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[null,null,null,null,null,null,null,"V9 update:"]
[null,null,null,null,null,null,null,"*Add a new button in Summary tab to synchronize results between Results and Summary tabs"]
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[null,null,null,null,null,null,null,"V8 update:"]
[null,null,null,null,null,null,null,"*Added judgement-level comment in the summary table"]
[null,null,null,null,null,null,null,"*Removed \"Double click on this column…\" label in the comments after enter"]
[null,null,null,null,null,null,null,"*Corrected spelling mistakes"]

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["Basic information",null,null,null,null,null,null,null,null,null,null,null,null,"Domain 1. Randomization process",null,null,null,null,null,null,null,null,null,"Domain 2. Deviations from intended interventions",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Domain 3. 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"]
["2022.08.31 08.33","Eeg-Olofsson_duration to liberation from MV","KD","Eeg-Olofsson 2022",null,"Early tracheostomy","Late tracheostomy","Duration to liberation MV","MD  −8.03 (−13.85;−2.27), p=0.0064","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","NI","\"The patients who were included underwent randomized stratifcation with the allocation to either early (seven days after intubation or less) or late tracheotomy (ten days after intubation or more) in groups of four depending on sex and age (male<65  years, male≥65  years, female<65  years and female≥65  years). Te reason for the diferent strata was because there was an anticipated irregularity in the cohort with a predominance of males,\n65  years of age or older\"","N",null,"Some concerns","Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n",null,null,"N","Y","\"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"","NA",null,"NA",null,null,null,"NA",null,"NA",null,"Low","Low","single-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n",null,null,"Y","ITT data was available for all patients, ","NA",null,"NA",null,"NA",null,"Low","Low","ITT data was available for all patients, \r\n\r\n\r\n",null,null,"N","the method of measuring the outcome was not inappropriate: objective documentation of ventilation status","N","unlikely that objective documentation of ventilation status would have differed between intervention groups","Y","single-blinded study: only patients blinded; Outcome assessors were aware of intervention received ","PN","it is unlikely that assessment of the outcome would have been influenced by knowledge of the intervention received","NA",null,"Low","Low","the method of measuring the outcome was not inappropriate: objective documentation of ventilation status\r\nunlikely that objective documentation of ventilation status would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nit is unlikely that assessment of the outcome would have been influenced by knowledge of the intervention received\r\n",null,null,"PY","research protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"","N",null,"N",null,"Low","Low","research protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n",null,null,"Some concerns","Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n\r\nsingle-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n\r\nITT data was available for all patients, \r\n\r\n\r\n\r\nthe method of measuring the outcome was not inappropriate: objective documentation of ventilation status\r\nunlikely that objective documentation of ventilation status would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nit is unlikely that assessment of the outcome would have been influenced by knowledge of the intervention received\r\n\r\nresearch protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n"]
["2022.08.31 08.33","Eeg-Olofsson_ICU LoS","KD","Eeg-Olofsson 2022",null,"Early tracheostomy","Late tracheostomy","ICU length of stay","MD  −6.67 (−13.64; 0.23), p=0.059","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","NI","\"The patients who were included underwent randomized stratifcation with the allocation to either early (seven days after intubation or less) or late tracheotomy (ten days after intubation or more) in groups of four depending on sex and age (male<65  years, male≥65  years, female<65  years and female≥65  years). Te reason for the diferent strata was because there was an anticipated irregularity in the cohort with a predominance of males,\r\n65  years of age or older\"","N",null,"Some concerns","Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n",null,null,"N","Y","\"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"","NA",null,"NA",null,null,null,"NA",null,"NA",null,"Low","Low","single-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n",null,null,"Y","ITT data was available for all patients","NA",null,"NA",null,"NA",null,"Low","Low","ITT data was available for all patients\r\n\r\n\r\n",null,null,"N","the method of measuring the outcome was not inappropriate: objective documentation of hospitalization status","N","unlikely that objective documentation of hospitalization status would have differed between intervention groups","Y","single-blinded study: only patients blinded; Outcome assessors were aware of intervention received ","PN","it is unlikely that assessment of the outcome would have been influenced by knowledge of the intervention received","NA",null,"Low","Low","the method of measuring the outcome was not inappropriate: objective documentation of hospitalization status\r\nunlikely that objective documentation of hospitalization status would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nit is unlikely that assessment of the outcome would have been influenced by knowledge of the intervention received\r\n",null,null,"PY","research protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"","N",null,"N",null,"Low","Low","research protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n",null,null,"Some concerns","Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n\r\nsingle-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n\r\nITT data was available for all patients\r\n\r\n\r\n\r\nthe method of measuring the outcome was not inappropriate: objective documentation of hospitalization status\r\nunlikely that objective documentation of hospitalization status would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nit is unlikely that assessment of the outcome would have been influenced by knowledge of the intervention received\r\n\r\nresearch protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n"]
["2022.08.31 08.33","Eeg-Olofsson_overall mortality","KD","Eeg-Olofsson 2022",null,"Early tracheostomy","Late tracheostomy","overall mortality (death in ICU)","MD −16.7 (−40.3; 9.0); p = 0.3","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","NI","\"The patients who were included underwent randomized stratifcation with the allocation to either early (seven days after intubation or less) or late tracheotomy (ten days after intubation or more) in groups of four depending on sex and age (male<65  years, male≥65  years, female<65  years and female≥65  years). Te reason for the diferent strata was because there was an anticipated irregularity in the cohort with a predominance of males,\r\n65  years of age or older\"","N",null,"Some concerns","Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n",null,null,"N","Y","\"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"","NA",null,"NA",null,null,null,"NA",null,"NA",null,"Low","Low","single-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n",null,null,"Y","ITT data was available for all patients","NA",null,"NA",null,"NA",null,"Low","Low","ITT data was available for all patients\r\n\r\n\r\n",null,null,"N","the method of measuring the outcome was not inappropriate: objective documentation of death","N","unlikely that objective documentation of death would have differed between intervention groups","Y","single-blinded study: only patients blinded; Outcome assessors were aware of intervention received ","PN","it is unlikely that assessment of the outcome would have been influenced by knowledge of the intervention received","NA",null,"Low","Low","the method of measuring the outcome was not inappropriate: objective documentation of death\r\nunlikely that objective documentation of death would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nit is unlikely that assessment of the outcome would have been influenced by knowledge of the intervention received\r\n",null,null,"PY","research protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"","N",null,"N",null,"Low","Low","research protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n",null,null,"Some concerns","Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n\r\nsingle-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n\r\nITT data was available for all patients\r\n\r\n\r\n\r\nthe method of measuring the outcome was not inappropriate: objective documentation of death\r\nunlikely that objective documentation of death would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nit is unlikely that assessment of the outcome would have been influenced by knowledge of the intervention received\r\n\r\nresearch protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n"]
["2022.08.31 08.33","Eeg-Olofsson_adverse events","KD","Eeg-Olofsson 2022",null,"Early tracheostomy","Late tracheostomy","any complications","MD   −8.9 (−28.1; 7.8), p=0.46","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","NI","\"The patients who were included underwent randomized stratifcation with the allocation to either early (seven days after intubation or less) or late tracheotomy (ten days after intubation or more) in groups of four depending on sex and age (male<65  years, male≥65  years, female<65  years and female≥65  years). Te reason for the diferent strata was because there was an anticipated irregularity in the cohort with a predominance of males,\r\n65  years of age or older\"","N",null,"Some concerns","Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n",null,null,"N","Y","\"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"","N",null,"NA",null,"NA",null,"Y","\" This interim analysis was performed according to both the ITT and the PP principles. \"","NA",null,"Low","Low","single-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n",null,null,"Y","ITT data was available for all patients","NA",null,"NA",null,"NA",null,"Low","Low","ITT data was available for all patients\r\n\r\n\r\n",null,null,"N","the method of measuring the outcome was not inappropriate: documentation of complications","PN","unlikely that documentation of complications would have differed between intervention groups","Y","single-blinded study: only patients blinded; Outcome assessors were aware of intervention received ","PY","Assessment of the intervention could have been influenced by knowledge of intervention received","PN",null,"Some concerns","Some concerns","the method of measuring the outcome was not inappropriate: documentation of complications\r\nunlikely that documentation of complications would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nAssessment of the intervention could have been influenced by knowledge of intervention received\r\n",null,null,"PY","research protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"","N",null,"N",null,"Low","Low","research protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n",null,null,"Some concerns","Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n\r\nsingle-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n\r\nITT data was available for all patients\r\n\r\n\r\n\r\nthe method of measuring the outcome was not inappropriate: documentation of complications\r\nunlikely that documentation of complications would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nAssessment of the intervention could have been influenced by knowledge of intervention received\r\n\r\nresearch protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n"]
["2022.08.31 08.34","Eeg-Olofsson_tracheal bleeding","KD","Eeg-Olofsson 2022",null,"Early tracheostomy","Late tracheostomy","tracheal bleeding","MD   −1.3 (−23.1; 21.3), p= 1","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","NI","\"The patients who were included underwent randomized stratifcation with the allocation to either early (seven days after intubation or less) or late tracheotomy (ten days after intubation or more) in groups of four depending on sex and age (male<65  years, male≥65  years, female<65  years and female≥65  years). Te reason for the diferent strata was because there was an anticipated irregularity in the cohort with a predominance of males,\r\n65  years of age or older\"","N",null,"Some concerns","Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n",null,null,"N","Y","\"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"","N",null,"NA",null,"NA",null,"Y","\" This interim analysis was performed according to both the ITT and the PP principles. \"","NA",null,"Low","Low","single-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n",null,null,"Y","ITT data was available for all patients","NA",null,"NA",null,"NA",null,"Low","Low","ITT data was available for all patients\r\n\r\n\r\n",null,null,"N","the method of measuring the outcome was not inappropriate: documentation of complications","PN","unlikely that documentation of complications would have differed between intervention groups","Y","single-blinded study: only patients blinded; Outcome assessors were aware of intervention received ","PY","Assessment of the intervention could have been influenced by knowledge of intervention received","PN",null,"Some concerns","Some concerns","the method of measuring the outcome was not inappropriate: documentation of complications\r\nunlikely that documentation of complications would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nAssessment of the intervention could have been influenced by knowledge of intervention received\r\n",null,null,"PY","research protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"","N",null,"N",null,"Low","Low","research protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n",null,null,"Some concerns","Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n\r\nsingle-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n\r\nITT data was available for all patients\r\n\r\n\r\n\r\nthe method of measuring the outcome was not inappropriate: documentation of complications\r\nunlikely that documentation of complications would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nAssessment of the intervention could have been influenced by knowledge of intervention received\r\n\r\nresearch protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n"]
["2022.08.31 08.34","Eeg-Olofsson_airway obstruction","KD","Eeg-Olofsson 2022",null,"Early tracheostomy","Late tracheostomy","airway obstruction","MD   13.4 (−5.3; 34.5), p=0.27","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","NI","\"The patients who were included underwent randomized stratifcation with the allocation to either early (seven days after intubation or less) or late tracheotomy (ten days after intubation or more) in groups of four depending on sex and age (male<65  years, male≥65  years, female<65  years and female≥65  years). Te reason for the diferent strata was because there was an anticipated irregularity in the cohort with a predominance of males,\r\n65  years of age or older\"","N",null,"Some concerns","Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n",null,null,"N","Y","\"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"","N",null,"NA",null,"NA",null,"Y","\" This interim analysis was performed according to both the ITT and the PP principles. \"","NA",null,"Low","Low","single-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n",null,null,"Y","ITT data was available for all patients","NA",null,"NA",null,"NA",null,"Low","Low","ITT data was available for all patients\r\n\r\n\r\n",null,null,"N","the method of measuring the outcome was not inappropriate: documentation of complications","PN","unlikely that documentation of complications would have differed between intervention groups","Y","single-blinded study: only patients blinded; Outcome assessors were aware of intervention received ","PY","Assessment of the intervention could have been influenced by knowledge of intervention received","PN",null,"Some concerns","Some concerns","the method of measuring the outcome was not inappropriate: documentation of complications\r\nunlikely that documentation of complications would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nAssessment of the intervention could have been influenced by knowledge of intervention received\r\n",null,null,"PY","research protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"","N",null,"N",null,"Low","Low","research protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n",null,null,"Some concerns","Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n\r\nsingle-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n\r\nITT data was available for all patients\r\n\r\n\r\n\r\nthe method of measuring the outcome was not inappropriate: documentation of complications\r\nunlikely that documentation of complications would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nAssessment of the intervention could have been influenced by knowledge of intervention received\r\n\r\nresearch protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n"]
["2022.08.31 08.35","Eeg-Olofsson_ventilator associated pneumonia","KD","Eeg-Olofsson 2022",null,"Early tracheostomy","Late tracheostomy","ventilator associated pneumonia","MD   -2.2 (−17.1; 14.3), p=1","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","NI","\"The patients who were included underwent randomized stratifcation with the allocation to either early (seven days after intubation or less) or late tracheotomy (ten days after intubation or more) in groups of four depending on sex and age (male<65  years, male≥65  years, female<65  years and female≥65  years). Te reason for the diferent strata was because there was an anticipated irregularity in the cohort with a predominance of males,\r\n65  years of age or older\"","N",null,"Some concerns","Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n",null,null,"N","Y","\"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"","N",null,"NA",null,"NA",null,"Y","\" This interim analysis was performed according to both the ITT and the PP principles. \"","NA",null,"Low","Low","single-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n",null,null,"Y","ITT data was available for all patients","NA",null,"NA",null,"NA",null,"Low","Low","ITT data was available for all patients\r\n\r\n\r\n",null,null,"N","the method of measuring the outcome was not inappropriate: documentation of complications","PN","unlikely that documentation of complications would have differed between intervention groups","Y","single-blinded study: only patients blinded; Outcome assessors were aware of intervention received ","PY","Assessment of the intervention could have been influenced by knowledge of intervention received","PN",null,"Some concerns","Some concerns","the method of measuring the outcome was not inappropriate: documentation of complications\r\nunlikely that documentation of complications would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nAssessment of the intervention could have been influenced by knowledge of intervention received\r\n",null,null,"PY","research protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"","N",null,"N",null,"Low","Low","research protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n",null,null,"Some concerns","Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n\r\nsingle-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n\r\nITT data was available for all patients\r\n\r\n\r\n\r\nthe method of measuring the outcome was not inappropriate: documentation of complications\r\nunlikely that documentation of complications would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nAssessment of the intervention could have been influenced by knowledge of intervention received\r\n\r\nresearch protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n"]

{"sheet":"Summary","index":2,"n_rows":11,"n_cols":33,"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","Comment for randomization process","Deviations from intended interventions","Comment for deviations from intended interventions","Missing outcome data","Comment for missing outcome data","Measurement of the outcome","Comment for measurement of the outcome","Selection of the reported result","Comment for selection of the reported result","Overall Bias","Comment for 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"]
["Eeg-Olofsson_duration to liberation from MV","KD","Eeg-Olofsson 2022",null,"Early tracheostomy","Late tracheostomy","Duration to liberation MV","MD  −8.03 (−13.85;−2.27), p=0.0064","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n","Low","single-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n","Low","ITT data was available for all patients, \r\n\r\n\r\n","Low","the method of measuring the outcome was not inappropriate: objective documentation of ventilation status\r\nunlikely that objective documentation of ventilation status would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nit is unlikely that assessment of the outcome would have been influenced by knowledge of the intervention received\r\n","Low","research protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n","Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n\r\nsingle-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n\r\nITT data was available for all patients, \r\n\r\n\r\n\r\nthe method of measuring the outcome was not inappropriate: objective documentation of ventilation status\r\nunlikely that objective documentation of ventilation status would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nit is unlikely that assessment of the outcome would have been influenced by knowledge of the intervention received\r\n\r\nresearch protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n",null,null,null,"Assignment to intervention (the 'intention-to-treat' effect)"]
["Eeg-Olofsson_ICU LoS","KD","Eeg-Olofsson 2022",null,"Early tracheostomy","Late tracheostomy","ICU length of stay","MD  −6.67 (−13.64; 0.23), p=0.059","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n","Low","single-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n","Low","ITT data was available for all patients\r\n\r\n\r\n","Low","the method of measuring the outcome was not inappropriate: objective documentation of hospitalization status\r\nunlikely that objective documentation of hospitalization status would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nit is unlikely that assessment of the outcome would have been influenced by knowledge of the intervention received\r\n","Low","research protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n","Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n\r\nsingle-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n\r\nITT data was available for all patients\r\n\r\n\r\n\r\nthe method of measuring the outcome was not inappropriate: objective documentation of hospitalization status\r\nunlikely that objective documentation of hospitalization status would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nit is unlikely that assessment of the outcome would have been influenced by knowledge of the intervention received\r\n\r\nresearch protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n",null,null,null,"Total number of study = 7"]
["Eeg-Olofsson_overall mortality","KD","Eeg-Olofsson 2022",null,"Early tracheostomy","Late tracheostomy","overall mortality (death in ICU)","MD −16.7 (−40.3; 9.0); p = 0.3","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n","Low","single-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n","Low","ITT data was available for all patients\r\n\r\n\r\n","Low","the method of measuring the outcome was not inappropriate: objective documentation of death\r\nunlikely that objective documentation of death would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nit is unlikely that assessment of the outcome would have been influenced by knowledge of the intervention received\r\n","Low","research protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n","Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n\r\nsingle-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n\r\nITT data was available for all patients\r\n\r\n\r\n\r\nthe method of measuring the outcome was not inappropriate: objective documentation of death\r\nunlikely that objective documentation of death would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nit is unlikely that assessment of the outcome would have been influenced by knowledge of the intervention received\r\n\r\nresearch protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n",null,null,null,"Low risk",0,100,100,42.9,100,0]
["Eeg-Olofsson_adverse events","KD","Eeg-Olofsson 2022",null,"Early tracheostomy","Late tracheostomy","any complications","MD   −8.9 (−28.1; 7.8), p=0.46","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n","Low","single-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n","Low","ITT data was available for all patients\r\n\r\n\r\n","Some concerns","the method of measuring the outcome was not inappropriate: documentation of complications\r\nunlikely that documentation of complications would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nAssessment of the intervention could have been influenced by knowledge of intervention received\r\n","Low","research protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n","Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n\r\nsingle-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n\r\nITT data was available for all patients\r\n\r\n\r\n\r\nthe method of measuring the outcome was not inappropriate: documentation of complications\r\nunlikely that documentation of complications would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nAssessment of the intervention could have been influenced by knowledge of intervention received\r\n\r\nresearch protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n",null,null,null,"Some concerns",100,0,0,57.1,0,100]
["Eeg-Olofsson_tracheal bleeding","KD","Eeg-Olofsson 2022",null,"Early tracheostomy","Late tracheostomy","tracheal bleeding","MD   −1.3 (−23.1; 21.3), p= 1","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n","Low","single-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n","Low","ITT data was available for all patients\r\n\r\n\r\n","Some concerns","the method of measuring the outcome was not inappropriate: documentation of complications\r\nunlikely that documentation of complications would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nAssessment of the intervention could have been influenced by knowledge of intervention received\r\n","Low","research protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n","Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n\r\nsingle-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n\r\nITT data was available for all patients\r\n\r\n\r\n\r\nthe method of measuring the outcome was not inappropriate: documentation of complications\r\nunlikely that documentation of complications would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nAssessment of the intervention could have been influenced by knowledge of intervention received\r\n\r\nresearch protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n",null,null,null,"High risk",0,0,0,0,0,0]
["Eeg-Olofsson_airway obstruction","KD","Eeg-Olofsson 2022",null,"Early tracheostomy","Late tracheostomy","airway obstruction","MD   13.4 (−5.3; 34.5), p=0.27","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n","Low","single-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n","Low","ITT data was available for all patients\r\n\r\n\r\n","Some concerns","the method of measuring the outcome was not inappropriate: documentation of complications\r\nunlikely that documentation of complications would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nAssessment of the intervention could have been influenced by knowledge of intervention received\r\n","Low","research protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n","Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n\r\nsingle-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n\r\nITT data was available for all patients\r\n\r\n\r\n\r\nthe method of measuring the outcome was not inappropriate: documentation of complications\r\nunlikely that documentation of complications would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nAssessment of the intervention could have been influenced by knowledge of intervention received\r\n\r\nresearch protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n",null,null,null,"Adhering to intervention (the 'per-protocol' effect)"]
["Eeg-Olofsson_ventilator associated pneumonia","KD","Eeg-Olofsson 2022",null,"Early tracheostomy","Late tracheostomy","ventilator associated pneumonia","MD   -2.2 (−17.1; 14.3), p=1","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n","Low","single-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n","Low","ITT data was available for all patients\r\n\r\n\r\n","Some concerns","the method of measuring the outcome was not inappropriate: documentation of complications\r\nunlikely that documentation of complications would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nAssessment of the intervention could have been influenced by knowledge of intervention received\r\n","Low","research protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n","Some concerns","The patients who were included underwent randomized stratifcation \r\nno information regarding allocation concealment\r\n\r\nsingle-blinded study: \"Patients were blinded to the study assignment due to the required anaesthesia while intubated and mechanically ventilated.\"\r\n\r\n\r\n\r\n\" This interim analysis was performed according to both the ITT and the PP principles. \"\r\n\r\nITT data was available for all patients\r\n\r\n\r\n\r\nthe method of measuring the outcome was not inappropriate: documentation of complications\r\nunlikely that documentation of complications would have differed between intervention groups\r\nsingle-blinded study: only patients blinded; Outcome assessors were aware of intervention received \r\nAssessment of the intervention could have been influenced by knowledge of intervention received\r\n\r\nresearch protocol: \"Mann Whitney U-test (non-parametric) will be used to compare both the primary and secondary outcome measures (categorical data) between treatment arms.\"\r\n\r\n",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,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,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,null,null,null,null,null,null,"High risk"]

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["Per-protocol","Unique ID","Study ID","Experimental","Comparator","Outcome","Weight","D1","D2","D3","D4","D5","Overall"]

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["Intention-to-treat","Unique ID","Study ID","Experimental","Comparator","Outcome","Weight","D1","D2","D3","D4","D5","Overall"]
[null,"Eeg-Olofsson_duration to liberation from MV","Eeg-Olofsson 2022","Early tracheostomy","Late tracheostomy","Duration to liberation MV",1,null,null,null,null,null,null,null,null,"Low risk"]
[null,"Eeg-Olofsson_ICU LoS","Eeg-Olofsson 2022","Early tracheostomy","Late tracheostomy","ICU length of stay",1,null,null,null,null,null,null,null,null,"Some concerns"]
[null,"Eeg-Olofsson_overall mortality","Eeg-Olofsson 2022","Early tracheostomy","Late tracheostomy","overall mortality (death in ICU)",1,null,null,null,null,null,null,null,null,"High risk"]
[null,"Eeg-Olofsson_adverse events","Eeg-Olofsson 2022","Early tracheostomy","Late tracheostomy","any complications",1]
[null,"Eeg-Olofsson_tracheal bleeding","Eeg-Olofsson 2022","Early tracheostomy","Late tracheostomy","tracheal bleeding",1,null,null,null,null,null,null,null,"D1","Randomisation process"]
[null,"Eeg-Olofsson_airway obstruction","Eeg-Olofsson 2022","Early tracheostomy","Late tracheostomy","airway obstruction",1,null,null,null,null,null,null,null,"D2","Deviations from the intended interventions"]
[null,"Eeg-Olofsson_ventilator associated pneumonia","Eeg-Olofsson 2022","Early tracheostomy","Late tracheostomy","ventilator associated pneumonia",1,null,null,null,null,null,null,null,"D3","Missing outcome data"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,"D4","Measurement of the outcome"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,"D5","Selection of the reported result"]

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{"sheet":"Check","index":7,"n_rows":0,"n_cols":0,"rows_kept":0,"cut":false,"hidden":false,"merged":[]}

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

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

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[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"]