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.

[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.

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.