Gastrostomy versus nasogastric tube feeding for chemoradiation patients with head and neck cancer: the TUBE pilot RCT.

BACKGROUND: Approximately 9000 new cases of head and neck squamous cell cancers (HNSCCs) are treated by the NHS each year. Chemoradiation therapy (CRT) is a commonly used treatment for advanced HNSCC. Approximately 90% of patients undergoing CRT require nutritional support via gastrostomy or nasogastric tube feeding. Long-term dysphagia following CRT is a primary concern for patients. The effect of enteral feeding routes on swallowing function is not well understood, and the two feeding methods have, to date (at the time of writing), not been compared. The aim of this pilot randomised controlled trial (RCT) was to compare these two options. METHODS: This was a mixed-methods multicentre study to establish the feasibility of a RCT comparing oral feeding plus pre-treatment gastrostomy with oral feeding plus as-required nasogastric tube feeding in patients with HNSCC. Patients were recruited from four tertiary centres treating cancer and randomised to the two arms of the study (using a 1 : 1 ratio). The eligibility criteria were patients with advanced-staged HNSCC who were suitable for primary CRT with curative intent and who presented with no swallowing problems. MAIN OUTCOME MEASURES: The primary outcome was the willingness to be randomised. A qualitative process evaluation was conducted alongside an economic modelling exercise. The criteria for progression to a Phase III trial were based on a hypothesised recruitment rate of at least 50%, collection of outcome measures in at least 80% of those recruited and an economic value-of-information analysis for cost-effectiveness. RESULTS: Of the 75 patients approached about the trial, only 17 consented to be randomised [0.23, 95% confidence interval (CI) 0.13 to 0.32]. Among those who were randomised, the compliance rate was high (0.94, 95% CI 0.83 to 1.05). Retention rates were high at completion of treatment (0.94, 95% CI 0.83 to 1.05), at the 3-month follow-up (0.88, 95% CI 0.73 to 1.04) and at the 6-month follow-up (0.88, 95% CI 0.73 to 1.04). No serious adverse events were recorded in relation to the trial. The qualitative substudy identified several factors that had an impact on recruitment, many of which are amenable to change. These included organisational factors, changing cancer treatments and patient and clinician preferences. A key reason for the differential recruitment between sites was the degree to which the multidisciplinary team gave a consistent demonstration of equipoise at all patient interactions at which supplementary feeding was discussed. An exploratory economic model generated from published evidence and expert opinion suggests that, over the 6-month model time horizon, pre-treatment gastrostomy tube feeding is not a cost-effective option, although this should be interpreted with caution and we recommend that this should not form the basis for policy. The economic value-of-information analysis indicates that additional research to eliminate uncertainty around model parameters is highly likely to be cost-effective. STUDY LIMITATIONS: The recruitment issues identified for this cohort may not be applicable to other populations undergoing CRT. There remains substantial uncertainty in the economic evaluation. CONCLUSIONS: The trial did not meet one of the three criteria for progression, as the recruitment rate was lower than hypothesised. Once patients were recruited to the trial, compliance and retention in the trial were both high. The implementation of organisational and operational measures can increase the numbers recruited. The economic analysis suggests that further research in this area is likely to be cost-effective. FUTURE WORK: The implementation of organisational and operational measures can increase recruitment. The appropriate research question and design of a future study needs to be identified. More work is needed to understand the experiences of nasogastric tube feeding in patients undergoing CRT. TRIAL REGISTRATION: Current Controlled Trials ISRCTN48569216. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 16. See the NIHR Journals Library website for further project information.

Integrating Evidence From Systematic Reviews, Qualitative Research, and Expert Knowledge Using Co-Design Techniques to Develop a Web-Based Intervention for People in the Retirement Transition.

BACKGROUND: Integrating stakeholder involvement in complex health intervention design maximizes acceptability and potential effectiveness. However, there is little methodological guidance about how to integrate evidence systematically from various sources in this process. Scientific evidence derived from different approaches can be difficult to integrate and the problem is compounded when attempting to include diverse, subjective input from stakeholders. OBJECTIVE: The intent of the study was to describe and appraise a systematic, sequential approach to integrate scientific evidence, expert knowledge and experience, and stakeholder involvement in the co-design and development of a complex health intervention. The development of a Web-based lifestyle intervention for people in retirement is used as an example. METHODS: Evidence from three systematic reviews, qualitative research findings, and expert knowledge was compiled to produce evidence statements (stage 1). Face validity of these statements was assessed by key stakeholders in a co-design workshop resulting in a set of intervention principles (stage 2). These principles were assessed for face validity in a second workshop, resulting in core intervention concepts and hand-drawn prototypes (stage 3). The outputs from stages 1-3 were translated into a design brief and specification (stage 4), which guided the building of a functioning prototype, Web-based intervention (stage 5). This prototype was de-risked resulting in an optimized functioning prototype (stage 6), which was subject to iterative testing and optimization (stage 7), prior to formal pilot evaluation. RESULTS: The evidence statements (stage 1) highlighted the effectiveness of physical activity, dietary and social role interventions in retirement; the idiosyncratic nature of retirement and well-being; the value of using specific behavior change techniques including those derived from the Health Action Process Approach; and the need for signposting to local resources. The intervention principles (stage 2) included the need to facilitate self-reflection on available resources, personalization, and promotion of links between key lifestyle behaviors. The core concepts and hand-drawn prototypes (stage 3) had embedded in them the importance of time use and work exit planning, personalized goal setting, and acceptance of a Web-based intervention. The design brief detailed the features and modules required (stage 4), guiding the development of wireframes, module content and functionality, virtual mentors, and intervention branding (stage 5). Following an iterative process of intervention testing and optimization (stage 6), the final Web-based intervention prototype of LEAP (Living, Eating, Activity, and Planning in retirement) was produced (stage 7). The approach was resource intensive and required a multidisciplinary team. The design expert made an invaluable contribution throughout the process. CONCLUSIONS: Our sequential approach fills an important methodological gap in the literature, describing the stages and techniques useful in developing an evidence-based complex health intervention. The systematic and rigorous integration of scientific evidence, expert knowledge and experience, and stakeholder input has resulted in an intervention likely to be acceptable and feasible.

Pilot Randomised Controlled Trial of a Web-Based Intervention to Promote Healthy Eating, Physical Activity and Meaningful Social Connections Compared with Usual Care Control in People of Retirement Age Recruited from Workplaces.

BACKGROUND: Lifestyle interventions delivered during the retirement transition might promote healthier ageing. We report a pilot randomised controlled trial (RCT) of a web-based platform (Living, Eating, Activity and Planning through retirement; LEAP) promoting healthy eating (based on a Mediterranean diet (MD)), physical activity (PA) and meaningful social roles. METHODS: A single blinded, two-arm RCT with individual allocation. Seventy-five adult regular internet users living in Northeast England, within two years of retirement, were recruited via employers and randomised in a 2:1 ratio to receive LEAP or a 'usual care' control. Intervention arm participants were provided with a pedometer to encourage self-monitoring of PA goals. Feasibility of the trial design and procedures was established by estimating recruitment and retention rates, and of LEAP from usage data. At baseline and 8-week follow-up, adherence to a MD derived from three 24-hour dietary recalls and seven-day PA by accelerometry were assessed. Healthy ageing outcomes (including measures of physiological function, physical capability, cognition, psychological and social wellbeing) were assessed and acceptability established by compliance with measurement protocols and completion rates. Thematically analysed, semi-structured, qualitative interviews assessed acceptability of the intervention, trial design, procedures and outcome measures. RESULTS: Seventy participants completed the trial; 48 (96%) participants in the intervention and 22 (88%) in the control arm. Participants had considerable scope for improvement in diet as assessed by MD score. LEAP was visited a median of 11 times (range 1-80) for a mean total time of 2.5 hours (range 5.5 min- 8.3 hours). 'Moving more', 'eating well' and 'being social' were the most visited modules. At interview, participants reported that diet and PA modules were important and acceptable within the context of healthy ageing. Participants found both trial procedures and outcome assessments acceptable. CONCLUSIONS: The trial procedures and the LEAP intervention proved feasible and acceptable. Effectiveness and cost-effectiveness of LEAP to promote healthy lifestyles warrant evaluation in a definitive RCT. TRIAL REGISTRATION: ClinicalTrials.gov NCT02136381.

Mobilizing Resources for Well-being: Implications for Developing Interventions in the Retirement Transition.

PURPOSE OF THE STUDY: Good health and well-being in later life are central issues for public health. Retirement presents an opportunity to intervene to improve health and well-being, as individuals may adjust associated lifestyle behaviors. However, there is little evidence about how well-being is experienced in the context of increasingly diverse retirement transitions. Our objectives were to explore (a) views on health and well-being through retirement transitions and (b) acceptability of intervening in this period. DESIGN AND METHODS: Qualitative study involving 48 workers/retirees, aged 53-77 years of diverse socioeconomic status, were recruited from urban and rural areas in North East England. Data were collected iteratively through focus groups (n = 6), individual interviews (n = 13), interviews with couples (n = 4), using the constant comparative method. Analysis was informed by theories of the Third Age and Sen's capabilities approach. RESULTS: Diverse retirement transitions were shaped by unanticipated events. Central to well-being was the "capability" to utilize resources to achieve desirable outcomes. Participants rejected a "later life" identity, associating it with decline, and an uncertain future. IMPLICATIONS: Lifestyle interventions that address challenges within the retirement transition may be acceptable. Inducements to change behavior based on possible long-term outcomes may be less appealing. Providing assistance to use resources to address personal goals may be central to effective interventions.

Towards measurement of the Healthy Ageing Phenotype in lifestyle-based intervention studies.

INTRODUCTION: Given the biological complexity of the ageing process, there is no single, simple and reliable measure of how healthily someone is ageing. Intervention studies need a panel of measures which capture key features of healthy ageing. To help guide our research in this area, we have adopted the concept of the "Healthy Ageing Phenotype" (HAP) and this study aimed to (i) identify the most important features of the HAP and (ii) identify/develop tools for measurement of those features. METHODS: After a comprehensive assessment of the literature we selected the following domains: physiological and metabolic health, physical capability, cognitive function, social wellbeing, and psychological wellbeing which we hoped would provide a reasonably holistic characterisation of the HAP. We reviewed the literature and identified systematic reviews and/or meta-analysis of cohort studies, and clinical guidelines on outcome measures of these domains relevant to the HAP. Selection criteria for these measures included: frequent use in longitudinal studies of ageing; expected to change with age; evidence for strong association with/prediction of ageing-related phenotypes such as morbidity, mortality and lifespan; whenever possible, focus on studies measuring these outcomes in populations rather than on individuals selected on the basis of a particular disease; (bio)markers that respond to (lifestyle-based) intervention. Proposed markers were exposed to critique in a Workshop held in Newcastle, UK in October 2012. RESULTS: We have selected a tentative panel of (bio)markers of physiological and metabolic health, physical capability, cognitive function, social wellbeing, and psychological wellbeing which we propose may be useful in characterising the HAP and which may have utility as outcome measures in intervention studies. In addition, we have identified a number of tools which could be applied in community-based intervention studies designed to enhance healthy ageing. CONCLUSIONS: We have proposed, tentatively, a panel of outcome measures which could be deployed in community-based, lifestyle intervention studies. The evidence base for selection of measurement domains is less well developed in some areas e.g. social wellbeing (where the definition of the concept itself remains elusive) and this has implications for the identification of appropriate tools. Although we have developed this panel as potential outcomes for intervention studies, we recognise that broader agreement on the concept of the HAP and on tools for its measurement could have wider utility and e.g. could facilitate comparisons of healthy ageing across diverse study designs and populations.

Supporting well-being in retirement through meaningful social roles: systematic review of intervention studies.

CONTEXT: The marked demographic change toward greater proportions of older people in developed nations poses significant challenges for health and social care. Several studies have demonstrated an association between social roles in later life and positive health and well-being outcomes. After retiring from work, people may lose roles that provide purpose and social contacts. The outcomes of interventions to promote social roles in retirement have not been systematically reviewed. METHODS: We examined three research questions: (1) What kinds of intervention have been developed to promote social roles in retirement? (2) How much have they improved perceived roles? (3) Have these roles improved health or well-being? We included those studies that evaluated the provision of social roles; used a control or comparison group; targeted healthy retirement-transition adults who were living in the community; provided an abstract written in English; took place in a highly developed nation; and reported social role, health, or well-being outcomes. We searched eight electronic databases and combined the results with hand searches. FINDINGS: Through our searches, we identified 9,062 unique publications and eleven evaluative studies of acceptable quality, which reported seven interventions that met our inclusion criteria. These interventions varied in year of inception and scope, but only two were based outside North America. The studies rarely reported the quality or meaning of roles. Only three studies used random allocation, thus limiting inferences of causality from these studies. Interventions providing explicit roles and using supportive group structures were somewhat effective in improving one or more of the following: life satisfaction, social support and activity, physical health and activity, functional health, and cognition. CONCLUSIONS: Social role interventions may improve health and well-being for people in retirement transition. Future research should improve the quality of intervention and assessment and look at which interventions are most effective and acceptable in facilitating social roles for diverse older populations.

Food work and feeding assistance on hospital wards.

Approximately 60 per cent of UK patients aged 65 years or older are at risk of malnutrition or their situation worsening while in hospital. We report the results of a qualitative study embedded in research to prevent malnutrition in older people in hospital (the mappmal study). Our aim was to understand and describe processes that promote or inhibit nutrition in hospital. Throughout 2009 we examined meal services at four UK hospital sites across two regional locations, focusing on older patients admitted with dementia, for stroke or for fractured neck of femur. Data were collected through semi-structured interviews with National Health Service staff (n = 54), stakeholders (n = 6), and a focus group with former patients and carers (n = 5). We identified ward-based food work as a technical and interpersonal challenge in narratives around malnutrition. Food work constituted two overlapping spheres of activity: interpersonal engagement through feeding assistance and reassurance and the arrangement of resources that facilitate meals such as the preparation of food trolleys. Our analysis is framed by the literature on emotional labour, dirty work and the professionalisation of nursing. We demonstrate how food work is overlooked by being conceptualised as common sense and as one of the most mundane and elementary tasks in hospitals.

Implementing nutrition guidelines for older people in residential care homes: a qualitative study using Normalization Process Theory.

BACKGROUND: Optimizing the dietary intake of older people can prevent nutritional deficiencies and diet-related diseases, thereby improving quality of life. However, there is evidence that the nutritional intake of older people living in care homes is suboptimal, with high levels of saturated fat, salt, and added sugars. The UK Food Standards Agency therefore developed nutrient- and food-based guidance for residential care homes. The acceptability of these guidelines and their feasibility in practice is unknown. This study used the Normalization Process Theory (NPT) to understand the barriers and facilitators to implementing the guidelines and inform future implementation. METHODS: We conducted a process evaluation in five care homes in the north of England using qualitative methods (observation and interviews) to explore the views of managers, care staff, catering staff, and domestic staff. Data were analyzed thematically and discussed in data workshops; emerging themes were then mapped to the constructs of NPT. RESULTS: Many staff perceived the guidelines as unnecessarily restrictive and irrelevant to older people. In terms of NPT, the guidelines simply did not make sense (coherence), and as a result, relatively few staff invested in the guidelines (cognitive participation). Even where staff supported the guidelines, implementation was hampered by a lack of nutritional knowledge and institutional support (collective action). Finally, the absence of observable benefits to clients confirmed the negative preconceptions of many staff, with limited evidence of reappraisal following implementation (reflexive monitoring). CONCLUSIONS: The successful implementation of the nutrition guidelines requires that the fundamental issues relating to their perceived value and fit with other priorities and goals be addressed. Specialist support is needed to equip staff with the technical knowledge and skills required for menu analysis and development and to devise ways of evaluating the outcomes of modified menus. NPT proved useful in conceptualizing barriers to implementation; robust links with behavior-change theories would further increase the practical utility of NPT.

Extending an approach to hospital malnutrition to community care.

This feature investigates the potential relevance to community care of a new food provision and nutritional management system for older hospital patients. A qualitative study identified the core factors contributing to inadequate food intake in older patients in hospital, including: poor mealtime ambience; lack of necessary mealtime assistance; inflexible meal provision; lack of monitoring of nutrient intake and absence of accountability in nutritional care. Many of these factors are also relevant to older people living in the community. To address these issues, we designed a new system for the nutritional care of the older patient: 'hospitalfoodie'. Hospitalfoodie facilitates: patient nutritional screening; patient-tailored food choice; and information exchange among the healthcare team. The system introduces a more flexible approach to provision of food, including the development of nutrient-dense 'mini meals' for older patients. The system facilitates monitoring of patient food intake against their nutrition targets and alerts staff of nutrition shortfalls. The relevance of components of hospitalfoodie to community nutritional care was explored through qualitative interviews and focus groups with a range of care providers.

Understanding the implementation of complex interventions in health care: the normalization process model.

BACKGROUND: The Normalization Process Model is a theoretical model that assists in explaining the processes by which complex interventions become routinely embedded in health care practice. It offers a framework for process evaluation and also for comparative studies of complex interventions. It focuses on the factors that promote or inhibit the routine embedding of complex interventions in health care practice. METHODS: A formal theory structure is used to define the model, and its internal causal relations and mechanisms. The model is broken down to show that it is consistent and adequate in generating accurate description, systematic explanation, and the production of rational knowledge claims about the workability and integration of complex interventions. RESULTS: The model explains the normalization of complex interventions by reference to four factors demonstrated to promote or inhibit the operationalization and embedding of complex interventions (interactional workability, relational integration, skill-set workability, and contextual integration). CONCLUSION: The model is consistent and adequate. Repeated calls for theoretically sound process evaluations in randomized controlled trials of complex interventions, and policy-makers who call for a proper understanding of implementation processes, emphasize the value of conceptual tools like the Normalization Process Model.

Development of a series of patient information leaflets for constipation using a range of cognitive interview techniques: LIFELAX.

BACKGROUND: The aim of the LIFELAX randomised controlled trial (diet and lifestyle vs. laxatives in the management of chronic constipation) is to develop and evaluate a cost effective intervention to promote diet and lifestyle in the treatment and management of chronic constipation for older people in Primary Care. Constipation affects the quality of life in around 20% of older people in the community. In the 65 years plus population, a significant proportion of men and women both living in institutions (81% and 75% respectively) and free living (30% and 37% respectively) use laxatives. Approximately 42 million pounds is spent each year on prescribed laxatives in England in addition to laxatives purchased over the counter. Although bowel problems are often multifactorial, diet and lifestyle have an extremely important role in their management. This paper describes one aspect of the main study, the development and piloting of the Patient information leaflets (PILs). METHODS: Following review of the literature and interviews with practitioners and patients, 8 PILs were designed on: constipation, activity, bowel health, fruit and vegetables, fibre, fluid, alternative therapies and laxatives. To check the patient's understanding of terms used in the PILS and the clarity and accessibility of the information understanding, cognitive interviews (CI) were used with nine patients (selected from 3 GP surgeries), aged > or = 55 years, who had received > or = 3 prescriptions of laxatives over 12 months. Interviews were recorded and transcribed. RESULTS: Changes made following the CI process included the lay-out, words used (e.g. 'exercise' was changed to 'activity', 'gut motility' changed to 'bowel movement') and descriptions and examples were adapted to be more appropriate for the target population. CONCLUSION: Pilot testing with CIs resulted in improvements in the PILs, which emphasises the need to pilot PILs with the target population before use. The techniques employed are relatively inexpensive and could be routinely used when preparing literature for research or clinical use including those intended for use with healthcare professionals and patients.

Medical communication and technology: a video-based process study of the use of decision aids in primary care consultations.

BACKGROUND: Much of the research on decision-making in health care has focused on consultation outcomes. Less is known about the process by which clinicians and patients come to a treatment decision. This study aimed to quantitatively describe the behaviour shown by doctors and patients during primary care consultations when three types of decision aids were used to promote treatment decision-making in a randomised controlled trial. METHODS: A video-based study set in an efficacy trial which compared the use of paper-based guidelines (control) with two forms of computer-based decision aids (implicit and explicit versions of DARTS II). Treatment decision concerned warfarin anti-coagulation to reduce the risk of stroke in older patients with atrial fibrillation. Twenty nine consultations were video-recorded. A ten-minute 'slice' of the consultation was sampled for detailed content analysis using existing interaction analysis protocols for verbal behaviour and ethological techniques for non-verbal behaviour. RESULTS: Median consultation times (quartiles) differed significantly depending on the technology used. Paper-based guidelines took 21 (19-26) minutes to work through compared to 31 (16-41) minutes for the implicit tool; and 44 (39-55) minutes for the explicit tool. In the ten minutes immediately preceding the decision point, GPs dominated the conversation, accounting for 64% (58-66%) of all utterances and this trend was similar across all three arms of the trial. Information-giving was the most frequent activity for both GPs and patients, although GPs did this at twice the rate compared to patients and at higher rates in consultations involving computerised decision aids. GPs' language was highly technically focused and just 7% of their conversation was socio-emotional in content; this was half the socio-emotional content shown by patients (15%). However, frequent head nodding and a close mirroring in the direction of eye-gaze suggested that both parties were active participants in the conversation CONCLUSION: Irrespective of the arm of the trial, both patients' and GPs' behaviour showed that they were reciprocally engaged in these consultations. However, even in consultations aimed at promoting shared decision-making, GPs' were verbally dominant, and they worked primarily as information providers for patients. In addition, computer-based decision aids significantly prolonged the consultations, particularly the later phases. These data suggest that decision aids may not lead to more 'sharing' in treatment decision-making and that, in their current form, they may take too long to negotiate for use in routine primary care.

Technogovernance: evidence, subjectivity, and the clinical encounter in primary care medicine.

Technological solutions to problems of knowledge and practice in health care are routinely advocated. This paper explores the ways that new systems of practice are being deployed as intermediaries in interactions between clinicians and their patients. Central to this analysis is the apparent conflict between two important ways of organizing ideas about practice in primary care. First, a shift away from the medical objectification of the patient, towards patient-centred clinical practice in which patients'heterogeneous experiences and narratives of ill-health are qualitatively engaged and enrolled in decisions about the management of illness trajectories. Second the mobilization of evidence about large populations of experimental subjects revealed through an impetus towards evidence-based medicine, in which quantitative knowledge is engaged and enrolled to guide the management of illness, and is mediated through clinical guidelines. The tension between these two ways of organizing ideas about clinical practice is a strong one, but both impulses are embodied in new 'technological' solutions to the management of heterogeneity in the clinical encounter. Technological solutions themselves, we argue, embody and enact these tensions, but may also be opening up a new array of practices--technogovernance--in which the heterogeneous narratives of the patient-centred encounter can be resituated and guided.

Patients or research subjects? A qualitative study of participation in a randomised controlled trial of a complex intervention.

OBJECTIVE: To explore participants' understandings regarding treatment decisions, made within an efficacy randomised controlled trial (RCT) of decision-support tools. METHODS: Qualitative study: interviews (audio-recorded) with participants. Participants were interviewed 3-5 days after using a decision-support tool (n=30) and again at 3 months (n=26). Transcripts were analysed using a constant comparative approach. RESULTS: Participants' understandings were shaped by the ways in which they made sense of their participation. Participants made attributions about their trial identity that fell on a continuum. At one end we found participants who identified as 'experienced medical volunteers', and at the other those who identified as 'real patients'. In the participants' accounts, a trial identity of 'patient' accompanied an expectation that the decision-support tools offered a means of making treatment decisions. 'Volunteers', however, saw the interventions as tasks to be completed for the purposes of the trial team. CONCLUSION: In our study, trial identity shaped participants' understandings regarding treatment decisions and all other aspects of the trial. PRACTICE IMPLICATIONS: Different understandings regarding the appropriate response to trial tasks may affect behaviour and therefore outcomes in some trials. Further research is required to unravel the relationship between trial identities, understanding and behaviour.

Doctor-patient interaction in a randomised controlled trial of decision-support tools.

In this paper, we draw on the analytic perspectives of ethnomethodology to explore doctor-patient encounters in an experimental trial of a complex intervention: an efficacy randomised controlled trial (RCT) of decision-support tools in the UK. We show how the experimental context in which these encounters take place pervades the interactions within them. We argue that two interactional orders were at work in the encounters that we observed: (i) the ceremonial order of the consultation and (ii) the assemblage of the decision-support tool trial. We demonstrate how doctors in the trial oscillate between positions as authoritative clinician and neutralistic decision-support tool-implementer, and patients move between positions as passive recipients of clinical knowledge and as active subjects required to render their experience as calculable in terms of the demands of the decision-support tools and the broader trial they are embedded in. We demonstrate how the RCT coordinates the world of the clinical environment and the world of experimental evidence.