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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":7,"n_cols":85,"rows_kept":7,"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"]
["2021/06/08 09.37","de Vos 2014",null,"de Vos 2014","de Vos 2014","SCS + other","other alone","Pain, continuous, medium term","-36 (-46.84, -25.15)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"              Journal article(s) with results of the trial;              Non-commercial trial registry record (e.g. ClinicalTrials.gov record);              Conference abstract(s) about the trial","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 information about conventional medical management delivered in each arm.","NA",null,"NA",null,"PY","ITT analysis used though appears to use LOCF for missing data.","NA",null,"Some concerns","Some concerns",null,null,null,"N","4 (10%) did not complete in SCS group, and 2 (10%) in CMM group.","Y","Missing data imputed using last observation carried forward. However raw data shared by authors suggests minimal impact","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. Raw data does not indicate important bias.",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 published protocol or SAP.","N","Outcome reporting consistent and complete.","N","No indication of selection from mutliple analyses.","Some concerns","Low"," 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"]
["2021/06/08 09.32","PROCESS",null,"PROCESS","PROCESS","SCS + other","other alone","Pain, continuous, medium term","-26.7 (-36.87, -16.53)","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\n\r\n","PN","Note: Back pain higher in SCS group (SCS 54.5 (24.3 : CMM 44.8 (23.2)\r\nHigher history of litigation in CMM group (17% VS 10% IN SCS) but likely compatible with chance.\r\n","Low","Low",null,null,null,"Y","Y","Open-label study.","NI","Note: Prior to 6 month follow up crossing between groups was not permitted. At this time point withdrawal was low (4% in SCS group, 8% in CMM group). No information about CMM delivered in either group.","NA",null,"NA",null,"Y","ITT analysis. Primary analysis used available data, sensitivity analysis imputed using LOCF approach, though level of missing data low.","NA",null,"Some concerns","Some concerns",null,null,null,"Y","Low levels of missing data at this time point (SCS 4%, CMM 8%)","NA",null,"NA",null,"NA",null,"Low","Low",null,null,null,"PN","Use of VAS. Note: anchors for pain scale not specified","PN",null,"Y","Open label study.","Y","Open label study of a complex, invasive intervention","Y",null,"High","High",null,null,null,"PY","Reported analysis aligns with that in published protocol and reported for this time-point.","PN","Outcomes reported consistent with protocol","PN","No indication of selection from multiple analyses","Low","Low",null,null,null,"High","High"]
["2021/06/24 11.57","PROMISE",null,"PROMISE","PROMISE","SCS + other","other alone","Pain, continuous, medium term","-12 (-17.31,-6.69)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"      Journal article(s) with results of the trial;      Trial protocol;      Conference abstract(s) about the trial","Y","Y","\"Patients were randomly allocated (1:1 ratio) to SCS1OMM (SCS group) or OMM alone (OMM group) using random, permuted blocks of 4 and 2 stratified by investigational site.\"\r\r\"To maintain allocation concealment, randomization assignments were provided using an electronic data management system.\"\r\r","PN","Difference in % unable to work: SCS+OMM=58.2%, OMM=43.5% but compatible with chance","Low","Low",null,null,null,"Y","Y","Open- label study","NI","Differences between groups in the degree of other invasive therapies received though potentially consistent with what might be expected clinically.  No information provided to assess deviations in the medical management across groups.\r\r","NA",null,"NA",null,"Y","ITT analysis reported.","NA",null,"Some concerns","Some concerns",null,null,null,"PN","16% discontinuations in the SCS group and 3% in OMM group. It is not clear how many of these continued to provide data and how many were missing.","PY","BOCF conservative as compared with per protocol or completers analysis.","NA",null,"NA",null,"Low","Some concerns","While BOCF is conservstive there remains a possibility that thr effect estimate differs from the true effect.",null,null,"N","Pain measured by participant using accepted scales","N",null,"Y","Open-label study","Y","Open label study of complex invasive intervention","Y",null,"High","High",null,null,null,"Y","Reporting and analyses consistent with protocol","PN","Reporting of results for this outcome appears complete and unselective.","PN","Primary analysis is ITT","Low","Low","Reporting of results for this outcome appears complete and unselective.",null,null,"High","High"]
["2021/06/24 12.38","Kemler 2000",null,"Kemler 2000",null,"SCS + other","other alone","Pain continuous","-34 (-48.17, -19.83","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"    Journal article(s) with results of the trial","Y","PY","\"Randomly assigned in a 2:1 ratio to receive treatment with spinal cord stimulation and a standardized physical-therapy program or with the standardized physical-therapy program alone. A computer generated table of random numbers was used to make the treatment assignments, with stratification according to the location of the reflex sympathetic dystrophy (hand or foot). \r\rThe assignments were made by a research assistant and were concealed from the study investigators.\"","PN","Some gender imbalance (SCS + PT 61%F, PT 83%F) but compatible with chance.","Low","Low",null,null,null,"Y","Y","Open label study","NI","No information on the details of the physical therapy delivered","NA",null,"NA",null,"Y","ITT analysis employed.","NA",null,"Some concerns","Some concerns",null,null,null,"PY","Only 1 participant reported LTFU in PT only group","NA",null,"NA",null,"NA",null,"Low","Low",null,null,null,"N","Pain measured using standard scales, participants rated their own pain","PN",null,"Y","Open label study","Y","Open label study of complex, invasive intervention","Y",null,"High","High",null,null,null,"NI","No registry record, protocol or SAP available.","PN","No indication of selective reporting","PN","No indication of selection from multiple analyses","Some concerns","Some concerns",null,null,null,"High","High"]
["2021/06/24 08.57","SENZA-PDN Cont","MCF","SENZA-PDN",null,"HF-SCS+CMM","CMM alone","Pain continuous",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)....\"\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","NI","No information to assess whether there were deviations from the intended intervention that arose because of experimental context","NA",null,"NA",null,"PY","ITT used though  all subjects accounted for in analyses","NA",null,"Some concerns","Some concerns",null,null,null,"PN","15% missing data in SCS group, 9% in control","PN","BOCF used but not on full ITT cohort and with post randomisation exclusions.","Y",null,"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,"PY","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","Some concerns",null,null,null,null,"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"]
["2021/05/02 15.16","de Vos 2014",null,"de Vos 2014","de Vos 2014","SCS + other","other alone","Pain, continuous, medium term","-36 (-46.84, -25.15)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"  Journal article(s) with results of the trial;  Non-commercial trial registry record (e.g. ClinicalTrials.gov record);  Conference abstract(s) about the trial","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","4/40 participants dropped out in experimental group, 2/20 dropped out in control group","PN","Despite small proportions of missing data and comparability between groups, LOCF was used to deal with missing data.","Y","2/4 dropouts in experimental group dropped out 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 "]
["2021/05/02 13.46","PROCESS",null,"PROCESS","PROCESS","SCS + other","other alone","Pain, continuous, medium term","-26.7 (-36.87, -16.53)","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,"PN","2 participants did not provide 6-month data in SCS group in 4 participants did not provide 6-month data in CMM group. LOCF used to impute missing values","PN","Higher proportion of missing 6-month data in CMM group and use of LOCF indicates outcome may be biased by missing outcome data.","PY","Participants who do not experience adequate in pain relief in CMM group more likely to drop out.\r\r\r","PY",null,"High","High",null,null,null,"N","\"We used patient self-completed questionnaires. During four days preceding a study visit, pain intensity was assessed by the patient in a \"pain diary\" (recording the VAS three times per day separately for back pain and leg pain). Pain data were expressed as absolute values...\"","N","There is no evidence to suggest measurement of the outcome differed between intervention groups.","Y","Self-report outcome measures; participants aware of intervention received.","Y","Knowledge of the intervention received is likely to influence self-report pain intensity levels.\r\rParticipants were likely to have had strong beliefs in the 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","Limited information for pre-planned statistical analysis, method of analysis seems to have been adhered to.","PN","Outomce was prespecified in the study trial registry report and the study protocol.","N","Outcome adjusted for baseline score as specified in protocol.","Low","Low",null,"NA",null,"High","High",null,"Favours experimental "]
["2021/05/02 13.57","PROMISE",null,"PROMISE","PROMISE","SCS + other","other alone","Pain, continuous, medium term","-12 (-17.31,-6.69)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"  Journal article(s) with results of the trial;  Trial protocol;  Conference abstract(s) about the trial","PY","PY","\"Patients were randomly allocated (1:1 ratio) to SCS10MM (SCS group) or OMM alone (OMM group) using random, permuted blocks of 4 and 2 stratified by investigational site.\"\rProtocol: \"To minimise selection bias, randomization numbers will be assigned in strict sequence; that is, when a subject is confirmed as eligible for randomization, the next unassigned randomization number in sequence will be given. Permuted blocks will be used to generate the randomization assignments, in order to keep the balance of patients receiving each treatment assignment and help prevent the next treatment group from being discerned by site personnel.\"\r\r\"To maintain allocation concealment, randomization assignments were provided using an electronic data management system.\"\rProtocol: \"Randomization allocation will be concealed from the clinician and patient, using a centralized automatic web-based data management system.\"","PN","Some difference in percentage of participants unable to work (SCS+OMM 58.2%, OMM 43.5%).","Low","Low",null,null,null,"Y","Y","\"Due to the nature of the treatments, the treating phyicians and patients could not be blinded to the treatment group.\"","NI","\"The OMM treatment plan was developed for each patient and optimized at each visit\", which may have resulted in deviations that arose because of the experimental context, however there is no information to suggest this was the case.","NA",null,"NA",null,"Y","\"For primary and secondary objectives at 6 months, the primary analysis followed the ITT principle.\"\r\"The ITT analysis consisted of all patients according to the randomization allocation.\"","NA",null,"Some concerns","Some concerns",null,null,null,"N","16% missing in SCS group vs 3% missing in OMM group.","PN","Patients with missing data were treated as no change for secondary objectives for the ITT analysis (note: check if same as ITT?)","Y","Patients who did not responded/worsened with SCS would have been more likely to dropout and not provide outcome data.","Y",null,"High","High",null,null,null,"N","Back & leg pain meausred with NPRS ","PN","No evidence to suggest measurement or ascertainment of the outcome different between the intervention groups.","Y","Self-report; \"Due to the nature of the treatments, the treating physicians and patients could not be blinded to the treatment group.\"","Y","\"The lack of blinding makes assessment susceptible to assessment bias and placebo and nocebo effects.\"\r\rKnowledge of receiving SCS is likely to influence the assessment of outcome.","Y",null,"High","High",null,null,null,"Y","Protocol provides detailed analysis plan, published before unblinded outcome data were available for analysis.","N","NPRS at 6 months analyses pre-specified in protocol and used in published report.","PN","Only adjusted scores reported in published report.","Low","Low",null,null,null,"High","High"]
["2021/05/02 15.19","Kemler 2000",null,"Kemler 2000",null,"SCS + other","other alone","Pain continuous","-34 (-48.17, -19.83","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"    Journal article(s) with results of the trial","Y","Y","\"A computer generated table of tandom numbers was used to make the treatment assignments, with stratification according to the location of the reflex sympathetic dystrophy (hand or foot). The assignments were made by a research assistant and were concealed by the study investigators.\"","N","Minor imbalance between sexes; not indicative of problem with randomization process.","Low","Low",null,"NA",null,"Y","Y","Open-label","NI","No information to suggest there were or were not deviations from the intended intervention that arose because of the experimental context","NA",null,"NA",null,"Y","Intention-to-treated analysis conducted.","NA",null,"Some concerns","Some concerns",null,"Favours experimental ",null,"Y","No missing data reported.","NA",null,"NA",null,"NA",null,"Low","Low",null,"NA",null,"N","Pain intensity meausred with visual analogue scale.","PN","Baseline measurements between groups may have different slightly; unlikely to have affected 6-month between-group change data.","Y","Self-report outcome; open-label study.","Y","Knowledge of intervention received may influence pain intensity scores.\r\rParticipants likely to have strong belief in beneficial effects of intervention; likley to influence assessment of outcome.",null,null,"High","High",null,"Favours experimental ",null,"PN","There is no trial protocol or SAP for this study. (note: also no evidence to suggest analysis was performed with unblinded data)","PN","This result is unlikely to have been selected on the basis of results from multiple eligible outcome measurements.","PN","This result is unlikely to have been selected on the basis of results from multiple eligible analyses of data.","Some concerns","Some concerns",null,"Favours experimental ",null,"High","High",null,"Favours experimental "]
["2021/05/02 14.53","SENZA-PDN",null,"SENZA-PDN",null,"SCS + other","other alone","Pain continuous","-52 (-57.57, -46.43)","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","\"Treatment allocations were conealed with computer assignment 1:1 to CMM or 10-kHz SCS plus CMM. Randomization was performed using a random-sized block method by site and stratified by pain intensity (VAS) and glycemic control (HbA1c).\"","N","No baseline differences noted.","Low","Low",null,"NA",null,"Y","Y","Open-label. \r\"Comparing an implanted medical device with best available medical treatment made blinding impossible.\"","NI","No information to suggest that there were or were not deviations from the intended intervention that rose because of the experimental context.","NA",null,"NA",null,"PN","\"Beyond primary end point analysis of the intention-to-treat population, outcomes are reported for the per-protocol population as means with 95% CIs\"","PY","Per protocol analysis likely used instead of ITT; denominator in both groups does not account for all participants randomised.","High","High",null,"Favours experimental ",null,"PN","~25% missing data for SCS group; ~10% missing in CMM group","N","Method of dealing with missing data unclear; does not seem to be multiple imputation as per SAP.","Y","Participants without relief are more likely to be lost to follow up.\r\rIt is likely that missingness of outcome data were due to pain intensity values.","PY",null,"High","High",null,"Favours experimental ",null,"N","VAS is a valid method of measuring pain intensity.","PN","Outcome likely to have been ascertained at the same time points and with same methods between groups.","Y","Self-response outcome; open-label study","Y","Knowledge of having received SCS could influence outcome assessment.\r\rIt is likely that knowledge of having received SCS would have influenced outcome.","Y",null,"High","High",null,"Favours experimental ",null,"Y","Intention to analyse 6-month continuous pain intensity data reported in both Protocol & SA as tertiary outcome","PN","Only one analysis for 6-month continuous data was prespecified; appropriate data reported in published article.","PN","6-month continuous data unlikely to have been selectively reported.","Low","Low",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"]