Designing a placebo device: involving service users in clinical trial design.
Designing a placebo device: involving service users in clinical trial design.
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DOI：
10.1111/hex.12043
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发表时间：
2013-12
期刊：
影响因子：
--
通讯作者：
Adams J
中科院分区：
文献类型：
--
作者：
Gooberman-Hill R;Jinks C;Bouças SB;Hislop K;Dziedzic KS;Rhodes C;Burston A;Adams J
服务用户越来越多地参与临床试验的设计以及产品和设备的开发。服务使用者参与安慰剂开发对于临床试验中可信且可接受的安慰剂至关重要，但这种参与尚未有报道。为了加强未来针对拇指基部骨关节炎 (OA) 的手夹板临床试验的设计，服务使用者参与了夹板的选择和安慰剂夹板的设计。本文描述并反思了这一过程。 2011 年召开了两次服务用户论坛。职业治疗 (OT) 从业者与那些因拇指骨关节炎而使用拇指夹板的服务用户进行了接触，询问其参与情况。共有八位服务用户参加了论坛。服务使用者讨论了他们对 OA 和自己的夹板的体验，然后尝试了各种替代夹板。通过这一点，他们确定了夹板的活性特征以及可接受和不可接受的设计特征。服务用户关注可穿戴性以及无论是否固定的支持。福拉讨论了安慰剂组（“手臂”）是否是未来试验中可接受的特征，服务使用者开发了安慰剂夹板的潜在设计。这是第一个让服务用户参与安慰剂设计的项目。服务用户越来越多地参与产品和设备设计，并且处于理想的位置，可以识别使安慰剂可信但缺乏关键活性成分的功能。未来的试验将包括对其可接受性的研究。
Service users are increasingly involved in the design of clinical trials and in product and device development. Service user involvement in placebo development is crucial to a credible and acceptable placebo for clinical trials, but such involvement has not yet been reported. To enhance the design of a future clinical trial of hand splints for thumb‐base osteoarthritis (OA), service users were involved in splint selection and design of a placebo splint. This article describes and reflects on this process. Two fora of service users were convened in 2011. Service users who had been prescribed a thumb splint for thumb‐base OA were approached about involvement by Occupational Therapy (OT) practitioners. A total of eight service users took part in the fora. Service users discussed their experience of OA and their own splints and then tried a variety of alternative splints. Through this they identified the active features of splints alongside acceptable and unacceptable design features. Service users focused on wearability and support with or without immobilization. Fora discussed whether a placebo group (‘arm’) was an acceptable feature of a future trial, and service users developed a potential design for a placebo splint. This is the first project that to involve service users in placebo design. Service users are increasingly involved in product and device design and are ideally placed to identify features to make a placebo credible yet lacking key active ingredients. The future trial will include research into its acceptability.
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