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1.  Process evaluation of a point-of-care cluster randomised trial using a computer-delivered intervention to reduce antibiotic prescribing in primary care 
Background
The study aimed to conduct a process evaluation for a cluster randomised trial of a computer-delivered, point-of-care intervention to reduce antibiotic prescribing in primary care. The study aimed to evaluate both the intervention and implementation of the trial.
Methods
The intervention comprised a set of electronic educational and decision support tools that were remotely installed and activated during consultations with patients with acute respiratory infections over a 12 month intervention period. A mixed method evaluation was conducted with 103 general practitioners (GPs) who participated in the trial. Semi-structured telephone interviews were conducted with 20 GPs who had been in the intervention group of the trial and 4 members of the implementation staff. Questionnaires, consisting of both intervention evaluation and theory-based measures, were self-administered to 83 GPs (56 control group and 27 intervention group).
Results
Interviews suggested that a key factor influencing GPs’ use of the intervention appeared to be their awareness of the implementation of the system into their practice. GPs who were aware of the implementation of the intervention reported feeling confident in using it if they chose to and understood the purpose of the intervention screens. However, GPs who were unaware that the intervention would be appearing often reported feeling confused when they saw the messages appear on the screen and not fully understanding what they were for or how they could be used. Intervention evaluation questionnaires indicated that GPs were satisfied with the usability of the prompts, and theory-based measures revealed that intervention group GPs reported higher levels of self-efficacy in managing RTI patients according to recommended guidelines compared to GPs in the control group.
Conclusions
Remote installation of a computer-delivered intervention for use at the point-of-care was feasible and acceptable. Additional measures to promote awareness of the intervention may be required to promote health care professionals’ utilisation of the intervention and these might sometimes compromise the pragmatic intention of a trial.
Trial registration
ISRCTN47558792 (registered on 17 March 2010).
doi:10.1186/s12913-014-0594-1
PMCID: PMC4260184
Cluster trial; Pragmatic trial; Point of care; Antibiotic utilisation; Primary care; Implementation science
2.  Point of care testing for urinary tract infection in primary care (POETIC): protocol for a randomised controlled trial of the clinical and cost effectiveness of FLEXICULT™ informed management of uncomplicated UTI in primary care 
BMC Family Practice  2014;15(1):187.
Background
Urinary tract infections (UTI) are the most frequent bacterial infection affecting women and account for about 15% of antibiotics prescribed in primary care. However, some women with a UTI are not prescribed antibiotics or are prescribed the wrong antibiotics, while many women who do not have a microbiologically confirmed UTI are prescribed antibiotics. Inappropriate antibiotic prescribing unnecessarily increases the risk of side effects and the development of antibiotic resistance, and wastes resources.
POETIC is a randomised controlled trial of a Point Of Care Test (POCT) (Flexicult™) guided UTI management strategy for use in primary care, which may help General Practitioners more effectively decide both whether or not to prescribe antibiotics, and if so, to select the most appropriate antibiotic.
Methods/design
614 adult female patients will be recruited from four primary care research networks (Wales, England, Spain, the Netherlands) and individually randomised to either POCT guided care or the guideline-informed ‘standard care’ arm. Urine and stool samples (where possible) will be obtained at presentation (day 1) and two weeks later for microbiological analysis. All participants will be followed up on the course of their illness and their quality of life, using a 2 week self-completed symptom diary. At 3 months, a primary care notes review will be conducted for evidence of further evidence of treatment failures, recurrence, complications, hospitalisations and health service costs.
The primary objective is to compare appropriate antibiotic use on day 3 between the POCT and standard care arms using multi-level logistic regression to produce an odds ratio and associated 95% confidence interval. Costs of the two management approaches will be assessed in terms of the primary outcome.
Discussion
Although the Flexicult™ POCT is used in some countries in routine primary care, it’s clinical and cost effectiveness has never been evaluated in a randomised clinical trial. If shown to be effective, the use of this POCT could benefit individual sufferers and provide evidence for health care authorities to develop evidence based policies to combat the spread and impact of the unprecedented rise of infections caused by antibiotic resistant bacteria in Europe.
Trial registration number
ISRCTN65200697 (Registered 10 September 2013).
doi:10.1186/s12875-014-0187-4
PMCID: PMC4251943  PMID: 25425162
Urinary Tract Infection; Primary care; Adult women; Point-of-care-test; Near-patient testing; Antibiotic resistance; Cost effectiveness
3.  Continued high rates of antibiotic prescribing to adults with respiratory tract infection: survey of 568 UK general practices 
BMJ Open  2014;4(10):e006245.
Objectives
Overutilisation of antibiotics may contribute to the emergence of antimicrobial drug resistance, a growing international concern. This study aimed to analyse the performance of UK general practices with respect to antibiotic prescribing for respiratory tract infections (RTIs) among young and middle-aged adults.
Setting
Data are reported for 568 UK general practices contributing to the Clinical Practice Research Datalink.
Participants
Participants were adults aged 18–59 years. Consultations were identified for acute upper RTIs including colds, cough, otitis-media, rhino-sinusitis and sore throat.
Primary and secondary outcome measures
For each consultation, we identified whether an antibiotic was prescribed. The proportion of RTI consultations with antibiotics prescribed was estimated.
Results
There were 568 general practices analysed. The median general practice prescribed antibiotics at 54% of RTI consultations. At the highest prescribing 10% of practices, antibiotics were prescribed at 69% of RTI consultations. At the lowest prescribing 10% of practices, antibiotics were prescribed at 39% RTI consultations. The median practice prescribed antibiotics at 38% of consultations for ‘colds and upper RTIs’, 48% for ‘cough and bronchitis’, 60% for ‘sore throat’, 60% for ‘otitis-media’ and 91% for ‘rhino-sinusitis’. The highest prescribing 10% of practices issued antibiotic prescriptions at 72% of consultations for ‘colds’, 67% for ‘cough’, 78% for ‘sore throat’, 90% for ‘otitis-media’ and 100% for ‘rhino-sinusitis’.
Conclusions
Most UK general practices prescribe antibiotics to young and middle-aged adults with respiratory infections at rates that are considerably in excess of what is clinically justified. This will fuel antibiotic resistance.
doi:10.1136/bmjopen-2014-006245
PMCID: PMC4212213  PMID: 25348424
PUBLIC HEALTH
4.  Understanding Usage of a Hybrid Website and Smartphone App for Weight Management: A Mixed-Methods Study 
Background
Advancements in mobile phone technology offer huge potential for enhancing the timely delivery of health behavior change interventions. The development of smartphone-based health interventions (apps) is a rapidly growing field of research, yet there have been few longitudinal examinations of how people experience and use these apps within their day-to-day routines, particularly within the context of a hybrid Web- and app-based intervention.
Objective
This study used an in-depth mixed-methods design to examine individual variation in (1) impact on self-reported goal engagement (ie, motivation, self-efficacy, awareness, effort, achievement) of access to a weight management app (POWeR Tracker) when provided alongside a Web-based weight management intervention (POWeR) and (2) usage and views of POWeR Tracker.
Methods
Thirteen adults were provided access to POWeR and were monitored over a 4-week period. Access to POWeR Tracker was provided in 2 alternate weeks (ie, weeks 1 and 3 or weeks 2 and 4). Participants’ goal engagement was measured daily via self-report. Mixed effects models were used to examine change in goal engagement between the weeks when POWeR Tracker was and was not available and whether the extent of change in goal engagement varied between individual participants. Usage of POWeR and POWeR Tracker was automatically recorded for each participant. Telephone interviews were conducted and analyzed using inductive thematic analysis to further explore participants’ experiences using POWeR and POWeR Tracker.
Results
Access to POWeR Tracker was associated with a significant increase in participants’ awareness of their eating (β1=0.31, P=.04) and physical activity goals (β1=0.28, P=.03). The level of increase varied between individual participants. Usage data showed that participants used the POWeR website for similar amounts of time during the weeks when POWeR Tracker was (mean 29 minutes, SD 31 minutes) and was not available (mean 27 minutes, SD 33 minutes). POWeR Tracker was mostly accessed in short bursts (mean 3 minutes, SD 2 minutes) during convenient moments or moments when participants deemed the intervention content most relevant. The qualitative data indicated that nearly all participants agreed that it was more convenient to access information on-the-go via their mobiles compared to a computer. However, participants varied in their views and usage of the Web- versus app-based components and the informational versus tracking tools provided by POWeR Tracker.
Conclusions
This study provides evidence that smartphones have the potential to improve individuals’ engagement with their health-related goals when used as a supplement to an existing online intervention. The perceived convenience of mobile access to information does not appear to deter use of Web-based interventions or strengthen the impact of app access on goal engagement. A mixed-methods design enabled exploration of individual variation in daily usage of the app-based tools.
doi:10.2196/jmir.3579
PMCID: PMC4259922  PMID: 25355131
qualitative research; weight loss; behavioral research; mobile apps; Internet; health; program acceptability; behavior; mixed-methods
5.  Oral corticosteroid use for clinical and cost-effective symptom relief of sore throat: study protocol for a randomized controlled trial 
Trials  2014;15(1):365.
Background
Management of acute sore throat poses a significant burden on UK general practices, with almost 10% of registered patients attending their GP with sore throat every year. Nearly half of all patients presenting with acute sore throat are treated with antibiotics, despite their limited effect. In a recent systematic review we demonstrated that a single dose of steroids reduced the severity and time to resolution of sore throat. However, all of the trials included looked at the use of steroids alongside antibiotics and only one was in a primary care setting. This trial aims to assess the efficacy and cost-effectiveness of a single oral dose of corticosteroids on symptoms of sore throat in patients receiving either a delayed antibiotic prescription or no antibiotics at all in UK primary care.
Methods/Design
A double-blind, two arm, randomized, placebo controlled trial in adults (≥18 years of age) presenting to primary care with acute sore throat (
Discussion
This will be the first randomized controlled trial of oral corticosteroids in adults presenting to primary care with sore throat in the UK, and the first to examine the clinical and cost-effectiveness of oral corticosteroids for the treatment of sore throat in the absence of antibiotics.
Trial registration
This trial is registered with Current Controlled Trials on 26 March 2013, registration number: ISRCTN17435450.
Electronic supplementary material
The online version of this article (doi:10.1186/1745-6215-15-365) contains supplementary material, which is available to authorized users.
doi:10.1186/1745-6215-15-365
PMCID: PMC4182852  PMID: 25238785
Sore Throat; Steroid; Antibiotics; Delayed Antibiotic Prescription; Dexamethasone; Same Day Recruitment; Adults; Randomized; Placebo-controlled
doi:10.3399/bjgp13X670624
PMCID: PMC3722810  PMID: 23972176
The British Journal of General Practice  2014;64(625):e509-e515.
Background
Patients with lung or colorectal cancer often present late and have a poor prognosis. Identifying diagnostic indicators to optimally assess the risk of these cancers in primary care would support early identification and timely referral for patients at increased risk.
Aim
To obtain consensus regarding potential diagnostic indicators that are important for assessing the risk of lung or colorectal cancer in primary care consulters presenting with lung or abdominal symptoms.
Design and setting
A Delphi study was conducted with 28 participants from primary and secondary care and academic settings in the UK and Europe.
Method
Indicators were obtained from systematic reviews, recent primary studies and consultation with experts prior to the Delphi study being conducted. Over three rounds, participants rated each diagnostic indicator in terms of its importance, ranked them in order of importance, and rated each item as crucial or not crucial to assess during a GP consultation.
Results
The final round resulted in 25 items remaining for each type of cancer, including established cancer symptoms such as rectal bleeding for colorectal cancer and haemoptysis for lung cancer, but also less frequently used indicators such as patients’ concerns about cancer.
Conclusion
This study highlights the items clinicians feel would be most crucial to include in the clinical assessment of primary care patients, a number of which have rarely been noted in the previous literature. Their importance in assessing the risk of lung or colorectal cancer will be tested as part of a large prospective cohort study (CANDID).
doi:10.3399/bjgp14X681001
PMCID: PMC4111344  PMID: 25071064
Delphi technique; neoplasms; primary health care; referral and consultation
BMJ Open  2014;4(7):e005871.
Introduction
Dizziness is highly prevalent in older adults and can lead to falls, fear of falling, loss of confidence, anxiety and depression. Vestibular rehabilitation (VR) exercises are effective in reducing dizziness due to vestibular dysfunction, but access to trained therapists is limited. Providing dizzy patients with booklets teaching them how to carry out VR exercises has been shown to be a cost-effective way of managing dizziness in primary care. Internet-based intervention delivery has many advantages over paper-based methods, including the provision of video instructions, automated tailoring and symptom-related feedback. This trial will examine whether an internet-based VR intervention is (1) effective in reducing dizziness and (2) a cost-effective primary care treatment option.
Methods/analysis
This will be a single blind, randomised controlled trial carried out in UK primary care. A stand-alone internet-based VR intervention will be compared with routine care in 262 dizzy patients aged 50 years and over. Measures will be taken at baseline, 3 and 6 months. Our primary outcome measure will be the effectiveness of the intervention in reducing dizziness symptoms compared with routine care at 6 months. Cost-effectiveness will be examined along with the effect of the intervention on dizziness-related disability and symptoms of depression and anxiety. Psychological process variables including expectancy, self-efficacy and acceptance will be explored in relation to adherence and symptom reduction.
Ethics/dissemination
This trial has undergone ethical scrutiny and been approved by an NHS Research Ethics Committee, Southampton A REC Reference: 13/SC/0119. The findings of this trial will be disseminated to the scientific community through presentations at national and international conferences, and by publishing in peer review journals. Findings will be disseminated to the public through targeted press releases. This trial will provide valuable information on the role of internet interventions in facilitating self-management in older adults.
Trial registration number
ISRCTN: 86912968.
doi:10.1136/bmjopen-2014-005871
PMCID: PMC4120362  PMID: 25052178
Otolaryngology
BMJ Open  2014;4(6):e005548.
Introduction
Getting the results of research implemented into routine healthcare is often a challenge. The disconnect between the development and implementation of evidence into practice is called the ‘second translational gap’ and is particularly apparent in primary care. To address this gap, we plan to identify, summarise and synthesise currently available evidence by undertaking a systematic review of reviews to: (1) explore barriers and facilitators of implementation of research evidence or complex interventions, and (2) assess the effectiveness of strategies in facilitating implementation of complex interventions in primary care.
Methods and analysis
This is a protocol for a systematic review of reviews. We will search MEDLINE, EMBASE, the Cochrane Library, CINAHL and PsycINFO up until December 2013. We will check reference lists of included studies for further studies. Two authors will independently screen the titles and abstracts identified from the search; any discrepancies will be resolved by discussion and consensus. Full-text papers will be obtained and relevant reviews will be selected against inclusion criteria. Eligible reviews have to be based on predominantly primary care in developed countries and examine either factors to implementation or, the effectiveness of strategies to optimise implementation. Data from eligible reviews will be extracted using standardised data abstraction forms. For barriers and facilitators, data will be synthesised using an interpretative meta-synthesis approach. For implementation strategies, findings will be summarised and described narratively and synthesised using a framework approach. All findings will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
Ethics and dissemination
Ethical approval is not required. The review findings will inform the work of the design and implementation of future studies and will be of interest to a wide audience including health professionals, researchers, health service or commissioning managers and policymakers.
Trial registration number
Protocol registration number (PROSPERO CRD42014009410).
doi:10.1136/bmjopen-2014-005548
PMCID: PMC4067819  PMID: 24958212
Primary Care; Public Health
BMC Public Health  2014;14:589.
Background
Non-pharmaceutical public health interventions may provide simple, low-cost, effective ways of minimising the transmission and impact of acute respiratory infections in pandemic and non-pandemic contexts. Understanding what influences the uptake of non-pharmaceutical interventions such as hand and respiratory hygiene, mask wearing and social distancing could help to inform the development of effective public health advice messages. The aim of this synthesis was to explore public perceptions of non-pharmaceutical interventions that aim to reduce the transmission of acute respiratory infections.
Methods
Five online databases (MEDLINE, PsycINFO, CINAHL, EMBASE and Web of Science) were systematically searched. Reference lists of articles were also examined. We selected papers that used a qualitative research design to explore perceptions and beliefs about non-pharmaceutical interventions to reduce transmission of acute respiratory infections. We excluded papers that only explored how health professionals or children viewed non-pharmaceutical respiratory infection control. Three authors performed data extraction and assessment of study quality. Thematic analysis and components of meta-ethnography were adopted to synthesise findings.
Results
Seventeen articles from 16 studies in 9 countries were identified and reviewed. Seven key themes were identified: perceived benefits of non-pharmaceutical interventions, perceived disadvantages of non-pharmaceutical interventions, personal and cultural beliefs about infection transmission, diagnostic uncertainty in emerging respiratory infections, perceived vulnerability to infection, anxiety about emerging respiratory infections and communications about emerging respiratory infections. The synthesis showed that some aspects of non-pharmaceutical respiratory infection control (particularly hand and respiratory hygiene) were viewed as familiar and socially responsible actions to take. There was ambivalence about adopting isolation and personal distancing behaviours in some contexts due to their perceived adverse impact and potential to attract social stigma. Common perceived barriers included beliefs about infection transmission, personal vulnerability to respiratory infection and concerns about self-diagnosis in emerging respiratory infections.
Conclusions
People actively evaluate non-pharmaceutical interventions in terms of their perceived necessity, efficacy, acceptability, and feasibility. To enhance uptake, it will be necessary to address key barriers, such as beliefs about infection transmission, rejection of personal risk of infection and concern about the potential costs and stigma associated with some interventions.
doi:10.1186/1471-2458-14-589
PMCID: PMC4063987  PMID: 24920395
Qualitative; Thematic synthesis; Systematic review; Respiratory infection; Non-pharmaceutical intervention
The British Journal of General Practice  2013;63(611):e378-e385.
Background
Self-monitoring with self-titration of antihypertensives leads to reduced blood pressure. Patients are keen on self-monitoring but little is known about healthcare professional views.
Aim
To explore health professionals‘ views and experiences of patient self-management, particularly with respect to future implementation into routine care.
Design and setting
Qualitative study embedded within a randomised controlled trial of healthcare professionals participating in the TASMINH2 trial of patient self-monitoring with self-titration of antihypertensives from 24 West Midlands general practices.
Method
Taped and transcribed semi-structured interviews with 13 GPs, two practice nurses and one healthcare assistant. Constant comparative method of analysis.
Results
Primary care professionals were positive about self-monitoring, but procedures for ensuring patients measured blood pressure correctly were haphazard. GPs interpreted home readings variably, with many not making adjustment for lower home blood pressure. Interviewees were satisfied with patient training and arrangements for blood pressure monitoring and self-titration of medication during the trial, but less sure about future implementation into routine care. There was evidence of a need for training of both patients and professionals for successful integration of self-management.
Conclusion
Health professionals wanted more patient involvement in hypertension care but needed a framework to work within. Consideration of how to train patients to measure blood pressure and how home readings become part of their care is required before self-monitoring and self-titration can be implemented widely. As home monitoring becomes more widespread, the development of patient self-management, including self-titration of medication, should follow but this may take time to achieve.
doi:10.3399/bjgp13X668168
PMCID: PMC3662454  PMID: 23735408
general practice; hypertension, primary care; qualitative research, self-monitoring
Background
There is a need for cost-effective weight management interventions that primary care can deliver to reduce the morbidity caused by obesity. Automated web-based interventions might provide a solution, but evidence suggests that they may be ineffective without additional human support. The main aim of this study was to carry out a feasibility trial of a web-based weight management intervention in primary care, comparing different levels of nurse support, to determine the optimal combination of web-based and personal support to be tested in a full trial.
Methods
This was an individually randomised four arm parallel non-blinded trial, recruiting obese patients in primary care. Following online registration, patients were randomly allocated by the automated intervention to either usual care, the web-based intervention only, or the web-based intervention with either basic nurse support (3 sessions in 3 months) or regular nurse support (7 sessions in 6 months). The main outcome measure (intended as the primary outcome for the main trial) was weight loss in kg at 12 months. As this was a feasibility trial no statistical analyses were carried out, but we present means, confidence intervals and effect sizes for weight loss in each group, uptake and retention, and completion of intervention components and outcome measures.
Results
All randomised patients were included in the weight loss analyses (using Last Observation Carried Forward). At 12 months mean weight loss was: usual care group (n = 43) 2.44 kg; web-based only group (n = 45) 2.30 kg; basic nurse support group (n = 44) 4.31 kg; regular nurse support group (n = 47) 2.50 kg. Intervention effect sizes compared with usual care were: d = 0.01 web-based; d = 0.34 basic nurse support; d = 0.02 regular nurse support. Two practices deviated from protocol by providing considerable weight management support to their usual care patients.
Conclusions
This study demonstrated the feasibility of delivering a web-based weight management intervention supported by practice nurses in primary care, and suggests that the combination of the web-based intervention with basic nurse support could provide an effective solution to weight management support in a primary care context.
Trial registration
Current Controlled Trials ISRCTN31685626.
doi:10.1186/1479-5868-11-67
PMCID: PMC4045942  PMID: 24886516
Weight reduction programme; Internet; Randomized controlled trial; Obesity; Nurse support
Trials  2014;15:160.
Background
Chronic kidney disease (CKD) is common and increasing in prevalence. Cardiovascular disease (CVD) is a major cause of morbidity and death in CKD, though of a different phenotype to the general CVD population. Few therapies have proved effective in modifying the increased CVD risk or rate of renal decline in CKD. There are accumulating data that aldosterone receptor antagonists (ARA) may offer cardio-protection and delay renal impairment in patients with the CV phenotype in CKD. The use of ARA in CKD has therefore been increasingly advocated. However, no large study of ARA with renal or CVD outcomes is underway.
Methods
The study is a prospective randomised open blinded endpoint (PROBE) trial set in primary care where patients will mainly be identified by their GPs or from existing CKD lists. They will be invited if they have been formally diagnosed with CKD stage 3b or there is evidence of stage 3b CKD from blood results (eGFR 30–44 mL/min/1.73 m2) and fulfil the other inclusion/exclusion criteria. Patients will be randomised to either spironolactone 25 mg once daily in addition to routine care or routine care alone and followed-up for 36 months.
Discussion
BARACK D is a PROBE trial to determine the effect of ARA on mortality and cardiovascular outcomes (onset or progression of CVD) in patients with stage 3b CKD.
Trial registration
EudraCT: 2012-002672-13
ISRTN: ISRCTN44522369
doi:10.1186/1745-6215-15-160
PMCID: PMC4113231  PMID: 24886488
Cardiovascular disease; Chronic kidney disease; CKD mortality; CKD aldosterone receptor antagonist
Background
Recent reviews suggest Web-based interventions are promising approaches for weight management but they identify difficulties with suboptimal usage. The literature suggests that offering some degree of human support to website users may boost usage and outcomes.
Objective
We disseminated the POWeR (“Positive Online Weight Reduction”) Web-based weight management intervention in a community setting. POWeR consisted of weekly online sessions that emphasized self-monitoring, goal-setting, and cognitive/behavioral strategies. Our primary outcome was intervention usage and we investigated whether this was enhanced by the addition of brief telephone coaching. We also explored group differences in short-term self-reported weight loss.
Methods
Participants were recruited using a range of methods including targeted mailouts, advertisements in the local press, notices on organizational websites, and social media. A total of 786 adults were randomized at an individual level through an online procedure to (1) POWeR only (n=264), (2) POWeR plus coaching (n=247), or (3) a waiting list control group (n=275). Those in the POWeR plus coaching arm were contacted at approximately 7 and 28 days after randomization for short coaching telephone calls aimed at promoting continued usage of the website. Website usage was tracked automatically. Weight was assessed by online self-report.
Results
Of the 511 participants allocated to the two intervention groups, the median number of POWeR sessions completed was just one (IQR 0-2 for POWeR only, IQR 0-3 for POWeR plus coach). Nonetheless, a substantial minority completed at least the core three sessions of POWeR: 47 participants (17.8%, 47/264) in the POWeR-only arm and 64 participants (25.9%, 64/247) in the POWeR plus coaching arm. Participants in the POWeR plus coaching group persisted with the intervention for longer and were 1.61 times more likely to complete the core three sessions than the POWeR-only group (χ2 1=4.93; OR 1.61, 95% CI 1.06-2.47; n=511). An intention-to-treat analysis showed between-group differences in weight loss (F 2,782=12.421, P<.001). Both intervention groups reported more weight loss than the waiting list control group. Weight loss was slightly, but not significantly, greater in the POWeR plus coaching group. A large proportion of participants assigned to POWeR plus coaching refused phone calls or were not contactable (57.9%, 143/247). Exploratory analyses identified health and sociodemographic differences between those who did and did not engage in coaching when it was made available to them. Users who engaged with coaching used the intervention more and lost more weight than those who did not.
Conclusions
In common with most Web-based intervention studies, usage of POWeR was suboptimal overall. However, our findings suggest that supplementing Web-based weight management with brief human support could improve usage and outcomes in those who take it up.
Trial Registration
International Standard Randomized Controlled Trial Number (ISRCTN): 98176068; http://www.controlled-trials.com/ISRCTN98176068 (Archived by WebCite at http://www.webcitation.org/6OKRjM2oy).
doi:10.2196/jmir.3199
PMCID: PMC4004138  PMID: 24681761
weight loss; obesity; Internet; adherence; behavioral; randomized controlled trial
Background
Childhood eczema, or childhood atopic dermatitis, causes significant distress to children and their families through sleep disturbance and itch. The main cause of treatment failure is nonuse of prescribed treatments.
Objective
The objective of this study was to develop and test a Web-based intervention to support families of children with eczema, and to explore whether support from a health care professional (HCP) is necessary to engage participants with the intervention.
Methods
We followed the PRECEDE-PROCEED model: regular emollient use was the target behavior we were seeking to promote and we identified potential techniques to influence this. LifeGuide software was used to write the intervention website. Carers of children with eczema were invited through primary care mail-out and randomized to 3 groups: (1) website only, (2) website plus HCP support, or (3) usual care. Patient-Oriented Eczema Measure (POEM) scores were measured online by carer report at baseline and at 12 weeks. Qualitative interviews were carried out with 13 HCPs (primarily practice nurses) and 26 participants to explore their experiences of taking part in the study.
Results
A total of 143 carers were recruited through 31 practices. We found a decrease of ≥2 in follow-up compared with baseline POEM score in 23 of 42 (55%) participants in the website only group, 16 of 49 (33%) in the usual care group, and 18 of 47 (38%) in the website plus HCP group. Website use data showed that 75 of 93 (81%) participants allocated to the website groups completed the core modules, but less than half used other key components (videos: 35%; regular text reminders: 39%). There were no consistent differences in website use between the website only or the website plus HCP groups. Qualitative feedback showed that most HCPs had initial concerns about providing support for eczema self-care because this was not a condition that they felt expert in. However, HCPs reported productive consultations and that they found it helpful to use the website in consultations, while observing that some participants seemed to need more support than others. Qualitative interviews with participants suggested that HCP support was valued highly only by a minority, generally those who were less confident in their management of eczema or less confident using the Internet.
Conclusions
Our pilot trial demonstrated the potential for greater improvements in POEM scores in both website intervention groups and that a full-scale trial is feasible. Such a trial would quantify the effectiveness and cost-effectiveness of this intervention to determine whether it should be widely promoted to families of children with newly diagnosed eczema. In this study population, HCP support was not strongly valued by participants and did not lead to better outcomes or website use than use of the Web-based intervention alone.
Trial Registration
International Standard Randomized Controlled Trial Number (ISRCTN): 98560867; http://www.controlled-trials.com/ISRCTN98560867 (Archived by WebCite at http://www.webcitation.org/6NcxvMtgN).
doi:10.2196/jmir.3035
PMCID: PMC3961807  PMID: 24594972
child; primary care; randomized controlled trial; eczema; Internet; self-care
The British Journal of General Practice  2012;62(605):e801-e807.
Background
Antibiotic use and concomitant resistance are increasing. Literature reviews do not unambiguously indicate which interventions are most effective in improving antibiotic prescribing practice.
Aim
To assess the effectiveness of physician-targeted interventions aiming to improve antibiotic prescribing for respiratory tract infections (RTIs) in primary care, and to identify intervention features mostly contributing to intervention success.
Design and setting
Analysis of a set of physician-targeted interventions in primary care.
Method
A literature search (1990–2009) for studies describing the effectiveness of interventions aiming to optimise antibiotic prescription for RTIs by primary care physicians. Intervention features were extracted and effectiveness sizes were calculated. Association between intervention features and intervention success was analysed in multivariate regression analysis.
Results
This study included 58 studies, describing 87 interventions of which 60% significantly improved antibiotic prescribing; interventions aiming to decrease overall antibiotic prescription were more frequently effective than interventions aiming to increase first choice prescription. On average, antibiotic prescription was reduced by 11.6%, and first choice prescription increased by 9.6%. Multiple interventions containing at least ‘educational material for the physician’ were most often effective. No significant added value was found for interventions containing patient-directed elements. Communication skills training and near-patient testing sorted the largest intervention effects.
Conclusion
This review emphasises the importance of physician education in optimising antibiotic use. Further research should focus on how to provide physicians with the relevant knowledge and tools, and when to supplement education with additional intervention elements. Feasibility should be included in this process.
doi:10.3399/bjgp12X659268
PMCID: PMC3505412  PMID: 23211259
antibiotics; primary health care; education; respiratory tract infection
Background
To reduce the spread of antibiotic resistance, there is a pressing need for worldwide implementation of effective interventions to promote more prudent prescribing of antibiotics for acute LRTI. This study is a process analysis of the GRACE/INTRO trial of a multifactorial intervention that reduced antibiotic prescribing for acute LRTI in six European countries. The aim was to understand how the interventions were implemented and to examine effects of the interventions on general practitioners’ (GPs’) and patients’ attitudes.
Methods
GPs were cluster randomised to one of three intervention groups or a control group. The intervention groups received web-based training in either use of the C-reactive protein (CRP) test, communication skills and use of a patient booklet, or training in both. GP attitudes were measured before and after the intervention using constructs from the Theory of Planned Behaviour and a Website Satisfaction Questionnaire. Effects of the interventions on patients were assessed by a post-intervention questionnaire assessing patient enablement, satisfaction with the consultation, and beliefs about the risks and need for antibiotics.
Results
GPs in all countries and intervention groups had very positive perceptions of the intervention and the web-based training, and felt that taking part had helped them to reduce prescribing. All GPs perceived reducing prescribing as more important and less risky following the intervention, and GPs in the communication groups reported increased confidence to reduce prescribing. Patients in the communication groups who received the booklet reported the highest levels of enablement and satisfaction and had greater awareness that antibiotics could be unnecessary and harmful.
Conclusions
Our findings suggest that the interventions should be broadly acceptable to both GPs and patients, as well as feasible to roll out more widely across Europe. There are also some indications that they could help to engender changes in GP and patient attitudes that will be helpful in the longer-term, such as increased awareness of the potential disadvantages of antibiotics and increased confidence to manage LRTI without them. Given the positive effects of the booklet on patient beliefs and attitudes, it seems logical to extend the use of the patient booklet to all patients.
doi:10.1186/1748-5908-8-134
PMCID: PMC3922910  PMID: 24238118
Prescribing; Antibiotics; Resistance; Questionnaires
The British Journal of General Practice  2012;62(604):e787-e794.
Background
Management of pharyngitis is commonly based on features which are thought to be associated with Lancefield group A beta-haemolytic streptococci (GABHS) but it is debatable which features best predict GABHS. Non-group A strains share major virulence factors with group A, but it is unclear how commonly they present and whether their presentation differs.
Aim
To assess the incidence and clinical variables associated with streptococcal infections.
Design and setting
Prospective diagnostic cohort study in UK primary care.
Method
The presence of pathogenic streptococci from throat swabs was assessed among patients aged ≥5 years presenting with acute sore throat.
Results
Pathogenic streptococci were found in 204/597 patients (34%, 95% CI = 31 to 38%): 33% (68/204) were non-group A streptococci, mostly C (n = 29), G (n = 18) and B (n = 17); rarely D (n = 3) and Streptococcus pneumoniae (n = 1). Patients presented with similar features whether the streptococci were group A or non-group A. The features best predicting A, C or G beta-haemolytic streptococci were patient’s assessment of severity (odds ratio [OR] for a bad sore throat 3.31, 95% CI = 1.24 to 8.83); doctors’ assessment of severity (severely inflamed tonsils OR 2.28, 95% CI = 1.39 to 3.74); absence of a bad cough (OR 2.73, 95% CI = 1.56 to 4.76), absence of a coryza (OR 1.54, 95% CI = 0.99 to 2.41); and moderately bad or worse muscle aches (OR 2.20, 95% CI = 1.41 to 3.42).
Conclusion
Non-group A strains commonly cause streptococcal sore throats, and present with similar symptomatic clinical features to group A streptococci. The best features to predict streptococcal sore throat presenting in primary care deserve revisiting.
doi:10.3399/bjgp12X658322
PMCID: PMC3481520  PMID: 23211183
pharyngitis; primary care; tonsillitis; streptococcus
BMJ Open  2013;3(10):e003943.
Objective
To assess the association between features of acute sore throat and the growth of streptococci from culturing a throat swab.
Design
Diagnostic cohort.
Setting
UK general practices.
Participants
Patients aged 5 or over presenting with an acute sore throat. Patients were recruited for a second cohort (cohort 2, n=517) consecutively after the first (cohort 1, n=606) from similar practices.
Main outcome
Predictors of the presence of Lancefield A/C/G streptococci.
Results
The clinical score developed from cohort 1 had poor discrimination in cohort 2 (bootstrapped estimate of area under the receiver operator characteristic (ROC) curve (0.65), due to the poor validity of the individual items in the second data set. Variables significant in multivariate analysis in both cohorts were rapid attendance (prior duration 3 days or less; multivariate adjusted OR 1.92 cohort, 1.67 cohort 2); fever in the last 24 h (1.69, 2.40); and doctor assessment of severity (severely inflamed pharynx/tonsils (2.28, 2.29)). The absence of coryza or cough and purulent tonsils were significant in univariate analysis in both cohorts and in multivariate analysis in one cohort. A five-item score based on Fever, Purulence, Attend rapidly (3 days or less), severely Inflamed tonsils and No cough or coryza (FeverPAIN) had moderate predictive value (bootstrapped area under the ROC curve 0.73 cohort 1, 0.71 cohort 2) and identified a substantial number of participants at low risk of streptococcal infection (38% in cohort 1, 36% in cohort 2 scored ≤1, associated with a streptococcal percentage of 13% and 18%, respectively). A Centor score of ≤1 identified 23% and 26% of participants with streptococcal percentages of 10% and 28%, respectively.
Conclusions
Items widely used to help identify streptococcal sore throat may not be the most consistent. A modified clinical scoring system (FeverPAIN) which requires further validation may be clinically helpful in identifying individuals who are unlikely to have major pathogenic streptococci.
doi:10.1136/bmjopen-2013-003943
PMCID: PMC3808825  PMID: 24163209
Primary Care
PLoS ONE  2013;8(10):e76691.
Background
Outpatients with acute cough who expect, hope for or ask for antibiotics may be more unwell, benefit more from antibiotic treatment, and be more satisfied with care when they are prescribed antibiotics. Clinicians may not accurately identify those patients.
Objective
To explore whether patient views (expecting, hoping for or asking for antibiotics) are associated with illness presentation and resolution, whether patient views are accurately perceived by clinicians, and the association of all these factors with antibiotic prescribing and patient satisfaction with care.
Methods
Prospective observational study of 3402 adult patients with acute cough presenting in 14 primary care networks. Correlations and associations tested with multilevel logistic regression and McNemar ‘s tests, and Cohen’s Kappa, positive agreement (PA) and negative agreement (NA) calculated as appropriate.
Results
1,213 (45.1%) patients expected, 1,093 (40.6%) hoped for, and 275 (10.2%) asked for antibiotics. Clinicians perceived 840 (31.3%) as wanting to be prescribed antibiotics (McNemar’s test, p<0.05). Their perception agreed modestly with the three patient views (Kappa’s = 0.29, 0.32 and 0.21, PA’s = 0.56, 0.56 and 0.33, NA’s = 0.72, 0.75 and 0.82, respectively). 1,464 (54.4%) patients were prescribed antibiotics. Illness presentation and resolution were similar for patients regardless their views. These associations were not modified by antibiotic treatment. Patient expectation and hope (OR:2.08, 95% CI:[1.48,2.93] and 2.48 [1.73,3.55], respectively), and clinician perception (12.18 [8.31,17.84]) were associated with antibiotic prescribing. 2,354 (92.6%) patients were satisfied. Only those hoping for antibiotics were less satisfied when antibiotics were not prescribed (0.39 [0.17,0.90]).
Conclusion
Patient views about antibiotic treatment were not useful for identifying those who will benefit from antibiotics. Clinician perceptions did not match with patient views, but particularly influenced antibiotic prescribing. Patients were generally satisfied with care, but those hoping for but not prescribed antibiotics were less satisfied. Clinicians need to more effectively elicit and address patient views about antibiotics.
doi:10.1371/journal.pone.0076691
PMCID: PMC3806785  PMID: 24194845
Lancet  2013;382(9899):1175-1182.
Summary
Background
High-volume prescribing of antibiotics in primary care is a major driver of antibiotic resistance. Education of physicians and patients can lower prescribing levels, but it frequently relies on highly trained staff. We assessed whether internet-based training methods could alter prescribing practices in multiple health-care systems.
Methods
After a baseline audit in October to December, 2010, primary-care practices in six European countries were cluster randomised to usual care, training in the use of a C-reactive protein (CRP) test at point of care, in enhanced communication skills, or in both CRP and enhanced communication. Patients were recruited from February to May, 2011. This trial is registered, number ISRCTN99871214.
Results
The baseline audit, done in 259 practices, provided data for 6771 patients with lower-respiratory-tract infections (3742 [55·3%]) and upper-respiratory-tract infections (1416 [20·9%]), of whom 5355 (79·1%) were prescribed antibiotics. After randomisation, 246 practices were included and 4264 patients were recruited. The antibiotic prescribing rate was lower with CRP training than without (33% vs 48%, adjusted risk ratio 0·54, 95% CI 0·42–0·69) and with enhanced-communication training than without (36% vs 45%, 0·69, 0·54–0·87). The combined intervention was associated with the greatest reduction in prescribing rate (CRP risk ratio 0·53, 95% CI 0·36–0·74, p<0·0001; enhanced communication 0·68, 0·50–0·89, p=0·003; combined 0·38, 0·25–0·55, p<0·0001).
Interpretation
Internet training achieved important reductions in antibiotic prescribing for respiratory-tract infections across language and cultural boundaries.
Funding
European Commission Framework Programme 6, National Institute for Health Research, Research Foundation Flanders.
doi:10.1016/S0140-6736(13)60994-0
PMCID: PMC3807804  PMID: 23915885
The British Journal of General Practice  2012;62(602):e639-e646.
Background
Delayed antibiotic prescribing is promoted as a strategy to reduce antibiotic consumption, but its use and its effect on antibiotic consumption in routine care is poorly described.
Aim
To quantify delayed antibiotic prescribing in adults presenting in primary care with acute cough/lower respiratory tract infection (LRTI), duration of advised delay, consumption of delayed antibiotics, and factors associated with consumption.
Design and setting
Prospective observational cohort in general practices in 14 primary care networks in 13 European countries.
Method
GPs recorded clinical features and antibiotic prescribing for adults presenting with an acute infective illness with cough as the dominant symptom. Patients recorded their consumption of antibiotics from any source during the 28-day follow up.
Results
Two hundred and ten (6.3%) of 3368 patients with usable consultation data were prescribed delayed antibiotics. The median recommended delay period was 3 days. Seventy-five (44.4%) of the 169 with consumption data consumed the antibiotic course and a further 18 (10.7%) took another antibiotic during the study period. 50 (29.6%) started their delayed course on the day of prescription. Clinician diagnosis of upper respiratory tract/viral infection and clinician’s perception of patient’s wanting antibiotics were associated with less consumption of the delayed prescription. Patient’s wanting antibiotics was associated with greater consumption.
Conclusion
Delayed antibiotic prescribing was used infrequently for adults presenting in general practice with acute cough/LRTI. When used, the effect on antibiotic consumption was less than found in most trials. There are opportunities for standardising the intervention and promoting wider uptake.
doi:10.3399/bjgp12X654614
PMCID: PMC3426603  PMID: 22947585
anti-bacterial agents; cough; respiratory tract infections; medication adherence; primary health care
The Journal of Infectious Diseases  2013;209(7):1028-1031.
Interferon-inducible transmembrane proteins 1, 2, and 3 (IFITM 1,2, and 3) are viral restriction factors that mediate cellular resistance to several viruses. We have genotyped a possible splice-site altering single-nucleotide polymorphism (rs12252) in the IFITM3 gene in 34 patients with H1N1 influenza and severe pneumonia, and >5000 individuals comprising patients with community-acquired mild lower respiratory tract infection and matched controls of Caucasian ancestry. We found evidence of an association between rs12252 rare allele homozygotes and susceptibility to mild influenza (in patients attending primary care) but could not confirm a previously reported association between this single-nucleotide polymorphism and susceptibility to severe H1N1 infection.
doi:10.1093/infdis/jit468
PMCID: PMC3952664  PMID: 23997235
genetics; H1N1; Influenza; LRTI; infectious disease; IFITM3; association study; Virus
Background
Children with respiratory tract infections are the single most frequent patient group to make use of primary care health care resources. The use of antibiotics remains highly prevalent in young children, but can lead to antimicrobial resistance as well as reinforcing the idea that parents should re-consult for similar symptoms. One of the main drivers of indiscriminate antimicrobial use is the lack of evidence for, and therefore uncertainty regarding, which children are at risk of poor outcome. This paper describes the protocol for the TARGET cohort study, which aims to derive and validate a clinical prediction rule to identify children presenting to primary care with respiratory tract infections who are at risk of hospitalisation.
Methods/design
The TARGET cohort study is a large, multicentre prospective observational study aiming to recruit 8,300 children aged ≥3 months and <16 years presenting to primary care with a cough and respiratory tract infection symptoms from 4 study centres (Bristol, London, Oxford and Southampton). Following informed consent, symptoms, signs and demographics will be measured. In around a quarter of children from the Bristol centre, a single sweep, dual bacterial-viral throat swab will be taken and parents asked to complete a symptom diary until the child is completely well or for 28 days, whichever is sooner. A review of medical notes including clinical history, re-consultation and hospitalisations will be undertaken. Multivariable logistic regression will be used to identify the independent clinical predictors of hospitalisation as well as the prognostic significance of upper respiratory tract microbes. The clinical prediction rule will be internally validated using various methods including bootstrapping.
Discussion
The clinical prediction rule for hospitalisation has the potential to help identify a small group of children for hospitalisation and a much larger group where hospitalisation is very unlikely and antibiotic prescribing would be less warranted. This study will also be the largest natural history study to date of children presenting to primary care with acute cough and respiratory tract infections, and will provide important information on symptom duration, re-consultations and the microbiology of the upper respiratory tract.
doi:10.1186/1472-6963-13-322
PMCID: PMC3765099  PMID: 23958109
Cohort study; Children; Respiratory tract infections (RTIs); Primary care; Protocol; Throat swab

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