Dataset Information

An Electronic Patient-Reported Outcome Tool for the FACT-B (Functional Assessment of Cancer Therapy-Breast) Questionnaire for Measuring the Health-Related Quality of Life in Patients With Breast Cancer: Reliability Study.

ABSTRACT:

Background

The most frequent malignant disease in women is breast cancer. In the metastatic setting, quality of life is the primary therapeutic goal, and systematic treatment has only a limited effect on survival rates; therefore, the concept of the health-related quality of life (HRQoL) and measurement of patient-reported outcomes (PROs) are gaining more and more importance in the therapy setting of diseases such as breast cancer. One of the frequently used questionnaires for measuring the HRQoL in patients with breast cancer is the Functional Assessment of Cancer Therapy-Breast (FACT-B). Currently, paper-based surveys still predominate, as only a few reliable and validated electronic-based questionnaires are available. ePRO tools for the FACT-B questionnaire with proven reliability are missing so far.

Objective

The aim of this study was to analyze the reliability of tablet-based measurement of FACT-B in the German language in adjuvant (curative) and metastatic breast cancer patients.

Methods

Paper- and tablet-based questionnaires were completed by a total of 106 female adjuvant and metastatic breast cancer patients. All patients were required to complete the electronically based (ePRO) and paper-based version of the FACT-B. A frequency analysis was performed to determine descriptive sociodemographic characteristics. Both dimensions of reliability (parallel forms reliability using Wilcoxon test and test of internal consistency using Spearman ρ) and agreement rates for single items, Kendall tau for each subscale, and total score were analyzed.

Results

High correlations were shown for both dimensions of reliability (parallel forms reliability and internal consistency) in the patients' response behavior between paper-based and electronically based questionnaires. Regarding the reliability test of parallel forms, no significant differences were found in 35 of 37 single items, while significant correlations in the test for consistency were found in all 37 single items, in all 5 sum individual item subscale scores, as well as in total FACT-B score.

Conclusions

The ePRO version of the FACT-B questionnaire is reliable for patients with breast cancer in both adjuvant and metastatic settings, showing highly significant correlations with the paper-based version in almost all questions all subscales and the total score.

SUBMITTER: Matthies LM

PROVIDER: S-EPMC6362389 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

An Electronic Patient-Reported Outcome Tool for the FACT-B (Functional Assessment of Cancer Therapy-Breast) Questionnaire for Measuring the Health-Related Quality of Life in Patients With Breast Cancer: Reliability Study.

Matthies Lina Maria LM Taran Florin-Andrei FA Keilmann Lucia L Schneeweiss Andreas A Simoes Elisabeth E Hartkopf Andreas D AD Sokolov Alexander N AN Walter Christina B CB Sickenberger Nina N Wallwiener Stephanie S Feisst Manuel M Gass Paul P Lux Michael P MP Schuetz Florian F Fasching Peter A PA Sohn Christof C Brucker Sara Y SY Graf Joachim J Wallwiener Markus M

Journal of medical Internet research 20190122 1

<h4>Background</h4>The most frequent malignant disease in women is breast cancer. In the metastatic setting, quality of life is the primary therapeutic goal, and systematic treatment has only a limited effect on survival rates; therefore, the concept of the health-related quality of life (HRQoL) and measurement of patient-reported outcomes (PROs) are gaining more and more importance in the therapy setting of diseases such as breast cancer. One of the frequently used questionnaires for measuring ...[more]

PMID: 30668517

Similar Datasets

Project description:ObjectiveThe aim of the study is to identify and prioritize early intervention (EI) stakeholders' perspectives of supports and barriers to implementing the Young Children's Participation and Environment Measure (YC-PEM), an electronic patient-reported outcome (e-PRO) tool, for scaling its implementation across multiple local and state EI programs.MethodsAn explanatory sequential (quan > QUAL) mixed-methods study was conducted with EI families (n = 6), service coordinators (n = 9), and program leadership (n = 7). Semi-structured interviews and focus groups were used to share select quantitative pragmatic trial results (e.g., percentages for perceived helpfulness of implementation strategies) and elicit stakeholder perspectives to contextualize these results. Three study staff deductively coded transcripts to constructs in the Consolidated Framework for Implementation Research (CFIR). Data within CFIR constructs were inductively analyzed to generate themes that were rated by national early childhood advisors for their relevance to longer term implementation.ResultsAll three stakeholder groups (i.e., families, service coordinators, program leadership) identified thematic supports and barriers across multiple constructs within each of four CFIR domains: (1) Six themes for "intervention characteristics," (2) Six themes for "process," (3) three themes for "inner setting," and (4) four themes for "outer setting." For example, all stakeholder groups described the value of the YC-PEM e-PRO in forging connections and eliciting meaningful information about family priorities for efficient service plan development ("intervention characteristics"). Stakeholders prioritized reaching families with diverse linguistic preferences and user navigation needs, further tailoring its interface with automated data capture and exchange processes ("process"); and fostering a positive implementation climate ("inner setting"). Service coordinators and program leadership further articulated the value of YC-PEM e-PRO results for improving EI access ("outer setting").ConclusionResults demonstrate the YC-PEM e-PRO is an evidence-based intervention that is viable for implementation. Optimizations to its interface are needed before undertaking hybrid type-2 and 3 multisite trials to test these implementation strategies across state and local EI programs with electronic data capture capabilities and diverse levels of organizational readiness and resources for implementation.

Project description:IntroductionCancer patients experience different complications and outcomes during or after medical treatments. Electronic reporting of the outcomes by patients is a solution that facilitates communication with physicians and improve patient health status. The aim of this study was to develop a smartphone-based application for electronic reporting of outcomes by patients with prostate cancer.MethodsThe present research was conducted in 2021 in two phases. In the first phase, initially, users' requirements were identified based on reviewing the related literature, existing applications, and guidelines. Then, a questionnaire was designed and the specialists' opinions about the users' requirements were investigated. The specialties included urologists, hemato-oncologists, uro-oncologists, and radiotherapists (n = 15). In the second phase, the application was designed, and patients with prostate cancer (n = 21) and specialists (n = 10) evaluated it using the post-study system usability questionnaire (PSSUQ). Data were analyzed using descriptive statistics.ResultsThe findings of the first phase of the research showed that out of 108 data elements and functions proposed for the application, 91 items were found essential by the specialists. Data elements were categorized into the patient data, general complications of prostate cancer and side effects of drug therapy, surgery, chemotherapy, cryotherapy, radiation therapy, and hormone therapy. Necessary functions for the application included presenting a patient care summary, communication between the patient and the specialist, free text explanation for complications and sides effects, generating reports, reminder and alert, completing quality of life questionnaire, and calculating the score for the questionnaire. In the second phase of the research, the application was developed and evaluated. The mean value for user satisfaction was (5.95 ± 0.55) out of 7.ConclusionThe developed application can help to accelerate communication with the specialists. It can improve quality of care, reduce unnecessary treatment visits and side effects, and improve timely data collection for a variety of research purposes. However, further research on the cost-effectiveness and usefulness of the collected data is recommended.

Project description:BackgroundPatient-reported outcome measures are increasingly used by clinicians to support communication in telephone- or face-to-face consultations with patients. A renal disease questionnaire has been developed, but not sufficiently evaluated through clinimetrics in clinical setting. Hence, we aimed to evaluate the content validity, construct validity and the test-retest reliability of a renal disease questionnaire to be used for clinical decision-making.MethodsA content, construct validity and test-retest reliability study was conducted in 3 nephrology outpatient clinics in Central Denmark Region, Denmark. Content validity (face validity, comprehensibility and relevance) was assessed among 8 patients and 6 clinicians. Reliability was assessed by asking outpatients with chronic kidney disease to complete the questionnaire twice. Reliability was assessed by kappa statistics and agreement by percentage. Construct validity was determined using 4 a priori defined hypotheses and comparing 2 known groups.ResultsFive new domains emerged, 6 items were rephrased and 3 items were removed following the content validity test. A total of 160 patients completed the questionnaire with median 8 days (IQR 2 days) between assessments. The test-retest reliability parameters of the single items in the questionnaire were substantial to almost perfect as all the observed weighted kappa values ranged from 0.61 to 0.91, 95% CI (0.34 to 0.95). In total, 61% of the single items showed almost perfect agreement. In total, 3 of the 4 hypotheses were accepted and 44% of the items showed satisfying known-group discriminative validity.ConclusionA renal disease questionnaire used for clinical decision-making in outpatient follow-up showed acceptable content validity and substantial to almost perfect reliability. Sufficient construct validity was not established. Incorporating the questionnaire into routine clinical practice may improve the evaluation of disease burden in patients with chronic kidney disease. We ask patients with chronic kidney disease (CKD) in Central Region Denmark to complete a questionnaire before each outpatient visit. The answers they provide are used to support communication with their health care provider. A questionnaire requires testing to ensure it can accurately capture important information about patient's symptoms and quality of life. When questionnaires are used to support communication between patients and health care professionals, they need to have good measurement properties. This means they need to be: (1) trustworthy, (2) relevant to a patient's health condition, (3) consistent and produce stable results every time. We explored the measurement properties of a questionnaire designed to be used in the face-to face outpatient visits for patients with CKD. We found that the questionnaire captured consistent and stable results. Using this questionnaire may help health care professionals to assess the patients´ burden of symptoms with a more patient-centered approach. Potentially, the use of the questionnaire will increase the patients´ ability to cope with their symptoms and strengthen patients´ involvement in the clinical decisions concerning their treatment.

Project description:BACKGROUND:Designing appropriate studies for evaluating complex interventions, such as electronic health solutions to support integrated care, remains a methodological challenge. With the many moving parts of complex interventions, it is not always clear how program activities are connected to anticipated and unanticipated outcomes. Exploratory trials can be used to uncover determinants (or mechanisms) to inform content theory that underpins complex interventions before designing a full evaluation plan. OBJECTIVE:A multimethod exploratory trial of the electronic patient-reported outcome (ePRO) tool was conducted to uncover contexts, processes and outcome variables, and the mechanisms that link these variables before full-scale evaluation. ePRO is a mobile app and portal designed to support goal-oriented care in interdisciplinary primary health care practices (clinical-level integration). This paper offers evaluation findings and methodological insight on how to use exploratory trial data to identify relevant context, process, and outcome variables, as well as central (necessary to achieving outcomes) versus peripheral (less critical and potentially context dependent) mechanisms at play. METHODS:The 4-month trial was conducted in 2 primary health care practices in Toronto, Canada. The patients were randomized into control and intervention groups and compared pre and post on quality of life and activation outcome measures. Semistructured interviews were conducted with providers and patients in the intervention group. Narrative analysis was used to uncover dominant mechanisms that inform the intervention's content theory (how context and process variables are linked to outcomes). RESULTS:Overall, 7 providers, 1 administrator, and 16 patients (7-control, 9-intervention) participated in the study. This study uncovered many complex and nuanced context, process, and outcome variables at play in the intervention. Narrative analysis of patient and provider interviews revealed dominant story lines that help to tease apart central and peripheral mechanisms driving the intervention. Provider and patient story lines centered around fitting the new intervention into everyday work and life of patients and providers and meaningfulness of the intervention. These themes were moderated by patient-provider relationships going into and throughout the intervention, their comfort with technology, and the research process. CONCLUSIONS:Identifying dominant story lines using narrative analysis helps to identify the most relevant context and process variables likely to influence study outcomes. Normalization process theory emerges as a useful theory to uncover underlying mechanisms because of its emphasis on the social production and normalization of technological, processual, and social aspects of work; all found to be critical to our intervention. The number of complex, overlapping influencing variables suggests that complex interventions such as ePRO require us to pay careful attention to central versus peripheral mechanisms that will influence study outcomes. The narrative methods presented here are shown to be useful in uncovering these mechanisms and help to guide subsequent larger evaluation studies.

Dataset Information

An Electronic Patient-Reported Outcome Tool for the FACT-B (Functional Assessment of Cancer Therapy-Breast) Questionnaire for Measuring the Health-Related Quality of Life in Patients With Breast Cancer: Reliability Study.

Background

Objective

Methods

Results

Conclusions

Publications

An Electronic Patient-Reported Outcome Tool for the FACT-B (Functional Assessment of Cancer Therapy-Breast) Questionnaire for Measuring the Health-Related Quality of Life in Patients With Breast Cancer: Reliability Study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets