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Paeds Casesprofessional-practice-and-evidence

Paeds Cases · professional-practice-and-evidence

Appraising a trial for a shared decision — OSCE

OSCE on appraising a randomised trial and applying its evidence to a shared decision with a family.

osce critical appraisal and shared decision
On this page & tools

Target exams

MRCPCH ClinicalRACP DCERCPSC Pediatrics

Target exams

MRCPCH ClinicalRACP DCERCPSC Pediatrics
Prompt
Parents of a 4-year-old with a chronic illness are deciding whether to start a daily preventive therapy; they have read online that it 'reduces the risk of a serious complication by 50%'; you have a randomised trial in adults reporting that figure, a p-value of 0.04, and a confidence interval whose lower bound crosses unity in children.

Station brief (8–10 minutes)

Help the parents decide whether to start the preventive therapy by appraising the trial honestly and applying it to their child. Address the online '50 percent' figure, the trial's validity, the magnitude and precision of the effect, and its applicability to a four-year-old. Do not invent jurisdiction-specific thresholds or specific survival statistics. [1]

Tasks for the candidate

  1. Frame the clinical question in PICO terms and describe how you would judge the trial's validity before its results. [2]
  2. Reframe the '50 percent' figure with the absolute baseline, the absolute risk reduction, and the confidence interval. [1] [5]
  3. Assess the applicability of adult-trial evidence to a four-year-old and rate the certainty with GRADE. [6] [3]
  4. Integrate the evidence with the family's values through shared decision-making, and arrange follow-up. [4] [6]

Expected performance

Must hit. PICO question stated; validity scored with RoB 2 before results, naming randomisation, allocation concealment, blinding, attrition and selective reporting; absolute baseline and absolute risk reduction given alongside the relative figure; confidence interval read for precision and null-crossing; applicability to a four-year-old weighed and certainty rated with GRADE; decision integrated with values; written summary and follow-up arranged. [2] [6]

Merit. Acknowledges the online figure without dismissing the parent; places the single trial in the totality of the evidence; names the indirectness explicitly and downgrades certainty; uses teach-back and a decision aid for the preference-sensitive choice. [3] [4]

Fail. Quotes the 50 percent relative figure alone; reads results before validity; ignores a null-crossing confidence interval; applies adult evidence to a child without weighing applicability; gives no certainty rating, no shared decision, and no follow-up. [5] [6]

Sample candidate structure

“Thank you both for coming in. First, let me be clear about the question we are trying to answer: in a preschool child like yours, does this daily preventive therapy, compared with not taking it, reduce the chance of a serious complication. Before I trust the number you read, I need to check whether the study was fair — was it randomised, were families and assessors blinded, and did everyone stay in the trial. … The '50 percent' you saw is a relative figure, and on its own it looks bigger than it is. Let me show you the absolute numbers: out of 100 children like yours, about this many would have the complication without the medicine, and this many fewer with it. The study was done in adults, and its confidence interval crosses the line of no effect in children, so I would rate the certainty down and be honest that the benefit to a four-year-old is less sure. Let's weigh that together against the side effects and what matters most to your family, and we will check how it goes.” [1] [5] [6]

References

  1. [1]Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS Evidence based medicine: what it is and what it isn't BMJ, 1996.PMID 8555924
  2. [2]Sterne JAC, Savovic J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials BMJ, 2019.PMID 31462531
  3. [3]Balshem H, Helfand M, Schunemann HJ, et al. GRADE guidelines: 3. Rating the quality of evidence J Clin Epidemiol, 2011.PMID 21208779
  4. [4]Andrews J, Guyatt G, Oxman AD, et al. GRADE guidelines: 14. Going from evidence to recommendations: the significance and presentation of recommendations J Clin Epidemiol, 2013.PMID 23312392
  5. [5]Greenhalgh T How to read a paper. Statistics for the non-statistician. II: Significant relations and their pitfalls BMJ, 1997.PMID 9277611
  6. [6]Murad MH, Montori VM, Ioannidis JP, et al. How to read a systematic review and meta-analysis and apply the results to patient care: users' guides to the medical literature JAMA, 2014.PMID 25005654