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Recruitment feasibility to a cohort study of endocrine and metabolic health among survivors of childhood brain tumours: a report from the Canadian study of Determinants of Endometabolic Health in ChIlDrEn (CanDECIDE)
  1. M Constantine Samaan1,2,
  2. Katrin Scheinemann1,3,4,
  3. Sarah Burrow5,
  4. Rejane F Dillenburg1,6,
  5. Ronald D Barr1,3,
  6. Kuan-Wen Wang1,2,
  7. Marlie Valencia1,2,
  8. Lehana Thabane1,7,8,9,10
  1. 1Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada
  2. 2Division of Pediatric Endocrinology, McMaster Children's Hospital, Hamilton, Ontario, Canada
  3. 3Division of Pediatric Hematology/Oncology, McMaster Children's Hospital, Hamilton, Ontario, Canada
  4. 4Department of Paediatric Hematology/Oncology, University Children's Hospital, Münster, Germany
  5. 5Division of Pediatric Orthopedics, Department of Pediatric Surgery, McMaster University, Hamilton, Ontario, Canada
  6. 6Division of Pediatric Cardiology, McMaster Children's Hospital, Hamilton, Ontario, Canada
  7. 7Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada
  8. 8Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada
  9. 9Centre for Evaluation of Medicines, Hamilton, Ontario, Canada
  10. 10Biostatistics Unit, St Joseph's Healthcare-Hamilton, Hamilton, Ontario, Canada
  1. Correspondence to Dr M Constantine Samaan; samaanc{at}mcmaster.ca

Abstract

Objectives The aim of this study was to test the feasibility of recruitment and performance of study procedures of the Canadian Study of Determinants of Endometabolic Health in ChIlDrEn (CanDECIDE) study, which was designed to assess the determinants of endocrine and metabolic health in survivors of childhood brain tumours.

Setting A single paediatric tertiary care centre in Hamilton, Ontario, Canada.

Participants We included boys and girls, aged 5 years and older, who were lean (body mass index (BMI) below 85th centile for age and gender) or overweight/obese (BMI 85th centile or above for age and gender). We excluded children on steroids or immunosuppressant therapy, smokers and those who had an active infection for the 2 weeks prior to participation.

Outcomes Feasibility targets included recruitment rate of at least 50%, the consenting of 80% of participants to provide biological samples, 90% questionnaire completion rate and the ability to process biological samples from at least 80% of participants.

Results We approached 210 potential participants, and of the 112 (53%) who agreed to participate, 30 (26.8%) completed the study visit over 7 months. All participants agreed to fast, provide biological samples and complete the questionnaires. Sample collection was successful in 97% (29/30) of participants and laboratory procedures were feasible in 100% of collected samples. We also tested resources required for the conduct of the full study including personnel, space, laboratory equipment and procedures and determined that they are all feasible.

Conclusions Recruitment and consenting of patients for the CanDECIDE study may be feasible. However, we are considering prolonging recruitment duration and collaboration with other centres to meet recruitment targets due to lower than expected recruitment rate. Completion of questionnaires and implementation of sample processing protocols are feasible.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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