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Pain. 2015 Sep;156(9):1615-9. doi: 10.1097/j.pain.0000000000000241.

Reporting of IMMPACT-recommended core outcome domains among trials assessing opioids for chronic non-cancer pain.

Author information

1
aDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada bOutcomes Research Consortium, Cleveland, OH, USA cFaculty of Science, McMaster University, Hamilton, ON, Canada dPharmaceutical Sciences Postgraduate Course, University of Sorocaba, Sao Paulo, Brazil eSwiss Academy of Insurance Medicine, University Hospital Basel, Basel, Switzerland fBasel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland gDepartment of Family Medicine, McMaster University, Hamilton, ON, Canada hInstitute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway iAccident and Emergency Department, Tseung Kwan O Hospital, Hong Kong, China jAccident and Emergency Department, Tuen Mun Hospital, Hong Kong, China kDepartment of Anesthesia, McMaster University, Hamilton, ON, Canada lStanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, USA mDepartment of Anesthesia and Pain Medicine, The Hospital for Sick Children, Toronto, ON, Canada nInstitute for Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada oChild Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada pDepartment of Anesthesia, University of Calgary, Calgary, AB, Canada qDepartment of Dentistry, Santo Tomas University, Bogota, Colombia rDepartment of Anesthesia, University Hospital Basel, Basel, Switzerland sMichael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, ON, Canada tDepartment of Outcomes Research, Cleveland Clinic, Cleveland, OH, USA uDepartment of Medicine, McMaster University, Hamilton, ON, Canada.

Abstract

The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) has recommended that trialists evaluating treatments for chronic pain should consider reporting 9 patient-important outcome domains. We examined the extent to which clinical trials evaluating the effect of opioids for chronic non-cancer pain (CNCP) report outcome domains recommended by IMMPACT. We systematically searched electronic databases for English-language studies that randomized patients with CNCP to receive an opioid or a non-opioid control. In duplicate and independently, reviewers established the eligibility of each identified study and recorded all reported outcome domains from eligible trials. We conducted a priori regression analyses to explore factors that may be associated with IMMPACT-recommended outcome domains. Among 156 eligible trials, reporting of IMMPACT-recommended outcome domains was highly variable, ranging from 99% for pain to 7% for interpersonal functioning. Recently published trials were more likely to report the effect of treatment on physical functioning, emotional functioning, role functioning, sleep and fatigue, and participant disposition. Trials for which the corresponding author was from North America were more likely to report treatment effects on physical functioning and participant ratings of improvement and satisfaction with treatment. Trials published in higher impact journals were more likely to report treatment effects on emotional function, but less likely to report participant ratings of improvement and satisfaction with treatment. Most IMMPACT domains showed an increased rate of reporting over time, although many patient-important outcome domains remained unreported by over half of all trials evaluating the effects of opioids for CNCP.

PMID:
26020224
DOI:
10.1097/j.pain.0000000000000241
[Indexed for MEDLINE]

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