A comprehensive systematic review of stakeholder attitudes to alternatives to prospective informed consent in paediatric acute care research

Background: A challenge of performing research in the paediatric emergency and acute care setting is obtaining valid prospective informed consent from parents. The ethical issues are complex, and it is important to consider the perspective of participants, health care workers and researchers on research without prospective informed consent while planning this type of research. Methods: We performed a systematic review according to PRISMA guidelines, of empirical evidence relating to the process, experiences and acceptability of alternatives to prospective informed consent, in the paediatric emergency or acute care setting. Major medical databases and grey sources were searched and results were screened and assessed against eligibility criteria by 2 authors, and full text articles of relevant studies obtained. Data were extracted onto data collection forms and imported into data management software for analysis. Results: Thirteen studies were included in the review consisting of nine full text articles and four abstracts. Given the heterogeneity of the methods, results could not be quantitatively combined for meta-analysis, and qualitative results are presented in narrative form, according to themes identified from the data. Major themes include capacity of parents to provide informed consent, feasibility of informed consent, support for alternatives to informed consent, process issues, modified consent process, child death, and community consultation. Conclusion: Our review demonstrated that children, their families, and health care staff recognise the requirement for research without prior consent, and are generally supportive of enrolling children in such research with the provisions of limiting risk, and informing parents as soon as possible. Australian data and perspectives of children are lacking and represent important knowledge gaps

Supporting rural and remote area nurses to utilise and conduct research: an intervention study

Background:\ud Nurses are expected to embrace research and evidence-based practice but in rural/remote facilities it is particularly difficult to develop and utilise research skills.\ud \ud Objectives:\ud This collaborative study aimed to explore nurses' orientation to research and address known inhibitors to engagement with research in rural/remote north Queensland locations.\ud \ud Participants:\ud The sample comprised nurses from two rural/remote areas within a regional health service. Methods A pre-test post-test intervention study with two levels of data collection: responses to Edmonton Research Orientation Scale administered 3 times to all nurses, and number of research proposals developed. This intervention comprised provision of face-to-face workshops, paper-based resources, and informal videoconference, email and telephone contact.\ud \ud Results:\ud Survey response rates varied from 56% to 34%. Two-thirds of respondents were over 40 years old; 75% were Registered Nurses. One quarter rated understanding of journal articles as poor or very poor and 50% rated their knowledge of research similarly. However, 50% said research had changed the way they practiced. Older nurses, nurses with tertiary qualifications and those with senior appointments had more positive orientation to research scores. Several locally relevant research proposals were developed from one site; two received internal funding for further development and implementation. The intervention also led to increased utilisation of library resources which has continued past this study's end.\ud \ud Conclusions:\ud The variation in uptake between sites reinforces the need for locally targeted support. This study has gone beyond measuring research utilisation by including evaluation of support mechanisms to engage nurses in developing research proposals

The effects of continued smoking in head and neck cancer patients treated with radiotherapy: a systematic review and meta-analysis

Purpose: To determine the effects of continued smoking in head and neck cancer (HNC) patients undergoing radiotherapy on overall survival (OS), locoregional control (LRC), quality of life (QoL) and acute and late toxicities. Methods: Articles from January 1990 to August 14, 2018 were searched in PubMed, MEDLINE (Ovid), Embase, Scopus, The Cochrane Library, CINAHL and AUSThealth. Articles were included if majority of patients were treated with radiotherapy and smokers were defined as those who continued to smoke during or after radiotherapy. Data extraction and risk of bias assessment was performed by three independent co-authors using summary data of original studies. A meta-analysis using a random effects model was conducted for OS and LRC. In addition, a qualitative synthesis was performed for toxicities and quality of life as only a limited number of articles were available. Results: The initial search identified 2217 studies, with 24 articles comprising 6332 patients eligible for inclusion. Analysis demonstrated that continued smoking was associated with approximately two times the risk of mortality (RR = 1.85, 95% CI 1.55-2.21, p < 0.0001, I² = 43%) in HNC patients. Similarly, the risk of locoregional failure was more than two times greater in HNC patients who continued smoking (RR = 2.24, CI 1.42-3.52, p = 0.0005, I² = 64%). The qualitative synthesis indicates that continued smoking may contribute to an elevated incidence of late but not acute toxicities. Conclusions: This review provides evidence that continued smoking is associated with a lower OS and LRC and a higher incidence of late toxicities. Therefore, clinicians should strongly encourage smoking cessation amongst all head and neck cancer patients

Protocol: a comprehensive systematic review of alternatives to prospective informed consent in paediatric emergency research

There is a community expectation that children presenting to emergency departments receive the best possible care, and that decisions are based on high-level evidence. Clinical research in children is necessary for paediatric emergency medicine to continue to advance, but research in emergency settings is challenging. One of the many challenges researchers face in conducting emergency research is the difficulty of obtaining prospective informed consent in ED research, and this has historically been a barrier to conducting research in this setting. Guiding principles for use of alternatives to prospective informed consent in emergency research are outlined in the Declaration of Helsinki and in local documents such as the NHMRC National Statement on Ethical Conduct in Human Research which allows consent to occur after an intervention in certain circumstances. To ensure that ethical research can continue to be performed in this group, within the expatiations of the community, it is important to explore and understand the perceptions and experiences of parents, health care workers and researchers to alternatives to informed consent in paediatric emergency research