Clinical trial NCT05714215: SECONDs' Italian Translation and Transcultural Validation
Official title: Italian Translation and Transcultural Validation of the Simplified Evaluation of Consciousness Disorders (SECONDs) Scale: a Multicentre Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Disorder of Consciousness
Keywords: Disorders of Consciousness
Scale
Validation
diagnosis
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Carlo Besta Neurological Institute
First posted: 2023-02-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: For the pilot intra and inter-rater validation study (Phase 2A), the enrollment of 10 consecutive patients (5 Florence, 2 Sant'Angelo and 3 Besta) is envisaged, subject to the signature of the informed consent of the legal representative.

For the second phase of multicentre validation, the recruitment of 60 consecutive or distributed patients is foreseen, Florence: 28; Sant'Angelo: 10 and Istituto Besta: 22.

Brief summary: The coma recovery scale-revised (CRS-R) is the recommended diagnostic scale for consciousness but it requires time, training, and provides total scores that do not always reflect the correct level of consciousness. Recently, a new short-term assessment tool for consciousness assessment has been validated, which could easily be implemented in daily practice to determine the level of consciousness in severely brain injured individuals: the simplified evaluation of consciousness disorders (SECONDs) .Its administration should be significantly shorter than CRS-R and accurate to allow monitoring of consciousness in the subacute / chronic phase. The SECONDs scale was constructed by selecting the items that, based on the latest scientific evidence, are most frequently associated with a minimally consciousness state. In fact, recent studies have shown that 5 items of the CRS-R allow to identify 99% of individuals with minimally consciousness state 1) reproducible movement on command, 2) visual pursuit 3) visual fixation 4) automatic motor response, and 5) localization to pain) 12. In addition, some changes have been introduced such as 1) the assessment of fixation and visual tracking through the use of the mirror 2) the use of autobiographical questions for the assessment of communication 3) the reduction of the number of orders on command to 2 of 3 instead of 3 out of 4 as in the CRS-R. All these changes have been made to minimize time for administration without compromising the accuracy of consciousness detection, to improve feasibility in clinical practice, and also to limit fatigue, which could produce better patient concentration and collaboration.

The aim of the multicentre study is to carry out a cross-cultural translation of the SECONDs assessment scale into Italian and to perform a validation between operators of different professions of the Italian version. validation will be conducted on a group of patients with prolunged disorders of consciousness in the subacute phase admitted to two units of severe acquired brain injuries of the don Carlo Gnocchi Foundation of Florence and Sant'Angelo dei Lombardi, and in the chronic phase IRCCS foundation Carlo Besta neurological institute

Detailed description: The first phase involves the Italian translation of the SECONDs scale through a rigorous multi-stage review and the drafting of the working and final versions. First, the original scale will undergo a forward translation into Italian by a certified translator. The Italian version obtained will then be discussed by the team of experts from the 3 centers participating in the study for transcultural adaptation. Then the revised Italian version will be subsequently back translated into the original language by another certified translator blinded from the original version. Any discrepancy will be thoroughly discussed between the interdisciplinary Italian group and with the external expert from the group that originally developed the scale, and the Italian version shall be re-defined, with the aim of determining the conceptual, semantic, and operational equivalence of the translated scale. (Phase 1) The second phase involves a pilot study in which the final Italian version of the identified scale will be administered to a small group of patients to determine its intra and interoperative validity (Phase 2A) Subsequently, the multicentre validation of the Italian scale is envisaged on a larger group of patients, 38 admitted to inpatient intensive rehabilitation in the subacute phase (don Gnocchi foundation) and 22 admitted to outpatient rehabilitation in the chronic phase (Istituto Besta) (Phase 2B).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of severe acquired brain injury
* Diagnosis of a disorder of consciousness

  •\> 28 days from the acute event
* age\> 18 years
* No history of neurological or psychiatric deficits
* Mother tongue: Italian
* Clinical stability (eg, absence of mechanical ventilation, sedation, infection, ensuing seizures).
* Signature of the informed consent by the legal representative

Exclusion Criteria:

• Appearance of a second brain event

Primary outcomes:
measure: The concurrent validity of the transcultural adaptation of the SECONDs scale with the CRS-R (correlation coefficient for Spearman's ranks)
timeFrame: 21 months
measure: the indexes of agreement between inter and intra examiners (index K)
timeFrame: 21 months
Secondary outcomes:
Other outcomes:
Locations:
city: Florence
country: Italy
facility: IRCCS-don Gnocchi Foundation
Study officials:
affiliation: IRCCS-Fondazione Don Gnocchi-Florence
name: Bahia Hakiki, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS-Fondazione Don Gnocchi-Florence
name: Bahia Hakiki, Dr
role: STUDY_DIRECTOR
References:
citation: Aubinet C, Cassol H, Bodart O, Sanz LRD, Wannez S, Martial C, Thibaut A, Martens G, Carriere M, Gosseries O, Laureys S, Chatelle C. Simplified evaluation of CONsciousness disorders (SECONDs) in individuals with severe brain injury: A validation study. Ann Phys Rehabil Med. 2021 Sep;64(5):101432. doi: 10.1016/j.rehab.2020.09.001. Epub 2021 Jul 28.
citation: Giacino JT, Kalmar K, Whyte J. The JFK Coma Recovery Scale-Revised: measurement characteristics and diagnostic utility. Arch Phys Med Rehabil. 2004 Dec;85(12):2020-9. doi: 10.1016/j.apmr.2004.02.033.