21st Century Cures Research Articles

Patient portal access for caregivers of adult and geriatric patients: reframing the ethics of digital patient communication

Patient portals are poised to transform health communication by empowering patients with rapid access to their own health data. The 21st Century Cures Act is a US federal law that,...

Inviting patients to identify diagnostic concerns through structured evaluation of their online visit notes.

BackgroundThe 21st Century Cures Act mandates patients’ access to their electronic health record (EHR) notes. To our knowledge, no previous work has systematically invited patients to proactively report diagnostic concerns while documenting and tracking their diagnostic experiences through EHR-based clinician note review.ObjectiveTo test if patients can identify concerns about their diagnosis through structured evaluation of their online visit notes.MethodsIn a large integrated health system, patients aged 18–85 years actively using the patient portal and seen between October 2019 and February 2020 were invited to respond to an online questionnaire if an EHR algorithm detected any recent unexpected return visit following an initial primary care consultation (“at-risk” visit). We developed and tested an instrument (Safer Dx Patient Instrument) to help patients identify concerns related to several dimensions of the diagnostic process based on notes review and recall of recent “at-risk” visits. Additional questions assessed patients’ trust in their providers and their general feelings about the visit. The primary outcome was a self-reported diagnostic concern. Multivariate logistic regression tested whether the primary outcome was predicted by instrument variables.ResultsOf 293 566 visits, the algorithm identified 1282 eligible patients, of whom 486 responded. After applying exclusion criteria, 418 patients were included in the analysis. Fifty-one patients (12.2%) identified a diagnostic concern. Patients were more likely to report a concern if they disagreed with statements “the care plan the provider developed for me addressed all my medical concerns” [odds ratio (OR), 2.65; 95% confidence interval [CI], 1.45–4.87) and “I trust the provider that I saw during my visit” (OR, 2.10; 95% CI, 1.19–3.71) and agreed with the statement “I did not have a good feeling about my visit” (OR, 1.48; 95% CI, 1.09–2.01).ConclusionPatients can identify diagnostic concerns based on a proactive online structured evaluation of visit notes. This surveillance strategy could potentially improve transparency in the diagnostic process.

OpenNotes: transparency versus stigma in patient care

OpenNotes reflects an international trend towards transparency in patient care. By giving patients access to their clinical notes, OpenNotes aims to increase efficiency and shared decision making between patients and clinicians, and to improve patient adherence to care. After being piloted in three US hospital systems in 2010, OpenNotes became the federal mandate in the USA in April, 2021, through the 21st Century Cures Act, which required that patients be granted access to the entirety of their electronic medical record.

13. Confidentiality and Caring for Adolescent Patients in the Age of the 21st Century Cures Act

Adolescents’ confidence that their health information will be confidential is essential to an open, trusting patient-provider relationship. Some elements of adolescent confidentiality are protected by state and/or federal laws. However, the recent final ruling on implementation of the federal 21st Century Cures Act, which was designed to improve patients’ access to their electronic health records (EHR), lacks sufficient safeguards to protect adolescent confidentiality. As a result of the Cures Act, parents with proxy access to their child’s medical chart can now more easily obtain confidential information that the patient has the right to protect.

The geriatrics research instrument library: A resource for guiding instrument selection for researchers studying older adults with multiple chronic conditions.

BackgroundAfter the passage of the 21st Century Cures Act in the U.S., the Inclusion Across the Lifespan policy eliminates upper-age limits for research participation unless risk justified. Broader inclusion will necessitate the use of reliable instruments in research that characterize the health status and function of older adults with multiple chronic conditions. As there is a plethora of such instruments, the Geriatrics Research Instrument Library (GRIL) was developed as freely available online resource of data collection instruments commonly used in gerontological research. GRIL has been revised and updated by the Advancing Geriatrics Infrastructure and Network Growth (AGING) Initiative, a joint endeavor of the Health Care Systems Research Network (HCSRN) and the Older Americans Independence Centers (OAICs).MethodsExtensive PubMed literature searches and domain expert feedback were utilized to inventory and update GRIL through the addition of instruments and compiling of instrument metadata. GRIL is hosted on the National Institute on Aging OAIC Coordinating Center website with a platform utilizing Microsoft Structured Query Language (SQL) and an Adobe ColdFusion application server. Tracking statistics are collected using Google Analytics.ResultsPresently, GRIL includes 175 instruments across 18 domains, including instrument metadata such as instrument description, copyright information, completion time estimates, keywords, available translations, and a link and reference to the original manuscript describing the instrument. The GRIL website includes user-friendly features such as mobile platforming and resource links.ConclusionsGRIL provides a user-friendly public resource that facilitates clinical researchers in efficiently selecting appropriate instruments to measure clinical outcomes relevant to older adults across a full range of domains.

Establishing a Public Resource for Acceptable Surrogate Endpoints to Support FDA Marketing Applications.

Following a comprehensive and coordinated effort between CBER and CDER, FDA established a table of acceptable surrogate endpoints (SEs) to support drug marketing applications. The publicly accessible SE Table was first published in 2018 as a response to the 21st Century Cures Act legislation and is updated every 6 months to reflect current FDA thinking. The criteria for the table headings and content were chosen to foster succinctness and consistency, while reflecting the degree of scientific understanding for each listed SE. Prior to the publication of the SE table there was the misconception that FDA only approved drugs based on a limited number of SEs. Contrary to this viewpoint, the SE table demonstrates that FDA frequently uses SEs as they are used in over 100 disease/use and patient population combinations. This article describes the considerations and approach taken when establishing the SE table as well as a discussion of the benefits and limitations of the SE table when used by various stakeholders.

The 21st Century Cures Act and Multiuser Electronic Health Record Access: Potential Pitfalls of Information Release.

Although the Office of The National Coordinator for Health Information Technology’s (ONC) Information Blocking Provision in the Cures Act Final Rule is an important step forward in providing patients free and unfettered access to their electronic health information (EHI), in the contexts of multiuser electronic health record (EHR) access and proxy access, concerns on the potential for harm in adolescent care contexts exist. We describe how the provision could erode patients’ (both adolescent and older patients alike) trust and willingness to seek care. The rule’s preventing harm exception does not apply to situations where the patient is a minor and the health care provider wishes to restrict a parent’s or guardian’s access to the minor’s EHI to avoid violating the minor’s confidentiality and potentially harming patient-clinician trust. This may violate previously developed government principles in the design and implementation of EHRs for pediatric care. Creating legally acceptable workarounds by means such as duplicate “shadow charting” will be burdensome (and prohibitive) for health care providers. Under the privacy exception, patients have the opportunity to request information to not be shared; however, depending on institutional practices, providers and patients may have limited awareness of this exception. Notably, the privacy exception states that providers cannot “improperly encourage or induce a patient’s request to block information.” Fearing being found in violation of the information blocking provisions, providers may feel that they are unable to guide patients navigating the release of their EHI in the multiuser or proxy access setting. ONC should provide more detailed guidance on their website and targeted outreach to providers and their specialty organizations that care for adolescents and other individuals affected by the Cures Act, and researchers should carefully monitor charting habits in these multiuser or proxy access situations.

Abstract P5-19-02: Methodological approaches to the use of real-world data(RWD) for medical products to treat breast cancer: An FDA oncology center of excellence evaluation of RWD submissions

Abstract Background: Aligning with 21st Century Cures legislation, FDA is exploring various methodologies to advance appropriate uses of Real-World Data (RWD) to generate Real-World Evidence (RWE). Inclusion of RWD to support regulatory decision making has increased in oncology, and this review specifically focused on characterizing RWD submissions for the treatment of breast cancer (BC). Methods: A systematic search was conducted using internal FDA databases to identify RWD submissions from 2010 to 2020. Search terms included real world evidence, real world data, cancer registry, administrative claims, external control arm, and other terms relevant to RWD/RWE. Relevant regulatory submissions were reviewed, pre-defined common data elements were extracted, and the subset applicable to breast cancer was evaluated. Results: Of 142 regulatory submissions that included RWD, 6 specifically evaluated BC indications and 3 were for solid tumor indications with potential applicability to BC, corresponding to 4 new molecular entities. Regulatory objectives included support for labeling changes including efficacy (expanded indications), safety , and dose or administration modifications. The most commonly used design was a retrospective observational study with structured electronic health records (EHRs) or medical claims data, supplemented by unstructured data from medical records or chart review for missing data elements. Four of the 6 BC submissions were significantly limited by a high degree of data missingness and confounding, with some studies including key covariates that were missing in >50% of the structured data. RWD was used to provide contextual evidence for label expansion for populations not included or adequately represented in the registration trial. Of note, for the application expanding the label to include treatment of male BC, the regulatory decision was primarily based on clinical trial data. The primary rwEndpoints submitted were overall survival (rwOS), progression free survival (rwPFS), response rate (rwORR) and time to next treatment (TTNT). Safety outcomes were investigated in all but 1 of the studies, most commonly as a secondary RWD endpoint. Conclusion: In our review of regulatory submissions relevant to breast cancer therapies, RWD has largely been used to contextualize and complement prospective clinical trial data. Evaluating that selected RWD is fit for purpose to address the regulatory objective(s) and all analytical plans are prespecified allows for robust data characterization, and appropriate evaluation. Data relevance (availability of key variables) along with reliability assessment which includes evaluating data for completeness, consistency, and trends over time are necessary for the rigorous evaluation of RWE in drug development. Data missingness is a key issue in RWD, especially when structured data are not available and specific variables are unlikely to be captured in a reliable way in the unstructured data or further validation is not feasible. To optimize RWD as evidence for specific patient populations, attention to the proportion of patients excluded is necessary to avoid concerns regarding the generalizability of the data. Careful selection of rwEndpoints must be aligned with the study design and objective, include data such as prior, concomitant and subsequent anti-cancer treatments, and the ability for outcome validation to be methodologically appropriate. When contemplating a regulatory submission using RWD, early consultation with the appropriate FDA review division can provide additional feedback on the appropriate use of RWD or pragmatic designs. Citation Format: Melanie E Royce, Jennifer J. Lee, Christy L. Osgood, Laleh Amiri-Kordestani, Julia A. Beaver, Paul G. Kluetz, Donna R. Rivera. Methodological approaches to the use of real-world data(RWD) for medical products to treat breast cancer: An FDA oncology center of excellence evaluation of RWD submissions [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P5-19-02.

Emerging From Behind the Workstation.

Emerging From Behind the Workstation.

Immediate Radiology Report Access: A Burden to the Ordering Provider

PurposeMany practices have eliminated their delayed-release of radiology report programs in response to anticipated penalties under the information-blocking provision of the 21st Century Cures Act. Our purpose is to share the results and suggestions from a survey of our referring providers regarding the impact of the removal of the radiology report embargo on their practices. MethodsAn electronic survey invitation was sent to all referring providers at our institution. The survey consisted of 12 questions that solicited information regarding the calls and questions received by providers from patients who accessed their radiology reports in the online portal since the removal of the report embargo on October 20, 2020. Responses were collected and analyzed using descriptive statistics. ResultsOut of 4,671 survey recipients, there were 249 respondents (5.3%). 195 (78.3%) respondents reported being contacted by patients regarding their radiology reports and, of those, 165 (83.8%) reported an increase in patient call volume in the past 60 days since the radiology report embargo was removed. ConclusionsThe majority of ordering provider respondents reported an increase in the volume of patient calls regarding findings in their radiology reports following the removal of a radiology report embargo program. Practices contemplating the removal of their report embargoes in response to the information-blocking provision of the Cures Act should be aware of the potential impacts on patients and referring providers and consider strategies to mitigate patient anxiety and provider workflow disruption.

Best practices in the real-world data life cycle.

With increasing digitization of healthcare, real-world data (RWD) are available in greater quantity and scope than ever before. Since the 2016 United States 21st Century Cures Act, innovations in the RWD life cycle have taken tremendous strides forward, largely driven by demand for regulatory-grade real-world evidence from the biopharmaceutical sector. However, use cases for RWD continue to grow in number, moving beyond drug development, to population health and direct clinical applications pertinent to payors, providers, and health systems. Effective RWD utilization requires disparate data sources to be turned into high-quality datasets. To harness the potential of RWD for emerging use cases, providers and organizations must accelerate life cycle improvements that support this process. We build on examples obtained from the academic literature and author experience of data curation practices across a diverse range of sectors to describe a standardized RWD life cycle containing key steps in production of useful data for analysis and insights. We delineate best practices that will add value to current data pipelines. Seven themes are highlighted that ensure sustainability and scalability for RWD life cycles: data standards adherence, tailored quality assurance, data entry incentivization, deploying natural language processing, data platform solutions, RWD governance, and ensuring equity and representation in data.

Bringing Alzheimer Disease Testing and Results Disclosure Into the 21st Century Cures Act

Bringing Alzheimer Disease Testing and Results Disclosure Into the 21st Century Cures Act

Lessons Learned from OpenNotes Learning Mode and Subsequent Implementation across a Pediatric Health System.

The 21st Century Cures Act has accelerated adoption of OpenNotes, providing new opportunities for patient and family engagement in their care. However, these regulations present new challenges, particularly for pediatric health systems aiming to improve information sharing while minimizing risks associated with adolescent confidentiality and safety. Describe lessons learned preparing for OpenNotes across a pediatric health system during a 4-month trial period (referred to as "Learning Mode") in which clinical notes were not shared by default but decision support was present describing the upcoming change and physicians could request feedback on complex cases from a multidisciplinary team. During Learning Mode (December 3, 2020-March 9, 2021), implementation included (1) educational text at the top of commonly used note types indicating that notes would soon be shared and providing guidance, (2) a new confidential note type, and (3) a mechanism for physicians to elicit feedback from a multidisciplinary OpenNotes working group for complex cases with questions related to OpenNotes. The working group reviewed lessons learned from this period, as well as implementation of OpenNotes from March 10, 2021 to June 30, 2021. During Learning Mode, 779 confidential notes were written across the system. The working group provided feedback on 14 complex cases and also reviewed 7 randomly selected confidential notes. The proportion of physician notes shared with patients increased from 1.3% to 88.4% after default sharing of notes to the patient portal. Key lessons learned included (1) sensitive information was often present in autopopulated elements, differential diagnoses, and supervising physician note attestations; and (2) incorrect reasons were often selected by clinicians for withholding notes but this accuracy improved with new designs. While OpenNotes provides an unprecedented opportunity to engage pediatric patients and their families, targeted education and electronic health record designs are needed to mitigate potential harms of inappropriate disclosures.

Informed or anxious: patient preferences for release of test results of increasing sensitivity on electronic patient portals.

Worldwide, governments and healthcare systems are moving towards increased transparency to improve care quality, increase patient engagement, and decrease costs. For example, the American 21st Century Cures Act Final Rule requires providers to grant patients access to their electronic medical record. Unfortunately, limited research guides release of test results to online patient portals, especially concerning emotionally sensitive information. To address this gap, we surveyed the largest patient sample published to date. This cross-sectional survey project was conducted by the Market Research & Insights and Office of Patient Experience departments at a large academic medical center. Data were analyzed in SPSS using descriptive statistics and Z-tests. Of 8030 respondents, 74% and 57% accepted first learning their results online for cholesterol and strep throat tests, respectively. Most prefer in-person appointments for more serious tests detecting cancer (54%) and fetal miscarriage (53%). Excluding sexually transmitted disease (STD) testing, there are no clinically significant differences in preference between respondents previously diagnosed with the condition in question and respondents without such experience. When weighing the possibility of a 3-week wait to hear from their provider, most patients want automatic release of cholesterol (94%), strep throat (90%), genetic (68%), and STD (60%) test results, but the majority say it is unacceptable to receive Alzheimer’s (52%), fetal miscarriage (51%), and cancer (59%) test results this way. Electronic results release is acceptable for less serious tests, but not for more consequential tests. Providers should consider patient preferences when developing policies to increase healthcare transparency.Supplementary informationThe online version contains supplementary material available at 10.1007/s12553-021-00628-5.

Abstracts Presented at the 2nd Annual Advancing Healthcare Innovation Summit: Nov 11, 2022, Cincinnati, OH

Abstracts Presented at the 2nd Annual Advancing Healthcare Innovation Summit: Nov 11, 2022, Cincinnati, OH

Huu S. TIEU Request for FDA to Establish Regenerating Human Cells as Law on December 13, 2016 President Barack H. Obama Singed the 21st Century CURES Act into FDA Regulation and Law

Background and Aims: On November 24, 2009, Huu S. TIEU and Golden Sunrise Pharmaceutical, Inc. (Golden Sunrise) applied for the Technology and Innovation to be reviewed and evaluated by the U.S. Food and Drug Administration (FDA). In the review and evaluation, it was requested by Golden Sunrise designated the new indications for this application under Serious or Life-threatening conditions or diseases. Discussions followed with the FDA, Huu S. TIEU, and Golden Sunrise for FDA approval on new products and new indications on existing new Medical Technology and Innovation. It was agreed in Year-2015 that the FDA would take the request for new indications to the United States Congress to establish into FDA regulation and law. At that time the following was the FDA Guidance—“Emergency Use of a Test Article” is exempt from prior Institutional Review Board or Advisory Committee evaluation and approval, provided that such emergency use is reported to the Institutional Review Board within five working days after use. Expedited Institutional Review Board or Advisory Committee approval is not permitted in emergency use. There has been no funding to the authors for the writing or publication of this article. Methods: It was requested by Huu S. TIEU and Golden Sunrise in documents given to the FDA to have Serious or Life-threatening conditions or diseases indication be recognized by law. On August 08, 2015, the FDA responding to this request took the documentation produced by Golden Sunrise to the United States Congress on behalf of Golden Sunrise and Huu S. TIEU. This article encompasses the FDA regulatory method as well as the discussion and results of the establishment of the FDA and the 21st Century Cures Act. Results: On December 13, 2016, H.R.34—114th United States Congress (2015-2016) 21st Century CURES Act was signed into law by President Barack H. Obama which included the Serious or Life-threatening indication to be written into the CURES Act. In summary, the 21st Century Cures Act is a landmark piece of legislation that enjoyed broad bipartisan support in United States Congress. The main goals of the Act are impactful and should transform future cancer, neurologic, and precision medicine or drug research as well as aid individuals with mental health is intended to facilitate the prompt approval of new agents and devices, clinicians should be aware of the types of data behind an approval and take this into consideration when developing illnesses and opioid dependence. However, some of the wording within the CURES Act regarding the drug and device approval process may bring pause to health care providers including pharmacists. Although this wording and implementing care plans and counseling patients. The 21st Century Cures Act was incorporated into laws and regulations by the FDA under § 3072 of the Act grants the Commissioner of Food and Drugs the authority to appoint and set the annual rate of pay for outstanding and qualified candidates to scientific, technical, or professional positions that support the development, review, and regulation of medical products.

21st Century Cures Act: Inpatient Clinician Perceptions of Changes to Information Sharing at an Academic Medical Center

21st Century Cures Act: Inpatient Clinician Perceptions of Changes to Information Sharing at an Academic Medical Center

2020 FDA Drug Approvals: Does Investment in More and Larger Trials Result in Higher Price?

Since the passage of the 21st Century Cures Act in 2016, The US Food and Drug Administration (FDA) has applied less stringent guidelines for new drug evaluations [1], resulting in a decreasing number of RCTs before approval [2].

Patient and clinician perceptions of the immediate release of electronic health information

ObjectivesThe 21st Century Cures Act requires that institutions release all electronic health information (EHI) to patients immediately. We aimed to understand patient and clinician attitudes toward the immediate release of EHI to patients. MethodsPatients and clinicians representing distinct specialties at a single academic medical center completed a survey to assess attitudes toward the immediate release of results. Differences between patient and clinician responses were compared using chi-square and student's t-test for categorical and continuous variables, respectively. A two-sided significance level of 0.05 was used for all statistical tests. Results69 clinicians and 57 patients completed the survey. Both patients (89.7%) and clinicians (80.6%) agreed or strongly agreed-here after referred to as agreed, that providing patients with access to their health information is necessary in delivering high-quality care. However, 62.7% of clinicians agreed that results released immediately would be more confusing than helpful, whereas the minority of patients agreed with this statement (15.8%) (p < 0.05). Providers were also more likely to disagree that patients are comfortable independently interpreting blood work results (p < 0.05), radiology results (p < 0.05) and pathology reports (p < 0.05). With regard to timing, the majority of patients (75.1%) felt their provider should contact them within 24 h of the release of an abnormal result, whereas only 9.0% of clinicians agreed with this timeframe (p < 0.05). DiscussionsPatients and clinicians value information transparency. However, the immediate release of results is controversial, especially among clinicians. The discrepancy between patient and clinician perceptions underlines the importance of setting expectations about the communication of results. Additionally, our results emphasize the need to implement strategies to help improve patient comprehension, decrease patient distress and improve clinician workflows.

A retrospective review of unreimbursed medical care provided through electronic patient portals in dermatologic surgery

To the Editor: Patient portals, based on electronic medical records, allow patients to view medical records and securely message their practitioners. Direct messaging between patients and health care teams improves patient satisfaction.1 However, the number of patient-initiated messages has increased over time in dermatology and other fields.2,3 Although the increasing workload can be optimized, it cannot be eradicated.4 Patient portal messaging will likely increase further with the implementation of the 21st Century Cures Act, which allows patients immediate access to their health records.