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

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.

Core Domains for Clinical Research in Acute Respiratory Failure Survivors: An International Modified Delphi Consensus Study

“…Current guidelines recommend that these treatment decisions be shared by patients, their families, and their clinicians (36), making them the ultimate end-users of research. However, the potential benefits of many COS have not been realized because the COS was not widely adopted by clinical researchers who perform trials (37, 38). Unless research funders and journal editors require the use of COS, clinical researchers may not fully embrace them.…”

A developmental perspective on the impact of chronic pain in late adolescence and early adulthood: implications for assessment and intervention

“…Considerable literature has been published on outcome measures and domains relevant to assess in clinical trials of chronic pain treatments [13;31;34;51;52]. An underlying principle of patient-reported outcomes is that they reflect areas of personal relevance.…”

Repurposing Medications for Hospice/Palliative Care Symptom Control Is No Longer Sufficient: A Manifesto for Change

“…Regulatory agencies are indicating a desire for coprimary end points that have an objective measure, or other approaches, such as the multidomain subjective measures as illustrated by the nine domain measures for chronic pain in the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials. 26 This type of guidance, however, has not appeared for studies of clinical issues related to illness burden in populations with serious or life-limiting illnesses. Without specific regulatory guidance on symptom outcome measures, it is difficult to design, conduct, and analyze symptomcontrol studies that will satisfy the threshold for registering new medications for symptom control, or new indications for existing medications.…”