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{"sheet":"Results","index":1,"n_rows":61,"n_cols":85,"rows_kept":61,"cut":false,"hidden":false,"merged":[[0,0,0,12],[0,13,0,22],[0,80,0,83],[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. 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"]
["2022/01/14 11.55","CRO2006C1","AW&PM","Crowther 2006","CRO2006","Betamethasone ","Placebo","Death after randomisation","Death, RR 0.91","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","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","Data for this outcome were available for all participants. ","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome were available for all participants. \r\n\r\n\r\n",null,null,"N","Outcome assessment was objective. ","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Outcome assessment was objective. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.55","CRO2006C2","AW&PM","Crowther 2006","CRO2006","Betamethasone ","Placebo","Neurodevelopmental impairment at 2-6yo","\"Neurosensory disability\", RR 1","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","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","92% of those alive at follow up had an assessment of this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","92% of those alive at follow up had an assessment of this outcome. ",null,null,"N","Bayley Scales of infant development assessed by a psychologist and neurological examination performed by a developmental paediatrician. ","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Bayley Scales of infant development assessed by a psychologist and neurological examination performed by a developmental paediatrician. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.56","CRO2006C3","AW&PM","Crowther 2006","CRO2006","Betamethasone ","Placebo","Survival free of neurodevelopmental impairment 2-6yo","\"neurosensory disability: none\", RR 1","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","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","92% of those alive at follow up had an assessment of this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","92% of those alive at follow up had an assessment of this outcome. ",null,null,"N","Bayley Scales of infant development assessed by a psychologist and neurological examination performed by a developmental paediatrician. ","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Bayley Scales of infant development assessed by a psychologist and neurological examination performed by a developmental paediatrician. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.56","CRO2006C4","AW&PM","Crowther 2006","CRO2006","Betamethasone ","Placebo","Survival free of major neurodevelopmental impairment 2-6yo","\"Survival free of major neurosensory disability\", RR 1.04","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","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","92% of those alive at follow up had an assessment of this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","92% of those alive at follow up had an assessment of this outcome. ",null,null,"N","Bayley Scales of infant development assessed by a psychologist and neurological examination performed by a developmental paediatrician. ","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Bayley Scales of infant development assessed by a psychologist and neurological examination performed by a developmental paediatrician. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.56","CRO2006C5","AW&PM","Crowther 2006","CRO2006","Betamethasone ","Placebo","Cerebral palsy: Nil, mild, moderate, severe, any","Cerebral palsy: Nil, mild, moderate, severe","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","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","92% of those alive at follow up had an assessment of this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","92% of those alive at follow up had an assessment of this outcome. ",null,null,"N","Neurological examination was performed by a developmental paediatrician. ","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Neurological examination was performed by a developmental paediatrician. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.56","CRO2006C6","AW&PM","Crowther 2006","CRO2006","Betamethasone ","Placebo","Developmental delay or intellectual impairment: nil, mild, mod, severe, any","\"Delayed development\": none, mild, mod, severe, any","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","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","92% of those alive at follow up had an assessment of this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","92% of those alive at follow up had an assessment of this outcome. ",null,null,"N","Bayley Scales of infant development assessed by a psychologist. ","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Bayley Scales of infant development assessed by a psychologist. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.56","CRO2006C6I","AW&PM","Crowther 2006","CRO2006","Betamethasone ","Placebo","Developmental delay or intellectual impairment: nil, mild, mod, severe, any","\"Mental developmental index, mean and SD\"","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","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","89% of those alive at follow up had an assessment of this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","89% of those alive at follow up had an assessment of this outcome. ",null,null,"N","Bayley Scales of infant development assessed by a psychologist. ","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Bayley Scales of infant development assessed by a psychologist. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 12.05","CRO2006H1","AW&PM","Crowther 2006","CRO2006","Betamethasone ","Placebo","Child behaviour","\"total number within the clinical range\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); 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","92% of those alive at follow up had an assessment of this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","92% of those alive at follow up had an assessment of this outcome. \r\n\r\n\r\n",null,null,"N","Child behaviour checklist was completed by parent or caregiver. ","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Child behaviour checklist was completed by parent or caregiver. Caregivers, parents and research staff were all blinded to allocation. ",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","PN","The definition used for total number within the clinical range is a standard definition","N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.\r\nThe definition used for total number within the clinical range is a standard definition\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.56","CRO2006H2","AW&PM","Crowther 2006","CRO2006","Betamethasone ","Placebo","motor impairment ","\"psychomotor developmental index, mean and SD\"","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","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","88% of those alive at follow up had an assessment of this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","88% of those alive at follow up had an assessment of this outcome. ",null,null,"N","Bayley Scales of infant development assessed by a psychologist. ","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Bayley Scales of infant development assessed by a psychologist. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 12.09","CRO2006H3","AW&PM","Crowther 2006","CRO2006","Betamethasone ","Placebo","Deafness","Deafness, RR 0.77","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","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","96% of those alive at follow up had an assessment of this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","96% of those alive at follow up had an assessment of this outcome. ",null,null,"N","Hearing was assessed by a developmental paediatrician. ","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Hearing was assessed by a developmental paediatrician. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 12.08","CRO2006H4","AW&PM","Crowther 2006","CRO2006","Betamethasone ","Placebo","Blindness/visual impairment","Blindness, RR 2.94","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","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","96% of those alive at follow up had an assessment of this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","96% of those alive at follow up had an assessment of this outcome. ",null,null,"N","Vision was assessed by a developmental paediatrician. ","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Vision was assessed by a developmental paediatrician. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N","Definition of blindness was standard. ","N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.\r\nDefinition of blindness was standard. \r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.56","CRO2006H5","AW&PM","Crowther 2006","CRO2006","Betamethasone ","Placebo","Hypertension","Hypertension, rr 0.98","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","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","58% of those alive at follow up had assessments for this outcome. ","N",null,"PY","Each group had similar proportions of missing data. ","PN",null,"Some concerns","Some concerns","Approximately 58% of participants alive at follow up had assessments data for this outcome. \r\n\r\nEach group had similar proportions of missing data. \r\n",null,null,"N","Blood pressure measured by a paediatrician according to local practice and hypertension defined as systolic or diastolic pressure above the 95th centile.","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Blood pressure measured by a paediatrician according to local practice and hypertension defined as systolic or diastolic pressure above the 95th centile.\r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","PN","The definition used is a standard definition for childhood hypertension. ","N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.\r\nThe definition used is a standard definition for childhood hypertension. \r\n",null,null,"Some concerns","Some concerns","Some concerns of bias due to missing data as only 58% of participants alive at follow up had assessments data for this outcome but treatment groups had similar proportions of missing data. "]
["2022/01/14 12.10","CRO2006H8","AW&PM","Crowther 2006","CRO2006","Betamethasone ","Placebo","Asthma or recurrent wheeze","Asthma","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","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","98% of those alive at follow up had an assessment of this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","98% of those alive at follow up had an assessment of this outcome. ",null,null,"N","Outcome was assessed via a parental questionnaire. ","PN",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Outcome was assessed via a parental questionnaire. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.\r\nPrespecified definition described in methods.\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.57","CRO2006H9","AW&PM","Crowther 2006","CRO2006","Betamethasone ","Placebo","Any respiratory disease ","“admission for respiratory illness”","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","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","98% of those alive at follow up had an assessment of this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","98% of those alive at follow up had an assessment of this outcome. ",null,null,"PN","Although outcome assessors were blinded to allocation,  parental recall of reasons for hospital admissions may be unreliable. ","N",null,"N",null,"NA",null,"NA",null,"Low","Some concerns","Although outcome assessors were blinded to allocation, parental recall of reasons for hospital admissions may be unreliable. \r\n\r\n\r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","PN",null,"PN",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.\r\nPrespecified definition described in methods.\r\n",null,null,"Some concerns","Some concerns","Some concerns in the measurement of the outcome because, despite parents being blinded to allocation, parental recall of reasons for hospital admissions may be unreliable.  "]
["2022/01/14 12.46","CRO2006K1I","AW&PM","Crowther 2006","CRO2006","Betamethasone ","Placebo","Hospital readmission at childhood follow up","\"Hospital readmission\" in 2 year follow up publication, RR 1.04","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","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","98% of those alive at follow up had an assessment of this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","98% of those alive at follow up had an assessment of this outcome. ",null,null,"N","Outcome assessed by a parental questionnaire. ","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Outcome assessed by a parental questionnaire. Parents/caregivers were blinded to allocation. ",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.57","CRO2006N1I","AW&PM","Crowther 2006","CRO2006","Betamethasone ","Placebo","Growth assessments at 2-6yo, weight","Weight in 2 year follow up publication, including z scores","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","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","96% of those alive at follow up had an assessment of this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","96% of those alive at follow up had an assessment of this outcome. ",null,null,"N","Measurements performed by a developmental paediatrician. ","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Measurements performed by a developmental paediatrician. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.57","CRO2006N1II","AW&PM","Crowther 2006","CRO2006","Betamethasone ","Placebo","head circumference at 2-6yo","HC in 2 year follow up publication, including z scores","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","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","96% of those alive at follow up had an assessment of this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","96% of those alive at follow up had an assessment of this outcome. ",null,null,"N","Measurements performed by a developmental paediatrician. ","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Measurements performed by a developmental paediatrician. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.57","CRO2006N1III","AW&PM","Crowther 2006","CRO2006","Betamethasone ","Placebo","Growth assessment at 2-6yo, height","Height in 2 year follow up publication, including z scores","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","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","96% of those alive at follow up had an assessment of this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","96% of those alive at follow up had an assessment of this outcome. ",null,null,"N","Measurements performed by a developmental paediatrician. ","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Measurements performed by a developmental paediatrician. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.57","CRO2006N3I","AW&PM","Crowther 2006","CRO2006","Betamethasone ","Placebo","Blood pressure, systolic","systolic blood pressure z scores","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","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","62% of those alive at follow up had an assessment of this outcome. ","N",null,"PY","Each group had similar proportions of missing data. ","PN",null,"Some concerns","Some concerns","62% of those alive at follow up had an assessment of this outcome. ",null,null,"N","Measurements performed by a developmental paediatrician. ","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Measurements performed by a developmental paediatrician. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Some concerns","Some concerns","Some concerns of risk or bias due to missing outcome data as only 62% of those alive at follow up had an assessment of this outcome. Intervention and placebo groups had similar proportions of missing data. "]
["2022/01/14 11.57","CRO2006N3II","AW&PM","Crowther 2006","CRO2006","Betamethasone ","Placebo","Blood pressure, diastolic","diastolic blood pressure z scores","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","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","58% of those alive at follow up had an assessment of this outcome. ","N",null,"PY","Each group had similar proportions of missing data. ","PN",null,"Some concerns","Some concerns","58% of those alive at follow up had an assessment of this outcome. ",null,null,"N","Measurements performed by a developmental paediatrician. ","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Measurements performed by a developmental paediatrician. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Some concerns","Some concerns","Some concerns of risk or bias due to missing outcome data as only 58% of those alive at follow up had an assessment of this outcome. Treatment groups had similar proportions of missing data. "]
["2022/01/15 13.26","PEL2007C1","AW&JH","Peltoniemi2007",2675274,"Betamethasone ","Placebo","Death (after randomisation)","Death after discharge plus death before discharge plus feta 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","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. Examiners and families were unaware of allocation at childhood follow up.","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. Examiners and families were unaware of allocation at childhood follow up.\r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"PY","16% loss to follow up from those initially randomised but it appears that mortality status was known for them even if a full assessment was not completed. ","NA",null,"NA",null,"NA",null,"Low","Low","Loss to follow up of 16% but mortality outcome appeared to be known for almost all randomised. \r\n\r\n",null,null,"N","Objective outcome. ","PN",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Objective outcome. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","N",null,"N","Absolute numbers of events were reported. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/26 19.05","PEL2007C4","AW&JH","Peltoniemi2007",2675274,"Betamethasone ","Placebo","Survival free of major neurodevelopmental impairment at age 2 to <6 years ","Survival free of major neurodevelopmental impairment at age 2 ","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","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. Examiners and families were unaware of allocation at childhood follow up.","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. Examiners and families were unaware of allocation at childhood follow up.\r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"PN","Loss to follow up was 19%in the intervention group and 14% in the placebo group but the proportion with death or severe NDI was lower than this (9% and 4%)","N","No sensitivity analysis performed.","PY","The proportion of missing data was different between the groups. ","PY",null,"High","High","Loss to follow up was 19%in the intervention group and 14% in the placebo group but the proportion with death or severe NDI was lower than this (9% and 4%)\r\nNo sensitivity analysis performed.\r\n",null,null,"N","Developmental assessments were performed by a neuropsychologist and either a paediatrician or paediatric neurologist. ","PN",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Developmental assessments were performed by a neuropsychologist and either a paediatrician or paediatric neurologist. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","PN","Outcome clearly defined in trial registration prior to follow up study. ","N","Absolute numbers of events were reported. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"High","High","High risk overall due to high risk of bias due to missing outcome data because of differential loss to follow up in the treatment groups and losses exceeded the number with the outcome.  "]
["2022/01/15 13.30","PEL2007C5","AW&JH","Peltoniemi2007",2675274,"Betamethasone ","Placebo","Cerebral palsy ","Cerebral palsy ","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","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. Examiners and families were unaware of allocation at childhood follow up.","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. Examiners and families were unaware of allocation at childhood follow up.\r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"N","Loss to follow up was 19%in the intervention group and 14% in the placebo group, much higher than the proportion with the outcome of CP. ","N","No sensitivity analysis performed.","PY","The proportion of missing data was different between the groups but documented reasons for loss to follow up were parental refusal or moving to an unknown address. ","PY",null,"High","High","Loss to follow up was 19% in the intervention group and 14% in the placebo group, much higher than the proportion with the outcome of CP. \r\nNo sensitivity analysis performed.",null,null,"N","Neurological examination was performed by a paediatrician or a paediatric neurologist. ","PN",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Neurological examination was performed by a paediatrician or a paediatric neurologist. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was not specified in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","PN","Outcome timing clear and assessment was using a clearly defined method. ","N","Absolute numbers of events were reported. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was not specified in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"High","High","High risk overall due to high risk of bias due to missing outcome data because there was differential loss to follow up and losses exceeded the number with cerebral palsy. "]
["2022/01/15 13.30","PEL2007C6","AW&JH","Peltoniemi2007",2675274,"Betamethasone ","Placebo","Developmental delay or intellectual impairment at age 2 to <6 years ","Developmental delay or intellectual impairment at age 2 mild, mod to severe based on MDI score 70-84  and <70","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","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. Examiners and families were unaware of allocation at childhood follow up.","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. Examiners and families were unaware of allocation at childhood follow up.\r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"N","Of those that completed follow up, only 73% of the intervention and 77% of the placebo group had data for this outcome. ","N","No sensitivity analysis performed. ","PY","The proportion of missing data was different between the groups but documented reasons for loss to follow up were parental refusal or moving to an unknown address. No reasons were documented for the discrepancy in proportion with psychological testing performed. ","PY",null,"High","High","Of those that completed follow up, only 73% of the intervention and 77% (Overall 59% of those randomised) of the placebo group had data for this outcome. \r\nNo sensitivity analysis performed.  No explanation provided for the difference in proportion with full psychological testing. ",null,null,"N","The Bayley scales of infant development were assessed by a neuropsychologist.","PN",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","The Bayley scales of infant development were assessed by a neuropsychologist.\r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","PN","Outcome scale defined in trial registration prior to follow up study. ","N","Absolute numbers of events were reported. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"High","High","High risk overall due to high risk of bias due to missing outcome data as there was differential loss to follow up in the treatment groups and only 59% had data for this outcome."]
["2022/01/15 13.31","PEL2007H1","AW&JH","Peltoniemi2007",2675274,"Betamethasone ","Placebo","Childhood behaviour","Reported as temperament using “Early Child Behaviour questionnaire” summary scales","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","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. Examiners and families were unaware of allocation at childhood follow up.","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. Examiners and families were unaware of allocation at childhood follow up.\r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"PY","Although this group was a subset of the original study from one centre (71% of the total randomised) most of the group were followed up for this outcome (85% of those alive).","NA",null,"NA",null,"NA",null,"Low","Low","Although this group was a subset of the original study from one centre (71% of the total randomised) most of the group were followed up for this outcome (85% of those alive).\r\n\r\n",null,null,"PN","Assessed by parental completion of the Early Child Behaviour questionnaire","PN",null,"N","Outcome assessors (study investigators and parents) were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Assessed by parental completion of the Early Child Behaviour questionnaire. Parents and study investigators were blinded to allocation. \r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration but not the scale used. Outcome definition and analysis unlikely to have been selected based on results. ","PN","All of the expected outcomes from the measurement tool have been recorded. ","N",null,"Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration but not the scale used. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 13.33","PEL2007H3","AW&JH","Peltoniemi2007",2675274,"Betamethasone ","Placebo","Deafness","Need for use of a hearing aid","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","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. Examiners and families were unaware of allocation at childhood follow up.","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. Examiners and families were unaware of allocation at childhood follow up.\r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"PN","Loss to follow up was 19%in the intervention group and 14% in the placebo group.","N","No sensitivity analysis performed. ","PY","The proportion of missing data was different between the groups but documented reasons for loss to follow up were parental refusal or moving to an unknown address. ","PN",null,"Some concerns","Some concerns","Loss to follow up was 19%in the intervention group and 14% in the placebo group.\r\nNo sensitivity analysis performed. \r\nThe proportion of missing data was different between the groups but documented reasons for loss to follow up were parental refusal or moving to an unknown address. \r\n",null,null,"PN","Medical history was obtained by a questionnaire. Parents/caregivers were blinded to allocation. ","PN",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Medical history was obtained by a questionnaire. Parents/caregivers were blinded to allocation. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","PN",null,"N","Absolute numbers of events were reported. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Some concerns","Some concerns","Some concerns as no events were seen for this outcome but the proportion of missing data was different between treatment groups. "]
["2022/01/15 13.34","PEL2007H8","AW&JH","Peltoniemi2007",2675274,"Betamethasone ","Placebo","Asthma or recurrent wheeze ","respiratory admissions description minus pneumonia","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","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. Examiners and families were unaware of allocation at childhood follow up.","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. Examiners and families were unaware of allocation at childhood follow up.\r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"PN","Loss to follow up was 19%in the intervention group and 14% in the placebo group.","N","No sensitivity analysis performed. ","PY","The proportion of missing data was different between the groups but documented reasons for loss to follow up were parental refusal or moving to an unknown address. ","PN",null,"Some concerns","Some concerns","Loss to follow up was 19%in the intervention group and 14% in the placebo group.\r\nNo sensitivity analysis performed. \r\nThe proportion of missing data was different between the groups but documented reasons for loss to follow up were parental refusal or moving to an unknown address. \r\n",null,null,"PY","Although outcome assessors were blinded to allocation,  parental recall of reasons for hospital admissions may be unreliable. ","PN",null,"NA",null,"NA",null,"NA",null,"High","Some concerns","Although outcome assessors were blinded to allocation,  parental recall of reasons for hospital admissions may be unreliable. ",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","PN"," ","N","Absolute numbers of events were reported. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Some concerns","Some concerns","Overall some concerns due to some concerns of risk of bias due to missing outcome data because loss to follow up differed between groups and some concerns of risk of bias in the measurement of the outcome. "]
["2022/01/15 13.34","PEL2007H9","AW&JH","Peltoniemi2007",2675274,"Betamethasone ","Placebo","Any respiratory disease ","respiratory admissions","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","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. Examiners and families were unaware of allocation at childhood follow up.","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. Examiners and families were unaware of allocation at childhood follow up.\r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"PN","Loss to follow up was 19%in the intervention group and 14% in the placebo group.","N","No sensitivity analysis performed. ","PY","The proportion of missing data was different between the groups but documented reasons for loss to follow up were parental refusal or moving to an unknown address. ","PN",null,"Some concerns","Some concerns","Loss to follow up was 19%in the intervention group and 14% in the placebo group.\r\nNo sensitivity analysis performed. \r\nThe proportion of missing data was different between the groups but documented reasons for loss to follow up were parental refusal or moving to an unknown address. ",null,null,"PY","Although outcome assessors were blinded to allocation,  parental recall of reasons for hospital admissions may be unreliable. ","PN",null,"NA",null,"NA",null,"NA",null,"High","Some concerns","Although outcome assessors were blinded to allocation,  parental recall of reasons for hospital admissions may be unreliable. ",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","PN",null,"N","Absolute numbers of events were reported. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Some concerns","Some concerns","Overall some concerns due to some concerns of risk of bias due to missing outcome data because loss to follow up differed between groups and some concerns of risk of bias in the measurement of the outcome. "]
["2022/01/11 20.09","PEL2007K1","AW&JH","Peltoniemi2007",2675274,"Betamethasone ","Placebo","Hospital re-admission at childhood follow-up","Hospital re-admission status by age 2","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","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. Examiners and families were unaware of allocation at childhood follow up.","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. Examiners and families were unaware of allocation at childhood follow up.\r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"PN","Missing data for this outcome for this outcome was similar between the two groups (24% and 22% of those alive in the intervention and placebo groups respectively). No sensitivity analysis performed. ","N","No sensitivity analysis performed. ","PY",null,"PN",null,"Some concerns","Some concerns","Missing data for this outcome for this outcome was similar between the two groups (24% and 22% of those alive in the intervention and placebo groups respectively). No sensitivity analysis performed. ",null,null,"N","The outcome of any hospital readmission within 2 years is likely reliable. Outcome assessed by parental questionnaire. ","PN",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","The outcome of any hospital readmission within 2 years is likely reliable. \r\n\r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP not available for review but detailed analysis plans were included on the registered trial protocol and were overseen by a data safety monitoring committee. An interim analysis was also performed. ","PN","Outcome clearly defined in trial registration prior to follow up study. ","N","Absolute numbers of events were reported. ","Low","Low","SAP not available for review but detailed analysis plans were included on the registered trial protocol and were overseen by a data safety monitoring committee. ",null,null,"Some concerns","Some concerns","Overall some concerns due to some concerns of risk of bias due to missing outcome data for 23% of those alive for follow up, but similar levels of missing data between groups. "]
["2022/01/15 13.37","PEL2007N1","AW&JH","Peltoniemi2007",2675274,"Betamethasone ","Placebo","Growth assessments at age 2-6years, height, weight, HC","Growth assessments at age 2, height, weight, HC and SD from reference for age","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","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. Examiners and families were unaware of allocation at childhood follow up.","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. Examiners and families were unaware of allocation at childhood follow up.\r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"PN","Loss to follow up for this outcome was similar between the two groups (76% and 78% of those alive in the intervention and placebo groups respectively).","N","No sensitivity analysis performed. ","PY","This outcome was unlikely to be markedly impacted by the similar loss in each group. ","PN",null,"Some concerns","Some concerns","Missing data for this outcome for this outcome was similar between the two groups (24% and 22% of those alive in the intervention and placebo groups respectively). No sensitivity analysis performed. \r\n",null,null,"PN","Method of measurement not stated but unlikely to differ between treatment groups. ","N",null,"N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Method of measurement not stated but unlikely to differ between treatment groups. \r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","PN","Outcome clearly defined in trial registration prior to follow up study. ","N",null,"Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Some concerns","Some concerns","Overall some concerns due to some concerns of risk of bias due to missing outcome data because data was missing for 23% of those alive for follow up but with similar levels of missing data between groups. "]
["2022/01/15 09.52","WAP2006C1","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","Death after randomisation","death before discharge plus death between discharge and childhood follow up","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","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"PY","84% of those randomised had data available.  ","NA",null,"NA",null,"NA",null,"Low","Low","84% of those randomised had data available.  \r\n\r\n\r\n",null,null,"N",null,"N",null,"N","Assessments were performed by centrally trained and certified study personnel who were unaware of the treatment assignment.","NA",null,"NA",null,"Low","Low","\r\n\r\nAssessments were performed by centrally trained and certified study personnel who were unaware of the treatment assignment.\r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was in protocol documentation and is unlikely to have been selected on the basis of results. ","N",null,"N","Absolute number of events was reported. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was in protocol documentation and is unlikely to have been selected on the basis of results. \r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 09.56","WAP2006C2","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","Neurodevelopmental impairment at early childhood","PDI <85","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","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"PN","80% of those alive at 2 year follow up had Bayley scales assessed. 235 /291 in intervention group and 230/288 in placebo. ","PN","No sensitivity analysis performed. ","PY","The amount of missing data was similar between groups. Missing participants differed slightly in proportions of different ethnic groups. ","PN",null,"Some concerns","Some concerns","80% of those alive at 2 year follow up had Bayley scales assessed (78% of those randomised). No sensitivity analysis performed. \r\nThe amount of missing data was similar between groups. Missing participants differed slightly in proportions of different ethnic groups. ",null,null,"N","Assessment included physical and neurological examination and Bayley scales of infant development. ","PN",null,"N","Assessments were performed by centrally trained and certified study personnel who were unaware of the treatment assignment.","NA",null,"NA",null,"Low","Low","Assessment included physical and neurological examination and Bayley scales of infant development. \r\n\r\nAssessments were performed by centrally trained and certified study personnel who were unaware of the treatment assignment.\r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was in protocol documentation and is unlikely to have been selected on the basis of results. ","PN",null,"N","Absolute number of events was reported. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was in protocol documentation and is unlikely to have been selected on the basis of results. \r\n\r\n",null,null,"Some concerns","Some concerns","Some concerns due to missing data (20% missing data). Despite lack of SAP to review, outcome was well defined in the methods section and noted to be prespecified.  "]
["2022/01/15 09.56","WAP2006C3","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","Survival free of neurodevelopmental impairment at age 2 to <6 years (none of: visual impairment, hearing impairment, intellectual impairment [developmental quotient or intelligence quotient more than one standard deviation below the mean], motor impairment [mild or major impairment by appropriate mode of assessment], cerebral palsy or as defined by authors)","Total - PDI<85 and 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","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"PN","80% of those alive at 2 year follow up had Bayley scales assessed. 235 /291 in intervention group and 230/288 in placebo. ","PN","No sensitivity analysis performed. ","PY","The amount of missing data was similar between groups. Missing participants differed slightly in proportions of different ethnic groups. ","PN",null,"Some concerns","Some concerns","80% of those alive at 2 year follow up had Bayley scales assessed (78% of those randomised). No sensitivity analysis performed. \r\nThe amount of missing data was similar between groups. Missing participants differed slightly in proportions of different ethnic groups. ",null,null,"N","Assessment included physical and neurological examination and Bayley scales of infant development. ","PN",null,"N","Assessments were performed by centrally trained and certified study personnel who were unaware of the treatment assignment.","NA",null,"NA",null,"Low","Low","Assessment included physical and neurological examination and Bayley scales of infant development. \r\n\r\nAssessments were performed by centrally trained and certified study personnel who were unaware of the treatment assignment.\r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was in protocol documentation and is unlikely to have been selected on the basis of results. ","PN","Methods stated that this was a prespecified outcome. ","N","Absolute number of events was reported. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was in protocol documentation and is unlikely to have been selected on the basis of results. \r\n",null,null,"Some concerns","Some concerns","Some concerns due to missing data for 20%. Despite lack of SAP to review, outcome was well defined in the methods section and noted to be prespecified.  "]
["2022/01/15 09.57","WAP2006C4","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","Survival free of major neurodevelopmental impairment at early childhood","cerebral palsy","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","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"PN","80% of those alive at 2 year follow up had Bayley scales assessed. 235 /291 in intervention group and 230/288 in placebo. ","PN","No sensitivity analysis performed. ","PY","The amount of missing data was similar between groups. Missing participants differed slightly in proportions of different ethnic groups. \r\n","PN",null,"Some concerns","Some concerns","80% of those alive at 2 year follow up had Bayley scales assessed (78% of those randomised). No sensitivity analysis performed. \r\nThe amount of missing data was similar between groups. Missing participants differed slightly in proportions of different ethnic groups. ",null,null,"N","Assessment included physical and neurological examination and Bayley scales of infant development. ","PN",null,"N","Assessments were performed by centrally trained and certified study personnel who were unaware of the treatment assignment.","NA",null,"NA",null,"Low","Low","Assessment included physical and neurological examination and Bayley scales of infant development. \r\n\r\nAssessments were performed by centrally trained and certified study personnel who were unaware of the treatment assignment.\r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was in protocol documentation and is unlikely to have been selected on the basis of results. ","PN","Methods stated the outcomes were prespecified. ","N","Absolute number of events was reported. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was in protocol documentation and is unlikely to have been selected on the basis of results. \r\n\r\n",null,null,"Some concerns","Some concerns","Some concerns due to missing data. \r\nDespite lack of SAP to review, outcome was well defined in the methods section and noted to be prespecified.  "]
["2022/01/15 09.55","WAP2006C5","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","Cerebral palsy","cerebral palsy","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","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"PY","84% of those alive at 2 year follow up had follow up assessments. 248 /291 in intervention group and 238/288 in placebo. ","NA",null,"NA",null,"NA",null,"Low","Low","84% of those alive at 2 year follow up had follow up assessments (82% of those randomised). Similar proportion of missing data in each group. \r\n\r\n\r\n",null,null,"N","Assessment included physical and neurological examination.","PN",null,"N","Assessments were performed by centrally trained and certified study personnel who were unaware of the treatment assignment.","NA",null,"NA",null,"Low","Low","Assessment included physical and neurological examination.\r\n\r\nAssessments were performed by centrally trained and certified study personnel who were unaware of the treatment assignment.\r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was in protocol documentation. Analysis plans were included in the methods but not in sufficient detail to explain the rationale behind multiple subgroup analyses being reported involving cerebral palsy that may not have been prespecified. ","PN",null,"NI","Absolute number of events was reported. ","Some concerns","Some concerns","Protocol with planned statistical analysis was available for review. Outcome was in protocol documentation. Analysis plans were included in the methods but not in sufficient detail to explain the rationale behind multiple subgroup analyses being reported involving cerebral palsy that may not have been prespecified. ",null,null,"Some concerns","Some concerns","SAP not available for review. Analysis plans were included in the methods but not in sufficient detail to explain the rationale behind multiple subgroup analyses involving cerebral palsy that may not have been prespecified. "]
["2022/01/15 10.03","WAP2006C6","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","Developmental delay or intellectual impairment at age 2 to <6 years ","Bayley scales MDI score mean and number in categories of moderate and severe","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","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"N","80% of those alive at 2 year follow up had Bayley scales assessed. 235 /291 in intervention group and 230/288 in placebo. ","N","No sensitivity analysis performed. ","PY","The amount of missing data was similar between groups. Missing participants differed slightly in proportions of different ethnic groups. \r\n","PN",null,"Some concerns","Some concerns","80% of those alive at 2 year follow up had Bayley scales assessed (78% of those randomised). No sensitivity analysis performed. \r\nThe amount of missing data was similar between groups. Missing participants differed slightly in proportions of different ethnic groups. ",null,null,"N","Assessment used Bayley scales of infant development. ","PN",null,"N","Assessments were performed by centrally trained and certified study personnel who were unaware of the treatment assignment.","NA",null,"NA",null,"Low","Low","Assessment used Bayley scales of infant development. \r\n\r\nAssessments were performed by centrally trained and certified study personnel who were unaware of the treatment assignment.\r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was in protocol documentation and is unlikely to have been selected on the basis of results. ","PN","All expected scales were reported (PDI and MDI)","PN",null,"Low","Low","Protocol with planned statistical analysis was available for review. Outcome was in protocol documentation and is unlikely to have been selected on the basis of results. \r\nAll expected scales were reported (PDI and MDI)\r\n",null,null,"Some concerns","Some concerns","Some concerns due to missing data. \r\nDespite lack of SAP to review, outcome was well defined in the methods section and noted to be prespecified.  "]
["2022/01/15 10.00","WAP2006H8","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","Asthma or recurrent wheeze","Asthma","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","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"PY","84% of those alive at 2 year follow up had follow up assessments. 248 /291 in intervention group and 238/288 in placebo. \r\nNo sensitivity analysis performed. \r\n","NA",null,"NA",null,"NA",null,"Low","Low","84% of those alive at 2 year follow up had follow up assessments(82% of those randomised). 248 /291 in intervention group and 238/288 in placebo. \r\nNo sensitivity analysis performed. \r\n\r\n\r\n\r\n",null,null,"N",null,"PN",null,"N","Assessments were performed by centrally trained and certified study personnel who were unaware of the treatment assignment.","NA",null,"NA",null,"Low","Low","\r\n\r\nAssessments were performed by centrally trained and certified study personnel who were unaware of the treatment assignment.\r\n\r\n",null,null,"PY","Protocol available and did not include this outcome. Outcome in methods but appears to have been selected from a section on \"chronic conditions\" from an interview . It is unclear if the outcome or method of defining asthma was prespecified.","NI",null,"N","Absolute number of events was reported. ","Some concerns","Some concerns","Protocol available and did not include this outcome. Outcome in methods but appears to have been selected from a section on \"chronic conditions\" from an interview . It is unclear if the outcome or method of defining asthma was prespecified.",null,null,"Some concerns","Some concerns","\r\n\r\n\r\nSome concerns for selection of the reported result. Protocol available and did not include this outcome. Outcome in methods but appears to have been selected from a section on \"chronic conditions\" from an interview . It is unclear if the outcome or method of defining asthma was prespecified. Other domains low risk. "]
["2022/01/12 11.20","WAP2006K1","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","Hospital re-admission at childhood follow-up","hospital readmission after discharge","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","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"PY","16.1% of those alive were not able to be followed up at 2 year follow up, 43 infants in the intervention group and 50 in the placebo group. ","NA",null,"NA",null,"NA",null,"Low","Low","84% of those alive at 2 year follow up had follow up assessments(82% of those randomised). 248 /291 in intervention group and 238/288 in placebo. \r\nNo sensitivity analysis performed. ",null,null,"N",null,"PN",null,"N","The mother or healthcare provider was the assessor for this outcome but both were blinded to allocation. ","NA",null,"NA",null,"Low","Low","The mother or healthcare provider was the assessor for this outcome but both were blinded to allocation. Although parental memory of healthcare events is unreliable, this only required memory of readmission or not. \r\n\r\n",null,null,"PY","SAP not available for review. Analysis plans were included in the methods. ","PN","Outcome was prespecified in protocol document. ","N","Absolute number of events was reported. ","Low","Low","SAP not available for review. Analysis plans were included in the methods. \r\nOutcome was prespecified in protocol document. \r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 10.08","WAP2006N1I","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","weight at childhood follow up","weight at 2years and mean weight percentile","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","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"PY","84% of those alive at 2 year follow up had follow up assessments. 248 /291 in intervention group and 238/288 in placebo. 248 /291 in intervention group and 238/288 in placebo. ","NA",null,"NA",null,"NA",null,"Low","Low","84% of those alive at 2 year follow up had follow up assessments(82% of those randomised). 248 /291 in intervention group and 238/288 in placebo. No sensitivity analysis performed. ",null,null,"N",null,"PN",null,"N","Assessments were performed by centrally trained and certified study personnel who were unaware of the treatment assignment.","NA",null,"NA",null,"Low","Low","\r\n\r\nAssessments were performed by centrally trained and certified study personnel who were unaware of the treatment assignment.\r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was in protocol documentation and is unlikely to have been selected on the basis of results. ","PN","This outcome was prespecified. ","PN","Mean weight and weight percentile was reported but it is unclear if this was the original intended analysis. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was in protocol documentation and is unlikely to have been selected on the basis of results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 10.09","WAP2006N1II","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","Head circumference at childhood follow up","HC at 2 years and mean HC percentile","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","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"PY","84% of those alive at 2 year follow up had follow up assessments. 248/291 in intervention group and 238/288 in placebo. ","NA",null,"NA",null,"NA",null,"Low","Low","84% of those alive at 2 year follow up had follow up assessments(82% of those randomised). 248 /291 in intervention group and 238/288 in placebo. \r\nNo sensitivity analysis performed. ",null,null,"N",null,"PN",null,"N","Assessments were performed by centrally trained and certified study personnel who were unaware of the treatment assignment.","NA",null,"NA",null,"Low","Low","\r\n\r\nAssessments were performed by centrally trained and certified study personnel who were unaware of the treatment assignment.\r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was in protocol documentation and is unlikely to have been selected on the basis of results. ","PN","This outcome was prespecified. ","PN","Mean HC and HC percentile were reported","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was in protocol documentation and is unlikely to have been selected on the basis of results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 10.08","WAP2006N1III","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","height at childhood follow up","height at 2 years and mean height percentile","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","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"PY","84% of those alive at 2 year follow up had follow up assessments. 248 /291 in intervention group and 238/288 in placebo. 248 /291 in intervention group and 238/288 in placebo. ","NA",null,"NA",null,"NA",null,"Low","Low","84% of those alive at 2 year follow up had follow up assessments(82% of those randomised). 248 /291 in intervention group and 238/288 in placebo. \r\nNo sensitivity analysis performed. ",null,null,"N",null,"PN",null,"N","Assessments were performed by centrally trained and certified study personnel who were unaware of the treatment assignment.","NA",null,"NA",null,"Low","Low","\r\n\r\nAssessments were performed by centrally trained and certified study personnel who were unaware of the treatment assignment.\r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was not in protocol documentation but is unlikely to have been selected on the basis of results. ","PN",null,"PN","Mean height and height percentile were reported ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was not in protocol documentation but is unlikely to have been selected on the basis of results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 10.10","WAP2006N3","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","blood pressure","SBP and DBP","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","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"PY","84% of those alive at 2 year follow up had follow up assessments. 248 /291 in intervention group and 238/288 in placebo. 248 /291 in intervention group and 238/288 in placebo. ","NA",null,"NA",null,"NA",null,"Low","Low","84% of those alive at 2 year follow up had follow up assessments(82% of those randomised). 248 /291 in intervention group and 238/288 in placebo. \r\nNo sensitivity analysis performed. ",null,null,"N",null,"PN",null,"N","Assessments were performed by centrally trained and certified study personnel who were unaware of the treatment assignment.","NA",null,"NA",null,"Low","Low","\r\n\r\nAssessments were performed by centrally trained and certified study personnel who were unaware of the treatment assignment.\r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was in protocol documentation and is unlikely to have been selected on the basis of results. ","PN","This outcome was noted to be prespecified. ","PN","mean and SD were reported","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was in protocol documentation and is unlikely to have been selected on the basis of results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/13 15.31","MUR2008C1","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Death after randomisation","Death up to 5 years","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",">90% follow up at 2 years","NA",null,"NA",null,"NA",null,"Low","Low",">90% follow up at 2 years\r\n\r\n\r\n",null,null,"N","Objective outcome. ","N",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Objective outcome. \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","Death was a prespecified outcome in the trial registration. Although SAP was not reviewed, those analyses that were not prespecified were noted in the methods and an interim analysis was reviewed by an independent data safety monitoring board. ","N",null,"PN",null,"Low","Low","Death was a prespecified outcome in the trial registration. Although SAP was not reviewed, those analyses that were not prespecified were noted in the methods and an interim analysis was reviewed by an independent data safety monitoring board. \r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains\r\n"]
["2022/01/14 16.40","MUR2008C2","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Neurodevelopmental impairment at early childhood","neurologic 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,"Y","91% of children were followed up for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","91% of children were followed up for this outcome. \r\n\r\n\r\n",null,null,"N","Assessment of the outcome was by a standardised neurological examination and standardised cognitive testing.","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 of the outcome was by a standardised neurological examination and standardised cognitive testing.\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","Outcome definition prespecified in registration document prior to follow up study. ","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 definition prespecified in registration document prior to follow up study. \r\n",null,null,"Low","Low","Low risk of bias for all domains\r\n"]
["2022/01/14 16.40","MUR2008C3","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Survival free of neurodevelopmental impairment at early childhood",null,"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","91% of infants were followed up for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","91% of infants were followed up for this outcome. \r\n\r\n\r\n",null,null,"N","Assessment of the outcome was by a standardised neurological examination and standardised cognitive testing.  ","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 of the outcome was by a standardised neurological examination and standardised cognitive testing.  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.   ","N","Outcome definition prespecified in registration document prior to follow up study. ","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.   ",null,null,"Low","Low","Low risk of bias for all domains\r\n"]
["2022/01/14 16.40","MUR2008C5","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Cerebral palsy","CP (any)","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","91% of infants were followed up for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","91% of infants were followed up for this outcome. \r\n\r\n\r\n",null,null,"N","Outcome was assessed by a standardised 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 standardised 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","Definition of cerebral palsy was standard. ","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.   ",null,null,"Low","Low","Low risk of bias for all domains\r\n"]
["2022/01/14 16.40","MUR2008C6","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Developmental delay or intellectual impairment at early childhood","cognitive delay","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,"PY","86% of infants who were alive had an assessment for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","86% of infants who were alive at follow up had an assessment for this outcome. \r\n\r\n\r\n",null,null,"N","Assessment of the outcome was by standardised cognitive testing. Most were assessed using Bayley scales of infant development. ","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 of the outcome was by standardised cognitive testing. Most were assessed using Bayley scales of infant development. \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","Definition of MDI <70 stated 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\nDefinition of MDI <70 stated in trial registration document. \r\n",null,null,"Low","Low","Low risk of bias for all domains\r\n"]
["2022/01/14 16.40","MUR2008H1","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Child behaviour ","Abnormal behaviour by BRS (BSID II)","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","80% of those randomised who were still alive had an assessment of this outcome. ","PN",null,"PY",null,"PN",null,"Some concerns","Some concerns","80% of those randomised who were still alive had an assessment of this outcome. \r\n\r\n\r\n",null,null,"N","Assessed using the behaviour rating scale in the Bayley scales of infant development. ","PN",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Assessed using the behaviour rating scale in the Bayley scales of infant development. \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","The level used to define nonoptimal or within normal limits was not specified. ","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\nThe level used to define nonoptimal or within normal limits was not specified. \r\n",null,null,"Some concerns","Some concerns","Some concerns due to missing data, as only 80% of those randomised who were still alive had an assessment of this outcome. "]
["2022/01/14 16.40","MUR2008H3","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,"PY",">90% follow up. ","NA",null,"NA",null,"NA",null,"Low","Low",">90% follow up. ",null,null,"N","Method of measurement by clinical 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","Method of measurement by clinical 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","Outcome definition prespecified 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\n",null,null,"Low","Low","Low risk of bias for all domains\r\n"]
["2022/01/14 16.40","MUR2008H4","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,"PY",">90% follow up. ","NA",null,"NA",null,"NA",null,"Low","Low",">90% follow up. \r\n\r\n\r\n",null,null,"N","Method of measurement by clinical 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","Method of measurement by clinical 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","Outcome definition prespecified 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\n\r\n",null,null,"Low","Low","Low risk of bias for all domains\r\n"]
["2022/01/14 16.44","MUR2008H9","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Any respiratory disease ","Respiratory infection","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. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. \r\n\r\n\r\n\r\nIntention to treat analysis was used. \r\n",null,null,"PY",">90% follow up. ","NA",null,"NA",null,"NA",null,"Low","Low",">90% follow up. \r\n\r\n\r\n",null,null,"PN","Method of measurement not stated but unlikely to have differed between groups due to blinding. ","PN",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Method of measurement not stated but unlikely to have differed between groups due to blinding. \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 not 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",null,"PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was not 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\r\n"]
["2022/01/14 16.46","MUR2008N1","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","growth measurements at early childhood","growth measurements at early childhood","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,"PY","Data available for 88% of those randomised. ","NA",null,"NA",null,"NA",null,"Low","Low","Data available for 88% of those randomised. \r\n\r\n\r\n",null,null,"N","Method of measurement not stated but likely standard methods were used. ","PN",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Method of measurement not stated but likely standard methods were used. \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 prespecified 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\n",null,null,"Low","Low","Low risk of bias for all domains\r\n"]
["2022/01/14 16.46","MUR2008K1","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Hospital re-admission at childhood follow-up","hospitalisation since first discharge","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,"PY","Over 90% follow up at 2 years .","NA",null,"NA",null,"NA",null,"Low","Low","Over 90% follow up at 2 years .\r\n\r\n\r\n",null,null,"N","Obtained from clinical records/participant history. ","PN",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Obtained from clinical records/participant history. \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 not 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 not 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\r\n"]
["2022/01/14 10.04","TEA1999C1","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","Death (after randomisation)",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY","Limited information but based on registration document and trial centre likely performed with random sequence generation and allocation concealment. ","NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not performed as the trial was stopped early and not published. \r\n",null,null,"Y","Missing data for 3/94 (3.2%) in both groups.","NA",null,"NA",null,"NA",null,"Low","Low","Missing data for 3/94 (3.2%) in both groups.\r\n\r\n\r\n",null,null,"PN","Objective outcome. ","PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","Objective outcome. \r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished trial data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished trial data were included. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/13 10.23","TEA1999C2","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","Neurodevelopmental impairment at early childhood",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY","Limited information but based on registration document and trial centre likely performed with random sequence generation and allocation concealment. ","NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not performed as the trial was stopped early and not published. \r\n",null,null,"N","Only 68% of those randomised had data for this outcome. No sensitivity analysis performed. ","N",null,"PY",null,"PY",null,"High","High","Only 68% of those randomised had data for this outcome. No sensitivity analysis performed. It is likely missingness of data could depend on its outcome. \n\n\n",null,null,"PN","Developmental assessment by Bayley Scales of infant development specified in registration document.  ","PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","Developmental assessment by Bayley Scales of infant development specified in registration document.  \r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished trial data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished trial data were included. ",null,null,"High","High","High risk as only 68% of those randomised had data for this outcome. No sensitivity analysis performed. "]
["2022/01/13 10.25","TEA1999C3","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","Survival free of neurodevelopmental impairment at early childhood",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY","Limited information but based on registration document and trial centre likely performed with random sequence generation and allocation concealment. ","NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not performed as the trial was stopped early and not published. \r\n",null,null,"PN","data on neurodevelopmental outcome only available for 68%. ","PN",null,"PY",null,"PY",null,"High","High","data on neurodevelopmental outcome only available for 68%. \r\n\r\n\r\n",null,null,"PN","Developmental assessment by Bayley Scales of infant development specified in registration document.  ","PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","Developmental assessment by Bayley Scales of infant development specified in registration document.  \r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished trial data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished trial data were included. ",null,null,"High","High","High risk as only 68% of those randomised had data for neurodevelopmental impairment. No sensitivity analysis performed. "]
["2021/10/12 09.41","TEA1999C5","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","Cerebral palsy",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY","Limited information but based on registration document and trial centre likely performed with random sequence generation and allocation concealment. ","NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not performed as the trial was stopped early and not published. \r\n",null,null,"N","68% of those randomised had data for this outcome. ","N",null,"PY","Similar levels of missing data in both groups. ","PY",null,"High","High","68% of those randomised had data for this outcome. \r\n\r\nSimilar levels of missing data in both groups. \r\n",null,null,"PN",null,"PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","\r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished trial data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished trial data were included. ",null,null,"High","High","Only 68% of those randomised had data for this outcome. Similar proportion of missing data in both groups. Overall high risk as missing data may be more likely to include those with the outcome of cerebral palsy."]
["2021/10/12 09.42","TEA1999H3","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","Deafness",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY","Limited information but based on registration document and trial centre likely performed with random sequence generation and allocation concealment. ","NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not performed as the trial was stopped early and not published. \r\n",null,null,"PN","68% of those randomised had data for this outcome. ","N","No sensitivity analysis. ","PY",null,"PN",null,"Some concerns","Some concerns","68% of those randomised had data for this outcome. \r\nNo sensitivity analysis. \r\n\r\n",null,null,"PN",null,"PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","\r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished trial data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished trial data were included. ",null,null,"Some concerns","Some concerns","68% of those randomised had data for this outcome but outcome unlikely to be influenced by missingness of data.  No sensitivity analysis. "]
["2022/01/10 11.36","TEA1999H4","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","Blindness/visual impairment",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY","Limited information but based on registration document and trial centre likely performed with random sequence generation and allocation concealment. ","NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not performed as the trial was stopped early and not published. \r\n",null,null,"PN","68% of those randomised had data for this outcome. ","N","No sensitivity analysis. ","PY",null,"PN",null,"Some concerns","Some concerns","68% of those randomised had data for this outcome.  No sensitivity analysis. \r\n\r\n\r\n",null,null,"PN",null,"PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","\r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished trial data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished trial data were included. ",null,null,"Some concerns","Some concerns","68% of those randomised had data for this outcome but outcome unlikely to be influenced by missingness of data.  No sensitivity analysis. "]

{"sheet":"Summary","index":2,"n_rows":11,"n_cols":27,"rows_kept":11,"cut":false,"hidden":false,"merged":[]}
["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"]

{"sheet":"Figure (PP)","index":4,"n_rows":1,"n_cols":13,"rows_kept":1,"cut":false,"hidden":false,"merged":[]}
["Per-protocol","Unique ID","Study ID","Experimental","Comparator","Outcome","Weight","D1","D2","D3","D4","D5","Overall"]

{"sheet":"Print (ITT)","index":5,"n_rows":0,"n_cols":0,"rows_kept":0,"cut":false,"hidden":false,"merged":[]}

{"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"]

{"sheet":"Print_format (PP)","index":8,"n_rows":32,"n_cols":6,"rows_kept":32,"cut":false,"hidden":true,"merged":[[18,5,19,5],[24,5,25,5],[4,1,4,3],[5,0,8,0],[5,1,5,3],[5,5,6,5],[6,1,6,3],[7,1,7,3],[8,1,8,3],[9,5,10,5],[10,1,10,3],[11,1,11,3],[12,1,12,3],[13,1,13,3],[9,0,15,0],[9,1,9,3],[14,1,14,3],[15,1,15,3],[16,0,20,0],[16,1,16,3],[17,1,17,3],[18,1,18,3],[20,1,20,3],[19,1,19,3],[31,1,31,3],[21,0,26,0],[21,1,21,3],[22,1,22,3],[26,1,26,3],[23,1,23,3],[25,1,25,3],[24,1,24,3],[29,1,29,3],[27,0,30,0],[27,1,27,3],[28,1,28,3],[30,1,30,3]]}
["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"]