Psychometric properties of patient reported outcome (PRO) instruments in patients with small cell lung cancer (SCLC) in RESILIENT part 1.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e24027-e24027
Author(s):  
Jaba Kokhreidze ◽  
Veleka Allen ◽  
Cristina Ivanescu ◽  
Xiaopan Valerie Yao ◽  
Bin Zhang ◽  
...  

e24027 Background: The ongoing two-part phase 2/3 RESILIENT study (NCT03088813) is investigating the efficacy and safety of liposomal irinotecan monotherapy in patients with SCLC who have progressed on or after first line platinum-based chemotherapy. This exploratory analysis from RESILIENT part 1 was conducted to confirm the psychometric properties of established PRO instruments that had not previously been validated in patients with SCLC. Methods: Patients completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) Core 30 (C30) and the EORTC QLQ Lung Cancer 13 (LC13) before treatment assignment (baseline), every 6 weeks thereafter, at treatment discontinuation and at the 30-day follow-up visit. Psychometric methods included descriptive statistics (items and scales), correlations (item-to-item and item-to-total), internal consistency (Cronbach’s α), test-retest reliability (intraclass correlation coefficient [ICC], two-way random effects model), construct validity and sensitivity to change. The analysis included patients who received at least one dose of study drug and completed at least one PRO assessment. Results: Thirty patients were enrolled in RESILIENT part 1 and included in the analysis. At baseline, 68% of patients reported ‘not severe’ or ‘mild’ symptoms. Floor effects (i.e. more than 25% of responses of ‘not at all’) were observed for several of the functioning/impact and symptom scales of the EORTC QLQ C30 and LC13. Moderate to strong correlations were found among most questionnaire items within their respective scales. Acceptable evidence for internal consistency and good test-retest reliability were observed. Selected results for the EORTC QLQ LC13, including dyspnea scales, are shown in the Table. The magnitude of correlations among PRO instruments supported evidence for convergent validity in this sample. Conclusions: In RESILIENT part 1, patients experienced low and tolerable symptoms at enrollment, limiting the potential for further improvement. Overall, these PRO instruments had acceptable psychometric properties (e.g. construct validity, reliability and ability to detect change) in this sample. However, these analyses should be repeated in a larger sample using data from RESILIENT part 2. Clinical trial information: NCT03088813. [Table: see text]

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Amin Kordi Yoosefinejad ◽  
Fatemeh Karjalian ◽  
Marzieh Momennasab ◽  
Shahrokh Ezzatzadegan Jahromi

Abstract Background Hemodialysis is considered a major therapeutic method for patients with chronic kidney disease. Pruritus is a common complaint of hemodialysis patients. The 5-D pruritus scale is amongst the most common tools to evaluate several dimensions of itch. Psychometric properties of the 5-D scale have not been evaluated in Persian speaking population with hemodialysis; hence, the objective of this study was to assess reliability and validity of the Persian version of the scale. Methods Ninety hemodialysis patients (men: 50, women: 40, mean age: 54.4 years) participated in this cross-sectional study. The final Persian version of 5-D scale was given to the participants. Tests Compared: One-third of the participants completed the scale twice within 3–7 days apart to evaluate test- retest reliability. Other psychometric properties including internal consistency, absolute reliability, convergent, discriminative and construct validity, floor/ceiling effects were also evaluated. Results The Persian 5-D scale has strong test-retest reliability (ICC= 0.98) and internal consistency (Cronbach’s alpha= 0.99). Standard error of measurement and minimal detectable change were 0.33 and 0.91, respectively. Regarding convergent validity, the scale had moderate correlation with numeric rating scale (r =0.67) and quality of life questionnaire related to itch (r = 0.59). Exploratory factor analysis revealed two factors within the scale. No floor or ceiling effect was found for the scale. Conclusion The Persian version of 5-D the itching scale is a brief instrument with acceptable reliability and validity. Therefore, the scale could be used by experts, nurses, and other health service providers to evaluate pruritus among Persian speaking hemodialysis patients.


2017 ◽  
Vol 32 (2) ◽  
Author(s):  
Shannon Gwin ◽  
Paul Branscum ◽  
E. Laurette Taylor

The purpose of this study was to create a valid and reliable instrument to evaluate theory-basedbeliefs towards physical activity among clergy members. Data were collected from 174 clergy that par-ticipated in a 15-item online and paper-based survey. Psychometric properties of the instrument includedconfirmatory factor analysis (construct validity), and cronbach’s alpha (internal consistency reliability).In addition, the stability (test-retest reliability) of each subscale was evaluated with a sub-sample of 30participants. Results show the instrument was both valid and reliable, and will be useful in future studiestargeting this population. Future implications are discussed.


Author(s):  
Mazen Alqahtani

BACKGROUND: To date the Neck OutcOme Score (NOOS) was not cross-culturally adapted, validated or available in the Arabic language, although it was available in other languages. OBJECTIVE: To translate and cross-culturally adapt the Arabic version of the Neck OutcOme Score (NOOS-Ar) and study its psychometric properties. METHODS: A sample of 146 subjects with chronic neck pain filled in the NOOS-Ar questionnaire to determine the Cronbach’s alpha (α) for internal consistency, test-retest reliability by intraclass correlation coefficients(2,1) [ICC(2,1)], inter-item correlation, measurement error by coefficient of variance and minimal detectable change, ceiling and floor effects, convergent construct validity with visual analog scale (VAS) by Spearman’s rank correlation coefficient (ρ) and factor analysis to calculate and determine its psychometric properties. RESULTS: Excellent internal consistency (Cronbach’s α> 0.9) and test-retest reliability [ICC(2,1)> 0.9] were observed in NOOS-Ar. None of the five subscales of the NOOS-Ar showed a floor or ceiling effect. The coefficient of variance was generally high, but the minimal detectable change was within the acceptable range (< 30%). The ‘everyday activity and pain’ and ‘symptoms’ subscales of the NOOS-Ar, showed a moderate correlation with VAS. CONCLUSION: The NOOS-Ar is highly reliable and has a moderate to good degree of convergent construct validity with VAS with no floor or ceiling effects.


2016 ◽  
Vol 73 (9) ◽  
pp. 811-816 ◽  
Author(s):  
Vlatka Lajnert ◽  
Renata Grzic ◽  
Natasa Radica ◽  
Damir Snjaric ◽  
Stjepan Spalj

Background/Aim. Among numerous sociodental indicators the Oral Impacts on Daily Performance (OIPD) is one of the most broadly applied. The aim of this study was to develop and test psychometric properties of a Croatian version of OIDP scale. Methods. The OIDP instrument was translated from English to Croatian in a forward-backward method. The Croatian version was tested for reliability, construct validity and responsiveness on a sample of 702 participants (255 men), aged 18-86 years. Results. Internal consistency of Croatian version of the OIDP was acceptable (alpha = 0.80) and 69.4% of the examinees had oral impacts relating to one or several performances. The most frequently affected performance was eating (53.7%). The test-retest reliability was high (r = 0.99; 95% CI: 0.97-0.99), the mean difference between the OIDP summary scores in two-week interval was not statistically significant. In construct validity testing there was statistically significant correlation between OIDP and self-assessed general and oral health, somatisation, depression and Oral Health Impact Profile ranging from 0.157 to 0.516. Responsiveness was confirmed by a significant reduction of oral impacts on daily performances in subjects before and after treatment of acute dental pain (p < 0.001). Conclusion. The Croatian OIDP index showed good psychometric properties in terms of construct validity, internal consistency, test-retest reliability and responsiveness confirming its appropriateness for use among Croatian population.


2016 ◽  
Vol 27 (3) ◽  
pp. 364-385
Author(s):  
Thi Loan Dang ◽  
Fu-Chih Lai ◽  
Yen-Kuang Lin ◽  
Kuei-Ru Chou ◽  
Nae-Fang Miao ◽  
...  

The lack of a suitable assessment tool may limit optimal stress management and impair the health-related quality of life of patients undergoing hemodialysis. The purpose of the study was to examine latent constructs and psychometric properties of the Vietnamese Hemodialysis Stressor Scale (HSS-V). In total, 180 patients receiving hemodialysis were recruited. Psychometric properties of the HSS-V, including the construct validity, internal consistency, and test–retest reliability, were tested after the instrument translation. The exploratory factor analysis resulted in a 24-item HSS-V with four extracted factors, which explained 58.32% of the total variance. The construct validity was confirmed by significant negative correlations between scores on the HSS-V and Vietnamese-version Short Form-36. The internal consistency (Cronbach’s α = .82-.91) and test–retest reliability (intra-class correlations coefficient = .91-.94) of the 24-item HSS-V were satisfactory. A simple structure and preliminary acceptable psychometric properties of the HSS-V were established and can serve as a basis for further studies.


Author(s):  
Cheng Chen ◽  
Susanne Weyland ◽  
Julian Fritsch ◽  
Alexander Woll ◽  
Claudia Niessner ◽  
...  

Objective: The purposes of this paper were to (a) develop a new short, theory-driven, version of the physical activity enjoyment scale (PACES-S) using content analysis; and (b) subsequently to measure the psychometric properties (construct validity, internal consistency, test–retest reliability, and concurrent validity) of the PACES-S for adolescents. Methods: Six experts used a four-point Likert scale to assess the content validity of each of the 16 items of the physical activity enjoyment scale according to a provided definition of physical activity enjoyment. Based on the results, exploratory factor analysis was used to analyze survey data from a longitudinal study of 182 individuals (Measure 1 of Study 1: 15.75 ± 3.39 yrs; 56.6% boys, 43.4% girls), and confirmatory factor analysis (Measure 2 of Study 1: 15.69 ± 3.44 yrs; 56.3% boys, 43.7% girls) was used to analyze the survey data from a cross-sectional study of 3219 individuals (Study 2; 15.99 ± 3.10 yrs; 47.8% boys, 52.2% girls) to assess the construct validity of the new measure. To assess the reliability, test–retest reliability was assessed in Study 1 and internal consistency in Study 1 and 2. For the concurrent validity, correlations with self-reported and device-based physical activity behavior were assessed in both studies. Results: Four out of sixteen items were selected for PACES-S. Exploratory factor analysis and confirmatory factor analyses identified and supported its factorial validity (χ2 = 53.62, df = 2, p < 0.001; RMSEA = 0.073; CFI = 0.99; RFI = 0.96; NFI = 0.99; TLI = 0.96; IFI = 0.99). Results showed good test–retest reliability (r = 0.76) and internal consistency (a = 0.82 to 0.88). Regarding concurrent validity, the results showed positive correlations with a physical activity questionnaire (Study 1: r = 0.36), with a physical activity diary (Study 1: r = 0.44), and with accelerometer-recorded data (Study 1: r = 0.32; Study 2: r = 0.21). Conclusions: The results indicate that PACES-S is a reliable and valid instrument that may be particularly useful to measure physical activity enjoyment in large-scale studies. It shows comparable measurement properties as the long version of PACES.


2020 ◽  
pp. 112070002090168 ◽  
Author(s):  
Sophia Stasi ◽  
George Papathanasiou ◽  
Afroditi Diochnou ◽  
Basiliki Polikreti ◽  
Antonios Chalimourdas ◽  
...  

Introduction: This study explored the psychometric properties of the modified Harris Hip Score-Greek version (mHHS-Gr) as a patient-reported outcome (PRO) measure in osteoarthritic hip patients. Methods: Internal consistency, test-retest reliability and reproducibility were evaluated in 90 patients aged >55 years. Construct validity was tested against Greek versions of the Lower Extremity Functional Scale (LEFS-Greek) and WOMAC Index (WOMAC-Gr), and the Timed Up and Go (TUG) and 9-stairs-ascend/descend (9S-A/D) tests. Known-groups validity was examined using TUG score (cut-off 13.5 s) as an estimate variable. Responsiveness was examined before and 4 weeks after direct anterior minimal invasive surgery. Results: Reliability: Internal consistency was moderate (Cronbach’s a = 0.614, p < 0.001). Test-retest reliability was excellent (ICC = 0.881, 95% CI, 0.824–0.920). Reproducibility: Floor and ceiling effects were both 1.1%; measurement error was 3.54 ( p < 0.05); minimal important change was lower than minimal detectable change. Validity: mHHS-Gr correlated strongly with both LEFS-Greek and WOMAC-Gr (Pearson’s r 0.801 and −0.783, respectively; p < 0.001). The questionnaire’s correlations with TUG and 9S-A/D were also significant but moderate (Spearman’s ρ: −0.547 and −0.575, respectively; p < 0.001). Known-groups validity showed that mHHS-Gr scores were significantly higher in participants with TUG < 13.5 seconds than in those with TUG > 13.5 seconds ( p < 0.001). In ROC analysis, the cut-off point of 52.5 yielded sensitivity 81% and specificity 71%. Responsiveness: Standardised response mean and Guyatt’s responsiveness statistic were greater than 0.8. Discussion: mHHS-Gr showed significant moderate to excellent reliability, significant moderate to strong validity properties and excellent responsiveness. Overall, mHHS-Gr could be a reliable and valid PRO measure for assessing patients with osteoarthritis of the hip.


2017 ◽  
Vol 76 (8) ◽  
pp. 1374-1380 ◽  
Author(s):  
Ada Man ◽  
Jeannette K Correa ◽  
Jessica Ziemek ◽  
Robert W Simms ◽  
David T Felson ◽  
...  

ObjectivesWe developed a patient-reported outcome (PRO) instrument to assess the skin-related quality of life in patients with systemic sclerosis (SSc).MethodsParticipants with SSc provided input on skin-related health effects through focus groups. We developed items for scleroderma skin PRO (SSPRO) to encompass these effects. Further consideration from cognitive interviews and an expert panel led to reduction and modification of items. A 22-item SSPRO was field tested. Psychometric analysis included test–retest reliability, internal consistency and exploratory factor analysis (EFA). Construct validity was assessed through correlation with other participant and physician-assessed measures.Results140 participants completed the SSPRO: mean age was 53.4 years, median disease duration was 5 years, 82.1% were female and 32.9% had diffuse cutaneous SSc. EFA supported four factors in SSPRO corresponding to hypothesised constructs: physical effects, physical limitations, emotional effects and social effects. Removal of 4/22 items resulted in acceptable goodness-of-fit statistics. Test–retest reliability (intraclass correlation coefficient=0.61–0.83) was moderate to high and internal consistency (Cronbach's α=0.89–0.96) was high. SSPRO correlated strongly with other participant-reported measures (r=0.59–0.88) suggesting construct validity, and less well with physician-assessed measures (r=0.31–0.40). SSPRO scores were significantly different for each level of participant-reported skin severity, and for limited versus diffuse cutaneous SSc.ConclusionsSSPRO has been developed with extensive patient input and demonstrates evidence for reliability and validity. It is complementary to existing measures of SSc skin involvement with emphasis on the patient's experience. Further research is needed to assess its sensitivity to change.


2021 ◽  
Author(s):  
Marco Monticone ◽  
Geoffrey DOVER ◽  
Myosotis MASSIDDA ◽  
Andrea GIORDANO ◽  
Franco FRANCHIGNONI

Abstract Background. The aim of this study was to translate, culturally adapt and validate an Italian version of the Athlete Fear Avoidance Questionnaire (AFAQ-I).Methods. We conducted a cross-sectional evaluation of the psychometric properties of the AFAQ-I in athletes with musculoskeletal injuries, culturally adapting it in accordance with international standards. Psychometric evaluation included exploratory factor analysis, reliability (internal consistency [Cronbach’s alpha], inter-item correlation, and test–retest reliability [intra-class correlation coefficient]). To examine construct validity, we compared (Spearman rank correlation) the AFAQ-I with a numerical pain rating scale (NPRS), the Pain Catastrophizing Scale (PCS), and the Fear Avoidance Beliefs Questionnaire subscales (Physical Activity, FABQ-PA; and Work, FABQ-W). We evaluated sensitivity to change through the minimum detectable change (MDC).Results. The AFAQ-I was administered to 133 university athletes with musculoskeletal injuries (26 females, mean age 25.3 ± 5 years, mean average pain duration 5.6 ± 8.7 months), and resulted acceptable. Factor analysis revealed a 1-factor 10-item solution (explained variance: 53%). Internal consistency was 0.78; average inter-item correlation 0.27; test–retest reliability ICC(2,1) 0.95. As hypothesized a priori, construct validity showed moderate correlations of the AFAQ-I with NPRS (ρ = 0.42), PCS (ρ = 0.59), FABQ-PA (ρ = 0.40) and FABQ-W (ρ = 0.34). The MDC was 4.42 points.Conclusion. The AFAQ-I is a valid Italian translation of AFAQ and demonstrates acceptable psychometric properties. We can recommend its use for clinical and research purposes.


2019 ◽  
Author(s):  
Leonie Klaufus ◽  
Eva Verlinden ◽  
Marcel van der Wal ◽  
Mia Kösters ◽  
Pim Cuijpers ◽  
...  

Abstract Background Anxiety and depression are common in children and adolescents. These disorders can be detected via self-report screening questionnaires in a non-clinical setting like the school environment. Two short versions of the Revised Child Anxiety and Depression Scale (i.e., RCADS-25 and RCADS-20) seem to be feasible for administering in schools. However, it should be examined whether its promising psychometric properties can be replicated and whether knowledge on remaining psychometric properties can be added. This study evaluates the psychometric properties of the RCADS-25 and RCADS-20 used as screening instruments for anxiety and depression in schoolchildren and adolescents. Methods The RCADS-25 was completed by 69,487 schoolchildren and adolescents age 8 to 18 years. The RCADS-25/RCADS-20 broad anxiety scale (15 items), the RCADS-25 major depressive disorder (MDD) scale (10 items), and the RCADS-20 MDD scale (5 items) were assessed on construct validity (structural validity and hypotheses testing), reliability (internal consistency and test-retest reliability), and criterion validity in conformance with internationally consensus-based COSMIN definitions, taxonomy and quality criteria. Results The RCADS-25/RCADS-20 broad anxiety scale demonstrated a sufficient structural validity (CFI = 0.98, TLI = 0.99, RMSEA = 0.03, SRMR = 0.03), internal consistency (alpha = 0.82), test-retest reliability (ICC = 0.73), criterion validity (AUC = 0.79), and all four hypotheses concerning construct validity were confirmed. The RCADS-25 MDD scale demonstrated a sufficient test-retest reliability (ICC=0.70), and three out of four hypotheses testing construct validity were confirmed, but its structural validity was suspect (CFI = 0.89, TLI = 0.94, RMSEA = 0.09, SRMR = 0.06). The RCADS-20 MDD scale demonstrated a sufficient structural validity (CFI = 0.97, TLI = 0.97, RMSEA = 0.08, SRMR = 0.04) and internal consistency (alpha = 0.72), but two out of four hypotheses concerning construct validity were confirmed, while the test-retest reliability (ICC = 0.60) seemed insufficient. Conclusions The RCADS-25/RCADS-20 broad anxiety scale seems valid and reliable for screening schoolchildren and adolescents, but the RCADS-25 and RCADS-20 MDD scales show shortcomings. An MDD scale of seven items that showed acceptable psychometric properties is recommended.


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