2024 · Clinical and translational science · open access
Safety of BI 1358894 in patients with major depressive disorder: Results and learnings from a phase II randomized decentralized clinical trial
Reist et al.
The finding, in our words
A fully remote phase II trial in major depressive disorder was terminated early due to poor recruitment but demonstrated feasibility with a 97.7% completion rate and 88% positive patient experience, highlighting the need to optimise eligibility criteria and recruitment strategies for future decentralised interventional studies.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
The study found that although participants preferred patient-centric microsampling devices for home use, the agreement with venous plasma for measuring CRP and cytokines was inconsistent, indicating that further validation is required before these methods replace standard venipuncture.
The study determined that an at-home saliva collection protocol using the passive drool method was feasible for Black women with histories of abuse, with 84% of participants completing at least one full day of adherent sampling. While the decentralised approach yielded usable cortisol data, women with histories of forced sex exposure showed lower protocol adherence scores.
Tsuyuki et al., Interactive journal of medical research (paywalled) · source ↗
In a pilot mixed-methods study of youth with HIV, mailed HemaSpot-HF kits enabled home-based dried blood spot collection that participants found feasible and acceptable, supporting remote viral load monitoring and a self-management model for decentralised care.
Gurung et al., AIDS and behavior (paywalled) · source ↗
In a feasibility randomised controlled trial with 28 adults aged 65 years, 62% successfully self-collected finger-prick capillary blood samples for influenza antibody and vitamin D measurement. While overall study procedures were acceptable, the capillary sampling method requires refinement before wider deployment in decentralised diagnostics for older adults.
Royal et al., Pilot and feasibility studies (paywalled) · source ↗
This study demonstrated that a fully remote genome sequencing study using self-collected dried blood spots and buccal swabs is feasible for individuals with Prader-Willi syndrome, with all participants completing the study and reporting the process was easy despite being lengthy. The design successfully returned actionable genetic findings, including those related to blood clot formation, to participants.
Vrana-Diaz et al., Genetics in medicine open · source ↗