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Original Investigation |

Prescription Strategies in Acute Uncomplicated Respiratory Infections A Randomized Clinical Trial

Mariam de la Poza Abad, MD1; Gemma Mas Dalmau, MD2; Mikel Moreno Bakedano, MD, PhD3; Ana Isabel González González, MD4,5,6; Yolanda Canellas Criado, MD7; Silvia Hernández Anadón, MD, PhD8; Rafael Rotaeche del Campo, MD6,9; Pere Torán Monserrat, MD10,11; Antonio Negrete Palma, MD11; Laura Muñoz Ortiz, MD10; Eulàlia Borrell Thió, MD12; Carl Llor, MD, PhD13; Paul Little, MD14; Pablo Alonso-Coello, MD, PhD2,6,15 ; for the Delayed Antibiotic Prescription (DAP) Group
[+] Author Affiliations
1Doctor Carles Ribas Primary Care Center, Barcelona, Spain
2Iberoamerican Cochrane Center, Biomedical Research Institute Sant Pau, Barcelona, Spain
3Irurtzun Primary Care Center, Irurtzun, Spain
4Vicente Muzas Primary Care Center, Madrid, Spain
5Red de investigación en Servicios de Salud en Enfermedades Crónicas, Spain
6Evidence-Based Medicine Group, SemFYC, Spain
7Monovar Primary Care Center, Madrid, Spain
8Jaume I Primary Care Center, Tarragona, Spain
9Alza Osakidetza Primary Care Center, Kronikgune Group about Knowledge Management, Basque Health Service, Spain
10Research Support Unit Metropolitana Nord, Jordi Gol University Institute for Research Primary Healthcare, Santa Coloma de Gramenet, Spain
11El Maresme Primary Care Center, Mataró, Spain
12Sant Roc Primary Care Center, Badalona, Spain
13Via Roma Primary Care Center, Barcelona, Spain
14Aldermoor Primary Care Center, Aldermoor Close, Southampton, United Kingdom
15CIBER de Epidemiología y Salud Pública, Spain
JAMA Intern Med. 2016;176(1):21-29. doi:10.1001/jamainternmed.2015.7088.
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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

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Patient Randomization Flowchart

Flowchart following the randomization of patients to different prescription strategies to final analysis.

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