Quality of Life Research最新文献

Purpose/objectives

NRG/RTOG 0436 evaluated cetuximab added to chemoradiation (CRT) for non-operative esophageal cancer management. PRO objectives assessed improvement in the FACT-Esophageal cancer subscale (ECS), version 4, with cetuximab, and if improved ECS correlated with clinical complete response (cCR).

Materials/methods

Patients were randomized to cisplatin/paclitaxel/radiation ± cetuximab. Overall survival (OS) was the primary endpoint, with a 420 patient target, which also provided 82% power to detect ≥ 15 increase in the proportion of cetuximab patients with ECS improvement from baseline to 6–8 weeks post-CRT; α = 0.05, using a χ² test. Improvement in ECS and its Swallowing and Eating Indices (SI, EI) was defined as 5, 4 and 2 point increases, respectively, from baseline to 6–8 weeks post-CRT. Univariate logistic regression assessed if cCR was associated with improved ECS.

Results

This study was stopped early for not meeting a pre-specified OS endpoint and did not show survival benefit. Of 420 planned patients, 344 enrolled and 281 consented to PROs. ECS was completed by 261 (93%) at baseline, 173 (66%) 6–8 weeks post-CRT, and 117 (64%) at 1 year. At 6–8 weeks, patients receiving CRT + Cetuximab didn’t have improved ECS; they experienced a lower proportion of improvement compared to standard CRT (37% vs. 53%; P = 0.04). The proportion of CRT patients with improvement in SI was 9% higher than with cetuximab, but not statistically significant (39% vs. 30%, P = 0.22). There was no association between treatment and EI. When examining ECS scores at 1 year by cCR vs. residual disease, a higher proportion of cCR patients improved, but not statistically significant (48% vs. 45%, P = 0.74).

Conclusions

The addition of cetuximab to CRT for the nonoperative management of esophageal cancer did not improve PROs.

Purpose: Symptom management among patients diagnosed with advanced cancer is a high priority in clinical care that often involves the support of a family caregiver. However, limited studies have examined parallel patient and caregiver symptom burden and associations with their own and each other's quality of life (QOL). This study seeks to identify patient and caregiver symptom clusters and investigate associations between identified clusters and demographic, clinical, and psychosocial factors (cognitive appraisals and QOL).

Methods: This study was a secondary analysis of self-reported baseline survey data collected from a randomized clinical trial of 484 adult advanced cancer patients and their caregivers. Latent class analysis and factor analysis were used to identify symptom clusters. Bivariate statistics tested associations between symptom clusters and demographic, clinical, and psychosocial variables.

Results: The most prevalent symptom for patients was energy loss/fatigue and for caregivers, mental distress. Low, moderate, and high symptom burden subgroups were identified at the patient, caregiver, and dyad level. Age, gender, race, income, chronic conditions, cancer type, and treatment type were associated with symptom burden subgroups. Higher symptom burden was associated with more negative appraisals of the cancer and caregiving experience, and poorer QOL (physical, social, emotional, functional, and overall QOL). Dyads whose caregivers had more chronic conditions were more likely to be in the high symptom burden subgroup.

Conclusion: Patient and caregiver symptom burden influence their own and each other's QOL. These findings reinforce the need to approach symptom management from a dyadic perspective.

Purpose: Very little is known about the subjective well-being (SWB) of adults with a congenital corpus callosum disorder (CCD), the extent to which they feel satisfied with their lives, and what might be helpful in improving their SWB and quality of life. This study measured SWB among Australian adults with a CCD and compared the results with normative data for the wider Australian adult population.

Methods: Online surveys were completed independently by 53 Australian adults with a CCD. Data included demographic profiles and answers to questions about satisfaction with life, employing the Personal Wellbeing Index (PWI) and one open ended question. Domains measured included life as a whole, standard of living, health, achieving in life, personal relationships, safety, community connectedness and future security. The PWI results were statistically analysed and means compared with Australian normative data. The qualitative data were analysed using deductive thematic analysis.

Results: Australian adults with a CCD responded with ratings significantly below what might be expected of the adult Australian population in all domains except for standard of living and safety. Quantitative analysis results were supported by qualitative thematic analysis, expressing particular challenges and barriers to feeling satisfaction with life as a whole, personal relationships, achieving in life, health and future security.

Conclusion: Evidence from the PWI and accompanying qualitative responses indicate that SWB of Australian adults with CCD is significantly reduced compared with the general population. Further research is needed to examine the lived experience and explore solutions for support of this community.

Purpose: This study aimed to examine the psychometric performance of the EQ-5D-5L in informal caregivers of people with dementia.

Methods: Data were obtained from an online survey administered to informal caregivers of people with dementia in Australia. Known-group comparisons were examined by formulating 15 a priori hypotheses, where a difference was made between weak and strong hypotheses. Group comparisons were tested using the non-parametric Wilcoxon-rank and the Kruskal-Wallis test, as well as regression analysis. Floor and ceiling effects were considered to be present if more than 15% of respondents achieved the lowest or highest possible score, respectively.

Results: In total, 212 informal caregivers of people with dementia were included in the analysis. On average, participants were 47 years old (SD: 17) and 61% of them were female. The mean EQ-5D-5L utility score was 0.88 (SD: 0.16) and the mean EQ-VAS was 72.47 (SD: 17.86). While there was no floor effect, 26% reported full health. Nine strong and three weak hypotheses were confirmed, supporting the ability of the EQ-5D-5L to discriminate between groups with respect to: self-reported health status, happiness levels, presence of mental or physical health conditions, ability to engage in enjoyable activities, and availability of support.

Conclusion: Findings provide supporting evidence for the EQ-5D-5L in terms of its discriminant validity in informal caregivers of patients with dementia. However, the present ceiling effect suggests that the sensitivity of the EQ-5D-5L to detect improvements may be limited. Further studies are warranted examining other psychometric criteria, including reliability and responsiveness to change.

Purpose: The Functional Assessment of Cancer Therapy item (FACT-GP5) has the potential to provide an understanding of global treatment tolerability from the patient perspective. Longitudinal evaluations of the FACT-GP5 and challenges posed by data missing-not-at-random (MNAR) have not been explored. Robustness of the FACT-GP5 to missing data assumptions and the responsiveness of the FACT-GP5 to key side-effects are evaluated.

Methods: In a randomized, double-blind study (NCT00065325), postmenopausal women (n = 618) with hormone receptor-positive (HR+), advanced breast cancer received either fulvestrant or exemestane and completed FACT measures monthly for seven months. Cumulative link mixed models (CLMM) were fit to evaluate: (1) the trajectory of the FACT-GP5 and (2) the responsiveness of the FACT-GP5 to CTCAE grade, Eastern Cooperative Oncology Group (ECOG) Performance Status scale, and key side-effects from the FACT. Sensitivity analyses of the missing-at-random (MAR) assumption were conducted.

Results: Odds of reporting worse side-effect bother increased over time. There were positive within-person relationships between level of side-effect bother (FACT-GP5) and severity of other FACT items, as well as ECOG performance status and Common Terminology Criteria for Adverse Events (CTCAE) grade. The number of missing FACT-GP5 assessments impacted the trajectory of the FACT-GP5 but did not impact the relationships between the FACT-GP5 and other items (except for nausea [FACT-GP2]).

Conclusions: Results support the responsiveness of the FACT-GP5. Generally speaking, the responsiveness of the FACT-GP5 is robust to missing assessments. Missingness should be considered, however, when evaluating change over time of the FACT-GP5.

Trial registration: NCT00065325.

Trial registration year: 2003.

Purpose: We provide an initial description and validation of some public domain patient-reported outcome (PRO) items to assess cancer symptom burden to address immediate barriers to symptom assessment use in clinical practice and facilitate future research.

Methods: We created the Open Symptom Framework (OSF), a flexible tool for clinical cancer-related symptom assessment. The items comprise six components: recall period, concept, symptom, qualifier(s), a definition, and a 5-point Likert-type response. We recruited patients receiving cancer therapy in the United States and United Kingdom. We assessed external construct validity by comparing OSF scores to the PRO-CTCAE measure and assessed reliability, scalability, dimensionality, and item ordering within a non-parametric item response theory framework. We tested differential item functioning for country, age, gender, and level of education.

Results: We developed a framework alongside clinical and psychometric experts and debrieifed with 10 patients. For validation, we recruited 331patients. All items correlated with the PRO-CTCAE equivalents (r = 0.55-0.96, all p < 0.01). Mokken analysis confirmed the scalability and unidimensionality of all symptom scales with multiple items at the scale (Ho = 0.61-0.75) and item level (Hi = 0.60-0.76). Items are interpreted consistently between demographic groups (Crit = 0 for all groups).

Conclusion: The public domain OSF has excellent psychometric properties including face, content, and criterion validity and can facilitate the development of flexible, robust measurements to fulfil stakeholder need. The OSF was designed specifically to support clinical assessment but will function well for research. Further work is planned to increase the number of symptoms and number of questions per symptom within the framework.

Purpose: Patient-report outcome measures (PROMs) have gained widespread support as a mechanism to improve healthcare quality. We aimed to map out key enablers and barriers influencing PROMs implementation strategies in routine clinical practice.

Methods: An umbrella review was conducted to identify reviews exploring enablers and barriers related to the integration of PROMs in routine clinical practice from January 2000 to June 2023. Information on key enablers and barriers was extracted and summarised thematically according to the Theoretical Domains Framework.

Results: 34 reviews met our criteria for inclusion. Identified reviews highlighted barriers such as limited PROMs awareness among clinicians and patients, perceived low value by clinicians and patients, PROMs that were too complex or difficult for patients to complete, poor usability of PROMs systems, delayed feedback of PROMs data, clinician concerns related to use of PROMs as a performance management tool, patient concerns regarding privacy and security, and resource constraints. Enablers encompassed phased implementation, professional training, stakeholder engagement prior to implementation, clear strategies and goals, 'change champions' to support PROMs implementation, systems to respond to issues raised by PROMs, and integration into patient pathways. No consensus favoured paper or electronic PROMs, yet offering both options to mitigate digital literacy bias and integrating PROMs into electronic health records emerged as important facilitators.

Conclusions: The sustainable implementation of PROMs is a complex process that requires multicomponent organisational strategies covering training and guidance, necessary time and resources, roles and responsibilities, and consultation with patients and clinicians.

Objectives: To describe the health-related quality of life (HRQoL), estimate the associated health state utility values (HSUVs) and explore factors associated with HRQoL of patients with anxiety and/or depression in a resource-limited hospital setting.

Methods: A cross-sectional survey involving 462 participants was conducted in a hospital setting. The Amharic version of the EQ-5D-5 L assessed HRQoL, while the GAD-7 and PHQ-9 measured severity of anxiety and depression symptoms respectively. HSUVs were analysed based on clinical and demographic profiles; mean differences were compared using t-tests and one-way ANOVA; Scheffe's post hoc comparisons and effect sizes (Cohen's d statistic) were used to assess the magnitude of group differences. Factors associated with HRQoL were explored using regression analysis.

Results: The mean HSUV was 0.87 (SD = 0.17) and the EQ VAS was 71.4 (SD = 19.1). Patients with both anxiety and depression scored significantly lower (HSUV = 0.83 [0.16], EQ VAS = 64.4 [17.9]) compared to those with either anxiety only (HSUV = 0.88 [0.17], EQ VAS = 75.3 [17.9]) or depression only (HSUV = 0.89 [0.18], EQ VAS 74.4 [19.7]). Males had slightly higher mean scores than females, while those aged 18-35 years demonstrated the highest scores on both the EQ-5D-5 L and EQ VAS. Older age (β=-0.002), higher PHQ-9 scores (β=-0.008) and comorbid hypertension (β=-0.07) associated with lower HSUVs. Lower EQ VAS scores were associated with being female (β=-4.4), having comorbid hypertension (β=-7.4) and higher PHQ-9 scores (β=-0.86), while a positive association was found with having 'more than enough' income (β = 11.8).

Conclusions: Older age, severity or co-diagnosis of anxiety or depression and comorbid conditions were associated with lower HRQoL, highlighting the need for better interventions to improve the HRQoL of patients with anxiety and depression in Ethiopia.