Usefulness of a short-term register for health technology assessment where the evidence base is poor
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).
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.
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.
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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ABSTRACT: This review is trying to address the effectiveness and sustainability of results following minimally invasive repair of pectus excavatum (MIRPE). The aim is to present these results for the benefit of clinicians and the patients. Literature search has revealed 179 hits, which were independently assessed and led to 80 publications being formally reviewed. Studies reporting results from less than 10 patients were excluded. Thirty-five studies were found to be reporting results from patients' and/or surgeons' perspective and they were included in this review. Data from the United Kingdom registry for MIRPE were also included. Results from over 2997 patients (age: <1-85 years) who had MIRPE and 1393 patients who had their metallic bar removed were assessed. The most common indication for surgery was cosmesis. There was a net gain with regard to self-esteem for 96-100% of the individuals. A percentage of procedures (0-20%) was assessed by surgeons as having an 'unsatisfactory outcome' and a number of patients (0-25%) reported an 'unsatisfactory end result.' However, these percentages are not necessarily referring to the same patients and an unsatisfactory result does not seem to affect the positive effect on self-esteem. The reported changes in social life, lung capacity, cardiovascular capacity, exercise capacity and general health are based on weak data and significant improvements, if any, are probably seen in a limited number of patients. The metallic bars were removed after 1.5-4.5 years and there is an overall 0-4.5% reported recurrence post-bar removal. In conclusion, MIRPE may improve cosmesis and self-esteem of patients with pectus excavatum deformity. Direct or indirect improvement in other physiological parameters may also help the 'well-being' of these patients and their social integration. There is a clear need for standardisation in the way results are reported in the literature and a socioeconomic analysis with regard to gains, benefits and costs related to MIRPE.
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ABSTRACT: IntroductionLaparoscopic surgery through a single incision is an innovative concept which is a challenge for surgeons to implement and develop.The interest aroused by these techniques in Spain led to the Endoscopy Section of the Spanish Association of Surgeons (AEC) to start a National Register for Single-Incision Surgery (RNCIU).The aim of this study was to collect the primary clinical data, techniques, and the possible complications of these techniques in Spain.Material and methodsData were gathered using a form available on the AEC website. The forms included in this study correspond to those received between June 2010 and June 2011.ResultsA total of 35 centers had taken part during the study period, with1,198 forms being collected. The surgeries performed included 62.2% cholecystectomies, 22% appendectomies, and 7.8% colectomies. Procedures on solid organs (3.4%), bariatric surgery (2.7%), and various hernia repairs (1.9%), were also registered.The overall incidence of complications was 0.8%. The mortality rate in the series was 0.1%.Conclusions
Single incision laparoscopic surgery is a novel concept that is not beyond our scientific community. The results of the Register demonstrate the feasibility of numerous effective and safe procedures. Finally, the RNCIU is an important data source to be able to study sub-groups of diseases in detail, with the aim of advancing the knowledge of these techniques and generating scientific evidence.
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