{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3013-s0", "verdict_number": "3013", "title": "Oral sucrose solution administered by a clinician two minutes before vaccination × Reduced behavioral pain and crying after vaccination", "view_version": "1.0", "view_created_date": "2026-10-21", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-07", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Existing stored summary and preserved methodology application records. External papers, abstracts, registration, protocols, SAPs, original result tables and support disclosures are unread, and review of existing content remains incomplete.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "The question concerns infants receiving vaccination. Hatfield concerns healthy term infants aged 2 and 4 months; Allen concerns ages 2 weeks to 18 months. Vaccine, injection counts, baseline details and detailed eligibility remain unverified by report.", "intervention": "The intervention is clinician-administered oral sucrose. The key positive finding concerns 24% sucrose plus a pacifier; sucking, contact, holding and breastfeeding effects are not pooled as sucrose-only analgesia.", "dose": "Hatfield's 24% sucrose plus pacifier 2 minutes before vaccination is distinguished from Allen's 12% sucrose 2mL. Actual volumes, repetition, adherence and detailed amounts in other reports remain unverified. Research exposures are not converted into new use instructions.", "comparator": "Hatfield's sterile water, Allen's water and no intervention, and Gad's breastfeeding and control are distinguished. Detailed balance of amounts, contact, sucking, feeding and concurrent care remains unverified.", "endpoint": "The selected question concerns behavioral pain and crying after vaccination. Hatfield's behavioral scores, Allen's crying and Gad's FLACC, crying time and heart rate are separated; pain-specific EEG and spinal reflexes during a different heel-lance procedure are not used as the same endpoints.", "duration": "Hatfield concerns the context from 2 minutes before vaccination to 5, 7 and 9 minutes afterward. Measurement times, duration and actual exposure in other reports remain separately unverified. Findings are not extended to repeated routine soothing or long-term effects.", "excluded_extensions": [ "Attributing composite behavioral signals to sucrose alone", "Pooling water, no intervention, breastfeeding and different concentrations and ages as the same comparison", "Extending vaccination behavioral calming to complete pain elimination or blocked neural nociception", "Transferring physiological findings from separate heel lance into direct vaccination effects", "Adding denominators across shared reports or creating new effects, intervals, optimal doses or repeated-use instructions" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which post-vaccination behavioral-pain and crying claim is assessed?", "needed": "Boundary between vaccination behavior, crying and the separate neural-response question", "role": "Required", "role_reason": "Material on Boundary between vaccination behavior, crying and the separate neural-response question is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Boundary between vaccination behavior, crying and the separate neural-response question must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: Direct material linking the relevant vaccination, intervention, comparator and behavioral endpoint is needed. Behavioral signals are not extended to complete pain elimination. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03", "S04" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The selected question is reduced behavioral pain and crying after vaccination. Vaccination behavior is distinguished from pain-specific neural responses during a different procedure.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Direct material linking the relevant vaccination, intervention, comparator and behavioral endpoint is needed. Behavioral signals are not extended to complete pain elimination.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct material linking the relevant vaccination, intervention, comparator and behavioral endpoint is needed. Behavioral signals are not extended to complete pain elimination." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "How do selected C and parent C54 differ?", "needed": "Selected grade versus parent score, axes and the separate neural question", "role": "Required", "role_reason": "Material on Selected grade versus parent score, axes and the separate neural question is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Selected grade versus parent score, axes and the separate neural question must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: Question-specific verdict histories and original material are needed. Parent 54 points are not filled in as the selected item's score, and existing C is not presented as a new verdict. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03", "S04" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The selected behavioral-pain and crying item is C, with no individual score, status or axes. C54 is the parent account's grading context; the separate neural-response item is D.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Question-specific verdict histories and original material are needed. Parent 54 points are not filled in as the selected item's score, and existing C is not presented as a new verdict.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Question-specific verdict histories and original material are needed. Parent 54 points are not filled in as the selected item's score, and existing C is not presented as a new verdict." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What material was actually read in this work?", "needed": "Complete stored Korean and English summaries versus external reading", "role": "Required", "role_reason": "Material on Complete stored Korean and English summaries versus external reading is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Complete stored Korean and English summaries versus external reading must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: Original material and actual acquisition, access and reading records are needed for each material. Historical verification narratives or bibliographic links are not promoted into current full-text reading. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03", "S04" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The complete stored parent Korean and English accounts, 3 evidence summaries, 4 citations and 2 subquestions were read. External papers, registration, protocols and analysis plans are unread.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Original material and actual acquisition, access and reading records are needed for each material. Historical verification narratives or bibliographic links are not promoted into current full-text reading.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original material and actual acquisition, access and reading records are needed for each material. Historical verification narratives or bibliographic links are not promoted into current full-text reading." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What comparison did Hatfield's vaccination trial make?", "needed": "Identity of sucrose-plus-pacifier versus sterile water", "role": "Required", "role_reason": "Material on Identity of sucrose-plus-pacifier versus sterile water is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Identity of sucrose-plus-pacifier versus sterile water must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: The original paper, registration, intervention and result material are needed. The composite is not converted into sucrose-only efficacy, and bibliography is not labeled as external full-text reading. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Hatfield 2008, PMID18245406, DOI10.1542/peds.2006-3719 and NCT00150189 are retained. The key comparison is 24% sucrose plus a pacifier versus sterile water.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "The original paper, registration, intervention and result material are needed. The composite is not converted into sucrose-only efficacy, and bibliography is not labeled as external full-text reading.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The original paper, registration, intervention and result material are needed. The composite is not converted into sucrose-only efficacy, and bibliography is not labeled as external full-text reading." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What was Allen's sucrose, water and no-intervention comparison?", "needed": "Report distinguishing age, concentration and different controls", "role": "Required", "role_reason": "Material on Report distinguishing age, concentration and different controls is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Report distinguishing age, concentration and different controls must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: The original paper, group- and age-specific results and historical registration context are needed. The original account that registration did not exist before the registration era is not certified by a new comprehensive registry search. This records needed materials; no new research was executed.", "current_reports": [ "S02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Allen 1996, PMID8603220, DOI10.1001/archpedi.1996.02170280040007 and the randomized sucrose, water and no-intervention trial of 285 infants are retained.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "The original paper, group- and age-specific results and historical registration context are needed. The original account that registration did not exist before the registration era is not certified by a new comprehensive registry search.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The original paper, group- and age-specific results and historical registration context are needed. The original account that registration did not exist before the registration era is not certified by a new comprehensive registry search." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "What was Gad's breastfeeding comparison?", "needed": "Active comparison of sucrose, breastfeeding and control", "role": "Required", "role_reason": "Material on Active comparison of sucrose, breastfeeding and control is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Active comparison of sucrose, breastfeeding and control must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: Original group allocation, feeding, control, vaccination conditions and endpoint-specific denominators are needed. The active comparison is not transferred to sucrose-only analgesia or a direct neural-response effect. This records needed materials; no new research was executed.", "current_reports": [ "S03" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Gad 2019, PMID30807328, DOI10.1097/NMC.0000000000000512 and the 3-arm vaccination trial of 120 infants are retained.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Original group allocation, feeding, control, vaccination conditions and endpoint-specific denominators are needed. The active comparison is not transferred to sucrose-only analgesia or a direct neural-response effect.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original group allocation, feeding, control, vaccination conditions and endpoint-specific denominators are needed. The active comparison is not transferred to sucrose-only analgesia or a direct neural-response effect." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Does Slater's heel-lance trial answer the same question?", "needed": "Different procedure, pain-specific EEG and a citation-only report", "role": "Required", "role_reason": "Material on Different procedure, pain-specific EEG and a citation-only report is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Different procedure, pain-specific EEG and a citation-only report must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: The original paper, registration, procedure, EEG and behavioral material are needed. It is not transferred into direct replication of vaccination behavior or proof of blocked neural nociception during vaccination. This records needed materials; no new research was executed.", "current_reports": [ "S04" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Slater 2010, PMID20817247, DOI10.1016/S0140-6736(10)61303-7 and ISRCTN78390996 concern a separate neonatal heel-lance trial. It appears only in the stored bibliography, with no separate evidence-summary entry.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "The original paper, registration, procedure, EEG and behavioral material are needed. It is not transferred into direct replication of vaccination behavior or proof of blocked neural nociception during vaccination.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The original paper, registration, procedure, EEG and behavioral material are needed. It is not transferred into direct replication of vaccination behavior or proof of blocked neural nociception during vaccination." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Are reports and participants counted more than once?", "needed": "Shared reports, subquestions, trials and analysis denominators", "role": "Required", "role_reason": "Material on Shared reports, subquestions, trials and analysis denominators is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Shared reports, subquestions, trials and analysis denominators must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: Trial flows and related report and population relationships are needed. Different denominators are not added into new participant or independent-replication totals, and heel-lance participants are not inserted into vaccination denominators. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03", "S04" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The selected behavioral-pain question and the separate neural question share parent reports. The 100 randomized and 83 analyzed infants, 285 infants and 120 infants are retained in their respective report contexts.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Trial flows and related report and population relationships are needed. Different denominators are not added into new participant or independent-replication totals, and heel-lance participants are not inserted into vaccination denominators.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial flows and related report and population relationships are needed. Different denominators are not added into new participant or independent-replication totals, and heel-lance participants are not inserted into vaccination denominators." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Which ages and vaccination conditions were studied?", "needed": "Healthy term infants, age, vaccine, injection count and eligibility", "role": "Required", "role_reason": "Material on Healthy term infants, age, vaccine, injection count and eligibility is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Healthy term infants, age, vaccine, injection count and eligibility must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: Eligibility, baseline characteristics, age, vaccine and injection counts are needed. Applicability to preterm or ill infants and other vaccination conditions remains unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Hatfield concerns healthy term infants, with ages 2 and 4 months in the citation title; Allen concerns ages 2 weeks to 18 months. Randomized and analyzed sample sizes are separate from eligibility criteria.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Eligibility, baseline characteristics, age, vaccine and injection counts are needed. Applicability to preterm or ill infants and other vaccination conditions remains unverified.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility, baseline characteristics, age, vaccine and injection counts are needed. Applicability to preterm or ill infants and other vaccination conditions remains unverified." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Were concentration, volume and administration timing the same?", "needed": "Reported nominal concentration versus actual exposure", "role": "Required", "role_reason": "Material on Reported nominal concentration versus actual exposure is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Reported nominal concentration versus actual exposure must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: Report-specific actual volumes, repetition, adherence, product specifications and Gad's detailed dose are needed. General administration wording is not converted into new quantitative doses. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Hatfield used 24% sucrose plus a pacifier 2 minutes before vaccination, while Allen used 12% sucrose 2mL, as retained in the stored account.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Report-specific actual volumes, repetition, adherence, product specifications and Gad's detailed dose are needed. General administration wording is not converted into new quantitative doses.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-specific actual volumes, repetition, adherence, product specifications and Gad's detailed dose are needed. General administration wording is not converted into new quantitative doses." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Were pacifier, holding and breastfeeding effects separated?", "needed": "Sweet taste, nonnutritive sucking, contact and feeding", "role": "Required", "role_reason": "Material on Sweet taste, nonnutritive sucking, contact and feeding is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Sweet taste, nonnutritive sucking, contact and feeding must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: Group-specific concurrent care, adherence and direct comparisons separating ingredients, sucking and contact are needed. Composite results alone do not establish the contribution of sucrose alone. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S03" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The key positive result concerns sucrose plus a pacifier. The stored account does not attribute sucking, holding and breastfeeding effects to analgesia from sucrose alone.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Group-specific concurrent care, adherence and direct comparisons separating ingredients, sucking and contact are needed. Composite results alone do not establish the contribution of sucrose alone.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific concurrent care, adherence and direct comparisons separating ingredients, sucking and contact are needed. Composite results alone do not establish the contribution of sucrose alone." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Are sterile water, water, no intervention and breastfeeding the same control?", "needed": "Actual comparisons and contact and administration conditions", "role": "Required", "role_reason": "Material on Actual comparisons and contact and administration conditions is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Actual comparisons and contact and administration conditions must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: Actual amounts, administration, contact, sucking, feeding and concurrent care are needed for each control. The comparisons are not pooled as the same placebo. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Hatfield's sterile water, Allen's water and no intervention, and Gad's breastfeeding and control are different comparisons.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Actual amounts, administration, contact, sucking, feeding and concurrent care are needed for each control. The comparisons are not pooled as the same placebo.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual amounts, administration, contact, sucking, feeding and concurrent care are needed for each control. The comparisons are not pooled as the same placebo." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Were randomization and blinding verified?", "needed": "Allocation, concealment, assessors, expectations and measurement bias", "role": "Required", "role_reason": "Material on Allocation, concealment, assessors, expectations and measurement bias is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Allocation, concealment, assessors, expectations and measurement bias must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: Original allocation, concealment, assessor, parent and clinician blinding and baseline-balance material are needed. Design labels alone do not complete bias assessment. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The stored randomized designs, Allen's double-blind description and Gad's active-control and unblinded flag are retained.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Original allocation, concealment, assessor, parent and clinician blinding and baseline-balance material are needed. Design labels alone do not complete bias assessment.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original allocation, concealment, assessor, parent and clinician blinding and baseline-balance material are needed. Design labels alone do not complete bias assessment." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Are behavior scores, crying, FLACC and heart rate the same outcome?", "needed": "Endpoint definitions, scales, times, primary and secondary hierarchy", "role": "Required", "role_reason": "Material on Endpoint definitions, scales, times, primary and secondary hierarchy is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Endpoint definitions, scales, times, primary and secondary hierarchy must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: Scale, crying and heart-rate methods, times and endpoint tables are needed. Behavior, crying, heart rate and EEG are not pooled as one outcome, and a list alone does not establish positive findings for all of them. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Hatfield's behavioral pain at 5, 7 and 9 minutes, Allen's crying during vaccination, and Gad's FLACC, crying-time and heart-rate endpoint list are retained separately.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Scale, crying and heart-rate methods, times and endpoint tables are needed. Behavior, crying, heart rate and EEG are not pooled as one outcome, and a list alone does not establish positive findings for all of them.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Scale, crying and heart-rate methods, times and endpoint tables are needed. Behavior, crying, heart rate and EEG are not pooled as one outcome, and a list alone does not establish positive findings for all of them." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "What were the time-specific results and 7-minute means?", "needed": "Time-specific composite results, denominators and precision", "role": "Required", "role_reason": "Material on Time-specific composite results, denominators and precision is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Time-specific composite results, denominators and precision must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: Baseline or change definitions, scale units, time-specific denominators, variability, exact P values and CIs are needed. New differences or intervals are not calculated from the given means. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The stored summary reports lower behavioral-pain scores with Hatfield's composite at each time, with 7-minute means of 3.8 versus 4.8.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Baseline or change definitions, scale units, time-specific denominators, variability, exact P values and CIs are needed. New differences or intervals are not calculated from the given means.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline or change definitions, scale units, time-specific denominators, variability, exact P values and CIs are needed. New differences or intervals are not calculated from the given means." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "How do randomized, analyzed and excluded infant counts differ?", "needed": "Original allocation versus group- and endpoint-specific analysis and missingness", "role": "Required", "role_reason": "Material on Original allocation versus group- and endpoint-specific analysis and missingness is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Original allocation versus group- and endpoint-specific analysis and missingness must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: Group-specific allocation, measurement, exclusion reasons, denominators, ITT, PP and sensitivity material are needed. Randomized counts do not replace analysis denominators, and no new exclusion rate is calculated. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Hatfield's 100 randomized and 83 analyzed infants, 38 versus 45, and the parent account's 17 analysis exclusions are retained unchanged.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Group-specific allocation, measurement, exclusion reasons, denominators, ITT, PP and sensitivity material are needed. Randomized counts do not replace analysis denominators, and no new exclusion rate is calculated.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific allocation, measurement, exclusion reasons, denominators, ITT, PP and sensitivity material are needed. Randomized counts do not replace analysis denominators, and no new exclusion rate is calculated." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Was the lack of a sucrose-specific advantage over water also retained?", "needed": "Age-specific water and no-intervention comparisons and uncertainty", "role": "Required", "role_reason": "Material on Age-specific water and no-intervention comparisons and uncertainty is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Age-specific water and no-intervention comparisons and uncertainty must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: Original age- and group-specific results, denominators, intervals and prespecified plans are needed. This is not converted into effect 0 at every age or concentration, or precise equivalence with water. This records needed materials; no new research was executed.", "current_reports": [ "S02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Allen's original result is retained: at 2 weeks, sucrose and water both reduced crying versus no intervention, without a sucrose-specific effect.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Original age- and group-specific results, denominators, intervals and prespecified plans are needed. This is not converted into effect 0 at every age or concentration, or precise equivalence with water.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original age- and group-specific results, denominators, intervals and prespecified plans are needed. This is not converted into effect 0 at every age or concentration, or precise equivalence with water." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Which endpoints showed breastfeeding superiority?", "needed": "Pain and crying versus separate heart-rate findings", "role": "Required", "role_reason": "Material on Pain and crying versus separate heart-rate findings is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Pain and crying versus separate heart-rate findings must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: Endpoint-specific effects, CIs, group denominators, feeding and control conditions and heart-rate results are needed. Breastfeeding superiority is not absorbed into sucrose-only efficacy. This records needed materials; no new research was executed.", "current_reports": [ "S03" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The stored account reports that breastfeeding was superior to sucrose and control for pain and crying in the 120-infant trial, with P<.001.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Endpoint-specific effects, CIs, group denominators, feeding and control conditions and heart-rate results are needed. Breastfeeding superiority is not absorbed into sucrose-only efficacy.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoint-specific effects, CIs, group denominators, feeding and control conditions and heart-rate results are needed. Breastfeeding superiority is not absorbed into sucrose-only efficacy." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Were registration, prespecified endpoints and multiple times verified?", "needed": "Registration history, protocol, analysis plan and endpoint hierarchy", "role": "Required", "role_reason": "Material on Registration history, protocol, analysis plan and endpoint hierarchy is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Registration history, protocol, analysis plan and endpoint hierarchy must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: Registration changes, protocols, analysis plans and complete results are needed. An identifier alone does not establish prespecified primary endpoints, multiplicity handling or agreement with the plan. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Hatfield's NCT00150189, Gad's unverified registration and Allen's pre-registration-era narrative are retained. Current registration and plan material are unread.", "condition_status": "Unverified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Registration changes, protocols, analysis plans and complete results are needed. An identifier alone does not establish prespecified primary endpoints, multiplicity handling or agreement with the plan.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration changes, protocols, analysis plans and complete results are needed. An identifier alone does not establish prespecified primary endpoints, multiplicity handling or agreement with the plan." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Can findings be generalized across concentration, age and repeated use?", "needed": "Direct concentration, population, injection count, repetition and durability", "role": "Required", "role_reason": "Material on Direct concentration, population, injection count, repetition and durability is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Direct concentration, population, injection count, repetition and durability must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: Direct concentration, age, injection-count, repeated-use and subgroup material are needed. Cross-trial comparisons do not newly determine an optimal dose, effects in all infants or long-term effects. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The stored account does not establish sucrose-only efficacy or an optimal dose because concentration, age, injection counts and simultaneous pacifier use differ.", "condition_status": "Unverified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Direct concentration, age, injection-count, repeated-use and subgroup material are needed. Cross-trial comparisons do not newly determine an optimal dose, effects in all infants or long-term effects.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct concentration, age, injection-count, repeated-use and subgroup material are needed. Cross-trial comparisons do not newly determine an optimal dose, effects in all infants or long-term effects." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Does behavioral calming mean reduced pain-specific neural responses?", "needed": "Vaccination behavior versus separate heel-lance EEG and spinal reflexes", "role": "Required", "role_reason": "Material on Vaccination behavior versus separate heel-lance EEG and spinal reflexes is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Vaccination behavior versus separate heel-lance EEG and spinal reflexes must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: Direct material linking behavioral, neural and physiological outcomes within the same procedure is needed. Positive vaccination behavior is not transferred into complete nociceptive blockade, and null findings from another procedure do not erase behavioral reports. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03", "S04" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The stored account distinguishes less visible pain behavior from reduced neural nociception. The null EEG primary endpoint during separate heel lance is retained separately.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Direct material linking behavioral, neural and physiological outcomes within the same procedure is needed. Positive vaccination behavior is not transferred into complete nociceptive blockade, and null findings from another procedure do not erase behavioral reports.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct material linking behavioral, neural and physiological outcomes within the same procedure is needed. Positive vaccination behavior is not transferred into complete nociceptive blockade, and null findings from another procedure do not erase behavioral reports." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "What funding, product support and interests were verified?", "needed": "Support indexing, manufacturers, products, employment and COI", "role": "Required", "role_reason": "Material on Support indexing, manufacturers, products, employment and COI is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Support indexing, manufacturers, products, employment and COI must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: Original funding, product provision, employment and COI disclosures are needed. Indexing or manufacturer narratives are not extended into absence of all interests, absence of bias or current independence certification. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Hatfield's non-U.S. government-support indexing and no-manufacturer-involvement narrative, and Allen's and Gad's unverified specific funding and COI, are retained at the stored-account level.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Original funding, product provision, employment and COI disclosures are needed. Indexing or manufacturer narratives are not extended into absence of all interests, absence of bias or current independence certification.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding, product provision, employment and COI disclosures are needed. Indexing or manufacturer narratives are not extended into absence of all interests, absence of bias or current independence certification." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are harm events and exposure denominators known?", "needed": "Aspiration and other events, collection, withdrawal, exposure and time", "role": "Supplementary", "role_reason": "Material on Aspiration and other events, collection, withdrawal, exposure and time is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Aspiration and other events, collection, withdrawal, exposure and time must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: Trial-specific events, collection methods, withdrawals, group exposure denominators and observation periods are needed. Less visible behavior is not judged as safety or absence of harms. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original caution and clinician-administered small amounts at a specified concentration are retained. The original caution concerning infants at aspiration risk is also retained.", "condition_status": "Unverified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Trial-specific events, collection methods, withdrawals, group exposure denominators and observation periods are needed. Less visible behavior is not judged as safety or absence of harms.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-specific events, collection methods, withdrawals, group exposure denominators and observation periods are needed. Less visible behavior is not judged as safety or absence of harms." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "What about vulnerable groups, repeated or long-term harms and use instructions?", "needed": "Comparative exposure, concurrent care, baseline risks, timing and repetition", "role": "Supplementary", "role_reason": "Material on Comparative exposure, concurrent care, baseline risks, timing and repetition is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Comparative exposure, concurrent care, baseline risks, timing and repetition must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: Group exposures, concurrent care, baseline risks, withdrawal, recovery, repeated and long-term event material are needed. Absence of rare harms, ingredient causality, comparative risks or new incidence rates is not established. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The account's restriction against improvised concentrations or repeated routine soothing and its clinician context are retained. This evidence table creates no new use, administration or individual-care instructions.", "condition_status": "Unverified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Group exposures, concurrent care, baseline risks, withdrawal, recovery, repeated and long-term event material are needed. Absence of rare harms, ingredient causality, comparative risks or new incidence rates is not established.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group exposures, concurrent care, baseline risks, withdrawal, recovery, repeated and long-term event material are needed. Absence of rare harms, ingredient causality, comparative risks or new incidence rates is not established." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "What records do the grades, languages, axes and evidence date represent?", "needed": "Selected grade versus parent context, original dates and empty change records", "role": "Required", "role_reason": "Material on Selected grade versus parent context, original dates and empty change records is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created.", "criterion": "Original material on Selected grade versus parent context, original dates and empty change records must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing post-vaccination behavioral-pain and crying question. They do not establish preregistration, execution of an official tool or completed clinical content review.", "proposed_research": "Material needed: Question-specific verdicts, changes and additional material are needed. Historical cross-checks and parent axes are not inherited as current completed review or new axes for the selected item. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03", "S04" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Selected C and absent individual score and axes, parent C54, original Korean and English accounts, axes and evidence date 2026-09-07 are retained. The original correction list and separate deliberation record are empty.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Question-specific verdicts, changes and additional material are needed. Historical cross-checks and parent axes are not inherited as current completed review or new axes for the selected item.", "uncertainty": "Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Question-specific verdicts, changes and additional material are needed. Historical cross-checks and parent axes are not inherited as current completed review or new axes for the selected item." } ], "reports": [ { "report_id": "S01", "title": "Hatfield LA et al. 2008", "url": "https://pubmed.ncbi.nlm.nih.gov/18245406/", "report_type": "Randomized vaccination trial of sucrose plus pacifier versus sterile water", "existence": "Stored bibliographic link exists; external identity, availability, acquisition and reading remain unverified", "acquired_read": "The complete stored parent Korean and English accounts and bibliography were read. External papers, registration, protocols, analysis plans and support disclosures are unread.", "study_family": "The behavioral-pain and crying question and the separate neural-response question share parent reports. Vaccination interventions, controls, ages and denominators are distinguished from separate heel lance. Report slots and family links are not added into new unique trial, participant or independent-replication counts; those totals remain unverified.", "independent_replication": "The behavioral-pain and crying question and the separate neural-response question share parent reports. Vaccination interventions, controls, ages and denominators are distinguished from separate heel lance. Report slots and family links are not added into new unique trial, participant or independent-replication counts; those totals remain unverified.", "observed_result": "100 infants randomized and 83 analyzed, 38 versus 45. Behavioral-pain scores with 24% sucrose plus a pacifier were lower at 5, 7 and 9 minutes; 7-minute means were 3.8 versus 4.8. The account's 17 analysis exclusions are also retained.", "result_level": "These are stored composite-intervention findings. Original group allocation, exclusion reasons, time-specific variability, denominators and original CIs remain unverified. They are not promoted into sucrose-only contribution, complete nociceptive blockade or current independence certification.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "PMID18245406, DOI10.1542/peds.2006-3719 and NCT00150189 are linked to the original bibliography. The empty original registration field is distinguished from the citation identifier; registration, plans and full text are unread. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates." }, { "material_type": "External paper", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID18245406, DOI10.1542/peds.2006-3719 and NCT00150189 are linked to the original bibliography. The empty original registration field is distinguished from the citation identifier; registration, plans and full text are unread. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID18245406, DOI10.1542/peds.2006-3719 and NCT00150189 are linked to the original bibliography. The empty original registration field is distinguished from the citation identifier; registration, plans and full text are unread. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID18245406, DOI10.1542/peds.2006-3719 and NCT00150189 are linked to the original bibliography. The empty original registration field is distinguished from the citation identifier; registration, plans and full text are unread. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates." }, { "material_type": "Statistical analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID18245406, DOI10.1542/peds.2006-3719 and NCT00150189 are linked to the original bibliography. The empty original registration field is distinguished from the citation identifier; registration, plans and full text are unread. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates." }, { "material_type": "Funding, product support and COI material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID18245406, DOI10.1542/peds.2006-3719 and NCT00150189 are linked to the original bibliography. The empty original registration field is distinguished from the citation identifier; registration, plans and full text are unread. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/18245406/" } ] }, { "report_id": "S02", "title": "Allen KD et al. 1996", "url": "https://pubmed.ncbi.nlm.nih.gov/8603220/", "report_type": "Double-blind randomized vaccination trial of sucrose, water and no intervention", "existence": "Stored bibliographic link exists; external identity, availability, acquisition and reading remain unverified", "acquired_read": "The complete stored parent Korean and English accounts and bibliography were read. External papers, registration, protocols, analysis plans and support disclosures are unread.", "study_family": "The behavioral-pain and crying question and the separate neural-response question share parent reports. Vaccination interventions, controls, ages and denominators are distinguished from separate heel lance. Report slots and family links are not added into new unique trial, participant or independent-replication counts; those totals remain unverified.", "independent_replication": "The behavioral-pain and crying question and the separate neural-response question share parent reports. Vaccination interventions, controls, ages and denominators are distinguished from separate heel lance. Report slots and family links are not added into new unique trial, participant or independent-replication counts; those totals remain unverified.", "observed_result": "285 infants aged 2 weeks to 18 months. The original account reports that 12% sucrose 2mL and water both reduced crying versus no intervention at 2 weeks, without a sucrose-specific effect.", "result_level": "These are stored findings specific to age, concentration and controls. They are not converted into effect 0 at every age or precise equivalence with water. Unverified funding and COI, and the pre-registration-era narrative, are not promoted into current searches or certification.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "PMID8603220 and DOI10.1001/archpedi.1996.02170280040007 are retained. The pre-registration-era account is an original narrative; empty registration fields are not replaced with a new number, search or not-applicable judgment. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates." }, { "material_type": "External paper", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID8603220 and DOI10.1001/archpedi.1996.02170280040007 are retained. The pre-registration-era account is an original narrative; empty registration fields are not replaced with a new number, search or not-applicable judgment. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID8603220 and DOI10.1001/archpedi.1996.02170280040007 are retained. The pre-registration-era account is an original narrative; empty registration fields are not replaced with a new number, search or not-applicable judgment. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID8603220 and DOI10.1001/archpedi.1996.02170280040007 are retained. The pre-registration-era account is an original narrative; empty registration fields are not replaced with a new number, search or not-applicable judgment. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates." }, { "material_type": "Statistical analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID8603220 and DOI10.1001/archpedi.1996.02170280040007 are retained. The pre-registration-era account is an original narrative; empty registration fields are not replaced with a new number, search or not-applicable judgment. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates." }, { "material_type": "Funding, product support and COI material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID8603220 and DOI10.1001/archpedi.1996.02170280040007 are retained. The pre-registration-era account is an original narrative; empty registration fields are not replaced with a new number, search or not-applicable judgment. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/8603220/" } ] }, { "report_id": "S03", "title": "Gad RF et al. 2019", "url": "https://pubmed.ncbi.nlm.nih.gov/30807328/", "report_type": "3-arm randomized vaccination trial of sucrose, breastfeeding and control", "existence": "Stored bibliographic link exists; external identity, availability, acquisition and reading remain unverified", "acquired_read": "The complete stored parent Korean and English accounts and bibliography were read. External papers, registration, protocols, analysis plans and support disclosures are unread.", "study_family": "The behavioral-pain and crying question and the separate neural-response question share parent reports. Vaccination interventions, controls, ages and denominators are distinguished from separate heel lance. Report slots and family links are not added into new unique trial, participant or independent-replication counts; those totals remain unverified.", "independent_replication": "The behavioral-pain and crying question and the separate neural-response question share parent reports. Vaccination interventions, controls, ages and denominators are distinguished from separate heel lance. Report slots and family links are not added into new unique trial, participant or independent-replication counts; those totals remain unverified.", "observed_result": "The stored account reports that breastfeeding was superior to sucrose and control for pain and crying in a trial of 120 infants, with P<.001.", "result_level": "FLACC, crying time and heart rate are the original endpoint list. Individual heart-rate findings, group denominators, exact effects and CIs remain unverified. Breastfeeding superiority is not transferred to sucrose-only effects or reduced neural responses.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "PMID30807328 and DOI10.1097/NMC.0000000000000512 are retained. Unverified registration, funding and COI and the unblinded flag are retained without promotion into current independence or efficacy certification. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates." }, { "material_type": "External paper", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID30807328 and DOI10.1097/NMC.0000000000000512 are retained. Unverified registration, funding and COI and the unblinded flag are retained without promotion into current independence or efficacy certification. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID30807328 and DOI10.1097/NMC.0000000000000512 are retained. Unverified registration, funding and COI and the unblinded flag are retained without promotion into current independence or efficacy certification. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID30807328 and DOI10.1097/NMC.0000000000000512 are retained. Unverified registration, funding and COI and the unblinded flag are retained without promotion into current independence or efficacy certification. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates." }, { "material_type": "Statistical analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID30807328 and DOI10.1097/NMC.0000000000000512 are retained. Unverified registration, funding and COI and the unblinded flag are retained without promotion into current independence or efficacy certification. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates." }, { "material_type": "Funding, product support and COI material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID30807328 and DOI10.1097/NMC.0000000000000512 are retained. Unverified registration, funding and COI and the unblinded flag are retained without promotion into current independence or efficacy certification. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/30807328/" } ] }, { "report_id": "S04", "title": "Slater R et al. 2010", "url": "https://pubmed.ncbi.nlm.nih.gov/20817247/", "report_type": "Citation-only randomized trial during separate neonatal heel lance", "existence": "Stored bibliographic link exists; external identity, availability, acquisition and reading remain unverified", "acquired_read": "The complete stored parent Korean and English accounts and bibliography were read. External papers, registration, protocols, analysis plans and support disclosures are unread.", "study_family": "The behavioral-pain and crying question and the separate neural-response question share parent reports. Vaccination interventions, controls, ages and denominators are distinguished from separate heel lance. Report slots and family links are not added into new unique trial, participant or independent-replication counts; those totals remain unverified.", "independent_replication": "The behavioral-pain and crying question and the separate neural-response question share parent reports. Vaccination interventions, controls, ages and denominators are distinguished from separate heel lance. Report slots and family links are not added into new unique trial, participant or independent-replication counts; those totals remain unverified.", "observed_result": "The parent account distinguishes the null prespecified pain-specific EEG primary endpoint during separate heel lance from behavioral-score differences and spinal reflexes. There is no separate entry in the stored evidence-summary list.", "result_level": "This is stored context from another procedure and endpoint. Exact concentration, volume, timing, sample size and quantitative neural findings are unlinked. Vaccination doses, ages and denominators are not transferred to this trial, and it is not counted as direct replication of vaccination behavior.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "PMID20817247, DOI10.1016/S0140-6736(10)61303-7 and ISRCTN78390996 appear in the original citation. Citation-only status and the empty original registration field are retained; no new evidence-summary entry or direct vaccination evidence is created. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates." }, { "material_type": "External paper", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID20817247, DOI10.1016/S0140-6736(10)61303-7 and ISRCTN78390996 appear in the original citation. Citation-only status and the empty original registration field are retained; no new evidence-summary entry or direct vaccination evidence is created. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID20817247, DOI10.1016/S0140-6736(10)61303-7 and ISRCTN78390996 appear in the original citation. Citation-only status and the empty original registration field are retained; no new evidence-summary entry or direct vaccination evidence is created. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID20817247, DOI10.1016/S0140-6736(10)61303-7 and ISRCTN78390996 appear in the original citation. Citation-only status and the empty original registration field are retained; no new evidence-summary entry or direct vaccination evidence is created. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates." }, { "material_type": "Statistical analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID20817247, DOI10.1016/S0140-6736(10)61303-7 and ISRCTN78390996 appear in the original citation. Citation-only status and the empty original registration field are retained; no new evidence-summary entry or direct vaccination evidence is created. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates." }, { "material_type": "Funding, product support and COI material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID20817247, DOI10.1016/S0140-6736(10)61303-7 and ISRCTN78390996 appear in the original citation. Citation-only status and the empty original registration field are retained; no new evidence-summary entry or direct vaccination evidence is created. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/20817247/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." } ], "status_dictionary": { "Partly verified": "Partial information from the stored summary is linked; detailed originals and content review remain incomplete.", "Unverified": "Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.", "Review incomplete": "Review of existing content remains incomplete.", "Met": "This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.", "Not reported": "Unreported within material actually read. Unread external material is not relabeled as unreported.", "Inaccessible": "This means actual access failure. External access was not attempted in this work, so this state was not assigned.", "Not applicable": "Used only with an application exception and reason based on the question scope.", "Conflicting data": "This requires actual comparison of materials; no new conflict judgment was made in this work.", "Insufficient evidence for the conditions": "This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The behavioral-pain and crying question and the separate neural-response question share parent reports. Vaccination interventions, controls, ages and denominators are distinguished from separate heel lance. Report slots and family links are not added into new unique trial, participant or independent-replication counts; those totals remain unverified." }, "history": [ { "date": "2026-10-21", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public-facing views and materials were prepared from the existing 25 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-21" }