An integrated understanding of the impact of hospital at home: a mixed-methods study to articulate and test a programme theory.

BACKGROUND: Hospital at Home (HaH) provides intensive, hospital-level care in patients' homes for acute conditions that would normally require hospitalisation, using multidisciplinary teams. As a programme of complex medical-social interventions, a HaH programme theory has not been fully articulated although implicit in the structures, functions, and activities of the existing HaH services. We aimed to unearth the tacit theory from international evidence and test the soundness of it by studying UK HaH services. METHODS: We conducted a literature review (29 articles) adopting a 'realist review' approach (theory articulation) and examined 11 UK-based services by interviewing up to 3 staff members from each service (theory testing). The review and interview data were analysed using Framework Analysis and Purposive Text Analysis. RESULTS: The programme theory has three components- the organisational, utilisation and impact theories. The impact theory consists of key assumptions about the change processes brought about by HaH's activities and functions, as detailed in the organisational and utilisation theories. HaH teams should encompass multiple disciplines to deliver comprehensive assessments and have skill sets for physically delivering hospital-level processes of care in the home. They should aim to treat a broad range of conditions in patients who are clinically complex and felt to be vulnerable to hospital acquired harms. Services should cover 7 days a week, have plans for 24/7 response and deliver relational continuity of care through consistent staffing. As a result, patients' and carers' knowledge, skills, and confidence in disease management and self-care should be strengthened with a sense of safety during HaH treatment, and carers better supported to fulfil their role with minimal added care burden. CONCLUSIONS: There are organisational factors for HaH services and healthcare processes that contribute to better experience of care and outcomes for patients. HaH services should deliver care using hospital level processes through teams that have a focus on holistic and individually tailored care with continuity of therapeutic relationships between professionals and patients and carers resulting in less complexity and fragmentation of care. This analysis informs how HaH services can organise resources and design processes of care to optimise patient satisfaction and outcomes.

Optimising the implementation of evidence-based osteoarthritis guidelines in primary care: Development of a Knowledge Mobilisation Toolkit.

OBJECTIVE: Implementing clinical guidelines for osteoarthritis (OA) in primary care is complex. Whilst international guidelines detail what best practice for OA looks like, little is known about how this is best implemented. Limited resources are available to guideline developers, practitioners, researchers, or the public to facilitate implementation. Set in the context of a larger research project which sought to understand the factors that influence knowledge mobilisation (KM) in implementation for OA guidelines, this study reports the development of a toolkit to optimise KM for the implementation of evidence-based OA guidelines in primary care. DESIGN: Triangulation of three qualitative data sets was conducted, followed by a stakeholder consensus exercise. Public contributors were involved in dedicated meetings (n = 3) to inform the content, design, and KM plans for the toolkit. RESULTS: From data triangulation, 53 key findings were identified, which were refined into 30 draft recommendation statements, within six domains: approaches to KM; the knowledge mobiliser role; understanding context; implementation planning; the nature of the intervention; and appealing to a range of priorities. Stakeholder voting (n = 27) demonstrated consensus with the recommendations and informed the wording of the final toolkit. CONCLUSIONS: Factors that optimise KM for OA guideline implementation in primary care were identified. Empirical data, practice-based evidence, implementation practice, and stakeholder (including patient and public) engagement have informed a toolkit comprising several overarching principles of KM, which are suitable for use in primary care. Consideration of equitable access when implementing evidence-based OA care among diverse populations is recommended when using the toolkit. Further research is needed to evaluate the toolkit's utility and transferability.

Promoting participation in physical activity through Snacktivity: A qualitative mixed methods study.

BACKGROUND: Public health guidance acknowledges the benefits of physical activity of any duration. We have proposed a whole-day approach to promoting physical activity called Snacktivity™, which encourages frequent 2-5 minute 'activity snacks' of moderate-to-vigorous intensity. METHODS: Using repeated semi-structured interviews and a think aloud protocol, this study aimed to understand participants' experiences of integrating Snacktivity™ into daily life, to provide insights to refine the delivery of Snacktivity™ interventions. Physically inactive adults recruited via primary care and a community health service engaged with an intervention to encourage Snacktivity™ over three weeks, which included using a Fitbit and linked mobile phone app (SnackApp). Participants took part in semi-structured interviews on two occasions during the intervention, with a sub-group participating in a think aloud study. Three study data sets were generated and independently explored using inductive thematic analysis, with findings combined into a single set of themes. RESULTS: Eleven adults participated in the interview study who were interviewed twice (total interviews completed n = 21, 1 participant declined the second interview), of whom six completed the think aloud study (total voice recordings n = 103). Three main themes emerged from the combined data; lived experience of participating in Snacktivity™, motivation for Snacktivity™ and experiences with the Snacktivity™ technology. Participants undertook a variety of activity snacks, utilising their environment, which they believed improved their psychological wellbeing. Participants were enthusiastic about Snacktivity™, with some stating that activity snacks were more accessible than traditional exercise, but perceived they were often prevented from doing so in the presence of others. Participants were mostly enthusiastic about using the Snacktivity™ technology. CONCLUSION: Participants were able to incorporate Snacktivity™ into their lives, particularly at home, and found this approach acceptable. Participants felt they experienced health benefits from Snacktivity™ although barriers to participation were reported. This study offers insights for translating guidance into practice and supporting people to become more physically active.

Series: Public engagement with research. Part 4: Maximising the benefits of involving the public in research implementation.

This final article in the four-part series focuses on the often neglected yet important role of the public in implementing research in General Practice and Primary Care more broadly. Experience in implementation of findings from research with public engagement in Primary Care has highlighted how partnership working with patients and the public is important in transitioning from 'what we know' from the evidence-base to 'what we do' in practice. Factors related to Primary Care research that make public engagement important are highlighted e.g. implementing complex interventions, implementing interventions that increase health equity, implementing interventions in countries with different primary healthcare system strengths. Involvement of patients and public can enhance the development of modelling and simulation included in studies on systems modelling for improving health services. We draw on the emerging evidence base to describe public engagement in implementation and offer some guiding principles for engaging with the public in the implementation in General Practice and Primary Care in general. Illustrative case studies are included to support others wishing to offer meaningful engagement in implementing research evidence.

Snacktivity™ to promote physical activity and reduce future risk of disease in the population: protocol for a feasibility randomised controlled trial and nested qualitative study.

BACKGROUND: Many people do not regularly participate in physical activity, which may negatively impact their health. Current physical activity guidelines are focused on promoting weekly accumulation of at least 150 min of moderate to vigorous intensity physical activity (MVPA). Whilst revised guidance now recognises the importance of making small changes to physical activity behaviour, guidance still focuses on adults needing to achieve at least 150 min of MVPA per week. An alternative 'whole day' approach that could motivate the public to be more physically active, is a concept called Snacktivity™. Instead of focusing on achieving 150 min per week of physical activity, for example 30 min of MVPA over 5 days, Snacktivity™ encourages the public to achieve this through small, but frequent, 2-5 min 'snacks' of MVPA throughout the whole day. METHODS: The primary aim is to undertake a feasibility trial with nested qualitative interviews to assess the feasibility and acceptability of the Snacktivity™ intervention to inform the design of a subsequent phase III randomised trial. A two-arm randomised controlled feasibility trial aiming to recruit 80 inactive adults will be conducted. Recruitment will be from health and community settings and social media. Participants will be individually randomised (1:1 ratio) to receive either the Snacktivity™ intervention or usual care. The intervention will last 12 weeks with assessment of outcomes completed before and after the intervention in all participants. We are interested in whether the Snacktivity™ trial is appealing to participants (assessed by the recruitment rate) and if the Snacktivity™ intervention and trial methods are acceptable to participants (assessed by Snacktivity™/physical activity adherence and retention rates). The intervention will be delivered by health care providers within health care consultations or by researchers. Participants' experiences of the trial and intervention, and health care providers' views of delivering the intervention within health consultations will be explored. DISCUSSION: The development of physical activity interventions that can be delivered at scale are needed. The findings from this study will inform the viability and design of a phase III trial to assess the effectiveness and cost-effectiveness of Snacktivity™ to increase physical activity. TRIAL REGISTRATION: ISRCTN: 64851242.

A workshop to co-design messages that may increase uptake of vaccines: A case study.

The present case study describes a co-produced and theoretically informed workshop wherein messages were co-designed to increase the uptake of future COVID-19 vaccines in the United Kingdom. Co-design can enhance the legitimacy and effectiveness of public interventions, but many researchers, service providers, and policymakers may be uncertain where to start. This demonstrative example applies behavioural science and design thinking theory, illustrating how others can integrate theoretically informed co-design into similar and more complex projects efficiently. The workshop brought together members of the public, immunisers, and public health specialists. A narrative analysis was conducted to identify themes related to vaccine hesitancy. The workshop's supporting materials are made available as supplemental materials, which can be modified for future workshops. The discussion encourages additional workshops to be conducted, including diverse members of the public, to co-design novel solutions to improve public health more generally.

Long-term impact of pre-incision antibiotics on children born by caesarean section: a longitudinal study based on UK electronic health records.

BACKGROUND: Since changes in the national guidance in 2011, prophylactic antibiotics for women undergoing caesarean section are recommended prior to skin incision, rather than after the baby's umbilical cord has been clamped. Evidence from randomised controlled trials conducted outside the UK has shown that this reduces maternal infectious morbidity; however, the prophylactic antibiotics also cross the placenta, meaning that babies are exposed to them around the time of birth. Antibiotics are known to affect the gut microbiota of the babies, but the long-term effects of exposure to high-dose broad-spectrum antibiotics around the time of birth on allergy and immune-related diseases are unknown. OBJECTIVES: We aimed to examine whether or not in-utero exposure to antibiotics immediately prior to birth compared with no pre-incisional antibiotic exposure increases the risk of (1) asthma and (2) eczema in children born by caesarean section. DESIGN: This was a controlled interrupted time series study. SETTING: The study took place in primary and secondary care. PARTICIPANTS: Children born in the UK during 2006-18 delivered by caesarean section were compared with a control cohort delivered vaginally. INTERVENTIONS: In-utero exposure to antibiotics immediately prior to birth. MAIN OUTCOME MEASURES: Asthma and eczema in children in the first 5 years of life. Additional secondary outcomes, including other allergy-related conditions, autoimmune diseases, infections, other immune system-related diseases and neurodevelopmental conditions, were also assessed. DATA SOURCES: The Health Improvement Network (THIN) and the Clinical Practice Research Datalink (CPRD) primary care databases and the Hospital Episode Statistics (HES) database. Previously published linkage strategies were adapted to link anonymised data on mothers and babies in these databases. Duplicate practices contributing to both THIN and the CPRD databases were removed to create a THIN-CPRD data set. RESULTS: In the THIN-CPRD and HES data sets, records of 515,945 and 3,945,351 mother-baby pairs were analysed, respectively. The risk of asthma was not significantly higher in children born by caesarean section exposed to pre-incision antibiotics than in children whose mothers received post-cord clamping antibiotics, with an incidence rate ratio of 0.91 (95% confidence interval 0.78 to 1.05) for diagnosis of asthma in primary care and an incidence rate ratio of 1.05 (95% confidence interval 0.99 to 1.11) for asthma resulting in a hospital admission. We also did not find an increased risk of eczema, with an incidence rate ratio of 0.98 (95% confidence interval 0.94 to1.03) and an incidence rate ratio of 0.96 (95% confidence interval 0.71 to 1.29) for diagnosis in primary care and hospital admissions, respectively. LIMITATIONS: It was not possible to ascertain the exposure to pre-incision antibiotics at an individual level. The maximum follow-up of children was 5 years. CONCLUSIONS: There was no evidence that the policy change from post-cord clamping to pre-incision prophylactic antibiotics for caesarean sections during 2006-18 had an impact on the incidence of asthma and eczema in early childhood in the UK. FUTURE WORK: There is a need for further research to investigate if pre-incision antibiotics have any impact on developing asthma and other allergy and immune-related conditions in older children. STUDY REGISTRATION: This study is registered as researchregistry3736. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 30. See the NIHR Journals Library website for further project information.

WHAT WAS THE QUESTION?: Women giving birth by caesarean section are at risk of developing infections (such as wound infections) and are offered antibiotics at the time of their operation to reduce this risk. In 2011, the national guidelines changed from recommending antibiotics after cord clamping to giving them before the operation to further reduce the risk of maternal infection. During birth, the newborn gut is colonised by microbes. Antibiotics given to the mother before caesarean section can reach the baby through the placenta and disrupt the normal microbes that colonise the gut. These microbes are believed to play a role in the development of the immune system and altering the normal development of these microbes has been linked to children developing allergic conditions, such as asthma and eczema. This study investigated whether or not giving antibiotics before the caesarean section had a longer-term impact on children's health. WHAT DID WE DO?: We used routine NHS information already collected by hospitals and general practitioners about women who gave birth in the UK between 2006 and 2018, and their children. We compared the risk of asthma, eczema and other health conditions in the first 5 years after birth in children born by caesarean section before and after the change in hospital policies. We also compared their health with children born vaginally. WHAT DID WE FIND?: We found that there was no increased risk of asthma or eczema for children born by caesarean section after the policy decision in 2011 to give the mother antibiotics before the operation. WHAT DOES THIS MEAN?: The study findings provide further evidence for the current recommendation to give preventative antibiotics to women shortly before the caesarean section to reduce the overall risk of infections after birth.

Evaluating the relationship between moral values and vaccine hesitancy in Great Britain during the COVID-19 pandemic: A cross-sectional survey.

RATIONAL/OBJECTIVE: Mandating vaccinations can harm public trust, and informational interventions can backfire. An alternative approach could align pro-vaccination messages with the automatic moral values and intuitions that vaccine-hesitant people endorse. The current study evaluates the relationships between six automatic moral intuitions and vaccine hesitancy. METHODS: A cross-sectional survey was designed using Qualtrics (2020) software and conducted online from April 6th to April 13, 2021. A representative sample of 1201 people living in Great Britain took part, of which 954 (514 female) passed the attention check items. Participants responded to items about their automatic moral intuitions, vaccination behaviours or intentions related to COVID-19 vaccines, and general vaccine hesitancy. Regressions (with and without adjustments for age, gender, and ethnicity) were performed assessing the association between endorsement of each automatic intuition and self-reported uptake of COVID-19 vaccines, and between each automatic intuition and general vaccine hesitancy. RESULTS: People who endorsed the authority foundation and those who more strongly endorsed the liberty foundation tended to be more vaccine hesitant. This pattern generalises across people's self-reported uptake of COVID-19 vaccines and people's hesitancy towards vaccines in general. To a lesser extent people who expressed less need for care and a greater need for sanctity also displayed greater hesitancy towards vaccines in general. The results were consistent across the adjusted and non-adjusted analyses. Age and ethnicity significantly contributed to some models but gender did not. CONCLUSION: Four automatic moral intuitions (authority, liberty, care, and sanctity) were significantly associated with vaccine hesitancy. Foundation-aligned messages could be developed to motivate those people who may otherwise refuse vaccines, e.g., messages that strongly promote liberty or that de-emphasize authority voices. This suggestion moves away from mandates and promotes the inclusion of a more diverse range of voices in pro-vaccination campaigns.

Long term impact of prophylactic antibiotic use before incision versus after cord clamping on children born by caesarean section: longitudinal study of UK electronic health records.

OBJECTIVE: To investigate the impact on child health up to age 5 years of a policy to use antibiotic prophylaxis for caesarean section before incision compared with after cord clamping. DESIGN: Observational controlled interrupted time series study. SETTING: UK primary and secondary care. PARTICIPANTS: 515 945 children born in 2006-18 with linked maternal records and registered with general practices contributing to two UK primary care databases (The Health Improvement Network and Clinical Practice Research Datalink), and 7 147 884 children with linked maternal records in the Hospital Episode Statistics database covering England, of which 3 945 351 were linked to hospitals that reported the year of policy change to administer prophylactic antibiotics for caesarean section before incision rather than after cord clamping. INTERVENTION: Fetal exposure to antibiotics shortly before birth (using pre-incision antibiotic policy as proxy) compared with no exposure. MAIN OUTCOME MEASURES: The primary outcomes were incidence rate ratios of asthma and eczema in children born by caesarean section when pre-incision prophylactic antibiotics were recommended compared with those born when antibiotics were administered post-cord clamping, adjusted for temporal changes in the incidence rates in children born vaginally. RESULTS: Prophylactic antibiotics administered before incision for caesarean section compared with after cord clamping were not associated with a significantly higher risk of asthma (incidence rate ratio 0.91, 95% confidence interval 0.78 to 1.05) or eczema (0.98, 0.94 to 1.03), including asthma and eczema resulting in hospital admission (1.05, 0.99 to 1.11 and 0.96, 0.71 to 1.29, respectively), up to age 5 years. CONCLUSIONS: This study found no evidence of an association between pre-incision prophylactic antibiotic use and risk of asthma and eczema in early childhood in children born by caesarean section.

Involving and engaging pregnant women in maternity-related research: reflections on an innovative approach.

BACKGROUND: Meaningful public involvement in maternity research remains challenging, partly due to the transient nature of pregnancy. This paper reflects on the development, implementation and simple evaluation of an innovative and inclusive approach to engaging and involving pregnant and early postnatal women in research. METHODS: Between January and February 2018, a Research Fellow in Maternity Care, a Professor of Evidence Based Maternity Care, and a Patient and Public Involvement Lead convened for a number of meetings to discuss how public involvement and engagement might be improved for pregnancy-related research. A stakeholder group was created, including a local community matron, a community engagement officer at a local children's centre, public contributors, and senior members of the Maternal and Child Health theme of the West Midlands Collaboration for Leadership in Applied Health Research and Care (CLAHRC WM). The team worked together to develop a format for Yoga for Bump sessions: a free 90-min session, offered weekly, which included research involvement/engagement, pregnancy yoga, and a 'question and answer' session with a midwife. RESULTS: A total of 67 women from two local communities in Birmingham attended Yoga for Bump sessions, which ran between May and December of 2018. Evaluation of the sessions suggested benefits to both women and researchers: it created mutually beneficial relationships between contributors and researchers, provided opportunities for women to engage and get involved in research that was directly relevant to them, and provided a convenient and efficient way for researchers to involve and engage pregnant women from diverse backgrounds in their research. Unintended benefits included self-reported improvements in women's health and wellbeing. CONCLUSIONS: Yoga for Bump demonstrates an innovative approach to engaging and involving pregnant and early postnatal women; combining a free exercise class with healthcare advice and opportunities to engage with and be involved in research, and demonstrating mutual benefits for those involved. This model has the potential to be replicated elsewhere to support inclusive public involvement in pregnancy-related research. Further work is needed to design and evaluate similar approaches to involvement/engagement and explore potential funding avenues to enhance sustainability.

Making sure that the public are involved in research is really important. It can sometimes be hard for pregnant women to get involved with research because they are only pregnant for a short amount of time and they are often busy with other things. This means that the research might only feel directly relevant and important to them for a short time. We designed a new way to encourage pregnant women to get involved and engaged in research. We did this by offering a free pregnancy yoga class to women. This class included a 'question and answer' session with a midwife and a discussion with a researcher about some research to do with pregnancy. We ran two classes a week, in two different parts of Birmingham, United Kingdom (UK). The classes took place between May and December 2018 and 67 different women attended the classes. We wanted to see if this was a good way to involve and engage pregnant women in research, so we did a simple evaluation. We used some questionnaires and notes that we had made. We found that the sessions were helpful for both women and researchers. Women enjoyed being involved in the research and told us they had felt healthier and less stressed from the yoga. Researchers found it really useful to be able to talk to women from lots of different backgrounds and experiences. There were some difficult parts of running the sessions, like the costs, and the time needed from us to make sure sessions ran smoothly.

'Snacktivity™' to increase physical activity: Time to try something different?

Evidence demonstrates that participation in regular physical activity (PA) reduces the risk of morbidity and mortality. However, current PA guidelines are focused on weekly accumulation of 150 min of moderate intensity PA as a threshold. Although recent developments of this guidance have discussed the merits of short bouts of physical activity, guidance that sets large behavioural goals for PA has not been successful in supporting the public to become sufficiently physically active and a 'one-size fits all' approach to PA guidelines may not be optimal. A complementary 'whole day' approach to PA promotion (i.e. incorporating PA throughout the day) that could motivate the population to be more physically active, is a concept we have called 'Snacktivity™'. The Snacktivity™ approach promotes small or 'bite' size bouts (e.g. 2-5 min) of PA accumulated throughout the whole day. Snacktivity™ is consistent with the small change approach which suggest that behaviour change and habit formation are best achieved through gradual building of task self-efficacy, celebrating small successes. Snacktivity™ also offers opportunities to "piggyback" on to existing behaviours/habits, using them as prompts for Snacktivity™. Moreover, small behaviour changes are easier to initiate and maintain than larger ones. A plethora of evidence supports the hypothesis that Snacktivity may be a more acceptable and effective way to help the public reach, or exceed current PA guidelines. This paper outlines the evidence to support the Snacktivity™ approach and the mechanisms by which it may increase population levels of physical activity. Future research directions for Snacktivity™ are also outlined.

Information given by websites selling home self-sampling COVID-19 tests: an analysis of accuracy and completeness.

OBJECTIVES: To assess the accuracy and completeness of information provided by websites selling home self-sampling and testing kits for COVID-19. DESIGN: Cross-sectional observational study. SETTING: All websites (n=27) selling direct to user home self-sampling and testing kits for COVID-19 (41 tests) in the UK (39 tests) and USA (two tests) identified by a website search on 23 May 2020. MAIN OUTCOME MEASURES: Thirteen predefined basic information items to communicate to a user, including who should be tested, when and how testing should be done, test accuracy, and interpretation of results. RESULTS: Many websites did not provide the name or manufacturer of the test (32/41; 78%), when to use the test (10/41; 24%), test accuracy (12/41; 29%), and how to interpret results (21/41; 51%). Sensitivity and specificity were the most commonly reported test accuracy measures (either reported for 27/41 [66%] tests): we could only link these figures to manufacturers' documents or publications for four (10%) tests. Predictive values, most relevant to users, were rarely reported (five [12%] tests reported positive predictive values). For molecular virus tests, 9/23 (39%) websites explained that test positives should self-isolate, and 8/23 (35%) explained that test negatives may still have the disease. For antibody tests, 12/18 (67%) websites explained that testing positive does not necessarily infer immunity from future infection. Seven (39%) websites selling antibody tests claimed the test had a CE mark, when they were for a different intended use (venous blood rather than finger-prick samples). CONCLUSIONS: At the point of online purchase of home self-sampling COVID-19 tests, users in the UK are provided with incomplete, and, in some cases, misleading information on test accuracy, intended use, and test interpretation. Best practice guidance for communication about tests to the public should be developed and enforced for online sales of COVID-19 tests.

Global Health in Preconception, Pregnancy and Postpartum Alliance: development of an international consumer and community involvement framework.

BACKGROUND: The goal of the Global Health in Preconception, Pregnancy and Postpartum (HiPPP) Alliance, comprising consumers and leading international multidisciplinary academics and clinicians, is to generate research and translation priorities and build international collaboration around healthy lifestyle and obesity prevention among women across the reproductive years. In doing so, we actively seek to involve consumers in research, implementation and translation initiatives. There are limited frameworks specifically designed to involve women across the key obesity prevention windows before (preconception), during and after pregnancy (postpartum). The aim of this paper is to outline our strategy for the development of the HiPPP Consumer and Community (CCI) Framework, with consumers as central to co-designed, co-implemented and co-disseminated research and translation. METHOD: The development of the framework involved three phases: In Phase 1, 21 Global HiPPP Alliance members participated in a CCI workshop to propose and discuss values and approaches for framework development; Phase 2 comprised a search of peer-reviewed and grey literature for existing CCI frameworks and resources; and Phase 3 entailed collaboration with consumers (i.e., members of the public with lived experience of weight/lifestyle issues in preconception, pregnancy and postpartum) and international CCI experts to workshop and refine the HiPPP CCI Framework (guided by Phases 1 and 2). RESULTS: The HiPPP CCI Framework's values and approaches identified in Phases 1-2 and further refined in Phase 3 were summarized under the following five key principles: 1. Inclusive, 2. Flexible, 3. Transparent, 4. Equitable, and 5. Adaptable. The HiPPP Framework describes values and approaches for involving consumers in research initiatives from design to translation that focus on improving healthy lifestyles and preventing obesity specifically before, during and after pregnancy; importantly it takes into consideration common barriers to partnering in obesity research during perinatal life stages, such as limited availability associated with family caregiving responsibilities. CONCLUSION: The HiPPP CCI Framework aims to describe approaches for implementing meaningful CCI initiatives with women in preconception, pregnancy and postpartum periods. Evaluation of the framework is now needed to understand how effective it is in facilitating meaningful involvement for consumers, researchers and clinicians, and its impact on research to improve healthy lifestyle outcomes.

Publication and related biases in health services research: a systematic review of empirical evidence.

BACKGROUND: Publication and related biases (including publication bias, time-lag bias, outcome reporting bias and p-hacking) have been well documented in clinical research, but relatively little is known about their presence and extent in health services research (HSR). This paper aims to systematically review evidence concerning publication and related bias in quantitative HSR. METHODS: Databases including MEDLINE, EMBASE, HMIC, CINAHL, Web of Science, Health Systems Evidence, Cochrane EPOC Review Group and several websites were searched to July 2018. Information was obtained from: (1) Methodological studies that set out to investigate publication and related biases in HSR; (2) Systematic reviews of HSR topics which examined such biases as part of the review process. Relevant information was extracted from included studies by one reviewer and checked by another. Studies were appraised according to commonly accepted scientific principles due to lack of suitable checklists. Data were synthesised narratively. RESULTS: After screening 6155 citations, four methodological studies investigating publication bias in HSR and 184 systematic reviews of HSR topics (including three comparing published with unpublished evidence) were examined. Evidence suggestive of publication bias was reported in some of the methodological studies, but evidence presented was very weak, limited in both quality and scope. Reliable data on outcome reporting bias and p-hacking were scant. HSR systematic reviews in which published literature was compared with unpublished evidence found significant differences in the estimated intervention effects or association in some but not all cases. CONCLUSIONS: Methodological research on publication and related biases in HSR is sparse. Evidence from available literature suggests that such biases may exist in HSR but their scale and impact are difficult to estimate for various reasons discussed in this paper. SYSTEMATIC REVIEW REGISTRATION: PROSPERO 2016 CRD42016052333.

Stakeholder views on publication bias in health services research.

OBJECTIVES: While the presence of publication bias in clinical research is well documented, little is known about its role in the reporting of health services research. This paper explores stakeholder perceptions and experiences with regard to the role of publication and related biases in quantitative research relating to the quality, accessibility and organization of health services. METHODS: We present findings from semi-structured interviews with those responsible for the funding, publishing and/or conduct of quantitative health services research, primarily in the UK. Additional data collection includes interviews with health care decision makers as 'end users' of health services research, and a focus group with patient and service user representatives. The final sample comprised 24 interviews and eight focus group participants. RESULTS: Many study participants felt unable to say with any degree of certainty whether publication bias represents a significant problem in quantitative health services research. Participants drew broad contrasts between externally funded and peer reviewed research on the one hand, and end user funded quality improvement projects on the other, with the latter perceived as more vulnerable to selective publication and author over-claiming. Multiple study objectives, and a general acceptance of 'mess and noise' in the data and its interpretation was seen to reduce the importance attached to replicable estimates of effect sizes in health services research. The relative absence of external scrutiny, either from manufacturers of interventions or health system decision makers, added to this general sense of 'low stakes' of health services research. As a result, while many participants advocated study pre-registration and using protocols to pre-identify outcomes, others saw this as an unwarranted imposition. CONCLUSIONS: This study finds that incentives towards publication and related bias are likely to be present, but not to the same degree as in clinical research. In health services research, these were seen as being offset by other forms of 'novelty' bias in the reporting and publishing of research findings.

Assessment of publication bias and outcome reporting bias in systematic reviews of health services and delivery research: A meta-epidemiological study.

Strategies to identify and mitigate publication bias and outcome reporting bias are frequently adopted in systematic reviews of clinical interventions but it is not clear how often these are applied in systematic reviews relating to quantitative health services and delivery research (HSDR). We examined whether these biases are mentioned and/or otherwise assessed in HSDR systematic reviews, and evaluated associating factors to inform future practice. We randomly selected 200 quantitative HSDR systematic reviews published in the English language from 2007-2017 from the Health Systems Evidence database (www.healthsystemsevidence.org). We extracted data on factors that may influence whether or not authors mention and/or assess publication bias or outcome reporting bias. We found that 43% (n = 85) of the reviews mentioned publication bias and 10% (n = 19) formally assessed it. Outcome reporting bias was mentioned and assessed in 17% (n = 34) of all the systematic reviews. Insufficient number of studies, heterogeneity and lack of pre-registered protocols were the most commonly reported impediments to assessing the biases. In multivariable logistic regression models, both mentioning and formal assessment of publication bias were associated with: inclusion of a meta-analysis; being a review of intervention rather than association studies; higher journal impact factor, and; reporting the use of systematic review guidelines. Assessment of outcome reporting bias was associated with: being an intervention review; authors reporting the use of Grading of Recommendations, Assessment, Development and Evaluations (GRADE), and; inclusion of only controlled trials. Publication bias and outcome reporting bias are infrequently assessed in HSDR systematic reviews. This may reflect the inherent heterogeneity of HSDR evidence and different methodological approaches to synthesising the evidence, lack of awareness of such biases, limits of current tools and lack of pre-registered study protocols for assessing such biases. Strategies to help raise awareness of the biases, and methods to minimise their occurrence and mitigate their impacts on HSDR systematic reviews, are needed.

Long-term impact of giving antibiotics before skin incision versus after cord clamping on children born by caesarean section: protocol for a longitudinal study based on UK electronic health records.

INTRODUCTION: In the UK, about a quarter of women give birth by caesarean section (CS) and are offered prophylactic broad-spectrum antibiotics to reduce the risk of maternal postpartum infection. In 2011, national guidance was changed from recommending antibiotics after the umbilical cord was cut to giving antibiotics prior to skin incision based on evidence that earlier administration reduces maternal infectious morbidity. Although antibiotics cross the placenta, there are no known short-term harms to the baby. This study aims to address the research gap on longer term impact of these antibiotics on child health. METHODS AND ANALYSIS: A controlled interrupted time series study will use anonymised mother-baby linked routine electronic health records for children born during 2006-2018 recorded in UK primary care (The Health Improvement Network, THIN and Clinical Practice Research Datalink, CPRD) and secondary care (Hospital Episode Statistics, HES) databases. The primary outcomes of interest are asthma and eczema, two common allergy-related diseases in childhood. In-utero exposure to antibiotics immediately prior to CS will be compared with no exposure when given after cord clamping. The risk of outcomes in children delivered by CS will also be compared with a control cohort delivered vaginally to account for time effects. We will use all available data from THIN, CPRD and HES with estimated power of 80% and 90% to detect relative increase in risk of asthma of 16% and 18%, respectively at the 5% significance level. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the University of Birmingham Ethical Review Committee with scientific approvals obtained from the independent scientific advisory committees from the Medicines and Healthcare products Regulatory Agency for CPRD and the data provider, IQVIA for THIN. The results will be published in peer-reviewed journals, presented at national and international conferences and disseminated to stakeholders.