Study Type

This is a psychometric cross-cultural adaptation and content validity assessment of BIPROSCAB for use in Brazil, conducted from April 2021 to January 2022. Authorization was obtained from the original authors. The cross-cultural adaptation (Stage A, Steps A1 to A5) was conducted following Beaton's method^[17], with an additional evaluation of the back-translations by the authors of the original BIPROSCAB. Content validity assessment (Stage B) was carried out as proposed by Alexandre et al.^[18].

Stage A) Cross-Cultural Adaptation

Step A1. Translation: Two Brazilian translators with proficiency in English independently translated the instrument, producing translations T1 and T2. The first was a professional translator with no experience in the healthcare field, while the second translator was a nurse with a Ph.D.

Step A2. Synthesis of T1 and T2: T1 and T2 were synthesized by a third translator (a Brazilian nurse proficient in English, specialized in Cardiology, holding a Ph.D), producing version ST-12.

Step A3. Back-translations of ST-12: Two professional translators (native English speakers fluent in Brazilian Portuguese, living in Brazil, with no experience in the healthcare field) independently back-translated version ST1-2 into English, producing versions BT-1 and BT-2.

Step A4. Review of BT-1 and BT-2 by the original BIPROSCAB authors: To verify whether ST1-2 was equivalent to the original BIPROSCAB, BT-1 and BT-2 were shared with the authors of the original instrument. The authors were asked to identify potential inconsistencies that would lead to a revision of versions T1 and T2.

Step A5. Assessment of linguistic equivalences by a panel of experts: A search for potential experts was carried out on the Lattes Platform of the Brazilian National Council for Scientific and Technological Development (Conselho Nacional de Desenvolvimento Científico e Tecnológico or CNPQ), using the keywords “myocardial revascularization” and “prognosis”, filtering for nurses with Ph.D. Additionally, cardiovascular surgeons and a Portuguese language specialist were invited.

The panel consisted of 11 experts: one physician with a Ph.D. in Cardiovascular Surgery, six nurses with a Ph.D. in Cardiology, one nurse with a post-doctorate in Psychometrics, one Linguistic professional specialized in Portuguese, and the two translators from Steps A1 and A3. The experts received an instrument to evaluate whether the items in ST-12 were equivalent to the original BIPROSCAB using the Delphi technique. Each round of evaluation had a 15-day deadline.

Experts were asked to assess equivalence on a scale where: -1 = not equivalent, 0 = undecided, and +1 = equivalent. If an expert considered any item as not equivalent or undecided, suggestions for changes were requested. Four types of linguistic equivalences were assessed: semantic equivalence (words have the same meaning, and possible grammatical changes in translation were considered), idiomatic equivalence (translated idiomatic and colloquial expressions have the same meaning in the local cultural context), cultural equivalence (translated items were considered in relation to the life experiences of the Brazilian population), and conceptual equivalence (the meaning is representative of the concept of interest)^[19].

The percentage of agreement among experts was assessed using the formula: number of participants who scored +1 divided by the total number of judges multiplied by 100. Items with < 80% agreement were re-assessed by the researchers, taking into account the comments and suggestions of the experts, and resubmitted for analysis until achieving adequate agreement^[18].

Stage B) Evaluation of Content Validity of the Adapted Version of BIPROSCAB

Content validity was assessed by two groups: professional experts and post-CABG patients.

Step B1. Assessment of content validity by professional experts: the same experts from Stage A, Step A5, individually evaluated the items of ST-12 in terms of clarity (whether the item was drafted in a way that the concept is understandable and adequately expresses what is expected to be measured), theoretical relevance (whether the item demonstrates the cognitive processes of interest), and practical pertinence (whether the item reflects the involved concepts, is relevant, and suitable for achieving the proposed objectives)^[18]. Evaluations were conducted on a 4-point Likert scale: 1 = not clear/not relevant/not pertinent, 2 = somewhat clear/somewhat relevant/somewhat pertinent, 3 = quite clear/quite relevant/quite pertinent, 4 = very clear/very relevant/very pertinent^[19]. For each evaluated item, the content validity ratio (CVR) was calculated using the formula:

Where: ne = number of experts who scored 4, and N = number of experts.

CVR values were considered appropriate based on the number of experts, following Ayre & Scally's recommendations. For 11 judges, the authors determine that a CVR of 0.636 is necessary to achieve a one-tailed P-value of 0.033^[20]. Suggestions were evaluated by the researchers, and items were modified based on suggestions and subjected to new rounds of assessment until satisfactory CVR values were obtained.

Step B2. Assessment of content validity by post-coronary CABG patients: the version of BIPROSCAB validated by the group of professional experts was formatted in Calibri font size 14 and administered to 40 patients aged ≥ 18 years who had undergone isolated elective CABG and were able to read and write in Portuguese. Potential participants were approached by the principal investigator during their first postoperative follow-up visit to the Coronary Outpatient Clinic of a public hospital in the state of São Paulo, which typically occurs around 30 days after hospital discharge. Clinical characteristics were collected from their records.

Patient performance in responding to BIPROSCAB was analyzed descriptively. Participants were also interviewed regarding the visual appearance of the instrument (structure and organization of items), font size adequacy, and understanding of instructions and items. Response patterns to the items were assessed by the researchers.

Patient data were entered and analyzed using Microsoft Office Excel 16.3. Categorical variables were expressed as absolute and relative frequencies (n, %). Continuous variables were presented as mean ± standard deviation or median (1st quartile - 3rd quartile). The project was approved by the Research Ethics Committees of the Universidade Federal de São Paulo (Process no. 3.735.512) and the Instituto Dante Pazzanese de Cardiologia (Process no. 3.912.299). All participants signed consent forms.

Cross-Cultural Adaptation

In Step A1, Translation, there were word selection discrepancies in Portuguese between the translators, but no semantic differences. In Step A2, the synthesis of translations favored terms that maintained consistency with the original version while facilitating comprehension by a population with lower educational levels. For example, item 17, "Eu desenvolvi infecção no tórax onde cortaram para propósito da cirurgia." was synthesized as "Eu desenvolvi uma infecção no peito onde fizeram o corte para a cirurgia.", and item 12, "Eu tive dificuldade em adormecer." was synthesized as "Eu tive dificuldade em cair no sono."

In Step A3, Back-translations, there were no significant discrepancies between the back-translators, and in Step A4, the authors of the original BIPROSCAB considered that the synthesized version maintained consistency with the original.

In Step A5, Assessment of Linguistic Equivalences by a Panel of Experts, in the first round of evaluation, item 12 had an agreement rate < 80% for idiomatic and cultural equivalences and was modified based on suggestions (Supplementary Table 1). Although item 19 did not have an agreement rate < 80% for any type of equivalence, the modification suggestions were considered relevant by the researchers and accepted (Supplementary Table 1).

Supplementary Table 1. - Analysis of linguistic equivalences of the Brazilian adapted version of the Biopsychosocial Prognosis Scale for Coronary Artery Bypass Grafting (n=11 experts).

Therefore, two items (12 and 19) were subjected to a second round of assessment of linguistic equivalences. In the third and final equivalence analysis, item 19 achieved an agreement rate > 80% (Supplementary Table 1). A detailed account of the suggestions made by the experts that were accepted by the researchers is provided in Supplementary Table 2.

Supplementary Table 2. - Suggestions from the judges that were accepted by the researchers.

Content Validity

After the equivalence analysis, only one round of content assessment by the same group of experts was necessary for clarity, theoretical relevance, and practical pertinence to be considered adequate by the experts, with CVR > 0.636 for all items (Table 1).

Table 1. - Content validity ratio per item and overall for the Brazilian adapted version of the Biopsychosocial Prognosis Scale for Coronary Artery Bypass Grafting (n=11 experts).

Content Assessment by Patients

Forty patients were invited to participate in the study, and all accepted. Patient characteristics are presented in Table 2. Most patients were elderly, male, active in the job market, had incomplete elementary education, of mixed ethnicity, hypertensive, and received outpatient care from the Central de Regulação de Ofertas de Serviços de Saúde of the State Health Department.

Table 2. - Sociodemographic and clinical characteristics of postoperative patients after coronary artery bypass grafting (n=40).

The response scale originally configured in BIPROSCAB has a descending order of symptom frequency (1 = very often, 2 = 4-5 times, 3 = 2-3 times, 4 = only once, and 5 = never). However, as mentioned by the participants, with support from the literature^[21], this configuration requires greater cognitive effort for a response, which can lead to an inaccurate representation of the attribute being measured. Ascending response scales are more intuitive, as respondents tend to associate higher values with a greater intensity or quantity of the attribute being measured^[21]. Therefore, in the Brazilian version, it was decided to reverse the order of the response scale to "1 = never, 2 = only once, 3 = 2-3 times, 4 = 4-5 times, and 5 = very often". Thus, the lower the score, the better the biopsychosocial prognosis.

There were no suggestions or complaints regarding font size, type, and formatting. The performance of patients in responding to BIPROSCAB - Brazilian Version (BIPROSCAB-Br) is presented in Table 3. The average score of the participants was 49.7, with a standard deviation of 17.1.

Table 3. - Performance of patients undergoing coronary artery bypass grafting (CABG) when responding to the Biopsychosocial Prognosis Scale for Coronary Artery Bypass Grafting - Brazilian Version (n=40).

The domains that stood out with a better response pattern considering their possible minimum and maximum scores (lower scores, representing a better prognosis) were: Infection and interference in daily life, Socialization limitation, and Physical pain. The items with the highest score (representing a worse prognosis) were Post-CABG affect state, Post-CABG anxiety, and Discomfort in surgical sites. The final version of BIPROSCAB-Br is presented in Supplementary Figure 1.

Clinical Implications

The BIPROSCAB not only provides a comprehensive view of post-CABG experiences but also potentially allows for the development of personalized care plans that address the specific psychosocial, bio-social, and bio-physiological aspects identified. By understanding the patient's perspective on various dimensions, clinicians can engage in more meaningful and targeted discussions, fostering effective communication and shared decision-making, ultimately leading to improved outcomes and enhanced quality of life^{[21,24,25,27,28,29,30,31,32,33]}.

The identification of psychosocial factors (Post-CABG affect state, Post-CABG anxiety, Worry about return to normalcy, and Constraints in socializing) underscores the emotional and social dimensions of a patient's recovery journey. Recognizing aspects such as psychological state, anxiety levels, concerns about returning to normal life, and social limitations can drive the development of interventions supporting emotional well-being and facilitating smoother social reintegration^{[21,24,25,27,28,29,30,31,32,33]}.

Addressing bio-social factors (CABG bio-social by-products, Infection and interference to routine life) demands a comprehensive care approach that extends to the broader implications of CABG, including its impact on a patient's social life and daily routines. Implementing strategies to assist patients and their families in adapting to these changes, managing stressors, and maintaining social connections may enhance overall recovery^{[21,24,25,27,28,29,30,31,32,33]}.

The acknowledgment of purely bio-physiological factors (Post-CABG physical pain, Discomfort in surgical sites, and Discomfort in the leg) underscores the importance of managing physical symptoms directly linked to the surgical procedure. This information can guide clinicians in developing targeted strategies for pain management and ensuring physical comfort during the recovery process. The presence of post-CABG physical pain and discomfort in surgical sites requires tailored pain management strategies, considering the individual's pain threshold and overall health status. Close monitoring of discomfort in surgical sites goes beyond routine care, requiring additional attention, alongside patient education regarding self-monitoring and decision-making regarding complications^{[21,24,25,27,28,29,30,31,32,33]}.

Limitations

This study should be considered in light of some limitations. The instrument's content was evaluated in only one specialized healthcare center, which may not represent the experience of most CABG patients in Brazil. In this initial analysis, tests have not yet been conducted with patients from different regions and contexts.