The Science of Diabetes Self-Management and Care 2025, Vol. 51(6) 589–601 © The Author(s) 2025 Article reuse guidelines: sagepub.com/journals-permissions DOI: 10.1177/26350106251378721 journals.sagepub.com/home/tde
Abstract
Purpose: The purpose of the study was to translate, adapt, and validate the Type 2 Diabetes Distress Assessment Tool (T2-DDAS) for use in individuals with type 2 diabetes mellitus (T2DM) in Brazil. Considering the risks arising from glycemic instability, emotional regulation has become fundamental in the management of T2DM. Therefore, having valid instruments to assess emotional stress is essential. Method: A methodological study was conducted consisting of the following steps: initial translation of the instrument by 2 independent bilingual translators, synthesis of the translated versions, back-translation by 2 additional bilingual translators, analysis by a committee of experts, pretesting of the consolidated version with 32 patients with T2DM treated at an adult outpatient clinic in a tertiary hospital in southeastern Brazil, submission of the translated version to the author of the original instrument, and content validation. Content validity was verified using the content validity index (CVI), content validity ratio (CVR), and modified kappa, ensuring the adequacy of the items for the target population.
Results: Most items obtained a CVI ≥0.80, indicating good adequacy. Minor modifications were made based on participants’ suggestions, improving the clarity of the items. The final version of the T2-DDAS in Brazilian Portuguese demonstrated high validity and adequacy for the Brazilian sociocultural context.
Conclusion: The Brazilian version of the T2-DDAS showed semantic and conceptual equivalence with the original, having been validated with methodological rigor. The results confirm its applicability to assess emotional distress in people with T2DM in Brazil.
Behavioral changes for the self-management of diabetes mellitus (DM) have been widely reported in the literature as a key factor in the treatment of the disease and the achievement of satisfactory clinical outcomes, including adequate glycemic control.1 To attain these outcomes, patients with DM must learn to deal with the multifaceted demands of the disease, including those involving clinical, psychosocial, educational, and behavioral aspects, and to implement changes in their daily routines to achieve effective self-management of DM.1,2
However, the emotional burden imposed by self-management can lead to diabetes-related distress, called diabetes distress (DD), a frequently overlooked factor that has significant clinical implications.3 DD refers to the emotional stress experienced by patients as they continuously manage a chronic and challenging condition; this stress is highly prevalent, with estimates ranging from 30% to 53% among individuals with type 1 diabetes and type 2 diabetes (T2DM), respectively, and is also associated with poor glycemic control, lower medication adherence, and inadequate diet and physical activity.4,5
Furthermore, high levels of DD can significantly compromise patients’ quality of life.6 In this context, recognizing, assessing, and intervening in DD is essential to optimizing self-management and improving treatment effectiveness.
The Diabetes Distress Scale (DDS), developed in 2005, stands out among the instruments available in the international literature for assessing emotional distress related to diabetes.7 Now available in over 30 languages,8 the DDS is widely accepted for identifying DD in routine care and is used in clinical trials as an outcome measure to evaluate the impact of new medications, devices, and behavioral interventions in diabetes care.9-11 Moreover, routine monitoring of DD—especially when treatment goals are not being met or when complications begin to appear—is recommended by international guidelines, with a particular emphasis on the use of the DDS.12,13
In recent years, the management of DM has undergone significant changes, driven by the introduction of new devices, medications, and therapeutic regimens; transformations in care delivery; and increased public awareness of the disease.14 Given this evolving scenario, the researchers responsible for the development and validation of the DDS recognized the need to expand their approach to include aspects that had not been previously addressed.14
Among the newly evaluated domains, of particular note are concerns about access to health care, social determinants of health, and diabetes-specific issues, such as shame, stigma, and fear of hypoglycemia, all of which are now recognized as critical sources of emotional distress in diabetes.15-17
To keep pace with these changes and more comprehensively capture the emotional experience of living with T2DM, the researchers developed and validated the Type 2 Diabetes Distress Assessment System (T2-DDAS).8 This new tool includes a core measure designed to assess the intensity of emotional distress associated with diabetes in addition to a set of complementary measures that identify key specific sources of emotional burden. These factors encompass 7 core dimensions: challenges in disease management, relationship with health care professionals, fear of hypoglycemia, concerns about long-term health, interpersonal issues, shame and stigma, and access to health care services.8
Given this scenario and considering that T2DM is associated with the risk of complications arising from glycemic instability, emotional regulation has become a key element in the management of the disease. Assessing emotional stress through a valid and reliable instrument is the first step toward effective intervention, not only allowing the identification of the difficulties faced by patients but also guiding them in adopting strategies to reduce the demands imposed by diabetes and promote a better quality of life. Thus, the aim of the present study was to translate, cross-culturally adapt, and validate the content of the T2-DDAS for Brazilian patients with T2DM.
This was a methodological study comprising the following steps: synthesis of the translations, back-translation, review and content validation by an expert committee, testing of the final version, and submission to the original author of the instrument.7,18 The research adhered to the recommendations of the criteria adopted by the checklist of the Consensus-Based Standards for the Selection of Health Measurement Instruments.19,20
The T2-DDAS is an instrument developed to assess the emotional distress associated with T2DM.8 It consists of 2 main sections: general and causes. The general section, comprising Questions 1 to 8, aims to identify the baseline level of distress associated with living with diabetes. The score for this section is calculated based on the average of the 8 items, reflecting the degree, intensity, or general perception of distress reported by the individual, with higher scores indicating greater emotional distress. The causes section, comprising Questions 9 to 29, assesses 7 specific causes of emotional distress related to T2DM. Each of these causes encompasses a particular aspect of living with and managing the condition, which may contribute to the individual’s emotional distress.
Hypoglycemia issues are addressed in Questions 11, 17, and 27; long-term health concerns in Questions 12, 18, and 24; health care providers in Questions 13, 16, and 28; interpersonal problems in Questions 10, 21, and 29; shame/stigma in Questions 14, 20, and 22; access to health care services in Questions 9, 23, and 25; and the demands of diabetes management in Questions 15, 19, and 26. Each cause must be analyzed separately, without summing the scores into an overall total.
The overall score is obtained by calculating the average of the responses to the 8 items, and the causes are scored individually by summing the responses to the related items and dividing by the number of items. The higher the score, the greater the emotional impact of the cause is. Focusing on the causes with higher scores allows for a better understanding of the aspects that most affect the well-being of the person living with diabetes.8 Figure 1 illustrates the methodological flowchart of the study.
The English version of the T2-DDAS was independently translated into Brazilian Portuguese by 2 bilingual translators, both fluent in English and native speakers of Brazilian Portuguese. One translator (T1) had experience in the health care field and was informed about both the purpose of the translation and the objectives of the instrument. The other translator (T2) had no experience in the health care field and completed the translation without any knowledge of the purpose of the instrument. To minimize potential conceptual and idiomatic distortions, the research team compared both versions and discussed any discrepancies before synthesizing the translations.
The 2 translations (T1 and T2) were analyzed and compared by the research team. Discrepancies between T1 and T2 were examined and resolved through consensus. Based on this consensus, a single version of the instrument was synthesized, referred to as the “Portuguese version” (VPT).
The synthesized version (VPT) was subsequently translated back into English by 2 additional bilingual translators, both native English speakers. The back-translations were carried out independently, with no prior knowledge of the original version, its concepts, or intended purposes. Upon completion of this stage, 2 versions were obtained: back-translation 1 and back-translation 2.
Content validity refers to the extent to which items of an instrument adequately represent the construct it is intended to measure. In the context of cross-cultural translation and adaptation, ensuring content validity is crucial to preserve the conceptual integrity of the original instrument while making it relevant and comprehensible to a target population. Without rigorous assessment of content validity, there is a risk of compromising the accuracy, comparability, and applicability of the instrument in the new cultural setting.
In this stage, the original version of the T2-DDAS was compared with the translated versions (T1 and T2) and the synthesized version (VPT) by a committee of experts for content validity, evaluated semantic-idiomatic equivalent, cultural equivalent, and conceptual equivalence, with the goal of developing a version of the tool suitable for pretesting. The following inclusion criteria were used to recruit the experts: being an expert in the care of people with DM, holding a master’s or doctorate, being proficient in both English and Portuguese, possessing knowledge and/or skills acquired through at least 5 years of professional experience (in care, teaching, or research), and having experience in cross-cultural adaptation.
Experts who responded to the data collection instrument incompletely and/or did not return it within 30 days were excluded. The experts were recruited through a network of contacts, including emails of corresponding authors of scientific articles published in the field.
For data collection, formal invitations were sent by email to each participant, including the study’s objective, the informed consent form, the T2-DDAS, a brief sociodemographic characterization tool, and a form containing a 4-point Likert scale for evaluating the T2-DDAS items. Three properties were evaluated: semantic-idiomatic equivalence, which verifies whether the translation into Portuguese maintains the original meaning in English; cultural equivalence, which assesses whether the situations described in the items reflect the reality of the population’s cultural context; and conceptual equivalence, which evaluates whether the items truly measure the emotional distress of individuals with diabetes, ensuring their alignment with the original version of the instrument.
The items were assessed according to the following criteria: equivalence (1 = nonequivalent sentence, 2 = impossible to assess equivalence without review, 3 = equivalent sentence but requiring minor adjustments, 4 = fully equivalent sentence), relevance (1 = definitely not relevant, 2 = not relevant, 3 = relevant, 4 = definitely relevant), and comprehensiveness (1 = not comprehensive, 2 = slightly comprehensive, 3 = comprehensive, 4 = highly comprehensive). To ensure independence in the evaluation, each expert performed the analysis individually, without any influence from the other members. After 30 days, the sample consisted of 9 experts, resulting in a satisfactory sample size as recommended in the literature.21
After the experts’ feedback, the researchers calculated the content validity index (CVI) and the content validity ratio (CVR) to assess the content validity of the instrument. They also reviewed all the suggestions and justifications to develop the prefinal version of the T2-DDAS, which was then sent to the target audience (pretest) for comprehensibility assessment.
This phase aimed to identify potential issues with the prefinal version and assess the item comprehensibility.18 The test was conducted with individuals with T2DM, recruited from a general adult outpatient clinic at a tertiary care hospital in southeastern Brazil.
Participants included individuals diagnosed with T2DM for at least 1 year, ages 18 or older, and capable of effective communication. Exclusion criteria included pregnancy, hospitalization within the previous 30 days, and those with serious complications related to T2DM. Patients were selected by convenience sampling in the waiting room prior to medical appointments. Previously trained interviewers invited eligible patients to participate and guided them to a private setting.
The sample consisted of 32 individuals who completed a questionnaire including sociodemographic and clinical characteristics (participant identification; sociodemographic profile: sex, marital status, education, family arrangement, and household income; clinical information: time since T2DM diagnosis, current treatment regimen) and the T2-DDAS.
The interviewers provided printed versions of the materials, read the instructions aloud, and explained how to complete the questionnaire. Upon completion, the cognitive interview technique22 was used to investigate comprehensibility, detect potential ambiguities or misinterpretations, and assess the cultural relevance of the translated instrument among individuals with T2DM.
Interviewers encouraged participants to share their perspectives. The following aspects were evaluated: (a) comprehension of questions (“What did you think of this instrument for assessing emotional distress in people with diabetes?”; “What is your opinion about the instructions?”; “What do you think of each question in the instrument?”), (b) memory retrieval (“Did you find it easy or difficult to respond to the instrument?”; “Which parts were easiest, and which were most challenging?”), (c) decision-making process (“Were there any questions that caused ambiguity or were difficult to interpret?”; “Would you suggest any changes?”), and (d) response process (“Today we validated an instrument on what topic?”, “What were the main key points addressed?”). Items deemed difficult to understand were reformulated or excluded after a second round of review by the expert committee.
In this step, the original author of the instrument received a detailed report of the translation and adaptation process, which included all versions produced throughout the stages. After reviewing, the author suggested adjustments to 3 questions to ensure semantic accuracy. These suggestions were discussed with the translators and subsequently presented to the expert committee. The committee evaluated and adjusted the questions as needed, ensuring that the original meaning was preserved in the context of the adaptation.
Content validity was assessed using the CVI and the CVR. To evaluate the relevance, clarity, and simplicity of each item, a 4-point Likert scale was used to calculate the CVI. Values ranging from 0.40 to 0.59 were considered reasonable, from 0.60 to 0.74 good, and above 0.74 excellent.23,24
To determine the necessity of each item, experts applied the CVR approach. The experts were asked to rate the necessity of each item on a scale from 1 to 4. According to the Lawshe25 table, a CVR value of 0.78 or higher is considered acceptable for a panel of 9 experts. Agreement among the expert committee was assessed using the kappa coefficient.26 Values between 0.40 and 0.59 were considered reasonable, between 0.60 and 0.74 good, and above 0.74 excellent.26 These analyses ensured that the instrument was valid, relevant, and culturally appropriate for the Brazilian population.
Descriptive analysis was applied to both the sociodemographic characteristics of the pretest participants and the experts’ profiles considering their experience and language proficiency and evaluating the distribution of scores for each item. In the qualitative approach, suggestions for adjustments to the instrument items, obtained through cognitive interviews during the pretest, were analyzed and incorporated into the final version, ensuring greater clarity and cultural appropriateness.22
The local Research Ethics Committee approved the study under Approval No. CAAE: 85273424.8.0000.5404. Authorization for the cultural adaptation and evaluation of the T2-DDAS measurement properties was granted by the primary author of the instrument.
The translation, synthesis of translations, and back-translation stages were conducted without difficulties by experienced professionals. The T2-DDAS instrument was subsequently submitted to evaluation by a committee of 9 experts for content validation.
The committee was comprised of 8 women and 1 man, representing all 5 regions of Brazil. The team included 3 postdoctoral researchers, 4 PhDs, and 1 master’s degree holder, with an average time since graduation of 23.1 years (±12.1). With regard to professional activity, 88% of the experts had worked in educational institutions in the last 12 months, and 12% had also worked in hospital settings.
All members had both clinical and academic experience focused on the care of individuals with T2DM. The average duration of clinical experience was 16.6 years (±21.6), and the average academic experience was 15.3 years (SD ±7.3).
Table 1 presents the estimates of the CVI, modified kappa, and CVR for the overall assessment of the T2-DDAS. The measurements, performed across various domains of the scale, aimed to assess the precision and validity of the instrument in the context of T2DM. The overall CVI for each domain with values above 0.95 demonstrates strong content validity across semantic, conceptual, and cultural aspects.
In the modified kappa analysis, which measures interrater agreement adjusted for chance, values exceeded 0.95, indicating excellent agreement among the experts regarding item equivalence. Furthermore, with regard to the CVR, which evaluates item relevance, values equal to or greater than 0.78 were found—considered adequate and achieved in all domains of the scale.
In the semantic-idiomatic equivalence analysis, 89.7% of the items (26 out of 29) showed CVI ≥0.80, indicating good adequacy. Items 13, 18, and 25 presented CVIs below 0.78 and required revision. In conceptual equivalence, 96.6% of the items (28 out of 29) reached CVI ≥0.80, with Item 13 being the only item below that threshold. In cultural equivalence, all items (29 out of 29) had CVI ≥0.80, indicating high cultural adequacy.
The modified kappa for all items was ≥0.74, indicating good agreement among the experts. Thus, Items 13, 18, and 25 had CVIs below the recommended threshold in 1 or more categories and required revision to improve clarity and content validity. The detailed revisions are presented in the following.
For Item 13, “When it comes to health care professionals’ care, I feel upset about having to deal with my diabetes most of the time on my own”, the following CVIs were observed: 0.89 (semantic-idiomatic), 0.78 (conceptual), and 1.00 (cultural), with modified kappa values of 0.89, 0.76, and 1.00, respectively. The CVI for conceptual equivalence was slightly below the ideal value (0.78), suggesting variability in the experts’ interpretation of the concept.
However, the modified kappa was adequate (0.76 for conceptual equivalence), indicating good overall agreement. The change in the proposed VPT provided a more detailed description of the situation of “being alone with diabetes” by specifying “having to deal with my diabetes most of the time alone,” which may improve conceptual clarity and potentially increase the CVI in future assessments.
In Item 18, “I can’t escape the unpleasant feeling that diabetes will eventually cause me serious problems,” the CVI values were 0.78 (semantic-idiomatic), 0.89 (conceptual), and 0.89 (cultural), with modified kappa values of 0.76 (semantic-idiomatic), 0.89 (conceptual), and 0.89 (cultural). The semantic-idiomatic equivalence showed a CVI of 0.78, which is below the ideal, and the modified kappa was also the lowest (0.76). This suggests that the item’s wording may have led to differing interpretations among the experts. The revision in the VPT, which replaced the expression “sinking feeling” with “difficult feeling” and added “diabetes will end up causing me serious problems,” may help improve semantic clarity and thus increase the CVI.
In Item 25, “I worry about the difficulty of getting to medical appointments or to the pharmacy,” the CVI values were 0.78 (semantic-idiomatic), 0.89 (conceptual), 0.89 (cultural), with modified kappa values of 0.76 (semanticidiomatic), 0.89 (conceptual), and 0.89 (cultural). As in Item 18, the CVI value in the semantic-idiomatic equivalence was below the ideal, with a corresponding modified kappa of 0.76. The revision of the wording, which simplified the sentence and added clarification about access, may help improve semantic clarity, although a more direct approach to access could be even more effective.
Items 2, 3, 4, 6, 7, 8, 16, 26, and 29, although they presented adequate CVI and modified kappa values, received specific grammatical adjustments, as detailed in Table 2. The synthesized version of the remaining items remained unchanged, identical to the prefinal version of the T2-DDAS.
In the prefinal version testing stage, the instrument was administered to a sample of 32 participants with T2DM. Table 3 presents the data regarding the sociodemographic and clinical characteristics of the sample.
During the cognitive interviews, participants considered the items either understandable or partially understandable. All participant suggestions were accepted regardless of the values obtained for the CVI and CVR. Adjustments were made to Items 2, 3, 15, 18, 25, and 29, preserving the semantic equivalence of the original content and ensuring clarity for the target population.
Participants shared reflections such as “It is very important to assess the emotional suffering that diabetes causes” (Participant 1), “I liked the questions because they reflect what we feel” (Participant 25), “The instrument was easy to answer” (Participant 15), “Identifying our feelings is very important because sometimes exhaustion takes over” (Participant 18), “It makes us reflect on how demanding diabetes treatment is” (Participant 4), and “There is so much involved in diabetes, and that causes us suffering . . . this scale is useful for professionals to assess those feelings” (Participant 22).
Subsequently, a second round of expert committee evaluation was conducted to review the suggestions. The changes to the items are described in Table 4.
At the end of all the previous steps, the final version of the T2-DDAS-Brazilian version was sent to the original author along with a detailed report on the process of developing the final version of the instrument, including previous versions derived from the translations. The author provided feedback on 3 issues:
Question 7: The author requested that the translation of the term “never go away” into Portuguese be reevaluated, and the researchers concluded that the term “never go away” was maintained. Question 23: The author requested that the translation of the term “healthy food” into Portuguese be reevaluated, and the researchers concluded that the term “healthy food” was the most appropriate for the sentence. Question 24: The author pointed out that the translation “I feel that I may suffer serious complications” did not adequately reflect the tone of inevitability and despair in the original. After discussion, the researchers adjusted the translation to “I feel that serious diabetes complications are inevitable,” which better captures the tone of inevitability in the original.
The cross-cultural adaptation of instruments requires rigorous methodology to ensure semantic and conceptual equivalence and guarantee that the translated version remains faithful to the original instrument.18,27 In the present study, the Brazilian version of the T2-DDAS followed all methodological steps, including back-translation and expert validation, and was therefore supported by robust, established recommendations.18-20
The expert committee, composed predominantly of nurses with advanced academic degrees and both clinical and academic experience, ensured the accuracy and applicability of the instrument in the Brazilian context. The use of the CVI and the modified kappa yielded highly positive results. Most items had a CVI ≥0.80, and the overall CVI was 0.97. This finding demonstrates that the experts considered the items highly representative for assessing emotional burden related to T2DM. CVI values ≥0.90 are indicative of excellent content validity, according to previous studies on the cross-cultural adaptation of health instruments.28
With regard to the modified kappa, values ranged from 0.95 to 1.00, indicating a high level of agreement among the experts in their assessment of the items. According to Landis and Koch,26 values above 0.74 indicate excellent agreement, which further reinforces the robustness of the validation process. The CVR, falling within the criteria established by Lawshe,25 also confirmed the adequacy of the instrument’s items. These findings support that the translated version of the T2-DDAS maintained the conceptual consistency and clinical relevance of the original instrument.8
Domain analysis revealed that items related to shame/stigma (CVI = 1.00) and hypoglycemia (CVI = 1.00) yielded the highest CVI values compared with other domains. A CVI of 1.00 indicates absolute consensus among experts regarding the relevance and content validity of the instrument. These findings align with a systematic review with meta-analysis29 that identified a significant association between elevated stigma levels and increased psychological distress in diabetes. Moreover, a statement from an international multidisciplinary panel30 emphasized that diabetes-related stigma undermines not only emotional well-being but also mental and physical health and negatively affects self-care and access to appropriate health care services.
Regarding the hypoglycemia domain, a systematic review31 reported that severe hypoglycemic episodes are strongly associated with increased fear of recurrence, diminished emotional well-being, and reduced health-related quality of life. Additionally, another study32 found that high fear of hypoglycemia significantly correlates with elevated diabetes-related distress. These findings31,32 underscore the role of hypoglycemic episodes as a trigger for psychological distress in individuals with T2DM, further supporting the validity of this domain in the instrument used in the present study.
Emotional distress associated with diabetes has been widely addressed in the scientific literature33-36 because of its impact on disease management. Such distress adversely affects quality of life, leading to poorer psychosocial outcomes, lower adherence to self-care behaviors, and less effective management strategies.34,37 Therefore, the cognitive interview phase was crucial for ensuring the instrument’s comprehensibility, clarity, and appropriateness for the target population. Participants reported that the items were understandable or partially understandable, indicating that the initial adaptation was successful. Adjustments were made to certain items to preserve semantic equivalence and enhance clarity. Implementing these modifications reflects a participant-centered approach, confirming the instrument’s applicability in clinical and research settings and aligning with methodological guidelines for cross-cultural adaptation.18,37
Perceptions of emotional distress may vary across cultures, influencing how individuals with diabetes cope with their condition and seek support. Thus, an adapted instrument must capture linguistic and contextual nuances without compromising equivalence to the original version. The assessment of emotional stress among people living with T2DM is becoming increasingly important. Therefore, the adaptation of specific instruments can help determine the patient’s level of stress to propose targeted interventions for each context. It also contributes to comparing research findings across countries and to implementing interventions that support management, with the aim of improving quality of life and minimizing long-term chronic complications.
The final version of the instrument demonstrated satisfactory validity, reinforcing its utility for identifying and monitoring emotional distress in people with T2DM. Looking ahead, further studies are needed to evaluate the measurement properties of the Brazilian version of the T2-DDAS, facilitating its broader adoption in education, clinical practice, and research.
The Brazilian version of the T2-DDAS was translated, adapted, and validated with methodological rigor, ensuring semantic and conceptual equivalence with the original instrument. Content validation, based on the CVI, modified kappa, and CVR, confirmed the representativeness and adequacy of the items for assessing emotional distress in people with T2DM in Brazil. The cognitive interview phase ensured the instrument’s comprehensibility and applicability, confirming its clinical relevance. Therefore, the T2-DDAS proved to be a validated tool for use in research and clinical practice within the Brazilian context.
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
The authors received no financial support for the research, authorship, and/or publication of this article.
This study was approved by Ethical Committee at State University of Campinas (No. 85273424.8.0000.5404).
Danilo Donizetti Trevisan https://orcid.org/0000-0002-6998-9166
Bruna Andrade Oliveira https://orcid.org/0000-0002-7313-5630
Maria Helena Melo Lima https://orcid.org/0000-0001-6521-8324
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From School of Nursing, State University of Campinas, Campinas, São Paulo, Brazil (Dr Apolinário, Ms Roque, Ms Andrade de Oliveira, Prof Lima); School of Nursing, Federal University of Sao Joao del-Rei, Campus Centro Oeste, Divinópolis, Minas Gerais, Brazil (Ms Ferreira, Prof Trevisan); and Faculty of Nursing, Universidad Andrés Bello, Viña del Mar, Chile (Prof de Oliveira).
Corresponding Author: Maria Helena Melo Lima, School of Nursing State University of Campinas, 126 Tessália Vieira de Camargo Street, Cidade Universitária, Campinas/SP 13083-887, Brazil. Email: melolima@unicamp.br
