Kjaergard Lise L, Als-Nielsen Bodil
Cochrane Hepatobiliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Department 7102, H:S Rigshospitalet, DK-2100 Copenhagen, Denmark.
BMJ. 2002 Aug 3;325(7358):249. doi: 10.1136/bmj.325.7358.249.
To assess the association between competing interests and authors' conclusions in randomised clinical trials.
Epidemiological study of randomised clinical trials published in the BMJ from January 1997 to June 2001. Financial competing interests were defined as funding by for profit organisations and other competing interests as personal, academic, or political.
159 trials from 12 medical specialties.
Authors' conclusions defined as interpretation of extent to which overall results favoured experimental intervention. Conclusions appraised on 6 point scale; higher scores favour experimental intervention.
Authors' conclusions were significantly more positive towards the experimental intervention in trials funded by for profit organisations alone compared with trials without competing interests (mean difference 0.48 (SE 0.13), P=0.014), trials funded by both for profit and non-profit organisations (0.30 (SE 0.10), P=0.003), and trials with other competing interests (0.45 (SE 0.13), P=0.006). Other competing interests and funding from both for profit and non-profit organisations were not significantly associated with authors' conclusions. The association between financial competing interests and authors' conclusions was not explained by methodological quality, statistical power, type of experimental intervention (pharmacological or non-pharmacological), type of control intervention (for example, placebo or active drug), or medical specialty.
Authors' conclusions in randomised clinical trials significantly favoured experimental interventions if financial competing interests were declared. Other competing interests were not significantly associated with authors' conclusions.
评估随机临床试验中利益冲突与作者结论之间的关联。
对1997年1月至2001年6月发表在《英国医学杂志》上的随机临床试验进行的流行病学研究。经济利益冲突定义为由营利性组织提供资金,其他利益冲突定义为个人、学术或政治方面的。
来自12个医学专业的159项试验。
作者结论定义为对总体结果支持试验性干预程度的解读。结论采用6分制评估;分数越高越支持试验性干预。
与无利益冲突的试验相比,仅由营利性组织资助的试验中作者的结论对试验性干预明显更为积极(平均差异0.48(标准误0.13),P = 0.014),由营利性和非营利性组织共同资助的试验(0.30(标准误0.10),P = 0.003),以及存在其他利益冲突的试验(0.45(标准误0.13),P = 0.006)。其他利益冲突以及由营利性和非营利性组织共同提供的资金与作者结论无显著关联。经济利益冲突与作者结论之间的关联无法通过方法学质量、统计效能、试验性干预类型(药理学或非药理学)、对照干预类型(例如,安慰剂或活性药物)或医学专业来解释。
如果声明了经济利益冲突,随机临床试验中作者的结论明显更倾向于试验性干预。其他利益冲突与作者结论无显著关联。