Quality improvement interventions to increase the uptake of magnesium sulphate in preterm deliveries for the prevention of cerebral palsy (PReCePT study): a cluster randomised controlled trial.

OBJECTIVE: To compare two quality improvement (QI) interventions to improve antenatal magnesium sulphate (MgSO4 ) uptake in preterm births for the prevention of cerebral palsy. DESIGN: Unblinded cluster randomised controlled trial. SETTING: Academic Health Sciences Network, England, 2018. SAMPLE: Maternity units with ≥10 preterm deliveries annually and MgSO4 uptake of ≤70%; 40 (27 NPP, 13 enhanced support) were included (randomisation stratified by MgSO4 uptake). METHODS: The National PReCePT Programme (NPP) gave maternity units QI materials (clinical guidance, training), regional support, and midwife backfill funding. Enhanced support units received this plus extra backfill funding and unit-level QI coaching. MAIN OUTCOME MEASURES: MgSO4 uptake was compared using routine data and multivariable linear regression. Net monetary benefit was estimated, based on implementation costs, lifetime quality-adjusted life-years and societal costs. The implementation process was assessed through qualitative interviews. RESULTS: MgSO4 uptake increased in all units, with no evidence of any difference between groups (0.84 percentage points lower uptake in the enhanced group, 95% CI -5.03 to 3.35). The probability of enhanced support being cost-effective was <30%. NPP midwives gave more than their funded hours for implementation. Units varied in their support needs. Enhanced support units reported better understanding, engagement and perinatal teamwork. CONCLUSIONS: PReCePT improved MgSO4 uptake in all maternity units. Enhanced support did not further improve uptake but may improve teamwork, and more accurately represented the time needed for implementation. Targeted enhanced support, sustainability of improvements and the possible indirect benefits of stronger teamwork associated with enhanced support should be explored further.

The effectiveness of knowledge-sharing techniques and approaches in research funded by the National Institute for Health and Care Research (NIHR): a systematic review.

BACKGROUND: The National Institute of Health and Care Research (NIHR), funds, enables and delivers world-leading health and social care research to improve people's health and wellbeing. To achieve this aim, effective knowledge sharing (two-way knowledge sharing between researchers and stakeholders to create new knowledge and enable change in policy and practice) is needed. To date, it is not known which knowledge sharing techniques and approaches are used or how effective these are in creating new knowledge that can lead to changes in policy and practice in NIHR funded studies. METHODS: In this restricted systematic review, electronic databases [MEDLINE, The Health Management Information Consortium (including the Department of Health's Library and Information Services and King's Fund Information and Library Services)] were searched for published NIHR funded studies that described knowledge sharing between researchers and other stakeholders. One researcher performed title and abstract, full paper screening and quality assessment (Critical Appraisal Skills Programme qualitative checklist) with a 20% sample independently screened by a second reviewer. A narrative synthesis was adopted. RESULTS: In total 9897 records were identified. After screening, 17 studies were included. Five explicit forms of knowledge sharing studies were identified: embedded models, knowledge brokering, stakeholder engagement and involvement of non-researchers in the research or service design process and organisational collaborative partnerships between universities and healthcare organisations. Collectively, the techniques and approaches included five types of stakeholders and worked with them at all stages of the research cycle, except the stage of formation of the research design and preparation of funding application. Seven studies (using four of the approaches) gave examples of new knowledge creation, but only one study (using an embedded model approach) gave an example of a resulting change in practice. The use of a theory, model or framework to explain the knowledge sharing process was identified in six studies. CONCLUSIONS: Five knowledge sharing techniques and approaches were reported in the included NIHR funded studies, and seven studies identified the creation of new knowledge. However, there was little investigation of the effectiveness of these approaches in influencing change in practice or policy.

Developments in the design and delivery of self-management support for children and young people with diabetes: A narrative synthesis of systematic reviews.

AIMS: Facilitated self-management support programmes have become central to the treatment of chronic diseases including diabetes. For many children and young people with diabetes (CYPD), the impact on glycated haemoglobin (HbA1c ) and a range of self-management behaviours promised by these programmes remain unrealised. This warrants an appraisal of current thinking and the existing evidence to guide the development of programmes better targeted at this age group. METHODS: Create a narrative review of systematic reviews produced in the last 3 years that have explored the impact on CYPD of the four key elements of self-management support programmes: education, instruction and advice including peer support; psychological counselling via a range of therapies; self-monitoring, including diaries and telemetric devices; and telecare, the technology-enabled follow-up and support by healthcare providers. RESULTS: Games and gamification appear to offer a promising means of engaging and educating CYPD. Psychological interventions when delivered by trained practitioners, appear to improve HbA1c and quality of life although effect sizes were small. Technology-enabled interactive diaries can increase the frequency of self-monitoring and reduce levels of HbA1c . Telecare provided synchronously via telephone produced significant improvements in HbA1c . CONCLUSIONS: The cost-effective flexibility of increasing the reliance on technology is an attractive proposition; however, there are resource implications for digital connectivity in underserved populations. The need remains to improve the understanding of which elements of each component are most effective in a particular context, and how to optimise the influence and input of families, caregivers and peers.

Views of children with diabetes from underserved communities, and their families on diabetes, glycaemic control and healthcare provision: A qualitative evidence synthesis.

AIMS: Children and young people with diabetes (CYPD) from socio-economically deprived and/or ethnic minority groups tend to have poorer glucose control and greater risk of diabetes-related complications. In this systematic review of qualitative evidence (qualitative evidence synthesis, QES), we aimed to explore the experiences and views of clinical encounters in diabetes care from the perspectives of CYPD and their family/carers from underserved communities and healthcare professionals in diabetes care. METHODS: We searched 6 databases to March 2022 with extensive search terms, and used a thematic synthesis following methods of Thomas and Harden. RESULTS: We identified 7 studies and described 11 descriptive themes based on primary and secondary constructs. From these, three "analytical themes" were developed. (1) "Alienation of CYPD" relates to their social identity and interaction with peers, family and health service practitioners in the context of diabetes self- and family/carer management and is impacted by communication in the clinical encounter. (2) "Empowerment of CYPD and family/carers" explores families' understanding of risks and consequences of diabetes and taking responsibility for self- and family/carer management in the context of their socio-cultural background. (3) "Integration of diabetes (into self and family)" focuses on the ability to integrate diabetes self-management into the daily lives of CYPD and family/carers beyond the clinical consultation. CONCLUSIONS: The analytical themes are interdependent and provide a conceptual framework from which to explore and strengthen the therapeutic alliance in clinical encounters and to foster greater concordance with treatment plans. Communicating the biomedical aspects of managing diabetes in the clinical encounter is important, but should be balanced with addressing socio-emotional factors important to CYPD and family/carers.

Current evidence for designing self-management support for underserved populations: an integrative review using the example of diabetes.

AIMS: With numerous and continuing attempts at adapting diabetes self-management support programmes to better account for underserved populations, its important that the lessons being learned are understood and shared. The work we present here reviews the latest evidence and best practice in designing and embedding culturally and socially sensitive, self-management support programmes. METHODS: We explored the literature with regard to four key design considerations of diabetes self-management support programmes: Composition - the design and content of written materials and digital tools and interfaces; Structure - the combination of individual and group sessions, their frequency, and the overall duration of programmes; Facilitators - the combination of individuals used to deliver the programme; and Context - the influence and mitigation of a range of individual, socio-cultural, and environmental factors. RESULTS: We found useful and recent examples of design innovation within a variety of countries and models of health care delivery including Brazil, Mexico, Netherlands, Spain, United Kingdom, and United States of America. Within Composition we confirmed the importance of retaining best practice in creating readily understood written information and intuitive digital interfaces; Structure the need to offer group, individual, and remote learning options in programmes of flexible duration and frequency; Facilitators where the benefits of using culturally concordant peers and community-based providers were described; and finally in Context the need to integrate self-management support programmes within existing health systems, and tailor their various constituent elements according to the language, resources, and beliefs of individuals and their communities. CONCLUSIONS: A number of design principles across the four design considerations were identified that together offer a promising means of creating the next generation of self-management support programme more readily accessible for underserved communities. Ultimately, we recommend that the precise configuration should be co-produced by all relevant service and patient stakeholders and its delivery embedded in local health systems.

Ripple effects mapping: capturing the wider impacts of systems change efforts in public health.

BACKGROUND: Systems approaches are currently being advocated and implemented to address complex challenges in Public Health. These approaches work by bringing multi-sectoral stakeholders together to develop a collective understanding of the system, and then to identify places where they can leverage change across the system. Systems approaches are unpredictable, where cause-and-effect cannot always be disentangled, and unintended consequences - positive and negative - frequently arise. Evaluating such approaches is difficult and new methods are warranted. METHODS: Ripple Effects Mapping (REM) is a qualitative method which can capture the wider impacts, and adaptive nature, of a systems approach. Using a case study example from the evaluation of a physical activity-orientated systems approach in Gloucestershire, we: a) introduce the adapted REM method; b) describe how REM was applied in the example; c) explain how REM outputs were analysed; d) provide examples of how REM outputs were used; and e) describe the strengths, limitations, and future uses of REM based on our reflections. RESULTS: Ripple Effects Mapping is a participatory method that requires the active input of programme stakeholders in data gathering workshops. It produces visual outputs (i.e., maps) of the programme activities and impacts, which are mapped along a timeline to understand the temporal dimension of systems change efforts. The REM outputs from our example were created over several iterations, with data collected every 3-4 months, to build a picture of activities and impacts that have continued or ceased. Workshops took place both in person and online. An inductive content analysis was undertaken to describe and quantify the patterns within the REM outputs. Detailed guidance related to the preparation, delivery, and analysis of REM are included in this paper. CONCLUSION: REM may help to advance our understanding and evaluation of complex systems approaches, especially within the field of Public Health. We therefore invite other researchers, practitioners and policymakers to use REM and continuously evolve the method to enhance its application and practical utility.

Using the recommended summary plan for emergency care and treatment (ReSPECT) in care homes: a qualitative interview study.

BACKGROUND: The Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) is an advance care planning process designed to facilitate discussion and documentation of preferences for care in a medical emergency. Advance care planning is important in residential and nursing homes. AIM: To explore the views and experiences of GPs and care home staff of the role of ReSPECT in: (i) supporting, and documenting, conversations about care home residents' preferences for emergency care situations, and (ii) supporting decision-making in clinical emergencies. SETTING/PARTICIPANTS: Sixteen GPs providing clinical care for care home residents and 11 care home staff in the West of England. METHODS: A qualitative research design using semi-structured interviews. RESULTS: Participants' accounts described the ReSPECT process as facilitating person-centred conversations about residents' preferences for care in emergency situations. The creation of personalised scenarios supported residents to consider their preferences. However, using ReSPECT was complex, requiring interactional work to identify and incorporate resident or relative preferences. Subsequent translation of preferences into action during emergency situations also proved difficult in some cases. Care staff played an important role in facilitating and supporting ReSPECT conversations and in translating it into action. CONCLUSIONS: The ReSPECT process in care homes was positive for GPs and care home staff. We highlight challenges with the process, communication of preferences in emergency situations and the importance of balancing detail with clarity. This study highlights the potential for a multi-disciplinary approach engaging care staff more in the process.

Commissioner, clinician, and patient experiences of a pre-surgical health optimisation programme - a qualitative study.

BACKGROUND: Health optimisation programmes are an increasingly popular policy intervention that aim to support patients to lose weight or stop smoking ahead of surgery. There is little evidence about their impact and the experience of their use. The aim of this study was to investigate the experiences and perspectives of commissioners, clinicians and patients involved in a locality's health optimisation programme in the United Kingdom. The programme alters access to elective orthopaedic surgery for patients who smoke or are obese (body mass index ≥ 30 kg/m2), diverting them to a 12-week programme of behavioural change interventions prior to assessment for surgical referral. METHODS: A thematic analysis of semi-structured interviews (n = 20) with National Health Service and Local Authority commissioners and planners, healthcare professionals, and patients using the pathway. RESULTS: Health optimisation was broadly acceptable to professionals and patients in our sample and offered a chance to trigger both short term pre-surgical weight loss/smoking cessation and longer-term sustained changes to lifestyle intentions post-surgery. Communicating the nature and purpose of the programme to patients was challenging and consequently the quality of the explanation received and understanding gained by patients was generally low. Insight into the successful implementation of health optimisation for the hip and knee pathway, but failure in roll-out to other surgical specialities, suggests placement of health optimisation interventions into the 'usual waiting time' for surgical referral may be of greatest acceptability to professionals and patients. CONCLUSIONS: Patients and professionals supported the continuation of health optimisation in this context and recognised likely health and wellbeing benefits for a majority of patients. However, the clinicians' communication to patients about health optimisation needs to improve to prepare patients and optimise their engagement.

"Crazy person is crazy person. It doesn't differentiate": an exploration into Somali views of mental health and access to healthcare in an established UK Somali community.

BACKGROUND: Mental health conditions have been shown to disproportionately affect those from Black, Asian and Minority Ethnic (BAME) communities. Somali communities globally have relatively high levels of mental illness, but low levels of mental health service use, with numerous barriers to care identified. This study was conducted in an established UK Somali community in the South West of England and aimed to explore community beliefs and views about the causes of mental illness, treatment for mental illness, and access to medical services in general. Participants were asked about how mental health and illness are understood and conceptualised, along with the cultural meaning of mental illness and its manifestations in relation to men, women and young people. DESIGN: Using a community-based participatory research design, in partnership with local Somali community organisations, the research team conducted four focus groups with a total of 23 participants aged over 18. Open-ended questions were used to facilitate discussion. Transcripts were analysed thematically. RESULTS: The participants discussed the role of migration and associated stress from the civil war and how that could contribute to mental illness. Participants tended to view the symptoms of mental illness as physical manifestations such as headaches and to describe a strong community stigma where those with mental health conditions were viewed as "crazy" by others. Barriers to accessing healthcare included language barriers, waiting times and a mistrust of doctors. Various ideas for improvements were discussed, including ideas to reduce stigma and ideas for community initiatives. CONCLUSION: Cultural considerations and reducing stigma are vital in improving understanding of mental illness and improving access to mental health services, along with building relationships and trust between the Somali community and health care workers.

The introduction of a safety checklist in two UK hospital emergency departments: A qualitative study of implementation and staff use.

AIMS AND OBJECTIVES: To explore the extent to which a checklist designed to support patient safety in hospital Emergency Departments was recognised and used by staff. BACKGROUND: Patient crowding in UK Emergency Departments makes it difficult for staff to monitor all patients for signs of clinical deterioration. An Emergency Department Safety Checklist was developed at a UK hospital to ensure patients are regularly monitored. It was subsequently implemented in six hospitals and recommended for use across the National Health Service in England. METHODS: This was a qualitative study in two UK hospital Emergency Departments. Data collection consisted of sixty-six hours of nonparticipant observation and interviews with twenty-six staff. Observations were sampled across different days and times. Interviews sampled a range of staff. Data were analysed thematically. The study was undertaken in accordance with COREQ guidelines. RESULTS: Staff described the Emergency Department Safety Checklist as a useful prompt and reminder for monitoring patients' vital signs and other aspects of care. It was also reported as effective in communicating patient care status to other staff. However, completing the checklist was also described as a task which could be overlooked during busy periods. During implementation, the checklist was promoted to staff in ways that obscured its core function of maintaining patient safety. CONCLUSIONS: The Emergency Department Safety Checklist can support staff in maintaining patient safety. However, it was not fully recognised by staff as a core component of everyday clinical practice. RELEVANCE TO CLINICAL PRACTICE: The Emergency Department Safety Checklist is a response to an overcrowded environment. To realise the potential of the checklist, emergency departments should take the following steps during implementation: (a) focus on the core function of clinical safety, (b) fully integrate the checklist into the existing workflow and (c) employ a departmental team-based approach to implementation and training.

Inside, outside and in-between: The process and impact of co-producing knowledge about autism in a UK Somali community.

BACKGROUND: Co-production is predicated on equal power-sharing and responsibility in research partnerships. However, relatively few accounts exist that explore the subjective experience of how co-researchers achieve such equality, from the perspectives of public contributors and researchers. AIM: This paper aims to provide a unique insight into the process of co-production, by weaving personal reflections with principles to evaluate the impact arising from co-produced knowledge. It is based upon participatory research that was initiated by a 'lay' person, on behalf of a community organization, seeking support for Somali families who are affected by autism. The paper explores the evolving partnerships that began with community theatre and qualitative research and leading to extensive dissemination and impact, all of which has been jointly owned and negotiated by the co-researchers and community organizations. DISCUSSION: Initially, this paper reflects on the process, drawing on principles defined for co-production in health research and combining it with the co-researcher's personal reflections of their experiences as insiders and outsiders, stepping in and out of each other's worlds. The value of reciprocity, flexibility and continuous reflection is illustrated. The latter part of the paper explores the impact of this co-produced knowledge using a theoretical framework, to assess the specific impacts and its broader transformative potential. It demonstrates how (1) opportunities for all partners to be equitably involved to the maximum degree possible throughout the research process can affect social change and (2) co-produced research can become a catalyst that is dynamic and complex, achieving multi-layered impact.

'You are labelled by your children's disability' - A community-based, participatory study of stigma among Somali parents of children with autism living in the United Kingdom.

OBJECTIVES: Social stigma is commonly experienced by parents of children with autism. Our aim was to understand the nature of stigma experienced by Somali parents of children with autism in the United Kingdom (UK), and to consider how they coped with or resisted such stigma. DESIGN: We used a community-based participatory research approach, collaborating with a community organisation of Somali parents. In-depth interviews with simultaneous translation were conducted with 15 Somali parents of children with autism living in Bristol, UK, in 2015. Parents were sampled purposively to capture diversity in children's age, severity of autism and time since diagnosis. Directed thematic analysis used Link and Phelan's model of stigma. RESULTS: Of the 15 participants, 12 were mothers (mean age 36). The 17 children with autism they cared for were 4-13 years' old, and five were girls. Two main themes with sub-themes were identified: the nature of stigma (labelling and stereotyping; separation; emotional reactions, discrimination and power), and coping and resistance (the power of language; faith as a resource; learning, peer support and community relationships). Children with autism were labelled and stereotyped (e.g. as 'sick', 'naughty', 'different') and parents blamed for not controlling them, leading to social rejection and isolation. Stigma was associated with a poor understanding of autism, a lack of vocabulary related to autism in the Somali community, and prejudice against mental illness and disability. There was evidence of enacted and felt stigma and examples of discrimination. Finding their own language to describe their child's condition and drawing on faith, learning and peer support were important resources in resisting stigma. CONCLUSIONS: Findings inform support for this community, highlighting the need to raise awareness of autism, enable parents to speak openly, and ensure appropriate professional services and interventions are available.

Physical Activity, Sedentary Time, and Frailty in Older Migrant Women From Ethnically Diverse Backgrounds: A Mixed-Methods Study.

There is limited evidence examining the association between physical activity (PA), sedentary time (ST), frailty, and factors influencing PA behaviors in migrant older women from ethnically diverse backgrounds. The aims of this mixed-methods study were to: 1) examine PA levels and ST across frailty status; 2) identify any differences in PA/ST between ethnic and religious groups; and 3) qualitatively explore factors influencing PA among older (≥60 years) migrant women (n = 60). PA/ST were assessed using accelerometry and frailty status using the frailty phenotype. Key factors influencing PA were explored via semi-structured interviews (n = 36) and analyzed using thematic analysis. Participants were highly sedentary irrespective of frailty status. Moderate-to-vigorous-physical activity (MVPA) was independently associated with frailty. Participants spent 69% of waking time in ST, with only 15% meeting current weekly PA recommendations. Health-related and socio-cultural factors were reported as common barriers to achieving PA recommendations. Maintaining independence, preventing physical decline and depression were key factors promoting PA. Understanding the challenges and needs of this population can help to inform strategies to promote PA and thus optimize physical function.

Nutrient Intake and Factors Influencing Eating Behaviors in Older Migrant Women Living in the United Kingdom.

This study examines nutrient intake and factors influencing eating behaviors in a sample of 76 migrant older women (≥ 60 years) living in the UK. Nutrient intake was assessed using a 24-hr recall enhanced by an in-depth probing dietary interview. Median energy intake was significantly lower than the UK RNIs (5,125.4 v. 7,301.1 kJ/d, p < .001). Main nutrients of concern were retinol, vitamin D, magnesium, potassium, copper, selenium, and monounsaturated fatty acids. Semistructured interviews were conducted with a subsample (n = 46) and analyzed using thematic analysis. Although women were knowledgeable about what constitutes a healthy diet, factors such as the presence and awareness of obesity and noncommunicable diseases, changes to household roles, and dietary restrictions related to religious beliefs were identified key influences on participants' dietary intake. Strategies targeting this population need to promote not only a healthy energy balance, but also dietary adequacy to optimize nutrient intake.

Integration of research and practice to improve public health and healthcare delivery through a collaborative 'Health Integration Team' model - a qualitative investigation.

BACKGROUND: Economic considerations and the requirement to ensure the quality, safety and integration of research with health and social care provision have given rise to local developments of collaborative organisational forms and strategies to span the translational gaps. One such model - the Health Integration Team (HIT) model in Bristol in the United Kingdom (UK) - brings together National Health Service (NHS) organisations, universities, local authorities, patients and the public to facilitate the systematic application of evidence to promote integration across healthcare pathways. This study aimed to (1) provide empirical evidence documenting the evolution of the model; (2) to identify the social and organisational processes and theory of change underlying healthcare knowledge and practice; and (3) elucidate the key aspects of the HIT model for future development and translation to other localities. METHODS: Contemporaneous documents were analysed, using procedures associated with Framework Analysis to produce summarised data for descriptive accounts. In-depth interviews were undertaken with key informants and analysed thematically. Comparative methods were applied to further analyse the two data sets. RESULTS: One hundred forty documents were analysed and 10 interviews conducted with individuals in leadership positions in the universities, NHS commissioning and provider organisations involved in the design and implementation of the HIT model. Data coalesced around four overarching themes: 'Whole system' engagement, requiring the active recruitment of all those who have a stake in the area of practice being considered, and 'collaboration' to enable coproduction were identified as 'process' themes. System-level integration and innovation were identified as potential 'outcomes' with far-reaching impacts on population health and service delivery. CONCLUSION: The HIT model emerged as a particular response to the perceived need for integration of research and practice to improve public health and healthcare delivery at a time of considerable organisational turmoil and financial constraints. The concept gained momentum and will likely be of interest to those involved in setting up similar arrangements, and researchers in the social and implementation sciences with an interest in their evaluation.

Health care professionals' views of paediatric outpatient non-attendance: implications for general practice.

BACKGROUND: Non-attendance at paediatric hospital outpatient appointments poses potential risks to children's health and welfare. Prevention and management of missed appointments depends on the perceptions of clinicians and decision makers from both primary and secondary care, including general practitioners (GPs) who are integral to non-attendance follow-up. OBJECTIVES: To examine the views of clinical, managerial and executive health care staff regarding occurrence and management of non-attendance at general paediatric outpatient clinics. METHODS: A qualitative study using individual semi-structured interviews was carried out at three English Primary Care Trusts and a nearby children's hospital. Interviews were conducted with 37 staff, including GPs, hospital doctors, other health care professionals, managers, executives and commissioners. Participants were recruited through purposive and 'snowball' sampling methods. Data were analysed following a thematic framework approach. RESULTS: GPs focused on situational difficulties for families, while hospital-based staff emphasized the influence of parents' beliefs on attendance. Managers, executives and commissioners presented a broad overview of both factors, but with less detailed views. All groups discussed sociodemographic factors, with non-attendance thought to be more likely in 'chaotic families'. Hospital interviewees emphasized child protection issues and the need for thorough follow-up of missed appointments. However, GPs were reluctant to interfere with parental responsibilities. CONCLUSION: Parental motivation and practical and social barriers should be considered. Responsibilities regarding missed appointments are not clear across health care sectors, but GPs are uniquely placed to address non-attendance issues and are central to child safeguarding. Primary care policies and strategies could be introduced to reduce non-attendance and ensure children receive the care they require.

Improving quality and safety of care using "technovigilance": an ethnographic case study of secondary use of data from an electronic prescribing and decision support system.

CONTEXT: "Meaningful use" of electronic health records to improve quality of care has remained understudied. We evaluated an approach to improving patients' safety and quality of care involving the secondary use of data from a hospital electronic prescribing and decision support system (ePDSS). METHODS: We conducted a case study of a large English acute care hospital with a well-established ePDSS. Our study was based on ethnographic observations of clinical settings (162 hours) and meetings (28 hours), informal conversations with clinical staff, semistructured interviews with ten senior executives, and the collection of relevant documents. Our data analysis was based on the constant comparative method. FINDINGS: This hospital's approach to quality and safety could be characterized as "technovigilance." It involved treating the ePDSS as a warehouse of data on clinical activity and performance. The hospital converted the secondary data into intelligence about the performance of individuals, teams, and clinical services and used this as the basis of action for improvement. Through a combination of rapid audit, feedback to clinical teams, detailed and critical review of apparent omissions in executive-led meetings, a focus on personal professional responsibility for patients' safety and quality care, and the correction of organizational or systems defects, technovigilance was-based on the hospital's own evidence-highly effective in improving specific indicators. Measures such as the rate of omitted doses of medication showed marked improvement. As do most interventions, however, technovigilance also had unintended consequences. These included the risk of focusing attention on aspects of patient safety made visible by the system at the expense of other, less measurable but nonetheless important, concerns. CONCLUSIONS: The secondary use of electronic data can be effective for improving specific indicators of care if accompanied by a range of interventions to ensure proper interpretation and appropriate action. But care is needed to avoid unintended consequences.

Using the framework method for the analysis of qualitative data in multi-disciplinary health research.

BACKGROUND: The Framework Method is becoming an increasingly popular approach to the management and analysis of qualitative data in health research. However, there is confusion about its potential application and limitations. DISCUSSION: The article discusses when it is appropriate to adopt the Framework Method and explains the procedure for using it in multi-disciplinary health research teams, or those that involve clinicians, patients and lay people. The stages of the method are illustrated using examples from a published study. SUMMARY: Used effectively, with the leadership of an experienced qualitative researcher, the Framework Method is a systematic and flexible approach to analysing qualitative data and is appropriate for use in research teams even where not all members have previous experience of conducting qualitative research.

Effects of a computerized feedback intervention on safety performance by junior doctors: results from a randomized mixed method study.

BACKGROUND: The behaviour of doctors and their responses to warnings can inform the effective design of Clinical Decision Support Systems. We used data from a University hospital electronic prescribing and laboratory reporting system with hierarchical warnings and alerts to explore junior doctors' behaviour. The objective of this trial was to establish whether a Junior Doctor Dashboard providing feedback on prescription warning information and laboratory alerting acceptance rates was effective in changing junior doctors' behaviour. METHODS: A mixed methods approach was employed which included a parallel group randomised controlled trial, and individual and focus group interviews. Junior doctors below the specialty trainee level 3 grade were recruited and randomised to two groups. Every doctor (N = 42) in the intervention group was e-mailed a link to a personal dashboard every week for 4 months. Nineteen participated in interviews. The 44 control doctors did not receive any automated feedback. The outcome measures were the difference in responses to prescribing warnings (of two severities) and laboratory alerting (of two severities) between the months before and the months during the intervention, analysed as the difference in performance between the intervention and the control groups. RESULTS: No significant differences were observed in the rates of generating prescription warnings, or in the acceptance of laboratory alarms. However, responses to laboratory alerts differed between the pre-intervention and intervention periods. For the doctors of Foundation Year 1 grade, this improvement was significantly (p = 0.002) greater in the group with access to the dashboard (53.6% ignored pre-intervention compared to 29.2% post intervention) than in the control group (47.9% ignored pre-intervention compared to 47.0% post intervention). Qualitative interview data indicated that while junior doctors were positive about the electronic prescribing functions, they were discriminating in the way they responded to other alerts and warnings given that from their perspective these were not always immediately clinically relevant or within the scope of their responsibility. CONCLUSIONS: We have only been able to provide weak evidence that a clinical dashboard providing individualized feedback data has the potential to improve safety behaviour and only in one of several domains. The construction of metrics used in clinical dashboards must take account of actual work processes. TRIAL REGISTRATION ISRCTN: ISRCTN72253051.

Scaling up an intervention to protect preterm infants from neurodevelopmental disabilities - findings from a qualitative process evaluation comparing standard with enhanced quality improvement support packages for maternity units in England.

BACKGROUND: A quality improvement strategy (PReCePT) was used in a standard and enhanced format to scale up a clinical intervention (administering magnesium sulphate to women in preterm labour) across all maternity units in England to protect prematurely born infants from neurodevelopmental disabilities. Formal evaluations reported the effectiveness of the standard package alone in increasing the administration of magnesium sulphate. In this paper, we focus on the findings of the process evaluations, using normalisation process theory to explain how different implementation contexts generated the observed outcomes relating to normative and relational restructuring and sustainment. METHODS: Interviews were conducted with key individuals in implementation of leadership positions nationally and locally. Interviews were analysed initially using the framework method. We then engaged recursively with NPT constructs to generate generalisable insights with pragmatic applicability in other settings. RESULTS: In total, 72 interviews were conducted with good representation from units across England and staff from the National Academic Health Science Network. We found that all units irrespective of whether they received a standard or enhanced QI package were successful in the 'normative restructuring' of their setting to enable magnesium sulphate to be administered. This suggests that this implementation outcome is necessary to achieve improvements. However, it may not be sufficient to sustain the changes once additional resources have been withdrawn. Sustainment, our findings suggest, required 'relational restructuring' to accommodate altered workflows and facilitate the sharing of responsibilities and tasks in daily practice. Relational restructuring was more likely to have been achieved units receiving enhanced QI support but also happened in units with standard QI support, especially in those where perinatal team working was already well established. CONCLUSION: Unlike other large QI-focused spread-and-scale programmes which failed to show any impact on outcomes, the PReCePT programme in both the enhanced and standard support packages led to improvements in the uptake of magnesium sulphate. The findings suggest that QI programmes interact with the enabling factors, such as strong interprofessional team working, already present in the setting. A standard package with minimal support was therefore sufficient in settings with enabling factors, but enhanced support was required in units where these were absent.