Application of the functional capacity scale in the early assessment of functional efficiency in patients after aneurysm embolization: Preliminary reports

Background. While data on the long-term (e.g., 1 year and subsequent years) outcomes of intracranial aneurysms treatment is relatively well-documented mainly in the clinical aspect (comparability of treatment, mortality, and complications), little is known about the early results, in terms of the functional outcome. Objectives. The aim of the study was to analyze the use of Functional Capacity Scale (FCS) in the evaluation of patients in the early period after endovascular treatment of intracranial aneurysms. Material and methods. The study was conducted in the Neurosurgery Clinic, University Hospital Col-legium Medicum in Bydgoszcz, on a group of 118 consecutively admitted patients with the diagnosis of intracranial aneurysm, qualified for treatment using the endovascular method (embolization). The assessment was performed twice. In the clinical assessment the Glasgow Coma Scale (GCS) was used to evaluate the level of consciousness and the Hunt and Hess Scale (H&H) to assess the patient’s condition. To assess the final outcome and early functional capacity Glasgow Outcome Scale (GOS), Barthel Index (BI), Modified Rankin Scale (mRS) and the new Functional Capacity Scale were used. Results. The assessment performed with the FCS was comparable to the assessment conducted with standardized tools such as BI, mRS or GOS. The clinical condition assessed with the GCS (p < 0.001) and H&H (p < 0.001) differentiates the functional condition assessed using the FCS. Statistically significant correlations were found between FCS and BI (r = -0.78), GOS (r = -0.69) and mRS (r = 0.68). Conclusions. The study indicates that the FCS correlates with other scales used in the assessment of patients with intracranial aneurysm, which means that the proposed tool can be applied successfully in practice. However, further randomized multicenter studies are necessary in order to clarify the final conclusion

The death rate caused by SAH from ruptured intracranial aneurysm decreased in the recent decades by ca.17% and the overall survival rate amounts to ca. 65%. 1,2][5] While the data on long-term results (i.e. after a year and longer) of intracranial aneurysm treatment are fairly well documented [6][7][8][9] , mainly from the clinical aspect (comparison of treatment methods, mortality, complications occurrence), there is a lack of data on early results from the functional aspect.The immediate period following the procedure (time until the patient's discharge) is particularly dangerous for the patient due to the possibility of various complications appearing that may affect his or her functional capacity.A well-performed early functional assessment may provide prognosis regarding long-term results.
Research carried out for many years showed that one of the most important factors conditioning the result of treatment, as well as the functional result of patients with aneurysm (with/without SAH), is the patient's clinical condition (including consciousness level) prior to treatment.][15] The main aim of the study was to analyze the performance of the Functional Capacity Scale (FCS) in the assessment of patients in the early period following the endovascular treatment of intercranial aneurysm.Possible correlations between the scales used for the assessment of the functional condition of a patient were investigated.Moreover, an attempt was made to determine whether clinical condition assessed with the Glasgow Coma Scale and the Hunt and Hess Scale provide similar results to the Functional Capacity Scale, Barthel Index, Modified Rankin Scale and the Glasgow Outcome Scale.

Setting and sample
The study was conducted at the Neurosurgery Clinic of the University Hospital Collegium Medicum (CM) in By-  The study involved patients admitted with a diagnosed intracranial aneurysm and qualified for endovascular treatment (embolization).The patients chosen for the study had to meet the following criteria: 1) be diagnosed for intracranial aneurysm and 2) undergo a successful embolization procedure (for the first time) 3) with no fatal complications.The criteria that eliminated a patient from the study included: 1) being diagnosed with more than 1 intracranial aneurysm (consecutive aneurysm) or other vasal anomaly (i.a.arteriovenous angioma), 2) having undergone consecutive and/or unsuccessful embolization or surgery procedure (clipping, wrapping, trapping), 3) fatal complications.Among the 118 patients there were 73 women and 45 men.The age of the patients ranged from 18 (the youngest) to 82 (the oldest).The average age was 51.4 ± 11.4, with patients of age 50-64 being the most numerous group.All the patients were hospitalized for intracranial aneurysm and all of them underwent an embolization procedure.Seventy-six patients were diagnosed with ruptured aneurysm (with subarachnoid haemorrhage -SAH), and 42 were suffering from non-ruptured aneurysm (i.e.cold).The aneurysm was usually located in the complex of the anterior communicating artery (42 persons) and the internal carotid artery (33 persons).The average time preceding the embolization procedure was 43 h.The largest number of patients (85) underwent embolization up to 24 h after having been admitted to the ward (Table 1).

Instruments
The study involved a two-time assessment.The first assessment (measure 1 -prior to the procedure) was conducted on the first day of patient's hospitalization.The clinical assessment involved the use of the Glasgow Coma Scale (GCS) to measure the patient's level of consciousness, and the Hunt and Hess Scale (H&H) to assess the patient's condition. 10,11The second assessment (measure 2 -after the procedure) was carried out on the day of the patient's discharge from the ward.[15][16][17]

Ethical considerations
The study obtained the consent of the Bioethics Commission of the Nicolaus Copernicus University in Toruń at Ludwik Rydygier Collegium Medicum in Bydgoszcz (KB no.297/2008, no.291/2013, and no.564/2014).

Data analysis
The statistical analysis was conducted with the Microsoft Excel programme (licence CM NCU LOGON S.A., Bydgoszcz, PL) and STATISTICA v. 10.0.(licence CM NCU, StatSoft, Kraków, PL).The analysis of conformity of quantitative variables to normal distribution was carried out with the Shapiro-Wilk test.Following the accepted parameters in biomedical sciences, unless stated differently, the results were acknowledged as statistically significant at a value of 0.05.The analysis used the Kruskal-Wallis non-parametric Anova test and a post-hoc test to determine any statistically significant differences between the assessment of the patient's consciousness level (GCS) and his or her clinical condition (H&H), and the patient's functional capacity after treatment.Moreover, the study involved the use of Spearman's rank correlation coefficient (r S ) to indicate the relationship between its value and the individual tools used to assess the patient's functional capacity (FCS, BI, mRS and GOS).

Results
On the day of the patient's discharge from the ward (Table 2), in accordance with the FCS classification adopted, the largest number of patients was found in group I (98 persons -83%).This means that the early results regarding the functional capacity in the analysed group are successful.The fact is further confirmed by the results obtained with the standardized functional scales.The BI identified 93 persons as "able" (BI group V and IV).Similarly, the mRS estimated the number of people in good condition to 89 (mRS group 0 and 1).The Glasgow Outcome Scale, on the other hand, qualified 99 persons to group 5 and 4, indicating satisfactory result of treatment.
Furthermore, we analysed the influence of the consciousness level according to the GCS scale and clinical condition in the H&H scale (prior to the procedure) on the patient's functional capacity after receiving endovascual treatment of aneurysm as assessed with the functional scales (FCS, BI, mRS, GOS).The value of test statistics in the analysis of the influence of consciousness level (GCS) on the patient's functional capacity (Table 3) is statistically significant at p < 0.001.Statistically significant differences among all the analysed groups in accordance with the FCS, BI, mRS and GOS scales were found, which means that patients with a higher level of consciousness obtained better functional result.Similarly, the patient's clinical condition prior to the procedure assessed with the H&H (Table 4), significantly (p < 0.001) differentiated functional capacity after the procedure; thus, the patients in better clinical condition obtained better functional result.
Individual tools for the functional assessment were compared (Table 5).Each case provided a statistically significant value of the Spearman's rank correlation coefficient in the range from 0.68 to -0.88.The highest coefficient in the correlation analysis with the FCS was obtained for the BI (r S = -0.78),and the lowest for the mRS (r S = 0.68).A comparison of the remaining scales' correlations showed the highest coefficient (r S = -0.88)for the GOS and mRS.Thus, there is a relationship between the FCS results and the results obtained with each individual scale (BI, mRS, GOS), which means that they influence one another in a statistically significant ways; hence, they are mutually dependant.x -average; SD -standard deviation; Me -median; range -range of points for the scale.

Discussion
The study involved an early assessment of functional capacity in patients with intracranial aneurysm treated by means of endovascular embolization.The authors believe this is the first such study regarding early-term results from the point of view of functional assessment, which is particularly significant for making prognoses on long-term results (e.g.3-6-12 months after the procedure).Apart from the applied standardized functional scales (BI, mRS, GOS), the results were supplemented with the proposed FCS scale. 17he research tools used in the study consisted of the most popular and reliable scales applied in the assessment of patients with aneurysm and SAH.It was confirmed by Al-Khindi et al. 18 , who presented a literature review on Cognitive and Functional Outcome After Aneurysmal In most cases the functional assessment is carried out alongside multicentre trials, such as the International Subarachnoid Aneurysm Trial (ISAT) [6][7][8] and the Barrow Ruptured Aneurysm Trial (BRAT) 9 , which feature very long monitoring periods but are predominantly oriented towards comparing the results of intravascular and surgery treatment with respect to mortality and compilations occurrence.
One of the main factors that affects the results of treatment in patients suffering from intracranial aneurysm is their clinical conditions prior to the treatment [19][20][21] .The majority of the conducted analyses indicate that the clinical condition and the level of consciousness of patients on the day of admission constitute an independent prognostic factor for long-term results of treatment.
The presented material shows a significant relationship between the clinical condition assessed with the use of the H&H and the patient's consciousness level assessed with the GCS on the day of admission, and the functional result of discharge.Both the H&H and GCS scales showed that the more severe condition upon patients' admission translated into worse functional capacity upon their discharge, which was confirmed with three different measuring instruments (mRS, BI and FCS).
The research by Haug et al. 22 showed that 1 in 5 patients admitted to hospital after SAH in coma recover without any marked neurological deficits and cognitive functions disorders.Van Heuven et al. 23 , on the other hand, indicated that patients who are admitted to hospital and give no verbal or motor response have a 5% chance to recover and function independently.
Our study showed statistically significant correlations between the applied functional scales, which is confirmed in the research conducted by other authors who  Subarachnoid Hemorrhage.In the opinion of the authors, patients after SAH tend to experience memory deficit, as well as a decline in executive and language functions.Cognitive disorders affect everyday functioning, employability and the quality of life.
use various measuring instruments in clinical (Hunt and Hess Scale, World Federation of Neurological Surgeons Scale, Glasgow Coma Scale, Fisher Scale) 7,24,25 and functional assessment (Barthel Index, Rankin Scale, Glasgow Outcome Scale, SF-36) 26,27 carried out both in the early and late period after the treatment of intracranial aneurysm.

Conclusions
The study shows that the FCS correlates with other scales used in the assessment of the condition of patients with intracranial aneurysm, which means that the proposed tool can be used in practice.
The clinical condition and consciousness level of a patient before the procedure constitutes a factor that differentiates his or her functional condition after the procedure.
The FCS should be further subjected to multicentre randomized research in order to provide more detailed conclusions.

Table 1 .
Demographic data regarding the study participants N (%)

Table 2 .
Condition on the day of discharge (after the procedure) N (%)

Table 3 .
Dependency of functional capacity (FCS, BI, mRS, GOS) from the level of consciousness (GCS)

Table 5 .
Results of Spearman's rank correlation analysis