Reliability and Validity of a Novel Cognitive Self-Assessment Tool for Patients with Cancer

2021 ◽  
Author(s):  
Giuliana V Zarrella ◽  
Alice Perez ◽  
Jorg Dietrich ◽  
Michael W Parsons

Abstract Background Subjective cognitive function is an important outcome measure in oncology. The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is a quality of life (QoL) measure that includes indices of physical, emotional, social, and neurologic aspects of disease, but does not measure cognitive function. This study seeks to validate a novel index of cognition derived from the FACT-Br. Methods Patients with heterogeneous cancer diagnoses (N=214) completed neuropsychological evaluation and self-report measures. Nine FACT-Br items regarding cognition were combined to form the FACT-Br-Cognitive Index (CI). Reliability was evaluated by exploratory factor analysis and internal consistency. Concurrent validity was assessed by correlating FACT-Br-CI with the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive-8 scales. Discriminant validity was assessed by correlating FACT-Br-CI with other FACT-Br indices and the Beck Depression and Anxiety Inventories (BDI, BAI). Exploratory analyses evaluated the impact of cognitive performance and disease variables on FACT-Br-CI. Results The FACT-Br-CI consisted of a single factor that demonstrated high internal consistency (α=.867) and strong concurrent validity, correlating strongly with PROMIS-Cognitive-8 scales (r=.675-.782). The relationship between the FACT-Br-CI and other FACT subscales ranged from moderate to strong (r=.372-.601), as did correlations with measures of depression (BDI, r=-.621) and anxiety (BAI, r=-.450). Modest correlations were observed with neuropsychological measures (r’s=.249-.300). Conclusions The FACT-Br-CI is a reliable and valid measure of self-reported cognition. Studies that included the FACT-Br could be retrospectively analyzed to assess subjective cognitive outcomes, enriching the information from prior research. Integration of the FACT-Br-CI in routine clinical care may be an efficient method of monitoring cognition.

2015 ◽  
Vol 37 (2) ◽  
pp. 94-99
Author(s):  
Maria Cristina Lima e Silva ◽  
Tânia Maria da Silva Mendonça ◽  
Carlos Henrique Martins da Silva ◽  
Rogério de Melo Costa Pinto

Background: Mental disorders often impair functioning in several areas of life and lead to unhappiness and suffering that may affect health-related quality of life (HRQoL). Satisfaction with participation is an indicator of HRQoL, and its measurement by patients reflects the impact of disease on their social, emotional and professional life. The Patient-Reported Outcomes Measurement Information System (PROMIS(r)) offers an item bank based on item response theory. This system provides efficient, reliable and valid self-report instruments of satisfaction with participation, a measure that is both scarce and useful in the assessment of mental disorder outcomes.Objective:To cross-culturally adapt the PROMIS(r) satisfaction with participation item bank to Portuguese.Methods:Cross-cultural adaptation followed the Functional Assessment of Chronic Illness Therapy (FACIT) multilingual translation method and was achieved through steps of forward and backward translations, review by bilingual experts (one of them a native of Portugal) and pretesting in a group of 11 adult native Brazilians. Instrument adaptation followed a universal approach to translation, with harmonization across languages.Results: Equivalence of meaning was achieved. As two of the 26 translated items, which asked about leisure and social activities, were not understood by less educated participants, an explanation in parentheses was added to each item, and the problem was solved. All items were appropriate and did not cause embarrassment to the participants.Conclusions: The satisfaction with participation item bank is culturally and linguistically suitable to be used in Brazil. After the pretest is applied in Portugal and in other Portuguese-speaking countries, the same instrument will be ready to be used in multinational studies.


Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Irene Katzan ◽  
Sandra Griffith ◽  
Youran Fan

Background: Functional status is a critically important outcome measure after stroke. The ability to electronically capture this through self-report is increasing. The Patient Reported Outcomes Measurement Information System (PROMIS) uses computer adaptive testing (CAT), which can increase score precision and reduce patient burden. The number of questions depends on the patient’s responses. The objective of this study was to evaluate the performance of the PROMIS physical function scale (PROMIS PF) compared to the validated Stroke Impact Scale 16 (SIS16) in an ambulatory stroke clinic. Methods: Patient-reported PROMIS PF (CAT version) and SIS16 were electronically collected on patients seen in the stroke clinic using the Knowledge Program platform. Patient completion rates were > 70%. Distribution of scores was compared to assess ceiling/floor effects. Internal consistency was assessed by calculating the SEM for PROMIS PF and Cronbach’s alpha for SIS16. Correlations with NIHSS were performed to assess convergent validity. Results: The PROMIS PF and SIS16 were collected on 5,691 patients from Jan 2010 - May 2014. Mean SIS16 score = 81.4 (SD 21.5), mean PROMIS PF score = 42.8 (SD 11.2). The SIS16 had a22% ceiling effect, <1 % ceiling effect was seen with PROMIS PF (Figure). Patients completed 16 SIS16 items and a median of 4 [IQR 4, 5] PROMIS PF items. Cronbach’s alpha for SIS16 = 0.959, SEM for PROMIS PF = 2.3; both values suggest excellent internal consistency. Test-retest correlation was 0.867 for SIS16 and 0.87 for PROMIS PF. Correlations between NIHS and the 2 scales were -0.461 (p<0.001) for PROMIS PF and -0.559 (p<0.0001) for SIS16. Conclusion: The use of the PROMIS system to obtain electronic patient-reported functional status in ambulatory stroke clinic is feasible. PROMIS PF is an option for measurement of physical function in patients with stroke. It had similar test characteristics as the SIS16 but with lower patient burden and no ceiling effect.


2019 ◽  
Vol 67 (5) ◽  
pp. 241-249 ◽  
Author(s):  
Christopher C. Imes ◽  
Eileen R. Chasens

The impact of shift work on sleep and health has been examined in the past, but most studies utilized cross-sectional designs relying on between-subject differences. The purpose this study was to examine the within-subject differences in self-report measures of health and wellness among a group of nurses engaged in rotating shifts. Patient-Reported Outcomes Measurement Information System (PROMIS) measures, collected post-day and post-night shift, were used to assess health, sleep disturbances and sleep-related impairment, fatigue, emotional distress (anger), satisfaction with social roles outside of work, and applied cognitive abilities. Among the sample of 23 White, mostly female (91.3%) nurses, all PROMIS measures were worse indicting lower health and wellness after working night shifts compare to after working day shifts ( p values from .167 to < .001). During both time points of assessment, sleep-related impairment was highly correlated with greater emotional distress, greater fatigue, and worse memory and concentration. Study findings support prior studies that shift work can negatively impact health and wellness.


Author(s):  
Sameer A. Ashaie ◽  
Leora R. Cherney

Purpose Depression assessment is challenging in persons with aphasia given their language impairment. Studies have used both self-report scales and by-proxy measures of depression in persons with aphasia. However, the validity of these measures has been called into question. The aim of this study was to conduct a preliminary investigation into aspects of validity of the community version of the Stroke Aphasia Depression Questionnaire (SADQ-10) and the Center for Epidemiological Studies Depression Scale–Revised (CESD-R). Method Twenty-four participants with chronic aphasia completed the CESD-R, the Patient-Reported Outcomes Measurement Information System Global Mental Health scale (PROMIS GMH), and the Dynamic Visual Assessment of Mood Scales (D-VAMS) while their caregivers completed the SADQ-10. Internal consistency of the CESD-R and the SADQ-10 and the convergent validity of the CESD-R, SADQ-10, PROMIS GMH, and D-VAMS were examined. Results The SADQ-10 and the CESD-R were internally consistent. The CESD-R was moderately correlated with the SADQ-10, PROMIS GMH, and D-VAMS. However, the SADQ-10 was not correlated with the PROMIS GMH and D-VAMS. Conclusions We suggest both the CESD-R and the SADQ-10 be used together to screen for depression in persons with aphasia. Further studies with larger sample sizes need to be conducted to establish validity of other depression screening instruments in person with aphasia.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e23171-e23171
Author(s):  
Madeline B. Matthys ◽  
Andre Dempsey ◽  
Michelle E. Melisko ◽  
Amrita Basu ◽  
Nickolas Dreher ◽  
...  

e23171 Background: NCI PROMIS assesses physical, mental and social health across multiple health conditions. Despite interest in using PROMIS in oncology trials and clinical care, reference values in cancer are not well established. Methods: Electronic intake questionnaires assessing self-reported history and 8 PROMIS domains (depression, anxiety, fatigue, sleep-related impairment (SRI), sleep disturbance, cognitive function, applied cognition and physical function) are sent to all new patients (pts). 2886 pts with self-reported breast cancer completed the questionnaire/consented to research. PROMIS T-Scores were calculated using the Health Measures system. Results: For all domains except depression, cognitive function and applied cognition, pts had clinically meaningful ( > 3 point diff.) worse mean PROMIS scores than US means (50). Compared to stage 0-III, stage IV pts had worse scores for all assessed domains (p < 0.05). Among Stage IV pts < 49, QoL was significantly worse in 7/8 domains (see table). Across all age groups, there were significant differences in mean PROMIS scores for Stage IV pts in anxiety, depression, cognitive function and applied cognition (p < 0.05). Conclusions: PROMIS scores among pts indicate impaired QoL in multiple domains. These scores provide insight into the physical, mental and social health of our pts and can serve as robust estimates for breast cancer trials and clinical care. [Table: see text]


2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii145-ii145
Author(s):  
Giuliana Zarrella ◽  
Alice Perez ◽  
Jorg Dietrich ◽  
Michael Parsons

Abstract INTRODUCTION Subjective cognitive dysfunction is an important outcome measure in neuro-oncology and may provide additional information beyond performance-based neuropsychological testing. The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is a frequently used quality of life (QoL) measure that includes indices of physical, emotional, social, and neurologic aspects of disease, but does not measure cognitive concerns. This study seeks to develop and validate an index of self-reported cognition derived from existing items on the FACT-Br. METHODS 145 patients (Mage=51.08, Medu=15.63) with heterogeneous brain tumor diagnoses completed neuropsychological evaluation including cognitive testing and self-report measures. Nine FACT-Br items regarding cognition were combined to form the Cognitive Index (CI). Reliability of the CI was measured with Cronbach’s alpha. Concurrent validity was assessed by correlating the CI with the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Abilities-8 or PROMIS Cognitive Concerns-8. Discriminant validity was assessed by correlation of the CI with other FACT-Br indices and the Beck Depression and Anxiety Inventories (BDI, BAI). RESULTS Internal consistency within the CI was high (Cronbach’s a 0.864). The CI correlated strongly with the PROMIS-Abilities (r =.680; p&lt; 0.001) and PROMIS-Concerns (r=.780; p&lt; 0.001) indicating high convergent validity. Moderate correlations were observed between the CI and the physical and functional subscales of the FACT (r=.453 and .555), whereas correlations with the social and emotional functioning subscales were weaker (r=.381 and .325). The FACT-Br-CI correlated strongly with BDI (r=-.622) and more weakly with the BAI (r=-.344). Consistent with prior literature, the CI showed modest correlations with neuropsychological measures, including verbal memory encoding (r=.300), verbal fluency (r=.252) and a composite measure of cognition (r=.249; all p’s&lt; .01). CONCLUSIONS The FACT-Br-CI is a reliable and valid measure of self-reported cognition. Studies that include the FACT-Br could be retrospectively analyzed to assess self-reported cognitive outcomes, enriching the information gained from prior research.


F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 1878 ◽  
Author(s):  
Christelle Chrea ◽  
Catherine Acquadro ◽  
Esther F. Afolalu ◽  
Erica Spies ◽  
Thomas Salzberger ◽  
...  

Background. Determining the public health impact of tobacco harm reduction strategies requires the assessment of consumer perception and behavior associated with tobacco and nicotine products (TNPs) with different exposure and risk profiles. In this context, rigorous methods to develop and validate psychometrically sound self-report instruments to measure consumers’ responses to TNPs are needed. Methods. Consistent with best practice guidelines, including the U.S. Food and Drug Administration’s “Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims,” scientifically designed, fit-for-purpose, reliable, and valid instruments are now being applied to tobacco regulatory research. Results. This brief report presents the ABOUT™ Toolbox (Assessment of Behavioral OUtcomes related to Tobacco and nicotine products) initiative. This communication: (1) describes the methodological steps followed for the development and validation of the measurement instruments included in the ABOUT™ Toolbox, (2) presents a summary of the high-priority tobacco-related domains that are currently covered in the ABOUT™ Toolbox (i.e., risk perception, dependence, product experience, health and functioning, and use history), and (3) details how the measurement instruments are made accessible to the scientific community. Conclusions. By making the ABOUT™ Toolbox available to the tobacco research and public health community, we envision a rapidly expanding knowledge base, with the goals of (1) supporting consumer perception and behavior research to allow comparisons across a wide spectrum of TNPs, (2) enabling public health and regulatory communities to make better-informed decisions for future regulation of TNPs, and (3) enhancing surveillance activities associated with the impact of TNPs on population health.


2020 ◽  
Author(s):  
Xinling Zhang ◽  
Lei Yuan ◽  
Yan Zeng ◽  
Zhongqiang Chen ◽  
Weishi Li ◽  
...  

Abstract Study Design: a retrospective study.Summary of Background Data: Long-level spinal instrumented fusion for DLS by intention eliminated spinal motion in an attempt to alleviate pain, improve deformity, and reduce disability. However, this surgery considerably impaired performance of activities of daily living (ADL) due to the resulting stiffness. The lumbar stiffness disability index (LSDI) was a validated measure of the effect of lumbar stiffness on functional activity, however, which might not be fully applicable to elderly Chinese population because of their several special lifestyles.Objective: To evaluate the lumbar stiffness in patients with degenerative lumbar scoliosis (DLS) after long-level fusion by Chinese-LSDI (C-LSDI).Methods: 129 DLS patients underwent long-level (≧4 levels) fusion surgery with at least one-year follow-up were included. The C-LSDI was designed by modifying LSDI and Korean-LSDI (K-LSDI) considering elderly Chinese lifestyles, and the patient-reported outcome questionnaire measuring the impact of lumbar stiffness on functional abilities in elderly Chinese with DLS was assessed for internal consistency and retest repeatability.Results: All patients showed increased lumbar stiffness with significantly improvement in pain and deformity postoperatively, and for items of performing personal hygiene after toileting and getting out of a car, people performed more inconvenient with increasing fixed levels. Compared with LSDI and K-LSDI, the C-LSDI demonstrated high internal consistency (Cronbach’s alpha=0.902) and retest reliability (ICC=0.904) in the elderly Chinese population. Conclusion: This study demonstrated that the C-LSDI questionnaire was a reliable and valid instrument for assessing functional limitations due to lumbar stiffness among elderly Chinese patients with DLS after long-level fusion. Although the effects of stiffness did trend toward greater impacts among patients underwent longer fusions, most patients were satisfied with trade-offs of function and pain relief in exchange for perceived increases in lumbar stiffness.


Author(s):  
Nguyen Thi Hoa ◽  
Anselme Derese ◽  
Jeffrey F. Markuns ◽  
Nguyen Minha Tam ◽  
Wim Peersman

Abstract Aim: To adapt the provider version of the Primary Care Assessment Tool (PCAT) for Vietnam and determine its internal consistency and validity. Background: There is a growing need to measure and explore the impact of various characteristics of health care systems on the quality of primary care. It would provide the best evidence for policy makers if these evaluations come from both the demand and supply sides of the health care sector. Comparatively more researchers have studied primary care quality from the consumer perspective than from the provider’s perspective. This study aims at the latter. Method: Our study translated and adapted the PCAT provider version (PCAT PE) into a Vietnamese version, after which a cross-sectional survey was conducted to examine the feasibility, internal consistency and validity of the Vietnamese PCAT provider version (VN PCAT PE). All general doctors working at 152 commune health centres in Thua Thien Hue province had been selected to participate in the survey. Findings: The VN PCAT PE is an instrument for evaluation of primary care in Vietnam with 116 items comprising six scales representing four core primary care domains, and three additional scales representing three derivative domains. From the translation and cultural adaptation stage, two items were combined, two items were removed and one item was added. Six other items were excluded due to problems in item-total correlations. All items have a low non-response or ‘don’t know/don’t remember’ response rate, and there were no floor or ceiling effects. All scales had a Cronbach’s alpha above 0.80, except for the Coordination scale, which still was above the minimum level of 0.70. Conclusion: The VN PCAT PE demonstrates adequate internal consistency and validity to be used as an effective tool for measuring the quality of primary care in Vietnam from the provider perspective.


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