{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2952-s0", "verdict_number": "2952", "title": "Alpha-Stim AID × Major depression at 16 weeks — Evidence checklist", "view_version": "1.0", "view_created_date": "2026-10-11", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "Major-depression population in English primary care; detailed selection conditions unverified", "intervention": "Alpha-Stim AID; only the original 8-week study-exposure wording is preserved", "dose": null, "comparator": "Sham; detailed configuration and common treatment unverified", "endpoint": "16-week GRID-HDRS-17 change; adjusted active-minus-sham difference", "duration": "Distinguish the 8-week study intervention from the 16-week assessment", "excluded_extensions": [ "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" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which original question and verdict are preserved?", "needed": "Separate the selected subclaim from the parent verdict, score and axes", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "If the text changes, update the selected question link and parent context separately. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The subclaim has no score, status or axes keys; parent values do not fill them.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Correction records for the selected subclaim or parent text" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Which major-depression population was actually studied?", "needed": "Diagnosis, age, severity, selection/exclusion and recruitment setting", "role": "Required", "role_reason": "Production condition for distinguishing Diagnosis, age, severity, selection/exclusion and recruitment setting and linking required and currently available materials for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "M03 §3.2.1; detailed population conditions are Chamgap's own design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "If direct results for particular populations are provided, distinguish their applicable scope. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The population cannot be confirmed as equivalent to depression with anxiety or treatment-resistant depression.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Alpha-Stim-D recruitment criteria and baseline-characteristics table" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Which device model was tested, and is it equivalent to other CES devices?", "needed": "Identity of the AID model, waveform, electrodes and device configuration", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Link different device reports by model and indication. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Exact equivalence or compatibility between AID and 100, and the S03 model identity, are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-device specifications and product identity for each report" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "How do study exposure and the assessment time differ?", "needed": "Study-intervention duration, exposure records and endpoint time", "role": "Required", "role_reason": "Production condition for distinguishing Study-intervention duration, exposure records and endpoint time and linking required and currently available materials for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Track actual study exposure and observation times separately. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Actual cumulative exposure, use after discontinuation, adherence by arm and intervention after 8 weeks are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exposure, adherence and discontinuation records and the 16-week assessment schedule" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What actually differed between active and sham devices?", "needed": "Active/sham configuration, sensation, concomitant treatment and comparison direction", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "If comparison details are obtained, distinguish added device contributions from accompanying changes. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The pivotal report describes a sham-controlled RCT. The adjusted difference is explicitly active minus sham.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Exact sham output and sensation, common treatment and changes by arm are unverified in this summary.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Active/sham specifications and concomitant-treatment table" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "How are randomization and concealment recorded?", "needed": "Allocation method, concealment and baseline balance", "role": "Required", "role_reason": "Production condition for distinguishing Allocation method, concealment and baseline balance and linking required and currently available materials for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "If methods material is provided, link allocation information relevant to the selected outcome. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The preserved description states that 236 participants were randomized, 118 per arm, through an independent web system.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Details of sequence generation, operational concealment and baseline balance by arm have not been read.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original allocation-method description and baseline-characteristics table" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Who was masked, and is masking success known?", "needed": "Participant, assessor and analyst masking and measurement procedures", "role": "Required", "role_reason": "Production condition for distinguishing Participant, assessor and analyst masking and measurement procedures and linking required and currently available materials for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "M08 Table 8.2.a, M03 §3.2.4; internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Record unresolved masking information separately from actual measurement limitations. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original description of participant, outcome-assessor and data-analyst masking is preserved.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Device operators’ roles, evaluation of masking success and measurement differences by arm are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Masking and assessment-operation records" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What outcome does 16-week GRID-HDRS-17 represent?", "needed": "Scale definition, units, direction, assessment method and time", "role": "Required", "role_reason": "Production condition for distinguishing Scale definition, units, direction, assessment method and time and linking required and currently available materials for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Attribute definitions and analyses to their respective endpoints. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Detailed scale-assessment procedures, baseline values and variance by arm are unverified in this summary.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Scale-measurement methods and the 16-week results table" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Are changes within each arm distinguished from between-arm differences?", "needed": "Separate arm-specific changes from the comparative estimate", "role": "Required", "role_reason": "Production condition for distinguishing Separate arm-specific changes from the comparative estimate and linking required and currently available materials for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Preserve within-arm improvement separately from the active-minus-sham effect. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Confidence intervals, variance, denominators and the change model for each arm are unverified. No new between-arm difference is calculated from these values.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific change table and comparative model" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "What are the adjusted between-arm estimate, CI and P value?", "needed": "Comparison direction, adjustment model, denominator and original estimate", "role": "Required", "role_reason": "Production condition for distinguishing Comparison direction, adjustment model, denominator and original estimate and linking required and currently available materials for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Link the original estimate and interval to their analysis. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original adjusted active-minus-sham difference of +0.6 points, 95% CI −1.0 to 2.2, P=0.46 is preserved.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Adjustment variables, model, variance and arm-specific analysis denominators are unverified. No new effect estimate or CI is calculated.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adjusted-analysis table and SAP" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "How are the prespecified 3-point threshold and original interpretation preserved?", "needed": "Important-difference criterion, timing of its specification and interpretation scope", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Distinguish the prespecified importance criterion from its relationship to newly supplied analyses. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Threshold rationale, registration, protocol and SAP" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Are allocation, 16-week observation and missingness distinguished?", "needed": "Allocation and observation denominators, missingness by arm and reasons", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Link allocation and observation denominators to each outcome. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original 236 randomized, 118 allocated per arm, 200/236 observed at 16 weeks and 15.3% missingness are preserved.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Observed and missing counts, reasons and timing by arm are unverified. No new missing count or percentage is calculated.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Flow diagram and arm-specific observation/missingness tables" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Does the ITT description adequately explain the actual analysis?", "needed": "Effect of interest, missing-data handling, model and sensitivity analyses", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Distinguish an analysis of observed participants from estimation of the effect of assignment. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original text describes ITT analysis. The 200/236 observations at 16 weeks are not assumed to equal the ITT-analysis denominator.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Imputation, model assumptions about missingness, the actual analysis denominator and sensitivity results are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "ITT-analysis description, SAP and sensitivity results" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Were endpoints, analyses and times compared with the plans?", "needed": "Registration, protocol and SAP alongside reported outcomes", "role": "Required", "role_reason": "Production condition for distinguishing Registration, protocol and SAP alongside reported outcomes and linking required and currently available materials for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "If planning material is provided, record changes to endpoints, analyses and times separately. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original registration field contains ISRCTN11853110. The 16-week GRID outcome and prespecified 3-point wording are linked to the summary.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Registration, protocol, SAP and amendment history have not been read or accessed in this production. An identifier does not establish completed comparison with plans.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration history, protocol, and SAP" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Are concomitant treatment, adherence and treatment changes known by arm?", "needed": "Arm-specific antidepressant treatment, counselling, adherence and rescue-treatment records", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Link material that distinguishes common treatment from added device contributions. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The active/sham comparison and 8-week study-exposure wording are preserved.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Medication, counselling, other treatment, actual adherence, discontinuation, changes and their analytical handling by arm are unverified in this summary.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Concomitant-treatment, adherence, deviation and treatment-change tables" }, { "item_id": "N16", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "How are safety review and early stopping recorded?", "needed": "Original description of review structure, stopping boundaries and completed follow-up", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Record advance plans separately from actual stopping. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original description states that a safety-review structure existed, but 16-week assessment was completed without early stopping after a boundary was reached.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Stopping-boundary values, committee decisions and interim-analysis documents have not been read. Absence of early stopping does not establish efficacy or safety.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Review plans and interim/final decision records" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "What was the actual scope of NIHR support?", "needed": "Funding providers, supported items and roles", "role": "Required", "role_reason": "Production condition for distinguishing Funding providers, supported items and roles and linking required and currently available materials for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Distinguish support sources, roles and product support. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original wording on NIHR ARC East Midlands support and mixed NIHR/EPI support is preserved.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "NIHR-funded items, amounts, contracts, disbursement and detailed roles are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Funding disclosures and support contracts" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Which costs and devices did EPI provide?", "needed": "Manufacturer cash/cost support, product provision and scope of influence", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Support alone does not justify excluding the result or certifying independence. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original record states that EPI provided excess treatment and health-economic evaluation costs and active/sham devices.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Amounts by item, conditions of provision and the full extent of additional support are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original product/cost-support disclosures" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Which roles does the no-involvement declaration cover?", "needed": "Role disclosures for design, collection, analysis, interpretation and writing", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Record declared non-involvement separately from the actual level of verification. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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”.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Protocol role disclosures and company-identity material" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are author employment, patents and analysis/publication support known?", "needed": "Author affiliations, COI, external analysis and manuscript/publication support", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Link supplied disclosures item by item. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Only the preserved wording on manufacturer support and the no-involvement declaration is available.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Detailed disclosures of employee authors, patents, individual COI, outsourced analysis and publication/writing costs are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Author/COI and analysis/publication-support material" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Does the 115-participant trial address the same AID question at 16 weeks?", "needed": "Agreements and differences in device, population, duration, scale and comparison", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Record comparison specifications separately by device, population and assessment time. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Barclay paper, device specifications and population/analysis tables" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Were registration and funding for the Barclay trial verified?", "needed": "Actual registration identifier, support and COI", "role": "Required", "role_reason": "Production condition for distinguishing Actual registration identifier, support and COI and linking required and currently available materials for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "If an actual identifier or disclosure is provided, distinguish it from the original wording. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Both S02 funding and registration fields originally say “Not confirmed”. That wording is preserved.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Registration and funding/product/author disclosures are unverified. “Not confirmed” is neither a registration identifier nor evidence of no support or no registration.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original registration, funding and COI material for that trial" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "What context does the 30-participant treatment-resistant-depression trial provide?", "needed": "Population, device, duration, endpoint, denominator and quantitative results", "role": "Required", "role_reason": "Production condition for distinguishing Population, device, duration, endpoint, denominator and quantitative results and linking required and currently available materials for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Preserve the conditions of reports involving other populations or devices. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S03 paper and population, device and analysis tables" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are registration and support for the 30-participant trial known?", "needed": "Registration identifier, support, product provision and COI", "role": "Required", "role_reason": "Production condition for distinguishing Registration identifier, support, product provision and COI and linking required and currently available materials for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Record the actual status and identity of material obtained. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "S03 funding and registration originally say “Not confirmed”.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Original registration, funding, products and author relationships are unverified. Unverified information is not converted to absence.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S03 registration and funding/COI material" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are conflicting findings and the original replication limits preserved?", "needed": "Family-specific conditions, positive/null findings and original replication limits", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Distinguish direct replication of the same question within the scope of newly supplied material. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-condition tables and related-report links" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "How are duplicate reports, trials and participants handled?", "needed": "Links from citations to trial families, outcomes and denominators", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Link citation, trial, population and time relationships separately. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-specific registrations and included/related-report tables" }, { "item_id": "N27", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "What are the original adverse-event frequencies and their scope?", "needed": "Event definitions, people/events by arm, period and collection method", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Record efficacy and harm denominators, periods and observations separately. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original text records adverse events in 9/118 (8%) active and 8/118 (7%) sham participants. Only these original frequencies are preserved.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adverse-event tables by arm and collection plan" }, { "item_id": "N28", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "What is recorded about serious events and causal attribution?", "needed": "Event identity, timing, concurrent exposure and attribution basis", "role": "Supplementary", "role_reason": "Production condition for distinguishing Event identity, timing, concurrent exposure and attribution basis and linking required and currently available materials for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Distinguish event reporting from the material actually supporting relatedness assessment. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original description records 1 hospitalization for suicidal ideation in the sham arm, judged unrelated to the device.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Serious-event details and attribution basis" }, { "item_id": "N29", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Are 16-week findings extended to other durations, indications or overall safety?", "needed": "Direct evidence for long-term outcomes, vulnerable groups and other devices/indications", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Separate the selected question from extended questions. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Sustained effects after 16 weeks, long-term/rare harms and direct results for other indications are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term follow-up and material on other devices/populations" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "What history do dates, Korean/English text, empty corrections and cross-checking represent?", "needed": "Historical verdict date, language-specific wording, correction history and actual current actions", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Distinguish original records, change events and production versions. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "It does not indicate current external-source comparison, correction/retraction checking, language-original comparison or completed content review.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "New correction records and user feedback" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Which materials were actually read, and which links were only preserved?", "needed": "Separate access status for summaries, papers, registrations, protocols, SAP and funding/COI", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Link user-supplied material by type and reading level. Proposed; no new investigation, calculation or trial was performed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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”.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original material and actual reading records for each report" } ], "reports": [ { "report_id": "S01", "title": "Morriss R et al. 2023 Alpha-Stim-D", "url": "https://pubmed.ncbi.nlm.nih.gov/36724796/", "report_type": "Multicenter double-blind sham-controlled RCT", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2952-ALPHA-STIM-D", "independent_replication": null, "observed_result": "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.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/36724796/" } ] }, { "report_id": "S02", "title": "Barclay TH et al. 2014", "url": "https://pubmed.ncbi.nlm.nih.gov/24856571/", "report_type": "Randomized sham-controlled trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2952-BARCLAY-2014", "independent_replication": null, "observed_result": "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.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/24856571/" } ] }, { "report_id": "S03", "title": "Treatment-resistant major-depression trial", "url": "https://pubmed.ncbi.nlm.nih.gov/26424428/", "report_type": "Randomized controlled trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2952-TRD-CONTEXT", "independent_replication": null, "observed_result": "This is the original contextual null result. Missing detailed values/CIs are not filled with zero effect, equivalence or a direct AID null estimate.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/26424428/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" } ], "status_dictionary": { "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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "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." }, "history": [ { "date": "2026-10-11", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "A public view and materials were prepared from the existing31 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-11" }