Construct Validation of the BIOTICA Questionnaire
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed 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.
Study Design
Outcome Measures
Primary Outcome Measures
- Adherence [%] to oral antibiotics [maximum 30 days]
The primary endpoint is the adherence [%] to oral antibiotics calculated as correct dosing days from the electronic adherence data
Secondary Outcome Measures
- Persistence [%] to oral antibiotics [maximum 30 days]
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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Apotheke am Spalenbärg | Basel | BS | Switzerland | 4051 |
Sponsors and Collaborators
- University Hospital, Basel, Switzerland
Investigators
- Principal Investigator: Isabelle Arnet, Dr. MD, University Hospital, Basel, Switzerland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-00069