Preoperative Weight Gain Is Not Related to Lower Postoperative Weight Loss, But to Lower Total Weight Loss up to 3 Years After Bariatric-Metabolic Surgery.

INTRODUCTION: Weight loss prior to bariatric-metabolic surgery (BMS) is recommended in most bariatric centers. However, there is limited high-quality evidence to support mandatory preoperative weight loss. In this study, we will evaluate whether weight gain prior to primary BMS is related to lower postoperative weight loss. METHODS: A retrospective analysis of prospectively collected data was performed. Preoperative weight loss (weight loss from start of program to day of surgery), postoperative weight loss (weight loss from day of surgery to follow-up), and total weight loss (weight loss from start of program to follow-up) were calculated. Five groups were defined based on patients' preoperative weight change: preoperative weight loss of >5 kg (group I), 3-5 kg (group II), 1-3 kg (group III), preoperative stable weight (group IV), and preoperative weight gain >1 kg (group V). Linear mixed models were used to compare the postoperative weight loss between group V and the other four groups (I-IV). RESULTS: A total of 1928 patients were included. Mean age was 44 years, 78.6% were female, and preoperative BMI was 43.7 kg/m2. Analysis showed significantly higher postoperative weight loss in group V, compared to all other groups at 12, 24, and 36 months follow-up. Up to three years follow-up, highest total weight loss was observed in group I. CONCLUSION: Weight gain before surgery should not be a reason to withhold a bariatric-metabolic operation. However, patients with higher preoperative weight loss have higher total weight loss. Therefore, preoperative weight loss should be encouraged prior to bariatric surgery.

A Cost Overview of Minimally Invasive Total Mesorectal Excision in Rectal Cancer Patients: A Population-based Cohort in Experienced Centres.

Background: Total mesorectal excision has been the gold standard for the operative management of rectal cancer. The most frequently used minimally invasive techniques for surgical resection of rectal cancer are laparoscopic, robot-assisted, and transanal total mesorectal excision. As studies comparing the costs of the techniques are lacking, this study aims to provide a cost overview. Method: This retrospective cohort study included patients who underwent total mesorectal resection between 2015 and 2017 at 11 dedicated centers, which completed the learning curve of the specific technique. The primary outcome was total in-hospital costs of each technique up to 30 days after surgery including all major surgical cost drivers, while taking into account different team approaches in the transanal approach. Secondary outcomes were hospitalization and complication rates. Statistical analysis was performed using multivariable linear regression analysis. Results: In total, 949 patients were included, consisting of 446 laparoscopic (47%), 306 (32%) robot-assisted, and 197 (21%) transanal total mesorectal excisions. Total costs were significantly higher for transanal and robot-assisted techniques compared to the laparoscopic technique, with median (interquartile range) for laparoscopic, robot-assisted, and transanal at €10,556 (8,642;13,829), €12,918 (11,196;16,223), and € 13,052 (11,330;16,358), respectively (P < 0.001). Also, the one-team transanal approach showed significant higher operation time and higher costs compared to the two-team approach. Length of stay and postoperative complications did not differ between groups. Conclusion: Transanal and robot-assisted approaches show higher costs during 30-day follow-up compared to laparoscopy with comparable short-term clinical outcomes. Two-team transanal approach is associated with lower total costs compared to the transanal one-team approach.

How safe is the treatment of pregnant women with fear of childbirth using eye movement desensitization and reprocessing therapy? Obstetric outcomes of a multi-center randomized controlled trial.

INTRODUCTION: Pregnant women with fear of childbirth display an elevated risk of a negative delivery experience, birth-related post-traumatic stress disorder, and adverse perinatal outcomes such as preterm birth, low birthweight, and postpartum depression. One of the therapies used to treat fear of childbirth is eye movement desensitization and reprocessing (EMDR) therapy. The purpose of the present study was to determine the obstetric safety and effectiveness of EMDR therapy applied to pregnant women with fear of childbirth. MATERIAL AND METHODS: A randomized controlled trial (the OptiMUM-study) was conducted in two teaching hospitals and five community midwifery practices in the Netherlands (www.trialregister.nl, NTR5122). Pregnant women (n = 141) with a gestational age between 8 and 20 weeks and suffering from fear of childbirth (i.e. sum score on the Wijma Delivery Expectations Questionnaire ≥85) were randomly allocated to either EMDR therapy (n = 70) or care-as-usual (CAU) (n = 71). Outcomes were maternal and neonatal outcomes and patient satisfaction with pregnancy and childbirth. RESULTS: A high percentage of cesarean sections (37.2%) were performed, which did not differ between groups. However, women in the EMDR therapy group proved seven times less likely to request an induction of labor without medical indication than women in the CAU group. There were no other significant differences between the groups in maternal or neonatal outcomes, satisfaction, or childbirth experience. CONCLUSIONS: EMDR therapy during pregnancy does not adversely affect pregnancy or the fetus. Therefore, therapists should not be reluctant to treat pregnant women with fear of childbirth using EMDR therapy.

Twenty-four hours stay after colorectal surgery: a systematic review

Introduction: The introduction of Enhanced Recovery After Surgery led to increasing twenty-four hours discharge pathways, for example in laparoscopic cholecystectomy and bariatric surgery. However, implementation in colorectal surgery still must set off. This systematic review assesses safety and feasibility of twenty-four hours discharge in colorectal surgery in terms of readmission and complications in current literature. Secondary outcome was identification of factors associated with success of twenty-four hours discharge. Methods: Pubmed and EMBASE databases were searched to identify studies investigating twenty-four hours discharge in colorectal surgery, without restriction of study type. Search strategy included keywords relating to ambulatory management and colorectal surgery. Studies were scored according to MINORS score. Results: Thirteen studies were included in this systematic review, consisting of six prospective and seven retrospective studies. Number of participants of the included prospective studies ranged from 5 to 157. Median success of discharge was 96% in the twenty-four hours discharge group. All prospective studies showed similar readmission and complication rates between twenty-four hours discharge and conventional postoperative management. Factors associated with success of twenty-four hours discharge were low ASA classification, younger age, minimally invasive approach, and relatively shorter operation time. Conclusions: Twenty-four hours discharge in colorectal surgery seems feasible and safe, based on retro- and prospective studies. Careful selection of patients and establishment of a clear and adequate protocol are key items to assure safety and feasibility. Results should be interpreted with caution, due to heterogeneity. To confirm results, an adequately powered prospective randomized study is needed. (AU)

Use of ileostomy versus colostomy as a bridge to surgery in left-sided obstructive colon cancer: retrospective cohort study.

BACKGROUND: Colorectal cancer causes the majority of large bowel obstructions and surgical resection remains the gold standard for curative treatment. There is evidence that a deviating stoma as a bridge to surgery can reduce postoperative mortality rate; however, the optimal stoma type is unclear. The aim of this study was to compare outcomes between ileostomy and colostomy as a bridge to surgery in left-sided obstructive colon cancer. METHODS: This was a national, retrospective population-based cohort study with 75 contributing hospitals. Patients with radiological left-sided obstructive colon cancer between 2009 and 2016, where a deviating stoma was used as a bridge to surgery, were included. Exclusion criteria were palliative treatment intent, perforation at presentation, emergency resection, and multivisceral resection. RESULTS: A total of 321 patients underwent a deviating stoma; 41 (12.7 per cent) ileostomies and 280 (87.2 per cent) colostomies. The ileostomy group had longer length of stay (median 13 (interquartile range (i.q.r.) 10-16) versus 9 (i.q.r. 6-14) days, P = 0.003) and more nutritional support during the bridging interval. Both groups showed similar complication rates in the bridging interval and after primary resection, including anastomotic leakage. Stoma reversal during resection was more common in the colostomy group (9 (22.0 per cent) versus 129 (46.1 per cent) for ileostomy and colostomy respectively, P = 0.006). CONCLUSION: This study demonstrated that patients having a colostomy as a bridge to surgery in left-sided obstructive colon cancer had a shorter length of stay and lower need for nutritional support. No difference in postoperative complications were found.

The Intervention Selection Toolbox to improve patient-relevant outcomes: an implementation and qualitative evaluation study in colorectal cancer surgery.

BACKGROUND: The concept of value-based healthcare is being used worldwide to improve healthcare. The Intervention Selection Toolbox was developed to bridge the gap of value-based healthcare, between insights in outcomes and actual quality improvement initiatives. In this study we aimed to evaluate the use of the Intervention Selection Toolbox in daily practice of a quality improvement team in a hospital setting. METHODS: A methodological triangulation design was used. The Intervention Selection Toolbox was used by a multidisciplinary quality improvement team for colorectal cancer care in a large teaching hospital. In-depth semi-structured interviews, focusing on the key elements of process evaluation, were conducted after implementation with representatives of the quality improvement team to evaluate the use of the Intervention Selection Toolbox. Quantitative data regarding improvement initiatives and degree of implementation was also collected. RESULTS: The use of the Intervention Selection Toolbox initially resulted in 80 potential quality improvement initiatives. Eventually, two high potential improvement initiatives were selected. Some components of the toolbox were successfully implemented in daily practice, although 'standard monitoring' and 'causal chain analysis' proved more difficult to implement. Qualitative analysis was performed with ten members of the multidisciplinary team before thematic saturation occurred. Interviewed members had a wide range in characteristics: age 28-61 years, clinical experience 6-38 years and educational attainment from vocational program to academic doctorate. The Interviews showed added value in the use of the toolbox, but identified time and organizational management as restricting factors. CONCLUSIONS: The Intervention Selection Toolbox is useful to systematically identify improvement initiatives with impact on health outcomes that matter to patients. However, before implementation organizational structure should be optimized to maximize success and efficiency on integration of the Intervention Selection Toolbox.

SPONGE-assisted versus Trendelenburg position surgery in laparoscopic sigmoid and rectal cancer surgery (SPONGE trial): randomized clinical trial.

BACKGROUND: In minimally invasive surgery of the sigmoid colon and rectum a retractor sponge has been introduced as an alternative to the Trendelenburg position. This randomized clinical trial (RCT) compared postoperative duration of hospital stay and perioperative outcomes in patients with sigmoid or rectal cancer undergoing sponge-assisted versus Trendelenburg position surgery. METHODS: The SPONGE trial is a single-centre RCT nested within the Dutch nationwide prospective observational cohort of patients with colorectal cancer, and follows the Trials within Cohorts (TwiCs) design. Patients with sigmoid or rectal cancer undergoing elective laparoscopic or robotic surgery were randomized to either sponge-assisted or Trendelenburg surgery on a 1:1 basis using block randomization. Duration of postoperative hospital stay was the primary outcome and was compared using the Mann-Whitney U test. Secondary endpoints included the proportion of complications, readmissions, or mortality versus the χ2 test in intention-to-treat and per-protocol analyses. This trial was not blinded for patients in the intervention arm or physicians. RESULTS: Between November 2015 and June 2021, 82 patients were randomized to sponge-assisted surgery and 81 to Trendelenburg surgery. After post-randomization exclusion, 150 patients remained for analyses (75 patients per arm). There was no statistically significant difference in median duration of hospital stay (5 days versus 4 days, respectively; P = 0.06), 30-day postoperative complications (30 per cent versus 31 per cent; P = 1.00), readmission rate (8 per cent versus 15 per cent; P = 0.30), or mortality (0 per cent versus 1 per cent, P = 1.00). The per-protocol analysis showed similar results. No adverse device events were seen. CONCLUSION: Sponge-assisted laparoscopic/robotic surgery does not reduce the duration of hospital stay, or perioperative morbidity or mortality. TRIAL REGISTRATION: NCT02574013 (http://www.clinicaltrials.gov).

Development and External Validation of a Novel Nomogram to Predict Side-specific Extraprostatic Extension in Patients with Prostate Cancer Undergoing Radical Prostatectomy.

BACKGROUND: Prediction of side-specific extraprostatic extension (EPE) is crucial in selecting patients for nerve-sparing radical prostatectomy (RP). OBJECTIVE: To develop and externally validate nomograms including multiparametric magnetic resonance imaging (mpMRI) information to predict side-specific EPE. DESIGN, SETTING, AND PARTICIPANTS: A retrospective analysis of 1870 consecutive prostate cancer patients who underwent robot-assisted RP from 2014 to 2018 at three institutions. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Four multivariable logistic regression models were established, including combinations of patient-based and side-specific variables: prostate-specific antigen (PSA) density, highest ipsilateral International Society of Urological Pathology (ISUP) biopsy grade, ipsilateral percentage of positive cores on systematic biopsy, and side-specific clinical stage assessed by both digital rectal examination and mpMRI. Discrimination (area under the curve [AUC]), calibration, and net benefit of these models were assessed in the development cohort and two external validation cohorts. RESULTS AND LIMITATIONS: On external validation, AUCs of the four models ranged from 0.80 (95% confidence interval [CI] 0.68-0.88) to 0.83 (95% CI 0.72-0.90) in cohort 1 and from 0.77 (95% CI 0.62-0.87) to 0.78 (95% CI 0.64-0.88) in cohort 2. The three models including mpMRI staging information resulted in relatively higher AUCs compared with the model without mpMRI information. No major differences between the four models regarding net benefit were established. The model based on PSA density, ISUP grade, and mpMRI T stage was superior in terms of calibration. Using this model with a cut-off of 20%, 1980/2908 (68%) prostatic lobes without EPE would be found eligible for nerve sparing, whereas non-nerve sparing would be advised in 642/832 (77%) lobes with EPE. CONCLUSIONS: Our analysis resulted in a simple and robust nomogram for the prediction of side-specific EPE, which should be used to select patients for nerve-sparing RP. PATIENT SUMMARY: We developed a prediction model that can be used to assess accurately the likelihood of tumour extension outside the prostate. This tool can guide patient selection for safe nerve-sparing surgery.

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

AIM: 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. METHOD: 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. RESULTS: We included 4531 patients, of whom 1298 (29%) underwent open surgery. The median follow-up was 43 months (interquartile range 23-71 months). 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). CONCLUSION: 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.

External validation of the Memorial Sloan Kettering Cancer Centre and Briganti nomograms for the prediction of lymph node involvement of prostate cancer using clinical stage assessed by magnetic resonance imaging.

OBJECTIVES: To evaluate the impact of using clinical stage assessed by multiparametric magnetic resonance imaging (mpMRI) on the performance of two established nomograms for the prediction of pelvic lymph node involvement (LNI) in patients with prostate cancer. PATIENTS AND METHODS: Patients undergoing robot-assisted extended pelvic lymph node dissection (ePLND) from 2015 to 2019 at three teaching hospitals were retrospectively evaluated. Risk of LNI was calculated four times for each patient, using clinical tumour stage (T-stage) assessed by digital rectal examination (DRE) and by mpMRI, in the Memorial Sloan Kettering Cancer Centre (MSKCC; 2018) and Briganti (2012) nomograms. Discrimination (area under the curve [AUC]), calibration, and the net benefit of these four strategies were assessed and compared. RESULTS: A total of 1062 patients were included, of whom 301 (28%) had histologically proven LNI. Using DRE T-stage resulted in AUCs of 0.71 (95% confidence interval [CI] 0.70-0.72) for the MSKCC and 0.73 (95% CI 0.72-0.74) for the Briganti nomogram. Using mpMRI T-stage, the AUCs were 0.72 (95% CI 0.71-0.73) for the MSKCC and 0.75 (95% CI 0.74-0.76) for the Briganti nomogram. mpMRI T-stage resulted in equivalent calibration compared with DRE T-stage. Combined use of mpMRI T-stage and the Briganti 2012 nomogram was shown to be superior in terms of AUC, calibration, and net benefit. Use of mpMRI T-stage led to increased sensitivity for the detection of LNI for all risk thresholds in both models, countered by a decreased specificity, compared with DRE T-stage. CONCLUSION: T-stage as assessed by mpMRI is an appropriate alternative for T-stage assessed by DRE to determine nomogram-based risk of LNI in patients with prostate cancer, and was associated with improved model performance of both the MSKCC 2018 and Briganti 2012 nomograms.

Effect of Intra-Operative Hypothermia on Post-Operative Morbidity in Patients with Colorectal Cancer.

Background: Current guidelines recommend maintaining intra-operative normothermia to avoid surgical site infections (SSI) after colorectal cancer surgery. The aim of this study was to assess whether compliance with normothermia as part of temperature management measures is an effective strategy to reduce post-operative SSI and complications. Patients and Methods: This was a cohort study of patients undergoing surgery for primary colorectal cancer in 2011-2017 in a large teaching hospital in which temperature management using the Bair Hugger™ system (3M™ Center, St. Paul, MN) was standard care. Data from the prospective Dutch Surgical Audit (DCRA) database were complemented by highly granular intra-operative central body temperature data. A multivariable logistic regression model was used. Results: A total of 1,015 patients undergoing surgery for primary colorectal cancer were included. Temperature outcomes for the entire study cohort were as follows: mean temperature was 36.3°C (standard deviation [SD] ±0.5°C), median temperature nadir was 35.8°C (interquartile range [IQR] 35.6°C-36.1°C), median percentage of time at nadir was 2.0% (IQR 0.8%-10.7%), and median percentage of time less than 36.0°C was 1.0% (IQR 0.0%-33.3%). Thirty-day SSI rate was 10% (n = 101). Logistic regression models adjusting for gender, diabetes mellitus, body mass index (BMI), rectal cancer, duration of surgery, open surgery, emergency surgery, and period of surgery showed no association between any of the four temperature outcomes and SSI. Multivariable analysis also failed to show an association between intra-operative hypothermia and 30-day complications, mortality, or re-admission. Conclusions: In a hospital in which temperature management is standard care, intra-operative hypothermia and SSI rates in patients undergoing colorectal cancer surgery were low. Compliance with normothermia appears to be an effective strategy to reduce SSI.

'Care for Outcomes': systematic development of a set of outcome indicators to improve patient-relevant outcomes for patients with lung cancer.

OBJECTIVES: Measuring quality of care is important, however many of the quality indicators used do not focus on outcome of treatment and aspects which are valuable for patients and physicians. The project 'Care for Outcomes' aims to establish a relevant set of outcome indicators for lung cancer. SETTING: Network of seven large, non-university teaching hospitals in the Netherlands (Santeon). METHODS: By reviewing the literature, a list of potential outcome indicators for patients with lung cancer was composed and subsequently prioritised by expert's opinion. Three external parties, with expertise on lung cancer, clinical management and public health, evaluated and reduced the list of indicators to a working set. Finally, the resulting selection of outcome indicators was tested for feasibility and discrimination in patient data, by collecting retrospective data and performing regression and survival analyses. PARTICIPANTS: Development of the indicator set in six Santeon hospitals. Retrospective cohort study in 5922 patients diagnosed with lung cancer (all types and stages). RESULTS: Selected outcome indicators were divided into three levels of outcome (tiers). The first tier about survival and the process of recovery include mortality, survival, positive resection margins, rethoracotomy after resection and quality of life at baseline and after 3, 6 and 12 months. Tier 2 concerning the sustainability of the recovery include complications after resection and toxicity after chemotherapy and/or radiation. Tier 3 about sustainability of health revealed no measurable outcomes. The retrospective data collection showed differences between hospitals and variation in case mix. CONCLUSION: A relevant set of outcome indicators for lung cancer was systematically developed. This set has the potential to compare quality of care between hospitals and inform patients with lung cancer about outcomes. The project is ongoing in the current Santeon Value-Based Health Care programme through quality and improvement cycles.

Severe postpartum hemorrhage increases risk of posttraumatic stress disorder: a prospective cohort study.

PURPOSE: To evaluate whether severe postpartum hemorrhage (PPH) is a risk factor for posttraumatic stress disorder (PTSD). Severe PPH can be experienced as a traumatic event. PTSD leads to negative mental health effects. Knowing risk factors for PTSD during childbirth offers opportunities for early interventions, which may prevent the development of PTSD. MATERIALS AND METHODS: In this prospective study, we compared two groups of participants; women with ≥2000 mL of blood loss (severe PPH, patients) and women with ≤500 mL of blood loss (controls). Participants were screened for PTSD using the PCL-5 four to six weeks after delivery. Positive screening was followed by the CAPS-5 to diagnose PTSD. RESULTS: We included 187 PPH patients and 121 controls. Median PCL-5 scores were higher for PPH patients (5.0) than controls (4.0, p = 0.005). Thirteen PPH patients (7.0%) and two controls (1.7%) scored ≥32 on the PCL-5, indicative of probable PTSD (OR 4.45, 95% CI 0.99-20.06, p = 0.035). Significant more PPH patients than controls met criteria for a clinical diagnosis of PTSD on the CAPS-5 (n = 10, 5.6% vs n = 0, 0.0%; p = 0.007). CONCLUSIONS: There is a significant and clinically relevant increased risk for developing PTSD after severe PPH. Gynecologists and midwives are advised to screen for PTSD at postpartum follow-up visits to prevent long-term negative mental health effects. CLINICAL TRIAL REGISTRATION: NL50273.100.14.

Multiparametric Magnetic Resonance Imaging Should Be Preferred Over Digital Rectal Examination for Prostate Cancer Local Staging and Disease Risk Classification.

OBJECTIVE: To assess the impact of multiparametric magnetic resonance imaging (mp-MRI) local tumor staging on prostate cancer risk stratification and choice of treatment. MATERIALS AND METHODS: Prostate cancer patients, newly diagnosed from 2017 to 2018 at 7 Dutch teaching hospitals were included. Risk group classification was done twice, using either digital rectal examination (DRE) or mp-MRI information. Risk group migration and rates of treatment intensification associated with mp-MRI upstaging were established. Diagnostic accuracy measures for the detection of nonorgan-confined disease (stage ≥T3a), for both DRE and mp-MRI, were assessed in patients undergoing robot-assisted radical prostatectomy. RESULTS: A total of 1683 patients were included. Upstaging due to mp-MRI staging occurred in 493 of 1683 (29%) patients and downstaging in 43 of 1683 (3%) patients. Upstaging was associated with significant higher odds for treatment intensification (odds ratio [OR]: 3.5 95% confidence interval [CI] 1.9-6.5). Stage ≥T3a on mp-MRI was the most common reason for risk group upstaging (77%). Sensitivity for the detection of stage ≥T3a was higher for mp-MRI compared to DRE (51% vs 12%, P <.001), whereas specificity was lower (82% vs 97%, P <.001). Mp-MRI resulted in a significantly higher cumulative rate of true positive and true negative stage ≥T3a predictions compared with DRE (67% vs 58%, P <.001). CONCLUSION: Use of mp-MRI tumor stage for prostate cancer risk classification leads to upstaging in 1 of 3 patients. Mp-MRI enables superior detection of nonorgan-confined disease compared with DRE, and should be the preferred tool for determining clinical tumor stage.

Implementation of a preoperative multidisciplinary team approach for frail colorectal cancer patients: Influence on patient selection, prehabilitation and outcome.

OBJECTIVE: To determine the influence of a preoperative multidisciplinary evaluation for frail older patients with colorectal cancer (CRC) on preoperative decision making and postoperative outcomes. BACKGROUND: Surgery is the main treatment for CRC. Older patients are at increased risk for adverse outcomes. For complex surgical cases, a multidisciplinary team (MDT) approach has been suggested to improve postoperative outcome. Evidence is lacking. METHODS: Historical cohort study from 2015 to 2018 in surgical patients ≥70 years with CRC. Frailty screening was used to appraise the somatic, functional and psychosocial health status. An MDT weighed the risk of surgery versus the expected gain in survival to guide preoperative decision making and initiate a prehabilitation program. Primary endpoint was the occurrence of a Clavien-Dindo (CD) Grade III-V complication. Secondary endpoints included the occurrence of any complication (CD II-V), length of hospital stay, discharge destination, readmission rate and overall survival. RESULTS: 466 patients were included and 146 (31.3%) patients were referred for MDT evaluation. MDT patients were more often too frail for surgery compared to non-MDT patients (10.3% vs 2.2%, P = .01). Frailty was associated with overall mortality (aOR 2.6 95% CI 1.1-6.1). Prehabilitation was more often performed in MDT patients (74.8% vs 23.4% in non-MDT patients). Despite an increased risk, MDT patients did not suffer more postoperative complications (CD III-V) than non-MDT patients (14.9% vs 12.4%; P = .48). Overall survival was worse in MDT patients (35 (32-37) vs 48 (47-50) months in non-MDT patients; P < .01). CONCLUSIONS: Implementation of preoperative MDT evaluation for frail patients with CRC improves risk stratification and prehabilitation, resulting in comparable postoperative outcomes compared to non-frail patients. However, frail patients are at increased risk for worse overall survival.

Selecting interventions to improve patient-relevant outcomes in health care for aortic valve disease - the Intervention Selection Toolbox.

BACKGROUND: Measuring and improving outcomes is a central element of value-based health care. However, selecting improvement interventions based on outcome measures is complex and tools to support the selection process are lacking. The goal was to present strategies for the systematic identification and selection of improvement interventions applied to the case of aortic valve disease and to combine various methods of process and outcome assessment into one integrated approach for quality improvement. METHODS: For this case study a concept-driven mixed-method approach was applied for the identification of improvement intervention clusters including: (1) benchmarking outcomes, (2) data exploration, (3) care delivery process analysis, and (4) monitoring of ongoing improvements. The main outcome measures were long-term survival and 30-day mortality. For the selection of an improvement intervention, the causal relations between the potential improvement interventions and outcome measures were quantified followed by a team selection based on consensus from a multidisciplinary team of professionals. RESULTS: The study resulted in a toolbox: the Intervention Selection Toolbox (IST). The toolbox comprises two phases: (a) identifying potential for improvement, and (b) selecting an effective intervention from the four clusters expected to lead to the desired improvement in outcomes. The improvements identified for the case of aortic valve disease with impact on long-term survival in the context of the studied hospital in 2015 include: anticoagulation policy, increased attention to nutritional status of patients and determining frailty of patients before the treatment decision. CONCLUSIONS: Identifying potential for improvement and carefully selecting improvement interventions based on (clinical) outcome data demands a multifaceted approach. Our toolbox integrates both care delivery process analyses and outcome analyses. The toolbox is recommended for use in hospital care for the selection of high-impact improvement interventions.

External validation of the Martini nomogram for prediction of side-specific extraprostatic extension of prostate cancer in patients undergoing robot-assisted radical prostatectomy.

INTRODUCTION: To establish oncological safe nerve-sparing robot-assisted radical prostatectomy, accurate assessment of extraprostatic extension (EPE) is critical. A recently developed nomogram including magnetic resonance imaging parameters accurately predicted side-specific EPE in the development cohort. The aim of this study is to assess this model's performance in an external patient population. PATIENTS AND METHODS: Model fit was assessed in a cohort of 550 patients who underwent robot-assisted radical prostatectomy in 2014 to 2017 for prostate cancer. Model calibration was evaluated using calibration slopes. Discriminative ability was quantified using the area under the receiver operating characteristic curve. Model updating was done by adjusting the linear predictor to minimize differences in expected and observed risk for EPE. RESULTS: A total of 792 prostate lobes were included for model validation. Discriminative ability expressed in terms of receiver operating characteristic curve was 0.78, 95%CI 0.75-0.82. Graphical evaluation of the calibration showed poor fit with a high disagreement between predicted probabilities and observed probabilities of EPE in the population. Model updating resulted in excellent agreement between mean predicted and observed probabilities. However, calibration plots showed substantial miscalibration; including both under- and overestimation. CONCLUSION: External validation of the novel nomogram for the prediction of side specific EPE developed by Martini and co-workers showed good discriminative ability but poor calibration. After updating, substantial miscalibration was still present. Use of this nomogram for individualized risk predictions is therefore not recommended.

Lower versus Traditional Treatment Threshold for Neonatal Hypoglycemia.

BACKGROUND: Worldwide, many newborns who are preterm, small or large for gestational age, or born to mothers with diabetes are screened for hypoglycemia, with a goal of preventing brain injury. However, there is no consensus on a treatment threshold that is safe but also avoids overtreatment. METHODS: In a multicenter, randomized, noninferiority trial involving 689 otherwise healthy newborns born at 35 weeks of gestation or later and identified as being at risk for hypoglycemia, we compared two threshold values for treatment of asymptomatic moderate hypoglycemia. We sought to determine whether a management strategy that used a lower threshold (treatment administered at a glucose concentration of <36 mg per deciliter [2.0 mmol per liter]) would be noninferior to a traditional threshold (treatment at a glucose concentration of <47 mg per deciliter [2.6 mmol per liter]) with respect to psychomotor development at 18 months, assessed with the Bayley Scales of Infant and Toddler Development, third edition, Dutch version (Bayley-III-NL; scores range from 50 to 150 [mean {±SD}, 100±15]), with higher scores indicating more advanced development and 7.5 points (one half the SD) representing a clinically important difference). The lower threshold would be considered noninferior if scores were less than 7.5 points lower than scores in the traditional-threshold group. RESULTS: Bayley-III-NL scores were assessed in 287 of the 348 children (82.5%) in the lower-threshold group and in 295 of the 341 children (86.5%) in the traditional-threshold group. Cognitive and motor outcome scores were similar in the two groups (mean scores [±SE], 102.9±0.7 [cognitive] and 104.6±0.7 [motor] in the lower-threshold group and 102.2±0.7 [cognitive] and 104.9±0.7 [motor] in the traditional-threshold group). The prespecified inferiority limit was not crossed. The mean glucose concentration was 57±0.4 mg per deciliter (3.2±0.02 mmol per liter) in the lower-threshold group and 61±0.5 mg per deciliter (3.4±0.03 mmol per liter) in the traditional-threshold group. Fewer and less severe hypoglycemic episodes occurred in the traditional-threshold group, but that group had more invasive diagnostic and treatment interventions. Serious adverse events in the lower-threshold group included convulsions (during normoglycemia) in one newborn and one death. CONCLUSIONS: In otherwise healthy newborns with asymptomatic moderate hypoglycemia, a lower glucose treatment threshold (36 mg per deciliter) was noninferior to a traditional threshold (47 mg per deciliter) with regard to psychomotor development at 18 months. (Funded by the Netherlands Organization for Health Research and Development; HypoEXIT Current Controlled Trials number, ISRCTN79705768.).