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1.  Building an international network for a primary care research program: reflections on challenges and solutions in the set-up and delivery of a prospective observational study of acute cough in 13 European countries 
BMC Family Practice  2011;12:78.
Background
Implementing a primary care clinical research study in several countries can make it possible to recruit sufficient patients in a short period of time that allows important clinical questions to be answered. Large multi-country studies in primary care are unusual and are typically associated with challenges requiring innovative solutions. We conducted a multi-country study and through this paper, we share reflections on the challenges we faced and some of the solutions we developed with a special focus on the study set up, structure and development of Primary Care Networks (PCNs).
Method
GRACE-01 was a multi-European country, investigator-driven prospective observational study implemented by 14 Primary Care Networks (PCNs) within 13 European Countries. General Practitioners (GPs) recruited consecutive patients with an acute cough. GPs completed a case report form (CRF) and the patient completed a daily symptom diary. After study completion, the coordinating team discussed the phases of the study and identified challenges and solutions that they considered might be interesting and helpful to researchers setting up a comparable study.
Results
The main challenges fell within three domains as follows:
i) selecting, setting up and maintaining PCNs;
ii) designing local context-appropriate data collection tools and efficient data management systems; and
iii) gaining commitment and trust from all involved and maintaining enthusiasm.
The main solutions for each domain were:
i) appointing key individuals (National Network Facilitator and Coordinator) with clearly defined tasks, involving PCNs early in the development of study materials and procedures.
ii) rigorous back translations of all study materials and the use of information systems to closely monitor each PCNs progress;
iii) providing strong central leadership with high level commitment to the value of the study, frequent multi-method communication, establishing a coherent ethos, celebrating achievements, incorporating social events and prizes within meetings, and providing a framework for exploitation of local data.
Conclusions
Many challenges associated with multi-country primary care research can be overcome by engendering strong, effective communication, commitment and involvement of all local researchers. The practical solutions identified and the lessons learned in implementing the GRACE-01 study may assist in establishing other international primary care clinical research platforms.
Trial registration
ClinicalTrials.gov Identifier: NCT00353951
doi:10.1186/1471-2296-12-78
PMCID: PMC3176157  PMID: 21794112
2.  Enhancing the quality of antibiotic prescribing in Primary Care: Qualitative evaluation of a blended learning intervention 
BMC Family Practice  2010;11:34.
Background
The Stemming the Tide of Antibiotic Resistance (STAR) Educational Program aims to enhance the quality of antibiotic prescribing and raise awareness about antibiotic resistance among general medical practitioners. It consists of a seven part, theory-based blended learning program that includes online reflection on clinicians' own practice, presentation of research evidence and guidelines, a practice-based seminar focusing on participants' own antibiotic prescribing and resistance rates in urine samples sent from their practice, communication skills training using videos of simulated patients in routine surgeries, and participation in a web forum. Effectiveness was evaluated in a randomised controlled trial in which 244 GPs and Nurse Practitioners and 68 general practices participated. This paper reports part of the process evaluation of that trial.
Methods
Semi-structured, digitally recorded, and transcribed telephone interviews with 31 purposively sampled trial participants analysed using thematic content analysis.
Results
The majority of participants reported increased awareness of antibiotic resistance, greater self-confidence in reducing antibiotic prescribing and at least some change in consultation style and antibiotic prescribing behaviour. Reported practical changes included adopting a practice-wide policy of antibiotic prescription reduction. Many GPs also reported increased insight into patients' expectations, ultimately contributing to improved doctor-patient rapport. The components of the intervention put forward as having the greatest influence on changing clinician behaviour were the up-to-date research evidence resources, simple and effective communication skills presented in on-line videos, and presentation of the practice's own antibiotic prescribing levels combined with an overview of local resistance data.
Conclusion
Participants regarded this complex blended learning intervention acceptable and feasible, and reported wide-ranging, positive changes in attitudes and clinical practice as a result of participating in the STAR Educational Program.
Trial registration
Current Controlled Trials ISRCTN63355948
doi:10.1186/1471-2296-11-34
PMCID: PMC2881907  PMID: 20459655
3.  Stemming the Tide of Antibiotic Resistance (STAR): A protocol for a trial of a complex intervention addressing the 'why' and 'how' of appropriate antibiotic prescribing in general practice 
BMC Family Practice  2009;10:20.
Background
After some years of a downward trend, antibiotic prescribing rates in the community have tended to level out in many countries. There is also wide variation in antibiotic prescribing between general practices, and between countries. There are still considerable further gains that could be made in reducing inappropriate antibiotic prescribing, but complex interventions are required. Studies to date have generally evaluated the effect of interventions on antibiotic prescribing in a single consultation and pragmatic evaluations that assess maintenance of new skills are rare. This paper describes the protocol for a pragmatic, randomized evaluation of a complex intervention aimed at reducing antibiotic prescribing by primary care clinicians.
Methods and design
We developed a Social Learning Theory based, blended learning program (on-line learning, a practice based seminar, and context bound learning) called the STAR Educational Program. The 'why of change' is addressed by providing clinicians in general practice with information on antibiotic resistance in urine samples submitted by their practice and their antibiotic prescribing data, and facilitating a practice-based seminar on the implications of this data. The 'how of change' is addressed through context-bound communication skills training and information on antibiotic indication and choice. This intervention will be evaluated in a trial involving 60 general practices, with general practice as the unit of randomization (clinicians from each practice to either receive the STAR Educational Program or not) and analysis. The primary outcome will be the number of antibiotic items dispensed over one year. An economic and process evaluation will also be conducted.
Discussion
This trial will be the first to evaluate the effectiveness of this type of theory-based, blended learning intervention aimed at reducing antibiotic prescribing by primary care clinicians. Novel aspects include feedback of practice level data on antimicrobial resistance and prescribing, use of principles from motivational interviewing, training in enhanced communication skills that incorporates context-bound experience and reflection, and using antibiotic dispensing over one year (as opposed to antibiotic prescribing in a single consultation) as the main outcome.
Trial registration
Current Controlled Trials ISRCTN63355948.
doi:10.1186/1471-2296-10-20
PMCID: PMC2666645  PMID: 19309493
4.  The effect of using an interactive booklet on childhood respiratory tract infections in consultations: Study protocol for a cluster randomised controlled trial in primary care 
BMC Family Practice  2008;9:23.
Background
Respiratory tract infections in children result in more primary care consultations than any other acute condition, and are the most common reason for prescribing antibiotics (which are largely unnecessary). About a fifth of children consult again for the same illness episode. Providing parents with written information on respiratory tract infections may result in a reduction in re-consultation rates and antibiotic prescribing for these illnesses. Asking clinicians to provide and discuss the information during the consultation may enhance effectiveness. This paper outlines the protocol for a study designed to evaluate the use of a booklet on respiratory tract infections in children within primary care consultations.
Methods/Design
This will be a cluster randomised controlled trial. General practices will be randomised to provide parents consulting because their child has an acute respiratory tract infection with either an interactive booklet, or usual care. The booklet provides information on the expected duration of their child's illness, the likely benefits of various treatment options, signs and symptoms that should prompt re-consultation, and symptomatic treatment advice. It has been designed for use within the consultation and aims to enhance communication through the use of specific prompts. Clinicians randomised to using the interactive booklet will receive online training in its use. Outcomes will be assessed via a telephone interview with the parent two weeks after first consulting. The primary outcome will be the proportion of children who re-consult for the same illness episode. Secondary outcomes include: antibiotic use, parental satisfaction and enablement, and illness costs. Consultation rates for respiratory tract infections for the subsequent year will be assessed by a review of practice notes.
Discussion
Previous studies in adults and children have shown that educational interventions can result in reductions in re-consultation rates and use of antibiotics for respiratory tract infections. This will be the first study to determine whether providing parents with a booklet on respiratory tract infections in children, and discussing it with them during the consultation, reduces re-consultations and antibiotic use for the same illness without reducing satisfaction with care.
Trial registration
Current Controlled Trials ISRCTN46104365
doi:10.1186/1471-2296-9-23
PMCID: PMC2383910  PMID: 18435857
5.  Improving management of patients with acute cough by C-reactive protein point of care testing and communication training (IMPAC3T): study protocol of a cluster randomised controlled trial 
BMC Family Practice  2007;8:15.
Background
Most antibiotic prescriptions for acute cough due to lower respiratory tract infections (LRTI) in primary care are not warranted. Diagnostic uncertainty and patient expectations and worries are major drivers of unnecessary antibiotic prescribing. A C-reactive protein (CRP) point of care test may help GPs to better guide antibiotic treatment by ruling out pneumonia in cases of low test results. Alternatively, enhanced communication skills training to help clinicians address patients' expectations and worries could lead to a decrease in antibiotic prescribing, without compromising clinical recovery, while enhancing patient enablement. The aim of this paper is to describe the design and methods of a study to assess two interventions for improving LRTI management in general practice.
Methods/Design
This cluster randomised controlled, factorial trial will introduce two interventions in general practice; point of care CRP testing and enhanced communication skills training for LRTI. Twenty general practices with two participating GPs per practice will recruit 400 patients with LRTI during two winter periods. Patients will be followed up for at least 28 days. The primary outcome measure is the antibiotic prescribing rate. Secondary outcomes are clinical recovery, cost-effectiveness, use of other diagnostic tests and medical services (including reconsultation), and patient enablement.
Discussion
This trial is the first cluster randomised trial to evaluate the influence of point of care CRP testing in the hands of the general practitioner and enhanced communication skills, on the management of LRTI in primary care. The pragmatic nature of the study, which leaves treatment decisions up to the responsible clinicians, will enhance the applicability and generalisability of findings. The factorial design will allow conclusion to be made about the value of CRP testing on its own, communication skills training on its own, and the two combined. Evaluating a biomedical and communication based intervention ('hard' and 'soft' technologies) together in this way makes this trial unique in its field.
doi:10.1186/1471-2296-8-15
PMCID: PMC1847819  PMID: 17394651

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