Table 2 PPI considerations for the SALuBRITY trial
Target | Category | Sub-category | Considerations for SALuBRITY trial |
|---|---|---|---|
Participant information document | Design | Patient-clinician relationship | Enable single point of contact for patients throughout trial participation |
Patient-centred care | Prioritize patient well-being | ||
Escalation protocol | Develop treatment cross-over protocol Establish study emergency withdrawal protocol | ||
Randomization | Record patient treatment preference | ||
Blinding | Ensure minimal exposure to unnecessary treatment | ||
Treatment | Expectations | Assure equal treatment methods across both trial intervention arms Ensure no use of untested experimental interventions | |
Information | Inform about possible varying response to treatment Describe efforts to prevent negative treatment effects | ||
Care | Establish sufficient support during trial participation Offer experienced chiropractor treatment delivery | ||
Recruitment | Clinician costs | Time | Avoid time-consuming recruiting process Simplify recruitment documents |
Finances | Allow ongoing patient care by recruiting clinician during trial participation | ||
Patient costs | Offer tailored trial recruitment and enrolment time (e.g., acute vs. chronic radiculopathy) Minimize the number of in-person study visits | ||
Recruitment process | Restrict participation to relevant range of pain intensity (e.g., 4–7 out of 10 on pain NRS) Align treatment initiation urgency with pain intensity | ||
Outcome | Documentation | Measure and document additional medications, therapies, and activities | |
Outcome measures | Record average and peak pain intensity Include mobility, quality of life, and psychological stress as secondary outcomes Individualize primary outcome pain location and document on trial enrolment Improve PEG scale comprehension by explaining “average”, providing examples for “pain interference on general activities”, and incorporating a visual aid | ||
Pain medication | Discontinuation | Adopt a pragmatic approach for pain medication discontinuation Offer alternative pain treatment Develop emergency medication protocol | |
Clinician communication, engagement, and interaction | Contact potential clinician collaborators in person Provide feedback/status updates on trial events and milestones concerning their referred patient Implement study reminders (e.g., monthly via mail/newsletter) and disseminate findings/results | ||