‘It Just Makes Sense to Me’: A qualitative study exploring patient decision‐making and experiences with prostate MRI during active surveillance for prostate cancer

Abstract Introduction Although prostate magnetic resonance imaging (MRI) is commonly used in the diagnosis, staging and active surveillance of prostate cancer, little is known about patient perspectives on MRI. Methods We performed a qualitative study consisting of in‐depth, semi‐structured interviews of patients with low‐ and intermediate‐risk prostate cancer managed with active surveillance. Interviews focused on experiences with and knowledge of prostate MRI and MRI‐ultrasound fusion biopsy during active surveillance. We purposively sampled patients who received prostate MRI as part of their clinical care, conducted interviews until reaching thematic saturation and performed conventional content analysis to analyse data. Results Twenty patients aged 51–79 years (mean = 68 years) participated in the study. At diagnosis, 17 (85%) had a Gleason grade group 1, and three (15%) had a grade group 2 tumour. Overall, participants viewed prostate MRI as a valuable tool that accurately localizes and monitors prostate cancer over time, and they considered prostate MRI central to active surveillance monitoring. We identified five thematic categories related to MRI use: (1) the experiential aspects of undergoing an MRI scan; (2) the experience of visualizing one's own prostate and prostate cancer; (3) adequacy of provider explanations of MRI results; (4) confidence in prostate MRI in decision‐making; and (5) the role of prostate MRI in longitudinal follow‐up, including an interest in using MRI to modify the timing of, or replace, prostate biopsy. Conclusion Patients value prostate MRI as a tool that enhances their confidence in the initial diagnosis and monitoring of prostate cancer. This work can inform future studies to optimize patient experience, education and counselling during active surveillance for prostate cancer.


| INTRODUCTION
Despite excellent long-term cancer outcomes with active surveillance for low-and favourable-intermediate-risk prostate cancer, patients commonly experience uncertainty when considering initial observational management. 1 Strategies that improve confidence in the assessments of cancer risk and improve communication may reduce cancerrelated anxiety, enhance patient experience and facilitate the initial selection and adherence to active surveillance. 2With excellent local diagnostic accuracy, prostate MRI is seen as a valuable tool for improving the assessments of cancer grade and stage and is now recommended by practice guidelines, including the American Urological Association guidelines, to augment risk stratification for patients managed with active surveillance. 3Prostate MRI has been rapidly incorporated into clinical practice in multiple contexts, including prior to prostate biopsy, as a tool for local staging and as a component of active surveillance. 4,5though there is much information available regarding the diagnostic and prognostic accuracy of prostate MRI, little is known about patient experiences with and knowledge of MRI imaging and its role in their treatment decision-making. 6,7Prior observational studies have found that use of prostate MRI is associated with increased use of initial observational management of prostate cancer. 8,9Furthermore, previous qualitative studies have found that patient self-perception of cancer risk and understanding of prognostic reports influence decisions to pursue active surveillance. 10,11However, the independent role of MRI in driving selection of or adherence to active surveillance is unknown.Additionally, limited guidance exists on how best to communicate prostate MRI results to patients within the context of prostate cancer care. 124][15] Despite modest performance of MRI to identify early progression during active surveillance, imaging is increasingly used in lieu of biopsy and it is unknown whether or how patients view these tradeoffs. 16Therefore, we sought to better understand patient perspectives on the role of prostate MRI during active surveillance for prostate cancer and its impact on decision-making.The objectives were to characterize patient experiences and preferences regarding prostate MRI as a component of active surveillance and to synthesize recommendations and better align practice with patient needs. 17

| Study design
This was a qualitative study exploring patient experiences related to prostate MRI and tissue-based gene expression testing during active surveillance.Unique data on patient experiences with tissue-based genomic testing have been presented separately. 18The Yale University institutional review board determined that this study was exempt (45CFR46.101(b)(2)).We report results in adherence to the Consolidated Criteria for Reporting Qualitative Research. 19

| Patient inclusion criteria and enrolment
At a single tertiary care referral centre in the Northeastern United States, we approached English-speaking patients with low-to favourable-intermediate-risk prostate cancer who were enrolled in active surveillance for prostate cancer without planned definitive treatment.Eligible patients had to have received at least one prostate MRI as a component of their clinical management.We identified patients through electronic medical record (EMR) queries and patient referrals from clinicians.To include the perspectives of patients of racial and ethnic backgrounds that are understudied in prostate cancer, we aimed to over-sample patients who self-identify as Black and/or Latino to enrich the diversity of the sample. 20We approached patients using a combination of strategies including secure EMR messages and phone calls followed by a screening telephone call to assess study eligibility, confirm clinical management with active surveillance and review the study objectives.We informed patients that participation was voluntary, that refusal to participate would not impact their clinical care and that a $50 gift card would be provided as compensation after completed interviews.

| Interview procedures and guide
We conducted interviews between January 2021 and December understanding of and insights into the research questions. 21

| Data analysis
We deidentified and transcribed all interviews and uploaded them into Dedoose (Version 4.12), a cloud-based software for qualitative research analysis.We used conventional content analysis to analyse the data, an inductive method to explore phenomena about which little is known. 22Two investigators (ML and RS) began by reading transcripts and immersing in the data.They next independently performed line-by-line coding by identifying key phrases and emergent concepts in the data.After gaining familiarity with the initial interviews, the research team began creating a preliminary coding framework, using consensus coding to agree on codes, their definitions and the code structure.ML and RS also recorded extensive memos on codes and their discussion, logging patient observations.Lastly, we constructed a matrix to depict thematic categories in relation to prostate MRI use.We shared the final analysis with several study participants to ensure that our interpretations were aligned with their experiences. 23| RESULTS

| Patient characteristics
A total of 58 patients were identified and screened for enrolment.
Twenty-one patients agreed to participate, were consented and were scheduled to interview with our team.One patient was deemed ineligible after enrolment because of a change in disease risk status and treatment plan, leaving 20 patients who matched our inclusion criteria and completed interviews.Common reasons that participation was declined included no answer to research inquiry (N = 30), or stated disinterest in participating in the research study (N = 7).We conducted 17 interviews via Zoom and three by telephone.The mean interview time was 48.2 min (range: 33-71 min).The mean age was 68 (range: 51-79) years.Two (10%) patients identified their ethnicity as Hispanic or Latino.Five (25%) identified their race as Black and 15 (75%) as White.At diagnosis, 17 patients (85%) had a Gleason grade group 1, and three patients (15%) had a grade group 2 prostate cancer.
Overall, participants viewed MRI as being important to their diagnosis, treatment decision-making and clinical management.However, experiences and perceptions of prostate MRI during active surveillance varied.We identified five thematic categories: (1) the experiential aspects of undergoing an MRI scan; (2) the experience of visualizing one's own prostate and prostate cancer; (3) adequacy of provider explanations of MRI results; (4) confidence in prostate MRI in decision-making; and (5) the role of prostate MRI in longitudinal follow-up during active surveillance.Table 1 outlines the clinical and demographic characteristics of study participants, and Table 2 provides the semi-structured interview guide utilized in qualitative interviews.A summary of thematic categories and clinical recommendations based on participant responses is presented in Table 3.

Introduction
We are interested in learning about how new types of scans and tests are used to help patients diagnosed with prostate cancer make decisions about whether they should have their cancer watched ('active surveillance') or treated.Prostate MRI and genomic testing are two new forms of testing that are designed to give more information about how aggressive a man's prostate cancer is.
As a result, they can help patients make an informed decision about being treated treatment or having active surveillance.

| Adequacy of provider explanations of MRI results
Some patients expressed a preference for greater information about their prostate MRI findings and their clinical implications.Although some patients felt that discussions about their imaging results were adequate, others expressed interest in greater detail:  So, why make this decision, which has so many risk, that it may need… So, it gave me more confidence.
PT 8: The PSA testing … I read so many articles and whatnot about how inconsistent it is and how you can't rely on it and how it's not very useful … .MRI … [has] been very important and helpful, and I have a lot of confidence in it, because again, it just makes sense to me.Some participants were reassured by the perception that they were receiving state-of-the-art imaging evaluations (e.g., 3 T vs. 1.5 T MRI).The perception that higher quality imaging provides more accurate assessments of disease status can increase confidence in selecting active surveillance.
PT 12: Then when I did go to Dr.
[X] and we went to the 3T, of course the 3T is much more magnified and it showed something different than the original MRI.
Seemingly discordant findings on prostate MRI compared with prostate biopsy (e.g., PI-RADS 5 lesion but Gleason grade group 1 biopsy) were a source of uncertainty for some participants.Additionally, although some patients felt MRI could help identify larger, more aggressive cancers or substantial changes in disease status, several reported concerns over sampling randomness, false positives or difficulties in identifying cancerous lesions: PT 9: The fact that I had the false positives is an aber-  24 As a result, these findings are aligned with prior studies that have identified associations between prostate MRI use and greater use of active surveillance for prostate cancer. 25,26e role of prostate MRI as an alternative to prostate biopsy for active surveillance monitoring was prominent among several participants.Although some felt reassured by using prostate MRI to more accurately direct surveillance prostate biopsies, others viewed imaging as equivalent or superior to biopsy and did not discuss its moderate reliability in identifying progression. 16Until more rigorous evidence is prior studies in the active surveillance population, we found that patients emphasized the need for information sources to tailor levels of detail to patient preferences and comfort level. 2 Participants identified new and evolving healthcare system-level challenges when receiving imaging reports.Delivery of imaging results via electronic health record portals heightened anxiety in some participants, particularly when they were unable to receive explanations by their physicians, similar to findings reported in cancer types. 28The Information Blocking Rule of the 21st Century Cures Act, designed to increase accessibility and portability of health data, has resulted in the near immediate release of radiology reports on patient portals.
Although these initiatives have increased transparency, our findings highlight potential impacts on patient anxiety and decisional uncertainty, effects that may be pronounced in patients with cancer.To address these concerns, healthcare systems should consider providing clear timelines when results will be discussed as well as increasing telehealth access for more timely counselling.In addition, some participants suggested the need for more concise and comprehensible information accompanying radiologist MRI reports.To improve communication, healthcare systems may also consider integrating simple, plain language summaries of actionable clinical findings and timelines for next steps.
2021 via Zoom™ (Zoom Video Communications), a secure web-based video conferencing platform, or by telephone, based on patients' access to technology and preference.At the start of the interviews, the interviewer provided patients with a summary of the study design and objectives and obtained verbal consent.Interviews were conducted by RS, a male researcher with post-graduate training in qualitative interviewing techniques and study methodology.All interviews were digitally recorded.We used a semi-structured interview guide (e.g., open-ended questions with probes) covering understanding patients' experiences undergoing an MRI, interpreting their prostate MRI results and improving communication between patients and providers.Sample questions included 'Can you tell me about your understanding of why your doctor recommended that you get a prostate MRI?'; 'Can you describe what it was like to physically have the MRI scan?'; 'How do you think that the information about your prostate MRI could have been better explained to you?'; and 'What is your understanding of what the MRI showed and how did that information shape your healthcare decision-making process?'We edited the interview guide reflectively, especially during early interviews, based on participants' Patients described physical and emotional experiences when undergoing a prostate MRI.Patients contrasted the experience of a prostate MRI with the invasiveness of a prostate biopsy.Although viewed as non-invasive, patients conveyed their experiences with claustrophobia or sensory discomfort because of the loud noise of an MRI or felt insufficiently counselled prior to the imaging test: PT 20: … the noise level that the machine makes while the test is going.It's just totally out of control regardless of the fact that you are given the little plugs to stick in your ear and also a set of headphones, that does nothing whatsoever.I mean, you feel like you're inside a trashcan and someone is beating the trashcan with a stick.However, other patients expressed a clear preference for prostate MRI as a painless and non-invasive test, especially when viewed in comparison with prostate biopsy: PT 15: I feel that MRI is a very, very crucial instrument … And it has been a very efficient, I think, better than the biopsy, which is painful.MRI, even if it is intimidating … it's not painful at all.A lack of clear guidance informing patients how to prepare for prostate MRI or what to expect during the MRI increased anxiety and confusion for some participants.Furthermore, waiting for the release of MRI reports or uncertainty about what these tests would show heightened concern about imaging findings, and its implications for their prostate cancer.PT 2: … she was saying to me, 'Did you do the enema?' Well, no one said anything to me about doing an enema.But before I went, like an hour before I left the house to go to the MRI appointment, I got on to, I think it was [X] to confirm the appointment.And [she] T A B L E 1 Clinical and demographic characteristics of study participants.Age (mean, range), years 68 (51-79) PSA at diagnosis, mean Gleason Grade, n (%)

PT 19 :
I was able to watch what was going on and he pointed out areas where he was taking it from.And[he] was very, very thorough in terms of[describing]   metastasis, of the potential for that, and the fact that my level of cancer was very low.PT 8: I would love to have seen the doctor say, 'Look, here is the picture of the MRI and the size and the location of your first one.And here it is on the second one.'Some patients were reassured by provider explanations of MRI results placed clearly in the context of their plan for active surveillance monitoring.PT 1: I was very positive about [active surveillance], because Dr. [X] took the time to explain to me exactly why it was needed and why it was so good … He says, 'With the MRI, we now use that as a road map to get to certain places that are of concern.' Tailored conversations, guided by patients' informational needs, were suggested by several patients to improve their understanding of the purpose of diagnostic technologies like MRI.As PT 12 noted, '[i]t might be good to ask the patient, "How would you like [this information] presented?"I think there's probably people want percentages, graphs, or they want something in writing, right?Or all of the above.It depends on the patient.'Several patients noted that receiving MRI imaging reports through electronic health record portals prior to discussion with their clinician increased anxiety and uncertainty: PT 9: The MRI was bad for me, because of the fact that I got the test, because they posted it to your MyChart online.And so I got the results of the MRI before I was going to talk to the doctor.Usually the doctor's the guy who tells you the bad news.And of course, resultsof biopsy, they don't post that, okay?Your doctor talks to you directly about that.But the MRI stated that there were two clinically significant areas of cancer found on the MRI.So unfortunately that was not a good experience.

3. 5 |
Confidence in prostate MRI in decisionmaking Patients generally felt that undergoing a prostate MRI enhanced their confidence in selecting and continuing active surveillance by providing greater certainty about the location and risks posed by their prostate cancer.Participants contrasted feelings of certainty with visualizing areas of cancer on an MRI with other tests, such as PSA, which they felt was subject to variation and uncertainty.At the point of initial decision-making, some patients felt reassured about the ability to localize and track their prostate cancer over time.PT 15: [My doctor] showed me some of the MRI pictures.He said that in 2018, and this was 2019.So, I could see also.So, I was convinced by those images that it was not actually growing up fast.And it made my decision even better, to see the MRI pictures … So, it was really helpful to know that comparison.To look at the different evolution through the year.MRI I think is a very powerful instrument.Because it's like showing evidence.Showing you, look, there is no growth here.
available to help understand the role of prostate MRI on long-term outcomes of active surveillance, clinicians should take note to communicate potential diagnostic limitations of MRI as a stand-alone modality or replacement for biopsy.Communication of prostate MRI planning and results shaped the selection, confidence and interpretation of MRI findings.Participants expressed the importance of clarity in delivering test results and centring discussions of prostate MRI results on their practical clinical meaning, including the suitability for continued active surveillance or the need to trigger action such as a repeat prostate biopsy. 27Limited communication about pre-MRI preparations (e.g., need for enema) and the possibility of loud noise or claustrophobia increased anxiety and distress for some patients.Therefore, prostate cancer clinicians should take note to also provide anticipatory guidance for MRI studies beyond what may be provided by radiology centres.Consistent with

4. 1 |
Study limitationsOur data are neither representative of all patients with low-and intermediate-risk prostate cancer nor immediately generalizable across treatment contexts and study populations.We aimed to enrol a diverse sample of patients both clinically and demographically for this study across racial and ethnic groups, and cancer risk strata, and academic versus community affiliation.However, our sampling frame, because of challenges with enrolment during the COVID-19 pandemic, was restricted to one academic tertiary referral centre.Considering that our study only evaluated the perspectives of patients who selected active surveillance, future studies are needed to evaluate the experiences of patients who discontinued active surveillance or sought early treatment despite having lower risk prostate cancer.As a result of the COVID-19 pandemic, interviews were conducted remotely over Zoom™ teleconferencing software or via telephone.This requirement excluded patients who lacked access to these technologies and may have affected the interviewer-interviewee dynamic.30 5 | CONCLUSIONIn this qualitative study of patients with low-and intermediate-risk prostate cancer managed with active surveillance, we found that participants held favourable views of prostate MRI and prioritized MRI to improve confidence in cancer risk assessment and its ability to track longitudinal changes over time.Patients shared a range of preferences for information about MRI results and generally emphasized the need for clearer provider discussion of findings and their potential clinical significance.
How could the information about your prostate MRI or genomic testing have been better explained to you? (Probe: Does hearing a percentage (for example an X% risk of cancer metastasizing) help you?Or would you prefer to see this information visually in a picture or graph?Would it be more helpful for your doctor to describe risks using words like 'the risk is high' or 'the risk is low' be better?What remaining questions, if any, do you have about your test results?Are there any unresolved questions?)7How would you feel about using an electronic survey to help your doctor understand your preferences about discussing risk estimates?Would you want to complete this before your visit with your doctors or discuss it with them directly?Summary of thematic categories and clinical challenges identified by patients with potential strategies for practice improvement.
1Thinking back, what was your experience like in choosing active surveillance rather than some other treatment such as surgery or radiation?(Probe:Whohelpedyoumakethat decision?What was important to you?)2Deciding about active surveillance or treatment for prostate cancer usually involves a lot of discussion about the risks and benefits of each approach.Can you tell me about how information about the risks of your prostate cancer was presented to you? (Probe: Did you find it to be effective?Was there anything that you found to be confusing?)3Iunderstandthat you had a prostate MRI as part of your evaluation.Can you tell me about your understanding of why your doctor recommended that you get a prostate MRI? 4 What is your understanding of what the MRI showed and how did that information shape your healthcare decision-making process?(Probe:In what ways did getting the MRI alter, if at all, confidence in your decision?In what ways did MRI alter, if at all, your level of anxiety about the diagnosis, or the decision to move ahead with active surveillance?) 5 How was your overall experience with having the MRI scan?(Probe: How did you feel leading up to it, and at the time?Did you feel prepared?[Ifanxiety/noise/discomfort:howdid you cope with them?]How do you think the experience of the test itself could be improved?)68Asyou know, active surveillance involves close monitoring of prostate cancer.Is having a prostate MRI/genomic testing a component of your monitoring plan?If so, do you think the role of these tests in the monitoring process has been explained in an effective way to you?If not, how could it be improved?Do you think a written or electronic document to track this information over time would be helpful?9Isthereanything we have not discussed that you think it is important for us to know about how new technologies can help patients with low-risk prostate cancer with decision-making?said, 'Do the prep first.'Sothiscauseda little bit of stress.PT 1: So going into the MRI … there's a little bit of that, 'Okay, am I going to get the email from MyChart today?Is it going to be the email from MyChart today?'And when I do, when I'm looking at, what does it tell me?Because obviously, the terms, in there were things that I was, 'Okay, it says this.What is this?' I would then 3.3 | Experience of visualizing prostate and prostate cancer By visualizing the prostate, the location and dimensions of suspicious prostate lesions, some patients found MRI to be an informative tool for understanding their prostate cancer diagnosis and recommended clinical management: PT 2: any information on the structure of what's being seen in the prostate, exactly where the lesion is … I would find helpful.givemeasmuch information as you can.Some patients found that visualizing one's own prostate imaging during MRI-ultrasound fusion biopsy enhanced feelings of agency in their prostate cancer care:T A B L E 3