{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Didgeridoo training × replacement for standard OSA therapy",
  "language": "en",
  "translation_date": "2026-10-16",
  "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": "A state used when required evidence is confirmed after user review. This production does not declare that review complete.",
    "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": "User review pending.",
    "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": "What is the original grade for the selected treatment-replacement question?",
      "needed": "Selected wording, note and grade versus parent efficacy signals",
      "role": "Required",
      "role_reason": "This condition connects Selected wording, note and grade versus parent efficacy signals with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Selected wording, note and grade versus parent efficacy signals must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Subclaim score, status and axes are absent from the original. Direct evidence for replacing standard therapy is unlinked. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "The actual comparator was a wait list",
      "needed": "Agreement for a direct comparison with standard therapy",
      "role": "Required",
      "role_reason": "This condition connects Agreement for a direct comparison with standard therapy with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Agreement for a direct comparison with standard therapy must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Direct-comparison design, interventions, denominators and original results for standard therapy are unlinked. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Standard-therapy comparison and noninferiority",
      "needed": "Direct comparison, prior hypotheses and noninferiority/equivalence agreement",
      "role": "Required",
      "role_reason": "This condition connects Direct comparison, prior hypotheses and noninferiority/equivalence agreement with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Direct comparison, prior hypotheses and noninferiority/equivalence agreement must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Prior comparative hypotheses, noninferiority margins, testing plans and direct estimands are unlinked. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Narrow eligibility in the existing trial",
      "needed": "Direct-comparison population, diagnosis, severity and denominators",
      "role": "Required",
      "role_reason": "This condition connects Direct-comparison population, diagnosis, severity and denominators with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Direct-comparison population, diagnosis, severity and denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Eligibility, baseline therapy, severity, risk and denominators corresponding to a replacement comparison are unlinked. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Structured program and brand generalization",
      "needed": "Existing program, actual exposure and comparator intervention",
      "role": "Required",
      "role_reason": "This condition connects Existing program, actual exposure and comparator intervention with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Existing program, actual exposure and comparator intervention must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Program components and exposure/adherence in direct comparisons with standard therapy are unlinked. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Mean exposure and absence of a replacement regimen",
      "needed": "Study means, distributions and direct-comparison exposure",
      "role": "Required",
      "role_reason": "This condition connects Study means, distributions and direct-comparison exposure with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Study means, distributions and direct-comparison exposure must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Individual adherence, exposure distributions and actual use conditions in direct comparisons are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "The ESS signal is a wait-list result",
      "needed": "Sleepiness estimand, directness and units",
      "role": "Required",
      "role_reason": "This condition connects Sleepiness estimand, directness and units with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Sleepiness estimand, directness and units must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: ESS effects versus standard therapy, denominators, CIs and prior agreements are unlinked. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "The AHI signal and the boundary of replacement",
      "needed": "Objective measure, standard-therapy comparison and clinical outcomes",
      "role": "Required",
      "role_reason": "This condition connects Objective measure, standard-therapy comparison and clinical outcomes with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Objective measure, standard-therapy comparison and clinical outcomes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: AHI from direct treatment comparisons, normalization/response criteria and long-term clinical endpoints are unlinked. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "Nonsignificant PSQI and the full results",
      "needed": "Discordant efficacy endpoints and denominators",
      "role": "Required",
      "role_reason": "This condition connects Discordant efficacy endpoints and denominators with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Discordant efficacy endpoints and denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Overall sleep/symptom results, endpoint hierarchy and denominators in direct comparisons are unlinked. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Attribution of subjective bed-partner assessment",
      "needed": "Respondents, scale, denominators and separation from replacement outcomes",
      "role": "Required",
      "role_reason": "This condition connects Respondents, scale, denominators and separation from replacement outcomes with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Respondents, scale, denominators and separation from replacement outcomes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Respondent denominators, scale, exact CI/P and the replacement-comparison agreement are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "A prior estimand for the replacement question",
      "needed": "Clinical question, endpoints, comparator, units and analysis population",
      "role": "Required",
      "role_reason": "This condition connects Clinical question, endpoints, comparator, units and analysis population with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Clinical question, endpoints, comparator, units and analysis population must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Definition of replacement, comparative endpoints, analysis populations, estimands and observation windows are unlinked. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Concurrent therapy, rescue therapy and exposure",
      "needed": "Records of existing therapy, additional care and rescue exposure",
      "role": "Required",
      "role_reason": "This condition connects Records of existing therapy, additional care and rescue exposure with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Records of existing therapy, additional care and rescue exposure must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Baseline/concurrent therapies, changes, rescue exposure and direct-comparison conditions are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Allocation, waiting and expectations",
      "needed": "Randomization, concealment, contact and masking",
      "role": "Required",
      "role_reason": "This condition connects Randomization, concealment, contact and masking with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Randomization, concealment, contact and masking must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Allocation concealment, contact/expectation differences, assessor/analyst masking and direct-comparison conditions are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "All 25 completing versus analysis/comparison denominators",
      "needed": "Completion, endpoint analysis, missingness and ITT/PP",
      "role": "Required",
      "role_reason": "This condition connects Completion, endpoint analysis, missingness and ITT/PP with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Completion, endpoint analysis, missingness and ITT/PP must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Allocation by arm, endpoint analyses, ITT/PP, missingness and separate-comparison denominator/size agreements are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Retrospective registration and no prior replacement agreement",
      "needed": "Registration dates, hypotheses, changes and prior hierarchy",
      "role": "Required",
      "role_reason": "This condition connects Registration dates, hypotheses, changes and prior hierarchy with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Registration dates, hypotheses, changes and prior hierarchy must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Prerecruitment replacement hypotheses, comparison plans, exact registration/recruitment dates and change history remain unread. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "ESS main outcome and hierarchy among multiple results",
      "needed": "Preserved main outcome, protocol, SAP and multiplicity",
      "role": "Required",
      "role_reason": "This condition connects Preserved main outcome, protocol, SAP and multiplicity with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Preserved main outcome, protocol, SAP and multiplicity must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Prerecruitment plans, analysis models, multiplicity and replacement-related outcome agreements are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Overlap of paper, registration and two sheets",
      "needed": "Reports, registration and relationships within the same population/trial",
      "role": "Required",
      "role_reason": "This condition connects Reports, registration and relationships within the same population/trial with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Reports, registration and relationships within the same population/trial must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Detailed analysis correspondence between external paper and registration remains unread. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Independent material for replacing standard therapy",
      "needed": "A separate trial under the same comparison agreement",
      "role": "Required",
      "role_reason": "This condition connects A separate trial under the same comparison agreement with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for A separate trial under the same comparison agreement must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Direct comparison for the replacement question, its separate replication and family independence are unlinked. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Four months versus long-term complications and persistence",
      "needed": "Symptoms, sleep tests and clinical outcomes over time",
      "role": "Required",
      "role_reason": "This condition connects Symptoms, sleep tests and clinical outcomes over time with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Symptoms, sleep tests and clinical outcomes over time must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Long-term direct comparisons, clinical events and persistence after intervention cessation are unlinked. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Generalizing replacement to other populations",
      "needed": "Direct comparisons in other BMIs, severities, ages and conditions",
      "role": "Required",
      "role_reason": "This condition connects Direct comparisons in other BMIs, severities, ages and conditions with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Direct comparisons in other BMIs, severities, ages and conditions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Population-specific direct comparisons, denominators and clinical/safety outcomes are unlinked. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Support, developers and independence gaps",
      "needed": "Funding, equipment support, developer roles and COI",
      "role": "Required",
      "role_reason": "This condition connects Funding, equipment support, developer roles and COI with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Funding, equipment support, developer roles and COI must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Original material on funder roles, instrument/product support, developer-instructor roles, employee authors and COI is unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Existing safety wording and stopping treatment",
      "needed": "Actual event collection, exposure, comparisons, denominators and follow-up",
      "role": "Supplementary",
      "role_reason": "This condition connects Actual event collection, exposure, comparisons, denominators and follow-up with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Actual event collection, exposure, comparisons, denominators and follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Rare/long-term harms, direct replacement comparisons, stopping risks and arm-specific collection/denominators are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Distinguishing unknown from null effects or cure",
      "needed": "Material separating untested replacement, signals and unknowns",
      "role": "Required",
      "role_reason": "This condition connects Material separating untested replacement, signals and unknowns with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Material separating untested replacement, signals and unknowns must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Comparative effects, uncertainty and clinical judgment material for the direct replacement question are unlinked. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Are parent values, subclaim grade and the evidence date separated?",
      "needed": "Parent/subclaim original values and historical dates",
      "role": "Required",
      "role_reason": "This condition connects Parent versus subclaim original values and historical dates with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Parent/subclaim original values and historical dates must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Subclaim score, status and axes are absent from the original. New corrections and external original-text comparisons were not performed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Are historical checks the current reading?",
      "needed": "Historical review statements, summary use and external access",
      "role": "Required",
      "role_reason": "This condition connects Historical review wording, summary use and external access with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Historical review statements, summary use and external access must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Historical-check details, current external-original acquisition/reading and content review remain incomplete. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Which materials would trigger an update?",
      "needed": "Linking summary reading, unread originals and needed material",
      "role": "Required",
      "role_reason": "This condition connects Links between summary reading, unread external material and further material with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.",
      "application_exception": "Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.",
      "criterion": "Material for Linking summary reading, unread originals and needed material must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: External-original acquisition, reading, URL verification and content review are needed. Complete pre-change originals, material/condition versions, separate application and change history must be retained. This records needed materials; no new research was executed."
    }
  ]
}