Usefulness of a short-term register for health technology assessment where the evidence base is poor.
ABSTRACT 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.
SourceAvailable from: Marcus Tolentino Silva[Show abstract] [Hide abstract]
ABSTRACT: To evaluate the effectiveness and safety of correction of pectus excavatum by the Nuss technique based on the available scientific evidence. We conducted an evidence synthesis following systematic processes of search, selection, extraction and critical appraisal. Outcomes were classified by importance and had their quality assessed by the Grading of Recommendations Assessment, Development and Evaluation (GRADE). The process of selection of items led to the inclusion of only one systematic review, which synthesized the results of nine observational studies comparing the Nuss and Ravitch procedures. The evidence found was rated as poor and very poor quality. The Nuss procedure has increased the incidence of hemothorax (RR = 5.15; 95% CI: 1.07; 24.89), pneumothorax (RR = 5.26; 95% CI: 1.55; 17.92) and the need for reintervention (RR = 4.88; 95% CI: 2.41; 9.88) when compared to the Ravitch. There was no statistical difference between the two procedures in outcomes: general complications, blood transfusion, hospital stay and time to ambulation. The Nuss operation was faster than the Ravitch (mean difference [MD] = -69.94 minutes, 95% CI: -139.04, -0.83). In the absence of well-designed prospective studies to clarify the evidence, especially in terms of aesthetics and quality of life, surgical indication should be individualized and the choice of the technique based on patient preference and experience of the team.Revista do Colégio Brasileiro de Cirurgiões 11/2014; 41(6):400-5. DOI:10.1590/0100-69912014006004
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ABSTRACT: Objectives: Procedures and new medical devices are typically introduced into healthcare systems with limited evidence, when they might be ineffective or unsafe. Systematic data collection ("registers") can provide valuable "real world" evidence, but difficulties in funding registers are a major obstacle. A good economic case for the value of registers would therefore be useful. Methods: (i) Literature search on specific purposes of registers. (ii) Surveys (a) of senior clinicians involved with registers, seeking examples of beneficial outcomes, and (b) of administrators, regarding costs of running registers. (iii) A scoping exercise for possible methods to value (financially) the outputs of registers. Results: Four main categories of beneficial outcomes from registers were identified. These were-safety and quality assurance; training and quality improvement; complementing trial evidence and reducing uncertainty; and supporting trial research. Explicit examples of all these are presented, together with information about the costs of registers. Combining these with the scoping exercise we present suggestions for a methodology of assessing the value of registers across each of the categories. Conclusions: This study is unique in addressing methods for determining the financial value of registers, based on the amount they cost versus the financial benefits which may result from the evidence generated. Developing the suggested methods could support the case for funding new registers, by showing that their use can benefit healthcare systems through more efficient use of resources, so justifying their costs.International Journal of Technology Assessment in Health Care 01/2014; 30(1):28-33. DOI:10.1017/S0266462313000731 · 1.56 Impact Factor
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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.Cirugía Española 05/2012; 90(5):298–309. DOI:10.1016/j.ciresp.2012.02.010 · 0.89 Impact Factor