Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia.
Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia; Department of Endocrinology and Diabetes, Royal Brisbane and Women's Hospital, Brisbane, Australia.
Contemp Clin Trials. 2021 May;104:106347. doi: 10.1016/j.cct.2021.106347. Epub 2021 Mar 6.
The D-Health Trial aims to determine whether monthly high-dose vitamin D supplementation can reduce the mortality rate and prevent cancer. We did not have adequate statistical power for subgroup analyses, so could not justify the high cost of collecting blood samples at baseline. To enable future exploratory analyses stratified by baseline vitamin D status, we developed models to predict baseline serum 25 hydroxy vitamin D [25(OH)D] concentration.
We used data and serum 25(OH)D concentrations from participants who gave a blood sample during the trial for compliance monitoring and were randomised to placebo. Data were partitioned into training (80%) and validation (20%) datasets. Deseasonalised serum 25(OH)D concentrations were dichotomised using cut-points of 50, 60 and 75 nmol/L. We fitted boosted regression tree models, based on 13 predictors, and evaluated model performance using the validation data.
The training and validation datasets had 1788 (10.5% <50 nmol/L, 23.1% <60 nmol, 48.8 <75 nmol/L) and 447 (11.9% <50 nmol/L, 25.7% <60 nmol/L, and 49.2% <75 nmol/L) samples, respectively. Ambient UV radiation and total intake of vitamin D were the strongest predictors of 'low' serum 25(OH)D concentration. The area under the receiver operating characteristic curves were 0.71, 0.70, and 0.66 for cut-points of <50, <60 and <75 nmol/L respectively.
We exploited compliance monitoring data to develop models to predict serum 25(OH)D concentration for D-Health participants at baseline. This approach may prove useful in other trial settings where there is an obstacle to exhaustive data collection.
D-Health 试验旨在确定每月高剂量维生素 D 补充是否可以降低死亡率并预防癌症。我们没有足够的统计能力进行亚组分析,因此无法证明在基线收集血样的高成本是合理的。为了能够对基于基线维生素 D 状态分层的未来探索性分析,我们开发了预测基线血清 25 羟维生素 D [25(OH)D]浓度的模型。
我们使用在试验期间进行了合规性监测并被随机分配至安慰剂组的参与者的血液样本数据和血清 25(OH)D 浓度。数据被分为训练(80%)和验证(20%)数据集。非季节性血清 25(OH)D 浓度使用 50、60 和 75 nmol/L 的切点进行二分法处理。我们基于 13 个预测因子拟合了增强回归树模型,并使用验证数据评估了模型性能。
训练和验证数据集分别有 1788 例(<50 nmol/L 的血清 25(OH)D 浓度占 10.5%,<60 nmol/L 的占 23.1%,<75 nmol/L 的占 48.8%)和 447 例(<50 nmol/L 的占 11.9%,<60 nmol/L 的占 25.7%,<75 nmol/L 的占 49.2%)样本。环境紫外线辐射和维生素 D 总摄入量是“低”血清 25(OH)D 浓度的最强预测因子。截断值为<50、<60 和<75 nmol/L 时,接收者操作特征曲线下面积分别为 0.71、0.70 和 0.66。
我们利用合规监测数据为 D-Health 参与者开发了预测基线血清 25(OH)D 浓度的模型。这种方法在其他存在数据收集障碍的试验环境中可能会证明是有用的。