Statistics
Study-wide overview of enrolled participants and blood sample collections.
Participants
Enrollment, parts, adverse events and completion
Blood samples collected
Sample volume and collection type split
Protocol Endpoints
Endpoint values captured across participants, cohorts, and clinical sites.
Part A — Secondary & exploratory endpoints
Scientific evaluation study. Tap the ? icon for the full definition of each endpoint.
- Secondary
To evaluate the ability to collect samples at the study site with a PCmS approach that meets laboratory quality criteria.
% of staff-collected samples from the PCmS approach fulfilling expected laboratory quality criteria (e.g. volume, time frame for shipping/receiving, haemolysis/clotting, and suitability for analysis).
10%4 of 40 staff-collected samples meet quality criteria - Secondary
To confirm that samples are collected correctly at the study sites across demographic groups (examples include differences between age groups, sex, and different disease populations).
Concentrations of the chosen analytes in venous blood and in capillary blood collected with the PCmS approach, across demographic groups.
69samples across 6 cohorts · 2 sexes - Secondary
To gather user feedback on sampling methods in participants across demographic groups (examples include differences between age groups, sex, and different disease populations).
PCmS approach usability questionnaire responses.
60%24 of 40 questionnaires completed - Exploratory
To confirm the PCmS approach can be applied without unexpected issues.
Incidence (number of) and severity of adverse events related to the PCmS approach and venipuncture collection among all participants.
7adverse events (2 severe) across 33 Part A participants
Part B — Secondary & exploratory endpoints
Real-world feasibility study. Tap the ? icon for the full definition of each endpoint.
- Secondary
To assess participant acceptability, usability of the PCmS approach, and feasibility of self-collection.
PCmS approach usability questionnaire responses.
52%26 of 50 questionnaires completed - Secondary
To evaluate the adequacy of methods of training and instructions for the PCmS approach.
Percentage of participants requiring assistance or reporting difficulty with handling the PCmS approach on their own.
59%46 of 78 required assistance or reported difficulty - Exploratory
To assess feasibility of using a laboratory across EU countries in the analysis of samples collected with PCmS approach.
% of self-collected samples fulfilling expected laboratories quality criteria (e.g. volume, time frame and suitability for analysis) across EU countries.
5%1 of 22 self-collected samples meet quality criteria across 6 countries - Exploratory
Confirm the PCmS approach can be applied without unexpected issues.
Incidence (number of) and severity of adverse events related to the PCmS approach among all participants.
10adverse events (4 severe) across 36 Part B participants
Breakdown per study cohort
All metrics above split by cohort
| Cohort | Participants | Part A | Part B | Part A + B | Adverse events | % completed | Samples | Venous | Capillary | % accurate |
|---|---|---|---|---|---|---|---|---|---|---|
| Elderly | 12 | 5 | 3 | 4 | 12 | 83% | 28 | 15 | 13 | 96% |
| Cardiovascular disease | 9 | 5 | 3 | 1 | 9 | 100% | 21 | 11 | 10 | 76% |
| Colorectal cancer | 7 | 1 | 1 | 5 | 7 | 86% | 28 | 14 | 14 | 96% |
| Breast cancer | 6 | 2 | 3 | 1 | 6 | 100% | 17 | 9 | 8 | 94% |
| Prostate cancer | 6 | 1 | 2 | 3 | 6 | 83% | 17 | 6 | 11 | 82% |
| Pediatrics | 10 | 0 | 5 | 5 | 10 | 90% | 36 | 20 | 16 | 94% |
| Overall | 50 | 14 | 17 | 19 | 50 | 90% | 147 | 75 | 72 | 91% |
Usability Questionnaire
Aggregated participant feedback on usability, clarity, and overall experience.
Questionnaire answers summary
Aggregated responses across all 50 participant surveys (Complete: 39 · Incomplete: 8 · Not started: 3). Multi-select answers are counted per option.
A. Previous Experience with Microsampling
| Q # | Question | Answer breakdown | Answered | Not answered |
|---|---|---|---|---|
| A1 | Had you heard about blood microsampling before this study? |
| 45(90%) | 5 |
| A2 | Name of the microsampling device previously known | Free-text — 11 responses | 11(22%) | 39 |
| A3 | Number of previous uses |
| 21(42%) | 29 |
| A4 | Ease of previous use |
| 13(26%) | 37 |
| A5 | Previous difficulties experienced | Free-text — 22 responses | 22(44%) | 28 |
B. Study Information and Visit Experience
| Q # | Question | Answer breakdown | Answered | Not answered |
|---|---|---|---|---|
| B1 | Study information was easy to understand |
| 42(84%) | 8 |
| B2 | I felt comfortable asking questions about the study |
| 46(92%) | 4 |
| B3 | Satisfaction with study visit organisation |
| 46(92%) | 4 |
| B4 | Convenience of visit scheduling |
| 41(82%) | 9 |
| B5 | Study staff treated me respectfully |
| 44(88%) | 6 |
| B6 | I felt comfortable asking questions during the visit |
| 42(84%) | 8 |
| B7 | Satisfaction with answers received |
| 42(84%) | 8 |
| B8 | Visit duration was acceptable |
| 43(86%) | 7 |
| B9 | Impact on daily life was acceptable |
| 43(86%) | 7 |
| B10 | I felt comfortable providing feedback on sampling preferences |
| 41(82%) | 9 |
C. Conventional Sampling vs Microsampling Experience
| Q # | Question | Answer breakdown | Answered | Not answered |
|---|---|---|---|---|
| C1 | Pain rating for conventional venous blood sampling (0-10) |
| 43(86%) | 7 |
| C2 | Pain rating for microsampling device collection (0-10) |
| 44(88%) | 6 |
| C3 | Preferred blood collection method if given a choice |
| 45(90%) | 5 |
| C4 | Why did you choose this preferred method? | Free-text — 43 responses | 43(86%) | 7 |
D. Microsampling Device Experience
| Q # | Question | Answer breakdown | Answered | Not answered |
|---|---|---|---|---|
| D1 | The device seemed easy to use |
| 45(90%) | 5 |
| D2 | The device caused little or no pain |
| 47(94%) | 3 |
| D3 | I could use the device at home |
| 44(88%) | 6 |
| D4 | Confidence that microsampling could replace conventional blood sampling |
| 41(82%) | 9 |
| D5 | Problems experienced with the device | Free-text — 42 responses | 42(84%) | 8 |
E. Home / Self-Collection Experience
| Q # | Question | Answer breakdown | Answered | Not answered |
|---|---|---|---|---|
| E1 | Did you take part in Part A (home self-collection)? |
| 41(82%) | 9 |
| E2 | Satisfaction with microsampling equipment and materials |
| 39(78%) | 11 |
| E3 | Helpfulness of training materials |
| 42(84%) | 8 |
| E4 | Confidence using microsampling for self-collection |
| 44(88%) | 6 |
| E5 | Self-collection instructions were clear |
| 44(88%) | 6 |
| E6 | I was able to complete sample collection without help |
| 44(88%) | 6 |
| E7 | I had access to support during self-collection |
| 41(82%) | 9 |
| E8 | Time required for collecting and returning samples was acceptable |
| 40(80%) | 10 |
| E9 | Microsampling fitted into my usual routine |
| 42(84%) | 8 |
| E10 | I felt safe and confident during self-collection |
| 43(86%) | 7 |
| E11 | Satisfaction with shipping samples back to the lab |
| 41(82%) | 9 |
F. Training and Support
| Q # | Question | Answer breakdown | Answered | Not answered |
|---|---|---|---|---|
| F1 | Which support types were helpful? | Free-text — 45 responses | 45(90%) | 5 |
| F2 | Which factors would build your confidence in using microsampling? | Free-text — 43 responses | 43(86%) | 7 |
G. Future Preferences
| Q # | Question | Answer breakdown | Answered | Not answered |
|---|---|---|---|---|
| G1 | Preferred future blood collection location |
| 44(88%) | 6 |
| G2 | Willingness to use a microsampling device at home for regular health-related blood sampling |
| 42(84%) | 8 |
| G3 | If you answered Maybe or No, please explain | Free-text — 15 responses | 15(30%) | 35 |