Validating a Framework for Coding Patient-Reported Health Information to the Medical Dictionary for Regulatory Activities Terminology: An Evaluative Study.

BACKGROUND: The availability of and interest in patient-generated health data (PGHD) have grown steadily. Patients describe medical experiences differently compared with how clinicians or researchers would describe their observations of those same experiences. Patients may find nonserious, known adverse drug events (ADEs) to be an ongoing concern, which impacts the tolerability and adherence. Clinicians must be vigilant for medically serious, potentially fatal ADEs. Having both perspectives provides patients and clinicians with a complete picture of what to expect from drug therapies. Multiple initiatives seek to incorporate patients' perspectives into drug development, including PGHD exploration for pharmacovigilance. The Food and Drug Administration (FDA) Adverse Event Reporting System contains case reports of postmarketing ADEs. To facilitate the analysis of these case reports, case details are coded using the Medical Dictionary for Regulatory Activities (MedDRA). PatientsLikeMe is a Web-based network where patients report, track, share, and discuss their health information. PatientsLikeMe captures PGHD through free-text and structured data fields. PatientsLikeMe structured data are coded to multiple medical terminologies, including MedDRA. The standardization of PatientsLikeMe PGHD enables electronic accessibility and enhances patient engagement. OBJECTIVE: The aim of this study is to retrospectively review PGHD for symptoms and ADEs entered by patients on PatientsLikeMe and coded by PatientsLikeMe to MedDRA terminology for concordance with regulatory-focused coding practices. METHODS: An FDA MedDRA coding expert retrospectively reviewed a data file containing verbatim patient-reported symptoms and ADEs and PatientsLikeMe-assigned MedDRA terms to determine the medical accuracy and appropriateness of the selected MedDRA terms, applying the International Council for Harmonisation MedDRA Term Selection: Points to Consider (MTS:PTC) guides. RESULTS: The FDA MedDRA coding expert reviewed 3234 PatientsLikeMe-assigned MedDRA codes and patient-reported verbatim text. The FDA and PatientsLikeMe were concordant at 97.09% (3140/3234) of the PatientsLikeMe-assigned MedDRA codes. The 2.91% (94/3234) discordant subset was analyzed to identify reasons for differences. Coding differences were attributed to several reasons but mostly driven by PatientsLikeMe's approach of assigning a more general MedDRA term to enable patient-to-patient engagement, while the FDA assigned a more specific medically relevant term. CONCLUSIONS: PatientsLikeMe MedDRA coding of PGHD was generally comparable to how the FDA would code similar data, applying the MTS:PTC principles. Discordant coding resulted from several reasons but mostly reflected a difference in purpose. The MTS:PTC coding principles aim to capture the most specific reported information about an ADE, whereas PatientsLikeMe may code patient-reported symptoms and ADEs to more general MedDRA terms to support patient engagement among a larger group of patients. This study demonstrates that most verbatim reports of symptoms and ADEs collected by a PGHD source, such as the PatientsLikeMe platform, could be reliably coded to MedDRA terminology by applying the MTS:PTC guide. Regarding all secondary use of novel data, understanding coding and standardization principles applied to these data types are important.

Building and testing a patient-centric electronic bedside communication center.

In this article, the authors describe the development and pilot testing of an electronic bedside communication center (eBCC) prototype to improve access to health information for hospitalized adults and their family caregivers. Focus groups were used to identify improvements for the initial eBCC prototype developed by the research team. Face-to-face bedside interviews and questions were presented while patients used the eBCC for usability testing to drive further development. Qualitative methods within an iterative, participatory approach supported the development of an eBCC prototype that was considered both easy to use and helpful for accessing tailored patient information during an inpatient hospitalization to receive acute care.

Bedside information technology to support patient-centered care.

PURPOSE: Patients and health care providers often lack real time access to information at the bedside required to provide safe patient-centered care. Both groups identified pertinent information needed at the patient's bedside. The purpose of our research was to identify the essential data elements that will be used to define requirements for a useful bedside communication tool in the acute care hospital setting. METHODS: Descriptive research methods were used to identify bedside information requirements through group and individual interviews. Data from patients and health care providers were analyzed to identify common themes, compiled into a survey, and validated by both groups. RESULTS: Thirty-seven information requirements were identified and classified under five themes: (1) plan of care, (2) patient education, (3) communication of safety alerts, (4) diet, and (5) medications. A survey completed by 30 patients and 30 health care providers confirmed 36 specific bedside information requirements (mean ≥ 5 on an 11-point scale). Patients and health providers each identified 24 specific information requirements that were similar in importance. When compared with nurses, significant differences were noted in the degree to which patients identified knowing the "daily routine schedule," e.g. when their doctor typically sees patients as a key requirement for the electronic bedside communication tool, t=3.52, p=.001. CONCLUSION: Patients and health care providers identified information requirements at the bedside to promote self-care management of healthcare needs and an understanding of the hospital environment. Accurate, easily accessed information at the bedside is needed for providing safe patient-centered care.

An electronic patient risk communication board.

Communication failures have been identified as the root cause of the majority of medical malpractice claims and patient safety violations. We believe it is essential to share key patient risk information with healthcare team members at the patient's bedside. In this study, we developed an electronic Patient Risk Communication Board (ePRCB) to assist in bridging the communication gap between all health care team members. The goal of the ePRCB is to effectively communicate the patient's key risk factors, such as a fall risk or risk of aspiration, to the healthcare team and to reduce adverse events caused by communication failures. The ePRCB will transmit patient risk information and tailored interventions with easy-to-understand icons on an LCD screen at the point of care. A set of patient risk reminder icons was developed and validated by focus groups. We used the results of the evaluation to refine the icons for the ePRCB.

Electronic health records and personal health records.

OBJECTIVES: To provide an overview of electronic personal health information technology. DATA SOURCES: Peer reviewed research studies, review articles, and web resources. CONCLUSION: As technology develops and electronic health records become more common, patients and clinicians are working toward a safer, more personal form of health care delivery. IMPLICATIONS FOR NURSING PRACTICE: Improving access and input to personal health information is still in its infancy, but with government funding, development of patient health records will continue to grow. Patients are the consumers of health care and are witness to the paradigm shift of access to health information and changes in information communication technology (ICT). For the oncology nurse, the transformation of health care and ICT will require nurses to educate patients and family members on available online resources for self management and health promotion.

Development of automated quality reporting: aligning local efforts with national standards.

As providers and systems move towards meaningful use of electronic health records, the once distant vision of data reuse for automated quality reporting may soon become a reality. To facilitate consistent and reliable reporting and benchmarking beyond the local level, standardization of both electronic health record content and quality measures is needed at the concept level. This degree of standardization requires local and national advancement and coordination. The purpose of this paper is to review national efforts that can be leveraged to guide local information modeling and terminology work to support automated quality reporting. Moreover, efforts at Partners HealthCare to map electronic health record content to inpatient quality metrics, terminology standards and to align local efforts with national initiatives are reported. We found that forty-one percent (41%) of the elements needed to populate the inpatient quality measures are represented within the draft documentation content and an additional 29.5% are represented within other Partners HealthCare (PHS) electronic applications. Recommendations are made to support data reuse based on established national standards and identified gaps. Our work indicates that value exists in individual healthcare systems engaging in local standardization work by adopting established methods and standards where they exist. A process is needed, however, to ensure that local work is shared and available to inform national standards.