Berinstein_1998.pdf
| Assessment Criterion | AI Analysis | AI Judgment | Issues |
|---|---|---|---|
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Was the allocation sequence random?
rct_d1_1
|
The document states that the study was randomized but does not provide explicit details about how the allocation sequence was generated (e.g., computer-generated random numbers, random number tables). The term 'randomly assigned' is used, but without methodological specifics, we cannot confirm adequate 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 but provides no explicit description of allocation sequence concealment methods. While randomization is mentioned, the critical detail of how allocation was concealed from those recruiting/enrolling participants is absent.
|
some concerns | |
|
Were there baseline imbalances that suggest a problem with randomization?
rct_d1_3
|
The document provides limited information about baseline characteristics of the study groups. While it states that all participants were men aged 18-45 years and underwent rhinoplasty with osteotomy, there is no explicit reporting of baseline characteristics by treatment group to assess potential imbalances that might suggest randomization failure. The only potential imbalance mentioned is regarding multiple operators, but this is not clearly linked to randomization issues.
|
some concerns | |
|
Were participants aware of their assigned intervention during the trial?
rct_d2_1
|
The document explicitly states that the study was 'double-blind' in multiple locations, which directly addresses participant awareness of their assigned intervention. The term 'double-blind' inherently means both participants and investigators were unaware of treatment assignments. This is further supported by the description of neuroradiologists being 'blinded to the patients' group assignments', indicating a maintained blinding protocol.
|
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 'double-blind' and provides specific details about who was blinded. The neuroradiologists assessing the outcomes were blinded to group assignments, which directly addresses the criterion about intervention awareness during the trial.
|
low risk | |
|
Were there deviations from the intended intervention that arose because of the experimental context?
rct_d2_3
|
The study explicitly describes a standardized protocol for administering the intervention (dexamethasone) and maintaining blinding, with no evidence of deviations from intended interventions due to the experimental context. The control group received no dexamethasone, and both groups underwent identical surgical procedures and postoperative assessments.
|
low risk | |
|
Was an appropriate analysis used to estimate the effect of assignment to intervention?
rct_d2_4
|
The document does not explicitly mention whether an intention-to-treat (ITT) analysis was used. While the study describes a randomized, double-blind design and reports results for all enrolled patients, there is no direct statement confirming ITT analysis was performed. The analysis method mentioned is a factorial analysis of variance, but this does not inherently confirm ITT principles were followed.
|
some concerns | |
|
Were data for this outcome available for all, or nearly all, participants randomized?
rct_d3_1
|
The document explicitly states that all 20 participants randomized had complete outcome data available, with no mention of missing data or differential attrition between groups. The study reports results for all enrolled participants without any indication of incomplete data.
|
low risk | |
|
Is there evidence that the result was not biased by missing outcome data?
rct_d3_2
|
The document provides some information about the study population and outcomes but lacks explicit details about missing outcome data and how it was handled. While it states that all 20 enrolled patients underwent rhinoplasty with osteotomy and had pre- and postoperative MRI scans, there is no explicit mention of whether any outcome data were missing or how such cases were addressed. The absence of this information raises some concerns about potential bias from missing data.
|
some concerns | |
|
Could missingness in the outcome depend on its true value?
rct_d3_3
|
The document does not explicitly address whether missingness in the outcome could depend on its true value. There is no mention of missing data, reasons for missing data, or how missing data were handled in the analysis. The study reports that all 20 enrolled patients completed the study with no dropouts mentioned, but this does not provide evidence about potential dependency of missingness on the outcome value.
|
some concerns | |
|
Was the method of measuring the outcome inappropriate?
rct_d4_1
|
The method of measuring the outcome (postoperative edema) is explicitly described as using pre- and postoperative magnetic resonance imaging (MRI) scans, with specific measurement protocols and blinded assessors. This method is objective and quantifiable, addressing the criterion of appropriateness directly.
|
low risk | |
|
Could measurement or ascertainment of the outcome have differed between intervention groups?
rct_d4_2
|
The document provides explicit evidence that outcome measurement methods were identical between intervention groups. The MRI scanning protocol was standardized for all patients, and the neuroradiologists assessing the scans were blinded to group assignments.
|
low risk | |
|
Were outcome assessors aware of the intervention received by study participants?
rct_d4_3
|
The document explicitly states that outcome assessors were blinded to the patients' group assignments, which directly addresses the criterion of whether outcome assessors were aware of the intervention received by study participants. This is a clear and unambiguous statement that meets the Cochrane RoB 2.0 standard for low risk of bias in this domain.
|
low risk | |
|
Could assessment of the outcome have been influenced by knowledge of intervention received?
rct_d4_4
|
The study explicitly states that the outcome assessment was performed by staff neuroradiologists who were blinded to the patients' group assignments, which minimizes the risk of bias in outcome assessment. The outcome (postoperative edema) was measured objectively using MRI scans, and the assessors were unaware of the intervention received by each patient.
|
low risk | |
|
Were the data that produced this result analyzed in accordance with a pre-specified analysis plan?
rct_d5_1
|
The document does not explicitly mention a pre-specified analysis plan or protocol. While the methods section describes the analysis performed ('A factorial analysis of variance was used to compare differences between drug and control groups'), there is no reference to whether this was pre-specified or if any deviations occurred from a planned analysis. The absence of explicit information about a pre-specified analysis plan raises some concerns about potential bias in the analysis.
|
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
|
The study explicitly states the primary outcome measurement (postoperative edema quantified as the difference in soft tissue thickness between pre- and postoperative MRI scans) and reports results for this outcome. There is no indication of selective reporting from multiple eligible outcome measurements.
|
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 states the primary outcome measure (postoperative edema quantified as the difference in soft tissue thickness between pre- and postoperative MRI scans) and reports the results for this outcome. There is no indication of selective reporting of analyses or outcomes. The methods section clearly describes the analysis approach (factorial analysis of variance) and the results are presented for the pre-specified outcome.
|
low risk |