Patient’s Compliance with Oral Antibiotics Treatments at Community Health Centers in Surabaya: A 20-KAO Questionnaire Development

Antibiotics are chemical substances produced by microorganisms that can inhibit or kill bacteria (Fair & Tor, 2014). Antibiotics usage for an infection in the low and middle-income countries has increased up to 65% from 2010-2015 (Klein et al., 2018). An increase has followed the increase in usage in bacterial resistance. The irrational use of antibiotics, such as treating viral infections and usage on the farm and fisheries, correlates with bacterial resistance (Economou & Gousia, 2015). Furthermore, the patient's compliance in taking their oral antibiotics also contributed to bacterial resistance prevalence (Moradi et al., 2013). Several studies evaluated the patient's compliance with oral antibiotics have been conducted using various methods. Measuring compliance using objective or subjective methods has its particular limitations (Jin et al., 2008). Examples of objective methods in assessing patient compliance are pill count and Medication Event Monitoring System (MEMS). Pill count is a physical count of the number of pills that remain and compares to the prescription's instruction (Lam & Fresco, 2015). The MEMS is a medication container contains a microelectronic chip that records the date and time of opening of every bottle (Llor et al., 2013). Although MEMS measures compliance accurately, it cannot be used in an everyday situation. Besides, pill count cannot describe specifically the aspects of compliance, such as timing, dosing, and taking compliance (Willams et al., 2013). Hence, a subjective method such as using a questionnaire is preferable because of less cost, nonjudgmental, non-threatening, quick, and comfortable in Patient’s Compliance with Oral Antibiotics Treatments at Community Health Centers in Surabaya: A 20-KAO Questionnaire Development


INTRODUCTION
Antibiotics are chemical substances produced by microorganisms that can inhibit or kill bacteria (Fair & Tor, 2014). Antibiotics usage for an infection in the low and middle-income countries has increased up to 65% from 2010-2015 (Klein et al., 2018). An increase has followed the increase in usage in bacterial resistance. The irrational use of antibiotics, such as treating viral infections and usage on the farm and fisheries, correlates with bacterial resistance (Economou & Gousia, 2015).
Furthermore, the patient's compliance in taking their oral antibiotics also contributed to bacterial resistance prevalence (Moradi et al., 2013).
Several studies evaluated the patient's compliance with oral antibiotics have been conducted using various methods. Measuring compliance using objective or subjective methods has its particular limitations (Jin et al., 2008). Examples of objective methods in assessing patient compliance are pill count and Medication Event Monitoring System (MEMS). Pill count is a physical count of the number of pills that remain and compares to the prescription's instruction (Lam & Fresco, 2015). The MEMS is a medication container contains a microelectronic chip that records the date and time of opening of every bottle (Llor et al., 2013). Although MEMS measures compliance accurately, it cannot be used in an everyday situation. Besides, pill count cannot describe specifically the aspects of compliance, such as timing, dosing, and taking compliance (Willams et al., 2013). Hence, a subjective method such as using a questionnaire is preferable because of less cost, nonjudgmental, non-threatening, quick, and comfortable in

Patient's Compliance with Oral Antibiotics Treatments at Community Health Centers in Surabaya: A 20-KAO Questionnaire Development
collecting results (Lam & Fresco, 2015;Llor et al., 2013;Ponto, 2015 (Morisky et al., 1986;Thompson et al., 2000;Duong et al., 2001). However, the questionnaires have not been translated and validated into Bahasa Indonesia for measuring compliance with oral antibiotics treatment in Indonesia. A study has been conducted to validate the English version of Morisky 3, 4, and 5-item questionnaires in assessing oral antibiotics compliance (Treibich & Ventelou, 2017).
In Indonesia, measuring oral antibiotics compliance usually uses pill count. Therefore, there has been no questionnaire developed yet. Hence, developing a standard questionnaire for evaluating oral antibiotics compliance in Bahasa Indonesia is essentials. In developing a questionnaire, validity tests are needed in order to evaluate whether it measures what it is supposed to measure or not (Setia, 2017). Validity tests are classified into two broad categories, viz internal and external validity (Bolarinwa, 2015). Internal validity includes content validity that measures the degree to which the instrument comprehensively assesses the construct of interest usually conducted before external validity. Therefore, this study was conducted to record the developed questionnaire's content validity assessing compliance with oral antibiotics.

MATERIALS AND METHODS
This study was conducted observationally from August to September 2020 to establish the evidence of content validity of the developed questionnaire, namely 20-KAO from experts.

20-KAO Questionnaire
The 20-KAO questionnaire was developed in Bahasa Indonesia and aimed to assess short-course oral antibiotics usage compliance. The name 20-KAO was developed from 20 items in assessing compliance with oral antibiotics or in Bahasa Indonesia: Kepatuhan Antibiotik Oral (KAO). The questionnaire was developed in four sections and contained 20 questions. Section one contained ten questions to evaluate whether the patients understood the dosage regimens and took their dosage correctly or not and the reasons behind their action in taking the dosage. Section two rated the patient's understanding, compliance, and the reasons in how many times they took the dosage daily through five questions. In the third section, it was assessed how patients gave an interval between their dosages and the reasons why they did it. In the last section, the patient's understanding of the duration of taking the antibiotics, and whether they had stopped taking the antibiotics before it should be stopped, and their reasons to do so. Additionally, patients were also asked to fill in the number of pills left in the questionnaire and if they used other nonprescribed medication.

Content validation
The literature shows that the ideal number of content experts needed in a validation study is still controversial.
However, the suggestions are between three and ten experts (Polit & Beck, 2006). In this study, a total of six experts were selected. Three of them were academic experts, while three remained were registered pharmacists. These experts' proportion were designed intentionally so that the review results would reflect

RESULTS AND DISCUSSION
All of the six experts invited were agreed to participate. Therefore, S-CVI was calculated at 0.98 as shown in Table I.  However, the experts gave some editorial revisions to make the sentences more comfortable to be understood, as presented in Table II. Among the 20 items validated, the only item with I-CVI less than 1.00 and significant editorial revision was Q11.
The Q11 was developed to assess whether the patients understand how many times they should take their antibiotics or not. Two of the six experts suggested changing the sentence structured because the original sentence was too complicated. Changes in the structure of the questions were then carried out after consultation with these experts. The final form of the 20-KAO questionnaire after the content validity process was shown in Table III.

Apakah
Construct validity is the degree to which an instrument measures the trait or theoretical construct intended to measure, while reliability test is the extent to which a questionnaire produces consistent results on repeated trials (Boateng et al., 2018;Kimberlin & Winterstein, 2008).
Construct validity for the 20-KAO questionnaire is essentials to measure how well the targeted respondents give answers as the questionnaire aims to measure, while the reliability test is useful to assess whether the questionnaire will give consistency in results. Future construct validity and reliability test for 20-KAO questionnaire can be done through distribution to the patient's prescribed antibiotics and then analyze their responses.

CONCLUSION
The 20-KAO questionnaire was found to have excellent content validity based on six experts' reviews. Future construct validity and reliability tests for 20-KAO are needed to be conducted to analyze the respond of targeted respondents and the consistency of the questionnaire.