426471 alAsia-Pacific Journal of Public Health
APHXXX10.1177/1010539511426471Mehrotra et
Development and Validation of a Questionnaire to Evaluate Association of Tobacco Abuse With Oral Submucous Fibrosis
Asia-Pacific Journal of Public Health XX(X) 1–11 © 2011 APJPH Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/1010539511426471 http://aph.sagepub.com
Divya Mehrotra, MDS1, Girdhar Gopal Agarwal, PhD2, Sumit Kumar, MPH1, Anand Shukla, MDS1, and Akash Asthana, MSc2 Abstract Objective. Development of a reliable questionnaire to quantify habit of substance abuse with development of oral submucous fibrosis. Materials and methods. The questionnaire, substance abuse and precancer evaluation (SAPE) tool, was designed to assess the association of the habit of substance abuse with development of oral submucous fibrosis, a precancerous condition and various physical, social, psychological factors. Health professionals confirmed the content validity. Face validity was established by a participant focus group. The questionnaire was applied to 1100 participants with or without habit of substance abuse. Results. A total of 52 validated items were applied to the participants. Principal component analysis yielded 8 components having eigenvalues ≥2.0. Reliability was obtained by Cronbach’s α. The validity was measured by computing product–moment correlation coefficient between the diagnosis and the scores on the selected components. Conclusions. Preliminary reliability and validity of the SAPE tool has been demonstrated although more extensive testing is suggested. Keywords validation, tobacco, oral submucous fibrosis, questionnaire The World Health Organization defines substance abuse as harmful or hazardous use of psychoactive substances, including tobacco in smoking or smokeless forms, areca nut, betel quid, alcohol, marijuana, and ganja. Dependence syndrome is a cluster of behavioral, cognitive, and physiological phenomena, which usually develops with repeated substance use, strong desire to consume, and difficulties in controlling its use. Because of the harmful consequences, higher priority is given to prevention of substance abuse. Among the abuse substances, areca nut and tobacco continue to cause the maximum health damage. 1
Chhatrapati Shahuji Maharaj Medical University, Lucknow, India Lucknow University, Lucknow, India
2
Corresponding Author: Divya Mehrotra, Department of Oral and Maxillofacial Surgery, Chhatrapati Shahuji Maharaj Medical University, Chowk, Lucknow 226003, India Email:
[email protected]
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Oral submucous fibrosis (OSMF) is considered as a premalignant condition of the oral cavity and is associated with areca nut chewing.1 It is an insidious crippling condition affecting the lips, palate, cheek, tongue, oropharynx, and rarely, larynx.2 The disease is characterized by vesiculation, ulceration, blanching, stiffness of the oral mucosa, trismus, burning sensation in mouth, depapillation, hypomobility of the soft palate and tongue, ankyloglossia, impairment of taste sensation and occasionally, mild hearing loss due to blockage of Eustachian tube.3 Worldwide, estimates of OSMF indicate 2.5 million people to be affected, with most cases concentrated in the Indian subcontinent, especially southern India.4 Migration of endemic betel quid chewers having areca nut as the main constituent along with tobacco, betel leaf, and flavoring agents has also made it a public health issue in many parts of the world, including the United Kingdom, South Africa, and many Southeast Asian countries. The cause of this disease is still obscure although various studies have suggested a multifactorial origin with a high incidence of the disease in association with consumption of areca nut (fruit of areca catechu palm, also known as supari).5-9 There is some evidence to suggest that the disease may be related to peculiar dietary component like chilies (capsaicin), strong irritating spice commonly used in India, another causative factor may be vitamin B deficiency. A variety of other etiological factors include hypersensitivity, autoimmunity, genetic predisposition,10,11 and malnutrition.12 OSMF may be a mucosal change secondary to chronic iron deficiency with some authors calling it an Asian analogue of sideropenic dysphagia.13 In addition to tobacco and areca nut abuse, reduced intake of specific nutrients may have a role in the development of oral precancerous lesions. Many surveys14 have been conducted using questionnaires, containing sections on demographic data, use of smoking or smokeless forms of tobacco, attitudes of participant toward tobacco abuse, knowledge of tobacco hazards, exposures to environmental tobacco smoke, media advertising, cultural and social aspects15 of tobacco abuse,16,17 and psychological behavior,18,19 but none is available as a validated and reliable tool to find association with precancerous condition. This questionnaire, therefore, has been developed and validated to analyze the relative risk factors (substance abuse) for the occurrence of OSMF and may be used worldwide for epidemiological studies.
Research Design and Methods The study sample included 1100 participants, examined either at our outpatient department or at the oral health checkup camps organized within the period 2007-2008 at various rural and urban localities in Lucknow. The participants were enrolled in this study only after obtaining informed consent. The questionnaire was designed to interview the participants and obtain information regarding their habit of substance abuse along with their demographic data, various factors related to the physical, psychological dependence of the participants toward the habit, and assessment of disease outcome through clinical oral examination. The purpose of the questionnaire was to analyze the relative risk factors (substance abuse) for the occurrence of OSMF.
Results A total of 1100 participants were included in the study. Table 1 shows the sociodemographic profile of the participants included in the study. The data are represented in the cross-tabulation form showing details about age, gender, religion, marital status, domiciliary belonging, and socioeconomic status of the participants using the Kuppuswamy socioeconomic status scale.
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Mehrotra et al. Table 1. Agewise Sociodemographic Details of the Respondents Age in Years; n (%) Variable Gender Male Female Religion Hindu Muslim Sikh Christian Others Marital status Unmarried Married Divorced Widowed Domicile Rural Urban Socioeconomic status Lower Upper lower Lower middle Upper middle Upper
65
281 (28.90) 32 (25.77)
294 (30.24) 36 (28.87)
218 (22.45) 26 (20.62)
115 (11.83) 17 (13.40)
46 (4.70) 14 (11.34)
18 (1.88) 0 (0.00)
266 (29.28) 44 (24.72) 0 (0.00) 1 (20.00) 0 (0.00)
255 (28.07) 54 (30.34) 0 (0.00) 2 (40.00) 1 (25.00)
207 (22.76) 41 (23.03) 0 (0.00) 2 (40.00) 2 (50.00)
121 (13.26) 20 (11.24) 1 (100.00) 0 (0.00) 1 (25.00)
45(4.97) 16 (8.99) 0 (0.00) 0 (0.00) 0 (0.00)
15 (1.66) 3 (1.69) 0 (0.00) 0 (0.00) 0 (0.00)
137 (43.42) 173 (22.01) 0 (0.00) 4 (57.14)
68 (21.38) 247 (31.38) 1 (100.00) 1 (14.29)
52 (16.45) 203 (25.78) 0 (0.00) 0 (0.00)
36 (11.51) 106 (13.54) 0 (0.00) 1 (14.29)
18 (5.59) 44 (5.60) 0 (0.00) 1 (14.29)
5 (1.64) 13 (1.69) 0 (0.00) 0 (0.00)
219 (30.85) 95 (24.42)
197 (27.78) 119 (30.33)
158 (22.22) 95 (24.42)
83 (11.70) 58 (14.91)
38 (5.41) 20 (5.14)
15 (2.05) 3 (0.77)
0 (0.00) 7 (14.00) 39 (26.35) 242 (30.39) 25 (24.27)
1 (50.00) 15 (30.00) 47 (31.76) 220 (27.62) 30 (29.13)
1 (50.00) 14 (28.00) 37 (25.00) 174 (21.94) 25 (24.27)
0 (0.00) 8 (16.00) 16 (10.81) 99 (12.48) 19 (18.45)
0 (0.00) 6 (12.00) 8 (5.41) 44 (5.55) 3 (2.91)
0 (0.00) 0 (0.00) 1 (0.68) 16 (2.02) 1 (0.97)
This information was collected in section I (Demographic profile of the participant) in the questionnaire. The prevalence of various risk factors is presented in Table 2, where areca nut (supari; 51.43%) was the most consumed product. Table 3 shows prevalence of subjects diagnosed with OSMF by demographic variables. It clearly demonstrates that the highest prevalence of OSMF was in the age group 2.0) were selected for extraction. The component structure was rotated using varimax rotation. The items having the component loading 0.4 were selected for the final questionnaire. Scree plot20 was used to identify the most important component. To assess the construct validity, product–moment correlations were computed between diagnosis and selected components. The scores obtained for each of the participant were analyzed using principal component analysis and varimax rotation. The scree plot (Figure 1) suggested a plausible break at the eighth component. From the remaining 64 questions, 5 questions were dropped from the multivariate analysis as there was no response to the question. The response of participants on 59 items was used as their scores, and 8 factors were extracted accounting for 72.68% of total variance (Tables 4 and 5). The third section of the questionnaire was excluded from the analysis as it was used for the identification of OSMF in the subjects. The reliability of selected components was obtained using Cronbach’s α19 (Table 6).
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Table 2. Prevalence of Various Risk Factors Products Sada pan* Not consuming Consuming Sada pan masala** Not consuming Consuming Supari (areca nut) Not consuming Consuming Tobacco pan masala*** Not consuming Consuming Tobacco pan***** Not consuming Consuming Khaini/Mainpuri/Surti****** Not consuming Consuming Gul/tobacco powder****** Not consuming Consuming Cigarette******* Not consuming Consuming Bidi******* Not consuming Consuming
Total No. of Persons
Prevalence (%)
1062 37
11.86 32.43
1044 55
10.54 50.91
1064 35
11.28 51.43
861 238
8.25 28.15
978 121
10.53 28.93
1002 97
11.68 21.65
1068 31
12.08 29.03
1022 77
11.06 32.47
1053 46
11.78 30.43
* betel leaf, slaked lime, catechu, areca nut, cloves. **areca nut, slaked lime, catechu and condiments. ***Tobacco with betel leaf, slaked lime, catechu, areca nut, cloves. ****Tabacco with areca nut, slaked lime, catechu and condiments. *****smokeless forms of tobacco. ****** smoking tobacco.
Discussion To meet the need for a multidimensional diagnostic instrument in the field of substance abuse and occurrence of oral precancer, with special reference to OSMF, a well-structured interviewbased tool was designed and tested for reliability and validity. The questionnaire designed was an attempt to have a comprehensive and fully standardized tool to assess habit of substance abuse and oral precancer. A thorough review of the various studies already conducted in various parts of the world through structured, semistructured, or nonstructured interview schedule or questionnaires were taken into account for item selection of this tool and found relevant for recording the various aspects of the substance abuse and oral precancer. Global Youth Tobacco Survey14,21-24 contained an 85-item questionnaire, subdivided into several different sections on demographic data, use of both smoking and nonsmoking forms of tobacco, attitude toward tobacco use, knowledge of tobacco hazards, exposure to environmental tobacco smoke, school
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Mehrotra et al. Table 3. Prevalence of Subjects Diagnosed with Oral Submucous Fibrosis by Demographic Variables Variable Gender Male Female Religion Hindu Muslim Sikh Christian Others Marital status vUnmarried Married Divorced Widowed Domicile Rural Urban Socioeconomic status Lower Upper lower Lower middle Upper middle Upper Age (years) 65
Prevalence (%) 13.25 15.46 10.92 21.79 0.00 0.00 0.00 14.43 11.82 0.00 14.29 11.39 14.83 0.00 12.00 12.24 13.32 7.69 15.38 15.11 10.36 5.63 9.84 11.11
curriculum, media advertising, and 14 other variables, but it did not attempt to focus on disease outcome. Questionnaire in the manual for tobacco cessation focused on stimulation, handling, pleasure, relaxation/tension reduction, craving, and habit of tobacco.14,17 Stoffuffer et al25 discussed measurement of tobacco abuse and prediction, whereas the World Health Organization report26 focused on implementing smoke-free environments for healthy living. Our questionnaire passed through 3 stages: item generation, validation, and finalization. An expert panel of oral health care professional identified following 3 domains to record the information about the participant, habit of substance abuse, and its outcome in order to prepare a comprehensive set of items for the questionnaire, the substance abuse and precancer evaluation (SAPE) tool. Section I contained demographic data, which included domiciliary status and socioeconomic status of the participant along with the basic information, namely, name, age, gender, number of family members, education level, and contact information of the participant. As there is significant difference in the education level, health care facilities, and awareness levels among the 2 population types (rural and urban) in India, people residing in villages were referred as rural and
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Figure 1. Scree plot of the components obtained by principal component analysis
Table 4. Extraction of Component Component
Eigenvalue
Extraction
Cumulative Extraction
1 2 3 4 5 6 7
38.007 22.097 14.096 11.516 6.050 5.901 4.233
26.066 15.154 9.667 7.898 4.149 4.047 2.903
26.066 41.220 50.887 58.785 62.934 66.981 69.884
8
4.075
2.795
72.679
those living in cities were recorded as urban in their domiciliary status. Socioeconomic profile was recorded using the Kuppuswamy scale, based on education, occupation, and income of family head, and measured as upper, upper middle, lower middle, upper lower, and lower socioeconomic status.27 Section II contained history of substance abuse, wherein sada pan masala, tobacco,28 gutkha, betel quid, alcohol, marijuana, or any other substance was identified as the substance abused. Quantity, duration, frequency of abuse, factors related to urge, and age for start of habit were recorded and information was obtained on awareness29 of the participant on the consequences related to oral precancer/cancer development with the substance abuse. Section III included oral health examination—questions pertaining to the diagnosis of OSMF.
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Mehrotra et al. Table 5. Component Loadings Component Loading Items Description Component 1 Consumption of nonvegetarian food Duration of nonvegetarian food Consumption of spicy food Duration of spicy food Tobacco pan masala Duration tobacco pan masala Consumption of cigarette Component 2 Consumption of supari Duration of supari Consumption of gul Duration of gul Consumption of khaini Duration of khaini Consumption of tobacco pan Duration of tobacco pan Using time for tobacco product Component 3 Consumption of other tobacco products Duration of other tobacco products Maintain tobacco products during night Smoking by friends Component 4 Consumption of sada pan masala Duration of sada pan masala Consumption of alcohol Duration of alcohol Component 5 Consumption of bidi Duration of bidi Consumption of hookah Duration of hookah Component 6 Consumption of afeem* Duration of afeem Consumption of bhang* Duration of bhang Component 7 Consumption of sunghni tobacco** Duration of sunghni tobacco Consumption of other substance abuses Duration of other products Component 8 Consumption of ganja* Duration of ganja Consumption of sada pan Duration of sada pan *narcotics. **tobacco powder for smell.
1
2
3
4
5
6
7
8
0.708 0.763 0.647 0.693 0.476 0.476 0.421
0.129 0.072 0.005 0.043 0.257 0.342 0.115
0.183 0.144 0.169 0.267 0.239 0.055 0.403
0.125 0.018 0.248 0.132 0.12 0.024 0.295
0.111 0.054 0.038 0.001 0.26 0.16 0.2
0.018 0.058 0.186 0.161 0.131 0.102 0.059
0.11 0.099 0.043 0.033 0.073 0.1 0.101
0.066 0.05 0.029 0.038 0.122 0.062 0.09
0.087 0.127 0.103 0.082 0.176 0.193 0.088 0.101 0.243
0.619 0.631 0.551 0.484 0.53 0.536 0.529 0.484 0.418
0.034 0.002 0.152 0.127 0.206 0.221 0.366 0.407 0.094
0.03 0.092 0.251 0.29 0.342 0.381 0.169 0.152 0.092
0.235 0.226 0.08 0.101 0.022 0.018 0.046 0.034 0.198
0.153 0.166 0.024 0.005 0.137 0.138 0.07 0.046 0.04
0.013 0.052 0.003 0.006 0.003 0.015 0.064 0.076 0.008
0.227 0.181 0.165 0.106 0.043 0.077 0.173 0.237 0.068
0.265 0.298 0.216 0.383
0.101 0.091 0.202 0.156
0.484 0.532 0.482 0.445
0.356 0.396 0.353 0.188
0.133 0.153 0.012 0.098
0.073 0.094 0.109 0.283
0.049 0.048 0.003 0.069
0.139 0.151 0.007 0.131
0.164 0.045 0.349 0.304
0.014 0.035 0.219 0.197
0.279 0.257 0.073 0.064
0.423 0.416 0.423 0.428
0.236 0.22 0.146 0.14
0.038 0.004 0.24 0.246
0.171 0.177 0.079 0.069
0.227 0.258 0.058 0.057
0.098 0.073 0.008 0.035
0.069 0.075 0.002 0.043
0.244 0.259 0.144 0.196
0.224 0.241 0.114 0.126
0.562 0.585 0.488 0.513
0.064 0.071 0.079 0.098
0.047 0.055 0.136 0.155
0.163 0.185 0.113 0.084
0.02 0.02 0.162 0.162
0.058 0.058 0.068 0.068
0.042 0.042 0.202 0.202
0.167 0.167 0.02 0.02
0.066 0.066 0.246 0.246
0.634 0.634 0.411 0.411
0.168 0.168 0.328 0.328
0.336 0.336 0.045 0.045
0.053 0.053 0.07
0.011 0.011 0.179
0.065 0.065 0.258
0.103 0.103 0.155
0.118 0.118 0.219
0.218 0.218 0.257
0.689 0.689 0.472
0.13 0.13 0.283
0.114
0.138
0.251
0.152
0.108
0.251
0.428
0.256
0.079 0.079 0.021 0.009
0.047 0.047 0.114 0.188
0.002 0.002 0.104 0.066
0.012 0.012 0.097 0.044
0.004 0.004 0.071 0.073
0.106 0.106 0.059 0.005
0.054 0.054 0.006 0.016
0.512 0.512 0.456 0.518
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Table 6. Reliability and Validity of Component Component
Reliability (Cronbach’s α)
Construct Validity
.727 .703 .707 .674 .637 .715 .684 .690
.71 .69 .63 .58 .65 .44 .48 .37
1 2 3 4 5 6 7 8
Item Generation
90 Items generated with literature search Content and face valida!on (15 Items reduced) 75 items on questionnaire
Item Validation
11 items on demographic variables
64 items on substance abuse
and
10 items on OSMF diagnosis
5 items dropped due to no response
reduction 59 Items on substance abuse Subject to multivariate analysis (Principal Component Analysis)
Item Finalization
8 principal components having 41 items on substance abuse retained
Figure 2. Flowchart explaining reduction of items on questionnaire Abbreviation: OSMF, oral submucous fibrosis.
Initially, the questionnaire included 90 items divided in 3 domains, but the final questionnaire included only 52 (11 items on demographic variables and 41 items on substance abuse) wellstructured/framed questions that were tested for face value, validity, and reliability (Figure 2) Oral health care professionals from King George Medical University reviewed the questionnaire to ensure relevance, to clarity of items, and to also assess the content validity. The questionnaire was reviewed by 2 separate panels, including oral maxillofacial surgeons, periodontists, oral pathologists, nurses, residents, and interns totaling 20 specialists in each panel. The same questionnaire was then reviewed at 3 reputed centers by oral maxillofacial surgeons from All India Institute of Medical Sciences, New Delhi; Sir Ziauddin Ahmed Dental College, Aligarh Muslim
Mehrotra et al.
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University, Aligarh; and SDM College of Dental Sciences, Dharwad, Karnataka for their expert opinion on the content of the questionnaire. Feedback from the experts advised few additions to be made, namely, cross-checking of duration, start age of substance abuse, and influence of religious leaders to help cease the habit of substance abuse. The expert panel confirmed that all areas pertinent to the habit of substance abuse and clinical diagnosis of OSMF were included in the questionnaire. A participant focus group study was conducted to establish the face validity of the questionnaire. The participants included patients visiting outpatient department of oral and maxillofacial surgery and those examined at dental check-up camps organized in various rural and urban localities of Lucknow city, northern India. Feedback from the participants was included in the questionnaire; a few questions were reframed to convert it in a more lucid language. Combined with the content validity, the face validity of the participant focus group addressed all the aspects of the substance abuse and OSMF. Overall, 15 items were reduced on the basis of content and face validation from the initial set of 90 items in the questionnaire. The 75-item questionnaire now consisted of 11 items on demographic variables, 64 items on substance abuse, and 10 items on OSMF diagnosis organized in 3 sections. The first section consisted of 11 questions to record the participant’s sociodemographic profile. It contained binary type questions (domicile area, gender), nominal questions (marital status, religion), Likert-type scale questions (education, occupation, and income), and age measured as a continuous variable. In the second section, 5 questions were dropped because of nonresponse, thereby decreasing the number of items from 64 to 59. Further 8 principal components having 41 items on substance abuse were retained to identify item of substance abuse, for example, pan, tobacco, type of tobacco, alcohol, and marijuana, and a record was made of its quantity, frequency, and duration. It was constructed using Likert-type scale responses. The responses for the daily consumption of tobacco products and substance abuse were scaled from “1” (not consuming) to “6” (more than 24 times). The weekly consumption of nonvegetarian and spicy food was scaled from “1” (not consuming) to “5” (more than 6 times). Duration of consumption for any product was scaled from “1” (1-5 months) to “7” (more than 15 years). The third section of the questionnaire consisted of 10 questions pertaining to the diagnosis of OSMF. The questionnaire was completed after oral examination of the participant by the dental surgeon. The details of the components retained on the questionnaire with component labeling are shown in Table 5. The reliability and validity of the different components generated through principal component analysis are defined in Table 6. The reliability was maximum for the component 1 (value = .727) and minimum for the component 5 (value = .634). For the scores computed from items, grouped by principal component analysis, the reliabilities obtained were acceptable. The validity of the component ranged from the .71 (for component 1) to .37 (for component 8). This shows that the component 1 was highly correlated with the disease whereas component 8 had only a slight correlation with the disease. The finalized SAPE tool with 52 questions (11 in the first section and 41 in the second section) was found to be reliable and valid for the assessment of the habit of substance abuse and its relationship with OSMF.
Conclusion This questionnaire for SAPE was developed as a tool to quantify the habit of substance abuse and occurrence of OSMF. The tool evaluated the social and demographic factors of the participant, habit of substance abuse, various psychological factors associated with the habit, and dependence of the participant to the deleterious habit. This tool also assessed the awareness of the participant for the etiological factors of oral precancer and cancer. It provided information
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on various precancer lesions and conditions, with special reference to OSMF. The SAPE tool recorded the signs and symptoms that were significant for making the diagnosis of oral precancer, especially OSMF. The SAPE tool of 52 questions was found to be reliable and valid for the assessment of the habit of substance abuse and its relationship with OSMF. Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the authorship and/or publication of this article.
Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article:
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