Data quality and auditing within the Netherlands Heart Registration: using the PCI registry as an example.

AIM: The aim of this article is to present the method and results of the data quality control system and audit within the Netherlands Heart Registration (NHR) using data of patients treated with percutaneous coronary intervention (PCI) in the Netherlands as an example. METHODS: The NHR is a Dutch nationwide registry of all cardiac interventions, comprising data from all 71 hospitals, of which 30 are cardiac intervention or heart centres. Each year, within the NHR, data validation and verification is performed by standard quality controls and monitoring visits (audits). For the audit in 2019, a sample of 50-100 medical records of patients treated with PCI in 2016 and 2017 were reviewed in each hospital by an independent auditor. The data received by the NHR were compared with the information in the hospitals' medical records. In total 12 patient characteristics, 5 intervention variables and 3 outcome variables were screened. The value of a variable was considered discrepant if more than 10% of the medical records reviewed regarding this variable were not consistent with the reported data received by the NHR. RESULTS: For all variables together, the consistency was high, 97.6%. All variables, except multivessel disease (9.3% discrepancy in the 2622 medical records reviewed), had an accuracy above 95%. CONCLUSION: The results of the audit of the PCI medical records show that the overall quality of the data is high. For variables such as multivessel disease it is important to improve knowledge of the definitions and to train all those involved in the registration process.

The association of body mass index with safety and effectiveness of first-line carboplatin-based chemotherapy in patients with metastatic non-small cell lung cancer.

INTRODUCTION: Carboplatin is an anticancer drug used for treatment of various types of cancer including non-small cell lung cancer (NSCLC). Dosing is based on estimated glomerular filtration rate (GFR) using the Cockcroft-Gault formula. In overweight patients, the GFR is more likely overestimated, resulting in a potentially overdose of carboplatin affecting treatment response. This study investigated the association of body mass index (BMI) on overall survival (OS) and progression-free survival (PFS) in stage-IV NSCLC patients treated with first-line carboplatin-based chemotherapy. Secondary safety endpoints were thrombocytopenia and toxicity-related hospitalizations. MATERIALS AND METHODS: This was a retrospective multicenter cohort study. Patients were categorized according to BMI<25.0 kg/m2 (normal weight and reference), 25.0-29.9 kg/m2 (overweight) or ≥30.0 kg/m2 (obese). For survival analyses adjusted hazard ratios [aHR] were calculated using multivariate Cox regression analysis. Secondary outcomes were analyzed using multivariate logistic regression providing adjusted odd ratios [aOR]. RESULTS: Overweight patients (n=174) had a significantly better OS (aHR=0.72, 95%-CI:0.59-0.89) and PFS (aHR=0.74, 95%-CI:0.61-0.90) compared to normal weight patients (n=268). OS nor PFS were different in obese (n=51) compared to normal weight patients. However, obesity was associated with significantly higher incidences of thrombocytopenia grade ≥3 (aOR=3.47, 95%-CI:1.75-6.90). CONCLUSION: This study shows a significantly longer survival for overweight compared to normal weight patients. Obese patients have an increased risk for grade ≥3 thrombocytopenia without a difference in survival following carboplatin-based chemotherapy. The implications for clinical practice are to use the Cockcroft-Gault formula with caution in patients with BMI≥30.0 kg/m2, and to verify calculated dosing of carboplatin for appropriateness.

Association between public media and trends in new acute coronary syndrome presentations during the first COVID­19 wave in the Netherlands.

BACKGROUND: We aimed to evaluate the association between public media and trends in new presentations of acute coronary syndrome (ACS) during the first wave of the coronavirus disease 2019 (COVID­19) in the Netherlands. METHODS: New ACS presentations per week in 73 hospitals during the first half of 2019 and 2020 were retrieved from the national organisation Dutch Hospital Data and incidence rates were calculated. Stratified analyses were performed by region, type of ACS and patient characteristics. RESULTS: After the first confirmed COVID­19 case and during lockdown, numbers declined by up to 41% (95% confidence interval (CI): 36-47%) compared to 2019. This reduction was more pronounced for non-ST-segment elevation myocardial infarction (NSTEMI) (48%; 95% CI: 39-55%) and unstable angina (UA; 50%; 95% CI: 40-59%) than for STEMI (34%; 95% CI: 23-43%). There was no association between ACS and COVID­19 incidence rate per region. After the steep decline, a public campaign encouraged patients not to postpone hospital visits. Numbers then increased, without a rebound effect. Trends were similar irrespective of sex, age or socio-economic status. During the outbreak, compared to coronary artery bypass graft procedures, relatively more (acute) percutaneous coronary interventions for NSTEMI and UA were performed. CONCLUSION: New ACS presentations decreased by up to 41%. Lockdown measures and public campaigns, rather than COVID­19 incidence, were associated with significant changes in new ACS presentations. Even though causality cannot be established, this emphasises the role of the public media and healthcare organisations in informing patients to prevent underdiagnoses of ACS and associated health damage.

Daylight saving time does not seem to be associated with number of percutaneous coronary interventions for acute myocardial infarction in the Netherlands.

BACKGROUND: In multiple studies, the potential relationship between daylight saving time (DST) and the occurrence of acute myocardial infarction (MI) has been investigated, with mixed results. Using the Dutch Percutaneous Coronary Intervention (PCI) registry facilitated by the Netherlands Heart Registration, we investigated whether the transitions to and from DST interact with the incidence rate of PCI for acute MI. METHODS: We assessed changes in hospital admissions for patients with ST-elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) undergoing PCI between 1 January 2015 and 31 December 2018. We compared the incidence rate of PCI procedures during the first 3 or 7 days after the transition with that during a control period (2 weeks before transition plus second week after transition). Incidence rate ratio (IRR) was calculated using Poisson regression. Potential gender differences were also investigated. RESULTS: A total of 80,970 PCI procedures for STEMI or NSTEMI were performed. No difference in incidence rate a week after the transition to DST in spring was observed for STEMI (IRR 0.95, 95% confidence interval (CI) 0.87-1.03) or NSTEMI (IRR 1.04, 95% CI 0.96-1.12). After the transition from DST in autumn, the IRR was also comparable with the control period (STEMI: 1.03, 95% CI 0.95-1.12, and NSTEMI: 0.98, 95% CI 0.91-1.06). Observing the first 3 days after each transition yielded similar results. Gender-specific results were comparable. CONCLUSION: Based on data from a large, nationwide registry, there was no correlation between the transition to or from DST and a change in the incidence rate of PCI for acute MI.

Incidence and outcomes of chronic total occlusion percutaneous coronary intervention in the Netherlands: data from a nationwide registry.

BACKGROUND: Patients with chronic total coronary occlusions (CTO) are at increased risk for poor clinical outcomes. We aimed to determine the incidence of CTO percutaneous coronary intervention (PCI) and to identify CTO patients at risk for cardiac events in the nationwide Netherlands Heart Registration (NHR). METHODS: We included all PCI procedures with ≥1 CTO registered in the NHR from January 2015 to December 2018, excluding acute interventions. We used multivariable logistic regression of baseline characteristics to calculate the risk for events as odds ratios (OR) with 95% confidence intervals (CI). RESULTS: Of the PCIs performed during the study period, 6.3% (8,343/133,042) were for CTOs, with the percentage increasing significantly over time from 5.9% in 2015 to 6.6% in 2018 (p < 0.001). Coronary artery bypass grafting <24 h was carried out in 0.3%, and the only significant predictor was diabetes mellitus (OR 2.97, 95% CI 1.04-8.49, p = 0.042). Myocardial infarction (MI) <30 days occurred in 0.5%, and renal insufficiency (i.e. estimated glomerular filtration rate <30 ml/min per 1.73 m2) was identified as an independent predictor (OR 4.70, 95% CI 1.07-20.61, p = 0.040). Among patients undergoing CTO-PCI, 1­year mortality was 3.7%, and independent predictors included renal insufficiency (OR 5.59, 95% CI 3.25-9.59, p < 0.001), left ventricular ejection fraction <30% (OR 3.43, 95% CI 2.00-5.90, p < 0.001), previous MI (OR 1.62, 95% CI 1.14-2.31, p = 0.007) and age (OR 1.06 per year increment, 95% CI 1.04-1.07, p < 0.001). Target-vessel revascularisation <1 year occurred in 11.3%. CONCLUSION: CTO-PCI is still infrequently performed in the Netherlands. The most important predictor of mortality after CTO-PCI was renal insufficiency. Identification of patients at risk may help improve the prognosis of CTO patients in the future.

Better survival after transcatheter aortic valve replacement by process improvements.

OBJECTIVE: The aim of this study is to assess the effects on procedural, 30-day, and 1­year all-cause mortality by a newly introduced quality improvement strategy in patients after transcatheter aortic valve replacement (TAVR). METHODS: In October 2015, a coherent set of quality improving interventions with respect to patient geriatric screening, general diagnostic examination and safety of the procedure was implemented at a single centre in the Netherlands. Patients undergoing TAVR in 2013-2018 were included for retrospective analysis. Mortality was assessed in the pre-quality improvement strategy cohort (January 2013 to October 2015; cohort A) and in the post-quality improvement strategy cohort (November 2015 to December 2018; cohort B). Logistic regression analysis was used to estimate the influence of patient and procedural characteristics on the results of the quality improvement strategy in terms of procedural, 30-day, and 1­year all-cause mortality. RESULTS: In total, 806 patients were analysed with 274 patients in cohort A and 532 patients in cohort B. After introduction of the quality improvement strategy, procedural (4.4% to 1.3%, p < 0.01), 30-day (8.4% to 2.7%, p < 0.01) and 1­year (16.4% to 8.5%, p < 0.01) all-cause mortality significantly decreased. Multivariate regression analysis showed that the quality improvement strategy also significantly reduced 30-day (odds ratio [OR] 0.19, 95% confidence interval [CI] 0.09-0.42) and 1­year (OR 0.38, 95% CI 0.24-0.61) all-cause mortality if corrected for patient characteristics. CONCLUSION: Structural meetings on evaluation of outcomes highlight potential areas for improvement and subsequent outcome-based quality improvement initiatives can result in lower procedural, 30-day, and 1­year all-cause mortality.

Ovarian cancer risk after salpingectomy for ectopic pregnancy or hydrosalpinx: results of the OCASE nationwide population-based database study.

STUDY QUESTION: What is the effect of salpingectomy for ectopic pregnancy or hydrosalpinx at a young age on ovarian cancer risk compared to no salpingectomy for any reason? SUMMARY ANSWER: We found no significant reduction in ovarian cancer risk after salpingectomy for ectopic pregnancy or hydrosalpinx. WHAT IS KNOWN ALREADY: Salpingectomy may reduce ovarian cancer incidence, although the lag-time between intervention and therapeutic effect remains to be elucidated. STUDY DESIGN, SIZE, DURATION: This nationwide population-based database study uses the Dutch pathology database to identify all women who underwent salpingectomy for ectopic pregnancy or hydrosalpinx between January 1990 and December 2012 and compared ovarian cancer incidence to a control group of women who had a benign dermal nevus removed, matched for age at the time and year of procedure. PARTICIPANTS/MATERIALS, SETTING, METHODS: After selection and manual control of intervention and control group, ovarian cancer incidence was recorded. Hazard ratios (HRs) with 95% CI for the development of ovarian cancer were calculated with Cox regression analyses, both unadjusted and adjusted for age. Subgroup analyses were performed to investigate lag-time between intervention and protective effect. MAIN RESULTS AND THE ROLE OF CHANCE: In all, 18 961 women were included in the intervention group; 17 106 women had a unilateral salpingectomy and 1855 had a bilateral salpingectomy. The control group consisted of 23 686 women. With 14 ovarian cancer cases in the intervention group, the incidence rate (IR) of ovarian cancer was 5.4 (95% CI 3.1-8.9) per 100 000 person-years. In the control group, there were 24 ovarian cancer cases, resulting in an IR of 7.1 (95% CI 4.7-10.5) per 100 000 person-years (P = 0.34). The age-adjusted HR for ovarian cancer was 0.76 (95% CI 0.39-1.47) after salpingectomy. Unilateral salpingectomy resulted in an age-adjusted HR of 0.81 (95% CI 0.41-1.59) and bilateral salpingectomy resulted in an age-adjusted HR of 0.43 (95% CI 0.06-3.16) based on one case. None of our subgroup analysis for lag-time resulted in a significant difference in ovarian cancer incidence between intervention and control group. The difference in ovarian cancer incidence appeared largest in women with at least 8 years of follow-up (P = 0.08). LIMITATIONS, REASONS FOR CAUTION: Due to the young population, ovarian cancer incidence is low, even at the end of follow-up. Furthermore, due to the anonymous nature of the pathology registry, we were unable to adjust for confounding factors. WIDER IMPLICATIONS OF THE FINDINGS: Although results did not reach statistical significance, they add to the available data on ovarian cancer incidence after salpingectomy. Our subgroup analysis suggests there may be no benefit in the first years following salpingectomy. STUDY FUNDING/COMPETING INTEREST(S): None. TRIAL REGISTRATION NUMBER: N/A.

Image qualities and mood variability: Evaluating the utility of an imagery survey for bipolar disorder.

OBJECTIVE: Imagery appears to play an important role in mood variability, a core symptom of patients suffering from bipolar disorder. The present study aimed to explore the validity and reliability of an online self-report measure of imagery, the Dutch Imagery Survey (DImS). The DImS is an adaptation of the Imagery interview used in research on imagery in mental disorders. The present study additionally explored the ability of the DImS to detect relationships between self-reported imagery and subsequent mood and subsequent behaviour. METHOD: 135 students completed the DImS and additional mental imagery and mood questionnaires. For re-test reliability, 42 students completed the survey again within two days. RESULTS: Internal consistencies and test-retest scores of the five scales of the DImS were reasonable. Imagery Quality correlated with Emotions, and to a lesser degree with Behaviour. Positive Appraisals correlated with Positive Emotions, Negative Appraisals with Negative Emotions, and Positive appraisals with Behaviour. Frequency of Imagery, Imagery Quality and Positive Appraisals correlated with elevated mood. Imagery Quality and Negative Appraisals correlated with low mood. The DImS took approximately 15 min to complete. LIMITATIONS: Re-test reliability was limited due to participants changing their dominant image. Results need to be replicated in a clinical sample. CONCLUSIONS: Psychometric findings with the DImS appeared reasonable and consistent and showed that, in line with other recent studies, imagery is related to current mood and to both self-perceived emotion and subsequent behaviour. These findings suggested that the DImS is suitable to study the role of imagery in bipolar mood variability.

Do women benefit more than men from off-pump coronary artery bypass grafting?

OBJECTIVES: Outcomes after coronary artery bypass grafting (CABG) are worse in women than in men. This study aims to investigate whether off-pump coronary artery bypass (OPCAB) surgery improves the outcomes in women by comparing different outcome measures in both genders. METHODS: Patients who underwent isolated CABG, either on-pump (ONCAB) or OPCAB, between January 1998 and June 2017 were included. Primary endpoints were 30-day and 120-day mortality. Logistic regression models were constructed to evaluate the effect of the CABG technique on important outcomes such as mortality and the need for blood transfusion. RESULTS: The data of 17,052 patients were analysed, 3,684 of whom were women (414 OPCAB) and 13,368 men (1,483 OPCAB). The mean number of grafts was lower in the OPCAB group of both genders (p < 0.001). Postoperatively, both men and women undergoing OPCAB surgery received fewer red blood cell transfusions (p < 0.001) and had higher postoperative haemoglobin levels (p < 0.001) than those undergoing ONCAB. Early mortality occurred less frequently after OPCAB surgery in both genders, although the difference was not significant. However, 120-day mortality was significantly lower after OPCAB surgery in women, even after correction for preoperative risk factors [odds ratio (OR) = 0.356, 95% confidence interval (CI) 0.144-0.882, p = 0.026]. The difference in 120-day mortality was not significant in men (OR = 0.787, 95% CI 0.498-1.246, p = 0.307). CONCLUSIONS: Women undergoing CABG benefit more from OPCAB surgery than from ONCAB surgery in terms of 120-day mortality. This difference was not found in men in our patient population.

Opportunistic salpingectomy in women undergoing hysterectomy: Results from the HYSTUB randomised controlled trial.

OBJECTIVE: To evaluate whether opportunistic salpingectomy in premenopausal women undergoing hysterectomy for benign indications is both hormonally and surgically safe, compared with hysterectomy without salpingectomy. STUDY DESIGN: In this multicentre randomised controlled trial, women were randomised to undergo either hysterectomy with opportunistic bilateral salpingectomy (intervention group) or standard hysterectomy with preservation of the Fallopian tubes (control group). MAIN OUTCOME MEASURES: The primary outcome was the difference in serum anti-Müllerian hormone concentration (ΔAMH), measured pre-surgery and 6 months post-surgery. Secondary outcomes were surgical outcomes and duration of hospital stay. The sample size was powered at 50 participants per group (n=100) to compare ΔAMH after hysterectomy with salpingectomy to ΔAMH after standard hysterectomy. RESULTS: Between March 2013 and December 2016, 104 women, aged 30-55 years, were randomly allocated to hysterectomy with opportunistic bilateral salpingectomy (n=52) or standard hysterectomy (n=52). The baseline characteristics did not differ between the two groups. The median ΔAMH was -0.14pmol/L (IQR -1.47-0.95) in the intervention group and 0.00pmol/L (IQR -1.05-0.80) in the control group (p=0.49). The addition of salpingectomy did not impair surgical results and it did not affect duration of hospital stay. CONCLUSION: Addition of opportunistic bilateral salpingectomy during hysterectomy did not result in a larger effect on ovarian reserve when compared with hysterectomy alone, neither did it affect surgical outcomes. Therefore, opportunistic salpingectomy seems to be a safe procedure in premenopausal women undergoing hysterectomy for benign gynaecological conditions.

Improved and more effective algorithms to screen for nutrient deficiencies after bariatric surgery.

BACKGROUND/OBJECTIVES: Most bariatric guidelines recommend frequent lab monitoring of patients to detect nutrient and vitamin deficiencies as early as possible. The aim of this study was to optimize the cost effectiveness of the nutrient panel, by developing an algorithm, which detects nutrient deficiencies at lower costs. SUBJECTS/METHODS: In this retrospective study, 2055 patients who had undergone Laparoscopic Roux-Y Gastric Bypass (LRYGB) and Laparoscopic Sleeve Gastrectomy (LSG) surgery at Catharina Hospital Eindhoven between January 2009 and December 2013 were included. Perioperative biochemical measurements (7 days before and 127 days after surgery) and measurements >549 days before surgery were excluded. For analysis, the most recent preoperative and postoperative measurements were selected for each biochemical parameter separately. First, the amount of moderate and severe deficiencies were calculated. Second, we investigated whether each variable (vitamins A, B1, B6, B12, D, folate, ferritin, zinc and magnesium) could predict the presence of deficiency. RESULTS: In total, 561 (LRYGB) and 831 (LSG) patients had at least preoperative and postoperative values of vitamin A, B1, B6, B12, D, folate, ferritin, zinc or magnesium. The algorithm reduces vitamin D, B12, B6, B1 and ferritin examinations by 15, 11, 28, 28 and 38%, respectively, without missing clinically relevant deficiencies. The corresponding potential cost savings was 14%. CONCLUSIONS: This study identified substantial cost savings in laboratory test for both LRYGB and LSG procedures. The potential cost reduction of 14% might even be increased to 42% when less frequent moderate deficiencies are not screened anymore, whereas >99.0 of moderate deficiencies will be detected.

Crew Resource Management in the Intensive Care Unit: a prospective 3-year cohort study.

BACKGROUND: Human factors account for the majority of adverse events in both aviation and medicine. Human factors awareness training entitled "Crew Resource Management (CRM)" is associated with improved aviation safety. We determined whether implementation of CRM impacts outcome in critically ill patients. METHODS: We performed a prospective 3-year cohort study in a 32-bed ICU, admitting 2500-3000 patients yearly. At the end of the baseline year, all personnel received CRM training, followed by 1 year of implementation. The third year was defined as the clinical effect year. All 7271 patients admitted to the ICU in the study period were included. The primary outcome measure was ICU complication rate. Secondary outcome measures were ICU and hospital length of stay, and standardized mortality ratio. RESULTS: Occurrence of serious complications was 67.1/1000 patients and 66.4/1000 patients during the baseline and implementation year respectively, decreasing to 50.9/1000 patients in the post-implementation year (P = 0.03). Adjusted odds ratios for occurrence of complications were 0.92 (95% CI 0.71-1.19, P = 0.52) and 0.66 (95% CI 0.51-0.87, P = 0.003) in the implementation and post-implementation year. The incidence of cardiac arrests was 9.2/1000 patients and 8.3/1000 patients during the baseline and implementation year, decreasing to 3.5/1000 patients (P = 0.04) in the post-implementation year, while cardiopulmonary resuscitation success rate increased from 19% to 55% and 67% (P = 0.02). Standardized mortality ratio decreased from 0.72 (95% CI 0.63-0.81) in the baseline year to 0.60 (95% CI 0.53-0.67) in the post-implementation year (P = 0.04). CONCLUSION: Our data indicate an association between CRM implementation and reduction in serious complications and lower mortality in critically ill patients.

Femoral Mechanical-Anatomical Angle Measurements in Total Knee Arthroplasty: Analog versus Digital.

Preoperative planning in total knee arthroplasty with intramedullary guiding systems requires the measurement of the femoral mechanical-anatomical angle (FMAA) for optimal alignment correction. The main goal of this study was to assess the agreement between two digital FMAA measurements and the analog FMAA measurement. Overall 41 anteroposterior weight-bearing hip-to-ankle radiographs of patients undergoing total knee arthroplasty were used for the measurements of the FMAA. The analog method (gold standard, GS) was compared with two new digital methods (DIG1 and DIG2) using intraclass correlation (ICC) and Bland-Altman plots, measured by three blinded raters. The ICC for measurements of the FMAA comparing the GS and DIG1 was 0.48 (95% confidence interval [CI] 0.20-0.68), and 0.53 (95% CI 0.26-0.73) for comparing GS and DIG2. The ICC between raters for DIG1 was 0.79 (95% CI 0.68-0.88) and 0.88 (95% CI 0.80-0.93) for DIG2. Bland-Altman plots showed a mean difference between the GS and DIG1 of -0.44 degrees, with 95% limits of agreement from 1.21 to -2.09 degrees. The mean difference between the GS and DIG2 was -0.68 degrees with 95% limits of agreement from 0.99 to -2.35 degrees. It was concluded that the digital FMAA measurement is less reliable than analog measurement in total knee arthroplasty.

Editor's choice--The effect of supervision on walking distance in patients with intermittent claudication: a meta-analysis.

BACKGROUND: A number of reviews have reported the influence of exercise therapy (ET) for the treatment of intermittent claudication (IC). However, a complete overview of different types of ET is lacking. The aim of this meta-analysis was to study the effect of supervision on walking capacity in patients with IC. It was hypothesized that there was a positive treatment effect in relation to the intensity of supervision and improvement in walking capacity (i.e., a "dose-response" hypothesis). METHODS: A systematic search in the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE databases was performed. Only randomized controlled trials (RCTs) evaluating the efficacy of an ET in IC were included. Type of supervision, treadmill protocol, length of ET, total training volume, and change in walking distance were extracted. RCTs were categorised according to type of support: no exercise, walking advice, home-based exercise (HB-ET), and supervised exercise therapy (SET). A standardised mean difference between pre- and post-training maximal walking distance (MWD) and pain-free walking distance (PFWD) was calculated for all subgroups at 6 weeks, and 3 and 6 months of follow up. RESULTS: Thirty studies involving 1406 patients with IC were included. The overall quality was moderate-to-good, although number of included patients varied widely (20-304). The intensity of supervision was directly related to MWD and PFWD. SET was superior to other conservative treatment regimens with respect to improvement in walking distances at all follow-ups. However, the difference between HB-ET and SET at 6 months of follow up was not significant. CONCLUSION: Supervised exercise therapy for intermittent claudication is superior to all other forms of exercise therapy. Intensity of supervision is related to improved walking distance.

Randomized clinical trial of trigger point infiltration with lidocaine to diagnose anterior cutaneous nerve entrapment syndrome.

BACKGROUND: Anterior cutaneous nerve entrapment syndrome (ACNES) is hardly considered in the differential diagnosis of chronic abdominal pain. Some even doubt the existence of such a syndrome and attribute reported successful treatment results to a placebo effect. The objective was to clarify the role of local anaesthetic injection in diagnosing ACNES. The hypothesis was that pain attenuation following lidocaine injection would be greater than that after saline injection. METHODS: Patients aged over 18 years with suspected ACNES were randomized to receive an injection of 10 ml 1 per cent lidocaine or saline into the point of maximal abdominal wall pain just beneath the anterior fascia of the rectus abdominis muscle. Pain was recorded using a visual analogue scale (VAS; 1-100 mm) and a verbal rating scale (VRS; 0, no pain; 4, severe pain) during physical examination just before and 15-20 min after injection. A reduction of at least 50 per cent on the VAS and/or 2 points on the VRS was considered a successful response. RESULTS: Between August 2008 and December 2010, 48 patients were randomized equally (7 men and 41 women, median age 47 years). Four patients in the saline group reported a successful response compared with 13 in the lidocaine group (P = 0·007). CONCLUSION: Entrapped branches of intercostal nerves may contribute to the clinical picture in some patients with chronic abdominal pain. Pain reduction following local infiltration in these patients was based on an anaesthetic mechanism and not on a placebo or a mechanical (volume) effect. REGISTRATION NUMBER: NTR2016 (Nederlands Trial Register; http://www.trialregister.nl).

Effect of obstetric team training on team performance and medical technical skills: a randomised controlled trial.

OBJECTIVE: To determine whether obstetric team training in a medical simulation centre improves the team performance and utilisation of appropriate medical technical skills of healthcare professionals. DESIGN: Cluster randomised controlled trial. SETTING: The Netherlands. SAMPLE: The obstetric departments of 24 Dutch hospitals. METHODS: The obstetric departments were randomly assigned to a 1-day session of multiprofessional team training in a medical simulation centre or to no such training. Team training was given with high-fidelity mannequins by an obstetrician and a communication expert. More than 6 months following training, two unannounced simulated scenarios were carried out in the delivery rooms of all 24 obstetric departments. The scenarios, comprising a case of shoulder dystocia and a case of amniotic fluid embolism, were videotaped. The team performance and utilisation of appropriate medical skills were evaluated by two independent experts. MAIN OUTCOME MEASURES: Team performance evaluated with the validated Clinical Teamwork Scale (CTS) and the employment of two specific obstetric procedures for the two clinical scenarios in the simulation (delivery of the baby with shoulder dystocia in the maternal all-fours position and conducting a perimortem caesarean section within 5 minutes for the scenario of amniotic fluid embolism). RESULTS: Seventy-four obstetric teams from 12 hospitals in the intervention group underwent teamwork training between November 2009 and July 2010. The teamwork performance in the training group was significantly better in comparison to the nontraining group (median CTS score: 7.5 versus 6.0, respectively; P = 0.014). The use of the predefined obstetric procedures for the two clinical scenarios was also significantly more frequent in the training group compared with the nontraining group (83 versus 46%, respectively; P = 0.009). CONCLUSIONS: Team performance and medical technical skills may be significantly improved after multiprofessional obstetric team training in a medical simulation centre.

Gallbladder cancer, a vanishing disease?

OBJECTIVE: Gallbladder cancer (GBC) is a rare gastrointestinal malignancy. A retrospective population-based study was conducted to evaluate trends in incidence, treatment, and outcome of GBC in the latter three decades in the south of the Netherlands. METHODS: All patients diagnosed with GBC diagnosed in the Dutch Eindhoven Cancer Registry area between 1975 and 2008 were included (n = 659). Trend analyses were conducted for treatment and survival. RESULTS: During this time period, standardized incidence in females and males plummeted from 4.5 to 0.7 and from 2.0 to 0.4 per 100,000 inhabitants, respectively. Resection rates decreased from 74.3 to 53.4 %. Chemotherapy and radiotherapy rates did not change and were used sparingly. Five-year survival remained stable (10 %) over time. CONCLUSION: The age-standardized incidence of GBC declined drastically over the last three decades. An increasing number of early cholecystectomies for gallstones may play a role. Parallel to the decreasing incidence of stomach cancer, the effective treatment of Helicobacter pylori may also have resulted in a lowered incidence of GBC.

Risk factors for conversion during laparoscopic cholecystectomy - experiences from a general teaching hospital.

BACKGROUND AND AIMS: Laparoscopic cholecystectomy (LC) is the gold standard for treating symptomatic cholelithiasis. Conversion, however, is sometimes necessary. The aim of this study was to determine predictive factors of conversion in patients undergoing LC for various indications in elective and acute settings in a general teaching hospital. MATERIAL AND METHODS: A retrospective analysis was performed on 972 consecutive patients who underwent a laparoscopic cholecystectomy in Máxima Medical Centre in Veldhoven, the Netherlands, from January 2000 till January 2006. Recorded data were sex, age, indication for LC, conversion to open cholecystectomy, reason for conversion, performing surgeon, co-morbidity, type of complication, length of hospital stay and 30-day mortality. RESULTS: Conversion to open cholecystectomy was performed in 121 patients (12%). The most frequent reasons for conversion were infiltration/fibrosis of Calot's triangle (30%) and adhesions (27%). In the multivariate analyses male gender (OR 1.67, 95% CI 1.07-2.59), age >65 years (OR 2.10, 95% CI 1.32-3.34), acute cholecystitis (OR 11.8, 95% CI 6.98-20.1), recent acute cholecystitis (OR 4.71, 95% CI 2.42-9.18) and recent obstructive jaundice (OR 20.6, 95% CI 4.52-94.1) were independent predictive factors for conversion. CONCLUSIONS: Male gender, age >65 years, (recent) acute cholecystitis and recent obstructive jaundice are independent predictive risk factors for conversion. By appreciating these risk factors for conversion, preoperative patient counselling can be improved.

Management of anterior cutaneous nerve entrapment syndrome in a cohort of 139 patients.

OBJECTIVE: Anterior cutaneous nerve entrapment syndrome (ACNES) is generally neglected as a source of chronic abdominal pain. The aim of this study was to evaluate the efficacy of a diagnostic workup protocol and treatment regimen in patients with suspected ACNES. METHODS: A cohort of all consecutive patients presenting with chronic abdominal pain suggestive of ACNES between 2003 and 2008 was evaluated retrospectively. Patients were offered a single diagnostic injection of 1% lidocaine into the trigger point followed by subsequent therapeutic injections including corticosteroids. If pain was refractory, an anterior neurectomy was performed. Pain scores were done using a visual analog scale for evaluation of the injection regimen and Verbal Rating Scale (1-5) for long-term efficacy. RESULTS: A total of 139 patients with suspected ACNES (77% women, mean age 47 ± 17 years) were evaluated. Eighty-one percent (n = 94) demonstrated a visual analog scale reduction of at least 50% after the first injection. Some 33% (n = 44) remained permanently pain-free after injection therapy only. Sixty-nine patients underwent a neurectomy, which was successful in 49 (71%). Long-term efficacy revealed in 71% (very) satisfying visual rating scale (1-2) results, whereas an additional 9% reported attenuated levels of pain (visual rating scale 3). CONCLUSION: A regimen of consecutive local trigger point injections is effective in one-thirds of patients with ACNES. Surgical neurectomy is effective in about two-thirds of the injection regimen refractory patients. Eighty percent of the entire ACNES population reports total or substantial pain relief on the long term.

Normalized spectral power of fetal heart rate variability is associated with fetal scalp blood pH.

BACKGROUND: Spectral power of fetal heart rate variability is related to fetal condition. Previous studies found an increased normalized low frequency power in case of severe fetal acidosis. AIMS: To analyze whether absolute or normalized low or high frequency power of fetal heart rate variability is associated with fetal scalp blood pH. STUDY DESIGN: Prospective cohort study, performed in an obstetric unit of a tertiary care teaching hospital. SUBJECTS: Consecutive singleton term fetuses in cephalic presentation that underwent one or more scalp blood samples, monitored during labour using ST-analysis of the fetal electrocardiogram. Ten-minute continuous beat-to-beat fetal heart rate segments, preceding the scalp blood measurement were used. OUTCOME MEASURES: Absolute and normalized spectral power in the low frequency band (0.04-0.15 Hz) and in the high frequency band (0.4-1.5 Hz). RESULTS: In total 39 fetal blood samples from 30 patients were studied. We found that normalized low frequency and normalized high frequency power of fetal heart rate variability is associated with fetal scalp blood pH. The estimated ß of normalized low frequency power was -0.37 (95% confidence interval -0.68 to -0.06) and the relative risk was 0.69 (95% confidence interval 0.51-0.94). The estimated ß of normalized high frequency power was 0.33 (95% confidence interval 0.01-0.65) and the relative risk was 1.39 (95% confidence interval 1.01-1.92). CONCLUSIONS: Normalized low and normalized high frequency power of fetal heart rate variability is associated with fetal scalp blood pH.