Barakat et al. 2828 Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative supervised exercise improves outcomes after elective abdominal aortic aneurysm repair. Ann Surg. 2016;264(1):47-53. http://dx.doi.org/10.1097/SLA.0000000000001609. PMid:26756766. http://dx.doi.org/10.1097/SLA.0000000000...
|
Quote: “Randomization was performed using opaque, sealed, identical envelopes containing the treatment allocation, according to a computer-generated sequence prepared by an independent professional. Patients were randomized into one of the 2 groups—the exercise (intervention) group or the standard treatment (control) group. The randomization process was witnessed by an independent research professional and was carried out during the initial visit after obtaining informed consent, but before preoperative assessments and interventions.”2828 Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative supervised exercise improves outcomes after elective abdominal aortic aneurysm repair. Ann Surg. 2016;264(1):47-53. http://dx.doi.org/10.1097/SLA.0000000000001609. PMid:26756766. http://dx.doi.org/10.1097/SLA.0000000000...
(p. 48). |
Random sequence generation (selection bias) |
“Low risk” |
Comment: randomization was described and seems to be appropriate. |
Allocation concealment (selection bias) “Unclear risk” |
Comment: not described |
Blinding of participants and personnel (performance bias) – all-cause mortality |
Quote: “Clinicians including consultant surgeons, anesthetists, department’s medical and nursing staff, and interventional radiologists were blinded to patient group allocation. This was ensured by explaining the importance of blinding to all study participants and performing all study procedures in the separate Academic department.”2828 Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative supervised exercise improves outcomes after elective abdominal aortic aneurysm repair. Ann Surg. 2016;264(1):47-53. http://dx.doi.org/10.1097/SLA.0000000000001609. PMid:26756766. http://dx.doi.org/10.1097/SLA.0000000000...
(p. 48). |
“High risk” |
Comment: due to the nature of the intervention, it is impossible to blind patients. |
Blinding of participants and personnel (performance bias) – number of patients with aortic rupture. |
Quote: “Clinicians including consultant surgeons, anesthetists, department’s medical and nursing staff, and interventional radiologists were blinded to patient group allocation. This was ensured by explaining the importance of blinding to all study participants and performing all study procedures in the separate Academic department.”2828 Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative supervised exercise improves outcomes after elective abdominal aortic aneurysm repair. Ann Surg. 2016;264(1):47-53. http://dx.doi.org/10.1097/SLA.0000000000001609. PMid:26756766. http://dx.doi.org/10.1097/SLA.0000000000...
(p. 48). |
“High risk” |
Comment: due to the nature of the intervention it is impossible to blind patients. |
Blinding of participants and personnel (performance bias) – aneurysm growth |
Quote: “Clinicians including consultant surgeons, anesthetists, department’s medical and nursing staff, and interventional radiologists were blinded to patient group allocation. This was ensured by explaining the importance of blinding to all study participants and performing all study procedures in the separate Academic department.”2828 Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative supervised exercise improves outcomes after elective abdominal aortic aneurysm repair. Ann Surg. 2016;264(1):47-53. http://dx.doi.org/10.1097/SLA.0000000000001609. PMid:26756766. http://dx.doi.org/10.1097/SLA.0000000000...
(p. 48). |
“High risk” |
Comment: due to the nature of the intervention it is impossible to blind patients. |
Blinding of participants and personnel (performance bias) – quality of life |
Not assessed |
Blinding of participants and personnel (performance bias) – number of patients referred for surgery |
Not assessed |
Blinding of participants and personnel (performance bias) – peri-operative complications |
Quote: “Clinicians including consultant surgeons, anesthetists, department’s medical and nursing staff, and interventional radiologists were blinded to patient group allocation. This was ensured by explaining the importance of blinding to all study participants and performing all study procedures in the separate Academic department.”2828 Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative supervised exercise improves outcomes after elective abdominal aortic aneurysm repair. Ann Surg. 2016;264(1):47-53. http://dx.doi.org/10.1097/SLA.0000000000001609. PMid:26756766. http://dx.doi.org/10.1097/SLA.0000000000...
(p. 48). |
“High risk” |
Comment: due to the nature of the intervention it is impossible to blind patients. |
Há Blinding of participants and personnel (performance bias) – postoperative complications |
Quote: “Clinicians including consultant surgeons, anesthetists, department’s medical and nursing staff, and interventional radiologists were blinded to patient group allocation. This was ensured by explaining the importance of blinding to all study participants and performing all study procedures in the separate Academic department.”2828 Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative supervised exercise improves outcomes after elective abdominal aortic aneurysm repair. Ann Surg. 2016;264(1):47-53. http://dx.doi.org/10.1097/SLA.0000000000001609. PMid:26756766. http://dx.doi.org/10.1097/SLA.0000000000...
(p. 48). |
“High risk” |
Comment: due to the nature of the intervention it is impossible to blind patients. |
Blinding of participants and personnel (performance bias) – cardiovascular mortality |
Quote: “Clinicians including consultant surgeons, anesthetists, department’s medical and nursing staff, and interventional radiologists were blinded to patient group allocation. This was ensured by explaining the importance of blinding to all study participants and performing all study procedures in the separate Academic department.”2828 Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative supervised exercise improves outcomes after elective abdominal aortic aneurysm repair. Ann Surg. 2016;264(1):47-53. http://dx.doi.org/10.1097/SLA.0000000000001609. PMid:26756766. http://dx.doi.org/10.1097/SLA.0000000000...
(p. 48). |
“High risk” |
Comment: due to the nature of the intervention it is impossible to blind patients. |
Blinding of participants and personnel (performance bias) – hospital stay |
Quote: “Clinicians including consultant surgeons, anesthetists, department’s medical and nursing staff, and interventional radiologists were blinded to patient group allocation. This was ensured by explaining the importance of blinding to all study participants and performing all study procedures in the separate Academic department.”2828 Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative supervised exercise improves outcomes after elective abdominal aortic aneurysm repair. Ann Surg. 2016;264(1):47-53. http://dx.doi.org/10.1097/SLA.0000000000001609. PMid:26756766. http://dx.doi.org/10.1097/SLA.0000000000...
(p. 48). |
“High risk” |
Comment: due to the nature of the intervention it is impossible to blind patients. |
Blinding of participants and personnel (performance bias) – VEF1 |
Not assessed |
Blinding of outcome assessment (detection bias) – all-cause mortality |
Quote: “Clinicians including consultant surgeons, anesthetists, department’s medical and nursing staff, and interventional radiologists were blinded to patient group allocation. This was ensured by explaining the importance of blinding to all study participants and performing all study procedures in the separate Academic department.”2828 Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative supervised exercise improves outcomes after elective abdominal aortic aneurysm repair. Ann Surg. 2016;264(1):47-53. http://dx.doi.org/10.1097/SLA.0000000000001609. PMid:26756766. http://dx.doi.org/10.1097/SLA.0000000000...
(p. 48). |
“Low risk” |
Comment: blinding of outcome assessment was described and seems to be appropriate |
Blinding of outcome assessment (detection bias) – number of patients with aortic rupture |
Quote: “Clinicians including consultant surgeons, anesthetists, department’s medical and nursing staff, and interventional radiologists were blinded to patient group allocation. This was ensured by explaining the importance of blinding to all study participants and performing all study procedures in the separate Academic department.”2828 Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative supervised exercise improves outcomes after elective abdominal aortic aneurysm repair. Ann Surg. 2016;264(1):47-53. http://dx.doi.org/10.1097/SLA.0000000000001609. PMid:26756766. http://dx.doi.org/10.1097/SLA.0000000000...
(p. 48). |
“Low risk” |
Comment: blinding of outcome assessment was described and seems to be appropriate |
Blinding of outcome assessment (detection bias) – aneurysm growth |
Quote: “Clinicians including consultant surgeons, anesthetists, department’s medical and nursing staff, and interventional radiologists were blinded to patient group allocation. This was ensured by explaining the importance of blinding to all study participants and performing all study procedures in the separate Academic department.”2828 Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative supervised exercise improves outcomes after elective abdominal aortic aneurysm repair. Ann Surg. 2016;264(1):47-53. http://dx.doi.org/10.1097/SLA.0000000000001609. PMid:26756766. http://dx.doi.org/10.1097/SLA.0000000000...
(p. 48). |
“Low risk” |
Comment: blinding of outcome assessment was described and seems to be appropriate |
Blinding of outcome assessment (detection bias) – quality of life |
Not assessed |
Blinding of outcome assessment (detection bias) – number of patients referred for surgery |
Not applicable |
Blinding of outcome assessment (detection bias) – peri-operative complications |
Quote: “Clinicians including consultant surgeons, anesthetists, department’s medical and nursing staff, and interventional radiologists were blinded to patient group allocation. This was ensured by explaining the importance of blinding to all study participants and performing all study procedures in the separate Academic department.”2828 Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative supervised exercise improves outcomes after elective abdominal aortic aneurysm repair. Ann Surg. 2016;264(1):47-53. http://dx.doi.org/10.1097/SLA.0000000000001609. PMid:26756766. http://dx.doi.org/10.1097/SLA.0000000000...
(p. 48). |
“Low risk” |
Comment: blinding of outcome assessment was described and seems to be appropriate |
Blinding of outcome assessment (detection bias) – postoperative complications |
Quote: “Clinicians including consultant surgeons, anesthetists, department’s medical and nursing staff, and interventional radiologists were blinded to patient group allocation. This was ensured by explaining the importance of blinding to all study participants and performing all study procedures in the separate Academic department.”2828 Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative supervised exercise improves outcomes after elective abdominal aortic aneurysm repair. Ann Surg. 2016;264(1):47-53. http://dx.doi.org/10.1097/SLA.0000000000001609. PMid:26756766. http://dx.doi.org/10.1097/SLA.0000000000...
(p. 48). |
“Low risk” |
Comment: blinding of outcome assessment was described and seems to be appropriate |
Blinding of outcome assessment (detection bias) – cardiovascular mortality |
Quote: “Clinicians including consultant surgeons, anesthetists, department’s medical and nursing staff, and interventional radiologists were blinded to patient group allocation. This was ensured by explaining the importance of blinding to all study participants and performing all study procedures in the separate Academic department.”2828 Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative supervised exercise improves outcomes after elective abdominal aortic aneurysm repair. Ann Surg. 2016;264(1):47-53. http://dx.doi.org/10.1097/SLA.0000000000001609. PMid:26756766. http://dx.doi.org/10.1097/SLA.0000000000...
(p. 48). |
“Low risk” |
Comment: blinding of outcome assessment was described and seems to be appropriate |
Blinding of outcome assessment (detection bias) – hospital stay |
Quote: “Clinicians including consultant surgeons, anesthetists, department’s medical and nursing staff, and interventional radiologists were blinded to patient group allocation. This was ensured by explaining the importance of blinding to all study participants and performing all study procedures in the separate Academic department.”2828 Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative supervised exercise improves outcomes after elective abdominal aortic aneurysm repair. Ann Surg. 2016;264(1):47-53. http://dx.doi.org/10.1097/SLA.0000000000001609. PMid:26756766. http://dx.doi.org/10.1097/SLA.0000000000...
(p. 48). |
“Low risk” |
Comment: blinding of outcome assessment was described and seems to be appropriate |
Blinding of outcome assessment (detection bias) – VEF1 |
Not assessed |
Incomplete outcome data (attrition bias) – all-cause mortality |
Quote: “Twelve patients—6 from each group—withdrew from the study before operative interventions as their procedures were cancelled or postponed. No patients were lost to follow-up. Sixty-two patients from each group were included in the final analysis.”2828 Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative supervised exercise improves outcomes after elective abdominal aortic aneurysm repair. Ann Surg. 2016;264(1):47-53. http://dx.doi.org/10.1097/SLA.0000000000001609. PMid:26756766. http://dx.doi.org/10.1097/SLA.0000000000...
|
“Low risk” |
Comment: there were 8.8% losses from each group and they were explained. There were no other loses of follow up. |
Incomplete outcome data (attrition bias) – number of patients with aortic rupture |
Quote: “Twelve patients—6 from each group—withdrew from the study before operative interventions as their procedures were cancelled or postponed. No patients were lost to follow-up. Sixty-two patients from each group were included in the final analysis.”2828 Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative supervised exercise improves outcomes after elective abdominal aortic aneurysm repair. Ann Surg. 2016;264(1):47-53. http://dx.doi.org/10.1097/SLA.0000000000001609. PMid:26756766. http://dx.doi.org/10.1097/SLA.0000000000...
|
“Low risk” |
Comment: there were 8.8% losses from each group and they were explained There were no other loses of follow up. |
Incomplete outcome data (attrition bias) – aneurysm growth |
Quote: “Twelve patients—6 from each group—withdrew from the study before operative interventions as their procedures were cancelled or postponed. No patients were lost to follow-up. Sixty-two patients from each group were included in the final analysis.” 2828 Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative supervised exercise improves outcomes after elective abdominal aortic aneurysm repair. Ann Surg. 2016;264(1):47-53. http://dx.doi.org/10.1097/SLA.0000000000001609. PMid:26756766. http://dx.doi.org/10.1097/SLA.0000000000...
|
“Low risk” |
Comment: there were 8.8% losses from each group and they were explained There were no other loses of follow up. |
Incomplete outcome data (attrition bias) – quality of life |
Not assessed |
Incomplete outcome data (attrition bias) – number of patients referred for surgery |
Not applicable |
Incomplete outcome data (attrition bias) – peri-operative complications |
Quote: “Twelve patients—6 from each group—withdrew from the study before operative interventions as their procedures were cancelled or postponed. No patients were lost to follow-up. Sixty-two patients from each group were included in the final analysis.” 2828 Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative supervised exercise improves outcomes after elective abdominal aortic aneurysm repair. Ann Surg. 2016;264(1):47-53. http://dx.doi.org/10.1097/SLA.0000000000001609. PMid:26756766. http://dx.doi.org/10.1097/SLA.0000000000...
|
“Low risk” |
Comment: there were 8.8% losses from each group and they were explained There were no other loses of follow up. |
Incomplete outcome data (attrition bias) – postoperative complications |
Quote: “Twelve patients—6 from each group—withdrew from the study before operative interventions as their procedures were cancelled or postponed. No patients were lost to follow-up. Sixty-two patients from each group were included in the final analysis.” 2828 Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative supervised exercise improves outcomes after elective abdominal aortic aneurysm repair. Ann Surg. 2016;264(1):47-53. http://dx.doi.org/10.1097/SLA.0000000000001609. PMid:26756766. http://dx.doi.org/10.1097/SLA.0000000000...
|
“Low risk” |
Comment: there were 8.8% losses from each group and they were explained There were no other loses of follow up. |
Incomplete outcome data (attrition bias) – cardiovascular mortality |
Quote: “Twelve patients—6 from each group—withdrew from the study before operative interventions as their procedures were cancelled or postponed. No patients were lost to follow-up. Sixty-two patients from each group were included in the final analysis.” 2828 Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative supervised exercise improves outcomes after elective abdominal aortic aneurysm repair. Ann Surg. 2016;264(1):47-53. http://dx.doi.org/10.1097/SLA.0000000000001609. PMid:26756766. http://dx.doi.org/10.1097/SLA.0000000000...
|
“Low risk” |
Comment: there were 8.8% losses from each group and they were explained There were no other loses of follow up. |
Incomplete outcome data (attrition bias) – hospital stay |
Quote: “Twelve patients—6 from each group—withdrew from the study before operative interventions as their procedures were cancelled or postponed. No patients were lost to follow-up. Sixty-two patients from each group were included in the final analysis.” 2828 Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative supervised exercise improves outcomes after elective abdominal aortic aneurysm repair. Ann Surg. 2016;264(1):47-53. http://dx.doi.org/10.1097/SLA.0000000000001609. PMid:26756766. http://dx.doi.org/10.1097/SLA.0000000000...
|
“Low risk” |
Comment: there were 8.8% losses from each group and they were explained There were no other loses of follow up. |
Incomplete outcome data (attrition bias) – VEF1 |
Not assessed |
Selective reporting (reporting bias) |
Comment: A protocol has been published: NCT01062594. All proposed outcomes were reported. |
“Low risk” |
Comment: there were no imbalances between groups. There were two different interventions (endovascular and open surgery). The numbers were balanced between groups. |
Other bias |
“Low risk” |
Kothmann et al.2929 Kothmann E, Danjoux G, Owen SJ, Parry A, Turley AJ, Batterham AM. Reliability of the anaerobic threshold in cardiopulmonary exercise testing of patients with abdominal aortic aneurysms. Anaesthesia. 2009;64(1):9-13. http://dx.doi.org/10.1111/j.1365-2044.2008.05690.x. PMid:19086999. http://dx.doi.org/10.1111/j.1365-2044.20...
|
Random sequence generation (selection bias) |
Quote: “...participants were randomly allocated (via sealed envelopes) to a supervised exercise intervention or to the control group (usual care).”2929 Kothmann E, Danjoux G, Owen SJ, Parry A, Turley AJ, Batterham AM. Reliability of the anaerobic threshold in cardiopulmonary exercise testing of patients with abdominal aortic aneurysms. Anaesthesia. 2009;64(1):9-13. http://dx.doi.org/10.1111/j.1365-2044.2008.05690.x. PMid:19086999. http://dx.doi.org/10.1111/j.1365-2044.20...
|
“Low risk” |
Comment: Randomization was described and seems to be appropriate. |
Allocation concealment (selection bias) |
Comment: not described |
“Unclear risk” |
Blinding of participants and personnel (performance bias) – all-cause mortality |
Comment: no information provided. Probably not done due to the nature of the intervention. |
“High risk” |
Blinding of participants and personnel (performance bias) – number of patients with aortic rupture. |
Comment: no information provided. Probably not done due to the nature of the intervention. |
“High risk” |
Blinding of participants and personnel (performance bias) – aneurysm growth |
Not assessed |
Blinding of participants and personnel (performance bias) – quality of life |
Not assessed |
Blinding of participants and personnel (performance bias) – number of patients referred for surgery |
Comment: no information provided. Probably not done due to the nature of the intervention. |
“High risk” |
Blinding of participants and personnel (performance bias) – peri-operative complications |
Not applicable |
Blinding of participants and personnel (performance bias) – postoperative complications |
Not applicable |
Blinding of participants and personnel (performance bias) – cardiovascular mortality |
Comment: no information provided. Probably not done due to the nature of the intervention. |
“High risk” |
Blinding of participants and personnel (performance bias) – hospital stay |
Not applicable |
Blinding of participants and personnel (performance bias) – VEF1 |
Not assessed |
Blinding of outcome assessment (detection bias) – all-cause mortality |
Quote: “In the paper we state: “The investigator reading AT results (G.D.) was blinded to group allocation.” Simply, GD was provided with the output from the cardiopulmonary exercise tests and derived the anaerobic threshold for each participant without knowledge of group assignment, i.e., blind.”2929 Kothmann E, Danjoux G, Owen SJ, Parry A, Turley AJ, Batterham AM. Reliability of the anaerobic threshold in cardiopulmonary exercise testing of patients with abdominal aortic aneurysms. Anaesthesia. 2009;64(1):9-13. http://dx.doi.org/10.1111/j.1365-2044.2008.05690.x. PMid:19086999. http://dx.doi.org/10.1111/j.1365-2044.20...
Provided by email |
“Low risk” |
Comment: blinding of outcome assessment properly described. |
Blinding of outcome assessment (detection bias) – number of patients with aortic rupture |
Quote: “In the paper we state: “The investigator reading AT results (G.D.) was blinded to group allocation.” Simply, GD was provided with the output from the cardiopulmonary exercise tests and derived the anaerobic threshold for each participant without knowledge of group assignment, i.e., blind.”2929 Kothmann E, Danjoux G, Owen SJ, Parry A, Turley AJ, Batterham AM. Reliability of the anaerobic threshold in cardiopulmonary exercise testing of patients with abdominal aortic aneurysms. Anaesthesia. 2009;64(1):9-13. http://dx.doi.org/10.1111/j.1365-2044.2008.05690.x. PMid:19086999. http://dx.doi.org/10.1111/j.1365-2044.20...
Provided by email |
“Low risk” |
Comment: blinding of outcome assessment properly described. |
Blinding of outcome assessment (detection bias) – aneurysm growth |
Not assessed |
Blinding of outcome assessment (detection bias) – quality of life |
Not assessed |
Blinding of outcome assessment (detection bias) – number of patients referred for surgery |
Quote: “In the paper we state: “The investigator reading AT results (G.D.) was blinded to group allocation.” Simply, GD was provided with the output from the cardiopulmonary exercise tests and derived the anaerobic threshold for each participant without knowledge of group assignment, i.e., blind.”2929 Kothmann E, Danjoux G, Owen SJ, Parry A, Turley AJ, Batterham AM. Reliability of the anaerobic threshold in cardiopulmonary exercise testing of patients with abdominal aortic aneurysms. Anaesthesia. 2009;64(1):9-13. http://dx.doi.org/10.1111/j.1365-2044.2008.05690.x. PMid:19086999. http://dx.doi.org/10.1111/j.1365-2044.20...
Provided by email |
“Low risk” |
Comment: blinding of outcome assessment properly described. |
Blinding of outcome assessment (detection bias) – peri-operative complications |
Not applicable |
Blinding of outcome assessment (detection bias) – postoperative complications |
Not applicable |
Blinding of outcome assessment (detection bias) – cardiovascular mortality |
Quote: “In the paper we state: “The investigator reading AT results (G.D.) was blinded to group allocation.” Simply, GD was provided with the output from the cardiopulmonary exercise tests and derived the anaerobic threshold for each participant without knowledge of group assignment, i.e., blind.”2929 Kothmann E, Danjoux G, Owen SJ, Parry A, Turley AJ, Batterham AM. Reliability of the anaerobic threshold in cardiopulmonary exercise testing of patients with abdominal aortic aneurysms. Anaesthesia. 2009;64(1):9-13. http://dx.doi.org/10.1111/j.1365-2044.2008.05690.x. PMid:19086999. http://dx.doi.org/10.1111/j.1365-2044.20...
Provided by email |
“Low risk” |
Comment: blinding of outcome assessment properly described. |
Blinding of outcome assessment (detection bias) – hospital stay |
Not applicable |
Blinding of outcome assessment (detection bias) – VEF1 |
Not assessed |
Incomplete outcome data (attrition bias) – all-cause mortality |
“Of these, 17 of 20 and eight of 10 completed the study period in the exercise and control groups, respectively, producing full data sets for analysis”2929 Kothmann E, Danjoux G, Owen SJ, Parry A, Turley AJ, Batterham AM. Reliability of the anaerobic threshold in cardiopulmonary exercise testing of patients with abdominal aortic aneurysms. Anaesthesia. 2009;64(1):9-13. http://dx.doi.org/10.1111/j.1365-2044.2008.05690.x. PMid:19086999. http://dx.doi.org/10.1111/j.1365-2044.20...
|
“Unclear risk” |
Comment: (There was 15% losses from the intervention group and 20% from the control group. We are not sure about the extent to which this could affect the results). |
Incomplete outcome data (attrition bias) – number of patients with aortic rupture |
“Of these, 17 of 20 and eight of 10 completed the study period in the exercise and control groups, respectively, producing full data sets for analysis”2929 Kothmann E, Danjoux G, Owen SJ, Parry A, Turley AJ, Batterham AM. Reliability of the anaerobic threshold in cardiopulmonary exercise testing of patients with abdominal aortic aneurysms. Anaesthesia. 2009;64(1):9-13. http://dx.doi.org/10.1111/j.1365-2044.2008.05690.x. PMid:19086999. http://dx.doi.org/10.1111/j.1365-2044.20...
|
“Unclear risk” |
Comment: (There was 15% losses from the intervention group and 20% from the control group. We are not sure about the extent to which this could affect the results). |
Incomplete outcome data (attrition bias) – aneurysm growth |
Not assessed |
Incomplete outcome data (attrition bias) – quality of life |
Not assessed |
Incomplete outcome data (attrition bias) – number of patients referred for surgery |
“Of these, 17 of 20 and eight of 10 completed the study period in the exercise and control groups, respectively, producing full data sets for analysis”2929 Kothmann E, Danjoux G, Owen SJ, Parry A, Turley AJ, Batterham AM. Reliability of the anaerobic threshold in cardiopulmonary exercise testing of patients with abdominal aortic aneurysms. Anaesthesia. 2009;64(1):9-13. http://dx.doi.org/10.1111/j.1365-2044.2008.05690.x. PMid:19086999. http://dx.doi.org/10.1111/j.1365-2044.20...
|
“unclear risk” |
Comment: There was 15% losses from the intervention group and 20% from the control group. We are not sure to what extent this could affect the results. |
Incomplete outcome data (attrition bias) – peri-operative complications |
Not applicable |
Incomplete outcome data (attrition bias) – postoperative complications |
Not applicable |
Incomplete outcome data (attrition bias) – cardiovascular mortality |
“Of these, 17 of 20 and eight of 10 completed the study period in the exercise and control groups, respectively, producing full data sets for analysis”2929 Kothmann E, Danjoux G, Owen SJ, Parry A, Turley AJ, Batterham AM. Reliability of the anaerobic threshold in cardiopulmonary exercise testing of patients with abdominal aortic aneurysms. Anaesthesia. 2009;64(1):9-13. http://dx.doi.org/10.1111/j.1365-2044.2008.05690.x. PMid:19086999. http://dx.doi.org/10.1111/j.1365-2044.20...
|
“Unclear risk” |
Comment: There was 15% losses from the intervention group and 20% from the control group. We are not sure to what extent this could affect the results. |
Incomplete outcome data (attrition bias) – hospital stay |
Not applicable |
Incomplete outcome data (attrition bias) – VEF1 |
Not assessed |
Selective reporting (reporting bias) |
Comment: All the proposed outcomes were reported. |
“Low risk” |
Other bias |
Comment: There is an uncertainty about the balance between groups at baseline, since no p value was provided. We are not sure to what extent this could affect the results. |
“Unclear risk” |
Myers et al.1111 Myers J, Mcelrath M, Jaffe A, et al. A randomized trial of exercise training in abdominal aortic aneurysm disease. Med Sci Sports Exerc. 2014;46(1):2-9. http://dx.doi.org/10.1249/MSS.0b013e3182a088b8. PMid:23793234. http://dx.doi.org/10.1249/MSS.0b013e3182...
|
Random sequence generation (selection bias) |
Quote: “One hundred and forty patients with small AAAs (72 T 8 yr) were randomised to exercise training (n = 72) or usual care (n = 68)”1111 Myers J, Mcelrath M, Jaffe A, et al. A randomized trial of exercise training in abdominal aortic aneurysm disease. Med Sci Sports Exerc. 2014;46(1):2-9. http://dx.doi.org/10.1249/MSS.0b013e3182a088b8. PMid:23793234. http://dx.doi.org/10.1249/MSS.0b013e3182...
|
“Unclear risk” |
Comment: Not described. |
Allocation concealment (selection bias) |
Comment: not described |
“Unclear risk” |
Blinding of participants and personnel (performance bias) – all-cause mortality |
Comment: not stated. Probably not done since the nature of intervention precluded this masking |
“High risk” |
Blinding of participants and personnel (performance bias) – number of patients with aortic rupture. |
Comment: not stated. Probably not done since the nature of intervention precluded this masking |
“High risk” |
Blinding of participants and personnel (performance bias) – aneurysm growth |
Comment: not stated. Probably not done since the nature of intervention precluded this masking |
“High risk” |
Blinding of participants and personnel (performance bias) – quality of life |
Not assessed |
Blinding of participants and personnel (performance bias) – number of patients referred for surgery |
Comment: not stated. Probably not done since the nature of intervention precluded this masking |
“High risk” |
Blinding of participants and personnel (performance bias) – peri-operative complications |
Not assessed |
Blinding of participants and personnel (performance bias) – postoperative complications |
Not assessed |
Blinding of participants and personnel (performance bias) – cardiovascular mortality |
Comment: not stated. Probably not done since the nature of intervention precluded this masking |
“High risk” |
Blinding of participants and personnel (performance bias) – hospital stay |
Not assessed |
Blinding of participants and personnel (performance bias) – VEF1 |
Not assessed |
Blinding of outcome assessment (detection bias) – all-cause mortality |
Quote: “Both the RVT and the individual making the diameter measurements were blinded to group randomisation”. Answered by e-mail: “both were unaware of the intervention or control group.”1111 Myers J, Mcelrath M, Jaffe A, et al. A randomized trial of exercise training in abdominal aortic aneurysm disease. Med Sci Sports Exerc. 2014;46(1):2-9. http://dx.doi.org/10.1249/MSS.0b013e3182a088b8. PMid:23793234. http://dx.doi.org/10.1249/MSS.0b013e3182...
|
“Unclear risk” |
Comment: no information provided for data assessors |
Blinding of outcome assessment (detection bias) – number of patients with aortic rupture |
Quote: Quote: “Both the RVT and the individual making the diameter measurements were blinded to group randomisation”. Answered by e-mail: “both were unaware of the intervention or control group.”1111 Myers J, Mcelrath M, Jaffe A, et al. A randomized trial of exercise training in abdominal aortic aneurysm disease. Med Sci Sports Exerc. 2014;46(1):2-9. http://dx.doi.org/10.1249/MSS.0b013e3182a088b8. PMid:23793234. http://dx.doi.org/10.1249/MSS.0b013e3182...
|
“Unclear risk” |
Comment: no information provided for data assessors |
Blinding of outcome assessment (detection bias) – aneurysm growth |
Quote: “Both the RVT and the individual making the diameter measurements were blinded to group randomisation”. Answered by e-mail: “both were unaware of the intervention or control group.”1111 Myers J, Mcelrath M, Jaffe A, et al. A randomized trial of exercise training in abdominal aortic aneurysm disease. Med Sci Sports Exerc. 2014;46(1):2-9. http://dx.doi.org/10.1249/MSS.0b013e3182a088b8. PMid:23793234. http://dx.doi.org/10.1249/MSS.0b013e3182...
|
“Unclear risk” |
Comment: no information provided for data assessors |
Blinding of outcome assessment (detection bias) – quality of life |
Not assessed |
Blinding of outcome assessment (detection bias) – number of patients referred for surgery |
Quote: “Both the RVT and the individual making the diameter measurements were blinded to group randomisation”. Answered by e-mail: “both were unaware of the intervention or control group.”1111 Myers J, Mcelrath M, Jaffe A, et al. A randomized trial of exercise training in abdominal aortic aneurysm disease. Med Sci Sports Exerc. 2014;46(1):2-9. http://dx.doi.org/10.1249/MSS.0b013e3182a088b8. PMid:23793234. http://dx.doi.org/10.1249/MSS.0b013e3182...
|
“Unclear risk” |
Comment: no information provided for data assessors |
Blinding of outcome assessment (detection bias) – peri-operative complications |
Not assessed |
Blinding of outcome assessment (detection bias) – postoperative complications |
Not assessed |
Blinding of outcome assessment (detection bias) – cardiovascular mortality |
Quote: “Both the RVT and the individual making the diameter measurements were blinded to group randomisation”. Answered by e-mail: “both were unaware of the intervention or control group.”1111 Myers J, Mcelrath M, Jaffe A, et al. A randomized trial of exercise training in abdominal aortic aneurysm disease. Med Sci Sports Exerc. 2014;46(1):2-9. http://dx.doi.org/10.1249/MSS.0b013e3182a088b8. PMid:23793234. http://dx.doi.org/10.1249/MSS.0b013e3182...
|
“Unclear risk” |
Comment: no information provided for data assessors |
Blinding of outcome assessment (detection bias) – hospital stay |
Not assessed |
Blinding of outcome assessment (detection bias) – VEF1 |
Not assessed |
Incomplete outcome data (attrition bias) – all-cause mortality |
Quote: “81% of subjects completed at least 1 year in the trial”1111 Myers J, Mcelrath M, Jaffe A, et al. A randomized trial of exercise training in abdominal aortic aneurysm disease. Med Sci Sports Exerc. 2014;46(1):2-9. http://dx.doi.org/10.1249/MSS.0b013e3182a088b8. PMid:23793234. http://dx.doi.org/10.1249/MSS.0b013e3182...
|
“High risk” |
Comment: There were 19% losses in one year. Additionally, at the end of follow-up, there were 39 losses from the intervention group and 36 from the control group. The reasons for these losses are unclear. |
Incomplete outcome data (attrition bias) – number of patients with aortic rupture |
Quote: “81% of subjects completed at least 1 year in the trial”1111 Myers J, Mcelrath M, Jaffe A, et al. A randomized trial of exercise training in abdominal aortic aneurysm disease. Med Sci Sports Exerc. 2014;46(1):2-9. http://dx.doi.org/10.1249/MSS.0b013e3182a088b8. PMid:23793234. http://dx.doi.org/10.1249/MSS.0b013e3182...
|
“High risk” |
Comment: There were 19% losses in one year. Additionally, at the end of follow-up, there were 39 losses from the intervention group and 36 from the control group. The reasons for these losses are unclear. |
Incomplete outcome data (attrition bias) – aneurysm growth |
Quote: “81% of subjects completed at least 1 year in the trial”1111 Myers J, Mcelrath M, Jaffe A, et al. A randomized trial of exercise training in abdominal aortic aneurysm disease. Med Sci Sports Exerc. 2014;46(1):2-9. http://dx.doi.org/10.1249/MSS.0b013e3182a088b8. PMid:23793234. http://dx.doi.org/10.1249/MSS.0b013e3182...
|
“High risk” |
Comment: There were 19% losses in one year. Additionally, at the end of follow-up, there were 39 losses from the intervention group and 36 from the control group. The reasons for these losses are unclear. |
Incomplete outcome data (attrition bias) – quality of life |
Not assessed |
Incomplete outcome data (attrition bias) – number of patients referred for surgery |
Quote: “81% of subjects completed at least 1 year in the trial”1111 Myers J, Mcelrath M, Jaffe A, et al. A randomized trial of exercise training in abdominal aortic aneurysm disease. Med Sci Sports Exerc. 2014;46(1):2-9. http://dx.doi.org/10.1249/MSS.0b013e3182a088b8. PMid:23793234. http://dx.doi.org/10.1249/MSS.0b013e3182...
|
“High risk” |
Comment: There were 19% losses in one year. Additionally, at the end of follow-up, there were 39 losses from the intervention group and 36 from the control group. The reasons for these losses are unclear. |
Incomplete outcome data (attrition bias) – peri-operative complications |
Not assessed |
Incomplete outcome data (attrition bias) – postoperative complications |
Not assessed |
Incomplete outcome data (attrition bias) – cardiovascular mortality |
Quote: “81% of subjects completed at least 1 year in the trial”1111 Myers J, Mcelrath M, Jaffe A, et al. A randomized trial of exercise training in abdominal aortic aneurysm disease. Med Sci Sports Exerc. 2014;46(1):2-9. http://dx.doi.org/10.1249/MSS.0b013e3182a088b8. PMid:23793234. http://dx.doi.org/10.1249/MSS.0b013e3182...
|
“High risk” |
Comment: There were 19% losses in one year. Additionally, at the end of follow-up, there were 39 losses from the intervention group and 36 from the control group. The reasons for these losses are unclear. |
Incomplete outcome data (attrition bias) – hospital stay |
Not assessed |
Incomplete outcome data (attrition bias) – VEF1 |
Not assessed |
Selective reporting (reporting bias) |
Quote: Protocol available at Clinicaltrials.gov, identifier: NCT00349947. |
“Low risk” |
Comment: protocol described. All proposed outcomes were reported |
Other bias |
Comment: There was an “imbalance between groups at baseline regarding BMI mean at baseline (p =0.002) and frequency of diabetes (30% vs. 12% in the exercise and usual care groups, respectively, P = 0.01).” 1111 Myers J, Mcelrath M, Jaffe A, et al. A randomized trial of exercise training in abdominal aortic aneurysm disease. Med Sci Sports Exerc. 2014;46(1):2-9. http://dx.doi.org/10.1249/MSS.0b013e3182a088b8. PMid:23793234. http://dx.doi.org/10.1249/MSS.0b013e3182...
|
“Unclear risk” |
We are not sure to what extent this could affect the results. |
Tew et al.1818 Tew GA, Moss J, Crank H, Mitchell PA, Nawaz S. Endurance exercise training in patients with small abdominal aortic aneurysm: a randomized controlled pilot study. Arch Phys Med Rehabil. 2012;93(12):2148-53. http://dx.doi.org/10.1016/j.apmr.2012.07.012. PMid:22846453. http://dx.doi.org/10.1016/j.apmr.2012.07...
|
Random sequence generation (selection bias) |
Quote: “Allocation to exercise or control was done using a randomization sequence created by an independent researcher before study commencement.”1818 Tew GA, Moss J, Crank H, Mitchell PA, Nawaz S. Endurance exercise training in patients with small abdominal aortic aneurysm: a randomized controlled pilot study. Arch Phys Med Rehabil. 2012;93(12):2148-53. http://dx.doi.org/10.1016/j.apmr.2012.07.012. PMid:22846453. http://dx.doi.org/10.1016/j.apmr.2012.07...
|
“Unclear risk” |
Comment: unclear information |
Allocation concealment (selection bias) |
Quote: “The study researchers were made aware of this sequence on a case-by-case basis after baseline assessments were completed.”1818 Tew GA, Moss J, Crank H, Mitchell PA, Nawaz S. Endurance exercise training in patients with small abdominal aortic aneurysm: a randomized controlled pilot study. Arch Phys Med Rehabil. 2012;93(12):2148-53. http://dx.doi.org/10.1016/j.apmr.2012.07.012. PMid:22846453. http://dx.doi.org/10.1016/j.apmr.2012.07...
|
“Unclear risk” |
Comment: unclear information |
Blinding of participants and personnel (performance bias) – all-cause mortality |
Quote: “Ventilatory threshold was determined by an independent exercise physiologist blinded to group allocation using the v-slope and ventilatory equivalents methods.”1818 Tew GA, Moss J, Crank H, Mitchell PA, Nawaz S. Endurance exercise training in patients with small abdominal aortic aneurysm: a randomized controlled pilot study. Arch Phys Med Rehabil. 2012;93(12):2148-53. http://dx.doi.org/10.1016/j.apmr.2012.07.012. PMid:22846453. http://dx.doi.org/10.1016/j.apmr.2012.07...
|
“High risk” |
Comment: The nature of the intervention precluded this masking |
Blinding of participants and personnel (performance bias) – number of patients with aortic rupture. |
Quote: “Ventilatory threshold was determined by an independent exercise physiologist blinded to group allocation using the v-slope and ventilatory equivalents methods.”1818 Tew GA, Moss J, Crank H, Mitchell PA, Nawaz S. Endurance exercise training in patients with small abdominal aortic aneurysm: a randomized controlled pilot study. Arch Phys Med Rehabil. 2012;93(12):2148-53. http://dx.doi.org/10.1016/j.apmr.2012.07.012. PMid:22846453. http://dx.doi.org/10.1016/j.apmr.2012.07...
|
“High risk” |
Comment: The nature of the intervention precluded this masking |
Blinding of participants and personnel (performance bias) – aneurysm growth |
Quote: “Ventilatory threshold was determined by an independent exercise physiologist blinded to group allocation using the v-slope and ventilatory equivalents methods.”1818 Tew GA, Moss J, Crank H, Mitchell PA, Nawaz S. Endurance exercise training in patients with small abdominal aortic aneurysm: a randomized controlled pilot study. Arch Phys Med Rehabil. 2012;93(12):2148-53. http://dx.doi.org/10.1016/j.apmr.2012.07.012. PMid:22846453. http://dx.doi.org/10.1016/j.apmr.2012.07...
|
“High risk” |
Comment: The nature of the intervention precluded this masking |
Blinding of participants and personnel (performance bias) – quality of life |
Quote: “Ventilatory threshold was determined by an independent exercise physiologist blinded to group allocation using the v-slope and ventilatory equivalents methods.”1818 Tew GA, Moss J, Crank H, Mitchell PA, Nawaz S. Endurance exercise training in patients with small abdominal aortic aneurysm: a randomized controlled pilot study. Arch Phys Med Rehabil. 2012;93(12):2148-53. http://dx.doi.org/10.1016/j.apmr.2012.07.012. PMid:22846453. http://dx.doi.org/10.1016/j.apmr.2012.07...
|
“High risk” |
Comment: The nature of the intervention precluded this masking |
Blinding of participants and personnel (performance bias) – number of patients referred for surgery |
Not assessed |
Blinding of participants and personnel (performance bias) – peri-operative complications |
Not applicable |
Blinding of participants and personnel (performance bias) – postoperative complications |
Not applicable |
Blinding of participants and personnel (performance bias) – cardiovascular mortality |
Quote: “Ventilatory threshold was determined by an independent exercise physiologist blinded to group allocation using the v-slope and ventilatory equivalents methods.”1818 Tew GA, Moss J, Crank H, Mitchell PA, Nawaz S. Endurance exercise training in patients with small abdominal aortic aneurysm: a randomized controlled pilot study. Arch Phys Med Rehabil. 2012;93(12):2148-53. http://dx.doi.org/10.1016/j.apmr.2012.07.012. PMid:22846453. http://dx.doi.org/10.1016/j.apmr.2012.07...
|
“High risk” |
Comment: The nature of the intervention precluded this masking |
Blinding of participants and personnel (performance bias) – hospital stay |
Not applicable |
Blinding of participants and personnel (performance bias) – VEF1 |
Not assessed |
Blinding of outcome assessment (detection bias) – all-cause mortality |
Quote: “The study researchers were made aware of this sequence on a case-by-case basis after baseline assessments were completed”.1818 Tew GA, Moss J, Crank H, Mitchell PA, Nawaz S. Endurance exercise training in patients with small abdominal aortic aneurysm: a randomized controlled pilot study. Arch Phys Med Rehabil. 2012;93(12):2148-53. http://dx.doi.org/10.1016/j.apmr.2012.07.012. PMid:22846453. http://dx.doi.org/10.1016/j.apmr.2012.07...
|
“High risk” |
Comment: There was no blinding |
Blinding of outcome assessment (detection bias) – number of patients with aortic rupture |
Quote: “The study researchers were made aware of this sequence on a case-by-case basis after baseline assessments were completed”.1818 Tew GA, Moss J, Crank H, Mitchell PA, Nawaz S. Endurance exercise training in patients with small abdominal aortic aneurysm: a randomized controlled pilot study. Arch Phys Med Rehabil. 2012;93(12):2148-53. http://dx.doi.org/10.1016/j.apmr.2012.07.012. PMid:22846453. http://dx.doi.org/10.1016/j.apmr.2012.07...
|
“High risk” |
Comment: There was no blinding |
Blinding of outcome assessment (detection bias) – aneurysm growth |
Quote: “The study researchers were made aware of this sequence on a case-by-case basis after baseline assessments were completed”.1818 Tew GA, Moss J, Crank H, Mitchell PA, Nawaz S. Endurance exercise training in patients with small abdominal aortic aneurysm: a randomized controlled pilot study. Arch Phys Med Rehabil. 2012;93(12):2148-53. http://dx.doi.org/10.1016/j.apmr.2012.07.012. PMid:22846453. http://dx.doi.org/10.1016/j.apmr.2012.07...
|
“High risk” |
Comment: There was no blinding |
Blinding of outcome assessment (detection bias) – quality of life |
Quote: The study researchers were made aware of this sequence on a case-by-case basis after baseline assessments were completed”.1818 Tew GA, Moss J, Crank H, Mitchell PA, Nawaz S. Endurance exercise training in patients with small abdominal aortic aneurysm: a randomized controlled pilot study. Arch Phys Med Rehabil. 2012;93(12):2148-53. http://dx.doi.org/10.1016/j.apmr.2012.07.012. PMid:22846453. http://dx.doi.org/10.1016/j.apmr.2012.07...
|
“High risk” |
Comment: There was no blinding |
Blinding of outcome assessment (detection bias) – number of patients referred for surgery |
Not assessed |
Blinding of outcome assessment (detection bias) – peri-operative complications |
Not applicable |
Blinding of outcome assessment (detection bias) – postoperative complications |
Not applicable |
Blinding of outcome assessment (detection bias) – cardiovascular mortality |
Quote: The study researchers were made aware of this sequence on a case-by-case basis after baseline assessments were completed”.1818 Tew GA, Moss J, Crank H, Mitchell PA, Nawaz S. Endurance exercise training in patients with small abdominal aortic aneurysm: a randomized controlled pilot study. Arch Phys Med Rehabil. 2012;93(12):2148-53. http://dx.doi.org/10.1016/j.apmr.2012.07.012. PMid:22846453. http://dx.doi.org/10.1016/j.apmr.2012.07...
|
“High risk” |
Comment: There was no blinding |
Blinding of outcome assessment (detection bias) – hospital stay |
Not applicable |
Blinding of outcome assessment (detection bias) – VEF1 |
Not assessed |
Incomplete outcome data (attrition bias) – all-cause mortality |
Quote: “Three participants did not complete the exercise intervention: 1 withdrew because of being diagnosed with cancer, 1 underwent pacemaker implantation, and 1 suffered a back injury at home”1818 Tew GA, Moss J, Crank H, Mitchell PA, Nawaz S. Endurance exercise training in patients with small abdominal aortic aneurysm: a randomized controlled pilot study. Arch Phys Med Rehabil. 2012;93(12):2148-53. http://dx.doi.org/10.1016/j.apmr.2012.07.012. PMid:22846453. http://dx.doi.org/10.1016/j.apmr.2012.07...
|
“Unclear risk” |
Comment: There were about 20% of losses from the intervention group, with reasons provided. We are not sure to what extent this could affect the results. |
Incomplete outcome data (attrition bias) – number of patients with aortic rupture |
Quote: “Three participants did not complete the exercise intervention: 1 withdrew because of being diagnosed with cancer, 1 underwent pacemaker implantation, and 1 suffered a back injury at home”1818 Tew GA, Moss J, Crank H, Mitchell PA, Nawaz S. Endurance exercise training in patients with small abdominal aortic aneurysm: a randomized controlled pilot study. Arch Phys Med Rehabil. 2012;93(12):2148-53. http://dx.doi.org/10.1016/j.apmr.2012.07.012. PMid:22846453. http://dx.doi.org/10.1016/j.apmr.2012.07...
|
“Unclear risk” |
Comment: There were about 20% of losses from the intervention group, with reasons provided. We are not sure to what extent this could affect the results. |
Incomplete outcome data (attrition bias) – aneurysm growth |
Quote: “Three participants did not complete the exercise intervention: 1 withdrew because of being diagnosed with cancer, 1 underwent pacemaker implantation, and 1 suffered a back injury at home”1818 Tew GA, Moss J, Crank H, Mitchell PA, Nawaz S. Endurance exercise training in patients with small abdominal aortic aneurysm: a randomized controlled pilot study. Arch Phys Med Rehabil. 2012;93(12):2148-53. http://dx.doi.org/10.1016/j.apmr.2012.07.012. PMid:22846453. http://dx.doi.org/10.1016/j.apmr.2012.07...
|
“Unclear risk” |
Comment: There were about 20% of losses from the intervention group, with reasons provided. We are not sure to what extent this could affect the results. |
Incomplete outcome data (attrition bias) – quality of life |
Quote: “Three participants did not complete the exercise intervention: 1 withdrew because of being diagnosed with cancer, 1 underwent pacemaker implantation, and 1 suffered a back injury at home”1818 Tew GA, Moss J, Crank H, Mitchell PA, Nawaz S. Endurance exercise training in patients with small abdominal aortic aneurysm: a randomized controlled pilot study. Arch Phys Med Rehabil. 2012;93(12):2148-53. http://dx.doi.org/10.1016/j.apmr.2012.07.012. PMid:22846453. http://dx.doi.org/10.1016/j.apmr.2012.07...
|
“Unclear risk” |
Comment: There were about 20% of losses from the intervention group, with reasons provided. We are not sure to what extent this could affect the results. |
Incomplete outcome data (attrition bias) – number of patients referred for surgery |
Not assessed |
Incomplete outcome data (attrition bias) – peri-operative complications |
Not applicable |
Incomplete outcome data (attrition bias) – postoperative complications |
Not applicable |
Incomplete outcome data (attrition bias) – cardiovascular mortality |
Quote: “Three participants did not complete the exercise intervention: 1 withdrew because of being diagnosed with cancer, 1 underwent pacemaker implantation, and 1 suffered a back injury at home”1818 Tew GA, Moss J, Crank H, Mitchell PA, Nawaz S. Endurance exercise training in patients with small abdominal aortic aneurysm: a randomized controlled pilot study. Arch Phys Med Rehabil. 2012;93(12):2148-53. http://dx.doi.org/10.1016/j.apmr.2012.07.012. PMid:22846453. http://dx.doi.org/10.1016/j.apmr.2012.07...
|
“Unclear risk” |
Comment: There were about 20% of losses from the intervention group, with reasons provided. We are not sure to what extent this could affect the results. |
Incomplete outcome data (attrition bias) – hospital stay |
Not applicable |
Incomplete outcome data (attrition bias) – VEF1 |
Not assessed |
Selective reporting (reporting bias) |
Quote: “The study was registered in ClinicalTrials.gov under reference no. NCT01234610.”1818 Tew GA, Moss J, Crank H, Mitchell PA, Nawaz S. Endurance exercise training in patients with small abdominal aortic aneurysm: a randomized controlled pilot study. Arch Phys Med Rehabil. 2012;93(12):2148-53. http://dx.doi.org/10.1016/j.apmr.2012.07.012. PMid:22846453. http://dx.doi.org/10.1016/j.apmr.2012.07...
|
“Low risk” |
Comment: there is a protocol and it seems to be appropriate. All proposed outcomes were reported. |
Does not show the data for the quality of life outcome: “...or any of the 8 quality of life domains (P.05; data not presented)”1818 Tew GA, Moss J, Crank H, Mitchell PA, Nawaz S. Endurance exercise training in patients with small abdominal aortic aneurysm: a randomized controlled pilot study. Arch Phys Med Rehabil. 2012;93(12):2148-53. http://dx.doi.org/10.1016/j.apmr.2012.07.012. PMid:22846453. http://dx.doi.org/10.1016/j.apmr.2012.07...
|
Other bias |
Comment: There is an uncertainty about the balance between groups at baseline, since no p value was provided. We are not sure to what extent this could affect the results. |
“Unclear risk |
Wnuk et al.3030 Wnuk BR, Durmała J, Ziaja K, Kotyla P, Woźniewski M, Błaszczak E. A controlled trial of the efficacy of a training walking program in patients recovering from abdominal aortic aneurysm surgery. Adv Clin Exp Med. 2016;25(6):1241-371. http://dx.doi.org/10.17219/acem/62239. PMid:28028979. http://dx.doi.org/10.17219/acem/62239...
|
Random sequence generation (selection bias) |
Quote: “The randomization of the study was conducted by drawing envelopes containing a number of the appropriate group – single blind study. Patients with the number 1 were qualified for the experimental group with backward walking training (group I), with number 2 for the experimental group with forward walking training (group II) and 3 for the control group.”3030 Wnuk BR, Durmała J, Ziaja K, Kotyla P, Woźniewski M, Błaszczak E. A controlled trial of the efficacy of a training walking program in patients recovering from abdominal aortic aneurysm surgery. Adv Clin Exp Med. 2016;25(6):1241-371. http://dx.doi.org/10.17219/acem/62239. PMid:28028979. http://dx.doi.org/10.17219/acem/62239...
|
“Low risk” |
Comment: randomization considered done and apparently appropriate. |
Allocation concealment (selection bias) |
Comment: not stated |
“Unclear risk” |
Blinding of participants and personnel (performance bias) – all-cause mortality |
Not assessed |
Blinding of participants and personnel (performance bias) – number of patients with aortic rupture. |
Not applicable |
Blinding of participants and personnel (performance bias) – aneurysm growth |
Not applicable |
Blinding of participants and personnel (performance bias) – quality of life |
Not assessed |
Blinding of participants and personnel (performance bias) – number of patients referred for surgery |
Not applicable |
Blinding of participants and personnel (performance bias) – peri-operative complications |
Not applicable |
Blinding of participants and personnel (performance bias) – postoperative complications |
Not assessed |
Blinding of participants and personnel (performance bias) – cardiovascular mortality |
Not assessed |
Blinding of participants and personnel (performance bias) – hospital stay |
Quote: “single blind study”3030 Wnuk BR, Durmała J, Ziaja K, Kotyla P, Woźniewski M, Błaszczak E. A controlled trial of the efficacy of a training walking program in patients recovering from abdominal aortic aneurysm surgery. Adv Clin Exp Med. 2016;25(6):1241-371. http://dx.doi.org/10.17219/acem/62239. PMid:28028979. http://dx.doi.org/10.17219/acem/62239...
|
“High risk” |
Comment: not blinded |
Blinding of participants and personnel |
Quote: “single blind study”3030 Wnuk BR, Durmała J, Ziaja K, Kotyla P, Woźniewski M, Błaszczak E. A controlled trial of the efficacy of a training walking program in patients recovering from abdominal aortic aneurysm surgery. Adv Clin Exp Med. 2016;25(6):1241-371. http://dx.doi.org/10.17219/acem/62239. PMid:28028979. http://dx.doi.org/10.17219/acem/62239...
|
(performance bias) – VEF1 |
Comment: not blinded |
“High risk” |
Blinding of outcome assessment (detection bias) – all-cause mortality |
Not assessed |
Blinding of outcome assessment (detection bias) – number of patients with aortic rupture |
Not applicable |
Blinding of outcome assessment (detection bias) – aneurysm growth |
Not applicable |
Blinding of outcome assessment (detection bias) – quality of life |
Not assessed |
Blinding of outcome assessment (detection bias) – number of patients referred for surgery |
Not applicable |
Blinding of outcome assessment (detection bias) – peri-operative complications |
Not applicable |
Blinding of outcome assessment (detection bias) – postoperative complications |
Not assessed |
Blinding of outcome assessment (detection bias) – cardiovascular mortality |
Not assessed |
Blinding of outcome assessment (detection bias) – hospital stay |
Quote: described as a single blinded study. Replied by e-mail 09/27/2017: “Measurement of gait parameters and spirometry was evaluated by physiotherapist from the Department of Rehabilitation. Routine physiotherapy and training walking in three groups was conducted by physiotherapist from the department of General and Vascular Surgery.”3030 Wnuk BR, Durmała J, Ziaja K, Kotyla P, Woźniewski M, Błaszczak E. A controlled trial of the efficacy of a training walking program in patients recovering from abdominal aortic aneurysm surgery. Adv Clin Exp Med. 2016;25(6):1241-371. http://dx.doi.org/10.17219/acem/62239. PMid:28028979. http://dx.doi.org/10.17219/acem/62239...
|
“Low risk” |
Comment: blinding of outcome assessment was described and seems to be appropriate. |
Blinding of outcome assessment (detection bias) – VEF1 |
Quote: described as a single blinded study. Replied by e-mail 09/27/2017: “Measurement of gait parameters and spirometry was evaluated by physiotherapist from the Department of Rehabilitation. Routine physiotherapy and training walking in three groups was conducted by physiotherapist from the department of General and Vascular Surgery.”3030 Wnuk BR, Durmała J, Ziaja K, Kotyla P, Woźniewski M, Błaszczak E. A controlled trial of the efficacy of a training walking program in patients recovering from abdominal aortic aneurysm surgery. Adv Clin Exp Med. 2016;25(6):1241-371. http://dx.doi.org/10.17219/acem/62239. PMid:28028979. http://dx.doi.org/10.17219/acem/62239...
|
“Low risk” |
Comment: blinding of outcome assessment was described and seems to be appropriate. |
Incomplete outcome data (attrition bias) – all-cause mortality |
Not assessed |
Incomplete outcome data (attrition bias) – number of patients with aortic rupture |
Not applicable |
Incomplete outcome data (attrition bias) – aneurysm growth |
Not applicable |
Incomplete outcome data (attrition bias) – quality of life |
Not assessed |
Incomplete outcome data (attrition bias) – number of patients referred for surgery |
Not applicable |
Incomplete outcome data (attrition bias) – peri-operative complications |
Not applicable |
Incomplete outcome data (attrition bias) – postoperative complications |
Not assessed |
Incomplete outcome data (attrition bias) – cardiovascular mortality |
Not assessed |
Incomplete outcome data (attrition bias) – hospital stay |
Comment: there were 27.41% dropouts and we do not what the impact of this would be on results and conclusions. |
“Unclear risk” |
Incomplete outcome data (attrition bias) – VEF1 |
Comment: there were 27.41% dropouts and we do not what the impact of this would be on results and conclusions. |
“Unclear risk” |
Selective reporting (reporting bias) |
Comment: the proposed outcomes were described and seem to be appropriate. |
“Low risk” |
Other bias |
Comment: describes balance between groups at baseline. No other source of bias detected. |
“Low risk” |