Abstract
Objective: This study evaluated the sample diversity of hip fracture clinical trials conducted in the United States (US) to assess deficiencies in current research practices.
Background: Hip fractures represent a major health concern for many patients. Clinical trials are essential for guiding clinical practices for the care of these traumatic injuries. It is important to address the demographic makeup of trial participants to assure that they match the diversity of the population.
Methods: This study was a systematic review and meta-analysis of hip fracture clinical trials conducted in the US between 2018-2023. After generating a search string for these trials, the medical databases Embase (Elsevier) and Medline (PubMed) were used to identify published clinical trials concerning the treatment and management of hip fractures. The results of this search were screened in a masked, duplicate manner. Clinical trials met inclusion criteria if they were conducted at sites in the US, and involved an intervention pertaining to hip fracture. Data were extracted from these trials in a masked, duplicate fashion. Next, a preexisting framework for rating diversity in clinical trials and participation-to-disease representation ratio (PDRR) was calculated. Using PDRR we were able to assign each study a rating of ‘good’, ‘poor’, or ‘fair’ to describe the diversity of participants in the clinical trial.
Results: Of the initial 650 studies returned by our search, 12 met our inclusion criteria. Our study found that clinical trials for hip fractures in the US exhibit significant underrepresentation of key demographics, with 92% of trials rated as poor for race/ethnicity diversity, 75% rated as poor for age diversity, and 25% rated as poor for sex diversity. Of the trials we reviewed, 67% were conducted at a single site.
Conclusions: Our study highlights gaps in representation with regards to the sex, age, and ethnicity in hip fracture trials. Lack of multi-center trials as well as limited demographics of trial locations diminishes the generalizability of current published hip fracture research. Diversifying hip fracture research to reflect the disease population is essential for improving real-world patient outcomes.
Background: Hip fractures represent a major health concern for many patients. Clinical trials are essential for guiding clinical practices for the care of these traumatic injuries. It is important to address the demographic makeup of trial participants to assure that they match the diversity of the population.
Methods: This study was a systematic review and meta-analysis of hip fracture clinical trials conducted in the US between 2018-2023. After generating a search string for these trials, the medical databases Embase (Elsevier) and Medline (PubMed) were used to identify published clinical trials concerning the treatment and management of hip fractures. The results of this search were screened in a masked, duplicate manner. Clinical trials met inclusion criteria if they were conducted at sites in the US, and involved an intervention pertaining to hip fracture. Data were extracted from these trials in a masked, duplicate fashion. Next, a preexisting framework for rating diversity in clinical trials and participation-to-disease representation ratio (PDRR) was calculated. Using PDRR we were able to assign each study a rating of ‘good’, ‘poor’, or ‘fair’ to describe the diversity of participants in the clinical trial.
Results: Of the initial 650 studies returned by our search, 12 met our inclusion criteria. Our study found that clinical trials for hip fractures in the US exhibit significant underrepresentation of key demographics, with 92% of trials rated as poor for race/ethnicity diversity, 75% rated as poor for age diversity, and 25% rated as poor for sex diversity. Of the trials we reviewed, 67% were conducted at a single site.
Conclusions: Our study highlights gaps in representation with regards to the sex, age, and ethnicity in hip fracture trials. Lack of multi-center trials as well as limited demographics of trial locations diminishes the generalizability of current published hip fracture research. Diversifying hip fracture research to reflect the disease population is essential for improving real-world patient outcomes.
Original language | American English |
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Pages | 38 |
State | Published - 13 Sep 2024 |
Event | Symposium on Tribal and Rural Innovation in Disparities and Equity for Health - Tahlequah, United States Duration: 13 Sep 2024 → 13 Sep 2024 |
Conference
Conference | Symposium on Tribal and Rural Innovation in Disparities and Equity for Health |
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Country/Territory | United States |
City | Tahlequah |
Period | 13/09/24 → 13/09/24 |