Проверка и оценка применения Комплекса реабилитации МКФ: польская клиническая перспектива.

Introduction

According to the World Health Organization (WHO), rehabilitation has been recognized as an integral strategy to promote well-being and healthy living for people of all ages [ 1 , 2 ]. It contributes to reducing the effects of chronic diseases or injuries, accelerating the return to full health or achieving the maximum functional state possible [ 3 ].

In many social strategies, rehabilitation has been recognized as an investment that has an impact on minimizing the frequency and duration of hospitalizations or reducing the percentage of people who are temporarily or permanently incapacitated [ 4 ]. To optimally manage the rehabilitation process and improve the quality of rehabilitation services for patients, standardized data are needed on the actual functional problems of people who use rehabilitation services [ 5 – 7 ]. This is particularly important in the inpatient rehabilitation unit setting, where ongoing monitoring of a patient’s functional status from admission to discharge from the unit is essential, considering both therapeutic progress and possible failures [ 8 ].

It is therefore necessary to implement simple tools for daily use in practical clinical practice, which will make it possible to collect data not only on the state of health but also on the state of functioning of the population in different contexts. This opportunity is provided by the International Classification of Functioning, Disability and Health (ICF), which was developed in 2001 by the World Health Organization (WHO) [ 9 ]. The classification provides a comprehensive framework for describing health-related conditions. The system of recording an individual’s functional status in the form of a code makes the use of the ICF classification a universal, international language for communication among professionals in various health-related fields [ 10 ]. The ICF classification consists of more than 1,400 categories with which any health-related functional state can be described [ 11 ]. To increase the usefulness of the ICF classification in clinical practice, ICF Core Sets are being developed [ 12 ]. The ICF Core Set is a collection of the most relevant ICF categories used to describe functioning in specific conditions or clinical settings [ 13 ].

One of the categorical sets is the ICF Rehabilitation Set, and the Polish version was developed along with a reference guide [ 14 , 15 ]. The set describes the functional and disability status of adult patients receiving services at different stages of the rehabilitation process and in different forms (i.e., inpatient and outpatient) [ 16 ]. However, there is a paucity of studies validating the existing ICF Core Sets [ 17 ]. To date, reliability and relevance tests have been conducted for the Chinese and Japanese versions of the ICF Generic-30 Set [ 18 – 20 ]. The results show that further validation studies of different language versions are needed, especially from different perspectives, to increase the clinical utility of the Core [ 16 , 21 , 22 ].

Accordingly, the purpose of this study was to validate and evaluate the use of the ICF Rehabilitation Set in rehabilitation patients in clinical practice in southeastern Poland.

Methods

Study design and setting

This was a single-centre observational cohort study. The study was conducted in the tertiary care rehabilitation centre in southeastern Poland between January 2023 and February 2025. The study was registered in the clinical trial registry at ClinicalTrials.gov ( NCT06718036 ).

The tertiary care rehabilitation centre is a place providing inpatient rehabilitation services. The department provides multidisciplinary and comprehensive rehabilitation and care for patients in subacute and chronic conditions who require support in performing daily activities. The amount of therapy for people qualified for the study was 3.5 h per day and included: individual therapy with a physiotherapist, verticalisation with a physiotherapist, selected physiotherapy treatments, psychological therapy and speech therapy support.

Participants

The study included patients with the following diagnoses according to the International Classification of Diseases (ICD-10: I69- Sequelae of cerebrovascular disease; G80 - Cerebral palsy; G81 - Hemiplegia and hemiparesis; G82 - Paraplegia and quadriplegia; T90 - Sequelae of injuries of head; S14 - Injury of nerves and spinal cord at neck level; S24 - Injury of nerves and spinal cord at thorax level; G35 - Multiple sclerosis; M05 - Rheumatoid arthritis; M15– osteoarthritis; - M16 - Coxarthrosis; M17 - Gonarthrosis; M47 - Spondylosis; M54 - dorsalgia). Based on diagnoses patients were assigned to two groups of conditions: neurological and orthopaedic diseases. The inclusion criteria for the study were as follows: age 18 years and older; the presence of chronic diseases, including neurological and orthopaedic conditions; the ability to answer questions reliably and honestly (abbreviated mental test score ≥ 6); the ability to participate in the inpatient rehabilitation process; and the ability to consent to participate in the study. The exclusion criteria for the study were as follows: aged 65 years and older; had fresh fractures; and had severe systemic diseases that prevented the study, such as acute illness exacerbation of chronic diseases or infections. Patients admitted to the rehabilitation department who provided written and informed consent to participate in the study were included. After the inclusion and exclusion criteria were applied, 207 patients were eligible for the study. No data were lost in the study sample. The number of subjects required for validation was determined in accordance with the recommendations of Anthoine et al. [ 23 ].

Data collection

Basic sociodemographic data (sex, age, body mass, height) were collected during the study. Body mass index (BMI) was calculated as weight in kg divided by height in metres squared and classified according to World Health Organization categories [ 24 ]. The disease was diagnosed on the basis of medical records, and a medical examination based on the ICD-10 was performed on the day the patient was admitted to the department [ 25 ].

ICF assessment

The Polish version of a rating reference guide for the ICF Rehabilitation Set was previously published [ 15 ]. The ICF Rehabilitation Set consisted of 29 categories, including 8 categories assessing Body Functions, 16 categories assessing Activity and Participation and 5 categories assessing Environmental Factors. Ratings of the three components of the classification were quantitatively assessed with qualifiers using the same scale denoting the severity of the problem, the magnitude of the impairment or the degree to which an environmental factor is a barrier on a scale of 0 to 4 (Table 1 ). The range of assessment of the individual components of the ICF Rehabilitation Set follows the scale proposed by the WHO [ 9 ]. The evaluation of qualifiers was based on the rating reference guide for categories of the ICF Rehabilitation Set [ 15 ].

Clinical assessment

The Barthel Index (BI) was also used to assess functional status. The index looks at 10 aspects: eating; moving around; maintaining personal hygiene; using the toilet; washing/bathing the entire body; moving on flat surfaces; climbing and descending stairs; and controlling stool and urine. The total score ranges from 0 to 100 points, with higher scores indicating greater functional independence [ 26 ]. Among the various tools for assessing functional independence, the BI is a well-established measure of patient-centred outcomes. It is also the most commonly used instrument in the rehabilitation unit setting to assess patients at admission and discharge [ 27 ].

Measurement implementation

An interdisciplinary team of specialists from the rehabilitation department participated in the evaluation of patients. The team consisted of medical rehabilitation and internist physicians, physiotherapists, nurses and a psychologist, among others (total of 8 people). Members of the team, after the initial and final diagnostics, attended a meeting at which final qualifier values were determined. The initial assessment of patients was conducted within 2 days of admission to the rehabilitation centre and 2 days before leaving the unit.

Statistical analysis

Statistical analysis was performed in R software, version 4.4.3. The number and percentage (%) of categorical variables or the mean ± standard deviation (SD) of measurable variables were used for the initial data analysis. P < 0.05 was considered to indicate statistical significance.

Disability Index

The Disability Index (DI), developed by Olivier et al., was used to assess the severity of the problem in each ICF category [ 28 ]. The index was calculated by summing the qualifiers in each component of the ICF category and then presented as a percentage of the problem in each subject. To facilitate interpretation of the index, the sum of qualifiers is divided by the maximum value possible in a given component and then multiplied by 100. The resulting numerical value, ranging from 0 to 100, indicates the percentage extent of the problem a person has in each category. The higher the score is, the greater the extent of the problem [ 29 ].

Reliability

To assess the intra- and interrater reliability of the ICF codes, the type 2 intraclass correlation coefficient (ICC) (according to Shrout and Fleiss) was used. ICC values between 0.75 and 0.90 indicate good reliability, and values of 0.90 and above indicate excellent reliability [ 30 ].

The repeatability of the ICF Rehabilitation Set assessments was evaluated using the test‒retest method. The time between the two measurements was 2 days. The concordance of assessments between two clinicians was also assessed using test–retest methods.

The standard error of measurement (SEM) was used to measure absolute reliability. The determination of the absolute reliability of measures is critical to ensure repeated measurements with satisfactory stability and sensitivity to real changes over time [ 31 ]. The absolute reliability indicates how much dispersion and error this measurement contains [ 32 ]. In addition, the minimal detectable change (MDC) was calculated. The MDC estimates the minimal amount of change in the score that confirms the change is truly free from measurement error.

Convergent validity

Convergent persistence was assessed by correlating the DI with the BI. Spearman’s correlation coefficient was used to assess the correlation between the DI and the BI.

Effects of rehabilitation

To assess the effects of rehabilitation, the paired Wilcoxon test was used to compare two repeated measures of ICF codes.

Results

A total of 116 men and 91 women participated in the study. The mean age in the study group was 55.53 years (SD = 18.92 years). Most of the subjects were patients with neurological conditions. The characteristics of the study group are shown in Table 2 .

Reliability analysis

Internal consistency

Temporal consistency was estimated using the test‒retest method with the intraclass correlation coefficient (ICC). For this purpose, 24 subjects were retested 3 days apart using the ICF Rehabilitation Set. The ICC coefficient was high and very high (from 0.793 to 1.000), indicating very good concordance of the results from Test 1 compared with the results of Test 2. The results obtained are shown in Table 3 .

The reference guide for the ICF Rehabilitation Set has been shown to be consistent and reliable. Measurement consistency was demonstrated between two clinicians who used the ICF-based tool to assess patients undergoing the rehabilitation process. The ICC values ranged from very high (for B620; D450; D640, the ICC was 1.000) to high (for E155, it was 0.793). When the DI was evaluated, the ICC was 0.995, confirming that the individual codes from the ICF Rehabilitation Set have very high concordance with the evaluation of individual qualifiers among researchers (Table 4 ).

The resulting DI score had a low measurement error (SEM = 0.05). The minimal detectable change in DI was 0.13 (Table 5 ).

Convergent validity

Convergent validity was checked by correlating the scores obtained with the ICF Rehabilitation Set and the calculated DI with the BI score. The DI score correlated negatively with the BI score, meaning that the higher the DI score was, the lower the BI score was ( p < 0.001). The results indicate that the ICF Rehabilitation Set is sensitive to changes in the functional status of patients undergoing rehabilitation and is consistent with the BI measurement scores.

The results obtained are shown in Table 6 ; Fig. 1 a and b.

Effects of rehabilitation

As a result of the rehabilitation, statistically significant improvements were shown in all codes for Body Function and Activity and Participation, the DI was lower, and the BI scores were significantly greater ( p < 0.001). The mean change in the DI score after rehabilitation was 9.38 (SD = 3.21), whereas the BI score was 9.30 points (SD = 0.04) (supplemental material).

Figure 2 shows the effects of rehabilitation on the basis of average qualifier scores for each ICF Rehabilitation Set code.

Discussion

The study resulted in the first validation and evaluation of the use of the ICF Rehabilitation Set for collecting health information about patients undergoing rehabilitation. The ICF Rehabilitation Set was shown to be reproducible, consistent, sensitive to changes and relevant. The DI calculated from each ICF Rehabilitation Set category was significantly correlated with the BI scores both before and after rehabilitation.

Clinical practice and reporting of a patient’s functional status require a simple.

and universal health data collection tool. To facilitate the application of the ICF Rehabilitation Set, a rating reference guide was developed for Body Function, Activity and Participation, and Environmental Factors [ 15 ]. Creating a tool to assess patients, both in clinical settings and for research purposes, should include an assessment of psychometric properties, such as reliability and accuracy [ 17 ].

The rating reference guide for the ICF Rehabilitation Set used in the study is reproducible, both over time and between evaluating clinicians. The results of the study revealed good to excellent reliability of the tool for all ICF categories (ICC from 0.793 to 1.000). The descriptions proposed in the tool and the way the ICF qualifiers are assessed are reproducible, which means that two different rehabilitation professionals similarly assess the same patient and therefore understand the code definitions in the same way.

Similar results were obtained by Senju et al. [ 18 ], who reported moderate to excellent reliability for the nine Body Function categories from the ICF Generic-30. The weighted kappa coefficient ranged from 0.53 to 0.78. Additionally, for the Japanese version of the ICF Generic-30 Set and the rating reference guides, Mukaino et al. reported substantial to excellent agreement among the evaluated clinicians. The weighted kappa statistics ranged from 0.61 to 0.85 [ 19 ]. Liu et al. reported that the ICF Generic-6 is a reliable and relevant tool for collecting information on the functional status of patients in various clinical settings. The ICCs of the core set items evaluated ranged from 0.67 to 0.87 [ 20 ].

According to research, the use of ICF-based tools without definitions and guidance on how to assess individual qualifiers has low reliability [ 33 ]. In contrast, the use of a simple and defined rating scale makes these tools easy to use and reliable [ 34 ].

In our study, among patients who participated in the rehabilitation process, the obtained DI score, which was calculated from the individual categories of the ICF Rehabilitation Set, had a low measurement error (SEM = 0.05), and the MDC was 0.13. The MDC score is considered an estimate of the reactivity of the measure [ 35 ]. Information regarding MDC describes the smallest amount of change in the score that is perceived by patients as significant. Comparing our results with other data is difficult, as, to our knowledge, this is the first report of minimal detectable changes in the ICF Rehabilitation Set.

We also tested convergent validity by correlating the scores obtained with the ICF Rehabilitation Set and the calculated DI with the BI scores. The DI score was negatively correlated with the BI score. Functional independence assessed by the BI is an important measure commonly used in the health care sector [ 36 ]. According to Jonsdotia et al., the ICF Generic-6 was significantly associated with a measure of functional independence in patients undergoing rehabilitation [ 37 ].

The study revealed that the ICF Rehabilitation Set was adequate for capturing changes in functional status after rehabilitation. The average change in the DI score after rehabilitation was 9.38, while the BI score was 9.30 points. Jonsdotii et al. reported that the ICF Generic-6 is moderately sensitive to changes in patients’ health status after rehabilitation. The authors obtained moderate sensitivity accuracy with the BI score [ 37 ]. Additionally, Kinoshita et al. reported that improvements in functional status assessed with the ICF rehabilitation set were significantly correlated with changes in scores obtained on the Functional Independence Measure (FIM). The authors indicate that ICF-based health information data can be used to detect changes in function and disability in patients undergoing poststroke rehabilitation [ 22 ].

Practical implications

In view of the WHO’s recommendations for the implementation of the ICF in the health care system in Europe and the world, the results obtained in our study represent the first recommendations for the effectiveness of using the ICF Rehabilitation Set in clinical practice in Poland. The developed rating reference guide for the ICF Rehabilitation Set is reproducible, relevant and sensitive to changes in functional status in patients receiving.

rehabilitation. The developed tool can be incorporated into the basic evaluation of rehabilitation outcomes in routine clinical practice. The use of the ICF Rehabilitation Set in the Polish health care system as one component of the evaluation would enable the collection of relevant information about the functional status of individuals with various functional deficits across the continuum of care, enabling comparisons of patients’ functional profiles on a timeline. This type of evaluation of the health status of people undergoing rehabilitation is particularly important to ensure proper management of the rehabilitation process, the application of appropriate improvement procedures, and the standardization of health information across the entire period of disability, across health conditions, and between institutions, countries and cultures [ 21 , 37 ].

Limitations of the study

Our study has some limitations. Firstly, groups of patients with cardiological and pulmonary diseases were not analysed in the study. The study included only patients with neurological and orthopedic conditions. However, these groups of patients make up the majority of patients undergoing inpatient rehabilitation. Secondly, the method of group selection limits the representativeness of the study, as the participants were from only one tertiary care rehabilitation center in southeastern Poland. To increase process of validation, further studies with a more diverse group of patients and in different rehabilitation settings are needed.

Conclusions

The ICF Rehabilitation Set and developed rating reference guide is reproducible, consistent and relevant and can be used in clinical settings to collect health information from people undergoing rehabilitation. Further research is needed to evaluate the utility of using an ICF-based tool in clinical practice in different contexts and populations. Further research is needed to strengthen the evidence to validate the tool and enhance the implementation of the ICF in Poland.

Supplementary Information

Supplementary Material 1.

Acknowledgements

The authors would like to thank all participants for their participation and commitment in the study.

Abbreviations

International Classification of Functioning Disability and Health

Intraclass Correlation Coefficients

Barthel Index

Disability Index

World Health Organization

10-International Classification of Diseases

Standard Deviation

Standard Error of Measurement

Minimal Detectable Change

value-Statistical significance

Authors’ contributions

AWS: Conceptualization, Data curation, Investigation, Methodology, Project administration, Resources, Validation, Visualization, Roles/Writing—original draft. Prepared Figs. 1a and b and 2; Tables 1, 2, 3, 4, 5 and 6, supplemental material, Writing—review & editing. AS: Supervision, Writing—review & editing. JB: Data curation, Writing—review & editing. BS: Formal analysis, Writing—review & editing. AWP: Supervision, Writing—review & editing. The authors read and approved the final manuscript.

Funding

This research received no external funding.

Data availability

Data supporting this study are available from University of Rzeszow Repository at https://repozytorium.ur.edu.pl/handle/item/11488.

Declarations

Ethics approval and consent to participate

The study was conducted in accordance with the principles of the Declaration of Helsinki. All subjects were informed about the purpose and procedure of the study and gave their informed consent to participate in it. Before the study began. its project received a positive opinion from the Bioethics Committee of the University of Rzeszów (No. 2023/06/0035).

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.

Footnotes

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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Associated Data

Supplementary Materials

Supplementary Material 1.

Data Availability Statement

Data supporting this study are available from University of Rzeszow Repository at https://repozytorium.ur.edu.pl/handle/item/11488.