Andrew Kouri,1,2 Zoe Garzouzi,3 Anna M Chudyk,4 Alexander Singer,5 Stacey J Butler,3 Bryan A Ross,6 Samir Gupta2,3

1Department of Medicine, Division of Respirology, Women’s College Hospital, Toronto, ON, Canada; 2Department of Medicine, University of Toronto, Toronto, ON, Canada; 3Department of Medicine, Division of Respirology, St. Michael’s Hospital, Unity Health Toronto, Toronto, ON, Canada; 4College of Pharmacy, University of Manitoba, Winnipeg, MB, Canada; 5Department of Family Medicine, University of Manitoba, Winnipeg, MB, Canada; 6Translational Research in Respiratory Diseases Program and Respiratory Epidemiology and Clinical Research Unit, Research Institute of the McGill University Health Centre, Montréal, QC, Canada

Correspondence: Andrew Kouri, Department of Medicine, Division of Respirology, Women’s College Hospital, 76 Grenville Street 4th Floor, Toronto, ON, M5S 1B2, Canada, Email [email protected]

Purpose: Effective COPD management depends on structured symptom and risk assessment, individualized therapy, and action plan provision, yet these are inconsistently delivered in routine care. Electronic health record (EHR)-integrated clinical decision support systems (CDSSs) can help close these gaps but require accurate, structured patient data to drive their recommendations. Digital pre-visit questionnaires are increasingly used to collect such data, but patient preferences for their content and design remain poorly understood, particularly in COPD.
Patients and Methods: We used a user-centered design process to develop an electronic COPD questionnaire to inform an EHR-integrated CDSS. Content was mapped to planned CDSS actions and built into a mobile-optimized prototype using eHealth design principles. We face validated the prototype with 10 people living with COPD, then refined it through successive focus groups until saturation. Usability was assessed with the System Usability Scale (SUS) and Likert ratings and transcripts were analyzed thematically.
Results: Face validation (n=10) and three focus groups (n=13) were conducted to saturation. Four critical issues were identified and addressed. Usability was high throughout (mean SUS 88.07, "excellent”), with strong Likert ratings for functionality, navigation, and appearance. Thematic analysis yielded four themes: standardized measures versus real-life experience; usability and format as enablers; support for communication, memory, and efficient care; and desire for transparency and education.
Conclusion: Through iterative co-design with older adults, we developed an EHR-integrated electronic COPD questionnaire with excellent usability and relevance to patients’ lived experience. Patients anticipated benefits beyond data capture: improved symptom recall, visit preparation, and provider efficiency. This is one of the first electronic COPD questionnaires developed through structured patient co-design and qualitative evaluation, providing a transferable model for tools that inform clinical decision support.

Keywords: COPD, digital health, electronic health record, clinical decision support, patient questionnaire, user-centered design

Background

COPD is one of the most common chronic diseases in the world, affecting almost 12% of Canadians1,2 and accounting for significant morbidity and major acute healthcare system burden.3 Effective and evidence-based management of COPD is dependent on three fundamental principles: 1) comprehensive symptom and risk assessment,4–6 2) choosing the appropriate therapy tailored to each patient,4,6 and 3) provision of a COPD action plan (AP).4,7,8 Unfortunately, these management principles are often not followed in routine care of patients with COPD, leading to important practice gaps that cause avoidable morbidity and mortality, and increase healthcare utilization.9,10

One innovative approach to addressing complex care gaps such as these is the use of point-of-care computerized decision support systems (CDSSs), which can deliver personalized pharmacological and non-pharmacological evidence-based disease management recommendations to healthcare providers within their electronic clinical workflows.11 We previously developed the primary care-facing Electronic Asthma Management System (eAMS) CDSS to tackle comparable care gaps in asthma. A critical component of the eAMS system was a digital patient-facing questionnaire we co-developed with patients to collect the data needed to inform its CDSS algorithms.12–14 As smartphone ownership continues to increase, even among older adults with COPD,15 digital patient questionnaires such as the one we developed for eAMS in asthma are increasingly being used in primary and specialty care settings.16 Prior COPD digital health research has focused mainly on remote monitoring, self-management apps, and exacerbation prediction, whereas patient preferences for the design and content of the pre-visit questionnaires that feed such tools remain largely unstudied, particularly in COPD.17,18 Establishing these preferences through direct patient co-design is the central rationale for this study.

Herein, we describe the iterative, user-centered development of a novel digital COPD patient pre-visit questionnaire, intended to inform the application of an electronic health record (EHR)-integrated CDSS targeting the important COPD care gaps discussed above. This process sought to identify the content, format, and usability preferences and requirements for successful electronic data collection in people living with COPD.

Methods

To inform the design of a patient-facing digital questionnaire that aligns with the needs and preferences of individuals living with COPD, we used an iterative, user-centered development approach. This approach was designed to both generate and refine questionnaire content, format, and usability through successive stages of development and user feedback. The process consisted of three phases: 1) prototype development; 2) face validation; and 3) testing and refinement through a rapid-cycle user-centered design (UCD) process,13,14,19 with accompanying qualitative analysis of UCD focus group transcripts to synthesize user feedback and identify key themes related to questionnaire design and usability. Methods across all three phases are presented below. The study was approved by the St. Michael’s Hospital Institutional Review Board (REB# 25–005).

Prototype Development

CDSS deliver personalized evidence-based disease management recommendations to healthcare providers. Thus, prototype content development started with a mapping exercise that matched desired CDSS actions to patient data inputs required to inform corresponding recommendations. Planned COPD CDSS actions included: 1) determining objective symptom burden and exacerbation risk; 2) optimizing pharmacotherapy according to symptom burden and exacerbation risk; 3) auto-filling an individualized COPD action plan; and 4) prompting providers to offer smoking cessation advice, where applicable.

Based on the Canadian Thoracic Society COPD Guideline on Pharmacotherapy in Patients With Stable COPD,6 we determined that symptom burden assessment would require dyspnea assessment through the Modified Medical Research Council (mMRC) Dyspnea Scale (a scale measuring dyspnea level from 0 to 4) and impact assessment through the 8-question COPD Assessment Test (CAT). Exacerbation risk assessment would require an evaluation of the number, type (mild/moderate versus severe), and timing of prior exacerbations. Personalized pharmacotherapy recommendations including COPD action plan content would require assessment of current COPD therapy, and targeted smoking cessation advice delivery would require identification of current smokers. Based on these criteria, our core development team of two pulmonologists with expertise in eHealth and implementation science (AK and SG) developed the initial prototype content.

In designing prototype format and usability, we sought to design a tool that would principally be accessed using a smartphone or tablet. We used the original patient-optimized eAMS questionnaire as a base,13,14,20 and followed these established principles for patient-facing eHealth tool design: 1) suitability across adult ages and genders, 2) ability to efficiently complete the questionnaire without prior training, 3) responses entered by user action (as opposed to default answers), and 4) where possible, information necessary to answer each question available on the question screen.21 Specific features to address the typically older patient population affected by COPD (as informed by our recent work)22,23 included: 1) large radio buttons for answer selection, (2) a scrolling system for increases or decreases in numerical entry values, and (3) minimal text entry requirements. Medication entry was facilitated by inhaler pictograms, which were shown to be intuitive to users of the eAMS.13

Face Validation

Next, we presented the prototype to a group of people with lived experience (PWLE) with COPD for face validation and further feedback. This was the patient “Hive”, an advisory board consisting of 10 individuals living with COPD established independently of this study through community recruitment, to inform our work in COPD. This group consists of 5 men and 5 women from urban and rural settings across seven Canadian provinces, with a mean age of 74.3 (SD 5.2) years, and having been living with COPD for a mean of 9.6 (SD 8.7) years. Prior to meeting with Hive members, we emailed them an explanation of the purpose and use case for the electronic questionnaire along with unique logins and instructions to test the questionnaire. Members then attended a 1.5-hour semi-structured virtual meeting moderated by a content specialist (AK) and a patient engagement expert (AC). Each slide in the questionnaire was presented, and Hive members were probed for their perspectives on its content, usability, format, clinical impact, and possible improvements. Following the meeting, 2 study team members (AK and ZG) independently reviewed the meeting transcript to identify suggested changes. Proposed changes were presented to the research team for consensus agreement, after which corresponding changes were incorporated into the prototype questionnaire.

Rapid Cycle User-Centered Development

In line with our previous work developing and evaluating airways electronic clinical decision support tools,13,14,19 we then undertook a rapid-cycle user-centered design process to further refine and optimize the prototype electronic COPD questionnaire. This process involved a repeating cycle of 3 steps: 1) testing the questionnaire in a patient focus group, 2) reviewing the focus group transcript for emergent and critical issues, and 3) adjusting the questionnaire according to patient feedback. Focus groups were conducted virtually by a moderator with qualitative research experience (AK) and attended by another member of the research team (ZG). Based on our previous work,13,14,19 we estimated that 3–5 rounds involving 10–20 participants would be required to attain data saturation.

Inclusion criteria were as follows: age ≥18 years of age, physician-diagnosed COPD, taking any inhaler medication, and the ability to read, write and speak English. We recruited participants from a respiratory patient research database at our tertiary care institution (Unity Health Toronto - Toronto, Ontario), consisting of patients with a chronic respiratory condition who had previously agreed to be contacted for research. Patient data were reviewed for inclusion criteria and qualifying participants were contacted by telephone for study invitation. We also recruited community participants through the patient organization COPD Canada. Members of COPD Canada’s patient partner database received an organizational Email providing details of the study along with a contact email, and interested individuals contacted the study team. All participants provided informed consent prior to focus group participation and received a $50 e-gift card for their time.

Prior to each focus group, consenting participants were emailed login credentials and asked to access the prototype questionnaire online. We encouraged participants to complete the questionnaire on a mobile device (smartphone or tablet) prior to the focus group in order to familiarize themselves with it and to consider their feedback. Focus groups were then held virtually using a secure videoconference platform (Zoom for Healthcare). During each focus group, the moderator used a moderator script to elicit structured feedback relating to preferred questionnaire content (including information quality), format/usability (including readability, display, electronic user interface), clinical impact, and overall impressions (see Appendix 1). The focus group format was semi-structured, allowing for a participant-driven discussion, while also covering these key evaluation components. Focus groups lasted between 60–90 minutes and were audio-recorded. Following completion of each focus group, participants were emailed a questionnaire collecting demographic information and administering the System Usability Scale (SUS) as a measure of global system usability,24,25 along with Likert-style usability-related questions.

After each focus group, transcripts were generated verbatim, and in combination with field notes, a list of all feedback was independently created by two study team members (AK and ZG). Proposed solutions to participant-identified issues were also generated, drawing from both participant suggestions and research team insights. Issues in the list were categorized as “critical” or “emergent”. A priori, we defined critical issues as those that were considered important by all participants within a single focus group, or by most participants across multiple focus groups, and/or that were deemed beneficial and feasible to implement by the investigator team. Emergent issues were those expressed by more than one participant across a single focus group which did not meet the threshold for critical. Emergent issues could be reclassified as critical after appearing in two or more focus groups. After each focus group, changes were made to the electronic questionnaire to address critical issues. We continued this process until no new critical issues emerged from a single focus group, which we defined a priori as our design saturation criteria.14,19

Qualitative Analysis

Following the final focus group, a member of the research team with expertise in qualitative analysis (AK) conducted thematic analysis on all transcripts. After reading each transcript, codes representing distinct concepts/ideas from each participant were grouped together into categories, which then determined overall themes related to system usability and content preferences.26–28 Themes were discussed and finalized by consensus discussion among three members of the research team (AK, ZG, SG). Representative quotations were extracted for each final theme.

Results Face Validation

The Hive group meeting took place in February of 2025 and included all 10 patients with COPD. Hive members found the questionnaire easy to navigate, felt that instructions were clear, and perceived that it would provide meaningful information to providers. They also believed completing the questionnaire could empower patients to better understand their condition. In terms of potential changes, they desired a method to provide more personalized information to their providers and recommended an explicit definition of “COPD exacerbations” to minimize patient confusion. To address this, we added the following statement on the final questionnaire screen: “If there is anything else about your COPD that was not included in this questionnaire and that you want to discuss with your provider, please remember to do so at your next appointment”. We also added a guideline-concordant definition for the term “COPD exacerbation” in-text (“a worsening in respiratory symptoms which often requires treatment with antibiotics and/or steroids”).6

Rapid-Cycle Development

We conducted three rounds of focus group discussions between April - August 2025 before our saturation criteria were met. Our sample included 13 participants, of whom 9 (69.2%) were women. The mean age was 75 years (SD 6.0 years, range 65–85 years), the majority (61.5%) had completed post-secondary education, and most (61.5%) used mobile devices several times a day.

System Changes

Throughout the focus groups, four critical issues were identified that resulted in changes to the questionnaire. Critical issues and corresponding changes are presented in Table 1. See Appendix Figure 1 for final questionnaire screenshots.

Table 1 Critical Issues Identified by Focus Group Participants and Corresponding Improvements

Usability Ratings

Usability ratings were high throughout focus groups, with an overall mean System Usability Scale score of 88.07 (SD 10.80, range 75 to 100). This represents “excellent” usability.29 Overall, participants responded positively to Likert-style questions addressing app functionality, navigation, and appearance (Figure 1).

Figure 1 Likert Questionnaire Responses from Focus Group Participants (n=13).

Qualitative Analysis

Qualitative analysis identified four overarching themes and 12 subthemes reflecting participants’ perceptions of the electronic COPD patient questionnaire.

The first overarching theme was “Standard measures versus the real-life experience of COPD”. Participants felt the questionnaire addressed “core” aspects of COPD but also noted that standardized questions do not fully capture the day-to-day variability and personal context of their disease. To manage this, they expressed a desire for opportunities to provide additional personal narrative information to their providers. The second theme was “High usability and format as enablers”. Participants described the questionnaire as clear, simple, and easy to complete, highlighting readability, intuitive navigation, and inhaler images as facilitators of use. The third theme was “Supporting communication, memory, and efficient care”. Participants anticipated that completing the questionnaire before appointments would help them to reflect on their symptoms, recall important things to discuss with their providers and prepare for care discussions, and support providers in making more efficient and informed decisions. Participants who noted that they had experienced rushed or inefficient care saw the greatest potential benefit. The last theme was “Desire for transparency and educational value”. Participants expressed interest in understanding how their responses would be used within the broader clinical decision support system and wanted access to further educational content. Illustrative quotations for each theme and subtheme are presented in Table 2.

Table 2 Illustrative Quotations for Each Subtheme

Discussion

In this study, we developed and refined an electronic COPD patient questionnaire intended to capture essential patient data to inform application of key COPD guideline recommendations through an EHR-integrated clinical decision support system. Pre-visit questionnaires are used increasingly in care, and must empower patients to efficiently provide accurate, structured, and clinically relevant inputs. However, existing COPD electronic questionnaires have not been co-developed with end-users, presenting a potential challenge to usability.18,23,30–32 Our multi-stage, iterative user-centered design process allowed patients with COPD to directly shape questionnaire content, visual presentation, and workflow, resulting in a final tool with excellent usability and clear relevance to the lived experience of COPD. Insights gained through this process may also inform the design of future patient-facing tools in COPD.

Usability in Older Adults

The high usability scores and positive qualitative feedback our questionnaire received demonstrate the importance of age-responsive design in COPD digital tools. COPD disproportionately affects older adults,33 yet most digital health interventions for COPD fail to incorporate usability elements that account for age-related visual, motor, and cognitive changes, thereby falling short on readability, usability, and simplicity metrics.22,23 Our work contributes new evidence that when age-responsive design principles are applied intentionally and validated through iterative user-centered testing that includes older adults (the mean age of patient evaluators was 74.5 years), electronic questionnaires can achieve high usability and acceptability, particularly in a population that often experiences barriers to using technology.34

Qualitative Feedback

Participants consistently described the core content of the questionnaire as appropriate and comprehensive, however they also emphasized that standardized tools (such as the mMRC and CAT) do not fully reflect the day-to-day variability and personal experience of COPD. This was coupled with a desire to share more nuanced information with providers. This perception has been reported in other chronic disease patient questionnaire studies in COPD and diabetes where patients valued structured assessments but also desired space to communicate nuance and individualized concerns.35,36 Our solution of adding both a brief free-text field for provider communication and explanatory text acknowledging the limitations of standardized scales addressed the desire for personalization without compromising the structured data required for clinical decision support logic, and is an approach that can be proactively applied to future patient-facing digital tools, seeking to balance holistic representation of patient experiences with input reliability.

Beyond simply using the questionnaire as a data-entry mechanism, participants described a range of perceived benefits to engaging with the tool. Many participants felt that completing it prompted self-reflection, helped them to organize their thoughts, and improved their recall of symptoms and events. These observations align closely with the literature on electronic questionnaires across other chronic diseases. In diabetes, a digital patient questionnaire was shown to “broaden the scope” of clinical encounters by highlighting issues patients had not previously discussed.35 In heart failure, a patient-facing app that was part of a larger clinical decision support system increased patients’ awareness of their disease and supported more engaged and efficient consultations.37 Previous qualitative work in COPD has identified a similar phenomenon. In a recent study evaluating a digital COPD patient-reported outcomes questionnaire, patients reported that completing the questionnaire “unmasked” unspoken concerns that later formed the basis of more meaningful conversations with providers.36 Our findings reinforce these patterns and extend them to a structured electronic COPD questionnaire developed specifically to capture symptom, event, and medication use information, and to inform computerized decision support.

Participants also described contextual factors that influenced perceived questionnaire usefulness. Those who previously experienced rushed or inefficient care anticipated that the questionnaire would help to facilitate higher quality assessments. They viewed the questionnaire as a way to support providers and compensate for time constraints or variability in care, which mirrors previous findings from electronic asthma questionnaires17 and COPD digital health adoption research.31 This suggests that the benefit of patient-facing questionnaires may be greatest in settings where clinicians have more limited time and clinical resources.

A novel insight from this study was patients’ desire for transparency and visibility into the specific outputs of clinical decision support. This likely reflects a broader shift in expectations around digital health transparency and aligns with studies showing that patients want feedback loops and are increasingly interested in being active participants in their care.17,37,38 Incorporating such feedback loops may support shared decision making, a priority in COPD management which has been shown to improve inhaler adherence and patient outcomes, while also facilitating adherence and engagement with chronic disease tools.39–41

Comparison with Other Electronic COPD Patient Questionnaires

Research on electronic questionnaires that support COPD care remains limited. Most COPD digital health research has focused on telemonitoring, symptom tracking, and digital action plans rather than structured pre-visit questionnaires designed to inform guideline-based care or clinical decision support systems.31 Although electronic administration of COPD questionnaires and symptom reporting tools have been explored in telemonitoring and digital self-management programs, these studies generally rely on pre-existing questionnaires or clinician-designed symptom checklists.42–45 To our knowledge, none have engaged patients in the co-design of the content and format of a COPD electronic questionnaire, let alone through a structured rapid-cycle iterative design process. As such, this questionnaire is among the few COPD-specific digital instruments purpose-built for self-reported patient data collection that has also been co-developed with patients. Our findings demonstrate several points of consistency with the broader literature on electronic patient questionnaires for chronic disease data capture, as discussed in detail above. However, across diseases, few questionnaires have been developed through prototyping, face validation and iterative end-user testing.13,14 This study demonstrates the feasibility of embedding rapid-cycle qualitative co-design early in tool development and its usefulness for surfacing patient content and format preferences.

Strengths and Limitations

Strengths of this study include a multi-step, theoretically grounded user-centered design process, diverse recruitment across both specialty and community settings, and a mixed-methods evaluation. Iterative cycles allowed for rapid incorporation of patient insights and minimized persistent usability issues. Our high usability scores support the success of this design approach. Limitations include a primarily well-educated and digitally engaged sample, whereby usability may vary in the broader community. Participants were also individuals who self-selected into research, suggesting potentially higher motivation than the general COPD population. Participants may also not represent the full spectrum of COPD severity. Our qualitative analysis also carries methodological limitations. Thematic coding was performed by a single analyst (AK), although the resulting themes were reviewed and finalized through consensus discussion with two additional team members. The absence of independent double-coding may have introduced interpretive bias and reduced the likelihood of identifying alternative themes. Furthermore, our stopping criterion reflected design-based saturation (the point at which no new critical usability or content issues emerged) rather than formal thematic saturation of the qualitative dataset. We therefore cannot claim that all latent themes were fully developed, and our thematic findings should be read as descriptive of this sample rather than exhaustive. Finally, the questionnaire was tested outside of the real-world clinical environment. User perceptions may evolve once the tool is integrated into workflows and used in actual clinical encounters, and clinician perspectives on the tool and the broader clinical decision support system it informs also need to be investigated. Accordingly, our findings establish usability, acceptability, and perceived usefulness in a pre-implementation setting. Real-world uptake, clinician response, integration and workflow fit, and any effect on clinical outcomes remain to be evaluated in future implementation studies.

Conclusion

We developed and optimized an electronic COPD patient questionnaire using an iterative user-centered design process and demonstrated that it has excellent usability and acceptability among older adults with COPD. Participants viewed the tool as being relevant to care, and anticipated benefits that extend beyond structured data capture, including improved symptom recall, enhanced preparation for clinical visits, a clearer understanding of their care, and perceived efficiency and quality gains for their providers. Areas for refinement included contextualizing symptom variability and increasing transparency regarding how a computerized system might utilize their responses. Importantly, the present study supports feasibility and acceptability rather than clinical effectiveness, and the questionnaire has not yet been shown to improve COPD management. Real-world uptake, clinician response, workflow fit, and clinical outcomes remain to be evaluated in routine clinical care. This study fills an important gap in the COPD digital health literature by reporting a structured and rigorous patient co-design process including qualitative evaluations of an electronic COPD questionnaire. Our findings suggest that pre-visit electronic data capture may be feasible in the COPD patient population, through an emphasis on principles of usability and careful patient engagement in system design. Our process and findings can also be applied to the design of other patient-facing tools for people living with COPD.

Data Sharing Statement

Summary of qualitative data analysis available upon reasonable request to the corresponding author.

Ethics Approval

This study received research ethics approval through The Unity Health Toronto REB (REB# 25-005), and complies with the Declaration of Helsinki. Participant informed consent included publication of anonymized responses/direct quotes.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Funding

No funding to declare.

Disclosure

AK has received speaking fees from AstraZeneca and consulting fees from Trudell Medical. BR reports funding as Principal Investigator from QHRN, MUHC-CAS, MUHC-Foundation, MGH-Foundation, Innovation-Partnership Grant (I+&P: McGill & Thorasys), Trudell Medical International Unrestricted Investigator-Initiated Operating Grant, AstraZeneca Unrestricted Investigator-Initiated Operating Grant, and MI-4. He has received of in-kind support for research from Amazentis, Thorasys Inc. and Restech. He has received speaking fees from GSK, AstraZeneca, Covis, the Canadian Thoracic Society (CTS), CHEST, APPQ, AKA, Respiplus, and McGill CPD. Other authors have no conflicts of interest to declare.

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