Core Outcome Measures in Effectiveness Trials

Clinicians' and researchers' perspectives on establishing and implementing core outcomes in haemodialysis: semistructured interview study

General Information

OBJECTIVES: To describe the perspectives of clinicians and researchers on identifying, establishing and implementing core outcomes in haemodialysis and their expected impact. DESIGN: Face-to-face, semistructured interviews; thematic analysis. STETTING: Twenty-seven centres across nine countries. PARTICIPANTS: Fifty-eight nephrologists (42 (72%) who were also triallists). RESULTS: We identified six themes: reflecting direct patient relevance and impact (survival as the primary goal of dialysis, enabling well-being and functioning, severe consequences of comorbidities and complications, indicators of treatment success, universal relevance, stakeholder consensus); amenable and responsive to interventions (realistic and possible to intervene on, differentiating between treatments); reflective of economic burden on healthcare; feasibility of implementation (clarity and consistency in definition, easily measurable, requiring minimal resources, creating a cultural shift, aversion to intensifying bureaucracy, allowing justifiable exceptions); authoritative inducement and directive (endorsement for legitimacy, necessity of buy-in from dialysis providers, incentivising uptake); instituting patient-centredness (explicitly addressing patient-important outcomes, reciprocating trial participation, improving comparability of interventions for decision-making, driving quality improvement and compelling a focus on quality of life). CONCLUSIONS: Nephrologists emphasised that core outcomes should be relevant to patients, amenable to change, feasible to implement and supported by stakeholder organisations. They expected core outcomes would improve patient-centred care and outcomes.

Tong, A. Crowe, S. Gill, J. S. Harris, T. Hemmelgarn, B. R. Manns, B. Pecoits-Filho, R. Tugwell, P. van Biesen, W. Wang, A. Y. M. Wheeler, D. C. Winkelmayer, W. C. Gutman, T. Ju, A. O'Lone, E. Sautenet, B. Viecelli, A. Craig, J. C.


BMJ Open
e021198 -
Further Study Information

May 2015 - October 2015
Funding source(s):
National Health and Medical Research Council (NHMRC) Project Grant (APP1098815). AT is supported by a NHMRC Career Development Fellowship (APP1106716). AV receives grant support from the NHMRC Medical Postgraduate Scholarship (APP1114539) and the Royal Australasian College of Physicians (Jacquot NHMRC Award for Excellence). EO’L receives grant support from the NHMRC Medical Postgraduate Scholarship (APP1114539).

Health Area

Disease Category
Kidney disease

Disease Name
Chronic kidney disease

Target Population

Age Range


Nature / type of Intervention



Stakeholders Involved

Clinical experts

Study Type

COS for clinical trials or clinical research
COS for practice

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