{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3011-s1", "verdict_number": "3011", "title": "Caregiver-delivered infant massage × Increased sleep duration", "view_version": "1.0", "view_created_date": "2026-10-20", "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 direct sleep report S02 records 100 infants, all completed. Colic definitions, age, eligibility and arm-specific sleep analysis denominators remain unverified. S01's 58 infants do not replace them.", "intervention": "Infant massage delivered by trained caregivers. It is distinguished from lavender combinations and nurse delivery, without repurposing findings as oil-ingredient effects.", "dose": "Session length, frequency, intensity and total contact in the direct sleep trial are unlinked. A program name is not a quantitative dose, and no new procedure is created.", "comparator": "Direct sleep is linked to S02 rocking control. Contact and expectation differences remain; S01 crib vibration, kangaroo care and usual care are not merged into the same sleep comparison.", "endpoint": "The selected question is increased parent-diary sleep duration. Baseline 9.22 versus 12.24 h is distinguished from favorable sleep narratives. Final values, changes, adjusted between-group effects, CIs, P values and prespecified hierarchy are unlinked.", "duration": "Direct sleep report S02 covers 1 week. It is distinguished from S01's 3-week crying findings; long-term durability is uncertain.", "excluded_extensions": [ "Calculating new between-group differences, effects, CIs or adjusted net effects from original reductions or baseline values", "Certifying a massage-specific effect with referral-day allocation, parent diaries, natural history, contact and baseline differences removed", "Promoting improved crying or sleep into cure of colic, long-term durability or clinical events", "Using completion records as valid denominators for every diary, arm, endpoint or harm, or as absence of events", "Adding same-cohort reanalyses, shared reports, combined oils or professional delivery as independent replications", "Inheriting historical registration narratives, identifiers or cross-checks as current external verification", "Creating new massage procedures, treatment or individual diagnostic guidance, oil-ingredient efficacy claims or clinical verdicts" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "How do selected sleep C and parent C46 differ?", "needed": "Selected sleep question, grade and note versus the parent crying-and-sleep verdict", "role": "Required", "role_reason": "Material on Selected sleep question, grade and note versus the parent crying-and-sleep verdict is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Selected sleep question, grade and note versus the parent crying-and-sleep verdict must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: The selected record has no separate score, status or axes. Distinguish original selected and parent records from new changes without filling in parent values. This records needed materials; no new research was executed.", "current_reports": [ "S01", "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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "The selected question is increased sleep duration, graded C. A short parent-diary report and uncertain long-term durability are retained together. Parent C46 is the overall crying-and-sleep context.", "condition_status": "Partly verified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "The selected record has no separate score, status or axes. Distinguish original selected and parent records from new changes without filling in parent values.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The selected record has no separate score, status or axes. Distinguish original selected and parent records from new changes without filling in parent values." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Who was eligible for the sleep trial?", "needed": "Colic definition, age and recruitment for the direct sleep report", "role": "Required", "role_reason": "Material on Colic definition, age and recruitment for the direct sleep report is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Colic definition, age and recruitment for the direct sleep report must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: S02 colic definition, age, comorbidities, eligibility, exclusions, recruitment routes and original participant flow are needed. 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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "S02 records 100 infants, all completed. S01's 58 infants belong to a separate 3-week crying trial and do not replace the selected sleep population or denominator.", "condition_status": "Partly verified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "S02 colic definition, age, comorbidities, eligibility, exclusions, recruitment routes and original participant flow are needed.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S02 colic definition, age, comorbidities, eligibility, exclusions, recruitment routes and original participant flow are needed." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What comprised caregiver massage?", "needed": "Caregiver training, sessions, intensity, frequency and total contact", "role": "Required", "role_reason": "Material on Caregiver training, sessions, intensity, frequency and total contact is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Caregiver training, sessions, intensity, frequency and total contact must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: S02 training and massage manuals, session length, intensity, frequency, delivery diaries and actual contact are needed. No new procedure is created. 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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "The account states that caregivers were taught a specified massage method. The program name is not treated as a quantitative dose.", "condition_status": "Partly verified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "S02 training and massage manuals, session length, intensity, frequency, delivery diaries and actual contact are needed. No new procedure is created.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S02 training and massage manuals, session length, intensity, frequency, delivery diaries and actual contact are needed. No new procedure is created." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Were rocking and contact matched?", "needed": "S02 rocking procedures and contact and expectations in both arms", "role": "Required", "role_reason": "Material on S02 rocking procedures and contact and expectations in both arms is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on S02 rocking procedures and contact and expectations in both arms must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Rocking procedures, frequency, time, contact in both arms, parent expectations and intervention manuals must be linked. 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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "S02 is a quasi-random massage-versus-rocking trial. The original limitation concerning different comparator contact is retained.", "condition_status": "Partly verified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "Rocking procedures, frequency, time, contact in both arms, parent expectations and intervention manuals must be linked.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Rocking procedures, frequency, time, contact in both arms, parent expectations and intervention manuals must be linked." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What is known about referral-day allocation and concealment?", "needed": "Allocation rules, sequence, concealment and recruitment staff access", "role": "Required", "role_reason": "Material on Allocation rules, sequence, concealment and recruitment staff access is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Allocation rules, sequence, concealment and recruitment staff access must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: S02 allocation lists, concealment, recruitment procedures, predictability and the original protocol are needed. No new bias judgment is made. 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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "The preserved design uses quasi-random referral-day allocation. Randomized-trial wording in the bibliographic title is also preserved in the original.", "condition_status": "Partly verified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "S02 allocation lists, concealment, recruitment procedures, predictability and the original protocol are needed. No new bias judgment is made.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S02 allocation lists, concealment, recruitment procedures, predictability and the original protocol are needed. No new bias judgment is made." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Did sleep recorders and assessors know the intervention?", "needed": "Blinding of caregivers, instructors, assessors and analysts", "role": "Required", "role_reason": "Material on Blinding of caregivers, instructors, assessors and analysts is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Blinding of caregivers, instructors, assessors and analysts must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: S02 diary instructions, roles, assessor and analyst blinding, and safeguards against expectation bias are needed. 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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "The original account retains unblinded parents recording diaries as a limitation.", "condition_status": "Partly verified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "S02 diary instructions, roles, assessor and analyst blinding, and safeguards against expectation bias are needed.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S02 diary instructions, roles, assessor and analyst blinding, and safeguards against expectation bias are needed." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "How was parent-diary sleep duration defined?", "needed": "Sleep onset, end, naps, nighttime sleep, recording windows and calculation rules", "role": "Required", "role_reason": "Material on Sleep onset, end, naps, nighttime sleep, recording windows and calculation rules is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Sleep onset, end, naps, nighttime sleep, recording windows and calculation rules must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original sleep diaries, scoring rules, units, recording windows, inclusion of naps and correspondence with objective measures are needed. 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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "The selected note reports increased sleep in a short parent-diary trial. S02 lists 1-week crying frequency, duration and sleep, while detailed sleep definitions remain unlinked.", "condition_status": "Partly verified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "Original sleep diaries, scoring rules, units, recording windows, inclusion of naps and correspondence with objective measures are needed.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original sleep diaries, scoring rules, units, recording windows, inclusion of naps and correspondence with objective measures are needed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What sleep values are 9.22 versus 12.24 h?", "needed": "Arm-specific baseline sleep, distributions, variance and adjustment plans", "role": "Required", "role_reason": "Material on Arm-specific baseline sleep, distributions, variance and adjustment plans is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Arm-specific baseline sleep, distributions, variance and adjustment plans must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Arm assignment for each value, SDs, distributions, measurement windows, baseline tables and prespecified adjustment plans are needed. 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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "S02's 9.22 versus 12.24 h represents baseline sleep imbalance. It is not converted into final values, changes or adjusted between-group effects, and no difference is calculated.", "condition_status": "Partly verified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "Arm assignment for each value, SDs, distributions, measurement windows, baseline tables and prespecified adjustment plans are needed.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm assignment for each value, SDs, distributions, measurement windows, baseline tables and prespecified adjustment plans are needed." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Can the 1-week sleep signal be linked to quantitative results?", "needed": "Final sleep, arm-specific changes, between-group estimates, CIs and P values", "role": "Required", "role_reason": "Material on Final sleep, arm-specific changes, between-group estimates, CIs and P values is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Final sleep, arm-specific changes, between-group estimates, CIs and P values must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: S02 final sleep duration, arm-specific changes, between-group sleep effects, CIs, P values, original result tables and supplements are needed. Baseline values do not fill effect gaps. 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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "The parent Korean and English accounts and selected note describe favorable sleep in a short trial. Preserved quantitative sleep values, 9.22 versus 12.24 h, are baseline values.", "condition_status": "Unverified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "S02 final sleep duration, arm-specific changes, between-group sleep effects, CIs, P values, original result tables and supplements are needed. Baseline values do not fill effect gaps.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S02 final sleep duration, arm-specific changes, between-group sleep effects, CIs, P values, original result tables and supplements are needed. Baseline values do not fill effect gaps." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Is the baseline-adjusted net sleep effect known?", "needed": "Target sleep effect, baseline adjustment and between-group comparison", "role": "Required", "role_reason": "Material on Target sleep effect, baseline adjustment and between-group comparison is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Target sleep effect, baseline adjustment and between-group comparison must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: S02 sleep models, covariates, between-group coefficients, variance, analysis code and sensitivity results are needed. No new adjusted value is calculated. 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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "The stored summary retains baseline imbalance in crying and sleep together with an unclear adjusted net effect.", "condition_status": "Unverified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "S02 sleep models, covariates, between-group coefficients, variance, analysis code and sensitivity results are needed. No new adjusted value is calculated.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S02 sleep models, covariates, between-group coefficients, variance, analysis code and sensitivity results are needed. No new adjusted value is calculated." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What was the prespecified sleep endpoint hierarchy?", "needed": "Prespecified sleep and crying hierarchy, selection and multiplicity", "role": "Required", "role_reason": "Material on Prespecified sleep and crying hierarchy, selection and multiplicity is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Prespecified sleep and crying hierarchy, selection and multiplicity must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Initial registration, protocol, analysis plans, sleep hierarchy, multiple comparisons and endpoint change history are needed. 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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "S02 lists 1-week crying frequency, duration and sleep together. Sleep is not promoted into a new primary endpoint.", "condition_status": "Unverified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "Initial registration, protocol, analysis plans, sleep hierarchy, multiple comparisons and endpoint change history are needed.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Initial registration, protocol, analysis plans, sleep hierarchy, multiple comparisons and endpoint change history are needed." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Does an IRCT number mean registration was read?", "needed": "Registration identifier, timing, original version and change history", "role": "Required", "role_reason": "Material on Registration identifier, timing, original version and change history is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Registration identifier, timing, original version and change history must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: External identity, registration timing, original plans, change records and correspondence with reported results are needed. External registration was unread and access was not attempted here. 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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "The original evidence includes IRCT201106054317N5, while the corresponding bibliography omits it. Distinct original fields and empty values are retained in internal originals.", "condition_status": "Partly verified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "External identity, registration timing, original plans, change records and correspondence with reported results are needed. External registration was unread and access was not attempted here.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "External identity, registration timing, original plans, change records and correspondence with reported results are needed. External registration was unread and access was not attempted here." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Does completion by all 100 infants establish sleep denominators?", "needed": "Overall and arm-specific allocation, completion, sleep analysis and exclusions", "role": "Required", "role_reason": "Material on Overall and arm-specific allocation, completion, sleep analysis and exclusions is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Overall and arm-specific allocation, completion, sleep analysis and exclusions must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Arm-specific flow, sleep analysis denominators, exclusion rules and analysis population tables are needed. 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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "S02's record of 100 infants, all completed, is retained. It is not converted into complete data for every arm, sleep endpoint or diary.", "condition_status": "Partly verified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "Arm-specific flow, sleep analysis denominators, exclusion rules and analysis population tables are needed.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific flow, sleep analysis denominators, exclusion rules and analysis population tables are needed." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Are missing sleep diaries and analysis populations known?", "needed": "Diary missingness, partial records, adherence, ITT and PP", "role": "Required", "role_reason": "Material on Diary missingness, partial records, adherence, ITT and PP is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Diary missingness, partial records, adherence, ITT and PP must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original diaries, missingness tables, imputation, analysis populations, data-quality criteria and sensitivity analyses are needed. 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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "Participant completion and diary completeness are separate. Diary completeness is not linked in the material currently preserved.", "condition_status": "Unverified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "Original diaries, missingness tables, imputation, analysis populations, data-quality criteria and sensitivity analyses are needed.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original diaries, missingness tables, imputation, analysis populations, data-quality criteria and sensitivity analyses are needed." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Are precision and clinical meaning of sleep changes known?", "needed": "Between-group sleep CIs, meaningful differences and sample plans", "role": "Required", "role_reason": "Material on Between-group sleep CIs, meaningful differences and sample plans is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Between-group sleep CIs, meaningful differences and sample plans must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: S02 sleep estimates, CIs, sample plans and evidence for clinical-meaning criteria are needed. No new effect, CI or threshold is created. 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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "The selected note retains reported increase and long-term uncertainty together. Quantitative effects, precision and meaningful differences remain separately unverified.", "condition_status": "Unverified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "S02 sleep estimates, CIs, sample plans and evidence for clinical-meaning criteria are needed. No new effect, CI or threshold is created.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S02 sleep estimates, CIs, sample plans and evidence for clinical-meaning criteria are needed. No new effect, CI or threshold is created." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Is the 48% versus 47% crying result a sleep result?", "needed": "Direct outcome and report attribution for crying versus sleep", "role": "Required", "role_reason": "Material on Direct outcome and report attribution for crying versus sleep is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Direct outcome and report attribution for crying versus sleep must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Report-specific endpoint tables and separate sleep material are needed. General parent wording about two trials is not counted as two confirmatory sleep trials. This records needed materials; no new research was executed.", "current_reports": [ "S01", "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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "S01's 3-week total and colicky crying and 48% versus 47% are crying findings. They are not transferred to sleep; S02's sleep endpoint is distinguished.", "condition_status": "Partly verified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "Report-specific endpoint tables and separate sleep material are needed. General parent wording about two trials is not counted as two confirmatory sleep trials.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-specific endpoint tables and separate sleep material are needed. General parent wording about two trials is not counted as two confirmatory sleep trials." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Do natural improvement and within-group changes establish a massage-specific effect?", "needed": "Time, expectations, active controls and between-group sleep effects", "role": "Required", "role_reason": "Material on Time, expectations, active controls and between-group sleep effects is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Time, expectations, active controls and between-group sleep effects must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: S02 sleep data over time between arms and baseline-adjusted and active-control analyses are needed. This records needed materials; no new research was executed.", "current_reports": [ "S01", "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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "The account emphasizes natural improvement and parent expectations and retains the natural-course interpretation of S01 crying results. This is not repurposed as verification of a net sleep effect.", "condition_status": "Partly verified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "S02 sleep data over time between arms and baseline-adjusted and active-control analyses are needed.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S02 sleep data over time between arms and baseline-adjusted and active-control analyses are needed." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "How do 1-week sleep and 3-week crying scopes differ?", "needed": "Selected sleep period versus the representative parent crying-trial context", "role": "Required", "role_reason": "Material on Selected sleep period versus the representative parent crying-trial context is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Selected sleep period versus the representative parent crying-trial context must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: S02 observation schedules and separate original sleep tables are needed. A 3-week selected sleep effect or net sleep effect versus crib vibration is unlinked. This records needed materials; no new research was executed.", "current_reports": [ "S01", "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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "S02 sleep is measured over 1 week. The parent's 3 weeks, 58 infants, crib vibration and total crying belong to S01 and do not replace sleep analysis.", "condition_status": "Partly verified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "S02 observation schedules and separate original sleep tables are needed. A 3-week selected sleep effect or net sleep effect versus crib vibration is unlinked.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S02 observation schedules and separate original sleep tables are needed. A 3-week selected sleep effect or net sleep effect versus crib vibration is unlinked." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Does short-term sleep improvement persist?", "needed": "Follow-up after 1 week, persistence after delivery ends and development", "role": "Supplementary", "role_reason": "Material on Follow-up after 1 week, persistence after delivery ends and development is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Follow-up after 1 week, persistence after delivery ends and development must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Sleep after 1 week and after massage ends, separate long-term follow-up and safety materials are needed. 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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "The selected note leaves long-term durability uncertain. A short-term report is not extended into long-term improvement.", "condition_status": "Unverified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "Sleep after 1 week and after massage ends, separate long-term follow-up and safety materials are needed.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Sleep after 1 week and after massage ends, separate long-term follow-up and safety materials are needed." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Is reanalysis of the same 100 infants independent replication?", "needed": "Original report, reanalysis and same-cohort links", "role": "Required", "role_reason": "Material on Original report, reanalysis and same-cohort links is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Original report, reanalysis and same-cohort links must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Separate bibliography, original text, cohort links, analysis changes and the target sleep effect are needed. 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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "The account describes a later statistical paper as reanalysis of the same 100 infants. It is not added as a new trial or extra participants.", "condition_status": "Partly verified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "Separate bibliography, original text, cohort links, analysis changes and the target sleep effect are needed.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate bibliography, original text, cohort links, analysis changes and the target sleep effect are needed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are lavender combinations and nurse delivery the same intervention?", "needed": "Caregiver-only massage versus combined oils and professional delivery", "role": "Required", "role_reason": "Material on Caregiver-only massage versus combined oils and professional delivery is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Caregiver-only massage versus combined oils and professional delivery must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Bibliography, intervention composition, sleep results and cohort data for those reports are needed. They do not fill gaps as new direct reports or independent replications. 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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "The original account retains the historical exclusion of lavender combinations and nurse delivery from independent replication of caregiver-only massage.", "condition_status": "Partly verified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "Bibliography, intervention composition, sleep results and cohort data for those reports are needed. They do not fill gaps as new direct reports or independent replications.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Bibliography, intervention composition, sleep results and cohort data for those reports are needed. They do not fill gaps as new direct reports or independent replications." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Can massage results become oil-ingredient effects?", "needed": "Behavioral program, oil use and ingredient controls", "role": "Required", "role_reason": "Material on Behavioral program, oil use and ingredient controls is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Behavioral program, oil use and ingredient controls must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: S02 oil use, type, ingredient controls and original intervention composition are needed. 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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "The account records that trials using oil were not repurposed as oil-ingredient effects.", "condition_status": "Partly verified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "S02 oil use, type, ingredient controls and original intervention composition are needed.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S02 oil use, type, ingredient controls and original intervention composition are needed." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Was the same sleep result independently repeated with other controls?", "needed": "Matching controls, programs, sleep measures and cohorts", "role": "Required", "role_reason": "Material on Matching controls, programs, sleep measures and cohorts is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Matching controls, programs, sleep measures and cohorts must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Separate reports under matching comparison and sleep-measurement conditions, independence and heterogeneity materials are needed. Unique trial and participant totals are not established. This records needed materials; no new research was executed.", "current_reports": [ "S01", "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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "Rocking, crib vibration, kangaroo care and usual care in the account are distinguished. Direct sleep is linked to S02 rocking, while S01 remains crying context.", "condition_status": "Unverified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "Separate reports under matching comparison and sleep-measurement conditions, independence and heterogeneity materials are needed. Unique trial and participant totals are not established.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate reports under matching comparison and sleep-measurement conditions, independence and heterogeneity materials are needed. Unique trial and participant totals are not established." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are concurrent care and the sleep environment known?", "needed": "Feeding, sleep environment, other care, soothing and adherence", "role": "Supplementary", "role_reason": "Material on Feeding, sleep environment, other care, soothing and adherence is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Feeding, sleep environment, other care, soothing and adherence must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: S02 concurrent interventions, feeding, sleep environment, delivery diaries, adherence and analysis plans are needed. 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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "The preserved account distinguishes caregiver massage from different care controls.", "condition_status": "Unverified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "S02 concurrent interventions, feeding, sleep environment, delivery diaries, adherence and analysis plans are needed.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S02 concurrent interventions, feeding, sleep environment, delivery diaries, adherence and analysis plans are needed." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are S01 funding and manufacturer roles known?", "needed": "Original funding, supplies, employee authors and COI material", "role": "Required", "role_reason": "Material on Original funding, supplies, employee authors and COI material is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Original funding, supplies, employee authors and COI material must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original funding, support, affiliations and COI material are needed. Unverified information does not mean no sponsorship, support, employee authors or COI. 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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "S01 remains recorded as specific funding and COI unverified.", "condition_status": "Unverified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "Original funding, support, affiliations and COI material are needed. Unverified information does not mean no sponsorship, support, employee authors or COI.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding, support, affiliations and COI material are needed. Unverified information does not mean no sponsorship, support, employee authors or COI." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Does S02 institutional support establish independence?", "needed": "Institutional acknowledgment, funding, support, affiliations and COI", "role": "Required", "role_reason": "Material on Institutional acknowledgment, funding, support, affiliations and COI is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Institutional acknowledgment, funding, support, affiliations and COI must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original acknowledgments, funding sources, supplies, employee authors, COI and analysis roles are needed. Institutional acknowledgment alone does not establish independence. 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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "S02 retains acknowledged institutional support together with unverified independent funding.", "condition_status": "Partly verified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "Original acknowledgments, funding sources, supplies, employee authors, COI and analysis roles are needed. Institutional acknowledgment alone does not establish independence.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original acknowledgments, funding sources, supplies, employee authors, COI and analysis roles are needed. Institutional acknowledgment alone does not establish independence." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "How were harms actually collected?", "needed": "Adverse-event definitions, collection, arm-specific events, denominators and discontinuation", "role": "Supplementary", "role_reason": "Material on Adverse-event definitions, collection, arm-specific events, denominators and discontinuation is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Adverse-event definitions, collection, arm-specific events, denominators and discontinuation must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: S02 adverse-event forms, active collection, arm-specific safety tables, denominators and discontinuation reasons are needed. No absence of events is filled in. 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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "Parent safety caution and its explanation are preserved. Increased sleep or participant completion is not converted into safety verification.", "condition_status": "Unverified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "S02 adverse-event forms, active collection, arm-specific safety tables, denominators and discontinuation reasons are needed. No absence of events is filled in.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S02 adverse-event forms, active collection, arm-specific safety tables, denominators and discontinuation reasons are needed. No absence of events is filled in." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Can age, development and long-term harms be assessed?", "needed": "Population-specific exposure, vulnerable groups and long-term safety", "role": "Supplementary", "role_reason": "Material on Population-specific exposure, vulnerable groups and long-term safety is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Population-specific exposure, vulnerable groups and long-term safety must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Age- and development-specific harm comparisons and long-term follow-up are needed. Limited short-term data are not extended to overall safety. 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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "Parent cautions about delivery and clinical care are preserved as historical context. The sleep question creates no new safety certification or procedure.", "condition_status": "Unverified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "Age- and development-specific harm comparisons and long-term follow-up are needed. Limited short-term data are not extended to overall safety.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Age- and development-specific harm comparisons and long-term follow-up are needed. Limited short-term data are not extended to overall safety." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Were selected and parent Korean and English values and corrections retained?", "needed": "Original selected and parent wording, grades, axes and change records", "role": "Required", "role_reason": "Material on Original selected and parent wording, grades, axes and change records is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Original selected and parent wording, grades, axes and change records must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original new correction comments and correction events are needed. Historical cross-checks are not inherited as current completed review, fulfilled conditions or a new subclaim score. This records needed materials; no new research was executed.", "current_reports": [ "S01", "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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "Parent Korean and English text, C46 and axes are preserved unchanged. The selected record has C and a note without a separate score. Corrections are an empty array and deliberation an empty string.", "condition_status": "Partly verified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "Original new correction comments and correction events are needed. Historical cross-checks are not inherited as current completed review, fulfilled conditions or a new subclaim score.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original new correction comments and correction events are needed. Historical cross-checks are not inherited as current completed review, fulfilled conditions or a new subclaim score." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "What are the original date and actual reading scope?", "needed": "Historical evidence date, production date, stored summary and unread external materials", "role": "Required", "role_reason": "Material on Historical evidence date, production date, stored summary and unread external materials is needed to connect selected sleep with population, training, rocking, parent diaries, baseline, denominators, precision, durability and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained without inheriting parent C46. Crying values are not transferred to sleep and baseline values are not turned into final values, changes or adjusted effects. Same-cohort reanalyses are not added as new replications; no new effect, CI, denominator total, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Historical evidence date, production date, stored summary and unread external materials must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected sleep from parent crying, historical narratives and unread external material.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing sleep question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: If new material is provided, distinguish identity, original locations, reading scope, evidence date and change events. Historical dates or URLs are not promoted into current external verification. This records needed materials; no new research was executed.", "current_reports": [ "S01", "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 summary, selected sleep record and bibliography read; external papers, registration, protocols, analysis plans, diaries, harms and support materials unread", "observation": "The original date is 2026-09-07. The complete stored parent summary and bibliography were read; external papers, registration, protocols and analysis plans were unread here.", "condition_status": "Partly verified", "status_reason": "This links information and gaps in the preserved sleep and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, a net sleep effect, treatment or safety.", "missingness": "If new material is provided, distinguish identity, original locations, reading scope, evidence date and change events. Historical dates or URLs are not promoted into current external verification.", "uncertainty": "Exact final sleep values, changes, adjusted between-group effects, CIs, P values, valid arm-specific denominators, prespecified hierarchy, contact, durability, harms and independence remain unverified. Baseline values, participant completion and parent crying findings are not converted into new sleep effects, denominators or safety conclusions.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "If new material is provided, distinguish identity, original locations, reading scope, evidence date and change events. Historical dates or URLs are not promoted into current external verification." } ], "reports": [ { "report_id": "S01", "title": "Huhtala V et al. 2000", "url": "https://pubmed.ncbi.nlm.nih.gov/10835097/", "report_type": "Randomized massage-versus-crib-vibration trial; parent crying context distinguished from selected sleep", "existence": "The preserved parent account contains the actual report and bibliography. Current external identity, content, registration and detailed-material verification was not performed.", "acquired_read": "Only the stored parent summary and bibliography were read. External papers, registration, plans, diaries, harms and support materials are unread.", "study_family": "Of the two preserved reports, S02 concerns direct sleep and S01 is parent crying context. Reanalysis of the same 100 infants is not a new cohort; combined oils and professional delivery are not added as independent sleep replication of caregiver massage. Unique trial, participant and independent-replication totals remain unverified.", "independent_replication": "Of the two preserved reports, S02 concerns direct sleep and S01 is parent crying context. Reanalysis of the same 100 infants is not a new cohort; combined oils and professional delivery are not added as independent sleep replication of caregiver massage. Unique trial, participant and independent-replication totals remain unverified.", "observed_result": "The original record states 58 infants, 3-week crying reductions of 48% versus 47%, and no massage-specific benefit. This is not repurposed as the selected sleep effect, denominator or direct replication.", "result_level": "This is a stored summary of parent crying findings. Direct selected sleep results are unlinked, and external originals were unread in this work.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "The preserved bibliography links PMID10835097 and DOI10.1542/peds.105.6.e84. The pre-registration-era absence narrative and unverified specific funding or COI are historical records, not results of current external retrieval or verification. Table dates are historical markers of the original account date. A date does not mean external material was acquired, read or reviewed in this work; the original annotation is retained in internal originals." }, { "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": "The preserved bibliography links PMID10835097 and DOI10.1542/peds.105.6.e84. The pre-registration-era absence narrative and unverified specific funding or COI are historical records, not results of current external retrieval or verification. Table dates are historical markers of the original account date. A date does not mean external material was acquired, read or reviewed in this work; the original annotation is retained in internal originals." }, { "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": "The preserved bibliography links PMID10835097 and DOI10.1542/peds.105.6.e84. The pre-registration-era absence narrative and unverified specific funding or COI are historical records, not results of current external retrieval or verification. Table dates are historical markers of the original account date. A date does not mean external material was acquired, read or reviewed in this work; the original annotation is retained in internal originals." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "The preserved bibliography links PMID10835097 and DOI10.1542/peds.105.6.e84. The pre-registration-era absence narrative and unverified specific funding or COI are historical records, not results of current external retrieval or verification. Table dates are historical markers of the original account date. A date does not mean external material was acquired, read or reviewed in this work; the original annotation is retained in internal originals." }, { "material_type": "Statistical analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "The preserved bibliography links PMID10835097 and DOI10.1542/peds.105.6.e84. The pre-registration-era absence narrative and unverified specific funding or COI are historical records, not results of current external retrieval or verification. Table dates are historical markers of the original account date. A date does not mean external material was acquired, read or reviewed in this work; the original annotation is retained in internal originals." }, { "material_type": "Funding, product support and COI material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "The preserved bibliography links PMID10835097 and DOI10.1542/peds.105.6.e84. The pre-registration-era absence narrative and unverified specific funding or COI are historical records, not results of current external retrieval or verification. Table dates are historical markers of the original account date. A date does not mean external material was acquired, read or reviewed in this work; the original annotation is retained in internal originals." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/10835097/" } ] }, { "report_id": "S02", "title": "Sheidaei A et al. 2016", "url": "https://pubmed.ncbi.nlm.nih.gov/27453882/", "report_type": "Quasi-random referral-day massage-versus-rocking trial; directly linked to parent-diary sleep", "existence": "The preserved parent account contains the actual report and bibliography. Current external identity, content, registration and detailed-material verification was not performed.", "acquired_read": "Only the stored parent summary and bibliography were read. External papers, registration, plans, diaries, harms and support materials are unread.", "study_family": "Of the two preserved reports, S02 concerns direct sleep and S01 is parent crying context. Reanalysis of the same 100 infants is not a new cohort; combined oils and professional delivery are not added as independent sleep replication of caregiver massage. Unique trial, participant and independent-replication totals remain unverified.", "independent_replication": "Of the two preserved reports, S02 concerns direct sleep and S01 is parent crying context. Reanalysis of the same 100 infants is not a new cohort; combined oils and professional delivery are not added as independent sleep replication of caregiver massage. Unique trial, participant and independent-replication totals remain unverified.", "observed_result": "The record states 100 infants, all completed, with a 1-week crying-and-sleep report. Favorable sleep narratives are distinguished from baseline imbalance in sleep, 9.22 versus 12.24 h, and crying, 4.96 versus 3.00 h. Final sleep values, changes and adjusted between-group effects are unlinked.", "result_level": "This is a sleep narrative from a short parent-diary trial. Referral-day allocation, baseline imbalance, parent expectations, contact differences and quantitative gaps are retained. Long-term durability is uncertain, and same-cohort reanalysis is not added as new replication.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "The preserved bibliography's PMID27453882 and PMCID PMC4934450, and original IRCT201106054317N5, are retained. Acknowledged institutional support, unverified independent funding, referral-day allocation and the bibliographic title are distinguished; registration, full text and support content are unread in this work. Table dates are historical markers of the original account date. A date does not mean external material was acquired, read or reviewed in this work; the original annotation is retained in internal originals." }, { "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": "The preserved bibliography's PMID27453882 and PMCID PMC4934450, and original IRCT201106054317N5, are retained. Acknowledged institutional support, unverified independent funding, referral-day allocation and the bibliographic title are distinguished; registration, full text and support content are unread in this work. Table dates are historical markers of the original account date. A date does not mean external material was acquired, read or reviewed in this work; the original annotation is retained in internal originals." }, { "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": "The preserved bibliography's PMID27453882 and PMCID PMC4934450, and original IRCT201106054317N5, are retained. Acknowledged institutional support, unverified independent funding, referral-day allocation and the bibliographic title are distinguished; registration, full text and support content are unread in this work. Table dates are historical markers of the original account date. A date does not mean external material was acquired, read or reviewed in this work; the original annotation is retained in internal originals." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "The preserved bibliography's PMID27453882 and PMCID PMC4934450, and original IRCT201106054317N5, are retained. Acknowledged institutional support, unverified independent funding, referral-day allocation and the bibliographic title are distinguished; registration, full text and support content are unread in this work. Table dates are historical markers of the original account date. A date does not mean external material was acquired, read or reviewed in this work; the original annotation is retained in internal originals." }, { "material_type": "Statistical analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "The preserved bibliography's PMID27453882 and PMCID PMC4934450, and original IRCT201106054317N5, are retained. Acknowledged institutional support, unverified independent funding, referral-day allocation and the bibliographic title are distinguished; registration, full text and support content are unread in this work. Table dates are historical markers of the original account date. A date does not mean external material was acquired, read or reviewed in this work; the original annotation is retained in internal originals." }, { "material_type": "Funding, product support and COI material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "The preserved bibliography's PMID27453882 and PMCID PMC4934450, and original IRCT201106054317N5, are retained. Acknowledged institutional support, unverified independent funding, referral-day allocation and the bibliographic title are distinguished; registration, full text and support content are unread in this work. Table dates are historical markers of the original account date. A date does not mean external material was acquired, read or reviewed in this work; the original annotation is retained in internal originals." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/27453882/" } ] } ], "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": "Of the two preserved reports, S02 concerns direct sleep and S01 is parent crying context. Reanalysis of the same 100 infants is not a new cohort; combined oils and professional delivery are not added as independent sleep replication of caregiver massage. Unique trial, participant and independent-replication totals remain unverified." }, "history": [ { "date": "2026-10-20", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public-facing views and materials were prepared from the existing 30 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-20" }