Exploring the value of using patient-oriented MRI reports in clinical practice — a pilot study

Standard radiology reports (SRR) are designed to communicate information between doctors. With many patients having instantaneous access to SRRs on patient portals, interpretation without guidance from doctors can cause anxiety and panic. In this pilot study, we designed a patient-centred prostate MRI template report (PACERR) to address some of these challenges and tested whether PACERRs improve patient knowledge and experience. Patients booked for clinical prostate MRI were randomly assigned to SRR or SRR + PACERR. Questionnaires included multiple-choice that targeted 4 domains (understanding, usefulness, next steps, emotional experience) hypothesized to improve with patient-centred reports and short answer questions, testing knowledge regarding MRI results. Clinical encounters were observed and recorded to explore whether adding PACERR improved communication. Likert scaled-responses and short-answer questions were compared using Mann-Whitney U test and Kruskal-Wallis test. Of the 40 participants, the majority were MRI naïve (70%). Patients receiving a PACERR had higher scores in the categories of patient understanding (mean: 4.17 vs. 3.39, p=0.006), usefulness (mean: 4.58 vs. 3.07, p<0.001), and identifying next steps (mean: 1.89 vs. 3.03, p=0.003) but not emotional experience (mean: 4.18 vs. 3.79, p=0.22). PACERR participants found the layout and design more patient friendly (mean: 4.47 vs. 2.61, p<0.001) and easier to understand (mean: 4.37 vs. 2.38, p<0.001). In the knowledge section, overall, the PACERR arm scored better (87% vs. 56%, p=0.004). With the addition of prostate MRI PACERR, participants had better understanding of their results and felt more prepared to involve themselves in discussions with their doctor.


Introduction
Multiparametric prostate MRI (mpMRI) and mpMRI-fusion prostate biopsy are integral for prostate cancer (PCa) diagnosis [1]. MpMRI can direct biopsies towards lesions that are occult on ultrasound yielding more clinically significant PCa and less clinically insignificant PCa than systematic biopsy alone [2,3]. MpMRI is also used to monitor patients on active surveillance, limiting repeat biopsies [4].
To be transparent, many organizations are connecting patients to their radiology reports via online patient portals. This enhanced access to medical records can make patients feel more in control [5,6]. However, in general, the quality of online records is variable [7].
Radiology reports contain vital information that is relied on for patients and families to discuss diagnosis, treatment, and prognosis with healthcare providers [8]. While medical records have become more accessible for patients, reports are not designed for patients. "Standard" radiology reports (SRR) are intended for communication amongst doctors. Despite standardization by the Prostate Imaging -Reporting and Data System v2.1 (PI-RADS v2.1), prostate mpMRI is a case study in reports that are difficult for patients to understand [9]. This is because they contain very technical medical language, esoteric scoring, and countless abbreviations.
In fact, patient-centred communication (e.g. addressing emotional needs, managing uncertainty, explaining things clearly) has been demonstrated to improve patient emotional well-being [10]. Conversely, sharing traditional records that require high health literacy does not promote understanding and could harm patients [11]. Without knowledge to interpret reports or doctor-guidance, patients are left to speculate the implications of reports. Thus, a different approach is needed. To improve clinical encounters, several groups have proposed a workflow where patients have immediate access to augmented, patient-centred reports, in addition to the standard ones, to help transmit an appropriate amount of information with language and design intended for patients [12,13].
To address this gap, in collaboration with patients and expert groups, our team designed a patient-centred radiology report for prostate MRI (PACERR) [14]. PACERRs are individualized radiology reports with an annotated image of a prostate and explanation of any identified lesions. The aim of the current study is to test the usefulness of PACERR in a clinical setting. We anticipate that by using patient-oriented language and design, the PACERR will bring the report's content to a level where it can be better understood and synthesized by patients. Thus, we hypothesize that, in comparison to SRRs alone, adding PACERRs improves patient understanding of key findings on MRI, allows for a more patient-oriented clinic visit, and improves doctor-patient communication.

Patients and trial workflow
A prospective clinical trial in accordance with research ethics guidelines and Ontario Personal Health Information Protection Act (PHIPA) was performed with institutional research ethics approval (REB #18-6240) between June and October 2019. Patients with upcoming prostate MRIs were approached for study participation. Eligible patients were 18+, English speaking and pending prostate MRI for active surveillance, prior negative biopsy but rising PSA, or biopsy naïve with elevated PSA. After informed consent was provided, patients were alternately assigned to receive their prostate MRI report as either an SRR alone or an SRR and PACERR. Group assignment was stratified by MRI status (normal MRI vs abnormal MRI result). Basic clinicopathologic data (e.g. age, PSA, clinical state) were collected.
Individualized PACERRs were generated with Adobe Acrobat by investigators using information from the SRRs (see Figure 1, for example PACERR). Scoring rules were designated by consensus during pilot testing and used to determine various MRI results (e.g. "enlarged prostate") and tumour characteristics (e.g. "small spot" -Appendix Table 4).
There were no validated questionnaires available to assess understanding and experience with medical reports. Thus, study investigators, in collaboration with patient partners, designed a questionnaire based on patient input during prototype development. Questionnaire language and content were pre-tested with patient partners. Questionnaires included 16 multiple-choice questions that target 4 domains hypothesized to improve with patient-oriented reports (understanding, usefulness, next steps, emotional experience) and 11 short answer questions, testing knowledge regarding MRI results.
Prostate MRI reports (either SRR alone or SRR + PACERR) were emailed to patients once available. There was typically a 1-week delay between report production and the clinic visit where patients would be reviewing results with their doctor. Patients completed the questionnaire twice. The pre-visit questionnaire (Appendix Table 5) was completed within 7 days of receiving the MRI report(s), while the post-visit questionnaire (Appendix Table 6) was administered within 30 days of the clinical visit. During the clinical visit, there was also an observational component exploring doctor and patient behaviour. The observational component was scored by a clinical research assistant observing the clinical interaction, tabulating various ways reports were being used (e.g. sketching on report) and calculating visit time (see scoring table -Appendix Table 7).

Sample size calculation and statistical analysis
With 20 patients in each group, there is 80% power to detect a 10% difference between the two groups at a significance level of 5%. Study investigators selected 10% as a target difference because this was felt to represent a clinically meaningful difference and had no other guidance since the questionnaire was being used for the first time. We also felt that 20 patients would be sufficient to perform factor analysis to assess if questions were performing as expected.
Patient demographics, stratified by arm, were summarized using descriptive statistics and compared using Fisher's Exact and Mann-Whitey U tests. Factor analysis and thematic synthesis were used to organize questionnaire questions into categories. Oblimin rotation and a loading cutoff of 0.4 were utilized for the factor analysis. Cronbach's alpha was used to evaluate the Fig. 1 Prototype patient-centred radiology report (PACERR) for prostate MRI internal consistency of each group. To analyze differences in responses to the multiple-choice questionnaire, responses were coded as ordinal outcomes (1 = strongly disagree, 2 = somewhat disagree, 3 = neutral, 4 = somewhat agree, 5 = strongly agree). The group score was calculated by taking the mean of its components. Differences in response distribution between arms were visualized using density plots. Patients' understanding was quantified by assessing the ability to correctly identify spots, likelihood of cancer, and accuracy of additional findings. Multiple choice and observational data were summarized using descriptive statistics, and differences between arms were evaluated using the Mann-Whitney U test. Subgroup analyses stratified by arm and MRI positivity status were explored, and differences between subgroups were assessed using Kruskal-Wallis tests. All statistical tests were 2-tailed and p<0.05 was considered statistically significant. Statistical analysis was performed using R version 3.6.1 (R Foundation for Statistical Computing, Vienna, Austria).

Patient and clinical characteristics
We contacted 90 participants for enrolment in this study. Forty-two patients consented (enrolment rate 47%) and 2 patients withdrew (retention rate 95%). Thirty-seven participants completed the pre-visit questionnaire and 40 participants completed the post-visit questionnaire. Patient and clinical characteristics were well-balanced between groups except for age (Table 1). Most patients had no prior prostate MRI (70%). Sixty-two percent of MRIs were abnormal.

Pre-visit questionnaire: Multiple-choice
Scores for each multiple-choice question, stratified by group assignment, are presented in   In the subgroup analysis, presented in Figure 2 and Appendix Table 10, results were further stratified by MRI status (i.e. whether patients had a positive or negative MRI result). In general, the differences between SRR and PACERR groups were similar to the main analysis regardless of MRI result. However, some of the questions in the emotional experience domain demonstrated differences between the groups that were not apparent in main analysis. For example, despite similar distribution of PIRADs scored between arms, patients in the SRR arm with an abnormal MRI were significantly more likely to feel that they received very bad news compared to those in the PACERR arm with an abnormal MRI (36% vs. 8%, p=0.036). Furthermore, patients with an abnormal PACERR were significantly more likely to state that receiving their MRI report ahead of time lowered their anxiety compared with SRR patients who received an abnormal report (75% vs. 45%, p=0.029).

Pre-visit questionnaire results -Short-answer section
In the short-answer knowledge section, overall, patients in the PACERR arm scored better than patients in the SRR arm (87% vs. 56%, p=0.004). Eighty percent of participants with PACERR correctly acknowledged the presence of potentially malignant abnormality in their prostate on MRI report as compared to 38% of SRR participants (p=0.051). Eighty-four percent of patients in the PACERR arm correctly identified the likelihood of cancer in a particular spot on their MRI compared to 50% of participants who received the SRR alone (p=0.041). The proportion of patients in the PACERR and SRR arms that correctly identified abnormalities on their MRI was 88% and 67%, respectively, though the difference was not statistically significant (p=0.22).

Doctor and patient behaviours
Identified behaviours from the clinical encounter stratified by group assignment are shown in Table 3. There was no difference in the clinical encounter time between the two arms (PACERR median 7 min, range 2-27 min; SRR median 8 min, range 2-37 min). Results stratified by arm and MRI status are presented in Appendix Table 11. The PACERR abnormal report was verbally referred to by doctors significantly more than the SRR abnormal report (mean = 2.79 times and 0.9 times, respectively (p=0.027)).

Post-visit questionnaire
There were no statistically significant differences in questionnaire responses between arms or significant interactions for the post-visit questionnaire.

Discussion
PACERR prostate MRI was designed to improve patients' understanding of their MRI report, improve their experience, and enable them to interact more productively with the healthcare system. In this trial, patients undergoing prostate MRI for common clinical indications were randomly assigned to usual care with standard radiology reports versus adding an individualized patient-centred report. In this pilot study, we explored differences between groups using a questionnaire with four domains: understanding, emotional, next steps, and usefulness. In a study exploring patients' experiences with AI-generated reports, Bala et al. found that simplified notes were more carefully read, easier to understand, helped patients communicate with their family members, and made it easier to retain information [15]. Similarly, patients who received both an SRR and PACERR were more likely to report that their MRI reports were easy to understand and useful for discussing treatment plans with their medical team. Furthermore, the PACERR allowed patients to use their report as an interactive take home tool, evidenced by the fact that the PACERR was drawn and written on more frequently than the SRR. Patients in the PACERR group were also better able to determine whether there were possible sites of malignant abnormality in their reports.
The emotional experience for patients receiving medical results is complex. Jiang et al. present a conceptual framework directly linking patient-centred communication and patients' emotional well-being [10]. In their study, 2729 patients completed a patient-centred communication questionnaire following a clinical encounter. They found that patient-centred communication enabled self-management and predicted better emotional wellbeing. This was also apparent in our pilot trial. We found that patients with a PACERR and a lesion on MRI were less worried and anxious about the result compared to patients who had a standard report with a lesion. It is possible that the design, language, and targeted information present in the PACERR better prepare patients to receive difficult results.
In our study, the questionnaire was given to patients at two time points to explore whether the effects of having a PACERR vary over time. In a study by Mira et al. analyzing how and when patients post questions to health forums around the time of clinical visits, the majority of questions were found to be posted prior to clinical encounters [16]. In our study, the differences that were seen between groups when the questionnaire was administered prior to the clinical encounter (i.e. pre-visit) were not present when the questionnaire was re-administered after the clinical encounter (i.e. post-visit). By the time the post-visit questionnaire was administered perhaps patients already had the opportunity to review results with their doctors, contemplate the implications of the report, and educate themselves in other ways. Thus, it appears that the PACERR is most beneficial in the period between the publication of the SRR and the clinical encounter a time when many are seeking better understanding and clarification.
Interestingly, even though there was an additional report to review, the PACERR did not change the length of clinical encounters. Evidence suggests that clinical encounters are often not long enough to fully meet patients' needs for knowledge [16]. If the PACERR can reduce the time spent on explaining the basics of a test result and allow more time for synthesizing the information and exploring treatment options then perhaps patients will feel better educated in a similar amount of time and reduce the need for patients to book a second visit.
This study has several limitations. We limited inclusion to English speaking patients so it is unknown whether non-English speakers, a group that might benefit most from a patient-centred report, benefit from PACERR. Household income and education level are likely associated with comprehension and communication with doctors. This study contained a wealthier and highly educated population which may not be representative of the general population. Furthermore, with a small sample size, we were unable to demonstrate statistically significant differences in several domains which were hypothesized to be improved with PACERR. For example, this was apparent in the questions about lowering anxiety which showed potentially important differences in score distribution but did not reach statistically significance. Finally, non-validated questionnaires were used. We use a non-validated questionnaire because there were no validated ones available that targeted patients' experiences with medical records. Statistical assessment of the in-house developed questionnaires demonstrated good consistency and grouping. However, there are some unique strengths including using a PACERR that was developed with patient-input at every design step [14]. Also, doctors who were in the trial had no exposure to the PACERRs prior to the clinical trial, so it mimics a more real-world roll-out of such technology.

Conclusion
Through plain language and simple design, our team has created a patient-centred radiology report that increases patients' self-reported understanding and their ability to accurately identify lesions and their approximate likelihood of cancer. Participants were empowered to actively involve themselves in discussions with their doctors, communicate their results to family and friends, and think realistically about the future. Future work will focus on encompassing patient demographics not adequately represented in this study and expanding to other disease sites and pathology reports in addition to automating the creation of individualized patient-centred reports.

Prostate MRI Patient Questionnaire 1 -Pre-Visit Questionnaire
Please read your prostate MRI report(s) before answering the questions below. There may be one or two prostate MRI reports for you to look at. If you have two reports, please complete this questionnaire by considering both reports in combination. Both reports refer to the same prostate MRI radiology test that you recently had.
Your answers are for study purposes only and will not be shared with the doctor who ordered your prostate MRI nor will they be used in any way to change your clinical care. You do not have to answer anything that you feel uncomfortable with.
A. How much do you agree with the following statements: Totally disagree Somewhat disagree Neutral Somewhat agree Totally agree 1. AŌer reading the MRI report(s) I understand why my doctor ordered it for me 2. AŌer reading the MRI report(s) I understand which parts of my prostate might have cancer 3. AŌer reading the MRI report(s) I understand the chances that each spot might have cancer 4. AŌer reading the MRI report(s) I understand whether there is concern that cancer has spread beyond the prostate 5. AŌer reading the MRI report(s) I feel that I have received very bad news 6. AŌer reading the MRI report(s) I think that I will definitely need a prostate biopsy 7. AŌer reading the MRI report(s) I think that the results will change the treatment opƟons available to me 8. Overall, I believe that the content of this MRI report is useful for discussing next steps with my doctor 9. Overall, I believe that the content of this MRI report is useful for communicaƟng the results to my family and friends    Table 8 Exploratory factor analysis loadings. Factor analysis was conducted using oblimin rotation and a factor loading cutoff of 0.4. The analysis was repeated separately for both the pre-visit and day of visit data. Three factors were chosen as per results of the scree plot

Question
Pre-visit Day of visit

Declarations
Ethics approval REB approval and institutional authorization were obtained by University Health Network Research ethics board committee prior to the conduct of this study. This study was performed in line with the principles of the Declaration of Helsinki.
Consent to participate All participants were made aware of the study risks, benefits, and procedures prior to participation and consent was obtained for all participants. Participants were given ample time to contemplate the decision to participate and could withdraw at any time without consequence. Participants consented to anonymous transcripts being produced and used for publication purposes.