The PARADIGM patient engagement toolbox: Measuring ‘improved quality of evidence generation’

Building on our recent posts related to the PARADIGM Patient Engagement Monitoring and Evaluation Framework, which aims to foster an innovative approach to measuring the success of patient centricity and engagement in healthcare, this article examines its third key objective: measuring improvements in the quality of evidence generation.

Ensuring high-quality evidence is crucial in the pharmaceutical industry, yet quantifying it can be challenging due to the complexities of clinical research. The evidence hierarchy serves as a valuable framework to grade the ‘best’ available evidence based on study design, such as systematic reviews or randomised controlled trials. (1) However, the strength of scientific evidence also relies on several additional factors, including the accuracy of data collection, the transparency and reproducibility of methods, and adherence to ethical standards. (2,3)

Fortunately, the PARADIGM patient engagement monitoring and evaluation framework provides a comprehensive approach to assess the quality of evidence generation, placing the patient at the centre. Some of the learning and change metrics utilised to determine the short-term effects of patient engagement activities on the quality of scientific evidence include: (4)

• The influence of patients' insights on research decision-making
• Changes in awareness and knowledge about patients' needs
• The number and type of patient recommendations implemented in clinical research

In the longer term, the PARADIGM monitoring and evaluation framework employs various impact metrics to assess how patient insights influence the quality of evidence generation across clinical settings. Examples of these include: (4)

• The quality of scientific advice provided by regulatory bodies
• The percentage of studies with patient-reported outcomes
• The number of clinical trials including historically marginalised patient populations, or in other words, diversity

Furthermore, the patient engagement toolbox proposes various methods for measuring these metrics, incorporating both quantitative and qualitative approaches. For instance, evaluating changes in research decision-making might necessitate that researchers respond to open-ended survey questions, such as "Can you recall a specific instance when patient feedback alerted you to a design flaw in your study?” In contrast, the number of trials advocating for the inclusion of underrepresented groups would likely be quantified using numbers and percentages. (4)

At Synthesis, we advocate for scientifically robust, representative, and ethically sound research that aims to deliver better health outcomes for all. Contact us at [email protected] to explore how our team of specialist medical writers can support you in creating personalised innovative solutions from evidence-based patient insights.

References:

1. How to Determine The Strength Of Evidence in Research https://nutriadmin.com/blog/how-to-determine-the-strength-of-evidence-in-research/
2. Guyatt GH, Oxman AD, Kunz R, et al. What is "quality of evidence" and why is it important to clinicians?. BMJ. 2008;336(7651):995-998. doi:10.1136/bmj.39490.551019.BE
3. What Is Ethics in Research & Why Is It Important? https://www.niehs.nih.gov/research/resources/bioethics/whatis
4. Vat LE, Finlay T, Robinson P, et al. Evaluation of patient engagement in medicine development: A multi-stakeholder framework with metrics. Health Expect. 2021;24(2):491-506. doi:10.1111/hex.13191. Appendix S2: Patient Engagement Monitoring and Evaluation Framework