Construct Validation of the BIOTICA Questionnaire

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Construct Validation of the BIOTICA Questionnaire (Barriers to Optimal Medication Adherence With Oral Antibiotics)

Conditions
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Infectious Diseases and Manifestations

Intervention / Treatment
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* Behavioral: Adherence to oral antibiotics assessed by Questionnaire
* Behavioral: Persistence to oral antibiotics assessed by Questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Adherence to oral antibiotics assessed by Questionnaire|The purpose of the BIOTICA-questionnaire is to detect individual barriers preventing the optimal intake of oral antibiotics and thus, leading to inadequate adherence or persistence to the regimen.|
|Behavioral: Persistence to oral antibiotics assessed by Questionnaire|The purpose of the BIOTICA-questionnaire is to detect individual barriers preventing the optimal intake of oral antibiotics and thus, leading to inadequate adherence or persistence to the regimen.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence [%] to oral antibiotics | The primary endpoint is the adherence [%] to oral antibiotics calculated as correct dosing days from the electronic adherence data | maximum 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistence [%] to oral antibiotics | The secondary endpoint is persistence [%] to oral antibiotics defined as the time until medication discontinuation and calculated as the percentage of days with at least one intake | maximum 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence, Oral antibiotics, Electronic monitoring