Samaan M Constantine, Scheinemann Katrin, Burrow Sarah, Dillenburg Rejane F, Barr Ronald D, Wang Kuan-Wen, Valencia Marlie, Thabane Lehana
Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada Division of Pediatric Endocrinology, McMaster Children's Hospital, Hamilton, Ontario, Canada.
Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada Division of Pediatric Hematology/Oncology, McMaster Children's Hospital, Hamilton, Ontario, Canada Department of Paediatric Hematology/Oncology, University Children's Hospital, Münster, Germany.
BMJ Open. 2014 Jun 26;4(6):e005295. doi: 10.1136/bmjopen-2014-005295.
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.
A single paediatric tertiary care centre in Hamilton, Ontario, Canada.
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.
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.
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.
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.
本研究旨在测试加拿大儿童子宫内膜代谢健康决定因素研究（CanDECIDE）招募参与者及开展研究程序的可行性，该研究旨在评估儿童脑肿瘤幸存者内分泌和代谢健康的决定因素。
加拿大安大略省汉密尔顿市的一家儿科三级护理中心。
我们纳入了年龄在5岁及以上的男孩和女孩，他们体重偏瘦（体重指数（BMI）低于同年龄、性别的第85百分位数）或超重/肥胖（BMI高于同年龄、性别的第85百分位数）。我们排除了正在接受类固醇或免疫抑制治疗的儿童、吸烟者以及参与研究前两周内有活动性感染的儿童。
可行性目标包括至少50%的招募率、80%的参与者同意提供生物样本、90%的问卷完成率以及处理至少80%参与者生物样本的能力。
我们联系了210名潜在参与者；在同意参与的112名（53%）中，30名（26.8%）在7个月内完成了研究访视。所有参与者均同意禁食、提供生物样本并完成问卷。97%（29/30）的参与者样本采集成功，100%采集的样本实验室检测程序可行。我们还测试了开展完整研究所需的资源，包括人员、空间、实验室设备和程序，确定这些都是可行的。
CanDECIDE研究招募患者并获得其同意可能是可行的。然而，由于招募率低于预期，我们正在考虑延长招募时间并与其他中心合作以实现招募目标。问卷的完成以及样本处理方案的实施是可行的。
