Mathematical Modeling and Pharmaceutical Pricing: Analyses Used to Inform In-Licensing and Developmental Go/No-Go Decisions

In the face of significant real healthcare cost inflation, pressured budgets, and ongoing launches of myriad technology of uncertain value, payers have formalized new valuation techniques that represent a barrier to entry for drugs. Cost-effectiveness analysis predominates among these methods, which involves differencing a new technological interventions marginal costs and benefits with a comparators, and comparing the resulting ratio to a payers willingness-to-pay threshold. In this paper we describe how firms are able to model the feasible range of future product prices when making in-licensing and developmental Go/No-Go decisions by considering payers use of the cost-effectiveness method. We illustrate this analytic method with a simple deterministic example and then incorporate stochastic assumptions using both analytic and simulation methods. Using this strategic approach, firms may reduce product development and in-licensing risk.The FDA in the United States or the EMEA in Europe. Coverage and reimbursement decision making for new technology entering European markets occurs at the country-level     

Perceptions of Risk,Stressors, and Locus of Control Influence Intentions to Practice Safety Behaviors in Agriculture

ABSTRACT

This article argues that a combination of factors including risk perceptions, locus of control, and chronic stress influences farmers' intentions to behave safely. To demonstrate how these intervening variables influence behavioral intentions, results of 16 empirical research projects are superimposed upon an extensive literature review. Analyses include data collected from 3165 respondents via survey questionnaires, couple and key informant interviews, quasi-experimental evaluation instruments, and focus group dialogue. Using Ajzen's framework, this multilayered research process yields a wealth of both qualitative and quantitative data to support the argument.

The results suggest that information alone will not affect behavior. Only when chronic stressors from occupational and structural processes are alleviated and coping mechanisms introduced, the political economy of farming improves, and farm populations perceive that they are in control of their work environment will meaningful reduction in agricultural injuries and agricultural-related disease be possible.     

医疗风险管理现状调查

目的通过了解苏州大学附属第二医院的医疗风险现状以及预防医疗风险采取的措施,完善医院医疗安全管理体系。方法分别对患者和医护人员进行实地问卷调查,运用各种软件进行定量的数据处理,运用社会学、经济学、政治学等多学科理论进行规范化定性、定量分析。结果医院在制度建设方面及员工培训教育方面较完善,同时员工职业压力也很大,在一定程度上增加了医疗风险的发生率。结论医院制度建设健全,培训制度较完备,但仍需加强管理及宣传工作,完善不足。     

居民对台风灾害影响的认知及应对能力分析

目的：为探讨灾民对灾害事件的风险认知及应对能力,以台风为背景分析居民对灾害风险的认知及影响特征。方法：采用整群抽样方法对浙江省某台风登陆及影响区域的434名居民进行问卷调查,问卷内容包括人口学特征、台风相关风险认知以及采取的应对能力,数据进行分析。结果：84.6%居民认为台风知识教育是重要的,电视广播和经验分享是其获得相关信息主要途径;台风登陆区居民对台风灾害的风险认知明显高于周边区居民,以生命、财产和生活品质危害影响为主要因素（P≤0.001）;在台风灾害的应对能力方面,登陆区居民认为邻里亲友互助更为重要,并对居住物的坚固和居住区域安全更为关心;相关性分析提示不同年龄、文化教育、经济收入及居住区域与台风认知担忧有相关显著（P〈0.05）。结论：明确居民对灾害的风险认知,可预测灾害可能出现社会心理、行为变化,有助于提高人们认识灾害风险和减灾措施,增强居民应急能力。     

Knowledge and Perceptions of Non-Nutritive Sweeteners Within the UK Adult Population

Non-nutritive sweeteners (NNS) are popular sugar substitutes that can help in weight and diabetes management, but concerns regarding their use have been raised by the public. This study aimed to investigate knowledge, benefits and safety perceptions of NNS in a sample of UK adults. The impact of knowledge dissemination on the change in perceptions was also examined. An online survey was distributed through social media platforms and UK Universities and was completed by 1589 participants aged 18 years and above. Results showed a high-risk perception of NNS and a lack of knowledge in regulations in nearly half the population sample. The artificial attributes of NNS further limited their acceptance. Risk perception has been significantly linked to a lower consumption of sweeteners (p < 0.001) and was affected by gender, occupation, education levels, age and body weight status. Information dissemination significantly reduced risk perception and increased awareness of the benefits of NNS. Results suggest that developing effective communication strategies to educate consumers, potentially through trusted health government agencies and professional bodies, can help them to make informed choices. Education of health professionals could also be valuable in reassuring the public of the benefits of NNS.     

Sticky Decisions: Peanut Butter in a Time of Salmonella

We present a consumer-focused perspective on creating communications regarding potentially contaminated foods. It is illustrated with decisions that might have faced US consumers during the 2009 recalls of peanut and pistachio products. The example shows how knowledge about test results and regulatory processes might be made more useful to consumers.     

Protocol for the Assessment of Patient Capacity to Make End-of-Life Treatment Decisions

Patients' right to decide what happens to their bodies, especially around the end of life, is enshrined in legislation across the world, but questions often arise about whether a patient is capable of meaningfully participating in such decisions. Because of uncertainties about capacity, care providers and administrative agencies often must decide whether to honor, or even to elicit, patients' wishes. General decision-making capacity has been well studied, but few clear protocols exist for ascertaining capacity at the end of life. Without clear guidelines about how to assess capacity, medical staff may ignore assessment and operate from invalid assumptions. In the interests of protecting patients' agency, we propose a straightforward protocol for assessing capacity to make decisions about end-of-life interventions.     

Community and Campus COVID-19 Risk Uncertainty Under University Reopening Scenarios: Model-Based Analysis

BackgroundSignificant uncertainty has existed about the safety of reopening college and university campuses before the COVID-19 pandemic is better controlled. Moreover, little is known about the effects that on-campus students may have on local higher-risk communities.ObjectiveWe aimed to estimate the range of potential community and campus COVID-19 exposures, infections, and mortality under various university reopening plans and uncertainties.MethodsWe developed campus-only, community-only, and campus × community epidemic differential equations and agent-based models, with inputs estimated via published and grey literature, expert opinion, and parameter search algorithms. Campus opening plans (spanning fully open, hybrid, and fully virtual approaches) were identified from websites and publications. Additional student and community exposures, infections, and mortality over 16-week semesters were estimated under each scenario, with 10% trimmed medians, standard deviations, and probability intervals computed to omit extreme outliers. Sensitivity analyses were conducted to inform potential effective interventions.ResultsPredicted 16-week campus and additional community exposures, infections, and mortality for the base case with no precautions (or negligible compliance) varied significantly from their medians (4- to 10-fold). Over 5% of on-campus students were infected after a mean of 76 (SD 17) days, with the greatest increase (first inflection point) occurring on average on day 84 (SD 10.2 days) of the semester and with total additional community exposures, infections, and mortality ranging from 1-187, 13-820, and 1-21 per 10,000 residents, respectively. Reopening precautions reduced infections by 24%-26% and mortality by 36%-50% in both populations. Beyond campus and community reproductive numbers, sensitivity analysis indicated no dominant factors that interventions could primarily target to reduce the magnitude and variability in outcomes, suggesting the importance of comprehensive public health measures and surveillance.ConclusionsCommunity and campus COVID-19 exposures, infections, and mortality resulting from reopening campuses are highly unpredictable regardless of precautions. Public health implications include the need for effective surveillance and flexible campus operations.     

Risk factors and epidemiology of breast cancer

Breast cancer is the most common form of cancer and the principal cause of death from cancer among women worldwide. Risk factors for breast cancer are manifold. Certain risk factors, such as age and family history are well established. Research in the past decade has further elucidated disease aetiology, in particular the role of hormones and the discovery of breast cancer susceptibility genes (e.g. BRCA1, BRCA2). In spite of the evidence concerning the risks of breast cancer, women often have a poor understanding of its causes and limited personal risk perception. The media are an important source of health information for many women, but the popular and general-interest media often misrepresent risk factors. Knowledge of breast cancer risk factors and perception of personal risk are significant behaviour motivators to prevent, detect and manage disease. This article will review the risk factors for breast cancer, and examine the research on women’s perception of risk and understanding of risk factors, and the reporting of breast cancer in the media.     

愤怒和恐惧情绪对青少年风险决策行为影响研究

目的探讨愤怒和恐惧两种不同情绪对青少年风险决策行为的影响。方法两组被试分别观看不同的影片以诱发愤怒和恐惧情绪,之后完成有关赌博任务的问卷。结果不同情绪对青少年风险决策行为具有显著的影响(F=4.668,P<0.05),并且青少年愤怒情绪状态下比在恐惧情绪状态下更倾向于冒险,而不同情绪状态下的男女青少年的风险决策行为没有显著差异。结论愤怒和恐惧两种不同情绪对青少年风险决策有不同的影响。     

Initial UK public reaction to avian influenza: Analysis of opinions posted on the BBC website

In February 2007, avian influenza arrived in the UK. Following evidence of illness at a turkey farm in Suffolk, around 160,000 birds were slaughtered and poultry movement controls were imposed. Given past food crises (e.g. BSE), it was clearly important to predict UK public response: for example, was mass panic imminent, or would the public respond calmly? Unfortunately, there is currently no theory that enables accurate prediction of public response to novel hazards or to novel manifestations of old hazards (Hawkes and Rowe in press Hawkes, G. and Rowe, G. in press. A structured review of qualitative research on the nature of perceived risk: Trends and omissions. Journal of risk research,  [Google Scholar]). Furthermore, the speed of the outbreak, and the lack of academic preparedness, undermined social scientists' ability to acquire significant timely data on public perceptions in order to aid theory development or inform policy making. Analysis of initial public opinion is, however, possible, thanks to the recording of responses to open questions about this incident posted on the British Broadcasting Corporation's (BBC) website. In this paper we: (a) justify the relevance and importance of this data, irrespective of deficiencies in its ‘representativeness’; (b) provide a content analysis of the more than 3,000 responses, and; (c) summarize initial opinion. Results suggest that ‘the public's’ initial response largely comprised discontent in how government was managing matters and concern about current farming practices. Indeed, for many, past food scares served as a reference point for understanding the present crisis, providing lessons on issues such as industry greed and governmental/scientific incompetence and misinformation. It is, however, important to recognize that there are data limitations, which need validation through more controlled research processes.     

Introducing incident reporting in primary care: a translation from safety science into medical practice

In this article, we examine how incident reporting procedures become part of the way primary health care professionals deal with safety problems. Between 2006 and 2010, we studied documents, observed incident reporting committee meetings and conducted formal and informal interviews in five Dutch primary health care centres and one general practitioner's out-of-hours service to describe the introduction of incident reporting procedures. In this article, we distinguish two approaches towards patient safety, the logic of risk management and the logic of medical practice. In the logic of risk management, safety is seen in terms of the prevention of recurrence of specific well-defined incidents. In the logic of medical practice, safety involves recognising uncertainties and strengthening implicit initiatives that underpin patient safety. Care providers alternated between the two logics and aligned them. Most reported incidents in primary care concern non-clinical incidents with no or limited impact on the patient. We observed that both physicians and medical assistants changed the significance of a particular incident by frequent reporting. By reporting apparently insignificant risks, those providing care were able to deal with these risks more explicitly and actively. The alignment of the two logics was different for clinical, more harmful incidents. Care providers rarely reported serious clinical incidents and we could find little evidence that they actively engaged with recommendations following the investigation of serious incidents. Both logics mutually shaped and informed each other. Incident reporting procedures made implicit initiatives explicit and the two logics ensure that safety involved multiple and different actions.     

Risk perception for diabetes in Appalachian women

The social and economic burden of diabetes is large and growing. Diabetes is a significant public health issue in the Appalachian region; women constitute approximately 50% of those diagnosed with diabetes. This cross-sectional study examined the relationship among sociodemographic, anthropometric, lifestyle, and psychosocial factors (cognitive and affective representations) and perceived risk of diabetes in non-diabetic, non-elderly (21–50 years) Appalachian women residing in West Virginia (N = 202). Participants were recruited through social media, flyers, and a newsletter from the West Virginia University Extension. The final survey was conducted from March 2015 to June 2015. Bivariate analyses were used to examine unadjusted relations among sociodemographic, anthropometric, lifestyle, and psychosocial factors and comparative perceived risk of diabetes. In a multivariable logistic regression model, we found that younger age, higher body mass index, non-White race, greater diabetes knowledge, personal control, and moderate amounts of physical activity were significantly, positively associated with higher diabetes risk perception (p < .05). Our results indicated that diabetes knowledge, personal control, and physical activity were related to diabetes risk perception among Appalachian women. Understanding perceived diabetes-related risk may aid in the development of effective intervention strategies to reduce the burden of diabetes among Appalachian and other populations. These cross-sectional findings need further evaluation in longitudinal studies.     

Risk perception of women during high risk pregnancy: A systematic review

Risk perception in women with high risk pregnancies can affect their attitude to medical care and therefore influence the wellbeing of mother and baby. This article reviews quantitative measures of risk perception in women with high risk pregnancies. A systematic search of eight electronic databases was conducted. Additional articles were obtained through searching references of identified articles. Seven studies were identified that reported quantitative measures of risk perception in relation to high risk pregnancy. The main findings were that women with high risk pregnancies perceive themselves and the pregnancies to be at risk. However, mean risk scores consistently fall below the midpoint on risk perception measures suggesting women do not perceive this risk as extreme. Women with high risk pregnancies consistently rated their risk as being greater than that of women with low risk pregnancies. Results were inconsistent for the association between women's risk perception and that of healthcare professionals. Women with higher socio-economic status were more likely to be concerned about risk, although lower socio-economic status is associated with increased risk in pregnancy. There was a consistent association between high risk pregnancy and higher levels of anxiety. This review indicates that women at high risk during pregnancy do not perceive this risk to be extreme and that there is poor agreement between women's and healthcare professionals’ perceptions of risk. This is likely to have implications for medical care and pregnancy outcomes.     

农村外出务工人员艾滋病知识、态度及高危行为分析

目的了解农村外出务工人员艾滋病防治知识、相关态度和高危行为状况,为开展艾滋病干预工作提供科学依据。方法采用多阶段抽样方法,在流出地选择返乡外出务工人员454人,利用自制问卷面对面调查。结果外出务工人员对艾滋病3大传播途径回答正确率为43．6％～68．6％,对一般日常生活接触是否传播MDS的知晓率偏低,如蚊虫叮咬不会传播的知晓率只有19．3％;93．1％的外出务工人员认为自己感染艾滋病的机会很小,仅有48．1％的人表示同情并愿意给予艾滋病患者帮助;21．6％的人有婚前性行为,71．0％的人与固定性伴发生性关系时从不使用安全套。结论外出务工人员艾滋病防治知识缺乏,普遍存在危险性行为。     

广州市少教所学员性病艾滋病高危因素调查分析

目的调查羁押场所青少年学员中性行为状况及感染性病艾滋病的高危因素,为性病综合干预提供指导。方法采用调查问卷方式对学员进行性行为调查;同时对学员进行皮肤性病调查;并根据他们当中性病的感染情况,分析有关高危因素。结果青少年学员中总体首次性生活年龄提前,13岁以下者占5.1%,16岁以前84.6%的人都有性生活史;58.3%的学员有超过2个性伴,17.9%的人有超过5个性伴;性病防护意识薄弱,安全套使用意识差,只有17.3%的人在性生活中每次都使用安全套,而48.1%的人从不使用安全套。结论进一步加强对青少年性病艾滋病知识教育、在这一人群中进行安全套推广十分必要。     

Health risk perception and shale development in the UK and US

In this paper, we examine discourse in public deliberations in pre-development locales in the UK and US about advantages and disadvantages of future shale development (‘fracking’). We aimed to understand how people anticipate potential health effects, broadly construed, of environmental toxicity and disturbance in the context of planned, but not yet implemented, energy development. In day-long deliberations with small, diverse groups in two cities in each country (London, Cardiff in the UK; Los Angeles, Santa Barbara in the US), participants discussed impacts on health and well-being using three main rubrics: ‘It’s money or health’, ‘Why take chances?’ and ‘Beyond the tipping point’. Throughout, participants framed health as an intrinsically moral issue, with collective responsibility as a dominant normative frame. We identify the concept of compound risk to underscore effects of multiple risks and hazards on people’s sensibilities about anticipated future health and environmental harm. The findings demonstrate how and why diverse publics in pre-impact sites in both countries saw shale extraction as high stakes development that poses significant, often unacceptable, risks to human and environmental health and well-being. Risks extended beyond toxicity to broad threats to health, including, for some, the end of life as we know it on the planet. Overall, participants’ discussions of health were more connected to social categories and their underlying moral principles than to technological details. This work contributes evidence of blurred boundaries between environment and health as well as the importance people place on social risks in the context of proposed energy system change.     

Risk perception,somatization, and self report of complaints related to electromagnetic fields--a randomized survey study

Exposure to electromagnetic fields (EMF) as well as EMF-related complaints has increased over the past decades. However, it is unclear whether these complaints are related to the electromagnetic or other physical properties of these fields per se, to salience of EMF in media, or to both. What is the prevalence of EMF-related complaints in the general population? What are the influencing factors on this prevalence? Does reporting of EMF-related symptoms depend on cognitive factors? To answer these questions, a survey with random variation of three cognitive factors was performed. As expected, EMF-related complaints were reported more by females and people with higher somatization tendency. Age had no significant linear effect on EMF-related complaints. The cognitive condition of threat produced a significant contrast effect among people with high somatization tendency on EMF-related complaints. Cognition can influence reporting of EMF-related effects. Thus, in future research of such effects, psychologically influencing factors should be included. Also risk communication should incorporate knowledge about social cognition.     

Public perception of population health risks in Canada: Risk perception beliefs

A national survey of health risk perception among 1,503 adult Canadians was conducted in 2004 as a follow-up to a previous survey in 1992. Respondents were asked to indicate their personal opinion regarding a range of risk perception belief statements reflecting environmental concern, social concern, genetic concern, dependence on regulators, locus of health risk control (internal, powerful others, chance), risk acceptability and technological enthusiasm. The results indicated considerable concern over the state of the environment in general, however, less concern existed for the environment nearest to the individual. A high degree of concern was expressed over stress in the workplace, and poverty was perceived to represent an important health risk for Canadians. A strong sense of the importance of personal lifestyle factors and personal control over one's health was also observed as were notable increases in trust and dependence on the ability of government and experts to make decisions and regulate health risks in Canada as compared to the previous survey. Belief statements reflecting environmental and social concern correlated with the level of risk perceived for a variety of health hazards and outcomes.