Department of Primary Care and Public Health, School of Medicine, Cardiff University, Cardiff, UK.
Br J Gen Pract. 2011 Aug;61(589):e452-8. doi: 10.3399/bjgp11X588411.
The Hip & Knee Book: Helping you cope with osteoarthritis was developed to change disadvantageous beliefs and encourage physical activity in people with hip or knee osteoarthritis.
To assess the feasibility of conducting a definitive randomised controlled trial (RCT) of this evidence-based booklet in people with hip or knee osteoarthritis.
Phase II feasibility randomised controlled trial (RCT).
Computerised searches of patients' record databases identified people with osteoarthritis of the hip or knee, who were invited to participate in the RCT comparing the new booklet with a control booklet. Outcomes were measured at baseline, 1 month, and 3 months, and included: beliefs about hip and knee pain, exercise, and fear avoidance; level of physical activity; and health service use.
The trial methods were feasible in terms of recruitment, randomisation, and follow-up, but most participants recruited had longstanding established symptoms. After one and 3 months, there was a small relative improvement in illness, exercise, and fear-avoidance beliefs and physical activity level in The Hip & Knee Book group (n = 59) compared with the control group (n = 60), which provides some proof of principle for using these outcomes in future trials.
This feasibility study provided proof of principle for testing The Hip & Knee Book in a larger definitive RCT.
《髋关节和膝关节手册：帮助您应对骨关节炎》一书的编写旨在改变人们对于骨关节炎的不利观念，鼓励髋关节或膝关节骨关节炎患者进行身体活动。
评估在髋关节或膝关节骨关节炎患者中开展这项基于证据的小册子的确定性随机对照试验（RCT）的可行性。
二期可行性随机对照试验（RCT）。
通过计算机检索患者的病历数据库，找出患有髋关节或膝关节骨关节炎的患者，并邀请他们参加比较新小册子和对照组小册子的 RCT。在基线、1 个月和 3 个月时测量结局，包括：髋关节和膝关节疼痛、运动和恐惧回避的信念；身体活动水平；以及卫生服务的使用。
从招募、随机化和随访的角度来看，试验方法是可行的，但大多数招募的参与者都有长期存在的既定症状。在 1 个月和 3 个月后，与对照组（n = 60）相比，《髋关节和膝关节手册》组（n = 59）的疾病、运动和恐惧回避信念以及身体活动水平都有相对较小的改善，这为将来使用这些结局进行试验提供了一定的原理证明。
这项可行性研究为在更大规模的确定性 RCT 中测试《髋关节和膝关节手册》提供了原理证明。
