Patient Design: The Importance of Including Patients in Designing Health Care.

A paradigm shift is underway in the patient-clinician relationship, driven by irreversible changes in information access, yet the model under which clinicians are trained, care is conducted, and care delivery is designed has not changed significantly even though we call it "patient centered." Humanity endured centuries in which even doctors had little idea what the patient's problem really was. Science slowly solved that, and for a century, only doctors could know what was worth knowing. Today, the rise of the internet and digital health has led to the end of that era. We are already witnessing early signs of the era of participatory health: genuinely empowered people living their lives and managing their health according to their own priorities, in partnership and consultation with physicians as needed. This may feel like a threat to the physician's sacred role, but it is no more so than when physicians adopted informed consent and then shared decision-making. In the 2010s, many pharmaceutical, medical, and health care companies started to use patient centricity as a mantra. We argue that to drive this paradigm change fully into existence, we need to shift "patient centricity" from a relatively passive process, driven by industry needs, into a far more active, collaborative process driven by both parties' needs and preferences. To build this new world of practice and workflow, we simply must engage with patients as true partners. To achieve medicine's new potential, it must be optimized around the wants and priorities of the ultimate stakeholder-the party that has the most at stake in how it all plays out: the patient. Patient design is the approach that can make it happen.

Open Access as a Revolution: Knowledge Alters Power.

The slogan "Gimme My Damn Data" has become a hallmark of a patient movement whose goal is to gain access to data in their medical records. Its first conference appearance was ten years ago, in September 2009. In the decade since there have been enormous changes in both the technology and sociology of medicine as well as in their synthesis. As the patient movement has made strides, it has been met with opposition and obstacles. It has also become clear that the availability of Open Access information is just as empowering (or disabling) as access to electronic medical records and device data. Knowledge truly is power, and to withhold knowledge is to disempower patients. This essay lays out many examples of how this shows up as we strive for the best future of care.

Gimme My Damn Data (and Let Patients Help!): The #GimmeMyDamnData Manifesto.

Ten years ago, in 2009, "e-Patient Dave" deBronkart delivered an influential keynote speech at the Medicine 2.0 conference in Toronto, organized by the Journal of Medical Internet Research's (JMIR's) editor-in-chief Gunther Eysenbach, who themed the conference around the topics of participation, openness, collaboration, apomediation, and social networking to improve health care for the 21st century-with patient participation being a major component. Many see this as a defining event within the participatory medicine movement, perhaps the beginning of a social movement, similar to the women's rights movement, with the title of Dave's keynote "Gimme my damn data" becoming a rallying cry and hashtag for patients demanding more access to their electronic health records. On the occasion of the 20th anniversary of JMIR (and 10 years after the keynote), we are celebrating the impact of the keynote for the participatory medicine movement and #gimmemydamndata (also #GMDD) by publishing the transcript of these initial conversations as a manifesto of patients' rights to access their data and their right to save their lives.

Evaluation of the Patient Request Process for Radiology Imaging in U.S. Hospitals.

Background In the United States, patients have the right to access their protected health information. However, to the knowledge of the authors, no study has evaluated the patient request process and the barriers to patient access of their radiology images. Purpose To assess U.S. hospital compliance with federal regulations and patient ease of access to imaging studies. Materials and Methods In this cross-sectional study conducted from June 6 to December 3, 2018, 80 U.S. hospitals were contacted by telephone to determine their patient request process for imaging studies. A scripted interview was used to simulate the patient experience in requesting imaging studies. Hospitals were compared in terms of formats of release (compact disc [CD] via pick up, CD via mail, e-mail, online patient portal, or other online access), departments from which cine files can be requested, fees, and processing times. Results All 80 hospitals stated that they could provide imaging studies on CDs. Only six (8%) hospitals provided imaging studies via e-mail and three (4%) via an online patient portal. Requests for cine files were fulfilled by a department separate from diagnostic radiology in 47 of 80 (59%) hospitals. Patient charges ranged from $0 to $75 for a single CD, no charge to $6 via e-mail, and no charge via an online patient portal. Fifty-nine (74%) hospitals stated that they could release copies within 24 hours, 10 (13%) within 2-5 days, eight (10%) within 5-10 days, and three (4%) within 10-30 days from request date. Imaging studies from outside of the diagnostic radiology department may need to be requested through the departments that performed the study. Conclusion This study demonstrated that although fees and processing times are compliant with federal regulations, patient access to imaging studies is limited primarily to compact disc format. The request process is also complicated for patients because of dispersion of imaging studies across departments. © RSNA, 2019 Online supplemental material is available for this article.

Developing and Testing a Personalized, Evidence-Based, Shared Decision-Making Tool for Stent Selection in Percutaneous Coronary Intervention Using a Pre-Post Study Design.

Background Drug-eluting stents reduce the risk of restenosis in patients undergoing percutaneous coronary intervention, but their use necessitates prolonged dual antiplatelet therapy, which increases costs and bleeding risk, and which may delay elective surgeries. While >80% of patients in the United States receive drug-eluting stents, less than a third report that their physicians discussed options with them. Methods and Results An individualized shared decision-making (SDM) tool for stent selection was designed and implemented at 2 US hospitals. In the postimplementation phase, all patients received the SDM tool before their procedure, with or without decision coaching from a trained nurse. All patients were interviewed with respect to their knowledge of stents, their participation in SDM, and their stent preference. Between May 2014 and December 2016, 332 patients not receiving the SDM tool, 113 receiving the SDM tool with coaching, and 136 receiving the tool without coaching were interviewed. Patients receiving the SDM tool + coaching, as compared with usual care, demonstrated higher knowledge scores (mean difference +1.8; P<0.001), reported more frequent participation in SDM (odds ratio=2.96; P<0.001), and were more likely to state a stent preference (odds ratio=2.00; P<0.001). No significant differences were observed between the use of the SDM tool without coaching and usual care. For patients who voiced a stent preference, concordance between stent desired and stent received was 98% for patients who preferred a drug-eluting stent and 50% for patients who preferred a bare metal stent. The SDM tool (with or without coaching) had no impact on stent selection or concordance. Conclusions An SDM tool for stent selection was associated with improvements in patient knowledge and SDM only when accompanied by decision coaching. However, the SDM tool (with or without coaching) had no impact on stent selection or concordance between patients' stent preference and stent received, suggesting that physician-level barriers to SDM may exist. Clinical Trial Information URL: https://www.clinicaltrials.gov . Unique Identifier: NCT02046902.

The patient's voice in the emerging era of participatory medicine.

Professionalism in any field requires keeping pace with change, and nowhere is it more true than medicine. Knowledge flow has changed dramatically since today's accreditation standards were developed, and change continues more rapidly than ever. It's time for a fresh look at how best to achieve care in this altered environment, where valid knowledge may come from the patient as well as from clinician resources: a sociological change driven by technological change. The power structure of the clinical relationship is inevitably altered as constraints on patient knowledge are loosened by the internet, apps, and devices, undermining a paradigm of patients as uninformed recipients of care based on a one-way flow of wisdom from providers. Case after case is presented showing that patients today have generated undeniable value, violating the expectations and assumed best practices of the old model. To understand this sociological (yet scientific) change, this article reviews the role of paradigms in the history of sciences as described in Thomas Kuhn's landmark book The Structure of Scientific Revolutions and describes how these anomalous patient stories force the conclusion that the traditional paradigm of patients is no longer supportable and a new paradigm is needed. This in turn means our standards of professionalism and appropriate care must be updated, lest we fail to achieve best possible care in our increasingly overburdened system. Our new standard must be to teach clinicians to recognize, welcome, and work with empowered "e-patients" in the new model of participatory medicine.

Assessment of US Hospital Compliance With Regulations for Patients' Requests for Medical Records.

Importance: Although federal law has long promoted patients' access to their protected health information, this access remains limited. Previous studies have demonstrated some issues in requesting release of medical records, but, to date, there has been no comprehensive review of the challenges that exist in all aspects of the request process. Objective: To evaluate the current state of medical records request processes of US hospitals in terms of compliance with federal and state regulations and ease of patient access. Design, Setting, and Participants: A cross-sectional study of medical records request processes was conducted between August 1 and December 7, 2017, in 83 top-ranked US hospitals with independent medical records request processes and medical records departments reachable by telephone. Hospitals were ranked as the top 20 hospitals for each of the 16 adult specialties in the 2016-2017 US News & World Report Best Hospitals National Rankings. Exposures: Scripted interview with medical records departments in a single-blind, simulated patient experience. Main Outcomes and Measures: Requestable information (entire medical record, laboratory test results, medical history and results of physical examination, discharge summaries, consultation reports, physician orders, and other), formats of release (pick up in person, mail, fax, email, CD, and online patient portal), costs, and request processing times, identified on medical records release authorization forms and through telephone calls with medical records departments. Results: Among the 83 top-ranked US hospitals representing 29 states, there was discordance between information provided on authorization forms and that obtained from the simulated patient telephone calls in terms of requestable information, formats of release, and costs. On the forms, as few as 9 hospitals (11%) provided the option of selecting 1 of the categories of information and only 44 hospitals (53%) provided patients the option to acquire the entire medical record. On telephone calls, all 83 hospitals stated that they were able to release entire medical records to patients. There were discrepancies in information given in telephone calls vs on the forms between the formats hospitals stated that they could use to release information (69 [83%] vs 40 [48%] for pick up in person, 20 [24%] vs 14 [17%] for fax, 39 [47%] vs 27 [33%] for email, 55 [66%] vs 35 [42%] for CD, and 21 [25%] vs 33 [40%] for online patient portals), additionally demonstrating noncompliance with federal regulations in refusing to provide records in the format requested by the patient. There were 48 hospitals that had costs of release (as much as $541.50 for a 200-page record) above the federal recommendation of $6.50 for electronically maintained records. At least 6 of the hospitals (7%) were noncompliant with state requirements for processing times. Conclusions and Relevance: The study revealed that there are discrepancies in the information provided to patients regarding the medical records release processes and noncompliance with federal and state regulations and recommendations. Policies focused on improving patient access may require stricter enforcement to ensure more transparent and less burdensome medical records request processes for patients.

"I want to know everything": a qualitative study of perspectives from patients with chronic diseases on sharing health information during hospitalization.

BACKGROUND: Patient-centered care promotes the inclusion of the most prominent and important member of the health care team, the patient, as an active participant in information exchange and decision making. Patient self-management of a chronic disease requires the patient to bridge the gap between multiple care settings and providers. Hospitalizations often disrupt established self-management routines. Access to medical information during hospitalization reflects patients' rights to partner in their own care and has the potential to improve self-management as well as promote informed decision making during and after hospitalization. The objectives of this study were to elicit the perspectives of patients with chronic disease about desired medical information content and access during hospitalization. METHODS: This exploratory study incorporated a qualitative approach. The online survey included the research team created open and limited response survey, demographic and hospital characteristic questions, and the Patient Activation Measurement instrument (PAM®). Convenience and social media snowball sampling were used to recruit participants through patient support groups, email invitations, listservs, and blogs. The research team employed descriptive statistics and qualitative content analysis techniques. RESULTS: The study sample (n = 34) ranged in age from 20 to 76 (µ = 48; SD = 16.87), Caucasian (91%, n = 31), female (88%, n = 30) and very highly educated (64%, n = 22 were college graduates). The PAM® survey revealed a highly activated sample. Qualitative analysis of the open-ended question responses resulted in six themes: Caring for myself; I want to know everything; Include me during handoff and rounds; What I expect; You're not listening; and Tracking my health information. CONCLUSIONS: This study revealed that hospitalized patients want to be included in provider discussions, such as nursing bedside handoff and medical rounds. Only a few participants had smooth transitions from hospital to home. Participants expressed frustration with failures in communication among their providers during and after hospitalization and provider behaviors that interfered with patient provider communication processes. Patients also identified interest in maintaining their own health histories and information but most had to "cobble together" a myriad of methods to keep track of their evolving condition during hospitalization.

Beyond restenosis: Patients' preference for drug eluting or bare metal stents.

OBJECTIVES: To assess patients' perspective about factors associated with stent choice. BACKGROUND: Drug eluting stents (DES) markedly reduce the risk of repeat percutaneous coronary intervention (PCI), but necessitate a longer duration of dual anti-platelet therapy (DAPT) as compared with bare metal stents (BMS). Thus, understanding patients' perspective about factors associated with stent choice is paramount. METHODS: Patients undergoing angiography rated, on a 10-point scale, the importance (1 = not important, 10 = most important) of avoiding repeat revascularization and avoiding the following potential DAPT drawbacks: bleeding/bruising, more pills/day, medication costs and delaying elective surgery. The factor, or group of factors, that was rated highest by each patient was identified. RESULTS: Among 311 patients, repeat revascularization was the single most important consideration to 14.4% of patients, while 20.6% considered avoiding one of the DAPT drawbacks as most important. Most patients (65%) considered avoiding at least one DAPT drawback as important as avoiding repeat revascularization. In no subgroup of patients did more than a quarter of patients prefer avoiding repeat revascularization above all other concerns. Among patients undergoing PCI, more than three quarters received a DES, regardless of their stated preferences (DES use among those most valuing DES benefits, avoiding DAPT drawbacks, or both equally were 78.7%, 86.2%, and 85.6%, respectively, P = 0.56). CONCLUSION: Most patients reported that avoiding DAPT drawbacks was as important as avoiding repeat revascularization. Eliciting patient preferences regarding stent type can enhance shared decision-making and allow physicians to better tailor stent choice to patients' goals and values. TRIAL REGISTRATION: Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection (DECIDE-PCI). ClinicalTrials.gov Identifier: NCT02046902. URL: https://clinicaltrials.gov/ct2/show/NCT02046902 © 2017 Wiley Periodicals, Inc.

A new model: physician-patient collaboration in online communities and the clinical practice of oncology.

The practice of medicine is in the midst of a fundamental transformation based on the new availability of health information through the Internet and other sources accessible by the broad lay public, as well as on the easy sharing of experiences and content through social media. This is occurring at a time when the volume of new information required for optimal medical care is exceeding that which an individual physician can feasibly follow and master. The changes in cancer care are especially acute as we experience an ongoing reclassification of many disease entities to reflect divisions by molecular variables, often with new clinical options now optimized for very limited patient subsets. The increasing complexity of the field, combined with the high stakes of optimizing treatment decisions and the growing availability of a wide range of information in the public domain, make oncology an area in which patients and caregivers are most motivated to become active seekers of medical information and participants in their care decisions. The credibility of the available online information in such a situation has emerged as a critical issue, but physicians have historically been reluctant to create content or interact with the lay public in online patient communities. Here we will highlight several examples of collaborative engagement between health care professionals and motivated patients in an online environment that illustrate how a new bidirectional or even networked model that is a product of the Internet age can accelerate clinical research and improve delivery of cancer care.