Childhood hand, foot and mouth disease sequelae cohort study in Henan, China: cohort profile

Purpose: The childhood hand, foot and mouth disease (HFMD) sequelae cohort study (HNHFMDCS) is an ambispective cohort study of patients with HFMD based in Henan Province, China, consisting of patients treated in a key hospital for the diagnosis and treatment of HFMD in Henan Province. The study aims to investigate the long-term sequelae of HFMD survivors and to provide a comprehensive understanding of the potential harm caused by this infectious disease.

Participants: In the retrospective phase of the cohort study, children diagnosed with HFMD from January 2014 to January 2023 were included, and clinical and demographic information about the patients was collected through a self-developed questionnaire. Patients hospitalised with HFMD since January 2023 were enrolled in the prospective cohort phase of the study, and long-term follow-up will be performed after completion of the baseline investigation (interview and comprehensive physical examination), clinical laboratory examination and biospecimen collection.

Findings to date: For the retrospective analysis of the cohort, a total of 18 705 HFMD cases (11 834 males and 6871 females) were observed between 2014 and 2022, of which 17 202 were mild cases (10 839 males and 6363 females) and 1503 were severe cases (995 males and 508 females). Statistical analysis was performed on the collected clinical examination data, and descriptive statistical methods, including mean value, SD and t-test, were used to compare the intergroup data. All tests were bilateral, and p<0.05 was considered statistically significant. There were significant differences in the hospitalisation duration and clinical examination indicators, such as platelets (PLT), C reactive protein (CRP), aspartate amino transferase (AST), alanine amino transferase (ALT), T lymphocyte subsets (CD3+ and CD3+CD4+) and B lymphocytes (CD19+) between mild and severe patients. The differences in these clinical examination indicators also help to detect changes in the disease in time so as to deeply understand the potential harm and social burden of the disease, and provide strong support for the rehabilitation of patients.

Future plans: Prospective cohort studies are currently underway, primarily enrolling hospitalised patients with HFMD to participate in our study. After the baseline investigation is completed, we will conduct long-term follow-up of the enrolled cases. In the coming year, we expect to obtain preliminary data on the incidence of sequelae in patients with HFMD 1-10 years after discharge, as well as information on the occurrence of sequelae. This dataset will be updated and expanded on an annual basis to support the continuous monitoring of patient health and disease progression. From HNHFMDCS, the study will provide a comprehensive overview of the potential harm caused by this common infectious disease, assess the social burden caused by this disease and make recommendations for the rehabilitation of survivors and prevention of further disability.