Hadley Gina, Derry Sheena, Moore R Andrew, Wee Bee
Pain Research Unit, Nuffield Department of Anaesthetics, University of Oxford, John Radcliffe Hospital, Headington, Oxford, UK.
J Pain Palliat Care Pharmacother. 2009;23(2):106-13. doi: 10.1080/15360280902899921.
Evidence-based medicine demands 'gold standard' randomized controlled trials (RCTs). If strict criteria of quality, validity, and size are met, observational studies give the same result. Given the dearth of RCTs in palliative care, our aim was to identify good observational studies using PubMed searches and e-mail letters to experts in palliative care. The prior intention was provide the most comprehensive description possible to date of observational studies in palliative care, rather than to perform any statistical analyses. Three hundred and forty abstracts of study reports were identified, of which 27% (91) included > or = 200 subjects and 8% (27) > or = 1000 subjects. In reports with > or = 200 subjects, 51% included only cancer patients, and 42% included heterogeneous 'palliative care' patients. Prospective and retrospective studies accounted for 38% and 32% of all reports with > or = 200 subjects. In reports with > or = 1000 subjects, 59% were retrospective and 19% prospective. Patients had some input in 26% of studies with > or = 200 subjects, and 15% with > or = 1000 subjects. Only 12 prospective reports had one specific intervention. We found that palliative care is deficient not only in RCTs, but also good quality observational studies. Those that exist are extremely heterogeneous in subject, design, outcome reporting, and intervention.
循证医学要求采用“金标准”随机对照试验（RCT）。如果满足严格的质量、有效性和规模标准，观察性研究也能得出相同的结果。鉴于姑息治疗领域随机对照试验的匮乏，我们的目标是通过在PubMed上检索以及给姑息治疗专家发送电子邮件的方式，找出高质量的观察性研究。之前的意图是尽可能全面地描述迄今为止姑息治疗领域的观察性研究，而非进行任何统计分析。共识别出340篇研究报告的摘要，其中27%（91篇）纳入了≥200名受试者，8%（27篇）纳入了≥1000名受试者。在纳入≥200名受试者的报告中，51%仅纳入了癌症患者，42%纳入了异质性的“姑息治疗”患者。前瞻性和回顾性研究在所有纳入≥200名受试者的报告中分别占38%和32%。在纳入≥1000名受试者的报告中，59%为回顾性研究，19%为前瞻性研究。在纳入≥200名受试者的研究中，26%的研究让患者有一定参与度；在纳入≥1000名受试者的研究中，这一比例为15%。只有12篇前瞻性报告有一项特定干预措施。我们发现，姑息治疗不仅缺乏随机对照试验，也缺乏高质量的观察性研究。现有的观察性研究在研究对象、设计、结果报告和干预措施方面极其异质性。
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