Health and Quality of Life Outcomes最新文献

Background: Liver cirrhosis (LC) significantly impairs health-related quality of life (HR-QoL) due to physical, psychological, and nutritional challenges. Despite its growing burden in India, limited evidence exists on how disease severity, alcohol dependence, and malnutrition influence HR-QoL in Indian LC patients.

Methods: This cross-sectional study included 565 LC patients attending a tertiary care hospital over 30 months. HR-QoL was assessed using SF-36. Disease severity was graded using the Child-Turcotte-Pugh (CTP) score, while nutritional status and alcohol dependence were evaluated using the RFH-NPT and AUDIT tools. Associations were analysed using Pearson's correlation, ANOVA, and logistic regression.

Results: The mean age of participants was 42.5 ± 14.9 years; 81.9% were male, and 58.6% resided in rural areas. Malnutrition was present in 80.9% of patients, and 50.6% were alcohol-dependent. Patients with severe liver cirrhosis (CTP Class C) had significantly lower HR-QoL scores across all domains (p < 0.001). Malnutrition was associated with higher odds of severe liver cirrhosis (OR 1.53; 95% CI: 1.27-1.85), and lower physical function scores were also significantly associated with disease severity (OR 0.89; 95% CI: 0.89-0.95). Severe cirrhosis was additionally marked by elevated serum bilirubin and INR levels, and reduced albumin concentrations.

Conclusion: HR-QoL declines substantially with worsening cirrhosis, especially in malnourished and alcohol-dependent patients. These findings highlight the need for multidisciplinary interventions focusing on nutrition, lifestyle modification, and psychological support to improve outcomes in LC patients.

Background: Dermatologic toxicities are common among metastatic colorectal cancer (mCRC) patients receiving epidermal growth factor receptor inhibitors (EGFRIs), adversely affecting their well-being and quality of life (QoL). Currently, no validated tool exists in China to measure these symptoms. This study validated the Simplified Chinese version of the Functional Assessment of Cancer Therapy-EGFRI 18 (FACT-EGFRI-18-sC) for QoL assessment in mCRC patients.

Methods: A cross-sectional study was performed via convenience sampling to recruit mCRC patients from two tertiary hospitals in Shenyang, China. Sample size adequacy was confirmed by post hoc power analysis (G*Power 3.1; >80% power for r ≥ 0.3, α = 0.05). Acceptability was assessed by item-level missing data. Reliability was evaluated by Cronbach's α and a 2-week test-retest intraclass correlation coefficient (ICC). Criterion validity was evaluated against the Simplified Chinese version of the patient-reported version of CTCAE (PRO-CTCAE-sC) through non-parametric analyses. Construct validity was assessed via correlations with the Simplified Chinese Body Image Scale (BIS-sC), Karnofsky Performance Status (KPS), and cetuximab cycles using Spearman tests. Diagnostic accuracy and cutoff value were determined via receiver operating characteristic (ROC) analysis.

Results: The final sample (n = 184) provided sufficient statistical power, with post hoc analysis revealing 98% power (α = 0.05) to detect correlations exceeding 0.3. The FACT-EGFRI-18-sC showed excellent acceptability (no missing data) and satisfactory reliability (Cronbach's α = 0.899, ICC = 0.875). Moderate to strong negative correlations with PRO-CTCAE-sC (r = -0.436 to -0.803, p < 0.001) and significant FACT-EGFRI-18-sC score differences by dermatologic toxicity status (Z = -4.823 to -7.457, p < 0.001) supported criterion validity. Scores of the FACT-EGFRI-18-sC correlated negatively with BIS-sC (r = -0.565 to -0.619, p < 0.001), positively with KPS physical/functional subscales (r = 0.424/0.541, p < 0.001), but not with the social/emotional subscale (r = 0.125, p > 0.05), confirming construct validity. ROC analysis yielded an area under the curve (AUC) of 0.844 and identified an optimal cutoff of 60.00.

Conclusions: The validated FACT-EGFRI-18-sC is a robust tool for QoL assessment in mCRC patients experiencing EGFRI-related dermatologic toxicities, providing a standardized measure to guide toxicity management.

Introduction: Herpes zoster (HZ), affecting 14.9 million people aged ≥ 50 globally in 2020, imposes a growing burden in aging populations due to its association with chronic pain, psychological distress, and socioeconomic disparities. This study aimed to evaluate health-related quality of life (HRQoL) among people with HZ and explore its socioeconomic and clinical determinants in China.

Methods: We conducted a cross-sectional survey to investigate the HRQoL of 2,566 herpes zoster patients across seven Chinese cities using the EQ-5D-5 L and VAS-100 instruments. Multivariate linear regression models quantified the association of age, income, insurance type, herpes zoster related pain, complications, and comorbidities with HRQoL.

Results: The average EQ-5D score was 0.83, and the average VAS score was 71.49 among herpes zoster patients in China. Patients aged ≥ 70 years exhibited the most severe decline in both EQ-5D (β = -0.110, p < 0.01) and VAS-100 scores (β = -8.811, p < 0.01), with mobility limitations (OR = 3.696, p < 0.01) and self-care deficits (OR = 2.295, p < 0.01) disproportionately affecting this group. Herpes zoster related pain was associated with lower HRQoL (EQ-5D:β = -0.126, p < 0.01). Patients with comorbidities faced significant HRQoL reductions (VAS: β = -4.014, p < 0.01).

Conclusion: Our study found that Chinese herpes zoster patients exhibited higher HRQoL scores compared to those reported in most of other studies. Advanced age, lower education levels, inadequate insurance coverage, and pain occurrence were all significantly associated with diminished HRQoL. The observed disparities in HRQoL reductions among patient subgroups highlight the need to address health equity through curative interventions and preventive strategies.

Background: The heterogeneity of patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs) in published clinical studies on vaginal relaxation syndrome (VRS) hinders cross-study comparisons and integration of evidence-based findings, impeding the development of robust clinical evidence.

Objective: To comprehensively investigate the current use of PROs and PROMs in VRS research, compile a comprehensive catalog, and provide guidance for selecting outcome measures and tools VRS patients.

Methods: This study systematically searched clinical studies on VRS treatment published up to December 2024 in PUBMED, EMBASE, Web of Science, and Cochrane databases, focusing primarily on pelvic floor muscle training, physical energy therapies, and surgical interventions. PROs and PROMs were extracted, organized into a structured catalog, and categorized by thematic domains. The COSMIN checklist was applied to assess the measurement properties of commonly used PROMs.

Results: A total of 69 studies were included, comprising 14 randomized controlled trials (1193 patients) and 55 observational studies (3327 patients), totaling 4520 participants. These studies reported 68 PROs and 57 PROMs. The most commonly used PROMs were the Female Sexual Function Index (FSFI, 47.83%), Vaginal Laxity Questionnaire (VLQ), Visual Analog Scale (VAS), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), and Sexual Satisfaction Questionnaire (SSQ). Notably, 42 PROMs (73.68%) appeared only once.

Conclusions: PROs for surgical and non-surgical VRS treatments are similar, but non-surgical interventions include additional outcomes, such as overall efficacy and patient's vaginal tightness satisfaction. The high proportion of unvalidated PROMs (81.09%) underscores the need for standardized, disease-specific measures. Future Delphi surveys and expert consensus are anticipated to facilitate the development of a comprehensive core outcome set (COS) and core outcome measurement set (COMS) for VRS.

Background: COVID-19 has affected millions globally, with a significant proportion experiencing long-COVID and impaired health-related quality of life (HRQoL). This systematic review and meta-analysis aimed to synthesize the existing literature on HRQoL in COVID-19 patients.

Methods: We conducted a systematic search of PubMed, Embase, Web of Science, Scopus, and the Cochrane Library for studies published between December 2019 and March 2025. Eligible studies were peer-reviewed and assessed HRQoL in COVID-19 patients using the EQ-5D instrument. Study quality and risk of bias were evaluated using the Newcastle-Ottawa Scale. Pooled health utility values were estimated using a random-effects model, and heterogeneity was assessed via I² statistics. Predictors of poor HRQoL were qualitatively narrated.

Results: Out of 3539 references, 187 studies with 116,525 participants were analyzed. The majority (80.2%) used the EQ-5D-5 L version. The pooled mean EQ-5D utility score was 0.76 (95% CI 0.74-0.79, I² = 99.9%) while the mean EQ-5D Visual Analogue Scale (VAS) score was 70.76 (95% CI 68.48-73.04; I² = 99.7%). Pain/discomfort and anxiety/depression were the most affected domains, reported by 51% and 46% of patients, respectively. Subgroup analysis showed significant differences in HRQoL based on national income status (p = 0.038) and geographic region (p < 0.001). Common predictors of lower HRQoL included older age, female gender, disease severity, comorbidities, and post-COVID-19 symptoms.

Conclusion: This systematic review demonstrates a substantial reduction in HRQoL among COVID-19 patients compared to the general population. The pooled utility values of COVID-19 contribute to understanding patients' HRQoL and can assist in calculating Quality-Adjusted Life Years. This provides essential data for future economic evaluations and informs health policy decisions.

Background: Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a debilitating, long-term illness that significantly impairs physical functioning. Despite its impact, the use of modern generic instruments to assess physical function in this population remains underexplored. This study aims to assess the psychometric properties of the Patient-Reported Outcome Measurement Information System^® (PROMIS) Physical Function Short Form (PF-SF) 12a for use in adults with ME/CFS.

Methods: This study included 334 participants (173 with ME/CFS and 161 healthy controls) who took part in a Cognitive and Exercise sub-study of the Multi-Site Clinical Assessment of ME/CFS study from six clinics across the US. Data was used to examine the ceiling/floor effects, internal consistency reliability, known-groups validity, and convergent validity of the PROMIS PF-SF.

Results: The mean T-score of the PROMIS PF-SF was 40.5 for participants with ME/CFS, about one standard deviation below the national norm (T-score = 50). The PROMIS PF-SF showed no substantial floor/ceiling effects and high internal consistency (standardized Cronbach's α = 0.88 and ω = 0.92). In addition, this instrument showed good known-groups validity with medium-to-large effect sizes (η² = 0.08-0.35). A significant, monotonic increase of the physical function score was found across ME/CFS participant groups with low, medium, and high functional impairment as defined by four different measures. Participants with ME/CFS had significantly worse physical function scores than healthy controls (η² = 0.70). The PROMIS PF-SF also demonstrated good convergent validity with high correlations (magnitude of r = 0.47-0.55) with other relevant measures.

Conclusions: The PROMIS PF-SF 12a demonstrated satisfactory reliability and validity for use in ME/CFS research and clinical practice.

Background: Health related quality of life (HRQoL) in paediatric patients with inflammatory bowel disease (IBD) is typically measured using the patient reported outcome measure IMPACT-III. This measure has not yet been validated for German patients using the new 4-domain structure. As Germany has a comparatively high prevalence of paediatric IBD and as the IMPACT-III is the main HRQoL outcome measure in use, a validation in the German population is overdue.

Objective: To validate the main patient reported outcome measure of health-related quality of life (HRQoL) in paediatric patients with inflammatory bowel disease (IBD) IMPACT-III in a German patient sample.

Methods: Clinical and HRQoL data was gathered in the CEDATA-GPGE registry. To determine the psychometric performance of the IMPACT-III in a German sample, distribution properties, reliability (Cronbach's alpha) and validity (correlations with clinical values; known-groups validity by age, sex, and self-rated health) were calculated. In addition, a confirmatory factor analysis was performed to determine the appropriateness of the factor structure.

Results: The IMPACT-III was filled out by 221 patients (Female 46%; M_age=14.05; Morbus Crohn n = 126; Ulcerative Colitis n = 79; unclassified IBD n = 18). The total score ranged from 19.29 to 95.00, without the occurrence of ceiling or floor effects. Internal consistency using Cronbach's alpha was excellent (α = 0.91) for the total scale. The total score correlated strongly with the subscales of wellbeing (r = 0.90) and social functioning (r = 0.80). Concerning validity, the subscale of wellbeing correlated with self-reported health and clinical assessments. Younger patients (< 14) reported a significantly better HRQoL than older patients (14-17). The 4-domain structure of IMPACT-III could not be confirmed through factor analysis.

Conclusions: The German version of the IMPACT-III is a valid and reliable instrument to measure HRQoL in paediatric patients with IBD. The subscales of well-being and social functioning explain most of the total score. To interpret the subdomains of the IMPACT-III further research in a longitudinal design needs to be done, especially with age-related phrasing of the items.

Trial registration: German Clinical Trials Register DRKS00015505. Registered on 22.01.2019 Inclusion of patients 01.03.2019; https://drks.de/search/en/trial/DRKS00015505 .