INTRODUCTION

Several factors are related to therapeutic interventions in the treatment of chronic musculoskeletal pain. The physical, psychological, social, cognitive, emotional and sensory elements involved in the interactions between the patient and the healthcare professional during treatment are called contextual factors (CFs)¹,² . CFs can be internal, external or relational² . Internal factors represent the patient's memories, emotions, expectations and psychological characteristics, while external factors include the physical aspects of the therapy, such as the type of treatment and the place where the treatment is carried out. Relational factors are characterized by the social interactions of the patient-therapist relationship, therapist characteristics, and patient characteristics² . CFs can have a positive or negative impact on symptoms and clinical outcomes. The clinical effects related to CFs can vary from large to small, depending on the characteristics of the patient, the professional, the clinical condition and the intervention³ . Positive expectations can enhance the beneficial effects of a treatment, while negative expectations can generate adverse effects. Clinical history, pain severity and patient expectations are key elements in the prognosis of musculoskeletal conditions. Effective communication strategies are essential to minimize negative expectations and symptoms of anxiety⁴ . A greater understanding of CFs in clinical practice will favor the decision for more effective interventions and can optimize the results of treatments for musculoskeletal pain⁵ .

Chronic musculoskeletal pain represents a significant challenge for individuals and health systems. In 2019, musculoskeletal diseases affected 1.71 billion people worldwide, with low back pain being the most prevalent in 134 of the 204 countries analyzed⁶ . It is estimated that by 2050, the number of cases of low back pain will increase by 36.4%⁷ . In Brazil, the prevalence of chronic pain in the adult population ranges from 23.02% to 42.33%⁸ , affecting mainly women⁹ . Low back pain affects more than 50% of Brazilian adults over the course of a year, with between 4.2% and 14.7% of the population suffering from chronic low back pain¹⁰ .

Pain is defined as “an unpleasant sensory and emotional experience associated with or similar to that associated with actual or potential tissue damage”¹¹ . Measuring the sensation of pain can result in a wide variety of therapeutic approaches and more effective treatment¹² . Clinicians and researchers encounter difficulties in assessing and measuring pain due to its subjective nature, the scarcity of reliable instruments and the variety of patient characteristics and types of pain¹³ .

Assessing the interference of CFs in the treatment of musculoskeletal pain is challenging. The Healing Encounters and Attitudes Lists (HEAL) tool was developed using the rigorous Patient-Reported Outcomes Measurement Information System methodology and its objective is to assess patients' attitudes and perceptions about various components of treatment that are associated with clinical outcomes¹⁴ .

HEAL is made up of six subscales: patient-therapist connection, health environment, positive outlook, treatment expectancy, spirituality and attitude towards complementary and alternative medicine¹⁴ . The sub-scales can be administered in full or short form with 6 to 7 items in each domain. Participants are asked to rate the items in relation to their current treatment on a five-point Likert scale¹⁴,¹⁵ . The original version of the HEAL showed excellent reliability for each subscale¹⁴ , while the German version showed adequate reliability¹⁵ .

In clinical applications, HEAL can help health professionals identify factors that influence therapeutic outcomes and the experience of care¹⁴,¹⁶ . Despite the importance and growing use of self-administered measurement instruments, no instrument validated for Brazil assesses the interference of CFs in health treatments. Thus, the present study’s objective was to translate and cross-culturally adapt the short form of the HEAL tool for the Brazilian context.

METHODS

Study design

A translation and cross-cultural adaptation study of the short form of the HEAL tool was conducted, following the guidelines of the Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures¹⁷ . The study was approved by the Research Ethics Committee of the Augusto Motta University Center (CAAE: 57253022.0.0000.5235). All participants signed the Free and Informed Consent Term (FICT) after being informed about the nature of the research and procedures. This study is in line with the principles and standards of the General Personal Data Protection Law (Lei Geral de Proteção de Dados Pessoais - LGPD), Law No. 13,709/2018.

Procedures

After authorization from the main author of HEAL, the original English version was translated by two experienced bilingual translators, one of whom was a native speaker of Portuguese and fluent in English, and the other a native speaker of English and fluent in Brazilian Portuguese. The version reconciled by the researcher responsible for this study was back-translated by two independent translators with the same credentials as the direct translators, who were not involved in the first stage. The harmonized Brazilian Portuguese version was then submitted to an expert committee made up of three physiotherapists experts in musculoskeletal pain, a psychologist and an applied linguistics researcher.

The committee agreed on the semantic, idiomatic and conceptual equivalence between the English version and the final Portuguese version of the subscales. This last version was also sent to a Brazilian Portuguese teacher for an orthographic and grammatical analysis. A few changes were made to keep the language simple and clear for the Brazilian context, without altering the genuine meaning of the individual questions.

The pre-test was then conducted with 30 patients undergoing physical therapy for musculoskeletal conditions, recruited for convenience from the outpatient physiotherapy service at the Federal Institute of Rio de Janeiro (Instituto Federal do Rio de Janeiro - IFRJ), during the month of October 2023. The patients were over 18 years old and had chronic musculoskeletal pain (lasting more than 3 months).

Statistical analysis

A descriptive analysis on the sociodemographic and clinical data of the pre-test participants was carried out. Continuous variables were presented as mean and standard deviation (SD), and categorical variables were presented as absolute values and proportions (%). The internal consistency of the HEAL tool was assessed using the Cronbach's alpha test, which was considered adequate if it was equal to or greater than 0.70¹⁸ . The data was tabulated using Excel (Microsoft, U.S.A.) and statistical analysis was carried out using Jeffrey's Amazing Statistics Program (JASP) software version 0.18.1.0.

RESULTS

Four bilingual translators, two for direct translation and two for back-translation, created the first translated version of the HEAL tool. In the first translated version, there were some differences generated by the bilingual translators, which were resolved by consensus in discussions between the main study researchers. In the Healthcare Environment sub-scale, the verb “was” was initially translated as “era” and “foi”, and remained as “era” in the final version. The noun “friendly” was translated as “simpática” and “amigável”, and the term “simpática” was chosen for the final version. In the same sub-scale, the noun “helpful” was translated as “prestativa” and “útil”, and the term “prestativa” was chosen for the final version. In the Patient-Provider Connection subscale, the title itself was translated into “Conexão paciente-profissional” and “Conexão paciente-terapeuta”, the latter being chosen for the final version because it is widely used in the literature.

Next, the verb “provides” was translated as “oferece” and “fornece”, and the term “fornece” was chosen. In the Attitudes Toward Complementary and Alternative Medicine (CAM) subscale, the noun “effective” was translated as “eficaz” and “efetiva”, and the term “efetiva” was chosen. In Positive Outlook, the term “about my future” was translated as “em relação ao meu futuro” and “sobre meu futuro”, and the term “em relação ao meu futuro” was chosen. In this same sub-scale, the term “about myself” was translated as “comigo mesmo” and “sobre mim mesmo”, and after the evaluation the term “em relação a mim mesmo” was chosen in order to maintain the coherence with the previous questions. In the Spirituality subscale, the term “supported” was translated as “amparado” and “apoiado”, and the term “apoiado” was chosen for the final version (Table 1).

An expert committee made up of three physical therapists experts in the musculoskeletal area, a behavioral psychologist and an applied linguistics researcher approved the translation with 80% agreement. Simple grammatical adjustments were suggested to improve the understanding of the items in Brazilian Portuguese for the general population. For example, it was suggested to add the article “(a)” after several masculine nouns in the subscales, to cover the female sex. And in the “Patient-therapist connection” subscale, it was suggested that the question “Meu profissional de saúde me dá apoio e encorajamento” be replaced by “Meu profissional de saúde me apoia e me encoraja”, so that it is clearer for the Brazilian population. The suggestions were incorporated into the sub-scales (Table 2).

The pre-test sample was mostly made up of women (86.7%) with high school degrees. Osteoarthritis, hypertension and hypercholesterolemia were the most frequent comorbidities in the pre-test participants. The patients were on average 60 years old and reported pain on an average of 5 days a week, mostly moderate, and high levels of functional limitation (Table 3).

During the pre-test, 70% of patients had doubts when answering the Attitudes Toward CAM subscale, as they were unfamiliar with the term “Complementary and Alternative Medicine”. In the final version, the final option was to replace the term “Complementary and Alternative Medicine” with “Terapias Alternativas”, and to add examples to each of the six questions in the subscale (Table 2). The most difficult question was “I prefer CAM to conventional medicine”, which was changed to “Prefiro as Terapias Alternativas no lugar (ou ao invés) da medicina convencional”. Two patients were exclude for not completing the sociodemographic questionnaire and were therefore not fit for the analysis. Participants in the pre-test showed a good understanding of the HEAL tool, although some items (Attitudes towards CAM) required the inclusion of examples more familiar to Brazilian culture.

All the subscales showed excellent correlations between the items, according to the following Cronbach's alpha values: Health Environment [0.907 (95% CI 0.833; 0.951)], Treatment Expectation [0.922 (95% CI 0.868; 0.957)], Patient-Therapist Connection [0.91 (95% CI 0.848; 0.950)], Attitudes towards alternative therapies [0.900 (95% CI 0.825; 0.946)], Positive outlook [0.886 (95% CI 0.800; 0.939)], and Spirituality [0.901 (95% CI 0.888; 0.961)].

DISCUSSION

This study presented the process of translation and cross-cultural adaptation of the short form HEAL tool for Brazilians, following internationally accepted methodological procedures. Several phases of the translation and cross-cultural adaptation process were completed properly, including a pre-test with patients from the target population. Based on the high agreement of the expert committee and degree of comprehension of the pre-test participants, as well as excellent internal consistency, the process of cross-cultural adaptation of the short forms HEAL tool was considered successful.

The present findings corroborate HEAL's adequate level of reliability, as shown in previous studies. The original paper found a Cronbach's alpha coefficient of between 0.93 and 0.97 for the subscales of the short form HEAL tool¹⁴ , while the German version showed an internal consistency of between 0.74 and 0.93¹⁵ . The original document showed excellent reliability for each subscale, showing that the tool has a robust internal structure. Although the internal consistency in the German version is slightly lower compared to the original tool, all values are still considered acceptable and indicate good reliability for the translated version.

In the original study of the HEAL tool, an exploratory factor analysis was carried out which identified a unidimensional structure for each subscale, with good factor loadings on the corresponding items¹⁴ . Considering that the sub-scales are independent, and each has its own final score, a consistency calculation was carried out for each sub-scale and the values found indicate excellent internal consistency and corroborate the reliability of the adapted version for the Brazilian context, similarly to the original version.

The version of HEAL adapted for Brazil offers a comprehensive view of the non-specific factors that can influence clinical treatment. The high internal consistency of the sub-scales confirms the tool's suitability for measuring these factors in the Brazilian context, reflecting the robustness observed in the original¹⁴ and German¹⁵ versions. The items have qualitative characteristics, but the questionnaires offer quantitative results, making it possible to verify which CFs have the greatest influence on healthcare.

One of the main limitations of the present study is the selection bias in the test sample, which was homogeneous due to the predominance of females, limiting external validity of the resulting values presented. More future studies need to be carried out to access standardized values for the Brazilian population. It was considered important that future studies expand to a more diverse group compatible with the Brazilian population. Another limitation is the lack of a more robust analysis of other measurement properties of the tool, such as construct validity, structural validity and responsiveness. It is suggested that further work be carried out to fully evaluate the measurement properties of the Brazilian version of the HEAL tool.

CONCLUSION

The Brazilian version of the short form HEAL tool is available after a process of translation and cross-cultural adaptation. The tool can be used in future research and in clinical practice to identify the CFs that influence treatment of Brazilians with chronic musculoskeletal pain. Caution is advised in its use until further research has evaluated more extensively its psychometric properties.

ACKNOWLEDGEMENTS

The authors would like to thank Portuguese language teacher Lídia Dias do Amaral Corrêa for the grammatical revision of the translated HEAL instrument, contributing to the quality of the tool in the Brazilian context.

References

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