Loading...

Quality Assessment Results

Vural_2025.pdf

Status: Completed
Document Type: RCT
Assessment Tool: Cochrane RoB 2 (Risk of Bias tool for randomized trials) - Complete
Assessment completed!
17/17
Next check in: 5 seconds
100.0%
Overall Quality Score
17/17 criteria met

Assessment Details

Assessment Criterion AI Analysis AI Judgment Issues
Was the allocation sequence random?
rct_d1_1
The document states that the study was randomized and mentions 'block randomization' as the method used, but does not provide explicit details about how the allocation sequence was generated (e.g., computer-generated random numbers, random number tables). The description of randomization is present but lacks sufficient methodological detail to fully assess the adequacy of sequence generation.
some concerns
Was the allocation sequence concealed until participants were enrolled and assigned to interventions?
rct_d1_2
The document states that the study was randomized and describes the randomization method as 'block randomization', but it does not explicitly describe the method of allocation concealment. While the study is described as 'triple-blind', this does not necessarily confirm that allocation was concealed from those recruiting/enrolling participants. The absence of explicit details about allocation concealment methods (e.g., central allocation, sequentially numbered sealed envelopes) creates uncertainty about this aspect of bias prevention.
some concerns
Were there baseline imbalances that suggest a problem with randomization?
rct_d1_3
The document does not explicitly report baseline characteristics or their comparison between groups, which is necessary to assess potential imbalances that might suggest randomization failure. While the study describes randomization methods and statistical tests for outcomes, the absence of baseline data comparison leaves uncertainty about whether randomization successfully balanced known confounders.
some concerns
Were participants aware of their assigned intervention during the trial?
rct_d2_1
The document explicitly states that the trial was triple-blind, involving the patient, surgeon, and examiner, which directly addresses participant blinding. This clear statement meets the criterion requirement for assessing whether participants were aware of their assigned intervention.
low risk
Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?
rct_d2_2
The document explicitly states that the study was conducted as a 'triple-blind (involving the patient, surgeon, and examiner) controlled clinical trial' and that postoperative evaluations were performed by 'a surgeon blinded to the patient’s group allocation.' This provides clear evidence that care providers/personnel were blinded to treatment allocation.
low risk
Were there deviations from the intended intervention that arose because of the experimental context?
rct_d2_3
The study explicitly describes a triple-blind design involving patients, surgeons, and examiners, which minimizes deviations from intended interventions due to the experimental context. The use of standardized procedures and monitoring of compliance further reduces the risk of such deviations.
low risk
Was an appropriate analysis used to estimate the effect of assignment to intervention?
rct_d2_4
Raw response parsing failed. Original content: ```json { "judgment": "some concerns", "justification": "The document does not explicitly mention whether an intention-to-treat (ITT) analysis was performed. While the study describes randomizatio...
some concerns
Were data for this outcome available for all, or nearly all, participants randomized?
rct_d3_1
The document does not explicitly state whether outcome data were available for all or nearly all participants randomized. While the study describes the randomization of 60 patients into 4 groups of 15 each, there is no explicit mention of missing data rates or whether any participants were lost to follow-up. The absence of this information raises some concerns about the completeness of outcome data.
some concerns
Is there evidence that the result was not biased by missing outcome data?
rct_d3_2
The document provides some information about patient follow-up and outcome assessment but lacks explicit details about how missing outcome data were handled or whether there was any missing data at all. The study mentions standardized clinical scoring on postoperative days 1, 3, and 7, but there is no discussion of attrition rates, reasons for missing data, or methods used to address potential bias from missing data.
some concerns
Could missingness in the outcome depend on its true value?
rct_d3_3
Raw response parsing failed. Original content: ```json { "judgment": "some concerns", "justification": "The document does not explicitly address whether missing outcome data could depend on its true value. While the study describes follow-up p...
some concerns
Was the method of measuring the outcome inappropriate?
rct_d4_1
The document provides explicit details about the measurement method for the outcomes (edema and ecchymosis), including the use of a standardized scoring system and the blinding of the examiner. This demonstrates that the measurement method was both valid and reliable.
low risk
Could measurement or ascertainment of the outcome have differed between intervention groups?
rct_d4_2
The document provides explicit evidence that outcome assessment methods were standardized and performed by a blinded examiner, minimizing potential differences between intervention groups.
low risk
Were outcome assessors aware of the intervention received by study participants?
rct_d4_3
The document explicitly states that the study was conducted as a triple-blind controlled trial involving the patient, surgeon, and examiner. It further specifies that postoperative edema and ecchymosis were evaluated by a surgeon blinded to the patient’s group allocation. This provides clear evidence that outcome assessors were unaware of the intervention received by study participants.
low risk
Could assessment of the outcome have been influenced by knowledge of intervention received?
rct_d4_4
The study explicitly states that it was a triple-blind controlled trial involving the patient, surgeon, and examiner, and that postoperative assessments were performed by a surgeon blinded to group allocation. This directly addresses the criterion by ensuring outcome assessment was not influenced by knowledge of intervention received.
low risk
Were the data that produced this result analyzed in accordance with a pre-specified analysis plan?
rct_d5_1
Raw response parsing failed. Original content: ```json { "judgment": "some concerns", "justification": "The document does not explicitly mention a pre-specified analysis plan or protocol registration. While the methods section describes the st...
some concerns
Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible outcome measurements?
rct_d5_2
Raw response parsing failed. Original content: ```json { "judgment": "low risk", "justification": "The study explicitly pre-specified all outcome measurements (edema and ecchymosis) with standardized scoring systems and time points (postoperat...
low risk
Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible analyses of the data?
rct_d5_3
The study explicitly describes the pre-specified analysis plan and reports all planned outcomes without evidence of selective reporting. The methods section clearly states the statistical tests used for intergroup and intragroup comparisons, and the results section reports all primary outcomes as specified in the objectives.
low risk
Assessment Summary
17
Total Criteria
17
Criteria Met
0
Issues Found
100.0%
Quality Score

Document Preview