Clue 1: Orient yourself
What differs between the two paths?
Use the labels and the picture's left-to-right, near-to-far, or before-and-after order. Name only what you can point to.
The question
What did the real surgery-timing study show, and what did it leave unknown?
Why it matters: Clinical recommendations affect real children and families. Fair comparisons, bias control, ethical limits, and honest uncertainty keep a promising result from becoming a harmful claim. Today you practice the professional reasoning behind that work: TOPS supports a narrow claim: earlier repair lowered VPI in its eligible population, with uncertainty and limits.
On your WebXam
Interpreting a risk ratio and its 95% confidence interval
For life
Turn the amount up and down; the result tells you if the signal decides or just allows.
Principle: Boss or doorman?
Five principles we return to
Having it is not using it
Same instructions, different switches
Same look, different cause
Change one thing and watch
Boss or doorman?
Decides the result or only allows it
Held down, not gone
Remove the brake and it returns
Many roads, one ending
One result can begin many ways
Try the everyday version first
Two calendar windows lead to one coded five-year review
A long project may collect information during several short windows. A shared code connects the records over time without putting a name on every page.
Do not jump to the biology yet. Treat the picture as a small system. Track its parts, follow one change at a time, and keep more than one explanation open until the picture supplies a way to separate them.
Clue 2: Trace one change
What remains standardized?
Follow one object, stage, or path. Point to the first place where the situation changes instead of jumping to the ending.
Clue 3: Keep the cause open
Why are the final recordings coded?
List more than one explanation that still fits. Name the extra observation that would help you separate those possibilities.
Now inspect the illustration
Work from the visible evidence. A useful answer names the part of the picture that supports it and leaves unknown causes open.
- 1What differs between the two paths?
- 2What remains standardized?
- 3Why are the final recordings coded?
Tier 1 check
Finish with the everyday model
Use the everyday picture to answer today's question in plain words: What did the real surgery-timing study show, and what did it leave unknown?
You can complete today's required check without opening the technical details below.
Ready for the real names? Optional tier 2
Technical rules and limits
Rule 1: Read eligibility before applying the result.
Rule 2: Report effect size, interval, and outcome definition.
Rule 3: Carry safety, setting, and cleft-type limits into the conclusion.
Where the analogy stops: A calendar image hides clinical work, follow-up losses, and other outcomes that shape a real trial.
Carry the previous idea forward
Fair treatment trials require equipoise, concealed randomization, unbiased outcome assessment, and analysis by assigned group.
Today's technical takeaway
TOPS supports a narrow claim: earlier repair lowered VPI in its eligible population, with uncertainty and limits.
Now map the same rules onto biology
Read the TOPS trial from eligibility to claim ceiling
Two calendar windows
6-month and 12-month repair groups
Coded review
Blinded VPI assessment at age 5
Boundary frame
Eligibility and setting limits
Educational illustration, not a clinical photograph or a patient-specific study plan. Use the supplied evidence cards and claim ceiling.
Mateo's case file: evidence supplied in this lesson
EXP14-E1
TOPS randomized 558 medically fit infants with nonsyndromic isolated cleft palate at 23 centers.
Why it matters: The study population did not include every cleft type or setting.
EXP14-E2
VPI at age 5 occurred in 8.9 percent of the 6-month group and 15.0 percent of the 12-month group among analyzable participants.
Why it matters: The earlier group had fewer primary-outcome events.
EXP14-E3
The risk ratio was 0.59 with a 95 percent interval from 0.36 to 0.99.
Why it matters: The estimate favors earlier repair, but other outcomes and uncertainty matter.
Make the clinical decision
You are the evidence lead briefing a cleft team.
The team asks whether TOPS proves every infant with cleft lip and palate should have repair at 6 months in every center.
AApply the result to similar eligible infants while discussing uncertainty, setting, and other outcomes.
BGeneralize the result to every cleft type and center.
CIgnore the trial because its interval approaches the null.
Choose the briefing and cite population, event rates, risk ratio, and one limit.
Evidence required
EXP14-E1 + EXP14-E2 Claim ceiling
You may state the primary TOPS finding for its eligible population. You may not prescribe timing for Mateo or generalize to all clefts and settings.Go deeper Optional tier 3
Everything required for today is above. Open these only if you want the explainer, source trail, or download files.
The everyday model and Tier 1 check are the complete required path for this lesson.
Use these checks to keep your place. They are not turned in through the portal.
Check off as you finish
- Worked through the everyday picture and answered its three questions.
- Completed the Tier 1 check in plain words.
Turn in: Experimental Design lesson 14: The TOPS Trial: How Surgeons Tested the Best Time to Repair a Palate
Go to Schoology to turn this in.
Submit one PDF. Put your first and last name in the document header. Name the file: FirstName LastName - Assignment Title - YYYY-MM-DD.pdf.
Open Schoology PDF upload helpIf you cannot get in, see Mr. Mendoza. Do not skip the work.
Optional legacy technical materials Open only if you want the original notes, vocabulary, artifact, and CER work
Before this page, you should know
- A assigns patients to treatments by a chance process, and it is the strongest design for a question about which treatment causes a better outcome.
- Randomization spreads every trait, even traits never measured, roughly evenly across groups, so any difference in outcome is believably due to the treatment.
Today's new idea is only
A trial earns trust by naming one in advance and reporting its effect with uncertainty; a and its 95% say more than a bare yes or no.
Goal: Walk a real RCT from question to result, and read its (, 95% CI, p-value) to state what it proved and what it did not.
Know by the end
- TOPS compared repair at 6 months versus 12 months in 558 infants across 23 centers in five countries, excluding syndromic and severely delayed children.
- The was at 5 years; rates were 8.9% (21 of 235) at 6 months and 15.0% (34 of 226) at 12 months.
- The reported effect was 0.59, 95% 0.36 to 0.99, P = 0.04, so earlier repair lowered the chance of the speech problem, but the CI nearly touches the no-difference value of 1.0.
- TOPS did a planning about 292 children per group for 80% power at alpha 0.05; recruitment fell a bit short, which lowered power, and generalizability is limited to medically fit, isolated, non-syndromic cases.
1
Primary outcome and the risk ratio
Model start: A trial names one before it starts, then lives or dies by that result; TOPS named at 5 years. Picking it ahead of time stops a team from fishing and reporting whichever result looks best.
- A of 1.0 means ____ (no difference / a big difference); below 1.0 means the treated group had ____ (lower / higher) risk.
- TOPS got 0.59, so early repair ____ the chance of the speech problem.
- For a ratio, if the 95% excludes 1.0 the result is statistically ____; TOPS reported 0.36 to 0.99, which just barely excludes 1.0.
2
Power and generalizability
- A is the homework done ____ a trial: how many patients are needed so a real effect is likely to show up.
- TOPS planned roughly ____ per group for 80% power; recruitment fell short, which lowered power.
- Generalizability asks who the result applies to; TOPS studied medically fit, ____ (isolated / syndromic) in well-resourced centers, so its answer is strongest for children like that.
Everything you need for today is on this page. These links are optional.
What to read
Read the short plain-language explanation written for this lesson. Plain-language explainer for this lesson
Why this source matters
This explanation gives you the background for today's idea without making you decode a research paper: A trial earns trust by naming one in advance and reporting its effect with uncertainty; a and its 95% say more than a bare yes or no.
Words to unlock first
primary outcomerisk ratioconfidence intervalpower calculationgeneralizability
Reading moves
- 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.
Stop point
Stop after the final 'Use it now' section. The research citations are available separately for advanced readers.
Your output
Write one claim-evidence sentence: state the main idea, then name the example or evidence that supports it.
Where this fits
Tested on (Ohio WebXam)
Genetics of Disease · 072130
PLTW lesson
MI · Experimental Design domain · Reading a real RCT: primary outcome, risk ratio, confidence interval, power, generalizability
WebXam domain
Molecular and Genetic Technology
Evidence to produce
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).
Lab / skill
Biomedical Innovations (BI) · AP Biology
Everything required for today's decision is already in the case file and plain-language explainer. The links below are original papers and database records for teachers and advanced readers, not assigned student reading.
- Claim: Repairing an at 6 months rather than 12 months (lowers / raises / does not change) the chance of at age 5.
- Evidence: Cite the two percentages (8.9% vs 15.0%) and the with its 95% CI (0.59, 0.36 to 0.99).
- Reasoning: Explain how the excluding 1.0 lets us call the difference real, and name one group the result may not apply to.
How this is graded (rubric)
For: 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).
| 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. |
How the model answer scores against this rubric
- 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.
What's next: TOPS rested on one judgment for every child: did this 5-year-old's speech sound right, or was it nasal and unclear? But good speech is not a number a machine prints out. How do you actually measure something as fuzzy as speech, fairly and the same way for hundreds of children? We chase that next time.