Guidelines for the management of acute low back pain
Active Cooperative Agreement Awarded Last action
- Award ID
- U01FD008148
- Recipient
-
Oregon Health & Science University UEI NPSNT86JKN51
- Awarding agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Obligated
- $1,999,980
Award facts
- Assistance listing
- 93.103 Food and Drug Administration Research
- Completion date 77% complete
- Originally
- Funding agency
- Center for Drug Evaluation and Research Food and Drug Administration, Department of Health and Human Services
- Place of performance
- Oregon, USA
Award details come from USAspending.gov.
Description
- Abstract
- The world health organization (who) recently reported that low back pain (LBP) is the leading cause of disability globally; among musculoskeletal conditions LBP accounts for the highest prevalence. One estimate indicates that at some point in their lives, up to 84% of adults will suffer from LBP. Although most patients with acute low back pain (albp) experience rapid improvement, some patients develop persistent, disabling symptoms. Management of albp has been characterized by variability in use of imaging and treatments, including frequent use of opioids. While clinical practice guidelines (cpgs) recommend judicious use of opioids, overprescribing remains an important area of concern, including serious adverse events such as overdose and opioid use disorder. In 2017, an estimated 47,600 americans died from opioid overdose; 17,000 from prescription opioids. Given the high prevalence of albp and the potential to improve health outcomes through evidence-based approaches to evaluation and management, the U.S. Food and drug administration (FDA) identified the development of cpgs for treatment of albp as a priority. The objective of this proposal is to assemble a highly experienced, multidisciplinary team of clinical investigators, methodologists, providers, healthcare systems, payers, and patient representatives to conduct a rigorous systematic review (SR) of the literature about management of albp; derive evidence-based clinical practice guidelines (cpgs); conduct a wide-ranging dissemination and implementation campaign; and evaluate the impact of the cpgs on knowledge, uptake, prescribing behavior, and short-term outcomes. Our specific aims are: specific aim #1. [phase 1A] following rigorous, accepted methodology for transparency and objectivity, conduct an evidence-based systematic review of the literature on the evaluation and management of albp, including the benefits and harms of use of opioids. Specific aim #2. [phase 1B] utilizing the SR, develop an evidence-based CPG using a transparent process. Specific aim #3. [phase 2] disseminate and implement the CPG, through implementation tools; publications and presentations to conferences, specialty societies, healthcare systems, payers, and patient/advocacy groups; and through webinars, social media posts, podcasts, a provider APP, and a patient journey map. Specific aim #4. [phase 3] evaluate the impact of the CPG on adoption, and on changes in knowledge, pain management, prescribing practices, and measures of utilization. Describe and analyze barriers to and facilitators of CPG implementation. In accomplishing these aims, we will produce a CPG for management of albp that will contribute to the goals of the FDA to provide indication-specific, appropriate prescribing information for pharmacologic and non- pharmacologic treatments to the provider communities, while reducing opioid misuse and abuse. We will establish and document rigorous and reproducible dissemination and implementation protocols and practices that can be used for future CPG projects.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Amendment | $0 | |
| Original award | $1,999,980 |
Subawards
| Subrecipient | Amount | Awarded |
|---|---|---|
| Subrecipient not on record | $531,568 | |
| Aggregate Analytics Inc. | $437,837 |
Quick answers
Who received award U01FD008148?
U01FD008148 was awarded to Oregon Health & Science University by FDA Office of Acquisition and Grant Services (Food and Drug Administration) on September 25, 2023.
How much is award U01FD008148 worth?
$1,999,980 has been obligated on U01FD008148.
Which agency awarded U01FD008148?
FDA Office of Acquisition and Grant Services (Food and Drug Administration) awarded U01FD008148, with funding from Center for Drug Evaluation and Research (Food and Drug Administration).
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