INFLATE : a protocol for a randomised controlled trial comparing nasal balloon autoinflation to no nasal balloon autoinflation for otitis media with effusion in Aboriginal and Torres Strait Islander children

Background: Otitis media with effusion (OME) is common and occurs at disproportionately higher rates among Indigenous children. Left untreated, OME can negatively affect language, development, learning, and health and wellbeing throughout the life-course. Currently, OME care includes observation for 3 months followed by consideration of surgical ventilation tube insertion. The use of a non-invasive, low-cost nasal balloon autoinflation device has been found beneficial in other populations but has not been investigated among Aboriginal and Torres Strait Islander children. Methods/design: This multi-centre, open-label, randomised controlled trial will determine the effectiveness of nasal balloon autoinflation compared to no nasal balloon autoinflation, for the treatment of OME among Aboriginal and Torres Strait Islander children in Australia. Children aged 3–16 years with unilateral or bilateral OME are being recruited from Aboriginal Health Services and the community. The primary outcome is the proportion of children showing tympanometric improvement of OME at 1 month. Improvement is defined as a change from bilateral type B tympanograms to at least one type A or C1 tympanogram, or from unilateral type B tympanogram to type A or C1 tympanogram in the index ear, without deterioration (type A or C1 to type C2, C3, or B tympanogram) in the contralateral ear. A sample size of 340 children (170 in each group) at 1 month will detect an absolute difference of 15% between groups with 80% power at 5% significance. Anticipating a 15% loss to follow-up, 400 children will be randomised. The primary analysis will be by intention to treat. Secondary outcomes include tympanometric changes at 3 and 6 months, hearing at 3 months, ear health-related quality of life (OMQ-14), and cost-effectiveness. A process evaluation including perspectives of parents or carers, health care providers, and researchers on trial implementation will also be undertaken. Discussion: INFLATE will answer the important clinical question of whether nasal balloon autoinflation is an effective and acceptable treatment for Aboriginal and Torres Strait Islander children with OME. INFLATE will help fill the evidence gap for safe, low-cost, accessible OME therapies. Trial registration: Australia New Zealand Clinical Trials Registry ACTRN12617001652369. Registered on 22 December 2017. The Australia New Zealand Clinical Trials Registry is a primary registry of the WHO ICTRP network and includes all items from the WHO Trial Registration data set. Retrospective registration.</p

Laying the foundation for a developmental evaluation of the Omidyar Fellows Program, cohort I

D.Ed. University of Hawaii at Manoa 2014.Includes bibliographical references.The Omidyar Fellows Program's theory of change envisioned the creation of a community of leaders through which innovative and adaptive interventions are implemented in dynamic, interconnected island environments, and transform the State of Hawaiʻi. Pre-developmental or formative evaluation activities provided feedback on this system change initiative to enable adaptation and change. Evaluation data in two major groups, program and cohort impact, were collected and analyzed over the course of the 15-month program and six month post program periods. Consistent with the developmental evaluation approach, the evaluator took on the perspective, lens and context of an "insider" despite Fellow perceptions as a 3rd party. Two primarily utilitarian work products were produced: (a) a formative evaluation of the program near term impacts on Cohort I, including analyses of program design elements and activities and impacts of such program design on Cohort I; and (b) a program formative evaluation framework in which subsequent program, including cohort, data can be collected and analyzed for short (by cohort), mid (three to five years) and long term (five plus years) developmental evaluative learning and adaptation. The foundation laying or predevelopmental evaluation approach and work products supported program leadership's evaluative learning in responding to program posed key questions; assessed program alignment and the fidelity of implementing program design elements and activities; developed adaptive considerations in support of transformative, social innovation; and implemented adaptive program and initiative management

Randomised clinical trial research within Aboriginal and Torres Strait Islander primary health services : A qualitative study

Objective To better understand how to undertake valuable, ethical and sustainable randomised controlled clinical trial (RCT) research within Aboriginal and Torres Strait Islander primary health services. Design In a qualitative approach, we utilised data collected between 2013 and 2020 during the planning and implementation of two RCTs. The data comprised agreed records of research meetings, and semistructured interviews with clinical trial stakeholders. The stakeholders were parents/carers of child participants, and site-based research officers, healthcare providers and community advisory groups. Our thematic analysis was informed by constructivist grounded theory. Setting The RCTs investigated the management of otitis media in Aboriginal and Torres Strait Islander children, with the first RCT commencing recruitment in 2014 and the second in 2017. They took place in Aboriginal Medical Services (AMSs), large primary health services for Aboriginal and Torres Strait Islander people, based in urban and regional communities across two Australian states and one territory. Results We analysed data from 56 meetings and 67 interviews, generating themes on making research valuable and undertaking ethical and sustainable RCTs. Aboriginal and Torres Strait Islander leadership, and support of AMSs in their service delivery function were critical. The broad benefits of the trials were considered important to sustainability, including workforce development, enhanced ear healthcare and multidirectional research capacity building. Participants emphasised the long-term responsibility of research teams to deliver benefits to AMSs and communities regardless of RCT outcomes, and to focus on relationships, reciprocity and creating positive experiences of research. Conclusion We identify principles and strategies to assist in undertaking ethical and sustainable RCTs within Aboriginal and Torres Strait Islander primary health services. Maintaining relationships with AMSs and focusing on mutual workforce development and capacity building creates opportunities for long-term benefits so that health research and RCTs work for Aboriginal and Torres Strait Islander peoples, services, communities and researchers. Trial registration number ACTRN12613001068752 (Pre-results); ACTRN12617001652369 (Pre-results). </p

Effective workforce planning: understanding final year nurse and midwifery students’ intentions to migrate after graduation

Aims To examine the factors influencing final‐year nursing/midwifery students’ intentions to migrate following graduation. Background With expanding global staff shortages, effective recruitment and retention strategies targeted at new nursing/midwifery graduates are necessary. Understanding factors that influence graduates’ decisions to migrate or remain in the health care organisation that supported their education is essential but under‐researched. Methods A cross‐sectional electronic survey was distributed to graduating nursing/midwifery students across nine higher education institutions in Ireland with a 36% (N = 407) response rate. Results 85% of Irish (n = 376) nursing/midwifery graduating students reported an intention to migrate overseas and 70% intend to return within 5 years. Pay, working conditions and career were ranked as influencing intentions to migrate. Multivariable analysis illustrated that educational opportunities and friends predict migration, while family and obligation were protective factors. Conclusion Nursing and midwifery leaders and policymakers must reconsider recruitment and retention strategies and embrace innovative and responsive approaches to address migration intentions and trends. Implications for nursing/midwifery management Strategic leadership is required to develop effective structures that support personal, professional and career opportunities for new graduates. Targeted recruitment innovations to entice graduates back into the health service are recommended

Hyperbaric oxygen treatment of chronic refractory radiation proctitis: A randomized and controlled double-blind crossover trial with long-term follow-up

Purpose: Cancer patients who undergo radiotherapy remain at life-long risk of radiation-induced injury to normal tissues. We conducted a randomized, controlled, double-blind crossover trial with long-term follow-up to evaluate the effectiveness of hyperbaric oxygen for refractory radiation proctitis