OBJECTIVE: The purpose of this study was to explore these issues and to assess the feasibility of implementing qualitative research methods within a clinical trial.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
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