Design and Development of a Film-based Intervention about Teenage Men and Unintended Pregnancy: Applying the Medical Research Council Framework in Practice

Following the UK Medical Research Council’s (MRC) guidelines for the development and evaluation of complex interventions, this study aimed to design, develop and optimise an educational intervention about young men and unintended teenage pregnancy based around an interactive film. The process involved identification of the relevant evidence base, development of a theoretical understanding of the phenomenon of unintended teenage pregnancy in relation to young men, and exploratory mixed methods research. The result was an evidence-based, theory-informed, user-endorsed intervention designed to meet the much neglected pregnancy education needs of teenage men and intended to increase both boys’ and girls’ intentions to avoid an unplanned pregnancy during adolescence. In prioritising the development phase, this paper addresses a gap in the literature on the processes of research-informed intervention design. It illustrates the application of the MRC guidelines in practice while offering a critique and additional guidance to programme developers on the MRC prescribed processes of developing interventions. Key lessons learned were: 1) know and engage the target population and engage gatekeepers in addressing contextual complexities; 2) know the targeted behaviours and model a process of change; and 3) look beyond development to evaluation and implementation.

Scientific standards for human intervention trials evaluating health benefits of foods, and their application to infants, children and adolescents

Associations between the consumption of particular foods and health outcomes may be indicated by observational studies. However, intervention trials that evaluate the health benefits of foods provide the strongest evidence to support dietary recommendations for health. Thus, it is important that these trials are carried out safely, and to high scientific standards. Accepted standards for the reporting of the health benefits of pharmaceutical and other medical interventions have been provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. However, there are no generally accepted standards for trials to evaluate the health benefits of foods. Trials with foods differ from medical trials in issues related to safety, ethics, research governance and practical implementation. Furthermore, these important issues can deter the conduct of both medical and nutrition trials in infants, children and adolescents. This paper provides standards for the planning, design, conduct, statistical analysis and interpretation of human intervention trials to evaluate the health benefits of foods that are based on the CONSORT guidelines, and outlines the key issues that need to be addressed in trials in participants in the paediatric age range.

Utilising a computer game as a therapeutic intervention for youth in residential care: Some preliminary findings on use and acceptability

Mental illness is common amongst young people living in residential care, many of whom are reluctant to avail of therapeutic help. The potential value of computer games as therapeutic tools for these young people has received very little attention, despite indications of their potential for promoting engagement in therapeutic work and improving mental health outcomes. This study aimed to fill this research gap through the development, introduction, and preliminary evaluation of a therapeutic intervention in group care settings. The intervention incorporated a commercially available computer game (The SIMS Life Stories™) and emotion regulation skill coaching. Qualified residential social workers were trained to deliver it to young people in three children's homes in Northern Ireland, where therapeutic approaches to social work had been introduced. The research was framed as an exploratory case study which aimed to determine the acceptability and potential therapeutic value of this intervention. The evidence suggests that computer-game based interventions of this type may have value as therapeutic tools in group care settings and deserve further development and empirical investigation to determine their effectiveness in improving mental health outcomes.

Falls prevention and support:: translating research, integrating services and promoting the contribution of service users for quality and innovative programmes of care

Falls are a significant threat to the safety, health and independence of older citizens. Despite the substantial evidence that is available around effective falls prevention programmes and interventions, their translation into falls reduction programmes and policies has yet to be fully realised. While hip fracture rates are decreasing, the number and incidence of fall-related hospital admissions among older people continue to rise. Given the demographic trends that highlight increasing numbers of older people in the UK, which is broadly reflected internationally, there is a financial and social imperative to minimise the rate of falls and associated injuries. Falling is closely aligned to growing older (Slips, Trips and Falls Update: From Acute and Community Hospitals and Mental Health Units in England and Wales, Department of Health, HMSO, London, 2010). According to the World Health Organization, around 30% of older people aged over 65 and 50% of those over 80 will fall each year (Falls Fact Sheet Number 344, WHO, Geneva, 2010). Falls happen as a result of many reasons and can have harmful consequences, including loss of mobility and independence, confidence and in many cases even death (Cochrane Database Syst Rev 15, 2009, 146; Slips, Trips and Falls Update: From Acute and Community Hospitals and Mental Health Units in England and Wales, Department of Health, HMSO, London, 2010; Falling Standards, Broken Promises: Report of the National
Audit of Falls and Bone Health in Older People 2010, Health Care Quality
Improvement Partnership, London, 2011). What is neither fair nor correct is the
common belief by old and young alike that falls are just another inconvenience to put up with. The available evidence justifiably supports the view that well-organised services, based upon national standards and expert guidance, can prevent future falls among older people and reduce death and disability from fractures. This paper will draw from the UK, as an exemplar for policy and practice, to discuss the strategic direction of falls prevention programmes for older people and the partnerships that need to exist between researchers, service providers and users of services to translate evidence to the clinical setting. Second, it will propose some mechanisms for disseminating evidence to healthcare professionals and other stakeholders, to improve the quality and capacity of the clinical workforce.

Minimal intervention dentistry and older patients part 2: minimally invasive operative interventions

As described in the first paper of this two part series, the expansion of our older population and the concomitant reduction in levels of edentulism will result in an increase in the number of patients presenting in general practice with complex restorative challenges. The application of the concepts of minimal intervention dentistry and minimally invasive operative techniques may offer a powerful armamentarium to the general dentist to provide ethical and conservative treatment to older patients.

Clinical Relevance: When it is unavoidable, operative intervention should be as minimally invasive as practicable in older patients to preserve the longevity of their natural dentition.

Minimal intervention dentistry and older patients Part 1: Risk assessment and caries prevention

Ten million people in the UK today are aged over 65. The latest projections estimate that there will be 5 1/2 million more people aged 65 and older in the next 20 years. This projected pattern of population ageing will have profound consequences for dentistry. Minimal intervention dentistry (MID) is a modern evidence-based approach to caries management in dentate patients that uses the 'medical model' whereby disease is controlled by the 'oral physician'. This approach offers considerable benefits over conventional dentistry for older patients. It encourages patients to be responsible for their oral health through the provision of both knowledge and motivation. MID encompasses risk assessment for dental disease, early detection and control of disease processes, and minimally invasive treatment. 

Clinical Relevance: Risk assessment tools can aid the general dental practitioner and the patient to develop a suitable caries prevention programme for that individual and reduce the need for future operative intervention.

A review of behaviour change theories and techniques used in group based self-management programmes for chronic low back pain and arthritis

Background: Medical Research Council (MRC) guidelines recommend applying theory within complex interventions to explain how behaviour change occurs. Guidelines endorse self-management of chronic low back pain (CLBP) and osteoarthritis (OA), but evidence for its effectiveness is weak. Objective: This literature review aimed to determine the use of behaviour change theory and techniques within randomised controlled trials of group-based self-management programmes for chronic musculoskeletal pain, specifically CLBP and OA. Methods: A two-phase search strategy of electronic databases was used to identify systematic reviews and studies relevant to this area. Articles were coded for their use of behaviour change theory, and the number of behaviour change techniques (BCTs) was identified using a 93-item taxonomy, Taxonomy (v1). Results: 25 articles of 22 studies met the inclusion criteria, of which only three reported having based their intervention on theory, and all used Social Cognitive Theory. A total of 33 BCTs were coded across all articles with the most commonly identified techniques being '. instruction on how to perform the behaviour', '. demonstration of the behaviour', '. behavioural practice', '. credible source', '. graded tasks' and '. body changes'. Conclusion: Results demonstrate that theoretically driven research within group based self-management programmes for chronic musculoskeletal pain is lacking, or is poorly reported. Future research that follows recommended guidelines regarding the use of theory in study design and reporting is warranted.

Holocene landscape intervention and plant food production strategies in island and mainland Southeast Asia

In the areas adjacent to the drowned Pleistocene continent of Sunda – present-day Mainland and Island SE Asia – the Austronesian Hypothesis of a diaspora of rice cultivators from Taiwan ∼4200 years ago has often been linked with the start of farming. Mounting evidence suggests that these developments should not be conflated and that alternative explanations should be considered, including indigenous inception of complex patterns of plant food production and early exchange of plants, animals, technology and genes. We review evidence for widespread forest disturbance in the Early Holocene which may accompany the beginnings of complex food-production. Although often insubstantial, evidence for incipient and developing management of rainforest vegetation and of developing complex relationships with plants is present, and early enough to suggest that during the Early to mid-Holocene this vast region was marked by different approaches to plant food production. The trajectory of the increasingly complex relationships between people and their food organisms was strongly locally contingent and in many cases did not result in the development of agricultural systems that were recognisable as such at the time of early European encounters. Diverse resource management economies in the Sunda and neighbouring regions appear to have accompanied rather than replaced a reliance on hunting and gathering. This, together with evidence for Early Holocene interaction between these neighbours, gives cause for us to question some authors continued adherence to a singular narrative of the Austronesian Hypothesis and the ‘Neolithisation’ of this part of the world. It also leads us to suggest that the forests of this vast region are, to an extent, a cultural artefact.

SWAT-1: The effectiveness of a 'site visit' intervention on recruitment rates in a multi-centre randomised trial

Background: Recruitment rates in multi-centre randomised trials often fall below target recruitment rates, causing problems for study outcomes. The Studies Within A Trial (SWAT) Programme, established by the All-Ireland Hub for Trials Methodology Research in collaboration with the Medical Research Council Network of Hubs in the United Kingdom and others, is developing methods for evaluating aspects of trial methodology through the conduct of research within research. A recently published design for a SWAT-1 provides a protocol for evaluating the effect of a site visit by the principal investigator on recruitment in multi-centre trials.

Methods: Using the SWAT-1 design, the effect of a site visit, with the sole purpose of discussing trial recruitment, on recruitment rates in a large multicentre trial in the Republic of Ireland was evaluated. A controlled before and after intervention comparison was used, where the date of the site visit provides the time point for the intervention, and for the comparison to control sites. Site A received the intervention. Site B and Site C acted as the controls. Z-scores for proportions were calculated to determine within site recruitment differences. Odds ratios and 95% confidence intervals were calculated to determine between site recruitment differences.

Results: Recruitment rates were increased in Site A post-intervention (17% and 14% percentage point increases at 1 and 3 months, respectively). No differences in recruitment occurred in Site B or in Site C. Comparing between site differences, at 3 months post-intervention, a statistically significant difference was detected in favour of higher recruitment in Site A (34% versus 25%; odds ratio 1.57, 95% confidence interval 1.09 to 2.26).

Conclusions: This is the first reported example of a study in the SWAT programme.. It provides evidence that a site visit, combined with a scheduled meeting, increases recruitment in a clinical trial. Using this example, other researchers might be encouraged to consider conducting a similar study, allowing the findings of future SWAT-1s to be compared and combined, so that higher level evidence on the effect of a site visit by the principal investigator can be obtained.

An evaluation of a tiered interrelated intervention to address hazardous/ harmful drinking

In Northern Ireland, alcohol misuse impacts negatively on individual drinkers, families and communities. The ‘Alcohol and You Project’ in the South Eastern Health and Social Care Trust is a funded project providing a range of inter-related services with the Trust and alcohol/drug misuse charities. It includes a self-help interactive website, brief intervention drop in clinics and counseling services. Queen's University Belfast is evaluating the effectiveness of the project to reduce hazardous/ harmful drinking.

Early intervention can improve outcomes in acute kidney injury

Acute Kidney Injury(AKI) is common, costly to manage and associated with high mortality. AKI can occur either in the community or in hospitalised patients and may be challenging to recognise because it is typically asymptomatic.Opportunities for prevention of AKI are frequently missed and in the absence of symptoms or signs there is often a delay in recognition ofestablished AKI.Approximately two thirds of hospitalised patients admitted with AKI have developed AKI in the community. AKI in hospitalised patients is associated with a substantial mortality rate > 20%. AKI is a potentially reversible process so improvements in recognition and early interventions could have a major impact on patient outcomes.

Developing the clinical components of a complex intervention for a glaucoma screening trial:a mixed methods study

BACKGROUND: Glaucoma is a leading cause of avoidable blindness worldwide. Open angle glaucoma is the most common type of glaucoma. No randomised controlled trials have been conducted evaluating the effectiveness of glaucoma screening for reducing sight loss. It is unclear what the most appropriate intervention to be evaluated in any glaucoma screening trial would be. The purpose of this study was to develop the clinical components of an intervention for evaluation in a glaucoma (open angle) screening trial that would be feasible and acceptable in a UK eye-care service.

METHODS: A mixed-methods study, based on the Medical Research Council (MRC) framework for complex interventions, integrating qualitative (semi-structured interviews with 46 UK eye-care providers, policy makers and health service commissioners), and quantitative (economic modelling) methods. Interview data were synthesised and used to revise the screening interventions compared within an existing economic model.

RESULTS: The qualitative data indicated broad based support for a glaucoma screening trial to take place in primary care, using ophthalmic trained technical assistants supported by optometry input. The precise location should be tailored to local circumstances. There was variability in opinion around the choice of screening test and target population. Integrating the interview findings with cost-effectiveness criteria reduced 189 potential components to a two test intervention including either optic nerve photography or screening mode perimetry (a measure of visual field sensitivity) with or without tonometry (a measure of intraocular pressure). It would be more cost-effective, and thus acceptable in a policy context, to target screening for open angle glaucoma to those at highest risk but for both practicality and equity arguments the optimal strategy was screening a general population cohort beginning at age forty.

CONCLUSIONS: Interventions for screening for open angle glaucoma that would be feasible from a service delivery perspective were identified. Integration within an economic modelling framework explicitly highlighted the trade-off between cost-effectiveness, feasibility and equity. This study exemplifies the MRC recommendation to integrate qualitative and quantitative methods in developing complex interventions. The next step in the development pathway should encompass the views of service users.

Development of a pharmacy practice intervention: lessons from the literature

The development of health interventions is receiving increasing attention within the scientific literature. In the past, interventions were often based on the ISLAGIATT principle: that is, ‘It seemed like a good idea at the time’. However, such interventions were frequently ineffective because they were either delivered in part or not at all, demonstrating a lack of fidelity, or because little attention had been paid to their development, content, and mode of delivery. This commentary seeks to highlight the latest methodological advances in the field of intervention development, drawing on health psychology literature, together with guidance from key organisations and research consortia which are setting standards for development and reporting. Those working within pharmacy practice research can learn from the more systematic approach being advocated, and apply these methods to help generate evidence to support new services and professional roles.

Defining the content and delivery of an intervention to Change AdhereNce to treatment in BonchiEctasis (CAN-BE): a qualitative approach incorporating the Theoretical Domains Framework, behavioural change techniques and stakeholder expert panels

Background
Low patient adherence to treatment is associated with poorer health outcomes in bronchiectasis. We sought to use the Theoretical Domains Framework (TDF) (a framework derived from 33 psychological theories) and behavioural change techniques (BCTs) to define the content of an intervention to change patients’ adherence in bronchiectasis (Stage 1 and 2) and stakeholder expert panels to define its delivery (Stage 3).

Methods
We conducted semi-structured interviews with patients with bronchiectasis about barriers and motivators to adherence to treatment and focus groups or interviews with bronchiectasis healthcare professionals (HCPs) about their ability to change patients’ adherence to treatment. We coded these data to the 12 domain TDF to identify relevant domains for patients and HCPs (Stage 1). Three researchers independently mapped relevant domains for patients and HCPs to a list of 35 BCTs to identify two lists (patient and HCP) of potential BCTs for inclusion (Stage 2). We presented these lists to three expert panels (two with patients and one with HCPs/academics from across the UK). We asked panels who the intervention should target, who should deliver it, at what intensity, in what format and setting, and using which outcome measures (Stage 3).

Results
Eight TDF domains were perceived to influence patients’ and HCPs’ behaviours: Knowledge, Skills, Beliefs about capability, Beliefs about consequences, Motivation, Social influences, Behavioural regulation and Nature of behaviours (Stage 1). Twelve BCTs common to patients and HCPs were included in the intervention: Monitoring, Self-monitoring, Feedback, Action planning, Problem solving, Persuasive communication, Goal/target specified:behaviour/outcome, Information regarding behaviour/outcome, Role play, Social support and Cognitive restructuring (Stage 2). Participants thought that an individualised combination of these BCTs should be delivered to all patients, by a member of staff, over several one-to-one and/or group visits in secondary care. Efficacy should be measured using pulmonary exacerbations, hospital admissions and quality of life (Stage 3).

Conclusions
Twelve BCTs form the intervention content. An individualised selection from these 12 BCTs will be delivered to all patients over several face-to-face visits in secondary care. Future research should focus on developing physical materials to aid delivery of the intervention prior to feasibility and pilot testing. If effective, this intervention may improve adherence and health outcomes for those with bronchiectasis in the future.

A study protocol for a pilot randomised trial of a structured education programme for the self-management of type 2 diabetes for adults with intellectual disabilities

BACKGROUND: The need for structured education programmes for type 2 diabetes is a high priority for many governments around the world. One such national education programme in the United Kingdom is the DESMOND Programme, which has been shown to be robust and effective for patients in general. However, these programmes are not generally targeted to people with intellectual disabilities (ID), and robust evidence on their effects for this population is lacking. We have adapted the DESMOND Programme for people with ID and type 2 diabetes to produce an amended programme known as DESMOND-ID. This protocol is for a pilot trial to determine whether a large-scale randomised trial is feasible, to test if DESMOND-ID is more effective than usual care in adults with ID for self-management of their type 2 diabetes, in particular as a means to reduce glycated haemoglobin (Hb1Ac), improve psychological wellbeing and quality of life and promote a healthier lifestyle. This protocol describes the rationale, methods, proposed analysis plan and organisational and administrative details.

METHODS/DESIGN: This trial is a two arm, individually randomised, pilot trial for adults with ID and type 2 diabetes, and their family and/or paid carers. It compares the DESMOND-ID programme with usual care. Approximately 36 adults with mild to moderate ID will be recruited from three countries in the United Kingdom. Family and/or paid carers may also participate in the study. Participants will be randomly assigned to one of two conditions using a secure computerised system with robust allocation concealment. A range of data will be collected from the adults with ID (biomedical, psychosocial and self-management strategies) and from their carers. Focus groups with all the participants will assess the acceptability of the intervention and the trial.

DISCUSSION: The lack of appropriate structured education programmes and educational materials for this population leads to secondary health conditions and may lead to premature deaths. There are significant benefits to be gained globally, if structured education programmes are adapted and shown to be successful for people with ID and other cognitive impairments.

TRIAL REGISTRATION: Registered with International Standard Randomised Controlled Trial (identifier: ISRCTN93185560 ) on 10 November 2014.