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Prognostic variability among chronic pain patients: implications for study design, interpretation, and reporting.
R A Deyo1, J E Bass, N E Walsh
1Multipurpose Arthritis Center, University of Texas Health Science Center, San Antonio 78284.
Archives of Physical Medicine and Rehabilitation
|March 1, 1988
Summary
Patient recruitment methods significantly impact clinical trial outcomes for chronic pain. Differences in education, employment, and health status among participants, not just treatment, influence pain relief results.
Area of Science:
- Pain Management
- Clinical Research Methodology
- Patient Prognosis
Background:
- Chronic pain patients exhibit significant prognostic variability.
- Recruitment strategies and entry criteria can influence patient characteristics in clinical studies.
- Understanding these differences is crucial for interpreting research findings.
Purpose of the Study:
- To investigate how recruitment methods affect patient characteristics in a chronic pain clinical trial.
- To compare the baseline prognostic factors of patients recruited via lay publicity versus those from a routine pain clinic.
- To determine if observed differences in treatment outcomes are attributable to patient selection or therapy efficacy.
Main Methods:
- A clinical trial for chronic back pain therapy recruited 55 subjects through lay publicity.
- A comparison group of 61 patients was drawn from a routine pain clinic.
- Statistical analysis (p < 0.004) was used to compare baseline characteristics between the two groups.
Main Results:
- Clinical trial subjects were significantly better educated and more often employed than pain clinic patients.
- Trial participants exhibited more favorable personality profiles and were less likely to have prior surgery or narcotic use.
- Pain relief was significantly greater in the clinical trial group, suggesting baseline prognostic differences.
Conclusions:
- Chronic pain patient populations vary in prognostically significant ways.
- Recruitment methods and selection criteria strongly influence these patient characteristics.
- Greater attention to recruitment details is essential for accurate interpretation and reporting of clinical research on chronic pain.