Cost-effectiveness of a Novel Hypoglycaemia Programme: The 'HARPdoc vs BGAT' RCT.

AIMS: To assess the cost-effectiveness of HARPdoc (Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes and problematic hypoglycaemia despite optimised care), focussed upon cognitions and motivation, versus BGAT (Blood Glucose Awareness Training), focussed on behaviours and education, as adjunctive treatments for treatment-resistant problematic hypoglycaemia in type 1 diabetes, in a randomised controlled trial. METHODS: Eligible adults were randomised to either intervention. Quality of life (QoL, measured using EQ-5D-5L); cost of utilisation of health services (using the adult services utilization schedule, AD-SUS) and of programme implementation and curriculum delivery were measured. A cost-utility analysis was undertaken using quality-adjusted life years (QALYs) as a measure of trial participant outcome and cost-effectiveness was evaluated with reference to the incremental net benefit (INB) of HARPdoc compared to BGAT. RESULTS: Over 24 months mean total cost per participant was £194 lower for HARPdoc compared to BGAT (95% CI: -£2498 to £1942). HARPdoc was associated with a mean incremental gain of 0.067 QALYs/participant over 24 months post-randomisation: an equivalent gain of 24 days in full health. The mean INB of HARPdoc compared to BGAT over 24 months was positive: £1521/participant, indicating comparative cost-effectiveness, with an 85% probability of correctly inferring an INB > 0. CONCLUSIONS: Addressing health cognitions in people with treatment-resistant hypoglycaemia achieved cost-effectiveness compared to an alternative approach through improved QoL and reduced need for medical services, including hospital admissions. Compared to BGAT, HARPdoc offers a cost-effective adjunct to educational and technological solutions for problematic hypoglycaemia.

What interventions should we implement in England's mental health services? The mental health implementation network (MHIN) mixed-methods approach to rapid prioritisation.

Introduction: Setting mental health priorities helps researchers, policy makers, and service funders improve mental health services. In the context of a national mental health implementation programme in England, this study aims to identify implementable evidence-based interventions in key priority areas to improve mental health service delivery. Methods: A mixed-methods research design was used for a three step prioritisation approach involving systematic scoping reviews (additional manuscript under development), expert consultations and data triangulation. Groups with diverse expertise, including experts by experience, worked together to improve decision-making quality by promoting more inclusive and comprehensive discussions. A multi-criteria decision analysis (MCDA) model was used to combine participants' varied opinions, data and judgments about the data's relevance to the issues at hand during a decision conferencing workshop where the priorities were finalised. Results: The study identified mental health interventions in three mental health priority areas: mental health inequalities, child and adolescent mental health, comorbidities with a focus on integration of mental and physical health services and mental health and substance misuse problems. Key interventions in all the priority areas are outlined. The programme is putting some of these evidence-based interventions into action nationwide in each of these three priority mental health priority areas. Conclusion: We report an inclusive attempt to ensure that the list of mental health service priorities agrees with perceived needs on the ground and focuses on evidence-based interventions. Other fields of healthcare may also benefit from this methodological approach if they need to make rapid health-prioritisation decisions.

Effectiveness and cost-effectiveness of a personalised self-management intervention for living with long COVID: protocol for the LISTEN randomised controlled trial.

BACKGROUND: Individuals living with long COVID experience multiple, interacting and fluctuating symptoms which can have a dramatic impact on daily living. The aim of the Long Covid Personalised Self-managemenT support EvaluatioN (LISTEN) trial is to evaluate effects of the LISTEN co-designed self-management support intervention for non-hospitalised people living with long COVID on participation in routine activities, social participation, emotional well-being, quality of life, fatigue, and self-efficacy. Cost-effectiveness will also be evaluated, and a detailed process evaluation carried out to understand how LISTEN is implemented. METHODS: The study is a pragmatic randomised effectiveness and cost-effectiveness trial in which a total of 558 non-hospitalised people with long COVID will be randomised to either the LISTEN intervention or usual care. Recruitment strategies have been developed with input from the LISTEN Patient and Public Involvement and Engagement (PPIE) advisory group and a social enterprise, Diversity and Ability, to ensure inclusivity. Eligible participants can self-refer into the trial via a website or be referred by long COVID services. All participants complete a range of self-reported outcome measures, online, at baseline, 6 weeks, and 3 months post randomisation (the trial primary end point). Those randomised to the LISTEN intervention are offered up to six one-to-one sessions with LISTEN-trained intervention practitioners and given a co-designed digital resource and paper-based book. A detailed process evaluation will be conducted alongside the trial to inform implementation approaches should the LISTEN intervention be found effective and cost-effective. DISCUSSION: The LISTEN trial is evaluating a co-designed, personalised self-management support intervention (the LISTEN intervention) for non-hospitalised people living with long COVID. The design has incorporated extensive strategies to minimise participant burden and maximise access. Whilst the duration of follow-up is limited, all participants are approached to consent for long-term follow-up (subject to additional funding being secured). TRIAL REGISTRATION: LISTEN ISRCTN36407216. Registered on 27/01/2022.

Study protocol: randomised controlled hybrid type 2 trial evaluating the scale-up of two arts interventions for postnatal depression and Parkinson's disease.

INTRODUCTION: Research on the benefits of 'arts' interventions to improve individuals' physical, social and psychological well-being is growing, but evidence on implementation and scale-up into health and social care systems is lacking. This protocol reports the SHAPER-Implement programme (Scale-up of Health-Arts Programmes Effectiveness-Implementation Research), aimed at studying the impact, implementation and scale-up of: Melodies for Mums (M4M), a singing intervention for postnatal depression; and Dance for Parkinson's (PD-Ballet) a dance intervention for Parkinson's disease. We examine how they could be embedded in clinical pathways to ensure their longer-term sustainability. METHODS AND ANALYSIS: A randomised two-arm effectiveness-implementation hybrid type 2 trial design will be used across M4M/PD-Ballet. We will assess the implementation in both study arms (intervention vs control), and the cost-effectiveness of implementation. The design and measures, informed by literature and previous research by the study team, were refined through stakeholder engagement. Participants (400 in M4M; 160 in PD-Ballet) will be recruited to the intervention or control group (2:1 ratio). Further implementation data will be collected from stakeholders involved in referring to, delivering or supporting M4M/PD-Ballet (N=25-30 for each intervention).A mixed-methods approach (surveys and semi-structured interviews) will be employed. 'Acceptability' (measured by the 'Acceptability Intervention Measure') is the primary implementation endpoint for M4M/PD-Ballet. Relationships between clinical and implementation outcomes, implementation strategies (eg, training) and outcomes will be explored using generalised linear mixed models. Qualitative data will assess factors affecting the acceptability, feasibility and appropriateness of M4M/PD-Ballet, implementation strategies and longer-term sustainability. Costs associated with implementation and future scale-up will be estimated. ETHICS AND DISSEMINATION: SHAPER-PND (the M4M trial) and SHAPER-PD (the PD trial) are approved by the West London and GTAC (20/PR/0813) and the HRA and Health and Care Research Wales (REC Reference: 20/WA/0261) Research Ethics Committees. Study findings will be disseminated through scientific peer-reviewed journals and scientific conferences. TRIAL REGISTRATION NUMBERS: Both trials are registered with NIH US National Library of Medicine, ClinicalTrials.gov. The trial registration numbers, URLs of registry records, and dates of registration are: (1) PD-Ballet: URL: NCT04719468 (https://eur03.safelinks.protection. OUTLOOK: com/?url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fct2%2Fshow%2FNCT04719468%3Fterm%3DNCT04719468%26draw%3D2%26rank%3D1&data=04%7C01%7Crachel.davis%40kcl.ac.uk%7C11a7c5142782437919f808d903111449%7C8370cf1416f34c16b83c724071654356%7C0%7C0%7C6375441942616) (date of registration: 22 Jan 2021). (2) Melodies for Mums: NCT04834622 (https://clinicaltrials.gov/ct2/show/NCT04834622?term=shaper-pnd&draw=2&rank=1) (date of registration: 8 Apr 2021).

HeAlth System StrEngThening in four sub-Saharan African countries (ASSET) to achieve high-quality, evidence-informed surgical, maternal and newborn, and primary care: protocol for pre-implementation phase studies.

To achieve universal health coverage, health system strengthening (HSS) is required to support the of delivery of high-quality care. The aim of the National Institute for Health Research Global Research Unit on HeAlth System StrEngThening in Sub-Saharan Africa (ASSET) is to address this need in a four-year programme, with three healthcare platforms involving eight work-packages. Key to effective health system strengthening (HSS) is the pre-implementation phase of research where efforts focus on applying participatory methods to embed the research programme within the existing health system. To conceptualise the approach, we provide an overview of the key methods applied across work-package to address this important phase of research conducted between 2017 and 2021.Work-packages are being undertaken in publicly funded health systems in rural and urban areas in Ethiopia, Sierra Leone, South Africa, and Zimbabwe. Stakeholders including patients and their caregivers, community representatives, clinicians, managers, administrators, and policymakers are the main research participants.In each work-package, initial activities engage stakeholders and build relationships to ensure co-production and ownership of HSSIs. A mixed-methods approach is then applied to understand and address determinants of high-quality care delivery. Methods such as situation analysis, cross-sectional surveys, interviews and focus group discussions are adopted to each work-package aim and context. At the end of the pre-implementation phase, findings are disseminated using focus group discussions and participatory Theory of Change workshops where stakeholders from each work package use findings to select HSSIs and develop a programme theory.ASSET places a strong emphasis of the pre-implementation phase in order to provide an in-depth and systematic diagnosis of the existing heath system functioning, needs for strengthening and stakeholder engagement. This common approach will inform the design and evaluation of the HSSIs to increase effectiveness across work packages and contexts, to better understand what works, for whom, and how.

A Health Economic Evaluation of the World Health Organization Surgical Safety Checklist: A Single Center Assessment.

OBJECTIVES: To evaluate cost-effectiveness of the WHO Surgical Safety Checklist. BACKGROUND: The clinical effectiveness of surgical checklists is largely understood. Few studies to-date have evaluated the cost-effectiveness of checklist use. METHODS: An economic evaluation was carried out using data from the only available randomized controlled trial of the checklist. Analyses were based on 3702 procedures. Costs considered included checklist implementation costs and length and cost of hospital stay, costs of warming blanket use, blood transfusions and antibiotics used in the operating room, and the cost of clinical time in the operating room - all calculated for each procedure and its associated admission. Nonparametric bootstrapping was used to simulate an empirical distribution of the mean effect of the checklist on total admission costs and the probability of observing a complication-free admission and to quantify sampling uncertainty around mean cost estimates. RESULTS: The overall cost of checklist implementation was calculated to be $900 per 100 admissions. Implementation of the WHO checklist resulted in an additional 5.9 complication-free admissions per 100 admissions and an average of 110 bed-days saved per 100 admissions. Accounting for all costs included in the analysis, for every 100 admissions, use of the WHO checklist was estimated to save $55,899. CONCLUSIONS: Implementation of the WHO checklist was a cost-effective strategy for improving surgical safety.

Economic Case for Scale-up of the WHO Surgical Safety Checklist at the National Level in Sub-Saharan Africa.

OBJECTIVES: To evaluate the economic case for nationwide scale-up of the World Health Organization (WHO) Surgical Safety Checklist using cost-effectiveness and benefit-cost analyses. BACKGROUND: The Checklist improves surgical outcomes but the economic case for widespread use remains uncertain. For perioperative quality improvement interventions to compete successfully against other worthwhile health and nonhealth interventions for limited government resources they must demonstrate cost-effectiveness and positive societal benefit. METHODS: Using data from 3 countries, we estimated the benefits as the total years of life lost (YLL) due to postoperative mortality averted over a 3 year period; converted the benefits to dollar equivalent values using estimates of the economic value of an additional year of life expectancy; estimated total implementation costs; and determined incremental cost-effectiveness ratio (ICER) and benefit-cost ratio (BCR). Costs are reported in international dollars using Word Bank purchasing power parity conversion factors at 2016 price-levels. RESULTS: In Benin, Cameroon, and Madagascar ICERs were: $31, $138, and $118 per additional YLL averted; and BCRs were 62, 29, and 9, respectively. Sensitivity analysis demonstrated that the associated mortality reduction and increased usage due to Checklist scale-up would need to deviate approximately 10-fold from published data to change our main interpretations. CONCLUSIONS: According to WHO criteria, Checklist scale-up is considered "very cost-effective" and for every $ 1 spent the potential return on investment is $9 to $62. These results compare favorably with other health and nonhealth interventions and support the economic argument for investing in Checklist scale-up as part of a national strategy for improving surgical outcomes.

Development and rapid evaluation of services to support the physical health of people using psychiatric inpatient units during the COVID-19 pandemic: study protocol.

BACKGROUND: People diagnosed with a serious mental illness have worse physical health and lower life expectancy than the general population. Integration of mental and physical health services is seen as one service development that could better support this. This protocol describes the evaluation of the provision of a Virtual Physical Health Clinic (VPHC) and Consultant Connect (CC) services to one UK-based mental health Trust. METHODS: Prospective, formative, pragmatic evaluation using both quantitative and qualitative techniques and driven by implementation science theoretical frameworks. The VPHC and CC are described along with the methodology being used to rapidly evaluate their implementation, effectiveness and potential economic impact in order to inform future roll out. We will assess the implementation process through quantitative data on uptake and reach and through self-reported data to be collected from interviews and the use of validated implementation outcome assessment measures. We will assess implementation strategies using the Expert Recommendations for Implementing Change (ERIC) strategies as a framework. We will assess the health economic impact of both services using established health economic methods including cost comparison scenarios and health service utilisation analyses. DISCUSSION: Supporting the physical health management of people in psychiatric inpatient units is important in improving the physical health of this population. Integration of mental and physical health can help this to happen effectively. This initiative provides one of the first service evaluation protocols of its kind to be reported in the UK at the time of the COVID-19 pandemic.

A multi-method evaluation of the implementation of a cancer teamwork assessment and feedback improvement programme (MDT-FIT) across a large integrated cancer system.

BACKGROUND: Globally, Multidisciplinary Teams (MDTs) are considered the gold standard for diagnosis and treatment of cancer and other conditions, but variability in performance has led to demand for improvement tools. MDT-FIT (Multidisciplinary Team Feedback for Improving Teamwork) is an improvement programme developed iteratively with over 100 MDTs (≥1100 MDT-members). Complex interventions are often adapted to context, but this is rarely evaluated. We conducted a prospective evaluation of the implementation of MDT-FIT across an entire integrated care system (ICS). METHODS: MDT-FIT was implemented within all breast cancer MDTs across an ICS in England (n = 10 MDTs; 275 medical, nursing, and administrative members). ICS managers coordinated the implementation across the three stages of MDT-FIT: set up; assessment (self-report by team members plus independent observational assessment); team-feedback and facilitated discussion to agree actions for improvement. Data were collected using process and systems logs, and interviews with a purposively selected range of participants. Analysis was theoretically grounded in evidence-based frameworks for implementation strategies and outcomes. RESULTS: All 10 MDTs participated in MDT-FIT; 36 interviews were conducted. Data from systems and process logs covered a 9-month period. Adaptations to MDT-FIT by the ICS (e.g., coordination of team participation by ICS rather than individual hospitals; and reducing time protected for coordination) reduced Fidelity and Adoption of MDT-FIT. However, the Acceptability, Appropriateness and Feasibility of MDT-FIT remained high due to embedding implementation strategies in the development of MDT-FIT (e.g., stakeholder engagement, interactive support). CONCLUSIONS: This is a unique and comprehensive evaluation of the multi-site implementation of a complex team improvement programme. Findings support the imperative of considering implementation strategies when designing such programmes to minimize potentially negative impacts of adaptations in "real world" settings.

Scoping Evidence Review on Training and Skills Assessment for Open Emergency Surgery.

OBJECTIVE: Scope evidence on technical performance metrics for open emergency surgery. Identify surgical performance metrics and procedures used in trauma training courses. DESIGN: Structured literature searches of electronic databases were conducted from January 2010 to December 2019 to identify systematic reviews of tools to measure surgical skills employed in vascular or trauma surgery evaluation and training. SETTING AND PARTICIPANTS: Faculty of Shock Trauma Anesthesiology Research Center, University of Maryland School of Medicine, Uniformed Services University of Health Sciences, Bethesda, Maryland and Implementation Science, King's College, London. RESULTS: The evidence from 21 systematic reviews including over 54,000 subjects enrolled into over 840 eligible studies, identified that the Objective Structured Assessment of Technical Skill was used for elective surgery not for emergency trauma and vascular control surgery procedures. The Individual Procedure Score (IPS), used to evaluate emergency trauma procedures performed before and after training, distinguished performance of residents from experts and practicing surgeons. IPS predicted surgeons who make critical errors and need remediation interventions. No metrics showed Kirkpatrick's Level 4 evidence of technical skills training benefit to emergency surgery outcomes. CONCLUSIONS: Expert benchmarks, errors, complication rates, task completion time, task-specific checklists, global rating scales, Objective Structured Assessment of Technical Skills, and IPS were found to identify surgeons, at all levels of seniority, who are in need of remediation of technical skills for open surgical hemorrhage control. Large-scale, multicenter studies are needed to evaluate any benefit of trauma technical skills training on patient outcomes.

How does the WHO Surgical Safety Checklist fit with existing perioperative risk management strategies? An ethnographic study across surgical specialties.

BACKGROUND: The World Health Organization (WHO) Surgical Safety Checklist (SSC) has demonstrated beneficial impacts on a range of patient- and team outcomes, though variation in SSC implementation and staff's perception of it remain challenging. Precisely how frontline personnel integrate the SSC with pre-existing perioperative clinical risk management remains underexplored - yet likely an impactful factor on how SSC is being used and its potential to improve clinical safety. This study aimed to explore how members of the multidisciplinary perioperative team integrate the SSC within their risk management strategies. METHODS: An ethnographic case study including observations (40 h) in operating theatres and in-depth interviews of 17 perioperative team members was carried out at two hospitals in 2016. Data were analysed using content analysis. RESULTS: We identified three themes reflecting the integration of the SSC in daily surgical practice: 1) Perceived usefullness; implying an intuitive advantage assessment of the SSC's practical utility in relation to relevant work; 2) Modification of implementation; reflecting performance variability of SSC on confirmation of items due to precence of team members; barriers of performance; and definition of SSC as performance indicator, and 3) Communication outside of the checklist; including formal- and informal micro-team formations where detailed, specific risk communication unfolded. CONCLUSION: When the SSC is not integrated within existing risk management strategies, but perceived as an "add on", its fidelity is compromised, hence limiting its potential clinical effectiveness. Implementation strategies for the SSC should thus integrate it as a risk-management tool and include it as part of risk-management education and training. This can improve team learning around risk comunication, foster mutual understanding of safety perspectives and enhance SSC implementation.

Patients' and healthcare workers' recommendations for a surgical patient safety checklist - a qualitative study.

BACKGROUND: Patients' involvement in patient safety has increased in healthcare. Use of checklists may improve patient outcome in surgery, though few have attempted to engage patients' use of surgical checklist. To identify risk elements of complications based on patients' and healthcare workers' experiences is warranted. This study aims to identify what the patients and healthcare workers find to be the risk elements that should be included in a patient-driven surgical patient safety checklist. METHOD: A qualitative study design where post-operative patients, surgeons, ward physicians, ward nurses, and secretaries from five surgical specialties took part in focus group interviews. Eleven focus groups were conducted including 25 post-operative patients and 27 healthcare workers at one tertiary teaching hospital and one community hospital in Norway. Based on their experiences, participants were asked to identify perceived risks before and after surgery. The interviews were analysed using content analysis. RESULTS: Safety risk factors were categorised as pre-operative information: pre-operative preparations, post-operative information, post-operative plans and follow-up. The subcategories under pre-operative information and preparations were: contact information, medication safety, health status, optimising health, dental status, read information, preparation two weeks before surgery, inform your surgical ward, planning your own discharge, preparation on admission and just before surgery. The subcategories under post-operative information, further plans and follow-up were: prevention and complications, restriction and activity, medication safety, pain relief, stomach functions, further care and appointments. Both healthcare workers and patients express the need for a surgical patient safety checklist. CONCLUSION: A broad spectre of risk elements for a patient safety checklist were identified. Developing a surgical safety checklist based on these risk elements might reduce complications and unwanted errors. TRAIL REGISTRATION: The study is registered as part of a clinical trial in ClinicalTrials.gov: NCT03105713.

Using the Knowledge to Action Framework to Describe a Nationwide Implementation of the WHO Surgical Safety Checklist in Cameroon.

BACKGROUND: Surgical safety has advanced rapidly with evidence of improved patient outcomes through structural and process interventions. However, knowledge of how to apply these interventions successfully and sustainably at scale is often lacking. The 2019 Global Ministerial Patient Safety Summit called for a focus on implementation strategies to maintain momentum in patient safety improvements, especially in low- and middle-income settings. This study uses an implementation framework, knowledge to action, to examine a model of nationwide World Health Organization (WHO) Surgical Safety Checklist implementation in Cameroon. Cameroon is a lower-middle-income country, and based on data from high- and low-income countries, we hypothesized that more than 50% of participants would be using the checklist (penetration) in the correct manner (fidelity) 4 months postintervention. METHODS: A collaboration of 3 stakeholders (Ministry of Health, academic institution, and nongovernmental organization) used a prospective observational design. Based on knowledge to action, there were 3 phases to the study implementation: problem identification (lack of routine checklist use in Cameroonian hospitals), multifaceted implementation strategy (3-day multidisciplinary training course, coaching, facilitated leadership engagement, and support networks), and outcome evaluation 4 months postintervention. Validated implementation outcomes were assessed. Primary outcomes were checklist use (penetration) and fidelity; secondary outcomes were perioperative teams' reactions, learning and behavior change; and tertiary outcomes were perioperative teams' acceptability of the checklist. RESULTS: Three hundred and fifty-one operating room staff members from 25 hospitals received training. Median time to evaluation was 4.5 months (interquartile range [IQR]: 4.5-5.5, range 3-7); checklist use (penetration) increased from 20% (95% confidence interval [CI], 16-25) to 56% (95% CI, 49-63); fidelity for adherence to 6 basic safety processes was high: verification of patient identification was 91% (95% CI, 87-95); risk assessment for difficult intubation was 79% (95% CI, 73-85): risk assessment for blood loss was 88% (95% CI, 83-93) use of pulse oximetry was 93% (95% CI, 90-97); antibiotic administration was 95% (95% CI, 91-98); surgical counting was 89% (95% CI, 84-93); and fidelity for nontechnical skills measured by the WHO Behaviorally Anchored Rating Scale was 4.5 of 7 (95% CI, 3.5-5.4). Median scores for all secondary outcomes were 10/10, and 7 acceptability measures were consistently more than 70%. CONCLUSIONS: This study shows that a multifaceted implementation strategy is associated with successful checklist implementation in a lower-middle-income country such as Cameroon, and suggests that a theoretical framework can be used to practically drive nationwide scale-up of checklist use.

Designing high-quality implementation research: development, application, feasibility and preliminary evaluation of the implementation science research development (ImpRes) tool and guide.

BACKGROUND: Designing implementation research can be a complex and daunting task, especially for applied health researchers who have not received specialist training in implementation science. We developed the Implementation Science Research Development (ImpRes) tool and supplementary guide to address this challenge and provide researchers with a systematic approach to designing implementation research. METHODS: A multi-method and multi-stage approach was employed. An international, multidisciplinary expert panel engaged in an iterative brainstorming and consensus-building process to generate core domains of the ImpRes tool, representing core implementation science principles and concepts that researchers should consider when designing implementation research. Simultaneously, an iterative process of reviewing the literature and expert input informed the development and content of the tool. Once consensus had been reached, specialist expert input was sought on involving and engaging patients/service users; and economic evaluation. ImpRes was then applied to 15 implementation and improvement science projects across the National Institute of Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) South London, a research organisation in London, UK. Researchers who applied the ImpRes tool completed an 11-item questionnaire evaluating its structure, content and usefulness. RESULTS: Consensus was reached on ten implementation science domains to be considered when designing implementation research. These include implementation theories, frameworks and models, determinants of implementation, implementation strategies, implementation outcomes and unintended consequences. Researchers who used the ImpRes tool found it useful for identifying project areas where implementation science is lacking (median 5/5, IQR 4-5) and for improving the quality of implementation research (median 4/5, IQR 4-5) and agreed that it contained the key components that should be considered when designing implementation research (median 4/5, IQR 4-4). Qualitative feedback from researchers who applied the ImpRes tool indicated that a supplementary guide was needed to facilitate use of the tool. CONCLUSIONS: We have developed a feasible and acceptable tool, and supplementary guide, to facilitate consideration and incorporation of core principles and concepts of implementation science in applied health implementation research. Future research is needed to establish whether application of the tool and guide has an effect on the quality of implementation research.

Use of health economic evaluation in the implementation and improvement science fields-a systematic literature review.

BACKGROUND: Economic evaluation can inform whether strategies designed to improve the quality of health care delivery and the uptake of evidence-based practices represent a cost-effective use of limited resources. We report a systematic review and critical appraisal of the application of health economic methods in improvement/implementation research. METHOD: A systematic literature search identified 1668 papers across the Agris, Embase, Global Health, HMIC, PsycINFO, Social Policy and Practice, MEDLINE and EconLit databases between 2004 and 2016. Abstracts were screened in Rayyan database, and key data extracted into Microsoft Excel. Evidence was critically appraised using the Quality of Health Economic Studies (QHES) framework. RESULTS: Thirty studies were included-all health economic studies that included implementation or improvement as a part of the evaluation. Studies were conducted mostly in Europe (62%) or North America (23%) and were largely hospital-based (70%). The field was split between improvement (N = 16) and implementation (N = 14) studies. The most common intervention evaluated (43%) was staffing reconfiguration, specifically changing from physician-led to nurse-led care delivery. Most studies (N = 19) were ex-post economic evaluations carried out empirically-of those, 17 were cost effectiveness analyses. We found four cost utility analyses that used economic modelling rather than empirical methods. Two cost-consequence analyses were also found. Specific implementation costs considered included costs associated with staff training in new care delivery pathways, the impacts of new processes on patient and carer costs and the costs of developing new care processes/pathways. Over half (55%) of the included studies were rated 'good' on QHES. Study quality was boosted through inclusion of appropriate comparators and reporting of incremental analysis (where relevant); and diminished through use of post-hoc subgroup analysis, limited reporting of the handling of uncertainty and justification for choice of discount rates. CONCLUSIONS: The quantity of published economic evaluations applied to the field of improvement and implementation research remains modest; however, quality is overall good. Implementation and improvement scientists should work closely with health economists to consider costs associated with improvement interventions and their associated implementation strategies. We offer a set of concrete recommendations to facilitate this endeavour.

Service user, carer and provider perspectives on integrated care for older people with frailty, and factors perceived to facilitate and hinder implementation: A systematic review and narrative synthesis.

INTRODUCTION: Older people with frailty (OPF) can experience reduced quality of care and adverse outcomes due to poorly coordinated and fragmented care, making this patient population a key target group for integrated care. This systematic review explores service user, carer and provider perspectives on integrated care for OPF, and factors perceived to facilitate and hinder implementation, to draw out implications for policy, practice and research. METHODS: Systematic review and narrative synthesis of qualitative studies identified from MEDLINE, CINAHL, PsycINFO and Social Sciences Citation Index, hand-searching of reference lists and citation tracking of included studies, and review of experts' online profiles. Quality of included studies was appraised with The Critical Appraisal Skills Programme tool for qualitative research. RESULTS: Eighteen studies were included in the synthesis. We identified four themes related to stakeholder perspectives on integrated care for OPF: different preferences for integrated care among service users, system and service organisation components, relational aspects of care and support, and stakeholder perceptions of outcomes. Service users and carers highlighted continuity of care with a professional they could trust, whereas providers emphasised improved coordination of care between providers in different care sectors as key strategies for integrated care. We identified three themes related to factors facilitating and hindering implementation: perceptions of the integrated care intervention and target population, service organisational factors and system level factors influencing implementation. Different stakeholder groups perceived the complexity of care needs of this patient population, difficulties with system navigation and access, and limited service user and carer involvement in care decisions as key factors hindering implementation. Providers mainly also highlighted other organisational and system factors perceived to facilitate and hinder implementation of integrated care for OPF. CONCLUSIONS: Similarities and differences in lay and professional stakeholder perspectives on integrated care for OPF and factors perceived to facilitate and hinder implementation were evident. Findings highlight the importance of addressing organisational and system level components of integrated care and factors influencing implementation for OPF. Greater attention needs to be placed on collaboratively involving service users, carers and providers to improve the co-design and implementation of integrated care programmes for this patient population.

A Cost-Effectiveness Analysis of Stop Smoking Interventions in Substance-Use Disorder Populations.

BACKGROUND: Tobacco smoking is highly prevalent among people attending treatment for a substance-use disorder (SUD). In the United Kingdom, specialist support to stop smoking is largely delivered by a national network of stop smoking services, and typically comprises of behavioral support delivered by trained practitioners on an individual (one-to-one) or group basis combined with a pharmacological smoking-cessation aid. We evaluate the cost-effectiveness of these interventions and compare cost-effectiveness for interventions using group- and individual-based support, in populations under treatment for SUD. METHODS: Economic modeling was used to evaluate the incremental cost-per-quality-adjusted-life-years (QALYs) gained for smoking-cessation interventions compared with alternative methods of quitting for the SUD treatment population. Allowance was made for potentially lower abstinence rates in the SUD population. RESULTS: The incremental cost-per-QALY gained from quit attempts supported through more frequently provided interventions in England ranged from around £4,700 to £12,200. These values are below the maximum cost-effectiveness threshold adopted by policy makers in England for judging whether health programs are a cost-effective use of resources. The estimated cost-per-QALY gained for interventions using group-based behavioral support were estimated to be at least half the magnitude of those using individual support due to lower intervention costs and higher reported quit rates. Conclusions reached regarding the cost-effectiveness of group-based interventions were also found to be more robust to changes in modeling assumptions. CONCLUSIONS: Smoking-cessation interventions were found to be cost-effective when applied to the SUD population, particularly when group-based behavioral support is offered alongside pharmacological treatment. IMPLICATIONS: This analysis has shown that smoking-cessation interventions combining pharmacological treatment with behavioral support can offer a cost-effective method for increasing rates of smoking cessation in populations being treated for a substance-use disorder. This is despite evidence of lower comparative success rates in terms of smoking abstinence in populations with SUD. Our evaluation suggests that medication combined with group-based behavioral support may offer better value for money in this population compared with interventions using individual support, though further evidence on the comparative effectiveness and cost of interventions delivered to SUD treatment populations would facilitate a more robust comparison.

Quality of leadership in multidisciplinary cancer tumor boards: development and evaluation of a leadership assessment instrument (ATLAS).

BACKGROUND: High-quality leadership and chairing skills are vital for good performance in multidisciplinary tumor boards (MTBs), but no instruments currently exist for assessing and improving these skills. OBJECTIVE: To construct and validate a robust instrument for assessment of MTB leading and chairing skills. DESIGN AND SETTING: We developed an observational MTB leadership assessment instrument (ATLAS). ATLAS includes 12 domains that assess the leadership and chairing skills of the MTB chairperson. ATLAS has gone through a rigorous process of refinement and content validation prior to use to assess the MTB lead by two urological surgeons (blinded to each other) in 7 real-live (n = 286 cases) and 10 video-recorded (n = 131 cases) MTBs. OUTCOME MEASURES AND STATISTICAL ANALYSIS: ATLAS domains were analyzed via descriptive statistics. Instrument content was evaluated for validity using the content validation index (CVI). Intraclass correlation coefficients (ICCs) were used to assess inter-observer reliability. RESULTS: Instrument refining resulted in ATLAS including the following 12 domains: time management, communication, encouraging contribution, ability to summarize, ensuring all patients have treatment plan, case prioritization, keeping meeting focused, facilitate discussion, conflict management, leadership, creating good working atmosphere, and recruitment for clinical trials. CVI was acceptable and inter-rater agreement adequate to high for all domains. Agreement was somewhat higher in real-time MTBs compared to video ratings. Concurrent validation evidence was derived via positive and significant correlations between ATLAS and an established validated brief MTB leadership assessment scale. CONCLUSION: ATLAS is an observational assessment instrument that can be reliably used for assessing leadership and chairing skills in cancer MTBs (both live and video-recorded). The ability to assess and feedback on team leader performance provides the ground for promotion of good practice and continuing professional development of tumor board leaders.

Improving outcomes for neonates with gastroschisis in low-income and middle-income countries: a systematic review protocol.

INTRODUCTION: There is a significant disparity in outcomes for neonates with gastroschisis in high-income countries (HICs) compared with low-income and middle-income countries (LMICs). Many LMICs report mortality rates between 75% and 100% compared with <4% in HICs. AIM: To undertake a systematic review identifying postnatal interventions associated with improved outcomes for gastroschisis in LMICs. METHODS AND ANALYSIS: Three search strings will be combined: (1) neonates; (2) gastroschisis and other gastrointestinal congenital anomalies requiring similar surgical care; (3) LMICs. Databases to be searched include MEDLINE, EMBASE, Scopus, Web of Science, ProQuest Dissertations and Thesis Global, and the Cochrane Library. Grey literature will be identified through Open-Grey, ClinicalTrials.gov, WHO International Clinical Trials Registry and ISRCTN registry (Springer Nature). Additional studies will be sought from reference lists of included studies. Study screening, selection, data extraction and assessment of methodological quality will be undertaken by two reviewers independently and team consensus sought on discrepancies. The primary outcome of interest is mortality. Secondary outcomes include complications, requirement for ventilation, parenteral nutrition duration and length of hospital stay. Tertiary outcomes include service delivery and implementation outcomes. The methodology of the studies will be appraised. Descriptive statistics and outcomes will be summarised and discussed. ETHICS AND DISSEMINATION: Ethical approval is not required since no new data are being collected. Dissemination will be via open access publication in a peer-reviewed medical journal and distribution among global health, global surgery and children's surgical collaborations and international conferences. CONCLUSION: This study will systematically review literature focused on postnatal interventions to improve outcomes from gastroschisis in LMICs. Findings can be used to help inform quality improvement projects in low-resource settings for patients with gastroschisis. In the first instance, results will be used to inform a Wellcome Trust-funded multicentre clinical interventional study aimed at improving outcomes for gastroschisis across sub-Saharan Africa. PROSPERO REGISTRATION NUMBER: CRD42018095349.