ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes: protocol for the ELECTRIC randomised trial

Background Urinary incontinence (UI) is highly prevalent in nursing and residential care homes (CH) and profoundly impacts on residents’ dignity and quality of life. Care homes predominantly use absorbent pads to contain UI rather than actively treat the condition. Transcutaneous posterior tibial nerve stimulation (TPTNS) is a non-invasive, safe, low-cost intervention with demonstrated effectiveness for reducing UI in adults. However, the effectiveness of TPTNS to treat UI in older adults living in care homes is not known. The ELECTRIC Trial aims to establish if a programme of TPTNS is a clinically effective treatment for UI in care home residents and investigate the associated costs and consequences. Methods This is a pragmatic, multicentre, placebo controlled randomised parallel group trial comparing effectiveness of TPTNS (target n=250) with sham stimulation (target n=250) in reducing volume of UI in CH residents. CH residents (men and women) with self- or staff- reported UI of more than once per week are eligible to take part, including those with cognitive impairment. Outcomes will be measured at 6, 12 and 18 weeks post randomisation using the following measures: 24-hour pad weight tests (PWT), post void residual urine (bladder scans), Patient Perception of Bladder Condition (PPBC), Minnesota Toileting Skills Questionnaire (MTSQ) and Dementia Quality of Life (DEMQOL). Economic evaluation based on a bespoke Resource Use Questionnaire will assess the costs of providing a programme of TPTNS. A concurrent process evaluation will investigate fidelity to the intervention and influencing factors and qualitative interviews will explore the experiences of TPTNS from the perspective of CH residents, family members, CH staff and managers. Discussion TPTNS is a non-invasive intervention that has demonstrated effectiveness in reducing UI in adults. The ELECTRIC Trial will involve CH staff delivering TPTNS to residents and establish whether TPTNS is more effective than sham stimulation for reducing the volume of UI in CH residents. Should TPTNS be shown to be an effective and acceptable treatment for UI in older adults in CHs, it will provide a safe, low-cost and dignified alternative to the current standard approach of containment and medication. Trial registration Clinical Trials.gov. NCT03248362. Registered on 14/08/2017. https://clinicaltrials.gov/ ISRCTN, ISRCTN 98415244. Registered on 25/04/2018. https://www.isrctn.com

Someone is watching you: The ethics of using covert observation to explore adult behaviour at children's sporting events

Simon R. Walters, and Rosemary Godbold, 'Someone Is Watching You: The Ethics of Covert Observation to Explore Adult Behaviour at Children’s Sporting Events', Journal of Bioethical Inquiry, Vol. 11 (4): 531-537, July 2014, doi: https://doi.org/10.1007/s11673-014-9543-2. Published by Springer Netherlands. © Springer Science+Business Media Dordrecht 2014.Concerns have been expressed about adult behaviour at children’s sporting events in New Zealand. As a consequence, covert observation was identified as the optimal research method to be used in studies designed to record the nature and prevalence of adult sideline behaviour at children’s team sporting events. This paper explores whether the concerns raised by the ethics committee about the use of this controversial method, particularly in relation to the lack of informed consent, the use of deception, and researcher safety, were effectively managed. This is achieved by reflecting on the conduct and findings of the research and by drawing on the perspectives of research assistants who carried out the covert observation. The authors argue that in the context of these studies, the ends have justified the means and with careful attention to the design of the study the complex ethical tensions arising from the use of this method can be managed.Peer reviewe