SECONDs' Italian Translation and Transcultural Validation (IT-SECONDs)

Italian Translation and Transcultural Validation of the Simplified Evaluation of Consciousness Disorders (SECONDs) Scale: a Multicentre Study

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

Study Overview

• Status: Recruiting
• Conditions: Disorder of Consciousness

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).

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Italy
  • Florence, Italy, 50143
    • Recruiting
    • IRCCS-don Gnocchi Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The concurrent validity of the transcultural adaptation of the SECONDs scale with the CRS-R (correlation coefficient for Spearman's ranks)	The endpoint of the study is the creation of a valid and reliable transcultural adaptation of the SECONDs scale	21 months
the indexes of agreement between inter and intra examiners (index K)	The endpoint of the study is the creation of a valid and reliable transcultural adaptation of the SECONDs scale	21 months

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus
• Collaborators: Carlo Besta Neurological Institute

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2021
• Primary Completion (Actual): June 15, 2022
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Validation; diagnosis; Disorders of Consciousness; Scale
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Consciousness Disorders
• Other Study ID Numbers: IT-SECONDs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No