Evidence-Based Case Reports Methods of design and reporting Indah S. Widyahening with team from the Julius Center for Health Sciences & Primary Care, University Medical Center Utrecht

Evidence-based case reports show how evidence can be applied at all stages of patient care. define the clinical question in four parts: Patient, Intervention, Comparison, Outcome (PICO) show that you have searched for, cited, and summarised studies of appropriate relevance, design, and quality, and should state which bibliographic databases you have used. answer the research question or state that there is no answer available. www.bmj.com

Evidence-based case reports A brief methods section explaining where you found the information. Max 1200 words (provide word count!). Max 24 references. Max 4 illustrations (clinical photographs, imaging, line drawings, figures, tables) A summary box with up to five short single sentences highlighting new or particularly interesting things www.bmj.com

Contents of EBCR Clinical Case clinical scenario / case Question clinical question (PICO) Methods -search strategy/selection (fig1: flow chart) -critical appraisal sorting (Table) Results evaluation selected articles (Table?) Discussion strong and weak points articles Conclusion answer question about patient!

Case Detailed description Motivation problem relevant characteristics findings & particularities Motivation problem knowledge gap (education, study book, practice) Why important?

Clinical question Translation ‘clinical bottom-line’, follows from description of problem. Domain (patient) Determinant (intervention, comparison) Outcome (outcome)

EBM clinical question What is it? -critical question related to an acute + realistic problem concerning patient management for which a knowledge gap exists -specific, answerable What is the aim? Obtain clarity & certainty about the best patient management

Search; methods Methods search -see references and practical lecture -Make it transparent! -Table 1 with search strategy

Search; results Table 1: search strategy Source files searched (internet) Combination of search terms (OR, AND) Numbers Table 1: Search strategy Database Search strategy hits Selection articles Pubmed ((“magnetic resonance imaging” [MeSH]) AND (mammography) AND (“breast neoplasms”[MeSH])) AND (specificity[Title/Abstract]) Limits 57 6 Embase (breast cancer) AND (MR) AND (premenopausal) 2 1 Cochrane Breast neoplasms AND Magnetic Resonance Imaging 19

Select; methods Reduction number titles Prior definition of exclusion and inclusion criteria - study type (design) - domain, determinant, outcome Screening title/abstract With doubt: screening full text

Select; results Figure 1: flow chart selection (flow chart) Search results different databases (number) Clear exclusion criteria Numbers not selected (per exclusion criterium)  Number articles, selected for further assessment (critical appraisal).

Flow chart PubMed Cerebrospinal fluid Embase Screening title abstract* Filtering doubles 79 51 18 13 Exclusion criteria: -Animals -Neonates -Adults -Therapeutic study -CSF composition not specified Children with pneumococcal meningitis Mortality AND Full text availability Useful: 10 articles Excluded because or: -Insufficient outcome (mortality) -Experimental, non-comparable CSF measurement Reading full text* Inclusion criteria: -Prognostic study -Mortality as outcome -CSF composition as prognostic factor 27 1 article found by screening references Not useful (domain: adults also included) Search date: 30 November 2005 *All decisions were made by consensus or at least 2 authors

Critical Appraisal; Methods Relevance for patient (patient included?) Domain, Determinant, Outcome Search similarities & differences Validity study (well performed?) Selection/selection bias Information bias Confounding order

Critical Appraisal; Results In table Criteria relevance Criteria validity Specific for patient’s case Own simply applied system Never forget legends Similarity determinant Similarity domain Similarity outcome

Each question has own design Diagnosis Prognosis Therapy Etiology Prediction Presence/absence disease Course of disease Result of treatment Relation of a risk (etiology) factor Domain (Patient) Patient suspected of disease Patient with diagnosis and probability endpoint Population at risk Determinant (Indicator/Comparator) As in practice Manipulated As in practice (exposure/risk factors) Outcome reference test or -criterium Mortality, morbidity, QoL Mortality, morbidity, QoL Type of study Cross sectional Follow up (time until outcome) Follow up, case-control Design study Descriptive Causal Outcome measure AR RR/RD RR

Strength of evidence; results Summarizing table ‘Best available evidence’ Consideration of quality (relevance and validity) and amount information/studies  best available evidence Results and precision Consistency - discrepancy result

Discussion Interpretation of results on best available evidence Formulation of recommendation for patient Explicit motivation on recommendation Considerations concerning relevance (restrictions?) validity (restrictions?)

EBCR- summary Text Case Research question Search strategy Flow chart introduction case & research question justification management problem Flow chart sources, selection, numbers Tables Relevance & validity Results and strength of evidence interpretation results recommendation management comments Case Research question Search strategy Results & selection criteria Discussion

Evidence based case reports Author requirements see www.bmj.com Click at www.bmj.com under resources for authors, types of articles, practice, Evidence based case reports 

Evaluation form Reviewer: Title: Type Does clinical question pertain to treatment effect? Yes / no Does clinical question pertain to the added value of a determinant or test? Yes / no Does domain involve patients with a confirmed disease? Yes / no Does determinant involve treatment? Yes / no Does outcome involve follow-up? Yes / no

Case-Clinical scenario (case description): insufficient / doubtful / sufficient / good / excellent Question Domain: Determinant: Outcome: Relevance:

Methods Search and selection: insufficient / doubtful / sufficient / good / excellent Critical appraisal: insufficient / doubtful / sufficient / good / excellent Data extraction: insufficient / doubtful / sufficient / good / excellent   Results Outcomes: insufficient / doubtful / sufficient / good / excellent

Conclusion: insufficient / doubtful / sufficient / good / excellent Recommendation:

Tops 1 2 3 Tips Overall rating of report: insufficient / doubtful / sufficient / good / excellent

Weekly target Week 1 presentation: Case illustration. Clinical question and PICO. Existing knowledge on the problem (comparison from several books/sources).

Weekly target Week 2 presentation: (revised) PICO Description on literature search strategy Description about articles found during the search, report on their relevance and validity after critical appraisal (for sub-group with problem on therapy), presented in a table.

Weekly target Week 3 presentation: Description about articles found during the search, report on their relevance and validity after critical appraisal (presented in a table).

Weekly target Week 4 presentation: Complete EBCR with the following structure: Case illustration Clinical question and PICO Methods : literature search (flowchart) and critical appraisal (table) Result as stated in the selected articles Discussion: strengths and weaknesses of the selected evidences Conclusion & recommendation for patient

Questions ?

PLAGIARISME Plagiarisme adalah tindakan seseorang yang mencuri ide atau pikiran yang telah dituangkan dalam bentuk tertulis dan/atau tulisan orang lain dan yang digunakannya dalam tulisannya seolah-olah ide atau tulisan orang lain tersebut adalah ide, pikiran dan/atau tulisan sendiri sehingga merugikan orang lain baik material maupun non material, dapat berupa pencurian sebuah kata, frasa, kalimat, paragraf, atau bahkan pencurian bab dari tulisan atau buku seseorang, tanpa menyebut sumbernya, termasuk dalam Plagiarisme adalah Plagiarisme diri SK Rektor UI no 208 tahun 2009

ALUR SK Rektor UI no 208 tahun 2009 DUGAAN PLAGIARISME LAPORAN TERTULIS PIMPINAN UNIVERSITAS P3T2: PANITIA PENYELESAIAN PELANGGARAN TATA TERTIB KEHIDUPAN KAMPUS UNIVERSITAS INDONESIA TIDAK TERBUKTI TERBUKTI: SK REKTOR SK Rektor UI no 208 tahun 2009

PENCEGAHAN PLAGIARISME Pernyataan bebas plagiarisme pada halaman kedua setelah judul Tugas kuliah/Makalah/Karya ilmiah/Laporan/Penelitian/Skripsi/Tesis/Disertasi SK Rektor UI no 208 tahun 2009