The generation of consensus guidelines for carrying out process evaluations in rehabilitation research.

BACKGROUND: Although in recent years there has been a strong increase in published research on theories (e.g. realist evaluation, normalization process theory) driving and guiding process evaluations of complex interventions, there is limited guidance to help rehabilitation researchers design and carry out process evaluations. This can lead to the risk of process evaluations being unsystematic. This paper reports on the development of new consensus guidelines that address the specific challenges of conducting process evaluations alongside clinical trials of rehabilitation interventions. METHODS: A formal consensus process was carried out based on a modified nominal group technique, which comprised two phases. Phase I was informed by the findings of a systematic review, and included a nominal group meeting with an expert panel of participants to rate and discuss the proposed statements. Phase II was an in depth semi-structured telephone interviews with expert panel participants in order to further discuss the structure and contents of the revised guidelines. Frequency of rating responses to each statement was calculated and thematic analysis was carried out on all qualitative data. RESULTS: The guidelines for carrying out process evaluations within complex intervention rehabilitation research were produced by combining findings from Phase I and Phase II. The consensus guidelines include recommendations that are grouped in seven sections. These sections are theoretical work, design and methods, context, recruitment and retention, intervention staff, delivery of the intervention and results. These sections represent different aspects or stages of the evaluation process. CONCLUSION: The consensus guidelines here presented can play a role at assisting rehabilitation researchers at the time of designing and conducting process evaluations alongside trials of complex interventions. The guidelines break new ground in terms of concepts and theory and works towards a consensus in regards to how rehabilitation researchers should go about carrying out process evaluations and how this evaluation should be linked into the proposed trials. These guidelines may be used, adapted and tested by rehabilitation researchers depending on the research stage or study design (e.g. feasibility trial, pilot trial, etc.).

Implementation and trial evidence: a plea for fore-thought.

In a world where evidence-based practice is see as the foundation of modern healthcare, this paper asks when and how should we be accounting for the input of patients, the public, dental professionals, commissioners and policy-makers in the evidence generation process?

Improving skills and care standards in the support workforce for older people: a realist synthesis of workforce development interventions.

OBJECTIVES: This evidence review was conducted to understand how and why workforce development interventions can improve the skills and care standards of support workers in older people's services. DESIGN: Following recognised realist synthesis principles, the review was completed by (1) development of an initial programme theory; (2) retrieval, review and synthesis of evidence relating to interventions designed to develop the support workforce; (3) 'testing out' the synthesis findings to refine the programme theories, and establish their practical relevance/potential for implementation through stakeholder interviews; and (4) forming actionable recommendations. PARTICIPANTS: Stakeholders who represented services, commissioners and older people were involved in workshops in an advisory capacity, and 10 participants were interviewed during the theory refinement process. RESULTS: Eight context-mechanism-outcome (CMO) configurations were identified which cumulatively comprise a new programme theory about 'what works' to support workforce development in older people's services. The CMOs indicate that the design and delivery of workforce development includes how to make it real to the work of those delivering support to older people; the individual support worker's personal starting points and expectations of the role; how to tap into support workers' motivations; the use of incentivisation; joining things up around workforce development; getting the right mix of people engaged in the design and delivery of workforce development programmes/interventions; taking a planned approach to workforce development, and the ways in which components of interventions reinforce one another, increasing the potential for impacts to embed and spread across organisations. CONCLUSIONS: It is important to take a tailored approach to the design and delivery of workforce development that is mindful of the needs of older people, support workers, health and social care services and the employing organisations within which workforce development operates. Workforce development interventions need to balance the technical, professional and emotional aspects of care. TRIAL REGISTRATION NUMBER: CRD42013006283.

Intervention Now To Eliminate Repeat Unintended Pregnancy in Teenagers (INTERUPT): a systematic review of intervention effectiveness and cost-effectiveness, qualitative and realist synthesis of implementation factors and user engagement.

BACKGROUND: The UK has the highest rate of teenage pregnancies in Western Europe, a fifth are repeat pregnancies. Unintended conceptions can result in emotional, psychological and educational harm to teenage girls, often with enduring implications for their life chances. Babies of teenage mothers have increased mortality in their first year and increased risk of poverty, educational underachievement and unemployment later in life, with associated societal costs. METHODS AND ANALYSIS: We will conduct a streamed, mixed-methods systematic review to find and evaluate interventions designed to reduce repeat unintended teen pregnancies. OUR AIMS ARE TO IDENTIFY:  Who is at greater risk of repeat unintended pregnancies? Which interventions are effective, cost-effective, how they work, in what setting and for whom? What are the barriers and facilitators to intervention uptake? Traditional electronic database searches will be augmented by targeted searches for evidence 'clusters' and guided by an advisory group of experts and stakeholders. To address the topic's inherent complexities, we will use a highly structured, innovative and iterative approach combining methodological techniques tailored to each stream of evidence. Quantitative data will be synthesised with reference to Cochrane guidelines for public health interventions. Qualitative evidence addressing facilitators and barriers to the uptake of interventions, experience and acceptability of interventions will be synthesised thematically. We will apply the principles of realist synthesis to uncover theories and mechanisms underpinning interventions. We will conduct an integration and overarching narrative of findings authenticated by client group feedback. ETHICS AND DISSEMINATION: We will publish the complete review in 'Health Technology Assessment' and sections in specialist peer-reviewed journals. We will present at national and international conferences in the fields of public health, reproductive medicine and review methodology. Findings will be fed back to service users and practitioners via workshops run by the partner collaborators. TRAIL REGISTRATION NUMBER: PROSPERO CRD42012003168. COCHRANE REGISTRATION NUMBER: i=fertility/0068.

Yoga for reducing perceived stress and back pain at work.

BACKGROUND: Stress and back pain are two key factors leading to sickness absence at work. Recent research indicates that yoga can be effective for reducing perceived stress, alleviating back pain, and improving psychological well-being. AIMS: To determine the effectiveness of a yoga-based intervention for reducing perceived stress and back pain at work. METHODS: Participants were recruited from a British local government authority and randomized into a yoga group who received one 50 min Dru Yoga session each week for 8 weeks and a 20 min DVD for home practice and a control group who received no intervention. Baseline and end-programme measurements of self-reported stress, back pain and psychological well-being were assessed with the Perceived Stress Scale, Roland Morris Disability Questionnaire and the Positive and Negative Affect Scale. RESULTS: There were 37 participants in each group. Analysis of variance and multiple linear regression showed that in comparison to the control group, the yoga group reported significant reductions in perceived stress and back pain, and a substantial improvement in psychological well-being. When compared with the control group at the end of the programme, the yoga group scores were significantly lower for perceived stress, back pain, sadness and hostility, and substantially higher for feeling self-assured, attentive and serene. CONCLUSIONS: The results indicate that a workplace yoga intervention can reduce perceived stress and back pain and improve psychological well-being. Larger randomized controlled trials are needed to determine the broader efficacy of yoga for improving workplace productivity and reducing sickness absence.

Research governance and ethics: a resource for novice researchers.

This article provides an overview of the research governance framework and ethical review. Issues surrounding new procedures are clarified and practical advice is provided for those embarking on research projects. The article discusses limitations and highlights possible future changes to research governance in the United Kingdom.

Ingredients for change: revisiting a conceptual framework.

Finding ways to deliver care based on the best possible evidence remains an ongoing challenge. Further theoretical developments of a conceptual framework are presented which influence the uptake of evidence into practice. A concept analysis has been conducted on the key elements of the framework--evidence, context, and facilitation--leading to refinement of the framework. While these three essential elements remain key to the process of implementation, changes have been made to their constituent sub-elements, enabling the detail of the framework to be revised. The concept analysis has shown that the relationship between the elements and sub-elements and their relative importance need to be better understood when implementing evidence based practice. Increased understanding of these relationships would help staff to plan more effective change strategies. Anecdotal reports suggest that the framework has a good level of validity. It is planned to develop it into a practical tool to aid those involved in planning, implementing, and evaluating the impact of changes in health care.

Formal consensus: the development of a national clinical guideline.

BACKGROUND: There is currently a political enthusiasm for the development and use of clinical guidelines despite, paradoxically, there being relatively few healthcare issues that have a sound research evidence base. As decisions have to be made even where there is an undetermined evidence base and that limiting recommendations to where evidence exists may reduce the scope of guidelines, thus limiting their value to practitioners, guideline developers have to rely on various different sources of evidence and adapt their methods accordingly. This paper outlines a method for guideline development which incorporates a consensus process devised to tackle the challenges of a variable research evidence base for the development of a national clinical guideline on risk assessment and prevention of pressure ulcers. METHOD: To inform the recommendations of the guideline a formal consensus process based on a nominal group technique was used to incorporate three strands of evidence: research, clinical expertise, and patient experience. RESULTS: The recommendations for this guideline were derived directly from the statements agreed in the formal consensus process and from key evidence-based findings from the systematic reviews. The existing format of the statements that participants had rated allowed a straightforward revision to "active" recommendations, thus reducing further risk of subjectivity entering into the process. CONCLUSIONS: The method outlined proved to be a practical and systematic way of integrating a number of different evidence sources. The resultant guideline is a mixture of research based and consensus based recommendations. Given the lack of available guidance on how to mix research with expert opinion and patient experiences, the method used for the development of this guideline has been outlined so that other guideline developers may use, adapt, and test it further.

Consumerism in health care: the case of medication education.

BACKGROUND: The United Kingdom government's policy documents spanning the last decade clearly envisage the patient as a consumer of health care. In this context this paper discusses recent research findings related to the health-promotion practice of medication delivered by nurses in England in a variety of health care settings. Literature exploring consumerism in health care highlights a number of principles which were used to develop a framework to evaluate the data collected in this study. METHOD: Non-participant observation and audio-recordings of nurse-patient interactions about medications were collected in seven different contexts focusing on adults, older people, mental health and community nurse settings. Post-interaction interviews with nurse and patient participants were conducted to explore views on quality, satisfaction with, and intended outcomes of, the interactions. FINDINGS: Generally, the findings demonstrated that the espoused theory and practice reality regarding the carrying out of consumerist principles are incongruous. Interactions contained relatively simple information, were dominated and led by nurses and offered little opportunity for patient choice. Patients, however, expressed a satisfaction with minimal information and involvement. CONCLUSION: The findings are discussed with reference to a number of different contextual factors: acuity of illness, perceived balance of power, information gaps, patterns of contact and nurse-patient relationships, and patient-centred care.

Nurses' educational preparation for a medication education role: findings from a national survey.

Nurses have a potentially important contribution to make to educating patients about medications. This nursing role is likely to acquire increasing significance as the number of nurses independently prescribing medicines grows, in addition to those nurses occupying autonomous and extended roles that involve ongoing assessment and monitoring of patients' medicine-taking behaviour. As part of a study(1)commissioned to evaluate nurses' educational preparation for, and practice of, medication education, a national survey of nurse education institutions was undertaken. A postal questionnaire was distributed to identified individuals within 51 education institutions in England. Respondents were asked about a number of curriculum design and delivery factors related to subjects central to medication education: pharmacology, patient education and communication skills. Analysis highlighted a number of themes: the teaching of pharmacology is generally integrated within other curricular modules; respondents were dissatisfied with insufficient curricular time devoted to taught pharmacology; the importance of lecturers' ability to apply theory to practice; a lack of clarity concerning pharmacology learning outcomes applied to medication education; and respondents' perceptions that opportunities for integrating pharmacology knowledge, patient education and communication skills were available within practice settings. The significance and implications of the findings are discussed in the context of current educational policy.

Evaluating educational preparation for a health education role in practice: the case of medication education.

Current health care policy and practice contexts in the UK point to the importance of nurses' ability to make an effective contribution to educating patients about medication, as part of their role in health education and health promotion. Nurses' potential contribution to this important activity will inevitably be dependent on knowledge and skills acquired during preregistration and postregistration programmes of education. Against this backdrop, changes in pre and postregistration nurse education in the UK in the past decade highlight the importance and timeliness of evaluating the adequacy of educational preparation for a medication role. This paper reports on the findings from an evaluation of UK educational preparation for a medication education role in practice. A case study design was used to investigate current educational preparation at three education institutions. Multiple methods of data collection at each site involved focus group discussions with lecturers and practitioners, individual interviews with key personnel, nonparticipant observation of teaching sessions, postobservation interviews with students and curriculum analysis. Findings highlighted the importance of a number of dimensions of preparation for practice of such a role: the need for sufficient taught pharmacology; opportunities for application and integration of prerequisite knowledge and skills; the importance of practice-based learning; the need for an evidence-based curriculum, and the importance of clarifying outcomes and competencies required for a medication education role within pre and postregistration curricula. The paper concludes with a discussion and implications of the findings.

Nursing, medication education and the new policy agenda: the evidence base.

Current social and demographic trends, combined with 'the new policy agenda', highlight the importance of nurses' role in educating patients about medication. In the absence of previous research investigation, this study set out to explore nurses' current contribution to medication education and the clinical contextual factors that influence current practice. The evidence base for effective medication education was established from reviews of literature and focus groups with key informants. Nurses' practice was investigated using a case study approach in seven clinical areas representing adult, care of the older person, mental health and community nursing contexts. Methods used to collect data were: audio-recordings (n=37) and observation (n=48) of nurse-patient interactions about medication, post-interaction interviews with nurses (n=29), post-interaction interviews with patients (n=39), analysis of relevant written documentation and researcher observation and field notes. Data sources within each case were subjected to systematic content analysis in order to identify current practice and contextual influences within each case. Cross-case analysis was also employed in order to identify explanations for any differentiation in practice. Findings indicate that nurses' contribution to medication education is commonly limited to simple information giving about medicines, involving the name, purpose, colour, number of tablets and the time and frequency that medications should be administered. Nurses' practice in two of the seven clinical areas was characterised by interactions that more closely demonstrated features of what is known to constitute more comprehensive and effective medication education. Analysis of contextual influences within and between cases allowed explanations to be derived for the types of medication education interactions observed. These concerned: patient characteristics, perceived and expressed preferences of patients for information, characteristics of the nurse-patient relationship, lack of time and high workload, and the philosophy of care within the clinical area. In all clinical areas, nurses were not explicitly and judiciously using available evidence to inform their medication-related interactions. The paper concludes with discussion and implications of the findings.

Nursing and medication education.

AIM: This study set out to explore nurses' current contribution to medication education and the clinical contextual factors that influence current practice. METHOD: Nurses' practice was investigated using a case study approach. Methods used to collect data were: audio-recordings and observation of nurse-patient interactions about medication, post-interaction interviews with nurses and patients, analysis of relevant written documentation and researcher observation and field notes. RESULTS: Findings indicate that nurses' contribution to medication education is commonly limited to giving simple information about medicines, involving the name, purpose, colour, number of tablets and the time and frequency for their administration. CONCLUSION: Nurse-patient relationships, patterns of contact and philosophy of care were all identified as contributory factors to enabling the practice of medication education in clinical areas.

Developing clinical guidelines: issues and challenges.

Clinical guidelines are viewed as an important tool in the quest to promote evidence based practice. Consequently, there has been a proliferation in guideline development at a national and local level. This paper describes what clinical guidelines are and how they have been developed by a national organisation--the Royal College of Nursing (RCN). Drawing on the development of two tissue viability guidelines: The Management of Patients with Venous Leg Ulcers and Risk Assessment and Prevention of Pressure Ulcers, some challenges inherent in guideline development are outlined. Certain desirable attributes that a clinical guideline should exhibit in order for it to be utilisable and effective in practice are outlined as these provide a standard for guideline developers. In reality the practice of guideline development will depend upon the topic, the experience of the guideline group, the purpose of the guidelines and the evidence available. Our experience suggests that producing a clinically valid and utilisable guideline is a labour and resource intensive process. It is also time consuming. An alternative strategy to developing local guidelines from scratch would be to adapt an existing guideline to local circumstances. A stepwise process is presented in the paper to assist people with this process.

Equity and rationing in the NHS: past to present.

AIM: This paper explores the historical and political basis of equity and rationing in the British National Health Service (NHS). BACKGROUND: Rationing has always featured in the NHS as an implicit, rather than explicit process. Recent healthcare reforms have highlighted the inequity of healthcare provision in the UK and made the rationing debate more explicit. ORIGINS OF INFORMATION: Information is drawn from a variety of sources which include research studies, review articles and books, policy documents and personal experience of working in the NHS. KEY ISSUES: The search for efficiency in the new NHS is in conflict with the principle of equity and the most vulnerable groups in society are being denied access to healthcare. Decisions about rationing are currently made at a local rather than a national level resulting in variability of health service provision, an inconsistency which will continue with the development of primary care groups. CONCLUSIONS: Rationing of healthcare resources is thought to be inevitable as demands for healthcare increase in a funds-limited service. Rationing of resources is a political problem that requires some form of guidance from central government.