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[New Developments in CKD-MBD. How can we produce useful evidence-based guidelines in the field of CKD-MBD?]
1Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine, Japan.
Insights
Current CKD-MBD guidelines rely on observational studies for target ranges. More randomized controlled trials (RCTs) are needed to establish evidence-based treatment intensity rather than fixed laboratory targets for better patient outcomes.
Area of Science:
- Nephrology
- Clinical Guidelines
- Evidence-Based Medicine
Background:
- Current Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) guidelines utilize target ranges for laboratory measures like calcium and phosphorus.
- These ranges are primarily derived from observational studies correlating lab values with mortality.
Purpose of the Study:
- To highlight the discrepancy between observational study findings and randomized controlled trials (RCTs) regarding optimal laboratory target ranges.
- To advocate for a paradigm shift in guideline development from setting fixed targets to comparing treatment intervention intensity.
Main Methods:
- Review of existing literature comparing observational studies and RCTs in guideline development.
- Discussion of the limitations of observational data in establishing therapeutic targets.
- Proposal for alternative analytical methods for observational studies when RCTs are infeasible.
Main Results:
- Observational studies and RCTs often suggest different optimal ranges for laboratory measures.
- Examples, such as in diabetes mellitus, show intensive control (suggested by cohort studies) can increase mortality in RCTs.
- Fixed target ranges may not be universally applicable and can be intervention-dependent.
Conclusions:
- Meaningful clinical guidelines require robust evidence, preferably from RCTs.
- A shift towards comparing treatment intensity is necessary for developing more effective and safer guidelines.
- Advanced analytical methods in observational studies can provide valuable insights when RCTs are not feasible.
Abstract:
The target ranges of laboratory measures, such as calcium and phosphorus, in the current CKD-MBD guidelines have been mainly determined by large observational studies examining the association between laboratory values and mortality. However, the suggested optimal ranges are often different between observational studies and randomized controlled trials (RCTs) . For example, in the field of diabetes mellitus, cohort studies showed that the lower hemoglobin A1c levels were associated with better clinical outcomes. However, intensive control of blood sugar resulted in higher mortality in RCTs. In order to advocate really meaningful guidelines, we have to conduct many RCTs. In other words, a paradigm shift from "setting targets" to "comparing the intensity of a medical treatment" is necessary, because target ranges might be dependent on the type of the drug or intervention. If we cannot conduct RCTs because of ethical reasons or economic issues, sophisticated analysis methods such as propensity score-based analysis and facility-level analysis should be employed in observational studies.
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