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Jul 10

Validation of the PROMIS-57. PROMIS-43 and PROMIS-29 Profile in Patients with Chronic Kidney Disease (UHN 15-9645-AE)

Patient-reported outcomes (PROs), such as symptoms, health- related quality of life (HRQOL), or satisfaction with care, are reported directly by the patient, without interpretation by the clinician or a family member/caregiver. These outcomes inform clinicians and researchers about patient’s challenges and sources of suffering, and they provide information that supplements “traditional” clinical outcomes, such as mortality or hospitalization. PROs are valued by patients, clinicians, and policy-makers. They inform therapeutic choices, disease management practices, reimbursement decisions, and health policy.

Recently, the National Institute of Health (NIH) sponsored an initiative called the Patient Reported Outcomes Measurement Information System (PROMIS) with the aim of developing universally valid tools to measure PROs that address many of the challenges that are currently faced.  The PROMIS profile instruments (PROMIS-57, PROMIS-43 and PROMIS-29 adult profile) have not been validated in patients with chronic kidney disease (CKD). 

Therefore, in this study we will validate these instruments within this patient population. We will recruit a total of 450-500 patients (both patients on dialysis, with earlier stages of CKD and kidney transplant recipients). We are administering a number of validated, standard questionnaires that are currently used to assess the complex dimensions emotional distress along with the PROMIS questionnaire:

  • Kidney Disease Quality of Life (KDQoL) questionnaire;
  • Patient Health Questionnaire (PHQ9) for depression;
  • General Anxiety Disorder (GAD7) for anxiety;
  • Social Difficulties Inventory (SDI).

Internal reliability, test-retest reliability, convergent validity and known group comparisons will be tested.

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