Health and Quality of Life Outcomes最新文献

Background: To maintain good standards of care, evaluations of policy interventions or potential improvements to care are required. A number of quality of life (QoL) measures could be used but there is little evidence for England as to which measures would be appropriate. Using data from a pilot Minimum Data Set (MDS) for care home residents from the Developing resources And minimum dataset for Care Homes' Adoption (DACHA) study, we assessed the discriminant construct validity of QoL measures, using hypothesis testing to assess the factors associated with QoL.

Methods: Care home records for 679 residents aged over 65 from 34 care homes were available that had been linked to health records and care home provider data. In addition to data on demographics, level of needs and impairment, proxy report measures of social care-, capability- and health-related QoL of participants were completed (ASCOT-Proxy-Resident, ICECAP-O, EQ-5D-5L Proxy 2). Discriminant construct validity was assessed through testing hypotheses developed from previous research and QoL measure constructs. Multilevel regression models were analysed to understand how QoL was influenced by personal characteristics (e.g. sex, levels of functional and cognitive ability), care home level factors (type of home, level of quality) and resident use of health services (potentially avoidable emergency hospital admissions). Multiple imputation was used to address missing data.

Results: All three QoL measures had acceptable construct validity and captured different aspects of QoL, indicated by different factors explaining variation in each measure. All three measures were negatively associated with levels of cognitive impairment, whilst ICECAP-O and EQ-5D-5L Proxy 2 were negatively associated with low levels of functional ability. ASCOT-Proxy-Resident was positively associated with aspects of quality and care effectiveness at both resident- and care home-level.

Conclusion: The study found acceptable construct validity for ASCOT-Proxy-Resident, ICECAP-O and EQ-5D-5L Proxy 2 in care homes, with findings suggesting the three are complementary measures based on different constructs. The study has also provided evidence to support the inclusion of these QoL measures in any future MDS.

Background: Atrial fibrillation (AF) stands as the most common cardiac arrhythmia on a global scale with a substantial symptom burden impacting the quality of life (QoL) of patients with AF. Consequently, assessing and monitoring symptoms in patients with AF has gained increased interest, leading to a rise in patient-reported outcome measures (PROMs). PROMs provide valuable insights into the patient's perspective, allowing for a more patient-centric approach to care. One of these PROMs is the Atrial Fibrillation Severity Scale (AFSS), a convenient and straightforward instrument for assessing symptom severity in patients with AF, potentially enabling healthcare professionals to tailor interventions accordingly. However, no Danish version of AFSS exists. This study aims to translate and linguistically validate the AFSS in accordance with MAPI Research Trust Guidelines.

Methods: The translation of AFSS from English to Danish was conducted using forward and backward translation, yielding versions 1 and 2, respectively. Afterwards, the translated AFSS was linguistically validated in patients with AF by cognitive interviews producing a third version. The third version was then proofread, finalizing the Danish version of AFSS.

Results: Derived from the cognitive interviews, the Danish version of AFSS demonstrated comprehensibility and readability among all included patients with AF. No revisions were deemed necessary based on the patient testing, culminating in the submission of the final version of AFSS for approval.

Conclusion: A certified and linguistically validated Danish version of the AFSS has been established and is accessible through MAPI Trust Research.

Background: Patient-reported outcome measures (PROMs) are crucial to capture patients' health and illness status. Selecting the most suitable PROM to measure self-reported health in a specific study population is essential. Shortcomings of much used generic instruments have been identified in certain populations, and more investigation is needed to clarify the extent to which the generic instruments capture the aspects of health that really matter to patients. Therefore, the aim of this study was to determine floor and ceiling effects of a generic health utility instrument (EQ-5D-5L) in an international multi-centre cohort of patients after percutaneous coronary intervention (PCI) and further explore those with perfect health scores by using a disease-specific instrument.

Methods: The CONCARD^PCI study was conducted at seven large referral PCI centres in Norway and Denmark between June 2017 and May 2020. In all, 2574 unique patients were available for this analysis. The generic EQ-5D-5L descriptive system and visual analogue scale, and the disease-specific Myocardial Infarction Dimensional Assessment Scale (MIDAS) comprising 35 items measuring seven areas of health status and daily life challenges were used to scrutinize the aims. Latent class analyses were conducted to identify classes with similar patterns of daily life challenges based on MIDAS item scores within the group of patients with best possible EQ-5D-5L score ('perfect scorers').

Results: There was a large ceiling effect on the EQ-5D-5L score in patients with coronary artery disease (CAD) with 32% scoring the best possible EQ-5D-5L score, suggesting perfect health. Latent class analysis on the MIDAS revealed, however, four classes where 17-46% of the perfect scorers did perceive challenges in health, particularly related to symptoms of fatigue, and worries about risk factors and side effects of medication.

Conclusion: To obtain an accurate picture of patients' health status, these results emphasize that both generic and disease-specific patient-reported outcomes measures are needed to capture the distinct problems that patients with CAD experience after PCI. Caution should be made when using the EQ-5D-5L as the sole measure, particularly in priority settings, due to its potential ceiling effect and the fact that important aspects of patient health may be neglected.

Trial registration: NCT03810612.

Background: Cancer treatment greatly impacts physical and psychological functioning of cancer patients, negatively affecting their quality of life (QoL). This Umbrella Review (UR) aims to systematically summarize psychological and social factors positively or negatively associated with QoL in cancer patients undergoing treatment.

Method: Four scientific databases (PubMed, Embase, Scopus, and PsycInfo) were searched to identify systematic reviews between 2012 and 2023 analyzing the relationship between QoL and psychosocial factors in cancer patients in treatment. The UR was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Joanna Briggs Institute (JBI) review guidelines. The methodological quality of the included studies was evaluated using Assessment of Multiple Systematic Reviews 2 (AMSTAR2).

Results: Eighteen systematic reviews were included. The major psychological factors influencing QoL are depression, coping strategies, anxiety, and distress. Results also demonstrate the significant impact of social factors on QoL: perceived social support has a positive influence on QoL of cancer patients, while lowered social support, impaired social functioning, interactions, and role limitations worsen their QoL and overall well-being.

Conclusion: This UR provides a comprehensive overview of the psychosocial factors impacting QoL of cancer patients and serves as a prominent base for developing questionnaires and policies aimed at measuring QoL in cancer patients undergoing treatment. Moreover, the findings of the study can guide future research or the development of personalized clinical interventions aimed at improving QoL for this cancer population group.

Background: Research on health-related quality of life (HRQOL) using minimally important differences for cancer care in Asian settings are sparse. This study aimed to describe functional HRQOL trajectories among Colorectal Cancer (CRC) patients undergoing adjuvant chemotherapy (AC) compared to those who did not (No AC), evaluate if AC was associated with change in HRQOL prospectively, and examine QOL differences between elderly and non-elderly CRC patients requiring AC.

Methods: CRC patients diagnosed between February 2018 to August 2021 were recruited from three Singapore public hospitals. Participants completed the EORTC QLQ-C30 over seven timepoints (diagnosis, predischarge, 1-, 3-, 6-, 9-, 12-months post-surgery). Clinical characteristics were collected from electronic medical records.

Results: The sample comprised 251 participants (102 in AC group; 40.64%). Clinically relevant deteriorations in functional HRQOL were observed in both groups between baseline and predischarge. These returned to baseline by 12-month. AC was associated with poorer physical (β = -35.34, p < 0.05) and role functioning (β = -71.17, p < 0.05) over time. Being elderly was associated with poorer physical functioning (β = -0.44, p < 0.05) over time. However, the non-elderly AC subgroup tended to experience poorer HRQOL in general compared to elderly.

Conclusions: Functional recovery remains a challenge for CRC patients in general. However, non-elderly AC patients may experience more severe impacts to role and social functioning.

Background: Patient-reported outcomes (PROs) are important clinical outcomes widely used as primary and secondary endpoints in clinical studies. However, PRO data often suffers from missing values for various reasons, which pose challenges to data analysis. This simulation study aimed to compare the performance of existing state-of-the-art approaches in handling missing PRO data.

Methods: Using a real and complete multiple-item PRO dataset, we generated various missing scenarios with different missing rates, mechanisms, and patterns. The performances of eight methods were compared, including a mixed model for repeated measures (MMRM) with and without imputation at the item level, multiple imputation by chained equations (MICE) at the composite score and item levels, and three control-based pattern mixture models (PPMs) and the last observation carried forward (LOCF) imputation at the item level.

Results: We found that the bias (i.e., deviation of the estimated from the true value) in the treatment effect estimates increased, and the statistical power diminished as the missing rate increased, especially for monotonic missing data. Item-level imputation led to a smaller bias and less reduction in power than composite score-level imputation. Except for cases under missing-not-at-random mechanisms (MNAR) and with a high proportion of patients' entire questionnaire missing, MMRM imputation at the item level demonstrated the lowest bias and highest power, followed by MICE imputation at the item level. The PPM methods were superior to the other methods under MNAR mechanisms.

Conclusions: PPMs imputation at the item level was preferable for MNAR, whereas MMRM and MICE imputation at the item level were better for other scenarios. These findings provide valuable insight for selecting appropriate methods for handling missing PRO data.

Background: The escalating globalization of health assessments underscores a pivotal challenge: Do Quality of Life (QoL) instruments, developed primarily in Western contexts, accurately reflect the perspectives of non-Western populations? This study evaluates the alignment of EQ-5D and EQ-HWB items with QoL dimensions identified in Chinese literature, and compares QoL perceptions between Chinese residents and those living abroad who may be influenced by Western values.

Methods: This study employed three successive rounds of participant recruitment to refine the concept mapping process. Initially, 13 bilingual QoL experts in the Netherlands piloted the methodology, providing feedback on item translation and expression. Subsequently, 18 Chinese expatriates in the Netherlands, with partial education abroad, reviewed the revised materials to represent perspectives influenced by Western culture. Finally, 20 native Chinese residents, who were born and educated in China, formed the target group. Utilizing feedback from the pilot stage, a pool of 54 QoL items derived from Chinese literature, plus an additional eight from the EQ-HWB, were assembled. The Group Concept Mapping (GCM) method was used, with participants organizing the items to reflect their interrelationships. Data were analyzed via Groupwisdom™, an online tool supporting multidimensional scaling (MDS) and cluster analysis, culminating in visual cluster rating maps that highlighted the item associations and groupings.

Results: In China, a five-cluster MDS map was identified: personal abilities, family and society, physical health, mental health, and self-cognition (stress value: 0.183), with physical health prioritized. Abroad, four clusters appeared: mental health, social connections, daily activities, and physical function (stress value: 0.185), prioritizing social connections. The EQ-5D missed the "family and society" cluster in China and "social connections" abroad. In contrast, the EQ-HWB covered all clusters in both groups.

Conclusions: The EQ-5D items align well with the somatic and partially with the mental clusters, while the EQ-HWB also covers the adaptation cluster and the remaining mental cluster aspects. Both instruments reflect the QoL perceptions of Chinese individuals, although EQ-5D focuses more on health than overall well-being. Cultural differences affect priorities: participants in China value physical health most, whereas those abroad emphasize social connections.

Purpose: To examine racial and ethnic disparities in Health-Related Quality of Life (HRQOL) in older adults with breast cancer, both pre- and post-diagnosis.

Methods: Using the SEER-MHOS database, we included patients ≥ 65 years old with breast cancer who completed the Health Outcomes Survey within 24 months pre- and post-diagnosis, and who were non-Hispanic White, non-Hispanic Asian or Pacific Islander, non-Hispanic Black or African American, or Hispanic. HRQOL data was measured via the Physical and Mental Component Summary (PCS, MCS). Univariable and multivariable linear regression models were fitted to assess for potential disparities between races and ethnicities.

Results: On univariable regression models, a numerical drop in mean scores of PCS and MCS was found among all racial/ethnic groups between pre- and post-diagnosis. Among patients in the pre-diagnosis cohort who would be diagnosed with stage IV breast cancer, race was found to be a predictor of PCS with overall significance (p = 0.04). On the local test, compared with Black individuals, White individuals had higher pre-diagnosis PCS scores (+ 13.32, p = 0.03). Race/ethnicity was not found to be a predictor in PCS or MCS scores otherwise.

Conclusion: Among older patients diagnosed with stage IV breast cancer, White individuals had better physical HRQOL than Black patients' pre-diagnosis. The decrease in the numerical HRQOL scores of the physical domain in all groups post-diagnosis highlights the potential negative physical impact of breast cancer has on patients, demonstrating the need for determining the proper resources and support to improve physical HRQOL following diagnosis.

Background: We sought to identify important issues regarding symptoms and impacts of obstructive sleep apnea (OSA), to explore fatigue and sleepiness, and evaluate the content, clarity, and relevance of specific patient reported outcome (PRO) measures.

Methods: Participants in the US with OSA and at least mild fatigue were studied. Individuals with positive airway pressure (PAP) therapy intolerance or current PAP refusal (non-PAP users) and those who initiated PAP within the past 12 months (PAP users) were identified and interviewed. Interviews included concept elicitation questions about symptoms and impacts of OSA. Participants then completed several PRO measures (the PRO Measurement Information System [PROMIS] Fatigue-8a, PROMIS Sleep-Related Impairment-8a, Epworth Sleepiness Scale [ESS], Patient-Global Impression of Severity of Fatigue [PGI-S Fatigue], and Patient Global Impression of Change in Fatigue [PGI-C Fatigue]) and were cognitively debriefed to evaluate their content, clarity, and relevance.

Results: A total of 30 individuals with OSA (20 non-PAP and 10 PAP) were enrolled. In addition to fatigue (reported by 100%), sleepiness (75%), difficulty concentrating (85%), dry mouth/throat (60%), headaches (50%) and interrupted sleep (50%) were the most common symptoms reported by non-PAP users. Fifty-eight percent of non-PAP users rated fatigue as the most bothersome symptom; 5% rated sleepiness as the most bothersome. Among PAP users, the most common symptoms (prior to PAP use) in addition to fatigue (100%) were sleepiness (90%), difficulty concentrating (60%), dry mouth/throat (60%), headaches (50%), and interrupted sleep (50%). Fatigue was rated as most bothersome by 56% of PAP users; sleepiness was rated as the most bothersome by 22%. All participants mentioned fatigue and sleepiness separately, indicating they are considered distinct symptoms. In general, participants found the PRO measures to be relevant and clear, and results supported their content validity, clarity, and relevance.

Conclusions: Fatigue was the most bothersome symptom reported by non-PAP and PAP users. Participants described fatigue as a distinct and different concept from excessive daytime sleepiness. Participants reported that their OSA symptoms negatively impact daily activities, functioning, work, and relationships. The PRO measures are clear and relevant for individuals with OSA and appropriate for use in both clinical and research settings.