a1 National Institute for Health and Clinical Excellence
a2 School of Health and Related Research University of Sheffield
a3 Southampton University Hospitals Trust
a4 University of Sheffield
a5 National Institute for Health and Clinical Excellence
a6 National Institute for Health and Clinical Excellence and University of Cambridge
a7 National Institute for Health and Clinical Excellence and Universities of Exeter and Plymouth
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.
We thank all those who contributed information to the register and took part in the register validation exercise. In particular, we are grateful to Mr. Roger Franks and Ms. Lynda Beggs for their contribution to the development of the dataset as well as Dr. Craig Ramsay and Laura Bruton for statistical advice and support in requesting information from hospitals.
The authors have not received any funding from external sources for the conduct of this study.
Conflict of interest — none of the authors have any conflict of interest to declare. One of the authors (R.W.) is a clinician who carries out this procedure in the NHS.