Contraceptive and pregnancy concerns in the UK during the first COVID-19 lockdown: A rapid study.

OBJECTIVES: COVID-19 resulted in significant disruption to sexual and reproductive health (SRH) services globally and the impact of this remains under explored. This study aimed to explore the impact of COVID-19 on SRH during the initial weeks of the first UK lockdown. DESIGN: This rapid study employed a cross-sectional anonymous survey design. Between 9th April and 4th May 2020, participants completed an online questionnaire around the impacts of COVID-19 on SRH. The survey was completed by 194 participants. The findings in this paper, report on data from closed and free text questions from 32% (n = 62) of the total sample who said they were able to get pregnant. RESULTS: Participants raised concerns around reduced access to, or a denial of, SRH services as well as reduced choice when such services were available. Participants felt their right to access SRH care was impinged and there were anxieties around the impact of COVID-19 on maternal and foetal health. CONCLUSIONS: The study contributes to a better understanding of the concerns, during the first 8 weeks of the UK lockdown, of those who could get pregnant. Policy makers and planners must ensure that SRH policy, that recognises the importance of bodily autonomy and rights, is central to pandemic planning and responses both in the UK and globally. Such policies should ensure the immediate implementation of protocols that protect SRH service delivery, alongside informing service users of both their right to access such care and how to do so. Further work is necessary with members from minority communities who are mostly absent from this study to explore if, and how, COVID-19 may have exacerbated already existing disparities.

A first step towards best practice recommendations for the design and statistical analyses of pragmatic clinical trials: A modified Delphi approach.

AIM: Pragmatic clinical trials (PCTs) are randomized trials implemented through routine clinical practice, where design parameters of traditional randomized controlled trials are modified to increase generalizability. However, this may introduce statistical challenges. We aimed to identify these challenges and discuss possible solutions leading to best practice recommendations for the design and analysis of PCTs. METHODS: A modified Delphi method was used to reach consensus among a panel of 11 experts in clinical trials and statistics. Statistical issues were identified in a focused literature review and aggregated with insights and possible solutions from experts collected through a series of survey iterations. Issues were ranked according to their importance. RESULTS: Twenty-seven articles were included and combined with experts' insight to generate a list of issues categorized into participants, recruiting sites, randomization, blinding and intervention, outcome (selection and measurement) and data analysis. Consensus was reached about the most important issues: risk of participants' attrition, heterogeneity of "usual care" across sites, absence of blinding, use of a subjective endpoint and data analysis aligned with the trial estimand. Potential issues should be anticipated and preferably be addressed in the trial protocol. The experts provided solutions regarding data collection and data analysis, which were considered of equal importance. DISCUSSION: A set of important statistical issues in PCTs was identified and approaches were suggested to anticipate and/or minimize these through data analysis. Any impact of choosing a pragmatic design feature should be gauged in the light of the trial estimand.

Improving Our Understanding and Practice of Antibiotic Prescribing: A Study on the Use of Social Norms Feedback Letters in Primary Care.

In the UK, 81% of all antibiotics are prescribed in primary care. Previous research has shown that a letter from the Chief Medical Officer (CMO) giving social norms feedback to General Practitioners (GPs) whose practices are high prescribers of antibiotics can decrease antibiotic prescribing. The aim of this study was to understand the best way for engaging with GPs to deliver feedback on prescribing behaviour that could be replicated at scale; and explore GP information requirements that would be needed to support prescribing behaviour change. Two workshops were devised utilising a participatory approach. Discussion points were noted and agreed with each group of participants. Minutes of the workshops and observation notes were taken. Data were analysed thematically. Four key themes emerged through the data analysis: (1) Our day-to-day reality, (2) GPs are competitive, (3) Face-to-face support, and (4) Empowerment and engagement. Our findings suggest there is potential for using behavioural science in the form of social norms as part of a range of engagement strategies in reducing antibiotic prescribing within primary care. This should include tailored and localised data with peer-to-peer comparisons.

Implementation of a "real-world" learning health system: Results from the evaluation of the Connected Health Cities programme.

BACKGROUND: The "learning health system" has been proposed to deliver better outcomes for patients and communities by analyzing routinely captured health information and feeding back results to clinical staff. This approach has been piloted in the Connected Health Cities (CHC) programme in four regions in the North of England. This paper presents the results of the evaluation of this program conducted between February and December 2018. METHODS: Fifty nine semistructured interviews were completed with a mix of CHC programme staff and external partners who had contributed to the delivery of the CHC programme. Interviews were audio recorded and transcribed verbatim. This also included the review of project documentation including project reports and minutes of project group meetings, in addition to a short online survey that was completed by 31 members of CHC programme staff. Data were analyzed thematically. RESULTS: Two overarching themes emerged through the thematic analysis of participant interview: (a) challenges in the implementation of learning health system pathways, and (b) benefits to the CHC approach for both staff and patients. In particular, time constraints in delivering an ambitious program of work, data quality, and accessibility, as well as the long-term sustainability of the CHC programme were noted as key challenges in implementing a LHS at scale. CONCLUSIONS: The findings from this evaluation provide valuable insight into creating learning health system at scale, including the potential benefits and likely challenges.

European-wide policymaking at the urban level: a qualitative study.

BACKGROUND: Inter-urban area (UA) health inequalities can be as dramatic as those between high and low-income countries. Policies need to focus on the determinants of health specific to UAs to effect change. This study therefore aimed to determine the degree to which policymakers from different countries could make autonomous health and wellbeing policy decisions for their urban jurisdiction area. METHODS: We conducted a cross-sectional, qualitative interview study with policymakers recruited from eight European countries (N = 37). RESULTS: The reported autonomy among policymakers varied considerably between countries, from little or no autonomy and strict adherence to national directives (e.g. Slovak Republic) to a high degree of autonomy and ability to interpret national guidelines to local context (e.g. Norway). The main perceived barriers to implementation of local policies were political, and the importance of regular and effective communication with stakeholders, especially politicians, was emphasized. Having qualified health professionals in positions of influence within the UA was cited as a strong driver of the public health (PH) agenda at the UA level. CONCLUSION: Local-level policy development and implementation depends strongly on the degree of autonomy and independence of policymakers, which in turn depends on the organization, structure and financial budget allocation of PH services. While high levels of centralization in small, relatively homogenous countries may enhance efficient use of resources, larger, more diverse countries may benefit from devolution to smaller geographical regions.

Correction to: The role of real-world data in the development of treatment guidelines: a case study on guideline developers' opinions about using observational data on antibiotic prescribing in primary care.

An amendment to this paper has been published and can be accessed via the original article.

The role of real-world data in the development of treatment guidelines: a case study on guideline developers' opinions about using observational data on antibiotic prescribing in primary care.

BACKGROUND: Antimicrobial resistance (AMR) is a prominent threat to public health. Although many guidelines have been developed over the years to tackle this issue, their impact on health care practice varies. Guidelines are often based on evidence from clinical trials, but these have limitations, particularly in the breadth and generalisability of the evidence and evaluation of the guidelines' uptake. The aim of this study was to investigate how national and local guidelines for managing common infections are developed and explore guideline committee members' opinions about using real-world observational evidence in the guideline development process. METHODS: Six semi-structured interviews were completed with participants who had contributed to the development or adjustment of national or local guidelines on antimicrobial prescribing over the past 5 years (from the English National Institute for Health and Care Excellence (NICE)). Interviews were audio recorded and transcribed verbatim. Data was analysed thematically. This also included review of policy documents including guidelines, reports and minutes of guideline development group meetings that were available to the public. RESULTS: Three key themes emerged through our analysis: perception versus actual guideline development process, using other types of evidence in the guideline development process, and guidelines are not enough to change antibiotic prescribing behaviour. In addition, our study was able to provide some insight between the documented and actual guideline development process within NICE, as well as how local guidelines are developed, including differences in types of evidence used. CONCLUSIONS: This case study indicates that there is the potential for a wider range of evidence to be included as part of the guideline development process at both the national and local levels. There was a general agreement that the inclusion of observational data would be appropriate in enhancing the guideline development process, as well providing a potential solution for monitoring guideline use in clinical practice, and improving the implementation of treatment guidelines in primary care.

Evaluation protocol of the implementation of a learning healthcare system in clinical practice: the Connected Health Cities programme in the north of England.

INTRODUCTION: The 'learning healthcare system' (LHS) has been proposed to deliver better outcomes for patients and communities by analysing routinely captured health information and feeding back results to clinical staff. This approach is being piloted in the Connected Health Cities (CHC) programme in four regions in the north of England. This article describes the protocol of the evaluation of this programme. METHODS AND ANALYSIS: In designing this evaluation, we had to take a pragmatic approach to ensure the feasibility of completing the work within 1 year. Furthermore, we have designed the evaluation in such a way as to be able to capture differences in how each of the CHC regions uses a variety of methods to create their own LHS. A mixed methods approach has been adopted for this evaluation due the scale and complexities of the pilot study. A documentary review will identify how CHC pilot study deliverables were operationalised. To gain a broad understanding of CHC staff experiences, an online survey will be offered to all staff to complete. Semi-structured interviews with key programme staff will be used to gain a deeper understanding of key achievements, as well as how challenges have been overcome or managed. Our data analysis will triangulate the documentary review, survey and interview data. A thematic analysis using our logic model as a framework will also be used to assess progress against the CHC programme deliverables and to identify recommendations to support future programme decision-making. ETHICS AND DISSEMINATION: Ethical approval was granted by The University of Manchester Ethics Committee on 24 May 2018. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media, the internet and various stakeholder/patient and public engagement activities.

Systematic review and meta-analysis of pre-hospital diagnostic accuracy studies.

INTRODUCTION: Paramedics are involved in examining, treating and diagnosing patients. The accuracy of these diagnoses is evaluated using diagnostic accuracy studies. We undertook a systematic review of published literature to provide an overview of how accurately paramedics diagnose patients compared with hospital doctors. A bivariate meta-analysis was incorporated to examine the range of diagnostic sensitivity and specificity. METHODS: We searched MEDLINE, CINAHL, Embase, AMED and the Cochrane Database from 1946 to 7 May 2016 for studies where patients had been given a diagnosis by paramedics and hospital doctors. Keywords focused on study type ('diagnostic accuracy'), outcomes (sensitivity, specificity, likelihood ratio?, predictive value?) and setting (paramedic*, pre-hospital, ambulance, 'emergency service?', 'emergency medical service?', 'emergency technician?'). RESULTS: 2941 references were screened by title and/or abstract. Eleven studies encompassing 384 985 patients were included after full-text review. The types of diagnoses in one of the studies encompassed all possible diagnoses and in the other studies focused on sepsis, stroke and myocardial infarction. Sensitivity estimates ranged from 32% to 100% and specificity estimates from 14% to 100%. Eight of the studies were deemed to have a low risk of bias and were incorporated into a meta-analysis which showed a pooled sensitivity of 0.74 (0.62 to 0.82) and a pooled specificity of 0.94 (0.87 to 0.97). DISCUSSION: Current published research suggests that diagnoses made by paramedics have high sensitivity and even higher specificity. However, the paucity and varying quality of studies indicates that further prehospital diagnostic accuracy studies are warranted especially in the field of non-life-threatening conditions. PROSPERO REGISTRATION NUMBER: CRD42016039306.

Developing a typology of mobile phone usage in social care: A critical review of the literature.

The ways in which mobile phones have transformed the boundaries of time and space and the possibilities of communication have profoundly affected our lives. However, there is little research on the use of mobiles in social care though evidence is emerging that mobile phones can play an important role in delivering services. This paper is based on a scoping review of the international literature in this area. A typology of mobile interventions is suggested. While most mobile phone interventions remain unidirectional and sit within traditional social care service provider-service user relationships, a minority are bi- or multidirectional and contain within them the potential to transform these traditional relationships by facilitating a collective development of social networks and social capital. Such transformations are accompanied by a range of issues and dilemmas that have made many service providers reluctant to engage with new technologies. We suggest that our typology is a useful model to draw on when researching the use of mobile phones in social care to support and empower isolated, marginalised and vulnerable service users.

Collecting standardised urban health indicator data at an individual level for adults living in urban areas: methodology from EURO-URHIS 2.

Background: An aim of the EURO-URHIS 2 project was to collect standardised data on urban health indicators (UHIs) relevant to the health of adults resident in European urban areas. This article details development of the survey instruments and methodologies to meet this aim. 32 urban areas from 11 countries conducted the adult surveys. Using a participatory approach, a standardised adult UHI survey questionnaire was developed mainly comprised of previously validated questions, followed by translation and back-translation. An evidence-based survey methodology with extensive training was employed to ensure standardised data collection. Comprehensive UK piloting ensured face validity and investigated the potential for response bias in the surveys. Each urban area distributed 800 questionnaires to age-sex stratified random samples of adults following the survey protocols. Piloting revealed lower response rates in younger males from more deprived areas. Almost 19500 adult UHI questionnaires were returned and entered from participating urban areas. Response rates were generally low but varied across Europe. The participatory approach in development of survey questionnaires and methods using an evidence-based approach and extensive training of partners has ensured comparable UHI data across heterogeneous European contexts. The data provide unique information on health and determinants of health in adults living in European urban areas that could be used to inform urban health policymaking. However, piloting has revealed a concern that non-response bias could lead to under-representation of younger males from more deprived areas. This could affect the generalisability of findings from the adult surveys given the low response rates.

The EURO-URHIS 2 project in Ho Chi Min City: contextual adequacy in cross-cultural research.

The European Urban Health Indicators System Project Part 2 (EURO-URHIS 2) is a cross-national study that was implemented in Europe. It consists of four data collection tools that were specifically developed to collect health data at an urban level. This paper reviews some of the methodological constraints in adapting the EURO-URHIS 2 study in Ho Chi Minh City, Vietnam. No attempt to extend the original study beyond Europe has been reported before. Cultural, political, economic and social differences create specific obstacles as well as challenges. This paper sets out how these challenges were addressed, examining key aspects of the methodology, including study design, translation of the questionnaire and data collection. It was found that the EURO-URHIS 2 adult data collection tool methodology could not be replicated in Vietnam. A lack of basic infrastructure and population registers led to significant changes being made to the sampling and survey administration. It was recommended that the Expanded Programme on Immunization (EPI) was used as the replacement method. Despite the limitations in using the EPI method, the overall strengths and benefits were found to address methodological issues and the resource poor setting.