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Table 2 Risk of bias in individual studies evaluating the effect of glucocorticosteroids for acute pancreatitis

From: Corticosteroid treatment for acute/acute-on-chronic experimental and naturally occurring pancreatitis in several species: a scoping review to inform possible use in dogs

Study Study species Study design LOE I–IV Group similarity (good, fair, poor) Estimated risk of bias (high, moderate, low) Support for Risk of bias judgement Group size
Okanishi et al. [57] Dogs Non-randomised controlled trial III Good (age, sex, breed, diagnosis incl clinical signs + spec-cPLI or plasma lipase, ultrasound, CRP. Baseline variables were similar between groups Moderate Selection bias: Non-concealed, non-randomised allocation of participants to GC group 2011–2014, non-GC group 2015–2016. Breeds and ages in groups were not matched. Performance bias: No blinding. V-LIP used in diagnosis is inferior to spec-cPLI. Detection bias: No blinding of outcome assessment. Statistical analysis described. 3 drop-outs excluded from relevant analysis Moderate (45/20)
Studley and Schenk [39] Experiment 1 and 2 Dogs Randomised controlled trial II Poor, age/sex/breed not stated. Diagnosis ok as histopathology confirmed induced pancreatitis Low Selection bias: Method of randomisation not described. Performance bias: No blinding, detection bias: No blinding of outcome assessment, but as outcome was survival, the lack of blinding was less worrying. No drop-outs. Stat analysis, but not described Very small (5–8)
Attix et al. [58] Dogs Controlled trial III Poor, age not stated, division of which sex into which group not stated, all “mixed-breed”, induced AP diagnosis was confirmed by histopathology High Selection bias: No randomisation/concealment. Performance bias: No blinding of personnel performing subjective clinical evaluation and histopathology. Detection bias: no blinding of outcome assessment. Reporting bias: clinical and pathologic features were to be compared for GC treated and non-GC treated, no results for histopathology were reported. No drop-outs, no statistics Very small (4/4)
Stewart et al. [59] Dogs Controlled trial III Poor, age not stated, division of which sex into which group not stated, all “mixed-breed”, induced AP diagnosis was confirmed by histopathology High Selection bias: no randomisation/concealment. Performance: No blinding. Detection bias: No blinding of outcome assessment, however, survival is an objective parameter, histopathology less so. 3 cortisone treated died of GI ulceration biasing the mortality rates. No drop-outs, no statistics Moderate/small (25/16)
Imahori et al. [60] Dogs Controlled trial III Poor, age and sex not stated, all “mixed-breed”, induced AP diagnosis was confirmed by histopathology Low (High for electron microscopy) Selection bias: No randomisation/concealment. Blinded histopathologist. No drop-outs, statistics but not explained Study 1 small (14/14), study 2 very small (5/6)
Kaplan et al. [65] Humans Retrospective case–control study III Fair, AP diagnosis by clinical signs and plasma amylase, age and sex stated High Selection bias: No randomisation/concealment. No standardisation among groups in diagnostics or treatments. Performance bias: No blinding of personnel or participants. Variation in dose and timing of GC and other treatment. High incidence of gall bladder disease. Detection bias: no blinding of outcome assessment. No drop-outs, no statistics Small (15/48)
Liu et al. [40] Humans Randomised controlled trial II Poor, AP diagnosis by clinical diagnosis (not further elaborated), age and sex of patients not mentioned Moderate Selection bias: Method of randomisation not described. Detection bias: Lack of blinding of outcome assessment seems irrelevant, as outcome is mortality. Other bias: Salviae Miltiorrhiza and Dextran was given with GC. In 2 of the 3 deaths in GC group, early preventive treatment was delayed till 3 days after onset of disease. No drop-outs, statistics explained Moderate (26/53)
Eklund et al. [37] Humans Retrospective case–control study III Good, AP diagnosis by clinical signs, amylase and CT, age and sex distribution similar among groups Low Selection bias: Only patients with severe acute pancreatitis requiring norepinephrine support for hemodynamic shock were included. Performance bias and detection bias: No blinding, but outcomes CRP and mortality are objective parameters. Other comments: Cause of AP: Alcohol 7, gallstones 3, unusual causes for dogs, should be considered when results are extrapolated for dogs. No drop-outs, statistics Small (10/11)
Wang et al. [66] Humans Case-series IV Fair: AP diagnosis by clinical signs, amylase and ultrasound, CT, age and sex stated High Performance and detection bias: No blinding of participants or personnel, who evaluated pain. Reporting bias: Comparison of mortality with literature is questionable. Other bias: Dextran 40 was given along with GC. No drop-outs mentioned, no statistics Moderate (32)
Wan et al. [38] Humans Randomised controlled trial II Good, AP diagnosis by clinical signs, lipase, CT, no statistical difference among groups according to sex, age, disease severity, etiology, complications Low Randomisation by SPSS software, drop-out rate not statistically significant different between groups, Performance and detection bias: no blinding stated but all parameters objective. Statistics explained Moderate (43/38)
Zhang et al. [41] Rats Randomised controlled trial II Good, healthy, all male, similar weight rats Moderate Selection bias: Method of randomisation not described. Performance and detection bias: No blinding of histopathologist stated, but semiquantative grading of histopathologic findings. Attrition bias: histopathology score of 2 rats from control group was not available due to their death at 12 h. No other drop-outs, statistics explained Moderate (45/45)
Schulz et al. [42] Rats Randomised controlled trial II Good, all male, similar weight rats Low Selection bias: Method of randomisation not described. Blinded histopathologist, semiquantative grading of histopathology findings, no drop-outs, statistics explained Small (15/15)
Gloor et al. [61] Rats Controlled trials III Good, all female, similar weight rats Low Selection bias: No randomisation stated, blinded histopathologists, semiquantative grading of histopathology findings, no drop-outs, no statistics on histopathology, but statistics on mortality Moderate (32/32)
Moderate (40/40)
Moderate/very small (21/8)
Cosen-Binker et al. [43] Rats Randomised controlled trial II Good, pathogen-free, all male similar weight rats Moderate Selection bias: Method of randomisation not described. Blinded histopathologists, semiquantative grading of histopathological findings, no drop-outs. Reporting bias: Unclear description of results: GC “did not present much improvement”, although results are marked by P < 0,001. Results and statistics not adequately explained Small (16/16/16)
Cosen-Binker et al. [44] Rats Randomised controlled trial II Good, pathogen-free, all male similar weight rats Low Selection bias: Method of randomisation not described. Blinded histopathologists, semiquantative grading of histopathology findings, no drop-outs. Reporting bias: Authors state that treatment 4 h post induction is harmful, but results put these in the same disease category as controls. Statistics Small (16/16/16/16)
Jha et al. [45] Rats Randomised controlled trial II Good, all male similar weight rats High Selection bias: Method of randomisation not described. Blinded histopathologist. Reporting bias: No results of histopathology score or TEM shown, only photo examples with conclusions, no statistics on histopathology score of GC group or TEM. No drop-outs Moderate (24/24)
Melo et al. [46] Rats Randomised controlled trial III Good, all male similar weight rats Low Selection bias: Randomisation not stated. Blinded histopathologist, semiquantative grading of histopathology findings, no drop-outs, statistics Very small (8/8)
Ramudo et al. [62] Rats Controlled trial III Good, all male similar weight rats Moderate Selection bias: No randomisation stated. Blinded histopathologists, semiquantative grading of histopathology findings, no drop-outs, statistics Very small (6/6)
Ramudo et al. [47] Rats Randomised controlled trial II Good, all male similar weight rats Low Selection bias: Method of randomisation not described. Blinded histopathologists, semiquantative grading of histopathology findings, no drop-outs, statistics Unknown, group sizes not stated
Ou et al. [48] Rats Randomised controlled trial II Good, clean grade, all male similar weight rats High Selection bias: Method of randomisation not described. Performance and detection bias: Blinding not stated. Reporting bias: Results of “pathological severity score” are concluded upon, but their definition is not explained. No drop-outs, statistics Moderate (36/36)
Zhao et al. [49] Rats Randomised controlled trial II Good, all male similar weight and age High Selection bias: Method of randomisation not described. Performance, detection and reporting bias: Blinding of histopathologist(s) was not stated, no scoring technique described, histopathology results not shown, but conclusions were stated. No research question about histopathology, no statistics on histopathology, no drop-outs Small (15/15)
Foitzik et al. [50] Rats Randomised controlled trial II Good, all male similar weight rats Moderate Selection bias: Method of randomisation not described. Performance and detection bias: Blinding of histopathologist(s) was not stated, semiquantitative histopathology scoring was done, Possible attrition bias: histopathological analysis included only those animals that survived the whole experiment. Statistics Small (10/10/12/10)
Biradar and Veeresh 2012 [51] Rats Randomised controlled trial II Good, all male similar weight rats High Selection bias: Method of randomisation not described. Blinded histopathologist. Reporting bias: GC not in the research question, used as positive control, no results or conclusion for CRP shown, no results for histopathology score shown, but conclusions stated. No drop-outs, no statistics Very small (6/6)
Biradar and Veeresh [52] Rats Randomised controlled trial II Good, all male similar weight rats High Selection bias: Method of randomisation not described. Blinded histopathologist. Reporting bias: GC not in the research question, used as pos control, no results or conclusion for CRP shown, no results for histopathology score shown, but conclusions stated. No drop-outs, no statistics Very small (8/8)
Duan et al. [63] Rats Controlled trial III Good, all male similar weight and age rats Moderate Selection bias: Randomisation not stated, only relevant parameter was mortality, which makes the lack of blinding less worrying. No drop-outs, no statistics Moderate (21/24)
Wang et al. [36] Rats Randomised controlled trial II Good, all male similar weight rats Moderate Selection bias: Method of randomisation not described. Blinded histopathologists. Reporting bias: Results for histopathology were not shown, but concluded upon. No drop-outs, statistics Moderate (25/25)
Liu et al. [53] Rats Randomised controlled trial II Fair, rats of similar weight, otherwise not described Low Selection bias: Method of randomisation not described. Blinded histopathologists. Performance bias: The type of glucocorticoid was not specified making the dose hard to evaluate. No drop-outs, statistics Small (16/16)
Sha et al. [54] Rats Randomised controlled trial II Good, all male similar weight rats Low Selection bias: Method of randomisation not described. Blinded histopathologist. Reporting bias: Results are shown for histopathology score and there are conclusions and statistical analysis. For TEM no results are shown, but conclusions are made. No drop-outs Moderate (24/24)
Kilic et al. [55] Rats Randomised controlled trial II Good, rats aged 7–8 months, similar weight Low Selection bias: Method of randomisation not described. Blinding, histopathology scoring system, clear results and statistical evaluation, research question was answered. No drop-outs Very small (8/8)
Cui et al. [56] Rats Randomised controlled trial II Good, all male, similar age and weight High Selection bias: Method of randomisation not described. Performance, detection and reporting bias: No blinding, no stated histopathology scoring system, no statistical evaluation, seems to be conclusions based on subjective evaluation. No drop-outs Very small (6/6)
Zhao et al. [64] Mice Controlled trial III Good, all male, similar age mice of 2 genotypes High Selection bias: No randomisation stated. Performance, detection and reporting bias: No blinding stated, histopathological changes of the pancreas was not included in the aims, but shown by photos and not commented on. Mortality rate was included in the aims, results provided, but no statistical evaluation was done. No drop-outs Small (15/20/34)
  1. The table displays the study designs and the estimated risk of bias in individual studies referred to in the review. The individual studies were graded for level of evidence (LOE) on a scale of I to IV, the group similarity was rated good, fair or poor and study group size was graded as good, moderate, small or very small