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1,873 results on '"CAPPELLERI, Joseph C."'

3. Cross-Sectional Survey of Factors Contributing to COVID-19 Testing Hesitancy Among US Adults at Risk of Severe Outcomes from COVID-19

Author

Assaf, Annlouise R., Sidhu, Gurinder S., Soni, Apurv, Cappelleri, Joseph C., Draica, Florin, Herbert, Carly, Arham, Iqra, Bader, Mehnaz, Jimenez, Camille, Bois, Michael, Silvester, Eliza, Meservey, Jessica, Eng, Valerie, Nelson, Megan, Cai, Yong, Nangarlia, Aakansha, Tian, Zhiyi, Liu, Yanping, and Watt, Stephen

Published
2024
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8. Interpreting the Relationship Among Itch, Sleep, and Work Productivity in Patients with Moderate-to-Severe Atopic Dermatitis: A Post Hoc Analysis of JADE MONO-2

Author

Yosipovitch, Gil, Gooderham, Melinda J., Ständer, Sonja, Fonacier, Luz, Szepietowski, Jacek C., Deleuran, Mette, Girolomoni, Giampiero, Su, John C., Bushmakin, Andrew G., Cappelleri, Joseph C., Feeney, Claire, Chan, Gary, Thorpe, Andrew J., Valdez, Hernan, Biswas, Pinaki, Rojo, Ricardo, DiBonaventura, Marco, and Myers, Daniela E.

Published
2024
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11. Network Meta-Interpolation: Effect Modification Adjustment in Network Meta-Analysis Using Subgroup Analyses

Author

Harari, Ofir, Soltanifar, Mohsen, Cappelleri, Joseph C., Verhoek, Andre, Ouwens, Mario, Daly, Caitlin, and Heeg, Bart

Abstract

Effect modification (EM) may cause bias in network meta-analysis (NMA). Existing population adjustment NMA methods use individual patient data to adjust for EM but disregard available subgroup information from aggregated data in the evidence network. Additionally, these methods often rely on the shared effect modification (SEM) assumption. In this paper, we propose Network Meta-Interpolation (NMI): a method using subgroup analyses to adjust for EM that does not assume SEM. NMI balances effect modifiers across studies by turning treatment effect (TE) estimates at the subgroup- and study level into TE and standard errors at EM values common to all studies. In an extensive simulation study, we simulate two evidence networks consisting of four treatments, and assess the impact of departure from the SEM assumption, variable EM correlation across trials, trial sample size and network size. NMI was compared to standard NMA, network meta-regression (NMR) and Multilevel NMR (ML-NMR) in terms of estimation accuracy and credible interval (CrI) coverage. In the base case non-SEM dataset, NMI achieved the highest estimation accuracy with root mean squared error (RMSE) of 0.228, followed by standard NMA (0.241), ML-NMR (0.447) and NMR (0.541). In the SEM dataset, NMI was again the most accurate method with RMSE of 0.222, followed by ML-NMR (0.255). CrI coverage followed a similar pattern. NMI's dominance in terms of estimation accuracy and CrI coverage appeared to be consistent across all scenarios. NMI represents an effective option for NMA in the presence of study imbalance and available subgroup data.

Published
2023
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24. SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials.

Author

Calvert, Melanie, King, Madeleine, Mercieca-Bebber, Rebecca, Aiyegbusi, Olalekan, Kyte, Derek, Slade, Anita, Chan, An-Wen, Basch, E, Bell, Jill, Bennett, Antonia, Bhatnagar, Vishal, Blazeby, Jane, Bottomley, Andrew, Brown, Julia, Brundage, Michael, Campbell, Lisa, Cappelleri, Joseph C, Draper, Heather, Dueck, Amylou C, Ells, Carolyn, Frank, Lori, Golub, Robert M, Griebsch, Ingolf, Haywood, Kirstie, Hunn, Amanda, King-Kallimanis, Bellinda, Martin, Laura, Mitchell, Sandra, Morel, Thomas, Nelson, Linda, Norquist, Josephine, O'Connor, Daniel, Palmer, Michael, Patrick, Donald, Price, Gary, Regnault, Antoine, Retzer, Ameeta, Revicki, Dennis, Scott, Jane, Stephens, Richard, Turner, Grace, Valakas, Antonia, Velikova, Galina, von Hildebrand, Maria, Walker, Anita, and Wenzel, Lari

Subjects
Humans, Research Design, Quality of Life, Checklist, Research Report, Patient Reported Outcome Measures, clinical trials, education & training, protocols & guidelines, statistics & research methods, Clinical Sciences, Public Health and Health Services, Other Medical and Health Sciences
Abstract

Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients' symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health policy. Recent evidence suggests the PRO content of past trial protocols was often incomplete or unclear, leading to research waste. To address this issue, international, consensus-based, PRO-specific guidelines were developed: the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-PRO Extension. The SPIRIT-PRO Extension is a 16-item checklist which aims to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection to minimise research waste, and ultimately better inform patient-centred care. This SPIRIT-PRO explanation and elaboration (E&E) paper provides information to promote understanding and facilitate uptake of the recommended checklist items, including a comprehensive protocol template. For each SPIRIT-PRO item, we provide a detailed description, one or more examples from existing trial protocols and supporting empirical evidence of the item's importance. We recommend this paper and protocol template be used alongside the SPIRIT 2013 and SPIRIT-PRO Extension paper to optimise the transparent development and review of trial protocols with PROs.

Published
2021

26. Improvement in disease severity and pruritus outcomes with crisaborole ointment, 2%, by baseline atopic dermatitis severity in children and adolescents with mild‐to‐moderate atopic dermatitis

Author

Eichenfield, Lawrence F, Yosipovitch, Gil, Gold, Linda F Stein, Kalabis, Mizuho, Zang, Chuanbo, Vlahos, Bonnie, Sanders, Paul, Myers, Daniela E, Bushmakin, Andrew G, Cappelleri, Joseph C, Olivadoti, Melissa, and Paller, Amy S

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Pediatric, Adolescent, Boron Compounds, Bridged Bicyclo Compounds, Heterocyclic, Child, Child, Preschool, Dermatitis, Atopic, Double-Blind Method, Humans, Ointments, Pruritus, Severity of Illness Index, Treatment Outcome, atopic dermatitis, pruritus, therapy-topical, Paediatrics and Reproductive Medicine, Dermatology & Venereal Diseases, Clinical sciences, Paediatrics
Abstract

Background/objectivesCrisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate atopic dermatitis (AD). This pooled post hoc analysis of two phase 3 trials (NCT02118766, NCT02118792) assessed improvement and time to improvement in Investigator's Static Global Assessment (ISGA) and Severity of Pruritus Scale (SPS) outcomes in pediatric patients with mild-to-moderate AD.MethodsPatients aged ≥2 years were randomly assigned 2:1 to receive twice-daily crisaborole or vehicle for 28 days. Patients aged 2-17 years were pooled for this analysis. Proportions of patients and time to achieving ISGA success (clear [0] or almost clear [1] with ≥2-grade improvement from baseline), ISGA clear/almost clear, ≥1-grade improvement in ISGA, SPS success (SPS score ≤1 with ≥1-grade improvement), or ≥1-grade improvement in SPS score were analyzed and stratified by baseline ISGA.ResultsAt first postbaseline assessment (day 8), significantly higher proportions of crisaborole- than vehicle-treated patients achieved ISGA success, ISGA clear/almost clear, ≥1-grade ISGA improvement, SPS success, or ≥1-grade improvement in SPS regardless of baseline ISGA. Differences were significantly greater over time for all outcomes for patients with moderate baseline ISGA and numerically greater for those with mild baseline ISGA. Median times to ISGA and SPS outcomes were shorter for crisaborole versus vehicle.ConclusionImprovement in ISGA and SPS outcomes were observed with crisaborole in pediatric patients with mild-to-moderate baseline AD.

Published
2020

27. Single-arm studies involving patient-reported outcome data in oncology: a literature review on current practice

Author

Aiyegbusi, Olalekan Lee, Alanya, Ahu, Barbachano, Yolanda, Basch, Ethan, Calvert, Melanie, Campbell, Alicyn, Cappelleri, Joseph, Choi, Jungyeon, Cruz Rivera, Samantha, Delphin Amdal, Cecilie, Fiero, Mallorie, Goetghebeur, Els, Kamalakar, Rajesh, Keating, Karen, Kluetz, Paul, le Cessie, Saskia, Liu, Limin, Molenberghs, Geert, Musoro, Jammbe, Ness, David, Rantell, Khadija, Regnault, Antoine, Reijneveld, Jaap, Roychoudhury, Satrajit, Rumpold, Gerhard, Russell-Smith, Alexander, Rutherford, Claudia, Sail, Kavita, Sandin, Rickard, Sasseville, Maxime, Sauerbrei, Willi, Schiel, Anja, Schlichting, Michael, Soltys, Kathy, Sorum Falk, Ragnhild, Su, Yun, ten Seldam, Silene, Thomassen, Doranne, Van Lancker, Kelly, Musoro, Jammbe Z, Amdal, Cecilie Delphin, Cappelleri, Joseph C, Falk, Ragnhild Sørum, Fiero, Mallorie H, and Reijneveld, Jaap C

Published
2023
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28. Costs and Treatment Patterns Among Patients with Atopic Dermatitis Using Advanced Therapies in the United States: Analysis of a Retrospective Claims Database

Author

Eichenfield, Lawrence F, DiBonaventura, Marco, Xenakis, Jason, Lafeuille, Marie-Helene, Duh, Mei Sheng, Fakih, Iman, Levenberg, Mark, Cappelleri, Joseph C, and Sikirica, Vanja

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Atopic dermatitis, Corticosteroids, Costs, Dupilumab, Immunosuppressants, Phototherapy, Clinical sciences
Abstract

IntroductionFor many, atopic dermatitis (AD) is not adequately controlled with topical regimens. This analysis examined treatment using advanced therapies and associated costs.MethodsThe IQVIA Health Plan Claims data set was analyzed. Patients aged ≥ 12 years with AD who newly initiated advanced therapy after the availability of dupilumab (March 28, 2017) and had ≥ 6 months continuous enrollment before and after their first advanced therapy claim (index date) were included. Advanced therapies included dupilumab, systemic corticosteroids (SCSs), systemic immunosuppressants (SISs), and phototherapy. A multivariate regression model was used to predict annualized follow-up healthcare costs.ResultsIn total, 1980 patients were included (61.1% female; mean age, 41.2 years [SD, 17.4]; 11.3%

Published
2020

31. A latent class analysis of factors influencing preferences for infant respiratory syncytial virus (RSV) preventives among pregnant people in the United States

Author

Maculaitis, Martine C., primary, Hauber, Brett, additional, Beusterien, Kathleen M., additional, Will, Oliver, additional, Kopenhafer, Lewis, additional, Law, Amy W., additional, Vietri, Jeffrey T., additional, Cappelleri, Joseph C., additional, Coulter, Joshua R., additional, Pugh, Sarah, additional, and Shea, Kimberly M., additional

Published
2024
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