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Browsing by Author "Turk, Dennis C."
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Item A practical guide to recognize, assess, treat and evaluate (RATE) primary care patients with chronic pain(Taylor & Francis, 2023) Gebke, Kevin B.; McCarberg, Bill; Shaw, Erik; Turk, Dennis C.; Wright, Wendy L.; Semel, David; Medicine, School of MedicineThe management of patients with chronic pain is one of the most important issues In medicine and public health. Chronic pain conditions cause substantial suffering for patients, their significant others and society over years and even decades and increases healthcare utilization resources including the cost of medical care, loss of productivity and provision of disability services. Primary care providers are at the frontline in the identification and management of patients with chronic pain, as the majority of patients enter the healthcare system through primary care and are managed by primary care providers. Due to the complexity of chronic pain and the range of issues involved, the accurate diagnosis of the causes of pain and the formulation of effective treatment plans presents significant challenges in the primary care setting. In this review, we use the classification of pain types based on pathophysiology as the template to guide the assessment, treatment, and monitoring of patients with chronic pain conditions. We outline key methods that can be used to efficiently and accurately diagnose the putative pathophysiological mechanisms underlying chronic pain conditions and describe how this information should be used to tailor the treatment plan to meet the patient's needs. We discuss methods to evaluate patients and the impact of treatment plans over a series of consultations, with a particular focus on strategies to improve the patient's ability to self-manage their pain and related symptoms and perform daily functions despite persistent pain. Finally, we introduce the mnemonic RATE (Recognize, Assess, Treat, and Evaluate) as a general strategy that healthcare providers can use to aid their management of patients presenting with chronic pain.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 MedicinePragmatic, 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.Item Research approaches for evaluating opioid sparing in clinical trials of acute and chronic pain treatments: Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials recommendations(International Association for the Study of Pain, 2021) Gewandter, Jennifer S.; Smith, Shannon M.; Dworkin, Robert H.; Turk, Dennis C.; Gan, Tong Joo; Gilron, Ian; Hertz, Sharon; Katz, Nathaniel P.; Markman, John D.; Raja, Srinivasa N.; Rowbotham, Michael C.; Stacey, Brett R.; Strain, Eric C.; Ward, Denham S.; Farrar, John T.; Kroenke, Kurt; Rathmell, James P.; Rauck, Richard; Brown, Colville; Cowan, Penney; Edwards, Robert R.; Eisenach, James C.; Ferguson, McKenzie; Freeman, Roy; Gray, Roy; Giblin, Kathryn; Grol-Prokopczyk, Hanna; Haythornthwaite, Jennifer; Jamison, Robert N.; Martel, Marc; McNicol, Ewan; Oshinsky, Michael; Sandbrink, Friedhelm; Scholz, Joachim; Scranton, Richard; Simon, Lee S.; Steiner, Deborah; Verburg, Kenneth; Wasan, Ajay D.; Wentworth, Kerry; Medicine, School of MedicineRandomized clinical trials have demonstrated the efficacy of opioid analgesics for the treatment of acute and chronic pain conditions, and for some patients, these medications may be the only effective treatment available. Unfortunately, opioid analgesics are also associated with major risks (eg, opioid use disorder) and adverse outcomes (eg, respiratory depression and falls). The risks and adverse outcomes associated with opioid analgesics have prompted efforts to reduce their use in the treatment of both acute and chronic pain. This article presents Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus recommendations for the design of opioid-sparing clinical trials. The recommendations presented in this article are based on the following definition of an opioid-sparing intervention: any intervention that (1) prevents the initiation of treatment with opioid analgesics, (2) decreases the duration of such treatment, (3) reduces the total dosages of opioids that are prescribed for or used by patients, or (4) reduces opioid-related adverse outcomes (without increasing opioid dosages), all without causing an unacceptable increase in pain. These recommendations are based on the results of a background review, presentations and discussions at an IMMPACT consensus meeting, and iterative drafts of this article modified to accommodate input from the co-authors. We discuss opioid sparing definitions, study objectives, outcome measures, the assessment of opioid-related adverse events, incorporation of adequate pain control in trial design, interpretation of research findings, and future research priorities to inform opioid-sparing trial methods. The considerations and recommendations presented in this article are meant to help guide the design, conduct, analysis, and interpretation of future trials.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 MedicineMany 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.