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[null,"Instructions for the assessment form",null,null,null,null,"Instructions for the summary",null,null,null,null,"Instructions for the figure",null,null,null,null,"Instructions for generating a print view",null,null,null,null,"Instructions for the discrepancy check"]

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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"]
["2021/06/24 08.58","De Vos 2014",null,"De Vos 2014",null,"SCS + other","other alone","Pain dichotmous, short term","RR 13.50 (1.97, 92.30)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,null,"PY","Y","\"The randomization was a block stratified randomization per centre, as 1 centre included 24 patients and the other centres included between 2 and 13 patients. Randomization and  data  management  were  performed  by  an  independent  third party.\"\r\n\r\nComment: specific method of randomisation not described but likely to be random.","N","No baseline imbalances apparent","Low","Low",null,null,null,"Y","Y","Open-label study.","NI","No clear information regarding details of deviations or the medical management provided.","NA",null,"NA",null,"Y","ITT analysis used with any loss treated as non responder","NA",null,"Some concerns","Some concerns",null,null,null,"PN","3 (7.5%) did not complete in SCS group, and 0 in CMM group.","Y","Missing data treated as non-responders. Access to full data, shared by study authors suggests no substantial impact of missing data.","NA",null,"NA",null,"Low","Low","There may not be a high risk here as level of missing data low, ITT analysis performed and amount of missing data balanced between groups. Missing data treated as non-responders.",null,null,"N","Participant self-report using validated scales.","PN","Open label study with subjective outcomes and a complex experimental intervention.","Y","Open-label study","Y","Open-label study of a complex experimental intervention.","Y",null,"High","High",null,null,null,"NI","No protocol or SAP published.","N",null,"PY",null,"Some concerns","Some concerns",null,null,null,"High","High"]
["2021/06/24 08.58","SENZA-PDN","NOC","SENZA-PDN",null,"HF-SCS+CMM","CMM alone","Pain, 50% responder","RR: 7.14 (3.39-15.06)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"          Journal article(s) with results of the trial;          Trial protocol;          Statistical analysis plan (SAP);          Non-commercial trial registry record (e.g. ClinicalTrials.gov record);          Conference abstract(s) about the trial","Y","Y","Paper: \"Treatment allocations were concealed with computer assignment 1:1 to CMM or 10-kHz SCS plusCMM.Randomization was performed using a random-sized block method by site and stratified by pain severity (VAS) and glycemic control (HbA1c)....\"\r\nProtocol: \"“Concealed allocation will be achieved via computer assignment of the treatment arm, and investigational site staff and study sponsor personnel will be unaware of the block size and randomization list.”\r\n","N","No apparent baseline differences.","Low","Low",null,null,null,"Y","Y","Open label study","NI","No information provided about CMM delivered in either group.","NA",null,"NA",null,"PY","labelled an ITT approach (though a number of post randomisation exclusions occurred in the SCS arm.)","NA",null,"Some concerns","Some concerns",null,null,null,"N","Post randomisation exclusions took place prior to pre-implantation trial period and were omitted from the analysis. In total at 1 month there are 16% of randomised participants excluded from the SCS group and 9% from the CMM group ","PN","While sensitivity analyses are presented they don't account for all exclusions and while statistical significance would likely be unchanged the effect size is likely to be affected.","Y","Missingness reasons could reflect intervention tolerability","Y",null,"High","High",null,null,null,"PN","Pain measured by participants using standard instruments.","PN",null,"Y","Open label study","Y","Open label study of a complex invasive intervention","Y",null,"High","High",null,null,null,"PY","While an SAP is available it is unclear whether it was finalised and unchanged ahead of the end of data collection.","PN","There is inconsistency between the precise definition of the primary outcome between the protocol and the paper and for different timepoints. Authors shared data on request","PY","Inconsistency in the N for comparisons between the flowchart and text raise this possibility. Authors shared data on request but still N inclear","High","Some concerns","While no protocol or full SAP is available sharing of the full dataset by the study authors indicates no evidence of selectivity.",null,null,"High","High"]

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

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["Studies with intention-to-treat","Unique ID","Study ID","Experimental","Comparator","Outcome","Weight","Randomization process","Deviations from intended interventions","Missing outcome data","Measurement of the outcome","Selection of the reported result","Overall",null,null,null,null,"Studies with pre-protocol","Unique ID","Study ID","Experimental","Comparator","Outcome","Weight","Randomization process","Deviations from intended interventions","Missing outcome data","Measurement of the outcome","Selection of the reported result","Overall"]

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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"]
["2021/05/02 15.24","De Vos 2014",null,"De Vos 2014",null,"SCS + other","other alone","Pain dichotmous, short term","RR 13.50 (1.97, 92.30)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,null,"Y","PY","\"...a total of 60 patients were included and, statified for sex, randomly assigned to best conventional medical practice with (SCS group) or without (control group) additional SCS therapy. The randomization was a block stratified randomization per centre, as 1 centre included 24 patients and the other centres included between 2 and 13 patients.\"\r\r\"Randomization and data management were performed by an independent third party\"","N","\"Baseline characteristics were relatively well balanced between the 2 groups, the main exceptions being a somewhat higher age and lower pain score in the control group. However, none of the differences between the groups was significant\"","Low","Low",null,"NA",null,"Y","Y","\"The present study was an open randomized parallel-group design\"","NI","No information to assess deviations from intended intervention that arose because of experimental context.\r","NA",null,"NA",null,"Y","\"An intention-to-treat analysis was performed...\"","NA",null,"Some concerns","Some concerns",null,"Favours experimental ",null,"PN","3/40 (7.5%) participants dropped out in experimental group, 0 dropouts in control group: (Note: What did we say threshold here was? If 10 percent than this can be scored as PY).","PN","Despite small percentage of missing data, LOCF was used & therefore result likely biased","Y","2/4 dropouts in experimental group because \"they did not perceive significant pain relief\".\r\rMissingness in outcome likely to have depended on its true value.","Y",null,"High","Some concerns",null,"Favours experimental ",null,"N","\"Pain scores were assessed using a VAS (with 0 representing no pain and 100 the worst pain possible)\".","PN","Outcomes recorded at each (presumably pre-specified) study visit. No flowchart demonstrating process for outcome ascertainment.","Y","\"The present study was an open randomized parallel-group design.\"","Y","Knowledge of the assigned intervention was likely to influence self-report pain intensity levels.\r\rParticipants were likely to have strong beliefs in beneficial effects of the intervention and it is likely that the outcome was influenced by the knowledge of the intervention received.","Y",null,"High","High",null,"Favours experimental ",null,"PY","The study was registered at the Dutch Trial Register (ISRCTN03269533), however, there was no analysis plan reported in register.","PN","No evidence of numerical result being selected on basis of results from multiple elgibile outcome measurements.","PN","No evidence of numerical result being selected on basis of results from multiple eligible analyses of data","Low","Some concerns",null,"Favours experimental ",null,"High","High",null,"Favours experimental "]
["2021/05/25 08.09","SENZA-PDN","MCF","SENZA-PDN",null,"HF-SCS+CMM","CMM alone","Pain, 50% responder",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"        Journal article(s) with results of the trial;        Trial protocol;        Statistical analysis plan (SAP);        Non-commercial trial registry record (e.g. ClinicalTrials.gov record);        Conference abstract(s) about the trial","Y","Y","Paper: \"Treatment allocations were concealed with computer assignment 1:1 to CMM or 10-kHz SCS plusCMM.Randomization was performed using a random-sized block method by site and stratified by pain severity (VAS) and glycemic control (HbA1c)....\"\rProtocol: \"“Concealed allocation will be achieved via computer assignment of the treatment arm, and investigational site staff and study sponsor personnel will be unaware of the block size and randomization list.”\r","N","No apparent baseline differences.","Low","Low",null,null,null,"Y","Y","Open-label","NI","No information to assess whether there were deviations from the intended intervention that arose because of experimental context","NA",null,"NA",null,"PN","ITT used but not all subjects accounted for in analyses","PY","As a true ITT was not used, it is possible that there is potential for impact on results as a result of analysis methods","High","High",null,null,null,"PN","15% missing data in SCS group, 9% in control","PN","Authors reported that impact of missing data were examined in sensitivity analyses and that best/worse case scenario imputations made no impact on primary/secondary conclusions. As data for these analyses was not presented, it is not possible to make an objective judgement.","PY","Participants experiencing worse outcomes more likely to dropout","PY",null,"High","High",null,null,null,"PN","Pain measured by participants using standard instruments.","PN",null,"Y","Open label study","Y","Open label study of a complex invasive intervention","Y",null,"High","High",null,null,null,"PN","While an SAP is available it is unclear whether it was finalised and unchanged ahead of the end of data collection.","PN","Conflicting pre-specified vs reported outcomes, however authors shared data","PY","While authors shared data on request, they were analysed using a questionable ITT analysis and N of participants analysed are discrepant with those randomised","High","High",null,null,null,null,"High"]

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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) with results of the trial","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 non- protocol 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 experimental 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, UKRI Gateway to Research)"]
[null,"Personal communication with trialist"]
[null,"Personal communication with the sponsor"]