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Quality Assessment Results

Rampello_2019.pdf

Status: Completed
Document Type: Diagnostic Study
Assessment Tool: QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies) - Complete
Assessment completed!
13/13
Next check in: 5 seconds
30.8%
Overall Quality Score
4/13 criteria met

Assessment Details

Assessment Criterion AI Analysis AI Judgment Issues
Was a consecutive or random sample of patients enrolled?
ds_d1_rb1
The study does not explicitly describe the sampling method used for patient enrollment. While it states the number of patients recruited (238) and their characteristics, there is no mention of whether this was a consecutive or random sample. The retrospective observational design suggests potential for selection bias without explicit sampling methodology documentation.
no star awarded
Was a case-control design avoided?
ds_d1_rb2
The study explicitly states it is a retrospective observational study, not a case-control design, which meets the NOS criterion for avoiding case-control designs that can overestimate diagnostic accuracy. The study design is clearly described in the methods section.
star awarded
Did the study avoid inappropriate exclusions?
ds_d1_rb3
The study does not explicitly describe exclusion criteria or justify any exclusions made. While it mentions excluding other causes of neuropathy (e.g., radiculopathy, hypothyroidism), it does not provide details on how these exclusions were determined or applied. Without explicit documentation of exclusion procedures and their appropriateness, we cannot confirm that inappropriate exclusions were avoided.
no star awarded
Are there concerns that the included patients and setting do not match the review question?
ds_d1_ac1
Raw response parsing failed. Original content: ```json { "judgment": "star awarded", "scoring_rationale": "The study explicitly matches the review question regarding patient characteristics, setting, and intended use of index test. The study f...
star awarded
Were the index test results interpreted without knowledge of the results of the reference standard?
ds_d2_rb1
The document does not explicitly state whether the index test results (neurography) were interpreted without knowledge of the reference standard results (clinical neurologic assessment and nerve conduction testing). The NOS requires explicit documentation of blinding procedures for this criterion to minimize bias in interpretation.
no star awarded
If a threshold was used, was it pre-specified?
ds_d2_rb2
The document does not explicitly state whether thresholds for A wave detection were pre-specified prior to data analysis. While the study describes detailed neurographic methods and criteria for distinguishing A waves from F waves, there is no explicit mention of pre-specifying detection thresholds before conducting the study. The criteria mentioned appear to be based on established literature guidelines rather than study-specific pre-specifications.
no star awarded
Are there concerns that the index test, its conduct, or interpretation differ from the review question?
ds_d2_ac1
The document does not explicitly describe whether the index test (neurography with A wave assessment) was performed as it would be in clinical practice. While the methods section details the technical aspects of neurography and the criteria for distinguishing A waves from F waves, there is no explicit statement confirming that the test was conducted in a manner consistent with routine clinical practice. The description focuses on the research protocol rather than clinical applicability.
no star awarded
Is the reference standard likely to correctly classify the target condition?
ds_d3_rb1
The study explicitly describes the use of neurography as the reference standard for diagnosing diabetic neuropathy, which is considered the most widely used and reliable diagnostic test for peripheral nerve assessment. The diagnostic criteria are clearly stated to follow the Toronto Diabetic Neuropathy Expert Group criteria, and the methods for distinguishing between F and A waves are detailed with specific neurophysiological parameters.
star awarded
Were the reference standard results interpreted without knowledge of the results of the index test?
ds_d3_rb2
The document does not explicitly state whether the interpretation of the reference standard results (neurography) was performed without knowledge of the index test results (clinical diagnosis of diabetic neuropathy). The methods section describes the neurographic procedures and diagnostic criteria but does not mention blinding procedures for interpretation.
no star awarded
Are there concerns that the target condition as defined by the reference standard does not match the question?
ds_d3_ac1
The document does not explicitly address whether the reference standard (Toronto Diabetic Neuropathy Expert Group criteria) matches the target condition (A waves in diabetic neuropathy) as defined in the study question. While the study describes the use of neurography and late responses (F waves and A waves) for assessing diabetic neuropathy, there is no direct comparison or discussion of how the reference standard aligns with the specific focus on A waves.
no star awarded
Was there an appropriate interval between index test and reference standard?
ds_d4_rb1
The document does not explicitly state the interval between the index test (neurography) and the reference standard (clinical neurologic assessment and nerve conduction testing). Without this information, it is impossible to determine if the interval was short enough to prevent changes in the target condition (diabetic neuropathy).
no star awarded
Did all patients receive the same reference standard?
ds_d4_rb2
The study explicitly states that all patients and controls underwent the same neurographic examination protocol, including the same reference standard for assessing A waves. The methods section details the standardized procedures for nerve conduction studies and the criteria used to distinguish between F and A waves, which were applied uniformly across all participants.
star awarded
Were all patients included in the analysis?
ds_d4_rb3
The document does not explicitly state whether all patients were included in the analysis or if there were any withdrawals. There is no mention of how withdrawals were handled or whether they were explained. Without this information, it is impossible to determine if withdrawals could introduce bias.
no star awarded
Assessment Summary
13
Total Criteria
4
Criteria Met
9
Issues Found
30.8%
Quality Score

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