Psychometric Validation of a Novel PRO MEASURE for Assessing Patient-reported Experience of Cognitive Impairment in Schizophrenia (PRECIS)

Abstract Background Cognitive impairment associated with schizophrenia (CIAS) can be a distressing feature that contributes to the burden of the disorder, as well as being a strong predictor of functional impairment. To fully assess the burden to patients living with this illness, there is a need to develop a specific measure of patient-reported outcomes . Methods Following initial development of the Patient-Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) instrument, the domain structure, reliability (inter-item consistency and test–retest reliability), and validity (discriminant validity, divergent, and convergent validity) of the tool were assessed in patients (aged 18–55 years) with CIAS participating in a 12-week, Phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of BI 409306. Healthy control subjects were recruited separately. The PRECIS instrument was completed at baseline, Week 6, Week 9, and Week 12. Results The questionnaire responses of 410 patients with schizophrenia and 88 control subjects were compared. Of the original 35 items included in the draft PRECIS instrument, 11 were eliminated due to poor performance against pre-defined criteria, resulting in a 24-item questionnaire that loaded well onto 5 domains (Attention, Memory, Executive Function, Communication, and Bother). The revised 24-item PRECIS instrument demonstrated adequate discriminant validity between patient and control groups in each of the 5 domains (p<0.0001), convergent validity as shown by a significant correlation between PRECIS scores and the Schizophrenia Cognition Rating Scale (p<0.0001), good internal consistency (Cronbach’s alpha score: 0.942), and adequate test–retest reliability (intra-class correlation coefficient [ICC]: 0.78). A simplified, user-friendly scoring method was identified, which assigned scores to each of the 5 domains using a five-category Likert scale. PRECIS did not correlate with MATRICS or CANTAB composite scores. Conclusions PRECIS is a novel self-completed sensitive instrument designed to measure the subjective experience of cognitive impairment in patients with schizophrenia. The test development process included patient input, perceptions, and feedback, and strong evidence for the validity and reliability of the instrument was demonstrated. The scale provides a patient-based perspective to complement existing objective measures of cognition and serves to define key patient-based endpoints for use in future clinical studies.

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Psychometric Validation of a Novel PRO Measure for Assessing Patient-reported Experience of Cognitive Impairment in Schizophrenia (PRECIS)

10.21203/rs.2.13957/v1 ◽

2019 ◽

Author(s):

Raymond C. Rosen ◽

Jeremiah J. Trudeau ◽

Steven Silverstein ◽

David C. Henderson ◽

Adam Smith ◽

...

Keyword(s):

Cognitive Impairment ◽

Convergent Validity ◽

Discriminant Validity ◽

Psychometric Validation ◽

Controlled Study ◽

Initial Development ◽

Retest Reliability ◽

Control Subjects ◽

Patient Reported ◽

Test Retest Reliability

Abstract Background Cognitive impairment associated with schizophrenia (CIAS) can be a distressing feature that contributes to the burden of the disorder, as well as being a strong predictor of functional impairment. To fully assess the burden to patients living with this illness, there is a need to develop a specific measure of patient-reported outcomes (PROs). Methods Following initial development of the Patient-Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) instrument, the domain structure, reliability (inter-item consistency and test-retest reliability), and validity (discriminant validity, divergent, and convergent validity) of the tool were assessed in patients (aged 18–55 years) with CIAS participating in a 12-week, Phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of BI 409306. Healthy control subjects were recruited separately. The PRECIS instrument was completed at baseline, Week 6, Week 9, and Week 12. Results The questionnaire responses of 410 patients with schizophrenia and 88 control subjects were compared. Of the original 35 items included in the draft PRECIS instrument, 11 were eliminated due to poor performance against pre-defined criteria, resulting in a 24-item questionnaire. In confirmatory factor analysis, the 24 items loaded well onto 5 domains (Attention, Memory, Executive Function, Communication, and Bother). The revised 24-item PRECIS instrument demonstrated adequate discriminant validity between patient and control groups in each of the 5 domains (p<0.0001), convergent validity as shown by a significant correlation between PRECIS scores and the Schizophrenia Cognition Rating Scale (SCoRS; p<0.0001), good internal consistency (Cronbach’s alpha score: 0.942), and adequate test-retest reliability (intra-class correlation coefficient [ICC]: 0.78). A simplified, user-friendly scoring method was identified, which assigned scores to each of the 5 domains using a 5-category Likert scale. Conclusions PRECIS is a novel self-completed sensitive instrument designed to measure the subjective experience of cognitive impairment in patients with schizophrenia. The test development process included patient input, perceptions, and feedback, and strong evidence for the validity and reliability of the instrument was demonstrated. The scale provides a patient-based perspective to complement existing objective measures of cognition and serves to define key patient-based endpoints for use in future clinical studies.

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The Relevance of Insomnia in the Diagnosis of Perinatal Depression: Validation of the Italian Version of the Insomnia Symptom Questionnaire

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph182312507 ◽

2021 ◽

Vol 18 (23) ◽

pp. 12507

Author(s):

Lavinia De Chiara ◽

Cristina Mazza ◽

Eleonora Ricci ◽

Alexia Emilia Koukopoulos ◽

Georgios D. Kotzalidis ◽

...

Keyword(s):

Convergent Validity ◽

Predictive Power ◽

Discriminant Validity ◽

Late Pregnancy ◽

Italian Version ◽

Retest Reliability ◽

Dsm 5 ◽

Insomnia Symptom ◽

Symptom Questionnaire ◽

Test Retest Reliability

Background. Sleep disorders are common in perinatal women and may underlie or trigger anxiety and depression. We aimed to translate and validate and evaluate the psychometric properties of the Italian version of the Insomnia Symptom Questionnaire (ISQ), in a sample of women during late pregnancy and 6-months postpartum according to the DSM-5 criteria. Methods. The ISQ was administered to 292 women prenatally along with other measures of sleep quality, depression, and anxiety, to examine its construct and convergent validity. Women were readministered the ISQ six months postdelivery to assess test–retest reliability. Women were divided into DSM-5 No-Insomnia (N = 253) and Insomnia (N = 39) groups. Results. The insomnia group had received more psychopharmacotherapy, had more psychiatric family history, increased rates of medically assisted reproduction, of past perinatal psychiatric disorders, and scored higher on almost all TEMPS-A dimensions, on the EPDS, HCL-32, PSQI, and on ISQ prenatally and postnatally. ISQ scores correlated with all scales, indicating adequate convergent and discriminant validity; furthermore, it showed antenatal–postnatal test–retest reliability, 97.5% diagnostic accuracy, 79.5% sensitivity, 94.9% specificity, 70.5% positive predictive power, and 92.8% negative predictive power. Conclusions. The ISQ is useful, valid, and reliable for assessing perinatal insomnia in Italian women. The Italian version showed equivalent properties to the original version.

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Cross-Cultural Adaptation and Psychometric Validation of the Dutch Version of the Core Outcome Measures Index for the Neck in Patients Undergoing Surgery for Degenerative Disease of the Cervical Spine

Neurospine ◽

10.14245/ns.2142682.341 ◽

2021 ◽

Vol 18 (4) ◽

pp. 798-805

Author(s):

Pravesh S. Gadjradj ◽

Timothy C. Chin-See-Chong ◽

Daphne Donk ◽

Paul Depauw ◽

Maurits W. van Tulder ◽

...

Keyword(s):

Outcome Measures ◽

Roc Curve ◽

Psychometric Validation ◽

Core Outcome ◽

Dutch Version ◽

Retest Reliability ◽

The Core ◽

Patient Reported ◽

Core Outcome Measures ◽

Test Retest Reliability

Objective: To perform the psychometric validation of the Dutch version of the Core Outcome Measures Index (COMI) for the neck.Methods: A total of 178 patients, who had an indication for surgery due to degenerative cervical spinal disease, were enrolled in the study. They filled in a baseline booklet containing the Dutch version of the COMI-neck, Likert-scales for neck and arm/shoulder pain, the Neck Disability Index (NDI), the EuroQol-5 dimensions (EQ-5D) and the 12-item Short Form health survey (SF-12). Aside from analyzing construct validity using the Spearman correlation test, test-retest reliability, and responsiveness at 3 months were assessed using the intraclass correlation coefficient (ICC) and the receiver-operating characteristic (ROC) curve, respectively.Results: The COMI-neck showed good acceptability with missing data ranging from 0% to 4.5% and some floor/ceiling effects for 3 of the domains at baseline. The COMI-summary score showed good to very good correlation with the EQ5D (ρ = -0.43), the physical component summary of the SF-12 (ρ = -0.47) and the NDI (ρ = 0.73). Individual domains showed correlations of -0.28 to 0.85 with the reference questionnaires. Test-retest reliability analysis showed an ICC of 0.91 with a minimal detectable change of 1.7. Responsiveness analysis of the COMI-neck showed an area under 0.79 under the ROC-curve. The standardized response mean for a good outcome was 1.24 and for a poor outcome 0.37.Conclusion: The current study shows that the Dutch version of the COMI-neck is a valid, reliable and responsive Patient-Reported Outcome Measure, among patients undergoing surgery for degenerative cervical spinal disorders.

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An Indonesian Version of Child Oral Health Impact Profile-Short Form 19 (COHIP-SF19): Assessing Validity and Reliability

Journal of Dentistry Indonesia ◽

10.14693/jdi.v28i1.1247 ◽

2021 ◽

Vol 28 (1) ◽

Author(s):

Siti L. Nuraini ◽

◽

Anton Rahardjo ◽

Diah Ayu Maharan ◽

◽

...

Keyword(s):

Oral Health ◽

Internal Consistency ◽

Convergent Validity ◽

Discriminant Validity ◽

Short Form ◽

Health Impact ◽

P Value ◽

Retest Reliability ◽

Test Retest Reliability ◽

Child Oral Health

Previous surveys have indicated that the majority of Indonesian children have poor oral health. However, scant information is available on children’s oral health related quality of life (OHRQoL). The purpose of this study was to assess reliability as well as discriminant and convergent validity of Child Oral Health Impact Profile-Short Form 19 (COHIP-SF 19) Indonesian version. Methods: The Indonesian version of COHIP-SF 19 was developed according to the guidelines for the cross-cultural adaptation process. The instrument was tested among 529 children between 12 – 15 years old who were randomly selected from six junior high schools in Jakarta. The psychometric testing included internal consistency reliability, test-retest reliability, discriminant validity, and convergent validity. Results: Mean age of the participants was 13.3±0.9 years and 54% of the participants were female. The mean COHIP-SF 19 score was 57.8±8.8 and the median was 58 (range 27 – 75). The internal consistency and test-retest reliability was excellent for COHIP-SF 19 score with Chronbach’s alpha 0.83 and intra-class correlation coefficient 0.81. Children with active decay, untreated caries with pulpal involvement, and gingivitis had significantly lower COHIP-SF 19 scores (p-value ≤ 0.030). Correlation between COHIP-SF 19 score, subscale scores and clinical severity as well as self-rated general or oral health were very low to low (rs = 0.04 – 0.27, p-value ≤ 0.028), after adjustment for children’s age and gender. Conclusions: The Indonesian version of COHIP-SF 19 was successfully developed to be used as an OHRQoL instrument for Indonesian school-age children. The internal consistency, test-retest reliability, discriminant validity, and convergent validity of COHIP-SF 19 Indonesian version were confirmed

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A self-administered, artificial intelligence (AI) platform for cognitive assessment in multiple sclerosis (MS)

10.21203/rs.2.10768/v5 ◽

2020 ◽

Cited By ~ 1

Author(s):

Seyed-Mahdi Khaligh-Razavi ◽

Maryam Sadeghi ◽

Mahdiyeh Khanbagi ◽

Chris Kalafatis ◽

Seyed Massood Nabavi

Keyword(s):

Multiple Sclerosis ◽

Cognitive Impairment ◽

Cognitive Dysfunction ◽

Cognitive Assessment ◽

Cognitive Rehabilitation ◽

Convergent Validity ◽

Strong Association ◽

Therapeutic Interventions ◽

Retest Reliability ◽

Test Retest Reliability

Abstract Background Cognitive impairment is common in patients with multiple sclerosis (MS). Accurate and repeatable measures of cognition have the potential to be used as markers of disease activity. Methods We developed a 5-minute computerized test to measure cognitive dysfunction in patients with MS. The proposed test – named the Integrated Cognitive Assessment (ICA) – is self-administered and language-independent. 91 MS patients and 83 healthy controls (HC) took part in Substudy 1, in which each participant took the ICA test and the Brief International Cognitive Assessment for MS (BICAMS). We assessed ICA’s test-retest reliability, its correlation with BICAMS, its sensitivity to discriminate patients with MS from the HC group, and its accuracy in detecting cognitive dysfunction. In Substudy 2, we recruited 48 MS patients, 38 of which had received an 8-week physical and cognitive rehabilitation programme and 10 MS patients who did not. We examined the association between the level of serum neurofilament light (NfL) in these patients and their ICA scores and Symbol Digit Modalities Test (SDMT) scores pre- and post-rehabilitation. Results The ICA demonstrated excellent test-retest reliability (r=0.94), with no learning bias, and showed a high level of convergent validity with BICAMS. The ICA was sensitive in discriminating the MS patients from the HC group, and demonstrated high accuracy (AUC = 95%) in discriminating cognitively normal from cognitively impaired participants. Additionally, we found a strong association (r=-0.79) between ICA score and the level of NfL in MS patients before and after rehabilitation. Conclusions The ICA has the potential to be used as a digital marker of cognitive impairment and to monitor response to therapeutic interventions. In comparison to standard cognitive tools for MS, the ICA is shorter in duration, does not show a learning bias, and is independent of language.

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Reliability and Structural and Construct Validity of the Functional Strength Measurement in Children Aged 4 to 10 Years

Physical Therapy ◽

10.2522/ptj.20140018 ◽

2016 ◽

Vol 96 (6) ◽

pp. 888-897 ◽

Cited By ~ 13

Author(s):

Wendy F.M. Aertssen ◽

Gillian D. Ferguson ◽

Bouwien C.M. Smits-Engelsman

Keyword(s):

Factor Analysis ◽

Muscle Strength ◽

Construct Validity ◽

Exploratory Factor Analysis ◽

Convergent Validity ◽

Discriminant Validity ◽

Structural Validity ◽

Strength Measurement ◽

Retest Reliability ◽

Test Retest Reliability

Background Adequate muscle strength, power, and endurance are important in children's daily activities and sports. Various instruments have been developed for the assessment of muscle function; each measures different aspects. The Functional Strength Measurement (FSM) was developed to measure performance in activities in which strength is required. Objective The study objective was to establish the test-retest reliability and structural and construct validity of the FSM. Design A cross-sectional descriptive study was conducted. Methods The performance of 474 children with typical development on the FSM was examined. Test-retest reliability (n=47) was calculated with the intraclass correlation coefficient (2.1A) for agreement. Structural validity was examined with exploratory factor analysis, and internal consistency was established with the Cronbach alpha. Construct validity was determined by calculating correlations between FSM scores and scores obtained with a handheld dynamometer (HHD) (n=252) (convergent validity) and between FSM scores and scores on the Movement Assessment Battery for Children–2 (MABC-2) (n=77) (discriminant validity). Results The test-retest reliability of the FSM total score ranged from .91 to .94. The structural validity revealed one dimension, containing all 8 FSM items. The Cronbach alpha was .74. The convergent validity with the HHD ranged from .42 to .74. The discriminant validity with MABC-2 items revealed correlations that were generally lower than .39, and most of the correlations were not significant. Exploratory factor analysis of a combined data set (FSM, HHD, and MABC-2; n=77) revealed 2 factors: muscle strength/power and muscle endurance with an agility component. Limitations Discriminant validity was measured only in children aged 4 to 6 years. Conclusions The FSM, a norm-referenced test for measuring functional strength in children aged 4 to 10 years, has good test-retest reliability and good construct validity.

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Translation, Adaptation And Validation Of The Bulgarian Version Of The SIDAED Questionnaire

Journal of Biomedical and Clinical Research ◽

10.1515/jbcr-2015-0146 ◽

2015 ◽

Vol 8 (1) ◽

pp. 19-25

Author(s):

Rumyana N. Kuzmanova ◽

Irina Z. Stefanova ◽

Irena V. Velcheva ◽

Katerina I. Stambolieva

Keyword(s):

Adverse Effects ◽

Antiepileptic Drugs ◽

Internal Consistency ◽

Discriminant Validity ◽

Retest Reliability ◽

Patient Reported ◽

Convergent Construct Validity ◽

The Difference ◽

Patient’S Outcome ◽

Test Retest Reliability

Summary The aim of the study is the translation, adaptation and validation of Side effects of antiepileptic drugs questionnaire in Bulgarian language (SIDAED-BG) in order to use it for objective monitoring of patients with epilepsy. One hundred and thirty one patients (mean age 40.13±13.37 years) took part in the investigation. The internal consistency and test-retest reliability were tested by Cronbach's α and ICC estimations. The convergent construct validity was evaluated by estimating the correlation of SIDAED-BG with the QOLIE-89 and the discriminant validity - by evaluation of the difference between SIDAED-BG scores and clinical parameters such as type of epilepsy using Kruskal-Wallis ANOVA. The Cronbach's α of the total scale was 0.93. The test-retest reliability was higher and determined the strong positive correlations between the first and second examination. The SIDAED-BG questionnaire showed good internal consistency (Cronbach's alpha ranged from 0.37 to 0.86) and the scores significantly correlated with other questionnaires such as QOLIE-89 and showed a good discriminative validity between groups with different levels of self-assessed adverse effects of antiepileptic drugs. The Bulgarian version of SIDAED is a reliable and valid tool in assessing the patient-reported adverse effects of antiepileptic drugs and their impact on the patient's outcome.

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Validation and reliability testing of the Breast-Q latissimus dorsi questionnaire: cross-cultural adaptation and psychometric properties in a Swedish population

Health and Quality of Life Outcomes ◽

10.1186/s12955-021-01812-x ◽

2021 ◽

Vol 19 (1) ◽

Author(s):

Lynne Kamya ◽

Emma Hansson ◽

Linn Weick ◽

Emma Hansson

Keyword(s):

Correlation Coefficient ◽

Internal Consistency ◽

Latissimus Dorsi ◽

Convergent Validity ◽

Correlation Coefficients ◽

Physical Symptoms ◽

Swedish Population ◽

Retest Reliability ◽

Patient Reported ◽

Test Retest Reliability

Abstract Background The main aim of post-mastectomy breast reconstruction is to improve the patient’s quality of life, which makes high-quality and validated patient-reported outcome measurements essential. None of the established instruments include evaluation of donor-site morbidity, such as impact on upper extremity and back function, when a latissimus dorsi (LD) muscle is used; and BREAST-Q LD questionnaire was therefore recently developed for this purpose. The aim of this study was to translate into Swedish and culturally adapt the BREAST-Q LD questionnaire’s two subscales, appearance and function, and perform a psychometric evaluation of the subscales in a Swedish population of patients. Methods This was a cross-sectional study. The questionnaire was translated according to established guidelines. The questionnaires were sent to all patients operated using an LD flap between 2007 and 2017. Internal consistency was assessed using Cronbach’s α. Inter-item correlations and corrected item-total correlations were calculated using the Pearson’s correlation coefficient. Convergent validity was evaluated by comparing the BREAST-Q LD questionnaire to the Western Ontario Osteoarthritis of the Shoulder Index, using the Spearman correlation coefficient. Test–retest reliability was tested with intraclass correlation coefficients (ICCs), and the coefficient of variation and Bland–Altman plots were drawn. Floor and ceiling effects were calculated. Known-group validation was tested by comparing scores from the patients and from normal controls using the Mann–Whitney U-test and by calculating eta squared effect size. Results The questionnaires were sent to 176 eligible patients and 125 responded (71%). The patients had been operated a mean of 6.6 years ago, and most (92%) had previous radiation. Internal consistency was satisfactory for both subscales. The correlation coefficients between questions were r > 0.30 for all items of both scales. The corrected item-total correlation coefficient ranged from 0.62 to 0.90. As hypothesised, the function scale was correlated with the WOOS “Physical symptoms” subscale. Reliability was adequate according to the ICCs. The ceiling effect threshold for the appearance scale was reached and that for the back scale was almost reached. There were significant differences between patients and controls, in the hypothesised direction. Conclusions The results of this study support a good internal consistency, convergent validity, test–retest reliability and known-group validation for the Swedish BREAST-Q LD questionnaire. However, it may be difficult to discriminate between patients with very mild and those with no symptoms using the appearance scale. Trial registration: ClinicalTrials.Gov identifier NCT04526561.

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Psychometric properties of the perceived stress scale (PSS): measurement invariance between athletes and non-athletes and construct validity

10.7287/peerj.preprints.2268v2 ◽

2016 ◽

Author(s):

Yi-Hsiang Chiu ◽

Frank Jing-Horng Lu ◽

Ju-Han Lin ◽

Chiao-Lin Nien ◽

Ya-Wen Hsu ◽

...

Keyword(s):

Construct Validity ◽

Measurement Invariance ◽

Perceived Stress ◽

Convergent Validity ◽

Student Athletes ◽

Discriminant Validity ◽

Perceived Stress Scale ◽

Retest Reliability ◽

Stress Scale ◽

Test Retest Reliability

Background: Although Perceived Stress Scale (PSS, Cohen, Kamarack, Mermelstein, 1983) has been validated and widely used in many domains, there is still no validation in sports by comparing athletes and non-athletes and examining related psychometric indices. Purpose: The purpose of this study was to examine the measurement invariance of PSS between athletes and non-athletes, and examine construct validity and reliability in the sports contexts. Methods: Study 1 sampled 359 college student-athletes (males = 233; females = 126) and 242 non-athletes (males=124; females=118) and examined factorial structure, measurement invariance and internal consistency. Study 2 sampled 196 student-athletes (males = 139, females = 57, Mage =19.88 yrs, SD = 1.35) and examined discriminant validity and convergent validity of PSS. Study 3 sampled 37 student-athletes to assess test-retest reliability of PSS. Results: Results found that 2-factor PSS-10 fitted the model the best and had appropriate reliability. Also, there was a measurement invariance between athletes and non-athletes; and PSS positively correlated with athletic burnout and life stress but negatively correlated with coping efficacy provided evidence of discriminant validity and convergent validity. Further, the test-retest reliability for PSS subscales was significant (r=.66 and r=.50). Discussion: It is suggested that 2-factor PSS-10 can be a useful tool in assessing perceived stress either in sports or non-sports settings. We suggest future study may use 2-factor PSS-10 in examining the effects of stress on the athletic injury, burnout, and psychiatry disorders.

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