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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 clini­metric 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.

Introduction: Patient-reported outcomes (PROs) are of increasing importance in clinical medicine. However, their evaluation by classic psychometric methods carries considerable limitations. The clinimetric approach provides a viable framework for their assessment. Objective: The aim of this paper was to provide a systematic review of clinimetric properties of the Symptom Questionnaire (SQ), a simple, self-rated instrument for the assessment of psychological symptoms (depression, anxiety, hostility, and somatization) and well-being (contentment, relaxation, friendliness, and physical well-being). Methods: The PRISMA guidelines were used. Electronic databases were searched from inception up to March 2019. Only original research articles, published in English, reporting data about the clinimetric properties of the SQ, were included. Results: A total of 284 studies was selected. The SQ has been used in populations of adults, adolescents, and older individuals. The scale significantly discriminated between subgroups of subjects in both clinical and nonclinical settings, and differentiated medical and psychiatric patients from healthy controls. In longitudinal studies and in controlled pharmacological and psychotherapy trials, it was highly sensitive to symptoms and well-being changes and discriminated between the effects of psychotropic drugs and placebo. Conclusions: The SQ is a highly sensitive clinimetric index. It may yield clinical information that similar scales would fail to provide and has a unique position among the PROs that are available. Its use in clinical trials is strongly recommended.

Benzodiazepines (BZs) have been used broadly in gastroenterology, for instance in treating anxiety symptomatology associated with gastrointestinal (GI) illness, or in treating some underlying conditions (e.g., addressing alcohol dependence in liver disease), or in various diagnostic endoscopy procedures, and in preparation for surgery. It is known that anxiety and GI symptomatology/disorders frequently co-exist, with anxiety exacerbating GI disorders, and some GI symptoms provoking anxiety.

The side effects and risks associated with the medical intervention are defined as iatrogenesis. Adverse drug reactions, malpractice, medical error, and negligence constitute common iatrogenic complications. Examples of important syndromes induced by medications are asthma caused by beta-adrenoceptor antagonists, pulmonary fibrosis associated with cytotoxic agents, gastric bleeding and complications with anti-inflammatory agents, torsade de pointes tachycardia with various drugs, abnormal glucose homeostasis with thiazide and corticosteroids, and osteonecrosis of the jaw with bisphosphonates. In psychiatry, iatrogenesis has traditionally been concerned with medical complications of psychotropic drug treatment, such as tardive dyskinesia and insulin resistance with antipsychotic drugs, and cardiac and metabolic disturbances with antidepressant medications. The complications may occur due to direct toxicity, drug-drug interactions, intoxication, or withdrawal from psychotropic medications. In more recent years, attention has also been dedicated to the patient experience of negative effects of psychotherapy, including the interactions between pharmacotherapy and psychotherapy. As it happened with medical therapy, psychiatric treatment has mainly been assessed and evaluated as to its capacity to improve psychiatric symptomatology. Side effects have been conceptualized as the unavoidable drawbacks of any form of medical therapy. Little attention has been paid to the adverse psychological and behavioral effects of psychiatric treatment on psychopathology and illness course. In view of the insufficient body of knowledge on the iatrogenic effects of psychological therapies, we will only concentrate on the effects of psychotropic drug treatment. Many of the insights that have been gained in the past 25 years have originated in this journal.

The relationship between anxiety and cardiovascular disease (CVD) has been known and well-documented for decades. Though more attention has been paid to the relationship between depression and CVD, the evidence of the relationship between anxiety and CVD has been growing. For instance, Goodwin et al. (2009) documented that anxiety disorders are strongly and significantly associated with CVD among adults in the USA. Frasure-Smith and Lesperance (2008), among others, found that, not just depression but also anxiety predicted a greater risk of major adverse cardiac events such as cardiac death, myocardial infarction, or cardiac arrest in patients with stable coronary artery disease. Less attention has been paid to the possible benefits of anxiolytic medications, such as benzodiazepines (BZs), for patients with CVD and anxiety or possible full-blown anxiety disorder.

HART) [7] , on depressed patients after CAD, found that the effect of sertraline was greater in patients with severe and recurrent depression. It is also true that, in cardiac settings, mild depressive symptoms are sufficient to enhance cardiovascular risk even in the absence of major depressive disorder [8–11] . Antidepressant treatment could thus be successful in terms of cardiac prognosis only in the subgroup of cardiac patients with more severe depression, but not in those with milder depression at equally elevated cardiac risk. It has been suggested that selective serotonin reuptake inhibitors (SSRIs) might ameliorate the adverse effect of depression on cardiovascular disease through the inhibition of platelet aggregation, even independently of changes in depression [12] . This potential benefit, however, is counteracted by recognized adverse cardiovascular side effects [13–15] . In particular, the use of SSRIs such as citalopram and escitalopram is associated with cases of arrhythmias and prolonged QTc interval on electrocardiogram in patients lacking cardiovascular disorders [16] . Licht et al. [17] found that all antidepressants, including SSRIs, have a lowering effect on cardiac vagal control that has been found to be associated with increased blood pressure and other metabolic abnormalities, such as unfavorable lipid profiles and high glucose levels [18] . A significant relationship between depression and cardiac morbidity has been documented [1] . The identification of depression as an unfavorable marker of the clinical course in coronary artery disease (CAD) in the 1990s [2– 4] generated the hope of improving the prognosis of cardiovascular disease with treatment of depression. This hope, however, has not survived the test of time. In a Cochrane review on randomized controlled clinical trials (RCTs) of any length of treatment and any length of follow-up [5] , psychological and pharmacological interventions have shown a small yet clinically meaningful effect on depression outcomes in CAD patients. However, no beneficial effects on the reduction of mortality rates and cardiac events have been found. Indeed, in some cases, treatment of depression was found to entail negative physical consequences. There are several potential explanations, involving drugs and psychotherapy, which account for this phenomenon.

Background: There is a lack of controlled studies of psychological treatment of cyclothymic disorder. The aim of this investigation was to examine the benefits of the sequential combination of cognitive behavioral therapy (CBT) and well-being therapy (WBT) compared to clinical management (CM) in DSM-IV cyclothymic disorder. Methods: Sixty-two patients with DSM-IV cyclothymic disorder were randomly assigned to CBT/WBT (n = 31) or CM (n = 31). Both CBT/WBT and CM consisted of ten 45-min sessions every other week. An independent blind evaluator assessed the patients before treatment, after therapy, and at 1- and 2-year follow-ups. The outcomes included total score of the change version of the Clinical Interview for Depression, and the Mania Scale. All analyses were performed on an intent-to-treat basis. Results: Significant differences were found in all outcome measures, with greater improvements after treatment in the CBT/WBT group compared to the CM group. Therapeutic gains were maintained at 1- and 2-year follow-ups. Conclusions: A sequential combination of CBT and WBT, which addresses both polarities of mood swings and comorbid anxiety, was found to yield significant and persistent benefits in cyclothymic disorder.

Psychometric theory is the basis for the development of assessment instruments in psychiatric research. However, the psychometric model appears to be largely inadequate in the clinical setting because of its lack of sensitivity to change and its quest for homogeneous components. Clinimetrics offers a viable alternative to psychometrics, both from a conceptual and a methodological viewpoint. Current diagnostic entities (DSM) are based on clinimetric principles, but their use is still influenced by psychometric models. Suggestions for switching gears in assessment research are offered.

Background: While the effect of psychological stress and depression on the course of heart disease is commonly recognized, the relationship between recent life events, major depression, depressive symptomatology and the onset of acute coronary heart disease (CHD) has been less considered. The aim of this study was to investigate the presence of stressful life events, major and minor depression, recurrent depression and demoralization in the year preceding the occurrence of a first acute myocardial infarction (AMI) and/or a first episode of instable angina and to compare stressful life events, also related with mood disorders, in patients and healthy controls. Methods: 97 consecutive patients with a first episode of CHD (91 with AMI and 6 with instable angina) and 97 healthy subjects matched for sociodemographic variables were included. All patients were interviewed with Paykel’s Interview for Recent Life Events, a semistructured interview for determining the psychiatric diagnosis of mood disorders (DSM-IV), a semistructured interview for demoralization (DCPR). Patients were assessed while on remission from the acute phase. The time period considered was the year preceding the first episode of CHD and the year before the interview for controls. Results: Patients with acute CHD reported significantly more life events than control subjects (p < 0.001). All categories of events (except entrance events) were significantly more frequent. 30% of patients were identified as suffering from a major depressive disorder; 9% of patients were suffering from minor depression, 20% from demoralization. Even though there was an overlap between major depression and demoralization (12%), 17% of patients with major depression were not classified as demoralized and 7% of patients with demoralization did not satisfy the criteria for major depression. Independently of mood disorders, patients had a higher (p < 0.001) mean number of life events than controls. With regard to life events, the same significant difference (p < 0.001) compared to controls applied to patients with and without mood disorders. Conclusions: Our findings emphasize, by means of reliable methodology, the relationship between life events and AMI. These data, together with those regarding traditional cardiac risk factors, may have clinical and prognostic implications to be verified in longitudinal studies.

Background: The concept of psychological well-being has been neglected for a long time in scientific literature. Over the last decades, however, many psychometric instruments have been developed to measure it. The aim of the present study was to analyze the concept of psychological well-being and its relationship to distress and personality traits. It is clinically and empirically important to establish where the measures of well-being are located in relation to symptomatology indices and personality traits. Methods: A sample of 450 subjects in the general population completed three self-rating scales for the assessment of symptomatology (Kellner’s Symptom Questionnaire), psychological well-being (Ryff’s Psychological Well-Being Scales, PWB), and personality traits (Cloninger’s Tridimensional Personality Questionnaire). The assessment was repeated after 1 month. Pearson’s coefficient was used to analyze PWB test-retest reliability and correlations between well-being, distress and personality indicators. Exploratory factor analysis was performed for both assessments. Results: Test-retest Pearson’s coefficients were satisfactory for all six PWB scales. Exploratory factor analyses showed a 4- or 5-factor structure, where well-being, distress and personality remained separated. PWB scales were negatively and significantly correlated with all symptom scales, but only with one personality dimension, TPQ Harm Avoidance. Mean-level differences by gender showed that in general women significantly presented with lower levels of well-being (except in Positive Relations) and higher levels of distress and personality disturbances. Conclusions: The results suggest that the relationship of well-being to distress and personality is complex. Psychological well-being could not be equated with the absence of symptomatology or with personality traits. PWB scales measure an attitude toward optimal functioning that is crucial for a comprehensive consideration of individuals in clinical settings.