RESUMEN
Randomised controlled trials (RCTs) provide clinicians with the best evidence of the effectiveness of an intervention, and complete and transparent trial reports help to critically assess and use trial results. The objective of our study was to assess the quality of reporting in RCTs of sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for heart failure (HF) and identify factors associated with improved reporting quality. Two researchers conducted a comprehensive search in four databases (PubMed, Web of Science, EMBASE, and Cochrane). The quality of each report was assessed using a 25-point Overall Quality Score (OQS) based on the guidelines provided in the 2010 Consolidated Standards for Reporting of Trials (CONSORT) statement. We included a total of 58 relevant RCTs. The median OQS in the 2010 CONSORT statement was 15 (range 7.5-24). The missing items were primarily found in the 'Methods' and 'Results' sections of the 2010 CONSORT statement. Multivariate regression modeling revealed that a more recent publication year, high impact factor, and large sample size were significant predictors of OQS improvement. The findings suggest that the overall quality of reported RCTs of SGLT2 inhibitors in HF is unsatisfactory, which reduces their potential usefulness.
Asunto(s)
Insuficiencia Cardíaca , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Humanos , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Estándares de Referencia , Tamaño de la Muestra , Insuficiencia Cardíaca/tratamiento farmacológicoRESUMEN
BACKGROUND: Randomized controlled trials (RCTs) are subject to bias if they lack methodological quality. Furthermore, optimal and transparent reporting of RCT findings aids their critical appraisal and interpretation. This study aimed to comprehensively evaluate the report quality of RCTs of non-vitamin K oral anticoagulants (NOACs) for the treatment of atrial fibrillation (AF) and to analyze the factors influencing the quality. METHODS: By searching PubMed, Embase, Web of Science, and Cochrane Library databases RCTs published from inception to 2022 evaluating the efficacy of NOACs on AF were collected. By using the 2010 Consolidated Standards for Reporting Tests (CONSORT) statement, the overall quality of each report was assessed. RESULTS: Sixty-two RCTs were retrieved in this study. The median of overall quality score in 2010 was 14 (range: 8.5-20). The extent of compliance with the Consolidated Standards of Reporting Trials reporting guideline differed substantially across items: 9 items were reported adequately (more than 90%), and 3 were reported adequately in less than 10% of trials. Multivariate linear regression analysis showed that the higher reporting scores were associated with higher journal impact factor (P = 0.01), international collaboration (P < 0.01), and Sources of trial funding (P = 0.02). CONCLUSIONS: Although a large number of randomized controlled trials of NOACs for the treatment of AF were published after the CONSORT statement in 2010, the overall quality is still not satisfactory, thus weakening their potential utility and may mislead clinical decisions. This survey provides the first hint for researchers conducting trials of NOACs for AF to improve the quality of reports and to actively apply the CONSORT statement.
Asunto(s)
Fibrilación Atrial , Humanos , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/tratamiento farmacológico , Vitamina K , Ensayos Clínicos Controlados Aleatorios como Asunto , Anticoagulantes/efectos adversos , Administración OralRESUMEN
To include the two key parameters of circulating air volume and instantaneous ultraviolet illuminance, as well as the minor influencing factors such as temperature, humidity, comings and goings of personnel and other parameters into the scope of conventional monitoring, and monitor and alarm each parameter, the key problem is to design the data transmission of sensors of existing products and debug the network management system, and solve every problem in the research process through the cycle of experiment-trial-experiment. The specific functions of a single instrument and system software can be achieved by solving the key links such as type selection of various sensors, circuit interface, guarantee measures for measurement accuracy of various parameters, research and development of networked air disinfection management system software, design of WiFi interface, cost control of single machine and system and so on. And ultraviolet luminance sensors can be used to monitor the ultraviolet intensity in the machine in real time, and monitor 7 parameters, including circulating air volume, ozone concentration, comings and goings of personnel, temperature, humidity and leaked ultraviolet intensity.