[Informed consent process in clinical trials: Insights of researchers, patients and general practitioners]. / Ensayos clínicos y consentimiento informado: visión de investigadores, pacientes y médicos de familia.

OBJECTIVE: Adequate information for patients and respect for their autonomy are mandatory in research. This article examined insights of researchers, patients and general practitioners (GPs) on the informed consent process in clinical trials, and the role of the GP. DESIGN: A cross-sectional study using three questionnaires, informed consent reviews, medical records, and hospital discharge reports. SETTING: GPs, researchers and patients involved in clinical trials. PARTICIPANTS: Included, 504 GPs, 108 researchers, and 71 patients. RESULTS: Consulting the GP was recommended in 50% of the informed consents. Participation in clinical trials was shown in 33% of the medical records and 3% of the hospital discharge reports. GPs scored 3.54 points (on a 1-10 scale) on the assessment of the information received by the principal investigator. The readability of the informed consent sheet was rated 8.03 points by researchers, and the understanding was rated 7.68 points by patients. Patient satisfaction was positively associated with more time for reflection. CONCLUSIONS: GPs were not satisfied with the information received on the participation of patients under their in clinical trials. Researchers were satisfied with the information they offered to patients, and were aware of the need to improve the information GPs received. Patients collaborated greatly towards biomedical research, expressed satisfaction with the overall process, and minimised the difficulties associated with participation.

Sexually transmitted infections, the epidemic that persists after the COVID-19 pandemic: an analysis of the primary care electronic health records covering about 5 million people in Catalonia.

BACKGROUND: The aim of our study is to analyse the trends in the diagnosis of sexually transmitted infections (STIs) during the COVID-19 pandemic. METHODS: We conducted an observational retrospective population-based study using data from primary care electronic health records spanning from January 2016 to December 2022 (involving 5.1 million people older than 14 years). We described the daily number of new STI diagnoses from 2016 to 2022; as well as the monthly accumulation of new STI diagnoses for each year. We compared the monthly averages of new diagnoses in 2019, 2020, 2021 and 2022 using the T-test. Finally, we performed a segmented regression analysis of the daily number of STI diagnoses. RESULTS: We analysed 200,676 new STI diagnoses. The number of diagnoses abruptly decreased coinciding with the lockdown. Overall in 2020, we observed a reduction of 15%, with higher reductions for specific STIs such as gonorrhoea (-21%), chlamydia (-24%), and HIV (-31%) compared to 2019. Following this drastic drop, which was temporarily associated with the lockdown, we observed a rapid rebound. In 2021, the number of STI diagnoses was similar to that of 2019. Notably, we found a considerable increase in 2022, particularly for non-specific STI, which lack laboratory confirmation (67% increase). HIV was the only STI with a reduction of up to -38% in diagnoses at the end of 2022 compared to 2019. CONCLUSIONS: After a significant reduction in 2020, the number of STIs recorded in primary care rapidly rebounded, and the current trend is similar to that of 2019, except for HIV. These findings underscore the dynamic impact of the COVID-19 pandemic on STI diagnoses and highlight the importance of ongoing monitoring and public health interventions in the post-pandemic period.