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Josh Killilea Chhavi Nashier cn5118@ic.ac.uk ICA 1 : Written Assessment A MedED LECTURESESSION STRUCTURE General StructuStages of WritiCritical ApprFuture ImplicatPersonal Anecdotes BACKGROUND • Given/asked to choose a paper • Depending on BSc Pathway • Set the scene on the paper and the findings • Identify the hypothesis being tested • Summarize results • Are conclusions supported by results? • Comment on limitations: critical analysis • Discuss implications • Identify counterarguments • Discuss robustness CHOOSING A PAPER • Something you are interested in • Methodology that you understand and can critique • Follow the instructions given regarding journals & dates • Narrow down specialties you like • Pick a topic you understand • Talk to reps in the breakout rooms for specific tips STRUCTURE • Introduction paragraph • Stylistic feature (introduction in the form of an LTE) • Identify article and the rationale • Set the opinion from the beginning • Brief summary of the study (methods and findings) • 2-3 appraisal points • Point stated and explained • Counter argument • Counter argument rebuffed • Suggested improvement • Conclusion STRATEGY • Read the methodology of the paper carefully: Do they clearly report their methods? • Points to critique: sample size, recruitment (biases?), outcome measurements?, qualitative studies (number of interviewers and manner of analysis), read the limitations that they have identified • Methods (including statistics) • discussion/conclusions (are they reasonably drawn from the evidence? • Necessity of the article (does it add to existing research, is it clinically relevant?) • Consult CASP checklists • Look at letters published by the journal • Find a paper publishedalready without any letters that have been sent • Offer perspective and relate it to your experience as a medicalstudent • Form an opinion • Consider counterarguments and explore them professionally SETTING THE SCENE • Introduction and Purpose • We read the following article with great interest/We thank X et al for their article on • We would like to comment on the methodology employed and the conclusions drawn • Add a positive comment here • Briefly summarise what they’ve doneCONCLUSION • To conclude, we recommend the use of X… in order to make these results even more applicable to clinical practice/increase external validity Critical Appraisal: The three main aspects 1. Validity • Clear statement of aim • Appropriate methods • Relevantparticipants & selection 2. Trustworthiness of results • Clear reporting of findings • Precision of results • Appropriate data analysis according to pre-specifiedprotocol 3. Value & relevance • Application of findingsbeyond research – appropriateness of conclusions drawn • Were all important outcomes considered? • Location of study and applicabilityoutside area of study Critical Appraisal QR PICO RAMBOS RP FEC 1. QR = question and relevance 2. PICO = summary of the study (population, intervention and controls, outcomes) 3. RAMMBOS = internal validity (Recruitment, allocation, statistical analyses), blinded outcome measure, 4. RP = external validity (resources, populations) 5. FEC= Funding, ethics, conflicts PICO Know what you are appraising • Population – population, patient, problem • Intervention – treatment or exposure for participants • Comparison/Control – placebo, sham, current gold standard • Outcomes – primary and secondary - what is being measured Critical Appraisal QR PICO RAMBOS RP FEC 1. QR = question and relevance 2. PICO = summary of the study (population, intervention and controls, outcomes) 3. RAMMBOS = internal validity (Recruitment, allocation, statistical analyses), blinded outcome measure, 4. RP = external validity (resources, populations) 5. FEC= Funding, ethics, conflicts Critical Appraisal • Recruitment • Consecutive vs non-consecutive • Multicentre vs single centre • Recruitment location can create selection bias (i.e. recruitment from primary vs secondary care) • Consecutive, Multicentre = reduces risk of selection bias Critical Appraisal • Allocation • Randomisation= reduces risk of confounders - Does NOT guarantee • Blinded vs open label = ‘placebo’ effect – think of appropriateness • Block randomisation= recruit 8 patients, randomise to 4 in each arm. Ensures that at all stages of the study, the intervention and control group are almost perfectly balanced • Cluster randomisation= ensures that in multicentre studies, equal numbers of patients from each centre are allocated to each group. Accounts for differences in standard of care, i.e. surgical centresCritical Appraisal Maintenance • Drop out rate – generally <20% adequate to preserve powerbut ideally <10% (=attrition bias) • Treatment outside of the intervention – i.e. same number of visits, same number of tests, same number of educational interactions otherthan study drug Blinded outcome • Blinding: single, double, triple • Single: patient only • Double: patient and physicians interacting • Triple: patient, physicians,outcome extractors • Studies that can’t blind (i.e. surgical) = blinded outcome adjudication Critical Appraisal • Statistics • Power calculation and according recruitment target • Power= likelihoodof detectinga difference when it exists (avoiding Type 2 error) • Statistical models used for outcome measure (binary, continuous, time- dependent) • Effect size and significance level • Absolute risk reduction / Relative risk reduction / NNT • Appropriate conclusions of results Critical Appraisal QR PICO RAMBOS RP FEC 1. QR = question and relevance 2. PICO = summary of the study (population, intervention and controls, outcomes) 3. RAMMBOS = internal validity (Recruitment, allocation, statistical analyses), blinded outcome measure, 4. RP = external validity (resources, populations) 5. FEC= Funding, ethics, conflicts Critical Appraisal • Specialised equipment? Available Resource throughout the world? availability • Cost effectiveness (on patent?) Population • Demographics representativeness • Recruitment • =generalisabilityCritical Appraisal: How does it look in ICA 1 • Large chunk of the essay (500-600 words). • Comment on 2-3 strengths • Comment on 3 main weaknesses (try and come up with your own!!)- try and bring in similar papers which didn’t have the same limitation (do the results differ?) You could include a counterargument at this point • Try and namedrop a bias!Critical Appraisal: Biases Critical Appraisal: CASP • •Randomisation – ↓ selection bias – simple, block, stratified • •Blinding – ↓ detection bias – single, double, triple • •CASP checklist • –PICO – selective reporting bias – inclusion/exclusion criteria • –Intention to treat – Attrition bias • –All other measures consistent between groups? All relevant outcomes considered? • –Treatment effect and precision of resultsCritical Appraisal: CASP https://casp-uk.net/casp- tools-checklists/Future Implications • Try and think about the next steps… • If they are investigating a novel therapeutic agent- which further studies need to be completed to aid its translation? (e.g better animal models?? Human trials??) • Design a study which would address the limitations • What does this research add to the field? How important would future work be?PERSONAL ANECDOTES Stages of WritingTHANKYOU FOR COMING! 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