Being pregnant and becoming a parent during the COVID-19 pandemic: a longitudinal qualitative study with women in the Born in Bradford COVID-19 research study.

BACKGROUND: Uncertainty around the risk of COVID-19 to pregnant women and their babies prompted precautionary restrictions on their health and care during the pandemic. Maternity services had to adapt to changing Government guidance. Coupled with the imposition of national lockdowns in England and restrictions on daily activities, women's experiences of pregnancy, childbirth and the postpartum period, and their access to services, changed rapidly. This study was designed to understand women's experiences of pregnancy, labour and childbirth and caring for a baby during this time. METHODS: This was an inductive longitudinal qualitative study, using in-depth interviews by telephone with women in Bradford, UK, at three timepoints during their maternity journey (18 women at timepoint one, 13 at timepoint two and 14 at timepoint three). Key topics explored were physical and mental wellbeing, experience of healthcare services, relationships with partners and general impact of the pandemic. Data were analysed using the Framework approach. A longitudinal synthesis identified over-arching themes. RESULTS: Three longitudinal themes captured what was important to women: (1) women feared being alone at critical points in their maternity journey, (2) the pandemic created new norms for maternity services and women's care, and (3) finding ways to navigate the COVID-19 pandemic in pregnancy and with a baby. CONCLUSIONS: Modifications to maternity services impacted significantly on women's experiences. The findings have informed national and local decisions about how best to direct resources to reduce the impact of COVID-19 restrictions and the longer-term psychological impact on women during pregnancy and postnatally.

"Everything the hujur tells is very educative but if I cannot apply those in my own life then there is no meaning": a mixed-methods process evaluation of a smoke-free homes intervention in Bangladesh.

BACKGROUND: Second-hand smoke exposure from tobacco significantly contributes to morbidity and mortality worldwide. A cluster RCT in Bangladesh compared a community-based smoke-free home (SFH) intervention delivered in mosques, with or without indoor air quality (IAQ) feedback to households to no intervention. Neither was effective nor cost-effective compared to no intervention using an objective measure of second-hand smoke. This paper presents the process evaluation embedded within the trial and seeks to understand this. METHODS: A mixed method process evaluation comprising interviews with 30 household leads and six imams (prayer leader in mosque), brief questionnaire completed by 900 household leads (75% response), fidelity assessment of intervention delivery in six (20%) mosques and research team records. Data were triangulated using meta-themes informed by three process evaluation functions: implementation, mechanisms of impact and context. RESULTS: IMPLEMENTATION: Frequency of SFH intervention delivery was judged moderate to good. However there were mixed levels of intervention fidelity and poor reach. Linked Ayahs (verses of the Qur'an) with health messages targeting SHS attitudes were most often fully implemented and had greatest reach (along with those targeting social norms). Frequency and reach of the IAQ feedback were good. MECHANISMS OF IMPACT: Both interventions had good acceptability. However, views on usefulness of the interventions in creating a SFH were mixed. Individual drivers to behaviour change were new SFH knowledge with corresponding positive attitudes, social norms and intentions. Individual barriers were a lack of self-efficacy and plans. CONTEXT: Social context drivers to SFH intervention implementation in mosques were in place and important. No context barriers to implementation were reported. Social context drivers to SHS behaviour change were children's requests. Barriers were women's reluctance to ask men to smoke outside alongside general reluctance to request this of visitors. (Not) having somewhere to smoke outside was a physical context (barrier) and driver. CONCLUSIONS: Despite detailed development and adaption work with relevant stakeholders, the SFH intervention and IAQ feedback became educational interventions that were motivational but insufficient to overcome significant context barriers to reduce objectively measured SHS exposure in the home. Future interventions could usefully incorporate practical support for SFH behaviour change. Moreover, embedding these into community wide strategies that include practical cessation support and enforcement of SFH legislation is needed. TRIAL REGISTRATION: Current Controlled Trials ISRCTN49975452.

Medical specialists' attitudes and practices towards childhood vaccination: a qualitative study in Armenia.

BACKGROUND: Childhood vaccination rates in Armenia are high. However, anecdotal evidence suggests that some health workers may advise against vaccination. The extent and reasons behind this are unknown. This study used the World Health Organization Tailoring Immunization Programmes approach to investigate medical specialists' vaccination practices. METHODS: Face-to-face interviews were conducted with 30 medical specialists (paediatricians, immunologists, neonatologists, neurologists, gynaecologists). Interviews explored their vaccination practices (recommending/administering), knowledge, attitudes and confidence. Data were analysed using the Framework approach and COM (Capability, Opportunity, Motivation) factors. FINDINGS: Medical specialists were routinely consulted by parents about vaccination. They engaged in conversations, even if they did not administer vaccinations and lacked expertise. Vaccination recommendation was "selective", influenced by their own vaccine hesitancy. Doctors administering vaccination used false contraindications to postpone vaccination. Multiple barriers and drivers to positive vaccination practices were evident, with differences between specialists administering/not administering vaccinations. Capability Drivers were knowledge of vaccination, vaccines, and vaccine-preventable diseases; with awareness and use of protocols for adverse events and contraindications (those with a vaccination role). Barriers were a lack of a detailed understanding of vaccination, vaccines, and vaccine-preventable diseases, especially amongst neonatologists and gynaecologists, and for HPV. Poor knowledge of adverse events and mixed knowledge of contraindications was evident, as was low confidence about conversations with parents declining vaccination. Opportunity Drivers were using "official" guidance and professional information and feeling protected by the Government of Armenia should an adverse event occur. Conversely, barriers were a reliance on media/social media without considering credibility, peers not recommending vaccination, increasing parent demands and not feeling protected by the Government. Motivation Drivers were seeing vaccination as their responsibility (those who administer vaccinations); and generally supporting vaccination. Barriers were vaccine hesitancy, some anti-vaccination sentiments amongst neonatologists and gynaecologists and not seeing vaccination as their role (those who do not administer vaccinations). CONCLUSIONS: Applying a theory-informed approach allowed us to identify critical issues and possible solutions. High vaccination coverage may disguise underlying issues, e.g. false contraindications. We addressed gaps in the literature, with our geographical focus and study of medical specialists advising parents on vaccination, a widely used practice in this sub-region.

Smokeless Tobacco Initiation, Use, and Cessation in South Asia: A Qualitative Assessment.

INTRODUCTION: Smokeless tobacco (ST) is a significant South Asian public health problem. This paper reports a qualitative study of a sample of South Asian ST users. METHODS: Interviews, using a piloted topic guide, with 33 consenting, urban dwelling adult ST users explored their ST initiation, continued use, and cessation attempts. Framework data analysis was used to analyze country specific data before a thematic cross-country synthesis was completed. RESULTS: Participants reported long-term ST use and high dependency. All reported strong cessation motivation and multiple failed attempts because of ease of purchasing ST, tobacco dependency, and lack of institutional support. CONCLUSIONS: Interventions to support cessation attempts among consumers of South Asian ST products should address the multiple challenges of developing an integrated ST policy, including cessation services. IMPLICATIONS: This study provides detailed understanding of the barriers and drivers to ST initiation, use, and cessation for users in Bangladesh, India, and Pakistan. It is the first study to directly compare these three countries. The insight was then used to adapt an existing behavioral support intervention for ST cessation for testing in these countries.

Smokeless tobacco products, supply chain and retailers' practices in England: a multimethods study to inform policy.

BACKGROUND: In England, many people of South Asian origin consume smokeless tobacco (ST). ST use can lead to oral cancer, which is disproportionately high in South Asians. Our aims were to assess the compliance of ST product retailers with statutory regulations and to explore the supply chain of ST. METHODS: We undertook a multimethods study between August 2017 and July 2019 in five English boroughs with a high proportion of ethnic South Asians. We purchased ST products and conducted field surveys with ST retailers at point of sale. Qualitative interviews were conducted with ST retailers and suppliers. ST packs were assessed for regulatory compliance, while quantitative and qualitative data triangulated information on retailers' practices and the ST supply chain. RESULTS: We collected 41 unique ST products, which included dry snuff, naswar, gutka, chewing tobacco and zarda. ST products were not registered, and demonstrated low compliance with health warning (14.6%) and packaging (56.1%) requirements. ST availability in surveyed boroughs was high (38.2%-69.7%); dry snuff, naswar and zarda were most commonly available. ST retailers demonstrated limited knowledge of regulations, and one-third were found to advertise ST at point of sale. Qualitative insights revealed illicit supply and distribution networks, as well as ST production in discreet locations. CONCLUSION: ST products are widely available in England, yet non-compliant with statutory regulations. In order to safeguard consumers, in particular ethnic South Asians, stronger efforts are needed to regulate the supply chain of ST at both national and international levels.

Improving immunization uptake rates among Gypsies, Roma and Travellers: a qualitative study of the views of service providers.

BACKGROUND: Gypsies, Roma and Travellers are at risk of low uptake of routine immunizations. Interventions to improve uptake in these communities are seldom evaluated. As part of a qualitative study exploring barriers and facilitators to immunization uptake in Travellers, we report service provider (SP) perspectives. METHODS: We interviewed immunization SPs working with six Traveller communities across four UK cities. Participants included frontline staff and those with strategic or commissioning roles. Semi-structured interviews explored perceived attitudes of Travellers to vaccinations, local service delivery, and opportunities and challenges to improving uptake. Audio-recordings were transcribed, analyzed thematically and mapped to a socio-ecological model of health. RESULTS: 39 SPs participated. Four overarching themes were identified: building trusting relationships between SPs and Travellers; facilitating attendance at appointments; improving record keeping and monitoring and responding to local and national policy change. Travellers were perceived as largely supportive of immunizations, though system and organizational processes were recognized barriers to accessing services. CONCLUSIONS: Findings were broadly consistent across Traveller groups and settings. The barriers identified could often be addressed within existing infrastructure, though require system or policy change. Development of a culturally competent system appears important to enable equity in access to immunizations for Travellers.

Preferences for interventions designed to increase cervical screening uptake in non-attending young women: How findings from a discrete choice experiment compare with observed behaviours in a trial.

BACKGROUND: Young women's attendance at cervical screening in the UK is continuing to fall, and the incidence of invasive cervical cancer is rising. OBJECTIVES: We assessed the preferences of non-attending young women for alternative ways of delivering cervical screening. DESIGN: Postal discrete choice experiment (DCE) conducted during the STRATEGIC study of interventions for increasing cervical screening uptake. Attributes included action required to arrange a test, location of the test, availability of a nurse navigator and cost to the National Health Service. SETTING AND PARTICIPANTS: Non-attending young women in two UK regions. MAIN OUTCOME MEASURES: Responses were analysed using a mixed multinomial logit model. A predictive analysis identified the most preferable strategy compared to current screening. Preferences from the DCE were compared with observed behaviours during the STRATEGIC trial. RESULTS: The DCE response rate was 5.5% (222/4000), and 94% of respondents agreed screening is important. Preference heterogeneity existed around attributes with strong evidence for test location. Relative to current screening, unsolicited self-sampling kits for home use appeared most preferable. The STRATEGIC trial showed this same intervention to be most effective although many women who received it and were screened, attended for conventional cytology instead. CONCLUSIONS: The DCE and trial identified the unsolicited self-sampling kit as the most preferred/effective intervention. The DCE suggested that the decision of some women receiving the kit in the trial to attend for conventional cytology may be due to anxieties around home testing coupled with a knowledge that ignoring the kit could potentially have life-changing consequences.

Identifying interventions with Gypsies, Roma and Travellers to promote immunisation uptake: methodological approach and findings.

BACKGROUND: In the UK, Gypsy, Roma and Traveller (GRT) communities are generally considered to be at risk of low or variable immunisation uptake. Many strategies to increase uptake for the general population are relevant for GRT communities, however additional approaches may also be required, and importantly one cannot assume that "one size fits all". Robust methods are needed to identify content and methods of delivery that are likely to be acceptable, feasible, effective and cost effective. In this paper, we describe the approach taken to identify potential interventions to increase uptake of immunisations in six GRT communities in four UK cities; and present the list of prioritised interventions that emerged. METHODS: This work was conducted in three stages: (1) a modified intervention mapping process to identify ideas for potential interventions; (2) a two-step prioritisation activity at workshops with 51 GRTs and 25 Service Providers to agree a prioritised list of potentially feasible and acceptable interventions for each community; (3) cross-community synthesis to produce a final list of interventions. The theoretical framework underpinning the study was the Social Ecological Model. RESULTS: Five priority interventions were agreed across communities and Service Providers to improve the uptake of immunisation amongst GRTs who are housed or settled on an authorised site. These interventions are all at the Institutional (e.g. cultural competence training) and Policy (e.g. protected funding) levels of the Social Ecological Model. CONCLUSIONS: The "upstream" nature of the five interventions reinforces the key role of GP practices, frontline workers and wider NHS systems on improving immunisation uptake. All five interventions have potentially broader applicability than GRTs. We believe that their impact would be enhanced if delivered as a combined package. The robust intervention development and co-production methods described could usefully be applied to other communities where poor uptake of immunisation is a concern. STUDY REGISTRATION: Current Controlled Trials ISRCTN20019630, Date of registration 01-08-2013, Prospectively registered.

Measles outbreak in Romania: understanding factors related to suboptimal vaccination uptake.

BACKGROUND: A large measles outbreak started in Romania in 2016. Current study aimed to (i) clarify who was affected by the outbreak, (ii) identify their barriers and drivers to vaccination and (iii) explore variation by population group. METHODS: This was a two-component study. Outbreak surveillance data for 6743 measles cases were reviewed to identify key characteristics. A survey was administered via telephone to 704 caregivers of measles cases (520 respondents) to explore capability, opportunity and motivation barriers to vaccination. Data were summarized descriptively for respondent characteristics and statements. Differences by population group (education, household income, ethnicity, setting and mobility) were explored using χ2 tests, Fisher's exact tests or regression models. RESULTS: Most cases were unvaccinated and lived in low coverage areas. Ethnic minorities were disproportionally affected. Most caregivers felt welcome at health facilities. Some were less satisfied with the waiting time and had found the vaccine out of stock. Not everybody knew that vaccines were free of charge. Less than half knew the child's next vaccination date, some had not been informed and did not know where to seek this information. Some said their peers did not vaccinate. Beliefs were generally supportive of vaccination; but many were concerned about vaccine safety and found they had not received good information about this. Conclusions varied greatly between minorities and less educated groups, compared with people with higher education levels. CONCLUSIONS: Identifying characteristics of the population affected and underlying factors can inform a strategy to avoid future outbreaks and further research to obtain deeper insights.

Understanding vaccine acceptance and demand-and ways to increase them.

Vaccination saves millions of lives, and the World Health Organization (WHO) European Region celebrated record high coverage in 2018. Still, national or sub-national coverage is insufficient to stop the spread of vaccine-preventable diseases. Health authorities are increasingly aware of the need to prioritize the "demand" side of vaccination. Achieving high and equitable vaccination uptake in all population groups is not a quick-fix; it requires long-term investment in multifaceted interventions, informed by research with the target groups. The WHO focuses on both individual and context determinants of vaccination behaviours. Individual determinants include risk perceptions, (dis)trust and perceived constraints; insights from psychology help us understand these. Context determinants include social norms, socioeconomic status and education level, and the way health systems are designed, operate and are financed. The WHO recommends using a proven theoretical model to understand vaccination behaviours and has adapted the "COM­B model" for their Tailoring Immunization Programmes (TIP) approach. This adapted model is described in the article. Informed by insights into the factors affecting vaccination behaviours, interventions and policies can be planned to increase vaccination uptake. Some evidence exists on proven methods to do this. At the individual level, some interventions have been seen to increase vaccination uptake, and experimental studies have assessed how certain messages or actions affect vaccination perceptions. At the context level, there is more documentation for effective strategies, including those that focus on making vaccination the easy, convenient and default behaviour and that focus on the interaction between caregivers and health workers.

Children Learning About Secondhand Smoke (CLASS II): A Pilot Cluster Randomized Controlled Trial.

INTRODUCTION: Children exposed to secondhand smoke (SHS) are at increased risk of respiratory illnesses. We piloted a Smoke Free Intervention (SFI) and trial methods before investigating its effectiveness and cost-effectiveness in primary school children. METHODS: In a pilot cluster randomized controlled trial in Bangladesh, primary schools were allocated to usual education (control) or SFI, using minimization. Year-5 children were recruited. Masking treatment allocation was not possible. Delivered by schoolteachers, SFI consisted of two 45-min and four 15-min educational sessions. Our primary outcome was SHS exposure at two months post randomization, verified by children's salivary cotinine. The trial is registered at ISRCTN.com; ISRCTN68690577. RESULTS: Between April 1, 2015 and June 30, 2015, we recruited 12 schools. Of the 484 children present in Year-5, 481 consented. Six schools were allocated to both SFI (n = 245) and to usual education only (n = 236). Of them, 450 children (SFI = 229; control = 221) who had cotinine levels indicative of SHS exposure were followed-up. All schools were retained, 91% children (208/229) in SFI and 88% (194/221) in the control arm completed primary outcome assessment. Their mean cotinine at the cluster level was 0.53 ng/ml (SD 0.36) in SFI and 1.84 ng/ml (SD 1.49) in the control arm-a mean difference of -1.31 ng/ml (95% CI = -2.86 to 0.24). CONCLUSION: It was feasible to recruit, randomize, and retain primary schools and children in our trial. Our study, though not powered to detect differences in mean cotinine between the two arms, provides estimates to inform the likely effect size for future trials. IMPLICATIONS: In countries with high smoking prevalence, children remain at risk of many conditions due to secondhand smoke exposure. There is little empirical evidence on the effectiveness and cost-effectiveness of interventions that can reduce their exposure to secondhand smoke at homes. CLASS II trial found that a school-based intervention (SFI) has the potential to reduce children's exposure to SHS-an approach that has been rarely used, but has considerable merit in school-based contexts. CLASS II trial provides key information to conduct a future definitive trial in this area of public health, which despite its importance has so far received little attention.

Engaging Gypsy, Roma, and Traveller Communities in Research: Maximizing Opportunities and Overcoming Challenges.

Gypsy, Roma, and Traveller people are marginalized worldwide and experience severe health inequalities, even in comparison to other ethnic minority groups. While diverse and hard to categorize, these communities are highly cohesive and members have a strong sense of identity as a group apart from the majority population. Researchers commonly experience challenges in accessing, recruiting, and retaining research participants from these communities, linked to their outsider status, insular nature, and history of discrimination. In this article, the challenges and the opportunities of engaging Gypsies, Roma, and Travellers in a multicenter qualitative research project are discussed. The management of public involvement and community engagement in this U.K.-based project provides insights into conducting research effectively with ethnically and linguistically diverse communities, often considered to be "hard to reach."

Gypsy, Roma and Traveller access to and engagement with health services: a systematic review.

Background: Gypsy, Roma and Traveller people represent the most disadvantaged minority groups in Europe, having the poorest health outcomes. This systematic review addressed the question of how Gypsy, Roma and Traveller people access healthcare and what are the best ways to enhance their engagement with health services. Methods: Searches were conducted in 21 electronic databases complemented by a focussed Google search. Studies were included if they had sufficient focus on Gypsy, Roma or Traveller populations; reported data pertinent to healthcare service use or engagement and were published in English from 2000 to 2015. Study findings were analyzed thematically and a narrative synthesis reported. Results: Ninety-nine studies from 32 countries were included, covering a range of health services. Nearly one-half of the presented findings related to primary healthcare services. Reported barriers to health service usage related to organisation of health systems, discrimination, culture and language, health literacy, service-user attributes and economic barriers. Promising engagement strategies included specialist roles, outreach services, dedicated services, raising health awareness, handheld records, training for staff and collaborative working. Conclusion: This review provides evidence that Gypsy, Roma and Traveller populations across Europe struggle to exercise their right to healthcare on account of multiple barriers; and related to other determinants of disadvantage such as low literacy levels and experiences of discrimination. Some promising strategies to overcome barriers were reported but the evidence is weak; therefore, rigorous evaluations of interventions to improve access to and engagement with health services for Gypsy, Roma and Traveller people are needed.

Behaviour change interventions to reduce second-hand smoke exposure at home in pregnant women - a systematic review and intervention appraisal.

BACKGROUND: Second-hand smoke (SHS) exposure during pregnancy is associated with poor pregnancy and foetal outcomes. Theory-based behaviour change interventions (BCI) have been used successfully to change smoking related behaviours and offer the potential to reduce exposure of SHS in pregnant women. Systematic reviews conducted so far do not evaluate the generalisability and scalability of interventions. The objectives of this review were to (1) report the BCIs for reduction in home exposure to SHS for pregnant women; and (2) critically appraise intervention-reporting, generalisability, feasibility and scalability of the BCIs employed. METHODS: Standard methods following PRISMA guidelines were employed. Eight databases were searched from 2000 to 2015 in English. The studies included used BCIs on pregnant women to reduce their home SHS exposure by targeting husbands/partners. The Workgroup for Intervention Development and Evaluation Research (WIDER) guidelines were used to assess intervention reporting. Generalisability, feasibility and scalability were assessed against criteria described by Bonell and Milat. RESULTS: Of 3479 papers identified, six studies met the inclusion criteria. These studies found that BCIs led to increased knowledge about SHS harms, reduction or husbands quitting smoking, and increased susceptibility and change in level of actions to reduce SHS at home. Two studies reported objective exposure measures, and one reported objective health outcomes. The studies partially followed WIDER guidelines for reporting, and none met all generalisability, feasibility and scalability criteria. CONCLUSIONS: There is a dearth of literature in this area and the quality of studies reviewed was moderate to low. The BCIs appear effective in reducing SHS, however, weak study methodology (self-reported exposure, lack of objective outcome assessment, short follow-up, absence of control group) preclude firm conclusion. Some components of the WIDER checklist were followed for BCI reporting, scalability and feasibility of the studies were not described. More rigorous studies using biochemical and clinical measures for exposures and health outcomes in varied study settings are required. Studies should report interventions in detail using WIDER checklist and assess them for generalisability, feasibility and scalability. TRIAL REGISTRATION: CRD40125026666.

Needles, Jabs and Jags: a qualitative exploration of barriers and facilitators to child and adult immunisation uptake among Gypsies, Travellers and Roma.

BACKGROUND: Gypsies, Travellers and Roma (referred to as Travellers) are less likely to access health services including immunisation. To improve immunisation rates, it is necessary to understand what helps and hinders individuals in these communities in taking up immunisations. This study had two aims. 1. Investigate the views of Travellers in the UK on the barriers and facilitators to acceptability and uptake of immunisations and explore their ideas for improving immunisation uptake; 2. Examine whether and how these responses vary across and within communities, and for different vaccines (childhood and adult). METHODS: This was a qualitative, cross-sectional interview study informed by the Social Ecological Model. Semi-structured interviews were conducted with 174 Travellers from six communities: Romanian Roma, English Gypsy/Irish Travellers (Bristol), English Gypsy (York), Romanian/Slovakian Roma, Scottish Show people (Glasgow) and Irish Traveller (London). The focus was childhood and selected adult vaccines. Data were analysed using the Framework approach. RESULTS: Common accounts of barriers and facilitators were identified across all six Traveller communities, similar to those documented for the general population. All Roma communities experienced additional barriers of language and being in a new country. Men and women described similar barriers and facilitators although women spoke more of discrimination and low literacy. There was broad acceptance of childhood and adult immunisation across and within communities, with current parents perceived as more positive than their elders. A minority of English-speaking Travellers worried about multiple/combined childhood vaccines, adult flu and whooping cough and described barriers to booking and attending immunisation. Cultural concerns about antenatal vaccines and HPV vaccination were most evident in the Bristol English Gypsy/Irish Traveller community. Language, literacy, discrimination, poor school attendance, poverty and housing were identified as barriers across different communities. Trustful relationships with health professionals were important and continuity of care valued. CONCLUSIONS: The experience of many Travellers in this study, and the context through which they make health decisions, is changing. This large study identified key issues that should be considered when taking action to improve uptake of immunisations in Traveller families and reduce the persistent inequalities in coverage. TRIAL REGISTRATION: Current Controlled Trials ISRCTN20019630 .

How is success achieved by individuals innovating for patient safety and quality in the NHS?

BACKGROUND: Innovation in healthcare is said to be notoriously difficult to achieve and sustain yet simultaneously the health service is under intense pressure to innovate given the ever increasing demands placed upon it. Whilst many studies have looked at diffusion of innovation from an organisational perspective, few have sought to understand how individuals working in healthcare innovate successfully. We took a positive deviance approach to understand how innovations are achieved by individuals working in the NHS. METHOD: We conducted in depth interviews in 2015 with 15 individuals who had received a national award for being a successful UK innovator in healthcare. We invited only those people who were currently (or had recently) worked in the NHS and whose innovation focused on improving patient safety or quality. Thematic analysis was used. FINDINGS: Four themes emerged from the data: personal determination, the ability to broker relationships and make connections, the ways in which innovators were able to navigate organisational culture to their advantage and their ability to use evidence to influence others. Determination, focus and persistence were important personal characteristics of innovators as were skills in being able to challenge the status quo. Innovators were able to connect sometimes disparate teams and people, being the broker between them in negotiating collaborative working. The culture of the organisation these participants resided in was important with some being able to use this (and the current patient safety agenda) to their advantage. Gathering robust data to demonstrate their innovation had a positive impact and was seen as essential to its progression. CONCLUSIONS: This paper reveals a number of factors which are important to the success of innovators in healthcare. We have uncovered that innovators have particular personal traits which encourage a propensity towards change and action. Yet, for fruitful innovation to take place, it is important for relational networks and organisational culture to be receptive to change.

Community engagement to enhance trust between Gypsy/Travellers, and maternity, early years' and child dental health services: protocol for a multi-method exploratory study.

BACKGROUND: Gypsy/Travellers have poor health and experience discrimination alongside structural and cultural barriers when accessing health services and consequently may mistrust those services. Our study aims to investigate which approaches to community engagement are most likely to be effective at enhancing trust between Gypsy/Travellers and mainstream health services. METHODS: This multi-method 30-month study, commenced in June 2015, and comprises four stages. 1. Three related reviews: a) systematic review of Gypsy/Travellers' access to health services; b) systematic review of reviews of how trust has been conceptualised within healthcare; c) realist synthesis of community engagement approaches to enhance trust and increase Gypsy/Travellers' participation in health services. The reviews will consider any economic literature; 2. Online consultation with health and social care practitioners, and civil society organisations on existing engagement activities, including perceptions of barriers and good practice; 3. Four in-depth case studies of different Gypsy/Traveller communities, focusing on maternity, early years and child dental health services. The case studies include the views of 32-48 mothers of pre-school children, 32-40 healthcare providers and 8-12 informants from third sector organisations. 4. Two stakeholder workshops exploring whether policy options are realistic, sustainable and replicable. Case study data will be analysed thematically informed by the evaluative framework derived from the realist synthesis in stage one. The main outputs will be: a) an evaluative framework of Gypsy/Travellers' engagement with health services; b) recommendations for policy and practice; c) evidence on which to base future implementation strategies including estimation of costs. DISCUSSION: Our novel multi-method study seeks to provide recommendations for policy and practice that have potential to improve uptake and delivery of health services, and to reduce lifetime health inequalities for Gypsy/Travellers. The findings may have wider resonance for other marginalised populations. Strengths and limitations of the study are discussed. TRIAL REGISTRATION: Prospero registration for literature reviews: CRD42015021955 and CRD42015021950 UKCRN reference: 20036.

Behaviour change intervention for smokeless tobacco cessation: its development, feasibility and fidelity testing in Pakistan and in the UK.

BACKGROUND: People of South Asian-origin are responsible for more than three-quarters of all the smokeless tobacco (SLT) consumption worldwide; yet there is little evidence on the effect of SLT cessation interventions in this population. South Asians use highly addictive and hazardous SLT products that have a strong socio-cultural dimension. We designed a bespoke behaviour change intervention (BCI) to support South Asians in quitting SLT and then evaluated its feasibility in Pakistan and in the UK. METHODS: We conducted two literature reviews to identify determinants of SLT use among South Asians and behaviour change techniques (BCTs) likely to modify these, respectively. Iterative consensus development workshops helped in selecting potent BCTs for BCI and designing activities and materials to deliver these. We piloted the BCI in 32 SLT users. All BCI sessions were audiotaped and analysed for adherence to intervention content and the quality of interaction (fidelity index). In-depth interviews with16 participants and five advisors assessed acceptability and feasibility of delivering the BCI, respectively. Quit success was assessed at 6 months by saliva/urine cotinine. RESULTS: The BCI included 23 activities and an interactive pictorial resource that supported these. Activities included raising awareness of the harms of SLT use and benefits of quitting, boosting clients' motivation and self-efficacy, and developing strategies to manage their triggers, withdrawal symptoms, and relapse should that occur. Betel quid and Guthka were the common forms of SLT used. Pakistani clients were more SLT dependent than those in the UK. Out of 32, four participants had undetectable cotinine at 6 months. Fidelity scores for each site varied between 11.2 and 42.6 for adherence to content - maximum score achievable 44; and between 1.4 and 14 for the quality of interaction - maximum score achievable was 14. Interviews with advisors highlighted the need for additional training on BCTs, integrating nicotine replacement and reducing duration of the pre-quit session. Clients were receptive to health messages but most reported SLT reduction rather than complete cessation. CONCLUSION: We developed a theory-based BCI that was also acceptable and feasible to deliver with moderate fidelity scores. It now needs to be evaluated in an effectiveness trial.

A systematic review of research into black and ethnic minority patients' views on self-management of type 2 diabetes.

CONTEXT: Eliciting patients' views of type 2 diabetes self-management provides insights on how policy and services might better support the needs of this population. OBJECTIVE: To synthesize black and ethnic minority patients' views on the barriers and facilitators influencing the self-management of type 2 diabetes. SEARCH STRATEGY: A systematic search of international literature published in nine electronic databases was undertaken in 2008. Search strategies used both MeSH and free-text terms. Two relevant journals were also hand searched. INCLUSION CRITERIA: Any primary empirical study published in the English language since 1986 that reported black and ethnic minority patients' views on type 2 diabetes self-management. DATA EXTRACTION AND SYNTHESIS: Data were extracted and study quality was formally assessed. Data were analysed using thematic synthesis. MAIN RESULTS: Fifty-seven studies were included, of qualitative (n = 54), mixed-method (n = 2) or quantitative (n = 1) design. Studies were from North America (n = 41), Europe (n = 14) and Australia (n = 2), including 1735 participants in total. Three analytical themes emerged: 'Importance of identity'; 'Being understood by others' and 'Making sense of condition', all linked conceptually under the overarching theme 'Sense of self'. The quality of the studies varied. DISCUSSION AND CONCLUSIONS: The findings provide insight into what black and minority ethnic people regard as the barriers to, and facilitators of self-management, as opposed to what health professionals, policy makers and trial researchers may have assumed. Recognition of the views of people with diabetes is essential for the design and delivery of patient-centred care and policies.

Intervention fidelity and effectiveness of a UK worksite physical activity intervention funded by the BUPA Foundation, UK.

The main aim of this study was to test whether the effectiveness of a worksite physical activity intervention delivered in five work organizations varied as a function of intervention fidelity. We conducted a fidelity analysis as part of a large matched-pair cluster randomized controlled trial of a worksite physical activity intervention (AME for Activity). Participants (N = 1260) were employees from five organizations in the UK. The primary trial outcome was physical activity at 9 months post intervention. Adherence, exposure, quality of delivery and participant responsiveness/engagement were measured to assess fidelity. Qualitative data about the context in which the intervention was delivered were collected via focus groups, interviews and field notes. Multi-level modelling was used to provide a comparison of the effect of the intervention on increases in physical activity for worksites where intervention fidelity was good, compared with those where intervention fidelity was poor or moderate. Intervention fidelity was poor in two organizations, moderate in two organizations and good in one organization (local council). Re-analysis of the trial data comparing employees in the local council (N = 443) with employees in all other worksites (N = 611) revealed a significant effect of the intervention on physical activity levels among council employees only. These findings suggest that the measurement of fidelity and the testing of the effects of intervention fidelity on outcomes, as part of the evaluation of complex interventions, are essential to understand the context and conditions in which interventions are most effective.