Health and Quality of Life Outcomes最新文献

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 .

Background: The patient voice in healthcare continues to grow, through the expanded use of patient-reported outcomes (PRO) and enhanced by the growing use of digital health technologies. Despite these positive signs, widespread adoption of PRO measures (PROM) in healthcare decision-making continues to lag. We conducted a scoping review to identify the current benefits of and roadblocks to the use of PRO data in the patient-clinician interaction.

Methods: We searched the Embase and MEDLINE databases from 2014 to 2024 for articles that discussed the role of PRO data in patient quality of life, clinical care and value assessment decision-making. We also manually searched the websites of nine national health technology assessment agencies and used a snowballing approach to identify additional publications. Eligible publications were mapped to three key topics of interest: benefits/barriers at the patient, clinician, and healthcare service levels.

Results: Our search yielded 1,846 citations; after deduplication and screening, 13 articles were included. At the patient level, benefits included increased care satisfaction and improved patient experience, mainly via enhanced communication. Uncertainty about PROMs and their mechanisms was a main barrier, as were concerns about the variability of clinical application, lack of follow-up, and unfulfilled patient expectations. For clinicians, improved patient symptom clarity, satisfaction with care, and informed decision-making were the main benefits of PROMs, along with improved efficiency during patient visits. The main barrier for physicians was the feasibility of integrating PROMs into daily practice, including establishing the routine use of PROMs, and consistency in the interpretation of PRO data. At the healthcare service level, improvements in efficiency and the identification of unmet needs were benefits, while questions about consistent between-group interpretation were raised, as were questions regarding the basic value of PROMs, as there is currently minimal evidence to indicate that PRO data directly improve care outcomes.

Conclusion: Much evidence exists indicating PROMs are associated with improvements in patient-clinician communication and improved satisfaction on both parts, although hesitation regarding their widespread adoption remains. More objective data are needed to further quantify the potential benefits of PROM integration in clinical care in order to assess any direct impact on clinical care outcomes and to facilitate their broader use.

Background: Amyotrophic Lateral Sclerosis (ALS) is a rapidly progressive, life-limiting neurodegenerative disease. Informal carers provide extensive support, significantly impacting their health-related quality of life (HRQoL). Current HRQoL measurement using person-reported outcome measures (PROMs) in ALS carers lacks consistency and comprehensiveness, hindering robust assessment and synthesis. There is evident need for a comprehensive conceptual framework of HRQoL, to fully capture the multidimensional nature of caregiving in ALS. Such a framework is essential to inform research and clinical practice, ensuring relevant measurement and meaningful clinical discussions. This study aimed to develop this evidence-based framework.

Methods: This study comprised two stages. Firstly, a scoping review was undertaken in March 2024 using Medline, Embase, and CINAHL to identify primary articles exploring HRQoL in ALS carers. Qualitative, mixed methods and quantitative articles using multi-item PROMs to assess HRQoL in informal ALS carers were included. Relevant themes and subthemes were extracted from articles and PROMs and mapped onto an existing conceptual framework for people with ALS (Quality of Life in ALS, QuALS), which covers physical, psychological, and social HRQoL domains in people with ALS. The Carer-QuALS framework was subsequently developed and refined using existing literature and consultation with ALS carers. PROMs within this review were then indexed against the finalised Carer-QuALS framework.

Results: From 715 search results, 82 articles and 44 PROMs were eligible for inclusion. One new subtheme 'physical caring activities' emerged, while seven subthemes lacked support from the literature. In three structured consultation sessions, nine ALS carers, reviewed the draft Carer-QuALS framework (consisting of seven themes and 43 subthemes). Based on their input, one new subtheme 'privacy' was added, six subthemes were removed, and one was retained, despite lacking support from review literature. The final Carer-QuALS framework includes 37 subthemes: 8 physical, 6 social, and 23 psychological.

Conclusions: This review presents a comprehensive conceptual framework encompassing the multidimensional impact of ALS caregiving on the HRQoL of informal carers. The framework provides a resource that can be used by researchers, clinicians, and patient advocacy groups for multiple purposes (e.g., to support PROM selection to measure HRQoL, to guide future PROM development, and to facilitate discussions between informal carers and clinicians).

Background: When the increasing prevalence of Smartphone Addiction (SA) and its potential negative effects on mental health among adolescents are taken into consideration, an in-depth investigation of the relationship between SA and Psychological Well-being (PW) is of critical importance. Therefore, using a three-wave longitudinal research design, this study aimed to examine the serial mediation role of Psychological Flexibility (PF) and Emotion Regulation (ER) in the relationship between SA and PW. To our knowledge, this is the first study to examine SA, PF, ER, and PW relationships and mediating mechanisms in an adolescent sample using a longitudinal design.

Methods: The study included 448 adolescents (49.8% female and 50.2% male; Range_age = 15-19, M_age = 16.76, SD_age = 1.12) who responded to the questionnaires in three waves. Participating adolescents responded to a 50-item questionnaire consisting of the Smartphone Addiction Scale-Short Version (SAS-SV), the Five-Dimensional Well-Being Scale for Adolescents (EPOCH), the Multidimensional Psychological Flexibility Inventory Short Form (MPFI-SF), and the Regulation of Emotions Questionnaire (REQ). The questionnaires were filled in using pen and paper in a classroom environment under the supervision of the teacher and the researcher.

Results: Compared to those who used their smartphones for 0-2 h and 2-4 h, adolescents who reported to use their smartphones for more than four hours daily were found to have higher SA scores and lower PW, ER, and PF scores across all three time points (T1, T2, and T3). The findings indicated that SA at T1 negatively predicted PW at T3 (β = -0.34, p < .001), PF at T2 (β = -0.39, p < .001), and ER at T2 (β = -0.23, p < .001). On the other hand, PF at T2 positively predicted ER at T2 (β = 0.17, p < .001) and PW at T3 (β = 0.40, p < .001), and ER at T2 positively predicted PW at T3 (β = 0.73, p < .001). Besides, PF at T2 (β = -0.15, SE = 0.03, 95% CI = [-0.2036, -0.1053]) and ER at T2 (β = -0.17, SE = 0.03, 95% CI = [-0.2288, -0.1054]) were found to fully mediate the longitudinal relationship between SA at T1 and PW at T3. The longitudinal serial mediation model accounted for 32% of the variance in PW (R² = .32).

Conclusions: This study shows that SA leads to a decrease in adolescents' PF skills and their capacity to effectively manage their emotional reactions over time, which in turn leads to lower PW levels. The findings emphasize the potential of interventions to improve PF and ER skills in alleviating SA-related mental health problems in adolescents. The findings also suggest that both strengthening PF and ER skills separately and addressing them simultaneously could significantly increase the effectiveness of treatment approaches.