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Clinical trial data sharing: heres the challenge

Por: Kochhar · S. · Knoppers · B. · Gamble · C. · Chant · A. · Koplan · J. · Humphreys · G. S.

Anonymised patient-level data from clinical research are increasingly recognised as a fundamental and valuable resource. It has value beyond the original research project and can help drive scientific research and innovations and improve patient care. To support responsible data sharing, we need to develop systems that work for all stakeholders. The members of the Independent Review Panel (IRP) for the data sharing platform Clinical Study Data Request (CSDR) describe here some summary metrics from the platform and challenge the research community on why the promised demand for data has not been observed.

Summary of data

From 2014 to the end of January 2019, there were a total of 473 research proposals (RPs) submitted to CSDR. Of these, 364 met initial administrative and data availability checks, and the IRP approved 291. Of the 90 research teams that had completed their analyses by January 2018, 41 reported at least one resulting publication to CSDR. Less than half of the studies ever listed on CSDR have been requested.


While acknowledging there are areas for improvement in speed of access and promotion of the platform, the total number of applications for access and the resulting publications have been low and challenge the sustainability of this model. What are the barriers for data contributors and secondary analysis researchers? If this model does not work for all, what needs to be changed? One thing is clear: that data access can realise new and unforeseen contributions to knowledge and improve patient health, but this will not be achieved unless we build sustainable models together that work for all.

Reconnecting mothers and children after violence (RECOVER): a feasibility study protocol of child-parent psychotherapy in Australia

Por: Hooker · L. · Toone · E. · Raykar · V. · Humphreys · C. · Morris · A. · Westrupp · E. · Taft · A.

Intimate partner violence detrimentally affects the social and emotional well-being of children and mothers. These two populations are impacted both individually and within the context of their relationship with one another. Child mental health, maternal mental health and the mother–child relationship may be impaired as a consequence. Early intervention to prevent or arrest impaired mother–child attachment and child development is needed. Dyadic or relational mental health interventions that include mothers with their children, such as child–parent psychotherapy, are effective in improving the mental health of both children and mothers and also strengthening their relationship. While child–parent psychotherapy has been trialled overseas in several populations, Australian research on relational interventions for children and women recovering from violence is limited. This study aims to assess the acceptability and feasibility of implementing child–parent psychotherapy in Australian families.

Methods and analysis

Using a mixed methods, prepost design this feasibility study will examine the acceptability of the intervention to women with preschool aged children (3–5 years, n=15 dyads) and providers, and identify process issues including recruitment, retention and barriers to implementation and sustainability. In addition, intervention efficacy will be assessed using maternal and child health outcomes and functioning, and mother–child attachment measures. Young children’s mental health needs are underserviced in Australia. More research is needed to fully understand parenting in the context of intimate partner violence and what works to help women and children recover. If the intervention is found to be feasible, findings will inform future trials and expansion of child–parent psychotherapy in Australia.

Ethics and dissemination

Ethics approval obtained from clinical sites and the La Trobe University Human Research Ethics Committee (ID: HEC17-108). Results will be disseminated through conference proceedings and academic publications.

Working with women who use force: a feasibility study protocol of the Positive (+)SHIFT group work programme in Australia

Por: Kertesz · M. · Humphreys · C. · Larance · L. Y. · Vicary · D. · Spiteri-Staines · A. · Ovenden · G.

This study assesses the feasibility of the Positive Shift (+SHIFT) programme in the context of legal responses and social welfare provision in the state of Victoria, Australia.

The +SHIFT programme, adapted from the Vista curriculum, is a group work and case management programme for women who use force. Building on traditional survivor support group strengths, the programme facilitates participants’ engagement with viable alternatives to force while promoting healing. The study also aims to increase understanding about the characteristics and needs of women who use force in Australia.

Methods and analysis

This feasibility study will assess the +SHIFT programme’s appropriateness in addressing women’s use of force in the Victorian context. Process evaluation will be undertaken to identify recruitment, retention, women’s participation, barriers to implementation, the appropriateness of proposed outcome measures and other issues. The feasibility of an outcome evaluation which would employ a longitudinal mixed methods design with measures administered at preprogramme, programme completion and 3 months postprogramme time points, along with semistructured interviews with participants, programme staff and referring professionals, will also be assessed.

Ethics and dissemination

Research ethics approval was obtained from the University of Melbourne Human Research Ethics Committee. Results of the study will be communicated to the programme providers as part of the action research process evaluation methodology. On completion, final results will be reported to programme providers and funding bodies, and published in academic journals and presented at national and international conferences.

Costs and effects of higher turnover of nurses and Aboriginal health practitioners and higher use of short-term nurses in remote Australian primary care services: an observational cohort study

Por: Zhao · Y. · Russell · D. J. · Guthridge · S. · Ramjan · M. · Jones · M. P. · Humphreys · J. S. · Wakerman · J.

To compare the costs and effects of higher turnover of resident nurses and Aboriginal health practitioners and higher use of agency-employed nurses in remote primary care (PC) services and quantify associations between staffing patterns and health outcomes in remote PC clinics in the Northern Territory (NT) of Australia.


Observational cohort study, using hospital admission, financial and payroll data for the period 2013–2015.


53 NT Government run PC clinics in remote communities.

Outcome measures

Incremental cost-effectiveness ratios were calculated for higher compared with lower turnover and higher compared with lower use of agency-employed nurses. Costs comprised PC, travel and hospitalisation costs. Effect measures were total hospitalisations and years of life lost per 1000 person-months. Multiple regression was performed to investigate associations between overall health costs and turnover rates and use of agency-employed nurses, after adjusting for key confounders.


Higher turnover was associated with significantly higher hospitalisation rates (p


High turnover of health staff is costly and associated with poorer health outcomes for Aboriginal peoples living in remote communities. High reliance on agency nurses is also very likely to be cost-ineffective. Investment in a coordinated range of workforce strategies that support recruitment and retention of resident nurses and Aboriginal health practitioners in remote clinics is needed to stabilise the workforce, minimise the risks of high staff turnover and over-reliance on agency nurses and thereby significantly reduce expenditure and improve health outcomes.

Transnasal Humidified Rapid Insufflation Ventilatory Exchange in children requiring emergent intubation (Kids THRIVE): a protocol for a randomised controlled trial

Por: George · S. · Humphreys · S. · Williams · T. · Gelbart · B. · Chavan · A. · Rasmussen · K. · Ganeshalingham · A. · Erickson · S. · Ganu · S. S. · Singhal · N. · Foster · K. · Gannon · B. · Gibbons · K. · Schlapbach · L. J. · Festa · M. · Dalziel · S. · Schibler · A. · on behalf of the Pa

Emergency intubation of children with abnormal respiratory or cardiac physiology is a high-risk procedure and associated with a high incidence of adverse events including hypoxemia. Successful emergency intubation is dependent on inter-related patient and operator factors. Preoxygenation has been used to maximise oxygen reserves in the patient and to prolong the safe apnoeic time during the intubation phase. Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) prolongs the safe apnoeic window for a safe intubation during elective intubation. We designed a clinical trial to test the hypothesis that THRIVE reduces the frequency of adverse and hypoxemic events during emergency intubation in children and to test the hypothesis that this treatment is cost-effective compared with standard care.

Methods and analysis

The Kids THRIVE trial is a multicentre randomised controlled trial performed in participating emergency departments and paediatric intensive care units. 960 infants and children aged 0–16 years requiring emergency intubation for all reasons will be enrolled and allocated to THRIVE or control in a 1:1 allocation with stratification by site, age (7 years) and operator (junior and senior). Children allocated to THRIVE will receive weight appropriate transnasal flow rates with 100% oxygen, whereas children in the control arm will not receive any transnasal oxygen insufflation. The primary outcomes are defined as follows: (1) hypoxemic event during the intubation phase defined as SpO2

Ethics and dissemination

Ethics approval for the protocol and consent process has been obtained (HREC/16/QRCH/81). The trial has been actively recruiting since May 2017. The study findings will be submitted for publication in a peer-reviewed journal.

Trial registration number


Diabetic foot infection: A critical complication

The number of people in the world with diabetes has nearly quadrupled in the past 40 years. Current data show that 25% of these diabetics will develop a foot ulcer in their lifetime and that the cost of care for a diabetic foot ulcer (DFU) is over twice that of any other chronic ulcer aetiology. Microbial biofilm has been linked to both wound chronicity and infection. Close to 1 in 2 diabetics with a DFU are predicted to go on to develop a diabetic foot infection (DFI). The majority of these DFIs have been found to evolve even before the diabetic individual has received an initial referral for expert DFU management. Of these infected DFUs, less than half have been shown to heal over the next year; many of these individuals will require costly hospitalisation, and current data show that far too many DFIs will require extremity amputation to achieve infection resolution. The development of an infection in a DFU is critical at least in part because paradigms of infection prevention and management are evolving. The effectiveness of our current practice standards is being challenged by a growing body of research related to the prevalence and recalcitrance of the microbes in biofilm to topical and systemic antimicrobials. This article will review the magnitude of current challenges related to DFI prevention and management along with what is currently considered to be standard of care. These ideas will be compared and contrasted with what is known about the biofilm phenotype; then, considerations to support progress towards the development of more cost‐effective protocols of care are highlighted.

A Qualitative, Systems Thinking Approach to Study Self-Management in Women With Migraine

imageBackground A dearth of effective and affordable treatment options has rendered nonpharmacological self-management a crucial part of living with migraine—a debilitating neurobiological condition without cure that disproportionately disables vulnerable women. Objective The aim of the study was to describe the development and use of a systems thinking, problem-structuring data collection approach that was applied to the study of migraine self-management with women in diverse social locations. Methods Two systems mapping activities were developed for use in focus groups: one to unpack a migraine episode (system support map) and the other (connection circle [CC]) to construct a mental model of self-management. Later in the process, a strengths-based problem-solving tool was developed to replace the CC. Results The CCs—often enlightening for affluent participants—left marginalized women feeling overwhelmed and defeated, as a solution to one challenge became the cause of another. Through constant comparison analysis, we recalibrated the approach using a theory, clinical experience, and participant feedback and replaced the CC with a strengths-based problem-solving activity highlighting relationships and trade-offs in a more agential, actionable way. Discussion Bringing a critical lens and strengths-based approaches to work with vulnerable populations can replace traditional deficit thinking in healthcare, developing options for leveraging resources and understanding complex health behaviors without losing sight of systemic, distributional justice issues. These systems thinking tools can provide a way to extrapolate the complexities of actual self-management behaviors and challenges faced by vulnerable women with migraine versus what they may be instructed to do by a medical model that does not always account for the social and structural determinants of equity and health.