{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Vaginal-probe EMG biofeedback × Added benefit at 24 months on top of standard PFMT — Evidence checklist",
  "language": "en",
  "translation_date": "2026-10-11",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "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."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "How are the selected added-device effect and parent verdict distinguished?",
      "needed": "Separate the existing subclaim, grade D and note from parent score and axes",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Separate the existing subclaim, grade D and note from parent 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 existing subclaim, grade D and note from parent 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": "Update the existing question and parent context separately. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Which population of women was included in OPAL?",
      "needed": "Incontinence type, contraction ability, eligibility/exclusions and baseline conditions",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Incontinence type, contraction ability, eligibility/exclusions and baseline conditions 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 Incontinence type, contraction ability, eligibility/exclusions and baseline conditions 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": "Link inclusion and exclusion boundaries to the results. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "What are the device and PFMT common to both groups?",
      "needed": "Home vaginal-probe EMG, supervised PFMT and actual comparator composition",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Home vaginal-probe EMG, supervised PFMT and actual comparator composition 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 Home vaginal-probe EMG, supervised PFMT and actual comparator composition 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": "Separate the shared underlying intervention from the added device component. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Is the comparison against no treatment, or about added device benefit?",
      "needed": "Effect of interest, active comparison and attribution of common treatment",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Effect of interest, active comparison and attribution of common treatment 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, active comparison and attribution of common treatment 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 test adaptations are Chamgap design; M08 §8.2.2, M15 §15.3.1; 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": "Keep the PFMT-itself and added-device-effect questions separate. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "What is known about study exposure, duration and adherence?",
      "needed": "Intervention frequency/duration, actual device use, common treatment and rescue treatment",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Intervention frequency/duration, actual device use, common treatment and rescue treatment 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 Intervention frequency/duration, actual device use, common treatment and rescue treatment 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; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations 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": "Record actual exposure separately from observation duration. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "How were randomization and baseline balance recorded?",
      "needed": "Randomization method, concealment and group-specific baseline characteristics",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Randomization method, concealment and group-specific baseline characteristics 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 Randomization method, concealment and group-specific baseline characteristics 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": "Distinguish the RCT label from actual allocation information. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Which measurement is affected by blinding limitations?",
      "needed": "Participant, therapist and assessor blinding and measurement procedures",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Participant, therapist and assessor blinding 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, therapist and assessor blinding 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": "Link subjective-symptom measurement conditions to the known limitations. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "What does the 24-month ICIQ-UI SF value measure?",
      "needed": "Scale, units, final value/change, time point and primary-outcome definition",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Scale, units, final value/change, time point and primary-outcome definition 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, units, final value/change, time point and primary-outcome definition 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; outcome adaptation to each question is internally designed; M08 Table 8.2.a, M03 §3.2.4; 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": "Attribute time point, scale, final values and change values separately. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "Are group means distinguished from the adjusted mean difference?",
      "needed": "Group correspondence, original means, adjusted estimator and model",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Group correspondence, original means, adjusted estimator and model 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 Group correspondence, original means, adjusted estimator and model 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": "Keep original means and the adjusted comparative estimator as different values. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "What are the observed interval, P value and clinical importance?",
      "needed": "Original effect, CI, P value and range of important differences",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Original effect, CI, P value and range of important differences 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 Original effect, CI, P value and range of important differences 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; Chamgap adaptation; 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": "Record the observed interval and original importance interpretation within their source scope. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "What prespecified criterion is the 2.5-point threshold?",
      "needed": "Important between-group difference for sample-size calculation, rationale and timing",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Important between-group difference for sample-size calculation, rationale and timing 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 between-group difference for sample-size calculation, rationale and timing 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": "Link the original prespecified criterion separately from later analytical criteria. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Is the 1.9-point MID from another independent trial?",
      "needed": "Data identity, timing, model and precision of the later anchor analysis",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Data identity, timing, model and precision of the later anchor analysis 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 Data identity, timing, model and precision of the later anchor analysis 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 distinction between studies and reports; cohort/outcome linking is Chamgap adaptation; M15 §15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M04 §4.6.3; 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 the later analysis of the same OPAL data to the original trial. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "How far is the original interpretation of excluding both thresholds preserved?",
      "needed": "Original observed interval, 1.9/2.5 criteria and interpretation history",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Original observed interval, 1.9/2.5 criteria and interpretation history 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 Original observed interval, 1.9/2.5 criteria and interpretation history 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; Chamgap adaptation; M04 §4.5, §4.6.3; limitations of the current material conversion follow the review scope and 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": "Distinguish the original interpretation from decisions based on new material. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "How do allocation and 24-month analysis denominators differ?",
      "needed": "Allocation, questionnaire observations and outcome-specific analytical denominators",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Allocation, questionnaire observations and outcome-specific analytical 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 Allocation, questionnaire observations and outcome-specific analytical denominators 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 original allocation, observation and analysis denominators separately. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "What are the language-specific stored descriptions of return and attrition?",
      "needed": "Questionnaire return, missingness/attrition definitions, group-specific reasons and handling",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Questionnaire return, missingness/attrition definitions, group-specific reasons and handling 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 Questionnaire return, missingness/attrition definitions, group-specific reasons and handling 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; M04 §4.5, §4.6.3; limitations of the current material conversion follow the review scope and Chamgap design; M08 §8.2.2, M15 §15.3.1; 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": "Distinguish historical wording by language from actual observation/analysis definitions. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Does the actual analysis estimate assignment effects or adherence effects?",
      "needed": "ITT/PP, effect of interest, adjustment, missingness and sensitivity",
      "role": "Required",
      "role_reason": "Production condition for distinguishing ITT/PP, effect of interest, adjustment, missingness and sensitivity 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 ITT/PP, effect of interest, adjustment, missingness and sensitivity 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": "Link the effect answered by the analysis to the selected question. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Were the registry, protocol and SAP actually compared?",
      "needed": "Original registration identifier, plans, change history and primary outcome",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Original registration identifier, plans, change history and primary outcome 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 Original registration identifier, plans, change history and primary outcome 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": "Distinguish changes if material comparing prespecified plans with actual reporting is provided. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "What were the public funding and sponsor institution?",
      "needed": "Separate funding, project, sponsor institution and roles",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Separate funding, project, sponsor institution 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 Separate funding, project, sponsor institution 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": "Link funding, institutions and actual roles separately. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Are the four manufacturer-related items actually absent?",
      "needed": "Cash funding, free equipment, employed authors and outsourced analysis",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Cash funding, free equipment, employed authors and outsourced analysis 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 Cash funding, free equipment, employed authors and outsourced analysis 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": "Update each unverified item separately. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Are other COI, patents and writing/publication support known?",
      "needed": "Individual disclosures, patents, manuscript/publication costs and roles",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Individual disclosures, patents, manuscript/publication costs 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 Individual disclosures, patents, manuscript/publication costs 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": "Link disclosed roles to their funding scope. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Did Burgio 2002 test the same device added to PFMT?",
      "needed": "Differences in population, three multicomponent behavioral programs, comparison and outcome",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Differences in population, three multicomponent behavioral programs, comparison and outcome 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 Differences in population, three multicomponent behavioral programs, comparison and outcome 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 and M15 §15.3.1: in-house application; M03 §3.2.1: detailed population conditions are in-house; M03 §3.2.2–3.2.3: reverse-direction labeling and test adaptation are 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": "Link this as context with different populations and comparison definitions. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "What are the values from Burgio's three arms?",
      "needed": "Episode reduction, group correspondence, original percentages, P value and denominators",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Episode reduction, group correspondence, original percentages, P value 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 Episode reduction, group correspondence, original percentages, P value and denominators 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; outcome adaptations by question are our own design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by study design are our own design; M08 §8.2.2, M15 §15.3.1; our own application; 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": "Distinguish episode reduction from ICIQ, quality of life and cure rates. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "What history do Burgio's registration and funding descriptions record?",
      "needed": "Registration wording, actual identifier and funding/COI",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Registration wording, actual identifier 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 Registration wording, actual identifier and funding/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; M04 §4.5, §4.6.3; limitations of the current material conversion follow the review scope and 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 historical wording separately from actual identity material provided. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "What are Cochrane's overall comparison and outcome-specific denominators?",
      "needed": "Whole review, analytical subsets and trial/participant overlap",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Whole review, analytical subsets and trial/participant overlap 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 Whole review, analytical subsets and trial/participant overlap are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linking is Chamgap adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M04 §4.6.1–4.6.2, M15 §15.3.1; 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 the review to original trials and outcome analyses. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Is the review quality-of-life value the same as the added ICIQ effect?",
      "needed": "Quality-of-life outcome, standardized estimator and subset denominator",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Quality-of-life outcome, standardized estimator and subset denominator 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 Quality-of-life outcome, standardized estimator and subset denominator 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 Chamgap design; M15 §15.3.1–15.3.3; Chamgap adaptation; M04 §4.6.1–4.6.2, M15 §15.3.1; 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": "Keep quality of life separate from 24-month ICIQ scores. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "How are review cure/improvement and its lower CI bound preserved?",
      "needed": "Cure/improvement definitions, OR, interval and subset denominator",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Cure/improvement definitions, OR, interval and subset denominator 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 Cure/improvement definitions, OR, interval and subset denominator 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; Chamgap adaptation; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is 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": "Preserve original interval-boundary wording and separate outcome status. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Do the review funding and registration fields represent actual disclosures?",
      "needed": "Review funding/COI, protocol and registration identity",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Review funding/COI, protocol and registration identity 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 Review funding/COI, protocol and registration identity 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": "Distinguish material type from funding and identity fields. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Are independent replication and later analysis of the same data distinguished?",
      "needed": "Report-to-trial-family-to-result linkage and direct/context relationships",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Report-to-trial-family-to-result linkage and direct/context relationships 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 Report-to-trial-family-to-result linkage and direct/context relationships 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 distinction between studies and reports; cohort/outcome linking is Chamgap adaptation; M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap adaptation; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is 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": "Separate report-item counts from unique clinical-trial/participant counts. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N29",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "What is the reporting scope of non-serious adverse events?",
      "needed": "Person/event counts, group-specific denominators, duration and collection",
      "role": "Supplementary",
      "role_reason": "Production condition for distinguishing Person/event counts, group-specific denominators, duration and collection and linking required and currently available materials for the selected question.",
      "application_exception": "Supplement safety-information gaps for the selected subclaim. Incontinence-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 Person/event counts, group-specific denominators, duration and collection 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 §19.1.2–19.2.4; detailed distinctions are Chamgap design; M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.1.2–19.2.4, M04 §4.6.3; 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": "Separate efficacy-analysis denominators from harm-observation denominators. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N30",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "How far do probe-related event and seriousness descriptions extend?",
      "needed": "Discomfort, bleeding, serious events, timing and relatedness assessment",
      "role": "Supplementary",
      "role_reason": "Production condition for distinguishing Discomfort, bleeding, serious events, timing and relatedness assessment and linking required and currently available materials for the selected question.",
      "application_exception": "Supplement safety-information gaps for the selected subclaim. Incontinence-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 Discomfort, bleeding, serious events, timing and relatedness assessment 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": "Record relatedness, seriousness and reporting-scope limitations separately. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N31",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Is the result extended to excluded groups, learning support, PFMT itself or long-term harm?",
      "needed": "Selected scope and direct material for separate populations, uses and durations",
      "role": "Supplementary",
      "role_reason": "Production condition for distinguishing Selected scope and direct material for separate populations, uses and durations and linking required and currently available materials for the selected question.",
      "application_exception": "Supplement safety-information gaps for the selected subclaim. Incontinence-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 Selected scope and direct material for separate populations, uses and durations 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 current added-device effect from extended questions. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "What is the scope of dates, language-specific wording, original axes and correction history?",
      "needed": "Original verdict date, Korean/English manuscripts, cross-checking and correction/retraction verification level",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Original verdict date, Korean/English manuscripts, cross-checking and correction/retraction verification level 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 Original verdict date, Korean/English manuscripts, cross-checking and correction/retraction verification level 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 historical values from production/change events. This is a recorded proposal; no new search, calculation or experiment was performed."
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "What was actually read in the summary and external originals?",
      "needed": "Access status of the stored summary, papers, registry, protocol, SAP and disclosures",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Access status of the stored summary, papers, registry, protocol, SAP and disclosures 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 Access status of the stored summary, papers, registry, protocol, SAP and disclosures 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 existence, acquisition and actual-reading levels separately for each material. This is a recorded proposal; no new search, calculation or experiment was performed."
    }
  ]
}