Minimal important change and difference in health outcome: An overview of approaches, concepts, and methods.

OBJECTIVE: To provide an overview of approaches, concepts, and methods used to define and assess minimal important change and difference in health outcome. METHOD: A narrative review of the literature, guided by a conceptual framework. RESULTS: We distinguish between (i) interpretation of health outcome in individuals versus groups, (ii) change within individuals or groups versus difference between change within individuals or groups; and (iii) the responder approach (based on the proportion of patients that obtain a defined response) versus the group average approach (based on the average amount of change in a group). We review approaches, concepts, and methods. CONCLUSION: By bringing together and juxtaposing various approaches, concepts, and methods, we set a precursory step in the direction of consensus building in the field concerned with defining and assessing minimal important change and difference in health outcome. We emphasize the need for conceptual clarification and terminological standardization. We argue that assessing minimal importance of change and difference in health outcome is essentially a value judgment involving a range of considerations and perspectives.

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.

Staging models in eating disorders: A systematic scoping review of the literature.

Eating Disorders (ED) are characterized by low remission rates, treatment drop-out, and residual symptoms. To improve assessment and treatment of ED, the staging approach has been proposed. This systematic scoping review is aimed at mapping the existing staging models that explicitly propose stages of the progression of ED. A systematic search of PubMed, PsycINFO, Scopus was conducted with the terms staging, anorexia nervosa, bulimia nervosa, binge-eating disorders, eating disorders. Eleven studies met inclusion criteria presenting nine ED staging models, mostly for anorexia nervosa. Three were empirically tested, one of which was through an objective measure specifically developed to differentiate between stages. Most staging models featured early stages in which the exacerbation of EDs unfolds and acute phases are followed by chronic stages. Intermediate stages were not limited to acute stages, but also residual phases, remission, relapse, and recovery. The criteria for stage differentiation encompassed behavioral, psychological, cognitive, and physical features including body mass index and illness duration. One study recommended stage-oriented interventions. The current review underscores the need to empirically test the available staging models and to develop and test new proposals of staging models for other ED populations. The inclusion of criteria based on medical features and biomarkers is recommended. Staging models can potentially guide assessment and interventions in daily clinical settings.

Clinimetric Properties of the Working Alliance Inventory and Credibility Expectancy Questionnaire: Screening Options for Musculoskeletal Pain.

OBJECTIVE: To investigate clinimetric properties of 2 surveys used to evaluate common factors in the patient-provider relation and present screener options for the assessment of common factors and report their correlation with pain and functional outcomes. DESIGN: Observational cohort. SETTING: Outpatient physical therapy. PARTICIPANTS: 100 individuals (58% women, mean age=34, SD=15; N=100) presenting to physical therapy with musculoskeletal pain in the following regions: 44% lower extremity, 36% spine, 19% upper extremity, 1% undetermined. INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: Participants completed the Working Alliance Inventory (WAI) and the Credibility and Expectancy Questionnaire (CEQ). Exploratory factor analysis (EFA) explored factor structure of the WAI and CEQ. Internal consistency was evaluated for scales derived from items retained based on factor loadings. Finally, options for screener tools were proposed and assessed based on their correlation to original surveys as well as pain and functional outcomes. RESULTS: The data supported a 4-factor structure for the surveys. Some WAI items were excluded due to cross-loading. The derived four-factor scales demonstrated strong correlations with the original surveys (r=.89-.99) and exhibited good internal consistency (α=.824-.875). Two screening options were suggested: 1 retaining 11 of the original 18 items and the other comprising just 3 items. Both screening tools correlated with the original surveys and showed associations with improvements in pain and functional outcomes (r=-.21-.34). CONCLUSION: The proposed screeners provide concise measurement options to facilitate use in clinical practice. These tools can aid in facilitating patient communication specifically addressing patient expectation and understanding the tasks required to enact behavior change.

It Is as It Was: MDS-UPDRS Part III Scores Cannot Be Combined with Other Parts to Give a Valid Sum.

BACKGROUND: Original clinimetric analyses by the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) developers did not confirm the validity of summing the scores of its parts. Recent studies used the summed score of Part III and other parts as efficacy outcomes. OBJECTIVE: The aim of this study was to establish whether summing scores of MDS-UPDRS parts can be recommended. METHODS: Using 7466 full MDS-UPDRS scores, we applied two-step factor analysis as in the original article to reassess the validity analysis with the threshold criterion set at comparative fit index ≥0.9. RESULTS: All comparative fit indexes of any combination including Part III were lower than 0.90. CONCLUSIONS: Summing Part III MDS-UPDRS scores with other parts is not clinimetrically sound. The MDS-UPDRS is a validated four-part scale with corresponding individual part scores and needs to be used within the limits originally presented. © 2022 International Parkinson and Movement Disorder Society.

Allostatic Load in Children and Adolescents: A Systematic Review.

INTRODUCTION: The concept of allostatic load encompasses the cumulative effects of both ordinary daily life events as well as major challenges, and also includes related health-damaging behavior. Allostatic overload ensues when environmental challenges exceed the individual's ability to cope. Identification of allostatic load is carried out through the use of biomarkers and clinimetric criteria. Studies are increasingly reported on allostatic load in younger populations, yet a systematic review is missing. OBJECTIVE: The aim of the present systematic review was to summarize the current knowledge on allostatic load/overload among children and adolescents. METHODS: PubMed, PsycINFO, Web of Science, and the Cochrane Library were searched from inception to April 2023. A manual search of the literature was also performed. We considered only studies in which allostatic load or overload were adequately described and assessed in either clinical or non-clinical populations younger than 18 years. RESULTS: A total of 38 original investigations were included in this systematic review. Studies reported an association between allostatic load and sociodemographic characteristics (e.g., poverty, ethnicity, perceived discrimination, adverse childhood experiences) and environmental factors, as well as consequences of allostatic load on both physical and mental health among children and adolescents. CONCLUSIONS: The findings indicate that greater allostatic load is associated with poorer health outcomes in both clinical and non-clinical pediatric populations, with possible enduring effects. The results support the clinical utility of the transdiagnostic identification of allostatic load and overload in children and adolescents across a variety of settings, with a number of potential clinical implications.

Minimal important difference, patient acceptable symptom state and longitudinal validity of oxford elbow score and the quickDASH in patients with tennis elbow.

BACKGROUND: The Oxford Elbow Score (OES) and the short version of Disabilities of Arms, Shoulder and Hand (QuickDASH) are common patient-reported outcomes for people with elbow problems. Our primary objective was to define thresholds for the Minimal Important Difference (MID) and Patient-Acceptable Symptom State (PASS) for the OES and QuickDASH. The secondary aim was to compare the longitudinal validity of these outcome measures. METHODS: We recruited 97 patients with clinically-diagnosed tennis elbow for a prospective observational cohort study in a pragmatic clinical setting. Fifty-five participants received no specific intervention, 14 underwent surgery (11 as primary treatment and 4 during follow-up), and 28 received either botulinum toxin injection or platelet rich plasma injection. We collected OES (0 to 100, higher is better) and QuickDASH (0 to 100, higher is worse), and global rating of change (as an external transition anchor question) at six weeks, three months, six months and 12 months. We defined MID and PASS values using three approaches. To assess the longitudinal validity of the measures, we calculated the Spearman's correlation coefficient between the change in the outcome scores and external transition anchor question, and the Area Under the Curve (AUC) from a receiver operating characteristics (ROC) analysis. To assess signal-to-noise ratio, we calculated standardized response means. RESULTS: Depending on the method, MID values ranged from 16 to 21 for OES Pain; 10 to 17 for OES Function; 14 to 28 for OES Social-psychological; 14 to 20 for OES Total score, and - 7 to -9 for QuickDASH. Patient-Acceptable Symptom State (PASS) cut offs were 74 to 84 for OES Pain; 88 to 91 for OES Function; 75 to 78 with OES Social-psychological; 80 to 81 with OES Total score and 19 to 23 with Quick-DASH. OES had stronger correlations with the anchor items, and AUC values suggested superior discrimination (between improved and not improved) compared with QuickDASH. OES also had superior signal-to-noise ratio compared with QuickDASH. CONCLUSION: The study provides MID and PASS values for OES and QuickDASH. Due to better longitudinal validity, OES may be a better choice for clinical trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT02425982 (first registered April 24, 2015).

Clinimetrics of the cognitive section of the Italian ALS Cognitive Behavioral Screen (ALS-CBS™).

BACKGROUND: The present study aimed at (1) providing further validity and reliability evidence for the Italian version of the cognitive section of the ALS Cognitive Behavioral Screen (ALS-CBS™) and (2) testing its diagnostics within an Italian ALS cohort, as well as at (3) exploring its capability to discriminate patients from healthy controls (HCs). METHODS: N = 293 non-demented ALS patients were administered the cognitive sections of the ALS-CBS™ and Edinburgh Cognitive and Behavioural ALS Screen (ECAS). N = 96 HCs demographically matched with N = 96 patients were also administered the cognitive section of the ALS-CBS™. In patients, factorial and construct validity, internal reliability, and diagnostics against a defective score on the cognitive section of the ECAS were tested. Case-control discrimination was assessed via a logistic regression. RESULTS: ALS-CBS™ cognitive subscales were underpinned by a simple, unidimensional structure, internally reliable (McDonald's ω = 0.74), and mostly related with ECAS executive and fluency scores (rs = 0.54-0.71). Both raw and age- and education-adjusted scores on the cognitive section of the ALS-CBS™ accurately detected ECAS-defined cognitive impairment (AUC = 0.80 and .88, respectively), yielding optimal error-based, information-based and unitary diagnostics. A cut-off of < 15.374 was identified on adjusted scores. The test was able to discriminate patients from HCs (p < 0.001). DISCUSSION: The cognitive section of the Italian ALS-CBS™ is a valid, reliable, and diagnostically sound ALS-specific screener for detecting frontotemporal, executive-/attentive-based cognitive inefficiency in non-demented ALS patients, being also able to discriminate them from normotypical individuals.

Cross-Cultural Adaptation of the University of Wisconsin Running Injury and Recovery Index in Turkish Runners.

CONTEXT: The University of Wisconsin Running Injury and Recovery Index (UWRI) was developed to evaluate the key elements that runners use to self-assess their own running ability following common running-related injuries. The aim of this study was to translate and culturally adapt the UWRI and to evaluate the psychometric properties of its Turkish version (UWRI-Tr) in runners. DESIGN: Prospective cohort study. METHODS: The study included 129 runners. The UWRI-Tr, the Lower Extremity Functional Scale, the Oswestry Disability Index, the Hip Outcome Score, the International Knee Documentation Committee Subjective Knee Evaluation Form, and the Foot and Ankle Ability Measure were applied for the validation purposes. Internal consistency, reliability, construct validity, and discriminant validity of the UWRI-Tr were tested. RESULTS: The test-retest reliability of the UWRI-Tr was excellent with an intraclass correlation coefficient of .85 and a Cronbach α value of .84. There was a small to strong correlation among the UWRI-Tr and Lower Extremity Functional Scale (r = .278), Oswestry Disability Index (r = -.744), Hip Outcome Score (r = .684), The International Knee Documentation Committee Subjective Knee Evaluation Form (r = .758), and Foot and Ankle Ability Measure (r = .498 and .767), indicating that its construct validity was appropriate for use with Turkish runners. CONCLUSIONS: The UWRI-Tr was shown to be a valid and reliable tool to use in clinical and research settings as a sport-specific measurement tool.

Estimating Quadriceps and Hamstrings Strength Through Myoton Among Recreational Athletes.

CONTEXT: The assessment of strength is one of the most usual practices among professionals involved in health care or sport. Quadriceps and hamstrings are the most commonly assessed muscle groups. Generally, the methods used to assess muscle strength are active and, therefore, alternative passive methods could be useful. Myoton provides measures on 3 mechanical properties of the muscle: tone, elasticity, and stiffness. OBJECTIVE: This study aimed to analyze the association of Myoton, an easy-to-use tool not requiring voluntary stimulus from the subject, with strength values in quadriceps and hamstrings. STUDY DESIGN: Experimental. SETTING: University kinesiology laboratory. PARTICIPANTS: Thirty-eight recreational athletes were evaluated. MAIN OUTCOME MEASURES: Anthropometric and demographic data, Myoton-based measures of vastus lateralis, rectus femoris, vastus medialis, biceps femoris, and semitendinosus, and the maximum voluntary isometric contraction of quadriceps and hamstrings. PROCEDURES: The association was examined using multiple regression models to estimate strength through Myoton-based parameters and different patient characteristics. The models encompassed either 2 or 3 independent variables. RESULTS: The adjusted R2 values for predicting quadriceps strength were .666 for rectus femoris, .726 for vastus lateralis, and .667 for vastus medialis, while in regard to hamstrings, they were .617 for biceps femoris and .604 for semitendinosus. CONCLUSIONS: The main finding was that acceptable relationships were found between muscle strength and Myoton-based parameters when variables such as gender and/or age are considered. Our study reveals a new tool for estimating strength with outstanding advantages: it is easy, time-efficient, adaptable, and highly manageable through the feasible equations provided.

Staging of unipolar depression: systematic review and discussion of clinical implications.

Staging has been increasingly used in unipolar depression since its introduction in the nineties. Several models are available, but their differential features and implications are not completely clear. We systematically reviewed: (a) staging models of longitudinal development of unipolar depression; (b) staging models of treatment-resistant unipolar depression; (c) their applications. MEDLINE, PsycINFO, EMBASE, and Web of Science were examined according to PRISMA guidelines from inception to December 2021. Search terms were: 'stage/staging', combined using the Boolean 'AND' operator with 'psychiatric disorder/mental disorder/depressive/mood disorder'. A total of 169 studies were identified for inclusion: 18 described staging models or applications, 151 described treatment-resistant staging models or applications. Staging models of longitudinal development were found to play a key role in formulating sequential treatment, with particular reference to the use of psychotherapy after pharmacotherapy. Staging methods based on treatment resistance played a crucial role in setting entry criteria for randomized clinical trials and neurobiological investigations. Staging is part of clinimetrics, the science of clinical measurements, and its role can be enhanced by its association with other clinimetric strategies, such as repeated assessments, organization of problematic areas, and evaluation of phenomena that may affect responsiveness. In research, it may allow to identify more homogeneous populations in terms of treatment history that may diminish the likelihood of spurious results in comparisons. In clinical practice, the use of staging in a clinimetric perspective allows clinicians to make full use of the information that is available for an individual patient at a specific time.

The Clinical Science of Euthymia: A Conceptual Map.

Euthymia is a trans-diagnostic construct characterized by lack of mood disturbances; presence of positive affect; balance of psychological well-being dimensions, flexibility, consistency, and resistance to stress. The aim of this critical review is to draw a conceptual map of euthymia. Relationships with other constructs, continuum between euthymia and dysthymia with discomfort as an intermediate area, associations with lifestyle, clinimetric assessment, role of psychotherapeutic interventions, establishment of therapeutic targets, and neurobiological mechanisms are discussed. The model is based on the bipolar nature of well-being dimensions. Euthymia means using allostasis optimally and maintaining a healthy balance that promotes positive aspects of brain and body health through health-promoting behaviors. It may provide a framework for a renewed definition of recovery, for measuring treatment outcome and for targeting interventions, including the sequential administration of therapeutic components. Clinical assessment requires a clinimetric approach encompassing a broad range of aspects, such as allostatic load and lifestyle behaviors, all interacting with each other and contributing to the euthymia/dysthymia balance. Clinimetric indices for assessing euthymia (the Clinical Interview for Euthymia and the Euthymia Scale) and related constructs (the Clinical Interview for Dysthymia and the Semi-Structured Interview for the Diagnostic Criteria for Psychosomatic Research) are presented here. Well-Being Therapy, a psychotherapeutic strategy specifically aimed at pursuing euthymia, relies on self-observation of well-being episodes using a structured diary as a distinct therapeutic ingredient. The clinical science of euthymia may unravel innovative approaches to assessment and treatment of psychiatric and medical disorders, according to a unitary conceptual framework.

Minimal important difference and patient acceptable symptom state for common outcome instruments in patients with a closed humeral shaft fracture - analysis of the FISH randomised clinical trial data.

BACKGROUND: Two common ways of assessing the clinical relevance of treatment outcomes are the minimal important difference (MID) and the patient acceptable symptom state (PASS). The former represents the smallest change in the given outcome that makes people feel better, while the latter is the symptom level at which patients feel well. METHODS: We recruited 124 patients with a humeral shaft fracture to a randomised controlled trial comparing surgery to nonsurgical care. Outcome instruments included the Disabilities of Arm, Shoulder, and Hand (DASH) score, the Constant-Murley score, and two numerical rating scales (NRS) for pain (at rest and on activities). A reduction in DASH and pain scores, and increase in the Constant-Murley score represents improvement. We used four methods (receiver operating characteristic [ROC] curve, the mean difference of change, the mean change, and predictive modelling methods) to determine the MID, and two methods (the ROC and 75th percentile) for the PASS. As an anchor for the analyses, we assessed patients' satisfaction regarding the injured arm using a 7-item Likert-scale. RESULTS: The change in the anchor question was strongly correlated with the change in DASH, moderately correlated with the change of the Constant-Murley score and pain on activities, and poorly correlated with the change in pain at rest (Spearman's rho 0.51, -0.40, 0.36, and 0.15, respectively). Depending on the method, the MID estimates for DASH ranged from -6.7 to -11.2, pain on activities from -0.5 to -1.3, and the Constant-Murley score from 6.3 to 13.5. The ROC method provided reliable estimates for DASH (-6.7 points, Area Under Curve [AUC] 0.77), the Constant-Murley Score (7.6 points, AUC 0.71), and pain on activities (-0.5 points, AUC 0.68). The PASS estimates were 14 and 10 for DASH, 2.5 and 2 for pain on activities, and 68 and 74 for the Constant-Murley score with the ROC and 75th percentile methods, respectively. CONCLUSION: Our study provides credible estimates for the MID and PASS values of DASH, pain on activities and the Constant-Murley score, but not for pain at rest. The suggested cut-offs can be used in future studies and for assessing treatment success in patients with humeral shaft fracture. TRIAL REGISTRATION: ClinicalTrials.gov NCT01719887, first registration 01/11/2012.

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.

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.

Measuring thirst distress of patients in the intensive care unit.

BACKGROUND: Thirst is one of the most intense and distressing symptoms experienced by patients in the intensive care unit (ICU), and no validated measurement tools exist. Validating a thirst measurement tool for the ICU population could be a first step in gaining a better understanding of thirst in ICU patients and aid the development and implementation of strategies regarding the prevention and control of thirst. AIM: The objective of this study was to determine the validity and reliability of the "Thirst distress scale for patients with heart failure (TDS-HF)" in measuring thirst distress in adult ICU patients. METHODS: Content validity was established by an expert panel consisting of ICU nurses, intensivists and five ICU patients. Concurrent validity, known-groups validity and internal consistency were determined in a consecutive sample of 56 awake and oriented ICU patients with a median age of 70 years (IQR: 57-74). RESULTS: Content validity of the TDS-HF in the ICU population was low, with item-content validity indexes between 0.25 and 0.75. Concurrent validity was high as Spearman's correlation between TDS-HF and the numeric rating score (0-10) for thirst distress was 0.71. Internal consistency was high (Cronbach's alpha 0.78). When comparing groups, only higher blood urea nitrogen was significantly related to higher scores on the TDS-HF (P = .003). CONCLUSION: The TDS-HF has high concurrent validity and reliability in measuring thirst distress in ICU patients. Nevertheless, questions remain regarding the applicability and content validity of the scale, which should be further explored before the TDS-HF can be used in the ICU. RELEVANCE FOR CLINICAL PRACTICE: The TDS-HF can be used to explore thirst distress and to evaluate interventions. Individual items of the scale can be used to explore the nature of thirst distress in individual patients.

Reliability and validity of the polish version of the vulnerability to Abuse Screening Scale (VASS).

Our aim was to assess the psychometric properties and reliability of a Polish version of the VASS. This cross-sectional validation study involved 228 patients above 65 years of age. Authors-Designed Questionnaire, the Geriatric Depression Scale, and the Activities of Daily Living Scale were used to assess construct validity. Psychometric properties, reliability and repeatability were assessed. Cronbach's alpha coefficient for the VASS scale was 0.89. Almost all items showed a high correlation value in relation to the others (R > 0.45). A high coefficient of repeatability and narrow limits of agreement were observed in the Bland-Altman analysis. All items analyzed had excellent intraclass correlation coefficient (ICC>0.9) and weighted kappa (κ > 0.9) scores. Very strong, significant correlations with other tools confirm the accuracy of the VASS scale. Our research shows promising validity and reliability Polish version of the VASS scale to assess the risk of elder abuse and neglect.

Measuring Spiritual Needs in a Secular Society: Validation and Clinimetric Properties of the Danish 20-Item Spiritual Needs Questionnaire.

In secular cultures, such as Denmark, tools to measure spiritual needs are warranted to guide existential and spiritual care. We examined the clinimetric properties of the Danish version of the Spiritual Needs Questionnaire (DA-SpNQ-20) based on a digital survey in a test-retest setup. A convenience sample was reached via social media and student platforms. A total of 325 (148 for retest) respondents were included in the analysis. The sample was randomly split into two groups (A and B) and used for exploratory (EFA) and confirmatory factor analysis (CFA) by structural equation modeling, respectively. SpNQ dimensions had an internal consistency with Cronbach's alpha between 0.73 and 0.93. The four factors of the SpNQ were supported by both EFA and CFA as follows: religious needs, existential needs, inner peace needs, and generativity needs. The instrument showed good internal consistency, good test-retest reliability, and acceptable structural validity in the sample of relatively young and healthy persons.

Allostatic Load and Its Impact on Health: A Systematic Review.

INTRODUCTION: Allostatic load refers to the cumulative burden of chronic stress and life events. It involves the interaction of different physiological systems at varying degrees of activity. When environmental challenges exceed the individual ability to cope, then allostatic overload ensues. Allostatic load is identified by the use of biomarkers and clinical criteria. OBJECTIVE: To summarize the current knowledge on allostatic load and overload and its clinical implications based on a systematic review of the literature. METHODS: PubMed, PsycINFO, Web of Science, and the Cochrane Library were searched from inception to December 2019. A manual search of the literature was also performed, and reference lists of the retrieved articles were examined.We considered only studies in which allostatic load or overload were adequately described and assessed in either clinical or non-clinical adult populations. RESULTS: A total of 267 original investigations were included. They encompassed general population studies, as well as clinical studies on consequences of allostatic load/overload on both physical and mental health across a variety of settings. CONCLUSIONS: The findings indicate that allostatic load and overload are associated with poorer health outcomes. Assessment of allostatic load provides support to the understanding of psychosocial determinants of health and lifestyle medicine. An integrated approach that includes both biological markers and clinimetric criteria is recommended.

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.