{ "schema_version": "chamgap-public-criteria-1.0", "title": "Caregiver-delivered infant massage × Reduced crying in infantile colic", "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": "Which crying-reduction question is being considered?", "needed": "Selected crying question versus the parent's crying and sleep scope", "role": "Required", "role_reason": "Material on Selected crying question versus the parent's crying and sleep scope is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Selected crying question versus the parent's crying and sleep scope must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Selected and parent accounts and change records are needed. Content review of the boundary remains incomplete; this sheet is not counted as a new independent study or question. This records needed materials; no new research was executed." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "How do selected C and parent C46 differ?", "needed": "Selected grade and explanation versus parent score and assessment axes", "role": "Required", "role_reason": "Material on Selected grade and explanation versus parent score and assessment axes is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Selected grade and explanation versus parent score and assessment axes must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: The selection has no separate score, status or assessment axes. Selected and parent values and correction records must be linked without automatically assigning the parent score or completed-review state. This records needed materials; no new research was executed." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Are caregiver massage, combinations and professional delivery the same intervention?", "needed": "Distinction among providers, training, oils and combined interventions", "role": "Required", "role_reason": "Material on Distinction among providers, training, oils and combined interventions is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Distinction among providers, training, oils and combined interventions must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original report-specific training, provider, oil, contact, adherence and concurrent-care specifications are needed. No new massage procedure, intensity, frequency or treatment guidance is created. This records needed materials; no new research was executed." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "How were infants with colic selected and defined?", "needed": "Colic diagnosis, age, baseline crying, inclusion and exclusion", "role": "Required", "role_reason": "Material on Colic diagnosis, age, baseline crying, inclusion and exclusion is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Colic diagnosis, age, baseline crying, inclusion and exclusion must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original diagnostic criteria, age, baseline illness, inclusion, exclusion, other causes of crying and report-specific distributions are needed. Eligibility and baseline tables and assessment materials remain needed. This records needed materials; no new research was executed." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Are crib vibration, rocking and usual care the same comparison?", "needed": "Contact, education, care and direct contrasts by active control", "role": "Required", "role_reason": "Material on Contact, education, care and direct contrasts by active control is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Contact, education, care and direct contrasts by active control must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original comparator-specific contact, time, education, care, expectations, concurrent-exposure specifications and contrast plans are needed. Usual-care signals are not filled with a new report or effect estimate. This records needed materials; no new research was executed." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Could contact, education and care differences mix with the effect?", "needed": "Arm-specific contact, education, caregiver expectations and adherence", "role": "Required", "role_reason": "Material on Arm-specific contact, education, caregiver expectations and adherence is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Arm-specific contact, education, caregiver expectations and adherence must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Actual arm-specific contact, education, adherence, feeding, concurrent care and expectation records are needed. Contributions of accompanying care must be distinguished from massage. This records needed materials; no new research was executed." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are 1-week and 3-week crying results the same effect?", "needed": "Trial-specific recording, exposure, visits and follow-up periods", "role": "Required", "role_reason": "Material on Trial-specific recording, exposure, visits and follow-up periods is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Trial-specific recording, exposure, visits and follow-up periods must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original recording windows, visits, exposure start, post-treatment follow-up and period-specific valid denominators are needed. Short-term observation is distinguished from durability. This records needed materials; no new research was executed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What are crying frequency, duration, total crying and colicky crying?", "needed": "Crying definitions, units, diary aggregation and endpoint hierarchy", "role": "Required", "role_reason": "Material on Crying definitions, units, diary aggregation and endpoint hierarchy is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Crying definitions, units, diary aggregation and endpoint hierarchy must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original diaries, crying definitions, colicky classifications, aggregation, recording windows, prespecified endpoints, denominators and complete result tables are needed. This records needed materials; no new research was executed." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Who recorded crying and knew the intervention?", "needed": "Parent diaries, masking, expectations and missing records", "role": "Required", "role_reason": "Material on Parent diaries, masking, expectations and missing records is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Parent diaries, masking, expectations and missing records must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Recording instruction, timing, adherence, missingness, assessor and aggregation masking, objective comparison records and expectation differences are needed. Diary procedures and measurement bias must be distinguished. This records needed materials; no new research was executed." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Is increased sleep converted into reduced crying or treatment of colic?", "needed": "Selected crying, separate sleep question and colic diagnosis", "role": "Required", "role_reason": "Material on Selected crying, separate sleep question and colic diagnosis is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Selected crying, separate sleep question and colic diagnosis must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Separate crying and sleep results, hierarchy, denominators, measurement intervals and direct links to diagnostic or treatment endpoints are needed. This records needed materials; no new research was executed." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Does a within-group crying decrease establish a massage-specific effect?", "needed": "Natural improvement, baseline, time and between-group comparison", "role": "Required", "role_reason": "Material on Natural improvement, baseline, time and between-group comparison is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Natural improvement, baseline, time and between-group comparison must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original within- and between-group results, baseline, time, comparators and analysis are needed. Contributions of natural improvement, contact and expectations, adjusted net effects and period-specific denominators remain unverified. This records needed materials; no new research was executed." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "What does the 58-infant, 3-week crib-vibration trial show?", "needed": "58 infants, 3 weeks, 48% versus 47% and active-control results", "role": "Required", "role_reason": "Material on 58 infants, 3 weeks, 48% versus 47% and active-control results is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on 58 infants, 3 weeks, 48% versus 47% and active-control results must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original arm-specific allocation, analysis, baseline, endpoints, denominators, exact reduction definitions, adjusted contrasts and CIs are needed. No new difference between percentages, effect or treatment rate is calculated. This records needed materials; no new research was executed." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "What analysis denominator does 58 infants represent?", "needed": "Total and arm-specific allocation, analysis and diary- or endpoint-specific denominators", "role": "Required", "role_reason": "Material on Total and arm-specific allocation, analysis and diary- or endpoint-specific denominators is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Total and arm-specific allocation, analysis and diary- or endpoint-specific denominators must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original flow diagrams, valid denominators by arm, endpoint and diary, attrition, exclusions and person or record units are needed. This records needed materials; no new research was executed." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "What are the results of the 100-infant, 1-week rocking comparison?", "needed": "Referral-day allocation, baseline imbalance and adjusted net effect", "role": "Required", "role_reason": "Material on Referral-day allocation, baseline imbalance and adjusted net effect is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Referral-day allocation, baseline imbalance and adjusted net effect must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original adjusted between-group crying effects, CIs, P, analysis populations, contact, time, baseline, prespecified hierarchy and complete tables are needed. The bibliographic title and allocation limitations are retained together. This records needed materials; no new research was executed." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "What do baseline 4.96 versus 3.00 h represent?", "needed": "Baseline crying versus end-point values, change and adjusted effects", "role": "Required", "role_reason": "Material on Baseline crying versus end-point values, change and adjusted effects is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Baseline crying versus end-point values, change and adjusted effects must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original arm-specific baseline and end-point results, denominators, variance, CIs and adjustment models are needed. No new time difference, effect size or adjusted value is calculated. This records needed materials; no new research was executed." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Are 9.22 versus 12.24 h the selected crying effect?", "needed": "Baseline sleep and separate crying and sleep analyses", "role": "Required", "role_reason": "Material on Baseline sleep and separate crying and sleep analyses is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Baseline sleep and separate crying and sleep analyses must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original sleep and crying tables, baseline adjustment, analysis plans, denominators, correlations and exact final or between-group effects are needed. This records needed materials; no new research was executed." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "What limitations does referral-day allocation leave?", "needed": "Allocation, concealment, visit sequence and baseline balance", "role": "Required", "role_reason": "Material on Allocation, concealment, visit sequence and baseline balance is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Allocation, concealment, visit sequence and baseline balance must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original visit and allocation rules, concealment, recruitment, exclusions, baseline and follow-up adjustment and selection differences are needed. No new formal bias assessment or bias-magnitude calculation is performed. This records needed materials; no new research was executed." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Does completion by all 100 infants mean every record is complete?", "needed": "Completion versus diary-, arm- and endpoint-specific validity", "role": "Required", "role_reason": "Material on Completion versus diary-, arm- and endpoint-specific validity is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Completion versus diary-, arm- and endpoint-specific validity must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original flow diagrams, valid arm-, diary- and endpoint-specific denominators, missing records, exclusions, adjustments and harm-collection material are needed. This records needed materials; no new research was executed." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "How are within-group, between-group, end-point and adjusted results distinguished?", "needed": "Analysis population, effect of interest, model and direct contrast", "role": "Required", "role_reason": "Material on Analysis population, effect of interest, model and direct contrast is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Analysis population, effect of interest, model and direct contrast must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original analysis plans, ITT, PP, contrasts, models, baseline adjustment, period and diary averages, exact estimates, CIs and complete tables are needed. This records needed materials; no new research was executed." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Were crying endpoints and analyses prespecified?", "needed": "Registration, protocols, analysis plans and crying or sleep hierarchy", "role": "Required", "role_reason": "Material on Registration, protocols, analysis plans and crying or sleep hierarchy is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Registration, protocols, analysis plans and crying or sleep hierarchy must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original registration history, protocols, analysis plans, primary and secondary hierarchy, recording windows, multiplicity and timing of plan changes are needed. This records needed materials; no new research was executed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "What information do the pre-registration narrative and IRCT identifier provide?", "needed": "Historical registration narrative and identifier versus actual content verification", "role": "Required", "role_reason": "Material on Historical registration narrative and identifier versus actual content verification is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Historical registration narrative and identifier versus actual content verification must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Actual original registration, protocols, history and links to reports and plans are needed. Historical wording is not converted into a new search conclusion, or IRCT into certification under another registry system. This records needed materials; no new research was executed." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are differing active-control results retained together?", "needed": "No benefit versus crib vibration versus a signal against rocking", "role": "Required", "role_reason": "Material on No benefit versus crib vibration versus a signal against rocking is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on No benefit versus crib vibration versus a signal against rocking must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Complete original results, control conditions, adjusted effects, CIs, inclusion and exclusion lists and direct usual-care materials are needed for each comparison. This records needed materials; no new research was executed." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Is the later statistical paper independent replication?", "needed": "Reanalysis of the same 100 infants versus report and cohort links", "role": "Required", "role_reason": "Material on Reanalysis of the same 100 infants versus report and cohort links is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Reanalysis of the same 100 infants versus report and cohort links must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Exact bibliographies for the main report and reanalysis, original analyses, recruitment, registration, cohort links and whether new data were used are needed. The same participants are not added twice. This records needed materials; no new research was executed." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are lavender combinations and nurse delivery counted as the same intervention?", "needed": "Caregiver massage alone versus combined oils and professional delivery", "role": "Required", "role_reason": "Material on Caregiver massage alone versus combined oils and professional delivery is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Caregiver massage alone versus combined oils and professional delivery must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Existing originals, intervention specifications, denominators, components, providers, contributions of massage and ingredients and applicability materials are needed. This records needed materials; no new research was executed." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are the same reports counted repeatedly across crying, parent and sleep questions?", "needed": "Shared reports, endpoints, related cohorts and unique counts", "role": "Required", "role_reason": "Material on Shared reports, endpoints, related cohorts and unique counts is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Shared reports, endpoints, related cohorts and unique counts must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Links among original registration, recruitment, reports, reanalyses, cohorts, endpoints and denominators are needed. Unique trial, participant and independent-replication totals remain unverified. This records needed materials; no new research was executed." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are the CI and clinical importance of crying reduction known?", "needed": "Adjusted contrast, precision and differences important to families", "role": "Required", "role_reason": "Material on Adjusted contrast, precision and differences important to families is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Adjusted contrast, precision and differences important to families must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original adjusted effects, CIs, denominators, variance, clinical thresholds and family-specific importance for selected crying are needed. No new effect, interval, importance threshold or individual effect is calculated. This records needed materials; no new research was executed." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "How are 1-week and 3-week results and different controls or delivery conditions distinguished?", "needed": "Duration, active control, contact, baseline, measurement and intervention", "role": "Required", "role_reason": "Material on Duration, active control, contact, baseline, measurement and intervention is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Duration, active control, contact, baseline, measurement and intervention must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Condition-specific original results, eligibility, baseline, exposure, plans and direct differences by period, control or provider, heterogeneity, subgroups and inclusion lists are needed. This records needed materials; no new research was executed." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Does short-term crying reduction establish durability or cure?", "needed": "Short observation versus post-treatment follow-up and resolution of colic", "role": "Required", "role_reason": "Material on Short observation versus post-treatment follow-up and resolution of colic is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Short observation versus post-treatment follow-up and resolution of colic must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original post-treatment follow-up, crying after stopping, colic diagnosis or resolution, development, clinical events, between-group results and denominators are needed. This records needed materials; no new research was executed." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "How much is known about funding, COI and institutional support?", "needed": "Specific funding, support, COI and analysis or publication roles", "role": "Required", "role_reason": "Material on Specific funding, support, COI and analysis or publication roles is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Specific funding, support, COI and analysis or publication roles must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original funding, COI, contracts, institution and author roles, and involvement in education, products, analysis and publication are needed. Support narratives are not converted into detailed certification of independence. This records needed materials; no new research was executed." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "What materials were actually read in this work?", "needed": "Stored complete parent summary and selected question versus external materials", "role": "Required", "role_reason": "Material on Stored complete parent summary and selected question versus external materials is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Stored complete parent summary and selected question versus external materials must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: External identity, content, original diaries, registration, prespecified plans and actual availability or acquisition materials are needed. Summary reading is distinguished from reading external originals. This records needed materials; no new research was executed." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "What is the scope of the original evidence date and historical cross-check?", "needed": "Original account date, empty correction history and production time", "role": "Required", "role_reason": "Material on Original account date, empty correction history and production time is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Original account date, empty correction history and production time must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Records of historical access and reading locations and times, search scope, current external material and correction events are needed. Production time does not become an evidence-verification date. This records needed materials; no new research was executed." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "How are selected Korean and English wording and parent explanations preserved?", "needed": "Selected claim, grade and explanation versus parent crying and sleep scope", "role": "Required", "role_reason": "Material on Selected claim, grade and explanation versus parent crying and sleep scope is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Selected claim, grade and explanation versus parent crying and sleep scope must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Selected and parent originals and correction records are needed. External detailed translation comparison and content review remain incomplete; no new selected score, status or use or treatment guidance is created. This records needed materials; no new research was executed." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Do parent assessment axes establish completed review of the selected question?", "needed": "Parent axes, false-valued markers and empty values versus selected fields", "role": "Required", "role_reason": "Material on Parent axes, false-valued markers and empty values versus selected fields is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Parent axes, false-valued markers and empty values versus selected fields must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original selected and parent assessments and correction records must be linked. No new formal assessment, grade, independence certification or external content review of the selection was performed. This records needed materials; no new research was executed." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "How were harms collected?", "needed": "Harm-event definitions, severity, collection methods and exposure", "role": "Required", "role_reason": "Material on Harm-event definitions, severity, collection methods and exposure is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Harm-event definitions, severity, collection methods and exposure must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original harm tables, event types, active or spontaneous collection, severity, diagnosis, arm-specific counts, exposure, missingness and reporting scope are needed. This records needed materials; no new research was executed." }, { "item_id": "N35", "question_type": "Evidence condition", "question": "Are exposure, event, stopping and recovery timelines known?", "needed": "Harm onset and recovery versus exposure and observation timing", "role": "Required", "role_reason": "Material on Harm onset and recovery versus exposure and observation timing is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Harm onset and recovery versus exposure and observation timing must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Existing event, exposure, follow-up, stopping, recovery, latency and actual timeline materials are needed. Unknown events are not filled in. This records needed materials; no new research was executed." }, { "item_id": "N36", "question_type": "Evidence condition", "question": "Can harm frequency or comparative risk be stated?", "needed": "Arm-specific exposure, affected people, event counts, time and denominators", "role": "Required", "role_reason": "Material on Arm-specific exposure, affected people, event counts, time and denominators is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Arm-specific exposure, affected people, event counts, time and denominators must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original arm-specific harms, exposure, affected people, event counts, time, duplicates, denominators, direct comparisons and CIs are needed. This records needed materials; no new research was executed." }, { "item_id": "N37", "question_type": "Evidence condition", "question": "Are other crying causes and baseline states distinguished from effects and harms?", "needed": "Colic, other conditions, concurrent care and alternative explanations", "role": "Required", "role_reason": "Material on Colic, other conditions, concurrent care and alternative explanations is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Colic, other conditions, concurrent care and alternative explanations must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original eligibility, baseline illnesses, diagnosis, concurrent exposures, care, alternative event explanations and adjustment materials are needed. This records needed materials; no new research was executed." }, { "item_id": "N38", "question_type": "Evidence condition", "question": "Are harms in the same report or reanalysis counted as independent events?", "needed": "Affected people and events versus reanalysis, recitation and report relationships", "role": "Required", "role_reason": "Material on Affected people and events versus reanalysis, recitation and report relationships is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Affected people and events versus reanalysis, recitation and report relationships must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Existing events, original reports, related reanalyses, recitations, family links, unique event counts and duplication materials are needed. This records needed materials; no new research was executed." }, { "item_id": "N39", "question_type": "Evidence condition", "question": "Do short-term data answer long-term or rare-harm questions?", "needed": "Observation periods, population-specific baseline states and long-term or rare events", "role": "Required", "role_reason": "Material on Observation periods, population-specific baseline states and long-term or rare events is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Observation periods, population-specific baseline states and long-term or rare events must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Existing long-term or rare events, special populations, vulnerability, exposure, concurrent care and safety follow-up materials are needed. This records needed materials; no new research was executed." }, { "item_id": "N40", "question_type": "Evidence condition", "question": "How far do signals, no difference and uncertainty extend?", "needed": "Active controls, parent diaries, natural history and net effect", "role": "Required", "role_reason": "Material on Active controls, parent diaries, natural history and net effect is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Active controls, parent diaries, natural history and net effect must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original results, prespecified plans, direct adjusted effects, CIs, objective records, long-term data, harms, independence links and correction materials are needed. This records needed materials; no new research was executed." }, { "item_id": "N41", "question_type": "Evidence condition", "question": "Do methodological links mean content review is complete?", "needed": "5 preserved methodological sources versus criterion design and content review", "role": "Required", "role_reason": "Material on 5 preserved methodological sources versus criterion design and content review is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on 5 preserved methodological sources versus criterion design and content review must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Review of individual methods and external content, with relevant existing materials, remains needed. Criterion design and observation writing are distinguished from completed content review. This records needed materials; no new research was executed." }, { "item_id": "N42", "question_type": "Evidence condition", "question": "What materials would update the crying evidence gaps?", "needed": "Arm and diary denominators, adjusted effects, CIs, plans and report relationships", "role": "Required", "role_reason": "Material on Arm and diary denominators, adjusted effects, CIs, plans and report relationships is needed to connect the selected crying question with population, provider, comparator, period, baseline, diaries, denominators, precision and harms.", "application_exception": "Selected C and the absence of individual score, status and axes are retained without inheriting parent C46. Different comparators, periods, parent diaries, natural history, baseline imbalance, reanalyses and shared reports are distinguished. No new effect, CI, denominator total, independence count, grade, procedure, individual diagnosis or treatment guidance is created.", "criterion": "Original material on Arm and diary denominators, adjusted effects, CIs, plans and report relationships must link to the relevant report, comparator, period, measures, baseline, denominators and analysis, distinguishing selected crying, parent sleep context, 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 selected question. They do not establish preregistration, use of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original diaries, results, registration, analysis plans, contact, baseline, shared cohorts, long-term data, harms and correction records are needed. The prior original must be preserved and criterion revisions distinguished from material additions. This records needed materials; no new research was executed." } ] }