Abstract
Introduction: The International Classification of Functioning, Disability and Health (ICF) provides a unified framework and standardized language for describing health. It is encouraged to be used to monitor functional achievements throughout patients’ therapeutic process. Physiotherapy should provide and examine care with appropriate standardized assessments. To address both needs, a tool based on the ICF codes and qualifiers was created to monitor the therapeutic process of patients with physical disabilities.
Objective: To validate the content of a physiotherapeutic functional assessment tool for children and adults with physical disabilities based on ICF codes and qualifiers.
Methods: A prospective cross-sectional content-validity study was performed. The instrument was sent to 30 physiotherapists specialized in the care of individuals with physical disabilities to be evaluated for its comprehensibility, relevance and applicability for adult and pediatric population. The content validity index (CVI) was used to determine the interrater agreement, and a minimum of 90% was considered acceptable.
Results: At first, one item was considered incomprehensible (CVI ≤ 90%); and, together with other six items that received important suggestions, they were revised and considered comprehensible after revision. Forty items were considered relevant for both populations, although some differences led to two different instruments.
Conclusion: We were able to provide an ICF based tool with highly comprehensible and relevant items to address individuals with physical disabilities.
Keywords:
International Classification of Functioning; Disability and Health; Neurological physiotherapy; Outcome and Process Assessment (Health Care); Rehabilitation
Resumo
Introdução: A Classificação Internacional de Funcionalidade, Incapacidade e Saúde (CIF) fornece uma estrutura unificada e uma linguagem padronizada para descrever a saúde. Seu uso é incentivado para monitorar as conquistas funcionais ao longo do processo terapêutico dos pacientes. A fisioterapia deve fornecer e examinar os cuidados com avaliações padronizadas apropriadas. Para atender a ambas as necessidades, foi criada uma ferramenta baseada nos códigos e qualificadores da CIF para monitorar o processo terapêutico de pacientes com deficiência física.
Objetivo: Validar o conteúdo de um instrumento de avaliação funcional fisioterapêutica para crianças e adultos com deficiência física com base nos códigos e qualificadores da CIF.
Métodos: Realizou-se um estudo prospectivo transversal de validade de conteúdo. O instrumento foi enviado a 30 fisioterapeutas especializados no atendimento de pessoas com deficiência física para avaliação quanto à sua compreensão, relevância e aplicabilidade para a população adulta e pediátrica. O índice de validade de conteúdo (IVC) foi utilizado para determinar a concordância entre avaliadores, sendo considerado aceitável um mínimo de 90%.
Resultados: A princípio, um item foi considerado incompreensível (IVC ≤ 90%); e, junto a outros seis itens que receberam sugestões importantes, os itens foram revisados e considerados compreensíveis após revisão. Quarenta itens foram considerados relevantes para ambas as populações, embora algumas diferenças tenham levado a dois instrumentos diferentes.
Conclusão: Conseguiu-se fornecer uma ferramenta baseada na CIF com itens altamente compreensíveis e relevantes para abordar indivíduos com deficiência física.
Palavras-chave:
Classificação Internacional de Funcionalidade; Incapacidade e Saúde; Fisioterapia neurológica; Avaliação de Processos e Resultados em Cuidados de Saúde; Reabilitação
Introduction
The International Classification of Functioning, Disability and Health (ICF) provides a unified framework and standardized language for describing health and its components. The ICF presents a biopsychosocial approach that focuses on functioning instead of disease. It defines functioning as an umbrella term indicating a positive interaction between individuals and their contextual (environmental and personal) factors.1
Rehabilitation facilitates a positive interaction by adjusting contextual factors and maximizing capacity to complete tasks, which allows individuals with health conditions to participate in community life.2
Patients’ rehabilitation and functional evolution must be monitored throughout their therapeutic process. Physiotherapeutic evaluation demands the use of appropriate standardized assessments in clinical practice to appraise the impact of functional gains, incorporate them into the perspective of the patients and family members, and help therapists and family to set new goals.3 Not all rehabilitation centers perform patients’ continuous assessments routinely and rarely they consider a comprehensive biopsychosocial instrument for their approach,4,5 although its use is encouraged.6,7
The World Health Organization (WHO) has extensively investigated the best practical use for ICF, which is strongly recommended for physiotherapeutic therapy care worldwide.8,9 Despite not being an evaluation tool, it may help professionals in guiding the continuous assessment of their patients, and it aims to generate reliable data on the functional status of the world's population for large-scale consumption.10 Although the use in clinical practice is progressing, it must be matured to improve measurement, statistics, and communication in the health field. Initiatives that implement ICF-based assessments in routine work such ours, offer a more reliable assessment and documentation in rehabilitation and assists therapists to consider all domains of participation when planning their service. 10,11
Some authors are involved in linking the content of existent instruments to ICF conceptual framework, however few related them with the ICF qualifiers.11,12 The qualifiers indicate the magnitude of the patients’ conditions, but its generic scale can be considered too broad for practical use, presenting moderate-to-weak interrater validity.8,12-14 It is recommended the ICF to be associated with assessment tools and have their psychometric characteristics evaluated for clinical use.15 To address this need, the Association for the Assistance of the Disabled Children (Associação de Assistência à Criança Deficiente, AACD), a Brazilian rehabilitation center, created an instrument based on the ICF codes and qualifiers for physiotherapists to monitor the therapeutic process of patients with physical disabilities.
The aim of this study was to validate the content of the instrument designed for physiotherapy functional assessment of individuals with physical disabilities based on ICF codes and qualifiers throughout their rehabilitation process. We hypothesized that the tool was comprehensible and addressed relevant content for the studied population.
Methods
This is a cross-sectional content-validity study of a therapeutic follow-up tool developed based on ICF qualifiers. The instrument properties analyzed were comprehensibility and relevance from the perspective of the professionals. It was approved by the Research Ethics Committee of the AACD under protocol No. 50942921.9.0000.0085. For content validity definition and selection of statistical methods, we followed Souza et al.'s approach.16 The study design was also based on the items suggested by the COSMIN – Study Design Checklist for Patient-Reported Outcome Measurement Instruments.17
The instrument was developed in the physiotherapy divisions of the institution from 2016 to 2018, by a group of physiotherapists. It was designed to assess functioning of population with physical disabilities in a language accessible to both therapists and users during the patient's evaluation and throughout their process.
The group selected several ICF codes that corresponded to the most common complaints/objectives chosen by physiotherapists to address children and adults with physical disabilities. For each ICF code the group either searched and adapted a literature validated test or created the qualifiers descriptions following the generic ICF suggested magnitudes (in cases there were none validated tool available). We maintained the codes descriptions from the original manual and described each qualifier. The final version comprised 62 codes, covering domains of body functions, activities and participation, and environmental factors. The detailed process of the tool creation was previously reported.18,19
To apply the tool, physiotherapists must choose a specific task and use the related ICF code and qualifiers to better understand the magnitude of patients’ condition. One code at a time is applied individually for a specific period, directing the therapeutic goal and measuring patients´ evolution during said period.
Physiotherapists working at AACD and external physiotherapists (who do not work at the institution) who were acquainted to the research group were screened based on the following inclusion criteria: participants should be specialized in the care of individuals with physical disabilities and have at least five years of experience.
Accordingly, the initial sample of judges was composed by 56 physiotherapists from the institution (which were grouped by areas of expertise: 16 pediatric, 18 aquatic, and 22 adult physiotherapists) and 30 external physiotherapists (composing the last group) who met the inclusion criteria. From each group seven or eight judges were randomly selected (via the website Sortear.net) until completing seven external physiotherapists, seven pediatric, eight adult and eight aquatic physiotherapists experts. The research group contacted each of the selected judges inviting them to participate in the research and sending the access link by email. From that moment on, the researchers were unaware of the participants who agreed on participating in the study, as the questionnaires were anonymous.
Participants who did not accept the proposed terms or sent unfinished questionnaires were excluded from the study, and a new invitation with a link was sent to the next judge from the randomly selected physiotherapists groups until the expected sample size of 30 questionnaires was reached. The target of 30 responses was considered adequate by the COSMIN checklist.17
We assessed the comprehensibility of qualifiers descriptions and the relevance of its content in two stages. For both stages, links to the online questionnaires, created using the free software tool SurveyMonkey, were sent to the participants’ email addresses. The link contained general explanations of the study and forms for informed consent and data confidentiality.
The comprehensibility of the items descriptions was assessed through a 4-point Likert scale in the questionnaire (1. not understandable; 2. it requires a major revision to become understandable; 3. understandable but requires minor revisions; and 4. completely understandable) in addition to an open field for suggestions for improving the tool. The interrater agreement regarding the comprehensibility of the items was determined using the content validity index (CVI) computed as the number of scores of 3 and 4 for a question divided by the total number of scores for that question (CVI = number of scores of 3 or 4/ total number of scores). A minimum CVI of 90% was considered acceptable.16
Questions with a CVI < 90% and those requiring major or full revisions (according to the suggestions) were reframed and resent to the same judges for a new evaluation of their comprehensibility (with the following options: 1. Yes, the item is understandable; 2. No, major improvements are still needed to make the item understandable). The CVI of the new evaluation was then recalculated as the number of positive responses divided by the total number of responses. The items that maintained a CVI < 90% were removed from the tool.
In the relevance and applicability evaluation stage, we used the modified tool with its adjusted content (based on the suggestions obtained at the comprehensibility stage). We asked the judges whether they considered the items that comprised the tool relevant and applicable to each age group (children/ adults) and to which diseases they considered them relevant. Items that failed to reach 90% interrater agreement regarding their relevance were excluded from the tool.
All tests were performed considering a p-value of 0.05 and a 95% confidence interval (CI) using software R1 or IBM SPSS Statistics for Windows, version 25 (IBM Corp., Armonk, N.Y., USA).
Results
The data collection period was approximately four months. There were 28.5% losses in the first comprehensibility data collection phase (12 of the 42 sent links were lost) and 10% losses (3 of the 30 sent links were lost) in the item revision phase. However, the losses in the latter phase were not replaced because only the judges who answered the initial questionnaire were asked to revise it after the changes, and they were not replaced by different judges. Ultimately, the final revision was performed by 27 judges. The results have been divided into comprehensibility and relevance. In the relevance stage, there were 44% losses (23 of the 52 sent links were lost), due to either non-acceptance of the response or non-completion of the questionnaire (Figures 1 and 2). In this stage we admitted one loss because the stipulated time for the data collection was finished, and so no other judge was recruited.
Flowchart of the sample of professionals who evaluated the tool for its semantic comprehensibility in the first phase of this stage.
Flowchart of the sample of professionals who evaluated the tool for its relevance and applicability.
Stage I - Comprehensibility
Three codes and qualifiers descriptions (4.8%) were considered completely comprehensible by 100% of the judges, and only five (8.1%) were considered completely comprehensible by less than 80% of the judges.
Only item b4202 — Blood Pressure Functions — had a CVI lower than 90% (Table 1). All the other items had an adequate CVI, although the vast majority received suggestions for improvements. The five items that were considered completely comprehensible by less than 80% of the judges were reviewed, as were two others that received important suggestions that would considerably improve their comprehensibility, according to the group.
Items and content validity indices (CVI) regarding the comprehensibility of the items of the first version of the questionnaire
The judges mainly suggested clarifying terms or instructions and questioned the main differences between qualifier magnitudes, proposing ways to improve clarity. Suggestions for adjusting the language of the ICF or changing the way of applying the standardized tests used as a reference were not accepted, nor were those that would reduce the scope of the item to a small portion of the target population. This is because such changes would often lead to a failure to meet the percentages indicated by the WHO in generic qualifiers. The adjustment of one of the codes according to the judges’ suggestions is exemplified in Table 2. The other adjustments are shown in the supplementary information (in Portuguese), as authors agreed that a simple translation would not be accurate for the validated content (Appendix 1).
Demonstration of the analysis of suggestions and changes made to the selected codes exemplified for item b260 — Proprioceptive function
The reviewed items, including the item with a CVI < 90%, were reframed and resubmitted in a new questionnaire. Specifically, these items were b1266 - Confidence, b260 - Proprioceptive Function, b4202 - Blood Pressure Functions, b4551 - Aerobic Capacity, b7602 - Coordination of Voluntary Movements, d198 - Learning and Applying Knowledge, Other Specified, and d4106 - Shifting the Body's Center of Gravity. Please note that for one of the questions, the suggestion was to add a visual scale to facilitate patient response, and although we found it pertinent, the online form did not allow us to add images; therefore, the suggestion was not proposed but will be applied in the final version of the tool. These items were evaluated by 27 judges, and all of them reached the desired minimum CVI in this round.
Stage II - Relevance
Of the items presented, 40 were considered relevant for both populations, and 30 were considered relevant by 100% of the judges. The items relevant to each population and the differences in scores and their percentages between internal and external judges can be assessed in the supplementary material (Appendix 2).
For the adult/elderly population, of the 62 items, 55 codes (88.7%; CI - 82.3%–96.3%) were considered relevant by 90% or more judges. The seven non-relevant codes were b1266 - Confidence, b1268 - Temperament and personality functions, other specified, d4102 - Kneeling, d4108 - Changing Basic Body Position, d4552 - Running, d4553 – Jumping, and d4558 - Moving Around, Other Specified.
For the pediatric population, of the 62 items under analysis, 47 codes (75.8%; CI - 66.1 – 86.4%) were considered relevant by 90% or more of the judges. The 15 non-relevant codes were b260 - Proprioceptive Function, b265 - Touch Function, b2801 - Pain in Body Part, b289 - Sensation of Pain, b4202 - Blood Pressure Functions, b4352 - Functions of Lymphatic Vessels, b4550 - General Physical Endurance, b4551 - Aerobic Capacity, b4552 - Fatigue, b7401- Endurance of Muscle Groups, b7602 - Coordination of Voluntary Movements, d220 – Undertaking Multiple Tasks, d4105 - Bending, d4701 - Using Private Motorized Transportation, and d4702 - Using Public Motorized Transportation.
Considering the differences in codes deemed relevant between the adult/elderly and pediatric populations, we divided the tool, thus obtaining two similar assessments, albeit more specific for each age group. The summary of the tools obtained following the content validity process is shown in Figure 3, and the complete tools are provided in a supplementary material available on the journal website. The complete tool is in Portuguese, as authors agreed that a simple translation would not be accurate for the validated content.
Flowchart of the steps taken with findings summarizing the modified International Classification of Functioning, Disability and Health domains.
Discussion
This study aimed to validate the content of a tool based on the ICF codes and qualifiers, designed for physiotherapeutic functional assessment of individuals with physical disabilities throughout the patient rehabilitation process. We obtained two similar tools, one for adult/elderly and other for pediatric population, which correlated the ICF with clinical practice, covered a vast and diverse population and showed a valid content, providing functioning data of the population with physical disabilities in the rehabilitation.
The process of establishing the validity of a clinical tool is continuous and multifaceted. This article is the first to describe the validation of comprehensibility and relevance of a tool that operationalizes the use of ICF codes and adapted qualifiers with validated content for population from different age groups with physical disabilities in general. This achievement is very relevant for clinical practice, concerning not only the therapeutic process but also the patient community participation.
Our results showed a striking interrater agreement from the item comprehensibility stage, even among the external judges who had not previously acknowledge the tool. This high agreement indicates that the concept and its ratings are comprehensible and are applicable by physiotherapists in this population.
The main disagreements were related to ICF nomenclature and descriptions of each item. We believe that this difficulty can be attributed to the lack of knowledge of ICF language, which were considered unusual and not very clear.20,21 We retained the original description to ensure that the tool remains faithful to the ICF language, and the physiotherapist identifies the main concept evaluated. Disagreements related to qualifier ratings were adjusted respecting the methods previously used to define item categorization.18,19
Regarding the relevance, we observed that most items were relevant for both populations. There were 55 and 47 items considered relevant for evaluating adult/elderly and pediatric patients, respectively, however, the items differed from each other, which required the adoption of different tools for each age group. The tools were slightly shortened in comparison to the initial proposal; nevertheless, despite the condensation, both remained long, which illustrates the challenge of physiotherapeutic rehabilitation in considering the wide variety of activities and functions when approaching a patient with a physical disability.
We observed that the items included in the two tools developed in this study mainly cover categories of the activities and participation component of the mobility chapter. These include changing/maintaining body position (d410 and d415), transferring oneself (d420), walking/moving around (d450 and d460), and hand and arm use (d445). Additionally, muscle power and tone functions (b730 and b735), mobility of joint functions (b710), and respiration function (b440) were included from the body function and structures component. These components and categories have been cited in other studies as the most frequently occurring in practical use and research in the area.22,23
To assure the relevance of the two tools created, we used the ICF Rehabilitation Set, that is, a list of codes created by WHO which is strongly recommended to be applied when reporting clinical data on the rehabilitation context).24 We were able to use 10 out of 30 rehabilitation categories from the ICF Rehabilitation Set, which is significant because the set was developed for all rehabilitation purposes, and our tool only addresses physiotherapy. Among the codes of the created tools, 60% are covered in the categories of the Rehabilitation Set such as d450 (we consider, in addition to d450 – Walking, the d460 - Moving around because they are part of the same construct), Sensation of Pain (b280), Exercise Tolerance Functions (b455), and Using Transportation (d470).
Our tools included codes other than those listed by the WHO, which are also not cited in other literature. These codes are quite specific to the rehabilitation process in clinical practice, therefore relevant for operationalizing the use of the ICF in rehabilitation clinics. These include d198 - Learning and Applying Knowledge, Other Specified, which is related to patient and family education regarding their understanding of and participation in the therapeutic process, and d1558 - Acquiring Skills, Other Specified, which is related to the skill that we specify as wearing and adapting to walking aids and prostheses. The items of child bonding and confidence in the therapist and environment (codes: b1268 - Temperament and Personality Functions, Other Specified and b1266 - Confidence, respectively) are also significantly relevant in the evolution of pediatric patients within the objectives defined in the clinic. The only environmental factor code included in the tool also appears to be relevant for both populations (code e1208 - Products and Technology for Personal Indoor and Outdoor Mobility and Transportation, Other Specified). It is very specific to the process of patients with physical disabilities in rehabilitation and clinical practice, and it is essential in therapeutic planning.
Recent studies that created and adapted scales based on the ICF for specific populations also used the components of body function and structures and activities and participation, corroborating ours.25,26 It is important to include codes related to the environmental factors’ component because of its wide influence on functioning, however, this component is still underused in our clinical practice. Other articles relating the ICF to outcome measure scales in the field of physiotherapy cite its importance when organizing the clinical practice and emphasize the use of qualifiers in goal setting.22,23,27,28
The study the most similar to ours regarding its proposal and methodology is Coelho et al.´s,29 who developed a similar process for patients with spinal cord injury based on the core sets of this disease, enriching the language of the qualifiers to improve response reliability. We ignore whether its psychometric properties have been validated this far.29 Kohler et al.30 already demonstrated that adapting the ICF generic qualifiers increases intra- and interrater reliability when compared with the original form, and we hope to continue the subsequent validation steps of this tool to assess the same effect. The next steps will be to validate the repeatability, reproducibility and sensitivity of the tools, and to encourage the replication of similar tools in other areas of the multidisciplinary team for an overview of the functioning of the individual with physical disability in rehabilitation.
The final questionnaires are robust and may be considered long. However, in practice, these questionnaires were developed to be applied one item at a time, according to the need of the therapeutic period. Also, for this reason, we did not use qualifiers 8 and 9 (not specified and not applicable, respectively) since all items would be applicable and specified.
We should consider some limitations for this study. Firstly, the tool was considerably long and, although the judges contributed very significantly for its validation, we cannot discard the occurrence of evaluation fatigue bias due to its extension, even if any of the responses indicated such manifestation. Secondly, the judges did not necessarily have knowledge on the ICF, as they were expected to evaluate the clinical practice feasibility. We could still consider a fourth judge population of ICF experts to focus on the qualifiers adaptations and stablished magnitudes to continue to enhance the tools. They could also be further improved by adding more codes from the component of environmental factors to provide patients a broader view within their biopsychosocial context.
The present study relies only on the content validity and applicability of the items to better detail the steps and discuss the items. Validation steps for reliability and sensitivity properties are under development.
Conclusion
The items showed highly satisfactory comprehensibility among experts in the field and significant relevance for the follow-up of individuals with physical disabilities. Hence, we provide two comprehensive tools for use in populations with physical disabilities of different age groups (one for adults/elderly and another for children) throughout their rehabilitation process. As ICF-based tools, these instruments enable a holistic approach to patients and follows the global trend of facilitating the generation of homogeneous and reliable data on functioning. The reliability and sensitivity of the tools must be assessed in the next validity stage.
Acknowledgements
The authors would like to thank the Association for Assistance to Disabled Children (AACD) for granting us time and resources to work on this project. Also, we would like to acknowledge Dra. Simone Carazzato, Gabriela da Silva Matuti, Clarissa Barros de Oliveira and all the research commission from the institution for instructions on methodological matters and manuscript revision.
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Appendix 1 Table presenting the items before and after their adjustments
Appendix 2 Relevance of the items presented to the judges, categorized as external and internal judges, indicating the items that were included in the final tool
1 - Adult/elderly instrument
2 - Pediatric instrument
Edited by
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Associate editor:
Ana Paula Cunha Loureiro






