Development and validation of the functional assessment of cancer therapy: Antiangiogenesis (FACT-AntiA).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20527-e20527
Author(s):  
Susan Yount ◽  
Karen Kaiser ◽  
Jennifer L Beaumont ◽  
Kimberly Webster ◽  
Lynne I. Wagner ◽  
...  

e20527 Background: Anti-angiogenesis therapies represent a significant and promising advancement in cancer treatment. Side effects from angiogenesis inhibitors, although generally milder than chemotherapy side effects, have the potential to impact Health-related Quality of Life (HRQOL) and may lead to dose reduction or discontinuation. Currently, there are no patient-reported outcomes (PRO) measures that specifically assess HRQOL related to anti-angiogenesis therapy. This study describes the development and validation of a PRO questionnaire for anti-angiogenesis therapy, the FACT-AntiA. Methods: Scale development included identification of 59 anti-angiogenesis side effects from the literature and clinician and patient input. Patient and clinician ratings of the importance of these side effects led to the development of a 24-item scale. Cognitive interviews with 10 patients confirmed item wording and meaning. To assess psychometric properties of the scale, 132 kidney cancer patients completed the FACT-AntiA and other PRO measures including the Functional Assessment of Cancer Therapy-General (FACT-G), the FACT-Kidney Cancer Symptom Index-19 (FKSI-19), and PROMIS Global Health at 3 time points. Patient responses to the FACT-AntiA were analyzed for internal consistency, test-retest reliability, convergent and discriminant validity, and responsiveness to change in clinical status. Results: FACT-AntiA side-effect subscales scores and total score were found to have good internal consistency reliability (most Cronbach’s alpha > 0.70). Test-retest reliability was greater than 0.70 for most subscales and individual items. All single items (except nosebleeds), subscales, and the total score significantly differentiated between groups defined by level of side effect bother. Conclusions: The number of patients who reported a change in their side effect bother was small so evaluation of FACT-AntiA responsiveness to change requires further study. The FACT-AntiA was developed and validated as a tool to enhance treatment decision-making and side effect management for patients receiving anti-angiogenesis therapies and is a reliable and valid index for evaluation of therapy side effects.

1985 ◽  
Vol 45 (2) ◽  
pp. 401-405 ◽  
Author(s):  
Steven L. Wise

This study describes the development and validation of a new instrument entitled Attitudes Toward Statistics (ATS) to be used in the measurement of attitude change in introductory statistics students. Two ATS subscales are identified: Attitude Toward Course and Attitude Toward the Field, respectively. These subscales were demonstrated to have both high internal consistency and test-retest reliability. It is further shown that each ATS subscale provides distinctly different information about the attitudes of introductory statistics students.


1995 ◽  
Vol 166 (5) ◽  
pp. 650-653 ◽  
Author(s):  
Jennifer C. Day ◽  
Graham Wood ◽  
Mike Dewey ◽  
Richard P. Bentall

BackgroundA study was conducted to validate a comprehensive self-rating scale for measuring side-effects of neuroleptic drugs.MethodThe Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS), which includes ‘red herring’ items, was twice administered to 50 DSM–III–R schizophrenic patients, who were also interviewed using the UKU side-effect rating scale; 50 unmedicated controls also completed the LUNSERS.ResultsThe test-retest reliability of the LUNSERS was good (r = 0.811, P< 0.001) as was its concurrent validity against the UKU (r = 0.828, P< 0.001). Scores correlated with chlorpromazine equivalent doses (r = 0.310, P< 0.02). ROC analysis demonstrated that the scale discriminated between patients and non-medicated controls, who scored differently for real side-effects but not for ‘red herring’ items.ConclusionsThe LUNSERS is an efficient, reliable and valid method of assessing neuroleptic side-effects.


2016 ◽  
Vol 9 (3) ◽  
pp. 138-154 ◽  
Author(s):  
A.S. Sergeeva ◽  
B.A. Kirillov ◽  
A.F. Dzhumagulova

This project involves development and validation of TIPI-RU–Russian adaptation of Ten-Item Personality Inventory by S. Gosling, P. Rentfrow and W. Swann. Main study was made on a sample of 218 (109 male, 109 female) students from one of Saint-Petersburg tech universities (main sample), test-retest study was made on an additional sample of 51 individuals: students and volunteers gathered via snowball method. TIPI-RU is shown to be internally consistent in all its parameters except Openness (which is also true for the original TIPI). Using 5PFQ as a template we have evaluated convergent validity of TIPI-RU and obtained good results for all characteristics. Test-retest validity check has shown decent stability and reproducibility of TIPI-RU results. This work employs novel mathematical approaches to dimensionality reduction and random vector dependence measuring in evaluation of internal consistency, convergent validity and test-retest reliability. The results are significant with p-value lesser than 0.001.


Cephalalgia ◽  
2010 ◽  
Vol 30 (9) ◽  
pp. 1082-1100 ◽  
Author(s):  
Colette Andrée ◽  
Michel Vaillant ◽  
Jessica Barre ◽  
Zaza Katsarava ◽  
Jose Miguel Lainez ◽  
...  

We developed a 103-item self-reporting questionnaire to assess the burden of primary headache disorders on those affected by them, including headache characteristics, associated disability, co-morbidities, disease-management and quality of life. We validated the questionnaire in five languages with 426 participants (131 in UK, 60 in Italy, 107 in Spain, 83 in Germany/Austria, and 45 in France). After a linguistic and a face-content validation, we tested the questionnaire for comprehensibility, internal consistency and test–retest reliability at an interval of one month. In the different countries, response rates were between 73% and 100%. Test–retest reliability varied between –0.27 to 1.0 depending of the nature of the expected agreement. The internal consistency was between 0.69 and 0.91. The EUROLIGHT questionnaire is suitable for evaluating the burden of primary headache disorders, and can be used in English, German, French, Italian and Spanish.


2020 ◽  
Vol 17 (3) ◽  
pp. 332-337
Author(s):  
Jessica K Roydhouse ◽  
Bellinda L King-Kallimanis ◽  
Pourab Roy ◽  
Chana Weinstock ◽  
Danielle Krol ◽  
...  

Background: Patient reports of expected treatment side effects are increasingly collected as part of the assessment of patient experience in clinical trials. A global side effect item that is patient-reported has the potential to inform overall tolerability. Therefore, the aim of this study was to examine the completion and distribution of such a global single-item measure of side effect burden in five cancer clinical trials. Methods: Data from five trials from internal Food and Drug Administration databases that included the Functional Assessment of Cancer Therapy–General single-item measure of overall side effect burden (i.e. impact on degree of bother) were analyzed. Completion rates for the side effect bother item, items adjacent to this item, and two non-adjacent items on the Functional Assessment of Cancer Therapy–General that are related to health-related quality of life were calculated at the baseline assessment and at the 3-month assessment. To evaluate the distribution, the percentage of patients reporting high levels (quite a bit or very much bother) of side effect bother at baseline and 3 months was assessed. Results: Completion rates for all items were at least 80% regardless of time point or trial population. However, in three of the five trials, completion rates for the side effect bother item were lower at baseline compared to adjacent and non-adjacent items. This difference was not observed at 3 months. Up to 9.4% of patients reported high levels of side effect bother at baseline. Conclusion: Patients may enter trials already reporting some bother from side effects. This can make interpretation of results with respect to the investigational agent under study challenging. Patients may skip an item evaluating side effect bother at baseline, suggesting some difficulty with interpretation of what is being asked. Further study of the wording and utility of a baseline side effect bother assessment is warranted.


1978 ◽  
Vol 42 (3) ◽  
pp. 731-738 ◽  
Author(s):  
Rudolf Kalin ◽  
Penelope J. Tilby

Two studies are reported in which a scale measuring sex-role ideology was constructed, validated and cross-validated. Sex-role ideology was conceived as a system of sex-role beliefs forming a dimension with a traditional and a feminist pole. From an initial pool of 82 statements, 30 were selected that best discriminated between criterion groups of traditional and feminist women and that represented the heterogeneous content of sex roles. Half of the items are phrased in a feminist and half in a traditional direction. The scale was then cross-validated with new criterion groups. The internal consistency of the scale was shown through item-total correlations and split-half reliability (median r = .79). The test-retest reliability was .87.


2021 ◽  
Vol 25 (1) ◽  
pp. 9-17
Author(s):  
Teresa Smith ◽  
Alyson Filipa ◽  
Samantha Riveron ◽  
Melissa Strzelinski ◽  
Mark Paterno ◽  
...  

The Dance Functional Outcome Survey (DFOS) is a dance-specific questionnaire developed for use with ballet and modern dancers at all training levels. To date, no study has assessed the psychometric properties of the DFOS in pediatric dancers. The purposes of this study were to determine: 1. the reliability of the DFOS when used with healthy and injured pediatric dancers; 2. the validity of the DFOS com- pared to a well-established generic scale, the Pediatric Quality of Life Inventory Physical Function Scale (PedsQL-PFS); and 3. the sensitivity and responsiveness to change of the DFOS in injured dancers. One hundred and two dancers completed the DFOS twice within 10 days. Intra-class correlation coefficients (ICCs) were used to assess test-retest reliability. In a sample of 148 dancers, construct validity was explored by comparing the DFOS to the PedsQL-PFS using Pearson correlations, and Exploratory Factor Analysis (EFA) and Cronbach's alpha were used for internal consistency analyses. A sub-set of 22 injured dancers was employed to examine responsiveness using repeated measures analysis of variance (p < 0.05). The DFOS demonstrated high test-retest reliability (ICC ≥ 0.90). The DFOS total score, activities of daily living (ADL), and dance technique sub-scores had strong construct validity compared to the PedsQL-PFS (r ≥ 0.79). Cronbach's alpha was high ( α = 0.92), indicating excellent internal consistency. There were significant differences across time in DFOS scores (p < 0.001), demonstrating responsiveness to change. There were no floor or ceiling effects. Thus, the DFOS demonstrates excellent reliability, strong validity, and good responsiveness over time and is a viable tool for assessing function in pediatric dancers.


2007 ◽  
Vol 35 (01) ◽  
pp. 11-20 ◽  
Author(s):  
Sangjae Lee ◽  
Jongbae Park ◽  
Hyangsook Lee ◽  
Kwangho Kim

This study describes development and validation of a questionnaire as an adjunct to Traditional Chinese Medicine diagnosis of Yin-Deficiency Syndrome (Yin-DS). The Yin-Deficiency Questionnaire 1 (Yin-DQ1) consists of 10 items. Seventy-nine healthy volunteers and 44 patients diagnosed with Yin-DS were enrolled for the evaluation of discriminant validity and factorial validity. Another group of 83 healthy volunteers participated for test-retest reliability test. Internal consistency was high in both groups (Cronbach's α = 0.8615). Test-retest reliability (Spearman's rank correlation coefficient) ranged from 0.54 to 0.79 ( p < 0.01). Factor analysis demonstrated that a two factor solution best explained the variance in responses (51.62%). The scores of all items in patients diagnosed with Yin-DS were significantly higher compared with those of healthy volunteers. The data show the internal consistency, test-retest reliability and strong discriminative properties of the Yin-DQ1. Further research determining the optimal cut-off score for Yin-DS and testing its usage as an outcome measure in a clinical trial is needed.


2013 ◽  
Vol 2013 ◽  
pp. 1-10 ◽  
Author(s):  
Misuk Lee ◽  
Na Young Bae ◽  
Minwoo Hwang ◽  
Han Chae

Objective. This study was conducted for development and validation of the Sasang Digestive Function Inventory (SDFI) with type-specific digestive function-related symptoms for identification of Sasang type and pathological pattern.Methods and Materials. We selected questionnaire items for pathophysiological symptoms using internal consistency analysis and examined construct validity using 193 healthy participants. Test-retest reliability with a four-week interval as well as convergent validity was examined using the Nepean Dyspepsia Index-Korean (NDIK), Functional Dyspepsia-Related Quality of Life (FDQOL), Dutch Eating Behavior Questionnaire (DEBQ), and Body Mass Index (BMI).Results. The 21-item SDFI showed satisfactory internal consistency (Cronbach’s alpha = 0.743) and test-retest reliability (r=0.886,P<0.001). Three extracted subscales, SDFI-Digestion, SDFI-Appetite, and SDFI-Eating pattern, explained 56.02% of the total variance. The SDFI showed significant (P<0.001) correlation with total symptom score of NDIK, FDRQOL-Eating status, DEBQ-External Eating scale, and BMI. The SDFI score of the Tae-Eum (50.62±8.05) type was significantly (P<0.001) larger than that of the So-Eum (43.11±11.26) type.Conclusion. Current results demonstrated the reliability and validity of the SDFI and its subscales, which can be utilized as an objective instrument for diagnosis of Sasang types and assessment of the type-specific digestive function.


2020 ◽  
Author(s):  
Aline Hajj ◽  
Pascale Salameh ◽  
Rita Khoury ◽  
Roula Hachem ◽  
Hala Sacre ◽  
...  

Abstract Background: The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) scale is a self-assessment scale validated in routine clinical practice to assess cognitive function in cancer patients. This study aimed to validate the 37-item version of FACT-Cog exploring particularly the psychometric properties of four items related to multitasking that were not previously included in the scoring algorithm and assess its correlates in Lebanese cancer patients.Methods: A cross-sectional study was carried out including 261 patients with breast, colorectal and lung cancers undergoing chemotherapy (Ethics: CEHDF1016). Validity was confirmed using a factor analyses using the principal component analysis technique with a varimax rotation. Analyses of internal consistency, “test-retest" reliability, and convergent validity were also performed. Finally, a multiple linear regression was conducted, using the total cognition scale as a dependent variable.Results: The scale had an appropriate construct validity, and items loaded on subscales with adequate sample adequacy to factor analyses outcomes. The test-retest reliability was appropriate for the total cognition score/all sub-scores except for the FACT-Cog QOL. Moreover, a weak but significant and inverse correlation between the FACT-Cog scores and patient’s pain, fatigue, anxiety and depression. Finally, better cognition functioning was noted with age and in working patients, whereas lower functioning was observed in previous smokers and in patients with ovary/brain metastasis. Conclusions: The 37-item tool is valid and reliable. Questions related to multitasking could be included in the scoring system.


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