Core Outcome Measures in Effectiveness Trials

A CORE outcome set for studies on congenital Zika virus infection in infants and children

General Information

Summary:
It is thought that Zika virus causes a severe neurodisabiling syndrome with severe microcephaly, abnormal brain development, congenital abnormalities, epilepsy, hearing and vision problems. Exposure to Zika virus may also cause more subtle neurodevelopmental, cognitive and behavioural abnormalities presenting at pre-school and school age but we have little evidence of this to date.

At present, a heterogenous group of tools are being used to assess neurodevelopmental outcomes for Zika virus. Tools vary in what they measure, the age range of children assessed and the adaptation, validation and reliability of those measures. These include developmental tools such as the Bayley III which are expensive to use, requires 2 weeks of training and is very biased towards US populations. There is no consensus as to which tests are most universally feasible, reliable and discriminatory in the culturally diverse low, middle and high-income settings where Zika virus is present.

This lack of consensus prevents us from being able to gather and compare data for the characterisation of congenital Zika virus infection postnatally as well as into pre-school and school-age 6.

It is vital that an expert consensus is completed to determine which core assessments should be conducted on all children in all studies. This consensus is urgently needed so that data collection on the effect of Zika virus on infant and child neurodevelopmental outcomes is comparable and consistent across countries2. Creation of a CORE outcome set with an agreed standardized collection of outcomes will reduce heterogeneity and outcome reporting bias7 89 and enable meta-analysis and sharing of data across studies.

Contributors:
Dr Melissa Gladstone - Principal Investigator
Prof Paula Williamson - Professor of Biostatistics University of Liverpool
Yiovanna Derpsch - Research associate neurodevelopmental paediatrics
Pratik Rai - research student neurodevelopmental paediatrics
Gail Carson - Head of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) Coordinating Centre and Group Head, Oxford University
Dr Archana Patel – Consultant for work on neurodevelopmental screening and implementation programmes for congenital Zika (World Health Organisation)
Prof Tom Solomon - Head of Institute of Global Health, University of Liverpool
Dr Mike Griffiths - Senior Lecturer and Paediatric Neurologist, Institute of Global Health, University of Liverpool

Further Study Information

Current Stage:
Planning
Date:
April 2017 - April 2019
Funding source(s):
Funding from NIHR HPRU Emerging and Zoonotic Infections - £5000 for research assistant

Health Area

Disease Category
Child health

Disease Name
Congenital Zika Infection

Target Population

Age Range
0 - 16

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Focus group(s)
Interview
Systematic review

We aim to use this funding to generate data which will provide clear guidelines for those working in the field of Zika to measure neurodevelopmental outcomes more collaboratively and consistently.

To undertake this work we will utilise a collaborative approach and gain from existing networks which are presently working in Zika as well as in neurodevelopmental and neurodisability outcomes globally.

We have four main aims that we intend to undertake to enable us to provide consensus on what outcomes should be being measured in all studies on neurodevelopmental outcomes of children exposed to Zika virus.

Aim1 :
To develop a consensus about WHAT to measure when studying outcomes of congenital brain infections such as Zika virus.
Outcomes measured will be classified into age bands for those relevant for; 1) neonates 2) infants 3) pre-schoolers and 4) school age children.
To gain true consensus we will aim to gather views from stakeholders through the following steps:
1. Collate information from 10 interviews with parents who have children with congenital Zika virus (from Brazilian Recife network and collaborations for focus group and qualitative work with parents and professionals who are working with these children day to day.
2. Conduct an online Delphi manager survey asking other stakeholders what they consider is most important to measure in looking at neurodevelopmental outcomes in Zika virus.
3. Create a list of all potential outcomes already measured or considered important by stakeholders and conduct a 2 round electronic Delphi process to identify what neurodevelopmental domains should be being assessed and followed up for children with Zika virus.

Aim 2: To develop consensus on HOW to measure outcomes relating to congenital Zika virus.
1. Review of literature to discover the psychometric properties and training required of tools used so far that have been highlighted by the Delphi process in Aim 1.
2. To create a list of required criteria for HOW these outcomes should be scored which guided by the COSMIN checklist (COnsensusbased Standards for the selection of health Measurement Instruments, www.cosmin.nl) checklist [27] feasibility of measurement is a further consideration as well as measures of feasibility in varied settings where Zika virus outcomes are being measured.
3. Conduct a further consensus using Delphi software (two rounds) of which of a number of tools which have been chosen within domains are considered best for measuring outcomes when provided with evidence that we have to date guided by the COSMIN checklist and the feasibility criteria we have chosen. Experts will particularly include those from LMIC settings/Brazil/PAHO coutries.

Aim 3: To come to final consensus on what to measure neurodevelopmental outcomes in children who have congenitally acquired Zika or whohave been exposed to to Zika virus in utero.
a) Meeting to feedback and gain final international consensus relating to outcomes measured through Delphi process at an International ZikAlliance meeting.

Aim 4: To disseminate this consensus statement and set of CORE outcomes through our already formed networks. This will include publication of a paper on the CORE outcome set but also publication of the outcome set and the recommendations on the ISARIC and ZikAlliance websites.


Stakeholders Involved

Clinical experts
Conference participants
Consumers (patients)
Epidemiologists
Families
Governmental agencies
Researchers
Statisticians

Study Type

COS for clinical trials or clinical research
COS for practice

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