Evans Roni L, Maiers Michele J, Bronfort Gert
Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University, Bloomington, Minn. 55431, USA.
J Manipulative Physiol Ther. 2003 Oct;26(8):502-9. doi: 10.1016/S0161-4754(03)00107-6.
Little is known about the issues low back pain patients take into account when deciding their satisfaction with care, the importance placed on such satisfaction, or the factors they consider when assessing their overall improvement.
The purpose of this study was to explore these issues and to assess the feasibility of implementing qualitative research methods within a clinical trial.
Study participants were volunteers taking part in a randomized clinical pilot study comparing nonsurgical treatments for sciatica. Face-to-face interviews were conducted, transcribed, and analyzed using content analysis.
All 31 individuals who participated in the pilot study were interviewed. When asked which issues they considered when deciding their satisfaction with care, the most frequently identified themes were change in pain, personnel, and the treatment experience. When assessing their overall improvement, all participants considered whether their pain had changed. In response to the question asking participants which outcomes they considered to be most important, severity of pain and quality of life were most commonly cited.
This study demonstrated that a "mixed methods" approach using qualitative research methods within a clinical trial is not only feasible but can provide interesting and useful information for trial interpretation and future study design. By providing insight to the multidimensional nature of patients' beliefs and perceptions, this technique may not only shape but also redefine the focus of patient-oriented research and health care for low back pain conditions.
对于腰痛患者在决定对治疗的满意度时所考虑的问题、对这种满意度的重视程度,或者在评估自身总体改善情况时所考虑的因素,我们了解甚少。
本研究旨在探讨这些问题,并评估在一项临床试验中实施定性研究方法的可行性。
研究参与者是参加一项比较坐骨神经痛非手术治疗的随机临床试验的志愿者。进行面对面访谈,记录访谈内容并采用内容分析法进行分析。
对参加试点研究的所有31人都进行了访谈。当被问及在决定对治疗的满意度时考虑了哪些问题时,最常提及的主题是疼痛的变化、医护人员以及治疗体验。在评估自身总体改善情况时,所有参与者都考虑了疼痛是否有所变化。在回答关于参与者认为哪些结果最重要的问题时,最常提到的是疼痛的严重程度和生活质量。
本研究表明,在临床试验中采用定性研究方法的“混合方法”不仅可行,而且可以为试验解读和未来研究设计提供有趣且有用的信息。通过深入了解患者信念和认知的多维度性质,这种技术不仅可能塑造而且可能重新定义针对腰痛病症的以患者为导向的研究和医疗保健的重点。