ObjectiveThis study assessed patient experiences of using an autoinjector device to self-administer subcutaneous belimumab for the treatment of systemic lupus erythematosus (SLE). Satisfaction, ease and convenience of use, and confidence with the device were assessed, in addition to overall experience with belimumab.MethodsThis cross-sectional study was conducted among patients who completed a phase IIb open-label, multi-dose usability, tolerability, and safety study of subcutaneous belimumab (NCT02124798), in which patients receiving intravenous belimumab or subcutaneous belimumab using a prefilled syringe were switched to eight weekly self-administered doses of subcutaneous belimumab using the autoinjector. This follow-up study comprised an online/paper questionnaire and qualitative telephone interviews.ResultsIn total, 43 patients receiving belimumab completed the questionnaire, 21 of whom also completed a follow-up telephone interview. Qualitative interviews indicated that 17 of 21 (81%) patients had a positive experience using the autoinjector; all patients considered the autoinjector to be convenient. Of the 42 patients who switched from intravenous belimumab to the autoinjector, 32 (76%) expressed a preference for the autoinjector over intravenous administration; reasons included convenience, time saved, cost, and reduced injection pain. The most commonly reported disadvantage of the autoinjector was injection discomfort (n = 5 [24%]; qualitative interview). Compared with intravenous administration, the autoinjector improved ability to work (17 of 29 [59%] of those employed) and carry out daily activities (40%).ConclusionPatients with SLE reported high levels of satisfaction with the belimumab autoinjector and preferred the autoinjector to intravenous administration, citing advantages such as time saved, cost, and improved ability to work and carry out daily activities.Electronic supplementary materialThe online version of this article (doi:10.1007/s40271-017-0276-2) contains supplementary material, which is available to authorized users.
The present study examined behavioral correlates of peer exclusion and victimization among sixth-grade European and East Asian American young adolescents, with an emphasis on aggressive and socially withdrawn behaviors. Concurrent and short-term longitudinal (over 1 academic year) associations between behavior and the distinct forms of peer adversity (victimization/exclusion) were assessed. Results varied by gender and ethnicity and suggested that social withdrawal was associated with exclusion, whereas aggression was associated with victimization. Interactions between gender and aggression predicted peer victimization after controlling for prior victimization. Extremely aggressive girls were more likely to be victimized than nonaggressive girls. Interactions between gender, ethnicity, and behavior predicted exclusion, controlling for prior exclusion. Extremely withdrawn European American girls were less excluded than nonwithdrawn European American girls. Universals emerged in the prediction of exclusion from withdrawal for all other groups and from aggression for all four groups. These results highlight the importance of considering ethnicity and gender in the links between different behaviors and the distinct forms of peer adversity.
This paper offers a framework for understanding, planning, and implementing methods to advance PE in the selection and/or development of COAs for evaluating the benefit of medical products. The intent is to further this important discussion and enhance the process and outcome of PE in this context.
The current study examined how racial and sociobehavioral similarities were associated with friendship stability and friendship quality. Cross-race friends were not significantly similar to each other in peer-nominated shyness/ withdrawal, victimization, exclusion, and popularity/sociability. Relative to same-race friends, cross-race friends were significantly less similar in peernominated popularity/sociability, exclusion, and victimization. Although same-race friendships were more prevalent than cross-race friendships, only similarity in friends' aggressive behavior (but not racial homophily) was related to friendship stability. Neither racial nor sociobehavioral similarity predicted friendship quality beyond adolescents' individual sociobehavioral characteristics. Taken together, findings suggest that although racial similarity may affect initial friendship formation, racial similarity may not impact friendship
The final 28-item HIS-Q is reliable, valid, and responsive. The HIS-Q is suitable for inclusion in future clinical trials to help characterize the effects of testosterone replacement therapy.
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