Construct Validation of the BIOTICA Questionnaire

  • STATUS
    Recruiting
  • participants needed
    85
  • sponsor
    University Hospital, Basel, Switzerland
Updated on 19 February 2024
antibiotics
antibiotic therapy

Summary

Based on barriers identified in a systematic literature search, a self-report questionnaire called "BIOTICA" has been developed by the research team to assess medication adherence barriers to oral AB. The purpose of the BIOTICA-questionnaire is to detect individual barriers that prevent the optimal intake of oral AB and thus, lead to inadequate adherence or persistence to the regimen. A study is now needed to establish construct validity. Correlation between the answers to the BIOTICA-questionnaire and the electronically monitored intake of the oral AB will be analyzed in the general population.

Description

Global consumption of oral antibiotics (AB) is increasing, with 80% of all prescriptions in Europe stemming from primary care, mostly against respiratory tract infections. Adequate intake behavior (i.e. adherence) to oral AB is vital to prevent therapeutic failure, to reduce the risk of microbial resistance, to reduce health care consumption, medication waste and environmental pollution. However, non-adherence among oral AB users reaches rates of 21%-38% during an AB treatment course. To improve medication adherence, understanding patient barriers to treatment is crucial. Based on barriers identified in a systematic literature search, a self-report questionnaire called "BIOTICA" has been developed by the research team to assess medication adherence barriers to oral AB. The purpose of the BIOTICA-questionnaire is to detect individual barriers that prevent the optimal intake of oral AB and thus, lead to inadequate adherence or persistence to the regimen. A study is now needed to establish construct validity (also called criterion, convergent or concurrent validity) that is, to generate evidence that the questionnaire measures what it is intended to. Thus, the instrument under investigation (i.e. BIOTICA-questionnaire) will be distributed at the same time as the targeted attribute (i.e. adherence to oral AB) will be electronically monitored in the general population. The correlation between the two measurements will be analyzed.

Details
Condition Infection
Age 18years - 100years
Treatment Adherence to oral antibiotics assessed by Questionnaire, Persistence to oral antibiotics assessed by Questionnaire
Clinical Study IdentifierNCT04286230
SponsorUniversity Hospital, Basel, Switzerland
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

is 18 years
has a prescription for an oral AB for 3-30 days
self-manages medication
is able to read and understand the German language
signs the Informed Consent Form (ICF)
accepts to record the intake of oral AB with the electronic device Time4Med

Exclusion Criteria

is cognitively impaired
is currently pregnant or actively trying to get pregnant
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