Reduced anticoagulation targets in extracorporeal life support (RATE): protocol for a pre-planned secondary Bayesian analysis of the rate trial.

Background: The RATE trial is a three-arm non-inferiority randomized controlled trial in adult patients treated with extracorporeal membrane oxygenation (ECMO) on the effect of anticoagulation levels on mortality, hemorrhagic, and thrombotic complications. The current protocol presents the rationale and analysis plan for evaluating the primary and secondary outcomes under the Bayesian framework.

Methods: This protocol was drafted and submitted before study completion and, thus, the primary analysis.

The prognostic and predictive value of the luminal-like subtype in hormone receptor-positive breast cancer: an analysis of the DATA trial.

Background: This study determines the prognostic value of the luminal-like subtype in patients with hormone receptor-positive breast cancer and explores whether the efficacy of extended anastrozole therapy differs between patients with luminal A-like versus luminal B-like tumours.

Materials And Methods: The phase III DATA study (NCT00301457) examined the efficacy of 6 versus 3 years of anastrozole in postmenopausal women with early-stage hormone receptor-positive breast cancer who had received 2-3 years of tamoxifen. Patients with available formalin-fixed paraffin-embedded tissue blocks were identified and classified by immunohistochemical luminal-like subtype.

Long-term risk of endometrial cancer after assisted reproductive technology.

Study Question: What is the risk of endometrial cancer after long-term follow-up in women treated with ART between 1983 and 2001 compared with women in the general population and subfertile women who did not undergo ART?

Summary Answer: The risk of endometrial cancer is not increased in women who underwent ART in the Netherlands between 1983 and 2001, neither compared with women from the general population nor compared with subfertile women not treated with ART.

What Is Known Already: Concerns have been raised that subfertility treatment may be associated with increased risk of endometrial cancer. However, published studies show inconsistent results regarding the effects of ovarian stimulation and specific subfertility diagnoses on endometrial cancer risk.

Contrast agent dispersion visualized by CE-EUS may be a prediction tool for FOLFIRINOX chemotherapy effectiveness in patients with pancreatic adenocarcinoma.

Background: Pancreatic ductal adenocarcinoma (PDAC) still has a dismal 5-year overall survival of 13 %. Chemotherapy is increasingly used as treatment in both (neo-) adjuvant and palliative conditions. However, the overall survival benefits of chemotherapy must be weighed against significant side effects leading to a reduction in quality of life.

Red blood cell transfusions in neonatal intensive care units: a nationwide observational cohort study.

Objective: To describe the use and nationwide variation of red blood cell (RBC) transfusions in neonatal intensive care units (NICUs) following the introduction of the revised national transfusion guideline in 2019.

Design And Patients: We randomly selected neonates born below 32 weeks' gestation admitted to any NICU in the Netherlands in 2020 to include in our retrospective observational cohort study.

Main Outcome Measures: Main outcome measures were the number of neonates receiving at least one transfusion, and the number of transfusions per transfused neonate.

Optical assessment of scars after endoscopic mucosal resection of large colorectal polyps in a multicenter, community hospital setting: is routine biopsy still necessary?

Background:  Piecemeal endoscopic mucosal resection (EMR) of large (≥ 20 mm) nonpedunculated colorectal polyps (LNPCPs) is succeeded by a 6-month surveillance endoscopy to evaluate the post-EMR scar for recurrence. Data from expert centers suggest that routine tattoo placement and scar biopsies can be omitted, but data from community hospitals are lacking.

Methods:  The agreement between optical assessment and histological confirmation by routine biopsies was evaluated in a post-hoc analysis of the STAR-LNPCP study (NTR7477), containing prospective data on 6-month post-EMR scar assessments in 30 Dutch community hospitals (October 2019 to May 2022).

Evaluation of the recently established Dutch nationwide Archipelago of Ovarian Cancer Research biobank.

Fundamental and translational research in ovarian cancer aims to enhance understanding of disease mechanisms and improve treatment and survival outcomes. To support this, we established the Dutch multicenter, interdisciplinary Archipelago of Ovarian Cancer Research (AOCR) infrastructure, which includes a nationwide biobank. In this study, we share our experiences in establishing the infrastructure, offer guidance for similar initiatives, and evaluate the AOCR patient cohort.

The Need for Standardization of Continuous Glucose Monitoring Performance Evaluation: An Opinion by the International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Continuous Glucose Monitoring.

Metrics derived from continuous glucose monitoring (CGM) systems are often discordant between systems. A major cause is that CGM systems are not standardized; they use various algorithms and calibration methods, leading to discordant CGM readings across systems. This discordance can be addressed by standardizing CGM performance assessments: If manufacturers aim their CGM systems at the same target, then CGM readings will align across systems.

Outcomes of female fertility preservation with cryopreservation of oocytes or embryos in the Netherlands: a population-based study.

Study Question: What are the reproductive outcomes of patients who cryopreserved oocytes or embryos in the context of fertility preservation in the Netherlands?

Summary Answer: This study shows that after a 10-year follow-up period, the utilization rate to attempt pregnancy using cryopreserved oocytes or embryos was 25.5% and the cumulative live birth rate after embryo transfer was 34.6% per patient.

Long-term treatment outcomes of mindfulness-based cognitive therapy for fatigue in patients with inflammatory bowel disease: Results of a randomized controlled trial.

Objectives: Fatigue is prevalent in patients with inflammatory bowel disease (IBD) in remission. Previously, we showed that fatigued IBD patients experienced a significant decrease in fatigue after receiving mindfulness-based cognitive therapy (MBCT). The current study examined to what extent these short-term beneficial effects of MBCT on fatigue were maintained over nine months follow-up, and whether patient characteristics were associated with clinically relevant improvement in fatigue.

The web-based Pleasure&Pregnancy programme in the treatment of unexplained infertility: a randomized controlled trial.

Study Question: Does offering the Pleasure&Pregnancy (P&P) programme rather than expectant management improve naturally conceived ongoing pregnancy rates in couples diagnosed with unexplained infertility?

Summary Answer: The P&P programme had no effect on the ongoing pregnancy rates of couples with unexplained infertility.

What Is Known Already: Underpowered studies suggested that face-to-face interventions targeting sexual health may increase pregnancy rates. The impact of an eHealth sexual health programme had yet to be evaluated by a large randomized controlled trial.

Poor Prognostic Factors in Long-Term Survivors of Resected Pancreatic Ductal Adenocarcinoma: An International, Multicenter Cohort Study.

Objective: To measure the rate of LTS in resected PDAC and determine the association between predictors of OS and LTS.

Summary Background Data: Long-term survival (>5 y, LTS) remains rare in pancreatic ductal adenocarcinoma (PDAC). Multiple predictors of overall survival (OS) are known but their association with LTS remains unclear.

Cumulative live birth rate of a blastocyst versus cleavage stage embryo transfer policy during in vitro fertilisation in women with a good prognosis: multicentre randomised controlled trial.

Objectives: To evaluate whether embryo transfers at blastocyst stage improve the cumulative live birth rate after oocyte retrieval, including both fresh and frozen-thawed transfers, and whether the risk of obstetric and perinatal complications is increased compared with cleavage stage embryo transfers during in vitro fertilisation (IVF) treatment.

Design: Multicentre randomised controlled trial.

Setting: 21 hospitals and clinics in the Netherlands, 18 August 2018 to 17 December 2021.

Diagnostic criteria and long-term outcomes in AIH-PBC variant syndrome under combination therapy.

Background & Aims: Autoimmune hepatitis (AIH) and primary biliary cholangitis (PBC) can co-exist in AIH-PBC, requiring combined treatment with immunosuppression and ursodeoxycholic acid (UDCA). The Paris criteria are commonly used to identify these patients; however, the optimal diagnostic criteria are unknown. We aimed to evaluate the use and clinical relevance of both Paris and Zhang criteria.

Nutritional support in pancreatic cancer patients and its effect on nutritional status: an observational regional HPB network study investigating current practice.

Purpose: Preoperative malnutrition is associated with poor postoperative outcomes in patients with pancreatic cancer. This study evaluated the effectiveness of current practice in nutritional support for patients with pancreatic cancer.

Methods: Observational multicenter HPB network study conducted at the Isala Clinics Zwolle, Medical Spectrum Twente, Medical Center Leeuwarden, and University Medical Center Groningen between October 2021 and May 2023.

Ovarian function recovery in breast cancer patients receiving adjuvant anastrozole treatment: updated results from the phase 3 DATA trial.

Purpose: Patients with chemotherapy-induced ovarian function failure (CIOFF) may experience ovarian function recovery (OFR). Earlier, we showed that OFR during treatment with anastrozole impacted the prognosis of hormone receptor-positive (HR+) breast cancer (BC) patients with CIOFF. Here, we present the long-term follow-up results.

Suboptimal factors in maternal and newborn care for refugees: Lessons learned from perinatal audits in the Netherlands.

Introduction: Refugees and their healthcare providers face numerous challenges in receiving and providing maternal and newborn care. Research exploring how these challenges are related to adverse perinatal and maternal outcomes is scarce. Therefore, this study aims to identify suboptimal factors in maternal and newborn care for asylum-seeking and refugee women and assess to what extent these factors may contribute to adverse pregnancy outcomes in the Netherlands.

Implementation of Pelvic Floor Rehabilitation after rectal cancer surgery: A qualitative study guided by the Consolidated Framework for Implementation Research (CFIR).

Background: Pelvic Floor Rehabilitation (PFR) is effective in a selection of patients with low anterior resection syndrome (LARS) after rectal cancer surgery. This study aimed to identify barriers and enablers to prepare for successful implementation into clinical practice.

Methods: A qualitative study was performed, guided by the Consolidated Framework for Implementation Research (CFIR).

Pelvic Floor Rehabilitation After Rectal Cancer Surgery One-year follow-up of a Multicenter Randomized Clinical Trial (FORCE trial).

Objective: This study aims to evaluate the effects of pelvic floor rehabilitation (PFR) after low anterior resection (LAR) at one-year follow-up.

Summary Background Data: After LAR, with restoration of bowel continuity, up to 90% of patients develop anorectal dysfunction, significantly impacting their quality of life. However, standardized treatment is currently unavailable.