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1.  Ethnic variations in asthma hospital admission, readmission and death: a retrospective, national cohort study of 4.62 million people in Scotland 
BMC Medicine  2016;14:3.
Our previous meta-analysis found that South Asians and Blacks in the UK were at a substantially increased risk of hospital admission from asthma. These estimates were, however, derived from pooling data from a limited number of now dated studies, confined to only three very broad ethnic groups (i.e. Whites, South Asians and Blacks) and failed to take account of possible sex-related differences in outcomes within these ethnic groups. We undertook the first study investigating ethnic variations in asthma outcomes across an entire population.
This retrospective 9-year cohort study linked Scotland’s hospitalisation/death records on asthma to the 2001 census (providing ethnic group). We calculated age, country of birth and Scottish Index of Multiple Deprivation adjusted incident rate ratios (IRRs) for hospitalisation or death by sex for the period May 2001–2010. We calculated hazard ratios (HRs) for asthma readmission and subsequent asthma death.
We were able to link data on 4.62 million people (91.8 % of the Scottish population), yielding over 38 million patient-years of data, 1,845 asthma deaths, 113,795 first asthma admissions, and 107,710 readmissions (40,075 of which were for asthma). There were substantial ethnic variations in the rate of hospitalisation/death in both males and females. When compared to the reference Scottish White population, the highest age-adjusted rates were in Pakistani males (IRR = 1.59; 95 % CI, 1.30–1.94) and females (IRR = 1.50; 95 % CI, 1.06–2.11) and Indian males (IRR = 1.34; 95 % CI, 1.16–1.54), and the lowest were seen in Chinese males (IRR = 0.62; 95 % CI, 0.41–0.94) and females (IRR = 0.49; 95 % CI, 0.39–0.61).
There are very substantial ethnic variations in hospital admission/deaths from asthma in Scotland, with Pakistanis having the worst and Chinese having the best outcomes. Cultural factors, including self-management and health seeking behaviours, and variations in the quality of primary care provision are the most likely explanations for these differences and these now need to be formally investigated.
PMCID: PMC4710027  PMID: 26755184
Asthma; Death; Epidemiology; Ethnic variations; Hospital admission
2.  Qualitative study of telemonitoring of blood glucose and blood pressure in type 2 diabetes 
BMJ Open  2015;5(12):e008896.
To explore the experiences of patients and professionals taking part in a randomised controlled trial (RCT) of blood glucose, blood pressure (BP) and weight telemonitoring in type 2 diabetes supported by primary care, and identify factors facilitating or hindering the effectiveness of the intervention and those likely to influence its potential translation to routine practice.
Qualitative study adopting an interpretive descriptive approach.
23 patients, 6 nurses and 4 doctors who were participating in a RCT of blood glucose and BP telemonitoring. A maximum variation sample of patients from within the trial based on age, sex and deprivation status of the practice was sought.
12 primary care practices in Scotland and England.
Data were collected via recorded semistructured interviews. Analysis was inductive with themes presented within an overarching thematic framework. Multiple strategies were employed to ensure that the analysis was credible and trustworthy.
Telemonitoring of blood glucose, BP and weight by people with type 2 diabetes was feasible. The data generated by telemonitoring supported self-care decisions and medical treatment decisions. Motivation to self-manage diet was increased by telemonitoring of blood glucose, and the ‘benign policing’ aspect of telemonitoring was considered by patients to be important. The convenience of home monitoring was very acceptable to patients although professionals had some concerns about telemonitoring increasing workload and costs.
Telemonitoring of blood glucose, BP and weight in primary care is a promising way of improving diabetes management which would be highly acceptable to the type of patients who volunteered for this study.
Trial registration number
ISRCTN71674628; Pre-results.
PMCID: PMC4691739  PMID: 26700275
3.  Global and regional estimates of COPD prevalence: Systematic review and meta–analysis 
Journal of Global Health  null;5(2):020415.
The burden of chronic obstructive pulmonary disease (COPD) across many world regions is high. We aim to estimate COPD prevalence and number of disease cases for the years 1990 and 2010 across world regions based on the best available evidence in publicly accessible scientific databases.
We conducted a systematic search of Medline, EMBASE and Global Health for original, population–based studies providing spirometry–based prevalence rates of COPD across the world from January 1990 to December 2014. Random effects meta–analysis was conducted on extracted crude prevalence rates of COPD, with overall summaries of the meta–estimates (and confidence intervals) reported separately for World Health Organization (WHO) regions, the World Bank's income categories and settings (urban and rural). We developed a meta–regression epidemiological model that we used to estimate the prevalence of COPD in people aged 30 years or more.
Our search returned 37 472 publications. A total of 123 studies based on a spirometry–defined prevalence were retained for the review. From the meta–regression epidemiological model, we estimated about 227.3 million COPD cases in the year 1990 among people aged 30 years or more, corresponding to a global prevalence of 10.7% (95% confidence interval (CI) 7.3%–14.0%) in this age group. The number of COPD cases increased to 384 million in 2010, with a global prevalence of 11.7% (8.4%–15.0%). This increase of 68.9% was mainly driven by global demographic changes. Across WHO regions, the highest prevalence was estimated in the Americas (13.3% in 1990 and 15.2% in 2010), and the lowest in South East Asia (7.9% in 1990 and 9.7% in 2010). The percentage increase in COPD cases between 1990 and 2010 was the highest in the Eastern Mediterranean region (118.7%), followed by the African region (102.1%), while the European region recorded the lowest increase (22.5%). In 1990, we estimated about 120.9 million COPD cases among urban dwellers (prevalence of 13.2%) and 106.3 million cases among rural dwellers (prevalence of 8.8%). In 2010, there were more than 230 million COPD cases among urban dwellers (prevalence of 13.6%) and 153.7 million among rural dwellers (prevalence of 9.7%). The overall prevalence in men aged 30 years or more was 14.3% (95% CI 13.3%–15.3%) compared to 7.6% (95% CI 7.0%–8.2%) in women.
Our findings suggest a high and growing prevalence of COPD, both globally and regionally. There is a paucity of studies in Africa, South East Asia and the Eastern Mediterranean region. There is a need for governments, policy makers and international organizations to consider strengthening collaborations to address COPD globally.
PMCID: PMC4693508  PMID: 26755942
4.  Experiences of Self-Management Support Following a Stroke: A Meta-Review of Qualitative Systematic Reviews 
PLoS ONE  2015;10(12):e0141803.
Supporting self-management in stroke patients improves psychological and functional outcomes but evidence on how to achieve this is sparse. We aimed to synthesise evidence from systematic reviews of qualitative studies in an overarching meta-review to inform the delivery and development of self-management support interventions.
We systematically searched eight electronic databases including MEDLINE, EMBASE and CINAHL for qualitative systematic reviews (published January 1993 to June 2012). We included studies exploring patients’, carers’ or health care professionals’ experiences relevant to self-management support following a stroke, including studies describing the lived experience of surviving a stroke. We meta-synthesised the included review findings using a meta-ethnographic framework.
Seven reviews, reporting 130 unique studies, were included. Themes emerging from the reviews were pertinent, consistent and showed data saturation; though explicit mention of self-management support was rare. Our meta-review highlighted the devastating impact of stroke on patients’ self-image; the varying needs for self-management support across the trajectory of recovery; the need for psychological and emotional support throughout recovery particularly when physical recovery plateaus; the considerable information needs of patients and carers which also vary across the trajectory of recovery; the importance of good patient-professional communication; the potential benefits of goal-setting and action-planning; and the need for social support which might be met by groups for stroke survivors.
The observed data saturation suggests that, currently, no further qualitative research simply describing the lived experience of stroke is needed; we propose that it would be more useful to focus on qualitative research informing self-management support interventions and their implementation. Our findings demonstrate both the on-going importance of self-management support and the evolving priorities throughout the stages of recovery following a stroke. The challenge now is to ensure these findings inform routine practice and the development of interventions to support self-management amongst stroke survivors.
PMCID: PMC4682853  PMID: 26657458
5.  Understanding faith considerations when caring for bereaved Muslims 
PMCID: PMC3536508  PMID: 23288085
6.  A cross-sectional mixed methods study protocol to generate learning from patient safety incidents reported from general practice 
BMJ Open  2015;5(12):e009079.
Incident reports contain descriptions of errors and harms that occurred during clinical care delivery. Few observational studies have characterised incidents from general practice, and none of these have been from the England and Wales National Reporting and Learning System. This study aims to describe incidents reported from a general practice care setting.
Methods and analysis
A general practice patient safety incident classification will be developed to characterise patient safety incidents. A weighted-random sample of 12 500 incidents describing no harm, low harm and moderate harm of patients, and all incidents describing severe harm and death of patients will be classified. Insights from exploratory descriptive statistics and thematic analysis will be combined to identify priority areas for future interventions.
Ethics and dissemination
The need for ethical approval was waivered by the Aneurin Bevan University Health Board research risk review committee given the anonymised nature of data (ABHB R&D Ref number: SA/410/13). The authors will submit the results of the study to relevant journals and undertake national and international oral presentations to researchers, clinicians and policymakers.
PMCID: PMC4680001  PMID: 26628526
7.  Harms from discharge to primary care: mixed methods analysis of incident reports 
The British Journal of General Practice  2015;65(641):e829-e837.
Discharge from hospital presents significant risks to patient safety, with up to one in five patients experiencing adverse events within 3 weeks of leaving hospital.
To describe the frequency and types of patient safety incidents associated with discharge from secondary to primary care, and commonly described contributory factors to identify recommendations for practice.
Design and setting
A mixed methods analysis of 598 patient safety incident reports in England and Wales related to ‘Discharge’ from the National Reporting and Learning System.
Detailed data coding (with 20% double-coding), data summaries generated using descriptive statistical analysis, and thematic analysis of special-case sample of reports. Incident type, contributory factors, type, and level of harm were described, informing recommendations for future practice.
A total of 598 eligible reports were analysed. The four main themes were: errors in discharge communication (n = 151; 54% causing harm); errors in referrals to community care (n = 136; 73% causing harm); errors in medication (n = 97; 87% causing harm); and lack of provision of care adjuncts such as dressings (n = 62; 94% causing harm). Common contributory factors were staff factors (not following referral protocols); and organisational factors (lack of clear guidelines or inefficient processes). Improvement opportunities include developing and testing electronic discharge methods with agreed minimum information requirements and unified referrals systems to community care providers; and promoting a safety culture with ‘safe discharge’ checklists, discharge coordinators, and family involvement.
Significant harm was evident due to deficits in the discharge process. Interventions in this area need to be evaluated and learning shared widely.
PMCID: PMC4655737  PMID: 26622036
adverse events; discharge; harm; patient safety; primary care; safety incident reports
8.  Qualitative analysis of vendor discussions on the procurement of Computerised Physician Order Entry and Clinical Decision Support systems in hospitals 
BMJ Open  2015;5(10):e008313.
We studied vendor perspectives about potentially transferable lessons for implementing organisations and national strategies surrounding the procurement of Computerised Physician Order Entry (CPOE)/Clinical Decision Support (CDS) systems in English hospitals.
Data were collected from digitally audio-recorded discussions from a series of CPOE/CDS vendor round-table discussions held in September 2014 in the UK.
Nine participants, representing 6 key vendors operating in the UK, attended. The discussions were transcribed verbatim and thematically analysed.
Vendors reported a range of challenges surrounding the procurement and contracting processes of CPOE/CDS systems, including hospitals’ inability to adequately assess their own needs and then select a suitable product, rushed procurement and implementation processes that resulted in difficulties in meaningfully engaging with vendors, as well as challenges relating to contracting leading to ambiguities in implementation roles. Consequently, relationships between system vendors and hospitals were often strained, the vendors attributing this to a lack of hospital management's appreciation of the complexities associated with implementation efforts. Future anticipated challenges included issues surrounding the standardisation of data to enable their aggregation across systems for effective secondary uses, and implementation of data exchange with providers outside the hospital.
Our results indicate that there are significant issues surrounding capacity to procure and optimise CPOE/CDS systems among UK hospitals. There is an urgent need to encourage more synergistic and collaborative working between providers and vendors and for a more centralised support for National Health Service hospitals, which draws on a wider body of experience, including a formalised procurement framework with value-based product specifications.
PMCID: PMC4636661  PMID: 26503385
9.  The impact of electronic prescribing systems on pharmacists’ time and workflow: protocol for a time-and-motion study in English NHS hospitals 
BMJ Open  2015;5(10):e008785.
Electronic prescribing (ePrescribing) systems are rapidly being introduced into National Health Systems (NHS) hospitals in England following their widespread earlier adoption into primary care settings. Such systems require substantial changes in the way pharmacists organise their work and perform their roles. There is however as yet limited evidence on the extent to which these changes may support or compromise efficient and safe working practices by pharmacists. Identifying and quantifying these changes, and their effects, is central to informing system and work practice design, as well as informing training and implementation processes. This protocol describes a study to measure the impact of ePrescribing systems on pharmacists’ time and workflow.
Methods and analysis
A direct observational controlled pre–post implementation time-and-motion study will be conducted in six wards at one NHS Trust over two observational periods. Pharmacists will be shadowed and details of all work tasks performed will be collected and time-stamped. Task distribution, frequency and duration will be measured and changes in these measures preimplementation and postimplementation, and between control and intervention wards will be measured. Interviews with pharmacists will investigate their perceptions of the impact of the ePrescribing systems on their work and will be conducted in both periods. The extent to which pharmacists’ expectations of the impact of the ePrescribing systems on their work with postimplementation reports will be qualitatively explored, as will any differences between perceptions and results from the time-and-motion analysis.
Ethics and dissemination
Institutional research ethics approval has been obtained from The University of Edinburgh. Local approval from the participating NHS Trust and informed consent from participating pharmacists have been obtained, while also complying with local governance requirements. The results of the study will be presented at conferences, published in peer-reviewed journals, and shared with members of our Patient and Public Involvement Group, to facilitate wider dissemination.
PMCID: PMC4636672  PMID: 26503390
Time-and-motion study; electronic Prescribing; pharmacists
10.  The ‘vicious cycle’ of personalised asthma action plan implementation in primary care: a qualitative study of patients and health professionals’ views 
BMC Family Practice  2015;16:145.
Personal asthma action plans (PAAPs) have been guideline recommended for years, but consistently under-issued by health professionals and under-utilised by patients. Previous studies have investigated sub-optimal PAAP implementation but more insight is needed into barriers to their use from the perspective of professionals, patients and primary care teams.
A maximum variation sample of professional and patient participants were recruited from five demographically diverse general practices and another group of primary care professionals in one Scottish region. Interviews were digitally recorded and data thematically analysed using NVivo.
Twenty-nine semi-structured interviews were conducted (11 adults with asthma, seven general practitioners, ten practice nurses, one hospital respiratory nurse). Three over-arching themes emerged: 1) patients generally do not value PAAPs, 2) professionals do not fully value PAAPs and, 3) multiple barriers reduce the value of PAAPs in primary care. Six patients had a PAAP but these were outdated, not reflecting their needs and not used. Patients reported not wanting or needing PAAPs, yet identified circumstances when these could be useful. Fifteen professionals had selectively issued PAAPs with eight having reviewed one. Many professionals did not value PAAPs as they did not see patients using these and lacked awareness of times when patients could have benefited from one. Multi-level compounding barriers emerged. Individual barriers included poor patient awareness and professionals not reinforcing PAAP use. Organisational barriers included professionals having difficulty accessing PAAP templates and fragmented processes including patients not being asked to bring PAAPs to their asthma appointments.
Primary care PAAP implementation is in a vicious cycle. Professionals infrequently review/update PAAPs with patients; patients with out-dated PAAPs do not value or use these; professionals observing patients’ lack of interest in PAAPs do not discuss these. Patients observing this do not refer to their plans and perceive them to be of little value in asthma self-management. Twenty-five years after PAAPs were first recommended, primary care practices are still not ready to support their implementation. Breaking this vicious cycle to create a healthcare context more conducive to PAAP implementation requires a whole systems approach with multi-faceted interventions addressing patient, professional and organisational barriers.
Electronic supplementary material
The online version of this article (doi:10.1186/s12875-015-0352-4) contains supplementary material, which is available to authorized users.
PMCID: PMC4618358  PMID: 26487557
Barriers; Implementation; Personalised asthma action plans; Primary care; Qualitative; Self-management plans
11.  Evaluation of medium-term consequences of implementing commercial computerized physician order entry and clinical decision support prescribing systems in two ‘early adopter’ hospitals 
To understand the medium-term consequences of implementing commercially procured computerized physician order entry (CPOE) and clinical decision support (CDS) systems in ‘early adopter’ hospitals.
Materials and methods
In-depth, qualitative case study in two hospitals using a CPOE or a CDS system for at least 2 years. Both hospitals had implemented commercially available systems. Hospital A had implemented a CPOE system (with basic decision support), whereas hospital B invested additional resources in a CDS system that facilitated order entry but which was integrated with electronic health records and offered more advanced CDS. We used a combination of documentary analysis of the implementation plans, audiorecorded semistructured interviews with system users, and observations of strategic meetings and systems usage.
We collected 11 documents, conducted 43 interviews, and conducted a total of 21.5 h of observations. We identified three major themes: (1) impacts on individual users, including greater legibility of prescriptions, but also some accounts of increased workloads; (2) the introduction of perceived new safety risks related to accessibility and usability of hardware and software, with users expressing concerns that some problems such as duplicate prescribing were more likely to occur; and (3) realizing organizational benefits through secondary uses of data.
We identified little difference in the medium-term consequences of a CPOE and a CDS system. It is important that future studies investigate the medium- and longer-term consequences of CPOE and CDS systems in a wider range of hospitals.
PMCID: PMC4173168  PMID: 24431334
Cpoe; CDS; Implementation; Adoption; Eprescribing
12.  A qualitative study identifying the cost categories associated with electronic health record implementation in the UK 
We conducted a prospective evaluation of different forms of electronic health record (EHR) systems to better understand the costs incurred during implementation and the factors that can influence these costs.
We selected a range of diverse organizations across three different geographical areas in England that were at different stages of implementing three centrally procured applications, that is, iSOFT's Lorenzo Regional Care, Cerner's Millennium, and CSE's RiO. 41 semi-structured interviews were conducted with hospital staff, members of the implementation team, and those involved in the implementation at a national level.
Four main overarching cost categories were identified: infrastructure (eg, hardware and software), personnel (eg, training team), estates/facilities (eg, space), and other (eg, training materials). Many factors were felt to impact on these costs, with different hospitals choosing varying amounts and types of infrastructure, diverse training approaches for staff, and different software applications to integrate with the new system.
Improving the quality and safety of patient care through EHR adoption is a priority area for UK and US governments and policy makers worldwide. With cost considered one of the most significant barriers, it is important for hospitals and governments to be clear from the outset of the major cost categories involved and the factors that may impact on these costs. Failure to adequately train staff or to follow key steps in implementation has preceded many of the failures in this domain, which can create new safety hazards.
PMCID: PMC4173176  PMID: 24523391
13.  Cardiovascular and neuropsychiatric risks of varenicline: a retrospective cohort study 
The Lancet. Respiratory Medicine  2015;3(10):761-768.
Varenicline is an effective pharmacotherapy to aid smoking cessation. However, its use is limited by continuing concerns about possible associated risks of serious adverse cardiovascular and neuropsychiatric events. The aim of this study was to investigate whether use of varenicline is associated with such events.
In this retrospective cohort study, we used data from patients included in the validated QResearch database, which holds data from 753 National Health Service general practices across England. We identified patients aged 18–100 years (registered for longer than 12 months before data extraction) who received a prescription of nicotine replacement treatment (NRT; reference group), bupropion, or varenicline. We excluded patients if they had used one of the drugs during the 12 months before the start date of the study, had received a prescription of a combination of these drugs during the follow-up period, or were temporary residents. We followed patients up for 6 months to compare incident cardiovascular (ischaemic heart disease, cerebral infarction, heart failure, peripheral vascular disease, and cardiac arrhythmia) and neuropsychiatric (depression and self-harm) events using Cox proportional hazards models, adjusted for potential confounders (primary outcomes).
We identified 164 766 patients who received a prescription (106 759 for nicotine replacement treatment; 6557 for bupropion; 51 450 for varenicline) between Jan 1, 2007, and June 30, 2012. Neither bupropion nor varenicline showed an increased risk of any cardiovascular or neuropsychiatric event compared with NRT (all hazard ratios [HRs] less than 1. Varenicline was associated with a significantly reduced risk of ischaemic heart disease (HR 0·80 [95%CI 0·72–0·87]), cerebral infarction (0·62 [0·52–0·73]), heart failure (0·61 [0·45–0·83]), arrhythmia (0·73 [0·60–0·88]), depression (0·66 [0·63–0·69]), and self-harm (0·56 [0·46–0·68]).
Varenicline does not seem to be associated with an increased risk of documented cardiovascular events, depression, or self-harm when compared with NRT. Adverse events that do not come to attention of general practitioners cannot be excluded. These findings suggest an opportunity for physicians to prescribe varenicline more broadly, even for patients with comorbidities, thereby helping more smokers to quit successfully than do at present.
Egton Medical Information Systems, University of Nottingham, Ministry of Innovation, Science and Research of the German Federal State of North Rhine-Westphalia, Cancer Research UK, Medical Research Council, Commonwealth Fund.
PMCID: PMC4593936  PMID: 26355008
14.  Tobacco control policies and perinatal and child health: a systematic review and meta-analysis protocol 
BMJ Open  2015;5(9):e008398.
Children experience considerable morbidity and mortality due to tobacco smoke exposure. Tobacco control policies may benefit child health by reducing this exposure. We aim to comprehensively assess the effects of the range of tobacco control policies advocated by the WHO on perinatal and child health.
Methods and analysis
We will systematically search 19 electronic literature databases (from inception) for published studies, and the WHO International Clinical Trials Registry Platform for unpublished studies. Additional work will be identified via handsearching references and citations, and through consulting an international panel of experts. No language restrictions will apply. Following Cochrane Effective Practice and Organisation of Care (EPOC) guidelines, randomised and clinical controlled trials, controlled before-and-after studies, and interrupted time series designs, are eligible. Studies of interest will assess the impact of any of the WHO-advocated tobacco control policies contained in the MPOWER acronym (except ‘Monitoring tobacco use’) on at least one outcome of interest among children aged 0–12 years. The primary outcomes are: perinatal mortality, preterm birth, asthma exacerbations requiring hospital attendance and respiratory infections requiring hospital attendance. Data will be extracted using customised forms and authors will be contacted to obtain missing information. Risk of bias will be assessed using EPOC criteria. Findings will be reported in narrative and tabular form. Between-study heterogeneity will be assessed clinically and statistically using I2. If appropriate and possible, random-effects meta-analysis will be conducted for each unique combination of intervention and outcome. Subgroup analyses will be performed to assess the influence of the comprehensiveness of each policy, and to explore the impact of each policy according to socioeconomic status.
Ethics and dissemination
No ethical assessment is necessary as we will summarise existing studies. We will publish our findings in a peer-reviewed scientific journal.
Trial registration number
PROSPERO; CRD42015023448.
PMCID: PMC4593151  PMID: 26399572
15.  Hormonal contraceptives and asthma in women of reproductive age: analysis of data from serial national Scottish Health Surveys 
Sex steroid hormones may explain known gender-related variations in asthma prevalence and clinical manifestation. We investigated the relationship between use of hormonal contraceptives and asthma in women, and assessed evidence of biological interaction between use of hormonal contraceptives and body mass index in this relationship.
Population-based analysis using data from serial (i.e. 2003, 2008 and 2010) Scottish Health Surveys.
Random samples of the Scottish general population.
A total of 3257 non-pregnant, 16–45-year-old women.
Current use of hormonal contraceptives.
Main outcome measures
Self-reported current physician-diagnosed asthma, current wheezing symptoms, wheezing attacks and treatment for asthma or wheeze.
Women comprising 30.9% (95% confidence interval 29.3–32.5) were currently using any hormonal contraceptive and current physician-diagnosed asthma was present in 6.5% (95% confidence interval 5.7–7.4). Use of any hormonal contraceptive was associated with reduced risk of current physician-diagnosed asthma (odds ratio 0.68; 95% confidence interval 0.47–0.98) and receiving ≥3 asthma care episodes (odds ratio 0.45; 95% confidence interval 0.25–0.82), but the evidence was equivocal for wheezing attacks. Use of hormonal contraceptives among overweight or obese women was non-statistically significantly associated with asthma, but there was 42–135% increased risk in overweight and obese non-contraceptive using women.
Use of hormonal contraceptives may reduce asthma exacerbations and number of care episodes. Overweight and obese non-contraceptive-using women may be at increased risk of asthma. Prospective studies are now needed to confirm these findings. Both oestrogen and progesterone may stimulate smooth airway muscle function and inhibit the activities of TH2 responses. Future studies should investigate these underlying mechanisms.
PMCID: PMC4582260  PMID: 26152676
Asthma; hormonal contraceptives; oestrogen; progesterone; wheeze; women
16.  Muslim communities learning about second-hand smoke: a pilot cluster randomised controlled trial and cost-effectiveness analysis 
In the United Kingdom, men of Bangladeshi and Pakistani origin have higher smoking rates than the general population. This makes non-smokers in their households more vulnerable to second-hand smoke (SHS) exposure than the general population.
The aim of this study was to investigate the feasibility of implementing and pilot testing the effectiveness and cost-effectiveness of a ‘Smoke-free Homes’ (SFH) intervention in Islamic religious settings to encourage families of Bangladeshi and Pakistani origin to apply smoking restrictions in their homes.
We allocated Islamic religious settings (clusters) to either receive SFH—an educational intervention—or to a control arm. Within each cluster, we recruited households with at least one smoker and one non-smoker. SHS exposure among non-smokers was measured using salivary cotinine.
Seven (50%) clusters were randomised to each trial arm. A total of 468 households were assessed for eligibility and 62% (n=289) were eligible, of which 74% (n=213) agreed to participate in the trial. Six of the seven intervention clusters delivered the intervention, and all clusters were retained throughout the trial. In all, 81% (n=172) of households provided data at follow-up. No evidence of a difference in log cotinine level was observed (adjusted mean difference −0.02, 95% confidence interval (CI) −1.28–1.23, P=0.97) between the two trial arms. The direct mean cost of delivering the intervention was £18.18 per household (range £3.55–42.20).
It was possible to recruit, randomise and retain Islamic religious settings and participant households. However, some of the original assumptions, in particular our ability to collect primary outcome data, need to be revisited before a definitive trial.
PMCID: PMC4551097  PMID: 26313312
17.  Children Learning About Secondhand Smoke (CLASS II): protocol of a pilot cluster randomised controlled trial 
BMJ Open  2015;5(8):e008749.
Exposure to secondhand smoke (SHS) increases children’s risk of acquiring chest and ear infections, tuberculosis, meningitis and asthma. Smoking bans in public places (where implemented) have significantly reduced adults’ exposure to SHS. However, for children, homes remain the most likely place for them to be exposed to SHS. Additional measures are therefore required to protect children from SHS. In a feasibility study in Dhaka, Bangladesh, we have shown that a school-based smoke-free intervention (SFI) was successful in encouraging children to negotiate and implement smoking restrictions in homes. We will now conduct a pilot trial to inform plans to undertake a cluster randomised controlled trial (RCT) investigating the effectiveness and cost-effectiveness of SFI in reducing children’s exposure to SHS.
Methods and analysis
We plan to recruit 12 primary schools in Dhaka, Bangladesh. From these schools, we will recruit approximately 360 schoolchildren in year 5 (10–12 years old), that is, 30 per school. SFI consists of six interactive educational activities aimed at increasing pupils’ knowledge about SHS and related harms, motivating them to act, providing skills to negotiate with adults to persuade them not to smoke inside homes and helping families to ‘sign-up’ to a voluntary contract to make their homes smoke-free. Children in the control arm will receive the usual education. We will estimate: recruitment and attrition rates, acceptability, fidelity to SFI, effect size, intracluster correlation coefficient, cost of intervention and adverse events. Our primary outcome will consist of SHS exposure in children measured by salivary cotinine. Secondary outcomes will include respiratory symptoms, lung function tests, healthcare contacts, school attendance, smoking uptake, quality of life and academic performance.
Ethics and dissemination
The trial has received ethics approval from the Research Governance Committee at the University of York. Findings will help us plan for the definitive trial.
Trial registration number
PMCID: PMC4550726  PMID: 26307620
second-hand smoking; passive smoking; children; school; tobacco
18.  Effects of Air Pollution and the Introduction of the London Low Emission Zone on the Prevalence of Respiratory and Allergic Symptoms in Schoolchildren in East London: A Sequential Cross-Sectional Study 
PLoS ONE  2015;10(8):e0109121.
The adverse effects of traffic-related air pollution on children’s respiratory health have been widely reported, but few studies have evaluated the impact of traffic-control policies designed to reduce urban air pollution. We assessed associations between traffic-related air pollutants and respiratory/allergic symptoms amongst 8–9 year-old schoolchildren living within the London Low Emission Zone (LEZ). Information on respiratory/allergic symptoms was obtained using a parent-completed questionnaire and linked to modelled annual air pollutant concentrations based on the residential address of each child, using a multivariable mixed effects logistic regression analysis. Exposure to traffic-related air pollutants was associated with current rhinitis: NOx (OR 1.01, 95% CI 1.00–1.02), NO2 (1.03, 1.00–1.06), PM10 (1.16, 1.04–1.28) and PM2.5 (1.38, 1.08–1.78), all per μg/m3 of pollutant, but not with other respiratory/allergic symptoms. The LEZ did not reduce ambient air pollution levels, or affect the prevalence of respiratory/allergic symptoms over the period studied. These data confirm the previous association between traffic-related air pollutant exposures and symptoms of current rhinitis. Importantly, the London LEZ has not significantly improved air quality within the city, or the respiratory health of the resident population in its first three years of operation. This highlights the need for more robust measures to reduce traffic emissions.
PMCID: PMC4546643  PMID: 26295579
19.  Global burden of disease due to smokeless tobacco consumption in adults: analysis of data from 113 countries 
BMC Medicine  2015;13:194.
Smokeless tobacco is consumed in most countries in the world. In view of its widespread use and increasing awareness of the associated risks, there is a need for a detailed assessment of its impact on health. We present the first global estimates of the burden of disease due to consumption of smokeless tobacco by adults.
The burden attributable to smokeless tobacco use in adults was estimated as a proportion of the disability-adjusted life-years (DALYs) lost and deaths reported in the 2010 Global Burden of Disease study. We used the comparative risk assessment method, which evaluates changes in population health that result from modifying a population’s exposure to a risk factor. Population exposure was extrapolated from country-specific prevalence of smokeless tobacco consumption, and changes in population health were estimated using disease-specific risk estimates (relative risks/odds ratios) associated with it. Country-specific prevalence estimates were obtained through systematically searching for all relevant studies. Disease-specific risks were estimated by conducting systematic reviews and meta-analyses based on epidemiological studies.
We found adult smokeless tobacco consumption figures for 115 countries and estimated burden of disease figures for 113 of these countries. Our estimates indicate that in 2010, smokeless tobacco use led to 1.7 million DALYs lost and 62,283 deaths due to cancers of mouth, pharynx and oesophagus and, based on data from the benchmark 52 country INTERHEART study, 4.7 million DALYs lost and 204,309 deaths from ischaemic heart disease. Over 85 % of this burden was in South-East Asia.
Smokeless tobacco results in considerable, potentially preventable, global morbidity and mortality from cancer; estimates in relation to ischaemic heart disease need to be interpreted with more caution, but nonetheless suggest that the likely burden of disease is also substantial. The World Health Organization needs to consider incorporating regulation of smokeless tobacco into its Framework Convention for Tobacco Control.
Electronic supplementary material
The online version of this article (doi:10.1186/s12916-015-0424-2) contains supplementary material, which is available to authorized users.
PMCID: PMC4538761  PMID: 26278072
20.  Pediatric immunization-related safety incidents in primary care: A mixed methods analysis of a national database 
Vaccine  2015;33(32):3873-3880.
Children are scheduled to receive 18–20 immunizations before their 18th birthday in England and Wales; this approximates to 13 million vaccines administered per annum. Each immunization represents a potential opportunity for immunization-related error and effective immunization is imperative to maintain the public health benefit from immunization. Using data from a national reporting system, this study aimed to characterize pediatric immunization-related safety incident reports from primary care in England and Wales between 2002 and 2013.
A cross-sectional mixed methods study was undertaken. This comprised reading the free-text of incident reports and applying codes to describe incident type, potential contributory factors, harm severity, and incident outcomes. A subsequent thematic analysis was undertaken to interpret the most commonly occurring codes, such as those describing the incident, events leading up to it and reported contributory factors, within the contexts they were described.
We identified 1745 reports and most (n = 1077, 61.7%) described harm outcomes including three deaths, 67 reports of moderate harm and 1007 reports of low harm. Failure of timely vaccination was the potential cause of three child deaths from meningitis and pneumonia, and described in a further 113 reports. Vaccine administration incidents included the wrong number of doses (n = 476, 27.3%), wrong timing (n = 294, 16.8%), and wrong vaccine (n = 249, 14.3%). Documentation failures were frequently implicated. Socially and medically vulnerable children were commonly described.
This is the largest examination of reported contributory factors for immunization-related patient safety incidents in children. Our findings suggest investments in IT infrastructure to support data linkage and identification of risk predictors, development of consultation models that promote the role of parents in mitigating safety incidents, and improvement efforts to adapt and adopt best practices from elsewhere, are needed to mitigate future immunization-related patient safety incidents. These priorities are particularly pressing for vulnerable patient groups.
PMCID: PMC4518472  PMID: 26122580
Health services; Patient safety; Primary care; Public health; Quality improvement; NRLS, National Reporting and Learning System; WHO, World Health Organization
21.  Self-Management Support Interventions for Stroke Survivors: A Systematic Meta-Review 
PLoS ONE  2015;10(7):e0131448.
There is considerable policy interest in promoting self-management in patients with long-term conditions, but it remains uncertain whether these interventions are effective in stroke patients.
Systematic meta-review of the evidence for self-management support interventions with stroke survivors to inform provision of healthcare services.
We searched MEDLINE, EMBASE, CINAHL, PsychINFO, AMED, BNI, Database of Abstracts of Reviews for Effectiveness, and Cochrane Database of Systematic Reviews for systematic reviews of self-management support interventions for stroke survivors. Quality was assessed using the R-AMSTAR tool, and data extracted using a customised data extraction form. We undertook a narrative synthesis of the reviews' findings.
From 12,400 titles we selected 13 systematic reviews (published 2003-2012) representing 101 individual trials. Although the term ‘self-management’ was rarely used, key elements of self-management support such as goal setting, action planning, and problem solving were core components of therapy rehabilitation interventions. We found high quality evidence that supported self-management in the context of therapy rehabilitation delivered soon after the stroke event resulted in short-term (< 1 year) improvements in basic and extended activities of daily living, and a reduction in poor outcomes (dependence/death). There is some evidence that rehabilitation and problem solving interventions facilitated reintegration into the community.
Self-management terminology is rarely used in the context of stroke. However, therapy rehabilitation currently successfully delivers elements of self-management support to stroke survivors and their caregivers with improved outcomes. Future research should focus on managing the emotional, medical and social tasks of long-term survivorship.
PMCID: PMC4512724  PMID: 26204266
22.  Implementing supported self-management for asthma: a systematic review and suggested hierarchy of evidence of implementation studies 
BMC Medicine  2015;13:127.
Asthma self-management remains poorly implemented in clinical practice despite overwhelming evidence of improved healthcare outcomes, reflected in guideline recommendations over three decades. To inform delivery in routine care, we synthesised evidence from implementation studies of self-management support interventions.
We systematically searched eight electronic databases (1980 to 2012) and research registers, and performed snowball and manual searches for studies evaluating implementation of asthma self-management in routine practice. We included, and adapted systematic review methodology to reflect, a broad range of implementation study designs. We extracted data on study characteristics, process measures (for example, action plan ownership), asthma control (for example, patient reported control questionnaires, days off school/work, symptom-free days) and use of health services (for example, admissions, emergency department attendances, unscheduled consultations). We assessed quality using the validated Downs and Black checklist, and conducted a narrative synthesis informed by Kennedy’s whole systems theoretical approach (considering patient, practitioner and organisational components and the interaction between these).
We included 18 studies (6 randomised trials, 2 quasi-experimental studies, 8 with historical controls and 3 with retrospective comparators) from primary, secondary, community and managed care settings serving a total estimated asthma population of 800,000 people in six countries. In these studies, targeting professionals (n = 2) improved process, but had no clinically significant effect on clinical outcomes. Targeting patients (n = 6) improved some process measures, but had an inconsistent impact on clinical outcomes. Targeting the organisation (n = 3) improved process measures, but had little/no effect on clinical outcomes. Interventions that explicitly addressed patient, professional and organisational factors (n = 7) showed the most consistent improvement in both process and clinical outcomes. Authors highlighted the importance of health system commitment, skills training for professionals, patient education programmes supported by regular reviews, and on-going evaluation of implementation effectiveness.
Our methodology offers an exemplar of reviews synthesising the heterogeneous implementation literature. Effective interventions combined active engagement of patients, with training and motivation of professionals embedded within an organisation in which self-management is valued. Healthcare managers should consider how they can promote a culture of actively supporting self-management as a normal, expected, monitored and remunerated aspect of the provision of care.
Systematic review registration
PROSPERO (registration number: CRD42012002898) Accessed 24 May 2015
Electronic supplementary material
The online version of this article (doi:10.1186/s12916-015-0361-0) contains supplementary material, which is available to authorized users.
PMCID: PMC4465463  PMID: 26032941
Systematic review; Asthma self-management; Phase IV implementation studies; Dissemination and implementation
23.  Estimating the prevalence of aero-allergy and/or food allergy in infants, children and young people with moderate-to-severe atopic eczema/dermatitis in primary care: multi-centre, cross-sectional study 
We sought to determine the primary care-based prevalence of moderate-to-severe atopic eczema/dermatitis in children and to estimate what proportion had co-morbid aero-allergy and/or food allergy that was contributing to their atopic eczema/dermatitis.
Multi-centre, cross-sectional study.
Infants, children and young people aged between 0–17 years.
Primary Care.
General practice electronic health records were interrogated to identify children (0–17 years) with current moderate-to-severe atopic eczema/dermatitis. Eligible children were assessed by an allergy specialist nurse, this involving a detailed allergy history, examination and, if appropriate, measurement of total IgE and specific IgE to relevant aero-allergens and/or food allergens.
Main outcome measures
Prevalence of atopic eczema, moderate to severe atopic eczema, IgE-mediated atopic eczema.
We recruited eight practices, which together enrolled 16,877 children. Of these, 4331 (25.7%; 95% CI 25.0, 26.3) children had a recorded diagnosis of atopic eczema/dermatitis and 1316 (7.8%; 95% CI 7.4, 8.2) had treatment indicative of current moderate-to-severe atopic eczema/dermatitis. We recruited 159 children for clinical assessment, and complete data were available for 157. The clinical assessment revealed that 130/157 (82.8%) had no indication of IgE-mediated allergy contributing to their atopic eczema/dermatitis; the remaining 27/157 (17.2%; 95% CI 12.1, 23.9) were on clinical assessment considered to possibly have underlying IgE-mediated disease. Specific IgE tests were positive in 14/27 (51.9%; 95% CI 34.0, 69.3) children. Of the 14 children who tested positive, six (42.9%; 95% CI 21.4, 67.4) were positive to food allergens and six (42.9%; 95% CI 21.4, 67.4) to aero-allergens; the remaining two (14.3%; 95% CI 4.0, 40.0) were positive to both food and aero-allergens.
Although atopic eczema/dermatitis is a very common diagnosis in children in primary care, most appear to be relatively mild and/or transient. Only a small proportion of children had evidence of ongoing underlying IgE-mediated atopic eczema/dermatitis.
PMCID: PMC4480555  PMID: 25567768
Atopy; children ; eczema; epidemiology; general practice

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