The Canadian childhood nephrotic syndrome (CHILDNEPH) study: report on mid-study feasibility, recruitment and main measures - PubMed (original) (raw)

Observational Study

The Canadian childhood nephrotic syndrome (CHILDNEPH) study: report on mid-study feasibility, recruitment and main measures

Susan M Samuel et al. BMC Nephrol. 2019.

Abstract

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.

Keywords: Children; Glucocorticoids; Longitudinal study; Nephrotic syndrome; Practice variation.

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Conflict of interest statement

Ethics approval was obtained from the University of Calgary (REB13–0059) in 2013, and subsequently, the study was approved by research ethics boards at all participating sites. Written parental/guardian consent and patient assent as applicable, were obtained prior to initiating study activities. Consent was also obtained from physicians before their participation.

Not applicable.

Competing interests

The authors declare that they have no competing interests with respect to this manuscript.

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Figures

Fig. 1

Fig. 1

Data collection time points during observation

Fig. 2

Fig. 2

Defining an episode, illustrating sample scenarios. An episode is defined as the time from start of full dose glucocorticoid therapy (60 mg/m2 or 2 mg/kg) to cessation of glucocorticoids (a) or re-start of full dose glucocorticoids as in glucocorticoid dependent patients who relapse while tapering glucocorticoids. (b) Note that the glucocorticoid tapering mode may vary between prescribers. Abbreviation: SD – step down

Fig. 3

Fig. 3

Distribution of age at enrollment into the study

Fig. 4

Fig. 4

Seasonal variation in enrollment and all episodes recorded

Fig. 5

Fig. 5

Site specific differences of cumulative dose of glucocorticoid given (a) and the length of treatment (b) at first presentation. Further illustrated are the site-specific differences of cumulative dose of glucocorticoid given (c) and length of treatment (d) at relapse. Data from 2 sites were not shown due to low enrollment at the time of this report. Note: I Sites 1, 3,5,6,7,9,10 used protocol based treatments for nephrotic syndrome while Sites 2, 4, 8 did not. II Number of patients for sites 1–10 in first presentation graphs were 45, 3, 2, 37, 8, 29, 30, 22, 36 and 29 respectively. III Number of patients for sites 1–10 in relapse graphs were 32, 2, 1, 22, 6, 20, 22, 17, 24 and 18 respectively

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