“There is nothing better than participating in this study”: Living the PAPAartis cardiovascular randomised controlled trial

Contemporary Clinical Trials Communications, 2022 · DOI: https://doi.org/10.1016/j.conctc.2022.100987 · Published: September 3, 2022

Patient Experience Research Methodology & Design

Simple Explanation

This study explores the experiences of patients participating in the PAPAartis randomized clinical trial, which aims to prevent spinal cord injuries during surgery for thoracoabdominal aneurysm. The research involved in-depth interviews with 16 patients to understand their decision-making process and overall experience. The study found that patients participate in the trial for various reasons, including trust in doctors, hope for better treatment, and altruistic reasons. However, many patients felt they did not fully comprehend the information provided about the study and the complex procedure. Avoidance of paraplegia was a major factor in the decision to participate. Family support and socioeconomic conditions also influenced the recovery process after surgery. The COVID-19 pandemic also added complexities to the treatment and recovery.

Study Duration

Not specified

Participants

16 patients participating in the PAPAartis trial

Evidence Level

Qualitative study embedded in a Randomized Controlled Trial

Key Findings

1
Patients participate in clinical trials due to trust in doctors, hope for better treatment, and altruistic motives, but often struggle to understand the complex information provided.
2
The fear of paraplegia is a significant motivator for patients to participate in the PAPAartis trial, influencing their decision-making process.
3
Family support and socioeconomic conditions significantly impact the recovery process of patients undergoing treatment for thoracoabdominal aortic aneurysms.

Research Summary

This qualitative study investigated the experiences of patients participating in the PAPAartis clinical trial, which aims to prevent spinal cord injuries during thoracoabdominal aortic aneurysm repair. In-depth interviews with 16 patients revealed diverse motivations for participation, including trust in clinicians, hope for improved treatment outcomes, and altruistic contributions to scientific advancement. The study highlighted the critical role of paraplegia avoidance in patient decision-making, with many participants prioritizing the reduction of spinal cord injury risk. Family support, socioeconomic factors, and the impact of the COVID-19 pandemic were also identified as significant influences on the recovery process. The findings underscore the importance of clear and tailored communication in clinical trials, addressing patients' concerns and ensuring informed consent. The study also emphasizes the need to consider the broader social context of patients, including family dynamics and access to resources, to optimize treatment and recovery outcomes.

Practical Implications

Improved Patient Communication

Clinical trial information should be simplified and tailored to patients' needs to ensure better understanding and informed consent.

Holistic Patient Care

Healthcare providers should consider patients' socioeconomic conditions and family support systems when planning treatment and recovery strategies.

Address Fear of Paraplegia

Clinicians should directly address the fear of paraplegia in patients considering TAAA repair and explain the potential benefits of new interventions.

Study Limitations

1
The study focuses on a small sample of patients from German sites, limiting the generalizability of the findings.
2
The study lacks data from patients who declined to participate in the trial, potentially skewing the understanding of motivations and barriers.
3
The shift to telephone interviews due to the COVID-19 pandemic may have impacted the depth and richness of the qualitative data collected.

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