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Paeds Vivasprofessional-practice-and-evidence

Paeds Vivas · professional-practice-and-evidence

Paediatric study design and bias — branching viva

Viva on choosing study designs and assessing bias in paediatric research.

branching clinical structured oral4 min readVerification in progress

Target exams

RACP DCEMRCPCH ClinicalRCPSC Pediatrics
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Study tools

Target exams

RACP DCEMRCPCH ClinicalRCPSC Pediatrics
Prompt
Journal club: you are given a randomised controlled trial of a paediatric therapy reporting a large benefit with vaguely described allocation, alongside a case-control study of a rare adverse drug reaction, and a meta-analysis pooling trials across disparate age bands.

Opening (candidate)

I would approach these three papers by first framing the question each addresses, then naming the design that fits it, and finally assessing the risk of bias with the matched tool. For the trial I would check the randomisation process and allocation concealment before trusting the large benefit, because a big effect from a poorly concealed trial is the signature of bias. For the case-control study I would weigh the appropriateness of the design for a rare outcome against the threat of recall bias and confounding. For the meta-analysis I would read the heterogeneity and the forest plot to judge whether the pooling across age bands is defensible. [2] [5]

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You have read the opening of this viva. The complete unit — every section and its primary-source references — is part of the Paediatrics Fellowship fellowship library.

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References7ShowHide
  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]Grimes DA, Schulz KF An overview of clinical research: the lay of the land Lancet, 2002.PMID 11809203
  3. [3]Schulz KF, Grimes DA Case-control studies: research in reverse Lancet, 2002.PMID 11844534
  4. [4]Grimes DA, Schulz KF Bias and causal associations in observational research Lancet, 2002.PMID 11812579
  5. [5]Schulz KF, Chalmers I, Hayes RJ, Altman DG Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials JAMA, 1995.PMID 7823387
  6. [6]Vandenbroucke JP Observational research, randomised trials, and two views of medical science PLoS Med, 2008.PMID 18336067
  7. [7]Sterne JAC, Savović J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials BMJ, 2019.PMID 31462531
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