Communicating incidental and reportable findings from research MRIs: considering factors beyond the findings in an underrepresented pediatric population.
Journal
BMC medical research methodology
ISSN: 1471-2288
Titre abrégé: BMC Med Res Methodol
Pays: England
ID NLM: 100968545
Informations de publication
Date de publication:
05 12 2021
05 12 2021
Historique:
received:
24
06
2021
accepted:
27
10
2021
entrez:
6
12
2021
pubmed:
7
12
2021
medline:
27
1
2022
Statut:
epublish
Résumé
The application of advanced imaging in pediatric research trials introduces the challenge of how to effectively handle and communicate incidental and reportable findings. This challenge is amplified in underserved populations that experience disparities in access to healthcare as recommendations for follow-up care may be difficult to coordinate. Therefore, the purpose of the present report is to describe the process for identifying and communicating findings from a research MRI to low-income Latino children and families. Latino adolescents (n = 86) aged 12-16 years old with obesity and prediabetes underwent a research MRI (3 Tesla Philips Ingenia®) as part of a randomized controlled diabetes prevention trial. The research MRIs were performed at baseline and 6 months to assess changes in whole-abdominal fat distribution and organ fat in response to the intervention. An institutional pathway was developed for identifying and reporting findings to participants and families. The pathway was developed through a collaborative process with hospital administration, research compliance, radiology, and the research team. All research images were reviewed by a board-certified pediatric radiologist who conveyed findings to the study pediatrician for determination of clinical actionability and reportability to children and families. Pediatric sub-specialists were consulted as necessary and a primary care practitioner (PCP) from a free community health clinic agreed to receive referrals for uninsured participants. A total of 139 images (86 pre- and 53 post-intervention) were reviewed with 31 findings identified and 23 deemed clinically actionable and reportable. The only reportable finding was severely elevated liver fat (> 10%, n = 14) with the most common and concerning incidental findings being horseshoe kidney (n = 1) and lung lesion (n = 1). The remainder (n = 7) were less serious. Of youth with a reportable or incidental finding, 18 had a PCP but only 7 scheduled a follow-up appointment. Seven participants without a PCP were referred to a safety-net clinic for follow-up. With the increased utilization of high-resolution imaging in pediatric research, additional standardization is needed on what, when, and how to return incidental and reportable findings to participants, particularly among historically underrepresented populations that may be underserved in the community. Preventing Diabetes in Latino Youth, NCT02615353.
Sections du résumé
BACKGROUND
The application of advanced imaging in pediatric research trials introduces the challenge of how to effectively handle and communicate incidental and reportable findings. This challenge is amplified in underserved populations that experience disparities in access to healthcare as recommendations for follow-up care may be difficult to coordinate. Therefore, the purpose of the present report is to describe the process for identifying and communicating findings from a research MRI to low-income Latino children and families.
METHODS
Latino adolescents (n = 86) aged 12-16 years old with obesity and prediabetes underwent a research MRI (3 Tesla Philips Ingenia®) as part of a randomized controlled diabetes prevention trial. The research MRIs were performed at baseline and 6 months to assess changes in whole-abdominal fat distribution and organ fat in response to the intervention. An institutional pathway was developed for identifying and reporting findings to participants and families. The pathway was developed through a collaborative process with hospital administration, research compliance, radiology, and the research team. All research images were reviewed by a board-certified pediatric radiologist who conveyed findings to the study pediatrician for determination of clinical actionability and reportability to children and families. Pediatric sub-specialists were consulted as necessary and a primary care practitioner (PCP) from a free community health clinic agreed to receive referrals for uninsured participants.
RESULTS
A total of 139 images (86 pre- and 53 post-intervention) were reviewed with 31 findings identified and 23 deemed clinically actionable and reportable. The only reportable finding was severely elevated liver fat (> 10%, n = 14) with the most common and concerning incidental findings being horseshoe kidney (n = 1) and lung lesion (n = 1). The remainder (n = 7) were less serious. Of youth with a reportable or incidental finding, 18 had a PCP but only 7 scheduled a follow-up appointment. Seven participants without a PCP were referred to a safety-net clinic for follow-up.
CONCLUSIONS
With the increased utilization of high-resolution imaging in pediatric research, additional standardization is needed on what, when, and how to return incidental and reportable findings to participants, particularly among historically underrepresented populations that may be underserved in the community.
TRIAL REGISTRATION
Preventing Diabetes in Latino Youth, NCT02615353.
Identifiants
pubmed: 34865631
doi: 10.1186/s12874-021-01459-8
pii: 10.1186/s12874-021-01459-8
pmc: PMC8647358
doi:
Banques de données
ClinicalTrials.gov
['NCT02615353']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
275Subventions
Organisme : NIDDK NIH HHS
ID : R01 DK107579
Pays : United States
Organisme : NIDDK NIH HHS
ID : F31 DK125037
Pays : United States
Informations de copyright
© 2021. The Author(s).
Références
Brain Imaging Behav. 2015 Mar;9(1):32-42
pubmed: 25403715
Pediatr Radiol. 2021 Jan;51(1):14-24
pubmed: 32588094
J Pediatr Gastroenterol Nutr. 2017 Feb;64(2):319-334
pubmed: 28107283
Pediatrics. 2015 Nov;136(5):961-8
pubmed: 26459644
Pediatrics. 2006 Oct;118(4):1388-93
pubmed: 17015527
Hastings Cent Rep. 2018 Mar;48(2):22-32
pubmed: 29590521
World J Gastroenterol. 2011 Jul 7;17(25):3012-9
pubmed: 21799647
JAMA. 2018 Aug 7;320(5):435-436
pubmed: 29931289
Soc Sci Med. 2015 May;133:145-52
pubmed: 25864151
Epidemiol Rev. 2009;31:99-112
pubmed: 19713270
J Pediatr. 2013 Mar;162(3):496-500.e1
pubmed: 23084707
BMC Health Serv Res. 2019 Dec 18;19(1):974
pubmed: 31852493
Nat Rev Endocrinol. 2018 May;14(5):270-284
pubmed: 29569621
Curr Diab Rep. 2017 Aug;17(8):60
pubmed: 28664253
J Empir Res Hum Res Ethics. 2010 Sep;5(3):31-41
pubmed: 20831419
PLoS Med. 2015 Dec 15;12(12):e1001918
pubmed: 26671224
Health Aff (Millwood). 2003 Jul-Aug;22(4):147-53
pubmed: 12889762
Health Educ Res. 2008 Oct;23(5):840-7
pubmed: 18024979
Hastings Cent Rep. 2018 May;48(3):20-28
pubmed: 29806893
J Law Med Ethics. 2008 Summer;36(2):332-340
pubmed: 18547202
J Gen Intern Med. 2019 Jun;34(6):1007-1017
pubmed: 30877457
Hastings Cent Rep. 2018 May;48(3):28-30
pubmed: 29806889
J Community Health. 2017 Aug;42(4):739-747
pubmed: 28144769
AJR Am J Roentgenol. 2015 Aug;205(2):400-8
pubmed: 26204294
J Law Med Ethics. 2010 Spring;38(1):117-26
pubmed: 20446989
Trials. 2020 Aug 14;21(1):716
pubmed: 32799920
JAMA Neurol. 2021 May 1;78(5):578-587
pubmed: 33749724
J Immigr Minor Health. 2011 Dec;13(6):1168-74
pubmed: 20607608
Pediatrics. 2009 Nov;124 Suppl 3:S306-14
pubmed: 19861485
Am J Epidemiol. 2014 Sep 15;180(6):562-4
pubmed: 25150271
World J Hepatol. 2014 May 27;6(5):274-83
pubmed: 24868321
Curr Probl Cardiol. 2019 May;44(5):148-172
pubmed: 30545650
AJR Am J Roentgenol. 2014 Dec;203(6):1192-204
pubmed: 25415696
WMJ. 2008 Dec;107(8):374-9
pubmed: 19331007
Pediatr Radiol. 2005 Jun;35(6):601-7
pubmed: 15785930
Pediatr Surg Int. 2019 May;35(5):569-574
pubmed: 30806765
J Epidemiol. 2010;20 Suppl 2:S498-504
pubmed: 20179362
J Law Med Ethics. 2008 Summer;36(2):305-14, 212
pubmed: 18547199
J Magn Reson Imaging. 2013 Nov;38(5):1009-13
pubmed: 24006134
BMC Public Health. 2017 Mar 16;17(1):261
pubmed: 28302101
AJNR Am J Neuroradiol. 2002 Nov-Dec;23(10):1674-7
pubmed: 12427622
J Urol. 2003 Nov;170(5):1722-6
pubmed: 14532762
Eur Radiol. 2013 Mar;23(3):816-26
pubmed: 22911290
Obes Rev. 2012 Aug;13(8):723-32
pubmed: 22520361
Fam Med. 1998 Mar;30(3):196-205
pubmed: 9532442
Pediatr Allergy Immunol. 2013 Jun;24(4):389-94
pubmed: 23692330
Am J Public Health. 2010 Feb;100(2):211-6
pubmed: 20019298
BMJ. 2018 Nov 22;363:k4577
pubmed: 30467245
Obes Surg. 2017 Jan;27(1):236-244
pubmed: 27822768
AJNR Am J Neuroradiol. 2013 Oct;34(10):2021-5
pubmed: 23811972
Urology. 2017 Dec;110:184-191
pubmed: 28826877
N Engl J Med. 2017 Oct 19;377(16):1593-1595
pubmed: 29045203
J Law Med Ethics. 2008 Summer;36(2):216-8
pubmed: 18547190