Core Outcome Measures in Effectiveness Trials

Core outcome set for children with neurological impairment and tube feeding

General Information

Aim To develop a core outcome set (COS) for evaluating gastrostomy/gastrojejunostomy tube impact in children with neurological impairment. Method Healthcare providers/researchers and caregivers rated the importance of candidate outcomes on a 5-point Likert scale. Outcomes rated ‘somewhat important’ or ‘very important’ by most (=85%) respondents were voted on during a consensus meeting. Outcomes that reached consensus for inclusion were ratified and assigned to Outcome Measures in Rheumatology filter core areas. The COS was validated in a separate group of caregivers. Results Twelve outcomes were selected from 120 candidate outcomes to form the COS. These included five ‘Life Impact’ outcomes, three ‘Pathophysiological Manifestations’ outcomes, two ‘Resource Use’ outcomes, one ‘Growth and Development’ outcome, and one ‘Death’ outcome. Interpretation We developed an evidence-informed and consensus-based COS for use in studies of gastrostomy/gastrojejunostomy tube feeding in children with neurological impairment. Implementation of this COS will help reduce heterogeneity between studies and facilitate evidence-based decision-making. What this paper adds Caregivers, healthcare providers, and researchers ranked the importance of 120 outcomes. Twelve core outcomes were identified as essential to measure in future clinical research studies.

Joachim, Kariym C Farid-Kapadia, Mufiza Butcher, Nancy J Chee-a-tow, Alyssandra Monsour, Andrea Cohen, Eyal Mahant, Sanjay Guttmann, Astrid Offringa, Martin the Complex Care COS Consensus Meeting Group


Developmental Medicine & Child Neurology
Further Study Information

September 2014 - May 2019
Funding source(s):
Norman Saunders Complex Care Initiative Grant Competition 2014; grant #1000041135. Astrid Guttmann receives salary support from a Canadian Institutes for Health Research Applied Chair in Child Health Services Research.

Health Area

Disease Category
Child health

Disease Name

Target Population

Age Range
0 - 18


Nature / type of Intervention


Consensus meeting
Delphi process
Systematic review

The development of this COS followed established COS development recommendations:
i) a systematic review to generate a list of categorized potential outcomes for inclusion in the COS (;
ii) a consensus building process that engages key stakeholders involved in the care and/or research of these children (i.e., healthcare providers, researchers, and primary caregivers) to prioritize outcomes for inclusion in the COS, and
iii) a consensus meeting to further refine and finalize the COS. Outcomes that reached consensus for inclusion were ratified and assigned to OMERACT Filter 2.0 core areas. A validation phase with a separate primary caregiver group was also completed.

Stakeholders Involved

Clinical experts
Consumers (caregivers)

Study Type

COS for clinical trials or clinical research

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