Original Title: Herramientas para la detección precoz del malestar emocional en personas adultas con cáncer

Authors' objectives: To provide an evaluation of the characteristics and psychometric properties of tools for the early detection of emotional distress in adult cancer patients validated in the Spanish context that can be used in the context of the National Health System (SNS).

Authors' results and conclusions: As a result of the guideline search strategy, 6 CPGs were taken into account to address the domains related to the description of the health problem, description and technical characteristics of the technology, as well as to analyse implementation considerations (organisational, ethical and social aspects and related to the patients’ view). As results of the search for studies, 15 validations of tools for early detection of emotional distress in adult cancer patients were included. A total of 7 scales were evaluated: the Visual Analogic Scale (VAS) for anxiety and depression, the Distress Thermometer (DT), the Detection of Emotional Distress (DED) scale, the Brief Symptom Inventory-18 (BSI-18), the Edmonton Symptom Assessment Questionnaire - Revised (ESAS-r), the Hospital Anxiety and Depression Scale (HADS) and the Psychosocial and Spiritual Needs Evaluation scale (ENP-E). According to the length of the scale, 3 of the tools evaluated (VAS of anxiety and depression, DT and DED scale) are ultra-short (specifically between 1 or 2 items), and 4 of them (BSI-18, ESAS-r, HADS and ENP-E) are short (specifically between 10 and 18 items). Regarding the validation sample, 3 scales (DT, BSI-18 and HADS) were validated by three or more studies, with heterogeneous samples of cancer patients at different stages of the disease; while 4 scales (VAS for anxiety and depression, DED Scale, ESAS-r and ENP-E) were validated through a single study for each scale with oncological-palliative patients. According to the QUADAS-2 tool for assessing the quality of diagnostic accuracy studies, there are no concerns about the risk of bias or the applicability of their results in the validation study of the VAS for Anxiety and Depression, four of the five validation studies of the DT, two of the three validation studies of the BSI-18 and one of the three validation studies of the HADS. The remaining studies raise concerns about either the risk of bias or the applicability of their results. With respect to the psychometric properties analysed, the validation studies of the DT do not calculate either its internal consistency or its factorial structure, given that it is made up of a single item. In turn, the convergent validity of the test is assessed in all validation studies, reporting moderate positive correlations with other measures such as the BSI-18, the emotional problems included in the Problem List, or the HADS. The validation study of the VAS of anxiety and depression reports neither their internal consistency nor their factorial structure, understanding them as complementary measures, but not belonging to the same scale. However, it does analyse their convergent validity through the calculation of positive correlations of Global Emotional Distress (DEG) or score obtained from the sum of the VAS scores with the total HADS score, as well as between the anxiety VAS and the HADS anxiety subscale, and between the depression VAS and the HADS depression subscale. As regards the DED scale, its internal consistency (α = 0.685) is low, although this value is close to the minimum acceptable (α = 0.7), especially considering that the instrument consists of only two items. The validation study of this tool reports its convergent validity through the calculation of intraclass correlation coefficients (with the DT, the HADS and its subscales, as well as with a clinical psychological assessment), which are positive. Validation studies of the BSI-18 report acceptable internal consistency (α between 0.82 and 0.91), provide evidence of convergent validity and confirm a hierarchical structure with three first-order factors (anxiety, depression and somatization subscales) and a second-order factor as a measure of emotional distress (the Global Severity Index -GSI-). The ESAS-r also has an acceptable internal consistency (α = 0.86), but it does not analyse either the construct validity or the convergent validity of the scale. With reference to the HADS, the values provided by the validation studies on its internal consistency are acceptable (α > 0.80) and the underlying structure found in two of the studies is bifactorial, consisting of the anxiety and depression subscales. The other validation study finds a hierarchical solution with two first-order factors (anxiety and depression), and a second-order factor (total score) as a measure of emotional distress. In addition, one of the studies also provides evidence of convergent validity for each subscale. In the case of the ENP-E, the validation study reports acceptable internal consistency (α = 0.75) and an underlying four-factor structure, consisting of the subscales of emotional well-being, social support, spirituality and information. With regard to the convergent validity of the scale, the correlation coefficients calculated with the HADS and the DT were positive. The discriminative capacity of any of the early detection tools analysed proved to be good (with the area under the curve showing values above 0.80 in all cases). For the BSI-18 and ESAS-r, the discriminative capacity was not calculated due to lack of a reference test. The overall assessment of each scale was based on a combined evaluation of its reliability, type of criterion measure used, sample sizes and validity of each scale (mean value of its sensitivity and specificity). Following this multi-criteria assessment, three scales were rated as poor (VAS of anxiety and depression, BSI-18 and ESAS-r), one scale was rated as acceptable (ENP-E) and three scales obtained a moderate rating (DT, DED scale and HADS). The organisational impact of introducing tools for the early detection of emotional distress could be substantial, especially if it is introduced as part of a screening or systematic evaluation programme. Different CPGs recommend the creation of working teams to coordinate and direct its implementation, with a psychologist among their members. From an ethical point of view, the use of a tool for the early detection of emotional distress meets the requirement that the benefit outweighs the possible side effects. Other ethical considerations such as respect for autonomy and the right to privacy and confidentiality and equity of access must also be taken into account. With regard to patients’ views, hardly any information on acceptability, satisfaction or patients’ perspectives has been identified in the CPGs retrieved or in the studies analysed. Conclusions: When choosing one or another tool for the early detection of emotional distress in adults with cancer, aspects such as the objective of early detection, the length of the scale, the stage of the disease in which the patients are, the assessment of the risk of bias of the studies and the overall assessment of the scale should be considered. • All things considered, the distress thermometer (with a cut-off point ≥ 5) stands out as a tool for the early detection of emotional distress because of its brevity (1 item), because it has been validated in studies with a low risk of bias and whose samples come from cancer populations at different stages of the disease, and because it has a moderate overall assessment of the scale. This single-item measure has a high sensitivity and low specificity, so it could be considered as a useful first stage screening measure to rule out clinical distress, combined later with a longer scale, which would help to improve the specificity of the screening as a whole. For this purpose, the HADS scale stands out. • It is important to stress the importance of using the tools for the early detection of emotional distress within the framework of a structured screening programme coordinated by a multidisciplinary team that includes a psychologist, as well as a referral protocol that ensures specialised psychosocial care for those patients who need it. • It would be advisable to implement studies that comprehensively assess the psychometric quality and diagnostic accuracy of tools for the early detection of emotional distress, as the number of studies is small and, in some cases, incomplete because they do not include a reference test, which is particularly necessary in the case of the BSI-18. Future research would also need to give more attention to issues related to the implementation and acceptability of the tools by patients, especially taking into account social and cultural diversity, and the specificities of disadvantaged groups or people with disabilities.

Authors' methods: Following a preliminary literature search of clinical practice guidelines (CPGs) and health technology assessment reports (conducted in October 2021), two specific search strategies were designed in the main biomedical databases: a first one for the location of clinical practice guidelines that address emotional distress in cancer patients (November 2021), and a second one with the objective of locating those primary studies of elaboration and validation of tools in the Spanish context, as well as those of cross-cultural adaptation and validation of tools to the Spanish context (in December 2021). This process was completed by creating alerts in the main databases (Medline, Embase and WoS) in order to retrieve all relevant studies that could be published during the drafting of the report. The alerts remained active until the date of publication of the report. After reading the titles and abstracts of the articles resulting from the search, a selection of studies was made according to the previously established inclusion and exclusion criteria. The selection of studies, data extraction and evidence synthesis process was peer-reviewed. The information was synthesised in evidence tables using the FLC 3.0 tool and adapted to the specific objectives of this report. The quality of the evidence of the studies was assessed using the QUADAS-2 tool for diagnostic efficacy studies. An overall assessment of each of the scales was also carried out, taking into account reliability, the type of criterion measure used, the sample sizes and the validity of each scale. The assessment of biases and applicability of the studies, as well as the overall assessment of the scales, was peer reviewed. The method for resolving disagreements in all phases was consensus. In order to analyse the aspects related to the patients’ perspective, the information on this subject was analysed both in the CPGs considered and in the primary studies included. In addition, this report was reviewed by 3 patient representatives from the Spanish Association Against Cancer (AECC).

Project Status: Completed

URL for project: https://acis.sergas.es/cartafol/Estamos-traballando-en

Year Published: 2023

URL for published report: http://hdl.handle.net/20.500.11940/17941

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Scientific Advice Unit, avalia-t; The Galician Health Knowledge Agency (ACIS)

Contact Address: Conselleria de Sanidade, Xunta de Galicia, San Lazaro s/n 15781 Santiago de Compostela, Spain. Tel: 34 981 541831; Fax: 34 981 542854;

Contact Name: avalia_t.acis@sergas.es

Contact Email: avalia_t.acis@sergas.es

Copyright: <p>Galician Agency for Health Technology Assessment (AVALIA-T)</p>