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· DOS Abstracts
Characteristics of non-participants in orthopaedic
research – A study of patients undergoing ankle
fracture surgery and declining participation in a
randomized clinical trial
Marianne Aalykke, Erika Wernheden, Bolette Pedersen , Julie Weber Melchior
Egholm, Hanne Tønnesen
WHOCC, Clinical Health Promotion Centre, Frederiksberg Hospital; WHOCC,
Clinical Health Promotion Centre and Clinical Alcohol Research, Frederiksberg
Hospital and Lund University ; WHOCC, Clinical Health Promotion Centre
and Orthopedic Surgery, Frederiksberg Hospital and Sygehus Søndejylland
; WHOCC, Clinical Health Promtion Centre and Clinical Alcohol Research,
Frederiksberg Hospital and Lund University
Background:
Clinical experience indicates that patients declining participation
in randomized clinical trials (RCTs) are older, less healthy and of lower social sta-
tus than participants, bringing the non-participants in a higher risk at surgery.
Results from studies investigating non-participants of RCTs in surgical settings
are conflicting, and to our knowledge none of these studies exist on patients
with risky drinking, who are already at high risk at surgery.
Purpose / Aim of Study:
The aim of this study was to investigate character-
istics and outcomes of patients undergoing ankle fracture surgery with risky
drinking declining participation in the Scand-Ankle RCT.
Materials and Methods:
The Scand-Ankle study is an on-going RCT, that in-
vestigates the effect of a 6- week gold standard alcohol intervention (GSP-A)
on postoperative complications in patients drinking >21 units/week and under-
going ankle fracture surgery. This retrospective study included eligible patients
that declined to participate in the Scand-Ankle RCT, but gave informed consent
to follow-up in their medical record (N=67). Their perioperative patient charac-
teristics and 6-week complication rate were obtained from their medical record
material and the characteristics were compared to the patients enrolled in the
study so far (N=61).
Findings / Results:
The analyses on patient characteristics are on-going. 34%
of the non-participants had complications, and the most frequent complication
was wound infections.
Conclusions:
A complication rate at 34% indicates that patients drinking > 21
units/week are at high risk at ankle fracture surgery, and the analyses on patient
characteristics will show if the non-participants are at even greater risk.
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