Protocol of a cluster randomized trial of an educational intervention to increase knowledge of living donor kidney transplant among potential transplant candidates

BackgroundThe best treatment option for end-stage renal disease is usually a transplant, preferably a live donor kidney transplant (LDKT). The most effective ways to educate kidney transplant candidates about the risks, benefits, and process of LDKT remain unknown.Methods/designWe report the protocol of the Enhancing Living Donor Kidney Transplant Education (ELITE) Study, a cluster randomized trial of an educational intervention to be implemented during initial transplant evaluation at a large, suburban U.S. transplant center. Five hundred potential transplant candidates are cluster randomized (by date of visit) to receive either: (1) standard-of-care ("usual") transplant education, or (2) intensive education that is based upon the Explore Transplant series of educational materials. Intensive transplant education includes viewing an educational video about LDKT, receiving print education, and meeting with a transplant educator. The primary outcome consists of knowledge of the benefits, risks, and process of LDKT, assessed one week after the transplant evaluation. As a secondary outcome, knowledge and understanding of LDKT are assessed 3 months after the evaluation. Additional secondary outcomes, assessed one week and 3 months after the evaluation, include readiness, self-efficacy, and decisional balance regarding transplant and LDKT, with differences assessed by race. Although the unit of randomization is the date of the transplant evaluation visit, the unit of analysis will be the individual potential transplant candidate.DiscussionThe ELITE Study will help to determine how education in a transplant center can best be designed to help Black and non-Black patients learn about the option of LDKT.Trial registrationClinicaltrials.gov number NCT01261910

Maternal iodine status in a multi-ethnic UK birth cohort:Associations with child cognitive and educational development

Background: Maternal iodine requirements increase during pregnancy to supply thyroid hormones critical for fetal neurodevelopment. Iodine insufficiency may result in poorer cognitive or child educational outcomes but current evidence is sparse and inconsistent. Objectives: To quantify the association between maternal iodine status and child educational outcomes. Methods: Urinary iodine concentrations (UIC) and iodine/creatinine ratios (I:Cr) were measured in 6971 mothers at 26-28 weeks' gestation participating in the Born in Bradford cohort. Maternal iodine status was examined in relation to child school achievement (early years foundation stage (EYFS), phonics, and Key Stage 1 (KS1)), other learning outcomes, social and behavioural difficulties, and sensorimotor control in 5745 children aged 4-7 years. Results: Median (interquartile range) UIC was 76 µg/L (46, 120), and I:Cr was 83 µg/g (59, 121). Overall, there was no strong or consistent evidence to support associations between UIC or I:Cr and neurodevelopmental outcomes. For instance, predicted EYFS and phonics scores (primary outcomes) at the 25th vs 75th I:Cr percentiles (99% confidence intervals) were similar, with no evidence of associations: EYFS scores were 32 (99% CI 31, 33) and 33 (99% CI 32, 34), and phonics scores were 34 (99% CI 33, 35) and 35 (99% CI 34, 36), respectively. Conclusions: In the largest single study of its kind, there was little evidence of detrimental neurodevelopmental outcomes in children born to pregnant women with iodine insufficiency as defined by World Health Organization–outlined thresholds. Alternative functional biomarkers for iodine status in pregnancy and focused assessment of other health outcomes may provide additional insight.</p

Maternal iodine status, intrauterine growth, birth outcomes and congenital anomalies in a UK birth cohort.

BACKGROUND: Severe iodine insufficiency in pregnancy has significant consequences, but there is inadequate evidence to indicate what constitutes mild or moderate insufficiency, in terms of observed detrimental effects on pregnancy or birth outcomes. A limited number of studies have examined iodine status and birth outcomes, finding inconsistent evidence for specific outcomes. METHODS: Maternal iodine status was estimated from spot urine samples collected at 26-28 weeks' gestation from 6971 mothers in the Born in Bradford birth cohort. Associations with outcomes were examined for both urinary iodine concentration (UIC) and iodine-to-creatinine ratio (I:Cr). Outcomes assessed included customised birthweight (primary outcome), birthweight, small for gestational age (SGA), low birthweight, head circumference and APGAR score. RESULTS: There was a small positive association between I:Cr and birthweight in adjusted analyses. For a typical participant, the predicted birthweight centile at the 25th percentile of I:Cr (59 μg/g) was 2.7 percentage points lower than that at the 75th percentile of I:Cr (121 μg/g) (99% confidence interval (CI) 0.8 to 4.6), birthweight was predicted to be 41 g lower (99% CI 13 to 69) and the predicted probability of SGA was 1.9 percentage points higher (99% CI 0.0 to 3.7). There was no evidence of associations using UIC or other birth outcomes, including stillbirth, preterm birth, ultrasound growth measures or congenital anomalies. CONCLUSION: Lower maternal iodine status was associated with lower birthweight and greater probability of SGA. Whilst small, the effect size for lower iodine on birthweight is comparable to environmental tobacco smoke exposure. Iodine insufficiency is avoidable, and strategies to avoid deficiency in women of reproductive age should be considered. TRIAL REGISTRATION: ClinicalTrials.gov NCT03552341. Registered on June 11, 2018

Maternal iodine status, intrauterine growth, birth outcomes and congenital anomalies in a UK birth cohort

Abstract: Background: Severe iodine insufficiency in pregnancy has significant consequences, but there is inadequate evidence to indicate what constitutes mild or moderate insufficiency, in terms of observed detrimental effects on pregnancy or birth outcomes. A limited number of studies have examined iodine status and birth outcomes, finding inconsistent evidence for specific outcomes. Methods: Maternal iodine status was estimated from spot urine samples collected at 26–28 weeks’ gestation from 6971 mothers in the Born in Bradford birth cohort. Associations with outcomes were examined for both urinary iodine concentration (UIC) and iodine-to-creatinine ratio (I:Cr). Outcomes assessed included customised birthweight (primary outcome), birthweight, small for gestational age (SGA), low birthweight, head circumference and APGAR score. Results: There was a small positive association between I:Cr and birthweight in adjusted analyses. For a typical participant, the predicted birthweight centile at the 25th percentile of I:Cr (59 μg/g) was 2.7 percentage points lower than that at the 75th percentile of I:Cr (121 μg/g) (99% confidence interval (CI) 0.8 to 4.6), birthweight was predicted to be 41 g lower (99% CI 13 to 69) and the predicted probability of SGA was 1.9 percentage points higher (99% CI 0.0 to 3.7). There was no evidence of associations using UIC or other birth outcomes, including stillbirth, preterm birth, ultrasound growth measures or congenital anomalies. Conclusion: Lower maternal iodine status was associated with lower birthweight and greater probability of SGA. Whilst small, the effect size for lower iodine on birthweight is comparable to environmental tobacco smoke exposure. Iodine insufficiency is avoidable, and strategies to avoid deficiency in women of reproductive age should be considered. Trial registration: ClinicalTrials.gov NCT03552341. Registered on June 11, 2018

Maternal iodine status in a multi-ethnic UK birth cohort: associations with autism spectrum disorder.

BACKGROUND: Maternal iodine requirements increase during pregnancy to supply thyroid hormones essential for fetal brain development. Maternal iodine deficiency can lead to hypothyroxinemia, a reduced fetal supply of thyroid hormones which, in the first trimester, has been linked to an increased risk of autism spectrum disorder (ASD) in the child. No study to date has explored the direct link between maternal iodine deficiency and diagnosis of ASD in offspring. METHODS: Urinary iodine concentrations (UIC) and iodine/creatinine ratios (I:Cr) were measured in 6955 mothers at 26-28 weeks gestation participating in the Born in Bradford (BiB) cohort. Maternal iodine status was examined in relation to the probability of a Read (CTV3) code for autism being present in a child's primary care records through a series of logistic regression models with restricted cubic splines. RESULTS: Median (inter-quartile range) UIC was 76 μg/L (46, 120) and I:Cr was 83 μg/g (59, 121) indicating a deficient population according to WHO guidelines. Ninety two children (1·3%) in our cohort had received a diagnosis of ASD by the census date. Overall, there was no evidence to support an association between I:Cr or UIC and ASD risk in children aged 8-12 years (p = 0·3). CONCLUSIONS: There was no evidence of an increased clinical ASD risk in children born to mothers with mild-to-moderate iodine deficiency at 26 weeks gestation. Alternative functional biomarkers of exposure and a wider range of conditions may provide further insight

The genomic landscape of balanced cytogenetic abnormalities associated with human congenital anomalies

Despite the clinical significance of balanced chromosomal abnormalities (BCAs), their characterization has largely been restricted to cytogenetic resolution. We explored the landscape of BCAs at nucleotide resolution in 273 subjects with a spectrum of congenital anomalies. Whole-genome sequencing revised 93% of karyotypes and demonstrated complexity that was cryptic to karyotyping in 21% of BCAs, highlighting the limitations of conventional cytogenetic approaches. At least 33.9% of BCAs resulted in gene disruption that likely contributed to the developmental phenotype, 5.2% were associated with pathogenic genomic imbalances, and 7.3% disrupted topologically associated domains (TADs) encompassing known syndromic loci. Remarkably, BCA breakpoints in eight subjects altered a single TAD encompassing MEF2C, a known driver of 5q14.3 microdeletion syndrome, resulting in decreased MEF2C expression. We propose that sequence-level resolution dramatically improves prediction of clinical outcomes for balanced rearrangements and provides insight into new pathogenic mechanisms, such as altered regulation due to changes in chromosome topology

Sex roles and career goals of university women

Difficulties in predicting female occupational choices according to the theories developed for men have stimulated research into components of a model effective for women. The objective of the present study was to investigate the usefulness of self concept measures in determining the masculinity or femininity of occupations chosen by female undergraduates at a Canadian university. The ninety subjects who participated in the study were chosen for their enrollment in one of three fields defined by previous research as traditionally feminine or in one of three fields defined as traditionally masculine. The two aspects of self concept considered relevant to the sex stereotype of vocational field were sex role stereotyping and self-esteem. The Bern Sex Role Inventory used to assess the former variable, allowed subjects to endorse both masculine and feminine traits, thus providing an index of psychological androgyny as well as an index of stereotypic masculinity or femininity. Self-esteem was also considered from more than one perspective; that of personal and interpersonal functioning and of academic functioning. The results of the study revealed that the subjects' sex role orientation did not correspond to the sex stereotype associated with their fields of specialization. Similarly, statistically significant differences in self-esteem in either the personal or achievement areas emerged from the comparison among career groups. There was, however, a nonsignificant tendency for women in Science to have higher self-esteem in the achievement area than women in the remaining five groups. When self-esteem relationship in the achievement area between sex typing and self-esteem were examined, however, it was apparent that absolute levels of masculinity were significantly related ±o levels of self-esteem in both the areas being measured. The effects on self-esteem of femininity and androgyny were not statistically significant. In the case of the femininity scores, there were certain deviations from the normative data for the Bern Sex Role Inventory. Further consideration of these findings in terms of the instruments employed led to a factor analysis of the Bern Sex Role Inventory. Four factors were obtained. They are identified as scales measuring the constructs Dominance, Independence, Nurturance, and Passivity. Utilizing these newly designed scales, an analysis was made of the previous statistically non-significant relationships. While sex of field could still not be predicted according to scores on these factors, predictions regarding levels of self-esteem were refined by use of factor scores. By thus isolating the independent effects of the two feminine factors--Nurturance and Passivity--upon Inter/Personal self-esteem, the source of the low correlations for femininity was identified. The positive effects of the Nurturance factor were counteracted by the negative effects of the Passivity factor, resulting in a low correlation with self-esteem and with Social Desirability for the original Femininity scale. The two aspects of Masculinity which were defined by the factor analysis also bore differing, although not opposite relationships to the self-esteem criteria. Qualities denoting Independence were of most importance in explaining levels of self-esteem in the personal and interpersonal areas, while traits suggestive of Dominance were most relevant to self-esteem in the achievement area. The effectiveness of sex role stereotyping in predicting the sex stereotype of women's career choices was therefore not confirmed by the results of the present study. The relevance of self-esteem as a variable which moderates the predictive ability of other determinants of career choice was similarly unconfirmed. A number of reasons were postulated as to why the results differ from previous studies on patterns of career choice among women. Recommendations were made for further research into the measurement of psychological androgyny and its significance to women's career aspirations.Education, Faculty ofEducational and Counselling Psychology, and Special Education (ECPS), Department ofGraduat

Protocol of a cluster randomized trial of an educational intervention to increase knowledge of living donor kidney transplant among potential transplant candidates.

BackgroundThe best treatment option for end-stage renal disease is usually a transplant, preferably a live donor kidney transplant (LDKT). The most effective ways to educate kidney transplant candidates about the risks, benefits, and process of LDKT remain unknown.Methods/designWe report the protocol of the Enhancing Living Donor Kidney Transplant Education (ELITE) Study, a cluster randomized trial of an educational intervention to be implemented during initial transplant evaluation at a large, suburban U.S. transplant center. Five hundred potential transplant candidates are cluster randomized (by date of visit) to receive either: (1) standard-of-care ("usual") transplant education, or (2) intensive education that is based upon the Explore Transplant series of educational materials. Intensive transplant education includes viewing an educational video about LDKT, receiving print education, and meeting with a transplant educator. The primary outcome consists of knowledge of the benefits, risks, and process of LDKT, assessed one week after the transplant evaluation. As a secondary outcome, knowledge and understanding of LDKT are assessed 3 months after the evaluation. Additional secondary outcomes, assessed one week and 3 months after the evaluation, include readiness, self-efficacy, and decisional balance regarding transplant and LDKT, with differences assessed by race. Although the unit of randomization is the date of the transplant evaluation visit, the unit of analysis will be the individual potential transplant candidate.DiscussionThe ELITE Study will help to determine how education in a transplant center can best be designed to help Black and non-Black patients learn about the option of LDKT.Trial registrationClinicaltrials.gov number NCT01261910