Operational changes to the lupus intervention fatigue trial as a result of COVID-19: An update to the study protocol.

Background: The coronavirus disease 2019 (COVID-19) global pandemic drastically impacted the health system and the research community. As a result, research institutions and funding agencies recommended a moratorium on conducting in-person research and study enrollment until protocol changes to protect participant safety were approved and implemented. We detail the operational modifications made to the Lupus Intervention Fatigue Trial (LIFT) protocol and summarize how we met the varied challenges created by COVID-19. Methods: We evaluated study protocols and determined that scheduling, acquiring consent, in-person assessments and intervention baseline visits, patient reported outcomes, and data processing procedures needed modification. Results: Operational modifications were made to ensure study progress while adhering to COVID-19 restrictions. Major changes included electronic consent, remote baseline visits for those in the intervention, self-report outcome measures at home via emailed weblinks, and telemedicine physician assessment visits. The collection of safety labs presented the largest challenge since this required an in-person visit to a laboratory. The study team elected to delay this up to one month after the physician assessment. All follow-up visits were completed, and no participants withdrew from the study. Conclusion: LIFT was severely impacted by COVID-19. We provide insight into how our study protocol was modified without compromising the integrity of the primary and secondary outcomes of the study. The modifications utilized by the LIFT study resulted in efficiencies that will be included in a revised protocol and may serve as a useful example for other behavioral interventions to adapt their research studies.

Estudio comparativo de los niveles de deseabilidad social en adolescentes con y sin trastorno disocial / A comparative study of the levels of social desirability in adolescents with and without a dissocial disorder / Estudi comparatiu dels nivells de desitjabilitat social en adolescents amb i sense trastorn dissocial

En el presente trabajo se ha observado niveles de deseabilidad social significativamente mayores en una muestra de adolescentes sin trastorno disocial respecto otra muestra de jóvenes recluidos con trastorno. Sin embargo, no se han hallado diferencias entre la muestra constituida por adolescentes con trastorno disocial y una muestra de adolescentes escolarizados y en libertad. En la discusión se ofrecen posibles explicaciones a los resultados obtenidos y se realizan sugerencias para futuras investigaciones

In this study we found significantly higher levels of social desirability in a sample of adolescents without dissocial disorder vs. another sample of incarcerated youth with the disorder. However, no differences were found between the sample of adolescents with dissocial disorder and a sample of released adolescent students. In the discussion, possible explanations are offered for these results and suggestions are made for future research. KEY WORDS: adolescents, antisocial disorder, dissocial disorder, social desirability

En el present treball s'han observat nivells de desitjabilitat social significativament majors en una mostra d’adolescents sense trastorn dissocial respecte a una altra mostra de joves reclosos amb trastorn. No obstant això no s'han trobat diferències entre la mostra constituida per adolescents amb trastorn dissocial i la mostra d'adolescents escolaritzats i en llibertat. En la discussió s’ofereixen possibles explicacions als resultats obtinguts i es realitzen suggeriments per a futures investigacions