Original Title: Avis: valeur thérapeutique de l'oxygénothérapie hyperbare chez les enfants avec une paralysie cérébrale

Authors' objectives: The Institut national d’excellence en santé et en services sociaux (INESSS) was mandated by the Ministère de la Santé et des Services sociaux (MSSS) to assess the therapeutic value of hyperbaric oxygen (HBO) on children with cerebral palsy for the purpose of supporting a decision with respect to possibly adding this form of therapy to the range of public services.

Authors' results and conclusions: RESULTS: The systematic review of the literature on this topic identified ten studies, which helped assess the therapeutic value of HBO treatment on children with cerebral palsy: two (2) randomized clinical trials (RCT), the methodology of which was found to be of adequate quality (average to high); and eight (8) studies, the methodology of which was found to be of poor quality due to their many limitations: two (2) RCTs, one (1) pre-post comparative study (PPCS), and five (5) pre-post non-comparative studies (PPNCS). Three (3) health technology assessments on HBO treatment on children with cerebral palsy were published, but none of them has reported on its effectiveness. None of the clinical practice guidelines identified recognized cerebral palsy as an indication to the use of HBO treatment. (EFFICACY) Of all seven (7) outcomes of interest identified in the studies, gross motor skills were measured the most. The other outcomes of interest identified are the child’s autonomy to perform tasks of daily living, ability to communicate and the child’s cognitive processes, social skills, quality of sleep, fine motor skills and spasticity (muscle tone). The scientific data available show no difference between HBO and HBA therapy in terms of efficacy in improving gross motor skills and autonomy, and no impact from an increase in the fraction of inspired oxygen (FiO2) on these outcomes of interest. Furthermore, given the limitations of the very few scientific data available, it is not possible to recognize the efficacy of the treatment with regard to the other five outcomes of interest under review. (INNOCUITY) Earaches or eardrum injuries (middle ear barotrauma) are the most common adverse events reported in four (4) studies; these studies have limitations related to how their authors assessed the innocuity and reported the results. Based on the data available, it is therefore not possible to rule on the innocuity of HBO and HBA treatment on children with cerebral palsy. (QUALITY OF LIFE) None of the studies conducted reported data relating to the aspect of quality of life. Consequently, only data collected from consultations with some parents of a child with cerebral palsy and a few rehabilitation professionals brought to light the importance given by parents to perceived improvement, however minimal, in their child’s condition. For many user parents, HBO treatment – especially when used at home (HBA) – is simple to perform and easily integrates into a family life that is complex and intense and requires managing multiple appointments for medical consultation and rehabilitation and providing almost constant support to their child.

Authors' recommendations: The members of the Comité d’excellence clinique (CEC) in health services deliberated on the scientific, contextual and experiential data at hand in order to decide on the therapeutic value of HBO treatment on children with cerebral palsy. The committee members raised concerns regarding the following: the limitations and quality of the studies selected; the magnitude of the effects reported; the manner in which the results analyzed were measured, in particular because of the tools used, the validity of which in many cases remains to be demonstrated; the conditions under which the children were observed, which are not detailed and may have some impact on findings; the child’s natural evolution, which is not taken into consideration; and the ongoing use, on children, of a technology that is not necessarily risk-free. In the light of the scientific, contextual and experiential data gathered and given the lack of evidence of any therapeutic value, the INESSS considers that adding HBO or HBA to the range of public services to treat children with cerebral palsy is not a fair and reasonable option.

Authors' methods: A systematic literature review was conducted to identify evidence-based findings relevant to the evaluation of the efficacy and innocuity of HBO and its impact on the quality of life of children with cerebral palsy and their parents. Meta-analyses were performed on outcomes of interest when the scientific data so permitted. Contextual and experiential data gathered through consultations with experts (clinicians and scientists) and stakeholders (representatives of a group of parents, an association supporting people with cerebral palsy and their relatives, hyperbaric centers and clinics, physical rehabilitation centers) were presented. Information was gathered from parents of children and young adults with cerebral palsy through the conduct of questionnaires and individual interviews with the aim of understanding their perspective and views.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/valeur-therapeutique-de-loxygenotherapie-hyperbare-chez-les-enfants-avec-une-paralysie-cerebrale.html

Year Published: 2020

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/valeur-therapeutique-de-loxygenotherapie-hyperbare-chez-les-enfants-avec-une-paralysie-cerebrale.html

Requestor: Minister of Health

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Canada

Province: Quebec

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: Gouvernement du Québec