Frontiers in Pediatrics · 7 authors, 4 centres
This summary was generated by AI from a single paper. It has not been reviewed by a clinician and is not clinical advice. Verify against the source before acting on it.
Only 30.9% of 586 PICU randomized controlled trials reported any social determinant of health (SDOH) variable, with food insecurity (17.1%) and race/ethnicity (12.5%) being most common. Definitions and categories varied widely, and nearly three-quarters of studies had sample sizes ≤100, increasing risk of confounding. Standardized SDOH reporting is needed to improve generalizability and reduce bias in PICU trials.
**Background:** Social determinants of health (SDOH) are known to influence access to care and outcomes for critically ill children, yet their incorporation into pediatric intensive care unit (PICU) research is poorly understood. Randomized controlled trials (RCTs) are considered the gold standard of clinical evidence, and failure to include SDOH variables may lead to confounding, limit generalizability, and hinder meta-analyses. This study aimed to determine the frequency, categories, and definitions of SDOH variables reported in published PICU RCTs.
**Methods:** The authors searched Medline, Embase, Lilacs, and CENTRAL from inception to December 2022 for RCTs of any intervention on children or their families in a PICU. Studies involving only preterm infants or NICU patients, crossover trials, abstracts, protocols, or secondary analyses were excluded. Data were extracted in duplicate on study demographics and nine WHO SDOH categories: income and social protection; early childhood development; parental unemployment and job security; food insecurity; structural conflict; education; social inclusion and non-discrimination; housing, basic amenities, and the environment; and access to affordable health services. Descriptive statistics were generated.
**Key Results:** A total of 586 unique RCTs were included. Studies had a median sample size of 60 patients (IQR 40–106), with 73.0% (428/586) including ≤100 patients and 41.1% (241/586) including ≤50 patients. Most studies (77.3%) were conducted in high- or upper-middle-income countries; none were from low-income countries. Overall, 181 studies (30.9%) reported at least one SDOH variable, and 163 (27.8%) reported them by randomization group. The most frequently reported SDOH category was food insecurity (100/586, 17.1%), followed by social inclusion and non-discrimination (73/586, 12.5%). Among nutrition intervention trials, 25 of 57 (43.9%) reported baseline nutritional assessments; among mechanical ventilation trials, only 11 of 82 (13.4%) did so. Of 41 studies on asthma or bronchiolitis, only 6 (14.6%) reported smoking in the home. Race/ethnicity was reported in 73 RCTs (12.5%), with 61 of those from the United States using 40 different categorization combinations; only 16 studies described how race/ethnicity was determined. Socioeconomic status was mentioned in 10 studies (1.7%), none of which defined how it was measured. Other SDOH categories (e.g., education, unemployment, structural conflict) were reported in fewer than 2% of studies.
**Clinical Implications:** The infrequent and inconsistent reporting of SDOH in PICU RCTs raises concerns about confounding, especially given the small sample sizes of most trials. For example, lack of reporting on household smoking in asthma/bronchiolitis trials (where >80% had ≤100 patients) may bias results. Similarly, baseline nutritional status—a known predictor of outcomes—was missing in most nutrition and ventilation trials. The wide variation in definitions for race/ethnicity and nutritional status limits comparability across studies. The authors call for international consensus on a minimum set of SDOH variables and standardized definitions to improve trial quality, generalizability, and equity in PICU research.