|Year : 2022 | Volume
| Issue : 1 | Page : 55-61
Development and validation of a novel Middle childhood oral health impact scale (MCOHIS)
Sharath Asokan1, PR Geetha Priya1, Sudhandra Viswanath1, Shyam Sivasamy2, S Nambi Natchiyar1
1 Department of Pediatric and Preventive Dentistry, KSR Institute of Dental Science and Research, Tiruchengode, Tamil Nadu, India
2 Department of Public Health Dentistry, Meenakshi Academy of Higher Education and Research, Chennai, Tamil Nadu, India
|Date of Submission||23-Nov-2021|
|Date of Decision||24-Dec-2021|
|Date of Acceptance||22-Jan-2022|
|Date of Web Publication||13-Apr-2022|
Dr. Sharath Asokan
Department of Pediatric and Preventive Dentistry, KSR Institute of Dental Science and Research, Tiruchengode - 637 215, Tamil Nadu
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Purpose: The study was planned to develop and validate a novel middle childhood oral health impact scale (MCOHIS) for 6- to 9-year-old children in India. Methodology: A cross-sectional study design was employed to develop and validate MCOHIS in the sequential phases. A panel of ten pediatric dentists evaluated a pool of 36 items corresponding to the oral health-related quality of life (OHRQoL) of children. MCOHIS with 20 items under five domains was formulated and content validation was done. Cohen's kappa statistics was employed to measure the concordance between the child's self-report and the caregiver's proxy report. Concurrent validation was done among 130 participants from 13 districts of Tamil Nadu state, India. Discriminant validity was checked among another sample of 60 participants. Internal consistency and test-retest reliability of MCOHIS were assessed using Cronbach's alpha and Kappa statistics respectively. Results: MCOHIS had adequate content validation with Scale Level Content Validity Index / Average score of 0.94 for relevance. There was a statistically significant inter-rater reliability observed between the child's self-report and caregivers' proxy report in all items with a moderate to substantial agreement. Concurrent validation showed a statistically significant positive correlation with a Rho value of 0.712. There was a statistically significant difference noted in overall discriminant validity (P < 0.001). Acceptable internal consistency reliability was observed with Cronbach's alpha value of 0.75. Test-retest reliability showed a high stability coefficient of 0.98. Conclusions: MCOHIS was found to be a valid and reliable age-specific tool for assessing the OHRQoL of Indian children aged 6–9 years.
Keywords: Health-related quality of life, middle childhood oral health impact scale, middle childhood, oral health, quality of life
|How to cite this article:|
Asokan S, Geetha Priya P R, Viswanath S, Sivasamy S, Natchiyar S N. Development and validation of a novel Middle childhood oral health impact scale (MCOHIS). J Indian Soc Pedod Prev Dent 2022;40:55-61
|How to cite this URL:|
Asokan S, Geetha Priya P R, Viswanath S, Sivasamy S, Natchiyar S N. Development and validation of a novel Middle childhood oral health impact scale (MCOHIS). J Indian Soc Pedod Prev Dent [serial online] 2022 [cited 2022 May 23];40:55-61. Available from: https://www.jisppd.com/text.asp?2022/40/1/55/343019
| Introduction|| |
Oral health-related quality of life (OHRQoL) is a multifaceted outcome measure used for subjective evaluation of an individual's oral health-related functional well-being, social well-being, and sense of self. The World Health Organization recognized it as an important and integral part of the Global Oral Health Program because of its emerging importance in clinical decision-making and research. OHRQoL measures used for children vary greatly from the scales used for adults. Children experience different oral health problems at different developmental stages. Hence, age-specific OHRQoL assessment is used to identify and examine the factors that are unique to that particular population.
Different tools used to measure children's OHRQoL include child perception questionnaire for children aged 6–14 years, child oral health impact profile for children aged 8–14 years, child oral impacts on daily performances assessed among 11–14-year-old children, Pediatric Oral Health-Related Quality of Life (POQL) employed for preschool and school-aged children, early childhood oral health impact scale and oral health-related early childhood quality of life targeted preschool children.,,,,, None of these scales were specifically designed for children in early mixed dentition, a period of transition when several malocclusion problems can occur. Children in this stage go through a wide range of oral/dental problems related to deleterious oral habits that in turn affect their functional, psychological, and social well-being. Furthermore, the perception of oral health greatly varies across the globe because of the different socio-cultural backgrounds in different parts of the world. Most of the existing scales assessing the OHRQoL were designed for the western population in which odontogenic infections in children seeking emergency medical care and hospitalization have not been commonly addressed. This warrants the need for modifications in the child OHRQoL tools based on the different socio-cultural characteristics.
OHRQoL scales in children below 6 years of age are predominantly proxy reports as children in this age group have limited cognitive development. Children above 8 years of age have a good understanding of Likert scales and comprehension of vocabulary. Hence self-reports are feasible and reliable among these children. However, children in the age group of 6–9 years are in the transition phase. They can express their difficulties and emotions, but they cannot understand the complex questions. Moreover, familial impact, an important aspect of OHRQoL, cannot be addressed by this group of children. This emphasizes the need for an ideal proxy tool that provides reliable data on OHRQoL of children aged 6–9 years. Hence, the present study was planned to develop and validate a novel proxy tool, the middle childhood oral health impact scale (MCOHIS) for 6- to 9-year-old children in India.
| Methodology|| |
The present study was carried out by the Department of Pediatric and Preventive Dentistry from January to June 2021. The protocol of this cross-sectional study was analyzed and approved by the Institutional Review Board and Institutional Ethics Committee of the institution. The development and validation of the scale were done in the following sequential phases.
Phase 1: Initial item pool
The items were generated based on the existing literature on the OHRQoL of children.,,, The factors related to the oral health of 6-to 9-year-old children suitable to the Indian scenario were also included. The initial item pool consisted of 36 items representing different domains corresponding to the overall well-being of the child. Each question was designed to rate the child's experience on a five-point Likert scale.
Phase 2: Item reduction
A panel of ten pediatric dentists from India who were experts in the field of pediatric dentistry analyzed the applicability and credibility of the questionnaire through focus group discussion. Item reduction was done by removing the repeated items to minimize the redundant information on a particular oral condition. On common consensus, the final MCOHIS questionnaire with 20 items was formulated. It included nine items on general/physical well-being, four items on functional well-being, two items each on social well-being and school experiences, and three items on family impact. The five-point Likert scale was reduced to a three-point Likert scale to minimize the extreme response bias. It included the options never, occasionally, and often. MCOHIS item was scored as 0 for never, 1 for occasionally, 2 for often. The total score ranges from 0 to 40.
Phase 3: Content validity
Content validation of the questionnaire was done by a panel of experts in the field of dentistry from different geographical regions of Tamil Nadu. They were asked to rate each item on a four-point Likert scale (1-strongly agree, 2-agree, 3-disagree, 4-strongly disagree) based on its relevance and adequacy. Item-level content validity index (I-CVI) was calculated for each item. Scale-level content validity index based on average method (S-CVI/Ave) and based on universal agreement method (S-CVI/UA) were assessed. I-CVI score >0.79 suggests that the item is relevant. If the score is between 0.70 and 0.79, the item needs revision and if the score is below 0.70, the item should be eliminated. S-CVI/UA ≥0.8 and S-CVI/Ave ≥ 0.9 have excellent content validity. The questionnaire was modified based on the content validity scores and suggestions by the experts.
Phase 4: Linguistic validation
The content validated questionnaire was translated into the native language (Tamil) by an experienced professional translator. This forward translation was analyzed and reconciled for a better understanding of the target population. The reconciled version was back-translated to the source language (English) by a blinded professional. The content and quality of the new document were checked with the source document. The Tamil version of the validated questionnaire was named MCOHIS (Tam).
Phase 5: Inter-rater reliability
MCOHIS, the proxy report was filed by the parents or primary caregiver, to understand the child's OHRQoL. In order to check the concordance between the child and caregiver, the same questions were asked to both of them: (1) Self-report from the child (10 items) and (2) proxy report from the caregivers (10 items). The items pertaining to the child's difficulties and emotional experiences related to oral health were chosen from MCOHIS (20 items). An option “don't know” was also added to the choices given for each item to compare the reports of child and parent. The participants were randomly chosen from one-third of the total number of districts (38) in Tamil Nadu. It included 13 districts namely Chennai, Coimbatore, Erode, Karur, Namakkal, Perambalur, Salem, Sivaganga, Tiruchirapalli, Tirunelveli, Tirupur, Tenkasi, Virudhunagar. One hundred and thirty-eight parent-child pairs from various districts of Tamil Nadu filled the questionnaire through snowball sampling. Informed consent was obtained from all participants and the confidentiality of the participants was ensured according to the Declaration of Helsinki. Cohen's kappa statistics was employed to measure the inter-rater reliability for each item. The strength of agreement for the kappa coefficient was interpreted as follows: ≤0 = poor, 0.01–0.20 = slight, 0.21–0.40 = fair, 0.41–0.60 = moderate, 0.61–0.80 = substantial, and 0.81–1 = almost perfect.
Phase 6: Pilot test
A pilot test was conducted among 10 parents of children aged 6–9 years who visited the department of pediatric dentistry. Both the English and Tamil version of MCOHIS (Both MCOHIS and MCOHIS [Tam]) was administered to them to assess the understandability and ease of usage of the scale. No corrections or alterations were needed in both the questionnaire as it was well understood by the participants.
Phase 7: Concurrent validity
Ten parents each from above mentioned 13 districts in Tamil Nadu were included as the target population. A convenient sample of 130 participants who were willing to participate was included in this study. The MCOHIS was sent to the participants through the Google survey link. To check for concurrent validity, all the parents were asked to fill both the MCOHIS and the commonly used parent caregiver perception questionnaire (PCPQ). Reminders to fill the questionnaires were sent over a period of 2 weeks. Only one response per participant was considered for the analysis. The name, mobile number, and E-mail address of the participant were used to identify and remove the multiple entries from the same participant. The concurrent validity was analyzed using Spearman's rank-order correlation test. The spearman rho value ≥0.70 indicates a very strong relationship, 0.40–0.69– strong, 0.30–0.39– moderate, 0.20–0.29– weak, 0.01–0.19– negligible relationship. This is applicable for both positive and negative correlations. Post hoc power analysis for this phase of the study was estimated using G * power software (Version 184.108.40.206).
Phase 8: Discriminant validity
To check the discriminant validity of MCOHIS (Tam), 60 parents whose children had oral problems (n = 30) and no oral problems (n = 30) were included. Children had their clinical examination and their oral problems were recorded. It included dental caries (n = 15), malocclusion (n = 10) and gingival problems (n = 5). Mann–Whitney U test was used for analyzing all the five domains of the scale. Post hoc power analysis was done to estimate the power of the sample population included for discriminant validation.
Phase 9: Internal consistency reliability
It was assessed to ensure the general agreement between the domains of MCOHIS. The homogeneity among the items was measured using Cronbach's alpha. The value ranges from 0 to 1, with higher values indicating greater internal consistency.
Phase 10: Test-retest reliability
To measure the repeatability of the scale, test-retest reliability was done. A random sample of 30 children with similar oral health status was selected. The parents of these children were requested to repeat the MCOHIS (Tam) after a washout period of 2 weeks. The correlation between the participants' responses at different times was analyzed. Cohen's kappa statistics was used to check the test-retest reliability.
| Results|| |
The validation process resulted in 20 items that had adequate content coverage, improved clarity, and relevant information on the child's OHRQoL. The I-CVI scores for each item and S-CVI/Ave, S-CVI/UA scores for MCOHIS were presented in [Table 1].
There was a statistically significant inter-rater reliability observed between a child's self-report and caregivers' proxy report in all ten items with a moderate agreement. The item on “difficulty in brushing” had a substantial agreement. Items pertaining to functional and social well-being had more than 80% agreement [Table 2].
|Table 2: Concordance between child's self-report and caregiver's proxy report|
Click here to view
There was a statistically significant positive correlation observed between MCOHIS and PCPQ (P < 0.001). The Rho value of 0.712 suggested a very strong positive relationship between the two scales. Post hoc power analysis for this phase of the study showed that the sample had a power of 99%.
The overall assessment of discriminant validity showed that there was a statistically significant difference between the responses of parents of children with and without oral problems (P < 0.001). A statistically significant difference was observed in all the domains except the functional well-being domain [Table 3]. Post hoc power analysis for discriminant validation showed that the sample had an adequate power of 95%.
|Table 3: Discriminant validity of Middle Childhood Oral Health Impact Scale|
Click here to view
Internal consistency reliability
Acceptable internal consistency reliability was observed among different domains with Cronbach's alpha value of 0.75.
There was a statistically significant almost perfect test-retest reliability with a kappa value of 0.98 (P > 0.001).
| Discussion|| |
The development of a novel scale for assessing the OHRQoL of children in the middle childhood years is momentous. It is a crucial time for children to develop thinking and learning ability. It would be beneficial for the parents to assess how their child's oral health impacts various facets of life. This could further help them insist their children adapt to good oral health behaviors.
The process of the development of MCOHIS followed a multi-staged sequential approach of questionnaire development. The results from the content validity indicated that the items of MCOHIS were pertinent to measure OHRQoL of children in the specific age group. The questionnaire was tested among diverse backgrounds and different geographical areas in Tamil Nadu, India.
The MCOHIS was designed as a proxy measure for children as questions pertaining to family impact could be answered only by the caregivers. Moreover, a review of 53 health-related self-report measures for children up to 8 years of age reported that only 51% of the measures met minimum standards for internal consistency reliability and only 23% of the measures met standards for test-retest reliability. In addition, children's comprehension of medical/dental terms commonly used in questionnaires (e.g., nervous, sensitivity, and pain) tends to be limited in this age group. In the present study, there was a moderate to a substantial level of agreement noted between the child's and caregiver's reports. The results were compared with the health-related quality of life study by Raj et al. in Indian children. The option “don't know” was rarely selected by both the child and caregiver indicating that they were able to perceive the child's oral health and related problems well.
The concurrent validity of a new instrument is evaluated by comparing theoretical relationships of the new instrument with the other general, dimension-specific instrument that assesses similar constructs. PCPQ measures the OHRQoL of children aged 6–14 years through parent/caregiver's proxy report. PCPQ was chosen to check the concurrent validity of MCOHIS because it had a comparable measurement structure. The results showed a stronger correlation between the two scales and hence the concurrent validity of MCOHIS was proved.
In the present study, there was no significant difference noted in OHRQoL of children with and without oral problems based on their functional well-being domain. This might be because of the fact that children with and without caries were included in this study. Children with varying degrees of severity and pain associated with caries have to be studied to assess their effect on the child's functional well-being.
The majority of the population in rural areas of Tamil Nadu state are not familiar with the English language. Administering the conventional scales in English always poses a challenge to the researcher. MCOHIS (Tam) was specifically designed for this Tamil-speaking population who cannot understand, read or speak English. Tamil is an ancient Proto-Dravidian language that has been spoken from around the third millennium BC to the present era. This is the reason for the diverse spread of cultural origins of the Tamil population in different geographical areas. The Tamil language is spoken in India by the native people of Tamil Nadu state and union territory Puducherry. It is one of the official languages of India, Singapore, and Sri Lanka. It is also spoken by different Tamil communities in many countries such as Malaysia, South Africa, the United Kingdom, the United States, Canada, Australia, Fiji, and Mauritius. Hence, MCOHIS (Tam) could be employed to over 75 million Tamil-speaking ethnic populations across the world.
The present study included parents from various districts of Tamil Nadu, India to include the diverse Tamil ethnic population. However, other Tamil-speaking populations across the globe from diverse ethnic backgrounds could not be included. Further studies with diverse populations and parents of children with other oral health problems can be carried out.
| Conclusions|| |
Within the limitations of the study, the newly developed MCOHIS was found to be a valid and reliable tool for assessing the OHRQoL of Indian children aged 6–9 years. The study also emphasized the need for a novel age-specific OHRQoL tool for children in the early mixed dentition period or in their early middle childhood years. MCOHIS (Tam) promises to be a probable OHRQoL assessment tool for all Tamil-speaking populations across the globe.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Sischo L, Broder HL. Oral health-related quality of life: What, why, how, and future implications. J Dent Res 2011;90:1264-70.
Genderson MW, Sischo L, Markowitz K, Fine D, Broder HL. An overview of children's oral health-related quality of life assessment: From scale development to measuring outcomes. Caries Res 2013;47 Suppl 1:13-21.
Jokovic A, Locker D, Stephens M, Kenny D, Tompson B, Guyatt G. Validity and reliability of a questionnaire for measuring child oral-health-related quality of life. J Dent Res 2002;81:459-63.
Broder HL. Children's oral health-related quality of life. Community Dent Oral Epidemiol 2007;35 Suppl 1:5-7.
Gherunpong S, Tsakos G, Sheiham A. Developing and evaluating an oral health-related quality of life index for children; the CHILD-OIDP. Community Dent Health 2004;21:161-9.
Huntington NL, Spetter D, Jones JA, Rich SE, Garcia RI, Spiro A 3rd
. Development and validation of a measure of pediatric oral health-related quality of life: The POQL. J Public Health Dent 2011;71:185-93.
Pahel BT, Rozier RG, Slade GD. Parental perceptions of children's oral health: The Early Childhood Oral Health Impact Scale (ECOHIS). Health Qual Life Outcomes 2007;5:6.
Mathur VP, Dhillon JK, Logani A, Agarwal R. Development and validation of oral health-related early childhood quality of life tool for North Indian preschool children. Indian J Dent Res 2014;25:559-66.
] [Full text]
Dean JA. Managing the developing occlusion. In: Dean JA, editor. McDonald and Avery's Dentistry for the Child and Adolescent. 10th
ed. St. Louis, MO: Mosby/Elsevier; 2016. p. 415-78.
Matza LS, Patrick DL, Riley AW, Alexander JJ, Rajmil L, Pleil AM, et al.
Pediatric patient-reported outcome instruments for research to support medical product labeling: Report of the ISPOR PRO good research practices for the assessment of children and adolescents task force. Value Health 2013;16:461-79.
Rodrigues IB, Adachi JD, Beattie KA, MacDermid JC. Development and validation of a new tool to measure the facilitators, barriers and preferences to exercise in people with osteoporosis. BMC Musculoskelet Disord 2017;18:540.
Sim J, Wright CC. The kappa statistic in reliability studies: Use, interpretation, and sample size requirements. Phys Ther 2005;85:257-68.
Jokovic A, Locker D, Stephens M, Kenny D, Tompson B, Guyatt G. Measuring parental perceptions of child oral health-related quality of life. J Public Health Dent 2003;63:67-72.
Leclezio L, Jansen A, Whittemore VH, de Vries PJ. Pilot validation of the Tuberous sclerosis-Associated Neuropsychiatric Disorders (TAND) checklist. Pediatr Neurol 2015;52:16-24.
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods 2007;39:175-91.
Hajjar SE. Statistical analysis: Internal consistency reliability and construct validity. Int J Quant Qual Res Methods 2018;6:46-57.
Raj M, Sudhakar A, Roy R, Champaneri B, Joy TM, Kumar RK. Health-related quality of life in Indian children: A community-based cross-sectional survey. Indian J Med Res 2017;145:521-9.
] [Full text]
Stein B. Circulation and the Historical Geography of Tamil Country. J Asian Stud 1977;37:1-7.
Fernandez S, Clyne M. Tamil in Melbourne. J Multiling Multicult Dev 2007;28:169-87.
[Table 1], [Table 2], [Table 3]