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Clinical Trial: A Case Study in Design, Execution, and Dissemination

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Clinical Trial: A Case Study in Design, Execution, and Dissemination

Patient and public engagement (PPI) in health research is gaining popularity, and positive

psychology and subjective wellbeing are two reasons why. However, PPI has little experience

and expertise in all stages of the research process, notably analysis. I discussed how to include

patients' viewpoints in the study process, as well as the benefits and difficulties of our

partnership. We provide a nested treatment fidelity study and a single-case exploratory analysis

of a randomized controlled trial of a therapeutic intervention. The experiment that examined the

effectiveness of employing patient-reported outcome (PRO)-measures as a conversation tool in

the patient-physician consultation was designed, implemented, and disseminated with the

participation of five patient representatives with metastatic disease. Following instruction in the

Verona Coding Definitions of Emotional Sequences, audio recordings of consultations were


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examined for fidelity in the study (VR-CoDES). Collective results were presented in a global

scientific meeting. A workshop was held to discuss the results, effects, and difficulties.

I chose PRO-measures and verified the conversational aid during the design process.

Following the feedback of the patients, the report was revised. According to the results of the

fidelity study, there was broad agreement between patients and researchers on the categorization

of their emotions and their main worries. As well as validating the findings, the patients added to

the conversation by providing fresh vocabulary and insights. Emotional (grief/sorrow, existential

questions), organizational (scheduling meetings, striking a work-life balance), and mental

(avoiding information damage, carrying on despite patients' deaths) issues were all prompted by

PPI. The absence of a thorough evaluation method for PPI's effects was a drawback of the study.

Incorporating PPI at all stages and encouraging collaborative analysis was not only doable, but

also highly useful. The level of practical details, longevity, and openness in this scenario makes

it stand out. In addition, the process of co-creation yields insights about how PPI may be put into

practice. Emotional, administrative, and intellectual investments were all taken into account at an

evaluation session, revealing what may be called "tacit but vital work." We can take what we've

learned and use it in future trials where patients are active participants.

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