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Objectives: The aim of this study was to explore factors that influenced decision making in the assessment of new health technology in Korea.
Methods: We analyzed the decision-making results of the Committee for New Health Technology Assessment (CnHTA) on fifty-three new nondrug health technologies in Korea from July 2007 to December 2010. The scope of the committee was mainly limited to safety and efficacy/effectiveness, and every decision was based on a systematic review of the literature. The committee was composed of healthcare professionals, policy makers, lawyers, and representatives from nongovernmental organizations. Decisions made on therapeutic interventions were included, while those on diagnostic procedures were excluded.
Results: Factors that positively influenced decisions were lower complication rate than existing technology, similar or greater effectiveness compared with existing technology, ability to save critical organs, absence of alternative intervention, decreased invasiveness, expansion of patient's set of choices, and similarity to the mechanism of existing technology. Factors that negatively influenced decisions were higher complication rates than existing technology, lower effectiveness than comparable technology, low levels of evidence, unknown mechanisms of intervention, inconsistency, lack of long-term outcomes, lack of comparative data, nonstandardized technology, heterogeneity between control and treatment, excessively diverse indications, and nongeneralizability.
Conclusions: This qualitative analysis of past decision-making results provided us with clues on the values that decision makers on the Korean CnHTA considered in terms of safety and effectiveness. These findings will help us develop appraisal guidelines and enhance the objectivity of decision-making processes in Korea.
Objectives: Recent concerns have been raised for the safety after drug-eluting stents (DES) implantation compared with the use of bare-metal stents (BMS) in patients with ST-elevation acute myocardial infarction (STEMI). The objective of this study was to estimate the relative impact of DES versus BMS on mortality, myocardial infarction (MI), target vessel revascularization (TVR), and stent thrombosis (ST) in STEMI patients by performing comprehensive meta-analyses of randomized controlled trials (RCTs) and observational studies.
Methods: We performed an electronic search and manual search of studies presented through September 2009, without language restrictions. An approach of “using systematic reviews” was used. Two independent reviewers extracted prespecified data from each study. A random-effects model was used to combine trials and to perform stratified analyses based on study designs and the duration of follow-up.
Results: Fourteen RCTs were identified (N = 7,654). Compared with BMS, DES significantly reduced TVR (risk ratio [RR], 0.48; 95 percent confidence interval [CI], 0.41–0.56) and MI (RR, 0.77; 95 percent CI, 0.61–0.97), without increasing mortality (RR, 0.88; 95 percent CI, 0.70–1.10) and ST (RR, 0.93; 95 percent CI, 0.72–1.21). Among 35 observational studies (N = 44,849), the use of DES was associated with a significant reduction in mortality (RR, 0.85; 95 percent CI, 0.79–0.91) and TVR (RR, 0.61; 95 percent CI, 0.48–0.77). MI and ST were significantly lower in the DES group within 1-year follow-up, but there were no differences within 2 years of follow-up. There was no evidence of statistical heterogeneity and publication bias.
Conclusions: These data in aggregate suggest that using DES in STEMI patients is safe and efficacious, but there are differences between RCT and observational data comparing DES and BMS.
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