Comparative evaluation of efficacy of a smartphone application for oral submucous fibrosis (OSMF) self-examination in follow-up of the patients compared to routine Outpatient Department-based follow-up: a clinical interventional study

Komal Vilas Dadgal; Swapnil C. Mohod; Vidya Lohe; Shraddha Patel

doi:10.12688/f1000research.133893.1

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Comparative evaluation of efficacy of a smartphone application for oral submucous fibrosis (OSMF) self-examination in follow-up of the patients compared to routine Outpatient Department-based follow-up: a clinical interventional study

[version 1; peer review: 1 approved with reservations, 1 not approved]

Komal Vilas Dadgal ¹, Swapnil C. Mohod¹, Vidya Lohe¹, Shraddha Patel¹

PUBLISHED 08 Mar 2024

Author details Author details

¹ DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY, DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH, WARDHA, MAHARASHTRA, 442001, India

Komal Vilas Dadgal
Roles: Funding Acquisition, Investigation, Writing – Original Draft Preparation, Writing – Review & Editing

Swapnil C. Mohod
Roles: Conceptualization, Resources, Software, Supervision, Validation, Visualization

Vidya Lohe
Roles: Data Curation, Formal Analysis

Shraddha Patel
Roles: Methodology, Project Administration

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Background: Sushruta (600 B.C.) described a condition called "Vidari" linked with progressive narrowing of mouth, depigmentation of the oral mucosa, and pain on taking food, oral submucous fibrosis (OSMF). In 1952, Schwartz called this illness, which affected five Indian women existing in Kenya, "atrophica idiopathica mucosae oris." Pindborg and Sirsat coined the term "oral submucous fibrosis" in 1966, which is still in use today. With an overall Indian prevalence rate of between 0.2–0.5%, OSMF is primarily found in India and Southeast Asia, according to global estimations. Patients with OSMF need regular follow-ups and to maintain this follow-up it is not always possible for the patient to visit a dental clinic. Hence developing a smartphone-based application for the follow-up of OSMF will be of great value to the patients. The study aims to evaluate the effectiveness of a smartphone application on OSMF self-examination in the follow-up of patients.
Methods: There will be three phases of the research. The first phase will be the development of a smartphone-based application for the follow-up of patients with OSMF. The second phase will be distribution and training the patients regarding the usage of the application and the third phase will be evaluating the effectiveness of the smartphone application in maintaining the follow-up of the patients.
Expected results: The follow-up of patients with OSMF is expected to be better and feasible using a smartphone application as compared to regular Outpatient Department-based follow-up.
Conclusions: Designing a mobile application for the ease of users presents difficulties since it must take accessibility into account, which influences how well the application is received by users. The goal of OSMF examination awareness facilitation and intervention is to raise public knowledge. Educational activities significantly contribute to the advancement of information, convictions, and OSMF screening practice.
CTRI registration: CTRI/2023/06/054514 (registration pending)

Keywords

oral submucous fibrosis, self-examination, follow-up, smartphone applications, public awareness

Corresponding authors: Komal Vilas Dadgal, Swapnil C. Mohod

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2024 Dadgal KV et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The author(s) is/are employees of the US Government and therefore domestic copyright protection in USA does not apply to this work. The work may be protected under the copyright laws of other jurisdictions when used in those jurisdictions.

How to cite: Dadgal KV, Mohod SC, Lohe V and Patel S. Comparative evaluation of efficacy of a smartphone application for oral submucous fibrosis (OSMF) self-examination in follow-up of the patients compared to routine Outpatient Department-based follow-up: a clinical interventional study [version 1; peer review: 1 approved with reservations, 1 not approved]. F1000Research 2024, 13:165 (https://doi.org/10.12688/f1000research.133893.1) First published: 08 Mar 2024, 13:165 (https://doi.org/10.12688/f1000research.133893.1) Latest published: 14 May 2025, 13:165 (https://doi.org/10.12688/f1000research.133893.2)

Introduction

Background

The World Health Organization (WHO) described this condition as “a slowly progressing disease in which fibrous bands form in the oral mucosa, ultimately leading to the severe restriction of movement of the mouth including tongue” in 1978.¹ In 2019, More and Rao described it as “a debilitating, progressive, irreversible collagen metabolic disorder induced by chronic chewing of areca nut and its commercial preparations; affecting the oral mucosa and occasionally the pharynx and esophagus; leading to mucosal stiffness and functional morbidity, and has a potential risk of malignant transformation”.²^,³

Prevalence

According to estimates, 7–30% of oral submucous fibrosis (OSMF) cases will develop into oral squamous cell carcinoma (OSCC).⁴ Due to the high malignant transformation rate of this illness (1.5–15%), death rates are high. OSMF incidence varies by area and ethnicity and is strongly correlated with culture, habits, and diet.⁵ Patients with OSMF are most predominant in South and South-East Asia. The high percentage of Indian immigrants in South Africa also contributes to the high prevalence of patients with OSMF there.⁶ Different South-East Asian nations have different oral submucous fibrosis (OSMF) prevalence rates. According to statistics, the prevalence is 0.9–4.7% in China, 0.6–6.42% in India, 0.15–14.6% in Vietnam, and 0.086–17.6% in Taiwan. According to statistics from WHO, more than five million individuals are living with OSMF worldwide.⁷ Patients with OMSF can range from 8 to 80 years old, and the mean age varies between studies.

OSMF is closely linked with the use of betel nut/areca nut, which is classified as grade I hazard by WHO. The use of betelnut is very common in the Indian population being part of cultural events. The betelnut and its products are easily accessible.⁸ Various preparations of betel nut including smokeless tobacco, e.g., kharra, gutkha, and processed packed supari, are very common in this region, giving rise to the number of patients with OSMF.

The oral mucosa of patients with the condition has a leathery feel and perceptible vertical fibrous bands, which finally restricts mouth opening and makes the tongue hard. Early signs of the condition include a burning feeling when eating spicy food, losing normal pigmentation, and blanching of the mucosa. Ulcers, dry mouth, burning in the mouth, and restricted mouth opening are some of the clinical symptoms of OSMF.⁹ As the condition worsens, it could cause distress to the throat and esophagus, causing fibrosis of the upper digestive tract, while mouth-opening limitation is triggered by fibrosis of oral mucosa in the late phases of OSMF. Oral mucosa blanching is a significant clinical characteristic in the initial phases.⁷ Life quality is directly impacted by the characteristic manifestations and signs of OSMF patients who exhibit a constrained mouth opening.⁵ It should be noted that many patients with OSMF exhibit symptoms of anxiety, sadness, stress, and poor social interaction, and the incidence of these symptoms is contrarywise linked with the ailment’s severity.²

A mobile application containing material that is specifically designed for end users, such as the general public, may increase the intervention’s acceptability and effectiveness. The creation of mobile applications that incorporate theory may emphasize and support behavior modification for health promotion in patients with OSMF.¹⁰ Public health promotion will be practiced by the built mobile application. Therefore, enhancing the mobile application’s visual appeal, usability, acceptance, and effectiveness is necessary.¹¹

Objectives

Phase 1: Development of an evidence based self-assessment smartphone application:

a. To develop evidence based relevant content for the development of a user-friendly self-assessment smartphone application for patients with OSMF.

Phase 2: Distribution of the smartphone application:

a. To train and counsel patients regarding the utilization of the smartphone application.
b. To modify the application as per the requirement and suggestions of the user.

Phase 3: To assess the outcome of the smartphone-based application on patient follow-up:

a. To assess the efficacy of smartphone self-assessment application in maintaining the follow-up of the patients.

Methods

Ethical considerations

Ethical approval has been received from Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha IEC reference number DMIHER (DU)/2023/568. Consent from the intervention group will be taken using electronic consent forms. For the routine outpatient department (OPD)-based follow-up, written consent form will be taken manually. This clinical trial study protocol adhered to the SPIRIT checklist.¹⁶

Study setting

After getting ethical approval from “The Institutional Ethics Committee (IEC)” of Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, for this study, the patients will be selected as per the inclusions and exclusions given in the criteria. The study will be conducted at Sharad Pawar Dental College, Sawangi (Meghe), Wardha in the Dept. of Oral Medicine and Radiology.

Eligibility criteria

The investigator will perform the intervention with the following inclusion and exclusion criteria.

Inclusion criteria

1. Patients habitual to betelnut chewing (more than six months duration).
2. Patients clinically diagnosed with OSMF.
3. Patients having an acceptable literacy level (e.g., are able to read and write Hindi, Marathi, and English).
4. Patients having access to smartphones.
5. Patients who are able to provide electronic informed consent.

Exclusion criteria

1. Patients who refuse to take part in the study will not be included.
2. Patients having malignant lesions are also excluded from the study.
3. Patients who are unable to read the application’s teaching materials on their smartphones.

Intervention

The participants of the intervention group will be given access to smartphone application for the follow-up of the OSMF. Whereas the control group will not be given access to the application. The participants in the control group will be referred to the OPD for the follow-up of OSMF.

The intervention will be accustomed for seven months. The initial two months will be the training period for the participants for the usage and various features of the smartphone application. The smartphone application will also be surveyed for any modifications in the smartphone application.

The smartphone application will contain monthly and weekly follow-ups for the users and information regarding the disease and ill-effects of the use of betelnut and its products. After downloading the application, the user will have to fill the demographic details for the sign-in of the application. After the sign-in, the user will have access to follow-up section and the information available on the smartphone application. The user can follow the steps and answer the questions of the follow-up for the monthly and weekly follow-up.

To improve the adherence of the participants in the intervention group, the smartphone application will have a feature of notification reminder to adhere to the follow-up of OSMF on weekly and monthly basis.

Outcomes

The outcomes of the study will be regular follow-up of the patients who have OSMF or have the habit of betel-nut chewing. The participants can adhere to the follow-up more efficiently using the smartphone application for the follow-up and inspect for the improvement of the signs of OSMF on their own.

Participant timeline

After introducing the participants of the intervention group to the smartphone application, they will perform the weekly and monthly follow-ups for the period of 6 months.

Sample size

n_{0} = ⌈\frac{{(Z_{α} + Z_{β})}^{2} (σ_{1}^{2} / γ + σ_{0}^{2})}{{(d - δ)}^{2}}⌉ .

• Significance level Type I error rate, α = 0.05
• Power (1-beta) = 0.8
• Z alpha value = at 90% 1.645
• Z beta value = at 80% 0.842
• Ratio of sample size, Treatment/control =1
• Allowable difference, d = μT− μC = 0.7
• Expected population standard deviation, SD = 1.5
• δ(>0), Margin = 1.1
• Drop rate (%) = 10

G power software analysis

Ratio var1/var0 = 1.5

α err prob = 0.05

Power (1-β err prob) = 0.95

Lower critical χ² = 49.10

Upper critical χ² = 120.32

Df = 80

Total sample size = 110

Actual power = 0.90

Result

The total sample size will be 110 participants. Sample size depends on the true mean difference, d, standard deviations for the two groups, and a level of significance α (type|error), and the power. The total sample size n = n₁ + n₀ is minimized when r = σ₁/σ₀. With the aforementioned calculation, sample size determination with a 90% of confidence interval is 110, considering drop outs.

Recruitment

All the patients visiting the out-patient department (OPD) will be thoroughly inspected for the habit of betelnut chewing and will be introduced to the smartphone application which will be developed. They will be explained about the efficacy of the use of the application for the follow-up of the habit and OSMF which will also help the to cease the habit.

Allocation

Sequence generation for both the groups will be done using simple randomization.

Allocation concealment mechanism

The mechanism of implementing the allocation sequence is by sequential numbering.

Implementation

The investigator will generate the allocation sequence, enroll the participants, and will assign the participants to intervention and the control group.

Blinding

The participants belonging to both, intervention and control groups will be blinded.

Phases

Phase 1: Development of the self-assessment smartphone application

The evidence-based informational materials on OSMF, cancer prevention, and self-examination will be taken from reliable sources such as articles published in indexed journal i.e scopus, pubmed and web of sciences.¹² Following which, the contents will be modified, and animated educational videos will be created. Then, with the assistance of professionals in the creation of electronic content, the materials will be created with modifying rules and converting lessons to electronic formats, images, animations, also audio and video clips will be included.¹¹

The resources will then be created using Android Studio, a software development environment for the Android platform, in the form of installable applications for mobile devices.

The application will be multilingual.

The OSMF application will consist of two components: the OSMF self-assessment and the OSMF educational resources.¹¹

The participants’ smart electronic devices will have the application downloaded, and it can be utilized online. Patients will also be trained by the researcher for the handling of the application. It should be noted that an internet connection will be necessary for the application’s installation.

Phase 2: Distribution of the application

The created application will be put on the smartphones of the participants in the following phase, and its functionality will be inspected. The patients will be trained to use the application along with motivation and counselling. After a month of testing, participants will be requested to get in touch with the researcher if they encounter any issues or have any concerns about using the application.¹¹

Phase 3: To assess the outcome of the smartphone-based application on patient follow-up

The data generated from application will be used to assess: i) Patient compliance; ii) modifications in symptoms; and iii) analysis of patient feedback will be done.

The study will be conducted in two groups: i) Group I: the control group, routine OPD-based follow-up (55) and ii) Group II: the smartphone application using group (55). The control group will be monitored by the conventional follow-up method of assessment in patients with OSMF and the latter group will be monitored through the self-assessment smartphone application. Depending on the findings of the two comparative groups, the efficacy of the application will be tested in maintaining the follow-up in the patients with OSMF.

Data collection

The data will be collected from the patients for follow-up of OSMF visiting OPD for the control group. The data of the participants using the self-assessment smartphone application for OSMF follow-up who belongs to the intervention group will be stored in the application which can be accessed by the investigator. The data collected include demographic details such as age, address, contact details. Data will also be collected from the questionnaire of the self-assessment application for OSMF follow-up.

Retention

The participants will get regular reminder notifications on their smartphone application which they will be using for the follow-up of OSMF which will improve participant retention. This will also ensure complete follow-up of the participants of the intervention group.

Data management

For the maintenance of the data quality, once the data is collected from the participants of the control and intervention group it will be cross-checked by all the investigators.

Statistical analysis

Descriptive and frequency distribution will be used for demographic data. Chi-squared test and Pearson’s correlation analysis will be used to assess the impact of variables. A linear regression model will help to assess the relationship with demographic details.

Study status

Not yet started.

Discussion

The follow-up of the OSMF patients is expected to be better using a smartphone application as compared to the regular OPD-based follow-up. Numerous studies on these applications have been carried out, and more than 40,000 mobile health applications are already accessible on several platforms. However, there isn’t enough research to prove that these mobile apps integrate theory and were created using a qualitative design process. However, as mobile health technologies advance, there is growing concerned about how mobile application performance is constrained by their usability, accuracy, and data privacy.¹¹^,¹³

Rêgo et al., 2022, undertook a study with the goal of creating and validating a tool for identifying oral cancer risk factors. To evaluate the probability of developing oral cancer, an application was created that included predictors of the disease.¹⁴ For 40 experts in oral diagnostics to evaluate the algorithm and test its usability and accessibility, simulated clinical scenarios were created. The oral cancer screening was efficient, had good sensitivity and usability, and may even help find early oral lesions.¹⁴

Chang et al., 2019 conducted a study to show the methodical development course and content of the oral self-care application. Behavioral diagnosis, intervention design, and oral self-care assessment are the three phases of the systematic development process for oral self-care assessment.¹⁵ Through skilled assessment of the beta and final versions of the application and serviceability testing of the final version by patients with periodontal disease, the produced oral self-care app was evaluated and found to have good usability. This study described a meticulous design procedure for creating a customized, evidence-based mobile application for oral self-care, which makes it a personalized application for enhancing oral health in individuals with periodontal disease.¹⁵

Interpretation

The OSMF self-examination awareness approach involves inspecting and palpating one’s oral mucosa or oral cavity periodically in order to become familiar with it and spot anomalies. The goal of OSMF examination awareness facilitation and intervention is to raise public knowledge. Educational activities significantly contribute to the advancement of information, convictions, and OSMF screening practice.¹³

Generalizability

The population that consumes betel nut and tobacco products is the main focus of the study. The consumption of betel nut and tobacco products is done by a vast number of the Indian population. It is not always feasible for the patients to visit a dental setup for maintaining the follow-up. The study will be helpful in the follow-up of OSMF patients more promptly.

Dissemination

The study will be published in PubMed, Scopus, and Web of Sciences journal.

Data availability

Underlying data

No data are associated with this article.

Reporting guidelines

Zenodo: SPIRIT checklist for ‘Comparative evaluation of efficacy of a smartphone application for oral submucous fibrosis (OSMF) self-examination in follow-up of the patients compared to routine Outpatient Department-based follow-up’. https://doi.org/10.5281/zenodo.7965059.¹⁶

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

Acknowledgements

I would like to thank my institute and my colleagues.

References

1. Gupta S, Jawanda MK: Oral submucous fibrosis: An overview of a challenging entity. Indian J. Dermatol. Venereol. Leprol. 2021 Oct 23; 87(6): 768–777. PubMed Abstract | Publisher Full Text
2. Sheshaprasad R, Pai A, Yaji A: Habit History in Oral Submucous Fibrosis: Have We Over Emphasized? Asian Pac. J. Cancer Prev. 2019; 20(2): 451–455. Publisher Full Text
3. Sharma SR, Chavan S, Karjodkar FR, et al.: Correlation of Clinical Features in Oral Submucous Fibrosis: A 9-Year Retrospective Study. Ethiop. J. Health Sci. 2022 Jan 1; 32(1).
4. Niaz K, Maqbool F, Khan F, et al.: Smokeless tobacco (paan and gutkha) consumption, prevalence, and contribution to oral cancer. Epidemiology and health.
5. Shah G, Chaturvedi P, Vaishampayan S: Arecanut as an emerging etiology of oral cancers in India. Indian J. Med. Paediatr. Oncol. 2012 Apr; 33(02): 71–79. Publisher Full Text
6. Ali FM, Aher V, Prasant MC, et al.: Oral submucous fibrosis: Comparing clinical grading with duration and frequency of habit among areca nut and its products chewers. J. Cancer Res. Ther. 2013 Jul 1; 9(3): 471–476. PubMed Abstract | Publisher Full Text
7. Shivakumar GC, Sahana S, Saha S: Prevalence and site distribution of oral mucosal lesions in patients attending outpatient clinics of Oxford Dental College, Bangalore. J. Indian Assoc. Public Health Dent. 2010 Jan 1; 8(15): 69. Publisher Full Text
8. Muthukrishnan A, Warnakulasuriya S: Oral health consequences of smokeless tobacco use. Indian J. Med. Res. 2018 Jul; 148(1): 35–40. PubMed Abstract | Publisher Full Text
9. Arakeri G, Thomas D, Aljabab AS, et al.: TFM classification and staging of oral submucous fibrosis: A new proposal. J. Oral Pathol. Med. 2018 Apr; 47(4): 403–409. PubMed Abstract | Publisher Full Text
10. Cheng AS, Liu X, Ng PH, et al.: Protocol: Breast cancer application protocol: a randomised controlled trial to evaluate a self-management app for breast cancer survivors. BMJ Open. 2020; 10(7): e034655. PubMed Abstract | Publisher Full Text | Free Full Text
11. Shrivastava SR, Shrivastava PS, Ramasamy J: Self breast examination: A tool for early diagnosis of breast cancer. Am. J. Public Health Res. 2013 Jun 22; 1(6): 135–139. Publisher Full Text
12. Heo J, Chun M, Lee KY, et al.: Effects of a smartphone application on breast self-examination: a feasibility study. Healthc. Inform. Res. 2013 Dec 31; 19(4): 250–260. Publisher Full Text
13. Nasution A, Yusuf A, Keng SL, et al.: Development of Mobile App for Breast Examination Awareness Using Health Belief Model: A Qualitative Study. Asian Pac. J. Cancer Prev. 2021 Oct; 22(10): 3151–3163. PubMed Abstract | Publisher Full Text | Free Full Text
14. Rêgo TJ, Lemos JV, Matos AP, et al.: Development and professional validation of an App to support Oral Cancer Screening. Braz. Dent. J. 2022 Dec 5; 33: 44–55. PubMed Abstract | Publisher Full Text | Free Full Text
15. Chang WJ, Lo SY, Kuo CL, et al.: Development of an intervention tool for precision oral self-care: Personalized and evidence-based practice for patients with periodontal disease. PLoS One. 2019 Nov 21; 14(11): e0225453. PubMed Abstract | Publisher Full Text | Free Full Text
16. Dadgal K, Mohod S: Comparative evaluation of the efficacy of a smartphone application for oral submucous fibrosis (OSMF) self-examination in follow-up of the patients compared to routine Out Patient Department based (OPD) follow-up. [Dataset]. Zenodo. 2023. Publisher Full Text

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Version 2

VERSION 2 PUBLISHED 08 Mar 2024

Author details Author details

¹ DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY, DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH, WARDHA, MAHARASHTRA, 442001, India

Komal Vilas Dadgal
Roles: Funding Acquisition, Investigation, Writing – Original Draft Preparation, Writing – Review & Editing

Swapnil C. Mohod
Roles: Conceptualization, Resources, Software, Supervision, Validation, Visualization

Vidya Lohe
Roles: Data Curation, Formal Analysis

Shraddha Patel
Roles: Methodology, Project Administration

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

Article Versions (2)

version 2

Revised

Published: 14 May 2025, 13:165

https://doi.org/10.12688/f1000research.133893.2

version 1

Published: 08 Mar 2024, 13:165

https://doi.org/10.12688/f1000research.133893.1

© 2024 Dadgal KV et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The author(s) is/are employees of the US Government and therefore domestic copyright protection in USA does not apply to this work. The work may be protected under the copyright laws of other jurisdictions when used in those jurisdictions.

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Dadgal KV, Mohod SC, Lohe V and Patel S. Comparative evaluation of efficacy of a smartphone application for oral submucous fibrosis (OSMF) self-examination in follow-up of the patients compared to routine Outpatient Department-based follow-up: a clinical interventional study [version 1; peer review: 1 approved with reservations, 1 not approved]. F1000Research 2024, 13:165 (https://doi.org/10.12688/f1000research.133893.1)

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Open Peer Review

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PUBLISHED 08 Mar 2024

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Reviewer Report 22 Jan 2025

Prasad Nalabothu, University of Basel, Basel, Switzerland

Not Approved

https://doi.org/10.5256/f1000research.146908.r359598

The protocol raises several important concerns. One important issue is the lack of clarity about whether medical management or clinical interventions will be part of the follow-up process. This information is critical to assessing the effectiveness of the smartphone application for patients with OSMF. In addition, the protocol doesn't provide adequate information on how participants' privacy will be protected, particularly with regard to the protection of their personal health data. This is a critical issue in mobile health research. The study also lacks a clear definition of how the application will affect patient outcomes, leaving questions about its practical relevance unanswered. The sample size calculation is overly complicated and difficult to verify. The study also does not include a well-defined timeline or feasibility analysis for the phases of the study, in particular how the application will be modified based on user feedback. Without clear results, it is impossible to assess the effectiveness of the intervention being tested.
I recommend not indexing of the study protocol due to significant gaps in methodology, ethical considerations and feasibility.

Is the rationale for, and objectives of, the study clearly described?

No
Is the study design appropriate for the research question?

No
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

No

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: smart phone technologies. digital dentistry applications

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

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Author Response 14 May 2025

KOMAL DADGAL, DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY, DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH, WARDHA, 442001, India

14 May 2025

Author Response

The protocol raises several important concerns. One important issue is the lack of clarity about whether medical management or clinical interventions will be part of the follow-up process.
- Yes, ... Continue reading The protocol raises several important concerns. One important issue is the lack of clarity about whether medical management or clinical interventions will be part of the follow-up process.
- Yes, all the participants of Control (OPD-based follow-up) and intervention group (smartphone application-based follow-up) will be provided with medicinal treatment or clinical intervention. For both groups, patients will be recruited from outpatient department, the treatment protocol will be explained and medications will be prescribed at first visit.
In control group, as the patients report to the OPD for every follow-up, the participants are examined and medicinal treatment is provided to them depending on their grades or severity of OSMF. For intervention group, the follow-up information of the participants is recorded via smartphone application as well as participants will be in contact with the researcher through telephonic network. The medicinal intervention to the participants of intervention group will be done through telephonic communication.

This information is critical to assessing the effectiveness of the smartphone application for patients with OSMF. In addition, the protocol doesn't provide adequate information on how participants' privacy will be protected, particularly with regard to the protection of their personal health data. This is a critical issue in mobile health research.
- All the data of the participants in intervention group will reach the investigator through an account created in the same smartphone application for which only the investigator has access. No other person is able to login into the account in smartphone app of patient related data other than the investigator.

The study also lacks a clear definition of how the application will affect patient outcomes, leaving questions about its practical relevance unanswered.
-As OSMF is a chronic disease which needs regular and long-term follow-up and patient compliance due to its high malignant transformation rate, development of such smartphone application can be beneficial in maintaining the follow-up in the patients who are unable to report to OPD for follow-up.

The sample size calculation is overly complicated and difficult to verify.
The sample size formula has been edited and simplified in consultation with statistician.

The study also does not include a well-defined timeline or feasibility analysis for the phases of the study, in particular how the application will be modified based on user feedback. Without clear results, it is impossible to assess the effectiveness of the intervention being tested.
- Defined timeline of all the phases have been added to manuscript. The modifications in the smartphone application will be done according feedback on the patients understandability and usability regarding the self-assessment of any parameter of OSMF. To assess the effectiveness of the intervention being tested, the authenticity and reliability of the self-assessment finding will be cross-checked in 15 participants of the intervention group. These 15 patients will be called in OPD and the submitted data of these patients through smartphone app and observations on physical examination will be compared.
The protocol raises several important concerns. One important issue is the lack of clarity about whether medical management or clinical interventions will be part of the follow-up process.
- Yes, all the participants of Control (OPD-based follow-up) and intervention group (smartphone application-based follow-up) will be provided with medicinal treatment or clinical intervention. For both groups, patients will be recruited from outpatient department, the treatment protocol will be explained and medications will be prescribed at first visit.
In control group, as the patients report to the OPD for every follow-up, the participants are examined and medicinal treatment is provided to them depending on their grades or severity of OSMF. For intervention group, the follow-up information of the participants is recorded via smartphone application as well as participants will be in contact with the researcher through telephonic network. The medicinal intervention to the participants of intervention group will be done through telephonic communication.

This information is critical to assessing the effectiveness of the smartphone application for patients with OSMF. In addition, the protocol doesn't provide adequate information on how participants' privacy will be protected, particularly with regard to the protection of their personal health data. This is a critical issue in mobile health research.
- All the data of the participants in intervention group will reach the investigator through an account created in the same smartphone application for which only the investigator has access. No other person is able to login into the account in smartphone app of patient related data other than the investigator.

The study also lacks a clear definition of how the application will affect patient outcomes, leaving questions about its practical relevance unanswered.
-As OSMF is a chronic disease which needs regular and long-term follow-up and patient compliance due to its high malignant transformation rate, development of such smartphone application can be beneficial in maintaining the follow-up in the patients who are unable to report to OPD for follow-up.

The sample size calculation is overly complicated and difficult to verify.
The sample size formula has been edited and simplified in consultation with statistician.

The study also does not include a well-defined timeline or feasibility analysis for the phases of the study, in particular how the application will be modified based on user feedback. Without clear results, it is impossible to assess the effectiveness of the intervention being tested.
- Defined timeline of all the phases have been added to manuscript. The modifications in the smartphone application will be done according feedback on the patients understandability and usability regarding the self-assessment of any parameter of OSMF. To assess the effectiveness of the intervention being tested, the authenticity and reliability of the self-assessment finding will be cross-checked in 15 participants of the intervention group. These 15 patients will be called in OPD and the submitted data of these patients through smartphone app and observations on physical examination will be compared.
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Author Response 14 May 2025

KOMAL DADGAL, DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY, DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH, WARDHA, 442001, India

14 May 2025

Author Response

The protocol raises several important concerns. One important issue is the lack of clarity about whether medical management or clinical interventions will be part of the follow-up process.
- Yes, ... Continue reading The protocol raises several important concerns. One important issue is the lack of clarity about whether medical management or clinical interventions will be part of the follow-up process.
- Yes, all the participants of Control (OPD-based follow-up) and intervention group (smartphone application-based follow-up) will be provided with medicinal treatment or clinical intervention. For both groups, patients will be recruited from outpatient department, the treatment protocol will be explained and medications will be prescribed at first visit.
In control group, as the patients report to the OPD for every follow-up, the participants are examined and medicinal treatment is provided to them depending on their grades or severity of OSMF. For intervention group, the follow-up information of the participants is recorded via smartphone application as well as participants will be in contact with the researcher through telephonic network. The medicinal intervention to the participants of intervention group will be done through telephonic communication.

This information is critical to assessing the effectiveness of the smartphone application for patients with OSMF. In addition, the protocol doesn't provide adequate information on how participants' privacy will be protected, particularly with regard to the protection of their personal health data. This is a critical issue in mobile health research.
- All the data of the participants in intervention group will reach the investigator through an account created in the same smartphone application for which only the investigator has access. No other person is able to login into the account in smartphone app of patient related data other than the investigator.

The study also lacks a clear definition of how the application will affect patient outcomes, leaving questions about its practical relevance unanswered.
-As OSMF is a chronic disease which needs regular and long-term follow-up and patient compliance due to its high malignant transformation rate, development of such smartphone application can be beneficial in maintaining the follow-up in the patients who are unable to report to OPD for follow-up.

The sample size calculation is overly complicated and difficult to verify.
The sample size formula has been edited and simplified in consultation with statistician.

The study also does not include a well-defined timeline or feasibility analysis for the phases of the study, in particular how the application will be modified based on user feedback. Without clear results, it is impossible to assess the effectiveness of the intervention being tested.
- Defined timeline of all the phases have been added to manuscript. The modifications in the smartphone application will be done according feedback on the patients understandability and usability regarding the self-assessment of any parameter of OSMF. To assess the effectiveness of the intervention being tested, the authenticity and reliability of the self-assessment finding will be cross-checked in 15 participants of the intervention group. These 15 patients will be called in OPD and the submitted data of these patients through smartphone app and observations on physical examination will be compared.
The protocol raises several important concerns. One important issue is the lack of clarity about whether medical management or clinical interventions will be part of the follow-up process.
- Yes, all the participants of Control (OPD-based follow-up) and intervention group (smartphone application-based follow-up) will be provided with medicinal treatment or clinical intervention. For both groups, patients will be recruited from outpatient department, the treatment protocol will be explained and medications will be prescribed at first visit.
In control group, as the patients report to the OPD for every follow-up, the participants are examined and medicinal treatment is provided to them depending on their grades or severity of OSMF. For intervention group, the follow-up information of the participants is recorded via smartphone application as well as participants will be in contact with the researcher through telephonic network. The medicinal intervention to the participants of intervention group will be done through telephonic communication.

This information is critical to assessing the effectiveness of the smartphone application for patients with OSMF. In addition, the protocol doesn't provide adequate information on how participants' privacy will be protected, particularly with regard to the protection of their personal health data. This is a critical issue in mobile health research.
- All the data of the participants in intervention group will reach the investigator through an account created in the same smartphone application for which only the investigator has access. No other person is able to login into the account in smartphone app of patient related data other than the investigator.

The study also lacks a clear definition of how the application will affect patient outcomes, leaving questions about its practical relevance unanswered.
-As OSMF is a chronic disease which needs regular and long-term follow-up and patient compliance due to its high malignant transformation rate, development of such smartphone application can be beneficial in maintaining the follow-up in the patients who are unable to report to OPD for follow-up.

The sample size calculation is overly complicated and difficult to verify.
The sample size formula has been edited and simplified in consultation with statistician.

The study also does not include a well-defined timeline or feasibility analysis for the phases of the study, in particular how the application will be modified based on user feedback. Without clear results, it is impossible to assess the effectiveness of the intervention being tested.
- Defined timeline of all the phases have been added to manuscript. The modifications in the smartphone application will be done according feedback on the patients understandability and usability regarding the self-assessment of any parameter of OSMF. To assess the effectiveness of the intervention being tested, the authenticity and reliability of the self-assessment finding will be cross-checked in 15 participants of the intervention group. These 15 patients will be called in OPD and the submitted data of these patients through smartphone app and observations on physical examination will be compared.
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Reviewer Report 30 May 2024

Harshkant Gharote, Batterjee Medical College, Jeddah, Saudi Arabia

Approved with Reservations

https://doi.org/10.5256/f1000research.146908.r255951

The article is well written and elaborates materials and method.

Authors need to explain about follow up wherein only counselling and discontinuation of the habit will be included or any medical management will be employed? As chances ... Continue reading

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: As an Oral Physician I understand the epidemiology, clinical presentation and molecular pathogenesis of the disease studied in the present article.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Author Response 25 Jun 2024

KOMAL DADGAL, DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY, DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH, WARDHA, 442001, India

25 Jun 2024

Author Response

During the follow-up of the participants with OSMF, counseling, discontinuation of habit as well as medical intervention will be provided.
Competing Interests: The authors have no competing interests to declare.
During the follow-up of the participants with OSMF, counseling, discontinuation of habit as well as medical intervention will be provided.
During the follow-up of the participants with OSMF, counseling, discontinuation of habit as well as medical intervention will be provided.
Competing Interests: The authors have no competing interests to declare. Close
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Author Response 25 Jun 2024

KOMAL DADGAL, DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY, DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH, WARDHA, 442001, India

25 Jun 2024

Author Response

During the follow-up of the participants with OSMF, counseling, discontinuation of habit as well as medical intervention will be provided.
Competing Interests: The authors have no competing interests to declare.
During the follow-up of the participants with OSMF, counseling, discontinuation of habit as well as medical intervention will be provided.
During the follow-up of the participants with OSMF, counseling, discontinuation of habit as well as medical intervention will be provided.
Competing Interests: The authors have no competing interests to declare. Close
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Version 2

VERSION 2 PUBLISHED 08 Mar 2024

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Version 1 08 Mar 24	read	read

Harshkant Gharote, Batterjee Medical College, Jeddah, Saudi Arabia
Prasad Nalabothu, University of Basel, Basel, Switzerland
Supriya Kheur, Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidyapeeth, Pimpri, India

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2 Views

13 Jun 2025 | for Version 2

Supriya Kheur, Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune, India

2 Views Cite this report Responses(0)

Approved With Reservations

The concept of the study is very sound that the patients will be monitored using the smartphone. It can improve patient compliance, enable remote monitoring, and support early intervention, ultimately reducing the disease burden and preventing malignant transformation.
While India has seen rapid growth in mobile technology, recent surveys suggest:

The use of Smartphone still uneven in our population —higher in urban areas, lower in rural.
Elderly patients may have very limited digital literacy and those from lower socioeconomic strata may not own smartphones

The other important point is that the monitoring features includes only timely follow-up and educational features. There should have been a wider range of symptoms that can be monitored using the app.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Partly

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Oral potentially malignant disorders, Oral cancer, Stem cells, Biomaterial research

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3 Views

29 May 2025 | for Version 2

Harshkant Gharote, Batterjee Medical College, Jeddah, Saudi Arabia

3 Views Cite this report Responses(0)

Approved

The manuscript has been revised by the authors as per the comments and suggestions.

References

1. Campos LFXA, Cavalcante JP, Machado DP, Marçal E, et al.: Development and Evaluation of a Mobile Oral Health Application for Preschoolers.Telemed J E Health. 2019; 25 (6): 492-498 PubMed Abstract | Publisher Full Text

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

As an Oral Physician I understand the epidemiology, clinical presentation and molecular pathogenesis of the disease studied in the present article.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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21 Views

22 Jan 2025 | for Version 1

Prasad Nalabothu, University of Basel, Basel, Switzerland

21 Views Cite this report Responses(1)

Not Approved

The protocol raises several important concerns. One important issue is the lack of clarity about whether medical management or clinical interventions will be part of the follow-up process. This information is critical to assessing the effectiveness of the smartphone application for patients with OSMF. In addition, the protocol doesn't provide adequate information on how participants' privacy will be protected, particularly with regard to the protection of their personal health data. This is a critical issue in mobile health research. The study also lacks a clear definition of how the application will affect patient outcomes, leaving questions about its practical relevance unanswered. The sample size calculation is overly complicated and difficult to verify. The study also does not include a well-defined timeline or feasibility analysis for the phases of the study, in particular how the application will be modified based on user feedback. Without clear results, it is impossible to assess the effectiveness of the intervention being tested.
I recommend not indexing of the study protocol due to significant gaps in methodology, ethical considerations and feasibility.

Is the rationale for, and objectives of, the study clearly described?

No
Is the study design appropriate for the research question?

No
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

No

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

smart phone technologies. digital dentistry applications

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Author Response

14 May 2025

KOMAL DADGAL, DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY, DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH, WARDHA, 442001, India

The protocol raises several important concerns. One important issue is the lack of clarity about whether medical management or clinical interventions will be part of the follow-up process.
- Yes, all the participants of Control (OPD-based follow-up) and intervention group (smartphone application-based follow-up) will be provided with medicinal treatment or clinical intervention. For both groups, patients will be recruited from outpatient department, the treatment protocol will be explained and medications will be prescribed at first visit.
In control group, as the patients report to the OPD for every follow-up, the participants are examined and medicinal treatment is provided to them depending on their grades or severity of OSMF. For intervention group, the follow-up information of the participants is recorded via smartphone application as well as participants will be in contact with the researcher through telephonic network. The medicinal intervention to the participants of intervention group will be done through telephonic communication.

This information is critical to assessing the effectiveness of the smartphone application for patients with OSMF. In addition, the protocol doesn't provide adequate information on how participants' privacy will be protected, particularly with regard to the protection of their personal health data. This is a critical issue in mobile health research.
- All the data of the participants in intervention group will reach the investigator through an account created in the same smartphone application for which only the investigator has access. No other person is able to login into the account in smartphone app of patient related data other than the investigator.

The study also lacks a clear definition of how the application will affect patient outcomes, leaving questions about its practical relevance unanswered.
-As OSMF is a chronic disease which needs regular and long-term follow-up and patient compliance due to its high malignant transformation rate, development of such smartphone application can be beneficial in maintaining the follow-up in the patients who are unable to report to OPD for follow-up.

The sample size calculation is overly complicated and difficult to verify.
The sample size formula has been edited and simplified in consultation with statistician.

The study also does not include a well-defined timeline or feasibility analysis for the phases of the study, in particular how the application will be modified based on user feedback. Without clear results, it is impossible to assess the effectiveness of the intervention being tested.
- Defined timeline of all the phases have been added to manuscript. The modifications in the smartphone application will be done according feedback on the patients understandability and usability regarding the self-assessment of any parameter of OSMF. To assess the effectiveness of the intervention being tested, the authenticity and reliability of the self-assessment finding will be cross-checked in 15 participants of the intervention group. These 15 patients will be called in OPD and the submitted data of these patients through smartphone app and observations on physical examination will be compared.

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Reviewer Report

19 Views

30 May 2024 | for Version 1

Harshkant Gharote, Batterjee Medical College, Jeddah, Saudi Arabia

19 Views Cite this report Responses(1)

Approved With Reservations

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

As an Oral Physician I understand the epidemiology, clinical presentation and molecular pathogenesis of the disease studied in the present article.

Respond to this report

Responses (1)

Alongside their report, reviewers assign a status to the article:

Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions

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[10] 10. Cheng AS, Liu X, Ng PH, et al.: Protocol: Breast cancer application protocol: a randomised controlled trial to evaluate a self-management app for breast cancer survivors. BMJ Open. 2020; 10(7): e034655. PubMed Abstract | Publisher Full Text | Free Full Text

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[13] 13. Nasution A, Yusuf A, Keng SL, et al.: Development of Mobile App for Breast Examination Awareness Using Health Belief Model: A Qualitative Study. Asian Pac. J. Cancer Prev. 2021 Oct; 22(10): 3151–3163. PubMed Abstract | Publisher Full Text | Free Full Text

[14] 14. Rêgo TJ, Lemos JV, Matos AP, et al.: Development and professional validation of an App to support Oral Cancer Screening. Braz. Dent. J. 2022 Dec 5; 33: 44–55. PubMed Abstract | Publisher Full Text | Free Full Text

[15] 15. Chang WJ, Lo SY, Kuo CL, et al.: Development of an intervention tool for precision oral self-care: Personalized and evidence-based practice for patients with periodontal disease. PLoS One. 2019 Nov 21; 14(11): e0225453. PubMed Abstract | Publisher Full Text | Free Full Text

[16] 16. Dadgal K, Mohod S: Comparative evaluation of the efficacy of a smartphone application for oral submucous fibrosis (OSMF) self-examination in follow-up of the patients compared to routine Out Patient Department based (OPD) follow-up. [Dataset]. Zenodo. 2023. Publisher Full Text

Comparative evaluation of efficacy of a smartphone application for oral submucous fibrosis (OSMF) self-examination in follow-up of the patients compared to routine Outpatient Department-based follow-up: a clinical interventional study

Abstract

Keywords

Introduction

Background

Prevalence

Objectives

Methods

Ethical considerations

Study setting

Eligibility criteria

Intervention

Outcomes

Participant timeline

Sample size

Result

Recruitment

Allocation

Blinding

Phases

Data collection

Data management

Statistical analysis

Study status

Discussion

Interpretation

Generalizability

Dissemination

Data availability

Underlying data

Reporting guidelines

Acknowledgements

References

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