Sync template from atomicqms-style deployment
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Forms/Scoring/.gitkeep
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Forms/Scoring/.gitkeep
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Forms/Scoring/FRM-SCR-001-Scoring-Algorithm-Template.md
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Forms/Scoring/FRM-SCR-001-Scoring-Algorithm-Template.md
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# Scoring Algorithm Documentation
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| Form ID | SCR-XXX |
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|---------|-------------|
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| Measure Name | |
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| Measure Version | |
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| Algorithm Version | 1.0 |
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| Effective Date | [DATE] |
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| Author | [AUTHOR] |
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| Approved By | [APPROVER] |
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---
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## 1. Measure Overview
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| Field | Information |
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|-------|-------------|
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| Full Measure Name | |
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| Measure Type | ☐ PRO ☐ ClinRO ☐ ObsRO ☐ PerfO |
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| Copyright Holder | |
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| License Status | |
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| Number of Items | |
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| Subscales | |
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| Recall Period | |
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| Administration Time | |
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## 2. Item Response Coding
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### Response Format
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☐ Likert Scale
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☐ Visual Analog Scale (VAS)
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☐ Binary (Yes/No)
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☐ Numeric Rating Scale
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☐ Other: _____________________
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### Item Coding Table
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| Item Number | Item Content Summary | Response Options | Numeric Coding | Reverse Scored |
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|-------------|---------------------|------------------|----------------|----------------|
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| 1 | | | | ☐ Yes ☐ No |
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| 2 | | | | ☐ Yes ☐ No |
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| 3 | | | | ☐ Yes ☐ No |
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| 4 | | | | ☐ Yes ☐ No |
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| 5 | | | | ☐ Yes ☐ No |
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[Continue for all items]
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## 3. Scoring Procedures
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### 3.1 Item-Level Scoring
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#### Step 1: Code Raw Responses
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- Convert response selections to numeric values per coding table
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- For VAS items: measure distance from anchor (usually in mm, 0-100)
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- For open-ended items: follow specific coding instructions
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#### Step 2: Reverse Score Items (if applicable)
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**Reverse-Scored Items:** [List item numbers]
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**Reverse Scoring Formula:**
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- For X-point scale: Reversed Score = (X + 1) - Raw Score
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- Example for 5-point scale: Reversed Score = 6 - Raw Score
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#### Step 3: Handle Missing Data
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**Missing Data Rules:**
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☐ **Prorated Scoring:** If ≥ ___% of items completed, prorate missing values
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Formula: Scale Score = (Sum of completed items / Number of completed items) × Number of items in scale
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☐ **Person-Specific Mean Substitution:** Replace missing with person's mean on completed items
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☐ **No Imputation:** Score only if all items completed
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☐ **Copyright Holder Specified Rule:** ________________________________
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**Maximum Allowable Missing Data:**
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- Total scale: _____ items or _____%
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- Per subscale: _____ items or _____%
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### 3.2 Subscale Scoring
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| Subscale Name | Items Included | Scoring Formula | Possible Range | Higher Score Means |
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|---------------|----------------|-----------------|----------------|-------------------|
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| | | | | |
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| | | | | |
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| | | | | |
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**Subscale Calculation Steps:**
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1. Sum or average item scores per subscale
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2. Apply any subscale-specific transformations
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3. Round to _____ decimal places (specify)
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### 3.3 Total Score Calculation
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**Total Score Formula:**
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________________________________________________________________
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**Calculation Method:**
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☐ Sum of all items
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☐ Average of all items
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☐ Sum of subscales
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☐ Weighted sum: ______________________________________________
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☐ Other: ____________________________________________________
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**Possible Score Range:** Minimum: _____ Maximum: _____
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### 3.4 Transformations (if applicable)
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☐ **Linear Transformation**
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Formula: Transformed Score = ___________________________________
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☐ **T-Score Transformation**
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Formula: T = 50 + 10 × (Raw Score - Mean) / SD
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Population norms: Mean = _____ SD = _____
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☐ **Percentile Conversion**
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Reference normative data: _____________________________________
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☐ **IRT-Based Scoring**
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Scoring method: _______________________________________________
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Scoring software/table: ________________________________________
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## 4. Score Interpretation
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### 4.1 Descriptive Statistics
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**General Population Norms:**
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- Mean: _____
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- Standard Deviation: _____
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- Median: _____
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- Range: _____
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**Clinical Population Norms:**
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- Mean: _____
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- Standard Deviation: _____
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### 4.2 Clinical Cutoffs
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| Score Range | Severity Level | Clinical Interpretation |
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|-------------|---------------|------------------------|
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| | None/Minimal | |
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| | Mild | |
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| | Moderate | |
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| | Severe | |
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### 4.3 Minimal Clinically Important Difference (MCID)
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**Distribution-Based Estimates:**
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- 0.5 SD = _____
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- 1 SEM = _____
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**Anchor-Based Estimates:**
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- Based on [anchor]: MCID = _____
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- 95% CI: [_____ to _____]
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**Recommended MCID for Clinical Use:** _____
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Reference: ________________________________________________________
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### 4.4 Subscale Interpretation
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**Subscale 1: [Name]**
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- Score range: _____ to _____
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- Interpretation: ______________________________________________
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**Subscale 2: [Name]**
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- Score range: _____ to _____
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- Interpretation: ______________________________________________
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## 5. Quality Control Checks
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### 5.1 Data Quality Flags
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☐ All items within valid range
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☐ Required items completed
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☐ Logical consistency checks passed
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☐ Response patterns not suspicious (e.g., all same value)
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☐ Missing data within acceptable limits
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### 5.2 Common Scoring Errors to Avoid
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- [ ] Forgetting to reverse score applicable items
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- [ ] Incorrect handling of missing data
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- [ ] Using wrong subscale item groupings
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- [ ] Misinterpreting response codes
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- [ ] Applying transformations incorrectly
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- [ ] Using outdated scoring algorithms
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## 6. Implementation
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### 6.1 Manual Scoring
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**Required Materials:**
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- Completed measure form
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- Scoring template/worksheet
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- Calculator
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- Reverse scoring reference
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**Estimated Time:** _____ minutes per assessment
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### 6.2 Automated Scoring
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**Available Software/Systems:**
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- [ ] REDCap scoring module
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- [ ] eCOA platform automated scoring
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- [ ] Statistical software (SAS/R/SPSS) script
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- [ ] Excel scoring template
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- [ ] Copyright holder proprietary software
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- [ ] Other: _____________________
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**Software Version:** _____________
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**Validation Status:** ☐ Validated against manual scoring ☐ Not validated
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### 6.3 eCOA Considerations
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☐ Real-time scoring at completion
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☐ Delayed scoring after data review
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☐ Immediate feedback to participant: ☐ Yes ☐ No
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☐ Score visibility to clinician: ☐ Yes ☐ No
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## 7. Documentation Requirements
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### 7.1 Scoring Records
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For each completed measure, maintain:
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- [ ] Original completed measure form (source document)
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- [ ] Scoring worksheet if manual scoring
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- [ ] Computed scores (all subscales and total)
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- [ ] Missing data documentation
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- [ ] Quality control verification
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- [ ] Scorer name/ID and date
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### 7.2 Algorithm Updates
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**Version Control:**
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- Document all changes to scoring algorithm
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- Maintain version history
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- Specify effective date for each version
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- Map to measure version
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- Obtain copyright holder approval if required
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## 8. References
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**Primary Source:**
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[Measure developer's manual or primary publication]
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**Validation Evidence:**
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[Key validation publications]
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**Normative Data:**
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[Sources for population norms]
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**MCID Evidence:**
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[Publications establishing MCID]
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## 9. Contact Information
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**For Scoring Questions:**
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[Internal expert contact]
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**Copyright Holder Support:**
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[Copyright holder contact information]
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---
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## Revision History
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| Version | Date | Changes | Approved By |
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||||
|---------|------|---------|-------------|
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| 1.0 | [DATE] | Initial release | [APPROVER] |
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---
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**Related Documents:**
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- SOP-ADM-001: Clinical Outcome Measure Administration
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- WI-XXX: [Measure-Specific Work Instruction]
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- License Agreement: [License number]
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