Table 2.
Evaluation criteria.
| A. Scoring Criteria for Swallowability | |||
| Score | Observation | ||
| 1 | Swallowed | No chewing took place during deglutition and no residuals of the solid were found during oral inspection. | |
| 2 | Chewed/left over | Chewing was observed before deglutition and/or that the whole or parts of the solid were found in the mouth during oral inspection and/or some mini-tablets left over on the spoon (≥80% should have been swallowed). | |
| 3 | Spat out | No deglutition took place and the solid was no longer in the child’s mouth. | |
| 4 | Choked on | The solid was swallowed the wrong way or a cough was caused. | |
| 5 | Refused to take | The child did not allow the investigator to place the solid in the mouth and/or <80% of mini-tablets swallowed. | |
| B. Definition of acceptability derived from swallowability alone | |||
| Criteria | |||
| Acceptable | Yes | Swallowability score was 1 or 2 | |
| No | Swallowability score was >2 (3–5) | ||
| C. Scoring criteria for palatability | |||
| Score | Assessment | Interpretation | |
| 1 | Pleasant | Positive hedonic pattern: Tongue protrusion, smack of mouth and lips, finger sucking, corner elevation | |
| 2 | Neutral | Neutral mouth and body movements, and face expressions (irregular and involving lips) | |
| 3 | Unpleasant | Negative aversive pattern: Gape, nose wrinkle, eye squinch, frown, grimace, head shake, arm flail | |
| D. Scoring criteria for composite acceptability endpoint derived from palatability and swallowability | |||
| Palatability | Swallowability score | ||
| 1 | 2 | ≥3 | |
| Pleasant | High | Good | No |
| Neutral | Good | Low | No |
| Unpleasant | Low | No | No |
| E. Acceptability as composite acceptability endpoint | |||
| Yes: High/good | |||
| No: low/no | |||