Background
'General cognitive ability' was identified as a core outcome for neonatal research in a consensus project involving over 400 former patients, parents, healthcare workers and researchers. Difficulties at school has been recognised as an important sequela of neonatal illness, and was the major problem self-reported by adolescents born with extremely low birth weight. Regrettably, there is no consensus over how general cognitive ability should be reported in neonatal research: it is reported at a number of different time points using a variety of measurement instruments which inhibits synthesis of trial results in meta-analyses. Furthermore, former patients and parents have expressed concerns that the tools used to report this concept may not relate well to the lives of former neonatal patients. These issues limit the progress made to improve general cognitive ability in former neonatal patients.
Objective
To identify a pragmatic outcome measure and measurement time point for 'general cognitive ability' for research involving infants receiving neonatal care in a high-income setting.
Design
A steering group that includes parents and former patients, healthcare professionals and researchers will be formed to guide the identification of the outcome measure and time point. We will systematically review neonatal trials systematically to identify previously reported outcome measures and time points used to report general cognitive ability. Additionally, we will specifically identify outcome measures and time points relating to general cognitive ability relevant to former patients, parents, and healthcare professionals through a systematic review of qualitative studies. The validity and reliability of the outcome measures and measurement time points identified will be assessed against COSMIN criteria. All outcome measures identified will be entered into an international, multi-perspective three-round eDelphi survey. All key stakeholders will be invited to participate (including former neonatal patients, parents, healthcare workers and researchers). The Delphi method will encourage individual and group stakeholder consensus to agree a single outcome measure and time point that is feasible for all neonatal research.
A consensus meeting will be held to confirm the final outcome measure and measurement timepoint, based on the survey results.
Conclusions and relevance
Agreeing a single outcome measure and measurement time point that is feasible for all neonatal research will ensure that future research produces results that are meaningful to key stakeholders (including former patients and parents), and are recorded and reported in a standardised fashion facilitating future evidence syntheses. This will help to ensure that all research contributes information to improve neonatal care and ensure future patients have improved general cognitive ability.
Principal investigator:
Dr James Webbe (Imperial College London)
Co-investigators:
Prof Elaine Boyle (University of Leicester)
Prof Samantha Johnson (University of Leicester)
Dr Cheryl Battersby (Imperial College London)
Prof Neena Modi (Imperial College London)
Prof Chris Gale (Imperial College London)
Disease Category: Neonatal care
Disease Name: Neonatal care
Age Range: 0 - 0
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Families
- Methodologists
- Patient/ support group representatives
- Researchers
- Service providers
- Service users
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Systematic review
A steering group that includes parents and former patients, healthcare professionals and researchers will be formed to guide the identification of the outcome measure and time point.
We will systematically review neonatal trials systematically to identify previously reported outcome measures and time points used to report general cognitive ability. Additionally, we will specifically identify outcome measures and time points relating to general cognitive ability relevant to former patients, parents, and healthcare professionals through a systematic review of qualitative studies. The validity and reliability of the outcome measures and measurement time points identified will be assessed against COSMIN criteria. All outcome measures identified will be entered into an international, multi-perspective three-round eDelphi survey. All key stakeholders will be invited to participate (including former neonatal patients, parents, healthcare workers and researchers). The Delphi method will encourage individual and group stakeholder consensus to agree a single outcome measure and time point that is feasible for all neonatal research.
A consensus meeting will be held to confirm the final outcome measure and measurement timepoint, based on the survey results.