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Review article: Patient-level outcomes: the missing link.

Denise V O'Shaughnessy¹, Grahame J Elder

¹Renal Resource Centre, Sydney Dialysis Centre, Darling Point, Sydney, New South Wales, Australia.

Nephrology (Carlton, Vic.)

|July 1, 2009

Summary

Chronic kidney disease (CKD) treatments must prioritize patient quality of life. Incorporating patient-reported outcomes into clinical research is crucial for effective CKD mineral and bone disorder therapies.

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Area of Science:

Nephrology
Clinical Research Methodology

Background:

Chronic kidney disease (CKD) significantly impacts patients' lives, particularly the elderly with comorbidities.
Therapies for CKD, especially mineral and bone disorders, often focus on survival, potentially overlooking quality of life.
Limited randomized controlled trials (RCTs) exist for renal medicine, with a reliance on intermediate endpoints.

Purpose of the Study:

To highlight the importance of patient-level outcomes in CKD treatment and research.
To advocate for the inclusion of health-related quality of life (HRQoL) measures in clinical trials.
To provide practical guidance on using validated instruments for measuring HRQoL and functional status.

Main Methods:

Review of existing literature on CKD treatment and clinical trial methodologies.
Identification and exemplification of reliable, validated instruments for measuring HRQoL and functional status.
Discussion of the integration of these measures into RCTs for CKD mineral and bone disorder treatments.

Main Results:

Data supporting patient-level outcomes for CKD therapies, particularly for mineral and bone disorders, remains limited.
RCTs in renal medicine are less common than in other specialties, often relying on surrogate markers.
Validated instruments for measuring HRQoL and functional status are available and can be readily incorporated into trials.

Conclusions:

Patient-level outcomes, including HRQoL, are essential for a comprehensive approach to CKD care.
Incorporating patient-reported outcomes should become standard practice in renal medicine and clinical research.
This approach can lead to more relevant and meaningful therapies for patients with CKD.