Browsing by Author "Patel, Kushang V."

Now showing 1 - 2 of 2
  • Thumbnail Image
    Item
    Methods for pragmatic randomized clinical trials of pain therapies: IMMPACT statement
    (Wolters Kluwer, 2024) Hohenschurz-Schmidt, David; Cherkin, Dan; Rice, Andrew S. C.; Dworkin, Robert H.; Turk, Dennis C.; McDermott, Michael P.; Bair, Matthew J.; DeBar, Lynn L.; Edwards, Robert R.; Evans, Scott R.; Farrar, John T.; Kerns, Robert D.; Rowbotham, Michael C.; Wasan, Ajay D.; Cowan, Penney; Ferguson, McKenzie; Freeman, Roy; Gewandter, Jennifer S.; Gilron, Ian; Grol-Prokopczyk, Hanna; Iyengar, Smriti; Kamp, Cornelia; Karp, Barbara I.; Kleykamp, Bethea A.; Loeser, John D.; Mackey, Sean; Malamut, Richard; McNicol, Ewan; Patel, Kushang V.; Schmader, Kenneth; Simon, Lee; Steiner, Deborah J.; Veasley, Christin; Vollert, Jan; Medicine, School of Medicine
    Pragmatic, randomized, controlled trials hold the potential to directly inform clinical decision making and health policy regarding the treatment of people experiencing pain. Pragmatic trials are designed to replicate or are embedded within routine clinical care and are increasingly valued to bridge the gap between trial research and clinical practice, especially in multidimensional conditions, such as pain and in nonpharmacological intervention research. To maximize the potential of pragmatic trials in pain research, the careful consideration of each methodological decision is required. Trials aligned with routine practice pose several challenges, such as determining and enrolling appropriate study participants, deciding on the appropriate level of flexibility in treatment delivery, integrating information on concomitant treatments and adherence, and choosing comparator conditions and outcome measures. Ensuring data quality in real-world clinical settings is another challenging goal. Furthermore, current trials in the field would benefit from analysis methods that allow for a differentiated understanding of effects across patient subgroups and improved reporting of methods and context, which is required to assess the generalizability of findings. At the same time, a range of novel methodological approaches provide opportunities for enhanced efficiency and relevance of pragmatic trials to stakeholders and clinical decision making. In this study, best-practice considerations for these and other concerns in pragmatic trials of pain treatments are offered and a number of promising solutions discussed. The basis of these recommendations was an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) meeting organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks.
  • Thumbnail Image
    Item
    Research objectives and general considerations for pragmatic clinical trials of pain treatments: IMMPACT statement
    (Wolters Kluwer, 2023) Hohenschurz-Schmidt, David J.; Cherkin, Dan; Rice, Andrew S. C.; Dworkin, Robert H.; Turk, Dennis C.; McDermott, Michael P.; Bair, Matthew J.; DeBar, Lynn L.; Edwards, Robert R.; Farrar, John T.; Kerns, Robert D.; Markman, John D.; Rowbotham, Michael C.; Sherman, Karen J.; Wasan, Ajay D.; Cowan, Penney; Desjardins, Paul; Ferguson, McKenzie; Freeman, Roy; Gewandter, Jennifer S.; Gilron, Ian; Grol-Prokopczyk, Hanna; Hertz, Sharon H.; Iyengar, Smriti; Kamp, Cornelia; Karp, Barbara I.; Kleykamp, Bethea A.; Loeser, John D.; Mackey, Sean; Malamut, Richard; McNicol, Ewan; Patel, Kushang V.; Sandbrink, Friedhelm; Schmader, Kenneth; Simon, Lee; Steiner, Deborah J.; Veasley, Christin; Vollert, Jan; Anesthesia, School of Medicine
    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.