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The Canadian childhood nephrotic syndrome (CHILDNEPH) study: report on mid-study feasibility, recruitment and main
Susan M Samuel1, Allison Dart2, Guido Filler3
1Section of Nephrology, Departments of Pediatrics and Community Health Sciences, Alberta Children's Hospital Research Institute, O'Brien Institute for Public Health, University of Calgary, 2888 Shaganappi Trail NW, Calgary, Alberta, T3B 6A8, Canada. susan.samuel@ahs.ca.
Insights
Practice variations persist in managing childhood nephrotic syndrome. This study tracks patient and physician data to understand and address these differences in treatment for better outcomes.
Area of Science:
- Pediatric Nephrology
- Clinical Practice Variation
- Longitudinal Cohort Studies
Background:
- Childhood nephrotic syndrome management guidelines exist.
- Practice variations continue despite established guidelines.
- Reasons for persistent practice variation require investigation.
Purpose of the Study:
- Assess practice variation in childhood nephrotic syndrome management.
- Describe patient and physician recruitment characteristics.
- Analyze glucocorticoid prescriptions and second-line agent use.
Main Methods:
- Longitudinal cohort study in Canadian pediatric nephrology centers.
- Recruitment of children with new onset nephrotic syndrome and providers.
- Data collection over minimum 36 months, including relapses and treatment details.
Main Results:
- 243 patients enrolled from 12 centers.
- Median 29 patients per center; median age 7.3 years.
- Observed cumulative dose variability in glucocorticoids and treatment duration between centers.
Conclusions:
- Canadian pediatric nephrology community confirms ongoing practice variability.
- Study aims to evaluate the impact of variability on patient outcomes.
- Facilitates clinical trial implementation for nephrotic syndrome.
Background:
To assess reasons for continuing practice variation in the management of childhood nephrotic syndrome despite expert reviews and guidelines, we are conducting a longitudinal cohort study in children with glucocorticoid sensitive nephrotic syndrome. Objectives of this mid-study report are to describe patient and physician recruitment characteristics, glucocorticoid prescriptions, use of second line agents, biopsy practices, and adherence to study protocol.
Methods:
Children with new onset nephrotic syndrome and providers are being recruited from all 12 pediatric nephrology centres across Canada with > 2½ years follow-up. Data collection points of observation are over a minimum 36 months. Details of prescribed glucocorticoids and of all second line agents used during treatment are being collected. All relapses are being recorded with time to urinary remission of proteinuria.
Results:
To date, 243 patients (57.1% male) from 12 centres were included. Median number of patients per centre was 29 (range 2-45), and median age of cohort was 7.3 (IQR 4.2) at enrollment. Forty-eight physicians were recruited, median 5 (range 2-8) per site. Median number of relapses per patient year of follow-up was 2.1 (IQR 4). Cumulative dose variability of glucocorticoids prescribed per episode of proteinuria and length of treatment was observed between participating centres.
Conclusion:
The Canadian pediatric nephrology community established a longitudinal childhood nephrotic syndrome cohort study that confirms ongoing practice variability. The study will help to evaluate its impact on patient outcomes, and facilitate clinical trial implementation in nephrotic syndrome.
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