Efficiency, efficacy and subjective user satisfaction of alternative laboratory report formats. An investigation on behalf of the Working Group for Postanalytical Phase (WG-POST), of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM).

OBJECTIVES: Although laboratory result presentation may lead to information overload and subsequent missed or delayed diagnosis, little has been done in the past to improve this post-analytical issue. We aimed to investigate the efficiency, efficacy and user satisfaction of alternative report formats. METHODS: We redesigned cumulative (sparkline format) and single reports (improved tabular and z-log format) and tested these on 46 physicians, nurses and medical students in comparison to the classical tabular formats, by asking standardized questions on general items on the reports as well as on suspected diagnosis and follow-up treatment or diagnostics. RESULTS: Efficacy remained at a very high level both in the new formats as well as in the classical formats. We found no significant difference in any of the groups. Efficiency improved in all groups when using the sparkline cumulative format and marginally when showing the improved tabular format. When asking medical questions, efficiency and efficacy remained similar between report formats and groups. All alternative reports were subjectively more attractive to the majority of participants. CONCLUSIONS: Showing cumulative reports as a graphical display led to faster detection of general information on the report with the same level of correctness. Considering the familiarity bias of the classical single report formats, the borderline-significant improvement of the alternative tabular format and the non-inferiority of the z-log format, suggests that single reports might benefit from some improvements derived from basic information design.

Presentation and formatting of laboratory results: a narrative review on behalf of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group "postanalytical phase" (WG-POST).

In laboratory medicine, much effort has been put into analytical quality in the past decades, making this medical profession one of the most standardized with the lowest rates of error. However, even the best analytical quality cannot compensate for errors or low quality in the pre or postanalytical phase of the total testing process. Guidelines for data reporting focus solely on defined data elements, which have to be provided alongside the analytical test results. No guidelines on how to format laboratory reports exist. The habit of reporting as much diagnostic data as possible, including supplemental information, may lead to an information overload. Considering the multiple tasks physicians have to do simultaneously, unfiltered data presentation may contribute to patient risk, as important information may be overlooked, or juxtaposition errors may occur. As laboratories should aim to answer clinical questions, rather than providing sole analytical results, optimizing formatting options may help improve the effectiveness and efficiency of medical decision-making. In this narrative review, we focus on the underappreciated topic of laboratory result reporting. We present published literature, focusing on the impact of laboratory result report formatting on medical decisions as well as approaches, potential benefits, and limitations for alternative report formats. We discuss influencing variables such as, for example, the type of patient (e.g. acute versus chronic), the medical specialty of the recipient of the report, the display of reference intervals, the medium or platform on which the laboratory report is presented (printed paper, within electronic health record systems, on handheld devices, etc.), the context in which the report is viewed in, and difficulties in formatting single versus cumulative reports. Evidence on this topic, especially experimental studies, is scarce. When considering the medical impact, it is of utmost importance that laboratories focus not only on the analytical aspects but on the total testing process. The achievement of high analytical quality may be of minor value if essential results get lost in overload or scattering of information by using a non-formatted tabular design. More experimental studies to define guidelines and to standardize effective and efficient reporting are most definitely needed.

Defining laboratory medicine, or squaring the circle?

In the August 2020 issue of Clinical Chemistry and Laboratory Medicine, Giuseppe Lippi and Mario Plebani proposed a definition of laboratory medicine, which ends with this sentence: "The results of these measurements are translated into actionable information for improving the care and/or maintaining the wellness of both a single individual and an entire population". Nevertheless, the selfishness of individuals may, sometimes, jeopardize the interest of whole populations. The virtue of justice being within the reach of the entire human community more than of single individuals, the final sentence in the definition proposed by Giuseppe Lippi and Mario Plebani, should therefore, in our view, be rewritten, less selfishly, for example like this: "For a given investment, these measurements are preferably made when they bring as much beneficence, and non-maleficence, as possible to the whole population".

GRADE equity guidelines 1: considering health equity in GRADE guideline development: introduction and rationale.

OBJECTIVES: This article introduces the rationale and methods for explicitly considering health equity in the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology for development of clinical, public health, and health system guidelines. STUDY DESIGN AND SETTING: We searched for guideline methodology articles, conceptual articles about health equity, and examples of guidelines that considered health equity explicitly. We held three meetings with GRADE Working Group members and invited comments from the GRADE Working Group listserve. RESULTS: We developed three articles on incorporating equity considerations into the overall approach to guideline development, rating certainty, and assembling the evidence base and evidence to decision and/or recommendation. CONCLUSION: Clinical and public health guidelines have a role to play in promoting health equity by explicitly considering equity in the process of guideline development.

GRADE equity guidelines 3: considering health equity in GRADE guideline development: rating the certainty of synthesized evidence.

OBJECTIVES: The aim of this paper is to describe a conceptual framework for how to consider health equity in the Grading Recommendations Assessment and Development Evidence (GRADE) guideline development process. STUDY DESIGN AND SETTING: Consensus-based guidance developed by the GRADE working group members and other methodologists. RESULTS: We developed consensus-based guidance to help address health equity when rating the certainty of synthesized evidence (i.e., quality of evidence). When health inequity is determined to be a concern by stakeholders, we propose five methods for explicitly assessing health equity: (1) include health equity as an outcome; (2) consider patient-important outcomes relevant to health equity; (3) assess differences in the relative effect size of the treatment; (4) assess differences in baseline risk and the differing impacts on absolute effects; and (5) assess indirectness of evidence to disadvantaged populations and/or settings. CONCLUSION: The most important priority for research on health inequity and guidelines is to identify and document examples where health equity has been considered explicitly in guidelines. Although there is a weak scientific evidence base for assessing health equity, this should not discourage the explicit consideration of how guidelines and recommendations affect the most vulnerable members of society.

Evaluation of the methodological quality of two contradictory guidelines recently published by the Haute autorité de santé.

Two clinical practice guidelines published in 2012 and in 2013 by the Haute autorité de santé (HAS) respectively entitled "Adult chronic kidney disease" (clinical pathway guidelines) and "Clinical utility of vitamin D measurements" (Health technology assessment) contradict each other on a notable point: in 2012 the HAS recommend to measure blood concentrations of vitamin D once a year in all patients with chronic kidney disease whereas in 2013 the HAS recommend to use this test only for the ambulatory follow-up of patients three months after kidney transplantation. This contradiction encouraged us to evaluate the methodological quality of these two guidelines with the help of the AGREE (Appraisal of Guidelines for Research and Evaluation) instrument which is consensual at an international level, in particular at the WHO (World Health Organization) and at the European Union. At the end of this comparative evaluation this preliminary hypothesis might be proposed: a more rigorous development (AGREE domain n̊3) as well as a higher editorial independence (AGREE domain n̊6) in 2013 than in 2012 (scores respectively are 57% and 56% in 2013 versus 24% and 25% in 2012) ensure a higher validity to the 2013 recommendations than to the 2012 recommendations. However this hypothesis is weakened by the subjective intrinsic value of the AGREE tool, and by various methodological shortcomings in these two guidelines. Therefore we conclude, using the AGREE terminology, that the methods for developing those guidelines are too uncertain, above all in 2012, for recommending their use without modifications.

Is D-dimer used according to clinical algorithms in the diagnostic work-up of patients with suspicion of venous thromboembolism? A study in six European countries.

INTRODUCTION: Clinical algorithms consisting of pre-test probability estimation and D-dimer testing are recommended in diagnostic work-up for suspected venous thromboembolism (VTE). The aim of this study was to explore how physicians working in emergency departments investigated patients suspected to have VTE. MATERIALS AND METHODS: A questionnaire with two case histories related to the diagnosis of suspected pulmonary embolism (PE) (Case A) and deep venous thrombosis (DVT) (Case B) were sent to physicians in six European countries. The physicians were asked to estimate pre-test probability of VTE, and indicate their clinical actions. RESULTS: In total, 487 physicians were included. Sixty percent assessed pre-test probability of PE to be high in Case A, but 7% would still request only D-dimer and 11% would exclude PE if D-dimer was negative, which could be hazardous. Besides imaging, a D-dimer test was requested by 41%, which is a "waste of resources" (extra costs and efforts, no clinical benefit). For Case B, 92% assessed pre-test probability of DVT to be low. Correctly, only D-dimer was requested by 66% of the physicians, while 26% requested imaging, alone or in addition to D-dimer, which is a "waste of resources". CONCLUSIONS: These results should encourage scientific societies to improve the dissemination and knowledge of the current recommendations for the diagnosis of VTE.

Why are clinical practice guidelines not followed?

Clinical practice guidelines (CPG) are written with the aim of collating the most up to date information into a single document that will aid clinicians in providing the best practice for their patients. There is evidence to suggest that those clinicians who adhere to CPG deliver better outcomes for their patients. Why, therefore, are clinicians so poor at adhering to CPG? The main barriers include awareness, familiarity and agreement with the contents. Secondly, clinicians must feel that they have the skills and are therefore able to deliver on the CPG. Clinicians also need to be able to overcome the inertia of "normal practice" and understand the need for change. Thirdly, the goals of clinicians and patients are not always the same as each other (or the guidelines). Finally, there are a multitude of external barriers including equipment, space, educational materials, time, staff, and financial resource. In view of the considerable energy that has been placed on guidelines, there has been extensive research into their uptake. Laboratory medicine specialists are not immune from these barriers. Most CPG that include laboratory tests do not have sufficient detail for laboratories to provide any added value. However, where appropriate recommendations are made, then it appears that laboratory specialist express the same difficulties in compliance as front-line clinicians.

[Measurements of PSA and of vitamin D: a period of 3-months of use of special forms based on the guidelines of the Haute autorité de santé shows a clear improvement of prescription behaviors]. / Dosages de PSA et de vitamine D : nette amélioration des pratiques professionnelles après 3 mois d'utilisation de formulaires spéciaux fondés sur les recommandations de la HAS.

In France practice guidelines of the Haute Autorité de santé (HAS) are not implemented as often as they should. As a consequence resources are wasted that could be useful elsewhere. In Avril 2014 prescription-forms were introduced in our hospital for PSA and for vitamin-D. If those forms were not filled-in by the physicians, then PSA and vitamin-D were not measured any more by our laboratory. PSA was measured in only two circumstances: therapeutic follow-up of, or screening for, prostate cancer. Patients had to give their formal consent for being screened with PSA. Vitamin-D was measured in the only six circumstances recommended by the HAS. After a few months of use of these two forms we observe a sharp decrease in PSA, and even more so in vitamin D, measurements. Our prescription-forms' legitimacy is high because they are based on governmental guidelines. All the more since the values that are promoted in these guidelines clearly cover the four core principles of bioethics, that is beneficence, non-malevolence, respect for the patient's autonomy (particularly for PSA) and equity. Our results need to be confirmed over a longer period of time, and to be analysed in more detail, particularly regarding the way consent forms are filled-in by the patients.

[Evaluation of the quality of clinical practice guidelines published in the Annales de Biologie Clinique with the help of the EFLM checklist]. / Évaluation de la qualité des recommandations de pratique clinique publiées dans les Annales de biologie clinique à l'aide de la check-list de l'EFLM.

Several tools are available to help evaluate the quality of clinical practice guidelines (CPG). The AGREE instrument (Appraisal of guidelines for research & evaluation) is the most consensual tool but it has been designed to assess CPG methodology only. The European federation of laboratory medicine (EFLM) recently designed a check-list dedicated to laboratory medicine which is supposed to be comprehensive and which therefore makes it possible to evaluate more thoroughly the quality of CPG in laboratory medicine. In the present work we test the comprehensiveness of this check-list on a sample of CPG written in French and published in Annales de biologie clinique (ABC). Thus we show that some work remains to be achieved before a truly comprehensive check-list is designed. We also show that there is some room for improvement for the CPG published in ABC, for example regarding the fact that some of these CPG do not provide any information about allowed durations of transport and of storage of biological samples before analysis, or about standards of minimal analytical performance, or about the sensitivities or the specificities of the recommended tests.

The quality of laboratory aspects of troponin testing in clinical practice guidelines and consensus documents needs to be improved.

OBJECTIVE: The European Federation of Laboratory Medicine (EFLM) and the Union of European Medical Specialists (UEMS) joint Working Group on guidelines recently proposed a checklist to help standardize the description of laboratory investigations in clinical practice guidelines (CPG). METHODS: Nine CPGs or consensus documents published from 2011 to 2013 describing the investigation of chest pain, diagnosis of acute coronary syndrome, or myocardial infarction were evaluated against the published checklist. RESULTS: Clinical use of troponin analysis are commonly dealt with but the publications present variable, vague and sometimes conflicting information regarding this laboratory test being very much relied on upon making a diagnosis of acute coronary syndrome. Most of the laboratory related checklist items are not considered or need to be updated e.g. suggested analytical quality goals are not applicable for the high sensitive assays and important interferences that may lead to false positive or negative diagnoses are commonly not mentioned. CONCLUSION: The current paper sums up important analytical and biological issues related to troponin assays and gives suggestions for analytical quality goals that could be included in CPG's.

Why would medical publishers not incorporate core bioethical values into their Ethics Guidelines?

It is quite universally acknowledged by bioethicists, at least in the western world, that respect for the patients' autonomy, non-malevolence, beneficence, and justice (also called equity) are four core ethical values in medicine. The Ethics Guidelines of key journals in laboratory medicine are not explicit about the first three of these values, and even implicitly, they seem to miss values of justice. Health equity being one of the main objectives of public health policy across the world, we suggest that values of equity explicitly become part of the Ethics Guidelines of laboratory medicine journals. Biochemia Medica could show the way to other medical publishers by incorporating into its Ethics Guidelines these very important core bioethical values.

Clinical practice guidelines: potential misconceptions of the GRADE approach.

OBJECTIVE: To challenge the Grading of Recommendations Assessment, Development and Evaluation (GRADE) group to address the potential misconceptions about their approach to grading the strength of recommendations in clinical practice guidelines. STUDY DESIGN AND SETTING: Based on our own expertise of health care professionals trying to think in depth about, and using, guidelines, we have identified four such misconceptions. RESULTS: These potential misconceptions are: (1) evidence in medicine means factual or scientific evidence; (2) opinions are a subcategory of evidence; (3) the most important evidence is related to clinical benefits and harms; (4) being virtuous, and principled, does not particularly help in developing the best possible guidelines. CONCLUSION: We call on the GRADE leadership to address all the above-mentioned misconceptions. These need explicit answers in their manuscript series.