Verifying participant-reported clinical outcomes: challenges and implications.

Trials
Suzanne BreemanSeonaidh Cotton

Abstract

Researchers often rely on trial participants to self-report clinical outcomes (for example, fractures, re-operations). Little information exists as to the 'accuracy' of participant-reported clinical outcomes, particularly in randomised controlled trials (RCTs). To help address this evidence gap, we report four case studies, nested within different RCTs where participant-reported clinical outcome data were compared with those reported by clinicians or extracted from medical notes. Four publicly-funded RCTs with different methods of verifying participant-reported outcomes were identified. In KAT, the participants were asked about hospital admissions for any reason. Where it was thought to be relevant to the trial knee, further information was sought from the lead surgeon at the admitting site to confirm whether or not the admission was relevant to the trial knee. In REFLUX, participants were asked about hospital admissions for any reason. For participants who reported a re-operation, further information was sought from the lead surgeon at the admitting site to confirm this. In RECORD, participants were asked three questions regarding broken bones. Where low-trauma fractures were reported, clinical verification was sought, initial...Continue Reading

References

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Methods Mentioned

BETA
X-ray

Clinical Trials Mentioned

ISRCTN45837371
ISRCTN15517081
ISRCTN51647438
ISRCTN75198618

Software Mentioned

RECORD
KAT
REFLUX
CATHETER

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