Development and content validation of a mobile application for monitoring latent tuberculosis treatment

Novaes, Marcelle Temporim; Prado, Thiago Nascimento do; Delcarro, Jessica Cristina Silva; Rissino, Silvia das Dores; Crepaldi, Nathalia Yukie; Sanches, Tiago Lara Michelin; Arnizant, Thomaz Felipe Soares; Alves, Domingos; Maciel, Ethel Leonor Noia

doi:10.1590/0037-8682-0465-2021

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Short Communication • Rev. Soc. Bras. Med. Trop. 55 • 2022 • https://doi.org/10.1590/0037-8682-0465-2021 copy

Development and content validation of a mobile application for monitoring latent tuberculosis treatment

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

Background:

Non-compliance with latent tuberculosis infection (LTBI) treatment is a reality. The objective of this study was to develop and validate an mobile device application for monitoring the treatment of LTBI.

Methods:

We defined the requirements, elaborated on the application's conceptual map, generated implementation and prototyping alternatives, and validated content.

Results:

Feedback on the validity of content were: “usefulness, consistency, clarity, objectivity, vocabulary, and precision” from professionals, and “clarity” from patients.

Conclusions:

The application proved to be easy to understand, according to the assessment of both professionals and people undergoing treatment for LTBI.

Keywords:
Validation studies; Mobile health; Latent tuberculosis

Evaluated items	Judgment (%)					CVI	Evaluated requirements	Suggestions
	1*	2*	3*	4*	5*
1.The name of the application will be “Tratamento Virtualmente Observado da Tuberculose (TVO-TB)”. Do you think this name is appropriate?	28.6	14.3	28.6	-	28.6	0.25	Usefulness	Change to preventive treatment or tuberculosis - monitoring.
							Consistency
							Precision
2.Will this app name be able to draw the attention of patients with LTBI?	28.6	14.3	28.6	-	28.6	0.25	Usefulness	Change to “Meu tratamento ILTB” or “Prevenindo TB”.
							Consistency
							Clarity
							Vocabulary
3.The app will have a space for information about LTBI. Do you consider this space adequate?	-	-	-	14.3	85.7	1	-	-
4.The space that will have information about LTBI will be in the form of conversation balloons with a professional talking to the patient. Do you think this will be the best way to show this space?	-	14.3	14.3	57.1	14.3	0.75	Usefulness	-
5.Do you consider the question: “What is LTBI?” important within the app?	-	-	-	14.3	85.7	1	-	-
6.The question “What is LTBI?” will have the answer: “LTBI is Latent Tuberculosis Infection. Latent is that it is not manifesting, or that it is asleep. LTBI occurs when a person is contaminated by a bacteria called Mycobacterium tuberculosis. Look at what this bacterium looks like (image of the bacterium). It does not mean that everyone who is contaminated by the bacteria will get sick with the active form of Tuberculosis. In general, infected people remain healthy for many years, without transmitting the bacteria, and with partial immunity to the disease”. How do you rate this answer?	-	-	28.6	14.3	57.1	0.75	Objectivity	Include the information: “If left untreated, the disease can appear in its most severe form”.
7.You consider the question: “Which are the signs and symptoms of LTBI?” important within the app?	14.3	14.3	-	14.3	57.1	0.75	Clarity	Change to affirmative “Which are the signs and symptoms?”
8.The question “Which are the signs and symptoms of LTBI?” will have the following answer: “In most cases of people with LTBI the bacteria is dormant and, thus, it does not progress or cause illness. Then the patient asks the question: But how will I know if I have LTBI? and the professional will answer: When a specific exam is performed by a health professional”. How do you rate this answer?	-	28.6	14.3	28.6	28.6	0.62	Clarity and Precision	Change to affirmative “Which are the signs and symptoms?”
9.You consider the question: “What is the treatment time?” important within the app?	-	-	-	14.3	85.7	1	-	-
10.The question “Which is the treatment time?” will have the following answer: “When you are treated with the Isoniazid antibiotic, the number of doses of the drug taken, not just the length of treatment, is most important. Depending on the amount of dose your doctor gives, the treatment can last from 6 to 9 months, or even 12 months”. How do you rate this answer?	-	14.3	-	57.1	28.6	0.87	-	-
11.Within the space “Which is the treatment time?” there will be a continuation of a conversation between the patient and the professional in which the patient reports: “But if I'm not feeling anything, why am I going to take medication?” then the professional answers: “You will take the medication so that LTBI does not turn into active TB”. How do you rate this answer?	-	14.3	14.3	42.8	28.6	0.75	Vocabulary	Include “There are benefits to treating at this moment, reducing the chances of getting sick from TB”.
12.You consider the question: “What can I feel during treatment?” important?	-	-	-	14.3	85.7	0.87	-	-
13.The question “What can I feel during treatment?” will have the following answer: “You will hardly experience any of these signs and symptoms, but if it happens you may present: Nausea and vomiting, stomach pain, itching, red rash on the skin, joint pain, hands and feet may have weakness or numbness and pain due to damage to these nerves, headache and change of behavior, fever”. All these signs and symptoms will be accompanied by images and captions for ease of understanding. How do you rate this answer?	-	28.6	-	14.3	57.1	0.75	Usefulness and Consistency	Include hepatotoxicity. Replace the word “nausea” with “sickness”.
14.Within this topic “What can I feel during treatment?” will have the information of the professional: “If you have one of these signs (rash, delusions, hallucinations and seizures), contact your health unit immediately and don't forget to report it in the app”. Do you think this information is adequate?	-	-	14.3	28.6	42.8	0.75	Clarity	Replace the term “eruption” with “spots”.
15.Do you consider the following question important: “What happens if I don't take the medication?”	-	-	-	14.3	71.4	1	-	-
16.The question “What happens if I don't take the medication?” will have the following answer: “If you don't take your medication at the right times or even decide not to follow your treatment anymore, you could develop TB, and you know what's worse? Maybe this antibiotic you used this time, it has a great chance of not helping you in the other treatment”. And the patient asks: “So what should I do?” The professional answers: “The ideal is for you to do all your treatment, we are here to help you on this mission, we need you, your health is very important to us”.	14.3	-	-	28.6	57.1	0.87	-	-
17.The app will have a space for the “medication time”, with the following question: “What time do you want to take the medication?”. Do you think this space is important?	-	-	14.3	-	85.7	0.87	-	-
18.The app will have a space where the patient will report what they are feeling. In this space there will be pictures and legends identifying what the patient may feel during their treatment period. For example: When referring to itch, there will be an image of a person scratching themselves and below it will have the word itch written. Do you think it's important?	-	-	-	28.6	71.4	1	-	-
19.The app will have an option called calendar, this space will have information about the initiation, end and current day of treatment. Do you think the word “Calendar” would be ideal to identify this information?	-	14.3	-	57.1	28.6	0.75	Vocabulary	Replace calendar with “Treatment period”.
20.The app will have a voice command that will speak what the patient is reading within the app. Do you consider this information important?	-	-	14.3	-	85.7	0.87	-	-

Items without changes	Reformulated items	CVI of the reformulated items
1.The name of the application will be “Tratamento Virtualmente Observado da Tuberculose (TVO-TB)”. Do you think this name is appropriate?	The application name will be “Meu tratamento ILTB”. Do you think this name is appropriate?	0.71
2.Will this app name be able to draw the attention of patients with LTBI?	This application name will be able to draw the attention of patients with latent tuberculosis infection (LTBI)?	0.71
4.The space that will have information about LTBI will be in the form of conversation balloons with a professional talking to the patient. Do you think this will be the best way to show this space?	Within the application there will be an “information” menu option; in this part, the patient will have access to important information about LTBI. All this information will be presented with conversation balloons with a professional talking to the patient. Do you think this will be the best way to show this information?	0.86
6.The question “What is LTBI?” will have the following answer: “LTBI is Latent Tuberculosis Infection. Latent is that it is not manifesting, or that it is asleep. LTBI occurs when a person is contaminated by a bacteria called Mycobacterium tuberculosis. Look at what this bacterium looks like (image of the bacterium). It does not mean that everyone who is contaminated by the bacteria will get sick with the active form of TB. In general, infected people remain healthy for many years, without transmitting the bacteria, and with partial immunity to the disease”. How do you rate this answer?	The question “What is LTBI?” will have the following answer: “LTBI is Latent Tuberculosis Infection. Latent is that it is not manifesting, or that it is asleep. LTBI occurs when a person is contaminated by a bacteria called Mycobacterium tuberculosis. Look at what this bacterium looks like (image of the bacterium). It does not mean that everyone who is contaminated by the bacteria will get sick with the active form of TB. In general, infected people remain healthy for many years, without transmitting the bacteria, and with partial immunity to the disease”. It is noteworthy that, if left untreated, the disease can appear and even more severely. How do you rate this answer?	0.86
7.You consider the question: “Which are the signs and symptoms of LTBI?” important within the app?	Do you consider the statement important: “Signs and Symptoms of LTBI” important within the app?	0.86
8.The question “Which are the signs and symptoms of LTBI?” will have the following answer: “In most cases of people with LTBI the bacteria is dormant and, thus, it does not progress or cause illness. Then the patient asks the question: But how will I know if I have LTBI? and the professional will answer: When a specific exam is performed by a health professional”. How do you rate this answer?	The statement “LTBI signs and symptoms” will have the following content: “In most cases of people with LTBI the bacteria is dormant and, thus, it does not progress or cause illness. Then the patient asks the question: But how will I know if I have LTBI? and the professional will answer: When a specific exam is performed by a health professional”. How do you rate this answer?	0.86
11.Within the space “Which is the treatment time?” there will be a continuation of a conversation between the patient and the professional in which the patient reports: “But if I'm not feeling anything, why am I going to take medication?” then the professional answers: “You will take the medication so that LTBI does not turn into active TB”. How do you rate this answer?	Within the information menu there will be the question “What is the treatment time?”, with a continuation of a conversation between the patient and the professional in which the patient reports: “But if I'm not feeling anything, why am I going to take medication?” and the professional will answer: “You will take your medication, because there are benefits in treating it at this moment, reducing the chances of getting sick from TB. How do you rate this answer?	0.86
13.The question “What can I feel during treatment?” will have the following answer: “You will hardly experience any of these signs and symptoms, but if it happens you may present: Nausea and vomiting, stomach pain, itching, red rash on the skin, joint pain, hands and feet may have weakness or numbness and pain due to damage to these nerves, headache and change of behavior, fever”. All these signs and symptoms will be accompanied by images and captions for ease of understanding. How do you rate this answer?	The question “What can I feel during treatment?” will have the following answer: “You will hardly experience any of these signs and symptoms, but if it happens you may present: Nausea and vomiting, stomach pain, itching, red rash on the skin, joint pain, hands and feet may have weakness or numbness and pain due to damage to these nerves, headache and change in behavior, fever, and hepatotoxicity (it is liver damage that can be caused by the medication)”. All these signs and symptoms will be accompanied by images and captions for ease of understanding. How do you rate this answer?	0.86
14.Within this topic “What can I feel during treatment?” will have the information of the professional: “If you have one of these signs (rash, delusions, hallucinations and seizures), contact your health unit immediately and don't forget to report it in the app”. Do you think this information is adequate?	Also within this topic “What can I feel during treatment?” will have the information of the professional speaking: “If you have one of these signs below (skin patches, delusions, hallucinations, seizures), immediately contact your health unit and don't forget to report it in the app”. Do you think this information is adequate?	0.86
19.The app will have an option called calendar, this space will have information about the initiation, end and current day of treatment. Do you think the word “Calendar” would be ideal to identify this information?	The application will have a “Treatment period” option with information on the initiation, end and current day of treatment. Do you think the term “Treatment Period” would be ideal to identify this information?	1

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[1] Corresponding author: Dr. Ethel Leonor Noia Maciel. e-mail:ethel.maciel@gmail.com