DOI 10.1515/cclm-2013-1045      Clin Chem Lab Med 2014; 52(8): e155–e157

Letter to the Editor Julien Wils, Michèle Fonfrède, Christine Augereau and Joseph Watine*

Further comments on “Critical review of laboratory investigations in clinical practice guidelines: proposals for the description of investigation” Keywords: guideline; laboratory personnel; quality improvement. *Corresponding author: Dr. Joseph Watine, Hôpital de la Chartreuse, Avenue Caylet, 12200 Villefranche-de-Rouergue, France, Phone: +33 5 65 653181, Fax: +33 5 65 653112, E-mail: [email protected] Julien Wils: Laboratoire de Biochimie Médicale, Centre Hospitalier Universitaire, Rouen, France; and Working Group on Guidelines of the Société Française de Biologie Clinique (SFBC), Faculté de pharmacie, Paris, France Michèle Fonfrède: Laboratoire de Biochimie Métabolique, Hôpital de la Pitié-Salpetrière, Paris, France; and Working Group on Guidelines of the Société Française de Biologie Clinique (SFBC), Faculté de pharmacie, Paris, France Christine Augereau: Laboratoire de Biochimie Médicale, Hôpital Européen Georges Pompidou, Paris, France; and Working Group on Guidelines of the Société Française de Biologie Clinique (SFBC), Faculté de pharmacie, Paris, France Joseph Watine: Laboratoire de Biologie Polyvalente, Hôpital Général, Villefranche-de-Rouergue, France; and Working Group on Guidelines of the Société Française de Biologie Clinique (SFBC), Faculté de pharmacie, Paris, France

To the Editor, In a recent article published in Clinical Chemistry and Laboratory Medicine, the Working Group on Guidelines of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) recommends the use of a “comprehensive checklist including 80 topics that should be considered for all laboratory tests included in a clinical practice guidelines” (CPG) [1]. The authors of this article acknowledge that their checklist may be subject to debate, and that feedback and discussion is welcome for future revisions of their checklist. The purpose of this Letter to the Editor is therefore for us, the Working Group on Guidelines of the Société Française de Biologie Clinique (SFBC), to offer that kind of feedback, with particular emphasis on two main points.

First, as this checklist was constructed based on 12 CPG, it sounds reasonable to assume that an even more “comprehensive” checklist could be constructed based on a wider set of CPG. In order to check this hypothesis we tested the 80 topics of the checklist on a sample of four CPG that were endorsed within the last 10  years by the SFBC [2–6]. These four CPG were selected by the first and last co-authors of this Letter to the Editor. In order to be selected by us the CPG should clearly cover the three major domains covered by the EFLM checklists, i.e., the pre-analytical, the analytical, and the post-analytical domains. In this Letter to the Editor we briefly report on the important topics that, when the EFLM checklist was tested on these four CPG, were either missing from the EFLM checklist or that could in our view be reformulated for more clarity. Second, given the fact that CPG are often several hundred pages long, and some items seemingly relevant for the laboratory often do not have a clear impact on clinical decisions, let alone on patient outcomes, we emphasise in this Letter to the Editor essential items that could be considered for inclusion in priority. This is why we also tried to identify items in the EFLM checklist that could be considered less useful. While doing this work we also had in mind the Appraisal of Guidelines for Research and Evaluation (AGREE) checklist [7, 8], even if we understand that the aim of the EFLM checklist is different from that of the AGREE checklist: the former refers to items relevant for the content of CPG, while the latter is a checklist that has been designed to assess CPG methodology. We also kept in mind that, according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group [9] as well as to other prominent members of the EBM movement, four main categories of evidence should be looked for, and examined, when developing CPG, i.e., evidence for clinical benefits, and for clinical harm of recommended interventions, evidence about patients’ views and preference, and evidence regarding

Brought to you by | Karolinska Institute Authenticated Download Date | 5/25/15 4:07 AM

e156      Wils et al.: Evidence-based guidelines in laboratory medicine the impact of recommended interventions on resource utilisation [9, 10]. Examples of topics that are missing, or that could be reformulated: 1. “In the EFLM checklist, the “Negative outcome of testing” and “Positive outcome of testing” items are similar to, although less specific than a similar item of the AGREE checklist, i.e., “Were the health benefits, side effects, and risks considered in formulating the recommendations?” [7]. This also resonates with two of the main categories of evidence advocated by GRADE, i.e., clinical benefits and harms [9]. We therefore suggest that these two items of the EFLM checklist are merged and reformulated more specifically in “Balance between clinical harms and clinical benefits”. It may also be worth mentioning that in the EFLM paper these two items of “negative and positive outcomes of testing” are listed under clinical performance, but according to agreed evidence-based terminology, the relation of testing to outcomes falls under the umbrella term of clinical effectiveness and not clinical performance (which refers to diagnostic, or prognostic, etc accuracy of a test). 2. Two other major values advocated by both AGREE and GRADE relate to resource utilisation, and to patients’ preferences [11, 12]. No topic in the EFLM checklist refers to these important values. We therefore suggest adding two items such as “impact on resources” and “patients’, or relatives’, information and formal consent regarding the implications of the test”. For example, information and consent of the patients, or relatives, are required before testing according to haemochromatosis guidelines [5], or according to the sweat tests guidelines [6]. 3. A topic “repetition of the test” could also be useful. For example, according to the sweat-test guidelines, tests with results in the grey zone need to be repeated [6]. 4. Apart from “age” and “gender”, “weight”, or BMI, should be part of the EFLM checklist. For example, weight is one of the topics included in the sweat-test guidelines [6], or in the toxicology guidelines [2, 4]. 5. “Contraindication” of testing is also missing. For example, sweat tests should not be performed in patients under corticosteroid therapy [6]. 6. There is no clear demarcation in this checklist of the purpose and role of testing and how the test is positioned in a clinical pathway leading to medical decisions and actions [10]. The EFLM Working Group on guidelines could have more clearly explained that the purpose (i.e., screening, diagnosis, risk

stratification, monitoring, prognosis, etc.) and role of the recommended test (i.e., triage, add-on, replacement of old test or test panels) has to be defined in a well-defined clinical pathway, and that the position of a test in a certain testing strategy needs to be clearly specified. For example, diagnostic pathways referring to “triage testing”, “first-line testing”, “second-line testing” and “third-line testing” are not part of the EFLM checklist. This was a problem for us when, for example, we tested the CPG on haemochromatosis where transferrin coefficient of saturation is the first-line test (or triage test), genetic mutation p.Cys282Tyr is the second-line test, and tests for non-HFE mutations are third-line tests [5]. Likewise diagnostic strategies using “clinical score(s)” or at least “score(s) that combine clinical information with laboratory test(s)” are missing from the checklist. For example according to the cardiac markers guidelines, thrombolysis in myocardial infarction (TIMI) is a score that combines troponin and clinical data to evaluate a risk of death [3]. 7. “Risk stratification” also seems to be missing from the EFLM checklist. 8. “Preparation of the patient” and “preparation of the site of sampling” are also missing, and could be added to the pre-analytical subheadings of the checklist. For example, stimulation for sweat tests [6], or the fact that ethanol cannot be used as a skin-disinfectant when it comes to measure ethanol in the blood [2, 4]. Likewise Cl-containing disinfectants cannot be used before sweat testing. 9. There is also no mention, in the post-analytical domain, of “Critical values that should lead to communication of results immediately to the clinician”. We acknowledge that this item could be optional as most critical thresholds are supposed to be based on a consultation and agreement of the laboratory with their clinical users. However, some CPG are also supposed to provide that kind of advice. For example, according to the CPG that we examined, high levels of digoxin in blood [2, 4] or high levels of troponins in blood [3] need to be communicated without delay. Examples of topics that could be considered as less useful: –– Two items listed one after the other in the EFLM checklist as biological interferences “Acute illness” and “Acute phase” are possible duplicates. –– Let us note that in the EFLM checklist the cited analytical or biological interferences are appropriate for many conventional clinical chemistry tests, but

Brought to you by | Karolinska Institute Authenticated Download Date | 5/25/15 4:07 AM

Wils et al.: Evidence-based guidelines in laboratory medicine      e157

many of them are pointless for molecular tests. For example, none of the analytical items, and only a few of the biological items have an influence when it comes to diagnose haemochromatosis with genetic mutation tests [5]. Our Letter to the Editor intends to support the update of the EFLM checklist. First in order to construct a truly comprehensive checklist, tens, if not hundreds, of additional CPGs should be tested. Second, based on such a comprehensive checklist, a shorter checklist grouping items under few key umbrella terms would then suffice for the clinical users or guideline development groups. Further addition of any laboratory-related information from the comprehensive checklist in CPG should be driven by thoughtful consideration of the potential impact of such information within a complex clinical pathway on medical decisions and patient outcomes. This can only be achieved if CPG are evidence-based, and developed using formal consensus methods involving all relevant stakeholders. Since the EFLM checklist was developed solely

by laboratory professionals, it is advised that similarly to the AGREE methodology, the authors widely consult and pilot test their checklist in collaboration with clinical guideline development groups. Such an approach could enhance the validity and acceptability of the EFLM checklist and will have a higher chance of being widely adopted by various clinical guideline organisations and by the biomedical community. Conflict of interest statement Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article. Research funding: None declared. Employment or leadership: None declared. Honorarium: None declared. Received December 4, 2013; accepted February 12, 2014; previously published online March 6, 2014

References 1. Aakre KM, Langlois MR, Watine J, Barth JH, Baum H, Collinson P, et al. Critical review of laboratory investigations in clinical practice guidelines: proposals for the description of investigation. Clin Chem Lab Med 2013;51:1217–26. 2. Bartoli M, Berny C, Danel V, Delahaye A, Desch G, Guitton J, et al; Groupe de travail pluridisciplinaire SFBC-SFTA-STC-SRLF-SFMUCNBH “Toxicologie et biologie clinique”. Recommandations pour la prescription, la réalisation et l’interprétation des examens de biologie médicale dans le cadre des intoxications graves. Ann Biol Clin 2012;70:431–50. 3. Capolaghi B, Charbonnier B, Dumontet M, Hennache B, Henninot J, Laperche T, et al; Groupe de Travail mixte SFBC-CNBH “Troponines”. Recommandations sur la prescription, le dosage et l’interprétation des troponines cardiaques. Ann Biol Clin (Paris) 2005;63:245–61. Erratum in: Ann Biol Clin 2005;63:437. 4. Goullé JP, Lhermitte M, Bartholi M, Boyer JC, Capolaghi B, Charlier C, et al; Groupe de travail pluridisciplinaire SFBC-SFTASTC “Toxicologie et biologie clinique”. Biomarqueurs de toxicité et anomalies métaboliques dans les principales intoxications graves. Symptomatologie clinique et toxique. Le prélèvement conservatoire. Ann Biol Clin 2003;61:421–33. 5. Jouanolle AM, Gérolami V, Ged C, Grandchamp B, Le Gac G, Pissard S, et al. Recommandations pour la (bonne) pratique du diagnostic moléculaire de l’hémochromatose liée au gène HFE. Ann Biol Clin 2012;70:305–13. 6. Rota M, Nguyen-Khoa T, Marchand M, Feldmann D, Dumont J, Khalfon D, et al; Groupe de travail Test de la sueur du Collège national de biochimie des hôpitaux. Recommandations pour

l’exécution et l’interprétation du test de la sueur. Ann Biol Clin 2008;66:221–7. 7. Brouwers M, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, et al, for the AGREE Next Steps Consortium. AGREE II: Advancing guideline development, reporting and evaluation in healthcare. Can Med Assoc J 2010;2010;182:E839–842; Available from: http://www.agreetrust.org/resource-centre/ the-original-agree-instrument/. Accessed 12 January, 2014. 8. Alonso-Coello P, Irfan A, Solà I, Gich I, Delgado-Noguera M, Rigau D, et al. The quality of clinical practice guidelines over the last two decades: a systematic review of guideline appraisal studies. Qual Saf Health Care 2010;19:e58. 9. Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, AlonsoCoello P, et al, GRADE Working Group. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. Br Med J 2008;336:924–6. Available from: http://www.gradeworkinggroup.org/. Accessed 12 January, 2014. 10. Guyatt GH, Oxman AD, Kunz R, Atkins D, Brozek J, Vist G, et al. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol 2011;64:395–400. 11. Watine J, Wils J, Augereau C. Clinical Practice Guidelines: potential misconceptions of the GRADE approach. J Clin Epidemiol 2014;67:7–9. 12. Kunz R, Schunemann HG, Guyatt G. Perceived disagreement (mostly) not confirmed by evidence… A reply to Watine et al.: Clinical practice guidelines: myths and misconceptions. J Clin Epidemiol 2014:67;10–4.

Brought to you by | Karolinska Institute Authenticated Download Date | 5/25/15 4:07 AM

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

Further comments on "Critical review of laboratory investigations in clinical practice guidelines: proposals for the description of investigation". - PDF Download Free
322KB Sizes 4 Downloads 3 Views