ASBHpedsurgicalinnovation-2

ASBH | October 16th 2014

Pediatric Surgical Innovation

Meghan Hall

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.

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

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

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

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.”

What innovations we’re not concerned about.

• Surgery is a “performance art” • There are everyday anatomic

anomalies and idiosyncrasies

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)

Innovation Defined (cont)

Schwartz (2014) categorizes surgical innovations on a continuum• Practice variation• Transition zone • Experimental research

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)

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.”

Table of 3 categories of innovation1. 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----- ---------------------------------------------------------------------------

Category 3 Surgical Innovations1. • 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-----------------------------------------------------------------------------------------------------------------------------------------------

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---------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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---- ---------------------------------------------------------------------------------------------------------------------------------------------------------------

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

Fig. 2 Summary of the ETHICAL Model.

Jennifer A.T. Schwartz Innovation in pediatric surgery: The surgical innovation continuum and the ETHICAL modelJournal 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?

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

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

Thank yous

Huge thanks to: WFU Center for Bioethics particularly

Ana Iltis, Nancy King and Vicky ZickmundMy Family

My extended Gastroschisis family through Avery’s Angels® Gastroschisis Foundation

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).

• Beecher, H. (1961). Surgery as Placebo. Journal of the American Medical Association. 176(1). p. 1102-1107. • Black, N. (1999). Evidence-based Surgery: A Passing Fad? World Journal of Surgery. 23. p. 789-793.• Donahoe, P. (2008). The mandate for innovation in pediatric surgery; creating the environment for success, parity, and excellence.

Journal of Pediatric Surgery. 43. p. 1-7. • Frader, J. and Flanagan-Klygis, E. (2001). Innovation and research in pediatric surgery. Seminars in pediatric surgery. 10 (4). p. 198-203. • Garnett, G., Kang, K., Jaksic, T., Woo, R., Puapong, D., Kim, H and Johnson, S. (2014). First STEPs: Serial transverse enteroplasty as a

primary procedure in neonates with congenital short bowel. Journal of Pediatric Surgery. 49. p. 104-108.• Hall, J., Eaton, S and Pierro, A. (2013). Necrotizing enterocolitis: prevention, treatment, and outcome. Journal of Pediatric Surgery. 48.

p. 2359-2367. • Hardin et al. (1999). Evidence-Based Pediatric Surgery. Journal of Pediatric Surgery. 34(5). p. 908-913. • Hilts, P. (1998). Study or Human Experiment? Face lift project stirs ethical concerns. New York Times. June, 21st 1998. • Hull, M et al. (2013). Mortality and Management of Surgical Necrotizing Enterocolitis in Very Low Birth Weight Neonates: A prospective

cohort study. Journal of American College of Surgeons. ISSN: 1072-7515/13/$36.00• Hutchings et al. (2013). Outcomes following neonatal patent dectus arteriousus ligation done by pediatric surgeons: a retrospective

cohort analysis. Journal of Pediatric Surgery. 48. p.915-918. • Infantino, B et al. (2013). Successful Rehabilitation in Pediatric Ultrashort Small Bowel Syndrome. The Journal of Pediatrics. 163:5. P.

1361-1366. • Javid, P. et al. (2013). Intestinal lengthening an nutritional outcomes in children with short bowel syndrome. The American Journal of

Surgery. 205. p. 576-580. • Johnson, A. (1994). Surgery as Placebo. Lancet. 344 (8930) p.1140-1142.

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. • Morreim, H, Mack, M. and Sade, R. (2006). Surgical Innovation: Too Risky to Remain Unregulated? Annals of Thoracic Surgery. 82. p. 1957-

1965.• Morreim, H. (2005). Research versus innovation: real differences. American Journal of Bioethics. 5(1). p. 42-43. • Murray, L et al. (2013) “A Thrill of Extreme Magnety”: Robert E. Gross and the Beginnings of Cardiac Surgery. Journal of Pediatric Surgery.

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

control emesis (GRACE). Journal of Pediatric Surgery. 47(1) p.99-106. • Ozdemir, M et al. (2014). Paracetomol Therapy for Patent Ductus Arteriosus in Premature Infants: A chance for better surgical ligation.

Pediatric Cardiology. 35. p. 276-279. • Rhodes, R. (2005). Rethinking Research Ethics. The American Journal of Bioethics. 5(1). p. 7-28. • Riskin, et al. (2006). The ethics of innovation in pediatric surgery. Seminars in Pediatric Surgery. 15. p. 319-323. • Schwartz, J. (2014). Innovation in pediatric surgery: The surgical innovation continuum and the ETHICAL model. Journal of Pediatric

Surgery. 49. p. 639-645. • Slim, K. (2005). Limits of Evidence-based Surgery. World Journal of Surgery. 29. p. 606-609. • Solomon, et al (1995). Should we be performing more randomized controlled trials evaluating surgical operations? Surgery. 118 (3). p. 459-

567.

cont

• Stirrat, G. (2003). Ethics and evidence based surgery. Journal of Medical Ethics. 30. p. 160-165. Strasberg, S and Ludbrook, P. (2003). Who Oversees Innovative Practice? Is There a Structure that Meets the Monitoring Needs of New Techniques? Journal of the American College of Surgeons. 196(6). June. p. 938-948.

• Sussman, M. (2000). Ethical requirements that must be met before the introduction of new procedures. Clinical Orthopaedics and related research. 378. p. 15-22.

• Tashiro et al. (2014). Patent ductus arteriosus ligation in premature infants in the United States. Journal of Surgical Research. 30. p.1-10. • Weiz, D., More, K, McNamara, P. and Shah, P. (2014) PDA Ligation and Health Outcomes: A Meta-analysis. Pediatrics. March. 133(4). P.1024-

1046. • Wong, C. et al. (2013). Outcomes of neonatal patent ductus arteriosus ligation in Canadian neonatal units with and without pediatric cardiac

surgery programs. Journal of Pediatric Surgery. 48. p. 909-914.• Youn, et al. (2013). Outcomes of Primary Ligation of Patent Ductus Arteriosus Compared with Secondary Ligation after pharmacologic

failure in very low birth weight infants. Pediatric Cardiology. DOI: 10.1007/s00246-013-0854-6