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Your search keyword '"Ben-Joseph, Rami"' showing total 237 results
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237 results on '"Ben-Joseph, Rami"'

2. Transferability of real-world data across borders for regulatory and health technology assessment decision-making

Author

Jaksa, Ashley, Arena, Patrick J, Chan, Kelvin KW, Ben-Joseph, Rami H, Jónsson, Páll, and Campbell, Ulka B

Subjects
Health Services and Systems, Health Sciences, Generic health relevance, Good Health and Well Being, transferability, real-world data, regulatory decision-making, health technology assessments, data relevance, Biomedical and clinical sciences, Health sciences
Abstract

Recently, there has been increased consideration of real-world data (RWD) and real-world evidence (RWE) in regulatory and health technology assessment (HTA) decision-making. Due to challenges in identifying high-quality and relevant RWD sources, researchers and regulatory/HTA bodies may turn to RWD generated in locales outside of the locale of interest (referred to as "transferring RWD"). We therefore performed a review of stakeholder guidance as well as selected case studies to identify themes for researchers to consider when transferring RWD from one jurisdiction to another. Our review highlighted that there is limited consensus on defining decision-grade, transferred RWD; certain stakeholders have issued relevant guidance, but the recommendations are high-level and additional effort is needed to generate comprehensive guidance. Additionally, the case studies revealed that RWD transferability has not been a consistent concern for regulatory/HTA bodies and that more focus has been put on the evaluation of internal validity. To help develop transferability best practices (alongside internal validity best practices), we suggest that researchers address the following considerations in their justification for transferring RWD: treatment pathways, nature of the healthcare system, incidence/prevalence of indication, and patient demographics. We also recommend that RWD transferability should garner more attention as the use of imported RWD could open doors to high-quality data sources and potentially reduce methodological issues that often arise in the use of local RWD; we thus hope this review provides a foundation for further dialogue around the suitability and utility of transferred RWD in the regulatory/HTA decision-making space.

Published
2022

5. Increased Risk of Hypertension Onset Among Patients With Narcolepsy Newly Treated With High-Sodium Oxybate (P5-13.002)

Author

Ben-Joseph, Rami, primary, Somers, Virend, additional, Black, Jed, additional, D’Agostino, Ralph, additional, Saad, Ragy, additional, Davis, Mat, additional, Macfadden, Wayne, additional, Mues, Katherine, additional, Jackson, Clark, additional, Ni, Weiyi, additional, Cook, Michael, additional, Pitino, Julia, additional, Latimer, Helen, additional, Dabrowski, Elizabeth, additional, and White, William, additional

Published
2023
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8. Efficacy of lurbinectedin in a clinical trial versus other standard of care in a real-world comparator arm in relapsed/refractory small cell lung cancer patients.

Author

Ganti, Apar Kishor, primary, Prince, Patricia, additional, Wang, Xue, additional, Estrin, Adina, additional, Boccuti, Anne, additional, Rengarajan, Badri, additional, Naveh, Navit, additional, D'Agostino Jr., Ralph, additional, Alvord, Trevor, additional, and Ben-Joseph, Rami, additional

Published
2022
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36. Predicting waist circumference from body mass index

Author

Bozeman Samuel R, Hoaglin David C, Burton Tanya M, Pashos Chris L, Ben-Joseph Rami H, and Hollenbeak Christopher S

Subjects
Medicine (General), R5-920
Abstract

Abstract Background Being overweight or obese increases risk for cardiometabolic disorders. Although both body mass index (BMI) and waist circumference (WC) measure the level of overweight and obesity, WC may be more important because of its closer relationship to total body fat. Because WC is typically not assessed in clinical practice, this study sought to develop and verify a model to predict WC from BMI and demographic data, and to use the predicted WC to assess cardiometabolic risk. Methods Data were obtained from the Third National Health and Nutrition Examination Survey (NHANES) and the Atherosclerosis Risk in Communities Study (ARIC). We developed linear regression models for men and women using NHANES data, fitting waist circumference as a function of BMI. For validation, those regressions were applied to ARIC data, assigning a predicted WC to each individual. We used the predicted WC to assess abdominal obesity and cardiometabolic risk. Results The model correctly classified 88.4% of NHANES subjects with respect to abdominal obesity. Median differences between actual and predicted WC were − 0.07 cm for men and 0.11 cm for women. In ARIC, the model closely estimated the observed WC (median difference: − 0.34 cm for men, +3.94 cm for women), correctly classifying 86.1% of ARIC subjects with respect to abdominal obesity and 91.5% to 99.5% as to cardiometabolic risk. The model is generalizable to Caucasian and African-American adult populations because it was constructed from data on a large, population-based sample of men and women in the United States, and then validated in a population with a larger representation of African-Americans. Conclusions The model accurately estimates WC and identifies cardiometabolic risk. It should be useful for health care practitioners and public health officials who wish to identify individuals and populations at risk for cardiometabolic disease when WC data are unavailable.

Published
2012
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49. Health-Care Resource Use by Asthmatics in Croatia Health-Care Resource Use by Asthmatics in Croatia

Author

Orešković, Stjepan, Božičević, Ivana, Mastilica, Miroslav, Bakran, Ivan, Grle-Popović, Sanja, and Ben-Joseph, Rami

Subjects
anti-asthmatic agents, asthma, observational study, patient survey, practice guidelines, socioeconomic factors
Abstract

We report a survey of the impact of asthma on daily life and on health-care resource use by adult asthma patients in four counties in Croatia. Over a 1-year period beginning November 1998, 185 general practitioners recruited 504 asthma patients, who completed a questionnaire about their drug therapy, health-care resource use, symptoms, limitations in daily activities, and work loss due to asthma. Over a 2-week period, inhaled corticosteroids were used by 51.5% of patients, short-acting and long-acting beta2-agonists by 70.8% and 53.5%, respectively, and oral extended-release theophyllines by 29.8%. Nocturnal awakenings were experienced by 58.7% of patients, 75.5% experienced daytime symptoms, and 42.5% were limited in their daily activities. In the previous year, 12.5% of the patients were hospitalized, 33% missed work, and 70% reported reduced effectiveness in the workplace. In the previous 6 months, 35.2% of the patients visited an emergency room due to worsening of asthma symptoms. The human and socioeconomic burden of asthma in Croatia is considerable. These results can help guide the development of asthma policy in Croatia and raise awareness of asthma as a public health issue.

Published
2002

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