The TOPS Trial: How Surgeons Tested the Best Time to Repair a Palate
Experimental Design domain · Lesson 14 of 20 · Biomedical Innovations (BI)
Today's goal: Walk a real RCT from question to result, and read its primary outcome (risk ratio, 95% CI, p-value) to state what it proved and what it did not.
This is a model of the work you should turn in. Use it to check your own: match the structure and the level of detail, do not copy it. Your wording should be your own.
TOPS asked whether repairing an isolated cleft palate at 6 months versus 12 months changes speech, and randomized 558 infants to those two ages.
The speech problem (velopharyngeal insufficiency) at age 5 was less common after earlier repair, 8.9% versus 15.0%, with a risk ratio of 0.59, meaning the 6-month group's risk was about 59% of the 12-month group's.
The one honest limit: the 95% confidence interval (0.36 to 0.99) nearly reaches the no-difference value of 1.0, and the trial studied medically fit infants with isolated, non-syndromic clefts, so it speaks most strongly to children like that.
This model shows the level of evidence and organization needed to complete: A three-sentence brief that reports a real RCT result, its direction, and one honest limit.
- State the question and method.
- Present the observations and data with units.
- Explain the result, limitations, and next investigation.
Keep the structure. Replace the question, facts, measurements, and evidence. Then recheck units, vocabulary, and whether the conclusion goes beyond the evidence.
The finished product above did not appear all at once. Here is the path from the question to the turned-in work, so you can follow the same steps.
- 1Start from today's question: What did the real surgery-timing study show, and what did it leave unknown?
- 2Work the Model and the Explore questions to reason it out before writing anything.
- 3Pull the specific evidence the product needs from the reading and any database you used.
- 4Write it up in the required format: Your team is deciding when to schedule a repair, and a parent asks whether there is real evidence for the timing. Using only the model, write a three-sentence brief: (1) state the question TOPS asked and the two ages compared; (2) state the result in plain words, using the two percentages and the direction of the ; (3) state one honest limit (whom the result applies to, or that the came close to no difference).
- 5Check it against the rubric, then submit.
| Criterion | Proficient | Developing | Beginning |
|---|---|---|---|
| Complete | Every required part of the artifact is present and filled in. | Most parts are present, but one is missing or left blank. | Several parts are missing. |
| Accurate | The science and data are correct and match the evidence. | Mostly correct, with a small factual slip. | Key science or data is wrong. |
| Scientific reasoning (CER) | States a claim, backs it with specific evidence, and explains the reasoning. | Has a claim and evidence, but the reasoning is thin or missing. | Gives an answer with no evidence or reasoning. |
| Professional communication | Clear, organized, and labeled the way a clinician or scientist would write it. | Readable but disorganized or missing labels. | Hard to follow. |
| Submitted | Turned in through the route named under Submit here and confirmed. | Turned in, but in the wrong place or unconfirmed. | Not turned in. |
- CompleteProficient: Nothing is left blank: the model fills every part of "Your cleft team is deciding when to schedule a palate repair, and a parent asks whether there is real evidence for the timing. Using only the model, write a three-sentence brief: (1) state the question TOPS asked and the two ages compared; (2) state the primary outcome result in plain words, using the two percentages and the direction of the risk ratio; (3) state one honest limit (whom the result applies to, or that the confidence interval came close to no difference).".
- AccurateProficient: Every number and claim matches the case evidence.
- Scientific reasoning (CER)Proficient: It names a claim, cites the specific evidence, and explains the reasoning, not just the answer.
- Professional communicationProficient: It is organized and labeled like a real chart note.
- SubmittedProficient: It would be attached to your class form or handed in, and confirmed.
One exam-style question that uses exactly what you practiced today. Try it before you reveal the answer, then read why each choice is right or wrong.
Tap an answer to see the full explanation. Nothing is recorded or graded.
It builds this reusable test skill: Interpreting a risk ratio and its 95% confidence interval.
- Name the concept or data pattern being tested.
- Cross out choices that violate that rule or the evidence.
- Justify the best remaining choice before checking the answer.