{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2961-s0", "verdict_number": "2961", "title": "High-volume energy drinks · Original findings did not support the no-QTc/blood-pressure-problem claim", "view_version": "1.0", "view_created_date": "2026-10-12", "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 whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "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": "2019 biomarker trial: 34 healthy adults aged 18–40 without cardiovascular disease, hypertension, QT prolongation or regular medication use. Direct clinical-event populations/denominators are unverified.", "intervention": "Single intake within one hour of 946 mL of energy drink containing about 300–320 mg caffeine", "dose": "Original research exposure: 946 mL, about 300–320 mg caffeine, one exposure within one hour. Actual composition/intake completion and long-term exposure are unverified; this is not dosing guidance.", "comparator": "2019 within-person crossover of commercial drinks A/B versus placebo. Placebo composition/caffeine, effective n by condition and model details are unverified. The 2017 energy-drink-versus-caffeine comparison is a separate qualitative bibliography.", "endpoint": "Maximum Bazett-QTc changes: A +17.9±13.9 ms, B +19.6±15.8 ms, placebo +11.9±11.1 ms; overall P=.005, A versus placebo P=.04, B versus placebo P<.01. QTc and peripheral/central SBP/DBP-by-time interactions were all P<.001. Actual between-condition effects/CIs and quantitative blood-pressure results are unverified.", "duration": "2019 measurements every 30 minutes through 240 minutes after intake. Crossover visits/washout and actual clinical-event/long-term-risk observation are unverified.", "excluded_extensions": [ "Transferring QTc/blood-pressure biomarker changes to occurrence of clinical arrhythmia, hospitalization or death", "Converting/calculating condition-specific QTc maxima into between-group differences or ± into CIs", "Creating new blood-pressure quantities, clusters/conditions/denominators or zero clinical events", "Interpreting the 10-ms power assumption as a clinical-arrhythmia threshold/effect", "Copying 2019 n/effects/NCT/support disclosures to 2017/Mayo", "Certifying author overlap as an identical cohort or earlier/blood-pressure descriptions as independent clinical-event replication", "Summing participants/trials across two checklists, reports, conditions or time points", "Creating long-term/small-dose/adolescent/disease-medication population benefits/harms or intake/prevention/treatment procedures" ] }, "requirements": [ { "item_id": "N01", "question_type": "Biomarkers · No-effect claim · Harms", "question": "What is the original direction of the selected existing question?", "needed": "Exact subclaim wording, Korean/English text and question/record relationship", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Exact subclaim wording, Korean/English text and question/record relationship.", "application_exception": "Do not count trials, participants or clinical events twice because two existing checklists were prepared.", "criterion": "Connect Exact subclaim wording, Korean/English text and question/record relationship to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If the question changes, retain the original existing wording, previous complete version and change event separately.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The selected question is “No QTc or blood-pressure effect” in the existing subclaim, distinguished from its verdict record. The original no-problem claim wording is retained, separately from the original context that harm signals did not support it.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. No new independent-claim certification, invented verdict or subclaim subdivision was made.", "missingness": "No new independent-claim certification, invented verdict or subclaim subdivision was made.", "uncertainty": "Preparation scope of the stored summary. No new independent-claim certification, invented verdict or subclaim subdivision was made.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Selected existing verdict record and complete parent summary" }, { "item_id": "N02", "question_type": "Biomarkers · No-effect claim · Harms", "question": "How do the subclaim verdict and parent score/axes differ?", "needed": "Actual subclaim grade/note, absent score/status/axes and parent D30", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Actual subclaim grade/note, absent score/status/axes and parent D30.", "application_exception": "Do not inherit parent D30 or historical cross-checks as a subclaim score, current content-review pass or new independence certification.", "criterion": "Connect Actual subclaim grade/note, absent score/status/axes and parent D30 to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "When evidence is updated, distinguish original value preservation from actual judgment events.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The subclaim is D, with the note “QTc and blood-pressure trajectories differed from placebo.” It has no score/status/axes fields. Parent D30, Caution and B/S/R1/I2/E-/B2/C0 are parent context.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Subclaim score/status/assessment axes are null; parent values are not inserted.", "missingness": "Subclaim score/status/assessment axes are null; parent values are not inserted.", "uncertainty": "Preparation scope of the stored summary. Subclaim score/status/assessment axes are null; parent values are not inserted.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original subclaim record and parent grade/score/axes and assessment history" }, { "item_id": "N03", "question_type": "Biomarkers · No-effect claim · Harms", "question": "What are the actual trial population and applicability boundaries?", "needed": "Healthy adults aged 18–40, baseline exclusions and selected population", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Healthy adults aged 18–40, baseline exclusions and selected population.", "application_exception": "Do not extend the healthy young population to adolescents, patients, regular medication users or all consumers.", "criterion": "Connect Healthy adults aged 18–40, baseline exclusions and selected population to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M03 §3.2.1; detailed population conditions are Chamgap's own design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Distinguish other population materials by baseline risk, medication, age and actual eligibility.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The 2019 trial involved 34 healthy adults aged 18–40 without cardiovascular disease, hypertension, QT prolongation or regular medication use.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Detailed recruitment, sex, baseline QTc/blood pressure, caffeine habits, inclusion/exclusion and actual outcome population n are unverified.", "missingness": "Detailed recruitment, sex, baseline QTc/blood pressure, caffeine habits, inclusion/exclusion and actual outcome population n are unverified.", "uncertainty": "Preparation scope of the stored summary. Detailed recruitment, sex, baseline QTc/blood pressure, caffeine habits, inclusion/exclusion and actual outcome population n are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Recruitment/baseline characteristics, eligibility and outcome-specific flow" }, { "item_id": "N04", "question_type": "Biomarkers · No-effect claim · Harms", "question": "What are the actual identity and duration of the research exposure?", "needed": "946 mL, about 300–320 mg caffeine and one exposure within one hour", "role": "Required", "role_reason": "Preparation condition retaining the original scope of 946 mL, about 300–320 mg caffeine and one exposure within one hour.", "application_exception": "Do not calculate or create can counts, caffeine equivalents, safe limits or intake/manufacturing/dosing guidance.", "criterion": "Connect 946 mL, about 300–320 mg caffeine and one exposure within one hour to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Connect nominal/actual and product-specific exposure differences with the relevant outcome.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original exposure was a single intake of 946 mL of energy drink containing about 300–320 mg caffeine within one hour.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Actual individual intake/completion, full composition, batches, other exposure and adherence are unverified.", "missingness": "Actual individual intake/completion, full composition, batches, other exposure and adherence are unverified.", "uncertainty": "Preparation scope of the stored summary. Actual individual intake/completion, full composition, batches, other exposure and adherence are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Product composition, actual exposure, intake completion and crossover records" }, { "item_id": "N05", "question_type": "Biomarkers · No-effect claim · Harms", "question": "What are the identity and composition differences of drinks A/B and placebo?", "needed": "Commercial products A/B, preparation in identical containers and placebo composition", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Commercial products A/B, preparation in identical containers and placebo composition.", "application_exception": "Do not use the 2017 caffeine-comparison title to verify that the 2019 placebo was caffeine-matched.", "criterion": "Connect Commercial products A/B, preparation in identical containers and placebo composition to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If actual product materials are provided, distinguish caffeine, combined ingredients and placebo differences.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The stored review summary records investigators preparing commercial drinks in identical containers and participants consuming A, B and placebo separately.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Brands, quantities of A/B ingredients, placebo caffeine/calories/sugar, matching taste/appearance and separate effects of non-caffeine ingredients are unverified.", "missingness": "Brands, quantities of A/B ingredients, placebo caffeine/calories/sugar, matching taste/appearance and separate effects of non-caffeine ingredients are unverified.", "uncertainty": "Preparation scope of the stored summary. Brands, quantities of A/B ingredients, placebo caffeine/calories/sugar, matching taste/appearance and separate effects of non-caffeine ingredients are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial product/placebo composition, preparation and distinguishability" }, { "item_id": "N06", "question_type": "Biomarkers · No-effect claim · Harms", "question": "How do 240-minute measurements differ from long-term observation?", "needed": "Measurements through 240 minutes, 30-minute intervals and acute time points", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Measurements through 240 minutes, 30-minute intervals and acute time points.", "application_exception": "Do not convert four hours into sufficient clinical-event testing duration or long-term safety.", "criterion": "Connect Measurements through 240 minutes, 30-minute intervals and acute time points to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP; Design-specific harm questions in M19 §19.2; Detailed temporal relationships are internally designed", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Distinguish actual observation durations of acute biomarkers and long-term clinical outcomes in follow-up materials.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The 2019 trial measured QTc and blood pressure every 30 minutes through 240 minutes after a single exposure.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Intervals/washout between crossover visits, complete actual follow-up, subsequent event collection and repeated/long-term intake are unverified.", "missingness": "Intervals/washout between crossover visits, complete actual follow-up, subsequent event collection and repeated/long-term intake are unverified.", "uncertainty": "Preparation scope of the stored summary. Intervals/washout between crossover visits, complete actual follow-up, subsequent event collection and repeated/long-term intake are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Visit/washout schedule, outcome collection and event follow-up scope" }, { "item_id": "N07", "question_type": "Biomarkers · No-effect claim · Harms", "question": "What are the sequence and analysis units of the crossover trial?", "needed": "A/B/placebo in the same 34 people, sequence allocation and carryover/period effects", "role": "Required", "role_reason": "Preparation condition retaining the original scope of A/B/placebo in the same 34 people, sequence allocation and carryover/period effects.", "application_exception": "Do not sum A/B/placebo, repeated time points or two checklists as independent participants/trials.", "criterion": "Connect A/B/placebo in the same 34 people, sequence allocation and carryover/period effects to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M08 §8.1–8.2.3; CHAMGAP adaptation; Distinction between studies and reports in M04 §4.6.1–4.6.2; Cohort/outcome connections are CHAMGAP adaptations", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "When materials are supplemented, distinguish conditions/time points within the same person and crossover assumptions.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The recorded design is a randomized double-masked placebo-controlled crossover trial; the same participants underwent each drink condition.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Sequence-specific n, sequence generation/concealment, washout, carryover, period/sequence models and effective n by condition are unverified.", "missingness": "Sequence-specific n, sequence generation/concealment, washout, carryover, period/sequence models and effective n by condition are unverified.", "uncertainty": "Preparation scope of the stored summary. Sequence-specific n, sequence generation/concealment, washout, carryover, period/sequence models and effective n by condition are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Crossover flow, sequence/period and original analysis model" }, { "item_id": "N08", "question_type": "Biomarkers · No-effect claim · Harms", "question": "What are the common conditions and other exposures?", "needed": "Pre-visit caffeine/activity, meals, medication and measurement environment", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Pre-visit caffeine/activity, meals, medication and measurement environment.", "application_exception": "Do not invent fasting/rest/restriction times or experimental/daily-life procedures absent from the stored review summary.", "criterion": "Connect Pre-visit caffeine/activity, meals, medication and measurement environment to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Record actual common product-comparison conditions and other exposures together in follow-up materials.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The stored review summary preserves a healthy population and acute comparison of three drinks.", "condition_status": "Unverified", "status_reason": "Required direct definitions, values and materials are unverified within the current stored-summary/unread-external-material scope. Pre-visit caffeine/meal/activity restrictions, measurement environment, concurrent exposure and actual condition implementation are unverified.", "missingness": "Pre-visit caffeine/meal/activity restrictions, measurement environment, concurrent exposure and actual condition implementation are unverified.", "uncertainty": "Preparation scope of the stored summary. Pre-visit caffeine/meal/activity restrictions, measurement environment, concurrent exposure and actual condition implementation are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Pre-visit conditions, concurrent exposure and actual implementation/measurement records" }, { "item_id": "N09", "question_type": "Biomarkers · No-effect claim · Harms", "question": "How were double masking, measurement and interpretation implemented?", "needed": "Roles masked, identical containers and ECG/blood-pressure collection", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Roles masked, identical containers and ECG/blood-pressure collection.", "application_exception": "Do not newly verify masking of all interpretations or absence of measurement errors solely from identical containers or a design label.", "criterion": "Connect Roles masked, identical containers and ECG/blood-pressure collection to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Connect actual masking by role and measurement processes to outcomes.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original design is described as double-masked, with investigators preparing drinks in identical containers.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Masking/unmasking of participants, staff, ECG readers and analysts, test techniques, equipment and interpretation details are unverified.", "missingness": "Masking/unmasking of participants, staff, ECG readers and analysts, test techniques, equipment and interpretation details are unverified.", "uncertainty": "Preparation scope of the stored summary. Masking/unmasking of participants, staff, ECG readers and analysts, test techniques, equipment and interpretation details are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Masking, measurement/interpretation methods and original collection materials" }, { "item_id": "N10", "question_type": "Biomarkers · No-effect claim · Harms", "question": "What are the registration identifier and current registration-content status?", "needed": "2019 NCT03196908 and registration history/plans", "role": "Required", "role_reason": "Preparation condition retaining the original scope of 2019 NCT03196908 and registration history/plans.", "application_exception": "Do not copy the 2019 NCT as the 2017 registration identifier or upgrade identifier presence to registration verification/link checks.", "criterion": "Connect 2019 NCT03196908 and registration history/plans to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/result links are a Chamgap application; M08 Table 8.2.a and M04 §4.6.3; Chamgap application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If registration materials are provided, distinguish the report, plans and actual reading scope.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "NCT03196908 appears in the first existing evidence record and research description. The 2017 citation has no separate registration identifier.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Registration dates, changes, original plans and current content/results disclosure are unread; the 2017 registration identity is unverified.", "missingness": "Registration dates, changes, original plans and current content/results disclosure are unread; the 2017 registration identity is unverified.", "uncertainty": "Preparation scope of the stored summary. Registration dates, changes, original plans and current content/results disclosure are unread; the 2017 registration identity is unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original 2019 registration/plans and separate 2017 registration/method materials" }, { "item_id": "N11", "question_type": "Biomarkers · No-effect claim · Harms", "question": "What are the bibliographies and source locations of the two reports?", "needed": "Shah 2019, Fletcher 2017, PMIDs and evidence/citations", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Shah 2019, Fletcher 2017, PMIDs and evidence/citations.", "application_exception": "Do not create an evidence group absent from the stored summary for R02 or infer DOI/PMCID from article numbers.", "criterion": "Connect Shah 2019, Fletcher 2017, PMIDs and evidence/citations to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "When bibliography is supplemented, distinguish report identity, original results and change events.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "R01 is Shah SA et al., 2019, J Am Heart Assoc 8:e011318, PMID 31137991. R02 is Fletcher EA et al., 2017, the same journal 6:e004448, PMID 28446495. There is one evidence group and two citations.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. DOIs, PMCIDs, 2017 recruitment/result values and current external bibliography are absent from the stored review summary and were not looked up.", "missingness": "DOIs, PMCIDs, 2017 recruitment/result values and current external bibliography are absent from the stored review summary and were not looked up.", "uncertainty": "Preparation scope of the stored summary. DOIs, PMCIDs, 2017 recruitment/result values and current external bibliography are absent from the stored review summary and were not looked up.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original bibliography, full text and registration/population connections for each report" }, { "item_id": "N12", "question_type": "Biomarkers · No-effect claim · Harms", "question": "What is the scope of investigator overlap and Mayo blood-pressure replication?", "needed": "Identical/unknown cohorts, author overlap and independent QTc/BP distinction", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Identical/unknown cohorts, author overlap and independent QTc/BP distinction.", "application_exception": "Do not equate investigator overlap with an identical cohort or create R03/independent clinical-arrhythmia evidence from unspecified Mayo mentions.", "criterion": "Connect Identical/unknown cohorts, author overlap and independent QTc/BP distinction to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Distinguish identical cohorts, investigator overlap, independent institutions and QTc/blood-pressure endpoint replication in new materials.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The stored review summary states that 2017 involved overlapping investigators and was not independent replication; independent Mayo investigators replicated blood pressure only. Limited independent QTc replication is a historical description.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Actual participant overlap/trial relationships between 2017 and 2019 and Mayo bibliography/populations/values are unverified.", "missingness": "Actual participant overlap/trial relationships between 2017 and 2019 and Mayo bibliography/populations/values are unverified.", "uncertainty": "Preparation scope of the stored summary. Actual participant overlap/trial relationships between 2017 and 2019 and Mayo bibliography/populations/values are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Authors/institutions, registration, participant families and actual Mayo reports" }, { "item_id": "N13", "question_type": "Biomarkers · No-effect claim · Harms", "question": "What is the original scope of support and disclosed relationships?", "needed": "2019 university support, unreported company funding and litigation expert-witness history", "role": "Required", "role_reason": "Preparation condition retaining the original scope of 2019 university support, unreported company funding and litigation expert-witness history.", "application_exception": "Do not upgrade university support or unreported company funding to new independence certification, absence of conflicts or identical 2017 support.", "criterion": "Connect 2019 university support, unreported company funding and litigation expert-witness history to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If disclosures are provided, distinguish reports, support types, external relationships and historical/current scope.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original record states University of the Pacific support, no reported energy-drink-company funding and Sachin A. Shah’s expert-witness history in caffeine energy-drink litigation.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Product purchase/provision, analysis/publication support, current contracts/relationships and individual 2017 funding/COI disclosures are unread.", "missingness": "Product purchase/provision, analysis/publication support, current contracts/relationships and individual 2017 funding/COI disclosures are unread.", "uncertainty": "Preparation scope of the stored summary. Product purchase/provision, analysis/publication support, current contracts/relationships and individual 2017 funding/COI disclosures are unread.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original support, product provision, author disclosures and analysis/publication roles for each report" }, { "item_id": "N14", "question_type": "Biomarkers · No-effect claim · Harms", "question": "How are original dates, Korean/English text, corrections, axes and history retained?", "needed": "2026-08-26, empty corrections/deliberation and parent/sibling context", "role": "Required", "role_reason": "Preparation condition retaining the original scope of 2026-08-26, empty corrections/deliberation and parent/sibling context.", "application_exception": "Do not fill original grades, absences, empty values or historical cross-checks with new values/current completed review.", "criterion": "Connect 2026-08-26, empty corrections/deliberation and parent/sibling context to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If changed materials arise, distinguish the complete pre-change original, events, versions and separate application.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The reference date is 2026-08-26, corrections are an empty array and deliberation an empty string. Complete stored review text preserves Korean/English content, synthesized summaries, verdict decisions, assessment axes and false flags.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Separate classification information and the primary-failed/secondary-positive indicator are absent from this stored review summary. Empty corrections are not a current external correction/retraction check.", "missingness": "Separate classification information and the primary-failed/secondary-positive indicator are absent from this stored review summary. Empty corrections are not a current external correction/retraction check.", "uncertainty": "Preparation scope of the stored summary. Separate classification information and the primary-failed/secondary-positive indicator are absent from this stored review summary. Empty corrections are not a current external correction/retraction check.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete original stored review summary and actual correction/change events" }, { "item_id": "N15", "question_type": "Biomarkers · No-effect claim · Harms", "question": "Which materials were actually read?", "needed": "Complete local JSON summary, report-specific material items and unread external originals", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Complete local JSON summary, report-specific material items and unread external originals.", "application_exception": "Do not convert original citation links, historical paper descriptions or copies into external full-text reading/successful access.", "criterion": "Connect Complete local JSON summary, report-specific material items and unread external originals to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Distinguish public availability, access, acquisition, actual reading scope and dates for new materials.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The complete preserved 2961 JSON and its two existing selections were read for preparation. Reading of each report’s summary is distinguished from unread external originals in each checklist.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. External abstracts, full texts, registrations, plans, results/harms and disclosures have not been accessed or acquired; no link checks were performed.", "missingness": "External abstracts, full texts, registrations, plans, results/harms and disclosures have not been accessed or acquired; no link checks were performed.", "uncertainty": "Preparation scope of the stored summary. External abstracts, full texts, registrations, plans, results/harms and disclosures have not been accessed or acquired; no link checks were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "User-provided original materials and actual acquisition/reading records" }, { "item_id": "N16", "question_type": "Biomarkers · No-effect claim · Harms", "question": "Are two checklists/material items distinguished from trials/participants?", "needed": "s0/s1, two reports, conditions/time points and null unique trial/participant totals", "role": "Required", "role_reason": "Preparation condition retaining the original scope of s0/s1, two reports, conditions/time points and null unique trial/participant totals.", "application_exception": "Do not add two checklists/reports/crossover conditions or 34-person values to create an independent total sample.", "criterion": "Connect s0/s1, two reports, conditions/time points and null unique trial/participant totals to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/result links are a Chamgap application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptation is Chamgap’s own design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Connect additional reports by distinguishing identical/different populations, institutions and endpoints.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The two existing questions have different scopes in the same complete stored summary. Connecting R01’s 34 people, A/B/placebo and time-point materials to both checklists creates no new participant or replication trial.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Unique trial count, participant total, actual inter-report cohort overlap and independence are not newly summed or certified.", "missingness": "Unique trial count, participant total, actual inter-report cohort overlap and independence are not newly summed or certified.", "uncertainty": "Preparation scope of the stored summary. Unique trial count, participant total, actual inter-report cohort overlap and independence are not newly summed or certified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-report-participant-condition-time-point-question relationships" }, { "item_id": "N17", "question_type": "Biomarkers · No-effect claim · Harms", "question": "What is connected when new materials become available?", "needed": "Conditions, originals, observations, corrections, reading and change events", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Conditions, originals, observations, corrections, reading and change events.", "application_exception": "Original candidate pending/eligibility indications are historical; do not reactivate them as active review/waiting.", "criterion": "Connect Conditions, originals, observations, corrections, reading and change events to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Separate actual additions/changes into complete prior originals, events, condition versions/freezing, separate application and current handoff.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The two existing questions are prepared separately in the same seven-column format. Each condition was saved/frozen first, with a separate application timestamp retained.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. No new clinical search, calculation, effect/CI, reassessment, independence certification or model/internal content review was performed.", "missingness": "No new clinical search, calculation, effect/CI, reassessment, independence certification or model/internal content review was performed.", "uncertainty": "Preparation scope of the stored summary. No new clinical search, calculation, effect/CI, reassessment, independence certification or model/internal content review was performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "User-provided direct endpoint/denominator/plan, clinical event, correction and harm materials" }, { "item_id": "N18", "question_type": "Biomarkers · No-effect claim · Harms", "question": "What are the QTc correction methods and actual endpoints?", "needed": "Bazett/Fridericia, maximum change and QTc definition", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Bazett/Fridericia, maximum change and QTc definition.", "application_exception": "Do not transfer Bazett values to Fridericia or clinical-arrhythmia outcomes.", "criterion": "Connect Bazett/Fridericia, maximum change and QTc definition to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If materials are provided, connect correction methods, original values/changes, time points and maxima separately.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The existing evidence endpoint is Bazett- and Fridericia-corrected QTc; the numeric table concerns maximum Bazett-QTc change. QTc is an ECG marker of delayed ventricular repolarization.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Correction formulas, original QT/RR, equipment/interpretation, Fridericia values and actual maximum derivation are unverified.", "missingness": "Correction formulas, original QT/RR, equipment/interpretation, Fridericia values and actual maximum derivation are unverified.", "uncertainty": "Preparation scope of the stored summary. Correction formulas, original QT/RR, equipment/interpretation, Fridericia values and actual maximum derivation are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original ECG results/measurement and maximum derivation by correction method" }, { "item_id": "N19", "question_type": "Biomarkers · No-effect claim · Harms", "question": "How are original maximum Bazett-QTc values retained?", "needed": "A +17.9±13.9 ms, B +19.6±15.8 ms and placebo +11.9±11.1 ms", "role": "Required", "role_reason": "Preparation condition retaining the original scope of A +17.9±13.9 ms, B +19.6±15.8 ms and placebo +11.9±11.1 ms.", "application_exception": "Do not call these original values between-group differences or subtract placebo values to calculate new effects/CIs.", "criterion": "Connect A +17.9±13.9 ms, B +19.6±15.8 ms and placebo +11.9±11.1 ms to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Connect condition-specific values and actual statistical definitions in new tables.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "Maximum Bazett-QTc changes are A +17.9±13.9 ms, B +19.6±15.8 ms and placebo +11.9±11.1 ms. Each is recorded as a maximum change from baseline.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. The statistical definition of ±, condition-specific n, maximum time points, baseline values and original change variance tables are unverified.", "missingness": "The statistical definition of ±, condition-specific n, maximum time points, baseline values and original change variance tables are unverified.", "uncertainty": "Preparation scope of the stored summary. The statistical definition of ±, condition-specific n, maximum time points, baseline values and original change variance tables are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Condition-specific maxima/time points, baseline, variance and denominator result tables" }, { "item_id": "N20", "question_type": "Biomarkers · No-effect claim · Harms", "question": "What are the actual comparisons in overall and pairwise tests?", "needed": "Overall P=.005, A versus placebo P=.04 and B versus placebo P<.01", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Overall P=.005, A versus placebo P=.04 and B versus placebo P<.01.", "application_exception": "Do not convert pairwise P values into a direct A/B superiority or clinical-risk ranking.", "criterion": "Connect Overall P=.005, A versus placebo P=.04 and B versus placebo P<.01 to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M08 §8.2.2, M15 §15.3.1; CHAMGAP adaptation; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Connect overall, pairwise and adjusted tests with the relevant outcomes in analysis materials.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original reader answer records overall P=.005, A versus placebo P=.04 and B versus placebo P<.01; both drinks had larger maximum QTc changes than placebo.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Test models, multiplicity corrections, estimated between-condition differences and paired analysis details are unverified.", "missingness": "Test models, multiplicity corrections, estimated between-condition differences and paired analysis details are unverified.", "uncertainty": "Preparation scope of the stored summary. Test models, multiplicity corrections, estimated between-condition differences and paired analysis details are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original tests/contrasts, multiplicity and between-condition estimates" }, { "item_id": "N21", "question_type": "Biomarkers · No-effect claim · Harms", "question": "How do QTc-by-time results differ from maximum-change tests?", "needed": "Time interaction P<.001 and overall maximum P=.005", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Time interaction P<.001 and overall maximum P=.005.", "application_exception": "Do not convert time-interaction P values into effects at particular time points, individual conditions or clinical events.", "criterion": "Connect Time interaction P<.001 and overall maximum P=.005 to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 §8.2.2, M15 §15.3.1; our own application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "When materials are supplemented, distinguish time interactions from contrasts of a single summary value.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "QTc-by-time interaction P<.001 and overall maximum Bazett-QTc test P=.005 are separate results in the original stored review summary.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Correction-specific time models, between-condition effects/intervals at each time point and measurement denominators are unverified.", "missingness": "Correction-specific time models, between-condition effects/intervals at each time point and measurement denominators are unverified.", "uncertainty": "Preparation scope of the stored summary. Correction-specific time models, between-condition effects/intervals at each time point and measurement denominators are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Time models, QTc by time point, maxima and result tables" }, { "item_id": "N22", "question_type": "Biomarkers · No-effect claim · Harms", "question": "Which sites and pressure types do blood-pressure results concern?", "needed": "Peripheral/central, systolic/diastolic and time interactions", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Peripheral/central, systolic/diastolic and time interactions.", "application_exception": "Do not create new values/conclusions for blood-pressure magnitude, hypertension diagnosis, sustained increases or clinical events.", "criterion": "Connect Peripheral/central, systolic/diastolic and time interactions to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Distinguish sites, pressure types, time points and within-/between-condition results in new blood-pressure materials.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original research description states that peripheral and central systolic- and diastolic-pressure-by-time interactions were all P<.001.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Absolute values, changes, between-group differences, mmHg intervals and visit-specific measurement/denominators for each pressure are absent from the stored review summary.", "missingness": "Absolute values, changes, between-group differences, mmHg intervals and visit-specific measurement/denominators for each pressure are absent from the stored review summary.", "uncertainty": "Preparation scope of the stored summary. Absolute values, changes, between-group differences, mmHg intervals and visit-specific measurement/denominators for each pressure are absent from the stored review summary.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original pressure values, changes, time points, equipment/conditions and result tables" }, { "item_id": "N23", "question_type": "Biomarkers · No-effect claim · Harms", "question": "What is the scope of unreported between-condition 95% CIs?", "needed": "Between-condition intervals, ± notation, P values and original non-reporting record", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Between-condition intervals, ± notation, P values and original non-reporting record.", "application_exception": "Do not convert ± into CIs or calculate between-condition CIs/effects from P values or sample size.", "criterion": "Connect Between-condition intervals, ± notation, P values and original non-reporting record to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M15 §15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Connect provided intervals with actual correction methods, measures and denominators.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "Original research text and synthesized summaries record that the paper did not present between-condition 95% CIs. External originals/supplementary tables were not read this time.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Actual intervals/non-reporting across current external materials and effect denominators are unverified.", "missingness": "Actual intervals/non-reporting across current external materials and effect denominators are unverified.", "uncertainty": "Preparation scope of the stored summary. Actual intervals/non-reporting across current external materials and effect denominators are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original between-condition estimates/CIs, denominators and supplements" }, { "item_id": "N24", "question_type": "Biomarkers · No-effect claim · Harms", "question": "What kind of threshold is 10 ms?", "needed": "Power assumption of a 10-ms QTc mean difference and clinical interpretation boundary", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Power assumption of a 10-ms QTc mean difference and clinical interpretation boundary.", "application_exception": "Do not newly confirm a between-condition threshold or arrhythmia risk because each condition’s maximum change exceeds 10 ms.", "criterion": "Connect Power assumption of a 10-ms QTc mean difference and clinical interpretation boundary to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M15 §§15.3.1–15.3.3; Chamgap adaptation", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If materials are provided, connect sample-size assumptions and validated clinical thresholds separately.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "Sample size assumed detection of a 10-ms QTc mean difference. The stored review summary states that without a CI for a between-condition difference exceeding 10 ms, this was not used to exclude a clinical threshold.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Validated clinical importance, the relevant between-condition interval and prespecified criterion details are unverified.", "missingness": "Validated clinical importance, the relevant between-condition interval and prespecified criterion details are unverified.", "uncertainty": "Preparation scope of the stored summary. Validated clinical importance, the relevant between-condition interval and prespecified criterion details are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original power, clinical importance and between-condition estimate materials" }, { "item_id": "N25", "question_type": "Biomarkers · No-effect claim · Harms", "question": "What are the 34-person sample, actual outcome analysis and missingness?", "needed": "34 study participants, effective n by condition/time, completion and ITT/paired analysis", "role": "Required", "role_reason": "Preparation condition retaining the original scope of 34 study participants, effective n by condition/time, completion and ITT/paired analysis.", "application_exception": "Do not copy 34 as a verified analysis denominator at each time point or multiply it by observations.", "criterion": "Connect 34 study participants, effective n by condition/time, completion and ITT/paired analysis to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If original tables are provided, distinguish person, condition, time-point and outcome denominators.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The stored review summary’s n is 34 healthy adults. Details are insufficient to establish 34 effective measurements/analyses in every crossover condition/time point.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Allocation/exposure/condition completion, effective ECG/blood-pressure n, missingness reasons/handling and analysis populations/models are unverified.", "missingness": "Allocation/exposure/condition completion, effective ECG/blood-pressure n, missingness reasons/handling and analysis populations/models are unverified.", "uncertainty": "Preparation scope of the stored summary. Allocation/exposure/condition completion, effective ECG/blood-pressure n, missingness reasons/handling and analysis populations/models are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Crossover/outcome-specific flow, denominators and missingness/analysis records" }, { "item_id": "N26", "question_type": "Biomarkers · No-effect claim · Harms", "question": "What are the prespecified primary QTc and blood-pressure hierarchy?", "needed": "Prespecified QTc, correction/maxima/time analyses and blood-pressure hierarchy", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Prespecified QTc, correction/maxima/time analyses and blood-pressure hierarchy.", "application_exception": "Do not upgrade parent assessment axes or historical stored descriptions to current plan-review certification.", "criterion": "Connect Prespecified QTc, correction/maxima/time analyses and blood-pressure hierarchy to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If plans are provided, connect actual prespecified/post hoc distinctions, endpoint hierarchy and selected analyses.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The stored review summary records worsening of prespecified primary QTc. Blood-pressure time interactions are also recorded, but separate hierarchy/plan details are absent.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Original registration/SAP QTc definitions, correction methods, maximum/time analyses, primary/secondary blood pressure and multiple testing are unverified.", "missingness": "Original registration/SAP QTc definitions, correction methods, maximum/time analyses, primary/secondary blood pressure and multiple testing are unverified.", "uncertainty": "Preparation scope of the stored summary. Original registration/SAP QTc definitions, correction methods, maximum/time analyses, primary/secondary blood pressure and multiple testing are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified protocols/SAPs, registration histories and endpoint/analysis hierarchy" }, { "item_id": "N27", "question_type": "Biomarkers · No-effect claim · Harms", "question": "How are the no-problem claim and original observed direction distinguished?", "needed": "No-effect claim, QTc/blood-pressure changes and original D/note", "role": "Required", "role_reason": "Preparation condition retaining the original scope of No-effect claim, QTc/blood-pressure changes and original D/note.", "application_exception": "Do not reverse the original claim into confirmed increased clinical arrhythmia or make a new assessment.", "criterion": "Connect No-effect claim, QTc/blood-pressure changes and original D/note to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; Status distinctions are designed by CHAMGAP; Question clarification principles in M03 §3.1 and §3.2.1–3.2.4; Detailed separation rules are internally designed", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Connect original claim, observed direction and verdict context as recorded; distinguish separate actual clinical outcomes.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The exact question is “No QTc or blood-pressure effect.” The stored review summary records that QTc/blood-pressure trajectory differences from placebo did not support the claim.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Clinical importance of measured differences and applicability to persistence/long-term/all exposures are unverified.", "missingness": "Clinical importance of measured differences and applicability to persistence/long-term/all exposures are unverified.", "uncertainty": "Preparation scope of the stored summary. Clinical importance of measured differences and applicability to persistence/long-term/all exposures are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original selected-claim wording and direct endpoint/clinical importance materials" }, { "item_id": "N28", "question_type": "Biomarkers · No-effect claim · Harms", "question": "What is the boundary between surrogate markers and clinical events?", "needed": "QTc/blood-pressure surrogate signals and direct arrhythmia/hospitalization/death outcomes", "role": "Required", "role_reason": "Preparation condition retaining the original scope of QTc/blood-pressure surrogate signals and direct arrhythmia/hospitalization/death outcomes.", "application_exception": "Do not transfer QTc prolongation/blood-pressure differences to occurrence effects for clinical arrhythmia, hospitalization or death.", "criterion": "Connect QTc/blood-pressure surrogate signals and direct arrhythmia/hospitalization/death outcomes to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M03 §3.2.4; internally defined extension boundary; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to report clinical-event materials with definitions, verification, risk periods and denominators separate from biomarkers.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The stored review summary explicitly states that this is a four-hour biomarker trial that did not test arrhythmia, hospitalization or death. The sibling s1 grade is ?.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Direct clinical event definitions, event counts, denominators, durations and effect intervals are unverified in these materials.", "missingness": "Direct clinical event definitions, event counts, denominators, durations and effect intervals are unverified in these materials.", "uncertainty": "Preparation scope of the stored summary. Direct clinical event definitions, event counts, denominators, durations and effect intervals are unverified in these materials.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct clinical-event follow-up/comparisons and diagnostic/occurrence materials" }, { "item_id": "N29", "question_type": "Biomarkers · No-effect claim · Harms", "question": "Is this extended to other doses, chronic use or populations?", "needed": "Healthy adults aged 18–40, a single high-volume exposure and direct evidence for other conditions", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Healthy adults aged 18–40, a single high-volume exposure and direct evidence for other conditions.", "application_exception": "Do not create small-dose safety, chronic harms, general-population intake limits or dosing/care guidance.", "criterion": "Connect Healthy adults aged 18–40, a single high-volume exposure and direct evidence for other conditions to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If direct materials are provided, distinguish exposure/population/duration differences for the relevant question.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The stored review summary states that results cannot be extended to chronic intake, one can or less, adolescents, cardiovascular patients or medication users.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Direct QTc/blood-pressure/clinical-event materials for other products/doses, repeated exposure and at-risk populations are unverified.", "missingness": "Direct QTc/blood-pressure/clinical-event materials for other products/doses, repeated exposure and at-risk populations are unverified.", "uncertainty": "Preparation scope of the stored summary. Direct QTc/blood-pressure/clinical-event materials for other products/doses, repeated exposure and at-risk populations are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct outcomes for each actual exposure, population and duration" }, { "item_id": "N30", "question_type": "Biomarkers · No-effect claim · Harms", "question": "What is the scope of the earlier 2017 report and Mayo blood-pressure context?", "needed": "Overlapping-investigator QTc direction and independent blood-pressure-only description", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Overlapping-investigator QTc direction and independent blood-pressure-only description.", "application_exception": "Do not copy 2019 values, n or NCT to 2017/Mayo or convert the description into independent clinical-event replication.", "criterion": "Connect Overlapping-investigator QTc direction and independent blood-pressure-only description to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; Status distinctions are designed by CHAMGAP; M04 §4.6.1–4.6.2, M15 §15.3.1; CHAMGAP adaptation", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Distinguish institution/population relationships and actual replicated endpoints in additional report materials.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "Fletcher 2017 has a bibliography for an energy-drink-versus-caffeine ECG/hemodynamic trial and a summary of QTc prolongation direction. Independent Mayo blood-pressure descriptions are historical context without a bibliography.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Actual 2017 effects/CIs/sample, Mayo bibliography/conditions/values and direct independent QTc verification are unverified.", "missingness": "Actual 2017 effects/CIs/sample, Mayo bibliography/conditions/values and direct independent QTc verification are unverified.", "uncertainty": "Preparation scope of the stored summary. Actual 2017 effects/CIs/sample, Mayo bibliography/conditions/values and direct independent QTc verification are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual original outcomes and population/institution/registration connections for each report" }, { "item_id": "H01", "question_type": "Biomarkers · No-effect claim · Harms", "question": "Are biomarkers, harms and clinical-event collection distinguished?", "needed": "QTc/BP testing, verified clinical events and adverse-event definitions", "role": "Supporting harm information", "role_reason": "Preparation condition retaining the original scope of QTc/BP testing, verified clinical events and adverse-event definitions.", "application_exception": "Do not convert biomarker worsening into clinical-event counts or untested outcomes into zero adverse events.", "criterion": "Connect QTc/BP testing, verified clinical events and adverse-event definitions to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish measured biomarkers, symptoms and verified events in follow-up materials.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "Original materials record QTc/BP time changes and no testing of arrhythmia/hospitalization/death. The original context is that biomarker differences did not support the selected no-problem claim.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Complete adverse/serious event lists, collection/relatedness assessment and verified clinical-event lists are unverified.", "missingness": "Complete adverse/serious event lists, collection/relatedness assessment and verified clinical-event lists are unverified.", "uncertainty": "Preparation scope of the stored summary. Complete adverse/serious event lists, collection/relatedness assessment and verified clinical-event lists are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Collection plans, harm definitions and direct clinical outcome tables" }, { "item_id": "H02", "question_type": "Biomarkers · No-effect claim · Harms", "question": "What are harm timing and actual exposure?", "needed": "Single research exposure, acute measurement and event-risk periods", "role": "Supporting harm information", "role_reason": "Preparation condition retaining the original scope of Single research exposure, acute measurement and event-risk periods.", "application_exception": "Do not convert the original exposure into recommended intake, a safe dose or prevention/treatment methods.", "criterion": "Connect Single research exposure, acute measurement and event-risk periods to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M19 §19.2 design-specific harm questions; timing details are Chamgap-designed", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish exposure, testing times and clinical-event risk periods in harm materials.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "Research exposure was 946 mL with about 300–320 mg caffeine within one hour; measurements covered 240 minutes.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Actual completed exposure, individual response times, post-follow-up events and long-term risk periods are unverified.", "missingness": "Actual completed exposure, individual response times, post-follow-up events and long-term risk periods are unverified.", "uncertainty": "Preparation scope of the stored summary. Actual completed exposure, individual response times, post-follow-up events and long-term risk periods are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual exposure, response times and event follow-up/risk windows" }, { "item_id": "H03", "question_type": "Biomarkers · No-effect claim · Harms", "question": "How do between-condition biomarker differences differ from clinical harm comparisons?", "needed": "Biomarker outcomes for A/B/placebo and clinical-event comparisons", "role": "Supporting harm information", "role_reason": "Preparation condition retaining the original scope of Biomarker outcomes for A/B/placebo and clinical-event comparisons.", "application_exception": "Do not transfer biomarker P values to clinical-harm P values or between-condition event risks.", "criterion": "Connect Biomarker outcomes for A/B/placebo and clinical-event comparisons to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M19 §§19.2.2–19.2.4 and M03 §3.2.3; Chamgap adaptation", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to connect direct harm materials using event definitions, comparisons and intervals separate from biomarkers.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The stored review summary records maximum QTc and blood-pressure time differences, while direct clinical arrhythmia/hospitalization/death comparisons were not tested.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Clinical-event contrasts, original numerators/denominators, durations and intervals are unverified.", "missingness": "Clinical-event contrasts, original numerators/denominators, durations and intervals are unverified.", "uncertainty": "Preparation scope of the stored summary. Clinical-event contrasts, original numerators/denominators, durations and intervals are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual clinical-event comparators, counts and estimates" }, { "item_id": "H04", "question_type": "Biomarkers · No-effect claim · Harms", "question": "What are safety and event denominators?", "needed": "34 people and actual denominators by condition/time/event", "role": "Supporting harm information", "role_reason": "Preparation condition retaining the original scope of 34 people and actual denominators by condition/time/event.", "application_exception": "Do not multiply crossover conditions/time measurements into participant counts or calculate risk rates from unread materials.", "criterion": "Connect 34 people and actual denominators by condition/time/event to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M19 §§19.1.2–19.2.4; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish person, condition, time-point and measurement/event denominators in originals.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The 34 people in the stored review summary are healthy adult crossover-trial participants; separate denominators for each event/safety analysis were not provided.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Condition-specific exposure, measurement, event collection, serious-harm denominators and repeated-observation aggregation are unverified.", "missingness": "Condition-specific exposure, measurement, event collection, serious-harm denominators and repeated-observation aggregation are unverified.", "uncertainty": "Preparation scope of the stored summary. Condition-specific exposure, measurement, event collection, serious-harm denominators and repeated-observation aggregation are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Safety/event denominators, condition-specific flow and original counts" }, { "item_id": "H05", "question_type": "Biomarkers · No-effect claim · Harms", "question": "What are alternative harm factors and ingredient-specific attribution?", "needed": "Caffeine, combined ingredients, baseline/concurrent exposures and relatedness", "role": "Supporting harm information", "role_reason": "Preparation condition retaining the original scope of Caffeine, combined ingredients, baseline/concurrent exposures and relatedness.", "application_exception": "Do not attribute every signal to caffeine alone or established harm from a particular ingredient, or invent mechanisms/event cases.", "criterion": "Connect Caffeine, combined ingredients, baseline/concurrent exposures and relatedness to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M19 §§19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap-designed", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish whole products, ingredient-specific attribution and alternative factors in direct harm materials.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "Exposure was commercial energy drink with about 300–320 mg caffeine. The stored review summary preserves a whole-product comparison.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Non-caffeine ingredients, composition, other exposures, baseline susceptibility and alternative causes/relatedness assessment for individual events are unverified.", "missingness": "Non-caffeine ingredients, composition, other exposures, baseline susceptibility and alternative causes/relatedness assessment for individual events are unverified.", "uncertainty": "Preparation scope of the stored summary. Non-caffeine ingredients, composition, other exposures, baseline susceptibility and alternative causes/relatedness assessment for individual events are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original ingredients, concurrent exposures, baseline risk and harm-case assessment" }, { "item_id": "H06", "question_type": "Biomarkers · No-effect claim · Harms", "question": "Are unread, untested, unreported and zero events distinguished?", "needed": "Actual reading level, untested clinical endpoints and original reports", "role": "Supporting harm information", "role_reason": "Preparation condition retaining the original scope of Actual reading level, untested clinical endpoints and original reports.", "application_exception": "Do not convert currently unread materials into zero side effects, failed access, an absent paper or confirmed direct clinical harm.", "criterion": "Connect Actual reading level, untested clinical endpoints and original reports to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M19 §§19.1.2–19.2.4 and M04 §4.6.3; Chamgap adaptation", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Only for provided materials, connect actual zero events, missingness, non-reporting and non-collection with locations/durations.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "Actual reading this time concerns preserved JSON summaries; the original description of untested clinical events is retained.", "condition_status": "Unverified", "status_reason": "Required direct definitions, values and materials are unverified within the current stored-summary/unread-external-material scope. Distinctions among collection, non-reporting, undetermined findings and actual zero events in external originals, and all harm outcomes, are unverified.", "missingness": "Distinctions among collection, non-reporting, undetermined findings and actual zero events in external originals, and all harm outcomes, are unverified.", "uncertainty": "Preparation scope of the stored summary. Distinctions among collection, non-reporting, undetermined findings and actual zero events in external originals, and all harm outcomes, are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original collection plans, complete results, missingness reasons and reading records" }, { "item_id": "H07", "question_type": "Biomarkers · No-effect claim · Harms", "question": "Are harms across reports, conditions and two checklists protected from duplicate counting?", "needed": "2017/2019, author overlap, conditions/time points and two questions in the same summary", "role": "Supporting harm information", "role_reason": "Preparation condition retaining the original scope of 2017/2019, author overlap, conditions/time points and two questions in the same summary.", "application_exception": "Do not equate investigator overlap with the same cohort or count two bibliographies/checklists as new independent-event replication.", "criterion": "Connect 2017/2019, author overlap, conditions/time points and two questions in the same summary to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish repeated reports of the same event from different populations/new events in harm materials.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "Two checklists prepare different existing questions from the same stored 2961 summary. The 2017/2019 bibliographies involve overlapping investigators; actual participant overlap is unverified.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Actual relationships of identical events/people across reports, independent harm families and repeated events by condition are unverified.", "missingness": "Actual relationships of identical events/people across reports, independent harm families and repeated events by condition are unverified.", "uncertainty": "Preparation scope of the stored summary. Actual relationships of identical events/people across reports, independent harm families and repeated events by condition are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-person-condition-time-point-event-question relationships" }, { "item_id": "H08", "question_type": "Biomarkers · No-effect claim · Harms", "question": "What are safety gaps for long-term use and vulnerable populations?", "needed": "Selected healthy adults, single high-volume exposure and chronic use/patients/adolescents", "role": "Supporting harm information", "role_reason": "Preparation condition retaining the original scope of Selected healthy adults, single high-volume exposure and chronic use/patients/adolescents.", "application_exception": "Do not create safe-dose, intake/care, arrhythmia prevention/treatment or medical-replacement procedures.", "criterion": "Connect Selected healthy adults, single high-volume exposure and chronic use/patients/adolescents to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M19 §§19.1.2–19.2.4; Chamgap adaptation", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to record direct materials together with actual exposure, population and observation duration.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The parent emphasizes a single high-volume exposure in healthy young adults; the original safety status is Caution.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. Direct harm/clinical-event materials for chronic/repeated intake, other doses, adolescents, disease/medication and mixed exposures are unverified within this scope.", "missingness": "Direct harm/clinical-event materials for chronic/repeated intake, other doses, adolescents, disease/medication and mixed exposures are unverified within this scope.", "uncertainty": "Preparation scope of the stored summary. Direct harm/clinical-event materials for chronic/repeated intake, other doses, adolescents, disease/medication and mixed exposures are unverified within this scope.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct harms and clinical follow-up by exposure/duration/risk population" }, { "item_id": "H09", "question_type": "Biomarkers · No-effect claim · Harms", "question": "Are signals distinguished from direct causal or clinical confirmation?", "needed": "Biomarker signals, original D, direct clinical ? and unverified information", "role": "Supporting harm information", "role_reason": "Preparation condition retaining the original scope of Biomarker signals, original D, direct clinical ? and unverified information.", "application_exception": "Do not label original question wording as proven observation or combine biomarkers and clinical events into a new harm assessment.", "criterion": "Connect Biomarker signals, original D, direct clinical ? and unverified information to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "Chamgap interpretive boundary informed by M19 principles; no formal causality tool was run", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish observation, relatedness, direct clinical-effect levels and change events in additional materials.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "Original s0 is D for the no-QTc/BP-effect claim; s1 is ? for increased clinical arrhythmia. Biomarker signals and the gap in direct clinical events are retained separately.", "condition_status": "Partly verified", "status_reason": "Information from the stored summary is connected; this does not mean new clinical verification, fulfilled conditions or completed content review. No new benefit/harm assessment, occurrence effect, causal/independence certification or treatment selection was created.", "missingness": "No new benefit/harm assessment, occurrence effect, causal/independence certification or treatment selection was created.", "uncertainty": "Preparation scope of the stored summary. No new benefit/harm assessment, occurrence effect, causal/independence certification or treatment selection was created.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual biomarker/clinical-event materials, denominators, intervals and verification" } ], "reports": [ { "report_id": "R01", "title": "Shah SA, et al. Impact of High Volume Energy Drink Consumption on Electrocardiographic and Blood Pressure Parameters: A Randomized Trial. J Am Heart Assoc. 2019;8:e011318. PMID: 31137991.", "url": "https://pubmed.ncbi.nlm.nih.gov/31137991/", "report_type": "2019 energy-drink A/B versus placebo biomarker crossover trial", "existence": "Bibliography and URL preserved from the summary’s citation list", "acquired_read": "Summary read; external materials not read", "study_family": "Shah 2019 · NCT03196908 crossover population", "independent_replication": false, "observed_result": "Maximum Bazett-QTc changes: A +17.9±13.9 ms, B +19.6±15.8 ms, placebo +11.9±11.1 ms; overall P=.005; blood-pressure time interactions are separate. The original boundary states that direct clinical arrhythmia, hospitalization and death were not tested.", "result_level": "First existing evidence record / Parent QTc and blood-pressure biomarker outcomes", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Locally preserved summary", "access_status": "Local copy acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T16:33:13.833927+09:00", "qualification": "The relevant bibliography, results and scope in the complete stored summary were read for preparation; this is not external full-text reading." }, { "material_type": "External abstract", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the citation URL in the review summary is connected; no current abstract/access verification was made." }, { "material_type": "External full text", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the existing bibliographic link is connected; current full-text location, public availability and access are unverified." }, { "material_type": "Registration", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original NCT03196908 identity; content/history are currently unread." }, { "material_type": "Protocol", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Required material item; file existence/public availability, definitions, hierarchy and dates are unverified." }, { "material_type": "Statistical analysis plan", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Required material item for crossover/conditions/time/missingness, contrasts and clinical collection scope." }, { "material_type": "Results, denominator and harm details", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Required material item for biomarkers, effective n by condition, intervals and direct clinical-endpoint collection; unread materials are not changed to zero events." }, { "material_type": "Support and interests", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Report-specific support/roles/current relationships are unread; 2019 support descriptions are not copied as individual 2017 disclosures." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/31137991/" } ] }, { "report_id": "R02", "title": "Fletcher EA, et al. Randomized Controlled Trial of High-Volume Energy Drink Versus Caffeine Consumption on ECG and Hemodynamic Parameters. J Am Heart Assoc. 2017;6:e004448. PMID: 28446495.", "url": "https://pubmed.ncbi.nlm.nih.gov/28446495/", "report_type": "Earlier 2017 energy-drink-versus-caffeine report with overlapping investigators", "existence": "Bibliography and URL preserved from the summary’s citation list", "acquired_read": "Summary read; external materials not read", "study_family": "Fletcher 2017 earlier trial · Actual relationship to 2019 participants is unverified", "independent_replication": false, "observed_result": "The earlier 2017 trial with overlapping investigators has only energy-drink-versus-caffeine bibliography and a summary of QTc prolongation direction. Sample, values, registration and clinical-event collection are unverified.", "result_level": "Second report in the existing citations · Qualitative context of the parent counterview", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Locally preserved summary", "access_status": "Local copy acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T16:33:13.833927+09:00", "qualification": "The relevant bibliography, results and scope in the complete stored summary were read for preparation; this is not external full-text reading." }, { "material_type": "External abstract", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the citation URL in the review summary is connected; no current abstract/access verification was made." }, { "material_type": "External full text", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the existing bibliographic link is connected; current full-text location, public availability and access are unverified." }, { "material_type": "Registration", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "2017 registration identifier is absent from the review summary; the 2019 identifier is not copied." }, { "material_type": "Protocol", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Required material item; file existence/public availability, definitions, hierarchy and dates are unverified." }, { "material_type": "Statistical analysis plan", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Required material item for crossover/conditions/time/missingness, contrasts and clinical collection scope." }, { "material_type": "Results, denominator and harm details", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Required material item for biomarkers, effective n by condition, intervals and direct clinical-endpoint collection; unread materials are not changed to zero events." }, { "material_type": "Support and interests", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Report-specific support/roles/current relationships are unread; 2019 support descriptions are not copied as individual 2017 disclosures." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/28446495/" } ] } ], "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." } ], "status_dictionary": { "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.", "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.", "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.", "Review incomplete": "Review of existing content or actual review incomplete.", "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.", "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.", "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.", "Not applicable": "Used when the reason it does not apply to the original question is stated.", "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Shah 2019 pivotal direct biomarker trial and Fletcher 2017 earlier report with overlapping investigators. Actual participant/registration relationships are unverified; an identical cohort is not established. Mayo blood-pressure replication is qualitative stored-summary context without a bibliography; no R03 is created. Two checklists/conditions/time points are not summed." }, "history": [ { "date": "2026-10-12", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public reader pages and materials were prepared from the existing 39 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-12" }