Transcultural adaptation and theoretical models of validation of the Spanish version of the Nurse´s Global Assessment of Suicide Risk scale (NGASR): Procotol for a multicentre cross sectional study (Preprint)

BACKGROUND Nowadays, suicide is a public health issue for which prevention and treatment must be prioritized by macro-, meso- and micro-management in health programs developed worldwide [1]. Suicidal behavior is determined by a complex interplay of factors that pose a risk for the development of lethal behavior; risk factors and predisposing circumstances that may determine and precipitate suicidal behavior and protective factors that provide life-sustaining safety [2-3] The World Health Organization (WHO) estimates that almost 800.000 people commit suicide every year worldwide and, for every one of these suicides, it is estimated that there are 20 suicide attempts [4], so can estimate that there are more than 16 million suicide attempts every year worldwide. Suicide attempts are repeated by 15%-30% of patients within one year, and almost 2% end up committing suicide within 5-10 years of their initial suicide attempt [5]; the suicide attempt is therefore the most relevant risk factor [6]. Internationally, the countries with the highest suicide rates are Lithuania, South Korea and Slovenia, where the suicide rate exceeds 30 cases per 100.000 inhabitants; while Greece, Turkey and South Africa appear at the bottom of the list with rates below 4 deaths per 100.000 inhabitants [7]. In Spain, more than 3.500 people commit suicide every year, and this has been on an upward trend since 2014 and a rate that exceeds 10 suicides per 100.000 inhabitants [8]. The highest suicide rates per inhabitant and autonomous community are in Asturias, Galicia and Murcia; while Cantabria, Ceuta and Melilla have the lowest rates. Both nationally and internationally, hanging and jumping from a height are the most commonly selected methods [7]. Both nationally and internationally, hanging and jumping from a height are the most commonly selected methods [7]. Risk assessment scales for suicidal behavior are instruments available for healthcare providers in clinical practice and research, that guarantee quality standards in the results of their measurement, systematizing and universalizing the perceived observations. In order to support the healthcare professional in systematizing and assessing suicidal risk, determining the most appropriate intervention, as well as how to record the case and the care provided, it is important to know and use validated suicide risk assessment scales that will always require prior consultation with the patient and clinical interview [8,9]. Among the most commonly used scales are the Horowitz Suicide Risk Questionnaire [10], Beck Hopelessness Scale [11], Beck Scale for Suicide Ideation [12], Hamilton Depression Inventory [13], Plutchik Suicide Risk Scale [14], Reasons for Living Inventory [15] and the Nurses' Global Assessment of Suicide Risk scale (NGASR) [8].The NGSAR scale, which is noted for its ease of use [16], has been included as a suitable tool for assessing suicide risk in the Registered Nurses Association of Ontario (RNAO) best practice manuals [17]. In Spain, nurses are the first line of care, therefore, having a scale with good psychometric properties in assessing suicide risk becomes essential. Taking into account the relevance and wide use of the NGASR in clinical practice and research, and being validated in different languages such as German, Mandarin Chinese, Portuguese, Korean and Italian with good validity and reliability [8,16-26], the aim of this work is to translate and adapt this scale in Spanish, second most spoken language in the world [27], as well as to evaluate its psychometric properties in patients with risk factors and suicidal behaviors. OBJECTIVE The aim of this study is to translate and adapt this scale for the Spanish population as well as to evaluate its psychometric properties in patients with suicide risk factors. METHODS Search strategy Initially, a review of the literature will be conducted in order to learn about previous in other languages about psychometric characteristics of the “Nurses Global Assessment of Suicide Risk” (NGASR). A search of articles indexed in major health science databases. In addition, the bibliographic references of the reviews included will be searched. The results will be assessed for inclusion by two independent reviewers, as well as the assessment of methodological quality and data extraction. A search of the scientific literature will be conducted based on the following keywords: Suicide Attempted, Nurse, Risk Assessment, Risk, Scale, NGASR. They shall be combined by means of Boolean operators (“AND” and “OR”) and adapted to each database in a specific way. The literature review procedure followed in this protocol is described in Figure 1.Translation, adaptation and modelling. Before testing its psychometric properties, the NGASR scale, will be translated and culturally adapted from its original English version into Spanish. The NGASR scale (table 1) was developed by Cutcliffe in 2004 and consists of 15 items, each of which has a score of 1 or 3 points. Variables such as hopelessness, depressive symptoms, suicidal plan, grief process and history of previous suicide attempt are scored with 3 points; while the rest of the variables are scored with 1. A final score of 0 to 5 points indicates low risk; 6 to 8, intermediate risk; 9 to 11, high risk; and equal to or greater than 12 indicates a very high level of suicide risk. These items are designed so that during the interview the nursing staff can collect the necessary information for each of the variables Table 1. The Nurses’ Global Assessment of Suicide Risk (NGASR) Cutcliffe,2004. We follow the guidelines published by Beaton et al. [33] will be followed, which divide the process into six steps: translation, synthesis, back-translation, back-translation synthesis, expert review of the translated version, and pretesting. For this purpose, a nursing professional expert in mental health and a bilingual nursing professional will lead, respectively, two independent groups that will carry out a first Spanish version (V1-group A and V1-group B). After comparing the two versions and in order to reach consensus on the discrepancies, the criteria of both groups will be unified and a final version of the document will be created in Spanish (NGASR-SPN) which will be back-translated into English by an official entity that certifies this process. The back-translated version (NGASR-SPN) will be provided to the original author to confirm the accuracy of the instrument. The NGASR-SPN will be evaluated by 10 nurses from the mental health field with more than 5 years of experience. Participants in the validation process A sample of 150 patients admitted to one of the units of the La Rioja Mental Health network will be recruited, comprising the Primary Care Mental Health Units; Day Hospital; Partial Hospitalisation Unit; Short Stay Hospitalisation Unit, Medium Stay Hospitalisation Unit and Long Stay Hospitalisation Unit. The patient will be informed of the objectives and methodology of the work, requesting their free, voluntary and informed consent, with guarantees of data confidentiality and with the use of the information obtained exclusively for research purposes, all in accordance with Organic Law 3/2018, of 05 December, on the Protection of Personal Data and guarantee of digital rights, and Regulation 2016/679 of the European Parliament and of the Council, of 27 April 2016, on the protection of natural persons with regard to the processing of personal data and the free movement of such data. Inclusion criteria for participation in the study will be: - Patients diagnosed with a mental disorder according to the clinical descriptions and diagnostic guidelines of the 11th revision of the International Classification of Diseases - ICD [30] and the Diagnostic and Statistical Manual of Mental Disorders - DSM-V [31]. - Be under follow-up or treatment in one of the mental health departments of La Rioja Health Service. Exclusion criteria: - Civilly incapacitated patient. - Patients with cognitive or perceptual impairment. - Patient whose main language is not Spanish. The sample size (150 patients) was estimated according to the criteria for a factor analysis with a minimum of 10 subjects for each item [32]. RESULTS The psychometric analyses of the Spanish version of the NGASR will include tests of reliability and validity of its internal structure. The reliability of the scale will be assessed by exploring internal consistency, and calculating Cronbach's alpha coefficient, with significance values of 0.70 or higher being accepted as an indicator of good internal consistency [34]. The underlying factor structure of the NGASR scale in Spanish will be assessed by exploratory factor analysis. To assess the relevance of performing an exploratory factor analysis on the sample, the Kaiser-Meyer-Olkin (KMO) measure of sample adequacy and Bartlett's sphericity statistic will be calculated beforehand. The adequacy of the sample for these analyses will be determined with optimal values for KMO and in the case of Barlett's test of sphericity, the null hypothesis of sphericity of p<0.05 will be rejected to ensure that the correlation matrix is adequate to obtain a factor model able to properly describe the data. The data will be coded and recorded in computer format. Data processing and statistical calculations will be carried out with the SPSS STATISTICS software [35]. CO

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