Why English? | Planning SPIRIT-PRO Trial Protocols Through Patient-Reported Outcomes, Instruments, Time Points, Missing Data and Interpretation

WHY ENGLISH?

Plan the patient voice before the first participant is asked to answer

A patient-reported outcome records symptoms, function or quality of life directly from the patient. In a trial protocol, the important English work happens before results exist: the team must specify why the outcome matters, what will be measured, who will answer, when data will be collected and how missing responses will be handled.

The SPIRIT-PRO extension was published in JAMA in February 2018 for protocols in which patient-reported outcomes are primary or key secondary outcomes. It contains 16 items—11 extensions and five elaborations—to be used with the main SPIRIT protocol guidance.

Precise protocol language protects patients and researchers from avoidable ambiguity. It can reduce selective reporting, inconsistent administration and unplanned analysis, but it cannot guarantee that every participant will respond or that a statistically detectable difference will be meaningful.

READING ROUTE
Purpose and responsibility

Name the PRO question and accountable people.

READING ROUTE
Instrument and schedule

Specify domains, respondents, modes and time points.

READING ROUTE
Completion and analysis

Plan monitoring, missing data and statistics.

READING ROUTE
Interpretation and access

Preserve thresholds, harms, documents and limits.

Open the full article contents

Article contents

Open all chapters

1. Name Who Is Responsible for PRO Content
2. Explain the PRO Rationale and Prior Evidence
3. State PRO Objectives, Hypotheses and Domains
4. Define PRO-Specific Eligibility and Subsampling
5. Specify Concepts, Metrics and Principal Time Points
6. Identify Instrument, Version and Measurement Evidence
7. Say Who Reports and How Administration Works
8. Design a Feasible Assessment Schedule
9. Plan Strategies to Reduce Missing PRO Data
10. Distinguish Missing Items From Missed Assessments
11. Prespecify Analysis and Interpretation
12. Plan Monitoring, Harms and Protocol Changes
13. Make PRO Documents and Dissemination Routes Visible

ORIENTATION

What this guide owns

Current fact check

SPIRIT-PRO was published in 2018 and recommends 16 protocol items: 11 extensions and five elaborations. A 2021 explanation-and-elaboration paper provides implementation examples and distinguishes missing items from wholly missed assessments.

Canonical boundary

This article owns planning patient-reported outcomes in trial protocols. The CONSORT-PRO article owns reporting completed trial results, while SPIRIT-Outcomes owns broader outcome specification across trial protocols.

Worked example

Every chapter returns to a fictional protocol testing a supported study-rest programme 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.

Did You Know? For SPIRIT-PRO, complete reporting makes appraisal possible but does not perform the appraisal, remove bias or guarantee transfer.

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

CHAPTER 1 OF 13

1. Name Who Is Responsible for PRO Content

Back to contents

Why this move matters

Specify the people accountable for the patient-reported outcome sections and their relevant expertise.

Did You Know? SPIRIT5a-PRO elaborates protocol responsibility.

Turn patient experience into a protocol decision

Specify the people accountable for the patient-reported outcome sections and their relevant expertise. Connect the concept or domain to an instrument, respondent, schedule, analysis metric and principal time point before recruitment begins.

Walk through one planned assessment

Use The protocol names an outcomes researcher and a student-advisory lead rather than assigning responsibility to the team generally. Trace invitation, language and mode, completion, scoring, reminders, missed items, missed assessments, analysis and interpretation as planned rather than reconstructed after results.

Protect the people least likely to respond

Plan how burden, illness, disability, access, language and withdrawal may affect completion. Record reasons for missed assessments and distinguish self-report from proxy-report without treating one as a silent substitute for the other.

Prespecify without pretending certainty

Named responsibility does not eliminate collective review or patient involvement. A complete protocol reduces avoidable ambiguity and research waste, but it cannot guarantee retention, valid measurement in every subgroup or a meaningful treatment effect.

Practical reader check

Point to the exact source or method sentence supporting the claim.
Name the person, setting, date, input and decision rule that could change its meaning.
Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Name Who Is Responsible for PRO Content”: 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, psychology, rehabilitation, outcomes research, education research, health policy and patient-centred service design without promising a grade, admission, funding decision or job.

CHAPTER 2 OF 13

2. Explain the PRO Rationale and Prior Evidence

Back to contents

Why this move matters

Connect the intervention, patient experience, existing evidence and reason the selected outcome is necessary.

Did You Know? SPIRIT6a-PRO asks for the research question, rationale and relevant prior findings.

Turn patient experience into a protocol decision

Connect the intervention, patient experience, existing evidence and reason the selected outcome is necessary. Connect the concept or domain to an instrument, respondent, schedule, analysis metric and principal time point before recruitment begins.

Walk through one planned assessment

Use Fatigue is included because earlier studies show burden not captured by attendance alone. Trace invitation, language and mode, completion, scoring, reminders, missed items, missed assessments, analysis and interpretation as planned rather than reconstructed after results.

Protect the people least likely to respond

Prespecify without pretending certainty

A plausible rationale does not validate the selected instrument. A complete protocol reduces avoidable ambiguity and research waste, but it cannot guarantee retention, valid measurement in every subgroup or a meaningful treatment effect.

Practical reader check

Point to the exact source or method sentence supporting the claim.
Name the person, setting, date, input and decision rule that could change its meaning.
Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Explain the PRO Rationale and Prior 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, psychology, rehabilitation, outcomes research, education research, health policy and patient-centred service design without promising a grade, admission, funding decision or job.

CHAPTER 3 OF 13

3. State PRO Objectives, Hypotheses and Domains

Back to contents

Why this move matters

Prespecify direction, comparison, domain and principal time point instead of promising to explore quality of life.

Did You Know? SPIRIT7-PRO distinguishes concepts and domains within multidimensional outcomes.

Turn patient experience into a protocol decision

Prespecify direction, comparison, domain and principal time point instead of promising to explore quality of life. Connect the concept or domain to an instrument, respondent, schedule, analysis metric and principal time point before recruitment begins.

Walk through one planned assessment

Use The hypothesis predicts lower fatigue at eight weeks in the supported-rest group. Trace invitation, language and mode, completion, scoring, reminders, missed items, missed assessments, analysis and interpretation as planned rather than reconstructed after results.

Protect the people least likely to respond

Prespecify without pretending certainty

Post hoc domain selection can make chance findings look planned. A complete protocol reduces avoidable ambiguity and research waste, but it cannot guarantee retention, valid measurement in every subgroup or a meaningful treatment effect.

Practical reader check

Point to the exact source or method sentence supporting the claim.
Name the person, setting, date, input and decision rule that could change its meaning.
Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “State PRO Objectives, Hypotheses and 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, psychology, rehabilitation, outcomes research, education research, health policy and patient-centred service design without promising a grade, admission, funding decision or job.

CHAPTER 4 OF 13

4. Define PRO-Specific Eligibility and Subsampling

Back to contents

Why this move matters

Report language, reading, access or prerandomisation requirements and justify any PRO subsample.

Did You Know? SPIRIT10-PRO makes PRO-specific inclusion decisions visible.

Turn patient experience into a protocol decision

Report language, reading, access or prerandomisation requirements and justify any PRO subsample. Connect the concept or domain to an instrument, respondent, schedule, analysis metric and principal time point before recruitment begins.

Walk through one planned assessment

Use Students may use an approved language version; the protocol explains why some sites cannot collect one instrument. Trace invitation, language and mode, completion, scoring, reminders, missed items, missed assessments, analysis and interpretation as planned rather than reconstructed after results.

Protect the people least likely to respond

Prespecify without pretending certainty

Eligibility rules can exclude the very people whose burden is greatest. A complete protocol reduces avoidable ambiguity and research waste, but it cannot guarantee retention, valid measurement in every subgroup or a meaningful treatment effect.

Practical reader check

Point to the exact source or method sentence supporting the claim.
Name the person, setting, date, input and decision rule that could change its meaning.
Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Define PRO-Specific Eligibility and Subsampling”: 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, psychology, rehabilitation, outcomes research, education research, health policy and patient-centred service design without promising a grade, admission, funding decision or job.

CHAPTER 5 OF 13

5. Specify Concepts, Metrics and Principal Time Points

Back to contents

Why this move matters

For every domain, state the variable, analysis metric and main time point or period of interest.

Did You Know? SPIRIT12-PRO aligns domains, metrics and time.

Turn patient experience into a protocol decision

For every domain, state the variable, analysis metric and main time point or period of interest. Connect the concept or domain to an instrument, respondent, schedule, analysis metric and principal time point before recruitment begins.

Walk through one planned assessment

Use Fatigue change from baseline to eight weeks is primary; daily functioning at four weeks is secondary. Trace invitation, language and mode, completion, scoring, reminders, missed items, missed assessments, analysis and interpretation as planned rather than reconstructed after results.

Protect the people least likely to respond

Prespecify without pretending certainty

A schedule alone does not identify the analysis metric. A complete protocol reduces avoidable ambiguity and research waste, but it cannot guarantee retention, valid measurement in every subgroup or a meaningful treatment effect.

Practical reader check

Point to the exact source or method sentence supporting the claim.
Name the person, setting, date, input and decision rule that could change its meaning.
Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Specify Concepts, Metrics and Principal 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, psychology, rehabilitation, outcomes research, education research, health policy and patient-centred service design without promising a grade, admission, funding decision or job.

CHAPTER 6 OF 13

6. Identify Instrument, Version and Measurement Evidence

Back to contents

Why this move matters

Give the full name, version, language, score direction, access and evidence relevant to the intended population and use.

Did You Know? Instrument identity is essential for reproducibility and interpretation.

Turn patient experience into a protocol decision

Give the full name, version, language, score direction, access and evidence relevant to the intended population and use. Connect the concept or domain to an instrument, respondent, schedule, analysis metric and principal time point before recruitment begins.

Walk through one planned assessment

Use The adolescent instrument version is cited with validation evidence and a stated gap for one language group. Trace invitation, language and mode, completion, scoring, reminders, missed items, missed assessments, analysis and interpretation as planned rather than reconstructed after results.

Protect the people least likely to respond

Prespecify without pretending certainty

Validation in one population does not prove validity everywhere. A complete protocol reduces avoidable ambiguity and research waste, but it cannot guarantee retention, valid measurement in every subgroup or a meaningful treatment effect.

Practical reader check

Point to the exact source or method sentence supporting the claim.
Name the person, setting, date, input and decision rule that could change its meaning.
Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Identify Instrument, Version and Measurement 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, psychology, rehabilitation, outcomes research, education research, health policy and patient-centred service design without promising a grade, admission, funding decision or job.

CHAPTER 7 OF 13

7. Say Who Reports and How Administration Works

Back to contents

Why this move matters

Distinguish self-report and proxy-report, mode, recall period, assistance, setting and procedures for mixed respondents.

Did You Know? Administration can change the meaning and completeness of a response.

Turn patient experience into a protocol decision

Distinguish self-report and proxy-report, mode, recall period, assistance, setting and procedures for mixed respondents. Connect the concept or domain to an instrument, respondent, schedule, analysis metric and principal time point before recruitment begins.

Walk through one planned assessment

Use Students answer electronically; proxy reports are collected only under a prespecified rule and kept separate. Trace invitation, language and mode, completion, scoring, reminders, missed items, missed assessments, analysis and interpretation as planned rather than reconstructed after results.

Protect the people least likely to respond

Prespecify without pretending certainty

Proxy and patient perspectives are not interchangeable. A complete protocol reduces avoidable ambiguity and research waste, but it cannot guarantee retention, valid measurement in every subgroup or a meaningful treatment effect.

Practical reader check

Point to the exact source or method sentence supporting the claim.
Name the person, setting, date, input and decision rule that could change its meaning.
Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Say Who Reports and How Administration Works”: 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, psychology, rehabilitation, outcomes research, education research, health policy and patient-centred service design without promising a grade, admission, funding decision or job.

CHAPTER 8 OF 13

8. Design a Feasible Assessment Schedule

Back to contents

Why this move matters

Align assessments with intervention stages, burden, clinic or school visits and the principal analysis time point.

Did You Know? A protocol should balance measurement value with participant burden.

Turn patient experience into a protocol decision

Align assessments with intervention stages, burden, clinic or school visits and the principal analysis time point. Connect the concept or domain to an instrument, respondent, schedule, analysis metric and principal time point before recruitment begins.

Walk through one planned assessment

Use Baseline, four-week and eight-week forms are scheduled beside existing visits to reduce burden. Trace invitation, language and mode, completion, scoring, reminders, missed items, missed assessments, analysis and interpretation as planned rather than reconstructed after results.

Protect the people least likely to respond

Prespecify without pretending certainty

Convenient timing may miss the effect window that matters. A complete protocol reduces avoidable ambiguity and research waste, but it cannot guarantee retention, valid measurement in every subgroup or a meaningful treatment effect.

Practical reader check

Point to the exact source or method sentence supporting the claim.
Name the person, setting, date, input and decision rule that could change its meaning.
Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Design a Feasible Assessment Schedule”: 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, psychology, rehabilitation, outcomes research, education research, health policy and patient-centred service design without promising a grade, admission, funding decision or job.

CHAPTER 9 OF 13

9. Plan Strategies to Reduce Missing PRO Data

Back to contents

Why this move matters

Describe reminders, flexible modes, staff training, burden reduction and collection of reasons for missed assessments.

Did You Know? Prevention and documentation are different from statistical handling.

Turn patient experience into a protocol decision

Describe reminders, flexible modes, staff training, burden reduction and collection of reasons for missed assessments. Connect the concept or domain to an instrument, respondent, schedule, analysis metric and principal time point before recruitment begins.

Walk through one planned assessment

Use Participants can complete remotely within a defined window and are asked why an assessment was missed. Trace invitation, language and mode, completion, scoring, reminders, missed items, missed assessments, analysis and interpretation as planned rather than reconstructed after results.

Protect the people least likely to respond

Prespecify without pretending certainty

Retention strategies must not pressure a person who wishes to stop. A complete protocol reduces avoidable ambiguity and research waste, but it cannot guarantee retention, valid measurement in every subgroup or a meaningful treatment effect.

Practical reader check

Point to the exact source or method sentence supporting the claim.
Name the person, setting, date, input and decision rule that could change its meaning.
Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Plan Strategies to Reduce Missing PRO Data”: 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, psychology, rehabilitation, outcomes research, education research, health policy and patient-centred service design without promising a grade, admission, funding decision or job.

CHAPTER 10 OF 13

10. Distinguish Missing Items From Missed Assessments

Back to contents

Why this move matters

Specify scoring-manual rules for skipped questions and statistical assumptions for wholly missing assessments.

Did You Know? The explanation paper treats wholly missed assessments as the more serious problem.

Turn patient experience into a protocol decision

Specify scoring-manual rules for skipped questions and statistical assumptions for wholly missing assessments. Connect the concept or domain to an instrument, respondent, schedule, analysis metric and principal time point before recruitment begins.

Walk through one planned assessment

Use A partly completed scale follows the manual; a missing visit enters the prespecified sensitivity analysis. Trace invitation, language and mode, completion, scoring, reminders, missed items, missed assessments, analysis and interpretation as planned rather than reconstructed after results.

Protect the people least likely to respond

Prespecify without pretending certainty

Single-item measures cannot use the same item-imputation rules as multi-item scales. A complete protocol reduces avoidable ambiguity and research waste, but it cannot guarantee retention, valid measurement in every subgroup or a meaningful treatment effect.

Practical reader check

Point to the exact source or method sentence supporting the claim.
Name the person, setting, date, input and decision rule that could change its meaning.
Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Distinguish Missing Items From Missed Assessments”: 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, psychology, rehabilitation, outcomes research, education research, health policy and patient-centred service design without promising a grade, admission, funding decision or job.

CHAPTER 11 OF 13

11. Prespecify Analysis and Interpretation

Back to contents

Why this move matters

State analysis population, model, covariates, multiplicity, responder thresholds, sensitivity analyses and how practical meaning will be judged.

Did You Know? Statistical significance and meaningful change answer different questions.

Turn patient experience into a protocol decision

State analysis population, model, covariates, multiplicity, responder thresholds, sensitivity analyses and how practical meaning will be judged. Connect the concept or domain to an instrument, respondent, schedule, analysis metric and principal time point before recruitment begins.

Walk through one planned assessment

Use The protocol reports the mean difference and a responder analysis based on a cited threshold. Trace invitation, language and mode, completion, scoring, reminders, missed items, missed assessments, analysis and interpretation as planned rather than reconstructed after results.

Protect the people least likely to respond

Prespecify without pretending certainty

A threshold may vary by population and purpose. A complete protocol reduces avoidable ambiguity and research waste, but it cannot guarantee retention, valid measurement in every subgroup or a meaningful treatment effect.

Practical reader check

Point to the exact source or method sentence supporting the claim.
Name the person, setting, date, input and decision rule that could change its meaning.
Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Prespecify Analysis and Interpretation”: 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, psychology, rehabilitation, outcomes research, education research, health policy and patient-centred service design without promising a grade, admission, funding decision or job.

CHAPTER 12 OF 13

12. Plan Monitoring, Harms and Protocol Changes

Back to contents

Why this move matters

Explain PRO-related burden or distress monitoring, data-quality review and how amendments will be dated and justified.

Did You Know? Patient-reported data can reveal benefit, burden and harm.

Turn patient experience into a protocol decision

Explain PRO-related burden or distress monitoring, data-quality review and how amendments will be dated and justified. Connect the concept or domain to an instrument, respondent, schedule, analysis metric and principal time point before recruitment begins.

Walk through one planned assessment

Use A distress response triggers a support route without silently changing the outcome definition. Trace invitation, language and mode, completion, scoring, reminders, missed items, missed assessments, analysis and interpretation as planned rather than reconstructed after results.

Protect the people least likely to respond

Prespecify without pretending certainty

Monitoring must not become unblinded outcome fishing. A complete protocol reduces avoidable ambiguity and research waste, but it cannot guarantee retention, valid measurement in every subgroup or a meaningful treatment effect.

Practical reader check

Point to the exact source or method sentence supporting the claim.
Name the person, setting, date, input and decision rule that could change its meaning.
Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Plan Monitoring, Harms and Protocol Changes”: 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, psychology, rehabilitation, outcomes research, education research, health policy and patient-centred service design without promising a grade, admission, funding decision or job.

CHAPTER 13 OF 13

13. Make PRO Documents and Dissemination Routes Visible

Back to contents

Why this move matters

State where instruments, schedules, analysis plans, amendments and participant-facing results will be accessible.

Did You Know? Transparent protocol materials help compare planned and reported outcomes.

Turn patient experience into a protocol decision

State where instruments, schedules, analysis plans, amendments and participant-facing results will be accessible. Connect the concept or domain to an instrument, respondent, schedule, analysis metric and principal time point before recruitment begins.

Walk through one planned assessment

Use The protocol links versioned instruments and commits to a plain-language results summary. Trace invitation, language and mode, completion, scoring, reminders, missed items, missed assessments, analysis and interpretation as planned rather than reconstructed after results.

Protect the people least likely to respond

Prespecify without pretending certainty

Access restrictions may be legitimate but should be stated. A complete protocol reduces avoidable ambiguity and research waste, but it cannot guarantee retention, valid measurement in every subgroup or a meaningful treatment effect.

Practical reader check

Point to the exact source or method sentence supporting the claim.
Name the person, setting, date, input and decision rule that could change its meaning.
Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Make PRO Documents and Dissemination Routes Visible”: 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, psychology, rehabilitation, outcomes research, education research, health policy and patient-centred service design without promising a grade, admission, funding decision or job.

PRACTICE LAB

Build a patient-reported outcome protocol decision trail

Student route

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

Parent or teacher route

Ask the learner to explain SPIRIT-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 SPIRIT-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.

Decision rule

If a shorter explanation removes the condition that made the original claim true, it is not clearer yet. Restore the condition.

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 CONSORT-PRO trial-results guide for a related but different reader job. Return here when the question is specifically how to plan the patient voice before the first participant is asked to answer. 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 SPIRIT-PRO?

An extension for planning patient-reported outcomes in clinical trial protocols.

How many items does it contain?

Sixteen: 11 extensions and five elaborations.

Does it replace SPIRIT?

No. It is used with the main SPIRIT guidance.

Is it the same as CONSORT-PRO?

No. SPIRIT-PRO is for protocols; CONSORT-PRO is for completed trial reports.

What is the difference between a missing item and a missed assessment?

A missing item is one unanswered question within a form; a missed assessment means the whole scheduled measure is absent.

Can a protocol prevent all missing data?

No, but it can reduce avoidable missingness and prespecify honest handling.

PRIMARY SOURCES

Read the original SPIRIT-PRO guidance

Facts were checked against original publications and official records on 5 November 2026. Follow the live source for later corrections, completed updates or companion material.

A cheerful final note

Precise English makes reporting with SPIRIT-PRO more useful and more generous, not less. People can see how their evidence and values entered the work, where disagreement remains and what a responsible next step looks like.

Return to article contents