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4. Methods for pragmatic randomized clinical trials of pain therapies: IMMPACT statement

Author

Hohenschurz-Schmidt, David, primary, Cherkin, Dan, additional, Rice, Andrew S.C., additional, Dworkin, Robert H., additional, Turk, Dennis C., additional, McDermott, Michael P., additional, Bair, Matthew J., additional, DeBar, Lynn L., additional, Edwards, Robert R., additional, Evans, Scott R., additional, Farrar, John T., additional, Kerns, Robert D., additional, Rowbotham, Michael C., additional, Wasan, Ajay D., additional, Cowan, Penney, additional, Ferguson, McKenzie, additional, Freeman, Roy, additional, Gewandter, Jennifer S., additional, Gilron, Ian, additional, Grol-Prokopczyk, Hanna, additional, Iyengar, Smriti, additional, Kamp, Cornelia, additional, Karp, Barbara I., additional, Kleykamp, Bethea A., additional, Loeser, John D., additional, Mackey, Sean, additional, Malamut, Richard, additional, McNicol, Ewan, additional, Patel, Kushang V., additional, Schmader, Kenneth, additional, Simon, Lee, additional, Steiner, Deborah J., additional, Veasley, Christin, additional, and Vollert, Jan, additional

Published
2024
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5. Impact of American Diabetes Association 2022 Guidelines on Prescribing Rates of Sodium-Glucose Cotransporter-2 Inhibitors in Ambulatory Care Organization Patients With Type 2 Diabetes.

Author

Bogannam, Alexis R., McNicol, Ewan, DeLeonardo, Kevin, Ranade, Ashwini, and Zaiken, Kathy

Subjects
*MEDICAL protocols, *OUTPATIENT medical care, *ATHEROSCLEROSIS, *HEART failure, *RETROSPECTIVE studies, *DESCRIPTIVE statistics, *CHRONIC kidney failure, *TYPE 2 diabetes, *SODIUM-glucose cotransporter 2 inhibitors, *MEDICAL records, *ACQUISITION of data, *DRUGS
Abstract

Background: Recent clinical trials and guideline updates have highlighted the efficacy and safety of sodium-glucose cotransporter-2 inhibitor (SGLT2i) use in patients with type 2 diabetes (T2D) and comorbidities including atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD), or heart failure (HF). Objective: This study assesses the rates of guideline-based prescribing of SGLT2i in patients with T2D and one or more of the following comorbidities: ASCVD, CKD, or HF, prior to and after the 2022 American Diabetes Association (ADA) guideline publication within the Atrius Health clinical pharmacy, internal medicine, and specialty medicine departments. Methods: This is a retrospective chart review of data from the electronic medical record. Patients with the aforementioned criteria were included if they were managed by either the clinical pharmacy department, internal medicine, or specialty medicine departments. Patients were excluded if they did not have any of the comorbidities listed or a form of diabetes other than T2D. Results: Of the 10,631 patients enrolled, 354 (3.3%) were initiated on an SGLT2i during the study. The average number of SGLT2i initiations prior to the 2022 ADA guideline publication was five prescription starts per week. After the guideline publication initiation increased to seven prescription starts per week. Secondary outcomes showed the majority of SGLT2i prescriptions were started in the internal medicine department, followed by cardiology and nephrology. Conclusion: Overall utilization rates of SGLT2i are low but increased after the 2022 ADA guidelines were published. These results suggest opportunities to optimize the use of SGLT2i in this patient population. [ABSTRACT FROM AUTHOR]

Published
2024
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9. Patient engagement in designing, conducting, and disseminating clinical pain research: IMMPACT recommended considerations

Author

Haroutounian, Simon, primary, Holzer, Katherine J., additional, Kerns, Robert D., additional, Veasley, Christin, additional, Dworkin, Robert H., additional, Turk, Dennis C., additional, Carman, Kristin L., additional, Chambers, Christine T., additional, Cowan, Penney, additional, Edwards, Robert R., additional, Eisenach, James C., additional, Farrar, John T., additional, Ferguson, McKenzie, additional, Forsythe, Laura P., additional, Freeman, Roy, additional, Gewandter, Jennifer S., additional, Gilron, Ian, additional, Goertz, Christine, additional, Grol-Prokopczyk, Hanna, additional, Iyengar, Smriti, additional, Jordan, Isabel, additional, Kamp, Cornelia, additional, Kleykamp, Bethea A., additional, Knowles, Rachel L., additional, Langford, Dale J., additional, Mackey, Sean, additional, Malamut, Richard, additional, Markman, John, additional, Martin, Kathryn R., additional, McNicol, Ewan, additional, Patel, Kushang V., additional, Rice, Andrew S.C., additional, Rowbotham, Michael, additional, Sandbrink, Friedhelm, additional, Simon, Lee S., additional, Steiner, Deborah J., additional, and Vollert, Jan, additional

Published
2023
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10. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis

Author

Finnerup, Nanna B, Attal, Nadine, Haroutounian, Simon, McNicol, Ewan, Baron, Ralf, Dworkin, Robert H, Gilron, Ian, Haanpää, Maija, Hansson, Per, Jensen, Troels S, Kamerman, Peter R, Lund, Karen, Moore, Andrew, Raja, Srinivasa N, Rice, Andrew SC, Rowbotham, Michael, Sena, Emily, Siddall, Philip, Smith, Blair H, and Wallace, Mark

Subjects
Clinical Trials and Supportive Activities, Clinical Research, Neurodegenerative, Peripheral Neuropathy, Neurosciences, Pain Research, Chronic Pain, Substance Misuse, Drug Abuse (NIDA only), Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Analgesics, Opioid, Antidepressive Agents, Tricyclic, Humans, Neuralgia, Pain Management, Randomized Controlled Trials as Topic, Clinical Sciences, Neurology & Neurosurgery
Abstract

BackgroundNew drug treatments, clinical trials, and standards of quality for assessment of evidence justify an update of evidence-based recommendations for the pharmacological treatment of neuropathic pain. Using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE), we revised the Special Interest Group on Neuropathic Pain (NeuPSIG) recommendations for the pharmacotherapy of neuropathic pain based on the results of a systematic review and meta-analysis.MethodsBetween April, 2013, and January, 2014, NeuPSIG of the International Association for the Study of Pain did a systematic review and meta-analysis of randomised, double-blind studies of oral and topical pharmacotherapy for neuropathic pain, including studies published in peer-reviewed journals since January, 1966, and unpublished trials retrieved from ClinicalTrials.gov and websites of pharmaceutical companies. We used number needed to treat (NNT) for 50% pain relief as a primary measure and assessed publication bias; NNT was calculated with the fixed-effects Mantel-Haenszel method.Findings229 studies were included in the meta-analysis. Analysis of publication bias suggested a 10% overstatement of treatment effects. Studies published in peer-reviewed journals reported greater effects than did unpublished studies (r(2) 9·3%, p=0·009). Trial outcomes were generally modest: in particular, combined NNTs were 6·4 (95% CI 5·2-8·4) for serotonin-noradrenaline reuptake inhibitors, mainly including duloxetine (nine of 14 studies); 7·7 (6·5-9·4) for pregabalin; 7·2 (5·9-9·21) for gabapentin, including gabapentin extended release and enacarbil; and 10·6 (7·4-19·0) for capsaicin high-concentration patches. NNTs were lower for tricyclic antidepressants, strong opioids, tramadol, and botulinum toxin A, and undetermined for lidocaine patches. Based on GRADE, final quality of evidence was moderate or high for all treatments apart from lidocaine patches; tolerability and safety, and values and preferences were higher for topical drugs; and cost was lower for tricyclic antidepressants and tramadol. These findings permitted a strong recommendation for use and proposal as first-line treatment in neuropathic pain for tricyclic antidepressants, serotonin-noradrenaline reuptake inhibitors, pregabalin, and gabapentin; a weak recommendation for use and proposal as second line for lidocaine patches, capsaicin high-concentration patches, and tramadol; and a weak recommendation for use and proposal as third line for strong opioids and botulinum toxin A. Topical agents and botulinum toxin A are recommended for peripheral neuropathic pain only.InterpretationOur results support a revision of the NeuPSIG recommendations for the pharmacotherapy of neuropathic pain. Inadequate response to drug treatments constitutes a substantial unmet need in patients with neuropathic pain. Modest efficacy, large placebo responses, heterogeneous diagnostic criteria, and poor phenotypic profiling probably account for moderate trial outcomes and should be taken into account in future studies.FundingNeuPSIG of the International Association for the Study of Pain.

Published
2015

11. 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

Author

Gewandter, Jennifer S., Smith, Shannon M., Dworkin, Robert H., Turk, Dennis C., Gan, Tong J., 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, L. Oshinsky, Michael, Sandbrink, Friedhelm, Scholz, Joachim, Scranton, Richard, Simon, Lee S., Steiner, Deborah, Verburg, Kenneth, Wasan, Ajay D., and Wentworth, Kerry

Published
2021
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12. Research design considerations for randomized controlled trials of spinal cord stimulation for pain: IMMPACT/ION/INS recommendations

Author

Katz, Nathaniel, Dworkin, Robert H., North, Richard, Thomson, Simon, Eldabe, Sam, Hayek, Salim M., Kopell, Brian H., Markman, John, Rezai, Ali, Taylor, Rod S., Turk, Dennis C., Buchser, Eric, Fields, Howard, Fiore, Gregory, Ferguson, McKenzie, Gewandter, Jennifer, Hilker, Chris, Jain, Roshini, Leitner, Angela, Loeser, John, McNicol, Ewan, Nurmikko, Turo, Shipley, Jane, Singh, Rahul, Trescot, Andrea, van Dongen, Robert, and Venkatesan, Lalit

Published
2021
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15. Research objectives and general considerations for pragmatic clinical trials of pain treatments: IMMPACT statement

Author

Hohenschurz-Schmidt, David J., primary, Cherkin, Dan, additional, Rice, Andrew S.C., additional, Dworkin, Robert H., additional, Turk, Dennis C., additional, McDermott, Michael P., additional, Bair, Matthew J., additional, DeBar, Lynn L., additional, Edwards, Robert R., additional, Farrar, John T., additional, Kerns, Robert D., additional, Markman, John D., additional, Rowbotham, Michael C., additional, Sherman, Karen J., additional, Wasan, Ajay D., additional, Cowan, Penney, additional, Desjardins, Paul, additional, Ferguson, McKenzie, additional, Freeman, Roy, additional, Gewandter, Jennifer S., additional, Gilron, Ian, additional, Grol-Prokopczyk, Hanna, additional, Hertz, Sharon H., additional, Iyengar, Smriti, additional, Kamp, Cornelia, additional, Karp, Barbara I., additional, Kleykamp, Bethea A., additional, Loeser, John D., additional, Mackey, Sean, additional, Malamut, Richard, additional, McNicol, Ewan, additional, Patel, Kushang V., additional, Sandbrink, Friedhelm, additional, Schmader, Kenneth, additional, Simon, Lee, additional, Steiner, Deborah J., additional, Veasley, Christin, additional, and Vollert, Jan, additional

Published
2023
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21. Pragmatic trials of pain therapies: a systematic review of methods

Author

Hohenschurz-Schmidt, David, primary, Kleykamp, Bethea A., additional, Draper-Rodi, Jerry, additional, Vollert, Jan, additional, Chan, Jessica, additional, Ferguson, McKenzie, additional, McNicol, Ewan, additional, Phalip, Jules, additional, Evans, Scott R., additional, Turk, Dennis C., additional, Dworkin, Robert H., additional, and Rice, Andrew S.C., additional

Published
2021
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22. Risk factors for persistent pain after breast and thoracic surgeries: a systematic literature review and meta-analysis

Author

Lim, Joshua, primary, Chen, Dili, additional, McNicol, Ewan, additional, Sharma, Lokesh, additional, Varaday, Grihith, additional, Sharma, Anshuman, additional, Wilson, Elizabeth, additional, Wright-Yatsko, Tiffany, additional, Yaeger, Lauren, additional, Gilron, Ian, additional, Finnerup, Nanna B., additional, and Haroutounian, Simon, additional

Published
2021
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26. Systematic Review of Research Methods and Reporting Quality of Randomized Clinical Trials of Spinal Cord Stimulation for Pain

Author

McNicol, Ewan, primary, Ferguson, McKenzie, additional, Bungay, Kathleen, additional, Rowe, Emily L., additional, Eldabe, Sam, additional, Gewandter, Jennifer S., additional, Hayek, Salim M., additional, Katz, Nathaniel, additional, Kopell, Brian H., additional, Markman, John, additional, Rezai, Ali, additional, Taylor, Rod S., additional, Turk, Dennis C., additional, Dworkin, Robert H., additional, North, Richard B., additional, and Thomson, Simon, additional

Published
2021
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27. Research design considerations for randomized controlled trials of spinal cord stimulation for pain: Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials/Institute of Neuromodulation/International Neuromodulation Society recommendations

Author

Katz, Nathaniel, primary, Dworkin, Robert H., additional, North, Richard, additional, Thomson, Simon, additional, Eldabe, Sam, additional, Hayek, Salim M., additional, Kopell, Brian H., additional, Markman, John, additional, Rezai, Ali, additional, Taylor, Rod S., additional, Turk, Dennis C., additional, Buchser, Eric, additional, Fields, Howard, additional, Fiore, Gregory, additional, Ferguson, McKenzie, additional, Gewandter, Jennifer, additional, Hilker, Chris, additional, Jain, Roshini, additional, Leitner, Angela, additional, Loeser, John, additional, McNicol, Ewan, additional, Nurmikko, Turo, additional, Shipley, Jane, additional, Singh, Rahul, additional, Trescot, Andrea, additional, van Dongen, Robert, additional, and Venkatesan, Lalit, additional

Published
2021
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28. Efficacy and safety of opioid agonists in the treatment of neuropathic pain of nonmalignant origin

Author

Eisenberg, Elon, McNicol, Ewan D., and Carr, Daniel B.

Subjects
Opioids -- Usage, Pain -- Care and treatment, Pain -- Methods, Clinical trials
Abstract

The efficacy and safety of opioid agonists for the treatment of neuropathic pain is assessed with reference to published randomized controlled trials (RCTs). While short-term studies provide only equivocal evidence regarding the efficacy of opioids in reducing the intensity of neuropathic pain, further RCTs are needed to establish their long-term efficacy, safety, and effects on quality of life.

Published
2005

36. Single-dose intravenous ketorolac for acute postoperative pain in adults

Author

McNicol, Ewan D, Ferguson, McKenzie C, Gallagher, Sean, and Schumann, Roman

Subjects
Medicine General & Introductory Medical Sciences, Pharmacology (medical)
Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the analgesic efficacy and adverse effects of single‐dose IV ketorolac, compared with placebo or an active comparator, for moderate‐to‐severe postoperative pain in adults.

Published
2019

44. Ensayos clínicos sobre dolor neuropático: factores asociados con disminuciones en la eficacia estimada del fármaco

Author

Finnerupa, Nanna B., primary, Haroutounian, Simon, additional, Baron, Ralf, additional, Dworkin, Robert H., additional, Gilron, Ian, additional, Haanpaa, Maija, additional, Jensen, Troels S., additional, Kamerman, Peter R., additional, McNicol, Ewan, additional, Moore, Andrew, additional, Raja, Srinivasa N., additional, Andersen, Niels T., additional, Sena, Emily S., additional, Smith, Blair H., additional, Rice, Andrew S.C., additional, and Attal, Nadine, additional

Published
2019
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46. Single dose intravenous diclofenac for acute postoperative pain in adults

Author

Ferguson, McKenzie C, Schumann, Roman, and McNicol, Ewan D

Subjects
Medicine General & Introductory Medical Sciences, 03 medical and health sciences, 0302 clinical medicine, Pharmacology (medical), 030212 general & internal medicine, 030217 neurology & neurosurgery
Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the analgesic efficacy and adverse effects of a single dose of intravenous diclofenac, compared with placebo or an active comparator, for moderate to severe postoperative pain in adults.

Published
2017

50. Oral paracetamol (acetaminophen) for cancer pain

Author

Wiffen, Philip J, primary, Derry, Sheena, additional, Moore, R Andrew, additional, McNicol, Ewan D, additional, Bell, Rae Frances, additional, Carr, Daniel B, additional, McIntyre, Mairead, additional, and Wee, Bee, additional

Published
2017
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