Abstract
Objective: To examine the uptake of recommended outcomes within stroke clinical trials, as outlined by the International Consortium for Health Outcomes Measurement (ICHOM).
Background: Considering the diverse backgrounds of stroke researchers throughout the globe, it is unsurprising that stroke clinical trials often report different outcomes.To address this heterogeneity in outcomes, core outcome sets (COS) have been developed that are specific to numerous medical fields. Containing recommendations for minimum standardized outcomes, COS aims to increase efficiency, reproducibility, and transparency in clinical trial results. The first patient-centered COS for stroke clinical trials was published by Salinas et al. in 2016. Therefore it is the aim of our study to measure the adoption of patient-centered outcomes as recommended by Salinas et al. in stroke clinical trials in the years since its inception.
Methods: A stroke-specific COS was identified by searching the COMET database. Stroke clinical trials from between 1/1/1991 and 6/26/2023 were pulled from ClinicalTrials.gov. A total of 93 studies were included in our final sample after applying the inclusion criteria described by Salinas et al. In a blind, duplicate fashion, two researchers (WC, PC) extracted outcomes for each included study from ClinicalTrials.gov database, an electronic clinical trial registry. The presence of an outcome was recorded as "yes" or "no" along with other trial characteristics such as phase, region of registry, before/after publication of COS, recruitment status, and type of intervention.
Results: were then analyzed via RStudio. Results The most reported outcomes across 93 included stroke clinical trials were "Ability to return to usual activities" (97.8%), "Mobility" (96.8%), and "Survival" (91.4%). Outcomes mentioned the least were "Adherence to smoking cessation advice" (0.0%), "Feeding" (0.0%), and "Fatigue" (1.1%). Overall 9-of-12 solely patient-reported outcomes were mentioned by less than half of clinical trialists.
Conclusion: Patient-reported outcomes (PROs) were reported at lower rates than outcomes involving clinician-reported sources, throughout our sample. The publication of Salinas et al. did not have a significant impact on the uptake of recommended outcomes. Because of the benefit of PROs, we recommend increased reporting of PROs in stroke clinical trials in accordance with the patient-centered COS published by Salinas et al.
Background: Considering the diverse backgrounds of stroke researchers throughout the globe, it is unsurprising that stroke clinical trials often report different outcomes.To address this heterogeneity in outcomes, core outcome sets (COS) have been developed that are specific to numerous medical fields. Containing recommendations for minimum standardized outcomes, COS aims to increase efficiency, reproducibility, and transparency in clinical trial results. The first patient-centered COS for stroke clinical trials was published by Salinas et al. in 2016. Therefore it is the aim of our study to measure the adoption of patient-centered outcomes as recommended by Salinas et al. in stroke clinical trials in the years since its inception.
Methods: A stroke-specific COS was identified by searching the COMET database. Stroke clinical trials from between 1/1/1991 and 6/26/2023 were pulled from ClinicalTrials.gov. A total of 93 studies were included in our final sample after applying the inclusion criteria described by Salinas et al. In a blind, duplicate fashion, two researchers (WC, PC) extracted outcomes for each included study from ClinicalTrials.gov database, an electronic clinical trial registry. The presence of an outcome was recorded as "yes" or "no" along with other trial characteristics such as phase, region of registry, before/after publication of COS, recruitment status, and type of intervention.
Results: were then analyzed via RStudio. Results The most reported outcomes across 93 included stroke clinical trials were "Ability to return to usual activities" (97.8%), "Mobility" (96.8%), and "Survival" (91.4%). Outcomes mentioned the least were "Adherence to smoking cessation advice" (0.0%), "Feeding" (0.0%), and "Fatigue" (1.1%). Overall 9-of-12 solely patient-reported outcomes were mentioned by less than half of clinical trialists.
Conclusion: Patient-reported outcomes (PROs) were reported at lower rates than outcomes involving clinician-reported sources, throughout our sample. The publication of Salinas et al. did not have a significant impact on the uptake of recommended outcomes. Because of the benefit of PROs, we recommend increased reporting of PROs in stroke clinical trials in accordance with the patient-centered COS published by Salinas et al.
| Original language | American English |
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| State | Published - 21 Jul 2023 |
| Event | 7th Annual Joint Research Meeting: Biomedical, Biological, Neuroscience, Physiology, Forensics - Tandy Conference Center, Tulsa, United States Duration: 21 Jul 2023 → 21 Jul 2023 |
Conference
| Conference | 7th Annual Joint Research Meeting: Biomedical, Biological, Neuroscience, Physiology, Forensics |
|---|---|
| Abbreviated title | 7th Joint Annual Research Meeting |
| Country/Territory | United States |
| City | Tulsa |
| Period | 21/07/23 → 21/07/23 |