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各种招募策略对一项涉及髋或膝骨关节炎患者的随机对照试验的研究人群及结果的影响。

Influence of various recruitment strategies on the study population and outcome of a randomized controlled trial involving patients with osteoarthritis of the hip or knee.

作者信息

Veenhof Cindy, Dekker Joost, Bijlsma Johannes W J, van den Ende Cornelia H M

机构信息

Netherlands Institute for Health Services Research, Utrecht, The Netherlands.

出版信息

Arthritis Rheum. 2005 Jun 15;53(3):375-82. doi: 10.1002/art.21171.

Abstract

OBJECTIVE

To examine the effect of 2 different recruitment methods on the characteristics of participants with osteoarthritis (OA) of the hip or knee and on the efficacy of an exercise program.

METHODS

In a clinical trial on the effectiveness of exercise therapy in OA of the hip or knee, 2 groups of patients were recruited: one group through referrals by physiotherapists (PT group, n = 110) and one group invited by newspaper articles (NP group, n = 90). At baseline, demographic, clinical, and psychosocial data were collected and compared between the 2 groups using chi-square and Student's t-tests. After 13 weeks of exercise therapy and followup assessments at weeks 39 and 65, the main outcome measures (pain, physical function, and global perceived effect) were assessed and compared by multiple regression analysis.

RESULTS

The NP group reported less pain and tiredness at baseline, although more joints were affected with osteoarthritis. The PT group scored higher on the scale 'powerful-others' of locus of control. After adjusting for baseline differences, the effect of treatment after 13, 39, and 65 weeks was comparable for both groups for all outcome measures.

CONCLUSION

Recruitment method affects clinical characteristics and physical functioning of patients recruited for the study. A mix of recruitment strategies does not seem to affect treatment outcome, on the condition that adjustments are made for baseline differences.

摘要

目的

探讨两种不同招募方法对髋或膝骨关节炎(OA)患者特征及运动项目疗效的影响。

方法

在一项关于运动疗法对髋或膝OA有效性的临床试验中,招募了两组患者:一组通过物理治疗师转诊(PT组,n = 110),另一组通过报纸文章邀请(NP组,n = 90)。在基线时,收集人口统计学、临床和社会心理数据,并使用卡方检验和学生t检验在两组之间进行比较。在进行13周运动疗法以及第39周和第65周的随访评估后,通过多元回归分析评估并比较主要结局指标(疼痛、身体功能和整体感知效果)。

结果

NP组在基线时报告的疼痛和疲劳较少,尽管患骨关节炎的关节更多。PT组在“有势力的他人”控制点量表上得分更高。在调整基线差异后,两组在第13、39和65周时所有结局指标的治疗效果相当。

结论

招募方法会影响为本研究招募的患者的临床特征和身体功能。在对基线差异进行调整的情况下,多种招募策略的组合似乎不会影响治疗结果。

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