Paying clinicians to join clinical trials : a review of guidelines and interview study of trialists

Background: The motivations of clinicians to participate in clinical trials have been little studied. This project explored the potential role of payment for participation in publicly funded clinical trials in the UK. The aims were to review relevant guidelines and to collate and analyse views of clinical trialists on the role of payments and other factors that motivated clinicians to join clinical trials. Methods: Review of guidelines governing payments to clinicians for recruitment to trials. Semistructured interviews with a range of NHS clinical trial leaders, analysed using qualititative methods. Results: While UK guidelines had little to say specifically on payments linked to recruitment, all payments have become highly regulated and increasingly transparent. Interview participants believed that expenses arising from research should be covered. Payments in excess of expenses were seen as likely to increase participation but with the risk of reducing quality. Motivations such as interest in the topic, the scope for patients to benefit and intellectual curiosity were considered more important. Barriers to involvement included bureaucracy and lack of time. Discussion: Limited scope exists for paying clinicians over-and-above the cost of their time to be involved in research. Most trialists favour full payment of all expenses related to research. Conclusion: Payment of clinicians beyond expenses is perceived to be a less important motivating factor than researching important, salient questions, and facilitating research by reducing bureaucracy and delay

Operationalising a model framework for consumer and community participation in health and medical research

The Consumers' Health Forum of Australia and the National Health and Medical Research Council has recently developed a Model Framework for Consumer and Community Participation in Health and Medical Research in order to better align health and medical research with community need, and improve the impact of research. Model frameworks may have little impact on what goes on in practice unless relevant organisations actively make use of them. Philanthropic and government bodies have reported involving consumers in more meaningful or collaborative ways of late. This paper describes how a large charity organisation, which funds a significant proportion of Australian cancer research, operationalised the model framework using a unique approach demonstrating that it is both possible and reasonable for research to be considerate of public values

Local reactions after the fourth-dose of acellular pertussis vaccine in South Australia

The document attached has been archived with permission from the editor of the Medical Journal of Australia. An external link to the publisher’s copy is included.ObjectiveTo assess the reported rate of local reactions after administration of acellular pertussis vaccine (DTPa) according to dose number and type of pertussis vaccine (whole-cell or acellular) used for the primary course, and to document the severity and outcome of fourth-dose local reactions.Design and settingRetrospective review. Reports of adverse events after vaccination in South Australia between 1 January 1997 and 31 December 2000 were reviewed, and a questionnaire administered to all parents who reported a local reaction after the fourth dose of DTPa.Main outcome measuresThe number, and rate per 100 000 administered doses, of local reactions following the primary and booster doses of DTPa, and of local reactions after the fourth-dose in cohorts of children whose primary vaccinations were with either DTPw or DTPa. Redness and/or swelling at the injection site as reported by parents.ResultsOf 581 reported adverse events after vaccination, 138 were local reactions after a pertussis-containing vaccine. Primary vaccinations with DTPa was a significant risk factor for a fourth-dose local reaction (relative risk, 6.7; 95% CI, 2.4-18.5). Parental questionnaires were completed for 45 of the 71 children (63%) with reported local reactions after the fourth dose of DTPa; extensive limb swelling was reported in 8 children (18%) and all except one child had recovered by the time of review.ConclusionsParents should be informed that children receiving booster doses of DTPa vaccine, after primary doses with DTPa, are at increased risk of local reactions (which tend to resolve spontaneously) but not of systemic effects. Studies should be initiated to investigate the pathogenesis and the risk of recurrence of local reactions to further improve vaccination schedules.Michael S Gold, Sara Noonan, Maggi Osbourn, Stella Precepa and Ann E Kemp

Prevention of non-communicable diseases in Pakistan: an integrated partnership-based model

Development and implementation of non-communicable disease (NCD) prevention polices in the developing countries is a multidimensional challenge. This article highlights the evolution of a strategic approach in Pakistan. The model is evidence-based and encompasses a concerted and integrated approach to NCDs. It has been modelled to impact a set of indicators through the combination of a range of actions capitalizing on the strengths of a public-private partnership. The paper highlights the merits and limitations of this approach. The experience outlines a number of clear imperatives for fostering an enabling environment for integrated NCD prevention public health models, which involve roles played by a range of stakeholders. It also highlights the value that such partnership arrangements bring in facilitating the mission and mandates of ministries of health, international agencies with global health mandates, and the non-profit private sector. The experience is of relevance to developing countries that have NCD programs running and those that need to develop them. It provides an empirical basis for enhancing the performance of the health system by fostering partnerships within integrated evidence-based models and permits an analysis of health systems models built on shared responsibility for the purpose of providing sustainable health outcomes

Exploring productivity and collaboration in Australian Indigenous health research, 1995-2008

BACKGROUND Building research capacity in Indigenous health has been recognised as integral in efforts to reduce the significant health disparities between Indigenous and other Australian populations. The past few decades have seen substantial changes in funding policy for Australian Indigenous health research, including increases in overall expenditure and a greater focus on collaborative and priority-driven research. However, whether these policy shifts have resulted in any change to the structure of the research workforce in this field is unclear. We examine research publications in Australian Indigenous health from 1995–2008 to explore trends in publication output, key themes investigated, and research collaborations. METHODS A comprehensive literature search was undertaken to identify research publications about Australian Indigenous health from 1995–2008. Abstracts of all publications identified were reviewed by two investigators for relevance. Eligible publications were classified according to key themes. Social network analyses of co-authorship patterns were used to examine collaboration in the periods 1995–1999, 2000–2004 and 2005–2008. RESULTS Nine hundred and fifty three publications were identified. Over time, the number of publications per year increased, particularly after 2005, and there was a substantial increase in assessment of health service-related issues. Network analyses revealed a highly collaborative core group of authors responsible for the majority of outputs, in addition to a series of smaller separate groups. In the first two periods there was a small increase in the overall network size (from n = 583 to n = 642 authors) due to growth in collaborations around the core. In the last period, the network size increased considerably (n = 1,083), largely due to an increase in the number and size of separate groups. The general size of collaborations also increased in this period. CONCLUSIONS In the past few decades there has been substantial development of the research workforce in Indigenous health, characterised by an increase in authors and outputs, a greater focus on some identified priority areas and sustained growth in collaborations. This has occurred in conjunction with significant changes to funding policy for Indigenous health research, suggesting that both productivity and collaboration may be sensitive to reform, including the provision of dedicated funding.Alice R Rumbold, Joan Cunningham, Brydie Purbrick and Jenny M Lewi

Experiences of expressing and storing colostrum antenatally: A qualitative study of mothers in regional Western Australia

This qualitative study explored the experiences and breastfeeding outcomes of a group of mothers who expressed colostrum in the antenatal period. In-depth interviews were conducted over the telephone with 12 women who had attended a unique antenatal lactation clinic appointment at 37 weeks’ gestation. Seven main response themes were identified. Most women reflected positively upon their attendance and reported that the experience of expressing colostrum allowed them to become familiar with their breasts and gave them a sense of security by having a supply of colostrum stored for possible use after birth. The main negative emotions reported were a sense of embarrassment at expressing the colostrum, particularly in front of another person, the difficulties with expressing colostrum and in one instance, the physical pain associated with the process. Antenatal expression of colostrum may improve maternal breastfeeding confidence. Further research using long-term records will determine whether this practice improves breastfeeding outcomes

Collaborating with consumer and community representatives in health and medical research in Australia: results from an evaluation

<p>Abstract</p> <p>Objective</p> <p>To collaborate with consumer and community representatives in the <it>Alcohol and Pregnancy Project </it>from 2006-2008 <url>http://www.ichr.uwa.edu.au/alcoholandpregnancy</url> and evaluate researchers' and consumer and community representatives' perceptions of the process, context and impact of consumer and community participation in the project.</p> <p>Methods</p> <p>We formed two reference groups and sought consumer and community representatives' perspectives on all aspects of the project over a three year period. We developed an evaluation framework and asked consumer and community representatives and researchers to complete a self-administered questionnaire at the end of the project.</p> <p>Results</p> <p>Fifteen researchers (93.8%) and seven (53.8%) consumer and community representatives completed a questionnaire. Most consumer and community representatives agreed that the process and context measures of their participation had been achieved. Both researchers and consumer and community representatives identified areas for improvement and offered suggestions how these could be improved for future research. Researchers thought consumer and community participation contributed to project outputs and outcomes by enhancing scientific and ethical standards, providing legitimacy and authority, and increasing the project's credibility and participation. They saw it was fundamental to the research process and acknowledged consumer and community representatives for their excellent contribution. Consumer and community representatives were able to directly influence decisions about the research. They thought that consumer and community participation had significant influence on the success of project outputs and outcomes.</p> <p>Conclusions</p> <p>Consumer and community participation is an essential component of good research practice and contributed to the <it>Alcohol and Pregnancy Project </it>by enhancing research processes, outputs and outcomes, and this participation was valued by community and consumer representatives and researchers. The National Health and Medical Research Council in Australia expects researchers to work in partnership and involve consumer and community representatives in health and medical research, and to evaluate community and consumer participation. It is important to demonstrate whether consumer and community participation makes a difference to health and medical research.</p

What are the required elements needed to create an effective visual art intervention for people with dementia? A qualitative exploration

Background: This paper aims to advance understanding of ‘what works’ in visual art interventions from the perspective of key stakeholders’, including people with dementia, their family members and visual art professionals. Method: Semi-structured interviews were conducted with 22 participants, exploring their perceptions on barriers, facilitators, perceived benefits, experiences of delivering/attending a visual art intervention, and any recommendations for implementation. Results: Five factors were identified within the interviews that indicated important considerations for intervention structure and implementation, including: benefits of group work, a skilled facilitator, participant choice, artistic ability, and activity content. Whilst art therapists expressed a clear protection of professional boundaries, the success of all of the visual art interventions was largely attributed to the supportive facilitator who possessed certain core values such as empathy and compassion and had knowledge in both artistic practice and the impact of living with dementia. It was clear the group dynamic was valued, and it was important to provide enjoyable, failure-free activity content with a strong focus on the creative process. Conclusion: These findings offer a direction for evidence-based practice when implementing visual art interventions