Acute pain pathways: protocol for a prospective cohort study
Introduction Opioid analgesics are often used to treat moderate-to-severe acute non-cancer pain; however, there is little high-quality evidence to guide clinician prescribing. An essential element to developing evidence-based guidelines is a better understanding of pain management and pain control a...
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BMJ Publishing Group
2022-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/7/e058782.full |
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| author | Christine Lee Joseph S Ross Molly Moore Jeffery Nilay D Shah David B Page Nancy Chang Fernanda Bellolio Sam Torbati Jessica D Ritchie Gregg H Gilbert Lindsay Emanuel Mitra Ahadpour Summer Allen Richardae Araojo Laura Ciaccio Jonathan Fillmore Patricia Koussis Heather Lipkind Celeste Mallama Tamra Meyer Megan Moncur Teryl Nuckols Michael A Pacanowski Elektra Papadopoulos Mat Soukup Christopher O St. Clair Stephen Tamang Douglas W Wallace Yueqin Zhao Rebekah Heckmann |
| author_facet | Christine Lee Joseph S Ross Molly Moore Jeffery Nilay D Shah David B Page Nancy Chang Fernanda Bellolio Sam Torbati Jessica D Ritchie Gregg H Gilbert Lindsay Emanuel Mitra Ahadpour Summer Allen Richardae Araojo Laura Ciaccio Jonathan Fillmore Patricia Koussis Heather Lipkind Celeste Mallama Tamra Meyer Megan Moncur Teryl Nuckols Michael A Pacanowski Elektra Papadopoulos Mat Soukup Christopher O St. Clair Stephen Tamang Douglas W Wallace Yueqin Zhao Rebekah Heckmann |
| author_sort | Christine Lee |
| collection | DOAJ |
| description | Introduction Opioid analgesics are often used to treat moderate-to-severe acute non-cancer pain; however, there is little high-quality evidence to guide clinician prescribing. An essential element to developing evidence-based guidelines is a better understanding of pain management and pain control among individuals experiencing acute pain for various common diagnoses.Methods and analysis This multicentre prospective observational study will recruit 1550 opioid-naïve participants with acute pain seen in diverse clinical settings including primary/urgent care, emergency departments and dental clinics. Participants will be followed for 6 months with the aid of a patient-centred health data aggregating platform that consolidates data from study questionnaires, electronic health record data on healthcare services received, prescription fill data from pharmacies, and activity and sleep data from a Fitbit activity tracker. Participants will be enrolled to represent diverse races and ethnicities and pain conditions, as well as geographical diversity. Data analysis will focus on assessing patients’ patterns of pain and opioid analgesic use, along with other pain treatments; associations between patient and condition characteristics and patient-centred outcomes including resolution of pain, satisfaction with care and long-term use of opioid analgesics; and descriptive analyses of patient management of leftover opioids.Ethics and dissemination This study has received approval from IRBs at each site. Results will be made available to participants, funders, the research community and the public.Trial registration number NCT04509115. |
| format | Article |
| id | doaj-art-ac2ab0b35e6d4d258418cef239bf7638 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-ac2ab0b35e6d4d258418cef239bf76382025-01-31T01:15:09ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2021-058782Acute pain pathways: protocol for a prospective cohort studyChristine Lee0Joseph S Ross1Molly Moore Jeffery2Nilay D Shah3David B Page4Nancy Chang5Fernanda Bellolio6Sam Torbati7Jessica D Ritchie8Gregg H Gilbert9Lindsay Emanuel10Mitra Ahadpour11Summer Allen12Richardae Araojo13Laura Ciaccio14Jonathan Fillmore15Patricia Koussis16Heather Lipkind17Celeste Mallama18Tamra Meyer19Megan Moncur20Teryl Nuckols21Michael A Pacanowski22Elektra Papadopoulos23Mat Soukup24Christopher O St. Clair25Stephen Tamang26Douglas W Wallace27Yueqin Zhao28Rebekah Heckmann29Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, CanadaDepartment of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USADivision of Health Care Delivery Research, Mayo Clinic, Rochester, Minnesota, USAHealth Sciences Research, Mayo Clinic, Rochester, Minnesota, USA4Robert W. Franz Cancer Center, Providence Cancer Institute, Portland, OR, USACenter for Drug Evaluation and Research, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland, USAEmergency Medicine and Health Care Delivery Research, Mayo Clinic, Rochester, Minnesota, USADepartment of Emergency Medicine, Cedars-Sinai Medical Center, Los Angeles, California, USAYale-New Haven Center for Outcomes Research and Evaluation (CORE), Yale School of Medicine, New Haven, Connecticut, USADepartment of Clinical and Community Sciences, School of Dentistry, The University of Alabama at Birmingham School of Dentistry, Birmingham, Alabama, USADivision of Health Care Delivery Research, Kern Center for the Science of Health Care Delivery, Mayo Clinic Rochester, Rochester, Minnesota, USACenter for Drug Evaluation and Research, Office of Surveillance and Epidemiology, US Food and Drug Administration, Silver Spring, Maryland, USAKnowledge and Evaluation Research Unit; Department of Family Medicine, Mayo Clinic Rochester, Rochester, Minnesota, USAOffice of the Commissioner, Office of Minority Health and Health Equity, US Food and Drug Administration, Silver Spring, Maryland, USADivision of Population Health and Genomics, University of Dundee School of Medicine, Dundee, UKDepartment of Surgery, Mayo Clinic Division of Oral and Maxillofacial Surgery, Rochester, Minnesota, USACenter for Drug Evaluation and Research, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland, USADepartment of Obstetrics, Gynecology, & Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut, USACenter for Drug Evaluation and Research, Office of Surveillance and Epidemiology, US Food and Drug Administration, Silver Spring, Maryland, USACenter for Drug Evaluation and Research, Office of Surveillance and Epidemiology, US Food and Drug Administration, Silver Spring, Maryland, USACenter for Drug Evaluation and Research, Office of New Drugs, US Food and Drug Administration, Silver Spring, Maryland, USADivision of General Internal Medicine, Cedars-Sinai Medical Center, Los Angeles, California, USACenter for Drug Evaluation and Research, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland, USACenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USACenter for Drug Evaluation and Research, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland, USACenter for Drug Evaluation and Research, Office of New Drugs, US Food and Drug Administration, Silver Spring, Maryland, USADepartment of Family Medicine, Monument Health, Rapid City, South Dakota, USADepartment of Emergency Medicine, Department of Medicine, Division of Pulmonary, Allergy & Critical Care Medicine, The University of Alabama, Birmingham, Alabama, USACenter for Drug Evaluation and Research, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland, USADepartment of Emergency Medicine, Yale University, New Haven, Connecticut, USAIntroduction Opioid analgesics are often used to treat moderate-to-severe acute non-cancer pain; however, there is little high-quality evidence to guide clinician prescribing. An essential element to developing evidence-based guidelines is a better understanding of pain management and pain control among individuals experiencing acute pain for various common diagnoses.Methods and analysis This multicentre prospective observational study will recruit 1550 opioid-naïve participants with acute pain seen in diverse clinical settings including primary/urgent care, emergency departments and dental clinics. Participants will be followed for 6 months with the aid of a patient-centred health data aggregating platform that consolidates data from study questionnaires, electronic health record data on healthcare services received, prescription fill data from pharmacies, and activity and sleep data from a Fitbit activity tracker. Participants will be enrolled to represent diverse races and ethnicities and pain conditions, as well as geographical diversity. Data analysis will focus on assessing patients’ patterns of pain and opioid analgesic use, along with other pain treatments; associations between patient and condition characteristics and patient-centred outcomes including resolution of pain, satisfaction with care and long-term use of opioid analgesics; and descriptive analyses of patient management of leftover opioids.Ethics and dissemination This study has received approval from IRBs at each site. Results will be made available to participants, funders, the research community and the public.Trial registration number NCT04509115.https://bmjopen.bmj.com/content/12/7/e058782.full |
| spellingShingle | Christine Lee Joseph S Ross Molly Moore Jeffery Nilay D Shah David B Page Nancy Chang Fernanda Bellolio Sam Torbati Jessica D Ritchie Gregg H Gilbert Lindsay Emanuel Mitra Ahadpour Summer Allen Richardae Araojo Laura Ciaccio Jonathan Fillmore Patricia Koussis Heather Lipkind Celeste Mallama Tamra Meyer Megan Moncur Teryl Nuckols Michael A Pacanowski Elektra Papadopoulos Mat Soukup Christopher O St. Clair Stephen Tamang Douglas W Wallace Yueqin Zhao Rebekah Heckmann Acute pain pathways: protocol for a prospective cohort study BMJ Open |
| title | Acute pain pathways: protocol for a prospective cohort study |
| title_full | Acute pain pathways: protocol for a prospective cohort study |
| title_fullStr | Acute pain pathways: protocol for a prospective cohort study |
| title_full_unstemmed | Acute pain pathways: protocol for a prospective cohort study |
| title_short | Acute pain pathways: protocol for a prospective cohort study |
| title_sort | acute pain pathways protocol for a prospective cohort study |
| url | https://bmjopen.bmj.com/content/12/7/e058782.full |
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