Physical and mental health outcomes of COVID-19 induced delay in oncological care: A systematic review

BackgroundDuring the COVID-19 pandemic cancer patients might have experienced delays in screening, diagnosis and/or treatment. A systematic review was conducted to give an overview of the effects of COVID-19 induced delays in oncological care on the physical and mental health outcomes of cancer patients.MethodsMEDLINE and EMBASE databases were searched for articles on the effects of COVID-19 induced delays on physical and mental health outcomes.ResultsOut of 1333 papers, eighteen observational, and twelve modelling studies were included. In approximately half of the studies, tumor stage distribution differed during the pandemic compared to before the pandemic. Modelling studies predicted that the estimated increase in the number of deaths ranged from -0.04 to 30%, and the estimated reduction in survival ranged from 0.4 to 35%. Varying results on the impact on mental health, e.g. anxiety and depression, were seen.ConclusionsDue to large methodological discrepancies between the studies and the varying results, the effect of COVID-19 induced delays on the physical and mental health outcomes of cancer patients remains uncertain. While modelling studies estimated an increase in mortality, observational studies suggest that mortality might not increase to a large extent. More longitudinal observational data from the pandemic period is needed for more conclusive results

Linking the regulatory and reimbursement processes for medical devices: the need for integrated assessments

Much criticism has been directed at the licensing requirements for medical devices (MDs) as they often result in a lack of robust evidence to inform health technology assessment (HTA) decisions. To better understand the current international decisional framework on MD technologies, we undertook three linked research studies: a review of the device regulatory procedures; a survey of current HTA practices; and an empirical comparison of HTA reports of drugs versus MDs. Our review confirms current device regulatory processes across the globe are substantially less stringent than drugs. As a result, international HTA agencies report that they face a number of challenges when assessing MDs, including reliance on sub-optimal data to make clinical and cost-effectiveness decisions. Whilst many HTA agencies have adapted their processes and procedures to handle MD technologies submissions, in our comparison of HTA reports we found little evidence of the application of methodologies that take account of device-specific issues, such as incremental development. Overall, our research reinforces the need for better linkage between licensing and HTA and the development and application of innovative HTA methodologies with the objective of securing faster patient access for those technologies that can be shown to represent good value for money

Linking the Regulatory and Reimbursement Processes for Medical Devices : The Need for Integrated Assessments

Much criticism has been directed at the licencing requirements for medical devices (MDs) as they often result in a lack of robust evidence to inform health technology assessment (HTA) decisions. To better understand the current international decisional framework on MD technologies, we undertook three linked research studies: a review of the device regulatory procedures, a survey of current HTA practices and an empirical comparison of HTA reports of drugs versus MDs. Our review confirms that current device regulatory processes across the globe are substantially less stringent than drugs. As a result, international HTA agencies report that they face a number of challenges when assessing MDs, including reliance on suboptimal data to make clinical and cost-effectiveness decisions. Whilst many HTA agencies have adapted their processes and procedures to handle MD technology submissions, in our comparison of HTA reports we found little evidence of the application of methodologies that take account of device-specific issues, such as incremental development. Overall, our research reinforces the need for better linkage between licencing and HTA and the development and application of innovative HTA methodologies with the objective of securing faster patient access for those technologies that can be shown to represent good value for money

Prediction of complications in health economic models of type 2 diabetes: a review of methods used.

AimDiabetes health economic (HE) models play important roles in decision making. For most HE models of diabetes 2 diabetes (T2D), the core model concerns the prediction of complications. However, reviews of HE models pay little attention to the incorporation of prediction models. The objective of the current review is to investigate how prediction models have been incorporated into HE models of T2D and to identify challenges and possible solutions.MethodsPubMed, Web of Science, Embase, and Cochrane were searched from January 1, 1997, to November 15, 2022, to identify published HE models for T2D. All models that participated in The Mount Hood Diabetes Simulation Modeling Database or previous challenges were manually searched. Data extraction was performed by two independent authors. Characteristics of HE models, their underlying prediction models, and methods of incorporating prediction models were investigated.ResultsThe scoping review identified 34 HE models, including a continuous-time object-oriented model (n = 1), discrete-time state transition models (n = 18), and discrete-time discrete event simulation models (n = 15). Published prediction models were often applied to simulate complication risks, such as the UKPDS (n = 20), Framingham (n = 7), BRAVO (n = 2), NDR (n = 2), and RECODe (n = 2). Four methods were identified to combine interdependent prediction models for different complications, including random order evaluation (n = 12), simultaneous evaluation (n = 4), the ‘sunflower method’ (n = 3), and pre-defined order (n = 1). The remaining studies did not consider interdependency or reported unclearly.ConclusionsThe methodology of integrating prediction models in HE models requires further attention, especially regarding how prediction models are selected, adjusted, and ordered

Budget impact analysis of a combined lifestyle intervention: Estimate of budget impact for health insurers

A combined lifestyle intervention (Dutch abbreviation GLI) is a treatment for people with (a) obesity (BMI 303-35), (b) for people who are overweight (BMI 25-30) and are also at risk of cardiovascular disease or diabetes, (c) and for people who are overweight and suffer from arthrosis or sleep apnea. GLI takes a combined approach with the aim of teaching people how to have a healthy diet and how to increase physical activity levels. The entire treatment programme takes two years. As of January 1st, 2019, the combined lifestyle intervention will be covered and reimbursed by the basic healthcare package, as provided by the Dutch Health Insurance Act. An estimated 3.5 million Dutch people aged between 18-75 years of age (28 percent of the population) will qualify for this treatment. The Dutch Ministry of Health commissioned the Dutch National Institute of Public health and the Environment (RIVM) to estimate the associated cost for health insurance companies in the first five years following introduction of GLI.Total costs would increase from 5 million euro in 2019 to almost 15 million euro by 2023, assuming that each year, 1.03 percent of the target population will be referred for the treatment by their general practitioners. In the event that more people are referred (2.5 percent per year), associated costs would increase from 12 million euro in the first year to a maximum of 35 million by the fifth year. However, if dropout rates turn out to be higher than is currently expected, the costs would be lower, with a maximum of 24 million euro by the fifth year at the highest expected referral rate of 2.5 percent annually.These estimated costs have been based on a Budget Impact Analysis (BIA). For this analysis, researchers first estimated the number of Dutch people who are likely to fall under the GLI terms of reimbursement. Then, a stepped approach was taken to estimate how many people would be referred by their general practitioner, how many people would then have an intake assessment, how many people would start treatment, and how many people would finish the entire treatment programme. These figures are based on three different Dutch studies regarding the effectiveness of GLI treatment

Physical and mental health outcomes of COVID-19 induced delay in oncological care: A systematic review

Background: During the COVID-19 pandemic cancer patients might have experienced delays in screening, diagnosis and/or treatment. A systematic review was conducted to give an overview of the effects of COVID-19 induced delays in oncological care on the physical and mental health outcomes of cancer patients. Methods: MEDLINE and EMBASE databases were searched for articles on the effects of COVID-19 induced delays on physical and mental health outcomes. Results: Out of 1333 papers, eighteen observational, and twelve modelling studies were included. In approximately half of the studies, tumor stage distribution differed during the pandemic compared to before the pandemic. Modelling studies predicted that the estimated increase in the number of deaths ranged from -0.04 to 30%, and the estimated reduction in survival ranged from 0.4 to 35%. Varying results on the impact on mental health, e.g. anxiety and depression, were seen. Conclusions: Due to large methodological discrepancies between the studies and the varying results, the effect of COVID-19 induced delays on the physical and mental health outcomes of cancer patients remains uncertain. While modelling studies estimated an increase in mortality, observational studies suggest that mortality might not increase to a large extent. More longitudinal observational data from the pandemic period is needed for more conclusive results