Group benefit and protection of pediatric research subjects: Grimes v. Kennedy Krieger and the Lead Abatement Study

The Maryland Court of Appeals in Grimes v. Kennedy Krieger Institute was sharply critical of the lead abatement study conducted by this Institute, an affiliate of Johns Hopkins University. Grimes ruled that investigators might, given the facts of the case, have a special relationship with subjects, thereby creating a duty of care that could, if breached, give rise to an action in negligence. This ruling has implications for pediatric research practices and long-standing disputes among informed people of good will about what pediatric studies should be permitted.     

Comfort and Confidence Levels of Health Care Professionals Providing Pediatric Palliative Care in the Intensive Care Unit

ABSTRACT

Most childhood deaths that occur in the hospital happen in the pediatric intensive care unit. Providing pediatric palliative care in the intensive care unit comes with unique challenges due to the acute care, curative and often medically aggressive focus of these settings. In this study, 190 PICU health care professionals reported on their comfort and confidence in providing palliative care. Findings indicate that professionals report only a moderate level of comfort and confidence in this type of care in the pediatric ICU. For physicians and nurses, comfort and confidence was significantly higher for those who had practiced 8 years or more. Practitioners reported less comfort in providing psychosocial care. Implications for the social work role on the interdisciplinary team and suggestions for future research are discussed.     

The Institute for Senior Action

Abstract

Since 1977, the Joint Public Affairs Committee for Older Adults (JPAC) has been educating and mobilizing older adults to take an active role in the public policy decisions affecting their lives. Recognizing the need to better train its members in the techniques of social action and in an effort to familiarize recent retirees with the world of senior advocacy, JPAC founded a comprehensive leadership training program called the Institute for Senior Action in 1994. JPAC's 10-week training Institute integrates critical aging policy issues with practical grassroots applications for action. In addition to honing the skills of longtime community activists, the Institute serves as a vehicle for recent retirees and others to become more involved in social action.     

Testing drugs in pediatric populations: The FDA mandate

On November 27, 1998 the Food and Drug Administration (FDA) issued a new rule requiring that drugs and biological products be tested in pediatric populations. Since voluntary testing in pediatric populations had not resulted in a significant increase in pediatric labeling of drugs, stronger measures were needed to ensure that infants and children would receive the benefits of properly tested drugs and biologies. The mandate for pediatric testing raises a core ethical question: How should the need for validated treatments that benefit children as a group be weighed against the obligation to protect individual child subjects of research? The preamble to the new rule claims that adherence to Department of Health and Human Services (DHHS) and American Academy of Pediatrics (AAP) guidelines will provide adequate protection to individual subjects. Yet the special protections provided to children in these guidelines are not required by the new FDA rule, and have never been obligatory for research that is regulated by the FDA. While the new rule does not necessitate or encourage violation of these standards, the rule does not pay adequate attention to them nor clarify what role they should play in IRB review of protocols under FDA regulation.     

Central Ethical Dilemmas in Research Involving Children

We are obligated to protect individual child subjects of research, yet it is also necessary to investigate the safety and efficacy of medical treatments that benefit children as a class. The federal regulations on research with children have provided ethical guidance since 1983, but divergent interpretations persist. Since varying interpretations can lead to confusion and abuses, efforts are underway to clarify the criteria. Clarity is needed to protect individual child subjects from harm while enabling ethical research to proceed. The "pediatric rule" and the "pediatric exclusivity" incentive are important policy initiatives for promoting sound research on the medical treatment of children.     

Pediatric Palliative and End-of-Life Care

Abstract

Pediatric oncology social workers are often engaged in the psychosocial care of dying children and their families. Despite their participation on the interdisciplinary team, the role for social work in pe-diatric palliative and end-of-life care has not been clearly defined. This survey of 131 pediatric oncology social workers identified current and best social work practices for care of children and their families at the end of life. Implications for practice, education, and research are discussed.     

Evaluation of a Support Group for Parents of Children Hospitalized for Cancer and Hematopoietic Stem Cell Transplantation

ABSTARCT

Social isolation and high levels of psychosocial stress are common among parents of children who are hospitalized for cancer treatment. Many hospital-based programs offer support groups for parents, however there is little published guidance or systematic evidence on their effectiveness. This study describes the development and program evaluation of a 16-week parent support group offered to parents (N = 10) of children hospitalized for pediatric cancer or bone-marrow transplant. A summary of the pilot evaluation is provided and successes, barriers, and areas for future improvement are discussed.     

Book review

Living Together: Towards Inclusive Communities by Michelle Thompson‐Fawcett and Claire Freeman ed. Otago University Press, Dunedin. 2007. 240 p. NZ$39.95 (paperback). ISBN 1877372293.

Standing Upright Here: New Zealand in the Nuclear Age 1945–1990 by Malcolm Templeton. Victoria University Press in association with The New Zealand Institute of International Affairs, Wellington. 2006. 400 p. $NZ49.95 (paperback). ISBN 0864735405     

Demographic and Welfare State Predictors of Out-of-Pocket Health Expenditures: A Path Analytic Model

ABSTRACT

Out-of-pocket (OOP) payments are principal components of financing healthcare and have a significant effect on poverty in numerous developing countries. The present study seeks to ascertain the relation among demographic, welfare state, and OOP health expenditure indicators using a path analysis. National representative household budget data from the Turkish Statistical Institute for 2015 were used. To test the goodness of fit of the model, multiple fit indices were utilized. The model fit for redefined path analytic model data was good (X²/df = 70.20/9 = 7.8; RMSEA = 0.032; GFI = 1.00; AGFI = 0.99; CFI = 0.99). The results of the analysis revealed that demographic and welfare indicators are causally related to OOP health expenditures, and income was a mediating factor for this interrelationship. Designing of socially inclusive policies on the basis of the values of equity is essential to combat poverty due to OOP health expenditures in developing countries.     

Why the tolerance of potential harms? Research ethics in Alzheimer disease

This article summarizes the history of presentations to the National Bioethics Advisory Commission (NBAC) by representatives of the Alzheimer's Disease and Related Disorders Association, Inc., on the topic of human subjects research ethics. The interactions between these two bodies presents a useful profile of a public commission and a voluntary association working to clarify issues of great importance to the association's constituency. The context of epidemiology and ongoing research is also briefly presented. The author is a member of the Alzheimer's Disease and Related Disorders Association, Inc., National Ethics Advisory Panel, and in that role presented the Association position before NBAC and at the Friends Research Institute conference.     

Book review

Evidence‐based Policy: A Realist Perspective by Ray Pawson. Sage Publications, London. 2006. 208 p. NZ$98.99 (paperback). ISBN 1412910606.

The Handbook of Public Affairs edited by Phil Harris and Craig Fleisher. Sage Publications, London. 2005. 616 p. NZ$329.99 (hardback) ISBN 0761943935.

From Innocents to Agents: Children and Children's Rights in New Zealand by Michael Reid. Maxim Institute, Auckland. 2006. 279 p. NZ$39.90 (paperback). ISBN 0958265259.     

Problems of points of inflection in trend functions as described by a model for the forecast of brand shares

Trends often have special points of uncertainty (surprises) which make forecasts by trend extrapolation impossible. Such points of uncertainty are found especially at points of inflection of functions. In many cases it will be possible to decompose the trend to be forecast into two or more (causal) time series which have no points of inflection. By extrapolating these individual time series it will then be possible to predict the trajectory of the trend function inclusive of the point of inflection. This method is represented and critically discussed by means of an example for the forecast of a brand share.Werner Kroeber-Riel, Dr. rer. pol., is full professor of business and head of the Institute for Research in Consumption and Behavior at the University of the Saar in Saarbrücken.Sighard Roloff is a certified mathematician and assistant at the Institute for Research in Consumption and Behavior at the University of the Saar in Saarbrücken.This contribution first appeared under the title: Zur Problematik von Wendepunkten in Trendfunktionen, dargestellt an einem Modell zur Prognose von Marktanteilen, Zeitschrift für betriebswirtschaftliche Forschung 24 (1972) 294–300.     

A Different Kind of Holding Environment: A Case Study of Group Work with Pediatric Staff

ABSTRACT

This paper reports a nearly two-year intervention with staff at a major urban pediatric facility. The authors worked as trainers and consultants for two groups–the Emergency Department (ED) and Chronic Care units (CC). Following two days of training about grief and loss, highlighting skill building for work with traumatized and grieving children and parents, the consultants worked to develop teams which could provide a Winnicottian holding environment for staff. The efficacy of this staff training is analyzed and support needs of staff members are identified. Findings include varied willingness to make use of group support. Chronic care participants are more likely to express willingness to engage in on-going support for one another, while ED staff members seem to prefer structured, educational training and episodic support. The holding environment of the processing groups must be adapted to fit the needs of the medical sub-culture.     

Stillbirth: The Mother's Experience and Implications for Improving Care

ABSTRACT

More children die as a result of stillbirth than all other causes of infant deaths combined (Ananth, Shiliang, Kinzler, and Kramer, 2005; Goldenberg, Kirby, and Culhane, 2004; Froen, 2005; National Institute of Health, 2004); yet, mothers experiencing stillbirth are often left without support afterwards (Kubler-Ross, 2004; Fahey-McCarthy, 2003; Fletcher 2002; Saddler, 1987; DeFrain, 1986; Kirkley-Best & Kellner, 1982). Despite social work's growing involvement in care at the end of life, parents of stillborn children have not experienced consistent, relevant, and competent professional care in coping with the tragedy of death. Forty-seven women between the ages of 19 and 51 were recruited through nonprofit agencies that provide bereavement care to grieving families. Results of this qualitative study suggest that stillbirth is emotionally complex with long-lasting symptoms of grief and significant struggles to find meaning. The findings also support the need for perceived psychosocial and spiritual support from professional caregivers, family, and friends. The women's own experiences argue for comprehensive approaches to support the grief and loss of stillbirth, and for the importance of social work involvement in both immediate and longer term interventions.     

Extreme Copulas and the Comparison of Ordered Lists

We introduce two extreme methods to pairwisely compare ordered lists of the same length, viz. the comonotonic and the countermonotonic comparison method, and show that these methods are, respectively, related to the copula T _M (the minimum operator) and the Ł ukasiewicz copula T _L used to join marginal cumulative distribution functions into bivariate cumulative distribution functions. Given a collection of ordered lists of the same length, we generate by means of T _M and T _L two probabilistic relations Q ^M and Q ^L and identify their type of transitivity. Finally, it is shown that any probabilistic relation with rational elements on a 3-dimensional space of alternatives which possesses one of these types of transitivity, can be generated by three ordered lists and at least one of the two extreme comparison methods.     

Relationship Between Pain and Chronic Illness Among Seriously Ill Older Adults: Expanding Role for Palliative Social Work

Confronting the issue of pain among chronically ill older adults merits serious attention in light of mounting evidence that pain in this population is often undertreated or not treated at all (Institute of Medicine, 2011 Institute of Medicine . ( 2011 ). Relieving pain in America: A blueprint for transforming prevention, care, education and research . Washington, DC : National Academies Press . [Google Scholar]). The relationship between pain and chronic illness among adults age 50 and over was examined in this study through the use of longitudinal data from the University of Michigan Health and Retirement Study, sponsored by the National Institute on Aging and the Social Security Administration. Findings suggested positive associations between pain and chronic disease, pain and multimorbidity, as well as an inverse association between pain and education. Policy implications for workforce development and public health are many, and amplification of palliative social work roles to relieve pain and suffering among seriously ill older adults at all stages of the chronic illness trajectory is needed.     

Psychological Vulnerability and Gambling in Later Life

ABSTRACT

Objectives: Because behavioral problems often emerge from maladaptive coping methods, we investigated whether unmet basic psychological needs evolve toward a level of psychological vulnerability that puts older adults who gamble at risk for becoming problem gamblers. Methods: Data from a community sample of 379 adults ages 60 and above were analyzed using structural equation modeling. Participants responded to items regarding their demographics, gambling frequency, engagement in at-risk gambling behaviors, and the extent to which their basic psychological needs were met. Results: Satisfaction of basic psychological needs among older adults who gamble was negatively associated with their being at risk for developing a gambling problem. Satisfaction of basic psychological needs also mediated the negative effect of socioeconomic status on at-risk gambling behavior. Conclusion: Social workers should become mindful of how older adults, who are confronting psychological vulnerabilities in later life, might well turn to gambling as a maladaptive coping mechanism.As per journal style, abstract must not exceed100 words. Please amend accordingly.     

Research ethics and clinical trials: Fostering collaboration with research participants

Accountability in research is a concept that applies to researchers and study participants alike. Human subjects play an active part in the success or failure of a clinical trial by virtue of their understanding of a study's goals expectations of personal gain, and adherence to study design. Trials must be designed to address patient concerns, offer an improved consent process, and move beyond our narrow conception of “patient rights.”; Problems with protocol adherence may be reduced by conceptualizing clinical research as an endeavor with mutual accountability within a relational ethic.     

Statistics and the Public Sphere. Numbers and the People in Modern Britain,c. 1800–2000

Susan Elizabeth Ramírez, The World Upside Down. Cross‐Cultural Contact and Conflict in Sixteenth‐Century Peru (1996), vii + 234 (Stanford University Press, Stanford, £45.00).

Biography Database, 1680–1830: Personal Edition (1997; a rerelease of the 1995 institutional edition with updated software) (Romulus Press Ltd with the University of Newcastle upon Tyne, 91.83/$125).

Martin Hewitt, The Emergence of Stability in the Industrial City: Manchester, 1832–67 (1996), ix + 335 (Scolar Press, Aldershot, £45.00/$74.95).

Louise Young, Japan's Total Empire: Manchuria and the Culture of Wartime Imperialism (1998), xiii + 487 (University of California Press, Berkeley, £35.00/$45.00).

Kevin Passmore, From Liberalism to Fascism: The Right in a French Province, 1928–1939 (1997), xvii + 333 (Cambridge University Press, Cambridge, £40.00/$59.95).     

Experiences of Caregivers in a Dementia Simulation Program

Abstract

Objectives: Simulation-based training has been used in health care to increase clinical knowledge and skills and understanding the experience of others. There is a lack of research in exploring experiences of caregivers of people with dementia in a dementia simulation program and its potential benefits on caregivers. The purpose of this qualitative study was to explore experiences of caregivers of people with dementia who participated in a dementia simulation program, called Dementia Live?.

Methods: Fourteen caregivers were interviewed after participation in DL, and thematic analysis using NVivo 11 software was used.

Results: Three themes emerged, including: (i) the Dementia Live? as an eye-opening experience; (ii) the perceived benefits of the Dementia Live? on themselves; and (iii) recommendation of the Dementia Live? to other caregivers.

Conclusions: Dementia simulation programs such as the Dementia Live? may help caregivers to have more empathy, understand better about the behaviors and feelings of people with dementia, and to use strategies that can help when working with people with dementia. Further experimental research is needed to examine effectiveness of the dementia simulation program on caregivers and people with dementia.