Provision of medical abortion using telemedicine in Brazil

Objective

To evaluate the need for and outcome of self-administered medical abortion with mifepristone and misoprostol in Brazil, provided through Women on Web, a global telemedicine abortion service.

Study Design

A retrospective case review of women from Brazil who contacted Women on Web in 2011. Information from the online consultation, follow-up questionnaire and emails were used to analyze data including demographics, gestational age, outcome of the medical abortion and symptoms that lead to surgical interventions.

Results

The Women on Web website had 109779 unique visitors from Brazil, 2104 women contacted the helpdesk by email. Of the 1401 women who completed the online consultation, 602 women continued their request for a medical abortion. Of the 370 women who used the medicines, 307 women gave follow-up information about the outcome of the medical abortion. Of these, 207 (67.4%) women were 9 weeks or less pregnant, 71 (23.1%) were 10, 11 or 12 weeks pregnant, and 29 (9.5%) women were 13 weeks or more pregnant. There was a significant difference in surgical intervention rates after the medical abortion (19.3% at < 9 weeks, 15.5% at 11–12 weeks and 44.8% at > 13 weeks, p=.06). However, 42.2% of the women who had a surgical intervention had no symptoms of a complication.

Conclusion

There is large need for medical abortion in Brazil. Home use of mifepristone and misoprostol provided through telemedicine is safe and effective. However, after 13 weeks gestation, there is an increased risk of surgical intervention that may be due to the regimen used and local clinical practices in Brazil.

Implications

The current study shows that there is an unmet need for medical abortion in Brazil, a country with legal restrictions on access to safe abortion services. Telemedicine can help fulfill the need and self administration of medical abortion is safe and effective even at late first trimester abortion. Prospective trials are needed to establish safety, effectiveness and acceptability of home use of medical abortion beyond 12 weeks of pregnancy.     

Feminized Behavior and Brain Gene Expression in a Novel Mouse Model of Klinefelter Syndrome

Klinefelter Syndrome (KS) is the most common sex chromosome aneuploidy in men and is characterized by the presence of an additional X chromosome (XXY). In some Klinefelter males, certain traits may be feminized or shifted from the male-typical pattern towards a more female-typical one. Among them might be partner choice, one of the most sexually dimorphic traits in the animal kingdom. We investigated the extent of feminization in XXY male mice (XXYM) in partner preference and gene expression in the bed nucleus of the stria terminalis/preoptic area and the striatum in mice from the Sex Chromosome Trisomy model. We tested for partner preference using a three-chambered apparatus in which the test mouse was free to choose between stimulus animals of either sex. We found that partner preference in XXYM was feminized. These differences were likely due to interactions of the additional X chromosome with the Y. We also discovered genes that differed in expression in XXYM versus XYM. Some of these genes are feminized in their expression pattern. Lastly, we also identified genes that differed only between XXYM versus XYM and not XXM versus XYM. Genes that are both feminized and unique to XXYM versus XYM represent strong candidates for dissecting the molecular pathways responsible for phenotypes present in KS/XXYM but not XXM. In sum, our results demonstrated that investigating behavioral and molecular feminization in XXY males can provide crucial information about the pathophysiology of KS and may aid our understanding of sex differences in brain and behavior.     

Government Leadership in Addressing Public Health Priorities: Strides and Delays in Electronic Laboratory Reporting in the United States

For nearly a decade, interest groups, from politicians to economists to physicians, have touted digitization of the nation’s health information. One frequently mentioned benefit is the transmission of information electronically from laboratories to public health personnel, allowing them to rapidly analyze and act on these data.Switching from paper to electronic laboratory reports (ELRs) was thought to solve many public health surveillance issues, including workload, accuracy, and timeliness. However, barriers remain for both laboratories and public health agencies to realize the full benefits of ELRs.The New York City experience highlights several successes and challenges of electronic reporting and is supported by peer-reviewed literature. Lessons learned from ELR systems will benefit efforts to standardize electronic medical records reporting to health departments.LABORATORY REPORTS SUPPORT passive public health surveillance, providing highly specific data about health conditions in a community. Efficient electronic exchange of laboratory information can facilitate time-sensitive decision-making.1 This is particularly true for infectious diseases, which require timely, accurate data to confirm diagnoses, detect outbreaks, and prevent transmission of disease to additional people. As public health agencies expand their mission to address chronic diseases, such as diabetes, laboratory reporting will also have an important role. At present, electronic laboratory reports (ELRs) offer a more accurate, complete, and efficient data source for public health surveillance than do paper reports.2 Significant progress has been made in using ELRs, but challenges still exist for this public health reporting system.Since early in the 21st century, clinical laboratories have been transitioning from a system of mailing or faxing test results to exclusively transmitting data electronically to health departments. After September 11, 2001, Congress set up the Terrorism Preparedness and Emergency Response funds to support the public health emergency preparedness activities of the Centers for Disease Control and Prevention (CDC). This revenue initiated many state and local ELR systems, but funds have declined from $970 million in FY 2003 to $657 million in FY 2012.3 The National Electronic Disease Surveillance System coordinated by CDC provides standards and software and hardware resources to state and local health departments to implement standards-based ELR systems between clinics, health departments, and CDC. This national surveillance program has both accelerated ELR adoption, by providing standards, and delayed development, because of funding shortages and a lack of infrastructure support.4 In New York City, local public health legislation also facilitated ELR adoption.5 Improvements in technology, such as the incorporation of some messaging syntax standards into laboratory information management systems, have accelerated the shift to ELRs.2 In 2010, 42 US states reported having general communicable disease surveillance systems that incorporate ELRs,4 but how complete these systems are is unclear.Federal legislation such as the Health Information Technology for Economic and Clinical Health Act, part of the American Reinvestment and Recovery Act of 2009, further advanced the use of ELRs in health care facilities that employ electronic medical records (EMRs). This act created Meaningful Use (MU), a federal program with financial incentives to implement, upgrade, and demonstrate meaningful use of certified electronic health record technology. ELRs were included as part of the stage 1 MU incentives.4,6 MU, however, does not provide financial incentives for commercial clinical laboratories to make technology upgrades. A broader goal of the health information technology legislation and MU is for health care providers to eventually communicate with public health agencies electronically, rather than by paper or phone. For several reasons, EMR adoption has been a challenge.7 An efficient ELR surveillance system will be a valuable resource for public health, and the lessons learned from ELR implementation, such as the establishment of standards, will help inform the subsequent use of EMRs for public health surveillance.After reviewing the peer-reviewed literature addressing the topic of ELRs published between January 2000 and July 2012, we identified both substantial accomplishments and remaining challenges. The decision logic for the literature review and article inclusion is presented in Figure 1. To outline the issues, we studied the New York City Department of Health and Mental Hygiene (DOHMH) experience and followed the flow of a report from the clinical laboratory to the public health department. Along this cascade of information we identified major strides, delays, and possible solutions.Open in a separate windowFIGURE 1—Literature review inclusion decision tree for electronic laboratory reports in public health.Note. ELR = electronic laboratory report; LOINC = Logical Observation Identifiers Names and Codes. The term SNOMED was not included in the search criteria because it did not noticeably improve the results of the search over using the term LOINC alone.     

A cluster randomized non-inferiority field trial on the immunogenicity and safety of tetanus toxoid vaccine kept in controlled temperature chain compared to cold chain

Background

In resource-poor settings, cold chain requirements present barriers for vaccine delivery. We evaluated the immunogenicity and safety of tetanus toxoid (TT) vaccine in “Controlled Temperature Chain” (CTC; up to 40 °C for <30 days before administration), compared to standard cold chain (SCC; 2–8 °C). Prior to the study, stability parameters of TT–CTC were shown to meet international requirements.

Methods

A cluster randomized, non-inferiority trial was conducted in Moïssala district, Chad, December 2012–March 2013. Thirty-four included clusters were randomized to CTC or SCC. Women aged 14–49 years, eligible for TT vaccination and with a history of ≤1 TT dose, received two TT doses 4 weeks apart. Participants were blinded to allocation strategy. Tetanus antibody titers were measured using standard ELISA at inclusion and 4 weeks post-TT2. Primary outcome measures were post-vaccination seroconversion and fold-increase in geometric mean concentrations (GMC). Non-inferiority was by seroconversion difference (TT_SCC − TT_CTC) <5% and ratio of GMCs (TT_SCC/TT_CTC) <1.5. Adverse events were monitored at health centers and at next contact with participants.

Results

A total of 2128 women (CTC = 1068; SCC = 1060) were recruited. Primary intention to vaccinate analysis included 1830 participants; 272 of these were included in the seroconversion analysis. Seroconversion was reached by >95% of participants; upper 95%CI of the difference was 5.6%. Increases in GMC were over 4-fold; upper 95%CI of GMC ratio was 1.36 in the adjusted analysis. Few adverse events were recorded.

Conclusions

This study demonstrates the immunogenicity and safety of TT in CTC at <40 °C for <30 days. The high proportion of participants protected at baseline results in a reduction of power to detect a 5% non-inferiority margin. However, results at a 10% non-inferiority margin, the comparable GMC increases and vaccine's stability demonstrated in the preliminary phase indicate that CTC can be an alternative strategy for TT delivery in situations where cold chain cannot be maintained.     

Astrocyte glycogenolysis is triggered by store‐operated calcium entry and provides metabolic energy for cellular calcium homeostasis

Astrocytic glycogen, the only storage form of glucose in the brain, has been shown to play a fundamental role in supporting learning and memory, an effect achieved by providing metabolic support for neurons. We have examined the interplay between glycogenolysis and the bioenergetics of astrocytic Ca²⁺ homeostasis, by analyzing interdependency of glycogen and store‐operated Ca²⁺ entry (SOCE), a mechanism in cellular signaling that maintains high endoplasmatic reticulum (ER) Ca²⁺ concentration and thus provides the basis for store‐dependent Ca²⁺ signaling. We stimulated SOCE in primary cultures of murine cerebellar and cortical astrocytes, and determined glycogen content to investigate the effects of SOCE on glycogen metabolism. By blocking glycogenolysis, we tested energetic dependency of SOCE‐related Ca²⁺ dynamics on glycogenolytic ATP. Our results show that SOCE triggers astrocytic glycogenolysis. Upon inhibition of adenylate cyclase with 2',5'‐dideoxyadenosine, glycogen content was no longer significantly different from that in unstimulated control cells, indicating that SOCE triggers astrocytic glycogenolysis in a cAMP‐dependent manner. When glycogenolysis was inhibited in cortical astrocytes by 1,4‐dideoxy‐1,4‐imino‐D‐arabinitol, the amount of Ca²⁺ loaded into ER via sarco/endoplasmic reticulum Ca²‐ATPase (SERCA) was reduced, which suggests that SERCA pumps preferentially metabolize glycogenolytic ATP. Our study demonstrates SOCE as a novel pathway in stimulating astrocytic glycogenolysis. We also provide first evidence for a new functional role of brain glycogen, in providing local ATP to SERCA, thus establishing the bioenergetic basis for astrocytic Ca²⁺ signaling. This mechanism could offer a novel explanation for the impact of glycogen on learning and memory. GLIA 2014;62:526–534     

Diagnostic classification of arterial spin labeling and structural MRI in presenile early stage dementia

Because hypoperfusion of brain tissue precedes atrophy in dementia, the detection of dementia may be advanced by the use of perfusion information. Such information can be obtained noninvasively with arterial spin labeling (ASL), a relatively new MR technique quantifying cerebral blood flow (CBF). Using ASL and structural MRI, we evaluated diagnostic classification in 32 prospectively included presenile early stage dementia patients and 32 healthy controls. Patients were suspected of Alzheimer's disease (AD) or frontotemporal dementia. Classification was based on CBF as perfusion marker, gray matter (GM) volume as atrophy marker, and their combination. These markers were each examined using six feature extraction methods: a voxel‐wise method and a region of interest (ROI)‐wise approach using five ROI‐sets in the GM. These ROI‐sets ranged in number from 72 brain regions to a single ROI for the entire supratentorial brain. Classification was performed with a linear support vector machine classifier. For validation of the classification method on the basis of GM features, a reference dataset from the AD Neuroimaging Initiative database was used consisting of AD patients and healthy controls. In our early stage dementia population, the voxelwise feature‐extraction approach achieved more accurate results (area under the curve (AUC) range = 86 ? 91%) than all other approaches (AUC = 57 ? 84%). Used in isolation, CBF quantified with ASL was a good diagnostic marker for dementia. However, our findings indicated only little added diagnostic value when combining ASL with the structural MRI data (AUC = 91%), which did not significantly improve over accuracy of structural MRI atrophy marker by itself. Hum Brain Mapp 35:4916–4931, 2014. © 2014 Wiley Periodicals, Inc .     

Social Validation of the New England Center for Children-Core Skills Assessment

We investigated the social validity of the NECC Core Skills Assessment (NECC-CSA) with parents and professionals as participants. The NECC-CSA is a measurement tool consisting of direct and indirect measures of skills important to all individuals with autism, across the lifespan. Participants (N = 245) were provided with a list of 66 skills, 47 of which were Core Skills from the NECC-CSA, and were asked to indicate which items they considered to be foundational. Participants endorsed items from the NECC-CSA as foundational skills, more than they endorsed the other items. Differences between parents and professionals are described and detailed with respect to individual assessment items. The NECC-CSA consists of socially validated skills that can be taken as a starting point for programs of instruction for individuals with ASDs.