A pilot cluster randomised trial to assess the effect of a structured communication approach on quality of life in secure mental health settings: the Comquol study

Background There is a lack of research in forensic settings examining therapeutic relationships. A structured communication approach, placing patients’ perspectives at the heart of discussions about their care, was used to improve patients’ quality of life in secure settings. The objectives were to: • Establish the feasibility of the trial design • Determine the variability of the outcomes of interest • Estimate the costs of the intervention • If necessary, refine the intervention Methods A pilot cluster randomised controlled trial was conducted. Data was collected from July 2012 to January 2015 from participants in 6 medium secure in–patient services in London and Southern England. 55 patients and 47 nurses were in the intervention group with 57 patients and 45 nurses in the control group. The intervention comprised 6 nurse-patient meetings over a 6 month period. Patients rated their satisfaction with a range of domains followed by discussions on improving patient identified problems. Assessments took place at baseline, 6 months, and 12 months. Participants were not blind to their allocated group. The primary outcome was self-reported quality of life collected by a researcher blind to participants’ allocation status. Results The randomisation procedures and intervention approach functioned well. The measures used were understood by the participants and gave relevant outcome information. The response rates were good with low patient withdrawal rates. The quality of life estimated treatment effect was 0.2 (95% CI: -0.4 to 0.8) at 6 months and 0.4 (95% CI: -0.3 to 1.1) indicating the likely extreme boundaries of effect in the main trial. The estimated treatment effect of the primary outcome is clinically important, and a positive effect of the intervention is not ruled out. The estimate of the ICC for the primary outcome at 6 and 12 months was 0.04 (0.00 to 0.17) and 0.05 (0.00 to 0.18). The cost of the intervention was £529 per patient. Conclusions The trial design was viable as the basis for a full-scale trial. A full trial is justified to estimate the effect of the intervention with greater certainty. The variability of the outcomes could be used to calculate numbers needed for a full-scale trial. Ratings of need for therapeutic security may be useful in any future study

Implementation and delivery of group consultations for young people with diabetes in socioeconomically deprived, ethnically diverse settings

BACKGROUND: Young people with diabetes experience poor clinical and psychosocial outcomes, and consider the health service ill-equipped in meeting their needs. Improvements, including alternative consulting approaches, are required to improve care quality and patient engagement. We examined how group-based, outpatient diabetes consultations might be delivered to support young people (16-25 years old) in socio-economically deprived, ethnically diverse settings. METHODS: This multi-method, comparative study recruited a total of 135 young people with diabetes across two implementation and two comparison sites (2017-2019). Informed by a 'researcher-in-residence' approach and complexity theory, we used a combination of methods: (a) 31 qualitative interviews with young people and staff and ethnographic observation in group and individual clinics, (b) quantitative analysis of sociodemographic, clinical, service use, and patient enablement data, and (c) micro-costing analysis. RESULTS: Implementation sites delivered 29 group consultations in total. Overall mean attendance per session was low, but a core group of young people attended repeatedly. They reported feeling better understood and supported, gaining new learning from peers and clinicians, and being better prepared to normalise diabetes self-care. Yet, there were also instances where peer comparison proved difficult to manage. Group consultations challenged deeply embedded ways of thinking about care provision and required staff to work flexibly to achieve local tailoring, sustain continuity, and safely manage complex interdependencies with other care processes. Set-up and delivery were time-consuming and required in-depth clinical and relational knowledge of patients. Facilitation by an experienced youth worker was instrumental. There was indication that economic value could derive from preventing at least one unscheduled consultation annually. CONCLUSIONS: Group consulting can provide added value when tailored to meet local needs rather than following standardised approaches. This study illustrates the importance of adaptive capability and self-organisation when integrating new models of care, with young people as active partners in shaping service provision. TRIAL REGISTRATION: ISRCTN reference 27989430

Group clinics for young adults living with diabetes in an ethnically diverse, socioeconomically deprived population: mixed-methods evaluation

Background Our research was based on the expressed need to evaluate the potential for group clinics to enhance care within the NHS for people with long-term conditions. Objectives We aimed to explore the scope, feasibility, impact and potential scalability of group clinics for young adults with diabetes who have poor experiences of care and clinical outcomes. We applied a participatory approach to the entire research process, where appropriate. Setting Four NHS trusts delivering diabetes care to young adults in ethnically diverse and socioeconomically deprived communities. Participants We involved 135 young adults as participants in our research (73 at two intervention sites and 62 at two control sites). Methods A realist review synthesised existing evidence for group clinics to understand ‘what works, for whom, under what circumstances’. Using the realist review findings and a scoping exercise, we used co-design to develop a model of group clinic-based care, which we then implemented and evaluated using primarily qualitative methods, with quantitative and costs analyses to inform future evaluations. Results Young adults reported positive experiences from the group clinics. However, across the group clinics delivered, only one-third (on average) of those invited to specific clinics attended, despite substantial efforts to encourage attendance, and only 37 out of 73 (51%) participants attended any group clinics. Social learning helped the acquisition of new knowledge and normalisation of experiences. Group clinics met previously unreached emotional needs, and the relationships that formed between young adults, and between them and the staff facilitating the clinics, were key. Clinical staff delivered the clinics using a facilitatory approach, and a youth worker helped to ensure that the care model was developmentally appropriate. Existing organisational structures presented substantial challenges to the delivery of group clinics, and there was considerable hidden work required by the staff delivering them. Group clinics may augment one-to-one care but do not necessarily replace it. The average cost of each group clinic, per participant, was £127–58. Limitations Engagement in co-design and the research process and participation in the group clinics was challenging, and limited our quantitative data analysis. These limitations had implications for the fidelity of the intervention and generalisability of our findings. During the research, we established that group clinics would not replace existing care, and that further work is required to understand the theoretical base of ‘blended’ models of care, and the potential of digital offers, before a definitive evaluation (a cluster-randomised trial) can be designed. Conclusions Our findings show that young adults with diabetes, including those in deprived and ethnically diverse settings, have positive experiences of group-based care, and it may augment existing one-to-one care. However, engagement with group-based care is challenging despite the participatory design. Future work Future research is needed to develop the group clinic model prior to definitive evaluation. Study registration This study is registered as CRD42017058726 and ISRCTN83599025. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 25. See the NIHR Journals Library website for further project information

Cost-effectiveness of a national exercise referral programme for primary care patients in Wales: results of a randomised controlled trial

This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.The research was independent and funded by the Welsh Assembly Government. RTE is supported by Public Health Wales. Additional support for LM and SM during write up was provided by The Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), a UKCRC Public Health Research: Centre of Excellence. Funding from the British Heart Foundation, Cancer Research UK, Economic and Social Research Council (RES-590-28-0005), Medical Research Council, the Welsh Assembly Government and the Wellcome Trust (WT087640MA), under the auspices of the UK Clinical Research Collaboration, is gratefully acknowledged

'The mum has to live with the decision much more than the dad'; a qualitative study of men's perceptions of their influence on breastfeeding decision-making

© 2018 The Author(s). Background: Although breastfeeding is widely acknowledged as the normal method of infant feeding, there are large variations in rates of initiation and duration. Several factors are linked to the likelihood of breastfeeding initiation, including the influence and opinion of the child's father. There is limited research into men's perception of their influence, or if they feel it appropriate to be involved in deciding how to feed their children. The aim of this study was to investigate, using a qualitative methodology, fathers' perceptions of their influence on the decision to feed their child breastmilk or formula. Methods: Six men were recruited through Children's Centres in Bristol, United Kingdom, and a phenomenological research methodology implemented using semi-structured interviews. Specific objectives were: to understand participants' views on breastfeeding; understand if and how these views were discussed with their partner; to determine if participants believed involvement in the feeding decision is appropriate; to understand how they felt about the decision made; and to see if their views changed after the birth of their child. Results: Multiple themes emerged during analysis, including deferring of responsibility to the mother; breastfeeding as normal practice; change in attitude; involvement in parenting; and, advantages for the father. The men in the study accepted breastfeeding as normal behaviour, probably because of their upbringing in households where breastfeeding was practiced. There was consensus that women had more say in deciding to breastfeed, which was explained as a consequence of their greater involvement. It could also be interpreted as an unwillingness to interfere in an area perceived as 'owned' by women. Participants acknowledged that breastfeeding was more difficult than they had perceived. Conclusions: The key themes emerging from the interviews are suggestive of an impact on breastfeeding interventions that use the father as an intermediary. If they do not feel that they are 'permitted' to comment on their partner's breastfeeding, then simply increasing knowledge of breastfeeding benefits in these men is likely to have minimal impact

Discrimination of conventional and organic white cabbage from a long-term field trial study using untargeted LC-MS-based metabolomics

The influence of organic and conventional farming practices on the content of single nutrients in plants is disputed in the scientific literature. Here, large-scale untargeted LC-MS-based metabolomics was used to compare the composition of white cabbage from organic and conventional agriculture, measuring 1,600 compounds. Cabbage was sampled in 2 years from one conventional and two organic farming systems in a rigidly controlled long-term field trial in Denmark. Using Orthogonal Projection to Latent Structures-Discriminant Analysis (OPLS-DA), we found that the production system leaves a significant (p = 0.013) imprint in the white cabbage metabolome that is retained between production years. We externally validated this finding by predicting the production system of samples from one year using a classification model built on samples from the other year, with a correct classification in 83% of cases. Thus, it was concluded that the investigated conventional and organic management practices have a systematic impact on the metabolome of white cabbage. This emphasizes the potential of untargeted metabolomics for authenticity testing of organic plant products

Does crop diversity contribute to dietary diversity? Evidence from integration of vegetables into maize-based farming systems

Background: Maize is the most important staple crop for food security and livelihood of smallholder farmers in many parts of sub-Saharan Africa, but it alone cannot ensure food security. Cropping patterns must be diversified to ensure an adequate supply and economic access to greater variety of foods for smallholder farm households. This study measured the effect of crop diversification on household dietary diversity in a selected study locale using a survey of 300 randomly stratified farm households in 10 villages located in the Babati, Kongwa and Kiteto districts of Tanzania. Results: Based on multiple regression analysis, the study found that simply increasing Simpson’s Index does not influence dietary diversity of farm households due to the presence of interaction effect between Simpson’s Index and crop income. It is much more critical and significant to increase the revenue generated from diversified crops along with other socioeconomic endowment and behavioral characteristics of farm households. This is particularly applicable to poorer smallholder farmers who receive crop income less than US$85 per sales transaction and per season. Particularly, marginal and smallholders might be exposed to the effects of crop diversification and crop income toward increasing in their household dietary diversity score. Conclusion: Under average crop income scenarios, households that diversify their crop production tend to increase their dietary diversity from their existing dietary diversity score at a decreasing rate. However, under below average crop income threshold scenarios, farmers tend to increase their dietary diversity score from their existing score at an increasing rate when they diversify into high-value crops that attract relatively high farm gate values and accrue higher net revenues from the market. Monthly food expenditure also tends to positively influence household dietary diversity, indicating that farm households that spend more on market-purchased food have consistent increases in their dietary diversity scores at the household level. This study concludes that improving economic access to variety of foods at the smallholder household level by diversifying diets through increased crop diversification should be encouraged within maize-based farming systems of the study locale, through integration of micronutrient-rich foods such as vegetables

Validation of the Spanish Version of the ICECAP-O for Nursing Home Residents with Dementia

Background Measurement of health-related quality of life (HRQoL) is important for a chronic disease, such as dementia, which impairs the quality of life of affected patients in addition to their length of life. This is important in the context of economic evaluations when interventions do not (only) affect HRQoL and these other factors also affect overall quality of life. Objective To validate the Spanish translation of the ICECAP-O's capability to measure Health-related quality of life in elderly with dementia who live in nursing homes. Method Cross-sectional study. For 217 residents living in 8 Spanish nursing homes, questionnaires were completed by nursing professionals serving as proxy respondents. We analyzed the internal consistency and other psychometric properties. We investigated the convergent validity of the ICECAP-O with other HRQoL instruments, the EQ-5D extended with a cognitive dimension (EQ-5D+C), the Alzheimer's Disease Related Quality of Life (ADRQL) measures, and the Barthel Index measure of activities of daily living (ADL). Results The ICECAP-O presents satisfactory internal consistency (alpha 0.820). The factorial analysis indicated a structure of five principal dimensions that explain 66.57% of the total variance. Convergent validity between the ICECAP-O, EQ-5D+C, ADRQL, and Barthel Index scores was moderate to good (with correlations of 0.62, 0.61, and 0.68, respectively), but differed between dimensions of the instruments. Discriminant validity was confirmed by finding differences in ICECAP-O scores between subgroups based on ADL scores (0.70 low, 0.59 medium, and 0.39 high level care), dementia severity (0.72 mild, 0.63 medium, and 0.50 severe), and ages (0.59 below 75 years and 0.84 above 75 years). Conclusions This study presented the first use of a Spanish version of the ICECAP-O. The results indicate that the ICECAP-O appears to be a reliable Health-related quality of life measurement instrument showing good convergent and discriminant validity for people with dementia