Theimportanceofcasereports

,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,The importance of case reports,Dr. Barun Kumar Nayak,Head of Ophthalmology Department,P.D.Hinduja National Hospital and Medical Research Centre,Editor- Indian Journal of Ophthalmology,1,Peer-reviewed medical journals are the means for disseminating new knowledge and Science,Do case reports justify its publication?,2,Some journals publish no case reports whereas there are some journals which publish case reports only,3,Why two extremes?,4,A case report described and discusses an instance of disease in a patient,The essential characteristic of a publishable case report is educational value,Writing case reports is one of the best ways to get started in medical writing. They are little mysteries that hold readers interest and take less time to prepare,5,Value of case reports,It describes important scientific observations that are missed or undetectable in clinical trials,6,Case report linked the,FDA,approved anorexic agents (,fenfluramine,and dexfenfluramine) with primary pulmonary hypertension,Trials evaluating incidence, mechanism, risk factor,Withdrawal of drug from market,7,Case report of kaposis sarcoma in a young homosexual man,Development of AIDS,8,First line of evidence for new therapies,Physostigmine in myasthenia gravis,Potassium iodine in erythema nodosum,TNF ,antibody treatment in psoriasis,Dapsone in Behcet disease,Insulin for type 1 Diabetes mellitus,9,Value of case reports,Rare indications,Difficult to conduct trial with adequate sample and power,Difficult to get funded by pharmaceutical companies,1995 Mycophenolate mofetil was approved in the United States and UK for immunosuppression after renal transplants and 1997 off label use was reported in pyoderma gangraenosum, autoimmune anemia, pemphigus vulgaris, bullous pemphigoid, systemic vasculitis and IgA nephropathy.,10,Thalidomide off label uses,Observational evidence,Brain neoplasm,Crohn,disease (,lenalidomide,failed trial),Discoid lupus,erythematosus,Erosive lichen,planus,Erythema,multiforme,Prevention of graft versus- host disease,Subacute,cutaneous,lupus,erythematosus,11,Randomized controlled clinical trials,Behcet,syndrome,Cachexia,caused by HIV,Graft-versus-host disease,Mycobacteriosis,Prevention of recurrent,aphthous,stomatitis,(negative),Recurrent,aphthous,stomatitis,12,Side effects of drugs described in case reports,Anti TNF antibody -Vitiligo/ Vascentitis,Interferon, - Psoriasis exacerbation,IV immunoglobulin - stroke,13,14,OBSERVATION,DOCUMENTATION,HYPOTHESIS,GENERATION,15,CLINICAL TRIAL,Physiologic,Studies,Observation,Documentation,Hypothesis Generation,Incorporation into,Clinical practice,Interpretation in Clinical Context,CLINICAL TRIAL,CLINICAL TRIAL,16,Value of case reports (contd),103 reports published in Lancet,Followed after 5 yrs,24 reports were followed by Publication of RCT or in the registry of RCT,17,Case reports for authors,Opportunity to Publish (Beginners),Easy to write,Good learning practice,18,Drawbacks of case reports,False alarms can be raised.,Eg. Debendox/ bendectin (combination of pyridoxine and doxylamine succinate) marketed for morning sickness in pregnancy. Based on reports of malformations it was withdrawn from US but still available in Canada without evidence of human teratogenicity,19,Drawbacks,Readability is high and they are Influential,BUT,Less citable (Max- meta analysis and min-case reports),Reduce Impact Factor, hence editors do not like case reports,20,Drawbacks,Publication bias (90%) reporting successes versus 10% reporting failure,Methodology is not robust,Most of the once-popular discarded therapies are based on case reports,CONTD,21,Thalidomide extreme example of primarily off label use. Licensed in 1998 for treatemt and prevention of erythema nodosum leprosum ( extremely rare) and multiple myeloma was added in 2006, but 90% of the physicians who prescribed it was for off- label use,HIV cachexia indication RCT was published 11yrs after approval by FDA,22,Drawbacks,Off- label use drugs are not allowed to be advertised in U.S,Companies promote educational supplements,Promote publications of Case reports,23,Criteria for publishable case reports,Advance medical science and spawn research;,Describe rare,preplexing, or novel diagnostic features of a disease state;,Report therapeutic challenges, controversies, or dilemmas;,Describe a new surgical procedure;,Report how a drug can enhance a surgical procedure,Teach humanistic lessons to the health care professionals;,Review a unique job description of a health care professional that improves patient care;,Report new medical errors or medication errors;,Discover a device malfunction that results in patient harm;,Describe adverse effects and patient toxicity of a,radiopaque,agent;,Describe life-threatening adverse events;,Am J Health-Syst Pharm Vol 63 Oct1,2006,24,Describe dangerous and predictable adverse effects that are poorly appreciated and rarely recognized;,Describe rare or novel adverse drug reactions;,Describe a therapeutic failure or a lack of therapeutic efficacy;,Describe rare or novel drug-drug, or drug-food or drug- nutrient interactions;,Report unlabeled or unapproved uses of a medication,Explore the use of,pharmocogenomics,to manage diseases;,Use life-saving techniques not previously documented;,Use,pharmacoeconomics,principles that improve patient care;,Uncover barriers to patient adherence;,Discover an interaction between a drug and a laboratory test that yields a false-positive or false-negative result;,Describe the effect of drugs in pregnancy and lactation,Detect novel,pharmocokinetic,or,pharmacodynamic,principles; and,Use technology to improve patient outcomes.,Am J Health-Syst Pharm Vol 63 Oct1,2006,25,Guidelines for writing patient case report manuscripts,Abstract,Introduction and objective,Case report,Discussion,Conclusion,Introduction,Describe the subject matter,State the purpose of the case report,Provide background information,Provide pertinent definitions,Describe the strategy of the literature review and provide search terms,Justify the merit of the case report by using the literature review,Introduce the patient case to the reader,Make the introduction brief and less than three paragraphs,Am J Health-Syst Pharm Vol 63 Oct1,2006,26,Patient case presentation,Describe the case in narrative form,Provide patient demographics (age,sex,height, weight, race, occupation),Avoid patient identifiers (date of birth, initials),Describe the patients complaint,List the patients present illness,List the patients medical history,List the patients family history,List the patients social history,List the patients medication history before admission and throughout the case report,Am J Health-Syst Pharm Vol 63 Oct1,2006,27,Ensure that the medication history includes herbals, vaccines, depot injections, and non-prescription medications, and state that the patient was asked for this history.,List each drugs name, strength, dosage form, route, and dates of administration,Verify the patients medication adherence,Provide renal and hepatic organ function data in order to determine the appropriateness of medication dosing regimens,List the patients drug allergy status, including the name of the drug (brand or generic) and the date and type of reaction,Am J Health-Syst Pharm Vol 63 Oct1,2006,28,List the patients adverse drug reaction history and the dates of the reaction,Provide pertinent serum drug levels and include the time of each level taken and its relationship to a dose,Provide the patients dietary history,Provide pertinent findings on physical examination,Provide pertinent laboratory values that support the case.,Provide the reference range for laboratory values that are not widely known or established,List the completed diagnostic procedures that are pertinent and support the case,Paraphrase the salient results of the diagnostic procedures,Provide photographs of histopathology, roentgenograms, electrocardiogram, skin manifestations, or anatomy as they relate to the case,Am J Health-Syst Pharm Vol 63 Oct1,2006,29,Obtain permission from the patient to use the patients photographs, or follow institutional guidelines,Provide the patients events in chronological order,Ensure a temporal relationship,Ensure a causal relationship,Ensure that the patient case presentation provides enough detail for the reader to establish the cases validity,Am J Health-Syst Pharm Vol 63 Oct1,2006,30,Discussion,Compare and contrast the nuances of the case report with the literature review,Explain or justify the similarities and differences between the case report and the literature,List the limitations of the case report and describe their relevance,Confirm the accuracy of the descriptive patient case report,Establish a temporal relationship,Report the validity of the case report by applying a probability scale such as the,Naranjo,nomogram,Summarize the salient features of the case report,Justify the uniqueness of the case,Draw recommendations and conclusions,Am J Health-Syst Pharm Vol 63 Oct1,2006,31,Discussion,Provide a justified conclusion,Provide evidence-based recommendations,Describe how the information learned applies to ones own practice,List opportunities for research,Ensure that this section is brief and does not exceed one paragraph,Am J Health-Syst Pharm Vol 63 Oct1,2006,32,Guidelines for case report writing,Abstract,Introduction,Case presentation,Discussion,Conclusion,33,Check list for Case Reports,Abstract: should,summarise,the whole case,Introduction: rationale adequately explained & substantiated by references,Case Description : brief adequate & clear,Investigations adequate & with normal values for uncommon ones,Discussion : diagnosis and recommendations supported potential issues refuted/ addressed,34,Usual questions which the editors expect reviewer to answer,Introduction,Is the rationale for reporting the case adequately explained?,Is the rationale for reporting the case adequately substantiated by references?,CONTD,35,Description of the case,Is the case described adequately?,Is the case described briefly?,Is the case described clearly?,Are the results of investigations described adequately?,Are the results of less common laboratory investigations accompanied by normal values?,CONTD.,36,Comments,Is the evidence to support the authors diagnosis presented adequately?,Is the evidence to support the authors recommendations presented adequately?,Are other plausible explanations considered and refuted?,Are the implications and relevance considered of the case discussed?,Do the authors indicate directions for future investigations or management of similar cases?,37,Confidentiality,Informed consent,IRB approval,38,Laws / Acts of interest,Health Insurance Portability & Accountability Act.1996 (HIPAA),US Dept of Health & human sciences,Identifiable Personal Information (IPI),Personal Information Protection & Electronic Documents Act (PIPEDA),Canada 2000,39,Protection of Patients anonymity,Name / Initials / Adderss,Hospital No / Unique Identifiers,Dates,Race / Biometrics,Pedigree / Photographs,Disguise identifying information,Patients charactersitics,Personal history,40,When to take Informed Consent?,Before writing manuscript,Pt. may be worried about final report,What if author does not complete report?,After writing manuscript,If pt refuses,May resent refusal,Pt worried about saying “no”,If manuscript rejected,Informed consent in vain,Unnecessary mental trauma for patient,41,Solution !?,Take IC after the case report is accepted for publication,Limitation puts author at risk of patient refusal,42,Written Informed Consent,Eliminates risk of litigation,Protects authors journal & publishers,Fails to protect from future negative personal consequences,43,0-2,0-2,0-2,0-2,0-2,0-10,Interpretation,Education Value,Documentation,Uniqueness,Objectivity,44,Thank you,45,