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

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; andiii) 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

The appropriateness of prescribing antibiotics in the community in Europe: study design

Contains fulltext : 97417.pdf (publisher's version ) (Open Access)ABSTRACT: BACKGROUND: Over 90% of all antibiotics in Europe are prescribed in primary care. It is important that antibiotics are prescribed that are likely to be effective; however, information about antibiotic resistance in the community is incomplete. The aim of our study is to investigate the appropriateness of antibiotic prescribing in primary care in Europe by collecting and combining patterns of antibiotic resistance patterns and antibiotic prescription patterns in primary care. We will also evaluate the appropriateness of national antibiotic prescription guidelines in relation to resistance patterns. METHODS/DESIGN: Antibiotic resistance will be studied in an opportunistic sample from the community in nine European countries. Resistance data will be collected by taking a nose swab of persons (N = 4,000 per country) visiting a primary care practice for a non-infectious disease. Staphylococcus aureus and Streptococcus pneumoniae will be isolated and tested for resistance to a range of antibiotics in one central laboratory. Data on antibiotic prescriptions over the past 5 years will be extracted from the electronic medical records of General Practitioners (GPs). The results of the study will include the prevalence and resistance data of the two species and 5 years of antibiotic prescription data in nine European countries.The odds of receiving an effective antibiotic in each country will be calculated as a measure for the appropriateness of prescribing. Multilevel analysis will be used to assess the appropriateness of prescribing. Relevant treatment guidelines of the nine participating countries will be evaluated using a standardized instrument and related to the resistance patterns in that country. DISCUSSION: This study will provide valuable and unique data concerning resistance patterns and prescription behaviour in primary care in nine European countries. It will provide evidence-based recommendations for antibiotic treatment guidelines that take resistance patterns into account which will be useful for both clinicians and policy makers. By improving antibiotic use we can move towards controlling the resistance problem globally

Evaluation of a web-based intervention to reduce antibiotic prescribing for LRTI in six European countries: quantitative process analysis of the GRACE/INTRO randomised controlled trial.

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

European Surveillance of Antimicrobial Consumption (ESAC): quality indicators for outpatient antibiotic use in Europe

Background and objective: Indicators to measure the quality of healthcare are increasingly used by healthcare professionals and policy makers. In the context of increasing antimicrobial resistance, this study aimed to develop valid drug-specific quality indicators for outpatient antibiotic use in Europe, derived from European Surveillance of Antimicrobial Consumption (ESAC) data. Methods: 27 experts (15 countries), in a European Science Foundation workshop, built on the expertise within the European Drug Utilisation Research Group, the General Practice Respiratory Infections Network, the ESCMID Study Group on Primary Care Topics, the Belgian Antibiotic Policy Coordination Committee, the World Health Organization, ESAC, and other experts. A set of proposed indicators was developed using 1997–2003 ESAC data. Participants scored the relevance of each indicator to reducing antimicrobial resistance, patient health benefit, cost effectiveness and public health policy makers (scale: 1 (completely disagree) to 9 (completely agree)). The scores were processed according to the UCLA-RAND appropriateness method. Indicators were judged relevant if the median score was not in the 1–6 interval and if there was consensus (number of scores within the 1–3 interval was fewer than one third of the panel). From the relevant indicators providing overlapping information, the one with the highest scores was selected for the final set of quality indicators—values were updated with 2004 ESAC data. Results: 22 participants (12 countries) completed scoring of a set of 22 proposed indicators. Nine were rated as relevant antibiotic prescribing indicators on all four dimensions; five were rated as relevant if only relevance to reducing antimicrobial resistance and public health policy makers was taken into account. A final set of 12 indicators was selected. Conclusion: 12 of the proposed ESAC-based quality indicators for outpatient antibiotic use in Europe have face validity and are potentially applicable. These indicators could be used to better describe antibiotic use in ambulatory care and assess the quality of national antibiotic prescribing patterns in Europe. <br/

General Practitioners' views on the acceptability and applicability of a web-based intervention to reduce antibiotic prescribing for acute cough in multiple European countries: a qualitative study prior to a randomised trial

BACKGROUND: Interventions to promote prudent antibiotic prescribing by general practitioners (GPs) have often only been developed for use in one country. We aimed to develop an intervention which would be appropriate to implement in multiple European countries in order to offer greater benefit to practice whilst using fewer resources. The INTRO (INternet TRaining for antibiOtic use) intervention needed to deliver training to GPs in the use of C-Reactive Protein (CRP) near patient tests to help diagnose acute cough and in communication skills to help explain prescribing decisions to patients. We explored GPs' views on the initial version of INTRO to test acceptability and potentially increase applicability for use in multiple countries before the start of a randomised trial.METHOD: 30 GPs from five countries (Belgium, England, the Netherlands, Poland and Spain), were interviewed using a "think aloud" approach. GPs were asked to work through the intervention and discuss their views on the content and format in relation to following the intervention in their own practice. GPs viewed the same intervention but versions were created in five languages. Data were coded using thematic analysis.RESULTS: GPs in all five countries reported the view that the intervention addressed an important topic, was broadly acceptable and feasible to use, and would be a useful tool to help improve clinical practice. However, GPs in the different countries identified aspects of the intervention that did not reflect their national culture or healthcare system. These included perceived differences in communication style used in the consultation, consultation length and the stage of illness at which patient typically presented.CONCLUSION: An online intervention to support evidence-based use of antibiotics is acceptable and feasible to implement amongst GPs in multiple countries. However, tailoring of the intervention to suit national contexts was necessary by adding local information and placing more emphasis on the fact that GPs could select the communication skills they wished to use in practice. Using think aloud methods to complement the development of interventions is a powerful method to identify regional contextual barriers to intervention implementation

Validity of a clinical model to predict influenza in patients presenting with symptoms of lower respiratory tract infection in primary care

Background. Valid clinical predictors of influenza in patients presenting with lower respiratory tract infection (LRTI) symptoms would provide adequate patient information and reassurance. Aim. Assessing the validity of an existing diagnostic model (Flu Score) to detect influenza in LRTI patients. Design and Setting. A European diagnostic study recruited 1801 adult primary care patients with LRTI-like symptoms existing ≤7 days between October and April 2007–2010. Method. History and physical examination findings were recorded and nasopharyngeal swabs taken. Polymerase chain reaction (PCR) for influenza A/B was performed as reference test. Diagnostic accuracy of the Flu Score (1× onset <48 hours + 2× myalgia + 1× chills or sweats + 2× fever and cough) was expressed as area under the curve (AUC), calibration slopes and likelihood ratios (LRs). Results. A total of 273 patients (15%) had influenza on PCR. The AUC of the Flu Score during winter months was 0.66 [95% CI (95% confidence internal) 0.63–0.70]. During peak influenza season, both influenza prevalence (24%) and AUC were higher [0.71 (95% CI 0.66–0.76], but calibration remained poor. The Flu Score assigned 64% of the patients as ‘low-risk’ (10% had influenza, LR − 0.6). About 12% were classified as ‘high risk’ of whom 32% had influenza (LR + 2.7). During peak influenza season, 60% and 14% of patients were classified as low and high risk, respectively, with influenza prevalences being 14% (LR − 0.5) and 50% (LR + 3.2). Conclusion. The Flu-Score attributes a small subgroup of patients with a high influenza risk (prevalence 32%). However, clinical usefulness is limited because this group is small and the association between predicted and observed risks is poor. Considerable diagnostic imprecision remains when it comes to differentiating those with influenza on clinical grounds from the many other causes of LRTI in primary care. New point of care tests are required that accurately, rapidly and cost effectively detect influenza in patients with respiratory tract symptoms in primary care

Antibiotic prescribing for discoloured sputum in acute cough/LRTI

We investigated whether discoloured sputum and feeling unwell is associated with antibiotic prescribing and benefit from antibiotic treatment for acute cough/lower respiratory tract infection in a prospective study of 3402 adults. in 13 countries. A two-level model investigated the association between producing discoloured sputum or feeling generally unwell and an antibiotic prescription. A three-level model investigated the association between an antibiotic prescription and symptom resolution. Patients producing discoloured sputum were prescribed antibiotics more frequently than those not producing sputum (OR: 3.2, 95% CI: [2.1, 5.0]), unlike those producing clear/white sputum (OR: 0.95, 95% CI: [0.61,1.48]). Antibiotic prescribing was not associated with greater rate or magnitude of symptoms score resolution (as measured by 13 item scale completed by patients each day) among those who: produced yellow (Coefficient: 0.00, p-value: 0.68) or green sputum (Coefficient: ?0.01, p-value: 0.11); reported any of three categories of feeling unwell; produced discoloured sputum and felt generally unwell (Coefficient: ?0.01, p-value: 0.19). Adults with acute cough/LRTI presenting in primary care with discoloured sputum were prescribed antibiotics more often compared to those not producing sputum. Sputum colour, alone or together with feeling generally unwell was not associated with recovery or benefit from antibiotic treatment.<br/