Use of the metastatic breast cancer progression (MBC-P) questionnaire to assess the value of progression-free survival for women with metastatic breast cancer.

While overall survival (OS) has historically been the primary endpoint for clinical trials in oncology, progression-free survival (PFS) has gained acceptance as a valuable surrogate endpoint. However, there are no known published reports about the value of PFS from the patient's perspective. We developed a questionnaire that included items regarding quality of life (QoL) and the importance of different treatment outcomes and presented hypothetical scenarios for which respondents were asked to indicate their preferences concerning treatments as they relate to PFS. 282 women with metastatic breast cancer (MBC), ranging in age from 21 to 80 years completed an online version of this questionnaire. The majority of women (66 %) had been diagnosed with MBC within the previous 3 years and 56 % had been told their MBC had progressed. When asked to rank five treatment characteristics from most important to least important, respondents ranked "extending PFS" as the second most important treatment outcome after OS. When presented with a hypothetical scenario of two women receiving different treatments, respondents preferred the treatment that resulted in longer PFS (16 vs. 12 months), even when OS and side effects were assumed to be equal. Specifically, when asked to consider which woman within the hypothetical scenario had better QoL, physical functioning, and emotional well-being, respondents more often chose the woman who experienced longer PFS (QoL: 40 vs. 6 %; physical functioning: 32 vs. 8 %; emotional well-being: 58 vs. 6 %) compared to the woman within the hypothetical scenario who had a shorter time of progression. Respondents rated their own QoL highest after being told their MBC was responding to treatment (mean score 76.6) versus after the initial diagnosis of breast cancer and MBC (68.5 and 60.3). These findings suggest that extending PFS is an important treatment outcome and, from a patient perspective, improves overall QoL, physical functioning, and emotional well-being

The Unification of Journalism and Communication Studies: The Benefits of Change

The article discusses the advantages, implications and the feasibility of integrating journalism and communication studies. The authors comment that the fear of academic merger has prevented the integration of journalism and communication studies. According to them, school employees believe that integrating journalism and communication departments will result to lay-offs. Integrating the two studies is expected to increase the communication skills of journalism students and enhance literary skills of communication students

Measurement properties of the Flu-Like Symptom Index from the Hepatitis Physical Symptom Severity Diary

Purpose Chronic Hepatitis C (CHC) Virus infection is a serious health issue in the US. Standard treatment involves peginterferon alpha and ribavirin, often associated with adverse side effects including flu-like symptoms. These adverse effects are common reasons for the discontinuation of treatment and therefore represent a major obstacle in the effective treatment of CHC. Methods The Hepatitis Physical Symptom Severity Diary, a newly developed patient-reported outcome mea-sure for assessing physical symptoms in CHC patients, was recently developed. It contains four questions addressing flu-like symptoms [the Flu-Like Symptom Index (FLSI)]. Measurement properties of the FLSI in CHC patients were assessed using data from two randomized clinical trials. Results Exploratory factor analysis using data from baseline and the last visit while on treatment supported a single-factor solution for the FLSI. Internal reliability and test–retest reliability are acceptable (Cronbach’s alpha range 0.73–0.81; intraclass correlation coefficient range 0.85–0.97), and correspondence to several similar con-structs was acceptable. The FLSI score was higher among those with investigator-reported flu-like symptoms (mean = 4.1) versus those without (1.4), although not statistically significant (p = 0.12). Responsiveness of the FLSI was moderate, as measured by standardized effect sizes and response means, and the minimum important difference (MID) was estimated at 2.5–3.0 points. Conclusions While additional research should be con-ducted to evaluate validity with more closely related con-structs and to utilize anchor-based methods for estimating the MID, data suggest that the FLSI has acceptable mea-surement properties and can be an effective tool in assessing flu-like symptoms in CHC patients

The double-edged sword: Emotional regulation for children at risk.

Abstract: The capacity to manage emotion is based on the growth of self-regulatory capacities in the early years, but is also affected by situational demands, influences from other people, and the child's goals for regulating emotion in a particular setting. For most children growing up in supportive contexts, the growth of emotional regulation is associated with enhanced psychosocial wellbeing and socioemotional competence. But for children who are at risk for the development of psychopathology owing to environmental stresses or intrinsic vulnerability (or their interaction), emotional regulation often entails inherent trade-offs that make nonoptimal strategies of managing emotion expectable, perhaps inevitable, in a context of difficult environmental demands and conflicting emotional goals. This analysis discusses how emotional regulation in children at risk may simultaneously foster both resiliency and vulnerability by considering how emotion is managed when children (a) are living with a parent who is depressed, (b) witness or experience domestic violence, or (c) are temperamentally inhibited when encountering novel challenges. In each case, the child,s efforts to manage emotion may simultaneously buffer against certain stresses while also enhancing the child's vulnerability to other risks and demands. This double-edged sword of emotional regulation in conditions of risk for children cautions against using "optimal" emotional regulation as an evaluative standard for such children or assuming that emotional regulation necessarily improves psychosocial well-being. It also suggests how the study of emotional regulation must consider the goals for regulating emotion and the contexts in which those goals are sought. Article: Emotions are complex phenomena. They entail constellations of physiological arousal, cognitive appraisal, and expressive activity that interact with situational demands and cultural rules to create subtly nuanced, richly variable subjective and behavioral events. Individual differences in emotion are also multifaceted, fashioned from the interaction of organismic (e.g., temperamental) characteristics, experiential history, construals of oneself and the situation, and the personal goals that shape emotional arousal and its expression. Consequently, although emotion has its roots in the legacy of biological adaptation, it also reflects some of the most sophisticated features of human social cognition, self-understanding, and strategic functioning. It should be no surprise, therefore, that emotional regulation is a complex phenomenon. Although strategies of emotional self-regulation originate in the young infant's simple efforts to cope with distress through self-soothing, they quickly become integrated into a network o

Analysis of leachable Bis Di-tert-butyl Phenyl Phosphate (bdtbpp) in bioprocessing films

The analysis of extractable and leachable compounds from medical grade plastics is a complex issue that is compounded by the presence of many chemical species that are either direct or indirect reaction and/or degradation products of additives, process aids and polymer agents. These compounds may be present at various levels and the potential for adverse effects on cell growth remains to be determined and warrants further investigation. Since many of these films undergo aggressive processing steps, such as, thermal extrusion and gamma irradiation there is the potential for many unknown degradation products to be formed at each step of the processing. In addition, the absolute identification of many of these chemical compounds remains unknown. Within the various applications of single-use disposable bioprocessing, the presence of bis di-tert butyl phenyl phosphate (bDtBPP), a common gamma irradiation degradation product of tris (2,4-ditert-butylphenyl) phosphite (TBPP), has been shown to have a profoundly negative impact on cell growth for certain lines. The presence of bDtBPP even at low levels (on the order of 10ppb) has been shown to inhibit cell growth performance percentages in some lines by as much as 30-50% [1]. The quantitative analysis of this compound becomes increasingly difficult at lower levels due to either; 1) irreversible binding of strongly charged phosphate groups to glassware and other labware used in processing samples, or 2) hydrolytic degradation in aqueous solutions, or 3) any combination of the two. Losses from either of these conditions has been show to give rise to variations in quantitative analysis results as high as 50% when testing ranges are set between 5-100 parts per billion (ppb) in water. To this end, we have investigated the fate of this compound at part per billion levels to gain insight into possible mechanisms associated the variations observed. The hydrolytic degradation as well as irreversible binding to various substrates such as HPLC vials, pipette tips, etc. has been investigated extensively. We propose mitigation strategies which allow for low level quantitative analysis of this compound to achieve a coefficient of variation (CV) within the range of 10-20%, for bDtBPP in water within concentration ranges of 5-100 ppb. References Lindskog, Eva., Blank, Eva., Ullsten, Sara., Yi, Shujian., Ganguli, Pokon., Carter, Jeffrey., Parma, Hernan. Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers; BioPharm International, Volume 28, Issue 1, January 1, 2015

An Analysis of the Implications of the Stupak/Pitts Amendment for Coverage of Medically Indicated Abortions

This analysis examines the implications for coverage of medically indicated abortions under the Stupak/Pitts Amendment (Stupak/Pitts) to H.R. 3962, the Affordable Health Care for America Act. In this analysis we focus on the Amendment\u27s implications for the health benefit services industry as a whole. We also consider the Amendment\u27s implications for the growth of a market for public or private supplemental coverage of medically indicated abortions. Finally, we examine the issues that may arise as insurers attempt to implement coverage determinations in which abortion may be a consequence of a condition, rather than the primary basis of treatment