A novel preference-informed complementary trial (PICT) design for clinical trial research influenced by strong patient preferences

Background: Patients and their families often have preferences for medical care that relate to wider considerations beyond the clinical effectiveness of the proposed interventions. Traditionally, these preferences have not been adequately considered in research. Research questions where patients and families have strong preferences may not be appropriate for traditional randomized controlled trials (RCTs) due to threats to internal and external validity, as there may be high levels of drop-out and non-adherence or recruitment of a sample that is not representative of the treatment population. Several preference-informed designs have been developed to address problems with traditional RCTs, but these designs have their own limitations and may not be suitable for many research questions where strong preferences and opinions are present. Methods: In this paper, we propose a novel and innovative preference-informed complementary trial (PICT) design which addresses key weaknesses with both traditional RCTs and available preference-informed designs. In the PICT design, complementary trials would be operated within a single study, and patients and/or families would be given the opportunity to choose between a trial with all treatment options available and a trial with treatment options that exclude the option which is subject to strong preferences. This approach would allow those with strong preferences to take part in research and would improve external validity through recruiting more representative populations and internal validity. Here we discuss the strengths and limitations of the PICT design and considerations for analysis and present a motivating example for the design based on the use of opioids for pain management for children with musculoskeletal injuries. Conclusions: PICTs provide a novel and innovative design for clinical trials with more than two arms, which can address problems with existing preference-informed trial designs and enhance the ability of researchers to reflect shared decision-making in research as well as improving the validity of trials of topics with strong preferences

Treating and reducing anxiety and pain in the paediatric emergency department-TIME FOR ACTION-the TRAPPED quality improvement collaborative.

Background/Objectives In 2013, the TRAPPED-1 survey reported inconsistent availability of pain and distress management strategies across all 15 Canadian paediatric emergency department (PEDs). The objective of the TRAPPED-2 study was to utilize a procedural pain quality improvement collaborative (QIC) and evaluate the number of newly introduced pain and distress-reducing strategies in Canadian PEDs over a 2-year period. Methods A QIC was created to increase implementation of new strategies, through collaborative information sharing among PEDs. In 2015, 11 of the 15 Canadian PEDs participated in the TRAPPED QIC. At the end of the year, the TRAPPED-2 survey was electronically sent to a representative member at each of the 15 PEDs. The successful introduction of the chosen strategies by the QIC was assessed as well as the addition of new strategies per site. The number of new strategies introduced in the participating and nonparticipating QIC sites were described. Results All 15 PEDs (100%) completed the TRAPPED-2 survey. Overall, 10/11 of QIC-participating sites implemented the strategy they had initially identified. All 15 Canadian PEDs implemented some new strategies during the study period; participants in the QIC reported a mean of 5.2 (1-11) new strategies compared to 2.5 (1-4) in the nonactively participating sites. Conclusion While all PEDs introduced new strategies during the study, QIC-participating sites successfully introduced the majority of their previously identified new strategies in a short time period. Sharing deadlines and information between centres may have contributed to this success