Clinical informatics
Edward P. Ambinder, MD
Overview
Informatics is the integration of information technology into health care. For oncology, the need to understand informatics is critical because of the need to keep up with the rapidly changing basic, translational and clinical cancer research findings, therapeutic interventions using panomic data required for precision medicine, latest practice guidelines, shifting reimbursement practices, and the dominating and at times frustrating electronic health record (EHR) that is the repository of our health data and window into the health care system. All of this must take place in a value-enhanced practice environment that constantly measures our quality of care in a well-coordinated system for our engaged patients who are digitally connected to multiple practices, their hospital, their smartphones and medical devices, their personal health record and multiple EHRs. Oncologists will soon have a well-defined “Oncology Digital Health Information Technology System” that will redefine cancer research by capturing meaningful and actionable patient data in every cancer patient. They will continue to participate in the mobile computing revolution that is just beginning to have a transformative effect on all of medicine where computers will do our work, apps work with other apps and EHRs to educate us and our patients and use real electronically shareable and reusable medical data. Today, the majority of patients have their cancer care documented in EHRs. As rapid learning systems (RLSs) such as ASCO’s CancerLinQ capture all this data and use Big Data analytic tools for capturing and comparing similar cancer patients as to the best treatments and outcomes, we will have real precision medicine. The evolving “Internet of Things” where medical devices and health care platforms will give us the unprecedented ability to measure in real time the health and wellness of our cancer patients undergoing chemotherapy treatments on a 24-h basis will provide huge monetary savings for the health system, improved quality of care, and innovative medical research as cancer care develops into a RLS.
Introduction
Oncologists and their patients are facing disruptive changes in health care practice, research, governmental oversight, business practices, communication, and reimbursement—changes brought on by the individual growth and merging of the fields of information technology with medical technology, medical practice, biology, and physics. We now practice in large hospital systems or accountable care organizations rather than in small group practice silos; deal with changing reimbursement methods as we transition from fee-for-service to bundling payments and defined encounters of care; document our patient care using electronic media rather than paper; and see the doctor–patient relationship become more patient-centric. We are increasingly communicating electronically with all health care stakeholders, including our patients.
This dramatic increase in the quantity, quality, and ease of finding information—brought about by the use of computers and the effortlessness of connecting everyone and everything—all of which has been brought about by the Internet, has changed our lives forever. However, we remain frustrated with our electronic devices needed to communicate with our health care system because they still require typing or dictation for data entry, and the data entered are not easily understood by the computer or able to be shared, reused, or reported easily because of the absence of seamless data interoperability where data entered into one device could be understood, used, and reused effectively in another device.
Clayton Christensen presciently warned us about the disruptive effects of this transformation in 1997,1 and he warned us specifically about its effects on health care in 2008.2 Indeed, for the first time, this new, disruptive digital world of medicine is increasingly defined by information becoming electronically mobile, cheap, available to all, and consumer-oriented to such an extent that almost all recent information technology advances in hardware and software begin with the consumer rather than business. Oncologists and their patients must begin to understand this transformative event that will directly address our current frustrations.
An oncology digital health information technology system
Common data elements and value sets
Common data elements define the data to be collected in the medical record by specifically identifying the label of each data field and the appropriate value set to choose for data entry. When possible, the value set choice should reference a standard code system such as a clinical vocabulary used to describe the clinical encounter (e.g., SNOMED-CT), the laboratory data (e.g., LOINC), the terms describing basic and clinical research activities [e.g., cancer Biomedical Informatics Grid (caBIG)], and the elements and codes that define specific disease classifications used for billing and registry reporting purposes (e.g., ICD-9 and ICD-10 codes).
Data types
Computers capture electronic structured and unstructured data. Data can be structured using data elements and value sets that are machine readable, reusable, shareable, actionable, multiuser-able, and multipurposeful. Unstructured or narrative data are entered by typing or dictation and adds context making it is understood by humans but not by computers unless sophisticated natural language processing tools are used or the data can be tagged by metadata that renders them searchable. Searchable or machine-readable data would permit the EHR (electronic health record) to provide clinical decision support (CDS), user education, and secondary reporting purposes. In reality, both types of data are important in capturing the complete patient’s health record.
Software functionalities and documentation
Software functionalities refer to the capabilities that a software program should provide. For all EHRs, ePrescription software is necessary, whereas for medical oncology, EHRs chemotherapy administration is required. Table 1 lists EHR functional elements defined by ASCO’s EHR workgroup and Table 2 lists oncology-specific documentation required in an oncology EHR.
Table 1 EHR functional elements defined by ASCO’s Electronic Health Record Workgroup
| EHR functional element | How it is used in the practice |
| View patient information | Review patient’s symptoms or chief complaints, medication list, test results, and other clinical documentation |
| Gather data | Build electronic patient charts that are searchable. Build patient charts from customizable templates |
| Compile data | Pull together patient or practice population, histories, and graph it or map it for analysis. Report generation |
| Query patient or practice data to generate standard and/or custom reports | Assist in evaluating, diagnosing, and reviewing acute or chronic diseases and treatment regimens and provide appropriate clinical alerts and warnings based on established guidelines. Interoperability with other systems |
| Clinical decision support | Interact with internal practice management and other internal information systems (e.g., laboratory information system—LIS); interface with external hospital, lab, imaging, pharmacies, and payers |
| Search capabilities | Query the database for reports on clinical issues and costs |
| Patient management | Manage the individual patient’s acute and chronic diseases and conditions |
| Practice marketing | Provide information regarding types of services you perform most often. Provide analysis on your patients’ clinical conditions, referral base, and patient population |
| Standardization | Standardize disease management goals and treatment regimens for patient groups within your practice |
| Billing and coding | Provide internal checks and balances with ICD and CPT codes to details of the patient encounter; integrate E&M coding and HCPCS codes. Order entry, order labs, imaging, referrals, and other nonmedications |
| Chemotherapy ordering | Initiate chemotherapy orders, associated ancillary therapies, and dose modifications with proper authorization and confirmation |
| e-Prescribing | Authorize and manage prescription refills. Access formulary information. Route new prescriptions online to pharmacy |
| Communication | Communicate online with patients, colleagues, payers, hospitals, and pharmacies |
| Provide built-in compliance and regulatory guidance | Compliance |
| Clinical trials | Conduct research, registry, and clinical trial activities |
| Patient interaction | Incorporate information originating from the patient, including data from a personal health record (PHR) and medical and patient devices |
| Quality measurement | Use data to participate in quality measurement programs |
Table 2 Oncology-specific documentation required in an oncology EHR
| Provide menu-driven site/histology/pathology findings |
| Manage patient response to treatment on flow sheets |
| Document intent and goals of adjuvant/curative versus palliative therapy |
| Document patient performance status per standardized guidelines |
| Maintain list of co-morbid conditions and major toxicities expected to complicate chemotherapy |
| Plan and manage chemotherapy/biotherapy regimens |
| Manage and automate body surface area (BSA), starting doses, and dose adjustments |
| Manage chemotherapy delivery—IV and oral, number of cycles, duration |
| Document drug administration process |
| Track duration of treatment and number of planned cycles |
| Schedule and document radiation therapy and/or maintain results |
| Assess pain and supportive care needs |
| Manage patients on clinical trials |
| Clinical Oncology Treatment Plan and Summary and Survivorship Report |
Internet
The Internet serves as the communication and messaging component of the digital health care system. The development of the Internet can be separated into four stages. At its inception, the Internet was used for “searching” for information and “communicating” with text, files and pictures, and any media. Users were mostly academicians and business people. E-mail and bulletin boards were popular. Next, we were able to “do” things using web sites. Consumers discovered the Internet and commerce exploded. Then, we were able to “socialize” and “collaborate” using social media sites like Facebook. Apps exploded as mobile computing dominated the Internet. Now, we are entering the Internet of “Things,” where any medical device can inexpensively communicate over the Internet with other devices and computers.
Computer interoperability and data exchange
Computer interoperability and data exchange or the sharing of data requires that the data created in one EHR be sent to another EHR with full understanding and context so that it will be placed in the appropriate data field of the receiving program. ASCO and the National Cancer Institute’s caBIG and Community Cancer Center Program created the Clinical Oncology Requirements for the EHR (CORE) that delineated the core common data elements, functionalities, and interoperability standards for oncology that helped to define the original oncology EHR certification criteria used by the Certification Commission for Healthcare Information Technology (CCHIT).3 Seamless interoperability standards have foundational importance by defining and transmitting medical information in a way that will make our data entry, computerized workflows, and result reporting dramatically simplified and efficient.
Most of the data elements that we use in medicine have been defined, standardized, and harmonized into code sets and SNOMED-CT, a clinical vocabulary. Meaningful Use Stage 1 brought some interoperability to public health reporting. Meaningful use stage 2 brought additional interoperability to well-defined content, vocabulary, and transport standards for transitions of care. Our leading Standards Developing Organization (SDO), Health Level Seven International (HL7®) has defined and standardized the use of clinically useful summary documents known as consolidated clinical document architecture (C-CDA) documents.4, 5
ASCO’s Data Standards and Interoperability Task Force, which I chair, has developed two oncology-specific interoperable technology standards. We have taken two ASCO Treatment Plan and Summary paper templates developed for adjuvant breast cancer and adjuvant colorectal cancer6–8 and transformed them into implementation guides (IGs). The IGs can be used to create an interoperable document that can be electronically exchanged between any computer system that adheres to the HL7 C-CDA standard.9 CDAs define content and transport of a document that can be large. This document standard [entitled Clinical Oncology Treatment Plan and Summary (COTPS)] summarizes cancer data from almost all medical reports that are created by physicians, hospitals, laboratories, imaging centers, pharmacies, and patients during the cancer journey and gives review and guidance to the patient and their providers involved with their care. We plan on creating similar C-CDA documents for other common cancers, patient-reported outcomes, and cancer survivorship plans.
At the HIMSS Interoperability Showcase for 2014, ASCO’s COTPS was used to demonstrate how the use of common data elements, standardized reports, adherence to interoperability standards, and use of innovative data entry tools can make provider workflows more efficient and our notes and reports sharable, actionable, and multipurposeful. There, 10 vendors used these standards for exchanging data in real time. Novel data entry tools including voice-recognition transcription to text to data to structured data, a care plan manager, medical devices in the patient’s home demonstrating data capture and alerting capabilities, patient education, patient-reported outcomes and questionnaires, and actionable reports for quality, research, population health, and big data analytic registries were shown. A health information exchange captured and displayed the compilation of clinical reports in real time and made them available to all vendor systems while recording the cancer journey of a woman given adjuvant treatment for her breast cancer. The care plan manager was able to electronically create the ASCO COTPS for the patient, caregivers, and all providers.
HL7 is closer to approving a new, nimble, and simpler interoperability and data exchange standard called Fast Healthcare Interoperability Resources (FHIR).10
