Table 5 Defining, monitoring and reporting of harm in the PRIME trial
Type of harm | Source and method of identification | Action(s) to mitigate harm to specific participants | Reporting frequency and to whom |
|---|---|---|---|
Adverse events | |||
 Positive response to ninth item of the PHQ-9: ‘Thoughts that you would be better off dead or of hurting yourself in some way’ | Participant interviews (baseline, 6 month follow-up, 12 month follow-up). Flag within electronic questionnaire prompting interviewer to act | Repeat question to reduce telescoping-type reporting errors. If ≥ 8 days in last 2 weeks, immediate referral to clinic staff. If between 1 and 7 days then written educational material given | 6-monthly report to DSMB 6-monthly to IRB (with DSMB letter of recommendation) |
 PHQ-9 score of ≥ 20 at 12 months suggesting persistent severe depression | Participant interviews (12-month follow-up). Data report (monthly) | Summary forwarded to clinic together with recommendations for further treatment | 6-monthly report to DSMB 6-monthly to IRB (with DSMB letter of recommendation) |
 Blood pressure severely raised (≥ 180/110) placing participant at immediate risk of cardiovascular event | Participant interviews (baseline, 6-month follow-up, 12-month follow-up). Flag within electronic questionnaire prompting interviewer to act | Immediate referral to clinic staff for review | 6-monthly report to DSMB 6-monthly to IRB (with DSMB letter of recommendation) |
 Raised blood pressure at follow-up representing undiagnosed or uncontrolled hypertension | Participant interviews (baseline, 6-month follow-up, 12-month follow-up). Longitudinal patient record | Summary forwarded to clinic together with recommendations for further treatment | 6-monthly report to DSMB 6-monthly to IRB (with DSMB letter of recommendation) |
Serious adverse events | |||
 Hospitalisation | Participant interviews (baseline, 6-month follow-up, 12-month follow-up). Routinely collected hospitalisation data. Data report (monthly). | No immediate action other than 6-monthly review by DSMB | 6-monthly report to DSMB 6-monthly to IRB (with DSMB letter of recommendation) |
 Death (excluding suicide) | Participant interviews (Loss to Follow-up Form). National Population Register. Data report (monthly) | No immediate action other than 6-monthly review by DSMB | 6-monthly report to DSMB 6-monthly to IRB (with DSMB letter of recommendation) |
 Death by suicide | Participant interviews (Loss to Follow-up Form). National Population Register (providing we are able to access cause of death). Data report (weekly) | Immediate notification of PI (LF) who will follow-up with fieldwork staff to confirm suicide and establish date of suicide | Notification of IRB, DSMB and NIMH within 7 days of knowledge of confirmed suicide |