From patient to advisor: establishing a patient council for dry eye research

Abstract

Objective

To assess the feasibility and participant-reported perceptions of a multiphase training program that jointly prepares patients and researchers for collaboration in dry eye patient-centered research.

Design

Cross-sectional, mixed methods study. August–September 2025.

Subjects

Initial cohort: Dry eye patients/caregivers (8) and researchers (3). Age 18–75. High school to postgraduate education. Eastern and Central time zones. English fluency. Access to computer, internet. The participants were selected through purposive, snowball sampling. Eight (83%) females and 3 (27%) males were included. One female dropped out during Phase 1 and was replaced. One female dropped out after Phase 2 and was not replaced. The final cohort included 7 (70%) females and 3 (30%) males. Age > 30–75 years.

Intervention

Participants completed a structured three‑phase training program beginning with online informational modules on patient-centered research literacy, including study design and research methods; progressed to book studies with quizzes and live virtual discussions to develop in‑depth disease knowledge; and culminated in group simulations, designing a mock research study, and replicating real‑world teamwork. July 2023–June 2025.

Main outcome measures

Quantitative: participant-reported perceptions of the training using 5-point Likert scales. Qualitative: responses to semi-structured interviews.

Results

Quantitative: Statistically significant gains in self-reported knowledge were observed across all three phases of training; Wilcoxon signed-rank tests, W = -22.5, P < .01; effect sizes for each phase were large, r = .96, 0.91 and 0.91, respectively. However, results should be interpreted with caution. Qualitative: Participants described Phase 1 (Research Fundamentals) as informative but occasionally tedious; Phase 2 (Mastering Dry Eye) as valuable for in-depth content and small-group discussions; Phase 3 (Research Practicum) as valuable, although some participants expressed frustration/low interest.

Conclusions

Participants reported that this structured, multiphase training program supported their readiness for collaborative engagement in dry eye patient-centered comparative effectiveness research (CER). Statistically significant gains in self-reported knowledge were observed across all three phases, with large effect sizes. Participants valued emphasis on disease-specific education and interactive learning. Future adaptations should better support individuals with limited research experience. The findings informed the decision to establish a dry eye patient research advisory group, the Dry Eye Patient Council.

Supplementary Information

The online version contains supplementary material available at 10.1186/s40900-026-00929-x.

Plain language summary

This study examined whether a three-part training program could help dry eye patients feel prepared to work with researchers on patient-centered research. The participants were adults with dry eye disease (or caregivers) and researchers who were 18–75 years old, lived in the U.S., spoke English, and had access to a computer and the internet. Ten completed the program.

The training ran from July 2023 to June 2025 and included three phases:

• Phase 1: Research Basics. Participants completed online modules on the fundamentals of patient-centered research, including how studies are designed and conducted.

• Phase 2: Mastering Dry Eye. Participants read a book about dry eye disease, took quizzes, and joined virtual discussions to deepen their understanding of the condition.

• Phase 3: Research Simulation. Participants worked in teams to design mock research studies, gaining hands-on experience.

The study assessed self-reported perception of the training. Participants reported increases in knowledge across all three phases. Feedback about the training experience included the following:

• Phase 1 was informative but sometimes tedious.

• Phase 2 was valued for its depth and small-group discussions.

• Phase 3 was useful, but some participants felt frustrated or less engaged.

Overall, participants reported that the program supported their readiness to collaborate with researchers. Participants especially appreciated the disease-specific education and interactive learning. Future versions may need added support for those with limited research experience. These findings supported the creation of a new patient advisory group for dry eye research, the Dry Eye Patient Council.

Supplementary Information

The online version contains supplementary material available at 10.1186/s40900-026-00929-x.

Introduction

Dry eye-related research has largely ignored the patient perspective despite the profound impact that the disease and related comorbidities can have on quality of life [1]. Among hundreds of published dry eye studies, only one [2] meaningfully incorporated the patient perspective across its design, implementation, and analysis. In contrast, three studies [3–5] that appeared patient-centered positioned patients primarily as study subjects rather than as collaborators in the research process.

The absence of patient cocreation renders most dry eye research incomplete. This limitation is not solely attributable to researchers. For over 15 years, including patients as partners rather than just subjects has been a hallmark of disease-specific and community-based research initiatives [6, 7]. However, dry eye researchers have lacked access to a trained, disease-specific patient advisory body. Without such a structure, there has been no mechanism to support authentic, sustained patient engagement.

In response to this deficiency, and modeled on other advisory groups, [8–10] the Not A Dry Eye Foundation established the Dry Eye Patient Council to give patients a voice in research and researchers access to the lived experiences and priorities of patients. The project aimed to align dry eye research with broader efforts to involve patients across the research lifecycle described by various patient‑engagement frameworks [11–13]. These frameworks emphasize collaboration between stakeholders and patients throughout the research process, including priority setting, study design, data analysis, and dissemination. In these contexts, patients participate as active contributors whose lived experience enhances the relevance, credibility, and impact of the resulting evidence.

Building on these principles, the initiative brought together patients, caregivers, and researchers to participate in a two-year training program addressing both dry eye complexity and the foundational principles of patient-centered comparative effectiveness research (CER). In this cross-sectional, mixed-methods study, we examine the feasibility and participant-reported perceptions of a multi-phase training program designed to prepare patients and caregivers for participation on the advisory council.

Intervention

The effort to establish the Dry Eye Patient Council began in mid-2023 through the Not A Dry Eye Foundation (www.notadryeye.org), a nonprofit organization led by patients, funded through a two-year Patient-Centered Outcomes Research Institute (PCORI) Engagement Award [14]. The project’s purpose was to equip patients and caregivers with the skills to support meaningful participation in patient-centered research. Candidates for membership in the patient council were selected through purposive and snowball sampling on the basis of lived experience with dry eye. Researchers were also selected through purposive and snowball sampling on the basis of their research focus, e.g. clinical research on Meibomian gland dysfunction, decision support systems for healthcare.

The initial cohort included eight patients/caregivers and three researchers aged 18–75 years, with high school-to-postgraduate education, residing in two time zones (Eastern and Central), 8 (83%) of whom were female and 3 (27%) of whom were male. One female dropped out after Phase 2, leaving 7 (70%) females and 3 (30%) males in the final cohort; ages > 30–75 years. Patient-participants reported during the study interviews that they had been living with dry eye for an average of 13.2 years (range 2–40 years). All the participants were fluent in English and had access to computers, the internet, and Zoom. An Engagement Agreement outlined an estimated time commitment of approximately 40 h of participation per grant year. Participants were compensated at a rate of $50 per hour which equated to $2,000 per participant in each grant year.

All patient/caregiver-participants (n = 7) successfully completed the training and qualified to become members of the Dry Eye Patient Council. Assignments to research projects will be based on their interests, availability, and other logistical factors.

Training

The training emphasized three domains: (1) foundational patient-centered CER literacy, (2) an in-depth understanding of dry eye, and (3) practical experience in developing a dry eye-related research study. Training was delivered in three progressive phases:

• Phase 1: PCORI Research Fundamentals (Fall 2023). Self-paced modules introducing key research [15] and multistakeholder team [16] concepts.

• Phase 2: Mastering Dry Eye (spring 2024). A seven-module education series focused on the science of dry eye.

• Phase 3: Dry Eye Patient Council Practicum (spring 2025). A simulated team-based experience preparing mock dry eye-related research studies.

Phase 1: PCORI research fundamentals training

In September 2023, participants started PCORI’s online course, Research Fundamentals [15] and Building Effective Multi-Stakeholder Research Teams [16]. The self-paced courses introduced participants to core patient-centered CER concepts (see Supplemental Material 1).

Phase 2: Mastering Dry Eye

The participants engaged in a structured seven-module experience based on the authoritative text Your Dry Eye Mystery Solved: Reversing Meibomian Gland Dysfunction, Restoring Hope [17]. Quizzes were administered through TalentLMS (https://www.talentlms.com/), an online learning management system (LMS). Training materials included a 100-page study guide (see Supplemental Material 2), glossaries, videos, slide sets, and challenge questions for real-time, live, small group virtual (Zoom) discussions (see Supplemental Material 3). The instructional design and technical content were reviewed by experts.

The modules were delivered every three weeks beginning in April 2024. The curriculum emphasized the progressive layering of concepts—from basic eye anatomy to more complex topics such as pathophysiology, comorbidities, contributing factors, symptoms, diagnosis, treatment, and disease management. Each module followed a 4-step process.

1. LMS video overview

2. Assigned readings and glossary terms

3. Open-note quizzes

4. Live virtual session with review and discussions

Quizzes measured knowledge acquisition, with a passing criterion of 80% accuracy. Unlimited retakes were allowed until the criterion was met. Challenge questions required oral articulation of key concepts and terminology. The course concluded with an online oral examination conducted in front of the entire group, during which participants were required to pronounce medical terms aloud and provide their definitions. All the participants passed and advanced to the research practicum.

The pedagogical approach balanced structure with adaptability. Learners progressed at their own pace within each module window while benefiting from scheduled discussions. This blend of self-guided study and interactive facilitation prepared participants for collaborative engagement in the final phase.

Phase 3: Research practicum

Beginning in January 2025, the six-session practicum simulated a professional collaborative experience. The participants were assigned to one of three teams to codesign mock research study proposals. Each team included one researcher and several patients or caregivers.

Teams prepared contracts to set team norms and expectations, identified research topics, conducted literature reviews, and selected one topic to pursue. A patient-centered CER-aligned template guided proposal development. Teams also prepared slide presentations.

Before Session Five, proposals and slide presentations were submitted for review by a panel of PCORI Ambassador judges via a preestablished scoring rubric (see Supplemental Material 4). During their presentations, participants shared speaking responsibilities and responses to questions. Teams submitted addenda addressing judges’ questions before the final session, where judges selected the strongest proposal.

Assignments promoted methodological rigor and inclusive engagement. Participation fostered confidence and the ability to address the technical, ethical, and strategic dimensions of collaborative research.

Theoretical framework

The curriculum was intentionally structured using principles from adult learning theory [18]. Phase 1 introduced foundational concepts essential for later phases, including clinical research, patient-centered research, and comparative effectiveness research. Although the PCORI modules were not developed by our team, placing this content at the beginning of the curriculum aligns with adult learning principles and cognitive load theory, that emphasize establishing core terminology and conceptual grounding before engaging in more complex or applied tasks [19]. Phase 2 reflected adult and self-directed learning principles, as participants engaged with a variety of materials and activities—including textbook chapters, comprehension quizzes, and guided small-group discussions followed by reporting out to the larger group. These activities supported conceptual understanding, reflection, and collaborative meaning-making [18, 20]. Experiential learning theory guided the design of Phase 3, which engaged participants in a simulated collaborative practicum that required working through real-world tasks, reflecting on decisions, and iteratively refining the approach [21]. In Phases 2 and 3, the training fostered a community of practice in which patients and researchers learned collaboratively, consistent with the framework described by Lave and Wenger.

Reflexivity and governance

Grant acquisition, training design and development, and the study described here were led by the PI (first author), a dry eye patient with extensive subject-matter expertise, including co-authorship of clinical and research texts and of the book used in the Mastering Dry Eye training. This dual role shaped both the development of the multi-phase training program and the conduct of the study. The curriculum was developed by the PI in collaboration with a professional instructional designer (second author). Participating patients, caregivers, and researchers did not contribute to curriculum development, consistent with standard educational practice in which learners are not expected to design instructional content. As previously noted, clinical and instructional components were reviewed by outside experts.

We acknowledge that the instructional designer and PI who conducted the interviews also developed and delivered the training being evaluated. This dual role may have introduced a power dynamic in which participants perceived the interviewers as authority figures or evaluators of their performance. As a result, participants may have felt inclined to emphasize positive aspects of the training or to withhold criticism. We attempted to mitigate this by emphasizing confidentiality, using open-ended questions, and triangulating quantitative and qualitative findings. Nonetheless, we recognize that these relational dynamics may have shaped the data and we address this as a limitation.

The project was funded by PCORI, which had no role in curriculum development, data collection, analysis, or interpretation. Finally, we acknowledge that the PI’s dual identity as both a patient and researcher, and the instructional designer’s dual role in curriculum development and research, may introduce allegiance effects.

Methods

The study received IRB exemption. Study participants were not compensated. Approximately 4 months after training concluded, one-on-one virtual semi-structured interviews were conducted via Zoom with participants who completed the training (n = 10). The participants provided verbal consent. The items were developed in accordance with the tailored design method [22] guidelines for survey research, including procedures for conducting phone interviews. The participants were read questions aloud and shown PowerPoint slides to focus their responses (see Supplemental Materials 5 and 6). The interviews were audio recorded and transcribed via the Zoom transcription tool, deidentified except for patient or nonpatient status, and saved in Microsoft Word and Excel files.

All quantitative items were self-reported participant perceptions of the following: the value of the phase of training, the effectiveness of the training and materials provided, the quality of training and materials provided, the participant’s level of engagement, the pre- and post-training level of knowledge, degree of meeting participant’s personal objectives, level of compensation, and likelihood to recommend training. In addition, patient-participants rated their self-perceived level of preparedness for participation on a research advisory council.

The responses to the quantitative questions used 5-point Likert scales (e.g., very effective – not at all effective) (see Supplemental Materials 5 and 6). For each phase of training, participants were first asked what they found valuable about the experience. They then rated its value using a 5-point Likert scale. Across phases, participants’ responses to this open-ended question typically referenced their learning or the module as a whole rather than specific components.

Statistical analysis was conducted via Microsoft Excel 2024 and SAS Release 3.82 Enterprise Edition. Significance was set at 0.05.

Open-ended responses were analyzed using a combined inductive-deductive thematic analysis, a method for identifying, analyzing, and reporting patterns or themes in qualitative data [23]. Inductive coding allowed themes to emerge from participant language, while deductive coding was informed by the structure of the interview guide and corresponding survey items. The responses were reviewed to identify recurring patterns and justifications that elaborated on participants’ quantitative ratings. Themes were developed on the basis of participant language and aligned with corresponding survey items, allowing the integration of qualitative insights with quantitative findings.

The second author conducted the interviews; the first author coded and synthesized the results, which were reviewed collaboratively. Disagreements were resolved by consensus. To ensure rigor, we followed Sandelowski [24] criteria for credibility, fittingness, auditability, and confirmability. Credibility was supported by coding directly from verbatim transcripts, reviewing themes iteratively against the data, and using participant quotations to demonstrate alignment between the findings and participants’ perceptions. To ensure fittingness, only participants who completed phases of training were included. To maintain auditability, an audit trail was maintained throughout the research process. For confirmability, the findings were based only on participants’ quotes from the research data source, and these quotes characterized the data as a whole.

Results

Patients and caregivers were combined into one group due to the small number of caregivers. The sample size was too small to support quantitative subgroup analysis. Qualitative distinctions were made between participant types when possible.

Quantitative results

The participants rated Phase 2 highest in value, perceived effectiveness, and quality (Phase 1 range: 3.38–4.13; Phase 2: 4.2–5; Phase 3: 3.6–4.7). The textbook in Phase 2 received the highest individual score for perceived effectiveness (5), whereas the team contract in Phase 3 received the lowest score (2.7). Overall, participants reported that the training met their objectives, M = 4.5, and Phase 2 was the phase they were most likely to recommend, M = 4.7. Self-reported engagement levels in Phases 2 and 3 were high, M = 4.4. One participant did not recall Phase 1 modules, and one struggled to answer questions about Phase 3 (see Table 1).

Table 1.

Quantitative Results: Number of Ranked Responses, Total Score, Mean

Itemsa	Response Optionsb					Total	n	Mean/Mediane
	1	2	3	4	5
Phase 1. PCORIc Online Modules
How valuable	1	0	1	3	3	31	8	3.88
How effective
Video	0	3	1	2	2	27	8	3.38
Quizzes	0	2	0	2	4	32	8	4
PPTd Slides	0	1	0	4	3	33	8	4.13
Knowledge
Pre-training	4	3	2	0	0	16	9	2
Post-training	0	1	2	3	3	35	9	4
Phase 2. Mastering Dry Eye
How valuable	0	0	0	1	9	49	10	4.9
How effective
Text book	0	0	0	0	10	50	10	5
Study Guide	0	1	0	5	4	42	10	4.2
Quizzes	0	1	0	2	7	45	10	4.5
Discussion sessions	0	0	2	3	5	43	10	4.3
Final Exam	0	0	2	1	6	40	9	4.44
Quality
Mastering Dry Eye training	0	0	0	2	8	48	10	4.8
Quizzes	0	0	2	2	6	44	10	4.4
Discussion sessions	0	0	2	3	5	43	10	4.3
Study Guide	0	0	2	4	4	42	10	4.2
LMS	0	0	1	4	5	44	10	4.4
Text book	0	0	0	1	9	49	10	4.9
Engagement	0	0	1	4	5	44	10	4.4
Knowledge
Pre-training	0	3	5	1	1	30	10	3
Post-training	0	0	0	6	4	44	10	4
Phase 3. Practicum
How valuable	0	0	1	1	8	47	10	4.7
How effective
Study Guide	0	2	3	0	4	33	9	3.67
Instruction sessions	0	0	4	2	2	30	8	3.75
Team Contract	1	5	1	2	1	27	10	2.7
Assignments
Written	1	0	1	0	7	39	9	4.33
PPT slides	1	0	1	0	7	39	9	4.33
Addendum	1	0	3	0	5	35	9	3.89
Quality
Practicum	0	1	1	3	5	42	10	4.2
Contract Effect	0	2	2	3	3	37	10	3.7
Materials	0	2	1	6	1	36	10	3.6
Prepared for Council	0	1	1	1	3	24	6	4
Engagement	0	0	1	4	5	44	10	4.4
Knowledge
Pre-training	4	2	3	0	1	22	10	2
Post-training	0	0	4	3	3	39	10	4
Overall
Met objectives	0	0	2	1	7	45	10	4.5
Compensation	0	0	1	2	7	46	10	4.6
Likely to recommend
PCORI modules	0	1	2	3	4	40	10	4
Mastering Dry Eye	0	0	0	3	7	47	10	4.7
Practicum	1	0	0	4	5	42	10	4.2

Abbreviations: LMS, learning management system; PCORI, Patient-Centered Outcomes Research Institute; PPT, PowerPoint slides

^a All items are abbreviated. See Supplemental Material 5 for the full text of each item

^b Response options were on 5-point Likert scales (1 = low, 5 = high). The values represent the number of responses per item

^c PCORI online training modules are available on the Patient-Centered Outcomes Research Institute (PCORI) website: https://www.pcori.org

^d PowerPoint (PPT) slides provided by PCORI were used in the training

^eMedian scores for knowledge items, pre-training and post-training. Mean scores for all other items

Each phase was independently evaluated using the Wilcoxon signed-rank test to assess within-subject changes in self-reported pre- and post-training knowledge. Across phases 1, 2 and 3, the median scores for self-reported knowledge increased from pre‑training to post‑training: Phase 1 Mdn = 2, 4; Phase 2 Mdn = 3, 4; and Phase 3 Mdn = 2, 4. Wilcoxon signed‑rank tests indicated that pre- and post-training self-reported knowledge scores were statistically significantly different for each phase, W = − 22.5, p = .0039. The effect sizes for each phase were large, r = .96, 0.91 and 0.91, respectively. These results indicate statistically significant changes in participants’ self-reported knowledge across all phases. However, results should be interpreted with caution due to small sample size, restricted response ranges, and potential ceiling effects.

A series of nonparametric analyses was conducted to compare pre-training, post-training, and changes in self-reported knowledge scores across the three training phases. A Friedman test revealed a statistically significant difference in pre-test scores across phases, χ²(2) = 9.08, p = .011, indicating that participants did not begin the training at equivalent baseline levels. Follow-up Wilcoxon signed-rank tests, using a Bonferroni-adjusted significance threshold of 0.0167, showed that all three pairwise comparisons were statistically significant. Pre-test scores for Phase A were significantly lower than those for Phase B (p = .0039) and Phase C (p = .0039), and Phase B scores were significantly higher than Phase C (p = .0039). These results confirm meaningful baseline differences among the three modules.

In contrast, no significant differences were observed among phases at post-test, χ²(2) = 3.00, p = .223, suggesting that participants reached comparable levels across modules following the training. The Friedman test on change scores approached but did not reach statistical significance, χ²(2) = 5.69, p = .058, indicating a trend toward differential improvement that did not meet the conventional threshold for significance. Overall, participants began the program with uneven baseline scores, improved across all modules, and ultimately achieved similar post-training performance, with no statistically reliable differences in the magnitude of improvement across phases.

Exploratory analyses were conducted to examine whether researchers (n = 3) and patients/caregivers who completed all three phases (n = 6) differed in their pre-test, post-test, or change scores. No significant differences were found between groups; however, given the very small subgroup sizes, these findings should be interpreted with caution.

Qualitative results

Qualitative analysis focused on participants’ experiences with and perceptions of the training content and delivery, rather than on explanations for their numeric self-ratings of knowledge gains. Quotations are attributed using participant numbers, with p/c indicating patient- or caregiver-participants and r indicating researcher-participants.

Phase 1 Results: PCORI online modules

The PCORI online modules were valued for explanations of the research process (“A very comprehensive review of studies and how to design studies” [P1, p/c], " I learned how research topic was born and what kind of method to fit the research, how they conclude the research and come up with the conclusion.” [P4, p/c]), and for introducing patient-centered CER (“the PCORI online modules, were valuable in teaching us about patient-centered…outcomes and involving patients in the research…” [P10, p/c]), as well as for the various training formats, including videos (“Seeing videos of patients who had worked with researchers through that PCORI training was valuable…“[P7, p/c]), quizzes (“Because you see the video, then you have the PowerPoint, but once the information impressed on my mind, it’s the quizzes. Because if I don’t know the answer I have to go back. Or if the answer is not very clear, I still have to go back and relearn. So, the quizzes work the best.” [P8, r]), and slide presentations (“I like having written work” [P6, r], “I’m more a reader, not necessarily a video person” [P1, p/c]). However, several participants noted barriers to engagement including redundancy and tedium (“It seemed they went on forever.” [P5, p/c], “They were just a little bit redundant and stretch out too long.” [P6, r], confusion about the content, (“I’m…still not sure how the rubber meets the road. I’m still not sure exactly how it works.” [P7, p/c]), and how it connected with their goals of learning about dry eye (“They were valuable in that sense, that it taught me about that topic…It had no value to me in regards to dry eye.“[P9, p/c, ]). The length of time between Phase 1 and Phase 3 contributed to the confusion of purpose. (“It was like…18 months before we actually did the study… design. So, at that time, I really didn’t understand really the whole setup of the thing… it was just confusing for me to understand what we were doing” [P1, p/c].) One of 10 participants (10%) did not complete this phase. One of nine participants (11%) struggled to recall this phase, suggesting possible recall bias. However, recall bias did not prevent qualitative data collection.

Phase 2 Results: Mastering Dry Eye

Nine out of ten participants reported that learning about eye anatomy, dry eye pathophysiology, comorbidities, symptoms, diagnosis, treatments, causes, and terminology was very valuable, (“I learned anatomy, more of the technical side of dry eye disease, terminology.” [P7, p/c], “I actually learned a lot more than I had previously known as far as vocabulary words, the scientific field of it, different comorbidities that cause the inflammation that causes dry eye disease, and overall, more knowledge and experience than I had prior.” [p5, p/c]), including those who had read the textbook previously. (“I was mostly surprised about how much I did not know that I didn’t pick up from reading the book on my own [Participant 9].) The researcher-participants reported valuing foundational knowledge of dry eye (“More knowledge on dry eye, symptoms, diagnosis.” [P3, r], “Learning the general physiology of eye health was new information for me.” [P6, r]), and its role in informing future studies. (“I learned about what research projects could be undertaken in this area, and I learned a lot about dry eye” [P8, r].) Patient-participants cited personal experience, preparation for the council, and advocacy work as motivators for participation. (“Because I am a patient advocate. I talk to people that are in the infancy stage of this disease from all over the world. And, I was able to become a better patient advocate to give them more technical information about how this disease works.” [P9, p/c], “I think that was certainly valuable to the extent that I’m going to be working with the researchers on that topic, I would need to have that information.” [P7, p/c].)

Participants rated the textbook highly for its content, clarity, organization, and depth. (“It was in a format that was really easy for me to comprehend. It was very straightforward.” [P1, pc], “It gave all the information that we needed.” [P6, r], “It’s a very well-written book. And so it was… a great way to learn.” [P10, p/c], “The book was very easy to understand and comprehend, and that translated to really pretty easily taking the quizzes.” [P1, p/c]).

Quizzes were appreciated for reinforcing learning, though some participants reported occasional confusion. (“They were a little bit frustrating but it was like I’m gonna get this no matter what.” [P5, p/c],“The questions were worded and created a little confusion.” [P3, r].)

Participants reported valuing the discussion sessions for peer engagement and reinforcing learning. (“The discussion sessions I found very effective. Just like I said before, I think when you’re talking to other people, and seeing their perspective, and understanding, and all of us discussing things together, it really helps you understand the problem better.” [P10, p/c], “It gave me a chance to go over the materials that we were supposed to learn every few weeks.” [P5, p/c].) Although several participants reported that discussion sessions sometimes veered off topic or caused confusion. (“ Somewhat effective because it’s digressing sometimes.” [P4, p/c], “There were times when nobody really knew why we were doing what we were doing, and we probably should have.” [P7, p/c].)

One patient-participant proposed that instructors review the chapter material in advance of small-group sessions to enhance discussion quality. (“You know, this is the overview and here’s where we are on the continuum, and this is the eye, and this is what we’re learning about today. And that would have made it more effective for me. " [P7, p/c].)

Overall, participants described the training as professional, well organized, and helpful for increasing knowledge of dry eye. (“That was what I was after, and that was an unbelievably professionally done… It was well done, it was, it was very informative, it taught us a lot, I believe it was an excellently prepared course.” [P9, p/c].)

Phase 3 Results: Dry eye patient council practicum

Patient-participant perceptions of the practicum varied, although they reported that they valued learning about the research process and gaining experience. (“I felt better equipped to be talking to researchers about a research project” [P7, p/c], “How you come up with the hypotheses and how you conduct the study, how finalize the study. The whole process is just fascinating to me.” [P4, p/c], “I did not enjoy that part of it at all. it was tedious. I did learn from it.” [P9, p/c].) Some patient-participants without prior experience reported experiencing stress and emotional distress, particularly when not all team members contributed equally and the burden of completing the project shifted. (“I did not expect it to be this challenging. Had I known, I would have not participated” [P2, p/c], “I think… it was very stressful.” [P5, p/c].) Others reported confusion about assignments. (“We were confused at times, like, what were we supposed to do?” [P9, p/c], “It was frustrating. I felt like it was the blind leading the blind.” [P7, p/c].) Several patient-participants described positive experiences even while being challenged. (“I just thought overall, it was a good experience. It pushed me out of my comfort zone, and I really liked working with my group, and they had completely different backgrounds than us.” [P1, p/c], “While I’m not a researcher, I was surprised at how I could actually go out of my comfort zone to try and do the best looking up, researching information.” [P5, p/c]." It was extremely challenging and emotional for everybody on our team… I was never into research and science, so for me to accomplish this is amazing.” [P2, p/c].)

Project feasibility, a metric in the judge’s scoring rubric, influenced some groups’ topic selection, as did ethics and confounding variables. (“It made you really think about everything from ethical considerations with research to the various problems with research with regard to confounding variables and everything else.” [P10, p/c].) Researcher-participants reported that they enjoyed working with patients recognizing their value in study design. (“They were wonderful, and we had very good discussions. We came up with a good research problem, so it was very useful.” [Participant 8], “Development of a research study from start to finish and having a collaboration, was the most valuable to me.” [P6, r].)

While training patients to become researchers was not a goal of Phase 3, some felt unprepared for membership on the patient council. (“I still don’t feel like I’m a researcher” [Participant 5], “I just feel like there’s a lot more that I would have to learn about it. I have a better understanding than I had before, but I feel like I still have a long ways to go.” [P7. p/c].) One patient-participant expressed a lack of interest in serving on the patient council if it involved significant research. (“I certainly would be happy to… have discussions with researchers and doctors about dry eye research. But as far as actually doing further deep studying and writing… Of course I’m going to do my part, but not in this way.” [P2, p/c].) Others described the experience as rewarding and collaborative. (“I just learned so much, and this is the first study, actually from the beginning to the end, we designed ourselves.” [Participant 4].)

Results overall

Patient-participants reported being motivated by the opportunity to learn about dry eye (“I wanted to learn more about dry eye disease, how to research and take away more knowledge of something that was really unknown to me prior.” [P5, p/c]. “I learned about the disease. I got down into the weeds on the disease, and I learned all different facets of the disease, and that was what I thought I was going in for, and that is what I expected.” [P9, p/c]), and to advocate for patients (“More ability to advocate for dry eye patients.” [P2, p/c]). Researchers were motivated by insights into the patient experience (“To learn more about the patient experience and learning what patients go through.” [P3, r], “As I heard all the patients’ personal stories, and how this disease has impacted them, and how research can really make a difference, and hearing them motivated me.” [P6, r]). Compensation was not described as a primary factor (“I would have participated with this completely voluntarily.” [p10, p/c], “It was good use of my time, I did not expect, any compensation.” [P8, r]).

Participants viewed Mastering Dry Eye as essential preparation for the practicum (“The background knowledge learned in Mastering Dry Eye is very important for this experience.” [P6, r]). Patient-participants described increases in their understanding of dry eye, but the perceived increases in understanding did not influence approaches to personal disease management by patients, which they attributed to either prior years of experience managing the disease (“It hasn’t changed how I manage or cope because I’ve been coping and managing for 15 years.” [P5, p/c]) or reliance on physician guidance (“The way I change the way I manage or cope with my disease has been through [my doctor].” [P2, p/c]). Participants reported valuing peer connections (“It was an awesome experience. I met a lot of good people, made a lot of good bonds and friendships” [Participant 9]), and expressed interest in future research involvement (“It’s certainly made me want to do more research and push for more research on dry eye” [Participant 10]).

Discussion

This mixed methods study evaluated the feasibility and participant-reported perceptions of a multiphase training program designed to prepare patients and researchers for meaningful collaboration in dry eye patient-centered CER. The quantitative and qualitative findings converged indicating the program’s success while identifying areas for refinement.

Given the small sample size, we applied the nonparametric Wilcoxon signed-rank test across all phases to ensure consistent analysis. Statistical analyses revealed consistently large gains in self-reported knowledge across all phases, with effect sizes exceeding conventional thresholds, W = -22.5, P < .01, r ≥ .91. These results suggest that participants perceived increases in their knowledge related to readiness for research engagement. However, large effect sizes in small samples should be interpreted with caution due to limited statistical power, restricted response ranges, and potential ceiling effects. Notably, Phase 1 produced the largest effect size despite receiving the lowest subjective ratings, suggesting the importance of foundational research-focused content, specifically exposure to the novel concepts of patient-centered CER even for experienced researchers. However, although structured prompts were used, the Phase 1 results may have been affected by recall bias, with two of the nine participants who completed the training needing one prompt and one requiring two prompts which may have reduced the specificity or richness of their reflections.

The Friedman test did not reveal statistically significant differences in self-reported knowledge gains across the three phases of training, suggesting that participants perceived each module as contributing equally to learning. These findings support the relevance and inclusion of all three phases of training—1) research methods and patient-centered CER, 2) disease-specific education, and 3) a simulated collaborative research experience—as important for preparing patients for participation on a research advisory council. However, further research is needed to assess the distinct contributions of each phase.

Phase 2 emerged as the most well-received component. The participants consistently rated the materials and methods highly. The textbook and small-group discussions were noted for their depth and accessibility. Assessments (quizzes and final exam) reinforced learning. Disease-specific education empowered patients as patient advocates and as partners in research but did not influence patients’ disease management strategies, which they attributed to the duration of illness and reliance on physician guidance. Researcher-participants emphasized the importance of foundational knowledge of dry eye.

Phase 3 offered a simulated experience in study design and team-based collaboration. While participants reported knowledge gains, some appreciated aspects of the training, while others expressed confusion and frustration. However, this discomfort may reflect productive disequilibrium that contributes to deep learning [25]. Furthermore, the practicum was designed to surface these tensions in a simulated environment, allowing participants to develop confidence before engaging with research teams on real, not mock, research studies. Nevertheless, findings suggest that while experiential learning is effective, additional scaffolding may be needed to support novice patient-participants with limited research experience. Such scaffolding could include more guided practice in writing research questions, clearer instructions for conducting a focused literature review tailored to the practicum assignment (e.g., limiting the review to two or three peer-reviewed articles), revisiting CER-specific sections of the PCORI modules, and providing additional examples illustrating study feasibility, outcomes and endpoints, framing, and sample size considerations. Importantly, the practicum fostered mutual respect and insight among patient- and researcher-participants, reinforcing the value of co-learning environments.

Across all phases, the participants expressed strong motivation to engage, driven by personal experience with dry eye and a desire to contribute meaningfully to research. Compensation was not a primary motivator. While not all patient-participants felt fully prepared for council membership, the training was widely viewed as a critical step toward meaningful patient‒researcher partnerships.

These findings affirm the feasibility of a structured, multiphase training model for preparing diverse stakeholders to engage as partners in dry eye-related CER. Future adaptations may benefit by differentiating support for participants with varying research backgrounds and emphasizing clearer connections between training content and research-specific advisory responsibilities. Additionally, although discussion prompts and suggested timings were provided for online group sessions, the study revealed that small-group conversations sometimes drifted off topic. Future programs should consider assigning a timekeeper and a discussion facilitator from among the group’s members to help keep sessions focused.

This study has several limitations. First, the small sample size and single-disease focus limit generalizability to broader populations or other disease contexts, while statistical results should be interpreted with caution due to limited statistical power, restricted response ranges, and potential ceiling effects. Second, interviews were conducted approximately four months after the conclusion of a 2-year training program, introducing potential recall bias. The longer interval may have disproportionately affected recall of Phase 1 and may have contributed to variability in results across phases. Third, the instructional systems designer who conducted the interviews was known to the participants, which may have influenced their responses due to social desirability bias. Fourth, external validation of qualitative coding was not conducted due to budget constraints. Instead, the project lead—who was also involved in program design, delivery, and funding acquisition in addition to being a patient and patient advocate—coded and synthesized the qualitative data, raising the possibility of interpretive bias despite efforts to ensure transparency and rigor. Fifth, while the training was designed to simulate real-world research collaboration, participants’ experiences may not fully reflect the dynamics of actual research partnerships. Sixth, the project was conducted only in English with US-based patients and researchers, the majority of whom were female, which may also limit generalizability. Seventh, the patient-advocacy focus of the project may further limit generalizability to research, academic or other settings. Eighth, the study focused on the feasibility and participant-reported perceptions of the multi-phase training program and does not assess behavioral capability or downstream impact on research design. Consequently, the effectiveness of the program in influencing research processes or outcomes remains unknown. Finally, the absence of a comparison group limits the ability to attribute observed outcomes solely to the training intervention.

Future research should examine how the council’s participation shapes patient-centered research processes in funded studies, including impacts on protocol design, endpoint selection, outcomes, health technology assessments, and engagement among council members and research partners.

Conclusion

The formation of the Dry Eye Patient Council represents a meaningful step in embedding patients’ lived experiences and expertise into the research process. This initiative described here addresses a critical gap in dry eye research—the absence of structured, meaningful patient engagement, not just as subjects but as partners in the research process—and demonstrates the feasibility of comprehensive training grounded in scientific literacy and methodological rigor. The participants emerged with a shared vocabulary and reported having expanded knowledge important for meaningful contribution to patient-centered CER. The council’s development model—anchored in sustained engagement, bidirectional learning, and cocreation—may offer a replicable framework for other disease communities seeking to amplify the patient voice in research.

In addition to demonstrating feasibility, our experience suggests several practical considerations for others developing patient council training programs. A phased approach that introduces foundational CER concepts, incorporates disease-specific education, and provides opportunities for applied learning (such as a practicum/simulation) may help reinforce understanding and build confidence among patient council members. Bidirectional learning—where patients/caregivers and researchers learn from one another—can strengthen engagement and deepen shared insight. Given that some participants experienced confusion or frustration, reinforcing expectations and offering support as learners encounter unfamiliar material may also be beneficial, as would minimizing the time between phases of training. Although developed for a single-disease context, these principles may be adaptable to other disease communities seeking to prepare patients for meaningful involvement in research.

Integrating such councils at the earliest stages of study design has the potential to shape research priorities, enhance the relevance of studies, and improve patient outcomes. Next steps for the Patient Council include transitioning from training to active advisory roles in dry eye-related CER and other research, and identifying opportunities to contribute patient perspectives from the earliest stages of a study’s development through its completion. Sustainability and scalability will depend on continued investment, institutional partnerships, and a cultural shift that positions patients not solely as subjects but also as indispensable collaborators, together pursuing better science and better care.

Supplementary Information

Below is the link to the electronic supplementary material.

Abbreviations

CER

Comparative effectiveness research

PCORI

Patient-Centered Outcomes Research Institute

LMS

Learning management system

IRB

Institutional review board

Author contributions

NAW and JRA jointly conceptualized the study and developed the methodology. JRA conducted the investigation and data collection. NAW carried out the formal analysis. Both authors contributed to writing the original draft and participated in reviewing and editing the manuscript. Project administration and funding acquisition were undertaken by NAW. Both authors read and approved the final manuscript.

Funding

This project was funded through a Patient-Centered Outcomes Research Institute^® (PCORI^®) (1333 New Hampshire Ave NW, Washington, DC 20036) Eugene Washington PCORI Engagement Award [EASO-29000]. The views, statements, and opinions presented in this work are solely the responsibility of the authors and do not necessarily represent the views of PCORI^®. The funding organization participated in funding the project and publication of this study.

Data availability

The quantitative dataset supporting the conclusions of this article is included within the article. Themes, codes, and representative quotes are provided in Supplemental Materials. To protect participant anonymity given the small sample size, the entire qualitative dataset is not available.

Declarations

Ethics approval and consent to participate

All participants provided written agreement to participate in the training activities and verbal consent to respond to interview questions. The study received an exemption determination from the Institutional Review Board at the University of Central Florida, Office of Research, Orlando, Florida, USA.

Consent for publication

Both authors approved the final manuscript and consented to its publication in Research Involvement and Engagement.

Competing interests

Natalia A. Warren chairs the Not A Dry Eye Foundation, the first patient-founded non-profit organization dedicated to raising awareness of dry eye.