Awareness of cognitive abilities in the execution of activities of daily living after acquired brain injury: an evaluation protocol

1 MerchánBaezaJA, etal. BMJ Open 2020;10:e037542. doi:10.1136/bmjopen-2020-037542 Open access Awareness of cognitive abilities in the execution of activities of daily living after acquired brain injury: an evaluation protocol Jose Antonio MerchánBaeza,1 Maria RodriguezBailon ,2 Giorgia Ricchetti,3 Alba NavarroEgido,3 María Jesús Funes3 To cite: MerchánBaezaJA, RodriguezBailonM, RicchettiG, etal. Awareness of cognitive abilities in the execution of activities of daily living after acquired brain injury: an evaluation protocol. BMJ Open 2020;10:e037542. doi:10.1136/ bmjopen-2020-037542 ►Prepublication history and additional material for this paper are available online. To view these files, please visit the journal online (http:// dx. doi. org/ 10. 1136/ bmjopen2020037542). Received 06 February 2020 Revised 26 August 2020 Accepted 02 September 2020 For numbered affiliations see end of article. Correspondence to Dr Maria RodriguezBailon; mariarbailon@ uma. es Protocol © Author(s) (or their employer(s)) 2020. Reuse permitted under CC BYNC. No commercial reuse. See rights and permissions. Published by BMJ. ABSTRACT Introduction One of the main limitations that can be observed after acquired brain injury (ABI) is the alteration of the awareness of the deficits that can occur in the cognitive skills necessary for performing activities of daily living (ADL). According to the Dynamic Comprehensive Model of Awareness (DCMA), consciousness is composed of offline component, which contains the information stored about characteristics of the tasks and stable beliefs about one’s own capabilities and online awareness, which is activated in the context of the performance of a specific task. The main objective of this project was to generate and validate a detailed cognitive assessment protocol within the context of ADL to evaluate the components of DCMA. Methods and analysis The proposed protocol consists of two ecological tools: The CogAwareness ADL Scale to measure offline component and the Awareness ADLtask: Basic and Instrumental ADL performancebased test to measure online awareness. The aim is to identify the presence of cognitive deficits and anosognosia in patients with ABI within the context of everyday life activities. These two measures will be administered to a group of patients with ABI. In addition, these participants will complete another series of classic tests on anosognosia and cognitive functions in order to find the convergent validity of the two tests proposed in this protocol. The external validity of the CogAwareness ADL Scale and the relationships between awareness components within the same ADL domain will be also analysed. Ethics and dissemination This study was approved by the Ethics Committee of Biomedical Research of Andalusia, on 13 January /2017 (Proceeding 1/2017). All participants are required to provide written informed consent. The findings from this will be disseminated via scientific publication. Trial registration number NCT03712839. BACKGROUND Patients with acquired brain injury (ABI) usually suffer severe cognitive deficits that affect their independent performance of activities of daily living (ADL). In some cases, they also show anosognosia, a clinical condition characterised by the lack of awareness of their own cognitive deficits, with a major impact on rehabilitation and patient’s reintegration in the community.1 Indeed, patients with unawareness of their limitations usually produce unsafe behaviours and have a poor treatment adherence, as they believe it is unnecessary, leading to worse functional outcomes and increasing caregiver’s burnout.2–4 Awareness of cognitive deficits is strictly related to the concept of metacognition: the knowledge about one’s own cognitive functioning. The first theoretical models of metacognition describe it as being composed of different levels, that is, general ‘offtask’ knowledge and specific ‘ontask’ information, and account for a constant flow of information between these components.5 6 Similar characteristics can also be found in several selfawareness models.7–9 According to one of the most comprehensive theoretical models proposed by Toglia and Kirk,9 that is, the Dynamic Comprehensive Model Strengths and limitations of this study ►The protocol presented here raises a global approach to measure the main components of selfawareness related to the execution of activities of daily living (ADL). ►The tools designed for this protocol to provide a similar coding system of ADL error types in order to facilitate the comparison and interpretation of potential patterns of relationship or divergence among components. ►The online tasks proposed in this protocol include the presence of conflicting/problemsolving situations, thus, all the participants will face the same number of problems, errors to solve and objects to ignore. ►This protocol does not aim to assess the information stored in longterm memory about characteristics of the tasks. 750. Protected by copyright. on November 26, 2020 at Granada/Medicina/CC Salud PO Boxhttp://bmjopen.bmj.com/BMJ Open: first published as 10.1136/bmjopen-2020-037542 on 26 October 2020. Downloaded from 2MerchánBaezaJA, etal. BMJ Open 2020;10:e037542. doi:10.1136/bmjopen-2020-037542 Open access of Awareness, consciousness is composed of two separate components: metacognitive knowledge and online awareness. ‘Metacognitive knowledge’ is the offline component of consciousness and contains the information stored in longterm memory about characteristics and demands of the tasks we usually carry out, how we perform them and the cognitive resources available in order to correctly complete them. This component is formed by almost stable beliefs about one’s own capabilities based on past experiences. The second component, that is, online awareness, is activated in the context of the performance of a specific task. The online component comprises additional subcomponents: ‘anticipatory awareness’, ‘emergent awareness’, ‘selfregulation’ and ‘selfevaluation’ skills. Anticipatory awareness is described as the ability to predict situation demands and one’s own performance in the current task, emergent awareness refers to the process of error detection during the activity and selfregulation is the capability to adapt and adjust the behaviour to correct detected errors. Once the task is completed, a selfevaluation process might begin, by appraising the current performance and comparing it with the expected performance.9 According to this model, offline and online components might dynamically interact and depend on task characteristics such as familiarity, complexity and its value for the person. The prediction of one’s own performance depends on task information stored in metacognitive knowledge and affects the monitoring resources devoted to the task. At the same time, a correct online error recognition might enable the selfregulation process during the performance and a correct selfevaluation following the task. The information obtained during selfevaluation is important in order to change and update metacognitive knowledge if a discrepancy is found between the expected (or anticipated) performance and the actual performance; this process determines the way in which the person will face the same activity in the future.9 Based on this model, one straightforward conclusion is that anosognosia could arise due to different causes. Indeed, a poor error detection ability during the task can lead to the lack of awareness about limitations and problems for task performance.10 11 These authors have found that error detection abilities are strongly related to attention and cognitive control, measured with neuropsychological tests and experimental computerbased tasks. On the other hand, a failure in selfevaluation and updating processes could also lead to anosognosia in patients with acquired brain damage.12 13 In this case, the lack of awareness is expected to be related to memory consolidation impairment, and even when patients are able to detect their own errors during online task performance, such information cannot be integrated with their metacognitive knowledge. Therefore, the patient’s own image clings to the past and the new limitations raised after the damage cannot be incorporated into the metacognitive knowledge, leading to the socalled ‘petrified self’, which has been often described in studies with dementia patients.14 15 Altogether, we can sum up that anosognosia for cognitive deficit after brain damage is a complex phenomenon that might appear due to the alteration of different components. Isolating which components are mostly responsible for anosognosia on a given acquired brain damage patient seems crucial for targeting efficient and personalised rehabilitation programmes. In order to advance on the knowledge of the different components of anosognosia, the pattern of relationship among them and with other cognitive processes, and its different manifestations in different brain lesioned patients, we need to develop new evaluation tools that provide a comprehensive measure of all the potential components and manifestations of the phenomenon within a given patient. However, as is fully described in the next section, most studies have used isolated measures that focus on a given component (mostly on the offline component), and very few have included a multidimensional approach with intraindividual measures of several components or manifestations. In addition, the tests used to measure different components are usually very different, with the offline component being typically measured with questionnaires about ADL functionality, and the online component being measured with artificial neuropsychological tests or computerbased tasks, where participants are required to answer with simple key press responses according to new and arbitrary stimulusresponse mappings. Assessment of awareness components Regarding the offline component of anosognosia, its assessment is usually questionnaire based.16 In these questionnaires, the patient and a caregiver answer the same questions about the patient’s difficulties with performance in certain daily tasks or with specific cognitive and emotional functions. The presence of a discrepancy between the two parts of the questionnaire (patient vs caregiver), where the patient under/overestimates his/ her difficulties, is considered as an indicator of unawareness of his/her acquired limitations and deficits.1 This kind of measure is useful to evaluate the offline metacognitive knowledge component (in the Toglia and Kirk model), since it assesses the patient’s stable beliefs about his/her capabilities and limitations. These measures are usually the ones considered to make a diagnosis of anosognosia. There are several questionnaires of this sort. Among them, one of the most used is the Patient Competency Rating questionnaire, which determines a cutoff point (>5) in its discrepancy index to establish the existence of anosognosia.1 However, most of these questionnaires do not dissociate among different cognitive manifestations of anosognosia, as they are rather based on global measures of cognitive ADL functioning. Therefore, in order to study whether anosognosia is domain general or domain specific, separate scales are required to be administered to test the selfawareness of different cognitive processes and different ADL.17 Given recent evidence according to which patients 750. Protected by copyright. on November 26, 2020 at Granada/Medicina/CC Salud PO Boxhttp://bmjopen.bmj.com/BMJ Open: first published as 10.1136/bmjopen-2020-037542 on 26 October 2020. Downloaded from 3 MerchánBaezaJA, etal. BMJ Open 2020;10:e037542. doi:10.1136/bmjopen-2020-037542 Open access can be differently unaware of different cognitive manifestations,18 19 it seems necessary to develop new tools sensitive to several potential sources of deficit in metacognitive consciousness among patients. Even further, global measures of cognitive ADL functioning do not allow studying whether patients are more or less aware of their cognitive deficits when performing basic versus instrumental ADL (IADL vs BADL) or testing anosognosia on severely affected patients who cannot perform complex tasks due to their cognitive and/or physical alterations. Regarding the measurement of online components of anosognosia, very different strategies and tasks have been used. For example, in metamemory research, online awareness is assessed by asking participants to estimate the likelihood of studied items to be recalled (Judgement of Learning, JOL) or recognised (Feeling of Knowing, FOK) and to rate their confidence about the correctness of a previous response (retrospective confidence judgement, RCJ).6 20 These measures have been adapted and used to assess anticipatory awareness and selfevaluation in different domains by asking participants to predict their performance right before beginning the task and to selfevaluate their performance immediately after the completion of the task. The discrepancy between the patient’s prediction or selfevaluation and the actual performance or therapist evaluation is considered a measure of anticipatory awareness and selfevaluation, respectively. As in the case of JOL, FOK and RCJ, the object of this pre–post evaluation is usually performance in neuropsychological tests (memory, attention, executive functions and perception tests),11 21–25 and very few studies have used ADL tasks19 in populations with ABI.26 In the study conducted with ABI patients, anticipatory awareness was determined by calculating the discrepancy between the evaluations of the therapists about the actual performance and the prediction of the patients before conducting one BADL and two IADL. The discrepancy between the evaluation of the therapists about the actual performance and the patients’ estimation of how they performed the tasks immediately after conducting them was considered as a measure of emergent awareness. As a measure of selfregulation, the authors used the discrepancy between the evaluation of the therapists about the actual performance and the estimation of the patients after a process of joint review (therapists and patients) about the demands of the task, allowing for a review of performance. Other studies have also used ADL tasks (online shopping, using the phone, writing and reading) in other populations of patients.27 28 These two studies found an anticipatory awareness index between the patient’s prediction about his/her performance (difficulty, time, ability for similar tasks) and the actual performance. Moreover, a post or selfevaluation measure was found, comparing the patient’s estimation immediately after the task and the actual performance. All these studies measured the emergent awareness after the task was completed, whereas error detection and selfregulation (ie, error correction) needed to be measured during the actual performance. In this sense, from experimental psychology, artificial computerbased tasks (ie, Stroop like or go/No go tasks) have been used, in which different measures of online awareness can be obtained. For example, the socalled ‘PostError Slowing’ consists in an increment of reaction time after an error is made29 and is considered a selfregulation index, which reflects the adjustment of the performance when an error is detected, in order to avoid another error. Another way to measure emergent awareness is to directly ask the participants to verbalise whether their prior key press response was an error during simple go/nogo tasks.15 30 31 These measures have been recently used to identify impairments in emergent awareness and selfregulation processes in patients with ABI and neurodegenerative diseases.22 32–35 Some of these studies have used multidimensional approaches in order to see whether emergent awareness measured within the context of artificial tasks relate to offline measures of awareness on everyday functioning, with most showing independence among these measures15 (see, ref. 10 for evidence of a positive relationship between metacognitive knowledge and emergent awareness). One drawback of this approach is that offline and online measures of selfawareness are very different. Therefore, we cannot know whether a lack of relationship between offline and online measures indicates that anosognosia can arise due to different causes or that the performance on artificial computerbased tasks and neuropsychological tests might be different, in terms of processes, from the performance on everyday activities, conferring a low ecological validity to this type of task.36 37 In fact, patients do not usually have previous experience with this sort of artificial tasks and, as referred above, two of the aspects of the task that have been suggested to affect online processes are its familiarity and its significance. Therefore, the lack of prior representations in metacognitive knowledge about these artificial task characteristics and demands, and about the correct way to perform it, may reduce the patient’s capacity to correctly predict, monitor and evaluate the quality of his/her performance.9 Therefore, we consider that, in order to directly compare offline and online components of anosognosia within a given patient, it is necessary for both types of measures to ask about similar aspects of daily life. To our knowledge, very few studies have used direct measures of emergent awareness while patients perform significant ADL. These studies measure the ability of patients to detect and correct their own errors made spontaneously while making a coffee, a toast or a packed lunch.38–42 Most of these studies include a sophisticated error coding system, so that spontaneous errors can be coded as nondetected, detected and detected and corrected, based on participants verbalisations or actions towards correction.38 39 Consequently, they provide a direct measure of emergent and selfregulation components, respectively. Compared with the studies described above, this kind of assessment has a high ecological 750. Protected by copyright. on November 26, 2020 at Granada/Medicina/CC Salud PO Boxhttp://bmjopen.bmj.com/BMJ Open: first published as 10.1136/bmjopen-2020-037542 on 26 October 2020. Downloaded from 4MerchánBaezaJA, etal. BMJ Open 2020;10:e037542. doi:10.1136/bmjopen-2020-037542 Open access validity, since highly familiar everyday situations and their characteristics are reproduced in the laboratory.36 43 This allows directly evaluating how cognitive deficits and online awareness component failures affect daily activities in patients, without the need to infer them from artificial tasks.44 However, most of these studies using this ecological perspective to measure emergent awareness and selfregulation have been conducted in populations with neurodegenerative disease38 45 or schizophrenia.46 To the best of our knowledge, only two studies using this perspective have been carried out in patients with acquired brain damage.36 39 Doig et al36 evaluated online emergent awareness in two patients with brain damage during the realisation of several ADL, chosen in collaboration with the patient and his/her family. In addition to the total number of errors made, the authors also measured both spontaneous selfcorrected errors and the errors corrected after the therapist offered nonspecific or specific prompts (through the ‘pause, prompt, praise’ technique). The other study39 used the Multilevel Action Test to evaluate emergent awareness in patients with traumatic brain injury (TBI). The participants were asked to perform three ADL, such as wrapping a present, making a coffee and preparing a lunch box, but with four difficulty levels, including, for instance, distracting objects and time restrictions. The analysed variables included error detection and correction, as well as a measure of selfevaluation immediately after conducting the task. However, and despite the contribution of these studies to the analysis of this difficult construct, they did not evaluate the offline awareness component (metacognition). In conclusion, our search revealed that only few studies have provided a multidimensional approach to obtain measures of both online and offline components of anosognosia intraindividually. However, these measures are very different, with the offline component being usually measured with questionnaires about ADL functionality, while the online components are measured with computerbased artificial tasks or neuropsychological tests. Therefore, to date, no study has assessed all the potential components of awareness within the execution of the ADL. The present study The main general objective of this study was to generate and validate a detailed cognitive assessment protocol within the context of ADL to evaluate the different cognitive components of consciousness proposed by the Toglia and Kirk’s model (metacognitive knowledge, anticipatory and emergent awareness, selfregulation, selfevaluation and uploading processes). With this protocol, the aim is to analyse these components and understand how each of them can affect ADL performance. The proposed protocol consists of two ecological tools: The CogAwareness ADL Scale (ADL scale of metacognitive knowledge) and the BADL and IADL performancebased test (awareness ADL), to identify the presence of cognitive deficits and anosognosia in patients with ABI, always within the context of everyday life activities. One of the main characteristics of these tools is that they are designed to provide a similar coding system of ADL error types in order to facilitate the interpretation of potential patterns of relationship or divergence among them. Second, they are both designed to dissociate among different cognitive processes underlying errors in both BADL and IADL. Therefore, once validated, these tools could be used by future researchers to identify different subgroups of patients with different types of anosognosia. Thus, one of the main aims of the present study was to test the convergent and external validity of the two proposed ecological tools and to test their diagnostic ability to discriminate between patients with and without anosognosia and from healthy participants. We based the new scale to measure the offline component of awareness on the extended version of the Preliminary Cognitive Scale of BADL and IADL.47 This is an informantbased assessment tool that allows evaluating several cognitive abilities (eg, task schema, error detection, problem solving or task selfinitiation in a range of both BADL and IADL). Among other results, previous versions of this scale have shown good psychometric properties for a sample of mild cognitive impairment, dementia and healthy elder participants. A new version of this scale was created and administered for the first time to patients with acquired brain damage, to validate its capacity to measure metacognitive knowledge. To this end, two forms of this version were designed, one to be administrated to patients and the other one to direct caregivers, in order to obtain a discrepancy index. Cognitive items referring to ADL error types reflect the ADL error coding system normally used in online performancebased ADL tasks. Instead of including separate scales to test selfawareness of different cognitive processes 17, the CogAwareness ADL Scale helps to measure several cognitive functions and their level of awareness within a single test. Lastly, since the same cognitive items are evaluated in both BADL and IADL, the present questionnaire can identify potential differences in selfawareness when performing simple vs more complex tasks. Moreover, it can be applied more broadly, that is, to patients with brain damage even if at present they cannot perform IADL. We expect to find significant correlations between the discrepancy index of the CogAwareness ADL Scale and the discrepancy of the cognitive subsections and of widely studied ADL of classical measures, such as Patient Competency Rating Scale (PCRS). Likewise, we also expect to detect significant differences in this new offline functional awareness scale between patients with offline anosognosia, determined by PCRS (discrepancy index >5). We expect the CogAwareness ADL Scale to have a good sensitivity and specificity to determine this tool as a clinical diagnostic measure of offline functional awareness. The second part of the protocol includes two performancebased ADL tasks (Awareness ADL), one basic (dressup to get ready to go out) and one instrumental (prepare breakfast with a selfsqueezed orange 750. Protected by copyright. on November 26, 2020 at Granada/Medicina/CC Salud PO Boxhttp://bmjopen.bmj.com/BMJ Open: first published as 10.1136/bmjopen-2020-037542 on 26 October 2020. Downloaded from 5 MerchánBaezaJA, etal. BMJ Open 2020;10:e037542. doi:10.1136/bmjopen-2020-037542 Open access juice and butter and jelly toast), in order to measure the online components of selfawareness. Apart from target objects, highly semantically related but irrelevant objects (ie, distractors) are presented. In addition to distractors, several conflicting/problemsolving situations are included. This type of situations requires interrupting the automated sequence of actions and adding or modifying them to solve these conflicting situations in order to correctly complete the task. The reasons to include this kind of distracting and conflicting situations is threefold. On the one hand, we believe that encountering distractors and conflicting situations makes the ADL tasks more similar to real situations; therefore, they help to increase their ecological validity. Second, the inclusion of highly related distractors and conflicting situations seems to be a promising strategy to identify executive and metacognitive online deficits in patients with brain damage. Favouring this view, previous studies have shown that this kind of distractors have the potential to increase error rate by increasing actions towards them in patients with brain damage,48 dementia and cognitive mild impairment.49 50 In addition, previous work in our laboratory with a simpler version of this task (including the instrumental task only) discriminate between healthy participants and patients with and without anosognosia, constituting a more efficient and simpler way to identify diagnostic differences within ADL tasks, compared with previous coding systems based on spontaneous errors, which is very timeconsuming, as it usually requires video recording and a long training process. In addition to measuring the pattern of ADL errors and the ability to detect and correct them in both the BADL and the IADL tasks, the new online test includes measures of additional online components of awareness, such as anticipatory awareness, by asking the participants how they think they will perform the task (after a detailed explanation of the task to be performed, but before the actual performance) and selfevaluation, by asking how they think they did it immediately after conducting the task. The comparison between the preevaluation and the actual performance might reflect the ability of the participants to predict their own performance in the context of the specific task, taking in account its particular characteristics and demands (anticipatory awareness). Similarly, comparing the postevaluation with the actual performance allows assessing whether the participant’s explicit selfappraisal of the performance (essential information for the selfevaluation process) is coherent with the reality. Lastly, we will add a final estimation about their own performance 20 min after finishing the task in order to obtain a direct measure of the updating process and comparing immediate selfevaluation abilities and memory consolidation of such events. With this part of the protocol, we expect to find strong predictions of online measures that have been previously validated and used, such as the Weekly Calendar Planning Activity (WCPA),51 and an online measure based on the phonetic fluency test for the variables of detection and correction of errors made in the task of the awareness ADL designed for this protocol. Likewise, we expect to find relationships between the measures of selfevaluation and shortterm memory, and between updating capacity and measures of longterm memory. As stated in the introduction, the findings about whether the offline and the online awareness components are related to each other are contradictory, probably due to the fact that very heterogeneous tests have been compared. In addition, as far as we know, anticipatory awareness or selfevaluation have not been systematically studied in relation to other components from the model (ie, error detection, error correction or metacognitive knowledge). The protocol proposed in the present study might pose the ideal conditions to further test the Toglia and Kirk’s model regarding the different components proposed, and also to determine the interactions among them, as all measures are taken within the same ADL domain. This is the last aim of this study. METHODS AND ANALYSIS Design Validation of a protocol to evaluate functional anosognosia, analysing both its convergent and external validity through case–control retrospective observation. Participants Recruitment The sample of participants will be constituted by patients with ABI and healthy patients. The group of patients will be recruited from neurological rehabilitation services and associations of people with brain damage of Málaga and Granada, Spain. The group of healthy participants will be constituted by healthy adults of the same age, gender and educational level as the patients of the two groups with brain damage, who will be recruited in the previously mentioned cities via phone call or email. Younger healthy participants are being recruited through online advertisements using an online platform created by the Experimental Psychology Department at the University of Granada. Older participants were recruited either from the researchers and collaborators’ group of friends or relatives, who were verbally informed about the study and invited to receive further information. If they decided to participate, they contacted the researchers by telephone or email to schedule the first appointment. The occupational therapist in charge of managing the cases will provide the users of these services with a brief summary of the study and will identify possible candidates to participate in it. Those who offer their participation will be asked to provide verbal and written consent and their contact details to allow the coordinators of the project to contact them or their relatives. These, through phone call or email, will be informed about the study in detail and will be appointed for the first evaluation session. At the beginning of such session, the researcher will provide the participants with the sheet containing the 750. Protected by copyright. on November 26, 2020 at Granada/Medicina/CC Salud PO Boxhttp://bmjopen.bmj.com/BMJ Open: first published as 10.1136/bmjopen-2020-037542 on 26 October 2020. Downloaded from 6MerchánBaezaJA, etal. BMJ Open 2020;10:e037542. doi:10.1136/bmjopen-2020-037542 Open access information of the project and the consent form. They will be asked to sign and will be registered as participants of the study, so long as they are not excluded after the first screening tests. Eligibility criteria The participants will be included in the group of patients with brain damage if they are over 18 years of age and have suffered acquired brain damage (stroke or TBI). The study will exclude people with severe visuoperceptual deficit, which hinders the execution and completion of the ADL tasks and comprehension deficit, determined by the ability to understand and follow the instructions to complete the MiniMental State Examination (MMSE) (in case of doubt, the Boston Naming Test will be administered). The study will also exclude patients with hemispatial visual neglect, evaluated through cancellation tests and bisection lines, measured by a Behavioural Inattention Test,52 and/or motor deficits in both upper limbs, which makes it impossible for the patient to complete the ADL tasks. A cutoff point will be set at 18 or higher in the MMSE to participate in the study. Evaluation procedure and measures The professionals of the hospitals and associations will be the ones who will select the patients who meet the established inclusion criteria. Once they agree to contact the researcher, in the first session, after the participants sign the informed consent, the MMSE will be administered to confirm that each of these patients are candidates to enter the study. If a patient is considered a candidate, he/ she will be asked to provide his/her demographic data, such as sex, age and education level. For ABI patients, data about aetiology, time since injury and, when available, Glasgow Scale score at admission, will be collected. After gathering this information, the evaluation procedure will begin, which will be carried out in two or three sessions of approximately 1 hour each (depending on the capacity of the patient). First, the neuropsychological tests and the two offline awareness scales will be carried out. Then, the Awareness ADL will be conducted. The same researcher will carry out the entire evaluation, although blinded in terms of which patient group the participant belongs to, since the family member or caregiver’s evaluation will be archived and the PCRS discrepancy index will not be calculated until the end of this process. To explain the measures in a grouped manner, we present here three blocks (A, B and C), which correspond to the measures proposed in this protocol, the classical measures of offline and online awareness and the traditional neuropsychological tests. Ecological consciousness evaluation protocol proposed in the present study Metacognitive evaluation (offline): The Cog-Awareness ADL Scale This scale is based on the preliminary and extended version of the CogADL Scale.47 For the aim of this study, there will be two versions of the CogAwareness ADL Scale, one to be administered to a direct caregiver and the other to the patient, to observe the discrepancy index in terms of functionalitycognition. First, the scale includes several questions about the patient’s frequency (daily, weekly, sometimes or never) and degree of assistance (totally by him/herself, with little help, with a lot of help and someone does the activity for him/her) with which he/she usually does two BADL and two IADL (personal cleanliness, getting dressed, cooking and managing finances/shopping) before and after the brain damage (items 1 to 16). In the second part of the scale, this tool allows evaluating eight key cognitive aspects related to ability tasks: manipulation difficulties, action schema, distraction, substitution, repetition, error detection, problem solving and task selfinitiation in the two BADL and in the two IADL, respectively (34 items). Both patients and caregivers must answer how often the patients present this cognitivefunctional error in each of the 4 ADLs: (1) never, (2) sometimes, (3) quite often and (4) always. An example of the items presented in this part is: ‘I get distracted by other objects, touch them or even use correctly some other object in the bathroom that is not necessary for the personal hygiene activity that I am doing at that moment.’ The variables used for the analysis of the CogAwareness ADL Scale will be the cognitivefunctional errors made by the participants in BADL, on the one hand, and in IADL, on the other hand (see table 1). Evaluation of online awareness: The Awareness ADL The performancebased BADL and IADL test is based on tasks designed in our laboratory. According to preliminary data, these tasks are sensitive to the deterioration of executive functions caused by healthy ageing in the everyday context, and they can also be used to identify errors and the alteration of executive processes in patients with anosognosia. The novelty of this study is the addition of a basic task to evaluate the processes of selfawareness in patients with brain damage, as well as the inclusion of measures of the rest of the components of selfawareness proposed by Toglia and Klirk,9 such as anticipatory awareness, selfevaluation and updating. In this ecological evaluation, the participants will be asked to carry out two ADL: an instrumental activity (making breakfast) and a basic activity (dressing one’s upper trunk). The breakfast task will consist in making orange juice with a teaspoon of sugar and a toast with butter and jam. In addition to the thirteen objects required to complete this task, the participants will be presented with three distracting objects; together, these 16 objects will constitute the set needed to provoke a semantically related action, such as making a cup of white coffee, which the participants will not be ask to perform. All the objects will be randomly deployed on a table for each participant. Furthermore, the task was designed to generate four controlled conflicting situations: (1) the juice maker will be unplugged, with the cable hanging from the edge of the table; (2) the juice maker will be 750. Protected by copyright. on November 26, 2020 at Granada/Medicina/CC Salud PO Boxhttp://bmjopen.bmj.com/BMJ Open: first published as 10.1136/bmjopen-2020-037542 on 26 October 2020. Downloaded from 7 MerchánBaezaJA, etal. BMJ Open 2020;10:e037542. doi:10.1136/bmjopen-2020-037542 Open access Table 1 Proposed awareness tests created for this protocol and their correspondence to the traditional tests with the aim of finding their convergent validity Evaluated function Awareness ADL protocol proposed: ecological tools and variables used in the analysis Traditional tests and variables used in the analysis Offline component Metacognition The cogawareness ADL scale Discrepancy Index: The difference resulting from the score (cognitive functional error) obtained from the family member or caregiver minus the score obtained by the patient for these variables: ►(1) A total index result of the average of the scores of all items. ►Based on a previous study with this scale,42 an average of the scores of the items for (2) BADL (personal cleanliness, getting dressed), (min: 1max: 4) and (3) IADL (cooking and managing finances/shopping) will be made, (min: 1max: 4). Patient Competency Rating Scale 1. Discrepancy Index: The difference resulting from the score obtained from the family member or caregiver minus the score obtained by the patient in the following subsections: – ADL (min: −32, max: 32) – Cognitive (min: −32, max: 32) – Interpersonal (min: −28, max: 28) – Emotional (min: −28, max: 28) Online component Emergent awareness selfregulation The awareness ADL Classification errors based on previous studies39 45: ►Omissions: There is no necessary step to complete the task. Example: After having spread the butter on the toast, the patient does not spread the jam. (Min 0max 30) ►Substitutions: The patient substitutes an object with another one or a part of his/her body with an object (eg, he/she spreads the butter using the spoon). (Min 0No Max). ►Additions: The patient adds a step using a target object that is not necessary to perform the task, which involves loss of effectiveness but does not interfere with the task. Example: while the bread is being toasted, he/she removes it from the toaster and puts it back in. (Min 0No Max). ►Visuoconstructive/visuospatial failure: Failure to manipulate an object in space and/or with respect to the body. Example: the patient puts the juice maker upside down. (Min 0No Max). ►Repetitions: The patient repeats a step of the task already completed by inserting another step or action. Example: he/ she pours a teaspoon of sugar in the glass, pours the orange juice and takes a second teaspoon of sugar. (Min 0No Max). ►Perseverations: The patient repeats an action within a step, when it has already been completed. Example: he/she keeps squeezing an orange when juice no longer comes out. (min 0no max). ►Sequence failure: The steps of the task are performed in an illogical order. Example: the patient first spreads the butter and jam on the bread and then puts the toast in the toaster. (Min 0No Max). ►Tangential actions: Actions that are carried out with distracting objects to perform another task that is not the target task. Example: the patient performs one of the steps to make a coffee. (Min 0Max 19). ►Manipulations: The patient touches an object with no intention of using it to perform an action or a step of the task. Manipulations that are made to organise the space on the table are excluded. (Min 0No Max). Monitoring capacity (based on34) 1. Detected errors (%): It will be calculated from the total errors detected divided by the total errors made. Both errors caused spontaneously and those induced by situations of conflict are considered. (Min 0max 100).The errors detected can be categorised as any of these four types: – Error detected without correction attempts: An error made is verbalised to acknowledge that something is wrong (eg, ‘Oops’, ‘I was wrong’, ‘This does not work’) but the patient does not try to solve the error. (Min 0No Max). – Error detected with inefficient solution attempts. An error is made, it is detected and the patient tries to solve it without success or using too much time to solve it. (Min 0No Max). – Error detected and corrected effectively: An error is made, it is detected and it is successfully solved. (Min 0No Max). – Anticipated and solved conflict situation. The conflict situation is solved immediately before starting an action with the object involved. (Min 0Max 8). 2. Corrected errors (%): Sum of the spontaneous errors and conflict situations corrected effectively (or anticipated conflict situations), divided by the total number of errors and conflict situations detected. The errors solved effectively and the situations of conflict resolved with anticipation will be considered as corrected (for instance, before starting the activity, the patient detects that the juice maker is unplugged and then plugs it). (Min 0Max 100). Weekly calendar planning activity (Level I version A) 1. Number of strategies used (min 0no max) 2. Selfrecognition errors: if the patient attempted to correct an error during testing, verbalised acknowledgement of an error during testing, or reported the error following the completion of the task. (Min 0Max 10) Online awareness phonetic fluency test. 1. Sum of perseverations and intrusions in the task divided by the total number of attempts. (Min 0No Max). Anticipatory Awareness Anticipatory awareness questionnaire 1. Discrepancy index calculated from the score of the Likert scale (0–4) obtained from the score of the same Likert scale given by the patient before performing the task minus the actual performance. (Min: −4Max:4) Continued 750. Protected by copyright. on November 26, 2020 at Granada/Medicina/CC Salud PO Boxhttp://bmjopen.bmj.com/BMJ Open: first published as 10.1136/bmjopen-2020-037542 on 26 October 2020. Downloaded from 8MerchánBaezaJA, etal. BMJ Open 2020;10:e037542. doi:10.1136/bmjopen-2020-037542 Open access disassembled into three parts, with the container upside down; (3) the toaster will be unplugged, with the cable handing from the edge of the table and (4) the butter knife will be inside the jam jar. Figure 1 shows the details of the objects and their characteristics. In the dressing task, the participants will be presented with a basket with different pieces of clothing in it (see figure 1). Next, they will be asked to dress the upper part of their trunk as if they were preparing to go out and imagining it were raining, thus they will have to take the shirt and the oilskin jacket from among the different pieces of clothing. Moreover, they will also find five distracting objects inside the basket: a complete set of pyjamas, a robe, two socks and a clothespin, which they are not supposed to use. As in the breakfast task, four different conflicting situations were designed for the dressing task: (1) the shirt will be presented inside out, (2) with the clothespin attached between the first and second button, (3) the oilskin jacket will be presented inside out and (4) with one of the socks sticking out of the pocket. To begin the evaluation, the participant will be asked to name all the objects, foods and pieces of clothing presented on the table and in the basket. If the participant omits one of them, this will be pointed out and named for the participant. Then, he/she will be given the following task instructions (breakfast task): ‘I am going to ask you to make a juice with these oranges (for which you will need to cut them first), with a teaspoon of sugar and a toast with butter and jam, as if you were really going to have them, even if you do not right now. If you need motor help, tell me what you need specifically, and I will help you’. For the dressing task, these will be the instructions: ‘Imagine that it is raining right now Evaluated function Awareness ADL protocol proposed: ecological tools and variables used in the analysis Traditional tests and variables used in the analysis Selfevaluation Awareness questionnaire 1. Discrepancy index calculated from the participant’s selfappraisal score in the postperformance Likert scale minus the actual performance. (Min: −4Max:4) Auditory verbal learning test 1. Shortterm: Total no of words recalled in the short term in the five trials. (Min 0Max 75). Updating procceses Awareness questionnaire 1. Discrepancy index calculated from the score of the Likert scale at 25–30 min after minus the participant’s selfappraisal score in the postperformance Likert scale (0–4). (Min: −4Max:4) Auditory verbal learning test 1. Long term: No of words remembered after 20 min. (Min 0Max 15). ADL, activities of daily living; BADL, basic ADL; IADL, instrumental ADL. Table 1 Continued Figure 1 Possible presentation of the different objects in each of the awareness ADL: Orange juice with butter and jam and upper dress task. ADL, activities of daily living. 750. Protected by copyright. on November 26, 2020 at Granada/Medicina/CC Salud PO Boxhttp://bmjopen.bmj.com/BMJ Open: first published as 10.1136/bmjopen-2020-037542 on 26 October 2020. Downloaded from 9 MerchánBaezaJA, etal. BMJ Open 2020;10:e037542. doi:10.1136/bmjopen-2020-037542 Open access and we are going to go outside. Please, get the upper part of your body dressed and get ready to go outside in the most appropriately way possible. The task will end when you open the door to go out’. Then, the participant will be asked to answer the anticipatory awareness question, explained in the next section: ‘Could you repeat what I asked you to do?’ If the participant does not repeat all the tasks requested, he/she will be asked again until the participant describes the entire process. Lastly, the participant will be asked: ‘Please, do everything you need to do to carry out the task I asked you to perform. If you need my help you can ask me, although I will not remind you what you have to do while you do the task. Remember that you have to do it as if you were really going to eat it, although you do not have to eat it. Please, let me know when you are done’. Two variables will be included in the analysis of this measure: detected errors and corrected errors. The types of errors that can be made, which will be coded in this study, are shown in table 1. To evaluate emergent awareness, we will calculate the total of errors made by the patient, both spontaneous mistakes and those caused by conflicting situations and the presence of distracting objects. The detected errors category will be calculated as a percentage, dividing the total errors detected by the total errors made. Table 1 shows a description of how these errors will be coded as detected. The selfregulation processes will be calculated also as percentages, dividing the number of detected errors and conflicting situations by those corrected and anticipated by the participant. To measure anticipatory awareness in ADL performance, after describing each ADL task and before its performance, the evaluator will ask the participants to rate how well they think they will perform (ie, to predict the number of errors) in a Likert scale (0–4), where 0=‘I won’t be able to do it’; 1=‘I can do it, but I will make many mistakes’; 2=‘I can do it, but I will make some mistakes’; 3=‘I will do it quite well, with few errors’; 4=‘I will do it perfectly without making any mistakes’. This estimate will be compared with the actual performance of the activity. In order to compare it with the participant’s prediction, the objective performance will be measured on a Likert scale (0–4: 0=‘can’t do the task’; 1=‘many errors’; 2=‘some errors’; 3=‘few error’; 4=‘no errors’). The transformation of the absolute number of errors made during the task to a Likert scale will be done by calculating the z score, based on the entire sample, for the total number of errors for each participant and assigning to each range of z score a score of the Likert scale (ie, Z ≤0.5=4 ‘no errors’; −0.5<Z <0=3 ‘few errors’; 0<Z <0.5=2 ‘some errors’; Z>0.5=1 ‘many errors’; if the participant can’t complete the task=0 ‘can’t do the task’). A discrepancy index between the scores of the two Likert scales (prediction minus actual performance) will be calculated to obtain a measure of anticipatory awareness in an ordinal scale ranging from 4 (maximum anticipatory overestimation) to −4 (maximum anticipatory underestimation).To measure selfevaluation, the same Likert scale administered before the task will be administered at the end of the task, although, in this case, the participants will be asked to evaluate the amount of errors made during the task immediately after its completion. The items of this postevaluation Likert scale will be 0=‘I couldn’t do it’; 1=‘I could do it, but I made many mistakes’; 2=‘I could do it, but I made some mistakes’; 3=‘I did it quite well, with few errors’; 4=‘I did it perfectly without making any mistakes’. The selfevaluation index will be calculated as the discrepancy between the participant’s selfappraisal score in the postperformance Likert scale minus the actual performance Likertscale score, obtaining an ordinal scale, where 4 is the maximum selfevaluation overestimation and −4 the maximum selfevaluation underestimation. Right after completing the selfevaluation Likert scale, we included qualitative questions about the types of mistakes made, difficulties encountered and strategies used to solve them. Lastly, to measure the updating process, 25–30 min after completing every ADL, the patients will answer the same postperformance Likert scale and a discrepancy index will be calculated as the score obtained at 25–30 min after the end of the task minus the score obtained immediately after each task. Table 1 shows the variables gathered in this protocol. Evaluation of other classical measures of awareness previously studied Metacognitive evaluation (offline): PCRS.1 The primary purpose of the PCRS is to evaluate selfawareness (the ability to appraise one’s current strengths and weaknesses) following TBI. The PCRS is a 30item selfreport instrument that asks the person with brain injury to rate his or her degree of difficulty to accomplish common daily activities in the domains of ADL (eight items), cognitive function (eight items), interpersonal function (seven items) and emotional function (seven items) on a 5point Likert scale (1=cannot do it; 2=it is very difficult to do; 3=I can do it with some difficulty; 4=it is fairly easy to do; 5=I can do it easily). The subject’s responses are compared with those of a significant person (relative, caregiver or therapist), who rates the subject on the identical items. For the present study, this will be a direct family member or caregiver in every case. Impaired selfawareness may be inferred from discrepancies between the two ratings, that is, when the subject overestimates or underestimates his/her abilities compared with the other informant. A discrepancy index of >5 determines the presence of anosognosia in the patient. This scale has shown excellent correlation in two tests for patients with TBI (r=0.97) and relatives (r=0.92), excellent test–retest reliability (intraclass correlation coefficient (ICC)=0.85) and excellent interrater ratings (r=0.92). In addition to finding the discrepancy index with this measure, the family member’s PCRS will also be used as a measure of functional criteria of each participant, as has been used in a previous study.53 750. Protected by copyright. on November 26, 2020 at Granada/Medicina/CC Salud PO Boxhttp://bmjopen.bmj.com/BMJ Open: first published as 10.1136/bmjopen-2020-037542 on 26 October 2020. Downloaded from