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1.  Self-Management Support Interventions for Stroke Survivors: A Systematic Meta-Review 
PLoS ONE  2015;10(7):e0131448.
Background
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.
Design
Systematic meta-review of the evidence for self-management support interventions with stroke survivors to inform provision of healthcare services.
Methods
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.
Results
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.
Conclusions
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.
doi:10.1371/journal.pone.0131448
PMCID: PMC4512724  PMID: 26204266
2.  Implementing supported self-management for asthma: a systematic review and suggested hierarchy of evidence of implementation studies 
BMC Medicine  2015;13:127.
Background
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.
Methods
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).
Results
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.
Conclusions
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.
doi:10.1186/s12916-015-0361-0
PMCID: PMC4465463  PMID: 26032941
Systematic review; Asthma self-management; Phase IV implementation studies; Dissemination and implementation
3.  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 
Objective
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.
Design
Multi-centre, cross-sectional study.
Participants
Infants, children and young people aged between 0–17 years.
Setting
Primary Care.
Methods
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.
Results
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.
Conclusions
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.
doi:10.1177/0141076814562982
PMCID: PMC4480555  PMID: 25567768
Atopy; children ; eczema; epidemiology; general practice
5.  The NHS Health Check programme: implementation in east London 2009–2011 
BMJ Open  2015;5(4):e007578.
Objectives
To describe implementation and results from the National Health Service (NHS) Health Check programme.
Design
Three-year observational open cohort study: 2009–2011.
Participants
People of age 40–74 years eligible for an NHS Health Check.
Setting
139/143 general practices in three east London primary care trusts (PCTs) serving an ethnically diverse and socially disadvantaged population.
Method
Implementation was supported with education, IT support and performance reports. Tower Hamlets PCT additionally used managed practice networks and prior-stratification to call people at higher cardiovascular (CVD) risk first.
Main outcomes measures
Attendance, proportion of high-risk population on statins and comorbidities identified.
Results
Coverage 2009, 2010, 2011 was 33.9% (31 878/10 805), 60.6% (30 757/18 652) and 73.4% (21 194/28 890), respectively. Older people were more likely to attend than younger people. Attendance was similar across deprivation quintiles and was in accordance with population distributions of black African/Caribbean, South Asian and White ethnic groups. 1 in 10 attendees were at high-CVD risk (20% or more 10-year risk). In the two PCTs stratifying risk, 14.3% and 9.4% of attendees were at high-CVD risk compared to 8.6% in the PCT using an unselected invitation strategy. Statin prescription to people at high-CVD risk was higher in Tower Hamlets 48.9%, than in City and Hackney 23.1% or Newham 20.2%. In the 6 months following an NHS Health Check, 1349 new cases of hypertension, 638 new cases of diabetes and 89 new cases of chronic kidney disease (CKD) were diagnosed. This represents 1 new case of hypertension per 38 Checks, 1 new case of diabetes per 80 Checks and 1 new case of CKD per 568 Checks.
Conclusions
Implementation of the NHS Health Check programme in these localities demonstrates limited success. Coverage and treatment of those at high-CVD risk could be improved. Targeting invitations to people at high-CVD risk and managed practice networks in Tower Hamlets improved performance.
doi:10.1136/bmjopen-2015-007578
PMCID: PMC4401839  PMID: 25869692
PREVENTIVE MEDICINE; PRIMARY CARE; PUBLIC HEALTH
6.  Developing standards for reporting implementation studies of complex interventions (StaRI): a systematic review and e-Delphi 
Background
Dissemination and implementation of health care interventions are currently hampered by the variable quality of reporting of implementation research. Reporting of other study types has been improved by the introduction of reporting standards (e.g. CONSORT). We are therefore developing guidelines for reporting implementation studies (StaRI).
Methods
Using established methodology for developing health research reporting guidelines, we systematically reviewed the literature to generate items for a checklist of reporting standards. We then recruited an international, multidisciplinary panel for an e-Delphi consensus-building exercise which comprised an initial open round to revise/suggest a list of potential items for scoring in the subsequent two scoring rounds (scale 1 to 9). Consensus was defined a priori as 80% agreement with the priority scores of 7, 8, or 9.
Results
We identified eight papers from the literature review from which we derived 36 potential items. We recruited 23 experts to the e-Delphi panel. Open round comments resulted in revisions, and 47 items went forward to the scoring rounds. Thirty-five items achieved consensus: 19 achieved 100% agreement. Prioritised items addressed the need to: provide an evidence-based justification for implementation; describe the setting, professional/service requirements, eligible population and intervention in detail; measure process and clinical outcomes at population level (using routine data); report impact on health care resources; describe local adaptations to the implementation strategy and describe barriers/facilitators.
Over-arching themes from the free-text comments included balancing the need for detailed descriptions of interventions with publishing constraints, addressing the dual aims of reporting on the process of implementation and effectiveness of the intervention and monitoring fidelity to an intervention whilst encouraging adaptation to suit diverse local contexts.
Conclusions
We have identified priority items for reporting implementation studies and key issues for further discussion. An international, multidisciplinary workshop, where participants will debate the issues raised, clarify specific items and develop StaRI standards that fit within the suite of EQUATOR reporting guidelines, is planned.
Registration
The protocol is registered with Equator: http://www.equator-network.org/library/reporting-guidelines-under-development/#17.
doi:10.1186/s13012-015-0235-z
PMCID: PMC4393562  PMID: 25888928
Reporting standards; Implementation science; Dissemination and implementation; Complex interventions
7.  Mixed methods feasibility study for a trial of blood pressure telemonitoring for people who have had stroke/transient ischaemic attack (TIA) 
Trials  2015;16:117.
Background
Good blood pressure (BP) control reduces the risk of recurrence of stroke/transient ischaemic attack (TIA). Although there is strong evidence that BP telemonitoring helps achieve good control, none of the major trials have considered the effectiveness in stroke/TIA survivors. We therefore conducted a feasibility study for a trial of BP telemonitoring for stroke/TIA survivors with uncontrolled BP in primary care.
Method
Phase 1 was a pilot trial involving 55 patients stratified by stroke/TIA randomised 3:1 to BP telemonitoring for 6 months or usual care. Phase 2 was a qualitative evaluation and comprised semi-structured interviews with 16 trial participants who received telemonitoring and 3 focus groups with 23 members of stroke support groups and 7 carers.
Results
Overall, 125 patients (60 stroke patients, 65 TIA patients) were approached and 55 (44%) patients were randomised including 27 stroke patients and 28 TIA patients. Fifty-two participants (95%) attended the 6-month follow-up appointment, but one declined the second daytime ambulatory blood pressure monitoring (ABPM) measurement resulting in a 93% completion rate for ABPM − the proposed primary outcome measure for a full trial. Adherence to telemonitoring was good; of the 40 participants who were telemonitoring, 38 continued to provide readings throughout the 6 months. There was a mean reduction of 10.1 mmHg in systolic ABPM in the telemonitoring group compared with 3.8 mmHg in the control group, which suggested the potential for a substantial effect from telemonitoring. Our qualitative analysis found that many stroke patients were concerned about their BP and telemonitoring increased their engagement, was easy, convenient and reassuring.
Conclusions
A full-scale trial is feasible, likely to recruit well and have good rates of compliance and follow-up.
Trial Registration
ISRCTN61528726 15/12/2011.
Electronic supplementary material
The online version of this article (doi:10.1186/s13063-015-0628-y) contains supplementary material, which is available to authorized users.
doi:10.1186/s13063-015-0628-y
PMCID: PMC4404620  PMID: 25873155
Hypertension; Stroke; Transient Ischaemic Attack; General Practice; Home monitoring; Telemonitoring; Pilot Randomised Controlled Trial; Qualitative Research
8.  Estimating the incidence, prevalence and true cost of asthma in the UK: secondary analysis of national stand-alone and linked databases in England, Northern Ireland, Scotland and Wales—a study protocol 
BMJ Open  2014;4(11):e006647.
Introduction
Asthma is now one of the most common long-term conditions in the UK. It is therefore important to develop a comprehensive appreciation of the healthcare and societal costs in order to inform decisions on care provision and planning. We plan to build on our earlier estimates of national prevalence and costs from asthma by filling the data gaps previously identified in relation to healthcare and broadening the field of enquiry to include societal costs. This work will provide the first UK-wide estimates of the costs of asthma. In the context of asthma for the UK and its member countries (ie, England, Northern Ireland, Scotland and Wales), we seek to: (1) produce a detailed overview of estimates of incidence, prevalence and healthcare utilisation; (2) estimate health and societal costs; (3) identify any remaining information gaps and explore the feasibility of filling these and (4) provide insights into future research that has the potential to inform changes in policy leading to the provision of more cost-effective care.
Methods and analysis
Secondary analyses of data from national health surveys, primary care, prescribing, emergency care, hospital, mortality and administrative data sources will be undertaken to estimate prevalence, healthcare utilisation and outcomes from asthma. Data linkages and economic modelling will be undertaken in an attempt to populate data gaps and estimate costs. Separate prevalence and cost estimates will be calculated for each of the UK-member countries and these will then be aggregated to generate UK-wide estimates.
Ethics and dissemination
Approvals have been obtained from the NHS Scotland Information Services Division's Privacy Advisory Committee, the Secure Anonymised Information Linkage Collaboration Review System, the NHS South-East Scotland Research Ethics Service and The University of Edinburgh's Centre for Population Health Sciences Research Ethics Committee. We will produce a report for Asthma-UK, submit papers to peer-reviewed journals and construct an interactive map.
doi:10.1136/bmjopen-2014-006647
PMCID: PMC4225242  PMID: 25371419
EPIDEMIOLOGY; HEALTH ECONOMICS
9.  The rise and fall of England's National Programme for IT 
doi:10.1258/jrsm.2011.11k039
PMCID: PMC3206716  PMID: 22048671
10.  Using stakeholder perspectives to develop an ePrescribing toolkit for NHS Hospitals: a questionnaire study 
JRSM Open  2014;5(10):2054270414551658.
Summary
Objective
To evaluate how an online toolkit may support ePrescribing deployments in National Health Service hospitals, by assessing the type of knowledge-based resources currently sought by key stakeholders.
Design
Questionnaire-based survey of attendees at a national ePrescribing symposium.
Setting
2013 National ePrescribing Symposium in London, UK.
Participants
Eighty-four delegates were eligible for inclusion in the survey, of whom 70 completed and returned the questionnaire.
Main outcome measures
Estimate of the usefulness and type of content to be included in an ePrescribing toolkit.
Results
Interest in a toolkit designed to support the implementation and use of ePrescribing systems was high (n = 64; 91.4%). As could be expected given the current dearth of such a resource, few respondents (n = 2; 2.9%) had access or used an ePrescribing toolkit at the time of the survey. Anticipated users for the toolkit included implementation (n = 62; 88.6%) and information technology (n = 61; 87.1%) teams, pharmacists (n = 61; 87.1%), doctors (n = 58; 82.9%) and nurses (n = 56; 80.0%). Summary guidance for every stage of the implementation (n = 48; 68.6%), planning and monitoring tools (n = 47; 67.1%) and case studies of hospitals’ experiences (n = 45; 64.3%) were considered the most useful types of content.
Conclusions
There is a clear need for reliable and up-to-date knowledge to support ePrescribing system deployments and longer term use. The findings highlight how a toolkit may become a useful instrument for the management of knowledge in the field, not least by allowing the exchange of ideas and shared learning.
doi:10.1177/2054270414551658
PMCID: PMC4221951  PMID: 25383199
ePrescribing; toolkit; knowledge management; knowledge tools; stakeholder engagement
11.  Patients’ online access to their electronic health records and linked online services: a systematic interpretative review 
BMJ Open  2014;4(9):e006021.
Objectives
To investigate the effect of providing patients online access to their electronic health record (EHR) and linked transactional services on the provision, quality and safety of healthcare. The objectives are also to identify and understand: barriers and facilitators for providing online access to their records and services for primary care workers; and their association with organisational/IT system issues.
Setting
Primary care.
Participants
A total of 143 studies were included. 17 were experimental in design and subject to risk of bias assessment, which is reported in a separate paper. Detailed inclusion and exclusion criteria have also been published elsewhere in the protocol.
Primary and secondary outcome measures
Our primary outcome measure was change in quality or safety as a result of implementation or utilisation of online records/transactional services.
Results
No studies reported changes in health outcomes; though eight detected medication errors and seven reported improved uptake of preventative care. Professional concerns over privacy were reported in 14 studies. 18 studies reported concern over potential increased workload; with some showing an increase workload in email or online messaging; telephone contact remaining unchanged, and face-to face contact staying the same or falling. Owing to heterogeneity in reporting overall workload change was hard to predict. 10 studies reported how online access offered convenience, primarily for more advantaged patients, who were largely highly satisfied with the process when clinician responses were prompt.
Conclusions
Patient online access and services offer increased convenience and satisfaction. However, professionals were concerned about impact on workload and risk to privacy. Studies correcting medication errors may improve patient safety. There may need to be a redesign of the business process to engage health professionals in online access and of the EHR to make it friendlier and provide equity of access to a wider group of patients.
A1. Systematic review registration number
PROSPERO CRD42012003091.
doi:10.1136/bmjopen-2014-006021
PMCID: PMC4158217  PMID: 25200561
PRIMARY CARE
12.  Cardiovascular and neuropsychiatric safety of varenicline and bupropion compared with nicotine replacement therapy for smoking cessation: study protocol of a retrospective cohort study using the QResearch general practice database 
BMJ Open  2014;4(8):e005281.
Introduction
Cigarette smoking continues to be the leading cause of preventable death and is the main risk factor of major diseases such as chronic obstructive pulmonary disease (COPD). The best treatment to help smokers quit is a combination of behavioural support with pharmacotherapy. Varenicline is the newest drug on the market and has been shown to be effective in the general smoking population and in smokers with COPD. The safety profile of varenicline was initially established using standard approaches to pharmacovigilance, but postmarketing reports have raised concerns about a possible association between the use of varenicline and cardiovascular and neuropsychiatric events. Although recent studies have not confirmed such an association, further research is needed given the large number of smokers who are being prescribed varenicline, including important subgroups such as smokers with COPD who may be particularly vulnerable to side effects of drugs. The aim of this study is to assess the cardiovascular and neuropsychiatric safety of varenicline using data from the QResearch general practice (GP) database.
Methods and analysis
We will conduct a retrospective cohort study in the QResearch GP database. Patients will be categorised into three exposure groups: prescription of (1) varenicline, (2) bupropion or (3) nicotine replacement therapy (NRT Rx; =reference group). We will separately consider major incident neuropsychiatric and cardiovascular outcomes that occur during 6 months of follow-up using Cox proportional hazards models, adjusted for confounders. Furthermore, propensity score analysis will be used as an analytical approach to account for potential confounding by indication.
Ethics and dissemination
This work involves analysis of anonymised, routinely collected data. The protocol has been independently peer-reviewed by the QResearch Scientific Board and meets the requirements of the Trent research ethics committee. We plan to disseminate the results from this study via articles in international peer-reviewed journals and presentations at relevant national and international health conferences.
doi:10.1136/bmjopen-2014-005281
PMCID: PMC4156814  PMID: 25168037
Epidemiology; Mental Health
13.  Protocol for evaluation of the cost-effectiveness of ePrescribing systems and candidate prototype for other related health information technologies 
Background
This protocol concerns the assessment of cost-effectiveness of hospital health information technology (HIT) in four hospitals. Two of these hospitals are acquiring ePrescribing systems incorporating extensive decision support, while the other two will implement systems incorporating more basic clinical algorithms. Implementation of an ePrescribing system will have diffuse effects over myriad clinical processes, so the protocol has to deal with a large amount of information collected at various ‘levels’ across the system.
Methods/Design
The method we propose is use of Bayesian ideas as a philosophical guide.
Assessment of cost-effectiveness requires a number of parameters in order to measure incremental cost utility or benefit – the effectiveness of the intervention in reducing frequency of preventable adverse events; utilities for these adverse events; costs of HIT systems; and cost consequences of adverse events averted. There is no single end-point that adequately and unproblematically captures the effectiveness of the intervention; we therefore plan to observe changes in error rates and adverse events in four error categories (death, permanent disability, moderate disability, minimal effect). For each category we will elicit and pool subjective probability densities from experts for reductions in adverse events, resulting from deployment of the intervention in a hospital with extensive decision support. The experts will have been briefed with quantitative and qualitative data from the study and external data sources prior to elicitation. Following this, there will be a process of deliberative dialogues so that experts can “re-calibrate” their subjective probability estimates. The consolidated densities assembled from the repeat elicitation exercise will then be used to populate a health economic model, along with salient utilities. The credible limits from these densities can define thresholds for sensitivity analyses.
Discussion
The protocol we present here was designed for evaluation of ePrescribing systems. However, the methodology we propose could be used whenever research cannot provide a direct and unbiased measure of comparative effectiveness.
doi:10.1186/1472-6963-14-314
PMCID: PMC4118257  PMID: 25038609
ePrescribing; Health information technology; Cost-effectiveness; Adverse events; Bayesian elicitation; Probability densities
14.  Understanding experiences of participating in a weight loss lifestyle intervention trial: a qualitative evaluation of South Asians at high risk of diabetes 
BMJ Open  2014;4(6):e004736.
Objective
To explore the reasons for enrolling, experiences of participating and reasons for remaining in a family-based, cluster randomised controlled trial of a dietitian-delivered lifestyle modification intervention aiming to reduce obesity in South Asians at high risk of developing diabetes.
Design
Qualitative study using narrative interviews of a purposive sample of trial participants following completion of the intervention. Data were thematically analysed.
Setting
The intervention was conducted in Scotland and resulted in a modest decrease in weight, but did not statistically reduce the incidence of diabetes.
Participants
We conducted 21 narrative interviews with 24 participants (20 trial participants and four family volunteers).
Results
Many participants were motivated to participate because of: known family history of diabetes and the desire to better understand diabetes-related risks to their own and their family's health; ways to mitigate these risks and to benefit from personalised monitoring. Home-based interventions, communication in the participant's chosen language(s) and continuity in dietitians supported their continuing engagement with the trial. Adaptations in food choices were initially accommodated by participants, although social and faith-based responsibilities were reported as important barriers to persevering with agreed dietary goals. Many participants reported that increasing their level of physical activity was difficult given their long working hours, physically demanding employment and domestic commitments; this being compounded by Scotland's challenging climate and a related reluctance to exercise in the outdoors.
Conclusions
Although participants had strong personal interests in participation and found the information provided by dietitians useful, they nonetheless struggled to incorporate the dietary and exercise recommendations into their daily lives. In particular, increasing levels of physical exercise was described as an additional and in some cases unachievable burden. Consideration needs to be given to strengthening and supporting lifestyle interventions with community-based approaches in order to help overcome wider social and environmental factors.
doi:10.1136/bmjopen-2013-004736
PMCID: PMC4067864  PMID: 24951108
Diabetes & Endocrinology; Preventive Medicine; Public Health; Qualitative Research
15.  ‘Too much, too late’: mixed methods multi-channel video recording study of computerized decision support systems and GP prescribing 
Objective
Computerized decision support systems (CDSS) are commonly deployed to support prescribing, although over-riding of alerts by prescribers remains a concern. We aimed to understand how general practitioners (GPs) interact with prescribing CDSS in order to inform deliberation on how better to support prescribing decisions in primary care.
Materials and methods
Quantitative and qualitative analysis of interactions between GPs, patients, and computer systems using multi-channel video recordings of 112 primary care consultations with eight GPs in three UK practices.
Results
132 prescriptions were issued in the course of 73 of the consultations, of which 81 (61%) attracted at least one alert. Of the total of 117 alerts, only three resulted in the GP checking, but not altering, the prescription. CDSS provided information and safety alerts at the point of generating a prescription. This was ‘too much, too late’ as the majority of the ‘work’ of prescribing occurred prior to using the computer. By the time an alert appeared, the GP had formulated the problem(s), potentially spent several minutes considering, explaining, negotiating, and reaching agreement with the patient about the proposed treatment, and had possibly given instructions and printed an information leaflet.
Discussion
CDSS alerts do not coincide with the prescribing workflow throughout the whole GP consultation. Current systems interrupt to correct decisions that have already been taken, rather than assisting formulation of the management plan.
Conclusions
CDSS are likely to be more acceptable and effective if the prescribing support is provided much earlier in the process of generating a prescription.
doi:10.1136/amiajnl-2012-001484
PMCID: PMC3715350  PMID: 23470696
Clinical Computerised Decision Support (CDSS); Electronic Health Record; Prescribing Safety; Primary Care; Safety Alerts
16.  Ten key considerations for the successful implementation and adoption of large-scale health information technology 
The implementation of health information technology interventions is at the forefront of most policy agendas internationally. However, such undertakings are often far from straightforward as they require complex strategic planning accompanying the systemic organizational changes associated with such programs. Building on our experiences of designing and evaluating the implementation of large-scale health information technology interventions in the USA and the UK, we highlight key lessons learned in the hope of informing the on-going international efforts of policymakers, health directorates, healthcare management, and senior clinicians.
doi:10.1136/amiajnl-2013-001684
PMCID: PMC3715363  PMID: 23599226
17.  The use of global positional satellite location in dementia: a feasibility study for a randomised controlled trial 
BMC Psychiatry  2014;14:160.
Background
Getting lost outside is stressful for people with dementia and their caregivers and a leading cause of long-term institutionalisation. Although Global Positional Satellite (GPS) location has been promoted to facilitate safe walking, reduce caregivers’ anxiety and enable people with dementia to remain at home, there is little high quality evidence about its acceptability, effectiveness or cost-effectiveness. This observational study explored the feasibility of recruiting and retaining participants, and the acceptability of outcome measures, to inform decisions about the feasibility of a randomised controlled trial (RCT).
Methods
People with dementia who had been provided with GPS devices by local social-care services and their caregivers were invited to participate in this study. We undertook interviews with people with dementia, caregivers and professionals to explore the perceived utility and challenges of GPS location, and assessed quality of life (QoL) and mental health. We piloted three methods of calculating resource use: caregiver diary; bi-monthly telephone questionnaires; and interrogation of health and social care records. We asked caregivers to estimate the time spent searching if participants became lost before and whilst using GPS.
Results
Twenty people were offered GPS locations services by social-care services during the 8-month recruitment period. Of these, 14 agreed to be referred to the research team, 12 of these participated and provided data. Eight people with dementia and 12 caregivers were interviewed. Most participants and professionals were very positive about using GPS. Only one person completed a diary. Resource use, anxiety and depression and QoL questionnaires were considered difficult and were therefore declined by some on follow-up. Social care records were time consuming to search and contained many omissions. Caregivers estimated that GPS reduced searching time although the accuracy of this was not objectively verified.
Conclusions
Our data suggest that a RCT will face challenges not least that widespread enthusiasm for GPS among social-care staff may challenge recruitment and its ready availability may risk contamination of controls. Potential primary outcomes of a RCT should not rely on caregivers’ recall or questionnaire completion. Time spent searching (if this could be accurately captured) and days until long-term admission are potentially suitable outcomes.
doi:10.1186/1471-244X-14-160
PMCID: PMC4053578  PMID: 24885489
Dementia; Feasibility study; Global positional satellite location; Wandering
18.  Approaches to Recording Drug Allergies in Electronic Health Records: Qualitative Study 
PLoS ONE  2014;9(4):e93047.
Background
Drug allergy represent an important subset of adverse drug reactions that is worthy of attention because many of these reactions are potentially preventable with use of computerised decision support systems. This is however dependent on the accurate and comprehensive recording of these reactions in the electronic health record. The objectives of this study were to understand approaches to the recording of drug allergies in electronic health record systems.
Materials and Methods
We undertook a case study comprising of 21 in-depth interviews with a purposefully selected group of primary and secondary care clinicians, academics, and members of the informatics and drug regulatory communities, observations in four General Practices and an expert group discussion with 15 participants from the Allergy and Respiratory Expert Resource Group of the Royal College of General Practitioners.
Results
There was widespread acceptance among healthcare professionals of the need for accurate recording of drug allergies and adverse drug reactions. Most drug reactions were however likely to go unreported to and/or unrecognised by healthcare professionals and, even when recognised and reported, not all reactions were accurately recorded. The process of recording these reactions was not standardised.
Conclusions
There is considerable variation in the way drug allergies are recorded in electronic health records. This limits the potential of computerised decision support systems to help alert clinicians to the risk of further reactions. Inaccurate recording of information may in some instances introduce new problems as patients are denied treatments that they are erroneously believed to be allergic to.
doi:10.1371/journal.pone.0093047
PMCID: PMC3989180  PMID: 24740090
19.  Social support for South Asian Muslim parents with life-limiting illness living in Scotland: a multiperspective qualitative study 
BMJ Open  2014;4(2):e004252.
Objective
To explore experiences of social support needs among South Asian Muslim patients with life-limiting illness, living in Scotland, who are parents of young children.
Design
Secondary analysis of data from a multiperspective, longitudinal Scottish study involving in-depth semistructured interviews with patients, their nominated carers and healthcare professionals. Data were analysed using interpretive phenomenological analysis.
Setting
Edinburgh, Scotland.
Participants
South-Asian Muslim patients with life-limiting illness with children under the age of 18 (n=8), their carer (n=6) and their healthcare professional.
Main outcome measures
Access and provision of social support in palliative care.
Results
Open-ended qualitative interviews identified four main themes: (1) parental sadness over being unable to provide tangible support; (2) parental desire to continue to provide emotional support; (3) limited availability of informal social support networks; and (4) differing perspectives between healthcare professionals and patients on patient access to social support sources, with a subtheme being the capacity of male carers to provide social support.
South-Asian parents at the end of life had limited access to extended-network support. Gender roles appeared as challenging for healthcare providers who at times overestimated the amount of support a female carer could provide and underestimated the amount of support male carers provided. Implications for practice include the need for greater awareness by healthcare providers of the social support needs of ethnic minority and migrant parents with life-limiting illnesses and especially an awareness of the importance of the role of male and female carers. Further research is needed to explore how the timing of migration impacts the need for and availability of tangible and emotional informal social support among ethnic minority parents with life-limiting illness.
doi:10.1136/bmjopen-2013-004252
PMCID: PMC3918973  PMID: 24503303
Social support; Qualitative Research; Supportive Care; Palliative Care; Minority Groups
20.  Preterm Birth and Childhood Wheezing Disorders: A Systematic Review and Meta-Analysis 
PLoS Medicine  2014;11(1):e1001596.
In a systematic review and meta-analysis, Jasper Been and colleagues investigate the association between preterm birth and the development of wheezing disorders in childhood.
Please see later in the article for the Editors' Summary
Background
Accumulating evidence implicates early life factors in the aetiology of non-communicable diseases, including asthma/wheezing disorders. We undertook a systematic review investigating risks of asthma/wheezing disorders in children born preterm, including the increasing numbers who, as a result of advances in neonatal care, now survive very preterm birth.
Methods and Findings
Two reviewers independently searched seven online databases for contemporaneous (1 January 1995–23 September 2013) epidemiological studies investigating the association between preterm birth and asthma/wheezing disorders. Additional studies were identified through reference and citation searches, and contacting international experts. Quality appraisal was undertaken using the Effective Public Health Practice Project instrument. We pooled unadjusted and adjusted effect estimates using random-effects meta-analysis, investigated “dose–response” associations, and undertook subgroup, sensitivity, and meta-regression analyses to assess the robustness of associations.
We identified 42 eligible studies from six continents. Twelve were excluded for population overlap, leaving 30 unique studies involving 1,543,639 children. Preterm birth was associated with an increased risk of wheezing disorders in unadjusted (13.7% versus 8.3%; odds ratio [OR] 1.71, 95% CI 1.57–1.87; 26 studies including 1,500,916 children) and adjusted analyses (OR 1.46, 95% CI 1.29–1.65; 17 studies including 874,710 children). The risk was particularly high among children born very preterm (<32 wk gestation; unadjusted: OR 3.00, 95% CI 2.61–3.44; adjusted: OR 2.81, 95% CI 2.55–3.12). Findings were most pronounced for studies with low risk of bias and were consistent across sensitivity analyses. The estimated population-attributable risk of preterm birth for childhood wheezing disorders was ≥3.1%.
Key limitations related to the paucity of data from low- and middle-income countries, and risk of residual confounding.
Conclusions
There is compelling evidence that preterm birth—particularly very preterm birth—increases the risk of asthma. Given the projected global increases in children surviving preterm births, research now needs to focus on understanding underlying mechanisms, and then to translate these insights into the development of preventive interventions.
Review Registration
PROSPERO CRD42013004965
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Most pregnancies last around 40 weeks, but worldwide, more than 11% of babies are born before 37 weeks of gestation (the period during which a baby develops in its mother's womb). Preterm birth is a major cause of infant death—more than 1 million babies die annually from preterm birth complications—and the number of preterm births is increasing globally. Multiple pregnancies, infections, and chronic (long-term) maternal conditions such as diabetes can all cause premature birth, but the cause of many preterm births is unknown. The most obvious immediate complication that is associated with preterm birth is respiratory distress syndrome. This breathing problem, which is more common in early preterm babies than in near-term babies, occurs because the lungs of premature babies are structurally immature and lack pulmonary surfactant, a unique mixture of lipids and proteins that coats the inner lining of the lungs and helps to prevent the collapse of the small air sacs in the lungs that absorb oxygen from the air. Consequently, preterm babies often need help with their breathing and oxygen supplementation.
Why Was This Study Done?
Improvements in the management of prematurity mean that more preterm babies survive today than in the past. However, accumulating evidence suggests that early life events are involved in the subsequent development of non-communicable diseases (non-infectious chronic diseases). Given the increasing burden of preterm birth, a better understanding of the long-term effects of preterm birth is essential. Here, the researchers investigate the risks of asthma and wheezing disorders in children who are born preterm by undertaking a systematic review (a study that uses predefined criteria to identify all the research on a given topic) and a meta-analysis (a statistical method for combining the results of several studies). Asthma is a chronic condition that is caused by inflammation of the airways. In people with asthma, the airways can react very strongly to allergens such as animal fur and to irritants such as cigarette smoke. Exercise, cold air, and infections can also trigger asthma attacks, which can sometimes be fatal. The symptoms of asthma include wheezing (a high-pitched whistling sound during breathing), coughing, chest tightness, and shortness of breath. Asthma cannot be cured, but drugs can relieve its symptoms and prevent acute asthma attacks.
What Did the Researchers Do and Find?
The researchers identified 30 studies undertaken between 1995 and the present (a time span chosen to allow for recent changes in the management of prematurity) that investigated the association between preterm birth and asthma/wheezing disorders in more than 1.5 million children. Across the studies, 13.7% of preterm babies developed asthma/wheezing disorders during childhood, compared to only 8.3% of babies born at term. Thus, the risk of preterm babies developing asthma or a wheezing disorder during childhood was 1.71 times higher than the risk of term babies developing these conditions (an unadjusted odds ratio [OR] of 1.71). In analyses that allowed for confounding factors—other factors that affect the risk of developing asthma/wheezing disorders such as maternal smoking—the risk of preterm babies developing asthma or a wheezing disorder during childhood was 1.46 times higher than that of babies born at term (an adjusted OR of 1.46). Notably, compared to children born at term, children born very early (before 32 weeks of gestation) had about three times the risk of developing asthma/wheezing disorders in unadjusted and adjusted analyses. Finally, the population-attributable risk of preterm birth for childhood wheezing disorders was more than 3.1%. That is, if no preterm births had occurred, there would have been more than a 3.1% reduction in childhood wheezing disorders.
What Do These Findings Mean?
These findings strongly suggest that preterm birth increases the risk of asthma and wheezing disorders during childhood and that the risk of asthma/wheezing disorders increases as the degree of prematurity increases. The accuracy of these findings may be affected, however, by residual confounding. That is, preterm children may share other, unknown characteristics that increase their risk of developing asthma/wheezing disorders. Moreover, the generalizability of these findings is limited by the lack of data from low- and middle-income countries. However, given the projected global increases in children surviving preterm births, these findings highlight the need to undertake research into the mechanisms underlying the association between preterm birth and asthma/wheezing disorders and the need to develop appropriate preventative and therapeutic measures.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001596.
The March of Dimes, a nonprofit organization for pregnancy and baby health, provides information on preterm birth (in English and Spanish)
Nemours, another nonprofit organization for child health, also provides information (in English and Spanish) on premature babies and on asthma (including personal stories)
The UK National Health Service Choices website provides information about premature labor and birth and a real story about having a preterm baby; it provides information about asthma in children (including real stories)
The MedlinePlus Encyclopedia has pages on preterm birth, asthma, asthma in children, and wheezing (in English and Spanish); MedlinePlus provides links to further information on premature birth, asthma, and asthma in children (in English and Spanish)
doi:10.1371/journal.pmed.1001596
PMCID: PMC3904844  PMID: 24492409
21.  A Qualitative Exploration of Workarounds Related to the Implementation of National Electronic Health Records in Early Adopter Mental Health Hospitals 
PLoS ONE  2014;9(1):e77669.
Aims
To investigate the perceptions and reported practices of mental health hospital staff using national hospital electronic health records (EHRs) in order to inform future implementations, particularly in acute mental health settings.
Methods
Thematic analysis of interviews with a wide range of clinical, information technology (IT), managerial and other staff at two early adopter mental health National Health Service (NHS) hospitals in London, UK, implementing national EHRs.
Results
We analysed 33 interviews. We first sought out examples of workarounds, such as delayed data entry, entering data in wrong places and individuals using the EHR while logged in as a colleague, then identified possible reasons for the reported workarounds. Our analysis identified four main categories of factors contributing to workarounds (i.e., operational, cultural, organisational and technical). Operational factors included poor system integration with existing workflows and the system not meeting users' perceived needs. Cultural factors involved users' competence with IT and resistance to change. Organisational factors referred to insufficient organisational resources and training, while technical factors included inadequate local technical infrastructure. Many of these factors, such as integrating the EHR system with day-to-day operational processes, staff training and adequate local IT infrastructure, were likely to apply to system implementations in various settings, but we also identified factors that related particularly to implementing EHRs in mental health hospitals, for example: EHR system incompatibility with IT systems used by mental health–related sectors, notably social services; the EHR system lacking specific, mental health functionalities and options; and clinicians feeling unable to use computers while attending to distressed psychiatric patients.
Conclusions
A better conceptual model of reasons for workarounds should help with designing, and supporting the implementation and adoption of, EHRs for use in hospital mental health settings.
doi:10.1371/journal.pone.0077669
PMCID: PMC3894172  PMID: 24454678
22.  International consensus on (ICON) anaphylaxis 
ICON: Anaphylaxis provides a unique perspective on the principal evidence-based anaphylaxis guidelines developed and published independently from 2010 through 2014 by four allergy/immunology organizations. These guidelines concur with regard to the clinical features that indicate a likely diagnosis of anaphylaxis -- a life-threatening generalized or systemic allergic or hypersensitivity reaction.
They also concur about prompt initial treatment with intramuscular injection of epinephrine (adrenaline) in the mid-outer thigh, positioning the patient supine (semi-reclining if dyspneic or vomiting), calling for help, and when indicated, providing supplemental oxygen, intravenous fluid resuscitation and cardiopulmonary resuscitation, along with concomitant monitoring of vital signs and oxygenation. Additionally, they concur that H1-antihistamines, H2-antihistamines, and glucocorticoids are not initial medications of choice.
For self-management of patients at risk of anaphylaxis in community settings, they recommend carrying epinephrine auto-injectors and personalized emergency action plans, as well as follow-up with a physician (ideally an allergy/immunology specialist) to help prevent anaphylaxis recurrences.
ICON: Anaphylaxis describes unmet needs in anaphylaxis, noting that although epinephrine in 1 mg/mL ampules is available worldwide, other essentials, including supplemental oxygen, intravenous fluid resuscitation, and epinephrine auto-injectors are not universally available.
ICON: Anaphylaxis proposes a comprehensive international research agenda that calls for additional prospective studies of anaphylaxis epidemiology, patient risk factors and co-factors, triggers, clinical criteria for diagnosis, randomized controlled trials of therapeutic interventions, and measures to prevent anaphylaxis recurrences. It also calls for facilitation of global collaborations in anaphylaxis research.
In addition to confirming the alignment of major anaphylaxis guidelines, ICON: Anaphylaxis adds value by including summary tables and citing 130 key references. It is published as an information resource about anaphylaxis for worldwide use by healthcare professionals, academics, policy-makers, patients, caregivers, and the public.
doi:10.1186/1939-4551-7-9
PMCID: PMC4038846  PMID: 24920969
Anaphylaxis; Acute systemic allergic reaction; Epinephrine (adrenaline); H1-antihistamines; H2-antihistamines; Glucocorticoids; Food allergy; Venom allergy; Drug allergy; Exercise-induced anaphylaxis; Idiopathic anaphylaxis
23.  Investigating the cost-effectiveness of health information technologies: a systematic review protocol 
BMJ Open  2013;3(12):e003737.
Introduction
There is a need to develop new, more cost-effective models of healthcare and in this vein there is a considerable international interest in exploiting the potential offered by major developments in health information technologies (HITs). Very substantial investments are, as a result, now being made globally, but these still probably only represent a fraction of the investments needed if healthcare is to make the transition from the paper to the digital era. Investing greater resources is, however, inherently challenging and unpopular at a time of financial austerity and this is furthermore complicated by the thus far variable evidence of health benefits and demonstrable short-term to medium-term returns associated with investments in HITs.
Objectives
Building on our related systematic overviews investigating the impact of HITs, we now seek to estimate the cost-effectiveness of HITs and as a secondary aim to identify potentially transferable lessons in relation to how to realise returns on investments in these technologies.
Methods
We will conduct a systematic review to identify the empirical evidence base surrounding the return on investments from implementing HITs. Two reviewers will independently search major international databases for published, unpublished and on-going experimental and quasi-experimental studies of interest published during the period 1990–2013. These searches of bibliographic databases will be supplemented by contacting an international panel of experts. There will be no restriction on the language of publication of studies. Studies will be critically appraised using the Critical Appraisal Skills Programme (CASP) Economic Evaluations checklist. In view of the anticipated heterogeneity in intervention investigated, study design and health system contexts, we will undertake a descriptive, narrative and interpretative synthesis of data.
Ethics and dissemination
Ethical approval is not required.
Results
These will be presented in one manuscript. The protocol is registered with the International Prospective Register for Systematic Reviews (PROSPERO) CRD42013005294.
doi:10.1136/bmjopen-2013-003737
PMCID: PMC3884844  PMID: 24345899
25.  Integrating Telehealth Care-Generated Data With the Family Practice Electronic Medical Record: Qualitative Exploration of the Views of Primary Care Staff 
Background
Telehealth care is increasingly being employed in the management of long-term illness. Current systems are largely managed via “stand-alone” websites, which require additional log-ons for clinicians to view their patients’ symptom records and physiological measurements leading to frustrating delays and sometimes failure to engage with the record. However, there are challenges to the full integration of patient-acquired data into family physicians’ electronic medical records (EMR) in terms of reliability, how such data can best be summarized and presented to avoid overload to the clinicians, and how clarity of responsibility is managed when multiple agencies are involved.
Objective
We aimed to explore the views of primary care clinicians on the acceptability, clinical utility, and, in particular, the benefits and risks of integrating patient-generated telehealth care data into the family practice EMR and to explore how these data should be summarized and presented in order to facilitate use in routine care.
Methods
In our qualitative study, we carried out semi-structured interviews with clinicians with experience of and naïve to telehealth care following demonstration of pilot software, which illustrated various methods by which data could be incorporated into the EMR.
Results
We interviewed 20 clinicians and found 2 overarching themes of “workload” and “safety”. Although clinicians were largely positive about integrating telehealth care data into the EMR, they were concerned about the potential increased workload and safety issues, particularly in respect to error due to data overload. They suggested these issues could be mitigated by good system design that summarized and presented data such that they facilitated seamless integration with clinicians’ current routine processes for managing data flows, and ensured clear lines of communication and responsibility between multiple professionals involved in patients’ care.
Conclusions
Family physicians and their teams are likely to be receptive to and see the benefits of integrating telehealth-generated data into the EMR. Our study identified some of the key challenges that must be overcome to facilitate integration of telehealth care data. This work particularly underlines the importance of actively engaging with clinicians to ensure that systems are designed that align well with existing practice data-flow management systems and facilitate safe multiprofessional patient care.
doi:10.2196/ijmr.2820
PMCID: PMC3869047  PMID: 24280631
telehealth care; family practice; data management

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