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Pediatric Surgery International

Published in:

01-09-2019 | Original Article

Non-financial conflicts of interest: contribution to a surgical dilemma by the European Reference Networks for Rare Diseases

Authors: E. Schmiedeke, S. Schaefer, D. Aminoff, N. Schwarzer, E. Jenetzky

Published in: Pediatric Surgery International | Issue 9/2019

Abstract

Purpose

Conflicts of interest can impede both research and medical treatment. The European Reference Networks require their members to deal with financial and non-financial conflicts according to an explicit protocol. In a literature review, we identified relevant interests in paediatric surgery, and drafted such a policy.

Methods

We conducted a Pubmed query and identified additional publications based on the content of the papers.

Results

58 titles were identified. According to their abstracts, 10 publications were studied in full text. A scientific taxonomy does not yet exist, but a variety of factors are mentioned. Non-financial conflicts of interest are addressed less accurately and less frequently than financial ones, especially regarding surgical treatment. Since the clinical effect of surgical volume was identified as being relevant, additional 29 respective publications were analysed. This volume-quality relationship causes conflicts of interest for the many surgeons treating a broad spectrum of rare conditions. We present a recommendation that may guide referral of patients requiring complex surgery to centres with a higher volume.

Conclusions

Non-financial conflicts of interest need to be dealt with more accuracy, especially with regard to surgery in rare, complex congenital conditions. The European Reference Networks offer a framework to mitigate these conflicts.

European Reference Networks: operational criteria for healthcare providers. https://ec.europa.eu/research/participants/data/ref/other_eu_prog/hp/guide/pse/hp-asses-manual-ern-op-criteria-hc-providers_en.pdf. Accessed 21 August 2018

(2017) Eur J Pediatr Surg 27(5):387–430

Shawwa K, Kallas R, Koujanian S, Agarwal A, Neumann I, Alexander P et al (2016) Requirements of clinical journals for authors’ Disclosure of financial and non-financial conflicts of interest: A cross sectional study. PLoS One. https://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0152301. Accessed 25 Mar 2016

Wiersma M, Kerridge I, Lipworth W (2018) Dangers of neglecting non-financial conflicts of interest in health and medicine. J Med Ethics 44:319–322CrossRefPubMed

Viswanathan M et al (2014) A proposed approach may help systematic reviews retain needed expertise while minimising bias from non-financial conflicts of interest. J Clin Epidemiol 67:1229–1238CrossRefPubMed

Hakoum M, Anouti S, Al-Gibbawi M, Abou-Jaoude EA, Hasbani DJ Cruz Lopes L, Agarwal A, Guyatt G, Akl EA (2016) Reporting of financial and non-financial conflicts of interest by authors of systematic reviews the methodological survey. BMJ Open. https://bmjopen.bmj.com/content/6/8/e011997.long. Accessed 9 Aug 2016

Abdoul H, Perrey C, Tubach F, Amiel P, Durand-Zaleski I, Alberti C (2012) Non-financial conflicts of interest in academic grant evaluation: a qualitative study of multiple stakeholders in France. PlosOne 7:4. https://doi.org/10.1371/journal.pone.0035247 CrossRef

Bero L, Grundy Q (2016) Why having a (non-financial) interest is not a conflict of interest. PLOS Biol. https://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.2001221. Accessed 13 Dec 2016

Williams J, Mayes C, Komesaroff P, Kerridge I, Lipworth W (2017) Conflicts of interest in medicine: taking diversity seriously. Internal Med J 47:734–746CrossRef

10.

Wijnen M (2017) Centralization of pediatric surgery in The Netherlands. Eur J Pediatr Surg 27:407–409CrossRefPubMed

11.

Luft HS, Bunker JP, Enthoven AC (1979) Should operations be regionalized? The empirical relation between surgical volume and mortality. N Engl J Med 301:1364–1369CrossRefPubMed

12.

Birkmeyer JD et al (2002) Hospital volume and surgical mortality in the United States. N Engl J 346:1128–1137CrossRef

13.

Bauer H, Honselmann K (2017) Minimum volume standards in surgery—are we there yet? Visc Med 33:106–116CrossRefPubMedPubMedCentral

14.

Pieper D, Mathes T, Neugebauer E, Eikermann M (2013) State of evidence on the relationship between high-volume hospitals and outcomes in surgery: a systematic review of systematic reviews. J Am Coll Surg 216(5):1015–1025.e18CrossRefPubMed

15.

Adam MA et al (2017) Is there a minimum number of thyroidectomies a surgeon should perform to optimize patient outcomes? Ann Surg 265(2):402–407CrossRefPubMed

16.

Arora S et al (2019) Defining a “high volume” radical cystectomy hospital: where do we draw the line?. Eur Urol Focus. Available online 14 February 2019. (In press). https://doi.org/10.1016/j.euf.2019.02.001

17.

Hopper AN, Jamison MH, Lewis WG (2007) Learning curves in surgical practice. Postgrad Med J 2007;83:777–779. https://pmj.bmj.com/content/83/986/777

18.

Morandi A, Ure B, Leva E, Lacher M (2015) Survey on the management of anorectal malformations (ARM) in European pediatric surgical centers of excellence. Pediatr Sug Int 31(6):543–550CrossRef

19.

Schmedding A, Rolle U (2017) Decentralized rather than centralized pediatric surgery care in Germany. Paediat Surg Int 27:399–406

20.

Durkin N, Davenport M (2017) Centralisation of paediatric surgical procedures in the United Kingdom. Paediat Surg Int 27:416–421

21.

Pellegrino ED (1992) Beneficence, scientific autonomy, and self-interest: ethical dilemmas in clinical research. Camb Q Healthc Ethics 4:361–369CrossRef

22.

Rosenberg AR (2017) “Get the consent”-nonfinancial conflict of interest in academic clinical research. J Clin Oncol 35(1):11–13CrossRefPubMed

23.

Pitak-Arnnop P, Schouman T, Bertrand JC, Hervé C (2008) How to avoid research misconduct—recommendations for surgeons. J Chir 145(6):534–541 (Main text of the article in French)CrossRef

24.

Hollack CE et al (2016) Position statement on the role of healthcare professionals, patient organizations and industry in European Reference Networks. Orphanet J Rare Dis. https://doi.org/10.1186/s13023-016-0383-5 CrossRef

25.

Saver RS (2012) Is it really all about the money? Reconsidering non-financial interests in medical research. J Law Med Ethics 40(3):467–481CrossRefPubMed

26.

Romain (2015) Conflicts of interest in research: looking out for number one means keeping the primary interest front and center. Curr Rev Musculoskelet Med 8:122–127CrossRefPubMedPubMedCentral

27.

Croskerry P, Abbass A, Wu AW (2010) Emotional influences in patient safety. J Patient Saf 6(4):199–205CrossRefPubMed

28.

Cain DM, Detsky AS (2008) Everyone's a little bit biased (even physicians). JAMA 299(24):2893–2895CrossRefPubMed

29.

Brody H (2011) Responses to peer commentaries on “clarifying conflict of interest”. Am J Bioeth 11(1):W4–W5CrossRefPubMed

30.

Shih et al (2015) Reliability of surgeon-specific reporting of complications after colectomy. Ann Surg 261(5):920–925CrossRefPubMed

31.

Nimptsch U et al (2018) Hospital volume, in-hospital mortality, and failure to rescue in esophageal surgery—an analysis of German hospital discharge data. Dtsch Arztebl Int 115:793–800PubMedPubMedCentral

32.

Vonlanthen R (2018) Toward a Consensus on Centralization in Surgery. Ann Surg. 268(5):712–724CrossRefPubMed

33.

van Kuyk EM, Wissink-Essink M, Brugman-Boezeman AT, Oerlemans HM, Nijhuis-van der Sanden MW, Severijnen RS et al (2001) Multidisciplinary behavioral treatment of defecation problems: a controlled study in children with anorectal malformations. J Pediatr Surg 36:1350–1356CrossRefPubMed

34.

Schmiedeke E, Busch M, Stamatopoulos E, Lorenz C (2008) Multidisciplinary behavioural treatment of fecal incontinence and constipation after correction of anorectal malformation. World J Pediatr 4(3):206–210CrossRefPubMed

35.

Langer JC, Gordon JS, Chen LE (2016) Subspecialisation within paediatric surgical groups in North America. J Pediatr Surg 51:143–148CrossRefPubMed

36.

Reames BN, Ghaferi AA, Birkmeyer JD, Dimick JD (2014) Hospital volume and operative mortality in the modern Era. Ann Surg 260(2):244–251CrossRefPubMed

37.

Vilanova-Sanchez A et al (2019) A descriptive model for a multidisciplinary unit for colorectal and pelvic malformations. J Pediatr Surg 54:479–485CrossRefPubMed

38.

EU Directive on the application of patients’ rights in cross-border healthcare. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex%3A32011L0024, Accessed 11 may 2019

39.

Jawaid W, Chan B, Jesudason EC (2012) Subspecialization may improve an esophageal atresia service but has not addressed declining trainee experience. J Pediatr Surg 47:1363–1368CrossRefPubMed

40.

Seshia SS, Makhinson M, Phillips DF, Young GB (2014) Evidence-informed person-centered health care (part I): do ‘cognitive biases plus’ at organizational levels influence quality of evidence? J Evaluat Clin Pract 20:734–747CrossRef

41.

Peycelon M et al (2017) French connection between specialised and routine pediatric surgical care. Paediat Surg Int 27:410–415

42.

Morche J, Mathes T, Pieper D (2016) Relationship between surgical volume and outcomes: a systematic review of systematic reviews. Syst Rev 5:204–219CrossRefPubMedPubMedCentral

43.

Butow P et al (2014) Can consultation skills training change doctors’ behaviour to increase involvement of patients in making decisions about standard treatment and clinical trials: a randomised controlled trial. Health Expect 18:2570–2583CrossRefPubMedPubMedCentral

Title: Non-financial conflicts of interest: contribution to a surgical dilemma by the European Reference Networks for Rare Diseases
Authors: E. Schmiedeke
S. Schaefer
D. Aminoff
N. Schwarzer
E. Jenetzky
Publication date: 01-09-2019
Publisher: Springer Berlin Heidelberg
Published in: Pediatric Surgery International / Issue 9/2019
Print ISSN: 0179-0358
Electronic ISSN: 1437-9813
DOI: https://doi.org/10.1007/s00383-019-04516-y

At a glance: The STEP trials

Springer Medicine

Non-financial conflicts of interest: contribution to a surgical dilemma by the European Reference Networks for Rare Diseases

Abstract

Purpose

Methods

Results

Conclusions

At a glance: The STEP trials

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusions

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