Iatrogenic withdrawal syndrome frequently occurs in paediatric intensive care without algorithm for tapering of analgosedation.

BACKGROUND: Analgesics and sedatives are key elements to reduce physiological and psychological stress associated with treatment in paediatric intensive care. Prolonged drug use may induce tolerance and development of iatrogenic withdrawal syndrome (IWS) during the tapering phase. Our primary aim was to describe the prevalence of IWS among critically ill ventilated patients in two Norwegian paediatric intensive care units (PICUs), and secondary to investigate what motivated bedside nurses to administer additional drug doses. METHODS: Mechanically ventilated patients (n = 40) from newborn to eighteen years of age, with continuous infusions of opioids and benzodiazepines for 5 days or more, were included consecutively from May 2016 to June 2018. By using Withdrawal Assessment Tool-1 (WAT-1) twice daily we recorded the prevalence of IWS. Additionally, we recorded signs and symptoms that led bedside nurses to administration extra bolus medication. RESULTS: Peak WAT-1 score indicated an IWS prevalence of 95% in this selected group. The first days of the tapering phase were most critical for IWS. The most frequent symptoms triggering administration of additional bolus doses were agitation/restlessness, and thiopental and propofol were the bolus drugs used most frequently. CONCLUSIONS: IWS affected 95% of the children having received infusions of opioids and benzodiazepines for 5 days or more in PICUs without a tapering protocol for these drugs. This calls for implementation and testing of such weaning protocols.

The association of urine markers of iodine intake with development and growth among children in rural Uganda: a secondary analysis of a randomised education trial.

OBJECTIVE: We examined associations of urine iodide excretion, proxy for iodine intake, with child development and growth. DESIGN: This is a secondary analysis of a 1:1 cluster-randomised trial with a 6-month nutrition/stimulation/hygiene education intervention among mothers of children aged 6-8 months to improve child development and growth. Development was assessed using Bayley Scales of Infant and Toddler Development-III (BSID-III) and Ages and Stages Questionnaire (ASQ), whereas anthropometry was used to assess growth. Urine iodide concentration (UIC) and urine iodide/creatinine ratio (ICR) were measured. SETTING: The current study was conducted in southern Uganda. PARTICIPANTS: We randomly selected 155 children from the 511 enrolled into the original trial and analysed data when they were aged 20-24 and 36 months. RESULTS: Median UIC for both study groups at 20-24 and 36 months were similar (P > 0·05) and within the normal range of 100-199 µg/l (0·79-1·60 µmol/l), whereas the intervention group had significantly higher ICR at 20-24 months. The BSID-III cognitive score was positively associated (P = 0·028) with ICR at 20-24 months in the intervention group. The ASQ gross motor score was negatively associated (P = 0·020) with ICR at 20-24 months among the controls. ICR was not significantly associated with anthropometry in the two study groups at either time-point. CONCLUSIONS: Following the intervention, a positive association was noted between ICR and child's cognitive score at 20-24 months, whereas no positive association with ICR and growth was detected. Iodine sufficiency may be important for child's cognitive development in this setting.

Long term effectiveness of dialectical behavior therapy versus enhanced usual care for adolescents with self-harming and suicidal behavior.

BACKGROUND: Knowledge is lacking on the long-term outcomes of treatment for adolescents with repetitive suicidal and self-harming behavior. Furthermore, the pathways through which treatment effects may operate are poorly understood. Our aims were to investigate enduring treatment effects of dialectical behavior therapy adapted for adolescents (DBT-A) compared to enhanced usual care (EUC) through a prospective 3-year follow-up and to analyze possible mediators of treatment effects. METHODS: Interview and self-report data covering the follow-up interval were collected from 92% of the adolescents who participated in the original randomized trial. TRIAL REGISTRATION NUMBER: NCT01593202 (www.ClinicalTrials.gov). RESULTS: At the 3-year follow-up DBT-A remained superior to EUC in reducing the frequency of self-harm, whereas for suicidal ideation, hopelessness and depressive and borderline symptoms and global level of functioning there were no inter-group differences, with no sign of symptom relapse in either of the participant groups. A substantial proportion (70.8%) of the effect of DBT-A on self-harm frequency over the long-term was mediated through a reduction in participants' experience of hopelessness during the trial treatment phase. Receiving more than 3 months follow-up treatment after completion of the trial treatment was associated with further enhanced outcomes in patients who had received DBT-A. CONCLUSIONS: There were on average no between-group differences at the 3-year follow-up in clinical outcomes such as suicidal ideation, hopelessness, depressive and borderline symptoms. The significantly and consistently larger long-term reduction in self-harm behavior for adolescents having received DBT-A compared with enhanced usual care, however, suggests that DBT-A may be a favorable treatment alternative for adolescents with repetitive self-harming behavior.

Nutrition, hygiene, and stimulation education to improve growth, cognitive, language, and motor development among infants in Uganda: A cluster-randomized trial.

Stunting is associated with impaired cognitive and motor function. The effect of an education intervention including nutrition, stimulation, sanitation, and hygiene on child growth and cognitive/language/motor development, delivered to impoverished mothers in Uganda, was assessed. In a community-based, open cluster-randomized trial, 511 mother/children dyads aged 6-8 months were enrolled to an intervention (n = 263) or control (n = 248) group. The primary outcome was change in length-for-age z-score at age 20-24 months. Secondary outcomes included anthropometry and scores on the 2 developmental scales: Bayley Scales of Infant and Toddler Development-III and the Ages and Stages Questionnaire. There was no evidence of a difference in mean length-for-age z-score at 20-24 months between the 2 study groups: 0.10, 95% CI [-0.17, 0.36], p = .49. The intervention group had higher mean composite development scores than the controls on Bayley Scales of Infant and Toddler Development-III, the mean difference being 15.6, 95% CI [10.9, 20.2], p = .0001; 9.9, 95% CI [6.4, 13.2], p = .0001; and 14.6, 95% CI [10.9, 18.2], p = .0001, for cognitive, language, and motor composite scores, respectively. The mean difference in scores from the Ages and Stages Questionnaire were 7.0, 95% CI [2.9, 11.3], p = .001; 5.9, 95% CI [1.2, 10.3], p = .01; 4.2, 95% CI [1.7, 6.7], p = .001; 8.9, 95% CI [5.3, 12.3], p = .0001; and 4.4, 95% CI [0.0, 8.8], p = .05, for communication, gross motor, fine motor, problem solving, and personal-social development, respectively. The intervention education delivered to mothers promoted early development domains in cognitive, language, and motor development but not linear growth of small children in impoverished rural communities in Uganda. Our study showed that child development may be improved with a relatively low cost intervention strategy. This trial was registered at ClinicalTrials.gov as NCT02098031.

Plasma levels of marine n-3 polyunsaturated fatty acids and renal allograft survival.

BACKGROUND: Marine n-3 polyunsaturated fatty acids (PUFAs) may exert beneficial effects on inflammation, fibrosis, endothelial function, lipid profile and blood pressure that may prevent graft loss. METHODS: In this observational cohort study in Norwegian renal transplant recipients (n = 1990), transplanted between 1999 and 2011, associations between plasma marine n-3 PUFA levels and graft loss were assessed by multivariable Cox proportional hazard regression analysis. Plasma phospholipid fatty acid composition was determined by gas chromatography and individual fatty acids recorded as weight percentage (wt%) of total fatty acids in a stable phase 10 weeks after transplantation. RESULTS: During a median follow-up time of 6.8 years, 569 (28.6%) renal allografts were lost, either due to patient death (n = 340, 59.8% of graft loss) or graft loss in surviving patients (n = 229, 40.2%). Plasma marine n-3 PUFA levels ranged from 1.35 to 23.87 wt%, with a median level of 7.95 wt% (interquartile range 6.20-10.03 wt%). When adjusting for established graft loss risk factors, there was a 11% reduced risk of graft loss for every 1.0 wt% increase in marine n-3 PUFA level [adjusted hazard ratio (HR) 0.89; 95% confidence interval (CI) 0.84-0.93], and a 10% reduced risk of graft loss in surviving patients (adjusted HR 0.90; 95% CI 0.84-0.97). CONCLUSION: High levels of plasma marine n-3 PUFAs were associated with better renal allograft survival.

Prediction of clinically significant recurrence after partial nephrectomy. Data from the Cancer Registry of Norway with more than five years of follow-up.

OBJECTIVE: To determine recurrence incidence after partial nephrectomy (PN) for renal cell carcinoma and identify predictors for local recurrence (LR) and metastasis. MATERIAL AND METHODS: We retrospectively evaluated a cohort of 524 patients from the Cancer Registry of Norway, who underwent PN between January 2014 and December 2015 and were followed-up for >6 years. Patient demographics and pathological characteristics were correlated with recurrence and progression-free survival using Kaplan-Meier and Cox regression analyses. RESULTS: Median patient age was 64 years, and the median tumour size was 2.6 cm. A positive surgical margin (PSM) was observed in 11% of the cases, while the LR and metastasis rates were 3.4% and 3.2%, respectively. PSM (hazard ratio [HR], 55.4; 95% confidence interval [CI], 12.55-244.6), tumour number (HR, 45.4; 95% CI, 6.5-316.1) and stage (HR, 33.5; 95% CI, 5.4-205.3) were independent predictors for LR. Undetermined margin status was also a risk factor for LR. Tumour stage (HR, 41.05; 95% CI, 8.52-197.76), tumour necrosis (HR, 1.3; 95% CI, 0.4-4.31) and age (HR, 1.07; 95% CI, 1.01-1.14) were predictors for metastasis. CONCLUSIONS: Both local and distant recurrences after PN were rare, and the pT stage was a common predictor. PSM or indeterminate surgical margin and tumour number were LR predictors, while age at surgery and the presence of tumour necrosis predicted metastasis.

Prevalence of psychological distress in nurses, physicians and leaders working in intensive care units during the COVID-19 pandemic: a national one-year follow-up study.

OBJECTIVE: To report and compare psychological distress as symptoms of anxiety, depression and post-traumatic stress among intensive care units' (ICU) nurses, physicians and leaders at 12 months after the baseline survey (spring 2020), during the COVID-19 pandemic in Norway. Furthermore, to analyse which baseline demographic and COVID ICU-related factors have a significant impact on psychological distress at 12 months. DESIGN: Prospective, longitudinal, observational cohort study. SETTING: Nationwide, 27 of 28 hospitals with COVID ICUs in Norway. PARTICIPANTS: Nurses, physicians and their leaders. At 12 month follow-up 287 (59.3%) of 484 baseline participants responded. PRIMARY AND SECONDARY OUTCOME MEASURES: Symptoms of anxiety and depression using the Hopkins Symptoms Checklist-10 (HSCL-10). Symptoms of post-traumatic stress using the post-traumatic stress disease checklist for the Diagnostic and Statistical Manual of Mental Disorders 5 (PCL-5).Demographics (included previous symptoms of anxiety and depression) and COVID ICU-related factors (professional preparations, emotional experience and support) impacting distress at 12 months. RESULTS: Psychological distress, defined as caseness on either or both HSCL-10 and PCL-5, did not change significantly and was present for 13.6% of the participants at baseline and 13.2% at 12 month follow-up. Nurses reported significantly higher levels of psychological distress than physicians and leaders. Adjusted for demographics and the COVID ICU-related factors at baseline, previous symptoms of depression and fear of infection were significantly associated with higher levels of anxiety and depression at 12 months. Previous symptoms of depression, fear of infection and feeling of loneliness was significantly associated with more symptoms of post-traumatic stress. CONCLUSION: One year into the COVID-19 pandemic 13.2% of the ICUs professionals reported psychological distress, more frequently among the nurses. Fear of infection, loneliness and previous symptoms of depression reported at baseline were associated with higher levels of distress. Protective equipment and peer support are recommended to mitigate distress. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov. Identifier: NCT04372056.

The effects of short-term genistein intervention on prostate biomarker expression in patients with localised prostate cancer before radical prostatectomy.

Nutritionally relevant levels of genistein, the predominant isoflavone in soyabean associated with lower risk of prostate cancer (PCa), may modulate the expression of prostate tissue biomarkers associated with cancer prediction and progression. A phase 2 placebo-controlled, randomised, double-blind clinical trial was conducted in forty-seven Norwegian patients before prostatectomy. Intervention was 30 mg genistein or placebo capsules daily for 3-6 weeks. Luminal cells from malignant and benign glands were isolated with laser capture microdissection and the mRNA levels of androgen-related biomarkers (androgen receptor, NK3 homeobox 1, kallikrein-related peptide 4 (KLK4)) and cell cycle-related genes (p21 Waf1/Cip1 , p27 Kip1 , p53) were analysed with real-time semiquantitative PCR. Immunohistochemistry of androgen-, cell cycle-, proliferative- (Ki67 nuclear antigen), apoptotic- (B-cell CLL/lymphoma 2 (BCL-2) and BCL-2-associated X protein) and neuroendocrine differentiation-related biomarkers (neuron-specific enolase and cytoplasmic chromogranin A) was performed using tissue microarrays containing normal, Gleason grade 3 and grade 4 prostate tissues. There were no significant effects by genistein intervention on proliferation-, cell cycle-, apoptosis- or neuroendocrine biomarkers. Genistein intervention, however, significantly reduced the mRNA level of KLK4 in tumour cells (P = 0·033) and there was a non-significant reduction in androgen and cell cycle-related biomarkers, except for p27Kip1, whose expression in the nuclear compartment was increased. Genistein intervention modulated the expression of several biomarkers which may be related to PCa prediction and progression. The present study supports genistein as a chemopreventive agent in PCa. Further investigation is warranted in larger and longer-duration studies.

Cardiovascular abnormalities in adults with osteogenesis imperfecta.

BACKGROUND: The aim of this study was to investigate cardiac abnormalities in adults with osteogenesis imperfecta (OI). METHODS: The clinical and echocardiographic survey included 99 adults with OI divided into 3 clinical types-I, III, and IV-and 52 controls. Left ventricular end-diastolic dimensions (LVIDds), mass, and 4 aortic diameters were measured by standard echocardiography and indexed for body surface area. RESULTS: Hypertension was registered in 37 individuals (37.4%). The OI group had significantly lower body surface area than the control individuals, 1.7 ± 0.3 versus 1.9 ± 0.2 m(2) (P < .05). The LVIDd and LV mass were significantly larger in the OI group when compared with the controls, 2.98 ± .64 versus 2.59 ± .26 cm/m(2) (P < .05) and 97.3 ± 30.1 versus 73.3 ± 18.0 g/m(2) (P < .05), respectively. Type III OI showed significantly enlarged LVIDd as compared with types I and IV OI, 4.33 ± 1.10 versus 2.83 ± .33 (P < .05) versus 2.85 ± .37 cm/m(2) (P < .05), respectively. All aortic diameters were significantly larger in the OI group than in the control group, as they were in type III compared with types I and IV; 10.1% mild aortic regurgitation (AR), 10.1% moderate AR, and 7.1% moderate mitral regurgitation were registered in the OI group. CONCLUSIONS: Increased LVIDd, LV mass, mitral regurgitation, and AR were found in adult patients with OI compared with the control group. The changes in LV and dilatation of aorta seemed to be more pronounced in patients with type III compared with types I and IV OI.

Cardiovascular disease by diabetes status in five ethnic minority groups compared to ethnic Norwegians.

BACKGROUND: The population in Norway has become multi-ethnic due to migration from Asia and Africa over the recent decades. The aim of the present study was to explore differences in the self-reported prevalence of cardiovascular disease (CVD) and associated risk factors by diabetes status in five ethnic minority groups compared to ethnic Norwegians. METHODS: Pooled data from three population-based cross-sectional studies conducted in Oslo between 2000 and 2002 was used. Of 54,473 invited individuals 24,749 (45.4%) participated. The participants self-reported health status, underwent a clinical examination and blood samples were drawn. A total of 17,854 individuals aged 30 to 61 years born in Norway, Sri-Lanka, Pakistan, Iran, Vietnam or Turkey were included in the study. Chi-square tests, one-way ANOVAs, ANCOVAs, multiple and logistic regression were used. RESULTS: Age- and gender-standardized prevalence of self-reported CVD varied between 5.8% and 8.2% for the ethnic minority groups, compared to 2.9% among ethnic Norwegians (p < 0.001). Prevalence of self-reported diabetes varied from 3.0% to 15.0% for the ethnic minority groups versus 1.8% for ethnic Norwegians (p < 0.001). Among individuals without diabetes, the CVD prevalence was 6.0% versus 2.6% for ethnic minorities and Norwegians, respectively (p < 0.001). Corresponding CVD prevalence rates among individuals with diabetes were 15.3% vs. 12.6% (p = 0.364). For individuals without diabetes, the odds ratio (OR) for CVD in the ethnic minority groups remained significantly higher (range 1.5-2.6) than ethnic Norwegians (p < 0.05), after adjustment for age, gender, education, employment, and body height, except for Turkish individuals. Regardless of diabetes status, obesity and physical inactivity were prevalent in the majority of ethnic minority groups, whereas systolic- and diastolic- blood pressures were higher in Norwegians. In nearly all ethnic groups, individuals with diabetes had higher triglycerides, waist-to-hip ratio (WHR), and body mass index compared to individuals without diabetes. Age, diabetes, hypertension, hypercholesterolemia, and WHR were significant predictors of CVD in both ethnic Norwegians and ethnic minorities, but significant ethnic differences were found for age, diabetes, and hypercholesterolemia. CONCLUSIONS: Ethnic differences in the prevalence of CVD were prominent for individuals without diabetes. Primary CVD prevention including identification of undiagnosed diabetes should be prioritized for ethnic minorities without known diabetes.

Satisfaction with maternity care among recent migrants: an interview questionnaire-based study.

OBJECTIVE: To examine factors associated with recently migrated women's satisfaction with maternity care in urban Oslo, Norway. DESIGN: An interview-based cross-sectional study, using a modified version of Migrant Friendly Maternity Care Questionnaire. SETTING: Face-to-face interview after birth in two maternity wards in urban Oslo, Norway, from January 2019 to February 2020. PARTICIPANTS: International migrant women, ≤5 years length of residency in Norway, giving birth in urban Oslo, excluding women born in high-income countries. PRIMARY OUTCOME: Dissatisfaction of care during pregnancy and birth, measured using a Likert scale, grouped into satisfied and dissatisfied, in relation to socio-demographic/clinical characteristics and healthcare experiences. SECONDARY OUTCOME: Negative healthcare experiences and their association with reason for migration. RESULTS: A total of 401 women answered the questionnaire (87.6% response rate). Overall satisfaction with maternal healthcare was high. However, having a Norwegian partner, higher education and high Norwegian language comprehension were associated with greater odds of being dissatisfied with care. One-third of all women did not understand the information provided by the healthcare personnel during maternity care. More women with refugee background felt treated differently because of factors such as religion, language and skin colour, than women who migrated due to family reunification. CONCLUSIONS: Although the overall satisfaction was high, for certain healthcare experiences such as understanding information, we found more negative responses. The negative healthcare experiences and factors associated with satisfaction identified in this study have implications for health system planning, education of healthcare personnel and strategies for quality improvement.

Pro-inflammatory interleukins in patients operated on for proximal femur fracture.

OBJECTIVES: The aims of this study were to measure plasma IL 6 and IL 8 in patients with proximal femoral fracture (PFF) during the early phases of trauma and operation and to find out if there was any correlation between these ILs and the post-operative lower limb oedema. MATERIAL AND METHODS: Thirty patients with a median age of 81 years were grouped into pertrochanteric fracture (PTF) (n = 16) and femoral cervical fracture (FCF) (n = 14). Plasma interleukin levels were determined on blood samples obtained from the common femoral vein, immediately after hospital admission, 1 h before operation, and post-operatively at 1, 6, 12, 24, 48 h and on the 7th day. Thigh oedema was calculated by the frustum method. RESULTS: In the patients with PTF, maximum mean plasma IL-6 and IL-8 values were found, respectively at 24 h (45.12 pg/mL) and 6 hours (21.7 pg/mL) postoperatively. Whereas, in the patients with FCF, it was respectively, at 12 h (33.1 pg/mL) and 6 h (17.0 pg/mL), for IL-6 and IL-8 post operatively. The patients with PTF and FCF had respectively, 34.1% and 27.4% more thigh oedema in the operated limb on the 7th post-operative day as compared to the preoperative oedema volume (p<0.001). No significant correlation could be found between the plasma IL-6 and IL-8 levels and oedema in the operated limb. CONCLUSION: Increased levels of IL 6 and IL 8 suggest ongoing inflammation.

Quality of care for patients with type 2 diabetes in general practice according to patients' ethnic background: a cross-sectional study from Oslo, Norway.

BACKGROUND: In recent decades immigration to Norway from Asia, Africa and Eastern Europe has increased rapidly. The aim of this study was to assess the quality of care for type 2 diabetes mellitus (T2DM) patients from these ethnic minority groups compared with the care received by Norwegians. METHODS: In 2006, electronic medical record data were screened at 11 practices (49 GPs; 58857 patients). 1653 T2DM patients cared for in general practice were identified. Ethnicity was defined as self-reported country of birth. Chi-squared tests, one-way ANOVAs, multiple regression, linear mixed effect models and generalized linear mixed models were used. RESULTS: Diabetes was diagnosed at a younger age in patients from the ethnic minority groups (South Asians (SA): mean age 44.9 years, Middle East/North Africa (MENA): 47.2 years, East Asians (EA): 52.0 years, others: 49.0 years) compared with Norwegians (59.7 years, p < 0.001). HbA1c, systolic blood pressure (SBP) and s-cholesterol were measured in >85% of patients in all groups with minor differences between minority groups and Norwegians. A greater proportion of the minority groups were prescribed hypoglycaemic medications compared with Norwegians (>or=79% vs. 72%, p < 0.001). After adjusting for age, gender, diabetes duration, practice and physician unit, HbA1c (geometric mean) for Norwegians was 6.9% compared to 7.3-7.5% in the minority groups (p < 0.05). The proportion with poor glycaemic control (HbA1c > 9%) was higher in minority groups (SA: 19.6%, MENA: 18.9% vs. Norwegians: 5.6%, p < 0.001. No significant ethnic differences were found in the proportions reaching the combined target: HbA1c

Allergic sensitisation in tuberculosis patients at the time of diagnosis and following chemotherapy.

BACKGROUND: It is still a matter of debate whether there is an association between infection with Mycobacterium tuberculosis (M. tuberculosis) and allergy. Previously, we have shown higher levels of specific IgE to different inhalant allergens and total IgE in tuberculosis (TB) patients compared to controls. The objectives of this study were to evaluate a possible change in allergic sensitisation after successful TB treatment and to confirm the finding of our previous study of enhanced allergic sensitisation in TB patients compared to controls in a more controlled setting. Additionally, we wanted to determine the cytokine profile in the same groups and finally to evaluate the association between the presence of Bacillus Calmette-Guérin vaccination (BCG) scar and allergic sensitisation among the controls. METHODS: Sera were analysed for specific IgE to inhalant allergens (Phadiatop) and total IgE by the use of ImmunoCAP 1000 (Pharmacia Diagnostics). Thirteen different cytokines were also analysed in the sera by multiplex bead immunoassay (Luminex 100, Luminex Corporation), and clinical symptoms of allergy and BCG scar were reported in a questionnaire. RESULTS: A reduction in levels of specific and total IgE were observed after successful TB treatment. TB patients also had higher levels of specific and total IgE compared to healthy controls. Both interleukin (IL)-6 and interferon (IFN)gamma were higher in TB patients compared to healthy controls. The levels of IL-6 were reduced after successful TB treatment. The presence of a BCG scar was associated with a reduced risk of developing allergic sensitisation. CONCLUSION: We observed a reduced level of allergic sensitisation after successful TB treatment. TB patients seem to be more allergically sensitised than healthy controls, confirming our previous finding. Furthermore, we observed an inverse association between allergic sensitisation and visible BCG scar, which adds additional support to the hygiene hypothesis.

Women's satisfaction with midwife-led continuity of care: an observational study in Palestine.

OBJECTIVES: A midwife-led continuity model of care had been implemented in the Palestinian governmental health system to improve maternal services in several rural areas. This study investigated if the model influenced women's satisfaction with care, during antenatal, intrapartum and postnatal period. DESIGN: An observational case-control design was used to compare the midwife-led continuity model of care with regular maternity care. PARTICIPANTS AND SETTING: Women with singleton pregnancies, who had registered for antenatal care at a rural governmental clinic in the West Bank, were between 1 to 6 months after birth invited to answer a questionnaire rating satisfaction with care in 7-point Likert scales. PRIMARY OUTCOME: The mean sum-score of satisfaction with care through the continuum of antenatal, intrapartum and postnatal period, where mean sum-scores range from 1 (lowest) to 7 (highest). SECONDARY OUTCOME: Exclusive breastfeeding. RESULTS: Two hundred women answered the questionnaire, 100 who received the midwife-led model and 100 who received regular care. The median time point of interview were 16 weeks postpartum in both groups. The midwife-led model was associated with a statistically significant higher satisfaction with care during antenatal, intrapartum and postnatal period, with a mean sum-score of 5.2 versus 4.8 in the group receiving regular care. The adjusted mean difference between the groups' sum-score of satisfaction with care was 0.6 (95% CI 0.35 to 0.85), p<0.0001. A statistically significant higher proportion of women who received the midwife-led continuity model of care were still exclusively breastfeeding at the time point of interview, 67% versus 46% in the group receiving regular care, an adjusted OR of 2.56 (1.35 to 4.88) p=0.004. CONCLUSIONS: There is an association between receiving midwife-led continuity of care and increased satisfaction with care through the continuum of pregnancy, intrapartum and postpartum period, and an increased duration of exclusive breastfeeding. TRIAL REGISTRATION NUMBER: NCT03863600.

Importance of Syndesmotic Reduction on Clinical Outcome After Syndesmosis Injuries.

OBJECTIVES: To evaluate the relationship between syndesmosis reduction and outcome. DESIGN: Retrospective cohort study. SETTING: One Level 1 and 1 Level 3 Trauma Center. PATIENTS: Ninety-seven patients with syndesmosis injury. INTERVENTION: Stabilization of syndesmosis injury. Open reduction and internal fixation of malleolar fracture, if present. MAIN OUTCOME MEASUREMENTS: Anterior, central, and posterior measures of syndesmosis width on computed tomography scans, Olerud-Molander Ankle score, American Orthopaedic Foot and American Orthopaedic Foot and Ankle Society Ankle-Hindfoot score, and range of motion measurements. RESULTS: Eighty-seven patients completed 2 years of follow-up. The difference in anterior tibiofibular distance (aTFD) between the injured and noninjured ankle postoperatively had a significant effect on the Olerud-Molander Ankle score after 6 weeks [b = -2.6, 95% confidence interval (CI), -4.8 to -0.4; P = 0.02], 1 year (b = -2.7, 95% CI, -4.7 to -0.8; P < 0.001), and 2 years (b = -2.6, 95% CI, -4.6 to -0.6; P = 0.009) and on American Orthopaedic Foot and Ankle Society Ankle-Hindfoot score after 6 weeks (b = -2.2, 95% CI, -3.7 to -0.7; P = 0.004), 1 year (b = -1.7, 95% CI, -3.0 to -0.4; P = 0.04), and 2 years (b = -1.9, 95% CI, -3.2 to -0.5; P = 0.006). The effect of computed tomography measurements on range of motion was inconsistent. Receiver operating characteristic (ROC) curves demonstrated that aTFD had adequate discriminatory performance (area under the ROC curve ≥ 0.7) 1 and 2 years after surgery and the central measurement at only 2 years after surgery. ROC analyses indicate a cutoff value for syndesmosis malreduction of 2 mm. The postoperative rate of malreduction was 32%. CONCLUSIONS: The aTFD correlated with clinical outcome. A 2-mm difference in aTFD seems to predict poorer clinical outcome. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Child development, growth and microbiota: follow-up of a randomized education trial in Uganda.

BACKGROUND: Undernutrition impairs child development outcomes and growth. In this follow-up study of an open cluster-randomized intervention trial we examined the effects of an education package delivered to mothers in rural Uganda on their children's development, growth and gut microbiota at 36 months of age. METHODS: The parental trial included 511 mother-child pairs recruited when the children were 6-8 months. In that trial, a nutrition, stimulation and hygiene education was delivered to mothers in the intervention group while the control group received routine health care. A follow-up sample of 155 pairs (intervention n = 77, control n = 78) were re-enrolled when the children were 24 months. Developmental outcomes were assessed with the Bayley Scales of Infant and Toddler Development (BSID-III) composite scores for cognitive (primary endpoint), language and motor development. Development outcomes were also evaluated using the Ages and Stages Questionnaire (ASQ) and the Mullen Scales of Early Learning (MSEL). Other outcomes included growth and gut microbiota composition. RESULTS: The demographic characteristics were not different (P > 0.05) between the intervention and control groups and similar to those of the parental study. The intervention group had higher BSID-III scores than controls, with mean difference 10.13 (95% confidence interval (CI): 3.31-17.05, P = 0.002); 7.59 (1.62-13.66, P = 0.01); 9.00 (2.92-15.40, P = 0.005), for cognitive, language and motor composite scores, respectively. An improvement in the intervention compared to the control group was obtained for both the ASQ and the MSEL scores. The mean difference in height-for-age z-score was higher in the intervention compared to the control group: 0.50 (0.25-0.75, P = 0.0001). Gut microbiota composition did not differ significantly between the two study groups. CONCLUSIONS: The maternal education intervention had positive effects on child development and growth at three years, but did not alter gut microbiota composition. This intervention may be applicable in other low-resource settings. TRIAL REGISTRATION: ClinicalTrials.gov registration number NCT02098031.

Extracorporeal shockwave lithotripsy versus ureteroscopy for 5- to 10-mm stones in the proximal ureter: Prospective effectiveness patient-preference trial.

BACKGROUND: To establish the best treatment modality in our hospitals for patients with proximal-ureteral calculi 5 to 10 mm, we compared the treatment outcome in those who underwent primary ureteroscopy (URS) with that in patients who underwent primary in-situ SWL. The primary endpoints were stone-free rates at 3 weeks and 3 months and the subjective patient experience. PATIENTS AND METHODS: The study was a prospective patient-preference trial. From September 2002 to May 2005, 80 patients were included, of whom 71 could be evaluated. Thirty-three patients were treated with SWL and 38 with semirigid or flexible URS. Stone status was evaluated with excretory urography or noncontrast helical CT. The bother score of urinary-tract symptoms was recorded on a visual analog scale. RESULTS: The stone-free rate at 3 weeks was 58% and 78% (P = 0.061) and at 3 months 88% and 89% (P = 1) for SWL and URS, respectively. The percentage of patients in need of analgesics was 30% and 49% (P = 0.118) at 3 weeks and 9% and 21% (P = 0.181) at 3 months for the SWL and the URS group, respectively. The bother score regarding dysuria, hematuria, and flank pain were statistically significant in favor of SWL. CONCLUSION: Ureteroscopy tends to make patients stone free faster, but SWL is preferred by most patients because there is less discomfort after treatment.

The impact of borderline personality disorder and sub-threshold borderline personality disorder on the course of self-reported and clinician-rated depression in self-harming adolescents.

BACKGROUND: Studies on adults suggest that the presence of comorbid depression and Borderline Personality Disorder (BPD) is associated with an elevated risk of self-harming behaviours and that self-harming behaviours, when present, will have higher severity. This comorbidity, furthermore, complicates clinical assessments, which may be an obstacle to early identification and proper intervention. Adolescents who self-harm frequently report high levels of depressive symptoms, but this is often not reflected in the clinicians' assessment. BPD is still a controversial diagnosis in young people, and less is known about the clinical significance of comorbid BPD in adolescent populations.The purpose of the present study was to examine the impact of BPD on the assessment and course of self-reported and clinician-rated depression in self-harming adolescents before and after a treatment period of 19 weeks. We hypothesized that, compared to adolescents without BPD, adolescents with BPD would self-report higher levels of depression at baseline, and that they would have less reduction in depressive symptoms. METHODS: A total of 39 adolescents with depressive disorders and BPD-traits participating in a randomised controlled trial on treatment of self-harm with Dialectical Behaviour Therapy adapted for Adolescents or enhanced usual care were included. Adolescents with full-syndrome BPD (n = 10) were compared with adolescents with sub-threshold BPD (n = 29) with respect to their self-reported and clinician-rated depressive symptoms, suicidal ideation and global level of functioning at baseline, and after 19 weeks of treatment (end of trial period). RESULTS: At baseline, adolescents with full-syndrome BPD self-reported significantly higher levels of depressive symptoms and suicidal ideation compared to adolescents with sub-threshold BPD, whereas the two groups were rated as equally depressed by the clinicians. At trial completion, all participants had a significant reduction in suicidal ideation, however, adolescents with BPD had a poorer treatment outcome in terms of significantly higher levels of clinician-rated and self-reported depressive symptoms and significantly lower levels of global functioning. At baseline as well as at trial completion, self-reported and clinician-rated levels of depressive symptoms were not significantly correlated in adolescents with BPD. In a multiple linear regression analysis, a diagnosis of BPD and a high baseline level of clinician-rated depressive symptoms predicted higher levels of depressive symptoms at trial completion, whereas receiving Dialectical Behaviour Therapy predicted lower levels of depressive symptoms. CONCLUSION: Our findings suggest that a diagnosis of BPD may have a strong impact on the assessment and course of depressive symptoms in self-harming adolescents. Although rated as equally depressed, adolescents with BPD self-reported significantly higher levels of depressive symptoms and suicidal ideation at baseline, and showed a poorer outcome in terms of higher levels of depressive symptoms and lower levels of global functioning at trial completion compared to adolescents with sub-threshold BPD. Our findings suggest that receiving Dialectical Behaviour Therapy could lead to a greater reduction in depressive symptoms, although firm conclusions cannot be drawn given the limited sample size.Clinicians should be aware of the possibility of underestimating the severity of depression in the context of emotional and behavioral dysregulation. Providing BPD specific treatments seems to be important to achieve sufficient treatment response with regard to depressive symptoms in adolescents with BPD-traits. TRIAL REGISTRATION: Treatment for Adolescents With Deliberate Self Harm; NCT00675129, registered May 2008.

Dialectical Behavior Therapy Compared With Enhanced Usual Care for Adolescents With Repeated Suicidal and Self-Harming Behavior: Outcomes Over a One-Year Follow-Up.

OBJECTIVE: We conducted a 1-year prospective follow-up study of posttreatment clinical outcomes in adolescents with recent and repetitive self-harm who had been randomly allocated to receive 19 weeks of either dialectical behavior therapy adapted for adolescents (DBT-A) or enhanced usual care (EUC) at community child and adolescent psychiatric outpatient clinics. METHOD: Assessments of self-harm, suicidal ideation, depression, hopelessness, borderline symptoms, and global level of functioning were made at the end of the 19-week treatment period and at follow-up 1 year later. Altogether 75 of the 77 (97%) adolescents participated at both time points. Frequencies of hospitalizations, emergency department visits and other use of mental health care during the 1-year follow-up period were recorded. Change analyses were performed using mixed effects linear spline regression and mixed effect Poisson regression with robust variance. RESULTS: Over the 52-week follow-up period, DBT-A remained superior to EUC in reducing the frequency of self-harm. For other outcomes such as suicidal ideation, hopelessness, and depressive or borderline symptoms and for the global level of functioning, inter-group differences apparent at the 19-week assessment were no longer observed, mainly due to participants in the EUC group having significantly improved on these dimensions over the follow-up year, whereas DBT-A participants remained unchanged. CONCLUSION: A stronger long-term reduction in self-harm and a more rapid recovery in suicidal ideation, depression, and borderline symptoms suggest that DBT-A may be a favorable treatment alternative for adolescents with repetitive self-harming behavior. CLINICAL TRIAL REGISTRATION INFORMATION: Treatment for Adolescents With Deliberate Self Harm; http://clinicaltrials.gov/; NCT00675129.