National Institute of Mental Health Life Chart Method – Self/Prospective (NIMH-LCM-S/P™): translation and adaptation to Brazilian Portuguese

Abstract Objective The objective of this study was to translate and adapt the National Institute of Mental Health Life Chart Method – Self/Prospective (NIMH-LCM-S/P™) instrument for self-monitoring of mood into Brazilian Portuguese and provide evidence of content validity. Additionally, a user guide was prepared for the instrument and evaluated by mental health professionals. Methods The study was divided into two stages – Stage 1: Translation and cross-cultural adaptation and Stage 2: Determination of content validity index (CVI) scores. The translation and cross-cultural adaptation process involved 37 participants between translators, experts, target population, and evaluators. Results The CVI was evaluated by 15 mental health professionals. 11 (78.57%) of the items evaluated attained the maximum CVI score of 1.00, which constitutes the highest level of content validity, and no changes were suggested by participants. Only one of the items evaluated had a CVI score lower than 0.80. Conclusion The final translated and adapted version of the NIMH-LCM-S/P™ and its user guide were evaluated by the target population and the mental health professionals. Both groups displayed satisfactory comprehension levels, suggesting there is potential for using this instrument in clinical practice to assess therapeutic interventions in Brazilian settings.


Introduction
Mood disorders are significant and persistent mood alterations that can affect the individual's global functioning. These disorders manifest through symptoms of depression (with or without associated anxiety) or symptoms of mania/hypomania (enhanced energy levels). 1 The global prevalence of mood disorders is 9.6%, with women being more susceptible (4% vs. 7.3%). 2 It is estimated that the prevalence of depression in Brazil is 5.8% among the general population. 3 Preliminary diagnosis of mood disorders can be complex and difficult to make for many healthcare professionals. 1  Another way to assess changes in mood is through tracking and monitoring of said changes, which allows patients and practitioners to detect alterations and evaluate treatment effectiveness. Furthermore, this approach makes it possible to estimate future episodes of illness and prevent relapses. [7][8][9] Mood can be monitored and tracked using graphs, such as life charts (a tracking method used to register the patient's mood daily, based on their daily symptoms). Life charts make it possible to visualize mood changes along a longitudinal timeline. 9,10 Mood monitoring based on observational research was first described by Kraepelin in 1921. 11 Kraepelin sought to systematically and thoroughly depict his practice by recording the severity, the duration, and the characteristics of manic and depressive episodes for each patient. Over the years, researchers developed other methods to systematically assess changes in mood, such as the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD), 12 the ChronoSheet, 13 14,18 The information is charted by the patient, which allows better control of symptoms from mood disorders and faster interventions, as well as long-term recording of illness management. It can also benefit therapeutic relationships. Patients that have used the LCM™ showed an increase in euthymic periods and a decrease in the deficit (subsyndromal) of depressive and manic and hypomanic days. 19 The LCM™ is still commonly used in clinical trials and scientific research because it assesses mood in a simple, practical, and detailed manner. [20][21][22] The LCM™ instrument presented external validity when compared to other classic instruments of mood monitoring, such as the Inventory of Depressive Symptomatology-clinician-rated (IDS-C) (r = -0.718; p < 0.001), and the YMRS (r = 0.491; p = 0.001). 20 The instrument has been also translated and adapted into German. 23 No studies were found that administered the LCM™ in Brazil, despite the retrospective model in its clinical version (NIMH-LCM-R/C™) already having been translated and adapted to Brazilian Portuguese by Brietzke, Daruy Filho, and Grassi-Oliveira. 15 Only a few Brazilian studies that used graphical and systematic mood monitoring were found in the literature. 24,25 These studies mostly used mood monitoring only as a complement to assess intervention efficacy in patients with mood disorders. Moreover, they used graphs freely, with no reference, criteria, or clear and defined standards.
Mood monitoring is a comprehensive method involving large quantities of information. It is recommended that practitioners use standardized tools so that they can describe how the tools were used, the reasons for using them, and how data was analyzed. 21

Methods
In this study, a combination of methods were adopted for translation and cross-cultural adaptation of the NIMH-LCM-S/P™. These methods were suggested by Borsa et al. 26 Cassepp-Borges et al., 27 Gjersing et al., 28 Hungerbünler & Wang, 29 and Paiano et al. 30 According    26 Cassepp-Borges et al., 27 Gjersing et al., 28 Hungerbünler & Wang, 29  The back-translations were sent for evaluation to a Canadian professor who is a native English speaker and mental health professional, thus ensuring the validity of the translation.

Stage 2 -Content validity index (CVI)
After the adjustments suggested during the back translation step had been made, the final version in Brazilian Portuguese was used to determine the CVI scores. Items were assessed for suitability using closed-ended questions ("yes" or "no"). A space for comments was also included for each item evaluated, because closed-ended questions can be limiting.
Evaluators could thus comment on further aspects, reducing the likelihood of biases during the approval process by expert evaluators. 31 Data were collected through an online platform called Qualtrics Survey Software.
After that, the answers were used to calculate the CVI for each item with the formula CVI = (ne -N/2)/ (N/2) (where, ne = the number of evaluators that rated an item as essential; and N = the total number of evaluators). 32 This formula is widely used for analyses such as this. 33,34 Participants in the CVI stage The CVI evaluation was performed by 15 mental health professionals -psychiatrists as well as psychologists. The number of evaluators was higher than what is recommended in the literature, which is 2 to 10 evaluators. 35 Eleven (73.30%) were women; ten (66.67%) had a degree in Psychology, and five (33.33%) had a medical degree and residency in psychiatry. Their mean experience in the area was 10.93 years (SD = 6.60 years), with a range of 2 to 28 years of experience.
Volunteers were recruited using an electronic form, which was completed by the volunteers themselves.

Form with evaluators' (experts) information
This covered the following variables: age, gender, education (undergraduate, specialization, master's degree, or doctorate), and years spent in education.

National Institute of Mental Health Life Chart Method -
Self/Prospective (NIMH-LCM-S/P™) 14,18 Instrument created by the NIMH. This instrument is used by patients to monitor mood daily and prospectively.
The course of illness can be rated at one of four levels

Data analysis procedures
Data were analyzed and organized in a database, which was created using the Statistical Package for the Social Sciences (SPSS) version 23 for Windows. Data were described as absolute and relative frequencies for qualitative variables and mean and standard deviation for quantitative variables.

Ethical procedures
This study meets all the guidelines and regulatory

Translation and cross-cultural adaptation
The translation and cross-cultural adaptation process  Figure S1, available as online-only supplementary material.

Content validity index (CVI)
The CVI scores resulting from the professional analysis are shown in Table 2. It can be observed that all evaluated items obtained a CVI above the cutoff suggested by Hutz et al. 34 for 15 evaluators. The minimum CVI suggested was 0.49. Table 1 -The main suggestions, alterations, and procedures adopted during the process of translation and cross-cultural adaptation of the NIMH-LCM-S/PTM

Items Phase Suggestions Alterations
General structure of the instrument Evaluation by the target population Distribution of items on additional sheets of paper, more space for notes The original instrument was reorganized to use two pages. The life events and impact items and the list of comorbid symptoms were moved to a second page of the instrument. Font size, font type and graphs were also altered to optimize space for notes. The NIMH-LCM-S/P™ method was preserved.

Dotted lines Evaluation by the target population
Substitution of the dotted lines in the mood severity note section for something more intuitive and easier to understand. Suggestion: circles that can be colored-in.
Suggestions were taken into consideration. The dotted lines were substituted by circles that can be colored-in.

Instructions
Evaluation by the target population and during the evaluation by professionals Creation of a guide for patients and summarized instructions of the instrument.
Suggestions were taken into consideration. A user guide for using the instrument was created, and the summarized instructions were integrated into the instrument.   the instructions in the user guide. It was also suggested that the word "intensity" be changed to "severity" in item 3 of the instrument.

Discussion
The One of the objectives of a rigorous translation and crosscultural adaptation process is to guarantee equivalence regardless of the context in which the instrument is used. 26,40 Borsa et al. 26 stress that instruments must be evaluated by the target population to verify item suitability throughout the cross-cultural adaptation process. These authors also emphasize that this evaluation must be done one or more times if necessary.
In this study, two evaluations by the target population were needed because of initial difficulties understanding the instrument. The suggestions provided were used to alter the instrument in order to make it more understandable and suitable for the target population. interventions longitudinally, which will help patients, health professionals, and researchers to assess and better comprehend mood symptoms. 20 It is possible, through self-monitoring, to become acquainted with mood changes to estimate future episodes of illness, response to medication, and increase in euthymic periods, as well as prevention of relapse. [7][8][9] It is also possible to assess the number, sequence, intensity, and duration of each episode, among other items that can influence mood (hours of sleep, medication, menstrual cycle, life events). 9,10 The final version of the translation and adaptation of the NIMH-LCM-S/P™ and its user guide were evaluated by the target population and mental health professionals. Both groups displayed satisfactory comprehension levels, which suggest the potential for using this instrument in clinical practice to assess therapeutic interventions in Brazilian settings. However, this study has only initiated the process of instrument evaluation. It is necessary to obtain other types of evidence of validity, such as convergent validity, by observing correlations between this instrument and other instruments that are already traditional in mood assessment. Future studies are also recommended to adapt this method to the Brazilian context in virtual environments, as already done in other countries. [41][42][43] Regardless, this is an instrument that is accessible and in the public domain. It helps patients in their self-monitoring of mood using graphs and longitudinal tracking, which enables patients and practitioners to monitor patient evolution and treatment.