Kjaergard Lise Lotte, Gluud Christian
The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Rigshospitalet, Denmark.
Am J Gastroenterol. 2002 Nov;97(11):2708-13. doi: 10.1111/j.1572-0241.2002.07067.x.
The aim of this study was to assess whether funding and the disease area are related to the internal validity of hepatobiliary randomized clinical trials.
We gathered data on funding, disease area, methodological quality (randomization and double blinding), and sample size from 616 hepatobiliary randomized clinical trials published from 1985 to 1996 in 12 MEDLINE indexed journals.
The internal validity (methodological quality and sample size) of trials funded by profit or nonprofit organizations was not significantly different. Compared with these trials, trials without funding were significantly less likely to report adequate generation of the allocation sequence (55% vs 41%, p = 0.001) and to be double blind (42% vs 25%, p < 0.001), but the proportion with adequate allocation concealment and the sample size were not significantly different. The trials covered 12 disease areas. The proportion of funded trials did not differ significantly in different disease areas. The disease area was significantly associated with the proportion of trials with adequate generation of the allocation sequence (p < 0.001), allocation concealment (p = 0.003), and double blinding (p < 0.001) as well as the sample size (p < 0.001). This association was not explained by the proportion of trials with funding.
External funding was significantly associated with adequate methodological quality, but not with the sample size. Irrespective of funding, the disease area was significantly associated with the methodological quality and sample size. Accordingly, external funding and the disease area are significant predictors of the internal validity of hepatobiliary randomized clinical trials.
本研究旨在评估资金来源和疾病领域是否与肝胆随机临床试验的内部效度相关。
我们收集了1985年至1996年发表在12种被MEDLINE索引的期刊上的616项肝胆随机临床试验的资金来源、疾病领域、方法学质量（随机化和双盲）以及样本量的数据。
由盈利或非营利组织资助的试验的内部效度（方法学质量和样本量）无显著差异。与这些试验相比，无资金资助的试验报告适当的分配序列产生的可能性显著更低（55%对41%，p = 0.001），且双盲的可能性也显著更低（42%对25%，p < 0.001），但分配隐藏充分的比例和样本量无显著差异。这些试验涵盖12个疾病领域。不同疾病领域中获得资助的试验比例无显著差异。疾病领域与分配序列产生适当、分配隐藏以及双盲的试验比例以及样本量均显著相关（p < 0.001）。这种关联无法通过有资金资助的试验比例来解释。
外部资金与适当的方法学质量显著相关，但与样本量无关。无论资金来源如何，疾病领域与方法学质量和样本量均显著相关。因此，外部资金和疾病领域是肝胆随机临床试验内部效度的重要预测因素。
