PMCC PMCC

Search tips
Search criteria

Advanced
Results 1-4 (4)
 

Clipboard (0)
None
Journals
Authors
more »
Year of Publication
Document Types
1.  The ETTAA study protocol: a UK-wide observational study of ‘Effective Treatments for Thoracic Aortic Aneurysm’ 
BMJ Open  2015;5(6):e008147.
Introduction
Chronic thoracic aortic aneurysm (CTAA) affecting the arch or descending aorta is an indolent but life-threatening condition with a rising prevalence as the UK population ages. Treatment may be in the form of open surgical repair (OSR) surgery, endovascular stent grafting (ESG) or best medical therapy (BMT). Currently, there is no consensus on the best management strategy, and no UK-specific economic studies that assess outcomes beyond the chosen procedure, but this is required in the context of greater demand for treatment and limited National Health Service (NHS) resources.
Methods and analysis
This is a prospective, multicentre observational study with statistical and economic modelling of patients with CTAA affecting the arch or descending aorta. We aim to gain an understanding of how treatments are currently chosen, and to determine the clinical effectiveness and cost-effectiveness of the three available treatment strategies (BMT, ESG and OSR). This will be achieved by: (1) following consecutive patients who are referred to the teams collaborating in this proposal and collecting data regarding quality of life (QoL), medical events and hospital stays over a maximum of 5 years; (2) statistical analysis of the comparative effectiveness of the three treatments; and (3) economic modelling of the comparative cost-effectiveness of the three treatments. Primary study outcomes are: aneurysm growth, QoL, freedom from reintervention, freedom from death or permanent neurological injury, incremental cost per quality-adjusted life year gained.
Ethics and dissemination
The study will generate an evidence base to guide patients and clinicians to determine the indications and timing of treatment, as well as informing healthcare decision-makers about which treatments the NHS should provide. The study has achieved ethical approval and will be disseminated primarily in the form of a Health Technology Assessment monograph at its completion.
Trial registration number
ISRCTN04044627.
doi:10.1136/bmjopen-2015-008147
PMCID: PMC4458682  PMID: 26038360
VASCULAR MEDICINE
2.  Does quality of life improve in octogenarians following cardiac surgery? A systematic review 
BMJ Open  2015;5(4):e006904.
Objectives
Current outcome measures in cardiac surgery are largely described in terms of mortality. Given the changing demographic profiles and increasingly aged populations referred for cardiac surgery this may not be the most appropriate measure. Postoperative quality of life is an outcome of importance to all ages, but perhaps particularly so for those whose absolute life expectancy is limited by virtue of age. We undertook a systematic review of the literature to clarify and summarise the existing evidence regarding postoperative quality of life of older people following cardiac surgery. For the purpose of this review we defined our population as people aged 80 years of age or over.
Methods
A systematic review of MEDLINE, EMBASE, Cochrane Library, trial registers and conference abstracts was undertaken to identify studies addressing quality of life following cardiac surgery in patients 80 or over.
Results
Forty-four studies were identified that addressed this topic, of these nine were prospective therefore overall conclusions are drawn from largely retrospective observational studies. No randomised controlled data were identified.
Conclusions
Overall there appears to be an improvement in quality of life in the majority of elderly patients following cardiac surgery, however there was a minority in whom quality of life declined (8–19%). There is an urgent need to validate these data and if correct to develop a robust prediction tool to identify these patients before surgery. Such a tool could guide informed consent, policy development and resource allocation.
doi:10.1136/bmjopen-2014-006904
PMCID: PMC4420984  PMID: 25922099
GERIATRIC MEDICINE
3.  Process evaluation for the FEeding Support Team (FEST) randomised controlled feasibility trial of proactive and reactive telephone support for breastfeeding women living in disadvantaged areas 
BMJ Open  2012;2(2):e001039.
Objective
To assess the feasibility, acceptability and fidelity of a feeding team intervention with an embedded randomised controlled trial of team-initiated (proactive) and woman-initiated (reactive) telephone support after hospital discharge.
Design
Participatory approach to the design and implementation of a pilot trial embedded within a before-and-after study, with mixed-method process evaluation.
Setting
A postnatal ward in Scotland.
Sample
Women initiating breast feeding and living in disadvantaged areas.
Methods
Quantitative data: telephone call log and workload diaries. Qualitative data: interviews with women (n=40) with follow-up (n=11) and staff (n=17); ward observations 2 weeks before and after the intervention; recorded telephone calls (n=16) and steering group meetings (n=9); trial case notes (n=69); open question in a telephone interview (n=372). The Framework approach to analysis was applied to mixed-method data.
Main outcome measures
Quantitative: telephone call characteristics (number, frequency, duration); workload activity. Qualitative: experiences and perspectives of women and staff.
Results
A median of eight proactive calls per woman (n=35) with a median duration of 5 min occurred in the 14 days following hospital discharge. Only one of 34 control women initiated a call to the feeding team, with women undervaluing their own needs compared to others, and breast feeding as a reason to call. Proactive calls providing continuity of care increased women's confidence and were highly valued. Data demonstrated intervention fidelity for woman-centred care; however, observing an entire breast feed was not well implemented due to short hospital stays, ward routines and staff–team–woman communication issues. Staff pragmatically recognised that dedicated feeding teams help meet women's breastfeeding support needs in the context of overstretched and variable postnatal services.
Conclusions
Implementing and integrating the FEeding Support Team (FEST) trial within routine postnatal care was feasible and acceptable to women and staff from a research and practice perspective and shows promise for addressing health inequalities.
Trial registration
ISRCTN27207603. The study protocol and final report is available on request.
Article summary
Article focus
To use a participatory approach to design, deliver and implement a feeding support team intervention integrated into routine postnatal ward care and to deliver a pilot randomised controlled trial (RCT) of proactive and reactive telephone support for breast feeding for up to 14 days after hospital discharge for women living in more disadvantaged areas.
To use a mixed qualitative and quantitative methods process evaluation to assess the study acceptability, feasibility and intervention fidelity from the perspectives of women and National Health Service staff.
To inform the design of a future definitive RCT.
Key messages
Women living in disadvantaged areas are unlikely to initiate calls for help with breast feeding and proactive telephone calls may help to counteract the inverse care law.
Women undervalue both breast feeding and their own needs compared with the needs of others as a reason to ask for help in the context of overstretched maternity services.
A caring, reassuring woman-centred communication style with continuity of care from hospital to home was valued and increased women's confidence.
Strengths and limitations of this study
The participatory approach embedding a rigorous RCT within a before-and-after cohort study with mixed-methods data to evaluate implementation processes and costs are strengths that will enable us to design a feasible and acceptable definitive trial.
The contribution of the personal characteristics and skills of the feeding team to the intervention was important and may be challenging to replicate.
The low number of women who reported having an entire breast feed observed is a limitation and warrants further investigation.
More research is required before feeding teams and proactive calls are widely implemented as there are likely to be unintended consequences to such an organisational change in postnatal care.
doi:10.1136/bmjopen-2012-001039
PMCID: PMC3341595  PMID: 22535794
4.  The FEeding Support Team (FEST) randomised, controlled feasibility trial of proactive and reactive telephone support for breastfeeding women living in disadvantaged areas 
BMJ Open  2012;2(2):e000652.
Objective
To assess the feasibility of implementing a dedicated feeding support team on a postnatal ward and pilot the potential effectiveness and cost-effectiveness of team (proactive) and woman-initiated (reactive) telephone support after discharge.
Design
Randomised controlled trial embedded within a before-and-after study. Participatory approach and mixed-method process evaluation.
Setting
A postnatal ward in Scotland.
Sample
Women living in disadvantaged areas initiating breast feeding.
Methods
Eligible women were recruited to a before-and-after intervention study, a proportion of whom were independently randomised after hospital discharge to intervention: daily proactive and reactive telephone calls for ≤14 days or control: reactive telephone calls ≤ day 14. Intention-to-treat analysis compared the randomised groups on cases with complete outcomes at follow-up.
Main outcome measures
Primary outcome: any breast feeding at 6–8 weeks assessed by a telephone call from a researcher blind to group allocation. Secondary outcomes: exclusive breast feeding, satisfaction with care, NHS costs and cost per additional woman breast feeding.
Results
There was no difference in feeding outcomes for women initiating breast feeding before the intervention (n=413) and after (n=388). 69 women were randomised to telephone support: 35 intervention (32 complete cases) and 34 control (26 complete cases). 22 intervention women compared with 12 control women were giving their baby some breast milk (RR 1.49, 95% CI 0.92 to 2.40) and 17 intervention women compared with eight control women were exclusively breast feeding (RR 1.73, 95% CI 0.88 to 3.37) at 6–8 weeks after birth. The incremental cost of providing proactive calls was £87 per additional woman breast feeding and £91 per additional woman exclusively breast feeding at 6–8 weeks; costs were sensitive to service organisation.
Conclusions
Proactive telephone care delivered by a dedicated feeding team shows promise as a cost-effective intervention for improving breastfeeding outcomes. Integrating the FEeding Support Team (FEST) intervention into routine postnatal care was feasible.
Trial registration number
ISRCTN27207603. The study protocol and final report are available on request.
Article summary
Article focus
To pilot the potential effectiveness and cost-effectiveness of continuing proactive and reactive telephone support for breast feeding for up to 14 days after hospital discharge for women living in more disadvantaged areas.
To assess the feasibility of implementing a dedicated feeding team on a postnatal ward.
To design an effective health service intervention for infant feeding by re-organising how routine care is provided to inform a larger programme of research.
Key messages
Proactive telephone care delivered by a dedicated feeding team shows promise for increasing breastfeeding rates 6–8 weeks after birth.
Only having a dedicated feeding team on a postnatal ward did not appear to make any difference to feeding outcomes at 6–8 weeks after birth.
We have demonstrated the feasibility of (1) implementing the FEeding Support Team intervention as part of routine postnatal care and (2) the recruitment and data collection processes for a proposed definitive trial.
Strengths and limitations of this study
Using a participatory approach and embedding a rigorous randomised control trial within a before-and-after cohort study with mixed methods data to evaluate costs are strengths that will enable us to design a definitive trial.
It is likely that the effect sizes are overestimated as the sample size was small and no sample size calculation was performed prior to the study.
Our sample included women requiring longer hospital stays due to birth complications.
The reactive call service was only free to those who had the same mobile phone network provider.
The incremental cost-effectiveness ratios presented represent the most favourable set of assumptions for proactive telephone support and are sensitive to how the service is organised.
doi:10.1136/bmjopen-2011-000652
PMCID: PMC3341594  PMID: 22535790

Results 1-4 (4)