Marx B E, Marx M
Medizinische Klinik IV mit Poliklinik, Universität Erlangen-Nürnberg, Germany.
Kidney Int. 1997 Mar;51(3):873-9. doi: 10.1038/ki.1997.123.
Results in studies on prognosis and treatment of membranous nephropathy are conflicting. The aim of this investigation was to analyze the methodology of the existing research and to identify sources of these conflicting results. Studies published on prognosis of membranous nephropathy from 1970 to 1995 were identified using a Medline database literature search. The criteria for inclusion in the methodologic analysis were: (1) original article; (2) cohort study or clinical trial with > or = 50 adults; (3) zero time near the diagnostic renal biopsy; and (4) follow-up > or = six months. Ten well-accepted methodologic standards for prognostic research were applied to each study and the compliance was evaluated. Among the 26 studies that met the inclusion criteria, the median number of standards fulfilled was 4 and the highest was 7. The proportion of studies adhering to the individual standards was: (1) adequate diagnostic criteria, 35%; (2) definite end point, 46%; (3) adequate analysis of a surrogate end point, 52%; (4) analysis of baseline severity, 0%; (5) indication of baseline frequency for candidate predictors, 35%; (6) reproducible classification of predictors, 85%; (7) multivariable analysis, 50%; (8) identification of the variables' importance in multivariable analysis, 38%; (9) evaluation of the effect of treatment on predictors, 19%; and (10) adequate analysis of censored patients, 58%. We conclude that basic methodologic principles have frequently been disregarded. The consideration of these standards in future research can improve the interpretability and applicability of results and help reconcile conflict when results are compared among different studies.
关于膜性肾病预后和治疗的研究结果相互矛盾。本调查的目的是分析现有研究的方法，并找出这些相互矛盾结果的根源。通过医学文献数据库检索，确定了1970年至1995年发表的关于膜性肾病预后的研究。纳入方法学分析的标准为：（1）原创文章；（2）队列研究或临床试验，成人≥50例；（3）诊断性肾活检时接近零时间；（4）随访≥6个月。将十条公认的预后研究方法学标准应用于每项研究，并评估其符合情况。在符合纳入标准的26项研究中，达到的标准中位数为4条，最高为7条。遵循各项标准的研究比例分别为：（1）充分的诊断标准，35%；（2）明确的终点，46%；（3）对替代终点的充分分析，52%；（4）基线严重程度分析，0%；（5）候选预测因素基线频率的说明，35%；（6）预测因素的可重复分类，85%；（7）多变量分析，50%；（8）确定多变量分析中变量的重要性，38%；（9）评估治疗对预测因素的影响，19%；（10）对删失患者的充分分析，58%。我们得出结论，基本的方法学原则经常被忽视。在未来的研究中考虑这些标准可以提高结果的可解释性和适用性，并有助于在比较不同研究结果时调和矛盾。
