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Using a quality of life (QoL)-monitor: preliminary results of a randomized trial in Dutch patients with early breast cancer.

ABSTRACT: PURPOSE:The diagnosis and treatment of cancer negatively affect patients' physical, functional and psychological wellbeing. Patients' needs for care cannot be addressed unless they are recognized by healthcare providers (HCPs). The use of quality of life (QoL) assessments with feedback to HCPs might facilitate the identification and discussion of QoL-topics. METHODS:113 patients with stage I-IIIB breast cancer treated with chemotherapy were included in this randomized controlled trial. Patients were randomly allocated to receive either usual care, or usual care with an intervention consisting of a QoL-monitor assessing QoL, distress and care needs before every chemotherapy cycle visit. Patients completed questionnaires regarding QoL, illness perceptions, self-efficacy, and satisfaction with communication. From the 2nd visit onwards, patients in the intervention arm and their HCPs received a copy of the QoL overview and results were shown in patients' medical files. Audio-recordings and patients' self-reports were used to investigate effects on communication, patient management and patient-wellbeing. A composite score for communication was calculated by summing the number of QoL-topics discussed during each consultation. RESULTS:Use of the QoL-monitor resulted in a higher communication score (0.7 topics increase per visit, p?=?0.04), especially regarding the disease-specific and psychosocial issues (p?

SUBMITTER: Lugtenberg RT

PROVIDER: S-EPMC7591431 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Using a quality of life (QoL)-monitor: preliminary results of a randomized trial in Dutch patients with early breast cancer.

Lugtenberg R T RT Fischer M J MJ de Jongh F F Kobayashi K K Inoue K K Matsuda A A Kubota K K Weijl N N Yamaoka K K Ramai S R S SRS Nortier J W R JWR Putter H H Gelderblom H H Kaptein A A AA Kroep J R JR

Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation 20200611 11

<h4>Purpose</h4>The diagnosis and treatment of cancer negatively affect patients' physical, functional and psychological wellbeing. Patients' needs for care cannot be addressed unless they are recognized by healthcare providers (HCPs). The use of quality of life (QoL) assessments with feedback to HCPs might facilitate the identification and discussion of QoL-topics.<h4>Methods</h4>113 patients with stage I-IIIB breast cancer treated with chemotherapy were included in this randomized controlled t ...[more]

PMID: 32529343

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Project description:ObjectiveUterine fibroids can cause a variety of symptoms in women, from heavy menstrual bleeding and dysmenorrhea to bulk symptoms. The Uterine Fibroid Symptom and health-related Quality Of Life questionnaire (UFS-QOL) is a patient-reported outcome measure developed for assessing fibroid-related symptoms in a standardised way. Our aim was to translate and validate the UFS-QOL in Dutch.DesignValidation study.SettingPatients were recruited by a gynaecologist at the outpatient clinic.ParticipantsWomen with uterine fibroids.MethodsThe UFS-QOL was translated into Dutch (UFS-QOL NL) and validated through testing construct validity (comprising of structural validity and hypotheses testing), reliability, responsiveness and interpretability, assessing floor and ceiling effects and minimal important change. An option to answer 'not applicable' was added to the translated questionnaire.Results191 women with uterine fibroids completed the UFS-QOL NL at baseline, after 2 weeks and after 3 months. The questionnaire retained the same factor structure after translation (Comparative Fit Index 0.94-0.95; Tucker-Lewis fit Index 0.93-0.95; Root Mean Square Error of Approximation 0.10-0.11) and correlations to other questionnaires (RAND 36, Hospital Anxiety and Depression Scale and Golombok Rust Inventory of Sexual Satisfaction) were generally moderate, as hypothesised (Pearson's r 0.3-0.7). We found a sufficient reliability with intraclass correlation coefficients of approximately 0.8-0.9 for all subscales. Responsiveness was sufficient when testing hypotheses comparing women who had surgery with those who did not. Cronbach's alpha was higher than 0.7 for all subscales, indicating sufficient internal consistency and there were no concerns about floor or ceiling effects. Minimal important change could not be calculated due to low correlation between the different subscales and the anchor question.ConclusionsThe results support the measurement properties of the Dutch UFS-QOL for assessing fibroid-related symptoms and health-related quality of life in Dutch women with uterine fibroids.

Project description:BackgroundThe Swallowing Quality-of-Life Questionnaire (SWAL-QoL) is considered the gold standard for assessing health-related QoL in oropharyngeal dysphagia. The Dutch translation (DSWAL-QoL) and its adjusted version (aDSWAL-QoL) have been validated using classical test theory (CTT). However, these scales have not been tested against the Rasch measurement model, which is required to establish the structural validity and objectivity of the total scale and subscale scores. Thus, the purpose of this study was to examine the psychometric properties of these scales using item analysis according to the Rasch model.MethodsItem analysis with the Rasch model was performed using RUMM2030 software with previously collected data from a validation study of 108 patients. The assessment included evaluations of overall model fit, reliability, unidimensionality, threshold ordering, individual item and person fits, differential item functioning (DIF), local item dependency (LID) and targeting.ResultsThe analysis could not establish the psychometric properties of either of the scales or their subscales because they did not fit the Rasch model, and multidimensionality, disordered thresholds, DIF, and/or LID were found. The reliability and power of fit were high for the total scales (PSI = 0.93) but low for most of the subscales (PSI < 0.70). The targeting of persons and items was suboptimal. The main source of misfit was disordered thresholds for both the total scales and subscales. Based on the results of the analysis, adjustments to improve the scales were implemented as follows: disordered thresholds were rescaled, misfit items were removed and items were split for DIF. However, the multidimensionality and LID could not be resolved. The reliability and power of fit remained low for most of the subscales.ConclusionsThis study represents the first analyses of the DSWAL-QoL and aDSWAL-QoL with the Rasch model. Relying on the DSWAL-QoL and aDSWAL-QoL total and subscale scores to make conclusions regarding dysphagia-related HRQoL should be treated with caution before the structural validity and objectivity of both scales have been established. A larger and well-targeted sample is recommended to derive definitive conclusions about the items and scales. Solutions for the psychometric weaknesses suggested by the model and practical implications are discussed.

Project description:ImportancePatients with acute coronary syndrome (ACS) and elevated depressive symptoms are at increased risk for recurrent cardiovascular events and mortality, worse quality of life, and higher health care costs. These observational findings prompted multiple scientific panels to advise universal depression screening in survivors of ACS prior to evidence from randomized screening trials.ObjectiveTo determine whether systematically screening for depression in survivors of ACS improves quality of life and depression compared with usual care.Design, setting, and participantsA 3-group multisite randomized trial enrolled 1500 patients with ACS from 4 health care systems between November 1, 2013, and March 31, 2017, with follow-up ending July 31, 2018. Patients were eligible if they had been hospitalized for ACS in the previous 2 to 12 months and had no prior history of depression. All analyses were performed on an intention-to-treat basis.InterventionsPatients with ACS were randomly assigned 1:1:1 to receive (1) systematic depression screening using the 8-item Patient Health Questionnaire, with notification of primary care clinicians and provision of centralized, patient-preference, stepped depression care for those with positive screening results (8-item Patient Health Questionnaire score ≥10; screen, notify, and treat, n = 499); (2) systematic depression screening, with notification of primary care clinicians for those with positive screening results (screen and notify, n = 501); and (3) usual care (no screening, n = 500).Main outcomes and measuresThe primary outcome was change in quality-adjusted life-years. The secondary outcome was depression-free days. Adverse effects and mortality were assessed by patient interview and hospital records.ResultsA total of 1500 patients (424 women and 1076 men; mean [SD] age, 65.9 [11.5] years) were randomized in the 18-month trial. Only 71 of 1000 eligible survivors of ACS (7.1%) had elevated 8-item Patient Health Questionnaire scores indicating depressive symptoms at screening. There were no differences in mean (SD) change in quality-adjusted life-years (screen, notify and treat, -0.06 [0.20]; screen and notify, -0.06 [0.20]; no screen, -0.06 [0.18]; P = .98) or cumulative mean (SD) depression-free days (screen, notify and treat, 343.1 [179.0] days; screen and notify, 351.3 [175.0] days; no screen, 339.0 [176.6] days; P = .63). Harms including death, bleeding, or sleep difficulties did not differ among groups.Conclusions and relevanceIn patients with ACS without a history of depression, systematic depression screening with or without providing depression treatment did not alter quality-adjusted life-years, depression-free days, or harms.Trial registrationClinicalTrials.gov identifier: NCT01993017.

Project description:BACKGROUND:The implementation of neonatal screening and the early initiation of lifelong therapy have helped to prevent severe complications and enabled much more favorable outcomes for early-treated phenylketonuria (ETPKU) patients. However, PKU patients tend to develop subtle cognitive and psychosocial abnormalities and the strict dietary therapy can present financial and social burden. Thus, PKU is expected to affect the quality of life (QoL) of these patients. There is insufficient evidence regarding the relationship between metabolic control and Health-Related QoL (HRQoL). We aimed to assess the effect of short- and long-term therapy on QoL among Hungarian adult PKU patients using the standardized PKU-specific PKU-QoL questionnaire. Methods: We conducted a single-centre, cross-sectional, observational study in Hungary. We included adult PKU patients treated with diet and amino acid supplements only. Patients reported HRQoL using the standardized adult PKU-QoL questionnaire and mean blood Phe concentrations were assessed for three different time periods: the previous 10 years, the previous year and concentration at the time of completing the questionnaire. The correlation between patients' QoL scores and their Phe levels was assessed. The classical PKU group was further divided into "good" and "suboptimal" adherence groups based on individual mean Phe levels in the examined time period. We evaluated differences in QoL among the two subgroups of classical PKU patients. QoL scores between classical and non-classical patients were also compared. Results: Data from 88 adult patients were analysed (66 had classical PKU). No median PKU-QoL score reached major or severe impact/frequent symptoms in any domain. The highest scores (meaning larger burden) were mostly related to emotional impact of PKU and disease management. When performing correlation analysis between Phe levels and QoL scores by all patients we found weak to fair positive correlation in several domains either short or long term. Patients with classical PKU reported greater financial impact of PKU than patients with less severe PKU. Classical PKU patients with good therapy adherence tended to report better HRQoL scores than patients with suboptimal adherence. Conclusion: We conclude that patients showed good HRQoL using the PKU-specific questionnaire. Our study demonstrates that suboptimal metabolic control is negatively associated with patients' HRQoL.

Project description:BACKGROUND: Phenylketonuria (PKU) is a chronic inborn error of amino acid metabolism that requires lifelong follow-up and intervention, which may represent strains on Quality of Life (QoL). This observational study evaluated QoL in a cohort of PKU patients, using updated and detailed instruments. METHODS: 22 patients with mild PKU respondent to BH4 and 21 patients with classical PKU treated with diet were recruited in this study. Adult patients completed WHOQOL questionnaire-100 (WHOQOL-100) and pediatric patients the Pediatric QoL inventory (PedsQL(TM)). Psychiatric and mood disorders were also evaluated using TAD or BDI and STAI-Y inventories. A multivariable linear regression model was fitted to investigate the predictors of QoL, including age, sex, treatment type, length of current treatment, educational level and employment status (only for adults) as covariates. Results were presented as regression coefficients with 95% confidence interval. RESULTS: Global QoL scores were within normal range both in patients with mild and classical disease but global QoL scores were significantly higher in patients with mild PKU under BH4 treatment as compared to those affected by classical disease who were under diet regimen. Furthermore, QoL significantly increased in long treated PKU patients. Among adult patients, QoL scores were significantly lower in males, in patients with lower education and in those employed or unemployed as compared to students (baseline). CONCLUSIONS: Both diet and medical treatment based upon BH4 seem to be associated with higher QoL in the long run. However, patients with mild PKU can rely on BH4 to achieve a higher Phe tolerance and a better compliance to therapy due to diet relaxation/avoidance. Some specific categories of patients with a lower QoL should be investigated more in depth, engaging with those at risk of lower treatment compliance. The questionnaires employed in the present study seemed to be able to effectively detect criticalities in QoL assessment and represent an advance from previous inventories employed in the past.

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Using a quality of life (QoL)-monitor: preliminary results of a randomized trial in Dutch patients with early breast cancer.

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Using a quality of life (QoL)-monitor: preliminary results of a randomized trial in Dutch patients with early breast cancer.

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