Vural_2025.pdf
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 |