Key psychosocial issues in medical care.

OBJECTIVE: The aim of this review is to illustrate an innovative framework for assessing the psychosocial aspects of medical disorders within the biopsychosocial model. It is based on clinimetrics, the science of clinical measurements. It may overcome the limitations of DSM-5 in identifying highly individualized responses at the experiential, behavioral, and interpersonal levels. METHOD: A critical review of the clinimetric formulations of the biopsychosocial model in the setting of medical disease was performed. References were identified through searches from PubMed for English articles on human subjects published from January 1982 to October 2023. RESULTS: Clinimetric methods of classification have been found to deserve special attention in four major areas: allostatic load (the cumulative cost of fluctuating and heightened neural or neuroendocrine responses to environmental stressors); health attitudes and behavior; persistent somatization; demoralization and irritable mood. This type of assessment, integrated with traditional psychiatric nosography, may disclose pathophysiological links and provide clinical characterizations that demarcate major prognostic and therapeutic differences among patients who otherwise seem deceptively similar because they have the same medical diagnosis. It may be of value in a number of medical situations, such as: high level of disability or compromised quality of life in relation to what is expected by disease status; delayed or partial recovery; insufficient participation in self-management and/or rehabilitation; failure to resume healthy role after convalescence; unhealthy lifestyle; high attendance of medical facilities disproportionate to detectable disease; lack of treatment adherence; illness denial. CONCLUSIONS: The clinimetric approach to the assessment of key psychosocial variables may lead to unique individual profiles, that take into account both biology and biography. It may offer new opportunities for integrating psychosocial and medical perspectives.

Clinical Interviewing: An Essential but Neglected Method of Medicine.

Clinical interviewing is the basic method to understand how a person feels and what are the presenting complaints, obtain medical history, evaluate personal attitudes and behavior related to health and disease, give the patient information about diagnosis, prognosis, and treatment, and establish a bond between patient and physician that is crucial for shared decision making and self-management. However, the value of this basic skill is threatened by time pressures and emphasis on technology. Current health care trends privilege expensive tests and procedures and tag the time devoted to interaction with the patient as lacking cost-effectiveness. Instead, the time spent to inquire about problems and life setting may actually help to avoid further testing, procedures, and referrals. Moreover, the dialogue between patient and physician is an essential instrument to increase patient's motivation to engage in healthy behavior. The aim of this paper was to provide an overview of clinical interviewing and its optimal use in relation to style, flow and hypothesis testing, clinical domains, modifications according to settings and goals, and teaching. This review points to the primacy of interviewing in the clinical process. The quality of interviewing determines the quality of data that are collected and, eventually, of assessment and treatment. Thus, interviewing deserves more attention in educational training and more space in clinical encounters than it is currently receiving.

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.

Promoting weight loss and psychological well-being in patients with obesity: A sequential combination of behavioural lifestyle intervention and well-being therapy.

Behavioural lifestyle interventions focused on diet and physical activity are a cornerstone for the treatment of obesity. However, their effects vary substantially across individuals in terms of magnitude and durability. Personalized approaches that target psychological well-being may be promising to facilitate healthy behaviours and sustained weight loss. This preliminary study aimed to explore whether the sequential combination of behavioural lifestyle intervention (BLI) and well-being therapy (WBT) may result in more favourable outcomes than BLI alone in promoting weight loss (primary outcome) and improving psychological well-being, distress, dietary behaviours and physical activity (secondary outcomes). A total of 83 patients with obesity were randomly assigned to BLI/WBT (N = 38) or BLI group (N = 45). The BLI group received a 12-week behavioural weight loss programme, whereas the BLI/WBT group received the same programme followed by an additional 4-week WBT, adapted for group interventions. Data were collected at pretreatment (baseline, T1), at the end of BLI/WBT (T2), at 6-month (T3) and 12-month (T4) follow-ups. There was a significant weight loss in both treatment groups at T2, T3 and T4. The BLI/WBT group showed greater improvements in depressive symptoms at T3 and T4, in autonomy at T2, in personal growth at T4 and in global well-being at T4 compared with BLI group. WBT yielded no additional effect on weight loss. However, the secondary outcomes indicate that WBT may have enduring effects that reduce vulnerability to psychological distress in patients with obesity. In order to confirm these preliminary findings and explore whether a more intensive and individualized WBT can foster sustained weight loss, future studies are needed.

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.

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.

The Role of Psychological Well-Being in Weight Loss: New Insights from a Comprehensive Lifestyle Intervention / El papel del bienestar psicológico en la pérdida de peso: nuevos conocimientos acerca de una intervención integral en el estilo de vida

Background/Objective: Although the literature suggested that impaired psychological well-being (PWB) is associated with obesity, evidence on the role of PWB in weight outcomes is limited and inconclusive.This research aimed to investigate the joint role of PWB in achieving clinically significant weight loss (CWL; loss of 5% of the initial weight) through a comprehensive lifestyle intervention for obesity using a broad-based evaluation. Method: This study is a prospective cohort of 96 patients with obesity attending a comprehensive lifestyle intervention for weight loss. Data on weight, lifestyle, PWB, and distress, were collected before and after the intervention. Results: 30.5% of the participants achieved CWL at the end of treatment. A more pronounced increase in autonomy (odds ratio = 0.80 [95% CI: 0.68, 0.93], p ≤ .01) and somatization (odds ratio = 0.83 [95%CI: 0.70, 0.98], p ≤ .05) from pre- to post-treatment were independently associated with a lower probability of CWL. Conclusions: Unbalanced dimensions of PWB, in particular exceedingly high autonomy, may contribute to a poor weight loss outcome. This study paves the way for the addition of psychotherapeutic strategies geared to euthymia in comprehensive lifestyle intervention.

Antecedentes/Objetivo: Aunque la literatura sugiere que el deterioro del bienestar psi-cológico (BP) está asociado con obesidad, la evidencia sobre el papel del BP en el peso es limitada. Se investiga el papel del BP en el logro de pérdida de peso clínicamente signi-ficativa (PPCS; pérdida del 5% del peso inicial) a través de una intervención integral sobre el estilo de vida con respecto a la obesidad. Método: Cohorte prospectiva de 96 pacientes con obesidad que asisten a una intervención integral sobre el estilo de vida para la pér-dida de peso. Se recolectaron datos sobre peso, estilo de vida, BP y angustia, antes y después de la intervención. Resultados: El 30,5% de los participantes lograron pérdida de peso al final del tratamiento. Mayor aumento de autonomía (razón de momios = 0,80 [ICdel 95%: 0,68, 0,93], p ≤ 0,01) y somatización (razón de momios = 0,83 [IC del 95%: 0,70, 0,98], p ≤ 0,05) de antes a después del tratamiento se asociaron de forma independiente con menor probabilidad de PPCS. Conclusiones: Las dimensiones desequilibradas del BP, en particular la autonomía excesivamente alta, pueden contribuir a una pérdida de peso insuficiente. Se allana el camino para añadir estrategias psicoterapéuticas orientadas a la eutimia en la intervención integral en el estilo de vida.

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.

The Role of Psychological Well-Being in Weight Loss: New Insights from a Comprehensive Lifestyle Intervention.

BACKGROUND/OBJECTIVE: Although the literature suggested that impaired psychological well-being (PWB) is associated with obesity, evidence on the role of PWB in weight outcomes is limited and inconclusive. This research aimed to investigate the joint role of PWB in achieving clinically significant weight loss (CWL; loss of 5% of the initial weight) through a comprehensive lifestyle intervention for obesity using a broad-based evaluation. METHOD: This study is a prospective cohort of 96 patients with obesity attending a comprehensive lifestyle intervention for weight loss. Data on weight, lifestyle, PWB, and distress, were collected before and after the intervention. RESULTS: 30.5% of the participants achieved CWL at the end of treatment. A more pronounced increase in autonomy (odds ratio = 0.80 [95% CI: 0.68, 0.93], p ≤ .01) and somatization (odds ratio = 0.83 [95% CI: 0.70, 0.98], p ≤ .05) from pre- to post-treatment were independently associated with a lower probability of CWL. CONCLUSIONS: Unbalanced dimensions of PWB, in particular exceedingly high autonomy, may contribute to a poor weight loss outcome. This study paves the way for the addition of psychotherapeutic strategies geared to euthymia in comprehensive lifestyle intervention.

CONTEXTO/OBJETIVO: Aunque la literatura sugiere que el deterioro del bienestar psicológico (BP) está asociado con obesidad, la evidencia sobre el papel del BP en el peso es limitada. Se investiga el papel del BP en el logro de pérdida de peso clínicamente significativa (PPCS; pérdida del 5% del peso inicial) a través de una intervención integral sobre el estilo de vida con respecto a la obesidad. MÉTODO: Cohorte prospectiva de 96 pacientes con obesidad que asisten a una intervención integral sobre el estilo de vida para la pérdida de peso. Se recolectaron datos sobre peso, estilo de vida, BP y angustia, antes y después de la intervención. RESULTADOS: El 30,5% de los participantes lograron pérdida de peso al final del tratamiento. Mayor aumento de autonomía (razón de momios = 0,80 [IC del 95%: 0,68, 0,93], p ≤ 0,01) y somatización (razón de momios = 0,83 [IC del 95%: 0,70, 0,98], p ≤ 0,05) de antes a después del tratamiento se asociaron de forma independiente con menor probabilidad de PPCS. CONCLUSIONES: Las dimensiones desequilibradas del BP, en particular la autonomía excesivamente alta, pueden contribuir a una pérdida de peso insuficiente. Se allana el camino para añadir estrategias psicoterapéuticas orientadas a la eutimia en la intervención integral en el estilo de vida.

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.

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.

Negative Affectivity Predicts Lower Quality of Life and Metabolic Control in Type 2 Diabetes Patients: A Structural Equation Modeling Approach.

Introduction: It is essential to consider the clinical assessment of psychological aspects in patients with Diabetes Mellitus (DM), in order to prevent potentially adverse self-management care behaviors leading to diabetes-related complications, including declining levels of Quality of Life (QoL) and negative metabolic control. Purpose: In the framework of Structural Equation Modeling (SEM), the specific aim of this study is to evaluate the influence of distressed personality factors as Negative Affectivity (NA) and Social Inhibition (SI) on diabetes-related clinical variables (i.e., QoL and glycemic control). Methods: The total sample consists of a clinical sample, including 159 outpatients with Type 2 Diabetes Mellitus (T2DM), and a control group composed of 102 healthy respondents. All participants completed the following self- rating scales: The Type D Scale (DS14) and the World Health Organization QoL Scale (WHOQOLBREF). Furthermore, the participants of the clinical group were assessed for HbA1c, disease duration, and BMI. The observed covariates were BMI, gender, and disease duration, while HbA1c was considered an observed variable. Results: SEM analysis revealed significant differences between groups in regards to the latent construct of NA and the Environmental dimension of QoL. For the clinical sample, SEM showed that NA had a negative impact on both QoL dimensions and metabolic control. Conclusions: Clinical interventions aiming to improve medication adherence in patients with T2DM should include the psychological evaluation of Type D Personality traits, by focusing especially on its component of NA as a significant risk factor leading to negative health outcomes.

Somatization in Parkinson's Disease: A systematic review.

The current systematic review study is aimed at critically analyzing from a clinimetric viewpoint the clinical consequence of somatization in Parkinson's Disease (PD). By focusing on the International Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we conducted a comprehensive electronic literature research strategy on ISI Web-of-Science, PsychINFO, PubMed, EBSCO, ScienceDirect, MEDLINE, Scopus, and Google Scholar databases. Out of 2.926 initial records, only a total of 9 studies were identified as clearly relevant and analyzed in this systematic review. The prevalence of somatization in PD has been found to range between 7.0% and 66.7%, with somatoform disorders acting as clinical factor significantly contributing to predict a progressive cognitive impairment. We highlighted that somatization is a highly prevalent comorbidity affecting PD. However, the clinical consequence of such psychiatric symptom should be further evaluated by replacing the clinically inadequate diagnostic label of psychogenic parkinsonism with the psychosomatic concept of persistent somatization as conceived by the Diagnostic Criteria for Psychosomatic Research (DCPR).

The Clinical Link between Type D Personality and Diabetes.

INTRODUCTION: Type D personality consists of a mixture of high levels of negative affectivity and social inhibition, resulting in a stable tendency to experience negative emotions, by inhibiting the expression of these emotions. We have reanalyzed the clinically relevant studies examining the role of this personality profile in diabetes, by providing a qualitative synthesis of the data. In this regard, the aim of this study is to provide a systematic review by evaluating the clinical link between Type D personality and diabetes. METHOD: When focusing on PRISMA guidelines, we have performed a comprehensive research of the literature on PubMed, Scopus, ScienceDirect, ISI Web of Science, PsycINFO, and Google Scholar by using search terms as "distressed personality" OR (i.e., Boolean operator) "Type D personality" combined with the Boolean "AND" operator with "diabetes." RESULTS: A total of seven research studies were identified and included in the review. Type D was found to be more prevalent in diabetes patients than controls. As regards the specific association with diabetes variables, Type D personality is a significant predictor of both poor medication adherence and unhealthy behaviors, by predicting negative mental health consequences also (i.e., depressed mood, anhedonia, and anxiety). CONCLUSION: Our review emphasized for the first time that Type D personality affects clinical factors in patients with diabetes by provoking adverse outcomes. The core implication of the study comprises the clinical relevance to detect, from a clinimetric point of view, Type D personality in diabetes in order to prevent potentially negative clinical outcomes.