PILOT STUDIES AND DATA SOURCES
Details of the pilot trials have been described previously and are summarized in Fig. 1 [12, 13, 14, 15]. In brief, PCPR templates were iteratively developed for each organ site via multidisciplinary input from clinical experts (oncology, surgery, pathology), researchers, and patient advisors. The team then led four separate pilot randomized controlled trials to evaluate the impact of PCPRs on patient knowledge of their pathology and experiences with cancer decision-making (primary results reported elsewhere for each trial). Each pilot trial recruited patients with new cancer pathology and patients completed semi-structured surveys at two timepoints: initial receipt of pathology reports (standard pathology only for the control group, standard pathology and PCPR for the intervention group), and 30 days later. Pilot trials occurred for PCPRs developed for bladder cancer (2016), prostate cancer (2019), breast cancer (2020) and colorectal polyp (2021). A total of 228 patients were recruited across all four pilot studies. Recruited patients had no prior cancer diagnosis, were English-speaking, and over 18 years of age.
The objective of this analysis was to leverage lessons learned from all four pilot trials to identify common barriers and facilitators that can support future efforts to disseminate PCPRs in care delivery settings. Our analysis was guided by the RE-AIM framework, an established implementation science framework used to guide evaluation efforts at any stage of implementation [16]. RE-AIM considers the interrelated constructs of reach, effectiveness, adoption, implementation, and maintenance, each of which can inform efforts to disseminate evidence-based practices with potential to improve cancer care delivery [17]. The present analysis aggregated quantitative and qualitative data (Supplemental Table A) across the four pilot studies, including additional data collected but not reported in the initial studies, to identify meta-inferences for the scale and spread of PCPRs. Data sources included patient and healthcare professional-reported semi-structured surveys gathered throughout pilot studies, data generated from PCPR testing and quality assurance activities, and fieldnotes from implementation team meetings across the pilots. Quantitative data were analyzed using descriptive statistics. Qualitative data from open-ended survey responses were analyzed using directed content analysis. Fieldnotes from implementation team meetings were analyzed using a deductive thematic analysis guided by RE-AIM, with iterative review by full study team to confirm themes. The team reviewed quantitative and qualitative data within each pilot, and then across all four pilots, to identify cross-pilot learnings as well as learnings unique to each cancer site. Table 2 provides an operational definition of the RE-AIM constructs for PCPRs, as well as a summary of RE-AIM findings and recommendations.
Table 2
Summary of implementation learnings and recommendations for dissemination & implementation of patient-centered pathology tools
RE-AIM Construct
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Definition for PCPR context
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Experiences
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Recommendations
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Reach
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Feasibility of PCPR use across cancer organ sites, pathology types, and care settings
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• Demonstrated feasibility in 4 cancer sites and multiple pathology types
• Lower feasibility for excisional pathology (e.g., polypectomy) with multiple specimens, which limits reach
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• Focus on expansion for preliminary biopsy results, given this offers a greater opportunity to reduce patient anxiety, reduce waste with unnecessary follow-up, and promote appropriate surveillance
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Effectiveness
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Impact of PCPR use on patient outcomes (e.g., knowledge) and patient and healthcare professional satisfaction with cancer decision-making
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• Improved knowledge (in some clinical domains but not all)
• Demonstrated patient acceptability and positive attitudes around enhancing activities of SDM
• Effectiveness potentially attenuates for subsequent pathology (e.g., surgical pathology following biopsy pathology)
• Healthcare professional-reported limited effectiveness during clinical visits
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• Continue to improve usability of PCPRs to support patient comprehension
• Identify pathways to integrate PCPRs into the decision-making process
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Adoption
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Uptake of PCPR use among eligible patients and healthcare professionals (e.g., oncology, surgical, pathology)
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• Few patients brought PCPRs to appointments
• Limited pathologist buy-in for PCPR adoption
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• More implementation-focused research, in particular stakeholder engagement, to address barriers to adoption
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Implementation
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Barriers and facilitators to the design and use of PCPRs in routine practice
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• Barriers related to clinical complexity (e.g., multiple specimens and integrating multiple diagnoses)
• Barriers related to logistics (e.g., timing of pathology resulting and need for multidisciplinary review)
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• Need for more sophisticated tools, such as natural language processing, that can more rapidly adapt to and accommodate clinical complexity
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Maintenance
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Barriers and facilitators to sustaining PCPRs in routine practice over the long term
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• Barriers related to IT prioritization and changing EHR technology
• Continuously changing and sometimes ambiguous clinical guidelines necessitate ongoing resource needs and stakeholder engagement
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• Need to align PCPR value with policy requirements such as Information Blocking
• Need to advocate for associated organization-level incentives and resources to advance patient-centered tools in cancer-related clinical care
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First, we present two case studies of PCPR implementation experiences. These two case studies – breast cancer and colorectal polyp - were chosen because they represent diverse workflows for pathology reporting in practice. A patient with breast cancer, for example, can receive pathology at several timepoints (e.g., core needle biopsy, post-surgical), and may incorporate multiple complex clinical concepts into their decision-making about cancer treatment. In contrast, a patient receiving a routine colonoscopy will use the results of their pathology to determine the frequency of their next screening colonoscopy and may or may not discuss these results with a healthcare professional directly. Following, we summarize how cross-pilot learnings can inform future dissemination for PCPRs and other patient-centered tools for cancer care.
CASE STUDY 1 Breast Cancer Pathology
Breast cancer PCPR templates were developed for core needle biopsy and surgical pathology reports. PCPR templates required eight rounds of quality assurance testing. For each round, a representative pathologist and surgical oncologist compared PCPR language with standard pathology report information and provided blind ratings of clinical accuracy for each cancer domain (e.g., stage, grade). Ratings were compared and arbitrated by the multidisciplinary team until consensus was reached on needed PCPR adaptations. PCPR templates for pathology of core needle biopsies reached consensus on clinical accuracy more quickly. In contrast, surgical PCPRs were more time intensive to refine as they included more complex clinical features (e.g., bilaterality, rare histology). Midway through PCPR development and testing, American Joint Committee on Cancer (AJCC) guidelines for breast cancer staging changed, necessitating a revision of PCPR language to reflect updated guidance.
PCPRs templates were built into PowerPath (Sunquest Information Systems, Tucson, AZ), a pathology laboratory information software (LIS) used by our healthcare system at the time of the pilot. PCPR templates followed the existing clinical templates for pathology reporting, so that at the conclusion of completing the standard pathology report, pathologists were given the option to generate an accompanying PCPR with a single click. Prior to pilot launch, the study was presented to all breast cancer pathologists onsite; however, not all pathologists elected to participate in the trial, citing beliefs that pathology reports are only intended for healthcare professionals, not patients. The exclusion of some pathologists from the pilot trial limited our reach of potential patients, particularly in recruitment for core needle biopsy patients, which has a rapid turnaround for pathology results (often 1–3 days).
During the pilot, 66 patients with a new breast cancer diagnosis (defined for this study to include invasive carcinomas or ductal carcinoma in situ) were enrolled, randomized to receive standard pathology reports with or without a PCPR, and completed study activities. Over the course of the study, PCPRs for 3 patients with surgical pathology (representing 8% of the PCPRs needed) could not be generated due to clinical complexity, including bilateral cancers and/or challenges with how some clinical features (e.g., hormone receptor status) were reported in non-standard ways that could not be integrated into PCPR algorithms. Enrolled patients received their pathology reports prior to scheduled visits with their surgical oncology healthcare professional. In healthcare professional-reported surveys (n = 56), healthcare professionals indicated that almost 90% of patients did not utilize a copy of their pathology reports (either on paper or digital) during their appointment. However, healthcare professionals reported that a higher proportion of patients in the PCPR arm referred specifically to their pathology results compared with patients who only received the standard pathology report (60% vs. 47%). Healthcare professionals also reported that they used the PCPR during the visit to help clarify terminology and concepts approximately 20% of the time. Within the survey, healthcare professionals offered comments that “the PCPR seemed to make the patient more prepared to discuss the path report” and that patients who received a PCPR “came in more educated with more directed questions [regarding] next steps of therapy as determined by the path report.” One healthcare professional described an example, saying:
The patient and her husband found [the PCPR] extraordinarily helpful. They expressed that the conventional pathology report contained a lot of medical jargon that they didn’t understand, but that the PCPR clarified
Among patients in the study, overall knowledge was higher in the PCPR arm compared with the control arm (66% vs. 50%); however, knowledge gains decreased over time and differences did not reach statistical significance. At the 30-day survey timepoint, 95% of patients in the PCPR arm agreed or strongly agreed that the PCPR was easy to understand, 90% reported that the PCPR helped them better understand their results, and 79% believed that it helped them better communicate with their healthcare professional. Open-ended responses (n = 41) on patient surveys indicated that patients felt the PCPRs “expanded understanding” of their pathology. One patient said “I liked that the report explained what different terminology meant and explained what various scores meant. Very helpful.” Another said, “I really like the patient centered pathology report and will bring it with me when meeting with my oncologist.”
In contrast, patients in the control group who only received standard pathology reports cited the need to have “a decoder for the different technical terms” and “more clear explanation on some technical terms.” As one patient who only received the standard pathology report described:
The version I received in [the patient portal] was all crammed together with odd line breaks, making it hard to read. A key to findings would be helpful, e.g. listing ‘Not performed,’ ‘Not identified,’ etc. along with an key as to whether they mean the same thing, and the implications of those items as they relate to terms like ‘positive’ or ‘negative.’
Another patient who only received the standard pathology report echoed this frustration, saying:
“There should be a glossary written in plain language. For example, the Nottingham score? I googled everything AND consulted with a physician friend of mine. […] A glossary is needed along with context. If something is grade 1, how many grades are there? […] It’s easier for me to see and digest the info THEN talk it over with my doctor.”
CASE STUDY 2 Colorectal Polyp Pathology
PCPRs for colorectal polyps were developed for noncancerous, precancerous, and cancerous polyp pathology, which reflected the breadth of findings from screening colonoscopies. The team met preliminary barriers, as polyp pathology often involves pathology results for multiple individual specimens, making it difficult to generate collective findings from multiple specimens in an automated way. Midway through PCPR development, our health system transitioned to a new her system, and the team was unable to prioritize health information technology (HIT) resources to build PCPRs within the new laboratory information system. Therefore, the team utilized a template outside of the EHR to generate PCPRs in a semi-automated fashion during the pilot study.
During the pilot, 44 patients were enrolled, randomized to receive pathology reports with or without a PCPR, and completed study activities. Patients received their pathology 1–2 weeks following their colonoscopy and typically did not have a follow-up visit with their healthcare professional. Overall knowledge of polyp pathology was slightly lower for the PCPR group at baseline (70% vs. 76%). However, knowledge was much higher (66% vs. 41%) for the PCPR group at the 30-day retention timepoint. The two domains patients with PCPRs had the highest knowledge for were understanding the types of polyps they had and the timing of their next screening colonoscopy.
At the 30-day survey timepoint, 85% of patients in the PCPR arm agreed or strongly agreed that the PCPR was easy to understand, and 70% reported that the PCPR helped them better understand their results. Open-ended responses (n = 28) from patients emphasized that the PCPR “had nice, simple, and relevant language with outcomes clearly spelled out […] and I didn't feel like I needed to do research to understand what it meant.” As one patient described, “communication to patients should be optimized in a separate report; so I would support the effort to have a separate report for patients.” Again, patients in the control arm who only received the standard pathology report highlighted that pathology reporting “need[s] to be written for a non-medical person.” As one patient said, “it is frustrating that I have to do so much internet research to find out what the diagnosis means.”