Capstone Project Change Proposal Presentation for Faculty Review a.docx
ASBHpedsurgicalinnovation-2
1. ASBH | October 16th 2014
Pediatric Surgical Innovation
Meghan Hall
2. Disclosure
There are not any financial or relationship conflicts of
interest with the information compiled in this
presentation.
Full permission has been given by the parents/legal
guardians for use of the children’s pictures in this
presentation.
Some images maybe considered medically graphic.
3. Objectives
• Differences between Pediatric
Surgical Innovation and Pediatric
Research
• Defining “Innovative Surgeries”
• Propose three categories of
surgical innovation
• Introduce concept of an ISRB or
Independent Surgical Review
Board
4. Pediatric Research vs Surgical
Innovation
• Research is primarily for the
purposes of generalizable
knowledge
• Surgeries/Surgical innovations
are for individual benefit
• A clinical researcher has to
separate roles- clinician vs
researcher
• Surgeons can never leave their
clinical goals out of the OR
5. When the lines (start to) blur
• Unique population that cannot advocate for itself
• When a surgeon performs a “radically new
procedure”
• When an innovative surgery is performed serially
6. Belmont Report
“When a clinician departs in a significant
way from standard or accepted practice,
the innovation does not, in and of itself,
constitute research. The fact that a
procedure is "experimental," in the sense
of new, untested or different, does not
automatically place it in the category of
research. Radically new procedures of
this description should, however, be
made the object of formal research at an
early stage in order to determine whether
they are safe and effective. Thus, it is the
responsibility of medical practice
committees, for example, to insist that a
major innovation be incorporated into a
formal research project.”
7. What innovations we’re not concerned
about.
• Surgery is a “performance art”
• There are everyday anatomic
anomalies and idiosyncrasies
8. Strasberg and Lubrook (2003)
3 Criteria of Innovative Surgery:
• #1 - “[F]irst is the need for
retraining and recredentialling of
physicians..”
• Second significant innovation
“provides diagnosis or treatment
for a condition for which none
previously existed.”
• “third…would also place at risk a
healthy individuals who receives
no direct benefit in terms of
physical health from the
innovation.” (p.944)
9. Innovation Defined (cont)
Schwartz (2014) categorizes
surgical innovations on a
continuum
• Practice variation
• Transition zone
• Experimental research
10. Reasons to be concerned
• Parents often “‘grasp at
straws’ with the hope that
their very ill child may be
cured, and their ability to
objectively weigh risk versus
benefits may become
impaired.” (Schwartz, 2014)
• Pediatric surgeons have
perception of being the
“doers” (Frader and Flanagan-Klygis, 1999)
11. Innovation vs Nonvalidated- A rose by
another name.
• “[S]urgeons should be aware of the fact that
patients threatened by severe illness display a
surprising and sometimes alarming readiness
to accept uncertainty and reach out for
something new. The surgical scientist must
avoid exploiting this willingness of patients to
try something new in desperate situations.”
(Moore, 2014)
• McKneally (1999) states that “innovation has a
seductive connotation of added value,
especially in a progressive society.”
12. Table of 3 categories of innovation
1. The surgeon is
aware of the “moral
hazards” with
particularly vulnerable
parents/surrogate
decision makers with
pediatric patients. In
the consent process
the surgeon should be
particularly
transparent about
their experience with
the surgery, known
risks and potential
risks.
2. The procedure has
been performed in
animals and/or
cadavers with success
by the surgeon.
3. Colleague(s) and/or
operating team-room
consensus that the
procedure is
reasonably safe
enough to recommend
to similar or
applicable patients.
4. The procedure is
not completely novel
in humans and has
been performed with
some success by the
operating surgeon on
other patients with
the same/similar
pathological feature.
Or that the procedure
has been taught to the
operating surgeon
under direct
supervision of the
developing surgeon.
5. There has been
outside expert
consultation and peer
review of
retrospective reports
of said procedure as
done and reported by
the operating surgeon
or existing literature of
the procedure being
performed by other
surgeons.
Category 1---------------- -----------------------------------------------------------------------------------------------------------------------------------
Category 2----- ------------------------------------------------------------------------------------------------------------
Category 3----- ---------------------------------------------------------------------------
13. Category 3 Surgical Innovations
1.
• Surgeon is aware
of unique
vulnerability of
pediatric patients.
• Surgeon is
transparent on
experience and
risks.
2.
• Performed on
animals and/or
cadavers with
success
3.
• Colleague(s)
and/or operating
team-room
consensus that
the procedure is
reasonably safe
enough to
recommend to
similar or
applicable
patients.
4.
• Procedure has
been performed
with some success
by the operating
surgeon on other
patients with the
same/similar
pathological
feature.
• Or that the
procedure has
been taught to the
operating surgeon
under direct
supervision of the
developing
surgeon.
5.
• Outside expert
consultation and
peer review of
retrospective
reports of
procedure as done
and reported by
the operating
surgeon
• Or existing
literature of the
procedure being
performed by
other surgeons.
Category 3-----------------------------------------------------------------------------------------------------------------------------------------------
14. 1.
• Surgeon is aware of
unique vulnerability of
pediatric patients.
• Surgeon is transparent
on experience and risks.
2.
• Performed on animals
and/or cadavers with
success
3.
• Colleague(s) and/or
operating team-room
consensus that the
procedure is reasonably
safe enough to
recommend to similar or
applicable patients.
4.
• Procedure has been
performed with some
success by the operating
surgeon on other
patients with the
same/similar
pathological feature.
• Or that the procedure
has been taught to the
operating surgeon under
direct supervision of the
developing surgeon.
Category 2---------------------------------------------------------------------------------------------------------------------------------------------------------------------------
15. 1.
• Surgeon is aware of
unique vulnerability of
pediatric patients.
• Surgeon is transparent
on experience and
risks.
2.
• Performed on animals
and/or cadavers with
success
3.
• Colleague(s) and/or
operating team-room
consensus that the
procedure is
reasonably safe
enough to recommend
to similar or applicable
patients.
Category 1---- ---------------------------------------------------------------------------------------------------------------------------------------------------------------
16. Creation of the Independent Surgical
Review Board (ISRB) Why?
• To provide a mechanism for ethical
review of innovation before it fits the
research criteria and IRB review
• ISRB would have a more timely
response focusing solely on in-
house surgical procedures
• Foundationally different- direct
benefit to patient, surgeon unable to
shed their clinical roles. Deserves
unique ethical review
17. Fig. 2 Summary of the ETHICAL Model.
Jennifer A.T. Schwartz
Innovation in pediatric surgery:
The surgical innovation continuum and the ETHICAL model
Journal of Pediatric Surgery, Volume 49, Issue 4, 2014, 639 - 645
http://dx.doi.org/10.1016/j.jpedsurg.2013.12.016
What does the ISRB review?
18. Who sits on the ISRB?
• Immediate members
of the care team
(pediatric or neonatal
practitioners, nurses
and support staff)
• Hospital Ethics/IRB
member
• Other members of
pediatric surgical
team including other
attending pediatric
surgeons
19. Continued Requirement of Innovation
• Create National and
International Data Basis
for publishing results
• Continued competency
in innovative
procedures by “surgical
scientist” by reviewing
published results
20. Thank yous
Huge thanks to:
WFU Center for Bioethics particularly
Ana Iltis, Nancy King and Vicky Zickmund
My Family
My extended Gastroschisis family through
Avery’s Angels® Gastroschisis Foundation
21. Works Cited
• References:
• Special Protections For Children as Research Subjects. US Department of Health and Human Services. Retrieved from
http://www.hhs.gov/ohrp/policy/Children/childen.html
• The Belmont Report. US Department of Health and Human Services. Retrieved from
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
• Appendix Volume I The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research The
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Retrieved from
http://videocast.nih.gov/pdf/ohrp_appendix_belmont_report_vol_1.pdf
• Aikio et al. (2013). Early paracetamol treatment associated with lowered risk of persistent ductus arteriosus in very preterm infants. The
Journal of Maternal-Fetal and Neonatal Medicine. ISSN: 1476-7058 (print).
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• Black, N. (1999). Evidence-based Surgery: A Passing Fad? World Journal of Surgery. 23. p. 789-793.
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• Frader, J. and Flanagan-Klygis, E. (2001). Innovation and research in pediatric surgery. Seminars in pediatric surgery. 10 (4). p. 198-203.
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cohort study. Journal of American College of Surgeons. ISSN: 1072-7515/13/$36.00
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1361-1366.
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22. cont
• Kon, A., Prsa, M. and Rohlicek, C. (2013). Choices Doctors Would make if their infant had hypoplastic left heart syndrome: comparison of
survey data from 1999 to 2007. Pediatric Cardiology. 34. p. 348-353.
• Levine, R. (2005). Reflections on ‘Rethinking Research Ethics.’ The American Journal of Bioethics. 5(1). p. 1-3.
• Mastroianni, A. (2006) Liability, Regulation and Policy in Surgical Innovation: the Cutting Edge of Research and Therapy. Health Matrix:
Journal of Law-Medicine. 16(2) p. 351-442
• McKneally, M. (1999) Ethical Problems in Surgery: Innovation leading to unforeseen complications. World Journal of Surgery. 23. p. 786-
788.
• Mezu-Ndubuisi et al. (2012). Patent Ductus Arteriosus in Premature Neonates. Drugs. 72 (7) p.907-916
• Miller, M. (2000). Phase 1 Cancer Trials. Hasting Center Repot. July-August. p. 34-43.
• Mitra, S., Ronnestad, A. and Holmstrom, H. (2013) Management of Patent Ductus Arteriosus in Preterm Infants—Where do we Stand?
Congenital Heart Disorders. 8. p.500-512.
• Moore, F. (2000). Ethical Problems Special to Surgery; Surgical teaching, surgical innovation, and the surgeon in managed care. Arch surg.
135. January. p. 14-16.
• Moore, T. (2000). Successful use of the “patch, drain, and wait” laparotomy approach to perforated necrotizing enterocolitis: is hypoxia-
triggered “good angiogenesis” involved? Pediatric Surgery Int. 16. p. 356-363.
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48. p. 1822-1825.
• Neff, L, Becher, R, Blacham, A, Banks, N, Mitchell, E, Petty, J. (2012) A novel antireflux procedure: gastroplasty with restricted antrum to
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Surgery. 49. p. 639-645.
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Oversees Innovative Practice? Is There a Structure that Meets the Monitoring Needs of New Techniques? Journal of the American College of
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Editor's Notes
Pictures in my slides are of children who have undergone various experimental surgical procedures to help illustrate the “real life” of the content of my presentation.
So when do we start to get concerned? There is reason to always be concerned when entering into the “unknown” especially when there is a child, a uniquely vulnerable party involved. We also start to become concerned when an innovation starts to be performed serially. There is a duty on the part of a surgical scientist to gather and share data, make transparent what is known and not known, long term follow up and the risks involved with pursuing innovative procedures.
So the take always are: Just because it is “new, untested or different” does not make it research. The institution and professionals involved with innovative techniques and procedures should evaluate safety and effectiveness of the innovation and plans for its evaluation in a research type setting. There is ambiguity here that is concerning, especially for pediatric innovative surgical procedures. I will try now to explain what the threshold is and how to approach it.
To be sure, there is nearly daily “innovation” of even the most established procedures. This happens for several reasons. Surgery is a bit of a performance art; practice of skill, talent, time and experience all go into a surgeon’s ability. (Stirrat, 2014.) So a laparotomy maybe more “innovative” when performed by a recent graduate than by a seasoned practitioner. There are everyday “anatomic anomalies and idiosyncrasies” (Morreim, 2006) requiring a surgeon to adapt processes on the spot, this makes the procedure “novel” and innovative in application. But these are granted circumstances of “surgery”.
Stransberg and Lubrook define innovation as having any one of these 3 criteria: re-credentialing, which would in cases of new technology require some FDA regulation so there’s reason to believe that these have a little more research related protections built in. We have seen this in laparoscopic surgeries. The second is rather self explanatory, “provides diagnosis or treatment for a condition for which none previously exist.” The last one uniquely fits towards innovations that involve putting another person, other than the patient, at risk, for example, living organ donation. These terms felt lacking to me. So I sought a better model for understanding innovation. ANY SURGICAL INTERVENTION THAT MEETS AT LEAST ONE OF THESE THREE CRITERIA SHOULD BE CONSIDERED AN INNOVATIVE SURGERY.
To categorize more clearly where and when innovation occurs, Schwartz 2014 proposes a continuum I found particularly helpful.
There is the worry of parents being in Damocles’ position with a veritable sword over their head when making a decision for a medically necessary, medically fragile and/or child with a medical anomaly. Parents often “’grasp at straws’ with the hope that their very ill child may be cured, and their ability to objectively weigh risk versus benefits may become impaired.” (Schwartz, 2014). To further convolute the situation, surgeons are perceived as being “doers” and the societal and familial desire to “do something” to improve the chronic condition of a medically fragile child. This can foster an unrealistic expectation of an innovative surgery. If unaddressed, this elevated expectation, or hope, placed on an innovation. If this procedure later fails or has limited efficacy this could leave a family worse off, shattering their hope and adding in guilt and anger. Our duty here is to make as best we can, transparent the nature of the innovation and help accurately provide the expectation of the surgical innovation being proposed.
We could to better to help parents in the Damocles position foster more informed expectations of an innovative surgery by describing it accurately. As has been well noted, “words have power.” “[S]urgeons should be aware of the fact that patients threatened by severe illness display a surprising and sometimes alarming readiness to accept uncertainty and reach out for something new.” (Moore, 2014). “Innovation has a seductive connotation of added value, especially in a progressive society. Parents confronting surgical innovation, as previously reviewed, are in this unique psychological position so what we call the procedure will matter greatly in how they understand the risks.
So this is my proposed solution, however I need some input as to what these different categories should be called. As discussed, words have power, and what we term these three variant categories should accurately reflect the level of risk and innovation involved with the proposed procedure to accurately inform parents. Surgeons would term these innovations according to what category they fit in to accurately depict the level of risk and understanding of the innovation being proposed would help to avoid the “seductive connotation” of “innovation” in our progressive society.
For all 3 categories, the surgeon 1. Surgeon is aware of unique vulnerability of pediatric patients and is transparent on their experience and risks involved with the innovation. 2. The surgery has been performed on animals and/or cadavers with success. 3. Colleague(s) and/or operating team-room consensus that the procedure is reasonably safe enough to recommend to similar or applicable patients. 4. Procedure has been performed with some success by the operating surgeon on other patients with the same/similar pathological feature. Or that the procedure has been taught to the operating surgeon under direct supervision of the developing surgeon. For category 3, the 5th criteria has been filled in that these innovations have some retrospective reports existing in the literature, data base or otherwise, either by the operating surgeon or other surgeons.
Category 2 does not have retrospective reviews or literature reports of the innovative procedure, but the procedure is not novel in humans. Either this human experience is one had directly by the operating surgeon himself, or the procedure has been taught to the surgeon under direct supervision of the developing surgeon.
Category 1 would be a completely new innovative procedure, but in order to be considered on a human subject, the other 2 criteria must still be met.
PEDIATRIC SURGEONS APPEAR From careful review of many surgical papers there is a characteristic amongst pediatric surgeons to be self policing. They review with great skepticism results of other surgeons, variant outcomes and from thus have built in modes for monitoring its own professional members. However, it is worth formalizing this to protect the uniquely vulnerable population of children and to monitor instances where there is ambition and the unknown are significant. Pediatric surgeons would better serve the patient and surgical scientist through development of an Independent Surgical review board is. The ISRB would be able to review the innovations “flying under the IRB radar” that are according to the Belmont report, are not yet research. They do need some sort of formalized oversight, evolving it towards a more research type setting. As an in-house entity and solely devoted to surgery, it would have a more timely response than the IRB. Since these innovations are foundationally different than research but fly under the IRB radar, they deserve their own unique ethical review.
THE UNDERLINED AND ITALICIZED TEXT ABOVE IS NOT CLEAR. DO YOU MEAN: AND THEY HAVE BUILT-IN MODES FOR MONITORING EACH OTHER?
Schwartz model for the ETHICAL model of Pediatric Surgical innovation earmarks what the ISRB guidelines would be. The ISRB would review the Surgeon’s Expertise, Technical skills, hazards of the surgery, help draft and review the informed consent, determine conflict of interest, analysis the procedure and then retrospective reports and review the literature and encourage database reporting to help mitigate the ethical pitfalls of an ambitious surgeon. The ISRB would evaluate what was known about the proposed innovation, which category (1-3) it fell in- this would determine if it was a worthy procedure to pursue and how to term the innovation to accurately risks involved as well as set reasonable expectations for the parents.
The members that would sit on the Pediatric ISRB WOULD INCLUDEare as follows: Immediate members of the care team (pediatric or neonatal practitioners, nurses and support staff) Hospital Ethics committee member(s) and trained IRB members, other members of pediatric surgical team including other attending pediatric surgeons. Staff closest to the family would best infer the climate of the family and how best to approach informing and considering the procedure. This position would be unique to the ISRB as the IRB would not have this familiarity with the family and patient involved with the proposed innovation that would matter greatly to the proposed innovation.
THE ABOVE UNDERLINED/ITALICS IS NOT CLEAR. ARE YOU SAYING THAT THE PEOPLE MOST DIRECTLY INVOLVED WOULD USE THEIR KNOWLEDGE OF THE FAMILY TO DETERMINE THE BEST APPROACH TO SHARING INFORMATION WITH THEM AND ASKING THEM TO CONSIDER THE PROCEDURE?
IS THE GOAL TO TRY TO GET THEM TO SAY YES? OR TO HELP THEM UNDERSTAND AND APPRECIATE THE INFORMATION?
TO PROMOTE For ethical transparency for the surgical scientist the development of national and international databases SHOULD BE DEVELOPED to report positive and negative results. THIS would help to understand the risks but also improve the outcomes. It also prospectively offers more patients various options for care in rare or limited treatment. Reporting to data bases should be final step is a requirement of all “surgical scientists.”
