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首页> 外文期刊>Archives of disease in childhood. Education and practice edition >Use of databases for clinical research
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Use of databases for clinical research

机译：使用数据库进行临床研究

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Most, if not all readers of the journal will be familiar with the gold-standard of healthcare inter-ventional research—high-quality randomised controlled trials (RCTs) that provide unbiased evidence to guide treatment decisions. However, there are many situations where the clinical question requires something other than an RCT. This may include, for instance, research into aetiological factors ('what are the genetic determinants of childhood leukaemia in Africa?') or prognostic ('what are the clinical features that indicate high risk of mortality in children with pneumonia?') indicators. Equally, there may be logistical, financial and ethical reasons why a clinical trial may not be feasible in a particular clinical setting. Let us take, for example, recent suspicions regarding an increased risk of Clostridium difficile diarrhoea in patients receiving proton pump inhibitors (PPIs).It is not entirely clear if the problem is restricted to hospitalised older adults, or whether it might also involve children who are prescribed PPIs. While it would be theoretically possible to conduct a placebo-controlled RCT by randomising some children to PPIs (accompanied by regular stool collection to detect C difficile infection), there are potentially insurmountable hurdles in trying to overcome ethical constraints or in persuading participants to join the trial. Rather than leaving this important question unanswered, would an alternative option be to interrogate the Microbiology database for positiveegative C difficile stool cultures in children and then check against the inpatient electronic prescribing database to determine whether PPIs had been used or not?
机译：该杂志的大多数（如果不是全部）读者将熟悉医疗保健介入研究的金标准-高质量的随机对照试验（RCT），这些试验可提供公正的证据来指导治疗决策。但是，在许多情况下，临床问题需要的不是RCT。例如，这可能包括对病因学因素（“非洲儿童白血病的遗传决定因素是什么？”）或预后因素（“哪些临床特征表明患有肺炎儿童的高死亡风险？”指标）的研究。同样，在特定的临床环境中，临床试验可能不可行，可能出于后勤，财务和伦理方面的原因。例如，让我们以最近关于接受质子泵抑制剂（PPI）的患者中艰难梭菌腹泻风险增加的怀疑为由，该问题是否仅限于住院的老年人，或者是否也可能涉及到是规定的PPI。虽然从理论上讲可以通过将一些儿童随机分配到PPI进行安慰剂对照的RCT（并定期收集粪便以检测艰难梭菌感染），但在克服道德约束或说服参与者加入抗抑郁药方面可能存在无法克服的障碍。试用。除了让这个重要问题没有得到解答之外，替代方法是询问儿童正/负艰难梭菌粪便培养物的微生物学数据库，然后对照住院电子处方数据库检查是否已使用PPI？

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