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      Guidelines for Reporting Case Studies on Extracorporeal Treatments in Poisonings: Methodology

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          Abstract

          A literature review performed by the EXtracorporeal TReatments In Poisoning (EXTRIP) workgroup highlighted deficiencies in the existing literature, especially the reporting of case studies. Although general reporting guidelines exist for case studies, there are none in the specific field of extracorporeal treatments in toxicology. Our goal was to construct and propose a checklist that systematically outlines the minimum essential items to be reported in a case study of poisoned patients undergoing extracorporeal treatments. Through a modified two-round Delphi technique, panelists (mostly chosen from the EXTRIP workgroup) were asked to vote on the pertinence of a set of items to identify those considered minimally essential for reporting complete and accurate case reports. Furthermore, independent raters validated the clarity of each selected items between each round of voting. All case reports containing data on extracorporeal treatments in poisoning published in Medline in 2011 were reviewed during the external validation rounds. Twenty-one panelists (20 from the EXTRIP workgroup and an invited expert on pharmacology reporting guidelines) participated in the modified Delphi technique. This group included journal editors and experts in nephrology, clinical toxicology, critical care medicine, emergency medicine, and clinical pharmacology. Three independent raters participated in the validation rounds. Panelists voted on a total of 144 items in the first round and 137 items in the second round, with response rates of 96.3% and 98.3%, respectively. Twenty case reports were evaluated at each validation round and the independent raters' response rate was 99.6% and 98.8% per validation round. The final checklist consists of 114 items considered essential for case study reporting. This methodology of alternate voting and external validation rounds was useful in developing the first reporting guideline for case studies in the field of extracorporeal treatments in poisoning. We believe that this guideline will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports may provide early signals of effectiveness and/or harm, thereby improving healthcare decision-making.

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          Most cited references14

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          CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials.

          The CONSORT (Consolidated Standards of Reporting Trials) statement is used worldwide to improve the reporting of randomized, controlled trials. Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience.
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            Guidelines for submitting adverse event reports for publication.

            Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide sufficient details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' web sites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events. Copyright 2007 Kelly et al. Reproduced with permission by John Wiley & Sons, Ltd.
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              Case reports describing treatments in the emergency medicine literature: missing and misleading information

              Background Although randomized trials and systematic reviews provide the "best evidence" for guiding medical practice, many emergency medicine journals still publish case reports (CRs). The quality of the reporting in these publications has not been assessed. Objectives In this study we sought to determine the proportion of treatment-related case reports that adequately reported information about the patient, disease, interventions, co-interventions, outcomes and other critical information. Methods We identified CRs published in 4 emergency medicine journals in 2000–2005 and categorized them according to their purpose (disease description, overdose or adverse drug reactioin, diagnostic test or treatment effect). Treatment-related CRs were reviewed for the presence or absence of 11 reporting elements. Results All told, 1,316 CRs were identified; of these, 85 (6.5%; 95CI = 66, 84) were about medical or surgical treatments. Most contained adequate descriptions of the patient (99%; 95CI = 95, 100), the stage and severity of the patient's disease (88%; 95CI = 79, 93), the intervention (80%; 95CI = 70, 87) and the outcomes of treatment (90%; 95CI = 82, 95). Fewer CRs reported the patient's co-morbidities (45%; 95CI = 35, 56), concurrent medications (30%; 95CI = 21, 40) or co-interventions (57%; 95CI = 46, 67) or mentioned any possible treatment side-effects (33%; 95CI = 24, 44). Only 37% (95CI = 19, 38) discussed alternative explanations for favorable outcomes. Generalizability of treatment effects to other patients was mentioned in only 29% (95CI = 20, 39). Just 2 CRs (2.3%; 95CI = 1, 8) reported a 'denominator" (number of patients subjected to the same intervention, whether or not successful. Conclusion Treatment-related CRs in emergency medicine journals often omit critical details about treatments, co-interventions, outcomes, generalizability, causality and denominators. As a result, the information may be misleading to providers, and the clinical applications may be detrimental to patient care.
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                Author and article information

                Journal
                Semin Dial
                Semin Dial
                sdi
                Seminars in Dialysis
                Wiley Periodicals, Inc (Oxford, UK )
                0894-0959
                1525-139X
                July 2014
                29 May 2014
                : 27
                : 4
                : 407-414
                Affiliations
                [* ]Department of Medical Biology, Hôpital du Sacré-Coeur de Montréal, University of Montreal Montreal, Quebec, Canada
                []Division of Nephrology, Hôpital Maisonneuve-Rosemont, University of Montreal Montreal, Quebec, Canada
                []Division of Nephrology, Hôpital du Sacré-Coeur de Montréal, University of Montreal Montreal, Quebec, Canada
                [§ ]Getulio Vargas University Hospital, Federal University of Amazonas Manaus, Amazonas, Brazil
                []Department of Nephrology and Hypertension, Hannover Medical School Hannover, Germany
                [** ]School of Medicine, University of Queensland Brisbane, Queensland, Australia
                [†† ]Department of Renal Medicine, Addenbrooke's Hospital Cambridge, UK
                [‡‡ ]The Ottawa Hospital Research Institute, The Ottawa Hospital Ottawa, Ontario, Canada
                [§§ ]Indiana University Health, Indiana Poison Center Indianapolis, Indiana
                [¶¶ ]Division of Medical Toxicology, Department of Emergency Medicine, Morristown Medical Center Morristown, New Jersey
                [*** ]Division of Medical Toxicology, Department of Emergency Medicine, New York University School of Medicine New York City, New York
                [††† ]Department of Emergency Medicine, Medical Toxicology Service, McGill University Health Centre, McGill University Montreal, Quebec, Canada
                [‡‡‡ ]Department of Pharmacy and Therapeutics, Center for Clinical Pharmaceutical Sciences, University of Pittsburgh School of Pharmacy Pittsburgh, Pennsylvania
                [§§§ ]Nephrology, NYU Langone Medical Center, NYU School of Medicine New York City, New York
                [¶¶¶ ]Division of Nephrology, University of Sao Paulo Medical School Sao Paulo, Brazil
                [**** ]Guy's and St Thomas' NHS Foundation Trust London, United Kingdom
                [†††† ]Division of Nephrology, Indiana University School of Medicine Indianapolis, Indiana
                [‡‡‡‡ ]Danish Poisons Information Centre, Anaesthesiology Bispebjerg University Hospital Copenhagen, Denmark
                [§§§§ ]University of Colorado School of Pharmacy, Clinical Pharmacy Aurora, Colorado
                [¶¶¶¶ ]Hôpital Lariboisière, Réanimation Médicale et Toxicologique, INSERM U1144, Université Paris-Diderot Paris, France
                [***** ]Department of Pharmacy Practice, College of Pharmacy, Purdue University West Lafayette/Indianapolis, Indiana
                [††††† ]Emergency Department and Clinical Toxicology Unit, Hospital Universitari Son Espases Mallorca, Spain
                [‡‡‡‡‡ ]Greater Glasgow & Clyde, Renal Services Glasgow, United Kingdom
                [§§§§§ ]The University of Rochester Medical Center and Strong Memorial Hospital Rochester, New York
                [¶¶¶¶¶ ]Department of Nephrology, Verdun Hospital, University of Montreal Verdun, Quebec, Canada
                Author notes
                Address correspondence to: Valery Lavergne, Hôpital du Sacré-Coeur de Montréal, 5400 Boulevard Gouin Ouest, Montréal, Quebec H4J 1C5, Canada, Tel.: 514-338-2222, or e-mail: valerylavergne@ 123456gmail.com .
                Article
                10.1111/sdi.12251
                4282789
                24890576
                b5adeb36-cb48-445a-9342-b947b55bb09b
                © 2014 The Authors. Seminars in Dialysis Published by Wiley Periodicals, Inc.

                This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                History
                Categories
                Blood Purification in Poisoning

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