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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adherence to oral antibiotics assessed by Questionnaire | Behavioral | 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. | ||
| Persistence to oral antibiotics assessed by Questionnaire | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The general population entering a community pharmacy.
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle Arnet, Dr. MD | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Apotheke am Spalenbärg | Basel | Canton of Basel-City | 4051 | Switzerland |
csv files containing the de-identified patient adherence raw data will be forwarded on request
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mid 2022
on request to the principal investigator
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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