Clinical trial NCT05852106 - References

Congenital Heart Disease — The Effect of 3D Heart Modelling on Family Quality of Life and Surgical Success

Citation(s)

•   Abdullah KA, Reed W
  3D printing in medical imaging and healthcare services. J Med Radiat Sci. 2018 Sep;65(3):237-239. doi: 10.1002/jmrs.292. Epub 2018 Jul 3.
•   AHA
  (2023). How 3D Printing Is Impacting Clinical Care. Anatomical Models. Retrieved from https://www.aha.org/aha-center-health-innovation-market-scan/2022-06-07-3-ways-3d-printing-revolutionizing-health-care
•   Anwar S, Singh GK, Miller J, Sharma M, Manning P, Billadello JJ, Eghtesady P, Woodard PK
  3D Printing is a Transformative Technology in Congenital Heart Disease. JACC Basic Transl Sci. 2018 May 30;3(2):294-312. doi: 10.1016/j.jacbts.2017.10.003. eCollection 2018 Apr.
•   Atalay, B
  , Güler, R., & Hayli, Ç. M. (2021). Investigation of Preoperative Anxiety Levels in Pediatric Groups. Turkish Journal of Health Science and Life, 4(1), 24-26.
•   Awori J, Friedman SD, Chan T, Howard C, Seslar S, Soriano BD, Buddhe S
  3D models improve understanding of congenital heart disease. 3D Print Med. 2021 Sep 2;7(1):26. doi: 10.1186/s41205-021-00115-7.
•   Azhar AS, AlShammasi ZH, Higgi RE
  The impact of congenital heart diseases on the quality of life of patients and their families in Saudi Arabia. Biological, psychological, and social dimensions. Saudi Med J. 2016 Apr;37(4):392-402. doi: 10.15537/smj.2016.4.13626.
•   Ballard DH, Mills P, Duszak R Jr, Weisman JA, Rybicki FJ, Woodard PK
  Medical 3D Printing Cost-Savings in Orthopedic and Maxillofacial Surgery: Cost Analysis of Operating Room Time Saved with 3D Printed Anatomic Models and Surgical Guides. Acad Radiol. 2020 Aug;27(8):1103-1113. doi: 10.1016/j.acra.2019.08.011. Epub 2019 Sep 18.
•   Barsella, R
  (2020). Pilot Study: Educational Tool Reduces Parental Stress at Home Post Pediatric Cardiac Surgery.
•   Bhatla P, Tretter JT, Ludomirsky A, Argilla M, Latson LA Jr, Chakravarti S, Barker PC, Yoo SJ, McElhinney DB, Wake N, Mosca RS
  Utility and Scope of Rapid Prototyping in Patients with Complex Muscular Ventricular Septal Defects or Double-Outlet Right Ventricle: Does it Alter Management Decisions? Pediatr Cardiol. 2017 Jan;38(1):103-114. doi: 10.1007/s00246-016-1489-1. Epub 2016 Nov 11.
•   Bibb, R
  , Eggbeer, D., & Paterson, A. (2014). Medical modelling: the application of advanced design and rapid prototyping techniques in medicine: Woodhead Publishing.
•   Biber S, Andonian C, Beckmann J, Ewert P, Freilinger S, Nagdyman N, Kaemmerer H, Oberhoffer R, Pieper L, Neidenbach RC
  Current research status on the psychological situation of parents of children with congenital heart disease. Cardiovasc Diagn Ther. 2019 Oct;9(Suppl 2):S369-S376. doi: 10.21037/cdt.2019.07.07.
•   Bouma BJ, Mulder BJ
  Changing Landscape of Congenital Heart Disease. Circ Res. 2017 Mar 17;120(6):908-922. doi: 10.1161/CIRCRESAHA.116.309302.
•   Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P; CONSORT NPT Group
  CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 2017 Jul 4;167(1):40-47. doi: 10.7326/M17-0046. Epub 2017 Jun 20.
•   Boyer PJ, Yell JA, Andrews JG, Seckeler MD
  Anxiety reduction after pre-procedure meetings in patients with CHD. Cardiol Young. 2020 Jul;30(7):991-994. doi: 10.1017/S1047951120001407. Epub 2020 Jun 5.
•   Bruning J, Kramer P, Goubergrits L, Schulz A, Murin P, Solowjowa N, Kuehne T, Berger F, Photiadis J, Weixler VH
  3D modeling and printing for complex biventricular repair of double outlet right ventricle. Front Cardiovasc Med. 2022 Nov 30;9:1024053. doi: 10.3389/fcvm.2022.1024053. eCollection 2022.
•   Burkhart HM
  Simulation in congenital cardiac surgical education: We have arrived. J Thorac Cardiovasc Surg. 2017 Jun;153(6):1528-1529. doi: 10.1016/j.jtcvs.2017.03.012. Epub 2017 Mar 10. No abstract available.
•   Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D
  SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
•   Chaudhuri, A
  , Naseraldin, H., Soberg, P. V., Kroll, E., & Librus, M. (2020). Should hospitals invest in customised on-demand 3D printing for surgeries? International Journal of Operations & Production Management, 41(1), 55-62.
•   Çil, E
  (2006). Konjenital kalp hastaliklari. Turkiye Klinikleri J Int Med Sci, 2(15), 51-59.
•   Farooqi, K
  M. (2017). Rapid prototyping in cardiac disease: Springer.
•   Feins RH
  Expert commentary: Cardiothoracic surgical simulation. J Thorac Cardiovasc Surg. 2008 Mar;135(3):485-6. doi: 10.1016/j.jtcvs.2008.01.001. No abstract available.
•   Gürkan, K
  P., Bahar, Z., Çapik, C., Aydogdu, N. G., & Beser, A. (2020). Psychometric properties of the Turkish version of the pediatric quality of life: The family impact module in parents of children with type 1 diabetes. Children's Health Care, 49(1), 87-99.
•   Hartman DM, Medoff-Cooper B
  Transition to home after neonatal surgery for congenital heart disease. MCN Am J Matern Child Nurs. 2012 Mar-Apr;37(2):95-100. doi: 10.1097/NMC.0b013e318241dac1.
•   Hounsfield GN
  Computed medical imaging. Nobel lecture, Decemberr 8, 1979. J Comput Assist Tomogr. 1980 Oct;4(5):665-74. doi: 10.1097/00004728-198010000-00017. No abstract available.
•   Kain A, Mueller C, Golianu BJ, Jenkins BN, Fortier MA
  The impact of parental health mindset on postoperative recovery in children. Paediatr Anaesth. 2021 Mar;31(3):298-308. doi: 10.1111/pan.14071. Epub 2020 Nov 29.
•   Ladak LA, Hasan BS, Gullick J, Awais K, Abdullah A, Gallagher R
  Health-related quality of life in surgical children and adolescents with congenital heart disease compared with their age-matched healthy sibling: a cross-sectional study from a lower middle-income country, Pakistan. Arch Dis Child. 2019 May;104(5):419-425. doi: 10.1136/archdischild-2018-315594. Epub 2018 Dec 15.
•   Lau IWW, Liu D, Xu L, Fan Z, Sun Z
  Clinical value of patient-specific three-dimensional printing of congenital heart disease: Quantitative and qualitative assessments. PLoS One. 2018 Mar 21;13(3):e0194333. doi: 10.1371/journal.pone.0194333. eCollection 2018.
•   Liddle D, Balsara S, Hamann K, Christopher A, Olivieri L, Loke YH
  Combining patient-specific, digital 3D models with tele-education for adolescents with CHD. Cardiol Young. 2022 Jun;32(6):912-917. doi: 10.1017/S1047951121003243. Epub 2021 Aug 16.
•   Liu Y, Chen S, Zuhlke L, Black GC, Choy MK, Li N, Keavney BD
  Global birth prevalence of congenital heart defects 1970-2017: updated systematic review and meta-analysis of 260 studies. Int J Epidemiol. 2019 Apr 1;48(2):455-463. doi: 10.1093/ije/dyz009.
•   Lopez, C
  , Hanson, C. C., Yorke, D., Johnson, J. K., Mill, M. R., Brown, K. J., & Barach, P. (2017). Improving communication with families of patients undergoing pediatric cardiac surgery. Progress in Pediatric Cardiology, 45, 83-90.
•   Mahesh M
  Search for isotropic resolution in CT from conventional through multiple-row detector. Radiographics. 2002 Jul-Aug;22(4):949-62. doi: 10.1148/radiographics.22.4.g02jl14949.
•   Marino BS, Lipkin PH, Newburger JW, Peacock G, Gerdes M, Gaynor JW, Mussatto KA, Uzark K, Goldberg CS, Johnson WH Jr, Li J, Smith SE, Bellinger DC, Mahle WT; American Heart Association Congenital Heart Defects Committee, Council on Cardiovascular Disease in the Young, Council on Cardiovascular Nursing, and Stroke Council
  Neurodevelopmental outcomes in children with congenital heart disease: evaluation and management: a scientific statement from the American Heart Association. Circulation. 2012 Aug 28;126(9):1143-72. doi: 10.1161/CIR.0b013e318265ee8a. Epub 2012 Jul 30.
•   Ngan EM, Rebeyka IM, Ross DB, Hirji M, Wolfaardt JF, Seelaus R, Grosvenor A, Noga ML
  The rapid prototyping of anatomic models in pulmonary atresia. J Thorac Cardiovasc Surg. 2006 Aug;132(2):264-9. doi: 10.1016/j.jtcvs.2006.02.047.
•   Olivieri LJ, Su L, Hynes CF, Krieger A, Alfares FA, Ramakrishnan K, Zurakowski D, Marshall MB, Kim PC, Jonas RA, Nath DS
  "Just-In-Time" Simulation Training Using 3-D Printed Cardiac Models After Congenital Cardiac Surgery. World J Pediatr Congenit Heart Surg. 2016 Mar;7(2):164-8. doi: 10.1177/2150135115623961.
•   Puranik R, Muthurangu V, Celermajer DS, Taylor AM
  Congenital heart disease and multi-modality imaging. Heart Lung Circ. 2010 Mar;19(3):133-44. doi: 10.1016/j.hlc.2010.01.001. Epub 2010 Feb 23.
•   Raju TN
  The Nobel chronicles. 1979: Allan MacLeod Cormack (b 1924); and Sir Godfrey Newbold Hounsfield (b 1919). Lancet. 1999 Nov 6;354(9190):1653. doi: 10.1016/s0140-6736(05)77147-6. No abstract available.
•   Ruggiero KM, Hickey PA, Leger RR, Vessey JA, Hayman LL
  Parental perceptions of disease-severity and health-related quality of life in school-age children with congenital heart disease. J Spec Pediatr Nurs. 2018 Jan;23(1). doi: 10.1111/jspn.12204. Epub 2017 Dec 20.
•   Ryan JR, Moe TG, Richardson R, Frakes DH, Nigro JJ, Pophal S
  A novel approach to neonatal management of tetralogy of Fallot, with pulmonary atresia, and multiple aortopulmonary collaterals. JACC Cardiovasc Imaging. 2015 Jan;8(1):103-104. doi: 10.1016/j.jcmg.2014.04.030. Epub 2014 Nov 12. No abstract available.
•   Shiraishi I, Yamagishi M, Hamaoka K, Fukuzawa M, Yagihara T
  Simulative operation on congenital heart disease using rubber-like urethane stereolithographic biomodels based on 3D datasets of multislice computed tomography. Eur J Cardiothorac Surg. 2010 Feb;37(2):302-6. doi: 10.1016/j.ejcts.2009.07.046. Epub 2009 Sep 15.
•   Simeone S, Platone N, Perrone M, Marras V, Pucciarelli G, Benedetti M, Dell'Angelo G, Rea T, Guillari A, Da Valle P, Gargiulo G, Botti S, Artioli G, Comentale G, Ferrigno S, Palma G, Baratta S
  The lived experience of parents whose children discharged to home after cardiac surgery for congenital heart disease. Acta Biomed. 2018 Apr 4;89(4-S):71-77. doi: 10.23750/abm.v89i4-S.7223.
•   Staveski SL, Boulanger K, Erman L, Lin L, Almgren C, Journel C, Roth SJ, Golianu B
  The Impact of Massage and Reading on Children's Pain and Anxiety After Cardiovascular Surgery: A Pilot Study. Pediatr Crit Care Med. 2018 Aug;19(8):725-732. doi: 10.1097/PCC.0000000000001615.
•   Tabachnick, B
  , & Fidell, L. (2014). Pearson new international edition: Using multivariate statistics (Sixth). In: Pearson Education Limited
•   Tack P, Willems R, Annemans L
  An early health technology assessment of 3D anatomic models in pediatric congenital heart surgery: potential cost-effectiveness and decision uncertainty. Expert Rev Pharmacoecon Outcomes Res. 2021 Oct;21(5):1107-1115. doi: 10.1080/14737167.2021.1879645. Epub 2021 Feb 20.
•   Tenhoff, A
  C., Aggarwal, V., Ameduri, R., Deakyne, A., Iles, T. L., Said, S. M., . . . Iaizzo, P. A. (2021). Patient-Specific Three-Dimensional Computational Heart Modeling and Printing to Enhance Clinical Understandings and Treatment Planning: Congenital Recurrent Pulmonary Artery Stenosis and Transcatheter Pulmonary Valve Replacement. Paper presented at the 2021 Design of Medical Devices Conference.
•   Valverde I, Gomez-Ciriza G, Hussain T, Suarez-Mejias C, Velasco-Forte MN, Byrne N, Ordonez A, Gonzalez-Calle A, Anderson D, Hazekamp MG, Roest AAW, Rivas-Gonzalez J, Uribe S, El-Rassi I, Simpson J, Miller O, Ruiz E, Zabala I, Mendez A, Manso B, Gallego P, Prada F, Cantinotti M, Ait-Ali L, Merino C, Parry A, Poirier N, Greil G, Razavi R, Gomez-Cia T, Hosseinpour AR
  Three-dimensional printed models for surgical planning of complex congenital heart defects: an international multicentre study. Eur J Cardiothorac Surg. 2017 Dec 1;52(6):1139-1148. doi: 10.1093/ejcts/ezx208.
•   van der Linde D, Konings EE, Slager MA, Witsenburg M, Helbing WA, Takkenberg JJ, Roos-Hesselink JW
  Birth prevalence of congenital heart disease worldwide: a systematic review and meta-analysis. J Am Coll Cardiol. 2011 Nov 15;58(21):2241-7. doi: 10.1016/j.jacc.2011.08.025.
•   Varni JW, Sherman SA, Burwinkle TM, Dickinson PE, Dixon P
  The PedsQL Family Impact Module: preliminary reliability and validity. Health Qual Life Outcomes. 2004 Sep 27;2:55. doi: 10.1186/1477-7525-2-55.
•   Wang AT, Sundt TM 3rd, Cutshall SM, Bauer BA
  Massage therapy after cardiac surgery. Semin Thorac Cardiovasc Surg. 2010 Autumn;22(3):225-9. doi: 10.1053/j.semtcvs.2010.10.005.
•   Wu W, He J, Shao X
  Incidence and mortality trend of congenital heart disease at the global, regional, and national level, 1990-2017. Medicine (Baltimore). 2020 Jun 5;99(23):e20593. doi: 10.1097/MD.0000000000020593.
•   Yoo SJ, Hussein N, Peel B, Coles J, van Arsdell GS, Honjo O, Haller C, Lam CZ, Seed M, Barron D
  3D Modeling and Printing in Congenital Heart Surgery: Entering the Stage of Maturation. Front Pediatr. 2021 Feb 5;9:621672. doi: 10.3389/fped.2021.621672. eCollection 2021.
•   Yoo SJ, Spray T, Austin EH 3rd, Yun TJ, van Arsdell GS
  Hands-on surgical training of congenital heart surgery using 3-dimensional print models. J Thorac Cardiovasc Surg. 2017 Jun;153(6):1530-1540. doi: 10.1016/j.jtcvs.2016.12.054. Epub 2017 Feb 9.

The Effect of 3D Modeling on Family Quality of Life, Surgical Success and Patient Outcomes in Congenital Heart Diseases: A Randomized Controlled Trial Protocol

Details for clinical trial NCT05852106