2019 · Clinical pharmacology and therapeutics · open access
Leveraging Digital Health Technologies and Outpatient Sampling in Clinical Drug Development: A Phase I Exploratory Study
Dockendorf et al.
The finding, in our words
In a fixed-sequence two-period Phase I study of 16 healthy volunteers taking sitagliptin, dried blood spot samples collected at home and digital adherence data captured via an electronic pill bottle were feasible and acceptable to participants. This supports patient-centric microsampling and remote monitoring for decentralised clinical trials, though the authors noted areas needing improvement.
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.
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 ↗
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 ↗
The study determined that using self-collected dried blood spots alongside online surveys was a feasible and acceptable method for remote pre-exposure prophylaxis adherence monitoring, with 64% of participants returning at least one blood specimen.
Jones et al., Current psychology (paywalled) · source ↗
A study of older rural US patients found that 96 to 98 per cent of self-collected dried blood spot specimens were successfully analysed for HIV viral load, with high acceptability. However, concordance between self-reported and measured viral load was only 69 to 82 per cent, highlighting the value of objective decentralised microsampling over self-reporting.
Walsh et al., AIDS and behavior (paywalled) · source ↗