IntroductionWe incorporated patient feedback from human factors studies (HFS) in the patient-centric design and validation of ava®, an electromechanical device (e-Device) for self-injecting the anti-tumor necrosis factor certolizumab pegol (CZP).MethodsHealthcare professionals, caregivers, healthy volunteers, and patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or Crohn’s disease participated in 11 formative HFS to optimize the e-Device design through intended user feedback; nine studies involved simulated injections. Formative participant questionnaire feedback was collected following e-Device prototype handling. Validation HFS (one EU study and one US study) assessed the safe and effective setup and use of the e-Device using 22 predefined critical tasks. Task outcomes were categorized as “failures” if participants did not succeed within three attempts.ResultsTwo hundred eighty-three participants entered formative (163) and validation (120) HFS; 260 participants performed one or more simulated e-Device self-injections. Design changes following formative HFS included alterations to buttons and the graphical user interface screen. All validation HFS participants completed critical tasks necessary for CZP dose delivery, with minimal critical task failures (12 of 572 critical tasks, 2.1%, in the EU study, and 2 of 5310 critical tasks, less than 0.1%, in the US study).ConclusionCZP e-Device development was guided by intended user feedback through HFS, ensuring the final design addressed patients’ needs. In both validation studies, participants successfully performed all critical tasks, demonstrating safe and effective e-Device self-injections.FundingUCB Pharma.Plain Language SummaryPlain language summary available on the journal website.Electronic supplementary materialThe online version of this article (10.1007/s12325-017-0645-1) contains supplementary material, which is available to authorized users.

Nocardia is an important but often overlooked opportunistic infection agent in immunocompromised hosts. Nocardiosis is primarily pulmonary; central nervous system involvement, usually in the form of brain abscess, is less common. Primary nocardial meningitis without associated brain abscess and pulmonary lesion is extremely rare and poses a formidable diagnostic challenge. We report on a patient with systemic lupus erythematosus who presented with a clinical picture of chronic meningitis which failed to respond to empirical antibiotic treatment. She deteriorated and succumbed. Post-mortem examination showed nocardial meningitis without associated brain abscesses. Nocardial meningitis should be considered a differential diagnosis of subacute meningitis in immunocompromised hosts.