QUESTÕES METODOLÓGICAS METHODOLOGICAL ISSUES
International Classification of Functioning, Disability, and Health in women with breast cancer: a proposal for measurement instruments
Classificação Internacional de Funcionalidade, Incapacidade e Saúde em mulheres com câncer de mama: proposta de instrumentos para mensuração
Clasificación Internacional de Funcionalidad, Incapacidad y Salud en mujeres con cáncer de mama: propuesta de instrumentos para medición
Flávia Nascimento de CarvalhoI; Rosalina Jorge KoifmanII; Anke BergmannI, III
IInstituto Nacional de Câncer, Rio de Janeiro, Brasil
IIEscola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz, Rio de Janeiro,Brasil
IIICentro Universitário Augusto Motta, Rio de Janeiro, Brasil
The International Classification of Functioning, Disability, and Health (ICF) aims at standardization, but its applicability requires consistent instruments. In Brazil, invasive therapeutic approaches are frequent, leading to functional alterations. The current study thus aimed to identify and discuss instruments capable of measuring ICF core set codes for breast cancer. The review included ICF studies in women with breast cancer diagnosis and studies with the objective of translating and validating instruments for the Brazilian population, and consistent with the codes. Review studies, systematic or not, were excluded. Eight instruments were selected, and the WHOQOL-Bref was the most comprehensive. The use of various instruments showed 19 coinciding codes, and the instruments as a whole covered 58 of the total of 81 codes. The use of multiple instruments is time-consuming, so new studies are needed to propose parsimonious tools capable of measuring functioning in women treated for breast cancer.
Breast Neoplasms; Quality of Life; Validation Studies; Questionnaires; International Classification of Functioning, Disability and Health
A Classificação Internacional de Funcionalidade, Incapacidade e Saúde (CIF) objetiva uma normatização, entretanto sua aplicabilidade requer instrumentos compatíveis. No Brasil, abordagens terapêuticas invasivas são frequentes, levando a alterações funcionais. Nesse sentido, o presente estudo visa a identificar e discutir os instrumentos capazes de mensurar códigos do core set da CIF para câncer de mama. Foram incluídos estudos da CIF em mulheres com diagnóstico de câncer de mama e estudos com o objetivo de traduzir e validar instrumentos para a população brasileira, compatíveis com os códigos. Estudos de revisão sistemática ou não da literatura foram excluídos. Foram selecionados oito instrumentos, sendo o WHOQOL-Bref o mais abrangente. Com o uso de vários instrumentos observou-se 19 códigos coincidentes, sendo contemplados 58 do total de 81 códigos. A utilização de muitos instrumentos requer tempo, para tanto, novos trabalhos são necessários propondo ferramentas parcimoniosas, capazes de mensurar a funcionalidade entre mulheres tratadas de câncer de mama.
Neoplasias da Mama; Qualidade de Vida; Estudos de Validação; Questionários; Classificação Internacional de Funcionalidade, Incapacidade e Saúde
La Clasificación Internacional de Funcionalidad, Incapacidad y Salud (CIF) tiene por objetivo una normatización, sin embargo, su aplicabilidad requiere instrumentos compatibles. En Brasil, los enfoques terapéuticos invasivos son frecuentes, conduciendo a alteraciones funcionales. En este sentido, el presente estudio tiene por objetivo identificar y discutir los instrumentos capaces de medir los códigos del core set de la CIF para el cáncer de mama. Se incluyeron estudios de la CIF en mujeres con diagnóstico de cáncer de mama y estudios con el fin de traducir y validar instrumentos para la población brasileña, compatibles con los códigos. Los estudios de revisión sistemática o no referentes a la literatura relacionada se excluyeron. Se seleccionaron ocho instrumentos, siendo el WHOQOL-BREF el más englobador. Con el uso de varios instrumentos se observaron 19 códigos coincidentes, siendo contemplados 58 de un total de 81 códigos. La utilización de muchos instrumentos requiere tiempo, por ello, se necesitan nuevos estudios proponiendo herramientas parsimoniosas, capaces de medir la funcionalidad entre mujeres tratadas de cáncer de mama.
Neoplasias de la Mama; Calidad de Vida; Estudios de Validación; Cuestionarios; Clasificación Internacional del Funcionamiento, de la Discapacidad y de la Salud
Functioning is a complex term, the definition of which involves both physical condition and the external conditions that influence it 1,2. In order to facilitate a common language and encourage studies and public policies, the World Health Organization (WHO) elaborated the International Classification of Functioning, Disability, and Health (ICF), the objective of which is to describe health and health-related states with a holistic view of the individual and society, allowing the characterization of a person's functional capacity, considering environmental and social factors. Application of the ICF in practice is complex, and since it is a classification rather than an evaluation instrument, it does not allow objectively grading functioning, which thus require a search for alternatives to allow measurement. The classification would thereby allow a more objective reading to achieve the proposed aims.
The data obtained from the ICF are summarized in codes that include anatomical and physiological changes; task performance in a standard and habitual setting; the facilitating or limiting impact of the physical and social world's characteristics and of attitude; and the impact of individual attributes 1. The contextual and personal factors involved in the definition of functioning vary between groups, and in order to guarantee the classification's comparability, translations of the ICF should preserve to the maximum its original reliability and accuracy, thereby allowing interaction between the biomedical and social models 2,3.
The ICF consists of the conceptual basis for determining functioning or disability in chronic health 4 and the maintenance of functioning. In women diagnosed with breast cancer, treatment approaches should include issues that can favor independent performance of personal, professional, and leisure-time activities 5. The context includes complications related to performance of activities of daily living (ADLs) and social roles, referring to the concept of functioning according to the WHO 6. In Brazil, difficulties in access to the public healthcare system lead to diagnoses in more advanced stages of the disease and require more aggressive therapeutic approaches that can result in functional, emotional, and social sequelae 7,8.
The international scientific literature includes publications that have attempted to establish the relationship between the most prevalent ICF codes in given health conditions and instruments used in clinical practice 9,10,11. In Brazil, no studies have been found so far that have proposed validated instruments for measuring functioning and disability in breast cancer patients.
The brief lists of ICF codes for specific health conditions can facilitate the applicability of the classification in clinical practice. Brach et al. 12 proposed the ICF Core Set for breast cancer. This list was produced by consensus among a group of 19 experts from five different countries, which included data based on training for application of the classification and preliminary studies. This was a summary of the ICF encompassing all its components according to the health condition under study, i.e., breast cancer.
The current study proposed to identify and review the measurement instruments that have already been translated and validated for the Brazilian population, consistent with the ICF Core Set for breast cancer patients.
Materials and methods
A literature review was conducted, and studies were selected in Portuguese, English, and Spanish based on the LILACS, MEDLINE, and SciELO databases with the following descriptors: breast cancer; international classification of functioning, disability, and health; quality of life; questionnaire; and validation studies. The literature search was conducted from December 2011 to May 2012.
Inclusion criteria were: studies including the ICF in populations with breast cancer diagnosis and published since 2001 (after approval of the international use of this classification); studies aimed at the translation and validation of instruments for the Brazilian general population and that were consistent with the most prevalent ICF codes for breast cancer. This study excluded literature reviews (systematic or not) since they did not meet the current objective.
Data extraction was based on the codes obtained with the ICF Core Set for breast cancer. This summary of the classification includes 81 codes covering all the components of the classification, that is, structure, function, activities, and participation and environmental factors 12 (Table 1). This was followed by an active and manual search of the instruments validated and translated for the Brazilian population, verifying which ICF codes they covered. In order to minimize possible biases in the identification of ICF codes and instruments, the list was conducted independently by two researchers. The final version was obtained by consensus.
The instruments were selected according to the number of ICF codes they included, avoiding insofar as possible the overlapping measurement of the same codes by different instruments, since some questions were asked in a similar way in more than one validated instrument.
The review found 15 instruments on functioning that had been validated for the Brazilian population and could be used since they covered the codes proposed by the ICF Core Set for breast cancer (Table 2). Of this total, eight studies reached the widest range of codes related to the most prevalent alterations in women diagnosed with breast cancer (Table 3).
The World Health Organization Quality of Life (WHOQOL-BREF) instrument was selected since it covers a total of 31 codes, nine of which refer to body functions, nine pertaining to the component on activities and participation, and 13 codes related to environmental factors.
Another instrument identified by the review that proved consistent with evaluation using the ICF Core Set for breast cancer was the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Although it has not been validated for a female population with diagnosis of breast cancer, the instrument allows measuring 20 codes, of which seven refer to body functions and 13 to the component on activities and participation. Of these, two core set codes on mental functions, two on sensory functions and pain, two on neuromusculoskeletal functions and movement, and one on skin and related structures can be measured with this instrument. The ICF chapters related to activity and participation and covered by DASH are related to mobility, personal care, domestic living, interpersonal relations and interactions, the principal areas of life and community, social, and civic life.
The Social Support Questionnaire included a total of 13 codes from the ICF Core Set, referring to the chapters described as support and relationships and attitudes from the component on environmental factors. These codes relate to the amount of physical and emotional support to the individual by persons or animals and to the attitudes of persons external to the person whose situation is being described.
Of the instruments pertaining to specific physical examination for breast cancer, only four met the current study's criteria: computed photogrammetry, aesthesiometry (monofilaments), indirect volume, and handgrip dynamometry, encompassing 12 codes, of which nine pertaining to the body functions component and three to the body structure component.
Measurement of indirect volume is one of the components of clinical evaluation and fits the three codes in the classification described as functions of the immune system, lymphatic vessels, and lymph nodes.
Postural evaluation by computed photogrammetry is also an item of the physical examination and can provide data on mobility of joint functions and structures of the shoulder region, upper extremities, and trunk. Evaluation of functions related to exercise tolerance, muscle power, and muscle endurance can be measured with handgrip dynamometry. The physical examination also includes aesthesiometry, covering one of the ICF codes related to touch function. This instrument also evaluates the code called sensation related to the skin, since it refers to sensations such as itching and numbness.
Concluding the list of codes validated for the Brazilian population, body mass index (BMI) can also be used (based on self-reported weight and height) as a measurement instrument that provides data on weight maintenance functions.
According to the eligibility criteria defined for this study, only evaluation tools used in clinical practice and validated for the Brazilian population could be included. Thus, 23 codes did not match the instruments that were identified (b650; b660; b720; b780; b810; b820; s420; s4200; s4201; s630; s6302; s810; d177; d520; d530; d560; d570; d620; d660; e115; e555; e570; e575; and e590) (Table 1).
However, it was observed that data contained in the hospital patient chart and items from the physical examination represented by inspection and specific tests also serve as measurement instruments.
The mobility of bone functions (b720) relate to the evaluation of scapular stability in the shoulder joint complex using the Hoppenfeld maneuver. The evaluation of wounds and scar tissue includes the codes pertaining to the protective functions of the skin (b810), repair functions of the skin (b820), and structures of areas of skin (s810). The investigation of lymphatic cording (axillary web syndrome) can be related to structure of immune system such as lymphatic vessels (s4200) and lymph nodes (s4201). Evaluation of the use of external breast prosthesis can be related to products and technology for personal use in daily living (e115).
Data collection from the patient chart covers six codes, including three from the body structure component (lymph nodes, structure of the reproductive system, and breast and nipple) and two referring to environmental factors (social security services, systems, and policies and labor and employment services, systems, and policies). Data collection from the patient chart on the use of medicines for the target disease may be related to the code called products or substances for personal consumption (e110).
The study showed that seven codes referring to environmental factors (e315, e320, e325, e355, e415, e420, e425) that are covered by WHOQOL-Bref were also found in the Social Support Questionnaire. Two codes were also found in WHOQOL-Bref belonging to the body functions component (b126 and b134) and seven from the activities and participation component (d430, d720, d750, d760, d770, d850, d920), coinciding with the results obtained in DASH. Two codes, from the touch function component (b265) and sensation related to the skin (b840) can be measured by both DASH and aesthesiometry (monofilaments). Mobility of joint functions (b710) is a code that can be evaluated by DASH and physical examination, using photogrammetry. Likewise, the code called muscle power functions (b730) can be measured by DASH and by another component of the physical examination, dynamometry. The codes for structure of the shoulder region (s720) and structure of upper extremity (s730) are included in indirect volume and photogrammetry, since they allow concurrent observation of edema and injuries in these structures. After counting and excluding the coinciding codes, the validated instruments as a whole managed to capture a total of 58 codes from the ICF Core Set for breast cancer (Table 3).
All the instruments that were identified and selected in the current study have been validated for the Brazilian population, but only three are limited to the psychometric properties tested for the population of Brazilian women with breast cancer diagnosis, which may pose a certain limitation.
Among the instruments validated for diagnosis of altered sensation threshold in women that undergo breast cancer treatment, aesthesiometry or evaluation of tactile sensation with Semmes-Weinstein monofilaments is used for those that have undergone surgery 13. Indirect volume of the upper limb is another instrument validated specifically for women with breast cancer 14.
Several instruments identified as equivalent to the ICF codes are questionnaires that aim to measure quality of life, defined by the WHO as the individuals' self-rated position in life, within the context of the culture and value systems in which they live and in relation to their goals, expectations, standards, and concerns 15. Functioning is one of the domains in many of these instruments, thus explaining its affinity with the ICF 16,17.
In addition to the above instruments, the study found the Social Support Questionnaire validated for the population of women with breast cancer in Brazil 18.
The other instruments identified in the study had been validated for the Brazilian population with other health conditions. The WHOQOL-Bref, translated into Portuguese and validated in Brazil 19, used as its study population adults with major depression and contains 26 questions covering 31 of the 81 codes in the ICF Core Set. The DASH instrument, which covers 20 ICF codes, was translated and validated in Brazil 20 in 65 individuals ranging from 18 to 60 years of age, with rheumatoid arthritis and without any other condition affecting the upper limbs.
For postural evaluation, the instruments validated for the Brazilian population include computed photogrammetry, which combines digital photography with programs such as SAPo (http//:sapo.incubadora.fapesp.br), a postural evaluation software designed specifically to measure angles and horizontal and vertical distances 21. This low-cost, non-invasive method is used for both static evaluation and quantification of limitations in range of motion (ROM) in the shoulder 22, which allows recording subtle changes and interrelations between different parts of the human body that are difficult to record by other means 23. In women with breast cancer, various postural alterations have been observed using computed photogrammetry, while the main ones are forward head posture (p = 0.001) and protrusion of the shoulder ipsilateral to the surgical intervention (p = 0.001) 24.
Manual hydraulic dynamometers were evaluated for concurrent validity and intra-examiner reliability in 100 healthy individuals, obtaining results for the handgrip test 25. This instrument has proven capable of measuring total muscle power, even serving as an indicator of overall health 26,27. Dynamometry is a rapid, easy-to-perform, and reliable procedure, used by various health professionals, aimed at obtaining practical and objective information on muscle, joint, and nerve disorders 28. Several studies in the Brazilian population with diverse health conditions and age brackets have corroborated this assessment 29,30. BMI with self-reported weight and height was validated for individuals over 20 years of age from 48 sectors and proved as reliable as directly measured weight and height 31.
The Hoppenfeld maneuver allows evaluating the function of the anterior serratus muscle and characterizing the presence of winged scapula, which is consistent with ICF code b720. Patients need to be standing with their hands spread on the wall at the level of the sternum, shoulders flexed at 90º and elbows flexed such that the shoulders are close to the hands. When an alteration is present, patients are asked to extend their elbows, pushing their hands against the wall, and the medial edge of the shoulder blade bulges on the same side as the breast cancer 32,33. Although widely used in clinical practice, this evaluation instrument has not been validated for the Brazilian population and thus does not meet the current study's inclusion criteria.
Other components of the physical examination allow evaluating given codes pertaining to protective and repair functions and structures of the skin (b810, b820, and s810), but since such components are not validated instruments, they were not analyzed in the current study. The same was true for evaluation of the presence or absence of lymphatic cording (s4200). Inspection for presence of external breast prosthesis (e115) was not included, since it was not found in any of the instruments consistent with the international core set.
As observed in the results, various instruments can evaluate the same code. Temperament and personality functions (b126) and sleep functions (b134) can be measured by both the WHOQOL and the DASH. Muscle power functions (b730) can be measured by DASH and dynamometry. The functions are related to the force generated by the contraction of a muscle or groups of muscles 1, and it is thus believed that the dynamometer is the instrument that provides the most trustworthy measurements. Touch function (b265) and sensation related to the skin (b840) can be evaluated by either DASH or aesthesiometry (monofilaments). Considering sensation related to the skin as a subjective measurement, physical examination is believed to be the most accurate, through evaluation of sensation.
The activity of lifting and carrying objects (d430) can be measured by WHOQOL-Bref and DASH. Both instruments refer to moving and carrying things from one place to another, but DASH provides information that is more consistent with the respective code, related to moving while carrying light and heavy objects, greater than five kilos.
The codes on interpersonal relations and interactions (Chapter 7) in the component on activities and participation, measured by WHOQOL, also coincided with DASH. However, in WHOQOL the codes are concentrated in a single question, while DASH is a more specific instrument for measuring each code separately. Remunerative employment (d850) was also consistent with the two questionnaires. While WHOQOL aims to measure individual work satisfaction, DASH attempts to determine whether the problem with the limb has affected the individual's work. Although this involves two important aspects, specific studies are needed to verify which measure is more reliable.
The activities of recreation and leisure (d920) can also be measured with the two previously mentioned instruments, but DASH proved to be closer to this code, since this instrument allows observing the individual's capacity to participate in a leisure-time activity.
In the WHOQOL-Bref, which is consistent with codes from the component on contextual factors measured concurrently by the Social Support Questionnaire, the study showed lack of discrimination between the individuals providing the support. The Social Support Questionnaire was also more informative in relation to the ICF itself, since it determines what kind of support the various individual provide. This instrument is believed to be closer to the measurement of codes for support, relationships, and attitudes. Even so, it is not possible to determine what kind of support is provided by third parties to the individual under evaluation.
Five codes related to the functions of menstruation (b650), procreation (b660), making decisions (d177), toileting (d530), and assisting others (d660) are not possible to be measured by any of the selected instruments. The first can be measured by the Women's Health Questionnaire, validated in Brazil 34 and by the Common Toxicity Criteria, translated by Saad et al. 35. The findings of the Common Toxicity Criteria agree with the evaluation of code b660. Codes d177 and d660 can be evaluated by WHOQOL-100 36. Although there are alternatives to cover the above-mentioned codes, the application of several instruments with numerous questions becomes costly in clinical practice. Eleven codes (b720, b780, b810, b820, s420, s4200, s4201, s630, s6302, s810, and e115) are covered by components of the physical evaluation and patient chart data, which are non-validated instruments and were thus not included in this study.
The amount of instruments to be used requires the availability of patient consultation time and thus becomes a barrier to application and requires the elaboration of a single tool capable of covering as many codes as possible that describe functioning in breast cancer patients. Further research is thus important for constructing and validating an instrument that allows a single language in the field of functioning.
In order to obtain an objective language for functioning, the current study identified eight instruments that have been validated for the Brazilian population, covering 58 codes from the ICF Core Set for breast cancer. This strategy could allow the applicability of the ICF in health professionals' daily practice and allow comparison between populations from different locations, thus facilitating future studies. New studies are needed to propose a single instrument covering the Core Set of codes for breast cancer in Brazil.
F. N. Carvalho participated in the data analysis and interpretation and writing of the article. R. J. Koifman and A. Bergmann contributed to the study conceptualization and project, critical revision, and final approval.
The authors wish to thank the Physical Therapy Department of the HCIII Hospital.
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F. N. Carvalho
Instituto Nacional de Câncer.
Rua Marquês de Pombal 125
Rio de Janeiro, RJ 20230-240, Brasil
Submitted on 04/Oct/2012
Final version resubmitted on 26/Dec/2012
Approved on 17/Jan/2013