“A Good Day Is Just Being Able to Breathe”: Aligning COPD Research with Patient Needs, a Qualitative Study

“A Good Day Is Just Being Able to Breathe”: Aligning COPD Research with Patient Needs, a Qualitative Study | medRxiv /* */ /* */ <!-- <!-- /*! * yepnope1.5.4 * (c) WTFPL, GPLv2 */ (function(a,b,c){function d(a){return"[object Function]"==o.call(a)}function e(a){return"string"==typeof a}function f(){}function g(a){return!a||"loaded"==a||"complete"==a||"uninitialized"==a}function h(){var a=p.shift();q=1,a?a.t?m(function(){("c"==a.t?B.injectCss:B.injectJs)(a.s,0,a.a,a.x,a.e,1)},0):(a(),h()):q=0}function i(a,c,d,e,f,i,j){function k(b){if(!o&&g(l.readyState)&&(u.r=o=1,!q&&h(),l.onload=l.onreadystatechange=null,b)){"img"!=a&&m(function(){t.removeChild(l)},50);for(var d in y[c])y[c].hasOwnProperty(d)&&y[c][d].onload()}}var j=j||B.errorTimeout,l=b.createElement(a),o=0,r=0,u={t:d,s:c,e:f,a:i,x:j};1===y[c]&&(r=1,y[c]=[]),"object"==a?l.data=c:(l.src=c,l.type=a),l.width=l.height="0",l.onerror=l.onload=l.onreadystatechange=function(){k.call(this,r)},p.splice(e,0,u),"img"!=a&&(r||2===y[c]?(t.insertBefore(l,s?null:n),m(k,j)):y[c].push(l))}function j(a,b,c,d,f){return q=0,b=b||"j",e(a)?i("c"==b?v:u,a,b,this.i++,c,d,f):(p.splice(this.i++,0,a),1==p.length&&h()),this}function k(){var a=B;return a.loader={load:j,i:0},a}var l=b.documentElement,m=a.setTimeout,n=b.getElementsByTagName("script")[0],o={}.toString,p=[],q=0,r="MozAppearance"in l.style,s=r&&!!b.createRange().compareNode,t=s?l:n.parentNode,l=a.opera&&"[object Opera]"==o.call(a.opera),l=!!b.attachEvent&&!l,u=r?"object":l?"script":"img",v=l?"script":u,w=Array.isArray||function(a){return"[object Array]"==o.call(a)},x=[],y={},z={timeout:function(a,b){return b.length&&(a.timeout=b[0]),a}},A,B;B=function(a){function b(a){var a=a.split("!"),b=x.length,c=a.pop(),d=a.length,c={url:c,origUrl:c,prefixes:a},e,f,g;for(f=0;f<d;f++)g=a[f].split("="),(e=z[g.shift()])&&(c=e(c,g));for(f=0;f<b;f++)c=x[f](c);return c}function g(a,e,f,g,h){var i=b(a),j=i.autoCallback;i.url.split(".").pop().split("?").shift(),i.bypass||(e&&(e=d(e)?e:e[a]||e[g]||e[a.split("/").pop().split("?")[0]]),i.instead?i.instead(a,e,f,g,h):(y[i.url]?i.noexec=!0:y[i.url]=1,f.load(i.url,i.forceCSS||!i.forceJS&&"css"==i.url.split(".").pop().split("?").shift()?"c":c,i.noexec,i.attrs,i.timeout),(d(e)||d(j))&&f.load(function(){k(),e&&e(i.origUrl,h,g),j&&j(i.origUrl,h,g),y[i.url]=2})))}function h(a,b){function c(a,c){if(a){if(e(a))c||(j=function(){var a=[].slice.call(arguments);k.apply(this,a),l()}),g(a,j,b,0,h);else if(Object(a)===a)for(n in m=function(){var b=0,c;for(c in a)a.hasOwnProperty(c)&&b++;return b}(),a)a.hasOwnProperty(n)&&(!c&&!--m&&(d(j)?j=function(){var a=[].slice.call(arguments);k.apply(this,a),l()}:j[n]=function(a){return function(){var b=[].slice.call(arguments);a&&a.apply(this,b),l()}}(k[n])),g(a[n],j,b,n,h))}else!c&&l()}var h=!!a.test,i=a.load||a.both,j=a.callback||f,k=j,l=a.complete||f,m,n;c(h?a.yep:a.nope,!!i),i&&c(i)}var i,j,l=this.yepnope.loader;if(e(a))g(a,0,l,0);else if(w(a))for(i=0;i (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0];var j=d.createElement(s);var dl=l!='dataLayer'?'&l='+l:'';j.src='//www.googletagmanager.com/gtm.js?id='+i+dl;j.type='text/javascript';j.async=true;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-P4HH5NV'); Skip to main content Home About Submit ALERTS / RSS Search for this keyword Advanced Search “A Good Day Is Just Being Able to Breathe”: Aligning COPD Research with Patient Needs, a Qualitative Study View ORCID Profile Laurel O’Connor , Julia Ferranto , Anuska Ganesh Harne , Leah Dunkel , View ORCID Profile Peter Lindenauer , View ORCID Profile Bruce Miller , Christopher Mosher , Fernando Martinez , View ORCID Profile Apurv Soni doi: https://doi.org/10.1101/2025.03.31.25324981 Laurel O’Connor 1 Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School , Worcester, MA, USA Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Laurel O’Connor For correspondence: laurel.oconnor{at}umassmed.edu Julia Ferranto 1 Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School , Worcester, MA, USA Find this author on Google Scholar Find this author on PubMed Search for this author on this site Anuska Ganesh Harne 1 Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School , Worcester, MA, USA Find this author on Google Scholar Find this author on PubMed Search for this author on this site Leah Dunkel 1 Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School , Worcester, MA, USA Find this author on Google Scholar Find this author on PubMed Search for this author on this site Peter Lindenauer 2 Department of Healthcare Delivery and Population Sciences and Department of Medicine, University of Massachusetts Chan Medical School–Baystate , Springfield, MA USA Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Peter Lindenauer Bruce Miller 3 COPD Disease Foundation , Miami, FL USA Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Bruce Miller Christopher Mosher 4 Division of Pulmonary , Allergy, and Critical Care Medicine, Department of Medicine, Duke University School of Medicine Durham NC USA Find this author on Google Scholar Find this author on PubMed Search for this author on this site Fernando Martinez 5 Division of Pulmonary , Allergy, and Critical Care Medicine, Department of Medicine, University of Massachusetts Chan Medical School , Worcester, MA, USA Find this author on Google Scholar Find this author on PubMed Search for this author on this site Apurv Soni 1 Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School , Worcester, MA, USA Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Apurv Soni Abstract Full Text Info/History Metrics Data/Code Preview PDF Abstract Background Chronic obstructive pulmonary disease (COPD) is a common and impactful disease that is the target of a large portfolio of clinical research. However, there is limited understanding of how individuals with COPD perceive trial designs, outcomes, and intervention acceptability. The objective of this project was to explore the perspectives and priorities of patients and their caregivers toward COPD-focused clinical research. Methods Semi-structured interviews were conducted with participants living with COPD and their caregivers using the Theoretical Framework of Acceptability (TFA) to guide data collection and analysis. Interviews were transcribed and coded using qualitative analysis software and analyzed using an inductive thematic approach. Results Fifteen interviews were performed. Key themes included participant preference for outcome measures that directly impact daily living, such as mental wellness and physical function. Participants highlighted the need for research data to be actionable, advocating for health insights to be shared with participants and their healthcare providers. Study engagement was influenced by the perceived burden and complexity of interventions as well as their direct relevance to patients. Patients favored research designs that minimize physical and logistical challenges. Lastly, participants desired greater involvement in the research design process. Conclusions Aligning COPD research with patient priorities requires incorporating meaningful outcome measures, reducing participation burdens, and fostering ongoing engagement. Integrating patient-centered approaches in study design can enhance recruitment, adherence, and the real-world impact of COPD interventions. Introduction Chronic obstructive pulmonary disease (COPD) significantly diminishes patients’ quality of life.( 1 ) It can persistently impact their ability to breathe comfortably, perform daily activities, and maintain social and occupational engagement.( 1 – 5 ) Frequent COPD exacerbations contribute to psychological and physical strain, increasing the risk of anxiety and depression while also resulting in emergency department visits, hospitalizations, and worsening disability.( 3 , 6 , 7 ) The cumulative impact of COPD on mobility, independence, and overall well-being makes it one of the most burdensome chronic diseases globally.( 3 , 7 , 8 ) Given its high morbidity and associated substantial healthcare costs, high-quality research is essential to developing interventions that reduce hospitalizations, enhance symptom control, and improve patients’ quality of life. Investigating innovative treatment strategies—such as digital monitoring, personalized therapy, and mobile treatment platforms—can help improve disease management and quality of life if they are adopted by clinicians and patients.( 9 – 12 ) While common outcomes measured in COPD research assess disease progression, treatment effectiveness, and patient well-being, symptom burden and patient-reported outcomes (PROs) are increasingly recognized as critical measures, capturing aspects such as dyspnea severity (e.g. the Modified Medical Research Council (mMRC) scale), chronic cough, sputum production, and fatigue.( 13 , 14 ) Health-related quality of life is measured by validated tools like the COPD Assessment Test (CAT), which evaluates how the disease affects daily life, mobility, and emotional well-being.( 13 , 15 ) Additionally, exercise tolerance and physical endurance are measured using tests like the six-minute walk test (6MWT).( 16 ) Emerging digital health tools and remote patient monitoring are also enabling the collection of biometric and behavioral data, such as oxygen saturation trends, activity levels, and medication adherence.( 9 , 12 ) Prior studies evaluating patient perceptions of outcomes in COPD management show that breathlessness, fatigue, and the ability to engage in daily activities are prioritized over traditional physiological markers such as lung function.( 2 , 17 ) However, there remains a limited understanding of what matters most to patients in the design and measurement of COPD research.( 6 ) Despite the growing emphasis on patient-centered investigation, little is known about how individuals with COPD perceive study designs, measurement strategies, and intervention acceptability. The gap in knowledge regarding patient priorities in research design highlights the need for further investigation into how COPD studies can better align with patients’ preferences, ensuring the research is fulfilling, and the results are meaningful, and generalizable to persons living with COPD. Given the daily burden on patients living with COPD, determining the selection of meaningful outcomes in research is critical to improving care. Patients are more inclined to adopt new treatments, technologies, or care models when they see clear benefits aligned with their health priorities.( 18 , 19 ) For example, if research focuses solely on improving lung function but neglects to measure improvements in breathlessness— a symptom that significantly impacts daily living—patients may be less likely to embrace the intervention, even if it is proven to be clinically effective.( 2 , 6 , 20 ) If an intervention is designed with patient input, it is more likely to be acceptable, feasible, and usable in daily life.( 13 , 18 ) Including patients in research design also helps ensure successful clinical trials; interventions designed with patient perspectives in mind are more likely to successfully meet recruitment goals, retain participants, and yield high-quality data.( 19 ) Patients bring lived experiences to research design that highlight challenges and priorities investigators might overlook. The objective of this study is to describe patient priorities in the design and execution of clinical trials evaluating novel interventions for COPD treatment and care delivery. METHODS Study Design and Setting This study utilized qualitative methods to obtain and analyze data from stakeholders through semi-structured interviews. The theoretical framework of acceptability (TFA) was used to organize the study’s interview guide and top-level codebook.( 21 ) TFA consists of seven component constructs: affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy, and is used to evaluate partners’ perspectives on interventions before, during, and after participation.( 21 ) The study staff was based at an urban academic tertiary care medical center in the northeastern United States that serves urban, suburban, and rural communities. The institution has numerous active and recently completed clinical trials of interventions related to COPD treatment and care delivery. This study complied with the consolidated criteria for best practices in reporting qualitative research and was approved by the Institutional Review Board of the affiliate medical school (IRB Docket#: STUDY00000126).( 22 ) Selection of Participants Sampling was performed regionally, purposefully recruiting patients with a diagnosis of COPD and their caregivers. Some had recently participated in a clinical trial with an intervention focused on COPD care and treatment; others had not participated in a clinical trial. All participants were recruited via email. Participants were offered a $50 gift card for their participation. The study team intentionally balanced new invitations to sample a balanced demographic distribution of participants by age, sex, race, and ethnicity. Recruitment ceased when thematic saturation was reached. Participants had no preexisting professional relationship with the staff conducting the interviews. Data Collection The interview guide was organized by the TFA domains and informed by recent literature about COPD outcomes.( 13 , 17 , 21 ) The interview guide was piloted with 2 “test participants” and revised before use with actual participants. Interviews began with general questions about participants’ experiences with their COPD and any prior clinical trial experience. Subsequently, participants were asked more specific questions about their experiences and perspectives towards different parts of clinical study design, including recruitment, the intervention, data collection instruments, measures, outcomes, compensation, and offboarding. The context of the participants’ COPD diagnosis was emphasized (e.g., outcomes of importance in the perception of their COPD severity). The content and focus of each interview varied with the interest of the participant. The guide contained both open– and closed-ended questions with additional probes to be used at the discretion of the interviewer. The guide was refined iteratively throughout the study based on the content and focus of interviews, and the final version is included in Appendix I. The study team conducted private, 60-minute, semi-structured interviews with participants via video-teleconferencing between October 2024 and March 2025. Interviews were performed by one physician, one research scientist, and two research assistants experienced in qualitative methods and structured interviewing techniques. Interviews were audio recorded and transcribed using Otter.ai artificial intelligence software (Mountain View, California). Subsequently, the transcript was reviewed by a member of the research team for accuracy, and all identifying information was removed before analysis. Analysis Demographic data was summarized with descriptive statistics. Interview transcripts were imported into Atlas.ti (23.2.0, Berlin Germany) qualitative analysis software for coding. The study team developed an initial top-level codebook based on prior literature and organized by TFA domains. Two team members conducted a line-by-line review of five randomly selected transcripts, applying codes deductively based on the initial codebook. Simultaneously, the study staff used an iterative, constant-comparative approach to identify recurring patterns and inductively capture emerging themes, which were then incorporated into the refined codebook. Krippendorff’s alpha (a) was calculated after the first five transcripts were coded and found to be 0.86, demonstrating valid reliability between coders.( 23 ) Transcripts were coded by five members of the research team, including a physician and a research scientist with expertise in qualitative analysis, as well as three research assistants formally trained in qualitative coding and analysis. Each transcript was coded independently by two team members, after which all coded transcripts were collectively reviewed. Discussions continued until a full consensus was reached on the finalized codes. Following each consensus meeting, transcripts were re-coded using the revised codebook to incorporate refinements. This process continued until no new themes emerged, indicating thematic saturation. Once coding was complete, the themes from qualitative interviews were mapped onto a Fogg Behavior Model (FBM) graph to illustrate how various factors influenced patient behaviors.( 24 ) The FBM is a psychological framework that explains behavior as a function of three key elements: motivation, ability, and prompts.( 24 ) According to the model, behavior occurs when an individual has sufficient motivation, the ability to act, and an external or internal prompt that triggers it. Interview themes were categorized based on these elements to visualize how barriers and facilitators influence patient engagement with COPD-focused clinical trials. This approach provided a structured way to identify potential leverage points for improving patient engagement while designing COPD-focused research interventions. Patient Personas To contextualize patient perspectives and better understand how individual experiences shape attitudes toward COPD research, we developed individual profiles for each participant.( 25 , 26 ) These profiles were constructed using demographic information, clinical history, disease severity, healthcare utilization patterns, and qualitative insights from interviews. By integrating these elements, we aimed to capture the diverse backgrounds and lived experiences that influence participant views on clinical trial design, outcome measures, and participation barriers. RESULTS The study team approached 41 prospective participants and completed 15 interviews (37.5% response rate). Participant demographics are summarized in Table 1 . Analysis of participant interviews identified several key themes related to their experiences, perceptions, and priorities toward research participation, outcome relevance, and engagement. View this table: View inline View popup Table 1: Participant Demographics (N=15) Theme 1: Patients prioritize measures and outcomes that are directly relevant to their daily lives and lived experiences Subtheme: Patients were focused on their physical capacity to participate in day-to-day life Patients emphasized the importance of research measuring outcomes that directly impact their day-to-day lives, including the physical capacity to complete tasks of daily living and promote their overall sense of normalcy. Many expressed frustration with clinical measures that failed to reflect their lived experience (e.g. pulmonary function tests) or measured things in aggregate, long-term metrics (such as hospitalizations over a year). Patients consistently valued practical markers of physical function as a high-priority outcome measure, such as the ability to move a certain distance or complete a specific task. A patient noted: “It’s…being able to go in the shower…that is a good day. I can’t ambulate much without shortness of breath. So, a good day for me is just being able to do the things that I like to do…a good day for me is just not being sick, being able to breathe…Every day is different with COPD” (Participant 11, Female patient). Patients also noted that measures and outcomes should be communicated in clear, accessible language to improve understanding and reduce anxiety during their participation. Subtheme: Evaluating Mental health metrics is paramount Patients and caregivers frequently identified mental health and well-being as being of great importance when considering the impact of their COPD diagnosis. They noted that the severity of their COPD-related symptoms and the perceived burden on their lives and those of their families were central to their overall sense of well-being. They noted that they preferred measures of overall mental health rather than surveys specific to COPD-related distress. Patients indicated that COPD-specific screeners may fail to capture certain ways in which the disease impacts them. For example, patients expressed concern about how their families and caregivers are burdened with their disease, as well as fear around the unknown regarding their future quality and quantity of life, which are not captured by many commonly-used COPD-focused surveys. One participant stated, “It’s not just how I feel…it’s how I feel about how I feel” (Participant 12, Male patient). Patients also noted that emotional distress could influence overall adherence to pulmonary rehabilitation or other investigative interventions. One participant stated, “You know, how does stress fit into all of this? It isn’t just about how you feel because you are having trouble breathing, but what’s going on with the whole-body experience, which includes the mind. So how do you motivate somebody that’s having to do all these exercises and has other things on their mind?” (Participant 9, Male patient). Participants felt that supporting, monitoring, and measuring mental health may help improve the success of interventions and allow investigators to contextualize other data, including study adherence and retention. Subtheme: Metrics of caregiver burden should be included in research The role of caregivers was highlighted as patients emphasized that their condition placed a burden on family members, reinforcing the importance of research addressing both patient and caregiver needs. Concern about caregiver burden also had a direct impact on patient well-being. Patients perceived that caregivers and family members were not often engaged when measuring the impact of an intervention, despite them being very involved in managing patients’ COPD. One caregiver noted, “I am anywhere from his part-time to full-time caregiver, depending on the state he’s in. So, we have some good days, and then we have not good days” (Participant 15, Female caregiver). Participants noted they would prefer that caregivers be directly evaluated both in how much an intervention burdens them (e.g., driving patients to appointments) and how its impact changes their overall perception of how their loved one’s COPD symptoms impact them. Subtheme: Patients want study data to cross over to their clinical providers expeditiously There was a strong expectation that any real-time data collected in a study should be shared with healthcare providers. Many participants expressed frustration that data being collected for research, particularly if potentially clinically meaningful, was not made available to the clinical team in a timely way, if at all. They emphasized that integrating research data into routine healthcare visits immediately could improve patient-provider communication and offer early interventions for worsening symptoms, which appealed to them as an incentive for participating in the study, particularly given the limited access they have to their physicians. Patients felt that this was particularly important in the context of COPD because of the speed with which exacerbation symptoms can start and worsen. Example quotations from all subthemes are summarized in Table 2 . View this table: View inline View popup Table 2. Theme 1: Patients prioritize measures and outcomes that are directly relevant to their Theme 2: Study Designs that optimize engagement from patients with COPD will determine data quality The burden on participating patients should be considered in the intervention design Participants highlighted several factors that influenced their willingness to participate and remain engaged in studies. The physical burden of participation was a key concern, with most perceiving that virtual participation made research more accessible. Because COPD limits physical activity, patients expressed reluctance towards participating in interventions that required travel outside of their existing clinical appointments. Participants also discussed that interventions that allowed them to participate from home were easier to adhere to and often more comfortable because they had access to their home environment and didn’t worry about sensitivity to the environment: one participant stated, “You have maybe a good, maybe one to two months…in New England that a COPD patient can go outside, because when it starts getting too hot and humid, they can’t breathe. So, it’s, it’s, it’s hard because of the weather as well, because do you have the heat, the cold, the viruses…They’re scared. They don’t want to leave the house. They’re afraid to get sick” (Participant 13, Female caregiver). In addition to the physical burden, patients frequently expressed that cognitive barriers, such as having to use sophisticated technology or multiple devices to participate in studies, dampened their enthusiasm to participate, and they appreciate simple interfaces with fewer onboarding steps in addition to robust support from research staff to navigate study procedures. Long-Term Relationships Enhance Engagement Participants universally identified sustained relationships with research personnel as a major factor in establishing and maintaining engagement in studies. Ongoing connection was perceived as a sign of genuine investment not just in data collection but also in participants’ well-being, therefore reinforcing their willingness to engage in research. Patients want to be empowered to understand their data and use it to make decisions Many participants expressed a desire for immediate feedback on their health status during the study, particularly regarding symptom fluctuations and potential exacerbations. In studies where clinical data is being collected frequently, participants valued having results and their clinical meaning shared with them longitudinally so that they could understand the potential implications on their health. Additionally, patients voiced disappointment when they did not receive summaries of their individual progress or study results, stressing the importance of ensuring that research participation is a two-way exchange of information. When asked why being empowered to see and understand their data from studies was important to them, participants shared that they wanted to incorporate meaningful findings into any important COPD-related healthcare decisions. Participants also wanted to alleviate anxiety about whether the findings portended worsening illness. Example quotations from all subthemes are summarized in Table 3 . View this table: View inline View popup Table 3. Theme 2: Study Designs that optimize engagement from patients with COPD will Theme 3: Patients want to break down the “fourth wall” of research to be involved as partners in the research process Patients with COPD care deeply about advancing knowledge and treatment of their disease A unifying theme voiced by nearly every participant was a desire to be a part of improving how the scientific and healthcare communities evaluate and treat patients living with COPD. Participants noted that they often feel limited in their role in society because of the physical limitations posed by their COPD. However, they felt empowered by being uniquely positioned to be able to help advance the field of COPD research. They expressed optimism that participating in clinical research studies would directly improve their care and the care of others living with the disease. Patients feel more deeply connected to healthcare through study participation For many participants, research participation deepened their sense of connection to the healthcare system and other patients. Some noted that engaging with a structured study helped them feel more supported, informed, and empowered to manage their disease. The ability to interact with healthcare providers, researchers, and patient communities reinforced their engagement in their care, underscoring the potential for research to serve as an extension of healthcare delivery rather than an isolated experience. Several participants noted that the transition out of their clinical trial activities, when the study ended, was particularly challenging, citing that they felt like they were removed from something longitudinal, meaningful, and useful in providing clinical resources and support. Example quotations from all subthemes are summarized in Table 4 . View this table: View inline View popup Table 4. Theme 3:Patients want to break down the “fourth wall” of research to be involved as partners in the research process Participant Profiles Participant profiles are depicted in Supplemental File 1. Across participants, several common themes emerged, including the importance of increased self-efficacy in disease management through research participation, a desire for the pragmatic use of personal health data, and a need for ongoing engagement and support during and after the study. Many participants attributed their improved health awareness and early detection of complications to participation in studies. However, technical difficulties, lack of clear instructions, and challenges with study follow-up were frequent barriers to engagement. Another notable theme was in the transition out of the study, with many participants reporting a sense of loss or disconnection when structured support ended. Many reported that the study provided a sense of community, improved symptom management strategies, and increased their awareness of COPD self-care techniques. One major variance was in participant engagement with digital health interventions. While some participants were highly motivated and tech-savvy and reported easily integrating wearable devices and digital coaching into their routines, others found technology burdensome or difficult to use. Some struggled with understanding medical data, while others expressed frustration with the lack of real-time feedback or clear integration with their ongoing care. Additionally, perspectives on virtual versus in-person support varied. For example, some participants valued the convenience of virtual pulmonary rehabilitation, while others felt that in-person sessions were more effective for maintaining motivation and engagement. Caregivers also provided distinct perspectives, highlighting the emotional and logistical burdens of managing COPD care for a loved one. Many expressed a need for better caregiver support and integration into research and healthcare planning. Discussion COPD is a debilitating and common disease; advancements in prevention, treatment, and care delivery are needed to combat its morbidity. Engaging with participants living with COPD and understanding their priorities will help ensure that studies are more relevant, patient-centered, and yield higher-quality data.( 19 , 27 ) The present study explored the perspectives of individuals living with COPD and those assuming the caregiver role regarding research design, outcome measurement, and study engagement. Our findings underscore the importance of ensuring that studies measure outcomes that meaningfully reflect patients’ lived experiences, implement interventions that minimize participation burden while maximizing perceived benefit and clinical applicability, address patients’ physical and psychosocial needs, and include them as meaningful scientific partners. A central finding in this study was that patients prioritize outcome measures with tangible relevance to their daily lives. While traditional COPD research often emphasizes clinical metrics such as lung function, participants expressed a strong preference for measures that capture symptom burden, emotional well-being, and caregiver impact. These findings reflect previous survey-based studies of patients living with COPD, which indicated that relieving breathlessness and increasing exercise capacity, as well as mitigating patient anxiety and depression, were of primary importance.( 28 , 29 ) Many participants described how their ability to perform daily activities and maintain independence dictated their quality of life. However, unlike the narrower COPD-specific measures such as CAT, investigators should consider more holistic instruments that capture overall mental health and quality of life. This finding expands on previous investigations by clarifying that mental health should be evaluated independently of COPD-related distress. Additionally, measuring “indirect” outcome measures such as caregiver burden may provide a more holistic insight into the broader effectiveness of interventions. While previous studies have shown that more severe COPD is associated with higher caregiver burden, less is known about how interventions targeted toward COPD management impact caregiver burden.( 30 ) Another key theme was the belief that data collected during clinical trials should be actionable and integrated into routine care concurrently, if possible. Participants expressed frustration that study-generated data, even when potentially clinically relevant, was not always shared with them or their healthcare providers. They viewed real-time health insights as both an incentive for participation and a tool for proactive disease management. These findings suggest that integrating biometric monitoring, symptom tracking, and patient-reported outcomes into clinical workflows during pragmatic trials could enhance overall disease management and patient satisfaction. This preference is significant in COPD research, where patients’ clinical status can change quickly, and frequent acute care needs are a hallmark of the disease. This finding should be interpreted with caution: in many cases, participants are notified in advance that clinical data are observed but not communicated because the clinical implications of the data are unknown. Additionally, one must consider the potential for influencing study outcomes and confounding data by sharing study-based clinical information with patients in real-time. Investigators should consider a shared decision-making approach to managing study data, and prioritizing making interpretable data available but also proactively sharing it with the relevant clinical teams so that it can be incorporated into clinical decision-making when applicable. In addition to outcome selection, participants reported that study interventions designed to be accessible to patients living with COPD play a crucial role in engagement. Patients discussed the physical burden of participation, emphasizing that research should accommodate the mobility limitations and fatigue associated with COPD. Many preferred virtual or home-based participation options to reduce logistical barriers, a finding consistent with a larger body of research supporting remote and hybrid models of clinical trial engagement.( 31 ) Additionally, sustained relationships with study staff were identified as a major factor in establishing and maintaining effective participant engagement. Participants recalled that personalized check-ins and ongoing communication fostered trust and motivation, reinforcing the importance of long-term participant-researcher relationships in study retention. Finally, patients expressed a desire to be partners, rather than just participants, in research studies, moving beyond being passive study subjects to active contributors. They wanted to understand how their data was being used and to see and interpret the direct impact of their participation on scientific discovery and patient care. Many participants viewed research as an opportunity to contribute to the broader COPD community, expressing a sense of purpose and empowerment in advancing knowledge and improving care for themselves and future patients. These findings support the growing emphasis on patient-centered research approaches, which position participants as partners in the research process. Study teams might consider including patient co-investigators and advisory boards and conducting design studios during all phases of investigation. The user profiles developed during the study highlighted the heterogeneity in patient experiences with COPD and their varying priorities for research engagement, highlighting the need to actively involve a variety of patients in COPD research design to capture their diverse needs. However, despite the variation in perspectives, the profiles further underscored several central themes elicited in the interviews, emphasizing the need for personalized, patient-centered approaches in COPD research, ensuring that technologies and study designs align with individual capabilities, preferences, and long-term support needs. Limitations This study has several limitations. The results of this qualitative project are intended to provide context to observational information and not establish causation.( 32 ) Findings should not be interpreted as comprehensive or externally generalizable. Participants were recruited from a single region, which may limit the applicability of findings to broader COPD populations, particularly those in non-urban or resource-limited settings.( 33 , 34 ) Thus, their perspectives may not fully reflect the views of individuals who are hesitant or unwilling to participate in clinical research studies. The study was limited to English-speaking patients and may not reflect the values of all communities. Future studies should aim to deeply explore the perspectives of traditionally underrepresented groups and individuals with more severe COPD, as well as examine strategies for engaging those who are less likely to enroll in clinical studies.( 35 ) Conclusions This study emphasizes the need for patient-centered COPD research that prioritizes meaningful outcome measurement, minimizes participation burdens that preclude participation in research studies and clinical trials, and fosters ongoing engagement. Patients underlined the importance of measuring functional capacity, emotional well-being, and caregiver burden, ensuring that study data are not only actionable and clinically relevant but also proactively facilitating the translation of evidence into clinical adoption. As COPD research continues to evolve, active patient involvement in study design and execution will be essential to developing interventions that are both effective and widely implemented. Data Availability All data produced in the present study are available upon reasonable request to the authors Download figure Open in new tab Download figure Open in new tab Download figure Open in new tab Download figure Open in new tab Supplemental File 1: Profiles of each participant were created to represent their perspective towards COPD-focused research including key barriers and facilitators to engagement. Appendix I: Interview Guide Introduction/Verbal Consent Hello, my name is _____________, and I am a part of the research team at [lab conducting the study]. We are conducting Zoom interviews with patients living with COPD and their caregivers. Your participation in this interview is completely voluntary, and you can choose not to participate or answer any questions that I may ask you. The information we discuss will be confidential and not a part of your medical record. We will use the information we gather to understand how to better support future participants when they join a clinical research study about COPD. Are you still interested in participating? The interview should take no more than 45 – 60 minutes. Okay, let’s begin. Welcome Thank you again for coming and taking the time to participate in this project The purpose of this project is to explore your experiences and preferences about research that studies how we treat and manage COPD. We are interested in your reflections on the different components of the studies and how they made you or might make you feel or how they did or could impact your life. This information is being collected with the goal of improving how we conduct research studies and care for patients like you in our community. We want to make sure we understand all of the things that are important to a person living with COPD when thinking about research studies. We’d like to learn more about what you care about as a patient/caregiver of a patient living with COPD and what you think is less important. This is a qualitative study where the structured interviews will be analyzed for common themes and ideas between different participants. There are no right or wrong answers. Ground Rules This interview is purely for research purposes. It will have no impact on your health care. We are recording the conversation so that we can transcribe it later There is no silly question or response, and everything said in this room is confidential When we publish this project, no identifying information will be published regarding any individual person You may choose not to answer any question at any time, and you may leave at any time. Your participation is entirely voluntary. Interview Questions 1. Overall Experience- Patients Only 2. When you think about your COPD, what day-to-day things are most important to you? ○ Prompt: Is there a certain activity or task that helps you know how your COPD is doing that day? 1 . Prompt: ease of getting up stairs or completing a routine task? 2 . What does a good day living with COPD look like to you? 3. What does a good week living with COPD look like to you? 4. What does a good month living with COPD look like to you? 5. What does a good year living with COPD look like to you? ○ Prompt: If you had to focus on one activity to maintain, what would that be? ○ Prompt: How can you tell that you’re doing “really well”? 6. Overall Experience- Caregivers Only a. In your role as a caregiver, what kind of burdens did you experience while trying to manage your X’s disease? b. What types were hardest for you? c. Were there times/years in her disease that were easier or harder for you? (ebb and flow depending on exacerbations, harder as the disease progressed, easier because more comfortable) 7. Study Participation (Previous study participants only) a. How are you doing since you participated in the study? b. How was your overall experience with the study? c. Did the study have an impact on your day-to-day life? If so, how? ○ Prompt: What aspects did you find most helpful or challenging? ○ Prompt: Were there any specific changes in your daily routine? d. After the study, did you feel more confident about managing your COPD? Did the study help you with this? ○ Prompt: Can you give examples of how your health management changed? e. Based on your experience with the study, what do you think we should focus on in future research to better help patients? f. How did you first hear about the study? ○ Prompt: what made you first interested in participating in the study? ○ Prompt: Was it through a healthcare provider, friend, or another source g. What did you think of the instructions while you participated in the study? ○ Prompt: Were there any specific instructions you found confusing or helpful? h. What did you think about the recruitment process? ○ Prompt: Were there any things that made you feel comfortable or uncomfortable? Confusing or straightforward? How did signing up for the study go? Easy? Difficult? ○ Prompt: if you were to design the study for people like yourself, how would you reach out to people? How would do outreach to your friends/people you know with COPD? ○ Prompt: Is there another way you would prefer to learn about research studies ○ e.g. through your physician or in the patient portal? i. Did your study have an app? ○ Prompt: If yes: Did you find it (the study app) helpful? Were you able to navigate the app easily? ○ Prompt: What features did you find useful or challenging? ○ Prompt: Did you encounter any difficulties while using the app? If so, can you describe where you felt stuck? j. What did you think of the language of any surveys or instruments? ○ Prompt: Were they too long? Was the language used easy to understand? ○ Prompt: What aspects of the surveys were particularly challenging? k. Did the study team provide support if you needed help with the study? 8. Virtual versus in-person participation (Facilitator should prompt: sometimes interventions are offered in person, like in a hospital or clinical, or at home, through a video or app on your phone. One example of this in COPD is pulmonary rehabilitation. a . Have you used a virtual program? (if not, can skip remained of section) b . How was your overall experience with the program? ○ Did you have any hesitations or excitement about participating? c . Before starting the digital or virtual, what were your expectations or concerns about that type of program? ○ Prompt: What were the most valuable aspects of this program for you? How do you feel after using the program? Does anything specific come to mind? d. Did you face any challenges during the digital program? ○ Prompt: Were there moments when you felt uncomfortable? ○ Prompt: were there components of the technology that made it difficult for you to participate in the activities e. How did you feel about your program being digital? ○ Prompt: would you have preferred that it be in person ○ Prompt: What are the pros and cons of digital versus in-person services like telepulmonary rehabilitation? 9. Participation and Withdrawal a. What might make you withdraw from a research study? Why? b. Was there ever a time you felt like withdrawing from the study? a . Prompt: Did you find it difficult to manage alongside your other commitments? 10. Offboarding and Future Participation a. If you have participated in a clinical research study, how was the offboarding process (stopping the study) experience for you? ○ Prompt: Did you feel prepared to transition out of the study? ○ Prompt: If you were to conduct a study like this, how would you let participants know their participation in the study was coming to an end? b. Would you encourage your family or friends to participate in future studies? ○ Prompt: What factors influence your decision to recommend or not recommend participation? 11. When thinking about studies you have participated in, in your opinion, where do you think we need to improve, and what do you think we are doing well? a. Prompt: Can you provide specific examples for both? 12. One of our goals is to have study participants more actively involved in not just doing the study activities (like wearing a Fitbit or answering surveys), but also designing the study. 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Share “A Good Day Is Just Being Able to Breathe”: Aligning COPD Research with Patient Needs, a Qualitative Study Laurel O’Connor , Julia Ferranto , Anuska Ganesh Harne , Leah Dunkel , Peter Lindenauer , Bruce Miller , Christopher Mosher , Fernando Martinez , Apurv Soni medRxiv 2025.03.31.25324981; doi: https://doi.org/10.1101/2025.03.31.25324981 Share This Article: Copy Citation Tools “A Good Day Is Just Being Able to Breathe”: Aligning COPD Research with Patient Needs, a Qualitative Study Laurel O’Connor , Julia Ferranto , Anuska Ganesh Harne , Leah Dunkel , Peter Lindenauer , Bruce Miller , Christopher Mosher , Fernando Martinez , Apurv Soni medRxiv 2025.03.31.25324981; doi: https://doi.org/10.1101/2025.03.31.25324981 Citation Manager Formats BibTeX Bookends EasyBib EndNote (tagged) EndNote 8 (xml) Medlars Mendeley Papers RefWorks Tagged Ref Manager RIS Zotero Tweet Widget Facebook Like Google Plus One Subject Area Respiratory Medicine Subject Areas All Articles Addiction Medicine (567) Allergy and Immunology (863) Anesthesia (297) Cardiovascular Medicine (4411) Dentistry and Oral Medicine (443) Dermatology (380) Emergency Medicine (606) Endocrinology (including Diabetes Mellitus and Metabolic Disease) (1505) Epidemiology (15205) Forensic Medicine (30) Gastroenterology (1119) Genetic and Genomic Medicine (6574) Geriatric Medicine (666) Health Economics (994) Health Informatics (4511) Health Policy (1365) Health Systems and Quality Improvement (1608) Hematology (537) HIV/AIDS (1263) Infectious Diseases (except HIV/AIDS) (15903) Intensive Care and Critical Care Medicine (1103) Medical Education (620) Medical Ethics (144) Nephrology (666) Neurology (6573) Nursing (345) Nutrition (998) Obstetrics and Gynecology (1139) Occupational and Environmental Health (954) Oncology (3319) Ophthalmology (968) Orthopedics (369) Otolaryngology (420) Pain Medicine (435) Palliative Medicine (129) Pathology (662) Pediatrics (1689) Pharmacology and Therapeutics (691) Primary Care Research (710) Psychiatry and Clinical Psychology (5422) Public and Global Health (9205) Radiology and Imaging (2191) Rehabilitation Medicine and Physical Therapy (1367) Respiratory Medicine (1191) Rheumatology (593) Sexual and Reproductive Health (709) Sports Medicine (529) Surgery (709) Toxicology (99) Transplantation (288) Urology (265) (function(){function c(){var b=a.contentDocument||a.contentWindow.document;if(b){var d=b.createElement('script');d.innerHTML="window.__CF$cv$params={r:'9feb8c565b48df88',t:'MTc3OTI4MjI3Ng=='};var a=document.createElement('script');a.src='/cdn-cgi/challenge-platform/scripts/jsd/main.js';document.getElementsByTagName('head')[0].appendChild(a);";b.getElementsByTagName('head')[0].appendChild(d)}}if(document.body){var a=document.createElement('iframe');a.height=1;a.width=1;a.style.position='absolute';a.style.top=0;a.style.left=0;a.style.border='none';a.style.visibility='hidden';document.body.appendChild(a);if('loading'!==document.readyState)c();else if(window.addEventListener)document.addEventListener('DOMContentLoaded',c);else{var e=document.onreadystatechange||function(){};document.onreadystatechange=function(b){e(b);'loading'!==document.readyState&&(document.onreadystatechange=e,c())}}}})();