Deventer Ziekenhuis

Background/Objectives: Decreased preoperative mobility increases the risk of decline and postoperative mortality in a frail patient with a hip fracture. This study investigates the correlation between preoperative mobility and 1-year mortality and between pre- and postoperative mobility. Methods: This retrospective, national cohort study used data from the Dutch Hip Fracture Audit (2018-2023). Excluded patients were those with an indication for a total hip arthroplasty, non-surgical treatment or missing data on mortality or preoperative mobility. Mobility was determined by the Fracture Mobility Score (FMS). A Cox proportional-hazards regression model assessed the correlation between FMS and mortality by using hazard ratios with 95% confidence intervals. A subgroup analysis was conducted for patients whose data on postoperative mobility was complete. Spearman's test was used to assess the correlation between pre- and postoperative mobility. A p-value < 0.05 was considered statistically significant in both analyses. Results: A total of 77,185 patients were included in the study. A Cox regression model shows a stepwise increase in risk of death with a lower preoperative FMS, after correction of confounders. Those with no functional mobility showed the highest risk of death within 1 year after surgery (HR 1.86, 95% CI 1.65-2.09, p < 0.001). Spearman's correlation demonstrated a moderate positive correlation between pre- and postoperative mobility, which is demonstrated by ρ = 0.49 (p < 0.001). Conclusions: Preoperative mobility seems to be an independent predictor of 1-year mortality. Additionally, this study demonstrated a moderate positive correlation between pre- and postoperative mobility.

Abstract Background: In early-stage breast cancer, surgical de-escalation from axillary lymph node dissection (ALND) to sentinel lymph node biopsy (SLNB) did not compromise oncologic safety. This has led to the realization that SLNB predominantly provides prognostic information and may itself not influence recurrence or survival. The BOOG 2013-08 trial was therefore designed to evaluate whether omission of SLNB in clinically T1-2N0 patients treated with breast-conserving surgery and whole-breast irradiation (summarized together as BCT) is safe with respect to regional recurrence rates (RR) and distant disease-free survival (DDFS). Methods: The BOOG 2013-08 (NCT02271828) is a multicenter, non-inferiority, randomized phase-3 trial including women with unilateral cT1-2N0 breast cancer treated with BCT. Clinically node-negative was based on negative findings on physical examination and preoperative axillary ultrasound (including negative cyto- or histopathology in case of a suspicious findings). The trial was conducted in the Netherlands between 2015 and 2022 across 25 centers. Patients were randomized (1:1) to SLNB or omission of SLNB. Randomization was stratified by clinical tumor size (&amp;lt;3 cm vs ≥3 cm), histological grade (grade I-II vs III), hormone receptor status (HR), HER2 status, age (≤50, 50 ≤ 75, &amp;gt;75 years), primary systemic therapy (PST) and participating center. The primary endpoint was 5-year RR; secondary endpoints as presented here were 3-year RR and DDFS. Cumulative probabilities of RR and DDFS were estimated using the Kaplan-Meier method. Non-inferiority was defined as an absolute difference in RR ≤5% in favor of the control group at 5 years. Analyses were performed per-protocol. Results: A total of 1,733 patients were enrolled across 25 centers. After excluding 159 patients (n=106 due to radiation therapy protocol violations), 1574 patients were included (SLNB: n=749; no-SLNB: n=825). At the time of analysis, 100% of patients had reached 3 years and 73% 5-year follow-up. Median follow-up was 5.0 years (range 0.78-6.86, IQR 1.94). Mean age was 61.5 years, 83% had cT1 tumors and 17% cT2 tumors. Tumor grade was I in 28.7%, II in 54.1% and III in 17.2%. Breast cancer subtype was HR+HER2- in 86.8%, triple negative in 5.8% and HER2+ in 7.4% of patients. In the SLNB arm, micro- and macrometastatic disease was detected in 6.0% and 7.7%, respectively. Preliminary data at a median 5-year follow-up showed that the estimated probability of RR was 0.5% in the SLNB arm (95% CI 0.0-1.1) and 1.2% in the no-SLNB arm (95% CI 0.4-2.0), corresponding to an absolute difference of 0.7% (95% CI -0.3 to 1.7). The confidence interval ranges from -0.3 to 0.7, indicating that the 5% non-inferiority margin is not exceeded. Five-year DDFS was 98.3% (95% CI 97.3-99.3) in the SLNB arm versus 96.1% (95% CI 94.5-97.7) in the no-SLNB arm (log-rank p=0.071).Chemo- or endocrine therapy was administered in 11.3% of patients as PST (12.3% SLNB arm vs. 10.3 no-SLNB arm, p=0.214). In total, 50.0% of patients received systemic therapy (51.2% SLNB vs. 49.0% no-SLNB, p 0.202). Of these 50.0%, 39.4% received chemotherapy with or without targeted therapy. Among ER-positive patients, adjuvant endocrine therapy was administered in 48.6% (SLNB) and 46.6% (no-SLNB), p=0.732, while chemotherapy was given in 9.8% and 8.2%, respectively (p=0.532). Conclusions: In cT1-2N0 breast cancer patients treated with BCT, omission of SLNB resulted in a non-inferior median 5-year RR and DDFS compared with SLNB. These premature findings support the omission of SLNB, at least in case of cT1N0, ER+, grade 1-2 breast cancer. This study further demonstrates that adjuvant hormonal therapy should not be a prerequisite for omission of the SLNB. Citation Format: R. J. Schipper, L. M. van Roozendaal, V. M. Wintraecken, J. M. Simons, M. Moossdorff, E. J. T. Luiten, F. van Duijnhoven, L. de Munck, L. F. C. Dols, R. Koelemij, R. van Eekeren, A. B. Francken, T. van Dalen, K. Keymeulen, J. Volders, J. A. van der Hage, H. Torrenga, P. A. Neijenhuis, P. Nijhuis, D. van Uden, E. Heuts, M. A. Bessems, C. D. Dirksen, M. H. Martens, M. F. Bouwmeester, K. Schenk, A. V. R. J. Bell, S. Maaskant-Braat, L. J. A. Strobbe, S. C. Linn, P. M. P. Poortmans, M. L. G. Vane, V. C. G. Tjan-Heijnen, K. K. B. T. van der Vijver, M. B. I. Lobbes, J. de Vries, L. Emelianova-Hiddink, J. Kandt, L. J. Boersma, J. H. W. de Wilt, S. M. J. van Kuijk, M. L. Smidt, BOOG 2013-08 Study Group. Omission of sentinel lymph node biopsy in clinically T1-2 node-negative breast cancer patients treated with breast-conserving therapy: results of the Dutch BOOG 2013-08 randomized controlled trial after a median follow-up of 5 years [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr GS2-11.

In 2023, new ACR/EULAR classification criteria for research on the antiphospholipid syndrome (APS) were published. This Delphi consensus paper aims to examine the implications of these criteria and to update on recent diagnostic and therapeutic insights for APS in clinical practice. A panel of 19 Dutch experts participated in two survey rounds and a final discussion to achieve agreement. Consensus was defined as a median score of ≥7, indicating strong agreement, or a score of ≤3, indicating strong disagreement. 23 of 25 statements (92%) achieved consensus. The panel concluded that the new classification criteria improve risk stratification for research purposes but are not designed for clinical diagnosis. A significant proportion of patients with obstetric APS do not fulfil these research criteria. New is the emphasis on microvascular disease. Recognizing these lesser-known APS manifestations could facilitate earlier diagnosis and improve patient outcomes. Laboratory standardization remains a significant challenge. Current treatment recommendations favor vitamin K antagonists, but direct oral anticoagulants or antiplatelet therapy may be cautiously considered in selected low-risk patients.

Background: Early surgical intervention is associated with improved outcomes in hip fracture care, yet in patients using Direct Oral Anticoagulants (DOACs), surgery is frequently delayed due to concerns about increased intraoperative bleeding. Despite the increasing prevalence of hip fracture patients on DOACs, no consensus exists on optimal surgical timing. This has led to substantial practice variation between hospitals, with some operating within 24 h of last DOAC intake and others delaying surgery beyond 24 h. This study hypothesizes that early surgery within 24 h results in a non-inferior blood transfusion risk compared to delayed surgery 24 h or more after last DOAC intake in hip fracture patients on DOACs. This protocol describes the design and methodological rationale of a natural experiment. Methods and analysis: A multicenter cohort study designed as a natural experiment will be conducted across seven Dutch level 2 trauma centers, using predefined and standardized prospectively collected variables from electronic health records. Centers will adhere to distinct local surgical timing protocols, forming two cohorts: early surgery within 24 h and delayed surgery 24 h or more after last DOAC intake. Patients presenting with an isolated hip fracture who are using a DOAC and have taken their last dose within 24 h before admission will be included. The primary endpoint is postoperative blood transfusion. Secondary endpoints include additional bleeding-related outcomes, thrombotic and postoperative complications, and hospital length of stay. The primary analysis will be conducted on a per-protocol basis, with an intention-to-treat analysis performed as a supplementary assessment. Non-inferiority will be established if the upper bound of the one-sided 95% confidence interval for the risk difference does not exceed the predefined margin of 5%. Ethics and dissemination: Ethical approval was obtained from the Medical Ethics Committee United, Utrecht, The Netherlands. As this is a cohort study without altering clinical care, individual informed consent is not required. All data will be pseudonymized, and findings will be disseminated through peer-reviewed journals and scientific conferences. Registration details: Medical Ethics Committee United, Utrecht, The Netherlands, registration number W25.034.

Aim:Fractional Polynomial (FP) models are widely used in survival analysis for health technology assessment and network meta-analysis (NMA). However, current implementations rely on a fixed set of pre-specified powers, which may constrain model flexibility, limit predictive performance and increase computational cost in Bayesian settings. This study introduces and evaluates a Bayesian FP modeling approach in which the powers are estimated as continuous parameters rather than fixed, aiming to simplify model selection and improve fit.Materials & methods:Second-order Bayesian FP models were implemented in STAN, allowing the time transformation powers (p1, p2) to be estimated from the data. Model performance was evaluated across three oncology NMA datasets; in advanced non-small-cell lung cancer, metastatic prostate cancer and early breast cancer. The performance was assessed using visual fit, leave-one-out-information-criteria, root mean square error, incremental survival estimates and computational efficiency. Validation steps included posterior predictive checks, sensitivity analyses and long-term extrapolation.Results:Across all datasets, variable power models consistently achieved better statistical fit (lower leave-one-out-information-criteria and root mean square error) than fixed power models. Incremental survival estimates were also more stable and clinically plausible, particularly in datasets with complex hazard dynamics. While variable models required slightly more time per run, the approach greatly reduced the number of required model configurations, leading to lower overall computational burden.Conclusion:Bayesian FP models with variable powers not only improve model fit and simplify model selection but also reduce structural uncertainty by replacing exhaustive grid searches with a unified, data-driven estimation of transformation powers, while retaining interpretability and computational efficiency. By producing robust, well-calibrated survival projections and streamlining model selection, this approach strengthens survival analysis for health technology assessment and supports more reliable decision-making in comparative effectiveness research.

Atrial fibrillation (AF) is common in the elderly population and is associated with a high risk of thromboembolic events. Although non-vitamin K oral anticoagulants (NOACs) are the preferred drugs in antithrombotic therapy for AF, Vitamin K Anticoagulant drug (VKA) treatment is still used in a considerable proportion of patients with AF. Moreover, recent findings revealed that switching VKA to NOAC is associated with more bleeding complications in frail older patients with AF. Standard of care (SOC) monitoring of VKA treatment consists of venous blood sampling and back office dosage advice with a chain of processes and involvement of several health care professionals. We have designed a new procedure for monitoring (Near Patient Therapeutic Monitoring / NPTM) in order to improve the quality and safety of VKA treatment. NPTM consists of INR measurement with a point-of-care (POC) device in the home setting of a patient, performed by one professional and with an instant dosage advice. This is a cluster-randomised, parallel group, open label study to compare SOC with NPTM of VKA treatment in patients in a home setting. The follow-up period was one year. The primary outcome was time in therapeutic range (TTR), and secondary outcomes were adverse events (deaths, bleeding and thromboembolic events). 555 Patients were included in the study. After randomisation, 271 patients received SOC and 284 patients received NPTM. The TTR did not differ significantly: 63.71% versus 62.47% (p > 0.05) for SOC and NPTM, respectively. Significant differences were found for all-cause death (SOC n = 34 versus NPTM n = 16, p < 0.05, OR 0.47, 95% CI: 0.25-0.87), total number of minor bleedings (79 events in SOC vs 52 in NPTM, p < 0.05, OR 64 (95%CI: 0,37-0,81) and all non-major bleedings (100 events in SOC vs 67 in NPTM, p < 0.05, OR 0.62 (95% CI: 043-0.90). NPTM of VKA treatment in AF-patients does not result in an improved TTR when compared to SOC. All-cause death, total number of minor bleedings and all non-major bleedings may be reduced in NPTM, although the study was not powered for these secondary outcomes. Future studies are needed to determine the cost-effectiveness of NTPM versus SOC.