{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Didgeridoo training × daytime sleepiness in moderate OSA",
  "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": "Which daytime-sleepiness claim is examined?",
      "needed": "Selected sleepiness claim, note/grade and parent verdict",
      "role": "Required",
      "role_reason": "This condition connects Selected sleepiness claim, note/grade and parent verdict with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 sleepiness claim, note/grade and parent verdict 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: Separate subclaim score, status and axes are absent from the original. The selected claim and parent verdict must be distinguished. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Which adults with moderate OSA were studied?",
      "needed": "Eligibility, baseline characteristics, diagnosis and arm denominators",
      "role": "Required",
      "role_reason": "This condition connects Eligibility, baseline characteristics, diagnosis and arm denominators with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 Eligibility, baseline characteristics, diagnosis and arm 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: Exact age, sex, baseline ESS, diagnostic procedures and arm allocation denominators are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Which program was studied?",
      "needed": "Lessons, home practice, developer and intervention specification",
      "role": "Required",
      "role_reason": "This condition connects Lessons, home practice, developer and intervention specification with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 Lessons, home practice, developer and intervention specification 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: Lesson components, contact, individual actual practice and generalizable components are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Does average practice describe an individual procedure?",
      "needed": "Planned exposure, mean actual exposure, distribution and adherence",
      "role": "Required",
      "role_reason": "This condition connects Planned exposure, mean actual exposure, distribution and adherence with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 Planned exposure, mean actual exposure, distribution and adherence 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: Planned exposure, individual distributions, discontinuation, adherence assessment and ESS by exposure are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "What does the wait-list comparison establish?",
      "needed": "Control care, contact, expectations and concurrent treatment",
      "role": "Required",
      "role_reason": "This condition connects Control care, contact, expectations and concurrent treatment with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 Control care, contact, expectations and concurrent treatment 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 wait-list care, contact, expectation differences and concurrent treatment are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Are randomization and concealment detailed?",
      "needed": "Allocation sequence, concealment and recruitment processes",
      "role": "Required",
      "role_reason": "This condition connects Allocation sequence, concealment and recruitment processes with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 Allocation sequence, concealment and recruitment processes 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: Sequence generation, concealment, responsible staff and recruitment/allocation processes are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Is unblinded symptom assessment distinguished?",
      "needed": "Participant, assessor/analyst masking and expectation differences",
      "role": "Required",
      "role_reason": "This condition connects Participant, assessor/analyst masking and expectation differences with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 Participant, assessor/analyst masking and expectation differences 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: Assessor/analyst masking, contact/expectation differences and their control are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "What did ESS assess and when?",
      "needed": "Scale, assessment window, method and units",
      "role": "Required",
      "role_reason": "This condition connects Scale, assessment window, method and units with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 Scale, assessment window, method 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: Scale administration, recall period, assessment timing, standardization and baseline distributions are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "What is the original ESS difference, CI and P value?",
      "needed": "Comparative estimate, units, denominators and model",
      "role": "Required",
      "role_reason": "This condition connects Comparative estimate, units, denominators and model with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 Comparative estimate, units, denominators and model 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 arm values, exact analysis denominators, model, baseline adjustment and outcome-hierarchy details are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Are ESS importance and individual distributions verified?",
      "needed": "Relevance thresholds, individual changes and uncertainty",
      "role": "Required",
      "role_reason": "This condition connects Relevance thresholds, individual changes and uncertainty with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 Relevance thresholds, individual changes and uncertainty 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 relevance thresholds, individual distributions, response definitions and persistence are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Did effects persist after four months?",
      "needed": "Assessment duration, intervention cessation and long-term follow-up",
      "role": "Required",
      "role_reason": "This condition connects Assessment duration, intervention cessation and long-term follow-up with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 Assessment duration, intervention cessation and long-term 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: ESS persistence beyond four months, post-intervention changes and long-term clinical outcomes have no linked material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Is AHI a separate result from ESS?",
      "needed": "Distinguishing ESS/AHI definitions, results and units",
      "role": "Required",
      "role_reason": "This condition connects Distinguishing ESS/AHI definitions, results and units with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 Distinguishing ESS/AHI definitions, results 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: Sleep-study methods, AHI calculation, condition-specific denominators and exact prior analysis plans are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Is the null PSQI result also retained?",
      "needed": "Endpoint-specific effects, units and uncertainty",
      "role": "Required",
      "role_reason": "This condition connects Endpoint-specific effects, units and uncertainty with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 Endpoint-specific effects, units and uncertainty 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: PSQI procedures, denominators, model and prespecified hierarchy are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Are the bed-partner respondent and endpoint distinguished?",
      "needed": "Respondent, scale, endpoint and denominators",
      "role": "Required",
      "role_reason": "This condition connects Respondent, scale, endpoint and denominators with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 Respondent, scale, endpoint 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: Bed-partner denominators, scale, exact CIs/P values, masking and prior hierarchy are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Does completion by everyone establish every analysis denominator?",
      "needed": "Allocation, completion, endpoint analyses and missingness",
      "role": "Required",
      "role_reason": "This condition connects Allocation, completion, endpoint analyses and missingness with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 Allocation, completion, endpoint analyses and missingness 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: Arm allocation, endpoint analysis denominators, missingness, ITT/PP and exclusion reasons are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Are concurrent treatment, weight and lifestyle changes verified?",
      "needed": "Arm-specific concurrent care, exposure and adjustment",
      "role": "Required",
      "role_reason": "This condition connects Arm-specific concurrent care, exposure and adjustment with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 Arm-specific concurrent care, exposure and adjustment 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: Concurrent therapy, weight/activity changes, medication, baseline adjustment and adherence are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "When was ISRCTN registration made?",
      "needed": "Registration identity, recruitment/registration timing and original records",
      "role": "Required",
      "role_reason": "This condition connects Registration identity, recruitment/registration timing and original records with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 identity, recruitment/registration timing and original records 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: Exact recruitment/registration dates, original registration and change-history details remain unread. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Does an ESS main endpoint establish the complete prior plan?",
      "needed": "Separating main-endpoint wording, registration, protocol and SAP",
      "role": "Required",
      "role_reason": "This condition connects Separating main-endpoint wording, registration, protocol and SAP with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 Separating main-endpoint wording, registration, protocol and SAP 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 ESS hierarchy, protocol, SAP, change history and analysis plans are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Are multiple endpoints and test models distinguished?",
      "needed": "All endpoints, tests, adjustment and multiplicity",
      "role": "Required",
      "role_reason": "This condition connects All endpoints, tests, adjustment and multiplicity with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 All endpoints, tests, adjustment 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: Test direction, exact models, covariates, multiplicity and prior plans for additional endpoints are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Are the paper and registration separate trials?",
      "needed": "Reports, registration, trial family and population links",
      "role": "Required",
      "role_reason": "This condition connects Reports, registration, trial family and population links with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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, trial family and population links 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 original/registration plans and correspondence between analyses remain externally unread. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Was the sleepiness effect independently replicated?",
      "needed": "Separate trials with the same population/intervention/comparator",
      "role": "Required",
      "role_reason": "This condition connects Separate trials with the same population/intervention/comparator with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 Separate trials with the same population/intervention/comparator 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: Separate replication under the same conditions and actual trial-family independence are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Does this apply to other BMIs, severities or ages?",
      "needed": "Direct population-specific material and subgroup plans",
      "role": "Required",
      "role_reason": "This condition connects Direct population-specific material and subgroup plans with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 population-specific material and subgroup plans 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 ESS, AHI, safety and prior subgroup plans have no linked material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Do sleepiness/AHI signals establish replacement of standard therapy?",
      "needed": "Direct standard-treatment comparisons and clinical outcomes",
      "role": "Required",
      "role_reason": "This condition connects Direct standard-treatment comparisons and clinical outcomes with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 standard-treatment comparisons 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: Direct standard-treatment comparisons, noninferiority and long-term clinical outcomes have no linked material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Are funding, the developer-instructor and conflicts distinguished?",
      "needed": "Original support, product, employee/developer and COI records",
      "role": "Required",
      "role_reason": "This condition connects Original support, product, employee/developer and COI records with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 Original support, product, employee/developer and COI records 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: Funding roles, equipment/instrument support, developer-instructor roles, employee authors, COI and analysis/reporting involvement are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "What was reported about safety and sample-size limits?",
      "needed": "Harm collection, exposure, arm denominators and follow-up",
      "role": "Supplementary",
      "role_reason": "This condition connects Harm collection, exposure, arm denominators and follow-up with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 Harm collection, exposure, arm 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: Collection methods, event definitions, arm denominators, rare/long-term harms and treatment-cessation material are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N26",
      "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/subclaim original values and historical dates with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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": "N27",
      "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 statements, summary use and external access with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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": "N28",
      "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 Linking summary reading, unread originals and needed material with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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."
    }
  ]
}