title: Exploring neurodevelopmental outcome measures used in children with cerebral malaria: the perspectives of caregivers and health workers in Malawi.
abstract: Progress has been made in tackling malaria however there are still over 207 million cases worldwide, the majority in children. As survival rates improve, numbers of children with long-term neurodisabling sequelae are likely to increase. Most outcome studies in cerebral malaria (CM) have focused only on body function and structure and less on outcomes within the broader framework of the International Classification of Functioning and Disability (ICF). The aim of this study was to utilise qualitative methods to identify relevant clinical outcomes in CM to support formulation of a core outcome set relevant to CM and other acquired brain injuries for use in future clinical trials.
  
  
  
  In depth interviews with parent/caregivers (CGs) of children with/without previous CM (N = 19), and in depth interviews with health professionals (N = 18) involved in their care were conducted in community and clinical settings in and around Blantyre, Malawi. Interviews were audio taped, transcribed, translated and a thematic content analysis was conducted. Themes were categorised and placed firstly in an iterative framework derived from the data but then within the ICF framework.
  
  
  
  Outcomes perceived as important to carers and professionals fulfilled each level of the ICF. These included impairment in body function and structure (contractures, impaired mobility, visual problems, seizures, cognitive function and feeding); activity and participation outcomes (learning, self-care, relationships in school, play and activities of daily living). Other issues emerging included the social and emotional implications of CM on the family, and balancing care of children with neurodisability with demands of daily life, financial pressures, and child protection. Themes of stigma and discrimination were described; these were perceived to negatively influence care, participation and integration of carer and child into the community.
  
  
  
  Outcomes considered important for parents/caregivers and professionals working with children post CM cross all aspects of the ICF framework (impairment, functioning and participation). Outcomes emphasised by families and carers in cross-cultural settings must be given adequate attention when conducting clinical studies in these settings.
authors.affiliation: Malawi-Liverpool Wellcome Trust Clinical Research Programme, PO Box 30096, Chichiri, Blantyre, 3, Malawi.|Paediatric department, University of Malawi, College of Medicine, P/Bag 360, Blantyre, 3, Malawi.
authors.forename: Emmie W
authors.initials: EW
authors.lastname: Mbale
authors.affiliation: College of Osteopathic Medicine, Michigan State University, East Lansing, MI, USA.|Blantyre Malaria Project, University of Malawi College of Medicine, Blantyre, Malawi.
authors.forename: Terrie
authors.initials: T
authors.lastname: Taylor
authors.affiliation: Clinical Sciences Division, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, UK.
authors.forename: Bernard
authors.initials: B
authors.lastname: Brabin
authors.affiliation: Malawi-Liverpool Wellcome Trust Clinical Research Programme, PO Box 30096, Chichiri, Blantyre, 3, Malawi.|Paediatric department, University of Malawi, College of Medicine, P/Bag 360, Blantyre, 3, Malawi.
authors.forename: Macpherson
authors.initials: M
authors.lastname: Mallewa
authors.affiliation: Malawi-Liverpool Wellcome Trust Clinical Research Programme, PO Box 30096, Chichiri, Blantyre, 3, Malawi. M.J.Gladstone@liverpool.ac.uk.|Clinical Sciences Division, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, UK. M.J.Gladstone@liverpool.ac.uk.|Department of Women and Children's Health, Institute of Translational Medicine, University of Liverpool, Alder Hey NHS Children's Foundation Trust, Eaton Road, Liverpool, L12 2AP, UK. M.J.Gladstone@liverpool.ac.uk.
authors.forename: Melissa
authors.identifier: 0000-0002-2579-9301
authors.initials: M
authors.lastname: Gladstone
mesh_terms: D000203:Activities of Daily Living; D000293:Adolescent; D017028:Caregivers; D002648:Child; D002675:Child, Preschool; D002658:Developmental Disabilities / Q000175:diagnosis / Q000209:etiology*; D005260:Female; D006282:Health Personnel; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D016779:Malaria, Cerebral / Q000175:diagnosis* / Q000401:mortality / Q000503:physiopathology / Q000523:psychology; D016778:Malaria, Falciparum / Q000175:diagnosis* / Q000401:mortality / Q000503:physiopathology / Q000523:psychology; D008295:Malawi; D008297:Male; D017063:Outcome Assessment, Health Care; D010290:Parents; D011379:Prognosis; D036301:Qualitative Research
keywords: Africa; Cerebral malaria; Child disability; Clinical outcomes; Core outcomes; Family perspectives; Interviews; Neurodevelopment; Neurodisability; Qualitative