Conditional estimation of sensitivity and specificity from a phase 2 biomarker study allowing early termination for futility

Development of a disease screening biomarker involves several phases. In phase 2 its sensitivity and specificity is compared with established thresholds for minimally acceptable performance. Since we anticipate that most candidate markers will not prove to be useful and availability of specimens and funding is limited, early termination of a study is appropriate, if accumulating data indicate that the marker is inadequate. Yet, for markers that complete phase 2, we seek estimates of sensitivity and specificity to proceed with the design of subsequent phase 3 studies. We suggest early stopping criteria and estimation procedures that adjust for bias caused by the early termination option. An important aspect of our approach is to focus on properties of estimates conditional on reaching full study enrollment. We propose the conditional‐UMVUE and contrast it with other estimates, including naïve estimators, the well‐studied unconditional‐UMVUE and the mean and median Whitehead‐adjusted estimators. The conditional‐UMVUE appears to be a very good choice. Copyright © 2008 John Wiley & Sons, Ltd.     

Effects of self-management training in Type 2 diabetes: a randomized, prospective trial.

AIMS: The efficacy of three education programmes for Type 2 diabetic patients was tested in a randomized trial. A didactic-oriented training programme (treatment A) was compared with a self-management-oriented programme delivered in group sessions (treatment B). The latter programme was compared with a more individualized approach (treatment C). METHODS: One hundred and eighty-one Type 2 diabetic patients (age 55.6 +/- 6.3 years, diabetes duration 6.6 +/- 6.2 years, HbA(1c) 7.8 +/- 1.6%, female 49.7%) took part. Efficacy was assessed 3 months (t1) after baseline (t0) and at a follow-up 15 months (t2) after baseline. RESULTS: The fall in HbA(1c) in treatment B at t1 was sustained at t2 (t0 8.1 +/- 1.8%, t1 7.3 +/- 1.7%, t2 7.4 +/- 1.9%). In treatment A, HbA(1c) was unchanged throughout (t0 7.6 +/- 1.5%, t1 7.5 +/- 1.3%, t2 7.7 +/- 1.7%; treatment A vs. treatment B; P < 0.05). With the more individualized approach of treatment C, there was a fall in HbA(1c) at t1, but this was not sustained at t2 (t0 7.8 +/- 1.6%, t1 7.1 +/- 1.3%, t2 7.6 +/- 1.6%; treatment B vs. treatment C; P = 0.73). There were also significant benefits in treatment B subjects compared with treatment A in further medical (body mass index and fasting blood glucose), psychological (control, irritability and hunger dependency of eating behaviour, and trait anxiety) and behavioural (exercise) variables. There were no significant benefits of the more individualized treatment C compared with group treatment B. No significant differences were found regarding triglyceride levels, high-density lipoprotein, diabetes-related knowledge, negative well-being, urine or blood glucose levels or foot care. CONCLUSION: Self-management training had a significantly higher medium-term efficacy than didactic diabetes education. The group sessions were more effective than a more individualized approach.     

县级医院医疗仪器管理对策

医疗仪器在疾病诊断和医疗中的作用越来越大,完善的管理不仅可提高仪器的使用寿命和安全性,关系到医院的经济效益和社会效益,更关系到患者的利益.文章结合实际,提出县级医院医疗仪器管理对策.     

蚌埠医学院在校学生心理卫生调查

目的　了解蚌埠医学院在校学生心理状况 ,为素质教育提供服务。方法　采用症状自评量表 (SCL- 90 )对该校 1～ 4年级学生进行调查分析。结果　该校在校生有 5个因子得分高于全国大学生常模 ,高年级学生得分高于低年级 ,男女生在人际、抑郁、敌对、偏执等方面差异有显著性。结论　应针对大学生的心理特点 ,在大学院校进行心理健康教育。     

中国急性心肌梗塞的疾病经济负担

主要通过对急性心肌梗塞疾病经济负担的研究，总体描述进行二线预防的重要性。资料主要来源于中文文献检索、政府统计报表。主要利用直接医疗费用来计算疾病经济负担，而未考虑直接非医疗费用和间接费用。中日急性心肌梗塞的发病率约为45／10万。55／10万。城市高于农村，男性高于女性。在2000年，急性心肌梗塞的死亡率在城市为32．39／10万，农村为17．99／10万，其死亡率随年龄增长而相应增长。与发病率一样，城市高于农村，男性高于女性。25岁以上人群因急性心肌梗塞而损失的DALY在2000年为3．57DALYs／千人口。怎性心肌梗塞的直接医疗费用在国家卫生部部属医院为28257元／例，省级医院为8663元／例，县级医院为5447无／例。测算2000年急性心肌梗塞的疾病经济负担为13亿元。19亿元。但由于只有10．6％的急性心肌梗塞病人得到临床床治疗，因此，本测算结果可能低估了在中国实际发生的疾病经济负担。     

聚苯醚热固性改性及其性能研究

通过溴化聚苯醚和格利雅试剂反应，将不饱和基团烯丙基引入聚苯醚中实现其热固性改性，由^1H-NMR和FTIR进行结构表征。确定了烯丙化聚苯醚的固化工艺，并对其固化产物性能进行测试。结果表明：按合成新工艺制备的热固性聚苯醚，其固化产物具有优异的介电性能(低介电常数、低介电损耗因子)，良好的耐溶剂性能和低吸湿性。     

如何加强局部解剖学教学中的专业英语学习

医学专业英语教学是大部分医学院校教育的薄弱环节 ,作者认为应该在每门专业课中加强专业英语的教学。本文从局部解剖学教学的角度 ,提出一些解决措施 ,包括提高学生对专业英语的认识和学习动力、结合公共英语、构词法的教学、加强预习复习、启发式教学等 ,来提高局部解剖学专业英语的教学质量。     

Medical management of chronic pancreatitis

慢性胰腺炎的临床表现包括疼痛、脂肪泻和糖尿病。在西方国家，慢性胰腺炎最常见的病因是酗酒。70％以上的病人在就诊时有疼痛的临床表现，而且，这些患者中又有75％以上会在几年之后出现疼痛减轻或完全消失。对于所有的慢性胰腺炎的病人来说，均应排除非胰源性疼痛和胆道梗阻、胰腺假性囊肿等胰腺局部并发症。应建议所有慢性胰腺炎病人戒烟、戒酒。阿片类镇痛剂仅应用于治疗疼痛严重的病人。尽管有报道认为胰酶替代治疗有助于止痛，但是，对于已经确诊的慢性胰腺炎病人来说，该疗法无效。激素类药物进行腹腔神经丛阻滞术可能有助于病人度过剧烈疼痛期。顽固性疼痛是进行胰液引流或胰腺切除的适应证。建议应用适量胰酶替代联合(或不联合)制酸剂治疗营养不良。慢性胰腺炎导致的糖尿病与原发性糖尿病的治疗原则相似。