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Background: Identifying and supporting young children who are at risk of developing anxiety disorders would benefit children, families, and wider society. Elevated anxiety symptoms, inhibited temperament, and high parental anxiety are established risk factors for later anxiety disorders, but it remains unclear who is most likely to benefit from prevention and early intervention programmes. Delivering an online intervention through schools to parents of young children who have one or more of these risks could maximise reach. The primary aim of this trial is to evaluate the effectiveness and cost-effectiveness of delivering an online parent-led intervention, compared with usual school provision only, for children (aged 4-7) identified as at risk for anxiety disorders on the basis of at least one risk factor. We also aim to identify the characteristics of children who do and do not benefit from intervention and mechanisms of change from the intervention., Methods: The design will be a parallel group, superiority cluster randomised controlled trial, with schools (clusters) randomised to intervention or usual school practice arms in a 1:1 ratio stratified according to level of deprivation within the school. The study will recruit and randomise at least 60 primary/infant schools in England, and on the basis of recruiting 60 schools, we will recruit 1080 trial participants (540 per arm). Parents of all children (aged 4-7) in sampled Reception, Year 1, and Year 2 classes will be invited to complete screening questionnaires. Children who screen positive on the basis of anxiety symptoms, and/or behavioural inhibition, and/or parent anxiety symptoms will be eligible for the trial. Parents/carers of children in schools allocated to the intervention arm will be offered a brief online intervention; schools in both arms will continue to provide any usual support for children and parents throughout the trial. Assessments will be completed at screening, baseline (before randomisation), 6 weeks, 12 weeks, and 12 months post-randomisation. The primary outcome will be the absence/presence of an anxiety disorder diagnosis at 12 months., Discussion: The trial will determine if delivering an online intervention for parents of young children at risk of anxiety disorders identified through screening in schools is effective and cost-effective., Trial Registration: ISRCTN 82398107 . Prospectively registered on Jan. 14, 2021., (© 2022. The Author(s).)

Ecological baselines for the structure and functioning of ecosystems in the absence of human activity can provide essential information on their health status. The Glorieuses islands are located in the Western Indian Ocean (WIO) and can be considered as "pristine" ecosystems that have not been subjected to anthropogenic pressure. Their nutrient context and the microbial assemblages were assessed by determining the abundance of heterotrophic prokaryotes (archaea and bacteria), picocyanobacteria, picoeukaryotes, microphytoplankton and protozooplankton communities in five stations, during two contrasted periods (November 2015 and May 2016). Chlorophyll-a concentrations were always under 1 μg/L and associated to very low levels in orthophosphates, nitrate and dissolved organic carbon, revealing an ultra-oligotrophic status for the Glorieuses waters. Picocyanobacteria confirmed the ultra-oligotrophic status with a predominance of Synechococcus. Zeaxanthin associated with the presence of picocyanobacteria represented the major pigment in both surveys. Three indices of diversity (species richness, Shannon and Pielou indexes) from microscopy observations highlighted the difference of diversity in microphytoplankton between the surveys. A focus on a 16S metabarcoding approach showed a high dominance of picocyanobacteria, Alpha- and Gammaproteobacteria, regardless of station or period. Multivariate analyses (co-inertia analyses) revealed a strong variability of ecological conditions between the two periods, with (i) high nutrient concentrations and heterotrophic nanoflagellate abundance in November 2015, and (ii) high heterotrophic prokaryote and picoeukaryote abundance in May 2016. The impact of a category 5 tropical cyclone (Fantala) on the regional zone in April 2016 is also advanced to explain these contrasted situations. Relative importance of top-down factors between bacterial and heterotrophic nanoflagellates was observed in November 2015 with an active microbial food web. All the results indicate that three microbial indexes potentially can be considered to assess the ecological change in Glorieuses marine waters., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Objective: Respectful maternity care is a pervasive human rights issue, but little is known about its realisation in Australia. Two scales, developed in North America, measure key aspects of respectful maternity care: the Mothers on Respect Index and Mothers Autonomy in Decision Making scale. This study aimed to validate these two scales in Queensland, Australia, and to determine the extent to which women currently experience respectful maternity care and autonomy in decision making., Design: A sequential two-phase study. A focus group reviewed the scales, made adaptations to scale items and completed a Content Validation Survey. The Respectful Maternity Care in Queensland survey, comprising the validated Australian scales and demographic questions was distributed online in early 2020., Setting: Queensland, Australia., Participants: Focus group involved women (n=10) who were aged over 18, English-speaking, and had given birth during the preceding two years. All women who had birthed in Queensland between September 2019 and February 2020, were eligible to participate in the cross-sectional survey. 161 women participated in the survey., Measurements and Findings: Item content validity (>0.78) was established for all but one item. Scale content validity was established for both scales (0.92 and 0.99 respectively). Survey participants (n= 161) were mostly married/partnered (95%), heterosexual (93%), tertiary educated (47%), Caucasian (88%), and had experienced a range of maternity models of care. Median scores on each scale (74 and 26 respectively) indicated that participants felt well respected and highly autonomous. Free-text comments highlighted the importance of relationship-based care., Key Conclusions: Both scales appear valid for use in Australia. Although most participants reported high levels of respect and autonomy, the proportion of participants who had experienced continuity of midwifery care was also high., Implications for Practice: Both scales could be routinely deployed as patient reported experience measures in Australia, broadening the data that informs maternity service planning and delivery., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Guidance is scarce on whether and how to involve parents in treatment for anxiety and depressive disorders in children and young people. We did a scoping review of randomised controlled trials of psychological interventions for anxiety and depressive disorders in children and young people, in which parents were involved in treatment, to identify how parents and carers have been involved in such treatments, how this relates to both child and broader outcomes, and where research should focus. We identified 73 trials: 62 focused on anxiety and 11 on depressive disorders. How parents were involved in treatments varied greatly, with at least 13 different combinations of ways of involving parents in the anxiety trials and seven different combinations in the depression trials. Including parents in treatment did not impair children's and young people's outcomes, but the wide variability in how they were involved prevents clarity about why some trials favoured parent involvement and others did not. Studies must consider the long-term and wider benefits beyond children's and young people's mental health, such as enhanced engagement, family wellbeing, and economic gains., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Objectives: To design, deliver and evaluate a programme of training workshops for biomedical researchers aimed at building confidence and skills in actively involving patients and the public (PPI) in research., Design: A bespoke programme of training workshops in PPI aimed at researchers., Setting: A large National Institute for Health Research Biomedical Research Centre in London and several partner organisations., Participants: 721 scientists, clinicians and research managers attending dedicated training in PPI at a major London NHS (National Health Service)-university partnership., Interventions: A programme of 72 training workshops, designed to build practical skills and confidence for researchers working with patients and the public in research, was delivered at a major research-active NHS:university partnership. An iterative approach was taken to the programme, with the content of the workshops continually reviewed and refreshed to respond to the needs of researchers. Surveys before, immediately following and 6 months after training investigated the impact on researchers' confidence and skills in PPI work, and the kind of PPI they subsequently carried out., Results: Training brought about immediate marked increases in researchers' self-reported confidence to carry out PPI activities within their research, and in their knowledge of good practice. The evaluation indicates that workshop attendees were more likely to involve patients in their research following training. Researchers tended to involve patients and the public in a range of areas, including input to study design and patient information, in particular., Conclusions: When positioned within a broader organisational strategy for PPI in research, such training has an important role to play in progressing PPI in a major research partnership. Training appeared to provide the confidence needed to carry out PPI which enabled further development of confidence and skills. Involving researchers who have attended the training in the ongoing development of the programme and bringing in patients to the training programme are key next steps., Competing Interests: Competing interests: All authors have completed the Unified Competing Interest form and, with two exceptions, declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years, no other relationships or activities that could appear to have influenced the submitted work. One author discloses that they were a paid employee of the institution running the training discussed at the time this work was undertaken. Another author discloses that they received a fee to deliver the training discussed in the article., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Background: Clinical Trials Units are encouraged to integrate Patient and Public Involvement (PPI) into all aspects of trial design, running and oversight. This research explored the induction and training of PPI Contributors joining trial oversight committees and was used to update the Medical Research Council Clinical Trials Unit at University College London's (MRC CTU at UCL) induction pack for new PPI Contributors., Methods: Published and unpublished materials provided by other CTUs and research organisations on training for PPI Contributors on oversight committees were reviewed, with themes then triangulated to identify the most common topics covered in induction training. A face-to-face workshop with PPI Contributors from the MRC CTU at UCL reviewed a draft updated Induction Pack. Findings from these discussions were incorporated into a revised induction pack which was then re-reviewed by the workshop attendees., Results: No published literature on this subject was found. However, several common themes were identified from unpublished materials. Workshop attendees agreed with most of the themes suggested in the initial draft pack based on the literature search and also provided a number of additional topics for discussion., Conclusions: There is very little consistency in the induction of PPI Contributors on oversight committees. Whilst most local guidance explains the general role of a PPI Contributor, more context and background of the particular trial needs to be provided to allow for adequate induction of new committee members. The Induction Pack created provides a framework upon which trial managers can build a full picture of their study.

Significant mortality of Crassostrea gigas juveniles is observed systematically every year worldwide. Pacific Oyster Mortality Syndrome (POMS) is caused by Ostreid Herpesvirus 1 (OsHV-1) infection leading to immune suppression, followed by bacteraemia caused by a consortium of opportunistic bacteria. Using an in-situ approach and pelagic chambers, our aim in this study was to identify pathogen dynamics in oyster flesh and in the water column during the course of a mortality episode in the Mediterranean Thau lagoon (France). OsHV-1 concentrations in oyster flesh increased before the first clinical symptoms of the disease appeared, reached maximum concentrations during the moribund phase and the mortality peak. The structure of the bacterial community associated with oyster flesh changed in favour of bacterial genera previously associated with oyster mortality including Vibrio, Arcobacter, Psychrobium, and Psychrilyobacter. During the oyster mortality episode, releases of OsHV-1 and opportunistic bacteria were observed, in succession, in the water surrounding the oyster lanterns. These releases may favour the spread of disease within oyster farms and potentially impact other marine species, thereby reducing marine biodiversity in shellfish farming areas., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Objective: to analyse women's experiences of early labour care in caseload midwifery in Australia., Design: this study sits within a multi-site randomised controlled trial of caseload midwifery versus standard care. Participant surveys were conducted at 6-weeks and 6-months after birth. Free-text responses about experiences of care were subject to critical thematic analysis in NVivo 11 software., Setting: two urban Australian hospitals in different states., Participants: women 18 years and over, with a singleton pregnancy, less than 24 weeks' pregnant, not planning a caesarean section or already booked with a care provider; were eligible to participate in the trial., Interventions: participants were randomised to caseload midwifery or standard care for antenatal, labour and birth and postpartum care., Measurements and Findings: The 6-week survey response rate was 58% (n = 1,019). The survey included five open questions about women's experiences of pregnancy, labour and birth, and postnatal care. Nine-hundred and one respondents (88%) provided free text comments which were coded to generate 10 categories. The category of early labour contained data from 84 individual participants (caseload care n = 44; standard care n = 40). Descriptive themes were: (1) needing permission; (2) doing the 'wrong' thing; and (3) being dismissed. Analytic themes were: (1) Seeking: women wanting to be "close to those who know what's going on"; and (2) Shielding: midwives defending resources and normal birth., Key Conclusions: Regardless of model of care, early labour care was primarily described in negative terms. This could be attributed to reporting bias, because women who were neutral about early labour care may not comment. Nevertheless, the findings demonstrate a gap in knowledge about early labour care in caseload midwifery models., Implications for Practice: Maternity services that offer caseload midwifery are ideally placed to evaluate how early labour home visiting impacts women's experiences of early labour., Competing Interests: Declaration of Competing Interest None declared, (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Thau lagoon is a large Mediterranean coastal lagoons and it supports traditional shellfish farming activities. It has been subject to eutrophication leading to major anoxic events associated with massive mortalities of shellfish stocks. Since the 1970s, improvements have been made to wastewater treatment systems, which have gradually led to oligotrophication of the lagoon. The aim of our study was to determine how the decrease in nutrient inputs resulted in major ecological changes in Thau lagoon, by analysing five decades of time-series (1970-2018) of observations on pelagic and benthic autotrophic communities. We were able to identify two periods during the oligotrophication process. Period 1 (1970-1992) was considered a eutrophic period, characterised by the shift from seagrass dominance to dominance of red macroalgae. Period 2 (1993-2018), characterised by improved eutrophication status, was further divided into three: a transition phase (1993-2003) during which the water column continued to recover but the benthic community lagged behind in recovery and in partial resilience; a regime shift (2003-2006), after which the water column became oligotrophic and seagrass began to recover (2007-2018). Considering anoxia crises as indicators of ecosystem resilience and resistance, we used a generalised linear model to analyse meteorological and environmental data with the aim of identifying the triggers of summer anoxia over the study period. Among the meteorological variables studied, air temperature had the strongest positive effect, followed by the period and wind intensity (both negative effects) and by rainfall in July (positive effect). The risk of triggering anoxia was lower in period 2, evidence for the increasing resistance of the ecosystem to climatic stress throughout the oligotrophication process. At the ecosystem scale and in the long term perspective, the ecological gains related to oligotrophication are especially important in the context of climate change, with more frequent and severe heat waves predicted., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Advances in machine learning (ML) and artificial intelligence (AI) present an opportunity to build better tools and solutions to help address some of the world's most pressing challenges, and deliver positive social impact in accordance with the priorities outlined in the United Nations' 17 Sustainable Development Goals (SDGs). The AI for Social Good (AI4SG) movement aims to establish interdisciplinary partnerships centred around AI applications towards SDGs. We provide a set of guidelines for establishing successful long-term collaborations between AI researchers and application-domain experts, relate them to existing AI4SG projects and identify key opportunities for future AI applications targeted towards social good.

Problem: Women increasingly present to hospital in early labour, but admission before active labour contributes to overuse of interventions, poorer clinical and psychological outcomes, and higher healthcare costs., Background: Innovative models of early labour care have so far not improved birth outcomes., Aim: To examine if reconfiguring the early labour service in a large Australian maternity service improved (1) the birth outcomes of women who presented in early labour and (2) alleviated bed blockages by decreasing length of stay in the Pregnancy Assessment and Observation Unit., Methods: Pre-post intervention design, using routinely collected clinical data before and after the implementation of the reconfigured early labour service., Findings: There were 527 women in pre-intervention cohort and 747 in the post-intervention cohort. The two groups were similar in age, body mass index, marital status, education level and gestation at birth. Post intervention, epidural use did not change significantly, but rates of amniotomy (35.7% vs. 49.9%, p = <0.001), meconium-stained liquor (20.1% vs 26.1%, p = 0.04), and neonatal nursery admission (2.7% vs. 5.8% p =  0.01) increased. The proportion of women staying in the Assessment unit more than two hours decreased, but not significantly., Conclusion: Changing the location and model of early labour care did not influence epidural use, nor improve women's birth outcomes. For women in early labour, admission to any location within the hospital may be as problematic as admission to birth suite specifically., (Copyright © 2019 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.)

Background: The PROUD trial, a HIV prevention trial in men who have sex with men and trans women, set out to involve community representatives and trial participants in several ways. PROUD also aimed to evaluate participant involvement, to learn lessons and make recommendations for future clinical trials., Methods: Two structured surveys, one of participant and community representatives involved in the PROUD study, and the other of researchers from the PROUD team, were carried out in 2017. The results from the surveys were reviewed quantitatively and qualitatively, and themes emerging from the data identified and synthesised., Results: Survey invitations were sent to 88 involved participants, 11 community representatives and 10 researchers. The overall response rate was 55% (60/109). Overall, participants were younger than community representatives, and the majority were from Greater London. As expected, participants were predominantly involved in participant involvement meetings and community representatives in management committees.Participants and community representatives cited different motivations for getting involved in PROUD. Overall, participants were positive about their involvement; only two participants rated their experience unfavourably. Community representatives were also broadly positive. Most participants and all community representatives felt their involvement made a difference to the trial, themselves and / or the organisations they represented. However, some participant answers reflected the impact of participation in the trial rather than involvement in PPI activities.Researchers felt that PPI had positive impact across the entire trial cycle. Half felt they would have liked there to have been more PPI activity in PROUD. Researchers noted some challenges and recommendations for the future, including need for adequate funding, more engagement in PPI by all researchers, the need for PPI expertise to facilitate involvement activities and training and mentoring in PPI., Conclusions: Involving clinical trial participants and wider community representatives as active partners in PPI is feasible and valuable in trials. Researchers are encouraged to consider and appropriately resource participant involvement and prospectively evaluate all PPI within their trials., Competing Interests: Competing interestsThe authors declare that they have no competing interests., (© The Author(s) 2020.)

Introduction: Skin is important in Australian Aboriginal culture informing kinship and identity. In many remote Aboriginal communities, scabies and impetigo are very common. Untreated skin infections are painful, itchy and frequently go untreated due to under-recognition and lack of awareness of their potential serious complications. We hypothesise that the skin infection burden in remote Aboriginal communities can be reduced by implementing streamlined training and treatment pathways integrated with environmental health and health promotion activities, tested in the See, Treat, Prevent (SToP skin sores and scabies) trial., Methods and Analysis: SToP will evaluate a skin control programme using a stepped-wedge, cluster randomised trial design with three intervention components (the 'SToP activities'): (1) seeing skin infections (development of training resources implemented within a community dermatology model); (2) treating skin infections (employing the latest evidence for impetigo, and scabies treatment); and (3) preventing skin infections (embedded, culturally informed health promotion and environmental health activities). Four community clusters in the remote Kimberley region of Western Australia will participate. Following baseline data collection, two clusters will be randomly allocated to the SToP activities. At 12 months, the remaining two clusters will transition to the SToP activities. The primary outcome is the diagnosis of impetigo in children (5-9 years) at school-based surveillance. Secondary outcome measures include scabies diagnosis, other child health indicators, resistance to cotrimoxazole in circulating pathogenic bacteria, determining the economic burden of skin disease and evaluating the cost effectiveness of SToP activities., Ethics and Dissemination: This study protocol was approved by the health ethics review committees at the Child and Adolescent Health Service (Approval number RGS0000000584), the Western Australian Aboriginal Health Ethics Committee (Reference number: 819) and the University of Western Australia (Reference RA/4/20/4123). Study findings will be shared with community members, academic and medical communities via publications and presentations, and in reports to funders. Authorship for all publications based on this study will be determined in line with the Uniform Requirements for Manuscripts Submitted to Biomedical Journals published by the International Committee of Medical Journal Editors. Sharing results with organisations and communities who contributed to the study is paramount. The results of the SToP trial will be shared with participants in a suitable format, such as a single summary page provided to participants or presentations to communities, the Kimberly Aboriginal Health Planning Forum Research Subcommittee and other stakeholders as appropriate and as requested. Communication and dissemination will require ongoing consultation with Aboriginal communities to determine appropriate formats., Trial Registration Number: ACTRN12618000520235., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Awareness of the impact of the built environment on health care outcomes and experiences has led to efforts to redesign birthing environments. The Birth Unit Design Spatial Evaluation Tool was developed to inform such improvements, but it has only been validated with caseload midwives and women birthing in caseload models of care., Aim: To assess the content validity of the tool with four new participant groups: Birth unit midwives, Aboriginal or Torres Strait Islander women; women who had anticipated a vaginal birth after a caesarean; and women from refugee or culturally and linguistically diverse backgrounds., Methods: Participants completed a Likert-scale survey to rate the relevance of The Birth Unit Design Spatial Evaluation Tool's 69 items. Item-level content validity and Survey-level validity indices were calculated, with the achievement of validity set at >0.78 and >0.9 respectively., Results: Item-level content validity was achieved on 37 items for birth unit midwives (n=10); 35 items for Aboriginal or Torres Strait Islander women (n=6); 33 items for women who had anticipated a vaginal birth after a caesarean (n=6); and 28 items for women from refugee or culturally and linguistically diverse backgrounds (n=20). Survey-level content validity was not demonstrated in any group., Conclusion: Birth environment design remains significant to women and midwives, but the Birth Unit Design Spatial Evaluation Tool was not validated for these participant groups. Further research is needed, using innovative methodologies to address the subconscious level on which environment may influence experience and to disentangle the influence of confounding factors., (Copyright © 2018 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.)

The European Water Framework Directive and several other legislations worldwide have selected phytoplankton for monitoring the ecological status of surface waters. This assessment is a complicated task in coastal lagoons due to their intrinsic variability, prompting moves to use real-time measurements. Here, we tested the ability of the submersible spectrofluorometer FluoroProbe® to accurately estimate the phytoplankton biomass and to efficiently discriminate spectral groups in Mediterranean coastal lagoons, by using sub-surface water samples (n = 107) collected at Biguglia lagoon (Corsica) in different environmental situations (salinity and trophic state) from March 2012 to December 2014. We compared the estimates of biomass and phytoplankton group composition obtained with the FluoroProbe® (in situ and lab measurements) with the spectrofluorimetrically measured biomass and HPLC-derived quantifications of pigment concentrations. FluoroProbe® provided good estimates of the total phytoplankton biomass (particularly, the lab measurements). The FluoroProbe® data were significantly correlated with the HPLC results, except for the in situ measurements of very weak concentrations of blue-green and red algae. Our findings indicate that factory-calibrated FluoroProbe® is an efficient and easy-to-use real-time phytoplankton monitoring tool in coastal lagoons, especially as an early warning system for the detection of potentially harmful algal blooms. Practical instructions dedicated to non-specialist field operators are provided. A simple and efficient method for discarding in situ measurement outliers is also proposed.

Background: The right to refuse medical treatment can be contentious in maternity care. Professional guidance for midwives and obstetricians emphasises informed consent and respect for patient autonomy, but there is little guidance available to clinicians about the appropriate clinical responses when women decline recommended care., Objectives: We propose a comprehensive, woman-centred, systems-level framework for documentation and communication with the goal of supporting women, clinicians and health services in situations of maternal refusal. We term this the Personalised Alternative Care and Treatment framework., Discussion: The Personalised Alternative Care and Treatment framework addresses Australian policy, practice, education and professional issues to underpin woman-centred care in the context of maternal refusal. It embeds Respectful Maternity Care in system-level maternity care policy; highlights the woman's role as decision maker about her maternity care; documents information exchanged with women; creates a 'living' plan that respects the woman's birth intentions and can be reviewed as circumstances change; enables communication between clinicians; permits flexible initiation pathways; provides for professional education for clinicians, and incorporates a mediation role to act as a failsafe., Conclusion: The Personalised Alternative Care and Treatment framework has the potential to meet the needs of women, clinicians and health services when pregnant women decline recommended maternity care., (Copyright © 2018. Published by Elsevier Ltd.)

Background: Patient and public involvement (PPI) in clinical trials aims to ensure that research is carried out collaboratively with patients and/or members of the public. However, current guidance on involving clinical trial participants in PPI activities is not consistent., Methods: We reviewed the concept of participant involvement, based on our experience. Two workshops were held at the MRCCTU at UCL with the aim of defining participant involvement, considering its rationale; benefits and challenges; and identifying appropriate models for participant involvement in clinical trials. We considered how participant involvement might complement the involvement of other public contributors. Both workshops were attended by two patient representatives and seven staff members with experience of PPI in trials. Two of the staff members had also been involved in studies that had actively involved participants. They shared details of that work to inform discussions., Results: We defined trial participants as individuals taking part in the study in question, including those who had already completed their trial treatment and/or follow-up. Because of their direct experience, involving participants may offer advantages over other public contributors; for example, in studies of new interventions or procedures, and where it is hard to identify or reach patient or community groups that include or speak for the study population. Participant involvement is possible at all stages of a trial; however, because there are no participants to involve during the design stage of a trial, prior to enrolment, participant involvement should complement and not replace involvement of PPI stakeholders. A range of models, including those with managerial, oversight or responsive roles are appropriate for involving participants; however, involvement in data safety and monitoring committees may not be appropriate where there is a potential risk of unblinding. Involvement of participants can improve the trial experience for other participants; optimising study procedures, improving communications; however, there are some specific, notably, managing participant confidentiality and practicalities relating to payments., Conclusions: Participant involvement in clinical trials is feasible and complements other forms of PPI in clinical trials. Involving active participants offers significant advantages, particularly in circumstances where trials are assessing new, or otherwise unavailable, therapies or processes. We recommend that current guidance on PPI should be updated to routinely consider including participants as valid stakeholders in PPI and potentially useful approach to PPI.

Background: pregnant women, like all competent adults, have the right to refuse medical treatment, although concerns about maternal and fetal safety can make doing so problematic. Empirical research about refusal of recommended maternity care has mostly described the attitudes of clinicians, with women's perspectives notably absent., Design: feminist thematic analysis of in-depth, semi-structured interviews with women's (n=9), midwives' (n=12) and obstetricians' (n=9) about their experiences of refusal of recommended maternity care., Findings: three major interrelated themes were identified. "Valuing the woman's journey", encapsulated care experiences that women valued and clinicians espoused, while "The clinician's line in the sand" reflected the bounded nature of support for maternal autonomy. When women's birth intentions were perceived by clinicians to transgress their line in the sand, a range of strategies were reportedly used to convince the woman to accept recommended care. These strategies formed a pattern of "Escalating intrusion"., Key Conclusions and Implications for Practice: declining recommended care situated women at the intersection of two powerful normative discourses: medical dominance and the patriarchal institution of motherhood. Significant pressures on women's autonomy resulted from an apparent gap between clinicians' espoused and reported practices. Implications for policy and practice include a need for specific guidance for clinicians providing care in situations of maternal refusal, the potential value of an independent third-party for advice and advocacy, and the development of models that support reflexive practice amongst clinicians., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

This study investigated the genetic diversity of phytoplankton communities in six shallow lagoons located on the French coast of the northwestern Mediterranean Sea that represented a trophic gradient ranging from oligotrophic to hypereutrophic. The phytoplankton communities were sampled once a month from spring (May) to the beginning of autumn (September/early October) in 2012 and fractionated by size. Metabarcodes were generated from cDNAs by targeting the D1-D2 region of the 28S rRNA gene and pyrosequenced using Roche 454 technology. Examination of the annotated barcodes revealed harmful algal species not previously documented in these lagoons. Three ichthyotoxic species belonging to Pfiesteriaceae were detected: Luciella masanensis was relatively widespread and abundant in many samples, whereas Pfiesteria piscicida and Stoeckeria changwonensis were found as single barcode sequences. Furthermore, a phylogenetic analysis of barcodes annotated as belonging to Pfiesteriaceae suggested the existence of two previously undescribed clades. The other toxic or potentially harmful dinoflagellates detected through rare barcodes were Dinophysis acuminata, Vulcanodinium rugosum, Alexandrium andersonii and A. ostenfeldii. The two most abundant dinoflagellate taxa were Gymnodinium litoralis and Akashiwo sanguinea with respect to sequence numbers. Four diatom species from the genus Pseudo-nitzschia that potentially produce domoic acid were identified (P. galaxiae, P. delicatissima, P. brasiliana and P. calliantha). These observations are discussed in terms of the literature and monitoring records related to the identified taxa in this Mediterranean area., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Background: With technology advancements making vast amounts of health information available whenever and wherever it is required, there is a growing need to understand how this information is being accessed and used., Objective: Our aim was to explore patients/public and health professionals' experiences, practices and preferences for accessing health information., Methods: Focus groups were conducted with 35 healthcare professionals (31 nurses and 4 allied health professionals) and 14 patients/members of the public. Semi-structured interviews were conducted with 5 consultants, who were unable to attend the focus groups. Data collection took place between March and May 2013 and all data were analysed thematically., Results: Health professionals and patients/members of the public reported primarily accessing health information to inform their decision making for providing and seeking treatment respectively. For all participants the internet was the primary mechanism for accessing health information, with health professionals' access affected by open access charges; time constraints and access to computers. Variation in how patients/members of the public and health professionals appraise the quality of information also emerged, with a range of techniques for assessing quality reported., Conclusions: There was a clear preference for accessing health information online within our sample. Given that this information is central to both patient and health professionals' decision making, it is essential that these individuals are basing their decisions on high quality information. Findings from this study have implications for educationalists, health professionals, policymakers and the public., (Copyright © 2017 Elsevier B.V. All rights reserved.)

The aim of the present study was to describe incidences of restrictive interventions and the association of methamphetamine use at an acute adult inpatient mental health unit in metropolitan Melbourne, Victoria, Australia. A total of 232 consecutive consumer admissions to the inpatient unit across a 3-month period were described for illicit substance use and the use of restrictive interventions (seclusion, mechanical restraint, and physical restraint) prior to and during admission. Of all admissions, 25 (10.8%) involved consumers subjected to a restrictive intervention. Methamphetamine use was either self-reported or detected by saliva test for 71 (30.6%) consumers. Following multivariate analyses, methamphetamine use (odds ratio (OR): 7.83, 95% confidence interval (CI): 2.33-26.31) and restrictive intervention in the emergency department prior to admission (OR: 8.85, 95% CI: 2.83-27.70) were significant independent predictors of the use of restrictive interventions after inpatient admission. Anecdotal observations provided by clinical mental health staff that consumers intoxicated with methamphetamine appear to require restrictive intervention more frequently than other consumers was confirmed with the results of the current study. As the state of Victoria in Australia is on a pathway to the elimination of the use of restrictive interventions in mental health services, clinicians need to develop management strategies that provide specialist mental health care using the least-restrictive interventions. Although 26.8% of methamphetamine users were secluded after admission, restrictive interventions should not be the default management strategy for consumers who present with self-report or positive screen for methamphetamine use., (© 2016 Australian College of Mental Health Nurses Inc.)

Problem/background: Ethical and professional guidance for midwives and obstetricians emphasises informed consent and respect for patient autonomy; the right to refuse care is well established. However, the existing literature is largely silent on the appropriate clinical responses when pregnant women refuse recommended care, and accounts of disrespectful interactions and conflict are numerous. Policies and processes to support women and maternity care providers are rare and unstudied., Aim: To document the perspectives of women, midwives and obstetricians following the introduction of a structured process (Maternity Care Plan; MCP) to document refusal of recommended maternity care in a large tertiary maternity unit., Methods: A qualitative, interpretive study involved thematic analysis of in-depth semi-structured interviews with women (n=9), midwives (n=12) and obstetricians (n=9)., Findings: Four major themes were identified including: 'Reassuring and supporting clinicians'; 'Keeping the door open'; 'Varied awareness, criteria and use of the MCP process' and 'No guarantees'., Conclusion: Clinicians felt protected and reassured by the structured documentation and communication process and valued keeping women engaged in hospital care. This, in turn, protected women's access to maternity care. However, the process could not guarantee favourable responses from other clinicians subsequently involved in the woman's care. Ongoing discussions of risk, perceived by women and some midwives to be pressure to consent to recommended care, were still evident. These limitations may have been attributable to the absence of agreed criteria for initiating the MCP process and fragmented care. Varying awareness and use of the process also diminished women's access to it., (Copyright © 2016 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.)

Background: Primary Maternity Units (PMUs) offer less expensive and potentially more sustainable maternity care, with comparable or better perinatal outcomes for normal pregnancy and birth than higherlevel units. However, little is known about how these maternity services operate in rural and remote Australia, in regards to location, models of care, service structure, support mechanisms or sustainability. This study aimed to confirm and describe how they operate., Design: a descriptive, cross-sectional study was undertaken, utilising a 35-item survey to explore current provision of maternity care in rural and remote PMUs across Australia. Data were subjected to simple descriptive statistics and thematic analysis for free text answers., Setting and Participants: Only 17 PMUs were identified in rural and remote areas of Australia. All 17 completed the survey., Results: the PMUs were, on average, 56km or 49minutes from their referral service and provided care to an average of 59 birthing women per year. Periodic closures or downgrading of services was common. Low-risk eligibility criteria were universally used, but with some variability. Medically-led care was the most widely available model of care. In most PMUs midwives worked shift work involving both nursing and midwifery duties, with minimal uptake of recent midwifery workforce innovations. Perceived enablers of, and threats to, sustainability were reported., Key Conclusions and Implications for Practice: a small number of PMUs operate in rural Australia, and none in remote areas. Continuing overreliance on local medical support, and under-utilisation of the midwifery workforce constrain the restoration of maternity services to rural and remote Australia., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Background: Patient and public involvement (PPI) in studies carried out by the UK Medical Research Council Clinical Trials Unit (MRC CTU) at University College London varies by research type and setting. We developed a series of case studies of PPI to document and share good practice., Methods: We used purposive sampling to identify studies representing the scope of research at the MRC CTU and different approaches to PPI. We carried out semi-structured interviews with staff and patient representatives. Interview notes were analysed descriptively to categorise the main aims and motivations for involvement; activities undertaken; their impact on the studies and lessons learned., Results: We conducted 19 interviews about ten case studies, comprising one systematic review, one observational study and 8 randomised controlled trials in HIV and cancer. Studies were either open or completed, with start dates between 2003 and 2011. Interviews took place between March and November 2014 and were updated in summer 2015 where there had been significant developments in the study (i.e. if the study had presented results subsequent to the interview taking place). A wide range of PPI models, including representation on trial committees or management groups, community engagement, one-off task-focused activities, patient research partners and participant involvement had been used. Overall, interviewees felt that PPI had a positive impact, leading to improvements, for example in the research question; study design; communication with potential participants; study recruitment; confidence to carry out or complete a study; interpretation and communication of results; and influence on future research., Conclusions: A range of models of PPI can benefit clinical studies. Researchers should consider different approaches to PPI, based on the desired impact and the people they want to involve. Use of multiple models may increase the potential impacts of PPI in clinical research.

Plain English Summary: In Australia, since 2009, the Consumer and Community Involvement Program (formerly the Consumer and Community Participation Program) has developed and run workshops to help people working in health and medical research involve more consumers (patients) and community members (the public) in their research. In 2012, workshop attendees were invited to do an online survey to find out the effect, if any, that attending a workshop had on their awareness of and attitudes to consumer and community involvement. They were also asked about changes in their behaviour when it came to the involvement of consumers and the community in their work. The study found that, for people who answered the survey, more than double the number found consumer and community involvement very relevant after attending a workshop, compared with the number who thought that before attending one. Also, amongst those who answered the survey, 94 % thought that the workshop increased their understanding about involvement., Abstract: Background There is limited evidence of the benefits of providing training workshops for researchers on how to involve consumers (patients) and the community (public) in health and medical research. Australian training workshops were evaluated to contribute to the evidence base. The key objective was to evaluate the impact of the workshops in increasing awareness of consumer and community involvement; changing attitudes to future implementation of involvement activities and influencing behaviour in the methods of involvement used. A secondary objective was to use a formal evaluation survey to build on the anecdotal feedback received from researchers about changes in awareness, attitudes and behaviours. Methods The study used a cross-sectional, online survey of researchers, students, clinicians, administrators and members of non-government organisations who attended Consumer and Community Involvement Program training workshops between 2009 and 2012 to ascertain changes to awareness, attitudes and behaviours related to consumer and community involvement in health and medical research. Results Changes in awareness and attitudes were demonstrated by more than double the number of respondents finding involvement very relevant after attending a workshop compared with those who did so before attending; 94 % of respondents agreed that the workshops increased their understanding of how involvement can add value to research. Conclusions The training workshops raised awareness and increased relevance of consumer and community involvement among Australian researchers who attended a workshop and responded to the survey. The results of the survey are also suggestive that the training led to behaviour changes through increased consumer and community involvement.

Background: All competent adults have the right to refuse medical treatment. When pregnant women do so, ethical and medico-legal concerns arise and women may face difficulties accessing care. Policies guiding the provision of maternity care in these circumstances are rare and unstudied. One tertiary hospital in Australia has a process for clinicians to plan non-standard maternity care via a Maternity Care Plan (MCP)., Aim: To review processes and outcomes associated with MCPs from the first three and a half years of the policy's implementation., Methods: Retrospective cohort study comprising chart audit, review of demographic data and clinical outcomes, and content analysis of MCPs., Findings: MCPs (n=52) were most commonly created when women declined recommended caesareans, preferring vaginal birth after two caesareans (VBAC2, n=23; 44.2%) or vaginal breech birth (n=7, 13.5%) or when women declined continuous intrapartum monitoring for vaginal birth after one caesarean (n=8, 15.4%). Intrapartum care deviated from MCPs in 50% of cases, due to new or worsening clinical indications or changed maternal preferences. Clinical outcomes were reassuring. Most VBAC2 or VBAC>2 (69%) and vaginal breech births (96.3%) were attempted without MCPs, but women with MCPs appeared more likely to birth vaginally (VBAC2 success rate 66.7% with MCP, 17.5% without; vaginal breech birth success rate, 50% with MCP, 32.5% without)., Conclusions: MCPs enabled clinicians to provide care outside of hospital policies but were utilised for a narrow range of situations, with significant variation in their application. Further research is needed to understand the experiences of women and clinicians., (Copyright © 2015 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.)

Duchenne muscular dystrophy (DMD) is associated with language disabilities and deficits in learning and memory, leading to intellectual disability in a patient subpopulation. Recent studies suggest the presence of broader deficits affecting information processing, short-term memory and executive functions. While the absence of the full-length dystrophin (Dp427) is a common feature in all patients, variable mutation profiles may additionally alter distinct dystrophin-gene products encoded by separate promoters. However, the nature of the cognitive dysfunctions specifically associated with the loss of distinct brain dystrophins is unclear. Here we show that the loss of the full-length brain dystrophin in mdx mice does not modify the perception and sensorimotor gating of auditory inputs, as assessed using auditory brainstem recordings and prepulse inhibition of startle reflex. In contrast, both acquisition and long-term retention of cued and trace fear memories were impaired in mdx mice, suggesting alteration in a functional circuit including the amygdala. Spatial learning in the water maze revealed reduced path efficiency, suggesting qualitative alteration in mdx mice learning strategy. However, spatial working memory performance and cognitive flexibility challenged in various behavioral paradigms in water and radial-arm mazes were unimpaired. The full-length brain dystrophin therefore appears to play a role during acquisition of associative learning as well as in general processes involved in memory consolidation, but no overt involvement in working memory and/or executive functions could be demonstrated in spatial learning tasks., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Patient and public involvement (PPI) is advocated in clinical trials yet evidence on how to optimise its impact is limited. We explored researchers' and PPI contributors' accounts of the impact of PPI within trials and factors likely to influence its impact., Methods: Semi-structured qualitative interviews with researchers and PPI contributors accessed through a cohort of randomised clinical trials. Analysis of transcripts of audio-recorded interviews was informed by the principles of the constant comparative method, elements of content analysis and informant triangulation., Results: We interviewed 21 chief investigators, 10 trial managers and 17 PPI contributors from 28 trials. The accounts of informants within the same trials were largely in agreement. Over half the informants indicted PPI had made a difference within a trial, through contributions that influenced either an aspect of a trial, or how researchers thought about a trial. According to informants, the opportunity for PPI to make a difference was influenced by two main factors: whether chief investigators had goals and plans for PPI and the quality of the relationship between the research team and the PPI contributors. Early involvement of PPI contributors and including them in responsive (e.g. advisory groups) and managerial (e.g. trial management groups) roles were more likely to achieve impact compared to late involvement and oversight roles (e.g. trial steering committees)., Conclusion: Those seeking to enhance PPI in trials should develop goals for PPI at an early stage that fits the needs of the trial, plan PPI implementation in accordance with these goals, invest in developing good relationships between PPI contributors and researchers, and favour responsive and managerial roles for contributors in preference to oversight-only roles. These features could be used by research funders in judging PPI in trial grant applications and to inform policies to optimise PPI within trials.

Background: Training in patient and public involvement (PPI) is recommended, yet little is known about what training is needed. We explored researchers' and PPI contributors' accounts of PPI activity and training to inform the design of PPI training for both parties., Methods: We used semi-structured qualitative interviews with researchers (chief investigators and trial managers) and PPI contributors, accessed through a cohort of clinical trials, which had been funded between 2006 and 2010. An analysis of transcripts of audio-recorded interviews drew on the constant comparative method., Results: We interviewed 31 researchers and 17 PPI contributors from 28 trials. Most researchers could see some value in PPI training for researchers, although just under half had received such training themselves, and some had concerns about the purpose and evidence base for PPI training. PPI contributors were evenly split in their perceptions of whether researchers needed training in PPI. Few PPI contributors had themselves received training for their roles. Many informants across all groups felt that training PPI contributors was unnecessary because they already possessed the skills needed. Informants were also concerned that training would professionalise PPI contributors, limiting their ability to provide an authentic patient perspective. However, informants welcomed informal induction 'conversations' to help contributors understand their roles and support them in voicing their opinions. Informants believed that PPI contributors should be confident, motivated, intelligent, focussed on helping others and have relevant experience. Researchers looked for these qualities when selecting contributors, and spoke of how finding 'the right' contributor was more important than accessing 'the right' training., Conclusions: While informants were broadly receptive to PPI training for researchers, they expressed considerable reluctance to training PPI contributors. Providers of training will need to address these reservations. Our findings point to the importance of reconsidering how training is conceptualised, designed and promoted and of providing flexible, learning opportunities in ways that flow from researchers' and contributors' needs and preferences. We also identify some areas of training content and the need for further consideration to be given to the selection of PPI contributors and models for implementing PPI to ensure clinical trials benefit from a diversity of patient perspectives.

Early warning systems aim to detect clinical deterioration of patients at an early stage. Between the Flags was introduced in New South Wales Health for this purpose. When patients are transferred from the emergency department to the ward, there are circumstances when the calling criteria need to be altered to take into account the clinical context. It is recognised that confusion exists among junior medical staff about the process of making alterations to the Between the Flags calling criteria. A quality improvement project was implemented by undertaking a baseline survey of junior medical staff, providing education and training (to junior medical staff on the existing guidelines for making alteration to the calling criteria), and conducting a post-implementation survey. A baseline survey demonstrated that 74% of junior medical staff had received no education on making alterations and only 5% knew how long their alterations would last once the patient was transferred to the ward. This has potentially serious consequences for patient safety following transfer. After implementation of training, we found that 63% of junior medical staff were aware of the guidelines on making alterations and 50% knew how long their alterations would last once the patient was transferred to the ward. We conclude that educating junior medical staff improved knowledge on the guidelines for making alterations to calling criteria.

The aim of this study was to describe the reorientation of a remote primary health-care service, in the Kimberley region of Australia, its impact on access to services and the factors instrumental in bringing about change. A unique community-initiated health service partnership was developed between a community-controlled Aboriginal health organisation, a government hospital and a population health unit, in order to overcome the challenges of delivering primary health care to a dispersed, highly disadvantaged Aboriginal population in a very remote area. The shared goals and clear delineation of responsibilities achieved through the partnership reoriented an essentially acute hospital-based service to a prevention-focussed comprehensive primary health-care service, with a focus on systematic screening for chronic disease, interdisciplinary follow up, health promotion, community advocacy and primary prevention. This formal partnership enabled the primary health-care service to meet the major challenges of providing a sustainable, prevention-focussed service in a very remote and socially disadvantaged area.

Unlabelled: : Patient and public involvement (PPI) in research is increasingly required, although evidence to inform its implementation is limited., Objective: Inform the evidence base by describing how plans for PPI were implemented within clinical trials and identifying the challenges and lessons learnt by research teams., Methods: We compared PPI plans extracted from clinical trial grant applications (funded by the National Institute for Health Research Health Technology Assessment Programme between 2006 and 2010) with researchers' and PPI contributors' interview accounts of PPI implementation. Analysis of PPI plans and transcribed qualitative interviews drew on the Framework technique., Results: Of 28 trials, 25 documented plans for PPI in funding applications and half described implementing PPI before applying for funding. Plans varied from minimal to extensive, although almost all anticipated multiple modes of PPI. Interview accounts indicated that PPI plans had been fully implemented in 20/25 trials and even expanded in some. Nevertheless, some researchers described PPI within their trials as tokenistic. Researchers and contributors noted that late or minimal PPI engagement diminished its value. Both groups perceived uncertainty about roles in relation to PPI, and noted contributors' lack of confidence and difficulties attending meetings. PPI contributors experienced problems in interacting with researchers and understanding technical language. Researchers reported difficulties finding 'the right' PPI contributors, and advised caution when involving investigators' current patients., Conclusions: Engaging PPI contributors early and ensuring ongoing clarity about their activities, roles and goals, is crucial to PPI's success. Funders, reviewers and regulators should recognise the value of preapplication PPI and allocate further resources to it. They should also consider whether PPI plans in grant applications match a trial's distinct needs. Monitoring and reporting PPI before, during and after trials will help the research community to optimise PPI, although the need for ongoing flexibility in implementing PPI should also be recognised., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Background: Randomised controlled trials (RCTs) are considered particularly likely to benefit from patient and public involvement (PPI). Decisions made by professional researchers at the outset may go on to have a significant impact on the potential for PPI contributions., Objective: To increase knowledge of PPI within the early development of RCTs by systematically describing the reported level, nature and acceptability of proposed PPI to the funders., Methods: Documentation from the outline application process for all RCTs that received funding from the Health Technology Assessment (HTA) Programme 2006-2010 was requested. For each application, data were extracted on trial characteristics, references to PPI in the development of the outline application and funding Board feedback, and plans for PPI in the full application and after the trial was funded., Results: 110 applications were eligible with outline applications available for 90 (82%). The cohort covered a wide range of interventions and conditions. 54% (49/90) provided some information about PPI. 26 (28.9%) indicated PPI within the development of the outline application itself; 32 (35.6%) planned involvement in the full application and 43 (48%) once the trial was funded. Recruitment at diagnosis and surgical interventions were less likely to describe PPI. Blinded trials and trials in which participants may receive placebo only, more frequently described PPI activity. The HTA commissioning Board feedback rarely referred to PPI., Conclusions: Incorporation of PPI within the development of the outline application or specification of plans for future involvement was low. Funder requests for applicants to provide information on PPI and justification for its absence should be welcomed but further research is needed to identify the impact of this on its contributions to research. Comments on PPI by reviewers should be directional rather than state that an increase is required. Challenges facing applicants in initiating PPI prior to funding need to be addressed., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Background: Efforts to increase postnatal support available to women and families are hampered by inadequate referral mechanisms. However, the discharge process in maternity services has received little research attention., Aim: To review current discharge practices in Queensland, in order to identify mechanisms to minimise fragmentation in the care of women and families as they transition from hospital-based postnatal care to community-based health and other services., Methods: A survey of discharge practices in Queensland hospitals that offer birthing services (N=55) and content analysis of discharge summary forms used by those hospitals., Findings: Fifty-two Queensland birthing hospitals participated in the study. Discharge summaries were most commonly sent to General Practitioners (83%), less commonly to Child and Family Health Nurses (CFHNs; 52%) and rarely to other care providers. Discharge summaries were usually disseminated within one week of discharge (87%), but did not capture any information about care provided by domiciliary services. Almost one-fifth (19%) of hospitals did not seek women's consent for the disclosure of their discharge summary and only 10% of hospitals had processes for women to check accuracy. Significant gaps in the content of discharge summaries were identified, particularly in psychosocial and cultural information, and post-discharge advice. The format of discharge summaries diminished their readability., Conclusion: Discharge summaries (format and content) should be consistent, comprehensive and specific to maternity services. Discharge summaries should be generated and disseminated electronically at the time of discharge from the maternity service. Women should review their discharge summaries and direct and consent to its dissemination., (Copyright © 2013 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.)

Objective: Effective interventions to improve population and individual health require environmental change as well as strategies that target individual behaviours and clinical factors. This is the basis of implementing an ecological approach to health programs and health promotion. For Aboriginal People and Torres Strait Islanders, colonisation has made the physical and social environment particularly detrimental for health., Methods and Results: We conducted a literature review to identify Aboriginal health interventions that targeted environmental determinants of health, identifying 21 different health programs. Program activities that targeted environmental determinants of health included: Caring for Country; changes to food supply and/or policy; infrastructure for physical activity; housing construction and maintenance; anti-smoking policies; increased workforce capacity; continuous quality improvement of clinical systems; petrol substitution; and income management. Targets were categorised according to Miller's Living Systems Theory. Researchers using an Indigenous community based perspective more often identified interpersonal and community-level targets than were identified using a Western academic perspective., Conclusions: Although there are relatively few papers describing interventions that target environmental determinants of health, many of these addressed such determinants at multiple levels, consistent to some degree with an ecological approach. Interpretation of program targets sometimes differed between academic and community-based perspectives, and was limited by the type of data reported in the journal articles, highlighting the need for local Indigenous knowledge for accurate program evaluation., Implications: While an ecological approach to Indigenous health is increasingly evident in the health research literature, the design and evaluation of such programs requires a wide breadth of expertise, including local Indigenous knowledge.

Background: Like all health care consumers, pregnant women have the right to make autonomous decisions about their medical care. However, this right has created confusion for a number of maternity care stakeholders, particularly in situations when a woman's decision may lead to increased risk of harm to the fetus. Little is known about care providers' perceptions of this situation, or of their legal accountability for outcomes experienced in pregnancy and birth. This paper examined maternity care providers' attitudes and beliefs towards women's right to make autonomous decisions during pregnancy and birth, and the legal responsibility of professionals for maternal and fetal outcomes., Methods: Attitudes and beliefs around women's autonomy and health professionals' legal accountability were measured in a sample of 336 midwives and doctors from both public and private health sectors in Queensland, Australia, using a questionnaire available online and in paper format. Student's t-test was used to compare midwives' and doctors' responses., Results: Both maternity care professionals demonstrated a poor understanding of their own legal accountability, and the rights of the woman and her fetus. Midwives and doctors believed the final decision should rest with the woman; however, each also believed that the needs of the woman may be overridden for the safety of the fetus. Doctors believed themselves to be ultimately legally accountable for outcomes experienced in pregnancy and birth, despite the legal position that all health care professionals are responsible only for adverse outcomes caused by their own negligent actions. Interprofessional differences were evident, with midwives and doctors significantly differing in their responses on five of the six items., Conclusions: Maternity care professionals inconsistently supported women's right to autonomous decision making during pregnancy and birth. This finding is further complicated by care providers' poor understanding of legal accountability for outcomes experienced in pregnancy and birth. The findings of this study support the need for guidelines on decision making in pregnancy and birth for maternity care professionals, and for recognition of interprofessional differences in beliefs around the rights of the woman, her fetus and health professionals in order to facilitate collaborative practice.

Background: In April 2005, researchers based at the Medical Research Council Clinical Trials Unit, set out to involve women affected by cervical cancer in a systematic review and meta-analysis of individual patient data to evaluate treatments for this disease. Each of the women had previously been treated for cervical cancer. Following completion of the meta-analysis, we aimed to evaluate the process of involvement from the researcher and research partner perspective., Methods: An advisory group was first established to give advice on recruiting, supporting and involving women and led to efforts to recruit women to take part in the systematic review using different approaches. Evaluation of the process and outcomes of the partnership between the systematic reviewers and the patients, in respect to what the partnership achieved; what worked well and what were the difficulties; what was learned and the resource requirements, took place during the conduct of the meta-analysis and again after completion of the project., Results: Six women, each of whom had received treatments for cervical cancer, were recruited as Patient Research Partners and five of these women subsequently took part in a variety of activities around the systematic review. They attended progress meetings and all but one attended a meeting at which the first results of the review were presented to all collaborators and gave feedback. Three of the women also became involved in a further related research project which led to an editorial publication from the patient perspective and also participated, along with two lead researchers, in the evaluation of the process and outcomes. While they were generally positive about the experience, one Patient Research Partner questioned the extent of the impact patients could make to the systematic review process., Conclusions: In general, researchers and patient research partners felt that they had learned a lot from the process and considered it to have been a positive experience. The researchers felt that because of resource implications, patient involvement in future systematic reviews would probably have to be prioritized to those in which the greatest impacts could be achieved.

Background: We aimed to establish levels of consumer involvement in randomised controlled trials (RCTs), meta-analyses and other studies carried out by the UK Medical Research Council (MRC) Clinical Trials Unit across the range of research programs, predominantly in cancer and HIV., Methods: Staff responsible for studies that were included in a Unit Progress Report (MRC CTU, April 2009) were asked to complete a semi-structured questionnaire survey regarding consumer involvement. This was defined as active involvement of consumers as partners in the research process and not as subjects of that research. The electronic questionnaires combined open and closed questions, intended to capture quantitative and qualitative information on whether studies had involved consumers; types of activities undertaken; recruitment and support; advantages and disadvantages of involvement and its perceived impact on aspects of the research., Results: Between October 2009 and April 2010, 138 completed questionnaires (86%) were returned. Studies had been conducted over a 20 year period from 1989, and around half were in cancer; 30% in HIV and 20% were in other disease areas including arthritis, tuberculosis and blood transfusion medicine. Forty-three studies (31%) had some consumer involvement, most commonly as members of trial management groups (TMG) [88%]. A number of positive impacts on both the research and the researcher were identified. Researchers generally felt involvement was worthwhile and some felt that consumer involvement had improved the credibility of the research. Benefits in design and quality, trial recruitment, dissemination and decision making were also perceived. Researchers felt they learned from consumer involvement, albeit that there were some barriers., Conclusions: Whilst most researchers identified benefits of involving consumers, most of studies included in the survey had no involvement. Information from this survey will inform the development of a unit policy on consumer involvement, to guide future research conducted within the MRC Clinical Trials Unit and beyond.

Background: Service user involvement is embedded in the United Kingdom's National Health Service, but knowledge about the impact of involvement on service users, such as the benefits and challenges of involvement, is scant. Our research addresses this gap., Objective: To explore the personal impact of involvement on the lives of service users affected by cancer., Design: We conducted eight focus groups with user groups supplemented by nine face-to-face interviews with involved individuals active at a local, regional and national level. Thematic analysis was conducted both independently and collectively., Setting and Participants: Sixty-four participants, engaged in involvement activities in cancer services, palliative care and research, were recruited across Great Britain., Results: We identified three main themes: (i) 'Expectations and motivations for involvement'- the desire to improve services and the need for user groups to have a clear purpose, (ii) 'Positive aspects of involvement'- support provided by user groups and assistance to live well with cancer and (iii) 'Challenging aspects of involvement'- insensitivities and undervaluing of involvement by staff., Conclusions: This study identified that involvement has the capacity to produce varied and significant personal impacts for involved people. Involvement can be planned and implemented in ways that increase these impacts and that mediates challenges for those involved. Key aspects to increase positive impact for service users include the value service providers attach to involvement activities, the centrality with which involvement is embedded in providers' activities, and the capacity of involvement to influence policy, planning, service delivery, research and/or practice., (© 2010 Blackwell Publishing Ltd.)

The aim of this study was to compare levels of agreement in the assessment of suicide risk by detention center staff procedures compared with those completed by a mental health clinician. Over a 6-month period, 64 young people (mean age 15.0 years; SD+/-1.3) assessed as being acutely suicidal were referred for a clinical mental health assessment and completion of the Adolescent Suicide Questionnaire (ASQ). Cohen's kappa statistic was used to determine inter-judgmental agreement between the detention center, a clinical assessment and ASQ scores. Weak levels of agreement existed in the assessment of suicide. We recommend further work in this area and broad discussion toward development of national guidelines to standardize the assessment of suicide risk for young people in youth detention.