Use of administrative claims data in observational studies of antirheumatic medication effects on pregnancy outcomes: a scoping review protocol.

OBJECTIVE: The primary objective of this review is to examine which disease-modifying antirheumatic drugs (DMARDs) and biologics used to treat pregnant individuals with rheumatic conditions have been reported in observational studies using population-based health administrative data. The secondary objective is to describe which adverse pregnancy outcomes (both maternal and neonatal) have been reported, their definitions, and corresponding diagnostic and/or procedural codes. INTRODUCTION: Pregnant individuals are typically excluded from drug trials due to unknown potential risks to both the pregnant person and fetus, leaving most antirheumatic drugs understudied for use in pregnancy. Despite these substantial knowledge gaps, most pregnant individuals continue to be maintained on antirheumatic medications due to the benefits generally outweighing the risks. In contrast to previous systematic reviews of findings from randomized trials, our scoping review aims to leverage this real-world data to generate real-world evidence of antirheumatic drug safety during pregnancy. INCLUSION CRITERIA: Articles must report on observational studies using population-based health administrative data from pregnant individuals with rheumatic conditions (rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, and psoriatic arthritis) receiving antirheumatic drug therapy (DMARDs and biologics). Randomized trials, reviews, case studies, opinion pieces, and abstracts will be excluded. METHODS: Electronic databases (MEDLINE [Ovid], Embase [Ovid], CINAHL [EBSCOhost]) and gray literature (OpenGrey, Health Services Research Projects in Progress, World Health Organization Library, and Google Scholar) will be searched for relevant evidence. Search terms will combine 4 concepts: rheumatic diseases, drug therapy, pregnancy, and health care administrative data. Identified articles will be independently screened, selected, and extracted by 2 researchers. Data will be analyzed descriptively and presented in tables. REVIEW REGISTRATION: Open Science Framework https://osf.io/5e6tp.

Global trends in antidepressant, atypical antipsychotic, and benzodiazepine use: A cross-sectional analysis of 64 countries.

OBJECTIVE: To describe the trends in use of antidepressants (ADs), atypical antipsychotics (AAPs), and benzodiazepines (BZDs) among high-, middle-, and low-income countries. METHODS: A cross-sectional time-series analysis by country from July 2014 to December 2019 utilizing IQVIA's Multinational Integrated Data Analysis database was conducted. Population-controlled rates of use were calculated in number of standard units of medications per drug class per population size. The United Nations' 2020 World Economic Situation and Prospects was used to group countries into high-, middle-, and low-income. Percent change in rates of use per drug class was calculated from July 2014 to July 2019. Linear regression analyses were conducted to assess the predictability of percent change in use utilizing a country's baseline rate of use per drug class and economic status as predictor variables. RESULTS: A total of 64 countries were included: 33 high-, 6 middle-, and 25 low-income. Average baseline rates of use for ADs in high-, middle-, and low-income countries were 2.15, 0.35, and 0.38 standard units per population size, respectively. For AAPs, rates were 0.69, 0.15, and 0.13, respectively. For BZDs, rates were 1.66, 1.46, and 0.33, respectively. Average percent changes in use for ADs by economic status were 20%, 69%, and 42%, respectively. For AAPs, they were 27%, 78%, and 69%, respectively. For BZDs, they were -13%, 4%, and -5%, respectively. Some associations were found demonstrating that as a country's economic status increases, percent change of AD (p = 0.916), AAP (p = 0.23), and BZD (p = 0.027) use decreases. Similarly, as baseline rate of use for ADs and AAPs increases, percent change in use decreases with p-values of 0.026 and 0.054, respectively. For BZDs, as baseline rate of use increases, percent change in use increases (p = 0.038). CONCLUSIONS: High-income countries have a higher rate of treatment utilization compared to low- and middle-income countries (LMICs) with treatment utilization increasing in all countries of interest.

Letting kids play their CARDs (Comfort, Ask, Relax, Distract) to help cope with needle-related fear and pain: Results from user testing.

This study examined perceptions of children and parents about a new web-based CARD (Comfort, Ask, Relax, Distract) game that teaches children how to cope with needle-related pain and fear. A convenience sample of 15 child-parent dyads (children, 6-12 years) participated. Children played the game on a handheld device while being virtually monitored. Activity tracking revealed most children engaged with multiple components. Children reported they understood the game, it was easy to play, they learned coping strategies and believed they could implement them. Children reported lower fear of needles after playing. Parents liked the simplicity and variety of game activities. Most children and parents reported they would use the game or its coping strategies for future needles and would recommend the game. In summary, children and parents found the CARD web game acceptable and appropriate. Future studies can evaluate its effectiveness when integrated into upcoming needle procedures like COVID-19 vaccinations.

Abnormal Bone Acquisition With Early-Life HIV Infection: Role of Immune Activation and Senescent Osteogenic Precursors.

Chronic immune activation associated with human immunodeficiency virus (HIV) infection may have negative consequences on bone acquisition in individuals infected with HIV early in life. Bone mineral density (BMD) and microarchitecture were characterized in 38 HIV-infected men on antiretroviral therapy (18 perinatally-infected, 20 adolescence-infected) and 20 uninfected men age 20 to 25 years by dual-energy X-ray absorptiometry (DXA), high-resolution peripheral quantitative computed tomography (HRpQCT). Flow cytometry was utilized to measure CD4+/CD8+ activation (HLADR+CD38+) and senescence (CD28-CD57+) and to quantify circulating osteogenic precursor (COP) cells in peripheral blood mononuclear cells using antibodies to RUNX2 and osteocalcin (OCN). Telomere lengths were measured in sorted COP cells using qPCR. DXA-derived areal BMD Z-scores and HRpQCT-derived volumetric BMD (vBMD) measures were lower in HIV-infected than uninfected men. Proportion of activated and senescent CD4+ and CD8+ T cells were higher in HIV-infected than uninfected men. The percentage of COP cells (mean ± SE) was lower in HIV-infected than uninfected (0.19% ± 0.02% versus 0.43% ± 0.06%; p < 0.0001) men, and also lower in perinatally-infected than adolescence-infected men (0.15% ± 0.02% versus 0.22% ± 0.03%; p < 0.04). A higher proportion of COP cells correlated with higher bone stiffness, a measure of bone strength, whereas a higher proportion of activated CD4+ T cells correlated with lower BMD and stiffness and lower proportion of COP cells. T cell activation with HIV-infection was associated with decreased numbers of osteogenic precursors as well as lower peak bone mass and bone strength. © 2016 American Society for Bone and Mineral Research.