Female adolescents' perceptions of male partners' pregnancy desire

Our objective was to examine the relationship between pregnancy desire among female adolescents and their perception of desire for pregnancy in their male partners. This is an observational cross-sectional study which examined 92 surveys administered to adolescent women between the ages of 14 to 19 years at two obstetrical care services serving a population from limited socioeconomic backgrounds. Participants were all pregnant or awaiting pregnancy test results. Participants were asked about their levels of pregnancy happiness and desire and their partners' levels of pregnancy happiness and desire. Spearman's correlation coefficient was calculated and discordant pairs were examined with McNemar's test. Logistic regression was utilized to examine the relationship between male and female pregnancy happiness and desire. We found that there was a significant correlation between the adolescents' feelings about pregnancy and their perceptions of their male partners' feelings about pregnancy (0.326; P = .004). McNemar's test indicated that male partners were significantly more likely to be reported to feel positively about the pregnancy than female partners (P = .017). Female adolescents who reported male partners who felt positively about the pregnancy were four times as likely to report having desired their pregnancy now or sooner (odds ratio [OR] = 4.35). We conclude that male partners may impact adolescent pregnancy desire. Further prospective studies are needed and male-focused adolescent pregnancy interventions should be developed.     

Knowledge and decision-making for labour analgesia of Australian primiparous women

OBJECTIVE: to assess and investigate knowledge of labour pain management options and decision-making among primiparous women. DESIGN: a semi-structured guide was used in focus groups to gather pregnant women's knowledge concerning labour analgesia. Attitudes to labour and pain relief, knowledge of pain relief, trustworthiness of knowledge sources, and plans and expectations for labour pain relief were investigated. SETTING: a major tertiary obstetric hospital in metropolitan Sydney, Australia. PARTICIPANTS: twenty five primiparous women, who were 25 weeks or more gestation, and planning a vaginal birth. FINDINGS: although women considered themselves knowledgeable, they were unable to describe labour analgesic risks or benefits. There was a large discrepancy between perception and actual knowledge. The main source of knowledge was anecdotal information. Late in pregnancy was considered the ideal time to be given information about labour analgesia. Women described their labour pain relief plans as flexible in relation to their labour circumstances; however, most women wanted to take an active role in decision-making. KEY CONCLUSIONS: the large discrepancy between perceived knowledge and actual knowledge of the likely consequences of labour analgesia suggests that women rely too heavily on anecdotal information. IMPLICATIONS FOR PRACTICE: clinicians should be aware that some women overestimate their knowledge and understanding of analgesic options, which is often based on anecdotal information. Standardised labour analgesia information at an appropriate time in their pregnancy may benefit some women and assist health-care providers and women to practice shared decision-making.     

Strategic,feasibility, economic,and cultural aspects of phase 0 approaches: Is it time to change the drug development process in order to increase productivity?

Research conducted over the past 2 decades has enhanced the validity and expanded the applications of microdosing and other phase 0 approaches in drug development. Phase 0 approaches can accelerate drug development timelines and reduce attrition in clinical development by increasing the quality of candidates entering clinical development and by reducing the time to “go‐no‐go” decisions. This can be done by adding clinical trial data (both healthy volunteers and patients) to preclinical candidate selection, and by applying methodological and operational advantages that phase 0 have over traditional approaches. The main feature of phase 0 approaches is the limited, subtherapeutic exposure to the test article. This means a reduced risk to research volunteers, and reduced regulatory requirements, timelines, and costs of first‐in‐human (FIH) testing. Whereas many operational aspects of phase 0 approaches are similar to those of other early phase clinical development programs, they have some unique strategic, regulatory, ethical, feasibility, economic, and cultural aspects. Here, we provide a guidance to these operational aspects and include case studies to highlight their potential impact in a range of clinical development scenarios.     

FDA Approval Summary: Ruxolitinib for Treatment of Chronic Graft-Versus-Host Disease after Failure of One or Two Lines of Systemic Therapy

On September 22, 2021, the Food and Drug Administration approved ruxolitinib for the treatment of chronic graft-versus-host disease (cGVHD) after the failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. Approval was based on Study INCB 18424-365 (REACH-3; CINC424D2301; {"type":"clinical-trial","attrs":{"text":"NCT03112603","term_id":"NCT03112603"}}NCT03112603), a randomized, open-label, multicenter trial of ruxolitinib in comparison to best available therapy (BAT) for the treatment of corticosteroid-refractory cGVHD occurring after the allogeneic hematopoietic stem cell transplantation. A total of 329 patients were randomized 1:1 to receive either ruxolitinib 10 mg twice daily (n = 165) or BAT (n = 164). BAT was selected by the investigator prior to randomization. The overall response rate through Cycle 7 Day 1 was 70% (95% CI, 63-77) in the ruxolitinib arm, and 57% (95% CI, 49-65) in the BAT arm. The median duration of response, calculated from first response to progression, death, or initiation of new systemic therapies for cGVHD, was 4.2 months (95% CI, 3.2-6.7) for the ruxolitinib arm and 2.1 months (95% CI, 1.6-3.2) for the BAT arm; and the median time from first response to death or initiation of new systemic therapies for cGVHD was 25 months (95% CI, 16.8-not estimable) for the ruxolitinib arm and 5.6 months (95% CI, 4.1-7.8) for the BAT arm. Common adverse reactions included anemia, thrombocytopenia, and infections. Given the observed response rate with durability, the clinical benefit of ruxolitinib appears to outweigh the risks of treatment for cGVHD after the failure of one or two lines of systemic therapy.     

Impact of Parent-Provided Distraction on Child Responses to an IV Insertion

This study evaluates the impact of parent-provided distraction on children's responses (behavioral, physiological, parent, and self-report) during an IV insertion. Participants were 542 children, 4 to 10 years old, randomized to an experimental group that received a parent distraction coaching intervention or to routine care. Experimental group children had significantly less cortisol responsivity (p = .026). Children that received the highest level of distraction coaching had the lowest distress on behavioral, parent report, and cortisol measures. When parents provide a higher frequency and quality of distraction, children have lower distress responses on most measures.     

Clarifying Relations Between Thought-Action Fusion, Religiosity, and Obsessive–Compulsive Symptoms Through Consideration of Intent

Conflicting findings regarding the relations between thought-action fusion (TAF), religiosity, and obsessive compulsive disorder (OCD) may be due to a lack of clarity regarding the intent associated with the negative thoughts under consideration. In Study 1, we examined the perceptions of the immorality of intentional and unwanted morally-relevant thoughts (Moral TAF) and their relations with OCD symptoms, religiosity, and obsessive beliefs in a non-clinical sample. In Study 2, we randomly assigned participants to complete one of two versions of a previously used sentence neutralization task that was varied in terms of intent. Perception of the immorality of intentional negative thoughts but not unwanted negative thoughts was associated with Protestant/Catholic affiliation and greater prayer frequency, and perception of the immorality of unwanted thoughts was consistently associated with obsessive beliefs. Neither form of Moral TAF was associated with OCD symptoms. Further, reaction to the modified non-intentional neutralization task was associated with OCD symptoms, thought-action fusion, and scrupulosity, while reaction to the original intentional task was only associated with Moral TAF. Overall, the findings suggest that individuals differ in their perceptions of intentional versus unintentional thoughts. Perceptions of intentional morally-relevant thoughts appear related to religiosity, while perceptions of unintentional thoughts are likely to be of greater relevance to our understanding of OCD.