What's going well: a qualitative analysis of positive patient and family feedback in the context of the diagnostic process.

OBJECTIVES: Accurate and timely diagnosis relies on close collaboration between patients/families and clinicians. Just as patients have unique insights into diagnostic breakdowns, positive patient feedback may also generate broader perspectives on what constitutes a "good" diagnostic process (DxP). METHODS: We evaluated patient/family feedback on "what's going well" as part of an online pre-visit survey designed to engage patients/families in the DxP. Patients/families living with chronic conditions with visits in three urban pediatric subspecialty clinics (site 1) and one rural adult primary care clinic (site 2) were invited to complete the survey between December 2020 and March 2022. We adapted the Healthcare Complaints Analysis Tool (HCAT) to conduct a qualitative analysis on a subset of patient/family responses with ≥20 words. RESULTS: In total, 7,075 surveys were completed before 18,129 visits (39 %) at site 1, and 460 surveys were completed prior to 706 (65 %) visits at site 2. Of all participants, 1,578 volunteered positive feedback, ranging from 1-79 words. Qualitative analysis of 272 comments with ≥20 words described: Relationships (60 %), Clinical Care (36 %), and Environment (4 %). Compared to primary care, subspecialty comments showed the same overall rankings. Within Relationships, patients/families most commonly noted: thorough and competent attention (46 %), clear communication and listening (41 %) and emotional support and human connection (39 %). Within Clinical Care, patients highlighted: timeliness (31 %), effective clinical management (30 %), and coordination of care (25 %). CONCLUSIONS: Patients/families valued relationships with clinicians above all else in the DxP, emphasizing the importance of supporting clinicians to nurture effective relationships and relationship-centered care in the DxP.

Co-Designing an Initiative to Increase Shared Access to Older Adults' Patient Portals: Stakeholder Engagement.

BACKGROUND: The patient portal is a widely available secure digital platform offered by care delivery organizations that enables patients to communicate electronically with clinicians and manage their care. Many organizations allow patients to authorize family members or friends-"care partners"-to share access to patient portal accounts, thus enabling care partners to receive their own identity credentials. Shared access facilitates trilateral information exchange among patients, clinicians, and care partners; however, uptake and awareness of this functionality are limited. OBJECTIVE: We partnered with 3 health care organizations to co-design an initiative that aimed to increase shared access registration and use and that can be implemented using existing patient portals. METHODS: In 2020, we undertook a rigorous selection process to identify 3 geographically diverse health care organizations that had engaged medical informatics teams and clinical champions within service delivery lines caring for older adults. We prioritized selecting organizations that serve racially and socioeconomically diverse populations and possess sophisticated reporting capabilities, a stable patient portal platform, a sufficient volume of older adult patients, and active patient and family advisory councils. Along with patients and care partners, clinicians, staff, and other stakeholders, the study team co-designed an initiative to increase the uptake of shared access guided by either an iterative, human-centered design process or rapid assessment procedures of stakeholders' inputs. RESULTS: Between February 2020 and April 2022, 73 stakeholder engagements were conducted with patients and care partners, clinicians and clinic staff, medical informatics teams, marketing and communications staff, and administrators, as well as with funders and thought leaders. We collected insights regarding (1) barriers to awareness, registration, and use of shared access; (2) features of consumer-facing educational materials to address identified barriers; (3) features of clinician- and staff-facing materials to address identified barriers; and (4) approaches to fit the initiative into current workflows. Using these inputs iteratively via a human-centered design process, we produced brochures and posters, co-designed organization-specific web pages detailing shared access registration processes, and developed clinician and staff talking points about shared access and staff tip sheets that outline shared access registration steps. Educational materials emphasized the slogan "People remember less than half of what their doctors say," which was selected from 9 candidate alternatives as resonating best with the full range of the initiative's stakeholders. The materials were accompanied by implementation toolkits specifying and reinforcing workflows involving both in-person and telehealth visits. CONCLUSIONS: Meaningful and authentic stakeholder engagement allowed our deliberate, iterative, and human-centered co-design aimed at increasing the use of shared access. Our initiative has been launched as a part of a 12-month demonstration that will include quantitative and qualitative analysis of registration and use of shared access. Educational materials are publicly available at Coalition for Care Partners.

Perspectives of Patients About Immediate Access to Test Results Through an Online Patient Portal.

Importance: The 21st Century Cures Act Final Rule mandates the immediate electronic availability of test results to patients, likely empowering them to better manage their health. Concerns remain about unintended effects of releasing abnormal test results to patients. Objective: To assess patient and caregiver attitudes and preferences related to receiving immediately released test results through an online patient portal. Design, Setting, and Participants: This large, multisite survey study was conducted at 4 geographically distributed academic medical centers in the US using an instrument adapted from validated surveys. The survey was delivered in May 2022 to adult patients and care partners who had accessed test results via an online patient portal account between April 5, 2021, and April 4, 2022. Exposures: Access to test results via a patient portal between April 5, 2021, and April 4, 2022. Main Outcomes and Measures: Responses to questions related to demographics, test type and result, reaction to result, notification experience and future preferences, and effect on health and well-being were aggregated. To evaluate characteristics associated with patient worry, logistic regression and pooled random-effects models were used to assess level of worry as a function of whether test results were perceived by patients as normal or not normal and whether patients were precounseled. Results: Of 43 380 surveys delivered, there were 8139 respondents (18.8%). Most respondents were female (5129 [63.0%]) and spoke English as their primary language (7690 [94.5%]). The median age was 64 years (IQR, 50-72 years). Most respondents (7520 of 7859 [95.7%]), including 2337 of 2453 individuals (95.3%) who received nonnormal results, preferred to immediately receive test results through the portal. Few respondents (411 of 5473 [7.5%]) reported that reviewing results before they were contacted by a health care practitioner increased worry, though increased worry was more common among respondents who received abnormal results (403 of 2442 [16.5%]) than those whose results were normal (294 of 5918 [5.0%]). The result of the pooled model for worry as a function of test result normality was statistically significant (odds ratio [OR], 2.71; 99% CI, 1.96-3.74), suggesting an association between worry and nonnormal results. The result of the pooled model evaluating the association between worry and precounseling was not significant (OR, 0.70; 99% CI, 0.31-1.59). Conclusions and Relevance: In this multisite survey study of patient attitudes and preferences toward receiving immediately released test results via a patient portal, most respondents preferred to receive test results via the patient portal despite viewing results prior to discussion with a health care professional. This preference persisted among patients with nonnormal results.

Challenges to Using Big Data in Cancer.

Big data in healthcare can enable unprecedented understanding of diseases and their treatment, particularly in oncology. These data may include electronic health records, medical imaging, genomic sequencing, payor records, and data from pharmaceutical research, wearables, and medical devices. The ability to combine datasets and use data across many analyses is critical to the successful use of big data and is a concern for those who generate and use the data. Interoperability and data quality continue to be major challenges when working with different healthcare datasets. Mapping terminology across datasets, missing and incorrect data, and varying data structures make combining data an onerous and largely manual undertaking. Data privacy is another concern addressed by the Health Insurance Portability and Accountability Act, the Common Rule, and the General Data Protection Regulation. The use of big data is now included in the planning and activities of the FDA and the European Medicines Agency. The willingness of organizations to share data in a precompetitive fashion, agreements on data quality standards, and institution of universal and practical tenets on data privacy will be crucial to fully realizing the potential for big data in medicine.

Case Studies for Overcoming Challenges in Using Big Data in Cancer.

The analysis of big healthcare data has enormous potential as a tool for advancing oncology drug development and patient treatment, particularly in the context of precision medicine. However, there are challenges in organizing, sharing, integrating, and making these data readily accessible to the research community. This review presents five case studies illustrating various successful approaches to addressing such challenges. These efforts are CancerLinQ, the American Association for Cancer Research Project GENIE, Project Data Sphere, the National Cancer Institute Genomic Data Commons, and the Veterans Health Administration Clinical Data Initiative. Critical factors in the development of these systems include attention to the use of robust pipelines for data aggregation, common data models, data deidentification to enable multiple uses, integration of data collection into physician workflows, terminology standardization and attention to interoperability, extensive quality assurance and quality control activity, incorporation of multiple data types, and understanding how data resources can be best applied. By describing some of the emerging resources, we hope to inspire consideration of the secondary use of such data at the earliest possible step to ensure the proper sharing of data in order to generate insights that advance the understanding and the treatment of cancer.

From Individuals to Systems and Contributions to Creations: Novel Framework for Mapping the Efforts of Individuals by Convening The Center of Health and Health Care.

BACKGROUND: People with lived health care experiences (often referred to as "patients") are increasingly contributing to health care and are most effective when they are involved as partners who can contribute complementary knowledge alongside other stakeholders in health care. OBJECTIVE: Convening The Center aimed to bring together "people known as patients"-the center of health care-to address priorities as they defined them. METHODS: According to the original project design, an in-person gathering was to be conducted; however, as a result of the COVID-19 pandemic, the in-person gathering was transformed into a series of digital gatherings, including an in-depth interview phase, small-group gatherings, and a collective convening of 25 participants (22 women and 3 men from the United States, India, Costa Rica, Sweden, and Pakistan). Each participant was interviewed on Zoom (Zoom Video Communications Inc), and the interview data were thematically analyzed to design a subsequent small group and then full cohort Zoom sessions. Visual note-taking was used to reinforce a shared understanding of each individual- and group-level conversation. RESULTS: The interviews and gatherings for Convening The Center offered unique perspectives on patient activities in research, health innovation, and problem-solving. This project further developed a novel, two-spectrum framework for assessing different experiences that patients may have or seek to gain, based on what patients actually do, and different levels of patients' involvement, ranging from individual to community to systemic involvement. CONCLUSIONS: The descriptors of patients in academic literature typically focus on what health care providers think patients "are" rather than on what patients "do." The primary result of this project is a framework for mapping what patients "do" and "where" they do their work along two spectra: from creating their own projects to contributing to work initiated by others and from working at levels ranging from individual to community to systems. A better understanding of these spectra may enable researchers to more effectively engage and leverage patient expertise in health care research and innovation.

Filling a gap in safety metrics: development of a patient-centred framework to identify and categorise patient-reported breakdowns related to the diagnostic process in ambulatory care.

BACKGROUND: Patients and families are important contributors to the diagnostic team, but their perspectives are not reflected in current diagnostic measures. Patients/families can identify some breakdowns in the diagnostic process beyond the clinician's view. We aimed to develop a framework with patients/families to help organisations identify and categorise patient-reported diagnostic process-related breakdowns (PRDBs) to inform organisational learning. METHOD: A multi-stakeholder advisory group including patients, families, clinicians, and experts in diagnostic error, patient engagement and safety, and user-centred design, co-developed a framework for PRDBs in ambulatory care. We tested the framework using standard qualitative analysis methods with two physicians and one patient coder, analysing 2165 patient-reported ambulatory errors in two large surveys representing 25 425 US respondents. We tested intercoder reliability of breakdown categorisation using the Gwet's AC1 and Cohen's kappa statistic. We considered agreement coefficients 0.61-0.8=good agreement and 0.81-1.00=excellent agreement. RESULTS: The framework describes 7 patient-reported breakdown categories (with 40 subcategories), 19 patient-identified contributing factors and 11 potential patient-reported impacts. Patients identified breakdowns in each step of the diagnostic process, including missing or inaccurate main concerns and symptoms; missing/outdated test results; and communication breakdowns such as not feeling heard or misalignment between patient and provider about symptoms, events, or their significance. The frequency of PRDBs was 6.4% in one dataset and 6.9% in the other. Intercoder reliability showed good-to-excellent reliability in each dataset: AC1 0.89 (95% CI 0.89 to 0.90) to 0.96 (95% CI 0.95 to 0.97); kappa 0.64 (95% CI 0.62, to 0.66) to 0.85 (95% CI 0.83 to 0.88). CONCLUSIONS: The PRDB framework, developed in partnership with patients/families, can help organisations identify and reliably categorise PRDBs, including some that are invisible to clinicians; guide interventions to engage patients and families as diagnostic partners; and inform whole organisational learning.

Guidelines for optimal utilization of social media for brain tumor stakeholders.

OBJECTIVE: Effective use of social media (SM) by medical professionals is vital for better connections with patients and dissemination of evidence-based information. A study of SM utilization by different stakeholders in the brain tumor community may help determine guidelines for optimal use. METHODS: Facebook, Twitter, and YouTube were searched by using the term "Brain Tumor." Platform-specific metrics were determined, including audience size, as a measure of popularity, and mean annual increase in audience size, as a measure of performance on SM. Accounts were categorized on the basis of apparent ownership and content, with as many as two qualitative themes assigned to each account. Correlations of content themes and posting behavior with popularity and performance metrics were assessed by using the Pearson's test. RESULTS: Facebook (67 pages and 304,581 likes) was predominantly used by organizations (64% of pages). Top themes on Facebook, Twitter, and YouTube were charity and fundraising (67% of pages), education and research (72% of accounts), and experience sharing and support seeking (48% of videos, 60% of views, and 82% of user engagement), respectively. On Facebook, only the presence of other concurrent platforms influenced a page's performance (rho = 0.59) and popularity (rho = 0.61) (p < 0.05). On Twitter, the number of monthly tweets (rho = 0.66) and media utilization (rho = 0.78) were significantly correlated with increased popularity and performance (both p < 0.05). Personal YouTube videos (30% of videos and 61% of views) with the theme of experience sharing and support seeking had the highest level of engagement (60% of views, 70% of comments, and 87% of likes). CONCLUSIONS: Popularity and prevalence of qualitative themes differ among SM platforms. Thus, optimal audience engagement on each platform can be achieved with thematic considerations. Such considerations, along with optimal SM behavior such as media utilization and multiplatform presence, may help increase content popularity and thus increase community access to neurooncology content provided by medical professionals.

Open notes sounds great, but will a provider's documentation change? An exploratory study of the effect of open notes on oncology documentation.

OBJECTIVE: The effects of shared clinical notes on patients, care partners, and clinicians ("open notes") were first studied as a demonstration project in 2010. Since then, multiple studies have shown clinicians agree shared progress notes are beneficial to patients, and patients and care partners report benefits from reading notes. To determine if implementing open notes at a hematology/oncology practice changed providers' documentation style, we assessed the length and readability of clinicians' notes before and after open notes implementation at an academic medical center in Boston, MA, USA. MATERIALS AND METHODS: We analyzed 143 888 notes from 60 hematology/oncology clinicians before and after the open notes debut at Beth Israel Deaconess Medical Center, from January 1, 2012 to September 1, 2016. We measured the providers' (medical doctor/nurse practitioner) documentation styles by analyzing character length, the number of addenda, note entry mode (dictated vs typed), and note readability. Measurements used 5 different readability formulas and were assessed on notes written before and after the introduction of open notes on November 25, 2013. RESULTS: After the introduction of open notes, the mean length of progress notes increased from 6174 characters to 6648 characters (P < .001), and the mean character length of the "assessment and plan" (A&P) increased from 1435 characters to 1597 characters (P < .001). The Average Grade Level Readability of progress notes decreased from 11.50 to 11.33, and overall readability improved by 0.17 (P = .01). There were no statistically significant changes in the length or readability of "Initial Notes" or Letters, inter-doctor communication, nor in the modality of the recording of any kind of note. CONCLUSIONS: After the implementation of open notes, progress notes and A&P sections became both longer and easier to read. This suggests clinician documenters may be responding to the perceived pressures of a transparent medical records environment.

The benefits and harms of open notes in mental health: A Delphi survey of international experts.

IMPORTANCE: As of April 5, 2021, as part of the 21st Century Cures Act, new federal rules in the U.S. mandate that providers offer patients access to their online clinical records. OBJECTIVE: To solicit the view of an international panel of experts on the effects on mental health patients, including possible benefits and harms, of accessing their clinical notes. DESIGN: An online 3-round Delphi poll. SETTING: Online. PARTICIPANTS: International experts identified as clinicians, chief medical information officers, patient advocates, and informaticians with extensive experience and/or research knowledge about patient access to mental health notes. MAIN OUTCOMES, AND MEASURES: An expert-generated consensus on the benefits and risks of sharing mental health notes with patients. RESULTS: A total of 70 of 92 (76%) experts from 6 countries responded to Round 1. A qualitative review of responses yielded 88 distinct items: 42 potential benefits, and 48 potential harms. A total of 56 of 70 (80%) experts responded to Round 2, and 52 of 56 (93%) responded to Round 3. Consensus was reached on 65 of 88 (74%) of survey items. There was consensus that offering online access to mental health notes could enhance patients' understanding about their diagnosis, care plan, and rationale for treatments, and that access could enhance patient recall and sense of empowerment. Experts also agreed that blocking mental health notes could lead to greater harms including increased feelings of stigmatization. However, panelists predicted there could be an increase in patients demanding changes to their clinical notes, and that mental health clinicians would be less detailed/accurate in documentation. CONCLUSIONS AND RELEVANCE: This iterative process of survey responses and ratings yielded consensus that there would be multiple benefits and few harms to patients from accessing their mental health notes. Questions remain about the impact of open notes on professional autonomy, and further empirical work into this practice innovation is warranted.

Patient Perceptions of Receiving COVID-19 Test Results via an Online Patient Portal: An Open Results Survey.

BACKGROUND: In the United States, attention has been focused on "open notes" and "open results" since the Office of the National Coordinator for Health Information Technology implemented the 21st Century Cures Act Final Rule on information blocking. Open notes is an established best practice, but open results remains controversial, especially for diseases associated with stigma, morbidity, and mortality. Coronavirus disease 2019 (COVID-19) is associated with all three of these effects and represents an ideal disease for the study of open results for sensitive test results. OBJECTIVES: This study evaluates patient perspectives related to receiving COVID-19 test results via an online patient portal prior to discussion with a clinician. METHODS: We surveyed adults who underwent COVID-19 testing between March 1, 2020 and October 21, 2020 who agreed to be directly contacted about COVID-19-related research about their perspectives on receiving test results via a patient portal. We evaluated user roles (i.e., patient vs. care partner), demographic information, ease of use, impact of immediate release, notification of results, impact of viewing results on health management, and importance of sharing results with others. RESULTS: Users were mostly patients themselves. Users found the portal easy to use but expressed mixed preferences about the means of notification of result availability (e.g., email, text, or phone call). Users found immediate access to results useful for managing their health, employment, and family/childcare. Many users shared their results and encouraged others to get tested. Our cohort consisted mostly of non-Hispanic white, highly educated, English-speaking patients. CONCLUSION: Overall, patients found open results useful for COVID-19 testing and few expressed increased worries from receiving their results via the patient portal. The demographics of our cohort highlight the need for further research in patient portal equity in the age of open results.

How do older patients with chronic conditions view reading open visit notes?

BACKGROUND: We examine the experiences with and perceptions of the effect of reading clinical outpatient visit notes on patients with multiple chronic conditions at three healthcare organizations with significant experience sharing clinical notes with patients. METHODS: A cross-sectional survey was conducted via patient portals at three diverse healthcare organizations in the United States: Beth Israel Deaconess Medical Center (Boston, MA), UW Medical Center (Seattle, WA), and Geisinger Health System (Danville, PA). Participants were aged 65 and older patient portal users who read at least one clinical note over the 12 months before the survey. We examined the effect of note reading on patient engagement and managing medications. RESULTS: The majority of respondents had read two or more clinical notes in the 12 months before the survey. Patients with more than two chronic conditions were more likely than those with fewer or none to report that reading their notes helped them remember their care plan, take their medications as prescribed, and understand and feel more in control of their medications. Very few patients reported feeling worried or confused about their health or medications due to reading their notes. CONCLUSIONS: Older patients with chronic conditions are particularly vulnerable to misremembering and mismanaging their care and medication plans. Findings from this study suggest that these patients and their care partners could receive important benefits from accessing their notes. Healthcare organizations should work to maximize patient's engagement with their health information both through the patient portal and through other methods to ensure that patients and the healthcare systems reap the full benefit of the increased transparency of medical records.

COVID-19 and Open Notes: A New Method to Enhance Patient Safety and Trust.

From April 5, 2021, as part of the 21st Century Cures Act, all providers in the United States must offer patients access to the medical information housed in their electronic records. Via secure health portals, patients can log in to access lab and test results, lists of prescribed medications, referral appointments, and the narrative reports written by clinicians (so-called open notes). As US providers implement this practice innovation, we describe six promising ways in which patients' access to their notes might help address problems that either emerged with or were exacerbated by the COVID-19 pandemic.

Patients, clinicians and open notes: information blocking as a case of epistemic injustice.

In many countries, including patients are legally entitled to request copies of their clinical notes. However, this process remains time-consuming and burdensome, and it remains unclear how much of the medical record must be made available. Online access to notes offers a way to overcome these challenges and in around 10 countries worldwide, via secure web-based portals, many patients are now able to read at least some of the narrative reports written by clinicians ('open notes'). However, even in countries that have implemented the practice many clinicians have resisted the idea remaining doubtful of the value of opening notes, and anticipating patients will be confused or anxious by what they read. Against this scepticism, a growing body of qualitative and quantitative research reveals that patients derive multiple benefits from reading their notes. We address the contrasting perceptions of this practice innovation, and claim that the divergent views of patients and clinicians can be explained as a case of epistemic injustice. Using a range of evidence, we argue that patients are vulnerable to (oftentimes, non-intentional) epistemic injustice. Nonetheless, we conclude that the marginalisation of patients' access to their health information exemplifies a form of epistemic exclusion, one with practical and ethical consequences including for patient safety.

Preparing Patients and Clinicians for Open Notes in Mental Health: Qualitative Inquiry of International Experts.

BACKGROUND: In a growing number of countries worldwide, clinicians are sharing mental health notes, including psychiatry and psychotherapy notes, with patients. OBJECTIVE: The aim of this study is to solicit the views of experts on provider policies and patient and clinician training or guidance in relation to open notes in mental health care. METHODS: In August 2020, we conducted a web-based survey of international experts on the practice of sharing mental health notes. Experts were identified as informaticians, clinicians, chief medical information officers, patients, and patient advocates who have extensive research knowledge about or experience of providing access to or having access to mental health notes. This study undertook a qualitative descriptive analysis of experts' written responses and opinions (comments) to open-ended questions on training clinicians, patient guidance, and suggested policy regulations. RESULTS: A total of 70 of 92 (76%) experts from 6 countries responded. We identified four major themes related to opening mental health notes to patients: the need for clarity about provider policies on exemptions, providing patients with basic information about open notes, clinician training in writing mental health notes, and managing patient-clinician disagreement about mental health notes. CONCLUSIONS: This study provides timely information on policy and training recommendations derived from a wide range of international experts on how to prepare clinicians and patients for open notes in mental health. The results of this study point to the need for further refinement of exemption policies in relation to sharing mental health notes, guidance for patients, and curricular changes for students and clinicians as well as improvements aimed at enhancing patient and clinician-friendly portal design.