Why English? | Reporting CONSORT-PRO Patient-Reported Outcomes Through Hypotheses, Instruments, Missing Data, Time Points and Interpretation

ORIENTATION

What this guide owns

Current fact check

CONSORT-PRO was published in 2013. Its five PRO-specific extensions are P1b, P2b, P6a, P12a and P20/21, covering abstract identification, hypotheses and domains, instrument evidence and administration, missing-data methods, and PRO-specific limitations and generalisability.

Canonical boundary

This article owns reporting of patient-reported outcomes in randomised trials with CONSORT-PRO. It does not select a questionnaire, validate an instrument, replace CONSORT, recover missing patient experiences or provide medical advice.

Worked example

Every chapter returns to a fictional trial comparing two supported study-rest routines while students report fatigue, sleep quality and daily functioning. It is fictional, low-stakes and educational; it does not report a real school, clinical decision or guaranteed outcome.

Warm up with eduKate’s guides to explaining scientific evidence and asking better questions in class.

CHAPTER 1 OF 13

1. Identify the PRO in the Abstract

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Why this move matters

State whether each patient-reported outcome is primary or secondary and name the central construct.

Keep the patient voice attached to a defined construct

State whether each patient-reported outcome is primary or secondary and name the central construct. Name the concept, instrument, respondent, mode, language and time point so a score remains interpretable rather than becoming a free-floating number.

Follow one response from questionnaire to estimate

Apply the item to The abstract identifies student-reported fatigue as an important secondary outcome. Trace invitation, completion, scoring, missing items, domain calculation, analysis set, group estimate and uncertainty.

Separate measurement from clinical interpretation

Describe the instrument and analysis before discussing whether a difference matters. Statistical separation, measurement validity and practical importance answer different questions.

Respect missing voices

A label in the abstract does not show how the outcome was measured. Missing patient reports can be related to illness, burden, access or withdrawal. Transparent reporting supports appraisal but cannot recover experiences that were never observed.

Student, parent and career transfer

Make one evidence card for “Identify the PRO in the Abstract”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports clinical trials, outcomes research, psychology, education research, rehabilitation, health communication and patient-centred service design without promising a grade, admission, funding decision or job.

CHAPTER 2 OF 13

2. State the PRO Hypothesis

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Why this move matters

Write the expected direction, comparison and time point rather than saying the trial will explore quality of life.

Keep the patient voice attached to a defined construct

Write the expected direction, comparison and time point rather than saying the trial will explore quality of life. Name the concept, instrument, respondent, mode, language and time point so a score remains interpretable rather than becoming a free-floating number.

Follow one response from questionnaire to estimate

Apply the item to The hypothesis predicts lower fatigue at eight weeks in the supported-rest group. Trace invitation, completion, scoring, missing items, domain calculation, analysis set, group estimate and uncertainty.

Separate measurement from clinical interpretation

Describe the instrument and analysis before discussing whether a difference matters. Statistical separation, measurement validity and practical importance answer different questions.

Respect missing voices

A post hoc hypothesis can sound prespecified unless timing is explicit. Missing patient reports can be related to illness, burden, access or withdrawal. Transparent reporting supports appraisal but cannot recover experiences that were never observed.

Student, parent and career transfer

Make one evidence card for “State the PRO Hypothesis”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports clinical trials, outcomes research, psychology, education research, rehabilitation, health communication and patient-centred service design without promising a grade, admission, funding decision or job.

CHAPTER 3 OF 13

3. Name Relevant Domains

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Why this move matters

For multidimensional outcomes, identify which domains answer the research question and which are exploratory.

Keep the patient voice attached to a defined construct

For multidimensional outcomes, identify which domains answer the research question and which are exploratory. Name the concept, instrument, respondent, mode, language and time point so a score remains interpretable rather than becoming a free-floating number.

Follow one response from questionnaire to estimate

Apply the item to Fatigue and daily functioning are prespecified while mood is exploratory. Trace invitation, completion, scoring, missing items, domain calculation, analysis set, group estimate and uncertainty.

Separate measurement from clinical interpretation

Describe the instrument and analysis before discussing whether a difference matters. Statistical separation, measurement validity and practical importance answer different questions.

Respect missing voices

Combining many domains can hide selective emphasis. Missing patient reports can be related to illness, burden, access or withdrawal. Transparent reporting supports appraisal but cannot recover experiences that were never observed.

Student, parent and career transfer

Make one evidence card for “Name Relevant Domains”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports clinical trials, outcomes research, psychology, education research, rehabilitation, health communication and patient-centred service design without promising a grade, admission, funding decision or job.

CHAPTER 4 OF 13

4. Identify the Instrument and Version

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Why this move matters

Give the complete instrument name, version, language, scoring direction, range and access information.

Keep the patient voice attached to a defined construct

Give the complete instrument name, version, language, scoring direction, range and access information. Name the concept, instrument, respondent, mode, language and time point so a score remains interpretable rather than becoming a free-floating number.

Follow one response from questionnaire to estimate

Apply the item to The report names the adolescent version and states that higher scores mean worse fatigue. Trace invitation, completion, scoring, missing items, domain calculation, analysis set, group estimate and uncertainty.

Separate measurement from clinical interpretation

Describe the instrument and analysis before discussing whether a difference matters. Statistical separation, measurement validity and practical importance answer different questions.

Respect missing voices

Similar instrument names may use different items or scoring. Missing patient reports can be related to illness, burden, access or withdrawal. Transparent reporting supports appraisal but cannot recover experiences that were never observed.

Student, parent and career transfer

Make one evidence card for “Identify the Instrument and Version”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports clinical trials, outcomes research, psychology, education research, rehabilitation, health communication and patient-centred service design without promising a grade, admission, funding decision or job.

CHAPTER 5 OF 13

5. Provide Validity and Reliability Evidence

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Why this move matters

Cite evidence relevant to the population, language and intended interpretation or explain why suitable evidence is unavailable.

Keep the patient voice attached to a defined construct

Cite evidence relevant to the population, language and intended interpretation or explain why suitable evidence is unavailable. Name the concept, instrument, respondent, mode, language and time point so a score remains interpretable rather than becoming a free-floating number.

Follow one response from questionnaire to estimate

Apply the item to The trial cites validation in adolescents and reports the gap for this local language version. Trace invitation, completion, scoring, missing items, domain calculation, analysis set, group estimate and uncertainty.

Separate measurement from clinical interpretation

Describe the instrument and analysis before discussing whether a difference matters. Statistical separation, measurement validity and practical importance answer different questions.

Respect missing voices

General validation does not prove validity in every subgroup or use. Missing patient reports can be related to illness, burden, access or withdrawal. Transparent reporting supports appraisal but cannot recover experiences that were never observed.

Student, parent and career transfer

Make one evidence card for “Provide Validity and Reliability Evidence”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports clinical trials, outcomes research, psychology, education research, rehabilitation, health communication and patient-centred service design without promising a grade, admission, funding decision or job.

CHAPTER 6 OF 13

6. Say Who Completed the Report

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Why this move matters

State whether the patient, parent proxy, caregiver or another person answered and how mixed respondent types were handled.

Keep the patient voice attached to a defined construct

State whether the patient, parent proxy, caregiver or another person answered and how mixed respondent types were handled. Name the concept, instrument, respondent, mode, language and time point so a score remains interpretable rather than becoming a free-floating number.

Follow one response from questionnaire to estimate

Apply the item to Students answer directly; parent proxy reports are analysed separately when needed. Trace invitation, completion, scoring, missing items, domain calculation, analysis set, group estimate and uncertainty.

Separate measurement from clinical interpretation

Describe the instrument and analysis before discussing whether a difference matters. Statistical separation, measurement validity and practical importance answer different questions.

Respect missing voices

Proxy and self-report can represent different perspectives. Missing patient reports can be related to illness, burden, access or withdrawal. Transparent reporting supports appraisal but cannot recover experiences that were never observed.

Student, parent and career transfer

Make one evidence card for “Say Who Completed the Report”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports clinical trials, outcomes research, psychology, education research, rehabilitation, health communication and patient-centred service design without promising a grade, admission, funding decision or job.

CHAPTER 7 OF 13

7. Report Mode, Language and Time Points

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Why this move matters

Describe paper, telephone, electronic or other administration, recall period, language, assistance and exact assessment schedule.

Keep the patient voice attached to a defined construct

Describe paper, telephone, electronic or other administration, recall period, language, assistance and exact assessment schedule. Name the concept, instrument, respondent, mode, language and time point so a score remains interpretable rather than becoming a free-floating number.

Follow one response from questionnaire to estimate

Apply the item to Students complete an electronic seven-day recall questionnaire at baseline, four weeks and eight weeks. Trace invitation, completion, scoring, missing items, domain calculation, analysis set, group estimate and uncertainty.

Separate measurement from clinical interpretation

Describe the instrument and analysis before discussing whether a difference matters. Statistical separation, measurement validity and practical importance answer different questions.

Respect missing voices

Changing mode or recall period can change responses. Missing patient reports can be related to illness, burden, access or withdrawal. Transparent reporting supports appraisal but cannot recover experiences that were never observed.

Student, parent and career transfer

Make one evidence card for “Report Mode, Language and Time Points”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports clinical trials, outcomes research, psychology, education research, rehabilitation, health communication and patient-centred service design without promising a grade, admission, funding decision or job.

CHAPTER 8 OF 13

8. Show Baseline and Follow-Up Completion

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Why this move matters

Give the number expected and completed by group and time point, with reasons where known.

Keep the patient voice attached to a defined construct

Give the number expected and completed by group and time point, with reasons where known. Name the concept, instrument, respondent, mode, language and time point so a score remains interpretable rather than becoming a free-floating number.

Follow one response from questionnaire to estimate

Apply the item to A table shows 120 expected, 112 baseline and 94 eight-week reports in one group. Trace invitation, completion, scoring, missing items, domain calculation, analysis set, group estimate and uncertainty.

Separate measurement from clinical interpretation

Describe the instrument and analysis before discussing whether a difference matters. Statistical separation, measurement validity and practical importance answer different questions.

Respect missing voices

A percentage without its denominator hides who disappeared. Missing patient reports can be related to illness, burden, access or withdrawal. Transparent reporting supports appraisal but cannot recover experiences that were never observed.

Student, parent and career transfer

Make one evidence card for “Show Baseline and Follow-Up Completion”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports clinical trials, outcomes research, psychology, education research, rehabilitation, health communication and patient-centred service design without promising a grade, admission, funding decision or job.

CHAPTER 9 OF 13

9. Explain Missing-Data Methods

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Why this move matters

Describe item-level and questionnaire-level missingness, assumptions, thresholds, imputation and sensitivity analyses.

Keep the patient voice attached to a defined construct

Describe item-level and questionnaire-level missingness, assumptions, thresholds, imputation and sensitivity analyses. Name the concept, instrument, respondent, mode, language and time point so a score remains interpretable rather than becoming a free-floating number.

Follow one response from questionnaire to estimate

Apply the item to The analysis distinguishes skipped items from entirely missing follow-up forms. Trace invitation, completion, scoring, missing items, domain calculation, analysis set, group estimate and uncertainty.

Separate measurement from clinical interpretation

Describe the instrument and analysis before discussing whether a difference matters. Statistical separation, measurement validity and practical importance answer different questions.

Respect missing voices

No statistical method can guarantee that unobserved experiences match observed ones. Missing patient reports can be related to illness, burden, access or withdrawal. Transparent reporting supports appraisal but cannot recover experiences that were never observed.

Student, parent and career transfer

Make one evidence card for “Explain Missing-Data Methods”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports clinical trials, outcomes research, psychology, education research, rehabilitation, health communication and patient-centred service design without promising a grade, admission, funding decision or job.

CHAPTER 10 OF 13

10. Report Group, Domain and Time-Point Estimates

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Why this move matters

Give results for each group, domain and prespecified time point with effect estimates and uncertainty.

Keep the patient voice attached to a defined construct

Give results for each group, domain and prespecified time point with effect estimates and uncertainty. Name the concept, instrument, respondent, mode, language and time point so a score remains interpretable rather than becoming a free-floating number.

Follow one response from questionnaire to estimate

Apply the item to The report shows mean fatigue by group plus the between-group difference and confidence interval. Trace invitation, completion, scoring, missing items, domain calculation, analysis set, group estimate and uncertainty.

Separate measurement from clinical interpretation

Describe the instrument and analysis before discussing whether a difference matters. Statistical separation, measurement validity and practical importance answer different questions.

Respect missing voices

A significant p value alone does not show magnitude or precision. Missing patient reports can be related to illness, burden, access or withdrawal. Transparent reporting supports appraisal but cannot recover experiences that were never observed.

Student, parent and career transfer

Make one evidence card for “Report Group, Domain and Time-Point Estimates”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports clinical trials, outcomes research, psychology, education research, rehabilitation, health communication and patient-centred service design without promising a grade, admission, funding decision or job.

CHAPTER 11 OF 13

11. Explain Practical or Clinical Meaning

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Why this move matters

State any prespecified responder definition or meaningful-change threshold, its source and uncertainty.

Keep the patient voice attached to a defined construct

State any prespecified responder definition or meaningful-change threshold, its source and uncertainty. Name the concept, instrument, respondent, mode, language and time point so a score remains interpretable rather than becoming a free-floating number.

Follow one response from questionnaire to estimate

Apply the item to A five-point threshold is cited but discussed as a population aid rather than an individual verdict. Trace invitation, completion, scoring, missing items, domain calculation, analysis set, group estimate and uncertainty.

Separate measurement from clinical interpretation

Describe the instrument and analysis before discussing whether a difference matters. Statistical separation, measurement validity and practical importance answer different questions.

Respect missing voices

Thresholds can vary by population, method and purpose. Missing patient reports can be related to illness, burden, access or withdrawal. Transparent reporting supports appraisal but cannot recover experiences that were never observed.

Student, parent and career transfer

Make one evidence card for “Explain Practical or Clinical Meaning”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports clinical trials, outcomes research, psychology, education research, rehabilitation, health communication and patient-centred service design without promising a grade, admission, funding decision or job.

CHAPTER 12 OF 13

12. Discuss PRO-Specific Limitations and Generalisability

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Why this move matters

Address missingness, respondent burden, language, instrument fit, mode changes and whose experience may be absent.

Keep the patient voice attached to a defined construct

Address missingness, respondent burden, language, instrument fit, mode changes and whose experience may be absent. Name the concept, instrument, respondent, mode, language and time point so a score remains interpretable rather than becoming a free-floating number.

Follow one response from questionnaire to estimate

Apply the item to The discussion notes that students with greatest fatigue were less likely to complete follow-up. Trace invitation, completion, scoring, missing items, domain calculation, analysis set, group estimate and uncertainty.

Separate measurement from clinical interpretation

Describe the instrument and analysis before discussing whether a difference matters. Statistical separation, measurement validity and practical importance answer different questions.

Respect missing voices

A polished average can underrepresent the people least able to respond. Missing patient reports can be related to illness, burden, access or withdrawal. Transparent reporting supports appraisal but cannot recover experiences that were never observed.

Student, parent and career transfer

Make one evidence card for “Discuss PRO-Specific Limitations and Generalisability”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports clinical trials, outcomes research, psychology, education research, rehabilitation, health communication and patient-centred service design without promising a grade, admission, funding decision or job.

CHAPTER 13 OF 13

13. Integrate PROs With Other Outcomes and Open Materials

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Why this move matters

Relate patient reports to clinical or behavioural outcomes, protocol plans and accessible instruments without allowing one outcome to erase another.

Keep the patient voice attached to a defined construct

Relate patient reports to clinical or behavioural outcomes, protocol plans and accessible instruments without allowing one outcome to erase another. Name the concept, instrument, respondent, mode, language and time point so a score remains interpretable rather than becoming a free-floating number.

Follow one response from questionnaire to estimate

Apply the item to Fatigue is discussed beside attendance and functioning rather than used as a substitute for them. Trace invitation, completion, scoring, missing items, domain calculation, analysis set, group estimate and uncertainty.

Separate measurement from clinical interpretation

Describe the instrument and analysis before discussing whether a difference matters. Statistical separation, measurement validity and practical importance answer different questions.

Respect missing voices

Different outcomes can disagree without one being false. Missing patient reports can be related to illness, burden, access or withdrawal. Transparent reporting supports appraisal but cannot recover experiences that were never observed.

Student, parent and career transfer

Make one evidence card for “Integrate PROs With Other Outcomes and Open Materials”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports clinical trials, outcomes research, psychology, education research, rehabilitation, health communication and patient-centred service design without promising a grade, admission, funding decision or job.

PRACTICE LAB

Build a patient-reported outcome decision trail

Student route

1. Choose one original report inside this guide’s scope.
2. Copy its objective and underline actor, action, context, evidence and intended decision.
3. Draw the specific reasoning chain used in this article.
4. Mark each step reported, inferred, contested or unknown.
5. Rewrite the conclusion so it preserves the narrowest important limitation.

Parent or teacher route

Ask the learner to explain CONSORT-PRO’s central reporting method twice: once to a classmate and once to a method specialist. Praise a precise correction and a well-stated unknown; both show disciplined attention to evidence.

Early-career route

Create a one-page CONSORT-PRO audit with source link, date checked, scope, method logic, decisive wording, contrary evidence, limit and next action. A colleague should be able to continue without guessing.

Continue with eduKate’s guides to reading course and career information and giving useful feedback in group projects.

USEFUL NEXT READING

Connect this narrow owner to its neighbour

Read the SPIRIT-Outcomes and CONSORT-Outcomes guide for a related but different reader job. Return here when the question is specifically how to keep the patient voice visible from the first hypothesis to the final interpretation. This boundary keeps one canonical owner per intent.

For English practice across research, school and career communication, visit the English at work and in public life guide.

FREQUENTLY ASKED QUESTIONS

Questions students and parents often ask

What is a patient-reported outcome?

A report about health, symptoms, functioning or quality of life provided directly by the patient.

How many PRO-specific CONSORT items are there?

Five: P1b, P2b, P6a, P12a and P20/21.

Does CONSORT-PRO replace CONSORT?

No. It supplements the main CONSORT guideline.

Is a parent proxy report the same as self-report?

No. Both can be useful, but the respondent must be identified and analysed appropriately.

Does statistical significance prove meaningful benefit?

No. Magnitude, uncertainty and interpretability also matter.

Can imputation recover every missing patient voice?

No. It depends on assumptions and should be accompanied by sensitivity analysis and honest limits.