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2016 ; 95
(25
): e3790
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Surgical innovation: the ethical agenda: A systematic review
#MMPMID27336866
Broekman ML
; Carrière ME
; Bredenoord AL
Medicine (Baltimore)
2016[Jun]; 95
(25
): e3790
PMID27336866
show ga
The aim of the present article was to systematically review the ethics of
surgical innovation and introduce the components of the learning health care
system to guide future research and debate on surgical innovation.Although the
call for evidence-based practice in surgery is increasingly high on the agenda,
most surgeons feel that the format of the randomized controlled trial is not
suitable for surgery. Innovation in surgery has aspects of, but should be
distinguished from both research and clinical care and raises its own ethical
challenges.To answer the question "What are the main ethical aspects of surgical
innovation?", we systematically searched PubMed and Embase. Papers expressing an
opinion, point of view, or position were included, that is, normative ethical
papers.We included 59 studies discussing ethical aspects of surgical innovation.
These studies discussed 4 major themes: oversight, informed consent, learning
curve, and vulnerable patient groups. Although all papers addressed the ethical
challenges raised by surgical innovation, surgeons hold no uniform view of
surgical innovation, and there is no agreement on the distinction between
innovation and research. Even though most agree to some sort of oversight, they
offer different alternatives ranging from the formation of new surgical
innovation committees to establishing national registries. Most agree that
informed consent is necessary for innovative procedures and that surgeons should
be adequately trained to assure their competence to tackle the learning curve
problem. All papers agree that in case of vulnerable patients, alternatives must
be found for the informed consent procedure.We suggest that the concept of the
learning health care system might provide guidance for thinking about surgical
innovation. The underlying rationale of the learning health care system is to
improve the quality of health care by embedding research within clinical care.
Two aspects of a learning health care system might particularly enrich the
necessary future discussion on surgical innovation: integration of research and
practice and a moral emphasis on "learning activities." Future research should
evaluate whether the learning health care system and its adjacent moral framework
provides ethical guidance for evidence-based surgery.
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