Table 1.
Themes and sub-themes identified in investigator (PI) and research coordinator (RC) focus groups. Presented is the number of times each theme was discussed by each focus group.
| Theme/sub-theme | PI Group | RC Group |
|---|---|---|
| 1. Barriers to/enablers of the consent process | ||
| Parent/ Patient factors | ||
| Parental emotional state | ||
| Upset (distraught) | 13 | 5 |
| Inattentive | 1 | 1 |
| Parental knowledge/literacy | 2 | 3 |
| Parental primary language | 2 | 1 |
| Parental age | 1 | 1 |
| Previous experience with seizures | 6 | 4 |
| Previous attitudes/beliefs about research | 4 | 1 |
| Critically ill child | 3 | 1 |
| Ethnicity of family | 2 | |
| Overwhelmed with clinical situation, acute situation versus appointment for chronic care | 6 | 6 |
| Verbal communication with parents | ||
| Should be simplified | 3 | 2 |
| Should be standardized | 5 | 1 |
| Recommend short form | 3 | 2 |
| Recommend bulleted talking points | 4 | 1 |
| Recommend PowerPoint® presentation | 3 | |
| Physicians spoke at too high a level | 2 | |
| Confusion about meaning of off-label/why we can use unapproved medications | 3 | |
| Therapeutic misconception | 6 | 7 |
| Written communication with parents (informed consent documents) | ||
| Unrealistic risks presented | 8 | |
| Some language too complex | 7 | |
| Need for a short form | 2 | 2 |
| Environment | ||
| Need for privacy | 2 | 4 |
| Noise and interruptions in ED | 2 | 3 |
| Clinical investigators uncomfortable with consent process because of competing clinical needs | 4 | |
| Informed consent vs. time-sensitive needs of study | 7 | |
| Availability of invested investigators | 6 | |
| Investigator/Hospital | ||
| Lack of time (Cohort 1a), felt coercive sometimes | 5 | 4 |
| Sense that parents felt more comfortable asking questions of a nurse or social worker or research coordinator rather than the physician for clarification: possible implications for future enrollment studies | 1 | 2 |
| 2. Barriers/enablers to patient enrollment | ||
| Parent/ Patient factors | ||
| Pain of second intravenous stick | 3 | 4 |
| Inconvenience of staying/returning for tests | 5 | 4 |
| Not wanting to think about possible future seizures | 2 | 1 |
| Hypothetical nature of future seizure for pre-consent cohort | 2 | |
| Time between pre-consent and enrollment—some parents forgot that they were consented | 2 | |
| Young age of patient seen as a barrier | 4 | |
| Second parent not available—one parent felt uncomfortable without the other present | 3 | 1 |
| Verbal communication with parents | ||
| Coordination between clinical staff and research staff | 3 | 9 |
| Research coordinators wanted an introduction by the clinical staff | 2 | |
| Written communication with parents (informed consent documents) | ||
| Informed consent document overwhelming and inhibitory | 4 | 7 |
| Unrealistic risks listed in consent document | 8 | |
| Investigator/Hospital | ||
| Trusting relationship with | ||
| Hospital | 2 | 2 |
| ED physician/medical team | 7 | |
| Neurologist | 4 | 2 |
| Research staff | 3 | 1 |
| Personality of person enrolling | 1 | 1 |
| Environment | ||
| Clinical needs vs. needs of study | 5 | |
| 3. Ethical issues | ||
| Families who wanted to consent but didn’t understand | 7 | 4 |
| Financial compensation | ||
| Too much | 4 | 1 |
| Too little | 6 | 2 |
| How to measure understanding during consent process | 2 | 3 |
| Conflicting role as clinician and investigator | 4 |