81 ORIGINAL SCIENTIFIC ARTICLE Reliability and validity of the Slovenian Translation of the Functional Oral Intake Scale (FOIS-SI) Copyright (c) 2022 Slovenian Medical Journal. This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. Reliability and validity of the Slovenian Translation of the Functional Oral Intake Scale (FOIS-SI) Zanesljivost in veljavnost lestvice funkcionalnega peroralnega vnosa (angl. Functional Oral Intake Scale, FOIS-SI) v slovenskem prevodu Barbara Vogrinčič,1 Klara Trpkova,1 Fajko Bajrović1,2 Abstract Background: It is crucial that each and every stroke patient gets a systematic assessment of swallowing disorders, per- formed by a dysphagia specialist. Therefore, there is a need to use a standardized scale among professionals. The aim of this study was to translate, adapt, and obtain the statistical characteristics of the Functional Oral Intake Scale (FOIS), which is an observer-rated dysphagia severity scale primarily developed for stroke patients, into the Slovenian language. Methods: We performed a 5-step translation and adaptation process. Six speech and language pathologists had evaluated 30 clinical records of patients with an acute ischemic stroke in the carotid artery territory with the Slovenian translation of the Functional Oral Intake Scale (FOIS-SI). Every clinical record included a speech and language clinical bedside assess- ment of dysphagia, the sex, age, National Institutes of Health Stroke Scale (NIHSS), comorbidities of patients and lesion location. We examined interrater and intrarater reliability and additionally convergent validity of FOIS-SI with the theoret- ically related IDDSI-Functional Diet Scale (IDDSI-FDS). Results: The average measure Intraclass Correlation Coefficient (ICC) for the interrater reliability (ICC=0.959) and the intr- arater reliability (ICC=0.979 and ICC=0.991) for both raters was excellent. The FOIS-SI scores correlated very high with the IDDSI-FDS (rs=0.927). Conclusion: The results of this study show that the Slovenian translation of the FOIS has an excellent interrater and intra- rater reliability and very high validity, which implies the FOIS-SI can be used as a tool to quantitatively assess the severity of dysphagia in clinical practice and research in patients with stroke in carotid artery territory across the country in all medical and care settings. Slovenian Medical Journallovenian Medical Journal 1 Division of Neurology, University Medical Centre Ljubljana, Ljubljana, Slovenia 2 Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia Correspondence / Korespondenca: Barbara Vogrinčič, e: barbara.vogrincic@kclj.si Key words: dysphagia; rehabilitation; IDDSI; speech and language pathologist; ischaemic stroke Ključne besede: disfagija; rehabilitacija; IDDSI; logoped; ishemična kap Received / Prispelo: 6. 10. 2020 | Accepted / Sprejeto: 26. 11. 2020 Cite as / Citirajte kot: Vogrinčič B, Trpkova K, Bajrović F. Reliability and validity of the Slovenian Translation of the Functional Oral Intake Scale (FOIS-SI). Zdrav Vestn. 2022;91(3–4):81–90. DOI: https://doi.org/10.6016/ZdravVestn.3167 eng slo element en article-lang 10.6016/ZdravVestn.3167 doi 6.10.2020 date-received 26.11.2020 date-accepted Neurology, neuropsychology, neurophysiology Nevrologija, nevropsihologija, nevrofiziologija discipline Original scientific article Izvirni znanstveni članek article-type Reliability and validity of the Slovenian Translation of the Functional Oral Intake Scale (FOIS-SI) Zanesljivost in veljavnost lestvice funkcionalnega peroralnega vnosa (angl. Functional Oral Intake Scale, FOIS-SI) v slovenskem prevodu article-title Reliability and validity of the Slovenian Translation of the Functional Oral Intake Scale (FOIS-SI) Zanesljivost in veljavnost lestvice funkcionalnega peroralnega vnosa (angl. Functional Oral Intake Scale, FOIS-SI) v slovenskem prevodu alt-title dysphagia, rehabilitation, IDDSI, speech and language pathologist, ischaemic stroke disfagija, rehabilitacija, IDDSI, logoped, ishemična kap kwd-group The authors declare that there are no conflicts of interest present. Avtorji so izjavili, da ne obstajajo nobeni konkurenčni interesi. conflict year volume first month last month first page last page 2022 91 3 4 81 90 name surname aff email Barbara Vogrinčič 1 barbara.vogrincic@kclj.si name surname aff Fajko Bajrović 1,2 Klara Klara Trpkova 1 eng slo aff-id Division of Neurology, University Medical Centre Ljubljana, Ljubljana, Slovenia Nevrološka klinika, Univerzitetni klinični center Ljubljana, Ljubljana, Slovenija 1 Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia Medicinska fakulteta, Univerza v Ljubljani, Ljubljana, Slovenija 2 82 NEUROLOGY, NEUROPSYCHOLOGY, NEUROPHYSIOLOGY Zdrav Vestn | March – April 2022 | Volume 91 | https://doi.org/10.6016/ZdravVestn.3167 1 Introduction Swallowing is a complex physiological process, in which the activity of 50 pairs of muscles is orchestrated by an extensive neuronal network in the central nervous system to intake food into the mouth, prepare it and transport it from the oral cavity through the pharynx to the stomach (1,2). This process can be disturbed in many ways, which can lead to malnutrition, dehydra- tion, and possibly death (3). Therefore, dysphagia is a common problem in all stages of swallowing. Accord- ing to our clinical experience at the University Medical Centre (UMC) Ljubljana in the last years, dysphagia ap- pears in 20% of stroke patients admitted for treatment to the Division of Neurology (unpublished clinical da- ta). Globally the percentage is higher, around 50% (4). In the diagnostic process of dysphagia, a full bedside clinical examination is of utmost importance before ob- jective methods, such as Videofluoroscopic Swallowing Study (VFSS) and Fiberoptic Endoscopic Evaluation of Swallowing (FEES), are eventually applied (5). Clinical swallowing bedside examination, VFSS, and FEES are mostly qualitative studies, which have limited options to precisely determine the severity of dysphagia. Yet, different follow-up methods for assessing dysphagia are also known to not be fully accurate. As a result, research- ers developed quantitative scales based on both, VFSS and FEES techniques (6,7). However, not all patients have access to objective techniques, especially patients in general practices or nursing care facilities (8). There- fore, different self-evaluating questionnaires and scales which could help clinicians to determine the severity of Izvleček Izhodišča: Pri bolnikih z disfagijo po ishemični možganski kapi v povirju karotidne arterije, ki jih obravnava specialist za disfagijo, je ključno sistematično vrednotenje stopnje disfagije. Zato strokovnjaki izražajo potrebo po uporabi standardi- zirane lestvice. Cilj raziskave je prevod in prilagoditev lestvice funkcionalnega peroralnega vnosa (angl. Functional Oral Intake Scale, FOIS), primarno sestavljene za bolnike po možganski kapi, ki je zdravnikom v pomoč pri vrednotenju izraže- nosti disfagije. Preverili smo tudi zanesljivost in veljavnost lestvice funkcionalnega peroralnega vnosa (FOIS-SI). Metode: Izveden je bil 5-stopenjski proces prevoda in prilagoditve. Šest izkušenih logopedov, ki se ukvarjajo z disfagijo, je ovrednotilo 30 kliničnih poročil bolnikov po ishemični možganski kapi v povirju karotidne arterije. Poročila so vsebovala klinično logopedsko obposteljno oceno disfagije, spol in starost bolnika, ter lestvico Nacionalnega inštituta za zdravje za oceno nevrološke prizadetosti po možganski kapi (NIHSS), pridružene bolezni in mesto spremembe. Na podlagi podatkov smo izračunali zanesljivost. Študija veljavnosti je bila izvedena z iskanjem povezave med FOIS-SI in lestvico izraženosti disfagije IDDSI-FDS. Rezultati: Zanesljivost med logopedi je bila odlična (ICC=0.959). Prav tako je bila odlična zanesljivost ob ponovnem vred- notenju (ICC=0.979 in ICC=0.991). V študiji smo zaznali zelo visoko korelacijo z IDDSI-FDS (rs=0.927). Zaključek: Rezultati študije so pokazali, da je slovenska različica FOIS izjemno zanesljiva ter zelo visoko veljavna, kar naka- zuje, da se FOIS-SI kot kvalitativno orodje za oceno izraženosti disfagije lahko uporablja v klinične in raziskovalne namene. dysphagia were developed. In Table 1 the characteristics of published and available swallowing scales are listed. Regarding dysphagia, only the questionnaire Quality of life in swallowing disorders (9) is translated and adapted to the Slovenian language. To compare the patient’s level of dysphagia and outcome, a Slovenian translation of the severity scale is still needed. Since the Functional Oral Intake Scale (FOIS) has good psychometric character- istics (10), correlates significantly with the Food Intake Level scale, swallowing time of the Functional Assess- ment Measure, Mass Assessment of Swallowing Ability, Modified Barthel Index score, modified Rankin scale, VFSS (11), is easy to use, was translated to and validat- ed in different languages (12-14), and was also used for different populations (11), and diseases (15-23), we de- cided to translate it and evaluate the initial psychometric characteristics of the Slovenian translation. FOIS was developed based on reviewing dyspha- gia-related literature. The most describable items of a pa- tient’s oral or compensatory intake of food and liquids, and its potential modification, were selected for the final scale form. The initial scale had 10 levels, but this num- ber was reduced to seven after the pilot study (10). 2 Methods This paper is part of a larger research about dysphagia outcome of stroke survivors in acute care, which was ap- proved by the National Medical Ethics Committee of the Republic of Slovenia (No. 0120-255/2029/3, 14.07.2020). 83 ORIGINAL SCIENTIFIC ARTICLE Reliability and validity of the Slovenian Translation of the Functional Oral Intake Scale (FOIS-SI) Sc al e (r ef er en ce ) Fu ll na m e Le ve ls Di re ct io n of se ve ri ty Re qu ir es a n ob je ct iv e as se ss m en t Po pu la tio n Re lia bi lit y an d va lid ity Re co m m en da tio ns DO SS (2 4) Dy sp ha gi a O ut co m e an d Se ve rit y Sc al e 7 Fr om 1 (s ev er e dy sp ha gi a - N PO ) t o 7 (fu ll pe r- or al n ut rit io n w ith n or m al d ie t) Ye s, m os tly VF SS Ad ul ts re pr es en tin g di ffe re nt di ag no se s ( ne ur ol og ic al , ge ne ra l m ed ic al , p ul m on ar y, ca rd ia c an d ea r, no se , a nd th ro at d ia gn os is ) In te rr at er 9 0% a nd in tr ar at er re lia bi lit y 93 % , n o va lid ity te st in g Di et le ve l, in de pe nd en ce le ve l, an d ty pe o f nu tr iti on . DS RS (2 5) Dy sp ha gi a se ve rit y ra tin g sc al e 0- 12 Fr om 0 (b es t) to 1 2 (w or st ) no Ad ul ts w ith p os t s tr ok e dy sp ha gi a. Co ns en su al v al id ity – m od er at e, co nt en t v al id ity – b et w ee n 0. 84 (g oo d) to 0 .9 6 (e xc el le nt ), co nc ur re nt c rit er io n va lid ity - s tr on ge r w ith m ea su re s o f sw al lo w in g an d as pi ra tio n, lo w er w ith g lo ba l m ea su re s o f im pa irm en t, In tr a an d in te rr at er re lia bi lit y w as > 0. 9 0. M od ifi ca tio n of fo od a nd fl ui d, su pe rv is io n re qu ire m en ts fo r fe ed in g. FI LS (2 6) Fo od In ta ke Le ve l S ca le 10 Fr om le ve l 1 (n o or al in ta ke – n o sw al lo w in g tr ai ni ng is p er fo rm ed e xc ep t fo r o ra l c ar e) to le ve l 10 (o ra l i nt ak e al on e – no d ie ta ry re st ric tio n, an d th e pa tie nt s in ge st s t hr ee m ea ls or al ly ) N o Di ffe re nt p rim ar y di se as es (c er eb ro va sc ul ar , re sp ira to ry , n eu ro m us cu la r, ne ph ro lo gi ca l, ca rd io ci rc ul at or y, au to no m ic d ys fu nc tio n ca nc er a nd c er vi ca l s pi ne in ju ry ) In te rr at er re lia bi lit y ra ng ed fro m 0 .7 0 to 0 .9 0 In te rr at er re lia bi lit y ra ng ed fro m 0 .8 3 to 0 .9 0. Co nv er ge nt v al id ity - hi gh ly as so ci at ed w ith F O IS (p =0 .9 6 -0 .9 9) De gr ee o f p at ie nt ’s in ta ke o f f oo d no n- or al ly o r o ra lly . FO SS (2 7) Fu nc tio na l O ut co m e Sw al lo w in g Sc al e 6 Fr om 0 (n or m al fu nc tio n an d as ym pt om at ic ) t o V (n on or al fe ed in g fo r al l n ut rit io n) ye s Fu ll sp ec tr um o f or op ha ry ng ea l d ys ph ag ia in a du lts , e sp ec ia lly a gi ng pa tie nt s a nd p at ie nt s w ith he ad a nd n ec k ca nc er , ne ur ol og ic d is or de rs , ga st ro es op ha ge al co nd iti on s, a nd p sy ch ia tr ic pr ob le m s. N o fo rm al st ud y. Ph ys io lo gi ca l fu nc tio n, w ay o f fe ed in g, n ut rit io na l an d re sp ira to ry st at us . Ta bl e 1: C ha ra ct er is tic s of d iff er en t s ca le s of th e se ve rit y of d ys ph ag ia . T he fu ll na m e, le ve ls , a nd d ire ct io ns o f t he s ev er ity o f e ac h sc al e ar e sh ow n. A dd iti on al ly , th er e is a n ex pl an at io n de ta ili ng w he th er o r n ot th e sc al e re qu ire s a n ob je ct iv e as se ss m en t, su ch a s t he V id eo flu or os co pi c S w al lo w in g St ud y (V FS S) o r t he F ib er op tic En do sc op ic E va lu at io n of S w al lo w in g (F EE S) a nd fo r w hi ch p op ul at io n th e sp ec ifi c s ca le is m os t s ui ta bl e. F ur th er m or e, th e m os t r ec en t p sy ch om et ric ch ar ac te ris tic s an d re co m m en da tio ns o f e ac h sc al e ar e al so m en tio ne d. 84 NEUROLOGY, NEUROPSYCHOLOGY, NEUROPHYSIOLOGY Zdrav Vestn | March – April 2022 | Volume 91 | https://doi.org/10.6016/ZdravVestn.3167 Sc al e (r ef er en ce ) Fu ll na m e Le ve ls Di re ct io n of se ve ri ty Re qu ir es a n ob je ct iv e as se ss m en t Po pu la tio n Re lia bi lit y an d va lid ity Re co m m en da tio ns FO IS (1 0) Fu nc tio na l O ra l In ta ke S ca le 7 Fr om 0 (n ot hi ng b y m ou th ) t o 7 (to ta l or al in ta ke w ith n o re st ric tio ns ) no In iti al ly fo r s tr ok e pa tie nt s, aft er w ar d st ud ie s i n tr au m at ic b ra in in ju ry (T BI ), he ad a nd n ec k ca nc er , vo ca l f ol d im m ob ili ty , va ga l s ch w an no m a re se ct io n, c er eb ra l p al sy , po st su rg ic al d ys ph ag ia , ne ur od eg en er at iv e di se as es , po st -e xt ub at io n dy sp ha gi a in c hi ld re n, n eu ro ge ni c dy sp ha gi a. St ro ke – h ig h in te rr at er re lia bi lit y (8 5% ), hi gh c rit er io n, an d co ns en su al v al id ity . Fo od re st ric tio n an d w ay o f f ee di ng . FO IS fo r in fa nt s ( 11 ) Fu nc tio na l O ra l In ta ke S ca le 5 Fr om 0 (n ot hi ng by m ou th ) t o 5 (e xp an si on o f o ra l di et re ac he d) no Th e ge ne ra l p op ul at io n of in fa nt s w ith d ys ph ag ia . H ig h in te r- ra te r r el ia bi lit y (9 5. 5% ) a nd si gn ifi ca nt ly co rr el at ed w ith a sp ira tio n se ve rit y in th e VF SS . Fo od re st ric tio n an d w ay o f f ee di ng . ID DS Fu nc tio na l Le ve l S ca le (2 8) Th e In te rn at io na l Dy sp ha gi a Di et St an da rd iz at io n In iti at iv e Fu nc tio na l D ie t Sc al e 9 0 (n o fo od a nd n o dr in ks ) t o 8 (n o re st ric tio ns ) no ge ne ra l In iti al c on se ns ua l v al id ity – 73 % a gr ee m en t, st ro ng in iti al cr ite rio n va lid ity w ith F O IS (R 0. 84 , p <. 00 1) , in iti al in te rr at er re lia bi lit y - h ig h in te rju dg e re lia bi lit y (K en da ll co nc or da nc e W =. 81 9) di et re st ric tio n M EO F- II (2 9) M in im al E at in g O bs er va tio n Fo rm – V er si on II 9 ye s- no ite m s Th re e di m en si on s (In ge st io n, de gl ut iti on a nd en er gy ) s co re d w ith 0 (p ro bl em ) o r 1 (w ith ou t a p ro bl em ). no el de rly Sa tis fy in g va lid ity a nd re lia bi lit y. To id en tif y m ea l- tim e pr ob le m s. M IS A (3 0) M cG ill In ge st iv e Sk ill s As se ss m en t 4 re sp on se s ca te go rie s, m ax . 1 29 sc or es (h ig he r sc or e, le ss pr ob le m s) 5 sc al es o f 5 6 ite m s no el de rly Pr el im in ar y hi gh in te rr at er ag re em en t ( 0. 90 ), an d ad eq ua te p re lim in ar y va lid ity . fu nc tio na l i ng es tiv e sk ill s SP SS (3 1) Sw al lo w in g Pe rfo rm an ce St at us S ca le 7 fro m 1 (n or m al ) t o 7 (s ev er e im pa irm en t) no pa tie nt s w ith n ec k an d ca nc er Re lia bl e ac ro ss th e ra te rs . Di et m od ifi ca tio n, w ay o f f oo d in ta ke . 85 ORIGINAL SCIENTIFIC ARTICLE Reliability and validity of the Slovenian Translation of the Functional Oral Intake Scale (FOIS-SI) This particular study was divided into two phases. Phase one was dedicated to the translation process, and phase two was focused on the study of reliability and validity of the Slovenian translation of FOIS (FOIS-SI) among clinicians. 2.1 Instrument description 2.1.1 Functional Oral Intake Scale FOIS is a reliable scale to assess the functional sever- ity of dysphagia. Observer-rated ordinal severity scale consists of seven levels, from nonoral feeding (Level 1) to oral feeding without any restrictions (Level 7). To quantify dysphagia severity, clinicians may obtain the level of dysphagia of a patient through medical charts, dietary diaries and/or verified patient reports (10). 2.1.2 Translation Permission for translation was obtained from the au- thor of the original FOIS scale (10). The translation was performed according to WHO guidelines of translation and adaptations of instruments (32). The phases were followed: (i) the initial translation from English to Slove- nian was performed by two speech and language pathol- ogists (SLPs); (ii) The synthesis of two translations was made to provide the initial version; (iii) Back-translation was performed by an independent translator, who did not know FOIS. Furthermore, discrepancies were dis- cussed between SLPs and independent translators until the complete Slovenian version; (iv) The final Slovenian translation was obtained, and the complete version was pre-tested; (v) Finally, the complete version was final- ized (see Table 2). Table 2: Original Functional Oral Intake Scale (FOIS) and Slovenian translation of FOIS (FOIS-SI). Functional Oral Intake Scale (FOIS) Tube dependent (Levels 1-3) 1 No oral intake 2 Tube dependent with minimal/inconsistence oral intake 3 Tube dependent with consistent oral intake of food or liquid Total oral intake (Levels 4-7) 4 Total oral intake of a single consistency 5 Total oral intake of multiple consistency requiring special preparation. 6 Total oral intake with no special preparation, but must avoid specific foods or liquid items 7 Total oral intake with no restrictions Lestvica funkcionalnega peroralnega vnosa (FOIS-SI) Odvisnost od hranilne cevke (raven 1-3) 1 Brez peroralnega vnosa. 2 Odvisnost od hranilne cevke z minimalnim/občasnim peroralnim vnosom. 3 Odvisnost od hranilne cevke z rednim peroralnim vnosom. Popoln peroralni vnos (raven 4-7) 4 Popoln peroralni vnos z eno konsistenco. 5 Popoln peroralni vnos z več konsistencami, ki zahtevajo poseben način priprave. 6 Popoln peroralni vnos brez posebne priprave, a z izogibanjem določenih izdelkov hrane/pijače. 7 Popoln peroralni vnos brez omejitev. 86 NEUROLOGY, NEUROPSYCHOLOGY, NEUROPHYSIOLOGY Zdrav Vestn | March – April 2022 | Volume 91 | https://doi.org/10.6016/ZdravVestn.3167 2.1.3 Subjects The clinical records of 30 patients with an acute isch- emic stroke in the carotid artery territory, who were hospitalized at the Division of Neurology of the UMC Ljubljana, Slovenia, were reviewed and sent to six SLPs. Included with the clinical records was a report of speech and language clinical bedside assessments of dysphagia (CBAD), sex, age, National Institutes of Health Stroke Scale (NIHSS) (33), and comorbidities of patients. The CBAD was performed within the first two weeks after the acute ischaemic stroke in the area of carotid artery, and covered the following details: (1) anatomy and func- tionality of oral structures, (2) feeding method, (3) de- scription of oral and pharyngeal phases of swallowing, possible symptoms of impaired safety and/or efficacy of swallowing, and (4) detailed IDDSI diet level of food and liquid (34). 2.1.4 Raters All raters were SLPs with more than 2 years of work- ing experience in treating patients with dysphagia (2 to 17 years of working experience, M=7.33 years). Their results were used to calculate interrater reliability. One skilled clinical SLP with 23 years of experience in treat- ing dysphagia patients was evaluating the same 30 clin- ical cases using both scales, IDDSI-FDS, and FOIS-SI. Those results were used to calculate convergent validity. 2.1.5 Interrater and intrarater reliability The interrater reliability of FOIS-SI was obtained as a result of comparing the scores of six SLPs from different facilities across the country. Regardless of their famil- iarity with the FOIS-SI scale, all raters received written instructions on how to evaluate the severity of dyspha- gia using the translated scale. They were asked to assign each speech and language pathology report a FOIS rat- ing between Level 1 and Level 7. Each rater was blinded to other raters’ evaluations. To evaluate intrarater reliability, two SLPs evaluated the same 30 clinical cases on two occasions within an interval of 10-14 days. The cases were shuffled to ensure as objective assessment as possible. 2.1.6 Convergent validity To evaluate convergent validity, we examined the association between FOIS-SI and IDDSI-Functional Diet Scale (IDDSI-FDS). The IDDSI-FDS was chosen according to CBAD recommendations on IDDSI diets (34), aiming to classify dysphagia severity based on sug- gested diet modifications. The IDDSI-FDS is a scale that can objectively capture oral dysphagia and texture restriction. Authors recom- mend its use for paediatric and adult populations, es- pecially where the IDDSI framework and its 8 levels of food and liquids consistency are used (28). One skilled clinical SLP evaluated 30 clinical cases separately, once with IDDSI-FDS and once with FOIS-SI. 2.1.7 Data gathering and statistical analysis For gathering data, we used Microsoft® Excel®, 2016. All statistical analyses were performed using SPSS Statis- tics, version 25, IBM® SPSS®. To calculate reliability the Intraclass Correlation Coefficient (ICC) was used. A two-way random-effect model based on single ratings and absolute agreement assessed the interrater reliability, and a two-way mixed effect model based on single rating and absolute agree- ment assessed the intrarater reliability for either rater. Interpretation was as follows: between 0.5 and 0.75, moderate; between 0.75 and 0.9, good; above 0.90, ex- cellent agreement (35). Mean estimations along with a 95% confidence interval (CI) were reported for the ICC. Convergent validity was calculated with the Spear- man’s rank correlation coefficient, assuming that a κ of 0.7 or more indicates a high positive correlation between two scales and more than 0.9 indicates a very high posi- tive correlation (36). 3 Results Of the 30 patients (age 72.23±1.73 years, ranging from 48 to 94 years), 7 were women and 23 were men (female to male ratio 1:3.29). The acute ischaemic stroke was located in the left carotid artery territory in 20 patients and in the right carotid artery territory in 10 patients. The most common pathologies found in the group of patients in the study were arterial hypertension (90%), hyperlipidaemia (70%), right-sided haemiparesis (56.67%), atrial fibrillation (40%), carotid artery stenosis (26.67%), and left-sided haemiparesis (20%). Regarding the NIHSS, the prevalent scores were severe (>13) in 15 patients (50%), moderate (6-13) in 11 patients (36.67%), and mild (1-5) in 4 patients (13.33%). The severity of dysphagia was assessed with FOIS-SI (see Table 3). The ICC was used to determine if there was an agree- ment between the SLPs’ judgements of clinical cases on FOIS-SI. The results showed that the ICC for interrater Table 3: The severity of dysphagia among 30 patients with acute stroke in the carotid artery territory as assessed by 6 raters using FOIS-SI. Additionally, 2nd ratings of two raters and one highly skilled SLP, who evaluated dysphagia using FOIS- SI and IDDSI-FDS. SLP 1 FOIS-SI 2 FOIS-SI 3 FOIS-SI 4 FOIS-SI 5 FOIS-SI 6 FOIS-SI Highly skilled SLP Case 1st rating 2nd rating 1st rating 2nd rating FOIS-SI IDDSI-FDS 1 1 1 1 1 1 1 1 1 1 0 2 5 5 5 5 6 6 5 5 5 5 3 5 5 5 5 5 5 6 6 5 6 4 5 5 5 5 4 4 5 5 5 5 5 1 2 1 1 1 1 1 1 1 0 6 5 5 5 5 5 5 5 5 5 6 7 2 2 2 2 3 3 2 2 2 0 8 5 5 5 5 4 4 4 4 5 5 9 5 5 5 5 4 4 5 5 5 5 10 5 5 5 5 5 5 6 5 5 6 11 5 5 5 5 4 4 5 6 5 5 12 5 5 5 5 4 4 5 5 5 5 13 5 5 5 5 5 5 5 5 5 6 14 6 6 6 6 6 6 6 6 6 7 15 2 1 2 2 2 2 1 1 2 0 16 4 4 4 4 4 4 4 4 4 1 17 1 1 1 1 1 1 1 1 1 0 18 5 5 5 5 5 5 5 5 5 6 19 1 1 1 1 1 1 1 1 1 0 20 6 6 6 6 6 6 5 5 6 7 21 4 4 4 4 4 4 4 4 4 1 22 5 5 6 5 6 6 6 6 5 7 23 5 5 5 5 5 5 5 5 5 6 24 7 7 7 7 7 7 7 7 7 8 25 5 5 4 5 5 5 5 5 5 3 26 1 1 1 1 1 1 1 1 1 0 27 2 2 2 2 1 1 2 2 2 0 28 4 4 4 4 4 4 4 4 4 1 29 4 4 4 4 4 4 4 4 4 1 30 6 6 6 5 6 6 6 6 5 7 Legend: SLP – speech and language pathologists; FOIS – Functional Oral Intake Scales; FOIS-SI – Slovenian translation of FOIS; IDDSI-FDS – Functional Diet Scale. 87 ORIGINAL SCIENTIFIC ARTICLE Reliability and validity of the Slovenian Translation of the Functional Oral Intake Scale (FOIS-SI) according to CBAD recommendations on IDDSI diets (34), aiming to classify dysphagia severity based on sug- gested diet modifications. The IDDSI-FDS is a scale that can objectively capture oral dysphagia and texture restriction. Authors recom- mend its use for paediatric and adult populations, es- pecially where the IDDSI framework and its 8 levels of food and liquids consistency are used (28). One skilled clinical SLP evaluated 30 clinical cases separately, once with IDDSI-FDS and once with FOIS-SI. 2.1.7 Data gathering and statistical analysis For gathering data, we used Microsoft® Excel®, 2016. All statistical analyses were performed using SPSS Statis- tics, version 25, IBM® SPSS®. To calculate reliability the Intraclass Correlation Coefficient (ICC) was used. A two-way random-effect model based on single ratings and absolute agreement assessed the interrater reliability, and a two-way mixed effect model based on single rating and absolute agree- ment assessed the intrarater reliability for either rater. Interpretation was as follows: between 0.5 and 0.75, moderate; between 0.75 and 0.9, good; above 0.90, ex- cellent agreement (35). Mean estimations along with a 95% confidence interval (CI) were reported for the ICC. Convergent validity was calculated with the Spear- man’s rank correlation coefficient, assuming that a κ of 0.7 or more indicates a high positive correlation between two scales and more than 0.9 indicates a very high posi- tive correlation (36). 3 Results Of the 30 patients (age 72.23±1.73 years, ranging from 48 to 94 years), 7 were women and 23 were men (female to male ratio 1:3.29). The acute ischaemic stroke was located in the left carotid artery territory in 20 patients and in the right carotid artery territory in 10 patients. The most common pathologies found in the group of patients in the study were arterial hypertension (90%), hyperlipidaemia (70%), right-sided haemiparesis (56.67%), atrial fibrillation (40%), carotid artery stenosis (26.67%), and left-sided haemiparesis (20%). Regarding the NIHSS, the prevalent scores were severe (>13) in 15 patients (50%), moderate (6-13) in 11 patients (36.67%), and mild (1-5) in 4 patients (13.33%). The severity of dysphagia was assessed with FOIS-SI (see Table 3). The ICC was used to determine if there was an agree- ment between the SLPs’ judgements of clinical cases on FOIS-SI. The results showed that the ICC for interrater Table 3: The severity of dysphagia among 30 patients with acute stroke in the carotid artery territory as assessed by 6 raters using FOIS-SI. Additionally, 2nd ratings of two raters and one highly skilled SLP, who evaluated dysphagia using FOIS- SI and IDDSI-FDS. SLP 1 FOIS-SI 2 FOIS-SI 3 FOIS-SI 4 FOIS-SI 5 FOIS-SI 6 FOIS-SI Highly skilled SLP Case 1st rating 2nd rating 1st rating 2nd rating FOIS-SI IDDSI-FDS 1 1 1 1 1 1 1 1 1 1 0 2 5 5 5 5 6 6 5 5 5 5 3 5 5 5 5 5 5 6 6 5 6 4 5 5 5 5 4 4 5 5 5 5 5 1 2 1 1 1 1 1 1 1 0 6 5 5 5 5 5 5 5 5 5 6 7 2 2 2 2 3 3 2 2 2 0 8 5 5 5 5 4 4 4 4 5 5 9 5 5 5 5 4 4 5 5 5 5 10 5 5 5 5 5 5 6 5 5 6 11 5 5 5 5 4 4 5 6 5 5 12 5 5 5 5 4 4 5 5 5 5 13 5 5 5 5 5 5 5 5 5 6 14 6 6 6 6 6 6 6 6 6 7 15 2 1 2 2 2 2 1 1 2 0 16 4 4 4 4 4 4 4 4 4 1 17 1 1 1 1 1 1 1 1 1 0 18 5 5 5 5 5 5 5 5 5 6 19 1 1 1 1 1 1 1 1 1 0 20 6 6 6 6 6 6 5 5 6 7 21 4 4 4 4 4 4 4 4 4 1 22 5 5 6 5 6 6 6 6 5 7 23 5 5 5 5 5 5 5 5 5 6 24 7 7 7 7 7 7 7 7 7 8 25 5 5 4 5 5 5 5 5 5 3 26 1 1 1 1 1 1 1 1 1 0 27 2 2 2 2 1 1 2 2 2 0 28 4 4 4 4 4 4 4 4 4 1 29 4 4 4 4 4 4 4 4 4 1 30 6 6 6 5 6 6 6 6 5 7 Legend: SLP – speech and language pathologists; FOIS – Functional Oral Intake Scales; FOIS-SI – Slovenian translation of FOIS; IDDSI-FDS – Functional Diet Scale. 88 NEUROLOGY, NEUROPSYCHOLOGY, NEUROPHYSIOLOGY Zdrav Vestn | March – April 2022 | Volume 91 | https://doi.org/10.6016/ZdravVestn.3167 reliability was excellent being 0.959 (0.934-0.978). Two SLPs (SLP 2 and SLP 6, see Table 3) evaluated 30 clinical cases on two occasions. The second evalua- tion was performed two weeks after the first one. The ICC for intrarater reliability was excellent being 0.979 (0.957-0.990) and 0.991 (0.980-0.995) for rater 2 and 6, respectively. One highly experienced SLP evaluated the same 30 cases with the FOIS and the IDDSI-FDS in parallel (see Table 3). Spearman’s rank correlation coefficient was used to evaluate convergent validity. There was a very high positive correlation between FOIS-SI and IDDSI-FDS, which was statistically significant, rs=0.927, p=.0001. 4 Discussion FOIS was initially developed for adult stroke patients (10). It has also been justified for the pediatric popula- tion (11), and patients with other diseases (15-23). The FOIS was translated into different languages (German, Italian, Chinese), where psychometric studies showed FOIS to be a valid instrument for the evaluation of dys- phagia (12-14). However, solely the German and the Chinese studies were comparable to ours since the Ital- ian study had a different research perspective. The purpose of the present paper was to translate and adapt the FOIS scale of functional severity of dysphagia in stroke patients and make this scale available to Slove- nian clinicians and researchers across the country in all clinical and care settings. The study was not intended to determine the reliability of clinical bedside examination itself. Enrolled SLPs evaluated 30 clinical records of stroke survivors. The patients had an ischemic stroke in the carotid artery territory. CBAD was performed by the time of patients’ acute phase after the stroke event. As far as reliability of the FOIS-SI is concerned, both in- tra- and interrater reliability were analyzed. The ICC for interrater and intrarater reliability were both excel- lent, the first being 0.959 and the second being 0.979 and 0.991. Intrarater reliability value was similar (or greater) to those reported in the German study, where Fleiss kappa (κ=0.83) showed high agreement; Chinese study, where Cohen kappa showed excellent agreement (κ=0.881); and original English study, where an average kappa value ranged from 0.86 to 0.91. High reliability in these studies could be because raters received prior FOIS training (12), the study taking place at just a single facili- ty (14), or the group of patients being more homogenous (10). There was no report about intrarater reliability in the aforementioned studies. Raters in our study were familiar with the FOIS-SI scale and received written in- structions beforehand, which can potentially contribute to the excellent interrater and intrarater reliability. How- ever, some discrepancies were found. The disagreements were mostly detected between FOIS Level 4 and 5 and between FOIS Level 2 and 3, where the insecurities were mostly about the different types of tubes and with the term single consistency (see Table 3). In our study, the validity of the FOIS-SI was evaluat- ed with the IDDSI-FDS theoretically related scale. The IDDSI-FDS scale was chosen since the IDDSI framework is slowly spreading both internationally and nationally. One highly skilled SLP evaluated the severity of dyspha- gia with both, FOIS-SI and IDDSI-FDS. Results have shown a very high positive correlation between these two scales. To our knowledge, a study of the correlation between these two scales has not been performed yet. The German and Chinese studies, on the other hand, tested the validity of the translated FOIS scales with the stroke scales NIHSS and MRS and showed signifi- cant correlation. Additionally, the German and Chinese studies correlated FOIS with the golden standards of di- agnosis of swallowing disorders (FEES and VFSS) and found a significant association between the severity of dysphagia as assessed by these two methods. However, the Chinese study did not show a significant correlation of FOIS with aspiration (14), which was the case as well in the original FOIS study (10). There is one major limitation in this study that could be addressed in future research. For convergent valida- tion, we used IDDSI-FDS, which was, up to this point, only initially validated. For this reason, further vali- dation studies using other scales or one of the golden standards for diagnosing swallowing problems, such as FEES or VFSS, should be used. However, the Chinese, German, and original study validated their FOIS scale not only with different dysphagia and stroke scales but also with the golden standards, which definitely con- firmed FOIS to be a valid scale to evaluate the severity of dysphagia in stroke survivors. Future studies should investigate, whether FOIS-SI can provide an accurate level of dysphagia severity in other groups of patients with dysphagia, and the respon- siveness of the scale to SLP treatment. 5 Conclusion This study was intended to determine the interrat- er reliability across clinicians from different clinical institutes across the entire country, evaluate intrarater 89 ORIGINAL SCIENTIFIC ARTICLE Reliability and validity of the Slovenian Translation of the Functional Oral Intake Scale (FOIS-SI) reliability, and determine the convergent validity of FOIS-SI. The initial psychometric characteristics study implies that FOIS-SI could be a useful tool for various clinical and scientific purposes for quantifying the severity of dysphagia across the country and different facilities. Since stroke patients often get transferred to different hospitals or clinics due to change in the amount of care they require as their treatment progresses, utilizing a standardized model between hospitals, clinics, and care settings can contribute to better dysphagia outcomes as well as to a higher quality of life in dysphagia patients. Conflict of interest None declared. Acknowledgments The authors would like to express their gratitude to the speech and language pathologists involved in this study. References 1. Hočevar Boltežar I. Fiziologija in patologija glasu ter izbrana poglavja iz patologije govora. 1st ed. Ljubljana: Pedagoška fakulteta; 2008. 2. Malone JC, Arya NR. StatPerls. Anatomy, Head and Neck, Swallowing. 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