Navigating the New EU Medical Devices Regulation: Retrospective Post-Market Follow-Up of Hyaluronic Acid Injections for Knee Osteoarthritis.

Purpose: The entry into force of the new Medical Device Regulation (EU) 2017/745 highlights the need for post-market clinical follow-up to ensure the safety and efficacy throughout the life cycle of medical devices. This study evaluates the efficacy and safety of a single intra-articular hyaluronic acid injection in knee osteoarthritis in real-world conditions, over a six-month period, aligning with the summary of safety and clinical performance (SSCP) required by the new regulation. Patients and Methods: Patients over 18 years of age with knee osteoarthritis, treated with a single injection of HA (Adant® One, Meiji Pharma Spain, Spain) at a 3rd level hospital. Patients were treated and followed between January 1, 2020 and June 30, 2022. Demographic, clinical, and treatment-related data were collected, and efficacy regarding pain relief and/or function improvement was assessed using a Likert-type scale. Data were pseudo-anonymized and the comparison was performed using Fisher' or Mann Whitney' test. The study was approved by the Ethics Review Board of the Hospital Puerta de Hierro (Madrid, Spain). Results: We followed 20 patients with knee osteoarthritis, with a mean age of 61 years, 80% women, and with a high burden of comorbidities (90%). A total of 60% of patients presented Kellgren-Lawrence grade III-IV. Four patients (20%) returned before 6 months due to lack of efficacy. Of the other patients, 65% showed a clinical response that lasted more than 12 months in 38.5% of cases. Time until medical appointment and taking concomitant medication for knee osteoarthritis were associated with better clinical response (p < 0.05). Conclusion: The administration of a Adant® One single intra-articular hyaluronic acid injection in knee osteoarthritis is effective, safe, and maintains the improvement over a six-month period. Our findings also emphasize the need of using standardized tools for accurate efficacy assessment and optimal patient care.

Revisión sistemática de los cuestionarios autocumplimentados adaptados al español para la valoración funcional de pacientes con patología de cadera / Systematic review of cross-cultural adaptations of hip-specific patient-reported outcome measures in Spanish

Objetivo: Realizar una revisión sistemática de la calidad de los procedimientos de adaptación y de las propiedades psicométricas de los cuestionarios autoadministrados de valoración funcional de cadera adaptados a la población española. Material y método: Se realizó una búsqueda en las bases de datos MEDLINE, EMBASE, CINAHL y Web of Science (desde su inicio hasta junio de 2016) para localizar todas las escalas adaptadas al español y analizar las diferentes fases del proceso de adaptación y sus propiedades psicométricas. Resultados: Se identificaron 8 escalas que se agruparon en 3 apartados, según el tipo de patologías en las que se pueden utilizar, a) todo el miembro inferior: Lower Limb Functional Index (LLFI), Lower Extremity Functional Scale (LEFS) y Arthrose des Membres Inférieurs et Qualité de vie (AMICAL); b) rodilla y/o cadera: Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index, Osteoarthritis Knee and Hip Quality of Life (OAKHQOL) y Hip and Knee Questionnaire (HKQ), y c) exclusivas de cadera: Hip Outcome Score (HOS) e International Hip Outcome Tool-33 (iHOT-33). El procedimiento de adaptación transcultural fue aceptable en todos los casos, aunque algo menos riguroso para las escalas HKQ y LLFI. Ningún estudio evaluó todas las propiedades psicométricas. Conclusión: Disponemos actualmente de 8 cuestionarios de valoración funcional de cadera adaptados al español con aceptables características psicométricas. Podemos medir la repercusión percibida por el paciente de su patología de cadera seleccionando, entre las diferentes opciones, aquellas alternativas que mejor se adapten a nuestros objetivos, ya sean clínicos o de investigación

Objective: The aim of this study was to conduct a systematic review of the quality of the transcultural adaptation procedure and the clinimetric properties of the self-administered hip-disability functional assessment questionnaires adapted for the Spanish population. Material and method: We searched the MEDLINE, EMBASE, CINAHL and Web of Science databases (from inception until June 2016) to locate all the scales adapted to Spanish and to analyze the different phases of the adaptation process and its psychometric properties. Results: Eight scales were identified, and were grouped into three sections, according to the type of diseases in which they can be used: a) lower limb: Lower Limb Functional Index (LLFI), Lower Extremity Functional Scale (LEFS) and Arthrosis of Membres Inférieurs et Qualité de vie (AMICAL); b) knee and/or hip: Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index, Osteoarthritis Knee and Hip Quality of Life (OAKHQOL) and Hip and Knee Questionnaire (HKQ); and c) specific for hip: Hip Outcome Score (HOS) and International Hip Outcome Tool-33 (iHOT-33). The transcultural adaptation procedure was satisfactory in all cases, albeit somewhat less rigorous for the HKQ and LLFI than for the remaining questionnaires. No study evaluated all the psychometric properties. Conclusion: We currently have 8 hip-disability functional assessment questionnaires adapted to Spanish with satisfactory psychometric properties. We can measure the patient's perceived impact of his or her hip disease by selecting, among the different options, those alternatives that best fit our clinical or research objectives

Systematic review of cross-cultural adaptations of hip-specific patient-reported outcome measures in Spanish. / Revisión sistemática de los cuestionarios autocumplimentados adaptados al español para la valoración funcional de pacientes con patología de cadera.

OBJECTIVE: The aim of this study was to conduct a systematic review of the quality of the transcultural adaptation procedure and the clinimetric properties of the self-administered hip-disability functional assessment questionnaires adapted for the Spanish population. MATERIAL AND METHOD: We searched the MEDLINE, EMBASE, CINAHL and Web of Science databases (from inception until June 2016) to locate all the scales adapted to Spanish and to analyze the different phases of the adaptation process and its psychometric properties. RESULTS: Eight scales were identified, and were grouped into three sections, according to the type of diseases in which they can be used: a) lower limb: Lower Limb Functional Index (LLFI), Lower Extremity Functional Scale (LEFS) and Arthrosis of Membres Inférieurs et Qualité de vie (AMICAL); b) knee and/or hip: Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index, Osteoarthritis Knee and Hip Quality of Life (OAKHQOL) and Hip and Knee Questionnaire (HKQ); and c) specific for hip: Hip Outcome Score (HOS) and International Hip Outcome Tool-33 (iHOT-33). The transcultural adaptation procedure was satisfactory in all cases, albeit somewhat less rigorous for the HKQ and LLFI than for the remaining questionnaires. No study evaluated all the psychometric properties. CONCLUSION: We currently have 8 hip-disability functional assessment questionnaires adapted to Spanish with satisfactory psychometric properties. We can measure the patient's perceived impact of his or her hip disease by selecting, among the different options, those alternatives that best fit our clinical or research objectives.

Assessment of cross-cultural adaptations of patient-reported shoulder outcome measures in Spanish: a systematic review.

BACKGROUND: The present study aimed to conduct a systematic review of self-administered shoulder-disability functional assessment questionnaires adapted to Spanish, analyzing the quality of the transcultural adaptation and the clinimetric properties of the new version. METHODS: A search of the main biomedical databases was conducted to locate Spanish shoulder function assessment scales. The authors reviewed the papers and considered whether the process of adaptation of the questionnaire had followed international recommendations, and whether its psychometric properties had been appropriately assessed. RESULTS: The search identified nine shoulder function assessment scales adapted to Spanish: Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH), Upper Limb Functional Index (ULFI), Simple Shoulder Test (SST), Shoulder Pain and Disability Index (SPADI), Oxford Shoulder Score (OSS), Shoulder Disability Questionnaire (SDQ), Western Ontario Rotator Cuff index (WORC), Western Ontario Shoulder Instability index (WOSI) and Wheelchair Users Shoulder Pain Index (WUSPI). The DASH was adapted on three occasions and the SPADI on two. The transcultural adaptation procedure was generally satisfactory, albeit somewhat less rigorous for the SDQ and WUSPI. Reliability was analyzed in all cases. Validity was not measured for one of the adaptations of the DASH, nor was it measured for the SDQ. CONCLUSIONS: The transcultural adaptation was satisfactory and the psychometric properties analyzed were similar to both the original version and other versions adapted to other languages.