{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2961-s1", "verdict_number": "2961", "title": "High-volume energy drinks · Gap in direct evidence for increased clinical arrhythmia", "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": "The selected question concerns directly increased clinical arrhythmia. Original grade ?, and no testing in the four-hour trial. Event definitions, verification, numerators/denominators, effects/intervals and direct follow-up 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": "Clinical harms · Materials", "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 existing question is “Increased clinical arrhythmia,” distinguished from its subclaim verdict record. The original wording of the question about increased clinical events is 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 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": "Clinical harms · Materials", "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 ?, with the note “The four-hour trial did not test clinical arrhythmia.” 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": "Clinical harms · Materials", "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": "Clinical harms · Materials", "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": "Clinical harms · Materials", "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": "Clinical harms · Materials", "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": "Clinical harms · Materials", "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": "Clinical harms · Materials", "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": "Clinical harms · Materials", "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": "Clinical harms · Materials", "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": "Clinical harms · Materials", "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": "Clinical harms · Materials", "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": "Clinical harms · Materials", "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": "Clinical harms · Materials", "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": "Clinical harms · Materials", "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": "Clinical harms · Materials", "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": "Clinical harms · Materials", "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": "Clinical harms · Materials", "question": "What is the direct definition of clinical arrhythmia?", "needed": "Actual clinical-arrhythmia types, diagnosis/verification and symptoms/assessment", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Actual clinical-arrhythmia types, diagnosis/verification and symptoms/assessment.", "application_exception": "Do not convert QTc prolongation, blood-pressure signals or assumed palpitations into actual arrhythmia diagnoses.", "criterion": "Connect Actual clinical-arrhythmia types, diagnosis/verification and symptoms/assessment 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; 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 specify event types, verification levels, occurrence times and original populations in clinical-event 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 selected question is “Increased clinical arrhythmia”; the stored review note explicitly states that the four-hour trial did not test clinical arrhythmia.", "condition_status": "Unverified", "status_reason": "Required direct definitions, values and materials are unverified within the current stored-summary/unread-external-material scope. Arrhythmia types, symptom/ECG verification, assessment criteria, baseline arrhythmia exclusions and occurrence definitions are unverified.", "missingness": "Arrhythmia types, symptom/ECG verification, assessment criteria, baseline arrhythmia exclusions and occurrence definitions are unverified.", "uncertainty": "Preparation scope of the stored summary. Arrhythmia types, symptom/ECG verification, assessment criteria, baseline arrhythmia exclusions and occurrence definitions are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct clinical-event definitions, verification/adjudication and diagnostic materials" }, { "item_id": "N19", "question_type": "Clinical harms · Materials", "question": "Does the QTc biomarker answer increased event occurrence?", "needed": "Separation of delayed-repolarization biomarkers and direct clinical events", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Separation of delayed-repolarization biomarkers and direct clinical events.", "application_exception": "Do not convert biomarker P values/means/the 10-ms assumption into clinical-arrhythmia effects or event counts.", "criterion": "Connect Separation of delayed-repolarization biomarkers and direct clinical events 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 distinguish biomarkers, symptoms and verified events in actual clinical 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": "QTc is an ECG marker of delayed ventricular repolarization. The parent states that QTc prolongation cannot immediately be called clinical-arrhythmia occurrence.", "condition_status": "Unverified", "status_reason": "Required direct definitions, values and materials are unverified within the current stored-summary/unread-external-material scope. Connections/validation between biomarker changes and direct arrhythmia occurrence, and occurrence data by population/duration, are unverified.", "missingness": "Connections/validation between biomarker changes and direct arrhythmia occurrence, and occurrence data by population/duration, are unverified.", "uncertainty": "Preparation scope of the stored summary. Connections/validation between biomarker changes and direct arrhythmia occurrence, and occurrence data by population/duration, are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct event follow-up, diagnoses and outcomes separate from exposures/biomarkers" }, { "item_id": "N20", "question_type": "Clinical harms · Materials", "question": "Are arrhythmia event counts and at-risk population denominators available?", "needed": "Clinical-event numerators, exposure/comparator denominators, baseline disease and recurrent events", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Clinical-event numerators, exposure/comparator denominators, baseline disease and recurrent events.", "application_exception": "Do not convert untested outcomes into zero events or copy 34 as a verified arrhythmia denominator.", "criterion": "Connect Clinical-event numerators, exposure/comparator denominators, baseline disease and recurrent events to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are designed by CHAMGAP; 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 distinguish person counts, recurrent events, exposure conditions and risk periods in clinical 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 records that arrhythmia, hospitalization and death were not tested. The 34 people are participants in the biomarker crossover trial.", "condition_status": "Unverified", "status_reason": "Required direct definitions, values and materials are unverified within the current stored-summary/unread-external-material scope. Clinical-arrhythmia numerators, actual at-risk/condition-specific denominators, recurrent/first occurrences and person-time are unverified.", "missingness": "Clinical-arrhythmia numerators, actual at-risk/condition-specific denominators, recurrent/first occurrences and person-time are unverified.", "uncertainty": "Preparation scope of the stored summary. Clinical-arrhythmia numerators, actual at-risk/condition-specific denominators, recurrent/first occurrences and person-time are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct event counts, at-risk/exposure denominators and person/event relationships" }, { "item_id": "N21", "question_type": "Clinical harms · Materials", "question": "How do four-hour measurements differ from clinical-risk periods?", "needed": "240 minutes of acute biomarker measurements, actual event follow-up and long-term exposure", "role": "Required", "role_reason": "Preparation condition retaining the original scope of 240 minutes of acute biomarker measurements, actual event follow-up and long-term exposure.", "application_exception": "Do not convert four-hour test markers into completed clinical-event testing or absence of long-term events.", "criterion": "Connect 240 minutes of acute biomarker measurements, actual event follow-up and long-term exposure to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "Design-specific harm questions in M19 §19.2; Detailed temporal relationships are internally designed; 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": "Retain a proposal to distinguish measurement times from actual event observation/verification periods.", "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": "2019 measurements occurred every 30 minutes through 240 minutes after intake. The study is not recorded as sufficiently capturing subsequent clinical events.", "condition_status": "Unverified", "status_reason": "Required direct definitions, values and materials are unverified within the current stored-summary/unread-external-material scope. Continuous event monitoring, emergency/hospitalization follow-up, post-exposure risk windows and long-term follow-up are unverified.", "missingness": "Continuous event monitoring, emergency/hospitalization follow-up, post-exposure risk windows and long-term follow-up are unverified.", "uncertainty": "Preparation scope of the stored summary. Continuous event monitoring, emergency/hospitalization follow-up, post-exposure risk windows and long-term follow-up are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Clinical verification, timing/risk windows and long-term follow-up materials" }, { "item_id": "N22", "question_type": "Clinical harms · Materials", "question": "What are the actual contrasts and adjustments for clinical events?", "needed": "Verified energy-drink-versus-comparator arrhythmia effects and models", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Verified energy-drink-versus-comparator arrhythmia effects and models.", "application_exception": "Do not transfer biomarker A/B pairwise P values or caffeine content to between-condition clinical-event effects.", "criterion": "Connect Verified energy-drink-versus-comparator arrhythmia effects and models to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M19 §19.2.2–19.2.4, M03 §3.2.3; CHAMGAP adaptation; M08 §8.2.2, M15 §15.3.1; CHAMGAP adaptation", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to connect actual exposure, comparator populations, baseline risk and models with events in clinical 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 A/B/placebo comparisons concern QTc and blood pressure. Actual estimates comparing increased clinical arrhythmia are not provided in the stored review summary.", "condition_status": "Unverified", "status_reason": "Required direct definitions, values and materials are unverified within the current stored-summary/unread-external-material scope. Clinical-event contrasts, baseline risk, caffeine/concurrent-exposure adjustment and crossover/observational-design models are unverified.", "missingness": "Clinical-event contrasts, baseline risk, caffeine/concurrent-exposure adjustment and crossover/observational-design models are unverified.", "uncertainty": "Preparation scope of the stored summary. Clinical-event contrasts, baseline risk, caffeine/concurrent-exposure adjustment and crossover/observational-design models are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct clinical comparisons, numerators/denominators and confounding/analysis definitions" }, { "item_id": "N23", "question_type": "Clinical harms · Materials", "question": "Are arrhythmia effects, CIs and power provided?", "needed": "Direct clinical-event effects, intervals, denominators and power", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Direct clinical-event effects, intervals, denominators and power.", "application_exception": "Do not calculate arrhythmia effects/CIs/risk rates from the QTc 10-ms assumption, ±, P values or n.", "criterion": "Connect Direct clinical-event effects, intervals, denominators and power 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": "If direct clinical estimates are provided, connect measures, denominators, durations and uncertainty.", "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": "Unreported 95% CIs and the 10-ms assumption in the stored review summary concern between-condition QTc comparisons. Clinical-arrhythmia effects/CIs were not provided.", "condition_status": "Unverified", "status_reason": "Required direct definitions, values and materials are unverified within the current stored-summary/unread-external-material scope. Direct arrhythmia risk differences/RRs/HRs, CIs, power and minimum important differences are unverified.", "missingness": "Direct arrhythmia risk differences/RRs/HRs, CIs, power and minimum important differences are unverified.", "uncertainty": "Preparation scope of the stored summary. Direct arrhythmia risk differences/RRs/HRs, CIs, power and minimum important differences are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Clinical occurrence effects, intervals, actual denominators and plans" }, { "item_id": "N24", "question_type": "Clinical harms · Materials", "question": "What are the prespecified and actual clinical-arrhythmia collection plans?", "needed": "Event plans, diagnosis, surveillance and primary/supportive/exploratory hierarchy", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Event plans, diagnosis, surveillance and primary/supportive/exploratory hierarchy.", "application_exception": "Do not inherit primary QTc or an NCT identifier as prespecified/actually tested clinical arrhythmia.", "criterion": "Connect Event plans, diagnosis, surveillance and primary/supportive/exploratory 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": "Retain a proposal to distinguish prespecified plans from actual collection and the scope of events tested in new 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 prespecified primary endpoint was QTc; the stored review summary explicitly states that clinical arrhythmia was not tested.", "condition_status": "Unverified", "status_reason": "Required direct definitions, values and materials are unverified within the current stored-summary/unread-external-material scope. Prespecified arrhythmia endpoints, active/passive collection, surveillance plans, plan dates and actual implementation are unverified.", "missingness": "Prespecified arrhythmia endpoints, active/passive collection, surveillance plans, plan dates and actual implementation are unverified.", "uncertainty": "Preparation scope of the stored summary. Prespecified arrhythmia endpoints, active/passive collection, surveillance plans, plan dates and actual implementation are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original plans, clinical-event collection/assessment and outcome hierarchy" }, { "item_id": "N25", "question_type": "Clinical harms · Materials", "question": "How do event missingness, non-collection and non-reporting differ?", "needed": "Actual clinical-event collection, observation loss and reporting level", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Actual clinical-event collection, observation loss and reporting level.", "application_exception": "Do not convert currently unread/untested materials into failed access, zero arrhythmias or confirmed increased arrhythmia.", "criterion": "Connect Actual clinical-event collection, observation loss and reporting level to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish actual non-occurrence of events from absent collection/follow-up in clinical 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": "Only the preserved description of untested arrhythmia in a biomarker trial was read this time. External original materials/supplementary tables are unread.", "condition_status": "Unverified", "status_reason": "Required direct definitions, values and materials are unverified within the current stored-summary/unread-external-material scope. Distinctions among absent event collection, non-reporting, undetermined findings, observation loss and zero events, and direct materials, are unverified.", "missingness": "Distinctions among absent event collection, non-reporting, undetermined findings, observation loss and zero events, and direct materials, are unverified.", "uncertainty": "Preparation scope of the stored summary. Distinctions among absent event collection, non-reporting, undetermined findings, observation loss and zero events, and direct materials, are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Clinical collection methods, follow-up flow, omissions/missingness and original tables" }, { "item_id": "N26", "question_type": "Clinical harms · Materials", "question": "Are hospitalization, death and symptoms separate outcomes?", "needed": "Distinction among arrhythmia, palpitations/symptoms, hospitalization and death", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Distinction among arrhythmia, palpitations/symptoms, hospitalization and death.", "application_exception": "Do not assume symptoms to create new events or sum event types into a composite occurrence rate.", "criterion": "Connect Distinction among arrhythmia, palpitations/symptoms, hospitalization and death 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; CHAMGAP’s interpretation boundary, informed by M19 principles; no official 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 record symptoms, diagnoses, healthcare use and death as separate event 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 stored review summary states that arrhythmia, hospitalization and death were not directly tested. Symptom-occurrence values were not provided either.", "condition_status": "Unverified", "status_reason": "Required direct definitions, values and materials are unverified within the current stored-summary/unread-external-material scope. Definitions, denominators and durations for symptoms, verified arrhythmia, emergency care/hospitalization and death are unverified.", "missingness": "Definitions, denominators and durations for symptoms, verified arrhythmia, emergency care/hospitalization and death are unverified.", "uncertainty": "Preparation scope of the stored summary. Definitions, denominators and durations for symptoms, verified arrhythmia, emergency care/hospitalization and death are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct verification, numerators/denominators and risk periods for each clinical outcome" }, { "item_id": "N27", "question_type": "Clinical harms · Materials", "question": "What are applicability gaps for patients, adolescents and long-term exposure?", "needed": "Healthy young people, one high-volume exposure and other risks/durations", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Healthy young people, one high-volume exposure and other risks/durations.", "application_exception": "Do not newly establish/create clinical harms/safety, prevention/treatment or intake-care guidance for populations outside the trial.", "criterion": "Connect Healthy young people, one high-volume exposure and other risks/durations 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 Chamgap’s own design; 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": "Retain a proposal to distinguish actual risk populations, exposures, durations, concurrent medication and events in clinical 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 2019 population comprised healthy adults aged 18–40, excluding disease, hypertension, QT prolongation and regular medication use.", "condition_status": "Unverified", "status_reason": "Required direct definitions, values and materials are unverified within the current stored-summary/unread-external-material scope. Direct arrhythmia materials for baseline arrhythmia/cardiovascular risk, adolescents, medication/mixed exposure, small doses and repeated/chronic intake are unverified.", "missingness": "Direct arrhythmia materials for baseline arrhythmia/cardiovascular risk, adolescents, medication/mixed exposure, small doses and repeated/chronic intake are unverified.", "uncertainty": "Preparation scope of the stored summary. Direct arrhythmia materials for baseline arrhythmia/cardiovascular risk, adolescents, medication/mixed exposure, small doses and repeated/chronic intake are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct clinical occurrence materials by exposure/risk population/duration" }, { "item_id": "N28", "question_type": "Clinical harms · Materials", "question": "Are earlier QTc and independent blood-pressure descriptions direct arrhythmia replication?", "needed": "Separation of 2017 biomarkers, Mayo blood pressure and direct clinical-event materials", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Separation of 2017 biomarkers, Mayo blood pressure and direct clinical-event materials.", "application_exception": "Do not transfer earlier overlapping-investigator or independent blood-pressure descriptions into independently established increased clinical arrhythmia.", "criterion": "Connect Separation of 2017 biomarkers, Mayo blood pressure and direct clinical-event materials to actual endpoints, exposures, comparisons, time, denominators and reading levels; distinguish unverified information.", "basis": "M04 §4.6.1–4.6.2, M15 §15.3.1; 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": "Retain a proposal to distinguish biomarker replication, institutional independence and direct clinical-event replication in additional 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": "2017 is an earlier bibliography with QTc prolongation direction; Mayo is a description of independent blood-pressure replication. The stored review summary has no independent replication results for direct arrhythmia occurrence.", "condition_status": "Unverified", "status_reason": "Required direct definitions, values and materials are unverified within the current stored-summary/unread-external-material scope. Actual clinical-event collection, bibliography, samples and verification materials from earlier/separate trials, and independent direct arrhythmia research, are unverified.", "missingness": "Actual clinical-event collection, bibliography, samples and verification materials from earlier/separate trials, and independent direct arrhythmia research, are unverified.", "uncertainty": "Preparation scope of the stored summary. Actual clinical-event collection, bibliography, samples and verification materials from earlier/separate trials, and independent direct arrhythmia research, are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Clinical outcomes and population/institution/registration connections in each actual report" }, { "item_id": "N29", "question_type": "Clinical harms · Materials", "question": "What is the scope of the original ? grade and untested-outcome note?", "needed": "Selected clinical-event question, original ? and gap in direct evidence", "role": "Required", "role_reason": "Preparation condition retaining the original scope of Selected clinical-event question, original ? and gap in direct evidence.", "application_exception": "Do not copy parent D in place of the selected ? or display the question “Increased clinical arrhythmia” as a confirmed observed conclusion.", "criterion": "Connect Selected clinical-event question, original ? and gap in direct evidence 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 internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If new direct materials are provided, preserve original ? and originals/change events while distinguishing separate judgment and preparation.", "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 grade is ?, with the note “The four-hour trial did not test clinical arrhythmia.” Parent D30 biomarker-harm context is retained in its original role.", "condition_status": "Unverified", "status_reason": "Required direct definitions, values and materials are unverified within the current stored-summary/unread-external-material scope. Direct clinical occurrence, risks/CIs, testing and long-term materials are unverified. This preparation does not assess effects or grades.", "missingness": "Direct clinical occurrence, risks/CIs, testing and long-term materials are unverified. This preparation does not assess effects or grades.", "uncertainty": "Preparation scope of the stored summary. Direct clinical occurrence, risks/CIs, testing and long-term materials are unverified. This preparation does not assess effects or grades.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct clinical-event comparison/verification materials and user-provided originals" }, { "item_id": "H01", "question_type": "Clinical harms · Materials", "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. Direct materials for the selected clinical events are unverified.", "condition_status": "Unverified", "status_reason": "Required direct definitions, values and materials are unverified within the current stored-summary/unread-external-material scope. 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": "Clinical harms · Materials", "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": "Clinical harms · Materials", "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": "Unverified", "status_reason": "Required direct definitions, values and materials are unverified within the current stored-summary/unread-external-material scope. 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": "Clinical harms · Materials", "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": "Clinical harms · Materials", "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": "Clinical harms · Materials", "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": "Clinical harms · Materials", "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": "Clinical harms · Materials", "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": "Clinical harms · Materials", "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": "2026-10-06T16:33:13.845184+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": "2026-10-06T16:33:13.845184+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 38 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-12" }