Validation of the WHOQOL-Bref instrument in Brazilian sign language (Libras).

PURPOSE: The recognition of the Brazilian Sign Language (Libras) as the official language of the Brazilian deaf, in 2002, reaffirms the linguistic and cultural particularities of the deaf population. Therefore, there is a lack of a validated instrument for assessing the Quality of Life of deaf people using Libras. With authorization from the World Health Organization (WHO), a version of the WHOQOL-Bref in Libras was developed, called WHOQOL-Bref/Libras. However, its psychometric properties have not been examined as yet. Therefore, the purpose of this work is to perform the psychometric validation of the WHOQOL-Bref/Libras. METHODS: WHOQOL-Bref/Libras and a sociodemographic questionnaire were applied to 311 deaf people from the five Brazilian regions. To assess temporal stability, the questionnaire was readministered to 52 deaf people, over an interval of 2 weeks. RESULTS: WHOQOL-Bref/Libras demonstrated satisfactory psychometric values for reliability, discriminant and construct validity, temporal stability, and internal consistency. Cronbach's alpha coefficient showed satisfactory values for each of the WHOQOL-Bref domains: Physical health (0.641), Psychological (0.705), Environment (0.710), and Overall-Bref domains (0.873). The WHOQOL-Bref/Libras is the appropriate option to assess the quality of life of deaf people who communicate through Libras. CONCLUSION: WHOQOL-Bref/Libras had a satisfactory psychometric performance; therefore, it is a valid option that will provide autonomous participation for the deaf in quality of life investigations.

Differential biomarker signatures in unipolar and bipolar depression: A machine learning approach.

OBJECTIVE: This study used machine learning techniques combined with peripheral biomarker measurements to build signatures to help differentiating (1) patients with bipolar depression from patients with unipolar depression, and (2) patients with bipolar depression or unipolar depression from healthy controls. METHODS: We assessed serum levels of interleukin-2, interleukin-4, interleukin-6, interleukin-10, tumor necrosis factor-α, interferon-γ, interleukin-17A, brain-derived neurotrophic factor, lipid peroxidation and oxidative protein damage in 54 outpatients with bipolar depression, 54 outpatients with unipolar depression and 54 healthy controls, matched by sex and age. Depressive symptoms were assessed using the Hamilton Depression Rating Scale. Variable selection was performed with recursive feature elimination with a linear support vector machine kernel, and the leave-one-out cross-validation method was used to test and validate our model. RESULTS: Bipolar vs unipolar depression classification achieved an area under the receiver operating characteristics (ROC) curve (AUC) of 0.69, with 0.62 sensitivity and 0.66 specificity using three selected biomarkers (interleukin-4, thiobarbituric acid reactive substances and interleukin-10). For the comparison of bipolar depression vs healthy controls, the model retained five variables (interleukin-6, interleukin-4, thiobarbituric acid reactive substances, carbonyl and interleukin-17A), with an AUC of 0.70, 0.62 sensitivity and 0.7 specificity. Finally, unipolar depression vs healthy controls comparison retained seven variables (interleukin-6, Carbonyl, brain-derived neurotrophic factor, interleukin-10, interleukin-17A, interleukin-4 and tumor necrosis factor-α), with an AUC of 0.74, a sensitivity of 0.68 and 0.70 specificity. CONCLUSION: Our findings show the potential of machine learning models to aid in clinical practice, leading to more objective assessment. Future studies will examine the possibility of combining peripheral blood biomarker data with other biological data to develop more accurate signatures.

Can Religious Coping and Depressive Symptoms Predict Clinical Outcome and Quality of Life in Panic Disorder? A Brazilian Longitudinal Study.

Few studies have investigated the relationship between spiritual/religious coping (S/R coping) and panic disorder (PD). This Brazilian longitudinal study evaluated if S/R coping and depressive symptoms can predict PD remission and improved quality of life (QoL). There were 101 outpatients with PD who were followed up for 12 to 16 weeks. The prevalence ratio (PR) between positive S/R coping and negative S/R coping and PD remission was assessed, as well as the association between positive S/R coping and negative S/R coping and QoL. After adjusting for confounding factors, positive S/R coping presented an inverse PR with PD remission, which was not statistically significant (0.88; p = 0.075). There was no association between S/R coping and QoL. Depressive symptoms were negatively associated with PD remission (PR = 0.97; p < 0.01) and were not predictive of a better QoL.

Illness severity and biomarkers in depression: Using a unidimensional rating scale to examine BDNF.

BACKGROUND: Numerous studies have reported reduced peripheral brain-derived neurotrophic factor (BDNF) in major depression (MD). However, most of these studies used multidimensional depression rating scales, and failed to identify a relationship between BDNF levels and depression severity. Unidimensional scales are a more valid measure of syndrome severity. In these scales, items are ordered in increasing severity, so that as scores increase, syndrome severity increases; thus, each item adds unique information, and items can be totaled to a meaningful sum. The current study used the HAM-D6, a unidimensional measure of depression, to examine if it could identify a correlation between serum BDNF and depression severity. METHODS: Serum BDNF levels and symptom severity were assessed in 163 depressed patients, including those with both unipolar (84.0%) and bipolar (16.0%) depression. The evaluation of depression severity included the total HAM-D17 and 3 subscales, including the HAM-D6. RESULTS: On average, patients presented moderate to severe depression (HAM-D17=21.2±5.5). Overall BDNF levels were 60.4±22.6ng/mL. The correlation between serum BDNF and depression severity was modest and not different when assessed by the HAM-D6 subscale or the HAM-D17 as a whole (z=0.951; p=0.341), despite being statistically significant for the HAM-D6 (r=-0.185; p=0.019; 95% CI: -0.335 to -0.033), but not for the entire HAM-D17 (r=-0.127; p=0.108; 95% CI: -0.272 to 0.027). CONCLUSION: We could not identify a strong relationship between serum BDNF levels and depression severity using the HAM-D6. This is in concordance with results of previous studies that reported no correlation between these variables, and indicates that the properties of the clinical measures used cannot explain the results these studies.

Quality-of-life and spirituality.

Spirituality has been identified as an important dimension of quality-of-life. The objective of this study was to review the literature on quality-of-life and spirituality, their association, and assessment tools. A search was conducted of the keyterms 'quality-of-life' and 'spirituality' in abstract or title in the databases PsycINFO and PubMed/Medline between 1979-2005, complemented by a new search at PUBMED from 2006-2016. Quality-of-life is a new concept, which encompasses and transcends the concept of health, being composed of multiple domains: physical, psychological, environmental, among others. The missing measure in health has been defined as the individual's perception of their position in life in the context of culture and value system in which they live and in relation to their goals, expectations, standards, and concerns. There is consistent evidence of an association between quality-of-life and religiosity/spirituality (R/S), through studies with reasonable methodological rigour, using several variables to assess R/S (e.g. religious affiliation, religious coping, and prayer/spirituality). There are also several valid and reliable instruments to evaluate quality-of-life and spirituality. Further studies are needed, however, especially in Brazil. Such studies will provide empirical data to be used in planning health interventions based on spirituality, seeking a better quality-of-life. In the last 10 years, research is consistently growing about quality-of-life and spirituality in many countries, and also in many areas of health research.

A naturalistic study of high-dose unilateral ECT among severely depressed inpatients: how does it work in the clinical practice?

BACKGROUND: Naturalistic studies can be useful tools to understand how an intervention works in the real clinical practice. This study aims to investigate the outcomes in a naturalistically treated depressed inpatients cohort, who were referred, or not, to unilateral ECT. METHODS: Depressed adults according to MINI admitted in a psychiatric unit were divided in unilateral ECT treated and non-ECT treated. Main outcomes were: depression improvement in Hamilton Rating Scale for Depression (HDRS-17) scores; response (HDRS-17 improvement ≥50 %); remission (HDRS-17 score ≤7); length of hospitalization. RESULTS: Forty-three patients were included in unilateral ECT group and 104 in non-ECT group. No differences of psychotic symptoms, melancholic features or past maniac episode were found between groups. Unilateral ECT group had a mean HDRS-17 score higher than non-ECT group at admission (ECT: 25.05 ± 1.03; non-ECT: 21.61 ± 0.69; p = 0.001), but no significant difference was found at discharge (ECT: 7.70 ± 0.81; non-ECT: 7.40 ± 0.51; p = 0.75). Unilateral ECT group had a larger HDRS-17 score reduction during treatment (ECT: 18.24 ± 1.18; non-ECT:14.20 ± 0.76; p = 0.004). There were no significant differences in response and remission rates between groups. Unilateral ECT group had longer mean duration of hospitalization in days (ECT: 35.48 ± 2.48; non-ECT: 24.57 ± 1.50; p < 0.001), but there were no difference in mean time of treatment (ECT group:27.66 ± 1.95; non-ECT: 24.57 ± 1.50; p = 0.25). CONCLUSIONS: Unilateral high-dose ECT is still a useful treatment option, in the real world clinical practice, to reduce the intensity of depressive symptoms in highly depressed inpatients.

The World Health Organization Quality of Life instrument for people with intellectual and physical disabilities (WHOQOL-Dis): evidence of validity of the Brazilian version.

BACKGROUND: The number of people with disabilities in Brazil and worldwide has grown substantially in recent decades. Cross-cultural quality of life instruments can be helpful in the development of interventions designed to meet the needs of this population and contribute to rational allocation of resources. This study sought to provide evidence of validity and reliability the Brazilian Portuguese version of WHOQOL-Dis-D (a cross-cultural, multicentre instrument developed by the WHOQOL-Group for the assessment of quality of life in persons with physical disability - PD) and WHOQOL-Dis-ID (for persons with intellectual disability - ID). METHODS: Classical psychometric methods were used to conduct independent analyses of the PD and ID samples. Criterion groups were established for analysis of construct validity. Concurrent validity was assessed in relation to SWLS and BDI-II scores; discriminant validity, in relation to WHODAS-II. Cronbach alpha was used to test the instrument scales and subscales for reliability. The ID subgroup was retested, and test-retest reliability assessed by means of intraclass correlation coefficients and paired Student's t-test. RESULTS: A total of 162 (98 females) people with PD and 156 (55 females) people with ID participated in the study. Cronbach alpha was satisfactory across practically all domains and factors in the PD subsample. In IDs, most factors or domains had coefficients higher than 0.70, but four subscales exhibited less satisfactory performance. Evidence of construct and concurrent validity and reliability were obtained. CONCLUSIONS: The analyses presented herein provide satisfactory evidence of the validity and reliability of the instrument and corroborated the factor structure revealed during cross-cultural research. Further studies with larger sample sizes are required to obtain additional evidence of validity and reliability.

Depression as a major impact on the quality of life of HIV-positive Brazilians.

Given that mental symptoms might interfere with the quality of life (QOL) of people living with HIV/AIDS (PLHAs), the goal of this paper was to examine the correlation between depression, anxiety, and QOL in a sample of HIV-positive Brazilians. A cross-sectional study was designed to analyze the correlations between the presence of mental symptoms and the QOL scores of PLHAs. Depression and anxiety symptoms were measured using the Beck Depression Inventory and the State-Trait Anxiety Inventory, respectively. The QOL was assessed using the World Health Organization Quality of Life instrument - HIV module. A convenience sample of 308 men and women living with HIV (131 asymptomatic, 91 symptomatic, and 86 with AIDS) in Porto Alegre/RS-Brazil was selected. The depression scores were higher in patients with AIDS compared with asymptomatic and symptomatic patients, yet there were no differences in the anxiety scores between the stages of infection. Better QOL scores were observed in the earlier stages of infection (asymptomatic and symptomatic groups). In the correlation between mental symptoms and QOL scores, the Pearson's coefficient values were of a moderate (r = .47) to a large (r = .65) magnitude for depressive symptoms, and the scores for the anxiety symptoms were small to moderate (r ≤ .35). After adjusting for the disease stage and clinical and sociodemographic variables in a multiple regression model (using QOL as the dependent variable), the depressive symptoms showed significantly higher beta-coefficient values compared with the remaining variables. The data obtained from this study indicate that the QOL of PLHAs is primarily affected by depression. Thus, it has been strongly recommended that treatment programs dedicated to PLHAs assess depressive symptoms, providing subsequent referrals and treatments. Treating depression might be effective for PLHAs and might potentially improve both the overall QOL and the health outcomes.

Clinical differences between melancholic and nonmelancholic depression as defined by the CORE system.

BACKGROUND: The definition and delineation of melancholia have remained elusive for an extended period. A longstanding signal of psychomotor disturbance has been operationalized via the observer-rated CORE measure and with CORE-assigned melancholic and nonmelancholic compared in several Australian studies. Replication studies in other regions have not previously been reported. This study compares Brazilian patients with melancholic and nonmelancholic depression according to the CORE measure of psychomotor disturbance in terms of clinical characteristics, suicide ideation, stressful life events, quality of life, parental care, and personality styles. METHODS: A total of 181 patients with unipolar major depression attending a tertiary care outpatient service in Brazil were evaluated in relation to melancholic status and study variables. RESULTS: The CORE-assigned melancholic patients presented higher symptom severity, greater prevalence of suicide ideation, and Axis I comorbidities than nonmelancholics. Scores of dysfunctional personality styles and dysfunctional parental care measures were also higher among melancholics. Quality-of-life scores were low in both groups. LIMITATIONS: The absence of a criterion standard for the diagnosis of melancholia and the use of medication can be potential limitations of the study. CONCLUSION: Differences suggest that CORE-assigned melancholia defines a distinct group of patients and probably a disorder distinct from nonmelancholic depression not only in quantitative but also in qualitative aspects.

Prevalence of psychotic symptoms in those with melancholic and nonmelancholic depression.

The best classification of depressive disorders is still to be established. A melancholic subtype has a lengthy history, and recent research demonstrates its relevance. This study compares the prevalence of psychotic symptoms in nonmelancholic and melancholic depression and assesses whether there is a dimensional pattern in the severity of symptoms among the subtypes. Patients with unipolar depression were assessed for melancholic status, psychotic symptoms, and severity of depression. The diagnosis of melancholia was made by both Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR), criteria and CORE measure. The DSM criteria assigned a much higher percentage of patients as melancholics (67.4%) than did the CORE (24.9%). Prevalence of psychosis was distinctly higher in the melancholics. Symptoms severity was higher among the melancholics when compared with the nonmelancholics. The presence of psychotic symptoms was not associated with an increase in the intensity of depressive symptoms. Psychotic symptoms are more frequently associated with the melancholic subtype of depression. This suggests clinical contiguity between the melancholic and psychotic subtypes and the clinical relevance of identifying melancholia.

Chronic pain predicts a worse response to depression treatment, regardless of thyroid function or psychotropics prescribed.

BACKGROUND: Chronic pain (CP) and thyroid hormones' (TH) abnormalities are associated with depression, but the impact of pain and TH fluctuation on the response to depression treatment is uncertain. METHODS: Eighty-eight patients with major depression were evaluated before and after 6 months of specific treatment, through scales of symptoms' severity (HAM-D-17), psychomotor disturbance (CORE), and quality of life (WHOQOL-Bref). We reviewed psychiatric medications and measured TSH, T3 and T4. We used Generalized Estimating Equations to assess the interaction effect between CP and treatment time on depression severity and TH levels, and Bonferroni to compare means. RESULTS: 47.7 % of the patients had CP. Patients with and without CP did not differ at baseline. At follow-up, those with CP experienced a more modest decrease in symptoms' severity and no improvement in any domain of psychomotor disturbance, contrasting with a decrease of over 40 % from the baseline values of CORE in patients without CP (non-CP). Initial and final scores were respectively: HAM-D CP 24.06 and 19.3, Δ = -4.75; HAM-D non-CP 22.92 and 14.7, Δ = -8.21; CORE CP 5.36 and 5.24, Δ = -0.12; CORE non-CP 5.8 and 3.22, Δ = -2.57. There was no interaction with TH or life quality. Model adjustments for psychotropic drugs received and sensitivity analysis excluding somatic symptoms from severity scales did not impact the results. LIMITATIONS: Findings may not replicate in mildly depressed patients from primary care. Pain scales were not applied. CONCLUSIONS: Individuals with chronic pain showed a suboptimal response to depression treatment, regardless of the medications used or TH levels.

The EUROHIS-QOL 8-item index: comparative psychometric properties to its parent WHOQOL-BREF.

OBJECTIVES: To test the psychometric properties of the EUROHIS-QOL 8-item index, a shortened version of the World Health Organization Quality of Life Instrument-Abbreviated Version (WHOQOL-BREF). METHODS: The sample consisted of 2359 subjects identified from primary care settings, with 1193 having a confirmed diagnosis of depression. Data came from six countries (Australia, Brazil, Israel, Russia, Spain, and the United States) involved in a large international study, the Longitudinal Investigation of Depression Outcomes. The structure of the EUROHIS-QOL 8-item index follows that of the WHOQOL-BREF assessment. Internal consistency was measured by using Cronbach's alpha. Convergent validity was assessed by using correlations with different measures for mental health (Symptom Checklist 90), physical health (self-evaluation), and quality of life (WHOQOL-BREF and short form 36 health survey). Discriminant group validity was assessed between diagnosed depressed and nondepressed patients. Differential item functioning and unidimensionality were analyzed by using Rasch analysis. Factor structure was assessed with structural equation modeling analyses. RESULTS: Internal consistency was acceptable (ranged between 0.72 and 0.81 across countries), and the index discriminated well between depression (t = 6.31-20.33; P < 0.001) across all countries. Correlations between the EUROHIS-QOL 8-item index and different measures--Symptom Checklist 90 (r = -0.42), physical health (r = -0.42), WHOQOL-BREF domains (r = 0.61-0.77), and short form 36 health survey (r = 0.58)--were all significant (P < 0.001). The index is unidimensional with desired item fit statistics. Two items ("daily living activities" and "enough money to meet your needs") had residuals exceeding 4. Differential item functioning was observed with general quality of life, general health, relationships, and home items for age. A common one-factor structure with acceptable fit was identified in three out of six countries (comparative fit index = 0.85, root mean square error of approximation = 0.11). CONCLUSIONS: The EUROHIS-QOL 8-item index showed acceptable cross-cultural performance and a satisfactory discriminant validity and would be a useful measure to include in studies to assess treatment effectiveness.

Quality of care, quality of life, and attitudes toward disabilities: perspectives from a qualitative focus group study in Porto Alegre, Brazil.

OBJECTIVE: To explore the concepts of quality of life (QOL), quality of care (QOC), and attitudes toward disabilities in Porto Alegre, Brazil, from the perspective of people living with disabilities, including their relatives and caregivers. METHODS: This was a qualitative study that interviewed a total of 23 participants in five focus groups, during May-August 2006. After an open discussion about QOL, the WHOQOL-Bref, a generic questionnaire for the assessment of QOL, was presented to participants. The study was performed simultaneously in 15 international centers. Analysis was based on Bardin's content analysis. RESULTS: Regarding QOL, important themes that emerged were: work, education, leisure, universal accessibility, integration in the society, and social inclusion. Concerning QOC, professional qualifications, disabilities-related training for health and education professionals, and access to health services were considered important. Regarding attitudes toward disabilities, the participants perceived the attitudes of others, especially of caregivers, to significantly impact the QOL of people with disabilities. CONCLUSIONS: People living with disabilities value many of the same themes considered important by the general public; however, several additional themes specific to disabilities and specific to these groups of participants emerged. This information highlights the importance of taking into account the unique perceptions and cultural traits of the target population when measuring QOL, QOC, and attitudes toward disabilities.

Estimating the SF-6D value set for a population-based sample of Brazilians.

OBJECTIVES: SF-6D is a preference-based measure of health developed to estimate utility values from the SF-36. The aim of this study was to estimate a weighting system for the SF-6D health states representing the preferences of a sample of the Southern Brazilian general population. METHODS: A sample of 248 health states defined by the SF-6D was valued by a sample of the southern Brazilian population using the standard gamble. Mean and individual level multivariate regression models were fitted to the standard gamble valuation data to estimate preference weights for all SF-6D health states. The models were compared with those estimated in the UK study. RESULTS: Five hundred twenty-eight participants were interviewed, but 58 (11%) were excluded for failing to value the worst state. Data from 469 subjects producing 2696 health states valuations were used in the regression analysis. In contrast to the best performing model for the UK data, the best performing model for the Brazilian data was a random effects model using only the main effects variables, highlighting the importance of adopting a country-specific algorithm to derive SF-6D health states values. Inconsistent coefficients were merged to produce the final recommended model, which has all significant coefficients and a mean absolute difference between observed and predicted standard gamble values of 0.07. CONCLUSIONS: The results provide the first population-based value set for Brazil for SF-6D health states, making it possible to generate quality-adjusted life years for cost-utility studies using regional data. Besides, utility weights derived using the preferences of a sample from a southern Brazilian population can be derived from existing SF-36 data sets.

Quality of life in Brazil: normative values for the WHOQOL-bref in a southern general population sample.

PURPOSE: Normative data for WHOQOL-bref are scarce in the literature and unavailable in Latin American countries. The main objective of this study was to provide normative scores of WHOQOL-bref in a general population sample in Brazil and to describe differences in mean scores according to some socio-demographic characteristics. METHODS: WHOQOL-bref was applied to a randomly selected sample of the general population of Porto Alegre. Participants were literate people aged 20 to 64 years. The questionnaires were self-administered in the presence of an interviewer in the respondent's home. RESULTS: The response rate was 68%, and the final sample contained 751 respondents (38% men, 62% women). Low quality of life was observed in the following subgroups: female gender, lower economic class, lower educational level, and the subgroup reporting a chronic medical condition. The mean scores of the WHOQOL-bref and percentiles of scores are reported as normative data for the general population. CONCLUSION: Our results can be useful to researchers using the WHOQOL-bref to compare their results with normative data from a randomly selected sample of general population. Additionally, the ability of WHOQOL-bref to discriminate different population subgroups makes it an important tool to identify vulnerable groups in epidemiological surveys.

Successful electroconvulsive therapy in a drug-refractory depressed patient with idiopathic intracranial hypertension.

The condition of a 42-year-old woman with drug-refractory major depression, severe headache, and progressive visual impairment was diagnosed as idiopathic intracranial hypertension (IICH). Idiopathic intracranial hypertension is a relative contraindication to electroconvulsive therapy (ECT), chiefly due to the theoretical risk of brain herniation. Although the diagnosis of IICH was unequivocal, the patient's headache was interpreted as being unassociated with IICH. Nine ECT sessions were performed, and both depression and headache improved dramatically. People with IICH are at an increased risk of depression and report more physical complains, including headache. Cases of IICH may be considered for ECT if depression is drug-refractory. In this case, cerebrospinal fluid open pressure should be closely monitored.

Evaluation of major depression symptom networks using clinician-rated and patient-rated data.

BACKGROUND: Major depressive disorder (MDD) is heterogeneous, but official diagnostic classifications and widely used rating scales are based on the premise that MDD is a single disorder and that symptoms are equally important to assess severity. Also, patients and clinicians frequently diverge in how they evaluate MDD severity. In order to better understand the differences between MDD scales used by clinicians and patients in the context of MDD heterogeneity, we performed a network analysis from an approach that focuses on the interaction of symptoms rather than total score. METHODS: The Hamilton Depression Rating Scale (HDRS) and the Beck Depression Inventory with 21 items (BDI) scored by the clinician or patient, respectively, were used to estimate the networks based on 794 MDD patients. The networks were estimated using software R 4.0.2 and Graphical Lasso, identifying communities of symptoms by the clique percolation method, and the mixed graphical models were used to evaluate the explained variance of each symptom. RESULTS: The networks presented different communities of symptoms and connection structure (M = 0.177, p = 0.0028). The guilt connection strength and its association with suicidal ideation was greater in the BDI network. LIMITATIONS: Transversal data from severe, chronic, or treatment resistant depression patients. CONCLUSIONS: The present study suggests that the self-rated scale may perform better when assessing association between guilt and other symptoms, especially suicidal ideation. Communities of symptoms and edges between symptoms suggest that insomnia may be an independent symptom, thus requiring specific interventions. Some similar items are strongly connected and could be collapsed.

First-time administration of the Sydney Melancholia Prototype Index (SMPI) to non-English-speaking patients: a study from Brazil.

OBJECTIVE: The Sydney Melancholia Prototype Index (SMPI) is a scale that uses a non-conventional strategy to assess melancholia status based on prototypic symptoms and illness course variables. This study aimed to evaluate the performance of the first translation of this instrument in a non-English-speaking population. METHODS: A sample comprising 106 Brazilian outpatients with depression was evaluated simultaneously with the Brazilian version of the self-rated SMPI (SMPI-SR) and clinician-rated SMPI (SMPI-CR). The kappa coefficient and t test were used to evaluate concurrent validity vs. DSM-IV, CORE system, Hamilton Depression Rating Scale-6 item (HAM-D6), and HAM-D17 assignments to a melancholic or non-melancholic class. The prevalence of melancholia as well as sensitivity and specificity were calculated across instruments. RESULTS: The prevalence of melancholia was highest using DSM-IV criteria (56.6%). The kappa agreement between SMPI-CR and DSM-IV melancholia assignment was moderate (kappa 0.44, p ≤ 0.001). SMPI-CR-assigned melancholic patients had significantly higher CORE, HAM-D17, and HAM-D6 scores. The test-retest consistency values for the SMPI were modest at best, and somewhat superior for the CR version. CONCLUSION: The Brazilian SMPI-CR presented satisfactory psychometric properties (which were superior to those of the SMPI-SR), and therefore appears to be a useful option for identifying melancholia and studying its causes and optimal treatments.

Which outcomes are most important to measure in patients with COVID-19 and how and when should these be measured? Development of an international standard set of outcomes measures for clinical use in patients with COVID-19: a report of the International Consortium for Health Outcomes Measurement (ICHOM) COVID-19 Working Group.

OBJECTIVES: The COVID-19 pandemic has resulted in widespread morbidity and mortality with the consequences expected to be felt for many years. Significant variation exists in the care even of similar patients with COVID-19, including treatment practices within and between institutions. Outcome measures vary among clinical trials on the same therapies. Understanding which therapies are of most value is not possible unless consensus can be reached on which outcomes are most important to measure. Furthermore, consensus on the most important outcomes may enable patients to monitor and track their care, and may help providers to improve the care they offer through quality improvement. To develop a standardised minimum set of outcomes for clinical care, the International Consortium for Health Outcomes Measurement (ICHOM) assembled a working group (WG) of 28 volunteers, including health professionals, patients and patient representatives. DESIGN: A list of outcomes important to patients and professionals was generated from a systematic review of the published literature using the MEDLINE database, from review of outcomes being measured in ongoing clinical trials, from a survey distributed to patients and patient networks, and from previously published ICHOM standard sets in other disease areas. Using an online-modified Delphi process, the WG selected outcomes of greatest importance. RESULTS: The outcomes considered by the WG to be most important were selected and categorised into five domains: (1) functional status and quality of life, (2) mental functioning, (3) social functioning, (4) clinical outcomes and (5) symptoms. The WG identified demographic and clinical variables for use as case-mix risk adjusters. These included baseline demographics, clinical factors and treatment-related factors. CONCLUSION: Implementation of these consensus recommendations could help institutions to monitor, compare and improve the quality and delivery of care to patients with COVID-19. Their consistent definition and collection could also broaden the implementation of more patient-centric clinical outcomes research.