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Development of a Short Instrument for Measuring Health-Related Quality of Life in Oncological Patients for Clinical Use: Protocol for an Observational Study.

ABSTRACT: BACKGROUND:Cancer patients often suffer from the physical and psychological burden of their disease and its treatment. This is frequently insufficiently identified and addressed in clinical practice. In the context of improving patient-centered care in oncological patients, patient-reported outcomes (PROs) represent an important addition to current routine care. So far, available PRO questionnaires for cancer patients are unsuitable for routine procedures due to their length and complexity. OBJECTIVE:This study aimed to develop and psychometrically test a short questionnaire to measure health-related quality of life (HrQoL) in cancer patients for use in routine care. METHODS:This observational study consists of two parts: (1) a qualitative study to develop a short questionnaire measuring HrQoL and (2) a quantitative study to psychometrically test this questionnaire in five oncological departments of a comprehensive cancer center. In part 1 of the study, semistructured interviews with 28 cancer patients, as well as five focus groups with 22 clinicians and nurses, were conducted to identify clinically relevant dimensions of HrQoL. The identified dimensions were complemented with related dimensions from empirical studies and reviewed via expert discussion. Based on this, a short instrument was developed. In part 2 of the study, the developed questionnaire was tested in cancer in- and outpatients at five participating oncological clinics using additional standardized questionnaires assessing HrQoL and other important PROs. The questionnaire was presented to more than 770 patients twice during treatment. RESULTS:The project started in May 2017 with recruitment for study phase I beginning in December 2017. Recruitment for study phases I and II ended in April 2018 and February 2019, respectively. After study phase II and psychometrical analyses, the newly developed questionnaire measuring the HrQoL of all cancer entities in routine care was finalized. CONCLUSIONS:With five to six dimensions and one item per dimension, the developed questionnaire is short enough to not disrupt routine procedures during treatment and is profound enough to inform clinicians about the patient's HrQoL impairments and status. TRIAL REGISTRATION:Open Science Framework Registries 10.17605/OSF.IO/Y7XCE; https://osf.io/y7xce/. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR1-10.2196/17854.

SUBMITTER: Schrage T

PROVIDER: S-EPMC7424483 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Development of a Short Instrument for Measuring Health-Related Quality of Life in Oncological Patients for Clinical Use: Protocol for an Observational Study.

Schrage Theresa T Görlach Mirja M Betz Christian Stephan CS Bokemeyer Carsten C Kröger Nicolaus N Kröger Nicolaus N Mueller Volkmar V Petersen Cordula C Krüll Andreas A Schulz Holger H Bleich Christiane C

JMIR research protocols 20200729 7

<h4>Background</h4>Cancer patients often suffer from the physical and psychological burden of their disease and its treatment. This is frequently insufficiently identified and addressed in clinical practice. In the context of improving patient-centered care in oncological patients, patient-reported outcomes (PROs) represent an important addition to current routine care. So far, available PRO questionnaires for cancer patients are unsuitable for routine procedures due to their length and complexi ...[more]

PMID: 32726289

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Project description:BACKGROUND: Anticoagulation can reduce quality of life, and different models of anticoagulation management might have different impacts on satisfaction with this component of medical care. Yet, to our knowledge, there are no scales measuring quality of life and satisfaction with anticoagulation that can be generalized across different models of anticoagulation management. We describe the development and preliminary validation of such an instrument - the Duke Anticoagulation Satisfaction Scale (DASS). METHODS: The DASS is a 25-item scale addressing the (a) negative impacts of anticoagulation (limitations, hassles and burdens); and (b) positive impacts of anticoagulation (confidence, reassurance, satisfaction). Each item has 7 possible responses. The DASS was administered to 262 patients currently receiving oral anticoagulation. Scales measuring generic quality of life, satisfaction with medical care, and tendency to provide socially desirable responses were also administered. Statistical analysis included assessment of item variability, internal consistency (Cronbach's alpha), scale structure (factor analysis), and correlations between the DASS and demographic variables, clinical characteristics, and scores on the above scales. A follow-up study of 105 additional patients assessed test-retest reliability. RESULTS: 220 subjects answered all items. Ceiling and floor effects were modest, and 25 of the 27 proposed items grouped into 2 factors (positive impacts, negative impacts, this latter factor being potentially subdivided into limitations versus hassles and burdens). Each factor had a high degree of internal consistency (Cronbach's alpha 0.78-0.91). The limitations and hassles factors consistently correlated with the SF-36 scales measuring generic quality of life, while the positive psychological impact scale correlated with age and time on anticoagulation. The intra-class correlation coefficient for test-retest reliability was 0.80. CONCLUSIONS: The DASS has demonstrated reasonable psychometric properties to date. Further validation is ongoing. To the degree that dissatisfaction with anticoagulation leads to decreased adherence, poorer INR control, and poor clinical outcomes, the DASS has the potential to help identify reasons for dissatisfaction (and positive satisfaction), and thus help to develop interventions to break this cycle. As an instrument designed to be applicable across multiple models of anticoagulation management, the DASS could be crucial in the scientific comparison between those models of care.

Project description:BACKGROUND:Health literacy is the ability to access to, understand, evaluate and use of essential health information to make basic health decisions. This study aimed to develop and psychometrically evaluate an instrument for measuring health literacy among adults (the Health Literacy Instrument for Adults - HELIA). METHODS:In addition to a literature review, a panel of specialists from different disciplines was formed to generate an item pool. Then, a framework was defined to develop the initial questionnaire based on a definition of health literacy and the most important global public health issues. The initial questionnaire contained 66 items. Next, 15 experts in public health were approached to assess content validity. Consequently, 19 items were removed and a provisional version of the questionnaire with 47 items was provided. Finally, a random sample of adults completed the questionnaire and psychometric properties of the instrument were assessed. RESULTS:Overall, 323 adults aged 18 to 65?years old completed the questionnaire. When the exploratory factor analysis was performed, 33 items were loaded, which indicated a 5-factor solution for the questionnaire that jointly explained 52.9% of the variance observed. The factors were as follows: access to information (6 items), reading (4 items), understanding (7 items), appraisal (4 items), and decision making/behavioral intention (12 items). Confirmatory factory analysis also indicated a good fit to the data for the five-latent structure (?2/df?=?1.60, SRMR?=?0.049; RMSEA?=?0.043; CFI?=?0.98; NFI?=?0.95; NNFI?=?0.98 and GFI?=?0.87). Additional analysis for internal consistency showed satisfactory results with Cronbach's alpha coefficients ranging from 0.72 to 0.89. Intraclass correlation coefficient (test-retest analysis) also showed acceptable stability for the questionnaire (ICC?=?0.84). The mean score for health literacy as measured by the HELIA was 76.3 (SD?=?15.1) out of 100 for the study sample. CONCLUSION:The findings suggest that the Health Literacy Instrument for Adults (HELIA) is a valid and reliable instrument for measuring health literacy. It is a short and easy-to-use instrument that could be applied in different settings.

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Dataset Information

Development of a Short Instrument for Measuring Health-Related Quality of Life in Oncological Patients for Clinical Use: Protocol for an Observational Study.

Publications

Development of a Short Instrument for Measuring Health-Related Quality of Life in Oncological Patients for Clinical Use: Protocol for an Observational Study.

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