Patient Related Outcome Measures最新文献

Purpose: The primary objective of this study is to assess the feasibility of administering an online meditation program compared to usual care to glaucoma patients to improve mental health outcomes such as quality of life, depression, anxiety, and sleep quality. The secondary objective of this study is to improve mental health outcomes among glaucoma patients.

Patients and methods: This is a study protocol for a 12-week randomized control trial employing a mixed methods design. Glaucoma patients will be recruited from the Ivey Eye Institute in St. Joseph's Hospital Center. Eligible patients will include glaucoma patients of at least 75 years of age. Consented participants will be randomized to an online meditation group or usual care group in blocks of 4, or 2 per arm. Patients assigned to the online meditation group will undergo guided meditation sessions led by a meditation instructor via Microsoft Teams. Patients randomized to the usual care arm will undergo their usual glaucoma treatment. All study questionnaires including feasibility metrics, SF-12, CES-D, HADS-A and PSQI will be administered to both treatment groups at week 1, week 3, week 6, and week 12. Following study conclusion, feasibility metrics will be sent to participants in the intervention arm. In addition, patients randomized to the usual care arm will be given the opportunity to enroll in the meditation program after the 12 week study period, but no data will be collected.

Discussion and conclusion: To the best of the authors' knowledge, this study is the first of its kind to assess the feasibility of administering an online meditation intervention to glaucoma patients. If the findings from this study demonstrate positive results in favor of the treatment, this will be used to justify larger clinical trials and eventually, the integration of online meditation into the standard of care for glaucoma patients.

Purpose: Iron deficiency anemia (IDA) affects approximately 5 million people in the United States (US), significantly impacting quality of life (QoL) and overall health. Iron stores can be replenished through oral iron or, if ineffective/poorly tolerated, through intravenous iron (IVI) therapy. Despite IVI effectiveness, patients do delay/miss infusion appointments, leading to incomplete treatment response. Here we evaluated multiple-dose IVI therapy logistics and adherence from the patient perspective.

Patients and methods: US adult patients (≥18 years) with confirmed IDA who were currently prescribed an IVI treatment course were asked to respond to a 46-question online survey in early 2023. Questions covered patient demographics, appointment logistics, IVI infusion experience, impact of infusion on daily activities, reason(s) for missing any doses, and considerations for improving adherence.

Results: A total of 323 patients completed the survey, 193 of whom were prescribed ≥2 IVI infusions per month. Of these patients, 71/193 (36.8%) reported missing at least one dose, despite its effectiveness at improving symptoms. Most patients (122/193 [64.3%]) agreed that multiple-dose IVI therapy adversely impacted their QoL by reducing their productivity (63.4%) and attendance at important events (64.8%), with 80.3% reporting having to schedule their life around therapy. A third of patients (73/193 [38.1%]) were unsatisfied with their infusion frequency, with most (163/193 [84.5%]) agreeing that fewer IVI infusions would improve adherence, and most also (174/193 [90.1%]) preferring a single-dose option if available.

Conclusion: Time spent arranging and receiving multiple IVI infusions per month can interfere with patients' daily activities, leaving them dissatisfied with their IVI treatment experience. In this study, single-dose IVI infusions were a preferred option for patients with IDA, which may improve adherence to the complete course of treatment and offer improved QoL. Therefore, patient preference, convenience, and satisfaction should be considered and discussed when determining the type of IVI treatment.

Purpose: Myopia is a global public health issue, estimated to affect 50% of the world's population by 2050. Evidence suggests that reducing myopia by one diopter decreases the risk of myopia-related retinal complications by 40%. Despite the availability of several myopia control methods, their clinical adoption remains limited. To improve their uptake, enhancing parental awareness of myopia control is crucial. This study explores parental awareness of myopia-related complications, control interventions and their perspectives on myopia management in France and the UK.

Patient and methods: A structured survey was conducted among 200 self-selected parents of children with myopia (100 France, 100 UK), via the TOM app, an online platform for tracking medication adherence. The survey assessed parental understanding of myopia complications, awareness of control strategies, perspectives on management, and financial concerns.

Results: 74% of French and 88% of the UK parents reported being aware of at least one myopia-related long-term complication, with cataract the most recognized in France (66%) and glaucoma in the UK (76%). 50% of French and 43% of UK parents were unsure or unaware that myopia progression could be slowed. UK parents reported higher adoption rates of myopia control methods, including orthokeratology (47% France, 68% UK), atropine (46% France, 63% UK), and red-light therapy (44% France, 67% UK). Financial burden was a significant concern, with 59% of French and 52% of UK parents feeling strained by costs, particularly for glasses, contact lenses, and specialized treatments. Parents of children with faster myopia progression (>-1 dioptres/year) were more likely to report financial stress (p<0.001).

Conclusion: While most parents are aware of myopia complications, notable gaps exist in understanding control options. UK parents adopted control methods more frequently than French parents. Financial burden remains a significant concern, emphasizing the need for enhanced parental education and affordable access to myopia control.

Purpose: The Emotional Well-Being Questionnaire (EWQ) assesses a broad spectrum of mental health conditions and related symptoms-depression, anxiety, asthenia, and insomnia-highly relevant in type 2 diabetes (T2D), where emotional distress can impair adherence and outcomes. This pilot cross-sectional study provides preliminary validation evidence for the EWQ six-factor model in a T2D cohort using confirmatory factor analysis (CFA), evaluating reliability and convergent validity for mental-health screening.

Patients and methods: A sample of 240 adults (T2D n = 122; control n = 118) with T2D completed the EWQ and nine-item Patient Health Questionnaire (PHQ-9). Confirmatory factor analysis (CFA) was conducted to assess the six-factor model fit, and convergent validity was evaluated through analysis of EWQ scores with PHQ-9 scores.

Results: Confirmatory factor analysis indicated acceptable-borderline fit for a pilot sample (CFI = 0.886; TLI = 0.883; RMSEA = 0.071), providing preliminary support for the six-factor structure. The EWQ demonstrated reliability in the T2D group (Cronbach's α = 0.79). Convergent validity was supported by a significant positive correlation with PHQ-9 scores (r = 0.652, p < 0.001), confirming the EWQ's capacity to assess depressive symptoms in this population.

Conclusion: The EWQ's six-factor structure showed preliminary adequacy in adults with T2D. While internal consistency and convergent validity with the PHQ-9 were supportive, overall model fit indices were moderate; therefore, findings should be interpreted with caution and replicated in larger, more diverse samples before clinical implementation. Future studies should focus on cross-cultural validation, measurement invariance, and longitudinal assessment to refine its clinical utility.

Background: Residual low back pain (LBP) is frequently reported after percutaneous kyphoplasty (PKP) for osteoporotic vertebral fractures (OVFs), yet its underlying mechanisms remain unclear. Paravertebral muscles (PVMs) degeneration, particularly fat infiltration and atrophy may contribute to persistent postoperative pain.

Objective: To evaluate the association between PVMs degeneration and residual LBP after PKP and identify imaging-based predictors for risk stratification.

Methods: This retrospective cohort study included 213 patients (mean age 70.88 ± 8.58 years; 82.2% female) with single-level OVFs who underwent PKP between January 2021 and June 2023. Patients with multiple-level fractures, chronic LBP, neurological deficits, prior spinal surgery, incomplete imaging, or inadequate follow-up were excluded. Fat infiltration percentage (FI%) and cross-sectional area of the multifidus (MF), erector spinae (ES), and psoas major (PS) were measured at the L4 level using transverse T2-weighted MRI. Residual LBP was defined as postoperative VAS ≥3.5 at 12-month follow-up. Logistic regression and ROC analyses were conducted and appropriate univariate tests (t-test or Mann-Whitney U-test) were performed.

Results: Residual LBP occurred in 13.6% of patients and was associated with higher VBQ scores (3.14 ± 0.38 vs 2.57 ± 0.25, P=0.001), greater postoperative kyphosis (16.03 ± 6.69° vs 6.70 ± 4.80°, P=0.001), increased FI% of ES/MF (57.28 ± 5.63% vs 43.40 ± 14.93%, P=0.001), reduced PS area (10.74 ± 4.23 cm² vs 16.15 ± 3.71 cm², P=0.001), and concentrated cement distribution (11.5% vs 73.6%, P=0.001). Independent predictors included elevated VBQ (OR=85.2, 95% CI 7.006-1036.458), kyphosis (OR=1.14, 95% CI 1.017-1.276), FI% of ES/MF (OR=1.082, 95% CI 1.008-1.160), and PS area (OR=0.509, 95% CI 0.285-0.910). ROC analysis identified FI% ≥49.78% and PS area ≤11.937 cm² as optimal cutoffs.

Conclusion: Preoperative magnetic resonance imaging assessment of paravertebral muscle may help identify patients at risk for residual low back pain after kyphoplasty. Incorporating preoperative imaging and postoperative physical therapy referral may improve patient outcomes.

Background: Stroke outcomes are often measured through objective scales, which may neglect subtle cognitive changes and fail to capture patients' subjective experiences of recovery and quality of life. This study aimed to examine the interrelations among self-perceived burden, loneliness, and rumination in stroke survivors through the patient-reported outcomes and to provide theoretical insights and intervention strategies for improving psychological well-being and quality of life in stroke patients.

Methodology: Data from 1024 stroke patients who aged 18 years and above were prospectively collected in September 2022 in Zhengzhou, China. PROs included Self-Perceived Burden Scale, UCLA-Loneliness Scale, and Event-Related Rumination Inventory. Statistical methods employed included correlation analysis and mediation effect analysis.

Results: A total of 1024 participants completed this survey (90.9%), with 56.2% males and a mean age of 62.22 (SD = 13.60) years. Approximately 84.28% of stroke patients felt moderate loneliness. Self-perceived burden was positively correlated with rumination (r = 0.516, 95% CI [0.460, 0.574]) and loneliness (r = 0.370, 95% CI [0.307, 0.431]). Rumination was also positively associated with loneliness (r = 0.493, 95% CI [0.443, 0.541]). Both intrusive and deliberate rumination served as mediators in the relationship between SPB and loneliness (b = 0.119, 55.09%, b = 0.031, 14.35%, respectively).

Conclusion: Intrusive and deliberate rumination mediated the relationship between self-perceived burden and loneliness in stroke patients. Rumination in stroke patients should be emphasized as a modifiable factor to reduce loneliness and improve quality of life.

Objective: The objective of this pilot study was to examine the agreement between child self- and parent proxy-assessment of health-related quality of life (HRQoL) in spinal muscular atrophy (SMA) in the era of disease-modifying therapy.

Methods: Children with SMA and one of their parents were recruited via the German national TREAT-NMD SMA patient registry. HRQoL was measured using the Pediatric Quality of Life Inventory 3.0 Neuromuscular Module (PedsQL 3.0 NMM), KIDSCREEN-27, and the Health Utilities Index (HUI). Agreement between child self- and parent proxy-ratings of ordinal measures was estimated using Cohen's κ, and for continuous measures using intraclass correlation coefficients (ICCs) from one-way random-effects models.

Results: The final sample comprised 17 children with SMA (mean age: 9.88 years, SD: 4.33 years, range: 5-16 years; 59% female) and one of their parents. All but two patients (88%) were receiving disease-modifying therapy (nusinersen or risdiplam). The ICC for the total PedsQL 3.0 NMM score was estimated at 0.85 (95% CI: 0.64-0.94, p < 0.001) (indicative of excellent agreement). The corresponding estimate for the KIDSCREEN total score was 0.27 (95% CI: 0.00-0.75, p = 0.197) (poor/fair agreement) and the global HUI utility 0.98 (95% CI: 0.93 to 0.9952, p < 0.001) (excellent agreement). The lowest levels of concordance were found for school and family life, as well as mental well-being, as opposed to physical functioning and disability.

Conclusion: We show that the agreement between child self- and parent proxy-reports of HRQoL in SMA varies markedly across HRQoL measures and examined domains, ranging from poor/fair to excellent. Compared with previous research, agreement for the PedsQL 3.0 NMM was markedly higher in our contemporary cohort of patients treated with novel therapies. These preliminary findings will be helpful in informing the design of future research of HRQoL in SMA.

Purpose: Patient-reported outcome measures (PROMs) are relevant for assessing the bond between a mother and her child, both before and after childbirth. Several questionnaires have been developed with the Mother-to-Infant Bonding Scale (MIBS) prominent among them, as it is a valid and easy-to-administer questionnaire owing to its length. Even though, this PROM has been adapted in Japanese, Indonesian and Swedish, it remains to be translated into French. The objective of this study was to translate and cross-culturally adapt the MIBS into French (MIBS-Fr).

Patients and methods: The translation and cultural-adaptation of the questionnaire were performed following a 10-step process as recommended by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). During the cognitive debriefing, each item of the questionnaire was rated between 1 to 10 according to the comprehension level by 11 mothers.

Results: The French version was very well understood with a mean level of comprehension of 9.7 ± 1.4 out of 10. The one-word descriptor used to express feelings in the original version was replaced by phrases in the French version for a better language adaptation. Slight modifications were made by the original developer, and back translations were found to be very consistent.

Conclusion: This study reports the development of a French version of the MIBS (MIBS-Fr) following the ISPOR's recommendations for the translation and intercultural adaptation of a questionnaire. The MIBS-Fr provides French-speaking healthcare professionals with a practical and standardized tool to assess mother-to-infant bonding, facilitating early identification of bonding difficulties and supporting appropriate interventions in postpartum care.

Purpose: Good health status has traditionally been linked to greater levels of patient satisfaction. With the emergence and integration of various medical modalities, including Homeopathy, Ayurveda, and other complementary and alternative medical treatments, patients are likely to have different satisfaction levels during their interaction with different practitioners. Amidst this diversity, the efficacy, accessibility, and cost-effectiveness of these treatment approaches have garnered significant attention. Hence, a tool was developed to assess the patient's interaction with Complementary and Alternative Medicine treatments specifically Homeopathy. The objective of this study is to evaluate the validity and reliability of the Patient Satisfaction Assessment Tool (PSAT) developed to assess patient interaction with homeopathic outreach services.

Methods: A new structured questionnaire was developed using a standardized procedure. After obtaining clearance from the scientific and ethics committee of the Central Council for Research in Homoeopathy, data was collected from consenting participants above 18 years of age attending the Dr. D.P. Rastogi Central Research Institute for Homoeopathy, Noida, Uttar Pradesh, India. Data was then computerized and analyzed by principal component analysis as the extraction method and orthogonal varimax as the rotation method.

Results: A total of 285 participants were enrolled for psychometric validation, and 254 participants were included in the final analyses after exclusion. The mean (±Standard Deviation) age of participants was 37.63 (±12.9) years (range 18-79). The final 34-item questionnaire was arranged into nine domains as per rotated component matrix analysis. The overall internal consistency of the final questionnaire, as calculated by Cronbach's alpha, was 0.79, and the measure of sampling adequacy was 0.85 (Kaiser-Meyer-Olkin test).

Conclusion: Initial results from the pilot tests suggest that Patient Satisfaction Assessment Tool (PSAT) is effective in capturing key aspects of patient satisfaction, from homeopathic clinical services which can guide future quality improvement initiatives in alternative medicine healthcare facilities.