Article type
Year
Abstract
Background: the objective performance criteria can often be an effective alternative in situations where comparisons cannot be achieved. However, there are different ways to use the objective performance criteria in different studies and currently few methodological studies on objective performance criteria.
Objectives: to explore the characteristics of clinical studies that used objective performance criteria. We hoped to provide more information about it for subsequent clinical researchers.
Methods: we searched PubMed, the Cochrane Library, and Embase for all articles that used objective performance criteria (see figure 1). Two review authors conducted full-text screening and data extraction (MK Yu, M Yang). We extracted relevant information such as the article baseline, the study baseline, the objective performance criteria, the outcome index and its comparison with the objective performance criteria for statistical description.
Results: we included a total of 84 papers. The first article using objective performance criteria was published in 2001; no related articles were detected during the period 2002 to 2009 (see picture 1). Twenty-six articles (26/51, 51.0%) were published in 2017 to 2018, IF = 201.23. From 2001 to 2018, 40 single-arm clinical trials, four retrospective studies, two observational studies, two randomized controlled trials, two diagnostic trials, and one prospective case summary analysis were published. Studies with cardiovascular disease and peripheral vascular disease accounted for 86%(see picture 2), and studies on the effectiveness or safety of medical devices accounted for 76.5% of all. Objective performance criteria were mostly derived from the data of clinical trials of other similar products (29/51, 56.9%), national standards (10/51, 19.6%), and meta-analysis of multiple clinical studies. Twenty-seven articles used hypothesis testing to compare research results with objective performance goal. Twenty-four articles used the confidence interval method.
Conclusions: in existing studies, the objective performance criteria was widely used in many kinds of trials such as in single-arm clinical trials, retrospective, observational studies, randomized controlled trials, and prospective case summaries. More than half of the objective performance criteria were determined by the previous randomized controlled trial. The method of comparison of the final results mainly included two methods: the confidence interval method and the hypothesis test method.
Patient or healthcare consumer involvement: our study can verify that some of the treatments that are not available can be evaluated for safety and efficacy by randomized controlled trials. We hope that our research can provide patients with better and more effective medical services.
Objectives: to explore the characteristics of clinical studies that used objective performance criteria. We hoped to provide more information about it for subsequent clinical researchers.
Methods: we searched PubMed, the Cochrane Library, and Embase for all articles that used objective performance criteria (see figure 1). Two review authors conducted full-text screening and data extraction (MK Yu, M Yang). We extracted relevant information such as the article baseline, the study baseline, the objective performance criteria, the outcome index and its comparison with the objective performance criteria for statistical description.
Results: we included a total of 84 papers. The first article using objective performance criteria was published in 2001; no related articles were detected during the period 2002 to 2009 (see picture 1). Twenty-six articles (26/51, 51.0%) were published in 2017 to 2018, IF = 201.23. From 2001 to 2018, 40 single-arm clinical trials, four retrospective studies, two observational studies, two randomized controlled trials, two diagnostic trials, and one prospective case summary analysis were published. Studies with cardiovascular disease and peripheral vascular disease accounted for 86%(see picture 2), and studies on the effectiveness or safety of medical devices accounted for 76.5% of all. Objective performance criteria were mostly derived from the data of clinical trials of other similar products (29/51, 56.9%), national standards (10/51, 19.6%), and meta-analysis of multiple clinical studies. Twenty-seven articles used hypothesis testing to compare research results with objective performance goal. Twenty-four articles used the confidence interval method.
Conclusions: in existing studies, the objective performance criteria was widely used in many kinds of trials such as in single-arm clinical trials, retrospective, observational studies, randomized controlled trials, and prospective case summaries. More than half of the objective performance criteria were determined by the previous randomized controlled trial. The method of comparison of the final results mainly included two methods: the confidence interval method and the hypothesis test method.
Patient or healthcare consumer involvement: our study can verify that some of the treatments that are not available can be evaluated for safety and efficacy by randomized controlled trials. We hope that our research can provide patients with better and more effective medical services.