Publications

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Displaying 1 through 50 of 59 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 muscle 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. doi: 10.1186/s41687-024-00712-0

Desai RJ, Wang SV, Sreedhara SK, Zabotka L, Khosrow-Khavar F, Nelson JC, Shi X, Toh S, Wyss R, Patorno E, Dutcher S, Li J, Lee H, Ball R, Dal Pan G, Segal JB, Suissa S, Rothman KJ, Greenland S, Hernan MA, Heagerty PJ, Schneeweiss S. Process guide for inferential studies using healthcare data from routine clinical practice to evaluate causal effects of drugs (PRINCIPLED): considerations from the FDA Sentinel Innovation Center. BMJ. 2024 Feb 12;384:e076460. doi: 10.1136/bmj-2023-076460

Davis S, Edwards T, Norcross L, Fehnel S, Beaudet A, Eckart M, Fastenau J. Use of the National Cancer Institute Patient-Reported Outcomes version of the common terminology criteria for adverse events to assess treatment tolerability in pulmonary arterial hypertension: qualitative patient research findings in current and former users of oral selexipag. J Patient Rep Outcomes. 2023 Dec 18;7(1):134. doi: 10.1186/s41687-023-00673-w.

Golden AH, Gabriel MH, Russo J, Price M, Ruhmel S, Nilsson A, Delong PS, Jelsma J, Carty M. Let's talk about it: an exploration of the comparative use of three different digital platforms to gather patient-reported outcome measures. J Patient Rep Outcomes. 2023 Dec 12;7(1):130. doi: 10.1186/s41687-023-00666-9

Williams V, Romano (DeMuro) C, Clark M, Korver D, Williams N, Goss D, Naujoks C, Marvel J. Psychometric evaluation of an electronic Asthma Symptom Diary for young children. J Patient Rep Outcomes. 2023 Oct 30;7(1):105. doi: 10.1186/s41687-023-00647-y

Martin S, Harris N, Romanus D. Evaluating meaningful changes in physical functioning and cognitive declines in metachromatic leukodystrophy: a caregiver interview study. J Patient Rep Outcomes. 2023 Jul 17;7(1):70. doi: 10.1186/s41687-023-00595-7

Twiss J, Whalley D, Doward L, Balp MM, Brass CA, Cryer D, Sanyal A, Anstee QM. Validation of NASH-CHECK: a novel patient-reported outcome measure for nonalcoholic steatohepatitis. J Patient Rep Outcomes. 2023 Jul 14;7(1):69. doi: 10.1186/s41687-023-00589-5

Osborne RH, Nelson L, Fehnel S, Williams N, Bender R, Ziemiecki R, Gymnopoulou E, De Paepe E, Vandendijck Y, Norcross L, Heijnen E, Ispas G, Comeaux C, Callendret B, Chan EKH, Scott JA. Evaluation of symptoms in respiratory syncytial virus infection in adults: psychometric evaluation of the respiratory infection intensity and impact questionnaire™ symptom scores. J Patient Rep Outcomes. 2023 Jun 1;7(1):51. doi: 10.1186/s41687-023-00593-9.

Chan EKH, Williams V, Romano C, Fehnel S, Slagle AF, Stoddard J, Sadoff J, Mayorga M, Lewis S, Yarr S, Ma J, Liu Y, Katz EG, McNulty P, van Dromme I, McQuarrie K. Psychometric evaluation of the symptoms of infection with coronavirus-19 (SIC): results from a cross-sectional study and a phase 3 clinical trial. J Patient Rep Outcomes. 2023 May 17;17(1):45. doi: 10.1186/s41687-023-00581-z

Martin S, Bender R, Krasner A, Marmon T, Monahan M, Nelson L. Development and evaluation of the acromegaly symptom diary. J Patient Rep Outcomes. 2023 Feb 15;7(1):15. doi: 10.1186/s41687-023-00541-7

DeMuro (Romano) C, Mayorga M, Ruiz-Guinazu J, Trudel GC, Fehnel S, McQuarrie K, Chan EKH, Katz EG. Development of patient- and observer-reported outcome measures to assess COVID-19 signs and symptoms in children and adolescents. J Patient Rep Outcomes. 2023 Jan 26;7(1):7. doi: 10.1186/s41687-023-00542-6

Skajaa N, Adelborg K, Horvath-Puho E, Rothman KJ, Henderson VW, Thygesen LC, Sorensen HT. Labour market participation and retirement after stroke in Denmark: registry based cohort study. BMJ. 2023 Jan 3;380:e072308. doi: 10.1136/bmj-2022-072308

Therrien F, Meehan SR, Weiss C, Dine J, Brown TM, MacKenzie EM. Exploring life engagement from the perspective of patients with major depressive disorder: a study using patient interviews. J Patient Rep Outcomes. 2022 Oct 12;6(1):111. doi: 10.1186/s41687-022-00517-z

Romano C, Fehnel S, Stoddard J, Sadoff J, Lewis S, McNulty P, Chan EKH, Evans E, Jamieson C, Slagle AF, Mangel A, McQuarrie K. Development of a novel patient‑reported outcome measure to assess signs and symptoms of COVID‑19. J Patient Rep Outcomes. 2022 Jul 29;6(1):85. doi: 10.1186/s41687-022-00471-w

Martin S, Shanchez RJ, Olayinka-Amao B, Harris C, Fehnel S. Qualitative interviews in patients with lipodystrophy to assess the patient experience: evaluation of hunger and other symptoms. J Patient Rep Outcomes. 2022 Jul 29.

Romano C, Harris N, Gnanasakthy A, D'Alessio D, Chandiwana D. Patient experiences with patient-reported outcome measures in metastatic breast cancer trials: qualitative interviews. J Patient Rep Outcomes. 2022 Jun 3;6(1):60. doi: 10.1186/s41687-022-00460-z

Clark M, Romano C, Olayinka-Amao O, Whalley D, Crawford R, Pathak P, Brindicci C, Garg K, Kordy K, Everhard F, Patalano F, Roesler Z, Sutton T, Goransson O, Landles R, Naujoks C, Marvel J, Keininger DL. Development and content validation of a self-completed, electronic Pediatric Asthma Symptom Diary. J Patient Rep Outcomes. 2022 Mar 20;6(1):25. doi: 10.1186/s41687-022-00432-3

Weiss C, Meehan SR, Brown TM, Gupta C, Morup MF, Thase ME, McIntyre RS, Ismail Z. Effects of adjunctive brexpiprazole on calmness and life engagement in major depressive disorder: post hoc analysis of patient-reported outcomes from clinical trial exit interviews. J Patient Rep Outcomes. 2021 Dec 11;5(1):128. doi: 10.1186/s41687-021-00380-4.

Dong OM, Roberts MC, Wu RR, Voils CI, Sperber N, Gavin KL, Bates J, Chanfreau-Coffinier C, Naglich M, Kelley MJ, Vassy JL, Sriram P, Heise CW, Rivas S, Ribeiro M, Chapman JG, Voora D. Evaluation of the veterans affairs pharmacogenomic testing for veterans (PHASER) clinical program at initial test sites. Pharmacogenomics. 2021 Nov 1;22(17):1121-33. doi: 10.2217/pgs-2021-0089

Darden C, Price M, Ray D, Goldstein G, Goss D, Bennett L, Garbinsky D, Thota R. Patients' satisfaction with long-acting injectable somatostatin analog therapy for neuroendocrine tumors. J Patient Rep Outcomes. 2021 Sep 7;5(1):82. doi: 10.1186/s41687-021-00355-5

Soler MJ, Ribera A, Marsal JR, Mendez AB, Andres M, Azancot MA, Oristrell G, Mendez-Boo L, Cohen J, Barrabes JA, Ferreira-Gonzalez I, Vall d’Hebron COVID-19 Working Group. Association of renin-angiotensin system blockers with COVID-19 diagnosis and prognosis in patients with hypertension: a population-based study. Clin Kidney J. 2021 Sep 3;15(1):79-94. doi: 10.1093/ckj/sfab161

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

English M, Stoykova B, Slota C, Doward L, Siddiqui E, Crawford R, DiBenedetti D. Qualitative study: burden of menopause-associated vasomotor symptoms (VMS) and validation of PROMIS sleep disturbance and sleep-related impairment measures for assessment of VMS impact on sleep. J Patient Rep Outcomes. 2021 Apr 26;5(1):37. doi: 10.1186/s41687-021-00289-y

Ackley SF, Zimmerman SC, Brenowitz WD, Tchetgen Tchetgen EJ, Gold AL, Manly JJ, Mayeda ER, Filshtein TJ, Power MC, Elahi FM, Brickman AM, Glymour MM. Effect of reductions in amyloid levels on cognitive change in randomized trials: instrumental variable meta-analysis. BMJ. 2021 Feb 25;372:n156. doi: 10.1136/bmj.n156

Dong OM, Bates J, Chanfreau-Coffinier C, Naglich M, Kelley MJ, Meyer LJ, Icardi M, Vassy JL, Sriram P, Heise CW, Rivas S, Ribeiro M, Jacobitz R, Rozelle S, Chapman JG, Voora D. Institutional profile: veterans affairs pharmacogenomic testing for veterans (PHASER) program. Pharmacogenomics. 2021 Jan 6;22(3):2020-0173. doi: 10.2217/pgs-2020-0173

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

Yland JJ, Bresnick KA, Hatch EE, Wesselink AK, Mikkelsen EM, Rothman KJ, Sorensen HT, Huybrechts KF, Wise LA. Pregravid contraceptive use and fecundability: prospective cohort study. BMJ. 2020 Nov 11;371:m3966. doi: 10.1136/bmj.m3966

DiBenedetti D, Soliman AM, Gupta C, Surrey ES. Patients' perspectives of endometriosis-related fatigue: qualitative interviews. J Patient Rep Outcomes. 2020 May 6;4(1):33. doi: 10.1186/s41687-020-00200-1

Nelson LM, DiBenedetti D, Pariser DM, Glaser DA, Hebert AA, Hofland H, Drew J, Ingolia D, Gillard KK, Fehnel S. Development and validation of the axillary sweating daily diary: a patient-reported outcome measure to assess axillary sweating severity. J Patient Rep Outcomes. 2019 Sep 5;3(1):59. doi: 10.1186/s41687-019-0148-8

Suzuki O, Dong OM, Howard RM, Wiltshire T. Characterizing the pharmacogenome using molecular inversion probes for targeted next-generation sequencing. Pharmacogenomics. 2019 Sep;20(14):1005-20. doi: 10.2217/pgs-2019-0057

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.

Harrington M, Hareendran A, Skalicky A, Wilson H, Clark M, Mikl J. Assessing the impact on caregivers caring for patients with rare pediatric lysosomal storage diseases: development of the Caregiver Impact Questionnaire. J Patient Rep Outcomes. 2019 Jul 23;3(1):44. doi: 10.1186/s41687-019-0140-3

Pajouheshnia R, Groenwold RHH, Peelen LM, Reitsma JB, Moons KGM. When and how to use data from randomised trials to develop or validate prognostic models. BMJ. 2019 May 29;356:I2154. doi: 10.1136/bmj.l2154

Lewis EF, Coles TM, Lewis S, Nelson LM, Barrett A, DeMuro Romano C, Stull DE, Turner SJ, Chang CG. Development, psychometric evaluation, and initial feasibility assessment of a symptom tracker for use by patients with heart failure (HFaST). J Patient Rep Outcomes. 2019 May 2;3(1):26. doi: 10.1186/s41687-019-0113-6

Camprodon-Rosanas E, Pujol J, Martínez-Vilavella G, Blanco-Hinojo L, Medrano-Martorell S, Batlle S, Forns J, Ribas-Fito N, Dolz M, Sunyer J. Brain structure and function in school-aged children with sluggish cognitive tempo symptoms. J Am Acad Child Adolesc Psychiatry. 2019 Feb;58(2):256-96. doi: 10.1016/j.jaac.2018.09.441

Lewis S, DeMuro C, Block SL, Senders S, Wisman P, Toback S, Chien JW, Williams V. Development of a novel observer-reported outcome measure for the assessment of Respiratory Syncytial Virus (RSV) infection symptoms in pediatric clinical trials. J Patient Rep Outcomes. 2018 Dec;2(9). doi: 10.1186/s41687-018-0034-9

Dong OM, Li A, Suzuki O, Oni-Orisan A, Gonzalez R, Stouffer GA, Lee CR, Wiltshire T. Projected impact of a multigene pharmacogenetic test to optimize medication prescribing in cardiovascular patients. Pharmacogenomics. 2018 Jun 1;19(9):771-82. doi: 10.2217/pgs-2018-0049

Obel N, Dessau RB, Krogfelt KA, Bodilsen J, Andersen NS, Moller JK, Roed C, Omland LH, Christiansen CB, Ellermann-Eriksen S, Bangsborg JM, Hansen K, Benfield TL, Rothman KJ, Sorensen HT, Andersen NS, Lebech AM. Long term survival, health, social functioning, and education in patients with European Lyme neuroborreliosis: nationwide population based cohort study. BMJ. 2018 May 30;361:k1998. doi: 10.1136/bmj.k1998

Wiltshire T, Dong OM. Clinical pharmacogenetics: how do we ensure a favorable future for patients? Pharmacogenomics. 2018 Apr;19(6):553-62. doi: 10.2217/pgs-2017-0192

Williams V, DeMuro C, Lewis S, Williams N, Wolynn T, Wisman P, Block SL, Senders S, Toback S, Chien JW. Psychometric evaluation of a caregiver diary for the assessment of symptoms of respiratory syncytial virus. J Patient Rep Outcomes. 2018;2(10). doi: 10.1186/s41687-018-0036-7

Borse MS, Dong OM, Polasek MJ, Farley JF, Stouffer GA, Lee CR. CYP2C19-guided antiplatelet therapy: a cost-effectiveness analysis of 30-day and 1-year outcomes following percutaneous coronary intervention. Pharmacogenomics. 2017 Aug;18(2):1155-66. doi: 10.2217/pgs-2017-0075

Brown TM, Martin S, Fehnel SE, Deal LS. Development of the impact of juvenile metachromatic leukodystrophy on physical activities scale. J Patient Rep Outcomes. 2017;2(1):15. doi: 10.1186/s41687-018-0041-x

Mikkelsen EM, Riis AH, Wise LA, Hatch EE, Rothman KJ, Cueto HT, Sørensen HT. Alcohol consumption and fecundability: prospective Danish cohort study. BMJ. 2016 Aug 31;354:i4262. doi: 10.1136/bmj.i4262

Rak EC, Hooper SR, Belsante MJ, Burnett O, Layton B, Tauer D, Mantoo B, DeWalt D, Ferris ME. Caregiver word reading literacy and health outcomes among children treated in a pediatric nephrology practice. Clin Kidney J. 2016 Jun;9(3):510-5. doi: 10.1093/ckj/sfw015

Warttig S, Ward S, Rogers G, Guideline Development Group. Diagnosis and management of gallstone disease: summary of NICE guidance. BMJ. 2014 Oct 30;349:g6241. doi: 10.1136/bmj.g6241

Martinez C, Assimes TL, Mines D, Dell'aniello S, Suissa S. Use of venlafaxine compared with other antidepressants and the risk of sudden cardiac death or near death: a nested case-control study. BMJ. 2010 Feb 5;340:c249. doi: 10.1136/bmj.c249

Starke JR, Mucci L, Rothman KJ, Adami HO. Screening for prostate cancer remains controversial. BMJ. 2009 Sep 24;339(7724):b3601.

Rubino A, Roskell NS, Tennis P, Mines D, Weich S, Andrews E. Risk of suicide during treatment with venlafaxine, citalopram, fluoxetine, and dothiepin: retrospective cohort study. BMJ. 2007 Feb 3;334(7587):242-5.

Rothman KJ, Evans S. More on JAMA's policy on industry sponsored studies. BMJ. 2006 Feb 25;332(7539):489.

Rothman KJ, Evans S. Extra scrutiny for industry funded trials. BMJ. 2005 Jan 1;331(7529):1350-1.