When does NICE recommend the use of health technologies within a programme of evidence development?

This article is made available through the Brunel Open Access Publishing Fund. This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.This article has been made available through the Brunel Open Access Publishing Fund.Background: There is growing interest internationally in linking reimbursement decisions with recommendations for further research. In the UK, the National Institute for Health and Clinical Excellence (NICE) can issue guidance to approve the routine use of a health intervention, reject routine use or recommend use within a research programme. These latter recommendations have restricted use to ‘only in research’ (OIR) or have recommended further research alongside routine use (‘approval with research’ or AWR). However, it is not currently clear when such recommendations are likely to be made. Objectives: This study aims to identify NICE technology appraisals where OIR or AWR recommendations were made and to examine the key considerations that led to those decisions. Methods: Draft and final guidance including OIR/AWR recommendations were identified. The documents were reviewed to establish the characteristics of the technology appraisal, the cost effectiveness of the technologies, the key considerations that led to the recommendations and the types of research required. Results: In total, 29 final and 31 draft guidance documents included OIR/AWR recommendations up to January 2010. Overall, 86 % of final guidance included OIR recommendations. Of these, the majority were for technologies considered to be cost ineffective (83 %) and the majority of final guidance (66 %) specified the need for further evidence on relative effectiveness. The use of OIR/AWR recommendations is decreasing over time and they have rarely been used in appraisals conducted through the single technology appraisal process. Conclusion: NICE has used its ability to recommend technologies within research programmes, although predominantly within the multiple technology appraisal process. OIR recommendations have been most frequently issued for technologies considered cost ineffective and the most frequently cited consideration is uncertainty related to relative effectiveness. Key considerations cited for most AWR recommendations and some OIR recommendations included a need for further evidence on long-term outcomes and adverse effects of treatment.Medical Research Counci

Effects of the diabetes manual 1:1 structured education in primary care

Aims  To determine the effects of the Diabetes Manual on glycaemic control, diabetes-related distress and confidence to self-care of patients with Type 2 diabetes. Methods  A cluster randomized, controlled trial of an intervention group vs. a 6-month delayed-intervention control group with a nested qualitative study. Participants were 48 urban general practices in the West Midlands, UK, with high population deprivation levels and 245 adults with Type 2 diabetes with a mean age of 62 years recruited pre-randomization. The Diabetes Manual is 1:1 structured education designed for delivery by practice nurses. Measured outcomes were HbA1c, cardiovascular risk factors, diabetes-related distress measured by the Problem Areas in Diabetes Scale and confidence to self-care measured by the Diabetes Management Self-Efficacy Scale. Outcomes were assessed at baseline and 26 weeks. Results  There was no significant difference in HbA1c between the intervention group and the control group [difference −0.08%, 95% confidence interval (CI) −0.28, 0.11]. Diabetes-related distress scores were lower in the intervention group compared with the control group (difference −4.5, 95% CI −8.1, −1.0). Confidence to self-care Scores were 11.2 points higher (95% CI 4.4, 18.0) in the intervention group compared with the control group. The patient response rate was 18.5%. Conclusions  In this population, the Diabetes Manual achieved a small improvement in patient diabetes-related distress and confidence to self-care over 26 weeks, without a change in glycaemic control. Further study is needed to optimize the intervention and characterize those for whom it is more clinically and psychologically effective to support its use in primary care

Gaining consensus on family carer needs when caring for someone dying at home to develop the Carers' Alert Thermometer (CAT): a modified Delphi study

Aim To report a multi-phase modified Delphi study conducted with carers and professionals to identify the priority areas for inclusion in an alert screening tool for carers providing support to someone dying at home. Background Internationally, there is a growing emphasis on increasing choice for patients who wish to die at home which relies heavily on care provided by the unpaid family carers. Family carers can have high levels of unmet needs comprising their psychological and physical health and their ability to provide effective care and support. Development of an alert tool to identify carers' needs in everyday practice required identification and consensus of the priority areas of need for inclusion. Design Multi-phase modified Delphi study and instrument development. Method Qualitative and quantitative data collection took place between 2011–2013 with 111 carers and 93 professionals to identify carers' needs and gain consensus on the priority areas for inclusion in the alert tool. An expert panel stage and final evidence review post-Delphi were used. Results The Delphi panels had high levels of agreement and consensus. Ten areas of carer need across two themes of ‘the current caring situation’ and ‘the carer's own health and well-being’ were prioritized for inclusion in the alert tool. An optional end-of-life planning question was included following the final stages. Conclusions The results provide evidence of carers' needs to be assessed, areas for consideration in the education of those who support carers and someone dying at home and targeting of services, while demonstrating the usefulness and adaptability of the Delphi method

Staff experiences and understandings of the REsTRAIN Yourself initiative to minimise the use of physical restraint on mental health wards

International efforts to minimize coercive practices include the US Six Core Strategies© (6CS). This innovative approach has limited evidence of its effectiveness, with few robustly designed studies, and has not been formally implemented or evaluated in the UK. An adapted version of the 6CS, which we called ‘REsTRAIN Yourself’ (RY), was devised to suit the UK context and evaluated using mixed methods. RY aimed to reduce the use of physical restraint in mental health inpatient ward settings through training and practice development with whole teams, directly in the ward settings where change is to be implemented and barriers to change overcome. In this paper we present qualitative findings that report on staff perspectives on the impact and value of RY following its implementation. Thirty-six staff participated in semi-structured interviews with data subject to thematic analysis. Eight themes are reported that highlight perceived improvements in every domain of the 6CS after RY had been introduced. Staff reported more positively on their relationships with service users and felt their attitudes towards the use of coercive practices such as restraint were changed; the service as a whole shifted in terms of restraint awareness and reduction; and new policies, procedures and language were introduced despite certain barriers. These findings need to be appreciated in a context wherein substantial reductions in the use of physical restraint was proven possible, largely due to building upon empathic and relational alternatives. However, yet more could be achieved with greater resourcing of inpatient care

Would a student midwife run postnatal clinic make a valuable addition to midwifery education in the UK? - A systematic review

Background – There is growing evidence in the UK that some National Health Service improvements, particularly in the postnatal period, are having an impact on the quality and variety of student midwives’ clinical experiences, making it challenging for them to meet the standards set by the regulatory body for midwives and receive a licence to practice. A possible solution to this may be the introduction of a Student Midwife integrated Learning Environment (SMiLE) focusing upon the delivery of postnatal care (PN) through a student run clinic Objective - To identify the current state of knowledge, regarding the educational outcomes of students who engage with student run clinics (SRC) and the satisfaction of patients who attend them Search strategy - BNI, CINAHL, EMBASE, MEDLINE were searched for articles published until April 2014. Selection criteria - Studies nationally and internationally, that were carried out on healthcare students running their own clinics. Outcome measures were the evaluation of educational outcomes of students and client satisfaction were included Data collection and analysis - Data were extracted, analysed and synthesised to produce a summary of knowledge, regarding the effectiveness of SRC’s Main results - 6 studies were selected for this review Authors conclusions – The findings that SRC can offer advantages in improving educational outcomes of students and provide an effective service to clients is encouraging. However, given the limited number of high-quality studies included in this review, further research is required to investigate the effectiveness of SR

The effectiveness and cost-effectiveness of a participative community singing programme as a health promotion initiative for older people: protocol for a randomised controlled trial

Background The growth in numbers of older people represents a considerable cost to health and social care services in the United Kingdom. There is an acknowledged need to address issues of social exclusion and both the physicial and mental health of this age group. In recent years there has been much interest in the potential contribution of the arts to the health of communities and individuals. There is some evidence that participative singing may be of benefit to older people, however studies to date are limited in number and have lacked rigour. There is therefore a need to build on this knowledge base to provide more quantifiable evidence of both effectiveness and cost efffectness of singing as a health intervention of this population group. Methods The proposed study is a pragmatic randomised controlled trial with two parallel arms. The primary hypothesis is that singing groups for older people improve both physical and mental aspects of qualaity of life when compared to usual activities. Potential participants will be volunteers over 60 years living in the community and recruited through publicity. Eligible and consenting participants will be randomized to either a singing group or a control group. Singing groups will take part in a twelve week planned programme of singing and control groups will continue with usual activities. The primary outcome measure will be the York SF-12, a health related quality of life measure which will be administered at baseline, three and six months after baseline. The study will evaluate both effectiveness and cost-effectiveness. Discussion This study proposes to add to the exisiting body of evidence on the value of singing for older people by using a rigorous methodological design, which includes a power calucation, a standardised intervention and assessment of cost-effectiveness. It should be regarded as a stage in a progressive programme of studies in this area. If group singing is found to be effective and cost-effective it may offer an alternative means to maintaining the health of people in later life

Effect of a health-improvement pilot programme for older adults delivered by a professional football club: the Burton Albion case study

Older adults are a priority within policy designed to facilitate healthy lifestyles through physical activities. Golden Goal is a pilot programme of physical activity-led health improvement for older adults, 55 years and older. Activities were delivered at Burton Albion Football Club. Sessions involved weekly moderate to vigorous intensity exercise sessions including exer-gaming (exercise-orientated video-games), indoor bowls, cricket, new age curling, walking football, and traditional board games and skittles. Secondary analysis of data collected through the original programme evaluation of Golden Goal investigated the impact of the intervention on participants. Older adults completed self-reports for demographics, health screening/complications and quality of life. Attendees, n = 23 males (42.6%) and n = 31 females (57.4%) with a mean age of 69.38 (±5.87) (n = 40), ranging from 55-85 years took part. The mean attendance was 7.73 (±3.12) sessions for all participants, (n = 51). Older adults with two or more health complications (n = 22, 42.3%) attended fewer sessions on average (6.91 ± 3.322) compared to those reporting less than two health complications (8.65 ± 2.694). Self-rated health was higher for women (87.32 ± 9.573) vs. men (80.16 ± 18.557), although this was not statistically significant (U = 223.500, p = 0.350). Results support the potential of football-led health interventions for recruiting older adults, including those reporting health problems. © 2014 © 2014 Taylor & Francis

Midwives' attitudes towards giving weight-related advice to obese pregnant women

It is estimated that 1 in 5 pregnant women are obese, this poses a significant risk to maternal, fetal and newborn mortality and morbidity and as such, maternal obesity is recognised as a challenge for contemporary and prospective maternity services. As key practitioners in maternity care, midwives are seen as frontline professionals delivering weight-related advice to obese pregnant women. This study aimed to explore midwives' attitudes towards offering obese pregnant women weight-related advice during pregnancy and the puerperium. Nine midwives were interviewed using an in-depth interview schedule. Data were analysed using Colaizzi's (1978) seven-stage thematic approach. Midwives' knowledge of risk associated with maternal obesity was good; advice giving was mainly confined to community practice; the amount and consistency of advice was determined by: women's responses, women's apparent motivation to change and midwives' self-perception as a role model. Four key themes emerged: challenges for practice; perceived proficiency; advice giving skills and midwives' perceived relationship with a woman. Midwives need to address personal issues around body image, as they appear to hinder advice giving, before they can develop effective communication techniques to be able to offer obese pregnant women weight-related advice. The recommendation is to investigate ways in which issues of body image influence midwives ability to offer weight-related advice

Spiritual leadership and spiritual care in neonatology

AIM: This article aims to explore spiritual care in the neonatal care environment in addition to highlighting the importance of spiritual leadership of a health team in that context. BACKGROUND: Neonatal care is an ethically demanding and stressful area of practice. Babies and families require spiritual needs to be recognized in the context of holistic care. Literature around spiritual leadership is explored to nurture workplace spirituality. EVALUATION: Analysis of a range of sources provides a theoretical reflection on spiritual leadership and spiritual care in neonatal care settings. KEY ISSUES: The literature identifies that the carers should consider carefully on how care given may affect the infant and family. Themes relating to the baby's and family's spiritual needs and those of the staff in this area are identified. Spiritual leadership by the manager will provide support to the staff and help spiritual need to be met in this area of practice. CONCLUSION: Spiritual needs should be acknowledged within neonatal care whether these are of babies, families or the team itself. IMPLICATIONS FOR NURSING MANAGEMENT: Managers have responsibility to ensure that spiritual care is carried out for babies and their families and to care for the team as spiritual leaders