Interpreting the Clinical Importance of Treatment Outcomes in Chronic Pain Clinical Trials: IMMPACT Recommendations

Purpose To update eligibility and outcome measures in trials that evaluate systemic treatment for patients with progressive prostate cancer and castrate levels of testosterone. Methods A committee of investigators experienced in conducting trials for prostate cancer defined new consensus criteria by reviewing previous criteria, Response Evaluation Criteria in Solid Tumors (RECIST), and emerging trial data.

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Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group.

The objective of the present research was to develop a single measure of the major symptoms of both neuropathic and non-neuropathic pain that can be used in studies of epidemiology, natural history, pathophysiologic mechanisms, and treatment response. We expanded and revised the Short-form McGill Pain Questionnaire (SF-MPQ) pain descriptors by adding symptoms relevant to neuropathic pain and by modifying the response format to a 0-10 numerical rating scale to provide increased responsiveness in longitudinal studies and clinical trials. The reliability, validity, and subscale structure of the revised SF-MPQ (SF-MPQ-2) were examined in responses from 882 individuals with diverse chronic pain syndromes and in 226 patients with painful diabetic peripheral neuropathy who participated in a randomized clinical trial. The data suggest that the SF-MPQ-2 has excellent reliability and validity, and the results of both exploratory and confirmatory factor analyses provided support for four readily interpretable subscales-continuous pain, intermittent pain, predominantly neuropathic pain, and affective descriptors. These results provide a basis for use of the SF-MPQ-2 in future clinical research, including clinical trials of treatments for neuropathic and non-neuropathic pain conditions.

https://westicu.cn/upfile/201406/2014062643591953.pdf

Development and initial validation of an expanded and revised version of the Short-form McGill Pain Questionnaire (SF-MPQ-2)

Background Regional anaesthesia may reduce the risk of persistent (chronic) pain after surgery, a frequent and debilitating condition. We compared regional anaesthesia vs conventional analgesia for the prevention of persistent postoperative pain (PPP). Methods We searched the Cochrane Central Register of Controlled Trials, PubMed, EMBASE, and CINAHL from their inception to May 2012, limiting the results to randomized, controlled, clinical trials (RCTs), supplemented by a hand search in conference proceedings. We included RCTs comparing regional vs conventional analgesia with a pain outcome at 6 or 12 months. The two authors independently assessed methodological quality and extracted data. We report odds ratios (ORs) with 95% confidence intervals (CIs) as our summary statistic based on random-effects models. We grouped studies according to surgical interventions. Results We identified 23 RCTs. We pooled data from 250 participants in three trials after thoracotomy with outcomes at 6 months. Data favoured epidural anaesthesia for the prevention of PPP with an OR of 0.33 (95% CI 0.20–0.56). We pooled two studies investigating paravertebral block for breast cancer surgery; pooled data of 89 participants with outcomes ∼6 months favoured paravertebral block with an OR of 0.37 (95% CI 0.14–0.94). Adverse effects were reported sparsely. Conclusions Epidural anaesthesia and paravertebral block, respectively, may prevent PPP after thoracotomy and breast cancer surgery in about one out of every four to five patients treated. Small numbers, performance bias, attrition, and incomplete outcome data especially at 12 months weaken our conclusions.

Regional anaesthesia to prevent chronic pain after surgery: a Cochrane systematic review and meta-analysis

There has been an increase in the number of chronic pain clinical trials in which the treatments being evaluated did not differ significantly from placebo in the primary efficacy analyses despite previous research suggesting that efficacy could be expected. These findings could reflect a true lack of efficacy or methodological and other aspects of these trials that compromise the demonstration of efficacy. There is substantial variability among chronic pain clinical trials with respect to important research design considerations, and identifying and addressing any methodological weaknesses would enhance the likelihood of demonstrating the analgesic effects of new interventions. An IMMPACT consensus meeting was therefore convened to identify the critical research design considerations for confirmatory chronic pain trials and to make recommendations for their conduct. We present recommendations for the major components of confirmatory chronic pain clinical trials, including participant selection, trial phases and duration, treatment groups and dosing regimens, and types of trials. Increased attention to and research on the methodological aspects of confirmatory chronic pain clinical trials has the potential to enhance their assay sensitivity and ultimately provide more meaningful evaluations of treatments for chronic pain.

Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations.

Review and recommendations Developing patient-reported outcome measures for pain clinical trials: IMMPACT recommendations

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Review and recommendations Developing patient-reported outcome measures for pain clinical trials: IMMPACT recommendations