Editor-in-chief
Maria Stella Graziani

Deputy Director
Martina Zaninotto

Associate Editors
Ferruccio Ceriotti
Davide Giavarina
Bruna Lo Sasso
Giampaolo Merlini
Martina Montagnana
Andrea Mosca
Paola Pezzati
Rossella Tomaiuolo
Matteo Vidali

International Advisory Board Khosrow Adeli Canada
Sergio Bernardini Italy
Marcello Ciaccio Italy
Eleftherios Diamandis Canada
Philippe Gillery France
Kjell Grankvist Sweden
Hans Jacobs The Netherlands
Eric Kilpatrick UK
Magdalena Krintus Poland
Giuseppe Lippi Italy
☩Howard Morris Australia
Mario Plebani Italy
Sverre Sandberg Norway
Ana-Maria Simundic Croatia
☩Jill Tate Australia
Tommaso Trenti Italy
Cas Weykamp The Netherlands
Maria Willrich USA
Paul Yip Canada


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Responsible Editor
Giuseppe Agosta

Editorial Secretary
Arianna Lucini Paioni
Biomedia srl
Via L. Temolo 4, 20126 Milano
Tel. 0245498282
email: biochimica.clinica@sibioc.it



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BC: Articoli scritti da P. Pezzati

Il Grading of Recommendations Assessment Development and Evaluation(GRADE) quale metodologia sistematica e trasparente per valutare l’esame di laboratorio nella formulazione di raccomandazioni e linee guida
The Grading of Recommendations Assessment Development and Evaluation (GRADE) methodology assystematic and transparent framework to evaluate diagnostic test value in supporting guide lines andrecommendations issuing.
<p>A multidimensional pathway based on GRADE Evidence to Decision (EtD) frameworkis presented. The aim of the document is to define a valid process to assess the adoption of a diagnostic test and theconsequences of the decision. The framework includes three sections reflecting the main steps of GRADE EtD:formulating the relevant question, making an assessment of the evidence, and drawing conclusions. As a matter ofexample, the EtD framework is used to present the evidence concerning the molecular diagnosis of sepsis inneonates including seven dimensions: (1) formulating the question; (2) assessment of diagnostic test accuracy; (3)certainty of the evidence; (4) effects of test on the main patient outcome; (5) balance between the desirable andundesirable effects; (6) resource use; (7) equity, acceptability and feasibility. The example is used to better elucidatethe concepts and to show how reviewers may complete each dimension with the relevant information avaiable.Several factors could influence the final decisions: the relevance of the problem, the values of diagnostic accuracy,the effects of the test on main patient outcome; other issues may play a role. The framework consists of acomprehensive decision aid model to ensure that all important criteria are considered to explain a judgment. Thisapproach could help health professionals to use the best available research evidence in a structured and transparentway to inform decisions in the context of laboratory medicine.</p>
Biochimica Clinica ; 43(1) 076-089
Documenti - Documents
 
I laboratori sono in grado di rispondere ai requisiti previsti dalla norma EN ISO 15189 per la Valutazione Esterna di Qualità? Studio esplorativo sui laboratori toscani per i più comuni misurandi di chimica clinica
A scooping study assessing the compliance of clinical laboratories in Tuscany to ISO /IEC 15189 2012 requirements for clinical chemistry EQAS results
<p>Caro Editore, desideriamo proporre ai lettori di Biochimica Clinica alcuni spunti di riflessione sui requisiti previsti dalla norma EN ISO 15189:2012&nbsp; &ldquo;Medical laboratories-Requirements for quality and competence&rdquo; (1), relativi alla partecipazione a programmi di VEQ come declinati da Accredia, l&#39;ente unico nazionale di accreditamento designato dal governo italiano, con il Regolamento Tecnico (RT) 26 Prescrizioni per l&#39;accreditamento con campo di accreditamento flessibile (2). La norma EN ISO 15189 specifica che, per la concessione o il mantenimento dell&rsquo;accreditamento, i laboratori debbano presentare evidenza di aver conseguito risultati positivi durante la partecipazione agli esercizi VEQ. Il RT 26 richiede che il laboratorio, nel periodo precedente l&rsquo;inoltro della richiesta di accreditamento, abbia ottenuto quattro risultati positivi consecutivi per ogni misurando di cui venga richiesto l&rsquo;accreditamento in campo flessibile. Il documento RT 26 lascia tuttavia, di fatto, spazi per l&rsquo;interpretazione sia al provider che al laboratorio.</p>
Biochimica Clinica ; 42(4) 347-349
Lettere all'editore - Letters to the editor
 
Sicurezza del paziente e rischio clinico nel processo ematologico di laboratorio
Patient safety and clinical risk in the clinical laboratory haematological process
<p>&nbsp;Patient safety, defined as the prevention of harm to patients, is the ultimate goal for medical laboratories. Risk management principles should therefore be considered an integral part of laboratory processes, especially of those activities directly impacting on patient care. This work aims to identify the most critical phases of haematological process and the risk reduction actions that improve patient safety. Risk analysis of the laboratory haematological process was carried out through Failure Mode, Effects and Analysis Criticality methodology. A form including the phases of the process, error modes and their possible effects, errors occurrence, detectability and severity scores and risk index (RI), has been prepared and sent to eight Italian laboratories. A multidisciplinary team performed the analysis in each laboratory, then two team leaders of the project comprehensively analysed the collected data. The process was divided in 8 phases (medical prescription, request acceptance, sample collection, transportation, reception and processing, results reporting and validation), 25 activities (17 pre-analytical, 4 intra-analytical, 4 post-analytical) and 43 failure modes. RI, calculated for each activity, ranged from 11 to 33. The most critical topics (RI &gt;25) were: patient identification, peripheral blood smear review, interpretative comments and report validation. Staff training plays a central role in the entire laboratory haematological process and in the phases identified as critical. An effective management related to the attainment and maintenance of skills represents the best action in order to reduce risks of adverse events for patients. The promotion of procedures aimed to harmonize the interpretative comments and peripheral blood smear review is also pivotal</p><p>&nbsp;</p>
Biochimica Clinica ; 42(4) 300-312
Contributi Scientifici - Scientific Paper
 
Indagine conoscitiva congiunta SIBioC-Medicina di Laboratorio e Associazione Italiana Pneumologi Ospedalieri (AIPO) relativa alla gestione del processo diagnostico del liquido pleurico
Results of a survey produced by the Italian Society of Clinical Biochemestry (SIBioC) and the Italian Association of Hospital Pneumologists (AIPO) concerning pleural fluid analysis
<p>The aim of this paper is to present the preliminary results of a joint project by SIBioC-AIPO working group on &ldquo;Body cavities fluids&rdquo;. The main purpose of the working group is to achieve a harmonized and shared diagnostic pathway related to pleural fluid (PF) analysis. The multistep project begins with a state of the art analysis. A survey, sent to both laboratory medicine personnel and pneumologists, was conducted between October and December 2016. The questionnaire (21 questions) was made available through the web-based SurveyMonkey platform. Overall, 408 replies were collected, 40.4% from laboratory medicine specialists, 3.2% from laboratory technicians, 49.3% from pneumologists and 7.1% from professionals with non-specified qualification. Regarding the pre-analytical phase, the most critical issue resulted to be the clinical query, due to the lack of structured communication between clinicians and laboratory personnel. While over 76% of laboratory professionals stated that the working diagnosis was unavailable, 87% of pneumologists affirmed that the clinical question had been forwarded to the laboratory. An important issue was the widespread use of inappropriate containers for PF collection (60% of inappropriate tubes). Regarding the panel of tests, a satisfactory agreement was reached on the need to perform macroscopic analysis and cytometric evaluation, along with the assessment of pH, glucose, total proteins, lactate dehydrogenase and the respective ratios between PF and serum concentrations. As expected, the availability of verified or validated analytical methods, notably pH analysis, has emerged as a critical point. The layout of the laboratory report also needs improvements and better harmonization. Despite the many critical issues emerged from this survey, a positive feedback was reflected by a notable general interest on PF analysis, leading thus the way to produce a joint consensus document involving clinicians and laboratory personnel, as suggested by more than 30% of responders.</p>
Biochimica Clinica ; 42(2) 119-130
Contributi Scientifici - Scientific papers
 
La gestione del rischio clinico in medicina di laboratorio: risultati del questionario congiunto SIBioC-Medicina di Laboratorio e Società Italiana di Ergonomia (SIE) inviato ai laboratori della Regione Toscana
Misidentification in laboratory medicine: results of the Tuscany survey of the Clinical Risk Management Study Group SIBioC and the Italian Society of Ergonomy (SIE)
<p>In the year 2016 the Study Group on Clinical Risk Management of the SIBioC-Laboratory Medicine Society issued a joint survey with the Italian Society of Ergonomics (SIE); the survey was sent to all the clinical laboratories of the Tuscany Region in Italy. This survey had the aim to understand the level of awareness of the clinical laboratory about the clinical risk management, particularly in the patient misidentification field. The results show a very variable consciousness of the problem among different laboratories, with a very multi-faced approach to this important topic. More than the 93% of the participants state that the errors on misidentification are always registered and in the 80% the consequent actions are tracked.</p>
Biochimica Clinica ; 42(2) 141-145
Contributi Scientifici - Scientific papers
 
Procalcitonina: una palestra metodologica
Procalcitonin: a methodology training ground
Biochimica Clinica ; 42(2) 095-096
Editoriale - Editorial
 
Raccomandazioni per l’identificazione e la gestione dei risultati critici nei laboratori clinici
Recommendations for the detection and management of critical results in clinical laboratories
<p>Critical results, (also known as panic or alarm results) identify a laboratory test result associated with a serious risk for the patient&rsquo;s health, requiring immediate communication to the physician to establish appropriate therapeutic interventions. The adoption of an efficient procedure for the communication of critical values/results is crucial for clinical, ethical, organizational reasons, because it is a requirement for laboratory accreditiation and because of potential legal consequences related to the lack of notification of harmful laboratory results. In 2008, the Italian Society of Clinical Biochemistry and Laboratory Medicine (SIBioC) published its first consensus-based recommendation for the detection and management of critical values in clinical laboratories, with the aim to improve the implementation of standardized and universally accepted procedures, promoting an essential policy toward rational and efficient solutions to this issue. These new recommendations represent a complete review of the first document. Using the same consensus conference method between experts of scientific societies, the main aspects of clinical risk, patient safety and legal liability of health care workers were re-considered. The SIBioC and the Italian Society of Laboratory Medicine (SIPMeL), Intersociety Study Group on Standardization of extra-analytical variability of laboratory results, together with the Italian Society of Ergonomics and Human Factors (SIE) collaboration, issued the present join document.</p>
Biochimica Clinica ; 42(2) 167-179
Documenti SIBioC - SIBioC Documents
 
Le revisioni della letteratura biomedica
The reviews of the biomedical literature
<p>The reviews of the biomedical literature aim to summarize and disseminate the knowledge about a specific topic intended as a disease treatment or a diagnostic biomarker. They include narrative and systematic reviews (SR). Narrative reviews simply describe the features about a specific topic. On the contrary, SR are performed to answer to a specific question by using a standardized methodology to obtain results that may be reproduced by other authors. SR may include studies of diagnostic or therapeutic efficacy and prognostic value according to the scope. SR of treatment efficacy are generally focused on the efficacy of a new treatment in comparison with the one considered as reference, commonly used in the clinical therapeutic protocols. SR focused on diagnostic test accuracy generally retrieve data on diagnostic sensitivity and specificity from original studies in order to estimate pooled likelihood ratios or predictive values. Finally, SR of prognostic studies explore the ability of a specific marker to predict the outcome of interest. A SR implies to plan a systematic literature search strategy by Medline and other biomedical databases, defining inclusion criteria for study selection. Statistical analyses allow to pool data in a meta-analysis to provide an estimates of the effect power. This paper summarize the main features of different type of SR to help readers in the comprension of a SR and meta-analysis. Their utility in clinical practice and biomedical research is also illustrated.</p>
Biochimica Clinica ; 41(2) 175-182
Documenti - Documents
 
Copeptina e patologie cardiocerebrovascolari
Copeptine in cardiocerebrovascular disease
P. Pezzati  |  F. Balboni  | 
<p>Copeptin (CP) is a 39 amino acid glycopeptide including the Cterminal&nbsp;domain of the arginine vasopressine precursor. CP is known to be a stable and sensitive surrogate marker&nbsp;for arginine-vasopressine release and it has been investigated as possible diagnostic and prognostic marker in&nbsp;cardiovascular and cerebrovascular diseases. In particular, the role of CP in the early diagnosis of acute myocardial&nbsp;infarction has been widely investigated and various systematic reviews are currently available. CP associated with&nbsp;cardiac troponin T has been reported to carry a good diagnostic accuracy. These data need, however, to be revised&nbsp;according to the introduction of highly sensitive assays for measuring troponins. Although some evidence on the&nbsp;prognostic value of CP in various cardiovascular frameworks is available, natriuretic peptides maintain a leading role.&nbsp;The research on CP is currently investigating its prognostic value in stroke and transient ischemic attack. However,&nbsp;due to the small sample size of studies and the lack of sound evidence, there are no minimal indications for&nbsp;requesting CP in this framework.</p>
Biochimica Clinica ; 39(3) 168-177
Rassegne - Reviews
 
Procalcitonina e sepsi: alcuni aspetti relativi all’appropriatezza della richiesta
Procalcitonin and sepsis: hints on clinical appropriateness
<p>Sepsis in know to be a challenge for clinicians, given the poor outcome and high costs. Both diagnosis and management are a matter of concern, as appropriate and early therapy can result in higher survival rate. Various biological parameters have been proposed to establish diagnosis<br />and evaluate risk. Procalcitonin (PCT), the precursor of calcitonin, has gained attention as serological marker of sepsis and several authors have claimed for PCT a role in rapid diagnosis as well as risk stratification and prognosis evaluation. Data from systematic reviews support the use of PCT as an alternative to C-reactive protein in adult intensive care unit patients, although its use as sole diagnostic marker does not appear to be appropriate in critical patients. In the emergency department setting PCT can be used to rule out sepsis in adult febrile patients. Data on risk stratification and prognosis are less clear cut and specific clinical questions need further investigation.</p>
Biochimica Clinica ; 37(1) 15-22
Rassegne - Reviews
 
Glossario dei principali termini in uso nell'ambito di ricerche bibliografiche
Glossary of terms used for literature search.
<p><strong>Glossary of terms used for literature search.</strong> The challenge for modern Laboratory Medicine is to find and apply the best available evidence. Electronic access to databases and scientific journals makes information easily retrievable and solves the issue of finding current best evidence. On the other hand, searches may yield a huge amount of data and result in information overload difficult to manage. To be useful, searches should be&#160; made using specific techniques that can be taught and learned. The aim of this glossary is to introduce readers in the world of the literature&#8217;s searches by defining the common use terms. It follows to the glossary, published in 2010 (Biochim Clin 2010;34:212-7), related to the terms used to describe and evaluate clinical trials and papers reporting on the diagnostic performance of laboratory tests.</p>
Biochimica Clinica ; 35(6) 474-480
DOCUMENTI - DOCUMENTI