静脉药物配制中心安全管理实践

静脉药物配制中心（PIVAS）是为保证病人的输液质量而对输液进行集中管理、集中配制的新形式。它打破了传统的在开放条件下进行药物配制的工作流程，使操作人员在局部百级洁净区严格按照无菌配制技术集中配制药物，可以防止细菌和微粒的污染，为病人提供无菌、安全、高效的药品，并可减少由于输液反应而引发的医疗纠纷；通过购买大包装的药品，可以降低药晶价格、减少药品浪费、降低医疗成本；临床护士用于药品配制的时间大大缩短，提高了护理质量。虽然PIVAS在医院工作中受到欢迎，但由于运行环节较多，且在我院启用的时间不长，还是一项不成熟的服务模式，我们也发现一些尚待提高和解决的问题。针对存在的安全隐患，制订了一系列防范措施，经过半年多的实践，在实施过程中运行良好。现总结如下。     

以人为本理念在全程护理服务中的实践

为了探索既符合中国国情又能满足病人需求的护理服务新模式，浙江省台州市中心医院自2002年开始试行全程护理服务。在实施护理中以病人为中心，从理念上、环境上、权益上、细节上为病人提供全面、全员、全程的人本服务；在管理实践中，提倡“尊、理、信、谐、通、创”六字理念，将管理视为服务，实行人本管理。通过3年的实践，整体护理质量、病人满意度、护士对工作满意度均有显著提高。     

胸锁钩钢板治疗锁骨近端骨折伴胸锁关节脱位

目的： 探讨新型胸锁钩钢板治疗锁骨近端骨折伴胸锁关节脱位的临床疗效。方法： 回顾性分析2011年6月至2019年1月采用新型胸锁钩钢板进行内固定治疗的13例锁骨近端骨折伴胸锁关节脱位患者的临床资料,其中男9例,女4例;年龄26~78（54.08±13.91）岁。记录患者的手术时间、出血量、住院时间、术后并发症等情况。术后根据X线和CT评估骨折复位以及愈合情况。术后12个月采用Constant-Murley评分和Rockwood胸锁关节评分评定患肢功能恢复情况。结果： 13例患者均获得随访,时间12~24（16.77±4.63）个月。切口均Ⅰ期愈合,愈合时间9~13（11.00±1.75） d,骨性愈合时间3~4（3.65±0.46）个月。手术时间50~76（54.08±13.91） min,术中出血量20~56（46.08±11.15） ml,住院时间6~14（8.31±2.32） d。术后未出现感染、内固定失败、神经损伤等并发症。术后12个月Constant-Murley评分为（87.83±11.26）分;Rockwood评分（13.70±1.85）分,其中优11例,良1例,可1例。结论： 采用新型胸锁钩钢板治疗锁骨近端骨折伴胸锁关节脱位,可以早期进行关节功能锻炼,患者功能恢复优良,是治疗锁骨近端骨折伴胸锁关节脱位的有效方法。     

基于一体化手术平台的LC联合术中ERCP治疗胆囊结石合并胆总管结石的效果研究

目的 探讨一体化手术平台中行腹腔镜胆囊切除术（LC）联合术中内镜逆行性胆胰管造影（ERCP）治疗胆囊结石合并胆总管结石的效果,并与序贯二步法ERCP+LC进行比较。方法 回顾性分析2019年12月至2020年12月由台州医院和恩泽医院肝胆胰外科完成治疗的82例胆囊结石合并胆总管结石患者临床资料,其中在一体化手术平台完成LC联合术中ERCP治疗的37例患者分为A组,完成序贯二步法ERCP+LC治疗的45例患者分为B组,比较两组手术时间、术中出血量、结石清除率、疼痛评分、排气时间、下床活动时间、术后并发症发生率、住院时间、住院费用等指标的差异。结果 两组术前基本资料比较无统计学差异,具有可比性（P>0.05）。两组在手术时间、术中出血量、结石清除率、术后疼痛评分、住院费用等方面无明显统计学差异（P>0.05）。A组术后排气时间[（16.0±4.5）h vs （19.9±6.0）h]、下床活动时间[（8.4±2.0）h vs （13.4±3.8）h]以及住院时间[（4.7±0.7）d vs （7.4±1.0）d]均明显短于B组（P<0.05）。两组患者在术后疼痛评分、住院费用方面无明显差异（P>0.05）。A组患者手术并发症总发生率[2.7%（1/37） vs 20.0%（9/45）]明显少于B组,差异有统计学意义（P<0.05）。结论 在一体化手术平台行LC联合术中ERCP治疗胆囊结石合并胆总管结石较序贯二步法ERCP+LC效果更好,能缩短住院时间,减少手术并发症,且不增加住院费用,是一种较好的治疗手段。     

Mental health improvements after elective spine surgery: a Canadian Spine Outcome Research Network (CSORN) study

BACKGROUND CONTEXTSpine patients have a higher rate of depression then the general population which may be caused in part by levels of pain and disability from their spinal disease.PURPOSEDetermination whether improvements in health-related quality of life (HRQOL) resulting from successful spine surgery leads to improvements in mental health.STUDY DESIGN/SETTINGThe Canadian Spine Outcome Research Network prospective surgical outcome registry.OUTCOME MEASURESChange between preoperative and postoperative SF12 Mental Component Score (MCS). Secondary outcomes include European Quality of Life (EuroQoL) Healthstate, SF-12 Physical Component Score (PCS), Oswestry Disability Index (ODI), Patient Health Questionaire-9 (PHQ9), and pain scales.METHODSThe Canadian Spine Outcome Research Network registry was queried for all patients receiving surgery for degenerative thoracolumbar spine disease. Exclusion criteria were trauma, tumor, infection, and previous spine surgery. SF12 Mental Component Scores (MCS) were compared between those with and without significant improvement in postoperative disability (ODI) and secondary measures. Multivariate analysis examined factors predictive of MCS improvement.RESULTSEighteen hospitals contributed 3222 eligible patients. Worse ODI, EuroQoL, PCS, back pain and leg pain correlated with worse MCS at all time points. Overall, patients had an improvement in MCS that occurred within 3 months of surgery and was still present 24 months after surgery. Patients exceeding Minimally Clinically Important Differences in ODI had the greatest improvements in MCS. Major depression prevalence decreased up to 48% following surgery, depending on spine diagnosis.CONCLUSIONSLarge scale, real world, registry data suggests that successful surgery for degenerative lumbar disease is associated with reduction in the prevalence of major depression regardless of the specific underlaying diagnosis. Worse baseline MCS was associated with worse baseline HRQOL and improved postoperatively with coincident improvement in disability, emphasizing that mental wellness is not a static state but may improve with well-planned spine surgery.     

Validity and reliability of the Thai version of the Spine Oncology Study Group Outcomes Questionnaire version 2.0 to assess Quality of Life in Patients with Spinal Metastasis

Background ContextThe Spine Oncology Study Group Outcomes Questionnaire version 2.0 (SOSGOQ2.0) is a spinal metastasis (SM)-specific quality of life (QoL) questionnaire that was previously reported to have good reliability and validity. There is currently no Thai version of the SOSGOQ 2.0. (TH-SOSGOQ2.0).PurposeTo assess the psychometric properties of the TH-SOSGOQ 2.0.Study Design/SettingCross-sectional study. Faculty of Medicine Siriraj Hospital, Mahidol University.Patient SamplePatients who were confirmed diagnosis of metastatic spinal disease, age 18 to 75 years, and having already undergone surgery and/or radiotherapy for the treatment of spinal metastasis.Outcome MeasuresValidity and reliability of the TH-SOSGOQ 2.0 to assess QoL in Patients with SM.MethodsUsing the forward-backward translation technique, the SOSGOQ2.0 was translated into Thai language to create the TH-SOSGOQ2.0. SM patients were prospectively enrolled and evaluated for patient QoL using both the TH-SOSGOQ2.0 and the EQ-5D-5L (Thai version) at baseline and 3 months after treatment. Construct validity was assessed using multi-trait scaling analysis, confirmatory factor analysis, and correlation with EQ-5D-5L. Test-retest reliability was assessed in a subgroup of patients who took the TH-SOSGOQ2.0 two times one week apart.ResultsSixty-eight patients (mean age: 57 years; 30 males, 38 females) were included. The Cronbach's alpha values for the total score, physical function, neurological function, pain, mental health, social function, and post-therapy domains were 0.87, 0.89, 0.91, 0.84, 0.82, 0.75, and 0.85, respectively. Good reliability was demonstrated (interclass correlation coefficient range: 0.70-0.84), except for the social function domain (0.60). Regarding concurrent validity, the TH-SOSGOQ2.0 domains demonstrated moderate to good correlation with the corresponding EQ-5D-5L 9 (Thai version) domains (range: -0.32 to -0.78). Physical function was the most well-correlated domain with the EQ-5D-5L (Thai version) (-0.77).ConclusionsTH-SOSGOQ2.0 demonstrated good reliability and validity for assessing QoL in Thai SM patients.     

Modified-frailty index does not independently predict complications,hospital length of stay or 30-day readmission rates following posterior lumbar decompression and fusion for spondylolisthesis

BACKGROUND CONTEXTFrailty has been associated with inferior surgical outcomes in various fields of spinal surgery. With increasing healthcare costs, hospital length of stay (LOS) and unplanned readmissions have emerged as clinical proxies reflecting overall value of care. However, there is a paucity of data assessing the impact that baseline frailty has on quality of care in patients with spondylolisthesis.PURPOSEThe aim of this study was to investigate the impact that frailty has on LOS, complication rate, and unplanned readmission after posterior lumbar spinal fusion for spondylolisthesis.STUDY DESIGNA retrospective cohort study was performed using the National Surgical Quality Improvement Program (NSQIP) database from 2010 through 2016.PATIENT SAMPLEAll adult (≥18 years old) patients who underwent lumbar spinal decompression and fusion for spondylolisthesis were identified using ICD-9-CM diagnosis and procedural coding systems. We calculated the modified frailty index (mFI) for each patient using 5 dichotomous comorbidities - diabetes mellitus, congestive heart failure, hypertension requiring medication, chronic obstructive pulmonary disease, and dependent functional status. Each comorbidity is assigned 1 point and the points are summed to give a score between 0 and 5. As in previous literature, we defined a score of 0 as “not frail”, 1 as “mild” frailty, and 2 or greater as “moderate to severe” frailty.OUTCOME MEASURESPatient demographics, comorbidities, complications, LOS, readmission, and reoperation were assessed.METHODSA multivariate logistic regression analysis was used to identify independent predictors of adverse events (AEs), extended LOS, complications, and unplanned readmission.RESULTSThere were a total of 5,296 patients identified, of which 2,030 (38.3%) were mFI=0, 2,319 (43.8%) patients mFI=1, and 947 (17.9%) were mFI ≥2. The mFI≥2 cohort was older (p≤.001) and had a greater average BMI (p≤.001). The mFI≥2 cohort had a slightly longer hospital stay (3.7 ± 2.3 days vs. mFI=1: 3.5 ± 2.8 days and mFI=0: 3.2 ± 2.1 days, p≤.001). Both surgical AEs and medical AEs were significantly greater in the mFI≥2 cohort than the other cohorts, (2.6% vs. mFI=1: 1.8% and mFI=0: 1.2%, p=.022) and (6.3% vs. mFI=1: 4.8% and mFI=0: 2.6%, p≤.001), respectively. While there was no significant difference in reoperation rates, the mFI≥2 cohort had greater unplanned 30-day readmission rates (8;4% vs. mFI=5.6: 4.8% and mFI=0: 3.4%, p≤.001). However, on multivariate regression analysis, mFI≥2 was not a significant independent predictor of LOS (p=.285), complications (p=.667), or 30-day unplanned readmission (p=.378).CONCLUSIONSOur study indicates that frailty, as measured by the mFI, does not significantly predict LOS, 30-day adverse events, or 30-day unplanned readmission in patients undergoing lumbar spinal decompression and fusion for spondylolisthesis. Further work is needed to better define variable inputs that make up frailty to optimize surgical outcome prediction tools that impact the value of care.     

Comparison of 3D-printed titanium-alloy,standard titanium-alloy,and PEEK interbody spacers in an ovine model

BACKGROUND CONTEXTOsseointegration is a pivotal process in achieving a rigid fusion and ultimately a successful clinical outcome following interbody fusion surgery. Advancements in 3D printing technology permit commonly used titanium interbody spacers to be designed with unique architectures, such as a highly interconnected and specific porous structure that mimics the architecture of trabecular bone. Interbody implants with a microscale surface roughness and biomimetic porosity may improve bony ongrowth and ingrowth compared to traditional materials.PURPOSEThe purpose of this study was to compare the osseointegration of lumbar interbody fusion devices composed of surgical-grade polyetheretherketone (PEEK), titanium-alloy (TAV), and 3D-printed porous, biomimetic TAV (3DP) using an in vivo ovine model.STUDY DESIGNIn Vivo Preclinical Animal StudyMETHODSEighteen sheep underwent two-level lateral lumbar interbody fusion randomized with either 3DP, PEEK, or TAV interbody spacers (n=6 levels for each spacer per time point). Postoperative time points were 6 and 12 weeks. Microcomputed tomography and histomorphometry were used to quantify bone volume (BV) within the spacers (ingrowth) and the surface bone apposition ratio (BAR) (ongrowth), respectively.RESULTSThe 3DP-treatment group demonstrated significantly higher BV than the PEEK and TAV groups at 6 weeks (77.3±44.1 mm³, 116.9±43.0 mm³, and 108.7±15.2 mm³, respectively) (p<.05). At 12 weeks, there were no BV differences between groups (p>.05). BV increased in all groups from the 6- to 12-week time points (p<.05). At both time points, the 3DP-treated group (6w: 23.6±10.9%; 12w: 36.5±10.9%) had significantly greater BAR than the PEEK (6w: 8.6±2.1%; 12w: 14.0±5.0%) and TAV (6w: 6.0±5.7%; 12w: 4.1±3.3%) groups (p<.05).CONCLUSIONS3DP interbody spacers facilitated greater total bony ingrowth at 6 weeks, and greater bony ongrowth postoperatively at both 6 and 12 weeks, in comparison to solid PEEK and TAV implants.CLINICAL SIGNIFICANCEBased on these findings, the 3DP spacers may be a reasonable alternative to traditional PEEK and TAV spacers in various clinical applications of interbody fusion.     

Outcomes of the use of cement-augmented cannulated pedicle screws in lumbar spinal fusion

BACKGROUND CONTEXTThere are few studies of the radio-clinical outcomes of cement-augmented cannulated pedicle screw (CPS) fixation in osteoporotic patients.PURPOSETo compare the radiological and clinical outcomes between groups receiving cement-augmented CPS and solid pedicle screws (SPS) in lumbar fusion surgery.STUDY DESIGN/SETTINGRetrospective comparative studyPATIENT SAMPLEA total of 187 patients who underwent lumbar fusion surgery for degenerative spinal stenosis or spondylolisthesis from 2014 to 2019.OUTCOME MEASURESRadiological evaluation included screw failure, cage failure, rod breakage, and fusion grade at postoperative 6 months and 1 year. Pre- and postoperative visual analog scales for back pain (VAS-BP), leg pain (VAS-LP), Korean Oswestry disability index (K-ODI), and postoperative complications were also compared.METHODSOutcomes of patients with high risk factors for implant failure [old age, osteoporosis, autoimmune disease or chronic kidney disease (CKD)] who underwent open transforaminal lumbar interbody fusion with cement-augmented CPS fixation (Group C, n=55) or SPS fixation (Group S, n=132) were compared.RESULTS324 pedicle screws in Group C and 775 pedicle screws in Group S were analyzed. Group C had a significantly higher average age and lower T-score, and included more patients with autoimmune disease and CKD than group S (all p<.05). Clear zones, screw migration and loss of correction were significantly less frequent in Group C (all p<.05). Thirteen screw breakages were observed; they were only in Group C (4.0%) and all were in the proximal of the two holes. Interbody and posterolateral fusion rates were not significantly different. At last follow-up, all clinical parameters including VAS-BP, VAS-LP, and K-ODI scores had improved significantly in both groups. Postoperative complications were not significantly different in the two groups.CONCLUSIONIn lumbar fusion surgery, using cement-augmented CPS in high-risk groups for implant failure could be a useful technical option for reducing acute radiological complications and obtaining clinical results comparable to those obtained using SPS in patients with low risk of implant failure.LEVEL OF EVIDENCELevel 4