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The article discusses the underrepresentation of pregnant individuals in clinical trials and drug development programs, leading to a lack of safety and efficacy data for this population. It highlights the importance of model‐informed drug development (MIDD) tools and early engagement between pharmaceutical companies and regulatory agencies. The use of physiologically-based pharmacokinetic (PBPK) modeling, toxicology modeling, quantitative systems pharmacology, real-world data, and machine learning are proposed as methods to enhance drug development for pregnant individuals. Efforts to improve inclusivity in clinical trials for pregnant individuals are ongoing, with regulatory agencies emphasizing the need for postmarketing required (PMR) studies to gather essential information. [Extracted from the article]

Background: Families with children diagnosed with ADHD often experience elevated levels of stress compared to families with typically developing children. This stress manifests in various forms including family conflicts, disciplinary challenges, financial strain, parental depression, and difficulties in marital relationships. Objectives: The objective was to assess parenting stress, coping, and resilience among parents of children with ADHD, as well as the psychosocial problems of children with ADHD as reported by parents. Method and Materials: his descriptive cross-sectional study was conducted at the Child Guidance Clinic, Psychiatry Department, Government Medical College & Hospital, Chandigarh. It included 40 consecutive mothers of children diagnosed with ADHD according to DSM-5 criteria, aged 6 to 14 years, fluent in Hindi or English, and residing with their child. Exclusion criteria comprised major medical or psychiatric illnesses, specific learning disabilities (SLD), and comorbid disabilities in children, as well as significant psychiatric or medical illnesses, disabilities, or substance dependencies (excluding nicotine) in mothers, and multiple family members with major disabilities. Assessment tools used were the Socio-demographic and Clinical Data Sheet, Chandigarh Parent Related Stress Scale (CPRSS), Bref-COPE, The Connor-Davidson Resilience Scale (CD-RISC), Screening Tool for Assessment of Psychosocial Problems (STAPP), and Vanderbilt ADHD Diagnostic Parent Rating Scale (VADPRS). Result: The study revealed high levels of stress among mothers of children with ADHD, who employed a range of coping strategies including instrumental support, active coping, and planning, as well as emotional support, acceptance, positive reframing, and religious coping. Some also used maladaptive strategies like behavioural disengagement, venting, and self-blame. Participants showed a moderate level of resilience, with mild overall problems noted. Issues related to financial resources and high expressed emotion were most prevalent, followed by challenges with medication/treatment compliance and social support. Conclusion: This study underscores the need for increased focus on supporting parents in ADHD management, informing the development of comprehensive psychosocial intervention programs. [ABSTRACT FROM AUTHOR]

Introduction: We examined the feasibility and acceptability of digital screening and brief intervention (d‐SBI) for alcohol misuse in college students; the effectiveness of d‐SBI was our secondary outcome. We also explored the barriers and facilitators of d‐SBI. Methods: The study design is a mixed‐methods, pilot, and cluster randomized trial. Five colleges from a northern city in India were randomly allocated to d‐SBI and control groups. One hundred and ninety‐one students were screened, and 25 (male = 23 and female = 2) participants (age 19.62 ± 2.58 years) fulfilled eligibility. All participants completed follow‐up assessments at 3 months. In‐depth interviews were done with 11 participants. Alcohol Use Disorder Identification Test (AUDIT) based screening brief intervention was provided on a web portal‐ or mobile application in the d‐SBI group. The control group received digital screening and brief education. Direct questions and usage statistics assessed the measurement acceptability of the intervention. We compared the change in AUDIT scores in the intervention groups over 3 months post‐intervention. Thematic analyses of transcripts of interviews were done by inductive coding. Results: Most participants reported that d‐SBI was user‐friendly (80%), advice was appropriate (80%), and perceived it to be useful (72%). Ninety‐six percent of users, who logged in, completed screening. There was a significant decrease in AUDIT scores both in d‐SBI (p <.001) and control groups (p <.001). Time and group significantly affected the mean AUDIT score, but time × group interaction was non‐significant. Thematic analysis revealed six overarching themes. Conclusions: Digital SBI for alcohol misuse is acceptable, feasible, and possibly effective among college students from low‐resource settings. [ABSTRACT FROM AUTHOR]

Objective: To development and validation of patient information leaflet (PIL) and assessment of their impact in improving the knowledge of patients with urolithiasis. Methodology: A Quasi-experimental pre and post study design (without a control group) was used to carry out the study in 70 urolithiasis patients. The knowledge assessment questionnaire was prepared with respect to the PILs. The prepared questionnaire was provided to the patients to assess their baseline knowledge before administering the PILs and to assess the knowledge improvement after administering the PILs (Patient was asked to read the PIL for at least 20 minutes). The user opinion of the PIL was also obtained from the patients. Results: The results of the study showed that the post educational user knowledge scores significantly increased from the baseline, i.e., from 44.57% to 88.29% (p 0.000). More than 80% of the patients rated the PILs as good. Conclusion: The current study revealed that the knowledge of the patients improved by 43.7% after administration of the PILs. Thus PILs have been found to be beneficial in enhancing the knowledge of patients with urolithiasis. [ABSTRACT FROM AUTHOR]

Aims Methods Results Conclusions Selective serotonin reuptake inhibitors (SSRIs) are indicated for a variety of psychiatric conditions which may require treatment during pregnancy. Knowledge of appropriate SSRI dosages that maintain maternal therapeutic benefit and minimize fetal risk are needed. Assessment of fetal exposure to drugs is challenging since sampling is often limited to a single concentration from the umbilical cord at delivery. Physiologically based pharmacokinetic (PBPK) modelling provides a non‐invasive approach to quantify exposure in pregnancy.We incorporated sertraline clearances mediated by passive diffusion, placental efflux transporters P‐glycoprotein (P‐gp) and breast cancer resistance protein (BCRP) into our previously published pregnancy PBPK model for sertraline. Simulations were performed for various sertraline doses (25–200 mg) at 40 weeks gestational age to predict the minimum (Cmin), maximum (Cmax) and average (Cavg) sertraline maternal and fetal plasma concentrations and evaluated them against observed maternal and cord concentrations obtained at delivery from five clinical studies.The accuracy of the PBPK predictions as indicated by the average fold error (AFE) value for Cmax, Cmin and Cavg for maternal plasma sertraline concentrations at delivery was 1.7, 1.2 and 1.4, respectively. The AFE for the Cmax, Cmin and Cavg for cord blood sertraline concentration at delivery was 1.2, 1 and 1.1, respectively. The AFE for cord‐maternal sertraline concentration ratio at delivery for Cmax, Cmin and Cavg was 0.7, 0.9 and 0.8, respectively.The PBPK model we developed may serve as a guide for maternal sertraline dose adjustment during pregnancy considering changes in exposures for both mother and fetus. [ABSTRACT FROM AUTHOR]

Background: Alcohol misuse is prevalent among college students globally, including in India. Digital screening and brief interventions (DSBI) promise to address this issue. This study assesses DSBI's effectiveness in a state-wide cluster randomized trial among college students in India., Methods: We recruited 548 participants (274 in each DSBI and digital screening and brief advice-DSBA) from 40 colleges across 10 districts of Punjab, India. Colleges were selected via two-stage cluster random sampling and were allocated to groups using permuted block randomization. Participants with Alcohol Use Disorder Identification Test (AUDIT) scores between 8 and 19 were included. The digital platform directed eligible participants to their respective groups. DSBI participants received information on alcohol harms, normative and personalized feedback, a decisional balance checklist, and a menu of options. DSBA participants received screening and alcohol harm information. Follow-ups were conducted at 3- and 6-month post-intervention., Primary Outcome: reduction in AUDIT scores; secondary outcomes: frequency of drinking, drinks per drinking day, and frequency of heavy episodic drinking (HED)., Results: Baseline demographics and clinical variables did not significantly differ between groups, except for participants' age. 37.6% were women. Follow-up rates were 513/548 at 3 months and 483/548 at 6 months, with no group differences in attrition. AUDIT scores significantly decreased in both groups at 3 and 6 months (Time F = 1870.11, p < 0.001, partial η 2 = 0.77), with no Group × Time effects (F = 0.160, p = 0.85). Drinking frequency, HED frequency, and drinks per drinking day decreased significantly in both groups without between-group differences., Conclusion: The study highlights the potential policy implications of integrating brief digital interventions for alcohol misuse into educational health initiatives., (© 2024 Research Society on Alcohol.)

Background and Objectives: Substance use among young college students in India poses public health challenges. This study seeks to uncover the motivation behind alcohol and illicit drug consumption, applying social norms theory., Methods: This qualitative research utilized the framework method to analyze data from 14 college students (18-24 years) across various disciplines. Participants were selected using purposive sampling to ensure diversity in demographics and perspectives. Data collection was conducted online. The study used a combination of in-depth interviews (n = 14) and focused group discussions (n = 2). We used AtLAS.ti to facilitate data analysis. We used a mixed inductive and deductive coding approach. A mind map was generated to visualize the complex interplay between social norms and other individual and external mediators., Results: We identified 10 themes, 20 subthemes, and 42 codes. The themes revealed descriptive (e.g., media and modernization) and injunctive (e.g., availability and legality) social norms that facilitate substance use and social disapproval and stigma that might deter young people from using substances. Family and institutional support were also found to play a protective role. The individuals also weigh the personal consequences (e.g., health and academic harm) and advantages (e.g., coping and relaxation) of substance use, which can influence their decision to use substances. Gendered norms and subtle differences in the social norms between alcohol and illicit drugs were also identified., Conclusion: Our study illuminates culturally tailored substance use prevention/intervention strategies that operate at the social, individual, and policy levels., Competing Interests: The authors declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article., (© 2024 The Author(s).)

The success of cisplatin-containing regimens to treat solid tumors is limited, in part, by nephrotoxicity. In rodents, several urinary proteins have emerged that are sensitive indicators of cisplatin-induced kidney injury. We sought to characterize time-dependent changes in the urinary concentrations of 12 proteins, including kidney injury molecule-1 (KIM-1), calbindin, beta 2-microglobulin (β2M), and trefoil factor 3 (TFF3) after cisplatin therapy. Urine was collected at baseline, 3 days (range, 2-5 days), and 10 days (range, 9-11 days) from 57 patients with solid tumors receiving outpatient cisplatin therapy (≥25 mg/m 2 ). Serum creatinine was largely unchanged after cisplatin infusion. However, compared with baseline values, several novel biomarkers were significantly increased in the urine, including β2M, which was threefold higher by day 3 (P < 0.0001). Urinary KIM-1 and TFF3 were elevated twofold by day 10 (P = 0.002 and P = 0.002, respectively), whereas calbindin levels were increased eightfold (P < 0.0001). We report novel time-dependent changes in the urinary excretion of noninvasive markers of subclinical kidney injury after cisplatin treatment., (© 2016 American Society for Clinical Pharmacology and Therapeutics.)