Publications

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Displaying 1 through 50 of 216 publications.

Bhushan NL, DeMuro Romano C, Gras-Najjar J, Reno J, Rockwood N, Quattrone W, Adams ET, Kelly B, McLeod L, Bhavnani SP, Bocell FD, Campbell M, Kontson K, Reasner D, Zhang C, Retzky S. Remote-use applications of the amyotrophic lateral sclerosis functional rating scale-revised clinical outcome assessment tool: a scoping review. Value Health. 2024 Oct;27(10):1454-65. doi: 10.1016/j.jval.2024.05.005

Romano (DeMuro) C, Bratlee-Whhitaker E, Hartry A, Mearns E, Taylor J, Taylor G, Callahan L, Monks D, Kremer I, Lappin D, Frangiosa T, Sangodkar S, Herring WL, Gnanasakthy K, Goss D, McLeod L, Edwards T, Poulos C, DiBenedetti D, Paulsen R. Measuring what matters most to people living with Alzheimer's disease and care partners: what matters most quantitative research development. Poster presented at the Alzheimer's Association International Conference (AAIC) 2024; July 31, 2024. Philadelphia, PA.

Morga A, Zimmermann L, Valluri U, Siddiqui E, McLeod L, Bender RH. Validation and application of thresholds to define meaningful change in vasomotor symptoms frequency: analysis of pooled SKYLIGHT 1 and 2 data. Adv Ther. 2024 Jul;41(7):2845-58. doi: 10.1007/s12325-024-02849-2

McLeod L, Ervin C, Fehnel SE, Eremenco S, Carson RT, Hanlon J, Coons SJ. Psychometric evaluation of the diary for irritable bowel syndrome symptoms-constipation in a prospective observational study. Value Health. 2024 May;27(5):614-22. doi: 10.1016/j.jval.2024.01.013

Maeda-Chubachi T, McLeod L, Enloe C, Cartwright M, Siegfried E, Hebert AA, Silverberg N. Defining clinically meaningful improvement in molluscum contagiosum. J Am Acad Dermatol. 2024 Feb;90(2):443-5. doi: 10.1016/j.jaad.2023.10.033

Romano CD, Slota C, Bratlee-Whitaker E, Edwards T, Herring WL, McLeod L, Callahan L, Bullok K, Raimundo K, Taylor J, Taylor G, Kremer I, Monks D, Lappin D, Frangiosa T, Gnanasakthy K, Goss D, Comer M, Paulsen R, Hartry A, DiBenedetti D. Measuring "What Matters Most™" to individuals living with Alzheimer's disease and care partners: a conceptual model of Alzheimer's disease. Poster presented at the AAIC 2023 Conference; July 16, 2023. Amsterdam, Netherlands.

McLeod LD, Rockwood NJ. Editorial - Comparability among modes of data collection for patient-reported outcome measures: opening the gates for faithful migration. Value Health. 2023 May;26(5):620-2. doi: 10.1016/j.jval.2023.03.010

Maeda-Chubachi T, McLeod L, Cartwright M. Meaningful change in children's dermatology life quality index (DLQI) and lesion counts in patients with molluscum contagiosum. Poster presented at the First International Societies for Investigative Dermatology (ISID2023) Meeting; May 10, 2023. Tokyo, Japan. [abstract] J Invest Dermatol. 2023 May; 143(5 Suppl):S105. doi: 10.1016/j.jid.2023.03.622

Qin S, Nelson L, Williams N, Williams V, Bender R, McLeod L. Comparison of anchor-based methods for estimating thresholds of meaningful within-patient change using simulated PROMIS PF 20a data under various joint distribution characteristic conditions. Qual Life Res. 2023 May;32(5):1277-93. doi: 10.1007/s11136-022-03285-x

Lansdall CJ, McDougall F, Butler LM, Delmar P, Pross N, Qin S, McLeod L, Zhou X, Kerchner GA, Doody RS. Establishing clinically meaningful change on outcome assessments frequently used in trials of mild cognitive impairment due to Alzheimer's disease. J Prev Alzheimers Dis. 2023;10(1):9-18. doi: 10.14283/jpad.2022.102

Schlichting M, Hennig M, Rudell K, McLeod L, Bennett B, Shaw J, Doward L, Molsen-David E, Chassany O. Is IQWIG's 15% threshold universally applicable in assessing the clinical relevance of patient-reported outcomes changes? an ISPOR special interest group report. Value Health. 2022 Sep;25(9):1463-8. doi: 10.1016/j.jval.2022.07.010

Stander S, Zeidler C, Pereira M, Szepietowski JC, McLeod L, Qin S, Williams N, Sciascia T, Augustin M. Worst itch numerical rating scale for Prurigo Nodularis: a psychometric evaluation. J Eur Acad Dermatol Venereol. 2022 Apr;36(4):573-81. doi: 10.1111/jdv.17870

Qin S, McLeod L, Ma J, Cai J. Initial psychometric evaluation of the eczema symptom and impact diary in patients with moderate to severe atopic dermatitis from a phase 2 trial. Poster presented at the 2022 American Academy of Dermatology (AAD) Annual Meeting; March 25, 2022. Boston, MA.

Boyett B, Wiest K, McLeod LD, Nelson LM, Bickel WK, Learned SM, Heidbreder C, Fudala PJ, Le Moigne A, Zhao Y. Assessment of craving in opioid use disorder: psychometric evaluation and predictive validity of the opioid craving VAS. Drug Alcohol Depend. 2021 Dec 1;229(Pt B):109057. doi: 10.1016/j.drugalcdep.2021.109057

Brod M, McLeod L, Markova D, Gianettoni J, Mourya S, Lin Z, Shu A, Smith A. Psychometric validation of the Hypoparathyroidism Patient Experience Scales (HPES). J Patient Rep Outcomes. 2021 Aug 10;5(1):70. doi: 10.1186/s41687-021-00320-2

Qin S, Nelson L, McLeod L, Ma J, López Sánchez B, Gamil M, Stevens M, Jane Scott J. Psychometric evaluation of the pediatric RSV severity and outcomes rating system version 7 (PRESORSv7.1, observer-reported and PRESORSv7 clinician- reported forms) scores in young children hospitalized with respiratory syncytial virus infection. Presented at the 2021 Virtual Visual ISOQOL 28th Annual Conference; October 12, 2021. [abstract] Qual Life Res. 2021; 30(Suppl 1):S16-7. doi: https://doi.org/10.1007/s11136-021-02976-1

Fastenau J, Rozjabek H, Qin S, McLeod L, Nelson L, Ma J, Harris N. Psychometric evaluation of the DAILY EATS questionnaire in individuals living with obesity. J Patient Rep Outcomes. 2020 Nov 23;4(1):99. doi: 10.1186/s41687-020-00259-w

Reed SD, McLeod L. Moving beyond the tip of the iceberg to incorporate patients' perspectives and outcomes in the medical device regulatory process. Value Health. 2020 Mar;23(3):298-9. doi: 10.1016/j.jval.2020.01.008

Lansdall CJ, Butler LM, Kerchner G, McDougall F, Delmar P, Pross N, Qin S, McLeod L, Baudler M, Fontoura P, Doody R. Anchor- and distribution-based methods to establish clinically meaningful score changes on the Clinical Dementia Rating Scale – Sum of Boxes in patients with prodromal Alzheimer's Disease. Presented at the 12th Clinical Trials in Alzheimer’s Disease (CTAD) Meeting; December 6, 2019.

Chapman L, Richardson S, McLeod L, Rimm E, Cohen J. Pilot evaluation of aggregate plate waste as a measure of students' school lunch consumption. J Acad Nutr Diet. 2019 Dec;119(12):2093-8. doi: 10.1016/j.jand.2019.04.001

Magrey M, Bozyczko M, Wolin D, Mordin M, McLeod L, Davenport E, Chirila C, Hur P. Evaluation of the feasibility of a web-based survey to assess patient-reported symptom improvement and treatment satisfaction among patients with psoriatic arthritis receiving Secukinumab. Clin Drug Invest. 2019 Dec;39(12):1205-12. doi: 10.1007/s40261-019-00856-8

Lansdall CJ, Butler LM, Kerchner G, McDougall F, Delmar P, Pross N, Qin S, McLeod L, Baudler M, Doody R. Estimates of clinically meaningful change on the CDR-SB. Presented at the 2019 Alzheimer's Association Research Roundtable; November 20, 2019.

Eremenco S, Martin M, Doll H, Regnault A, McLeod L, Hudgens S. Clinical outcome assessment in a multi-cultural context: measurement challenges and solutions. Presented at the International Society for Quality of Life Research (ISOQOL) 26th Annual Conference; October 20, 2019. San Diego, CA. Previously presented at the 25th Annual International Society for Quality of Life Research Conference (ISOQOL).

Stover AM, McLeod L, Langer MM, Chen WH, Reeve BB. State of the psychometric methods: patient-reported outcome measure development and refinement using item response theory. J Patient Rep Outcomes. 2019 Jul 30;3(1):50. doi: 10.1186/s41687-019-0130-5.

Chapman L, Richardson S, McLeod L, Rimm E, Cohen J. Pilot evaluation of aggregate plate waste as a measure of students' school lunch consumption. Presented at the 2019 Annual Meeting of the American Society for Nutrition; June 9, 2019. Baltimore, MD. [abstract] Curr Dev Nutr. 2019 Jun 13; 3(Suppl 1):1391-2.

Magrey M, Bozyczko M, Wolin D, Mordin M, McLeod L, Davenport E, Chirila C, Park Y. A pilot study to assess the feasibility of a web-based survey to examine patient-reported symptoms and satisfaction in patients with ankylosing spondylitis receiving secukinumab. Drugs Real World Outcomes. 2019 Jun;6(2):83-91. doi: 10.1007/S40801-019-0154-4

DiBenedetti D, McLeod L, Williams N, Coles T, Tzivelekis S, Meckley LM. Development and validation of the IG Patient Experience with Treatment (IGPET), a novel patient-reported measure for individuals with primary immunodeficiency diseases. Poster presented at the 2019 ISPOR 24th Annual International Meeting; May 21, 2019. New Orleans, LA.

Qin S, Nelson L, McLeod L, Eremenco S, Coons SJ. Assessing test-retest reliability of patient-reported outcome measures using intraclass correlation coefficients: recommendations for selecting and documenting the analytical formula. Qual Life Res. 2019 Apr;28(4):1029-33. doi: 10.1007/s11136-018-2076-0

Meckley L, Coles T, Williams N, DiBenedetti D, McLeod L. Experience with immunoglobulin treatment among patients with PIDD in the US. Poster presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting; February 22, 2019. San Francisco, CA. [abstract] J Allergy Clin Immunol. 2019 Feb; 143(2 Supplement):AB112. doi: 10.1016/j.jaci.2018.12.341

Fehnel S, Ervin C, McLeod L, Carson RT, Reasner D, Hanlon J, Eremenco S, Coons SJ, PRO Consortium’s Irritable Bowel Syndrome Working Group. Psychometric evaluation of the diary for irritable bowel syndrome symptoms-constipation (DIBSS-C). Poster presented at the 2018 ISPOR 21st Annual European Congress; November 13, 2018. Barcelona, Spain.

Coles T, Meckley LM, McLeod L, Williams N, DiBenedetti D, Devercelli G. Psychometric evaluation of the immunoglobulin patient experience with treatment (IgPET) in primary immunodeficiency diseases. Poster presented at the 25th Annual International Society for Quality of Life Research Conference (ISOQOL); October 26, 2018. Dublin, Ireland.

Eremenco S, Hudgens S, McLeod L, Regnault A, Martin M. Clinical outcome assessment in a multi-cultural context: measurement challenges and solutions. Presented at the 25th Annual International Society for Quality of Life Research Conference (ISOQOL); October 24, 2018. Dublin, Ireland.

McLeod LD, Fehnel SE, Cappelleri JC. Patient-reported outcome measures: development and psychometric evaluation. In: Peace KE, Chen DG, Menon S, editors. Biopharmaceutical applied statistics symposium. Volume 1 Design of clinical trials. 1 ed. Singapore. Springer Nature Singapore Pte Ltd; 2018. p.317-46. doi: 10.1007/978-981-10-7829-3

Magrey M, Bozyczko M, Wolin D, Mordin M, McLeod L, Davenport E, Park Y. Treatment experience and satisfaction in ankylosing spondylitis patients treated with secukinumab: results from a US web-based survey. Poster presented at the 2018 Annual European Congress of Rheumatology (EULAR); June 16, 2018. Amsterdam, The Netherlands.

Odom D, McLeod L, Sherif B, Nelson L, McSorley D. Longitudinal modeling approaches to assess the association between changes in 2 clinical outcome assessments. Ther Innov Regul Sci. 2018 May;52(3):306-12. doi: 10.1177/2168479017731584

Qin S, Coles T, Nelson L, McLeod L, Williams V, Williams N, Reaney M. CDFs and PDFs: comparing visual methods supporting responder thresholds in clinical trials. Poster presented at the 2018 ISPOR 23rd Annual International Meeting; May 21, 2018. Baltimore, MD. [abstract] Value Health. 2018 May; 21(Suppl):S53. doi: 10.1016/j.jval.2018.04.442

Hanlon J, Ervin C, McLeod L, Butler A, Carson R, Coons S, Fehnel S, Kovacs S. Case study: the Diary of Irritable Bowel Syndrome Symptoms (DIBSS). Presented at the Ninth Annual PRO Consortium Workshop; April 25, 2018. Silver Spring, MD.

Hollis K, Proctor C, McBride D, Balp MM, McLeod L, Hunter S, Tian H, Khalil S, Maurer M. Comparison of Urticaria Activity Score over 7 days (UAS7) values obtained from once-daily and twice daily versions: results from the ASSURE-CSU study. Am J Clin Dermatol. 2018 Apr;19(2):267-74. doi: 10.1007/s40257-017-0331-8

Magrey M, Wolin DL, Mordin MM, McLeod LD, Davenport EK, Hur P. US patient satisfaction with Secukinumab treatment among patients with both psoriatic arthritis and psoriasis: data from a web-based survey. Poster presented at the 2018 Winter Clinical Dermatology Conference; January 2018. Hawaii. [abstract] Skin: the journal of cutaneous medicine. 2018 Feb 23; 2(2018). doi: 10.25251/skin.2.supp.25

Grange F, Mohr P, Harries M, Ehness R, Benjamin L, Siakpere O, Barth J, Stapelkamp C, Pfersch S, McLeod LD, Kaye JA, Wolowacz S, Kontoudis I. Economic burden of advanced melanoma in France, Germany, and the UK: a retrospective observational study (Melanoma Burden-of-Illness Study). Melanoma Res. 2017 Dec;27(6):607-18. doi: 10.1097/CMR.0000000000000372

Qin S, Coles T, Nelson L, Williams V, Williams N, McLeod L. What impacts the stability of anchor-based responder definitions? Presented at the ISOQOL 24th Annual Conference; October 19, 2017. Philadelphia, PA.

Quittner AL, Alpern AN, Wolin D, McLeod L, Downey C, Nelson L, Khandelwal N. Psychometric analyses of a new GI symptom tracker for cystic fibrosis. Poster presented at the 31st Annual North American Cystic Fibrosis Conference; September 19, 2017. Indianapolis, IN. [abstract] Pediatr Pulmonol. 52(S47):453.

Quittner AL, Alpern AN, Wolin D, McLeod L, Downey C, Nelson L, Khandelwal N. Pysychometric analyses of a new GI symptom tracker for cystic fibrosis. Poster presented at the 31st Annual North American Cystic Fibrosis Conference; November 2, 2017. Indianapolis, IN. [abstract] Pediatr Pulmonol. 2017 Sep 19; 52(S47):S453. doi: 10.1002/ppul.23840

Strober B, Zhao Y, Herrera V, Wolin D, McLeod L, Eid D, Bello T. Secukinumab provides greater symptom control in psoriasis-related pain, itching, and scaling compared with previous treatments: evidence from a real-world study in the US. Poster presented at the 26th EADV Congress; September 13, 2017. Geneva, Switzerland.

Strober B, Zhao Y, Herrera V, Wolin D, McLeod L, Davenport E, Bello T. Secukinumab patients achieve high overall treatment satisfaction and psoriasis-related and symptom improvement in a real world setting. Presented at the 26th EADV Congress; September 13, 2017. Geneva, Switzerland.

McLeod LD. Psychometric evaluation of patient-reported outcome measures. Presented at the Duke Industry Statistics Symposium; September 7, 2017. Durham, NC.

Mercieca-Bebber R, Rouette J, Calvert M, King MT, McLeod L, Holch P, Palmer MJ, Brundage M, ISOQOL Best Practice for PROs-Reporting Task Force. Preliminary evidence on the uptake, use, and benefits of the CONSORT-PRO extension. Qual Life Res. 2017 Jun;26(6):1427-37. doi: 10.1007/s11136-017-1508-6

Harries M, Mohr P, Grange F, Ehness R, Benjamin L, Siakpere O, Barth J, Stapelkamp C, Pfersch S, McLeod L, Wolowacz S, Kaye JA, Kontoudis I. Treatment patterns and outcomes of Stage IIIB/IIIC melanoma in France, Germany and the UK: a retrospective and prospective observational study (MELABIS). Int J Clin Pract. 2017 May 16;71(5):e12946. doi: 10.1111/ijcp.12946

McLeod L, Sikirica MV, Qin S, Joshi AV, Sweeney CT, Blum SI. Psychometric evaluation of the nausea and vomiting questionnaire in patients with type 2 diabetes mellitus receiving a glucagon-like peptide-1 receptor agonist. Poster presented at the 2017 ISPOR 22nd Annual International Meeting; May 23, 2017. Boston, MA. [abstract] Value Health. 2017 May; 20(5):A175.

McLeod L, Sikirica MV, Davenport E, Sweeney CT, Joshi AV. The impact of GLP-1 induced nausea and vomiting on work productivity and health-related quality of life in patients with T2DM. Poster presented at the 2017 ISPOR 22nd Annual International Meeting; May 23, 2017. Boston, MA. [abstract] Value Health. 2017 May; 20(5):A172.