Dataset Information

A new instrument for measuring anticoagulation-related quality of life: development and preliminary validation.

ABSTRACT: 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.

SUBMITTER: Samsa G

PROVIDER: S-EPMC420491 | biostudies-literature | 2004 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A new instrument for measuring anticoagulation-related quality of life: development and preliminary validation.

Samsa Greg G Matchar David B DB Dolor Rowena J RJ Wiklund Ingela I Hedner Ewa E Wygant Gail G Hauch Ole O Marple Cheryl Beadle CB Edwards Roger R

Health and quality of life outcomes 20040506

<h4>Background</h4>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 S ...[more]

PMID: 15132746

Similar Datasets

Project description:BackgroundThe quality of life among children with idiopathic scoliosis during their adolescence has been reported to be affected by the brace itself. However, a controversy exists whether brace treated scoliotics experience a poor quality of life, thus there is a need for the development of a brace-oriented instrument, as the now-existing questionnaires that are commonly used, such as the SRS -22, take into consideration the effects of both the conservative and the surgical treatment on quality of life of scoliotic children. The aim of the present study is to assess the validity and reliability of Brace Questionnaire (BrQ), a new instrument for measuring quality of life of scoliotic adolescents who are treated conservatively with a brace.Material-methodMethodology of development involved literature review, patient and health care professionals' in-depth interviews and content validity analysis on patients. A validation study was performed on 28 brace treated scoliotic children aged between 9 and 18 years old. BrQ was assessed for the following psychometric properties: item convergent validity, floor and ceiling effects, internal consistency reliability, clinical validity and responsiveness to change.ResultsBrQ is self administrated and developmentally appropriate for ages 9 to 18 years old and is consisted of 34 Likert-scale items associated with eight domains: general health perception, physical functioning, emotional functioning, self esteem and aesthetics, vitality, school activity, bodily pain and social functioning of scoliotic children treated conservatively with a brace. The subscales of these eight dimensions can be combined to produce a total score. Higher scores mean a better quality of life. An item convergent validity >/= 0.40 was satisfied by all items in the present study. A satisfactory internal consistency reliability for the BrQ was recorded (Cronbach's alpha coefficient was 0.82). There were no floor or ceiling effects. The correlation between BrQ overall scores and mild and moderate scoliosis was statistically significant (p < 0.001), revealing high clinical validity. An increase in effect sizes for the patient with improved scoliotic curves indicates that the BrQ is responsive to change in health status.ConclusionBrQ is reliable, valid and responsive to change in adolescents with IS who are treated conservatively with a brace.

Project description:BackgroundThis paper describes the development of the Chinese Quality of Life Instrument (ChQOL) which is a self-report health status instrument. Chinese Medicine relies very much on asking subjective feelings of patients in the process of diagnosis and monitoring of treatment. For thousands of years, Chinese Medicine practitioners have accumulated a good wealth of experiences in asking questions about health of their patients based on the concept of health in Chinese Medicine. These experiences were then transformed into questions for the ChQOL. It is believed that ChQOL can contribute to the existing Patient Report Outcome measures. This paper outlines the concept of health and disease in Traditional Chinese Medicine, the building of the conceptual framework of the ChQOL, the steps of drafting, selecting and validating the items, and the psychometric properties of the ChQOL.MethodsThe development of the ChQOL was based on the concept of health in Traditional Chinese Medicine with a theory driven approach. Based on the results of literature review, the research team developed an initial model of health which encompassed the concept of health in TCM. An expert panel was then invited to comment and give suggestions for improvement of the initial model. According to their suggestions, the model was refined and a set of initial items for the ChQOL was drafted. The refined model, together with the key domains, facets and initial items of the ChQOL were then mailed to a sample of about 100 Chinese medicine practitioners throughout Mainland China for their comments and advice. A revised set of items were developed for linguistic testing by a convenience sample consisting of both healthy people and people who attended Chinese Medicine treatment. After that, an item pool was developed for field-testing. Field test was conducted on a convenience sample of healthy and patient subjects to determine the construct validity and psychometric properties of the ChQOL.ResultsConstruct validity was established by various methods, i.e. the internal consistency in all facets and domains were good; the correlation between facets to domain, and domains to overall ChQOL correlation were high; confirmatory factor analysis showed that the structure fitness of all facets, domain and overall structure were good with CFI > 0.9. Test-retest reliability was also good, especially in the domain scores with ICC value ranging from 0.83 to 0.90. No ceiling or floor effect was noted which indicated that ChQOL can be applied to subjects with a wide range of health status. Most facet scores, domain scores and the overall CHQOL scores were able to discriminate groups of subjects with known differences in health status. The ChQOL had mild positive convergence with the other generic health related QOL measures, i.e. the WHOQOL-100 and the SF-36, with moderate correlations.ConclusionIn conclusion, the study indicated that the ChQOL is conceptually valid with satisfactory psychometric properties. It can provide additional information on health and QOL on top of the existing generic health related QOL measures. Furthermore, it forms basis for further testing and applications in clinical trials.

Project description:OBJECTIVE:Medication-related burden (MRB) is a negative experience with medicine, which may impact on psychological, social, physical and financial well-being of an individual. This study describes the development and initial validation of an instrument specifically designed to measure MRB on functioning and well-being-the Medication-Related Burden Quality of Life (MRB-QoL) tool. METHODS:An initial pool of 76-items for MRB-QoL was generated. The link to MRB-QoL survey was sent to a sample of consumers living with at least one chronic medical condition and taking ?3?prescription medicines on a regular basis. Exploratory factor analysis (EFA) was used to determine the underlining factor structure. Internal consistency (Cronbach's ?) and construct validity were examined. The latter was examined through correlation with Medication Regimen Complexity Index (MRCI), Drug Burden Index (DBI) and Charlson's Comorbidity Index (CCI). RESULTS:367 consumers completed the survey (51.2% male). EFA resulted in a 31-item, five-factor solution explaining 72% of the total variance. The five subscales were labelled as 'Routine and Regimen Complexity' (11 items), 'Psychological Burden' (six items), 'Functional and Role Limitation' (seven items), 'Therapeutic Relationship' (three items) and 'Social Burden' (four items). All subscales showed good internal consistency (Cronbach's ? 0.87 to 0.95). Discriminant validity of MRB-QoL was demonstrated via its correlations with MRCI (Spearman's r -0.16 to 0.08), DBI (r 0.12 to 0.28) and CCI (r -0.23 to -0.15). Correlation between DBI and 'Functional and Role Limitation' subscale (r 0.36) indicated some evidence of convergent validity. Patients with polypharmacy, multiple morbidity and DBI >0 had higher median scores of MRB-QoL providing evidence for known group validity. CONCLUSIONS:The MRB-QoL V.1 has good construct validity and internal consistency. The MRB-QoL may be a useful humanistic measure for evaluating the impact of pharmaceutical care interventions on patients' quality of life. Future research is warranted to further examine additional psychometric properties of MRB-QoL V.1 and its utility in patient care.

Project description:This study describes the development of a new questionnaire to measure health-related quality of life (HRQoL) in patients with type 1 diabetes (the ViDa1 questionnaire) and provides information on its psychometric properties. For its development, open interviews with patients took place and topics relevant to patients' HRQoL were identified and items were generated. Qualitative analysis of items, expert review, and refinement of the questionnaire followed. A pilot study (N = 150) was conducted to explore the underlying structure of the 40-item ViDa1 questionnaire. A Principal Component Analysis (PCA) was performed and six of the items that did not load on any of the factors were eliminated. The results supported a four-dimensional structure for ViDa1, the dimensions being Interference of diabetes in everyday life, Self-care, Well-being, and Worry about the disease. Subsequently, the PCA was repeated in a larger sample (N = 578) with the reduced 34-item version of the questionnaire, and a Confirmatory Factor Analysis (CFA) was performed (N = 428). Overall fit indices obtained presented adequate values which supported the four-factor model initially proposed [([Formula: see text] 2601.93) (p < 0.001); Root Mean Square Error of Approximation = 0.060 (CI = 0.056 -0.064)]. As regards reliability, the four dimensions of the ViDa1 demonstrated good internal consistency, with Cronbach's alphas ranging between 0.71 and 0.86. Evidence of convergent-discriminant validity in the form of high correlations with another specific HRQoL questionnaire for diabetes and low correlations with other constructs such as self-efficacy, anxiety, and depression were presented. The ViDa1 also discriminated between different aspects of clinical interest such as type of insulin treatment, presence of chronic complications, and glycemic control, temporal stability, and sensitivity to change after an intervention. In conclusion, the ViDa1 questionnaire presents adequate psychometric properties and may represent a good alternative for the evaluation of HRQoL in type 1 diabetes.

Project description:IntroductionAmblyopia is a neurodevelopmental vision disorder, characterized by poor vision in one or both eyes. Given the lack of existing clinical outcome assessments (COA) considered fit-for-purpose for amblyopia clinical trials, this study developed new COAs to assess amblyopia symptoms and health-related quality of life (HRQoL) impacts in adult and pediatric amblyopia populations that conform with best practice standards and regulatory guidelines.MethodsFindings from a targeted qualitative literature review informed the development of three versions of the new Amblyopia Quality of Life Questionnaire (AmbQoL): a patient-reported outcome measure (PRO) for individuals aged 13 years and older, a PRO for children aged 9-12 years, and an observer-reported outcome measure (ObsRO) for caregivers of children aged 4-8 years. Qualitative interviews were conducted with the target populations, and with ophthalmologists experienced in treating amblyopia patients to evaluate the content validity for further development of the AmbQoL. A translatability assessment was conducted to ensure cultural appropriateness and usability across multiple languages. Feedback from Food and Drug Administration (FDA) was also sought on the instruments, and clinical experts provided input at key stages.ResultsInterviews were conducted with 112 patients/caregivers and ten ophthalmologists from the USA, France, and Germany. The instructions, items, and response options were well understood across all AmbQoL versions. Feedback from the patients, caregivers, ophthalmologists, the translatability assessment, the FDA, and the expert clinicians informed minor wording modifications to enhance clarity and translatability. Some items were removed due to low relevance. The study resulted in a 23-item adult/adolescent PRO, 24-item child PRO, and 12-item ObsRO, each employing a 7-day recall period.ConclusionEach AmbQoL version has documented support for its face and content validity for use in amblyopia populations aged ≥ 4 years. Further research is necessary to evaluate the psychometric measurement properties of the AmbQoL instruments to enable their use in amblyopia treatment trials.

Project description: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.

Project description:Background and aimsImproving the quality of pre-hospital traumatic shock care, especially in low- and middle-income countries, is particularly relevant to reducing the large global burden of disease from injury. What clinical interventions represent high-quality care is an actively evolving field and often dependent on the specific injury pattern. A key component of improving the quality of care is having a consistent way to assess and measure the quality of shock care in the pre-hospital setting. The objective of this study was to develop and validate a chart abstraction instrument to measure the quality of trauma care in a resource-limited, pre-hospital emergency care setting.MethodsTraumatic shock was selected as the tracer condition. The pre-hospital quality of traumatic shock care (QTSC) instrument was developed and validated in three phases. A content development phase utilized a rapid literature review and expert consensus to yield the contents of the draft instrument. In the instrument validation phase, the QTSC instrument was created and underwent end user and content validation. A pilot-testing phase collected user feedback and performance characteristics to iteratively refine draft versions into a final instrument. Accuracy and inter- and intra-rater agreement were calculated.ResultsThe final QTSC instrument contains 10 domains of quality, each with specific criteria that determine how the domain is measured and the level of quality of care rendered. The instrument is over 90% accurate and has good inter- and intra-rater reliability when used by trained pre-hospital provider users in South Africa. Pre-hospital provider user feedback indicates the tool is easy to learn and quick to use.ConclusionWe created and validated a novel chart abstraction instrument that can reliably and accurately measure the quality of pre-hospital traumatic shock care. We provide a systematic methodology for developing and validating a quality of care tool for resource-limited care settings.

Dataset Information

A new instrument for measuring anticoagulation-related quality of life: development and preliminary validation.

Publications

A new instrument for measuring anticoagulation-related quality of life: development and preliminary validation.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets