PDF(Pubmed)
Abstract：
BACKGROUND: Randomized clinical trials (RCTs) are the gold standard for assessing treatment effectiveness; however, they have been criticized for generalizability issues such as how well trial participants represent those who receive the treatments in clinical practice. We assessed the representativeness of participants from eight RCTs for chronic spine pain in the U.S., which were used for an individual participant data meta-analysis on the cost-effectiveness of spinal manipulation for spine pain. In these clinical trials, spinal manipulation was performed by chiropractors.
METHODS: We conducted a retrospective secondary analysis of RCT data to compare trial participants\' socio-demographic characteristics, clinical features, and health outcomes to a representative sample of (a) U.S. adults with chronic spine pain and (b) U.S. adults with chronic spine pain receiving chiropractic care, using secondary data from the National Health Interview Survey (NHIS) and Medical Expenditure Panel Survey (MEPS). We assessed differences between trial and U.S. spine populations using independent t-tests for means and z-tests for proportions, accounting for the complex multi-stage survey design of the NHIS and MEPS.
RESULTS: We found the clinical trials had an under-representation of individuals from health disparity populations with lower percentages of racial and ethnic minority groups (Black/African American 7% lower, Hispanic 8% lower), less educated (No high school degree 19% lower, high school degree 11% lower), and unemployed adults (25% lower) with worse health outcomes (physical health scores 2.5 lower and mental health scores 5.3 lower using the SF-12/36) relative to the U.S. population with spine pain. While the odds of chiropractic use in the U.S. are lower for individuals from health disparity populations, the trials also under-represented these populations relative to U.S. adults with chronic spine pain who visit a chiropractor.
CONCLUSIONS: Health disparity populations are not well represented in spine pain clinical trials. Embracing key community-based approaches, which have shown promise for increasing participation of underserved communities, is needed.
METHODS: We conducted a retrospective secondary analysis of RCT data to compare trial participants\' socio-demographic characteristics, clinical features, and health outcomes to a representative sample of (a) U.S. adults with chronic spine pain and (b) U.S. adults with chronic spine pain receiving chiropractic care, using secondary data from the National Health Interview Survey (NHIS) and Medical Expenditure Panel Survey (MEPS). We assessed differences between trial and U.S. spine populations using independent t-tests for means and z-tests for proportions, accounting for the complex multi-stage survey design of the NHIS and MEPS.
RESULTS: We found the clinical trials had an under-representation of individuals from health disparity populations with lower percentages of racial and ethnic minority groups (Black/African American 7% lower, Hispanic 8% lower), less educated (No high school degree 19% lower, high school degree 11% lower), and unemployed adults (25% lower) with worse health outcomes (physical health scores 2.5 lower and mental health scores 5.3 lower using the SF-12/36) relative to the U.S. population with spine pain. While the odds of chiropractic use in the U.S. are lower for individuals from health disparity populations, the trials also under-represented these populations relative to U.S. adults with chronic spine pain who visit a chiropractor.
CONCLUSIONS: Health disparity populations are not well represented in spine pain clinical trials. Embracing key community-based approaches, which have shown promise for increasing participation of underserved communities, is needed.
摘要：
背景：随机临床试验（RCT）是评估治疗有效性的金标准；然而，他们因普遍性问题而受到批评,例如试验参与者在临床实践中代表接受治疗者的程度如何.我们评估了美国八个RCT慢性脊柱疼痛患者的代表性，这些数据用于对脊柱疼痛进行脊柱操作的成本效益的个体参与者数据荟萃分析。在这些临床试验中,脊柱操作由脊医进行。
方法：我们对RCT数据进行了回顾性二次分析，以比较试验参与者的社会人口统计学特征，临床特征,和健康结果的代表性样本（a）美国成年人患有慢性脊柱疼痛和（b）美国成年人患有慢性脊柱疼痛接受脊椎治疗，使用来自国家健康访谈调查(NHIS)和医疗支出小组调查(MEPS)的二级数据。我们使用独立的均值t检验和比例z检验来评估试验和美国脊柱人群之间的差异。考虑到NHIS和MEPS复杂的多阶段调查设计。
结果：我们发现临床试验中，来自健康差异人群的个体代表性不足，种族和少数民族比例较低（黑人/非洲裔美国人低7%，西班牙裔低8%)，受教育程度较低(高中学历不低19%，高中学位低11%)，与患有脊柱疼痛的美国人群相比，健康结果较差（使用SF-12/36，身体健康评分低2.5，心理健康评分低5.3）的失业成年人（低25％）。虽然在美国，来自健康差异人群的个体使用脊椎按摩疗法的几率较低，相对于就诊于脊医的患有慢性脊柱疼痛的美国成年人,这些试验的代表性也不足.
结论：脊柱疼痛临床试验中没有很好地代表健康差异人群。采用基于社区的关键方法，这表明有希望增加服务不足的社区的参与，是需要的。
方法：我们对RCT数据进行了回顾性二次分析，以比较试验参与者的社会人口统计学特征，临床特征,和健康结果的代表性样本（a）美国成年人患有慢性脊柱疼痛和（b）美国成年人患有慢性脊柱疼痛接受脊椎治疗，使用来自国家健康访谈调查(NHIS)和医疗支出小组调查(MEPS)的二级数据。我们使用独立的均值t检验和比例z检验来评估试验和美国脊柱人群之间的差异。考虑到NHIS和MEPS复杂的多阶段调查设计。
结果：我们发现临床试验中，来自健康差异人群的个体代表性不足，种族和少数民族比例较低（黑人/非洲裔美国人低7%，西班牙裔低8%)，受教育程度较低(高中学历不低19%，高中学位低11%)，与患有脊柱疼痛的美国人群相比，健康结果较差（使用SF-12/36，身体健康评分低2.5，心理健康评分低5.3）的失业成年人（低25％）。虽然在美国，来自健康差异人群的个体使用脊椎按摩疗法的几率较低，相对于就诊于脊医的患有慢性脊柱疼痛的美国成年人,这些试验的代表性也不足.
结论：脊柱疼痛临床试验中没有很好地代表健康差异人群。采用基于社区的关键方法，这表明有希望增加服务不足的社区的参与，是需要的。
