一项关于头颈部淋巴水肿自我管理的随机试点研究。
A randomized pilot study on self-management in head and neck lymphedema.
作者信息
McLaughlin Tess M, Broadhurst Jane J, Harris Courtenay J, McGarry Sarah, Keesing Sharon L
机构信息
The School of Occupational Therapy, Social Work and Speech Pathology Curtin University Perth Western Australia Australia.
Occupational Therapy Department Sir Charles Gardiner Hospital Perth Western Australia Australia.
出版信息
Laryngoscope Investig Otolaryngol. 2020 Sep 15;5(5):879-889. doi: 10.1002/lio2.455. eCollection 2020 Oct.
BACKGROUND
The purpose of this pilot trial was to determine the feasibility of a self-managed lymphedema randomized control trial to test the effectiveness of a head and neck-specific exercise protocol.
METHODS
Nine participants were randomized to receive usual treatment provided by an Australian metropolitan teaching hospital (n = 4) or usual treatment with an added head and neck exercise regime (n = 5). Feasibility was assessed through ease of recruitment, adherence, and safety. Lymphedema reduction and quality of life (QOL) data were assessed at baseline (0 week) and follow-up (6 weeks).
RESULTS
The study was feasible in terms of safety and participant retention. However, a slow recruitment rate and low adherence may impact future trials. There were no significant differences in lymphedema reduction or QOL between groups.
CONCLUSION
This pilot feasibility study demonstrated that a self-management trial can be implemented, however, modifications will be required due to the slow recruitment and poor adherence rates.
LEVEL OF EVIDENCE
1b: Individualized randomized control trial.
背景
这项试点试验的目的是确定一项自我管理的淋巴水肿随机对照试验的可行性，以测试一项针对头颈部的运动方案的有效性。
方法
9名参与者被随机分为两组，一组接受澳大利亚一家大都市教学医院提供的常规治疗（n = 4），另一组接受常规治疗并增加头颈部运动方案（n = 5）。通过招募的难易程度、依从性和安全性来评估可行性。在基线（0周）和随访（6周）时评估淋巴水肿减轻情况和生活质量（QOL）数据。
结果
该研究在安全性和参与者留存率方面是可行的。然而，招募速度缓慢和依从性低可能会影响未来的试验。两组之间在淋巴水肿减轻或生活质量方面没有显著差异。
结论
这项试点可行性研究表明，可以实施自我管理试验，然而，由于招募缓慢和依从率低，将需要进行修改。
证据水平
1b：个体化随机对照试验。
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