Estimating Cost-Effectiveness Using Alternative Preference-Based Scores and Within-Trial Methods: Exploring the Dynamics of the Quality-Adjusted Life-Year Using the EQ-5D 5-Level Version and Recovering Quality of Life Utility Index

ObjectivesThis study aimed to explore quality-adjusted life-year (QALY) and subsequent cost-effectiveness estimates based on the more physical health–focused EQ-5D 5-level version (EQ-5D-5L) value set for England or cross-walked EQ-5D 3-level version UK value set scores or more mental health recovery-focused Recovering Quality of Life Utility Index (ReQoL-UI), when using alternative within-trial statistical methods. We describe possible reasons for the different QALY estimates based on the interaction between item scores, health state profiles, preference-based scores, and mathematical and statistical methods chosen.MethodsQALYs are calculated over 8 weeks from a case study 2:1 (intervention:control) randomized controlled trial in patients with anxiety or depression. Complete case and with missing cases imputed using multiple-imputation analyses are conducted, using unadjusted and regression baseline-adjusted QALYs. Cost-effectiveness is judged using incremental cost-effectiveness ratios and acceptability curves. We use previously established psychometric results to reflect on estimated QALYs.ResultsA total of 361 people (241:120) were randomized. EQ-5D-5L crosswalk produced higher incremental QALYs than the value set for England or ReQoL-UI, which produced similar unadjusted QALYs, but contrasting baseline-adjusted QALYs. Probability of cost-effectiveness <£30 000 per QALY ranged from 6% (complete case ReQoL-UI baseline-adjusted QALYs) to 64.3% (multiple-imputation EQ-5D-5L crosswalk unadjusted QALYs). The control arm improved more on average than the intervention arm on the ReQoL-UI, a result not mirrored on the EQ-5D-5L nor condition-specific (Patient-Health Questionnaire-9, depression; Generalized Anxiety Disorder-7, anxiety) measures.ConclusionsReQoL-UI produced contradictory cost-effectiveness results relative to the EQ-5D-5L. The EQ-5D-5L’s better responsiveness and “anxiety/depression” and “usual activities” items drove the incremental QALY results. The ReQoL-UI’s single physical health item and “personal recovery” construct may have influenced its lower 8-week incremental QALY estimates in this patient sample.     

Residential greenness and risks of depression: Longitudinal associations with different greenness indicators and spatial scales in a Finnish population cohort

We carried out a longitudinal study on the associations between residential greenness and depression risk in urban areas in Finland. Residential greenness indicators were estimated within various buffer sizes around individuals' home locations (selected n = 14424) using time-series of normalized differential vegetation index (NDVI) and CORINE land cover data (CLC). We estimated individuals’ cumulative exposure to residential greenness over a 5-years and 14-years follow-up. We used doctor-diagnosed depression and Beck Depression Inventory for depression assessment. Our multi-logistic model showed an inverse association between residential greenness and depression, implying lowered depression risk for individuals with higher residential greenness. The association was particularly evident when using NDVI-based residential greenness (within a buffer of 100 m radius) and doctor-diagnosis depression data, adjusted with individual-level covariates. The odds ratio was 0.56 (95% CI 0.33 to 0.96) for the 5-years follow-up, and 0.54 (95% CI 0.30 to 0.98) for the 14-years follow-up. The associations between CLC-based total residential green space and depression varied across the different buffer sizes. In general, all the associations depended on the type of depression assessment, quality of greenness indicators, and the spatial scale of analysis. The associations also varied across the socio-demographic groups and neighborhood socioeconomic disadvantage level.     

Validation of the Modena bleeding score in endoscopic sinus surgery

IntroductionThe Modena bleeding score is a categorical rating scale that allows the assessment of the surgical field in relation to bleeding during endoscopic surgery. It has recently been presented and validated in the field of endoscopic ear surgery by the present authors. The Modena bleeding score provides five grades for rating the surgical field during endoscopic procedures (from grade 1 ? no bleeding to grade 5 ? bleeding that prevents every surgical procedure except those dedicated to bleeding control).ObjectiveThe aim of this study was to validate the Modena bleeding score in the setting of endoscopic sinus surgery.MethodsFifteen three-minute videos of endoscopic sinus surgery procedures (each containing three bleeding situations) were evaluated by 15 specialists, using the Modena bleeding score. Intra and inter-rater reliability were assessed, and the clinical validity of the Modena bleeding score was calculated using a referent standard.ResultsThe data analysis showed an intra-rater reliability ranging from 0.6336 to 0.861. The inter-rater reliability ranged from 0.676 to 0.844. The clinical validity was α = 0.70; confidence limits: 0.64 ? 0.75, corresponding to substantial agreement.ConclusionThe Modena bleeding score is an effective method to score bleeding during endoscopic sinus surgery. Its application in future research could facilitate the performance and efficacy assessment of surgical techniques, materials or devices aimed to bleeding control during endoscopic sinus surgery.     

Pain in desmoid-type fibromatosis: Prevalence,determinants and prognosis value

The aim of this study is to evaluate the prevalence, determinants and prognostic value of pain at diagnosis in patients with desmoid-type fibromatosis (DF). We selected patients from the ALTITUDES cohort (NCT02867033), managed by surgery, active surveillance or systemic treatments, with pain assessment at diagnosis. Patients were invited to fill QLQ-C30 questionnaire and Hospital Anxiety Depression Scale. Determinants were identified using logistic models. Prognostic value on event-free survival (EFS) was evaluated using the Cox model. Overall, 382 patients were included in the current study (median age: 40.2 years; 117 men). The prevalence of pain was 36%, without significant difference according to first-line treatment (P = .18). In the multivariate analysis, pain was significantly associated with tumor size >50 mm (P = .013) and tumor site (P < .001); pain was more frequent in the neck and shoulder locations (odds ratio: 3.05 [1.27-7.29]). Pain at baseline was significantly associated with poor quality of life (P < .001), depression (P = .02), lower performance status (P = .03) and functional impairment (P = .001); we also observed a nonsignificant association with anxiety (P = .10). In the univariate analysis, baseline pain was associated with poor EFS; the 3-year EFS was 54% in patients with pain compared to 72% in those without pain. After adjustment for sex, age, size and line of treatment, pain was still associated with poor EFS (hazard ratio: 1.82 [1.23-2.68], P = .003). One third of recently diagnosed patients with DF experienced pain, especially those with larger tumors and neck/shoulder locations. Pain was associated with unfavorable EFS after adjustment for the confounders.     

Impact of Adding Oseltamivir to Usual Care on Quality-Adjusted Life-Years During Influenza-Like Illness

ObjectivesThe ALIC⁴E trial has shown that oseltamivir reduces recovery time while increasing the risk of nausea. This secondary analysis of the ALIC⁴E trial aimed to determine the gain in quality-adjusted life-years (QALYs) associated with adding oseltamivir to usual primary care in patients presenting with influenza-like illness (ILI).MethodsPatients with ILI were recruited during the influenza season (2015-2018) in 15 European countries. Patients were assigned to usual care with or without oseltamivir through stratified randomization (age, severity, comorbidities, and symptom onset). Patients’ health status was valued with the EQ-5D and visual analog scale (VAS) for up to 28 days. Average EQ-5D and VAS scores over time were estimated for both treatment groups using one-inflated beta regression in children (<13 years old) and adults (≥13 years old). QALY gain was calculated as the difference between the groups. Sensitivity analysis considered the value set to convert EQ-5D answers to summary scores and the follow-up period.ResultsIn adults, oseltamivir gained 0.0006 (95% confidence interval 0.0002-0.0010) QALYs, whereas no statistically significant gain was found in children (14-day follow-up, EQ-5D). QALY gains were statistically significant in patients aged ≥65 years, patients without relevant comorbidities, or patients experiencing symptoms for ≤48 hours. Using VAS and accounting for 28-day follow-up resulted in higher QALY gain.ConclusionsQALY gain owing to oseltamivir is limited compared with other diseases, and its clinical meaningfulness remains to be determined. Further analysis is needed to evaluate whether QALY gain and its impact on ILI treatment cost render oseltamivir cost-effective.     

瘀热型慢性前列腺炎与心理性因素及性功能的相关性

目的分析瘀热型慢性前列腺炎(CP)临床症状与心理性因素及性功能的相关性。方法收集2020年6月至2021年6月在南京市江宁中医院泌尿外科门诊诊治的91例瘀热型CP患者的临床资料进行回顾性分析,使用美国国立卫生研究院慢性前列腺炎症状指数评分表(NIH-CPSI)、中医证候量表、7项广泛性焦虑障碍量表(GAD-7)、抑郁症筛查量表(PHQ-9)、疼痛灾难化量表(PCS)、国际勃起功能评分表(IIEF-5)和早泄诊断量表(PEDT)对患者进行评估,对量表评定结果进行Pearson相关性分析和多元线性回归分析。结果(1)症状量表:NIH-CPSI总分与中医量表总分、GAD-7总分呈正相关,中医证候量表总分与CPSI、GAD-7、PHQ-9、PCS、PEDT总分呈正相关(P<0.05);CPSI总分随中医量表总分递增而升高,中医证候量表总分随CPSI疼痛症状、PHQ-9总分递增而升高(P<0.05)。(2)情绪量表:GAD-7总分与CPSI、中医证候量表总分、排尿症状、PHQ总分、PEDT总分呈正相关,PHQ-9总分与中医证候量表总分、疼痛及排尿症状、PCS总分、PEDT总分呈正相关,PCS总分与中医证候量表总分及疼痛症状分值呈正相关(P<0.05);GAD-7总分随PHQ-9总分递增而升高;PHQ-9总分随中医证候量表排尿症状、GAD-7、PCS分值递增而升高;PCS总分随中医证候量表疼痛症状、PHQ-9分值递增而升高(P<0.05)。(3)性功能量表:IIEF-5总分与中医证候量表疼痛分值呈负相关,PEDT总分与中医证候量表总分及疼痛症状、GAD-7、PHQ-9分值呈正相关(P<0.05);IIEF-5总分随中医证候量表疼痛症状分值递减而升高(P<0.05)。结论瘀热型CP患者表现为以疼痛为主,伴随排尿异常、情绪异常、认知障碍和性功能障碍的系列症状,同时使用中医证候量表及CPSI评估能较好的反映其病情的严重程度。     

妊娠晚期孕妇抑郁情绪对新生儿神经行为发育的影响

目的探讨妊娠晚期孕妇抑郁情绪对新生儿神经行为发育的影响。方法选取2017年1月—2018年12月,收治本院的160例妊娠晚期孕妇抑郁情绪患者一般临床资料,妊娠周期28周以上,对孕妇抑郁情绪进行统计采用爱丁堡抑郁自评量表、负性认知加工偏向量表,对新生儿神经行为进行评估时按照婴儿神经国际量表。结果160例妊娠晚期孕妇抑郁情绪患者中,阳性30例、阴性130例,与阴性妊娠妇女相比,抑郁阳性妊娠妇女负性沉思偏向、负性解释偏向、负性记忆偏向、负性注意偏向均显著较高,差异具有统计学意义(P<0.05)。160例新生儿中,婴儿神经国际量表评分处于临界值为60例,正常值为100例,神经行为异常发生率为37.50%,负性沉思偏向、负性注意偏向与婴儿神经国际临界值呈负相关关系(P<0.05);与抑郁自评量表无明显相关性(P>0.05)。结论妊娠晚期孕妇具有较高抑郁发生率,其中负性认知加工偏向中负性沉思偏向、负性注意偏向与新生儿神经行为发育具有明显相关性。