Objectives: To describe the incidence and outcomes of pulmonary oedema in women with severe maternal outcome during childbirth and identify possible modifiable factors through audit.Methods: All... Show moreObjectives: To describe the incidence and outcomes of pulmonary oedema in women with severe maternal outcome during childbirth and identify possible modifiable factors through audit.Methods: All women with severe maternal outcome (maternal deaths or near misses) who were referred to Tygerberg referral hospital from health facilities in Metro East district, South Africa, during 2014-2015 were included. Women with severe maternal outcome and pulmonary oedema during pregnancy or childbirth were evaluated using three types of critical incident audit: criterion-based case review by one consultant gynaecologist, monodisciplinary critical incident audit by a team of gynaecologists, multidisciplinary audit with expert review from anaesthesiologists and cardiologists.Results: Of 32,161 pregnant women who gave birth in the study period, 399 (1.2%) women had severe maternal outcome and 72/399 (18.1%) had pulmonary oedema with a case fatality rate of 5.6% (4/72). Critical incident audit demonstrated that pre-eclampsia/HELLP-syndrome and chronic hypertension were the main conditions underlying pulmonary oedema (44/72, 61.1%). Administration of volumes of intravenous fluids in already sick women, undiagnosed underlying cardiac illness, administration of magnesium sulphate as part of pre-eclampsia management and oxytocin for augmentation of labour were identified as possible contributors to the pathophysiology of pulmonary oedema. Women-related factors (improved antenatal care attendance) and health care-related factors (earlier diagnosis and management) would potentially have improved maternal outcome.Conclusions: Although pulmonary oedema in pregnancy is rare, among women with severe maternal outcome a considerable proportion had pulmonary oedema (18.1%). Audit identified options for prevention of pulmonary oedema and improved outcome. These included early detection and management of preeclampsia with close monitoring of fluid intake and cardiac evaluation in case of suspected pulmonary oedema. Therefore, a multidisciplinary clinical approach is recommended. Show less
Rosman, A.N.; Dillen, J. van; Zwart, J.; Overtoom, E.; Schaap, T.; Bloemenkamp, K.; Akker, T. van den 2022
Background and Aims: To analyze outcomes of nationwide local audits of uterine rupture to draw lessons for clinical care. Methods: Descriptive cohort study. Critical incident audit sessions within... Show moreBackground and Aims: To analyze outcomes of nationwide local audits of uterine rupture to draw lessons for clinical care. Methods: Descriptive cohort study. Critical incident audit sessions within all local perinatal cooperation groups in the Netherlands. Women who sustained uterine rupture between January 1st, 2017 and December 31st, 2019. Main Outcome Measures: Improvable factors, recommendations, and lessons learned for clinical care. Women's case histories were discussed in multidisciplinary perinatal audit sessions. Participants evaluated care against national and local clinical guidelines and common professional standards to identify improvable factors. Cases and outcomes were registered in a nationwide database. Results: One hundred and fourteen women who sustained uterine rupture were discussed in local perinatal audit sessions by 40-60 participants on average: A total of 111 (97%) were multiparous of whom 107 (94%) had given birth by cesarean section in a previous pregnancy. The audit revealed 178 improvable factors and 200 recommendations. Six percent (N = 11) of the improvable factors were identified as very likely and 18% (N = 32) as likely to have a relationship with the outcome or occurrence of uterine rupture. Improvable factors were related to inadequate communication, absent, or unclear documentation, delay in diagnosing the rupture, and suboptimal management of labor. Speak up in case a suspicion arises, escalating care by involving specialist obstetricians, addressing the importance of accurate documentation, and improving training related to fetal monitoring were the most frequent recommendations and should be topics for team (skills and drills) training. Conclusions: Through a nationwide incident audit of uterine rupture, we identified improvable factors related to communication, documentation, and organization of care. Lessons learned include "speaking up," improving the transfer of information and team training are crucial to reduce the incidence of uterine rupture. Show less
Objectives To determine prospectively the sources of risk of non-sterility during aseptic handling and to quantify the risks of each of these sources. Methods A risk assessment (RA) of non... Show moreObjectives To determine prospectively the sources of risk of non-sterility during aseptic handling and to quantify the risks of each of these sources. Methods A risk assessment (RA) of non-sterility according to Failure Mode and Effect Analysis was executed by a multidisciplinary team of (hospital) pharmacists and technicians, a consultant experienced in aseptic processing and an independent facilitator. The team determined the sources of risk of non-sterility, a 5 point scale for severity, occurrence and detection, and risk acceptance levels. Input about general applied risk reduction was collected by audits in 10 hospital pharmacies. The results of these audits were used for determining the remaining risks. The results, as well as scientific information and the experience of the team members, was used to determine scores for severity, occurrence and detection. Results Multiplying the scores for severity, occurrence and detection results in the risk prioritisation number (RPN) which is a relative value of the remaining risks of non-sterility for each source. Incorrect disinfection techniques of non-sterile materials and the chances of touching critical spots were estimated as the greatest risks. The risk of non-sterility via the airborne route was low. RPN values were helpful in prioritising measures for additional risk reduction (this will be described in an accompanying article). Conclusion The RA, described here, was a systematic survey related to all sources of risk of non-sterility during aseptic handling. The determined RPN values were helpful in prioritising measures for additional risk reduction. Show less
Objectives To determine prospectively the risk reducing measures of non-sterility during aseptic handling and to develop a method for prioritising these measures. Methods In the first part of this... Show moreObjectives To determine prospectively the risk reducing measures of non-sterility during aseptic handling and to develop a method for prioritising these measures. Methods In the first part of this series of articles, we identified all sources of risk which could contaminate a product during aseptic handling, and calculated the remaining risks of non-sterility using a risk assessment (RA) model. We concluded that additional research of some risk sources was needed before risk control (RC) could be executed on all risk sources. The chances of technical problems with a laminar airflow cabinet or safety cabinet (LAF/SC) were collected from 10 hospital pharmacies using a questionnaire. The chances of blocking first air were examined by airflow visualisation (smoke studies). For checking the way of working during aseptic handling, a checklist for an audit was developed. Risk control was executed by a multidisciplinary team of (hospital) pharmacists and technicians, a consultant experienced in aseptic processing and an independent facilitator. They determined the risk reducing measures for each source of risk and the influence of these measures on the remaining risk (expressed as risk prioritisation number). Results The chances of defects of the LAF/SC were low. Airflow visualisation is a sensible method to find the correct location of materials and equipment inside the LAF/SC and to detect a way of working without blocking first air on critical spots. Audits will provide valuable information about the way aseptic handling is executed and the remaining risks as a consequence. The risk of non-sterility caused by needle or spike contact with critical spots of vials and ampoules (stopper or ampoule neck), blocking first air under downflow and touching critical spots cannot be eliminated completely. Conclusion The RA/RC model shows the impact of risk reducing measures on the probability of non-sterility during aseptic handling. The calculated risk prioritisation numbers are helpful in prioritising these measures. Audits result in risk reduction for nearly all sources of risk. Show less
Dirikgil, E.; Jonker, J.T.; Tas, S.W.; Verburgh, C.A.; Soonawala, D.; Hak, A.E.; ... ; Arthritis Res Collaboration Hub AR 2021
Introduction: Managing complex and rare systemic autoimmune diseases such as antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) can be challenging and is often accompanied by... Show moreIntroduction: Managing complex and rare systemic autoimmune diseases such as antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) can be challenging and is often accompanied by undesirable variations in clinical practice. Adequate understanding of clinical practice can help identify essential issues to improve the care for AAV patients. Therefore, we studied the real-life management and outcomes of AAV patients in the Netherlands.Methods: In this cohort study, we investigated clinical practice in university and nonuniversity teaching hospitals with respect to patients with a clinical diagnosis of AAV. We retrospectively collected clinical data encompassing clinical variables, medication details, and outcome parameters.Results: Data of 230 AAV patients were collected in 9 Dutch hospitals. Of these, 167 patients (73%) were diagnosed with granulomatosis with polyangiitis, 54 (24%) with microscopic polyangiitis and 9 (4%) with eosinophilic granulomatosis with polyangiitis. One hundred sixty-six patients (72%) had generalized disease. The median year of diagnosis was 2013 (range 1987-2018). Besides steroids, oral cyclophosphamide was the most used drug (50%) for induction therapy and azathioprine (68%) for maintenance therapy. Adverse outcomes were major infections in 35%, major relapses in 23%, malignancy in 10%, major cardiovascular events in 8%, and end-stage renal disease in 7%.Conclusion: Oral cyclophosphamide was the most frequently used induction therapy, azathioprine for maintenance therapy; over time, the use of rituximab is increasingly employed. Major infection and relapses are the most prevalent adverse outcomes. This audit resulted in important indicators for treatment of AAV patients that can be implemented for future, national audits to improve the outcomes of AAV patients. Show less
Objectives To describe the application of the model described in part A and part B of this series of articles for risk assessment (RA) and risk control (RC) of non-sterility during aseptic handling... Show moreObjectives To describe the application of the model described in part A and part B of this series of articles for risk assessment (RA) and risk control (RC) of non-sterility during aseptic handling. The model was applied in nine hospital pharmacies. Methods The starting point was an audit of each hospital pharmacy. The determined risk reduction and remaining risks were entered into a risk assessment model. The corresponding risk prioritisation numbers (RPNs) for each source of risk were calculated and these values were summed up to a cumulative RPN. Subsequently, all hospital pharmacies started an improvement programme, using the risk assessment as input. Results of aseptic process simulation (APS) and microbiological monitoring (MM) were also collected. The participants were informed about their progress of risk reduction and results of APS and MM during the study period. At the end of the study (about 4 years after the start), a final assessment was executed by using a checklist with risk reducing measures for each source of risk. Additional risk reduction and remaining risks were put in an RA and RC template and corresponding RPN values and a new cumulative RPN were determined. Results At the start of the study differences in cumulative RPN values were relatively small (from 630 to 825). At the end they were relatively great (from 230 to 725), which illustrates a different sense of urgency for reducing the risk of non-sterility. Of all the risk reducing measures, a yearly audit of all operators had the greatest impact on reducing the risk of non-sterility. Except for glove prints, there was no correlation between process improvement (lower cumulative RPN) and results of microbiological controls. Conclusion A systematic and science-based reduction of the risks of non-sterility can be done by using a checklist with risk reducing measures and an RA & RC template. Prospectively, the relevance of each risk reducing measure can be demonstrated by RPN calculations. Microbiological controls are an important part of the overall assurance of product quality. However, the results are less useful for assessing the risk of non-sterility. Show less
Geze, S.; Tura, A.K.; Fage, S.G.; Akker, T. van den 2021
Objective The rates of caesarean section (CS) in Ethiopian private hospitals are high compared with those in public facilities, and there are limited descriptions of groups of women contributing to... Show moreObjective The rates of caesarean section (CS) in Ethiopian private hospitals are high compared with those in public facilities, and there are limited descriptions of groups of women contributing to these high rates. The objective of this study was to describe the groups contributing to increased CS rates using the Robson classification in two major private hospitals in eastern Ethiopia. Design Cross-sectional study. Setting Two major private hospitals in eastern Ethiopia. Participants All women who gave birth from 9 January 2019 to 8 January 2020 in two major private hospitals in eastern Ethiopia. Primary and secondary outcome measures The primary outcome was the Robson 10 Group Classification System. The secondary outcome was indication for CS as recorded in the medical files. Results Of 1203 births in both hospitals combined during the study period, 415 (34.5%) were by CS. Women with a uterine scar due to previous CS (group 5), single cephalic term multiparous women in spontaneous labour (group 3) and single cephalic term nulliparous women in spontaneous labour (group 1) were the leading groups contributing 33%, 27.5% and 17.1%, respectively. The leading documented indications were fetal compromise (29.4%), previous CS (27.2%) and obstructed labour (12.3%). Conclusion More than three-fourths of CS were performed among Robson groups 5, 3 and 1, indicating inadequate trial of labour after CS or management of labour among relatively low-risk groups (3 and 1). Improving management of spontaneous labour and strengthening clinical practice around safely providing the option of vaginal birth after CS practice are strategies required to reduce the high CS rates in these private facilities. Show less
Objective Congenital heart defects (CHD) are still missed frequently in prenatal screening programs, which can result in severe morbidity or even death. The aim of this study was to evaluate the... Show moreObjective Congenital heart defects (CHD) are still missed frequently in prenatal screening programs, which can result in severe morbidity or even death. The aim of this study was to evaluate the quality of fetal heart images, obtained during the second-trimester standard anomaly scan (SAS) in cases of CHD, to explore factors associated with a missed prenatal diagnosis. Methods In this case-control study, all cases of a fetus born with isolated severe CHD in the Northwestern region of The Netherlands, between 2015 and 2016, were extracted from the PRECOR registry. Severe CHD was defined as need for surgical repair in the first year postpartum. Each cardiac view (four-chamber view (4CV), three-vessel (3V) view and left and right ventricular outflow tract (LVOT, RVOT) views) obtained during the SAS was scored for technical correctness on a scale of 0 to 5 by two fetal echocardiography experts, blinded to the diagnosis of CHD and whether it was detected prenatally. Quality parameters of the cardiac examination were compared between cases in which CHD was detected and those in which it was missed on the SAS. Regression analysis was used to assess the association of sonographer experience and of screening-center experience with the cardiac examination quality score.Results A total of 114 cases of isolated severe CHD at birth were analyzed, of which 58 (50.9%) were missed and 56 (49.1%) were detected on the SAS. The defects comprised transposition of the great arteries (17%), aortic coarctation (16%), tetralogy of Fallot (10%), atrioventricular septal defect (6%), aortic valve stenosis (5%), ventricular septal defect (18%) and other defects (28%). No differences were found in fetal position, obstetric history, maternal age or body mass index (BMI) or gestational age at examination between missed and detected cases. Ninety-two cases had available cardiac images from the SAS. Compared with the detected group, the missed group had significantly lower cardiac examination quality scores (adequate score (>= 12) in 32% vs 64%; P=0.002), rate of proper use of magnification (58% vs 84%; P=0.01) and quality scores for each individual cardiac plane (4CV (2.7 vs 3.9; P<0.001), 3V view (3.0 vs 3.8; P=0.02), LVOT view (1.9 vs 3.3; P<0.001) and RVOT view (1.9 vs 3.3; P<0.001)). In 49% of missed cases, the lack of detection was due to poor adaptational skills resulting in inadequate images in which the CHD was not clearly visible; in 31%, the images showed an abnormality (mainly septal defects and aortic arch anomalies) which had not been recognized at the time of the scan; and, in 20%, the cardiac planes had been obtained properly but showed normal anatomy. Multivariate regression analysis showed that the volume of SAS performed per year by each sonographer was associated significantly with quality score of the cardiac examination.Conclusions A lack of adaptational skills when performing the SAS, as opposed to circumstantial factors such as BMI or fetal position, appears to play an important role in failure to detect CHD prenatally. The quality of the cardiac views was inadequate significantly more often in undetected compared with detected cases. Despite adequate quality of the images, CHD was not recognized in 31% of cases. A high volume of SAS performed by each sonographer in a large ultrasound center contributes significantly to prenatal detection. In 20% of undetected cases, CHD was not visible even though the quality of the images was good. (c) 2019 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of the International Society of Ultrasound in Obstetrics and Gynecology. Show less
Breugom, A.J.; Boelens, P.G.; Broek, C.B.M. van den; Cervantes, A.; Cutsem, E. van; Schmoll, H.J.; ... ; Velde, C.J.H. van de 2014
