Non-academic Teaching Hospitals Research Articles

Vaginal assisted NOTES hysterectomy in The Netherlands; A prospective cohort study

ObjectivesVaginal assisted Natural Orifice Transluminal Endoscopic Surgery (NOTES) combines the benefits of vaginal and endoscopic surgery. This study presents the results of the first vaginal assisted NOTES hysterectomies (VANH) in The Netherlands. Study designA prospective cohort study was performed in two non-academic teaching hospitals in The Netherlands. Data was collected from patients who underwent a VANH for benign indications between August 2019 and April 2023. Baseline characteristics and data of intra- and postoperative surgical outcomes were recorded and analysed. The VANHs were performed by four experienced vaginal and endoscopic gynaecological surgeons. ResultsA total of 200 patients underwent a VANH. Indications were dysfunctional menstrual bleeding (61 %; n = 122), abnormal cervical cytology (15.5 %; n = 31), abdominal pain (11.5 %; n = 23), post ablation/sterilization pain syndrome (3.5 %; n = 7), uterine fibroids (5.0 %; n = 10), atypical endometrial hyperplasia (2.5 %; n = 5) and Lynch or BRCA gene mutation carriers (1.0 %, n = 2). The mean surgical time was 61.4 min ( ± 22.8 min) with a mean blood loss of 88 mL ( ± 89 mL) and a mean uterine weight of 150 g ( ± 112 g). In 2.0 % (n = 4) of the cases a conversion was necessary. Same day discharge (SDD) was feasible in 80.2 % (n = 105) of the patients planned in day-care. In 2.0 % (n = 4) an intra-operative complication and in 9.0 % (n = 18) a post-operative complication occurred. ConclusionThis study shows vNOTES to be a safe and feasible surgical technique and can be safely implemented with appropriate patient selection and skilled surgeons. It highlights the importance of surgeon awareness of the challenges inherent in the initial stages of the implementation of a new surgical technique when performing their first vNOTES procedures. Additional randomized clinical trials are needed to show superiority of vNOTES compared to traditional surgery.

Essure removal surgery: Are preoperative transvaginal ultrasound and pelvic X-ray necessary?

ObjectiveThe objective of this study was twofold. (1) To investigate the predictive characteristics of transvaginal ultrasonography for hysteroscopy necessity in Essure removal surgery. (2) To investigate the additional predictive value of a preoperative pelvic radiograph to transvaginal ultrasonography for hysteroscopy necessity. Study DesignRetrospective cohort study, performed in an academic and a non-academic teaching hospital in the Netherlands. 71 women who underwent Essure removal surgery with a perioperative hysteroscopy and who had a preoperative pelvic X-ray and transvaginal ultrasound were included. Four experts first predicted hysteroscopy necessity based on transvaginal ultrasound description and secondly based on transvaginal ultrasound combined with the preoperative pelvic radiograph. Sensitivity, specificity, positive predictive value and negative predictive value of the predictive tests were calculated. ResultsBased on transvaginal ultrasound, the mean predictive characteristics for experts were: sensitivity 89.7% (range 66.7%–100%), specificity 37.4% (range 17.6%–67.7%), positive predictive value 18.8% (range 13.2%–29.5%) and negative predictive value 95.1% (range 86.1%–100%). After adding the pelvic radiograph to the transvaginal ultrasound descriptions, the results were: sensitivity 66.7% (range 53.3%–80%), specificity 72.6% (range 56%–97.3%), positive predictive value 23% (range 14.3%–26.9%) and negative predictive value 94.1 % (range 90.3%–98.4%). For three experts sensitivity decreased after adding the pelvic radiograph. For all experts specificity increased. ConclusionIt is difficult to preoperatively decide if the fourth marker of the Essure outer coil can be excised during hysteroscopy. The addition of pelvic radiography to transvaginal ultrasound is not beneficial. It is recommended to perform a hysteroscopy during Essure removal surgery.

The Patient Pathway for Men with Chronic Urinary Retention: Treatments, Complications, and Consequences

To explore the treatment options for chronic urinary retention (CUR) in men, including treatment-related complications and consequences. This retrospective cohort study included male patients diagnosed with a non-neurogenic, symptomatic and/or high-risk, CUR >150 mL in a large Dutch non-academic teaching hospital. Data for treatments, complications, and consequences (eg, diagnostics, additional treatments, and hospital contact) were recorded and incidence rate ratios (IRRs) were calculated. We enrolled 177 patients (median age, 77 years; range, 44-94) with a median follow-up of 68 months (range, 1-319) during which they had a median of 8 events (range, 1-51). Most patients initially received a urethral catheter (74%) and some form of catheterization as their final treatment (87%). Compared with non-surgical cases, catheterization was more likely to be stopped after de-obstructive prostate surgery (IRR, 4.18; P < 0.001). Urinary tract infection (IRR, 3.68; P < 0.001) and macroscopic hematuria (IRR, 5.35; P < 0.001) were more common with catheterization, but post-renal problems were more likely in patients with no catheterization (IRR, 25.36; P < 0.001). The lowest chance of complication was with clean intermittent catheterization, and complications were usually managed in outpatient (77%) or emergency (6%) departments, rather than by admission (17%). Most patients require catheterization for CUR, with clean intermittent catheterization preferred due to its comparatively lower complication risk. De-obstructive prostate surgery increases the chance of stopping catheterization and may be considered in suitable cases.

Mortality Reduction After a Preincision Safety Check Before Cardiac Surgery: Is It the Aorta?

The introduction and use of a preincision safety check were associated with lower mortality after mixed adult cardiac surgery; however, an explanatory mechanism is lacking. Stroke, one of the most severe complications after cardiac surgery, with high mortality, may be reduced by adapting the surgical handling of the ascending aorta. This study assessed the prevalence and predictors of this adaptation after a preincision safety check and the subsequent effect on outcome. A prospective, single-center, observational study comparing adaptation with no-adaptation. The primary outcome measure was 30-day mortality. Multivariate analyses were performed to determine independent predictors of adaptation. To study the effect of adaptation on outcome, a propensity score-matched cohort was constructed in a 1:3 intervention:control ratio. At Isala Zwolle (NL), a large, nonacademic teaching hospital. All consecutive cardiac surgery procedures from 2012 until 2015, including 4,752 surgeries. The adaptation of surgical handling of the ascending aorta. In 283 cardiac surgeries (5.9%), adaptation was indicated. The most important independent predictors for adaptation were extracardiac atherosclerosis, current smoking, and increasing age. In the propensity score-matched cohort consisting of 1,069 procedures, there were no significant differences in outcome. After correction for propensity score, the hazard ratio of adaptation for 30-day mortality was 1.8 (0.85-3.79). The adaptation of aortic surgical handling after a preincision safety check was necessary for 5.9% of cardiac surgeries, with extracardiac atherosclerosis as the strongest predictor. Outcome was not significantly different between patients with and without adaptation. Although promising, it remains unclear whether adaptation may fully explain mortality reduction after the use of a preincision safety check.

The patient pathway for overactive bladder management: A quantitative analysis.

We aimed to explore the pathways followed by patients with overactive bladder (OAB) from referral to the urologist to final treatment. This was a single-center, retrospective cohort study of female patients diagnosed with OAB in a large Dutch nonacademic teaching hospital. The number, sequence, and duration of treatment steps offered were analyzed, and the effectiveness, reasons for discontinuation, and possible case-mix variables influencing OAB treatment were studied. In total, 120 patients were enrolled and required a median of 2 steps (range, 1-6) of treatment over a median total duration of 28 weeks (range, 5-256). Treatment typically started with drug therapy, including antimuscarinics (38%; 95% CI, 30%-47%), antimuscarinics plus pelvic floor muscle therapy (21%; 95% CI, 15%-29%), or mirabegron (11%; 95% CI, 6%-18%). However, 52% of patients required further treatment, with botulinum toxin A (BoNT-A) injections being most effective (67%; 95% CI, 42%-85%), followed by antimuscarinics plus percutaneous tibial nerve stimulation (50%; 95% CI, 25%-75%), and antimuscarinics plus pelvic floor muscle therapy (36%; 95% CI, 21%-54%). Other therapies showed lower effectiveness. Common reasons for discontinuation were insufficient response and side effects. Overall, 22 patients were lost to follow-up. Most patients try at least two treatments before they experience satisfactory symptom relief, with treatment evaluations requiring time because therapeutic onsets differ by patient and treatment. Our data can help to manage expectations among urologists and patients when seeking treatment for OAB.

Supporting Women Undergoing IVF Treatment With Timely Patient Information Through an App: Randomized Controlled Trial.

BackgroundSince the introduction of assisted reproductive technologies in 1978, over 2 million in vitro fertilization (IVF) babies have been born worldwide. Patients play a vital role in the success of this treatment. They are required to take fertility medication (hormone injections) to activate the ovaries to produce a sufficient number of oocytes. Later, they need to take medication to increase the chance of the embryo surviving inside the uterus. Patients are educated during an intake consultation at the start of the treatment to minimize the emotional burden and reduce noncompliance. The consultation lasts about 30 to 45 minutes and covers all essential subjects. Even though ample time and energy is spent on patient education, patients still feel anxious, unknowledgeable, and unsupported. As such, electronic health utilizing a smartphone or tablet app can offer additional support, as it allows health care professionals to provide their patients with the correct information at the right time by using push notifications.ObjectiveThis randomized controlled trial aimed to evaluate the capacity of an app to support IVF patients throughout the different phases of their treatment and assess its effectiveness. The study's primary outcome was to determine the patients’ level of satisfaction with the information provided. The secondary outcomes included their level of knowledge, ability to administer the medication, overall experienced quality of the treatment, health care consumption, and app usage.MethodsThis study was performed at a specialized fertility clinic of the nonacademic teaching hospital Elisabeth-TweeSteden Ziekenhuis in Tilburg, the Netherlands. Patients who were scheduled for IVF or intracytoplasmic sperm injection treatments between April 2018 and August 2019 were invited to participate in a physician-blinded, randomized controlled trial.ResultsIn total, 54 patients participated (intervention group: n=29). Patients in the intervention group demonstrated a higher level of satisfaction on a 0 to 10 scale (mean 8.43, SD 1.03 vs mean 7.70, SD 0.66; P=.004). In addition, they were more knowledgeable about the different elements of the treatment on a 7 to 35 scale (mean 27.29, SD 2.94 vs mean 23.05, SD 2.76; P<.001). However, the difference disappeared over time. There were no differences between the two patient groups on the other outcomes. In total, 25 patients in the intervention group used the app 1425 times, an average of 57 times per patient.ConclusionsOur study demonstrates that, in comparison with standard patient education, using an app to provide patients with timely information increases their level of satisfaction. Furthermore, using the app leads to a higher level of knowledge about the steps and procedures of IVF treatment. Finally, the app’s usage statistics demonstrate patients’ informational needs and their willingness to use an electronic health application as part of their treatment.Trial RegistrationNetherlands Trial Register (NTR) 6959; https://www.trialregister.nl/trial/6959

Increased long-term mortality after open colorectal cancer surgery: A multicentre population-based study.

Unlike meta-analyses of randomized controlled trials, population-based studies in colorectal cancer (CRC) patients have shown a significant association between open surgery and increased 30- and 90-day mortality compared with laparoscopic surgery. Long-term mortality, however, is scarcely reported. This retrospective population-based study aimed to compare long-term mortality after open and laparoscopic surgery for CRC. The Dutch Colorectal Audit and the Dutch Cancer Centre registry were used to identify patients from three large nonacademic teaching hospitals who underwent curative resection for CRC between 2009 and 2018. Patients with relative contraindications for laparoscopic surgery (cT4 or pT4 tumours, distant metastasis requiring additional resection and emergency surgery) were excluded. Multivariable regression was used to assess the effect of laparoscopic surgery on long-term mortality with adjustment for gender, age, American Society of Anesthesiologists score, TNM stage, chemoradiation therapy and other confounders. We included 4531 patients, of whom 1298 (29%) underwent open surgery. The median follow-up was 43months (interquartile range 23-71months). Open surgery was associated with an increased risk of long-term mortality (adjusted hazard ratio 1.26, 95% confidence interval 1.10-1.45, p=0.001). Mixed-effects Cox regression with year of surgery as a random effect also showed an increased risk after open surgery (adjusted hazard ratio 1.33, 95% confidence interval 1.11-1.52, p=0.004). Open surgery seems to be associated with increased long-term mortality in the elective setting for CRC patients. A minimally invasive approach might improve long-term outcomes.

Imatinib in patients with severe COVID-19: a randomised, double-blind, placebo-controlled, clinical trial

BackgroundThe major complication of COVID-19 is hypoxaemic respiratory failure from capillary leak and alveolar oedema. Experimental and early clinical data suggest that the tyrosine-kinase inhibitor imatinib reverses pulmonary capillary leak.MethodsThis randomised, double-blind, placebo-controlled, clinical trial was done at 13 academic and non-academic teaching hospitals in the Netherlands. Hospitalised patients (aged ≥18 years) with COVID-19, as confirmed by an RT-PCR test for SARS-CoV-2, requiring supplemental oxygen to maintain a peripheral oxygen saturation of greater than 94% were eligible. Patients were excluded if they had severe pre-existing pulmonary disease, had pre-existing heart failure, had undergone active treatment of a haematological or non-haematological malignancy in the previous 12 months, had cytopenia, or were receiving concomitant treatment with medication known to strongly interact with imatinib. Patients were randomly assigned (1:1) to receive either oral imatinib, given as a loading dose of 800 mg on day 0 followed by 400 mg daily on days 1–9, or placebo. Randomisation was done with a computer-based clinical data management platform with variable block sizes (containing two, four, or six patients), stratified by study site. The primary outcome was time to discontinuation of mechanical ventilation and supplemental oxygen for more than 48 consecutive hours, while being alive during a 28-day period. Secondary outcomes included safety, mortality at 28 days, and the need for invasive mechanical ventilation. All efficacy and safety analyses were done in all randomised patients who had received at least one dose of study medication (modified intention-to-treat population). This study is registered with the EU Clinical Trials Register (EudraCT 2020–001236–10).FindingsBetween March 31, 2020, and Jan 4, 2021, 805 patients were screened, of whom 400 were eligible and randomly assigned to the imatinib group (n=204) or the placebo group (n=196). A total of 385 (96%) patients (median age 64 years [IQR 56–73]) received at least one dose of study medication and were included in the modified intention-to-treat population. Time to discontinuation of ventilation and supplemental oxygen for more than 48 h was not significantly different between the two groups (unadjusted hazard ratio [HR] 0·95 [95% CI 0·76–1·20]). At day 28, 15 (8%) of 197 patients had died in the imatinib group compared with 27 (14%) of 188 patients in the placebo group (unadjusted HR 0·51 [0·27–0·95]). After adjusting for baseline imbalances between the two groups (sex, obesity, diabetes, and cardiovascular disease) the HR for mortality was 0·52 (95% CI 0·26–1·05). The HR for mechanical ventilation in the imatinib group compared with the placebo group was 1·07 (0·63–1·80; p=0·81). The median duration of invasive mechanical ventilation was 7 days (IQR 3–13) in the imatinib group compared with 12 days (6–20) in the placebo group (p=0·0080). 91 (46%) of 197 patients in the imatinib group and 82 (44%) of 188 patients in the placebo group had at least one grade 3 or higher adverse event. The safety evaluation revealed no imatinib-associated adverse events.InterpretationThe study failed to meet its primary outcome, as imatinib did not reduce the time to discontinuation of ventilation and supplemental oxygen for more than 48 consecutive hours in patients with COVID-19 requiring supplemental oxygen. The observed effects on survival (although attenuated after adjustment for baseline imbalances) and duration of mechanical ventilation suggest that imatinib might confer clinical benefit in hospitalised patients with COVID-19, but further studies are required to validate these findings.FundingAmsterdam Medical Center Foundation, Nederlandse Organisatie voor Wetenschappelijk Onderzoek/ZonMW, and the European Union Innovative Medicines Initiative 2.

Comparison of the diagnostic yield of routine versus indicated flowmetry, ultrasound and cystoscopy in women with recurrent urinary tract infections

Introduction and hypothesisTo quantify and compare the outcomes of routine vs. urologist-requested diagnostic testing for recurrent urinary tract infections (rUTI).MethodsA retrospective cohort study of patients with rUTI referred to a large non-academic teaching hospital between 2016 and 2018 (Hospital A) and a university hospital between 2014 and 2016 (Hospital B). Electronic medical records were reviewed for baseline and diagnostic data. Women underwent the following assessments routinely: urinalysis, voiding diary, flowmetry in Hospital A and urinalysis, voiding diary, flowmetry, ultrasound, abdominal x-ray and cystoscopy in Hospital B. All other diagnostics were performed by indication in each hospital.ResultsWe included 295 women from Hospital A and 298 from Hospital B, among whom the mean age (57.6 years) and mean UTI frequency (5.6/year) were comparable, though more were postmenopausal in Hospital A. We identified abnormalities by flowmetry or post-void residual volumes in 134 patients (Hospital A: 79; Hospital B: 55), cystoscopy in 14 patients (Hospital A: 6; Hospital B: 8) and ultrasound in 42 patients (Hospital A: 16; Hospital B: 26), but these differences were not significant. Diagnostics altered treatment in 117 patients (e.g., pelvic floor muscle training, referral to another specialist, surgical intervention), mostly due to flowmetry and post-void residual volume measurement. The retrospective design and absence of follow-up data limit these results.ConclusionsThe routine use of cystoscopy and ultrasound in female patients with rUTIs should not be recommended as they yield few abnormalities and lead to additional costs.

Comparison of Mechanical Power During Adaptive Support Ventilation Versus Nonautomated Pressure-Controlled Ventilation-A Pilot Study.

The aim of this pilot study was to compare the amount of "mechanical power of ventilation" under adaptive support ventilation with nonautomated pressure-controlled ventilation. Single-center, observational prospective pilot study adjoining unitwide implementation of adaptive support ventilation in our department. The ICU of a nonacademic teaching hospital in the Netherlands. Twenty-four passive invasively ventilated critically ill patients expected to need of invasive ventilation beyond the following calendar day. In patients under adaptive support ventilation, only positive end-expiratory pressure and Fio2 were set by the caregivers-all other ventilator settings were under control of the ventilator; in patients under pressure-controlled ventilation, maximum airway pressure (Pmax), positive end-expiratory pressure, Fio2, and respiratory rate were set by the caregivers. Mechanical power of ventilation was calculated three times per day. Compared with pressure-controlled ventilation, mechanical power of ventilation with adaptive support ventilation was lower (15.1 [10.5-25.7] vs 22.9 [18.7-28.8] J/min; p = 0.04). Tidal volume was not different, but Pmax (p = 0.012) and respiratory rate (p = 0.012) were lower with adaptive support ventilation. This study suggests adaptive support ventilation may have benefits compared with pressure-controlled ventilation with respect to the mechanical power of ventilation transferred from the ventilator to the respiratory system in passive invasively ventilated critically ill patients. The difference in mechanical power of ventilation is not a result of a difference in tidal volume, but the reduction in applied pressures and respiratory rate. The findings of this observational pilot study need to be confirmed in a larger, preferably randomized clinical trial.

Increased long-term mortality after emergency colon resections.

Emergency surgery is a known predictor for 30-day mortality. However, its relationship with long-term mortality is still a matter of debate. The aim of this study was to analyse the effect of emergency surgery compared with elective surgery on long-term survival. Data from the Dutch Colorectal Audit and the Dutch Cancer Centre registry of a large nonacademic teaching hospital were used to analyse outcomes of patients who underwent surgery for colon cancer from 2009 until 2017. Univariable and multivariable Cox regression were used to assess the effect of emergency surgery on long-term mortality with adjustment for patient, tumour and treatment characteristics. A total of 1139 patients with a median follow-up of 40months (interquartile range 23-65months) were included. Emergency surgery was performed in 158 patients (14%). The 5-year survival after emergency surgery was 46% compared with 72% after elective surgery. After adjusting for baseline differences there was an independent and significant association between emergency surgery and increased long-term mortality (hazard ratio 1.79, 95% CI 1.28-2.51, P=0.001). Emergency surgery for colon cancer seems to lead to a significantly increased risk of long-term mortality compared with elective surgery. Detection and treatment of early symptoms that can lead to emergency surgery might be the way forward.

Using eHealth to Support COVID-19 Education, Self-Assessment, and Symptom Monitoring in the Netherlands: Observational Study.

BackgroundThe coronavirus disease (COVID-19) situation demands a lot from citizens, health care providers, and governmental institutions. Citizens need to cope with guidelines on social interaction, work, home isolation, and symptom recognition. Additionally, health care providers and policy makers have to cope with unprecedented and unpredictable pressure on the health care system they need to manage. By providing citizens with an app, they always have access to the latest information and can assess their own health. This data could be used to support policy makers and health care providers to get valuable insights in the regional distribution of infection load and health care consumption.ObjectiveThe aim of this observational study is to assess people’s use of an app to support them with COVID-19 education, self-assessment, and monitoring of their own health for a 7-day period. In addition, we aim to assess the usability of this data for health care providers and policy makers by applying it to an interactive map and combining it with hospital data. The secondary outcomes of the study were user’s satisfaction with the information provided in the app, perceived usefulness of the app, health care providers they contacted, and the follow-up actions from this contact.MethodsThis observational cohort study was carried out at the nonacademic teaching hospital “Elisabeth Twee Steden” (ETZ) in Tilburg, Netherlands. From April 1, 2020, onwards ETZ offered the COVID-19 education, self-assessment, and symptom tracking diary to their already existing app for patient education and monitoring.ResultsBetween April 1 and April 20, 2020, a total of 6194 people downloaded the app. The self-assessment functionality was used abundantly to check one’s health status. In total, 5104 people responded to the question about severe symptoms, from which 242 indicated to suffer from severe symptoms. A total of 4929 people responded to the question about mild symptoms, from which 3248 indicated to suffer from these. The data was successfully applied to an interactive map, displaying user demographics and health status. Furthermore, the data was linked to clinical data. App users were satisfied with the information in the app and appreciated the symptom diary functionality. In total, 102 users reached out to a health care provider, leading to 91 contacts.ConclusionsOur study demonstrated the successful implementation and use of an app with COVID-19 education, self-assessment, and a 7-day symptom diary. Data collected with the app were successfully applied to an interactive map. In addition, we were able to link the data to COVID-19 screening results from the hospital’s microbiology laboratory. This data could be used to support policy makers and health care providers to get valuable insights in the regional distribution of infection load and health care consumption.Trial RegistrationNetherlands Trial Register NL8501; https://www.trialregister.nl/trial/8501

The development of the evidence-based SDMMCC intervention to improve shared decision making in geriatric outpatients: the DICO study

BackgroundShared decision making (SDM) contributes to personalized decisions that fit the personal preferences of patients when choosing a treatment for a condition. However, older adults frequently face multiple chronic conditions (MCC). Therefore, implementing SDM requires special features. The aim of this paper is to describe the development of an intervention to improve SDM in older adults with MCC.MethodsFollowing the Medical Research Council framework for developing complex interventions, the SDMMCC intervention was developed step-wise. Based on a literature review and empirical research in a co-creation process with end users, we developed training for geriatricians and a preparatory tool for older patients with MCC and informal caregivers. After assessing feasibility, the intervention was implemented in a pilot study (N = 108) in two outpatient geriatric clinics of an academic and a non-academic teaching hospital in Amsterdam, the Netherlands.ResultsKey elements of the training for geriatricians include developing skills to involve older adults with MCC and informal caregivers in SDM and following the six-step ‘Dynamic model for SDM with frail older patients’, as well as learning how to explore personal goals related to quality of life and how to form a partnership with the patient and the informal caregiver. Key elements of the preparatory tool for patients include an explicit invitation to participate in SDM, nomination that the patient’s own knowledge is valuable, invitation to form a partnership with the geriatrician, encouragement to share information about daily and social functioning and exploration of possible goals. Furthermore, the invitation of informal caregivers to share their concerns was also a key element.ConclusionsThrough a process of co-creation, both training for geriatricians and a preparatory tool for older adults and their informal caregivers were developed, tailored to the needs of the end users and based on the ‘Dynamic model of SDM with frail older patients’.

Swiss chocolate and free beverages to increase the motivation for scientific work amongst residents: a prospective interventional study in a non-academic teaching hospital in Switzerland

BackgroundThe success of a clinical trial depends on its recruitment of eligible patients; therefore, the recruitment period requires special attention. We hypothesized that with a new approach focused on continuous information and gratification, resident motivation to participate in scientific work will increase and recruitment rates will improve.MethodsOur new recruitment approach was applied to the recruitment phase of two prospective randomized trials (registered at the German Clinical Trials Register). Randomization of these trials was performed first using blinded envelopes; later a soft drink machine was used as the delivery tool of randomization as a lighthearted motivation to join scientific work and to reward the resident with free soft drinks for each recruitment. Residents were informed about the trial via a lecture and by mail. To increase interest everyone received Swiss chocolate. With a multiple choice survey we investigated the success of our actions at 6 and 12 months. Recruitment rates of the trials were evaluated and associated with the motivational approaches.ResultsOur residents rated their awareness of the trials with median 9 (IQR 7;9) during the first and 8 (IQR 5;9) during the second survey and their interest in scientific work with median 7 (IQR 4;8) and 6 (IQR 5;8). The percentage of residents feeling highly motivated improved from 58% to 70%. The recruitment rates stayed stably high over time with 73% and 72% in trial 1 and 90% and 85% in trial 2; 24% of residents stated their motivation could be increased by gratifications.ConclusionsAfter implementation of our new recruitment approach we found positively motivated residents and high recruitment rates in the corresponding trials. We propose this procedure may help to ensure the successful initiation of clinical trials. Larger studies testing this approach are warranted.

Hospital Utilization and Costs in Older Patients with Advanced Chronic Kidney Disease Choosing Conservative Care or Dialysis: A Retrospective Cohort Study

Background: Nondialytic conservative care has been recognized as a viable alternative to chronic dialysis in older patients with end-stage kidney disease, but little is known about its consequences on hospital utilization and costs. Methods: We performed a retrospective cohort study to compare outpatient and inpatient hospital utilization, place of death, and hospital costs in patients aged ≥70 years old who chose conservative care (n = 100) or dialysis (n = 162) after shared decision making in a nonacademic teaching hospital between 2008 and 2016. Results: Patients who chose conservative care were older than patients who chose dialysis (82.5 vs. 76.3 years). Comorbidity did not differ between the 2 patient groups. The incidence rates of outpatient visits per year were 7.1 in patients who chose conservative care and 10.7 in patients who chose dialysis (incidence rate ratio 0.67, 95% CI 0.55–0.81). The incidence rates of in-hospital days per year were, respectively, 6.0 and 9.8 (incidence rate ratio 0.50, 95% CI 0.29–0.88). Also in the final month of life, patients on conservative care had less outpatient visits, were less frequently hospitalized, and died less frequently in hospital than the dialysis patient group. The cost rates per year, measured from original treatment decision, were EUR 5,859 in conservative care patients and EUR 28,354 in patients who chose dialysis comprising both the predialysis and dialysis period (cost rate ratio 0.42, 95% CI 0.27–0.65). Patients who chose dialysis had higher costs on dialysis sessions, outpatient care, inpatient care, laboratory tests, and medical imaging. Conclusions: Patients who decided to forego dialysis and chose conservative care had less outpatient and inpatient hospital utilization than patients who chose dialysis, including less intensive hospital utilization near the end of life. Both overall and nondialysis-related costs were lower in patients on a conservative care pathway.

Early onset sepsis calculator implementation is associated with reduced healthcare utilization and financial costs in late preterm and term newborns

The neonatal early onset sepsis (EOS) calculator is a novel tool for antibiotic stewardship in newborns, associated with a reduction of empiric antibiotic treatment for suspected EOS. We studied if implementation of the EOS calculator results in less healthcare utilization and lower financial costs of suspected EOS. For this, we compared two single-year cohorts of hospitalizations within 3 days after birth in a Dutch nonacademic teaching hospital, before and after implementation of the EOS calculator. All admitted newborns born at or after 35 weeks of gestation were eligible for inclusion. We analyzed data from 881 newborns pre-implementation and 827 newborns post-implementation. We found significant reductions in EOS-related laboratory tests performed and antibiotic days, associated with implementation of the EOS calculator. Mean length of hospital stay was shorter, and EOS-related financial costs were lower after implementation among term, but not among preterm newborns.Conclusion: In addition to the well-known positive impact on antibiotic stewardship, implementation of the EOS calculator is also clearly associated with reductions in healthcare utilization related to suspected EOS in late preterm and term newborns and with a reduction in associated financial costs among those born term.What is Known:• The early-onset sepsis (EOS) calculator is a novel tool for antibiotic stewardship in newborns, associated with a reduction in empiric antibiotic treatment for suspected EOS.What is New:• In newborns at risk for EOS, EOS calculator implementation is associated with a significant reduction in laboratory investigations related to suspected EOS and significantly shorter stay in those born term.• EOS calculator implementation in term newborns is associated with a mean reduction of €207 in costs for EOS-related care per admitted newborn.

Protamine/heparin 0.6 ratio in cardiac surgery

Introduction In cardiac surgery, haemostasis is key.¹ Adequate heparinization is necessary to attain perioperative prevention of thrombus formation during cardio-pulmonary bypass (CPB).² To counteract the heparin effect, protamine hydrochloride is administered.³ The main objective of this retrospective study was to analyse the effect of a protamine/heparin 0.5-0.7/1 ratio, which was implemented in our hospital as of May 2017, versus a ratio > 0.7-1.0/1 on postoperative blood loss and transfusion rate after cardiac surgery. Methods This retrospective study was conducted at a non-academic teaching hospital and based on a prospectively collected database. All patients that underwent cardiac surgery requiring CPB between May 2016 and May 2018 were included. The main outcome variables 12h postoperative total chest tube production and the total amount of blood and blood component transfusions were compared between groups by the use of the Chi-square and Mann-Whitney U test. Results A total of 1939 patients were included. We compared 1150 patients with a 0.5-0.7/1-protamine/heparin ratio versus 789 patients with > 0.7/1-protamine/heparin ratio (Table 1). Pre-operative coagulation values were within the normal range. The median 12h postoperative blood loss was 230 mL in the 0.5-0.7-ratio group versus 260 mL in the >0.7 ratio group (p The amount of patients that received blood component transfusion (composite endpoint of fresh frozen plasma (FFP), packed red blood cells (PRBC), fibrinogen concentrate (FC), platelet concentrate (PC) and prothrombin complex (PCC)) was significantly different. In the 0.5-0.7-protamine/heparin-ratio group 71.3% of the patients were transfusion free, compared to 62,5% of transfusion free patients in the high ratio group (p Discussion A average 0.6-protamine/heparin-ratio after CPB in cardiac surgery is associated with a reduced 12h postoperative blood loss and a reduced amount of patients that received blood or blood components transfusion, compared to > 0.7-protamine/heparin ratio.

The FUTURE Trial: A Multicenter Randomised Controlled Trial on Target Biopsy Techniques Based on Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer in Patients with Prior Negative Biopsies

BackgroundGuidelines advise multiparametric magnetic resonance imaging (mpMRI) before repeat biopsy in patients with negative systematic biopsy (SB) and a suspicion of prostate cancer (PCa), enabling MRI targeted biopsy (TB). No consensus exists regarding which of the three available techniques of TB should be preferred. ObjectiveTo compare detection rates of overall PCa and clinically significant PCa (csPCa) for the three MRI-based TB techniques. Design, setting, and participantsMulticenter randomised controlled trial, including 665 men with prior negative SB and a persistent suspicion of PCa, conducted between 2014 and 2017 in two nonacademic teaching hospitals and an academic hospital. InterventionAll patients underwent 3-T mpMRI evaluated with Prostate Imaging Reporting and Data System (PIRADS) version 2. If imaging demonstrated PIRADS ≥3 lesions, patients were randomised 1:1:1 for one TB technique: MRI-transrectal ultrasound (TRUS) fusion TB (FUS-TB), cognitive registration TRUS TB (COG-TB), or in-bore MRI TB (MRI-TB). Outcome measurements and statistical analysisPrimary (overall PCa detection) and secondary (csPCa detection [Gleason score ≥3+4]) outcomes were compared using Pearson chi-square test. Results and limitationsOn mpMRI, 234/665 (35%) patients had PIRADS ≥3 lesions and underwent TB. There were no significant differences in the detection rates of overall PCa (FUS-TB 49%, COG-TB 44%, MRI-TB 55%, p=0.4). PCa detection rate differences were −5% between FUS-TB and MRI-TB (p=0.5, 95% confidence interval [CI] −21% to 11%), 6% between FUS-TB and COG-TB (p=0.5, 95% CI −10% to 21%), and −11% between COG-TB and MRI-TB (p=0.17, 95% CI −26% to 5%). There were no significant differences in the detection rates of csPCa (FUS-TB 34%, COG-TB 33%, MRI-TB 33%, p>0.9). Differences in csPCa detection rates were 2% between FUS-TB and MRI-TB (p=0.8, 95% CI −13% to 16%), 1% between FUS-TB and COG-TB (p>0.9, 95% CI −14% to 16%), and 1% between COG-TB and MRI-TB (p>0.9, 95% CI −14% to 16%). The main study limitation was a low rate of PIRADS ≥3 lesions on mpMRI, causing underpowering for primary outcome. ConclusionsWe found no significant differences in the detection rates of (cs)PCa among the three MRI-based TB techniques. Patient summaryIn this study, we compared the detection rates of (aggressive) prostate cancer among men with prior negative biopsies and a persistent suspicion of cancer using three different techniques of targeted biopsy based on magnetic resonance imaging. We found no significant differences in the detection rates of (aggressive) prostate cancer among the three techniques.

Insight in Information Provision Prior to Obtaining Surgical Informed Consent-by Audiotaping Outpatient Consultations.

Literature suggests that patient-informing process prior to obtaining surgical informed consent (SIC) does not function well. This study aimed to provide insight into the current practice of SIC in the Netherlands. This is a prospective, observational, and multicenter study, conducted in one academic and two non-academic teaching hospitals in the Netherlands. Audio recordings were made during outpatient consultations with patients presenting with Dupuytren Disease. The recorded informing process was scored according to a checklist. Written documentation of the SIC process in the patient's chart was compared to these scored checklists. Time spent on SIC during the consultations was also recorded. A total of 41 outpatient consultations were included in the study. Consultations were conducted by 25 plastic surgeons and their residents. Average time spent on SIC was 55.6% of the total consultation time. Considerable variation was observed concerning the amount and type of information given and discussed. In 59% of the consultations, discrepancies were observed between written documentation of consultations and audio recordings. Information on treatment risks, the postoperative period, and the operating surgeon was addressed the least. Despite a relatively large part of the consultation time being spent on SIC, patients received scarce information concerning treatment risks, postoperative period, and who their operating surgeon would be. Discrepancies were observed between the written documentation of SIC and information recorded on the audio recordings. This occurred predominantly in one hospital that used a pre-made list of 'discussed information' in its digital patient chart.

Value-based evaluation of dialysis versus conservative care in older patients with advanced chronic kidney disease: a cohort study

BackgroundConservative care is argued to be a reasonable treatment alternative for dialysis in older patients with advanced chronic kidney disease (CKD). However, comparisons are scarce and generally focus on survival only. Comparative data on more patient-relevant outcomes are needed to truly foster shared decision-making on an individual level, and cost comparison is needed to assess value of care.MethodsWe conducted a retrospective observational single-center cohort study in 366 patients aged ≥70 years with advanced CKD, who chose dialysis (n = 240) or conservative care (n = 126) after careful counselling by a multidisciplinary team in a non-academic teaching hospital in The Netherlands. Using a value-based health care approach (value = outcomes/cost): survival, health-related quality of life—cross-sectionally assessed with the Kidney Disease Quality of Life Short Form™—treatment burden, and treatment costs were evaluated.ResultsThe overall survival benefit of patients on a dialysis pathway compared with patients on conservative care diminished or lost significance in patients aged ≥80 years or with severe comorbidity. There were no differences between patients managed conservatively and dialysis patients on physical and mental health summary scores (all P > 0.1). Patients on conservative care had 352.7 hospital free days per year versus 282.7 in patients on a dialysis pathway, calculated from treatment decision (adjusted incidence rate ratio: 1.15, 95% confidence interval: 1.09 to 1.21, P < 0.001). Annual treatment costs were lower in patients on conservative care (adjusted cost ratio: 0.43, 95% confidence interval: 0.28 to 0.67, P < 0.001).ConclusionsIn this study, conservative care is shown to be a viable treatment option in older patients with advanced CKD, particularly in the oldest old and those with severe comorbidity. By achieving similar outcomes at lower treatment burden and treatment costs, value was generated for older patients choosing conservative care and society.