Gestational breast cancer in New South Wales: A population-based linkage study of incidence, management, and outcomes.

BACKGROUND: The incidence of gestational breast cancer (GBC) is increasing in high-income countries. Our study aimed to examine the epidemiology, management and outcomes of women with GBC in New South Wales (NSW), Australia. METHODS: A retrospective cohort study using linked data from three NSW datasets. The study group comprised women giving birth with a first-time diagnosis of GBC while the comparison group comprised women giving birth without any type of cancer. Outcome measures included incidence of GBC, maternal morbidities, obstetric management, neonatal mortality, and preterm birth. RESULTS: Between 1994 and 2013, 122 women with GBC gave birth in NSW (crude incidence 6.8/ 100,000, 95%CI: 5.6-8.0). Women aged ≥35 years had higher odds of GBC (adjusted odds ratio (AOR) 6.09, 95%CI 4.02-9.2) than younger women. Women with GBC were more likely to give birth by labour induction or pre-labour CS compared to women with no cancer (AOR 4.8, 95%CI: 2.96-7.79). Among women who gave birth by labour induction or pre-labour CS, the preterm birth rate was higher for women with GBC than for women with no cancer (52% vs 7%; AOR 17.5, 95%CI: 11.3-27.3). However, among women with GBC, preterm birth rate did not differ significantly by timing of diagnosis or cancer stage. Babies born to women with GBC were more likely to be preterm (AOR 12.93, 95%CI 8.97-18.64), low birthweight (AOR 8.88, 95%CI 5.87-13.43) or admitted to higher care (AOR 3.99, 95%CI 2.76-5.76) than babies born to women with no cancer. CONCLUSION: Women aged ≥35 years are at increased risk of GBC. There is a high rate of preterm birth among women with GBC, which is not associated with timing of diagnosis or cancer stage. Most births followed induction of labour or pre-labour CS, with no major short term neonatal morbidity.

Effectiveness of social egg freezing: protocol for systematic review and meta-analyses.

INTRODUCTION: Social egg freezing is storing egg for the purpose of preserving fertility and delayed childbearing. Currently, little is known about the utilisation and effectiveness of this approach. This review aims to determine (1) the proportion of women who used their stored eggs, and (2) the egg survival rate through vitrification, and the clinical pregnancy rate and live birth rate per 100 women partaking in the procedure, and among women who stored their eggs for medical reasons. METHODS AND ANALYSES: This systematic review will be done according to the items listed in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. PubMed, Embase, Scopus, The Cumulative Index to Nursing and Allied Health Literature (CINAHL) and the Cochrane Library and Health Technology Assessment databases will be searched to identify eligible studies published since 2012. Two reviewers will independently appraise the eligibility and quality of the studies based on preset checklists and extract the data using a data extraction template. Outcomes of interest are proportion of women who used their stored eggs, egg survival rate, pregnancy rate and live birth rates. We will determine the presence heterogeneity among studies using the Cochrane's Q test. The percentage of total variation across studies, which is due to statistical heterogeneity, will be calculated using the I2 statistics. Outcomes of interest will be pooled together using metaprop programme STATA V.14. ETHICS AND DISSEMINATION: For this review, ethical committee approval is not required. We will use publically available data from previously published studies. The final report of the review will be disseminated through publication on national or international journal, and it will be presented on different scientific conferences. PROSPERO REGISTRATION NUMBER: CRD42018114254.

Are health facilities well equipped to provide basic quality childbirth services under the free maternal health policy? Findings from rural Northern Ghana.

BACKGROUND: Basic inputs and infrastructure including drugs, supplies, equipment, water and electricity are required for the provision of quality care. In the era of the free maternal health policy in Ghana, it is unclear if such basic inputs are readily accessible in health facilities. The study aimed to assess the availability of basic inputs including drugs, supplies, equipment and emergency transport in health facilities. Women and health providers' views on privacy and satisfaction with quality of care were also assessed. METHODS: The study used a convergent parallel mixed methods in one rural municipality in Ghana, Kassena-Nankana. A survey among facilities (n = 14) was done. Another survey was carried out among women who gave birth in health facilities only (n = 353). A qualitative component involved focus group discussions (FGDs) with women (n = 10) and in-depth interviews (IDIs) with midwives and nurses (n = 25). Data were analysed using descriptive statistics for the quantitative study, while the qualitative data were recorded, transcribed, read and coded using themes. RESULTS: The survey showed that only two (14%) out of fourteen facilities had clean water, and five (36%) had electricity. Emergency transport for referrals was available in only one (7%) facility. Basic drugs, supplies, equipment and infrastructure especially physical space were inadequate. Rooms used for childbirth in some facilities were small and used for multiple purposes. Eighty-nine percent (n = 314) of women reported lack of privacy during childbirth and this was confirmed in the IDIs. Despite this, 77% of women (n = 272) were very satisfied or satisfied with quality of care for childbirth which was supported in the FGDs. Reasons for women's satisfaction included the availability of midwives to provide childbirth services and to have follow-up homes visits. Some midwives were seen to be patient and empathetic. Providers were not satisfied due to health system challenges. CONCLUSION: Government should dedicate more resources to the provision of essential inputs for CHPS compounds providing maternal health services. Health management committees should also endeavour to play an active role in the management of health facilities to ensure efficiency and accountability. These would improve quality service provision and usage, helping to achieve universal health coverage.

Government Patent Use to Address the Rising Cost of Naloxone: 28 U.S.C. § 1498 and Evzio.

The rising cost of the opioid antagonist and overdose reversal agent naloxone is an urgent public health problem. The recent and dramatic price increase of Evzio, a naloxone auto-injector produced by Kaléo, shows how pharmaceutical manufacturers entering the naloxone marketplace rely on market exclusivity guaranteed by the patent system to charge prices at what the market can bear, which can restrict access to life-saving medication. We argue that 28 U.S.C. § 1498, a section of the federal code that allows the government to use patent-protected products for its own purposes in exchange for reasonable compensation, could be used to procure generic naloxone auto-injectors, or at least bring Kaléo to the negotiating table. Precedent exists for the use of § 1498 to procure pharmaceuticals, and it could give meaning to the federal government's recent declaration of a public health emergency around the opioid epidemic, discourage new market entrants from charging exorbitant prices, and yield important public health benefits.

The implementation of the free maternal health policy in rural Northern Ghana: synthesised results and lessons learnt.

OBJECTIVE: A free maternal health policy was implemented under Ghana's National Health Insurance Scheme to promote the use of maternal health services. Under the policy, women are entitled to free services throughout pregnancy and at childbirth. A mixed methods study involving women, providers and insurance managers was carried out in the Kassena-Nankana municipality of Ghana. It explored the affordability, availability, acceptability and quality of services. In this manuscript, we present synthesised results categorised as facilitators and barriers to access as well as lessons learnt (implications). RESULTS: Reasonable waiting times, cleanliness of facilities as well as good interpersonal relationships with providers were the facilitators to access. Barriers included out of pocket payments, lack of, or inadequate supply of drugs and commodities, equipment, water, electricity and emergency transport. Four lessons (implications) were identified. Firstly, out of pocket payments persisted. Secondly, the health system was not strengthened before implementing the free maternal health policy. Thirdly, lower level facilities were poorly resourced. Finally, the lack of essential inputs and infrastructure affected quality of care and therefore, access to care. It is suggested that the Government of Ghana, the Health Insurance Scheme and other stakeholders improve the provision of resources to facilities.

Has the free maternal health policy eliminated out of pocket payments for maternal health services? Views of women, health providers and insurance managers in Northern Ghana.

INTRODUCTION: The free maternal health policy was implemented in Ghana in 2008 under the National Health Insurance Scheme (NHIS). The policy sought to eliminate out of pocket (OOP) payments and enhance the utilisation of maternal health services. It is unclear whether the policy had altered OOP payments for services. The study explored views on costs and actual OOP payments during pregnancy. The source of funding for payments was also explored. METHODS: A convergent parallel mixed methods design, involving quantitative and qualitative data collection approaches. The study was set in the Kassena-Nankana municipality, a rural area in Ghana. Women (n = 406) who utilised services during pregnancy were surveyed. Also, 10 focus groups discussions (FGDs) were held with women who used services during pregnancy as well as 28 in-depth interviews (IDIs) with midwives/nurses (n = 25) and insurance managers/directors (n = 3). The survey was analysed using descriptive statistics, focussing on costs from the women's perspective. Qualitative data were audio recorded, transcribed and translated verbatim into English where necessary. The transcripts were read and coded into themes and sub-themes. RESULTS: The NHIS did not cover all expenses in relation to maternal health services. The overall mean for OOP cost during pregnancy was GH¢17.50 (US$8.60). Both FGDs and IDIs showed that women especially paid for drugs and ultrasound scan services. Sixty-five percent of the women used savings, whilst twenty-two percent sold assets to meet the OOP cost. Some women were unable to afford payments due to poverty and had to forgo treatment. Participants called for payments to be eliminated and for the NHIS to absorb the cost of emergency referrals. All participants admitted the benefits of the policy. CONCLUSION: Women needed to make payments despite the policy. Measures should be put in place to eliminate payments to enable all women to receive services and promote universal health coverage.

Assessment of early occlusal caries pre- and post-sealant application--an imaging approach.

BACKGROUND AND OBJECTIVE: Clinicians have difficulty assessing and monitoring early occlusal caries. Traditional clinical exam and radiographs are unable to detect the subtle alterations in enamel indicative of de- or re-mineralization, particularly under dental sealants. Although clinicians have used laser fluorescence (LF) to address this gap, this modality has demonstrated weak correlation with histology. The International Caries Detection and Assessment System (ICDAS-II) has demonstrated high sensitivity and specificity for caries detection, but since it is based on visual assessment, it is of no use in areas beneath the most commonly used dental sealants which are opaque. Optical coherence tomography (OCT) is an emergent assessment tool which has demonstrated great promise in detecting and quantifying caries, including areas beneath commonly used dental sealants and composites. However, OCT has not yet been widely integrated into clinical dental practice, perhaps because OCT imaging does not provide an easily accessible diagnostic outcome for clinicians. The objective of this ex vivo study was to use OCT-images of sound and carious occlusal surfaces in combination with a simple algorithm to compare the caries detection ability of OCT with tools clinicians may be more familiar with (LF and radiography), and with an established valid and reliable clinical assessment tool (ICDAS-II). STUDY DESIGN/MATERIALS AND METHODS: One hundred twenty extracted teeth with sound or naturally carious occlusal surfaces were imaged with OCT, LF, radiography, and examined clinically with the ICDAS-II. Teeth were randomized to one of two dental sealants recommended for use with LF. A novel simple algorithm was used to interpret OCT-based images. The accuracy of caries severity assessments of the OCT-based diagnosis, LF, ICDAS-II, and digital radiography were compared to the 4-point histological analysis gold standard. RESULTS: OCT and ICDAS-II caries severity assessments demonstrated high sensitivity (94.0%; 92.3%) and specificity (85.0%; 83.3%), LF demonstrated low sensitivity (65.2%) but high specificity (97.6%), and digital radiography demonstrated low sensitivity (67.1%) with moderate specificity (79.5%) on unsealed occlusal surfaces. OCT-based caries severity assessments of sealed teeth demonstrated high specificity (97.6%), sensitivity (89.9%), excellent positive predictive value (98.6%), and negative predictive value (83.3%). Despite our use of LF recommended dental sealants, in the presence of sealants, LF assessment of caries severity demonstrated high sensitivity (95.1%), but extremely low specificity (10.3%), positive predictive value (68.8%), and negative predictive value (50.0%). CONCLUSION: This study found that OCT-based imaging combined with a simple diagnostic algorithm accurately assessed the severity of natural early caries on occlusal surfaces in extracted teeth both in the absence and presence of dental sealant. The findings of this study support the clinical use of OCT imaging for assessment and monitoring progression of early non-cavitated caries lesions on occlusal surfaces including areas under dental sealants.