Quality of Life Research最新文献

Purpose: To identify and evaluate the psychometric properties of available patient-reported outcome measures (PROMs) of psychological birth trauma (PBT) in postpartum women.

Methods: A literature search was carried out across eight databases-PubMed, Embase, Web of Science, CINAHL, PsycINFO, China National Knowledge Infrastructure (CNKI), Wanfang Database, and VIP Database for Chinese Technical Periodicals-covering studies published from the inception of each database up to 21 May 2024. English and Chinese language studies employing any research design and reporting at least one psychometric property of PBT in puerperae were included. Independent reviewers extracted data and followed the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines to evaluate three aspects of the included instruments: methodological quality, psychometric properties, and level of evidence assessed using the modified Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework.

Results: Thirty-one studies with twelve PROMs were included, measurement error, cross-cultural validity, and responsiveness were not reported for most PROMs. Nine PROMs received a Class B recommendation, based on their measurement attribute ratings and overall evidence quality. In contrast, the CTI, IES-R, and PBTAS with high-quality evidence for insufficient measurement properties, so received a Class C recommendation.

Conclusions: This systematic review provisionally recommends the City BiTS as credible tool for assessing PBT in both clinical practice and research involving puerperae. However, further comprehensive studies are needed to conduct more comprehensive validations of the psychometric properties of existing PROMs.

Purpose: The role of qualitative research in response-shift research has not been well characterized. This scoping review summarizes the status of qualitative studies on response shift.

Methods: A scoping review of the medical literature was done using the keywords "response shift" and "qualitative" or "interview." After excluding ineligible works, each retained article was rated by two independent raters according to the modified Critical Appraisal Skill Program (CASP) criteria. A synthesis of adjudicated review results further characterized the articles.

Results: The search yielded 50 unique articles published from 1991 to 2023, 39 of which were retained after applying exclusion criteria. Most (69%) had the highest possible CASP score. Studies involved a broad range of patients by diagnosis or therapeutic context, caregivers, and healthcare professionals. While studies were often purely descriptive, many addressed components of response-shift theory or assumptions of response-shift methods. Study goals varied by design, time-focus (i.e., retrospective, present-focus or prospective), and by whether response-shift hypotheses were planned or post-hoc. The theoretical value added by the qualitative process involved examining the cognitive/emotional processes underlying quality-of-life ratings and response shifts. The methodological value added by the qualitative process facilitates understanding measurement error and non-responsiveness, and whether the methods used reflect the researchers' presumptions.

Conclusion: The use of qualitative methods in response-shift research yields a nuanced understanding of what response-shift "looks like" in different patient populations, thereby helping to translate results more directly to clinical experience. Studies contributed to response-shift theory or methods in ways not easily captured by purely quantitative research.

Purpose: This study aimed to document utility values and the Visual Analog Scale (VAS) with the 5-level version of the EQ-5D questionnaire in a large sample of patients with inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC).

Methods: QALY-MICI was a cross-sectional survey across three sources in France. Data were collected between 2019 and 2022 for patients 18 and over. The EQ-5D-5 L, the EQ-VAS, the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), the Harvey-Bradshaw Index (HBI) for CD, and the Walmsley Index for UC (SCCAI) were collected.

Results: A total of 2,841 patients aged over 18 were recruited (1785 with CD, 1056 with UC). The mean age was 40.2 (SD 14.3). The time since diagnosis was 6 years and over for 61.9% of patients. The most impacted dimensions were usual activities, anxiety/ depression, and pain/ discomfort. The mean utility value was 0.863 (SD 0.172) versus 0.905 (SD 0.158) in the French population (p = 0.007). The mean VAS value was 68 (SD 19.2) versus 73.4 (SD 22.2) in the general population (p = 0.016). Utility values and VAS were similar for CD and UC and higher for men. There was a strong positive correlation between utility values, the VAS, and the SIBDQ score, and a negative correlation between the HBI and the SCCAI. The SIBDQ score and disease activity were the main predictors of utility and VAS.

Conclusion: The QALY-MICI is, to our knowledge, the first study documenting utility values and VAS using the EQ-5D-5 L questionnaire on a large sample, with a comparison to the general population.

Purpose: This cross-sectional survey study quantified the humanistic burden of immunoglobulin A nephropathy (IgAN), in terms of physical and mental health-related quality of life (HRQoL) and work productivity, among adults with primary IgAN and their care-partners.

Methods: HRQoL was assessed (01/31/22 - 05/31/23) with validated tools including the KDQoL-36 (with SF-12), GAD-7 (anxiety), PHQ-9 (depression), and WPAI: SHP (work productivity). Participant characteristics and total/domain scores were summarized; selected outcomes were compared to an external, kidney disease-free cohort.

Results: 117 adults with IgAN and their care-partner pairs, and one adult without a care-partner, were included. The mean ages of patients and care-partners were 38.0 (SD: 8.6) and 40.2 (11.8) years, respectively; 55.9% and 43.6% were female. Mean physical and mental SF-12 scores for patients were 46.7 (SD: 8.0) and 41.9 (9.2), respectively, and 50.7 (7.3) and 43.7 (10.24) for care-partners. Both SF-12 components for patients, and the mental component for care-givers, were significantly worse compared to the US general population. Among patients, 27.1% had moderate/severe anxiety and 49.2% reported at least moderate depression. Compared to external controls, patients experienced significantly higher severity of anxiety (6.6 vs. 5.4) and depression (8.1 vs. 6.6; both p < 0.0001). Among care-partners, 13.7% experienced moderate anxiety and 37.8% experienced moderate/moderately-severe depression. Among employed individuals, both groups reported IgAN-related absenteeism (8.8-9.4%), presenteeism (25.1-25.9%), and overall work impairment (30.4-30.5%).

Conclusion: US adults with IgAN and their care partners experience impairments to mental and physical HRQoL and heightened levels of depression and anxiety, underscoring the need for effective IgAN therapies and care-partner support.

Purpose: For patients with celiac disease (CeD), the only current management option is adherence to a strict gluten-free diet (GFD); however, many patients on a GFD continue to experience symptoms with a significant impact on quality of life. Potential new treatments for CeD are under development and a validated patient-reported outcome measure is required to evaluate their utility in clinical trials. The purpose of this article is to provide a history of the development of the Celiac Disease Symptom Diary (CDSD) 2.1^© for use in clinical trials.

Methods: Qualitative and quantitative studies were conducted from 2010 to 2021, including concept elicitation and cognitive debriefing interviews with adult and adolescent participants with CeD (N = 93) diagnosed via biopsy and/or serology and input from eight interviews with CeD clinical experts. During these studies, different iterations of the CDSD were presented to the US Food and Drug Administration and the European Medicines Agency, and modifications were made in line with their feedback.

Results: These studies ultimately led to the development of CDSD 2.1^©, a daily diary which focuses on key symptoms of CeD (abdominal pain, bloating, diarrhea, nausea and tiredness). This patient-reported outcome measure was readily understood by adult and adolescent participants with CeD and content validity was demonstrated in both populations.

Conclusion: CDSD 2.1^© is a content-valid patient-reported outcome measure developed in accordance with best practices and regulatory guidance. A thorough exploration of the psychometric properties of CDSD 2.1^© for both adult and adolescent participants with CeD is ongoing to support utilization in clinical trials.

Purpose: The EQ-5D has been used to assess health related quality of life (HRQoL) in respiratory conditions. However, the core descriptive system may not be sensitive to all the HRQoL impacts of these conditions. To increase the sensitivity of the descriptive system, two respiratory specific bolt-ons, have been developed. Psychometric assessment of the bolt-ons in comparison to other validated instruments is required to facilitate their use. Therefore, the aim of this study is to test the psychometric characteristics of the EQ-5D-5L + R using a large dataset collected in Australia.

Methods: A cross-sectional online survey was used to recruit adult respondents (≥ 18 years) representative of the Australian population. Descriptive and psychometric analyses were used to understand the performance of the EQ-5D-5L and bolt-ons in comparison to other validated instruments. The construct validity was estimated using correlations. Known-group validity was tested to determine the sensitivity of the instruments to differences across different severity groups.

Results: Overall 10,033 respondents (52% female) completed the survey, of which 300 had a respiratory condition. There were moderate to high correlation between bolt-ons with EQ-5D-5L and WHODAS. The EQ-5D-5L + bolt-ons slightly reduced the ceiling effect in comparison to the EQ-5D-5L. The effect size was larger for people with respiratory conditions than people who did not have a respiratory condition.

Conclusion: The results show that adding the respiratory bolt-on to the EQ-5D-5L might slightly improve the instruments descriptive sensitivity. The choice of bolt-on may be driven by whether overall problems or limitations are being measured.

Purpose: Arthrogryposis multiplex congenita (AMC) describes a heterogeneous group of rare congenital conditions. Health-related quality of life (HRQL) may be reduced in AMC due to broadly heterogeneous physical impairments and participation limitations. This study described HRQL in children and youth with AMC, compared HRQL between child self- and parent-proxy reports, and identified factors associated with better/worse HRQL.

Methods: Data on 205 children with AMC (age 8-21 years) from a North American AMC registry across eight hospital sites was used. HRQL was assessed cross-sectionally using the Patient Reported Outcome Measurement Information System (PROMIS) and European Quality of Life-5 Dimensions-Youth-3 Levels (EQ-5D-Y-3 L) by self-report, parent proxy-report or both.

Results: Mean child-reported PROMIS T-scores were significantly lower than the normal mean for the Upper Extremity (mean = 33.0) and Mobility (mean = 37.2) but in the normal range for Pain Interference (mean = 46.6) and Peer Relationships (mean = 51.7). A lot of problems in EQ-5D-Y-3 L was reported by 37% in Feeling Worried/ Sad/ Unhappy, 46% in Having Pain/Discomfort, 50% in Doing Usual Activities, 56% in Mobility, and 57% in Looking After Myself. Compared to child-report, parents reported significantly worse PROMIS T-scores and higher problems in EQ-5D domains. Wheelchair use, being small for gestational age, prolonged hospitalization after birth, increased number of orthopedic surgeries, and caregiver's stress were associated with lower HRQL scores.

Conclusion: Findings indicate the importance of considering both the child's and parents' reports of HRQL, and to provide multimodal interventions that focus on the effect of childhood and parental characteristics to promote HRQL among children with AMC.

Purpose: Family caregivers of care-dependent patients experience a decline in their Quality of Life (QoL). However, the determinants contributing to this decrease in QoL are still not fully understood. Therefore, this study aimed to estimate prospectively the determinants contributing to decreased QoL among family caregivers of care-dependent patients.

Methods: This longitudinal study involved 135 family caregivers in Brazil. Data were collected at baseline from October 2016 to August 2017, and at follow-up from December 2021 to July 2022. During both periods, we administered a questionnaire that covered sociodemographic, health, and lifestyle characteristics of the participants; the Barthel Index to assess the dependency level of the patients; and the WHOQOL-bref to assess the caregivers' QoL.

Results: Both caregivers and care-dependent patients were more frequently elderly (44.4% versus 74.6%), female (79.3% versus 61.5%), and had non-communicable disease (60.0% versus 94.3%) at baseline. Most patients experienced a worsening in their level of dependency (59.8%), while over a third of family caregivers (34.8%) reported a decline in their General Quality of Life Index. Eight determinants of decreased QoL were identified: four protective factors (religious faith, physical activity, sharing caregiving responsibilities, and sufficient sleep) and four risk factors (patient hospitalization in the past year, patient increased care dependency, older family caregiver age, and longer caregiving duration).

Conclusion: Many factors influencing caregiver QoL are modifiable through intervention, underscoring the need for public policies to support family caregivers. Healthcare professionals can play a vital role in promoting protective factors and addressing risk factors to enhance caregiver QoL.

Purpose: A substantial number of people experience a persisting impact on health-related quality of life (HRQoL) after COVID-19. The current study aims to identify different trajectories of physical and mental HRQoL, fatigue severity, and dyspnoea severity following hospitalisation with COVID-19, and associated factors of these trajectories.

Methods: 500 patients with COVID-19 were followed for one year in a longitudinal cohort study. Self-reported outcomes were measured at 3, 6, 9, and 12 months after hospitalisation. Distinct trajectories were characterised using Growth Mixture Modelling. Sociodemographic and clinical correlates of trajectories were investigated using multivariable (multinomial) logistic regression analyses.

Results: Three trajectories ('stable high' (16%), 'improving' (40%), and 'stable low' (44%)) were found for physical HRQoL, and four ('stable high' (43%), 'improving' (14%), 'middle declining' (17%), and 'low' (26%)) for mental HRQoL. Older age, overweight and obesity, lower education, and comorbidities were associated with 'low' physical HRQoL. Younger age was associated with 'low' mental HRQoL. Four fatigue trajectories ('no fatigue' (15%), 'improving' (40%), 'low-severe' (27%), and 'high-severe' (18%)) were found. Participants either experienced almost never ('no dyspnoea', 75%) or almost always ('severe', 25%) dyspnoea. High co-occurrences between low HRQoL and severe fatigue and dyspnoea symptom trajectories were found.

Conclusion: A substantial number of COVID-19 survivors continue to struggle with reduced HRQoL over time. However, large variations in these physical and mental HRQoL trajectories exist, and trajectories are associated with persisting COVID-19-related symptoms or pre-hospitalised health status. Regular measurement of HRQoL and post-COVID symptoms may help identify those that may benefit from timely interventions.

Purpose: Maxillofacial reconstruction with dental implants in microvascular tissue flaps aims to improve mastication. However, the quality of life (QoL) impact of this intervention is yet to be determined. This systematic review assessed the QoL impact of maxillofacial reconstruction with implant-supported teeth compared to no dental rehabilitation, removable dentures, and obturator (modified denture). Additionally, we examined instruments applied to measure QoL in maxillofacial reconstruction.

Methods: Databases Ovid Medline and Embase, Scopus, Web of Science and Handle on QoL were searched. Cohort, case-control and randomized controlled trials (RCT) were narratively synthesized for QoL captured through validated instruments. Study methodological quality was assessed using Cochrane Risk of Bias 2 and Risk of Bias in Non-randomized studies of Exposure. Instruments underwent COSMIN content validity analysis.

Results: Of a total of 2735 studies screened, the three included studies (two cohort and one RCT) showed improved QoL with maxillofacial reconstruction compared to obturator and no dental rehabilitation. However, these studies have high risk of bias due to confounding. None of the instruments achieved a sufficient relevance rating for maxillofacial reconstruction, having been designed for other target populations and there is no evidence on their content validity for this population, but the EORTC QLQ30 H&N35 satisfied more COSMIN criteria than the UW-QOL and OHIP-14.

Conclusion: Although studies showed favourable QoL with maxillofacial reconstruction involving dental implants, these have high risk of bias and further studies are needed to establish the impact. Existing QoL instruments lack content validity and tailored instruments are needed for QoL evaluation in maxillofacial reconstruction.