Specimen Appraisal Trial

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Presentation transcript:

Specimen Appraisal Trial Adrian Boyle

Suturing versus conservative management of lacerations of the hand: randomised controlled trial BMJ

What did they do? PICO Population Intervention Control Outcome(s) Consecutive (11am-11pm) patients with hand lacerations less than 2cm long Excluded: Nail Bed / Diabetics / Deep structure injury / Bites Intervention Conservative management of hand wounds with irrigation and antibiotic cream Control Hand suturing under LA after irrigation and antibiotic cream Outcome(s) Pain (VAS) / Wound Infection / Scar review at 3 months

What did they find? Results . What did they find? Results Treatment Mean difference (95% CI) Clinical outcome Suture Conservative Cosmetic appearance at 3 months (mm)*: Assigned by doctor 83 (10.0) 80 (11.3) 3 (−1 to 8) Self assigned by patients 83 (18.1) 82 (19.5) 1 (−7 to 9) Time to resume normal activities (days) 3.4 (3.4) 3.4 (2.9) 0 (−1.4 to 1.3) % (No) of optimal early wound scores 92 (34/37) 89 (31/36) 3 (−11 to 17) Pain during treatment (mm)* 31 (16.4) 13 (12.0) 18 (12 to 24) Duration of treatment (min) 19 (12.8) 5 (4.6) 14 (10 to 18) No of infections 1 —

Appraisal: Randomisation Sealed envelopes: weak method of randomisation Unblinded by patient and clinician Blinded outcome Table 1 suggests balanced confounders Did randomisation work?

Validity Lots of refusals, why? / Few misses Power calculation is a little hazy t-test is the right test for normally distributed continuous data (is this normally distributed?) Single centre / Control care different to standard

The big 5 Chance Bias Confounding Fraud Is it big enough? / right stats? Bias Unblinded / weak randomisation Confounding Did randomisation work? Fraud Competing interests declared Accept Result?

Relevant question Blinding of follow-up Strengths Weakness Relevant question Blinding of follow-up Single centre Missed lots of people Unblinded ? Non-inferiority design ? Under-powered

Would you use this study? How much evidence do you need to change practice?