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.

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.

Critical review of laboratory investigations in clinical practice guidelines: proposals for the description of investigation.

BACKGROUND: Correct information provided by guidelines may reduce laboratory test related errors during the pre-analytical, analytical and post-analytical phase and increase the quality of laboratory results. METHODS: Twelve clinical practice guidelines were reviewed regarding inclusion of important laboratory investigations. Based on the results and the authors' experience, two checklists were developed: one comprehensive list including topics that authors of guidelines may consider and one consisting of minimal standards that should be covered for all laboratory tests recommended in clinical practice guidelines. The number of topics addressed by the guidelines was related to involvement of laboratory medicine specialists in the guideline development process. RESULTS: The comprehensive list suggests 33 pre- analytical, 37 analytical and 10 post-analytical items. The mean percentage of topics dealt with by the guidelines was 33% (median 30%, range 17%-55%) and inclusion of a laboratory medicine specialist in the guideline committee significantly increased the number of topics addressed. Information about patient status, biological and analytical interferences and sample handling were scarce in most guidelines even if the inclusion of a laboratory medicine specialist in the development process seemingly led to increased focus on, e.g., sample type, sample handling and analytical variation. Examples underlining the importance of including laboratory items are given. CONCLUSIONS: Inclusion of laboratory medicine specialist in the guideline development process may increase the focus on important laboratory related items even if this information is usually limited. Two checklists are suggested to help guideline developers to cover all important topics related to laboratory testing.

Reflective testing: adding value to laboratory testing.

Reflective testing is a procedure in which the laboratory specialist adds additional tests and/or comments to an original request, after inspection (reflection) of the results. It can be considered as an extension of the authorization process where laboratory tests are inspected before reporting to the physician. The laboratory specialist will inevitably find inconclusive results, and additional testing can contribute to make the appropriate diagnosis. Several studies have been published on the effects of reflective testing. Some studies focus on the opinion of the general practitioners or other clinicians, whereas other studies were intended to determine the patient's perspective. Overall, reflective testing was judged as a useful way to improve the process of diagnosing (and treating) patients. There is to date scarce high quality scientific evidence of the effectiveness of this procedure in terms of patient management. A randomized clinical trial investigating this aspect is however ongoing. Cost effectiveness of reflective testing still needs to be determined in the future. In conclusion, reflective testing can be seen as a new dimension in the service of the clinical chemistry laboratory to primary health care. Additional research is needed to deliver the scientific proof of the effectiveness of reflective testing for patient management.

[Recurring peritonitis due to Streptococcus from the upper respiratory tract in a saxophone player under peritoneal dialysis]. / Péritonites récidivantes à streptocoques oraux chez un joueur de saxophone en dialyse péritonéale.

This is a nephrectomized patient of 77 years, musician (saxophonist), in peritoneal dialysis, with diabetes, hypertension, and coronary disease. He presented a few months apart two successive episodes of peritonitis due to Streptococcus mitis/oralis and Streptococcus parasanguis. Before each episode he played the saxophone he played twice and each time he has peritonitis. Colonoscopy objectifying a sigmoid polyp. The assumption of self-contamination of the patient was supported by the fact that S. mitis/oralis and S. parasanguis are oral streptococci, and the intraperitoneal pressure (IPP) from 8 to 32 cm of water when the patient plays the saxophone. In this measurement of IPP we have also seen how the saliva is spread on all sides when playing the saxophone. Our patient is now cured and did not include the saxophone.

What sort of bioethical values are the evidence-based medicine and the GRADE approaches willing to deal with?

The concept of evidence-based medicine (EBM) has been invented by physicians mostly from English Canada, mostly from McMaster University, Ontario, Canada. The term EBM first appeared in the biomedical literature in 1991 in an article written by a prominent member of this group-Gordon Guyatt from McMaster University. The inventors of EBM have also created the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) working group, which is a prominent international organisation whose main purpose is to develop evidence-based clinical practice guidelines (CPGs). CPGs that are based on the GRADE approach are becoming increasingly adopted worldwide, in particular by many professional or governmental organisations. This group of thinkers being thus identified, we have retrieved and read many of their publications in order to try and understand how they intend to incorporate bioethical values into their concept. The author of this little essay did also spend a few years on the internet as an active member of the GRADE group discussion list. The observations thus gathered suggest that although some of the inventors of EBM, at least Gordon Guyatt, wish to incorporate core principles of biomedical ethics into their concept (ie, non-malevolence, beneficence and maybe to a lesser extent respect for autonomy, and justice), some clarifications are still necessary in order to better understand how they intend to more explicitly incorporate bioethical values into their concept and, perhaps more importantly, into evidence-based CPGs.

[Evaluation of the AFSSAPS clinical practice guidelines on prevention and treatment of thrombo-embolic disease in medicine (2009), in comparison with those of the American College of Chest Physicians (ACCP 2008) with the help of the AGREE tool]. / Évaluation du référentiel de l'Afssaps sur la prévention et le traitement de la maladie thromboembolique veineuse en médecine (2009) par comparaison à celui de l'American College of Chest Physicians (ACCP 2008) à l'aide de la grille AGREE.

We have evaluated the methodological quality of the AFSSAPS French clinical practice guidelines on prevention and treatment of thrombo-embolic disease in medicine, published in 2009. We have evaluated in parallel the similar recommendations from north-America on the subject (ACCP 2008). Our evaluation tool was the AGREE instrument which is consensual at an international level, in particular at the WHO (World Health Organisation) and at the European Union. The methodological quality of the AFSSAPS guidelines is sub-optimal, significantly lower than that of the ACCP guidelines. Compared with the ACCP guidelines, the weakest points of the AFSSAPS guidelines are about rigor of development (AGREE domain 3), applicability (AGREE domain 5) and editorial independence (AGREE domain 6). The main common shortcoming in quality of both guidelines is about lack of stakeholder involvement (AGREE domain 2). A more important implication of methodologists might explain why the ACCP guidelines reach a higher level of quality than those of the AFSSAPS guidelines. We do not make judgments about the content of the recommendations of the AFSSAPS or of the ACCP.

[Evaluation of the methodological quality of the Rémic (microbiology guidelines - bacteriology and mycology) of the Société française de microbiologie]. / Évaluation de la qualité méthodologique du Rémic (référentiel en microbiologie médicale - bactériologie et mycologie) de la Société française de microbiologie, 3(e) édition (2007).

We have evaluated the methodological quality of the Rémic (microbiology guidelines - bacteriology and mycology) of the Société française de microbiologie (edition2007), using to AGREE criteria, which are consensual at an international level, in particular at the the World Health Organisation (WHO) and at the European Union. The methodological quality of the Rémic appears to be sub-optimal. These shortcomings in quality are mainly observed in AGREE domain n° 5 (applicability), in AGREE item n° 5 (patients' opinions were not considered), and in AGREE item n° 23 (conflicts of interest were not declared). The users of the Rémic must be aware of these few methodological shortcomings in order for them to be careful before they put its recommendation in practice. In conclusion, we advise the editors of the Rémic to insert at least a methodological chapter in their next edition.

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".

Translations of the "Evidence-Based Medicine" concept in different languages: is it time for international standardisation?

Although the concept of Evidence-Based Medicine (EBM) is quite popular among English speaking physicians, it still needs to be adopted by an overwhelming majority of health care professionals in countries where English is not familiar. Thus, this concept can be translated in many different, and potentially misleading, ways. This is regrettable because the concept is, at least potentially, a very useful one. As an illustration, I have compiled some of the French translations of EBM that are currently in use in French speaking countries, and indicated briefly how most of these translations (except for one) are bound to be misleading. Many of these misleading translations currently in use strongly suggest that it is time for an international standardisation of the translations of EBM in different languages.

Do guidelines for the diagnosis and monitoring of diabetes mellitus fulfill the criteria of evidence-based guideline development?

BACKGROUND: Although the methodological quality of therapeutic guidelines (GLs) has been criticized, little is known regarding the quality of GLs that make diagnostic recommendations. Therefore, we assessed the methodological quality of GLs providing diagnostic recommendations for managing diabetes mellitus (DM) and explored several reasons for differences in quality across these GLs. METHODS: After systematic searches of published and electronic resources dated between 1999 and 2007, 26 DM GLs, published in English, were selected and scored for methodological quality using the AGREE Instrument. Subgroup analyses were performed based on the source, scope, length, origin, and date and type of publication of GLs. Using a checklist, we collected laboratory-specific items within GLs thought to be important for interpretation of test results. RESULTS: The 26 diagnostic GLs had significant shortcomings in methodological quality according to the AGREE criteria. GLs from agencies that had clear procedures for GL development, were longer than 50 pages, or were published in electronic databases were of higher quality. Diagnostic GLs contained more preanalytical or analytical information than combined (i.e., diagnostic and therapeutic) recommendations, but the overall quality was not significantly different. The quality of GLs did not show much improvement over the time period investigated. CONCLUSIONS: The methodological shortcomings of diagnostic GLs in DM raise questions regarding the validity of recommendations in these documents that may affect their implementation in practice. Our results suggest the need for standardization of GL terminology and for higher-quality, systematically developed recommendations based on explicit guideline development and reporting standards in laboratory medicine.

Molecular typing indicates an important role for two international clonal complexes in dissemination of VIM-producing Pseudomonas aeruginosa clinical isolates in Hungary.

VIM metallo-beta-lactamase-producing serotype O11 or O12 Pseudomonas aeruginosa isolates infecting or colonising 19 patients from seven hospitals were reported in Hungary between 2003 and 2005. In this study we characterised VIM-producing Pseudomonas spp. clinical isolates from two novel locations in Hungary; we identified three new bla(VIM) carrying integron types and the presence of the bla(VIM-2) allele in Hungary. By applying various typing techniques, including multilocus sequence typing, we revealed an important role of two international clonal complexes, CC4 and CC11, in the dissemination of bla(VIM)-positive P. aeruginosa in hospitals in Hungary. Isolate P12-Q, a representative strain from France of the major European multiresistant P12 clone, displayed ST111 which, according to eBURST analysis, is the presently calculated founder sequence type of CC4. This is in accordance with the wide geographic distribution of the P12 clone. Our data indicate that, although the CC4 clonal complex includes serotype O1 and O6 isolates as well, it also contains the P12 clone. We characterised a P. aeruginosa nosocomial clone with a singleton sequence type (ST313), that may have acquired bla(VIM-2) and bla(VIM-4) gene cassettes from a yet unidentified local gene pool in Hungary.

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.

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.