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.     

Low percentage of patients passed the ‘Back in Action’ test battery 9 months after bone-patellar tendon-bone anterior cruciate ligament reconstruction

BackgroundAnterior cruciate ligament (ACL) reconstruction is recommended in patients who intend to return to high-level sports. However, there is only a 55–80% return to pre-injury level of sports after ACL reconstruction, with a re-injury rate up to 20%. The aim of this study was to determine the percentage of patients passing the Back in Action (BIA) test 9 months after primary bone-patellar-tendon-bone (BPTB) ACL reconstruction, and evaluate the association between passing the BIA test and patient reported outcome measurements (PROMs).MethodsPatients underwent the BIA test 9 months after BPTB ACL reconstruction. In total 103 patients were included. Passing the BIA test (PASSED-group) was defined as a normal or higher score at all sub-tests with limb symmetry index (LSI) ≥90% for the dominant leg and LSI >80% for the non-dominant leg. Patients who did not meet these criteria were defined as the FAILED-group. PROMs included the International Knee Documentation Committee, Knee injury Osteoarthritis Outcome Score and Anterior Cruciate Ligament-Return to Sport after Injury.ResultsEighteen patients (17.5%) passed the BIA test 9 months after BPTB ACL reconstruction. PROMs were not statistically significant different between the PASSED- and FAILED-group.ConclusionLow percentage of patients passed the BIA test 9 months after BPTB ACL reconstruction. Although current PROMs cut-off values were met, the BIA test results show persistent functional deficits. Therefore, the BIA test could be of additional value in the decision-making process regarding return to sport (RTS). This study highlights the need for additional rehabilitation as RTS in a condition of incomplete recovery may increase the risk of re-injury.Level of evidenceII.     

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。