Karen Burnell

Acceptance checklist for clinical effectiveness pilot trials: a systematic approach

Conducting a pilot trial is important in preparing for, and justifying investment in, the ensuing larger trial. Pilot trials using the same design and methods as the subsequent main trial are ethically and financially advantageous especially when pilot and main trial data can be pooled. For explanatory trials in which internal validity is paramount, there is little room for variation of methods between the pilot and main trial. For pragmatic trials, where generalisability or external validity is key, greater flexibility is written into trial protocols to allow for ‘real life’ variation in procedures. We describe the development of a checklist for use in decision-making on whether pilot data can be carried forward to the main trial dataset without compromising trial integrity. We illustrate the use of the checklist using a pragmatic trial of psychosocial interventions for family carers of people with dementia as a case study.

Causes of crises and appropriate interventions: The views of people with dementia, carers and healthcare professionals

The aims of this study were to identify which factors may lead to crisis for people with dementia and their carers and identify interventions these individuals believe could help in crisis. Qualitative study using focus groups to compare the perspectives of people with dementia, family carers and healthcare professionals on causes of crises and crisis interventions. To help in a crisis, people with dementia were favourable towards support from family and friends, access to mobile phones and home adaptations to reduce risks. Carers were keen on assistive technology and home adaptation. Both carers and staff valued carer training and education, care plans and well-coordinated care. Staff were the only group emphasizing more intensive interventions such as emergency home respite and extended hours services. In terms of causes of crises, people with dementia focused on risks and hazards in their home, whereas family carers emphasized carer stress and their own mental health problems. Staff, in contrast were concerned about problems with service organization and coordination leading to crises. Physical problems were less commonly identified as causes of crises but when they did occur they had a major impact. Practical interventions such as home adaptations, assistive technology, education and training for family carers, and flexible home care services were highly valued by service users and their families during times of crisis and may help prevent hospital admissions. Specialist home care was highly valued by all groups.

Coping with traumatic memories: second world war veterans' experiences of social support in relation to the narrative coherence of war memories

ABSTRACT This paper reports a qualitative study that used narrative analysis to explore how social support helps many armed-services veterans cope with traumatic memories. The analysis was carried out on two levels, that of narrative form (level of narrative coherence), argued to be indicative of reconciliation, and narrative content (themes of social support), which allowed exploration of the types of social support experienced by veterans with coherent, reconciled and incoherent narratives. Ten British male Second World War veterans were interviewed regarding their war experiences, presence of traumatic memories, and experiences of social support from comrades, family and society. Different patterns of support were qualitatively related to coherent, reconciled and incoherent narratives. Veterans with coherent narratives were no less likely to have experienced traumatic events than those with reconciled or incoherent narratives, but they reported more positive perceptions of their war experience and of the wars outcomes, more positive experiences of communication with family in later life, and more positive perceptions of societal opinion. The results are discussed in relation to how veterans can be supported by family and friends to reconcile their traumatic memories, thus to lessen the burden in later life when vital support resources may be unavailable.

Peer support for family carers of people with dementia, alone or in combination with group reminiscence in a factorial design: study protocol for a randomised controlled trial

BackgroundPeer support interventions can improve carer wellbeing and interventions that engage both the carer and person with dementia can have significant mutual benefits. Existing research has been criticised for inadequate rigour of design or reporting. This paper describes the protocol for a complex trial that evaluates one-to-one peer support and a group reminiscence programme, both separately and together, in a factorial design.DesignA 2 × 2 factorial multi-site randomised controlled trial of individual peer support and group reminiscence interventions for family carers and people with dementia in community settings in England, addressing both effectiveness and cost-effectiveness.DiscussionThe methods described in this protocol have implications for research into psychosocial interventions, particularly complex interventions seeking to test both individual and group approaches.Trial RegistrationISRCTN37956201

Peer support and reminiscence therapy for people with dementia and their family carers: a factorial pragmatic randomised trial

Objective The objective of this study was to evaluate peer support and reminiscence therapy, separately and together, in comparison with usual care for people with dementia and their family carers. Design Factorial pragmatic randomised trial, analysed by treatment allocated, was used for this study. Setting The trial ran in Community settings in England. Participants People with dementia and their family carers were the participants. Interventions Treatment as usual (TAU) plus one of the following: one-to-one peer support to family carers from experienced carers (Carer Supporter Programme; CSP), group reminiscence therapy (Remembering Yesterday, Caring Today; RYCT) for people with dementia and carers, both or neither. Main outcome measures Primary outcomes included health-related quality of life (SF-12) for carers and quality of life (QoL-AD) for people with dementia; secondary outcomes included quality of relationship for carers and people with dementia; both were collected by blinded assessors at baseline, 5 and 12 months (primary end point). Results Of 291 pairs recruited, we randomised 145 (50%) to CSP (71% uptake) and 194 (67%) to RYCT (61% uptake). CSP and RYCT, separately or together, were not effective in improving primary outcomes or most secondary outcomes. For CSP versus ‘no CSP’, adjusted difference in means was 0.52 points on the SF-12 (95% CI −1.28 to 2.32) and −0.08 points on the QoL-AD (95% CI −1.70 to 1.56). For RYCT versus ‘no RYCT’, the difference was 0.10 points on the SF-12 (95% CI −1.72 to 1.93) and 0.51 points on the QoL-AD (95% CI −1.17 to 2.08). However, carers reported better relationships with the people with dementia (difference 1.11, 95% CI 0.00 to 2.21, p=0.05). Comparison of combined intervention with TAU, and of intervention received, suggested differential impacts for carers and persons with dementia. Conclusions There is no evidence from the trial that either peer support or reminiscence is effective in improving the quality of life. Trial registration number ISRCTN37956201; Results.

Involving service users in the development of the Support at Home:interventions to enhance life in Dementia Carer Supporter Programme for family carers of people with dementia

Involving service users in research can be an effective way of improving the practicalities and acceptability of interventions for target end users.

Service users’ involvement in the development of a maintenance cognitive stimulation therapy (CST) programme: A comparison of the views of people with dementia, staff and family carers

This study reports on the process of developing a maintenance programme manual following the Medical Research Council guidelines representing the ‘phase I’ or modelling. This study uses an inductive thematic analysis approach to examine user perceptions on the maintenance cognitive stimulation therapy (CST) programme. Three focus groups were carried out with people with dementia, three with staff, and three with family carers of people with dementia. In total 17 people with dementia, 13 staff and 18 family carers took part in separate focus groups. The main findings from the user focus clearly supports the recent draft NICE guidelines on dementia (NICE‐SCIE, 2006) that states that all people with mild/moderate dementia should be ‘given the opportunity to participate in a structured group of cognitive stimulation programme’. People with dementia highly valued the opportunity to take part in a mental stimulating group programme and found it vital in keeping them healthy and active. Most family carers and staff were very positive but expressed concerns about the effectiveness of this type of programme and gave real life examples where the idea of ‘use it or lose it’ did not apply. Results from the focus groups will be used in order to produce a new version of the maintenance CST draft manual and this will be evaluated in a large randomized controlled trial (RCT).

Exploring the suitability and acceptability of peer support for older veterans

Purpose Informal social support is often sought by veterans to support reminiscence or cope with traumatic memories. However, it can also encourage unhelpful ways of coping, such as avoidance, or may be absent altogether. This project is borrowed from the growing peer support literature. The purpose of this paper is to explore the suitability of peer support services to enhance the wellbeing for older veterans, when naturally occurring support is absent or unhelpful. Design/methodology/approach This was a sequentially staged research programme involving a scoping review of current practice and evidence, and a consultation with veterans. In total, ten veterans (nine male, one female) took part in the consultation (M=66 years). Findings Peer support was considered suitable, particularly in addressing loneliness and social isolation. There was an understandable concern regarding its use with more complex issues such as trauma. An added issue was the implicit assumption that this consultation concerned transition; supporting younger veteran as they move from military to civilian life. This mirrored the focus of current UK policy and affected the focus of the consultation. Issues were also raised around the sustainability of services more broadly. Social implications Peer support is appropriate in supporting older veterans, but must be implemented in a sustainable way. Raising awareness of the needs of older veterans in older adult services is an important implication for service development and delivery. Originality/value There is a considerable lack of research concerning older veterans, particularly concerning their formal and informal social support needs. This paper addresses the current gap in the literature.