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Improved survival of Danish cancer patients 2007-2009 compared with earlier periods. 与早期相比,2007-2009年丹麦癌症患者生存率提高。
Pub Date : 2011-12-01
Hans Henrik Storm, Anne Mette Tranberg Kejs, Gerda Engholm

Introduction: For the majority of cancers, improved long-term survival may be accessed from survival during the first year after diagnosis. A steady improvement in survival was seen both before and after the introduction of cancer control plans in 2000 and 2005. On the basis of data from 2007-2009, we studied the trend in 1-year survival after the introduction of the 2005 plan.

Material and methods: All cancers from 1995-2009 were studied in five 3-year cohorts of incident cases which were followed-up for death to the end of 2010. Age-standardised 1-, 3- and 5-year relative survival was calculated and 1-year survival presented for 2004-2006 and 2007-2009 to allow comparison with our previous publication.

Results: The improvement over time in overall 1-year age-standardised relative survival was maintained with a three percentage point increase to 72% for men and 75% for women. Exclusion of prostate and breast cancer from calculations lowered relative survival to 65% and 67%, respectively; but improvement was maintained. Cancer sites which previously enjoyed a high survival saw the least or no improvement as was the case for haematological cancers, except for non-Hodgkin lymphoma in men. The differences in survival between men and women are diminishing, especially for cancers of the digestive tract.

Conclusion: The improvements over time in survival after introduction of the cancer plans were maintained for non-haematological cancers. The fast-track system for diagnosis and treatment introduced gradually by cancer sites until the end of 2008 along with some centralisation of elective surgery may have narrowed the gap in cancer survival between men and women for digestive tract cancers and may also have improved survival for other cancers, e.g. the sex-specific types and kidney and brain cancers.

Funding: not relevant.

Trial registration: not relevant.

导读:对于大多数癌症,长期生存率的提高可以从诊断后第一年的生存率中获得。在2000年和2005年实施癌症控制计划之前和之后,生存率稳步提高。根据2007-2009年的数据,我们研究了2005年计划实施后的1年生存率趋势。材料和方法:对1995-2009年期间的所有癌症进行了5个为期3年的病例队列研究,随访至2010年底死亡。计算年龄标准化的1年、3年和5年相对生存率,并给出2004-2006年和2007-2009年的1年生存率,以便与我们之前的出版物进行比较。结果:随着时间的推移,总体1年年龄标准化相对生存率保持了改善,男性增加了3个百分点,达到72%,女性增加了75%。将前列腺癌和乳腺癌排除在计算之外,相对生存率分别降低至65%和67%;但改善仍在继续。除了男性非霍奇金淋巴瘤外,以前享有高存活率的癌症部位看到的改善最少或没有改善,就像血液学癌症一样。男性和女性之间的生存差异正在缩小,尤其是消化道癌症。结论:随着时间的推移,在引入癌症计划后,非血液学癌症的生存率得到了改善。到2008年底,由癌症地区逐步引入的诊断和治疗快速通道系统,以及一些选择性手术的集中,可能缩小了男性和女性在消化道癌症方面的生存差距,也可能改善了其他癌症的生存,例如性别特异性癌症、肾癌和脑癌。资金:不相关。试验注册:不相关。
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引用次数: 0
Communication with patients and colleagues. 与患者及同事沟通。
Pub Date : 2011-12-01
Birgitte Nørgaard

Background: Although patient-centred communication has provided a focus point in health care for many years, patient surveys continuously reveal serious communication problems as experienced by patients, due to poor communication. Likewise, poor inter-collegial communication can cause problems for both health care staff and patients. So, knowing that patient-centred communication and good inter-collegial communication is for the benefit of both health professionals and patients, the relevance of improving health care professionals' communication skills and investigating the effect on both professionals and patients is beyond doubt.

Aim: The aim of this study was to investigate whether a training course in communication skills for health care professionals could improve: 1) Health care professionals' self-efficacy in communication with patients and colleagues 2) Health care professionals' evaluation of inter-collegial communication 3) Patients' experience of quality of care, and to investigate health care professionals' experience of: a) participation in a communication skills training course b) the influence of the course on their ability to communicate with patients and colleagues.

Methods: The study was carried out in the Department of Orthopaedic Surgery, Kolding Hospital, a part of Lillebaelt Hospital, as an intervention study with baseline measurements and measurements after the intervention. The intervention was an in-house communication skills training course for all health care professionals at the department. The effect was measured partly on the health care professionals' self-efficacy and evaluation of inter-collegial communication, partly on patients' evaluation of quality of information, continuity and care. Data were collected by means of questionnaires and further explored by focus group interviews with health care professionals.

Results: A total of 181 health care professionals were included in the study. The questionnaire was completed by 177 (97.8%) before; 165/169 (97.6%) immediately after and 150/153 (98%) six months after the course. The health care professionals' self-efficacy was significantly increased, both for communication with patients and colleagues. The effect was still present six months after the training course. Also the health care professionals' evaluation of inter-collegial communication showed significant improvements after the course; the effect was more pronounced for inter-professional than for intra-professional communication and more pronounced six months after than immediately after the course. A total of 32 health care professionals participated in the focus group interviews, which showed that, in general, nurses, nursing assistants, medical secretaries and managers principally experienced better control over the patient interview, increased confidence in communication, improved inter-collegial understanding and i

背景:尽管以患者为中心的沟通多年来一直是医疗保健的一个重点,但患者调查不断显示,由于沟通不良,患者经历了严重的沟通问题。同样,糟糕的学院间沟通也会给医护人员和患者带来问题。因此,了解以患者为中心的沟通和良好的学院间沟通对卫生保健专业人员和患者都有好处,提高卫生保健专业人员的沟通技巧和调查对专业人员和患者的影响的相关性是毋庸置疑的。摘要目的:本研究旨在探讨卫生保健专业人员沟通技巧培训课程是否能提高卫生保健专业人员与患者和同事沟通的自我效能感、卫生保健专业人员对校际沟通的评价、卫生保健专业人员对护理质量的体验,并探讨卫生保健专业人员对以下方面的体验:A)参加沟通技巧培训课程b)该课程对他们与病人和同事沟通能力的影响。方法:本研究在Lillebaelt医院附属Kolding医院骨科进行,采用基线测量和干预后测量的干预研究。干预措施是为该部门所有保健专业人员举办的内部沟通技巧培训课程。其影响部分来自于医护人员的自我效能感和校际沟通的评价,部分来自于患者对信息质量、连续性和护理的评价。数据通过问卷收集,并通过与卫生保健专业人员的焦点小组访谈进一步探讨。结果:共有181名卫生保健专业人员被纳入研究。之前完成问卷177人(97.8%);165/169(97.6%)在课程结束后立即完成,150/153(98%)在课程结束后六个月完成。医护人员在与病人和同事沟通方面的自我效能感显著提高。这种效果在培训课程结束六个月后仍然存在。课程结束后,医护人员对校际沟通的评价也有显著提高;这种效果在专业人士之间的交流比专业人士之间的交流更明显,在课程结束后的六个月比课程结束后的六个月更明显。共有32名保健专业人员参加了焦点小组访谈,结果表明,总的来说,护士、护理助理、医务秘书和管理人员在培训课程后,对病人访谈的控制能力有所提高,对沟通的信心有所增强,学院间的理解有所改善,并更加注重以病人为中心的沟通。医生对参加培训课程的总体体验是负面的,但在课程结束后,他们的沟通经历了积极的变化。从2007年5月1日至2010年5月31日,共有3660名患者接受了问卷调查。基线测量的应答率为67.75%,后测量的应答率为77.63%。在15/19个问题中,回答“相当程度上”的患者显著增加;培训课程结束后,3/19个问题的得分无显著提高,1/19个问题的得分有统计学显著下降。结论:沟通技巧培训课程可以提高医护人员与病人和同事沟通的自我效能感,也可以改善学院间的沟通。焦点小组访谈显示,最重要的改变经验是与病人和同事更自信的沟通,并增加了以病人为中心。此外,该研究还表明,在卫生保健专业人员培训课程后,患者对信息、连续性和护理的满意度显著提高。
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引用次数: 0
Criteria-based emergency medical dispatch of ambulances fulfils goals. 基于标准的救护车紧急医疗调度实现了目标。
Pub Date : 2011-12-01
Mikkel Strømgaard Andersen, Helge Præstgaard Carlsen, Erika Frischknecht Christensen

Introduction: In Denmark, Alarm 112 (112) calls and emergency medical dispatch (EMD) are two separate institutions. 112 calls are mainly answered by the police. In Aarhus, a new EMD centre for the Region of Central Jutland (1.2 million people) opened on 1 December 2009. It was the first to employ health-care professionals and to use a new tool for criteria-based dispatch called Danish Index. The aim of the present paper is, for the first time in Denmark, to describe the level of urgency of patients transported by ambulance based on the Danish Index categories A-E and to determine if ambulance response time target values were reached.

Material and methods: The present paper is an observational cohort study based on consecutive, electronically collected data from the initial six months of operation (1 December 2009 to 31 May 2010) of the new EMD centre in Aarhus.

Results: A total of 73,484 patients were included. The distribution according to level of urgency was as follows: A 28.7% (n = 21,104), B 13.5% (n = 9,890), C 21.0% (n = 15,418), D 35.1% (n = 25,818), E 1.7% (n = 1,254). The median ambulance response time intervals for levels A and B were 6.5 and 11.9 min., respectively. Comparison of level A response time intervals with the equivalent target values showed that the 75, 92 and 98 percentiles were 10.0/10 min., 14.6/15 min., 18.6/20 min., respectively.

Conclusion: In a cohort of 73,484 patients, the highest level of urgency (A) was found in 28.7% of cases, while the largest group, 35.1% of patients, were level D cases - these patients had a need for transport, but not by ambulance. The level A target response time requested by 112 was achieved.

Funding: not relevant.

Trial registration: not relevant.

简介:在丹麦,112报警(112)电话和紧急医疗调度(EMD)是两个独立的机构。112报警电话主要由警方接听。在奥胡斯,为日德兰中部地区(120万人口)设立的一个新的EMD中心于2009年12月1日开业。它是第一个雇用保健专业人员并使用一种称为丹麦指数的基于标准的新工具的国家。本论文的目的是,在丹麦第一次,描述紧急程度的病人运送救护车基于丹麦指数类别A-E,并确定是否救护车响应时间目标值达到。材料和方法:本论文是一项观察性队列研究,基于奥胡斯新EMD中心运营的最初六个月(2009年12月1日至2010年5月31日)连续的电子收集数据。结果:共纳入73484例患者。按紧急程度分布为:A 28.7% (n = 21,104), B 13.5% (n = 9,890), C 21.0% (n = 15,418), D 35.1% (n = 25,818), E 1.7% (n = 1,254)。A级和B级的中位救护车反应时间间隔分别为6.5分钟和11.9分钟。A级反应时间间隔与等效目标值比较,75、92、98百分位分别为10.0/10 min、14.6/15 min、18.6/20 min。结论:在73,484例患者队列中,28.7%的病例为最高紧急程度(a级),而最大的组(35.1%)为D级病例,这些患者需要运输,但不需要救护车。达到了112所要求的A级目标响应时间。资金:不相关。试验注册:不相关。
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引用次数: 0
Cancer rates after kidney transplantation. 肾移植后的癌症发病率。
Pub Date : 2011-12-01
Ulrik Sodemann, Claus Bistrup, Peter Marckmann

Introduction: Previous studies demonstrated a 3-5-fold increased cancer risk in kidney allograft recipients compared with the general population. Our aim was to estimate cancer frequencies among kidney allograft recipients who were transplanted in 1997-2000 and who were immunosuppressed according to a more modern steroid-free standard protocol based on basixilimab, ciclosporine and mycophenolate mofetil.

Material and methods: This was a retrospective cohort study of patients receiving their first kidney allograft in 1997-2000 at Odense University Hospital, Denmark (n = 90). Histologically verified cancers were identified from a detailed search of the individual patient's medical records.

Results: During an average follow-up time of 8.4 years, a total of 14 cancers were observed. The cancer incidence rate was 18.5 (95% confidence interval (CI): 11.0-31.3) per 1,000 years, and the cancer prevalence was 13.4% (95% CI: 5.6-21.2%) among survivors in 2007. The relative risk of prevalent cancer was 3.6 (95% CI: 2.0-6.5) compared with the general population. Patients with cancer had a poorer survival than patients without cancer.

Conclusion: The observed cancer incidence rate and prevalence were similar to figures derived from studies performed in the earlier eras of kidney transplantation. Reducing cancer rates after kidney transplantation remains an important challenge for nephrologists.

Funding: not relevant.

Trial registration: not relevant.

先前的研究表明,与普通人群相比,肾移植受体的癌症风险增加了3-5倍。我们的目的是估计1997-2000年移植的异体肾移植受者的癌症发病率,这些受者根据基于basixilimab、环孢素和霉酚酸酯的更现代的无类固醇标准方案进行免疫抑制。材料和方法:这是一项回顾性队列研究,研究对象是1997-2000年在丹麦欧登塞大学医院接受首次肾移植的患者(n = 90)。组织学证实的癌症是通过详细搜索个体患者的医疗记录来确定的。结果:在平均8.4年的随访期间,共观察到14例癌症。2007年,癌症发病率为每1000年18.5例(95%可信区间(CI): 11.0-31.3),幸存者中癌症患病率为13.4% (95% CI: 5.6-21.2%)。与一般人群相比,流行癌症的相对风险为3.6 (95% CI: 2.0-6.5)。癌症患者的存活率比没有癌症的患者要低。结论:观察到的癌症发病率和患病率与早期肾移植研究得出的数据相似。降低肾移植后的癌症发病率仍然是肾病学家面临的一个重要挑战。资金:不相关。试验注册:不相关。
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引用次数: 0
Need for thyroidectomy in patients treated with radioactive iodide for benign thyroid disease. 放射性碘治疗良性甲状腺疾病患者甲状腺切除术的必要性
Pub Date : 2011-12-01
Mette Jegstrup Villadsen, Christian Hjort Sørensen, Christian Godballe, Birte Nygaard

Introduction: Nodular toxic and non-toxic goitres are seen in approximately 15% of Danish women, and the pros and cons of thyroidectomy versus radioiodine (RI) therapy are often discussed. The purpose of this study was to evaluate the type and number of patients treated on the indication of hyperthyroidism or benign goitre who did not achieve a sufficient effect of RI therapy and therefore needed thyroidectomy.

Material and methods: Between 1 January 2003 and 1 January 2008, a total of 873 patients were treated with RI on the indication of benign thyroid disease at Herlev Hospital (Denmark). Data concerning these patients were listed consecutively in a database. The data were subsequently cross-checked with the Danish Thyroid Surgery Quality Register (THYKIR) which contains data on all patients treated with thyroid surgery at Danish departments of ear, nose and throat and head and neck surgery since 1 January 2001. Patient data were also cross-checked with the National Patient Register data. The unique Danish social security numbers were used to compare data.

Results: Among the 873 patients treated with RI, 36 were listed in the THYKIR database. Eleven of these had primary thyroid surgery and subsequently underwent RI treatment due to goitre recurrence. Twenty-five patients first received RI therapy and subsequently thyroidectomy due to persisting symptoms (17 had non-toxic goitre and compression symptoms (among these eight had a large goitre with a thyroid volume of > 100 ml (range 100-389 ml)), five had nodular toxic goitre and three had diffuse toxic goitre and continuing hyperthyroidism despite RI treatment. Thyroid surgery revealed a small (2-3 mm) cancer in two patients, both from the group of patients with nodular toxic goitre.

Conclusion: The effect of RI therapy sufficiently solved the problem (hyperthyroidism or goitre) and surgery was hence avoided in 848 of 873 (97%) patients. However, within the group of patients with nontoxic goitre, a subgroup of patients with large goitres seems to be resistant to RI treatment and does not achieve sufficient effect under the current RI therapy regime.

Funding: not relevant.

Trial registration: Danish Data Protection Agency (Datatilsynet) HEH.afd.O.750.86-7 and 2010-231-0068.

简介:约15%的丹麦妇女可见结节性毒性和无毒甲状腺肿,甲状腺切除术与放射性碘(RI)治疗的利弊经常被讨论。本研究的目的是评估甲状腺功能亢进或良性甲状腺肿的适应症患者的类型和数量,这些患者在RI治疗中没有达到足够的效果,因此需要甲状腺切除术。材料和方法:2003年1月1日至2008年1月1日期间,共有873名患者在Herlev医院(丹麦)接受了甲状腺良性疾病指征的RI治疗。这些患者的资料被连续地列在一个数据库中。这些数据随后与丹麦甲状腺手术质量登记册(THYKIR)进行了交叉核对,该登记册载有2001年1月1日以来在丹麦耳、鼻、喉和头颈外科接受甲状腺手术治疗的所有患者的数据。患者数据也与国家患者登记数据进行了交叉核对。唯一的丹麦社会安全号码被用来比较数据。结果:在接受RI治疗的873例患者中,36例被列入THYKIR数据库。其中11例进行了原发性甲状腺手术,随后因甲状腺肿复发而接受了RI治疗。25例患者因持续症状(17例为无毒性甲状腺肿和压迫症状(其中8例为大甲状腺,甲状腺体积> 100 ml(范围100-389 ml)),首次接受RI治疗并随后接受甲状腺切除术,5例为结节性中毒性甲状腺肿,3例为弥漫性中毒性甲状腺肿,尽管接受了RI治疗,但仍持续甲状腺功能亢进。甲状腺手术发现两名患者有小的(2-3毫米)肿瘤,均来自结节性中毒性甲状腺肿患者组。结论:在873例(97%)患者中,有848例RI治疗充分解决了甲状腺功能亢进或甲状腺肿的问题,避免了手术。然而,在无毒甲状腺肿患者组中,有一组大甲状腺肿患者似乎对RI治疗有抵抗力,并且在目前的RI治疗方案下没有达到足够的效果。资金:不相关。试验注册:丹麦数据保护局(Datatilsynet) heh . afd.o.7500.86 -7和2010-231-0068。
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引用次数: 0
Guidelines for Percutaneous Dilatational Tracheostomy (PDT) from the Danish Society of Intensive Care Medicine (DSIT) and the Danish Society of Anesthesiology and Intensive Care Medicine (DASAIM). 来自丹麦重症医学会(DSIT)和丹麦麻醉与重症医学会(DASAIM)的经皮扩张性气管切开术(PDT)指南。
Pub Date : 2011-12-01
Kristian Rørbæk Madsen, Henrik Guldager, Mikael Rewers, Sven-Olaf Weber, Kurt Købke-Jacobsen, Reinhold Jensen

Percutaneous dilatational tracheostomy is a common procedure in intensive care. This guideline from the Danish Society of Intensive Care Medicine (DSIT) and the Danish Society of Anesthesiology and Intensive Care Medicine (DASAIM) describes indications and contraindications, timing, complications compared to surgical tracheostomy, anaesthesia and technique, decannulation strategy, as well as training and education.

经皮扩张性气管切开术是重症监护中的一种常见手术。该指南来自丹麦重症医学会(DSIT)和丹麦麻醉与重症医学会(DASAIM),描述了适应症和禁忌症、时机、与外科气管切开术相比的并发症、麻醉和技术、脱管策略以及培训和教育。
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引用次数: 0
Macrolide overuse for treatment of respiratory tract infections in general practice. 一般情况下大环内酯类药物治疗呼吸道感染的过度使用。
Pub Date : 2011-11-01
Mette Hinnerskov, Julie Maria Therkildsen, Gloria Cordoba, Lars Bjerrum

Introduction: High consumption of macrolides has been linked to increased macrolide resistance in the common pathogens of respiratory tract infections (RTIs). According to Danish recommendations, penicillin is the first-choice treatment for RTIs and macrolides should only be prescribed when a patient is allergic to penicillin or for treatment of mycoplasma pneumonias. The aim of the present study was to explore the prescription of macrolides for different RTIs to patients without penicillin allergy in general practice in Denmark.

Material and methods: This was a cross-sectional study. Data were collected during a three-week period in January 2008 as part of the EU-funded project Health Alliance for Prudent Prescribing, Yield and Use of Antimicrobial Drugs in the Treatment of Respiratory Tract Infections (HAPPY AUDIT). A total of 102 Danish general practitioners participated and registered patients with RTIs according to the Audit Project Odense method.

Results: A total of 3,904 patients with RTIs were registered and 1,351 patients received antibiotics. Among these, 198 patients received a macrolide. In all, 136 patients received a macrolide without being allergic to penicillin. This proportion was highest for patients diagnosed with acute otitis media (71%), acute bronchitis (71%) or pneumonia (76%).

Conclusion: Overall, there was a considerable overuse of macrolide for treatment of all types of RTIs. The macrolide overuse found in this study cannot be explained by the aetiology of Mycoplasma pneumoniae since there was no epidemic in 2008.

Funding: Data for the macrolide study were collected from the HAPPY AUDIT study which was funded by the EU. The two first-authors each received DKK 30,000 from the PLU foundation for their work on the article.

Trial registration: The HAPPY AUDIT method was registered and published in the BioMed Central.

大环内酯类药物的高消费与呼吸道感染(RTIs)常见病原体大环内酯类药物耐药性增加有关。根据丹麦的建议,青霉素是呼吸道感染的首选治疗药物,大环内酯类药物只有在患者对青霉素过敏或治疗肺炎支原体时才应开处方。本研究的目的是探讨大环内酯类药物的处方不同的RTIs患者在丹麦的一般做法没有青霉素过敏。材料和方法:本研究为横断面研究。数据是在2008年1月为期三周的时间内收集的,这是欧盟资助的用于治疗呼吸道感染的抗菌药物谨慎处方、产量和使用卫生联盟项目(HAPPY AUDIT)的一部分。根据审计项目欧登塞方法,共有102名丹麦全科医生参与并登记了rti患者。结果:共登记了3904例RTIs患者,其中1351例患者接受了抗生素治疗。其中,198例患者接受大环内酯类药物治疗。总共有136名患者接受了大环内酯治疗,但没有对青霉素过敏。在诊断为急性中耳炎(71%)、急性支气管炎(71%)或肺炎(76%)的患者中,这一比例最高。结论:总的来说,大环内酯类药物在治疗所有类型的RTIs中存在相当大的过度使用。本研究中发现的大环内酯类药物的过度使用不能用肺炎支原体的病原学来解释,因为2008年没有流行。资金:大环内酯研究的数据来自欧盟资助的HAPPY AUDIT研究。两位第一作者每人从PLU基金会获得了30,000丹麦克朗的报酬。试验注册:HAPPY审核方法已注册并在BioMed Central上发布。
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引用次数: 0
Uncertain added value of Global Trigger Tool for monitoring of patient safety in cancer care. 全球触发工具在癌症治疗中监测患者安全的附加价值不确定。
Pub Date : 2011-11-01
Henriette Lipczak, Kirsten Neckelmann, Marianne Steding-Jessen, Erik Jakobsen, Janne Lehmann Knudsen

Introduction: Monitoring patient safety is a challenging task. The lack of a golden standard has contributed to the recommendation and introduction of several methods. In 2000 the Danish Lung Cancer Registry (DLCR) was established to monitor the clinical management of lung cancer. In 2008 the Global Trigger Tool (GTT) was recommended in Denmark as a tool for the monitoring of patient safety. Ideally, the recommendation of a new tool should be preceded by a critical assessment of its added value.

Material and methods: Data on complications related to lung cancer surgery from the Department of Cardiothoragic Surgery at Odense University Hospital were collected using the DLCR and the GTT in 2008. The capacity of these two methods to identify complications is compared and discussed.

Results: A total of 59 complications were registered in the DLCR, while 58 complications were registered using the GTT. The two methods were equally good at identifying complications, but the DLCR seemed to be borderline significantly better at detecting arrhythmia, while the GTT was significantly better at detecting "other events".

Conclusion: Nearly half of the adverse events identified with the GTT were complications which were also registered by type in the DLCR. The two methods were almost equally good at identifying specific types of complications, but the GTT identified more "other events". The majority of these events were well-known to clinicians. The comparison illustrates why the implementation of new methods should be preceded by critical assessment. In this case, it is crucial to assess whether the current method should be modified by the addition of more patient safety indicators rather than by introducing a new method that partly duplicates existing data.

监测患者安全是一项具有挑战性的任务。由于缺乏黄金标准,因此推荐和引入了几种方法。2000年,丹麦肺癌登记处(DLCR)成立,以监测肺癌的临床管理。2008年,丹麦推荐全球触发工具(GTT)作为监测患者安全的工具。理想情况下,在推荐新工具之前,应该对其附加价值进行批判性评估。材料和方法:2008年使用DLCR和GTT收集欧登塞大学医院心胸外科肺癌手术相关并发症的数据。这两种方法识别并发症的能力进行了比较和讨论。结果:DLCR共记录59例并发症,GTT共记录58例并发症。两种方法在识别并发症方面同样出色,但DLCR在检测心律失常方面似乎明显更好,而GTT在检测“其他事件”方面明显更好。结论:GTT鉴定的不良事件中有近一半是并发症,并且在DLCR中也按类型记录。这两种方法在识别特定类型的并发症方面几乎同样出色,但GTT识别出更多的“其他事件”。这些事件大多数是临床医生所熟知的。这一比较说明了为什么在实施新方法之前应该进行严格的评估。在这种情况下,至关重要的是评估是否应该通过增加更多的患者安全指标来修改当前的方法,而不是引入一种部分重复现有数据的新方法。
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引用次数: 0
Modern treatment strategies in rheumatoid arthritis. 类风湿性关节炎的现代治疗策略。
Pub Date : 2011-11-01
Merete Lund Hetland

The main aim of the thesis was to evaluate the impact of modern treatment strategies on disease activity and disease course in patients with rheumatoid arthritis (RA), and to identify predictors for treatment response. Two different treatment strategies were investigated: (A) Aggressive, conventional treatment aiming at achieving inflammatory control in patients with recent-onset RA and (B) Treatment with tumour necrosis factor alpha (TNFα) inhibitors in patients with RA, who had an incomplete response to conventional treatment. (A) was studied in a randomized, placebo-controlled clinical trial (CIMESTRA), whereas (B) was investigated in an observational, nationwide cohort study (the DANBIO database). The main findings were: 1. Treatment strategy (A) with methotrexate (MTX) and injections of glucocorticoids into swollen joints had rapid and sustained effect and reduced disease activity and halted joint damage. Addition of cyclosporine during the first 2 years reduced disease activity for as long as it was given, but had no effect on the development of joint damage. After 5 years, the majority of the patients was in remission and had no progression of structural joint damage. 2. Bone marrow oedema by Magnetic resonance imaging (MRI) scans of the wrists predicted the development of structural joint damage 2 to 5 years later (based on x-rays). Anti-CCP antibodies and structural joint damage at the start of treatment were also independent predictors for joint damage after 5 years. 3. Routine registration of adverse events observed in patients who received treatment with etanercept or infliximab (TNFα inhibitors) in the DANBIO database picked up twice as many serious adverse events than the spontaneous, mandatory reports to the Danish Medicines Agency. 4. Despite changes in prescription practice for the treatment with TNFα inhibitors in clinical practice from year 2000 to year 2005 towards less stringent treatment criteria, DANBIO data showed an improved treatment response. 5. High age, low functional status and concomitant treatment with prednisolone were negative predictors of a EULAR good response and remission after 6 months of treatment with TNFα inhibitors in clinical practice. 6. In patients, who were naïve to treatment with TNFα inhibitors, significant differences between drugs were observed regarding treatment responses and adherence to therapies. Infliximab had the lowest treatment response, remission rates and adherence to therapy. Adalimumab had the highest treatment response and remission rates, whereas etanercept had the highest adherence. In conclusion, the results from the CIMESTRA trial and the DANBIO database showed that an aggressive treatment strategy with conventional drugs and intra-articular injections with betamethasone effectively controlled disease activity and prevent structural joint damage in patients with early RA. TNFα inhibitors were efficacious in clinical practice in the treatment of RA patien

本论文的主要目的是评估现代治疗策略对类风湿关节炎(RA)患者疾病活动和病程的影响,并确定治疗反应的预测因子。研究了两种不同的治疗策略:(A)积极的常规治疗,旨在控制新发RA患者的炎症;(B)对常规治疗反应不完全的RA患者使用肿瘤坏死因子α (TNFα)抑制剂治疗。(A)在一项随机、安慰剂对照临床试验(CIMESTRA)中进行研究,而(B)在一项观察性、全国性队列研究(DANBIO数据库)中进行研究。主要发现有:1。甲氨蝶呤(MTX)和向肿胀关节注射糖皮质激素的治疗策略(A)具有快速和持续的效果,可减少疾病活动并停止关节损伤。在头2年添加环孢素可以降低疾病活动性,但对关节损伤的发展没有影响。5年后,大多数患者病情缓解,无结构性关节损伤进展。2. 通过对手腕进行磁共振成像(MRI)扫描,骨髓水肿可以预测2至5年后(基于x射线)结构性关节损伤的发展。抗ccp抗体和治疗开始时的结构性关节损伤也是5年后关节损伤的独立预测因子。3.在DANBIO数据库中,接受依那西普或英夫利昔单抗(TNFα抑制剂)治疗的患者中观察到的不良事件的常规登记是自发的,强制性报告给丹麦药品管理局的不良事件的两倍。尽管从2000年到2005年,临床实践中使用TNFα抑制剂治疗的处方实践发生了变化,治疗标准变得不那么严格,但DANBIO数据显示治疗反应得到了改善。5. 在临床实践中,高年龄、低功能状态和同时使用强的松龙治疗是TNFα抑制剂治疗6个月后EULAR良好反应和缓解的阴性预测因素。6. 在接受TNFα抑制剂治疗naïve的患者中,观察到药物之间在治疗反应和治疗依从性方面的显着差异。英夫利昔单抗的治疗反应、缓解率和治疗依从性最低。阿达木单抗具有最高的治疗反应和缓解率,而依那西普具有最高的依从性。总之,CIMESTRA试验和DANBIO数据库的结果表明,常规药物和关节内注射倍他米松的积极治疗策略有效地控制了早期RA患者的疾病活动并预防了结构性关节损伤。TNFα抑制剂在常规治疗失败的RA患者的临床实践中是有效的。发现TNFα抑制剂在疗效和药物依从性方面存在差异。确定病程和治疗反应的预测因子。
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引用次数: 0
Validation of the Danish version of Oxford Shoulder Score. 丹麦版牛津肩谱的验证。
Pub Date : 2011-11-01
Lars Henrik Frich, Peter Moensted Noergaard, Stig Brorson

Introduction: The Oxford Shoulder Score (OSS) is a patient-administered condition-specific questionnaire for patients with degenerative or inflammatory shoulder disease. The purpose of this study was to validate a Danish translation of the OSS and to compare it with the Constant Score (CS).

Material and methods: A total of 102 consecutive patients referred to our shoulder unit were recruited for the study. The OSS was translated into Danish according to recommendations presented by Guillemin and co-workers. We established the psychometric properties of the scoring system. Test-retest reliability was assessed by inviting 32 patients to complete another OSS 72 hours after the first test. The Bland-Altman plot was used to show absolute differences between test and retest.

Results: The validity expressed as a Spearman's rank correlation coefficient comparing the OSS with the CS was 0.74. The test-retest reliability correlation coefficient was 0.98. Bland-Altman plots revealed limits of agreement between the scores of -4.5 and -5.4. Internal consistency tested by Cronbach's alpha was 0.93.

Conclusion: The psychometric properties of the Danish version of OSS showed good validity and reliability with a substantial correlation between the OSS and the CS. Internal consistency was high. The OSS is recommended for the evaluation of patients with degenerative or post-traumatic shoulder diseases.

Funding: not relevant.

Trial registration: not relevant.

简介:牛津肩部评分(OSS)是一项针对退行性或炎症性肩关节疾病患者的患者管理的条件特异性问卷。本研究的目的是验证OSS的丹麦语翻译,并将其与恒定评分(CS)进行比较。材料和方法:研究共招募了102例转介至我们肩关节部的连续患者。根据Guillemin及其同事提出的建议,OSS被翻译成丹麦语。我们建立了评分系统的心理测量特性。通过邀请32名患者在第一次测试后72小时完成另一次OSS来评估重测可靠性。Bland-Altman图用于显示检验与复验之间的绝对差异。结果:OSS与CS比较的效度以Spearman等级相关系数表示为0.74。重测信度相关系数为0.98。布兰德-奥特曼图显示,-4.5和-5.4的分数之间存在一定的一致性。内部一致性经Cronbach's alpha检验为0.93。结论:丹麦版OSS的心理测量特性具有良好的效度和信度,OSS与CS具有显著的相关性。内部一致性高。OSS被推荐用于评估退行性或创伤后肩关节疾病患者。资金:不相关。试验注册:不相关。
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引用次数: 0
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Danish medical bulletin
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