Methodology Issues In Evaluating Chronic Pain

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The primary problem in evaluating chronic pain is to define relevant outcome measures that can provide an estimate of "success of treatment" consistent with the therapeutic procedure. Caution needs to be exercised in collecting, analyzing, and interpreting outcome data because of two important conceptual concerns. First, there are no satisfactory objective indicators of pain that are universally applicable and acceptable. Second, every outcome is prone to some degree of error during design, collection, analysis, or interpretation. An attempt to define and apply quality control helps in obtaining dependable data. Other factors that need to be considered when evaluating outcomes include the demographic makeup, inpatient/outpatient status, and the credibility of the treatment procedures in the patient population.133 Issues related to referral patterns, adherence to treatment, and attrition of the initial study group need attention. "Reactivity," which is a measure of inherent subjectivity of the outcome measures also needs to be taken into account when drawing conclusions from outcome analysis. For instance, in one meta-analytic review,133 it was found that only 3% of the 65 pain clinic treatment outcome studies included measures of low reactivity and that only 29% of them assessed outcomes with acceptable levels of reliability and validity. Additional criteria of importance include efficiency, consumer evaluation such as patient satisfaction, and the distinction between statistical and clinical significance. Furthermore, moderately efficacious but inexpensive strategies may be applied more efficiently to a larger patient population than highly efficacious interventions that may be more expensive. There is increasing speculation that group interventions, home self-care, and service through nonprofessionals may be highly cost-effective options.133 Despite all the efforts to minimize misinterpretation of the results of outcomes, there remains a potential for overestimating the effects of treatment procedures. Placebo effects, regression to the mean, and natural history of disease may falsely result in good outcomes. Therefore, care needs to be exercised when inferences are drawn from studies that are not well-controlled, randomized trials.133

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