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Table 6 Endpoint type for secondary outcomes

From: A randomised controlled trial comparing palate surgery at 6 months versus 12 months of age (the TOPS trial): a statistical analysis plan

Outcome type Outcome
Dichotomous 1b: Insufficient velopharyngeal function (VPC rate) at 5 years
2a: Insufficient velopharyngeal function (VPC rate) at 3 years
3a: Canonical babbling present at 12 months
6a: Postoperative dehiscence
6b: Postoperative infection
6c: Evidence of fistula
7ai: Abnormal Transient Otoacoustic Emission (TEOAE) at 12 months
7aii: Abnormal sound field audiometry at 12 months
7bi_1: Abnormal pure tone audiometry in at least one ear at 3 years
7bi_2: Abnormal pure tone audiometry in at least one ear at 5 years
7bii_1: Abnormal pure tone audiometry in both ears at 3 years
7bii_2: Abnormal pure tone audiometry in both ears at 5 years
8a_1: Flat line tympanogram in at least one ear at 12 months
8a_2: Flat line tympanogram in at least one ear at 3 years
8a_3: Flat line tympanogram in at least one ear at 5 years
8b_1: Flat line tympanogram in both ears at 12 months
8b_2: Flat line tympanogram in both ears at 3 years
8b_3: Flat line tympanogram in both ears at 5 years
Short ordinal 7biii_1: Severity of better ear at 3 years
7biii_2: Severity of better ear at 5 years
Long ordinal 1a: Velopharyngeal composite score summary (VPC sum) at 5 years
Bounded continuous 2b: Velopharyngeal insufficiency symptoms at 3 years
3b: Canonical babbling ratio at 12 months
4a: Percent consonants correct (PCC) at 3 years
4b: Percent correct placement (PCP) at 3 years
4c: Percent correct manner (PCM) at 3 years
4d: Non-oral consonant errors at 3 years
4e: Oral consonant errors at 3 years
5a: Percent consonants correct (PCC) at 5 years
5b: Percent correct placement (PCP) at 5 years
5c: Percent correct manner (PCM) at 5 years
5d: Non-oral consonant errors at 5 years
5e: Oral consonant errors at 5 years
9b: Maxillary arch constriction score at 5 years
Continuous 3c: Consonant inventory at 12 months
9a: Soft tissue ANB angle at 5 years
10a: Nude weight at 12 months
10b: Crown to heel length at 12 months
10c: Occipitofrontal circumference at 12 months
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