Development and validation of a risk prediction model for hospital admission in COVID-19 patients presenting to primary care.

BACKGROUND: There is a paucity of prognostic models for COVID-19 that are usable for in-office patient assessment in general practice (GP). OBJECTIVES: To develop and validate a risk prediction model for hospital admission with readily available predictors. METHODS: A retrospective cohort study linking GP records from 8 COVID-19 centres and 55 general practices in the Netherlands to hospital admission records. The development cohort spanned March to June 2020, the validation cohort March to June 2021. The primary outcome was hospital admission within 14 days. We used geographic leave-region-out cross-validation in the development cohort and temporal validation in the validation cohort. RESULTS: In the development cohort, 4,806 adult patients with COVID-19 consulted their GP (median age 56, 56% female); in the validation cohort 830 patients did (median age 56, 52% female). In the development and validation cohort respectively, 292 (6.1%) and 126 (15.2%) were admitted to the hospital within 14 days, respectively. A logistic regression model based on sex, smoking, symptoms, vital signs and comorbidities predicted hospital admission with a c-index of 0.84 (95% CI 0.83 to 0.86) at geographic cross-validation and 0.79 (95% CI 0.74 to 0.83) at temporal validation, and was reasonably well calibrated (intercept -0.08, 95% CI -0.98 to 0.52, slope 0.89, 95% CI 0.71 to 1.07 at geographic cross-validation and intercept 0.02, 95% CI -0.21 to 0.24, slope 0.82, 95% CI 0.64 to 1.00 at temporal validation). CONCLUSION: We derived a risk model using readily available variables at GP assessment to predict hospital admission for COVID-19. It performed accurately across regions and waves. Further validation on cohorts with acquired immunity and newer SARS-CoV-2 variants is recommended.

A general practice prediction model based on signs and symptoms of COVID-19 patients reliably predicted hospitalisation.The model performed well in second-wave data with other dominant variants and changed testing and vaccination policies.In an emerging pandemic, GP data can be leveraged to develop prognostic models for decision support and to predict hospitalisation rates.

Potential impact of a new sepsis prediction model for the primary care setting: early health economic evaluation using an observational cohort.

OBJECTIVES: To estimate the potential referral rate and cost impact at different cut-off points of a recently developed sepsis prediction model for general practitioners (GPs). DESIGN: Prospective observational study with decision tree modelling. SETTING: Four out-of-hours GP services in the Netherlands. PARTICIPANTS: 357 acutely ill adult patients assessed during home visits. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome is the cost per patient from a healthcare perspective in four scenarios based on different cut-off points for referral of the sepsis prediction model. Second, the number of hospital referrals for the different scenarios is estimated. The potential impact of referral of patients with sepsis on mortality and hospital admission was estimated by an expert panel. Using these study data, a decision tree with a time horizon of 1 month was built to estimate the referral rate and cost impact in case the model would be implemented. RESULTS: Referral rates at a low cut-off (score 2 or 3 on a scale from 0 to 6) of the prediction model were higher than observed for patients with sepsis (99% and 91%, respectively, compared with 88% observed). However, referral was also substantially higher for patients who did not need hospital assessment. As a consequence, cost-savings due to referral of patients with sepsis were offset by increased costs due to unnecessary referral for all cut-offs of the prediction model. CONCLUSIONS: Guidance for referral of adult patients with suspected sepsis in the primary care setting using any cut-off point of the sepsis prediction model is not likely to save costs. The model should only be incorporated in sepsis guidelines for GPs if improvement of care can be demonstrated in an implementation study. TRIAL REGISTRATION NUMBER: Dutch Trial Register (NTR 7026).

Antibiotic consumption and time to recovery from uncomplicated urinary tract infection: secondary analysis of observational data from a point-of-care test trial.

BACKGROUND: Randomised trials provide high-quality evidence on the effects of prescribing antibiotics for urinary tract infection (UTI) but may not reflect the effects in those who consume antibiotics. Moreover, they mostly compare different antibiotic types or regimens but rarely include a 'no antibiotic' group. AIM: To estimate the effect of antibiotic consumption, rather than prescription, on time to recovery in females with uncomplicated UTI. DESIGN AND SETTING: Secondary analysis of 14-day observational data from a point-of-care test trial for UTI in primary care in England, the Netherlands, Spain, and Wales, which ran from 2012 to 2014. Clinicians treated patients using their own judgement, providing immediate, delayed, or no antibiotic. METHOD: UTI-symptomatic females who either consumed or did not consume antibiotics during a 14-day follow-up were included. Antibiotic consumption was standardised across participants and grouped into either ≤3 or >3 standardised antibiotic days. To account for confounders, a robust propensity score matching analysis was conducted. Adjusted Kaplan-Meier and Cox proportional hazard models were employed to estimate time to recovery and hazard ratios, respectively. RESULTS: A total of n = 333 females who consumed antibiotics and n = 80 females who did not consume antibiotics were identified and included in the study. The adjusted median time to recovery was 2 days longer among patients who did not consume antibiotics (9 days, 95% confidence interval [CI] = 7 to 12) compared with those who did (7 days, 95% CI = 7 to 8). No difference was found between those who consumed ≤3 (7 days, 95% CI = 7 to 8) compared with >3 standardised antibiotic days (7 days, 95% CI = 6 to 9). CONCLUSION: Consuming antibiotics was associated with a reduction in self-reported time to recovery, but more antibiotics exposure was not associated with faster recovery in this study.

The accuracy and feasibility of respiratory rate measurements in acutely ill adult patients by GPs: a mixed-methods study.

BACKGROUND: Tachypnoea in acutely ill patients can be an early sign of a life-threatening condition such as sepsis. Routine measurement of the respiratory rate by GPs might improve the recognition of sepsis. AIM: To assess the accuracy and feasibility of respiratory rate measurements by GPs. DESIGN & SETTING: Observational cross-sectional mixed-methods study in the setting of out-of-hours (OOH) home visits at three GP cooperatives in The Netherlands. METHOD: GPs were observed during the assessment of acutely ill patients, and semi-structured interviews were performed. The GP-assessed respiratory rate was compared with a reference measurement. In the event that the respiratory rate was not counted, GPs were asked to estimate the rate (dichotomised as ≥22 breaths per minute or <22 breaths per minute). RESULTS: Observations of 130 acutely ill patients were included, and 14 GPs were interviewed. In 33 patients (25%), the GP counted the respiratory rate. A mean difference of 0.27 breaths per minute (95% confidence interval [CI] = -5.7 to 6.3) with the reference measurement was found. At a cut-off point of ≥22 breaths per minute, a sensitivity of 86% (95% CI = 57% to 98%) was found when the GP counted the rate, and a sensitivity of 43% (95% CI = 22% to 66%) when GPs estimated respiratory rates. GPs reported both medical and practical reasons for not routinely measuring the respiratory rate. CONCLUSION: GPs are aware of the importance of assessing the respiratory rate of acutely ill adult patients, and counted measurements are accurate. However, in most patients the respiratory rate was not counted, and the rate was often underestimated when estimated.

New clinical prediction model for early recognition of sepsis in adult primary care patients: a prospective diagnostic cohort study of development and external validation.

BACKGROUND: Recognising patients who need immediate hospital treatment for sepsis while simultaneously limiting unnecessary referrals is challenging for GPs. AIM: To develop and validate a sepsis prediction model for adult patients in primary care. DESIGN AND SETTING: This was a prospective cohort study in four out-of-hours primary care services in the Netherlands, conducted between June 2018 and March 2020. METHOD: Adult patients who were acutely ill and received home visits were included. A total of nine clinical variables were selected as candidate predictors, next to the biomarkers C-reactive protein, procalcitonin, and lactate. The primary endpoint was sepsis within 72 hours of inclusion, as established by an expert panel. Multivariable logistic regression with backwards selection was used to design an optimal model with continuous clinical variables. The added value of the biomarkers was evaluated. Subsequently, a simple model using single cut-off points of continuous variables was developed and externally validated in two emergency department populations. RESULTS: A total of 357 patients were included with a median age of 80 years (interquartile range 71-86), of which 151 (42%) were diagnosed with sepsis. A model based on a simple count of one point for each of six variables (aged >65 years; temperature >38°C; systolic blood pressure ≤110 mmHg; heart rate >110/min; saturation ≤95%; and altered mental status) had good discrimination and calibration (C-statistic of 0.80 [95% confidence interval = 0.75 to 0.84]; Brier score 0.175). Biomarkers did not improve the performance of the model and were therefore not included. The model was robust during external validation. CONCLUSION: Based on this study's GP out-of-hours population, a simple model can accurately predict sepsis in acutely ill adult patients using readily available clinical parameters.

Diagnostic performance of the Idylla™ respiratory panel for molecular detection of influenza A/B in patients presenting to primary care with influenza-like illness during 3 consecutive influenza seasons.

BACKGROUND: Influenza virus (IFV) is often encountered in primary care. Implementation of a rapid diagnostic test for its detection at the point-of-care would enable discrimination from other viral causes of influenza-like-illness (ILI) and might be helpful in individual patient management. In this study, the diagnostic performance of such a point-of-care platform was evaluated. METHODS: Respiratory samples (n = 1490) from ILI-patients in primary care in 15 European countries were collected as part of a prospective clinical trial. Both children (n = 252) and adults (n = 1238) were sampled during 3 consecutive periods of high IFV endemicity. Samples were analysed in a central laboratory, after storage at -70 °C, with the Idylla™ Respiratory Panel, detecting both IFV and RSV, on the Idylla™ platform. The Fast Track Diagnostics (FTD) Respiratory Pathogens 21 plus assay was used as reference. A subset of samples (n = 192) was analysed both fresh and after being frozen. RESULTS: The reference method detected IFV-A in 42% and IFV-B in 13% of the samples. Sensitivity of the Idylla for detection of IFV-A and IFV-B was 98.2% and 92.3% and specificity 97.7% and 98.4% respectively. False negative samples contained significantly lower viral loads than true positive samples (FTD mean Ct-value 30.7 versus 26.1 for IFV-A and 30.4 versus 25.1 for IFV-B, p < 0.001). Comparable results were obtained for Idylla analysis using fresh and frozen samples. CONCLUSIONS: The Idylla Respiratory Panel is a promising point-of-care test for detection of IFV in ILI patients due to its excellent diagnostic performance, minimal training requirements and limited hands-on time.

Transformation of primary care during the COVID-19 pandemic: experiences of healthcare professionals in eight European countries.

BACKGROUND: Primary care has a crucial role in responding to the COVID-19 pandemic as the first point of patient care and gatekeeper to secondary care. Qualitative studies exploring the experiences of healthcare professionals during the COVID-19 pandemic have mainly focused on secondary care. AIM: To gain an understanding of the experiences of European primary care professionals (PCPs) working during the first peak of the COVID-19 pandemic. DESIGN AND SETTING: An exploratory qualitative study, using semi-structured interviews in primary care in England, Belgium, the Netherlands, Ireland, Germany, Poland, Greece, and Sweden, between April and July 2020. METHOD: Interviews were audiorecorded, transcribed, and analysed using a combination of inductive and deductive thematic analysis techniques. RESULTS: Eighty interviews were conducted with PCPs. PCPs had to make their own decisions on how to rapidly transform services in relation to COVID-19 and non-COVID-19 care. Despite being overwhelmed with guidance, they often lacked access to practical training. Consequently, PCPs turned to their colleagues for moral support and information to try to quickly adjust to new ways of working, including remote care, and to deal with uncertainty. CONCLUSION: PCPs rapidly transformed primary care delivery despite a number of challenges. Representation of primary care at policy level and engagement with local primary care champions are needed to facilitate easy and coordinated access to practical information on how to adapt services, ongoing training, and access to appropriate mental health support services for PCPs. Preservation of autonomy and responsiveness of primary care are critical to preserve the ability for rapid transformation in any future crisis of care delivery.

C-reactive protein point-of-care testing in children with cough: qualitative study of GPs' perceptions.

BACKGROUND: Point-of-care C-reactive protein (CRP) testing is widely accepted in Dutch general practice for adult patients with acute cough, but GPs' perceptions of its use in children with suspected lower respiratory tract infection (LRTI) are unknown. Knowledge of these perceptions is important when considering broadening its indication to use in children. AIM: To explore the perceptions of Dutch GPs of the addition of point-of-care CRP testing to the diagnostic evaluation of children, and compare these to their perceptions of use in adults. DESIGN & SETTING: A qualitative study in general practice in the Netherlands. METHOD: Semi-structured interviews were held with 11 GPs. Interviews were analysed using open coding and a thematic approach. RESULTS: GPs' perceptions of the addition of point-of-care CRP testing to diagnostic process in children with suspected LRTI differ from their perceptions of this in adults. Five themes were identified: patient characteristics; vulnerability of the child; clinical presentation; availability of evidence; the impact of the procedure; and use of point-of-care CRP testing as a communication tool. CONCLUSION: Differences between the perceptions of using point-of-care CRP testing in children and adults need to be addressed when considering the possible implementation of this diagnostic instrument.

Parents' attitudes and views regarding antibiotics in the management of respiratory tract infections in children: a qualitative study of the influence of an information booklet.

BACKGROUND: Respiratory tract infection (RTI) is the most common reason to consult a GP during childhood, and often results in unnecessary prescribing of antibiotics. Using an information booklet during the consultation has been shown to be a promising tool to reduce antibiotic prescribing. The influence of such information on parents' views, knowledge, and expectations has not been investigated yet. AIM: To explore the reported attitude and knowledge of parents towards antibiotics and management of childhood RTI, as well as the added influence of an information booklet, as perceived by parents. DESIGN & SETTING: Qualitative interviews were conducted with Dutch parents who consulted the GP with their child for RTI symptoms and received an information booklet. METHOD: Semi-structured interviews were audio-recorded, transcribed, coded, and analysed using framework analysis by open-axial coding and describing themes. RESULTS: Eighteen parents were interviewed. Four themes were identified: prior reticence towards antibiotics; expectations of the consultation and trust in the GPs' treatment decision; confirmation and reassurance by the booklet; self-management and future consultation intentions. Dutch parents felt reassured and more confident about their pre-existing reticent attitude towards antibiotic treatment; therefore, they thought their opinion and attitude had not really been changed by the booklet. CONCLUSION: In a low-prescribing country like the Netherlands, information should focus on enhancing self-efficacy and providing concrete safety-netting advice. For other countries with less reticence towards antibiotics, it is recommended that the knowledge, attitude, and perceptions of the population is studied, in order to be able to tailor interventions.

Point-of-care C-reactive protein to assist in primary care management of children with suspected non-serious lower respiratory tract infection: a randomised controlled trial.

BACKGROUND: Overprescription of antibiotics for lower respiratory tract infections (LRTIs) in children is common, partly due to diagnostic uncertainty, in which case the addition of point-of-care (POC) C-reactive protein (CRP) testing can be of aid. AIM: To assess whether use of POC CRP by the GP reduces antibiotic prescriptions in children with suspected non-serious LRTI. DESIGN & SETTING: An open, pragmatic, randomised controlled trial in daytime general practice and out-of-hours services. METHOD: Children between 3 months and 12 years of age with acute cough and fever were included and randomised to either use of POC CRP or usual care. Antibiotic prescription rates were measured and compared between groups using generalising estimating equations. RESULTS: There was no statistically significant reduction in antibiotic prescriptions in the GP use of CRP group (30.9% versus 39.4%; odds ratio [OR] 0.6; 95% confidence interval [CI] = 0.29 to 1.23). Only the estimated severity of illness was related to antibiotic prescription. Forty-six per cent of children had POC CRP levels <10mg/L. CONCLUSION: It is still uncertain whether POC CRP measurement in children with non-serious respiratory tract infection presenting to general practice can reduce the prescription of antibiotics. Until new research provides further evidence, POC CRP measurement in these children is not recommended.

Clinical relevance of bacterial resistance in lower respiratory tract infection in primary care: secondary analysis of a multicentre European trial.

BACKGROUND: The impact of antimicrobial resistance on clinical outcomes in patients with lower respiratory tract infection in primary care is largely unknown. AIM: To determine the illness course of infections with resistant bacteria in adults presenting to primary care with acute cough. DESIGN AND SETTING: Secondary analysis of a multicentre European trial in primary care. METHOD: A total of 2061 adults with acute cough (lasting ≤28 days) were recruited from primary care and randomised to amoxicillin or placebo. To reflect the natural course of disease, only patients in the placebo group (n = 1021) were eligible. Nasopharyngeal flocked swabs and/or sputa (when available) were analysed at baseline and Streptococcus pneumoniae and Haemophilus influenzae isolates underwent susceptibility testing. Patients recorded their symptoms in a diary every day for 4 weeks. Patients with and without resistant bacterial infection were compared with regards to symptom severity, duration of symptoms, worsening of illness, and duration of interference with normal activities or work. RESULTS: Of the 834 patients with diary records, 104 showed S. pneumoniae and/or H. influenzae infection. Of this number, 54 (52%) were resistant to antibiotics, while seven (7%) were resistant to penicillin. For the duration of symptoms rated 'moderately bad or worse' (hazard ratio 1.27, 95% confidence interval [CI] = 0.67 to 2.44), mean symptom severity (difference -0.48, 95% CI = -1.17 to 0.21), and worsening of illness (odds ratio 0.31, 95% CI = 0.07 to 1.41), there was no statistically significant difference between the antibiotic-resistant and antibiotic-sensitive groups. CONCLUSION: The illness course of antibiotic-resistant lower respiratory tract infection does not differ from that caused by antibiotic-sensitive bacteria.

Development of a prediction tool for patients presenting with acute cough in primary care: a prognostic study spanning six European countries.

BACKGROUND: Accurate prediction of the course of an acute cough episode could curb antibiotic overprescribing, but is still a major challenge in primary care. AIM: The authors set out to develop a new prediction rule for poor outcome (re-consultation with new or worsened symptoms, or hospital admission) in adults presenting to primary care with acute cough. DESIGN AND SETTING: Data were collected from 2604 adults presenting to primary care with acute cough or symptoms suggestive of lower respiratory tract infection (LRTI) within the Genomics to combat Resistance against Antibiotics in Community-acquired LRTI in Europe (GRACE; www.grace-lrti.org) Network of Excellence. METHOD: Important signs and symptoms for the new prediction rule were found by combining random forest and logistic regression modelling. Performance to predict poor outcome in acute cough patients was compared with that of existing prediction rules, using the models' area under the receiver operator characteristic curve (AUC), and any improvement obtained by including additional test results (C-reactive protein [CRP], blood urea nitrogen [BUN], chest radiography, or aetiology) was evaluated using the same methodology. RESULTS: The new prediction rule, included the baseline Risk of poor outcome, Interference with daily activities, number of years stopped Smoking (> or <45 years), severity of Sputum, presence of Crackles, and diastolic blood pressure (> or <85 mmHg) (RISSC85). Though performance of RISSC85 was moderate (sensitivity 62%, specificity 59%, positive predictive value 27%, negative predictive value 86%, AUC 0.63, 95% confidence interval [CI] = 0.61 to 0.67), it outperformed all existing prediction rules used today (highest AUC 0.53, 95% CI = 0.51 to 0.56), and could not be significantly improved by including additional test results (highest AUC 0.64, 95% CI = 0.62 to 0.68). CONCLUSION: The new prediction rule outperforms all existing alternatives in predicting poor outcome in adult patients presenting to primary care with acute cough and could not be improved by including additional test results.

Antibiotic prescribing during office hours and out-of-hours: a comparison of quality and quantity in primary care in the Netherlands.

BACKGROUND: Unnecessary and non-first-choice antibiotic prescribing is a significant problem in primary care. It is often argued that irrational prescribing is higher during out-of-hours (OOH) consultations. AIM: To obtain insight into the quantity and quality of OOH antibiotic prescribing for commonly presented infectious diseases. DESIGN AND SETTING: Two two-way comparisons of 1) nationally dispensed antibiotics during office hours and OOH care, using data from the Dutch Foundation of Pharmaceutical Statistics, and 2) regional prescribing quality data from 45 primary care practices from Utrecht and its vicinity, and two large OOH services in Utrecht and Woerden. METHOD: From the national data, yearly dispensed antibiotics were analysed per prescriber type, with respect to time (office hours or OOH) of prescription, types of antibiotics, and patients' age group. Regional prescribing rates, choice of antibiotic, and appropriateness of prescribing were compared for otitis media, sinusitis, tonsillitis, bronchitis, cystitis, and impetigo. Appropriateness was assessed by comparing all relevant information from medical files with the guideline recommendations. RESULTS: Only 6% of GP-prescribed antibiotics were prescribed OOH. OOH, cystitis and acute otitis media presented most often. First-choice prescribing was comparable for the two settings, whereas prescribing rates were higher OOH, with comparatively more amoxicillin(/clavulanate). The appropriateness evaluation, however, revealed that overprescribing was comparable, or even lower than, for daily practice. CONCLUSION: The suggestion that OOH antibiotic prescribing quality is worse than in daily practice does not seem founded. The higher OOH prescribing rates can be explained by a different population of presenting patients. The appropriateness of prescribing rather than prescribing rates, therefore, should be used to determine quality.

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.

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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00353951.

How to develop a program to increase influenza vaccine uptake among workers in health care settings?

BACKGROUND: Apart from direct protection and reduced productivity loss during epidemics, the main reason to immunize healthcare workers (HCWs) against influenza is to provide indirect protection of frail patients through reduced transmission in healthcare settings. Because the vaccine uptake among HCWs remains far below the health objectives, systematic programs are needed to take full advantage of such vaccination. In an earlier report, we showed a mean 9% increase of vaccine uptake among HCWs in nursing homes that implemented a systematic program compared with control homes, with higher rates in those homes that implemented more program elements. Here, we report in detail the process of the development of the implementation program to enable researchers and practitioners to develop intervention programs tailored to their setting. METHODS: We applied the intervention mapping (IM) method to develop a theory- and evidence-based intervention program to change vaccination behaviour among HCWs in nursing homes. RESULTS: After a comprehensive needs assessment, we were able to specify proximal program objectives and selected methods and strategies for inducing behavioural change. By consensus, we decided on planning of three main program components, i.e., an outreach visit to all nursing homes, plenary information meetings, and the appointment of a program coordinator -- preferably a physician -- in each home. Finally, we planned program adoption, implementation, and evaluation. CONCLUSION: The IM methodology resulted in a systematic, comprehensive, and transparent procedure of program development. A potentially effective intervention program to change influenza vaccination behaviour among HCWs was developed, and its impact was assessed in a clustered randomised controlled trial.

Antibiotics for community acquired pneumonia in adult outpatients.

BACKGROUND: Community-acquired pneumonia (CAP), the sixth most common cause of death worldwide, is a common condition representing a significant disease burden for the community, particularly in the elderly. Antibiotics are helpful in treating CAP and are the standard treatment. CAP contributes significantly to antibiotic use, which is associated with the development of bacterial resistance and side-effects. Several studies have been published concerning treatment for CAP. Available data arises mainly hospitalized patients studies. This is an update of our 2004 Cochrane Review. OBJECTIVES: To summarize current evidence from randomized controlled trials (RCTs) concerning the efficacy of different antibiotic treatments for CAP in participants older than 12. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2009, issue 1) which contains the Cochrane Acute Respiratory Infections Group's Specialized Register; MEDLINE (January 1966 to February week 2, 2009), and EMBASE (January 1974 to February 2009). SELECTION CRITERIA: RCTs in which one or more antibiotics were tested for the treatment of CAP in ambulatory adolescents or adults. Studies testing one or more antibiotics and reporting the diagnostic criteria as well as the clinical outcomes achieved, were considered for inclusion. DATA COLLECTION AND ANALYSIS: Two review authors (LMB, TJMV) independently assessed study reports in the first publication. In this update, LMB performed study selection, which was checked by TJMV and MMK. Study authors were contacted to resolve any ambiguities in the study reports. Data were compiled and analyzed. Differences between review authors were resolved by discussion and consensus. MAIN RESULTS: Six RCTs assessing five antibiotic pairs (1857 participants aged 12 years and older diagnosed with CAP) were included. The study quality was generally good, with some differences in the extent of the reporting. A variety of clinical, radiological and bacteriological diagnostic criteria and outcomes were reported. Overall, there was no significant difference in the efficacy of the various antibiotics. AUTHORS' CONCLUSIONS: Currently available evidence from RCTs is insufficient to make evidence-based recommendations for the choice of antibiotic to be used for the treatment of CAP in ambulatory patients. Pooling of study data was limited by the very low number of studies assessing the same antibiotic pairs. Individual study results do not reveal significant differences in efficacy between various antibiotics and antibiotic groups. Multi-drug comparisons using similar administration schedules are needed to provide the evidence necessary for practice recommendations.

Is pacifier use a risk factor for acute otitis media? A dynamic cohort study.

BACKGROUND: Recently, the use of a pacifier has been identified as a risk factor for acute otitis media (AOM). The studies performed so far, however, suffer from methodological limitations. OBJECTIVE: To study whether pacifier use increases the risk of AOM. METHODS: Four hundred and ninety-five children between the ages of 0 and 4 years followed from 2000 to 2005 in a dynamic population study in the Leidsche Rijn residential area in Utrecht, The Netherlands. At baseline, the parents of these children filled out a questionnaire regarding pacifier use and potential confounders. AOM was diagnosed by GPs according to the International Classification of Primary Care coding system. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. RESULTS: Of the 216 children that used a pacifier at baseline, 76 (35%) developed at least one episode of AOM, and of the 260 children that did not use a pacifier, 82 (32%) developed at least one AOM episode; for recurrent AOM, these figures were 33 (16%) versus 27 (11%), respectively. The adjusted ORs for pacifier use and AOM and recurrent AOM were 1.3 (95% CI 0.9-1.9) and 1.9 (95% CI 1.1-3.2), respectively. CONCLUSION: Pacifier use appears to be a risk factor for recurrent AOM. Parents should be informed about the possible negative effects of using a pacifier once their child has been diagnosed with AOM to avoid recurrent episodes.

Illness behaviour and antibiotic prescription in patients with respiratory tract symptoms.

BACKGROUND: Although the vast majority of respiratory tract symptoms are self-limiting, many patients visit their GP for these symptoms and antibiotics are over-prescribed. AIM: To explore determinants of patients visiting GPs for recent cough, sore throat, or earache; for being prescribed antibiotics; and for patients' satisfaction with visiting the GP. DESIGN OF THE STUDY: Second Dutch National Survey of General Practice (DNSGP-2) with a health interview and an additional questionnaire. SETTING: A total of 7057 adult patients of 163 GPs in the Netherlands. METHOD: Characteristics of patients and GPs as well as morbidity data were derived from the DNSGP-2 and a health interview. Characteristics of the symptoms, GPs' management and patients' satisfaction were measured by an additional written questionnaire. Data were analysed by means of multivariate logistic regression. RESULTS: About 40% of the responders (n = 1083) reported cough, sore throat, or earache in the 2 weeks preceding the interview and, of them, 250 visited their GP. Of this latter group, 97 patients were prescribed antibiotics. Apart from non-medical reasons, relevant medical factors played an important role in deciding to visit the GP. Smokers and patients with cardiac disease or diabetes mellitus were not especially inclined to see their GP. Smoking behaviour, fever, and views on respiratory tract symptoms and antibiotics of patients and GPs were associated with being prescribed antibiotics. Patients' perception of having been carefully examined was associated with their satisfaction, while receiving antibiotics was not. CONCLUSION: GPs should inform patients with clear elevated risk when to visit their GP in cases of cough, sore throat, or earache. There is still a need for GPs and patients to be better informed about the limited significance of single inflammation signs (for example, fever and green phlegm) as an indication for antibiotics. Careful examination of the patient contributes to patient satisfaction.