{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v2922-s1",
  "verdict_number": "2922",
  "title": "Insulin degludec × Severe hypoglycemia — direct maintenance-period evidence sheet",
  "view_version": "1.0",
  "view_created_date": "2026-10-10",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "review_date": null,
  "legacy_evidence_date": "2026-08-26",
  "review_scope": {
    "materials_read": "Existing review summaries and stored records of methodological application",
    "clinical_papers_directly_read": false,
    "new_clinical_search": false,
    "limitation": "The complete existing review summary was read for production and original URLs/identifiers were linked. External abstracts, full texts, registration, protocols and SAPs were not newly read or checked.",
    "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": "Type 2 diabetes with hypoglycemia risk; detailed eligibility, baseline characteristics and risk subgroups remain unread",
    "intervention": "Historical crossover-trial exposure to insulin degludec; not a recommendation on selection or use",
    "dose": "Original detailed doses, titration and administration times remain unread; no individual regimen, injection or dose-adjustment instructions",
    "comparator": "Active insulin glargine U100 control; two-period crossover in the same patients; detailed shared concurrent treatment remains unread",
    "endpoint": "Proportion of patients experiencing severe hypoglycemia during 16-week maintenance, difference/CI/P; distinguished from the overall-endpoint effect",
    "duration": "Each 32-week period: initial 16-week titration and 16-week maintenance primary analysis; other periods/long-term follow-up remain separate gaps",
    "excluded_extensions": [
      "Transferring the overall symptomatic composite effect to severe-only, HbA1c or long-term outcomes",
      "Mixing event rates, patient proportions, contributors, FAS and completers",
      "Correcting the original rate difference −23.66 using simple arithmetic",
      "Adding two periods, the same people or recurrent events as new independent observations",
      "Recommendations on insulin, doses, titration, injections, treatment choice, coverage or costs"
    ]
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Comparative efficacy",
      "question": "Are subclaim C/D, original notes and parent C50/axes distinguished?",
      "needed": "Separate preservation of the selected claim, grade, note, absent values and parent values",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Separate preservation of the selected claim, grade, note, absent values and parent values",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Additional material is linked with each selected question and parent context distinguished.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Selected severe hypoglycemia subclaim D has a note of maintenance-period 1.6% versus 2.4%, P=.35. It is distinguished from parent C50, safety caution and the original overall symptomatic verdict.",
      "condition_status": "Partly verified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Absent subclaim scores, status and axes are not filled with parent values. There is no new split, verdict, grade or independent certification.",
      "missingness": "Absent subclaim scores, status and axes are not filled with parent values. There is no new split, verdict, grade or independent certification.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Absent subclaim scores, status and axes are not filled with parent values. There is no new split, verdict, grade or independent certification."
    },
    {
      "item_id": "N02",
      "question_type": "Comparative efficacy",
      "question": "What are the actual population and baseline characteristics of type 2 diabetes with hypoglycemia risk?",
      "needed": "Eligibility, risk criteria, baseline insulin, concurrent drugs and denominators",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Eligibility, risk criteria, baseline insulin, concurrent drugs and denominators",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Acquire original eligibility, baseline characteristics, risk criteria, concurrent exposure and denominators.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "SWITCH2 is an insulin comparison trial in type 2 diabetes with hypoglycemia risk.",
      "condition_status": "Partly verified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Detailed risk eligibility, previous hypoglycemia, baseline medication, renal/age/comorbidity characteristics and group/sequence composition are absent from the summary. Results are not automatically extended to other populations.",
      "missingness": "Detailed risk eligibility, previous hypoglycemia, baseline medication, renal/age/comorbidity characteristics and group/sequence composition are absent from the summary. Results are not automatically extended to other populations.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Detailed risk eligibility, previous hypoglycemia, baseline medication, renal/age/comorbidity characteristics and group/sequence composition are absent from the summary. Results are not automatically extended to other populations."
    },
    {
      "item_id": "N03",
      "question_type": "Comparative efficacy",
      "question": "What is the direct comparison between degludec and glargine U100?",
      "needed": "Original drugs, formulations, active control, shared treatment and actual exposure",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Original drugs, formulations, active control, shared treatment and actual exposure",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Acquire original drugs, formulations, active control, concurrent treatment, changes and actual exposure.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The existing citation compares insulin degludec with insulin glargine U100; each patient received both insulins sequentially.",
      "condition_status": "Partly verified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. This is not changed to other concentrations, other insulins, treatment discontinuation or no-insulin comparison. Product, dose, shared concurrent treatment and treatment-change details remain unread; no selection or regimen instructions are given.",
      "missingness": "This is not changed to other concentrations, other insulins, treatment discontinuation or no-insulin comparison. Product, dose, shared concurrent treatment and treatment-change details remain unread; no selection or regimen instructions are given.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "This is not changed to other concentrations, other insulins, treatment discontinuation or no-insulin comparison. Product, dose, shared concurrent treatment and treatment-change details remain unread; no selection or regimen instructions are given."
    },
    {
      "item_id": "N04",
      "question_type": "Comparative efficacy",
      "question": "What are the sequence, same-person and analysis relationships in the two-period crossover?",
      "needed": "Assigned sequences, each period, treatment-specific contributions, correlation and denominators",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Assigned sequences, each period, treatment-specific contributions, correlation and denominators",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Acquire original sequence allocation, period/treatment contributions, correlations, models and denominators.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The original randomized double-blind two-period crossover design gives both treatments to the same people.",
      "condition_status": "Partly verified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Two periods, treatment-specific analyses and two questions are not added as new people or independent trials. Original sequence counts, period/sequence models, treatment changes and censoring remain unread.",
      "missingness": "Two periods, treatment-specific analyses and two questions are not added as new people or independent trials. Original sequence counts, period/sequence models, treatment changes and censoring remain unread.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Two periods, treatment-specific analyses and two questions are not added as new people or independent trials. Original sequence counts, period/sequence models, treatment changes and censoring remain unread."
    },
    {
      "item_id": "N05",
      "question_type": "Comparative efficacy",
      "question": "Are each 32-week period, 16-week titration and 16-week maintenance windows distinguished?",
      "needed": "Original periods, titration, maintenance, primary window and actual exposure",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Original periods, titration, maintenance, primary window and actual exposure",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Acquire original period-specific plans, actual exposure, observation windows, denominators and analyses.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The existing summary says the initial 16 weeks of each 32-week period were for titration, with only maintenance used in primary analysis. The evidence entry concerns the 16-week maintenance endpoint.",
      "condition_status": "Partly verified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Time in the two periods is not newly added, and titration/full-period values are not moved into maintenance results. No titration method, usage instruction or actual period/exposure is invented.",
      "missingness": "Time in the two periods is not newly added, and titration/full-period values are not moved into maintenance results. No titration method, usage instruction or actual period/exposure is invented.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Time in the two periods is not newly added, and titration/full-period values are not moved into maintenance results. No titration method, usage instruction or actual period/exposure is invented."
    },
    {
      "item_id": "N06",
      "question_type": "Comparative efficacy",
      "question": "Are carryover-mitigation plans distinguished from gaps on residual effects?",
      "needed": "Original titration plans, period effects, residual effects, sequence and sensitivity",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Original titration plans, period effects, residual effects, sequence and sensitivity",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Acquire original period/sequence, carryover, titration and sensitivity plans/results.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The existing summary describes crossover’s reduction of between-person variation, possible carryover and a 16-week titration plan to reduce it. It records that crossover itself was not a listed defect.",
      "condition_status": "Partly verified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. A titration plan alone does not newly certify zero carryover or complete resolution. Washout, period/sequence tests and sensitivity details remain unread.",
      "missingness": "A titration plan alone does not newly certify zero carryover or complete resolution. Washout, period/sequence tests and sensitivity details remain unread.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "A titration plan alone does not newly certify zero carryover or complete resolution. Washout, period/sequence tests and sensitivity details remain unread."
    },
    {
      "item_id": "N07",
      "question_type": "Comparative efficacy",
      "question": "Are 721 randomized, 720 FAS, 580 completed and treatment-specific 632/618 distinguished?",
      "needed": "Randomized, FAS, completers, contributors and each treatment/period denominator",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Randomized, FAS, completers, contributors and each treatment/period denominator",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Acquire original flow, treatment/period contributions, sequences, population definitions and denominators.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The existing evidence list gives 721 randomized, 720 FAS and 580 completed. The original Korean article records treatment-specific primary contributors of 632 and 618.",
      "condition_status": "Partly verified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. 632/618 are not newly mapped to treatment names absent from the existing summary or added as different people. FAS720, completed580 and primary contributors do not substitute for the same population.",
      "missingness": "632/618 are not newly mapped to treatment names absent from the existing summary or added as different people. FAS720, completed580 and primary contributors do not substitute for the same population.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "632/618 are not newly mapped to treatment names absent from the existing summary or added as different people. FAS720, completed580 and primary contributors do not substitute for the same population."
    },
    {
      "item_id": "N08",
      "question_type": "Comparative efficacy",
      "question": "What are the limits of completed 80.4%, not completed 19.6% and original missing-data handling?",
      "needed": "Completion, discontinuation reasons, treatment/period missingness, models and sensitivity",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Completion, discontinuation reasons, treatment/period missingness, models and sensitivity",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Acquire original discontinuation, missingness, imputation/sensitivity assumptions, populations, effects and intervals.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "580/721 completed, 80.4%; not completed, 19.6%; and ITT/missingness-sensitivity analyses are retained as described in the original article.",
      "condition_status": "Partly verified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. No new dropout rate, group missingness or imputed values are calculated. Original missing-data analysis wording does not certify resolution of all missingness bias or complete follow-up.",
      "missingness": "No new dropout rate, group missingness or imputed values are calculated. Original missing-data analysis wording does not certify resolution of all missingness bias or complete follow-up.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "No new dropout rate, group missingness or imputed values are calculated. Original missing-data analysis wording does not certify resolution of all missingness bias or complete follow-up."
    },
    {
      "item_id": "N09",
      "question_type": "Comparative efficacy",
      "question": "What is the overall symptomatic endpoint definition involving severe or glucose-confirmed events?",
      "needed": "Severe events, third-party assistance, external adjudication, glucose/symptoms and event ascertainment",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Severe events, third-party assistance, external adjudication, glucose/symptoms and event ascertainment",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Acquire original definitions, external adjudication, combined symptoms/testing, people/recurrent events and periods.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The original primary endpoint is externally adjudicated severe events requiring third-party assistance, or events combining glucose <56mg/dL with symptoms.",
      "condition_status": "Partly verified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. This is not changed to a lab value alone, all asymptomatic hypoglycemia or severe events alone. Recurrent-event distinctions, ascertainment schedules and collection details remain unread.",
      "missingness": "This is not changed to a lab value alone, all asymptomatic hypoglycemia or severe events alone. Recurrent-event distinctions, ascertainment schedules and collection details remain unread.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "This is not changed to a lab value alone, all asymptomatic hypoglycemia or severe events alone. Recurrent-event distinctions, ascertainment schedules and collection details remain unread."
    },
    {
      "item_id": "N10",
      "question_type": "Comparative efficacy",
      "question": "What scales do 185.6/265.4 events, 0.70 and the 95% CI represent?",
      "needed": "Patient-time, event rates, original ratio, model, interval and denominator",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Patient-time, event rates, original ratio, model, interval and denominator",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Acquire original event/time tables, rate models, adjustment, group exposure, CIs and tests.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Overall symptomatic hypoglycemia during 16-week maintenance was 185.6 versus 265.4 events/100 patient-years; rate ratio 0.70 (95% CI 0.61–0.80).",
      "condition_status": "Partly verified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Event rates are not changed into patient proportions, risk ratios or total people. Recurrent events, patient-time, adjustment and detailed test P values are not invented.",
      "missingness": "Event rates are not changed into patient proportions, risk ratios or total people. Recurrent events, patient-time, adjustment and detailed test P values are not invented.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Event rates are not changed into patient proportions, risk ratios or total people. Recurrent events, patient-time, adjustment and detailed test P values are not invented."
    },
    {
      "item_id": "N11",
      "question_type": "Comparative efficacy",
      "question": "Was the original absolute rate difference −23.66 retained without recalculation as a simple difference?",
      "needed": "Original rate difference, model, scale, denominator and uncertainty",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Original rate difference, model, scale, denominator and uncertainty",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Acquire original rate-difference calculation, model, denominator, period and interval.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The existing summary and evidence list separately record an absolute rate difference of −23.66 events/100 patient-years.",
      "condition_status": "Partly verified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. 185.6/265.4 are not subtracted again to replace/correct this original value. Calculation model, adjustment, CI and P value are not filled in if unspecified.",
      "missingness": "185.6/265.4 are not subtracted again to replace/correct this original value. Calculation model, adjustment, CI and P value are not filled in if unspecified.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "185.6/265.4 are not subtracted again to replace/correct this original value. Calculation model, adjustment, CI and P value are not filled in if unspecified."
    },
    {
      "item_id": "N12",
      "question_type": "Comparative efficacy",
      "question": "Are affected-patient proportions 22.5%/31.6% and original −9.1%p distinguished?",
      "needed": "Affected patients, at least one event, denominator, period, difference and interval",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Affected patients, at least one event, denominator, period, difference and interval",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Acquire original affected-patient definitions, group denominators, event mapping, original difference/interval and tests.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Patients experiencing overall symptomatic events were 22.5% versus 31.6%; the original absolute difference was −9.1%p.",
      "condition_status": "Partly verified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. This proportion is not converted to a recurrent-event rate, severe proportion or new patient count. No new NNT, difference CI, P value or absolute-event example is created.",
      "missingness": "This proportion is not converted to a recurrent-event rate, severe proportion or new patient count. No new NNT, difference CI, P value or absolute-event example is created.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "This proportion is not converted to a recurrent-event rate, severe proportion or new patient count. No new NNT, difference CI, P value or absolute-event example is created."
    },
    {
      "item_id": "N13",
      "question_type": "Comparative efficacy",
      "question": "Are severe 1.6%/2.4%, −0.8%p, CI and P retained in their original scope?",
      "needed": "Severe definition requiring third-party assistance, patient proportions, original denominators, difference, CI and P",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Severe definition requiring third-party assistance, patient proportions, original denominators, difference, CI and P",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Acquire original severe events, affected patients, denominators, periods, difference/interval and tests.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Patients experiencing severe events during maintenance were 1.6% versus 2.4%; difference −0.8%p (95% CI −2.2–0.5; P=.35).",
      "condition_status": "Partly verified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. This value is not changed to events/patient-year, overall symptomatic effects or severe effects in other periods. No new people/event counts, rate ratios, CIs or P values are created.",
      "missingness": "This value is not changed to events/patient-year, overall symptomatic effects or severe effects in other periods. No new people/event counts, rate ratios, CIs or P values are created.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "This value is not changed to events/patient-year, overall symptomatic effects or severe effects in other periods. No new people/event counts, rate ratios, CIs or P values are created."
    },
    {
      "item_id": "N14",
      "question_type": "Comparative efficacy",
      "question": "Are overall-endpoint improvement and severe-only uncertainty separated?",
      "needed": "Overall/components, hierarchy, denominators, original effects, tests and interpretation",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Overall/components, hierarchy, denominators, original effects, tests and interpretation",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Acquire original component-specific plans, effects, intervals, hierarchy and precision.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The existing summary says overall symptomatic outcomes improved but the severe maintenance-period difference was not significant. Subclaim C/D are distinguished.",
      "condition_status": "Partly verified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Overall effects, average glucose or mechanisms do not establish severe reduction; P=.35 is not judged as an exact zero effect or equivalence.",
      "missingness": "Overall effects, average glucose or mechanisms do not establish severe reduction; P=.35 is not judged as an exact zero effect or equivalence.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Overall effects, average glucose or mechanisms do not establish severe reduction; P=.35 is not judged as an exact zero effect or equivalence."
    },
    {
      "item_id": "N15",
      "question_type": "Comparative efficacy",
      "question": "Are secondary HbA1c noninferiority and primary hypoglycemia separated?",
      "needed": "Original secondary efficacy, noninferiority plans, periods, denominators and margins",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Original secondary efficacy, noninferiority plans, periods, denominators and margins",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Separately acquire original HbA1c plans, margins, group values, denominators, periods and tests.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The existing summary records HbA1c as a secondary efficacy endpoint, noninferior in both periods.",
      "condition_status": "Partly verified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. HbA1c is not promoted to primary hypoglycemia; values, margins, CIs, P values or overall/severe effects absent from the existing summary are not filled in.",
      "missingness": "HbA1c is not promoted to primary hypoglycemia; values, margins, CIs, P values or overall/severe effects absent from the existing summary are not filled in.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "HbA1c is not promoted to primary hypoglycemia; values, margins, CIs, P values or overall/severe effects absent from the existing summary are not filled in."
    },
    {
      "item_id": "N16",
      "question_type": "Comparative efficacy",
      "question": "What are the gaps in direct precision and event ascertainment for severe-only reduction?",
      "needed": "Severe definitions, external adjudication, patients/events, exposure, denominators and original effects",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Severe definitions, external adjudication, patients/events, exposure, denominators and original effects",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Acquire original severe-event adjudication, people/event tables, group denominators, periods, models and plans.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Original severe events required third-party assistance and external adjudication; affected patients during maintenance were 1.6%/2.4%, difference CI −2.2–0.5; P=.35.",
      "condition_status": "Partly verified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Overall symptomatic rates or HbA1c do not fill direct severe effects. Severe patient counts, recurrence, exposure time, other-period effects and CIs are not invented.",
      "missingness": "Overall symptomatic rates or HbA1c do not fill direct severe effects. Severe patient counts, recurrence, exposure time, other-period effects and CIs are not invented.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Overall symptomatic rates or HbA1c do not fill direct severe effects. Severe patient counts, recurrence, exposure time, other-period effects and CIs are not invented."
    },
    {
      "item_id": "N17",
      "question_type": "Comparative efficacy",
      "question": "What is actual access to primary/secondary hierarchy, multiplicity, registration and SAP?",
      "needed": "Original registration, protocol, SAP, primary/secondary outcomes, changes and models",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Original registration, protocol, SAP, primary/secondary outcomes, changes and models",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Acquire original registration, plans, hierarchy, multiplicity, models and changes.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The original registration identifier is NCT02030600; the primary endpoint is the 16-week maintenance overall symptomatic hypoglycemia rate.",
      "condition_status": "Partly verified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Registration, full text and plans were not newly read. Exact hierarchy, α, multiplicity, prespecified subgroups or changes for severe/other periods are not newly established.",
      "missingness": "Registration, full text and plans were not newly read. Exact hierarchy, α, multiplicity, prespecified subgroups or changes for severe/other periods are not newly established.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Registration, full text and plans were not newly read. Exact hierarchy, α, multiplicity, prespecified subgroups or changes for severe/other periods are not newly established."
    },
    {
      "item_id": "N18",
      "question_type": "Comparative efficacy",
      "question": "Are identical vials/syringes, double blinding and actual assessment distinguished?",
      "needed": "Allocation, concealment, masking, identical tools, adjudication and analysis",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Allocation, concealment, masking, identical tools, adjudication and analysis",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Acquire original allocation, masking, external adjudication, analysis and missingness.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The existing summary records double blinding, identical vials/syringes, ITT and missingness sensitivity as historical reasons for not counting additional defects.",
      "condition_status": "Partly verified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. This does not certify new completed review or absence of all bias. Successful masking, allocation concealment and analyst/adjudicator details remain unread.",
      "missingness": "This does not certify new completed review or absence of all bias. Successful masking, allocation concealment and analyst/adjudicator details remain unread.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "This does not certify new completed review or absence of all bias. Successful masking, allocation concealment and analyst/adjudicator details remain unread."
    },
    {
      "item_id": "N19",
      "question_type": "Comparative efficacy",
      "question": "Are Novo support, two employees and design/data/writing roles each preserved?",
      "needed": "Funding, drugs/in-kind support, employees, external analysis and design/data/medical writing",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Funding, drugs/in-kind support, employees, external analysis and design/data/medical writing",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Separately acquire original cash, drug/in-kind support, affiliations and design/data/analysis/writing disclosures.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Novo Nordisk support, 2 employee authors and involvement in design, data and medical writing are preserved as in the existing summary.",
      "condition_status": "Partly verified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Two employees are not certified as independent authors, and funding alone does not fill trial-drug provision or external-analysis roles. Parent I0 is also preserved.",
      "missingness": "Two employees are not certified as independent authors, and funding alone does not fill trial-drug provision or external-analysis roles. Parent I0 is also preserved.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Two employees are not certified as independent authors, and funding alone does not fill trial-drug provision or external-analysis roles. Parent I0 is also preserved."
    },
    {
      "item_id": "N20",
      "question_type": "Comparative efficacy",
      "question": "Were one trial, two periods, recurrent events and two tables kept from independent addition?",
      "needed": "Bibliography, trial, same people, periods and sibling-question relationships",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Bibliography, trial, same people, periods and sibling-question relationships",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Link added reports to original registration, the same population, outcomes and period relationships.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "One Wysham2017 SWITCH2 report and the same crossover population share two existing questions.",
      "condition_status": "Partly verified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Periods, treatment contributions, recurrent events and overall/severe components are not added as new trials/participants. Final independent counts and participant totals are null.",
      "missingness": "Periods, treatment contributions, recurrent events and overall/severe components are not added as new trials/participants. Final independent counts and participant totals are null.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Periods, treatment contributions, recurrent events and overall/severe components are not added as new trials/participants. Final independent counts and participant totals are null."
    },
    {
      "item_id": "N21",
      "question_type": "Comparative efficacy",
      "question": "Do gaps remain for nocturnal, other-period, baseline-risk-subgroup and individual effects?",
      "needed": "Original prespecified subgroups, timepoints, outcomes, interactions and denominators",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Original prespecified subgroups, timepoints, outcomes, interactions and denominators",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Acquire original period/subgroup plans, outcomes, denominators, interactions and multiplicity.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Core values in the designated existing summary concern overall symptomatic and severe outcomes during 16-week maintenance.",
      "condition_status": "Unverified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. No nocturnal, titration, full-period, baseline-risk-specific effect, individual suitability or drug choice is invented.",
      "missingness": "No nocturnal, titration, full-period, baseline-risk-specific effect, individual suitability or drug choice is invented.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "No nocturnal, titration, full-period, baseline-risk-specific effect, individual suitability or drug choice is invented."
    },
    {
      "item_id": "N22",
      "question_type": "Supplementary harm evidence",
      "question": "Are hypoglycemia outcomes separated from other drug harms and safety denominators?",
      "needed": "Harm definitions, people/events, actual exposure, denominators and relatedness",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Harm definitions, people/events, actual exposure, denominators and relatedness",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Acquire original other harms, group people/events, safety denominators, exposure and relatedness.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The existing summary records patient-experienced hypoglycemia as a treatment harm. Both treatments are insulins and parent safety is caution.",
      "condition_status": "Partly verified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Reduced overall hypoglycemia is not extended to absence of other harms or overall drug safety. Other-harm tables, relatedness and safety populations remain unread.",
      "missingness": "Reduced overall hypoglycemia is not extended to absence of other harms or overall drug safety. Other-harm tables, relatedness and safety populations remain unread.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Reduced overall hypoglycemia is not extended to absence of other harms or overall drug safety. Other-harm tables, relatedness and safety populations remain unread."
    },
    {
      "item_id": "N23",
      "question_type": "Supplementary harm evidence",
      "question": "What are the gaps in rare/long-term harms, discontinuation, actual exposure and treatment application?",
      "needed": "Original harm collection, exposure, discontinuation, follow-up, periods and independent relationships",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Original harm collection, exposure, discontinuation, follow-up, periods and independent relationships",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Acquire original exposure, harm-related discontinuation, collection, rare/long-term outcomes and direct material for new populations/drugs.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Original completion/contribution limitations and the severe-proportion CI are preserved; long-term/rare-harm tables were not provided.",
      "condition_status": "Unverified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. No dose-adjustment, monitoring, injection, treatment choice/substitution, coverage or cost guidance is created. Nonreporting/nonsignificance is not used as long-term safety or zero rare events.",
      "missingness": "No dose-adjustment, monitoring, injection, treatment choice/substitution, coverage or cost guidance is created. Nonreporting/nonsignificance is not used as long-term safety or zero rare events.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "No dose-adjustment, monitoring, injection, treatment choice/substitution, coverage or cost guidance is created. Nonreporting/nonsignificance is not used as long-term safety or zero rare events."
    },
    {
      "item_id": "N24",
      "question_type": "Comparative efficacy",
      "question": "Are stored summaries, bibliographic URLs, registration identifiers and external access distinguished?",
      "needed": "Original bibliography, URLs, identifiers and access to abstracts/full texts/registration/plans",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Original bibliography, URLs, identifiers and access to abstracts/full texts/registration/plans",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Link user-provided individual source material to its type and access status.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The complete stored parent-verdict summary was read for production; Wysham2017 PubMed PMID28672317, registration identifier NCT02030600 and the original source URL were linked.",
      "condition_status": "Partly verified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. External abstracts, full texts, registration, protocols and SAPs remain unread. No new URL/DOI is constructed from identifiers and no separate link test was run.",
      "missingness": "External abstracts, full texts, registration, protocols and SAPs remain unread. No new URL/DOI is constructed from identifiers and no separate link test was run.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "External abstracts, full texts, registration, protocols and SAPs remain unread. No new URL/DOI is constructed from identifiers and no separate link test was run."
    },
    {
      "item_id": "N25",
      "question_type": "Comparative efficacy",
      "question": "Are Korean/English, axes, the reference date, corrections, empty values, candidate history and current production preserved?",
      "needed": "Distinguishing the selected verdict record, complete parent, original languages, history and current production",
      "role": "Supplementary",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Distinguishing the selected verdict record, complete parent, original languages, history and current production",
      "basis": "Selected claim: Reduced severe hypoglycemia",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Only user-added material/decisions are linked as separate events after preserving the complete original.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "2026-08-26, empty correction/deliberation values, parent C50, safety caution, axes, Korean/English articles, selected subclaim C/D and notes are preserved in their original form.",
      "condition_status": "Partly verified",
      "status_reason": "Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Original design/missingness and prescription/cost explanations are historical, not current review, lookup or recommendations. Absent subclaim values are not filled; candidate review-pending/production-eligible indicators are historical.",
      "missingness": "Original design/missingness and prescription/cost explanations are historical, not current review, lookup or recommendations. Absent subclaim values are not filled; candidate review-pending/production-eligible indicators are historical.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original design/missingness and prescription/cost explanations are historical, not current review, lookup or recommendations. Absent subclaim values are not filled; candidate review-pending/production-eligible indicators are historical."
    }
  ],
  "reports": [
    {
      "report_id": "R01",
      "title": "Wysham C, Bhargava A, Chaykin L, et al. Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 2 Diabetes. JAMA. 2017;318(1):45-56. PMID: 28672317.",
      "url": "https://pubmed.ncbi.nlm.nih.gov/28672317/",
      "report_type": "Randomized crossover superiority-trial report",
      "existence": "Material preserved in the original citation/evidence lists",
      "acquired_read": "Summary read; external materials not read",
      "study_family": "F01",
      "independent_replication": false,
      "observed_result": "185.6 versus 265.4 events/100 patient-years; rate ratio 0.70 (0.61–0.80), absolute difference -23.66 events/100 patient-years; patient-proportion difference -9.1%p",
      "result_level": "Stored review summary; not a result of comparing the original external report here",
      "materials": [
        {
          "material_type": "Stored existing review summary",
          "public_status": "Original URL preserved",
          "access_status": "Summary read",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-08-26",
          "qualification": "Stored parent-verdict summary"
        },
        {
          "material_type": "External abstract",
          "public_status": "Original URL preserved",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; a URL does not mean acquisition, reading or completed review"
        },
        {
          "material_type": "External full paper",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; a URL does not mean acquisition, reading or completed review"
        },
        {
          "material_type": "External registration",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; a URL does not mean acquisition, reading or completed review"
        },
        {
          "material_type": "External protocol and SAP",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; a URL does not mean acquisition, reading or completed review"
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/28672317/"
        }
      ]
    }
  ],
  "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": "Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing"
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing"
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing"
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing"
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing"
    }
  ],
  "status_dictionary": {
    "Partly verified": "Some information is in the stored summary; detailed original material remains unverified. This does not certify passed review or clinical efficacy",
    "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety",
    "Review incomplete": "Awaiting user review",
    "Met": "Use only within the relevant condition's scope after user review; no automatic display in this preparation",
    "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings",
    "Inaccessible": "Not applied during this preparation because actual access was not tested",
    "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary",
    "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation",
    "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials"
  },
  "study_overlap": {
    "state": "Unverified",
    "unique_trial_count": null,
    "unique_participant_count": null,
    "reason": "Family IDs link relationships and do not certify unique trial counts; added reports, sibling questions, the same participants and outcomes are not added independently. F01: the same SWITCH2 crossover report, patients, two periods, recurrent events and overall/severe hypoglycemia are shared by both subquestions"
  },
  "history": [
    {
      "date": "2026-10-10",
      "kind": "Separation of public-facing pages and materials",
      "view_version": "1.0",
      "change": "The public page and data were prepared from the existing 25 items. No new clinical search, verification-status change or scoring was performed."
    }
  ],
  "language": "en",
  "translation_date": "2026-10-10"
}