Is America’s president building his own paramilitary militia?

Background The PIONIR (Preventing IBD ONset in Individuals at Risk) trial evaluates whether the Tasty&Healthy diet can reduce risk of Crohn’s disease (CD) development in first-degree relatives (FDRs). The optimal preclinical stage of CD for enrolling subjects to prevention trials is unknown. Objectives We aimed to propose a framework for identifying high-risk participants for prevention trials by reporting the outcomes of the pre-PIONIR screening stage. Design Faecal calprotectin was measured in asymptomatic FDRs aged 6–38 years; those with persistent elevation, defined as >70 µg/g in at least two separate tests, were offered panenteric video capsule-endoscopy or ileocolonoscopy. Results Of 950 FDRs approached, 331 (35%) agreed to be screened: 63 (19%) had persistently elevated calprotectin, of whom 42 underwent further evaluation. Nine (2.7%) had endoscopic appearance compatible with presymptomatic CD, 22 (6.6%) had non-specific macroscopic mucosal changes and 11 (3.3%) had normal mucosa despite elevated calprotectin, suggesting probable histological inflammation. The 33 participants in the two latter groups were defined as ‘potential pre-CD’ (17.9% of all screened after adjusting for missing values). Calprotectin >225 µg/g predicted presymptomatic CD (area under the receiver operating characteristic curve 0.97 (95% CI 0.94 to 1.0; p<0.001; sensitivity 89%, specificity 94%). Of those with a single elevated calprotectin value, 22% normalised on repeat testing with significant variability (intraclass correlation coefficient 0.72 (95% CI 0.57 to 0.82)). Conclusion Approximately one in five asymptomatic FDRs had persistently elevated calprotectin, which was able to differentiate those with presymptomatic CD. The findings highlight calprotectin’s utility in identifying at-risk individuals during the potential pre-CD stage for enrolment in prevention trials. Data are available upon reasonable request. Data are available on reasonable request to the corresponding author.

Advocates and lawmakers are calling for the reinstatement of an independent oversight body to investigate and help prevent deaths, as well as changes to medical and geriatric parole.

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