Breast cancer reflects the most incident malignant neoplasm among women around the world and in Brazil, excluding non-melanoma skin cancers, corresponding to approximately 28% of new cases every year [1]. Breast cancer also affects men, but it is rare, and makes up only 1% of the total records of the disease [1].

The diagnosis of breast cancer in less developed countries like, Brazil, occurs in more advanced stages of the disease and it contributes to increasing the complications related to the treatment, interfering the quality of life and reducing survival. In an attempt to change this situation, the Brazilian National Health Policy has been prioritizing measures for control of breast cancer, through guidelines from the Ministry of Health, so that the identification of the disease occurs in the initial phase, through strategies based on measures of screening and early diagnosis of cancer [2].

Mammographic screening aims at the detection of breast lesions at an early stage of the disease and the reduction of mortality rates caused by this type of cancer through early diagnosis [ 2 ]. It is important to highlight that several risk factors are linked to the etiology of the disease, such as the woman's reproductive life and genetic characteristics, as well as hormonal and environmental factors [ 3 ]. Therefore, there are two main strategies for the detection of breast cancer: education to promote early diagnosis of the disease and annual mammographic screening in all women over 40 years of age [ 4 ].

Regarding mammographic screening, the Breast Imaging-Reporting and Data System (BI-RADS®) is an international classification developed to systematize breast assessment, interpretation of exams, and the preparation of reports of specific breast imaging exams [ 5 ]. The nomenclature of the BI-RADS® System is relevant to predict the presence of lesions suspected of malignancy in breast imaging exams [ 6 ]. There are three types of diagnostic imaging tests that are commonly used for breast assessment: mammography, ultrasound, and magnetic resonance imaging. The BI-RADS® standardization is similar for these three exams, therefore, everything that is reported will be useful for all of them and, because it is used worldwide, it allows the comparison of results from different countries as well [ 6 ].

BI-RADS® is based on values ranging from 0 to 6, where: 0 - represents the incomplete exam and in need of further evaluation; 1 - for normal examination, without changes; 2 - benign findings; 3 - probably benign; 4 - when malignancy is suspected in palpable and non-palpable lesions; 5 - highly suspicious findings; and category 6 - for the findings previously confirmed as malignant and diagnosed by means of biopsies performed [ 7 ].

Regarding knowledge to promote early diagnosis, the use of printed educational material added to the verbal guidelines has been increasingly used and works as a quick lookup technology. It is also recommended to guide health professionals in recognition of risk factors for diseases, as well as to enhance prevention, health promotion, and curative practices by transformative actions in health education [8].

The printed educational technologies, of the booklet type, proven, evaluated by experts and scientifically validated, have a fundamental role in the follow-up of health education, becoming a common practice in the Unified Health System (UHS) and working as a tool readily available for the use of professionals when necessary, in the development of care or behavior, aiming to promote population health [9, 10]. The validation of health educational technologies directed to medical and nursing professionals in the Family Health Strategy (FHS) on the diagnosis of breast cancer is an innovative tool and aims to improve the quality of the care provided [11].

It is worth clarifying that the FHS was created in 1994 as a “Family Health Program” and was implemented within the Brazilian Unified Health System (SUS) with the objective of facilitating the transition of patients through various levels of complexity and ensuring that patients receive comprehensive care and in continuity [ 12 ]. The multidisciplinary team that works in the FHS is composed of a doctor, nurse, nursing technician, and community health agent [ 13-14].

In the process of validation of printed technologies, such as booklet, it is necessary to assess the appearance and content of the material prepared, build a judgment concerning the clarity of the items, the ease of reading, understanding, and form of presentation of the instrument. This is because breast cancer, when recognized at an early stage through the identification of lesions smaller than 2 cm in diameter, has a favorable prognosis, thus requiring the implementation of strategies for early detection of the disease [15].

The use of educational technologies for the findings in imaging examinations of the breasts, such as mammography, aims to subsidize the health professional in the service and qualified referral to services of greater complexity so that the diagnosis is established early and the patient can start treatment within a maximum of 60 days, as advocated by the article 2 of Brazilian law number 12,732, of November 22, 2012 [16].

One in every three people are directly affected by cancer, and, in this context, mortality rates for breast cancer are still high, probably because of the late diagnosis at advanced stages of the disease. In this environment, early detection through mammographic screening represents the main tool for the detection at the initial phase, resulting in a greater impact on the rate of mortality of the disease [1].

The current Global Action Plan of the UN about non-communicable chronic diseases (NCCD) and the ambitious Sustainable Development Goals (SDG) of the United Nations for 2030, including the SDG 3 (good health and well-being), creates a scenario of opportunities to invest in the fight against cancer, one of the main NCCD. Considering the above, the objective of this study was to validate a booklet directed to medical and nursing professionals in the Family Health Strategy on the BI-RADS^® categorization in the description of the findings of mammography exams.

The participants included 11 experts, seven radiologists and four mastologists. Regarding the score obtained by them, according to pre-established criteria, a score ranging between 37 and 159 points was achieved. It is worth adding that the score achieved by each expert was significantly higher than the minimum set, which demonstrates the degree of reliability deposited in the specialists, evidenced by vast experience in the working area.

In the process of validation of the booklet regarding the appearance and content, there were contributions of experts in two specific Medical areas, Radiology and Mastology, with vast experience in this theme. In relation to age, the average was 45.6 years, ranging from 39.9 to 51.3 years. The mean time of being in the profession was 22.9 years, ranging between 17.1 and 28.7, with an average activity of 15.5 years in the area, minimum time of 9 and a maximum of 21.9 years of experience – this shows the high level in the evaluation, justified by the time of profession and experience of the experts (Table 1).

Regarding Medical teaching, five (45.5%) were professors and six (54.5%) worked in the area of medical education, and 10 (90.9%) had scientific production, seven (63.6%) were specialists, and four (36.4%) had completed PhDs. Of the 11 physicians experts, 10 (90.9%) possessed scientific production, one radiologist was a PhD and professor, three mastologists were PhDs and professors, one mastologist was a specialist with experience in assistance, six radiologists were specialists and one of them was a professor of Radiology and Mastology (Table 1).

Table 2 presents the six blocks containing the items related to the objectives. Content, language, relevance, layout, and appearance. Each of these further contains five items related to objectives; nine, to the content; five, to the language; six, to the relevance; eight, to the layout; and six, to the appearance. The aspects were evaluated by experts and validated separately from the calculation of the CVI. The 39 validated items were evaluated with the variations of 1 (strongly disagree), 2 (disagree), 3 (agree), and 4 (strongly agree). After the judgment of the experts, the answers 3 and 4 were calculated for valuation of the CVI and those with answers 1 and 2 were analyzed in order to be accepted or not for the new version of the booklet according to the considerations of the experts and the final examination of the researcher.

Regarding the experts’ evaluation of objectives, content, language, relevance, layout, and appearance of the items evaluated, eight obtained a CVI below 0.80, namely: 2.5; 3.6; 4.2; 6.1; 6.2; 6.3; 6.4; 6.5; and 6.6 (Table 2).

In the process of validation of the booklet, the experts made judgments regarding the content and the appearance, considering the valuation of the overall index of each criterion evaluated. The answers given by the experts were validated using the CVI calculation in accordance with the experts’ degree of agreement. The criteria evaluated correspond to the objective, content, language, relevance, layout, and appearance. The global CVI calculated for all indexes analyzed was equal to 0.89 (Table 3).

Table 4 presents a synthesis of items with individual CVI below 0.80. The assessments were described, as well as the suggestions made by the experts in each item, those that were accepted and those that were not, followed by the reason (Table 4).

The booklet obtained a CVI of 0.89, indicating a high level of agreement among the experts. The final version of the validated material had the aid of a graphic designer, containing 16 pages printed on photo paper, covered in light colors, and information arranged in short and direct texts related to BI-RADS^® classification in mammography exams. Below are the cover, the summary, and the presentation of the validated booklet (Fig. 1).

The suggestions made by the experts for items relating to language were focused on the booklet’s title, which should be modified and directed to other FHS professionals, and not only to physicians. Furthermore, they suggested deleting the term “guide therapeutic behavior”, since the booklet will be useful to guide the professionals regarding the interpretation of mammographic reports and recognition for the proper referral to specialized services.

Fig. (1). Representative illustration of the cover, development, presentation, and summary of the validated booklet “Use of BI-RADS® in the mammography exam as a guiding strategy for medical and nursing professionals in the Family Health Strategy”.

It becomes relevant to address the importance of including experts from different areas because, without their participation, it would have been impossible to validate a material with a high reliability level as it is an educational technology that involves two complementary specialties. It should be emphasized that the evaluation by professionals from different areas becomes opportune for the validation of the material with the maximum coherence with the theme addressed in the booklet, which occurred as a team, valuing the suggestions and different knowledge of professionals about the same subject [26].

Aiming to endorse a qualified evaluation of the booklet, the experts, besides being specialists in the topic, needed to assume a posture of valuation of professional experience and scientific knowledge, as pointed out in other methodological studies on the validation of an educational instrument [18, 27, 28]. Therefore, in this study, all the material was examined by mastologist experts that work in the area of women's health and radiologists responsible for the elaboration of mammographic reports, aiming to maximize the effectiveness of technology and its reliability for later use.

It should be emphasized that the analysis of the characterization of experts was a relevant factor for validation because it allowed demonstrating the experts’ profile and experience for the validation of informative material. The level of agreement to compose the reliability of the information in the content validation and adaptation of educational material is a crucial step to make the said production more relevant since only a vast knowledge allows assessing the relevance of the content presented in all items submitted to the judgment [28-36].

In this process of adaptation of the booklet, to assess the experts’ level of agreement, CVI was used because it represents a method widely used in the health area, thus allowed calculating the experts’ agreement index on certain aspects of the material individually for each evaluated item, as well as globally, involving all items [24, 37].

Other studies that addressed the validation of printed educational technology used the CVI technique for the validation of the content. For the use of the CVI, there should be a description of the calculations performed in the process of validation for each item analyzed, along with the results of the global CVI. According to a predetermined cut-off point for the CVI, the items whose results are below the cut-off point are subject to changes by the authors. It is emphasized that there is no consensus in the literature on validation of an instrument as a whole, with no standardization, because the studies address different types of instruments with adaptations suggested by experts that deal with validation of educational material [21].

In this validation process, the adopted CVI cut-off point was 0.78, i.e., all items with a CVI below 0.80 were analyzed according to the experts’ suggestions, and the items with an index over 0.80 were maintained without changes. It is important to highlight that, in this study, although some items featured a CVI below 0.80, the overall index of the booklet was 0.89. The overall CVI index justifies that the agreement between the experts on the applicability of the material was statistically significant [36].

As for the experts’ suggestions, the changes in eight items became relevant to improve the booklet. In addition, a large part of the experts consented the relevance and contribution of the material for FHS professionals as a tool to be used to optimize the early diagnosis of breast cancer, considering that any educational technology produced and used effectively can transform the population reality [10].

In relation to the content, five changes were suggested - all of which were accepted. In relation to the items assessed in relevance, there was the suggestion to emphasize the importance of mammography for the early diagnosis of breast cancer in treatment and the impact on the mortality rate. This suggestion was considered relevant, and was, thus, accepted.

Concerning appearance, five changes were suggested, of which only three were accepted. It should be emphasized that the suggestions to insert illustrations with mammographic findings to all categories of the BI-RADS^® and images of breast lesions were not followed since the material validated is fast-access and a tool to assist the interpretation of reports and systematize the referral to specialized services for health professionals, and does not focus on the therapeutic behavior. It is noteworthy that all the items evaluated in the booklet were discussed and considered appropriate according to the guidance of the specialists [37-38], making the material a quality technology to assist in the daily use of FHS professionals, being a tool for the interpretation of the mammographic exam and guidance on referring the patient to the specialized service [37-39].

Therefore, the validation of informational materials – in this case, the booklet on the use of BI-RADS^® in mammography examination – is also an opportunity to standardize and improve the performance of professionals while meeting the female population regarding breast cancer, in favor of qualified and effective assistance [9].

As the booklet undergoes the process of validity and reliability, its quality is tested, improvements are suggested, changes are made, thus, reducing the possibility of errors and increasing the approximation of credibility for use in the practice to which the material is intended [38].

In Brazil, after receiving the mammography exam from a patient and, according to the BIRADS® classification presented in the report, Primary Care is responsible for monitoring the user, forward to the reference service for diagnostic investigation, and start treatment, if confirmed, within a maximum period of 60 days [ 40 ]. For this, the FHS medical and nursing professionals need to be trained to identify suspected cases and facilitate access to specialized services in the shortest possible time [ 13 ].

Screening for breast cancer is done in different ways across countries. In Brazil, it is extremely opportune, being carried out during a medical consultation [ 2 ]. The interest in validating a booklet as an educational technology among FHS medical and nursing professionals aims to contribute an easily accessible material, which helps in the early detection of breast cancer, provides opportunities for knowledge about the interpretation of BI-RADS® and guides referral to a specialized service for adequate and timely assessment of lesions suspected of malignancy.

One of the limitations was the participation of experts from a single Brazilian state. Nevertheless, this restriction was overcome as the experts presented extensive qualifications and experience in the proposed area of study, which enabled a broad view, and commensurate with the objective of validating the said material.

The booklet was validated from the point of view of content and relevance, with a CVI of 0.89, and constituted as a new educational material for the daily activities of FHS professionals, providing knowledge about the interpretation of the mammographic report and guidance on the qualified referral of patients to specialized service.

The validation of an educational technology that facilitates the structuring, access, and exchange of information to support medical and nursing professionals in decision-making processes has repercussions in systematic and comprehensive assistance, in a timely manner, and according to the severity of the disease.