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Research

Effectiveness of disseminating consensus management recommendations for ulcer bleeding: a cluster randomized trial

Alan N. Barkun, Mamatha Bhat, David Armstrong, Martin Dawes, Allan Donner, Robert Enns, Janet Martin, Paul Moayyedi, Joseph Romagnuolo and Larry Stitt
CMAJ February 19, 2013 185 (3) E156-E166; DOI: https://doi.org/10.1503/cmaj.120095
Alan N. Barkun
From the Divisions of Gastroenterology (Barkun, Bhat), Clinical Epidemiology (Barkun) and Family Medicine (Dawes), McGill University Health Centre, McGill University, Montréal, Que.; the Division of Gastroenterology (Armstrong, Moayyedi), McMaster University, Hamilton, Ont.; the Department of Epidemiology and Biostatistics and Robarts Clinical Trials (Donner, Stitt), Robarts Research Institute, University of Western Ontario, London, Ont.; the Division of Gastroenterology (Enns), University of British Columbia, Vancouver, BC; the Departments of Anesthesia & Perioperative Medicine and Epidemiology & Biostatistics (Martin), University of Western Ontario, London, Ont.; and the Division of Gastroenterology and Hepatology (Romagnuolo), Medical University of South Carolina, Charleston, South Carolina.
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  • For correspondence: alan.barkun@muhc.mcgill.ca
Mamatha Bhat
From the Divisions of Gastroenterology (Barkun, Bhat), Clinical Epidemiology (Barkun) and Family Medicine (Dawes), McGill University Health Centre, McGill University, Montréal, Que.; the Division of Gastroenterology (Armstrong, Moayyedi), McMaster University, Hamilton, Ont.; the Department of Epidemiology and Biostatistics and Robarts Clinical Trials (Donner, Stitt), Robarts Research Institute, University of Western Ontario, London, Ont.; the Division of Gastroenterology (Enns), University of British Columbia, Vancouver, BC; the Departments of Anesthesia & Perioperative Medicine and Epidemiology & Biostatistics (Martin), University of Western Ontario, London, Ont.; and the Division of Gastroenterology and Hepatology (Romagnuolo), Medical University of South Carolina, Charleston, South Carolina.
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David Armstrong
From the Divisions of Gastroenterology (Barkun, Bhat), Clinical Epidemiology (Barkun) and Family Medicine (Dawes), McGill University Health Centre, McGill University, Montréal, Que.; the Division of Gastroenterology (Armstrong, Moayyedi), McMaster University, Hamilton, Ont.; the Department of Epidemiology and Biostatistics and Robarts Clinical Trials (Donner, Stitt), Robarts Research Institute, University of Western Ontario, London, Ont.; the Division of Gastroenterology (Enns), University of British Columbia, Vancouver, BC; the Departments of Anesthesia & Perioperative Medicine and Epidemiology & Biostatistics (Martin), University of Western Ontario, London, Ont.; and the Division of Gastroenterology and Hepatology (Romagnuolo), Medical University of South Carolina, Charleston, South Carolina.
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Martin Dawes
From the Divisions of Gastroenterology (Barkun, Bhat), Clinical Epidemiology (Barkun) and Family Medicine (Dawes), McGill University Health Centre, McGill University, Montréal, Que.; the Division of Gastroenterology (Armstrong, Moayyedi), McMaster University, Hamilton, Ont.; the Department of Epidemiology and Biostatistics and Robarts Clinical Trials (Donner, Stitt), Robarts Research Institute, University of Western Ontario, London, Ont.; the Division of Gastroenterology (Enns), University of British Columbia, Vancouver, BC; the Departments of Anesthesia & Perioperative Medicine and Epidemiology & Biostatistics (Martin), University of Western Ontario, London, Ont.; and the Division of Gastroenterology and Hepatology (Romagnuolo), Medical University of South Carolina, Charleston, South Carolina.
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Allan Donner
From the Divisions of Gastroenterology (Barkun, Bhat), Clinical Epidemiology (Barkun) and Family Medicine (Dawes), McGill University Health Centre, McGill University, Montréal, Que.; the Division of Gastroenterology (Armstrong, Moayyedi), McMaster University, Hamilton, Ont.; the Department of Epidemiology and Biostatistics and Robarts Clinical Trials (Donner, Stitt), Robarts Research Institute, University of Western Ontario, London, Ont.; the Division of Gastroenterology (Enns), University of British Columbia, Vancouver, BC; the Departments of Anesthesia & Perioperative Medicine and Epidemiology & Biostatistics (Martin), University of Western Ontario, London, Ont.; and the Division of Gastroenterology and Hepatology (Romagnuolo), Medical University of South Carolina, Charleston, South Carolina.
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Robert Enns
From the Divisions of Gastroenterology (Barkun, Bhat), Clinical Epidemiology (Barkun) and Family Medicine (Dawes), McGill University Health Centre, McGill University, Montréal, Que.; the Division of Gastroenterology (Armstrong, Moayyedi), McMaster University, Hamilton, Ont.; the Department of Epidemiology and Biostatistics and Robarts Clinical Trials (Donner, Stitt), Robarts Research Institute, University of Western Ontario, London, Ont.; the Division of Gastroenterology (Enns), University of British Columbia, Vancouver, BC; the Departments of Anesthesia & Perioperative Medicine and Epidemiology & Biostatistics (Martin), University of Western Ontario, London, Ont.; and the Division of Gastroenterology and Hepatology (Romagnuolo), Medical University of South Carolina, Charleston, South Carolina.
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Janet Martin
From the Divisions of Gastroenterology (Barkun, Bhat), Clinical Epidemiology (Barkun) and Family Medicine (Dawes), McGill University Health Centre, McGill University, Montréal, Que.; the Division of Gastroenterology (Armstrong, Moayyedi), McMaster University, Hamilton, Ont.; the Department of Epidemiology and Biostatistics and Robarts Clinical Trials (Donner, Stitt), Robarts Research Institute, University of Western Ontario, London, Ont.; the Division of Gastroenterology (Enns), University of British Columbia, Vancouver, BC; the Departments of Anesthesia & Perioperative Medicine and Epidemiology & Biostatistics (Martin), University of Western Ontario, London, Ont.; and the Division of Gastroenterology and Hepatology (Romagnuolo), Medical University of South Carolina, Charleston, South Carolina.
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Paul Moayyedi
From the Divisions of Gastroenterology (Barkun, Bhat), Clinical Epidemiology (Barkun) and Family Medicine (Dawes), McGill University Health Centre, McGill University, Montréal, Que.; the Division of Gastroenterology (Armstrong, Moayyedi), McMaster University, Hamilton, Ont.; the Department of Epidemiology and Biostatistics and Robarts Clinical Trials (Donner, Stitt), Robarts Research Institute, University of Western Ontario, London, Ont.; the Division of Gastroenterology (Enns), University of British Columbia, Vancouver, BC; the Departments of Anesthesia & Perioperative Medicine and Epidemiology & Biostatistics (Martin), University of Western Ontario, London, Ont.; and the Division of Gastroenterology and Hepatology (Romagnuolo), Medical University of South Carolina, Charleston, South Carolina.
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Joseph Romagnuolo
From the Divisions of Gastroenterology (Barkun, Bhat), Clinical Epidemiology (Barkun) and Family Medicine (Dawes), McGill University Health Centre, McGill University, Montréal, Que.; the Division of Gastroenterology (Armstrong, Moayyedi), McMaster University, Hamilton, Ont.; the Department of Epidemiology and Biostatistics and Robarts Clinical Trials (Donner, Stitt), Robarts Research Institute, University of Western Ontario, London, Ont.; the Division of Gastroenterology (Enns), University of British Columbia, Vancouver, BC; the Departments of Anesthesia & Perioperative Medicine and Epidemiology & Biostatistics (Martin), University of Western Ontario, London, Ont.; and the Division of Gastroenterology and Hepatology (Romagnuolo), Medical University of South Carolina, Charleston, South Carolina.
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Larry Stitt
From the Divisions of Gastroenterology (Barkun, Bhat), Clinical Epidemiology (Barkun) and Family Medicine (Dawes), McGill University Health Centre, McGill University, Montréal, Que.; the Division of Gastroenterology (Armstrong, Moayyedi), McMaster University, Hamilton, Ont.; the Department of Epidemiology and Biostatistics and Robarts Clinical Trials (Donner, Stitt), Robarts Research Institute, University of Western Ontario, London, Ont.; the Division of Gastroenterology (Enns), University of British Columbia, Vancouver, BC; the Departments of Anesthesia & Perioperative Medicine and Epidemiology & Biostatistics (Martin), University of Western Ontario, London, Ont.; and the Division of Gastroenterology and Hepatology (Romagnuolo), Medical University of South Carolina, Charleston, South Carolina.
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    Figure 1:

    Selection of hospitals and patients for inclusion in the trial.

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    Figure 2:

    Timetable of randomization, intervention, follow-up and data collection. Chart numbers shown do not include an additional 10% duplicate independent data entry for validation purposes. Data collection timelines were tabulated based on conservative estimates (based on pilot testing) of case volumes of 4–5 eligible patients weekly in the period of care and 4–5 charts abstracted weekly in the data collection period. The timelines allowed additional time for data collection (3–5 weeks if a 2-week turn-around was allowed for the preparation of feedback sheets).

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    Table 1:

    Patient-level analysis of compliance to guidelines for the management of nonvariceal upper gastrointestinal bleeding

    GuidelineBefore intervention, % (no. of patients)After intervention, % (no. of patients)Intracluster correlation coefficientPercentage difference (95% CI)
    Experimental groupControl groupExperimental groupControl group
    Primary outcome
    Endoscopic hemostasis followed by high-dose IV PPI13.2 (20/152)7.1 (11/155)9.8 (14/143)4.8 (6/124)0.04−5.0 (−12.0 to 2.0)
    Secondary outcomes
    Injection and/or thermal coagulation without clips and bolus IV PPI followed by infusion for 72 h for high-risk ulcers8.6 (13/152)5.2 (8/155)6.3 (9/143)4.8 (6/124)0.07−1.5 (−8.1 to 5.2)
    Injection and/or thermal coagulation with clips and bolus IV PPI followed by 8 mg/h infusion for 72 h and no oral PPI. If the patient received a pre-endoscopy infusion, the absence of bolus IV PPI was ignored69.1 (105/152)58.7 (91/155)57.3 (82/143)62.9 (78/124)0.185.6 (−12.7 to 23.8)
    Injection and/or thermal coagulation with clips and pre-endoscopy IV bolus PPI plus 80-mg bolus IV PPI followed by 8 mg/h infusion for 72 h after endoscopy and no oral PPI1.3 (2/152)1.9 (3/155)1.4 (2/143)0.8 (1/124)−0.05−0.6 (−2.5 to 1.3)
    Injection and/or thermal coagulation upon endoscopy for high-risk ulcers with clips alone81.6 (124/152)74.8 (116/155)72.7 (104/143)72.6 (90/124)0.35−0.1 (−20.4 to 20.1)
    Injection and/or thermal coagulation without clips for high-risk ulcers alone49.3 (75/152)56.1 (87/155)50.4 (72/143)46.8 (58/124)0.33−3.6 (−25.4 to 18.2)
    80-mg IV bolus PPI followed by 8 mg/h PPI infusion for 72 h after endoscopy and no oral PPI15.3 (27/177)10.0 (17/170)13.6 (21/155)15.9 (24/151)0.272.3 (−12.1 to 16.8)
    80-mg IV bolus PPI followed by 8 mg/h infusion for 72 h after endoscopy and no oral PPI. If patient received a pre-endoscopy infusion, the absence of bolus IV PPI afterward was ignored82.5 (146/177)80.0 (136/170)81.3 (126/155)89.4 (135/151)0.068.1 (−1.4 to 17.6)
    Pre-endoscopy bolus of PPI plus 80-mg bolus IV PPI followed by 8 mg/h infusion for 72 h after endoscopy and no oral PPI1.1 (2/177)1.8 (3/170)1.9 (3/155)9.3 (14/151)0.357.3 (−2.9 to 17.5)
    Use of validated scoring system based on a combination of clinical and endoscopic characteristics to stratify patients into low- and high-risk categories0.0 (0/402)0.2 (1/424)1.9 (7/361)0.0 (0/389)0.19−1.9 (−5.0 to 1.1)
    Early endoscopy (in the first 24 h) with risk classification by clinical/endoscopic criteria62.9 (253/402)65.6 (278/424)57.3 (207/361)63.1 (245/388)0.095.6 (−5.6 to 16.9)
    No hemostasis for low risk lesion88.9 (200/225)93.7 (223/238)94.2 (196/208)89.0 (218/245)0.13−5.2 (−13.2 to 2.8)
    Endoscopic hemostasis for adherent clot87.9 (29/33)88.0 (22/25)80.7 (25/31)80.8 (21/26)0.090.1 (−22.9 to 23.1)
    Endoscopic hemostasis for other active bleeding or visible vessel85.9 (152/177)83.3 (155/186)93.5 (143/153)86.1 (124/144)0.06−7.4 (−15.8 to 1.1)
    Low-risk patients who received treatment11.1 (25/225)6.3 (15/238)5.8 (12/208)11.0 (27/245)0.135.2 (−2.8 to 13.2)
    Low-risk patients not given IV PPI bolus or infusion after endoscopy61.8 (139/225)59.2 (141/238)56.3 (117/208)64.1 (157/245)0.058.0 (−2.9 to 18.9)
    • Note: CI = confidence interval, IV = intravenous, PPI = proton pump inhibitor.

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    Table 2:

    Characteristics of hospitals included in the study

    CharacteristicNo. (%)
    Experimental group
    n = 21
    Control group
    n = 22
    University hospital13 (61.9)18 (81.8)
    Availability of a nurse on call17 (81.0)17 (77.3)
    Residents assist in care of patients with upper gastrointestinal bleeding16 (76.2)16 (72.7)
    Teaching/education/administrative activities occurred at site that could alter patient management0 (0.0)1 (4.6)
    More than 400 beds14 (66.7)15 (68.2)
    Geographic location
     East*10 (47.6)7 (31.8)
     Ontario and West†11 (52.4)15 (68.2)
    • ↵* Quebec, Newfoundland, Nova Scotia, New Brunswick and Prince Edward Island.

    • ↵† British Columbia, Alberta, Saskatchewan and Manitoba.

    • View popup
    Table 3:

    Characteristics of patients with available outcome data, before and after intervention

    CharacteristicBefore intervention, % (no. of patients)*After intervention, % (no. of patients)*
    Experimental group
    n = 402
    Control group
    n = 424
    Experimental group
    n = 361
    Control group
    n = 389
    Age, yr, mean ± SD68.6 ± 15.366.3 ± 15.768.0 ± 14.867.8 ± 16.4
    Sex, male240 (59.7)274 (64.6)218 (60.4)220 (56.6)
    No. of comorbid illnesses, median (range)2.0 (0–10)2.0 (0–7)3.0 (0–8)2.0 (0–9)
    Inpatient onset of bleeding106 (26.4)58 (13.7)71 (19.7)69 (17.7)
    Rockall score recorded0 (0.0)0 (0.0)7 (1.9)0 (0.0)
    Blatchford score†0 (0.0)1 (0.2)0 (0.0)0 (0.0)
    Presence of initial hemodynamic instability110 (27.4)129 (30.4)134 (37.1)113 (29.1)
    Bleeding site: stomach211 (52.5)246 (58.0)191 (52.9)222 (57.1)
    Bleeding stigmata identified at endoscopy
    High-risk lesion177 (44.0)186 (43.9)153 (42.4)144 (37.0)
     Active bleeding75 (18.7)83 (19.6)65 (18.0)63 (16.2)
     Adherent clot48 (11.9)46 (10.9)42 (11.6)37 (9.5)
     Nonbleeding visible vessel54 (13.4)57 (13.4)46 (12.7)44 (11.3)
    Low-risk lesion225 (56.0)238 (56.1)208 (57.6)245 (63.0)
     Clean base ulcer176 (43.8)199 (46.9)182 (50.4)208 (53.5)
     Nonprotuberant pigmented dot49 (12.2)39 (9.2)26 (7.2)37 (9.5)
    • Note: SD = standard deviation.

    • ↵* Unless otherwise indicated.

    • ↵† The Blatchford score is a risk stratification scale used in the pre-endoscopic assessment of patients with upper gastrointestinal bleeding.

    • View popup
    Table 4:

    Clinical outcomes before and after intervention

    CharacteristicBefore intervention, % (no. of patients)*After intervention, % (no. of patients)*Between-group comparison, p value
    Experimental groupControl groupExperimental groupControl groupUnadjusted†Adjusted‡
    High-risk patients who received endoscopic therapy67.8 (152/177)83.3 (155/186)94.7 (143/151)86.1 (124/144)0.090.05
    Index endoscopy within 24 h62.8 (252/401)65.6 (278/424)57.5 (207/360)63.1 (245/388)0.30.1
    Time to index endoscopy, h, mean ± SD†38.0 ± 69.8
    n = 401
    28.1 ± 40.1
    n = 424
    33.5 ±51.6
    n = 361
    28.2 ± 37.2
    n = 388
    0.80.6
    Targeted irrigation of adherent clot performed68.8 (33/48)54.4 (25/46)73.8 (31/42)70.3 (26/37)0.8–
    Endoscopic treatment performed44.0 (177/402)40.1 (170/424)42.9 (155/361)38.8 (151/389)0.50.9
     Injection37.3 (150/402)31.4 (133/424)36.0 (130/361)29.3 (114/389)0.20.9
      Epinephrine/saline alone30.4 (122/402)30.4 (129/424)28.5 (103/361)27.0 (105/389)0.80.9
      Other7.0 (28/402)0.9 (4/424)7.5 (27/361)2.3 (9/389)0.2–
     Thermal18.4 (74/402)21.9 (93/424)19.4 (70/361)17.7 (69/389)0.70.4
     Clips16.9 (68/402)9.7 (41/424)14.4 (52/361)13.6 (53/389)0.80.3
     Other (ligation)0.0 (0/402)0.7 (3/424)1.1 (4/361)0.3 (1/389)0.1–
    Pre initial endoscopy, total daily dose of PPI, mg, mean ± SD
     Oral66.4 ± 46.4
    n = 45
    68.3 ± 69.4
    n = 48
    80.0 ± 46.4
    n = 37
    68.6 ± 49.5
    n = 49
    0.40.3
     Intravenous bolus80.0 ± 24.3
    n = 277
    81.4 ± 25.8
    n = 288
    81.4 ± 23.1
    n = 254
    81.5 ± 21.5
    n = 288
    0.950.9
     Intravenous constant infusion145.0 ± 150.1
    n = 273
    124.1 ± 129.3
    n = 289
    124.2 ± 126.6
    n = 254
    120.1 ± 113.8
    n = 288
    0.70.7
    Post initial endoscopy, total daily dose of PPI, mg, mean ± SD
     Oral91.7 ± 64.1
    n = 196
    98.8 ± 77.7
    n = 246
    116.8 ± 74.9
    n = 206
    116.1 ± 69.0
    n = 181
    0.950.3
     Intravenous bolus102.1 ± 53.6
    n = 76
    97.4 ± 68.6
    n = 62
    104.5 ± 80.8
    n = 62
    100.4 ± 57.3
    n = 51
    0.70.7
     Intravenous constant infusion380.4 ± 245.9
    n = 285
    380.5 ±233.3
    n = 306
    430.7 ± 258.8
    n = 252
    402.6 ± 264.5
    n = 288
    0.30.6
    Intensive care unit admission15.7 (63/402)14.9 (63/424)15.5 (56/361)13.1 (51/389)0.60.5
    Intensive care unit duration of stay, d, mean ± SD†6.0 ± 8.1
    n = 63
    4.4 ± 5.0
    n = 63
    4.7 ± 3.7
    n = 56
    6.5 ± 8.4
    n = 51
    0.40.4
    Re-bleeding, need for surgery or angiography to stop bleeding9.2 (37/402)9.0 (38/424)11.9 (43/361)8.2 (32/389)0.1–
    Re-bleeding8.0 (32/402)8.0 (34/424)11.1 (40/361)7.2 (28/389)0.1–
    Need for surgery to stop bleeding2.5 (10/402)1.7 (7/424)1.9 (7/361)2.1 (8/389)0.9–
    Need for angiographic procedure to stop bleeding2.5 (7/280)2.0 (6/300)2.8 (10/361)2.1 (8/389)0.5–
    Deaths6.0 (24/402)6.4 (27/424)6.4 (23/361)5.7 (22/389)0.7–
    Bleeding-related death1.5 (6/402)0.7 (3/424)2.2 (8/361)2.3 (9/389)0.9–
    Length of stay, d, mean ± SD§10.6 ± 15.4
    n = 362
    9.6 ± 15.7
    n = 381
    9.1 ± 10.1
    n = 331
    9.4 ± 12.1
    n = 351
    0.80.7
    Hospital stay less than 3 d¶20.0 (77/386)26.7 (109/408)20.1 (71/354)22.3 (83/373)0.70.9
    High-risk patients with hospital stay less than 3 d6.9 (12/174)14.6 (27/185)8.5 (13/153)11.8 (17/144)0.40.2
    • Note: PPI = proton pump inhibitors, SD = standard deviation.

    • ↵* Unless otherwise indicated.

    • ↵† χ2 for categorical variables or t-tests for continuous variables.

    • ↵‡ Adjusted for baseline, hospital size (≤ 400 v. > 400 beds), Ontario (yes v. no) and interaction of hospital size and Ontario location. Adjustment for site was made for p values using the generalized estimating equations for dichotomous outcomes and mixed models for continuous outcomes.

    • ↵§ Time to index endoscopy, ICU length of stay and hospital length of stay were log-transformed to improve normality.

    • ↵¶ Unless patient died during hospital stay.

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Canadian Medical Association Journal: 185 (3)
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Effectiveness of disseminating consensus management recommendations for ulcer bleeding: a cluster randomized trial
Alan N. Barkun, Mamatha Bhat, David Armstrong, Martin Dawes, Allan Donner, Robert Enns, Janet Martin, Paul Moayyedi, Joseph Romagnuolo, Larry Stitt
CMAJ Feb 2013, 185 (3) E156-E166; DOI: 10.1503/cmaj.120095

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Effectiveness of disseminating consensus management recommendations for ulcer bleeding: a cluster randomized trial
Alan N. Barkun, Mamatha Bhat, David Armstrong, Martin Dawes, Allan Donner, Robert Enns, Janet Martin, Paul Moayyedi, Joseph Romagnuolo, Larry Stitt
CMAJ Feb 2013, 185 (3) E156-E166; DOI: 10.1503/cmaj.120095
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