Core outcomes in neonatology: working with patients, parents and clinicians to reduce research waste

Session: 

Oral session: Patient or healthcare consumers involvement and shared decision-making (5)

Date: 

Sunday 16 September 2018 - 16:00 to 16:20

Location: 

Carrick 2

All authors in correct order:

Webbe J1, Wills-Eve B2, Modi N1, Gale C1
1 Imperial College London, United Kingdom
2 Former Neonatal Patient, United Kingdom
Presenting author and contact person

Presenting author:

James Webbe

Contact person:

James Webbe
Abstract text
Background:
Worldwide, 1 in 10 newborn babies needs admission to a neonatal unit. Neonatal research typically involves different outcomes using measures at a variety of time points. This can impede meta-analysis and is wasteful; for example, over 50% of recent neonatal Cochrane Reviews are inconclusive. Additionally, researchers select outcomes but patients and parents may have different priorities.

Objectives:
To develop a neonatal core outcomes set with broad stakeholder input.

Methods:
We formed a steering group with representatives from parents, former patients, healthcare professionals and researchers. We systematically reviewed outcomes reported in neonatal trials and identified those of importance to all stakeholders through a systematic review of qualitative studies. We entered the identified outcomes into a three-round international eDelphi survey. We recruited stakeholders online with a minimum target of 120 participants. We prospectively registered the project with COMET and published the protocol.

Results:
We identified 104 outcomes; 413 people registered to participate in the Delphi process (250 parents/former patients; 54 nurses/allied healthcare professionals; 78 doctors; 31 neonatal researchers) from 25 countries and 6 continents. After three Delphi rounds 16 outcomes reached pre-specified criteria for inclusion in the core outcomes set (survival, sepsis, necrotising enterocolitis, brain injury on imaging, retinopathy of prematurity, general gross motor ability, general cognitive ability, visual impairment, pain, quality of life, hearing impairment, seizures, medical errors, surgery).

Conclusions:
The core outcome set for neonatology will assist in standardising outcomes and selecting those relevant to groups most affected by neonatal care. Future work will clarify how outcomes should be measured. This will facilitate systematic reviews and meta-analyses and help translate research into improvements in care.

Patient or healthcare consumer involvement:
Former patients, parents and Bliss (the national UK charity for babies born sick or early) were involved in developing this research from the outset. Parents and patients are on the project steering committee, determined the scope of the project and participated in the study eDelphi process and final consensus meeting.

Relevance to patients and consumers: 

“Many parents make the difficult decision to enrol their baby into a research study not only to the potential benefit of their baby, but to improve the future prospects for others. However, many research studies record different measures or may record the same ones in different ways, making it impossible to compare studies and assess whether care was improved. Developing a ‘Core Outcomes Set’ ensures that research studies must measure all of the variables within the set and measure them in a comparable way, making it possible for research to improve future care for others.” Ben Wills-Eve, Former neonatal patient