The use of external controls: To what extent can it currently be recommended?

With more and better clinical data being captured outside of clinical studies and greater data sharing of clinical studies, external controls may become a more attractive alternative to randomized clinical trials (RCTs). Both industry and regulators recognize that in situations where a randomized study cannot be performed, external controls can provide the needed contextualization to allow a better interpretation of studies without a randomized control. It is also agreed that external controls will not fully replace RCTs as the gold standard for formal proof of efficacy in drug development and the yardstick of clinical research. However, it remains unclear in which situations conclusions about efficacy and a positive benefit/risk can reliably be based on the use of an external control. This paper will provide an overview on types of external control, their applications and the different sources of bias their use may incur, and discuss potential mitigation steps. It will also give recommendations on how the use of external controls can be justified.     

Risk of physical assault against school educators with histories of occupational and other violence: a case-control study

A case-control study design was used to investigate risks of work-related physical assault (PA) associated with a history of violent victimization among educators. A total of 6,469 state-licensed educators (Kindergarten - Grade 12) worked in the previous 12~months and were eligible to participate. Exposure data were collected from cases (reporting a PA event in previous 12 months, n=290) for the month before PA, and from controls (no work-related PA in previous 12 months; n=867) for a randomly selected working month. Odds ratios and 95% confidence intervals identified increased risks for educators with any prior history of work-related (17.3, 11.4-26.3) or non-work-related PA (2.0, 1.2-3.5). In addition, PA risk in the previous twelve months increased with the number of previous victimizations, and risk also increased for educators with histories of non-physical violence (work- and non work-related). The results present a compelling case for targeted interventions and further research.     

Family Therapy Practitioners Researching the Reactions of Practitioners to an Outcome Measure

Family therapy is under increasing pressure to use ‘objective’ measures of effectiveness, but there are strong voices in the field objecting to such research. The primary objective of this project was to investigate the acceptability and perceived potential usefulness of a short self‐report questionnaire. A secondary objective was to explore the viability of conducting such research by a group of practitioners who would collaborate primarily through emails. Nine experienced family therapists were interviewed as they worked through the 16 items of a pilot version of the SCORE questionnaire. The recorded interviews were analysed using Template Analysis. The SCORE was found to be generally acceptable for use with clients but the exercise generated information on a variety of concerns about the content of the measure. Beyond its potential as an outcome measure there was considerable interest in how it could be used therapeutically. The operation of the Practitioner Research Network proved functional but indicated some of the difficulties that such networks might encounter.     

Mental health service users' experiences of returning to paid employment

Research into mental health and employment has focused largely on people who are unemployed. This paper reports the experiences of 20 clients of employment support agencies who had succeeded in returning to work. A number of barriers to getting back to work were identified, but receiving employment support could enable people to overcome them. There was consistency with previous studies of factors associated with high and low levels of job satisfaction. Even those participants who were less satisfied with their jobs identified benefits and none described any negative effects. The quality of the employment support provided was important, including advice and counselling during the job search, enabling informed choice about disclosure and support in work. Job retention targets are required for funding programmes in addition to placement targets. Further research into the timing and processes of disclosure and into occupational health screening processes would be helpful.     

Play in Middle Childhood: Everyday Play Behaviour and Associated Emotions

Children's reports about their play in middle childhood and the emotions they associate with play have received limited research attention. Using focus groups, this study asked 38 children in the UK about what, where and with whom they played. They were also asked how play made them feel. Children reported a wide range of play behaviours, with outdoor and traditional games being just as prominently mentioned as play with electronic devices. The emotional importance of play in middle childhood was apparent, with children associating play with strong positive emotions, and not being able to play with negative emotions and anxiety.     

Enriching our understanding of vulnerability through the experiences and perspectives of individuals living with mental illness

ABSTRACT

Vulnerability is a central concept in research ethics and typically serves to identify individuals or groups whose participation in research prompts specific concerns or warrants special consideration. While theoretical discussions on vulnerability have contributed valuable insights to discussions of mental health research and care, they have not been enriched thus far by stakeholder perspectives. This oversight has important consequences for the ways in which we frame vulnerability. It misses the far-reaching insights and experiential knowledge of mental health research participants whose experiences this ethics concept ultimately seeks to capture. In view of this gap, our study combines a pragmatist ethics framework and interpretive phenomenological analysis of qualitative interviews to explore user perspectives on the notion of vulnerability through the lived experiences of mental health research participants and patient-advocates. Importantly, these perspectives offer essential clues to address the difficulties of operationalizing concerns for vulnerability in concrete and practical ways. They help refine our understanding of this key ethics concept.     

The Forgotten: Dementia and the Aging LGBT Community

Although research documenting the experience of lesbian, gay, bisexual, transgendered (LGBT) aging in general is gaining traction, and literature on dementia continues to proliferate, few articles attend to how dementia affects members of the aging LGBT community. This article reviews the current state of knowledge on the experience of dementia for LGBT older adults, and suggests areas for further research. In addition, it aims to promote social work’s engagement with related disciplines and global dementia care. The article’s ultimate goal is to encourage development of care practices tailored to the experiences, expectations and needs of older LGBT individuals affected by dementia.