Notes

Scientific along with epidemiological qualities regarding child COVID-19 patients in a community-based examine
A recent debate in health economics and outcomes research community identified option value as one of the elements warranting consideration in the assessment of medical technologies. To conduct a scoping review of contributions on option value in the healthcare sector and identify relevant conceptual aspects and methods used to incorporate it in standard economic evaluations.

A systematic search was conducted up to July 2020 to identify contributions from electronic bibliographic database and gray literature. Data on the proposed definitions of option value, theoretical implications of its use in economic evaluations, and methods used to estimate it were extracted and analyzed.

We found 57 eligible studies. Three different definitions emerged insurance value, real option value, and option value of survival. Focusing on the latter (24 studies), we analyzed in depth 8 empirical applications across 7 therapeutic areas. The most relevant methodological challenges were on the perspective used in economic evae estimation.
This article aims to explore overlaps and differences between the emerging concept of value-based healthcare (VBHC) and the established field of cost-effectiveness analysis (CEA), as well as the feasibility of integrating them together. Interest in VBHC has grown significantly in developed countries that seek to preserve the sustainability of their healthcare systems. Consequently, it is likely that VBHC will soon play a meaningful role in health economic policy and decision making. Because VBHC and CEA share many similarities, academics have pointed out that integration could lead to opportunities for improvements in both fields.

An exploration of overlapping topics in VBHC and CEA literature was performed to establish initial links between them. A new methodologic approach is described to consolidate key value frameworks from the respective fields.

Several key themes emerged in which these 2 concepts can reinforce each other interpretation of value, sensitivity to outcome changes, scientific credibili implementation, while the latter can complement the former with a new viewpoint and conceptual toolbox for patient centricity and the definition of value.
Assessing public attitudes about genomic medicine is critical for anticipating patient receptivity to clinical applications of genomics. NAMPT inhibitor Although scholars have highlighted the importance of assessing stakeholder opinions and views regarding advances in clinical genomics, to date there has not been a robust tool for measuring these attitudes. We designed a study to evaluate the validity of an instrument we developed for measuring attitudes about genomic medicine.

We used psychometric methods to validate the Genomic Orientation Scale (GO Scale). Our goal was to create an easy-to-use tool for evaluating positive and negative attitudes about genomic medicine.

We describe the validation testing of the GO Scale in a nationally representative sample of 1536 individuals residing in the United States. We report results from convergent and divergent validity testing and Rasch modeling analysis. The study produced a 26-item scale with 2 dimensions-optimism and pessimism.

The GO Scale may be used to characterize attitudinal perspectives among patients, clinicians, and the public. The GO Scale may also be useful in evaluating shifts in attitude over time, for example, following educational interventions, which has not been feasible to date.
The GO Scale may be used to characterize attitudinal perspectives among patients, clinicians, and the public. The GO Scale may also be useful in evaluating shifts in attitude over time, for example, following educational interventions, which has not been feasible to date.
Patient preference information (PPI) is a way to incorporate the patient voice in the evaluation of medical devices. The US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has been working to encourage the voluntary inclusion of PPI throughout the medical device lifecycle for nearly a decade. This article reflects CDRH's efforts to encourage collection of PPI and offers perspectives on the future of PPI in the evaluation of medical devices.

CDRH regulatory guidance, public meetings, and collaborations relating to PPI were explored.

Since 2012 when CDRH issued guidance on how PPI can be used as scientific evidence in the benefit-risk regulatory submission, CDRH has issued 5 subsequent guidance documents expanding on the use of PPI in medical device evaluations. CDRH remains committed to advancing the science and application of PPI in the medical device ecosystem through many collaborations with professional organizations, patient advocacy groups, and academic institutions. By hosting and actively participating in multiple scientific and regulatory public meetings and conferences, CDRH fosters a continuous learning environment where the experience of using PPI in regulatory submissions can be shared. A September 2020 meeting cosponsored by FDA and International Society for Pharmacoeconomics and Outcomes Research (ISPOR) discussed the state of PPI in regulatory applications and beyond.

This article describes these pivotal events that have helped to increase the use of PPI in medical device evaluation as well as discusses future applications of PPI.
This article describes these pivotal events that have helped to increase the use of PPI in medical device evaluation as well as discusses future applications of PPI.
Identify disease categories in which single-item global impression (GI) scales were included in product labeling of new drugs approved by the US Food and Drug Administration (FDA) in January 2009-December 2019 and review the characteristics of GIs included in product labeling of new FDA-approved drugs (January 2017-December 2019).

FDA Clinical Outcome Assessment (COA) Compendium was reviewed for drug labels that included GIs for drugs approved in 2009-2016. The indication, year of approval, ICD-10 code, and GI respondent were noted. A manual review of labels of FDA-approved drugs (2017-2019) was undertaken to identify GIs included in the labels. Corresponding drug approval packages were reviewed to identify details of any regulatory reviewer comments related to GIs. GI characteristics were noted from the drug label or the review documents, including the respondent, type of measure (static or dynamic), item wording, concept assessed, and response options.

Product labeling containing GIs was most common in diseases related to the skin, nervous system, behavioral disorders, and the musculoskeletal system.
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