SummaryBackgroundIntrahepatic cholestasis of pregnancy, characterised by maternal pruritus and increased serum bile acid concentrations, is associated with increased rates of stillbirth, preterm birth, and neonatal unit admission. Ursodeoxycholic acid is widely used as a treatment without an adequate evidence base. We aimed to evaluate whether ursodeoxycholic acid reduces adverse perinatal outcomes in women with intrahepatic cholestasis of pregnancy.MethodsWe did a double-blind, multicentre, randomised placebo-controlled trial at 33 hospital maternity units in England and Wales. We recruited women with intrahepatic cholestasis of pregnancy, who were aged 18 years or older and with a gestational age between 20 weeks and 40 weeks and 6 days, with a singleton or twin pregnancy and no known lethal fetal anomaly. Participants were randomly assigned 1:1 to ursodeoxycholic acid or placebo, given as two oral tablets a day at an equivalent dose of 500 mg twice a day. The dose could be increased or decreased at the clinician's discretion, to a maximum of four tablets and a minimum of one tablet a day. We recommended that treatment should be continued from enrolment until the infant's birth. The primary outcome was a composite of perinatal death (in-utero fetal death after randomisation or known neonatal death up to 7 days after birth), preterm delivery (<37 weeks' gestation), or neonatal unit admission for at least 4 h (from birth until hospital discharge). Each infant was counted once within this composite. All analyses were done according to the intention-to-treat principle. The trial was prospectively registered with the ISRCTN registry, number 91918806.FindingsBetween Dec 23, 2015, and Aug 7, 2018, 605 women were enrolled and randomly allocated to receive ursodeoxycholic acid (n=305) or placebo (n=300). The primary outcome analysis included 304 women and 322 infants in the ursodeoxycholic acid group, and 300 women and 318 infants in the placebo group (consent to use data was withdrawn for 1 woman and 2 infants). The primary composite outcome occurred in 74 (23%) of 322 infants in the ursodeoxycholic acid group and 85 (27%) of 318 infants in the placebo group (adjusted risk ratio 0·85 [95% CI 0·62–1·15]). Two serious adverse events were reported in the ursodeoxycholic acid group and six serious adverse events were reported in the placebo group; no serious adverse events were regarded as being related to treatment.InterpretationTreatment with ursodeoxycholic acid does not reduce adverse perinatal outcomes in women with intrahepatic cholestasis of pregnancy. Therefore, its routine use for this condition should be reconsidered.FundingNational Institute for Health Research Efficacy and Mechanism Evaluation Programme.
It has recently been demonstrated that metrics of structural validity are severely underreported in social and personality psychology. We comprehensively assessed structural validity in a uniquely large and varied data set ( N = 144,496 experimental sessions) to investigate the psychometric properties of some of the most widely used self-report measures ( k = 15 questionnaires, 26 scales) in social and personality psychology. When the scales were assessed using the modal practice of considering only internal consistency, 88% of them appeared to possess good validity. Yet when validity was assessed comprehensively (via internal consistency, immediate and delayed test-retest reliability, factor structure, and measurement invariance for age and gender groups), only 4% demonstrated good validity. Furthermore, the less commonly a test was reported in the literature, the more likely the scales were to fail that test (e.g., scales failed measurement invariance much more often than internal consistency). This suggests that the pattern of underreporting in the field may represent widespread hidden invalidity of the measures used and may therefore pose a threat to many research findings. We highlight the degrees of freedom afforded to researchers in the assessment and reporting of structural validity and introduce the concept of validity hacking ( v-hacking), similar to the better-known concept of p-hacking. We argue that the practice of v-hacking should be acknowledged and addressed.
In the present article we re-examine one of the most deeply entrenched assumptions in modern attitude research, namely, that A Brief history of AttitudesThe study of attitudes and their essential architecture-although more than 80 years old-continues to command considerable attention within social psychology (see Albarracin, Johnson, & Zanna, 2005;
Studies show that misconceptions about psychology are pervasive. This study examined how the strength of prior beliefs and the sources of misinformation relate to conceptual change following an introductory psychology course. Ninety introductory psychology students completed a 36-item "Psychological Information" questionnaire. Testing during the 1 st day of the semester showed 38.5% accuracy whereas testing during the last week showed 66.3% accuracy. These results suggest that misconceptions remain prevalent but can be reduced by taking an introductory psychology course. Our data also indicate that strength of belief is an important transitional variable that may reflect the process of change. Finally, although personal experience and media are important sources of misinformation, we found that they do not promote strongly held beliefs.
We introduce the Relational Responding Task (RRT) as a tool for capturing beliefs at the implicit level. Flemish participants were asked to respond as if they believed that Flemish people are more intelligent than immigrants (e.g., respond “true” to the statement “Flemish people are wiser than immigrants”) or to respond as if they believed that immigrants are more intelligent than Flemish people (e.g., respond “true” to the statement “Flemish people are dumber than immigrants”). The difference in performance between these two tasks correlated with ratings of the extent to which participants explicitly endorsed the belief that Flemish people are more intelligent than immigrants and with questionnaire measures of subtle and blatant racism. The current study provides a first step toward validating RRT effects as a viable measure of implicit beliefs.
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