Social structures of science and approaches to outcomes-based medical research

Recently, two seemingly divergent approaches have emerged in outcomes-based medical research. Proponents of evidence-based medicine (EBM) argue that the most effective treatments will be found by adopting a hierarchical approach that gives pre-eminence to randomized controlled clinical trials, where these are available. Proponents of participatory medical research argue that research undertaken with consumers and other partners in the community will produce the best outcomes. While one approach marginalizes consumer experience the other approach draws consumers into it. EBM assumes a high level of consensus in a scientific community, while participatory medical research relies on co-opting consumer experience. This paper indicates that each approach involves a particular view of social structure in science. The paper uses theories of social relations among scientists for the purpose of critically assessing EBM and the participatory model.

Australian legal regime on animal based bio-medical research

This thesis, by using evaluative criteria based on overseas law, scientific evidence, philosophy and ethics, concluded that the Australian legal regime regarding animal based bio-medical research for human benefit only partly met one of that regime's major objectives of adequately protecting research animals during the entire research process.

Are the potential benefits of a community-based participatory approach to public health research worth the potential cost?

Much of public health research is conducted in a community setting or is designed to target particular population groups. Community-based participatory research (CBPR) is gaining recognition as good practice in studies of this type(Flicker et al 2007). Its merit is based on the inclusion of the community as active participants at all stages of the research process (Goodman 2006). The focus on justice and equity in this approach is seen to contribute to a range of additional potential research benefits including increased relevance and sustainability of interventions arising from the research ( Blumenthal 2004; Wallestein 2006) However, it is widely acknowledged that adoption of a consciously CBPR approach requires additional expertise. time and resources from researchers and from communities (Tanjasiri et al 2002; Massaro & Claiborne 2001; Israel et al 1998). Adoption of CBPR is also limited by existing infrastructures which are supportive of more· traditional models of research. Changes to professional development programs, funding guidelines and criteria. grant review processes and ethics requirements are needed to support increased application of this approach (Israel et al 2001). As all research resources are limited, the potential additional benefits offered by CBPR over and above a more traditional research approach need to be weighed against the potential additional costs involved. Changes to research infrastructure are unlikely to occur until the costs and
benefits of a consciously CBPR approach as compared to a more traditional research approach can be demonstrated.

This is an exploratory paper that summarises the arguments put forward to date in relation to CBPR. A research case study and an evaluation framework are then used for a conceptual analysis of differences in the potential costs and benefits of the two approaches. Firstly, the paper describes the differences between traditional and consciously CBPR approaches. The reported benefits of CBPR are then outlined, followed by a discussion of the potential costs. Finally, the potential costs are compared to the potential benefits of using a CBPR approach, using a case study of existing research.

Spurious precision : variability in procedural validity of diagnostic procedures in psychotic disorders and implications for research and treatment

Very few studies have quantified the level of agreement among alternative diagnostic procedures that use a common set of fixed operational criteria. The authors examined the procedural validity of four independent methods of assigning DSM-III-R diagnoses of psychotic disorders. METHOD: The research was conducted as a satellite study to the DSM-IV Field Trial for Schizophrenia and Related Psychotic Disorders. The setting was the National Health and Medical Research Council Schizophrenia Research Unit's Early Psychosis Prevention and Intervention Centre, which focuses on first-episode psychosis. Consecutively admitted patients (N = 50) were assessed by independent raters who used four different procedures to determine a DSM-III-R diagnosis. These procedures were 1) the diagnostic instrument developed for the DSM-IV field trial, 2) the Royal Park Multidiagnostic Instrument for Psychosis, 3) the Munich Diagnostic Checklists, and 4) a consensus DSM-III-R diagnosis assigned by a team of clinician researchers who were expert in the use of diagnostic criteria. RESULTS: Concordance between pairs of diagnostic procedures was only moderate. Corresponding levels of percent agreement, however, ranged from 66% to 76%, with converse misclassification rates of 24%-34% (assuming one procedure to be "correct"). CONCLUSIONS: These findings have significant research and clinical implications. Despite the introduction of operationally defined diagnoses, there remained an appreciable level of differential classification or misclassification arising from variability in the method of assigning the diagnostic criteria rather than the criteria themselves. Such misclassification may impede neurobiological research and have harmful clinical effects on patients with first-episode psychosis.

Genetic research in Aboriginal and Torres Strait Islander communities : continuing the conversation

Genetics is at the forefront of medical research, but it is rarely used in Indigenous health research projects. This discussion paper is the outcome of the first ever national discussion of the conduct of genetic research in Indigenous communities in Australia convened by the Lowitja Institute in 2010. It reviews the ethical issues relevant to genetic research in an Australian Indigenous context; existing guidelines for genetic research in indigenous communities internationally; and literature on genetic literacy in Indigenous contexts. Finally, the discussion paper presents a summary of the productive and challenging conversations at the round table.

Data Integration Protocol In Ten-steps (DIPIT) : a new standard for medical researchers

The exponential increase in data, computing power and the availability of readily accessible analytical software has allowed organisations around the world to leverage the benefits of integrating multiple heterogeneous data files for enterprise-level planning and decision making. Benefits from effective data integration to the health and medical research community include more trustworthy research, higher service quality, improved personnel efficiency, reduction of redundant tasks, facilitation of auditing and more timely, relevant and specific information. The costs of poor quality processes elevate the risk of erroneous outcomes, an erosion of confidence in the data and the organisations using these data. To date there are no documented set of standards for best practice integration of heterogeneous data files for research purposes. Therefore, the aim of this paper is to describe a set of clear protocol for data file integration (Data Integration Protocol In Ten-steps; DIPIT) translational to any field of research.

All in the blood: a review of Aboriginal Australians' cultural beliefs about blood and implications for biospecimen research

Public participation in medical research and biobanking is considered key to advances in scientific discovery and translation to improved health care. Cultural concerns relating to blood have been found to affect the participation of indigenous peoples and minorities in research, but such concerns are rarely specified in the literature. This article presents a review of the role of blood in Australian Aboriginal cultures. We discuss the range of meanings and uses of blood in traditional culture, including their use in ceremonies, healing, and sorcery. We draw on more recent literature on Aboriginal Australians and biomedicine to consider how traditional beliefs may be changing over time. These findings provide an empirical basis for researchers and bioethicists to develop culturally grounded strategies to boost the participation of Aboriginal Australians in biomedical research. They also serve as a model for integrating anthropological literature with bioethical concerns that could be applied to other indigenous and minority groups.

Addressing migration-related social and health inequalities in Australia: call for research funding priorities to recognise the needs of migrant populations

Objective Migrants constitute 26% of the total Australian population and, although disproportionately affected by chronic diseases, they are under-represented in health research. The aim of the present study was to describe trends in Australian Research Council (ARC)- and National Health and Medical Research Council (NHMRC)-funded initiatives from 2002 to 2011 with a key focus on migration-related research funding.Methods Data on all NHMRC- and ARC-funded initiatives between 2002 and 2011 were collected from the research funding statistics and national competitive grants program data systems, respectively. The research funding expenditures within these two schemes were categorised into two major groups: (1) people focused (migrant-related and mainstream-related); and (2) basic science focused. Descriptive statistics were used to summarise the data and report the trends in NHMRC and ARC funding over the 10-year period.Results Over 10 years, the ARC funded 15 354 initiatives worth A$5.5 billion, with 897 (5.8%) people-focused projects funded, worth A$254.4 million. Migrant-related research constituted 7.8% of all people-focused research. The NHMRC funded 12 399 initiatives worth A$5.6 billion, with 447 (3.6%) people-focused projects funded, worth A$207.2 million. Migrant-related research accounted for 6.2% of all people-focused initiatives.Conclusions Although migrant groups are disproportionately affected by social and health inequalities, the findings of the present study show that migrant-related research is inadequately funded compared with mainstream-related research. Unless equitable research funding is achieved, it will be impossible to build a strong evidence base for planning effective measures to reduce these inequalities among migrants.What is known about the topic? Immigration is on the rise in most developing countries, including Australia, and most migrants come from low- and middle-income countries. In Australia, migrants constitute 26% of the total Australian population and include refugee and asylum seeker population groups. Migrants are disproportionately affected by disease, yet they have been found to be under-represented in health research and public health interventions.What does this paper add? This paper highlights the disproportions in research funding for research among migrants. Despite migrants being disproportionately affected by disease burden, research into their health conditions and risk factors is grossly underfunded compared with the mainstream population.What are the implications for practitioners? Migrants represent a significant proportion of the Australian population and hence are capable of incurring high costs to the Australian health system. There are two major implications for practitioners. First, the migrant population is constantly growing, therefore integrating the needs of migrants into the development of health policy is important in ensuring equity across health service delivery and utilisation in Australia. Second, the health needs of migrants will only be uncovered when a clear picture of their true health status and other determinants of health, such as psychological, economic, social and cultural, are identified through empirical research studies. Unless equitable research funding is achieved, it will be impossible to build a strong evidence base for planning effective measures to reduce health and social inequalities among migrant communities.

Speed up health research through topic modeling of coded clinical data

Although random control trial is the gold standard in medical research, researchers are increasingly looking to alternative data sources for hypothesis generation and early-stage evidence collection. Coded clinical data are collected routinely in most hospitals. While they contain rich information directly related to the real clinical setting, they are both noisy and semantically diverse, making them difficult to analyze with conventional statistical tools. This paper presents a novel application of Bayesian nonparametric modeling to uncover latent information in coded clinical data. For a patient cohort, a Bayesian nonparametric model is used to reveal the common comorbidity groups shared by the patients and the proportion that each comorbidity group is reflected individual patient. To demonstrate the method, we present a case study based on hospitalization coding from an Australian hospital. The model recovered 15 comorbidity groups among 1012 patients hospitalized during a month. When patients from two areas of unequal socio-economic status were compared, it reveals higher prevalence of diverticular disease in the region of lower socio-economic status. The study builds a convincing case for routine coded data to speed up hypothesis generation.

Navigating the ethics of cross-cultural health promotion research

Health promotion researchers must consider the ethics of their research, and are usually required to abide by a set of ethical requirements stipulated by governing bodies (such as the Australian National Health and Medical Research Council) and human research ethics committees (HRECs). These requirements address both deontological (rule-based) and consequence-based issues. However, at times there can be a disconnect between the requirements of deontological issues and the cultural sensitivity required when research is set in cultural contexts and settings etic to the HREC. This poses a challenge for health promotion researchers who must negotiate between meeting both the requirements of the HREC and the needs of the community with whom the research is being conducted. Drawing on two case studies, this paper discusses examples from cross-cultural health promotion research in Australian and international settings where disconnect arose and negotiation was required to appropriately meet the needs of all parties. The examples relate to issues of participant recruitment and informed consent, participants under the Australian legal age of consent, participant withdrawal when this seemingly occurs in an ad hoc rather than a formal manner and reciprocity. Although these approaches are context specific, they highlight issues for consideration to advance more culturally appropriate practice in research ethics and suggest ways a stronger anthropological lens can be applied to research ethics to overcome these challenges.

The Centre of Clinical Research Excellence in Aboriginal Health : an operational rationale and some reflections on progress so far

The Centre of Clinical Research Excellence (CCRE) in Aboriginal and Torres Strait Islander Health was established in late 2003 through a major National Health and Medical Research Council (NHMRC) grant involving collaboration between the Aboriginal Health Council of South Australia (AHCSA), Flinders University, and Aboriginal Health Services. Our foundation research communities are the Aboriginal communities served by these Aboriginal Health Services in the Spencer Gulf / Eyre Peninsula region. In recent years a number of collaborative research programs involving chronic illness management, self-management and coordinated care have been implemented in these communities and this work is the basis of the initial CCRE activities. Key objectives of the CCRE are to improve the health status of Indigenous people through conducting relevant and meaningful Aboriginal controlled health research, providing formal training for Indigenous health researchers and developing innovative approaches to health care that can be readily translated and applied to support communities. The inclusion, empowerment and engagement of Indigenous people in the process of managing community health represent tangible strategies for achieving more equitable health outcomes for Aboriginal people. This paper outlines the CCRE operational rationale and presents early activities and outcomes across the three strategic areas of CCRE operations: research, education and training, and translation. Some critical reflections are offered on the progress and experience of the CCRE thus far. A common obstacle this CCRE has encountered is that the limited (especially staff) resources available to the Aboriginal Health Services with which we are collaborating make it difficult for them to engage with and progress the projects we are pursuing.

Changes in intravenous fluid use patterns in Australia and New Zealand: evidence of research translating into practice

OBJECTIVES: To describe changes in the use of intravenous (IV) fluid by quantity and type in different regions of Australia and New Zealand. DESIGN, SETTING AND PARTICIPANTS: We conducted a retrospective ecological study examining regional and temporal trends in IV fluid consumption across Australia and New Zealand over the periods 2012-2013 and 2013- 2014, using national proprietary sales data as a surrogate for consumption, and demographic data from the public domain. RESULTS: More than 13.3 million litres of IV fluid were consumed in Australia and New Zealand in 2012-2013, and more than 13.9 million litres in 2013-2014, with colloid solutions accounting for < 2%. There was marked regional variation in consumption of fluids, by volumes and proportions used, when standardised to overall Australian and New Zealand values. There was no significant change in the overall volume of crystalloid solutions consumed but there was a significant decrease (9%; P = 0.02) in the ratio of unbalanced to balanced crystalloid solutions consumed. Consumption of all forms of colloid solutions decreased, with a 12% reduction overall (P = 0.02), primarily driven by a 67% reduction in the consumption of hydroxyethyl starch (HES) solutions. CONCLUSIONS: The amount and type of IV fluid use, as determined by fluid sales, is highly variable across Australia and New Zealand. However, overall use of balanced crystalloid solutions is increasing and the use of HES has decreased dramatically.

Short form health surveys and related variants in spinal cord injury research : a systematic review

CONTEXT: 'Short Form' health surveys - such as the SF-36 and SF-12 - are widely used in medical research. Spinal cord injury (SCI) is no exception, despite oft-cited concerns regarding measurement properties for populations with physical impairment.OBJECTIVE: To provide a comprehensive overview of the use of Short Form health surveys and their variants within the SCI literature.METHODS: Papers published between database inception and September 2012 were identified from 11 electronic databases; a supplementary reference list search was also conducted. Data extraction focused on details regarding the range of different Short Form surveys and variants used in SCI research, the respective frequency of use, the nature of reporting (complete versus partial reporting) and the method of survey administration.RESULTS: One hundred seventy-four papers were identified. Thirty-six-item Short Form health surveys were frequently administered as complete instruments (n = 82); in 69 of these 82 studies (84%), it was not clearly stated which 36-item version had been used (e.g. SF-36v1, SF-36v2, RAND-36). Data for individual items and domains were often reported (29% of identified studies), indicating significant partial use of standardized measures. Modified variants of standardized health surveys were administered in 12 studies.CONCLUSION: Although standardized Short Form health surveys are common within SCI research, attempts to add, delete, or modify items have resulted in a number of variants, often with minimal supportive psychometric evidence. Using established, generic outcome measures is appealing for a number of reasons. However, validity is paramount and requires further explicit consideration within the SCI research community.

Acute pain management: Implications of scientific evidence for nursing practice in the postoperative context

Unrelieved acute pain remains prevalent in hospitalized patients despite advances in pain management. A decade after the Australian National Health and Medical Research Council called for improved pain management practices by health professionals, it released clinical guidelines to provide clinicians with current scientific evidence to augment their clinical decision-making. This paper examines the implications of national guidelines on nursing practice and highlights the inadequacies of current implementation policies. Pain management guidelines have failed to decrease patients' postoperative pain because organizations and researchers have ignored the impact of contextual influences on clinicians' decision-making. It is recommended that for successful implementation of national guidelines to occur at the local level of practice, organizations must assist clinicians to identify local influences on their decision-making, to address the issues specific to their own work environment and to evaluate any changes in practice.