{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v2991-s1",
  "verdict_number": "2991",
  "title": "Didgeridoo training × replacement for standard OSA therapy",
  "view_version": "1.0",
  "view_created_date": "2026-10-16",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "review_date": null,
  "legacy_evidence_date": "2026-09-07",
  "review_scope": {
    "materials_read": "Existing review summaries and stored records of methodological application",
    "clinical_papers_directly_read": false,
    "new_clinical_search": false,
    "limitation": "Existing stored summary and preserved methodology application records. External papers, abstracts, registration, protocols, SAPs, original result tables and support disclosures are unread, and review of existing content remains incomplete.",
    "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature."
  },
  "claim_context": {
    "population": "The original trial records 25 adults with moderate OSA, BMI below 30 and AHI 15–30/h, all completing follow-up. Population, denominators and baseline therapy for a direct treatment-replacement comparison are unlinked. This is not generalized to all OSA patients or severities.",
    "intervention": "A structured didgeridoo lesson/home-practice program. This is not converted into a specific instrument-brand effect or equivalent effects from all playing/breathing training. Components, contact, individual actual practice and adherence are unverified. No new playing/breathing methods or procedures are created.",
    "dose": "Original mean 5.9 days weekly, 25.3 minutes per session and approximately 25 minutes in the intervention name are preserved only as study exposure. Plans, individual distributions, discontinuation and adherence details are unverified. Means do not become identical exposure for everyone or a recommended schedule; total time, frequency and individual intensity are not newly converted.",
    "comparator": "A four-month wait-list control. Contact, expectation differences and concurrent-treatment details are unverified. This is not converted into direct comparisons, equivalence or treatment-replacement effects versus standard CPAP, oral appliances, other instruments or equal-contact sham.",
    "endpoint": "The selected question is replacement for standard OSA therapy, with original grade '?' and note 'No direct comparison with standard therapy was performed.' Existing ESS, AHI, PSQI and bed-partner results are separate endpoints of a wait-list trial. Direct replacement estimands, hypotheses, noninferiority margins and clinical outcomes are unlinked. Original signals are not converted into equivalence, cure, successful replacement or zero effect.",
    "duration": "The original four-month trial with all 25 completing did not test long-term complication prevention, sustained replacement or safety of stopping established treatment. Short-term symptom/sleep-study signals are distinguished from the long-term clinical question of replacing standard therapy.",
    "excluded_extensions": [
      "Mixing ESS points, AHI/h, PSQI and bed-partner assessment as the same unit, respondent, endpoint or cure rate",
      "Converting wait-list ESS/AHI signals or alternative treatment in paper/registration titles into direct comparisons, equivalence, noninferiority or successful replacement versus CPAP/oral appliances",
      "Filling arm n, every endpoint denominator or ITT from all 25 completing, or adding paper/registration/two subclaim sheets as independent trials/participants",
      "Inheriting retrospective registration or original historical checks as prerecruitment plans, current external reading or completed clinical review",
      "Extending parent C50, Good and axes into subclaim scores, all BMIs/severities, long-term clinical effects or safety",
      "Creating new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions",
      "Converting the original '?' for untested replacement into a new D grade, zero effect, established failure, cure or treatment recommendation"
    ]
  },
  "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.",
      "current_reports": [
        "S01",
        "S02"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The selected original subclaim is 'Replacement for standard OSA therapy', with grade '?' and note 'No direct comparison with standard therapy was performed.' Parent C50 and sleepiness C do not fill the grade or score for this question.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Subclaim score, status and axes are absent from the original. Direct evidence for replacing standard therapy is unlinked.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Subclaim score, status and axes are absent from the original. Direct evidence for replacing standard therapy is unlinked."
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The existing trial compared didgeridoo lessons/home practice with a wait list over four months. Wait-list results are not converted into direct comparisons with CPAP or oral appliances.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Direct-comparison design, interventions, denominators and original results for standard therapy are unlinked.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Direct-comparison design, interventions, denominators and original results for standard therapy are unlinked."
    },
    {
      "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.",
      "current_reports": [
        "S01",
        "S02"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The original states that noninferiority or replacement versus standard therapies such as CPAP or oral appliances was not tested. Symptom significance is not transferred into proof of equivalence or noninferiority.",
      "condition_status": "Unverified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Prior comparative hypotheses, noninferiority margins, testing plans and direct estimands are unlinked.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Prior comparative hypotheses, noninferiority margins, testing plans and direct estimands are unlinked."
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The existing trial involved 25 adults with moderate OSA, BMI below 30 and AHI 15–30/h. It is not extended to replacement for every population or severity requiring standard therapy.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Eligibility, baseline therapy, severity, risk and denominators corresponding to a replacement comparison are unlinked.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Eligibility, baseline therapy, severity, risk and denominators corresponding to a replacement comparison are unlinked."
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The existing evidence concerns a lesson/home-practice program rather than a specific brand. General instrument playing, breathing activities and other programs are not treated as the same replacement intervention.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Program components and exposure/adherence in direct comparisons with standard therapy are unlinked.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Program components and exposure/adherence in direct comparisons with standard therapy are unlinked."
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "Mean 5.9 days per week and 25.3 minutes per session are original study records. They are not used as a recommended duration, training prescription or dose for replacing standard therapy.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Individual adherence, exposure distributions and actual use conditions in direct comparisons are unverified.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Individual adherence, exposure distributions and actual use conditions in direct comparisons are unverified."
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "ESS −3.0 points (95% CI −5.7 to −0.3, P=.03) is the original result versus a wait list. It is not transferred into a difference versus standard therapy, equivalent effects or successful replacement.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "ESS effects versus standard therapy, denominators, CIs and prior agreements are unlinked.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "ESS effects versus standard therapy, denominators, CIs and prior agreements are unlinked."
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "AHI −6.2/h (−12.3 to −0.1, P=.05) is a separate signal from the existing wait-list comparison. It is not used as normalization, cure, equal effects to standard therapy or elimination of long-term risk.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "AHI from direct treatment comparisons, normalization/response criteria and long-term clinical endpoints are unlinked.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "AHI from direct treatment comparisons, normalization/response criteria and long-term clinical endpoints are unlinked."
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The existing PSQI −0.7 points (−2.1 to 0.6, P=.27) was null. ESS/AHI signals do not create improved overall sleep quality or success on all replacement-related endpoints.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Overall sleep/symptom results, endpoint hierarchy and denominators in direct comparisons are unlinked.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Overall sleep/symptom results, endpoint hierarchy and denominators in direct comparisons are unlinked."
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The original bed-partner sleep-disturbance result of −2.8 points is subjective. It is not converted into patient ESS, objective AHI or direct confirmation of replacement for standard therapy.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Respondent denominators, scale, exact CI/P and the replacement-comparison agreement are unverified.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Respondent denominators, scale, exact CI/P and the replacement-comparison agreement are unverified."
    },
    {
      "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.",
      "current_reports": [
        "S01",
        "S02"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The original material contains symptom/test signals from a trial that did not test replacement. Prior estimands and analysis agreements versus standard therapy are absent from the current stored summary.",
      "condition_status": "Unverified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Definition of replacement, comparative endpoints, analysis populations, estimands and observation windows are unlinked.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Definition of replacement, comparative endpoints, analysis populations, estimands and observation windows are unlinked."
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The original wait-list comparison is not converted into a detailed agreement for stopping or combining standard therapy. The original states that the trial did not assess safety of arbitrarily stopping established therapy.",
      "condition_status": "Unverified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Baseline/concurrent therapies, changes, rescue exposure and direct-comparison conditions are unverified.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Baseline/concurrent therapies, changes, rescue exposure and direct-comparison conditions are unverified."
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The existing trial used a randomized wait list and participants knew their intervention. An unblinded sleepiness signal does not establish the same bias conditions in comparisons with standard therapy.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Allocation concealment, contact/expectation differences, assessor/analyst masking and direct-comparison conditions are unverified.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Allocation concealment, contact/expectation differences, assessor/analyst masking and direct-comparison conditions are unverified."
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The original record that all 25 completed is preserved. It is not extended to arm n, complete analysis of every endpoint, noninferiority analysis denominators or adequate scale.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Allocation by arm, endpoint analyses, ITT/PP, missingness and separate-comparison denominator/size agreements are unverified.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Allocation by arm, endpoint analyses, ITT/PP, missingness and separate-comparison denominator/size agreements are unverified."
    },
    {
      "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.",
      "current_reports": [
        "S01",
        "S02"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The original states that ISRCTN31571714 registration followed recruitment. 'Alternative treatment' in its title is not interpreted as a direct standard-therapy comparison or prior noninferiority agreement.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Prerecruitment replacement hypotheses, comparison plans, exact registration/recruitment dates and change history remain unread.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Prerecruitment replacement hypotheses, comparison plans, exact registration/recruitment dates and change history remain unread."
    },
    {
      "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.",
      "current_reports": [
        "S01",
        "S02"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The evidence record's four-month ESS main outcome and AHI/PSQI are preserved. This hierarchy is not transferred into a prior first endpoint or success criterion for replacement, or verification of the complete analysis plan.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Prerecruitment plans, analysis models, multiplicity and replacement-related outcome agreements are unverified.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Prerecruitment plans, analysis models, multiplicity and replacement-related outcome agreements are unverified."
    },
    {
      "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.",
      "current_reports": [
        "S01",
        "S02"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "S01 Puhan 2006 and S02 ISRCTN31571714 are paper/registration slots for the same 25-person four-month trial. They are shared by the sleepiness and replacement sheets, not added as new independent trials, participants or replications.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Detailed analysis correspondence between external paper and registration remains unread.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Detailed analysis correspondence between external paper and registration remains unread."
    },
    {
      "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.",
      "current_reports": [
        "S01",
        "S02"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The existing original states that there was no independent replication or direct comparison with standard therapy. One trial, multiple endpoints and registration bibliography do not become independent confirmation of replacement.",
      "condition_status": "Unverified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Direct comparison for the replacement question, its separate replication and family independence are unlinked.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Direct comparison for the replacement question, its separate replication and family independence are unlinked."
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The existing four-month assessment did not test long-term complication prevention, sustained effects or long-term replacement for standard therapy. Measure signals are not transferred into long-term clinical events.",
      "condition_status": "Unverified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Long-term direct comparisons, clinical events and persistence after intervention cessation are unlinked.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Long-term direct comparisons, clinical events and persistence after intervention cessation are unlinked."
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The direct population was selected adults with moderate OSA and BMI below 30. Replacement for standard therapy is not generalized to all OSA patients, other severities or other conditions.",
      "condition_status": "Unverified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Population-specific direct comparisons, denominators and clinical/safety outcomes are unlinked.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Population-specific direct comparisons, denominators and clinical/safety outcomes are unlinked."
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "Zurich Lung Association/clinical support and a training-developer instructor among the authors are recorded. Support information does not fill replacement evidence or verification of all interests/independence.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Original material on funder roles, instrument/product support, developer-instructor roles, employee authors and COI is unverified.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original material on funder roles, instrument/product support, developer-instructor roles, employee authors and COI is unverified."
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "Parent safety 'Good' and no reported unexpected adverse reactions/events among 25 people over four months are original wording. The same original states that safety of arbitrarily stopping established OSA treatment was not assessed.",
      "condition_status": "Unverified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Rare/long-term harms, direct replacement comparisons, stopping risks and arm-specific collection/denominators are unverified.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Rare/long-term harms, direct replacement comparisons, stopping risks and arm-specific collection/denominators are unverified."
    },
    {
      "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.",
      "current_reports": [
        "S01",
        "S02"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The subclaim '?' records that no direct comparison with standard therapy was performed. It is not converted into zero effect, established failure, cure, equivalence, a new D grade or treatment recommendations.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Comparative effects, uncertainty and clinical judgment material for the direct replacement question are unlinked.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Comparative effects, uncertainty and clinical judgment material for the direct replacement question are unlinked."
    },
    {
      "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.",
      "current_reports": [
        "S01",
        "S02"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "Parent C50, B/P/R1/I1/E+/B2/CX, four false flags and empty override, plus subclaim '?' and note are preserved. Original Korean/English wording, 2026-09-07, an empty corrections array and empty deliberation string are not inherited as the current review date or subclaim score.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Subclaim score, status and axes are absent from the original. New corrections and external original-text comparisons were not performed.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Subclaim score, status and axes are absent from the original. New corrections and external original-text comparisons were not performed."
    },
    {
      "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.",
      "current_reports": [
        "S01",
        "S02"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "Original primary-trial, ISRCTN and effect-size verification is preserved as historical wording. Stored summaries/bibliography were used here; original papers, registration, protocols, SAPs and COI remain unread without access attempts.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Historical-check details, current external-original acquisition/reading and content review remain incomplete.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Historical-check details, current external-original acquisition/reading and content review remain incomplete."
    },
    {
      "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.",
      "current_reports": [
        "S01",
        "S02"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "Original paper/ISRCTN URLs are retained and actual reading is distinguished as summary read versus external material unread. URL presence alone does not raise verification status.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "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.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    }
  ],
  "reports": [
    {
      "report_id": "S01",
      "title": "Puhan MA et al. BMJ 2006",
      "url": "https://pubmed.ncbi.nlm.nih.gov/16377643/",
      "report_type": "Randomized wait-list controlled trial",
      "existence": "The stored evidence/citation lists contain the original paper bibliography. External public availability and access status are unverified in this work.",
      "acquired_read": "Stored summaries read; original external papers, registration, protocols, SAPs and COI unread without access attempts",
      "study_family": "RG2991-PUHAN-ISRCTN31571714",
      "independent_replication": "The same paper/registration, 25 people, four months, multiple endpoints and two subclaim sheets are not counted as new independent trials, participants or replications. Confirmed unique-trial, participant and independent-replication totals are unrecorded; review of existing content remains incomplete.",
      "observed_result": "ESS −3.0 points (−5.7 to −0.3); AHI −6.2/h (−12.3 to −0.1); PSQI null",
      "result_level": "Preserved original-paper result summary, containing ESS/AHI/PSQI signals versus a wait list. It is not a direct effect report for replacing standard OSA therapy; arm denominators, exact models and prior replacement agreements are unverified.",
      "source_evidence_date": "2026-09-07",
      "materials": [
        {
          "material_type": "Stored existing review summary",
          "public_status": "Preserved copy of the complete parent-verdict stored summary",
          "access_status": "Stored summary",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-09-07",
          "qualification": "Original PubMed URL, PMID 16377643, PMCID PMC1360393, DOI 10.1136/bmj.38705.470590.55 and same-trial ISRCTN31571714 link are preserved. Identifiers alone do not certify current reading, acquisition, prior plans or condition fulfillment, and new URLs are not inferred."
        },
        {
          "material_type": "External paper",
          "public_status": "Original bibliographic link or needed material; external public availability/access status unverified",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-09-07",
          "qualification": "Original PubMed URL, PMID 16377643, PMCID PMC1360393, DOI 10.1136/bmj.38705.470590.55 and same-trial ISRCTN31571714 link are preserved. Identifiers alone do not certify current reading, acquisition, prior plans or condition fulfillment, and new URLs are not inferred."
        },
        {
          "material_type": "Registration material",
          "public_status": "Original bibliographic link or needed material; external public availability/access status unverified",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-09-07",
          "qualification": "Original PubMed URL, PMID 16377643, PMCID PMC1360393, DOI 10.1136/bmj.38705.470590.55 and same-trial ISRCTN31571714 link are preserved. Identifiers alone do not certify current reading, acquisition, prior plans or condition fulfillment, and new URLs are not inferred."
        },
        {
          "material_type": "Protocol",
          "public_status": "Original bibliographic link or needed material; external public availability/access status unverified",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-09-07",
          "qualification": "Original PubMed URL, PMID 16377643, PMCID PMC1360393, DOI 10.1136/bmj.38705.470590.55 and same-trial ISRCTN31571714 link are preserved. Identifiers alone do not certify current reading, acquisition, prior plans or condition fulfillment, and new URLs are not inferred."
        },
        {
          "material_type": "Statistical analysis plan",
          "public_status": "Original bibliographic link or needed material; external public availability/access status unverified",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-09-07",
          "qualification": "Original PubMed URL, PMID 16377643, PMCID PMC1360393, DOI 10.1136/bmj.38705.470590.55 and same-trial ISRCTN31571714 link are preserved. Identifiers alone do not certify current reading, acquisition, prior plans or condition fulfillment, and new URLs are not inferred."
        },
        {
          "material_type": "Funding, product-support and COI material",
          "public_status": "Original bibliographic link or needed material; external public availability/access status unverified",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-09-07",
          "qualification": "Original PubMed URL, PMID 16377643, PMCID PMC1360393, DOI 10.1136/bmj.38705.470590.55 and same-trial ISRCTN31571714 link are preserved. Identifiers alone do not certify current reading, acquisition, prior plans or condition fulfillment, and new URLs are not inferred."
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/16377643/"
        }
      ]
    },
    {
      "report_id": "S02",
      "title": "ISRCTN31571714. Didgeridoo playing as alternative treatment for obstructive sleep apnoea syndrome.",
      "url": "https://www.isrctn.com/ISRCTN31571714",
      "report_type": "Registration bibliography for the same trial; not a separate clinical-effect report",
      "existence": "The original citation list contains ISRCTN bibliography for the same trial. Presence of a registration URL is distinguished from current external reading or content verification.",
      "acquired_read": "Stored summaries read; original external papers, registration, protocols, SAPs and COI unread without access attempts",
      "study_family": "RG2991-PUHAN-ISRCTN31571714",
      "independent_replication": "The same paper/registration, 25 people, four months, multiple endpoints and two subclaim sheets are not counted as new independent trials, participants or replications. Confirmed unique-trial, participant and independent-replication totals are unrecorded; review of existing content remains incomplete.",
      "observed_result": "The original citation historically states that registration timing and multiple-endpoint descriptions were checked. This does not establish current registration reading or newly verified clinical effects.",
      "result_level": "Historical verification wording in preserved registration bibliography, linked to the same trial. The original statement that registration followed recruitment is retained. Exact recruitment/registration dates, change history, protocol and SAP remain unread; no separate effects, CIs or independent trials are created.",
      "source_evidence_date": "2026-09-07",
      "materials": [
        {
          "material_type": "Stored existing review summary",
          "public_status": "Preserved copy of the complete parent-verdict stored summary",
          "access_status": "Stored summary",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-09-07",
          "qualification": "The original ISRCTN31571714 URL is preserved. It registers the same Puhan 2006, 25-person four-month trial, not separate participants or an effect report. Original post-recruitment registration wording is distinguished from currently unread exact dates/plans."
        },
        {
          "material_type": "External registration material",
          "public_status": "Original bibliographic link or needed material; external public availability/access status unverified",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-09-07",
          "qualification": "The original ISRCTN31571714 URL is preserved. It registers the same Puhan 2006, 25-person four-month trial, not separate participants or an effect report. Original post-recruitment registration wording is distinguished from currently unread exact dates/plans."
        },
        {
          "material_type": "Registration amendment history",
          "public_status": "Original bibliographic link or needed material; external public availability/access status unverified",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-09-07",
          "qualification": "The original ISRCTN31571714 URL is preserved. It registers the same Puhan 2006, 25-person four-month trial, not separate participants or an effect report. Original post-recruitment registration wording is distinguished from currently unread exact dates/plans."
        },
        {
          "material_type": "Protocol",
          "public_status": "Original bibliographic link or needed material; external public availability/access status unverified",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-09-07",
          "qualification": "The original ISRCTN31571714 URL is preserved. It registers the same Puhan 2006, 25-person four-month trial, not separate participants or an effect report. Original post-recruitment registration wording is distinguished from currently unread exact dates/plans."
        },
        {
          "material_type": "Statistical analysis plan",
          "public_status": "Original bibliographic link or needed material; external public availability/access status unverified",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-09-07",
          "qualification": "The original ISRCTN31571714 URL is preserved. It registers the same Puhan 2006, 25-person four-month trial, not separate participants or an effect report. Original post-recruitment registration wording is distinguished from currently unread exact dates/plans."
        },
        {
          "material_type": "Funding, product-support and COI material",
          "public_status": "Original bibliographic link or needed material; external public availability/access status unverified",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-09-07",
          "qualification": "The original ISRCTN31571714 URL is preserved. It registers the same Puhan 2006, 25-person four-month trial, not separate participants or an effect report. Original post-recruitment registration wording is distinguished from currently unread exact dates/plans."
        }
      ],
      "links": [
        {
          "label": "Official source",
          "url": "https://www.isrctn.com/ISRCTN31571714"
        }
      ]
    }
  ],
  "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",
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      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
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      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
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      "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"
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      "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"
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    {
      "id": "M19",
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      "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"
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  "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."
  },
  "study_overlap": {
    "state": "Unverified",
    "unique_trial_count": null,
    "unique_participant_count": null,
    "reason": "The S01 Puhan 2006 paper and S02 ISRCTN31571714 registration are preserved links to the same 25-person four-month didgeridoo lesson/home-practice versus wait-list trial. ESS, AHI, PSQI, bed-partner endpoints, two subclaim sheets and registration are not added as new independent trials, participants or replications. Detailed originals/registration remain externally unread; confirmed unique-trial, participant and independent-replication totals are unrecorded."
  },
  "history": [
    {
      "date": "2026-10-16",
      "kind": "Separation of public-facing pages and materials",
      "view_version": "1.0",
      "change": "The reader view and materials were prepared from the existing 26 items. No new clinical search, verification-status changes or scoring were performed."
    }
  ],
  "language": "en",
  "translation_date": "2026-10-16"
}