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Psychometric testing of two new patient-reported outcome instruments for the evaluation of treatment for hypogonadism.

ABSTRACT: The aim of this study was to perform psychometric testing and estimate minimal important change (MIC) of two new patient-reported outcome (PRO) instruments - Sexual Arousal, Interest and Drive Scale (SAID) and Hypogonadism Energy Diary (HED).New PRO instruments were administered immediately after screening (Time 1, test-retest subset only) and immediately prior to both randomisation (Time 2) and end-point (Time 3) to men participating in a randomised clinical trial comparing the effect of testosterone solution 2% (TS) and placebo on serum total testosterone. Psychometric analyses included reliability, validity and responsiveness. Total scores for both PRO instruments were transformed to a 0-100 scale.Study participants (n = 694) were 80% age ? 65 years, 79% White, with mean baseline testosterone = 202 ng/dl. Clinicians identified 86% subjects as having low sex drive, 86% with low energy and 76% with both symptoms. Reliability analyses for SAID and HED yielded reliability coefficients > 0.70. SAID scores discriminated between men having low sex drive (n = 553) and those who did not (n = 80) (34.5 vs. 42.8, p < 0.001). HED scores discriminated between men having low energy (n = 541) and those who did not (n = 64) (48.9 vs. 60.2, p < 0.001). In the men randomised to TS (vs. placebo), SAID and HED detected effect sizes of 0.61 (vs. 0.39) and 0.68 (vs. 0.48), respectively. MIC estimates for SAID and HED were approximately 10 and 8, respectively.This study provided evidence of the reliability, validity and responsiveness of SAID and HED as measures of sex drive and energy, respectively, making them potentially useful for evaluation of hypogonadal treatment.

SUBMITTER: Hayes RP

PROVIDER: S-EPMC5089588 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

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Psychometric testing of two new patient-reported outcome instruments for the evaluation of treatment for hypogonadism.

Hayes R P RP Ni X X Heiselman D E DE Kinchen K K

International journal of clinical practice 20160613 7

<h4>Aim</h4>The aim of this study was to perform psychometric testing and estimate minimal important change (MIC) of two new patient-reported outcome (PRO) instruments - Sexual Arousal, Interest and Drive Scale (SAID) and Hypogonadism Energy Diary (HED).<h4>Methods</h4>New PRO instruments were administered immediately after screening (Time 1, test-retest subset only) and immediately prior to both randomisation (Time 2) and end-point (Time 3) to men participating in a randomised clinical trial co ...[more]

PMID: 27291501

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Project description:BackgroundFour patient-reported outcome (PRO) instruments are commonly used to assess body image in idiopathic scoliosis (IS): the Quality of Life Profile for Spinal Deformities (QLPSD), SRS-22 Self-Image scale, Spinal Appearance Questionnaire (SAQ), and Trunk Appearance Perception Scale (TAPS). The aim of this study is to compare the psychometric properties of these instruments in patients with IS and report the translational/cultural adaptation of the SAQ to Spanish.MethodsThe four instruments in a Spanish version were administered to 80 patients with IS aged 10 to 40 years old. The sample was stratified according to scoliosis magnitude (less and more than 45º). Analysis was also conducted for age groups. The psychometric properties studied included convergent and divergent construct validity, as well as internal consistency. Convergent validity was evaluated by correlation analysis between the self-image instruments and Cobb angle. Divergent validity was assessed with correlation analysis between PRO scores and SRS-22 dimensions scores such as Function, Pain and Mental Health.ResultsIn the overall sample, each of the PRO instruments demonstrated high internal consistency (QLPSD Body Image, α = 0.80; SRS-22 Self Image, α = 0.78; SAQ, α = 0.89; TAPS, α = 0.87), also both for younger and adult patients subgroups. Correlation with curve magnitude was significant for each of the four scales. However, the correlation was higher for the pictorial scales (SAQ Appearance r = 0.61, TAPS r = -0.62) than for the textual scales (QLPSD-bi r = 0.36, SRS-22 Self-Image scale r = -0.41). In the younger group, correlation between Cobb angle and textual scales (QLPSD-bi and SRS-22 Self-Image Scale) was not significant. Body Image scales showed significant correlations with SRS-22 Pain, Function and Mental Health dimensions.ConclusionsAll four instruments tested have good psychometric properties. Pictorial scales (SAQ Appearance and TAPS) correlated better with the radiological magnitude of the curve and this correlation is independent of age. Unexpectedly, all four scales demonstrated significant correlations with non-body image dimensions and the divergent hypothesis was not confirmed. Globally, pictorial scales showed slightly better construct validity to test body image perception than textual scales.

Project description:BackgroundThe Urgency Numeric Rating Scale (NRS) was developed as a content-valid single-item patient-reported outcome measure to assess severity of bowel urgency. Here, we evaluated the psychometric properties of the Urgency NRS.MethodsData were from a multicenter, randomized, placebo-controlled phase 3 trial in adults with moderately to severely active ulcerative colitis (NCT03518086). Patients completed the Urgency NRS using a daily electronic diary, from which weekly average Urgency NRS scores were calculated. Test-retest reliability, known-groups validity, construct validity, responsiveness, and score interpretation were assessed using the modified Mayo score, Inflammatory Bowel Disease Questionnaire (IBDQ), Patient Global Rating of Severity (PGRS), Patient Global Rating of Change (PGRC), and Geboes score.ResultsThe study sample comprised 1,162 participants (40.2% female). Mean Urgency NRS score was higher (worse) at baseline than at week 12 (6.2 vs. 3.7). Test-retest reliability was strong, with intra-class correlation coefficients of 0.76-0.89. Baseline least-square mean Urgency NRS score was higher for participants with a PGRS score greater than the median (worse symptoms) than for those with a PGRS score less than or equal to the median (7.5 vs. 5.4; p < 0.0001), indicating good known-groups validity. Urgency NRS score was moderately correlated with IBDQ total and domain scores, PGRS, PGRC, and modified Mayo stool frequency, establishing its convergent validity. Correlations were weak for Geboes score and weak to moderate for modified Mayo endoscopic subscore and modified Mayo rectal bleeding, indicating that the Urgency NRS also had discriminant validity. Patients achieving clinical remission, clinical response, IBDQ remission, and PGRS score improvement showed significantly greater improvement on the Urgency NRS (p < 0.0001 for all), demonstrating responsiveness to change. A ≥ 3-point improvement in Urgency NRS score represented a meaningful improvement in bowel urgency and an Urgency NRS score of ≤ 1 point represented a bowel urgency remission threshold that was closely associated with clinical, endoscopic, and histologic remission.ConclusionsThe Urgency NRS is a valid and reliable patient-reported outcome measure that is suitable for evaluating treatment benefits in clinical trials in patients with moderately to severely active ulcerative colitis.

Project description:BACKGROUND:Nonmuscle invasive bladder cancer (NMIBC) is a chronic condition requiring intensive follow-up, repeated endoscopic examinations, tumor resections, and intravesical treatments that can occur every 3 months for life. In this clinical context, patient-reported outcomes (PROs) are a critical concern for patients and their managing clinicians. PROs have enormous potential to be integral to treatment assessment and recommendations for NMIBC; however, current PRO measures are inadequate for NMIBC because they lack key NMIBC-specific symptoms and side effects associated with contemporary treatments. OBJECTIVE:The overarching aim of this study was to develop and evaluate a patient-reported symptom index (SI) for individuals with NMIBC (the NMIBC-SI) that is acceptable to patients; reliable, valid, and responsive to differences between contemporary treatments for NMIBC; and fit for purpose as an endpoint in clinical trials. METHODS:The NMIBC-SI will be evaluated in 2 field tests across a total of 3 years. Field test 1 is a cross-sectional study design involving 225 adult NMIBC patients recruited while undergoing active treatment or those who completed final treatment within the past week. Data collected include patient demographics, clinical features of the tumor, risk category, treatment type, comorbidity, and PROs. Field test 2 is a prospective longitudinal study involving 225 newly diagnosed NMIBC-SI patients. Clinical data and patient-completed questionnaires will be collected at 4 time points during treatment: before tumor resection, 1 week after resection, end-of-induction intravesical therapy, and 1-year follow-up. Standard psychometric tests will be performed to assess the reliability, validity, responsiveness, and clinical utility of the NMIBC-SI. RESULTS:Participant recruitment to field test 1 commenced in February 2017. Recruitment for field test 2 is planned to commence in January 2018. Final results are expected to be published in 2019. The NMIBC-SI will be freely available for use via registration. CONCLUSIONS:This study protocol contains detailed methods that will be used across multiple international sites. Phase 2 in the development of the NMIBC-SI will enable a comprehensive evaluation of its reliability, validity, and responsiveness to ensure that the NMIBC-SI is fit for purpose in clinical research and provides an evidence base for the ongoing improvement of future therapies for NMIBC. TRIAL REGISTRATION:ClinicalTrials.gov NCT03091764; http://clinicaltrials.gov/ct2/showNCT03091764 (Archived by WebCite at http://www.webcitation.org/6umBhQeNX).

Project description:BackgroundThe Near Visual Acuity Questionnaire Presbyopia (NAVQ-P) is a patient-reported outcome (PRO) measure that was developed in a phakic presbyopia population to assess near vision function impacts. The study refined and explored the psychometric properties and score interpretability of the NAVQ-P and additional PRO items assessing near vision correction independence (NVCI), near vision satisfaction (NVS), and near vision correction preference (NVCP).MethodsThis was a psychometric validation study conducted using PRO data collected as part of a Phase IIb clinical trial (CUN8R44 A2202) consisting of 235 randomized adults with presbyopia from the US, Japan, Australia, and Canada. Data collected at baseline, week 2, and months 1, 2, and 3 during the 3-month trial treatment period were included in the analyses to assess item (question) properties, NAVQ-P dimensionality and scoring, reliability, validity, and score interpretation.ResultsItem responses were distributed across the full response scale for most NAVQ-P and additional PRO items. Confirmatory factor analysis supported the pre-defined unidimensional structure and calculation of a NAVQ-P total score as a measure of near vision function. Item deletion informed by item response distributions, dimensionality analyses, item response theory, and previous qualitative findings, including clinical input, supported retention of 14 NAVQ-P items. The 14-item NAVQ-P total score had excellent internal consistency (α = 0.979) and high test-retest reliability (Intraclass Correlation Coefficients > = 0.898). There was good evidence of construct-related validity for all PROs supported by strong correlations with concurrent measures. Excellent results for known-groups validity and ability to detect change analyses were also demonstrated. Anchor-based and distribution-based methods supported interpretation of scores through generation of group-level and within-individual estimates of meaningful change thresholds. A meaningful within-patient change in the range of 8-15-point improvement on the NAVQ-P total score (score range 0-42) was recommended, including a more specific responder definition of 10-point improvement.ConclusionsThe NAVQ-P, NVCI, and NVS are valid and reliable instruments which have the ability to detect change over time. Findings strongly support the use of these measures as outcome assessments in clinical/research studies and in clinical practice in the presbyopia population.

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Psychometric testing of two new patient-reported outcome instruments for the evaluation of treatment for hypogonadism.

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Psychometric testing of two new patient-reported outcome instruments for the evaluation of treatment for hypogonadism.

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