The RAPID Consortium: A Platform for Clinical and Translational Pituitary Tumor Research

Abstract

Objectives Pituitary tumor treatment is hampered by the relative rarity of the disease, absence of a multicenter collaborative platform, and limited translational–clinical research partnerships. Prior studies offer limited insight into the formation of a multicenter consortium.

Design The authors describe the establishment of a multicenter research initiative, Registry of Adenomas of the Pituitary and Related Disorders (RAPID), to encourage quality improvement and research, promote scholarship, and apply innovative solutions in outcomes research.

Methods The challenges encountered during the formation of other research registries were reviewed with those lessons applied to the development of RAPID.

Setting/Participants RAPID was formed by 11 academic U.S. pituitary centers.

Results A Steering Committee, bylaws, data coordination center, and leadership team have been established. Clinical modules with standardized data fields for nonfunctioning adenoma, prolactinoma, acromegaly, Cushing's disease, craniopharyngioma, and Rathke's cleft cyst were created using a Health Insurance Portability and Accountability Act-compliant cloud-based platform. Currently, RAPID has received institutional review board approval at all centers, compiled retrospective data and agreements from most centers, and begun prospective data collection at one site. Existing institutional databases are being mapped to one central repository.

Conclusion The RAPID consortium has laid the foundation for a multicenter collaboration to facilitate pituitary tumor and surgical research. We sought to share our experiences so that other groups also contemplating this approach may benefit. Future studies may include outcomes benchmarking, clinically annotated biobank tissue, multicenter outcomes studies, prospective intervention studies, translational research, and health economics studies focused on value-based care questions.

Keywords

pituitary adenoma - craniopharyngioma - Cushing's disease - Rathke's cleft cyst - registry - consortium

Publikationsverlauf

Eingereicht: 10. Juli 2022

Angenommen: 07. September 2022

Accepted Manuscript online:
15. November 2022

Artikel online veröffentlicht:
30. Dezember 2022

• References

• 1 Statistics NCoVaH. Frequently Asked Questions About Medical and Public Health Registries. 2012. Accessed August 14, 2012 at: http://ncvhs.hhs.gov/9701138b.htm
• 2 Gliklich RDN, Leavy M. eds. Registries for Evaluating Patient Outcomes: A User's Guide. 3rd ed. Two volumes. (Prepared by the Outcome DEcIDE Center [Outcome Sciences, Inc., a Quintiles company] under Contract No. 290 2005 00351 TO7.). Vol. 13(14)-EHC111. Rockville, MD: Agency for Healthcare Research and Quality; 2014
• 3 Asher AL, Knightly J, Mummaneni PV. et al. Quality Outcomes Database Spine Care Project 2012-2020: milestones achieved in a collaborative North American outcomes registry to advance value-based spine care and evolution to the American Spine Registry. Neurosurg Focus 2020; 48 (05) E2
• 4 Asher AL, Khalafallah AM, Mukherjee D. et al. Launching the Quality Outcomes Database Tumor Registry: rationale, development, and pilot data. J Neurosurg 2021; 136 (02) 369-378
• 5 Kestle JRW, Riva-Cambrin J. Prospective multicenter studies in pediatric hydrocephalus. J Neurosurg Pediatr 2019; 23 (02) 135-141
• 6 Sheehan JP, Kavanagh BD, Asher A, Harbaugh RE. Inception of a national multidisciplinary registry for stereotactic radiosurgery. J Neurosurg 2016; 124 (01) 155-162
• 7 Spiotta AM, Park MS, Bellon RJ. et al. Technical success and early efficacy in 851 patients with saccular intracranial aneurysms: a subset analysis of SMART, a prospective, multicenter registry assessing the embolization of neurovascular lesions using the penumbra SMART COIL system. World Neurosurg 2021; 155: e323-e334
• 8 Yahanda AT, Adelson PD, Akbari SHA. et al. Dural augmentation approaches and complication rates after posterior fossa decompression for Chiari I malformation and syringomyelia: a Park-Reeves Syringomyelia Research Consortium study. J Neurosurg Pediatr 2021; 27 (04) 459-468
• 9 Hutchinson PJ, Edlmann E, Bulters D. et al; British Neurosurgical Trainee Research Collaborative, Dex-CSDH Trial Collaborators. Trial of dexamethasone for chronic subdural hematoma. N Engl J Med 2020; 383 (27) 2616-2627
• 10 Saeger W, Lüdecke DK, Buchfelder M, Fahlbusch R, Quabbe HJ, Petersenn S. Pathohistological classification of pituitary tumors: 10 years of experience with the German Pituitary Tumor Registry. Eur J Endocrinol 2007; 156 (02) 203-216
• 11 Reincke M, Petersenn S, Buchfelder M. et al. The German Acromegaly Registry: description of the database and initial results. Exp Clin Endocrinol Diabetes 2006; 114 (09) 498-505
• 12 Clusmann H, Höllig A. Craniopharyngioma: the benefits of a conservative approach. Dtsch Arztebl Int 2019; 116 (18) 319-320
• 13 Luque RM, Ibáñez-Costa A, Sánchez-Tejada L. et al; investigadores del REMAH. The Molecular Registry of Pituitary Adenomas (REMAH): a bet of Spanish Endocrinology for the future of individualized medicine and translational research. Endocrinol Nutr 2016; 63 (06) 274-284
• 14 Mooney MA, Sarris CE, Zhou JJ. et al; TRANSSPHER Study Group. Proposal and validation of a simple grading scale (TRANSSPHER Grade) for predicting gross total resection of nonfunctioning pituitary macroadenomas after transsphenoidal surgery. Oper Neurosurg (Hagerstown) 2019; 17 (05) 460-469
• 15 Mooney MA, Herro AM, Fintelmann RE. et al. Visual field outcome reporting in neurosurgery: lessons learned from a prospective, multicenter study of transsphenoidal pituitary surgery. World Neurosurg 2018; 120: e326-e332
• 16 Little AS, Kelly DF, White WL. et al; TRANSSPHER Study Group. Results of a prospective multicenter controlled study comparing surgical outcomes of microscopic versus fully endoscopic transsphenoidal surgery for nonfunctioning pituitary adenomas: the Transsphenoidal Extent of Resection (TRANSSPHER) Study. J Neurosurg 2019; 132 (04) 1043-1053
• 17 Little AS, Gardner PA, Fernandez-Miranda JC. et al; TRANSSPHER Study Group. Pituitary gland recovery following fully endoscopic transsphenoidal surgery for nonfunctioning pituitary adenoma: results of a prospective multicenter study. J Neurosurg 2019; 133 (06) 1732-1738
• 18 Little AS, Chicoine MR, Kelly DF. et al; TRANSSPHER Study Group. Evaluation of surgical resection goal and its relationship to extent of resection and patient outcomes in a multicenter prospective study of patients with surgically treated, nonfunctioning pituitary adenomas: a case series. Oper Neurosurg (Hagerstown) 2020; 18 (01) 26-33
• 19 Karsy M, Akbari SH, Limbrick D. et al. Evaluation of pediatric glioma outcomes using intraoperative MRI: a multicenter cohort study. J Neurooncol 2019; 143 (02) 271-280
• 20 Yahanda AT, Patel B, Shah AS. et al. Impact of intraoperative magnetic resonance imaging and other factors on surgical outcomes for newly diagnosed grade II astrocytomas and oligodendrogliomas: a multicenter study. Neurosurgery 2020; 88 (01) 63-73
• 21 Shah AS, Yahanda AT, Sylvester PT. et al. Using histopathology to assess the reliability of intraoperative magnetic resonance imaging in guiding additional brain tumor resection: a multicenter study. Neurosurgery 2020; 88 (01) E49-E59
• 22 Shah AS, Sylvester PT, Yahanda AT. et al. Intraoperative MRI for newly diagnosed supratentorial glioblastoma: a multicenter-registry comparative study to conventional surgery. J Neurosurg 2020;
• 23 Little AS, Kshettry VR, Rosen MR. et al. Postoperative oral antibiotics and sinonasal outcomes following endoscopic transsphenoidal surgery for pituitary tumors study: a multicenter, prospective, randomized, double-blinded, placebo-controlled study. Neurosurgery 2021; 89 (05) 769-776
• 24 (ICMJE) ICoMJE. International Committee of Medical Journal Editors. Recommendations for conduct, reporting, editing, and publication of scholarly work in medical journals. 2021. Accessed October 20, 2021 at: http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html
• 25 Calcagno HE, Lucke-Wold B, Noles M. et al. Integrated otolaryngology and anesthesia simulation model for crisis management of cavernous carotid artery injury. Arch Neurol Neuro Disord 2018; 1 (01) 30-41
• 26 Chaskes MB, Barton B, Karsy M. et al. An algorithm for sellar reconstruction following endoscopic transsphenoidal surgery for pituitary adenoma: a review of 582 cases. Int Forum Allergy Rhinol 2022; 12 (09) 1120-1130
• 27 Thakur JD, Corlin A, Mallari RJ. et al. Complication avoidance protocols in endoscopic pituitary adenoma surgery: a retrospective cohort study in 514 patients. Pituitary 2021; 24 (06) 930-942
• 28 AlQahtani A, Castelnuovo P, Nicolai P, Prevedello DM, Locatelli D, Carrau RL. Injury of the internal carotid artery during endoscopic skull base surgery: prevention and management protocol. Otolaryngol Clin North Am 2016; 49 (01) 237-252