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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.

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.

Prodromal symptoms were investigated in 30 patients with obsessive-compulsive disorder. The large majority of patients (93%) reported at least one prodromal symptom before disease onset. Generalized anxiety, irritability, indecision, phobic and somatic anxiety occurred in about half of patients. Also common were depressive symptoms such as fatigue, lowered self-esteem, depressed mood, pessimism, impaired work, and guilt. The results suggest a close association of obsessions and compulsions with affective symptoms.

The measures of disease status alone are insufficient to describe the burden of illness or one’s attitudes toward illness and life. The subjective health status including psychological resources and well-being, is as valid as that of the clinician when it comes to evaluating outcomes. The aim of this chapter is to provide a theoretical framework for the assessment of psychological well-being and positive functioning and to review the literature supporting the influence of these positive dimensions on illness development and health protection. We selected the assessment tools, such as Kellner’s Symptom Questionnaire, Antonovsky’s Sense of Coherence, Ryff’s Psychological Well-being Scales and Psychosocial Index, that we found most helpful in clinical and psychosomatic practice and that displayed clinimetric properties of sensitivity in research.