Construct Validation of the BIOTICA Questionnaire (BIOTICA)

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

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.

Study Overview

• Status: Completed
• Conditions: Infectious Diseases and Manifestations
• Intervention / Treatment: Behavioral: Adherence to oral antibiotics assessed by Questionnaire; Behavioral: Persistence to oral antibiotics assessed by Questionnaire

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 Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• Switzerland
  • BS
    • Basel, BS, Switzerland, 4051
      • Apotheke am Spalenbärg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The general population entering a community pharmacy.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Isabelle Arnet, Dr. MD, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Adherence; Oral antibiotics; Electronic monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: 2020-00069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: csv files containing the de-identified patient adherence raw data will be forwarded on request
• IPD Sharing Time Frame: mid 2022
• IPD Sharing Access Criteria: on request to the principal investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No