Impact of overweight and obesity on hospitalization: race and gender differences

To examine associations between weight status and number of all-cause and cause-specific hospitalizations overall, and by race and gender

Factors and situations influencing the value of patient preference studies along the medical product lifecycle: a literature review

Industry, regulators, health technology assessment (HTA) bodies, and payers are exploring the use of patient preferences in their decision-making processes. In general, experience in conducting and assessing patient preference studies is limited. Here, we performed a systematic literature search and review to identify factors and situations influencing the value of patient preference studies, as well as applications throughout the medical product lifecyle. Factors and situations identified in 113 publications related to the organization, design, and conduct of studies, and to communication and use of results. Although current use of patient preferences is limited, we identified possible applications in discovery, clinical development, marketing authorization, HTA, and postmarketing phases. This study can inform different stakeholders on how to conduct, assess, and use patient preference studies and on when to include patient preference studies in development plans

HbA 1C variability and hypoglycemia hospitalization in adults with type 1 and type 2 diabetes: A nested case-control study

Aims To determine association between HbA1C variability and hypoglycemia requiring hospitalization (HH) in adults with type 1 diabetes (T1D) and type 2 diabetes (T2D). Methods Using nested case-control design in electronic health record data in England, one case with first or recurrent HH was matched to one control who had not experienced HH in incident T1D and T2D adults. HbA1C variability was determined by standard deviation of ≥ 3 HbA1C results. Conditional logistic models were applied to determine association of HbA1C variability with first and recurrent HH. Results In T1D, every 1.0% increase in HbA1C variability was associated with 90% higher first HH risk (95% CI, 1.25–2.89) and 392% higher recurrent HH risk (95% CI, 1.17–20.61). In T2D, a 1.0% increase in HbA1C variability was associated with 556% higher first HH risk (95% CI, 3.88–11.08) and 573% higher recurrent HH risk (95% CI,1.59–28.51). In T2D for first HH, the association was the strongest in non-insulin non-sulfonylurea users (P < 0.0001); for recurrent HH, the association was stronger in insulin users than sulfonylurea users (P = 0.07). The HbA1C variability-HH association was stronger in more recent years in T2D (P ≤ 0.004). Conclusions HbA1C variability is a strong predictor for HH in T1D and T2D

Opportunities and challenges for the inclusion of patient preferences in the medical product life cycle: a systematic review

BACKGROUND: The inclusion of patient preferences (PP) in the medical product life cycle is a topic of growing interest to stakeholders such as academics, Health Technology Assessment (HTA) bodies, reimbursement agencies, industry, patients, physicians and regulators. This review aimed to understand the potential roles, reasons for using PP and the expectations, concerns and requirements associated with PP in industry processes, regulatory benefit-risk assessment (BRA) and marketing authorization (MA), and HTA and reimbursement decision-making. METHODS: A systematic review of peer-reviewed and grey literature published between January 2011 and March 2018 was performed. Consulted databases were EconLit, Embase, Guidelines International Network, PsycINFO and PubMed. A two-step strategy was used to select literature. Literature was analyzed using NVivo (QSR international). RESULTS: From 1015 initially identified documents, 72 were included. Most were written from an academic perspective (61%) and focused on PP in BRA/MA and/or HTA/reimbursement (73%). Using PP to improve understanding of patients' valuations of treatment outcomes, patients' benefit-risk trade-offs and preference heterogeneity were roles identified in all three decision-making contexts. Reasons for using PP relate to the unique insights and position of patients and the positive effect of including PP on the quality of the decision-making process. Concerns shared across decision-making contexts included methodological questions concerning the validity, reliability and cognitive burden of preference methods. In order to use PP, general, operational and quality requirements were identified, including recognition of the importance of PP and ensuring patient understanding in PP studies. CONCLUSIONS: Despite the array of opportunities and added value of using PP throughout the different steps of the MPLC identified in this review, their inclusion in decision-making is hampered by methodological challenges and lack of specific guidance on how to tackle these challenges when undertaking PP studies. To support the development of such guidance, more best practice PP studies and PP studies investigating the methodological issues identified in this review are critically needed

Factors and Situations Affecting the Value of Patient Preference Studies: Semi-Structured Interviews in Europe and the US

Objectives: Patient preference information (PPI) is gaining recognition among the pharmaceutical industry, regulatory authorities, and health technology assessment (HTA) bodies/payers for use in assessments and decision-making along the medical product lifecycle (MPLC). This study aimed to identify factors and situations that influence the value of patient preference studies (PPS) in decision-making along the MPLC according to different stakeholders. Methods: Semi-structured interviews (n = 143) were conducted with six different stakeholder groups (physicians, academics, industry representa

Methods for exploring and eliciting patient preferences in the medical product lifecycle: a literature review.

Objectives: Patient preference information (PPI) is gaining recognition among the pharmaceutical industry, regulatory authorities, and health technology assessment (HTA) bodies/payers for use in assessments and decision-making along the medical product lifecycle (MPLC). This study

Factors and situations influencing the value of patient preference studies along the medical product lifecycle: a literature review

Industry, regulators, health technology assessment (HTA) bodies, and payers are exploring the use of patient preferences in their decision-making processes. In general, experience in conducting and assessing patient preference studies is limited. Here, we performed a systematic literature search and review to identify factors and situations influencing the value of patient preference studies, as well as applications throughout the medical product lifecyle. Factors and situations identified in 113 publications related to the organization, design, and conduct of studies, and to communication and use of results. Although current use of patient preferences is limited, we identified possible applications in discovery, clinical development, marketing authorization, HTA, and postmarketing phases