Background

The promotion of environmental health and the proper management of waste, especially the most dangerous types, are worldwide issues. Environmental contamination and occupational accidents caused by improper health-care waste management (HCWM) are on-going challenges [1–3], especially in less developed countries [4, 5]. To address these concerns, a number of political and legal mechanisms have been developed, to protect both the environment and human health against the risks associated with health-care waste (HCW) [4–7].

The hazardous nature of HCW is associated not only with blood-borne infections, mainly caused by sharps injuries, but also with diseases related to the contamination of soil, water and air caused by the inadequate treatment and/or final disposal of HCW [1–3, 8–12]. In less developed countries these problems are recurrent [4, 13] due to the poor access and precarious situation of health basic services, urban infrastructure, water supply, sewage system and waste collection, among others. In relation to HCWM, many health-care facilities (HCF) wrongly dispose their hazardous waste with the ones similar to household waste, others burn them in open dumps or in incinerators without the necessary devices for environmental contamination control, exposing the nearby communities to their toxic emissions (dioxins, mercury and particulate matter, for example) [4].

Aware of the local problems and global dimensions in the last few decades, both national and international organizations have been intensifying the effort to improve management practices [4, 14] aimed at global disease burden reduction. Health-care organizations have committed to finding solutions to the challenge of continually improving their environmental performance and to achieving measurable results [15].

Regulatory organizations, such as the Brazilian Health Surveillance Agency (Anvisa) [16], the National Environmental Council (Conama) [17] and the National Nuclear Energy Commission (Cnen) [18], are based on a mediator and regulator model, and are responsible for national policies concerning HCWM, from its inception to its final disposal (“cradle to grave” or “cradle to cradle” for recyclable waste).

These organizations have political, financial, regulation and management autonomy and through two main Federal Acts (Anvisa 2004 and Conama, 2005) [16, 17] determine that HCW generators are responsible for their correct waste management and must elaborate a free public access document relating to HCW management including the monitored indicators. The technological information center (databases) [19] of the Unified Health System – SUS (Public health care system for Brazilians and foreigners travelers over the country) [20] has an available field [21] where HCF managers must inform the category and amount of HCW generated by them.

The National Solid Waste Policy [22] is guided by the principles of sustainability and environmental protection. Although it does not deal specifically with healthcare waste, it increases the responsibility of every waste generator to provide proper final disposal. According to this policy, hazardous waste generators must develop specific waste management plans, taking the wastes’ inherent risks into consideration [23].

In this context, the main Brazilian legal regulations for HCWM [16, 17, 24] establish guidelines regarding the elaboration, and request the implementation and development of a Health-care Waste Management Plan (HCWMP) in every HCF. The HCWMP is part of an integrated management system for environmental health, and must include aspects related to all stages of waste management, professional awareness and qualifications, and occupational health and safety, as well as monitoring and evaluation (M&E) methods for proper health-care waste management [16, 24].

As a consequence of the HCWMP, researchers, interlocutors and managers have demonstrated an increasing interest in developing an integrated system for HCWM assessment [15]. Nonetheless, to our knowledge, in Brazil, no assessment tools for the straightforward evaluation of an integrated HCWM plan, adapted to various data collection modes and scopes, have yet been developed.

Among the international proposals identified, the Health-Care Waste Management – Rapid Assessment Tool (HCWM-RAT) [25] is considered the best for satisfying the evaluation criteria: scope, field investigation, methodology, robustness, origin and adaptability to the Brazilian context. This tool is part of an overall strategy developed by WHO to achieve a reduction in the disease burden attributed to inadequate health-care waste management. Assessment-in-context reviews are recommended by the WHO as a requirement for improving HCWM systems, since their implementation is unsatisfactory in health care institutions in many countries throughout the world [4, 25].

The (HCWM-RAT) [25] structure is based on a Rapid Evaluation Method (REM) and methodological triangulation: that is, a combination of qualitative and quantitative methods for collecting and analyzing data [26, 27]. This structure makes the HCWM-RAT distinct from other commonly used standard tools for gathering information on HCWM, which are based only on a check-list survey, and lack the perspective of a participative and emancipatory assessment [28].

Research in the field of environmental health evaluation, particularly for HCWM, is critical, because of the need for improving control of the spread of pollutants [29]. Cross-cultural adaptation of measuring instruments for HCWM, however, is scarce, and this study found none regarding Brazilian instruments. Furthermore, Brazil has been receiving thousands of Colombian refugees [30, 31], as well as immigrant workers from Africa and Haiti, and tourists, due to recent sports events. Brazilian health facilities must therefore be prepared not only for foreign visitors’ health assistance but also for the safe management of any HCW that might be produced.

Brazilian political structure is aligned with the principles of the World Health Organization (WHO) [4] to achieve safe and sustainable HCWM. Moreover, underlines the importance of periodic assessment to generate reliable information that will support interventions focused on ensuring best practices and waste reduction. However, through a large consensus from the literature, the use of such measuring instrument (questionnaire) made in other nations should be preceded by cross-cultural investigation (cross-cultural adaptation process) [32–37].

So, as this tool was originally developed in the U.S., cross-cultural research has been recognized as essential, to ensure the quality of translation and the cultural adaptation process [32–37], as well as to ensure equivalence between the original and the target language. This study aimed to promote a Brazilian cross-culturally adapted version of the English HCWM-RAT tool proposed by WHO [25]. It focused on equivalence of concepts, items and technical and semantic aspects, between the English and Brazilian Portuguese versions.

Methods

Instrument

The HCWM-RAT [25] is an assessment instrument consisting of a questionnaire with 85 items distributed over eight sections (toolboxes) containing 14 analysis criteria. It is structured as an electronic spreadsheet and has 8 supplementary sections: introduction, preparation, planning, contacts, glossary and abbreviations, personal observations, rating at the national level, and an inventory of all the questions.

The instrument contains five different options for answers: 1) multiple choice (C), which allows more than one option; 2) text (T),which allows open-ended answers; 3) numerical (N), which refers to the amount of generated waste and the size of the budget allotted to HCWM; 4) qualitative (Q), which allows ranking from 0 (nonexistent) to 5 (excellent); and 5) Boolean [B]: yes/no answers. The tool also provides space for the interviewer’s personal observations, to facilitate information matching. HCWM-RAT follows a logical and chronological frame, and can cover areas from the national level (ministries) to the local level (individual healthcare facilities) and considers all stakeholders involved in the issue of waste management [25].

Cross-cultural adaptation

The universal approach of Herdman, Fox-Rushby and Badia [35], was chosen because that method “emphasizes the possibility of cross-cultural variations in the nature of multidimensional concepts” [p.324]. In addition, the approach of Beaton, Guillemin and Bombardier [32] was applied to carry out the cross-cultural adaptation. To assess both conceptual equivalence and items using the cross-cultural adaptation method, a thorough literature review was carried out. A theoretical reference was built and, subsequently, constructs related to an integrated system of HCWM were analyzed [6, 8, 10, 11, 38, 39]: “sustainable development”, “safe management”, “health-care waste”, “safe handling”, “environmental health”; and political, legal, technical and operational concepts in both cultures [4, 14, 16, 17, 22, 24, 40]. Moreover, the terms adopted by the major Brazilian databases of HCWM, such as the National Register of Health Care Facilities (CNEN) [21], the National Information System on Sanitation (SNIS) [41] and the Brazilian Institute of Geography and Statistics (IBGE) [42] were verified.

As suggested in the literature, the evaluation of conceptual equivalence and items was complemented by structural analysis of the original instrument, to determine whether its various dimensions would be relevant in the Brazilian context [32, 35]. The participation of a committee of experts and a target population of the study were used to improve this process [32, 33, 36]. The committee evaluated the semantic equivalence, which involved the formal analysis of all stages of the cross-cultural adaptation process [32, 33, 36].

Conceptual questions, shown in Fig. 1, were formulated to guide the study and to help the analysis, through the following steps:

  • Step 1 (Translation): Two independent translations of the HCWM–RAT to Brazilian Portuguese (T1 and T2) were made by different certified bilingual professionals, named as Translator A and Translator B: one with previous knowledge of the theme and the other without it. This step was aimed at strengthening the possibility of finding badly formulated questions or linguistic ambiguities [32, 34–36].

  • Step 2 (Translation synthesis): Discussions of translation differences were conducted during a meeting between the translators and the author of this study, using the Nominal Group Technique (NGT) [43] to produce a synthesis of the two translations (T1-2). This process of comparison was carried out taking into consideration the original instrument, the theoretical framework, and the political and regulational context in both languages and cultures. Because the original instrument contained a large number of sections and had a complex structure, a source spreadsheet incorporating translations T1 and T2 was created, to compare the translations, in order to produce a synthesis of the two. In this source spreadsheet, the lines were identified by different background colors, identifying the two translations, while the consensual synthesis was identified by a third color pattern. The main issues and the method for achieving consensus were described in reports produced by the author of this study, using methods recommended in the literature [32].

  • Step 3 (Back translation): The back translation was performed to generate another version of the questionnaire (T1-2) in its original language (English). This process was conducted totally blind of the original version by two other different translators, whose mother tongue was English, named here Translator C and Translator D (native English-speaking back-translator, with a Doctorate in Public Health concluded in Brazil) as indicated in the methodology [32].

  • Step 4 (Back translation synthesis): The two back translations (BT1 and BT2) were systematized into a consensual version during a meeting following the same methodology explained previously, producing a synthesis (BT1-2).

  • Step 5 (Expert judgment): The semantic equivalence (connotative and denotative) [35, 36] was rated by a committee of experts, based on the three versions — the original (HCWM-RAT), T1-2, and BT1-2 — along with respective reports produced in the translation and synthesis steps [32].

    Representatives of different areas of healthcare waste management made up the committee of experts: researchers, and professionals in the fields of biosafety, hospital quality and management, occupational health, and the physics and hygiene of radiation. Translator D also took part in this group, since he was the only native speaker specialized in public health with a Doctorate in Brazil. There were also members of municipal hospitals, cleaning and hygiene staff, representatives of a municipal garbage collecting company, statistical experts, and representatives of the Sanitary Surveillance Agency, the General Coordination for Environmental Surveillance (Health Ministry) and the Brazilian Environmental Council (Environmental Ministry).

    A 2-day meeting was conducted, and since the HCWM system to be used is regulated by the government, participation from all aspects of HCW had to be obtained, to contribute positively and productively. The meeting employed a nominal group technique with audio recording [43]. The group evaluated the clarity, coherence and pertinence of all the items and sections in the tool, with respect to the Brazilian context. After analyzing the material and coming to consensus, the committee of experts, along with the author of this study, created the preliminary version to be submitted for a pre-test.

  • Step 6 (pre-test): The pre-test was presented to 39 individuals [32], who were selected for their positions as representatives of government or of one of the nine public health care facilities of the Municipality of Niteroi, Rio de Janeiro; at least one individual was selected from each of the nine facilities. An individual could be included in the sample if he or she: performed a function in a governmental sector involved with health or the environment; was a health-care facility director or manager, or a nursing supervisor; was an HCWM commissioner; or was a worker involved with health-care waste handling.

Fig. 1
figure 1

Steps of cross-cultural adaptation and guideline questions

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The pre-test was conducted with a heterogeneous group of targeted interviewees in 3 different meetings (March 2011) of 3 h each; the interviewee had to analyze as well as answer the items. A single interviewer conducted this pretest.

To answer the preliminary version of the translated instrument, the individuals had to complete a form with two questions, to evaluate the quality of the items: 1) Is it easily understood? (Y/N); 2) Is it appropriate for collecting information on an HCWM system? (Y/N). For both questions, the interviewee was also asked to rate the comprehensibility of the item and to suggest changes for improvement. When the number of “no” answers to either question for a given item exceeded 5 %, that item was included in a list for further analysis and discussion among the experts. Because a number of confusing, ambiguous or inconsistent items were identified by the sample group, a second test was conducted 2 weeks later, by a single interviewer, asking the same questions of the revised item. This second test (re-test) occurred with 83 participants [32], including HCF professionals, government representatives, and others directly or indirectly involved in HCWM systems.

Results

After analysis of the literature and regulations, and further discussions among the experts, the constructs in the original instrument were considered relevant and applicable to the Brazilian context. The concepts and dimensions were consistent with Brazilian HCWM policies, and included occupational health and safety, biosafety, ecology, and sanitation [16, 17, 24]. The 14 criteria of the original instrument were identified in the Brazilian Version of the HCWM-RAT and were grouped into five dimensions (Table 1).

Table 1 Dimensions and criteria of the health-care waste management – rapid assessment tool (HCWM-RAT) Brazilian version
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After adjustment, the original instrument could be considered applicable to Least Developed Countries (LDCs) [13] and those without regulations or policies on HCWM. Both the committee and the target population recommended the cross-cultural adaptation as being useful in Brazil. Such a cross-cultural adaptation of HCWM-RAT [25] was new and unknown in Brazil.

The aim of the committee of experts was to make the instrument suitable for use in a monitoring and evaluation program in Brazil. Changes and adequacies have followed semantic equivalence to concepts, terms and expressions from the original WHO instrument [32, 35, 36].

After evaluation of the semantic equivalence, two different translations (T1 and T2) were obtained. There were no discrepancies between the two back-translations (BT1 and BT2). During the synthesis elaboration of the translated and back-translated versions (T1-2 and BT1-2), terms such as scope, feedback, checklist, stakeholders were maintained because of their current use in Brazil, in the same cultural context.

The introduction (basic assumptions and objectives) to the Brazilian instrument included a guidance statement from, and the electronic addresses, of the Brazilian regulatory authorities (Table 2). Table 3 shows the acronyms and terms used in three official databases: the Brazilian Institute of Geography and Statistics [42]; the National Register of Health Care Facilities [21]; the National Sanitation Information System [41].

Table 2 Evaluation of conceptual, technical and semantic aspects between the Brazilian Portuguese version of the health-care waste management tool - rapid assessment tool (HCWM-RAT) and its original English version
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Table 3 Inclusion of terms, acronyms and assessment requirements: conceptual, technical and semantic evaluation
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Additional sections (e.g., glossary) provided the standardized terminology used by the health system and the Brazilian regulatory agencies. For example, terms related to health-care-waste handling were included according to the Brazilian regulatory systems, e.g.,: “Temporary storage”; “Similar to the solid urban waste” (RSU in Brazilian Portuguese); “Internal transportation” (Table 2).

Terms and items that made no sense in the Brazilian context or culture were replaced by ones commonly applied in the national information system database for health (CNES). For example, the item referring to healthcare facilities (HCF) “category” had to be changed to either “type of establishment” or “level of hierarchy” (Item 200, shown in Table 4) in accordance with HCF registration nomenclature in the Brazilian health-system database.

Table 4 Evaluation of item equivalence between the Brazilian HCWM-RAT version and the original HCWM-RAT version
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According to the committee of experts, all the items that could be answered through research in databases were listed in a separate data sheet to be collected prior to the interviewer’s field visits.

The dimension “Capacity building, safety and health” (Table 1) was included with some extra terms (Table 3, e.g., Item 304) to refer to the HCW handlers’ level of risk awareness; the original instrument did not offer parameters to classify this awareness level.

The dimension “Handling steps” was also changed to adapt to Brazilian culture. In Criteria 4 (generation) and 10 (treatment) the term “anatomical waste” was changed to “anatomical parts” (“peças anatômicas” in Brazilian Portuguese) because in the target culture the term “waste” has a negative connotation (equivalent to “garbage”), which would be considered offensive when related to human body organs or parts.

In addition, after a preliminary field version of the test, some items — for example, those referring to budget allocations for HCWM (found in Criterion 13 “Policy and budgets”) — were directed to multiple actors from different levels, a difference from the original version. The aim here was to better understand the difficulties that the HCWM staff and decision makers usually face when trying to interpret or verify rules, especially when they are not included in the decision-making processes. The suggestions and observations made by the people interviewed during the test phase were extremely helpful in producing the final version of the instrument.

Discussion

Despite the conventions signed by Brazil, such as the Basel Convention [29], the Stockholm Convention [44] and the Minamata Convention [45], and their associated regulation structures and databases (CNES; SNIS; IBGE), the segregation and collecting of health-care wastes are still primitive in most Brazilian cities.

This lack of development contributes to the paucity of knowledge about the total amount of waste generated in health-care facilities, and its real destination, in Brazil [46].

Some studies have identified the importance of training programs directed to health workers, HCW management teams and waste handling workers in order to improve the global approach on HCWM [47, 48]. However, this has been neglected in Brazil [23] and may be one of the reasons behind the difficulties on HCWM faced by this country.

The use of periodic assessments supported by a comprehensive instrument that is adapted to Brazilian context and validated in the target country (Brazil), helps not only to identify problems but also to explain its causes providing decision makers with the necessary evidence to reorient strategies.

The cross-cultural adaptation process is an approach that can be applied to many instruments developed in other cultural and linguistic settings. For Brazil, it may help to fill the data gap about the critical knots for HCWM improvement as well as to provide feedback on HCW to DATASUS database.

The objective of the adaptation is to achieve equivalence between the original measurement instrument and its adapted version [32, 35]. Therefore, the Brazilian Portuguese version of the HCWM-RAT was obtained through careful cross-cultural adaptation steps, recommended in the literature. In contrast with other cross-cultural adaptation studies that focused on epidemiological measurement instruments, this research considers an equivalence study on an environmental health measurement instrument that, as applied, will help identify and make comprehensible the HCWM framework in Brazil.

In this cross-cultural research, the constitution of a committee of experts was shown to be fundamental for the achievement of equivalence, as well as the validity of the construct, the content and the face (apparent) of the adapted instrument [32, 34, 35, 37].

While it is recognized that additional tests for evaluating the instrument’s psychometric properties are highly recommended, they are not compulsory for the validation of the translated version [32]. However, to reinforce the process of version evaluation, a 16-member committee of experts was put together, composed of researchers, one of the translators, and representatives from one of the Brazilian HCWM regulation agencies. Using the NGT [43] with the support of a moderator, this evaluation was aimed at maximizing information compilation and encouraging experts to express their opinions, while avoiding any particular expert’s domination in the discussion.

Throughout the experts’ meeting, items were examined with the goal of reaching a consensus on each item before moving on to the following one. During this process, a theoretical construct coherent with universal principles [4] yet specific to the HCWM status investigation practice [4, 16, 17] was observed.

For both the conceptual and the item-level equivalence, a consensus of keeping the original structure and items prevailed, based on the instrument modus operandi: that is, it must be used only by trained interviewers — HCWM and M&E professionals. This recommendation was also stated in the introduction to the original instrument. For instance, the maintenance of item 1400 in the Brazilian version (“Do all patients have access to/use of toilets in the healthcare facility?”) drew a great deal of attention during the expert discussion, motivating 3 rounds using the NGT [43]. Ultimately, however, the experts decided that this item should be kept as it is, and as the Brazilian instrument is applied, the interviewers would evaluate the condition of the toilets provided by each facility. This decision was attained after the group agreed that Brazil is a huge country with 283,434 health-care facilities [21], in many different socio economic and cultural scenarios, and that therefore this item would be useful for identifying infrastructure shortcomings.

The preliminary version that was obtained after 2 days of expert meetings was tested with 39 individuals [32] from the target population, with the aim of adjusting the instrument to achieve equivalence between the original source and the target version (Brazilian) in different aspects involving clarity, coherence and pertinence of the questions. The test showed that some items still received more than 5 % of negative answers for quality evaluation (again using Step 6 of the method). In other words, although the preliminary version of the Brazilian HCWM-RAT had been thoroughly evaluated by experts, eight (8) individuals of the target population considered that some items were not clear, coherent or pertinent. Consequently, some questions were modified. For example, the item referring to “national HCWM regulations,” with the question “Does their application cause any problems?” was changed to “Does the application of the established rules generate any issues?" (“a aplicação da regulamentação gera algum tipo de situação-problema?” in Brazilian Portuguese): Item 1202 in the Brazilian Portuguese version, shown in Table 4). The experts claimed that the word “problem” could not be applied to the Brazilian context since it has a negative connotation and a regulation is not designed to cause negative effects but to help guide the population.

Another example raised by the target population was in Criterion 10, where it is asked how “urban solid waste” (in place of “domestic waste,” in the original instrument) is usually treated in a health-care facility. For this population the term “treated” was not coherent because it implied the need for a method, technique or process to reduce or eliminate any inherent contamination risk, occupational accident, or environmental damage. Therefore, in order to avoid semantic discrepancies between the original and translated versions, this item was changed to “how the waste is handled - organic and recyclable” (“como são manejados – orgânicos e recicláveis” in Brazilian Portuguese), as shown in Table 4.

After the modifications applied from the testing of the preliminary version, all items received a positive evaluation, indicating that interviewees had no difficulties in understanding the questions. Table 4 shows the original items and the translated and adapted ones, in the field tests and from the committee of experts’ analysis.

Reports of the revisions were written and sent to the WHO, explaining the rationale behind the decisions that resulted in changes in the adapted version: a necessary step for the official recognition of the Brazilian version of HCWM-RAT.

Operational equivalence was evaluated during both the test and the retest; but the method of administration and the estimated time for application of the tool remained the same as for the original instrument. With emphasis on the modus operandi, equivalence refers to a comparison between the characteristics of an instrument for use in target populations (Brazilian version) and of one for use in the original population source (source instrument) [36].

The Brazilian version of HCWM-RAT has the potential to generate indicators and official database feedback, and to subsidize political decisions at different political levels among decision makers. However, an investigation of the psychometric properties of the instrument should be performed in the future [32, 33, 36].

Although a Brazilian version of HCWM-RAT has been approved, there is no guarantee that the cross-cultural adaptation was effective without the assessment of measurement equivalence, therefore, sophisticated statistical methods such as item response theory model (IRT) can be used to confirm the results of this study and it can be considered as a limitation of the study.

From this study arises the possibility for the application of the instrument to be expanded to other Portuguese-speaking countries, considering the results of Step 2 (Translation synthesis, T1-2) of the cross-cultural adaptation process.

For countries that already have guidelines and regulations on HCWM, this study may at least reduce the effort required for the research and development of their own adapted versions.

Conclusion

The results of this study show that developing a Brazilian version of HCWM-RAT can open new research paths and possibilities for expanding the comprehension of the HCWM system, as well as the critical factors to achieve proper HCW management. These factors are considered essential for the success of any HCWM Plan.

It thus supports decision-making and stimulates innovation in evaluation, for this specific field.

From this study also raises the possibility for the application of the instrument (Translation synthesis, T1-2) to other Portuguese-speaking countries. For countries that already have framework directive on HCWM, this study may at least reduce the effort required for the research and development of their own adapted versions.