AMEND study protocol: A case-control study to assess the long-term impact of invasive meningococcal disease in Australian adolescents and young adults

Helen Marshall, Mark McMillan, Bing Wang, Robert Booy, Hossein Afzali, Jim Buttery, Christopher C. Blyth, Peter Richmond, David Shaw, David Gordon, Belinda Barton

Research output: Contribution to journalArticle

Abstract

Introduction Invasive meningococcal disease (IMD) primarily causes disease in young children and adolescents and can cause long-term disability. Many countries are considering implementation of meningococcal B and/or meningococcal ACWY vaccines to control meningococcal disease. Estimating the cost-effectiveness of meningococcal vaccine programme is hampered due to a lack of good quality costing and burden of disease data. This study aims to address this evidence gap by assessing the clinical, physical, neurocognitive, economic and societal impact of IMD on adolescents and young adults. Methods and analysis A case-control study of 64 participants with confirmed IMD (15-24 years 11 months at time of disease) and 64 control participants (17-34 years 11 months) will be conducted in Australia from 2016 to 2020. All participants will undergo a neurocognitive assessment, full medical examination, pure tone audiometry assessment and complete quality of life and behavioural questionnaires. Meningococcal cases will be assessed 2-10 years posthospitalisation and a subset of cases will be interviewed to explore in depth their experiences of IMD and its impact on their life. Primary outcome measures include general intellectual functioning from the Wechsler Adult Intelligence Scale and overall quality of life from the Health Utilities Index. Secondary outcome measures include academic achievement, executive functioning, behaviour, hearing, psychological and physical functioning. Outcome measures will be compared between cases and controls using independent t-tests or ORs, or if any significant confounders are identified, adjusted analyses (analysis of covariance or adjusted ORs) will be conducted. Thematic analysis will be used to analyse transcribed interviews and a costing model will be used to project lifetime costs. Ethics and dissemination The Adolescent MENingococcal Disease (AMEND) study has been approved by the Human Research Ethics Committee of the Women's and Children's Health Network (HREC/14/WCHN/024). The results will be disseminated via peer-reviewed publications, conference presentations, study participants, and meningococcal and meningitis foundations. Trial registration number NCT03798574.

Original languageEnglish
Article numbere032583
JournalBMJ Open
Volume9
Issue number12
DOIs
Publication statusPublished - 29 Dec 2019

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Case-Control Studies
Young Adult
Meningococcal Vaccines
Outcome Assessment (Health Care)
Quality of Life
Meningococcal Meningitis
Pure-Tone Audiometry
Research Ethics Committees
Women's Health
Intelligence
Ethics
Hearing
Cost-Benefit Analysis
Publications
Economics
Interviews
Psychology
Costs and Cost Analysis
Health

Cite this

Marshall, Helen ; McMillan, Mark ; Wang, Bing ; Booy, Robert ; Afzali, Hossein ; Buttery, Jim ; Blyth, Christopher C. ; Richmond, Peter ; Shaw, David ; Gordon, David ; Barton, Belinda. / AMEND study protocol : A case-control study to assess the long-term impact of invasive meningococcal disease in Australian adolescents and young adults. In: BMJ Open. 2019 ; Vol. 9, No. 12.
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abstract = "Introduction Invasive meningococcal disease (IMD) primarily causes disease in young children and adolescents and can cause long-term disability. Many countries are considering implementation of meningococcal B and/or meningococcal ACWY vaccines to control meningococcal disease. Estimating the cost-effectiveness of meningococcal vaccine programme is hampered due to a lack of good quality costing and burden of disease data. This study aims to address this evidence gap by assessing the clinical, physical, neurocognitive, economic and societal impact of IMD on adolescents and young adults. Methods and analysis A case-control study of 64 participants with confirmed IMD (15-24 years 11 months at time of disease) and 64 control participants (17-34 years 11 months) will be conducted in Australia from 2016 to 2020. All participants will undergo a neurocognitive assessment, full medical examination, pure tone audiometry assessment and complete quality of life and behavioural questionnaires. Meningococcal cases will be assessed 2-10 years posthospitalisation and a subset of cases will be interviewed to explore in depth their experiences of IMD and its impact on their life. Primary outcome measures include general intellectual functioning from the Wechsler Adult Intelligence Scale and overall quality of life from the Health Utilities Index. Secondary outcome measures include academic achievement, executive functioning, behaviour, hearing, psychological and physical functioning. Outcome measures will be compared between cases and controls using independent t-tests or ORs, or if any significant confounders are identified, adjusted analyses (analysis of covariance or adjusted ORs) will be conducted. Thematic analysis will be used to analyse transcribed interviews and a costing model will be used to project lifetime costs. Ethics and dissemination The Adolescent MENingococcal Disease (AMEND) study has been approved by the Human Research Ethics Committee of the Women's and Children's Health Network (HREC/14/WCHN/024). The results will be disseminated via peer-reviewed publications, conference presentations, study participants, and meningococcal and meningitis foundations. Trial registration number NCT03798574.",
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AMEND study protocol : A case-control study to assess the long-term impact of invasive meningococcal disease in Australian adolescents and young adults. / Marshall, Helen; McMillan, Mark; Wang, Bing; Booy, Robert; Afzali, Hossein; Buttery, Jim; Blyth, Christopher C.; Richmond, Peter; Shaw, David; Gordon, David; Barton, Belinda.

In: BMJ Open, Vol. 9, No. 12, e032583, 29.12.2019.

Research output: Contribution to journalArticle

TY - JOUR

T1 - AMEND study protocol

T2 - A case-control study to assess the long-term impact of invasive meningococcal disease in Australian adolescents and young adults

AU - Marshall, Helen

AU - McMillan, Mark

AU - Wang, Bing

AU - Booy, Robert

AU - Afzali, Hossein

AU - Buttery, Jim

AU - Blyth, Christopher C.

AU - Richmond, Peter

AU - Shaw, David

AU - Gordon, David

AU - Barton, Belinda

PY - 2019/12/29

Y1 - 2019/12/29

N2 - Introduction Invasive meningococcal disease (IMD) primarily causes disease in young children and adolescents and can cause long-term disability. Many countries are considering implementation of meningococcal B and/or meningococcal ACWY vaccines to control meningococcal disease. Estimating the cost-effectiveness of meningococcal vaccine programme is hampered due to a lack of good quality costing and burden of disease data. This study aims to address this evidence gap by assessing the clinical, physical, neurocognitive, economic and societal impact of IMD on adolescents and young adults. Methods and analysis A case-control study of 64 participants with confirmed IMD (15-24 years 11 months at time of disease) and 64 control participants (17-34 years 11 months) will be conducted in Australia from 2016 to 2020. All participants will undergo a neurocognitive assessment, full medical examination, pure tone audiometry assessment and complete quality of life and behavioural questionnaires. Meningococcal cases will be assessed 2-10 years posthospitalisation and a subset of cases will be interviewed to explore in depth their experiences of IMD and its impact on their life. Primary outcome measures include general intellectual functioning from the Wechsler Adult Intelligence Scale and overall quality of life from the Health Utilities Index. Secondary outcome measures include academic achievement, executive functioning, behaviour, hearing, psychological and physical functioning. Outcome measures will be compared between cases and controls using independent t-tests or ORs, or if any significant confounders are identified, adjusted analyses (analysis of covariance or adjusted ORs) will be conducted. Thematic analysis will be used to analyse transcribed interviews and a costing model will be used to project lifetime costs. Ethics and dissemination The Adolescent MENingococcal Disease (AMEND) study has been approved by the Human Research Ethics Committee of the Women's and Children's Health Network (HREC/14/WCHN/024). The results will be disseminated via peer-reviewed publications, conference presentations, study participants, and meningococcal and meningitis foundations. Trial registration number NCT03798574.

AB - Introduction Invasive meningococcal disease (IMD) primarily causes disease in young children and adolescents and can cause long-term disability. Many countries are considering implementation of meningococcal B and/or meningococcal ACWY vaccines to control meningococcal disease. Estimating the cost-effectiveness of meningococcal vaccine programme is hampered due to a lack of good quality costing and burden of disease data. This study aims to address this evidence gap by assessing the clinical, physical, neurocognitive, economic and societal impact of IMD on adolescents and young adults. Methods and analysis A case-control study of 64 participants with confirmed IMD (15-24 years 11 months at time of disease) and 64 control participants (17-34 years 11 months) will be conducted in Australia from 2016 to 2020. All participants will undergo a neurocognitive assessment, full medical examination, pure tone audiometry assessment and complete quality of life and behavioural questionnaires. Meningococcal cases will be assessed 2-10 years posthospitalisation and a subset of cases will be interviewed to explore in depth their experiences of IMD and its impact on their life. Primary outcome measures include general intellectual functioning from the Wechsler Adult Intelligence Scale and overall quality of life from the Health Utilities Index. Secondary outcome measures include academic achievement, executive functioning, behaviour, hearing, psychological and physical functioning. Outcome measures will be compared between cases and controls using independent t-tests or ORs, or if any significant confounders are identified, adjusted analyses (analysis of covariance or adjusted ORs) will be conducted. Thematic analysis will be used to analyse transcribed interviews and a costing model will be used to project lifetime costs. Ethics and dissemination The Adolescent MENingococcal Disease (AMEND) study has been approved by the Human Research Ethics Committee of the Women's and Children's Health Network (HREC/14/WCHN/024). The results will be disseminated via peer-reviewed publications, conference presentations, study participants, and meningococcal and meningitis foundations. Trial registration number NCT03798574.

KW - adolescents

KW - health economics

KW - immunisation programs

KW - meningococcal disease

KW - neurocognitive

KW - sequelae

KW - young adults

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SN - 2044-6055

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