Large-scale analysis of interobserver agreement and reliability in cardiotocography interpretation during labor using an online tool.

BACKGROUND: While the effectiveness of cardiotocography in reducing neonatal morbidity is still debated, it remains the primary method for assessing fetal well-being during labor. Evaluating how accurately professionals interpret cardiotocography signals is essential for its effective use. The objective was to evaluate the accuracy of fetal hypoxia prediction by practitioners through the interpretation of cardiotocography signals and clinical variables during labor. MATERIAL AND METHODS: We conducted a cross-sectional online survey, involving 120 obstetric healthcare providers from several countries. One hundred cases, including fifty cases of fetal hypoxia, were randomly assigned to participants who were invited to predict the fetal outcome (binary criterion of pH with a threshold of 7.15) based on the cardiotocography signals and clinical variables. After describing the participants, we calculated (with a 95% confidence interval) the success rate, sensitivity and specificity to predict the fetal outcome for the whole population and according to pH ranges, professional groups and number of years of experience. Interobserver agreement and reliability were evaluated using the proportion of agreement and Cohen's kappa respectively. RESULTS: The overall ability to predict a pH level below 7.15 yielded a success rate of 0.58 (95% CI 0.56-0.60), a sensitivity of 0.58 (95% CI 0.56-0.60) and a specificity of 0.63 (95% CI 0.61-0.65). No significant difference in the success rates was observed with respect to profession and number of years of experience. The success rate was higher for the cases with a pH level below 7.05 (0.69) and above 7.20 (0.66) compared to those falling between 7.05 and 7.20 (0.48). The proportion of agreement between participants was good (0.82), with an overall kappa coefficient indicating substantial reliability (0.63). CONCLUSIONS: The use of an online tool enabled us to collect a large amount of data to analyze how practitioners interpret cardiotocography data during labor. Despite a good level of agreement and reliability among practitioners, the overall accuracy is poor, particularly for cases with a neonatal pH between 7.05 and 7.20. Factors such as profession and experience level do not present notable impact on the accuracy of the annotations. The implementation and use of a computerized cardiotocography analysis software has the potential to enhance the accuracy to detect fetal hypoxia, especially for ambiguous cardiotocography tracings.

Systematic analysis of drug-associated myocarditis reported in the World Health Organization pharmacovigilance database.

While multiple pharmacological drugs have been associated with myocarditis, temporal trends and overall mortality have not been reported. Here we report the spectrum and main features of 5108 reports of drug-induced myocarditis, in a worldwide pharmacovigilance analysis, comprising more than 21 million individual-case-safety reports from 1967 to 2020. Significant association between myocarditis and a suspected drug is assessed using disproportionality analyses, which use Bayesian information component estimates. Overall, we identify 62 drugs associated with myocarditis, 41 of which are categorized into 5 main pharmacological classes: antipsychotics (n = 3108 reports), salicylates (n = 340), antineoplastic-cytotoxics (n = 190), antineoplastic-immunotherapies (n = 538), and vaccines (n = 790). Thirty-eight (61.3%) drugs were not previously reported associated with myocarditis. Antipsychotic was the first (1979) and most reported class (n = 3018). In 2019, the two most reported classes were antipsychotics (54.7%) and immunotherapies (29.5%). Time-to-onset between treatment start and myocarditis is 15 [interquartile range: 10; 23] days. Subsequent mortality is 10.3% and differs between drug classes with immunotherapies the highest, 32.5% and salicylates the lowest, 2.6%. These elements highlight the diversity of presentations of myocarditis depending on drug class, and show the emerging role of antineoplastic drugs in the field of drug-induced myocarditis.