Table 1 Primary and secondary outcome measures
Outcome | Metrica | Data Source | Time of Measurement(s) (Days) |
|---|---|---|---|
Co-primary outcomes | |||
 Antibiotic Taken | % filled and took antibiotic (yes/no) | Survey | 10 |
 Parent Satisfaction | % very or extremely satisfied- Likert scale (7- point) Validated | Survey | 10 |
Secondary outcomes | |||
 Shared decision-making (Process measure) | Summed Score- Knowledge and Decisional Conflict Assessment. Shared Decision-Making Questionnaire (SDM-Q-9) | Survey | 0 |
 Pediatric Quality of Life | PEDS-QL Score | Survey | 10 |
 Symptom Severity and Duration | Likert scale (7-point) Validated [22, 37]- all ages AOM-Severity of Symptom scale [38]- age 6–35 months | Survey | 0, 10 |
 1. Symptom severity (max and day 10) | Above | Survey | 0, 10 |
 2. Time to symptom improvement | Above | Survey | 0, 10 |
 3. Time to all symptom resolution | Above | Survey | 0, 10 |
 4. Time to ear pain resolution | Above | Survey | 0, 10 |
 5. Symptoms resolved at day 10 | Above | Survey | 10 |
 Missed Work, School, Daycare | # Days missed school/daycare # Days parents missed work | Survey | 10 |
 Adverse Drug Events | % with adverse drug event(s) | Survey | 10 |
 Treatment Failure | % changed management (took antibiotic if initially watchful waiting or new antibiotic if initially immediate antibiotic) | Survey and EHRb | 10 |
 Management Strategy Used (Process Measure) | % immediate antibiotic | EHR | 0 |
 Antibiotic Filled (Process Measure) | % filled antibiotic (even if not taken) | Survey | 10 |