Medical Research Council Guidelines Research Articles

Burn injury models of care: A review of quality and cultural safety for care of Indigenous children

Safety and quality in the systematic management of burn care is important to ensure optimal outcomes. It is not clear if or how burn injury models of care uphold these qualities, or if they provide a space for culturally safe healthcare for Indigenous peoples, especially for children. This review is a critique of publically available models of care analysing their ability to facilitate safe, high-quality burn care for Indigenous children. Models of care were identified and mapped against cultural safety principles in healthcare, and against the National Health and Medical Research Council standard for clinical practice guidelines. An initial search and appraisal of tools was conducted to assess suitability of the tools in providing a mechanism to address quality and cultural safety. From the 53 documents found, 6 were eligible for review. Aspects of cultural safety were addressed in the models, but not explicitly, and were recorded very differently across all models. There was also limited or no cultural consultation documented in the models of care reviewed. Quality in the documents against National Health and Medical Research Council guidelines was evident; however, description or application of quality measures was inconsistent and incomplete. Gaps concerning safety and quality in the documented care pathways for Indigenous peoples’ who sustain a burn injury and require burn care highlight the need for investigation and reform of current practices.

Quality of development and reporting of dietetic intervention studies in primary care: a systematic review of randomised controlled trials.

High-quality research methodologies and clear reporting of studies are essential to facilitate confidence in research findings. The aim of the present study was to conduct an in-depth examination of the methodological quality and reporting of studies included in a recent systematic review of dietitians' effectiveness at providing individualised nutrition care to adult patients. The methodological quality and reporting of 27 Randomised Controlled Trials (RCTs) were appraised using the UK Medical Research Council (MRC) Guidelines for complex interventions and the CONSORT checklist for reporting RCTs. A quality appraisal checklist was developed for each guideline/assessment tool aiming to evaluate the extent to which each study met the designated criteria. Excerpts from studies that best addressed criteria were collated to provide exemplary accounts of how criteria may be achieved in future studies. None of the reviewed studies met more than half of the MRC Guidance criteria, indicating that there is clear room for improvement in reporting the methodological underpinnings of these studies. Similarly, no studies met all criteria of the CONSORT checklist, suggesting that there is also room for improvement in the design and reporting of studies in this field. Dietitians, researchers and journal editors are encouraged to use the results and exemplary accounts from this review to identify key aspects of studies that could be improved in future research. Improving future research will enhance the quality of the evidence-base that investigates the outcomes of dietary interventions involving dietitians.

The Indigenous Counselling and Nicotine (ICAN) QUIT in Pregnancy Pilot Study protocol: a feasibility step-wedge cluster randomised trial to improve health providers' management of smoking during pregnancy

IntroductionIndigenous women have the highest smoking prevalence during pregnancy (47%) in Australia. Health professionals report lack of knowledge, skills and confidence to effectively manage smoking among pregnant women in general....

PREPARE OLDER PATIENTS FOR CARDIAC SURGERY: DEVELOPMENT AND FEASIBILITY OF A NURSING INTERVENTION

Abstract Background and aim: In older patients undergoing elective cardiac surgery, timely identification and preparation of patients at risk for frequent postoperative hospital complications provides for the opportunity reducing their risk. We developed an evidence based multi component nursing intervention (PREDOCS-Program) to improve patients’ physical and psychosocial condition in order to reduce their risk on postoperative complications and we tested the PREDOCS-program on its feasibility and estimated theoretical cost savings. Method and material: In a team of researchers, experts, cardiac surgeons, cardiac surgery nurses and patients, the first phase of the revised guidelines for developing and evaluating complex interventions of the Medical Research Council (MRC) were followed. Subsequently, in a mixed-methods multicenter study, following the second phase of the MRC guidelines, we tested the feasibility in three hospitals and calculated theoretical cost savings. Results: PREDOCS-program is administered during a consult by the nurse, two to four weeks before the surgery procedure. Twenty one females and 49 males out of the 114 eligible patients completed the intervention. Patients were equally satisfied with the usual care and the PREDOCS-program (satisfaction rates on a scale from 1–10 respectively: 7.5 (95%CI: 6.4–8.7) and 7.6 (6.6–8.6)). The PREDOCS-program will be cost-effective when postoperative complications are prevented in six to sixteen of 1,000 cardiac surgery patients. Conclusion: In creating transparency in the assumed working mechanisms, an extended stepwise multi-method procedure was used to develop the PREDOCS-program, which will be already cost-effective when postoperative complications are prevented in six to sixteen of 1000 cardiac surgery patients.

Population estimates and characteristics of Australians potentially eligible for bariatric surgery: findings from the 2011-13 Australian Health Survey.

Objective The aim of the present study was to determine the potential demand for publicly and privately funded bariatric surgery in Australia. Methods Nationally representative data from the 2011-13 Australian Health Survey were used to estimate the numbers and characteristics of Australians meeting specific eligibility criteria as recommended in National Health and Medical Research Council guidelines for the management of overweight and obesity. Results Of the 3352037 adult Australians (aged 18-65 years) estimated to be obese in 2011-13, 882441 (26.3%; 95% confidence interval (CI) 23.0-29.6) were potentially eligible for bariatric surgery (accounting for 6.2% (95% CI 5.4-7.1) of the adult population aged 18-65 years (n=14122020)). Of these, 396856 (45.0%; 95% CI 40.4-49.5) had Class 3 obesity (body mass index (BMI) ≥40kgm-2), 470945 (53.4%; 95% CI 49.0-57.7) had Class 2 obesity (BMI 35-39.9kgm-2) with obesity-related comorbidities or risk factors and 14640 (1.7%; 95% CI 0.6-2.7) had Class 1 obesity (BMI 30-34.9kgm-2) with poorly controlled type 2 diabetes and increased cardiovascular risk; 458869 (52.0%; 95% CI 46.4-57.6) were female, 404594 (45.8%; 95% CI 37.3-54.4) had no private health insurance and 309983 (35.1%; 95% CI 28.8-41.4) resided outside a major city. Conclusion Even if only 5% of Australian adults estimated to be eligible for bariatric surgery sought this intervention, the demand, particularly in the public health system and outside major cities, would far outstrip current capacity. Better guidance on patient prioritisation and greater resourcing of public surgery are needed. What is known about this topic? In the period 2011-13, 4million Australian adults were estimated to be obese, with obesity disproportionately more prevalent in areas of socioeconomic disadvantage. Bariatric surgery is considered to be cost-effective and the most effective treatment for adults with obesity, but is mainly privately funded in Australia (>90%), with 16650 primary privately funded procedures performed in 2015. The extent to which the supply of bariatric surgery is falling short of demand in Australia is unknown. What does this paper add? The present study provides important information for health service planners. For the first time, population estimates and characteristics of those potentially eligible for bariatric surgery in Australia have been described based on the best available evidence, using categories that best approximate the national recommended eligibility criteria. What are the implications for practitioners? Even if only 5% of those estimated to be potentially eligible for bariatric surgery in Australia sought a surgical pathway (44122 of 882441), the potential demand, particularly in the public health system and outside major cities, would still far outstrip current capacity, underscoring the immediate need for better guidance on patient prioritisation. The findings of the present study provide a strong signal that more funding of public surgery and other effective interventions to assist this population group are necessary.

Identifying mechanisms of change in a conversation therapy for aphasia using behaviour change theory and qualitative methods.

BackgroundConversation therapy for aphasia is a complex intervention comprising multiple components and targeting multiple outcomes. UK Medical Research Council (MRC) guidelines published in 2008 recommend that in addition to measuring the outcomes of complex interventions, evaluation should seek to clarify how such outcomes are produced, including identifying the hypothesized mechanisms of change.AimsTo identify mechanisms of change within a conversation therapy for people with aphasia and their partners. Using qualitative methods, the study draws on behaviour change theory to understand how and why participants make changes in conversation during and after therapy.Methods & ProceduresData were derived from 16 participants (eight people with aphasia; eight conversation partners) who were recruited to the Better Conversations with Aphasia research project and took part in an eight session conversation therapy programme. The dataset consists of in‐therapy discussions and post‐therapy interviews, which are analysed using Framework Analysis.Outcomes & ResultsSeven mechanisms of conversational behaviour change are identified and linked to theory. These show how therapy can activate changes to speakers’ skills and motivation for using specific behaviours, and to the conversational opportunities available for strategy use.Conclusions & ImplicationsThese clinically relevant findings offer guidance about the processes involved in producing behavioural change via conversation therapy. A distinction is made between the process involved in motivating change and that involved in embedding change. Differences are also noted between the process engaged in reducing unhelpful behaviour and that supporting new uses of compensatory strategies. Findings are expected to have benefits for those seeking to replicate therapy's core processes both in clinical practice and in future research.

Individual placement and support (IPS) for patients with offending histories: the IPSOH feasibility cluster randomised trial protocol

IntroductionPeople with involvement in forensic psychiatric services face many obstacles to employment, arising from their offending, as well as their mental health problems. This study aims to assess the feasibility...

Etiology of molar incisor hypomineralization - A systematic review.

Molar incisor hypomineralization (MIH) is a common developmental dental defect of permanent teeth, which can increase the risk of dental caries, infection and hospitalization. The etiology is currently unclear although prenatal or early childhood health factors are suspected. The aim of this systematic review was to assess the strength of evidence linking etiological factors with MIH. A systematic search was conducted using the Medline and Embase electronic databases for studies investigating environmental etiological factors of MIH. Two reviewers assessed the eligibility of studies. The level of evidence and bias was determined for all eligible studies according to Australian National Health and Medical Research Council guidelines for systematic reviews of etiology and the Newcastle-Ottawa Scale. From a total of 2254 studies identified through electronic and hand searching, 28 were eligible for inclusion. Twenty-five of these investigated MIH and three investigated a related condition in primary teeth, hypomineralized second primary molars (HSPM), and these were analysed separately. A limited number of studies reported significant associations between MIH and pre- and perinatal factors such as maternal illness and medication use in pregnancy, prematurity and birth complications. Early childhood illness was implicated as an etiological factor in MIH in several studies, in particular fever, asthma and pneumonia. The studies investigating HSPM revealed an association with maternal alcohol consumption, infantile fever and ethnicity. However, the validity of these findings is impaired by study design, lack of adjustment for confounders, lack of detail and consistency of exposures investigated and poor reporting. Childhood illness is likely to be associated with MIH. Further prospective studies of the etiology of MIH/HSPM are needed.

Cancer-related fatigue: appraising evidence-based guidelines for screening, assessment and management.

There is inconsistent management of cancer-related fatigue (CRF) by health professionals worldwide. This research aims to identify the most appropriate guidelines for the management of cancer-related fatigue. A systematic search of international literature identified evidence-based clinical practice guidelines for CRF. Four reviewers independently appraised the highest quality guidelines using the AGREE-II instrument and National Heath and Medical Research Council (NHMRC) guideline standards. Five guidelines met the inclusion criteria. Of these, the 2015 Canadian Association of Psychosocial Oncology (CAPO) CRF guidelines and the 2014 American Society of Clinical Oncology (ASCO) fatigue guidelines for cancer survivors were selected for in-depth appraisal. The CAPO guideline scored higher than the ASCO for five domains of the AGREE-II. For one domain, the differences were statistically significant (p≤0.05). The CAPO guideline met 37 of 47 NHMRC mandatory guideline standards and the ASCO guideline met 20. The difference in the proportion of standards met was statistically significant for one domain (p≤0.05). Both guidelines had low scores for applicability and implementation. Currently, the CAPO guideline for cancer-related fatigue has the strongest evidence for use. To enhance implementation, further strategies for guideline dissemination and application are needed.

A collaborative process for developing a weight management toolkit for general practitioners in Australia-an intervention development study using the Knowledge To Action framework.

BackgroundObesity is commonly seen in the Australian general practice population; however, few resources are specifically targeted at GPs working with these patients. The National Health and Medical Research Council (Australia) guideline for managing patients who are overweight and obese supports the involvement of a regular health professional. As 85 % of the population visit a GP annually, resources to support GPs working with this patient population are needed.This study describes the collaborative process used to develop an obesity management programme based on current Australian guidelines for GPs and their patients to be used in primary care. The Knowledge To Action framework was applied to develop a weight management toolkit for GPs based on current Australian guidelines. This draft was then reviewed by clinical GPs, GP registrars, consumer representatives and allied health professionals using focus groups and interviews. The participants gave feedback on the content, layout and acceptability of the documents. The feedback from the stakeholder groups was evaluated, and changes were incorporated into the final documents. A graphic designer was contracted to assist with the layout to improve useability and attractiveness of the documents. ResultsA total of 38 participants gave feedback on the draft weight management programme, and the research team amalgamated their responses to further improve the documents. The general response from GPs and consumer representatives was positive with most conveying their wish to try the programme themselves.Conclusions“The Change Program” is a practical tool for Australian GPs to use with their patients who are overweight or obese. It was developed in collaboration with GPs, allied health professionals and consumer stakeholders based on current Australian guidelines. It is currently being piloted in five general practices.

Physiotherapy for cystic fibrosis in Australia and New Zealand: A clinical practice guideline.

Physiotherapy management is a key element of care for people with cystic fibrosis (CF) throughout the lifespan. Although considerable evidence exists to support physiotherapy management of CF, there is documented variation in practice. The aim of this guideline is to optimize the physiotherapy management of people with CF in Australia and New Zealand. A systematic review of the literature in key areas of physiotherapy practice for CF was undertaken. Recommendations were formulated based on National Health and Medical Research Council (Australia) guidelines and considered the quality, quantity and level of the evidence; the consistency of the body of evidence; the likely clinical impact; and applicability to physiotherapy practice in Australia and New Zealand. A total of 30 recommendations were made for airway clearance therapy, inhalation therapy, exercise assessment and training, musculoskeletal management, management of urinary incontinence, managing the newly diagnosed patient with CF, delivery of non‐invasive ventilation, and physiotherapy management before and after lung transplantation. These recommendations can be used to underpin the provision of evidence‐based physiotherapy care to people with CF in Australia and New Zealand.

Critical Reflection in Cultural Competence Development: A Framework for Undergraduate Nursing Education.

Nursing faculties are urged to adopt a curriculum that supports culturally competent care and to mentor students to provide care that promotes social justice, particularly for the marginalized members of society. This article describes the development of a framework for critical reflection in cultural competence development among undergraduate nursing students. Following the Medical Research Council guidelines for developing complex interventions, empirical and theoretical literature was reviewed to define the framework rationale and its components. The resulting framework is grounded in Blanchet Garneau's constructivist model of cultural competence development and Mezirow's transformative learning theory. It clarifies the desired outcomes, the main steps to foster critical reflection among students, and the contextual conditions and prerequisites for teachers and learners. Education oriented toward critical reflective practice promotes a full reflection about Western social and clinical practices and points out the role of nurses in reducing health inequities.

A retrospective observational study for the outcomes of women presenting to a colposcopy clinic with a high-grade Pap smear - Implications for a 'see and treat' approach to management.

The current Australian National Health and Medical Research Council guidelines discourage the use of 'see and treat' colposcopic management due to concerns regarding over-treatment. However, this approach has been shown to have benefits in several studies, including cost savings, elimination of loss to follow up and decreased patient anxiety. To provide Australian data on treatment outcomes for women presenting with a high-grade Pap smear to a large metropolitan colposcopy unit and to determine whether a 'see and treat' approach would meet specified standards. Retrospective review of women referred to the Royal Prince Alfred Hospital colposcopy unit with a high-grade smear. Patient data, colposcopy findings, treatment and pathology results were collated and analysed to determine treatment outcomes using the current 'biopsy and treat' approach. The feasibility of 'see and treat' was assessed by determining which women with high-grade colposcopy findings had high-grade disease confirmed on biopsy or excisional specimens. One hundred and thirty-seven women underwent either excisional or ablative treatment. Of those undergoing excisional procedures, 81.3% had high-grade dysplasia or invasive cancer, 11.6% had CIN1 and 7.1% had no dysplasia on histopathology. One hundred and twenty-one with high-grade colposcopy findings had histopathology results available. Using a 'see and treat' approach, 92.6% would have had confirmed dysplasia of any grade, while 91.7% had confirmed high-grade dysplasia. 'See and treat' colposcopy is feasible in the Australian setting when applied to selected patients with high-grade cytology and high-grade colposcopic findings.

Predictors of awareness of standard drink labelling and drinking guidelines to reduce negative health effects among Australian drinkers.

This study examined rates of awareness of standard drink labelling and drinking guidelines among Australian adult drinkers. Demographic predictors of these two outcomes were also explored. Online survey panel participants aged 18-45 years(n = 1061; mean age = 33.2 years) completed an online survey assessing demographics, alcohol consumption patterns, awareness of standard drink labels and the National Health and Medical Research Council (NHMRC) guidelines, and support for more detailed labels. The majority (80%) of participants had seen standard drink labels on alcohol products; with younger drinkers, those from a regional/rural location and high-risk drinkers significantly more likely to have seen such labelling. Most respondents estimated at or below the maximum number of drinks stipulated in the NHMRC guidelines. However, their estimates of the levels for male drinkers were significantly higher than for female drinkers. High-risk drinkers were significantly less likely to provide accurate estimates, while those who had seen the standard drink logo were significantly more likely to provide accurate estimates of drinking levels to reduce the risk of long-term harms only. Just under three-quarters of respondents supported the inclusion of more information on labels regarding guidelines to reduce negative health effects. The current standard drink labelling approach fails to address high-risk drinkers. The inclusion of information about NHMRC guidelines on alcohol labels, and placing standard drink labelling on the front of products could improve awareness of what constitutes a standard drink and safe levels of consumption among Australian drinkers.[Kerri Coomber, Sandra C. Jones, Florentine Martino, Peter G. Miller. Predictors of awareness of standard drink labelling and drinking guidelines to reduce negative health effects among Australian drinkers. Drug Alcohol Rev 2017;36:200-209].

Improving rural and remote practitioners' knowledge of the diabetic foot: findings from an educational intervention.

BackgroundThis study aimed to determine knowledge of national guidelines for diabetic foot assessment and risk stratification by rural and remote healthcare professionals in Western Australia and their implementation in practice. Assessment of diabetic foot knowledge, availability of equipment and delivery of foot care education in a primary healthcare setting at baseline enabled evaluation of the effectiveness of a diabetic foot education and training program for generalist healthcare professionals.MethodsThis study employed a quasi-experimental pre-test/post-test study design. Healthcare practitioners’ knowledge, attitudes and practice of diabetic foot assessment, diabetic foot risks, risk stratification, and use of the 2011 National Health and Medical Research Council Guidelines were investigated with an electronic pre-test survey. Healthcare professionals then undertook a 3-h education and training workshop before completing the electronic post-test knowledge, attitudes and practice survey. Comparison of pre-test/post-test survey findings was used to assess the change in knowledge, attitudes and intended practice due to the workshops.ResultsTwo hundred and forty-six healthcare professionals from two rural and remote health regions of Western Australia participated in training workshops. Monofilaments and diabetes foot care education brochures, particularly brochures for Aboriginal people, were reported as not readily available in rural and remote health services. For most participants (58 %), their post-test knowledge score increased significantly from the pre-test score. Use of the Guidelines in clinical settings was low (19 %). The healthcare professionals’ baseline diabetic foot knowledge was adequate to correctly identify the high risk category. However, stratification of the intermediate risk category was poor, even after training.ConclusionThis study reports the first assessment of Western Australia’s rural and remote health professionals’ knowledge, attitudes and practices regarding the diabetic foot. It shows that without training, generalists’ levels of knowledge concerning the diabetic foot was low and they were unlikely to assess foot risk. The findings from this study in a rural and remote setting cast doubt on the ability of generalist healthcare professionals to stratify risk appropriately, especially for those at intermediate risk, without clinical decision support tools.Electronic supplementary materialThe online version of this article (doi:10.1186/s13047-016-0157-2) contains supplementary material, which is available to authorized users.

The development and evaluation of an online intervention, ‘MePlusMe’, supporting mood, wellbeing, study skills, and everyday functioning in students in higher education

The development and evaluation of an online intervention, ‘MePlusMe’, supporting mood, wellbeing, study skills, and everyday functioning in students in higher education

Facilitated Reflective Performance Feedback: Developing an Evidence- and Theory-Based Model That Builds Relationship, Explores Reactions and Content, and Coaches for Performance Change (R2C2).

To develop and conduct feasibility testing of an evidence-based and theory-informed model for facilitating performance feedback for physicians so as to enhance their acceptance and use of the feedback. To develop the feedback model (2011-2013), the authors drew on earlier research which highlights not only the factors that influence giving, receiving, accepting, and using feedback but also the theoretical perspectives which enable the understanding of these influences. The authors undertook an iterative, multistage, qualitative study guided by two recognized research frameworks: the UK Medical Research Council guidelines for studying complex interventions and realist evaluation. Using these frameworks, they conducted the research in four stages: (1) modeling, (2) facilitator preparation, (3) model feasibility testing, and (4) model refinement. They analyzed data, using content and thematic analysis, and used the findings from each stage to inform the subsequent stage. Findings support the facilitated feedback model, its four phases-build relationship, explore reactions, explore content, coach for performance change (R2C2)-and the theoretical perspectives informing them. The findings contribute to understanding elements that enhance recipients' engagement with, acceptance of, and productive use of feedback. Facilitators reported that the model made sense and the phases generally flowed logically. Recipients reported that the feedback process was helpful and that they appreciated the reflection stimulated by the model and the coaching. The theory- and evidence-based reflective R2C2 Facilitated Feedback Model appears stable and helpful for physicians in facilitating their reflection on and use of formal performance assessment feedback.

An exploration of adolescents' decisions to abstain or refrain from alcohol consumption in Australian social settings: a qualitative systematic review.

A significant number of Australian adolescents consume alcohol, with almost two thirds of them doing so at risky levels. This is continuing to increase despite recent National Health and Medical Research Council (NHMRC) guidelines stipulating that no alcohol is the safest option. Measures initiated to reduce and prevent alcohol consumption by adolescents have limited effectiveness. Consumption of alcohol by Australian adolescents is a national concern because of the deleterious effects of alcohol consumption on adolescents' social, physical and neurological development, as well as other short- and long-term health risks, and the negative impact of alcohol-related violence and injury on the community. Understanding adolescents' decisions to abstain or refrain from alcohol consumption may provide valuable insights to assist in dealing with this significant social and health issue, more particularly about the mechanisms used by adolescents or their ability to make decisions about resisting or abstaining from alcohol consumption when exposed to alcohol in their social setting(s). The review aimed to synthesize the best available qualitative evidence on the decisions made or mechanisms used by adolescents who abstain or refrain from consuming alcohol in any social setting where alcohol is available. Adolescents aged between 14 and 19 years who reside in Australia.The phenomenon of interest was abstinence from or resistance to alcohol consumption when exposed to alcohol in social situations.This review considered studies that focused on qualitative data, including, but not limited to,designs such as phenomenology, grounded theory, action research and exploratory studies. A three-step search strategy was used. An initial search to identify keywords only was undertaken in Medline and CINAHL. This was followed by an expanded search using all identified keywords and index terms specific to each included database. The reference lists of included papers were then searched for any other relevant studies. No studies met the inclusion criteria sufficiently to progress to critical appraisal. No studies progressed to data extraction. Data synthesis was not undertaken as no study met the inclusion criteria. Although a number of studies retrieved indicated they had qualitative elements to their studies, the qualitative data was not reported. Although a number of studies met some aspects of the inclusion criteria there was insufficient reporting of the phenomenon of interest. Due to the lack of studies meeting the inclusion criteria, no conclusions can be drawn for clinical practice. A lack of qualitative data on this topic has been identified. Thus there is a great need for qualitative research to understand and know more about what enables an adolescent to abstain or refrain from consumption in order to inform or formulate effective interventions, policies or plans to prevent or reduce the volume of alcohol consumed by Australian adolescents.

Developing a theoretical maintenance model for disordered eating in Type 1 diabetes.

According to the literature, eating disorders are an increasing problem for more than a quarter of people with Type 1 diabetes and they are associated with accentuated diabetic complications. The clinical outcomes in this group when given standard eating disorder treatments are disappointing. The Medical Research Council guidelines for developing complex interventions suggest that the first step is to develop a theoretical model. To review existing literature to build a theoretical maintenance model for disordered eating in people with Type 1 diabetes. The literature in diabetes relating to models of eating disorder (Fairburn's transdiagnostic model and the dual pathway model) and food addiction was examined and assimilated. The elements common to all eating disorder models include weight/shape concern and problems with mood regulation. The predisposing traits of perfectionism, low self-esteem and low body esteem and the interpersonal difficulties from the transdiagnostic model are also relevant to diabetes. The differences include the use of insulin mismanagement to compensate for breaking eating rules and the consequential wide variations in plasma glucose that may predispose to 'food addiction'. Eating disorder symptoms elicit emotionally driven reactions and behaviours from others close to the individual affected and these are accentuated in the context of diabetes. The next stage is to test the assumptions within the maintenance model with experimental medicine studies to facilitate the development of new technologies aimed at increasing inhibitory processes and moderating environmental triggers.

Trial Steering Committees in randomised controlled trials: A survey of registered clinical trials units to establish current practice and experiences.

The Medical Research Council Guidelines for Good Clinical Practice outlines a three-committee trial oversight structure--the day-to-day Trial Management Group, the Data Monitoring Committee and the Trial Steering Committee. In this model, the Trial Steering Committee is the executive committee that oversees the trial and considers the recommendations from the Data Monitoring Committee. There is yet to be in-depth consideration establishing the Trial Steering Committee's role and functionality. A survey to establish Trial Steering Committee's current practices, role and the use and opinion on the Medical Research Council guidelines was undertaken within UK Clinical Research Collaborative registered Clinical Trials Units. Completed surveys were obtained from 38 of 47 fully and partially registered Units. Individual items in the survey were analysed and reported spanning current Trial Steering Committee practices including its role, requirement and experience required for membership; methods to identify members; and meeting frequency. Terms (a document describing the committee's remit, objectives and functionality) were obtained and analysed from 21 of 33 Units with documents in place at their Unit. A total of 20 responders suggested aspects of the current Medical Research Council Guidelines that need improvement. We present the first survey reporting on practices within UK Clinical Research Collaborative registered Clinical Trials Units on the experience and remits of Trial Steering Committees. We have identified a widespread adoption of Medical Research Council Guidelines for Trial Steering Committees in the United Kingdom, but limitations in this existing provision have been identified that need to be addressed.