Dataset Information

Psychometric validation of the 1-month recall Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFS-QOL).

ABSTRACT:

Background

To evaluate the psychometric characteristics of the 1-month recall Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFS-QOL), including the Revised Activities subscale.

Methods

VENUS I and II were phase III, randomized, double-blind, placebo-controlled trials of ulipristal acetate in women with uterine fibroids (UF) and abnormal uterine bleeding. Women completed the 1-month recall UFS-QOL at baseline and after 12 weeks' treatment. Uterine bleeding was assessed via a daily diary (both studies); the Patient Global Impression of Improvement scale (PGI-I) was completed in VENUS II. Psychometric analyses examined internal consistency reliability and construct validity of the UFS-QOL; confirmatory factor analysis (CFA) compared model fit of the original and Revised Activities subscales. Analyses were conducted separately for VENUS I and II.

Results

One hundred and fifty-seven patients in VENUS I and 429 in VENUS II were included. Changes in mean Symptom Severity and health-related quality of life (HRQoL) scale scores indicated symptom burden reductions and HRQoL improvements. Cronbach's alpha coefficients were high at baseline and after 12 weeks' treatment (all ≥0.76, meeting the >0.70 threshold), demonstrating strong internal consistency reliability. Correlations between UFS-QOL scores and bleeding diary responses (range: -0.35 to -0.63), and UFS-QOL scores and PGI-I responses (range: -0.48 to -0.70), ranged from moderate to strong after 12 weeks' treatment (all p < 0.0001). Patients with absence of bleeding or controlled bleeding after 12 weeks' treatment scored significantly better (p < 0.001) on each UFS-QOL scale than patients not achieving those end points, supporting construct validity. CFA confirmed model fit for the Revised Activities subscale.

Conclusions

The 1-month recall UFS-QOL, including the Revised Activities subscale, is a valid, reliable measure to assess UF symptoms and their impact on HRQoL.

Trial registration

ClinicalTrials.gov, NCT02147197 . Registered May 26, 2014; retrospectively registered. ClinicalTrials.gov, NCT02147158 . Registered May 26, 2014; retrospectively registered.

SUBMITTER: Coyne KS

PROVIDER: S-EPMC6708009 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Publications

Psychometric validation of the 1-month recall Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFS-QOL).

Coyne Karin S KS Harrington Amanda A Currie Brooke M BM Chen Jun J Gillard Patrick P Spies James B JB

Journal of patient-reported outcomes 20190823 1

<h4>Background</h4>To evaluate the psychometric characteristics of the 1-month recall Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFS-QOL), including the Revised Activities subscale.<h4>Methods</h4>VENUS I and II were phase III, randomized, double-blind, placebo-controlled trials of ulipristal acetate in women with uterine fibroids (UF) and abnormal uterine bleeding. Women completed the 1-month recall UFS-QOL at baseline and after 12 weeks' treatment. Uterine bleedi ...[more]

PMID: 31444600

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Project description:ObjectiveUterine fibroids can cause a variety of symptoms in women, from heavy menstrual bleeding and dysmenorrhea to bulk symptoms. The Uterine Fibroid Symptom and health-related Quality Of Life questionnaire (UFS-QOL) is a patient-reported outcome measure developed for assessing fibroid-related symptoms in a standardised way. Our aim was to translate and validate the UFS-QOL in Dutch.DesignValidation study.SettingPatients were recruited by a gynaecologist at the outpatient clinic.ParticipantsWomen with uterine fibroids.MethodsThe UFS-QOL was translated into Dutch (UFS-QOL NL) and validated through testing construct validity (comprising of structural validity and hypotheses testing), reliability, responsiveness and interpretability, assessing floor and ceiling effects and minimal important change. An option to answer 'not applicable' was added to the translated questionnaire.Results191 women with uterine fibroids completed the UFS-QOL NL at baseline, after 2 weeks and after 3 months. The questionnaire retained the same factor structure after translation (Comparative Fit Index 0.94-0.95; Tucker-Lewis fit Index 0.93-0.95; Root Mean Square Error of Approximation 0.10-0.11) and correlations to other questionnaires (RAND 36, Hospital Anxiety and Depression Scale and Golombok Rust Inventory of Sexual Satisfaction) were generally moderate, as hypothesised (Pearson's r 0.3-0.7). We found a sufficient reliability with intraclass correlation coefficients of approximately 0.8-0.9 for all subscales. Responsiveness was sufficient when testing hypotheses comparing women who had surgery with those who did not. Cronbach's alpha was higher than 0.7 for all subscales, indicating sufficient internal consistency and there were no concerns about floor or ceiling effects. Minimal important change could not be calculated due to low correlation between the different subscales and the anchor question.ConclusionsThe results support the measurement properties of the Dutch UFS-QOL for assessing fibroid-related symptoms and health-related quality of life in Dutch women with uterine fibroids.

Project description:BackgroundThe main aim in the treatment of symptomatic fibroids by various modalities including uterine fibroid embolisation (UFE) is to alleviate symptoms and ultimately improve the quality of life. The efficacy of this modality of treatment in Black African women with significant fibroid burden and large uterine volumes is not clear. The main objective of the study was to examine potential changes in symptom severity among Black African patients 1 year following UFE for symptomatic uterine fibroids in a resource-constrained setting, rated using a validated questionnaire (UFS-QOL). Secondary outcomes examined were changes in quality of life and potential associations with age, parity, uterine volume and fibroid number prior to UFE. Additional interventions after UFE were also recorded.MethodsA prospective before and after study of Black African patients undergoing UFE was undertaken. Participants underwent pelvic MR imaging prior to UFE and completed the UFS-QOL, a validated condition-specific questionnaire at baseline and at 1 year. Ninety five participants were recruited and data from 80 completing 1 year of follow up were available for analysis of changes in the symptom severity scores.ResultsThe mean reduction in symptom severity score was 29.6 [95% CI 23.6 to 35.6, P < 0.001] and the mean improvement in HRQOL score was 35.7 [95% CI 28.4 to 42.9, P < 0.001]. A greater number of fibroids identified prior to UFE was associated with a more substantial improvement in symptom severity score (rs = 0.28, n = 80, P = 0.013) and participants of higher parity reported a greater improvement in HRQOL score (r = 0.336, P = 0.002). Major and minor surgical interventions were needed in 5 (6.3%) and 10 (12.5%) participants respectively.ConclusionsUFE is associated with clinically useful and statistically significant symptom relief in Black African patients. Symptom improvement following UFE is not compromised by a large fibroid burden and the rate of subsequent intervention is within an acceptable range. UFE is a safe alternative and efforts are needed to widen access to this non-surgical treatment modality.

Project description:INTRODUCTION:Oropharyngeal dysphagia (OD) is a disorder that can have devastating and long lasting effects on a person's medical, mental and psychosocial well-being, thus negatively impacting quality of life. There is currently no validated dysphagia-specific quality of life instrument in Norway. This project aims to evaluate the psychometric properties of the culturally adapted Norwegian version of SWAL-QOL (Nor-SWAL-QOL). METHODS:The original SWAL-QOL was translated into Norwegian according the international translation guidelines. A group of 102 persons with OD and a group of 123 healthy controls were recruited to assess the validity and reliability of the Nor-SWAL-QOL. Correlation analysis of the Nor-SWAL-QOL and the Short Form 36 (SF-36) and correlation analysis of OD group and control group Nor-SWAL-QOL subscale scores were computed to determine convergent, discriminant, and known-groups validity which help comprise construct validity. Internal consistency, test-retest reliability and intraclass correlation coefficient (ICC) were computed for reliability. RESULTS:Convergent and discriminant validity was demonstrated between Nor-SWAL-QOL subscales and SF-36 domains, and distinguished between persons with and those without oropharyngeal dysphagia on all subscales and on the symptom frequency battery (p < 0.001). Additionally, the Nor-SWAL-QOL differentiated between symptom severity levels within the OD group; those requiring food and liquid modifications and those who are tube fed and not tube fed. Nor-SWAL-QOL showed good reliability with adequate internal consistency (Cronbach's α ≥0.70), test-retest reliability (Spearman's rho values 0.68-0.90) and ICC values (0.67-0.89) for all subscales and for the symptom frequency battery. CONCLUSION:Access to valid and reliable dysphagia-specific QoL outcome measures for health care practitioners, dysphagia clinicians and researchers is necessary for comprehensive assessment and treatment outcome measures. The Nor-SWAL-QOL exhibits sufficient psychometric properties for implementation in the Norwegian population.

Project description:BackgroundEosinophilic esophagitis (EoE) is characterized by high levels of eosinophils in the esophageal mucosa. Patients with the disease present with a range of symptoms, including dysphagia (difficulty swallowing). The aim of this analysis was to assess the psychometric properties of the Dysphagia Symptom Questionnaire (DSQ), a patient-reported outcome (PRO) measure of dysphagia associated with EoE. Psychometric properties of the DSQ were assessed using data collected from a 12-week, phase 2, multicenter, randomized, double-blind, placebo-controlled trial of budesonide oral suspension in adolescents and adults (11-40 years old) with EoE.ResultsThe study population comprised 93 patients with EoE; 94.6% of whom were white, 68.8% were male and the mean age (standard deviation) was 21.6 (7.7) years. Patients had been diagnosed with EoE for a mean of 37.6 months before study initiation. The DSQ was feasible to implement with few item-level data missing at baseline. Item discrimination was high, with floor and ceiling effects below the predefined threshold (≤9%). Higher DSQ scores corresponded with presence and increased severity of dysphagia, indicative of strong item discrimination among patients at baseline (threshold >50%). The DSQ was able to detect changes in symptoms over time and produced similar outcomes to those from physician- and other patient-rated measures, supportive of construct validity. The DSQ had strong test-retest reliability (intraclass correlation coefficient, r = 0.82); and was also responsive to disease-level changes, with higher DSQ scores corresponding to increased esophageal eosinophilic burden. Lastly, the percentage changes in the minimal clinically important difference and clinically important difference in DSQ score were estimated at -27.4% and -55.4%, respectively.ConclusionsThese analyses support the DSQ as a valid and reliable measure of dysphagia in patients with EoE. Changes in DSQ scores suggest a level of agreement between clinician, patient and histologic response. The DSQ should therefore be considered a viable PRO measure of dysphagia for use in future therapeutic studies of EoE.

Dataset Information

Psychometric validation of the 1-month recall Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFS-QOL).

Background

Methods

Results

Conclusions

Trial registration

Publications

Psychometric validation of the 1-month recall Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFS-QOL).

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