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The challenges faced in the design, conduct and analysis of surgical randomised controlled trials.

Cook JA - Trials (2009)

Bottom Line: Randomised evaluations of surgical interventions are rare; some interventions have been widely adopted without rigorous evaluation.However, RCTs have played a role in the assessment of surgical innovations and there is scope and need for greater use.This article will consider the design, conduct and analysis of an RCT of a surgical intervention.

View Article: PubMed Central - HTML - PubMed

Affiliation: Health Services Research Unit, University Of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, Scotland, AB25 2ZD, UK. j.a.cook@abdn.ac.uk

ABSTRACT
Randomised evaluations of surgical interventions are rare; some interventions have been widely adopted without rigorous evaluation. Unlike other medical areas, the randomised controlled trial (RCT) design has not become the default study design for the evaluation of surgical interventions. Surgical trials are difficult to successfully undertake and pose particular practical and methodological challenges. However, RCTs have played a role in the assessment of surgical innovations and there is scope and need for greater use. This article will consider the design, conduct and analysis of an RCT of a surgical intervention. The issues will be reviewed under three headings: the timing of the evaluation, defining the research question and trial design issues. Recommendations on the conduct of future surgical RCTs are made. Collaboration between research and surgical communities is needed to address the distinct issues raised by the assessment of surgical interventions and enable the conduct of appropriate and well-designed trials.

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Main constituent elements of a surgical intervention.
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Figure 1: Main constituent elements of a surgical intervention.

Mentions: Trials which evaluate a surgical intervention will come under scrutiny regarding the patient population and the integrity of the treatment groups [3,21]. A surgical intervention can be viewed as a complex intervention [45]. Figure 1 illustrates the main constituent elements. In addition to the interaction of surgeon and procedure, the wider context of the surgical team and pre-operative and post-operative care are important. Clinically unnecessary delays in receiving treatment, for example due to waiting times in a national health service context, can also influence outcome [47]. A relatively loose definition of the intervention while maintaining the coherence of the treatment will best reflect practice. A trial comparing hysterectomy versus medical management left the type and route of the intervention performed at the discretion of the gynaecologist [38]. In general, broad inclusion criteria will aid applicability of the results and is to be favoured. In the Spine Patient Outcome Research Trial, an evaluation of surgical versus non-surgical care for lumbar disc herniation, only 60% in the surgical arm received surgery while 45% in the non-surgical arm received surgery, highlighting that substantial non-compliance can occur in some situations [47]. A more explanatory approach with a tighter definition of participant inclusion and intervention can be warranted. Whatever the focus of the trial, clear reporting of how the treatment was defined and compliance is need [48].


The challenges faced in the design, conduct and analysis of surgical randomised controlled trials.

Cook JA - Trials (2009)

Main constituent elements of a surgical intervention.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2654883&req=5

Figure 1: Main constituent elements of a surgical intervention.
Mentions: Trials which evaluate a surgical intervention will come under scrutiny regarding the patient population and the integrity of the treatment groups [3,21]. A surgical intervention can be viewed as a complex intervention [45]. Figure 1 illustrates the main constituent elements. In addition to the interaction of surgeon and procedure, the wider context of the surgical team and pre-operative and post-operative care are important. Clinically unnecessary delays in receiving treatment, for example due to waiting times in a national health service context, can also influence outcome [47]. A relatively loose definition of the intervention while maintaining the coherence of the treatment will best reflect practice. A trial comparing hysterectomy versus medical management left the type and route of the intervention performed at the discretion of the gynaecologist [38]. In general, broad inclusion criteria will aid applicability of the results and is to be favoured. In the Spine Patient Outcome Research Trial, an evaluation of surgical versus non-surgical care for lumbar disc herniation, only 60% in the surgical arm received surgery while 45% in the non-surgical arm received surgery, highlighting that substantial non-compliance can occur in some situations [47]. A more explanatory approach with a tighter definition of participant inclusion and intervention can be warranted. Whatever the focus of the trial, clear reporting of how the treatment was defined and compliance is need [48].

Bottom Line: Randomised evaluations of surgical interventions are rare; some interventions have been widely adopted without rigorous evaluation.However, RCTs have played a role in the assessment of surgical innovations and there is scope and need for greater use.This article will consider the design, conduct and analysis of an RCT of a surgical intervention.

View Article: PubMed Central - HTML - PubMed

Affiliation: Health Services Research Unit, University Of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, Scotland, AB25 2ZD, UK. j.a.cook@abdn.ac.uk

ABSTRACT
Randomised evaluations of surgical interventions are rare; some interventions have been widely adopted without rigorous evaluation. Unlike other medical areas, the randomised controlled trial (RCT) design has not become the default study design for the evaluation of surgical interventions. Surgical trials are difficult to successfully undertake and pose particular practical and methodological challenges. However, RCTs have played a role in the assessment of surgical innovations and there is scope and need for greater use. This article will consider the design, conduct and analysis of an RCT of a surgical intervention. The issues will be reviewed under three headings: the timing of the evaluation, defining the research question and trial design issues. Recommendations on the conduct of future surgical RCTs are made. Collaboration between research and surgical communities is needed to address the distinct issues raised by the assessment of surgical interventions and enable the conduct of appropriate and well-designed trials.

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