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Usefulness of a short-term register for health technology assessment where the evidence base is poor

Published online by Cambridge University Press:  08 January 2010

Hannah Patrick
Affiliation:
National Institute for Health and Clinical Excellence
Sally Gallaugher
Affiliation:
National Institute for Health and Clinical Excellence
Carolyn Czoski-Murray
Affiliation:
School of Health and Related Research University of Sheffield
Robert Wheeler
Affiliation:
Southampton University Hospitals Trust
Marc Chattle
Affiliation:
University of Sheffield
Mirella Marlow
Affiliation:
National Institute for Health and Clinical Excellence
Georgios Lyratzopoulos
Affiliation:
National Institute for Health and Clinical Excellence and University of Cambridge
Bruce Campbell
Affiliation:
National Institute for Health and Clinical Excellence and Universities of Exeter and Plymouth

Abstract

Objectives: This study reviews the coverage and usefulness of a short-term register, established specifically for health technology assessment of a novel interventional procedure (minimally invasive repair of pectus excavatum, or the Nuss procedure).

Methods: Coverage of the register during 2004–07 was assessed by comparison with Hospital Episodes Statistics (HES) for England. Its usefulness was assessed by comparing safety and efficacy data with the published literature and by feedback from committee members who in 2009 were involved in reviewing NICE's original guidance from 2003.

Results: The register reported 260 cases from thirteen UK hospitals during nearly 9 years. During a coverage evaluation period of 3 years, there were 152 registered Nuss procedures. An additional 246 repairs of pectus excavatum were undertaken in twenty-six previously unidentified hospitals. Of the 246, 23 were Nuss procedures (from two hospitals), 140 were open procedures (from eleven hospitals), and 3 were coding errors. No details were available for eighty cases undertaken at ten hospitals. The quantity of published literature had increased substantially since publication of original guidance in 2003. It related mostly to technical and safety outcomes, whereas the register included patient reported outcomes. The literature and the register reported similar rates of major adverse events such as bar displacement (2–10 percent). Committee members considered that the Register made a useful contribution to guidance development.

Conclusions: This study shows that a register set up to support a health technology assessment process can produce useful data both about safety and about patient-reported outcomes. Coverage may be improved by active follow-up based on routine hospital statistics. Improvement in coding for new procedures is needed in the United Kingdom.

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METHODS
Copyright
Copyright © Cambridge University Press 2010

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