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1.  Safety and efficacy of antenatal milk expressing for women with diabetes in pregnancy: protocol for a randomised controlled trial 
BMJ Open  2014;4(10):e006571.
Many maternity providers recommend that women with diabetes in pregnancy express and store breast milk in late pregnancy so breast milk is available after birth, given (1) infants of these women are at increased risk of hypoglycaemia in the first 24 h of life; and (2) the delay in lactogenesis II compared with women without diabetes that increases their infant's risk of receiving infant formula. The Diabetes and Antenatal Milk Expressing (DAME) trial will establish whether advising women with diabetes in pregnancy (pre-existing or gestational) to express breast milk from 36 weeks gestation increases the proportion of infants who require admission to special or neonatal intensive care units (SCN/NICU) compared with infants of women receiving standard care. Secondary outcomes include birth gestation, breastfeeding outcomes and economic impact.
Methods and analysis
Women will be recruited from 34 weeks gestation to a multicentre, two arm, unblinded randomised controlled trial. The intervention starts at 36 weeks. Randomisation will be stratified by site, parity and diabetes type. Women allocated to the intervention will be taught expressing and encouraged to hand express twice daily for 10 min and keep an expressing diary. The sample size of 658 (329 per group) will detect a 10% difference in proportion of babies admitted to SCN/NICU (85% power, α 0.05). Data are collected at recruitment (structured questionnaire), after birth (abstracted from medical record blinded to group), and 2 and 12 weeks postpartum (telephone interview). Data analysis: the intervention group will be compared with the standard care group by intention to treat analysis, and the primary outcome compared using χ2 and ORs.
Ethics and dissemination
Research ethics approval will be obtained from participating sites. Results will be published in peer-reviewed journals and presented to clinicians, policymakers and study participants.
Trial registration number
Australian Controlled Trials Register ACTRN12611000217909.
PMCID: PMC4216858  PMID: 25358679
2.  Study protocol: Asking QUestions about Alcohol in pregnancy (AQUA): a longitudinal cohort study of fetal effects of low to moderate alcohol exposure 
Despite extensive research, a direct correlation between low to moderate prenatal alcohol exposure (PAE) and Fetal Alcohol Spectrum Disorders has been elusive. Conflicting results are attributed to a lack of accurate and detailed data on PAE and incomplete information on contributing factors. The public health effectiveness of policies recommending complete abstinence from alcohol during pregnancy is challenged by the high frequency of unplanned pregnancies, where many women consumed some alcohol prior to pregnancy recognition. There is a need for research evidence emphasizing timing and dosage of PAE and its effects on child development.
Asking QUestions about Alcohol (AQUA) is a longitudinal cohort aiming to clarify the complex effects of low to moderate PAE using specifically developed and tested questions incorporating dose, pattern and timing of exposure. From 2011, 2146 pregnant women completed a questionnaire at 8-18 weeks of pregnancy. Further prenatal data collection took place via a questionnaire at 26-28 weeks and 35 weeks gestation. Extensive information was obtained on a large number of risk factors to assist in understanding the heterogeneous nature of PAE effects. 1571 women (73%) completed all three pregnancy questionnaires. A biobank of DNA from maternal and infant buccal cells, placental biopsies and cord blood mononuclear cells will be used to examine epigenetic state at birth as well as genetic factors in the mother and child. Participants will be followed up at 12 and 24 months after birth to assess child health and measure infant behavioural and sensory difficulties, as well as family environment and parenting styles. A subgroup of the cohort will have 3D facial photography of their child at 12 months and a comprehensive developmental assessment (Bayley Scales of Infant & Toddler Development, Bayley-III) at two years of age.
Using detailed, prospective methods of data collection, the AQUA study will comprehensively examine the effects of low to moderate alcohol consumption throughout pregnancy on child health and development, including the role of key mediators and confounders. These data will ultimately contribute to policy review and development, health professional education and information about alcohol consumption for pregnant women in the future.
PMCID: PMC4168250  PMID: 25187010
Prenatal alcohol exposure; Fetal alcohol spectrum disorders; Cohort studies; Epidemiology; Pregnancy; Child health; Genetics; Epigenetics
3.  A prospective observational study to assess the diagnostic accuracy of clinical decision rules for children presenting to emergency departments after head injuries (protocol): the Australasian Paediatric Head Injury Rules Study (APHIRST) 
BMC Pediatrics  2014;14:148.
Head injuries in children are responsible for a large number of emergency department visits. Failure to identify a clinically significant intracranial injury in a timely fashion may result in long term neurodisability and death. Whilst cranial computed tomography (CT) provides rapid and definitive identification of intracranial injuries, it is resource intensive and associated with radiation induced cancer. Evidence based head injury clinical decision rules have been derived to aid physicians in identifying patients at risk of having a clinically significant intracranial injury. Three rules have been identified as being of high quality and accuracy: the Canadian Assessment of Tomography for Childhood Head Injury (CATCH) from Canada, the Children’s Head Injury Algorithm for the Prediction of Important Clinical Events (CHALICE) from the UK, and the prediction rule for the identification of children at very low risk of clinically important traumatic brain injury developed by the Pediatric Emergency Care Applied Research Network (PECARN) from the USA. This study aims to prospectively validate and compare the performance accuracy of these three clinical decision rules when applied outside the derivation setting.
This study is a prospective observational study of children aged 0 to less than 18 years presenting to 10 emergency departments within the Paediatric Research in Emergency Departments International Collaborative (PREDICT) research network in Australia and New Zealand after head injuries of any severity. Predictor variables identified in CATCH, CHALICE and PECARN clinical decision rules will be collected. Patients will be managed as per the treating clinicians at the participating hospitals. All patients not undergoing cranial CT will receive a follow up call 14 to 90 days after the injury. Outcome data collected will include results of cranial CTs (if performed) and details of admission, intubation, neurosurgery and death. The performance accuracy of each of the rules will be assessed using rule specific outcomes and inclusion and exclusion criteria.
This study will allow the simultaneous comparative application and validation of three major paediatric head injury clinical decision rules outside their derivation setting.
Trial registration
The study is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR)- ACTRN12614000463673 (registered 2 May 2014).
PMCID: PMC4074143  PMID: 24927811
Head injury; Clinical decision rule; Computed tomography; Validation
4.  Improving family communication after a new genetic diagnosis: a randomised controlled trial of a genetic counselling intervention 
BMC Medical Genetics  2014;15:33.
Genetic information given to an individual newly diagnosed with a genetic condition is likely to have important health implications for other family members. The task of communicating with these relatives commonly falls to the newly diagnosed person. Talking to relatives about genetic information can be challenging and is influenced by many factors including family dynamics. Research shows that many relatives remain unaware of relevant genetic information and the possible impact on their own health. This study aims to evaluate whether a specific genetic counselling intervention for people newly diagnosed with a genetic condition, implemented over the telephone on a number of occasions, could increase the number of at-risk relatives who make contact with genetics services after a new genetic diagnosis within a family.
This is a prospective, multi-centre randomised controlled trial being conducted at genetics clinics at five public hospitals in Victoria, Australia. A complex genetic counselling intervention has been developed specifically for this trial. Probands (the first person in a family to present with a diagnosis of a genetic condition) are being recruited and randomised into one of two arms – the telephone genetic counselling intervention arm and the control arm receiving usual care. The number of at-risk relatives for each proband will be estimated from a family pedigree collected at the time of diagnosis. The primary outcome will be measured by comparing the proportion of at-risk relatives in each arm of the trial who make subsequent contact with genetics services.
This study, the first randomised controlled trial of a complex genetic counselling intervention to enhance family communication, will provide evidence about how best to assist probands to communicate important new genetic information to their at-risk relatives. This will inform genetic counselling practice in the context of future genomic testing.
Trial registration
Australia and New Zealand Clinical Trials Register (ANZCTR): ANZCTRN12608000642381.
PMCID: PMC3995589  PMID: 24628824
Genetic counselling; Family communication; Genetic diagnosis; Disclosure
5.  Nipple Pain, Damage, and Vasospasm in the First 8 Weeks Postpartum 
Breastfeeding Medicine  2014;9(2):56-62.
Background: Nipple pain and damage are common in the early postpartum period and are associated with early cessation of breastfeeding and comorbidities such as depression, anxiety, and mastitis. The incidence of nipple vasospasm has not been reported previously. This article describes nipple pain and damage prospectively in first-time mothers and explores the relationship between method of birth and nipple pain and/or damage.
Subjects and Methods: A prospective cohort of 360 primiparous women was recruited in Melbourne, Australia, in the interval 2009–2011, and after birth participants were followed up six times. The women completed a questionnaire about breastfeeding practices and problems at each time point. Pain scores were graphically represented using spaghetti plots to display each woman's experience of pain over the 8 weeks of the study.
Results: After birth, before they were discharged home from hospital, 79% (250/317) of the women in this study reported nipple pain. Over the 8 weeks of the study 58% (198/336) of women reported nipple damage, and 23% (73/323) reported vasospasm. At 8 weeks postpartum 8% (27/340) of women continued to report nipple damage, and 20% (68/340) were still experiencing nipple pain. Ninety-four percent (320/340) of the women were breastfeeding at the end of the study, and there was no correlation between method of birth and nipple pain and/or damage.
Conclusions: Nipple pain is a common problem for new mothers in Australia and often persists for several weeks. Further studies are needed to establish the most effective means of preventing and treating breastfeeding problems in the postnatal period.
PMCID: PMC3934541  PMID: 24380583
6.  Does Candida and/or Staphylococcus play a role in nipple and breast pain in lactation? A cohort study in Melbourne, Australia 
BMJ Open  2013;3(3):e002351.
To investigate Candida species and Staphylococcus aureus and the development of ‘nipple and breast thrush’ among breastfeeding women.
Prospective longitudinal cohort study.
Two hospitals in Melbourne, Australia (one public, one private) with follow-up in the community.
360 nulliparous women recruited at ≥36 weeks’ gestation from November 2009 to June 2011. Participants were followed up six times: in hospital, at home weekly until 4 weeks postpartum and by telephone at 8 weeks.
Main outcome measures
Case definition ‘nipple and breast thrush’: burning nipple pain and breast pain (not related to mastitis); detection of Candida spp (using culture and PCR) in the mother's vagina, nipple or breast milk or in the baby's mouth; detection of S aureus in the mother's nipple or breast milk.
Women with the case definition of nipple/breast thrush were more likely to have Candida spp in nipple/breast milk/baby oral samples (54%) compared to other women (36%, p=0.014). S aureus was common in nipple/breast milk/baby samples of women with these symptoms as well as women without these symptoms (82% vs 79%) (p=0.597). Time-to-event analysis examined predictors of nipple/breast thrush up to and including the time of data collection. Candida in nipple/breast milk/baby predicted incidence of the case definition (rate ratio (RR) 1.87 (95% CI 1.10 to 3.16, p=0.018). We do not have evidence that S aureus colonisation was a predictor of these symptoms (RR 1.53, 95% CI 0.88 to 2.64, p=0.13). Nipple damage was also a predictor of these symptoms, RR 2.30 (95% CI 1.19 to 4.43, p=0.012). In the multivariate model, with all three predictors, the RRs were very similar to the univariate RRs. This indicates that Candida and nipple damage are independent predictors of our case definition.
PMCID: PMC3612759  PMID: 23474794
Primary Care
7.  The ProPrems trial: investigating the effects of probiotics on late onset sepsis in very preterm infants 
BMC Infectious Diseases  2011;11:210.
Late onset sepsis is a frequent complication of prematurity associated with increased mortality and morbidity. The commensal bacteria of the gastrointestinal tract play a key role in the development of healthy immune responses. Healthy term infants acquire these commensal organisms rapidly after birth. However, colonisation in preterm infants is adversely affected by delivery mode, antibiotic treatment and the intensive care environment. Altered microbiota composition may lead to increased colonisation with pathogenic bacteria, poor immune development and susceptibility to sepsis in the preterm infant.
Probiotics are live microorganisms, which when administered in adequate amounts confer health benefits on the host. Amongst numerous bacteriocidal and nutritional roles, they may also favourably modulate host immune responses in local and remote tissues. Meta-analyses of probiotic supplementation in preterm infants report a reduction in mortality and necrotising enterocolitis. Studies with sepsis as an outcome have reported mixed results to date.
Allergic diseases are increasing in incidence in "westernised" countries. There is evidence that probiotics may reduce the incidence of these diseases by altering the intestinal microbiota to influence immune function.
This is a multi-centre, randomised, double blinded, placebo controlled trial investigating supplementing preterm infants born at < 32 weeks' gestation weighing < 1500 g, with a probiotic combination (Bifidobacterium infantis, Streptococcus thermophilus and Bifidobacterium lactis). A total of 1,100 subjects are being recruited in Australia and New Zealand. Infants commence the allocated intervention from soon after the start of feeds until discharge home or term corrected age. The primary outcome is the incidence of at least one episode of definite (blood culture positive) late onset sepsis before 40 weeks corrected age or discharge home. Secondary outcomes include: Necrotising enterocolitis, mortality, antibiotic usage, time to establish full enteral feeds, duration of hospital stay, growth measurements at 6 and 12 months' corrected age and evidence of atopic conditions at 12 months' corrected age.
Results from previous studies on the use of probiotics to prevent diseases in preterm infants are promising. However, a large clinical trial is required to address outstanding issues regarding safety and efficacy in this vulnerable population. This study will address these important issues.
Trial registration
Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN012607000144415
The product "ABC Dophilus Probiotic Powder for Infants®", Solgar, USA has its 3 probiotics strains registered with the Deutsche Sammlung von Mikroorganismen und Zellkulturen (DSMZ - German Collection of Microorganisms and Cell Cultures) as BB-12 15954, B-02 96579, Th-4 15957.
PMCID: PMC3199779  PMID: 21816056
8.  The role of micro-organisms (Staphylococcus aureus and Candida albicans) in the pathogenesis of breast pain and infection in lactating women: study protocol 
The CASTLE (Candida and Staphylococcus Transmission: Longitudinal Evaluation) study will investigate the micro-organisms involved in the development of mastitis and "breast thrush" among breastfeeding women. To date, the organism(s) associated with the development of breast thrush have not been identified. The CASTLE study will also investigate the impact of physical health problems and breastfeeding problems on maternal psychological health in the early postpartum period.
The CASTLE study is a longitudinal descriptive study designed to investigate the role of Staphylococcus spp (species) and Candida spp in breast pain and infection among lactating women, and to describe the transmission dynamics of S. aureus and Candida spp between mother and infant. The relationship between breastfeeding and postpartum health problems as well as maternal psychological well-being is also being investigated. A prospective cohort of four hundred nulliparous women who are at least thirty six weeks gestation pregnant are being recruited from two hospitals in Melbourne, Australia (November 2009 to June 2011). At recruitment, nasal, nipple (both breasts) and vaginal swabs are taken and participants complete a questionnaire asking about previous known staphylococcal and candidal infections. Following the birth, participants are followed-up six times: in hospital and then at home weekly until four weeks postpartum. Participants complete a questionnaire at each time points to collect information about breastfeeding problems and postpartum health problems. Nasal and nipple swabs and breast milk samples are collected from the mother. Oral and nasal swabs are collected from the baby. A telephone interview is conducted at eight weeks postpartum to collect information about postpartum health problems and breastfeeding problems, such as mastitis and nipple and breast pain.
This study is the first longitudinal study of the role of both staphylococcal and candidal colonisation in breast infections and will help to resolve the current controversy about which is the primary organism in the condition known as breast thrush. This study will also document transmission dynamics of S. aureus and Candida spp between mother and infant. In addition, CASTLE will investigate the impact of common maternal physical health symptoms and the effect of breastfeeding problems on maternal psychological well-being.
PMCID: PMC3151214  PMID: 21777483
9.  A prospective randomised trial comparing nasogastric with intravenous hydration in children with bronchiolitis (protocol) The comparative rehydration in bronchiolitis study (CRIB) 
BMC Pediatrics  2010;10:37.
Bronchiolitis is the most common reason for admission of infants to hospital in developed countries. Fluid replacement therapy is required in about 30% of children admitted with bronchiolitis. There are currently two techniques of fluid replacement therapy that are used with the same frequency-intravenous (IV) or nasogastric (NG).
The evidence to determine the optimum route of hydration therapy for infants with bronchiolitis is inadequate. This randomised trial will be the first to provide good quality evidence of whether nasogastric rehydration (NGR) offers benefits over intravenous rehydration (IVR) using the clinically relevant continuous outcome measure of duration of hospital admission.
A prospective randomised multi-centre trial in Australia and New Zealand where children between 2 and 12 months of age with bronchiolitis, needing non oral fluid replacement, are randomised to receive either intravenous (IV) or nasogastric (NG) rehydration.
750 patients admitted to participating hospitals will be recruited, and will be followed daily during the admission and by telephone 1 week after discharge. Patients with chronic respiratory, cardiac, or neurological disease; choanal atresia; needing IV fluid resuscitation; needing an IV for other reasons, and those requiring CPAP or ventilation are excluded.
The primary endpoint is duration of hospital admission. Secondary outcomes are complications, need for ICU admission, parental satisfaction, and an economic evaluation. Results will be analysed using t-test for continuous data, and chi squared for categorical data. Non parametric data will be log transformed.
This trial will define the role of NGR and IVR in bronchiolitis
Trail registration
The trial is registered with the Australian and New Zealand Clinical Trials Registry - ACTRN12605000033640
PMCID: PMC2903564  PMID: 20515467
10.  Optimizing Postprandial Glycemia in Pediatric Patients With Type 1 Diabetes Using Insulin Pump Therapy 
Diabetes Care  2008;31(8):1491-1495.
OBJECTIVE—Postprandial glycemic excursions may contribute to the development of diabetes-related complications. Meals of high and low glycemic index (GI) have distinct effects on postprandial glycemia (PPG). Insulin pump therapy offers the potential to tailor insulin delivery to meal composition; however, optimal bolus types for meals of different glycemic loads have not been defined. We sought to compare the impact of GI combined with varying prandial bolus types on PPG.
RESEARCH DESIGN AND METHODS—An open crossover study examining the effects of four different meal and bolus-type combinations on 3-h PPG (measured by continuous glucose-monitoring system [CGMS]) was conducted. A total of 20 young people aged 8–18 years with type 1 diabetes using insulin-pump therapy participated. Meals had equal macronutrient, energy, and fiber content and differed only in GI (low vs. high). Participants consumed meals of the same GI on consecutive days and were randomized to receive either a standard (100%) or a dual-wave (DW) (50:50% over 2 h) bolus each day. CGMS data from 10 healthy control participants established the target response to each meal.
RESULTS—A DW bolus before low-GI meals decreased PPG area under the curve (AUC) by up to 47% (P = 0.004) and lowered the risk of hypoglycemia for the same premeal glucose (P = 0.005) compared with standard bolus. High-GI meals resulted in significant upward PPG excursions with greater AUC (P = 0.45), regardless of bolus type.
CONCLUSIONS—These data support the use of a DW bolus with low GI meals to optimize PPG in patients with type 1 diabetes using insulin pump therapy.
PMCID: PMC2494638  PMID: 18509207
11.  Nurses' perceived barriers to the implementation of a Fall Prevention Clinical Practice Guideline in Singapore hospitals 
Theories of behavior change indicate that an analysis of barriers to change is helpful when trying to influence professional practice. The aim of this study was to assess the perceived barriers to practice change by eliciting nurses' opinions with regard to barriers to, and facilitators of, implementation of a Fall Prevention clinical practice guideline in five acute care hospitals in Singapore.
Nurses were surveyed to identify their perceptions regarding barriers to implementation of clinical practice guidelines in their practice setting. The validated questionnaire, 'Barriers and facilitators assessment instrument', was administered to nurses (n = 1830) working in the medical, surgical, geriatric units, at five acute care hospitals in Singapore.
An 80.2% response rate was achieved. The greatest barriers to implementation of clinical practice guidelines reported included: knowledge and motivation, availability of support staff, access to facilities, health status of patients, and, education of staff and patients.
Numerous barriers to the use of the Fall Prevention Clinical Practice Guideline have been identified. This study has laid the foundation for further research into implementation of clinical practice guidelines in Singapore by identifying barriers to change in acute care settings.
PMCID: PMC2422837  PMID: 18485235
12.  A systematic review of maternal obesity and breastfeeding intention, initiation and duration 
Breastfeeding behaviour is multifactorial, and a wide range of socio-cultural and physiological variables impact on a woman's decision and ability to breastfeed successfully. An association has been reported between maternal obesity and low breastfeeding rates. This is of public health concern because obesity is rising in women of reproductive age and the apparent association with increased artificial feeding will lead to a greater risk of obesity in children. The aim of this paper is to examine the relationship between maternal overweight and obesity and breastfeeding intention and initiation and duration.
A systematic review was conducted in January and February 2007, using the following databases: Medline, CINAHL and the Australian Breastfeeding Association's Lactation Resource Centre. Studies which have examined maternal obesity and infant feeding intention, initiation, duration and delayed onset of lactation were tabulated and summarised.
Studies have found that obese women plan to breastfeed for a shorter period than normal weight women and are less likely to initiate breastfeeding. Of the four studies that examined onset of lactation, three reported a significant relationship between obesity and delayed lactogenesis. Fifteen studies, conducted in the USA, Australia, Denmark, Kuwait and Russia, have examined maternal obesity and duration of breastfeeding. The majority of large studies found that obese women breastfed for a shorter duration than normal weight women, even after adjusting for possible confounding factors.
There is evidence from epidemiological studies that overweight and obese women are less likely to breastfeed than normal weight women. The reasons may be biological or they may be psychological, behavioral and/or cultural. We urgently need qualitative studies from women's perspective to help us understand women in this situation and their infant feeding decisions and behaviour.
PMCID: PMC1937008  PMID: 17608952
13.  Puberty and the Onset of Substance Use and Abuse 
Pediatrics  2004;114(3):e300-e306.
Substance abuse remains one of the major threats to adolescent health in Western cultures. The study aim was to ascertain the extent of association between pubertal development and early adolescent substance use.
The design was a cross-sectional survey of 10- to 15-year-old subjects in the states of Washington, United States, and Victoria, Australia. Participants were 5769 students in grades 5, 7, and 9, drawn as a 2-stage cluster sample in each state, and the questionnaire was completed in the school classrooms. The main outcomes of the study were lifetime substance use (tobacco use, having been drunk, or cannabis use), recent substance use (tobacco, alcohol, or cannabis use in the previous month), and substance abuse (daily smoking, any binge drinking, drinking at least weekly, or cannabis use at least weekly).
The odds of lifetime substance use were almost twofold higher (odds ratio [OR]: 1.7; 95% confidence interval [CI]: 1.4-2.1) in midpuberty (Tanner stage III) and were threefold higher (OR: 3.1; 95% CI: 2.4-4.2) in late puberty (Tanner stage IV/V), after adjustment for age and school grade level. Recent substance use was moderately higher (OR: 1.4; 95% CI: 1.0-1.9) in midpuberty and more than twofold higher (OR: 2.3; 95% CI: 1.7-3.3) in late puberty. The odds of substance abuse were twofold higher (OR: 2.0; 95% CI: 1.2-3.2) in midpuberty and more than threefold higher (OR: 3.5; 95% CI: 2.2-5.4) in late puberty. Reporting most friends as substance users was more likely in the later stages of pubertal development, a relationship that accounted in part for the association found between later pubertal stage and substance abuse.
Pubertal stage was associated with higher rates of substance use and abuse independent of age and school grade level. Early maturers had higher levels of substance use because they entered the risk period at an earlier point than did late maturers. The study findings support prevention strategies and policies that decrease recreational substance use within the peer social group in the early teens.
PMCID: PMC1892192  PMID: 15342890
puberty; substance abuse; smoking; alcohol consumption; cannabis; adolescence
14.  Reliability of the Hazelbaker Assessment Tool for Lingual Frenulum Function 
About 3% of infants are born with a tongue-tie which may lead to breastfeeding problems such as ineffective latch, painful attachment or poor weight gain. The Hazelbaker Assessment Tool for Lingual Frenulum Function (HATLFF) has been developed to give a quantitative assessment of the tongue-tie and recommendation about frenotomy (release of the frenulum). The aim of this study was to assess the inter-rater reliability of the HATLFF.
Fifty-eight infants referred to the Breastfeeding Education and Support Services (BESS) at The Royal Women's Hospital for assessment of tongue-tie and 25 control infants were assessed by two clinicians independently.
The Appearance items received kappas between about 0.4 to 0.6, which represents "moderate" reliability. The first three Function items (lateralization, lift and extension of tongue) had kappa values over 0.65 which indicates "substantial" agreement. The four Function items relating to infant sucking (spread, cupping, peristalsis and snapback) received low kappa values with insignificant p values. There was 96% agreement between the two assessors on the recommendation for frenotomy (kappa 0.92, excellent agreement). The study found that the Function Score can be more simply assessed using only the first three function items (ie not scoring the sucking items), with a cut-off of ≤4 for recommendation of frenotomy.
We found that the HATLFF has a high reliability in a study of infants with tongue-tie and control infants
PMCID: PMC1464379  PMID: 16722609

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