The tension-free vaginal tape operation: Is the inexperienced surgeon a risk factor? Learning curve and Swedish quality reference.
- 作者列表："Nüssler EK","Löfgren M","Lindkvist H","Idahl A
INTRODUCTION:To reduce the risk of avoidable damage to the patient when training surgeons, one must predefine what standards to achieve, as well as supervise and monitor trainees' performance. The aim of this study is to establish a quality reference, to devise comprehensive tension-free vaginal tape (TVT) learning curves and to compare trainees' results to our quality reference. MATERIAL AND METHODS:Using the Swedish National Quality Register for Gynecologic Surgery, we devised TVT learning curves for all Swedish TVT trainees from 2009 to 2017, covering their first 50 operations. These outcomes were compared with the results of Sweden's most experienced TVT surgeons for 14 quality variables. RESULTS:In all, 163 trainees performed 2804 operations and 40 experienced surgeons performed 3482 operations. For our primary outcomes - perioperative bladder perforations and urinary continence after 1 year - as well as re-admission, re-operation and days to all daily living activities, there was no statistically significant difference between trainees and experienced surgeons at any time. For the first 10 trainee operations only, there were small differences in favor of the experienced surgeons: patient-reported minor complications after discharge (14% vs 18.4%, P = .002), 1-year patient-reported improvement (95.9% vs 91.8%, P < .000), and patient satisfaction (90.9% vs 86.2%, P = .002). For both trainee operations 1-10 and 11-50, compared with experienced surgeons, operation time (33.8 vs 22.2 min, P < .000; 28.3 vs 22.2 min, P < .000) and hospital stay time (0.16 vs 0.06 days, P < .001; 0.1 vs 0.06 days, P < .001) were longer, perioperative blood loss was higher (27.7 vs 24.4 mL, P = .001; 26.5 vs 24.4 mL, P = .004), and patient-reported catheterization within 8 weeks was higher (3.9% vs 1.8%, P < .000; 2.5% vs 1.8%, P = .001). One-year voiding difficulties for trainee patients (operations 1-10:14.2%, P = .260; operations 11-50:14.5%, P = .126) were comparable to the experienced surgeons (12.4%). CONCLUSIONS:There is a learning curve for several secondary outcomes but the small effect size makes it improbable that the difference has clinical significance. Our national Swedish results show that it is possible to train new TVT surgeons without exposing patients to noteworthy extra risk and achieve results which are equivalent to the most experienced Swedish surgeons.
引言: 在培训外科医生时，为了降低对患者造成可避免的损害的风险，必须预先定义要达到的标准，并监督和监控学员的表现。本研究的目的是建立质量参考，设计全面的无张力阴道吊带 (TVT) 学习曲线，并将学员的结果与我们的质量参考进行比较。 材料和方法: 使用瑞典国家妇科手术质量注册，我们为2009年至2017年的所有瑞典TVT学员设计了TVT学习曲线，涵盖了他们的前50次手术。将这些结果与瑞典最有经验的TVT外科医生的14个质量变量的结果进行比较。 结果: 共有163名学员完成了2804例手术，40名经验丰富的外科医生完成了3482例手术。对于我们的主要结局-1年后的围手术期膀胱穿孔和控尿-以及再次入院，再次手术和所有日常生活活动的天数，受训者和有经验的外科医生在任何时候都没有统计学显著差异。仅对于前10名见习手术，经验丰富的外科医生有微小差异: 患者报告出院后出现轻微并发症 (14% vs 18.4%，P = .002)，1年患者报告改善 (95.9% vs 91.8%，P <.000)，和患者满意度 (90.9% vs 86.2%，P = .002)。对于见习手术1-10和11-50，与有经验的外科医生相比，手术时间 (33.8 vs 22.2 min，P <。000; 28.3 vs 22.2 min，P <.000) 和住院时间 (0.16 vs 0.06天，P <.001; 0.1 vs 0.06天，P <.001) 较长，围手术期失血量较高 (27.7 vs 24.4 mL，P = .001; 26.5 vs 24.4 mL，P = .004)，患者报告的8周内导管插入术较高 (3.9% vs 1.8%，P <.000; 2.5% vs 1.8%，P = .001)。实习患者的一年排尿困难 (手术1-10:14.2%，P = .260; 手术11-50:14.5%，P = .126) 与有经验的外科医生 (12.4%) 相当。 结论: 有几个次要结果的学习曲线，但小的效应大小使得差异不太可能具有临床意义。我们的瑞典国家研究结果表明，有可能培训新的TVT外科医生，而不会让患者暴露在值得注意的额外风险中，并取得相当于最有经验的瑞典外科医生的结果。
METHODS::The ATP binding-cassette superfamily corresponds the mostly transmembrane transporters family found in humans. These proteins actively transport endogenous and exogenous substrates through biological membranes in body tissues, so they have an important role in the regulation of many physiological functions necessary for human homeostasis, as well as in response regulation to several pharmacological substrates. The development of multidrug resistance has become one of the main troubles in conventional chemotherapy in different illnesses including cancer, being the increased efflux of antineoplastic drugs the main reason for this multidrug resistance, with a key role of the ABC superfamily. Likely, the interindividual variability in the pharmacological response among patients is well known, and may be due to intrinsically factors of the disease, genetic and environmental ones. Thus, the understanding of this variability, especially the genetic variability associated with the efficacy and toxicity of drugs, can provide a safer and more effective pharmacological treatment, so ABC genes are considered as important regulators due to their relationship with the reduction in pharmacological response. In this review, updated information about transporters belonging to this superfamily was collected, the possible role of these transporters in cancer, the role of genetic variability in their genes, as well as some therapeutic tools that have been tried to raise against main transporters associated with chemoresistance in cancer.
METHODS:BACKGROUND:Cholinergic neurotransmission regulates neuroinflammation in Parkinson disease (PD). RESEARCH DESIGN AND METHODS:The authors conducted a delayed-start study of donepezil for cognitive decline in non-demented PD patients. The study consisted of a 96-week randomized placebo-controlled double-blind phase 1, followed by a 24-week donepezil extension phase 2. The primary outcome measure was a change in the Mini-Mental State Examination (MMSE) at week 120. RESULTS:A total of 98 patients were randomly allocated to the early-start (donepezil-to-donepezil) and delayed-start (placebo-to-donepezil) groups. Mean (SD) of the baseline MMSE was 27.6 (2.0) and 28.0 (2.1), respectively. MMSE change at week 120 was better in the early-start group than in the delayed-start group, but the difference was not significant. The MMSE declined in apolipoprotein ε4 carriers, but not in non-carriers, and the factor interaction (intervention × ε4 genotype) was highly significant (P < 0.001). Analyzed with the interaction, the difference was significant (group difference 1.95 [0.33 to 3.57], P = 0.018). The MMSE decline slope in phase 1 was significantly better in the early-start group than in the delayed-start group (P = 0.048). CONCLUSIONS:Cognitive function deteriorated in ε4 carriers, but not in non-carriers, and early-start donepezil may postpone cognitive decline in the former.
METHODS::Since the discovery of dental pulp stem cells, a lot of teams have expressed an interest in dental pulp regeneration. Many approaches, experimental models and biological explorations have been developed, each including the use of stem cells and scaffolds with the final goal being clinical application in humans. In this review, the authors' objective was to compare the experimental models and strategies used for the development of biomaterials for tissue engineering of dental pulp with stem cells. Electronic queries were conducted on PubMed using the following terms: pulp regeneration, scaffold, stem cells, tissue engineering and biomaterial. The extracted data included the following information: the strategy envisaged, the type of stem cells, the experimental models, the exploration or analysis methods, the cytotoxicity or viability or proliferation cellular tests, the tests of scaffold antibacterial properties and take into account the vascularization of the regenerated dental pulp. From the 71 selected articles, 59% focused on the "cell-transplantation" strategy, 82% used in vitro experimentation, 58% in vivo animal models and only one described an in vivo in situ human clinical study. 87% used dental pulp stem cells. A majority of the studies reported histology (75%) and immunohistochemistry explorations (66%). 73% mentioned the use of cytotoxicity, proliferation or viability tests. 48% took vascularization into account but only 6% studied the antibacterial properties of the scaffolds. This article gives an overview of the methods used to regenerate dental pulp from stem cells and should help researchers create the best development strategies for research in this field.