Frenotomy with breastfeeding support versus breastfeeding support alone for infants with tongue-tie and breastfeeding difficulties: the FROSTTIE RCT

BackgroundTongue-tie can be diagnosed in 3–11% of babies, with some studies reporting almost universal breastfeeding difficulties, and others reporting very few feeding difficulties that relate to the tongue-tie itself, instead noting that incorrect positioning and attachment are the primary reasons behind the observed breastfeeding difficulties and not the tongue-tie itself. The only existing trials of frenotomy are small and underpowered and/or include only very short-term or subjective outcomes.ObjectiveTo investigate whether frenotomy is clinically and cost-effective to promote continuation of breastfeeding at 3 months in infants with breastfeeding difficulties diagnosed with tongue-tie.DesignA multicentre, unblinded, randomised, parallel group controlled trial.SettingTwelve infant feeding services in the UK.ParticipantsInfants aged up to 10 weeks referred to an infant feeding service (by a parent, midwife or other breastfeeding support service) with breastfeeding difficulties and judged to have tongue-tie.InterventionsInfants were randomly allocated to frenotomy with standard breastfeeding support or standard breastfeeding support without frenotomy.Main outcome measuresPrimary outcome was any breastmilk feeding at 3 months according to maternal self-report. Secondary outcomes included mother’s pain, exclusive breastmilk feeding, exclusive direct breastfeeding, frenotomy, adverse events, maternal anxiety and depression, maternal and infant NHS health-care resource use, cost-effectiveness, and any breastmilk feeding at 6 months of age.ResultsBetween March 2019 and November 2020, 169 infants were randomised, 80 to the frenotomy with breastfeeding support arm and 89 to the breastfeeding support arm from a planned sample size of 870 infants. The trial was stopped in the context of the COVID-19 pandemic due to withdrawal of breastfeeding support services, slow recruitment and crossover between arms. In the frenotomy with breastfeeding support arm 74/80 infants (93%) received their allocated intervention, compared to 23/89 (26%) in the breastfeeding support arm. Primary outcome data were available for 163/169 infants (96%). There was no evidence of a difference between the arms in the rate of breastmilk feeding at 3 months, which was high in both groups (67/76, 88% vs. 75/87, 86%; adjusted risk ratio 1.02, 95% confidence interval 0.90 to 1.16). Adverse events were reported for three infants after surgery [bleeding (n = 1), salivary duct damage (n = 1), accidental cut to the tongue and salivary duct damage (n = 1)]. Cost-effectiveness could not be determined with the information available.LimitationsThe statistical power of the analysis was extremely limited due to not achieving the target sample size and the high proportion of infants in the breastfeeding support arm who underwent frenotomy.ConclusionsThis trial does not provide sufficient information to assess whether frenotomy in addition to breastfeeding support improves breastfeeding rates in infants diagnosed with tongue-tie.Future workThere is a clear lack of equipoise in the UK concerning the use of frenotomy, however, the effectiveness and cost-effectiveness of the procedure still need to be established. Other study designs will need to be considered to address this objective.Trial registrationThis trial is registered as ISRCTN 10268851

Palliative Care and Health Care Utilization for Patients With End-Stage Liver Disease at the End of Life

Background & aimsThere has been increased attention on ways to improve the quality of end-of-life care for patients with end-stage liver disease; however, there have been few reports of care experiences for patients during terminal hospitalizations. We analyzed data from a large national database to increase our understanding of palliative care for and health care utilization by patients with end-stage liver disease.MethodsWe performed a cross-sectional, observational study to examine terminal hospitalizations of adults with decompensated cirrhosis using data from the National Inpatient Sample from 2009 through 2013. We collected data on palliative care consultation and total hospital costs, and performed multivariate regression analyses to identify factors associated with palliative care consultation. We also investigated whether consultation was associated with lower costs.ResultsAmong hospitalized adults with terminal decompensated cirrhosis, 30.3% received palliative care; the mean cost per hospitalization was $48,551 ±$1142. Palliative care consultation increased annually, and was provided to 18.0% of patients in 2009 and to 36.6% of patients in 2013 (P < .05). The mean cost for the terminal hospitalization did not increase significantly ($47,969 in 2009 to$48,956 in 2013, P = .77). African Americans, Hispanics, Asians, and liver transplant candidates were less likely to receive palliative care, whereas care in large urban teaching hospitals was associated with a higher odds of receiving consultation. Palliative care was associated with lower procedure burden-after adjusting for other factors, palliative care was associated with a cost reduction of $10,062.ConclusionsPalliative care consultation for patients with end-stage liver disease increased from 2009 through 2013. Palliative care consultation during terminal hospitalizations is associated with lower costs and procedure burden. Future research should evaluate timing and effects of palliative care on quality of end-of-life care in this population

Benefits and harms adopted by health economic assessments evaluating antenatal and newborn screening programmes in OECD countries: A systematic review of 336 articles and reports.

BACKGROUND: Health economic assessments are used to determine whether the resources needed to generate net benefit from a screening programme, driven by multiple complex benefits and harms, are justifiable. We systematically identified the benefits and harms incorporated within economic assessments evaluating antenatal and newborn screening programmes. METHODS: For this systematic review and thematic analysis, we searched the published and grey literature from January 2000 to January 2021. Studies that included an economic evaluation of an antenatal or newborn screening programme in an OECD country were eligible. We identified benefits and harms using an integrative descriptive analysis, and illustrated a thematic framework. (Systematic review registration PROSPERO, CRD42020165236). FINDINGS: The searches identified 52,244 articles and reports and 336 (242 antenatal and 95 newborn) were included. Eighty-six subthemes grouped into seven themes were identified: 1) diagnosis of screened for condition, 2) life years and health status adjustments, 3) treatment, 4) long-term costs, 5) overdiagnosis, 6) pregnancy loss, and 7) spillover effects on family members. Diagnosis of screened for condition (115 studies, 47.5%), life-years and health status adjustments (90 studies, 37.2%) and treatment (88 studies, 36.4%) accounted for most of the benefits and harms evaluating antenatal screening. The same themes accounted for most of the benefits and harms included in studies assessing newborn screening. Overdiagnosis and spillover effects tended to be ignored. INTERPRETATION: Our proposed framework can be used to guide the development of future health economic assessments evaluating antenatal and newborn screening programmes, to prevent exclusion of important potential benefits and harms

Group B streptococcal disease in infants aged younger than 3 months: systematic review and meta-analysis.

BACKGROUND: Despite widespread use of intrapartum antibiotic prophylaxis, group B streptococcus remains a leading cause of morbidity and mortality in infants in Europe, the Americas, and Australia. However, estimates of disease burden in many countries outside of these regions is not available. We aimed to examine the current global burden of invasive disease and the serotype distribution of group B streptococcus isolates. METHODS: We searched Medline, Embase, and Wholis databases for studies on invasive early-onset (day 0-6) and late-onset (day 7-89) group B streptococcal disease. Eligible studies were those that described incidence, deaths, or serotypes. We also reviewed reference lists and contacted experts to seek unpublished data and data missed by our search. Random effects meta-analysis was used to pool data. FINDINGS: 74 studies met the inclusion criteria; 56 studies reported incidence, 29 case fatality, and 19 serotype distribution. An additional search for studies that reported serotype distribution from Jan 1, 1980, yielded a total of 38 articles. Only five low-income countries were represented in the review and contributed 5% weight to the meta-analysis. 47 (69%) studies reported use of any intrapartum antibiotic prophylaxis. Substantial heterogeneity existed between studies. Mean incidence of group B streptococcus in infants aged 0-89 days was 0·53 per 1000 livebirths (95% CI 0·44-0·62) and the mean case fatality ratio was 9·6% (95% CI 7·5-11·8). Incidence of early-onset group B streptococcus (0·43 per 1000 livebirths [95% CI 0·37-0·49]) and case fatality (12·1%, [6·2-18·3]) were two-times higher than late-onset disease. Serotype III (48·9%) was the most frequently identified serotype in all regions with available data followed by serotypes Ia (22·9%), Ib (7·0%), II (6·2%), and V (9·1%). Studies that reported use of any intrapartum antibiotic prophylaxis were associated with lower incidence of early-onset group B streptococcus (0·23 per 1000 livebirths [95% CI 0·13-0·59]) than studies in which patients did not use prophylaxis (0·75 per 1000 livebirths [0·58-0·89]). INTERPRETATION: More high-quality studies are needed to accurately estimate the global burden of group B streptococcus, especially in low-income countries. A conjugate vaccine incorporating five serotypes (Ia, Ib, II, III, V) could prevent most global group B streptococcal disease. FUNDING: Child Epidemiology Reference Group (CHERG), WHO

Thigh-length compression stockings and DVT after stroke

Controversy exists as to whether neoadjuvant chemotherapy improves survival in patients with invasive bladder cancer, despite randomised controlled trials of more than 3000 patients. We undertook a systematic review and meta-analysis to assess the effect of such treatment on survival in patients with this disease

Palliative Care and Health Care Utilization for Patients With End-Stage Liver Disease at the End of Life

Background & aimsThere has been increased attention on ways to improve the quality of end-of-life care for patients with end-stage liver disease; however, there have been few reports of care experiences for patients during terminal hospitalizations. We analyzed data from a large national database to increase our understanding of palliative care for and health care utilization by patients with end-stage liver disease.MethodsWe performed a cross-sectional, observational study to examine terminal hospitalizations of adults with decompensated cirrhosis using data from the National Inpatient Sample from 2009 through 2013. We collected data on palliative care consultation and total hospital costs, and performed multivariate regression analyses to identify factors associated with palliative care consultation. We also investigated whether consultation was associated with lower costs.ResultsAmong hospitalized adults with terminal decompensated cirrhosis, 30.3% received palliative care; the mean cost per hospitalization was $48,551 ±$1142. Palliative care consultation increased annually, and was provided to 18.0% of patients in 2009 and to 36.6% of patients in 2013 (P < .05). The mean cost for the terminal hospitalization did not increase significantly ($47,969 in 2009 to$48,956 in 2013, P = .77). African Americans, Hispanics, Asians, and liver transplant candidates were less likely to receive palliative care, whereas care in large urban teaching hospitals was associated with a higher odds of receiving consultation. Palliative care was associated with lower procedure burden-after adjusting for other factors, palliative care was associated with a cost reduction of $10,062.ConclusionsPalliative care consultation for patients with end-stage liver disease increased from 2009 through 2013. Palliative care consultation during terminal hospitalizations is associated with lower costs and procedure burden. Future research should evaluate timing and effects of palliative care on quality of end-of-life care in this population