The frequency of intrapartum caesarean section use with the WHO partograph versus Zhang's guideline in the Labour Progression Study (LaPS): a multicentre, cluster-randomised controlled trial.

BACKGROUND: There is an ongoing debate concerning which guidelines and monitoring tools are most beneficial for assessing labour progression, to help prevent use of intrapartum caesarean section (ICS). The WHO partograph has been used for decades with the assumption of a linear labour progression; however, in 2010, Zhang introduced a new guideline suggesting a more dynamic labour progression. We aimed to investigate whether the frequency of ICS use differed when adhering to the WHO partograph versus Zhang's guideline for labour progression. METHODS: We did a multicentre, cluster-randomised controlled trial at obstetric units in Norway, and each site was required to deliver more than 500 fetuses per year to be eligible for inclusion. The participants were nulliparous women who had a singleton, full-term fetus with cephalic presentation, and who entered spontaneous active labour. The obstetric units were treated as clusters, and women treated within these clusters were all given the same treatment. We stratified these clusters by size and number of previous caesarean sections. The clusters containing the obstetric units were then randomly assigned (1:1) to the control group, which adhered to the WHO partograph, or to the intervention group, which adhered to Zhang's guideline. The randomisation was computer-generated and was done in the Unit of Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway, and investigators in this unit had no further involvement in the trial. Our study design did not enable masking of participants or health-care providers, but the investigators who were analysing the data were masked to group allocation. The primary outcome was use of ICS during active labour (cervical dilatation of 4-10 cm) in all participating women. The Labour Progression Study (LaPS) is registered with ClinicalTrials.gov, number NCT02221427. FINDINGS: Between Aug 1, 2014, and Sept 1, 2014, 14 clusters were enrolled in the LaPS trial, and on Sept 11, 2014, seven obstetric units were randomly assigned to the control group (adhering to the WHO partograph) and seven obstetric units were randomly assigned to the intervention group (adhering to Zhang's guideline). Between Dec 1, 2014, and Jan 31, 2017, 11 615 women were judged to be eligible for recruitment in the trial, which comprised 5421 (46·7%) women in the control group units and 6194 (53·3%) women in the intervention group units. In the control group, 2100 (38·7%) of 5421 women did not give signed consent to participate and 16 (0·3%) women abstained from participation. In the intervention group, 2181 (35·2%) of 6194 women did not give signed consent to participate and 41 (0·7%) women abstained from participation. 7277 (62·7%) of 11 615 eligible women were therefore included in the analysis of the primary endpoint. Of these women, 3305 (45·4%) participants were in an obstetric unit that was randomly assigned to the control group (adhering to the WHO partograph) and 3972 (54·6%) participants were in an obstetric unit that was randomly assigned to the intervention group (adhering to Zhang's guideline). No women dropped out during the trial. Before the start of the trial, ICS was used in 9·5% of deliveries in the control group obstetric units and in 9·3% of intervention group obstetric units. During our trial, there were 196 (5·9%) ICS deliveries in women in the control group (WHO partograph) and 271 (6·8%) ICS deliveries in women in the intervention group (Zhang's guideline), and the frequency of ICS use did not differ between the groups (adjusted relative risk 1·17, 95% CI 0·98-1·40; p=0·08; adjusted risk difference 1·00%, 95% CI -0·1 to 2·1). We identified no maternal or neonatal deaths during our study. INTERPRETATION: We did not find any significant difference in the frequency of ICS use between the obstetric units assigned to adhere to the WHO partograph and those assigned to adhere to Zhang's guideline. The overall decrease in ICS use that we observed relative to the previous frequency of ICS use noted in these obstetric units might be explained by the close focus on assessing labour progression more than use of the guidelines. Our results represent an important contribution to the discussion on implementation of the new guideline. FUNDING: Østfold Hospital Trust.

Can we trust the new generation of infrared tympanic thermometers in clinical practice?

AIMS AND OBJECTIVES: To explore the reliability and validity of the new generation of infrared tympanic thermometers, comparing with rectal and core temperature, and to decide their applicability to clinical practice. BACKGROUND: Digital contact thermometers for rectal measurements and infrared tympanic thermometers are the most common way to measure patients' temperature. Previous studies of the infrared tympanic thermometers revealed misdiagnosis, and validity of early models was questioned. DESIGN: Reliability and validity study. METHODS: Temperature was measured with two infrared tympanic thermometers brands in both ears and compared with rectal temperature twice a day at the ward (n = 200). At the intensive care unit, patients (n = 42) underwent the same measurement procedures every fourth hour for 24 hours. In addition, core temperature was measured. Statistical analyses included descriptive and mixed models analyses. RESULTS: Ward: Infrared tympanic thermometers measured the temperature lower than the rectal temperature. Descriptive statistics indicate higher variation in temperature measurements made in the ear. No statistically significant difference in temperature was found for left ear vs. right ear. Intensive care unit: The mean rectal temperature was higher than the mean core and ear temperature. Mixed models analyses of the temperatures at the ward and the intensive care unit showed the same overall trends, but with less discrepancy between the two infrared tympanic thermometers brands, compared with the rectal temperature. Only rectal temperature measurements differed significantly from the core temperature. CONCLUSION: Our study shows good reliability using the new generation of infrared tympanic thermometers. We found good agreement between core and infrared tympanic thermometers at the intensive care unit, but the measuring inaccuracy for infrared tympanic thermometers was greater than expected. RELEVANCE TO CLINICAL PRACTICE: The new generation of infrared tympanic thermometers may be used in clinical practice, but it is important to do repeatedly measurements if there is discrepancy between the temperature and the observation of the patient condition.

Categorisation of continuous exposure variables revisited. A response to the Hyperglycaemia and Adverse Pregnancy Outcome (HAPO) Study.

BACKGROUND: Although the general statistical advice is to keep continuous exposure variables as continuous in statistical analyses, categorisation is still a common approach in medical research. In a recent paper from the Hyperglycaemia and Adverse Pregnancy Outcome (HAPO) Study, categorisation of body mass index (BMI) was used when analysing the effect of BMI on adverse pregnancy outcomes. The lowest category, labelled "underweight", was used as the reference category. METHODS: The present paper gives a summary of reasons for categorisation and methodological drawbacks of this approach. We also discuss the choice of reference category and alternative analyses. We exemplify our arguments by a reanalysis of results from the HAPO paper. RESULTS: Categorisation of continuous exposure data results in loss of power and other methodological challenges. An unfortunate choice of reference category can give additional lack of precision and obscure the interpretation of risk estimates. A highlighted odds ratio (OR) in the HAPO study is the OR for birth weight >90(th) percentile for women in the highest compared to the lowest BMI category ("obese class III" versus "underweight"). This estimate was OR = 4.55 and OR = 3.52, with two different multiple logistic regression models. When using the "normal weight" category as the reference, our corresponding estimates were OR = 2.03 and OR = 1.62, respectively. Moreover, our choice of reference category also gave narrower confidence intervals. SUMMARY: Due to several methodological drawbacks, categorisation should be avoided. Modern statistical analyses should be used to analyse continuous exposure data, and to explore non-linear relations. If continuous data are categorised, special attention must be given to the choice of reference category.

Walking ability and predictors of performance on the 6-minute walk test in adults with spastic cerebral palsy.

AIM: To describe walking ability and identify factors predicting walking capacity in adults with spastic cerebral palsy (CP) assessed with the 6-minute walk test (6MWT). METHOD: A cross-sectional clinical study as part of the recruitment process for a randomized controlled trial on the effects of botulinum toxin A. Data analysed were the 6MWT, Timed Up and Go (TUG) test, Borg Scale, spasticity, muscle strength, popliteal angle, pain, fatigue, type of CP, foot deformity, Gross Motor Function Classification System (GMFCS) levels, Functional Mobility Scale (FMS) scores, a gait questionnaire, interview, and demographic data. RESULTS: In total, 126 persons were included (53 males, 73 females; mean age 39 y [SD 12 y]; 59 with unilateral and 67 with bilateral spastic CP; GMFCS level I, n=12; level II, n=94; level III, n=20). Mean distance on the 6MWT was 485 m (SD 95 m) with FMS scores reflecting independent walking performance in daily life. Multiple regression analysis identified sex, type of CP, popliteal angle, pain, and TUG values as significant predictors, with TUG values as the strongest predictor (standardized regression coefficient=-0.57, p<0.001). INTERPRETATION: Our results demonstrate that 39% of the participants had declined one GMFCS level from adolescence to their present age, and that the TUG was the strongest predictor for the 6MWT. This implicates the importance of focusing specifically on the different elements of functional mobility in further studies.

Assessing body composition in healthy newborn infants: reliability of dual-energy x-ray absorptiometry.

Dual-energy X-ray absorptiometry (DXA) is used to measure body composition in newborns; however, data on DXA accuracy are limited. We investigated the reliability of body composition measurements by DXA. The present study included 207 normal-term newborn babies, recruited from a larger study on the determinants of birth weight in healthy pregnancies (STORK) between 2005 and 2008. Reliability analysis of total fat mass (FM(DxA)), fat-free mass, lean mass (LM(DxA)), bone mineral content (BMC), and bone mineral density (BMD) were based on 2 DXA scans of 50 neonates. We also performed a comparison analysis for DXA (FM(DxA)) measurements and caliper (CLP) or circumference (CF) measurements of trunk and extremities (performed on all neonates, n=207). Reliability: All intraclass correlation coefficients (ICC) were satisfactory to excellent for total body and the extremity-compartment FM(DxA), LM(DxA), BMD, and BMC; ICC ranged from 0.86 to 0.96 but with a lower ICC for trunk FM(DxA). For comparison analysis, the Pearson correlation coefficients for CLP vs DXA and CF vs DXA ranged from 0.48 to 0.79 and 0.41 to 0.77, respectively. Quadriceps CLP and CF measurements correlated best with the most reliable DXA results, whereas more modest correlations were found for the trunk region. DXA measurements of body composition demonstrated good reliability and can be used as a reference method in neonates. CLP and CF measurements are appropriate for larger cohorts or when DXA is unavailable, and they provide fair rough estimations of fat mass.

Reliability and diagnostic characteristics of the JFK coma recovery scale-revised: exploring the influence of rater's level of experience.

OBJECTIVE: To confirm the reliability and diagnostic validity of the JFK Coma Recovery Scale-Revised (CRS-R) across raters with varying levels of experience. METHODS: Thirty-one patients with disorders of consciousness were recruited from 6 Norwegian hospitals. MAIN OUTCOME MEASURES: CRS-R and the Disability Rating Scale. RESULTS: Reliability measures were good for the CRS-R total scores and moderate to good for its subscales. Diagnostic agreement among examiners was good. Raters' experience with the CRS-R favorably influenced reliability. Sensitivity and specificity analyses demonstrated better detection of patients in minimally conscious state on the CRS-R relative to the Disability Rating Scale. CONCLUSIONS: The CRS-R is a reliable tool for diagnosing vegetative state and minimally conscious state. Raters' level of experience influences the reliability of the CRS-R scores.

Author Correction: Evaluation of Hypoglycaemia with Non-Invasive Sensors in People with Type 1 Diabetes and Impaired Awareness of Hypoglycaemia.

A correction to this article has been published and is linked from the HTML and PDF versions of this paper. The error has not been fixed in the paper.

Modifiable determinants of fetal macrosomia: role of lifestyle-related factors.

BACKGROUND: Newborn macrosomia is associated with both short- and long-term health risks for the infant, and increases the prevalence of birth complications. Parity, maternal age and gender of the child are known variables that influence fetal growth. The purpose of the present investigation was to evaluate prospectively the contributions of modifiable maternal predictors of fetal macrosomia (> or =4,200 g), which included lifestyle-related factors, such as nutritional intake, physical activity, and plasma glucose values, in addition to overweight and pregnancy weight gain. METHODS: Some 553 women were followed through pregnancy. Predictive variables were subjected to univariate and multiple logistic regression analysis. Among these were: body mass index (BMI), weight gain, maternal subcutaneous fat (mm), fasting and 2-h plasma glucose, self-reported physical activity before and during pregnancy, and nutritional intake of macronutrients. Gestational age, parity and gender were also included in the model. All continuous variables were dichotomized using the upper quartile as the cut-off point in most cases. RESULTS: If physical activity was left out of the analyses, BMI, weight gain, plasma glucose and gestational age were independent determinants of macrosomia. After including low level pre-gestational physical activity in the model, we found that this was now a significant determinant of delivering a macrosomic infant with an OR=2.9 (95% CI: 1.9, 7.3). CONCLUSION: The present study indicates that a low level of pre-gestational physical activity adds to the modifiable determinants of newborn macrosomia.

Evaluation of Hypoglycaemia with Non-Invasive Sensors in People with Type 1 Diabetes and Impaired Awareness of Hypoglycaemia.

People with type 1 diabetes and impaired awareness of hypoglycaemia (IAH) are prone to severe hypoglycaemia. Previous attempts to develop non-invasive hypoglycaemia alarm systems have shown promising results, but it is not known if such alarms can detect severe hypoglycaemia in people with IAH. We aimed to explore whether a combination of non-invasive sensors could reliably evaluate hypoglycaemia (plasma glucose (PG) minimum 2.5 mmol/L) in people with IAH. Twenty participants with type 1 diabetes and IAH underwent randomly ordered, single blinded hyperinsulinemic euglycaemic and hyperinsulinemic hypoglycaemic clamps. Sweating, skin temperature, ECG, counterregulatory hormones and symptoms of hypoglycaemia were assessed. Overall, we were not able to detect clamp-induced hypoglycaemia with sufficient sensitivity and specificity for further clinical use. As a post-hoc analysis, we stratified participants according to their ability to identify hypoglycaemic symptoms during hypoglycaemic clamps. Five out of 20 participants could identify such symptoms. These participants had a significantly higher adrenaline response to hypoglycaemia (p < 0.001) and were reliably identified by sensors. Based on our observations, a non-invasive alarm system based on measurement of sweating responses and ECG changes during hypoglycaemia might provide an alert at a plasma glucose concentration around 2.5 mmol/L if an adequate sympatho-adrenal reaction is elicited.

Genetic determinants of glucose levels in pregnancy: genetic risk scores analysis and GWAS in the Norwegian STORK cohort.

Objective Hyperglycaemia during pregnancy increases the risk of adverse health outcomes in mother and child, but the genetic aetiology is scarcely studied. Our aims were to (1) assess the overlapping genetic aetiology between the pregnant and non-pregnant population and (2) assess the importance of genome-wide polygenic contributions to glucose traits during pregnancy, by exploring whether genetic risk scores (GRSs) for fasting glucose (FG), 2-h glucose (2hG), type 2 diabetes (T2D) and BMI in non-pregnant individuals were associated with glucose measures in pregnant women. Methods We genotyped 529 Norwegian pregnant women and constructed GRS from known genome-wide significant variants and SNPs weakly associated (p > 5 × 10-8) with FG, 2hG, BMI and T2D from external genome-wide association studies (GWAS) and examined the association between these scores and glucose measures at gestational weeks 14-16 and 30-32. We also performed GWAS of FG, 2hG and shape information from the glucose curve during an oral glucose tolerance test (OGTT). Results GRSFG explained similar variance during pregnancy as in the non-pregnant population (~5%). GRSBMI and GRST2D explained up to 1.3% of the variation in the glucose traits in pregnancy. If we included variants more weakly associated with these traits, GRS2hG and GRST2D explained up to 2.4% of the variation in the glucose traits in pregnancy, highlighting the importance of polygenic contributions. Conclusions Our results suggest overlap in the genetic aetiology of FG in pregnant and non-pregnant individuals. This was less apparent with 2hG, suggesting potential differences in postprandial glucose metabolism inside and outside of pregnancy.

Patients with neuromuscular diseases benefit from treatment in a warm climate.

OBJECTIVE: Several studies have shown positive effects of treatment of chronic diseases in a warm climate. The aim of this study was to evaluate the long-term effect of a 4-week rehabilitation programme in a warm climate for patients with neuromuscular diseases. DESIGN: A randomized controlled trial with a cross-over design. One period of intervention and one period of "life as usual". PATIENTS: A total of 60 persons with a neuromuscular diagnosis. METHODS: Long-term effects were defined as changes in physical and psychological functions persisting after 3 months. Several scales were used according to the World Health Organization's classification of functioning. RESULTS: A comparison of the changes in the 2 periods showed significantly better results for all primary outcome scales in favour of the intervention. Mean difference in changes in pain (VAS scale), 6-min walking test and "timed up and go" were 9.0 (SD 28.8) units, 52 (75) m and 1.0 (2.3) sec, p = 0, 03, < 0.01 and 0.01, respectively. Median difference in changes in "Fatigue Severity Scale" and "Life Satisfaction Scale" were 0.4 (-0.5, 1.7) and 0.0 (0.0, 1.0), p = < 0.01 and 0.01, respectively. CONCLUSION: This study shows positive long-term effects on different dimensions of health after a 4-week rehabilitation programme in a warm climate for patients with neuromuscular diseases. This effect might be due to the programme, the warm climate, or a combination of both.

Ambulant adults with spastic cerebral palsy: the validity of lower limb joint angle measurements from sagittal video recordings.

BACKGROUND: In the development of a clinical program for ambulant adults with cerebral palsy (CP), we investigated the validity of joint angles measured from sagittal video recordings and explored if movements in the transversal plane identified with three-dimensional gait analysis (3DGA) affected the validity of sagittal video joint angle measurements. METHODS: Ten observers, and 10 persons with spastic CP (19-63 years), Gross Motor Function Classification System I-II, participated in the study. Concurrent criterion validity between video joint angle measurements and 3DGA was assessed by Bland-Altman plots with mean differences and 95% limits of agreement (LoA). Pearson's correlation coefficients (r) and scatter plots were used supplementary. Transversal kinematics ≥2 SD from our reference band were defined as increased movement in the transversal plane. RESULTS: The overall mean differences in degrees between joint angles measured by 3DGA and video recordings (3°, 5° and -7° for the hip, knee and ankle respectively) and corresponding LoA (18°, 10° and 15° for the hip, knee and ankle, respectively) demonstrated substantial discrepancies between the two methods. The correlations ranged from low (r=0.39) to moderate (r=0.68). Discrepancy between the two measurements was seen both among persons with and without the presence of deviating transversal kinematics. CONCLUSION: Quantifying lower limb joint angles from sagittal video recordings in ambulant adults with spastic CP demonstrated low validity, and should be conducted with caution. This gives implications for selecting evaluation method of gait.

A population-based study relevant to seasonal variations in causes of death in children undergoing surgery for congenital cardiac malformations.

AIMS: Our objectives were, first, to study seasonal distribution of perioperative deaths within 30 days after surgery, and late death, in children undergoing surgery for congenitally malformed hearts, and second, to study the causes of late death. METHODS: We analysed a retrospective cohort of 1,753 children with congenital cardiac malformations born and undergoing surgery in the period from 1990 through 2002 with a special focus on the causes of late death. The data was obtained from the registry of congenital cardiac malformations at Rikshospitalet, Oslo, and the Norwegian Medical Birth Registry. The mean follow-up from birth was 8.1 years, with a range from zero to 15.2 years. RESULTS: During the period of follow-up, 204 (11.6%) of the children died having undergone previous surgery. Of these 124 (7.1%) died in the perioperative period, and 80 (4.5%) were late deaths. There were 56 late deaths during the 6 coldest months, compared with 24 during the 6 warmest months (p < 0.01). There was no significant seasonal variation in perioperative deaths. Respiratory infection was the most common cause of late death, and occurred in 25 children, of whom 24 died during the 6 coldest months. Of the 8 sudden late deaths, 7 occurred during the 6 coldest months. There was no seasonal variation for the other causes of death. CONCLUSIONS: In children undergoing surgery for congenital cardiac malformations in Norway, there is a seasonal variation in late death, with a higher proportion occurring in the coldest months. Death related to respiratory infections predominantly occurs in the winter season, and is the overall most common cause of late death.