"Me's me and you's you": Exploring patients' perspectives of single patient (n-of-1) trials in the UK.

"Me's me and you's you": Exploring patients' perspectives of single patient (n-of-1) trials in the UK.
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DOI:
10.1186/1745-6215-8-10
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发表时间:
2007-03-19
期刊:
影响因子:
2.5
通讯作者:
Dieppe P
Dieppe P
中科院分区:
医学4区
文献类型:
--
作者:
Brookes ST;Biddle L;Paterson C;Woolhead G;Dieppe P

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与临床实践中常规进行的“治疗试验”相比,n-of-1试验提供了一种方法学上更合理的方法来确定个体患者的最佳治疗。然而,这种方法在英国很少使用。这项初步研究探讨了英国患者对n-of-1试验的可接受性。膝关节骨关节炎患者被招募到他们自己的12周n-of-1试验中,比较两种膝关节支撑物或NSAID与简单镇痛剂。在试验开始和结束时对患者进行访谈,以探索参与原因、对试验设计的理解和参与经验。完成每日日记,以告知未来的治疗。9例患者参与(5种支持物,4种药物)。患者热衷于参与,认为该试验可能会导致个人收益,如改善症状控制和生活质量。然而,药理学比较的招募更加困难,因为这也可能带来风险。所有患者都渴望完成试验,即使遇到困难。完成每日日记为一些患者提供了更深入的了解他们的病情,这使他们能够改善自我管理。n-of-1试验设计被视为一种“逻辑”设计,提供了一种有效的方法,可根据个人需求和偏好做出个性化治疗决定。这项初步研究表明,患者认为n-of-1试验是一种可接受的个体化治疗方法。此外,参与这样的研究还可以获得比干预措施更大的好处。
The n-of-1 trial offers a more methodologically sound approach to determining optimum treatment for an individual patient than "trials of therapy" routinely conducted in clinical practice. However, such methodology is rarely used in the UK. This pilot study explores the acceptability of n-of-1 trials to patients in the UK. Patients with osteoarthritis of the knee were recruited to their own 12-week n-of-1 trial comparing either two knee supports or an NSAID with simple analgesic. Patients were interviewed at the start and completion of their trial to explore reasons for participation, understanding of the trial design and experiences of participation. Daily diaries were completed to inform future treatment. Nine patients participated (5 supports, 4 drugs). Patients were keen to participate, believing that the trial may lead to personal gains such as improved symptom control and quality of life. However, recruitment to the pharmacological comparison was more difficult since this could also entail risk. All patients were eager to complete the trial, even when difficulties were encountered. Completing the daily diary provided some patients with greater insight into their condition, which allowed them to improve their self-management. The n-of-1 trial design was viewed as a 'logical' design offering an efficient method of reaching a personalised treatment decision tailored to suit individual needs and preferences. This pilot study suggests that patients perceive the n-of-1 trial as an acceptable approach to the individualisation of treatment. In addition, further benefits over and above any gained from the interventions can be derived from involvement in such a study.
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