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Abstract
Introduction Randomised controlled trials (RCTs)
with a placebo comparator are considered the gold
standard study design when evaluating healthcare
interventions. These are challenging to design and
deliver in surgery. Guidance recommends pilot and
feasibility work to optimise main trial design and
conduct; however, the extent to which this occurs in
surgery is unknown.
Method A systematic review identified randomised
placebo-controlled surgical trials. Articles published
from database inception to 31 December 2020 were
retrieved from Ovid-MEDLINE, Ovid-EMBASE and
CENTRAL electronic databases, hand-searching and
expert knowledge. Pilot/feasibility work conducted
prior to the RCTs was then identified from examining
citations and reference lists. Where studies explicitly
stated their intent to inform the design and/or conduct
of the future main placebo-controlled surgical trial,
they were included. Publication type, clinical area,
treatment intervention, number of centres, sample
size, comparators, aims and text about the invasive
placebo intervention were extracted.
Results From 131 placebo surgical RCTs included
in the systematic review, 47 potentially eligible pilot/
feasibility studies were identified. Of these, four were
included as true pilot/feasibility work. Three were
original articles, one a conference abstract; three
were conducted in orthopaedic surgery and one in
oral and maxillofacial surgery. All four included pilot
RCTs, with an invasive surgical placebo intervention,
randomising 9–49 participants in 1 or 2 centres.
They explored the acceptability of recruitment and
the invasive placebo intervention to patients and
trial personnel, and whether blinding was possible.
One study examined the characteristics of the
proposed invasive placebo intervention using in-depth
interviews.
Conclusion Published studies reporting feasibility/
pilot work undertaken to inform main placebo
surgical trials are scarce. In view of the difficulties of
undertaking placebo surgical trials, it is recommended
that pilot/feasibility studies are conducted, and more
are reported to share key findings and optimise the
design of main RCTs.
with a placebo comparator are considered the gold
standard study design when evaluating healthcare
interventions. These are challenging to design and
deliver in surgery. Guidance recommends pilot and
feasibility work to optimise main trial design and
conduct; however, the extent to which this occurs in
surgery is unknown.
Method A systematic review identified randomised
placebo-controlled surgical trials. Articles published
from database inception to 31 December 2020 were
retrieved from Ovid-MEDLINE, Ovid-EMBASE and
CENTRAL electronic databases, hand-searching and
expert knowledge. Pilot/feasibility work conducted
prior to the RCTs was then identified from examining
citations and reference lists. Where studies explicitly
stated their intent to inform the design and/or conduct
of the future main placebo-controlled surgical trial,
they were included. Publication type, clinical area,
treatment intervention, number of centres, sample
size, comparators, aims and text about the invasive
placebo intervention were extracted.
Results From 131 placebo surgical RCTs included
in the systematic review, 47 potentially eligible pilot/
feasibility studies were identified. Of these, four were
included as true pilot/feasibility work. Three were
original articles, one a conference abstract; three
were conducted in orthopaedic surgery and one in
oral and maxillofacial surgery. All four included pilot
RCTs, with an invasive surgical placebo intervention,
randomising 9–49 participants in 1 or 2 centres.
They explored the acceptability of recruitment and
the invasive placebo intervention to patients and
trial personnel, and whether blinding was possible.
One study examined the characteristics of the
proposed invasive placebo intervention using in-depth
interviews.
Conclusion Published studies reporting feasibility/
pilot work undertaken to inform main placebo
surgical trials are scarce. In view of the difficulties of
undertaking placebo surgical trials, it is recommended
that pilot/feasibility studies are conducted, and more
are reported to share key findings and optimise the
design of main RCTs.
| Original language | English |
|---|---|
| Article number | e071094 |
| Pages (from-to) | e071094 |
| Number of pages | 8 |
| Journal | BMJ Open |
| Volume | 13 |
| Issue number | 11 |
| DOIs | |
| Publication status | Published - 20 Nov 2023 |
Bibliographical note
Funding Information:This work was supported by the National Institute for Health and Care Research Biomedical Research Centre at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol (BRC-1215-20011).
Publisher Copyright:
© 2023 Author(s). Published by BMJ.
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HARMONY – HeAlthieR sMiles fOr children with cleft bY improving caries prevention and management
Gormley, A. J. (Principal Investigator), Main, B. G. J. (Co-Investigator), Wren, Y. E. (Co-Investigator), Lewis, S. J. (Co-Investigator) & Rooshenas, L. (Co-Investigator)
1/11/22 → 31/10/25
Project: Research