 |
| |
| Bias | Random
sequence generation (selection bias) |
Allocation
concealment (selection bias) |
Blinding
of participants and personnel (performance bias) All outcomes |
Blinding
of outcome assessment (detection bias) All outcomes |
Incomplete
outcome data (attrition bias) All outcomes |
Selective reporting (reporting bias) | Other bias |
Study |
|---|---|---|---|---|---|---|---|---|
| Authors’ judgment | Unclear risk | Low risk | Unclear risk | Unclear risk | Low risk | Low risk | Low risk | Dieli- Conwright 2018a |
| Support for judgment | Two-arm randomized controlled trial compared a progressive combined-aerobic and resistance-exercise intervention with usual care | Participants were randomly assigned (block size = 10 patients) to exercise or usual care after baseline testing using concealed randomization lists. | Information concerning the blinding of participants was not provided | Information concerning the blinding of the assessor was not provided | Four patients in the intervention group did not complete the study post- intervention: two lost to follow-up and two patients were unreachable. Five patients in the control group did not complete the study post-intervention: Three lost to follow up and two patients were unable to post-test as a result of a work conflict. Intention-to-treat analysis was applied | Expected outcomes were reported | Other biases have not been identified | |
| Authors’ judgment | Unclear risk | Low risk | Unclear risk | Unclear risk | Low risk | Low risk | Low risk | Dieli- Conwright 2018a |
| Support for judgment | Two-arm randomized controlled trial compared a progressive combined-aerobic and resistance-exercise intervention with usual care | Participants were randomly assigned (block size = 10 patients) to exercise or usual care after baseline testing using concealed randomization lists | Information concerning the blinding of participants was not provided | Information concerning the blinding of the assessor was not provided | Four patients in the intervention group did not complete the study post- intervention: two lost to follow-up and two patients were unreachable. Five patients in the control group did not complete the study post-intervention: Three lost to follow up and two patients were unable to post-test as a result of work conflict. Intention-to-treat analysis was applied. | Expected outcomes were reported | Other biases have not been identified | |
| Authors’ judgment | Unclear risk | Low risk | Low risk | Low risk | Low risk | Low risk | Low risk | Dieli- Conwright 2018a |
| Support for judgment | The participants were randomly assigned to either the exercise or control group, and scheduled for the baseline visit. Randomization was performed by the Clinical Investigation Support Office (CISO) at the USC NCCC | To prevent possible bias, study personnel involved in the recruitment did not have access to the randomization lists; the biostatistician who developed the randomization list did not have any patient contacts to influence the recruitment and allocation procedure | The participants were blinding | The assessor was blinding | One patient in the intervention dropped out due to the group lost to follow-up. Intention-to-treat analysis was applied | Expected outcomes were reported | Other biases have not been identified | |
| Authors’ judgment | Unclear risk | Low risk | Unclear risk | Unclear risk | Low risk | Low risk | Low risk | Dieli- Conwright 2018a |
| Support for judgment | This two-arm randomized controlled trial compared a progressive combined—aerobic and resistance—exercise intervention with usual care | Participants were randomly assigned (block size = 10 patients) to exercise or usual care after baseline testing using concealed randomization lists | Information concerning the blinding of participants were not provided | Information concerning the blinding of the assessor was not provided | four patients of the intervention group did not complete the study post-intervention: two lost to follow-up and two patients were unreachable. Five patients in the control group did not complete the study post- intervention: Three lost to follow up and two patients were unable to post-test as a result of work conflict. Intention-to- treat analysis was applied | Expected outcomes were reported | Other biases have not been identified | |
| Authors’ judgment | Unclear risk | Low risk | Unclear risk | Unclear risk | Low risk | Low risk | Low risk | Dieli- Conwright 2019 |
| Support for judgment | This two-arm randomized controlled trial compared a progressive combined—aerobic and resistance—exercise intervention with usual care. | Participants were randomly assigned (block size = 10 patients) to exercise or usual care after baseline testing using concealed randomization lists | Information concerning the blinding of participants were not provided | Information concerning blinding of participants were not provided | All the participants completed the study | Expected outcomes were reported | Other biases have not been identified | |
| Authors’ judgment | Unclear risk | Low risk | Unclear risk | Unclear risk | Low risk | Low risk | Low risk | Dieli- Conwright 2019 |
| Support for judgment | Randomized control trial comparing a weight loss intervention to usual care. | Participants were randomly assigned (block size = 10 patients) to exercise or usual care after baseline testing using concealed randomization lists | Information concerning the blinding of participants were not provided | Information concerning the blinding of the assessor was not provided | All the participants completed the study | Expected outcomes were reported | Other biases have not been identified | |
| Authors’ judgment | Unclear risk | Low risk | High risk | Unclear risk | Low risk | Low risk | Low risk | Dieli- Conwright 2022 |
| Support for judgment | A randomized trial comparing a weight loss intervention to usual care. | Twenty-five participants were randomly assigned to intervention and control groups after baseline testing using concealed randomization lists | Participants were not blinded to intervention assignment | Information concerning the blinding of the assessor was not provided | All the participants completed the study | Expected outcomes were reported | Other biases have not been identified | |
| Authors’ judgment | Unclear risk | Low risk | Low risk | Low risk | Low risk | Low risk | Low risk | Brown
|
| Support for judgment | Participants were randomly assigned in an equal ratio to intervention and control groups | After baseline testing, participants were allocated into two groups and were randomized using a computerized covariate adaptive procedure | Participants were blinding | The assessor was blinding | All the participants completed the study | Expected outcomes were reported | Other biases have not been identified | |
| Authors’ judgment | Unclear risk | Low risk | High risk | Low risk | Low risk | Low risk | Low risk | Ergun
|
| Support for judgment | Participants were randomly assigned in an equal ratio to intervention and control groups. | After baseline testing, participants were allocated into two groups and were randomized using a computerized covariate adaptive procedure | Participants were not blinded to intervention assignment | The assessor was blinding | All the participants completed the study | Expected outcomes were reported | Other biases have not been identified | |
| Authors’ judgment | Low risk | Low risk | Low risk | Low risk | Low risk | Low risk | Low risk | Rogers
|
| Support for judgment | A randomized controlled trial compared an intervention with a control group. Randomization was based on computer-generated numbers, performed in blocks of 4, and revealed in the order in which participants completed baseline testing | Allocation was concealed by central randomization and only revealed after baseline assessment | Participants were blinded | The assessor was blinding | One patient in the intervention group lost to follow-up due to lack of time. One patient in the control group dropped out when asked to repeat a blood draw. Intention-to-treat analysis was applied. | Expected outcomes were reported | Other biases have not been identified | |
| Authors’ judgment | Low risk | Low risk | Low risk | Low risk | Low risk | Low risk | Low risk | Rogers
|
| Support for judgment | This two-arm randomized controlled trial compared an intervention with a control group using, randomization was done in blocks of four based on computer generated numbers. | Randomization numbers were kept in sealed, opaque envelopes so that study staff and participants were unaware of group allocation until all baseline testing was complete. | Participants were blinded | ALL measures were obtained by individuals who were blinded to the participant's study group allocation | Two participants developed cancer recurrence during the trial (both in the intervention group). These two participants were dropped from the analysis for scientific reasons. Two patients in the control group dropped out due to the lack of time. Intention-to-treat analysis was applied. | Expected outcomes were reported | Other biases have not been identified | |
| Authors’ judgment | Low risk | Low risk | Low risk | Low risk | Low risk | Low risk | Low risk | Rogers
|
| Support for judgment | This two-arm randomized controlled trial compared an intervention with a control group, using randomization that was conducted in blocks of four based on computer generated numbers | Randomization numbers were kept in sealed, opaque envelopes so that study staff and participants were unaware of group allocation until all baseline testing was complete. | Participants were blinded | ALL measures were obtained by individuals who were blinded to the participant's study group allocation | Two participants developed cancer recurrence during the trial (both in the intervention group). These two participants were dropped from the analysis for scientific reasons. Two patients in the control group dropped out due to the lack of time. Intention-to-treat analysis was applied. | Expected outcomes were reported | Other biases have not been identified | |
| Authors’ judgment | Unclear risk | Unclear risk | High risk | Unclear risk | Unclear risk | Low risk | Low risk | Hutnick
|
| Support for judgment | patients with breast cancer were assigned to intervention and control groups. | 36 patients with breast cancer were enrolled in a 6-month moderate exercise program very soon after completing chemotherapy or radiation treatment to the intervention and control group. | Participants were not blinding | Information concerning the blinding of the assessor was not provided. | Seven patients in the intervention group dropped out. Six patients in the control group dropped out after the midpoint of the study. However, the reasons for this were not explained. Intention-to-treat analysis was applied. | Expected outcomes were reported | Other biases have not been identified | |
| Authors’ judgment | Unclear risk | Low risk | Low risk | High risk | Low risk | Low risk | Low risk | Battaglini
|
| Support for judgment | The participants were randomly assigned to exercise or control group | The patients had to choose a number between 1 and 20 for the allocation process. Even-numbered participants were assigned to the experimental group, whereas odd-numbered participants were assigned to the control group | Participants were blinding | The assessor was not blinding. | All the participants completed the study. | Expected outcomes were reported | Other biases have not been identified | |
| Authors’ judgment | Low risk | Low risk | High risk | Low risk | Low risk | Low risk | Low risk | Mutrie
|
| Support for judgment | The study was a two-group (intervention and control) by three time points (baseline, 12 weeks, and six-month follow-up) randomized controlled trial. The randomization was stratified by hospital and treatment at baseline and used randomized permuted blocks of length four and six (that is, for sequences of four or six women in each hospital-treatment combination, exactly half were allocated to each group). | After written informed consent and baseline measures, participants were randomly allocated women into one of two groups using randomization list. | Blinding of the participants was not possible | The assessors were blinding | 14 patients in the intervention group did not complete the study: Seven patients were lost to follow-up, four patients did not return the questionnaire, one patient was too ill, and two patients were not contactable. Eight patients in the control group did not complete the study: Four patients were lost to follow-up, two patients did not return the questionnaire, one died, and one withdrew. Intention-to-treat analysis was applied. | Expected outcomes were reported | Other biases have not been identified | |
| Authors’ judgment | Unclear risk | Low risk | Low risk | Low risk | Low risk | Low risk | Low risk | Nieman
|
| Support for judgment | Sixteen female breast cancer patients between the ages of 35 and 72 years were recruited for the study | After written informed consent and baseline measures, Subjects were randomly assigned to either an exercise or control group. | The participants were blinding | Information concerning the blinding of the assessor was not provided | Two patients (one from each group did not complete the study, because of the recurrence of the disease. Intention-to-treat analysis was applied | Expected outcomes were reported | Other biases have not been identified | |
| Authors’ judgment | Unclear risk | Low risk | Low risk | High risk | Low risk | Low risk | Low risk | Ligibel
|
| Support for judgment | 101 sedentary, overweight breast cancer survivors were randomly assigned either to exercise intervention or to a usual care control group | After enrolment, participants were randomly assigned 1:1 to an exercise intervention group or control group | The participants were blinding | Participants underwent a series of anthropometric measurements at the time of study enrolment (baseline), and these were repeated after the 16-week study period by study staff who were not blinded to group assignment | 11 patients in the intervention group did not complete the study for the following reasons: Two lost to follow-up, one had a family emergency, three had too much of a time commitment, one was too ill for final, one had a disease recurrence, one developed unrelated cancer, one withdrew consent, and one need for unrelated surgery. Seven patients in the control group did not complete the study for the following reasons: Three lost to follow-up, two had disease recurrence, one withdrew upon assignment to the control group, and one for family problems. However, intention-to-treat analysis was applied | Expected outcomes were reported | Other biases have not been identified | |
| Authors’ judgment | Unclear risk | Low risk | Low risk | High risk | Low risk | Low risk | Low risk | Ligibel
|
| Support for judgment | 101 sedentary, overweight breast cancer survivors were randomly assigned either to exercise intervention or to a usual care control group | After enrolment, participants were randomly assigned 1:1 to an exercise intervention group or control group | The participants were blinding | Participants underwent a series of anthropometric measurements at the time of study enrolment (baseline), and these were repeated after the 16-week study period by study staff who were not blinded to group assignment | 11 patients in the intervention group did not complete the study for the following reasons: Two lost to follow-up, one had a family emergency, three had too much of a time commitment, one was too ill for final, one disease recurrence, one developed unrelated cancer, one withdrew consent, and one need for unrelated surgery. Seven patients in the control group did not complete the study for the following reasons: Three lost to follow-up, two disease recurrence, one withdrew upon assignment to the control group, and one for family problems. However, intention-to-treat analysis was applied | Expected outcomes were reported | Other biases have not been identified | |
| Authors’ judgment | Low risk | Low risk | Low risk | Low risk | Low risk | Low risk | Low risk | Ligibel 2019 |
| Support for judgment | Participants were randomized 1:1 to an exercise and control group. All participants were randomized through the Quality Assurance for Clinical Trials (QACT) Core at Dana-Farber, which served as the coordinating center of the study. | After baseline measures 48 participants were randomly assigned to an exercise intervention group or control group | The participants were blinding | The assessor was blinding | One patient in the intervention group was found to be ineligible after randomization and two patients in the control group withdrew consent after randomization. Intention-to-treat analysis was applied | Expected outcomes were reported | Other biases have not been identified | |
| Authors’ judgment | Unclear risk | Low risk | Low risk | Low risk | Low risk | Low risk | Low risk | Jones
|
| Support for judgment | A quasi-randomized design where each group comprised exercising or non-exercising breast cancer survivors of similar age and treatment characteristics | A simple randomization procedure using the number on entry to allocate women as they entered the trial, on a 1:1 basis, was undertaken. Breast cancer survivors with odd numbers began the 12-week exercise treatment protocol immediately, while even-numbered women acted as wait-listed, non- exercising controls. The control women could access the intervention protocol after their testing in week 13. None of the authors were involved in the recruitment of the participants. | The participants were blinding | The assessor was blinding | Three control participants did not complete data collection, one incurred an ankle injury (not intervention-related), one moved to another town, and one chose to withdraw before any baseline measures. Intention-to-treat analysis was applied | Expected outcomes were reported | Other biases have not been identified | |
| Authors’ judgment | Unclear risk | Low risk | Unclear risk | Unclear risk | Low risk | Low risk | Low risk | Lee
|
| Support for judgment | This randomized clinical trial compared an aerobic and resistance exercise intervention with usual care. | For each patient recruited into the study, written informed consent is obtained before performing randomization or outcome measure testing. Upon written informed consent, the patient is randomly allocated to either the Exercise or Control groups. To prevent possible bias, study personnel involved in the recruitment and allocation did not have access to the randomization lists | Information concerning the blinding of the participants was not provided. | Information concerning the blinding of the assessor was not provided | Three patients in the intervention group did not complete the study for the following reasons: Two had Work conflicts, and one had disease progression. Three participants in the control group lost to follow-up post-intervention for the reasons: one family emergency, and two unreachable. Intention-to-treat analysis was applied | Expected outcomes were reported | Other biases have not been identified | |
| Authors’ judgment | Low risk | Low risk | Low risk | Low risk | Low risk | Low risk | Low risk | Saxton
|
| Support for judgment | A total of 85 women treated for breast cancer 3 to 18 months were randomly allocated to a 6-month to exercise and control group. Randomization was performed by an independent researcher at the Clinical Trials Research Unit, University of Leeds | A total of 85 women treated for breast cancer 3 to 18 months were randomly allocated to a 6-month to exercise and control group. Randomization was performed by an independent researcher at the Clinical Trials Research Unit, University of Leeds. The randomization sequence and allocation were not disclosed until patients had completed their baseline assessments | The participants were blinding |