Table 2.
Study objectives (SOs) and secondary outcomes: data sources, timing of measurement, and planned analyses.
| SOs and secondary outcomes | Data source | Timing of measurement | Planned analysis | |
| SO1: quantitative feasibility criteria | ||||
|
|
Percentage of Lianeli health questionnaires started and completed, percentage validated by GPsa, number of dedicated consultations, missing data rates before vs after GP review of the health questionnaire, percentage of documented previous screening tests, and patient error rate regarding past examinations | Lianeli CDSSb (automatically recorded metadata) | Continuously recorded from visit 1 to visit 2 (day 1 to day 60) | Descriptive statistics |
|
|
GUIDESc patient survey (22 items, including the F-SUSd; Multimedia Appendix 3) |
eCRFe or paper-based survey, with the help of research assistants if needed | After visit 2, no later than 90 days after inclusion | Descriptive statistics |
|
|
GUIDES PCPf survey (22 items, including the F-SUS) (Multimedia Appendix 4) |
eCRF or paper-based survey | At the end of the inclusion period | Descriptive statistics |
| SO1: qualitative feasibility criteria | ||||
| GUIDES-related interview canvas (Multimedia Appendix 5) | Semistructured interviews | Patients: within 1 month after study completion; PCPs: within 1 month after the last patient’s last visit at each site | Thematic analysis with deductive (GUIDES domains) and inductive coding; NVivo software | |
| SO2: organizational adjustment and interprofessional collaboration | ||||
| How centers adapt their organization to implement the Lianeli-based intervention (integration into preventive programs and workflows; patterns of interprofessional collaboration | Semistructured interviews | Patients: within 1 month after study completion; PCPs: within 1 month after the last patient’s last visit at each site | Descriptive qualitative synthesis; organizational model derived from qualitative findings | |
| SO3: explanatory variables for feasibility | ||||
|
|
Interprofessional use of Lianeli, defined as the involvement of ≥2 health professionals (including the GP) working with the patient during ADER-F | eCRF by research assistants | Documented during the intervention period (day 1 to day 60) | Exploratory regression model on the primary outcome |
|
|
Patient health literacy (HLS-EU16g, French version; range 0-16; inadequate ≤8, problematic >8 and ≤12, adequate >12) | eCRF or paper-based survey, with the help of research assistants if needed | At inclusion (visit 1) | Descriptive statistics |
|
|
Social deprivation (EPICESh score; range 0-100; higher=more deprived; threshold of 30.2 commonly used) | eCRF or paper-based survey, with the help of research assistants if needed | At inclusion (visit 1) | Descriptive statistics |
| SO4 and SO5: exploratory signals related to cancer screening participation | ||||
| Among patients eligible for at least 1 organized cancer screening (breast, colorectal, or cervical cancer) who are overdue or have never been screened: proportion attending the dedicated screening consultation within 60 d of inclusion; the same proportion is described among patients eligible for opportunistic cancer screenings | Lianeli CDSS (automatically recorded metadata) | Within 60 days of inclusion | Descriptive statistics (hypothesis-generating) | |
aGP: general practitioner.
bCDSS: clinical decision support system.
cGUIDES: Guideline Implementation with Decision Support.
dF-SUS: French version of the System Usability Scale.
eeCRF: electronic case report form.
fPCP: primary care professional.
gHLS-EU16: European Health Literacy Survey Questionnaire-16.
hEPICES: Evaluation of Precarity and Inequalities in Health Examination Centres [Evaluation de la Précarité et des Inégalités de santé dans les Centres d'Examens de Santé].