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3. Issues in Implementing Regression Calibration Analyses

Author

Boe, Lillian, Shaw, Pamela A., Midthune, Douglas, Gustafson, Paul, Kipnis, Victor, Park, Eunyoung, Sotres-Alvarez, Daniela, and Freedman, Laurence

Subjects
Statistics - Methodology
Abstract

Regression calibration is a popular approach for correcting biases in estimated regression parameters when exposure variables are measured with error. This approach involves building a calibration equation to estimate the value of the unknown true exposure given the error-prone measurement and other confounding covariates. The estimated, or calibrated, exposure is then substituted for the true exposure in the health outcome regression model. When used properly, regression calibration can greatly reduce the bias induced by exposure measurement error. Here, we first provide an overview of the statistical framework for regression calibration, specifically discussing how a special type of error, called Berkson error, arises in the estimated exposure. We then present practical issues to consider when applying regression calibration, including: (1) how to develop the calibration equation and which covariates to include; (2) valid ways to calculate standard errors (SE) of estimated regression coefficients; and (3) problems arising if one of the covariates in the calibration model is a mediator of the relationship between the exposure and outcome. Throughout the paper, we provide illustrative examples using data from the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) and simulations. We conclude with recommendations for how to perform regression calibration.

Published
2022

5. Celiac plexus radiosurgery for pain management in advanced cancer: a multicentre, single-arm, phase 2 trial

Author

Lawrence, Yaacov R, Miszczyk, Marcin, Dawson, Laura A, Diaz Pardo, Dayssy Alexandra, Aguiar, Artur, Limon, Dror, Pfeffer, Raphael M, Buckstein, Michael, Barry, Aisling S, Meron, Tikva, Dicker, Adam P, Wydmański, Jerzy, Zimmermann, Camilla, Margalit, Ofer, Hausner, David, Morag, Ofir, Golan, Talia, Jacobson, Galia, Dubinski, Sergey, Stanescu, Teo, Fluss, Ronen, Freedman, Laurence S, Ben-Ayun, Maoz, and Symon, Zvi

Published
2024
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10. DOJ Files False Claims Act Suit Against Public Health System Alleging Widespread Stark Law Violations For Excessive Physician Compensation

Author

Freedman, Laurence

Subjects
United States. Department of Justice -- Cases, Medical fees -- Cases, Health care industry -- Cases, Whistle blowing -- Cases, Health care industry, Company legal issue, Business, international, Medicare Catastrophic Coverage Repeal Act of 1989, False Claims Act
Abstract

The Department of Justice (DOJ) recently filed a complaint against Erlanger Health System (Erlanger), a county-owned public health system, and two of its Tennessee hospitals alleging that the health system [...]

Published
2024

13. Safety and efficacy of VB-111, an anticancer gene therapy, in patients with recurrent glioblastoma: results of a phase I/II study

Author

Brenner, Andrew J, Peters, Katherine B, Vredenburgh, James, Bokstein, Felix, Blumenthal, Deborah T, Yust-Katz, Shlomit, Peretz, Idit, Oberman, Bernice, Freedman, Laurence S, Ellingson, Benjamin M, Cloughesy, Timothy F, Sher, Naamit, Cohen, Yael C, Lowenton-Spier, Noa, Minei, Tamar Rachmilewitz, Yakov, Niva, Mendel, Itzhak, Breitbart, Eyal, and Wen, Patrick Y

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Brain Disorders, Orphan Drug, Cancer, Rare Diseases, Clinical Research, 6.1 Pharmaceuticals, 6.2 Cellular and gene therapies, Evaluation of treatments and therapeutic interventions, Antineoplastic Combined Chemotherapy Protocols, Bevacizumab, Brain Neoplasms, Genetic Therapy, Glioblastoma, Humans, Progression-Free Survival, anti-angiogenesis, gene therapy, glioblastoma, VB-111, viral immuno-oncology, VB-111, glioblastoma, Neurosciences, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundVB-111 is a non-replicating adenovirus carrying a Fas-chimera transgene, leading to targeted apoptosis of tumor vascular endothelium and induction of a tumor-specific immune response. This phase I/II study evaluated the safety, tolerability, and efficacy of VB-111 with and without bevacizumab in recurrent glioblastoma (rGBM).MethodsPatients with rGBM (n = 72) received VB-111 in 4 treatment groups: subtherapeutic (VB-111 dose escalation), limited exposure (LE; VB-111 monotherapy until progression), primed combination (VB-111 monotherapy continued upon progression with combination of bevacizumab), and unprimed combination (upfront combination of VB-111 and bevacizumab). The primary endpoint was median overall survival (OS). Secondary endpoints were safety, overall response rate, and progression-free survival (PFS).ResultsVB-111 was well tolerated. The most common adverse event was transient mild-moderate fever. Median OS time was significantly longer in the primed combination group compared with both LE (414 vs 223 days; hazard ratio [HR], 0.48; P = 0.043) and unprimed combination (414 vs 141.5 days; HR, 0.24; P = 0.0056). Patients in the combination phase of the primed combination group had a median PFS time of 90 days compared with 60 in the LE group (HR, 0.36; P = 0.032), and 63 in the unprimed combination group (P = 0.72). Radiographic responders to VB-111 exhibited characteristic, expansive areas of necrosis in the areas of initial enhancing disease.ConclusionsPatients with rGBM who were primed with VB-111 monotherapy that continued after progression with the addition of bevacizumab showed significant survival and PFS advantage, as well as specific imaging characteristics related to VB-111 mechanism of action. These results warrant further assessment in a randomized controlled study.

Published
2020

14. A randomized controlled phase III study of VB-111 combined with bevacizumab vs bevacizumab monotherapy in patients with recurrent glioblastoma (GLOBE)

Author

Cloughesy, Timothy F, Brenner, Andrew, de Groot, John F, Butowski, Nicholas A, Zach, Leor, Campian, Jian L, Ellingson, Benjamin M, Freedman, Laurence S, Cohen, Yael C, Lowenton-Spier, Noa, Minei, Tamar Rachmilewitz, Shmueli, Shifra Fain, Avgeropoulos, Nicholas, Beck, Joseph, Benkers, Tara, Bokstein, Felix, Burton, Eric, Butowski, Nicholas, Campian, Jian, Carrillo, Jose, Cloughesy, Timothy, de Groot, John, De Robles, Paula, Drappatz, Jan, Dunbar, Irine, Fink, Karen, Groves, Morris, Han, Xiaosi, Adila, Hormigo, Jensen, Randy, Kowalska, Agnieszka, Kumthekar, Pyriya, Lee, Mijung, Lesser, Glenn, Lossos, Alexander, Lukas, Rimas, Macdonald, David, Mammoser, Aaron, Mechtler, Laszlo, Mohile, Nimish, Nagpal, Seema, Nicholas, Garth, Kreisl, Teri, Pan, Edward, Peak, Scott, Pearlman, Michael, Perry, James, Peterson, Richard, Piccioni, David, Robins, Henry, Ronan, Lara, Salacz, Michael, Schiff, David, Tran, David, Tzuk-Shina, Tzahala, Walbert, Tobias, Wen, Patrick, Youst, Shlomit, and Y, Wen Patrick

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Brain Disorders, Neurosciences, Brain Cancer, Cancer, Rare Diseases, Clinical Research, Clinical Trials and Supportive Activities, 6.2 Cellular and gene therapies, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Angiogenesis Inhibitors, Antineoplastic Combined Chemotherapy Protocols, Bevacizumab, Brain Neoplasms, Glioblastoma, Humans, Progression-Free Survival, Treatment Outcome, anti-angiogenesis, gene therapy, glioblastoma VB-111, viral immuno-oncology, GLOBE Study Investigators, VB-111, glioblastoma, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundOfranergene obadenovec (VB-111) is an anticancer viral therapy that demonstrated in a phase II study a survival benefit for patients with recurrent glioblastoma (rGBM) who were primed with VB-111 monotherapy that was continued after progression with concomitant bevacizumab.MethodsThis pivotal phase III randomized, controlled trial compared the efficacy and safety of upfront combination of VB-111 and bevacizumab versus bevacizumab monotherapy. Patients were randomized 1:1 to receive VB-111 1013 viral particles every 8 weeks in combination with bevacizumab 10 mg/kg every 2 weeks (combination arm) or bevacizumab monotherapy (control arm). The primary endpoint was overall survival (OS), and secondary endpoints were objective response rate (ORR) by Response Assessment in Neuro-Oncology (RANO) criteria and progression-free survival (PFS).ResultsEnrolled were 256 patients at 57 sites. Median exposure to VB-111 was 4 months. The study did not meet its primary or secondary goals. Median OS was 6.8 versus 7.9 months in the combination versus control arm (hazard ratio, 1.20; 95% CI: 0.91-1.59; P = 0.19) and ORR was 27.3% versus 21.9% (P = 0.26). A higher rate of grades 3-5 adverse events was reported in the combination arm (67% vs 40%), mainly attributed to a higher rate of CNS and flu-like/fever events. Trends for improved survival with combination treatment were seen in the subgroup of patients with smaller tumors and in patients who had a posttreatment febrile reaction.ConclusionsIn this study, upfront concomitant administration of VB-111 and bevacizumab failed to improve outcomes in rGBM. Change of treatment regimen, with the lack of VB-111 monotherapy priming, may explain the differences from the favorable phase II results.Clinical trials registrationNCT02511405.

Published
2020

15. Safety and efficacy of VB-111, an anti-cancer gene-therapy, in patients with recurrent glioblastoma: results of a phase I/II study

Author

Brenner, Andrew J, Peters, Katherine B, Vredenburgh, James, Bokstein, Felix, Blumenthal, Deborah T, Yust-Katz, Shlomit, Peretz, Idit, Oberman, Bernice, Freedman, Laurence S, Ellingson, Benjamin M, Cloughesy, Timothy F, Sher, Naamit, Cohen, Yael C, Lowenton-Spier, Noa, Minei, Tamar Rachmilewitz, Yakov, Niva, Mendel, Itzhak, Breitbart, Eyal, and Wen, Patrick Y

Subjects
Cancer, Clinical Research, Rare Diseases, Orphan Drug, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, 6.2 Cellular and gene therapies, Antineoplastic Combined Chemotherapy Protocols, Bevacizumab, Brain Neoplasms, Genetic Therapy, Glioblastoma, Humans, Progression-Free Survival, anti-angiogenesis, gene therapy, glioblastoma, VB-111, viral immuno-oncology, VB-111, glioblastoma, Neurosciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

BackgroundVB-111 is a non-replicating adenovirus carrying a Fas-chimera transgene, leading to targeted apoptosis of tumor vascular endothelium and induction of a tumor-specific immune response. This phase I/II study evaluated the safety, tolerability, and efficacy of VB-111 with and without bevacizumab in recurrent glioblastoma (rGBM).MethodsPatients with rGBM (n = 72) received VB-111 in 4 treatment groups: subtherapeutic (VB-111 dose escalation), limited exposure (LE; VB-111 monotherapy until progression), primed combination (VB-111 monotherapy continued upon progression with combination of bevacizumab), and unprimed combination (upfront combination of VB-111 and bevacizumab). The primary endpoint was median overall survival (OS). Secondary endpoints were safety, overall response rate, and progression-free survival (PFS).ResultsVB-111 was well tolerated. The most common adverse event was transient mild-moderate fever. Median OS time was significantly longer in the primed combination group compared with both LE (414 vs 223 days; hazard ratio [HR], 0.48; P = 0.043) and unprimed combination (414 vs 141.5 days; HR, 0.24; P = 0.0056). Patients in the combination phase of the primed combination group had a median PFS time of 90 days compared with 60 in the LE group (HR, 0.36; P = 0.032), and 63 in the unprimed combination group (P = 0.72). Radiographic responders to VB-111 exhibited characteristic, expansive areas of necrosis in the areas of initial enhancing disease.ConclusionsPatients with rGBM who were primed with VB-111 monotherapy that continued after progression with the addition of bevacizumab showed significant survival and PFS advantage, as well as specific imaging characteristics related to VB-111 mechanism of action. These results warrant further assessment in a randomized controlled study.

Published
2020

19. Epidemiologic analyses with error-prone exposures: Review of current practice and recommendations

Author

Shaw, Pamela A., Deffner, Veronika, Keogh, Ruth H., Tooze, Janet A., Dodd, Kevin W., Küchenhoff, Helmut, Kipnis, Victor, and Freedman, Laurence S.

Subjects
Statistics - Applications
Abstract

Background: Variables in epidemiological observational studies are commonly subject to measurement error and misclassification, but the impact of such errors is frequently not appreciated or ignored. As part of the STRengthening Analytical Thinking for Observational Studies (STRATOS) Initiative, a Task Group on measurement error and misclassification (TG4) seeks to describe the scope of this problem and the analysis methods currently in use to address measurement error. Methods: TG4 conducted a literature survey of four types of research studies that are typically impacted by exposure measurement error: 1) dietary intake cohort studies, 2) dietary intake population surveys, 3) physical activity cohort studies, and 4) air pollution cohort studies. The survey was conducted to understand current practice for acknowledging and addressing measurement error. Results: The survey revealed that while researchers were generally aware that measurement error affected their studies, very few adjusted their analysis for the error. Most articles provided incomplete discussion of the potential effects of measurement error on their results. Regression calibration was the most widely used method of adjustment. Conclusions: Even in areas of epidemiology where measurement error is a known problem, the dominant current practice is to ignore errors in analyses. Methods to correct for measurement error are available but require additional data to inform the error structure. There is a great need to incorporate such data collection within study designs and improve the analytical approach. Increased efforts by investigators, editors and reviewers are also needed to improve presentation of research when data are subject to error., Comment: 41 pages, including 4 tables and supplementary material

Published
2018
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25. Utilizing an interim futility analysis of the OVAL study (VB-111-701/GOG 3018) for potential reduction of risk: A phase III, double blind, randomized controlled trial of ofranergene obadenovec (VB-111) and weekly paclitaxel in patients with platinum resistant ovarian cancer

Author

Arend, Rebecca C., Monk, Bradley J., Herzog, Thomas J., Moore, Kathleen N., Shapira-Frommer, Ronnie, Ledermann, Jonathan A., Tewari, Krishnansu S., Secord, Angeles Alvarez, Rachmilewitz Minei, Tamar, Freedman, Laurence S., Miller, Austin, Shmueli, Shifra Fain, Lavi, Michal, and Penson, Richard T.

Published
2021
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26. Multi-center nationwide comparison of seven serology assays reveals a SARS-CoV-2 non-responding seronegative subpopulation

Author

Oved, Kfir, Olmer, Liraz, Shemer-Avni, Yonat, Wolf, Tamar, Supino-Rosin, Lia, Prajgrod, George, Shenhar, Yotam, Payorsky, Irina, Cohen, Yuval, Kohn, Yishai, Indenbaum, Victoria, Lazar, Rachel, Geylis, Valeria, Oikawa, Michal Tepperberg, Shinar, Eilat, Stoyanov, Evgeniy, Keinan-Boker, Lital, Bassal, Ravit, Reicher, Shay, Yishai, Ruti, Bar-Chaim, Adina, Doolman, Ram, Reiter, Yoram, Mendelson, Ella, Livneh, Zvi, Freedman, Laurence S., and Lustig, Yaniv

Published
2020
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29. A new multivariate measurement error model with zero-inflated dietary data, and its application to dietary assessment

Author

Zhang, Saijuan, Carroll, Raymond J., Midthune, Douglas, Guenther, Patricia M., Krebs-Smith, Susan M., Kipnis, Victor, Dodd, Kevin W., Buckman, Dennis W., Tooze, Janet A., and Freedman, Laurence

Subjects
Statistics - Applications
Abstract

In the United States the preferred method of obtaining dietary intake data is the 24-hour dietary recall, yet the measure of most interest is usual or long-term average daily intake, which is impossible to measure. Thus, usual dietary intake is assessed with considerable measurement error. Also, diet represents numerous foods, nutrients and other components, each of which have distinctive attributes. Sometimes, it is useful to examine intake of these components separately, but increasingly nutritionists are interested in exploring them collectively to capture overall dietary patterns. Consumption of these components varies widely: some are consumed daily by almost everyone on every day, while others are episodically consumed so that 24-hour recall data are zero-inflated. In addition, they are often correlated with each other. Finally, it is often preferable to analyze the amount of a dietary component relative to the amount of energy (calories) in a diet because dietary recommendations often vary with energy level. The quest to understand overall dietary patterns of usual intake has to this point reached a standstill. There are no statistical methods or models available to model such complex multivariate data with its measurement error and zero inflation. This paper proposes the first such model, and it proposes the first workable solution to fit such a model. After describing the model, we use survey-weighted MCMC computations to fit the model, with uncertainty estimation coming from balanced repeated replication., Comment: Published in at http://dx.doi.org/10.1214/10-AOAS446 the Annals of Applied Statistics (http://www.imstat.org/aoas/) by the Institute of Mathematical Statistics (http://www.imstat.org)

Published
2011
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41. Cohort-Controlled Comparison of Umbilical Cord Blood Transplantation Using Carlecortemcel-L, a Single Progenitor–Enriched Cord Blood, to Double Cord Blood Unit Transplantation

Author

Stiff, Patrick J., Montesinos, Pau, Peled, Tony, Landau, Efrat, Goudsmid, Noga Rosenheimer, Mandel, Julie, Hasson, Nira, Olesinski, Esti, Glukhman, Ela, Snyder, David A., Cohen, Einat Galamidi, Kidron, Orna Srur, Bracha, Dalia, Harati, Dorit, Ben-Abu, Keren, Freind, Etty, Freedman, Laurence S., Cohen, Yael C., Olmer, Liraz, Barishev, Raya, Rocha, Vanderson, Gluckman, Eliane, Horowitz, Mary M., Eapen, Mary, Nagler, Arnon, and Sanz, Guillermo

Published
2018
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43. Report of the Editors: 2005

Author

Freedman, Laurence, Kenward, Mike, Lin, Xihong, Wang, Naisyin, and Davidian, Marie

Published
2006

49. Factors Associated With Protection From SARS-CoV-2 Omicron Variant Infection and Disease Among Vaccinated Health Care Workers in Israel

Author

Gilboa, Mayan, primary, Gonen, Tal, additional, Barda, Noam, additional, Cohn, Shelly, additional, Indenbaum, Victoria, additional, Weiss-Ottolenghi, Yael, additional, Amit, Sharon, additional, Asraf, Keren, additional, Joseph, Gili, additional, Levin, Tal, additional, Kanaaneh, Yara, additional, Aydenzon, Alex, additional, Canetti, Michal, additional, Freedman, Laurence, additional, Zuckerman, Neta, additional, Mendelson, Ella, additional, Doolman, Ram, additional, Kreiss, Yitshak, additional, Regev-Yochay, Gili, additional, and Lustig, Yaniv, additional

Published
2023
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