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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"]

{"sheet":"Results","index":1,"n_rows":3,"n_cols":85,"rows_kept":3,"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. 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 13.47","PROCESS",null,"PROCESS",null,"SCS + other","other alone","adverse events long term",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"             Journal article(s) with results of the trial;             Trial protocol;             Non-commercial trial registry record (e.g. ClinicalTrials.gov record);             Conference abstract(s) about the trial","Y","Y","\"Eligible patients were randomly assigned in a 1:1 ratio to conventional medical management with SCS (SCS group) or without SCS (CMM group). A biostatistician prepared random computer-generated blocks (random sequence of either 2 or 4 patients) on a per site basis...The randomisation was electronically locked and could only be accessed after a patient entered the trial.\"\r\r","PN","Note: Back pain higher in SCS group (SCS 54.5 (24.3 : CMM 44.8 (23.2)\rHigher history of litigation in CMM group (17% VS 10% IN SCS) but likely compatible with chance.\r","Low","Low",null,null,null,"Y","Y","Open-label study.","Y","By 12 months 28 (58%) in the CMM group had crossed to SCS. 5 (9.6%) in SCS group had crossed to CMM. No information about CMM delivered in either group.\r","Y",null,"N","By 12 months 28 (58%) in the CMM group had crossed to SCS. 5 (9.6%) in SCS group had crossed to CMM. ","Y","While 12 month primary analysis is per protocol, data are presented for an ITT analysis with crossover classified as non-responders. Those data were used in our calculation of this result.","NA",null,"High","High",null,null,null,"PN","Missing data at this time point (SCS 6/52 (11.5%, CMM 7/48 14.5%)","N","Analysis based on available data excluding loss to follow up.","PY","Reasons for loss to follow-up/ withdrawn consent not reported but likely.","PY",null,"High","High",null,null,null,"NI","Minimal information reported about specifics of measurement","N",null,"Y","Open label study.","Y","Open label study of an invasive intervention with a subjective outcome.","PN",null,"Some concerns","High","Limited information on how AEs were classified and the approach taken to surveillance which may impact on the reported values.",null,null,"PY","Reported analysis aligns with that in published protocol and reported for this time-point.","PN","No clear indication of inappropriate selection of result","PN","No clear indication of selection from mutliple analyses","Low","Low",null,null,null,"High","High"]

{"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"]

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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"]
["2021/05/09 13.26","PROCESS","MCF","PROCESS",null,"SCS + other","other alone","adverse events",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"  Journal article(s) with results of the trial;  Trial protocol;  Non-commercial trial registry record (e.g. ClinicalTrials.gov record);  Conference abstract(s) about the trial","Y","Y","\"Eligible patients were randomly assigned in a 1:1 ratio to conventional medical management with SCS (SCS group) or without SCS (CMM group). A biostastistician\" prepared random computer-generated blocks (random requence of either 2 or 4 patients) on a per site basis.\"\r\r\"The randomisation was electronically locked and could only be accessed after a patient entered the trial\"/","PN","Back pain higher in SCS group (SCS 54.5 (24.3) vs CMM 44.8 (23.2)). Higher history of litigation in CMM group (CMM group 17% vs 10% SCS).","Low","Low","Note for discussion: Do these baseline differences actually suggest a problem in randomisation? My thoughts are no.","NA",null,"Y","Y","\"Given the nature of the intervention, it was impossible to blind patients and difficult to blind investigators during the trial\".","NI","Note for discussion: \"at baseline, the non-SCS therapy received by both groups was reviewed and actively managed, at the discretion of the study investigator and according to to local clinical practice.\" It is difficult to judge whether the active management of non-SCS therapy would have affected the outcome of interest. I cannot find any other reported information to help inform this judgement.","NA",null,"NA",null,"Y","\"...the primary (between group) analysis of all outcomes was performed at 6-months follow up and according to the intention-to-treat (ITT) principle.\"","NA",null,"Some concerns","Some concerns",null,null,null,"N","9% missing in SCS group; 14% missing in CMM group.","PN","There is no evidence to suggest the result was not biased by missing outcome data.","Y","Missingness in outcome may depend on true value.\r\rParticipants experiencing worse outcomes more likely to drop out.\r\rLikely that participants that experienced worse outcomes dropped out from 12 month follow up.\r\r","Y",null,"High","High",null,"Favours experimental ",null,"NI","\"The nature and frequency of adverse treatment-related events and complications were documented, and the Adverse Events Committee adjudicated all events.\"","PN","No evidence to suggest ascertainment of outcomes differed between groups/","Y","Open-label","Y","Reporting of \"other\" AEs could be influenced by knowledge of intervention received.\r\rReporting of \"other\" AEs likely to be influenced by knowledge of intervention received.","Y",null,"High","High",null,"Favours experimental ",null,"NI","Limited information for pre-planned statistical analysis, primary outcome and method of analysis seems to have been adhered to.","PN","Outcome was prespecified in the study trial registry report and the study protocol.","PN","No evidence to suggest result was selected on basis of results from multiple eligible analyses of the data.","Some concerns","Some concerns",null,"NA",null,"High","High",null,"Favours experimental "]

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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"]