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How distressing is it to participate in medical research? A calibration study using an everyday events questionnaire. 参与医学研究有多痛苦?一项使用日常事件问卷的校准研究。
Pub Date : 2013-09-13 eCollection Date: 2013-01-01 DOI: 10.1177/2042533313493271
Keith J Petrie, Kate Faasse, Tracey Anne Notman, Ronan O'Carroll

Objectives: To investigate how distressing participating in medical research is perceived to be, compared to everyday events.

Design: Anonymous questionnaire.

Setting: Scotland and New Zealand.

Participants: One hundred members of the Scottish general public, 94 University of Auckland students, 22 New Zealand Ministry of Health ethics committee members.

Main outcome measures: Distress ratings made on a 0-10 scale for everyday events and common medical research procedures.

Results: Both general population and student samples generally rated the distress caused by participating in various medical research procedures as low or very low. Most research procedures were rated less than the distress caused by not being able to find a car park at a supermarket. In contrast, the ethics committee members rated the distress caused by most of the medical research procedures at a significantly higher level than the ratings of the student and general population samples. Ethics committee members overestimated the distress caused by interview or questionnaire assessments (M = 203.31%, SE = 11.42, 95% CI [179.79, 226.83]) more than medical testing for research (M = 158.06%, SE = 12.33, 95% CI [132.66, 183.46], p = 0.04) and everyday events (M = 133.10%, SE = 7.80, 95% CI [117.03, 149.16], p < 0.001).

Conclusions: Common medical research procedures are not rated as particularly distressing by the general public, and ethics committees may be adopting an over-protective role when evaluating research applications that involve the use of questionnaire or survey methodology.

目的:调查与日常事件相比,参与医学研究的痛苦程度。设计:匿名问卷。背景:苏格兰和新西兰。参与者:100名苏格兰公众,94名奥克兰大学学生,22名新西兰卫生部伦理委员会成员。主要结果测量:对日常事件和常见医学研究程序进行0-10级的痛苦评分。结果:一般人群和学生样本普遍认为参与各种医学研究程序所造成的痛苦为低或非常低。大多数研究过程的评分都低于因在超市找不到停车位而造成的痛苦。相比之下,伦理委员会成员对大多数医学研究程序造成的痛苦的评分明显高于学生和一般人群样本的评分。伦理委员会成员对访谈或问卷评估造成的痛苦的高估(M = 203.31%, SE = 11.42, 95% CI[179.79, 226.83])高于对研究(M = 158.06%, SE = 12.33, 95% CI [132.66, 183.46], p = 0.04)和日常事件(M = 133.10%, SE = 7.80, 95% CI [117.03, 149.16], p。一般公众并不认为普通医学研究程序特别令人痛苦,伦理委员会在评估涉及使用问卷调查或调查方法的研究申请时可能采取了过度保护的作用。
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引用次数: 10
An important diagnosis to consider in recurrent meningitis. 复发性脑膜炎的重要诊断。
Pub Date : 2013-07-30 eCollection Date: 2013-01-01 DOI: 10.1177/2042533313486640
Nisha Verma, Lloyd E Savy, Valerie J Lund, Ian Cropley, Ronnie Chee, Suranjith L Seneviratne
Meningitis, a potentially life threatening illness, requires prompt recognition and treatment. Recurrent meningitis necessitates detailed investigations to identify the underlying cause. We describe two adult patients with recurrent meningitis due to an underlying skull base abnormality.
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引用次数: 6
Avastin and Lucentis: what do patients know? A prospective questionnaire survey. 阿瓦斯汀和Lucentis:患者知道什么?前瞻性问卷调查。
Pub Date : 2013-07-30 eCollection Date: 2013-01-01 DOI: 10.1177/2042533313484146
Avinash Manna, Oluwatoyin Oyede, Brigid Ning, Yit Yang, Niro Narendran

Objectives: To assess patients' knowledge of their drug therapy for neovascular macular degeneration and to identify which aspects of the drug they considered most important if given the option of switching to an alternative drug.

Design: Prospective questionnaire survey.

Setting: Wolverhampton, England.

Participants: A total of 126 patients attending our hospital service for intravitreal ranibizumab therapy for neovascular macular degeneration.

Main outcome measures: Using a questionnaire, patients were asked questions pertaining to aspects of drug therapy in neovascular macular degeneration. Fields covered included drug names, knowledge of alternative drugs, cost of drugs and their views on switching to another drug.

Results: Eighty (63.5%) had heard of Lucentis (ranibizumab) and 31 (24.6%) were aware of Avastin (bevacizumab). Of the latter 31 patients, 20 did not have a preference between Avastin and Lucentis. These patients felt that the factors they would consider important for them to consider switching were effectiveness (10, 50%), specialist recommendation (8, 40%), safety (2, 10%) and cost (0).

Conclusions: Introducing a cheaper, off-label alternative in the therapy of macular degeneration in the presence of a licensed option has been extensively debated. Many patients have no knowledge of this controversial issue but it is likely that efficacy and recommendation by clinicians are more important than cost to patients who may consider switching to the off-label Avastin.

目的:评估患者对新血管性黄斑变性药物治疗的认识,并确定如果选择改用替代药物,他们认为药物的哪些方面最重要。设计:前瞻性问卷调查。背景:英国伍尔弗汉普顿。参与者:共有126例患者在我院接受玻璃体内雷尼单抗治疗新血管性黄斑变性。主要结果测量:通过问卷调查,向患者询问有关新血管性黄斑变性药物治疗方面的问题。涉及的领域包括药物名称、替代药物的知识、药物的成本以及他们对改用另一种药物的看法。结果:80人(63.5%)听说过Lucentis(雷尼单抗),31人(24.6%)知道Avastin(贝伐单抗)。在后31名患者中,20名患者在阿瓦斯汀和Lucentis之间没有偏好。这些患者认为他们考虑转换的重要因素是有效性(10.50%),专家推荐(8.40%),安全性(2,10%)和成本(0%)。结论:在已有许可的黄斑变性治疗方案中引入更便宜的非说明书替代方案一直存在广泛的争议。许多患者不知道这一有争议的问题,但对于可能考虑改用非标签阿瓦斯汀的患者来说,临床医生的疗效和建议可能比成本更重要。
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引用次数: 0
Sustained bilateral middle ear effusions post orthognathic surgery successfully treated with grommet insertion. 正颌手术后持续的双侧中耳积液经植皮成功治疗。
Pub Date : 2013-07-30 eCollection Date: 2013-01-01 DOI: 10.1177/2042533313489822
Ashwin Algudkar, Bernard Lim, Kathleen Fan, Robert Bentley
We present the case of a patient who developed persistent bilateral middle ear effusions post Le Fort I maxillary osteotomy.
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引用次数: 3
Prevalence of cholecystitis in gallbladder histology following clinical pancreatitis: cohort study. 临床胰腺炎后胆囊组织学胆囊炎的患病率:队列研究。
Pub Date : 2013-07-30 eCollection Date: 2013-01-01 DOI: 10.1177/2042533313490294
Amy Hung, Savitha Honakeri, Andrew Giles, Adrian Steger
We looked into gallbladder histology over one year to see whether those who have had pancreatitis have any difference in their reports compared to those who have had cholecystitis.
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引用次数: 3
Fatal pulmonary embolism update: 10 years of autopsy experience at an academic medical center. 致命的肺栓塞更新:10年的尸检经验,在一个学术医疗中心。
Pub Date : 2013-07-30 eCollection Date: 2013-01-01 DOI: 10.1177/2042533313489824
Patrick H Sweet, Theodore Armstrong, John Chen, Eliezer Masliah, Peter Witucki

Objective: To investigate the rate of death caused by pulmonary embolism (PE) and the antemortem performance in diagnosis and treatment of PE.

Design: A systematic search of cases involving fatal PE via PowerPath® (Sunquest) followed by chart review.

Setting: An academic medical centre located in San Diego, United States of America.

Participants: Postmortem cases with pathological findings of PE.

Main outcome measures: After data collection and collation, the data were subject to analysis.

Results: From 2002 to 2012, PE was identified as the mechanism of death in 108 of 982 cases (11%, 95% CI 9.01-12.99%) at an institution with an average autopsy rate of 30% ± 0.07%. Excluding cases where care was withheld (by advance directive) or unavailable, 29 of 108 were eligible for antemortem treatment for PE. In 31% (nine of 29) of these cases the diagnosis of PE was considered antemortem. Only three of 29 were given thrombolytics despite only one case being contraindicated.

Conclusion: The rate of PE-related death is consistent with most other autopsy series and major epidemiologic studies despite advances in system wide deep venous thrombosis prophylaxis. The results validate previous studies that this diagnosis is often missed but probably improving compared to historical standards. Even when the diagnosis is considered, however, thrombolytics are not routinely given, even without contraindications. The cause of this failure to treat may require further study with comparison to patients that were treated to determine the utilization of this treatment. It also underscores the continued difficulty in the diagnosis of this disease.

目的:探讨肺栓塞(PE)的死亡率及其在肺栓塞诊断和治疗中的作用。设计:通过PowerPath®(Sunquest)系统搜索涉及致命性PE的病例,然后进行图表审查。环境:位于美利坚合众国圣地亚哥的一个学术医疗中心。研究对象:有PE病理表现的死后病例。主要观察指标:数据收集整理后,对数据进行分析。结果:2002 - 2012年,该机构982例患者中有108例(11%,95% CI 9.01-12.99%)被确定为PE死亡机制,平均尸检率为30%±0.07%。排除那些护理被拒绝(通过预先指示)或无法获得的病例,108人中有29人有资格接受临终前治疗。在这些病例中,31%(29例中的9例)的PE诊断被认为是死前的。29例患者中只有3例接受了溶栓治疗,尽管只有1例有禁忌症。结论:尽管在全系统深静脉血栓预防方面取得了进展,但pe相关死亡率与大多数其他尸检系列和主要流行病学研究一致。结果证实了先前的研究,即这种诊断经常被遗漏,但与历史标准相比可能有所改善。然而,即使考虑到诊断,即使没有禁忌症,溶栓也不是常规给予的。这种治疗失败的原因可能需要进一步研究,并与接受治疗的患者进行比较,以确定这种治疗的使用。它还强调了诊断这种疾病的持续困难。
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引用次数: 48
Antibacterial effect of incorporating silver ions in electrochemically deposited hydroxyapatite coating: An experimental study. 电化学沉积羟基磷灰石涂层中加入银离子抑菌效果的实验研究。
Pub Date : 2013-07-30 eCollection Date: 2013-01-01 DOI: 10.1177/2042533313481212
Yaser Ghani, Melanie J Coathup, Karin A Hing, Gordon W Blunn
XRD and EDX analyses confirmed the presence of Ag in all coatings deposited using electrochemical method and silver. The mean thickness coating was noted to be highest in EHA/AG group (102.20 4.20 um) followed by PHA (76.40 2.20 um). Mean coating thicknesses in other groups were: PHA/AgNO3 (76.20 1.29 um); EHA (32.98 2.50 um); EHA/ Ag/2-layers (30.70 2.40 um); EHA/AgNO3 (8.60 0.60 um). The average silver content measured was highest with 6.55% in EHA/Ag/2-layer followed by 3.92% in EHA/AgNO3, 0.38% in EHA/Ag and 0.10% in PHA/AgNO3. The electrochemical technique deposited a uniform coating onto the disc surface with clearly defined microcrystals as compared to the PHA-coated discs where the surface appeared smoother. The EHA coating, however, appeared less dense when compared with the PHA coating. DECLARATIONS
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引用次数: 2
An exploration of the relationship between placebo and homeopathy and the implications for clinical trial design. 探讨安慰剂与顺势疗法的关系及其对临床试验设计的启示。
Pub Date : 2013-07-30 DOI: 10.1177/2042533313490927
Claire Haresnape

Placebo appears to be a real neurobiological phenomenon that has evolved through the selection pressure to be able to heal ourselves. The complex language and social structures of humans means that we can attribute meaning to therapeutic encounters with culturally sanctioned authority figures and we can use our attachment to such figures to generate hope for recovery. Different mechanisms may be involved in the neurobiological aspect of placebo including anxiety, learning, conditioning as well as individual genetic variation. Examination of the published work shows that while some trials do seem to indicate a specific mode of action for homeopathic remedies other trials do not and this is an issue that needs to be addressed at the trial design stage. A clinical trial that includes both a placebo group and a non-participating control arm is the most powerful design for separating the non-specific and polymorphic placebo effect from the specific effects of trial medication. The control variables in a trial of homeopathic medication should also include the process of consultation as this may assume a meaning for the individual that can also be associated with a placebo effect.

安慰剂似乎是一种真实的神经生物学现象,它通过选择压力进化而来,从而能够治愈自己。人类复杂的语言和社会结构意味着,我们可以将与文化认可的权威人物的治疗性接触赋予意义,我们可以利用对这些人物的依恋来产生康复的希望。安慰剂的神经生物学方面可能涉及不同的机制,包括焦虑、学习、条件反射以及个体遗传变异。对已发表的研究表明,虽然一些试验似乎确实表明了顺势疗法的特定作用模式,但其他试验却没有,这是一个需要在试验设计阶段解决的问题。包括安慰剂组和非参与对照组的临床试验是将非特异性和多态安慰剂效应与试验药物的特异性效应分离开来的最有力的设计。顺势疗法药物试验中的控制变量还应包括咨询过程,因为这可能对个体具有意义,也可能与安慰剂效应有关。
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引用次数: 3
What drives the 'August effect'? A observational study of the effect of junior doctor changeover on out of hours work. 是什么推动了“八月效应”?初级医生更换对非工作时间工作影响的观察性研究。
Pub Date : 2013-07-05 eCollection Date: 2013-01-01 DOI: 10.1177/2042533313489823
John D Blakey, Andrew Fearn, Dominick E Shaw

Objective: To investigate whether measurements of junior doctor on-call workload and performance can clarify the mechanisms underlying the increase in morbidity and mortality seen after junior doctor changeover: the 'August effect'.

Design: Quantitative retrospective observational study of routinely collected data on junior doctor workload.

Setting: Two large teaching hospitals in England.

Participants: Task level data from a wireless out of hours system (n = 29,885 requests) used by medical staff, nurses, and allied health professionals.

Main outcome measures: Number and type of tasks requested by nurses, time to completion of tasks by junior doctors.

Results: There was no overall change in the number of tasks requested by nurses out of hours around the August changeover (median requests per hour 15 before and 14 after, p = 0.46). However, the number of tasks classified as urgent was greater (p = 0.016) equating to five more urgent tasks per day. After changeover, doctors took less time to complete tasks overall due to a reduction in time taken for routine tasks (median 74 vs. 66 min; p = 3.9 × 10(-9)).

Conclusion: This study suggests that the 'August effect' is not due to new junior doctors completing tasks more slowly or having a greater workload. Further studies are required to investigate the causes of the increased number of urgent tasks seen, but likely factors are errors, omissions, and poor prioritization. Thus, improved training and quality control has the potential to address this increased duration of unresolved patient risk. The study also highlights the potential of newer technologies to facilitate quantitative study of clinical activity.

目的:探讨初级医生值班工作量和工作表现的测量是否能阐明初级医生换岗后发病率和死亡率增加的机制:“八月效应”。设计:对常规收集的初级医生工作量数据进行定量回顾性观察研究。环境:英国两家大型教学医院。参与者:来自非工作时间无线系统的任务级数据(n = 29,885个请求),由医务人员、护士和专职卫生专业人员使用。主要观察指标:护士要求完成任务的数量和类型、初级医生完成任务的时间。结果:在8月转换前后,护士要求的非工作时间任务数量总体上没有变化(前15次,后14次,p = 0.46)。然而,紧急任务的数量更大(p = 0.016),相当于每天多5个紧急任务。转换后,由于常规任务所需的时间减少,医生完成任务所需的时间更少(中位数为74分钟vs 66分钟;p = 3.9 × 10(-9))。结论:本研究提示“八月效应”并不是因为新入职的初级医生完成任务较慢或工作量较大。需要进一步的研究来调查看到的紧急任务数量增加的原因,但可能的因素是错误、遗漏和不合理的优先级。因此,改进培训和质量控制有可能解决这种未解决的患者风险持续时间增加的问题。该研究还强调了促进临床活动定量研究的新技术的潜力。
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引用次数: 23
Neglected patellar tendon rupture. Reconstruction using semitendinosus-gracilis tendon grafts and FiberWire augmentation. 被忽视的髌骨肌腱断裂。半腱-股薄肌腱移植物和纤维线增强重建。
Pub Date : 2013-07-01 eCollection Date: 2013-01-01 DOI: 10.1177/2042533313490286
Konstantinos Tsitskaris, Padmanabhan Subramanian, David Crone
We describe an improved technique for the reconstruction of a neglected patellar tendon rupture, using semitendinosus-gracilis grafts and FiberWire augmentation.
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引用次数: 8
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JRSM short reports
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