Patient Health Questionnaire-9: A clinimetric analysis.

OBJECTIVE: The Patient Health Questionnaire-9 (PHQ-9) is a widely used self-reported measure of depression, which was found to display only acceptable psychometric properties. Insufficient attention has been devoted to its clinimetric validity and its clinical utility is still debated, particularly when used for assessing depression severity. This is the first study testing PHQ-9 construct validity and clinical utility based on clinimetric principles. METHODS: An online survey involving a sample of 3,398 participants was conducted. Item Response Theory models (Rasch and Mokken analyses) were used to assess PHQ-9 validity and determine its clinical utility. RESULTS: Fit to the Rasch model was achieved after adjusting the sample size. Items 2, 4, 6, 9 displayed over-discrimination, items 1, 5, 7 showed under-discrimination. Indication of local dependency between items 2 and 6 was found. PHQ-9 was not unidimensional. A Loevinger's coefficient of 0.49 was found, indicating an acceptable level of scalability. CONCLUSIONS: PHQ-9 is a measure of potential clinical utility to be used as an overall index of depression, mainly for screening purposes. Substantial revisions, particularly in the wording of over- and under-discriminating items, are needed.

Illness Denial in Medical Disorders: A Systematic Review.

INTRODUCTION: Illness denial pertains to medical patients who do not acknowledge the presence or severity of their disease or the need of treatment. OBJECTIVE: This systematic review was performed to clarify the clinical role and manifestations of illness denial, its impact on health attitudes and behavior, as well as on short- and long-term outcomes in patients with medical disorders. METHODS: The systematic search according to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines was conducted on PubMed, Scopus, and Web of Science. RESULTS: The initial search yielded a total of 14,098 articles; 176 studies met the criteria for inclusion. Illness denial appeared to be a relatively common condition affecting a wide spectrum of health attitudes and behavior. In some cases, it may help a person cope with various stages of illness and treatment. In other situations, it may determine delay in seeking treatment, impaired adherence, and reduced self-management, leading to adverse outcomes. The Diagnostic Criteria for Psychosomatic Research (DCPR) were found to set a useful severity threshold for the condition. An important clinical distinction can also be made based on the DCPR for illness denial, which require the assessment of whether the patient has been provided with an adequate appraisal of the medical situation. CONCLUSIONS: This systematic review indicates that patients with medical disorders experience and express illness denial in many forms and with varying degrees of severity. The findings suggest the need for a multidimensional assessment and provide challenging insights into the management of medical disorders.

Mental Illness and Work-Related Limitations in Healthcare Workers: A Preliminary Retrospective Study.

This retrospective observational study investigated hospital staff requests for job fitness visits, addressed to occupational medicine. Specific objectives were to analyze: (1) health workers' requests, sociodemographic characteristics, psychiatric diagnoses, assigned doctor's fit notes, and (orthopedic, psychiatric) limitations; (2) associations between psychiatric diagnoses, sociodemographic (sex, age), and work-related (job, department) characteristics; (3) associations between the same psychiatric diagnoses/orthopedic limitations, fit notes, and/or psychiatric limitations. Data of St. Orsola-Malpighi Polyclinic health workers (N = 149; F = 73.8%; mean age = 48 ± 9.6 years), visited by both the occupational medicine physician and psychiatrist (January 2016−May 2019), were analyzed. 83.2% of the sample presented with at least one psychiatric diagnosis, including mood (47%), anxiety (13.4%), and anxious-depressive (10.7%) disorders. Significant differences between psychiatric diagnoses according to sex and fit notes (both p < 0.01) have been found, whereas no significant associations based on age and work-related characteristics have been observed. Analysis of frequencies of participants with the same psychiatric diagnosis (orthopedic limitation being equal), according to doctor's fit notes and psychiatric work limitations, showed a high heterogeneity of assignments. The current occupational medicine procedure for fit notes/job limitations assignments does not allow taking into consideration clinical factors possibly associated with more specific assignments. To standardize the procedure and translate the psychiatrist's clinical judgment into practice, further studies to test the usefulness of clinimetrics, which might represent a reliable approach in considering different fit notes and job limitations, are needed.

Cross-cultural validity of the WHO-5 Well-Being Index and Euthymia Scale: A clinimetric analysis.

BACKGROUND: The assessment of psychological well-being and euthymia represents an emerging issue in clinical psychology and psychiatry. Rating scales and indices such as the 5-item version of the World Health Organization Well-Being Index (WHO-5) and the Euthymia Scale (ES) were developed but insufficient attention has been devoted to the evaluation of their cross-cultural validity. This is the first study using Clinimetric Patient-Reported Outcome Measures (CLIPROM) criteria to assess cross-cultural validity and sensitivity of five different versions of the WHO-5 and ES. METHODS: A multicenter cross-sectional study involving a total of 3762 adult participants from different European (i.e., Italy, Poland, Denmark) and non-European (i.e., China, Japan) countries was conducted. Item Response Theory models (Mokken and Rasch analyses) were applied. RESULTS: Mokken coefficients of scalability were found to range from 0.42 to 0.84. The majority of the versions of the WHO-5 fitted the Rasch model expectations. Paired t-tests revealed that the Italian and Danish WHO-5 versions were unidimensional. Person Separation Reliability indices showed that the Polish, Danish, and Japanese ES versions could reliably discriminate between subjects with different levels of euthymia. LIMITATIONS: A convenience sampling was used, thus limiting the generalizability of study findings. In addition, no measures of negative mental health were administered. CONCLUSIONS: WHO-5 can be used in international studies for cross-cultural comparisons since it covers transcultural components of subjective well-being. Findings also suggest that the ES can be used as a cross-cultural screening tool since it entailed the clinimetric property of sensitivity.

Measurement Invariance and Construct Validity of the Satisfaction With Life Scale (SWLS) in Community Volunteers in Vietnam.

Worldwide, the Satisfaction With Life Scale (SWLS) has become the most widely used measure of life satisfaction. Recently, an authorized Vietnamese-language version has been introduced. Using a convenience sample comprising community volunteers from Ho Chi Minh City (N = 1073), confirmatory support was found for the cross-national constancy of the one-dimensional structure underlying the SWLS. Corrected item-total polyserial correlations and Omega coefficient were satisfactory. Using multi-group confirmatory factor analysis, configural, metric, and scalar invariance of the SWLS factorial structure were tested by gender, age, marital status, income, and educational level. Strong evidence of scalar invariance was found for gender and education, on which relevant subgroups did not differ in terms of latent means. Partial scalar invariance was found for marital status (item 4 and 5) and income (item 4). Being involved in an intimate relationship or having a higher income were associated with higher latent means. Scalar invariance in relation to age was very poor. Accordingly, caution must be exerted when comparing age groups. A high SWLS score was predictive of good self-rated health. Implications of the findings are briefly discussed.

The Psychological Impact of COVID-19 among Women Accessing Family Care Centers during Pregnancy and the Postnatal Period in Italy.

There has been concern about the impact of the COVID-19 outbreak on women's mental health during the perinatal period. We conducted a cross-sectional web-based study aimed at evaluating the psychological impact (BSI-18) of the COVID-19 pandemic on this population and collecting information on the perinatal experiences (COPE-IS) during the second Italian wave. Overall, 1168 pregnant women, and 940 within the first six months after childbirth, were recruited in selected Italian Family Care Centers from October 2020 to May 2021. The prevalence of psychological distress symptoms during pregnancy was 12.1% and 9.3% in the postnatal group. Financial difficulties, a previous mood or anxiety disorder and lack of perceived social support and of support provided by health professionals were associated to psychological distress symptoms in both groups. A third of the women felt unsupported by their social network; 61.7% of the pregnant women experienced changes in antenatal care; 21.2% of those in the postnatal period gave birth alone; more than 80% of the participants identified access to medical and mental health care and self-help as important resources in the present context. Health services should assure enhanced support to the most vulnerable women who face the perinatal period during the pandemic.

Charlson Comorbidity Index: A Critical Review of Clinimetric Properties.

The present critical review was conducted to evaluate the clinimetric properties of the Charlson Comorbidity Index (CCI), an assessment tool designed specifically to predict long-term mortality, with regard to its reliability, concurrent validity, sensitivity, incremental and predictive validity. The original version of the CCI has been adapted for use with different sources of data, ICD-9 and ICD-10 codes. The inter-rater reliability of the CCI was found to be excellent, with extremely high agreement between self-report and medical charts. The CCI has also been shown either to have concurrent validity with a number of other prognostic scales or to result in concordant predictions. Importantly, the clinimetric sensitivity of the CCI has been demonstrated in a variety of medical conditions, with stepwise increases in the CCI associated with stepwise increases in mortality. The CCI is also characterized by the clinimetric property of incremental validity, whereby adding the CCI to other measures increases the overall predictive accuracy. It has been shown to predict long-term mortality in different clinical populations, including medical, surgical, intensive care unit (ICU), trauma, and cancer patients. It may also predict in-hospital mortality, although in some instances, such as ICU or trauma patients, the CCI did not perform as well as other instruments designed specifically for that purpose. The CCI thus appears to be clinically useful not only to provide a valid assessment of the patient's unique clinical situation, but also to demarcate major diagnostic and prognostic differences among subgroups of patients sharing the same medical diagnosis.

Clinimetric properties of the Chinese version of the Euthymia Scale.

The present study was conducted to primarily evaluate the clinimetric sensitivity of the Chinese version of the Euthymia Scale (ES), testing whether this measure discriminated between different groups of patients. Concurrent validity, a clinimetric property that refers to the assessment of the extent to which the rating scale under examination correlates with another related, previously validated, assessment instrument, was also tested investigating whether the ES significantly and negatively correlated with measures of depression and anxiety. A cross-sectional study was conducted. A total of 295 inpatients were recruited from different medical settings and included in this study. In addition to the ES, participants completed the PHQ-9 for the assessment of depression and the GAD-7 for the evaluation of symptoms of generalized anxiety. The clinimetric sensitivity of the ES was evaluated using the Mann-Whitney test and the Kruskal-Wallis analysis of variance, whereas the concurrent validity was tested via Spearman's correlation coefficients. The ES total score and its subscales of psychological flexibility and well-being discriminated between different groups of inpatients and sensitively differentiated depressed from non-depressed patients. Negative and statistically significant correlations between the ES and measures of depression and anxiety were found. Findings of the present study indicate that the Chinese version of the ES is a valid and sensitive clinimetric index that can be used not only to differentiate depressed from non-depressed patients but also as a screening measure to detect vulnerability to depression in a wide range of medical patients.

The Hopkins Symptom Checklist (SCL-90-R): A Patient-Reported Outcome Measure in Parkinson's Disease.

Objective: This is the first study applying Clinimetric Patient-Reported Outcome Measures (CLIPROM) criteria to evaluate the construct validity, sensitivity, and clinical utility of the SCL-90-R in patients with Parkinson's disease (PD). Methods: A Rasch analysis was conducted using a sample of 488 PD outpatients. Results: Testing for dimensionality revealed that less than 5% of t-tests were significant, indicating that the SCL-90-R subscales entailed the property of construct validity. As to the total score, a Person Separation Reliability Index of .96 was found. Conclusions: The SCL-90-R total score is a sensitive screening measure that can be used not only to differentiate healthy stress reactions from symptoms of psychological distress but also to detect PD patients with an increased risk for psychiatric complications. As to the subscales, the brief versions that did not include misfitting items should be used to assess the severity of specific symptoms of psychological distress affecting PD patients.

Sensitivity and concurrent validity of the Japanese version of the Euthymia scale: a clinimetric analysis.

BACKGROUND: Euthymia is characterized by the lack of mood disorders, the presence of positive affects, psychological flexibility and well-being, a unifying outlook on life, and resistance to stress. The Euthymia Scale (ES) is a 10-item self-rating clinimetric index assessing euthymia. OBJECTIVES: The present study was conducted to examine the clinimetric sensitivity and concurrent validity of the Japanese version of the Euthymia Scale (ES-J). METHODS: A cross-sectional online survey was conducted. The Mini-International Neuropsychiatric Interview was used to determine the presence of past or current major depressive episodes (MDE). The clinimetric sensitivity was evaluated using the Analysis of Variance (ANOVA). Pearson's correlation coefficients were performed to examine the concurrent validity of the ES-J. RESULTS: A total of 1030 eligible participants completed the survey. The ES-J differentiated healthy subjects from complete remission (i.e., those with a past history of MDE without current MDE) (p < 0.001), from those with past or current history of MDE (p < 0.001), subjects with current MDE from those with sub-threshold symptoms of depression (p < 0.001), and healthy participants from subjects with moderate to severe symptoms of psychological distress (p < 0.001). The associations between the ES-J and measures of psychological well-being, resilience, life satisfaction, and social support were significantly positive (0.353 < r < 0.666, p < 0.001). A negative relationship between the ES-J and measures of psychological distress was also found (r = - 0.595, p < 0.001). CONCLUSIONS: The findings of the present study indicated that the ES-J is a valid and highly sensitive clinimetric index, which can be used as a screening measure in the clinical process of assessment of recovery, particularly when symptoms are expected to be mild and/or when dealing with subclinical symptoms of psychological distress and depression. The findings of this study also support the use of the ES-J to detect vulnerability to depression and to identify subjects at higher risk of relapse.

• The ES-J was a highly sensitive clinimetric index.• The ES-J distinguished healthy subjects from those with past or current major depression.• The ES-J was highly sensitive to sub-threshold symptoms of depression.• The ES-J was a valid screening measure.• The ES-J can be used to detect a kind of vulnerability and risk of relapse.

Clinimetric properties of the Smoking Abstinence Expectancies Questionnaire.

Smoking abstinence expectancies are beliefs about negative and positive short-term psychological and physiological consequences of not smoking. The Smoking Abstinence Expectancies Questionnaire (SAEQ) is a widely used Patient-Reported Outcome Measure (PROM) to assess smoking abstinence expectancies. It has four subscales: negative mood, somatic symptoms, harmful consequences, positive consequences. Although studied from a psychometric perspective, the SAEQ needs further evaluation. Clinimetrics, and its Clinimetric Criteria for Patient-Reported Outcome Measures (CLIPROM), offers a robust method to evaluate the SAEQ. We verified construct validity and sensitivity of the Italian version of the SAEQ applying CLIPROM criteria. A total of 293 adult Italian smokers were consecutively enrolled at two smoking cessation clinics and assessed via the SAEQ. Item Response Theory models (i.e., combining Rasch and Mokken analyses) were used to test construct validity and sensitivity. The total score of the SAEQ was not found to be unidimensional but each SAEQ subscale score was. PSI (0.90) indicated that the total score of the SAEQ could reliably discriminate between respondents with different levels of the trait under assessment, whereas SAEQ subscales on negative mood and harmful consequences could reliably distinguish between different groups but not between different subjects (PSI ranging from 0.77 and 0.78). Overall, the total score of the SAEQ is a sensitive screening PROM and can be used at smoking cessation clinics to discriminate between subjects with different levels of smoking abstinence expectancies. SAEQ subscales should be used to detect severity and subjective burden of a wide range of expected effects of nicotine abstinence.

A clinimetric analysis of the euthymia, resilience, and positive mental health scales.

BACKGROUND: Euthymia has been described as a transdiagnostic construct characterized by the absence of mood disturbances and the presence of an integration of psychic forces, such as coping strategy and well-being. A multidimensional measure, the Euthymia Scale (ES), has been proposed to assess it. We investigated construct and concurrent validity of the ES. METHODS: Construct validity was studied via Rasch and Mokken analyses and compared with that of the 11-item Resilience Scale (RS-11) and 9-item Positive Mental Health Scale (PMH-Scale). A total of 951 participants were recruited (77.5% women; 24.86 ± 5.62 years). RESULTS: The ES, RS and PMH demonstrated similar sensitivity and construct validity. Findings indicate minor needs for adjustments only. As expected the ES demonstrated a strong negative correlation with neuroticism. LIMITATIONS: The convenience sample of subjects recruited primarily from female Italian university students and a community-based data collection limit the generalizability of the present findings. The cross-sectional design precludes the assessment of test-retest reliability, predictive and incremental validity. Only self-report measures and a Likert version of the ES were used. CONCLUSIONS: ES is the most comprehensive measure of euthymia. The RS-11 is a valid measure of a specific component of euthymia, namely subjective ability to cope with stress and empower well-being in face of life adversities. The PMH-Scale is a valid measure of overall positive mental health.

Clinimetric Criteria for Patient-Reported Outcome Measures.

Patient-reported outcome measures (PROMs) are self-rated scales and indices developed to improve the detection of the patients' subjective experience. Given that a considerable number of PROMs are available, it is important to evaluate their validity and usefulness in a specific research or clinical setting. Published guidelines, based on psychometric criteria, do not fit in with the complexity of clinical challenges, because of their quest for homogeneity of components and inadequate attention to sensitivity. Psychometric theory has stifled the field and led to the routine use of scales widely accepted yet with a history of poor performance. Clinimetrics, the science of clinical measurements, may provide a more suitable conceptual and methodological framework. The aims of this paper are to outline the major limitations of the psychometric model and to provide criteria for clinimetric patient-reported outcome measures (CLIPROMs). The characteristics related to reliability, sensitivity, validity, and clinical utility of instruments are critically reviewed, with particular reference to the differences between clinimetric and psychometric approaches. Of note is the fact that PROMs, rating scales, and indices developed according to psychometric criteria may display relevant clinimetric properties. The present paper underpins the importance of the clini-metric methodology in choosing the appropriate PROMs. CLIPROM criteria may also guide the development of new indices and the validation of existing PROMs to be employed in clinical settings.

Construct validity of the Smoker Complaint Scale: A clinimetric analysis using Item Response Theory (IRT) models.

A number of rating scales evaluating symptoms of nicotine withdrawal have been developed over the years but insufficient attention has been devoted to the assessment of their clinimetric properties. Clinimetrics, the science of clinical measurements, is an innovative approach, particularly useful for assessing the validity of rating scales. This is the first study using clinimetric principles to test the construct validity of the Smoker Complaint Scale (SCS), a self-rating scale specifically developed to assess acute symptoms of nicotine withdrawal. Construct validity was evaluated via Item Response Theory (IRT) models (i.e., combining Rasch and Mokken analyses). A total of 366 subjects (mean age = 34.0, SD = 11.3 years) participated in the study. IRT analyses showed that SCS was a multidimensional measure of symptoms of nicotine withdrawal, including unidimensional subscales, particularly a four-item subscale (the SCS4), which was found to entail the clinimetric property of construct validity. IRT analyses also revealed that affective symptoms of nicotine withdrawal preceded cognitive ones. The SCS should be considered as an item bank, including a particularly valid subscale, the SCS4 that can be used as a screening or outcome measure to evaluate the severity of cognitive and affective symptoms of nicotine withdrawal. SCS4 is a sensitive clinimetric index which differentiates "ceiling symptoms" of nicotine withdrawal (e.g., "feeling slowed down") from "floor symptoms" of nicotine withdrawal (e.g., "feeling lightheaded") that emerge in the severe form of nicotine withdrawal.

Construct and criterion validity of patient-reported outcomes (PROs) for depression: A clinimetric comparison.

BACKGROUND: A number of patient-reported outcomes (PROs) have been developed but insufficient attention has been devoted to the assessment of their clinimetric properties. Clinimetrics, the science of clinical measurements, has been considered an emerging approach for evaluating reliability and validity of PROs. This is the first study using clinimetric principles to compare the construct and criterion validity of the Major Depression Inventory (MDI), the Beck Depression Inventory-II (BDI-II), the World Health Organization Well-Being Index (WHO-5), three of the most widely used PROs for the assessment of depression. METHODS: Construct validity was evaluated via Item Response Theory (IRT) models (i.e., combining Rasch and Mokken analyses). Using the ICD-10 diagnostic algorithm for any depression as the gold standard, Receiver Operating Characteristic (ROC) curves were performed to examine the criterion validity of PROs. RESULTS: One hundred healthy subjects (73% females, 32.6 ± 10.5 years) participated in the study, giving a response rate of 90.1%. When using IRT analyses, MDI and WHO-5 were found to be reliable and unidimensional, while BDI-II showed lack of unidimensionality. ROC analyses supported the diagnostic accuracy of MDI and the screening properties of WHO-5. LIMITATIONS: The main limitations of the present study are that healthy subjects were assessed only via only self-reported measures and a cross-sectional design was used. CONCLUSIONS: WHO-5 and MDI outperformed BDI-II in terms of construct and criterion validity. WHO-5 should be considered when screening for depression, while MDI should be used as a valid diagnostic instrument and as a unidimensional measure to assess depression severity.

Incremental Validity Of The Diagnostic Criteria For Psychosomatic Research - Revised (DCPR-R) To Clinical Assessment In Primary Care.

Psychosocial problems are highly prevalent among primary care (PC) patients, but they often remain undetected using traditional classification systems. The aim of the present study was to test the incremental validity of the revised version of the Diagnostic Criteria for Psychosomatic Research (DCPR-R), in addition to standard psychiatric assessment based on DSM-5, with regard to the prediction of psychosocial functioning of PC patients. Two-hundred PC patients were consecutively recruited. A comprehensive assessment was performed using two clinical interviews and three self-rating questionnaires (the PsychoSocial Index [PSI], the Short-Form Health Survey [SF-12] and the Illness Attitude Scales [IAS]) for the assessment of psychopathology and psychosocial functioning. Adding the DCPR-R to DSM-5, the amount of explained variance significantly increased by 9% to 16% in the PSI subscales, by 13% in the SF-12 mental component summary, and by 2% to 6% in the IAS scales. The joint use of DCPR-R and DSM-5 thus significantly increased the prediction of psychosocial functioning of primary care patients. These findings further support the use of the DCPR-R in PC settings, particularly in patients who do not satisfy DSM-5 criteria and yet present with high psychological distress, maladaptive illness behavior, impaired psychological well-being and quality of life.

The Hamilton Rating Scales for Depression: A Critical Review of Clinimetric Properties of Different Versions.

The format of the original Hamilton Rating Scale for Depression (HAM-D) was unstructured: only general instructions were provided for rating individual items. Over the years, a number of modified versions of the HAM-D have been proposed. They differ not only in the number of items, but also in modalities of administration. Structured versions, including item definitions, anchor points and semi-structured or structured interview questions, were developed. This comprehensive review was conducted to examine the clinimetric properties of the different versions of the HAM-D. The aim was to identify the HAM-D versions that best display the clinimetric properties of reliability, validity, and sensitivity to change. The search was conducted on MEDLINE, Scopus, Web of Science, and PubMed, and yielded a total of 35,473 citations, but only the most representative studies were included. The structured versions of the HAM-D were found to display the highest inter-rater and test-retest reliability. The Clinical Interview for Depression and the 6-item HAM-D showed the highest sensitivity in differentiating active treatment from placebo. The findings indicate that the HAM-D is a valid and sensitive clinimetric index, which should not be discarded in view of obsolete and not clinically relevant psychometric criteria. The HAM-D, however, requires an informed use: unstructured forms should be avoided and the type of HAM-D version that is selected should be specified in the registration of the study protocol and in the methods of the trial.

Mental Pain as a Transdiagnostic Patient-Reported Outcome Measure.

Patient-reported outcomes (PROs) refer to any report coming directly from patients about how they function or feel in relation to a health condition or its therapy. PROs have been applied in medicine for the assessment of the impact of clinical phenomena. Self-report scales and procedures for assessing physical pain in adults have been developed and used in clinical trials. However, insufficient attention has been dedicated to the assessment of mental pain. The aim of this paper is to outline the implications that assessment of mental pain may entail in psychiatry and medicine, with particular reference to a clinimetric index. A simple 10-item self-rating questionnaire, the Mental Pain Questionnaire (MPQ), encompasses the specific clinical features of mental pain and shows good clinimetric properties (i.e., sensitivity, discriminant and incremental validity). The preliminary data suggest that the MPQ may qualify as a PRO measure to be included in clinical trials. Assessment of mental pain may have important clinical implications in intervention research, both in psychopharmacology and psychotherapy. The transdiagnostic features of mental pain are supported by its association with a number of psychiatric disorders, such as depression, anxiety, eating disorders, as well as borderline personality disorder. Further, addressing mental pain may be an important pathway to prevent and diminish the opioid epidemic. The data summarized here indicate that mental pain can be incorporated into current psychiatric assessment and included as a PRO measure in treatment outcome studies.