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Context: A growing body of evidence supports over‐the‐counter access to oral contraceptives in the United States. An important consideration for over‐the‐counter approval is consumers' ability to understand key package label messages related to safety and effectiveness without clinician involvement. We developed a prototype over‐the‐counter Drug Facts Label for a combined oral contraceptive pill and conducted a pilot label comprehension study to evaluate consumer understanding of key messages for use. Methods: In November–December 2020, we conducted interviews with 163 adults and teens in the United States who were aged 12–49 years and identified as female or another gender but had a uterus and the ability to become pregnant. We developed 11 primary endpoints based on assessment of clinical risks that could occur if consumers fail to heed them, including messages about contraindications and directions for use; 11 secondary endpoints represented additional important information but with lower potential for clinical consequences if not understood. We evaluated endpoint comprehension by computing frequencies, percentages, and 2‐sided Exact (Clopper‐Pearson) 95% confidence intervals for observed proportions. Results: Ten of the 11 primary endpoints and 10 of the 11 secondary endpoints were each understood by ≥95% of participants. The remaining primary endpoint on use with prior blood clots was understood by 89% of participants. The remaining secondary endpoint on the product being designed for "people who have the ability to become pregnant" was understood by 83% of participants. Conclusion: Participants understood the key label information required for safe and effective combined oral contraceptive use without clinician involvement. [ABSTRACT FROM AUTHOR]

Objective: Life‐threatening thoracic trauma requires emergency pleural decompression and thoracostomy and chest drain insertion are core trauma procedures. Reliably determining a safe site for pleural decompression in children can be challenging. We assessed whether the Mid‐Arm Point (MAP) technique, a procedural aid proposed for use with injured adults, would also identify a safe site for pleural decompression in children. Methods: Children (0–18 years) attending four EDs were prospectively recruited. The MAP technique was performed, and chest wall skin marked bilaterally at the level of the MAP; no pleural decompression was performed. Radio‐opaque markers were placed over the MAP‐determined skin marks and corresponding intercostal space (ICS) reported using chest X‐ray. Results: A total of 392 children participated, and 712 markers sited using the MAP technique were analysed. Eighty‐three percentage of markers were sited within the 'safe zone' for pleural decompression (4th to 6th ICSs). When sited outside the 'safe zone', MAP‐determined markers were typically too caudal. However, if the site for pleural decompression was transposed one ICS cranially in children ≥4 years, the MAP technique performance improved significantly with 91% within the 'safe zone'. Conclusions: The MAP technique reliably determines a safe site for pleural decompression in children, albeit with an age‐based adjustment, the Mid‐Arm Point in PAEDiatrics (MAPPAED) rule: 'in children aged ≥4 years, use the MAP and go up one ICS to hit the safe zone. In children <4 years, use the MAP.' When together with this rule, the MAP technique will identify a site within the 'safe zone' in 9 out of 10 children. [ABSTRACT FROM AUTHOR]