Williams A E, Rome K, Nester C J
Centre for Rehabilitation and Human Performance Research, University of Salford, Frederick Road, Salford, M6 6PU.
Rheumatology (Oxford). 2007 Feb;46(2):302-7. doi: 10.1093/rheumatology/kel234. Epub 2006 Jul 28.
The structural and functional changes in the RA foot often affect the patient's gait and mobility, impacting on the patient's quality of life. Successful management of these foot pathologies and resultant problems can involve the provision of specialist therapeutic footwear. The aim of the study was to evaluate the value of a new footwear design based on patients' opinions compared with a traditional footwear design.
A total of 80 patients with RA of 5 yrs or more duration, foot deformity, difficulty in being able to obtain suitable retail footwear and self-reported foot pain were recruited. Patients were randomly assigned to either an intervention group (new design) or the control group (traditional design). Patients completed two specific health-related quality of life scales (Foot Health Status Questionnaire and the Foot Function Index) at baseline and after 12 weeks.
Only 36 patients completed the trial. Ten refused the footwear outright and 34 withdrew from the study after the footwear was supplied, due to either non-footwear related problems or reasons related to the footwear. Both the specific health-related quality of life scales demonstrated significant improvement from baseline to week 12 with the intervention group (P < 0.05). There was no significant difference in both specific health-related quality of life scales after week 12 with the traditional group (P > 0.05).
Improvement in pain and patient satisfaction with the new design of footwear for patients with RA over the traditional design indicates the importance of patient involvement in the design process and throughout the process of supplying and monitoring the footwear. The fact that the new-design shoe was based on patients' involvement in the design process in a previous study may be the most important factor in its success. In order to meet the clinical goals of this footwear the patients need to wear them, and to achieve this the patients' requirements need to be acknowledged.
类风湿关节炎（RA）患者足部的结构和功能变化常影响其步态及活动能力，进而影响患者生活质量。成功管理这些足部病变及由此产生的问题可能需要提供专业治疗性鞋具。本研究旨在对比基于患者意见的新型鞋具设计与传统鞋具设计的价值。
共招募80例病程达5年及以上、有足部畸形、难以买到合适的零售鞋且自述有足部疼痛的RA患者。患者被随机分为干预组（新型设计）和对照组（传统设计）。患者在基线期及12周后完成两份特定的与健康相关的生活质量量表（足部健康状况问卷和足部功能指数）。
仅36例患者完成试验。10例直接拒绝使用该鞋具，34例在鞋具提供后退出研究，原因要么是与鞋具无关的问题，要么是与鞋具有关的原因。干预组的两份与健康相关的特定生活质量量表从基线期到第12周均显示出显著改善（P<0.05）。传统组在第12周后，两份与健康相关的特定生活质量量表均无显著差异（P>0.05）。
与传统设计相比，RA患者对新型鞋具设计的疼痛改善及满意度表明患者参与设计过程以及在鞋具供应和监测全过程中的重要性。新设计的鞋具基于患者在先前研究中参与设计过程这一事实可能是其成功的最重要因素。为实现该鞋具的临床目标，患者需要穿着它，而要做到这一点，就需要认可患者的需求。
