A composite outcome for mild traumatic brain injury in trials of hyperbaric oxygen

创伤性脑损伤 高压氧 析因分析 随机对照试验 医学 临床试验 物理疗法 事后 心理学 内科学 麻醉 精神科
作者
Lindell K. Weaver,Susan Churchill,Steffanie H Wilson,Donald Hebert,Kayla Deru,Anne S. Lindblad
出处
期刊:Undersea & Hyperbaric Medicine [Undersea and Hyperbaric Medical Society (UHMS)]
卷期号:46 (3): 341-352 被引量:7
标识
DOI:10.22462/13.15.2019.11
摘要

Global outcomes can strengthen inferences from clinical trials. We evaluate global outcomes for persistent post-concussive symptoms (PCS) after mild traumatic brain injury (mTBI) in two clinical trials of hyperbaric oxygen (HBO2) in United States service members.During study design, outcomes of symptom, cognitive, and functional impairments planned for a trial of HBO2 for PCS (HOPPS) were weighted and grouped into different domains to formulate the composite outcome total score. The composite outcome was compared between the intervention groups in HOPPS and those in a subsequent HBO2 trial (BIMA) for validation. Additionally, two post hoc global outcome measures were explored, including one composed of components that demonstrated favorable characteristics in both studies and another via components used in another TBI randomized trial (COBRIT).In total, 143 active-duty or veteran military personnel were randomized across the two studies. Composite total scores improved from baseline for HBO2 (mean ± SD -2.9±9.0) and sham (-2.9±6.6) groups in HOPPS but did not differ significantly between groups (p=0.33). In BIMA, 13-week changes from baseline favored the HBO2 group (-3.6±6.4) versus sham (-0.3±5.2; p=0.02). No between-group differences were found when COBRIT composite scoring was applied to BIMA. Overall, HBO2 effects were maximized when the post hoc global measure derived from both studies was applied to the data.Composite total scores in HOPPS and BIMA were consistent with primary study results. The global measures considered may offer utility as endpoints to achieve maximal HBO2 effect in future trials of the mTBI population.clinicaltrials.gov Identifiers NCT01611194 (BIMA) and NCT01306968 (HOPPS).

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
g7001完成签到,获得积分10
2秒前
blue发布了新的文献求助10
2秒前
刘铭晨完成签到,获得积分10
2秒前
XYZ完成签到 ,获得积分10
3秒前
wmszhd完成签到,获得积分10
3秒前
付艳完成签到,获得积分10
3秒前
CAOHOU应助论文顺利采纳,获得10
4秒前
nancy93228完成签到 ,获得积分10
5秒前
搜集达人应助JW采纳,获得10
7秒前
???完成签到,获得积分10
9秒前
优秀的白曼完成签到,获得积分10
11秒前
王小西发布了新的文献求助10
12秒前
碧蓝莫言完成签到 ,获得积分10
14秒前
清璃完成签到 ,获得积分10
15秒前
虚心的寒梦完成签到,获得积分10
15秒前
秋秋发布了新的文献求助10
15秒前
kkk完成签到,获得积分10
17秒前
bnhh完成签到,获得积分10
17秒前
Betty应助lindahuang采纳,获得10
18秒前
ilk666完成签到,获得积分10
19秒前
小王同学发布了新的文献求助10
19秒前
奶油布丁完成签到,获得积分10
22秒前
酶没美镁完成签到,获得积分10
22秒前
天天快乐应助李治海采纳,获得10
23秒前
星辰大海应助lll采纳,获得10
23秒前
龙1完成签到,获得积分10
23秒前
yzhilson完成签到 ,获得积分10
24秒前
量子星尘发布了新的文献求助10
25秒前
RRR完成签到,获得积分10
26秒前
金色天际线完成签到,获得积分10
27秒前
明ming到此一游完成签到 ,获得积分10
30秒前
pophoo完成签到,获得积分10
30秒前
11发布了新的文献求助10
31秒前
酷炫的黄豆完成签到 ,获得积分10
32秒前
hzz完成签到,获得积分10
35秒前
36秒前
深情安青应助科研通管家采纳,获得10
36秒前
fang应助科研通管家采纳,获得10
36秒前
Passskd发布了新的文献求助10
36秒前
fang应助科研通管家采纳,获得10
36秒前
高分求助中
【提示信息,请勿应助】关于scihub 10000
Les Mantodea de Guyane: Insecta, Polyneoptera [The Mantids of French Guiana] 3000
徐淮辽南地区新元古代叠层石及生物地层 3000
The Mother of All Tableaux: Order, Equivalence, and Geometry in the Large-scale Structure of Optimality Theory 3000
Handbook of Industrial Diamonds.Vol2 1100
Global Eyelash Assessment scale (GEA) 1000
Picture Books with Same-sex Parented Families: Unintentional Censorship 550
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 4038303
求助须知:如何正确求助?哪些是违规求助? 3576013
关于积分的说明 11374210
捐赠科研通 3305780
什么是DOI,文献DOI怎么找? 1819322
邀请新用户注册赠送积分活动 892672
科研通“疑难数据库(出版商)”最低求助积分说明 815029