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1.  Setting up a clinical trial in care homes: challenges encountered and recommendations for future research practice 
BMC Research Notes  2015;8:306.
Older adults in care homes have increasingly complex health care needs, and care provision should be evidence-based whenever possible. However, recruitment of frail, older people to research is a complex process and often results in care home residents being excluded from research participation. This paper draws on the experience of setting up a randomised controlled trial to determine the effectiveness of probiotics on antibiotic-associated diarrhoea in care home residents [Probiotics for Antibiotic Associated Diarrhoea in Care Homes (PAAD) Study] in Wales.
Significant challenges were encountered setting up a clinical trial in care homes. There were a number of barriers and facilitative factors encountered that were unique to this research setting. The classification of the study intervention (a widely available food supplement with a low risk safety profile) as an investigational medicinal product, with the associated requirements including obtaining statutory approvals and research governance, had a major impact.
The process for setting up a clinical trial of an investigational medicinal product in care homes has been more complex and time consuming than the process for setting up an observational study in the same setting, and clinical trials in other health care settings. We recommend regulatory changes to ensure approvals processes are more proportionate to risk and context, to ensure that care home residents have the opportunity to participate in research and are able to help generate much needed evidence to underpin care. Recommendations made may inform future research practice.
Trial registration: ISRCTN 25324586.
PMCID: PMC4504165  PMID: 26179284
Care homes; Older people; Clinical trial; Recruitment; Ethics; Low-risk intervention
2.  The influence of children’s day care on antibiotic seeking: a mixed methods study 
The British Journal of General Practice  2014;64(622):e302-e312.
Preschool-aged children are the highest consumers of antibiotics, but consult mainly for viral infections. Little is known about how day care, which is common in this age group, influences primary care consulting and treatment-seeking behaviours.
To investigate daycare providers’ approaches to excluding and/or readmitting children with infections, and the consequences for parents’ consulting and antibiotic-seeking behaviours.
Design and setting
Cross-sectional survey, document analysis, and qualitative interviews of daycare providers and parents in South East Wales, UK.
A total of 328 daycare providers were asked to complete a survey about infection exclusion practices and to provide a copy of their sickness exclusion policy. Next, 52 semi-structured interviews were conducted with purposively selected questionnaire responders and parents using their services. Questionnaire responses underwent bivariate analysis, policies underwent document analysis, and interviews were thematically analysed using constant comparison methods.
In total 217 out of 328 (66%) daycare providers responded; 82 out of 199 (41%) reported advising parents that their child may need antibiotics and 199 out of 214 (93%) reported advising general practice consultations. Interviews confirmed that such advice was routine, and beliefs about antibiotic indications often went against clinical guidelines: 24% (n = 136) of sickness exclusion policies mentioning infections made at least one non-evidence-based indication for ‘treatment’ or antibiotics. Parent interviews revealed that negotiating daycare requirements lowered thresholds for consulting and encouraged antibiotic seeking.
Daycare providers encourage parents to consult general practice and seek antibiotics through non-evidence-based policies and practices. Parents’ perceptions of daycare providers’ requirements override their own beliefs of when it is appropriate to consult and seek treatment.
PMCID: PMC4001146  PMID: 24771845
antibiotics; children; day care; general practice; infection; qualitative
3.  Adherence-adjusted estimates of benefits and harms from treatment with amoxicillin for LRTI: secondary analysis of a 12-country randomised placebo-controlled trial using randomisation-based efficacy estimators 
BMJ Open  2015;5(3):e006160.
Estimate the efficacy of amoxicillin for acute uncomplicated lower-respiratory-tract infection (LRTI) in primary care and demonstrate the use of randomisation-based efficacy estimators.
Secondary analysis of a two-arm individually-randomised placebo-controlled trial.
Primary care practices in 12 European countries.
Patients aged 18 or older consulting with an acute LRTI in whom pneumonia was not suspected by the clinician.
Amoxicillin (two 500 mg tablets three times a day for 7 days) or matched placebo.
Main outcome measures
Clinician-rated symptom severity between days 2–4; new/worsening symptoms and presence of side effects at 4-weeks. Adherence was captured using self-report and tablet counts.
2061 participants were randomised to the amoxicillin or placebo group. On average, 88% of the prescribed amoxicillin was taken. The original analysis demonstrated small increases in both benefits and harms from amoxicillin. Minor improvements in the benefits of amoxicillin were observed when an adjustments for adherence were made (mean difference in symptom severity −0.08, 95% CI −0.17 to 0.01, OR for new/worsening symptoms 0.81, 95% CI 0.66 to 0.98) as well as minor increases in harms (OR for side effects 1.32, 95% CI 1.12 to 1.57).
Adherence to amoxicillin was high, and the findings from the original analysis were robust to non-adherence. Participants consulting to primary care with an acute uncomplicated LRTI can on average expect minor improvements in outcome from taking amoxicillin. However, they are also at an increased risk of experiencing side effects.
Trial registration numbers
Eudract-CT 2007-001586-15 and ISRCTN52261229.
The trial was registered at EudraCT in 2007 due to an administrative misunderstanding that EudraCT was a suitable registry—which it was not in 2007, but has become since. On discovery of this error, the trial was also registered at ISRCTN (January 2009). Trial procedures did not change between the two registrations.
PMCID: PMC4360594  PMID: 25748415
4.  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;15:187.
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.
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.
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).
PMCID: PMC4251943  PMID: 25425162
Urinary Tract Infection; Primary care; Adult women; Point-of-care-test; Near-patient testing; Antibiotic resistance; Cost effectiveness
5.  Public Beliefs on Antibiotics and Symptoms of Respiratory Tract Infections among Rural and Urban Population in Poland: A Questionnaire Study 
PLoS ONE  2014;9(10):e109248.
General public views and expectations around the use of antibiotics can influence general practitioners' antibiotic prescribing decisions. We set out to describe the knowledge, attitudes and beliefs about the use of antibiotics for respiratory tract infections in adults in Poland, and explore differences according to where people live in an urban-rural continuum.
Material and Methods
Face to face survey among a stratified random sample of adults from the general population.
1,210 adults completed the questionnaire (87% response rate); 44.3% were rural; 57.9% were women. 49.4% of rural respondents and 44.4% of urban respondents had used an antibiotic in the last 2 years. Rural participants were less likely to agree with the statement “usually I know when I need an antibiotic,” (53.5% vs. 61.3% respectively; p = 0.015) and reported that they would consult with a physician for a cough with yellow/green phlegm (69.2% vs. 74.9% respectively; p = 0.004), and were more likely to state that they would leave the decision about antibiotic prescribing to their doctor (87.5% vs. 85.6% respectively; p = 0.026). However, rural participants were more likely to believe that antibiotics accelerate recovery from sore throat (45.7% vs. 37.1% respectively; p = 0.017). Use of antibiotic in the last 2 years, level of education, number of children and awareness of the problem of developing antimicrobial resistance predicted accurate knowledge about antibiotic effectiveness.
There were no major differences in beliefs about antibiotics between urban and rural responders, although rural responders were slightly less confident in their knowledge about antibiotics and self-reported greater use of antibiotics. Despite differences in the level of education between rural and urban responders, there were no significant differences in their knowledge about antibiotic effectiveness.
PMCID: PMC4183578  PMID: 25275516
6.  Exploring patients’ views of primary care consultations with contrasting interventions for acute cough: a six-country European qualitative study 
In a pan-European randomised controlled trial (GRACE INTRO) of two interventions, (i) a point-of-care C-reactive protein test and/or (ii) training in communication skills and use of an interactive patient booklet, both interventions resulted in large reductions in antibiotic prescribing for acute cough.
This process evaluation explored patients’ views of primary care consultations using the two interventions in six European countries.
Sixty-two interviews were conducted with patients who had participated in the GRACE INTRO trial. Interviews were transcribed verbatim and translated into English where necessary. Analysis used techniques from thematic and framework analysis.
Most patients were satisfied with their consultation despite many not receiving an antibiotic. Patients appeared to accept the use of both intervention approaches. A minority, but particularly in the trial arm with both interventions, reported that they would wait longer before consulting for cough in future.
Patients perceived that both interventions supported the general practitioner’s (GP’s) prescribing decisions by helping them understand when an antibiotic was, and was not, needed. Patients consulting with acute cough had largely positive views about the GP’s enhanced communication skills, which included understanding their concerns, and the use of a near-patient test as an additional investigation.
PMCID: PMC4373386  PMID: 25030621
7.  Cost-effectiveness of point-of-care C-reactive protein testing to inform antibiotic prescribing decisions 
The British Journal of General Practice  2013;63(612):e465-e471.
Point-of-care C-reactive protein (POCCRP) is a biomarker of inflammation that offers clinicians a rapid POC test to guide antibiotic prescribing decisions for acute cough and lower respiratory tract infections (LRTI). However, evidence that POCCRP is cost-effective is limited, particularly outside experimental settings.
To assess the cost-effectiveness of POCCRP as a diagnostic tool for acute cough and LRTI from the perspective of the health service.
Design and setting
Observational study of the presentation, management, and outcomes of patients with acute cough and LRTI in primary care settings in Norway and Sweden.
Using hierarchical regression, data were analysed in terms of the effect on antibiotic use, cost, and patient outcomes (symptom severity after 7 and 14 days, time to recovery, and EQ-5D), while controlling for patient characteristics (self-reported symptom severity, comorbidities, and health-related quality of life) at first attendance.
POCCRP testing is associated with non-significant positive reductions in antibiotic prescribing (P = 0.078) and increased cost (P = 0.092). Despite the uncertainty, POCCRP testing is also associated with a cost per quality-adjusted life year (QALY) gain of €9391. At a willingness-to-pay threshold of €30 000 per QALY gained, there is a 70% probability of CRP being cost-effective.
POCCRP testing is likely to provide a cost-effective diagnostic intervention both in terms of reducing antibiotic prescribing and in terms of QALYs gained.
PMCID: PMC3693803  PMID: 23834883
antibiotics; cost-effectiveness; C-reactive protein; primary health care; respiratory tract infections
8.  General practitioners’ perceptions of introducing near-patient testing for common infections into routine primary care: A qualitative study 
Near-patient tests are promoted for guiding management of common infections in primary care with a view to enhancing the effectiveness of prescribing decisions and containing antimicrobial resistance. Changes in clinical practice should be based on appraisals of the factors that might influence change, viewed from the perspective of those expected to implement the change. We therefore explored the views of general practitioners concerning the possible introduction of near-patient tests for managing common infections.
Qualitative semi-structured interview study. Interviews were recorded and analysed using thematic content analysis.
General practices in south-east Wales, UK.
A total of 26 general practitioners (GPs) from high fluroquinolone antibiotics prescribing practices and 14 GPs from practices that prescribed fluroquinolones close to the south-east Wales mean.
There was strong enthusiasm for a hypothetical near-patient, finger-prick blood tests that could distinguish viral from bacterial infections. Many GPs emphasized that such tests would be valuable in “selling” decisions not to prescribe antibiotics to patients. Concerns included limited additional useful information to guide prescribing above clinical diagnosis alone, that patients might deteriorate even if the tests correctly identified a viral aetiology, and that GPs would need to be convinced by research evidence supporting uptake. Several indicated that tests would be useful only for a limited number of patients and they were concerned by time pressures, apparatus maintenance and quality control, cost, and possible objections from patients, especially children.
Despite GP enthusiasm for the concept of a rapid test to distinguish viral from bacterial infection, strategies to promote uptake would be enhanced if concerns were addressed regarding the importance and feasibility of such tests in daily practice.
PMCID: PMC3406622  PMID: 18297558
Antibiotics; family practice; near-patient tests; physician views; point of care tests; primary care; qualitative research
9.  Antibiotic-resistant infections in primary care are symptomatic for longer and increase workload: outcomes for patients with E.coli UTIs 
Antimicrobial resistance is considered to be one of the major threats to public health. However, the practical implications for patients and workload in primary care are largely unknown.
To determine outcomes for patients managed in primary care with an antibiotic resistant compared to an antibiotic sensitive Escherichia coli (E. coli) urinary tract infection (UTI).
Nested case control study with prospective measurement of outcomes.
Ten general practices in South Wales.
Patients consulting with symptoms suggestive of UTI identified through systematic sampling, and with a laboratory proven E. coli infection, were followed up by interview 1 month after their consultations and by searching of their medical records.
Nine hundred and thirty-two patients were interviewed and had their medical records reviewed. The risk of patients reporting ‘feeling poorly’, ‘frequency or pain on urinating’ and being ‘out of action’ for more than 5 days after consulting was significantly increased for patients with resistant compared to sensitive infections. After adjusting for risk factors, there was an increased risk of ‘frequency or pain on urinating’ and ‘being out of action’ for those infected with a resistant E. coli. The median number of maximum reported days with at least one symptom was 12 days for patients with E. coli infections resistant to trimethoprim, 7 days for infections resistant to ampicillin, 7 days for infections resistant to any antibiotic, and 5 days for infections sensitive to all tested antibiotics. Even if treated with an appropriate antibiotic, infections caused by a resistant strain were symptomatic for longer. For those infected with an organism resistant to at least one antibiotic, the odds ratio (OR) for re-visiting their GP within the next 30 days for the UTI was 1.47 (95% confidence interval [CI] = 1.10 to 1.95). The OR was 1.49 (95% CI = 1.11 to 2.00) for ampicillin resistance and 2.48 (95% CI = 1.70 to 3.59) for trimethoprim resistance.
Resistant E. coli UTIs are symptomatic for longer and cause increased work load in general practice.
PMCID: PMC1876635  PMID: 16954001
anti-bacterial agents; cohort study; drug resistance, bacterial; primary health care; treatment outcomes; urinary tract infections
10.  Nutrition economic evaluation of a probiotic in the prevention of antibiotic-associated diarrhea 
Introduction: Antibiotic-associated diarrhea (AAD) is common and frequently more severe in hospitalized elderly adults. It can lead to increased use of healthcare resources. We estimated the cost-effectiveness of a fermented milk (FM) with probiotic in preventing AAD and in particular Clostridium difficile-associated diarrhea (CDAD).
Methods: Clinical effectiveness data and cost information were incorporated in a model to estimate the cost impact of administering a FM containing the probiotic Lactobacillus paracasei ssp paracasei CNCM I-1518 in a hospital setting. Preventing AAD by the consumption of the probiotic was compared to no preventive strategy.
Results: The probiotic intervention to prevent AAD generated estimated mean cost savings of £339 per hospitalized patient over the age of 65 years and treated with antibiotics, compared to no preventive probiotic. Estimated cost savings were sensitive to variation in the incidence of AAD, and to the proportion of patients who develop non-severe/severe AAD. However, probiotics remained cost saving in all sensitivity analyses.
Conclusion: Use of the fermented dairy drink containing the probiotic L. paracasei CNCM I-1518 to prevent AAD in older hospitalized patients treated with antibiotics could lead to substantial cost savings.
PMCID: PMC3926519  PMID: 24596556
antibiotic-associated diarrhea; Clostridium difficile; hospitalized elderly; probiotics; cost effectiveness; nutrition economics
11.  Prevalence of urinary tract infection in acutely unwell children in general practice: a prospective study with systematic urine sampling 
The British Journal of General Practice  2013;63(607):e156-e164.
Urinary tract infection (UTI) in children may be associated with long-term complications that could be prevented by prompt treatment.
To determine the prevalence of UTI in acutely ill children ≤ 5 years presenting in general practice and to explore patterns of presenting symptoms and urine sampling strategies.
Design and setting
Prospective observational study with systematic urine sampling, in general practices in Wales, UK.
In total, 1003 children were recruited from 13 general practices between March 2008 and July 2010. The prevalence of UTI was determined and multivariable analysis performed to determine the probability of UTI.
Out of 597 (60.0%) children who provided urine samples within 2 days, the prevalence of UTI was 5.9% (95% confidence interval [CI] = 4.3% to 8.0%) overall, 7.3% in those < 3 years and 3.2% in 3–5 year olds. Neither a history of fever nor the absence of an alternative source of infection was associated with UTI (P = 0.64; P = 0.69, respectively). The probability of UTI in children aged ≥3 years without increased urinary frequency or dysuria was 2%. The probability of UTI was ≥5% in all other groups. Urine sampling based purely on GP suspicion would have missed 80% of UTIs, while a sampling strategy based on current guidelines would have missed 50%.
Approximately 6% of acutely unwell children presenting to UK general practice met the criteria for a laboratory diagnosis of UTI. This higher than previously recognised prior probability of UTI warrants raised awareness of the condition and suggests clinicians should lower their threshold for urine sampling in young children. The absence of fever or presence of an alternative source of infection, as emphasised in current guidelines, may not rule out UTI in young children with adequate certainty.
PMCID: PMC3553642  PMID: 23561695
children; general practice; prevalence; symptoms; urinary tract infections
12.  Parents’ and clinicians’ views of an interactive booklet about respiratory tract infections in children: a qualitative process evaluation of the EQUIP randomised controlled trial 
BMC Family Practice  2013;14:182.
‘When should I worry?’ is an interactive booklet for parents of children presenting with respiratory tract infections (RTIs) in primary care and associated training for clinicians. A randomised controlled trial (the EQUIP study) demonstrated that this intervention reduced antibiotic prescribing and future consulting intentions. The aims of this qualitative process evaluation were to understand how acceptable the intervention was to clinicians and parents, how it was implemented, the mechanisms for any observed effects, and contextual factors that could have influenced its effects.
Semi-structured interviews were conducted with 20 parents and 13 clinicians who participated in the trial. Interviews were audio-recorded and transcribed verbatim. Data were analysed using a framework approach, which involved five stages; familiarisation, development of a thematic framework, indexing, charting, and interpretation.
Most parents and clinicians reported that the ‘When should I worry’ interactive booklet (and online training for clinicians) was easy to use and valuable. Information on recognising signs of serious illness and the usual duration of illness were most valued. The interactive use of the booklet during consultations was considered to be important, but this did not always happen. Clinicians reported lack of time, lack of familiarity with using the booklet, and difficulty in modifying their treatment plan/style of consultation as barriers to use. Increased knowledge and confidence amongst clinicians and patients were seen as key components that contributed to the reductions in antibiotic prescribing and intention to consult seen in the trial. This was particularly pertinent in a context where decisions about the safe and appropriate management of childhood RTIs were viewed as complex and parents reported frequently receiving inconsistent messages.
The ‘When should I worry’ booklet, which is effective in reducing antibiotic prescribing, has high acceptability for clinicians and parents, helps address gaps in knowledge, increases confidence, and provides a consistent message. However, it is not always implemented as intended. Plans for wider implementation of the intervention in health care settings would need to address clinician-related barriers to implementation.
Trial registration
PMCID: PMC4219394  PMID: 24289324
Respiratory tract infections; Child; Antibiotic; Consulting; Qualitative; Process evaluation
14.  Communicating about expected course and re-consultation for respiratory tract infections in children: an exploratory study 
Acute respiratory tract infection is the commonest reason for children consulting, and about one-fifth re-consult for the same illness episode. Fifty-nine audiotape recordings from nine general practitioners (GPs) consulting with children with acute respiratory tract infections were examined. Prognosis was mentioned in only 22 consultations, with GPs predicting a brief course in 11, a possibly longer than expected course in six, and with predicted duration not made explicit in five. Carers were invited to re-consult if they were ‘unhappy’ with the child's condition in 11 consultations, and specific triggers to re-consult were provided in 15. A patient information leaflet was given out only once. Providing carers with an evidence-based account of the likely clinical course and communicating specific triggers to re-consult may help them manage more of these illness episodes without re-consulting.
PMCID: PMC1324807  PMID: 15239917
children; infections, upper respiratory; physician–patient relations; prognosis; patient education
15.  Are Patient Views about Antibiotics Related to Clinician Perceptions, Management and Outcome? A Multi-Country Study in Outpatients with Acute Cough 
PLoS ONE  2013;8(10):e76691.
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.
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.
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.
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]).
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.
PMCID: PMC3806785  PMID: 24194845
16.  Delayed antibiotic prescribing and associated antibiotic consumption in adults with acute cough 
The British Journal of General Practice  2012;62(602):e639-e646.
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.
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.
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.
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.
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.
PMCID: PMC3426603  PMID: 22947585
anti-bacterial agents; cough; respiratory tract infections; medication adherence; primary health care
17.  IFITM3 and Susceptibility to Respiratory Viral Infections in the Community 
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.
PMCID: PMC3952664  PMID: 23997235
genetics; H1N1; Influenza; LRTI; infectious disease; IFITM3; association study; Virus
18.  Consent, including advanced consent, of older adults to research in care homes: a qualitative study of stakeholders’ views in South Wales 
Trials  2013;14:247.
Care home residents, especially those lacking capacity to provide consent for themselves, are frequently excluded from research, thus limiting generalisability of study findings. We set out to explore stakeholders’ views about the ethical and practical challenges associated with recruiting care home residents into research studies.
Qualitative individual interviews with care home residents (n = 14), their relatives (n = 14), and general practitioners (GPs) (n = 10), and focus groups (n = 2) with care home staff. Interviews focused on the issues of older adults consenting to research in care homes, including advanced consent, in general and through reference to a particular study on the use of probiotics to prevent Antibiotic Associated Diarrhoea. Data were analysed using a thematic approach incorporating themes that had been identified in advance, and themes derived from the data. Researchers discussed evidence for themes, and reached consensus on the final themes.
Respondents were generally accepting of low risk observational studies and slightly less accepting of low risk randomised trials of medicinal products. Although respondents identified some practical barriers to informed consent, consenting arrangements were considered workable. Residents and relatives varied in the amount of detail they wanted included in information sheets and consent discussions, but were generally satisfied that an advanced consent model was acceptable and appropriate. Opinions differed about what should happen should residents lose capacity during a research study.
Research staff should be mindful of research guidance and ensure that they have obtained an appropriate level of informed consent without overwhelming the participant with unnecessary detail. For research involving medicinal products, research staff should also be more explicit when recruiting that consent is still valid should an older person lose capacity during a trial provided the individual did not previously state a wish to be withdrawn if they lose capacity, and provided they do not indicate objection or resistance after loss of capacity.
PMCID: PMC3750808  PMID: 23937972
Consent; Older adults; Qualitative research; Mental capacity; Ethics; Recruitment; Common infections
19.  ‘The Body Gets Used to Them’: Patients’ Interpretations of Antibiotic Resistance and the Implications for Containment Strategies 
Interventions promoting evidence based antibiotic prescribing and use frequently build on the concept of antibiotic resistance but patients and clinicians may not share the same assumptions about its meaning.
To explore patients’ interpretations of ‘antibiotic resistance’ and to consider the implications for strategies to contain antibiotic resistance.
Multi country qualitative interview study.
One hundred and twenty-one adult patients from primary care research networks based in nine European countries who had recently consulted a primary care clinician with symptoms of Lower Respiratory Tract Infection (LRTI).
Semi-structured interviews with patients following their consultation and subjected to a five-stage analytic framework approach (familiarization, developing a thematic framework from the interview questions and the themes emerging from the data, indexing, charting, and mapping to search for interpretations in the data), with local network facilitators commenting on preliminary reports.
The dominant theme was antibiotic resistance as a property of a ‘resistant human body’, where the barrier to antibiotic effectiveness was individual loss of responsiveness. Less commonly, patients correctly conceptualized antibiotic resistance as a property of bacteria. Nevertheless, the over-use of antibiotics was a strong central concept in almost all patients’ explanations, whether they viewed resistance as located in either the body or in bacteria.
Most patients were aware of the link between antibiotic use and antibiotic resistance. The identification of the misinterpretation of antibiotic resistance as a property of the human body rather than bacterial cells could inform clearer clinician–patient discussions and public health interventions through emphasising the transferability of resistance, and the societal contribution individuals can make through more appropriate antibiotic prescribing and use.
PMCID: PMC3378752  PMID: 22065334
antibiotic resistance; primary health care; qualitative research; patient beliefs
20.  Antibiotics for acute cough: an international observational study of patient adherence in primary care 
The British Journal of General Practice  2012;62(599):e429-e437.
Non-adherence to acute antibiotic prescriptions is poorly described and may impact on clinical outcomes, healthcare costs, and interpretation of research. It also results in leftover antibiotics that could be used inappropriately.
To describe adherence to antibiotics prescribed for adults presenting with acute cough in primary care, factors associated with non-adherence, and associated recovery.
Design and setting
Prospective observational cohort study in general practices in 14 European primary care networks.
GPs recorded patient characteristics and prescribing decisions for adults with acute cough or clinical presentation suggestive of lower respiratory tract infection. Patients recorded antibiotic consumption and daily symptoms over 28 days. Rates of adherence to prescribed antibiotics were assessed, and factors associated with non-adherence were identified using logistic regression. Recovery was compared using a Cox proportional hazards model.
Of 2520 patients prescribed immediate or no antibiotics at the index consultation, 282 (11.2%) took an antibiotic during the follow-up period that was not prescribed for them at the index consultation. Of these, 38.1% had no reconsultations during this period. Prior duration of symptoms, antibiotic treatment duration, antibiotic choice, and primary care network were all associated with adherence. There was no difference in time to recovery between those who were prescribed antibiotics at the index consultation and were fully adherent, partially adherent, and non-adherent.
Non-adherence to antibiotics for acute cough or lower respiratory tract infection is common. Duration of treatment, choice of antibiotic, and setting were associated with adherence but adherence to treatment was not associated with differences in recovery.
PMCID: PMC3361123  PMID: 22687236
anti-bacterial agents; cough; general practice; medication adherence; respiratory tract infections.
21.  Counselling patients about behaviour change: the challenge of talking about diet 
As obesity levels increase, opportunistic behaviour change counselling from primary care clinicians in consultations about healthy eating is ever more important. However, little is known about the approaches clinicians take with patients.
To describe the content of simulated consultations on healthy eating in primary care, and compare this with the content of smoking cessation consultations.
Design and setting
Qualitative study of 23 audiotaped simulated healthy eating and smoking cessation consultations between an actor and primary care clinicians (GPs and nurses) within a randomised controlled trial looking at behaviour change counselling.
Consultations were audiotaped and transcribed verbatim, then analysed inductively using thematic analysis. A thematic framework was developed by all authors and applied to the data. The content of healthy eating consultations was contrasted with that given for smoking cessation.
There was a lack of consistency and clarity when clinicians discussed healthy eating compared with smoking; in smoking cessation consultations, the content was clearer to both the clinician and patient. There was a lack of specificity about what dietary changes should be made, how changes could be achieved, and how progress could be monitored. Barriers to change were addressed in more depth within the smoking cessation consultations than within the healthy eating encounters.
At present, dietary counselling by clinicians in primary care does not typically contain consistent, clear suggestions for specific change, how these could be achieved, and how progress would be monitored. This may contribute to limited uptake and efficacy of dietary counselling in primary care.
PMCID: PMC3252535  PMID: 22520664
communication, behaviour change counselling; commnication; healthy eating; primary care
22.  Carers’ perspectives on the presentation of community-acquired pneumonia and empyema in children: a case series 
BMJ Open  2012;2(5):e001500.
To describe carers’ perceptions of the development and presentation of community-acquired pneumonia or empyema in their children.
Case series.
Seven hospitals with paediatric inpatient units in South Wales, UK.
Carers of 79 children aged 6 months to 16 years assessed in hospital between October 2008 and September 2009 with radiographic, community-acquired pneumonia or empyema.
Carers were recruited in hospital and participated in a structured face-to-face or telephone interview about the history and presenting features of their children's illnesses. Responses to open questions were initially coded very finely and then grouped into common themes. Cases were classified into two age groups: 3 or more years and under 3 years.
The reported median duration of illness from onset until the index hospital presentation was 4 days (IQR 2–9 days). Pain in the torso was reported in 84% of cases aged 3 or more years and was the most common cause for carer concern in this age group. According to carer accounts, clinicians sometimes misjudged the origin of this pain. Almost all carers reported something unusual about the index illness that had particularly concerned them—mostly non-specific physical symptoms and behavioural changes.
Pain in the torso and carer concerns about unusual symptoms in their child may provide valuable additional information in a clinician's assessment of the risk of pneumonia in primary care. Further research is needed to confirm the diagnostic value of these features.
PMCID: PMC3437434  PMID: 22952163
Tropical Medicine; Epidemiology; Paediatrics; Paediatric thoracic medicine; Thoracic Medicine; Respiratory infections; Paediatric palliative care; Paediatric infectious disease & immunisation
23.  Understanding variation in primary medical care: a nine-country qualitative study of clinicians’ accounts of the non-clinical factors that shape antibiotic prescribing decisions for lower respiratory tract infection 
BMJ Open  2012;2(4):e000796.
There is a wide variation between European countries in antibiotic prescribing for patients in primary care with lower respiratory tract infection (LRTI) that is not explained by case mix and clinical factors alone. Variation in antibiotic prescribing that is not warranted by differences in illness and clinical presentation may increase selection of resistant organisms, contributing to the problem of antibiotic resistance. This study aimed to investigate clinicians’ accounts of non-clinical factors that influence their antibiotic prescribing decision for patients with LRTI, to understand variation and identify opportunities for addressing possible unhelpful variation.
Multicountry qualitative semistructured interview study, with data subjected to a five-stage analytic framework approach (familiarisation, developing a thematic framework from interview questions and emerging themes, indexing, charting and interpretation), and with interviewers commenting on preliminary analytic themes.
Primary care.
Eighty primary care clinicians randomly selected from primary care research networks based in nine European cities.
Clinicians’ accounts identified non-clinical factors imposed by the healthcare system operating within specific regional primary care research networks, including patient access to antibiotics before consulting a doctor (Barcelona and Milan), systems to reduce patient expectations for antibiotics (Southampton and Antwerp) and lack of consistent treatment guidelines (Balatonfüred and Łódź). Secondly, accounts revealed factors related to specific characteristics of clinicians regardless of network (professional ethos, self-belief in decision-making and commitment to shared decision-making).
Addressing healthcare system factors (eg, limiting patients’ self-management with antibiotics before consulting in primary care, increased public awareness and provision of more consistent guidelines) may assist in reducing unhelpful variation in antibiotic prescribing. Promoting clinicians’ receptivity to change, confidence in decision-making and readiness to invest in explaining prescribing decisions may also be beneficial. As factors were emphasised differently between networks, local flexibility in interventions is likely to maximise effectiveness.
PMCID: PMC4401816  PMID: 22918670
Primary Care; Thoracic Medicine; Respiratory infections; Qualitative Research
24.  The diagnosis of urinary tract infections in young children (DUTY): protocol for a diagnostic and prospective observational study to derive and validate a clinical algorithm for the diagnosis of UTI in children presenting to primary care with an acute illness 
BMC Infectious Diseases  2012;12:158.
Urinary tract infection (UTI) is common in children, and may cause serious illness and recurrent symptoms. However, obtaining a urine sample from young children in primary care is challenging and not feasible for large numbers. Evidence regarding the predictive value of symptoms, signs and urinalysis for UTI in young children is urgently needed to help primary care clinicians better identify children who should be investigated for UTI. This paper describes the protocol for the Diagnosis of Urinary Tract infection in Young children (DUTY) study. The overall study aim is to derive and validate a cost-effective clinical algorithm for the diagnosis of UTI in children presenting to primary care acutely unwell.
DUTY is a multicentre, diagnostic and prospective observational study aiming to recruit at least 7,000 children aged before their fifth birthday, being assessed in primary care for any acute, non-traumatic, illness of ≤ 28 days duration. Urine samples will be obtained from eligible consented children, and data collected on medical history and presenting symptoms and signs. Urine samples will be dipstick tested in general practice and sent for microbiological analysis. All children with culture positive urines and a random sample of children with urine culture results in other, non-positive categories will be followed up to record symptom duration and healthcare resource use. A diagnostic algorithm will be constructed and validated and an economic evaluation conducted.
The primary outcome will be a validated diagnostic algorithm using a reference standard of a pure/predominant growth of at least >103, but usually >105 CFU/mL of one, but no more than two uropathogens.
We will use logistic regression to identify the clinical predictors (i.e. demographic, medical history, presenting signs and symptoms and urine dipstick analysis results) most strongly associated with a positive urine culture result. We will then use economic evaluation to compare the cost effectiveness of the candidate prediction rules.
This study will provide novel, clinically important information on the diagnostic features of childhood UTI and the cost effectiveness of a validated prediction rule, to help primary care clinicians improve the efficiency of their diagnostic strategy for UTI in young children.
PMCID: PMC3575241  PMID: 22812651
Urinary Tract Infection; Children; Primary care; Point-of-care-test; Dipstick test; Near-patient testing; Diagnosis; Economic models
25.  Clinical influences on antibiotic prescribing decisions for lower respiratory tract infection: a nine country qualitative study of variation in care 
BMJ Open  2012;2(3):e000795.
There is variation in antibiotic prescribing for lower respiratory tract infections (LRTI) in primary care that does not benefit patients. This study aims to investigate clinicians' accounts of clinical influences on antibiotic prescribing decisions for LRTI to better understand variation and identify opportunities for improvement.
Multi country qualitative interview study. Semi-structured interviews using open-ended questions and a patient scenario. Data were subjected to five-stage analytic framework approach (familiarisation, developing a thematic framework from the interview questions and emerging themes, indexing, charting and mapping to search for interpretations), with interviewers commenting on preliminary reports.
Primary care.
80 primary care clinicians randomly selected from primary care research networks based in nine European cities.
Clinicians reported four main individual clinical factors that guided their antibiotic prescribing decision: auscultation, fever, discoloured sputum and breathlessness. These were considered alongside a general impression of the patient derived from building a picture of the illness course, using intuition and familiarity with the patient. Comorbidity and older age were considered main risk factors for poor outcomes. Clinical factors were similar across networks, apart from C reactive protein near patient testing in Tromsø. Clinicians developed ways to handle diagnostic and management uncertainty through their own clinical routines.
Clinicians emphasised the importance of auscultation, fever, discoloured sputum and breathlessness, general impression of the illness course, familiarity with the patient, comorbidity, and age in informing their antibiotic prescribing decisions for LRTI. As some of these factors may be overemphasised given the evolving evidence base, greater standardisation of assessment and integration of findings may help reduce unhelpful variation in management. Non-clinical influences will also need to be addressed.
Article summary
Article focus
Clinicians' accounts of clinical influences on antibiotic prescribing decisions for LRTI.
Understand variation and identify opportunities for improvement.
Key messages
Clinicians reported four main clinical factors that guided their antibiotic prescribing decision: auscultation findings, fever, discoloured sputum and breathlessness. Clinical factors were similar across networks, apart from C reactive protein near patient testing used in Tromsø.
These clinical factors were considered alongside a general impression of the patient derived from consideration of illness course, intuition and familiarity with the patient.
Clinicians developed ways to handle diagnostic and management uncertainty through their own clinical routines.
Strengths and limitations of this study
This is the first study to use semi-structured qualitative interviews to capture clinicians' views about LRTI management across a broad range of contrasting European countries.
The clinicians who participated were affiliated to a research network so may not have been representative of all general practitioners in their country.
Qualitative interviews gather reports of behaviour and attitude rather than actual behaviour, but by allowing clinicians to introduce and elaborate on themes spontaneously, we were able to gain an impression of the themes that held most prominence to the clinicians themselves.
PMCID: PMC3364454  PMID: 22619265

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