure patient outcomes, if the data were collected in detail and with precision.

Authors' methods: Randomised controlled trial

Project Status: Completed

URL for project: http://www.hta.ac.uk/957

Year Published: 2003

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

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