Research study complexity refers to variables that contribute to the difficulty of a clinical trial or study. This includes variables such as intervention type, design, sample, and data management. High complexity often requires more resources, advanced planning, and specialized expertise to execute studies effectively. However, there are limited instruments that scale study complexity across research designs. The purpose of this study was to develop and establish initial psychometric properties of an instrument that scales research study complexity.

Technical and grammatical principles were followed to produce clear, concise items using language familiar to researchers. Items underwent face, content, and cognitive validity testing through quantitative surveys and qualitative interviews. Content validity indices were calculated, and iterative scale revision was performed. The instrument underwent pilot testing using 2 exemplar protocols, asking participants (n = 31) to score 25 items (e.g., study arms, data collection procedures).

The instrument (Research Complexity Index) demonstrated face, content, and cognitive validity. Item mean and standard deviation ranged from 1.0 to 2.75 (Protocol 1) and 1.31 to 2.86 (Protocol 2). Corrected item-total correlations ranged from .030 to .618. Eight elements appear to be under correlated to other elements. Cronbach’s alpha was 0.586 (Protocol 1) and 0.764 (Protocol 2). Inter-rater reliability was fair (kappa = 0.338).

Initial pilot testing demonstrates face, content, and cognitive validity, moderate internal consistency reliability and fair inter-rater reliability. Further refinement of the instrument may increase reliability thus providing a comprehensive method to assess study complexity and related resource quantification (e.g., staffing requirements).

A short yet reliable cognitive measure is needed that separates treatment and placebo for treatment trials for Alzheimer’s disease. Hence, we aimed to shorten the Alzheimer’s Disease Assessment Scale Cognitive Subscale (ADAS-Cog) and test its use as an efficacy measure.

Secondary data analysis of participant-level data from five pivotal clinical trials of donepezil compared with placebo for Alzheimer’s disease (N = 2,198). Across all five trials, cognition was appraised using the original 11-item ADAS-Cog. Statistical analysis consisted of sample characterization, item response theory (IRT) to identify an ADAS-Cog short version, and mixed models for repeated-measures analysis to examine the effect sizes of ADAS-Cog change on the original and short versions in the placebo versus donepezil groups.

Based on IRT, a short ADAS-Cog was developed with seven items and two response options. The original and short ADAS-Cog correlated at baseline and at weeks 12 and 24 at 0.7. Effect sizes based on mixed modeling showed that the short and original ADAS-Cog separated placebo and donepezil comparably (ADAS-Cog original ES = 0.33, 95% CI = 0.29, 0.40, ADAS-Cog short ES = 0.25, 95% CI =0.23, 0.34).

IRT identified a short ADAS-cog version that separated donepezil and placebo, suggesting its clinical potential for assessment and treatment monitoring.

Modern psychometric methods make it possible to eliminate nonperforming items and reduce measurement error. Application of these methods to existing outcome measures can reduce variability in scores, and may increase treatment effect sizes in depression treatment trials.

We aim to determine whether using confirmatory factor analysis techniques can provide better estimates of the true effects of treatments, by conducting secondary analyses of individual patient data from randomised trials of antidepressant therapies.

We will access individual patient data from antidepressant treatment trials through Clinicalstudydatarequest.com and Vivli.org, specifically targeting studies that used the Hamilton Rating Scale for Depression (HRSD) as the outcome measure. Exploratory and confirmatory factor analytic approaches will be used to determine pre-treatment (baseline) and post-treatment models of depression, in terms of the number of factors and weighted scores of each item. Differences in the derived factor scores between baseline and outcome measurements will yield an effect size for factor-informed depression change. The difference between the factor-informed effect size and each original trial effect size, calculated with total HRSD-17 scores, will be determined, and the differences modelled with meta-analytic approaches. Risk differences for proportions of patients who achieved remission will also be evaluated. Furthermore, measurement invariance methods will be used to assess potential gender differences.

Our approach will determine whether adopting advanced psychometric analyses can improve precision and better estimate effect sizes in antidepressant treatment trials. The proposed methods could have implications for future trials and other types of studies that use patient-reported outcome measures.

Behavioural screening tools may be used to identify at-risk children in resource-limited settings in sub-Saharan Africa. The ASEBA forms (Child Behaviour Checklist and Youth Self-Report) are frequently translated and adapted for use in sub-Saharan African populations, but little is known about their measurement properties in these contexts.

We conducted a systematic review of all published journal articles that used the ASEBA forms with sub-Saharan African samples. We evaluated the reported psychometric properties, as well as the methodological quality of the psychometric evaluations, using COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) guidelines.

Fifty-eight studies reported measurement properties of the ASEBA forms. Most studies came from Southern (n = 29, 50%) or East African (n = 25, 43%) countries. Forty-nine studies (84%) used translated versions of the tool, but details regarding the translation process, if available, were often sparse. Most studies (n = 47, 81%) only reported internal consistency (using coefficient alpha) for one or more subscale. The methodological quality of the psychometric evaluations ranged from ‘very good’ to ‘inadequate’ across all measurement properties, except for internal consistency.

There is limited good quality psychometric evidence available for the ASEBA forms in sub-Saharan Africa. We recommend (i) implementing a standardised procedure for conducting and reporting translation processes and (ii) conducting more comprehensive psychometric evaluations of the translated versions of the tools.

To review the psychometric properties of the questionnaires commonly filled in by children and adolescents to measure circadian preference.

We examined the Morningness-Eveningness Questionnaire for Children and Adolescents (MEQ-CA), the Morningness-Eveningness Scale for Children (MESC) and the Composite Scale of Morningness (CSM). We critically analyzed the reliability, in term of internal consistency (through the Cronbach's alpha) and test-retest reliability (through the correlation coefficient), and the type of validation against external criteria (objective assessment of the sleep/wake cycle, body temperature, hormones and other questionnaires). Fifty studies that reported these data were included in the review: 7 studies used the MEQ-CA, 28 used the MESC and 15 used the CSM.

The percentage of studies reporting at least acceptable levels of internal consistency was high and similar between the three questionnaires. Evidence for test-retest reliability was scant, since only 3 studies were available; it was at least acceptable for the MESC (two studies with a time interval of 1 month), not acceptable for the MEQ-CA (one study with a time interval of 6 months), while no information was available for the CSM. As regards the validation evidence, the MEQ-CA has been validated by the highest number of external criteria (actigraphy, oral body temperature and other questionnaires), followed by the CSM (cortisol sampling and other questionnaires). The MESC has been validated only against self-report measures.

The present state of the art would suggest the use of the MEQ-CA to assess circadian preference in children and adolescents.

Perfectionism is a transdiagnostic risk factor across psychopathology. The Clinical Perfectionism Questionnaire (CPQ) was developed to assess change in order to provide clinical utility, but currently the psychometric properties of the CPQ with adolescents is unknown.

To assess the factor structure and construct validity of the CPQ in female adolescents.

The CPQ was administered to 267 females aged 14–19 years of age. Confirmatory factor analysis (CFA) was used to examine the validity of the two-factor model and a second-order factor model. Pearson correlations were used to evaluate the relationships between the CPQ and a wide range of measures of perfectionism, psychopathology and personality traits.

The study demonstrated internal consistency, construct validity and incremental validity of the CPQ in a sample of female adolescents. The CFA in the present study confirmed the two-factor model of the CPQ with Factor 1 relating to perfectionistic strivings and Factor 2 representing perfectionistic concerns. The second-order two factor model indicated no deterioration in fit.

The two-factor model of the CPQ fits with the theoretical definition of clinical perfectionism where the over-dependence of self-worth on achievement and concern over mistakes are key elements. The CPQ is suitable for use with female adolescents in future research that seeks to better understand the role of perfectionism in the range of mental illnesses that impact youth.

Envy is depicted as motivating destructive desires and actions intended to spoil or destroy that which is envied.

To develop a new valid and reliable measure of malicious envy (C-BRES), which included items representing the cognitive, emotional and behavioural responses empirically associated with this emotion.

A total of 203 adults completed the new 22-item cognitive and behavioural responses to envy scale (C-BRES). Exploratory factor analysis was carried out to test for reliability and internal consistency of the C-BRES. Evidence towards the concurrent construct validity (convergent and discriminant) of the C-BRES was assessed through correlations with the Dispositional envy scale and other measures of psychosocial outcomes empirically linked to envy.

Factor analysis for categorical data identified five dimensions of envy, namely: injustice, hostility, malicious action tendencies, malicious feelings and behavioural responses. The reliability indices of the five factors and the total scale were satisfactory (>0.85). Evidence towards the concurrent construct validity (convergent and discriminant) of the C-BRES is reported. In particular, envy was associated with higher levels of depression, psychoticism, neuroticism, anger and lower levels of self-esteem and quality of life.

All findings support the psychometric adequacy of the C-BRES.

To better understand the maintenance of chronic fatigue syndrome (CFS), a valid and reliable measure of cognitive and behavioural responses to symptoms is required. Such a measure could also assess beliefs and coping behaviours in the context of fatigue in other somatic conditions.

We aimed to establish the psychometric properties of both the Cognitive and Behavioural Responses Questionnaire (CBRQ) and its shortened version (CBRQ-S) in adolescents with CFS.

The full questionnaire was completed by a clinical cohort of adolescents (n = 121) presenting to specialist CFS units in the UK.

Both the CBRQ and CBRQ-S had good internal consistency. The CBRQ scores were strongly associated with depression, anxiety, school and social functioning, but weakly associated with fatigue and physical functioning, providing evidence of validity.

Both the 40-item and the 18-item versions of the CBRQ were found to be reliable and valid in adolescents with CFS. To minimize unnecessary burden, the 18-item version is favoured. Using this assessment tool in future studies, including intervention studies, may help to better target interventions during clinical practice and improve outcomes.

Age of onset is considered central to understanding the course of schizophrenia, yet little is known regarding its association with quality of life in general, and specifically among males and females.

To examine the association between the age of schizophrenia onset and quality of life, in general, and among males and females, using data from a national sample and competing statistical models.

Participants with a diagnosis of schizophrenia (N = 1624) completed the Manchester Short Assessment of Quality of Life (MSA-QoL) and were rated on a parallel measure by their professional caregivers (N = 578). Multiple regression analysis models were computed for self-appraised quality of life, and mixed models with random intercepts were used for caregivers. Six competing models were tested for parsimony for each rating source. Three models without adjustment and three models adjusted for confounding variables. Sensitivity analyses were conducted for males and females separately.

Age of onset was statistically significantly (P <.05) negatively associated with self-appraised and caregiver-appraised quality of life on aggregate and among females. Among males, a significant (P <.01) quadratic effect of onset age on self-appraised quality of life demonstrated a negative association up to onset age of 36.67 years, after which the association was positive.

An earlier age of onset is associated with a better quality of life in schizophrenia which is tentatively explained by social decline. Specific trends in psychiatric symptom severity may account for this association among females while social advantages may account for the particular results found among males.

Cognitive deficits are a well-established feature of bipolar disorders (BD), even during periods of euthymia, but risk factors associated with cognitive deficits in euthymic BD are still poorly understood. We aimed to validate classification criteria for the identification of clinically significant cognitive impairment, based on psychometric properties, to estimate the prevalence of neuropsychological deficits in euthymic BD, and identify risk factors for cognitive deficits using a multivariate approach.

We investigated neuropsychological performance in 476 euthymic patients with BD recruited via the French network of BD expert centres. We used a battery of tests, assessing five domains of cognition. Five criteria for the identification of neuropsychological impairment were tested based on their convergent and concurrent validity. Uni- and multivariate logistic regressions between cognitive impairment and several clinical and demographic variables were performed to identify risk factors for neuropsychological impairment in BD.

One cut-off had satisfactory psychometric properties and yielded a prevalence of 12.4% for cognitive deficits in euthymic BD. Antipsychotics use were associated with the presence of a cognitive deficit.

This is the first study to validate a criterion for clinically significant cognitive impairment in BD. We report a lower prevalence of cognitive impairment than previous studies, which may have overestimated its prevalence. Patients with euthymic BD and cognitive impairment may benefit from cognitive remediation.