Viviana Corallo1,2, Monica Torre3,4, Giovanna Ferrara5, Federica Guerra5, Gabriella Nicosia2, Ersilia Romanelli6, Angela Lopopolo6, Maria P Onesta2, Pietro Fiore6, Roberta Falcone7, Jacopo Bonavita5, Marco Molinari3,4, Giorgio Scivoletto8,4. 1. Physical Medicine and Rehabilitation Residency Department, University of Catania, Catania, Italy. 2. Spinal Cord Unit, Cannizzaro Hospital, Catania, Italy. 3. Spinal Cord Unit, IRCCS S. Lucia Foundation, Rome, Italy. 4. Spinal Research (SpiRe) Laboratory, IRCCS S. Lucia Foundation, Rome, Italy. 5. Spinal Cord Unit, Montecatone Rehabilitation Institute, Imola, Bologna, Italy. 6. Spinal Cord Unit, Bari University Policlinic, Bari, Italy. 7. Statistics Faculty, Bologna University, Bologna, Italy. 8. Spinal Cord Unit, IRCCS S. Lucia Foundation, Rome, Italy - g.scivoletto@hsantalucia.it.
Abstract
BACKGROUND: The Spinal Cord Independence Measure (SCIM III) is a scale of independence in the activities of daily life, specifically designed for spinal cord injury subjects. AIM: The aim of this study was to calculate the minimal clinically important difference (MCID) of the SCIM III according to distribution and anchor based approach. DESIGN: Prospective study. SETTING: Four Spinal Cord Units in Italy. POPULATION: Patients with acute/subacute spinal cord injury/lesion. METHODS: The scores of the total SCIM and of the four subscale was recorded at admission and discharge. Clinical significance was calculated according to anchor based methodology using a global rating of change questionnaire. The accuracy of MCID values in predicting a judgment of small improvement by the patients has been assessed by means of the area under the receiving operating curves (aROC). RESULTS: Total SCIM MCID values varied from 12 for patients with complete tetraplegia to 45.3 for those with incomplete thoracic lesions. The MCID of self-care varied from 3.3 to 8.5 and from 10 to 18 for respiration and sphincter management, depending on the level and severity of the lesion. With regard to mobility (room and toilet), the MCID varied from 1 to 3 and from 2.5 to 7.26 for mobility (indoors and outdoors). The aROC was between good and excellent for all these values. CONCLUSIONS: The results provide benchmarks for clinicians and researchers to interpret whether patients' change score on the SCIM III can be interpreted as true or clinically meaningful and to make clinical judgments about the patients' progress. CLINICAL REHABILITATION IMPACT: Our data could be useful for both clinicians and researchers. At the beginning of rehabilitation clinicians may have an idea of the minimal improvement of the patient (based on his neurological status) that could have an impact on patient's life. At the end of rehabilitation process, it is possible to control if the patient achieved an improvement that is true and significant. Researchers could also use these criteria to evaluate the clinical significance of an intervention by calculating the number of subjects in the treatment and control groups (or in two different treatment groups) who achieved a change calculated as the natural recovery plus the MCID.
BACKGROUND: The Spinal Cord Independence Measure (SCIM III) is a scale of independence in the activities of daily life, specifically designed for spinal cord injury subjects. AIM: The aim of this study was to calculate the minimal clinically important difference (MCID) of the SCIM III according to distribution and anchor based approach. DESIGN: Prospective study. SETTING: Four Spinal Cord Units in Italy. POPULATION: Patients with acute/subacute spinal cord injury/lesion. METHODS: The scores of the total SCIM and of the four subscale was recorded at admission and discharge. Clinical significance was calculated according to anchor based methodology using a global rating of change questionnaire. The accuracy of MCID values in predicting a judgment of small improvement by the patients has been assessed by means of the area under the receiving operating curves (aROC). RESULTS: Total SCIM MCID values varied from 12 for patients with complete tetraplegia to 45.3 for those with incomplete thoracic lesions. The MCID of self-care varied from 3.3 to 8.5 and from 10 to 18 for respiration and sphincter management, depending on the level and severity of the lesion. With regard to mobility (room and toilet), the MCID varied from 1 to 3 and from 2.5 to 7.26 for mobility (indoors and outdoors). The aROC was between good and excellent for all these values. CONCLUSIONS: The results provide benchmarks for clinicians and researchers to interpret whether patients' change score on the SCIM III can be interpreted as true or clinically meaningful and to make clinical judgments about the patients' progress. CLINICAL REHABILITATION IMPACT: Our data could be useful for both clinicians and researchers. At the beginning of rehabilitation clinicians may have an idea of the minimal improvement of the patient (based on his neurological status) that could have an impact on patient's life. At the end of rehabilitation process, it is possible to control if the patient achieved an improvement that is true and significant. Researchers could also use these criteria to evaluate the clinical significance of an intervention by calculating the number of subjects in the treatment and control groups (or in two different treatment groups) who achieved a change calculated as the natural recovery plus the MCID.
Authors: Ralph J Marino; Rebecca Sinko; Anne Bryden; Deborah Backus; David Chen; Gregory A Nemunaitis; Benjamin E Leiby Journal: Top Spinal Cord Inj Rehabil Date: 2018
Authors: Rutger Osterthun; Tjitske A Tjalma; Dorien C M Spijkerman; Willemijn X M Faber; Floris W A van Asbeck; Jacinthe J E Adriaansen; Marcel W M Post Journal: J Spinal Cord Med Date: 2018-08-20 Impact factor: 1.985
Authors: M J Mulcahey; Christina Calhoun Thielen; Cristina Sadowsky; Jennifer L Silvestri; Rebecca Martin; Lauren White; Julie A Cagney; Lawrence C Vogel; Jennifer Schottler; Loren Davidson; Ingrid Parry; Heather B Taylor; Kristine Higgins; Michelle L Feltz; Rebecca Sinko; Jackie Bultman; Jenny Mazurkiewicz; John Gaughan Journal: Spinal Cord Date: 2017-12-22 Impact factor: 2.772
Authors: Max O Krucoff; Robert Gramer; Dana Lott; Emily Kale; Amol P Yadav; Muhammad M Abd-El-Barr; Saurabh R Sinha; Shivanand P Lad Journal: Spinal Cord Ser Cases Date: 2020-10-16