Article type
Year
Abstract
Background:
Chronic non-cancer pain (CNCP) is common, but clinical trials exploring treatment options do not always report all outcomes of importance to patients. To address this issue, the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus has recommended nine core outcome domains when evaluating treatments for pain.
Objectives:
To examine the extent to which trials assessing the effect of opioids for CNCP adhere to IMMPACT recommendations.
Methods:
We searched several electronic databases systematically for English-language studies that randomized patients with CNCP to receive an opioid or a non-opioid control. In duplicate, and independently, teams of reviewers established the eligibility of each identified study, and recorded all reported outcome domains from trials that proved eligible.
Results:
Out of a total of 23,109 citations, 161 proved eligible. Table 1 presents study characteristics. The proportion of trials reporting IMMPACT-recommended outcome domains was variable across domains: 1) pain (99%), 2) physical functioning (46%), 3) emotional functioning (29%), 4) global improvement (44%), 5) adverse events (93%), 6) participant disposition (75%), 7) role functioning (17%), 8) interpersonal functioning (8%), and 9) impact on sleep/fatigue (31%). Although patients typically provided outcome data, many trials relied on clinician-reported outcomes or were unclear regarding the source (Table 2). With the exception of patient's rating of global improvement, pain, and adverse events, our adjusted analyses found that all IMMPACT domains showed an increased rate of reporting over time (adjusted odds ratios all > 2 for more recent date of publication, by decade).
Conclusions:
Trials evaluating the effect of opioids for CNCP show improved concordance with IMMPACT-recommended outcome domains over time; however, most recommended outcome domains are reported in fewer than half of published trials and the source of outcome information is often unclear.
Chronic non-cancer pain (CNCP) is common, but clinical trials exploring treatment options do not always report all outcomes of importance to patients. To address this issue, the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus has recommended nine core outcome domains when evaluating treatments for pain.
Objectives:
To examine the extent to which trials assessing the effect of opioids for CNCP adhere to IMMPACT recommendations.
Methods:
We searched several electronic databases systematically for English-language studies that randomized patients with CNCP to receive an opioid or a non-opioid control. In duplicate, and independently, teams of reviewers established the eligibility of each identified study, and recorded all reported outcome domains from trials that proved eligible.
Results:
Out of a total of 23,109 citations, 161 proved eligible. Table 1 presents study characteristics. The proportion of trials reporting IMMPACT-recommended outcome domains was variable across domains: 1) pain (99%), 2) physical functioning (46%), 3) emotional functioning (29%), 4) global improvement (44%), 5) adverse events (93%), 6) participant disposition (75%), 7) role functioning (17%), 8) interpersonal functioning (8%), and 9) impact on sleep/fatigue (31%). Although patients typically provided outcome data, many trials relied on clinician-reported outcomes or were unclear regarding the source (Table 2). With the exception of patient's rating of global improvement, pain, and adverse events, our adjusted analyses found that all IMMPACT domains showed an increased rate of reporting over time (adjusted odds ratios all > 2 for more recent date of publication, by decade).
Conclusions:
Trials evaluating the effect of opioids for CNCP show improved concordance with IMMPACT-recommended outcome domains over time; however, most recommended outcome domains are reported in fewer than half of published trials and the source of outcome information is often unclear.