The question

Which card determines the design?

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: A defensible study plan aligns question, design, variables, sampling, analysis, ethics, reporting, and a claim ceiling.

On your WebXam

Choosing the right design and reasoning from convergent evidence to multifactorial causation

For life

One result can have many causes; the outcome alone never tells you which.

Principle: Many roads, one ending
Five principles we return to
Two identical breaker panels with different switches turned on.
Having it is not using it
Same instructions, different switches
Two matching porch lights, one controlled by a sensor and one by a timer.
Same look, different cause
Change one thing and watch
A dimmer that changes an outcome beside a key card that only allows entry.
Boss or doorman?
Decides the result or only allows it
A beach ball held underwater and then released to the surface.
Held down, not gone
Remove the brake and it returns
Many roads leading toward one shared ending.
Many roads, one ending
One result can begin many ways
Try the everyday version first

A blueprint board checks every connection before construction

A blueprint board places parts, measurements, and connections in one view. Reviewers check the links before materials are cut or the final system is built.

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 1: Orient yourself

Which card determines the design?

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.

Clue 2: Trace one change

Where could one broken connection invalidate the plan?

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

Which boundary stops the claim from outrunning evidence?

List more than one explanation that still fits. Name the extra observation that would help you separate those possibilities.

Mixed-media blueprint table with linked cards for question, design, sample, variables, analysis, ethics, reporting, and maximum claim.
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.

  1. 1Which card determines the design?
  2. 2Where could one broken connection invalidate the plan?
  3. 3Which boundary stops the claim from outrunning evidence?
Tier 1 check

Finish with the everyday model

Use the everyday picture to answer today's question in plain words: Which card determines the design?

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: Make every method trace back to the question.
Rule 2: Supply data, safeguards, and decision rules before results are known.
Rule 3: Write the strongest claim the design could support and no stronger.

Where the analogy stops: Research plans must adapt to real participants, sites, data, and oversight after review begins.

Carry the previous idea forward

Transparent reporting lets others appraise and reproduce methods, but it cannot repair a weak design.

Today's technical takeaway

A defensible study plan aligns question, design, variables, sampling, analysis, ethics, reporting, and a claim ceiling.

Now map the same rules onto biology

Defend one complete Mateo-related study protocol

Blueprint purpose
Research question and hypothesis
Connected systems
Design, variables, sampling, and analysis
Inspection boundary
Ethics, reporting, and claim ceiling

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
EXP20-E1
The question asks whether a structured speech follow-up program is associated with improved age-8 communication after palate repair.
Why it matters: The outcome and population are specific, but the program is not randomly assigned.
EXP20-E2
The supplied synthetic CSV contains 24 coded records with program group, center, baseline score, age-8 score, and missing-data flags.
Why it matters: Students can complete the design without outside recruitment or invented measurements.
EXP20-E3
The analysis compares adjusted estimates, reports intervals and missingness, protects coded data, and follows STROBE.
Why it matters: The strongest result is an adjusted association, not proof of cause.
Make the clinical decision

You are the principal investigator at the protocol defense.

The board must select one complete plan from three proposals using only the supplied case file and dataset.

AApprove the aligned coded-records cohort with its observational claim ceiling.
BApprove a plan that recruits unnamed children and invents measurements.
CCall the program causal because the adjusted p-value is small.

Choose the defensible protocol and justify question, design, variables, sample, analysis, ethics, reporting, and claim ceiling.

Evidence required
EXP20-E1 + EXP20-E2
Claim ceiling
You may defend an adjusted observational association using the supplied dataset. You may not claim causation or require outside data.
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 plan

Track your required Tier 1 work

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 20: What New Question About Mateo Would You Investigate, and How?

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 help

If 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
Learn first

Original technical overview

Every study you read this year ran on the same eleven-step backbone, and across designs the evidence converges on one answer: Mateo's is nonsyndromic and multifactorial, many small genetic and environmental pushes, not one broken gene.

The plan

Prerequisite check

Before this page, you should know
  • Audits of animal papers found randomization reported in only about 30 to 40%, in roughly 20%, and a sample-size justification in under 10%, which is why reporting standards exist.
  • Each study type has its own reporting checklist: CONSORT for randomized trials, STROBE for observational studies, PRISMA for systematic reviews, and ARRIVE for animal research.
Today's new idea is only
Every study you read this year ran on the same eleven-step backbone, and across designs the evidence converges on one answer: Mateo's is nonsyndromic and multifactorial, many small genetic and environmental pushes, not one broken gene.
Learn first

What you will learn

Goal: Design an original, ethical, well-controlled study to answer a new question about Mateo's using the full experimental-design checklist, and state what converging evidence taught us about how scientists tell isolated from syndromic clefting.

Know by the end
  • A is the complete written plan, all eleven steps, finalized before any data are collected, so no one can change the rules after seeing the results.
  • The is the single, pre-defined, objective measure chosen in advance to answer the question; TOPS chose at age 5.
  • Multifactorial means caused by many small genetic and environmental factors acting together, rather than a single gene; agreement across different designs is stronger evidence than any one study.
  • Converging designs (case-parent trios, twin and heritability, case-control epidemiology, and the isolated clinical picture) point to a nonsyndromic, multifactorial , with a common regulatory IRF6 variant as one plausible small contributor.
The plan

Guided notes

1

Protocol and primary outcome

Model start: Writing the protocol first, before any data, is what makes a study honest, because no one can change the rules after seeing the results.
  • A is the complete written plan, every one of the eleven steps, written down ____ you collect any data.
  • The is the single, pre-defined, objective measure you decide in advance will answer your question; choosing one stops you from fishing through many measures and reporting whichever looked ____.
  • TOPS chose one : at age ____.
2

The discovery this domain was building toward

  • The converging evidence points to a that is isolated (no syndrome, no other defects) and ____: caused by many small genetic risks acting with environment and chance, not one broken gene.
  • That is why no single design could 'find the gene'; the honest description is a nonsyndromic, ____ lip and , with a common regulatory IRF6 variant as one plausible small contributor.
  • You were not told this; you ____ your way to it across the evidence, the way a real investigator does.
Explore

Reading the Research

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: Every study you read this year ran on the same eleven-step backbone, and across designs the evidence converges on one answer: Mateo's is nonsyndromic and multifactorial, many small genetic and environmental pushes, not one broken gene.
Words to unlock first
study protocolprimary outcomemultifactorialnonsyndromicconvergent evidence
Reading moves
  1. Skim the title and abstract first to get the gist.
  2. Circle the one sentence that states the main claim.
  3. Box the evidence the authors give for that claim.
  4. 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 · Experimental design capstone: full study protocol and convergent evidence for multifactorial causation
WebXam domain
Molecular and Genetic Technology
Evidence to produce
Take the question you wrote in Explore and build a full study around it. As Principal Investigator, write a one-page mini-protocol covering all eleven steps. At minimum, clearly state: (1) Question and hypothesis, plus what would prove you wrong; (2) Design and why a simpler one would not work; (3) Variables and controls; (4) Bias defenses (randomize, blind, or match); (5) Outcome and the test chosen in advance; (6) Ethics, IRB approval, who consents, whether assent is needed, and whether you have genuine equipoise. Then trade protocols with another team and play peer reviewer: find the one weakest step and suggest a fix.
Lab / skill
Biomedical Innovations (BI) · AP Biology
Words

Vocabulary (the same words your classes use)

Explore

Research citation trail (advanced)

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.

Check yourself

Exit ticket (Claim, Evidence, Reasoning)

  • Claim: Mateo's is a nonsyndromic, multifactorial cleft lip and , and I can design an original study to learn more about it.
  • Evidence: Cite two different study designs from this domain that together point to many-small-causes rather than one broken gene or a syndrome.
  • Reasoning: Explain why your own study design (name its key control or bias defense) would give a trustworthy answer to the new question you chose.
How this is graded (rubric)
For: Take the question you wrote in Explore and build a full study around it. As Principal Investigator, write a one-page mini-protocol covering all eleven steps. At minimum, clearly state: (1) Question and hypothesis, plus what would prove you wrong; (2) Design and why a simpler one would not work; (3) Variables and controls; (4) Bias defenses (randomize, blind, or match); (5) Outcome and the test chosen in advance; (6) Ethics, IRB approval, who consents, whether assent is needed, and whether you have genuine equipoise. Then trade protocols with another team and play peer reviewer: find the one weakest step and suggest a fix.
CriterionProficientDevelopingBeginning
CompleteEvery 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.
AccurateThe 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 communicationClear, organized, and labeled the way a clinician or scientist would write it.Readable but disorganized or missing labels.Hard to follow.
SubmittedTurned 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 "Take the question you wrote in Explore and build a full study around it. As Principal Investigator, write a one-page mini-protocol covering all eleven steps. At minimum, clearly state: (1) Question and hypothesis, plus what would prove you wrong; (2) Design and why a simpler one would not work; (3) Variables and controls; (4) Bias defenses (randomize, blind, or match); (5) Outcome and the test chosen in advance; (6) Ethics, IRB approval, who consents, whether assent is needed, and whether you have genuine equipoise. Then trade protocols with another team and play peer reviewer: find the one weakest step and suggest a fix.".
  • 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.
Explore

Where this leads: careers

Principal Investigator Clinical Researcher Genetic Epidemiologist Physician-Scientist

What's next: We answered the whole domain's question with this one: you can take a fresh question about Mateo's and design a sound, ethical study, and you discovered his cleft is nonsyndromic and multifactorial by reasoning across the evidence, not by being told. The studies you read this year were designed by scientists years ago. The next generation of evidence about clefts like Mateo's will come from studies that students like you design. So the question that opens onto the rest of your life: what will you ask, and who will you become to answer it?