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With the emergence of new tools like physiologically based PK modeling, the decision to conduct an in vivo study can be made with much more confidence. This review provides a comprehensive overview of various factors that need to be considered in designing OC DDI studies and recommends PK-based DDI studies with PK end points as adequate measures to establish clinical drug interaction and measurement of PD end points when there is basis for PD interaction.Maternal opioid use disorder increased > 4-fold from 1999 to 2014 and is associated with poor maternal and fetal outcomes. Women with opioid use disorder are at 2 to 3 times greater risk for unintended pregnancy than the general population and may face additional barriers to accessing and effectively using contraception compared to women without opioid use disorder, particularly highly effective long-acting reversible contraception. Additionally, women with opioid use disorder tend to use less effective forms of contraception such as condoms alone. Barriers to contraceptive access include patient misconceptions or knowledge gaps regarding reproductive health and family planning, cost, intimate partner violence, fear of criminalization, difficulty accessing care, comorbid health conditions, and health care provider misconceptions or practice limitations. Strategies that may assist women with opioid use disorder in achieving their family planning goals include colocation of family planning services within opioid treatment facilities, optimization of patient care services to minimize the need for costly and/or time consuming follow-up, increasing provider education and awareness of best practices in family planning and opioid use disorder treatment, and providing patient-centered family planning education and counseling. Additional research is needed to identify and develop strategies that empower women who use opioids to effectively access and use their preferred contraceptive method.Pregnant women have historically been an understudied population and have been excluded from clinical trials. Recent efforts by stakeholders have raised awareness of the importance of clinical research in pregnant women to inform prescribing decisions. The Food and Drug Administration continues working to improve the format and content of prescription drug labeling for pregnant and lactating women, as demonstrated with the Pregnancy and Lactation Labeling Rule (PLLR), effective in 2015. The pregnancy labeling subsection now includes a subheading dedicated to the inclusion of pharmacokinetic (PK) data that inform the need for dose adjustments during pregnancy and the postpartum period. In addition, the PLLR also requires prescription drug labeling to be updated when important pregnancy information becomes available. Although PLLR improved the presentation of pregnancy-related information in labeling, there is a need to increase the quality and quantity of human data on the use of prescription drugs during pregnancy. PK studies in pregnant women should be incorporated into drug development programs and prioritized to obtain important information about safe and appropriate doses of a drug when used during pregnancy. In addition, opportunistic PK studies, postapproval pregnancy safety studies, ex vivo studies, and in silico modeling can be leveraged to better inform the risks and benefits of using a drug during pregnancy to inform study design and to further understand various mechanisms impacting pharmacokinetic/pharmacodynamic of drugs during pregnancy. It is important to address the significant existing data gaps and better inform the safety and dosing of prescription drugs for pregnant women.
Left-behind children have become a particular concern in mainland China, and unintentional injury among these children has attracted increasing attention. This review aims to present the prevalence of unintentional injury among left-behind children and subgroups in mainland China.
A systematic literature search was conducted using four Chinese and two English databases. The included publications were cross-sectional studies in mainland China, of which the population was recruited according to inclusion and exclusion criteria. Information was collected using self-administered questionnaires. The risk of bias was estimated using the Strengthening the Reporting of Observational Studies in Epidemiology, and pooled prevalence was estimated through the DerSimonian-Laird proportion method.
This review included 34 cross-sectional studies consisting 58,348 left-behind children in mainland China. Results showed that the pooled prevalence of unintentional injury was 38.24% (95% confidence interval (CI) 28.40-48.08irls. Falls had the highest prevalence, and home was the most common occurrence location.
Understanding and addressing contributing factors to unmet dental need is an important public health challenge. This study investigated the prevalence of, and factors associated with, self-reported unmet dental need using a nationally representative sample of US adults.
This was a cross-sectional study using the Medical Expenditures Panel Survey (MEPS) from 2016. The weighted prevalence of unmet dental need was estimated among individuals aged 18years or older. Chi-squared and multivariate logit regression with marginal effects (ie absolute risk differences) were used to measure the association of unmet dental need with respondent characteristics.
The prevalence of adults reporting unmet dental need was 6% (95% CI 5.5 to 6.5). U73122 Adults with dental insurance were 1.7 percentage points (95% CI -2.8 to -0.6) less likely to report unmet dental needs than adults without dental insurance. Those with middle income were 2.3 percentage points (95% CI 1.2 to 3.4), those with low income were 3.3 percentage points (9dress cost and coverage barriers to adult dental care, as these remain significant barriers to access, particularly for low-income adults. Future research should evaluate the reasons adults report unmet dental need and explore how adults' judgment of dental need compares to providers' clinical judgment. Additionally, research that explores how race and ethnicity affect perceptions of unmet dental need is warranted.
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