Generating Relevant Information from Patients in the Technology-Enhanced Era of Patient-Focused Drug Development: Opportunities and Challenges

Reaney, Matthew; Cline, Jennifer; Wilson, J. C.; Posey, Michael C.

doi:10.1007/s40271-020-00455-2

Cited by 2 publications

(4 citation statements)

References 14 publications

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“…These devices can unlock even greater potential when combined with medical devices or active data collection methods to fully understand patients’ experiences with a disease and/or treatment. However, ethical constraints, such as collection of sensitive data and GDPR, may present challenges that need to be overcome ( 91 ).…”

Section: Challenges and Opportunitiesmentioning

confidence: 99%

Leveraging patient experience data to guide medicines development, regulation, access decisions and clinical care in the EU

Almeida,

Umuhire,

Gonzalez-Quevedo

et al. 2024

Front. Med.

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Patient experience data (PED), provided by patients/their carers without interpretation by clinicians, directly capture what matters more to patients on their medical condition, treatment and impact of healthcare. PED can be collected through different methodologies and these need to be robust and validated for its intended use. Medicine regulators are increasingly encouraging stakeholders to generate, collect and submit PED to support both scientific advice in development programs and regulatory decisions on the approval and use of these medicines. This article reviews the existing definitions and types of PED and demonstrate the potential for use in different settings of medicines’ life cycle, focusing on Patient-Reported Outcomes (PRO) and Patient Preferences (PP). Furthermore, it addresses some challenges and opportunities, alluding to important regulatory guidance that has been published, methodological aspects and digitalization, highlighting the lack of guidance as a key hurdle to achieve more systematic inclusion of PED in regulatory submissions. In addition, the article discusses opportunities at European and global level that could be implemented to leverage PED use. New digital tools that allow patients to collect PED in real time could also contribute to these advances, but it is equally important not to overlook the challenges they entail. The numerous and relevant initiatives being developed by various stakeholders in this field, including regulators, show their confidence in PED’s value and create an ideal moment to address challenges and consolidate PED use across medicines’ life cycle.

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Section: Challenges and Opportunitiesmentioning

confidence: 99%

Leveraging patient experience data to guide medicines development, regulation, access decisions and clinical care in the EU

Almeida,

Umuhire,

Gonzalez-Quevedo

et al. 2024

Front. Med.

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show abstract

Section: Introductionmentioning

confidence: 99%

“…In consequence, attempts have been made to develop indicators (other than clinical results) that can allow healthcare managers to incorporate the patient's perspective; thus, patient‐reported outcome measures (PROMs) and patient‐reported experience measures (PREMs) have been introduced. While PROMs are more advanced and are supported by scientifically validated questionnaires, the development of PREMs lags behind and faces challenges such as the difficulty of collecting data on individuals' subjective experiences 4 …”

Section: Introductionmentioning

confidence: 99%

“…While PROMs are more advanced and are supported by scientifically validated questionnaires, the development of PREMs lags behind and faces challenges such as the difficulty of collecting data on individuals' subjective experiences. 4 Healthcare providers seek to achieve high levels of patient satisfaction, 5 one of the most frequently applied healthcare quality indicators. However, although satisfaction is a widely employed concept, there is no consensus on its nature, or on its evaluation.…”

Section: Introductionmentioning

confidence: 99%

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Incorporation of the emotional indicators of the patient journey into healthcare organization management

Rodríguez-Fuertes

Reinares-Lara

García-Henche

2022

Health Expectations

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Background In recent years, attempts have been made to incorporate patients' experiences into healthcare processes, to complement clinical indicators, with what are known as patient‐reported outcome measures (PROMs) and patient‐reported experience measures (PREMs). While the research into PROMs is more developed, the application of PREMs faces some difficulties. The incorporation of emotional indicators into assessments of the experience is an area that remains to be explored. Objectives This study proposes a new technique to analyse the emotions experienced by patients during the care process, examines how these emotions influence their satisfaction and propose that if healthcare services focus more on patients' emotions, they can improve the effectiveness of the sector. Methods The first, qualitative stage, gathered data from patients to design a patient journey (PJ). The PJ was then reproduced as a video. In a subsequent, quantitative stage, the video was shown to experimental participants, and their emotions were measured through facial expression analysis and a questionnaire. Results A new technique to gather emotional data showed that the emotions patients experience do not affect their satisfaction with their clinical care or the physical aspects of the process. However, their emotions did affect their satisfaction with people and organizations. Conclusions The importance of the emotional component of patients' experiences was underlined. Therefore, healthcare organizations should take account of this dimension, as well as the cognitive, to increase patient satisfaction and improve their care processes. Understanding the impact of the emotions identified at the subconscious level can help improve the patient experience. A new methodology was applied that may help health professionals to collect emotional data about patients' experiences and to develop PREMs. Patient/Public Contribution Patients were involved in all stages of this research. In the exploratory phase, some helped define the touchpoints of the PJ. The data from the subsequent experimental phase were collected from another group, and the emotions they experienced were identified through the analysis of their facial expressions. Based on the results of this study, a working group including patients has been established to work on improvements in the PJ.

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Generating Relevant Information from Patients in the Technology-Enhanced Era of Patient-Focused Drug Development: Opportunities and Challenges

Cited by 2 publications

References 14 publications

Leveraging patient experience data to guide medicines development, regulation, access decisions and clinical care in the EU

Leveraging patient experience data to guide medicines development, regulation, access decisions and clinical care in the EU

Incorporation of the emotional indicators of the patient journey into healthcare organization management

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