Table 1.
Inclusion and Exclusion Criteria.
Fig 1.
Schedule of enrolment, procedures, assessments, and safety monitoring across study timepoints.
Columns indicate t minus 1 (HCP arm), t0 (screening), t1 (enrolment), t2 (surveys), t3 (interviews), t4 (linkage), and t5 (integration). Rows are grouped as enrolment activities, study procedures, assessments, and safety processes. “X” indicates when each activity occurs.
Fig 2.
Participant flow and consent pathway across study arms.
Following a private safety check, participants may proceed to clinician screening (Arm 1) or decline (study exit). Screening outcomes can be recorded for linkage (Arm 2) for those with MS and MSBase consent, followed by eligibility assessment and consent for further participation. Eligible participants may complete quantitative surveys (Arm 3) and or qualitative interviews (Arm 4). Mixed-methods integration occurs through triangulation (Arm 6). Boxes indicating exit, exclusion, no consent, or withdrawal represent non progression points.
Table 2.
Convergent mixed methods design.
Fig 3.
Convergent mixed-methods framework for MS focused FDSV research.
Quantitative components comprise screening of pwMS, retrospective medical data linkage for prevalence and MS related clinical and demographic associations, and surveys characterising forms of violence and abuse. Qualitative components comprise purposive interviews with pwMS and people with headache and epilepsy, and with HCPs, analysed using a combined deductive MARAM and LIVES framework and inductive thematic analysis. Findings are integrated through triangulation across study arms to inform clinical models and future policy.
Table 3.
Survey Instruments.
Fig 4.
Deductive analytic framework aligning MARAM pillars with LIVES domains to structure qualitative analysis of barriers and enablers.
Pillars 1 to 3 (shared understanding; consistent and collaborative practice; risk assessment and management) are examined for barriers and enablers reported by HCP and participants, mapped to LIVES elements (listen and validate; inquire; safety and support). Pillar 4 (systems outcomes improvement) is included as the systems level domain informing implementation and improvement outputs.