Lone Nikoline Nørgaard

The Effects of Simulation-based Transvaginal Ultrasound Training on Quality and Efficiency of Care: A Multicenter Single-blind Randomized Trial

Objective: To explore the effect of adding simulation-based transvaginal ultrasound training to trainees’ clinical training compared with only clinical training on quality of and efficiency of care. Background: Simulation-based ultrasound training may be an effective adjunct to clinical training, but no studies have examined its effects on quality and efficiency of care. Methods: Trainees from 4 University Hospitals in East Denmark were included (N = 54). Participants were randomized to either simulation-based ultrasound training and clinical training (intervention group, n = 28), or to clinical training only (control group, n = 26). The primary outcome was patient-reported discomfort during transvaginal ultrasound examinations performed by study participants. Secondary outcomes included patient-reported perceived safety and confidence in ultrasound provider. Finally, the need for trainee supervision or repeated patient examinations was recorded. Results: In total, 1150 patient ratings were collected. The intervention was associated with a reduction of patient discomfort by 18.5% [95% confidence interval (CI), 10.7–25.5; P < 0.001), and with a 7.9% (95% CI, 0.5–14.7; P = 0.04) increase in perceived safety. The intervention group participants received 11.1% (95% CI, 2.5–18.9) higher scores on patients’ confidence compared with control group participants (P = 0.01). When the number of days of clinical training was doubled, the odds for trainee supervision or repeated patient examination was reduced by 45.3% (95% CI, 33.5–55.1) and 19.8% (95% CI, 4.1–32.9) in the intervention and control group, respectively (P = 0.005). Conclusions: Simulation-based ultrasound training improved quality of care and reduced the need for repeated patient examination and trainee supervision.

Fetal Growth in Pregnancies Conceived after Gastric Bypass Surgery in Relation to Surgery-to-Conception Interval: A Danish National Cohort Study

Objective To describe early and late fetal growth in pregnancies conceived after gastric bypass surgery in relation to time from surgery to conception of pregnancy. Methods National cohort study on 387 Danish women, who had laparoscopic or open gastric bypass surgery prior to a singleton pregnancy in which first trimester screening was performed between January 2008 and June 2011. Data were derived from national registers (Danish National Registry of Patients and Danish National Birth Registry, Pregnancy Complications and Abortion - clinical quality database (PreCAb) and the Danish Fetal Medicine Database). Main outcome measures were early and late fetal growth in relation to time from bariatric surgery to conception of the pregnancy. Early fetal growth was expressed as “Fetal Growth Index”: the ratio between the estimated number of days from first trimester ultrasound to second trimester ultrasound biometries and the actual calender time elapsed in days. Late fetal growth was expressed as the observed versus expected birthweight according to gestational age (GA). Results The surgery-to-conception interval ranged from 3 to 1851 days with a mean value of 502 (SD, 351) days. The mean “fetal growth index” was 0.99 (SD, 0.02) days/day and thus significantly lower than in the background population (mean, 1.04 (SD, 0.09) days/day, p<0.0001). The proportion of infants being small for gestational age was 18.8% and the proportion of large for gestational age infants was 6.7%. The correlation coefficients between surgery-to-conception time and “fetal growth index” and birthweight according to GA were 0.01 (p = 0.8) and 0.04 (p = 0.4), respectively. Conclusion Fetal growth index was lower than reported in the background population. No correlation was found between the surgery-to-conception interval and early or late fetal growth in pregnancies conceived after gastric bypass surgery.

At cancer diagnosis: a 'window of opportunity' for behavioural change towards physical activity. A randomised feasibility study in patients with colon and breast cancer.

Introduction Challenges exist in identifying, recruiting and motivating sedentary patients with cancer to initiate physical activity towards recommended levels. We hypothesise that the onset period of adjuvant chemotherapy can be ‘the open window of opportunity’ to identify and motivate sedentary patients with breast and colon cancers, at risk for developing coronary heart disease, to initiate and sustain lifestyle changes. Aims To investigate the feasibility of oncologists/nurses screening for physical inactivity, in order to identify and recruit an at-risk population of sedentary patients with breast or colon cancer at the onset of adjuvant chemotherapy. Furthermore, the study will examine the adherence to one of two multimodal exercise interventions lasting 12 weeks; (1) hospital-based, high intensity, group exercise intervention (2) home-based, low intensity, individual, pedometer intervention. Both arms will be compared with a control group. Methods and analyses All newly referred patients will be screened for sedentary behaviour, using national recommendations. Testing at baseline, 6, 12 and 39 weeks will include; (1) physiological testing (VO2-peak, one repetition maximum muscle strength and lung function (2) fasting full body dual-energy X-ray absorptiometry scan (3) fasting blood glucose, insulin, lipids and cholesterols, (4) psychometric questionnaires (general well-being, quality of life, anxiety and depression, motivational readiness). The randomised controlled trial feasibility design is selected in order to examine barriers for recruitment, programme adherence, safety aspects and potential efficacy to the interventions during adjuvant chemotherapy. Ethics and dissemination The Scientific Committee of the Capital Region (case No. H-1-2011-131) and the Danish Data Protection Agency (j. No. 2011-41-6349) approved the study. Data will be entered and locked into a database hosted by the Copenhagen Trial Unit, Rigshosptialet. Data will be available for analyses to project members and the trial statistician after the 45 included patients have completed the 12-week test. Results will be published in peer-reviewed scientific journals. Trial registration Current Controlled Trials ISRCTN24901641.

The challenge of preserving cardiorespiratory fitness in physically inactive patients with colon or breast cancer during adjuvant chemotherapy: a randomised feasibility study

Introduction Anti-neoplastic treatment is synonymous with an inactive daily life for a substantial number of patients. It remains unclear what is the optimal setting, dosage and combination of exercise and health promoting components that best facilitate patient adherence and symptom management in order to support cardio-respiratory fitness and lifestyle changes in an at-risk population of pre-illness physically inactive cancer patients. Methods Patients with breast or colon cancer referred to adjuvant chemotherapy and by the oncologists pre-screening verified as physically inactive were eligible to enter a randomised three-armed feasibility study comparing a 12-week supervised hospital-based moderate to high intensity exercise intervention or alternate an instructive home-based12-week pedometer intervention, with usual care. Results Using a recommendation based physical activity screening instrument in order to correspond with cardio-respiratory fitness (VO2 peak) proved to be an applicable method to identify pre-illness physically inactive breast and colon cancer patients. The study demonstrated convincing recruitment (67%), safety and intervention adherence among breast cancer patients; while the attendance rate for colon cancer patients was notably lower (33%). VO2-peak declined on average 12% across study groups from baseline to 12 weeks though indices towards sustaining watt performance and reduce fat mass favoured the hospital-based intervention. Pedometer use was well adapted in both breast and colon cancer patients. Conclusions Despite a fair adherence and safety, the current study calls into question whether aerobic exercise, regardless of intensity, is able to increase VO2-peak during texane-based chemotherapy in combination with Neulasta in physically inactive breast cancer patients. Trial Registration: ISRCTN24901641

Use of new Intrauterine Shunt for fetal fluid accumulations. Single Center experience from first 17 cases

Pleural effusion is the most common fluid-accumulation in the fetus with a prevalence of 1:15.000-24.000 pregnancies.1 The clinical picture is highly variable ranging from spontaneous resolution to lung hypoplasia, hydrops and death.1 Treatment options include thoracocentesis, thoraco-amniotic shunting and pleurodesis using OK-432.2 The conventional thoraco-amniotic shunts are applied using a 13-16G trochar.3,4 Somatex® Intrauterine Shunt (IUS) was launched in 2014 and consists of a self-expanding nitinol wire mesh with an inner silicone coating to be inserted through an 18G/1.2 mm needle.

Long-Term Neurodevelopmental Outcome of Monochorionic Twins after Laser Therapy or Umbilical Cord Occlusion for Twin-Twin Transfusion Syndrome

Introduction: We sought to assess the incidence of severe neurodevelopmental impairment (NDI) in monochorionic twins treated for twin-twin transfusion syndrome (TTTS) and compare it to the incidence in uncomplicated monochorionic twins. Material and Methods: We included TTTS pregnancies treated by fetoscopic selective laser coagulation (FSLC) or umbilical cord occlusion (UCO) in 2004–2015. Primary outcome was severe NDI defined as cerebral palsy, bilateral blindness or bilateral deafness (ICD-10 diagnoses), and severe cognitive and/or motor delay (assessed by the Ages and Stages Questionnaires [ASQ]). Results: A total of 124 children after TTTS and 98 controls were followed up at 25 months of age (SD 11.4). Severe NDI was found in 8.9% of the TTTS children (10.5% [9/86] after FSLC; 5.3% [2/38] after UCO) compared to 3.1% in the control group (p = 0.10). The odds ratio for severe NDI was 1.8 in cases versus controls (p = 0.37). The total ASQ score was significantly lower in the TTTS group than in controls (p = 0.03) after FSLC (p = 0.03) and after UCO (p = 0.14). Discussion: Children after TTTS appear to have a higher risk of severe NDI and score significantly lower on the ASQ compared to monochorionic twins from uncomplicated pregnancies.

OK-432 Treatment of Early Fetal Chylothorax: Pregnancy Outcome and Long-Term Follow-Up of 14 Cases

Background: The treatment options for fetal chylothorax include thoracocentesis, thoracoamniotic shunting, and pleurodesis using OK-432. Knowledge on the long-term outcomes after treatment with OK-432 is limited. Objective: The aim of this study was to assess the long-term outcomes of children treated in utero with OK-432. Methods: We performed follow-up on pregnancies and children treated in utero with OK-432 between 2003 and 2009 at Copenhagen University Hospital Rigshospitalet for pleural effusions at gestational age (GA) 16+0–21+6 weeks. Anamnestic information, physical examination, pulmonary function test, neuropediatric examination, and intelligence testing using the Wechsler Intelligence Scale were used for evaluation. Results: Fourteen cases, all chylothorax, were treated with OK-432. None had preterm premature rupture of membranes (PPROM), and the median GA at delivery was 38+5 (24+4–41+5) weeks. Twelve children were eligible for follow-up. The median age at follow-up was 11.4 (7.8–13.8) years. Pulmonary function was normal in all children and the mean full-scale IQ did not differ from that of normal children. Four children had a diagnosed medical condition, attention deficit disorder, or genetic syndrome. The remaining children had normal follow-up. Conclusion: Children treated with OK-432 have comparable survival rates and long-term neurodevelopmental outcomes to those treated with thoracoamniotic shunts. There seems to be a lower risk of procedure-related PPROM.