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Quality assessment of randomized controlled trials (prospective clinical trial) | Quality assessment of case series |
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Randomization | N/A |
(1) Were adequate methods used for randomization? (N/A) | ā |
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Patient and site characteristics | Patient and site characteristics |
(1) Were patient characteristics well described for both groups? | (1) Were patient characteristics well described? |
(2) Were site characteristics well described for both groups? | (2) Were site characteristics well described? |
(3) Were there no disparities in terms of patient or site characteristics between the groups? | ā |
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Patient selection | Patient selection |
(1) Were the inclusion and exclusion criteria well described and the same for both groups? | (1) Were the inclusion and exclusion criteria well described? |
(2) Did the study report consecutively treated patients? | (2) Did the study report on consecutively treated patients? |
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Intervention | Intervention |
(1) Were interventions for both groups clearly described? | (1) Was the intervention clearly described? |
(2) Were all patients of the same group treated according to the same intervention? | (2) Were all patients treated according to the same intervention? |
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Evaluation method | Evaluation method |
(1) Was blinding used to assess the outcome? | (1) Was the outcome assessed by an investigator who had not been involved in the treatment? |
(2) Were adequate methods used to assess the outcome? | (2) Were adequate methods used to assess the outcome? |
(3) Were reproducibility data reported on the outcome variable(s)? | (3) Were reproducibility data reported on the outcome variable(s)? |
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Outcome & follow-up | Outcome & follow-up |
(1) Was the outcome clearly described? | (1) Was the outcome clearly described? |
(2) Was an intention-to-treat analysis performed and was there low risk for selective loss to follow-up? | (2) Was the response rate acceptable and was the number of patients lost to follow-up clearly described? |
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