The Diabetes Manual trial protocol – a cluster randomized controlled trial of a self-management intervention for type 2 diabetes [ISRCTN06315411]

Background The Diabetes Manual is a type 2 diabetes self-management programme based upon the clinically effective 'Heart Manual'. The 12 week programme is a complex intervention theoretically underpinned by self-efficacy theory. It is a one to one intervention meeting United Kingdom requirements for structured diabetes-education and is delivered within routine primary care. Methods/design In a two-group cluster randomized controlled trial, GP practices are allocated by computer minimisation to an intervention group or a six-month deferred intervention group. We aim to recruit 250 participants from 50 practices across central England. Eligibility criteria are adults able to undertake the programme with type 2 diabetes, not taking insulin, with HbA1c over 8% (first 12 months) and following an agreed protocol change over 7% (months 13 to 18). Following randomisation, intervention nurses receive two-day training and delivered the Diabetes Manual programme to participants. Deferred intervention nurses receive the training following six-month follow-up. Primary outcome is HbA1c with total and HDL cholesterol; blood pressure, body mass index; self-efficacy and quality of life as additional outcomes. Primary analysis is between-group HbA1c differences at 6 months powered to give 80% power to detect a difference in HbA1c of 0.6%. A 12 month cohort analysis will assess maintenance of effect and assess relationship between self-efficacy and outcomes, and a qualitative study is running alongside. Discussion This trial incorporates educational and psychological diabetes interventions into a single programme and assesses both clinical and psychosocial outcomes. The trial will increase our understanding of intervention transferability between conditions, those diabetes related health behaviours that are more or less susceptible to change through efficacy enhancing mechanisms and how this impacts on clinical outcomes

Comment on Young-Hyman et al. Psychosocial care for people with diabetes: A position statement of the American Diabetes Association. Diabetes Care 2016;39:2126–2140

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Geo-statistical methods to analyse changes in pre-Hispanic settlement patterns in the Río Ica catchment, Peru

Within arid regions allochthonous rivers as a main source of fresh water play a significant role in the spatial organisation of human occupation.This study aims at a comprehensive view on changes in the prehistoric occupation patterns within the Río Ica catchment on the southern coast of Peru. Results of different research projects are integrated. The heterogeneous character of the catchment allows us to define three sub-sections which differ greatly in terms of vegetation, relief and water regime.Based on quantitative geo-statistical methods we analyse spatio-temporal changes in human occupation from the Early Horizon (c. 1000–200 BC) through to the Inca Late Horizon (AD 1450–1532) in the context of environmental conditions, as well as socio-economic processes. Examining known archaeological sites we are able to assess the significance of environmental location factors for pre-Hispanic settlements. In addition, areas of high human interaction are identified on the basis of a classification of archaeological sites according to their function (craft/industry, cult, cooperation and trade). We thereby transfer the concept of central place theory to the spatial distribution of archaeological remains, introducing a novel approach to identifying central functions in a spatially explicit way.Our results crystallise the changing character of occupation in the study area over more than two millennia. They contribute to the ongoing debate on the decline of the Nasca culture, endorsing a complex combination of natural and socio-economic reasons. Furthermore, the results support the concept of a more widespread exchange and cooperation during ‘Horizon’ periods in the study area and likewise indicate that the disappearance of a supra-regional administrative polity during ‘Intermediate’ periods might have led to higher human activity in smaller scale societies, as reflected in a more diverse spatial organisation in terms of geomorphometric units and central areas

International feasibility study for the Women's Wellness with Type 2 Diabetes Programme (WWDP): An eHealth enabled 12-week intervention programme for midlife women with type 2 diabetes.

AimsThe current study aimed to examine feasibility of participant recruitment and retention rates for the Women's Wellness with Type 2 Diabetes program (WWDP), and to assess initial efficacy of the program in improving wellbeing outcomes.Methods70 midlife women with type 2 diabetes mellitus (T2DM) participated in a 12-week wellness-focused intervention, the WWDP. The WWDP involved a structured book (with participatory activities), an interactive website and nurse consultations. This study had an Australian and a UK arm. Analyses were conducted using chi-square, McNemar, paired t-test, and Wilcoxon signed-ranks tests.ResultsThe attrition rate for the sample was 22.2%. Overall, significant improvement was observed in diabetes distress (DD), diabetes self-efficacy, weight, BMI, menopausal symptoms and sleep symptoms from baseline to program completion at 12 weeks. Australian participants were also more likely to meet fruit recommendation guidelines and had significant waist- and hip-circumference reductions.ConclusionsGood retention rates and initial efficacy findings indicated feasibility of the WWDP as a promising 12-week health and wellness program for women with T2DM. They also suggest incorporating a focus on self-efficacy and gendered information may be important in improving wellness and health outcomes related to distress and menopause

Timely digital patient-clinician communication in specialist clinical services for young people : a mixed-methods study (the LYNC study)

BACKGROUND: Young people (aged 16-24 years) with long-term health conditions can disengage from health services, resulting in poor health outcomes, but clinicians in the UK National Health Service (NHS) are using digital communication to try to improve engagement. Evidence of effectiveness of this digital communication is equivocal. There are gaps in evidence as to how it might work, its cost, and ethical and safety issues. OBJECTIVE: Our objective was to understand how the use of digital communication between young people with long-term conditions and their NHS specialist clinicians changes engagement of the young people with their health care; and to identify costs and necessary safeguards. METHODS: We conducted mixed-methods case studies of 20 NHS specialist clinical teams from across England and Wales and their practice providing care for 13 different long-term physical or mental health conditions. We observed 79 clinical team members and interviewed 165 young people aged 16-24 years with a long-term health condition recruited via case study clinical teams, 173 clinical team members, and 16 information governance specialists from study NHS Trusts. We conducted a thematic analysis of how digital communication works, and analyzed ethics, safety and governance, and annual direct costs. RESULTS: Young people and their clinical teams variously used mobile phone calls, text messages, email, and voice over Internet protocol. Length of clinician use of digital communication varied from 1 to 13 years in 17 case studies, and was being considered in 3. Digital communication enables timely access for young people to the right clinician at the time when it can make a difference to how they manage their health condition. This is valued as an addition to traditional clinic appointments and can engage those otherwise disengaged, particularly at times of change for young people. It can enhance patient autonomy, empowerment and activation. It challenges the nature and boundaries of therapeutic relationships but can improve trust. The clinical teams studied had not themselves formally evaluated the impact of their intervention. Staff time is the main cost driver, but offsetting savings are likely elsewhere in the health service. Risks include increased dependence on clinicians, inadvertent disclosure of confidential information, and communication failures, which are mostly mitigated by young people and clinicians using common-sense approaches. CONCLUSIONS: As NHS policy prompts more widespread use of digital communication to improve the health care experience, our findings suggest that benefit is most likely, and harms are mitigated, when digital communication is used with patients who already have a relationship of trust with the clinical team, and where there is identifiable need for patients to have flexible access, such as when transitioning between services, treatments, or lived context. Clinical teams need a proactive approach to ethics, governance, and patient safety

Re-evaluating the resource potential of lomas fog oasis environments for Preceramic hunter-gatherers under past ENSO modes on the south coast of Peru

Lomas – ephemeral seasonal oases sustained by ocean fogs – were critical to ancient human ecology on the desert Pacific coast of Peru: one of humanity’s few independent hearths of agriculture and “pristine” civilisation. The role of climate change since the Late Pleistocene in determining productivity and extent of past lomas ecosystems has been much debated. Here we reassess the resource potential of the poorly studied lomas of the south coast of Peru during the long Middle Pre-ceramic period (c. 8,000 – 4,500 BP): a period critical in the transition to agriculture, the onset of modern El Niño Southern Oscillation (‘ENSO’) conditions, and eustatic sea-level rise and stabilisation and beach progradation. Our method combines vegetation survey and herbarium collection with archaeological survey and excavation to make inferences about both Preceramic hunter-gatherer ecology and the changed palaeoenvironments in which it took place. Our analysis of newly discovered archaeological sites – and their resource context – show how lomas formations defined human ecology until the end of the Middle Preceramic Period, thereby corroborating recent reconstructions of ENSO history based on other data. Together, these suggest that a five millennia period of significantly colder seas on the south coast induced conditions of abundance and seasonal predictability in lomas and maritime ecosystems, that enabled Middle Preceramic hunter-gatherers to reduce mobility by settling in strategic locations at the confluence of multiple eco-zones at the river estuaries. Here the foundations of agriculture lay in a Broad Spectrum Revolution that unfolded, not through population pressure in deteriorating environments, but rather as an outcome of resource abundance.We thank the Ministerio de Cultural del Perú for granting permission for archaeological fieldwork (Resolución Directoral Nº 933-2012-DGPC-VMPCIC/MC, 19 December 2012 and Nº 386-2014-DGPA-VMPCIC/MC, 22 August 2014) and the export of samples for dating; Don Alberto Benavides Ganoza and the people of Samaca for facilitating fieldwork; the Leverhulme Trust (grant number RPG-117) and the late Don Alberto Benavides de la Quintana (grant number RG69428) and the McDonald Institute for Archaeological Research for funding Cambridge University’s One River Archaeological Project, and the NERC Radiocarbon facility (grant number NF/2013/2/2) for funding radiocarbon dating. We also thank the Servicio Nacional Forestal y de Fauna Silvestre (SERFOR) and the Servicio Nacional de Áreas Naturales Protegidas por el Estado (SERNANP), Peru for permits for the Proyecto Kew Perú to carry out botanical and ecological survey, and Delsy Trujillo, Eric Ramírez, Consuelo Borda and other participants of the Proyecto Kew Perú: Conservación, Restauración de Hábitats y Medios de Vida Útiles, Ica, Peru.This is the final version of the article. It first appeared from Elsevier via http://dx.doi.org/10.1016/j.quascirev.2015.10.02

Eliciting the Impact of Digital Consulting for Young People Living With Long-term Conditions (Lync Study): Cognitive Interviews to Assess the Face and Content Validity of Two Patient-Reported Outcome Measures

BACKGROUND: Digital consulting, using email, text, and Skype, is increasingly offered to young people accessing specialist care for long-term conditions. No patient-reported outcome measures (PROMs) have been evaluated for assessing outcomes of digital consulting. Systematic and scoping reviews, alongside patient involvement, revealed 2 candidate PROMs for this purpose: the patient activation measure (PAM) and the physician’s humanistic behaviors questionnaire (PHBQ). PAM measures knowledge, beliefs, and skills that enable people to manage their long-term conditions. PHBQ assesses the presence of behaviors that are important to patients in their physician-patient interactions. OBJECTIVE: This study aimed to assess the face and content validity of PAM and PHBQ to explore whether they elicit important outcomes of digital consulting and whether the PROMs can isolate the digital consultation component of care. METHODS: Participants were drawn from 5 clinics providing specialist National Health Service care to 16- to 24-year-olds with long-term health conditions participating in the wider LYNC (Long-Term Conditions, Young People, Networked Communications) study. Overall, 14 people undertook a cognitive interview in this substudy. Of these, 7 participants were young people with either inflammatory bowel disease, cystic fibrosis, or cancer. The remaining 7 participants were clinicians who were convenience sampled. These included a clinical psychologist, 2 nurses, 3 consultant physicians, and a community youth worker practicing in cancer, diabetes, cystic fibrosis, and liver disease. Cognitive interviews were transcribed and analyzed, and a spreadsheet recorded the participants’ PROM item appraisals. Illustrative quotes were extracted verbatim from the interviews for all participants. RESULTS: Young people found 11 of the PAM 13 items and 7 of the additional 8 PAM 22 items to be relevant to digital consulting. They were only able to provide spontaneous examples of digital consulting for 50% (11/22) of the items. Of the 7 clinicians, 4 appraised all PAM 13 items and 20 of the PAM 22 items to be relevant to evaluating digital consulting and articulated operationalization of the items with reference to their own digital consulting practice with greater ease than the young people. Appraising the PHBQ, in 14 of the 25 items, two-thirds of the young people’s appraisals offered digital consulting examples with ease, suggesting that young people can detect and discern humanistic clinician behaviors via digital as well as face-to-face communication channels. Moreover, 17 of the 25 items were appraised as relevant by the young people. This finding was mirrored in the clinician appraisals. Both young people and the clinicians found the research task complex. Young participants required considerably more researcher prompting to elicit examples related to digital consulting rather than their face-to-face care. CONCLUSIONS: PAM and PHBQ have satisfactory face and content validity for evaluating digital consulting to warrant proceeding to psychometric evaluation. Completion instructions require revision to differentiate between digital and face-to-face consultations

Process evaluation for complex interventions in primary care: understanding trials using the normalization process model

Background: the Normalization Process Model is a conceptual tool intended to assist in understanding the factors that affect implementation processes in clinical trials and other evaluations of complex interventions. It focuses on the ways that the implementation of complex interventions is shaped by problems of workability and integration.Method: in this paper the model is applied to two different complex trials: (i) the delivery of problem solving therapies for psychosocial distress, and (ii) the delivery of nurse-led clinics for heart failure treatment in primary care.Results: application of the model shows how process evaluations need to focus on more than the immediate contexts in which trial outcomes are generated. Problems relating to intervention workability and integration also need to be understood. The model may be used effectively to explain the implementation process in trials of complex interventions.Conclusion: the model invites evaluators to attend equally to considering how a complex intervention interacts with existing patterns of service organization, professional practice, and professional-patient interaction. The justification for this may be found in the abundance of reports of clinical effectiveness for interventions that have little hope of being implemented in real healthcare setting

Enhancement and suppression effects resulting from information structuring in sentences

Information structuring through the use of cleft sentences increases the processing efficiency of references to elements within the scope of focus. Furthermore, there is evidence that putting certain types of emphasis on individual words not only enhances their subsequent processing, but also protects these words from becoming suppressed in the wake of subsequent information, suggesting mechanisms of enhancement and suppression. In Experiment 1, we showed that clefted constructions facilitate the integration of subsequent sentences that make reference to elements within the scope of focus, and that they decrease the efficiency with reference to elements outside of the scope of focus. In Experiment 2, using an auditory text-change-detection paradigm, we showed that focus has similar effects on the strength of memory representations. These results add to the evidence for enhancement and suppression as mechanisms of sentence processing and clarify that the effects occur within sentences having a marked focus structure