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["Basic information",null,null,null,null,null,null,null,null,null,null,null,null,"Domain 1. Randomization process",null,null,null,null,null,null,null,null,null,"Domain 2. Deviations from intended interventions",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Domain 3. Missing outcome data",null,null,null,null,null,null,null,null,null,null,null,null,"Domain 4. Measurement of the outcome",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Domain 5. Selection of the reported result",null,null,null,null,null,null,null,null,null,null,"Domain 6. Overall Bias"]
["Time","Unique ID","Assessor","Study ID","Reference","Experimental","Comparator","Outcome","Results","Aim","Effect of adhering to intervention?","Weight","Sources","1.1","1.2","Note for 1.1&1.2","1.3","Note for 1.3","1.0 Algorithm result","1.0 Assessor's Judgement","1.0 General note","1.0 Optional Question","1.0 Note for optional question","2.1","2.2","Note for 2.1&2.2","2.3","Note for 2.3","2.4","Note for 2.4","2.5","Note for 2.5","2.6","Note for 2.6","2.7","Note for 2.7","2.0 Algorithm result","2.0 Assessor's Judgement","2.0 General Notes","2.0 Optional Question","2.0 Note for optional question","3.1","Note for 3.1","3.2","Note for 3.2","3.3","Note for 3.3&3.4","3.4","Note for 3.4 (not use)","3.0 Algorithm result","3.0 Assessor's judgement","3.0 General notes","3.0 Optional Question","3.0 Note for optional question","4.1","Note for 4.1","4.2","Note for 4.2","4.3","Note for 4.3","4.4","Note for 4.4&4.5","4.5","Note for 4.5 (not use)","4.0 Algorithm result","4.0 Assessor's Judgement","4.0 General note","4.0 Optional Question","4.0 Note for optional question","5.1","Note for 5.1","5.2","Note for 5.2","5.3","Note for 5.3","5.0 Algorithm result","5.0 Assessor's Judgement","5.0 General note","5.0 Optional Question","5.0 Note for optional question","Algorithm's overall Judgement","Assessor's overall Judgement","6.0 General Note","6.0 Optional Question","6.0 Note for optional question"]
["2021/08/31 16.57","CRO2006D1","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Death after randomisation","\"Death\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \rNo marked imbalance of baseline characteristics. \n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y",">85% of those randomised had data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low",">85% of those randomised had data for this outcome. ",null,null,"N",null,"N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","\r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"Y","Prospective statistical analysis plan included in protocol. ","N",null,"N",null,"Low","Low","Prospective statistical analysis plan included in protocol.\r\n\r\n",null,null,"Low","Low",">85% of those randomised had data for this outcome. \r\n\r\n\r\n"]
["2022/01/11 10.17","CRO2006D2","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Neurocognitive impairment at age 6 to <18 years","Neurosensory disability: mild +mod+ severe","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\nNo marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"PN","78% of those randomised had assessments of this outcome. Outcome occurred in 16-17%.","PN","No sensitivity analysis. ","PY","Similar levels of missing data in both intervention and placebo group. ","PN",null,"Some concerns","Some concerns","78% of those randomised had assessments of this outcome. Outcome occurred in 16-17%. No sensitivity analysis for missing data. Similar levels of missing data in both intervention and placebo group.  ",null,null,"N","Outcome measurement performed by a pediatrician and psychologist unaware of allocation. ","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Outcome measurement performed by a pediatrician and psychologist unaware of allocation. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"Y","Prospective statistical analysis plan included in protocol. ","N","Outcome predefined. ","N",null,"Low","Low","Prospective data analysis plan included in protocol. ",null,null,"Some concerns","Some concerns","78% of those randomised had assessments of this outcome. Outcome occurred in 16-17%.\r\nNo sensitivity analysis. Similar levels of missing data in both intervention and placebo group. \r\n"]
["2022/01/11 10.18","CRO2006D3","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Survival free of neurocognitive impairment at age 6 to <18 ","\"survival free of disability \"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\nNo marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"PN","78% of those randomised had data for this outcome. ","N","No sensitivity analysis for missing data. ","PY","Loss to follow up was similar in both intervention and placebo groups. ","PN",null,"Some concerns","Some concerns","78% of those randomised had data for this outcome. \r\nNo sensitivity analysis for missing data. \r\nLoss to follow up was similar in both intervention and placebo groups. \r\n",null,null,"N","Outcome measurement performed by a pediatrician and psychologist unaware of allocation. ","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Outcome measurement performed by a pediatrician and psychologist unaware of allocation. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"Y","Prospective statistical analysis plan included in protocol. ","N","Outcome was predefined. ","N",null,"Low","Low","Prospective statistical analysis plan included in protocol. \r\n",null,null,"Some concerns","Some concerns","78% of those randomised had assessments of this outcome. Loss to follow up was similar in both intervention and placebo groups. "]
["2022/01/11 10.18","CRO2006D4","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Survival free of major neurocognitive impairment at age 6 to <18 years ","\"neurosensory disability: total n minus severe\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\nNo marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"PN","78% of those randomised had data for this outcome. ","N","No sensitivity analysis for missing data. ","PY","Loss to follow up was similar in both intervention and placebo groups. ","PN",null,"Some concerns","Some concerns","78% of those randomised had data for this outcome. \r\nNo sensitivity analysis for missing data. \r\nLoss to follow up was similar in both intervention and placebo groups. \r\n",null,null,"N","Outcome measurement performed by a pediatrician and psychologist unaware of allocation. ","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","\r\nOutcome measurement performed by a pediatrician and psychologist unaware of allocation. \r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"Y","Prospective statistical analysis plan included in protocol. ","N","Outcome was predefined.","N",null,"Low","Low","Prospective data analysis plan included in protocol.",null,null,"Some concerns","Some concerns","78% of those randomised had assessments of this outcome. Loss to follow up was similar in both intervention and placebo groups. "]
["2022/01/11 10.19","CRO2006D6","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Cognitive impairment at age 6 to <18 years, quantified as nil, mild, moderate or severe","IQ mean and SD, quantified by IQ<55, 55-70, 70-85 and >85. ","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\nNo marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"PN","78% of those randomised had data for this outcome. ","N","No sensitivity analysis for missing data. ","PY","Loss to follow up was similar in both intervention and placebo groups. ","PN",null,"Some concerns","Some concerns","78% of those randomised had data for this outcome. \r\nNo sensitivity analysis for missing data. \r\nLoss to follow up was similar in both intervention and placebo groups. \r\n",null,null,"N","Outcome measurement performed by a psychologist unaware of allocation. ","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Outcome measurement performed by a psychologist unaware of allocation. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"Y","Prospective statistical analysis plan included in protocol. ","N","Predefined outcome. ","N",null,"Low","Low","Prospective statistical analysis plan included in protocol. \r\n",null,null,"Some concerns","Some concerns","78% of those randomised had data for this outcome. Loss to follow up was similar in both intervention and placebo groups. "]
["2022/01/11 10.25","CRO2006D7","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Educational achievement ","Wide range achievement test scores in reading, spelling, mathematics using SMD","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\nNo marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"PN","74% of those randomised had data for this outcome. ","N","No sensitivity analysis for missing data. ","PY","Similar proportions of missing data were seen in intervention and placebo groups. ","PN",null,"Some concerns","Some concerns","74% of those randomised had data for this outcome. \r\nNo sensitivity analysis for missing data. \r\nSimilar proportions of missing data were seen in intervention and placebo groups. \r\n",null,null,"N","Test completed by child.","PN",null,"N","Children were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Test completed by child.\r\n\r\nChildren were blinded to allocation. \r\n\r\n",null,null,"Y","Prospective statistical analysis plan included in protocol. ","N","Prespecified outcome measure. ","N",null,"Low","Low","Prospective data analysis plan included in protocol.\r\n",null,null,"Some concerns","Some concerns","74% of those randomised had data for this outcome. Similar proportions of missing data were seen in intervention and placebo groups. \r\n"]
["2022/01/11 10.24","CRO2006D8","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Cerebral palsy ","Cerebral palsy","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\nNo marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"PY",">85% of those randomised had data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low",">85% of those randomised had data for this outcome. ",null,null,"N","Outcome measurement performed by a pediatrician unaware of allocation. ","PN",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Outcome measurement performed by a pediatrician unaware of allocation. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"Y","Prospective statistical analysis plan included in protocol. ","N","Outcome prespecified. Different categories of mild, moderate and severe were not listed separately, likely because overall numbers with cerebral palsy were small. ","N",null,"Low","Low","Prospective statistical analysis plan included in protocol. \r\n",null,null,"Low","Low",">85% of those randomised had data for this outcome. "]
["2022/01/11 10.27","CRO2006I2","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","blindness/visual impairment ","\"blind\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\nNo marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"PN","78% of those randomised had data for this outcome. ","N","No sensitivity analysis for missing data. ","PY","Proportion of missing data similar in intervention and placebo groups. \r\n","PN",null,"Some concerns","Some concerns","78% of those randomised had data for this outcome. \r\nNo sensitivity analysis for missing data. \r\nProportion of missing data similar in intervention and placebo groups. \r\n\r\n",null,null,"N","Outcome assessed by a pediatrician blinded to allocation. ","PN",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Outcome assessed by a pediatrician blinded to allocation. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"Y","Prospective statistical analysis plan included in protocol. ","N","Predefined outcome. ","N",null,"Low","Low","Prospective statistical analysis plan included in protocol. \r\n",null,null,"Some concerns","Some concerns","78% of those randomised had data for this outcome. \r\nProportion of missing data similar in intervention and placebo groups. \r\n"]
["2022/01/11 10.28","CRO2006I3","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","deafness","\"deaf\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\nNo marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"PN","78% of those randomised had data for this outcome. ","N","No sensitivity analysis for missing data. ","PY","Proportion of missing data similar in intervention and placebo groups. ","PN",null,"Some concerns","Some concerns","78% of those randomised had data for this outcome. \r\nNo sensitivity analysis for missing data. \r\nProportion of missing data similar in intervention and placebo groups. \r\n",null,null,"N","Outcome assessed by a pediatrician blinded to allocation. ","PN",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Outcome assessed by a pediatrician blinded to allocation. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"Y","Prospective statistical analysis plan included in protocol. ","N","Predefined outcome. ","N",null,"Low","Low","Prospective statistical analysis plan included in protocol. \r\n",null,null,"Some concerns","Some concerns","78% of those randomised had data for this outcome. \r\nProportion of missing data similar in intervention and placebo groups. \r\n"]
["2022/01/11 10.29","CRO2006I4I","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","child behaviour","\"SDQ total difficulties parent\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\nNo marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"PN","75% of those randomised had data for this outcome. ","N","No sensitivity analysis for missing data. ","PY","Proportion of missing data similar in intervention and placebo groups. ","PN",null,"Some concerns","Some concerns","75% of those randomised had data for this outcome. \r\nNo sensitivity analysis for missing data. \r\nProportion of missing data similar in intervention and placebo groups. \r\n",null,null,"N",null,"PN","Outcome assessed by a parent/caregiver blinded to allocation. ","N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","\r\nOutcome assessed by a parent/caregiver blinded to allocation. \r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"Y","Prospective statistical analysis plan included in protocol. ","N","Predefined outcome. ","N",null,"Low","Low","Prospective statistical analysis plan included in protocol. \r\n",null,null,"Some concerns","Some concerns","75% of those randomised had data for this outcome. Proportion of missing data similar in intervention and placebo groups. "]
["2022/01/11 10.29","CRO2006I4II","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","child behaviour","\"SDQ total difficulties teacher\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\nNo marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"N","61% of those randomised had data for this outcome. ","N","No sensitivity analysis. ","PY","Those without a teacher assessment may be more likely to have difficulties with behaviour but the proportion of missing data was similar in intervention and placebo groups. ","PN",null,"Some concerns","Some concerns","61% of those randomised had data for this outcome. Proportion of missing data was similar in intervention and placebo groups. ",null,null,"N","Outcome assessed by a teacher unaware of allocation. ","PN",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","\r\nOutcome assessed by a teacher unaware of allocation. \r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"Y","Prospective statistical analysis plan included in protocol. ","N","Predefined outcome. ","N",null,"Low","Low","Prospective data analysis plan included in protocol (supplemental data). \r\n",null,null,"Some concerns","Some concerns","61% of those randomised had data for this outcome. Proportion of missing data similar in intervention and placebo groups. "]
["2022/01/11 10.32","CRO2006I5","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Asthma or recurrent wheeze","\"asthma ever\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\nNo marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y",">85% of those randomised had data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low",">85% of those randomised had data for this outcome. ",null,null,"PN","Medical history collected as part of an assessment by a paediatrician","PN",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Medical history collected as part of an assessment by a paediatrician\r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"Y","Prospective statistical analysis plan included in protocol. ","N","Predefined outcome. ","N",null,"Low","Low","Prospective statistical analysis plan included in protocol. \r\n",null,null,"Low","Low","Low risk of bias for all domains\r\n\r\n"]
["2021/10/11 10.10","CRO2006I6","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Respiratory disease ","“admission for respiratory illness”","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \rNo marked imbalance of baseline characteristics. \n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y",">85% of those randomised had data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low",">85% of those randomised had data for this outcome. ",null,null,"PN","hospital readmission was assessed via questionnaire at 2 years of age also and the results at 6-8 years are much lower, suggesting that this outcome is unreliable over longer time periods as it is reliant on parental memory of admissions and reasons for admission. ","PN",null,"NA","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"High","High","Although outcome assessors were blinded to allocation,  parental recall of reasons for hospital admissions may be unreliable. ",null,null,"Y","Prospective statistical analysis plan included in protocol. ","N","Predefined outcome. ","N",null,"Low","Low","Prospective statistical analysis plan included in protocol. \r\n",null,null,"High","High","Although outcome assessors were blinded to allocation, parental recall of reasons for hospital admissions may be unreliable as number of respiratory admissions total was lower than when assessed at 2 years.  \r\n"]
["2021/10/11 10.13","CRO2006K1II","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Hospital re-admission at childhood follow-up at 6-8years","\"any hospital readmission\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \rNo marked imbalance of baseline characteristics. \n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y",">85% of those randomised had data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low",">85% of those randomised had data for this outcome. ",null,null,"PN","hospital readmission was assessed via questionnaire at 2 years of age also and the results at 6-8 years are much lower, suggesting that this outcome is unreliable over longer time periods as it is reliant on parental memory of admissions to hospital. ","PN",null,"NA","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"High","High","Although outcome assessors were blinded to allocation,  parental recall of reasons for hospital admissions may be unreliable. ",null,null,"Y","Prospective statistical analysis plan included in protocol. ","N","Predefined outcome. ","N",null,"Low","Low","Prospective statistical analysis plan included in protocol. \r\n",null,null,"High","High","Although outcome assessors were blinded to allocation, parental recall of reasons for hospital admissions may be unreliable as number of readmissions total was lower than when assessed at 2 years.  \r\n"]
["2021/10/11 10.14","CRO2006O1I","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Weight aged 6-8","\"weight and weight z scores\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \rNo marked imbalance of baseline characteristics. \n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","82% of those randomised had data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","82% of those randomised had data for this outcome. ",null,null,"N",null,"PN","Outcome measurement performed by a pediatrician unaware of allocation. ","N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Outcome assessors were blinded to allocation. \r\n\r\n",null,null,"Y","Prospective statistical analysis plan included in protocol. ","N","Predefined outcome","N",null,"Low","Low","Prospective statistical analysis plan included in protocol. \r\n\r\n",null,null,"Low","Low","82% of those randomised had data for this outcome. "]
["2021/10/11 10.15","CRO2006O1II","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","head circumference age 6-8","\"HC and HC z scores\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \rNo marked imbalance of baseline characteristics. \n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"PN","77% of those randomised had data for this outcome","PN","No sensitivity analysis for missing data. ","PN","similar levels of loss to follow up in each group.","NA",null,"Some concerns","Some concerns","77% of those randomised had data for this outcome\r\nNo sensitivity analysis for missing data. \r\nsimilar levels of loss to follow up in each group.\r\n",null,null,"N",null,"PN","Outcome measurement performed by a pediatrician unaware of allocation. ","N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Outcome assessors were blinded to allocation. \r\n\r\n",null,null,"Y","Prospective statistical analysis plan included in protocol. ","N","Predefined outcome","N",null,"Low","Low","Prospective statistical analysis plan included in protocol. \r\n",null,null,"Some concerns","Some concerns","77% of those randomised had data for this outcome. Similar levels of loss to follow up in intervention and placebo group. "]
["2021/10/11 10.16","CRO2006O1III","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Height aged 6-8","\"height and height z scores\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \rNo marked imbalance of baseline characteristics. \n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","80% of those randomised had data ","NA",null,"NA",null,"NA",null,"Low","Low","80% of those randomised had data. Similar levels of loss to follow up in intervention and placebo group. \r\n\r\n\r\n",null,null,"N",null,"PN","Outcome measurement performed by a pediatrician unaware of allocation. ","N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"Y","Prospective statistical analysis plan included in protocol. ","N","Predefined outcome","N",null,"Low","Low","Prospective statistical analysis plan included in protocol. \r\n",null,null,"Low","Low","80% of those randomised had data. Similar levels of loss to follow up in intervention and placebo group. "]
["2021/10/11 10.16","CRO2006O2","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","BMI aged 6-8","\"BMI and BMI z scores\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \rNo marked imbalance of baseline characteristics. \n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","80% of those randomised had data ","NA",null,"NA",null,"NA",null,"Low","Low","80% of those randomised had data. Similar levels of loss to follow up in intervention and placebo group. \r\n\r\n\r\n",null,null,"N",null,"PN","Outcome measurement performed by a pediatrician unaware of allocation. ","N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"Y","Prospective statistical analysis plan included in protocol. ","N","Predefined outcome","N",null,"Low","Low","Prospective statistical analysis plan included in protocol. \r\n",null,null,"Low","Low","80% of those randomised had data. Similar levels of loss to follow up in intervention and placebo group. "]
["2022/01/11 10.45","CRO2006O4","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Lean body mass","mean fat free mass adjusted for height","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\nNo marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"N","185/212 (87%) children living in centre with DEXA available were assess","N",null,"PY","Levels of missing data were similar between groups. Most were missing because they were unable to be traced or declined follow up and because DEXA was only available in 2 centres for logistical reasons. 8 were excluded because of severe disability. ","PN",null,"Some concerns","Some concerns","185/212 (87%) children living in centre with DEXA available were assessed. Most that were missing were unable to be traced or declined follow up or were at a centre without DEXA availability. 8 were excluded because of severe disability. \r\n",null,null,"N","Measured using whole body dual energy x ray absorptiometry","PN",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Measured using whole body dual energy x ray absorptiometry\r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","Data analysis plan included in methods. Other follow up studies of the trial had prespecified statistical analysis plans.  ","PN",null,"PN",null,"Low","Low","Data analysis plan included in methods. Other follow up studies of the trial had prespecified statistical analysis plans.  \r\n\r\n",null,null,"Some concerns","Some concerns","185/212 (87%) children living in centres with DEXA available were assessed but this was already a subgroup of the overall study. "]
["2022/01/11 10.45","CRO2006O5","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","fat mass","mean fat mass adjusted for height","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\nNo marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"N","185/212 (87%) children living in centre with DEXA available were assess","N",null,"PY","Levels of missing data were similar between groups. Most were missing because they were unable to be traced or declined follow up and because DEXA was only available in 2 centres for logistical reasons. 8 were excluded because of severe disability. ","PN",null,"Some concerns","Some concerns","185/212 (87%) children living in centres with DEXA available were assessed. Most that were missing were unable to be traced or declined follow up or were at a centre without DEXA availability. 8 were excluded because of severe disability. ",null,null,"N","Measured using whole body dual energy x ray absorptiometry","PN",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Measured using whole body dual energy x ray absorptiometry\r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","Data analysis plan included in methods. Other follow up studies of the trial had prespecified statistical analysis plans.  ","PN",null,"PN",null,"Low","Low","Data analysis plan included in methods. Other follow up studies of the trial had prespecified statistical analysis plans.  ",null,null,"Some concerns","Some concerns","185/212 (87%) children living in centres with DEXA available were assessed but this was already a subgroup of the overall study"]
["2021/10/11 10.21","CRO2006O6","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","blood pressure","Systolic and diastolic pressure z score","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \rNo marked imbalance of baseline characteristics. \n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"PN","74% of those randomised had data for this outcome. ","N","No sensitivity analysis performed. ","PY","Similar proportions of missing data in both groups. ","PN",null,"Some concerns","Some concerns","74% of those randomised had data for this outcome. \r\nNo sensitivity analysis performed. \r\nSimilar proportions of missing data in both groups. \r\n",null,null,"N",null,"PN","Outcome measurement performed by a pediatrician unaware of allocation. ","N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"Y","Prospective statistical analysis plan included in protocol. ","N","Predefined outcome. ","N",null,"Low","Low","Prospective statistical analysis plan included in protocol. \r\n",null,null,"Some concerns","Some concerns","74% of those randomised had data for this outcome but there were similar proportions of missing data in both groups. "]
["2022/01/11 10.45","CRO2006O7","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","bone density","bone mineral content adjusted for height: Ratio of geometric means","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\nNo marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"PN","185/212 (87%) children living in centre with DEXA available were assessed.","PN",null,"PY","Levels of missing data were similar between groups. Most were missing because they were unable to be traced or declined follow up and because DEXA was only available in 2 centres for logistical reasons. 8 were excluded because of severe disability. ","PN",null,"Some concerns","Some concerns","185/212 (87%) children living in centre with DEXA available were assessed.\r\nLevels of missing data were similar between groups. Most were missing because they were unable to be traced or declined follow up and because DEXA was only available in 2 centres for logistical reasons. 8 were excluded because of severe disability. \r\n",null,null,"N","Measured using whole body dual energy x ray absorptiometry","PN",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Measured using whole body dual energy x ray absorptiometry\r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","Data analysis plan included in methods. Other follow up studies of the trial had prespecified statistical analysis plans.  ","N",null,"N",null,"Low","Low","Data analysis plan included in methods. Other follow up studies of the trial had prespecified statistical analysis plans.  ",null,null,"Some concerns","Some concerns","185/212 (87%) children living in centre with DEXA available were assessed but this was already a subgroup of the overall trial. "]
["2021/10/11 10.24","CRO2006O8","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Measures of lung function ","age 6-8 FVC, FEV1 and FEV1/FVC z scores","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \rNo marked imbalance of baseline characteristics. \n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"N","Less than 20% of those alive at follow up had available lung function data, primarily as a large number did not have lung function tests of adequate quality to be included. ","N",null,"PY","It is possible that those children with poorer lung function were less likely to complete a satisfactory test. Proportion of missing data were similar between groups. ","PY",null,"High","High","Less than 20% of those alive at follow up had available lung function data, primarily as a large number did not have lung function tests of adequate quality to be included. \r\n\r\nProportion of missing data were similar between groups. ",null,null,"N",null,"N","Outcome measurement performed by a pediatrician unaware of allocation. Spirogram was assessed for quality by independent examiners.  ","N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","\r\nOutcome measurement performed by a pediatrician unaware of allocation. Spirogram was assessed for quality by independent examiners.  ",null,null,"Y","Prospective statistical analysis plan included in protocol. ","N",null,"N",null,"Low","Low","Prospective statistical analysis plan included in protocol. \r\n\r\n",null,null,"High","High","High risk due to a large proportion of missing data. It is possible that those children with poorer lung function were less likely to complete a satisfactory test. "]
["2022/01/11 10.50","CRO2006O10I","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Measures of insulin and glucose homeostasis","fasting glucose and fasting insulin","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\nNo marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"N","71% of those recruited for this sub study completed this part of the assessment. ","N",null,"PY","Similar proportions of missing data in both groups. ","PN",null,"Some concerns","Some concerns","71% of those recruited for this sub study completed this part of the assessment. \r\n\r\nSimilar proportions of missing data in both groups. \r\n",null,null,"N","Measured on fasting blood tests. ","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","\r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"NI","Data analysis plan included in methods. Other follow up studies of the trial had prespecified statistical analysis plans.  ","PN",null,"PN",null,"Some concerns","Low","Data analysis plan included in methods. Other follow up studies of the trial had prespecified statistical analysis plans.  ",null,null,"Some concerns","Some concerns","71% of those recruited for this sub study completed this part of the assessment. \r\n\r\nSimilar proportions of missing data in both groups. "]
["2022/01/11 10.50","CRO2006O10II","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Measures of insulin and glucose homeostasis","Measures derived from minimal model including insulin sensitivity index, acute insulin release, glucose effectiveness, glucose disappearance constant","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\nNo marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"N","71% of those recruited for this sub study completed this part of the assessment. ","N",null,"PY","Similar proportions of missing data in both groups. ","PN",null,"Some concerns","Some concerns","71% of those recruited for this sub study completed this part of the assessment. \r\n\r\nSimilar proportions of missing data in both groups. \r\n",null,null,"N","Derived from measurements taken during an IV glucose tolerance test.","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","\r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"NI","Data analysis plan included in methods. Other follow up studies of the trial had prespecified statistical analysis plans.  ","PN",null,"PN",null,"Some concerns","Low","Data analysis plan included in methods. Other follow up studies of the trial had prespecified statistical analysis plans.  ",null,null,"Some concerns","Some concerns","71% of those recruited for this sub study completed this part of the assessment. \r\n\r\nSimilar proportions of missing data in both groups. "]
["2022/01/11 10.51","CRO2006O11","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Measures of HPA axis function","Ratio of geometric means for morning and evening salivary cortisol","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics.","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\nNo marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"PN","Approximately 66% of those presumed alive at 6-8 year follow up had salivary cortisol samples available. ","N",null,"PY","Similar proportion of missing data in both groups. ","PN",null,"Some concerns","Some concerns","Approximately 66% of those presumed alive at 6-8 year follow up had salivary cortisol samples available. ",null,null,"PN","Measured from salivary cortisol.","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","\r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"Y","Prospective statistical analysis plan included in protocol. ","N",null,"N",null,"Low","Low","Prospective data analysis plan included in ethics approval. \r\n\r\n",null,null,"Some concerns","Some concerns","Approximately 66% of those presumed alive at 6-8 year follow up had salivary cortisol samples available. Similar proportion of missing data in both groups. "]
["2022/01/14 16.50","MUR2008D1","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Death (after randomisation)","death","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"Y",">80% follow up at 5 years","NA",null,"NA",null,"NA",null,"Low","Low",">80% follow up at 5 years\r\n\r\n\r\n",null,null,"N","Objective outcome measure. ","N",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","\r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration document. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","N",null,"PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration document. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 16.50","MUR2008D4","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Survival free of major neurocognitive impairment at later childhood","total minus death or severe disability","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"PN","Data was available for 75% of those randomised. ","N","Sensitivity analysis was not performed. ","PY","Similar levels of missing data in both groups.  ","PN",null,"Some concerns","Some concerns","Data was available for 75% of those randomised. \r\nSensitivity analysis was not performed. \r\nSimilar levels of missing data in both groups.  ",null,null,"N","Assessment included a neurological examination for visual/hearing impairment and cerebral palsy along with 2 parental questionnaires. ","PN",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Assessment included a neurological examination for visual/hearing impairment and cerebral palsy along with 2 parental questionnaires. \r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration document. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","PN","Outcome defined prospectively in trial registration document. ","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration document. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\nOutcome defined prospectively in trial registration document. \r\n",null,null,"Some concerns","Some concerns","Some concerns due to missing data for 25% of those randomised. Similar proportion of missing data in both groups.  "]
["2022/01/14 16.50","MUR2008D6","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Cognitive impairment at later childhood","\"neurocognitive impairment","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"PN","Data was available for approximately 74% of those randomised. ","N","Sensitivity analysis was not performed. ","PY","Similar levels of missing data in both groups.  ","PN",null,"Some concerns","Some concerns","Data was available for 75% of those randomised. \r\nSensitivity analysis was not performed. \r\nSimilar levels of missing data in both groups.  ",null,null,"N",null,"PN",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","\r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration document. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","PN","Outcome clearly defined in methods but cut-off was not specified in trial registration. ","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration document. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\nOutcome clearly defined in methods but cut-off was not specified in trial registration. \r\n",null,null,"Some concerns","Some concerns","Some concerns due to missing data for 25% of those randomised. Similar proportion of missing data in both groups.  "]
["2022/01/14 16.53","MUR2008D8","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","cerebral palsy","non ambulatory CP","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"PN","Data was available for approximately 74% of those randomised. ","N","Sensitivity analysis was not performed. ","PY","Similar levels of missing data in both groups.  ","PN",null,"Some concerns","Some concerns","Data was available for 75% of those randomised. \r\nSensitivity analysis was not performed. \r\nSimilar levels of missing data in both groups.  ",null,null,"N","Outcome was assessed by a neurological examination. ","PN",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Outcome was assessed by a neurological examination. \r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration document. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","NI","Outcome clearly defined in methods but cut-off was not specified in trial registration. ","PN",null,"Some concerns","Low","SAP and protocol were not available for review. Outcome was specified in trial registration document. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\nOutcome clearly defined in methods but cut-off was not specified in trial registration. \r\n",null,null,"Some concerns","Some concerns","Some concerns due to missing data for 25% of those randomised. Similar proportion of missing data in both groups.  "]
["2022/01/14 16.53","MUR2008I2","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Deafness","Deafness","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"PN","Data was available for approximately 75% of those randomised. ","N","Sensitivity analysis was not performed. ","PY","Similar levels of missing data in both groups.  ","PN",null,"Some concerns","Some concerns","Data was available for 75% of those randomised. \r\nSensitivity analysis was not performed. \r\nSimilar levels of missing data in both groups.  ",null,null,"PN","Outcome assessed as part of a targeted neurological examination. ","PN",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Outcome assessed as part of a targeted neurological examination. \r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration document. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","PN","Outcomes defined in registration document.","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration document. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\nOutcomes defined in registration document.\r\n",null,null,"Some concerns","Some concerns","Some concerns due to missing data for 25% of those randomised. Similar proportion of missing data in both groups.  "]
["2022/01/14 16.54","MUR2008I3","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Blindness/visual impairment","Blindness/visual impairment","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"PN","Data was available for approximately 74% of those randomised. ","N","Sensitivity analysis was not performed. ","PY","Similar levels of missing data in both groups.  ","PN",null,"Some concerns","Some concerns","Data was available for 75% of those randomised. \r\nSensitivity analysis was not performed. \r\nSimilar levels of missing data in both groups.  ",null,null,"PN","Outcome assessed as part of a targeted neurological examination. ","PN",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Outcome assessed as part of a targeted neurological examination. \r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration document. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","PN","Outcomes specified in registration document. ","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration document. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\nOutcomes specified in registration document. \r\n",null,null,"Some concerns","Some concerns","Some concerns due to missing data for 25% of those randomised. Similar proportion of missing data in both groups.  "]
["2022/01/14 16.54","MUR2008I4","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Child behaviour","\"neurobehavioural impairment","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"PN","Data was available for approximately 74% of those randomised. ","N","Sensitivity analysis was not performed. ","PY","Similar levels of missing data in both groups.  ","PN",null,"Some concerns","Some concerns","Data was available for 75% of those randomised. \r\nSensitivity analysis was not performed. \r\nSimilar levels of missing data in both groups.  ",null,null,"N","Assessed by a parental questionnaire (Child behaviour checklist 1.5-5year)","PN",null,"N","Parents and researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Assessed by a parental questionnaire (Child behaviour checklist 1.5-5year). Parents and researchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration document. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","PN","Outcome clearly defined in methods but cut-off was not specified in trial registration. ","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration document. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\nOutcome clearly defined in methods but cut-off was not specified in trial registration. \r\n",null,null,"Some concerns","Some concerns","Some concerns due to missing data for 25% of those randomised. Similar proportion of missing data in both groups.  "]
["2022/01/14 16.56","MUR2008O1","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Growth assessments at later childhood","5year old weight, HC and height","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"PN","Data was available for approximately 74% of those randomised. ","N","Sensitivity analysis was not performed. ","PY","Similar levels of missing data in both groups.  ","PN",null,"Some concerns","Some concerns","Data was available for 74% of those randomised. \r\nSensitivity analysis was not performed. \r\nSimilar levels of missing data in both groups.  ",null,null,"N","Methods of measurement not stated but performed by trained staff unaware of allocation and likely used standard methods. ","N",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Methods of measurement not stated but performed by trained staff unaware of allocation and likely used standard methods. \r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration document. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.","N",null,"PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration document. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.\r\n\r\n",null,null,"Some concerns","Some concerns","Some concerns due to missing data for 26% of those randomised. Similar proportion of missing data in both groups.  "]
["2022/01/14 16.57","MUR2008O6","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Blood pressure","systolic and diastolic BP","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"PN","Data was available for approximately 74% of those randomised. ","N","Sensitivity analysis was not performed. ","PY","Similar levels of missing data in both groups.  ","PN",null,"Some concerns","Some concerns","Data was available for 74% of those randomised. \r\nSensitivity analysis was not performed. \r\nSimilar levels of missing data in both groups.  ",null,null,"N","Methods of measurement not stated but performed by trained staff unaware of allocation and likely used standard methods. ","N",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Methods of measurement not stated but performed by trained staff unaware of allocation and likely used standard methods. \r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration document. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.","N",null,"PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration document. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.\r\n\r\n",null,null,"Some concerns","Some concerns","Some concerns due to missing data for 26% of those randomised. Similar proportion of missing data in both groups."]

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["Unique ID","Reviewer","Study ID","Reference","Experimental","Comparator","Outcome","Result","Aim","Effect of adhering to intervention?","Weight","Randomization process","Deviations from intended interventions","Mising outcome data","Measurement of the outcome","Selection of the reported result","Overall Bias",null,null,null,null,"Randomization process","Deviations from intended interventions","Mising outcome data","Measurement of the outcome","Selection of the reported result","Overall Bias"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Assignment to intervention (the 'intention-to-treat' effect)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Total number of study = 0"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Low risk"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Some concerns"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"High risk"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adhering to intervention (the 'per-protocol' effect)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Total number of study = 0"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Low risk"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Some concerns"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"High risk"]

{"sheet":"Figure (ITT)","index":3,"n_rows":1,"n_cols":13,"rows_kept":1,"cut":false,"hidden":false,"merged":[]}
["Intention-to-treat","Unique ID","Study ID","Experimental","Comparator","Outcome","Weight","D1","D2","D3","D4","D5","Overall"]

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{"sheet":"Print (PP)","index":6,"n_rows":0,"n_cols":0,"rows_kept":0,"cut":false,"hidden":false,"merged":[]}

{"sheet":"Check","index":7,"n_rows":2,"n_cols":85,"rows_kept":2,"cut":false,"hidden":false,"merged":[[0,80,0,83],[0,0,0,12],[0,13,0,22],[0,23,0,40],[0,41,0,53],[0,54,0,68],[0,69,0,79]]}
["Basic information",null,null,null,null,null,null,null,null,null,null,null,null,"Domain 1. Randomization process",null,null,null,null,null,null,null,null,null,"Domain 2. Deviations from intended interventions",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Domain 3. Mising outcome data",null,null,null,null,null,null,null,null,null,null,null,null,"Domain 4. Measurement of the outcome",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Domain 5. Selection of the reported result",null,null,null,null,null,null,null,null,null,null,"Domain 6. Overall Bias"]
["Time","Unique ID","Assessor","Study ID","Reference","Experimental","Comparator","Outcome","Results","Aim","Effect of adhering to intervention?","Weight","Sources","1.1","1.2","Note for 1.1&1.2","1.3","Note for 1.3","1.0 Algorithm result","1.0 Assessor's Judgement","1.0 General note","1.0 Optional Question","1.0 Note for optional question","2.1","2.2","Note for 2.1&2.2","2.3","Note for 2.3","2.4","Note for 2.4","2.5","Note for 2.5","2.6","Note for 2.6","2.7","Note for 2.7","2.0 Algorithm result","2.0 Assessor's Judgement","2.0 General Notes","2.0 Optional Question","2.0 Note for optional question","3.1","Note for 3.1","3.2","Note for 3.2","3.3","Note for 3.3&3.4","3.4","Note for 3.4 (not use)","3.0 Algorithm result","3.0 Assessor's judgement","3.0 Gerenal notes","3.0 Optional Question","3.0 Note for optional question","4.1","Note for 4.1","4.2","Note for 4.2","4.3","Note for 4.3","4.4","Note for 4.4&4.5","4.5","Note for 4.5 (not use)","4.0 Algorithm result","4.0 Assessor's Judgement","4.0 General note","4.0 Optional Question","4.0 Note for optional question","5.1","Note for 5.1","5.2","Note for 5.2","5.3","Note for 5.3","5.0 Algorithm result","5.0 Assessor's Judgement","5.0 General note","5.0 Optional Question","5.0 Note for optional question","Algorithm's overall Judgement","Assessor's overall Judgement","6.0 General Note","6.0 Optional Question","6.0 Note for optional question"]

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["Unique ID",null,"Study ID",null,"Assessor"]
["Ref or Label",null,"Aim","adhering to intervention (the 'per-protocol' effect)","The effect of adhering to intervention…"]
["Experimental",null,"Comparator",null,"Source"]
["Outcome",null,"Results",null,"Weight"]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?"]
[null,"Risk of bias judgement"]
["Bias due to deviations from intended interventions","2.1 Were participants aware of their assigned intervention during the trial?"]
[null,"2.2 Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?"]
[null,"2.3. [If applicable:] If Y/PY/NI to 2.1 or 2.2: Were important non-protocol interventions balanced across intervention groups?"]
[null,"2.4. [If applicable:] Were there failures in implementing the intervention that could have affected the outcome?"]
[null,"2.5. [If applicable:] Was there non-adherence to the assigned intervention regimen that could have affected participants’ outcomes?"]
[null,"2.6. If N/PN/NI to 2.3, or Y/PY/NI to 2.4 or 2.5: Was an appropriate analysis used to estimate the effect of adhering to the intervention?"]
[null,"Risk of bias judgement"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?"]
[null,"Risk of bias judgement"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?"]
[null,"Risk of bias judgement"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?"]
[null,"5.3 ... multiple eligible analyses of the data?"]
[null,"Risk of bias judgement"]
["Overall bias","Risk of bias judgement"]

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["Unique ID",null,"Study ID",null,"Assessor"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental",null,"Comparator",null,"Source"]
["Outcome",null,"Results",null,"Weight"]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?"]
[null,"Risk of bias judgement"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?"]
[null,"Risk of bias judgement"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?"]
[null,"Risk of bias judgement"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?"]
[null,"Risk of bias judgement"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?"]
[null,"5.3 ... multiple eligible analyses of the data?"]
[null,"Risk of bias judgement"]
["Overall bias","Risk of bias judgement"]

{"sheet":"Function Tab","index":10,"n_rows":12,"n_cols":19,"rows_kept":12,"cut":false,"hidden":true,"merged":[]}
[null,"Journal article(s)","NA","Yes",null,"1.1 Was the allocation sequence random?",null,"2.1 Were participants aware of their assigned intervention during the trial?","2.1 Were participants aware of their assigned intervention during the trial?",null,"3.1 Were data for this outcome available for all, or nearly all, participants randomized?","Individually Randomized, Parallel Group Trials","4.1 Was the method of measuring the outcome inappropriate?","assignment to intervention (the 'intention-to-treat' effect)","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,null,"occurance of non-protocol interventions"]
["NA","Trial protocol","Favours experimental ","No (Please include reasons in the note)","Y","1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?","Low","2.2 Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?","2.2 Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,"3.2 If N/PN/NI to 3.1: Is there evidence that the result was not biased by missing outcome data?",null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?","adhering to intervention (the 'per-protocol' effect)","5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,null,"failures in implementing the intervention that could have affected the outcome"]
["Y","Statistical analysis plan (SAP)","Favours comparator ",null,"PY","1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?","High","2.3 [If applicable:] If Y/PY/NI to 2.1 or 2.2: Were important nonprotocol interventions balanced across intervention groups?","2.3 If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the trial context?",null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,"4.3 If N/PN/NI to 4.1 and 4.2: Were outcome assessors aware of the intervention received by study participants?",null,"5.3 ... multiple eligible analyses of the data?",null,null,null,"non-adherence to their assigned intervention by trial participants"]
["PY","Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Towards null ",null,"PN",null,"Some concerns","2.4 [If applicable:] Were there failures in implementing the intervention that could have affected the outcome?","2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?"]
["PN","Company-owned trial registry record (e.g. GSK Clinical Study Register record)","Away from null ",null,"N",null,null,"2.5 [If applicable:] Was there non-adherence to the assigned intervention regimen that could have affected participants’ outcomes?","2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?"]
["N","“Grey literature” (e.g. unpublished thesis)","Unpredictable",null,"NI",null,null,"2.6 If N/PN/NI to 2.3, or Y/PY/NI to 2.4 or 2.5: Was an appropriate analysis used to estimate the effect of adhering to the intervention?","2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?"]
["NI","Conference abstract(s) about the trial",null,null,null,null,null,null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?"]
[null,"Regulatory document (e.g. Clinical Study Report, Drug Approval Package)"]
[null,"Research ethics application"]
[null,"Grant database summary (e.g. NIH RePORTER, Research Councils UK Gateway to Research)"]
[null,"Personal communication with trialist"]
[null,"Personal communication with the sponsor"]