ELderly Functional Index (ELFI): Validation of a self-reported measure of functional status in cancer patients.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19126-e19126
Author(s):  
Wee-Kheng Soo ◽  
Madeleine King ◽  
Alun Pope ◽  
Christopher B. Steer ◽  
Bianca Alix Devitt ◽  
...  

e19126 Background: Functional assessment of oncology patients can be challenging and is often not performed, or is undertaken by the clinician with minimal direct input from the patient. The ELderly Functional Index (ELFI) is a 12-item composite measure of self-reported functioning in cancer patients. ELFI is derived from four scales from the European Organisation for Research and Treatment of Cancer (EORTC) health-related quality of life (HRQOL) suite: Physical, Role and Social Functioning, and Mobility. This study validated ELFI in patients attending oncology clinics. Methods: For evaluation of validity and internal consistency, 621 cancer patients (31% aged >70 years) fully self-completed the ELFI, cognitive functioning (CF) and emotional functioning (EF) scales of the EORTC QLQ-C30, ECOG-performance status (ECOG-PS), instrumental activities of daily living (IADL) and Clinical Frailty Scale (CFS). For evaluation of test-retest reliability, 278 participants self-completed ELFI, CF, EF, ECOG-PS and Global Rating of Change one week later. Results: ELFI demonstrated excellent internal consistency (Cronbach alpha 0.93, p< 0.001) and test-retest reliability (intraclass correlation coefficient 0.90, p< 0.001). Hypotheses regarding convergent and discriminant validity were confirmed (multitrait-scaling). ELFI was better than its component scales and other function measures at differentiating between participants with different function and frailty scores (known-groups validity, Table). Exploratory factor analysis provided empirical support to the structural validity of ELFI. Strong correlation was observed between ELFI, function and frailty scores. Conclusions: ELFI is a validated patient-reported outcome measure of functional status. ELFI captures broader dimensions of functioning compared to ECOG-PS or IADL. As a composite measure, ELFI has enhanced statistical efficiency, reducing the sample size required to detect a given effect. ELFI could be used as a clinical trial endpoint to assess the functional domains of HRQOL. [Table: see text]

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Juan Pablo Martinez-Cano ◽  
Daniel Vernaza-Obando ◽  
Julián Chica ◽  
Andrés Mauricio Castro

Abstract Objective The aim of this study was to translate to Spanish the patellofemoral pain and osteoarthritis subscale of the knee injury and osteoarthritis outcome score (KOOS-PF) and validate this Spanish version of a disease-specific patient-reported outcome measure (PROM) for patellofemoral pain. Results The KOOS-PF was translated to Spanish and sixty patients with patellofemoral pain and/or osteoarthritis accepted to complete the questionnaire. 1-week later 58 patients answered the questions again for the test–retest reliability validation and finally 55 patients completed 1-month later for the responsiveness assessment. The Spanish version showed very good internal consistency (Cronbach’s alpha: 0.93) and test–retest reliability (intraclass correlation coefficient: 0.82). Responsiveness was confirmed, showing a strong correlation with the global rating of change (GROC) score (r 0.64). The minimal detectable change was 11.1 points, the minimal important change was 17.2 points, and there were no floor or ceiling effects for the score.


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]


2018 ◽  
Vol 29 (07) ◽  
pp. 609-625 ◽  
Author(s):  
Navshika Chandra ◽  
Kevin Chang ◽  
Arier Lee ◽  
Giriraj S. Shekhawat ◽  
Grant D. Searchfield

AbstractThe effects of treatments on tinnitus have been difficult to quantify. The Tinnitus Functional Index (TFI) has been proposed as a standard questionnaire for measurement of tinnitus treatment outcomes. For a questionnaire to achieve wide acceptance, its psychometric properties need to be confirmed in different populations.To determine if the TFI is a reliable and valid measure of tinnitus, and if its psychometric properties are suitable for use as an outcome measure.A psychometric evaluation of the TFI from secondary data obtained from a cross-sectional clinic survey and a clinical trial undertaken in New Zealand.Confirmatory factor analysis and evaluation of internal consistency reliability were undertaken on a sample of 318 patients with the primary complaint of tinnitus. In a separate sample of 40 research volunteers, test–retest reliability, convergent and divergent validity were evaluated. Both samples consisted of predominantly older Caucasian male patients with tinnitus.The internal structure of the original US TFI was confirmed. The Cronbach’s Alpha and Intraclass correlation coefficients were >0.7 for the TFI overall and each of its subscales, indicating high internal consistency and test–retest reliability. Strong Pearson correlations with the Tinnitus Handicap Questionnaire and tinnitus numerical rating scales indicated excellent convergent validity, and a moderate correlation with the Hearing Handicap Inventory, indicated moderate divergent validity. Evaluation of the clinical trial showed good test–retest reliability and agreement between no-treatment baselines with a smallest detectable change of 4.8 points.The TFI is a reliable and valid measure of tinnitus severity in the population tested and is responsive to treatment-related change. Further research as to the TFI’s responsiveness to treatment is needed across different populations.


2022 ◽  
Author(s):  
Eranthi Weeratunga ◽  
Chandanie Senadheera ◽  
Manjula Hettiarachchi ◽  
Bilesha Perera

Abstract Background: Religious and spiritual support (RSS) is considered a vital method of coping among patients with cancer and cancer survivors. Measuring religion and spiritual support received by cancer patients has very little evidence in Sri Lanka compared to the western countries. It would be affected on cancer care management and speedy recovery process of cancer patients; could be benefited to reduce long-term suffering of patients with cancer. This study aimed to develop and validate a tool to measure religion and spiritual support in patients with cancer. Methods: WHO guidelines were incorporated into the cross-cultural adaptation of the newly developed religious and spiritual support scale (RSSS). Internal consistency for the overall RSSS was investigated using Cronbach’s alpha. Intra-class correlation coefficient (ICC) was used to examine the test-retest reliability of the RSSS for the same sample. Validity was checked using convergent and divergent validity. Principal component analysis (PCA) was performed to test factorial/construct validity.Results: The Sinhalese version of RSSS showed a high internal consistency (Cronbach’s alpha-0.883). The scale revealed favourable test-retest reliability (ICC = 0.981). The overall RSSS score correlated negatively and positively with depressive symptoms (r= - 0.338, p<0.05) and quality of life scores; overall (r=0.421, p<0.001), physical (r=0.340, p<0.05), psychological (r=0.279, p=0.08), social (r=0.373, p<0.05) and environmental quality of life (r=0.429, p<0.001) confirming satisfactory divergent and convergent validity of the Sinhalese version of the RSSS. Factor analysis with PCA extracted two factors explaining 74.47% of the variance.Conclusions: The Sinhalese version of RSSS is a reliable and valid scale to assess the religious and spiritual support of patients with cancer in Sri Lanka.


2016 ◽  
Vol 4 ◽  
pp. 1-7 ◽  
Author(s):  
Margaret E. Ryland ◽  
Tiffany L. Grisbrook ◽  
Fiona M. Wood ◽  
Michael Phillips ◽  
Dale W. Edgar

Abstract Background Lower limb burns can significantly delay recovery of function. Measuring lower limb functional outcomes is challenging in the unique burn patient population and necessitates the use of reliable and valid tools. The aims of this study were to examine the test-retest reliability, sensitivity, and internal consistency of Sections 1 and 3 of the Lower Limb Functional Index-10 (LLFI-10) questionnaire for measuring functional ability in patients with lower limb burns over time. Methods Twenty-nine adult patients who had sustained a lower limb burn injury in the previous 12 months completed the test-retest procedure of the study. In addition, the minimal detectable change (MDC) was calculated for Section 1 and 3 of the LLFI-10. Section 1 is focused on the activity limitations experienced by patients with a lower limb disorder whereas Section 3 involves patients indicating their current percentage of pre-injury duties. Results Section 1 of the LLFI-10 demonstrated excellent test-retest reliability (intra-class correlation coefficient (ICC) 0.98, 95 % CI 0.96–0.99) whilst Section 3 demonstrated high test-retest reliability (ICC 0.88, 95 % CI 0.79–0.94). MDC scores for Sections 1 and 3 were 1.27 points and 30.22 %, respectively. Internal consistency was demonstrated with a significant negative association (rs = −0.83) between Sections 1 and 3 of the LLFI-10 (p &lt; 0.001). Conclusions This study demonstrates that Section 1 and 3 of the LLFI-10 are reliable for measuring functional ability in patients who have sustained lower limb burns in the previous 12 months, and furthermore, Section 1 is sensitive to changes in patient function over time.


2015 ◽  
Vol 8 (1) ◽  
pp. 19-25
Author(s):  
Rumyana N. Kuzmanova ◽  
Irina Z. Stefanova ◽  
Irena V. Velcheva ◽  
Katerina I. Stambolieva

Summary The aim of the study is the translation, adaptation and validation of Side effects of antiepileptic drugs questionnaire in Bulgarian language (SIDAED-BG) in order to use it for objective monitoring of patients with epilepsy. One hundred and thirty one patients (mean age 40.13±13.37 years) took part in the investigation. The internal consistency and test-retest reliability were tested by Cronbach's α and ICC estimations. The convergent construct validity was evaluated by estimating the correlation of SIDAED-BG with the QOLIE-89 and the discriminant validity - by evaluation of the difference between SIDAED-BG scores and clinical parameters such as type of epilepsy using Kruskal-Wallis ANOVA. The Cronbach's α of the total scale was 0.93. The test-retest reliability was higher and determined the strong positive correlations between the first and second examination. The SIDAED-BG questionnaire showed good internal consistency (Cronbach's alpha ranged from 0.37 to 0.86) and the scores significantly correlated with other questionnaires such as QOLIE-89 and showed a good discriminative validity between groups with different levels of self-assessed adverse effects of antiepileptic drugs. The Bulgarian version of SIDAED is a reliable and valid tool in assessing the patient-reported adverse effects of antiepileptic drugs and their impact on the patient's outcome.


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Lynne Kamya ◽  
Emma Hansson ◽  
Linn Weick ◽  
Emma Hansson

Abstract Background The main aim of post-mastectomy breast reconstruction is to improve the patient’s quality of life, which makes high-quality and validated patient-reported outcome measurements essential. None of the established instruments include evaluation of donor-site morbidity, such as impact on upper extremity and back function, when a latissimus dorsi (LD) muscle is used; and BREAST-Q LD questionnaire was therefore recently developed for this purpose. The aim of this study was to translate into Swedish and culturally adapt the BREAST-Q LD questionnaire’s two subscales, appearance and function, and perform a psychometric evaluation of the subscales in a Swedish population of patients. Methods This was a cross-sectional study. The questionnaire was translated according to established guidelines. The questionnaires were sent to all patients operated using an LD flap between 2007 and 2017. Internal consistency was assessed using Cronbach’s α. Inter-item correlations and corrected item-total correlations were calculated using the Pearson’s correlation coefficient. Convergent validity was evaluated by comparing the BREAST-Q LD questionnaire to the Western Ontario Osteoarthritis of the Shoulder Index, using the Spearman correlation coefficient. Test–retest reliability was tested with intraclass correlation coefficients (ICCs), and the coefficient of variation and Bland–Altman plots were drawn. Floor and ceiling effects were calculated. Known-group validation was tested by comparing scores from the patients and from normal controls using the Mann–Whitney U-test and by calculating eta squared effect size. Results The questionnaires were sent to 176 eligible patients and 125 responded (71%). The patients had been operated a mean of 6.6 years ago, and most (92%) had previous radiation. Internal consistency was satisfactory for both subscales. The correlation coefficients between questions were r > 0.30 for all items of both scales. The corrected item-total correlation coefficient ranged from 0.62 to 0.90. As hypothesised, the function scale was correlated with the WOOS “Physical symptoms” subscale. Reliability was adequate according to the ICCs. The ceiling effect threshold for the appearance scale was reached and that for the back scale was almost reached. There were significant differences between patients and controls, in the hypothesised direction. Conclusions The results of this study support a good internal consistency, convergent validity, test–retest reliability and known-group validation for the Swedish BREAST-Q LD questionnaire. However, it may be difficult to discriminate between patients with very mild and those with no symptoms using the appearance scale. Trial registration: ClinicalTrials.Gov identifier NCT04526561.


Author(s):  
Ali H. Alnahdi ◽  
Ali Albarrati

The aim of the current study was to examine the psychometric properties of the upper extremity functional index (UEFI) in patients with chronic obstructive pulmonary disease (COPD). Seventy patients with stable COPD completed the UEFI and St. George Respiratory Questionnaire (SGRQ) and performed lung function tests in the first testing session. They completed the UEFI and the Global Rating of Change Scale in the second session, which was within ten days of the first session. The UEFI floor and ceiling effects, internal consistency, test–retest reliability, measurement error, and construct validity were examined. The UEFI was found to have no floor and ceiling effects. The UEFI was also found to have an excellent internal consistency (Cronbach’s alpha = 0.955) and an excellent test–retest reliability (ICC2,1 = 0.91). Totals of 4.85 points and 11.32 points represent the scale’s standard error of measurement, and a minimal detectable change at 90% confidence was used. The UEFI scores showed a significant correlation with the SGRQ activity domain (r = −0.66, p < 0.001) and differed significantly between participants with severe disease and those with mild disease (p = 0.03). The UEFI had no floor or ceiling issues, an excellent internal consistency, a good test–retest reliability, and an acceptable measurement error. The UEFI also demonstrated evidence supporting its construct validity as a measure of upper extremity-related activity limitations in patients with COPD.


2016 ◽  
Vol 4 (1) ◽  
pp. 241 ◽  
Author(s):  
Yin-Ping Zhang ◽  
Huan-Huan Wei ◽  
Xin-Shuang Zhao ◽  
Yao Zhang ◽  
Ya-Qiong Xu ◽  
...  

Rationale, aims and objectives: The appropriate assessment of a cancer patient’s needs is critical for high quality care services. However, a systematic assessment of an individual patient’s needs fundamental to person-centered healthcare, is rarely practised in China. This study aimed to adapt the Comprehensive Needs Assessment Tool (CNAT) to Chinese cancer patients and to evaluate the psychometric properties of the newly adapted Chinese CNAT.Method: Cross-cultural adaptation of the original CNAT was performed according to published guidelines. A subsequent validation study was conducted with 300 cancer patients in Mainland China. Validity was determined through exploratory factor analysis and the known-group comparison. Reliability was determined using internal consistency and test-retest reliability.Results: The overall CNAT had acceptable internal consistency with Cronbach's alpha coefficient 0.967 for the scale and 0.811~0.958 for subscales. Test-retest reliability by intra-class correlations was 0.877 for the overall scale. Principal component analysis resulted in an 8-factor structure explaining 70.325% of the total variance indicating good construct validity. Known-group validity was supported by its ability to detect significant differences according to sociodemographic and medical characteristics of participants.Conclusions: The newly adapted Chinese CNAT scale possesses adequate validity, test-retest reliability and internal consistency in this population.


Author(s):  
Patorn Piromchai ◽  
Supachat Chaiudomsom ◽  
Pattaramon Wijakkanalan ◽  
Torquil Watt

Abstract Introduction The Thyroid-Related Patient-Reported Outcome (ThyPRO) is a new thyroid-specific quality of life patient-reported outcome measure for benign thyroid disorders. Objective The objective of this study was to investigate the face validity, internal consistency, and test-retest reliability of the Thai version of the ThyPRO (ThyPROth). Methods The translation of the ThyPRO questionnaire was performed using double forward translation, reconciliation, single backward translation, and cognitive debriefing, followed by a panel review. Five thyroid patients evaluated the face validity. The internal consistency and test-retest reliability were evaluated in 30 patients with thyroid diseases. Results The overall validity score was 3.75 (range 0–4). The Cronbach α coefficient ranged from 0.76 to 0.95, with a total coefficient of 0.97 (95% CI 0.962–0.959), indicating excellent internal consistency. The test-retest reliability coefficient ranged from 0.70 to 0.97. All values were 0.70 and above. The total reliability coefficient was 0.86 (95% CI 0.724–0.932), indicating excellent reliability. Conclusion The ThyPROth was found to be valid and to exhibit good internal consistency and test-retest reliability. The questionnaire is ready for implementation in the assessment of health-related quality of life in Thai patients with benign thyroid diseases.


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