Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology.

OBJECTIVE: Adverse event (AE) monitoring is central to assessing therapeutic safety. The lack of a comprehensive framework to define and grade maternal and fetal AEs in pregnancy trials severely limits understanding risks in pregnant women. We created AE terminology to improve safety monitoring for developing pregnancy drugs, devices and interventions. METHOD: Existing severity grading for pregnant AEs and definitions/indicators of 'severe' and 'life-threatening' conditions relevant to maternal and fetal clinical trials were identified through a literature search. An international multidisciplinary group identified and filled gaps in definitions and severity grading using Medical Dictionary for Regulatory Activities (MedDRA) terms and severity grading criteria based on Common Terminology Criteria for Adverse Event (CTCAE) generic structure. The draft criteria underwent two rounds of a modified Delphi process with international fetal therapy, obstetric, neonatal, industry experts, patients and patient representatives. RESULTS: Fetal AEs were defined as being diagnosable in utero with potential to harm the fetus, and were integrated into MedDRA. AE severity was graded independently for the pregnant woman and her fetus. Maternal (n = 12) and fetal (n = 19) AE definitions and severity grading criteria were developed and ratified by consensus. CONCLUSIONS: This Maternal and Fetal AE Terminology version 1.0 allows systematic consistent AE assessment in pregnancy trials to improve safety.

Portraits of caregivers of end-stage dementia patients receiving hospice care.

The purpose of this study was to investigate how caregivers respond to the end stages of dementia with the assistance from hospice. Data were collected from 27 family caregivers over the course of 10 months, with each caregiver being interviewed up to 4 times during the time that the patient received hospice care. Chart review data were also collected. Four distinct caregiver portraits emerged: (a) disengaged; (b) questioning; (c) all-consumed; and (d) reconciled. Caregivers in each portrait differed in how they responded to the impending death of the care recipient, the disease progression, and hospice care. Recognizing the differences in the ways that caregivers respond to the final stages of the disease will assist hospice and other providers in best meeting the needs of the caregivers.

Roles, responsibilities, and relationships among older husbands caring for wives with progressive dementia and other chronic conditions.

Men are playing greater roles in the provision of care for older adults with chronic health conditions. Husbands, in particular, encounter many role transformations as they witness their wives grow in levels of dependence as a result of their illnesses. This qualitative study examines the changes that occurred in the roles, responsibilities, and relationships of 17 husbands who were providing care for their wives with memory loss and other chronic health conditions. The results suggest that husbands experience changes in the ways that they adapt their marital roles to the new roles they assume as caregivers. It was found that the husbands had to learn how to form new types of relationships with their ailing wives. Implications for geriatric social workers and other health care providers are discussed.

Dealing with the aftermath: a qualitative analysis of mental health social workers' reactions after a client suicide.

Social workers provide services to populations with mental health issues, including suicidal ideations and are thus at risk of experiencing a client suicide at some point during their career. Limited research using quantitative methods has explored the effect of client suicide on social workers, but little is known about their reactions from a qualitative standpoint-a method of study that is essential for fully understanding a social science phenomenon. This study addresses the gap in the literature by providing findings from an in-depth qualitative study of 25 mental health social workers who shared their experiences and reactions in the aftermath of a client suicide. Major themes were identified, including both professional and personal reactions of denial, anger, grief, and acceptance. Avoidance and intrusion, as well as additional themes of professional incompetence, responsibility, isolation, and justification were indicated and discussed in the conceptual framework of grief and secondary traumatic stress. The implications for practitioners, administrators, and educators are discussed.