Case from a Patient Organisation (“Organisation”)
Provide data on unmet need and therapeutic burden of patient and care partner through participatory techniques, pathway mapping, life impact and emotional journey across disease states.
The assessment of the quality of PE project
The methodology of the PE practice:
- Qualitative semi-structured interviews utilizing a conversational, narrative, ethnographic approach to allow patients and care partners to piece together and share their stories and unmet needs in a meaningful way.
- Participatory techniques providing opportunity for co-production of patient/care partner pathway mapping. Example domains include:
- Emotional journey
- Impact of condition on main aspects of life
- Challenges and barriers faced
- Triggers and behaviors
- Therapeutic burden
- Relationship with healthcare team
- Decision points and clinical trial experience
1- Shared purpose
The initiative was created to ensure that patients and caregivers have an opportunity to voice unmet needs and therapeutic burden outside of specific interview style opportunity. Pathway mapping was conducted utilizing 1:1 (patient), 1:2 (patient:caregiver) and 1:many (group of patients) approaches.
Group and 1:1 feedback was obtained from patients and caregivers to ensure they felt their specific needs were being addressed.
2- Respect and accessibility
All patients and caregivers received coaching during this [project] to ensure they were comfortable interacting with various stakeholders. In addition, they created a process to provide patients, who were not comfortable participating in a group setting and those with limited mobility, to also participate. Patients were compensated for their time.
Benchmarking of fair market reimbursement was conducted. Frequent 1:1 touchpoints.
3- Representativeness of stakeholders
Different age groups, stages of disease, ethnicities and geographies were incorporated into the selection of Organisation’s patient/caregiver partners using Organisation’s database, which consists of ~17,000 patients and caregivers representing various patient and caregiver segments across disease states.
This PE project owners used documentation of demographics (to ensure fair balanced) and virtual opportunity to check if what they did was appropriate to achieve this criterion.
4- Roles and responsibilities
Patients and caregivers were clear on their role in patient pathway mapping and how the data would be used to determine trends in unmet need. Patients and caregivers were also provided direction on how their participation [in this project] would be used with feedback loops built in throughout.
Commitment documents were developed with patients and caregivers. A co-designed scorecard was used during the assessment.
5- Capacity and capability for engagement
All patients and caregivers received coaching during this [project] to ensure they were comfortable interacting with various stakeholders. Not all patients/caregivers that were interviewed were used in [this project], thus comfort level and boundaries were determined in advance.
Each patient/caregiver completed an assessment on their engagement preferences.
6- Transparency in communication and documentation
Some interviews were recorded and notes taken throughout. Feedback was captured in [the project’s] scorecards.
This PE project owners used co-designed scorecard to check if what they did was appropriate to achieve this criterion.
7- Continuity and sustainability
All patients and caregivers that participated were kept abreast of development and continuous improvement of the initiative through electronic updates, even as Organisation rotated other patients and caregivers through the project.
This PE project owners used various communication channels to check if what they did was appropriate to achieve this criterion.
PE practice led to the following (measured) outcomes:
- 1,800 patients/1,200 caregivers
- Short term and long term unmet needs were identified
- Trends in burden of therapy were identified
- Co-design of potential research questions
- Patient/caregiver unmet needs-traditionally from KOL perspective
- 5 innovations evaluated during [this project] utilizing 300 patients and caregivers
Improvement in understanding unmet needs and therapeutic burden.
Evolution from KOL perspective of patient/caregiver burden.
Positive impact for specific medicines development phases:
- Co-design of research question
- Opportunity for non-traditional voices to be heard
- Quantified patient stories through various tools
Direct or indirect positive impact for patients:
- Opportunity for patients and caregiver perspectives to be heard and dimensions of life affected to be measured
- Opportunity to understand how others are also affected through simplified comparative data reports
Direct or indirect positive impact for stakeholders involved in the project (other than patients):
- Informed understanding from patient/caregiver perspective
- Validation against EBM