Surgery (Austin & Northern Health) - Research Publications

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    An evaluation of the implementation of interventions to reduce postoperative infections and optimise antibiotic use across the surgical pathway in India: a mixed-methods exploratory study protocol.
    Ahuja, S ; Singh, S ; Charani, E ; Surendran, S ; Nampoothiri, V ; Edathadathil, F ; George, A ; Leather, A ; Tarrant, C ; Holmes, A ; Sevdalis, N ; Birgand, G (Springer Science and Business Media LLC, 2022-11-05)
    INTRODUCTION: Postoperative infections represent a significant burden of disease, demanding antibiotic prescriptions, and are contributing to antimicrobial resistance. The burden of infection as a surgical complication is greater in low- and middle-income countries (LMICs). We report the protocol of a pilot study for the co-design, implementation and evaluation of two infection prevention and control (IPC) and antimicrobial stewardship (AMS) interventions across the surgical pathway in a teaching hospital in India. METHODS AND ANALYSIS: The two interventions developed following in-depth qualitative enquiry are (i) surveillance and feedback of postoperative infections to optimise the use of antibiotics in two surgical departments (gastrointestinal and cardiovascular and thoracic surgery) and (ii) raising awareness amongst patients, carers and members of public about IPC and AMS. We will conduct a prospective study, formatively evaluating the implementation process of delivering the two co-designed interventions using implementation science frameworks. The study will systematically assess the context of intervention delivery, so that implementation support for the interventions may be adapted to the needs of stakeholders throughout the study. Analysis of implementation logs and interviews with stakeholders upon completion of the implementation period, will offer insights into the perceived acceptability, appropriateness, feasibility and sustainability of the interventions and their implementation support. Implementation costs will be captured descriptively. Feasibility of clinical data collection to investigate effectiveness of interventions will also be assessed for a future larger study. Thematic framework analysis and descriptive statistics will be used to report the qualitative and quantitative data, respectively. STRENGTHS AND LIMITATIONS OF THIS STUDY: • The paired interventions have been co-designed from their inception with involvement of stakeholders at different stages in the surgical pathway. • Simultaneous evaluation of implementation and clinical outcomes will inform the development of a future larger study to enable/assess the scalability of interventions • The study offers a novel combination of implementation theory-informed, stakeholder-driven and clinically relevant evaluation, carried out in the context of a middle-income country hospital. • The project may not be applicable to every low-resource setting and surgical context due to differences in healthcare systems and cultures. However, the application of implementation science concepts may facilitate transferability and adaptation to other settings.
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    Mixed-methods implementation study of a virtual culturally tailored diabetes self-management programme for African and Caribbean communities (HEAL-D) in south London and its scaling up across NHS regions in England: study protocol.
    Lowry, S ; Goff, L ; Irwin, S ; Brady, O ; Curran, N ; Lelliott, Z ; Sevdalis, N ; Walker, A (BMJ, 2022-11-08)
    INTRODUCTION: The National Health Service Insight Prioritisation Programme was established to accelerate the implementation and evaluation of innovation that supports post-pandemic working. Supporting this, the Academic Health Science Network and National Institute for Health and Care Research Applied Research Collaboration in South London are testing and evaluating the implementation and scale-up of a type 2 diabetes (T2D) intervention.T2D is estimated to be three times more prevalent in UK African and Caribbean communities than in white Europeans. To tackle ethnic inequities in T2D healthcare access, an evidence-based, culturally tailored self-management and education programme for African and Caribbean adults (Healthy Eating & Active Lifestyles for Diabetes, HEAL-D) has been codeveloped with people with lived experience. Initially a face-to-face programme, HEAL-D pivoted to virtual delivery in response to COVID-19.The purpose of this study is to explore the (1) feasibility and acceptability of a virtual delivery model for HEAL-D in south London and (2) factors affecting its scale-up across other areas in England. METHODS AND ANALYSIS: The study will have two strands: (1) mixed-methods prospective evaluation of HEAL-D virtual delivery in south London using routinely collected service-level data, service delivery staff and service user interviews and observations; and (2) prospective qualitative study of the scale-up of this virtual delivery comprising interviews and focus groups with members of the public, and diabetes services commissioners and providers across England. Qualitative data will be analysed using thematic analysis. Quantitative analysis will use descriptive statistics and reporting summary tables and figures. The study will be grounded in well-established implementation frameworks and service user involvement. ETHICS AND DISSEMINATION: 'Minimal Risk Registration' ethical clearance was granted by King's College London's Research Ethics Office (ref: MRA-21/22-28498). Results will be published in a peer-reviewed journal and summaries provided to the study funders and participants.
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    Scaling up of safety and quality improvement interventions in perioperative care: a systematic scoping review of implementation strategies and effectiveness.
    White, MC ; Ahuja, S ; Peven, K ; McLean, SR ; Hadi, D ; Okonkwo, I ; Clancy, O ; Turner, M ; Henry, JCA ; Sevdalis, N (BMJ, 2022-10)
    BACKGROUND: Globally, 5 billion people lack access to safe surgical care with more deaths due to lack of quality care rather than lack of access. While many proven quality improvement (QI) interventions exist in high-income countries, implementing them in low/middle-income countries (LMICs) faces further challenges. Currently, theory-driven, systematically articulated knowledge of the factors that support successful scale-up of QI in perioperative care in these settings is lacking. We aimed to identify all perioperative safety and QI interventions applied at scale in LMICs and evaluate their implementation mechanisms using implementation theory. METHODS: Systematic scoping review of perioperative QI interventions in LMICs from 1960 to 2020. Studies were identified through Medline, EMBASE and Google Scholar. Data were extracted in two phases: (1) abstract review to identify the range of QI interventions; (2) studies describing scale-up (three or more sites), had full texts retrieved and analysed for; implementation strategies and scale-up frameworks used; and implementation outcomes reported. RESULTS: We screened 45 128 articles, identifying 137 studies describing perioperative QI interventions across 47 countries. Only 31 of 137 (23%) articles reported scale-up with the most common intervention being the WHO Surgical Safety Checklist. The most common implementation strategies were training and educating stakeholders, developing stakeholder relationships, and using evaluative and iterative strategies. Reporting of implementation mechanisms was generally poor; and although the components of scale-up frameworks were reported, relevant frameworks were rarely referenced. CONCLUSION: Many studies report implementation of QI interventions, but few report successful scale-up from single to multiple-site implementation. Greater use of implementation science methodology may help determine what works, where and why, thereby aiding more widespread scale-up and dissemination of perioperative QI interventions.
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    Defining, conceptualizing and evaluating pragmatic qualities of quantitative instruments measuring implementation determinants and outcomes: a scoping and critical review of the literature and recommendations for future research.
    Hull, L ; Boulton, R ; Jones, F ; Boaz, A ; Sevdalis, N (Oxford University Press (OUP), 2022-11-21)
    The pragmatic (i.e., practical) quality of quantitative implementation measures has received increased attention in the implementation science literature in recent years. Implementation measures that are judged to be pragmatic by implementation stakeholders are thought to be more likely to be applied in research and practice. Despite the need for pragmatic implementation measures, ambiguity and uncertainty regarding what constitutes a pragmatic measure remains. This study sought to identify and critically appraise the published literature to understand (i) how pragmatism is defined as a measurement construct/quality of implementation determinants and outcome instruments; (ii) how pragmatic qualities of instruments are evaluated; (iii) identify key gaps and limitations of the current evidence-base and (iv) identify recommendations for future research. We conducted a scoping review of the literature also employing methods of critical review. PubMed and PsycINFO databases, using the OVID interface, were searched for relevant articles published between January 2010 and September 2020. Articles that contained a definition and/or described characteristics of "pragmatism" as a measurement construct of quantitative implementation outcomes (as defined by Proctor's Implementation Outcomes taxonomy) and/or implementation determinants were eligible for inclusion. Nine articles met inclusion criteria. A degree of overlap in definitions and terms used to describe the pragmatic qualities of quantitative implementation determinant and outcome instruments were found. The most frequently cited descriptors of pragmatism were "not burdensome", "brief", "reliable", "valid" and "sensitive to change". 3 of the 9 included articles involved international implementation stakeholders in defining and conceptualizing pragmatism and employed specific methods to do so, including a systematic literature review, stakeholder interviews, concept mapping, and a Delphi process. All other articles defined pragmatism, with or without citing relevant literature. One article objectively assessed the pragmatic qualities, above and beyond the psychometric qualities, of implementation measures, using the Psychometric and Pragmatic Evidence Rating Scale (PAPERS). The evidence base within the implementation instrumentation literature on what pragmatism is and how it might be assessed is limited. Some of the research identified in the review provides a strong foundation to build upon, by testing its applicability in other settings (including healthcare areas and countries) and among a more diverse group of stakeholders. We discuss directions for further development of the concept of pragmatism relating to the measurement of implementation determinants and outcomes.
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    Parents' intention to vaccinate their child for COVID-19: A mixed-methods study (CoVAccS-wave 3).
    Smith, LE ; Sherman, SM ; Sim, J ; Amlôt, R ; Cutts, M ; Dasch, H ; Sevdalis, N ; Rubin, GJ ; Pinto da Costa, M (Public Library of Science (PLoS), 2022)
    AIM: To investigate UK parents' vaccination intention at a time when COVID-19 vaccination was available to some children. METHODS: Data reported are from the second wave of a prospective cohort study. We conducted a mixed-methods study using an online survey of 270 UK parents (conducted 4-15 October 2021). At this time, vaccination was available to 16- and 17-year-olds and had become available to 12- to 15-year-olds two weeks prior. We asked participants whose child had not yet been vaccinated how likely they were to vaccinate their child for COVID-19. Linear regression analyses were used to investigate factors associated with intention (quantitative component). Parents were also asked for their main reasons behind vaccination intention. Open-ended responses were analysed using content analysis (qualitative component). RESULTS: Parental vaccination intention was mixed (likely: 39.3%, 95% CI 32.8%, 45.7%; uncertain: 33.9%, 95% CI 27.7%, 40.2%; unlikely: 26.8%, 95% CI 20.9%, 32.6%). Intention was associated with: parental COVID-19 vaccination status; greater perceived necessity and social norms regarding COVID-19 vaccination; greater COVID-19 threat appraisal; and lower vaccine safety and novelty concerns. In those who intended to vaccinate their child, the main reasons for doing so were to protect the child and others. In those who did not intend to vaccinate their child, the main reason was safety concerns. CONCLUSIONS: Parent COVID-19 vaccination status and psychological factors explained a large percentage of the variance in vaccination intention for one's child. Further study is needed to see whether parents' intention to vaccinate their child is affected by fluctuating infection rates, more children being vaccinated, and the UK's reliance on vaccination as a strategy to live with COVID-19.
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    Development and psychometric evaluation of the Implementation Science Research Project Appraisal Criteria (ImpResPAC) tool: a study protocol.
    Sweetnam, C ; Goulding, L ; Davis, RE ; Khadjesari, Z ; Boaz, A ; Healey, A ; Sevdalis, N ; Bakolis, I ; Hull, L (BMJ, 2022-12-16)
    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).
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    Patient safety in community-based mental healthcare: A systematic scoping review
    Averill, P ; Vincent, C ; Reen, G ; Sevdalis, N ; Henderson, C (Royal College of Psychiatrists, 2022-06)
    Introduction There is limited existing research about patient safety issues in mental healthcare. A lack of evidence is particularly pronounced in relation to safety in community-based mental health services, where the majority of care is provided. To date, reviews of mental health patient safety literature have focused primarily on inpatient care settings. Objectives This systematic scoping review will aim to identify and synthesise literature about the types of patient safety problems in adult community-based mental health settings, the causes of these problems, and evaluated safety interventions in this care context. Methods A systematic search was conducted on 19th June 2020 and refreshed on 23rd October 2021, across five databases: Medline, Embase, PsycINFO, Health Management Information Consortium, and Cumulative Index to Nursing and Allied Health Literature. The search strategy focused on three key elements: ‘mental health’, ‘patient safety’ and ‘community-based mental health services’. Retrieved articles were screened at title, abstract and subject heading level, followed by full-text screen of longlisted articles. Results In this presentation, the findings of this systematic scoping review will be described, based on synthesised literature about safety incidents, broader care delivery problems, their causes, and evaluated patient safety interventions to address these issues. Conclusions This study will offer learning opportunities about the safety problems, contributory factors, and safety interventions in adult community-based mental health services, as described in the evidence base. Review findings will also help to ascertain gaps in existing research, which should be addressed in future studies. Disclosure NS is the director of London Safety and Training Solutions Ltd, which offers training in patient safety, implementation solutions and human factors to healthcare organisations and the pharmaceutical industry. The other authors have no competing interests.
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    Cancer multidisciplinary team meetings: impact of logistical challenges on communication and decision-making.
    Soukup, T ; Lamb, BW ; Morbi, A ; Shah, NJ ; Bali, A ; Asher, V ; Gandamihardja, T ; Giordano, P ; Darzi, A ; Sevdalis, N ; Green, JSA (Oxford University Press (OUP), 2022-07-07)
    BACKGROUND: Multidisciplinary teams (MDTs) are widely used in cancer care. Recent research points to logistical challenges impeding MDT decision-making and dissatisfaction among members. This study sought to identify different types of logistical issues and how they impacted team processes. METHODS: This was a secondary analysis of a cross-sectional observational study. Three cancer MDTs (breast, colorectal, and gynaecological) were recruited from UK hospitals. Validated observational instruments were used to measure decision-making (Metrics of Observational Decision-making, MDT-MODe), communication (Bales' Interaction Process Analysis, Bales' IPA), and case complexity (Measure of Case Discussion Complexity, MeDiC), including logistical challenges (Measure of Case Discussion Complexity, MeDiC), across 822 case discussions from 30 videoed meetings. Descriptive analysis and paired samples t tests were used to identify and compare frequency of different types of logistical challenges, along with partial correlations, controlling for clinical complexity of cases, to understand how such issues related to the MDT decision-making and communication. RESULTS: A significantly higher frequency of administrative and process issues (affecting 30 per cent of cases) was seen compared with the frequency of equipment issues (affecting 5 per cent of cases; P < 0.001) and the frequency of the attendance issues (affecting 16 per cent of cases; P < 0.001). The frequency of the attendance issues was significantly higher than the frequency of equipment issues (P < 0.001). Partial correlation analysis revealed that administrative and process issues, including attendance, were negatively correlated with quality of information (r = -0.15, P < 0.001; r = -0.11, P < 0.001), and equipment issues with the quality of contribution to meeting discussion (r = -0.14, P < 0.001). More questioning and answering by MDT members was evident with the administrative and process issues (r = 0.21, P < 0.001; r = 0.19, P < 0.001). Some differences were observed in teams' socioemotional reactions to the administrative and process issues with the gynaecological MDT showing positive correlation with positive socioemotional reactions (r = 0.20, P < 0.001), and the breast cancer MDT with negative socioemotional reactions (r = 0.17, P < 0.001). CONCLUSION: Administrative and process issues were the most frequent logistical challenges for the studied teams. Where diagnostic results were unavailable, and inadequate patient details provided, the quality of decision-making was reduced.
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    Online singing interventions for postnatal depression in times of social isolation: a feasibility study protocol for the SHAPER-PNDO single-arm trial.
    Bind, RH ; Estevao, C ; Fancourt, D ; Hazelgrove, K ; Sawyer, K ; Rebecchini, L ; Miller, C ; Dazzan, P ; Sevdalis, N ; Woods, A ; Crane, N ; Manoharan, M ; Burton, A ; Dye, H ; Osborn, T ; Greenwood, L ; Bakolis, I ; Lopez, MB ; Davis, R ; Perkins, R ; Pariante, CM (Springer Science and Business Media LLC, 2022-07-18)
    BACKGROUND: Postnatal depression (PND) affects 13% of new mothers, with numbers rising during the COVID-19 pandemic. Despite this prevalence, many women have difficulty with or hesitancy towards accessing pharmacological and/or psychological interventions. Group-based mother-baby activities, however, have a good uptake, with singing improving maternal mental health and the mother-infant relationship. The recent lockdowns highlight the importance of adapting activities to an online platform that is wide-reaching and accessible. AIMS: The SHAPER-PNDO study will primarily analyse the feasibility of a 6-week online singing intervention, Melodies for Mums (M4M), for mothers with PND who are experiencing barriers to treatment. The secondary aim of the SHAPER-PNDO study will be to analyse the clinical efficacy of the 6-week M4M intervention for symptoms of postnatal depression. METHODS: A total of 120 mothers and their babies will be recruited for this single-arm study. All dyads will attend 6 weekly online singing sessions, facilitated by Breathe Arts Health Research. Assessments will be conducted on Zoom at baseline and week 6, with follow-ups at weeks 16 and 32, and will contain interviews for demographics, mental health, and social circumstances, and biological samples will be taken for stress markers. Qualitative interviews will be undertaken to understand the experiences of women attending the sessions and the facilitators delivering them. Finally, data will be collected on recruitment, study uptake and attendance of the programme, participant retention, and acceptability of the intervention. DISCUSSION: The SHAPER-PNDO study will focus on the feasibility, alongside the clinical efficacy, of an online delivery of M4M, available to all mothers with PND. We hope to provide a more accessible, effective treatment option for mothers with PND that can be available both during and outside of the pandemic for mothers who would otherwise struggle to attend in-person sessions, as well as to prepare for a subsequent hybrid RCT. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04857593 . Registered retrospectively on 22 April 2021. The first participants were recruited on 27 January 2021, and the trial is ongoing.
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    Protocol for a feasibility study and process evaluation of a psychosocially modelled diabetes education programme for young people with type 1 diabetes: the Youth Empowerment Skills (YES) programme.
    Kariyawasam, D ; Soukup, T ; Parsons, J ; Sevdalis, N ; Baldellou Lopez, M ; Forde, R ; Ismail, K ; Jones, M ; Ford-Adams, M ; Yemane, N ; Pender, S ; Thomas, S ; Murrells, T ; Silverstien, A ; Forbes, A (BMJ, 2022-06-09)
    INTRODUCTION: Adolescence is a challenging period for young people with type 1 diabetes, associated with worsening glycaemia and care disengagement. Educational interventions in this period tend to focus on diabetes-specific skills, with less emphasis on the psychosocial challenges associated with diabetes experienced by young people. To address this limitation, we codesigned with young people a psychosocially modelled programme of diabetes education, named 'Youth Empowerment Skills' (YES). The programme aims to facilitate a positive adaptation to life with diabetes and engagement with diabetes care through peer-based learning, immersive simulations and support from an outreach youth worker. Here, we present a protocol for a feasibility study of the YES programme. METHODS AND ANALYSIS: The study was designed following the Medical Research Council Complex Intervention Evaluation Framework to: test the feasibility (acceptance, implementability, recruitment and completion) of the YES programme; and estimate its efficacy in relation to metabolic and psychosocial outcomes. The study will take place in diabetes centres serving socioculturally diverse populations. We will conduct a feasibility randomised controlled trial (waiting-list design) with integrated process evaluation. Fifty young people with type 1 diabetes (aged 14-19 years) will be randomly allocated to either the YES intervention or a waiting-list control. Randomisation acceptability will be assessed with provision for a preference allocation. Outcomes will be evaluated at 6 months, at which point the waiting list participants will be exposed to the YES programme with further follow-up to 12 months. A simultaneous process evaluation will use a mixed-methods approach collecting qualitative and quantitative data. Study findings will be used to optimise the intervention components, outcome measures and recruitment methods to inform a subsequent definitive trial. ETHICS AND DISSEMINATION: The protocol has ethical approval from the UK Health Research Authority (approval IRAS project ID: 279877). Findings will be disseminated in multiple formats for lay and professional audiences. PROTOCOL DATE AND VERSION: 7 April 2021, V.1.1. TRIAL REGISTRATION NUMBER: NCT04670198.