Dataset Information

Development and Validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ).

ABSTRACT:

Background and objective

Chronic insomnia has major consequences for daytime functioning, yet no fully validated patient-reported outcome instrument for once-daily assessments is available to measure these consequences. This study describes the development and psychometric evaluation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ).

Methods

The Daytime Insomnia Symptom Scale (DISS), an existing 20-item instrument for assessing daytime functioning, was modified to give an 18-item version of the IDSIQ (IDSIQ-18) based on iterative qualitative interviews with 54 subjects with insomnia and expert input. The construct validity and other psychometric properties of the IDSIQ-18 were analyzed based on an interventional study (NCT03056053) in which subjects with insomnia received zolpidem (5 or 10 mg) daily for 2 weeks and an observational study among subjects with no diagnosis of insomnia (good sleepers). Participants in both studies completed the IDSIQ-18 daily for 2 weeks. Exit interviews were conducted with a sample of subjects who completed the interventional study to elicit concepts defining the experience of insomnia, to assess understanding of the response scales, and to determine meaningful change thresholds. Exploratory factor analysis and Rasch analysis were conducted to further assess the structure and latent model for the scoring of the final IDSIQ instrument. Further psychometric evaluation of the final IDSIQ was then conducted.

Results

Subjects in both the interventional study (N = 114) and observational study (N = 103) were predominantly female (65% for subjects with insomnia and 60% for good sleepers). Mean age was 51 years for subjects with insomnia and 45 years for good sleepers. Subjects in the exit interviews (N = 41) demonstrated a good understanding of the IDSIQ-18 response scales. Day 1 mean scores were higher (worse) in subjects with insomnia compared with good sleepers. Based on inter-item correlation, exploratory factor, and Rasch analyses and review of the qualitative data, four items were removed. This yielded the final IDSIQ, with 14 items comprising three domains: Alert/Cognition, Mood, and Sleepiness. The domain structure was determined in a confirmatory factor analysis. Evidence of internal consistency reliability was strong: day 1 Cronbach's alpha was 0.917 for IDSIQ total score and 0.806-0.918 for the domains. Test-retest reliability, assessed for subjects with insomnia with no change on the Patient Global Assessment of Disease Severity scale between day 1 and day 8, was also good (intra-class correlation coefficient 0.856-0.911). Meaningful change thresholds derived for this sample using anchor-based approaches were 20 for IDSIQ total score, 9 for the Alert/Cognition domain, 4 for the Mood domain, and 4 for the Sleepiness domain.

Conclusions

These studies, which closely followed Food and Drug Administration Guidance for Industry on patient-reported outcome measures, support use of the IDSIQ as a fit-for-purpose measure for deriving valid and reliable endpoints in insomnia clinical research trials and real-world studies.

SUBMITTER: Hudgens S

PROVIDER: S-EPMC7884372 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Publications

Development and Validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ).

Hudgens Stacie S Phillips-Beyer Andrea A Newton Louise L Seboek Kinter Dalma D Benes Heike H

The patient 20201101 2

<h4>Background and objective</h4>Chronic insomnia has major consequences for daytime functioning, yet no fully validated patient-reported outcome instrument for once-daily assessments is available to measure these consequences. This study describes the development and psychometric evaluation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ).<h4>Methods</h4>The Daytime Insomnia Symptom Scale (DISS), an existing 20-item instrument for assessing daytime functioning, was modified to ...[more]

PMID: 33131027

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Project description:BackgroundThe Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a new validated 14-item patient-reported outcome (PRO) instrument for evaluating daytime functioning in people with insomnia. It comprises three domains: Alert/Cognition, Mood, and Sleepiness.ObjectiveThe aim of this analysis was to estimate the minimum within-patient change for IDSIQ scores that an adult patient with insomnia would consider meaningful.MethodsData were from a randomized, double-blind, placebo-controlled, phase III clinical trial of daridorexant in adults with insomnia. Subjects completed the IDSIQ daily in the evening, with a recall period of 'today', throughout the 3-month double-blind treatment period. Scores were calculated as a weekly average. Each IDSIQ item was scored on an 11-point numeric rating scale ranging from 0 (not at all/none at all) to 10 (very/a lot), with a higher score indicating a greater severity or impact. PRO measures with correlation coefficients ≥0.30 were included in a subsequent anchor-based analysis. For the IDSIQ total score and each IDSIQ domain, meaningful within-patient change was estimated as the minimum score change patients would consider meaningful in an anchor-based analysis using data from PRO instruments capturing daytime and night-time insomnia symptoms (the Insomnia Severity Index [four items, each scored 0-4, with a higher score indicating greater symptom severity; assessed at screening, baseline, month 1 and month 3], Patient Global Assessment of Disease Severity [6-point scale from 'none' to 'very severe'; assessed weekly], Patient Global Impression of Severity [4-point scale from 'none' to 'severe'; assessed weekly], and Patient Global Impression of Change [7-point scale from 'very much better' to 'very much worse'; assessed weekly for night-time and daytime symptoms separately]). A supplemental distribution-based analysis was also conducted to support the anchor-based analysis.ResultsThe analysis included 930 subjects aged 18-88 years. Spearman correlation coefficients for the relationships between score changes/ratings for anchors and the IDSIQ (0.36-0.44 at month 1, 0.45-0.57 at month 3) were all above the prespecified threshold of 0.30. Mean IDSIQ score changes at months 1 and 3 based on the different anchors supported meaningful within-patient change estimates starting at 17 points for the IDSIQ total score, 9 points for the Alert/Cognition domain, and 4 points for the Mood and Sleepiness domains.ConclusionThis analysis demonstrates the meaningful within-patient change for the IDSIQ total score and domain scores, that the instrument is sensitive to changes in the patient experience of insomnia, and that it can be used in clinical trials to evaluate changes in daytime functioning.Clinical trials registrationNCT03545191 (4 June 2018).

Project description:Introduction"Dizziness" is a common complaint in clinical practice that can occur with anyone. However, since the symptom is caused by a wide range of disorders, a general clinician usually faces some difficulty to detect the cause.ObjectiveThis study aimed to formulate and validate a simple instrument that can be used to screen and predict the most likely cause of dizziness in Thai outpatients.MethodsThis study was divided into two phases. Phase I included 41 patients diagnosed with common causes of dizziness to determine the algorithm and construct the "structural algorithm questionnaire version 1". In addition, to test and retest its content validity and reliability until the instrument had an acceptable level of both. Phase II of the study pertained to evaluating its accuracy in clinical trials, 150 patients with dizziness had a face-to-face interview while they were waiting for their medical appointment.ResultsThe degree of agreement between the algorithm results and clinical diagnoses was within an acceptable level (κ = 0.69). Therefore, this algorithm was used to construct the structural algorithm questionnaire version 1. The content validity of the structural algorithm questionnaire version 1 evaluated by seven experts. The content validity index values of the questionnaire ranged from 0.71 to 1.0. The Cohen's kappa coefficient (κ) of intra-rater reliability of the structural algorithm questionnaire version 1 was 0.71. In clinical trials, 150 patients with dizziness had a face-to-face interview while they were waiting for their appointment. The overall agreement between their questionnaire responses and final diagnoses by specialists showed a moderate degree of clinical accuracy (κ = 0.55).ConclusionsThe structural algorithm questionnaire version 1 had a well-developed design and acceptable quality pertaining to both validity and reliability. It might be used to differentiate the cause of dizziness between vestibular and non-vestibular disorders, especially of outpatients with dizziness symptoms.

Project description:BackgroundValid and reliable instruments measuring musculoskeletal symptoms prevalence and their impacts in the adolescent population are scarce. The Extended Nordic Musculoskeletal Questionnaire (NMQ-E) is a reliable instrument that measures the prevalence, severity and impact of musculoskeletal symptoms. The purpose of this study was: (1) to develop a musculoskeletal symptom screening tool for younger populations derived from the NMQ-E and NMQ French versions and (2) to assess the validity and reliability of the adapted version of the instrument.MethodsBased on the results of a translated (French) and adapted NMQ-E administered to 61 adolescents, a final 27-item dichotomous questionnaire was developed. The questionnaire measured the 6-month prevalence of musculoskeletal symptoms and the impact of these symptoms on school attendance as well as on sports and leisure activity participation. Among the adolescents who agreed to participate, thirty-nine (mean age: 13.7 ± 1.8) formed the reliability cohort and thirty-four (mean age: 14.2 ± 2.3) formed the criterion validity cohort. Reliability was measured by test-retest with a mean time interval of 28 hours. Criterion validity was assessed by comparing the answers to the questionnaires to the participants' clinical records. Statistical tests used were proportions of observed agreement (Po) and the Cohen kappa statistic (k).ResultsThe mean Po for the test-retest was 0.92 for the 6-month symptom prevalence items, 0.99 for the impact of symptoms on school items and 0.96 for the impact on sports and leisure activities items. Kappa values for the reliability assessment ranged between 0.57 and 1.00 for the 27 dichotomous variables. The criterion validity kappa obtained for the agreement between participants' clinical records and questionnaires was k = 0.76.ConclusionsKappa values for the reliability and the criterion validity are of moderate to perfect agreement beyond chance, indicating that there are only minor variations between tests, and good agreement between questionnaire items and clinical records. These results indicate that the adapted version of the NMQ-E is an appropriate self-administered musculoskeletal symptom screening tool for the adolescent population. Items related to the impacts of symptoms would benefit from additional validation using school and sport attendance records.

Project description:UnlabelledTreatment of polycystic liver disease (PLD) focuses on symptom improvement. Generic questionnaires lack sensitivity to capture PLD-related symptoms, a prerequisite to determine effectiveness of therapy. We developed and validated a disease-specific questionnaire that assesses symptoms in PLD (PLD-Q). We identified 16 PLD-related symptoms (total score 0-100 points) by literature review and interviews with patients and clinicians. The developed PLD-Q was validated in Dutch (n = 200) and United States (US; n = 203) PLD patients. We assessed the correlation of PLD-Q total score with European Organization for Research and Treatment of Cancer (EORTC) symptom scale, global health visual analogue scale (VAS) of EQ-5D, and liver volume. To test discriminative validity, we compared PLD-Q total scores of patients with different PLD severity stages (Gigot classification) and PLD-Q total scores of PLD patients with general controls and polycystic kidney disease patients without PLD. Reproducibility was tested by comparing original test scores with 2-week retest scores. In total, 167 Dutch and 124 US patients returned the questionnaire. Correlation between PLD-Q total score and EORTC symptom scale (The Netherlands [NL], r = 0.788; US, r = 0.811) and global health VAS (NL, r = -0.517; US, r = -0.593) was good. There was no correlation of PLD-Q total score with liver volume (NL, r = 0.138; P = 0.236; US, r = 0.254; P = 0.052). Gigot type III individuals scored numerically higher than type II patients (NL, 46 vs. 40; P = 0.089; US, 48 vs. 36; P = 0.055). PLD patients scored higher on the PLD-Q total score than general controls (NL, 42 vs. 17; US, 40 vs. 13 points) and polycystic kidney disease patients without PLD (22 points). Reproducibility of PLD-Q was excellent (NL, r = 0.94; US, 0.96).ConclusionPLD-Q is a valid, reproducible, and sensitive disease-specific questionnaire that can be used to assess PLD-related symptoms in clinical care and future research. (Hepatology 2016;64:151-160).

Dataset Information

Development and Validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ).

Background and objective

Methods

Results

Conclusions

Publications

Development and Validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ).

Similar Datasets

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