Core Outcome Measures in Effectiveness Trials

Identifying critically important vascular access outcomes for trials in haemodialysis: an international survey with patients, caregivers and health professionals

General Information

Abstract:
BACKGROUND: Vascular access outcomes reported across haemodialysis (HD) trials are numerous, heterogeneous and not always relevant to patients and clinicians. This study aimed to identify critically important vascular access outcomes. METHOD: Outcomes derived from a systematic review, multi-disciplinary expert panel and patient input were included in a multilanguage online survey. Participants rated the absolute importance of outcomes using a 9-point Likert scale (7-9 being critically important). The relative importance was determined by a best-worst scale using multinomial logistic regression. Open text responses were analysed thematically. RESULTS: The survey was completed by 873 participants [224 (26%) patients/caregivers and 649 (74%) health professionals] from 58 countries. Vascular access function was considered the most important outcome (mean score 7.8 for patients and caregivers/8.5 for health professionals, with 85%/95% rating it critically important, and top ranked on best-worst scale), followed by infection (mean 7.4/8.2, 79%/92% rating it critically important, second rank on best-worst scale). Health professionals rated all outcomes of equal or higher importance than patients/caregivers, except for aneurysms. We identified six themes: necessity for HD, applicability across vascular access types, frequency and severity of debilitation, minimizing the risk of hospitalization and death, optimizing technical competence and adherence to best practice and direct impact on appearance and lifestyle. CONCLUSIONS: Vascular access function was the most critically important outcome among patients/caregivers and health professionals. Consistent reporting of this outcome across trials in HD will strengthen their value in supporting vascular access practice and shared decision making in patients requiring HD.

Authors:
Viecelli, A. K. Howell, M. Tong, A. Teixeira-Pinto, A. O'Lone, E. Ju, A. Craig, J. C. Hooi, L. S. Lee, T. Lok, C. E. Polkinghorne, K. R. Quinn, R. R. Vachharajani, T. J. Vanholder, R. Zuo, L. Tordoir, J. Pecoits-Filho, R. Yuo, T. Kopperschmidt, P. Smith, R. Irish, A. B. Mori, T. A. Pascoe, E. M. Johnson, D. W. Hawley, C. M.

Publication

Journal:
Nephrol Dial Transplant
Volume:
Issue:
Pages:
-
Year:
2019
DOI:
Further Study Information

Date:
Funding source(s):

Health Area

Disease Category
Kidney disease

Disease Name
Chronic kidney disease

Target Population

Age Range
-

Sex
Either


Nature / type of Intervention
Procedure

Method(s)

Survey

Outcomes derived from a systematic review, multi-disciplinary expert panel and patient input were included in a multilanguage online survey. Participants rated the absolute importance of outcomes using a 9-point Likert scale (7–9 being critically important). The relative importance was determined by a best–worst scale using multinomial logistic regression. Open text responses were analysed thematically.


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)

Study Type

COS for clinical trials or clinical research
Recommended outcome measures (measurement)

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