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Predicting outcomes in selective fetal growth restriction of monoChOrioNic Twins: an inteRnAtional observational cohort STudy protocol (CONTRAST study)

Por: Noll · A. · Javinani · A. · Slaghekke · F. · Haak · M. C. · van Klink · J. · Van der Meeren · L. · Lopriore · E. · Russo · F. · Aertsen · M. · Shamshirsaz · A. · Shinar · S. · Bennasar · M. · Tiblad · E. · Herling · L. · Lewi · L. · Verweij · E. · CONTRAST Study Group · Keizer · Steggerd
Introduction

Selective fetal growth restriction (sFGR) is a major cause of perinatal morbidity and mortality in monochorionic diamniotic (MCDA) twin pregnancies. Current management relies on umbilical artery Doppler patterns in the smaller twin. These patterns are, however, inconsistent and do not represent a reliable severity scale, complicating clinical decision-making and parental counselling. This study aims to improve risk stratification by identifying predictors of adverse outcomes, while also evaluating the pathophysiology and multi-organ impact of sFGR in early childhood.

Methods and analysis

This is a prospective, international, multicentre cohort study conducted in six tertiary fetal medicine centres with expertise in complicated twin pregnancies. Recruitment began in March 2023 and will continue until December 2026, targeting 274 MCDA twin pairs with complete follow-up to develop a prediction model for adverse perinatal outcomes in sFGR at the time of diagnosis. Standardised data collection includes serial ultrasound examinations, advanced fetal imaging (cardiac, cerebral and 3D volumetric), fetal brain MRI and detailed placental phenotyping. Maternal and parental well-being are assessed during pregnancy and after birth. Neurodevelopmental outcome is evaluated up to 2 years after birth using validated tools. The statistical analysis plan includes predictive modelling with internal validation.

Ethics and dissemination

The study has been approved by the ethical review boards of all participating centres. Findings will be disseminated through peer-reviewed publications, international conferences and engagement with clinical guideline committees.

Trial registration number

NCT05952583.

Unwarranted variation in potentially inappropriate medication in general practice: a Danish nationwide register-based cohort study

Por: Paust · A. · Vestergaard · C. H. · Gronkjaer Laugesen · I. · Bro · F. · Mygind · A. · Utoft · N. B. · Prior · A.
Objectives

To examine how the population composition, practice organisation and geographical context of general practice clinics are associated with unwarranted variation in prescribing patterns (variation not explained by patient characteristics), using potentially inappropriate medication (PIM) as an indicator of treatment quality.

Design

A nationwide register-based cohort study.

Setting and population

Data on eligible general practice clinics (1703 clinics) in Denmark and their listed patient populations (4 369 915 individuals) were collected from 1 January to 31 December 2021.

Main outcome measures

Unwarranted variation in PIM was estimated using the clinics’ PIM propensity. PIM propensity in clinics was defined as the ratio between observed and expected PIM incidence among listed patients and was stratified into indicators of underprescribing and overprescribing.

Results

The results demonstrate a 13% difference in PIM propensity between clinics with the highest propensity (90th percentile) and the lowest propensity (10th percentile). When stratifying by underprescribing and overprescribing, we found a relative difference of 12% for underprescribing and 50% for overprescribing between the two groups. Clinics serving male-dominated populations (>55% men 1.11, 95% CI 1.08 to 1.14) and more socially deprived patient populations (deprivation index >40 10.11, 95% CI 1.08 to 1.14) had a higher propensity for overprescribing. Organisational factors associated with overprescribing included single-handed practices (1.08, 95% CI 1.06 to 1.10), smaller patient lists (100 000 citizens: 1.04, 95% CI 1.02 to 1.07). In contrast, disease burden and age distribution in listed patients appeared to have no clinically relevant association with PIM propensity.

Conclusions

This study indicates unwarranted variation in the medical treatment quality, primarily related to overprescribing. Inferior treatment quality was associated with patient composition, practice organisation and geographical context. This emphasises a need for new strategies to address the inverse care law and enhance patient safety.

Methods and baseline results of the Cohort of Health-Related Outcomes in Chronic Illness Care in General Practice in Denmark (CHRONIC-GP)

Por: Larsen · H. H. · Willadsen · T. G. · Prior · A. · Lyhnebeck · A. B. · Waldorff · F. B. · Holm · A.
Purpose

The Cohort of Health-Related Outcomes in Chronic Illness Care in General Practice was established using data collected as part of a cluster-randomised trial. This aims to support the trial’s follow-up and enable further examination of the interplay between chronic disease, multimorbidity (MM), polypharmacy (PP) and quality of life (QoL) in a Danish general practice setting.

Participants

The cohort comprises 35 977 adult patients from 250 general practices participating in a cluster-randomised trial and had a response rate of 22.4%. Participants were either registered as chronic care patients or had attended an annual chronic disease consultation. They completed a comprehensive questionnaire on self-reported chronic conditions, medication use, QoL, treatment burden and patient-centred care. Additionally, 431 general practitioners (GPs) from the participating practices completed a questionnaire about managing patients with complex MM.

Findings to date

Among participants, 51.9% were female, the mean age was 65.6 (SD 12.9) years, 93.1% had education beyond basic schooling, and half were retired. Conditions from more than one organ system-based disease group were reported by 82.2%, and 94.6% used one or more prescription medications. The main challenges reported by the participating GPs in managing patients with complex MM were keeping time and obtaining an overview of the patient’s health status.

Future plans

Cohort data will be linked with Danish registries to improve the detection and treatment of chronic conditions and PP in general practice.

Registration

The cluster randomised trial (MM600) is registered with ClinicalTrials.gov ID: NCT05676541.

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