Cross-cultural Adaptation and Validation to Brazilian Portuguese of the ‘knowledge of Gestational Diabetes (Gdm)’ Questionnaire for Women With Gdm

doi:10.21203/rs.3.rs-4725366/v1

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Cross-cultural Adaptation and Validation to Brazilian Portuguese of the ‘knowledge of Gestational Diabetes (Gdm)’ Questionnaire for Women With Gdm

https://doi.org/10.21203/rs.3.rs-4725366/v1

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published 14 Sep, 2024

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Background

Gestational diabetes mellitus (GDM) is characterized by hyperglycemia during pregnancy. There are many diabetes-specific tools for collecting information validated in Brazilian Portuguese. However, there are no specific instruments to evaluate knowledge about GDM. The aim of this study was to cross-culturally adapt and validate the Brazilian Portuguese version of the Knowledge of Gestational Diabetes Mellitus questionnaire.

Methods

This study was conducted in southern Brazil from January to December 2023. Women with GDM or diabetes identified during pregnancy were considered eligible based on specific criteria. Clinical and demographic data were obtained by a medical records search. The Knowledge of Gestational Diabetes Mellitus questionnaire underwent a multistep adaptation process, including translation, back-translation, content validity assessment, and cognitive interviews. After administration to participants, internal consistency, item-total correlation, and intraclass correlation were evaluated. Confirmatory factor analysis was also conducted to ensure validity.

Results

In total, 155 pregnant women were recruited for the study. Most participants were aged 18–30 years, and hypertension was the main comorbidity (25,2%). Regarding schooling, most participants (58.7%) attended high school. The Brazilian Portuguese version of the Knowledge of Gestational Diabetes Mellitus instrument comprised 32 items. Intraclass correlation was established by two independent interviews with 57 participants, yielding a correlation coefficient of 0.79 (p < 0.01). The internal consistency (Cronbach’s α) was 0.81 overall but was less than 0.7 for the individual domains. Item-total correlations were computed, and confirmatory factor analysis indicated a good model fit. The final Brazilian Portuguese version of the questionnaire consisted of 32 items.

Conclusions

The Brazilian Portuguese version of the Knowledge of Gestational Diabetes Mellitus Questionnaire yielded a reliable and valid tool for evaluating diabetes knowledge in pregnant women.

Diabetes

gestational

Psychometrics

Health knowledge

attitudes

practice

Gestational diabetes mellitus (GDM) is diabetes diagnosed in the second or third trimester of pregnancy that is not clearly overt diabetes prior to gestation or other types of diabetes occurring throughout pregnancy, such as type 1 diabetes [1]. According to the International Diabetes Federation 2021 estimates, hyperglycemia during pregnancy affects approximately one in six pregnancies [2]. In Brazil, the prevalence of GDM is approximately 18% [3].

Studies evaluating women’s knowledge and awareness of GDM have revealed a high prevalence of poor awareness and knowledge [4, 5]. Furthermore, educated women are more likely to be aware of the importance of lifestyle and self-management, and women with higher incomes may be able to afford better nutrition and medical care [6]. In this way, knowledge could play an important role in improving GDM control. The use of tools such as questionnaires could facilitate the early identification of poor knowledge and the implementation of preventive measures.

There are more than 20 diabetes-specific instruments validated in Brazilian Portuguese, all of which are important tools for collecting information about people’s behavior, knowledge, and attitudes related to diabetes by administering standardized questions. However, there is no specific instrument for evaluating GDM [7]. Considering this, the Knowledge of Gestational Diabetes Mellitus questionnaire proved suitable for this purpose. This instrument consists of questions that address topics such as knowledge about GDM, including normal blood glucose levels, the impact of GDM on mothers and babies, knowledge of nutritional values and food choices, and principles of self-care, including blood glucose monitoring, exercise, and diet habits [8].

The assessment of knowledge about GDM and treatment adherence is a challenge, mainly due to the absence of validated instruments for this purpose in women with GDM in Brazil. The use of questionnaires for this purpose, due to their simple applicability and low cost, could enable healthcare teams to develop patient education interventions and provide a practical and quick method for use in clinical settings as well as in healthcare research.

The aim of this study was to cross-culturally adapt and validate the Brazilian Portuguese version of the Knowledge of Gestational Diabetes Mellitus questionnaire. This study was conducted in a high-risk pregnancy outpatient clinic of two university hospitals in southern Brazil (Hospital Materno Infantil Presidente Vargas, HMIPV and Hospital de Clínicas de Porto Alegre, HCPA) from January to December 2023 in accordance with the Declaration of Helsinki. This study was approved by the Scientific Committee and Research Ethical Commission of HCPA (Brazil) (Certificate of Presentation for Ethical Appreciation 62984522.9.1001.5327) and the Scientific Committee and Research Ethical Commission of HMIPV (Certificate of Presentation for Ethical Appreciation 62984522.9.2001.5329). Pregnant women diagnosed with GDM or with diabetes identified during pregnancy were selected from the medical records database of the high-risk prenatal clinics at both hospitals. Those who met the eligibility criteria were invited to participate in the study, giving their consent by signing the informed consent form.

Participants

Pregnant women were considered eligible if they were 18 years of age or older, had a diagnosis of diabetes during pregnancy or were diagnosed with GDM at least one month before, identified with a Brazilian cultural identity, and had consulted with at least one healthcare professional. Exclusion criteria included known prepregnancy diabetes, pregnant women without blood glucose records, and any communication or comprehension barriers, such as mental disorders or illiteracy. Interested eligible patients signed an informed consent form.

Clinical and demographic data, including the woman’s age, city of residence, educational level, current gestational age, self-monitoring of capillary glucose results, insulin use, current medications, diagnostic test results (transcribed if performed elsewhere or conducted at the hospital), and family history of diabetes were obtained from the patient’s medical records.

Instrument

The authors of the original questionnaire were asked for permission by email, and the study began only after their authorization. The Knowledge of Gestational Diabetes Mellitus instrument, which was originally validated by Carolan-Olah and Vasilevsli in 2021, is a structured interview developed to assess pregnant women’s knowledge about GDM (Additional file 1). The questionnaire comprises 33 questions addressing the following domains: 1. Knowledge about GDM, including normal blood glucose levels and the impact of GDM on mothers and babies; 2. Knowledge about nutritional values and food choices; 3. Knowledge about GDM self-management principles, including monitoring blood glucose levels, physical activity, and diet habits. The responses are numerically encoded, and each correct answer is scored as 1 point. Most questions have one correct answer and are scored as either correct or incorrect. Four questions have more than one correct answer and are scored as correct (all correct answers identified) or incorrect (did not identify all correct answers) [8].

Procedures and measures

The Knowledge of Gestational Diabetes Mellitus questionnaire underwent a multistep process, including translation and content validity assessment. After administration to participants, internal consistency, item-total correlation, and intraclass correlation were evaluated. Confirmatory factor analysis was also conducted to ensure validity.

The initial translation of the original instrument into Brazilian Portuguese was carried out by two independent translators who are native speakers of Brazilian Portuguese, fluent in both languages, and had different professional backgrounds from the researchers. In the synthesis process, a consensus was reached from the resulting versions, and words and phrases that showed differences were readapted [9]. The content validity was assessed by experts in the field and by the target audience.

A committee of experts in the field was assembled to produce a final version of the modified instrument. This committee comprised two pharmacists and an endocrinologist, all of whom are bilingual. The committee carefully considered each item of the instruments to better adapt them, ensuring that the translation was fully comprehensible and verifying the cross-cultural equivalence between the source and final versions. Semantic, idiomatic, experiential, and conceptual aspects were considered [10]. The synthesis version of the instrument was back-translated by a translator who is a native speaker of the original language and fluent in the target language. This translator had no prior knowledge of the instrument. Based on the translation and back-translation, a final version of the tool was obtained [11].

The final stage of the adaptation process was the content validity assessment by the target audience, also known as cognitive debriefing or pretesting, in which the instrument was applied to 30 women diagnosed with GDM or with diabetes identified during pregnancy. The participants completed the questionnaire and were interviewed to assess the comprehensibility, interpretability, and cultural relevance of the translation. Cognitive debriefing was used to obtain participants’ feedback, confirming the acceptability of the translation [9, 11]. The content validity coefficient (CVC) was determined by computing the items related to the clarity, adequacy, and comprehensibility of the questions, which were assessed on a scale from 1 to 5. The cutoff point adopted to determine satisfactory levels for language clarity and relevance was CVC ≥ 0.70 for each item and for the instrument overall [12]. The instrument was administered to pregnant women at least four weeks after their diagnosis and with the delivery date expected to last at least one month. The participants’ privacy was assured during the interviews.

Intraclass correlation was established by two independent interviews of 57 participants within 1 to 12 weeks of the previous assessment. The number of second interviews was adequate according to previous instrument validation studies [13, 14].

Statistical analysis

The Statistical Package for Social Science Professional program version 20.0 (IBM Corp., Armonk, NY, USA) and the R package lavaan (version 0.6–17) were used to carry out the analyses.

The interrater agreement was measured using the intraclass correlation coefficient. Intraclass correlation values lower than 0.5 are indicative of poor reliability, values between 0.5 and 0.75 indicate moderate reliability, values between 0.75 and 0.9 indicate good reliability, and values higher than 0.90 indicate excellent reliability [15]. Cronbach’s alpha (α) was calculated to measure internal consistency, and values above 0.7 were considered acceptable [10]. Furthermore, the impact of removing each question on the Cronbach’s alpha value was examined, which could result in the exclusion of a specific item following confirmatory factor analysis. Item-total correlations were computed. The inclusion of items with values above 0.2 is considered appropriate, and negative values, indicating a negative correlation, can represent a question inversely proportional to the others [16, 17]. The model of confirmatory factor analysis was fit using diagonally weighted least squares with robust standard errors. The comparative fit index (CFI) was used to analyze the model fit by examining the discrepancy between the data and the hypothesized model while adjusting for the issues of sample size inherent in the chi-squared test and the normed fit index [18].

Among 309 pregnant women assessed for eligibility, 155 were recruited for the study. The instrument was applied, and analyses were conducted with 155 participants, while cognitive debriefing was applied to 30 participants. Fifty-seven individuals answered the same questions with a second interviewer. Figure 1 shows the flow diagram for the selection of participants in each stage of the study.

[Figure 1]

Sociodemographic and clinical characteristics

Most participants were aged 18–30 years, and the median age was 29 (24–35) years. Ninety pregnant women were from the capital of the state (58.1%). Regarding the participants’ education, most (58.7%) had completed high school. Hypertension was the most prevalent comorbidity and was diagnosed in approximately one-quarter of women (25.2%). Most pregnant women were receiving vitamin supplements (54.2%), and 39.4% were taking insulin. The patients’ sociodemographic and clinical characteristics are shown in Table 1.

Table 1

Participant demographic and clinical characteristics
Carachteristics (n = 155)		n (%)	IC 95%
Age (years)	18–25 26–30 31–35 > 36	42 (27.1) 42 (27.1) 33 (21.3) 38 (24.5)	20.7–34.6 20.7–34.6 15.6–28.4 18.4–31.9
Instruction	Elementary school High school Higher education Uninformed	35 (22.6) 91 (58.7) 23 (14.8) 6 (3.9)	16.7–29.8 50.8–66.2 10.1–21.3 1.8–8.2
Comorbidity	Hypertension Obesity Hypothyroidism Nervous system diseases¹ Infectious diseases² Other ³	39 (25.2) 21 (13.5) 18 (11.6) 25 (16.1) 11 (7.1) 20 (12.9)	19.0–32.5 9.0–19.8 7.5–17.6 11.2–22.7 4.0–12.3 8.5–19.1
Medications	Insulin Metformin Methyldopa Prevention of pre-eclampsia⁴ Supplements and vitamins⁵ Nervous system medication⁶ Other ⁶	61 (39.4) 13 (8.4) 34 (21.9) 42 (27.1) 84 (54.2) 20 (12.9) 35 (22.6)	32.0–47.2 5.0–13.8 16.1–29.1 20.7–34.6 46.3–61.8 8.5–19.1 16.7–29.8
Variables are expressed as absolute and relative frequencies.¹ Migraine, anxiety, depression, epilepsy, borderline. ² Syphilis, toxoplasmosis, and hepatitis. ³ Cardiovascular system, coagulation disorders, neoplasias, respiratory disease. ⁴ Acetyl salicylic acid and calcium; ⁵ Ferrous sulfate, folinic acid and vitamin D; ⁶ Sertraline, escitalopram, fluoxetine, carbamazepine, quetiapine; ⁷ Sulfadiazine and pyridoxine, levothyroxine.

Sixty-two pregnant women (40%) had a family history of diabetes, while 57 (36.8%) lacked this information in their medical records. A total of 140 pregnant women (90.3%) were diagnosed with GDM. Only 10 women (6.5%) were diagnosed with type 2 diabetes, and plasma glucose levels at the time of diagnosis were not documented for five pregnant women (3.2%) in their medical records. Glycated hemoglobin (HbA1c) was described in the medical records of 47 patients (30.3%), with a mean value of 5.2% ± 0.4.

[Table 1]

Cross-cultural adaptation of the instrument

The content validity of the original Knowledge of Gestational Diabetes assessment by the evaluation committee of experts in the field revealed discrepancies between the versions provided by the two initial translators in 13 of the 33 questions, and a consensus was reached. Additionally, the other four questions were modified for cross-cultural equivalence. The result of the back-translation remained faithful to the original document.

Content validity assessment by the target group (cognitive debriefing) was carried out with 30 pregnant women. The comprehensibility, interpretation, and cultural relevance of the translation confirmed the acceptability of the translation, since most women did not encounter any difficulties in comprehending each question. Only five women expressed slight difficulty in seven questions. The CVC for each question was 1 for 26 questions, 0.99 for six questions, and 0.98 for one question. After the responses were scored, the final CVC value was 0.997.

Reliability and validity

The Brazilian Portuguese version of the Knowledge of Gestational Diabetes instrument was composed of 33 items and was completed in approximately 20 minutes. The percentage of correct answers for each question is described in Table 2. Most questions had one correct answer and were scored as either correct or incorrect. Four questions had more than one correct answer (questions 1, 2, 3 and 5) and were scored as correct (all correct answers identified) or incorrect (did not identify all correct answers). The questions with multiple correct responses exhibited the highest proportion of incorrect answers.

Table 2

Percentages of correct scores (n = 155) for questions in each of the domains of the Knowledge of GDM Questionnaire
Domain 1: Knowledge of GDM	Correct (%)	Domain 2: Knowledge of nutrition values	Correct (%)	Domain 3: Knowledge of GDM self-management	Correct (%)
Q1	3.9	Q15	63.2	Q20	88.4
Q2	0	Q16	84.5	Q21	84.5
Q3	9.7	Q17	59.4	Q22	28.4
Q4	91	Q18	87.7	Q23	52.3
Q5	11	Q19	50.3	Q24	56.8
Q6	67.7			Q25	83.2
Q7	80			Q26	65.2
Q8	84.5			Q27	98.1
Q9	77.4			Q28	81.9
Q10	58.1			Q29	57.4
Q11	67.7			Q30	70.3
Q12	61.9			Q31	73.5
Q13	81.9			Q32	92.9
Q14	69.7			Q33	50.3

[Table 2]

The intraclass correlation coefficient was 0.79 (p < 0.01), indicating good reliability. The internal consistency (Cronbach’s α) found in our study was 0.81; however, the internal consistency by domain was < 0.7 (Table 3). The item-total correlations were calculated separately for each item, and except for items 2 and 14, they were higher than the recommended level and correlated very well with the scale overall (Table 4). In terms of internal consistency reliability analysis, most item-total correlations were positive and above 0.2. One item yielded a negative value (question 14), indicating a negative correlation. Confirmatory factor analysis was conducted to examine an “a priori” three-factor structure, which consisted of each domain identified as a factor. Item 2 was removed, reducing the original 33-item scale to 32 items. These modifications were made in one set and resulted in improved model fit. The comparative fit index value of 0.936 and root mean square error of approximation of 0.048 (95% confidence interval 0.038 to 0.057) are accepted as indicators of good fit.

Table 3

Internal consistency by domains
Knowledge domain (max score)		Internal consistency (Chronbach’s α) (n = 155)
1. Knowledge of GDM	0.55
2. Knowledge of nutrition values		0.55
3. Knowledge of GDM self-management		0.72
GDM: Gestational diabetes mellitus

Table 4

Item-Total Correlation
Question	Scale Mean if Item Deleted	Scale Variance if Item Deleted	Corrected Item-Total Correlation	Cronbach's Alpha if Item Deleted
1	20.8903	25.306	0.164	0.811
2	20.9290	25.664	0.000	0.812
3	20.8323	24.959	0.208	0.810
4	20.0194	24.798	0.273	0.808
5	20.8194	24.798	0.246	0.809
6	20.2516	23.462	0.436	0.801
7	20.1290	24.620	0.222	0.810
8	20.0839	24.740	0.219	0.809
9	20.1548	24.872	0.147	0.812
10	20.3484	24.034	0.285	0.808
11	20.2516	23.969	0.321	0.806
12	20.3097	23.033	0.512	0.798
13	20.1097	24.670	0.220	0.810
14	20.2323	25.829	-0.081	0.822
15	20.2968	23.613	0.387	0.803
16	20.0839	24.558	0.271	0.808
17	20.3355	23.705	0.358	0.805
18	20.0516	24.621	0.286	0.807
19	20.4258	23.038	0.493	0.798
20	20.0452	24.290	0.401	0.804
21	20.0839	24.207	0.371	0.805
22	20.6452	24.750	0.158	0.813
23	20.4065	22.983	0.506	0.798
24	20.3613	22.960	0.516	0.797
25	20.0968	23.478	0.563	0.798
26	20.2774	23.474	0.423	0.802
27	19.9484	25.478	0.120	0.811
28	20.1097	24.683	0.217	0.810
29	20.3548	23.841	0.326	0.806
30	20.2258	24.384	0.236	0.809
31	20.1935	23.378	0.488	0.799
32	20.0000	24.636	0.376	0.806
33	20.4258	24.220	0.241	0.810

[Table 3]

[Table 4]

Seventy-three women (47.1%) achieved the fasting glycemic target, considering capillary glucose, in the measurements taken in the week preceding the interview. Seventy-nine women (51%) did not reach the target proposed by the Brazilian Society of Diabetes (95 mg/dL), and three women (1.9%) did not have their measurements documented in their medical records.

The final Brazilian Portuguese version of the Knowledge of Gestational Diabetes Mellitus questionnaire was composed of 32 items and is presented in Additional file 2.

This study’s results support the validity of a Brazilian Portuguese version of the “Knowledge of Gestational Diabetes (GDM)” questionnaire for women with GDM, indicating that it could be reliably used in future studies.

The reliability of the instrument was assessed using several methods. The internal consistency (Cronbach’s α) found in our study was 0.81, which is adequate [19], suggesting that despite the modifications, the scale remained internally consistent. However, the Cronbach’s α of the Knowledge of Gestational Diabetes domains, if analyzed individually, was < 0.7 for each domain, indicating the unreliability of the subscales when used separately. Reliability reduction when separately analyzing domains has also been observed in other studies [13].

Most questions in the original instrument have one correct answer and are scored as either correct or incorrect. Four questions had more than one correct answer and were scored as correct (all correct answers identified) or incorrect (did not identify all correct answers). Consequently, since partially correct responses were treated as incorrect in the scoring process, this criterion resulted in a substantial number of responses being categorized as incorrect in the questions with more than one correct answer, leading to a notably high percentage of inaccuracies. Despite the high prevalence of incorrect responses, these questions were retained for analysis. Some potential solutions could include considering a partially correct answer as acceptable or reformulating the questions to ensure that they offer only one correct option. Question 22, about exercise intensity, also showed a high percentage of incorrect responses, despite having only one correct option. One potential explanation is that it pertains to physical activity, and pregnant women often lack professional guidance on the appropriate intensity of exercise. Consequently, there is confusion regarding what constitutes “mild” (“leve”) or “moderate” (“moderado”) exercise.

In the item-total correlation analysis, alpha values after the exclusion of a particular item showed no significant change, with the satisfactory alpha value remaining unchanged. We did not consider question 2, with no recorded correct answers, to perform the confirmatory factor analysis. According to the confirmatory factor analysis, the test indicated that the model was well fitted. Furthermore, the two independent raters agreed on the total scores.

The results of internal reliability, item-total correlation, and intraclass correlation are consistent with studies that have also validated instruments [20–22], despite the difficulty in finding studies assessing knowledge about GDM. This fact reinforces the importance of noninvasive assessment instruments aimed at the interviewed public. However, the original questionnaire does not indicate a score to determine good knowledge. Therefore, our study also did not categorize the obtained scores.

Given the extensive and multifaceted consequences of a GDM diagnosis, it is challenging to assess adequate control using only a single capillary glucose monitoring measure. Continuous glucose monitoring, a new method addressed in some studies, offers an alternative for accurately assessing glycemic control. This method provides more precise values and has shown promising results [23, 24]. We recognize that analyzing the relationship between scale scores and glycemic control (predictive validity) should be useful; however, we cannot accurately assess glycemic control.

There are several limitations to consider in this study. First, the test-retest evaluation period ranged from 1 to 12 weeks, aligning with the typical frequency of multidisciplinary consultations for pregnant women. The extended interval was due to women missing appointments or not having available time to respond to the questionnaire. This timeline may explain the enhanced learning and discrepancies in responses between the two interviews. Additionally, this period coincided with various physiological changes in the participants’ bodies, concerns about the baby, and the need to adapt to numerous new situations, all of which may have impacted their willingness to participate in the questionnaire. Within this demographic, the onset of diabetes represents only one aspect of the multitude of changes experienced during pregnancy.

The findings of this study offer substantial evidence supporting the validity of a Brazilian Portuguese version of an instrument designed to assess knowledge about GDM. This suggests that the instrument holds promise for reliable use in future research endeavors.

The translation, adaptation, and validation processes collectively indicated that the questionnaire accurately assessed knowledge about diabetes in pregnant women. Therefore, the adapted Brazilian Portuguese version of the evaluated instrument displayed satisfactory psychometric properties and validity, producing comparable outcomes, barring its specific characteristics. It serves as a significant alternative for researchers to evaluate and comprehend pregnant women’s awareness of GDM. The instrument effectively identifies knowledge deficiencies among pregnant women with diabetes and has the potential to improve the efficacy of educational strategies and interventions aimed at supporting diabetes self-care.

CFI: comparative fit index

CVC: content validity coefficient

GDM: Gestational diabetes mellitus

HCPA: Hospital de Clínicas de Porto Alegre

HMIPV: Hospital Materno Infantil Presidente Vargas

Ethics approval and consent to participate

This study was approved by the Scientific Committee and Research Ethical Commission of HCPA (Brazil) (Certificate of Presentation for Ethical Appreciation 62984522.9.1001.5327) and the Scientific Committee and Research Ethical Commission of HMIPV (Certificate of Presentation for Ethical Appreciation 62984522.9.2001.5329). Pregnant women diagnosed with GDM or with diabetes identified during pregnancy were invited to participate in the study, giving their consent by signing the informed consent form.

Consent for publication

Not applicable.

Availability of data and materials

The datasets generated and analyzed during the current study are not publicly available, but are available from the corresponding author.

Competing interests

The authors declare that they have no competing interests.

Funding

This study was supported by Financiamento e Incentivo à Pesquisa (Fipe/HCPA), grant number 20220319.

Authors' contributions

LBP, BDS, and PMB designed the work and interpreted the data. LBP, HTS, JKS, and PCBC collected the data. LBP and PMB analyzed the data and drafted the manuscript. All authors read and approved the final manuscript.

Acknowledgments

The authors also acknowledge Gustavo Thomas (Unidade de bioestatistica e análise de dados do Hospital de Clinicas de Porto Alegre), who conducted the statistical analysis.

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No competing interests reported.

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Reviewers agreed at journal
21 Jul, 2024
Reviewers invited by journal
16 Jul, 2024
Editor assigned by journal
12 Jul, 2024
Submission checks completed at journal
12 Jul, 2024
First submitted to journal
11 Jul, 2024

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Cross-cultural Adaptation and Validation to Brazilian Portuguese of the ‘knowledge of Gestational Diabetes (Gdm)’ Questionnaire for Women With Gdm

Status:

Journal Publication

Version 1

Abstract

Background

Methods

Results

Conclusions

Figures

BACKGROUND

METHODS

Participants

Instrument

Procedures and measures

Statistical analysis

RESULTS

Sociodemographic and clinical characteristics

[Table 1]

Cross-cultural adaptation of the instrument

Reliability and validity

[Table 2]

[Table 3]

[Table 4]

DISCUSSION

Conclusions

Abbreviations

Declarations

References

Additional Declarations

Supplementary Files

Status:

Journal Publication

Version 1