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

Geographically extensive larval surveys reveal an unexpected scarcity of primary vector mosquitoes in a region of persistent malaria transmission in western Zambia

Background The Barotse floodplains of the upper Zambezi River and its tributaries are a highly dynamic environment, with seasonal flooding and transhumance presenting a shifting mosaic of potential larval habitat and human and livestock bloodmeals for malaria vector mosquitoes. However, limited entomological surveillance has been undertaken to characterise the vector community in these floodplains and their environs. Such information is necessary as, despite substantial deployment of insecticide-treated nets (ITNs) and indoor residual spraying (IRS) against Anopheles vectors, malaria transmission persists across Barotseland in Zambia’s Western Province. Methods Geographically extensive larval surveys were undertaken in two health districts along 102 km of transects, at fine spatial resolution, during a dry season and following the peak of the successive wet season. Larvae were sampled within typical Anopheles flight range of human settlements and identified through genetic sequencing of cytochrome c oxidase I and internal transcribed spacer 2 regions of mitochondrial and nuclear DNA. This facilitated detailed comparison of taxon-specific abundance patterns between ecological zones differentiated by hydrological controls. Results An unexpected paucity of primary vectors was revealed, with An. gambiae s.l. and An. funestus representing <2% of 995 sequenced anophelines. Potential secondary vectors predominated in the vector community, primarily An. coustani group species and An squamosus. Whilst the distribution of An. gambiae s.l. in the study area was highly clustered, secondary vector species were ubiquitous across the landscape in both dry and wet seasons, with some taxon-specific relationships between abundance and ecological zones by season. Conclusions The diversity of candidate vector species and their high relative abundance observed across diverse hydro-ecosystems indicates a highly adaptable transmission system, resilient to environmental variation and, potentially, interventions that target only part of the vector community. Larval survey results imply that residual transmission of malaria in Barotseland is being mediated predominantly by secondary vector species, whose known tendencies for crepuscular and outdoor biting renders them largely insensitive to prevalent vector control methods

Evaluation of a community-based performance arts programme for people who have experienced stroke in the UK: protocol for the SHAPER-Stroke Odysseys study

INTRODUCTION: Stroke survivors, once in the community, face challenges with their long-term rehabilitation care and present higher levels of loneliness, depression and anxiety than the rest of the population. A community-based performance arts programme, Stroke Odysseys (SO), has been devised to tackle the challenges of living with stroke in the UK. In this study, we aim to evaluate the implementation, impact and experiences of SO for stroke survivors. METHODS AND ANALYSIS: Scaling-up Health Arts Programmes: Implementation and Effectiveness Research (SHAPER)-SO aims to scale-up SO to 75 participants and 47 stakeholders, while simultaneously evaluating the effectiveness and implementation of the programme. The main research aim is to evaluate the implementation, effectiveness, impact and experiences of a community-based performance arts programme (SO for stroke survivors). This mixed-methods study will evaluate the experience and impact of SO on those participating using mixed methods (interviews, observations and surveys) before and after each stage and carry out non-participant observations during a percentage of the workshops, training and tour. Data will be analysed using quantitative and qualitative approaches. This is a study within the SHAPER programme. ETHICS AND DISSEMINATION: Ethical approval has been granted by the King's College London PNM Research Ethics Panel, REC reference: LRS/DP-20/21-21549. Written informed consent will be sought for participants and stakeholders. The results of the study will be reported and disseminated at international conferences and in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NCT04864470

Optimising implementation strategies of the first scaleup of a primary care psychological intervention for common mental disorders in Sub-Saharan Africa: a mixed methods study protocol for the optimised Friendship Bench (OptFB)

Introduction Common mental disorders (CMDs) are a leading cause of disability globally. CMDs are highly prevalent in Zimbabwe and have been addressed by an evidence-based, task-shifting psychological intervention called the Friendship Bench (FB). The task-shifted FB programme guides clients through problem-solving therapy. It was scaled up across 36 implementation sites in Zimbabwe in 2016. Methods and analysis This study will employ a mixed-method framework. It aims to: (1) use quantitative survey methodologies organised around the Reach, Effectiveness, Adoption and Implementation and Maintenance evaluation framework to assess the current scaleup of the FB intervention and classify 36 clinics according to levels of performance; (2) use qualitative focus group discussions and semistructured interviews organised around the Consolidated Framework for Implementation Research to analyse determinants of implementation success, as well as elucidate heterogeneity in implementation strategies through comparing high-performing and low-performing clinics; and (3) use the results from aims 1 and 2 to develop strategies to optimise the Friendship Bench intervention and apply this model in a cluster randomised controlled trial to evaluate potential improvements among low-performing clinics. The trial will be registered with the Pan African Clinical Trial Registry (www.pactr.org). The planned randomised controlled trial for the third research aim will be registered after completing aims one and two because the intervention is dependent on knowledge generated during these phases. Ethics and dissemination The research protocol received full authorisation from the Medical Research Council of Zimbabwe (MRCZ A/242). It is anticipated that changes in data collection tools and consent forms will take place at all three phases of the study and approval from MRCZ will be sought. All interview partners will be asked for informed consent. The research team will prioritise open-access publications to disseminate research results

Development and psychometric evaluation of the Implementation Science Research Project Appraisal Criteria (ImpResPAC) tool: a study protocol

Introduction: The need for quantitative criteria to appraise the quality of implementation research has recently been highlighted to improve methodological rigour. The Implementation Science Research development (ImpRes) tool and supplementary guide provide methodological guidance and recommendations on how to design high-quality implementation research. This protocol reports on the development of the Implementation Science Research Project Appraisal Criteria (ImpResPAC) tool, a quantitative appraisal tool, developed based on the structure and content of the ImpRes tool and supplementary guide, to evaluate the conceptual and methodological quality of implementation research. Methods and analysis: This study employs a three-stage sequential mixed-methods design. During stage 1, the research team will map core domains of the ImpRes tool, guidance and recommendations contained in the supplementary guide and within the literature, to ImpResPAC. In stage 2, an international multidisciplinary expert group, recruited through purposive sampling, will inform the refinement of ImpResPAC, including content, scoring system and user instructions. In stage 3, an extensive psychometric evaluation of ImpResPAC, that was created in stage 1 and refined in stage 2, will be conducted. The scaling assumptions (inter-item and item-total correlations), reliability (internal consistency, inter-rater) and validity (construct and convergent validity) will be investigated by applying ImpResPAC to 50 protocols published in Implementation Science. We envisage developing ImpResPAC in this way will provide implementation research stakeholders, primarily grant reviewers and educators, a comprehensive, transparent and fair appraisal of the conceptual and methodological quality of implementation research, increasing the likelihood of funding research that will generate knowledge and contribute to the advancement of the field. Ethics and dissemination: This study will involve human participants. This study has been registered and minimal risk ethical clearance granted by The Research Ethics Office, King’s College London (reference number MRA-20/21-20807). Participants will receive written information on the study via email and will provide e-consent if they wish to participate. We will use traditional academic modalities of dissemination (eg, conferences and publications)

Using the RE-AIM framework to evaluate the implementation of scaling-up the Friendship Bench in Zimbabwe - a quantitative observational study

Background: This study aimed to evaluate the real-world implementation of the Friendship Bench (FB) - an evidence-based brief psychological intervention delivered by community health workers (CHWs) - three years after its implementation in three city health departments in Zimbabwe. Implementation sites were evaluated according to their current performance using the RE-AIM framework making this one of the first evaluations of a scaled-up evidence-based psychological intervention in sub-Saharan Africa (SSA). Methods: Using the RE-AIM guide ( www.re-aim.org ), the authors designed quantitative indicators based on existing FB implementation data. Thirty-six primary health care clinics (PHC) in Harare (n=28), Chitungwiza (n=4) and Gweru (n=4) were included. Among these clinics 20 were large comprehensive health care centers, 7 medium (mostly maternal and child healthcare) and 9 small clinics (basic medical care and acting as referral clinic). Existing data from these clinics, added to additionally collected data through interviews and field observations were used to investigate and compare the performance of the FB across clinics. The focus was on the RE-AIM domains of Reach, Adoption, and Implementation. Results: Small clinics achieved 34% reach, compared to large (15%) and medium clinics (9%). Adoption was high in all clinic types, ranging from 59% to 71%. Small clinics led the implementation domain with 53%, followed by medium sized clinics 43% and large clinics 40%. Small clinics performed better in all indicators and differences in performance between small and large clinics were significant. Program activity and data quality depends on ongoing support for delivering agents and buy-in from health authorities. Conclusion: The Friendship Bench program was implemented over three years transitioning from a research-based implementation program to one led locally. The Reach domain showed the largest gap across clinics where larger clinics performed poorly relative to smaller clinics and should be a target for future implementation improvements. Program data needs to be integrated into existing health information systems. Future studies should seek to optimize scale-up and sustainment strategies to maintain effective task-shared psychological interventions in SSA

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 feasibility hybrid II randomised controlled trial of volunteer ‘Health Champions’ supporting people with serious mental illness manage their physical health: study protocol

Background People with serious mental illnesses (SMI) such as schizophrenia often also have physical health illnesses and interventions are needed to address the resultant multimorbidity and reduced life expectancy. Research has shown that volunteers can support people with SMI. This protocol describes a feasibility randomised controlled trial (RCT) of a novel intervention involving volunteer ‘Health Champions’ supporting people with SMI to manage and improve their physical health. Methods This is a feasibility hybrid II randomised effectiveness-implementation controlled trial. The intervention involves training volunteers to be ‘Health Champions’ to support individual people with SMI using mental health services. This face-to-face or remote support will take place weekly and last for up to 9 months following initial introduction. This study will recruit 120 participants to compare Health Champions to treatment as usual for people with SMI using secondary community mental health services in South London, UK. We will measure the clinical and cost effectiveness including quality of life. We will measure the implementation outcomes of acceptability, feasibility, appropriateness, fidelity, barriers and enablers, unintended consequences, adoption and sustainability. Discussion There is a need for interventions to support people with SMI with their physical health. If this feasibility trial is successful, a definitive trial will follow to fully evaluate the clinical, cost and implementation effectiveness of Health Champions supporting people with SMI