Infection and wound breakdown in spontaneous second-degree perineal tears: An exploratory mixed methods study.

BACKGROUND: Perineal trauma affects large numbers of women who have a vaginal birth. This study explores the incidence, etiology and women's experiences of wound infection/breakdown associated with spontaneous second degree tears. METHODS: This was an exploratory mixed methods study set in an urban tertiary National Health Service hospital in 2014-2015. The study included a prospective observational study of second-degree tears using electronic patient records. Infection was defined using criteria adapted from Public Health England's Surgical Site Infection Surveillance Service. We also did a case-control study of maternity records to explore factors associated with perineal infection/wound breakdown, and semi-structured interviews with a purposeful sample of women who experienced wound infection/breakdown. RESULTS: Of 2892 vaginal births during the study period, 76.8% sustained perineal trauma, with second-degree tears most commonly recorded (n = 828/28.6%). Sixteen (1.9%) had a documented infection/wound breakdown which were associated with "compromised wound status" (increased severity of wound/poor suturing; P = 0.033) Women complained of a lack of information about their perineum and poor postnatal surveillance by midwives and physicians. Diagnosis and treatment were often delayed by clinicians' reliance on external signs of wound infection. Although the sample size was small, there were no differences in rates of infection between sutured and unsutured second-degree tears. CONCLUSIONS: Although second-degree tears were common after vaginal birth, wound infection/breakdown was relatively uncommon. Women who report feeling unwell or develop pyrexia postnatally should be assessed urgently. A prospective longitudinal study exploring the long-term sequelae of second-degree tears is needed

Health Equity Indicators for the English NHS: a longitudinal whole-population study at the small-area level

Background: Inequalities in health-care access and outcomes raise concerns about quality of care and justice, and the NHS has a statutory duty to consider reducing them. Objectives: The objectives were to (1) develop indicators of socioeconomic inequality in health-care access and outcomes at different stages of the patient pathway; (2) develop methods for monitoring local NHS equity performance in tackling socioeconomic health-care inequalities; (3) track the evolution of socioeconomic health-care inequalities in the 2000s; and (4) develop ‘equity dashboards’ for communicating equity findings to decision-makers in a clear and concise format. Design: Longitudinal whole-population study at the small-area level. Setting: England from 2001/2 to 2011/12. Participants: A total of 32,482 small-area neighbourhoods (lower-layer super output areas) of approximately 1500 people. Main outcome measures: Slope index of inequality gaps between the most and least deprived neighbourhoods in England, adjusted for need or risk, for (1) patients per family doctor, (2) primary care quality, (3) inpatient hospital waiting time, (4) emergency hospitalisation for chronic ambulatory care-sensitive conditions, (5) repeat emergency hospitalisation in the same year, (6) dying in hospital, (7) mortality amenable to health care and (8) overall mortality. Data sources: Practice-level workforce data from the general practice census (indicator 1), practice-level Quality and Outcomes Framework data (indicator 2), inpatient hospital data from Hospital Episode Statistics (indicators 3–6) and mortality data from the Office for National Statistics (indicators 6–8). Results: Between 2004/5 and 2011/12, more deprived neighbourhoods gained larger absolute improvements on all indicators except waiting time, repeat hospitalisation and dying in hospital. In 2011/12, there was little measurable inequality in primary care supply and quality, but inequality was associated with 171,119 preventable hospitalisations and 41,123 deaths amenable to health care. In 2011/12, > 20% of Clinical Commissioning Groups performed statistically significantly better or worse than the England equity benchmark. Limitations: General practitioner supply is a limited measure of primary care access, need in deprived neighbourhoods may be underestimated because of a lack of data on multimorbidity, and the quality and outcomes indicators capture only one aspect of primary care quality. Health-care outcomes are adjusted for age and sex but not for other risk factors that contribute to unequal health-care outcomes and may be outside the control of the NHS, so they overestimate the extent of inequality for which the NHS can reasonably be held responsible. Conclusions: NHS actions can have a measurable impact on socioeconomic inequality in both health-care access and outcomes. Reducing inequality in health-care outcomes is more challenging than reducing inequality of access to health care. Local health-care equity monitoring against a national benchmark can be performed using any administrative geography comprising ≥ 100,000 people

Preconception care for women with type 1 or type 2 diabetes mellitus: a mixed-methods study exploring uptake of preconception care

Background: Diabetes mellitus is a global health problem and one of the most common medical conditions in pregnancy. A wide range of modifiable risk factors are associated with diabetes mellitus in pregnancy, and it is widely acknowledged that preconception care (PCC) is beneficial for women with pre-existing diabetes mellitus. However, uptake of PCC services is low. Objectives: To systematically review qualitative research on PCC for women with pre-existing diabetes mellitus of childbearing age, identify facilitators of and barriers to uptake of PCC and establish themes and gaps in knowledge. Through qualitative interviews explore views on the provision of, and facilitators of and barriers to the uptake of, PCC. Design: Mixed methods encompassing a systematic review and qualitative interviews. Setting: Two secondary care sites and 11 primary care sites. Participants: Women of childbearing age with pre-existing type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) of white British or Pakistani origin. Interventions: None. Analysis: A narrative synthesis of the literature using thematic analysis and a thematic analysis of the qualitative interview data using the method of constant comparison. Results: Eighteen qualitative studies were included in the systematic review and a quality appraisal was carried out using relevant criteria for qualitative research appraisal, including a narrative summary of study quality. Twelve interviews with women with pre-existing T1DM or T2DM were carried out. This fell short of the original aim of interviewing 48 women owing to challenges in recruitment, especially in primary care. A synthesis of these data shows that uptake of PCC is influenced by a range of factors, including the complexity of pregnancy planning, the skill and expertise of health professionals who provide care to women with diabetes mellitus, the role of health professionals in the delivery of PCC, and the quality of relationships between women and health professionals. Limitations: Owing to significant challenges with recruitment of participants, particularly in primary care, 12 interviews with women with pre-existing T1DM or T2DM were carried out, which fell short of the a priori sample size. Conclusions: Reconceptualising PCC to place greater emphasis on pregnancy planning, fertility and contraception would lower some of the existing barriers to uptake of care. It is important to clarify who is responsible for the delivery of PCC to women with pre-existing diabetes mellitus and to ensure that the correct expertise is available so that opportunities for advice giving are maximised. Relationships between women and health professionals should be based on a partnership approach that encourages mutual trust and respect, focusing on positive change rather than negative outcomes. Future work: Further research is needed to investigate the views and experiences of stakeholders that commission, design and deliver PCC services for women with pre-existing diabetes mellitus; to explore experiences of women from minority or ethnically diverse backgrounds; to investigate the role of family support in contraception, pregnancy planning and PCC; and to investigate the management of diabetes mellitus in neonatal care and its role in breastfeeding. Study registration: This study is registered as PROSPERO CRD42014015592 and ISRCTN12983949. Funding: The National Institute for Health Research Health Technology Assessment programme

Evidence for models of diagnostic service provision in the community: literature mapping exercise and focused rapid reviews

Background Current NHS policy favours the expansion of diagnostic testing services in community and primary care settings. Objectives Our objectives were to identify current models of community diagnostic services in the UK and internationally and to assess the evidence for quality, safety and clinical effectiveness of such services. We were also interested in whether or not there is any evidence to support a broader range of diagnostic tests being provided in the community. Review methods We performed an initial broad literature mapping exercise to assess the quantity and nature of the published research evidence. The results were used to inform selection of three areas for investigation in more detail. We chose to perform focused reviews on logistics of diagnostic modalities in primary care (because the relevant issues differ widely between different types of test); diagnostic ultrasound (a key diagnostic technology affected by developments in equipment); and a diagnostic pathway (assessment of breathlessness) typically delivered wholly or partly in primary care/community settings. Databases and other sources searched, and search dates, were decided individually for each review. Quantitative and qualitative systematic reviews and primary studies of any design were eligible for inclusion. Results We identified seven main models of service that are delivered in primary care/community settings and in most cases with the possible involvement of community/primary care staff. Not all of these models are relevant to all types of diagnostic test. Overall, the evidence base for community- and primary care-based diagnostic services was limited, with very few controlled studies comparing different models of service. We found evidence from different settings that these services can reduce referrals to secondary care and allow more patients to be managed in primary care, but the quality of the research was generally poor. Evidence on the quality (including diagnostic accuracy and appropriateness of test ordering) and safety of such services was mixed. Conclusions In the absence of clear evidence of superior clinical effectiveness and cost-effectiveness, the expansion of community-based services appears to be driven by other factors. These include policies to encourage moving services out of hospitals; the promise of reduced waiting times for diagnosis; the availability of a wider range of suitable tests and/or cheaper, more user-friendly equipment; and the ability of commercial providers to bid for NHS contracts. However, service development also faces a number of barriers, including issues related to staffing, training, governance and quality control. Limitations We have not attempted to cover all types of diagnostic technology in equal depth. Time and staff resources constrained our ability to carry out review processes in duplicate. Research in this field is limited by the difficulty of obtaining, from publicly available sources, up-to-date information about what models of service are commissioned, where and from which providers. Future work There is a need for research to compare the outcomes of different service models using robust study designs. Comparisons of ‘true’ community-based services with secondary care-based open-access services and rapid access clinics would be particularly valuable. There are specific needs for economic evaluations and for studies that incorporate effects on the wider health system. There appears to be no easy way of identifying what services are being commissioned from whom and keeping up with local evaluations of new services, suggesting a need to improve the availability of information in this area. Funding The National Institute for Health Research Health Services and Delivery Research programme

Accessibility and implementation in the UK NHS services of an effective depression relapse prevention programme:learning from mindfulness-based cognitive therapy through a mixed-methods study

Background: Depression affects as many as one in five people in their lifetime and often runs a recurrent lifetime course. Mindfulness-based cognitive therapy (MBCT) is an effective psychosocial approach that aims to help people at risk of depressive relapse to learn skills to stay well. However, there is an ‘implementation cliff’: access to those who could benefit from MBCT is variable and little is known about why that is the case, and how to promote sustainable implementation. As such, this study fills a gap in the literature about the implementation of MBCT. Objectives: To describe the existing provision of MBCT in the UK NHS, develop an understanding of the perceived costs and benefits of MBCT implementation, and explore the barriers and critical success factors for enhanced accessibility. We aimed to synthesise the evidence from multiple data sources to create an explanatory framework of the how and why of implementation, and to co-develop an implementation resource with key stakeholders. Design: A two-phase qualitative, exploratory and explanatory study, which was conceptually underpinned by the Promoting Action on Research Implementation in Health Services framework. Setting: UK NHS services. Methods: Phase 1 involved interviews with participants from 40 areas across the UK about the current provision of MBCT. Phase 2 involved 10 case studies purposively sampled with differing degrees of MBCT provision, and from each UK country. Case study methods included interviews with key stakeholders, including commissioners, managers, MBCT practitioners and teachers, and service users. Observations were conducted and key documents were also collected. Data were analysed using a modified approach to framework analysis. Emerging findings were verified through stakeholder discussions and workshops. Results: Phase 1: access to and the format of MBCT provision across the NHS remains variable. NHS services have typically adapted MBCT to their context and its integration into care pathways was also highly variable even within the same trust or health board. Participants’ accounts revealed stories of implementation journeys that were driven by committed individuals that were sometimes met by management commitment. Phase 2: a number of explanations emerged that explained successful implementation. Critically, facilitation was the central role of the MBCT implementers, who were self-designated individuals who ‘championed’ implementation, created networks and over time mobilised top-down organisational support. Our explanatory framework mapped out a prototypical implementation journey, often over many years. This involved implementers working through grassroots initiatives and over time mobilising top-down organisational support, and a continual fitting of evidence, with the MBCT intervention, contextual factors and the training/supervision of MBCT teachers. Key pivot points in the journey provided windows of challenge or opportunity. Limitations: The findings are largely based on informants’ accounts and, therefore, are at risk of the bias of self-reporting. Conclusions: Although access to MBCT across the UK is improving, it remains very patchy. This study provides an explanatory framework that helps us understand what facilitates and supports sustainable MBCT implementation. Future work: The framework and stakeholder workshops are being used to develop online implementation guidance

Prehospital randomised assessment of a mechanical compression device in out-of-hospital cardiac arrest (PARAMEDIC): a pragmatic, cluster randomised trial and economic evaluation

Background: Mechanical chest compression devices may help to maintain high-quality cardiopulmonary resuscitation (CPR), but little evidence exists for their effectiveness. We evaluated whether or not the introduction of Lund University Cardiopulmonary Assistance System-2 (LUCAS-2; Jolife AB, Lund, Sweden) mechanical CPR into front-line emergency response vehicles would improve survival from out-of-hospital cardiac arrest (OHCA). Objective: Evaluation of the LUCAS-2 device as a routine ambulance service treatment for OHCA. Design: Pragmatic, cluster randomised trial including adults with non-traumatic OHCA. Ambulance dispatch staff and those collecting the primary outcome were blind to treatment allocation. Blinding of the ambulance staff who delivered the interventions and reported initial response to treatment was not possible. We also conducted a health economic evaluation and a systematic review of all trials of out-of-hospital mechanical chest compression. Setting: Four UK ambulance services (West Midlands, North East England, Wales and South Central), comprising 91 urban and semiurban ambulance stations. Clusters were ambulance service vehicles, which were randomly assigned (approximately 1 : 2) to the LUCAS-2 device or manual CPR. Participants: Patients were included if they were in cardiac arrest in the out-of-hospital environment. Exclusions were patients with cardiac arrest as a result of trauma, with known or clinically apparent pregnancy, or aged < 18 years. Interventions: Patients received LUCAS-2 mechanical chest compression or manual chest compressions according to the first trial vehicle to arrive on scene. Main outcome measures: Survival at 30 days following cardiac arrest; survival without significant neurological impairment [Cerebral Performance Category (CPC) score of 1 or 2]. Results: We enrolled 4471 eligible patients (1652 assigned to the LUCAS-2 device and 2819 assigned to control) between 15 April 2010 and 10 June 2013. A total of 985 (60%) patients in the LUCAS-2 group received mechanical chest compression and 11 (< 1%) patients in the control group received LUCAS-2. In the intention-to-treat analysis, 30-day survival was similar in the LUCAS-2 (104/1652, 6.3%) and manual CPR groups [193/2819, 6.8%; adjusted odds ratio (OR) 0.86, 95% confidence interval (CI) 0.64 to 1.15]. Survival with a CPC score of 1 or 2 may have been worse in the LUCAS-2 group (adjusted OR 0.72, 95% CI 0.52 to 0.99). No serious adverse events were noted. The systematic review found no evidence of a survival advantage if mechanical chest compression was used. The health economic analysis showed that LUCAS-2 was dominated by manual chest compression. Limitations: There was substantial non-compliance in the LUCAS-2 arm. For 272 out of 1652 patients (16.5%), mechanical chest compression was not used for reasons that would not occur in clinical practice. We addressed this issue by using complier average causal effect analyses. We attempted to measure CPR quality during the resuscitation attempts of trial participants, but were unable to do so. Conclusions: There was no evidence of improvement in 30-day survival with LUCAS-2 compared with manual compressions. Our systematic review of recent randomised trials did not suggest that survival or survival without significant disability may be improved by the use of mechanical chest compression. Future work: The use of mechanical chest compression for in-hospital cardiac arrest, and in specific circumstances (e.g. transport), has not yet been evaluated

Screening for glucose intolerance and development of a lifestyle education programme for prevention of Type 2 diabetes in a population with intellectual disabilities

Background: The prevalence of type 2 diabetes mellitus (T2DM) and of cardiovascular disease (CVD) is believed to be higher among people with intellectual disability (ID) than in the general population. However, research on prevalence and prevention in this population is limited. Objectives: The objectives of this programme of work were to establish a programme of research that would significantly enhance the knowledge and understanding of impaired glucose regulation (IGR) and T2DM in people with ID; to test strategies for the early identification of IGR and T2DM in people with ID; and to develop a lifestyle education programme and educator training protocol to promote behaviour change in a population with ID and IGR (or at a high risk of T2DM/CVD). Setting: Leicestershire, UK. Participants: Adults with ID were recruited from community settings, including residential homes and family homes. Adults with mild to moderate ID who had an elevated body mass index (BMI) of ≥ 25 kg/m2 and/or IGR were invited to take part in the education programme. Main outcome measures: The primary outcome of the screening programme was the prevalence of screen-detected T2DM and IGR. The uptake, feasibility and acceptability of the intervention were assessed. Data sources: Participants were recruited from general practices, specialist ID services and clinics, and through direct contact. Results: A total of 930 people with ID were recruited to the screening programme: 58% were male, 80% were white and 68% were overweight or obese. The mean age of participants was 43.3 years (standard deviation 14.2 years). Bloods were obtained for 675 participants (73%). The prevalence of previously undiagnosed T2DM was 1.3% [95% confidence interval (CI) 0.5% to 2%] and of IGR was 5% (95% CI 4% to 7%). Abnormal IGR was more common in those of non-white ethnicity; those with a first-degree family history of diabetes; those with increasing weight, waist circumference, BMI, diastolic blood pressure or triglycerides; and those with lower high-density lipoprotein cholesterol. We developed a lifestyle educational programme for people with ID, informed by findings from qualitative stakeholder interviews (health-care professionals, n = 14; people with ID, n = 7) and evidence reviews. Subsequently, 11 people with ID (and carers) participated in pilot education sessions (two groups) and five people attended education for the feasibility stage (one group). We found that it was feasible to collect primary outcome measures on physical activity and sedentary behaviour using wrist-worn accelerometers. We found that the programme was relatively costly, meaning that large changes in activity or diet (or a reduction in programme costs) would be necessary for the programme to be cost-effective. We also developed a quality development process for assessing intervention fidelity. Limitations: We were able to screen only around 30% of the population and involved only a small number in the piloting and feasibility work. Conclusions: The results from this programme of work have significantly enhanced the existing knowledge and understanding of T2DM and IGR in people with ID. We have developed a lifestyle education programme and educator training protocol to promote behaviour change in this population. Future work: Further work is needed to evaluate the STOP Diabetes intervention to identify cost-effective strategies for its implementation

A cluster randomised trial, cost-effectiveness analysis and psychosocial evaluation of insulin pump therapy compared with multiple injections during flexible intensive insulin therapy for type 1 diabetes: the REPOSE Trial.

BACKGROUND: Insulin is generally administered to people with type 1 diabetes mellitus (T1DM) using multiple daily injections (MDIs), but can also be delivered using infusion pumps. In the UK, pumps are recommended for patients with the greatest need and adult use is less than in comparable countries. Previous trials have been small, of short duration and have failed to control for training in insulin adjustment. OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of pump therapy compared with MDI for adults with T1DM, with both groups receiving equivalent structured training in flexible insulin therapy. DESIGN: Pragmatic, multicentre, open-label, parallel-group cluster randomised controlled trial, including economic and psychosocial evaluations. After participants were assigned a group training course, courses were randomly allocated in pairs to either pump or MDI. SETTING: Eight secondary care diabetes centres in the UK. PARTICIPANTS: Adults with T1DM for > 12 months, willing to undertake intensive insulin therapy, with no preference for pump or MDI, or a clinical indication for pumps. INTERVENTIONS: Pump or MDI structured training in flexible insulin therapy, followed up for 2 years. MDI participants used insulin analogues. Pump participants used a Medtronic Paradigm(®) Veo(TM) (Medtronic, Watford, UK) with insulin aspart (NovoRapid, Novo Nordisk, Gatwick, UK). MAIN OUTCOME MEASURES: Primary outcome - change in glycated haemoglobin (HbA1c) at 2 years in participants whose baseline HbA1c was ≥ 7.5% (58 mmol/mol). Key secondary outcome - proportion of participants with HbA1c ≤ 7.5% at 2 years. Other outcomes at 6, 12 and 24 months - moderate and severe hypoglycaemia; insulin dose; body weight; proteinuria; diabetic ketoacidosis; quality of life (QoL); fear of hypoglycaemia; treatment satisfaction; emotional well-being; qualitative interviews with participants and staff (2 weeks), and participants (6 months); and ICERs in trial and modelled estimates of cost-effectiveness. RESULTS: We randomised 46 courses comprising 317 participants: 267 attended a Dose Adjustment For Normal Eating course (132 pump; 135 MDI); 260 were included in the intention-to-treat analysis, of which 235 (119 pump; 116 MDI) had baseline HbA1c of ≥ 7.5%. HbA1c and severe hypoglycaemia improved in both groups. The drop in HbA1c% at 2 years was 0.85 on pump and 0.42 on MDI. The mean difference (MD) in HbA1c change at 2 years, at which the baseline HbA1c was ≥ 7.5%, was -0.24% [95% confidence interval (CI) -0.53% to 0.05%] in favour of the pump (p = 0.098). The per-protocol analysis showed a MD in change of -0.36% (95% CI -0.64% to -0.07%) favouring pumps (p = 0.015). Pumps were not cost-effective in the base case and all of the sensitivity analyses. The pump group had greater improvement in diabetes-specific QoL diet restrictions, daily hassle plus treatment satisfaction, statistically significant at 12 and 24 months and supported by qualitative interviews. LIMITATION: Blinding of pump therapy was not possible, although an objective primary outcome was used. CONCLUSION: Adding pump therapy to structured training in flexible insulin therapy did not significantly enhance glycaemic control or psychosocial outcomes in adults with T1DM. RESEARCH PRIORITY: To understand why few patients achieve a HbA1c of < 7.5%, particularly as glycaemic control is worse in the UK than in other European countries. TRIAL REGISTRATION: Current Controlled Trials ISRCTN61215213. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 20. See the NIHR Journals Library website for further project information