# Alpha-Stim AID × Major depression at 16 weeks — Evidence checklist

Verdict 2952 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-08-26  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-11

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- Population: Major-depression population in English primary care; detailed selection conditions unverified
- Ingredient, formulation and route: Alpha-Stim AID; only the original 8-week study-exposure wording is preserved
- Dose: Not recorded
- Comparator: Sham; detailed configuration and common treatment unverified
- Measured outcome: 16-week GRID-HDRS-17 change; adjusted active-minus-sham difference
- Duration: Distinguish the 8-week study intervention from the 16-week assessment
- Questions outside this scope: Treating other devices/waveforms/indications, the 100 model in depression with anxiety at 5 weeks, or another-device trial with 30 treatment-resistant participants as direct replication of AID at 16 weeks; Attributing approximately 6-point within-arm improvement to added device efficacy, or calculating new effects, CIs or response rates from the original changes; Automatically substituting 200/236 observations, original 15.3% missingness or 118/118 allocation for actual ITT or safety denominators; Converting original exclusion of the 3-point threshold, D30 or R0/I1 into new equivalence, an entire-device-class null claim, or independence/safety certification; Converting the historical £500 wording into a current price or product recommendation; Adding the same bibliography, participants, groups, time points, sibling sheets, outcomes or later analyses as new independent trials/participants; Converting original registration wording of unverified, historical absence before the registration system or not applicable into an actual registration identifier or current confirmation of absent registration; Inheriting parent score/axes or historical cross-checking as subclaim score, current content review or external reading; New numeric calculations, invented values, effects/CIs, grades, independence certification or treatment/device-use/training instructions

## Checklist items

### N01 · Which original question and verdict are preserved?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The selected question is “Alpha-Stim AID efficacy at 16 weeks in major depression”. Its original D grade and “Null in the large sham-controlled trial” note are preserved. The parent D grade, 30 points and axes provide parent context.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. The subclaim has no score, status or axes keys; parent values do not fill them. Review of the existing content remains incomplete.
- Reason for missing information: The subclaim has no score, status or axes keys; parent values do not fill them.
- Required materials and conditions: Separate the selected subclaim from the parent verdict, score and axes
- Materials to obtain first: Correction records for the selected subclaim or parent text
- Further research: If the text changes, update the selected question link and parent context separately. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Separate the selected subclaim from the parent verdict, score and axes are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Separate the selected subclaim from the parent verdict, score and axes and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design
- Related sources: S01, S02, S03

### N02 · Which major-depression population was actually studied?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original description identifies a major-depression trial at 25 English primary-care sites. This summary lacks detailed ages, diagnostic procedures, baseline severity and exclusion criteria.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. The population cannot be confirmed as equivalent to depression with anxiety or treatment-resistant depression. Review of the existing content remains incomplete.
- Reason for missing information: The population cannot be confirmed as equivalent to depression with anxiety or treatment-resistant depression.
- Required materials and conditions: Diagnosis, age, severity, selection/exclusion and recruitment setting
- Materials to obtain first: Alpha-Stim-D recruitment criteria and baseline-characteristics table
- Further research: If direct results for particular populations are provided, distinguish their applicable scope. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Diagnosis, age, severity, selection/exclusion and recruitment setting are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Diagnosis, age, severity, selection/exclusion and recruitment setting and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap's own design
- Related sources: S01

### N03 · Which device model was tested, and is it equivalent to other CES devices?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The pivotal trial used Alpha-Stim AID. The original text limits generalization to all cranial electrotherapy devices with different waveforms, currents or electrodes. S02 used Alpha-Stim 100; S03 used another device.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Exact equivalence or compatibility between AID and 100, and the S03 model identity, are unverified. Review of the existing content remains incomplete.
- Reason for missing information: Exact equivalence or compatibility between AID and 100, and the S03 model identity, are unverified.
- Required materials and conditions: Identity of the AID model, waveform, electrodes and device configuration
- Materials to obtain first: Trial-device specifications and product identity for each report
- Further research: Link different device reports by model and indication. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Identity of the AID model, waveform, electrodes and device configuration are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Identity of the AID model, waveform, electrodes and device configuration and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.2–3.2.3; direction markers and adaptation for diagnostic questions are our own design; M04 §4.6.1–4.6.2, M15 §15.3.1; our own application
- Related sources: S01, S02, S03

### N04 · How do study exposure and the assessment time differ?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original study exposure was recorded as 100 μA at 0.5 Hz for 1 hour daily over 8 weeks; the selected outcome is at 16 weeks. This describes historical study exposure and is not a device-use instruction.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Actual cumulative exposure, use after discontinuation, adherence by arm and intervention after 8 weeks are unverified. Review of the existing content remains incomplete.
- Reason for missing information: Actual cumulative exposure, use after discontinuation, adherence by arm and intervention after 8 weeks are unverified.
- Required materials and conditions: Study-intervention duration, exposure records and endpoint time
- Materials to obtain first: Exposure, adherence and discontinuation records and the 16-week assessment schedule
- Further research: Track actual study exposure and observation times separately. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Study-intervention duration, exposure records and endpoint time are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Study-intervention duration, exposure records and endpoint time and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.2–3.2.3; direction markers and adaptation for diagnostic questions are our own design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is our own design; M03 §3.2.3, M08 §8.2.2–8.2.3; our own application
- Related sources: S01

### N05 · What actually differed between active and sham devices?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The pivotal report describes a sham-controlled RCT. The adjusted difference is explicitly active minus sham.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Exact sham output and sensation, common treatment and changes by arm are unverified in this summary. Review of the existing content remains incomplete.
- Reason for missing information: Exact sham output and sensation, common treatment and changes by arm are unverified in this summary.
- Required materials and conditions: Active/sham configuration, sensation, concomitant treatment and comparison direction
- Materials to obtain first: Active/sham specifications and concomitant-treatment table
- Further research: If comparison details are obtained, distinguish added device contributions from accompanying changes. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Active/sham configuration, sensation, concomitant treatment and comparison direction are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Active/sham configuration, sensation, concomitant treatment and comparison direction and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application
- Related sources: S01

### N06 · How are randomization and concealment recorded?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The preserved description states that 236 participants were randomized, 118 per arm, through an independent web system.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Details of sequence generation, operational concealment and baseline balance by arm have not been read. Review of the existing content remains incomplete.
- Reason for missing information: Details of sequence generation, operational concealment and baseline balance by arm have not been read.
- Required materials and conditions: Allocation method, concealment and baseline balance
- Materials to obtain first: Original allocation-method description and baseline-characteristics table
- Further research: If methods material is provided, link allocation information relevant to the selected outcome. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Allocation method, concealment and baseline balance are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Allocation method, concealment and baseline balance and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 §8.1–8.2.3; own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design
- Related sources: S01

### N07 · Who was masked, and is masking success known?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original description of participant, outcome-assessor and data-analyst masking is preserved.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Device operators’ roles, evaluation of masking success and measurement differences by arm are unverified. Review of the existing content remains incomplete.
- Reason for missing information: Device operators’ roles, evaluation of masking success and measurement differences by arm are unverified.
- Required materials and conditions: Participant, assessor and analyst masking and measurement procedures
- Materials to obtain first: Masking and assessment-operation records
- Further research: Record unresolved masking information separately from actual measurement limitations. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Participant, assessor and analyst masking and measurement procedures are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Participant, assessor and analyst masking and measurement procedures and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 Table 8.2.a, M03 §3.2.4; internal application
- Related sources: S01

### N08 · What outcome does 16-week GRID-HDRS-17 represent?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The selected outcome is change in GRID-HDRS-17 at 16 weeks. Values for other times, other depression scales, remission or functional outcomes do not replace it.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Detailed scale-assessment procedures, baseline values and variance by arm are unverified in this summary. Review of the existing content remains incomplete.
- Reason for missing information: Detailed scale-assessment procedures, baseline values and variance by arm are unverified in this summary.
- Required materials and conditions: Scale definition, units, direction, assessment method and time
- Materials to obtain first: Scale-measurement methods and the 16-week results table
- Further research: Attribute definitions and analyses to their respective endpoints. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Scale definition, units, direction, assessment method and time are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Scale definition, units, direction, assessment method and time and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application
- Related sources: S01

### N09 · Are changes within each arm distinguished from between-arm differences?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: At 16 weeks, change was −5.9 points with active treatment and −6.5 with sham. The original text did not attribute the approximately 6-point improvement in both arms to an added device effect.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Confidence intervals, variance, denominators and the change model for each arm are unverified. No new between-arm difference is calculated from these values. Review of the existing content remains incomplete.
- Reason for missing information: Confidence intervals, variance, denominators and the change model for each arm are unverified. No new between-arm difference is calculated from these values.
- Required materials and conditions: Separate arm-specific changes from the comparative estimate
- Materials to obtain first: Arm-specific change table and comparative model
- Further research: Preserve within-arm improvement separately from the active-minus-sham effect. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Separate arm-specific changes from the comparative estimate are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Separate arm-specific changes from the comparative estimate and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 §8.2.2, M15 §15.3.1; our own application
- Related sources: S01

### N10 · What are the adjusted between-arm estimate, CI and P value?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original adjusted active-minus-sham difference of +0.6 points, 95% CI −1.0 to 2.2, P=0.46 is preserved.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Adjustment variables, model, variance and arm-specific analysis denominators are unverified. No new effect estimate or CI is calculated. Review of the existing content remains incomplete.
- Reason for missing information: Adjustment variables, model, variance and arm-specific analysis denominators are unverified. No new effect estimate or CI is calculated.
- Required materials and conditions: Comparison direction, adjustment model, denominator and original estimate
- Materials to obtain first: Adjusted-analysis table and SAP
- Further research: Link the original estimate and interval to their analysis. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Comparison direction, adjustment model, denominator and original estimate are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Comparison direction, adjustment model, denominator and original estimate and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 §8.2.2, M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design
- Related sources: S01

### N11 · How are the prespecified 3-point threshold and original interpretation preserved?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original text states that the paper declared a between-arm GRID-HDRS-17 difference of at least 3 points clinically important, and the observed CI did not reach −3 points in favor of active treatment.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. The criterion’s basis and actual advance-planning documents have not been read. The original interpretation is preserved without a new equivalence claim, zero-effect claim or clinical certification. Review of the existing content remains incomplete.
- Reason for missing information: The criterion’s basis and actual advance-planning documents have not been read. The original interpretation is preserved without a new equivalence claim, zero-effect claim or clinical certification.
- Required materials and conditions: Important-difference criterion, timing of its specification and interpretation scope
- Materials to obtain first: Threshold rationale, registration, protocol and SAP
- Further research: Distinguish the prespecified importance criterion from its relationship to newly supplied analyses. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Important-difference criterion, timing of its specification and interpretation scope are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Important-difference criterion, timing of its specification and interpretation scope and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application
- Related sources: S01

### N12 · Are allocation, 16-week observation and missingness distinguished?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original 236 randomized, 118 allocated per arm, 200/236 observed at 16 weeks and 15.3% missingness are preserved.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Observed and missing counts, reasons and timing by arm are unverified. No new missing count or percentage is calculated. Review of the existing content remains incomplete.
- Reason for missing information: Observed and missing counts, reasons and timing by arm are unverified. No new missing count or percentage is calculated.
- Required materials and conditions: Allocation and observation denominators, missingness by arm and reasons
- Materials to obtain first: Flow diagram and arm-specific observation/missingness tables
- Further research: Link allocation and observation denominators to each outcome. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Allocation and observation denominators, missingness by arm and reasons are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Allocation and observation denominators, missingness by arm and reasons and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design
- Related sources: S01

### N13 · Does the ITT description adequately explain the actual analysis?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original text describes ITT analysis. The 200/236 observations at 16 weeks are not assumed to equal the ITT-analysis denominator.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Imputation, model assumptions about missingness, the actual analysis denominator and sensitivity results are unverified. Review of the existing content remains incomplete.
- Reason for missing information: Imputation, model assumptions about missingness, the actual analysis denominator and sensitivity results are unverified.
- Required materials and conditions: Effect of interest, missing-data handling, model and sensitivity analyses
- Materials to obtain first: ITT-analysis description, SAP and sensitivity results
- Further research: Distinguish an analysis of observed participants from estimation of the effect of assignment. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Effect of interest, missing-data handling, model and sensitivity analyses are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Effect of interest, missing-data handling, model and sensitivity analyses and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.
- Related sources: S01

### N14 · Were endpoints, analyses and times compared with the plans?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original registration field contains ISRCTN11853110. The 16-week GRID outcome and prespecified 3-point wording are linked to the summary.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Registration, protocol, SAP and amendment history have not been read or accessed in this production. An identifier does not establish completed comparison with plans. Review of the existing content remains incomplete.
- Reason for missing information: Registration, protocol, SAP and amendment history have not been read or accessed in this production. An identifier does not establish completed comparison with plans.
- Required materials and conditions: Registration, protocol and SAP alongside reported outcomes
- Materials to obtain first: Registration history, protocol, and SAP
- Further research: If planning material is provided, record changes to endpoints, analyses and times separately. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Registration, protocol and SAP alongside reported outcomes are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Registration, protocol and SAP alongside reported outcomes and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M04 §4.5–4.6 principles for collecting and selecting materials; separation of access and reading and hyperlink rules are Chamgap's own design
- Related sources: S01

### N15 · Are concomitant treatment, adherence and treatment changes known by arm?

Verification status: Unverified  
Reading scope: Summary read; external material unread

- Current findings: The active/sham comparison and 8-week study-exposure wording are preserved.
- Why unverified: The currently required information is unverified in the stored summary. Medication, counselling, other treatment, actual adherence, discontinuation, changes and their analytical handling by arm are unverified in this summary. Review of the existing content remains incomplete.
- Reason for missing information: Medication, counselling, other treatment, actual adherence, discontinuation, changes and their analytical handling by arm are unverified in this summary.
- Required materials and conditions: Arm-specific antidepressant treatment, counselling, adherence and rescue-treatment records
- Materials to obtain first: Concomitant-treatment, adherence, deviation and treatment-change tables
- Further research: Link material that distinguishes common treatment from added device contributions. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Arm-specific antidepressant treatment, counselling, adherence and rescue-treatment records are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Arm-specific antidepressant treatment, counselling, adherence and rescue-treatment records and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation
- Related sources: S01

### N16 · How are safety review and early stopping recorded?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original description states that a safety-review structure existed, but 16-week assessment was completed without early stopping after a boundary was reached.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Stopping-boundary values, committee decisions and interim-analysis documents have not been read. Absence of early stopping does not establish efficacy or safety. Review of the existing content remains incomplete.
- Reason for missing information: Stopping-boundary values, committee decisions and interim-analysis documents have not been read. Absence of early stopping does not establish efficacy or safety.
- Required materials and conditions: Original description of review structure, stopping boundaries and completed follow-up
- Materials to obtain first: Review plans and interim/final decision records
- Further research: Record advance plans separately from actual stopping. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Original description of review structure, stopping boundaries and completed follow-up are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Original description of review structure, stopping boundaries and completed follow-up and linking required and currently available materials for the selected question.
- Application exceptions: Supplement safety-information gaps for the selected subclaim. Depressive-symptom results or parent safety wording do not establish safety, harm incidence or new device-use instructions.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 Table 8.2.a, M04 §4.6.3; our own application; M19 §19.1.2–19.2.4; our own application; M19 §19.1.2–19.2.4, M04 §4.6.3; our own application
- Related sources: S01

### N17 · What was the actual scope of NIHR support?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original wording on NIHR ARC East Midlands support and mixed NIHR/EPI support is preserved.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. NIHR-funded items, amounts, contracts, disbursement and detailed roles are unverified. Review of the existing content remains incomplete.
- Reason for missing information: NIHR-funded items, amounts, contracts, disbursement and detailed roles are unverified.
- Required materials and conditions: Funding providers, supported items and roles
- Materials to obtain first: Funding disclosures and support contracts
- Further research: Distinguish support sources, roles and product support. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Funding providers, supported items and roles are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Funding providers, supported items and roles and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.
- Related sources: S01

### N18 · Which costs and devices did EPI provide?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original record states that EPI provided excess treatment and health-economic evaluation costs and active/sham devices.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Amounts by item, conditions of provision and the full extent of additional support are unverified. Review of the existing content remains incomplete.
- Reason for missing information: Amounts by item, conditions of provision and the full extent of additional support are unverified.
- Required materials and conditions: Manufacturer cash/cost support, product provision and scope of influence
- Materials to obtain first: Original product/cost-support disclosures
- Further research: Support alone does not justify excluding the result or certifying independence. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Manufacturer cash/cost support, product provision and scope of influence are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Manufacturer cash/cost support, product provision and scope of influence and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.
- Related sources: S01

### N19 · Which roles does the no-involvement declaration cover?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The preserved text states that the protocol declared two companies had no involvement in design, collection, analysis, interpretation or writing. The original English also says “companies”.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. The original protocol, the second company’s identity and independent comparison with actual roles are unverified. The declaration is not a new certification of independence. Review of the existing content remains incomplete.
- Reason for missing information: The original protocol, the second company’s identity and independent comparison with actual roles are unverified. The declaration is not a new certification of independence.
- Required materials and conditions: Role disclosures for design, collection, analysis, interpretation and writing
- Materials to obtain first: Protocol role disclosures and company-identity material
- Further research: Record declared non-involvement separately from the actual level of verification. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Role disclosures for design, collection, analysis, interpretation and writing are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Role disclosures for design, collection, analysis, interpretation and writing and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Chamgap’s own independence and attribution conditions. The official methodology sections used in this pilot do not guarantee every detail of these items; M08 Table 8.2.a, M04 §4.6.3; our own application
- Related sources: S01

### N20 · Are author employment, patents and analysis/publication support known?

Verification status: Unverified  
Reading scope: Summary read; external material unread

- Current findings: Only the preserved wording on manufacturer support and the no-involvement declaration is available.
- Why unverified: The currently required information is unverified in the stored summary. Detailed disclosures of employee authors, patents, individual COI, outsourced analysis and publication/writing costs are unverified. Review of the existing content remains incomplete.
- Reason for missing information: Detailed disclosures of employee authors, patents, individual COI, outsourced analysis and publication/writing costs are unverified.
- Required materials and conditions: Author affiliations, COI, external analysis and manuscript/publication support
- Materials to obtain first: Author/COI and analysis/publication-support material
- Further research: Link supplied disclosures item by item. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Author affiliations, COI, external analysis and manuscript/publication support are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Author affiliations, COI, external analysis and manuscript/publication support and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.
- Related sources: S01

### N21 · Does the 115-participant trial address the same AID question at 16 weeks?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The preserved context states that Barclay 2014 used Alpha-Stim 100 in 115 participants with depression and anxiety, reporting P=0.001 and d=0.78 on a depression scale at 5 weeks.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. The exact scale, denominator, CI, plan and equivalence to the AID/MDD/16-week conditions are unverified. It is not counted as replication of the identical direct question. Review of the existing content remains incomplete.
- Reason for missing information: The exact scale, denominator, CI, plan and equivalence to the AID/MDD/16-week conditions are unverified. It is not counted as replication of the identical direct question.
- Required materials and conditions: Agreements and differences in device, population, duration, scale and comparison
- Materials to obtain first: Barclay paper, device specifications and population/analysis tables
- Further research: Record comparison specifications separately by device, population and assessment time. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Agreements and differences in device, population, duration, scale and comparison are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Agreements and differences in device, population, duration, scale and comparison and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M04 §4.6.1–4.6.2, M15 §15.3.1; our own application; M03 §3.2.1; detailed population conditions are our own design; M03 §3.2.2–3.2.3; direction markers and adaptation for diagnostic questions are our own design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is our own design
- Related sources: S02

### N22 · Were registration and funding for the Barclay trial verified?

Verification status: Unverified  
Reading scope: Summary read; external material unread

- Current findings: Both S02 funding and registration fields originally say “Not confirmed”. That wording is preserved.
- Why unverified: The currently required information is unverified in the stored summary. Registration and funding/product/author disclosures are unverified. “Not confirmed” is neither a registration identifier nor evidence of no support or no registration. Review of the existing content remains incomplete.
- Reason for missing information: Registration and funding/product/author disclosures are unverified. “Not confirmed” is neither a registration identifier nor evidence of no support or no registration.
- Required materials and conditions: Actual registration identifier, support and COI
- Materials to obtain first: Original registration, funding and COI material for that trial
- Further research: If an actual identifier or disclosure is provided, distinguish it from the original wording. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Actual registration identifier, support and COI are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Actual registration identifier, support and COI and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Chamgap’s own independence/attribution conditions. The official methodological sections in this pilot do not warrant all these detailed items; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; material-collection/selection principles in M04 §4.5–4.6; separation of access/reading and the hyperlink contract are Chamgap design
- Related sources: S02

### N23 · What context does the 30-participant treatment-resistant-depression trial provide?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: S03 is a stored summary of a randomized trial with 30 participants with treatment-resistant major depression using another device, reporting a null depressive-symptom result.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Device model, comparison, duration, scale, denominators by arm and values/CIs are unverified. It does not become direct replication of the AID effect at 16 weeks. Review of the existing content remains incomplete.
- Reason for missing information: Device model, comparison, duration, scale, denominators by arm and values/CIs are unverified. It does not become direct replication of the AID effect at 16 weeks.
- Required materials and conditions: Population, device, duration, endpoint, denominator and quantitative results
- Materials to obtain first: S03 paper and population, device and analysis tables
- Further research: Preserve the conditions of reports involving other populations or devices. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Population, device, duration, endpoint, denominator and quantitative results are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Population, device, duration, endpoint, denominator and quantitative results and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M04 §4.6.1–4.6.2, M15 §15.3.1; our own application; M03 §3.2.1; detailed population conditions are our own design; M03 §3.2.2–3.2.3; direction markers and adaptation for diagnostic questions are our own design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is our own design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design
- Related sources: S03

### N24 · Are registration and support for the 30-participant trial known?

Verification status: Unverified  
Reading scope: Summary read; external material unread

- Current findings: S03 funding and registration originally say “Not confirmed”.
- Why unverified: The currently required information is unverified in the stored summary. Original registration, funding, products and author relationships are unverified. Unverified information is not converted to absence. Review of the existing content remains incomplete.
- Reason for missing information: Original registration, funding, products and author relationships are unverified. Unverified information is not converted to absence.
- Required materials and conditions: Registration identifier, support, product provision and COI
- Materials to obtain first: S03 registration and funding/COI material
- Further research: Record the actual status and identity of material obtained. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Registration identifier, support, product provision and COI are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Registration identifier, support, product provision and COI and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Chamgap’s own independence/attribution conditions. The official methodological sections in this pilot do not warrant all these detailed items; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; material-collection/selection principles in M04 §4.5–4.6; separation of access/reading and the hyperlink contract are Chamgap design
- Related sources: S03

### N25 · Are conflicting findings and the original replication limits preserved?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original text distinguishes the large precise null trial from earlier positive findings and a null trial of another device, and does not treat them as repeated refutation. The parent replication axis is R0.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. External identities, comparability across different conditions and the complete literature scope are unverified. No new repeated-refutation or entire-device-class null grade is produced. Review of the existing content remains incomplete.
- Reason for missing information: External identities, comparability across different conditions and the complete literature scope are unverified. No new repeated-refutation or entire-device-class null grade is produced.
- Required materials and conditions: Family-specific conditions, positive/null findings and original replication limits
- Materials to obtain first: Trial-condition tables and related-report links
- Further research: Distinguish direct replication of the same question within the scope of newly supplied material. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Family-specific conditions, positive/null findings and original replication limits are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Family-specific conditions, positive/null findings and original replication limits and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is our own design; M04 §4.6.1–4.6.2, M15 §15.3.1; our own application; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome linkage is our own application
- Related sources: S01, S02, S03

### N26 · How are duplicate reports, trials and participants handled?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Report records distinguish S01 as ISRCTN11853110/Alpha-Stim-D, S02 as Barclay 2014, and S03 as another-device trial in treatment-resistant depression. The numbers 236, 115 and 30 belong to their respective preserved reports.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. External paper identities, related reports and cohort overlap have not been compared. Report counts are not certified as unique independent-trial counts, and participants are not newly summed. Review of the existing content remains incomplete.
- Reason for missing information: External paper identities, related reports and cohort overlap have not been compared. Report counts are not certified as unique independent-trial counts, and participants are not newly summed.
- Required materials and conditions: Links from citations to trial families, outcomes and denominators
- Materials to obtain first: Trial-specific registrations and included/related-report tables
- Further research: Link citation, trial, population and time relationships separately. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Links from citations to trial families, outcomes and denominators are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Links from citations to trial families, outcomes and denominators and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application
- Related sources: S01, S02, S03

### N27 · What are the original adverse-event frequencies and their scope?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original text records adverse events in 9/118 (8%) active and 8/118 (7%) sham participants. Only these original frequencies are preserved.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Event-specific definitions, people-versus-event counts, exact collection period/method and between-arm CI are unverified. No new risk difference, ratio or safety verdict is created. Review of the existing content remains incomplete.
- Reason for missing information: Event-specific definitions, people-versus-event counts, exact collection period/method and between-arm CI are unverified. No new risk difference, ratio or safety verdict is created.
- Required materials and conditions: Event definitions, people/events by arm, period and collection method
- Materials to obtain first: Adverse-event tables by arm and collection plan
- Further research: Record efficacy and harm denominators, periods and observations separately. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Event definitions, people/events by arm, period and collection method are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Event definitions, people/events by arm, period and collection method and linking required and currently available materials for the selected question.
- Application exceptions: Supplement safety-information gaps for the selected subclaim. Depressive-symptom results or parent safety wording do not establish safety, harm incidence or new device-use instructions.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M19 §19.1.2–19.2.4; our own application; M19 §19.1.2–19.2.4; detailed distinctions are our own design; M19 §19.2.2–19.2.4, M03 §3.2.3; our own application; M19 §19.1.2–19.2.4; our own application
- Related sources: S01

### N28 · What is recorded about serious events and causal attribution?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original description records 1 hospitalization for suicidal ideation in the sham arm, judged unrelated to the device.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Event timing, baseline risk, concomitant treatment and original causal-assessment material have not been read. The original attribution is not extended to a new causal certification or absence of all harms. Review of the existing content remains incomplete.
- Reason for missing information: Event timing, baseline risk, concomitant treatment and original causal-assessment material have not been read. The original attribution is not extended to a new causal certification or absence of all harms.
- Required materials and conditions: Event identity, timing, concurrent exposure and attribution basis
- Materials to obtain first: Serious-event details and attribution basis
- Further research: Distinguish event reporting from the material actually supporting relatedness assessment. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Event identity, timing, concurrent exposure and attribution basis are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Event identity, timing, concurrent exposure and attribution basis and linking required and currently available materials for the selected question.
- Application exceptions: Supplement safety-information gaps for the selected subclaim. Depressive-symptom results or parent safety wording do not establish safety, harm incidence or new device-use instructions.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.2 design-specific harm questions; temporal-relationship details are Chamgap design; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool
- Related sources: S01

### N29 · Are 16-week findings extended to other durations, indications or overall safety?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original text treats other waveforms and indications as separate questions. The £500 price wording is historical private-sale context, not a current price or recommendation.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Sustained effects after 16 weeks, long-term/rare harms and direct results for other indications are unverified. Review of the existing content remains incomplete.
- Reason for missing information: Sustained effects after 16 weeks, long-term/rare harms and direct results for other indications are unverified.
- Required materials and conditions: Direct evidence for long-term outcomes, vulnerable groups and other devices/indications
- Materials to obtain first: Long-term follow-up and material on other devices/populations
- Further research: Separate the selected question from extended questions. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Direct evidence for long-term outcomes, vulnerable groups and other devices/indications are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Direct evidence for long-term outcomes, vulnerable groups and other devices/indications and linking required and currently available materials for the selected question.
- Application exceptions: Supplement safety-information gaps for the selected subclaim. Depressive-symptom results or parent safety wording do not establish safety, harm incidence or new device-use instructions.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap design; M03 §3.2.4; Chamgap extrapolation boundary; M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation
- Related sources: S01, S02, S03

### N30 · What history do dates, Korean/English text, empty corrections and cross-checking represent?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The full source preserves parent D30, axes, Korean/English text, 2026-08-26 and empty correction and deliberation fields. The past “Cross-check applied” label is historical.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. It does not indicate current external-source comparison, correction/retraction checking, language-original comparison or completed content review. Review of the existing content remains incomplete.
- Reason for missing information: It does not indicate current external-source comparison, correction/retraction checking, language-original comparison or completed content review.
- Required materials and conditions: Historical verdict date, language-specific wording, correction history and actual current actions
- Materials to obtain first: New correction records and user feedback
- Further research: Distinguish original records, change events and production versions. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Historical verdict date, language-specific wording, correction history and actual current actions are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Historical verdict date, language-specific wording, correction history and actual current actions and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are our own design
- Related sources: S01, S02, S03

### N31 · Which materials were actually read, and which links were only preserved?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The entire preserved JSON and its 3 evidence/citation summaries were read for production. Original external-paper URLs are retained; the materials table labels summaries “Summary read” and external material “Not read”.
- Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Abstracts/full texts, registrations, protocols, SAP and disclosure originals have not been read or accessed. A link does not establish full-text reading or successful access. Review of the existing content remains incomplete.
- Reason for missing information: Abstracts/full texts, registrations, protocols, SAP and disclosure originals have not been read or accessed. A link does not establish full-text reading or successful access.
- Required materials and conditions: Separate access status for summaries, papers, registrations, protocols, SAP and funding/COI
- Materials to obtain first: Original material and actual reading records for each report
- Further research: Link user-supplied material by type and reading level. Proposed; no new investigation, calculation or trial was performed.
- Conditions for verification: Original materials and the applicable analytical scope for Separate access status for summaries, papers, registrations, protocols, SAP and funding/COI are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
- Why this condition is needed: Production condition for distinguishing Separate access status for summaries, papers, registrations, protocols, SAP and funding/COI and linking required and currently available materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design
- Related sources: S01, S02, S03

## Evidence and sources

### S01

Morriss R et al. 2023 Alpha-Stim-D

[PubMed](https://pubmed.ncbi.nlm.nih.gov/36724796/)

Materials actually read: Summary read; external material unread  
Findings recorded in the summary: Active change −5.9 points, sham −6.5; adjusted active-minus-sham difference +0.6 points (95% CI −1.0 to 2.2), P=0.46. Improvement in both arms is not attributed to added device efficacy. The original interpretation excluding a prespecified 3-point threshold is distinguished from detailed gaps around ITT, 200 observations and original 15.3% missingness. No new difference, interval or response rate is calculated.  
Record level: Outcome wording in the stored summary  
Independent replication: S01 Alpha-Stim-D/ISRCTN11853110 is the direct stored report comparing Alpha-Stim AID with sham at 25 English primary-care sites, with 236 participants allocated 118 per arm. Original 8-week study exposure, 16-week GRID-HDRS-17 change, 200/236 observations and the ITT description are distinguished. The same report, device, arms, period or observation/analysis population is not counted as new independent trials or participants. Report/material records are not unique-trial, participant or independent-replication totals; unique clinical totals remain unrecorded. S02 Barclay 2014 is a sham comparison of Alpha-Stim 100 in 115 participants with depression and anxiety, using a depression scale at 5 weeks. Its model, population and duration differ from AID in major depression at 16 weeks; it is not counted as independent replication of that identical direct question. “Not confirmed” in funding and registration fields does not establish absence or supply an identifier. Report/material records do not establish unique clinical totals, which remain unrecorded. S03 preserves a citation/summary of a 30-participant treatment-resistant-major-depression trial using another device. Its model, duration, comparison, denominators and quantitative values are unverified. It is not direct AID replication at 16 weeks, and its PMID does not newly verify clinical details. Report/material records do not establish unique clinical totals, which remain unrecorded.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Stored file | Stored summary | Summary read | Only stored-summary and bibliographic content was used for production. External material verification/review is not complete. |
| External paper | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Registration material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Protocol | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Statistical analysis plan | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Funding, product-support and COI material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |

### S02

Barclay TH et al. 2014

[PubMed](https://pubmed.ncbi.nlm.nih.gov/24856571/)

Materials actually read: Summary read; external material unread  
Findings recorded in the summary: The original superior-active result, P=0.001 and d=0.78, belongs to the Alpha-Stim 100 question involving 115 participants with depression and anxiety at 5 weeks. It does not certify exact device equivalence to AID or produce a new pooled effect or summed sample.  
Record level: Outcome wording in the stored summary  
Independent replication: S01 Alpha-Stim-D/ISRCTN11853110 is the direct stored report comparing Alpha-Stim AID with sham at 25 English primary-care sites, with 236 participants allocated 118 per arm. Original 8-week study exposure, 16-week GRID-HDRS-17 change, 200/236 observations and the ITT description are distinguished. The same report, device, arms, period or observation/analysis population is not counted as new independent trials or participants. Report/material records are not unique-trial, participant or independent-replication totals; unique clinical totals remain unrecorded. S02 Barclay 2014 is a sham comparison of Alpha-Stim 100 in 115 participants with depression and anxiety, using a depression scale at 5 weeks. Its model, population and duration differ from AID in major depression at 16 weeks; it is not counted as independent replication of that identical direct question. “Not confirmed” in funding and registration fields does not establish absence or supply an identifier. Report/material records do not establish unique clinical totals, which remain unrecorded. S03 preserves a citation/summary of a 30-participant treatment-resistant-major-depression trial using another device. Its model, duration, comparison, denominators and quantitative values are unverified. It is not direct AID replication at 16 weeks, and its PMID does not newly verify clinical details. Report/material records do not establish unique clinical totals, which remain unrecorded.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Stored file | Stored summary | Summary read | Only stored-summary and bibliographic content was used for production. External material verification/review is not complete. |
| External paper | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Registration material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Protocol | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Statistical analysis plan | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Funding, product-support and COI material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |

### S03

Treatment-resistant major-depression trial

[PubMed](https://pubmed.ncbi.nlm.nih.gov/26424428/)

Materials actually read: Summary read; external material unread  
Findings recorded in the summary: This is the original contextual null result. Missing detailed values/CIs are not filled with zero effect, equivalence or a direct AID null estimate.  
Record level: Outcome wording in the stored summary  
Independent replication: S01 Alpha-Stim-D/ISRCTN11853110 is the direct stored report comparing Alpha-Stim AID with sham at 25 English primary-care sites, with 236 participants allocated 118 per arm. Original 8-week study exposure, 16-week GRID-HDRS-17 change, 200/236 observations and the ITT description are distinguished. The same report, device, arms, period or observation/analysis population is not counted as new independent trials or participants. Report/material records are not unique-trial, participant or independent-replication totals; unique clinical totals remain unrecorded. S02 Barclay 2014 is a sham comparison of Alpha-Stim 100 in 115 participants with depression and anxiety, using a depression scale at 5 weeks. Its model, population and duration differ from AID in major depression at 16 weeks; it is not counted as independent replication of that identical direct question. “Not confirmed” in funding and registration fields does not establish absence or supply an identifier. Report/material records do not establish unique clinical totals, which remain unrecorded. S03 preserves a citation/summary of a 30-participant treatment-resistant-major-depression trial using another device. Its model, duration, comparison, denominators and quantitative values are unverified. It is not direct AID replication at 16 weeks, and its PMID does not newly verify clinical details. Report/material records do not establish unique clinical totals, which remain unrecorded.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Stored file | Stored summary | Summary read | Only stored-summary and bibliographic content was used for production. External material verification/review is not complete. |
| External paper | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Registration material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Protocol | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Statistical analysis plan | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Funding, product-support and COI material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Preserved method HTML copies; no current method-content re-review or official tool execution
- M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Preserved method HTML copies; no current method-content re-review or official tool execution
- M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Preserved method HTML copies; no current method-content re-review or official tool execution
- M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Preserved method HTML copies; no current method-content re-review or official tool execution
- M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Preserved method HTML copies; no current method-content re-review or official tool execution

## What the statuses mean

- Met: Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.
- Partly verified: Some information in the stored summary is linked into the table. External comparison/content review is not complete.
- Unverified: The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.
- Review incomplete: Existing content review remains incomplete.
- Not reported: Not reported within the stored material actually read; not extended to the entire primary paper.
- Inaccessible: Means an actual access failure. Access not attempted here is not assigned this state.
- Not applicable: Not used as a substitute for an evidence gap.
- Conflicting data: Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.
- Insufficient evidence for the conditions: Marks a gap in additional material required by the selected conditions; not a new efficacy grade.

## Change history

2026-10-11 · Public page/materials 1.0. A public view and materials were prepared from the existing31 items. No new clinical search, verification-status change or scoring was performed.