Statistical methods for handling missing data to align with treatment policy strategy

The International Council for Harmonization (ICH) E9(R1) addendum recommends choosing an appropriate estimand based on the study objectives in advance of trial design. One defining attribute of an estimand is the intercurrent event, specifically what is considered an intercurrent event and how it should be handled. The primary objective of a clinical study is usually to assess a product's effectiveness and safety based on the planned treatment regimen instead of the actual treatment received. The estimand using the treatment policy strategy, which collects and analyzes data regardless of the occurrence of intercurrent events, is usually utilized. In this article, we explain how missing data can be handled using the treatment policy strategy from the authors' viewpoint in connection with antihyperglycemic product development programs. The article discusses five statistical methods to impute missing data occurring after intercurrent events. All five methods are applied within the framework of the treatment policy strategy. The article compares the five methods via Markov Chain Monte Carlo simulations and showcases how three of these five methods have been applied to estimate the treatment effects published in the labels for three antihyperglycemic agents currently on the market.     

Concepts travelling across disciplinary fields: the case of the business model

Journal of Management and Governance - Since the beginning of the 2000s, the concept of Business Model has been explored by scholars from a broad range of business studies and particularly those in...     

Economic Disparities and Life Satisfaction in European Regions

This paper investigates the role of economic variables in predicting regional disparities in reported life satisfaction of European Union (EU) citizens. European subnational units (regions) are defined according to the first-level EU nomenclature of territorial units. We use multilevel modeling to explicitly account for the hierarchical nature of our data, respondents within regions and countries, and for understanding patterns of variation within and between regions. Main findings are that personal income matters more in poor regions than in rich regions, a pattern that still holds for regions within the same country. Being unemployed is negatively associated with life satisfaction even after controlled for income variation. Living in high unemployment regions does not alleviate the unhappiness of being out of work. After controlling for individual characteristics and modeling interactions, regional differences in life satisfaction still remain, confirming that regional dimension is relevant for life satisfaction.     

Attachment Representations and Time Perspective in Adolescence

This study examines the relationship between attachment to parents and peers, time perspective and psychological adjustment in adolescence. 2,665 adolescents (M age = 17.03 years, SD = 1.48) completed self-report measures about parent and peer attachment, time perspective, sympathy and self-determination. Subjects were divided into four groups based on their parent and peer attachment scores: high parent and high peer attachment, low peer and low parent, high parent and low peer, low parent and high peer. Higher levels of negative past of the Zimbardo Time Perspective Inventory were revealed, by post hoc analyses, in the group with low attachment to parent and peer. Unlike adolescents with low attachment to parents, adolescents who reported a secure attachment to parents had higher scores on positive past, hedonistic present, and future. Adolescents with high attachment to parent and peer and adolescents with high parent but low peer attachment had the highest scores on competence and authonomy.     

Identification of the mental workload of public employees in the administrative sector at a public university

In the workplace there are risk factors that can overwhelm the health of the worker causing physical and psychological disorders. Among these disorders, is occupational stress. Thus, this research proposes to measure the mental workload of job stress from the identification of demand, control and social support. It is an observational cross-sectional epidemiological character, performed with the Rectory office workers at the State University of West Paraná (Unioeste). Data collection was due to the application of the "Job Stress Scale" (JSS) and in its reduced version adapted to Portuguese. The survey sample consisted of 44 individuals. Statistical analysis was correlated inversely with medium intensity (r = -0.404) between age and social support. For males was found between control and age (r = 0.603). According to the data obtained, we conclude that most workers are exposed to passive work, leading to loss of skills or disinterest in the job. This study highlights the importance of research in the area and the need for new actions that change the conditions of stress at work.     

The binomial work-health in the transit of Curitiba city

The working activity in traffic of the big cities complex interacts with the environment is often in unsafe and unhealthy imbalance favoring the binomial work - health. The aim of this paper was to analyze the relationship between work and health of taxi drivers in Curitiba, Brazil. This cross-sectional observational study with 206 individuals used a questionnaire on the organization's profile and perception of the environment and direct observation of work. It was found that the majority are male, aged between 26 and 49 years and has a high school degree. They are sedentary, like making a journey from 8 to 12 hours. They consider a stressful profession, related low back pain and are concerned about safety and accidents. 40% are smokers and consume alcoholic drink and 65% do not have or do not use devices of comfort. Risk factors present in the daily taxi constraints cause physical, cognitive and organizational and can affect your performance. It is concluded that the taxi drivers must change the unhealthy lifestyle, requiring a more efficient management of government authorities for this work is healthy and safe for all involved.     

Effects of long-acting testosterone undecanoate on bone mineral density in middle-aged men with late-onset hypogonadism and metabolic syndrome: results from a 36 months controlled study

We evaluated the effects of long-term testosterone replacement therapy (TRT) on the bone mineral density (BMD) in obese patients with metabolic syndrome (MS) and late-onset hypogonadism (LOH). Sixty men (mean age 57 ± 10) with low serum testosterone (T < 320 ng/dL) and MS regardless the presence of osteoporosis were enrolled. Forty men received intramuscular T-undecanoate (TU) four times/year for 36 months and 20 age-matched hypogonadal men with MS in whom T treatment was contraindicated were used as controls. Hormonal, biochemical markers, vertebral and femoral BMD by dual-energy x-ray absorptiometry were measured. At baseline, overall patients had mild osteopenia (lumbar BMD= 0.891 ± 0.097 g/cm(2); femoral BMD= 0.847 ± 0.117 g/cm(2)). TU induced a significant improvement of bone mass after 36 months (lumbar BMD=1.053 ± 0.145 g/cm(2); p < 0.002; femoral BMD=0.989 ± 0.109; p < 0.003 g/cm(2)) with a 5%/year increase and a significant reduction in hs-CRP without changes in body mass index. A direct relationship between serum T and BMD increments at the lumbar (r(2)?= 0.66, p < 0.0001) and femoral (r(2)?=0.52, p < 0.0001) sites was demonstrated. Study adherence was 50% without serious side effects. Long-term TRT in middle-aged men with LOH and MS determines a significant increase in both vertebral and femoral BMD related to increased serum T levels, probably independently from estradiol modifications.     

Research on persistent pain in late life: current topics and challenges

Older women often experience pain in their daily lives. This article provides an overview of topics addressed in the geriatric pain research published between 1999 and 2004. New areas of emphasis of research have emerged such as the recognition of body mass and weight as a factor in persistent pain, while other areas have expanded, including the focus on pain among elders with cognitive impairments and the use of alternative treatment approaches. Understanding of pain in late life is hindered by study samples that lack diversity, treatment approaches that are narrowly focused, and a lack of attention to quality of life issues.