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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.  Activity Increase Despite Arthritis (AÏDA): design of a Phase II randomised controlled trial evaluating an active management booklet for hip and knee osteoarthritis [ISRCTN24554946] 
BMC Family Practice  2009;10:62.
Background
Hip and knee osteoarthritis is a common cause of pain and disability, which can be improved by exercise interventions. However, regular exercise is uncommon in this group because the low physical activity level in the general population is probably reduced even further by pain related fear of movement. The best method of encouraging increased activity in this patient group is not known. A booklet has been developed for patients with hip or knee osteoarthritis. It focuses on changing disadvantageous beliefs and encouraging increased physical activity.
Methods/Design
This paper describes the design of a Phase II randomised controlled trial (RCT) to test the effectiveness of this new booklet for patients with hip and knee osteoarthritis in influencing illness and treatment beliefs, and to assess the feasibility of conducting a larger definitive RCT in terms of health status and exercise behaviour. A computerised search of four general medical practice patients' record databases will identify patients older than 50 years of age who have consulted with hip or knee pain in the previous twelve months. A random sample of 120 will be invited to participate in the RCT comparing the new booklet with a control booklet, and we expect 100 to return final questionnaires. This trial will assess the feasibility of recruitment and randomisation, the suitability of the control intervention and outcome measurement tools, and will provide an estimate of effect size. Outcomes will include beliefs about hip and knee pain, beliefs about exercise, fear avoidance, level of physical activity, health status and health service costs. They will be measured at baseline, one month and three months.
Discussion
We discuss the merits of testing effectiveness in a phase II trial, in terms of intermediate outcome measures, whilst testing the processes for a larger definitive trial. We also discuss the advantages and disadvantages of testing the psychometric properties of the primary outcome measures concurrently with the trial.
Trial registration
Current Controlled Trials ISRCTN24554946
doi:10.1186/1471-2296-10-62
PMCID: PMC2744666  PMID: 19732415
3.  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
4.  Determining patient and primary care delay in the diagnosis of cancer – lessons from a pilot study of patients referred for suspected cancer 
Background
There is no validated way of measuring diagnostic delay in cancer, especially covering patient and primary care delays. An instrument is needed in order to determine the effect of potential interventions to reduce delay and improve cancer morbidity and mortality.
Methods
Development of a postal questionnaire tool to measure patient and primary care time responses to key symptoms and signs. The pilot questionnaire was sent to 184 patients with suspected cancer.
Results
The response rate was only 85/184 (46.2%). Anxiety was cited as one reason for this low response. Patients returning questionnaires were more likely to be women and more likely to be younger. 84/85 (98.8%) provided consent to access medical records, and questions regarding health profile, smoking and socio-economic profile were answered adequately. Outcome data on their cancer diagnosis was linked satisfactorily and the question about GP-initiated investigations was answered well. Estimated dates for symptom duration were preferred for patient delays, but exact dates were preferred for primary care delays; however there was a significant amount of missing data.
Conclusion
A more personal approach to the collection of data about the duration of symptoms in this group of people is needed other than a postal questionnaire. However elements of this piloted questionnaire are likely to figure strongly in future development and evaluation of this tool.
doi:10.1186/1471-2296-9-9
PMCID: PMC2259302  PMID: 18234092
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

Results 1-5 (5)