Table 0; documenting the steps to go from clinical database to research dataset.

OBJECTIVES: Data-driven decision support tools have been increasingly recognized to transform health care. However, such tools are often developed on predefined research datasets without adequate knowledge of the origin of this data and how it was selected. How a dataset is extracted from a clinical database can profoundly impact the validity, interpretability and interoperability of the dataset, and downstream analyses, yet is rarely reported. Therefore, we present a case study illustrating how a definitive patient list was extracted from a clinical source database and how this can be reported. STUDY DESIGN AND SETTING: A single-center observational study was performed at an academic hospital in the Netherlands to illustrate the impact of selecting a definitive patient list for research from a clinical source database, and the importance of documenting this process. All admissions from the critical care database admitted between January 1, 2013, and January 1, 2023, were used. RESULTS: An interdisciplinary team collaborated to identify and address potential sources of data insufficiency and uncertainty. We demonstrate a stepwise data preparation process, reducing the clinical source database of 54,218 admissions to a definitive patient list of 21,553 admissions. Transparent documentation of the data preparation process improves the quality of the definitive patient list before analysis of the corresponding patient data. This study generated seven important recommendations for preparing observational health-care data for research purposes. CONCLUSION: Documenting data preparation is essential for understanding a research dataset originating from a clinical source database before analyzing health-care data. The findings contribute to establishing data standards and offer insights into the complexities of preparing health-care data for scientific investigation. Meticulous data preparation and documentation thereof will improve research validity and advance critical care.

Causes for Medical Errors in Obstetrics and Gynaecology.

Background: Quality strategies, interventions, and frameworks have been developed to facilitate a better understanding of healthcare systems. Reporting adverse events is one of these strategies. Gynaecology and obstetrics are one of the specialties with many adverse events. To understand the main causes of medical errors in gynaecology and obstetrics and how they could be prevented, we conducted this systematic review. Methods: This systematic review was performed in compliance with the Prisma 2020 guidelines. We searched several databases for relevant studies (Jan 2010-May 2023). Studies were included if they indicated the presence of any potential risk factor at the hospital level for medical errors or adverse events in gynaecology or obstetrics. Results: We included 26 articles in the quantitative analysis of this review. Most of these (n = 12) are cross-sectional studies; eight are case-control studies, and six are cohort studies. One of the most frequently reported contributing factors is delay in healthcare. In addition, the availability of products and trained staff, team training, and communication are often reported to contribute to near-misses/maternal deaths. Conclusions: All risk factors that were found in our review imply several categories of contributing factors regarding: (1) delay of care, (2) coordination and management of care, and (3) scarcity of supply, personnel, and knowledge.

Impact of practicing internal benchmarking on continuous improvement of cataract surgery outcomes: a retrospective observational study at Aravind Eye Hospitals, India.

OBJECTIVE: We aim to assess the effectiveness of a cataract surgery outcome monitoring tool used for continuous quality improvement. The objectives are to study: (1) the quality parameters, (2) the monitoring process followed and (3) the impact on outcomes. DESIGN AND PROCEDURES: In this retrospective observational study we evaluated a quality improvement (QI) method which has been practiced at the focal institution since 2012: internal benchmarking of cataract surgery outcomes (CATQA). We evaluated quality parameters, procedures followed and clinical outcomes. We created tables and line charts to examine trends in key outcomes. SETTING: Aravind Eye Care System, India. PARTICIPANTS: Phacoemulsification surgeries performed on 718 120 eyes at 10 centres (five tertiary and five secondary eye centres) from 2012 to 2020 were included. INTERVENTIONS: An internal benchmarking of surgery outcome parameters, to assess variations among the hospitals and compare with the best hospital. OUTCOME MEASURES: Intraoperative complications, unaided visual acuity (VA) at postoperative follow-up visit and residual postoperative refractive error (within ±0.5D). RESULTS: Over the study period the intraoperative complication rate decreased from 1.2% to 0.6%, surgeries with uncorrected VA of 6/12 or better increased from 80.8% to 89.8%, and surgeries with postoperative refractive error within ±0.5D increased from 76.3% to 87.3%. Variability in outcome measures across hospitals declined. Additionally, benchmarking was associated with improvements in facilities, protocols and processes. CONCLUSION: Internal benchmarking was found to be an effective QI method that enabled the practice of evidence-based management and allowed for harnessing the available information. Continuous improvement in clinical outcomes requires systematic and regular review of results, identifying gaps between hospitals, comparisons with the best hospital and implementing lessons learnt from peers.

Managing Outpatient Cycle Times in Hospitals Using Integrated Closed-Loop Approaches.

Long waiting times in outpatient clinics have multiple adverse effects on patients and their attendants, staff and hospital management. Several approaches practiced to manage the cycle time have been proposed. The purpose of this study was to evaluate the impact of implementing closed-loop based multiple approaches together. This study was conducted in Aravind Eye Hospital (AEH), Madurai, India where several approaches to manage cycle times have been implemented over the years. Scheduling system was introduced to manage COVID-19 specific norms. We compared the cycle times in general outpatient clinics in a regime in which multiple approaches were practiced together before and after introducing scheduling to regimes in which individual approaches were practiced. We analysed how the cycle time varied by patient load. Cycle time for all patient days when the combined approach was used was 19% lower than baseline, and better than under each of the individual approaches. The outcome sustained even during the COVID-19 pandemic that necessitated additional processes and procedures. Therefore, implementing multiple approaches can be more effective to reduce the cycle time than implementing individual approaches.

Quantifying the Resilience of a Healthcare System: Entropy and Network Science Perspectives.

In this study, we consider the human body and the healthcare system as two complex networks and use theories regarding entropy, requisite variety, and network centrality metrics with resilience to assess and quantify the strengths and weaknesses of healthcare systems. Entropy is used to quantify the uncertainty and variety regarding a patient's health state. The extent of the entropy defines the requisite variety a healthcare system should contain to be able to treat a patient safely and correctly. We use network centrality metrics to visualize and quantify the healthcare system as a network and assign the strengths and weaknesses of the network and of individual agents in the network. We apply organization design theories to formulate improvements and explain how a healthcare system should adjust to create a more robust and resilient healthcare system that is able to continuously deal with variations and uncertainties regarding a patient's health, despite possible stressors and disturbances at the healthcare system. In this article, these concepts and theories are explained and applied to a fictive and a real-life example. We conclude that entropy and network science can be used as tools to quantify the resilience of healthcare systems.

Trends and Developments in Medical Liability Claims in The Netherlands.

Recent data on number of claims, final judgement of claims and their costs are scarce. This study analyzes 15 years of malpractice claims in the Netherlands. All claims filed, and all claims closed by two insurance companies (which insure approximately 95% of all hospitals in the Netherlands) between 2007-2021 are included. Trends in number of claims, medical specialties involved, final judgements and costs from malpractice claims are analyzed, as well as the impact of COVID-19 on malpractice claims. In total, 20,726 claims were filed and 21,826 claims were closed. Since 2013, the number of claims filed decreased. Of all claims filed, 64% were aimed at surgical specialties and 18% at contemplative specialties. Of all claims closed, 24.49% were accepted, 19.26% were settled and 48.94% got rejected. The financial burden of all claims closed quadrupled between 2007 and 2021; this increase was caused by rare cases with excessively high costs. Since the COVID-19 pandemic, we observed a decrease in the number of claims filed, and the number of incidents reported. This study provides valuable insights into trends and developments in the number and costs of liability claims, which is the first step towards improving patient safety and preventing incidents and malpractice claims.

[Health care claims per medical specialty in the Netherlands: a 10-year overview]. / Schadeclaims per medisch specialisme.

OBJECTIVE: To analyse the quantity and size of health care claims per medical specialty in the past 10 years. DESIGN: Descriptive, evaluative and comparative study. METHOD: Anonymised damage claim data from Centramed and MediRisk were used for this study. The numbers and sizes of the claims per specialty have been analysed over a ten-year period and plotted against production numbers of the various specialties, calculated on the basis of DBC data. All damage claims were related to regular hospital care in the Netherlands and were submitted or closed in the period from 1 January 2007 to 31 December 2016. RESULTS: A total of 15,115 claims were submitted during the period under study. 16.2% of these were related to non-surgical specialties, 64.7% to surgical specialties, 10.8% to supporting specialties, 0.7% to paramedics working at the hospital and the specialty was impossible to find out for 7.6% of them. The total cost of all damage claims closed during the study period was € 229,224,433. Of the total damage burden, 19% was paid out to patients with claims against non-surgical specialties and 63% to patients with claims against surgical specialties. General surgery, orthopaedics and gynaecology together were responsible for 47% of all submitted claims for damages and for 52% of the damage burden. CONCLUSION: General surgery, orthopaedics and gynaecology invariably are, just as in previous studies, the specialties with the highest number of damage claims and the largest damage burden. Even when corrected for production volumes, these specialties comparatively have the most and most expensive damage claims.

[More and higher claims for damages: analysis of claims for damages in Dutch hospital care 2007-2016]. / Meer en hogere schadeclaims.

OBJECTIVE: To investigate the number and extent of claims concerning hospital care at a national level, thereby affording insight to the profession. DESIGN: A quantitative, descriptive and comparative study. METHOD: We used anonymised data on all claims for damages from regular hospital care that were submitted to Centramed and MediRisk between 1 January 2007 and 31 December 2016. Between them, these two companies are the insurers of 95% of all Dutch hospitals. Using SPSS and Mathematica, we analysed the number of claims submitted, the average duration of the procedures, the manner in which they were settled, developments in the total cost of claims, and the settlements paid out to claimants. RESULTS: A total of 15,115 claims were made between 2007 and 2016. Up to 2013, the number of claims increased annually, thereafter this stabilised. In 2016, 4.5% more claims were submitted than in 2007. During the same period, 15,306 claims were closed. The total claim-related cost was € 229,191,033 and showed a clearly rising trend throughout this period. In 2016 the cost of claims was four-and-a-half times as high as in 2007. CONCLUSION: The number of claims being made is rising, but not as quickly as the cost of claims which increased fivefold during the period under investigation. Compared with previous investigations, both the number and the extent of the claims increased significantly between 2007 and 2016.

Simple Rules, Not So Simple: The Use of International Ovarian Tumor Analysis (IOTA) Terminology and Simple Rules in Inexperienced Hands in a Prospective Multicenter Cohort Study.

OBJECTIVES: To analyze how well untrained examiners - without experience in the use of International Ovarian Tumor Analysis (IOTA) terminology or simple ultrasound-based rules (simple rules) - are able to apply IOTA terminology and simple rules and to assess the level of agreement between non-experts and an expert. METHODS: This prospective multicenter cohort study enrolled women with ovarian masses. Ultrasound was performed by non-expert examiners and an expert. Ultrasound features were recorded using IOTA nomenclature, and used for classifying the mass by simple rules. Interobserver agreement was evaluated with Fleiss' kappa and percentage agreement between observers. RESULTS: 50 consecutive women were included. We observed 46 discrepancies in the description of ovarian masses when non-experts utilized IOTA terminology. Tumor type was misclassified often (n = 22), resulting in poor interobserver agreement between the non-experts and the expert (kappa = 0.39, 95 %-CI 0.244 - 0.529, percentage of agreement = 52.0 %). Misinterpretation of simple rules by non-experts was observed 57 times, resulting in an erroneous diagnosis in 15 patients (30 %). The agreement for classifying the mass as benign, malignant or inconclusive by simple rules was only moderate between the non-experts and the expert (kappa = 0.50, 95 %-CI 0.300 - 0.704, percentage of agreement = 70.0 %). The level of agreement for all 10 simple rules features varied greatly (kappa index range: -0.08 - 0.74, percentage of agreement 66 - 94 %). CONCLUSION: Although simple rules are useful to distinguish benign from malignant adnexal masses, they are not that simple for untrained examiners. Training with both IOTA terminology and simple rules is necessary before simple rules can be introduced into guidelines and daily clinical practice.

Investigating the performance and cost-effectiveness of the simple ultrasound-based rules compared to the risk of malignancy index in the diagnosis of ovarian cancer (SUBSONiC-study): protocol of a prospective multicenter cohort study in the Netherlands.

BACKGROUND: Estimating the risk of malignancy is essential in the management of adnexal masses. An accurate differential diagnosis between benign and malignant masses will reduce morbidity and costs due to unnecessary operations, and will improve referral to a gynecologic oncologist for specialized cancer care, which improves outcome and overall survival. The Risk of Malignancy Index is currently the most commonly used method in clinical practice, but has a relatively low diagnostic accuracy (sensitivity 75-80% and specificity 85-90%). Recent reports show that other methods, such as simple ultrasound-based rules, subjective assessment and (Diffusion Weighted) Magnetic Resonance Imaging might be superior to the RMI in the pre-operative differentiation of adnexal masses. METHODS/DESIGN: A prospective multicenter cohort study will be performed in the south of The Netherlands. A total of 270 women diagnosed with at least one pelvic mass that is suspected to be of ovarian origin who will undergo surgery, will be enrolled. We will apply the Risk of Malignancy Index with a cut-off value of 200 and a two-step triage test consisting of simple ultrasound-based rules supplemented -if necessary- with either subjective assessment by an expert sonographer or Magnetic Resonance Imaging with diffusion weighted sequences, to characterize the adnexal masses. The histological diagnosis will be the reference standard. Diagnostic performances will be expressed as sensitivity, specificity, positive and negative predictive values and likelihood ratios. DISCUSSION: We hypothesize that this two-step triage test, including the simple ultrasound-based rules, will have better diagnostic accuracy than the Risk of Malignancy Index and therefore will improve the management of women with adnexal masses. Furthermore, we expect this two-step test to be more cost-effective. If the hypothesis is confirmed, the results of this study could have major effects on current guidelines and implementation of the triage test in daily clinical practice could be a possibility. TRIAL REGISTRATION: ClinicalTrials.gov: registration number NCT02218502.

Female sterilization and refertilization.

OBJECTIVE: To analyze data on sterilization and refertilization procedures that took place at Orbis Medical Center in Sittard, a hospital in the south of the Netherlands. STUDY DESIGN: Retrospective cohort study of surgical tubal sterilizations performed on 966 patients for contraception between 2002 and 2011, and of 19 patients who underwent refertilization between 2002 and 2012. The main outcome measures were complications and failure rates of sterilization, motives for refertilization and pregnancy rates after refertilization. The t test and nonparametric tests were used to determine differences between groups and proportions. RESULTS: Between 2002 and 2011, the number of sterilizations declined. Almost all the patients (99.8%) underwent laparoscopic sterilization. The most common method of sterilization used Filshie clips, and was used in 99.7% of the women. The median age at the time of sterilization was 37 years. The failure rate was 0.3%. All procedures were uneventful. The number of refertilizations during this time period also declined. The median time between sterilization and refertilization was 65 months. Patients who underwent refertilization were significantly younger at time of sterilization than patients who did not (p<0.001). After refertilization, 12 patients (63.2%) became pregnant. CONCLUSIONS: The complication and failure rates of laparoscopic sterilization are low. The number of laparoscopic sterilizations and the number of refertilizations are both declining. Still, refertilization is a safe procedure and gives a significant chance of becoming pregnant.

Women's prelabour preference for epidural analgesia: a cross-sectional study among women from the Netherlands and Belgium.

BACKGROUND: This study describes variables related to women's prelabour preference for epidural analgesia (PEA) in two neighbouring countries with a comparable socio-economic and cultural background. METHODS: Dutch women in midwifery (n = 164) or obstetrical care (n = 162), and Belgian women (n = 188) of ≥36 weeks gestation with a singleton in cephalic presentation completed questionnaires on demographic factors, received labour analgesia information, perceived attitude of the caregiver towards epidural analgesia (EA), pain catastrophising and coping with labour pain. Multiple logistic regression analysis was performed with PEA as dependent variable. RESULTS: PEA was 9.9% in Dutch midwifery care, 25.5% in Dutch obstetrical care and 38.3% in Belgian care (p value < 0.001). In the Netherlands, maternal age of 35 years or older (OR 4.95; 95% confidence interval (CI) 2.03-12.08), positive attitude of the caregiver towards EA (OR 5.83; 95% CI 2.57-13.23) and a lower degree of coping (OR 3.61; 95% CI 2.24-5.82) were independently associated with PEA. In Belgium, only a lower degree of coping was associated with PEA (OR 4.06; 95% CI 2.45-6.73). CONCLUSIONS: In both countries, women with a lower degree of coping had a higher PEA. Care setting in the Netherlands was not an independent variable.

Imperforate hymen: a cause of abdominal pain in female adolescents.

A 16-year-old girl presented with primary amenorrhea and had had cyclical abdominal pain for almost a year. At examination we observed a painful mass in the lower abdomen and normal secondary sex characteristics. Perineal examination showed a bluish bulging hymen. Transabdominal ultrasonography revealed a dense mass in the pelvis measuring about 12×11 cm. We diagnosed an imperforate hymen with haematocolpos and haematometra. The hymen was opened surgically and a large quantity of menstrual blood was drained from the vagina and uterus. Postoperative recovery was normal without any pain. The patient now menstruates regularly. An imperforate hymen occurs in 0.05% of women. It is important to be aware of this while examining a female adolescent presenting with cyclical abdominal pain and primary amenorrhea. Late discovery of an imperforate hymen may lead to pain, infections, hydronephrosis and endometriosis with subfertility as a possible consequence.