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Goldstein KM, Lunyera J, Mohottige D, et al. Risk of Nephrogenic Systemic Fibrosis after Exposure to Newer Gadolinium Agents [Internet]. Washington (DC): Department of Veterans Affairs (US); 2019 Oct.

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Risk of Nephrogenic Systemic Fibrosis after Exposure to Newer Gadolinium Agents [Internet].

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APPENDIX HGlossary

For full study citations in this appendix, please refer to the report’s main reference list.

TermDefinition
Certainty of evidence (COE)We assessed COE using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach32 for 4 domains:
DomainRatingHow Assessed
Risk of bias

Low

Unclear

High

Assessed primarily through study design and aggregate study quality
Consistency

Not serious inconsistency

Serious inconsistency

Very serious inconsistency

Assessed primarily through whether effect sizes are generally on the same side of “no effect,” the overall range of effect sizes, and statistical measures of heterogeneity
Directness

Not indirect

Serious indirectness

Very serious indirectness

Assessed by whether the evidence involves direct comparisons or indirect comparisons through use of surrogate outcomes or use of separate bodies of evidence
Precision

Not serious imprecision

Serious imprecision

Very serious imprecision

Based primarily on the size of the confidence intervals of effect estimates, the optimal information size and considerations of whether the confidence interval crossed a clinical decision threshold

Summary COE ratings for a body of evidence:
  • High—High confidence that the true effect lies close to that of the estimate of the effect.
  • Moderate—Moderate confidence in the effect estimate. The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
  • Low—Limited confidence in the effect estimate. The true effect may be substantially different from the estimate of the effect.
  • Very low—Very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate of effect.
  • Insufficient—Impossible or imprudent to rate. In these situations, a rating of insufficient is assigned.
Chronic kidney disease stages
  • Stage 1 with normal or high estimated glomerular filtration rate (eGFR): eGFR >90 mL/min
  • Stage 2 Mild CKD: eGFR = 60-89 mL/min
  • Stage 3A Moderate CKD: eGFR = 45-59 mL/min
  • Stage 3B Moderate CKD: eGFR = 30-44 mL/min
  • Stage 4 Severe CKD: eGFR = 15-29 mL/min
  • Stage 5 End-Stage CKD: eGFR <15 mL/min
Index exposureThe only gadolinium contrast agent exposure as reported by the study, or the primary exposure for studies in which patients were exposed to multiple gadolinium-based contrast agents (ie, confounded exposures).
Objective outcomes (ie, non–patient-reported outcomes)Outcomes that are not subject to a large degree of individual interpretation and are likely to be reliably measured across patients in a study, by different health care providers, and over time.
Patient-reported outcomesOutcomes that are directly reported by the patient without interpretation of the patient’s response by a clinician or anyone else and pertains to the patient’s health, quality of life, or functional status associated with health care or treatment.
Risk of bias (ROB)An assessment of study quality. In this report, we used the Cochrane EPOC ROB tool, which is applicable to randomized and nonrandomized studies29:
  • Randomization and allocation concealment
  • Comparability of groups at baseline
  • Blinded outcomes assessment
  • Completeness of follow-up and differential loss to follow-up
  • Whether incomplete data were addressed appropriately
  • Protection against contamination
  • Selective outcomes reporting
  • Intervention independent from other changes (specific to interrupted time series)
  • Intervention pre-specified (specific to interrupted time series)
  • Intervention affect on data collection (specific to interrupted time series)

Summary ROB ratings for a study:
  • Low ROB—Bias, if present, is unlikely to alter the results seriously
  • Unclear ROB—Bias that raises some doubts about the results
  • High ROB—Bias that may alter the results seriously

For observational cohort and case-control studies, we adapted the Newcastle-Ottawa ROB scale (from the version modified by Guyatt and colleagues). For documentation and tools, refer to Evidence Partners’ Methodological Resources at https://www.evidencepartners.com/resources/methodological-resources/.
Copyright Notice

This publication is in the public domain and is therefore without copyright. All text from this work may be reprinted freely. Use of these materials should be acknowledged.

Bookshelf ID: NBK559363
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