如何诠释带有主观指标的外科试验避免偏倚行为
Interpreting Surgical Trials With Subjective Outcomes Avoiding UnSPORTsmanlike Conduct
摘要
在JAMA杂志中，有两篇文献报道了“脊柱患者疗效试验（Spine Patient Outcomes Research Trial，SPORT）结果。其中一篇是有关持续性椎间盘相关疼痛和神经症状患者随机接受椎间盘切除术或非手术常规治疗（通常包括单独进行或联合进行患者教育、抗炎药治疗和物理治疗）的多中心试验。研究人员考虑到许多患者会因上述两种治疗方式的风险不同而拒绝接受随机治疗，因此引入了平行对照观察法，以便对符合随机试验但拒绝接受随机治疗的患者加以研究。参加随机试验与观察性队列研究的患者几乎所有特征均相似，随访2年。
出处
《美国医学会杂志（中文版）》
2007年第6期358-359,共2页
The Journal of the American Medical Association(Chinese Edition)
参考文献10
-
1Weinstein JN, Tosteson TD, Lurie JD, et al. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT) : a randomized trial..lAMA. 2006,296:2441-2450.
-
2Weinstein JN, Lurie JD, Tosteson TD, et al. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT) observational cohort. JAMA. 2006,296 : 2451-2459.
-
3Flum DR. The asymptomatic hernia: “if it's not broken, don't fix it.” JAMA. 2006,295:328-329.
-
4Cobb LA, Thomas GI, Dillard DH, Merendino KA, Bruce RA. An evaluation of internal-mammary-artery ligation by a double-blind technic. N Engl J Med. 1959 ,260:1115-1118.
-
5Moseley JB, O'Malley K, Petersen N J, et al. A controlled trial of arthroseopie surgery for osteoarthritis of the knee. N Engl J Med. 2002,347 : 81-88.
-
6Bradley JD, Heilman DK, Katz BP, Gsell P, Wallick JE, Brandt KD. Tidal irrigation as treatment for knee osteoarthritis: a sham-controlled, randomized, double-blinded evaluation Arthritis Rheum. 2002,46:100-108.
-
7McRae C, Cherin E, Yamazaki TG, et al. Effects of perceived treatment on quality of life and medical outcomes in a double-blind placebo surgery trial. Arch Gen Psychiatry. 2004,61:412-420.
-
8Callesen T, Bech K, Thorup J, et ai. Cryoanalgesia: effect on post- herniorrhaphy pain. Anesth Analg. 1998,87:896-899.
-
9Horng S, Miller FG. Ethical framework for the use of sham procedures in clinical trials. Crit Care Med. 2003 ,31 (3 suppl) :S126-S130.
-
10Basse L, Jakobsen DH, Bardram L, et al. Functional recovery after open versus laparoscopic colonic resection: a randomized, blinded study. Ann Surg. 2005 ,241:416-423.
-
1王荣芝,韩金霞.曲唑酮合并氟西汀治疗单相抑郁症疗效观察[J].滨州医学院学报,2001,24(6):590-591. 被引量：4
-
2刘锦峰,潘邑水,张小丽,蒋岚,王会兵,赵振强.降纤酶治疗急性脑梗死疗效观察[J].蛇志,2000,12(2):19-20.
-
3李文碧,汤正才,卫丽,熊晓峰,张英.蝮蛇抗栓酶治疗脑血栓94例[J].蛇志,2000,12(1):50-51.
-
4孙顺成,杨菊,崔建华.精纯抗栓酶治疗急性脑梗死的临床观察[J].蛇志,2000,12(2):14-15.
-
5李志伟,杨才明,马正芳,周开秀,赵纯雁,杨永红,唐玲.降纤酶治疗急性脑梗死的临床观察[J].蛇志,2000,12(3):27-29.
-
6朱新臣,石军锋.降纤酶治疗短暂性脑缺血发作30例疗效观察[J].蛇志,2000,12(3):29-30.
-
7孙志国,牟秀花.降纤酶超早期治疗急性脑梗死的疗效观察[J].蛇志,2000,12(2):41-41.
-
8孙继洲,樊萍,段晓屹,于宗明,姜宏,荣军红.降纤酶治疗急性脑梗死的临床观察[J].蛇志,2000,12(2):31-32.
-
9李建平,陈彬,周法光,乐兴丁,杨文华,洪瑞阳,林艺蝉,魏明月.蕲蛇酶配以高压氧治疗急性脑梗死疗效分析[J].蛇志,2000,12(2):48-49. 被引量：2
-
10胡标伦.蝮蛇抗栓酶治疗脑血栓形成的临床观察[J].蛇志,2000,12(2):10-10. 被引量：2
