Clinigma| Linda Nelsen (MHS)

Linda Nelsen (MHS)

Scientific Lead

Role

Degree

MHS Epidemiology (The Johns Hopkins University Bloomberg School of Public Health), BA (University of Delaware)

Personal Info

[email protected]

About

Linda brings more than three decades of experience in patient-centred outcomes research and epidemiology within the pharmaceutical industry. As Scientific Lead at CLINIGMA®, she provides Clinical Outcome Assessment (COA) expertise across research activities, defining and leading mixed method research and guiding project teams to ensure high quality, scientifically robust deliverables. Drawing on senior leadership roles at GlaxoSmithKline and Merck Sharp & Dohme, she is a trusted partner in generating patient experience data that supports study endpoints, label claims, and market access strategies.

Expertise

Deep Clinical Trial Experience

Former Senior Director and Head of PRO Strategy and External Engagement at GlaxoSmithKline, leading COA strategy across all therapeutic areas and shaping novel approaches to PRO data, including dose optimisation in early phase oncology trials and use of real-world PRO data to enhance real-world evidence
Led COA teams to develop and implement optimal, efficient inclusion of PROs in clinical trials meeting both regulatory and HTA requirements
Nearly two decades at Merck Sharp & Dohme in epidemiology, endpoint development, validation, and post-marketing research
Led teams of COA scientists and directors, growing capability and defining career paths for early career PRO scientists
Experienced in authoring protocols, psychometric analysis plans, and clinical study reports for phase 2 to 4 clinical trials

Therapeutic Areas

Respiratory Disorders: Asthma, paediatric asthma, COPD, RSV, chronic cough
Oncology: Including PRO strategy for early phase dose optimisation
Immunologic Disorders: Rheumatoid arthritis, lupus, Sjögren's disease
Rare Diseases and Vaccines: Including hypereosinophilic syndrome and patient-reported outcomes in vaccines research
Other Areas: Women's health, migraine, hypertension

Methodological Excellence

Expert in mixed method research combining qualitative and quantitative approaches to endpoint development and validation
Specialist in qualitative protocol design, psychometric analysis plans, and estimation of meaningful change thresholds
Experienced in cultural and translation adaptation of COAs, eCOA implementation, and development of standards for exit interviews
Extensive vendor selection, oversight, and management experience across the full COA development lifecycle

Regulatory Success

Developed FDA PRO dossiers and presented at COA Staff and Division level regulatory meetings
Defined endpoint acceptance strategies in collaboration with regulatory and clinical teams, including briefing books, Type C meetings, NDA preparation, and advisory committee preparation
Led the PRO Consortium Asthma Working Group through to FDA qualification of a novel asthma symptom diary

Leadership and External Engagement

Industry Co-Director of the Critical Path Institute's PRO Consortium (2017 to 2020)
Co-Chair of the ISOQOL Measuring What Matters Symposium (2020)
Associate Editor of the Journal of Patient-Reported Outcomes (2023 to present)
Long-standing manuscript reviewer for Value in Health, Quality of Life Research, and the Journal of Patient-Reported Outcomes
Long-standing champion of patient engagement, supporting initiatives to bring patient insights into drug development early to inform patient-centric COA strategies and trial designs
Researcher at academic institutions prior to joining the pharmaceutical industry
Invited industry advisory consultant on the development of core outcome sets in response to an FDA request

Publications

Tabberer M, Williamson N, Tatlock S, Gater A, Grimes R, Akinseye C, Neil D, Mahon-Smith A, Nelsen L. Qualitative interviews of patients with COPD and muslcle weakness enrolled in a clinical trial evaluating a new anabolic treatment: patient perspectives of disease experience, trial participation and outcome assessments. J Patient Rep Outcomes. 2024 Apr 20;8(1):45

Gater A, Tolley C, Williams-Hall R, Trennery C, Bradley H, Sikirica MV, Nelsen L, Sousa AR, Bratton DJ, Chan R, von Maltzahn R. Patient-reported outcome measures for severe recurrent bilateral nasal polyps: psychometric evaluation and content validity. OTO Open. 2023 Dec 21;7(4):e84

Randall LM, O'Malley DM, Monk BJ, Coleman RL, Gaillard S, Adams S, Duska LR, Dalton H, Holloway RW, Huang M, Chon HS, Cloven NG, ElNaggar AC, O'Cearbhaill RE, Waggoner S, Tarkar A, Striha A, Nelsen LM, Baines A, Samnotra V, Konstantinopoulos PA. Niraparib and dostarlimab for the treatment of recurrent platinum-resistant ovarian cancer: results of a Phas II study (MOONSTONE/GOG-3032). Gynecol Oncol. 2023 Nov;178:161-169

Roufosse F, Butterfield J, Steinfeld J, Bentley JH, von Maltzahn R, Kwon N, Nelsen L. Mepolizumab therapy improves the most bothersome symptoms in patients with hypereosinophilic syndrome. Front Med (Lausanne). 2023 Mar 29;10:1035250

Regnault A, Loubert A, Gorsh B, Davis R, Cardellino A, Creel K, Quéré S, Sapra S, Nelsen L, Eliason L. A toolbox of different approaches to analyze and present PRO-CTCAE data in oncology studies. J Natl Cancer Inst. 2023 May 8;115(5):586-596

Eremenco S, Chen WH, Blum SI, Bush EN, Bushnell DM, DeBusk K, Gater A, Nelsen L, Coons SJ; PRO Consortium’s Communication Subcommittee. Comparing patient global impression of severity and patient global impression of change to evaualte test-retest reliability of depression, non-small cell lung cancer and asthma measures. Qual Life Res. 2022 Dec;31(12):3501-3512. doi: 10.1007/s11136-022-03180-5. Epub 2022 Jul 19.

Gater A, Nelsen L, Coon CD, Eremenco S, O'Quinn S, Khan AH, Eckert L, Staunton H, Bonner N, Hall R, Krishnan JA, Stoloff S, Schatz M, Haughney J, Coons SJ; of the Patient-Reported Outcome Consortium’s Asthma Working Group. Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttiem Symptom Diary (ANSD): Measurement Properties of Novel Patient-Reported Symptom Measurs. J Allergy Clin Immunol Pract. 2022 May;10(5):1249-1259

Sully K, Bonner N, Bradley H, von Maltzahn R, Arbuckle R, Walker-Nthenda L, Mahon A, Becker B, O'Hara L, Bevans KB, Kosinski M, Zeiger RS, Mackenzie R, Nelsen L. Development and equivalence of new faces for inclusion in the Childhood Asthma Control Test (C-ACT) response scale. J Patient Rep Outcomes. 2021 Nov 6;5(1):118.

Curran D, Cabrera ES, Nelsen L. Patient reported outcomes in vaccines research; relevance for decision making. Hum Vaccin Immunother. 2022 Dec 31;18(1):1-8. doi: 10.1080/21645515.2021.1875762. Epub 2021 Feb 19.

Nelsen LM, Kosinski M, Rizio AA, Jacques L, Schatz M, Stanford RH, Svedsater H. A Structured review evaluating content validity of the Asthma Control Test and its consistency wit US guidelines andpatient expectations for asthma control. J Asthma. 2022 Mar;59(3):628-637

Kosinski M, Nelsen L, Rizio AA, Lay-Flurrie J, von Maltzahn R, Jacques L, Schatz M, Stanford RH, Svedsater H. Psychometric properties of the Asthma Control Test in 2 randomized Clinical trials. J Allergy Clin Immunol Pract. 2021 Jan;9(1):561-563

Shen Q, von Maltzahn R, Nelsen L, Revicki D. Psychometric Properties f the Asthma Symptom Index in Patients with Severe Asthma. J Allergy Clin Immunol Pract. 2020 Aug 24:S2213- 2198(20)30835-7

Kosinski M, Nelsen L, Rizio AA, Lay-Flurrie J, von Maltzahn R, Jacques L, Schatz M, Stanford RH, SvedsaterH Psychometric properties of the Asthma Control Test in 2 randomized clinical trials. J Allergy Clin Immunol Pract. 2020 Aug 6:S2213-2198(20)30798-4.

Gairy K, Ruark K, Sinclair SM, Brandwood H, Nelsen L. An Innovative Online Qualitative Study to Explorethe Symptom Experience of Patients with Primary Sjögren's Syndrome. Rheumatol Ther. 2020 Sep;7(3):601-615.

Kovacs N, Benjamin K, Holland-Thomas N, Moshkovich O, Nelsen LM, Ortega H, Schwartz EJ, Steinfeld J, Kirby SY, Klion A, Khoury P. Symptom assessment in hypereosinophilic syndrome: Toward development of a patient-reported outcomes tool. J Allergy Clin Immunol Pract. 2020 Oct;8(9):3209-3212.e8.

Hall R, Trennery C, Chan R, Gater A, Bradley H, Sikirica MV, von Maltzahn R, Sousa AR, Nelsen LM Understanding the Patient Experience of Severe, Recurrent, Bilateral Nasal Polyps: A Qualitative Interview Study in the United States and Germany. Value Health. 2020 May;23(5):632-641.

van Dijk BCP, Svedsater H, Heddini A, Nelsen L, Balradj JS, Alleman C. Relationship between the Asthma Control Test (ACT) and other outcomes: a targeted literature review. BMC Pulm Med. 2020 Apr 3;20(1):79. doi: 10.1186/s12890-020-1090-5.

Howarth P, Chupp G, Nelsen LM, Bradford ES, Bratton DJ, Smith SG, Albers FC, Brusselle G, Bachert C.Severe eosinophilic asthma with nasal polyposis: A phenotype for improved sinonasal and asthma outcomes with mepolizumab therapy.

J Allergy Clin Immunol. 2020 Jun;145(6):1713-1715.

Müllerová H, Cockle SM, Gunsoy NB, Nelsen LM, Albers FC. Clinical characteristics and burden of illness among adolescent and adult patients with severe asthma by asthma control: the IDEAL study. J Asthma. 2020Jan 9:1-12.

Johnson PT, Bell CF, White J, Essoi B, Nelsen L, Averell CM. Observational vignette study to examinepatient and healthcare provider perceived impact of asthma-related exacerbations in the US. MultidiscipRespir Med. 2019 Nov 5;14:32.

Khurana S, Lyness JM, Mallett S, Nelsen LM, Prazma CM, Albers FC, Forshag M, Llanos JP, Yancey SW, Ortega HG. Association of depressive symptoms with health status and markers of uncontrolled severe asthma. Allergy Asthma Proc. 2019 Jul 1;40(4):230-239.

Nelsen LM, Cockle SM, Gunsoy NB, Jones P, Albers FC, Bradford ES, Mullerova H. Impact of exacerbationson St George's Respiratory Questionnaire score in patients with severe asthma: post hoc analyses of two clinical trials and an observational study. J Asthma. 2020 Sep;57(9):1006-1016.

Nelsen LM, Lee LA, Wu W, Lin X, Murray L, Pascoe SJ, Leidy NK Reliability, validity and responsiveness ofE-RS:COPD in patients with spirometric asthma-COPD overlap. Respir Res. 2019 May 31;20(1):107.

Arbuckle R, Staunton H, Sully K, Tomkins S, Khindri S, Svedsater H, Nelsen L. Use of Both Qualitative andQuantitative Methods to Estimate Meaningful Change Thresholds for Key Endpoints in Pediatric Asthma Trials. Value Health. 2019 Mar;22(3):340-347.

Staunton H, Willgoss T, Nelsen L, Burbridge C, Sully K, Rofail D, Arbuckle R An overview of using qualitative techniques to explore and define estimates of clinically important change on clinical outcome assessments. J Patient Rep Outcomes. 2019 Mar 4;3(1):16.

Reaney M, Bush E, New M, Paty J, Roborel de Climens A, Skovlund SE, Nelsen L, Flood E, Gater A The Potential Role of Individual-Level Benefit-Risk Assessment in Treatment Decision Making: A DIA Study Endpoints Community Workstream. Ther Innov Regul Sci. 2019 Sep;53(5):630-638.

Pascoe SJ, Wu W, Collison KA, Nelsen LM, Wurst KE, Lee LA. Use of clinical characteristics to predictspirometric classification of obstructive lung disease. Int J Chron Obstruct Pulmon Dis. 2018 Mar 12;13:889-902

Nelsen LM, Lenderking WR, Pokrzywinski R, Balantac Z, Black L, Pokras S, Enslin MB, Cooper M, LukesAS. Experience of Symptoms and Disease Impact in Patients with Adenomyosis. Patient. 2018Jun;11(3):319-328.

Lee L, Kerwin E, Collison K, Nelsen L, Wu W, Yang S, Pascoe S. The effect of umeclidinium on lung functionand symptoms in patients with fixed airflow obstruction and reversibility to salbutamol: A randomised, 3-phasestudy.

Respir Med. 2017 Oct;131:148-157

Albers FC, Müllerová H, Gunsoy NB, Shin JY, Nelsen LM, Bradford ES, Cockle SM, Suruki RY. Biologictreatment eligibility for real-world patients with severe asthma: The IDEAL study. J Asthma. 2018Feb;55(2):152-160.

Nelsen LM, Vernon M, Ortega H, Cockle SM, Yancey SW, Brusselle G, Albers FC, Jones PW. Evaluation of the psychometric properties of the St George's Respiratory Questionnaire in patients withsevere asthma. Respir Med. 2017 Jul;128:42-49.

Nelsen LM, Kimel M, Murray LT, Ortega H, Cockle SM, Yancey SW, Brusselle G, Albers FC, Jones PW.Qualitative evaluation of the St George's Respiratory Questionnaire in patients with severe asthma. RespirMed. 2017 May;126:32-38.

Chupp GL, Bradford ES, Albers FC, Bratton DJ, Wang-Jairaj J, Nelsen LM, Trevor JL, Magnan A, Ten Brinke A. Efficacy of mepolizumab add-on therapy on health-related quality of life and markers of asthmacontrol in severe eosinophilic asthma (MUSCA): a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 3b trial. Lancet Respir Med. 2017 May;5(5):390-400.

Black RJ, Robson JC, Goodman SM, Hoon E, Lai LYH, Simon LS, Harrison E, Neill L, Richards P,

Nelsen LM, Nebesky JM, Mackie SL, Hill CL. A Patient-reported Outcome Measure for Effect of Glucocorticoid Therapy in Adults with Inflammatory Diseases Is Needed: Report from the OMERACT 2016 Special Interest Group. J Rheumatol. 2017 Nov;44(11):1754-1758

Nelsen L, Gater A, Panter C, Tolley C, Lee L, Pascoe S. Understanding and measuring symptoms and health status in asthma COPD overlap: content validity of the EXACT and SGRQ. J Patient Rep Outcomes.2017;2(1):18.

Chupp GL, Bradford ES, Albers FC, Bratton DJ, Wang-Jaraj J, Nelsen LM, Trevor JL, Magnan A, ten Brinke A.The efficacy of mepolizumab add-on therapy on health-related quality of life and markers of asthma control inpatients with severe eosinophilic asthma: a randomised controlled trial. Lancet Resp Med 2017 (in press)

Nelsen LM, Kimrl M, Muray LT, Orgega H, Cockle SM, Yancey SW, Brusselle G, Albers FC, Jones PW.Qualitative evaluation of the St George's Respiratory Questionnaire in patients with severe asthma.Respiratory Medicine 2017. Released on-line 28-Feb-2017

Gater A, Nelsen L, Fleming S, Lundy JJ, Bonner N, Hall R, Marshall C, Staunton H, Krishnan JA, Stoloff S, Schatz M, Haughney J, Patient-reported Outcome Consortium’s Asthma Working Group. Assessing asthma symptoms in adolescents and adults: qualitative research supporting development of the Asthma Daily Symptom Diary. Value in Health 2016; 19:44-50.

Gater A., Coon C.D., Nelsen L.M., Girman C. Unique Challenges in Development, PsychometricEvaluation, and Interpretation of Daily and Event Diaries as Endpoints in Clinical Trials.

Therapeutic Innovation and Regulatory Science (2015) 49:6 (813-821). Date of Publication: 1

Nov 2015

Lu S, Hartert TV, Everard ML, Giezek H, Nelsen L, Mehta A, Patel H, Knorr B, Reiss TF. Predictors of asthma following severe respiratory syncytial virus (RSV) bronchiolitis in early childhood. Pediatr Pulmonol. 2016;51(12):1382-1392

Leidy NK, Murray LT, Monz BU, Nelsen L, Goldman M, Jones PW, Dansie EJ, Sethi S. Measuring respiratorysymptoms in clinical trials of COPD: reliability and validity of a daily diary. Respir Res. 2014;15:124

Leidy NK, Sexton CC, Jones PW, Notte SM, Monz BU, Nelsen L, Goldman M, Murray LT, Sethi S. Measuring respiratory symptoms of COPD: performance of the EXACT- Respiratory Symptoms Tool (E-RS) in three clinical trials. Thorax. 2014;69(5):443-9.

Greenberg S, Liu N, Kaur A, Lakshminarayanan M, Zhou Y, Nelsen L, Gates DF Jr, Kuo WL, Smugar SS,Reiss TF, Barnes N, Fuhlbrigge A, Milgrom H, Schatz M, Knorr B. The asthma disease activity score: a discriminating, responsive measure predicts future asthma attacks.J Allergy Clin Immunol. 2012;130(5):1071-1077..

Greenberg S, Liu N, Kaur A, Lakshminarayanan M, Zhou Y, Nelsen LM, Smugar SS, Noonan G, Reiss TF, Knorr BA. Airway obstruction lability helps distinguish levels of disease activity in asthma. Respir Med.2012;106(4):500-7.

Nelsen LM, Shields, KE, Cunningham ML, Stolder JM, Bamshad MJ, Eng PM, Smugar SS, Gould AL,Philip G. Congenital malformations among infants born to women receiving montelukast, inhaled corticosteroids and other asthma medications. JACI 2012; 129:251-254.

Ng-Mak DS, Fitzgerald KA, Norquist JM, Banderas BJ, Nelsen LM, Evand CJ. Healty CG, Ho TW, Bigal M.Key concepts of migraine postdrome: a qualitative study to develop a post-migraine questionnaire.Headache 2011; 51: 105-117.

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Vernon M, Leidy NK, Nacson A, Nelsen L. Measuring cough severity: development and pilot testing of anew seven-item cough severity patient-reported outcome measure. Ther Adv Resp Dis 2010; 4:199-208

Vernon M, Leidy NK, Nacson A, Nelsen L. Measuring cough severity: perspectives from the literature andfrom patients with chronic cough. Cough 2009;5.

Van Dole K, Swern AS, Newcomb KM, Nelsen LM. Seasonal patterns in the use of healthcare and asthma medications among preschool and school-age children. AAAI 2009; 3:105-117

Santanello, N. C., Norquist, J. M., Nelsen, L M, Knorr, B. K., Williams, V. S. L., and Bisgaard, H. Validation ofa Pediatric Caregiver Diary to Measure Symptoms of Post-Acute RSV Bronchiolitis. Pediatric Pulmonology 2005;40: 31-38. 2005.

Balkrishnan R, Nelsen LM, Kulkarni AS, Pleasants RA, Whitmire JT, Schechter MS. Outcomes associatedwith initiation of different controller therapies in a Medicaid asthmatic population: a retrospective data analysis. J Asthma 2005,1:35-40.

Allen-Ramey FC, Duong PT, Goodman DC, Sajjan SG, Nelsen LM, Markson LE. Outcomes of patients treated with fluticasone propionate or montelukast sodium. Managed Care Interface 2003;16(8):30-35.

Allen-Ramey, FC; Duong, PT; Goodman, DC; Sajjan, SG; Nelsen, LM; Santanello, NC; Markson, LE.Treatment effectiveness of inhaled corticosteroids and leukotriene modifiers for patients with asthma: An analysis from managed care date. Allergy and Asthma Proc., 2003;24(1):43-51.

Jones C; Santanello NC; Boccuzzi SJ; Wogen J; Strub P; Nelsen LM . Adherence to Prescribed Treatmentfor Asthma: Evidence from Pharmacy Benefits Data. J Asthma 2003;40(1):93-101.

Nelsen LM, Himmelberger DU, Morrison A, Berger ML, Markson LE. Quality of life questionnaire for patients on antihypertensive medication. Clinical Therapeutics 1999;21:1771-1787.

ABSTRACTS and PRESENTATIONS: (2000 and later)

Mullerova H, Gunsoy, Cockle S, Nelsen L, Albers F. Clinical characteristics and burden of illness in a cohort of severe asthma patients. Presented at European Respiratory Society (ERS), London, UK, Sept2016

Nelsen LM, Gunsoy N, Mullerova H, Cockle SM, Albers FC. Predictors of respiratory health status inpatients with severe asthma. Presented at European Respiratory Society (ERS), London, UK, Sept 2016

Nelsen L, Suruki R, Albers F, Bradford E, Cockle S, Gunsoy N, Shin J-Y. Characterization of a Severe Asthma Patient Population with and without Eosinophilic Inflammation and Frequent Exacerbations by Multiple PROs (IDEAL). ATS (2016) American Thoracic Society - 112th International Conference, san Francisco, CA, May 2016.

Suruki R, Gunsoy N, Shin J-Y, Nelsen LM, Bradford ES, Albers FC. Evaluation of US Subjects in the Identification and Description of Severe Asthma Patients in a Cross-Sectional Study—The IDEAL Study. ATS (2016) American Thoracic Society - 112th International Conference, san Francisco, CA, May 2016.

Suruki R, Gunsoy N, Shin J-Y, Nelsen LM, Bradford ES, Albers FC. Evaluation of US Subjects in the Identification and Description of Severe Asthma Patients in a Cross-Sectional Study—The IDEAL

Study. ATS (2016) American Thoracic Society - 112th International Conference, san Francisco, CA, May 2016.

Gunsoy N., Cockle S., Nelsen L., Albers F., Doyle S. Association between EQ-5D and changes in asthmasymptoms, severity, and Qol in patients with severe eosinophilic asthma. Value in Health (2016) 19:7 (A558). Presented at ISPOR, May 2016.

Albers F.C., Price R., Ortega H., Yancey S.W., Nelsen L.M., Jones P. Effect of mepolizumab in severeeosinophilic asthma patients in relation to their baseline ACQ-5 and SGRQ scores. Allergy: European Journal of Allergy and Clinical Immunology (2016) 71 Supplement 102 (257-258.

Presented at EAACI, Vienna, June 2016.

Nelsen L.M., Albers F.C., Cockle S., Jones P.W., Brusselle G., Kimel M. Qualitative evidence of contentvalidity of the SGRQ in patients with severe asthma. Allergy: European Journal of Allergy and Clinical Immunology (2016) 71 Supplement 102 (538). Presented at EAACI, Vienna, June

2016.

Albers F.C., Cockle S., Gunsoy N.B., Nelsen L.M., Mullerova H. Evaluation of patients with severe asthma eligible for treatment with mepolizumab or omalizumab, according to EU criteria.

Allergy: European Journal of Allergy and Clinical Immunology (2016) 71 Supplement 102 (540). Presented atEAACI, Vienna, June 2016.

Cockle S., Nelsen L., Kimel M., Albers F.C., Jones P. Impact of asthma exacerbations on health status inpatients with severe asthma. Journal of Allergy and Clinical Immunology (2016) 137:2 SUPPL. 1 (AB8). Presented AAAAI, San Francisco, CA, March 2016.

Nelsen L., Cockle S., Kimel M., Albers F.C., Jones P. Quantitative validity of the SGRQ in patients withsevere asthma. Journal of Allergy and Clinical Immunology (2016) 137:2 SUPPL. 1 (AB204). PresentedAAAAI, San Francisco, CA, March 2016.

Kovacs N.C., Nelsen L., Kirby S.Y., Benjamin K., Moshkovich O., Holland-Thomas N., Klion A.D., Khoury P., Steinfeld J. Patient-reported symptoms from a diverse group of subjects with hypereosinophilic syndrome.Journal of Allergy and Clinical Immunology (2016) 137:2 SUPPL. 1 (AB167). Presented AAAAI, San Francisco, CA, March 2016.

Suruki R.Y., Gunsoy N., Shin J.-Y., Daugherty J., Nelsen L., Bradford E., Albers F.C. The identification anddescription of severe asthma patients in a cross-sectional study the IDEAL study. Journal of Allergy andClinical Immunology (2016) 137:2 SUPPL. 1 (AB103). Presented AAAAI, San Francisco, CA, March 2016.

Sexton CC, Leidy N, Notte S, Jones P, Monz BU, Nelsen L, Ramachandran S, Sethi S. Reliabilty and validity of the EXACT-Respiratory Symptoms (E-RS) Score to quantify the severity of respiratory symptosm of COPD. Value in Health 2011; 14:A141.

Ng-Mak, D.S.; Fitzgerald, K.A; Norquist, J.M.; Banderas, B.F.; Nelsen, LM.; Evans, C.J.; Healy, C. G.; Ho,T.W; Bigal ,M Post-Migraine Questionnaire (PMQ): A New Instrument To Assess Symptoms and SymptomImpacts from Patients Perspective. 52nd Annual Scientific Meeting of the American Headache Society.Headache 2010; S22.

Allen-Ramey FC, Nelsen L, Kirchner HL, Leader J, Mercer D, Wasfi J, Jones JB. EHR-Based Assessmentof Oral Corticosteroid Use in A Population Of Primary Care Patients with Asthma. American Thoracic Society 2010 International Conference, New Orleans, LA. Am J Respir Crit Care Med 181;2010:3124.

Patel MD, Nelsen LM. Depressive Symptoms Among Adults with Asthma and Other Respiratory Conditions, The National Health and Nutrition Examination Survey, 2005-2006. Oral presentation at American Thoracic Society, San Diego, CA, May 2009.

Vernon MK, Nelsen LM, Nacson A, Leidy NK. Measuring cough severity: perspectives from the literature and patients with chronic cough. Oral presentation at American College of Chest Physicians 74^th Annual International Scientific Assembly, Philadelphia, PA, October 2008.

Levine K, Swern AS, Nelsen LM. Seasonal patterns of asthma healthcare utilization and medicationmedication prescriptions in preschool and school age children. Accepted as oral presentation at American College of Chest Physicians 74^th Annual International Scientific Assembly, Philadelphia, PA, October 2008.

Vernon MK, Leidy N, Nacson A, Nelsen LM. Development and pilot testing of a new 7-item cough severitypatient reported outcome measure. Accepted at European Respiratory Society 2008 Annual Conference, Berlin, Germany, September, 2008.

Nelsen LM, Marchal J, Knorr B, Brodovicz, KG, Camargo CA, Jr. Prospective study of the severity ofbronchiolitis in infants treated in urgent or emergent care and hospital settings. Presented at American Thoracic Society, Toronto, Canada, May 2008.

Vernon MK, Leidy NK, Nacson A, Nelsen LM. Attributes of cough severity from the patient’s perspective.Presented at American Thoracic Society, Toronto, Canada, May 2008.

Nelsen LM, Norquist JM, Zhu X, Gurner DM, Gorelick MH. Measuring severity of acute asthma in pediatricpatients. J Allergy Clin Immunol 2008;121:S80

Cole JA, Doherty M, Nelsen LM, Shields KE, Walker AM. Surveillance of asthma-related drugs duringpregnancy using a health insurance claims database. Pharmacoepidemiology and Drug Safety 2006;15:181.

Nelsen, LM, Norquist, JM, Diette, GB, DeMuro-Mercon, CJ, Turpin, JA, Wise, RA, and Santanello, NC.Comparison of the BDI/TDI and the USCS SOBQ to evaluate dyspnea in patients with COPD. Presented atthe American Thoracic Society 2005 International Conference, San Diego, CA, May 2005.

Nelsen LM, Norquist JM, DeMuro-MerconCJ, Turpin JA, Santanello NC, Diette GB, WiseRA. Validation of theCOPD Symptoms Diary (CSD). Presented at the European Respiratory Society Annual Congress, Glasgow, Scotland, September 2004.

Nelsen LM, Santanello NC, Williams VS, Knorr BA. Validation of a pediatric caregiver diary to measuresymptoms of post-acute RSV bronchiolitis. Accepted for presentation at the American Thoracic SocietyInternational Meeting, May 2004.

Nelsen LM, Dasbach E, Cai B, Santanello NC, Whitmire JT. Similar outcomes of montelukast and fluticasonemonotherapy on asthma resource utilization in a Medicaid population. Accepted for presentation at the American Thoracic Society International Meeting, May 2004.

‍Nelsen LM, Meyer K, Knorr B, Santanello N, Goodman D. Asthma Prevalence and Treatment in Infants and Young Children. Presented at the National Conference on Asthma Management 2003, Washington, DC,June 2003.

Nelsen L, Munns S, Whitmire JT, Balkrishnan R, Santanello N. Health Care Utilization and Medication Use among NC Medicaid Preschool Children with Persistent Asthma. Presented at the National Conference on Asthma Management 2003, Washington, DC, June 2003.

Nelsen LM, Munns S, Whitmire JT, Balkrishnan R, Santanello, NC. Longitudinal Patterns of Asthma Care in Preschool Children in a Medicaid Population. Presented at the 60^th Annual Meeting of the Academy ofAsthma, Allergy and Immunology, Denver, CO, 3/10/2003. J Allergy Clinical Immunol 2003;111:S213.

Munns S, Nelsen LM, Whitmire, JT, Balkrishnan R. Health care utilization and medication use among NCmedicaid preschool children with persistent asthma. . Presented at Chest 2002, San Diego, CA, 11/6/2002.Chest 2002;122:54S

Jones C, Allen FC, Duong PT, Sajjan S, Nelsen L, Itzler R, Markson L. Similar health care outcomes for patients treated with Fluticasone Propionate (FP) and Montelukast Sodium (MON) monotherapy. Presented at the 58^th Annual Meeting of the Academy of Asthma, Allergy and Immunology, New York, NY, 3/4/2002. J Allergy Clin Immunol 2002;109(1):S291.

Nelsen LM, Santanello NC, Knorr BA. Asthma therapies and health care resource use in children with asthma or asthma symptoms. Presented at the 5^th International Congress on Pediatric Pulmonology, Nice, France, 2/19-21/2002.

Nelsen LM, Blaiss MS, Goodman DC, Knorr BA, Santanello NC. Use of asthma therapies in infants andpreschool children. For presentation at: American College of Chest Physicians 67th Annual Meeting, Philadelphia, Pennsylvania. 11/3-7/2001. Chest 2001; 120:138S.

Nelsen LM, Santanello NC, Knorr BA, Kaplan KM. Health care utilization among infants and preschoolchildren with and without asthma. Presented at the European Respiratory Society 11^th Annual WorldCongress, Berlin Germany, 9/22-26/2001. Eur Resp J 2001; 18 (Suppl 35).

Allen FC, Ken-Yu C, Sajjan S, Coughlin MM, Nelsen LM, Duong P, Santanello NC, Markson LE. Comparison of hospital, emergency department and oral corticosteroid use in patients treated with inhaled corticosteroids and leukotriene modifiers. Am J Resp Crit Care Med 2001; 163:A641.

Nelsen LM, Carr AA, Snapinn S, Edelman JM. Health-related quality of life among patients with left ventricular hypertrophy: baseline characteristics from the Losartan Hypertension Survival Study: the LIFE Study. Am J Hypertension 2001;14:245A.

Nelsen LM, Santanello NC, Bird S, Menten J, Edelman JE, Leff JA. Measuring the influence of parental satisfaction with therapy on child adherence to asthma medication: an international validation. Presented atthe International Society for Quality of Life Research 2000 Conference, Vancouver, Canada, 10/29-31/2000.

Nelsen LM, Santanello NC, Bird S, Menten J, Leff JA. The influence of parent satisfaction and child adherence to therapy on asthma outcomes. Presented at the World Congress on Lung Health and 10^th ERS Annual Congress, August 30-September 3, 2000, Florence, Italy. Eur Resp J 2000; 16(Suppl 31):516S.

Drazen JM, Boccuzzi SJ, Wogen J, Strub P, Jones C, Nelsen L, Santanello N. Adherence and persistence to oral and inhaled asthma therapies. Presented at the World Congress on Lung Health and 10^th ERS AnnualCongress, August 30-September 3, 2000, Florence, Italy. Eur Resp J 2000; 16 (Suppl 31):565S.

Nelsen LM, Santanello NC, Bird S, Edelman J. How do parent and child satisfaction with therapy affect the child’s adherence to asthma therapy? Presented at ATS 2000 International Conference, May 5-10, 2000, Toronto, ON, Canada. Am J Resp Crit Care Med 2000; 161(3): A402.

Drazen JM, Boccuzzi SJ, Wogen J, Strub P, Jones C, Nelsen L, Santanello N. Adherence to prescribedtreatment for asthma. Presented at ATS 2000 International Conference, May 5-10, 2000, Toronto, ON, Canada. Am J Resp Crit Care Med 2000; 161(3): A402.

Nelsen L, Santanello N, Davies G, Bird, S, Edelman J. Validation of a caregiver medication satisfaction questionnaire for asthma therapy and relationship of caregiver satisfaction with child’s adherence andoutcomes. Presented at the DIA 7^th Annual Symposium of Quality of Life Evaluation, April 2-4, 2000, HiltonHead, SC.

Nelsen LM, Santanello NC, Davies G, Bird S, Edelman J. Predictors of parent satisfaction with their child’sasthma therapy. Presented at AAAAI 56^th Annual Meeting, March 3-8, 2000, San Diego, CA. J Allergy ClinImmunol 2000;105: 298S