Abstract
The International Journal of Biological Markers (IJBM) has been focusing on circulating biomarkers in solid tumors since its foundation in 1986. In the last few years a substantial number of manuscripts on a multiplicity of novel biomarkers have been submitted to IJBM, whereas the interest in “traditional” tumor markers (TMs) such as CEA, CA15.3, etc. seems to decline, as if the clinical role of traditional TMs were clearly established. If this were true, then traditional TMs would be expected to be appropriately used. However, recent studies have shown that the number of ordered TMs is considerably higher than expected and TMs are frequently inappropriately requested (1, 2). With approximately 13 million TM requests per year in Italy (1), serious consequences are predictable both for individual patients – high overdiagnosis rates – and the health care system – overload with unnecessary testing (3). In spite of the availability of clinical practice guidelines (CPGs), TM ordering rates have remained higher than expected over the years (1, 2). Globally, it appears that health systems fail to optimally adopt evidence in circulating TM use (2).
The development of strategies to implement CPGs falls into the area of research defined as “knowledge translation” (4). In the case of circulating TMs, this area encompasses several issues, including guideline implementation and identification of questions requiring further research (4). IJBM is evaluating the opportunity of launching in 2017 a call for papers dedicated to knowledge translation on circulating TMs, in hopes that this will contribute to narrowing the gap between the rapidly growing knowledge and the clearly still ineffective clinical application of TMs.
I am therefore pleased to open this field of interest of IJBM with the publication of the English version of a guidance document aimed at assisting in the implementation of CPGs regarding the clinical use of TMs. The document was published in Italy in October 2016 by the Italian National Agency for Regional Health Services (AGENAS) on behalf of and in collaboration with 9 Italian scientific societies representative of a variety of stakeholders (5). The project was planned and managed by the Regional Center for Biomarkers of Venice, which coordinated the teamwork of an expert panel of 74 members. The guidance document in English will be published in 3 parts; the first part, appearing in the present issue, concerns the malignancies of the gastrointestinal tract; two other parts will follow in 2017.
The project was grounded on the awareness that different CPGs may assume different positions on the same clinical question; in fact, some CPGs formulate recommendations while others do not, or there may be poor consistency between recommendations put forward by different CPGs. We therefore developed a tool to summarize the information on circulating TMs offered by the available CPGs on solid tumors, using a structured and rigorous methodology. The goal is to supply health care providers and policy makers facing clinical questions where the use of a TM could be considered with all possible evidence-based choices. Recommendations were extracted from CPGs and ordered by individual malignancies. They were clustered according to a set of clinical questions and summarized, at increasing levels of synthesis, into Detailed Summary Tables and Take-Home Messages. The Take-Home Messages are addressed to health care providers to improve the appropriate use of TMs in clinical practice. The Detailed Summary Tables are mainly addressed to health care organizations and policy makers for potential adaptation to their own context, as well as to educators to help them design teaching programs consistent with the available evidence. The expert panel did not attempt to harmonize or interpret discrepant positions on a clinical question by different CPGs. In fact, while highlighting issues where poor consistency between guidelines was found, this guidance document provides an inventory of all possible choices within the evidence-based framework and is an excellent source to distill clinical questions that still ask for systematic revision or primary studies.
We sincerely hope that the publication of the present guidance document (6) will stimulate extensive discussion and promote commentaries and debate, with the ultimate ambition of improving the appropriate use of TMs but also optimizing the proposed model of comparative summary of the available evidence to facilitate extensive dissemination and consultation of the guidance provided.