J Manipulative Physiol Ther. 2003 (Oct); 26 (8): 502–509 ~ FULL TEXT
Roni L Evans, DC, Michele J Maiers, DC, Gert Bronfort, DC, PhD
Wolfe-Harris Center for Clinical Studies,
Northwestern Health Sciences University,
Bloomington, Minn. 55431, USA.
BACKGROUND: 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.
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.
Keywords: Satisfaction, Outcome Measures, Low Back Pain, Qualitative Research
From the FULL TEXT Article:
For many years, the treatment approach to low back pain (LBP) has been predicated on the “disease model.”  By focusing on physiological damage, this model took a 1–dimensional approach to resolving LBP symptoms. LBP has proven, however, to be much more complex. As Gordon Waddell,  a leading authority in LBP research contends, the disease model of LBP was “fundamentally flawed” because it failed to allow for complex human responses to pain and disability. Consequently, the biopsychosocial model of LBP has emerged, acknowledging the important interaction of the physical, psychological, and social aspects of this vexing condition 
An important component of the biopsychosocial model is recognizing the importance patients' perspectives and views play in the management of LBP. Consequently, patient satisfaction has emerged as a critical outcome measure in health care services and clinical research.  It is now generally accepted that the most effective treatments for LBP will not only be the most cost-effective with the least side effects but also the most satisfying to patients.  Unfortunately, little is known regarding the issues LBP patients take into account when deciding their satisfaction and the importance they place on such satisfaction. Patient-rated improvement is another commonly used outcome measure that takes into account patients' perceptions of overall change in their LBP condition. [5–7] Similar to satisfaction, we have inadequate insight into the factors patients consider when assessing their overall improvement.
Recognition of the multidimensional nature of LBP and the desire to explore patient perspectives has necessitated a broader research approach than what has traditionally been taken.  One such approach, put forth by Miller et al,  advocates a “new gold standard” of clinical research, the multimethod randomized clinical trial, which they conceptualize as a double stranded helix of DNA. “On one strand are qualitative methods addressing issues of context, meaning, power and complexity, and on the other are quantitative methods providing measurement and a focused anchor. The two strands are connected by research questions. The qualitative and quantitative strands twist and spiral around the questions in an ongoing interaction, creating codes of understanding that get expressed in better clinical care.” 
Our group was interested in applying this approach to assess how patients interpret outcome measures used in clinical trials, specifically satisfaction with care and overall improvement. This article describes the application of qualitative methods within a randomized clinical pilot study.  The primary objective was to explore the issues patients with sciatica (low back–related leg pain) considered when evaluating their satisfaction with treatment and overall improvement. Further, to inform future research and ensure that our results are meaningful and relevant, we asked patients to tell us which outcome measures were most important to them. Finally, the feasibility of implementing a mixed methods approach within a clinical trial was assessed.
In this study, qualitative methods were effectively used to identify the issues participants considered when determining their satisfaction with care and overall improvement, as well as determining which outcome measures were most important to them.
Pain was consistently the main factor that patients took into consideration when determining satisfaction with care and overall change. It was also the outcome measure participants considered the most important to them. This supports what clinicians have long recognized in practice and suggests that patient-rated pain is an appropriate primary outcome measure for randomized clinical trials assessing the effectiveness of various therapies for low back pain conditions.
While pain management is an essential focus for the care of LBP conditions, the participants in this study highlighted the true multidimensional nature of this important health problem. Approximately half of the respondents in this study rated a change in their ability to perform certain activities to be a factor they considered when evaluating their overall improvement, and just over half considered quality of life to be one of the most important outcomes to them. This confirms the importance of outcomes in clinical research that measure how LBP affects patients' abilities to perform daily activities (ie, Roland Morris and Oswestry Disability questionnaires), [14, 18] as well as scales addressing overall quality of life (ie, SF-36 Health Survey and Coastal Ocean Observations Panel [COOP] questionnaires). [18–21] Importantly, these instruments also can be useful to practitioners in health care practice for assessing and monitoring individual patient treatment programs.
Personnel factors were also important issues that patients took into account in determining their satisfaction with care in this study. From a research perspective, this is an issue that warrants serious consideration, as patients' perceptions of personnel may account, in part, for observed differences between treatment groups in clinical studies. Consequently, it is important for researchers to attempt to balance this factor among treatment groups through appropriate training and monitoring.
Prior to undertaking this study, the investigators were concerned about the additional burden the qualitative interviews might place on participants in the randomized clinical pilot study. Specifically, it was speculated that participants may be unable to concentrate or unwilling to participate in the interviews, as they were conducted at the end of a 2–hour clinic visit. The general sense, however, was to the contrary. Most participants welcomed the opportunity to verbalize their opinions to the investigators, as opposed to filling out self-report questionnaires with a standard set of response choices. This not only allowed study participants to convey their thoughts and viewpoints but also provided investigators with a unique opportunity to more fully understand them.
While the qualitative techniques used in this study provided interesting insights into patients' perspectives, they are not without limitations. For instance, one limitation of qualitative research is that the viewpoint of a group of participants can never represent an absolute truth.  It is also noteworthy that the study population was overall a satisfied and improved group of patients. It is quite possible that patients who are less satisfied and less improved as a result of treatment might also have very different perspectives regarding satisfaction and improvement. Also, this approach is limited in that patients' opinions were only captured at one interview, and it is possible that they might have changed over time. Future studies might want to examine the potential for change in patients' views and possible influencing factors. Further, a potential weakness of content analysis, as used in this study, is that the coding of text is subject to the interpretation of the investigators. To limit this, those analyzing text were trained to make uniform judgements within the context of an entire interview and were assessed regularly to ensure consistency with one another and with the objectives of the study.  Finally, it is worth noting that the design and implementation of qualitative research within quantitative studies should not be taken lightly. The additional time and financial resources required for interviewing, transcribing, and analyzing data can be substantial. Also, while there are many schools of thought regarding qualitative research methodology,  whichever approach is chosen should be done with the same rigor as high-quality quantitative research. 
It has become clear that the biopsychosocial model of LBP necessitates an approach to LBP care and research that is also multidimensional. It seems inadequate to learn that patients are more satisfied or more improved with one treatment compared to another, without understanding why they feel this way. Integrating qualitative research techniques into traditionally quantitative clinical trials can enhance the interpretation and application of clinical studies by providing a better understanding of subjective reporting and aid study investigators in the analysis of outcomes on a more intimate level. Qualitative interviews can also ensure that the outcome measures used in clinical studies are those that are most important to participants, and ultimately, to the general public.
The results of this study provide preliminary information regarding the issues sciatica patients take into consideration when determining their satisfaction with care and overall improvement. This study, performed within the context of a randomized clinical pilot study, also demonstrated that a “mixed methods” approach to clinical trials, using both qualitative and quantitative methods, is not only feasible but can provide interesting and useful information for trial interpretation and future study design. As treatment efficacy and patient satisfaction continue to be explored in clinical research, we recommend that both qualitative and quantitative methodologies be implemented into study protocols. By providing insight to patients' beliefs and perceptions, qualitative techniques may not only shape but also redefine the focus of patient-oriented research and health care.
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