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Assessing test-retest reliability of patient-reported outcome measures using intraclass correlation coefficients: recommendations for selecting and documenting the analytical formula.

Qin S, Nelson L, McLeod L, Eremenco S, Coons SJ.

Qual Life Res. 2019 Apr;28(4):1029-1033. doi: 10.1007/s11136-018-2076-0. Epub 2018 Dec 13.


Response scale selection in adult pain measures: results from a literature review.

Safikhani S, Gries KS, Trudeau JJ, Reasner D, Rüdell K, Coons SJ, Bush EN, Hanlon J, Abraham L, Vernon M.

J Patient Rep Outcomes. 2018 Sep 6;2:40. doi: 10.1186/s41687-018-0053-6. eCollection 2017. Review.


Response to "Use of Qualitative Data to Support Content Validity of Performance-Based Cognitive Outcome Assessments".

Ropacki MT, Hannesdottir K, Hendrix S, Gordon MF, Stephenson D, Coons SJ, Stern RA; Critical Path Institute’s Coalition Against Major Diseases and Patient-Reported Outcome Consortium Cognition Working Group.

Ther Innov Regul Sci. 2018 Jul;52(4):405-406. doi: 10.1177/2168479018771309. No abstract available.


Informing the Tolerability of Cancer Treatments Using Patient-Reported Outcome Measures: Summary of an FDA and Critical Path Institute Workshop.

Kluetz PG, Kanapuru B, Lemery S, Johnson LL, Fiero MH, Arscott K, Barbachano Y, Basch E, Campbell M, Cappelleri JC, Cella D, Cleeland C, Coens C, Daniels S, Denlinger CS, Fairclough DL, Hillard JR, Minasian L, Mitchell SA, O'Connor D, Patel S, Rubin EH, Ryden A, Soltys K, Sridhara R, Thanarajasingam G, Velikova G, Coons SJ.

Value Health. 2018 Jun;21(6):742-747. doi: 10.1016/j.jval.2017.09.009. Epub 2017 Nov 7.


Selection of and Evidentiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO Consortium.

Byrom B, Watson C, Doll H, Coons SJ, Eremenco S, Ballinger R, Mc Carthy M, Crescioni M, O'Donohoe P, Howry C; ePRO Consortium.

Value Health. 2018 Jun;21(6):631-639. doi: 10.1016/j.jval.2017.09.012. Epub 2017 Nov 7. Review.


Developing and Implementing Performance Outcome Assessments: Evidentiary, Methodologic, and Operational Considerations.

Richardson E, Burnell J, Adams HR, Bohannon RW, Bush EN, Campbell M, Chen WH, Coons SJ, Papadopoulos E, Reeve BR, Rooks D, Daniel G.

Ther Innov Regul Sci. 2019 Jan;53(1):146-153. doi: 10.1177/2168479018772569. Epub 2018 May 8.


Immediate Label-Free Ex Vivo Evaluation of Human Brain Tumor Biopsies With Confocal Reflectance Microscopy.

Eschbacher JM, Georges JF, Belykh E, Yazdanabadi MI, Martirosyan NL, Szeto E, Seiler CY, Mooney MA, Daniels JK, Goehring KY, Van Keuren-Jensen KR, Preul MC, Coons SW, Mehta S, Nakaji P.

J Neuropathol Exp Neurol. 2017 Dec 1;76(12):1008-1022. doi: 10.1093/jnen/nlx089.


Hypothalamic hamartoma: Neuropathology and epileptogenesis.

Kerrigan JF, Parsons A, Tsang C, Simeone K, Coons S, Wu J.

Epilepsia. 2017 Jun;58 Suppl 2:22-31. doi: 10.1111/epi.13752.


An extent of resection threshold for seizure freedom in patients with low-grade gliomas.

Xu DS, Awad AW, Mehalechko C, Wilson JR, Ashby LS, Coons SW, Sanai N.

J Neurosurg. 2018 Apr;128(4):1084-1090. doi: 10.3171/2016.12.JNS161682. Epub 2017 May 26.


Immediate ex-vivo diagnosis of pituitary adenomas using confocal reflectance microscopy: a proof-of-principle study.

Mooney MA, Georges J, Yazdanabadi MI, Goehring KY, White WL, Little AS, Preul MC, Coons SW, Nakaji P, Eschbacher JM.

J Neurosurg. 2018 Apr;128(4):1072-1075. doi: 10.3171/2016.11.JNS161651. Epub 2017 May 26.


Development of a harmonized patient-reported outcome questionnaire to assess myelofibrosis symptoms in clinical trials.

Gwaltney C, Paty J, Kwitkowski VE, Mesa RA, Dueck AC, Papadopoulos EJ, Wang L, Feliciano J, Coons SJ.

Leuk Res. 2017 Aug;59:26-31. doi: 10.1016/j.leukres.2017.05.012. Epub 2017 May 12.


Clinically Meaningful Outcomes in Early Alzheimer Disease: A Consortia-Driven Approach to Identifying What Matters to Patients.

Ropacki MT, Hannesdottir K, Hendrix S, Gordon MF, Stephenson D, Coons SJ, Stern RA.

Ther Innov Regul Sci. 2017 May;51(3):380-390. doi: 10.1177/2168479016689712. Epub 2017 Jan 31.


Development of the Diary for Irritable Bowel Syndrome Symptoms to Assess Treatment Benefit in Clinical Trials: Foundational Qualitative Research.

Fehnel SE, Ervin CM, Carson RT, Rigoni G, Lackner JM, Coons SJ; Critical Path Institute Patient-Reported Outcome Consortium’s Irritable Bowel Syndrome Working Group.

Value Health. 2017 Apr;20(4):618-626. doi: 10.1016/j.jval.2016.11.001. Epub 2017 Jan 3.


Interpretation of verbal descriptors for response options commonly used in verbal rating scales in patient-reported outcome instruments.

Mutebi A, Slack M, Warholak TL, Hudgens S, Coons SJ.

Qual Life Res. 2016 Dec;25(12):3181-3189. Epub 2016 Jun 13.


Radiation plus Procarbazine, CCNU, and Vincristine in Low-Grade Glioma.

Buckner JC, Shaw EG, Pugh SL, Chakravarti A, Gilbert MR, Barger GR, Coons S, Ricci P, Bullard D, Brown PD, Stelzer K, Brachman D, Suh JH, Schultz CJ, Bahary JP, Fisher BJ, Kim H, Murtha AD, Bell EH, Won M, Mehta MP, Curran WJ Jr.

N Engl J Med. 2016 Apr 7;374(14):1344-55. doi: 10.1056/NEJMoa1500925.


Qualitative Development and Content Validity of the Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ), A Patient-reported Outcome Instrument.

McCarrier KP, Atkinson TM, DeBusk KP, Liepa AM, Scanlon M, Coons SJ; Patient-Reported Outcome Consortium, Non–Small Cell Lung Cancer Working Group.

Clin Ther. 2016 Apr;38(4):794-810. doi: 10.1016/j.clinthera.2016.03.012. Epub 2016 Apr 1.


Clinical outcome assessment in malignant glioma trials: measuring signs, symptoms, and functional limitations.

Blakeley JO, Coons SJ, Corboy JR, Kline Leidy N, Mendoza TR, Wefel JS.

Neuro Oncol. 2016 Mar;18 Suppl 2:ii13-ii20. doi: 10.1093/neuonc/nov291. Review.


"Bring Your Own Device" (BYOD): The Future of Field-Based Patient-Reported Outcome Data Collection in Clinical Trials?

Gwaltney C, Coons SJ, O'Donohoe P, O'Gorman H, Denomey M, Howry C, Ross J.

Ther Innov Regul Sci. 2015 Nov;49(6):783-791. doi: 10.1177/2168479015609104.


Optimizing Electronic Capture of Clinical Outcome Assessment Data in Clinical Trials: The Case of Patient-Reported Endpoints.

Fleming S, Barsdorf AI, Howry C, O'Gorman H, Coons SJ.

Ther Innov Regul Sci. 2015 Nov;49(6):797-804. doi: 10.1177/2168479015609102.


Novel pathogenic variants and genes for myopathies identified by whole exome sequencing.

Hunter JM, Ahearn ME, Balak CD, Liang WS, Kurdoglu A, Corneveaux JJ, Russell M, Huentelman MJ, Craig DW, Carpten J, Coons SW, DeMello DE, Hall JG, Bernes SM, Baumbach-Reardon L.

Mol Genet Genomic Med. 2015 Jul;3(4):283-301. doi: 10.1002/mgg3.142. Epub 2015 Apr 8.


Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient.

Basch E, Geoghegan C, Coons SJ, Gnanasakthy A, Slagle AF, Papadopoulos EJ, Kluetz PG.

JAMA Oncol. 2015 Jun;1(3):375-9. doi: 10.1001/jamaoncol.2015.0530. Review.


Patient-Centered Research to Support the Development of the Symptoms of Major Depressive Disorder Scale (SMDDS): Initial Qualitative Research.

McCarrier KP, Deal LS, Abraham L, Blum SI, Bush EN, Martin ML, Thase ME, Coons SJ; PRO Consortium’s Depression Working Group.

Patient. 2016 Apr;9(2):117-34. doi: 10.1007/s40271-015-0132-1.


Langerhans cell histiocytosis in an adult with involvement of the calvarium, cerebral cortex and brainstem: discussion of pathophysiology and rationale for the use of intravenous immune globulin.

Dardis C, Aung T, Shapiro W, Fortune J, Coons S.

Case Rep Neurol. 2015 Feb 23;7(1):30-8. doi: 10.1159/000380760. eCollection 2015 Jan-Apr.


Erratum to: Capturing Patient-Reported Outcome (PRO) Data Electronically: The Past, Present, and Promise of ePRO Measurement in Clinical Trials.

Coons SJ, Eremenco S, Lundy JJ, O'Donohoe P, O'Gorman H, Malizia W.

Patient. 2015 Dec;8(6):571. doi: 10.1007/s40271-015-0121-4. No abstract available.


Phase 2 study of temozolomide-based chemoradiation therapy for high-risk low-grade gliomas: preliminary results of Radiation Therapy Oncology Group 0424.

Fisher BJ, Hu C, Macdonald DR, Lesser GJ, Coons SW, Brachman DG, Ryu S, Werner-Wasik M, Bahary JP, Liu J, Chakravarti A, Mehta M.

Int J Radiat Oncol Biol Phys. 2015 Mar 1;91(3):497-504. doi: 10.1016/j.ijrobp.2014.11.012. Epub 2015 Jan 30.


Long-term follow-up of surgical resection of microcystic meningiomas.

Kalani MY, Cavallo C, Coons SW, Lettieri SC, Nakaji P, Porter RW, Spetzler RF, Feiz-Erfan I.

J Clin Neurosci. 2015 Apr;22(4):713-7. doi: 10.1016/j.jocn.2014.12.004. Epub 2015 Feb 9.


The Patient-Reported Outcome (PRO) Consortium: Lessons Learned Along the Path to PRO Instrument Qualification.

Hayes RP, Blum SI, Gordon MF, Piault E, Burke LB, Slagle AF, Coons SJ.

Ther Innov Regul Sci. 2015 Jan;49(1):132-138. doi: 10.1177/2168479014549858.


Capturing Patient-Reported Outcome (PRO) Data Electronically: The Past, Present, and Promise of ePRO Measurement in Clinical Trials.

Coons SJ, Eremenco S, Lundy JJ, O'Donohoe P, O'Gorman H, Malizia W.

Patient. 2015 Aug;8(4):301-9. doi: 10.1007/s40271-014-0090-z. Erratum in: Patient. 2015 Dec;8(6):571.


A post-mortem stereological study of striatal cell number in human obesity.

Weise CM, Mouton PR, Eschbacher J, Coons SW, Krakoff J.

Obesity (Silver Spring). 2015 Jan;23(1):100-4. doi: 10.1002/oby.20897. Epub 2014 Sep 19.


PRO data collection in clinical trials using mixed modes: report of the ISPOR PRO mixed modes good research practices task force.

Eremenco S, Coons SJ, Paty J, Coyne K, Bennett AV, McEntegart D; ISPOR PRO Mixed Modes Task Force.

Value Health. 2014 Jul;17(5):501-16. doi: 10.1016/j.jval.2014.06.005.


Test-Retest Reliability of an Interactive Voice Response (IVR) Version of the EORTC QLQ-C30.

Lundy JJ, Coons SJ, Aaronson NK.

Patient. 2015 Apr;8(2):165-70. doi: 10.1007/s40271-014-0071-2.


Association of amyloid burden, brain atrophy and memory deficits in aged apolipoprotein ε4 mice.

Yin J, Turner GH, Coons SW, Maalouf M, Reiman EM, Shi J.

Curr Alzheimer Res. 2014 Mar;11(3):283-90.


Predictors of functional recovery in adults with posterior fossa ependymomas.

Mirzadeh Z, Bina R, Kusne Y, Coons SW, Spetzler RF, Sanai N.

J Neurosurg. 2014 May;120(5):1063-8. doi: 10.3171/2014.1.JNS131590. Epub 2014 Feb 28.


Pertussis toxin modulates microglia and T cell profile to protect experimental autoimmune encephalomyelitis.

Yin JX, Tang Z, Gan Y, Li L, Shi F, Coons S, Shi J.

Neuropharmacology. 2014 Jun;81:1-5. doi: 10.1016/j.neuropharm.2014.01.027. Epub 2014 Jan 29.


In vivo visualization of GL261-luc2 mouse glioma cells by use of Alexa Fluor-labeled TRP-2 antibodies.

Fenton KE, Martirosyan NL, Abdelwahab MG, Coons SW, Preul MC, Scheck AC.

Neurosurg Focus. 2014 Feb;36(2):E12. doi: 10.3171/2013.12.FOCUS13488.


An extent of resection threshold for recurrent glioblastoma and its risk for neurological morbidity.

Oppenlander ME, Wolf AB, Snyder LA, Bina R, Wilson JR, Coons SW, Ashby LS, Brachman D, Nakaji P, Porter RW, Smith KA, Spetzler RF, Sanai N.

J Neurosurg. 2014 Apr;120(4):846-53. doi: 10.3171/2013.12.JNS13184. Epub 2014 Jan 31.


The impact of extent of resection on malignant transformation of pure oligodendrogliomas.

Snyder LA, Wolf AB, Oppenlander ME, Bina R, Wilson JR, Ashby L, Brachman D, Coons SW, Spetzler RF, Sanai N.

J Neurosurg. 2014 Feb;120(2):309-14. doi: 10.3171/2013.10.JNS13368. Epub 2013 Dec 6.


Patient-reported outcomes in clinical trials of CKD-related therapies: report of a symposium sponsored by the national kidney foundation and the U.S. Food and Drug Administration.

Perrone RD, Coons SJ, Cavanaugh K, Finkelstein F, Meyer KB.

Am J Kidney Dis. 2013 Dec;62(6):1046-57. doi: 10.1053/j.ajkd.2013.07.004. Epub 2013 Aug 26.


Primary histiocytic sarcoma of the brain mimicking cerebral abscess.

Almefty RO, Tyree TL, Fusco DJ, Coons SW, Nakaji P.

J Neurosurg Pediatr. 2013 Sep;12(3):251-7. doi: 10.3171/2013.6.PEDS12533. Epub 2013 Jul 26.


ePRO systems validation: clearly defining the roles of clinical trial teams and ePRO system providers.

Coons SJ.

Value Health. 2013 Jun;16(4):457-8. doi: 10.1016/j.jval.2013.04.006. No abstract available.


Testing the measurement equivalence of paper and interactive voice response system versions of the EORTC QLQ-C30.

Lundy JJ, Coons SJ, Aaronson NK.

Qual Life Res. 2014 Feb;23(1):229-37. doi: 10.1007/s11136-013-0454-1. Epub 2013 Jun 14.


Pertussis toxin attenuates experimental autoimmune encephalomyelitis by upregulating neuronal vascular endothelial growth factor.

Tang Z, Yin JX, Han P, Gan Y, Coons SW, Wang C, Maalouf M, Shi J.

Neuroreport. 2013 Jun 19;24(9):469-75. doi: 10.1097/WNR.0b013e3283619fc8.


Hypothalamic hamartomas: neuropathological features with and without prior gamma knife radiosurgery.

Kerrigan JF, Parsons A, Rice SG, Simeone K, Shetter AG, Abla AA, Prenger E, Coons SW.

Stereotact Funct Neurosurg. 2013;91(1):45-55. doi: 10.1159/000341076. Epub 2012 Nov 29.


Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology.

Basch E, Abernethy AP, Mullins CD, Reeve BB, Smith ML, Coons SJ, Sloan J, Wenzel K, Chauhan C, Eppard W, Frank ES, Lipscomb J, Raymond SA, Spencer M, Tunis S.

J Clin Oncol. 2012 Dec 1;30(34):4249-55. doi: 10.1200/JCO.2012.42.5967. Epub 2012 Oct 15. Review.


Spinal intradural teratomas: developmental programs gone awry?

Kalani MY, Iyer S, Coons SW, Smith KA.

Neurosurg Focus. 2012 Oct;33(4):E1. doi: 10.3171/2012.8.FOCUS12230. Review.


Randomized trial of radiation therapy plus procarbazine, lomustine, and vincristine chemotherapy for supratentorial adult low-grade glioma: initial results of RTOG 9802.

Shaw EG, Wang M, Coons SW, Brachman DG, Buckner JC, Stelzer KJ, Barger GR, Brown PD, Gilbert MR, Mehta MP.

J Clin Oncol. 2012 Sep 1;30(25):3065-70. doi: 10.1200/JCO.2011.35.8598. Epub 2012 Jul 30.


Immunosignaturing can detect products from molecular markers in brain cancer.

Hughes AK, Cichacz Z, Scheck A, Coons SW, Johnston SA, Stafford P.

PLoS One. 2012;7(7):e40201. doi: 10.1371/journal.pone.0040201. Epub 2012 Jul 16.


Giant cell ependymoma-report of three cases and review of the literature.

Li JY, Lopez JI, Powell SZ, Coons SW, Fuller GN.

Int J Clin Exp Pathol. 2012;5(5):458-62. Epub 2012 May 5. Review.


Long-term radiosurgical control of subtotally resected adult pineocytomas.

Wilson DA, Awad AW, Brachman D, Coons SW, McBride H, Youssef E, Nakaji P, Shetter AG, Smith KA, Spetzler RF, Sanai N.

J Neurosurg. 2012 Aug;117(2):212-7. doi: 10.3171/2012.5.JNS1251. Epub 2012 Jun 15.


Reevaluating the imaging definition of tumor progression: perfusion MRI quantifies recurrent glioblastoma tumor fraction, pseudoprogression, and radiation necrosis to predict survival.

Hu LS, Eschbacher JM, Heiserman JE, Dueck AC, Shapiro WR, Liu S, Karis JP, Smith KA, Coons SW, Nakaji P, Spetzler RF, Feuerstein BG, Debbins J, Baxter LC.

Neuro Oncol. 2012 Jul;14(7):919-30. doi: 10.1093/neuonc/nos112. Epub 2012 May 3.

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