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 |
|