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

التفاصيل البيبلوغرافية
العنوان: Research objectives and general considerations for pragmatic clinical trials of pain treatments: IMMPACT statement.
المؤلفون: Hohenschurz-Schmidt DJ; Pain Research, Department of Surgery & Cancer, Faculty of Medicine, Imperial College London, London, United Kingdom., Cherkin D; Department of Family Medicine, University of Washington and Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States., Rice ASC; Pain Research, Department of Surgery & Cancer, Faculty of Medicine, Imperial College London, London, United Kingdom., Dworkin RH; Department of Anesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, NY, United States., Turk DC; Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, United States., McDermott MP; Department of Biostatistics and Computational Biology, University of Rochester, Rochester, NY, United States., Bair MJ; VA Center for Health Information and Communication, Regenstrief Institute, and Indiana University School of Medicine, Indianapolis, IN, United States., DeBar LL; Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States., Edwards RR; Harvard Medical School, Boston, MA, United States., Farrar JT; Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, PA, United States., Kerns RD; Departments of Psychiatry, Neurology and Psychology, Yale University, New Haven, CT, United States., Markman JD; Neuromedicine Pain Management and Translational Pain Research, University of Rochester School of Medicine and Dentistry, Rochester, NY, United States., Rowbotham MC; Department of Anesthesia, University of California San Francisco School of Medicine, San Francisco, CA, United States., Sherman KJ; Kaiser Permanente Washington Health Research Institute and Department of Epidemiology, University of Washington, Seattle WA, United States., Wasan AD; Departments of Anesthesiology & Perioperative Medicine, and Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States., Cowan P; American Chronic Pain Association, Rocklin, CA, United States., Desjardins P; Department of Diagnostic Sciences, School of Dental Medicine, Rutgers University, Newark, NJ, United States., Ferguson M; Department of Pharmacy Practice, Southern Illinois University Edwardsville, Edwardsville, IL, United States., Freeman R; Department of Neurology, Harvard Medical School, Boston, MA, United States., Gewandter JS; Department of Anesthesiology and Perioperative, University of Rochester, Rochester, NY, United States., Gilron I; Departments of Anesthesiology & Perioperative Medicine, Biomedical & Molecular Sciences, Centre for Neuroscience Studies, and School of Policy Studies, Queen's University, Kingston, ON, Canada., Grol-Prokopczyk H; Department of Sociology, University at Buffalo, State University of New York, Buffalo NY, United States., Hertz SH; Hertz and Fields Consulting, Inc, Silver Spring, MD, United States., Iyengar S; Eli Lilly and Company, Indianapolis, IN, United States., Kamp C; Center for Health and Technology (CHeT), Clinical Materials Services Unit (CMSU), University of Rochester Medical Center, Rochester, NY, United States., Karp BI; National Institutes of Health, Bethesda, MD, United States., Kleykamp BA; Department of Anesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, NY, United States., Loeser JD; Departments of Neurological Surgery and Anesthesia and Pain Medicine, University of Washington, Seattle, WA, United States., Mackey S; Department of Anesthesiology, Perioperative, and Pain Medicine, Neurosciences and Neurology, Stanford University School of Medicine, Palo Alto, CA, United States., Malamut R; Collegium Pharmaceuticals, Stoughton, MA, United States., McNicol E; Department of Pharmacy Practice, Massachusetts College of Pharmacy and Health Sciences, Boston, MA, United States., Patel KV; Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, United States., Sandbrink F; Department of Neurology, Washington DC Veterans Affairs Medical Center, Washington, DC, United States.; Department of Neurology, George Washington University, Washington, DC, United States., Schmader K; Department of Medicine-Geriatrics, Center for the Study of Aging, Duke University Medical Center, and Geriatrics Research Education and Clinical Center, Durham VA Medical Center, Durham, NC, United States., Simon L; SDG, LLC, Cambridge, MA, United States., Steiner DJ; Eli Lilly and Company, Indianapolis, IN, United States., Veasley C; Chronic Pain Research Alliance, North Kingstown, RI, United States., Vollert J; Pain Research, Department of Surgery and Cancer, Imperial College London, London, United Kingdom.; Division of Neurological Pain Research and Therapy, Department of Neurology, University Hospital of Schleswig-Holstein, Campus Kiel, Germany.; Department of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Muenster, Muenster, Germany.; Neurophysiology, Mannheim Center of Translational Neuroscience (MCTN), Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.
المصدر: Pain [Pain] 2023 Jul 01; Vol. 164 (7), pp. 1457-1472. Date of Electronic Publication: 2023 Mar 22.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 7508686 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1872-6623 (Electronic) Linking ISSN: 03043959 NLM ISO Abbreviation: Pain Subsets: MEDLINE
أسماء مطبوعة: Publication: 2015- : Hagerstown, MD : Lippincott Williams & Wilkins
Original Publication: Amsterdam, Elsevier/North-Holland.
مواضيع طبية MeSH: Analgesics*/therapeutic use , Pain Management*, Humans ; Consensus ; Pain/drug therapy ; Research Design ; Pragmatic Clinical Trials as Topic
مستخلص: 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.
(Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the International Association for the Study of Pain.)
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المشرفين على المادة: 0 (Analgesics)
تواريخ الأحداث: Date Created: 20230321 Date Completed: 20230630 Latest Revision: 20231116
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC10281023
DOI: 10.1097/j.pain.0000000000002888
PMID: 36943273
قاعدة البيانات: MEDLINE
الوصف
تدمد:1872-6623
DOI:10.1097/j.pain.0000000000002888