COVID-19 vaccination in pregnancy: How discrepant public health discourses shape responsibility for fetal health.

Early in COVID-19 vaccine rollout, expert recommendations about vaccination while pregnant and breastfeeding changed rapidly. This paper addresses the (re)production of gendered power relations in these expert discourses and recommendations in Canada. We collected texts about COVID-19 vaccine use in pregnancy (N â€‹= â€‹52) that Canadian health organizations (e.g., professional societies, advisory groups, health authorities) and vaccine manufacturers made publicly available online. A discourse analysis was undertaken to investigate intertextuality (relations between texts), social construction (incorporation of assumptions about gender), and contradictions between and within texts. National expert recommendations varied in stating COVID-19 vaccines are recommended, should be offered, or may be offered, while manufacturer texts consistently stated there was no evidence. Provincial and territorial texts reproduced discrepancies between the Society of Obstetricians and Gynaecologists of Canada and National Advisory Committee on Immunization recommendations, including that COVID-19 vaccines should be versus may be offered in pregnancy. Our findings suggest gaps in data and discrepant COVID-19 vaccine recommendations, eligibility, and messaging limit guidance regarding vaccination in pregnancy. We argue that these discrepancies magnified the already common practice of deferring responsibility for the uncertainties of vaccination in pregnancy onto parents and healthcare providers. The deferral of responsibility could be reduced by harmonizing recommendations, regularly updating texts that describe evidence and recommendations, and prioritizing research into disease burden, vaccine safety, and efficacy before vaccine rollout.

Neurological factors and Cesarean section in Australian women with epilepsy.

OBJECTIVES: To analyze the records of the pregnancies of 2283 Australian women with epilepsy in the Australian Register of Antiepileptic Drugs in Pregnancy database to identify neurological factors relevant to the Cesarean sections carried out in these pregnancies. RESULTS: The Cesarean section rate in Australian women overall increased by an average of 0.59% annually over 20 years, from 26.0% to its calculated 2020 value of 37.3%. For the operations in women with epilepsy, the corresponding figures were 0.71% annually, and 34.4% and 48.7%. The average annual rate of increase for pre-labor operations was 0.89% to a 2020 value of 39.1%, the annual rate for operations during labor showing no statistically significant change. Multivariate regression analysis identified a number of characteristics of women with epilepsy that were statistically significantly associated with an increased likelihood of Cesarean section, but of these only seizures continuing to occur in the third trimester and having chronic illness, in particular migraine, were neurological ones. In 70 migraine-affected women, the Cesarean section rate was 51.4%, compared with 39% in the remaining pregnancies (P < 0.05). CONCLUSIONS: Having seizures in the final trimester of pregnancy and having chronic neurological illness, especially migraine, favored Cesarean section being carried out in Australian women with epilepsy, but did not adequately account for the increasing rates of occurrence of the operation over the past 20 years.

Antiepileptic drugs and foetal malformation: analysis of 20 years of data in a pregnancy register.

PURPOSE: This paper reports additional data supplementing earlier publications based on Australian Pregnancy Register (APR) data. METHOD: Over 20 years, the APR has collected Information on pregnancies in Australian women with epilepsy (WWE), untreated WWE and those taking AEDs for other indications. Contact is by telephone, at set intervals. Treatment is not interfered with. Data are analysed using conventional statistical techniques, confidence interval methods, and logistic regression. RESULTS: By 2018, the APR contained details of 2148 pregnancies. AEDs were taken throughout 1972 of the pregnancies (91.8%). The remaining 176 (8.2%) did not receive AEDs, at least early in pregnancy. There were (i) dose-related increased incidences of pregnancies carrying foetal malformations associated with maternal intake of valproate and topiramate when topiramate was a component of AED polytherapy (P < .05), (ii) a similar dose-related trend in relation to carbamazepine intake, (iii) no evidence that levetiracetam and lamotrigine were unsafe from the foetal standpoint, (iv) insufficient data to permit conclusions regarding teratogenicity in relation to other AEDs, and (v) no evidence that pre-conception folate supplementation reduced the hazard of AED-associated foetal malformation. AED polytherapy did not increase foetal hazard unless valproate or topiramate was involved in the AED combination. Genetic factors probably contributed to the malformation hazard. Seizures occurring in earlier pregnancy probably did not contribute to the malformation hazard. CONCLUSIONS: If it were not for the importance of maintaining seizure control, the above findings suggest that it would be better to avoid using certain AEDs, particularly valproate and topiramate, during pregnancy.

Antiepileptic drug polytherapy in pregnant women with epilepsy.

OBJECTIVE: To study seizure control and rates of foetal malformation in pregnancies of women with epilepsy treated with antiepileptic drug polytherapy. METHODS: The use of conventional statistical methods to analyse the Australian Pregnancy Register records of 1810 pregnancies in women with epilepsy, 508 treated with antiepileptic drug polytherapy. RESULTS: Polytherapy-treated pregnancies were less often seizure free than monotherapy-treated ones, for both focal (36.0% vs 51.9%: P < .05) and primary generalized epilepsies (41.1% vs 69.3%; P < .05). Drug combinations with dissimilar and similar mechanisms of action achieved similar rates of seizure freedom during pregnancy (36.3% vs 38.3%). The increased rate of malformed foetuses in polytherapy pregnancies depended on valproate or topiramate being in the drug combinations. The combinations of lamotrigine and levetiracetam offered the chance of seizure control and foetal safety. CONCLUSIONS: In pregnancy, the use of antiepileptic drug combinations is not necessarily disadvantageous to mother and foetus if valproate and topiramate are avoided.

Do health care providers trust product monograph information regarding use of vaccines in pregnancy? A qualitative study.

BACKGROUND: Influenza immunization is recommended in pregnancy to prevent severe infections in pregnant women and newborns, yet vaccine uptake remains low. Studies suggest that cautionary language in vaccine product monographs regarding safety and use in pregnancy affects health care providers' perceptions of vaccine safety and how they counsel pregnant women. OBJECTIVE: To conduct a qualitative analysis of health care provider perceptions of the safety of inactivated influenza vaccines and their recommendations for use in pregnancy based on product monograph language statements. METHODS: Health care providers were recruited at two international health conferences and from teaching programs in Ethiopia, Ghana, Uganda, and Laos during September and October 2015. After reading the product monograph excerpts for three licensed inactivated influenza vaccines, participants completed a ten-item online survey with quantitative and qualitative components that captured perceptions of vaccine safety. RESULTS: Health care providers identified a lack of trust in manufacturers' and product monograph information. They perceived product monograph language as ambiguous and not "up-to-date" with current evidence. Health care providers wanted product monograph language that clearly conveyed evidence for the risks and benefits of the vaccine in an understandable manner. CONCLUSION: This study suggests that adopting best practices in the wording of product monographs would help to support evidence-based use of vaccines in pregnant women.

Predicting epileptic seizure control during pregnancy.

OBJECTIVE: The objective of the study was to assess whether the type of seizure disorder present in the prospective mother with epilepsy, her use of antiepileptic drugs (AEDs) in early pregnancy, and her seizure control before pregnancy help predict her prospects for seizure freedom throughout pregnancy. METHODS: This paper is based on data accumulated in the Australian Pregnancy Register (APR) between 1998 and late 2016. Information was analyzed concerning epileptic seizure occurrence and AED therapy taken before and during pregnancy, using simple statistical and confidence interval (C.I.) methods, mainly relative risk (R.R.) calculations. RESULTS: After excluding pregnancies lost to follow-up, and those that ended prematurely because of spontaneous abortion or stillbirth, 1939 pregnancies were available for study. Seizures had occurred during pregnancy in 829 (42.8%), and convulsive seizures in 385 (19.9%). Seizures of any type occurred in 78.4% of pregnancies where seizures had occurred in the previous year (active epilepsy) and in 22.3% of those associated with inactive epilepsy. Seizures of any type had occurred in 54.9% of pregnancies initially unexposed to AEDs and in 45.5% of those treated with AEDs throughout. The corresponding figures for convulsive seizures during pregnancy were 31.7% and 22.3%. There was statistically significant evidence that, in women with epilepsy (WWE), having a seizure disorder that was active in the prepregnancy year and one untreated in early pregnancy was associated with decreased prospects of seizure freedom during pregnancy. Decreased chances of seizure-free pregnancies in women with focal epilepsies and those treated with multiple AEDs were probably explained by greater frequencies of active seizure disorders in these patient categories. CONCLUSIONS: Women with epilepsy who experience seizures in the year prior to pregnancy appear 3 or 4 times more likely to continue to have seizures during pregnancy than women whose seizures are fully controlled prior to pregnancy. Not taking AEDs in early pregnancy also increases the hazard for seizure occurrence in pregnancy.

Improving transfusion education for junior doctors; exploring UK experiences.

OBJECTIVES: To provide evidence-based guidance on how transfusion education should be delivered to junior doctors by employing established qualitative research methodology. BACKGROUND: There is a global call for increased transfusion education for doctors to support the delivery of evidence-based practice. Education is reported as an effective measure to improve transfusion practice, although there is a paucity of research evaluating how this should be effectively delivered. METHODS: Serial focus groups with junior doctors and relevant healthcare professionals explored experiences of, and reactions to, education and competency assessments in transfusion, which were audio-recorded and transcribed. Temporal and final analysis, performed by two independent assessors, informed subsequent recruitment, analysis and challenging of emerging theories - until saturation was reached. RESULTS: Eight focus groups were held involving 53 personnel, 77% of whom were junior doctors. Current transfusion education for doctors in the UK is reliant on e-learning and 'cascade training' (on-the-job from senior clinicians/nursing staff). E-learning is viewed as a 'tick box exercise'. There is a call for relevant and practical continuing education delivered face to face by good educators in an environment away from clinical practice. Preferred methods include small group and simulation learning based on real-life cases. In contrast to practical competency, the assessment of clinical competency is deemed unfeasible. CONCLUSION: Current methods of transfusion education employed in the UK are unsatisfactory to ensure safe transfusion practice. Ongoing education is deemed necessary throughout career progression, and suggested improvements include increased emphasis on face-to-face teaching and simulation training. Employed educational methods and decision support tools require appropriate evaluation.

Antiepileptic drugs, foetal malformations and spontaneous abortions.

BACKGROUND: Some recent studies have found an association between foetal malformations in earlier antiepileptic drug (AED)-exposed pregnancies and an increased hazard of such malformations in subsequent pregnancies. We investigated this matter further, and also considered the possible role of spontaneous abortions in previous pregnancies, in this situation. METHODS: Analysis of foetal malformation data for current and previous pregnancies in women taking AEDs and women with untreated epilepsy in the Australian Register of Antiepileptic Drugs in Pregnancy (APR) from 1999 to late 2014. RESULTS: Antiepileptic drug-treated women with either a malformed foetus or a spontaneous abortion in their previous pregnancy had a statistically significant twofold to threefold increased risk of foetal malformation in their next pregnancy, compared with similarly treated women with normal offspring in their previous pregnancy. This was not seen in the same circumstances in women with untreated epilepsy. On AED treatment, the women were more likely to have spontaneous abortions than in their previous untreated pregnancies. Possibly some of the increased abortion rate resulted from drug-related malformations that were incompatible with continuing intrauterine survival. CONCLUSIONS: In assessing the hazard of an AED-treated woman having a malformed foetus, it is important to know both the AEDs being taken and, if there had been a previous pregnancy, whether a foetal malformation or a spontaneous abortion occurred in it.

Transfusion e-learning for junior doctors: the educational role of 'LearnBloodTransfusion'.

OBJECTIVES: To critically analyse the educational role of 'LearnBloodTransfusion' (LBT) in enabling junior doctors to be safe transfusion practitioners. BACKGROUND: Computer assisted learning, or e-learning, enables the educational needs of learners to be flexibly met. Education and learning in the health service is necessary to ensure appropriate skills, behaviours and training are provided, to assure excellence in healthcare delivery. LBT is a computer-assisted learning programme that has been designed to meet the needs of practitioners involved in the transfusion process. It is widely adopted across the NHS and within undergraduate medical training. METHOD: Critical analysis of LBT relating to learning outcomes, assessment tools and functionality, as pertaining to the transfusion curriculum for junior doctors. RESULTS: Learning outcomes of LBT adhere to Bloom's taxonomy, addressing cognitive, psycho-motor and affective domains of learning. LBT flexibly meets differing styles, strategies and levels of learning although there is scope to enhance the computer-facilitated flexibility of this learning tool. LBT is unable to address the complex clinical reasoning skills or clinical competency required by doctors in the transfusion process. CONCLUSION: LBT uses effective educational methodology to deliver the transfusion curriculum to junior doctors although LBT must be complemented by additional methods of learning to ensure clinical competency.

Greek adaptation and validation of the Ankylosing Spondylitis Quality of Life (ASQoL) measure.

BACKGROUND: Ankylosing Spondylitis (AS) is a chronic rheumatic disease that has a significant impact on patient's quality of life (QoL). The Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire is a disease-specific patient-reported outcome measure for assessing QoL in AS. While the ASQoL has been adapted for use in 46 countries worldwide, a Greek language version of the measure has not been available and was required for an international clinical trial. AIM: The aim was to develop and assess the psychometric properties of a Greek language version of the ASQoL. METHODS: The adaptation of the ASQoL into Greek involved three procedures: translation, assessment of face and content validity, and formal validation. The measure was translated into Greek using two translation panels. Cognitive debriefing interviews were employed to determine face and content validity. Finally, the translation's psychometric properties were examined by administering it on two occasions, with a 14-day interval. The Nottingham Health Profile (NHP) was used as a comparator measure. RESULTS: The ASQoL proved straightforward to translate into Greek and interviewees found it relevant, comprehensible and easy to complete.  The measure had good internal consistency (α =0.92) and test-retest reliability (r =0.98). Predicted correlations with the NHP provided evidence of the convergent validity of the two measures. Construct validity was confirmed by the measure's ability to distinguish groups of AS patients varying by perceived disease severity and general health. CONCLUSIONS: The Greek ASQoL has been shown to be well-accepted, reliable and valid and can be recommended for use in clinical studies and routine clinical practice in AS. Hippokratia 2015; 19 (2):119-124.

Community participation patterns among preschool-aged children who have received Part C early intervention services.

BACKGROUND: We examined activity-specific patterns and child, family and environmental correlates of participation restriction in nine community-based activities among preschoolers with disabilities who have received Part C early intervention services. METHODS: Data were gathered from a subsample of 1509 caregivers whose children (mean age = 67.7 months) had enrolled in the National Early Intervention Longitudinal Study (NEILS) and completed a 40-min computerized telephone interview or 12-page mailed survey. Data were analysed on cases with complete data on the variables of interest. Bivariate relationships were examined between variables, including patterns of co-reporting participation difficulties for pairs of community activities. RESULTS: Caregivers were more than twice as likely to report difficulty in one activity (20%) than difficulties in 2-3, 4-5, or 6-9 activities. Co-reporting paired difficulties was strong for activities pertaining to neighbourhood outings but less conclusive for community-sponsored activities and recreation and leisure activities. Our data show strong and positive associations between child functional limitations in mobility, toileting, feeding, speech, safety awareness, and friendships and participation difficulty in 7-9 activities. Lower household income was associated with participation difficulty in 7 out of 9 activities and difficulty managing problematic behaviour was strongly associated with participation difficulty in all 9 activities. Each of the three environmental variables (limited access to social support, transportation and respite) was associated with participation restrictions in all nine activities. CONCLUSION: Results provide practitioners with detailed descriptive knowledge about modifiable factors related to the child, family and environment for promoting young children's community participation, as well information to support development of a comprehensive assessment tool for research and intervention planning to promote community participation for children enrolled in early intervention.

Hospital readmission in persons with stroke following postacute inpatient rehabilitation.

BACKGROUND: Readmission is an important quality indicator following acute care hospitalization. We examined factors associated with hospital readmission in persons with stroke following postacute inpatient rehabilitation. METHODS: Prospective cohort study including 674 persons with stroke who received rehabilitation at 11 facilities located in eight states and the District of Columbia. Measures included hospital readmission within 3 months of discharge, sociodemographic characteristics, length of stay, primary payment source, comorbidities, stroke type, standardized assessments of motor and cognitive function, depressive symptoms, and social support. RESULTS: Mean age was 71.5 years (SD = 10.5). Twenty-five percent of patients reported high depressive symptoms. Overall, 18% (n = 122) of the sample was rehospitalized. Univariate analyses showed that people who were rehospitalized were more likely (p < .05) to be non-Hispanic white, married, demonstrate less functional independence at discharge, experience longer lengths of stay in rehabilitation, and report more depressive symptoms and lower social support. In the fully adjusted multivariable hierarchical generalized linear model, motor functional status (OR = 0.98, 95% CI 0.96-0.99), depressive symptoms (OR = 1.80, 95% CI 1.06-3.05), and social support (OR = 2.28, 95% CI 1.29-4.03) remained statistically significant. In addition, a minority-by-depressive symptoms interaction term also reached statistical significance. CONCLUSION: Functional status, depressive symptoms, and social support were important predictors of hospital readmission. These variables are not included in most administrative data sets. Future research to develop useful risk-adjustment models for rehospitalization following postacute inpatient rehabilitation services should include large diverse samples and explore practical sources for additional meaningful information.

Is lamotrigine a significant human teratogen? Observations from the Australian Pregnancy Register.

Lamotrigine (LTG) is increasingly being prescribed in pregnancy for women with epilepsy in place of valproate (VPA), because of the teratogenic risks associated with the latter. It is therefore important to know the teratogenic hazard associated with LTG, relative to VPA and to other commonly used antiepileptic drugs (AEDs). Data from the Australian Register of Antiepileptic Drugs in Pregnancy was examined to determine the incidence of teratogenicity determined 1 year from completion of pregnancy in women who took AEDs in monotherapy during pregnancy. Compared with a 3.4% malformation incidence in women who took no AEDs (N = 118), the incidences for LTG (N = 243), carbamazepine (CBZ) (N = 302) and VPA (N = 224) were, respectively, 4.9%, 5.3% and 15.2%, the latter statistically significantly greater than the risk for no AED therapy in pregnant women with epilepsy. Logistic regression analysis showed no tendency for foetal hazard to increase with increasing LTG dose in pregnancy, unlike the situation for VPA. However, seizure control in pregnancy tended to be not as good in the women taking LTG compared with those taking VPA, though the data examined were not adequate to permit definite conclusions regarding this matter. We conclude that LTG monotherapy in pregnancy is safer than valproate monotherapy from the point of view of foetal malformations, and no more hazardous in this regard than therapy with other commonly used AEDs.

Concordance between common dry eye diagnostic tests.

AIM: Large variations in results of diagnostic tests for mild to moderate dry eye are widely recognised. The purpose of this study was to assess if there was concordance between common dry eye diagnostic tests. METHODS: A total of 91 subjects were recruited to the study. The tear film and ocular surface were evaluated using the phenol red thread test (PRT), tear film break-up time (TBUT), biomicroscopic examination and impression cytological assessment of conjunctival goblet cells. Dry eye symptoms were assessed using McMonnies' dry eye questionnaire (MQ) and statistical correlations between all tests were assessed. RESULTS: This study cohort did not include severe aqueous deficient dry eye patients as determined by the PRT. A statistically significant difference was noted between PRT results and all other tests (p

Goal setting and attainment in Alzheimer's disease patients treated with donepezil.

OBJECTIVES: To understand the treatment goals of Alzheimer's disease (AD) patients, carers, and physicians; to estimate whether clinically important goals are met during treatment with donepezil; and to compare a measure of goal attainment with standard measures used to evaluate AD treatment. METHODS: In a 12 month phase IV trial, 108 patients with mild to moderate AD, their primary carers, and treating physicians set goals assigned to five domains, using Goal Attainment Scaling (GAS) as the primary outcome. Goal attainment was assessed quarterly. GAS scores were correlated with standard outcomes, including the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog), and the Clinician's Interview-Based Impression of Change-Plus (CIBIC-plus). RESULTS: Physicians set fewer goals (342, mean (SD) per patient=3 (1)) than patients/carers (855, mean=9 (3)), particularly in leisure (20% by physicians compared with 76% by patients/carers), and social interaction (24% versus 49%). Physicians observed statistically significant improvement in global goal attainment for six months, and patients/carers for nine months. Patients/carers described consistent goal attainment, whereas physicians observed variable effects, such as decline in cognition but improved social interaction and behaviour. Physician global GAS scores correlated highly with the CIBIC-plus at weeks 12 (r= -0.82) and 52 (r=-0.80), but not with the ADAS-cog (r=0.12 and r=-0.45, respectively). Patient/carer global GAS scores correlated moderately with the physician's CIBIC-plus (week 12 r=-0.51; week 52 r=-0.56), and nominally with the ADAS-cog. CONCLUSIONS: Patients/carers and physicians differ in their expectations and impressions of treatment effects. Clinically important changes correlated only modestly with psychometric tests. Attainment of treatment goals does not accord with a simplistic model in which successful AD treatment means that all declines uniformly improve.

Identification of Salmonella typhi genes expressed within macrophages by selective capture of transcribed sequences (SCOTS).

Salmonella enterica serovar Typhi (S. typhi) is a human-restricted pathogen which causes typhoid fever. Relatively little is known about S. typhi host interaction as animal models of this disease are severely limited by the lack of virulence of S. typhi in other hosts. The virulence of other Salmonella serovars in animal models is dependent on the abilities of these bacteria to survive within host macrophages. We have used selective capture of transcribed sequences (SCOTS) to identify S. typhi genes expressed during growth in human macrophages. This positive cDNA selection technique identified 28 distinct clones representing previously identified as well as novel, uncharacterized and hypothetical gene sequences that are expressed intracellularly. Transcripts for the Vi capsular antigen and genes whose products are involved in stress responses and nutrient acquisition were obtained from intracellular bacteria using SCOTS. Most of these clones are present in the S. typhimurium genome and are also expressed in murine macrophages. Nineteen of these gene sequences were disrupted insertionally in S. typhi, and most of the resulting mutants exhibited a lower level of survival within macrophages compared with the wild-type parent strain. Mutant strains, transformed with a copy of a wild-type gene, exhibited a macrophage survival level similar to that of the parental strain.

Prevalence of cognitive impairment and dementia as defined by neuropsychological test performance.

The Canadian Study of Health and Aging (CSHA) provided a population-based estimate of the prevalence of dementia of 8% for those aged 65 and older. Other studies have produced both higher and lower prevalence estimates. Factors that may contribute to these differences include: the use of or the reliance on neuropsychological testing, the consideration of functional impairment as a criterion for dementia and the inclusion of the category of cognitive impairment without dementia in the diagnostic classification. We examined the impact of these methodological factors by reanalyzing the CSHA database for those individuals who completed neuropsychological testing. If the diagnosis of dementia required only impaired neuropsychological test performance, there was an increased prevalence of dementia relative to the clinical consensus diagnosis, but including the requirement of functional impairment for dementia reduced this discrepancy. The findings illustrate the need for clear operationalization of diagnostic criteria for cognitive impairment and dementia in neuroepidemiological studies.

Dynamics of cognitive aging: distinguishing functional age and disease from chronologic age in a population.

This paper introduces a methodological approach to the dynamics of cognitively normal (i.e., successful) aging compared with aging accompanied by different types of cognitive impairment and dementia. Using secondary analysis of a national representative database (Canadian Study of Health and Aging, 1991-1992), the authors show that the occurrence of an adverse event (symptom, sign, or disease), or the accumulation of a number of events, may be modeled as a logistic function of chronologic age in a population. In the cognitively normal, a linear relation between the logarithm of the odds of events and chronologic age was present for the majority of symptoms and signs. This regression represents the accumulation of each sign in a cognitively successful, aging population. The authors then estimated which ages for this cognitively unimpaired group correspond to the odds of the occurrence of symptoms found for a cognitively impaired population at any given chronologic age. This may be regarded as functional age, based upon the accumulation of a particular functional deficit in the impaired population, analogous to the concept of frailty. The dynamics of aging are a complex process of accumulation of deficits (morbidity), whereby decline from some previously healthy level of synergistically associated symptoms and signs results in distinct patterns of disease and staging. The modeling of these dynamics takes us a step further toward the definition and refinement of disease and normal aging.