The Creation of Point-of-Careology

Abstract

Goals 

The objectives of this study were to improve awareness of point-of-care testing as a new medical field, to solidify relationships among point-of-care professionals and other medical disciplines, and to identify potential for advancing medical applications, economic benefits, and patient impact through timely decision-making for evidence-based medicine.

Methods 

Literature review, comprehensive analysis, focused analysis, inductive logic, general summary of international outcomes, and comparative advances that improve point-of-care impact in China and other countries in need of rapid response were performed in this study.

Results 

The creation of point-of-careology comprised the following: (a) introduction of its research and practical scope, (b) appropriate definition of this new field, (c) description of the range of applications, and (d) identification of relationships with other disciplines.

Conclusions 

Point-of-care testing now is being written into a professional textbook in medical schools in China. Point-of-careology is the outcome of evolution in intelligent diagnostics. Notable achievements in critical care medicine, emergency response, and general practice have resulted from the implementation of point-of-care testing over the past 4 decades. As a new discipline, point-of-careology will contribute to key medical areas, such as disaster preparedness and public health, which we explore. The creation of this new specialty is justified by trends in modern medicine with improved service to the public and by parallel technological advances that empower health care providers at sites of need to deliver complete care cycles quickly and effectively.

Scope

Traditional laboratory testing requires substantial protracted time to produce results in China. To decrease therapeutic turnaround time (TTAT), the time from ordering or performing a test to treating the patient, medical staff have engaged and increasingly are using point-of-care testing (POCT). Through numerous proven applications, POCT can quickly produce test results, improve therapeutic decision-making, and reduce the economic burden of health care for the Chinese population. As a result, POCT has been accepted by patients and medical staff and now is widely used in emergency medicine throughout China.

Disciplines

Medical and surgical disciplines who now have engaged POCT comprise cardiology and cardiovascular surgery, intensive care, pediatrics, gynecology, oncology, hematology, blood transfusion, military, bioterrorism, fire, and emergency rescue, and others. Point-of-care testing is used on-site in each of the above, with test results connected to various networks throughout small-world networks (SWNs) in China. This connectivity, which is increasing in scope, garners tremendous social and economic benefits, which return value for on-site health care, decision-making, strategic optimization, and enhancement of standards-of-care.

Resilience

Point-of-care testing can improve work efficiency in SWNs and patient satisfaction, optimize medical benefits and increase economic benefits, and, importantly, increase the resilience of health care SWNs and various medical service systems, thereby improving public health administration and equity. In the United States and other countries with high gross national products, POCT has become ubiquitous where rapid response is paramount. In fact, reports about point-of-care (POC) have appeared in the several countries, and POC, which has been written into a textbook in medical colleges and universities, appears in China.¹ Point-of-care testing curriculum and accreditation have been proposed at US public health schools with detailed contents listed.² These advances portend significant future contributions to community health and resilience in times of need.

Curricula

The curriculum in China focuses mainly on students of public health and laboratory tests in specialty training but is expanding to cover training skill sets for medical and health causes. Critical point-of-care testing plays an active role in emergency medicine, intensive care, disaster medicine, monitoring outbreaks of infectious diseases, and neonatal emergencies, similar to progress in the United States, and during recent epidemics, also in Africa. We feel that codification of this new specialty will strengthen and promote further progress in educational curricula, which in turn will enhance understanding of the principles and practice of POCT leading to more efficient and effective harmonization.

Trends

In this rapid development era, with disasters, terrorism, and sudden illnesses occurring more frequently, POC practice follows a natural trend. Rich theoretical basis and a practical knowledge have accumulated in the development of POC to justify its practice as a new field. Therefore, we view it as a new discipline of theoretical and practical knowledge and strive to pass this knowledge on to people in academia, industry, and professional practice. Our approach is pragmatic in that it aligns with the major trends in medical care closer to where patients live and work.

Orientation

This article focuses on the origin of point-of-careology and its definition, scope of study, research purposes, and patient applications. The field of point-of-careology covers a wide range of medical and societal areas, as illustrated in Figure 1. This new discipline must push toward a broader scope of application and orientation befitting advanced miniature and handheld technologies now in the research, development, and commercial pipeline. With appropriate anticipation, point-of-careology will garner support and funding for education, research, and clinical applications (Table 1).

FIGURE 1: Point-of-careology. Small-world networks, home, village, and community hospital connect with province hospital, connect with province referral hospital, connect specially with university and national centers; disaster cache, the office of the Assistant Secretary for Preparedness and Response under the United States Department of Health and Human Services maintain 3 strategic mission support centers located in the western, central, and eastern United States.

TABLE 1: Future Implications and Impact of Point-of-Careology in China

METHODS

Through reading numerous sources, analyzing available resources, and comparing POC and laboratory techniques (Table 2), we confirmed that the conceptual basis of POCT and laboratory testing differs substantially, which is the rationale for defining this expanded and specialized scope of a new field.

TABLE 2: The Differences Between the POCT Technique and the Laboratory Technique

RESULTS

Evidence-Based Medicine

Core biochemical indicators comprise the following: the balance of water, sodium, potassium, ionized calcium, chloride, magnesium, and other electrolytes; acid-base and pH homeostasis; oxygen saturation, pO₂, and pCO₂; liver and kidney function; protein and enzyme indictors; glucose metabolism and diabetes markers, such as HbA1c; lipid metabolism and cardiovascular disease markers; tests for coagulation status, such as active coagulation test, prothrombin time, and activation of partial thromboplastin time, and fibrinogen and fibrin degradation products; tumor markers; indicators of kidney function, such as creatinine and urea nitrogen, and so on,^3,4 ideally coupled at the point of need with microbiology and infectious diseases tests. These tests generate core indices for clinical understanding of the patient's health and also make up an important part of modern evidence-based medicine, especially in cases of rapid response or support of critically ill patients with highly infectious diseases, such as Ebola virus disease.

Discovery of POCT

In 1972, Dr Kost⁵ began the study of biosensors and monitoring of pH changes under cardiopulmonary stress and shock in vivo. He conceptualized the new field of patient-focused testing in original visual logistics describing clinical pathophysiology.⁵ Earlier in 1955, hematology testing manuals had documented on-site patient care brought up in England.⁶ Then, in the early 1980s, Dr Kost⁷ coined the term, point-of-care testing, while performing biosensor-based serial measurements of ionized calcium in whole blood at the bedside of patients undergoing hepatic transplantation at the University of California, Davis, Medical Center.

Dr Kost personally performed whole-blood analysis directly in the operating room at the patient's side and immediately reported results to the anesthesiology and surgical team, who then acted on them. At the time, the key discovery was the pathophysiological disassociation of ionized calcium from total calcium as a result of the chelating effects of massive blood transfusion needed to support patient vascular volume in the early days of hepatic transplantation.⁷

By means of real-time POC trending in the operating room, he proved that ionized calcium could not be calculated accurately using multiparameter correction formulae, nor could it be estimated. It had to be measured directly and rapidly in whole blood using a biosensor-based Ca²⁺ (Na⁺ and K⁺) instrument, and time was of extreme essence. With therapeutic turnaround time minimized at the point of need, the anesthesiology-surgery team was able to act on results immediately to support patient cardiovascular function. To this day, POC rapid response has proven pivotal to timely evidence-based medicine during patient crises.

Significance of POCT in Critical Care

Kost's work proved to be one of the most important advances in POC, namely, the discovery of the pathophysiological importance of acute ionized hypocalcemia, the “fifth electrolyte,” for sustainable cardiovascular function. In association with that, Dr Kost delineated, first by hypothesizing and then later by confirming with national surveys, the critical limits for ionized calcium, which are in use today as decision thresholds.⁸ A few years later, the term, point-of-care testing, was codified by a collaborative team, known as the Cape Cod group, after the location of the meeting of critical care and clinical pathology/laboratorian leaders in America, as summarized by Kost et al⁹ in the journal Chest. Thus, critical point-of-care testing became a core driver of the paradigm shift to diagnostic testing and patient monitoring at the POC.

Impact of Codification

The goal of the Cape Cod group was to simplify the definition of POCT as, “Testing at or near the site of patient care.” This now is the accepted definition and was entered in Wikipedia initially and originally by Dr Kost and colleagues at the POCT•CTR (see https://en.wikipedia.org/wiki/Point-of-care_testing). Unknown editors have changed somewhat this original definition in Wikipedia, but the essence of the original meaning remains.

Thus, after several years of maturation, the timing is right to propose that the field become recognized as a specialty spanning both the medical and surgical arts and, in fact, a field intrinsically born as a collaboration of these physician groups with the support of technology invention, on-site decision-making, and rapid response. In view of its mobility, POCT has grown to serve patients most in need of help, such as in limited-resource settings¹⁰ or threatened with highly infectious diseases.¹¹

Globalization of the New Field

Numerous technological advances facilitated global extension of POCT to become ubiquitous worldwide, a fact illustrated by recent books,^12,13 as well as by exponential expansion in heavily populated countries, such as China. These aggregate advances in clinical knowledge have garnered and justify the innovation we propose, namely, proper designation of point-of-careology. This designation will accelerate future progress, especially in upcoming generations of medical students, who will emerge later in this 21st Century as professionals equipped with POC devices for immediate evidence-based diagnosis, patient monitoring, and therapeutic decisions along with smartphones for big data connectivity. These are the new point-of-careologists or simply for short, POCologists.

Timeliness as a Key Attribute

Over the years, a variety of guidelines on patient bedside testing have been proposed.^14–17 In 2000, different standards were proposed,^18–23 which provided a more-or-less uniform basis for the use of POCT. As noted earlier, the basic meaning of POCT is testing performed at or near the site of patient care, or in the hospital, at the patient's bedside.⁹ In this regard, there is a medical and economic efficiency inherent in this progress. Because it is performed at the site of patient care, it shortens the treatment interval, that is, TTAT, which is defined as the duration of time from when the physician or other responsible care provider conjures the test and orders it to the time of treatment.

Supporting Advances

Quality control and project management represent essentials for the sound practice of POCT.^24,25 Clinical Laboratory Improvement Amendments '88 played a key role.^26–28 With the fundamental goal of improved quality, it divided testing systems, even if somewhat arbitrarily, into 3 categories: exempt, moderately complex, and highly complex. After several years of clinical practice, POCT matured substantially.

In 2002, Kost²⁹ published the contributed book, Principles and Practice of Point-of-Care Testing, which summed up the experience in this area. Kost²⁹ produced a POCT monograph in Bahasa Indonesia for that island nation and contributed to a book in the Thai language for Thailand. In 2006, Liu et al³⁰ introduced this concept in China in the first Chinese language book, which was titled, POCT: Basic Theories and Clinical Practice ().

A major objective of these tomes was to provide integrative education in the fundamental theories, principles, and practice of POCT or, we would now say in retrospect, the embryonic knowledge base for point-of-careology. AACC Press published review monographs and updates and 2 new seminal books that emphasize the global and disciplinary expansion of POCT appeared more recently, Global Point of Care: Strategies for Disasters, Emergencies, and Public Health Resilience¹² and A Practical Guide to Global Point-of-care Testing,¹³ both of which codified the disruptive advantages of POCT. Additional evidence of progress rests in 2 national guidelines that have been produced, one by Malaysia (in English) and the other by Thailand (in Thai).

The sum total of this intellectual progress motivates us to propose the new specialty of point-of-careology. Furthermore, Kost et al¹ now strongly recommends, based on a 2018 national survey of all schools of public health in the United States and of all states that offer public health training, which showed that POCT is not taught to emerging public health professionals, that public health educational institutions in the United States and other countries teach the principles and practice of POCT. Hence, 2 major nations, China and the United States, are benefiting from the advantages and progress of POCT, and as well, other countries have or are expected to soon follow suit and add substantial value to health care delivery at points of need worldwide.

DISCUSSION

Positioning Point-of-Careology

Point-of-care testing directly involves doctors and nurses. Doctors give directions, and then nurses and associated personnel carry out the doctors' advice. They all work together as a team and now should embrace a new team member, the point-of-careologist, who can provide technical and interpretive expertise for bedside diagnosis. Point-of-care testing in China became more accepted in 2013.³¹ A goal of point-of-careology is to organize, integrate, coordinate, and standardize resources to guide POCT. The operation of POCT in turn provides feedback to improve future technologies and the rational allocation of resources. Point-of-care has established itself in 3 arenas: healthy population monitoring and long-distance medical systems; health care systems and SWNs; and intensive care, emergency medicine, and crisis resources (Fig. 2).

FIGURE 2: Origin of point-of-careology. Long-distance medical systems use information and telecommunications technology to exchange experts opinions and clinical data of patients from far away places. This figure can be viewed online in color at www.poctjournal.com.

Vital Role in China

In China, POC technology applied to the SWN and remote network systems integrates future technologies and can be the basis for allocation of funding and resources. It improves the standards of care in crisis, thereby enhancing the resilience of a region or the state's ability to recover people's livelihood and health in event of biological emergency or disaster treatment. Therefore, as POC culture began to arise, knowledge of how to use this technology to solve problems in health emergency, disaster, and crisis response followed suit. In 2015, Kost et al¹² proposed the global initiative to integrate health care policy, including emergency, public health crises, and revitalization of community resilience.

Natural Blending of Historical Precedents

Point-of-care testing and POC professionals need to improve collective awareness, to solidify relationships with other medical disciplines. With the precedent of immediate medical results and economic benefits in China, point-of-careology reflects the outcome of development of POCT and the professionals who perform it. Because evidence-based medicine uses objective testing results as the basis for medical decisions, on-site medical science has changed the approach to obtaining data instantly, accurately, and efficiently.

Timely medical data can be used for on-site medical decisions. Point-of-careology needs further international collaboration to bring it into light, in view of rapid advances in POC molecular diagnostics and initiatives like the Grand Antimicrobial Resistance Challenge, which offers a US $20 million prize, the largest ever awarded by the United States government, meant to bring pathogen detection and selection of effective antimicrobials directly to points of need.

Codified Definition of Point-of-Careology

Point-of-careology is defined as the practice of physicians, nurses, and other professionals working with the guidance of handheld, portable, and transportable technologies that detect disease markers and vital indicators optimized for diagnosis and treatment directly and immediately at points of need. In China, it also includes the detection of food and environmental hazards by technicians under the guidance of food and drug monitoring department with POCT, resulting in countermeasures of control. In other words, point-of-careology represents a new field of medicine that uses mobile technologies directly at the scene or at the bedside of the patient or where the patient needs to be, holistically, within the entire medical or health care cycle (Fig. 3).

FIGURE 3: Point-of-careology definition. This figure can be viewed online in color at www.poctjournal.com.

Purpose and Rationale

The main purpose is to shorten the treatment cycle time (TTAT) to produce the best medical outcomes and socioeconomic benefits. Point-of-care testing matches the fast-paced and mobile life style of people today. The ensuing POC culture maximizes the interests and expectations of healthy people and patients alike, victims of disasters and emergencies, and critical care patients treated in a timely manner to minimize harm. Detection of human health, disease, medicine, food, and environment ensures human safety and quality of life.

Rapid, accurate, and safe field detection will produce good health effects and socioeconomic benefits in China. Large sets of data should be collected and sorted to lay a foundation for reference values of the field diagnostic examination. Because results of field medical examinations are not comparable with those of the laboratory test (Table 2), reference values of the field medical examination system should be established.

Point-of-Careology Research

Point-of-careologists must collect, edit, and evaluate large amounts data as reference basis for on-site evidence-based decision-making, because of the difference between the results of field testing and laboratory testing (Table 2). Therefore, point-of-careology as a specialty must harmonize reference values, subject differences, decision thresholds, and critical limits for its own detection system. Considerable research effort will be required.

Emerging POC culture requires acceptability by physicians and patients, suitable models of management, and advances in POCT for both inpatients and outpatients. We must strengthen studies on the performance of POCT instruments and quality control. Investigating acceptability by patients and healthy people will play a role in novel future applications. Studying POC will help optimize strategies for emergency medicine and disaster medicine and will help revitalize public health and community resilience in China.

Relationship to Other Disciplines

As a new interdisciplinary field, point-of-careology must connect efficiently with infectious disease experts, gynecology and obstetrics, cardiovascular medicine and surgery, disaster response, emergency medicine, and other facets of modern practice. When using POCT, traditional epidemiology, pathology, laboratory methods, diagnosis, and treatment of diseases must be integrative, to generate timely economic benefits for patients. In addition, future applications must consider management of point-of-careology, its informatics, and public health impact. The specific content and classification of point-of-careology are delineated in Table 3.

TABLE 3: The Subject Classification of POC^12,32–34

For example, Jonny et al³⁵ proposed that using POCT to detect urine lipoarabinomannan, can guide tuberculosis, treatment decisions for HIV positive patients. Implementation of POC lipoarabinomannan testing may offer the greatest benefit to hospitals with the scarcest diagnostic resources and to patients with severe disease and advanced immunosuppression, as well as to patients who cannot cough up sputum.

In another example, Marissa et al³⁶ proposed that POCT of troponin I or troponin T plays an important role in the diagnostic treatment of acute coronary syndromes, especially to rule in the diagnosis. Cardiac Troponin POC bedside detection in Canada reduced test turnaround time and accelerated treatment. Emergency room, small- and medium-sized hospitals, rural health care centers, and remote areas benefit from this integrative approach at points of need.

FUTURE VISION—A NEW FIELD AND SPECIALTY

• Point-of-care testing has proven itself in epidemics, disasters, emergencies, hospital surgical practice, intensive care, bedside decision-making, and personal health maintenance, including self-testing, over recent decades. Point-of-careology is the outcome of this development of POCT and the POC professionals who perform it worldwide.
• This new specialty will assure its quality, integration with spatial care paths, and fundamental research assessing the value of numerous new POC technologies that advance to the bedside.
• As a new discipline in China, point-of-careology will enable on-site diagnosis and evidence-based medicine to develop synergistically. On-site point-of-need health care is characterized by a close relationship to the patient, improved outcomes, high nursing standards, and reduced medical costs, which enable practical public health in China, a vast country with burgeoning population.
• Point-of-Careologists will define standards of care, test reference values, and best practices in each setting and country. They will provide valuable leadership for the harmonization of POCT.
• The creation of point-of-careology reflects advances not only in modern medicine and technology but also in societal expectations in general, essentially in parallel to the advent of smartphones and other convenient devices that people can acquire easily.
• Point-of-careology reflects several key advantages of POC systems, including but not limited to (a) enhanced access by the patient at sites of care closer to the home and primary care; (b) improvements in the marginal value of testing and time savings in proportion to the severity of the medical crisis; (c) simplicity and speed with new modalities of testing on ambulances, airplanes, ships, and other mobile carriers; and (d) reliable results that eliminate the time obsolescence of transported or stored specimens.
• Point-of-careologists will enable POCT to support integrative medical programs, which in turn is more conducive to the systematic learning of Chinese people. Attention should be paid when teaching point-of-careology to (a) learn the theory and technology of POCT; (b) systematically study the requirements for quality control, reference values, and environmental conditions; and (c) strengthen both the guidance of the hospital clinical laboratory and the operational standards of bedside performance under the leadership of the hospital or health care network professional committee.
• With the progress of science, technology, and professional education, point-of-careology in China and other countries has a wide horizon and bright future.