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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 ,
Sally Gallaugher ,
Carolyn Czoski-Murray ,
Robert Wheeler ,
Marc Chattle ,
Mirella Marlow ,
Georgios Lyratzopoulos  and
Bruce Campbell
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
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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.

Keywords

RegistersHealthcare technology assessment
Type
METHODS
Information
International Journal of Technology Assessment in Health Care , Volume 26 , Issue 1 , January 2010 , pp. 95 - 101
Copyright
Copyright © Cambridge University Press 2010

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References

REFERENCES

1. Aylin, P, Lees, T, Baker, S, et al. Descriptive study comparing routine hospital administrative data with the vascular society of Great Britain and Ireland's national vascular database. Eur J Vasc Endovasc Surg. 2007;33:461–465.CrossRefGoogle ScholarPubMed
2. Bravata, DM, McDonald, KM, Gienger, AL, et al. Comparative effectiveness of percutaneous coronary interventions and coronary artery bypass grafting for coronary artery disease [Comparative Effectiveness Review No. 9, October 2007]. Agency for Healthcare Research and Quality. http://healthcare.ahrq.gov/repFiles/CER_PCI_CABGMainReport.pdf (accessed July 6, 2009).Google Scholar
3. Britton, A, McKee, M, Black, N, et al. Choosing between randomised and non-randomised studies a systematic review. Health Technol Assess. 1998;2:13.CrossRefGoogle ScholarPubMed
4. Davis, JT, Weinstein, S. Repair of the pectus deformity: Results of the Ravitch approach in the current era. Ann Thorac Surg. 2004;78:421–426.CrossRefGoogle ScholarPubMed
5. Dreyer, N, Garner, S. Registries for robust evidence. JAMA. 2009;302:790–791.CrossRefGoogle ScholarPubMed
6. Gibbs, J, Monro, J, Cunningham, D, et al. Survival after surgery or therapeutic catheterisation for congenital heart disease in children in the United Kingdom: Analysis of the central cardiac audit database for 2000–1. BMJ. 2004;328:611.CrossRefGoogle ScholarPubMed
7. Gips, H, Zaitsev, K, Hiss, J. Cardiac perforation by a pectus bar after surgical correction of pectus excavatum: Case report and review of the literature. Pediatr Surg Int. 2008;24:617–620.CrossRefGoogle ScholarPubMed
8. Glasziou, P, Chalmers, I, Rawlins, M, McCulloch, P. When are randomised trials unnecessary? Picking signal from noise. BMJ. 2007;334:349–351.CrossRefGoogle ScholarPubMed
9. Hosie, S, Sitkiewicz, T, Petersen, C, et al. Minimally invasive repair of pectus excavatum–the Nuss procedure. A European multicentre experience. Eur J Pediatr Surg. 2002;12:235–238.CrossRefGoogle ScholarPubMed
10. Lyratzopoulos, G, Patrick, H, Campbell, B. Registers needed for interventional procedures. Lancet. 2008;371:1734–1736.CrossRefGoogle ScholarPubMed
11. Malley, S, Selby, W, Jordan, E. A successful practical application of coverage with evidence development in Australia: Medical Services Advisory Committee interim funding and the PillCam® Capsule Endoscopy Register. Int J Technol Assess Health Care. 2009;25:290–296.CrossRefGoogle Scholar
12. National Institute for Health and Clinical Excellence. Minimally invasive placement of pectus bar. Procedure guidance. 2005. http://www.nice.org.uk/guidance/index.jsp?action=download&o=30963 (accessed March 2009).Google Scholar
13. National Institute for Health and Clinical Excellence. Interventional procedures process manual. http://www.nice.org.uk/aboutnice/howwework/developingniceinterventionalprocedures/interventionalproceduresprogrammemanual/interventionalprocedures_programme_manual.jsp?domedia=1&mid=70C7F0D8–19B9-E0B5-D464C50580F580B1 (accessed June 2009).Google Scholar
14. NHS Connecting for Health. OPCS-4 intervention classification. 2009. http://www.connectingforhealth.nhs.uk/systemsandservices/data/clinicalcoding/codingstandards/opcs4. Accessed March 2009.Google Scholar
15. Newton, J, Garner, S. Disease registers in England. A report commissioned by the Department of Health Policy Research Programme in support of the White Paper entitled: Saving lives: Our healthier nation. London: Department of Health; 2001.Google Scholar
16. Newton, J. Evaluating health care using routine data. Chapter 5.2. Oxford handbook of public health practice. Oxford: Oxford University Press; 2001.Google Scholar
17. Nuss, D. Recent experiences with minimally invasive pectus excavatum repair “Nuss Procedure”. Jpn J Thorac Cardiovasc Surg. 2005;53:338–344.CrossRefGoogle ScholarPubMed
18. Park, HJ, Lee, SY, Lee, CS, et al. The Nuss procedure for pectus excavatum: Evolution of techniques and early results on 322 patients. Ann Thorac Surg. 2004;77:289–295.CrossRefGoogle ScholarPubMed
19. Potts, M, Prata, N, Walsh, J, Grossman, A. Parachute approach to evidence based medicine. BMJ. 2006;333:701–703.CrossRefGoogle ScholarPubMed
20. Powell, J, Buchan, I. Electronic health records should support clinical research. J Med Internet Res. 2005;7:e4.CrossRefGoogle ScholarPubMed
21. Sibanda, N, Copley, L, Lewsey, J, et al. Revision rates after primary hip and knee replacement in England 2003–2006. PLoS Med. 2008;5:e179.CrossRefGoogle Scholar
22. Tilson, HH, Doi, PA, Covington, DL, et al. The antiretrovirals in pregnancy registry: A fifteenth anniversary celebration. Obstet Gynecol Surv. 2007;62:137–148.CrossRefGoogle ScholarPubMed
23. Tunis, S, Chalkidou, K. Coverage with evidence development: A very good beginning, but much to be done. Commentary to Hutton et al. Int J Technol Assess Health Care. 2007;23:4.CrossRefGoogle Scholar
24. Wilson, EB. J Am Stat Assoc. 1927;22:209–212. Statistical web site. http://www.cardiff.ac.uk/medic/aboutus/departments/primarycareandpublichealth/ourresearch/resources/index.html (accessed September 2009).CrossRefGoogle Scholar