Research objectives and general considerations for pragmatic clinical trials of pain treatments: IMMPACT statement

Abstract

Many questions regarding the clinical management of people experiencing pain and related health policy decision-making may best be answered by pragmatic controlled trials. To generate clinically relevant and widely applicable findings, such trials aim to reproduce elements of routine clinical care or are embedded within clinical workflows. In contrast with traditional efficacy trials, pragmatic trials are intended to address a broader set of external validity questions critical for stakeholders (clinicians, healthcare leaders, policymakers, insurers, and patients) in considering the adoption and use of evidence-based treatments in daily clinical care. This article summarizes methodological considerations for pragmatic trials, mainly concerning methods of fundamental importance to the internal validity of trials. The relationship between these methods and common pragmatic trials methods and goals is considered, recognizing that the resulting trial designs are highly dependent on the specific research question under investigation. The basis of this statement was an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) systematic review of methods and a consensus meeting. The meeting was organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public–private partnership. The consensus process was informed by expert presentations, panel and consensus discussions, and a preparatory systematic review. In the context of pragmatic trials of pain treatments, we present fundamental considerations for the planning phase of pragmatic trials, including the specification of trial objectives, the selection of adequate designs, and methods to enhance internal validity while maintaining the ability to answer pragmatic research questions.

Lack of pragmatic attitude of self-labelled pragmatic trials on manual therapy: A methodological review

“…The authors should be expected to screen previous literature to appraise what is already known about a given intervention before attempting a pRCTs. Ultimately, a sound background should be provided alongside the rationale for attempting a pragmatic trial [90]. Such rationale might include existing mechanistic experiments and placebo-or sham-controlled e cacy trials, suggesting that the intervention has the desired physiological effects and e cacy [91].…”

Pain Research and Treatment: Policy Implications

“…In the context of pain, novel approaches that go past traditional efficacy trials may be needed. For example, pragmatic trials that consider a more comprehensive set of external validity questions critical for patients, clinicians, and policy makers may prove useful (Hohenschurz-Schmidt et al, 2023). The use of real-world data, or health data that is routinely collected for research purposes, is another novel approach.…”

“…The use of real-world data, or health data that is routinely collected for research purposes, is another novel approach. A systematic review of this methodology demonstrates that, if rigorous quality standards are met, this approach can be valuable in generating highquality evidence that goes beyond clinical trials (Vollert et al, 2023). Finally, emerging technologies such as machine learning can help construct prognostic profiles (Zmudzki and Smeets, 2023) and therefore aid in treatment personalization and outcome optimization.…”

Waste not, want not: call to action for spinal manipulative therapy researchers

“…• Conducting systematic reviews and meta-analyses : the Cochrane Handbook for Systematic Reviews of Interventions [ 102 ] provides extensive methodological guidelines. • Designing pragmatic trials : a dedicated IMMPACT statement [ 103 ] summarises relevant methodological considerations for the design and conduct of pragmatic trials of pain interventions. • Enhancing control interventions : the CoPPS statement [ 85 ] makes “recommendations for designing, conducting, and reporting control interventions” that are relevant for SMT research.…”