Assessment of Pregnant Women’s Knowledge, Attitudes, and Habits Regarding Oral Health: Development and Validation of a Measurement Instrument

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

This study aimed to develop and rigorously validate an original standardized questionnaire designed to facilitate the reliable and objective assessment of knowledge, attitudes, and habits related to oral health in pregnancy.  Overall, the manuscript presents a relevant, well-written, and conceptually and methodologically sound study. Each phase has been rigorously developed. Below, I present an overview of each section, highlighting its strengths and potential considerations.

Abstract: Adequate

Keywords: Please review if these words are MeSH terms in order to obtain a better classification of this manuscript.

Introduction: Adequate for the study purposes

Methods:

• it could be useful an illustrative flowchart or figure explaining the study phases.
• The authors did not carry out the Confirmatory Factor Analysis (CFA), can the authors offer a justification for that decision?

Discussion: Adequate for the study purposes

Following these considerations, the manuscript can be accepted for publication in this journal.

Author Response

1. Comment:

Abstract: Adequate

Response:

We thank the Reviewer for the positive evaluation of the Abstract.

2. Comment:

Keywords: Please review if these words are MeSH terms to obtain a better classification of this manuscript.

Response:

We appreciate the Reviewer’s suggestion. We have aligned the keywords with MeSH recommendations and included 'Croatia' to emphasize the regional context of the study

In accordance with the MeSH system, we have removed the term 'COSMIN' and added 'Croatia' to improve the searchability of our article.

We have incorporated these changes into: Section: Keywords, Paragraph 1, Line 82

3. Comment:

Introduction: Adequate for the study purposes

Response:

We thank the Reviewer for the positive evaluation of the Introduction.

 4. Comment:

Methods:it could be useful an illustrative flowchart or figure explaining the study phases.

 Response:

We appreciate the Reviewer’s valuable suggestion. To improve the clarity and transparency of the methodological process, we have added an illustrative flowchart summarizing the main phases of the study.

 

This addition was incorporated into the Methods section to facilitate a clearer understanding of the sequential stages of instrument development and validation.

We have incorporated these changes into: Section2: Keywords, Paragraph 1, Line. 169-176

 5. Comment:

The authors did not carry out the Confirmatory Factor Analysis (CFA); can the authors offer a justification for that decision?

Response:

We appreciate the Reviewer’s important methodological question. The primary aim of the present study was to conduct the initial exploratory phase of instrument development and psychometric evaluation. In accordance with standard psychometric practice and recommendations, exploratory factor analysis (EFA) was first performed to identify a plausible latent structure within the newly developed instrument.

Confirmatory factor analysis (CFA) was intentionally not conducted at this stage for the following reasons:

Exploratory stage of development:

The KAOH Questionnaire represents a newly constructed instrument, and EFA was used as an initial step to explore the underlying factor structure before confirmatory testing.

Instrument refinement process:

Following the EFA, three additional theoretically motivated items were added to strengthen one factor (F6). Because these items were introduced after the exploratory analysis, conducting CFA within the same dataset would not provide an independent confirmation of the final structure.

Requirement for independent validation:

Methodologically, CFA is most appropriately performed on an independent sample to avoid capitalization on chance and to provide a genuine test of structural stability.

Accordingly, the manuscript has been revised to explicitly state that the factorial validity of the final 30-item version remains provisional and that confirmatory factor analysis on an independent sample represents the planned next step in the validation process.

A formal CFA is planned as part of a broader, multicenter study to ensure the generalizability of the measurement model

In accordance with the reviewers' suggestions, several changes have been made to:

 

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6. Comments:

Discussion: Adequate for the study purposes

Response:

We thank the Reviewer for the positive evaluation of the Discussion.

Reviewer 2 Report

Comments and Suggestions for Authors

In addition to addressing a pertinent public health issue, the study offers an intriguing attempt to create and validate a measurement tool for evaluating the oral health practices, attitudes, and knowledge of expectant mothers. The authors have put a lot of effort into creating instruments and conducting preliminary psychometric testing, and the creation of context-specific tools is beneficial.

Before the instrument can be deemed completely validated and prepared for use in various scientific or clinical contexts, a few methodological and interpretive errors in the manuscript must be addressed. Therefore, I recommend a substantial revision.

The primary areas of concern include the conceptual framing, psychometric validation processes, statistical justification, and interpretation of the findings. Even though the study offers preliminary evidence, a number of components needed for reliable instrument validation are still lacking or not sufficiently supported. Furthermore, some conclusions seem more robust than the supporting empirical data.

Important remarks:

The manuscript presents "The Theory of Planned Behaviour" as a conceptual basis, but it is not sufficiently clear how the theoretical constructs were operationalised in item development or factor interpretation. The linkage between theory, item generation, and factor structure should be clarified in a more systematic and transparent manner.

The study's external validity is significantly limited because it uses a convenience sample that was selected from a single geographic area. The implications for generalisability should be acknowledged more clearly in the manuscript, and generalisations about applicability outside of the study population should be avoided. It's also important to disclose data on participation rates and possible selection bias.

A significant methodological issue is that the exploratory factor analysis was performed on a prior version of the instrument, while new items were later added without comprehensive psychometric re-evaluation. This post hoc expansion of the scale requires confirmatory factor analysis to verify the final structure. Without such analysis, the factorial validity of the final instrument remains uncertain.

The validation is largely exploratory. Additional evidence of construct validity is needed, including stronger evaluation of convergent and discriminant validity. Criterion validity is asserted but weakly demonstrated. Measurement invariance across relevant demographic subgroups is not examined.

The regression model was not statistically significant and explained only a minimal proportion of variance, yet researchers superficially examined or theoretically interpreted this result. The implications for constructing relationships and predictive validity should be more critically discussed.

The exceptionally high test-retest reliability demands careful examination, taking into account possible methodological explanations like recall or response stability unrelated to construct measurement, as one factor only exhibits moderate internal consistency.

Given the exploratory nature of the analyses and the acknowledged need for additional validation (e.g., confirmatory factor analysis, longitudinal testing), the manuscript's presentation of the instrument as fully validated and prepared for widespread use seems premature. The conclusions ought to be more moderated and in line with the degree of empirical backing.

Although some limitations are acknowledged, their methodological implications are not fully explored. The cross-sectional design, self-report measures, regional sampling, and incomplete validation procedures should be discussed more explicitly and critically.

Explain the reasoning behind particular statistical decisions where presumptions are broken.

Report on hiring practices and response rates in greater detail.

Enhance uniformity in the reporting of thresholds and psychometric terminology.

Refine language when assertions of methodological superiority or novelty are made without supporting comparisons.

Author Response

Comments and Suggestions for Authors

In addition to addressing a pertinent public health issue, the study offers an intriguing attempt to create and validate a measurement tool for evaluating the oral health practices, attitudes, and knowledge of expectant mothers. The authors have put a lot of effort into creating instruments and conducting preliminary psychometric testing, and the creation of context-specific tools is beneficial.

Before the instrument can be deemed completely validated and prepared for use in various scientific or clinical contexts, a few methodological and interpretive errors in the manuscript must be addressed. Therefore, I recommend a substantial revision.

The primary areas of concern include the conceptual framing, psychometric validation processes, statistical justification, and interpretation of the findings. Even though the study offers preliminary evidence, a number of components needed for reliable instrument validation are still lacking or not sufficiently supported. Furthermore, some conclusions seem more robust than the supporting empirical data.

Response:

We sincerely thank the Reviewer for the detailed and constructive feedback. 

1. Comment:

The manuscript presents "The Theory of Planned Behaviour" as a conceptual basis, but it is not sufficiently clear how the theoretical constructs were operationalised in item development or factor interpretation. The linkage between theory, item generation, and factor structure should be clarified in a more systematic and transparent manner.

Response:

Thank you for this important comment. We clarified the Theory of Planned Behaviour (TPB) operationalisation in the Methods and Discussion by explicitly mapping the extracted factors to TPB constructs: F1 and F3 (attitudes), F2 and F4 (subjective norms), and F6 (perceived behavioural control). We also added a statement that this mapping was theoretically predefined during item development and should be interpreted as theory-informed rather than confirmatory, given the exploratory design. Finally, we clarified that the independence of the knowledge factor is consistent with TPB assumptions that information alone does not necessarily translate into behaviour.

In accordance with the reviewers' suggestions, several changes have been made to:

The section:	The paragraph:	Specific lines:	The pages:
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a)2 b) 2	1 2	169-175 176	4 5
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2. Comment:

The study's external validity is significantly limited because it uses a convenience sample that was selected from a single geographic area. The implications for generalisability should be acknowledged more clearly in the manuscript, and generalisations about applicability outside of the study population should be avoided. It's also important to disclose data on participation rates and possible selection bias.

Response:

We fully acknowledge that the external validity of the present study is limited by the use of a convenience sample recruited from a single geographic region (Primorje-Gorski Kotar County, Croatia). The primary aim of this study was instrument development and initial psychometric evaluation rather than population-level inference. As is common in early-stage psychometric development, such studies are typically conducted within accessible and contextually defined populations to establish preliminary structural validity and reliability.

 

Following the Reviewer’s suggestion, we revised the manuscript to clearly state that findings should be interpreted as preliminary and that generalization beyond the studied population should be approached with caution. Statements implying broader applicability were moderated, and the Limitations section now explicitly emphasizes the need for validation in geographically and culturally diverse samples.

Recruitment procedures are now described in greater detail. All primary gynecological practices in the county were invited, with participation dependent on voluntary agreement. We explicitly acknowledge that this may introduce selection bias and potentially underrepresent certain subgroups. Future studies are planned using multicenter or probabilistic sampling approaches to strengthen external validity and enable confirmatory testing.

In accordance with the reviewers' suggestions, several changes have been made to:

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2.1.	3	205-207	6
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3. Comment:

A significant methodological issue is that the exploratory factor analysis was performed on a prior version of the instrument, while new items were later added without a comprehensive psychometric re-evaluation. This post hoc expansion of the scale requires confirmatory factor analysis to verify the final structure. Without such analysis, the factorial validity of the final instrument remains uncertain.

Response:

We fully agree that the distinction between the exploratory phase of instrument development and the final expanded version of the questionnaire must be clearly articulated, and we appreciate the opportunity to clarify this aspect of our study.

As correctly observed, the exploratory factor analysis (EFA) was conducted on the 27-item core version of the instrument. The three additional items were introduced after completion of the EFA as part of the iterative instrument-development process, primarily to strengthen the conceptual coverage and internal consistency of Factor 6 (Fatigue, Nausea, and Oral Hygiene Discomfort), which demonstrated comparatively lower reliability and limited content breadth in the initial exploratory solution. The inclusion of these items was guided by theoretical considerations, expert consensus, and clinical relevance rather than post hoc statistical optimization or data-driven model fitting.

We acknowledge the Reviewer’s point that, because these items were added after the exploratory analysis, the factorial validity of the final 30-item version cannot be considered fully confirmed at this stage. In line with psychometric best practices, exploratory factor analysis represents an initial stage of scale development aimed at identifying a plausible latent structure, while confirmatory factor analysis (CFA) is required to test and confirm the stability of the finalized model in an independent sample. Our intention was therefore not to present the expanded version as definitively confirmed, but rather as a theoretically refined instrument requiring further confirmatory testing.

Following the Reviewer’s recommendation, we have revised the manuscript to explicitly state that the current study provides preliminary psychometric evidence for the factor structure, and that the factorial validity of the final 30-item instrument remains provisional until confirmed through CFA. We have also clarified that the post hoc item addition should be interpreted as part of an iterative refinement process, common in early-stage instrument development. To address this issue transparently, several revisions were implemented:

The Methods section now clearly differentiates between the 27-item EFA version and the final 30-item questionnaire.

The Results and Discussion sections explicitly acknowledge that the factorial structure of the expanded version has not yet undergone confirmatory testing.

The Limitations and Future Directions sections now state that confirmatory factor analysis (CFA), along with additional construct validation procedures, represents a planned next step in subsequent research.

We believe that these revisions improve the methodological transparency of the manuscript and more accurately position this work as an initial validation study within a broader ongoing process of instrument refinement and psychometric evaluation.

We thank the Reviewer again for highlighting this important point, which has significantly strengthened the clarity and rigor of our manuscript.

Importantly, we fully concur with the Reviewer that confirmatory testing is essential for establishing the final factorial validity of the instrument, and we view the present study as a necessary exploratory step that provides the empirical and theoretical foundation for this next phase of validation. The planned CFA on an independent sample will therefore represent a continuation of the same validation process rather than a corrective action, ensuring methodological continuity and psychometric adequacy.

In accordance with the reviewers' suggestions, several changes have been made to:

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4. Comment:

The validation is largely exploratory. Additional evidence of construct validity is needed, including a stronger evaluation of convergent and discriminant validity. Criterion validity is asserted but weakly demonstrated. Measurement invariance across relevant demographic subgroups is not examined.

Response:

We agree that the present validation represents an initial, predominantly exploratory phase of instrument development and that additional sources of validity evidence are required to fully establish the psychometric properties of the questionnaire.

The primary objective of this study was to develop the instrument and provide preliminary evidence of structural validity and reliability through exploratory factor analysis (EFA), internal consistency assessment, and test–retest reliability. Accordingly, the current validation should be interpreted as an initial step within a broader validation framework rather than as a complete psychometric evaluation. Following the Reviewer’s suggestion, we have revised the manuscript to more explicitly describe the exploratory nature of the present validation and to avoid implications that the instrument has undergone comprehensive validation at this stage.

Regarding construct validity, we acknowledge that convergent and discriminant validity were not formally tested in the present study. The observed factor structure provides preliminary evidence of conceptual differentiation among constructs; however, a stronger evaluation of construct validity will require confirmatory analyses and the inclusion of external theoretically related measures. We have therefore clarified in the revised manuscript that future studies will include confirmatory factor analysis (CFA) and additional construct-validation procedures specifically aimed at assessing convergent and discriminant validity.

Concerning criterion validity, we agree that the evidence provided in the current manuscript is limited. The correlations and regression analyses were exploratory in nature and were intended primarily to examine initial relationships between factors rather than to establish definitive preliminary relational evidence. To avoid overinterpretation, we have revised the wording in the manuscript to describe criterion-related evidence as preliminary and exploratory.

We also acknowledge that measurement invariance across relevant demographic subgroups was not assessed. Given the exploratory stage of instrument development and the sample size limitations, invariance testing was beyond the scope of the current study. Nevertheless, we fully agree that evaluating measurement invariance (e.g., across age groups, parity, educational level, or other relevant sociodemographic characteristics) represents an essential next step. This has now been explicitly added to the future research directions in the revised manuscript.

In summary, we have revised the manuscript to clearly position the current study as an initial psychometric validation and to explicitly state that further evidence of construct validity, preliminary relational evidence, and measurement invariance will be addressed in subsequent studies. We appreciate the Reviewer’s comment, which has helped us improve the methodological clarity and transparency of the manuscript.

Following the Reviewer’s suggestion, we have added the following clarification in the Discussion section:

The present study should be interpreted as an initial stage of instrument development, aimed primarily at establishing preliminary structural validity and reliability within a defined population. Although the obtained results provide encouraging psychometric evidence, comprehensive validation requires further confirmatory testing, including assessment of convergent and discriminant validity, criterion-related validity, and measurement invariance across relevant subgroups. Consequently, future studies using independent and more diverse samples will be essential to confirm the stability and generalizability of the proposed factor structure.

A formal CFA is planned as part of a broader, multicenter study to ensure the generalizability of the measurement model

In accordance with the reviewers' suggestions, several changes have been made to:

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 5. Comment:

The regression model was not statistically significant and explained only a minimal proportion of variance, yet researchers superficially examined or theoretically interpreted this result. The implications for constructing relationships and predictive validity should be more critically discussed.

Response:

We thank the Reviewer for this important comment. We agree that the interpretation of the regression analysis required a more critical and cautious discussion.

As noted, the regression model was not statistically significant and explained only a minimal proportion of variance in the Knowledge score (R² = .019). The analysis was exploratory and intended only to examine potential preliminary relationships between the identified factors and knowledge. The results indicate that the present model did not capture meaningful predictive associations within this sample.

Following the Reviewer’s suggestion, we revised the manuscript to avoid any implication of predictive validity or causal interpretation. The regression findings are now explicitly described as exploratory and hypothesis-generating. We further emphasize that oral health knowledge and related behaviors are likely influenced by additional motivational, contextual, and psychosocial variables not included in the current model.

Revisions were made in the Discussion section to (i) acknowledge the limited explanatory power of the model, (ii) provide a more critical interpretation of the findings, and (iii) avoid overinterpretation of relational or predictive implications. Future longitudinal studies with theoretically expanded models will be required to properly evaluate predictive validity.

In accordance with the reviewers' suggestions, several changes have been made to:

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6. Comments:

The exceptionally high test-retest reliability demands careful examination, taking into account possible methodological explanations like recall or response stability unrelated to construct measurement, as one factor only exhibits moderate internal consistency.

Response:

We agree that the exceptionally high test–retest coefficient requires cautious interpretation.

Although the analysis demonstrated very high temporal agreement over a two-week interval, we acknowledge that methodological factors may have contributed to this result, including the short retest interval, response recall, or response consistency unrelated to true construct stability. This is particularly relevant given that one factor demonstrated only moderate internal consistency.

Following the Reviewer’s suggestion, the Discussion section was revised to include a more cautious interpretation of these findings, explicitly noting that the short retest interval may have inflated stability estimates. We also added that future studies should consider longer retest intervals better to distinguish true construct stability from potential methodological influences.

In accordance with the reviewers' suggestions, several changes have been made to:

 

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7. Comment:

Given the exploratory nature of the analyses and the acknowledged need for additional validation (e.g., confirmatory factor analysis, longitudinal testing), the manuscript's presentation of the instrument as fully validated and prepared for widespread use seems premature. The conclusions ought to be more moderate and in line with the degree of empirical backing.

Response:

We agree that, given the exploratory nature of the present analyses and the need for further confirmatory work, the interpretation of the instrument’s validation status required more cautious framing.

The primary objective of this study was to develop the instrument and provide initial psychometric evidence, including exploratory structural validity, internal consistency, and test–retest reliability. We acknowledge that additional validation steps, such as confirmatory factor analysis, longitudinal assessment, and broader construct validation, are necessary before the instrument can be considered fully validated for widespread application.

Following the Reviewer’s suggestion, we have revised the manuscript to moderate the language throughout the Abstract, Discussion, and Conclusion sections. Specifically, statements implying that the instrument is “fully validated” or ready for broad implementation have been replaced with terminology reflecting its current stage of development (e.g., initial psychometric validation, preliminary evidence, or early-stage validation).

In addition, the conclusions have been revised to better align with the empirical evidence provided in this study. The manuscript now emphasizes that the instrument shows promising initial psychometric properties, while clearly stating that further confirmatory and longitudinal studies are required before broader generalization or widespread use can be recommended.

We appreciate the Reviewer’s comment, which has helped us improve the scientific precision and interpretative balance of the manuscript.

In accordance with the Reviewer’s suggestion, we have revised the Conclusion section and added the following clarifying sentence:

„The present study provides initial psychometric evidence supporting the proposed structure and reliability of the instrument; however, further confirmatory and longitudinal validation studies are required before broader implementation and generalization can be fully justified“.

 

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8. Comment:

Although some limitations are acknowledged, their methodological implications are not fully explored. The cross-sectional design, self-report measures, regional sampling, and incomplete validation procedures should be discussed more explicitly and critically.

Response:

We agree that the methodological implications of the study limitations require clearer and more critical discussion.

Following the Reviewer’s suggestion, we have revised the Limitations section to more explicitly address the methodological constraints of the study and their implications for the interpretation of the findings. Specifically, we now more clearly acknowledge that the cross-sectional design limits causal inference and prevents evaluation of temporal stability and responsiveness beyond the short retest interval. In addition, we have expanded the discussion of self-report methodology, emphasizing the potential influence of social desirability and response bias, despite the anonymity procedures used during data collection.

Furthermore, the manuscript now more explicitly discusses the implications of regional convenience sampling, noting that recruitment from a single geographic area may limit representativeness and external validity, and that the findings should therefore be interpreted as preliminary and context-specific.

We also clarified that the present study represents an initial stage of psychometric validation. While exploratory structural validity and reliability were assessed, we now explicitly acknowledge that additional validation procedures, including confirmatory factor analysis, stronger construct validity testing, and measurement invariance analyses, are necessary before broader generalization or widespread application can be justified.

These revisions were implemented to ensure a more critical and transparent discussion of methodological limitations and to better align the interpretation of results with the scope of the empirical evidence.

We appreciate the Reviewer’s comment, which has helped us strengthen the methodological clarity and scientific rigor of the manuscript.

In accordance with the Reviewer’s suggestion, we have revised the Limitation section and added the following clarifying sentence:

„These methodological limitations should be carefully considered when interpreting the findings, and the results should therefore be viewed as preliminary and primarily exploratory rather than definitive“.

In accordance with the reviewers' suggestions, several changes have been made to:

 

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9. Comment:

Explain the reasoning behind particular statistical decisions where presumptions are broken.

Response:

We thank the Reviewer for this important suggestion. We agree that the rationale for several statistical decisions required clearer explanation, particularly where standard parametric assumptions were not met.

In the revised manuscript, we added explicit justification for key analytic choices.

 Specifically:

• Non-normality: Because variables deviated from normal distribution (Kolmogorov–Smirnov tests, all p < .001), descriptive statistics are reported as median and interquartile range (IQR), and associations were examined using Spearman’s rank correlations.
• Factor analysis approach: The core items were measured using Likert-type responses; therefore, exploratory factor analysis was conducted using principal axis factoring, which is less sensitive to violations of normality. Factor retention was based on multiple criteria (eigenvalues, scree plot, and parallel analysis), and oblique (Promax) rotation was applied, given the expected correlations among latent constructs.
• Regression analysis: The regression model is now explicitly framed as exploratory and interpreted cautiously due to the non-significant model and minimal explained variance, without claims of predictive validity.

These revisions were incorporated to improve the transparency and methodological clarity of the statistical reporting.

In accordance with the reviewers' suggestions, several changes have been made to:

 

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10. Comment:

Report on hiring practices and response rates in greater detail.

Response:

We thank the Reviewer for this suggestion. The Methods section was revised to provide a clearer description of recruitment procedures and participation. Specifically, we clarified that all primary gynecological practices in Primorje-Gorski Kotar County were invited to participate, with inclusion dependent on the voluntary agreement of individual practices. We also added details on questionnaire distribution during routine prenatal visits and procedures used to ensure anonymity.

In addition, we now explicitly state that recruitment was based on convenience sampling and depended on both practice-level participation and individual consent, which may have introduced selection bias. This limitation is now more clearly discussed in the Limitations section.

In accordance with the reviewers' suggestions, several changes have been made to:

 

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Abstract	1	74-77	2
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11. Comment:

Enhance uniformity in the reporting of thresholds and psychometric terminology.

Response:

We thank the Reviewer for this valuable suggestion. The manuscript was revised to improve consistency in psychometric terminology and reporting thresholds. Terminology related to validity and reliability (e.g., structural validity, construct validity, internal consistency, and test–retest reliability) was standardized throughout the manuscript. Thresholds and interpretative criteria (e.g., Cronbach’s alpha ranges, significance levels, and factor loadings) are now reported uniformly across Methods, Results, and Discussion sections.

In addition, exploratory findings are consistently described as preliminary, and terminology implying confirmatory validation has been removed where not supported by the analyses.

In accordance with the reviewers' suggestions, several changes have been made to:

 

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12. Comment:

Refine language when assertions of methodological superiority or novelty are made without supporting comparisons.

Response:

We thank the Reviewer for this important comment. The manuscript was revised to moderate statements that could imply methodological superiority or unsupported novelty. Specifically, claims of definitive validation were replaced with more cautious wording that reflects the exploratory and early-stage nature of the study. Statements regarding novelty were reframed to emphasize the context-specific contribution within the Croatian setting rather than superiority over existing instruments.

Comparative statements in the Discussion and Conclusion were revised to acknowledge differences in validation approaches across studies, and terminology was harmonized to consistently reflect preliminary or staged validation.

 

In accordance with the reviewers' suggestions, several changes have been made to:

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Round 2

Reviewer 2 Report

Comments and Suggestions for Authors

Thank you for the revisions. I am satisfied with the corrections, and I have no further comments at this stage.