Long acting progestogens versus combined oral contraceptive pill for preventing recurrence of endometriosis related pain: the PRE-EMPT pragmatic, parallel group, open label, randomised controlled trial.

OBJECTIVES: To evaluate the clinical effectiveness of long acting progestogens compared with the combined oral contraceptive pill in preventing recurrence of endometriosis related pain. DESIGN: The PRE-EMPT (preventing recurrence of endometriosis) pragmatic, parallel group, open label, randomised controlled trial. SETTING: 34 UK hospitals. PARTICIPANTS: 405 women of reproductive age undergoing conservative surgery for endometriosis. INTERVENTIONS: Participants were randomised in a 1:1 ratio using a secure internet facility to a long acting progestogen (depot medroxyprogesterone acetate or levonorgestrel releasing intrauterine system) or the combined oral contraceptive pill. MAIN OUTCOME MEASURES: The primary outcome was pain measured three years after randomisation using the pain domain of the Endometriosis Health Profile 30 (EHP-30) questionnaire. Secondary outcomes (evaluated at six months, one, two, and three years) included the four core and six modular domains of the EHP-30, and treatment failure (further therapeutic surgery or second line medical treatment). RESULTS: 405 women were randomised to receive a long acting progestogen (n=205) or combined oral contraceptive pill (n=200). At three years, there was no difference in pain scores between the groups (adjusted mean difference -0.8, 95% confidence interval -5.7 to 4.2, P=0.76), which had improved by around 40% in both groups compared with preoperative values (an average of 24 and 23 points for long acting progestogen and combined oral contraceptive pill groups, respectively). Most of the other domains of the EHP-30 also showed improvement at all time points compared with preoperative scores, without evidence of any differences between groups. Women randomised to a long acting progestogen underwent fewer surgical procedures or second line treatments compared with those randomised to the combined oral contraceptive pill group (73 v 97; hazard ratio 0.67, 95% confidence interval 0.44 to 1.00). CONCLUSIONS: Postoperative prescription of a long acting progestogen or the combined oral contraceptive pill results in similar levels of improvement in endometriosis related pain at three years, with both groups showing around a 40% improvement compared with preoperative levels. While women can be reassured that both options are effective, the reduced risk of repeat surgery for endometriosis and hysterectomy might make long acting reversible progestogens preferable for some. TRIAL REGISTRATION: ISRCTN registry ISRCTN97865475.

Erratum to 'Exploring the cost-effectiveness of high versus low perioperative fraction of inspired oxygen in the prevention of surgical site infections among abdominal surgery patients in three low- and middle-income countries' [BJA Open 7 (2023) 100207].

[This corrects the article DOI: 10.1016/j.bjao.2023.100207.].

Erratum to "Exploring the cost-effectiveness of high versus low perioperative fraction of inspired oxygen in the prevention of surgical site infections among abdominal surgery patients in three low- and middle-income countries" [BJA Open 7 (2023) 100207].

[This corrects the article DOI: 10.1016/j.bjao.2023.100207.].

Effectiveness of Psychoeducation on Burden among Family Caregivers of Adults with Schizophrenia: A Systematic Review and Meta-Analysis.

Caring for relatives living with schizophrenia could lead to caregivers' burden. It is believed that lack of information and understanding about schizophrenia and lack of skills to cope effectively while caring for their adult relatives largely contribute to the burden they experience. The burden is assessed using assessment scales. This review aims to assess the effectiveness of psychoeducation in alleviating the burden experienced by family caregivers of adults living with schizophrenia and to identify essential factors that facilitate positive outcomes. Five databases (ASSIA, CINAHL, Embase, MEDLINE EBSCO, and PsycINFO) were systematically searched using combinations of the following key terms: "family caregivers," "schizophrenia," "burden," "psychoeducation," and "adults." Meta-analysis of included studies was conducted using RevMan 5.4. Five RCTs with 320 family caregivers were included in the review. Overall, none of the studies showed a low risk of bias. The evidence suggests that face-to-face group psychoeducation reduced family caregivers' burden when measured across different time points: one-week postintervention (mean difference -3.87 and Cl -6.06 to -1.70), six months (MD -8.76 and Cl -12.38 to -5.13), and twelve months (MD -7.38 and Cl -9.85 to -4.91). Measurements immediately after the intervention, one month, and three months postintervention when reported narratively also showed a reduction in family caregivers' burden. Face-to-face group psychoeducation provided for family caregivers effectively alleviates the burden they experience. Factors such as program content and teaching methods facilitated positive outcomes. It is recommended that psychoeducation should be integrated as a routine intervention for family caregivers.

Operationalising a Recovery-Oriented Support and Information Programme Online: The EOLAS Programme.

Evidence demonstrates that psychoeducation interventions have clinical and recovery-related benefits for people experiencing psychosis and their family members. The EOLAS programmes are one example of recovery-oriented psychoeducation programmes for psychosis. They differ from other programmes in that they are co-designed and co-facilitated (peer and clinician) group programmes. Due to the COVID-19 pandemic, EOLAS went online using a videoconferencing platform. The study examined the feasibility, acceptability and usefulness of EOLAS-Online and explored whether some of the positive recovery outcomes reported by attendees regarding the in-person programmes were replicated online. Data were collected through an online survey and semi-structured interviews. Quantitative data were analysed using descriptive statistics. Thematic analysis was used for qualitative data. Fifteen attendees (40% of attendees) completed the surveys and eight participated in interviews. A total of 80% were satisfied/very satisfied with the programme. The programme was rated highly for increased knowledge of mental health, coping strategies, and engaging with peers. The use of technology was mostly unproblematic, although some audio and video-related challenges were identified. Engaging with the online programme was experienced positively, including facilitator support to engage. The overall findings indicate that EOLAS-Online is feasible, acceptable and useful in supporting attendees' recovery journeys.

Global economic burden of unmet surgical need for appendicitis.

BACKGROUND: There is a substantial gap in provision of adequate surgical care in many low- and middle-income countries. This study aimed to identify the economic burden of unmet surgical need for the common condition of appendicitis. METHODS: Data on the incidence of appendicitis from 170 countries and two different approaches were used to estimate numbers of patients who do not receive surgery: as a fixed proportion of the total unmet surgical need per country (approach 1); and based on country income status (approach 2). Indirect costs with current levels of access and local quality, and those if quality were at the standards of high-income countries, were estimated. A human capital approach was applied, focusing on the economic burden resulting from premature death and absenteeism. RESULTS: Excess mortality was 4185 per 100 000 cases of appendicitis using approach 1 and 3448 per 100 000 using approach 2. The economic burden of continuing current levels of access and local quality was US $92 492 million using approach 1 and $73 141 million using approach 2. The economic burden of not providing surgical care to the standards of high-income countries was $95 004 million using approach 1 and $75 666 million using approach 2. The largest share of these costs resulted from premature death (97.7 per cent) and lack of access (97.0 per cent) in contrast to lack of quality. CONCLUSION: For a comparatively non-complex emergency condition such as appendicitis, increasing access to care should be prioritized. Although improving quality of care should not be neglected, increasing provision of care at current standards could reduce societal costs substantially.

Factors Influencing Attendees' Engagement with Group Psychoeducation: A Multi-stakeholder Perspective.

Few studies have explored the problem of engagement in relation to group psychoeducation from a multi-site and multi-stakeholder perspective. The aim of the study was to explore the factors influencing service user and family engagement with group psychoeducation programmes. The study design was qualitative descriptive. Data were collected through individual and focus group interviews with key stakeholders (n = 75) involved with the programme within 14 mental health sites in the Republic of Ireland. Enablers and barriers to engagement were identified at participant, provider, programme and organization level. Motivated participants and engaged clinicians, peer co-facilitation and support, and skilled and responsive facilitators were some of the factors which enhanced engagement. Barriers to engagement included readiness among participants, concerns related to stigma and confidentiality, desire to distance oneself from mental health services, a lack of support for programme participation within families, group discomfort, the time and length of the programme, issues with transport, visibility of the programme, and structural supports for clinicians. Findings from the study illustrate the multifaceted nature of engagement as well as provide a greater understanding of the multifactorial influences on engagement. Strategies to enhance engagement should therefore reflect a multipronged approach. At the outset of programme implementation, organizations should address their readiness to engage, conduct local needs assessments to anticipate individuals' needs and plan accordingly in order to maximize engagement, and bolster facilitators' engagement skills through the provision of training and mentoring opportunities.

Family members' perspectives on the acceptability and impact of a co-facilitated information programme: the EOLAS mental health programme.

BACKGROUND: Despite the critical role families play in the care and recovery journeys of people who experience enduring mental distress, they are often excluded by the mental health services in the care and decision-making process. International trends in mental health services emphasise promoting a partnership approach between service users, families and practitioners within an ethos of recovery. OBJECTIVE: This paper evaluated the acceptability of and initial outcomes from a clinician and peer co-led family information programme. METHODS: A sequential design was used involving a pre-post survey to assess changes in knowledge, confidence, advocacy, recovery and hope following programme participation and interviews with programme participants. Participants were recruited from mental health services running the information programme. In all, 86 participants completed both pre- and post-surveys, and 15 individuals consented to interviews. RESULTS: Survey findings indicated a statistically significant change in family members' knowledge about mental health issues, recovery attitudes, sense of hope and confidence. In addition, the interviews suggested that the programme had a number of other positive outcomes for family members, including increased communication with members of the mental health team and increased awareness of communication patterns within the family unit. Family members valued the opportunity to share their experiences in a 'safe' place, learn from each other and provide mutual support. CONCLUSION: The evaluation highlights the importance of developing information programmes in collaboration with family members as well as the strength of a programme that is jointly facilitated by a family member and clinician.

Scoping review of factors influencing the implementation of group psychoeducational initiatives for people experiencing mental health difficulties and their families.

BACKGROUND: Despite evidence to support the effectiveness of psychoeducation for people experiencing mental health difficulties and their families, understanding issues around the implementation of such programmes is limited. AIM: The aim of this scoping review was to synthesise the peer-reviewed literature on barriers and enablers influencing the implementation of group psychoeducation in adult mental health services. METHODS: Using a pre-defined search strategy and PRISMA guidelines, four databases were systematically searched. Two reviewers independently screened and applied exclusion/inclusion criteria. Qualitative, quantitative, and mixed-methods studies were included if they provided empirical evidence on the barriers and enablers. Three reviewers independently extracted data. Following this, data were analysed using a five-level implementation framework. RESULTS: Eight articles met the inclusion criteria. Barriers to implementation were identified at all five levels of the framework: participant; practitioner; intervention; organisational; and structural level. Enablers to implementation were evident at four levels: participant; provider; intervention; and organisational level. CONCLUSIONS: The findings of the review provide preliminary information on factors that impact implementation. However, large-scale studies informed by implementation theories are required. In addition, other studies are needed to address the potential impact of different models of intervention and explore strategies to minimize obstacles and support sustainability.

Preliminary model assessing the cost-effectiveness of preoperative chlorhexidine mouthwash at reducing postoperative pneumonia among abdominal surgery patients in South Africa.

BACKGROUND: Pneumonia is a common and severe complication of abdominal surgery, it is associated with increased length of hospital stay, healthcare costs, and mortality. Further, pulmonary complication rates have risen during the SARS-CoV-2 pandemic. This study explored the potential cost-effectiveness of administering preoperative chlorhexidine mouthwash versus no-mouthwash at reducing postoperative pneumonia among abdominal surgery patients. METHODS: A decision analytic model taking the South African healthcare provider perspective was constructed to compare costs and benefits of mouthwash versus no-mouthwash-surgery at 30 days after abdominal surgery. We assumed two scenarios: (i) the absence of COVID-19; (ii) the presence of COVID-19. Input parameters were collected from published literature including prospective cohort studies and expert opinion. Effectiveness was measured as proportion of pneumonia patients. Deterministic and probabilistic sensitivity analyses were performed to assess the impact of parameter uncertainties. The results of the probabilistic sensitivity analysis were presented using cost-effectiveness planes and cost-effectiveness acceptability curves. RESULTS: In the absence of COVID-19, mouthwash had lower average costs compared to no-mouthwash-surgery, $3,675 (R 63,770) versus $3,958 (R 68,683), and lower proportion of pneumonia patients, 0.029 versus 0.042 (dominance of mouthwash intervention). In the presence of COVID-19, the increase in pneumonia rate due to COVID-19, made mouthwash more dominant as it was more beneficial to reduce pneumonia patients through administering mouthwash. The cost-effectiveness acceptability curves shown that mouthwash surgery is likely to be cost-effective between $0 (R0) and $15,000 (R 260,220) willingness to pay thresholds. CONCLUSIONS: Both the absence and presence of SARS-CoV-2, mouthwash is likely to be cost saving intervention for reducing pneumonia after abdominal surgery. However, the available evidence for the effectiveness of mouthwash was extrapolated from cardiac surgery; there is now an urgent need for a robust clinical trial on the intervention on non-cardiac surgery.

Community engagement and involvement in Ghana: conversations with community stakeholders to inform surgical research.

BACKGROUND: Involving patients and communities with health research in low- and middle-income countries (LMICs) contributes to increasing the likelihood that research is relevant in local context and caters to the needs of the population, including vulnerable and marginalised groups. When done right, it can also support empowerment of wider communities in taking ownership of their own health, lead to increased access and uptake of health services and generally improve the wellbeing of individuals. However, the evidence base of how to undertake successful community engagement and involvement (CEI) activities in LMICs is sparse. This paper aims to add to the available literature and describes how the Global Health Research Unit on Global Surgery's (GSU) team in Ghana worked collaboratively with the Unit's team in the UK and a UK-based Public Advisory Group to involve community stakeholders in rural Ghana with surgical research. The aim was to explore ways of reaching out to patients and community leaders in rural Ghana to have conversations that inform the relevance, acceptability, and feasibility of a clinical trial, called TIGER. METHODS: As this kind of larger scale involvement of community stakeholders with research was a novel way of working for the team in Ghana, a reflective approach was taken to outline step-by-step how the GSU team planned and undertook these involvement activities with 31 hernia patients, two Chiefs (community leaders), a community finance officer and a local politician in various locations in Ghana. The barriers that were experienced and the benefits of involving community stakeholders are highlighted with the aim to add to the evidence base of CEI in LMICs. RESULTS: GSU members from the UK and Ghana planned and organised successful involvement activities that focused on establishing the best way to talk to patients and other community stakeholders about their experiences of living with hernias and undergoing hernia repairs, and their perceptions of the impact of hernias on the wider community. The Ghanaian team suggested 1:1 conversations in easily accessible locations for rural patient contributors, creating a welcoming environment and addressing contributors in their local dialects. A UK-based Public Advisory Group helped in the initial stages of planning these conversations by highlighting potential barriers when approaching rural communities and advising on how to phrase questions around personal experiences. Conversations mainly focused on understanding the needs of hernia patients in rural Ghana to then incorporate these in the design of the TIGER trial to ensure its relevance, acceptability and feasibility. When talking to patient contributors, the GSU teams found that they were more likely to open up when they knew members of the team and the opportunity to speak to local leaders only arose because of the Ghanaian team members being well-respected amongst communities. The experiences of the patient and community contributors led to changes in the study protocol, such as including women in the patient cohort for the trial, and allowed the GSU teams to confirm the relevance and acceptability of this trial. These conversations also taught the team a lot about perceptions of health in rural communities, allowed the Ghanaian team to establish relationships with community leaders that can be utilised when future studies need input from the public, and has changed the minds of the Ghanaian research team about the importance of involving patients with research. CONCLUSION: This paper contributes to the evidence base on successful CEI activities in LMICs by providing an example of how CEI can be planned and organised, and the benefits this provides. The conversations the teams had with patient contributors in Ghana are an example of successful patient consultations. Even though there are certain limitations to the extent of these involvement activities, a solid foundation has been built for researchers and community stakeholders to establish relationships for ongoing involvement.

Evidence in the literature shows that research that was designed and implemented with the help of patients or other members of the community affected by the study, is more likely to be relevant to the needs of the end user. This can have positive effects on the quality and impact of the study. However, working collaboratively with patient or public contributors can have certain challenges, especially in low- and middle- income countries. For example, factors such as different languages or dialects, religious beliefs, health beliefs, level of literacy, understanding of research, and poverty can potentially make it more difficult for researchers to reach, communicate and involve relevant members of the public. On top of this, the evidence base for successfully implementing these so-called community engagement and involvement activities is sparse, making it more challenging for researchers to learn from others' experiences.Members of the Global Surgery Unit, who are based in Ghana, proposed a clinical trial to address the shortfall of specialist surgeons at rural hospitals. This will be achieved by training medically qualified doctors, who have not yet gone through the specialist training to become qualified surgeons, to perform inguinal hernia repairs proficiently. Before the study gets funded and a protocol can be designed, the researchers need to ensure its relevance, acceptability, and feasibility. This is usually done by getting the opinion and thoughts of key stakeholders, mainly individuals who will be affected by the research. To achieve this, the team in Ghana worked together with Global Surgery Unit members in the UK to identify the best ways to approach and have conversations with 31 inguinal hernia patients who either previously had surgery or currently live with hernias, two Chiefs (community leaders), a community finance officer and a local politician in a variety of locations in Ghana that are representative of the patient cohort for the study. The intention was to understand the impact of hernias on individual patients, their families, and entire communities to inform the relevance, acceptability and feasibility of the clinical trial, and ensure that relevant aspects are captured in the study protocol. A UK-based public advisory group provided initial input to help eliminate potential barriers of addressing patient contributors in rural Ghana.This paper states in detail how these conversations were planned and organised, the challenges the team had to overcome, and what they learned and gained from talking to community members - which goes far beyond just informing a study.

Financial health and obesity.

We use individual-level panel data from the English Longitudinal Survey of Ageing over the period 2004-2013 to investigate the links between financial health and obesity. We find that having no debt (high savings) is associated with a 3.6 (1.6) percentage point lower probability of having a Body Mass Index in excess of 30. Our results are robust to using different estimation methods, to measuring financial health with a subjective indicator, and adiposity with waist circumference. A lower rate of time preference and lower stress levels may be mechanisms which help to explain the association between good financial health and obesity.

"The Road We Travel": Developing a co-produced narrative for a photovoice project.

WHAT IS KNOWN ON THE SUBJECT?: PhotoVoice as a participatory methodology has been used within mental health to support marginalized communities in addressing the challenges they encounter. The PhotoVoice methodology aims to encourage and foster collaborative and equal partnerships. However, reports of previous projects highlight that not every stage of the process remains participant-centric. There is limited reporting on participant involvement in the latter stages of projects, such as exhibition design. WHAT THE PAPER ADDS TO EXISTING KNOWLEDGE?: It provides a detailed description of the phases involved in planning and executing a mental health PhotoVoice project. It provides an illustration of how collaborative partnerships can extend into the design and construction of a photography exhibition and its narrative. WHAT ARE THE IMPLICATIONS FOR PRACTICE?: PhotoVoice is an ideal methodology for use within the field of mental health nursing as it promotes service user inclusion in research, places value on lived experiences and provides a creative medium through which service users and family members can advocate for themselves and others. PhotoVoice is an effective and creative methodology for disseminating and communicating both the individual and collective outcomes to the general public. When implementing this methodology, clinicians and researchers need to be cognisant of the necessity to include participants as equal partners at every stage, including in the design of photography exhibitions and disseminating the findings to academic and public audiences. ABSTRACT: Introduction PhotoVoice is a participatory methodology in which marginalized communities represent their lived experiences through photography. While the methodology aims to foster partnerships throughout all phases, the literature suggests that in the field of mental health, some phases are often completed without participant involvement. Aims This paper elaborates on how the PhotoVoice method was used to engage service users and family members around their experience of involvement in a co-produced and co-facilitated mental health education intervention, in order to enhance public and policymakers knowledge of the project. Methods Ten participants were recruited and trained in the PhotoVoice method. Participants documented, through photography, their experiences of involvement in the education intervention. Following this, participants came together to co-produce and disseminate the photography exhibition to the public. Results PhotoVoice proved to be a flexible and creative method by which to include marginalized groups. By adhering to the collaborative principles of the methodology, service users and family members can retain decision-making power from the project's inception to its conclusion. Implications for Practice PhotoVoice is ideal for use within mental health nursing as it coincides with the recovery principle of promoting collaborative partnership between service users, family members and clinicians. Mental health nurses work directly with service users and family members throughout their recovery journey. The PhotoVoice methodology is coherent with the recovery principles of empowerment, collaboration and prioritizing the lived experiences of the individual. As such, this methodology has the potential to enhance greatly what mental health nurses can know and understand about the lived experiences of service users and family members. In turn, engaging with the PhotoVoice methodology can provide a platform from which further collaborative engagement between service users, family members and clinicians can take place.

Factors impacting the implementation of a psychoeducation intervention within the mental health system: a multisite study using the consolidation framework for implementation research.

BACKGROUND: Despite a strong evidence base and policy recommendation supporting the implementation of psychoeducation interventions within the mental health system, equitable access for many service users and family members has not been achieved. To enhance translation, developing an evidence-base around the factors that influence implementation of interventions is critical. METHODS: The aim of the study was to explore the factors influencing implementation of a group cofacilitated recovery focused psychoeducation intervention. The study design was explorative qualitative descriptive, involving the collection of data through individual and focus group interviews with key stakeholders (n = 75) involved with the implementation within 14 mental health sites in the Republic of Ireland. The Consolidation Framework for Implementation Research (CFIR) was used as a conceptual framework to guide data collection and analysis. RESULTS: Key enablers and barriers were identified across all CFIR domains of the framework with some factors (depending on context) being both an enabler and a barrier. Important factors in the outer setting domain included structural stability within national systems and the peer payment system, while the extent of a recovery-oriented culture, leadership, implementation readiness, and buy-in were influential factors in the inner setting. The characteristics of the intervention in terms of design, evidence-base and adaptability also shaped the intervention's implementation as did the knowledge, beliefs and self-efficacy of facilitators. In terms of processes, implementation was influenced by the degree of engagement of key individuals who championed and supported the programme. The results highlight that while some of the barriers were specific to the programme, many reflected systemic and structural challenges within health services more generally. CONCLUSION: Findings from this study provide an enhanced understanding of the different layers of determinants to implementation of an intervention. Overcoming challenges will involve positive and ongoing engagement and collaboration across the full range of stakeholders that are active within each domain, including policy and operational levels. The quality of leadership at each domain level is of crucial importance to successful implementation.

Surgical site infection and costs in low- and middle-income countries: A systematic review of the economic burden.

BACKGROUND: Surgical site infection (SSI) is a worldwide problem which has morbidity, mortality and financial consequences. The incidence rate of SSI is high in Low- and Middle-Income countries (LMICs) compared to high income countries, and the costly surgical complication can raise the potential risk of financial catastrophe. OBJECTIVE: The aim of the study is to critically appraise studies on the cost of SSI in a range of LMIC studies and compare these estimates with a reference standard of high income European studies who have explored similar SSI costs. METHODS: A systematic review was undertaken using searches of two electronic databases, EMBASE and MEDLINE In-Process & Other Non-Indexed Citations, up to February 2019. Study characteristics, comparator group, methods and results were extracted by using a standard template. RESULTS: Studies from 15 LMIC and 16 European countries were identified and reviewed in full. The additional cost of SSI range (presented in 2017 international dollars) was similar in the LMIC ($174-$29,610) and European countries ($21-$34,000). Huge study design heterogeneity was encountered across the two settings. DISCUSSION: SSIs were revealed to have a significant cost burden in both LMICs and High Income Countries in Europe. The magnitude of the costs depends on the SSI definition used, severity of SSI, patient population, choice of comparator, hospital setting, and cost items included. Differences in study design affected the comparability across studies. There is need for multicentre studies with standardized data collection methods to capture relevant costs and consequences of the infection across income settings.

Beyond the moment: Influence of a co-facilitated education intervention on practitioners' recovery beliefs and practices.

Despite health policy and research increasingly advocating for recovery-enabling principles to be better integrated into mental health services, finding solutions to enhance the translation of recovery policy into practice remains a challenge. This study sought to understand whether a co-facilitated group education intervention for service users and family members reached beyond the intervention and impacted the everyday recovery promoting beliefs and practices of the practitioners involved and the wider organization. The study employed a qualitative design involving semi-structured interviews with a purposively selected sample of 28 participants (mental health nurses and other members of the multidisciplinary team) who were involved in delivering the intervention. Data were analysed using thematic analysis, with the assistance of NVivo. Participants reported that not only did involvement with the programmes help them reconnect with the contextual realities of service user and family members lived experience, but it enabled them to move beyond traditional power relationships and pathologizing discourses. Having engaged with and experienced the feasibility and positive impact of the co-facilitation process practitioners' self-efficacy around partnership working and co-production was enhanced. In addition, those involved demonstrated a willingness to challenge paternalistic practices and advocate for the perspectives of service users and families to be further embedded within the organizational infrastructure and operational spaces. Providing mental health practitioners with real-life examples of partnership working and peer support in action within a co-facilitated psychoeducation context has potential to be a forum for promoting second-order change around recovery-oriented practice within mental health services.

Economic evaluation alongside the Speed of Increasing milk Feeds Trial (SIFT).

OBJECTIVE: To evaluate the cost-effectiveness of two rates of enteral feed advancement (18 vs 30 mL/kg/day) in very preterm and very low birth weight infants. DESIGN: Within-trial economic evaluation alongside a multicentre, two-arm parallel group, randomised controlled trial (Speed of Increasing milk Feeds Trial). SETTING: 55 UK neonatal units from May 2013 to June 2015. PATIENTS: Infants born <32 weeks' gestation or <1500 g, receiving less than 30 mL/kg/day of milk at trial enrolment. Infants with a known severe congenital anomaly, no realistic chance of survival, or unlikely to be traceable for follow-up, were ineligible. INTERVENTIONS: When clinicians were ready to start advancing feed volumes, infants were randomised to receive daily increments in feed volume of 30 mL/kg (intervention) or 18 mL/kg (control). MAIN OUTCOME MEASURE: Cost per additional survivor without moderate to severe neurodevelopmental disability at 24 months of age corrected for prematurity. RESULTS: Average costs per infant were slightly higher for faster feeds compared with slower feeds (mean difference £267, 95% CI -6928 to 8117). Fewer infants achieved the principal outcome of survival without moderate to severe neurodevelopmental disability at 24 months in the faster feeds arm (802/1224 vs 848/1246). The stochastic cost-effectiveness analysis showed a likelihood of worse outcomes for faster feeds compared with slower feeds. CONCLUSIONS: The stochastic cost-effectiveness analysis shows faster feeds are broadly equivalent on cost grounds. However, in terms of outcomes at 24 months age (corrected for prematurity), faster feeds are harmful. Faster feeds should not be recommended on either cost or effectiveness grounds to achieve the primary outcome.

Two speeds of increasing milk feeds for very preterm or very low-birthweight infants: the SIFT RCT.

BACKGROUND: Observational data suggest that slowly advancing enteral feeds in preterm infants may reduce necrotising enterocolitis but increase late-onset sepsis. The Speed of Increasing milk Feeds Trial (SIFT) compared two rates of feed advancement. OBJECTIVE: To determine if faster (30 ml/kg/day) or slower (18 ml/kg/day) daily feed increments improve survival without moderate or severe disability and other morbidities in very preterm or very low-birthweight infants. DESIGN: This was a multicentre, two-arm, parallel-group, randomised controlled trial. Randomisation was via a web-hosted minimisation algorithm. It was not possible to safely and completely blind caregivers and parents. SETTING: The setting was 55 UK neonatal units, from May 2013 to June 2015. PARTICIPANTS: The participants were infants born at < 32 weeks' gestation or a weight of < 1500 g, who were receiving < 30 ml/kg/day of milk at trial enrolment. INTERVENTIONS: When clinicians were ready to start advancing feed volumes, the infant was randomised to receive daily feed increments of either 30 ml/kg/day or 18 ml/kg/day. In total, 1400 infants were allocated to fast feeds and 1404 infants were allocated to slow feeds. MAIN OUTCOME MEASURES: The primary outcome was survival without moderate or severe neurodevelopmental disability at 24 months of age, corrected for gestational age. The secondary outcomes were mortality; moderate or severe neurodevelopmental disability at 24 months corrected for gestational age; death before discharge home; microbiologically confirmed or clinically suspected late-onset sepsis; necrotising enterocolitis (Bell's stage 2 or 3); time taken to reach full milk feeds (tolerating 150 ml/kg/day for 3 consecutive days); growth from birth to discharge; duration of parenteral feeding; time in intensive care; duration of hospital stay; diagnosis of cerebral palsy by a doctor or other health professional; and individual components of the definition of moderate or severe neurodevelopmental disability. RESULTS: The results showed that survival without moderate or severe neurodevelopmental disability at 24 months occurred in 802 out of 1224 (65.5%) infants allocated to faster increments and 848 out of 1246 (68.1%) infants allocated to slower increments (adjusted risk ratio 0.96, 95% confidence interval 0.92 to 1.01). There was no significant difference between groups in the risk of the individual components of the primary outcome or in the important hospital outcomes: late-onset sepsis (adjusted risk ratio 0.96, 95% confidence interval 0.86 to 1.07) or necrotising enterocolitis (adjusted risk ratio 0.88, 95% confidence interval 0.68 to 1.16). Cost-consequence analysis showed that the faster feed increment rate was less costly but also less effective than the slower rate in terms of achieving the primary outcome, so was therefore found to not be cost-effective. Four unexpected serious adverse events were reported, two in each group. None was assessed as being causally related to the intervention. LIMITATIONS: The study could not be blinded, so care may have been affected by knowledge of allocation. Although well powered for comparisons of all infants, subgroup comparisons were underpowered. CONCLUSIONS: No clear advantage was identified for the important outcomes in very preterm or very low-birthweight infants when milk feeds were advanced in daily volume increments of 30 ml/kg/day or 18 ml/kg/day. In terms of future work, the interaction of different milk types with increments merits further examination, as may different increments in infants at the extremes of gestation or birthweight. TRIAL REGISTRATION: Current Controlled Trials ISRCTN76463425. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 18. See the NIHR Journals Library website for further project information.

Some infants who are born early need to be fed through a tube into their stomach. A small volume of milk is given to begin with, which is gradually increased. To determine whether infants do better if they are fed faster or slower, this study compared increasing the milk feeds by 30 ml/kg/day with increasing the milk feeds by 18 ml/kg/day, aiming to get to full feeds (when other fluids are not needed) in 5 or 9 days. We compared results from the two groups at discharge from hospital and at 24 months of age, after correcting for prematurity. We also assessed the economic impact of the two daily feed increments, interviewed parents about taking part in multiple studies and tested methods for improving questionnaire returns. The faster-fed group reached full milk feeds sooner and needed less intravenous nutrition, and the proportion of infants developing bowel inflammation or bloodstream infection were similar. At 24 months of age, we found an unexpected increase in the risk of moderate or severe motor impairment in the faster-fed group, which is difficult to explain. We also saw that other types of disability were more frequent in the faster group, although this was not significantly different mathematically. This means that no clear advantage of increasing feeds at faster or slower rates was identified and health professionals will need to carefully consider how to increase feeds. After accepting the increased risk of disability, an economic evaluation showed that increasing milk feed volumes at a faster rate was not a cost-effective strategy. Interviews with parents showed that they valued opportunities for their infant to take part in studies, but this interaction is complex and difficult to remember at a stressful and confusing time and made worse by considering multiple studies. More questionnaires were returned when vouchers were given before rather than after receiving them.

Mixed-methods feasibility study of blood pressure self-screening for hypertension detection.

OBJECTIVE: To assess the feasibility of using a blood pressure (BP) self-measurement kiosk-a solid-cuff sphygmomanometer combined with technology to integrate the BP readings into patient electronic medical records- to improve hypertension detection. DESIGN: A concurrent mixed-methods feasibility study incorporating observational and qualitative interview components. SETTING: Two English general practitioner (GP) surgeries. PARTICIPANTS: Adult patients registered at participating surgeries. Staff working at these sites. INTERVENTIONS: BP self-measurement kiosks were placed in the waiting rooms for a 12-month period between 2015 and 2016 and compared with a 12-month control period prior to installation. OUTCOME MEASURES: (1) The number of patients using the kiosk and agreeing to transfer of their data into their electronic medical records; (2) the cost of using a kiosk compared with GP/practice nurse BP screening; (3) qualitative themes regarding use of the equipment. RESULTS: Out of 15 624 eligible patients, only 186 (1.2%, 95% CI 1.0% to 1.4%) successfully used the kiosk to directly transfer a BP reading into their medical record. For a considerable portion of the intervention period, no readings were transferred, possibly indicating technical problems with the transfer link. A comparison of costs suggests that at least 52.6% of eligible patients would need to self-screen in order to bring costs below that of screening by GPs and practice nurses. Qualitative interviews confirmed that both patients and staff experienced technical difficulties, and used alternative methods to enter BP results into the medical record. CONCLUSIONS: While interviewees were generally positive about checking BP in the waiting room, the electronic transfer system as tested was neither robust, effective nor likely to be a cost-effective approach, thus may not be appropriate for a primary care environment. Since most of the cost of a kiosk system lies in the transfer mechanism, a solid-cuff sphygmomanometer and manual entry of results may be a suitable alternative.

Cost-Effectiveness of Telemonitoring and Self-Monitoring of Blood Pressure for Antihypertensive Titration in Primary Care (TASMINH4).

The use of self-monitoring of blood pressure, with or without telemonitoring, to guide therapy decisions by physicians for patients with hypertension has been recently demonstrated to reduce blood pressure compared with using clinic monitoring (usual care). However, both the cost-effectiveness of these strategies compared with usual care, and whether the additional benefit of telemonitoring compared with self-monitoring alone could be considered value for money, are unknown. This study assessed the cost-effectiveness of physician titration of antihypertensive medication using self-monitored blood pressure, with or without telemonitoring, to make hypertension treatment decisions in primary care compared with usual care. A Markov patient-level simulation model was developed taking a UK Health Service/Personal Social Services perspective. The model adopted a lifetime time horizon with 6-month time cycles. At a willingness to pay of £20 000 per quality-adjusted life year, self-monitoring plus telemonitoring was the most cost-effective strategy (£17 424 per quality-adjusted life year gained) compared with usual care or self-monitoring alone (posting the results to the physician). However, deterministic sensitivity analysis showed that self-monitoring alone became the most cost-effective option when changing key assumptions around long-term effectiveness and time horizon. Overall, probabilistic sensitivity analysis suggested that self-monitoring regardless of transmission modality was likely to be cost-effective compared with usual care (89% probability of cost-effectiveness at £20 000/quality-adjusted life year), with high uncertainty as to whether telemonitoring or self-monitoring alone was the most cost-effective option. Self-monitoring in clinical practice is cost-effective and likely to lead to reduced cardiovascular mortality and morbidity.