modified intent-to-treat的意思 什么意思

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IF连续增长的期刊  生物通报道:根据最近发表在Spine杂志的一项8年随访研究表明,对于腰椎间盘突出患者来说,与非手术治疗相比,手术治疗能够长期内明显地改善疼痛、功能和残疾。本研究的第一作者、英国Dartmouth-Hitchcock 医学中心和盖泽尔医学院的Jon D. Lurie博士和同事们表示:“接受腰椎间盘突出手术治疗的患者,与非手术治疗的患者相比,获得了更大的症状改善。研究结果为椎间盘突出手术治疗增加了证据,但也表明,非手术治疗能够为一些患者提供持久的好处。这项研究成果,将在2014年1月份的Spine杂志上刊出。指定治疗的效果没有显著差异研究人员分析了来自脊椎患者临床实效研究试验(Spine Patient Outcomes Research Trial,SPORT)的数据,SPORT是脊柱疾病手术的一个最大的临床试验。在SPORT中,严格符合腰椎间盘突出标准的患者,接受了手术治疗或非手术治疗(例如物理治疗、锻炼和缓解疼痛的药物)。椎间盘突出患者经受背疼、腿疼(坐骨神经痛)和其它作用于脊神经根的压力所引起的其它症状。当前的分析包括8年来在美国13所脊柱诊所接受治疗的1244名患者的随访数据。大约500名患者被随机指定接受手术治疗(称为椎间盘切除术的一个过程)或非手术治疗,而患者被允许可以“交叉”转到其它治疗。对于其余的患者,手术治疗还是非手术治疗,由患者及他们的医生作决定。研究人员比较了两组之间疼痛、身体功能和残疾的标准测量。与先前SPORT的数据一致,被指定接受手术治疗的患者,往往有更好的疗效。然而,由于很多患者实际上并没有接受他们的指定治疗,这个基于“治疗意向”的差异,并没有统计学上的显著性。根据实际治疗,手术治疗疗效更好当比较接受手术治疗和非手术治疗患者的疗效时,出现了显著的差异。在一个100点疼痛量表上,手术治疗组的疼痛评分要低大约11个点。身体功能和残疾的测量值表现出类似的差异。手术治疗,也为一些其它疗效带来了更大的改善,包括坐骨神经痛症状影响、患者满意度和自评改进。虽然手术治疗的平均疗效得分更好,许多非手术治疗的患者也具有明显的改善。8年后,大约三分之一的临床上指定手术治疗的患者,选择不进行手术治疗。SPORT的主要研究者James N. Weinstein博士说,这项研究成果很有意义,也表明,共享决定权在这个过程中起着重要的作用。Weinstein说:“SPORT研究中的每一位患者,都接受了共同决定权,在这期间他们回顾了其治疗选项的风险和收益相关的客观信息。这使他们能够做出明智的选择,符合自己的价值观。这些患者中约有三分之一的人,仍旧对他们的选择感到满意,我认为,这在很大程度上,是因为他们积极参与了最初的决策过程。”腰椎间盘手术,是美国最常用的一种手术,尽管在不同地区的比例差别很大。以往的研究表明,与非手术治疗相比,手术治疗为椎间盘突出患者,带来了更快的疼痛缓解和恢复。然而,我们很难确定手术治疗的真正影响――特别是由于许多患者将非手术治疗和手术治疗交叉。这往往会低估手术治疗的真实疗效。SPORT的长期随访结果表明,被确诊为腰椎间盘突出的患者,“在缓解症状和改善功能方面,手术治疗要优于非手术治疗。”Lurie博士和共同作者指出,最大的疗效出现在术后6个月内,能持续8年的时间。然而,研究人员表示,许多没有接受手术治疗的患者,“随时间推移,也表现出显著的改善”。他们补充说,转到手术治疗的患者,更可能对自己的症状不满意,感觉他们的症状变得更坏,具有恶化的身体功能和残疾。(生物通:王英)
在生物通推荐原文摘要:Surgical Versus Nonoperative Treatment for Lumbar Disc Herniation: Eight-Year Results for the Spine Patient Outcomes Research TrialAbstractStudy Design. Concurrent prospective randomized and observational cohort studies.
Objective. To assess the 8-year outcomes of surgery versus nonoperative care.
Summary of Background Data. Although randomized trials have demonstrated small short-term differences in favor of surgery, long-term outcomes comparing surgical with nonoperative treatment remain controversial.
Methods. Surgical candidates with imaging-confirmed lumbar intervertebral disc herniation meeting Spine Patient Outcomes Research Trial eligibility criteria enrolled into prospective randomized (501 participants) and observational cohorts (743 participants) at 13 spine clinics in 11 US states. Interventions were standard open discectomy versus usual nonoperative care. Main outcome measures were changes from baseline in the SF-36 Bodily Pain and Physical Function scales and the modified Oswestry Disability Index-AAOS/Modems version assessed at 6 weeks, 3 months, and 6 months, and annually thereafter.
Results. Advantages were seen for surgery in intent-to-treat analyses for the randomized cohort for all primary and secondary outcomes ot however, with extensive nonadherence to treatment assignment (49% patients assigned to nonoperative therapy receiving surgery versus 60% of patients assigned to surgery) these observed effects were relatively small and not statistically significant for primary outcomes (bodily pain, physical function, Oswestry Disability Index). Importantly, the overall comparison of secondary outcomes was significantly greater with surgery in the intent-to-treat analysis (sciatica bothersomeness [P & 0.005], satisfaction with symptoms [P & 0.013], and self-rated improvement [P & 0.013]) in long-term follow-up. An as-treated analysis showed significant surgical treatment effects for primary outcome measures (mean change, surgery vs. 95% confidence interval): bodily pain (45.3 vs. 34.4; 10.9; 7.7 to 14); PF (42.2 vs. 31.5; 10.6; 7.7 to 13.5); and Oswestry Disability Index (&# vs. &#; &#; &# to &#).
Conclusion. Carefully selected patients who underwent surgery for a lumbar disc herniation achieved greater improvement than nonoperativ there was little to no degradation of outcomes in either group (operative and nonoperative) from 4 to 8 years.
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联系信箱:在病毒学,免疫学,以及感染HIV-1的志愿者的临床病程中获得的三期疫苗试验的延长评估(R)网聚医学的力量,源自中国医学论坛报
&&请,我要!
在病毒学,免疫学,以及感染HIV-1的志愿者的临床病程中获得的三期疫苗试验的延长评估
&&&&&&&&&在病毒学,免疫学,以及感染HIV-1的志愿者的临床病程中获得的三期疫苗试验的延长评估
&|&|&|&|&|&
Extended Evaluation of the Virologic, Immunologic, and Clinical Course of Volunteers Who Acquired
Infection in a Phase III Vaccine Trial of ALVAC-HIV and AIDSVAX B/E
Supachai Rerks-Ngarm, Robert M. Paris, Supamit Chunsutthiwat, Nakorn Premsri, Chawetsan Namwat, Chureeratana Bowonwatanuwong, Shuying S. Li, Jaranit Kaewkungkal, Rapee Trichavaroj, Nampueng Churikanont
Background.&The Thai Phase III Trial of ALVAC-HIV and AIDSVAX B/E showed an estimated vaccine efficacy (VE) of 31% to prevent acquisition of human immunodeficiency virus (HIV). Here we evaluated the effect of vaccination on disease progression after infection.
Methods.&CD4+ T-cell counts and HIV viral load (VL) were measured serially. The primary analysis evaluated vaccine efficacy (VEP) as the percent reduction (vaccine vs placebo) in cumulative probability of a primary composite endpoint of clinical and CD4+ count components at prespecified time points after infection. Secondary analyses of biomarker-based endpoints were assessed using marginal mean and linear mixed models.
Results.&There were 61 endpoints in the modified intent-to-treat cohort (mITT; n = 114). There was no evidence for efficacy at 30, 42, 54, and 60 months in the mITT and per protocol (n = 90) cohorts. Estimated VEP (mITT) was15.8% (&21.9, 41.8) at 60 months postinfection. There was weak evidence of lower VL and higher CD4+ count at 60 and 66 months in the vaccine group. Lower mucosal VL was observed among vaccine recipients, primarily in semen (P = .04).
Conclusions.&Vaccination did not affect the clinical course of HIV disease after infection. A potential vaccine effect on the genital mucosa warrants further study.
J Infect Dis. ( (8): .
doi: 10.1093/infdis/jis478
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