Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Apr 12;23(1):296.
doi: 10.1186/s13063-022-06277-x.

Patient and clinician characteristics and preferences for increasing participation in placebo surgery trials: a scoping review of attributes to inform a discrete choice experiment

Madeleine Hinwood  1   2 , Laura Wall  3 , Danielle Lang  4   5 , Zsolt J Balogh  6 , Angela Smith  7 , Michelle Dowsey  8 , Phillip Clarke  9   10 , Peter Choong  8 , Samantha Bunzli  8 , Francesco Paolucci  3
Affiliations

Patient and clinician characteristics and preferences for increasing participation in placebo surgery trials: a scoping review of attributes to inform a discrete choice experiment

Madeleine Hinwood et al. Trials. .

Abstract

Background: Orthopaedic surgeries include some of the highest volume surgical interventions globally; however, studies have shown that a significant proportion of patients report no clinically meaningful improvement in pain or function after certain procedures. As a result, there is increasing interest in conducting randomised placebo-controlled trials in orthopaedic surgery. However, these frequently fail to reach recruitment targets suggesting a need to improve trial design to encourage participation. The objective of this study was to systematically scope the available evidence on patient and clinician values and preferences which may influence the decision to participate in placebo surgery trial.

Methods: A systematic review was conducted via a literature search in the MEDLINE, Embase, PsycInfo, CINAHL, and EconLit databases as of 19 July 2021, for studies of any design (except commentaries or opinion pieces) based on two key concepts: patient and clinician characteristics, values and preferences, and placebo surgery trials.

Results: Of 3424 initial articles, we retained 18 eligible studies. Characteristics, preferences, values, and attitudes of patients (including levels of pain/function, risk/benefit perception, and altruism) and of clinicians (including concerns regarding patient deception associated with placebo, and experience/training in research) influenced their decisions to participate in placebo-controlled trials. Furthermore, some aspects of trial design, including randomisation procedures, availability of the procedure outside of the trial, and the information and consent procedures used, also influenced decisions to participate.

Conclusion: Participant recruitment is a significant challenge in placebo surgery trials, and individual decisions to participate appear to be sensitive to preferences around treatment. Understanding and quantifying the role patient and clinician preferences may play in surgical trials may contribute to the optimisation of the design and implementation of clinical trials in surgery.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
PRISMA flow diagram [32]
See this image and copyright information in PMC

References

    1. Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012;379(9823):1331–1340. doi: 10.1016/S0140-6736(11)60752-6. - DOI - PubMed
    1. Probst P, Grummich K, Harnoss JC, Hüttner FJ, Jensen K, Braun S, Kieser M, Ulrich A, Büchler MW, Diener MK. Placebo-Controlled Trials in Surgery: A Systematic Review and Meta-Analysis. Medicine. 2016;95(17):e3516. doi: 10.1097/MD.0000000000003516. - DOI - PMC - PubMed
    1. Wartolowska K, Collins GS, Hopewell S, Judge A, Dean BJF, Rombach I, Beard DJ, Carr AJ. Feasibility of surgical randomised controlled trials with a placebo arm: a systematic review. BMJ Open. 2016;6(3):e010194. doi: 10.1136/bmjopen-2015-010194. - DOI - PMC - PubMed
    1. Alzahrani K, et al. Prevalence of clinically significant improvement following total knee replacement. J Rheumatol. 2011;38(4):753–759. doi: 10.3899/jrheum.100233. - DOI - PubMed
    1. Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012;2(1):e000435. doi: 10.1136/bmjopen-2011-000435. - DOI - PMC - PubMed

Publication types