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.     

Frequency of blood lactate elevation following esophagectomy and its association to postoperative complications

Background

Esophagectomy is a major surgical intervention and a cornerstone in the treatment of esophageal cancer. There is clinical experience that blood lactate concentration often is elevated in the period following esophagectomy, but the incidence and clinical consequences are sparsely studied.

Methods

We extracted data from all patients undergoing esophagectomy at Karolinska University Hospital 2016–2018, n = 153. Most were performed with minimally invasive technique, n = 130. Blood lactate values directly after surgery, highest value during the first night, and morning level on postoperative day one were recorded. Primary outcome was hospital length of stay and secondary outcome was a composite of postoperative infection, additional surgery, or intensive care during the hospital stay. Development of anastomotic leak was analyzed separately.

Results

Postoperative hyperlactatemia was common as 93% of patients had peak lactate concentration >1.6 mmol/L and 27% >3.5 mmol/L in the first night following operation. Median hospital length of stay was 14 days. Blood lactate showed a weak correlation to hospital stay and intensive care the morning following surgery, but not at arrival to postoperative ward. There were no statistical differences between those with and without anastomotic leak at any of the time points. Elevated lactate in the first 12–16 h postoperatively was related to surgical factors (open technique, surgery time, and perioperative bleeding) but not to patient related factors (ASA-class, Charlson comorbidity index, sex, age) or cumulative fluid balance.

Conclusion

In conclusion, elevated blood lactate in the immediate time following esophagectomy showed a weak association to intensive care and length of stay but not anastomotic leak.     

整体护理联合加速康复外科应用于小儿尿道下裂修复术的效果

目的探讨整体护理联合加速康复外科(ERAS)措施应用于小儿尿道下裂修复术的效果。方法选择2019年3月至2021年5月中山市博爱医院收治的80例尿道下裂修复术的患儿作为研究对象,按照随机数字表法将其分为参照组(40例)与实验组(40例)。参照组采取传统护理方案,实验组采取整体护理联合ERAS,比较两组干预后并发症发生率、满意度及下床活动时间、切口愈合时间、术后首次排便时间、住院时间,使用儿童疼痛评估量表(FLACC)评估患儿疼痛程度。结果实验组并发症总发生率低于参照组,总满意度高于参照组,差异有统计学意义(P<0.05);实验组下床活动时间、切口愈合时间、术后首次排便时间、住院时间均短于参照组,10 d内排便次数低于参照组,差异有统计学意义(P<0.05)。护理前两组FLACC评分比较,差异无统计学意义(P>0.05);两组护理后FLACC评分低于护理前,且护理后实验组FLACC评分低于参照组,差异有统计学意义(P<0.05)。结论在小儿尿道下裂修复术中给予整体护理联合ERAS措施,可促进患儿尽快康复,减轻其疼痛程度,降低并发症发生率,缩短住院时间,提升患儿家属满意度,值得临床借鉴。     

单孔加一孔联合ERAS在高位直肠及乙状结肠癌中的应用

目的 探讨单孔加一孔腹腔镜手术联合 ERAS 治疗高位直肠及乙状结肠癌的近期疗效。方法 回顾性分析 2017 年 11 月至2018 年 10 月在福建省肿瘤医院胃肠肿瘤外科进行加速康复外科干预的 92 例高位直肠及乙状结肠癌患者资料，根 据手术方式的不同，分为单孔加一孔手术联合快速康复外科组39 例及常规腹腔镜手术联合ERAS 组 53 例，对比两组围术 期情况。结果 两组患者基线资料无明显统计学差异（P ＞ 0.05），且在手术时间、出血量、上下切缘、清扫淋巴结数量及 并发症方面无明显统计学差异（P ＞ 0.05）。但单孔加一孔手术联合ERAS 组较常规手术联合ERAS 组，总切口长度更短 [（6.7±1.1）cm 比（8.5±1.3）cm，P=0.000]，术后首次下床时间更早 [（22.2±5.2）h 比（27.1±7.9）h，P=0.001]，首次排便 时间更早[（70.2±19.8）h比（83.1±20.4）h，P=0.005]，术后第一天C反应蛋白值更低[（43.5±28.6）mg/L比（57.2±33.2） mg/L，P=0.038]，术后住院时间更短 [（7.0±1.7）d 比（8.1±2.1）d，P=0.010]，且术后 2~4 天疼痛评分更低（P ＜ 0.05）。 结论 经验丰富的腔镜医师采用单孔加一孔手术治疗高位直肠及乙状结肠癌并联合 ERAS 干预是安全可行的，且单孔加一孔 手术可减低操作难度，具有疼痛轻、术后恢复快等优势，值得临床推广。     

The ONE‐MIND Study: Rationale and protocol for assessing the effects of ONlinE MINDfulness‐based cancer recovery for the prevention of fatigue and other common side effects during chemotherapy

Cancer patients often experience poor quality of life (QoL) during chemotherapy (CT) treatments due to side effects including fatigue, insomnia, pain and nausea/vomiting. Mindfulness‐based cancer recovery (MBCR) is an evidence‐based intervention for treating such symptoms, but has not been investigated as an adjunctive treatment during CT. This study aims to determine the efficacy of an online group MBCR programme delivered during CT in 12 real‐time interactive weekly sessions for managing fatigue (primary outcome). Secondary outcomes include sleep disturbance, pain, nausea/vomiting, mood, stress and QoL. Exploratory outcomes include cognitive function, white blood cell counts and return to work. The study is a two‐armed randomised controlled waitlist trial with 2:1 allocation to treatment (online group MBCR during CT) or control (waitlist usual care; online MBCR following CT completion) with a target sample size of N = 178. Participants are breast or colorectal cancer patients undergoing common CT regimens in Calgary, Canada. Online assessments using validated self‐reported instruments will take place at baseline, post‐MBCR, post‐CT and 12 months’ post‐baseline. If online MBCR delivered during CT significantly reduces fatigue in cancer patients’ post‐CT and also impacts secondary symptoms, this would provide evidence for including mindfulness training as an adjunctive symptom management therapy during CT.     

我国日间手术开展现状与前景展望

日间手术在国外已有上百年的发展历史，现已成为欧美国家重要手术模式。我国于20世纪初开始开展日间手术，但目前尚未普及，发展不平衡问题比较突出，存在认识不清、开展不规范、与医保支付对接不畅等问题。日间手术是一种使国家、医院和病人三方均受益的新型手术模式。近年来，国家相关管理部门积极引导，开展日间手术的医院明显增多，可以预见，我国日间手术即将进入快速发展的新阶段。因此，有条件的医院可以从简单、易操作的病种开始，落实临床路径，积累经验，再逐步稳妥展开。在保证质量的前提下，不断拓展日间手术范围，提高三、四级手术比例。同时，积极与医保支付政策对接，采取灵活的方式，获得医保的支持，更好地促进我国日间手术的快速发展。     

基于VAS评价右美托咪定在宫颈癌根治术后镇痛及术后快速康复中的临床效果

目的:研究右美托咪定在宫颈癌根治术后镇痛及术后快速康复中的临床应用效果。方法:将2015年7月至2018年7月在本院行宫颈癌根治术的86例患者随机分为对照组和观察组各43例。对照组术后镇痛采用舒芬太尼和格拉司琼，观察组术后镇痛加用右美托咪定。采用视觉模拟评分法（VAS）评价患者术后1 h、6 h、12 h、24 h、48 h疼痛情况，采用Ramesay评分法评价患者不同时间点镇静状况，记录并比较两组患者不同时间点收缩压、舒张压、心率及呼吸频率变化，比较两组患者不良反应发生情况。结果:观察组患者术后6 h、12 h、24 h、48 h VAS评分均明显低于对照组（P＜0.05），Ramesay评分均明显高于对照组（P＜0.05）；观察组和对照组患者术后不同时间点呼吸频率比较，差异无统计学意义，但术后6 h、12 h、24 h观察组患者收缩压、心率均明显低于对照组（P＜0.05），术后1 h、6 h观察组患者舒张压明显低于对照组（P＜0.05）；观察组患者恶心呕吐、高血压发生率较对照组明显减低。结论:右美托咪定用于宫颈癌根治术后镇痛，可以提高镇痛镇静效果，稳定患者血流动力学，有助于术后快速康复。