Traumatology and Orthopedics of RussiaTraumatology and Orthopedics of RussiaТравматология и ортопедия России2311-29052542-0933Vreden National Medical Research Center of Traumatology and Orthopedics1750210.17816/2311-2905-17502CLINICAL STUDIESКЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯClinical studiesResearch ArticleSingle Assessment Numeric Evaluation score in shoulder pathologies: cross-cultural adaptation and validation into RussianКросс-культурная адаптация и валидация шкалы Single Assessment Numeric Evaluation для оценки состояния плечевого суставаhttps://orcid.org/0009-0005-7342-7974GazimievArthur M.ГазимиевАртур Магомедович
Russian Federation
a.gazimiev@yandex.ruhttps://orcid.org/0000-0003-2493-4601IlyinDmitriy O.ИльинДмитрий Олегович
Russian Federation

Dr. Sci. (Med.)

д-р мед. наук

dilyin@emcmos.ruhttps://orcid.org/0000-0002-9859-194XKonevaElizaveta S.КоневаЕлизавета Сергеевна
Russian Federation

Dr. Sci. (Med.)

д-р мед. наук

elizaveta.coneva@yandex.ruhttps://orcid.org/0000-0003-3235-5407LogvinovAleksey N.ЛогвиновАлексей Николаевич
Russian Federation

Cand. Sci. (Med.)

канд. мед. наук

alogvinov@emcmos.ruhttps://orcid.org/0000-0002-1412-9986PilipsonZhanna Y.ПилипсонЖанна Юрьевна
Russian Federation
zhpilipson@emcmos.ruhttps://orcid.org/0000-0002-2973-8303FrolovAlexander V.ФроловАлександр Владимирович
Russian Federation

Cand. Sci. (Med.)

канд. мед. наук

afrolov@emcmos.ruhttps://orcid.org/0000-0001-5468-5074LyadovKonstantin V.ЛядовКонстантин Викторович
Russian Federation

Dr. Sci. (Med.), Professor

академик РАН, профессор, д-р мед. наук

klyadov@mail.ruhttps://orcid.org/0000-0001-9964-5199AchkasovEvgenii E.АчкасовЕвгений Евгеньевич
Russian Federation

Dr. Sci. (Med.), Professor

д-р мед. наук, профессор

achkasov_e_e@staff.sechenov.ruhttps://orcid.org/0000-0002-8769-9963KorolevAndrey V.КоролёвАндрей Вадимович
Russian Federation

Dr. Sci. (Med.), Professor

д-р мед. наук, профессор

akorolev@emcmos.ruI.M. Sechenov First Moscow State Medical University (Sechenov University)ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет)European Clinic of Sports Traumatology and Orthopedics (ECSTO)Европейская клиника спортивной травматологии и ортопедии (ECSTO)Peoples’ Friendship University of Russia named after Patrice LumumbaФГАОУ ВО «Российский университет дружбы народов им. Патриса Лумумбы»I.M. Sechenov First Moscow State Medical University (Sechenov University)ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет)European Clinic of Sports Traumatology and Orthopedics (ECSTO)Европейская клиника спортивной травматологии и ортопедии (ECSTO)Peoples’ Friendship University of Russia named after Patrice LumumbaФГАОУ ВО «Российский университет дружбы народов им. Патриса Лумумбы»14062024040720243021091191803202414052024Copyright ©; 2024, Eco-VectorCopyright ©; 2024, Эко-ВекторCopyright ©; 2024,2024Eco-VectorЭко-Векторhttps://creativecommons.org/licenses/by-nc-nd/4.0https://journal.rniito.org/jour/article/view/17502

Background. Single Assessment Numeric Evaluation (SANE) Score is a single-answer scale widely used within the global medical community. However, to date, it has not been adapted and validated into Russian, particularly as a tool to assess orthopedic shoulder conditions.

The aim of the study is to conduct a cross-cultural adaptation and validation of the Russian version of the SANE score as an assessment tool of orthopedic shoulder conditions.

Methods. The study included a total of 160 patients with various shoulder pathologies, of which 101 (63%) males and 59 (37%) females. The median age was 45 (37-52) years. At the first stage of the study, we performed cross-cultural adaptation of the SANE score into Russian. The second stage was the validation of the obtained score. Its reliability, validity and responsiveness were evaluated. Reliability was assessed by “test-retest” method. It allowed to measure an intra-class correlation coefficient (ICC) between the SANE score results obtained at the time of the first appointment and again in 14 days. The validity assessment was based on the comparison of the SANE and ASES (have already been adapted into Russian) score results. Responsiveness was assessed using statistical analysis for two dependent samples and calculation of the Guyatt’s Responsivity Index (GRI). Floor and ceiling effects were evaluated as the percentage of patients who reported either minimum or maximum scores.

Results. The psychometric properties assessment has revealed good indicators of reliability (ICC = 0.77), validity (a strong direct correlation between SANE and ASES scores = 0.707; a moderate strength inverse correlation with ASES “Intensity of pain” subsection = 0.542) and responsiveness (GRI = 1.861). Floor and ceiling effects accounted for <1% and 3%, respectively, (all below 15%).

Conclusions. Adapted to assess the shoulder conditions, the Russian version of the SANE score has good psychometric properties. Its advantage is the combination of completion speed and ease of use with a high-quality integrated subjective assessment of the patients’ set of complaints.

Актуальность. Single Assessment Numeric Evaluation (SANE) Score — широко используемая в мировом медицинском сообществе цифровая шкала оценки по одному ответу. Однако до настоящего времени она не проходила процесс адаптации и валидации для использования на русском языке, в частности применительно к оценке состояния плечевого сустава.

Целью работы является кросс-культурная адаптация и валидация шкалы SANE для оценки состояния плечевого сустава у пациентов ортопедического профиля.

Материал и методы. В исследование были включены 160 пациентов с разными заболеваниями области плеча, в том числе 101 (63%) мужчина и 59 (37%) женщин. Медиана возраста составила 45 лет (37–52). На первом этапе исследования была проведена кросс-культурная адаптация русскоязычной версии шкалы SANE. Вторым этапом являлась валидация полученной шкалы. Были оценены ее надежность, валидность и чувствительность. Надежность оценивалась методом «тест-ретест», с помощью которого у отобранной группы был оценен коэффициент внутриклассовой корреляции (ICC — intra-class correlation coefficient) между результатами SANE при первичном обращении и повторно через 14 дней. Валидность оценивалась на основании сравнительного анализа результатов шкалы SANE и опросника ASES, уже адаптированного в России. Оценка чувствительности проводилась с помощью статистического анализа для двух зависимых выборок и вычисления индекса чувствительности опросника Guyatt’s Responsiveness Index (GRI). Эффекты максимальных и минимальных значений были оценены как процент пациентов c минимальными или максимальными значениями ответов по шкале.

Результаты. При оценке психометрических свойств шкалы SANE были выявлены высокие показатели надежности (ICC = 0,77), валидности (сильная прямая корреляция между шкалами SANE и ASES — 0,707; средней силы обратная корреляция с подразделом «интенсивность болевого синдрома» шкалы ASES — 0,542) и чувствительности (GRI = 1,861). Эффекты «пола» и «потолка» составили <1% и 3% соответственно (все показатели ниже 15%).

Заключение. Адаптированная с целью оценки состояния плечевого сустава русская версия шкалы SANE обладает хорошими психометрическими показателями. Ее преимуществом является сочетание быстроты заполнения и удобства в использовании с качественной интегрированной субъективной оценкой пациентом комплекса имеющихся у него жалоб.

cross-cultural adaptationshoulder pathologyassessment scaleSANEASESDASHpsychometric propertiesкросс-культурная адаптацияпатология плечевого суставашкала оценкиSANEASESDASHпсихометрические свойства опросникаUrwin M., Symmons D., Allison T., Brammah T., Busby H., Roxby M. et al. Estimating the burden of musculoskeletal disorders in the community: the comparative prevalence of symptoms at different anatomical sites, and the relation to social deprivation. Ann Rheum Dis.1998;57(11):649-655. doi: 10.1136/ard.57.11.649.Longo U.G., Berton A., Papapietro N., Maffulli N., Denaro V. Epidemiology, genetics and biological factors of rotator cuff tears. Med Sport Sci. 2012;57:1-9. doi: 10.1159/000328868.Ferlito R., Testa G., McCracken K.L., Moscato S., Zerbito G.M., Panvini F.M.C. et al. Effectiveness of Therapeutical Interventions on the Scapulothoracic Complex in the Management of Patients with Subacromial Impingement and Frozen Shoulder: A Systematic Review. J Funct Morphol Kinesiol. 2023;8(2):38. doi: 10.3390/JFMK8020038.Luime J.J., Koes B.W., Hendriksen I.J., Burdorf A., Verhagen A.P., Miedema H.S. et al. Prevalence and incidence of shoulder pain in the general population: a systematic review. Scand J Rheumatol. 2004;33(2): 73-81. doi: 10.1080/03009740310004667.Lucas J., van Doorn P., Hegedus E., Lewis J., van der Windt D. A systematic review of the global prevalence and incidence of shoulder pain. BMC Musculoskelet Disord. 2022;23(1):1073. doi: 10.1186/s12891-022-05973-8.Cotter E.J., Hannon C.P., Christian D., Frank R.M., Bach B.R.Jr. Comprehensive Examination of the Athlete's Shoulder. Sports Health. 2018;10(4):366-375.doi: 10.1177/1941738118757197.Lafrance S., Charron M., Roy J.S., Dyer J.O., Frémont P., Dionne C.E. et al. Diagnosing, Managing, and Supporting Return to Work of Adults With Rotator Cuff Disorders: A Clinical Practice Guideline. Orthop Sports Phys Ther. 2022;52(10):647-664. doi: 10.2519/jospt.2022.11306.Ягджян Г.В., Абраамян Д.О., Геворгян А.М. Адаптация русской версии опросника DASH. Анналы пластической, реконструктивной и эстетической хирургии. 2004;(4):166-167. Yagyan G.V., Abrahamyan D.O., Georgyan A.M. Adaptation of the Russian version of the DASH questionnaire. Annals of Plastic, Reconstructive and Aesthetic Surgery. 2004;(4):166-167. (In Russian).McClure P., Michener L. Measures of adult shoulder function: The American Shoulder and Elbow Surgeons Standardized Shoulder Form Patient Self-Report Section (ASES), Disabilities of the Arm, Shoulder, and Hand (DASH), Shoulder Disability Questionnaire, Shoulder Pain and Disability Index (SPADI), and Simple Shoulder Test. Arthritis Rheum. 2003;49(5):50-58. doi: 10.1002/art.11404.Ильин Д.О., Макарьева О.В., Макарьев М.Н., Логвинов А.Н., Магнитская Н.Е., Рязанцев М.С. и др. Кросс-культурная адаптация и валидация стандартизированной шкалы American Shoulder and Elbow Surgeons (ASES). Травматология и ортопедия России. 2020;26(1):116-126. doi: 10.21823/2311-2905-2020-26-1-116-126. Ilʼin D.O., Makarieva O.V., Makariev M.N., Logvinov A.N., Magnitskaya N.E., Ryazantsev M.S. et al. American Shoulder and Elbow Surgeons Standardized Assessment Form: Russian Cross-Cultural Adaptation and Validation. Traumatology and Orthopedics of Russia. 2020;26(1):116-126. (In Russian). doi: 10.21823/2311-2905-2020-26-1-116-126.Richards R.R., An K.N., Bigliani L.U., Friedman R.J., Gartsman G.M., Gristina A.G. et al. A standardized method for the assessment of shoulder function. J Shoulder Elbow Surg. 1994;3(6):347-352. doi: 10.1016/S1058-2746(09)80019-0.Çelik D., Atalar A.C., Demirhan M., Dirican A. Translation, cultural adaptation, validity and reliability of the Turkish ASES questionnaire. Knee Surg Sports Traumatol Arthrosc. 2013;21(9):2184-2189. doi: 10.1007/s00167-012-2183-3.Goldhahn J., Angst F., Drerup S., Pap G., Simmen B.R., Mannion A.F. Lessons learned during the cross-cultural adaptation of the American Shoulder and Elbow Surgeons shoulder form into German. J Shoulder Elbow Surg. 2008;17(2):248-254. doi: 10.1016/j.jse.2007.06.027.Michener L.A., McClure P.W., Sennett B.J. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elbow Surg. 2002;11(6):587-594. doi: 10.1067/mse.2002.127096.Moser A.D., Knaut L.A., Zotz T.G., Scharan K.O. Validity and reliability of the Portuguese version of the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form. Rev Bras Reumatol. 2012;52(3): 348-356. doi: 10.1590/S0482-50042012000300005.Padua R., Padua L., Ceccarelli E., Bondi R., Alviti F., Castagna A. Italian version of ASES questionnaire for shoulder assessment: cross-cultural adaptation and validation. Musculoskelet Surg. 2010;94 Suppl 1:85-90. doi: 10.1007/s12306-010-0064-9.Piitulainen K., Paloneva J., Ylinen J., Kautiainen H., Häkkinen A. Reliability and validity of the Finnish version of the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient selfreport section. BMC Musculoskelet Disord. 2014;15:272. doi: 10.1186/1471-2474-15-272.Vrotsou K., Cuéllar R., Silió F., Rodriguez M.Á., Garay D., Busto G. et al. Patient self-report section of the ASES questionnaire: a Spanish validation study using classical test theory and the Rasch model. Health Qual Life Outcomes. 2016;14(1):147. doi: 10.1186/s12955-016-0552-1.Yahia A., Guermazi M., Khmekhem M., Ghroubi S., Ayedi K., Elleuch M.H. Translation into Arabic and validation of the ASES index in assessment of shoulder disabilities. Ann Phys Rehabil Med. 2011;54(2):59-72. (In English, French). doi: 10.1016/j.rehab.2010.12.002.Struyf F., Nijs J., Mollekens S., Jeurissen I., Truijen S., Mottram S. et al. Scapular-focused treatment in patients with shoulder impingement syndrome: a randomized clinical trial. Clinical Rheumatology. 2013;32(1):73-85. doi:10.1007/S10067-012-2093-2.Cheng C., Chen B., Xu H., Zhang Z., Xu W. Efficacy of concomitant acromioplasty in the treatment of rotator cuff tears: A systematic review and meta-analysis. PLoS One. 2018;13(11):e0207306. doi: 10.1371/journal.pone.0207306.Williams G.N., Gangel T.J., Arciero R.A., Uhorchak J.M., Taylor, D.C. Comparison of the Single Assessment Numeric Evaluation Method and Two Shoulder Rating Scales. Outcomes measures after shoulder surgery. Am J Sports Med. 1999;27(2):214-221. doi: 10.1177/03635465990270021701.Garcia A.N., Cook C., Lutz A., Thigpen C.A. Concurrent validity of the single assessment numerical evaluation and patient-reported functional measures in patients with musculoskeletal disorders: An observational study. Musculoskelet Sci Pract. 2019;44:102057. doi: 10.1016/j.msksp.2019.102057.Thigpen C.A., Shanley E., Momaya A.M., Kissenberth M.J., Tolan S.J., Tokish J. M. et al. Validity and Responsiveness of the Single Alpha-numeric Evaluation for Shoulder Patients. Am J Sports Med. 2018; 46(14):3480-3485. doi:10.1177/0363546518807924.Retzky J.S., Baker M., Hannan C.V., Srikumaran U. Single Assessment Numeric Evaluation scores correlate positively with American Shoulder and Elbow Surgeons scores postoperatively in patients undergoing rotator cuff repair. J Shoulder Elbow Surg. 2020;29(1):146-149. doi: 10.1016/j.jse.2019.05.039.Gutiérrez-Zúñiga D., Mejía-Grueso A., Olmos-Muskus N., Valbuena-Bernal F., Largacha-Ponce de León M. Translation, validation and cultural adaptation of the SANE (Single Assessment Numeric Evaluation) in patients with shoulder pathology. Acta Ortop Mex. 2021;35(4):354-358. (In Spanish).Provencher M.T., Frank R.M., Macian D., Dewing C.B., Ghodadra N.S., Carney J. et al. An Analysis of Shoulder Outcomes Scores in 275 Consecutive Patients: Disease-Specific Correlation Across Multiple Shoulder Conditions. Mil Med. 2012;177(8):975-982. doi: 10.7205/MILMED-D-11-00234.Cunningham G., Lädermann A., Denard P.J., Kherad O., Burkhart S.S. Correlation Between American Shoulder and Elbow Surgeons and Single Assessment Numerical Evaluation Score After Rotator Cuff or SLAP Repair. Arthroscopy. 2015;31(9):1688-1692. doi: 10.1016/j.arthro.2015.03.010.Zhang J., Barron J., Arvesen J., Israel H., Kim C., Kaar S. Effect of Patient Resilience and the Single Assessment Numeric Evaluation (SANE) Score on Return to Sport Following Anterior Cruciate Ligament Reconstruction Surgery. Arch Bone Jt Surg. 2021;9(5):512-518. doi: 10.22038/abjs.2021.48823.2562.O’Connor C.M., Ring D. Correlation of Single Assessment Numeric Evaluation (SANE) with other Patient Reported Outcome Measures (PROMs). Arch Bone Jt Surg. 2019;7(4):303-306. doi: 10.22038/abjs.2018.33884.1888.Dumont G.D., Glenn R.L., Battle N.C., Thier Z.T. Correlation of the Single-Assessment Numeric Evaluation (SANE) Score With Hip-Specific Patient-Reported Outcome Measures. Arthrosc Sports Med Rehabil. 2021;3(2):435-440. doi: 10.1016/j.asmr.2020.10.008.Torchia M.T., Austin D.C., Werth P.M., Lucas A.P., Moschetti W.E., Jevsevar D.S. A SANE Approach to Outcome Collection? Comparing the Performance of Single- Versus Multiple-Question Patient-Reported Outcome Measures After Total Hip Arthroplasty. J Arthroplasty. 2020;35(6):207-213. doi: 10.1016/j.arth.2020.01.015.Lau B.C., Scribani M., Lassiter T., Wittstein J. Correlation of Single Assessment Numerical Evaluation Score for Sport and Activities of Daily Living to Modified Harris Hip Score and Hip Outcome Score in Patients Undergoing Arthroscopic Hip Surgery. Am J Sports Med. 2019;47(11):2646-2650. doi: 10.1177/0363546519863411.Theeuwen D.M.J., van der Steen M.C., Bonneux I.F.M., Giesberts A.M.E., Koot H.W.J., Reijman M. Translation and evaluation of psychometric properties of the Dutch version of the Single Assessment and Numeric Evaluation Method (SANEM) in shoulder patients. J Orthop Surg Res. 2019;14(1):303. doi: 10.1186/s13018-019-1335-2.Gilbart M.K., Gerber C. Comparison of the subjective shoulder value and the Constant score. J Shoulder Elbow Surg. 2007;16(6):717-721. doi: 10.1016/j.jse.2007.02.123.Nazari G., MacDermid J.C., Bobos P., Furtado R. Psychometric properties of the Single Assessment Numeric Evaluation (SANE) in patients with shoulder conditions. A systematic review. Physiotherapy. 2020;109:33-42. doi:10.1016/j.physio.2020.02.008.Wickman J.R., Lau B.C., Scribani M.B., Wittstein J.R. Single Assessment Numeric Evaluation (SANE) correlates with American Shoulder and Elbow Surgeons score and Western Ontario Rotator Cuff index in patients undergoing arthroscopic rotator cuff repair. J Shoulder Elbow Surg. 2020;29(2):363-369. doi:10.1016/J.JSE.2019.07.013.Anderson A.B., Tenan M.S., Dickens J.F. Latent Factor Analysis of the PROMIS and Single Assessment Numeric Evaluation in Patients Undergoing Shoulder Surgery. Mil Med. 2022;187(7-8):882-888. doi: 10.1093/milmed/usab327.Cohn M.R., Kunze K.N., Polce E.M., Nemsick M., Garrigues G.E., Forsythe B. et al. Establishing clinically significant outcome thresholds for the Single Assessment Numeric Evaluation 2 years following total shoulder arthroplasty. J Shoulder Elbow Surg. 2021;30(4):137-146. doi: 10.1016/j.jse.2020.07.011.Beaton D.E., Bombardier C., Guillemin F., Ferraz M.B. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000;25(24):3186-3191. doi: 10.1097/00007632-200012150-00014.Бараненков А.А., Голозубов О.М., Голубев В.Г., Голубев Г.Ш., Жданов В.Г. Региональная адаптация шкалы оценки исходов повреждений заболеваний коленного сустава KOOS. Травматология и ортопедия России. 2007;(1):26-32. Baranenkov A.A., Golozubov O.M., Golubev V.G., Golubev G.Sh., Zhdanov V.G. The regional adaptation of KOOS rating scale of the outcomes of knee injuries and diseases. Traumatology and Orthopedics of Russia. 2007;(1):26-32. (In Russian).Lim C.R., Harris K., Dawson J., Beard D.J., Fitzpatrick R., Price A.J. Floor and ceiling effects in the OHS: an analysis of the NHS PROMs data set. BMJ Open. 2015;5(7):e007765. doi: 10.1136/bmjopen-2015-007765.Cronbach L.J. Coefficient alpha and the internal structure of tests. Psychometrika. 1951;16:297-334. doi: 10.1007/BF02310555.Guyatt G., Walter S., Norman G. Measuring change over time: assessing the usefulness of evaluative instruments. J Chronic Dis. 1987;40(2):171-178. doi: 10.1016/0021-9681(87)90069-5.Robins R.J., Zhang Y., Anderson M.B., Presson A.P., Burks R.T., Greis P.E. Convergent Validity of the Patient Reported Outcomes Measurement Information System's (PROMIS) Physical Function Computerized Adaptive Test (PF-CAT) for the Knee and Shoulder Injury Sports Medicine Patient Population. Orthop J Sports Med. 2015;3(2 Suppl):2325967115S00147. doi: 10.1177/2325967115S00147.Baumgarten K.M. Can the Single Assessment Numeric Evaluation be used as a stand-alone subjective outcome instrument in patients undergoing rotator cuff repair? J Shoulder Elbow Surg. 2022;31(12):2542-2553. doi: 10.1016/j.jse.2022.05.017.Sciascia A.D., Morris B.J., Jacobs C.A., Edwards T.B. Responsiveness and Internal Validity of Common Patient-Reported Outcome Measures Following Total Shoulder Arthroplasty. Orthopedics. 2017;40(3):513-519. doi: 10.3928/01477447-20170327-02.Portney L.G., Watkins M.P. Foundations of Clinical Research: Applications to Practice. 3rd ed. Pearson: Prentice Hall; 2008. 892 p.Terwee C.B., Mokkink L.B., Knol D.L., Ostelo R.W., Bouter L.M., de Vet H.C. Rating the methodological quality in systematic reviews of studies on measurement properties: a scoring system for the COSMIN checklist. Qual Life Res. 2012;21(4):651-657. doi: 10.1007/s11136-011-9960-1.