Vural_2023.pdf
| Assessment Criterion | AI Analysis | AI Judgment | Issues |
|---|---|---|---|
|
Was the allocation sequence random?
rct_d1_1
|
The document explicitly states that the allocation sequence was generated using a block randomization technique, which is an adequate method for random sequence generation. This meets the Cochrane RoB 2.0 criterion for random sequence generation.
|
low risk | |
|
Was the allocation sequence concealed until participants were enrolled and assigned to interventions?
rct_d1_2
|
Raw response parsing failed. Original content: ```json
{
"judgment": "some concerns",
"justification": "The document mentions the use of 'block randomization technique' but does not explicitly describe the method of allocation concealment. Whi...
|
some concerns | |
|
Were there baseline imbalances that suggest a problem with randomization?
rct_d1_3
|
Raw response parsing failed. Original content: ```json
{
"judgment": "low risk",
"justification": "The document provides explicit evidence of baseline characteristics being balanced between groups, with no significant differences in age or sex...
|
low risk | |
|
Were participants aware of their assigned intervention during the trial?
rct_d2_1
|
The document explicitly states that the study was designed as a triple-blinded (patient, surgeon, and examiner) controlled clinical trial, which includes blinding of participants to their assigned intervention. This is further supported by the description of the intervention where pledgets were prepared by the operating nurse and given to the surgeon, who was blinded to the group allocation, ensuring participants were unaware of their treatment.
|
low risk | |
|
Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?
rct_d2_2
|
Raw response parsing failed. Original content: ```json
{
"judgment": "some concerns",
"justification": "The document states that the study was 'triple-blinded (patient, surgeon, and examiner)' (P2.L53), which suggests that care providers were ...
|
some concerns | |
|
Were there deviations from the intended intervention that arose because of the experimental context?
rct_d2_3
|
The study explicitly describes the interventions and controls in detail, with no indication of deviations from the intended interventions due to the experimental context. Both groups received identical procedural treatments except for the application of tranexamic acid versus saline, which was the intended experimental manipulation. The study was triple-blinded (patient, surgeon, and examiner), reducing the likelihood of deviations influenced by the experimental context.
|
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 state whether an intention-to-treat (ITT) analysis was performed. While the study describes randomization ...
|
some concerns | |
|
Were data for this outcome available for all, or nearly all, participants randomized?
rct_d3_1
|
Raw response parsing failed. Original content: ```json
{
"judgment": "some concerns",
"justification": "The document provides explicit information about the number of participants randomized (50 patients divided into two groups of 25 each) and...
|
some concerns | |
|
Is there evidence that the result was not biased by missing outcome data?
rct_d3_2
|
Raw response parsing failed. Original content: ```json
{
"judgment": "some concerns",
"justification": "The document provides some information about outcome data collection and analysis but lacks explicit details on how missing outcome data we...
|
some concerns | |
|
Could missingness in the outcome depend on its true value?
rct_d3_3
|
The document does not explicitly state whether missing outcome data could depend on its true value. While the study describes the collection of outcome data (photographs taken on postoperative days 1, 3, and 7) and the scoring process, there is no mention of how missing data was handled or whether any data was missing. The absence of this information prevents a definitive judgment on whether missingness could be related to the outcome's true value.
|
some concerns | |
|
Was the method of measuring the outcome inappropriate?
rct_d4_1
|
Raw response parsing failed. Original content: ```json
{
"judgment": "low risk",
"justification": "The method of measuring the outcome is explicitly described and appears appropriate. The study used digital photographs taken under standardized...
|
low risk | |
|
Could measurement or ascertainment of the outcome have differed between intervention groups?
rct_d4_2
|
The study explicitly describes a standardized outcome assessment procedure that was identical for both intervention groups, conducted by blinded assessors using a validated scale. The methods section clearly states that digital photographs were taken under the same conditions for all patients and analyzed by two blinded researchers using a standardized scale, with scores averaged for comparison. This rigorous approach minimizes the risk of differential outcome measurement between 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 designed as a triple-blinded (patient, surgeon, and examiner) controlled clinical trial, and specifically mentions that outcome assessors were blinded to the surgical procedures. This directly addresses the criterion regarding blinding of outcome assessors.
|
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 triple-blinded (patient, surgeon, and examiner) and describes the blinding procedures for outcome assessment. Digital photographs were analyzed by two researchers who were blinded to the surgical procedures, using a standardized scale. The interrater reliability was reported, indicating consistency in outcome assessment.
|
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 for data analysis. While the statistical methods are des...
|
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": "some concerns",
"justification": "The study reports outcomes for eyelid edema and periorbital ecchymosis at three time points (postoperative days 1, 3, and 7), which are exp...
|
some concerns | |
|
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
|
Raw response parsing failed. Original content: ```json
{
"judgment": "low risk",
"justification": "The study explicitly states the pre-specified outcomes (eyelid edema and periorbital ecchymosis) and reports results for these outcomes at all m...
|
low risk |