Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 26 professionals from academia, governmental agencies, and the pharmaceutical industry participated in a 2-stage Delphi poll and a consensus meeting that identified core outcome domains and measures that should be considered in clinical trials of treatments for acute and chronic pain in children and adolescents. Consensus was refined by consultation with the international pediatric pain community through announcement of our recommendations on the Pediatric Pain List and inviting and incorporating comments from external sources. There was consensus that investigators conducting pediatric acute pain clinical trials should consider assessing outcomes in pain intensity; global judgment of satisfaction with treatment; symptoms and adverse events; physical recovery; emotional response; and economic factors. There was also agreement that investigators conducting pediatric clinical trials in chronic and recurrent pain should consider assessing outcomes in pain intensity; physical functioning; emotional functioning; role functioning; symptoms and adverse events; global judgment of satisfaction with treatment; sleep; and economic factors. Specific measures or measurement strategies were recommended for different age groups for each domain. PERSPECTIVE: Based on systematic review and consensus of experts, core domains and measures for clinical trials to treat pain in children and adolescents were defined. This will assist in comparison and pooling of data and promote evidence-based treatment, encourage complete reporting of outcomes, simplify the review of proposals and manuscripts, and facilitate clinicians making informed decisions regarding treatment.
AimTo identify core outcome domains and measures that should be considered in clinical trials of treatments for acute and chronic pain in children and adolescents.
ContributorsMcGrath, Patrick J. Walco, Gary A. Turk, Dennis C. Dworkin, Robert H. Brown, Mark T. Davidson, Karina Eccleston, Christopher Finley, G. Allen Goldschneider, Kenneth Haverkos, Lynne Hertz, Sharon H. Ljungman, Gustaf Palermo, Tonya Rappaport, Bob A. Rhodes, Thomas Schechter, Neil Scott, Jane Sethna, Navil Svensson, Ola K. Stinson, Jennifer von Baeyer, Carl L. Walker, Lynn Weisman, Steven White, Richard E. Zajicek, Anne Zeltzer, Lonnie PedImmpact,
Disease Category: Anaesthesia & pain control, Child health
Disease Name: Pain (chronic), Pain (acute)
Age Range: 3 - 16
Sex: Either
Nature of Intervention: Any
- Academic research representatives
- Governmental agencies
- Regulatory agency representatives
- Pharmaceutical industry representatives
- Clinical experts
- Methodologists
- Epidemiologists
- Prioritising
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
The PedIMMPACT group first obtained consensus on domains to be used for acute and chronic pain using the age groups of 3 to 6 years and 7 years and up. Next, the availability and adequacy of measures within each domain were considered. When there was insufficient empirical data available to make an evidence-based recommendation, consensus was sought among the participants. Pain in neonates and infants was not considered because of the significant developmental differences between infants and neonates, on one hand, and children and adolescents on the other. PedIMMPACT also did not consider pain in cognitively impaired children because of differences in assessing these children. Efforts to develop standards for these populations will be the focus of future PedIMMPACT meetings.
The consensus group was constructed to represent the broadest spectrum of expertise in pediatric pain while keeping the group small enough to accomplish the goals and to permit free-ranging discussion and debate. We used a consensus strategy that consisted of a 2-stage Delphi poll that helped the group focus attention on relevant domains and measures during a 2-day consensus meeting (March 17–19, 2005). The consensus was refined using commissioned systematic reviews of self-report and observational measures of pain intensity. We finalized consensus through post-meeting consultation among the group using e-mail. Finally, we subjected our major findings to public review by the international pediatric pain community by means of dissemination on the Pediatric Pain Listserv (http://pediatric-pain.ca/ppml/), which is subscribed to by more than 450 researchers and clinicians who are working in pediatric pain in more than 45 countries. Suggestions obtained from this process were incorporated within our recommendations.
There were 3 groups of stakeholders represented: Academic research, government funding and regulatory agencies, and the pharmaceutical industry. The academic participants were selected by the organizers to represent the interdisciplinary international pediatric pain clinical research community and included representation from anesthesiology, clinical trials methods, epidemiology, neurology, nursing, pediatrics, pediatric oncology, psychology, and rehabilitation medicine. The meeting was chaired by the senior author (McGrath), who was assisted by the 2 coleaders of previous IMMPACT meetings (Turk and Dworkin) and was attended by a total of 26 professionals, all of whom are coauthors of this report. The representatives from industry were all scientists and not
directly involved in marketing. Each company was allowed 1 participant in the consensus process. The representatives from the United States Food and Drug Administration and the National Institutes of Health were involved in assessment of interventions used in children and adolescents for pain. Each participant was instructed to speak for himself or herself as an individual and not as a representative of any organization. All participants were involved in the Delphi poll, the consensus meeting, post-consensus consultations, and approved the manuscript and all revisions.
A 2-stage Delphi poll was conducted before a 2-day consensus meeting that discussed the results of the poll and made final recommendations. The Delphi poll was conducted by e-mail and asked participants to rate the outcome domains that had been suggested in the original IMMPACT recommendations and to recommend others. This information was solicited for acute pain and for chronic pain in 2 age groups (3–6 years and 7–16 years). The participants were also asked to suggest possible measures for each domain. The results from the first poll were summarized and were supplied to the participants for the repeat poll. The Delphi poll results were used as a guide to structure the discussion at the consensus meeting. The meeting reviewed the results of the Delphi poll and discussed acute pain domains and measures and then went on to examine domains and measures for chronic and recurrent pain. Because of the wealth of
research on measures of pain intensity and the need to carefully consider the extensive data available, systematic reviews were commissioned that reviewed scales for measurement of pain by self-report and by observation of behavior.