Final Research Report
View this project's final research report.
Article Highlight: Each year, more than 300,000 adults in the United States break a hip and nearly all will need surgery. This study, which compared how general anesthesia and spinal anesthesia during hip fracture surgery affected recovery, found patients who received spinal anesthesia received fewer opioids in the operating room but had more pain and prescription pain medication use after surgery. These results were published in the Annals of Internal Medicine. Overall, patients with spinal anesthesia had slightly higher levels of pain (7.9 out of 10) compared to those who had general anesthesia (7.6). Further results showed spinal anesthesia patients were also 33 percent more likely than general anesthesia patients to still be taking prescription painkillers roughly two months out from their procedure.
Results of This Project
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Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
In general, the reviewers responded positively to this report and praised the researchers for their careful approach to the study. Most of the requests for changes were minor.
The reviewers questioned the use of a composite outcome measure made up of two very different clinical outcomes: death or inability to walk after two months. The researchers explained that they included death in their composite outcome because, given the population, they wanted to avoid survivorship bias by only including patients who would have final outcome data.
The reviewers asked the researchers to explain why they adjusted their study sample into groups by hospital, sex and fracture location when the study sample was randomized so there should not have been an imbalance between groups. The researchers stated that they were following best practices for trials using stratified randomization. They also noted that although they were able to stratify groups by sex and fracture location, some hospital sites had such low enrollment that they chose to stratify by country of enrollment instead.
The reviewers noted that some subgroups of individuals with hip fracture, such as people who could not walk on their own before surgery, were excluded from the study but may be the most vulnerable to negative outcomes based on anesthesia choice. The researchers acknowledged that the exclusion of these individuals was a limitation of the study, but also noted that only three percent of the overall patient population from which they recruited was non-ambulatory pre-surgery. The researchers also acknowledged that there was a smaller percentage of people with dementia in this study than in the national population of adults with hip fractures. They posited that people with dementia were less likely to agree to the study or less likely to complete study materials, so the study results may not be generalizable to that group.
Conflict of Interest Disclosures
- Has Results