Using simulation-based training during hospital relocation: a controlled intervention study.

BACKGROUND: During hospital relocations, it is important to support healthcare professionals becoming familiar with new settings. Simulation-based training seems promising and in situ simulation has been suggested as a beneficial educational tool to prepare healthcare professionals for relocation. This study aimed to investigate the impact of a simulation-based training intervention on health professionals´ readiness to work in their new environment, as well as investigate sick leave before and after relocation. METHODS: The study was a controlled intervention study implemented at a university hospital in Denmark. Simulation was used to prepare employees for workflows prior to relocation. Before relocation, 1199 healthcare professionals participated in the in situ simulation-based training program. Questionnaires on readiness to perform were distributed to participants at pre-, post-, and follow-up (6 months) measurement. In addition, data on participants' sick leave was gathered from a business intelligence portal. To compare dependent and independent groups, paired and unpaired t tests were performed on mean score of readiness to perform and sick leave. RESULTS: Compared to the control group, healthcare professionals participating in the intervention felt significantly more ready to work in a new hospital environment. As a measure of psychological wellbeing, register data indicated no difference in sick leave, when comparing intervention and control groups before and after participating in the in situ simulation-based training program. CONCLUSIONS: Healthcare professionals felt significantly more ready to work in a new environment, after participating in the in situ simulation-based training program, indicating that the intervention supported healthcare professionals during relocations. This may mitigate feelings of uncertainty; however, further research is needed to explore such effects. TRIAL REGISTRATION: The study was approved by The Regional Ethics Committee (no. 1-16-02-222-22).

Patient safety culture improvements depend on basic healthcare education: a longitudinal simulation-based intervention study at two Danish hospitals.

BACKGROUND: A growing body of evidence supports the existence of an association between patient safety culture (PSC) and patient outcomes. PSC refers to shared perceptions and attitudes towards norms, policies and procedures related to patient safety. Existing literature shows that PSC varies among health professionals depending on their specific profession and specialty. However, these studies did not investigate whether PSC can be improved. This study investigates whether length of education is associated with improvements in PCS following a simulation intervention. METHODS: From April 2017 to November 2018, a cross-sectional intervention study was conducted at two regional hospitals in Denmark. Two groups with altogether 1230 health professionals were invited to participate. One group included nurses, midwives and radiographers; the other group included doctors. A train-the-trainer intervention approach was applied consisting of a 4-day simulation instructor course that emphasised team training, communication and leadership. Fifty-three healthcare professionals were trained as instructors. After the course, instructors performed in situ simulation in their own hospital environment. OUTCOMES: The Safety Attitude Questionnaire (SAQ), which has 6 dimensions and 32 items, was used to collect main outcome variables. All employees from both groups were surveyed before the intervention and again four and nine months after the intervention. RESULTS: Mean baseline scores were higher among doctors than among nurses, midwives and radiographers for all SAQ dimensions. At the second follow-up, four of six dimensions improved significantly (p ≤ 0.05) among nurses, midwives and radiographers, whereas no dimensions improved significantly among doctors. CONCLUSION: Over time, nurses, midwives and radiographers improved more in PSC attitudes than doctors did.

Simulation-Based Emergency Team Training in Pediatrics: A Systematic Review.

OBJECTIVES: The rare event of handling critically ill children often challenge the emergency care team. Several studies have investigated effects of simulation-based team training to prepare for such events, but the body of evidence remains to be compiled. We performed a systematic review of the effects of simulation-based team training on clinical performance and patient outcome. METHODS: From a search of MEDLINE, Embase, CINAHL, and Cochrane Library, we included studies of team training in emergency pediatric settings with reported clinical performance and patient outcomes. We extracted data using a predefined template and assessed risk of bias using the Cochrane risk-of-bias tool for randomized trials 2.0 and the Newcastle Ottawa Quality Assessment Scale. RESULTS: We screened 1926 abstracts and included 79 studies. We identified 15 studies reporting clinical health care professional performance or patient outcomes. Four studies reported survival data, 5 reported time-critical clinical events, 5 reported adherence to guidelines, checklists or tasks, and 2 reported on airway management. Randomized studies revealed improved team performance in simulated reevaluations 2 to 6 months after intervention. A meta-analysis was impossible because of heterogeneous interventions and outcomes. Most included studies had significant methodological limitations. CONCLUSIONS: Pediatric simulation-based team training improves clinical performance in time-critical tasks and adherence to guidelines. Improved survival was indicated but not concluded because of high risk of bias. Team performance and technical skills improved for at least 2 to 6 months. Future research should include longer-term measures of skill retention and patient outcomes or clinical measures of treatment quality whenever possible.

Glycemic Control in Pregnancies Complicated by Pre-Existing Diabetes Mellitus and Congenital Malformations: A Danish Population-Based Study.

PURPOSE: To study the occurrence of major congenital abnormalities in children of women with type 1 and type 2 diabetes and investigate the association between glycated haemoglobin (HbA1c) and major congenital malformations according to type 1 diabetes and type 2 diabetes separately. PATIENTS AND METHODS: In this register-based study, all singletons born alive from January 1, 2000 to December 31, 2015 in the North Denmark and Central Denmark regions of Denmark and their mothers were included. We used data from Danish health registers and the LABKA database. Logistic regression models were used to compute crude and adjusted prevalence odds ratios (cORs and aORs) with 95% confidence intervals (CIs) for major congenital malformations overall and for subtypes, by type of maternal pre-existing diabetes and HbA1c levels. RESULTS: Among 314,245 infants included, 2020 (0.64%) had mothers with type 1 diabetes and 498 (0.16%) had mothers with type 2 diabetes. We found an aOR of 2.9 (95% CI: 2.5, 3.5) and 1.9 (95% CI: 1.3; 2.8) for major malformations for type 1 and type 2 diabetes, respectively. The highest occurrence was seen for major congenital heart diseases, but we also observed higher occurrence of several other non-cardiac malformations. For both type 1 and type 2 diabetes, the prevalence of major congenital malformations increased with higher levels of maternal HbA1c with no safe threshold level. Mothers with type 1 diabetes had higher risks than those without diabetes irrespective of HbA1c, and women with HbA1c levels ≥9.5% had 8 times the odds of major congenital malformations [aOR 8.7 (95% CI: 5.4; 14.5)]. CONCLUSIONS: The prevalence of major congenital malformations progressively increased with poorer glycemic control during pregnancy, with no obvious safe threshold level, for both type 1 and type 2 diabetes.

Simulation-Based Neonatal Resuscitation Team Training: A Systematic Review.

CONTEXT: Several neonatal simulation-training programs have been deployed during the last decade, and in a growing number of studies, researchers have investigated the effects of simulation-based team training. This body of evidence remains to be compiled. OBJECTIVE: We performed a systematic review of the effects of simulation-based team training on clinical performance and patient outcome. DATA SOURCES: Medline, Embase, Cumulative Index to Nursing and Allied Health Literature, and the Cochrane Library. STUDY SELECTION: Two authors included studies of team training in critical neonatal situations with reported outcomes on clinical performance and patient outcome. DATA EXTRACTION: Two authors extracted data using a predefined template and assessed risk of bias using the Cochrane risk-of-bias tool 2.0 and the Newcastle-Ottawa quality assessment scale. RESULTS: We screened 1434 titles and abstracts, evaluated 173 full texts for eligibility, and included 24 studies. We identified only 2 studies with neonatal mortality outcomes, and no conclusion could be reached regarding the effects of simulation training in developed countries. Considering clinical performance, randomized studies revealed improved team performance in simulated re-evaluations 3 to 6 months after the intervention. LIMITATIONS: Meta-analysis was impossible because of heterogenous interventions and outcomes. Kirkpatrick's model for evaluating training programs provided the framework for a narrative synthesis. Most included studies had significant methodologic limitations. CONCLUSIONS: Simulation-based team training in neonatal resuscitation improves team performance and technical performance in simulation-based evaluations 3 to 6 months later. The current evidence was insufficient to conclude on neonatal mortality after simulation-based team training because no studies were available from developed countries. In future work, researchers should include patient outcomes or clinical proxies of treatment quality whenever possible.

Physical activity during pregnancy and intelligence in sons; A cohort study.

The purpose was to examine the association between exercise during pregnancy and intelligence score in offspring. We analyzed data from 4008 women from the Aarhus Birth Cohort, Aarhus University Hospital, Denmark, recruited during pregnancy from July 1989 to November 1991 and their sons who were registered at conscription at 17-20 years of age. The women gave information by self-administered questionnaires during the first trimester including leisure-time physical activity and weekly hours of sport. This information was linked to the sons' measures of intelligence by Børge Priens test scores from the Danish Conscription Registry. Only sons were included since very few women register at conscription in Denmark. The main outcome measure was the Børge Priens test score as a continuous variable and with a low score defined as <10% of the population score. Analyses were adjusted for maternal body mass index, years in school, and smoking. Sons of women with light and moderate to heavy leisure-time physical activity had lower risk of having a low intelligence score compared with sons of women with sedentary activity: adjusted odds ratio (aOR) 0.66 (95% CI 0.49;0.88) and 0.46 (95% CI 0.23;0.93), respectively. Furthermore, sons of women engaged in sports had lower risk of a low intelligence score: aOR 0.50 (95% CI 0.30; 0.83) for 1-2 h/wk and 0.62 (95% CI 0.35; 1.10) for ≥3 h/wk compared with no weekly sports activity. In conclusion, a higher level of physical activity during pregnancy was associated with a lower risk of low intelligence score in early adulthood in sons.

Parental subfertility and hypospadias and cryptorchidism in boys: results from two Danish birth cohorts.

OBJECTIVE: To study if parental subfertility is related to the occurrence of the male genital anomalies, cryptorchidism and hypospadias. DESIGN: Population-based cohort study. SETTING: Not applicable. PATIENT(S): A total of 80,220 singleton boys and their mothers from the Danish National Birth Cohort and the Aarhus Birth Cohort. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): The two congenital anomalies; cryptorchidism and hypospadias, registered within the Danish National Patient Register up until December 31, 2012. RESULT(S): By means of Cox regression analyses, we found no associations between waiting time-to-pregnancy (TTP) and cryptorchidism or hypospadias among those who conceived spontaneously. The highest hazard ratio for cryptorchidism was seen among boys of couples with a TTP>12 months who conceived after fertility treatment (adjusted hazard ratio [aHR] 1.19, 95% confidence interval 0.92-1.55). For hypospadias, we found that boys of couples with a TTP>12 months who conceived after fertility treatment, had a 71% higher risk of hypospadias (aHR 1.71, [95% confidence interval 1.24-3.36]) as compared with boys of couples with a TTP<5 months. CONCLUSION(S): The findings from this study showed that boys of couples with TTP>12 months who conceived after fertility treatment, had a higher occurrence of hypospadias than boys conceived spontaneously of couples with a short TTP. Among those who conceived spontaneously, TTP was not associated with hypospadias or cryptorchidism. These findings indicate that fertility treatment or severity of subfertility is related to hypospadias.

Hypertensive Disorders of Pregnancy and Genital Anomalies in Boys: A Danish Nationwide Cohort Study.

BACKGROUND: Although congenital abnormalities in the male reproductive tract are common, their causes remain poorly understood. We studied associations between hypertensive disorders of pregnancy (pregestational hypertension, gestational hypertension, and preeclampsia) and the genital anomalies, cryptorchidism (undescended testes), and hypospadias (ventrally displaced urethral meatus). METHODS: We established a population of 1,073,026 Danish boys born alive between 1 January 1978 and 31 December 2012. By means of Cox regression analyses, we estimated hazard ratios with 95% confidence intervals for cryptorchidism and hypospadias according to type and severity of hypertensive disorder. Further, we used restricted cubic spline analyses to investigate the association between gestational age at onset of severe and moderate preeclampsia and the two genital anomalies. RESULTS: We found associations between pregestational hypertension and cryptorchidism (HR: 1.3; 95% CI = 1.1, 1.6) and hypospadias (HR: 1.7; 95% CI = 1.3, 2.3), whereas gestational hypertension was only associated with cryptorchidism (HR: 1.2; 95% CI = 1.1, 1.4). Boys of mothers with preeclampsia had the highest occurrence of cryptorchidism and hypospadias, increasing with preeclampsia severity. Women with HELLP syndrome faced the highest risk of having a child with both cryptorchidism (HR: 2.1; 95% CI = 1.4, 3.2) and hypospadias (HR: 3.9; 95% CI = 2.5, 6.1). Further, the occurrence increased with early onset of preeclampsia diagnosis. CONCLUSIONS: These findings support the hypotheses that preeclampsia and genital anomalies share common etiologic factors and that placental dysfunction and androgen deficiency in early pregnancy are important in the etiology of male genital anomalies.

Lifestyle in pregnancy and cryptorchidism in sons: a study within two large Danish birth cohorts.

PURPOSE: Cryptorchidism is the most frequent congenital malformation in boys and is associated with low sperm count, infertility and testicular cancer. Unhealthy maternal lifestyle during pregnancy such as smoking, high prepregnancy body mass index (BMI) as well as alcohol and caffeine intake may constitute possible risk factors for cryptorchidism, but results from the few previous studies are conflicting. We aimed to explore the association between maternal lifestyle factors and occurrence of cryptorchidism in sons. PATIENTS AND METHODS: The Danish National Birth Cohort and the Aarhus Birth Cohort provided information on maternal lifestyle from early pregnancy. Data were linked to several Danish health registers, multiple imputation was used to handle missing data and Cox proportional hazards models were used to adjust for potential confounders. RESULTS: In total, 85,923 boys were included, and of them, 2.2% were diagnosed with cryptorchidism. We observed the strongest associations between maternal tobacco smoking and prepregnancy BMI and cryptorchidism. Sons of women who smoked 10-14 cigarettes/day had the highest hazard ratio (HR) for cryptorchidism (1.37; 95% CI: 1.06-1.76), and for maternal BMI ≥30 kg/m2, the HR was 1.32 (95% CI: 1.06-1.65). Binge drinking was associated with an HR <1, if the women had one or two episodes in pregnancy (HR: 0.81; 95% CI: 0.67-0.98). Average maternal alcohol intake and caffeine intake during pregnancy were not significantly associated with a higher occurrence of cryptorchidism detected at birth or later in life. CONCLUSION: Maternal tobacco smoking, overweight and obesity in pregnancy were associated with higher occurrence of cryptorchidism in boys in this study.

Maternal Diabetes Mellitus and Genital Anomalies in Male Offspring: A Nationwide Cohort Study in 2 Nordic Countries.

BACKGROUND: Pre-existing diabetes has been associated with an increased risk of congenital malformations overall, but studies on genital anomalies in boys are conflicting and possible causal mechanisms are not well understood. Previous studies have mainly assessed pregestational and gestational diabetes in combination. Yet considering the vulnerable time windows for the genital anomalies, associations could well differ between types of diabetes and between the 2 genital anomalies and we therefore aimed to study this further. METHODS: A population-based cohort study of 2,416,246 singleton live-born boys from Denmark (1978-2012) and Sweden (1987-2012) was carried out using Danish and Swedish register-based data. Using Cox regression models, we estimated hazard ratios for hypospadias and cryptorchidism according to maternal diabetes. We considered type and severity of diabetes, as well as timing of diagnosis in relation to birth. RESULTS: Pregestational type 1 diabetes was associated with a higher risk of both genital anomalies. The highest risks were seen for boys of mothers with diabetic complications (hazard ratio for hypospadias = 2.33 [95% confidence interval, 1.48, 3.66] and hazard ratio for cryptorchidism = 1.92 [95% confidence interval, 1.39, 2.65]). Gestational diabetes was associated with slightly increased risks of both genital anomalies. CONCLUSIONS: These results are consistent with the hypothesis that poor glycemic control may interfere with fetal genital development in the critical early period of organogenesis. Given the widespread and increasing occurrence of diabetes, these results are of public health importance.

Association of light-to-moderate alcohol drinking in pregnancy with preterm birth and birth weight: elucidating bias by pooling data from nine European cohorts.

Women who drink light-to-moderately during pregnancy have been observed to have lower risk of unfavourable pregnancy outcomes than abstainers. This has been suggested to be a result of bias. In a pooled sample, including 193 747 live-born singletons from nine European cohorts, we examined the associations between light-to-moderate drinking and preterm birth, birth weight, and small-for-gestational age in term born children (term SGA). To address potential sources of bias, we compared the associations from the total sample with a sub-sample restricted to first-time pregnant women who conceived within six months of trying, and examined whether the associations varied across calendar time. In the total sample, drinking up to around six drinks per week as compared to abstaining was associated with lower risk of preterm birth, whereas no significant associations were found for birth weight or term SGA. Drinking six or more drinks per week was associated with lower birth weight and higher risk of term SGA, but no increased risk of preterm birth. The analyses restricted to women without reproductive experience revealed similar results. Before 2000 approximately half of pregnant women drank alcohol. This decreased to 39% in 2000-2004, and 14% in 2005-2011. Before 2000, every additional drink was associated with reduced mean birth weight, whereas in 2005-2011, the mean birth weight increased with increasing intake. The period-specific associations between low-to-moderate drinking and birth weight, which also were observed for term SGA, are indicative of bias. It is impossible to distinguish if the bias is attributable to unmeasured confounding, which change over time or cohort heterogeneity.

Accuracy of the hypospadias diagnoses and surgical treatment registrations in the Danish National Patient Register.

PURPOSE: The Danish National Health registers provide a valuable data source that offers unique opportunities for observational research, including studies on the congenital anomaly hypospadias. The accuracy of the diagnosis and surgical treatment registration of hypospadias in the Danish National Patient Register (DNPR) remains unknown. PATIENTS AND METHODS: We randomly sampled 500 patients diagnosed with hypospadias in the DNPR from January 1, 1995 to December 31, 2012. Among these, 384 patients were also registered with surgical treatment for hypospadias. Medical records were collected and reviewed independently by two investigators. Any classification disagreements were resolved by consensus. Using the medical records as the gold standard, we estimated positive predictive values (PPVs) with 95% confidence intervals (CIs) for the hypospadias diagnoses and surgical treatment registrations overall, as well as for the clinical subtypes. RESULTS: We were able to retrieve medical records for 463 (92.6%) patients with hypospadias diagnoses and for 329 (85.7%) patients registered with surgical treatment. Presence of hypospadias was confirmed in 450 of 463 patients, yielding an overall PPV (95% CI) of 97.6% (95.8%-98.7%). For subtypes of hypospadias, the PPVs ranged between 37.5% and 72.7%. For surgical treatment of hypospadias, the overall PPV was 99.7% (97.9%-99.9%). CONCLUSION: The validity of the registration of hypospadias diagnoses as well as surgical treatment for hypospadias in the DNPR is overall very high. For the specific subtypes of hypospadias diagnoses codes and the specific surgical treatment codes, the PPVs are lower and cautious use is warranted. However, the DNPR remains a valuable tool for future observational research on hypospadias.

Maternal endometriosis and genital malformations in boys: a Danish register-based study.

OBJECTIVE: To investigate the association between maternal endometriosis and occurrence of the genital anomalies cryptorchidism and hypospadias in sons. DESIGN: Population-based cohort study. SETTING: Not applicable. PATIENT(S): All live-born singleton boys born from 1978 to 2012. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Cryptorchidism and hypospadias in boys based on information from the Danish National Patient Register. RESULT(S): The study included 1,073,026 live-born singleton boys. A total of 6,443 boys were sons of women diagnosed with endometriosis before pregnancy. Altogether, 27,342 boys were diagnosed with cryptorchidism, of whom 16,446 had corrective surgery. Hypospadias was diagnosed in 4,853 boys. As compared with unexposed boys, a tendency towards a slightly higher occurrence of cryptorchidism was observed among boys of women with endometriosis (adjusted hazard ratio [aHR] 1.18; 95% confidence interval [CI], 0.97, 1.44). When stratified by medically assisted reproduction (MAR) technologies, the association was slightly stronger among boys born to women with endometriosis who had conceived via MAR, yet it remained moderate and statistically insignificant (aHR 1.27; 95% CI, 0.86; 1.88). When women who conceived with MAR were excluded, the association between endometriosis and cryptorchidism disappeared. For hypospadias, we observed no association, either in the main analysis or the stratified analysis. CONCLUSION(S): The findings from this register-based study do not provide strong evidence for a higher occurrence of the studied genital anomalies among boys of women with endometriosis.

Maternal Overweight and Obesity and Genital Anomalies in Male Offspring: A Population-Based Swedish Cohort Study.

BACKGROUND: Overweight and obese pregnant women face higher risk of several critical birth outcomes, including an overall increased risk of congenital abnormalities. Only few studies have focused on associations between maternal overweight and the genital anomalies in boys, cryptorchidism and hypospadias, and results are inconclusive. METHODS: We performed a population-based cohort study and assessed the associations between maternal body mass index (BMI) in early pregnancy and occurrence of cryptorchidism and hypospadias. All live-born singleton boys born in Sweden from 1992 to 2012 were included. From the Swedish Patient Register, information on cryptorchidism and hypospadias was available. Data were analysed using Cox proportional hazards regression adjusted for potential confounders. Mediation analyses were performed to estimate how much of the association between BMI and genital anomalies were mediated through obesity-related diseases. RESULTS: Of the 1 055 705 live-born singleton boys born from 1992 to 2012, 6807 (6.4 per 1000) were diagnosed with hypospadias and 16 469 (15.6 per 1000) were diagnosed with cryptorchidism, of which 9768 (9.3 per 1000) underwent corrective surgery for cryptorchidism. We observed dose-response associations between maternal BMI and hypospadias and cryptorchidism. Boys of mothers with BMI ≥40.0 kg/m2 had the highest adjusted hazard ratios for hypospadias (HR 1.35, 95% confidence interval [CI] 1.04, 1.76) and cryptorchidism (HR 1.25, 95% CI 1.00, 1.58). A substantial proportion of the associations between BMI and the genital anomalies were mediated through preeclampsia. CONCLUSION: This large register-based study adds to the current literature and indicates that the occurrence of hypospadias and cryptorchidism increase with maternal overweight and obesity severity.

Placental Weight and Male Genital Anomalies: A Nationwide Danish Cohort Study.

The most consistently reported risk indicators for the male genital anomalies cryptorchidism and hypospadias are prematurity and low birth weight. Placental dysfunction has been hypothesized as a possible underlying cause, and an association between placental weight at birth and hypospadias has been indicated. In a population-based cohort of 388,422 Danish singleton boys born alive (1997-2008), we studied the association between placental weight and cryptorchidism and hypospadias. Missing data were handled with multiple imputation, and we estimated hazard ratios by means of Cox regression models. During follow-up, 1,713 boys were diagnosed with hypospadias and 6,878 with cryptorchidism (3,624 underwent corrective surgery). We observed an association between low placental weight and risk of both genital anomalies. Boys with a placental weight in the lowest decile (<10%) had higher risks of both cryptorchidism (hazard ratio = 1.52, 95% confidence interval: 1.31, 1.76) and hypospadias (hazard ratio = 1.97, 95% confidence interval: 1.59, 2.45) than boys in the reference decile (50.0-59.9%). In conclusion, we found higher risks of both genital malformations in boys born with a low placental weight. The relationship seemed stronger for hypospadias than for cryptorchidism. Taken together, our data support a role for placental dysfunction in the etiology of these anomalies.

Developmental Coordination Disorder in Children with a History of Infantile Colic.

OBJECTIVE: To investigate whether children with a history of infantile colic showed impaired motor development at age 7 years compared with unaffected peers. STUDY DESIGN: We studied 27,940 children from the Danish National Birth Cohort (1997-2002), including 1879 (6.8%) with a history of infantile colic. Infantile colic was defined according to the modified Wessel criteria as crying for more than 3 hours per day and more than 3 days per week. We compared the parental Developmental Coordination Disorder Questionnaire 2007 (DCDQ'07) scores in children with and without infantile colic after adjustment for intrauterine exposures, feeding type, parity, maternal age, socioeconomic status, Apgar score, gestational age, and birth weight. RESULTS: Children with a history of infantile colic had an elevated risk of scoring above the predefined cutoff limit of possible or suspected developmental coordination disorder (OR, 1.3; 95% CI, 1.0-1.7; P = .034). The mean total DCDQ'07 score was -0.4 point (95% CI, -0.8 to 0) lower in children with a history of infantile colic. Moreover, they were at higher risk for a low total score (OR for a 10-point decrease, 1.1; 95% CI, 1.0-1.1; P = .006) and a low general coordination score (OR, 1.3; 95% CI, 1.1-1.5, P = .000) in the DCDQ'07. All associations appeared to be stronger among boys, but no statistically significant effect measure modification between infantile colic and sex was found. CONCLUSION: We found no evidence of a strong association between infantile colic and developmental coordination disorder in this large Danish cohort.