{ "schema_version": "chamgap-public-criteria-1.0", "title": "Caregiver-delivered infant massage × Increased sleep duration", "language": "en", "translation_date": "2026-10-20", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "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." }, "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." } ] }