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临床研究中的真相留存:一曲基于证据的安魂曲?

Truth survival in clinical research: an evidence-based requiem?

作者信息

Poynard Thierry, Munteanu Mona, Ratziu Vlad, Benhamou Yves, Di Martino Vincent, Taieb Julien, Opolon Pierre

机构信息

Service d'Hépato-Gastroentérologie, Groupe Hospitalier Pitié-Salpêtrière, 47-83 Boulevard de l'Hôpital, 75651 Paris Cedex 13, France.

出版信息

Ann Intern Med. 2002 Jun 18;136(12):888-95. doi: 10.7326/0003-4819-136-12-200206180-00010.

Abstract

PURPOSE

Factors associated with the survival of truth of clinical conclusions in the medical literature are unknown. The authors hypothesized that conclusions derived from studies using better methodology should have a longer half-life.

DATA SOURCES

MEDLINE and hand searches of journals with studies on cirrhosis and hepatitis.

STUDY SELECTION

Original articles and meta-analyses published from 1945 to 1999 about cirrhosis or hepatitis in adults.

DATA SYNTHESIS

In 2000, 285 of 474 conclusions (60%) were still considered to be true, 91 (19%) were considered to be obsolete, and 98 (21%) were considered to be false. The half-life of truth was 45 years. The 20-year survival of conclusions derived from meta-analysis was lower (57% +/- 10%) than that from nonrandomized studies (87% +/- 2%) (P < 0.001) or randomized trials (85% +/- 3%) (P < 0.001). The survival of conclusions was not different when studies of high methodologic quality were compared with those of low quality. In randomized trials, the 50-year survival rate was higher for 52 negative conclusions (68% +/- 13%) than for 118 positive conclusions (14% +/- 4%) (P < 0.001).

CONCLUSIONS

Contrary to the authors' hypothesis, conclusions based on recognized, good methodology had no clear survival advantage. To better convince clinicians of the long-term utility of evidence-based medicine, better prognostic factors should be developed.

摘要

目的

医学文献中临床结论真实性的存活相关因素尚不清楚。作者推测,采用更好方法学的研究得出的结论应具有更长的半衰期。

数据来源

MEDLINE以及对手册中有关肝硬化和肝炎研究的期刊进行检索。

研究选择

1945年至1999年发表的关于成人肝硬化或肝炎的原创文章和荟萃分析。

数据综合

2000年,474条结论中有285条(60%)仍被认为是正确的,91条(19%)被认为过时,98条(21%)被认为错误。真实性的半衰期为45年。荟萃分析得出的结论的20年生存率(57%±10%)低于非随机研究(87%±2%)(P<0.001)或随机试验(85%±3%)(P<0.001)。将高质量研究与低质量研究的结论生存率进行比较时,并无差异。在随机试验中,52条阴性结论的50年生存率(68%±13%)高于118条阳性结论(14%±4%)(P<0.001)。

结论

与作者的假设相反,基于公认的良好方法学得出的结论没有明显的存活优势。为了更好地使临床医生相信循证医学的长期效用,应制定更好的预后因素。

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