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Clinical Atlas Prestige · Evidence-first

Psych VivasFoundations — research methods and study design

Psych Vivas · Foundations — research methods and study design

Research methods and study design — structured clinical viva

Fellowship viva on design selection, observational versus experimental threats, reporting standards, and evidence synthesis.

clinical
On this page & tools

Target exams

FRANZCPMRCPsychABPNMD-DNB

Target exams

FRANZCPMRCPsychABPNMD-DNB
Prompt
You are in a FRANZCP/MRCPsych-style viva. The examiner says: 'A pharmaceutical company proposes an open-label, non-randomised comparison of Drug X versus Drug Y for first-episode psychosis, with PANSS change at 8 weeks as the primary outcome, analysed among completers only. Separately, your department wants to know the 12-month prevalence of depression in the local catchment and whether depression is associated with unemployment on a single household survey. Finally, a trainee asks whether a meta-analysis is always required after a systematic search.' Defend how you would design or redesign each programme, name bias threats, and name reporting standards. Be ready for follow-ups on concealment versus blinding, confounding by indication, STROBE versus CONSORT, and Hill criteria.

Interpretation

Reveal interpretation

Drug X vs Y programme. As proposed, this is a non-randomised comparative study, not an RCT. Confounding by indication (sicker patients channelled to one drug), open-label performance/detection bias on PANSS, and completer analysis (attrition) are fatal threats for a causal therapy claim.[1][4][7] Redesign: parallel-group RCT with random sequence, allocation concealment, blinding of outcome assessors at minimum, pre-specified primary outcome, and ITT primary analysis, reported with CONSORT.[2][7][8] If randomisation is truly impossible, label it observational, use ROBINS-I thinking, and avoid causal marketing language.

Catchment depression and unemployment. Single-time household survey is a cross-sectional design: appropriate for prevalence if sampling and response are rigorous; association with unemployment cannot establish direction (unemployment → depression vs depression → job loss).[1][4] Report with STROBE cross-sectional items; do not claim incidence or strong causation without longitudinal data.[3]

Meta-analysis after systematic search. A systematic review can stop at structured narrative synthesis; meta-analysis is optional when studies are sufficiently similar clinically and statistically. PRISMA governs reporting of the review process, not a mandate to pool incompatible trials.[5]

Follow-ups. Concealment ≠ blinding.[8][2] Hill criteria help weigh observational associations (temporality, strength, consistency, etc.) without replacing experimental evidence when RCTs are feasible.[6]

Key points

Name the design honestly

Open-label non-randomised comparisons are not RCTs — say so before discussing effect sizes.

Prevalence ≠ causation

Cross-sectional surveys answer frequency questions; temporality is their Achilles heel.

Pooling is optional

Systematic methods first; meta-analysis only when pooling is defensible.
[1] [2] [5]

References

  1. [1]Grimes DA, Schulz KF An overview of clinical research: the lay of the land Lancet, 2002.PMID 11809203
  2. [2]Schulz KF, Altman DG, Moher D; CONSORT Group CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials BMJ, 2010.PMID 20332509
  3. [3]von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies Lancet, 2007.PMID 18064739
  4. [4]Grimes DA, Schulz KF Bias and causal associations in observational research Lancet, 2002.PMID 11812579
  5. [5]Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews BMJ, 2021.PMID 33782057
  6. [6]Hill AB The environment and disease: association or causation? Proc R Soc Med, 1965.PMID 14283879
  7. [7]Hollis S, Campbell F What is meant by intention to treat analysis? Survey of published randomised controlled trials BMJ, 1999.PMID 10480822
  8. [8]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