Current Practices and Challenges When Submitting Patient Experience Data for Regulatory Decisions by the US Food and Drug Administration: An Industry Survey
ConclusionsFDA has policy targets expanding PED use, but challenges remain regarding pathways for PED submission and transparency in regulatory decision-making. Alignment on the use of existing meeting opportunities to discuss PED, co-development of the PED table, and expanded guidance are encouraged. (Source: The Patient - Patient-Centered Outcomes Research)
Source: The Patient - Patient-Centered Outcomes Research - December 12, 2023 Category: International Medicine & Public Health Source Type: research

A Review of the Use of EQ-5D for Clinical Outcome Assessment in Health Technology Assessment, Regulatory Claims, and Published Literature
AbstractThe aim is to identify the extent to which EQ-5D is used as a clinical outcome assessment (COA) endpoint in a non-economic context in health technology assessment (HTA) decisions, regulatory labelling claims and published literature. Drug technology appraisals (TAs) published by HTA agencies in England, France, Germany and the USA between 2019 and 2021 were identified. Product labelling for drugs approved by the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) between 2016 and 2021 were also identified. A systematic literature review (SLR) was also performed. Documents reporting EQ-5D in th...
Source: The Patient - Patient-Centered Outcomes Research - December 12, 2023 Category: International Medicine & Public Health Source Type: research

Current Practices and Challenges When Submitting Patient Experience Data for Regulatory Decisions by the US Food and Drug Administration: An Industry Survey
ConclusionsFDA has policy targets expanding PED use, but challenges remain regarding pathways for PED submission and transparency in regulatory decision-making. Alignment on the use of existing meeting opportunities to discuss PED, co-development of the PED table, and expanded guidance are encouraged. (Source: The Patient - Patient-Centered Outcomes Research)
Source: The Patient - Patient-Centered Outcomes Research - December 12, 2023 Category: International Medicine & Public Health Source Type: research

A Review of the Use of EQ-5D for Clinical Outcome Assessment in Health Technology Assessment, Regulatory Claims, and Published Literature
AbstractThe aim is to identify the extent to which EQ-5D is used as a clinical outcome assessment (COA) endpoint in a non-economic context in health technology assessment (HTA) decisions, regulatory labelling claims and published literature. Drug technology appraisals (TAs) published by HTA agencies in England, France, Germany and the USA between 2019 and 2021 were identified. Product labelling for drugs approved by the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) between 2016 and 2021 were also identified. A systematic literature review (SLR) was also performed. Documents reporting EQ-5D in th...
Source: The Patient - Patient-Centered Outcomes Research - December 12, 2023 Category: International Medicine & Public Health Source Type: research

Exploring the Preferences of Parents of Children with Myopia in Rural China for Eye Care Services Under Privatization Policy: Evidence from a Discrete Choice Experiment
ConclusionsThe privatization policy on children ’s eye care services would not cater to the preferences of rural consumers, inevitably leading to welfare losses. However, reduced consumer welfare could be compensated by improving the quality of products and service delivery from private providers. These results could help inform strategies to improve and reduce inequities in access to high-quality eye care services in rural China. (Source: The Patient - Patient-Centered Outcomes Research)
Source: The Patient - Patient-Centered Outcomes Research - December 10, 2023 Category: International Medicine & Public Health Source Type: research

A Best –Worst Scaling Study of the General Population's Preferences for Activities in Living Arrangements for Persons With Dementia
In this study, a best –worst scaling (BWS) was conducted to gather insights on preferred activities in small-scale living arrangements for dementia in the general population aged 50–65 years from rural and urban regions.MethodsBWS tasks were developed based on literature searches and focus groups. The final BWS contains ten activities, namely ‘interaction with animals’, ‘gardening’, ‘painting, handicrafts, manual activities’, ‘household activities (e.g., folding laundry, cooking)’, ‘watching television’, ‘practicing religion’, ‘listening to music and singing familiar songs’, ‘conversations...
Source: The Patient - Patient-Centered Outcomes Research - December 8, 2023 Category: International Medicine & Public Health Source Type: research

Quality of Life in Adults with Chronic Cough: A Mixed Methods Study Informing the Development of a Quantitative Patient Preference Study
ConclusionsThis study emphasizes the importance of coughing episodes for adults with CC and provides initial evidence that taste alterations are an important component of patient treatment decisions for CC. (Source: The Patient - Patient-Centered Outcomes Research)
Source: The Patient - Patient-Centered Outcomes Research - December 7, 2023 Category: International Medicine & Public Health Source Type: research

Preferences and Willingness to Pay for Medication in Patients with Renal Cell Carcinoma in China: A Discrete-Choice Experiment
ConclusionsIn China, patients with renal cell carcinoma preferred medications with better efficacy (objective response rate and progression-free survival) and lower out-of-pocket costs. Heterogeneity can be found in preferences and willingness to pay based on patients ’ gender, income, and education levels. (Source: The Patient - Patient-Centered Outcomes Research)
Source: The Patient - Patient-Centered Outcomes Research - November 29, 2023 Category: International Medicine & Public Health Source Type: research

Preferences for Monitoring Comprehensive Heart Failure Care: A Latent Class Analysis
ConclusionUsing LCA, variations in preferences among different groups of patients with chronic heart failure were examined. This allows treatment alternatives to be adapted to individual needs of patients and patient groups. The findings of the study enhance clinical and allocative decision-making while elevating the quality of clinical data interpretation. (Source: The Patient - Patient-Centered Outcomes Research)
Source: The Patient - Patient-Centered Outcomes Research - November 29, 2023 Category: International Medicine & Public Health Source Type: research

Preferences and Willingness to Pay for Medication in Patients with Renal Cell Carcinoma in China: A Discrete-Choice Experiment
ConclusionsIn China, patients with renal cell carcinoma preferred medications with better efficacy (objective response rate and progression-free survival) and lower out-of-pocket costs. Heterogeneity can be found in preferences and willingness to pay based on patients ’ gender, income, and education levels. (Source: The Patient - Patient-Centered Outcomes Research)
Source: The Patient - Patient-Centered Outcomes Research - November 29, 2023 Category: International Medicine & Public Health Source Type: research

Preferences for Monitoring Comprehensive Heart Failure Care: A Latent Class Analysis
ConclusionUsing LCA, variations in preferences among different groups of patients with chronic heart failure were examined. This allows treatment alternatives to be adapted to individual needs of patients and patient groups. The findings of the study enhance clinical and allocative decision-making while elevating the quality of clinical data interpretation. (Source: The Patient - Patient-Centered Outcomes Research)
Source: The Patient - Patient-Centered Outcomes Research - November 29, 2023 Category: International Medicine & Public Health Source Type: research