Challenges of the "omics" future and pathology informatics systems: are we--pathologists, clinicians, and consumers--ready?
Abstract: * The health care system is extremely complex and it is currently undergoing a massive transformation with rapid advances in technology. Pathology services have been leading the technology adaptation process and will continue to evolve rapidly with the introduction of "omics" technology. Future pathology informatics systems (PIS) will need to meet the needs of pathologists, clinicians, organizations, community services as well as the expectations of patients, especially given the complexity of "omics" technology. Technology advances, however, often progress at a pace faster than socio-cultural adaptation. A major question therefore arises, "Are we ready?" This article explores the socio-cultural-technical issues and provides a conceptual framework for future discussion about socio-cultural integration in the use of technology to provide a seamless delivery of patient-centered care. It discusses system requirements of future PIS in the context of rapid evolution of medical care. Finally, this article proposes some strategies for the design and implementation of future PIS to achieve socio-cultural-technical harmony in the "omics" era.
Article Type: Report
Subject: Health care industry (Technology application)
Pathology (Practice)
Pathology (Technology application)
Electronic records (Usage)
Medical informatics (Usage)
Author: Yee, Kwang Chien
Pub Date: 06/01/2009
Publication: Name: Archives of Pathology & Laboratory Medicine Publisher: College of American Pathologists Audience: Academic; Professional Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2009 College of American Pathologists ISSN: 1543-2165
Issue: Date: June, 2009 Source Volume: 133 Source Issue: 6
Topic: Event Code: 200 Management dynamics Computer Subject: Technology application; Health care industry
Accession Number: 230152023
Full Text: The health care industry is undergoing one of the most massive transformations ever seen in any industry. (1) There will be an escalation of challenges facing the health care industry in the next few decades. Among these challenges are the proliferation of new technology and clinical information management systems, especially the utilization of shared electronic health records. (2) Pathology service, in combination with sophisticated pathology informatics systems (PIS), is one of the major forces driving changes within the medical world, through the adaptation of new technology. (2) For the next decades, internal and external factors will require us to reinvent PIS for the future.

These factors include both technologic advances and socio-cultural factors.

First, medical care deliveries will experience unprecedented velocity of technology advancement. Pathology services and PIS will continue to lead the transformation of medical care through genomic, proteomics, tandem mass spectrometry, and microarray technologies. (3) The "omics" technology and biomedical informatics will gradually merge and be an integral part of the deep sea of laboratory medicine. Advances in technology, however, come at increased costs to organizations and health care consumers. Many laboratories might not be able to afford these technologies and centralization of testing facilities will become the norm. (4) Second, point-of-care testing devices will proliferate. The accuracy and reliability of these devices need to be vigorously examined. More importantly, capturing and storing the pathology information from these devices might be problematic; there is especially a need to differentiate results from point-of-care devices and results from formal laboratories. Third, the introduction of a shared electronic health record and consumer informatics systems will accelerate the integration of the PIS into shared electronic health records. These challenges will demand an increasing role of future PIS in direct patient care, through dynamic and intuitive integration. The emphasis on patient empowerment and the proliferation of consumer informatics systems will have significant implications for future PIS. Finally, new advances in technology, such as microarray and proteomics, will have significant impact not only in the delivery of diagnostic and therapeutic maneuvers, (3) but also in the workflow of medical practice and ethos of patient care delivery. The introduction of these technologies creates a new level of clinical-pathology interaction. Future PIS will need to cater to the needs of pathologists, pathology scientists, clinicians, and consumers.

While the technical aspect of laboratory medicine will continue to revolutionize the health care system, the associated changes within the socio-cultural context of medical practice are unclear. This article aims to explore socio-cultural issues through the lens of pathologists, clinicians, and consumers; to provide a conceptual framework for future discussion about socio-cultural integration of technology and PIS into the health care system to provide seamless patient-centered care delivery; furthermore, to explore the design and implementation of future PIS to cater to the needs of pathologists, clinicians, and consumers. Finally, the article reveals the barriers and challenges faced by technology and future PIS within the constraints of current organizational and professional structures of the health care system. While the "omics" future might be real from a technologic perspective, we--the health care workers and consumers--might not be ready for it.

ARE WE READY FOR THE FUTURE?

The health care system is arguably one of the most complicated systems created by humans. The difficulties with technology implementation in health care are usually not due to bad programming or poor implementation, but due to the lack of socio-technical integration at organizational and personal levels. (5) The clinical workplace is an environment filled with complex dynamic interactions involving organization, technology, and people. The social and technical factors are codependent for ensuring successful technology adaptation, hence the term socio-technical systems.5 While technology aspects of the "omics" laboratory are advancing rapidly, the socio-cultural aspects of "omics" in the laboratory are less well researched. We therefore construct herein a conceptual framework of the multifaceted socio-cultural aspect of the "omics" laboratory through the lens of the pathologist, clinician, and consumer. Through this conceptual framework, we discuss the design and implementation principles of future PIS.

The Pathologists and the Laboratory

The "omics" era is exciting, yet presents a challenging future for pathologists. Technology advances in pathology laboratory and PIS will ensure that pathology services continue to take a leadership role in the transformation of health care systems. There are, however, many challenges that pathologists and laboratories might face in the future. These challenges include informatics management, organizational management, workforce shortages, and the burden of increasing clinical responsibility.

First, the "omics" era of pathology services will inevitably lead to consolidation of the sector and centralization of testing because of costs.3 Pathologists will need to work within the constraint of available infrastructure, yet maintain a broad base of knowledge. Some of these socio-cultural consequences will mean that the interaction between pathology scientists and clinical staff might change. The hurdle that pathology practitioners have to cross will be to ensure a proper grasp of the new technology by laboratory scientists.

Second, the advancement in technology will exacerbate skill shortages in pathology services. While automation will be common in the future, there will be an increasing need to provide clinical decision support and foster interactions with patients, which will mean an increasing need for pathologists and laboratory scientists.

Third, the "omics" future will require that pathologists have a good grasp of health informatics management. (4) Because of the cost of technologies--geographically driven, and sometimes politically driven--collaboration from different laboratories is the only way to contain the escalating costs of the technology development. (3) The need to transfer information between laboratories will increase rapidly, with an increasing need to share infrastructures. Patients and clinicians will demand real-time data transmission, which could potentially be achieved through automated release of results. Pathologists and future PIS will both need to adapt to these new challenges. Future PIS will have to identify and provide solutions for 3 main areas: security, data integrity, and interoperability. From a security point of view, the security of both the data warehouse for each individual laboratory and the encrypted transmission between laboratories needs to be enhanced. Second, data integrity will become important with an increasing amount of data transmissions, especially if the overall system involves multiple human-machine interfaces. Potential errors could happen at the data entry level, right through to data release. Third, the increase in automation of sample testing and results release across different PIS will only be achievable through a high level of interoperability. Pathology informatics systems need to achieve interoperability at the machine to machine level, machine to informatics level, as well as informatics to informatics level. To adapt to future PIS, information management should become an integral part of pathology training so as to achieve biomedical and clinical informatics integration.6

The Clinician and Clinician-PIS Interaction

From a clinician's point of view, the "omics" future is daunting. There are issues with clinical autonomy, clinical responsibility, professional development, knowledge management, structural organization changes, and workflow changes as well as coping with patient expectations.

First, clinical autonomy and professional skills have been the guiding principles of patient care for centuries. Clinicians adopt "hypothetical-deductive" reasoning, by using laboratory results through Bayesian logic in combination with anecdotal experience and evidence-based decision support systems, to derive diagnostic and therapeutic decisions.7 Within this framework, clinicians enjoy great clinical autonomy, based on their professional skills. The development of the "omics" laboratory, in combination with advanced clinical informatics, biomedical informatics, and clinical decision support systems is a direct challenge to the clinical autonomy enjoyed by clinicians. Clinicians will have to not only face increased workload but also equip themselves with a new understanding of the underlying principles of new technologies. The engagement of clinicians in the development and implementation of "omics" technologies is essential for improving translation of laboratory medicine to bedside clinical practice.

Second, clinicians are already struggling to remember and understand laboratory results without the added complexity of the "omics" technology. Laboratory results are represented by an absolute value and a reference range. Problems arise when different reference ranges are used by different laboratories. Future pathology investigations might involve testing a whole series of genes or protein expressions. The absolute value of each protein is not as important as the pattern of expressions. Advances in "omics" medicine therefore need to be matched with a user-friendly representation of this new knowledge for busy clinicians.

Third, knowledge management will be a major issue for clinicians. The proliferation of research, technology, and intervention will inevitably force the centralization of laboratory testing to ensure cost-effectiveness. (3) Therefore, in addition to a whole list of locally driven, evidence-based protocols and guidelines, clinicians will need to have tacit knowledge about laboratory test availability. The development of new "omics" knowledge will necessitate that clinicians gain knowledge at an increasing speed as the translation interval from experiment to bedside clinical practice will be shorter. The introduction of new technology will need to take into account the training requirement of clinicians.

Fourth, the "omics" era might indicate a change in clinical responsibility. Clinicians will share the clinical diagnostic responsibility with pathologists. In turn, pathologists, armed with expert knowledge in "omics" technology, will have shared responsibility in deciding which tests to perform to derive an accurate diagnosis. This will shift the pendulum of clinical-laboratory collaboration, with pathologists playing a more central role in clinical care. The socio-cultural implication of these changes will need to be managed professionally for best patient care. This shift would threaten the professional boundary between laboratory and clinical medicine and will have significant socio-cultural impact in health care.

Finally, the shifting and sharing of clinical responsibility would bring about a drastic change for the managing of patients' expectations. The current health care structure dictates this responsibility to clinicians. With the increasing role of pathologists in assisting in the diagnosis and management of patients, managing patient expectation would become a shared task. Patient expectations bring out the issue of medico-legal responsibility. With the blurring of professional boundaries, the medico-legal framework would need to be challenged and reformed to reflect these changes in clinico-pathologic interactions.

Future PIS can alleviate some of these concerns through clinician-centered design. With technology advances, clinicians might no longer have an in-depth understanding of basic testing principles used by pathology services, and the traditional Bayesian logic might also be challenged. (7) With the increasing number of possible genetic combinations with microarrays as well as the increasing number of protein analyses, pathologists will play a more important role in providing clinical decision support. First, diagnostic and therapeutic challenges during clinical encounters will need to be communicated to pathology services through PIS in a universally accepted set of taxonomies to determine the most valuable and relevant investigations. The results of these investigations will be communicated back to the clinicians in an easily understandable way through socio-technically integrated knowledge representation. Future PIS will therefore need to cater to clinicians as well as pathologists. Essential issues include diagnostic decision support, knowledge representation, knowledge delivery, and therapeutic decision support. Ideal PIS should be able to extract essential data out of the clinical informatics systems for pathologists. The PIS will also release messages to clinicians in a standardized data presentation method. This means that only 1 universal set of taxonomy and messaging standards will exist within the health care system, which is only achievable with a dynamic and seamless integration of PIS into shared electronic health records.

Consumer and PIS-Consumer Interaction

From a consumer's perspective, the advances in medicine will bring about faster diagnosis and better treatment. However, many issues need to be considered for the introduction of the "omics" future and seamless PIS. Consumers expect primary care providers to provide most of the care in the community. The expectation is for a seamless transmission of information to and from primary to tertiary care center, but concerns surrounding the issue of confidentiality, privacy, and security exist. (8) The widespread availability of digital media provides worldwide information on data security and privacy. Stories of hacking and identity theft are so common that almost all consumers would be aware of these issues. This is especially important in the "omics" era. While direct consumer data presentation might be important, ensuring that the information reaches the "right person" is difficult, especially with mobile and wireless technology.

Second, most consumers want to have a basic understanding of the world, especially of the medical world as it relates to their own health. The development of digital media, Internet, and wireless technology has already created an environment in which consumers have no real understanding or no real control of the technology used in these devices. With the "omics" development, a medical world that is completely foreign and incomprehensible to many consumers will conflict directly with patient empowerment principles and patient-centered care movements.

Third, consumers, with variability in their expectations of medical care, form a diverse group. Some would want full access to all medical results, while others trust that their clinicians will manage them appropriately. Availability of information will need to be an option for all consumers. Many consumers would want to know the meaning of pathology tests, and consumers ask that health care professionals explain these results in an understandable way. While real-time release of data to everyone, including consumers, is achievable through well-designed technology, the outcome might be an increase in consumer anxiety and health care utilization.

Fourth, technology often brings about unexpected consequences; the same applies to genomic technology and proteomics analysis. The examination of genetic sequences carries significant bioethical, social, and cultural implications. From a bioethical standpoint, patients will lose individual power to decide whether they want to know their genomic structures. The analysis of human genome through laboratory testing has the potential to create data warehousing and data mining in the discovery of new knowledge. (9) From a utilitarian point of view, this action is justifiable. It is, however, important to realize that the individual right of consumers is breached in the process of knowledge discovery. From the socio-cultural standpoint, the availability of genomic analysis might reveal some important yet unacceptable "facts." Do you really want to know that the people you call mom and dad are not your parents after all, all this because you broke your ankle and required analgesia?

Finally, a trusting relationship with one's clinician is a healing relationship. For healing, consumers need more than sophisticated machines and statistical probability. The "omics" laboratory will challenge the fundamental patient-doctor relationship. Consumers will increasingly use the Internet and other resources to search for available tests for their "suspected" conditions. The management of this relationship will be challenging for both clinicians and consumers.

From the perspective of future PIS, patients will most likely request access to their results and argue for their ownership. These results, however, might not be easy for patients to interpret or understand. Future PIS will need to address individual consumer needs, through the availability and interpretation of data, while ensuring the privacy of patient information. This is a great challenge.

HOW CAN WE PREPARE OURSELVES?

With the "omics" technology, many socio-cultural issues confront pathologists, clinicians, and consumers. While the future is unpredictable and more issues will almost certainly surface in the next decade, this article seeks to develop a conceptual framework as a foundation for future discussion about the socio-technical impact of new technology as well as the requirement of future PIS. Currently, many PIS seem to function in parallel fashion to clinical informatics systems. In most hospitals, the filing of pathology results and of clinical notes for the same admission is often separated in time and space. Many challenges exist while attempting to combine these 2 information systems. The full integration of PIS with clinical informatics systems will be necessary but challenging. Pathology informatics systems in their current forms serve slightly different purposes than clinical informatics systems. We believe, however, that we will need to build an integrated clinico-pathologic system to cater to future needs. We can better prepare for the future if we start to understand the potential impact of technology advances through the holistic socio-cultural-technical lens.

There are some potential strategies to minimize these socio-cultural impacts. The first is to provide education and training in medical and health informatics for pathologists and clinicians. Health informatics should be included in the traditional medical courses (10) and pathology informatics should form a part of the pathology training program. (11) Some education and training programs have reported great successes. (6)

Second, technology implementation in health care should have user-centered and socio-technical evaluation criteria. These insights from users, especially from consumers, about information technology and especially the implementation of PIS, are invaluable for future developments. Furthermore, socio-technical evaluations should be standard evaluation criteria for all technology implementation projects in health care. This will allow better understanding of the potential impact of technology on socio-cultural factors as well as the impact of socio-cultural factors on technology implementation.

Finally, the design and implementation of technology and PIS demand early involvement of end-users. Given the uncertainty about the impact of technology on health care systems, the journey toward technology implementation should be perceived as a process of learning with pathologists, clinicians, and consumers. The knowledge and lessons learned through the implementation process should be well distributed; they should be shared among and presented widely from the perspective of pathologists, clinicians, and consumers.

The socio-technical aspects of "omics" medicine presented herein provide the foundation for future discussion. The recent First World Congress On Pathology Informatics provided the essential platform to engage pathologists, clinicians, consumers, and pathology informatics enthusiasts in a debate, as well as to share knowledge and valuable lessons to equip us for the challenging future.

CONCLUSION

The health care system is facing its biggest challenge and going through a rapid phase of transformation. The "omics" technology and future PIS will lead the medical world during this transformation. Future PIS need to cater to all parties, from organizations, clinicians, and pathologists to communities and consumers. However, many socio-cultural issues that involve pathologists, clinicians, and consumers need to be addressed. This article provides a conceptual framework to discuss and address these socio-cultural-technical issues. Some strategies proposed might help us gain a better understanding and prepare us for the future. Most important, research and discussions surrounding the socio-technical aspect of the "omics" phenomenon are urgently needed. Pathologists, clinicians, and consumers need to actively participate in the design and implementation of PIS and in the debate about socio-technical issues as well as in the integration of PIS into shared electronic health records. The recent First World Congress On Pathology Informatics provided a platform for engaging all parties in a healthy debate and discussion. The future is exciting and challenging, we need to get ready for it!

The author would like to acknowledge the assistance of Ms. Ming Chao Wong, Associate Professor Paul Turner, PhD, and Associate Professor Udayan Ray, FRCPA, in the preparation of one of the manuscripts presented at the First World Congress On Pathology Informatics. That manuscript has assisted the preparation of this paper.

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Kwang Chien Yee, MBBS (Hons), BMedSc (Hons)

Accepted for publication October 16, 2008.

From eHealth Services and Research Group, University of Tasmania; and the Department of Gastroenterology, Royal Hobart Hospital.

The authors have no relevant financial interest in the products or companies described in this article.

Presented in part at the First World Congress On Pathology Informatics in Brisbane, Australia, August 16-17, 2007.

Reprints: Kwang Chien Yee, MBBS (Hons), BMedSc (Hons), eHealth Services and Research Group, University of Tasmania, Private Bag 87, Hobart, Tasmania, Australia 7001 (e-mail: kwang.yee@dhhs.tas.gov. au)
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