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BC-PROM: validation of a patient-reported outcomes measure for patients with breast cancer.

ABSTRACT: Key issues of treatment for patients with breast cancer such as patient satisfaction with treatments, compliance, and some side effects are essential for evaluating quality of life by patient-reported outcomes in clinical trials. The study aimed to develop and evaluate a specific patient-reported measure which included physical, psychological, social, and therapeutic domain for assessing the survival of patients with breast cancer.The pool of items was drafted after a theoretical revision and cognitive interviews with women with breast cancer. The draft scale was formed after the adjustment of the items and dimensions, and the selected items were submitted to expert's judgments. Five statistical methods were used to select these items by 2 validation samples. The final scale was administered to a sample of 417 patients from 8 hospitals and 135 controls for reliability, validity, and responsive analyses.The final BC-PROM consisted of 52 items, 13 subdomains, and 4 domains, being developed after preexamination and formal examination. Cronbach alpha coefficient was 0.902 and 0.712 for the full scale and therapeutic domain. The structural validity results showed that the multidimensional measurement of the scale fulfilled expectations. Differences in the BC-PROM mean scores were significant between cancer patients and healthy participants in 13 subdomains (P?

SUBMITTER: Hu X

PROVIDER: S-EPMC5413279 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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BC-PROM: validation of a patient-reported outcomes measure for patients with breast cancer.

Hu Xiaojuan X Zhang Chunsen C Zhang Yanbo Y

Medicine 20170401 17

Key issues of treatment for patients with breast cancer such as patient satisfaction with treatments, compliance, and some side effects are essential for evaluating quality of life by patient-reported outcomes in clinical trials. The study aimed to develop and evaluate a specific patient-reported measure which included physical, psychological, social, and therapeutic domain for assessing the survival of patients with breast cancer.The pool of items was drafted after a theoretical revision and co ...[more]

PMID: 28445314

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Project description:Due to a lack of an appropriate disease-specific patient-reported outcome (PRO) instrument for chronic heart failure including its social support and treatment aspects in China, this study was performed to develop a patient-reported outcome measure (PROM) for patients with chronic heart failure and evaluate its reliability, validity, and feasibility.According to the standard PROM guidelines established by the Food and Drug Administration, an item pool was formed by reviewing a large amount of relevant literature and interviewing patients with chronic heart failure about their main symptoms. Thus, the primary scale was created after adjusting the items and language with the help of patients and experts in the field. Next, 155 patients from 8 hospitals in different districts were recruited for a pilot survey using questionnaires containing these items. The patients' responses were analyzed using the classical test theory and item response theory to select high-quality items and determine the subdomains of the scale. This was followed by a formal investigation in the same eight hospitals. In total, 360 patients and 100 healthy subjects were included to evaluate the reliability, validity, and feasibility of the items. Through this process, the final scale was established.The final scale comprised 12 subdomains with 57 items related to physical, psychological, social, and therapeutic areas. The data analysis results of the formal investigation showed that the PROM for chronic heart failure had good reliability, validity, and feasibility. Reliability was verified by Cronbach's alpha coefficient, which was 0.913 for the total scale, 0.903 for the physical domain, 0.941 for the psychological domain, 0.827 for the social domain, and 0.839 for the therapeutic domain. The construct validity results met the relative criteria of confirmatory factor analysis. Discriminant validity was represented by score comparisons of nine subdomains. The response rate and the effective rate of return of the CHF-PROM were 98.94% and 98.92%, respectively.The final scale coincides with the theoretical framework and better reflects the overall quality of life of patients with chronic heart failure. This scale can be used as a valid instrument to evaluate clinical treatment and clinical trials of chronic heart failure.

Project description:INTRODUCTION:Listening effort may be defined as the cognitive resources needed to understand an auditory message. A sustained requirement for listening effort is known to have a negative impact on individuals' sense of social connectedness, well-being and quality of life. A number of hearing-specific patient-reported outcome measures (PROMs) exist currently; however, none adequately assess listening effort as it is experienced in the listening situations of everyday life. The Listening Effort Questionnaire-Cochlear Implant (LEQ-CI) is a new, hearing-specific PROM designed to assess perceived listening effort as experienced by adult CI patients. It is the aim of this study to conduct the first psychometric evaluation of the LEQ-CI's measurement properties. METHODS AND ANALYSIS:This study is a phased, prospective, multi-site validation study in a UK population of adults with severe-profound sensorineural hearing loss who meet local candidacy criteria for CI. In phase 1, 250 CI patients from four National Health Service CI centres will self-complete a paper version of the LEQ-CI. Factor analysis will establish unidimensionality and Rasch analysis will evaluate item fit, differential item functioning, response scale ordering, targeting of persons and items, and reliability. Classical test theory methods will assess acceptability/data completeness, scaling assumptions, targeting and internal consistency reliability. Phase 1 results will inform refinements to the LEQ-CI. In phase 2, a new sample of adult CI patients (n=100) will self-complete the refined LEQ-CI, the Speech, Spatial and Qualities of Hearing Scale, the Nijmegen Cochlear Implant Questionnaire and the Fatigue Assessment Scale to assess construct validity. ETHICS AND DISSEMINATION:This study was approved by the Abertawe Bro Morgannwg University Health Board/Swansea University Joint Study Review Committee and the Newcastle and North Tyneside 2 Research Ethics Committee, Ref: 18/NE/0320. Dissemination will be in high-quality journals, conference presentations and SEH's doctoral dissertation.

Project description:ImportanceExisting prognostic cancer tools include biological and laboratory variables. However, patients often do not know this information, preventing them from using the tools and understanding their prognosis.ObjectiveTo develop and validate a prognostic survival model for all cancer types that incorporates information on symptoms and performance status over time.Design, setting, and participantsThis is a retrospective, population-based, prognostic study of data from patients diagnosed with cancer from January 1, 2008, to December 31, 2015, in Ontario, Canada. Patients were randomly selected for model derivation (60%) and validation (40%). The derivation cohort was used to develop a multivariable Cox proportional hazards regression model with baseline characteristics under a backward stepwise variable selection process to predict the risk of mortality as a function of time. Covariates included demographic characteristics, clinical information, symptoms and performance status, and health care use. Model performance was assessed on the validation cohort by C statistics and calibration plots. Data analysis was performed from February 6, 2018, to November 6, 2019.Main outcomes and measuresTime to death from diagnosis (year 0) recalculated at each of 4 annual survivor marks after diagnosis (up to year 4).ResultsA total of 255 494 patients diagnosed with cancer were identified (135 699 [53.1%] female; median age, 65 years [interquartile range, 55-73 years]). The cohort decreased to 217 055, 184 822, 143 649, and 109 569 patients for each of the 4 years after diagnosis. In the derivation cohort year 0, and the most common cancers were breast (30 855 [20.1%]), lung (19 111 [12.5%]), and prostate (18 404 [12.0%]). A total of 47 614 (31.1%) had stage III or IV disease. The mean (SD) time to death in year 0 was 567 (715) days. After backward stepwise selection in year 0, the following factors were associated with increased risk of death by more than 10%: being hospitalized; having congestive heart failure, chronic obstructive pulmonary disease, or dementia; having moderate to high pain; having worse well-being; having functional status in the transitional or end-of-life phase; having any problems with appetite; receiving end-of-life home care; and living in a nursing home. Model discrimination was high for all models (C statistic: 0.902 [year 0], 0.912 [year 1], 0.912 [year 2], 0.909 [year 3], and 0.908 [year 4]).Conclusions and relevanceThe model accurately predicted changing cancer survival risk over time using clinical, symptom, and performance status data and appears to have the potential to be a useful prognostic tool that can be completed by patients. This knowledge may support earlier integration of palliative care.

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BC-PROM: validation of a patient-reported outcomes measure for patients with breast cancer.

Publications

BC-PROM: validation of a patient-reported outcomes measure for patients with breast cancer.

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