The TOPS Trial: How Surgeons Tested the Best Time to Repair a Palate
Take the reading one piece at a time. For each piece: read it once, underline the sentence that says what happens, then look up any word in the list. Tap a word to see its definition.
Piece 1 of 2
From the TOPS trial report: the two arms repaired an isolated cleft palate at 6 months versus 12 months. The trial enrolled 558 infants with isolated cleft palate across 23 centers in Brazil, Denmark, Norway, Sweden, and the United Kingdom; infants with syndromes or severe developmental delay were excluded. A web-based algorithm randomly assigned infants 1:1, stratified by surgeon and cleft extent. Every surgeon used the same (Sommerlad) technique. The speech assessors who scored the children at age 5 worked at a central facility, unaware of each child's timing group. The primary outcome was velopharyngeal insufficiency at 5 years of age, the palate failing to close off the nose during speech.
Piece 2 of 2
The headline result: 21 of 235 children repaired at 6 months had the speech problem (8.9%), versus 34 of 226 repaired at 12 months (15.0%). Reported effect: risk ratio 0.59, 95% confidence interval 0.36 to 0.99, P = 0.04. Before the trial, the team planned about 292 children per group for 80% power at a significance level of 0.05; recruitment was hard, and the trial ended a bit below that target.
Reading the Research
- Skim the title and abstract first to get the gist.
- Circle the one sentence that states the main claim.
- Box the evidence the authors give for that claim.
- Mark one sentence that confuses you, and move on.
Now put it together: In one or two sentences, say what this whole reading is telling you about Mateo. Then go back to the lesson and fill in the guided notes.