ORCHID (Outcome Registry for CHIldren with severe congenital heart Disease) a Swiss, nationwide, prospective, population-based, neurodevelopmental paediatric patient registry: framework, regulations and implementation

Abstract

INTRODUCTION: Congenital heart disease (CHD) is the most frequent birth defect. As survival has significantly improved, attention has turned to neurodevelopmental outcomes of children undergoing heart surgery in early infancy. Since multiple risk factors contribute to neurodevelopmental alterations, a nationwide registry collecting data on medical characteristics, interventions, clinical course and neurodevelopment until school-age is needed to improve the quality of management, identify risk- and protective factors affecting neurodevelopment, and facilitate multicentre trials. METHODS AND ANALYSIS: The Swiss Outcome Registry for CHIldren with severe congenital heart Disease (ORCHID) is a nationwide, prospective, population-based patient registry developed (1) to collect baseline characteristics and clinical data of CHD patients operated with bypass-surgery or hybrid procedures in the first 6 weeks of life in Switzerland, (2) to monitor long-term neurodevelopment, and (3) to relate clinical characteristics and neurodevelopment to identify risk and protective factors in these children. This registry started data collection relating to pregnancy, birth, preoperative course, catheter-based and surgical treatment, postoperative course and reinterventions in 2019. The primary outcome includes standardised neurodevelopmental assessments at 9 to 12 months, 18 to 24 months and 5.5 to 6 years. We expect to include 80 to 100 children per year. Correlation and regression analyses will be used to investigate risk- and protective factors influencing neurodevelopment. ETHICS AND DISSEMINATION OF RESULTS: Swiss ORCHID received support by the Accentus Charitable Foundation, the Anna Mueller Grocholoski Stiftung, the Swiss Society of Paediatric Cardiology, the Verein Kinderherzforschung, and the Corelina – Stiftung für das Kinderherz, and was approved by the cantonal ethics committees. Findings will be presented at national and international scientific meetings, and published in peer-reviewed journals. Results will also be shared with patient organizations, primary health care providers, and public health stakeholders to ensure a widespread dissemination of the results.

Favourable Short- to Mid-Term Outcome after PDA-Stenting in Duct-Dependent Pulmonary Circulation

“…Regarding neurological outcomes, most of our patients showed a normal to mildly impaired neurodevelopmental cognitive outcome, and severe neurodevelopmental impairment was an exception. Our findings regarding neurological outcomes are comparable with the results of other research groups as well as the results of our own research group "Heart and Brain" [38,39].…”

Implementing neurodevelopmental follow‐up care for children with congenital heart disease: A scoping review with evidence mapping

“…Full‐text screening of these 193 publications resulted in 35 publications being included in this review. 9 , 13 , 14 , 15 , 16 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 The stages of the search and screening process and reasons for exclusion are presented in the PRISMA‐ScR flow diagram (Figure S1 ).…”

“…The 35 publications included in the scoping review comprised 33 different studies. Of these, 21 studies examined the implementation of specific programmes or care pathways for neurodevelopmental follow‐up care, 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 42 , 44 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 56 and 12 studies reported on surveys or overviews of current clinical practices in neurodevelopmental follow‐up. 9 , 13 , 14 , 15 , 16 , 30 , 37 , 41 , 43 , 45 , 46 , 55 …”

“…For example, the included publications capture individual care pathways or programmes at only 10 of the 47 institutional members of the Cardiac Neurodevelopmental Outcome Collaborative, the key multicentre and multinational group operating in this field. Additionally, the practice surveys/overviews highlight key programmes in Europe, 16 , 30 Canada, 15 and South Africa, 14 yet only five studies from these regions reported care pathways eligible for inclusion in this review. Consequently, there probably remains opportunity to enhance care internationally through further research publication and formal and informal clinical networks and communities of practice.…”

“…Of these, 21 studies examined the implementation of specific programmes or care pathways for neurodevelopmental follow-up care, [27][28][29][31][32][33][34][35][36][38][39][40]42,44,[47][48][49][50][51][52][53][54]56 and 12 studies reported on surveys or overviews of current clinical practices in neurodevelopmental follow-up. 9,[13][14][15][16]30,37,41,43,45,46,55 Implementation and evaluation of follow-up programmes or care pathways All studies were published after 2011, with most (15 out of 21) conducted since 2018. Fourteen of the studies reported on neurodevelopmental care pathways or programmes based in the USA, 27,[32][33][34][35][36][38][39][40]42,44,[46]…”