Perils of randomised controlled trial survival extrapolation assuming treatment effect waning: why the distinction between marginal and conditional estimates matters
A long-term, constant, protective treatment effect is a strong assumption when extrapolating survival beyond clinical trial follow-up, hence sensitivity to treatment effect waning is commonly assessed for economic evaluations. Forcing a HR (hazard ratio) to 1 does not necessarily estimate loss of individual-level treatment effect accurately due to HR selection bias. A simulation study was designed to explore the behaviour of marginal HRs under a waning conditional (individual-level) treatment effect and demonstrate bias in forcing a marginal HR to 1 when the estimand is ‘survival difference with individual-level waning�...
Source: Value in Health - December 25, 2023 Category: International Medicine & Public Health Authors: Angus C. Jennings, Mark J. Rutherford, Nicholas R. Latimer, Michael J. Sweeting, Paul C. Lambert Tags: Methodology Source Type: research
Modeling Thyroid Cancer Epidemiology in the United States Using Papillary Thyroid Carcinoma Microsimulation Model
Thyroid cancer incidence increased over 200% from 1992 to 2018, whereas mortality rates had not increased proportionately. The increased incidence has been attributed primarily to the detection of subclinical disease, raising important questions related to thyroid cancer control. We developed the Papillary Thyroid Carcinoma Microsimulation model (PATCAM) to answer them, including the impact of overdiagnosis on thyroid cancer incidence. (Source: Value in Health)
Source: Value in Health - December 21, 2023 Category: International Medicine & Public Health Authors: Oguzhan Alagoz, Yichi Zhang, Natalia Arroyo, Sara Fernandes-Taylor, Dou-Yan Yang, Craig Krebsbach, Manasa Venkatesh, Vivian Hsiao, Louise Davies, David O. Francis Tags: Methodology Source Type: research
Are manufacturing patents to blame for biosimilar market launch delays?
Biosimilar market launch delays are likely costing health care systems billions of dollars and preventing patients accessing affordable biologic therapies sooner. Many claim these delays are mostly caused by originator biologics ’ large patent portfolios asserted during litigation against biosimilar developers, particularly that the manufacturing patents filed after the originator is approved is an important driver of these delays. Our objective was to investigate the accuracy of these claims. (Source: Value in Health)
Source: Value in Health - December 21, 2023 Category: International Medicine & Public Health Authors: Rhys Williamson, Trent Munro, Avril Robertson, Lisette Pregelj, David Ascher Source Type: research
Benefit-harm analysis for informed decision making on participating in colorectal cancer screening: a modelling study
To facilitate informed decision making on participating in colorectal cancer (CRC) screening, we assessed the benefit-harm balance of CRC screening for a wide range of subgroups over different time horizons. (Source: Value in Health)
Source: Value in Health - December 21, 2023 Category: International Medicine & Public Health Authors: Henock G. Yebyo, Francine van Wifferen, Linda P.M. Pluymen, Mariska M.G. Leeflang, Evelien Dekker, Veerle M.H. Coup é, Milo A. Puhan, Marjolein J.E. Greuter, Inge Stegeman Source Type: research
Modeling Thyroid Cancer Epidemiology in the US using Papillary Thyroid Carcinoma Microsimulation model (PATCAM)
Thyroid cancer incidence increased over 200% from 1992 to 2018, while mortality rates had not increased proportionately. The increased incidence has been attributed primarily to the detection of subclinical disease, raising important questions related to thyroid cancer control. We developed the Papillary Thyroid Carcinoma Microsimulation model (PATCAM) to answer them including the impact of overdiagnosis on thyroid cancer incidence. (Source: Value in Health)
Source: Value in Health - December 21, 2023 Category: International Medicine & Public Health Authors: Oguzhan Alagoz, Yichi Zhang, Natalia Arroyo, Sara Fernandes-Taylor, Dou-Yan Yang, Craig Krebsbach, Manasa Venkatesh, Vivian Hsiao, Louise Davies, David O. Francis Tags: Methodology Source Type: research
Unanchored Population-Adjusted Indirect Comparison Methods for Time-to-Event Outcomes Using Inverse Odds Weighting, Regression Adjustment, and Doubly Robust Methods With Either Individual Patient or Aggregate Data
This study provides an overview and comparison of methods using a case study to increase familiarity. A recent method is applied to marginalize conditional hazard ratios, which allows for the comparisons of methods, and a doubly robust method is proposed. (Source: Value in Health)
Source: Value in Health - December 20, 2023 Category: International Medicine & Public Health Authors: Julie E. Park, Harlan Campbell, Kevin Towle, Yong Yuan, Jeroen P. Jansen, David Phillippo, Shannon Cope Tags: Comparative-Effectiveness Research/HTA Source Type: research
Emulating Trials and Quantifying Bias: The Convergence of Health Technology Assessment Agency Real-World Evidence Guidance
We read with interest the article by Moler-Zapata et al,1 illustrating how the target trial framework2 can be applied to a health technology assessment (HTA) setting with a demonstration study evaluating the cost-effectiveness of emergency surgery for 2 common acute gastrointestinal conditions. The article is of significant interest, given the real- world evidence (RWE) frameworks or guidance recently published by a number of HTA agencies, for example, the National Institute for Health and Care Excellence (NICE),3 Haute Autorité de santé (HAS),4,5 and the Canadian Agency for Drugs and Technologies in Health (CADTH),6 a...
Source: Value in Health - December 20, 2023 Category: International Medicine & Public Health Authors: Simon Chen, Natalie Tikhonovsky, Nishit Dhanji, Sreeram Ramagopalan Tags: Letter to the Editor Source Type: research
Letter to the Editor: Emulating trails and quantifying bias: the convergence of HTA agency RWE guidances
(Source: Value in Health)
Source: Value in Health - December 20, 2023 Category: International Medicine & Public Health Authors: Simon Chen, Natalie Tikhonovsky, Nishit Dhanji, Sreeram Ramagopalan Tags: Letter to the Editor Source Type: research
Unanchored population-adjusted indirect comparison methods for time-to-event outcomes using regression adjustment, inverse odds weighting, and doubly robust methods with either individual patient or aggregate data
Several methods for unanchored population-adjusted indirect comparisons (PAIC) are available. Exploring alternative adjustment methods, depending on the individual patient data (IPD) available and the aggregate data (AD) in the external study, may help minimize bias in unanchored indirect comparisons. However, methods for time-to-event outcomes are not well understood. We provide an overview and comparison of methods using a case study to increase familiarity. We apply a recent method to marginalize conditional hazard ratios, which allows for the comparisons of methods, and we propose a doubly robust method. (Source: Value in Health)
Source: Value in Health - December 20, 2023 Category: International Medicine & Public Health Authors: Julie E. Park, Harlan Campbell, Kevin Towle, Yong Yuan, Jeroen P. Jansen, David Phillippo, Shannon Cope Source Type: research
Work Productivity Among Younger Breast Cancer Survivors: The Impact of Behavioral Interventions for Depression
The Pathways to Wellness randomized controlled trial found that two behavioral interventions, mindfulness awareness practices and survivorship education, reduced depressive symptoms in younger breast cancer survivors (BCS) compared to wait-list control. This secondary analysis examines whether the interventions led to reduced loss of work productivity among younger BCS and whether such reductions were mediated by reductions in depressive symptoms. (Source: Value in Health)
Source: Value in Health - December 20, 2023 Category: International Medicine & Public Health Authors: Catherine M. Crespi, Patricia A. Ganz, Ann H. Partridge, Antonio Wolff, Hadine Joffe, Michael R. Irwin, Katie Thure, Laura Petersen, Ya-Chen Tina Shih, Julienne E. Bower Source Type: research
Scoring the value assessment framework for China: a factorial survey
To develop the scoring functions for the recently developed value assessment framework (VAF) for China which comprises 12 attributes. (Source: Value in Health)
Source: Value in Health - December 19, 2023 Category: International Medicine & Public Health Authors: Mengmeng Zhang, Yi Yang, Yun Bao, Melissa Kimber, Mitchell Levine, Feng Xie Source Type: research
Author Reply
We are grateful to the authors for their letter about our article on emulation of target trials (TTs) with real-world data to inform health technology assessment (HTA).1 We offer the following response and encourage further debate around this important topic. (Source: Value in Health)
Source: Value in Health - December 18, 2023 Category: International Medicine & Public Health Authors: Silvia Moler-Zapata, Andrew Hutchings, Stephen O ’Neill, Richard J. Silverwood, Richard Grieve Tags: Letter to the Editor Source Type: research
Author Reply: “Emulating Trials and Quantifying Bias: The Convergence of HTA Agency RWE Guidances”
We are grateful to the authors for their letter about our article on emulation of target trials (TTs) with real-world data to inform health technology assessment (HTA).1 We offer the following response and encourage further debate around this important topic. (Source: Value in Health)
Source: Value in Health - December 18, 2023 Category: International Medicine & Public Health Authors: Silvia Moler-Zapata, Andrew Hutchings, Stephen O ’Neill, Richard J. Silverwood, Richard Grieve Tags: Letter to the Editor Source Type: research
Author ’s reply: “Emulating trials and quantifying bias: the convergence of HTA agency RWE guidances”
(Source: Value in Health)
Source: Value in Health - December 18, 2023 Category: International Medicine & Public Health Authors: Silvia Moler-Zapata, Andrew Hutchings, Stephen O ’Neill, Richard J. Silverwood, Richard Grieve Tags: Letter to the Editor Source Type: research
Influence of Self-Reported Health Impairments on German EQ-5D-5L Values
Value Health. 2023;26(11):1636 –1644. (Source: Value in Health)
Source: Value in Health - December 18, 2023 Category: International Medicine & Public Health Authors: Svenja Elkenkamp, Kristina Ludwig, Wolfgang Greiner Tags: Erratum Source Type: research
