Parents Need More Support: A Qualitative Study of the Experiences of Australian Parents Who Are Waiting for Surgical Intervention for Their Children With Otitis Media.

OBJECTIVE: To explore the experiences, expectations, and motivations of parents/caregivers of children with otitis media who were booked to undergo tympanostomy tube insertion. METHOD: A cross-sectional cohort study was conducted using semistructured interviews with 39 parents. Interviews were conducted via telephone and analyzed for key themes. RESULTS: Three themes emerged that incorporated a range of subthemes: (1) the impact of the child's underlying condition on the family, (2) the cues and prompts that influenced parents to seek intervention, and (3) the parents' expectations of the health-care system. The child's otitis media disrupted the day-to-day functioning of the family and the child's well-being, but despite this, the families found ways to adapt and cope. Parents were influenced by their friends, family, and medical practitioners when making treatment decisions and had differing expectations of the health-care system. CONCLUSION: Parents need support during their child's illness to help with pressures placed on the family and also in making health-care decisions for their child. Clinicians should consider these issues when discussing treatment options with parents.

Gallbladder disease, cholecystectomy, and pancreatic cancer risk in the International Pancreatic Cancer Case-Control Consortium (PanC4).

BACKGROUND: The association among gallbladder disease, cholecystectomy, and pancreatic cancer is unclear. Moreover, time interval between gallbladder disease or cholecystectomy and pancreatic cancer diagnosis is not considered in most previous studies. AIM: To quantify the association among gallbladder disease, cholecystectomy, and pancreatic cancer, considering time since first diagnosis of gallbladder disease or cholecystectomy. METHODS: We used data from nine case-control studies within the Pancreatic Cancer Case-Control Consortium, including 5760 cases of adenocarcinoma of the exocrine pancreas and 8437 controls. We estimated pooled odds ratios and the corresponding 95% confidence intervals by estimating study-specific odds ratios through multivariable unconditional logistic regression models, and then pooling the obtained estimates using fixed-effects models. RESULTS: Compared with patients with no history of gallbladder disease, the pooled odds ratio of pancreatic cancer was 1.69 (95% confidence interval, 1.51-1.88) for patients reporting a history of gallbladder disease. The odds ratio was 4.90 (95% confidence interval, 3.45-6.97) for gallbladder disease diagnosed <2 years before pancreatic cancer diagnosis and 1.11 (95% confidence interval, 0.96-1.29) when ≥2 years elapsed. The pooled odds ratio was 1.64 (95% confidence interval, 1.43-1.89) for patients who underwent cholecystectomy, as compared to those without cholecystectomy. The odds ratio was 7.00 (95% confidence interval, 4.13-11.86) for a surgery <2 years before pancreatic cancer diagnosis and 1.28 (95% confidence interval, 1.08-1.53) for a surgery ≥2 years before. CONCLUSIONS: There appears to be no long-term effect of gallbladder disease on pancreatic cancer risk, and at most a modest one for cholecystectomy. The strong short-term association can be explained by diagnostic bias and reverse causation.

Menstrual and Reproductive Factors, Hormone Use, and Risk of Pancreatic Cancer: Analysis From the International Pancreatic Cancer Case-Control Consortium (PanC4).

OBJECTIVES: We aimed to evaluate the relation between menstrual and reproductive factors, exogenous hormones, and risk of pancreatic cancer (PC). METHODS: Eleven case-control studies within the International Pancreatic Cancer Case-control Consortium took part in the present study, including in total 2838 case and 4748 control women. Pooled estimates of odds ratios (ORs) and their 95% confidence intervals (CIs) were calculated using a 2-step logistic regression model and adjusting for relevant covariates. RESULTS: An inverse OR was observed in women who reported having had hysterectomy (ORyesvs.no, 0.78; 95% CI, 0.67-0.91), remaining significant in postmenopausal women and never-smoking women, adjusted for potential PC confounders. A mutually adjusted model with the joint effect for hormone replacement therapy (HRT) and hysterectomy showed significant inverse associations with PC in women who reported having had hysterectomy with HRT use (OR, 0.64; 95% CI, 0.48-0.84). CONCLUSIONS: Our large pooled analysis suggests that women who have had a hysterectomy may have reduced risk of PC. However, we cannot rule out that the reduced risk could be due to factors or indications for having had a hysterectomy. Further investigation of risk according to HRT use and reason for hysterectomy may be necessary.

Visual evoked potential latencies of three-year-old children prenatally exposed to buprenorphine or methadone compared with non-opioid exposed children: The results of a longitudinal study.

This study compared the latency of pattern reversal visual evoked potentials (VEP) of 36-month old children exposed to opioid pharmacotherapy in utero to that of a group of non-exposed children. Pregnant women were enrolled as part of an open-label non-randomised flexible dosing longitudinal study. Participants were 21 children whose mothers were treated with buprenorphine- (n=11) or methadone-pharmacotherapy (n=10) during pregnancy, and 15 children not exposed to opioids in pregnancy. One-way between groups analyses of variance (ANOVA) were conducted to test the statistical significance of differences between the mean latencies of the peak response to two different sized checkerboard patterns (48' and 69' of retinal arc). Standard multiple regression analyses were conducted to determine whether there was a significant relationship between group status and VEP latencies after adjusting for the effect of covariates. VEP latencies ranged from 98 to 112 milliseconds (ms) for checks of 48' arc, and from 95 to 113ms for checks of 69' arc. Latencies were comparable across groups. After adjusting for covariates children prenatally exposed to methadone or buprenorphine did not differ significantly from non-opioid exposed children in their responses to either check size. Nor were there any significant differences in VEP latencies between children prenatally exposed to methadone and children prenatally exposed to buprenorphine. Head circumference (HC) was significantly associated with P100 latencies for both check sizes. Data from this controlled, non-randomised study suggest that neither buprenorphine nor methadone appear to have any long-term effects on visual maturity assessed at 36months of age.

The Minimum Duration of Sensor Data From Which Glycemic Variability Can Be Consistently Assessed.

Despite much discussion regarding the clinical relevance of glycemic variation (GV), little discourse has addressed the properties of the data set from which it is derived. We aimed to assess the minimum duration of data required using continuous glucose monitoring (CGM) that most closely approximates to a gold standard 90-day measure. Data from 20 children and adolescents with type 1 diabetes were examined. All participants had CGM data sets of 90 days duration, from which standard deviation (SD), coefficient of variation (CV), mean amplitude of glycemic action (MAGE), and continuous overlapping net glycemic action (CONGA1-8) were calculated for the overall period and then investigational periods of 2, 4, 6, 12, 18, 24, and 30 days. The percentage difference between each measure and the overall measure per time period was assessed. As the duration of the CGM data set increased, the percentage error continued to decrease, giving a metric approximating more closely toward the overall measure. Median SD and CV differed from the overall measure by <10% at 12 days duration. The frequency of interruptions to the CGM trace rendered MAGE and CONGA unreliable, hence SD and CV were reported. We suggest that data sets used to infer GV should be of a minimum duration of 12 days. MAGE and CONGA exhibit poor performance in the setting of frequent trace interruption.

Development of paediatric biochemistry centile charts as a complement to laboratory reference intervals.

Age-specific paediatric reference intervals are used in interpretation of laboratory results. However, interpretation may be problematic when a child just crosses an age bracket and the difference between the original and the subsequent age-specific reference interval is large. Moreover, details about the physiological changes with age may be masked. For the 12 months ending 30 September 2013, results of 16 common clinical biochemistry tests of ambulatory paediatric patients aged 0-19, requested by primary care physicians, were retrospectively collected in a large pathology service, and used to construct smoothed centile charts using a penalised maximum likelihood method. From the developed centile charts, the concentrations of sodium, bicarbonate, creatinine, urate, total protein, and albumin all increased with increasing age of the children. In contrast, the concentrations of potassium, chloride, anion gap, calcium, phosphate and lactate dehydrogenase decreased with increasing age of the children. Changes in the concentrations of urea, alkaline phosphatase, glucose, and total cholesterol varied by age. Generally, the boys and girls shared similar trend patterns until 10-15 years of age, when variations in the age of onset of puberty and development caused the trends of some biochemical measures to differ. The paediatric biochemistry centile charts are intuitive tools to use. They complement age-specific reference intervals in the tracking, interpretation and discussion of laboratory results. They also enhance the understanding of underlying physiological changes in biochemistry in children.

Tracing the long-term legacy of childhood lead exposure: a review of three decades of the port Pirie cohort study.

Several prospective cohort studies have demonstrated that childhood lead levels show small but statistically significant adjusted associations with subsequent development in later childhood and adolescence. The Port Pirie Cohort study is one of the few prospective cohort studies to follow participants into adulthood. This paper reviews all childhood and adulthood findings of the Port Pirie Cohort study to date. Cohort members (initially, 723 infants born in/around the lead-smelting town of Port Pirie) showed a wide range of childhood blood lead levels, which peaked around 2 years old (M=21.3µg/dL, SD=1.2). At all childhood assessments, postnatal lead levels - particularly those reflecting cumulative exposure - showed small significant associations with outcomes including cognitive development, IQ, and mental health problems. While associations were substantially attenuated after adjusting for several childhood covariates, many remained statistically significant. Furthermore, average childhood blood lead showed small significant associations with some adult mental health problems for females, including anxiety problems and phobia, though associations only approached significance following covariate adjustment. Overall, there did not appear to be any age of greatest vulnerability or threshold of effect, and at all ages, females appeared more susceptible to lead-associated deficits. Together, these findings suggest that the associations between early childhood lead exposure and subsequent developmental outcomes may persist. However, as the magnitude of these effects was small, they are not discernible at the individual level, posing more of a population health concern. It appears that the combination of multiple early childhood factors best predicts later development. As such, minimising lead exposure in combination with improving other important early childhood factors such as parent-child interactions may be the best way to improve developmental outcomes.

The association between increasing maternal age at first birth and decreased rates of spontaneous vaginal birth in South Australia from 1991 to 2009.

BACKGROUND: Caesarean section rates in Australia rose over the period 1999-2009, as did maternal age at first birth. The contribution of the rise of maternal age to the rise in caesarean sections remains unclear. AIMS: To estimate the effect of increasing maternal age on the incidence of emergency caesarean section or instrumental delivery in term singleton first births in South Australia. METHODS: We undertook a population-based study of 117 981 term singleton first births, which followed labour during the period 1991-2009, using data from the South Australian Perinatal Statistics Collection. The main outcome measures were deliveries other than spontaneous vaginal births (SVB) (emergency caesarean section or instrumental birth) and emergency caesarean section alone. Logistic regression analysis was performed. RESULTS: Increasing maternal age at first birth was found to be associated with delivery other than SVB and emergency caesarean section. The adjusted odds of delivery other than SVB increased multiplicatively by approximately 1.49 (95% CI, 1.47-1.51) per five-year rise in maternal age, and the odds of emergency caesarean section increased multiplicatively by approximately 1.39 (95% CI, 1.37-1.42) per five-year rise. Although there are likely to be many reasons for the effect, increases in maternal age at first birth made a contribution in up to 75% of the observed increase in delivery other than SVB from 44.0% to 49.6% over the study period. CONCLUSIONS: Rising maternal age at first birth appeared to contribute to a large proportion of the increase in deliveries other than SVB in South Australia.

Consumer reporting of adverse events following immunization (AEFI): identifying predictors of reporting an AEFI.

Passive reporting of adverse events following immunization (AEFI) by consumers or healthcare professionals is the primary mechanism for post-marketing surveillance of vaccine safety. Although recent initiatives have promoted consumer reporting, there is a lack of research concerning consumer reporters. Computer assisted telephone interviews (CATI) were conducted in 2011 of a cross-sectional, random, general population sample of 191 South Australian parents who stated that their children had previously experienced an AEFI. We compared awareness of surveillance, vaccine safety opinions, and demographics of parents reporting an AEFI to either healthcare professionals or surveillance authorities with those who did not report their children's AEFI. Multivariate regression analyses measured: the association between reporting and safety views; and demographic predictors of reporting an AEFI. Reporting an AEFI to a healthcare professional or a surveillance authority was not significantly associated with awareness of a surveillance system. AEFI reporters, when compared with non-reporters, were more likely to be Australian-born (OR = 4.58, [1.64, 12.78], P = 0.004); were associated with the perception that a serious reaction was more likely to occur at their children's last immunization (OR = 2.54 [95%CI 1.22, 5.30], P = 0.013); and were less accepting of the risk of febrile convulsion, (OR = 3.59 [95%CI 1.50, 8.57], P = 0.004). Although reporting an AEFI was not associated with awareness of surveillance or most socio-demographics, the results suggest some difference in safety opinions. Further studies are required to ascertain if these differences pre-date the occurrence of an AEFI or are a consequence of the AEFI and how consumers can contribute further to vaccine safety surveillance.

Can screening 4-5 year olds accurately identify children who will have teacher-reported mental health problems when children are aged 6-7 years?

OBJECTIVE: To assess the screening accuracy of information obtained from parents of 4-5-year-old children for the purpose of identifying the children who have teacher-reported mental health problems when they are aged 6-7 years. METHOD: The study used data from the Longitudinal Study of Australian Children (LSAC) obtained when children were aged 4-5 years and 6-7 years. The level of children's mental health problems was assessed using the Strengths and Difficulties Questionnaire (SDQ) completed by parents when children were aged 4-5 years and by teachers when children were aged 6-7 years (n=2163). When children were aged 4-5 years, parenting skills were assessed using three questionnaires developed for the parent-completed LSAC questionnaire and maternal mental health was assessed using the Kessler Psychological Distress Scale (K6). RESULTS: When the level of parent-reported childhood mental health problems at 4-5 years old was used to identify children with teacher-reported mental health problems (i.e. a score in the "abnormal" range of the teacher-reported SDQ Total Difficulties Scale) when the children were aged 6-7 years, sensitivity was 26.8%, positive predictive value was 22.8%, and specificity was 92.9%. The addition of further information about the characteristics of children and their parents made only a small improvement to screening accuracy. CONCLUSIONS: Targeted interventions for preschool children may have the potential to play an important role in reducing the prevalence of mental health problems during the early school years. However, current capacity to accurately identify preschoolers who will experience teacher-reported mental health problems during the early school years is limited.

Prospective associations between childhood low-level lead exposure and adult mental health problems: the Port Pirie cohort study.

Low-level environmental lead exposure during childhood is associated with poorer emotional/behavioural functioning in later childhood and adolescence. Scarce research has examined whether these apparent effects persist into adulthood. This study is the first to examine prospective associations between lead exposure across early childhood and several common adult mental health problems. Childhood data (including blood lead concentrations) and adult data (from mental health questionnaires and psychiatric interviews) were available for 210 participants (44% males, mean age=26.3 years) from the Port Pirie cohort study (1979-1982 birth cohort). Participants had a mean childhood (to 7 years) average blood lead concentration of 17.2µg/dL. Among females, childhood blood lead showed small significant positive associations with lifetime diagnoses of drug and alcohol abuse and social phobia, and with anxiety, somatic and antisocial personality problems. For example: for a 10µg/dL blood lead increase, females were 2.84 times (95% CI 1.10, 7.30) more likely to have an alcohol abuse diagnosis. However, adjustment for childhood covariates - particularly stimulation within the home environment - rendered these associations non-significant. No significant or sizeable unadjusted or adjusted associations were seen for males. The associations between early lead exposure and emotional/behavioural functioning in children might persist into adulthood, at least for females. However, it is unclear whether such results arise from residual confounding, or other mechanisms. Interventions that focus on improving the childhood home environment may have a long-term positive impact on adult mental health outcomes. However, more prospective research using large and representative samples is needed to substantiate these results.

Healthcare providers' knowledge, experience and challenges of reporting adverse events following immunisation: a qualitative study.

BACKGROUND: Healthcare provider spontaneous reporting of suspected adverse events following immunisation (AEFI) is central to monitoring post-licensure vaccine safety, but little is known about how healthcare professionals recognise and report to surveillance systems. The aim of this study was explore the knowledge, experience and attitudes of medical and nursing professionals towards detecting and reporting AEFI. METHODS: We conducted a qualitative study, using semi-structured, face to face interviews with 13 Paediatric Emergency Department consultants from a tertiary paediatric hospital, 10 General Practitioners, 2 local council immunisation and 4 General Practice nurses, recruited using purposive sampling in Adelaide, South Australia, between December 2010 and September 2011. We identified emergent themes related to previous experience of an AEFI in practice, awareness and experience of AEFI reporting, factors that would facilitate or impede reporting and previous training in vaccine safety. Thematic analysis was used to analyse the data. RESULTS: AEFI reporting was infrequent across all groups, despite most participants having reviewed an AEFI. We found confusion about how to report an AEFI and variability, according to the provider group, as to the type of events that would constitute a reportable AEFI. Participants' interpretation of a "serious" or "unexpected" AEFI varied across the three groups. Common barriers to reporting included time constraints and unsatisfactory reporting processes. Nurses were more likely to have received formal training in vaccine safety and reporting than medical practitioners. CONCLUSIONS: This study provides an overview of experience and beliefs of three healthcare professional groups in relation to identifying and reporting AEFI. The qualitative assessment reveals differences in experience and awareness of AEFI reporting across the three professional groups. Most participants appreciated the importance of their role in AEFI surveillance and monitoring the ongoing safety of vaccines. Future initiatives to improve education, such as increased training to health care providers, particularly, medical professionals, are required and should be included in both undergraduate curricula and ongoing, professional development.

Genetic and clinical contributions to cerebral palsy: a multi-variable analysis.

AIM: This study aims to examine single nucleotide polymorphism (SNP) associations with cerebral palsy in a multi-variable analysis adjusting for potential clinical confounders and to assess SNP-SNP and SNP-maternal infection interactions as contributors to cerebral palsy. METHODS: A case control study including 587 children with cerebral palsy and 1154 control children without cerebral palsy. Thirty-nine candidate SNPs were genotyped in both mother and child. Data linkage to perinatal notes and cerebral palsy registers was performed with a supplementary maternal pregnancy questionnaire. History of known maternal infection during pregnancy was extracted from perinatal databases. RESULTS: Both maternal and fetal carriage of inducible nitric oxide synthase SNP rs1137933 were significantly negatively associated with cerebral palsy in infants born at less than 32 weeks gestation after adjustment for potential clinical confounders and correction for multiple testing (odds ratio 0.55, 95% confidence interval 0.38-0.79; odds ratio 0.57, 95% confidence interval 0.4-0.82, respectively). Analysis did not show any statistically significant SNP-SNP or SNP-maternal infection interactions after correction for multiple testing. CONCLUSIONS: Maternal and child inducible nitric oxide synthase SNPs are associated with reduced risk of cerebral palsy in infants born very preterm. There was no evidence for statistically significant SNP-SNP or SNP-maternal infection interactions as modulators of cerebral palsy risk.

Vascular function and glucose variability improve transiently following initiation of continuous subcutaneous insulin infusion in children with type 1 diabetes.

OBJECTIVE: The effect of continuous subcutaneous insulin infusion (CSII) and glucose variability on vascular health in type 1 diabetes (T1D) is not known. We aimed to determine whether initiation of CSII improves vascular function and reduces glucose variability, independent of changes in HbA1c. METHODS: Twenty-two children with T1D (12.5 ± 2.9 yr) were reviewed immediately prior, 3 wk, and 12 months after initiation of CSII. Vascular function [flow-mediated dilatation (FMD), glyceryl trinitrate-mediated dilatation (GTN)], glucose variability [mean of daily differences (MODD), mean amplitude of glycaemic excursions (MAGE) and continuous overlapping net glycaemic action (CONGA)], and clinical and biochemical data were measured at each visit. Results for the first two visits were compared to a previously studied cohort of 31 children with T1D who remained on multiple daily injections (MDI). RESULTS: FMD, GTN, blood pressure, HbA1c, fructosamine, and glucose variability significantly improved 3 wk after CSII commencement (all p < 0.05), but there was no change in the MDI control group. At 3 wk, vascular function related to glucose variability [(FMD: MODD, r = -0.62, p = 0.002) and (GTN: MAGE, r = -0.59, p = 0.004; CONGA-4, r = -0.51, p = 0.01; MODD, r = -0.62, p = 0.002)] but not to blood pressure, HbA1c, or fructosamine. At 12 months, FMD, GTN, blood pressure, and glucose variability returned to baseline levels, while HbA1c deteriorated. Carotid intima media thickness was unchanged over 12 months. CONCLUSIONS: Initiation of CSII rapidly improves vascular function in association with decreased glucose variability; however, the effects are not sustained with deterioration of metabolic control and glucose variability.

Resource factors for mental health resilience in early childhood: An analysis with multiple methodologies.

BACKGROUND: Given that relatively little is known about the development of resilience in early childhood, this longitudinal study aimed to identify preschool resource factors associated with young children's mental health resilience to family adversity. METHODS: A community sample of 474 young Australian children was assessed in preschool (mean age 4.59 years, 49% male), and again two years later after their transition into formal schooling. At each assessment, standard questionnaires were used to obtain ratings from both parents and teachers about the quality of children's relationships with parents and teachers, children's self-concept and self-control, mental health (Strengths and Difficulties Questionnaire), and family adversities (including stressful life events and socioeconomic disadvantage). RESULTS: Greater exposure to cumulative family adversities was associated with both greater teacher- and parent-reported child mental health difficulties two years later. Multiple methodologies for operationalizing resilience were used to identify resources associated with resilient mental health outcomes. Higher quality child-parent and child-teacher relationships, and greater child self-concept and self-control were associated with resilient mental health outcomes. With the exception of child-teacher relationships, these resources were also prospective antecedents of subsequent resilient mental health outcomes in children with no pre-existing mental health difficulties. Child-parent relationships and child self-concept generally had promotive effects, being equally beneficial for children facing both low- and high-adversity. Child self-control demonstrated a small protective effect on teacher-reported outcomes, with greater self-control conferring greater protection to children under conditions of high-adversity. CONCLUSIONS: Findings suggest that early intervention and prevention strategies that focus on fostering child-adult relationship quality, self-concept, and self-control in young children may help build children's mental health and their resilience to family adversities.

Parental perspectives of vaccine safety and experience of adverse events following immunisation.

INTRODUCTION: We aimed to determine demographic predictors of parental vaccine safety and risk perceptions, and assess the relationship between the occurrence of children's perceived adverse events following immunisation (AEFI) on parents' opinions. METHODS: Computer-assisted telephone interviews (CATI) were conducted in 2011 with a cross-sectional, random general population sample of rural and metropolitan residents in South Australia. Multivariate ordinal logistic regression analyses examined associations between parental vaccine safety attitudes and socio-demographic factors, adjusting for whether children had ever experienced a previous suspected AEFI. RESULTS: Of 469 parents interviewed, 95% were confident in vaccine safety in general, but almost half expressed concern for pre-licensure testing of vaccines. Of all parents, 41% responded that at least one of their children had experienced an AEFI. Almost one third of the AEFI parent group indicated they reported their children's symptoms to either a healthcare professional or the Department of Health. Parental acceptability of the risks of febrile convulsion and anaphylaxis were 73% and 76% respectively. Ordinal logistic regression analyses showed parents of children who had experienced a suspected AEFI were associated with greater concern for vaccine safety (OR:0.53, p≤0.01) and more were likely to expect either a mild or a serious AEFI. After adjusting for demographics, parental confidence in vaccine safety was significantly associated with higher levels of education (OR:2.58, p=0.01) and being born in Australia OR:2.30, p=0.004. Mothers, when compared with fathers, were less accepting of the two vaccine risks presented: febrile convulsion (OR:0.57, p=0.04) and anaphylaxis, (OR:0.55, p=0.04). CONCLUSIONS: Parents commonly perceive and report that their child has experienced an AEFI. In this group of parents the subsequent expectation of an AEFI and vaccine safety concerns may be heightened. Further research should investigate parental understandings of differentiating an expected event from an adverse event as this could inform immunization risk communication and consumer AEFI reporting strategies.

The case for retaining severe perineal tears as an indicator of the quality of obstetric care.

BACKGROUND: The incidence of severe perineal tears acquired during vaginal childbirth varies considerably across hospitals but its use as a safety and quality indicator is in jeopardy because of problems associated with accurate detection and recording. AIM: To understand and interpret time trends in the incidence of third- and fourth-degree perineal tears among women giving birth vaginally in 18 public maternity hospitals in South Australia, taking into account individualised risk factors for each birth. METHODS: The risk-adjusted probability of a third- and fourth-degree tear was estimated for each of 65,598 singleton vaginal births (2002-2008), using a previously published regression model. The risk factors for each birth included maternal age; parity and ethnicity; assistance with instruments and episiotomy; shoulder dystocia; and infant birthweight. Plots of 'excess' tears were generated to help identify maternity services where the observed incidence of severe trauma differed from the expectation estimated from the risk profiles. RESULTS: Three hospitals were identified at which there were systematically more tears than expected (given their risk profiles), and five hospitals were identified at which there were fewer tears. However, increased tearing at two hospitals coincided closely with improved advocacy for better detection and treatment of perineal tears (especially partial third-degree tears). CONCLUSION: Statistical process control methods provide a powerful means of investigating temporal variations in the incidence of outcomes like severe perineal tears. Third- or fourth- degree tears should be retained as a quality indicator of maternity services, but it is likely that many third-degree tears currently go undetected.

The IDEAL study: investigation of dietary advice and lifestyle for women with borderline gestational diabetes: a randomised controlled trial - study protocol.

BACKGROUND: The Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) showed that treatment of pregnant women with mild gestational diabetes mellitus is beneficial for both women and their infants. It is still uncertain whether there are benefits of similar treatment for women with borderline gestational diabetes.This trial aims to assess whether dietary and lifestyle advice and treatment given to pregnant women who screen for borderline gestational diabetes reduces neonatal complications and maternal morbidities. DESIGN: Multicentre, randomised controlled trial. INCLUSION CRITERIA: Women between 240 and 346 weeks gestation with a singleton pregnancy, a positive oral glucose challenge test (venous plasma glucose ≥7.8 mmol/L) and a normal oral 75 gram glucose tolerance test (fasting venous plasma glucose <5.5 mmol/L and a 2 hour glucose <7.8 mmol/L) with written, informed consent.Trial entry and randomisation: Women with an abnormal oral glucose tolerance test (fasting venous plasma glucose ≥5.5 mmol/L or 2 hour glucose ≥7.8 mmol/L) will not be eligible and will be offered treatment for gestational diabetes, consistent with recommendations based on results of the ACHOIS trial. Eligible women will be randomised into either the 'Routine Care Group' or the 'Intervention Group'.Study groups: Women in the 'Routine Care Group' will receive routine obstetric care reflecting current clinical practice in Australian hospitals. Women in the 'Intervention Group' will receive obstetric care, which will include dietary and lifestyle advice, monitoring of blood glucose and further medical treatment for hyperglycaemia as appropriate.Primary study outcome: Incidence of large for gestational age infants. SAMPLE SIZE: A sample size of 682 women will be sufficient to show a 50% reduction in the risk of large for gestational age infants (alpha 0.05 two-tailed, 80% power, 4% loss to follow up) from 14% to 7% with dietary and lifestyle advice and treatment. DISCUSSION: A conclusive trial outcome will provide reliable evidence of relevance for the care of women with borderline glucose intolerance in pregnancy and their infants. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry - ACTRN12607000174482.

Risk models for benchmarking severe perineal tears during vaginal childbirth: a cross-sectional study of public hospitals in South Australia, 2002-08.

BACKGROUND: The incidence of third- and fourth-degree perineal tears during vaginal childbirth is being increasingly used as an indicator of the safety and quality of maternity health care services. In order to make fair comparisons across hospitals it may be necessary to estimate a probability of severe perineal tears for every woman, taking into account her risk profile. METHODS: Logistic regression analysis was used to estimate the probabilities of third- and fourth-degree tears (n = 1582; 2.4%) in 65 598 vaginal births in publicly funded hospitals in South Australia, 2002-08. RESULTS: Maternal age ≥25 years, primiparity, instrument assistance, Asian or African ethnicity, shoulder dystocia and increasing birthweight were all identified as factors that are associated with an increased risk of perineal tears. In parous women, episiotomy, with or without instrument assistance, was associated with more tears; but among nulliparous women, episiotomy was associated with significantly fewer tears when forceps assistance was required, and showed little or no association with tearing in vacuum-assisted or unassisted (spontaneous) births. CONCLUSION: The probabilities of severe perineal tears in first-time mothers giving birth to a term singleton with cephalic presentation, may range from under 1% to over 40%, according to a minimalist model containing only predictors unrelated to clinical management. If instrument assistance and episiotomy are also incorporated into the modelling, the estimated probability of tearing may exceed 50% in high risk individuals. Such variation highlights the need for risk adjustment when comparing hospitals with respect to their incidence of third or fourth degree perineal tears.