Psychometric Validation Study Protocol
| Form ID |
FRM-VAL-001 |
| Form Title |
Psychometric Validation Study Protocol |
| Version |
1.0 |
| Effective Date |
[DATE] |
1. Study Identification
| Field |
Information |
| Protocol Title |
|
| Protocol Number |
|
| Protocol Version |
|
| Protocol Date |
|
| Principal Investigator |
|
| Biostatistician |
|
| Sponsor |
|
2. Outcome Measure Information
| Field |
Information |
| Measure Name |
|
| Measure Type |
☐ PRO ☐ ClinRO ☐ ObsRO ☐ PerfO |
| Version/Form |
|
| Number of Items |
|
| Subscales |
|
| Recall Period |
|
| Response Format |
|
| Copyright Status |
|
| License Status |
|
3. Background and Rationale
3.1 Construct Being Measured
[Describe the concept or construct the measure assesses]
3.2 Target Population
[Define the intended respondent population]
3.3 Intended Use
[Describe how the measure will be used - e.g., clinical trials endpoint, clinical assessment, screening tool]
3.4 Rationale for Validation Study
[Explain why validation is needed - new measure, new population, new context, etc.]
3.5 Existing Evidence
[Summarize any existing validation evidence]
4. Validation Objectives
4.1 Primary Objectives
☐ Assess reliability
- ☐ Internal consistency
- ☐ Test-retest reliability
- ☐ Inter-rater reliability
☐ Assess validity
- ☐ Content validity
- ☐ Construct validity (convergent/discriminant)
- ☐ Known-groups validity
- ☐ Criterion validity
☐ Assess responsiveness
- ☐ Sensitivity to change
- ☐ Minimal clinically important difference (MCID)
☐ Assess interpretability
- ☐ Score distributions
- ☐ Floor/ceiling effects
- ☐ Clinical cutoffs
4.2 Secondary Objectives
5. Study Design
| Design Element |
Description |
| Study Type |
☐ Cross-sectional ☐ Longitudinal ☐ Test-retest ☐ Other: _____ |
| Number of Timepoints |
|
| Duration of Follow-up |
|
| Study Settings |
|
6. Study Population
6.1 Inclusion Criteria
-
-
-
-
6.2 Exclusion Criteria
-
-
-
-
7. Sample Size
7.1 Reliability Analyses
| Analysis |
Minimum N |
Target N |
Rationale |
| Internal Consistency |
|
|
|
| Test-Retest |
|
|
|
| Inter-Rater |
|
|
|
7.2 Validity Analyses
| Analysis |
Minimum N |
Target N |
Rationale |
| Factor Analysis |
|
|
|
| Known-Groups |
|
|
|
| Convergent Validity |
|
|
|
7.3 Responsiveness Analyses
| Analysis |
Minimum N |
Target N |
Rationale |
| Change Over Time |
|
|
|
| MCID Determination |
|
|
|
8. Comparison Measures
8.1 For Construct Validity
| Measure Name |
Construct Assessed |
Expected Correlation |
Rationale |
|
|
Convergent (r ≥ 0.50) |
|
|
|
Discriminant (r < 0.30) |
|
|
|
|
|
8.2 For Criterion Validity
| Criterion Measure |
Type |
Expected Agreement |
Rationale |
|
☐ Gold Standard ☐ Anchor |
|
|
8.3 For Responsiveness
| Anchor Measure |
Purpose |
Expected Correlation |
Rationale |
|
Patient global rating |
|
|
|
Clinician global rating |
|
|
9. Data Collection Schedule
| Timepoint |
Window |
Measures to Administer |
Purpose |
| Baseline |
|
|
|
|
|
|
|
|
|
|
|
10. Administration Procedures
10.1 Training Requirements
10.2 Administration Mode
☐ Self-administered paper
☐ Interviewer-administered
☐ Electronic (eCOA)
☐ Other: _____________________
10.3 Administration Order
11. Statistical Analysis Plan
11.1 Reliability Analyses
Internal Consistency
- Cronbach's alpha (target ≥ 0.70)
- Item-total correlations
- Factor analysis (exploratory or confirmatory)
Test-Retest Reliability
- Intraclass correlation coefficient (target ≥ 0.70)
- Standard error of measurement
- Bland-Altman plots
- Time between assessments: __________
Inter-Rater Reliability (if applicable)
- ICC or weighted kappa (target ≥ 0.70)
- Percent agreement
11.2 Validity Analyses
Construct Validity
- Convergent validity: Pearson correlations (target r ≥ 0.50)
- Discriminant validity: Pearson correlations (target r < 0.30)
- Confirmatory factor analysis: CFI > 0.90, RMSEA < 0.08
- Known-groups validity: t-tests or ANOVA with effect sizes
Content Validity (if applicable)
- Qualitative methods
- Sample size: __________
- Analysis approach: ___________________________________
11.3 Responsiveness Analyses
- Effect sizes: Cohen's d, standardized response mean
- Correlation with change in anchors
- ROC analysis for MCID
- Distribution-based methods: 0.5 SD, 1 SEM
11.4 Interpretability Analyses
- Floor/ceiling effects (>15% at extremes)
- Score distributions (mean, SD, skewness, kurtosis)
- Clinical cutoffs (if applicable)
- Normative data (if applicable)
11.5 Missing Data Handling
Strategy: ___________________________________________________
11.6 Software
☐ SAS Version: __________
☐ R Version: __________
☐ SPSS Version: __________
☐ Mplus Version: __________
☐ Other: ________________
12. Success Criteria
[Define criteria for considering the measure adequately validated]
| Measurement Property |
Success Criterion |
| Internal Consistency |
|
| Test-Retest Reliability |
|
| Construct Validity |
|
| Responsiveness |
|
13. Timeline
| Milestone |
Target Date |
Responsible |
| Protocol finalization |
|
|
| Ethics approval |
|
|
| Participant recruitment start |
|
|
| Baseline data collection complete |
|
|
| Follow-up data collection complete |
|
|
| Data analysis complete |
|
|
| Validation report draft |
|
|
| Validation report final |
|
|
14. Ethical Considerations
| Element |
Status/Details |
| IRB/Ethics Committee |
|
| IRB Protocol Number |
|
| Informed Consent |
☐ Required ☐ Waived |
| HIPAA Authorization |
☐ Required ☐ Not applicable |
15. Data Management
| Element |
Specification |
| Database System |
|
| Data Entry Method |
☐ Single ☐ Double |
| Quality Control Procedures |
|
| Data Storage Location |
|
| Data Retention Period |
|
Protocol Signatures
| Role |
Name |
Signature |
Date |
| Principal Investigator |
|
|
|
| Biostatistician |
|
|
|
| Quality Manager |
|
|
|
Related Documents:
- SOP-VAL-001: Psychometric Validation of Clinical Outcome Measures
- FRM-VAL-002: Psychometric Validation Report Template
- SOP-DM-001: Data Management for Validation Studies
