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In Spring 2015, Texas experienced record-breaking floods, causing deaths, injuries, and widespread property and infrastructure damage. However, little is known about those who encountered access barriers to disaster support in Texas. The purpose of this paper is to examine the unmet disaster-related needs from 2-1-1 calls during evacuation, flooding, and early recovery phases.

The 2-1-1 Texas Information and Referral Network’s caller database was used to identify real time, non-emergency, unmet disaster-related caller needs longitudinally. The two-month study period included a baseline week before flashflood (05/01/2015) into early recovery (06/30/2015). Caller unmet needs were categorized and graphed by type daily throughout the study period.

Of the 4,880 disaster-related 2-1-1 calls from Texas’ 254 counties, 1,183 callers needed housing help, compared to 442 utilities, 409 food and 109 medically related assistance. Total calls quickly peaked at 405 calls/day during Memorial Day weekend when Greater Houston flooded. Despite total calls decreasing gradually during recovery, they remained four times higher than baseline. Unmet needs varied by type, especially during early recovery. Housing, food, and medical unmet needs surged when Houston flooded. Although medical calls were lowest volume than other basic needs, demand for medical assistance had a higher threshold throughout early recovery.

Examination of unmet needs over disaster phases identified longitudinal patterns of demand and effectiveness of disaster management efforts.

Using real-time 2-1-1 data to monitor types of unmet demand is valuable to tailor timely and effective disaster support, reduce access barriers, and allocate disaster support services and supplies to the vulnerable communities.

This chapter examines social variations in parent dissatisfaction with children’s medical care and tests whether greater dissatisfaction is associated with less preventive care and unmet medical need.

The 2007 National Survey of Children’s Health (NSCH) is a nationally representative cross-sectional sample of parents of U.S. children age 0–17 years (N=78,523). We use a combination of ordinary least squares (OLS) and binary logistic regression to analyze parent dissatisfaction, preventive care, and unmet medical need.

Our results indicate that parents’ dissatisfaction scores are significantly higher for racial/ethnic minorities, non-English speakers, lower socioeconomic status (SES) respondents, and the uninsured. Furthermore, parent dissatisfaction has a significant and robust association with lack of preventive care and reports of unmet medical need.

Due to the cross-sectional research design, we were unable to determine whether dissatisfaction caused parents to delay children’s medical care, thus resulting in a lack of annual preventive care and greater unmet needs.

Although there is extensive research on adult perceptions of their own medical care, few sociological studies have examined parents’ perceptions about their children’s care. Yet, there is substantial evidence that parents transmit health-related attitudes, beliefs, and behaviors to their children. As with adult patients, parent satisfaction with their child’s medical care is stratified by social characteristics; however, we also find a strong association between dissatisfaction and use of other important health services. It may be the case that when parents feel that they did not receive satisfactory care, they are more likely to delay, or to forgo, preventive and other health services.

The purpose of this paper is to address three topical themes: user involvement in health services research; determining the value of new medical technologies in patient care pathways, furthering knowledge related to quality in health and social care; and knowledge exchange between manufacturers, health service supply chain networks and device users. The model is being validated in a case study in progress. The latter is a “proving ground” study for a translational research company. Medical devices play a pivotal role in the management of chronic diseases, across all care settings. Failure to engage users in device development inevitably affects the quality of clinical outcomes. A model of user engagement is presented, turning unmet needs for medical devices into viable commercial propositions.

A case study investigating the perceptions of individuals with Epidermolysis Bullosa (EB), their lay and professional carers into unmet needs. EB is an inherited condition affecting the skin and mucosal linings that leads to blistering and wounds.

Qualitative data are being collected to generate understanding of unmet needs and wound care products. These needs are being translated into new design concepts and prototypes. Prototypes will be evaluated in an n=1 experimental design, generating quantitative outcomes data.

There are generalisations from the case study, and the model outlined. New products for managing EB wounds can logically benefit other groups. The model is transferable to other clinical problems, which can benefit from research and technological advances that are integral to clinical needs and care.

We find the presence of a sibling with disability in a household is associated with greater risk of lower health status, unmet needs for routine medical care, and number of bed days due to sickness or injury. This is true both for children with or without disability. These relationships persist with controls for other aspects of the family environment that are associated with disability (socioeconomic status, family structure, and labor force participation). Having a co-resident sibling with disability rivals poverty, minority race or ethnic status, and one-parent households as a major risk factor for these negative child health outcomes.

This chapter focuses on the regulatory scheme used by the United States Food and Drug Administration (FDA) to approve medical products for commercial use in this country. After providing a brief introduction of the role of the FDA and the scope of the products regulated by the agency, the chapter outlines the common characteristics of premarket controls for drugs, medical devices, and biological products, including how clinical trials of these medical products are conducted with humans as part of the premarket approval process. The chapter then provides a detailed examination of the particular regulatory scheme for each product category. The chapter concludes with an analysis of how FDA regulates emerging medical technologies, such as cellular and tissue-engineered products. FDA regulates a variety of products intended to diagnose, cure, mitigate, treat, or prevent diseases or conditions under a legal scheme established in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act and regulations promulgated by FDA. How a product is classified (drug, device, or biologic) forecasts the regulatory approval pathway that must be followed to bring the product to market. This chapter provides education and direction regarding regulatory requirements that must be met to market medical products in the United States.

Evidence from a variety of sources suggests that there has been an increase of around 1% per annum in the prevalence of learning disability (LD) in adults over the last 35 years, due mainly to increases in survival. This trend is likely to continue for at least another ten years. Ninety‐six percent of adults notified to the Leicestershire LD register have an estimated IQ below 50 or need supervision every day to remain safe. Three‐quarters have additional significant disabilities including behaviour problems, psychological symptoms, physical dependencies or epilepsy. In one quarter the behaviour problem poses a major challenge to the achievement of an ordinary life. Two‐thirds indicate a need for help from one or other specialist. Informal carers are actively providing care for nearly half the adults, but a quarter are not content with care‐giving. Carers Report 40% more limiting health problems than their counterparts in the general population, in particular depression in women and cardiovascular problems in men. The specific areas of unmet need among carers Reporting depression are for financial help, long‐term social support and medical advice. Resource allocation for this client group needs to be reviewed in the light of substantial and unrecognised increases in prevalence which are continuing to occur, and the need for long‐term support.

This article aims to provide a description of principal aspects of policy and practice associated with orphan drugs and treatments of rare diseases, and give perspectives for 2011 on new and emerging approaches for addressing patient access.

Information has been synthesized from a wide variety of sources including the authors' experience and familiarity with this topic, having over the past ten years developed market access strategies for many orphan drugs. This is supplemented by pertinent information from conferences, meetings and articles published over the last 20 years and from policy documents released by relevant regulatory bodies.

While a small number of people suffer from any one rare disease, approximately 30 million in the EU and 25 million in the USA are affected by such diseases. Annual orphan drug treatment costs may approach $500,000. High costs coupled with relatively sparse supportive clinical data and difficulty in meeting standard cost‐effectiveness benchmarks raise significant issues for payers in allocating finite budgetary resources. Since the US (1983) and European (European Parliament, 2000) orphan drug regulations were approved, hundreds of agents have been granted orphan status although many fewer have achieved marketing authorization. Agencies have introduced a slew of incentives to help sponsors develop and market orphan medicinal products. The nature and focus of the programs are undergoing a metamorphosis as access to funding is becoming as important as supporting development.

The article represents a contemporary examination of orphan drug policy and practice, bringing together historic elements which influenced practice up to 2010 and the latest, emerging trends and approaches which stakeholders are now embracing and which will shape procedures from 2011.

The purpose of this study is to shed light on the importance of innovation and patient centricity to improve the existing pharmaceutical products. In the pharmaceutical industry, defining the “value” or “added value” of medicines is a very complex issue that requires objective information about how they can make people healthier and what “value” means to patients. In light of “value creation” strategy for the existing medicines, many original and generic pharmaceutical companies hope to create new portfolios to enter into new markets, to capture more market share or to strengthen their market position in the existing markets. The fact that “value” and “added value” are not static and change rather rapidly over the time, cannot always facilitate market access for the so-called improved or repurposed/repositioned versions now claiming “added-value” status. The only way “added value” category can promote smarter drug pricing scenarios and access to markets, is focusing on “patient Centricity” while innovating for satisfying their unmet medical needs.

This article is designed and structured by two methodologies: the first one is based on face to face interviews and the second one is focused on literature review regarding the value added pharmaceuticals.

There is an increasing confusion regarding “value-added” pharmaceuticals. This term is mainly used to define improved generic versions. This article discusses the “added-value” of this improvement for patients and manufacturers. By launching such products, these companies attempt to become more “innovative and patient-centric”. Furthermore, adopting a patient-centric strategy as a framework for optimizing the modified pharmaceuticals can create value, new pricing models may emerge through this strategy and can promote the “value” of these products by facilitating their access to higher margins.

Limited to an European discussion around the value-added pharmaceuticals.

The facts about value added medicines. The real classifications of these products.

For patients and health care systems, it is important to trust to real value in pharmaceutical treatments. If their “added value” is not justified by scientific proofs, if it is not patient centric, then they can occupy the status of the next generation of generic medicines a category between innovative and pure generics.

This is an original topic which was never discussed before.

In this study, the authors aimed to explore consumer perspectives on accelerated access to medicines. The authors were particularly interested in how they balance competing considerations of safety, efficacy, equity and access; whether and how their views change when there are different levels of uncertainty surrounding the safety and efficacy of new medicines; and the procedures that they think should be used to make decisions about accelerated access to new medicines.

This was an exploratory qualitative study. Thirteen semi-structured interviews with patient advocates and two focus groups with patients were conducted and analysed thematically. Interviews and focus groups were audio recorded and transcribed verbatim. Data were analysed through inductive thematic analysis.

Participants outlined a range of justifications for accelerated access, including addressing unmet medical needs and encouraging further research and development. However, they were also cognisant of the potential risks and viewed ongoing data collection, disinvestment and market withdrawal as ways to address these. They also emphasised the importance of transparent decisions being made by people with relevant expertise, based on a thorough consideration of scientific evidence and stakeholder perspectives.

This is the first study to comprehensively explore Australian consumers' views of accelerated access to medicines. The results suggest that consumers want timely access to new medicines, but not at the expense of safety, efficacy, equity and sustainability. While accelerated access programs are likely to be welcomed by consumers, they must be fully informed of their conditions and limitations, and robust post-market data surveillance must be implemented and enforced to protect the interests of both individual patients and the broader community.

This study examines the determinants of medical crowdfunding performance. Drawing on signaling theory, the authors investigate how funding-related signals (funding goal and duration), story-related signals (text length, text sentiment, and use of first-person pronouns), and donor-related signals (donor identity disclosure) affect medical crowdfunding performance.

This study analyzed the data of 754 medical crowdfunding projects collected from the Qingsongchou platform in China to test the proposed model.

The empirical findings reveal that both funding goal and funding duration exhibit a U-shaped relationship with crowdfunding performance. Additionally, the authors find evidence that story text length and donor identity disclosure are positively related to crowdfunding performance, whereas the use of first-person pronouns is negatively related to crowdfunding performance.

This study extends the understanding of the determinants of medical crowdfunding performance through the signaling theory. Specifically, this study provides new insights into the roles of funding goal and funding duration in predicting medical crowdfunding performance and identifies several new predictors of crowdfunding performance, including the use of first-person pronouns in project story text and donor identity disclosure.