Capillary Blood Self‐Sampling for Therapeutic Drug Monitoring: A Mixed‐Methods Usability Study of the True Dose® Kit.
Objective: This study evaluates the usability in accordance with EN 62366 of the True Dose kit for capillary blood self‐sampling, to be used to analyze, specify, design, verify, and validate usability as it relates to the safety of medical devices focusing on user performance, experience, and user c...
| Publicado en: | BioMed Research International Vol. 2025; pp. 1 - 10 |
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| Autores principales: | , , , |
| Formato: | pictorial research tables/charts Journal Article |
| Publicado: |
Wiley-Blackwell
7/9/2025
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=186490956&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 186490956 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 23146133 FT2T jtl: BioMed Research International issn: 23146133 maglogo: N pubinfo: dt: 7/9/2025 vid: 2025 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 186490956 186490956 186490956 10.1155/bmri/9973081 186490956 ppf: 1 ppct: 9 formats: fmt: – @attributes: type: T – @attributes: type: C – @attributes: type: P tig: atl: Capillary Blood Self‐Sampling for Therapeutic Drug Monitoring: A Mixed‐Methods Usability Study of the True Dose® Kit. aug: au: Crafoord, Marie-Therése Hedayati, Elham Johnsson, Aina Banerjee, Baisakhi affil: Department of Clinical Science and Education,, Södersjukhuset (South Hospital),, Karolinska Institutet,, Stockholm, Sweden, ki.se sug: subj: Blood Specimen Collection Capillaries Self-Testing Drug Monitoring Reagent Kits, Diagnostic Product Evaluation Life Experiences Confidence Engineering User-Computer Interface Product Development Human Male Female Adult Middle Age Multimethod Studies Usability Study Criterion-Related Validity Quantitative Studies Qualitative Studies Convenience Sample Blood Volume Time Factors Questionnaires Scales Interviews Blood Chemical Analysis Drug Approval Clinical Trials Audiovisuals Funding Source Adult: 19-44 years Middle Aged: 45-64 years Male Female ab: Objective: This study evaluates the usability in accordance with EN 62366 of the True Dose kit for capillary blood self‐sampling, to be used to analyze, specify, design, verify, and validate usability as it relates to the safety of medical devices focusing on user performance, experience, and user confidence through a mixed‐methods approach. The usability engineering process is needed to fulfill user interface design requirements as part of product development at True Dose kit. Methods: The study employed a convergent parallel design, integrating quantitative and qualitative data. Twenty‐five participants, recruited through convenience sampling, used the True Dose kit to perform capillary blood self‐sampling. Quantitative data were collected using three key performance metrics—collection of sufficient blood volume, absence of air bubbles, and duration of the self‐sampling process—along with two questionnaires, the System Usability Scale (SUS) and the Test Feedback Questionnaire (TFQ), to comprehensively assess user performance and experience. In contrast, qualitative data were obtained from interviews and free‐text responses. The integration of findings highlighted areas of convergence and divergence between the quantitative and qualitative data. Results: The overall SUS score was 82.70, indicating high usability. However, participants reported challenges with the complexity of instructions and stress associated with blood flow management. Qualitative insights revealed a preference for simplified visual guidance and highlighted the need for precise feedback mechanisms to ensure the correct execution of sampling steps. Despite these challenges, 92% of participants collected the required blood sample, with a median self‐sampling duration of 10.42 min. Conclusion: The True Dose kit demonstrates high usability potential, but improvements in instructional design and stress management are needed to enhance user experience and ensure consistent performance. Trial Registration: EUCT Number: 2024‐514818‐12‐00 pubtype: Academic Journal doctype: pictorial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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