On behalf of the Deputy Editor, Associate Editors, Editorial Board, and the journal staff, I wish to warmly welcome you to the inaugural edition of The Journal of Applied Laboratory Medicine (JALM). The focus of JALM will be translational laboratory medicine, a term that is intended to encompass the elements of timeliness, pragmatism, relevance, and quality. The aim of this editorial is to welcome readers and provide a short overview of the philosophy and content of this peer-reviewed publication.
In addition to full Original Articles, JALM's content will include Focused Reports, which are brief articles that concentrate on a particular issue. Also, Case Reports will be a regular JALM feature; for many cases, there will be an emphasis on unusual interferences and findings of interest to members of the laboratory community. To mention one other contribution format, JALM will serve as a forum for Laboratory Reflections. This category will include Professional Insights that are perspectives from experts on key topics in the field, Technical Tips that offer advice on how to address laboratory challenges, and Pay It Forward, which is intended for sharing advice, experience, and resources on topics such as mentoring, training, and teaching. The above is not intended as a comprehensive listing of JALM's intended content, but rather a taste of what can be expected.
Measurements matter because the characteristics of tools used to provide laboratory medicine information are frequently determinants of patient outcomes. One example is illustrated by a controlled before-and-after study conducted by Mills et al. (1) in their efforts aimed at determining if lowering the diagnostic threshold for myocardial infarction of a sensitive cardiac troponin assay could improve clinical outcomes. This study compared use of the cardiac troponin cutoff of an earlier generation assay with the intervention of using a lower threshold near the 99th percentile of a reference control population. This step was only possible with use of a more sensitive contemporary generation cardiac troponin assay. The “after” cohort for which the intervention lower cutoff was used showed improved outcomes of between 21% and 39% in terms of death and recurrent myocardial infarction in patients having troponin concentrations in the “window” between the earlier generation troponin's higher diagnostic threshold and the lower cutoff. Of course, measurement with a more sensitive cardiac troponin assay and guideline-recommended decision point alone does not improve outcomes. Rather, the improved information allowed clinicians to better identify patients at risk and implement management strategies known to improve the outcomes of myocardial infarction patients. This way, the cardiac troponin was a companion laboratory medicine procedure that assisted in guiding the management of these patients toward improved health outcomes.
The information promulgated in JALM will consist of findings and applications that are in the translational continuum between being available in laboratory practice today to availability within the next 7 years. Publication will be timely, meaning that contributions submitted to JALM will be handled efficiently and will be accessible to the scientific community expeditiously. It is important to note that this does not mean JALM will trade quality for speed of dissemination in any way. Contributions will be available online only after they are approved by both the JALM editorial staff and the submitting authors.
JALM will use the principles of evidence-based medicine that have been established for over 2 decades. Evidence-based clinical practice has been accepted in most health systems around the world and can be used in laboratory medicine (2). Variations of the “A6 cycle” of asking the right questions, acquiring the evidence, appraising it, analysis of the available information, applying the findings to practice, and auditing the outcomes have become fundamental to processes for determining what is effective in the laboratory medicine field (3). Submitted manuscripts that involve systematic reviews, evidence-based guidance, best practice recommendations, and guidelines will be received gratefully by JALM. We must all keep in mind that the sine qua non for evaluating the clinical value of using new diagnostic tests and strategies depends on whether it improves patient outcomes beyond the outcomes achieved using the old diagnostic test (4). Thoughtful assessment of laboratory testing must also remain cognizant of the economics of providing laboratory output; reports on how laboratory services can be produced more efficiently and effectively will be increasingly important in the future. Appropriate utilization of laboratory medicine tools and “utilization review committees” at the institutional and health system levels are playing an ever-increasing role in providing clinically effective and cost-effective laboratory medicine services. A topic that has been of keen interest regarding analytical performance and clinical effectiveness has been laboratory-developed tests. Many laboratory-developed tests were created in response to an unmet need, especially for rare diseases where limited laboratory medicine resources are available. One critical issue is proper validation that these assays are safe and effective for use in patient care. JALM will assist by being a venue for disseminating analytical and clinical evidence for such assays. The heart of these efforts is information that can be trusted; thorough evaluation and dissemination of evidence is one of JALM's core goals.
Regulation is an area that is front and center in the laboratory medicine field. The Center for Medicare and Medicaid Services, CLIA, the Occupational Safety and Health Administration, and the Food and Drug Administration are only a few of the bodies with regulatory responsibility in the laboratory medicine space. In particular, the Food and Drug Administration is charged with assuring that the devices available and implemented for patient care are both safe and effective. One might maintain that this is a natural setup for controversy and confrontation between regulators trying to do their jobs, innovators who passionately believe that their products will benefit the public health, and the manufacturers who would like to add new products and improvements to their portfolio of merchandise available for patient care. JALM wishes to play a constructive role by assisting all of these groups by providing information that is reliable, unbiased, and trustworthy.
Relevance is valuable. Increasing efficiency and focus on the [volume/cost] relationship for delivering laboratory services has been a consistent pressure that many believe has contributed to laboratory medicine looking inward, rather than taking an integrated, more valuable approach with stakeholders that includes patients, the folks who care for them, medical specialties, administration, institutional leaders, payers, and policymakers. This tendency toward an inward focus, self-interest, and cost-per-volume has increased the risk of diminishing the relevance of laboratory medicine and its professionals. This mindset is often represented by the (perhaps overused) metaphor of a “silo.” The silo phenomenon is intended to signify fermentation within and limited interaction with the world outside of the confining walls. In contrast, relevance and value is expressed by the [benefit/cost] ratio and includes the total testing process both inside and outside the walls of the laboratory. Although all healthcare groups are concerned with the health outcomes of patients, the “benefit” numerator that the various stakeholders find most valuable varies substantially with their role and perspective. For laboratory services (and professionals) to remain relevant, they must identify and understand what benefits different stakeholders are looking for and work to resolve unmet needs for the various groups. Accomplishing this requires innovation, and disseminating these innovations is of keen interest to JALM.
When considering the quality of scientific papers, there are specific tools that should be used depending on the study's aims and design. One of these tools includes the Standards for Reporting Diagnostic Accuracy (STARD)2 checklist for addressing important aspects in diagnostic accuracy studies. The STARD document was initially published in 2003 and then updated in 2015 to incorporate recent evidence about sources of bias and variability in diagnostic accuracy and to facilitate use. The stated aim of the document is to improve the quality of reporting of diagnostic accuracy studies that consider such characteristics as sensitivity, specificity, predictive values, and/or area under the receiver operator curve (5, 6). As with many high-quality publications, diagnostic accuracy reports published in JALM will adhere to the STARD recommendations. Further, diagnostic studies and other contributions to JALM will explicitly address the total testing process, which includes the preanalytical, analytical, and postanalytical phases. Evaluation of the analytic phase is critical; however, it is vital to systematically evaluate the other two phases because the preanalytical phase is reportedly responsible for 46.0%–68.2% of laboratory medicine errors, and the postanalytical phase is associated with 18.5%–47% of errors (7). JALM believes that specifically addressing error in all phases of testing will help minimize risk to patients.
The path forward for laboratory medicine will involve strategies for collaborating, communicating, and integrating with all healthcare stakeholders. There are many ongoing efforts and activities throughout the world toward this end. JALM endeavors to play an active role in disseminating innovation, enhancing the value of laboratory medicine and its professionals and fulfilling unmet needs. All those involved with JALM are looking forward to enthusiastically engaging users and contributors of this resource and playing an active role in the evolution of laboratory medicine.
↵2 Nonstandard abbreviations:
- Standards for Reporting Diagnostic Accuracy.
Authors' Disclosures or Potential Conflicts of Interest: Upon manuscript submission, all authors completed the author disclosure form.
Employment or Leadership: R. Christenson, JALM, AACC.
Consultant or Advisory Role: None declared.
Stock Ownership: None declared.
Honoraria: None declared.
Research Funding: None declared.
Expert Testimony: None declared.
Patents: None declared.
- Received April 20, 2016.
- Accepted April 20, 2016.
- © 2016 by American Association for Clinical Chemistry