Patient Factors Associated With Prescription of Antibiotics for Inappropriate Indication in Patients With AECOPD
Condition: Chronic Obstructive Pulmonary Disease; Acute Exacerbation of COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      Up to 90% of consulting Acute Exacerbation (AE) of COPD patients are prescribed an
      antibiotic(1).

      Rates of inappropriate antibiotic prescription percentage can be as high as 65%(2).

      Excessive use of antibiotics is correlated with higher prevalence of antimicrobial
      resistance(3). There are insufficient data regarding the overprescribing antibiotics in
      AECOPD in our country.Therefore the investigators aimed to investigate the patients factors
      that are associated with the prescription of antibiotic for inappropriate indication in
      AECOPD.This is an observational cross sectional study.Population: AECOPD patients with
      AB(antibiotic) prescription Exposure: Presence of patient factors, Comparison: Absence of
      Patient factors, Outcome: Prescription of antibiotic for inappropriate indication.

      Sampling:

      Consecutive patients presenting to pharmacy between Monday and Friday. Date between January 1
      2017 to January 1 30 2019. Primary Outcome:Prescription of antibiotic for inappropriate
      indication according to Anthonisen criteria for AECOPD Anthonisen criteria:-Worsening of
      dyspnea

        -  Increased sputum volume

        -  Increased sputum purulent 3/3 →Type 1 or severe AE 2/3 →Type 2 or moderate AE 1/3 →Type
           3 or mild AE AB indicated/useful in Type 1 or severe AE, and Type 2 or moderate AE if
           sputum is purulent The data will be obtained from the database.

      Exposure:

      Patient factors that lead to inappropriate antibiotic prescription (will be considered
      together in analysis due to confounding) FEV1% Age Current smoker Comorbidities (Charlson
      comorbidity index) having Frequent exacerbations (≥2 past year) Use of oral steroids
      Polypharmacy Quality control:Detailed MOP will be developed, A manual for protocol will be
      written and used to inform the pharmacist,Pharmacist will be trained; to speak to
      participants in a neutral manner for written informed consent for the security ID(identity)
      data of the patients,This study will not affect the time period of the participants to access
      his/her drug. The pharmacy will use the questionnaire within the time period planned. A
      checklist for exclusion criteria will be developed. A plan for missing data will be
      developed.

      Null hypothesis:

      Patient factors are not associated with the prescription of antibiotics for inappropriate
      indications in patients with AECOPD

      Alternative hypothesis:

      Patient factors are associated with the prescription of antibiotics for inappropriate
      indications in patients with AECOPD Analysis The data will be analysed using SPSS version
      22.0 The investigators will compare exposure variables between inappropriate and appropriate
      prescription groups Continuous variables - t test or Mann Whitney Binary- chi square test The
      investigators will use logistic regression to measure the associations between patient
      factors and the outcome of prescription of antibiotics for inappropriate indication Sample
      size and power Sample size to estimate CI of 15% around 25 to 50% prevalence of inappropriate
      prescription with p=0.05 and Power 80% Expected proportion0,25 128 0,50 171 Sample size and
      power For logistic regression - estimate 30% prevalence (n=143), or about 42 events . The
      investigators also need 5-10 events for each variable in the model, so this provides
      sufficient power for 4 to 8 factors.

      Limitations This study will just determine an association not causality

      The investigators won't be able to determine if the participant is truthful to the pharmacist

      The history of participants will be assessed from hospitals e-database - potential for
      missing data.

      The Anthonisen criteria for identifying inappropriate AB for AECOPD are still debatable The
      investigators can not modify many of the patient factors, but may be able to identify
      patients at higher risk of inappropriate antibiotics Ethics The project will be submitted to
      the ethical committee of Dr. Suat Seren Chest Disease Hospital Oral and written informed
      consent will be obtained from all subjects The study will be conducted in accordance with
      "Good Clinical Practice Guideline" Relevance This study will be the first one to evaluate an
      association between patient factors and prescription of antibiotic for inappropriate
      indication in an outpatient clinic of patients with AECOPD in Turkey.

      Subsequent studies should evaluate physician factors prescription of antibiotic for
      inappropriate indication.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        AECOPD patients with Antibiotic prescription
      
Keywords: copd, aecopd, antibiotic use