Dutch University Medical Centers Research Articles

Outpatient Video Visits During the COVID-19 Pandemic: Cross-Sectional Survey Study of Patients' Experiences and Characteristics.

During the first lockdown of the COVID-19 pandemic, an exponential increase in video consultations replacing in-person outpatient visits was observed in hospitals. Insight into patients' experiences with this type of consultation is helpful for a broad, sustainable, and patient-centered implementation of video consultation. This study aims to examine patients' experiences with video consultation during the COVID-19 pandemic and identify discriminative patient and consultation characteristics to determine when video consultation is most feasible. A cross-sectional survey study was conducted. Patients aged ≥18 years and scheduled for a video consultation at the outpatient clinic of a Dutch university medical center from August 2020 to December 2020 for all medical specialties were eligible. Patients' experiences were explored through a study-specific survey using descriptive quantitative statistics. Open-ended questions were qualitatively analyzed and thematically categorized into appreciated aspects and aspects for improvement. Discriminative patient and consultation characteristics were identified using 3 distinctive survey items. Characteristics of patients who scored and those who did not score all 3 items positively were analyzed using binary logistic regression. A total of 1054 patients were included in the analysis. Most patients (964/1054, 91.46%) were satisfied with their video consultation, with a mean overall grade of 8.6 (SD 1.3) of 10. In the qualitative analyses, 70.02% (738/1054) of the patients cited aspects they appreciated and 44.97% (474/1054) mentioned aspects for improvement during their consultation. Patients with better self-rated health reported a positive evaluation significantly more often (P=.001), which also held true for other medical specialties (vs surgical and nonsurgical specialties; P<.001). Video consultation was perceived as highly satisfactory by patients during the COVID-19 pandemic, with the best experience reported by healthy participants and those undergoing their first consultation. Appreciated aspects are mainly at the individual professional level, organizational level, and innovation level itself. The aspects that were mentioned for improvement can be changed for the better.

Unravelling Low-Value Care Decision-Making: Residents' Perspectives on the Influence of Contextual Factors.

Several initiatives have been developed to target low-value care (i.e. waste) in decision-making with varying success. As such, decision-making is a complex process and context's influence on decisions concerning low-value care is limitedly explored. Hence, a more detailed understanding of residents' decision-making is needed to reduce future low-value care. This study explores which contextual factors residents experience to influence their decision-making concerning low-value care. Methods: We employed nominal group technique to select four low-value care vignettes. Prompted by these vignettes, we conducted individual interviews with residents. We analyzed the qualitative data thematically using an inductive-deductive approach, guided by Bronfenbrenner's social-ecological framework. This framework provided guidance to 'context' in terms of sociopolitical, environmental, organizational, interpersonal, and individual levels. In 2022, we interviewed 19 residents from a Dutch university medical center. We identified 33 contextual factors influencing residents' decision-making, either encouraging or discouraging low-value care. The contextual factors resided in the following levels with corresponding categories: (1) environmental and sociopolitical: society, professional medical association, and governance; (2) organizational: facility characteristics, social infrastructure, and work infrastructure; (3) interpersonal: resident-patient, resident-supervising physician, and resident-others; and (4) individual: personal attributes and work structure. This paper describes 33 contextual factors influencing residents' decision-making concerning low-value care. Residents are particularly influenced by factors related to interactions with patients and supervisors. Furthermore, organizational factors and the broader environment set margins within which residents make decisions. While acknowledging that a multi(faceted)-intervention approach targeting all contextual factors to discourage low-value care delivery may be warranted, improving communication skills in the resident-patient dynamics to recognize and explain low-value care seems a particular point of interest over which residents can exercise an influence themselves.

DOP72 Pregnancy for IBD-patients with an enterostomy is feasible but is associated with complications

Abstract Background As inflammatory bowel disease (IBD) is frequently diagnosed in young adults, the disease often coincides with pregnancy. There are several indications for enterostomies in the treatment of IBD. Literature on enterostomy complications during pregnancy and pregnancy-outcomes remains scarce. Gaining insight in the incidence of complications and the course of these pregnancies serves as a first step in developing guidelines for the difficult question of how, when and by whom complications during pregnancy should be monitored and treated. The aim of this study was to assess enterostomy related complications and pregnancy-outcomes in female IBD patient with an enterostomy during pregnancy. Methods For this multicenter cohort and survey study, all patients who have been pregnant while having an enterostomy and who gave birth between 2016 and 2023 in three Dutch university medical centers were included. Complications of the enterostomy and pregnancy-outcomes were collected retrospectively from electronic patient files. In collaboration with gastroenterologists, surgeons, gynaecologists and IBD-patients, a survey was designed. Through this digital questionnaire, all participants were asked about their experience during pregnancy and any long-term enterostomy related complaints. Results Data was collected on 37 patients (mean age at conception 32.6 years; 64.9% Crohn’s disease (CD), 32.4% ulcerative colitis (UC), 2.7% IBD undetermined (IBD-U)), comprising 48 pregnancies of which four ended in a miscarriage. Enterostomy related complications occurred in thirty of the full-term pregnancies (68.2%), with decreased stoma-output (43.2%), small-bowel obstruction (29.6%) and leakage (25%) being the most prevalent. In a quarter of the pregnancies, surgical revision of the stoma was needed due to obstruction (27.3%), prolapse (27.3) and peristomal herniation (45.6%). A full overview of documented complications can be found in table 1. Of the fourteen women who completed the questionnaire, six reported non-resolved complications at least six months after delivery (42.9%). Eighteen pregnancies ended in a caesarean section (40.9%). There were 45 infants (one gemelli pregnancy), of whom eight (17.8 %) were born prematurely,eight (17.8 %) had low birth weight (17.8%) and eight (17.8 %) were small for their gestational age. Conclusion Being pregnant and giving birth with an enterostomy is feasible, but is in two third of pregnancies associated with complications. A reduced stoma output and leakage can be prevented by early counseling. Proper guidance before, during pregnancy and postpartum is therefore crucial for IBD-patients with an enterostomy.

When routine becomes stressful: A qualitative study into resuscitation team members’ perception of stress and performance

ABSTRACT Interprofessional teamwork is of high importance during stressful situations such as CPR. Stress can potentially influence team performance. This study explores the perception of stress and its stressors during performance under pressure, to be able to further adjust or develop training. Healthcare professionals, who are part of the resuscitation team in a large Dutch university medical center, discussed their experiences in homogeneous focus groups. Nine focus groups and one individual interview were conducted and analyzed thematically, in order to deepen our understanding of their experiences. Thematic analysis resulted in two scenarios, routine and stress and an analysis of accompanying team processes. Routine refers to a setting perceived as straightforward. Stress develops in the presence of a combination of stressors such as a lack of clarity in roles and a lack of knowledge on fellow team members. Participants reported that stress affects the team, specifically through an altering of communication, a decrease in situational awareness, and formation of subgroups. This may lead to a further increase in stress, and potentially result in a vicious cycle. Team processes in a stressful situation like CPR can be disrupted by different stressors, and might affect the team and their performance. Improved knowledge about the stressors and their effects might be used to design a training environment representative for the performance setting healthcare professionals work in. Further research on the impact of representative training with team-level stressors and the development of a “team brain” might be worthwhile.

Nationwide Outcome of Tailored Surgery for Symptomatic Chronic Pancreatitis based on Pancreatic Morphology

Objective: To determine the nationwide use and outcome of tailored surgical treatment for symptomatic chronic pancreatitis (CP) as advised by recent guidelines. Summary background data: Randomized trials have shown that surgery is superior to endoscopy in patients with symptomatic CP, although endoscopy remains popular Recent guidelines advice to “tailor surgery” based on pancreatic morphology meaning that the least extensive procedure should be selected based on pancreatic morphology. However, nationwide, and multicenter studies On tailored surgery for symptomatic CP are lacking. Methods: Nationwide multicenter retrospective analysis of consecutive patients undergoing surgical treatment for symptomatic CP in all seven Dutch university medical centers (2010-2020). Outcomes included volume trend, major complications, 90-day mortality, postoperative opioid use and clinically relevant pain relief. Surgical treatment was tailored based on the size of the main pancreatic duct and pancreatic head (e.g. surgical drainage for a dilated pancreatic duct, and normal size pancreatic head). Results: Overall, 381 patients underwent surgery for CP: 127 surgical drainage procedures ( 33%; mostly extended lateral pancreaticojejunostomy), 129 duodenum-preserving pancreatic head resections (DPPHR, 34%, mostly Frey), and 125 formal pancreatic resections (33%, mostly distal pancreatectomy). The annual surgical volume increased slightly (Pearson r=0.744). Mortality (90-day) occurred in 6 patients (2%), and was non-significantly lower after surgical drainage (0%, 3%, 2%; P=0.139). Major complications (12%, 24%, 26%; P=0.012), postoperative pancreatic fistula grade B/C (0%, 3%, 22%; P=0.038), surgical reintervention (4%, 16%, 12%; P=0.006), and endocrine insufficiency ( 14%, 21%, 43%; P&lt;0.001) occurred less often after surgical drainage. After a median follow-up of 11 months [IQR 3-23] good rates of clinically relevant pain relief ( 83%, 69%, 80%; P=0.082) were observed and 81% of opioid users had stopped using (83%, 78%, 84%, P=0.496). Conclusion: The use of surgery for symptomatic CP increased over the study period. Drainage procedures were associated with the best safety profile and excellent functional outcome, highlighting the importance of tailoring surgery based on pancreatic morphology.

Correctly structured problem lists lead to better and faster clinical decision-making in electronic health records compared to non-curated problem lists: A single-blinded crossover randomized controlled trial

BackgroundCorrectly structured problem lists in electronic health records (EHRs) offer major benefits to patient care. Without structured lists, diagnosis information is often scatteredly documented in free text, which may contribute to errors and inefficient information retrieval. This study aims to assess whether EHRs with correctly structured problem lists result in better and faster clinical decision-making compared to non-curated problem lists. MethodsTwo versions of two patient records (A and B) were created in an EHR training environment: one version included diagnosis information structured and coded on the problem list (“correctly structured problem list”), the other version had missing problem list diagnoses and diagnosis information partly documented in free text (“non-curated problem list”). In this single-blinded crossover randomized controlled trial, healthcare providers, who can prescribe medications, from two Dutch university medical center locations first evaluated a randomized version of patient A, then B. Participants were asked to motivate their answer to two medication prescription questions. One (test) question required information similarly presented in both record versions. The second (comparison) question required information documented on problem lists and/or in notes. The primary outcome measure was the correctness of the motivated answer to the comparison question. Secondary outcome measure was the time to answer and motivate both questions correctly. ResultsAs planned, 160 participants enrolled. Two were excluded for not meeting inclusion criteria. Correctly structured problem lists increased providers’ ability to answer the comparison question correctly (56.3 % versus 33.5 %, McNemar odds ratio 2.80 (1.65–4.93) 95 %-CI). Median time to answer both questions correctly was significantly lower for EHRs with correctly structured problem lists (Wilcoxon-signed-rank test p = 0.00002, with incorrect answers coded equally at slowest time). ConclusionsCorrectly structured problem lists lead to better and faster clinical decision-making. Increased structured problem lists usage may be warranted for which implementation policies should be developed.

Diversity of Parent Emotions and Physician Responses During End-of-Life Conversations.

To provide support to parents of critically ill children, it is important that physicians adequately respond to parents' emotions. In this study, we investigated emotions expressed by parents, physicians' responses to these expressions, and parents' emotions after the physicians' responses in conversations in which crucial decisions regarding the child's life-sustaining treatment had to be made. Forty-nine audio-recorded conversations between parents of 12 critically ill children and physicians working in the neonatal and pediatric intensive care units of 3 Dutch university medical centers were coded and analyzed by using a qualitative inductive approach. Forty-six physicians and 22 parents of 12 children participated. In all 49 conversations, parents expressed a broad range of emotions, often intertwining, including anxiety, anger, devotion, grief, relief, hope, and guilt. Both implicit and explicit expressions of anxiety were prevalent. Physicians predominantly responded to parental emotions with cognition-oriented approaches, thereby limiting opportunities for parents. This appeared to intensify parents' expressions of anger and protectiveness, although their anxiety remained under the surface. In response to more tangible emotional expressions, for instance, grief when the child's death was imminent, physicians provided parents helpful support in both affect- and cognition-oriented ways. Our findings illustrate the diversity of emotions expressed by parents during end-of-life conversations. Moreover, they offer insight into the more and less helpful ways in which physicians may respond to these emotions. More training is needed to help physicians in recognizing parents' emotions, particularly implicit expressions of anxiety, and to choose helpful combinations of responses.

The National Coordinated Citrien eHealth Program to Scale Up Telemonitoring: Protocol for a Before-and-After Evaluation Study.

Sustainable implementation of telemonitoring in health care is challenging, especially if one aims to scale up telemonitoring initiatives nationwide. The National collaborative eHealth program in the Netherlands is supporting the nationwide upscaling of telemonitoring in 3 clinical domains by implementing telemonitoring in all Dutch university medical centers (UMCs). The chosen telemonitoring concepts are (1) telemonitoring solutions in the domain of cardiology, (2) telemonitoring solutions providing care from a distance in obstetrics, and (3) telemonitoring solutions monitoring vital functions in hospital wards. The aim of this study is to evaluate the upscaling of telemonitoring in Dutch university hospitals in order to gain a better knowledge of the process, methods, and outcomes of nationwide upscaling strategies. Our hypothesis is that by the completion of the Citrien program's scale-up, telemonitoring will be operational in all UMCs but not normalized in routine care. A before-and-after study will be conducted to assess upscaling. The theoretical frameworks used are the framework for nonadoption, abandonment, scale-up, spread, and sustainability; the Normalization Process Theory; and a project management tool Project Canvas. The primary outcome of the study is the degree of normalization to which health care providers at UMCs consider telemonitoring a part of their routine practice, measured using the Normalization MeAsurement Development tool (NoMAD). Our secondary outcome is the uptake of telemonitoring at the Dutch UMCs, using management data from UMCs' business intelligence systems query. Data will be collected between May 2020 and December 2022. Results were retrieved in June 2023. UMCs' business intelligence systems are queried for data for the secondary outcome measures. There is a risk that the UMCs will not be able to provide this management information. The laws and regulations governing telemonitoring in the Netherlands are changing, with the Electronic Data Exchange in Health Care Act (Wet elektronische gegevensuitwisseling in de zorg) and the European Health Data Space Act expected to positively influence implementation and upscaling. The Citrien program is a nationally coordinated change management program that is scaling up telemonitoring across contexts and settings. This study will produce original data on the uptake and upscaling of telemonitoring at Dutch UMCs. Future initiatives to implement eHealth in the health care sector may be guided by the wide range of success factors, obstacles, and experiences collected through this program. The network itself may be of great value impacting future acceleration of eHealth initiatives. DERR1-10.2196/45201.

Impact of performance and information feedback on medical interns' confidence–accuracy calibration

Diagnostic errors are a major, largely preventable, patient safety concern. Error interventions cannot feasibly be implemented for every patient that is seen. To identify cases at high risk of error, clinicians should have a good calibration between their perceived and actual accuracy. This experiment studied the impact of feedback on medical interns’ calibration and diagnostic process. In a two-phase experiment, 125 medical interns from Dutch University Medical Centers were randomized to receive no feedback (control), feedback on their accuracy (performance feedback), or feedback with additional information on why a certain diagnosis was correct (information feedback) on 20 chest X-rays they diagnosed in a feedback phase. A test phase immediately followed this phase and had all interns diagnose an additional 10 X-rays without feedback. Outcome measures were confidence–accuracy calibration, diagnostic accuracy, confidence, and time to diagnose. Both feedback types improved overall confidence–accuracy calibration (R2No Feedback = 0.05, R2Performance Feedback = 0.12, R2Information Feedback = 0.19), in line with the individual improvements in diagnostic accuracy and confidence. We also report secondary analyses to examine how case difficulty affected calibration. Time to diagnose did not differ between conditions. Feedback improved interns’ calibration. However, it is unclear whether this improvement reflects better confidence estimates or an improvement in accuracy. Future research should examine more experienced participants and non-visual specialties. Our results suggest that feedback is an effective intervention that could be beneficial as a tool to improve calibration, especially in cases that are not too difficult for learners.

Evaluation of a remote monitoring app in head and neck cancer follow-up care.

A remote monitoring app was developed for head and neck cancer (HNC) follow-up during the SARS-CoV-2 pandemic. This mixed-methods study provides insight in the usability and patients' experiences with the app to develop recommendations for future use. Patients were invited to participate if they were treated for HNC, used the app at least once and were in clinical follow-up. A subset was selected for semi-structured interviews through purposive sampling considering gender and age. This study was conducted between September 2021-May 2022 at a Dutch university medical center. 135 of the 216 invited patients completed the questionnaire, resulting in a total mHealth usability score of 4.72 (± 1.13) out of 7. Thirteen semi-structured interviews revealed 12 barriers and 11 facilitators. Most of them occurred at the level of the app itself. For example, patients received no feedback when all their answers were normal. The app made patients feel more responsible over their follow-up, but could not fulfill the need for personal contact with the attending physician. Patients felt that the app could replace some of the outpatient follow-up visits. Our app is user-friendly, makes patients feel more in control and remote monitoring can reduce the frequency of outpatient follow-up visits. The barriers that emerged must be resolved before the app can be used in regular HNC follow-up. Future studies should investigate the appropriate ratio of remote monitoring to outpatient follow-up visits and the cost-effectiveness of remote monitoring in oncology care on a larger scale.

SynthRAD2023 Grand Challenge dataset: Generating synthetic CT for radiotherapy.

Medical imaging has become increasingly important in diagnosing and treating oncological patients, particularly in radiotherapy. Recent advances in synthetic computed tomography (sCT) generation have increased interest in public challenges to provide data and evaluation metrics for comparing different approaches openly. This paper describes a dataset of brain and pelvis computed tomography (CT) images with rigidly registered cone-beam CT(CBCT) and magnetic resonance imaging (MRI) images to facilitate the development and evaluation of sCT generation for radiotherapy planning. The dataset consists of CT, CBCT, and MRI of 540 brains and 540 pelvic radiotherapy patients from three Dutch university medical centers. Subjects' ages ranged from 3 to 93 years, with a mean age of 60. Various scanner models and acquisition settings were used across patients from the three data-providing centers. Details are available in a comma separated value files provided with the datasets. The data is available on Zenodo (https://doi.org/10.5281/zenodo.7260704, https://doi.org/10.5281/zenodo.7868168) under the SynthRAD2023 collection. The images for each subject are available in nifti format. This dataset will enable the evaluation and development of image synthesis algorithms for radiotherapy purposes on a realistic multi-center dataset with varying acquisition protocols. Synthetic CT generation has numerous applications in radiation therapy, including diagnosis, treatment planning, treatment monitoring, and surgical planning.

Biomedical supervisors' role modeling of open science practices.

Supervision is one important way to socialize Ph.D. candidates into open and responsible research. We hypothesized that one should be more likely to identify open science practices (here publishing open access and sharing data) in empirical publications that were part of a Ph.D. thesis when the Ph.D. candidates' supervisors engaged in these practices compared to those whose supervisors did not or less often did. Departing from thesis repositories at four Dutch University Medical centers, we included 211 pairs of supervisors and Ph.D. candidates, resulting in a sample of 2062 publications. We determined open access status using UnpaywallR and Open Data using Oddpub, where we also manually screened publications with potential open data statements. Eighty-three percent of our sample was published openly, and 9% had open data statements. Having a supervisor who published open access more often than the national average was associated with an odds of 1.99 to publish open access. However, this effect became nonsignificant when correcting for institutions. Having a supervisor who shared data was associated with 2.22 (CI:1.19-4.12) times the odds to share data compared to having a supervisor that did not. This odds ratio increased to 4.6 (CI:1.86-11.35) after removing false positives. The prevalence of open data in our sample was comparable to international studies; open access rates were higher. Whilst Ph.D. candidates spearhead initiatives to promote open science, this study adds value by investigating the role of supervisors in promoting open science.

Upscaling telemonitoring in Dutch University Medical Centres: A baseline measurement

Introduction and objectiveThe Dutch university medical centres (UMC’s) are on the forefront when it comes to validation, implementation and research of telemonitoring. To aid the UMC’s in their effort, the Dutch Government has supported the UMC’s by fostering the ‘Citrien eHealth program’. This program aims at nationwide implementation and upscaling of telemonitoring via a collaborative network. To quantify the success of this program, this study aims to provide insights into the current adoption of telemonitoring by health care professionals (HCP) within Dutch UMC’s. MethodsBased on the evaluation framework as adapted from the Normalization Process Theory (NPT) a cross-sectional study was conducted in all Dutch UMC’s. Thirty healthcare professionals (HCPs) per UMC were invited to complete the 23-item Normalization MeAsure Development (NoMAD) questionnaire, a tool to assess the degree of normalisation of telemonitoring. ResultsThe over-all response rate was 52.4% (124/240). Over 80% of respondents agreed or strongly agreed that they understand how telemonitoring affects the nature of their work, with a mean score of 1.49 (N = 117, SD 0.74). HCPs reported to believe telemonitoring will become a normal part of their work in the near future (N = 124, mean = 8.67, SD = 1.38). Using the Wilcoxon signed-rank test, the difference between current practise and future use of telemonitoring predicts to be statistically significant (Z = − 7.505, p ≤ 0.001). Mean scores for appropriate training and sufficient resources are relatively low (2.39 and 2.70 respectively), indicating a barrier for collective action. ConclusionThis is the first study to assess the implementation of telemonitoring as standard practise across Dutch UMCs. The HCPs in this study are the frontrunners, believing that telemonitoring will become standard practise in the future despite the fact that it is currently not. Based on the results of this study, both educational and implementation strategies including practical skills training are highly recommended in order to scale up telemonitoring widely.

A research intelligence approach to assess the research impact of the Dutch university medical centres

BackgroundThe way in which research impact is evaluated and assessed has long been under debate. In recent years the focus is moving away from the use of numerical indicators, towards an emphasis on narratives. The Dutch university medical centres (UMCs) have a long-standing tradition of using bibliometric indicators. Because of the declining interest in indicators alone, this study was designed to repurpose bibliometrics to answer specific strategic questions. In this article we discuss the strategic and policy-based questions, the methodology we used in uncovering relevant information and conclusions we draw from the analyses we performed. The aim of this article is to inform a broader audience about the potential applications of bibliometric information to support a new form of research intelligence.MethodsIn this study we used a curated set of publications from the UMCs. We performed different bibliometric analyses and used bibliometric visualization tools to shed light on research focus, open science practices, collaboration, societal impact and scientific impact.ResultsThe analyses allowed us to visualize and contextualize the research focus of the UMCs as a whole, but also to show specific focus areas of each UMC. The UMCs are active in the full spectrum of biomedical research, and at the same time are very complementary to each other. Furthermore, we were able to show the development of open access of UMC publications over time, to support the national mission. Visualizing collaboration is a powerful way of showing both the international orientation and the regional and national engine function of UMCs in research. We were able to assess societal impact by looking at the different channels in which publications find their way to societally relevant sources such as news media, policy documents and guidelines. Finally, we assessed scientific impact and put this into an international perspective.ConclusionsResearch intelligence is able to transform bibliometric information by interpretation and annotation into highly relevant insights that can be used for several different strategic purposes and for research impact assessment in general.

Exploring nurses' role in guiding residents' workplace learning: A mixed-method study.

Understanding residents' workplace learning could be optimized by not only considering attending physicians' role but also the role of nurses. While previous studies described nurses' role during discrete activities (e.g. feedback), a more profound understanding of how nurses contribute to residents' learning remains warranted. Therefore, we used the educational concept of guidance and explored the extent to which residents' and nurses' perceptions align regarding nurses' guiding role and which reasons they provide for their perceptions. This mixed-method study was conducted at four Dutch university medical centres in 2021. We simultaneously collected quantitative and qualitative data from 103 residents and 401 nurses through a theory-informed questionnaire with a Likert-scale and open-ended questions. We analyzed quantitative data to explore respondents' perceptions of nurses' guiding role by using anova. The thematically analyzed qualitative open comments explored respondents' reasons for their perceptions. Nurses indicated to provide significantly more support (p = .01) and guidance on learning from patient care (p < .01) than perceived by residents. Moreover, nurses indicated that attending physicians did not always involve them in guiding residents, whereas residents perceived nurses were being involved (p < .001). Themes suggest that nurses and residents could be divided into two groups: (i) respondents who felt that guiding was inextricably linked to good interprofessional collaboration and patient care and (ii) respondents who saw the guiding role as limited and emphasised the distinct fields of expertise between nurses and physicians. Residents and nurses felt that nurses played an important role in guiding residents' workplace learning. However, some residents did not always perceive to be guided. To further capitalise on nurses' guiding role, we suggest that residents can be encouraged to engage in the learning opportunities nurses provide to achieve optimal team-based patient care.

Predicting pregnancy chances leading to term live birth in oligo/anovulatory women diagnosed with PCOS

Research questionWhich patient features predict the time to pregnancy (TTP) leading to term live birth in infertile women diagnosed with polycystic ovary syndrome (PCOS)? DesignProspective cohort follow-up study was completed, in which initial standardized phenotyping was conducted at two Dutch university medical centres from January 2004 to January 2014. Data were linked to the Netherlands Perinatal Registry to obtain pregnancy outcomes for each participant. All women underwent treatment according to a standardized protocol, starting with ovulation induction as first-line treatment. Predictors of pregnancies (leading to term live births) during the first year after PCOS diagnosis were evaluated. ResultsA total of 1779 consecutive women diagnosed with PCOS between January 2004 and January 2014 were included. In the first year following screening, 659 (37%) women with PCOS attained a pregnancy leading to term birth (≥37 weeks of gestational age). A higher chance of pregnancy was associated with race, smoking, body mass index (BMI), insulin, total testosterone and sex hormone-binding globulin (SHBG) concentrations (c-statistic = 0.59). ConclusionsPredictors of an increased chance of a live birth include White race, no current smoking, lower BMI, insulin and total testosterone concentrations, and higher SHBG concentrations. This study presents a nomogram to predict the chances of achieving a pregnancy (leading to a term live birth) within 1 year of treatment.

Impact of mucositis on oral bioavailability and systemic exposure of ciprofloxacin Gram-negative infection prophylaxis in patients with haematological malignancies.

Patients with haematological malignancies frequently endure neutropenia and gastrointestinal (GI)-mucositis after high-dose chemotherapy. In these patients, ciprofloxacin is used for Gram-negative infection prophylaxis. We investigate ciprofloxacin pharmacokinetics after oral administration in patients with haematological malignancies and explore the impact of GI-mucositis on oral bioavailability and clearance in order to assure adequate systemic exposure. Adult haematological patients from two Dutch University Medical Centres received 500 mg twice daily oral ciprofloxacin for Gram-negative prophylaxis. The ciprofloxacin plasma concentrations were collected at various timepoints after oral ciprofloxacin administration and at various days after completion of chemotherapy. Data obtained after oral and intravenous ciprofloxacin administration in 28 healthy volunteers without mucositis served as a control group (391 samples). For haematological patients the degree of GI-mucositis was assessed using the Daily Gut Score (DGS), plasma citrulline and albumin. Data were analysed by non-linear mixed-effects modelling. In total, 250 blood samples were collected in 47 patients with a wide variety of haematological malignancies between 0-30 days after start of chemotherapy. Mucositis was generally mild [DGS median (IQR) 1 (1-1) and citrulline 16 μmol/L (12-23)]. The time to Cmax was slower in haematological patients compared with healthy volunteers although no association with the degree of mucositis (defined as DGS or citrulline) could be identified. Ciprofloxacin bioavailability and clearance were 60% and 33.2 L/h, respectively. This study supports oral dosing of ciprofloxacin as Gram-negative infection prophylaxis in haematological patients with mild-to-moderate mucositis capable of oral intake.

Perceptions and behavior of clinical researchers and research support staff regarding data FAIRification

The FAIR Data Principles are being rapidly adopted by many research institutes and funders worldwide. This study aimed to assess the awareness and attitudes of clinical researchers and research support staff regarding data FAIRification. A questionnaire was distributed to researchers and support staff in six Dutch University Medical Centers and Electronic Data Capture platform users. 164 researchers and 21 support staff members completed the questionnaire. 62.8% of the researchers and 81.0% of the support staff are currently undertaking at least some effort to achieve any aspect of FAIR, 11.0% and 23.8%, respectively, address all aspects. Only 46.6% of the researchers add metadata to their datasets, 39.7% add metadata to data elements, and 35.9% deposit their data in a repository. 94.7% of the researchers are aware of the usefulness of their data being FAIR for others and 89.3% are, given the right resources and support, willing to FAIRify their data. Institutions and funders should, therefore, develop FAIRification training and tools and should (financially) support researchers and staff throughout the process.

Facilitators and barriers for the implementation of exercise are medicine in routine clinical care in Dutch university medical centres: a mixed methodology study on clinicians’ perceptions

ObjectivesDespite the many proven advantages of a physically active lifestyle in patient populations, prescription of exercise is currently not widely implemented in routine clinical practice. The aims of this study...

FAIRification Efforts of Clinical Researchers: The Current State of Affairs.

The FAIR Principles are supported by various initiatives in the biomedical community. However, little is known about the knowledge and efforts of individual clinical researchers regarding data FAIRification. We distributed an online questionnaire to researchers from six Dutch University Medical Centers, as well as researchers using an Electronic Data Capture platform, to gain insight into their understanding of and experience with data FAIRification. 164 researchers completed the questionnaire. 64.0% of them had heard of the FAIR Principles. 62.8% of the researchers spent some or a lot of effort to achieve any aspect of FAIR and 11.0% addressed all aspects. Most researchers were unaware of the Principles' emphasis on both human- and machine-readability, as their FAIRification efforts were primarily focused on achieving human-readability (93.9%), rather than machine-readability (31.2%). In order to make machine-readable, FAIR data a reality, researchers require proper training, support, and tools to help them understand the importance of data FAIRification and guide them through the FAIRification process.