Exploring patient‐reported outcomes following percutaneous coronary intervention: A qualitative study

Abstract Background Percutaneous coronary intervention (PCI) is a common cardiac procedure used to treat obstructive coronary artery disease. Patient‐centred care is a priority in cardiovascular health having been shown to increase patient satisfaction, engagement with rehabilitation activities and reduce anxiety. Evidence indicates that patient‐centred care is best achieved by routine collection of patient‐reported outcomes (PROs). However, existing patient‐reported outcome measures (PROMs) have limited the patient involvement in their development. Aims To identify and explore outcomes, patients perceive as important following PCI. Methods A qualitative design was adopted. Eight focus groups and five semi‐structured interviews were conducted with 32 patients who had undergone PCI in the previous 6 months. Outcomes were identified and mapped under the U.S. Food and Drug Administration (FDA) patient‐reported outcome (PROs) domains of feeling (physical and psychological outcomes), function and evaluation. Inductive and deductive analysis methods were used with open, axial and thematic coding. Results Consistent with prior studies, patients identified feeling and function outcomes such as reductions in physical and psychological symptoms and the ability to perform usual activities as important. Participants also identified a range of new outcomes, including confidence to return to usual activities and evaluation domains such as adverse effects of medications and the importance of patient communication. Conclusion The findings of this research should be considered in the design of a cardiac PROM for PCI patients. A PROM which adequately assesses these outcomes can provide clinicians and hospital staff with a foundation in which to address these concerns or symptoms.

New techniques may reduce pain experienced by patients, and mental well-being was rarely considered an important element of recovery during the 1990s. 15 The evaluation domain is demonstrated in prior research highlighting the relationship between procedural expectations and PROs and the importance of doctor-patient communication in perceived successful recovery. [8][9][10][11][12][13][16][17][18][19][20] PROs describing elements of cardiac rehabilitation and patient support services that aide recovery, including stress management techniques and modifying health habits, are also evaluated in the literature. 12,18 To adhere to, and achieve the benefits of patient-centred care, it is essential that PROMs accurately capture outcomes specific to the patient population. 7 Only one condition-specific PROM─the Coronary Revascularisation Outcomes Questionnaire (CROQ)─was developed using methods that captured patient's perspective.
Semi-structured interviews were conducted with ten percutaneous transluminal coronary angioplasty (PTCA) patients asking about their experiences of PCTA. A review of the literature identified 10 articles related to PROs for PCI patients: nine qualitative studies and one mixed methods study. Five studies conducted interviews; 10,12,[19][20][21] four studies conducted focus groups; 8,9,16,18 and one study consisted of semi-structured interviews and the completion of pre-existing PROMs (Illness Perception Questionnaire, Hospital Anxiety and Depression Scale and the General Health Questionnaire-12). 11 In some of these studies, the data collection has been deductive 8,9,11,18 or focused on one aspect of the patient experience such as provision of health information or the process of preparing for the procedure. 10,16,21 The deductive use of preexisting measures or focused topic areas to guide the focus groups and interviews may have restricted the researchers' ability to ask follow-up questions and limited the participants' ability to provide a well-rounded account of recovery outcomes. One study employed an inductive data analysis technique; however, there were only 11 participants in the study. 12 Interviews with PTCA patients were conducted approximately 4 weeks post-discharge. Long-term concerns arising from the procedure such as anxiety were not explored, and the study does not state at what point of PROM development PTCA patients provided input.
The aim of this research was to identify and explore outcomes patient perceive as important following PCI using inductive approaches to qualitative data collection and analysis methods.

Conclusion:
The findings of this research should be considered in the design of a cardiac PROM for PCI patients. A PROM which adequately assesses these outcomes can provide clinicians and hospital staff with a foundation in which to address these concerns or symptoms.

K E Y W O R D S
patient perspectives, patient-centred care, patient-reported outcome measures, patient-reported outcomes, percutaneous coronary intervention 2 | METHODS

| Participants
Patients aged 18 years or older who had undergone a PCI in the previous 6 months were eligible to participate. Patients who were unable to participate in a focus group due to cognitive decline or limited knowledge of the English language were excluded.
Recruitment was via four hospitals in Victoria, Australia and a private health insurer. Eligible patients were sent an invitation letter via the hospital or insurer and asked to contact the researchers if they were interested in participating. A total 1154 invitations were sent between March and August 2016 resulting in contact from 90 (8% response rate) interested patients. Thirty-four patients were ineligible to participate based on the timing of their PCI, and 14 were unable to attend a scheduled focus group or interview based on timing, location or unforeseen circumstances.
Eight participants declined to participate and two participants were lost to follow-up.

| Data collection
Eight focus groups and five interviews were conducted with 32 participants. Prior to the focus groups, participants completed questions about demographic characteristics and health status. The US Food and Drug Administration (FDA) categorizes PROs into three domains: feeling (how the patients feel physically and psychologically), function (mobility, ability to perform daily tasks) and evaluation (the patient's overall perception of the successfulness of their procedure and care). 6 Participants were asked three open questions which related to these domains: Data collection was iterative and probing questions were asked depending on the responses and the findings of previous focus groups and interviews. Focus groups and interviews were audiorecorded, and notes were made during and after the data collection encounters.

| Analysis of data
Transcripts were entered into NVIVO prior to coding. Inductive and deductive coding methods were adopted using a process of open, axial and thematic coding. Open codes were generated by looking for initially captivating concepts from PCI patients. Axial coding was conducted to connect common outcomes identified by participants. 22 Using deductive coding, outcomes that correspond to feeling, function and evaluation were identified. Inductive coding was applied to identify emerging themes from the participants not previously captured in the literature review. Coding and data analysis was conducted by two researchers (DA and DB) to increase the rigour of the analysis. DA and DB compared codes for consistency and discussed discrepancies with AB. Consensus was reached on all codes. The codes and themes were presented to all the authors for feedback.

| RESULTS
Patient characteristics are shown in Table 1. The majority of the participants were male (83%), had private health insurance (77%), lived with a partner/spouse (67%) and were retired (67%). The mean age of the participants is 70 (SD 9.1) years of age. The patient characteristics compared to Victorian Cardiac Outcomes Registry (VCOR) are shown in Table 2. The age of our sample is slightly younger; however, the proportion of females and those with a diagnosis of myocardial infarction (MI) is similar between both groups. Patients with private health insurance are substantially higher in our sample; however, this is due to recruitment occurring through a private health insurance provider.
The main themes that arose from the data have been mapped to the domains of feeling, function and evaluation. The themes are presented in Table 3 and described below.

| Feeling: physical outcomes
The feeling domain incorporates the physical and psychological outcomes patients perceive as important after their PCI. Participants While the study did not specifically aim to identify differences in preferences across men and women, it emerged that men tended to describe breathlessness in the context of an activity whereas women described breathlessness as a symptom in isolation. Participants used various terms to describe their angina: discomfort, tightness, "really bad chest pains," "chest pressure" and "continuous pain underneath the sternum." Some participants described their angina more explicitly, highlighting the severity of the pain: I felt like a hammer hit me in the chest. I've never experienced that before.

Participant 1942, M, 71
Participants who presented with a "toothache and inflammation in [the] gum" were "a little bit sceptical" when they were told by health professionals that they had angina. They were unaware that angina pre- Participants stated that they were "very exhausted" and "very tired" before their procedure; however, this improved post-procedure: I used to be quite tired for about six months prior to this and now I've worked out why I was tired. And since then, since I've had the procedure I haven't been tired at all.

Participant 0701, M, 71
The majority of participants who identified fatigue as an outcome were aged between 75 and 84 and concluded that experiencing these symptoms was unavoidable due to their age: Female interview participants provided more information relating to depression, reporting that "it did take me quite a while to recover, I did get quite depressed afterwards" and that "I still feel quite low sometimes." One participant identified a term employed by the cardiac rehabilita-

| Function
The function domain encompasses the patient's mobility and ability to maintain their regular routine. Participants were concerned that their procedure would render them "unable to do what you have to do." As a result, participants described their capabilities to do and participate in activities of daily living as a key outcome of their procedure: that they had been "fortunate enough to go to rehab" and that it "helped tremendously." Participants also thought that attending cardiac rehabilitation provided them with the opportunity to understand their experiences through connecting with others who had gone through the same procedure: It was just interesting to talk to other people who had the same problems.

Participant 0203, M, 62
The information provided in cardiac rehabilitation led to life style and behavioural changes for a number of participants.

| DISCUSSION
In this study, the outcomes patients report as important following PCI were explored. The qualitative design allowed for the in-depth study of patient experiences articulated in their own words-an important aspect in the identification and development of PROs. 6  Psychological outcomes identified were anxiety, questioning mortality and cardiac blues (depression). A unique theme identified in this study was the concept of confidence to continue with usual activities. Participants described being cautious, anxious and uncertain in their abilities after the PCI; however, their confidence increased over time. The ability to complete activities of daily living (ADLs) was the main function outcome. Evaluation outcomes related to the benefits of cardiac rehabilitation, the adverse effects of medication and the importance of patient communication.
The findings correspond and extend on the results of previous studies. 8,9,11,20 Angina is a typical outcome reported in prior studies. 10,12 However, this study highlighted the need to understand the different ways angina is experienced. Many participants described angina as discomfort instead of pain and females in particular described the sensation as reflux or heartburn. In this study, some participants did not describe depression symptoms yet highlighted that this was an issue for other patients. This sentiment was also evident in another Australian study which found that patients acknowledged that other patients may need psychological support after their procedure, yet felt they did not feel they personally require this support. 12 In this study, mental health and psychological outcomes were considered in more detail by participants in interviews than focus groups. This may be due to the privacy and perceived comfort of an individual interview, compared to the open dialogue generated in the focus groups. The generation of participants in this study are generally less mental health literate and therefore unlikely to state feelings of depression 14 .
Emerging findings from the inductive analysis revealed differences between the genders and age groups in relation to patient experiences post-PCI. Male and female participants identified similar outcomes but described these outcomes differently. Males primarily described their post-procedure outcomes within the context of performing daily activities or participating in physical activity, whereas females presented their symptoms in isolation. Age was also discovered as an emerging factor that explained differences in the narrative of symptoms. Older participants viewed many of their symptoms as an inevitable part of the ageing process, whereas younger participants viewed the same symptoms as an adverse effect of medication or comorbid conditions.
These findings are important as they can be used to enhance patientcentred care and the tailoring of health education and management strategies. Further examination of these trends is warranted in a larger quantitative study to test whether these patterns persist in a more representative sample.
Good communication between the health-care team and patients and the importance of providing information through avenues such as cardiac rehabilitation was emphasized by participants in this study.
This ability to engage with a member of the care team face to face has also been highlighted in other studies. 21

| LIMITATIONS
This study has a number of limitations. The analysis and data collection of this study did not focus on the preceding cardiac condition.
While the preceding cardiac condition does not change the type of symptoms the patient experiences, it may influence the extent and severity of reported outcomes. For example, a patient presenting with mild angina will recover in less time than a patient presenting with a myocardial infarction. Deeper exploration of elective versus emergency and private versus public patient PCI outcomes is therefore warranted. Given the unique experiences of individuals, further research on the patient experience of PCI should also extend to culturally and linguistically diverse populations.
The response rate from the invitation letters was just under 10%. This is a similar rate to other studies where cold mailing approaches have been taken to recruit participants. However, it does raise questions of whether the sample was more biased to healthier patients who felt well enough to participate. 24 The majority of participants in this study were male (78%), and therefore, the sample does not equally represent both genders. However, the sample does correspond to the proportion of male and female patients undergoing PCI in Victoria. 25,26 Despite these limitations, this study provides important new information regarding patient-reported outcomes following PCI. The The final PROM is a five-item PROM. The results of these studies will be reported elsewhere.

| CONCLUSION
Being able to perform usual activities without breathlessness, the reduction or elimination of angina pain/discomfort and improved energy and reduced fatigue were important physical outcomes for patients post-PCI. Lacking confidence in being able to undertake activities of daily living, experiencing anxiety and cardiac blues and questioning mortality were the main psychological outcomes identified. These feeling outcomes align with and extend on previous literature. A PROM which adequately assesses these outcomes can provide clinicians and hospital staff with a foundation in which to address these concerns or symptoms. An important evaluation outcome valued by participants was face-to-face communication in a format such as cardiac rehabilitation. Patient information is important to ease anxiety over side-effects of medication and to manage expectations of recovery.
Overall, patients reported a wide range of outcomes pertaining to feeling, function and evaluation post-PCI. These should be considered as an important component of tailoring patient-centred care and in the development of future PROMs.