The ESSAG-trial protocol: A randomized controlled trial evaluating the efficacy of offering a self-sampling kit by the GP to reach women underscreened in the routine cervical cancer screening program.

BACKGROUND: In Flanders (Belgium), women not screened for cervical cancer (CC) within the last three years receive an invitation letter from the regional screening organization, the Centre for Cancer Detection (CCD), encouraging them to have a cervical specimen taken by their general practitioner (GP) or gynecologist. However, the coverage for CC screening remains suboptimal (63%). The offer of a self-sampling kit (SSK, for HPV testing) by a GP may trigger participation among women who do not attend regular screening. METHODS: The ESSAG-trial is a cluster-randomized controlled trial with three arms, each including 1125 women aged 31-64 years, who were not screened for CC in the last 6 years. In arm A, GPs offer a SSK when eligible women consult for any reason. In arm B, women receive a personal GP signed invitation letter including an SSK at their home address. In the control arm, women receive the standard invitation letter from the CCD. The primary outcome is the response rate at three months after inclusion. Secondary outcomes are: screen test positivity; compliance with foreseen follow-up among screen-positives; costs per invited and per screened women; as well as contrasts between trial arms and between socio-demographic categories. CONCLUSION: The ESSAG-trial will assess the effect of GP-based interventions using SSKs on CC screening participation among hard-to-reach populations. Findings will inform policymakers about feasible strategies on increasing CC screening that may be rolled-out throughout the whole region. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05656976.

The impact of the Covid-19 pandemic on the incidence of diseases and the provision of primary care: A registry-based study.

INTRODUCTION: The Covid-19 pandemic had a tremendous impact on healthcare but uncertainty remains about the extent to which primary care provision was affected. Therefore, this paper aims to assess the impact on primary care provision and the evolution of the incidence of disease during the first year of the Covid-19 pandemic in Flanders (Belgium). METHODS: Care provision was defined as the number of new entries added to a patient's medical history. Pre-pandemic care provision (February 1, 2018-January 31, 2020) was compared with care provision during the pandemic (February 1, 2020-January 31, 2021). A large morbidity registry (Intego) was used. Regression models compared the effect of demographic characteristics on care provision and on acute and chronic diagnoses incidence both prior and during the pandemic. RESULTS: During the first year of the Covid-19 pandemic, overall care provision increased with 9.1% (95%CI 8.5%;9.6%). There was an increase in acute diagnoses of 5.1% (95%CI 4.2%;6.0%) and a decrease in the selected chronic diagnoses of 12.8% (95% CI 7.0%;18.4%). Obesity was an exception with an overall incidence increase. The pandemic led to strong fluctuations in care provision that were not the same for all types of care and all demographic groups in Flanders. Relative to other groups in the population, the pandemic caused a reduction in care provision for children aged 0-17 year and patients from a lower socio-economic situation. CONCLUSION: This paper strengthened the claim that Covid-19 should be considered as a syndemic instead of a pandemic. During the first Covid-19 year, overall care provision and the incidence of acute diagnoses increased, whereas chronic diseases' incidence decreased, except for obesity diagnoses which increased. More granular, care provision and chronic diseases' incidence decreased during the lockdowns, especially for people with a lower socio-economic status. After the lockdowns they both returned to baseline.

The effect of automated audit and feedback on data completeness in the electronic health record of the general physician: protocol for a cluster randomized controlled trial.

BACKGROUND: The electronic health record (EHR) of the general physician (GP) is an important tool that can be used to assess and improve the quality of healthcare. However, there are some problems when (re) using the data gathered in the EHR for quality assessments. One problem is the lack of data completeness in the EHR. Audit and feedback (A&F) is a well-known quality intervention that can improve the quality of healthcare. We hypothesize that an automated A&F intervention can be adapted to improve the data completeness of the EHR of the GP, more specifically, the number of correctly registered diagnoses of type 2 diabetes and chronic kidney disease. METHODS: This study is a pragmatic cluster randomized controlled trial with an intervention at the level of GP practice. The intervention consists of an audit and extended electronically delivered feedback with multiple components that will be delivered 4 times electronically to general practices over 12 months. The data will be analyzed on an aggregated level (per GP practice). The primary outcome is the percentage of correctly registered diagnoses of type 2 diabetes. The key secondary outcome is the registration of chronic kidney disease. Exploratory secondary outcomes are the registration of heart failure, biometric data and lifestyle habits, and the evolution of 4 different EHR-extractable quality indicators. DISCUSSION: This cluster randomized controlled trial intends to primarily improve the registration of type 2 diabetes in the EHR of the GP and to secondarily improve the registration of chronic kidney disease. In addition, the registration of heart failure, lifestyle parameters, and biometric data in the EHR of the GP are explored together with 4 EHR-extractable quality indicators. By doing so, this study aims to improve the data completeness of the EHR, paving the way for future quality assessments. TRIAL REGISTRATION: ClinicalTrials.gov NCT04388228 . Registered on May 14, 2020.