为基于人群的临床研究招募有特殊医疗需求的公共保险儿童的可行性。
Feasibility of recruiting publicly insured children with special health care needs for a population-based clinical study.
机构信息
Oral Health Sciences, University of Washington, Seattle, WA, USA.
Oral Health Sciences, B509f Health Sciences Building, University of Washington, Seattle, WA, USA.
出版信息
J Public Health Dent. 2018 Sep;78(4):277-281. doi: 10.1111/jphd.12271. Epub 2018 Apr 12.
OBJECTIVE
Assess the feasibility of recruiting children with special health care needs (CSHCN) into a clinical study using Medicaid data.
METHODS
We used the 3M Clinical Risk Grouping software to identify and classify Medicaid-enrolled CSHCN ages 7-17 years in Washington into one of three chronic condition severity groups: episodic, life-long, or malignancy/catastrophic. We compared contact, recruitment, enrollment, and data completion proportions across severity groups using the Pearson chi-square or Fisher's exact test.
RESULTS
Of the 2,666 CSHSN in the Medicaid files, we contacted 922 and recruited 211 CSHCN (22.8 percent). One-hundred-thirteen made their study visit (53.6 percent) and 98 had complete data (86.7 percent). We contacted and recruited significantly larger proportions of CSHCN with malignancies/catastrophic conditions (P < 0.01). Across severity groups, there were no differences in enrollment (P = 0.27), but a smaller proportion of CSHCN with life-long conditions had complete data (P = 0.03).
CONCLUSION
It is feasible to recruit CSHCN from Medicaid files for clinical studies.
目的
评估使用医疗补助数据招募有特殊医疗需求的儿童（CSHCN）参与临床研究的可行性。
方法
我们使用 3M 临床风险分组软件，将华盛顿州年龄在 7-17 岁的 Medicaid 注册 CSHCN 分为三类慢性疾病严重程度组：偶发性、终身性或恶性肿瘤/灾难性。我们使用 Pearson 卡方检验或 Fisher 确切检验比较了严重程度组之间的接触、招募、入组和数据完成比例。
结果
在 Medicaid 档案中的 2666 名 CSHSN 中，我们联系了 922 名并招募了 211 名 CSHCN（22.8%）。有 113 名儿童进行了研究访问（53.6%），有 98 名儿童完成了完整的数据收集（86.7%）。我们联系和招募了患有恶性肿瘤/灾难性疾病的 CSHCN 的比例显著更高（P<0.01）。在不同严重程度组之间，入组率没有差异（P=0.27），但患有终身性疾病的 CSHCN 中完成数据收集的比例较小（P=0.03）。
结论
从医疗补助档案中招募 CSHCN 参与临床研究是可行的。
Zotero 插件