Rationale, design and organization of the delayed antibiotic prescription (DAP) trial: a randomized controlled trial of the efficacy and safety of delayed antibiotic prescribing strategies in the non-complicated acute respiratory tract infections in general practice.

BACKGROUND: Respiratory tract infections are an important burden in primary care and it's known that they are usually self-limited and that antibiotics only alter its course slightly. This together with the alarming increase of bacterial resistance due to increased use of antimicrobials calls for a need to consider strategies to reduce their use. One of these strategies is the delayed prescription of antibiotics. METHODS: Multicentric, parallel, randomised controlled trial comparing four antibiotic prescribing strategies in acute non-complicated respiratory tract infections. We will include acute pharyngitis, rhinosinusitis, acute bronchitis and acute exacerbation of chronic bronchitis or chronic obstructive pulmonary disease (mild to moderate). The therapeutic strategies compared are: immediate antibiotic treatment, no antibiotic treatment, and two delayed antibiotic prescribing (DAP) strategies with structured advice to use a course of antibiotics in case of worsening of symptoms or not improving (prescription given to patient or prescription left at the reception of the primary care centre 3 days after the first medical visit). DISCUSSION: Delayed antibiotic prescription has been widely used in Anglo-Saxon countries, however, in Southern Europe there has been little research about this topic. The DAP trial wil evaluate two different delayed strategies in Spain for the main respiratory infections in primary care. TRIAL REGISTRATION: This trial is registered with ClinicalTrials.gov, number http://NCT01363531.

Effectiveness of regular reporting of spirometric results combined with a smoking cessation advice by a primary care physician on smoking quit rate in adult smokers: a randomized controlled trial. ESPIROTAB study.

BACKGROUND: Undiagnosed airflow limitation is common in the general population and is associated with impaired health and functional status. Smoking is the most important risk factor for this condition. Although primary care practitioners see most adult smokers, few currently have spirometers or regularly order spirometry tests in these patients. Brief medical advice has shown to be effective in modifying smoking habits in a large number of smokers but only a small proportion remain abstinent after one year. The aim of this study is to evaluate the effectiveness of regular reporting of spirometric results combined with a smoking cessation advice by a primary care physician on smoking quit rate in adult smokers. METHODS/DESIGN: Intervention study with a randomized two arms in 5 primary care centres. A total of 485 smokers over the age of 18 years consulting their primary care physician will be recruited.On the selection visit all participants will undergo a spirometry, peak expiratory flow rate, test of smoking dependence, test of motivation for giving up smoking and a questionnaire on socio-demographic data. Thereafter an appointment will be made to give the participants brief structured advice to give up smoking combined with a detailed discussion on the results of the spirometry. After this, the patients will be randomised and given appointment for follow up visits at 3, 6, 12 and 24 months. Both arms will receive brief structured advice and a detailed discussion of the spirometry results at visit 0. The control group will only be given brief structured advice about giving up smoking on the follow up. Cessation of smoking will be tested with the carbon monoxide test. DISCUSSION: Early identification of functional pulmonary abnormalities in asymptomatic patients or in those with little respiratory symptomatology may provide "ideal educational opportunities". These opportunities may increase the success of efforts to give up smoking and may improve the opportunities of other preventive actions to minimise patient risk. Comparing adult smokers in the intervention group with those in the control group, a minimum improvement expected with respect to the rates of smoking cessation would represent a large number of avoided morbimortality. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01296295.

Prescription Strategies in Acute Uncomplicated Respiratory Infections: A Randomized Clinical Trial.

IMPORTANCE: Delayed antibiotic prescription helps to reduce antibiotic use with reasonable symptom control. There are different strategies of delayed prescription, but it is not yet clear which one is the most effective. OBJECTIVE: To determine the efficacy and safety of 2 delayed strategies in acute, uncomplicated respiratory infections. DESIGN, SETTING, AND PARTICIPANTS: We recruited 405 adults with acute, uncomplicated respiratory infections from 23 primary care centers in Spain to participate in a pragmatic, open-label, randomized clinical trial. INTERVENTIONS: Patients were randomized to 1 of 4 potential prescription strategies: (1) a delayed patient-led prescription strategy; (2) a delayed prescription collection strategy requiring patients to collect their prescription from the primary care center; (3) an immediate prescription strategy; or (4) a no antibiotic strategy. Delayed prescription strategies consist of prescribing an antibiotic to take only if the symptoms worsen or if there is no improvement several days after the medical visit. MAIN OUTCOMES AND MEASURES: The primary outcomes were the duration of symptoms and severity of symptoms. Each symptom was scored using a 6-point Likert scale (scores of 3 or 4 were considered moderate; 5 or 6, severe). Secondary outcomes included antibiotic use, patient satisfaction, and patients' beliefs in the effectiveness of antibiotics. RESULTS: A total of 405 patients were recruited, 398 of whom were included in the analysis; 136 patients (34.2%) were men; mean (SD) age, 45 (17) years. The mean severity of symptoms ranged from 1.8 to 3.5 points on the Likert scale, and mean (SD) duration of symptoms described on first visit was 6 (6) days. The mean (SD) general health status on first visit was 54 (20) based on a scale with 0 indicating worst health status; 100, best status. Overall, 314 patients (80.1%) were nonsmokers, and 372 patients (93.5%) did not have a respiratory comorbidity. The presence of symptoms on first visit was similar among the 4 groups. The mean (SD) duration of severe symptoms was 3.6 (3.3) days for the immediate prescription group and 4.7 (3.6) days for the no prescription group. The median (interquartile range [IQR]) of severe symptoms was 3 (1-4) days for the prescription collection group and 3 (2-6) days for the patient-led prescription group. The median (IQR) of the maximum severity for any symptom was 5 (3-5) for the immediate prescription group and the prescription collection group; 5 (4-5) for the patient-led prescription group; and 5 (4-6) for the no prescription group. Patients randomized to the no prescription strategy or to either of the delayed strategies used fewer antibiotics and less frequently believed in antibiotic effectiveness. Satisfaction was similar across groups. CONCLUSIONS AND RELEVANCE: Delayed strategies were associated with slightly greater but clinically similar symptom burden and duration and also with substantially reduced antibiotic use when compared with an immediate strategy. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01363531.