GMS German Medical Science最新文献_第3页

Subgroups in chronic low back pain patients – a step toward cluster-based, tailored treatment in inpatient standard care: On the need for precise targeting of treatment for chronic low back pain 慢性腰痛患者的亚组——在住院标准护理中向基于集群、量身定制的治疗迈出的一步：关于慢性腰痛治疗的精确靶向性的必要性

Q1 Medicine

GMS German Medical Science

Pub Date : 2019-09-11 DOI: 10.3205/000275

Anna-Maria Langenmaier, V. Amelung, M. Karst, C. Krauth, F. Püschner, D. Urbanski, C. Schiessl, R. Thoma, B. Klasen

Objective: The purpose of this study was to find applicable clusters for the development of different treatment pathways in an inpatient multimodal pain-therapy setting based on the multifaceted nature of CLBP. Methods: Based on data of questionnaires (Hospital Anxiety and Depression Scale (HADS), Marburg Questionnaire on Habitual Health Findings (MFHW), quality of life assessment using the Short-Form 12 (SF 12)), a retrospective two-step cluster analysis involving a sample of chronic low back pain (CLBP) patients (N=320) was calculated. Subsequently, the clusters were precisely described and compared on the basis of further data collected during the patients’ standard care: pain characteristics, socio-demographic data and the general state of health, psychological variables, therapy intensity, and Diagnosis Related Groups (DRG) data. Results: We found a three-cluster solution: little psychological interference but marginal physical and mental quality of life (Cluster 1); poor well-being, low physical quality of life, and marginal mental quality of life (Cluster 2); and heavy mental strain and marginal physical quality of life (Cluster 3). Conclusions: Similar to previous studies, our results suggest that patients suffering from CLBP differ with regard to the magnitude of mental burden and the presence of physical impairment. These differences ascertain the need for precise targeting of treatment for CLBP. Inpatient pain centers therefore should offer different multimodal therapy pathways and integrate a meaningful triage, taking into account the multifaceted nature of CLBP based on sophisticated knowledge about forms, differences, and relationships among the biopsychosocial components of CLBP.

目的：本研究的目的是基于CLBP的多方面性质，寻找适用于在住院多模式疼痛治疗环境中开发不同治疗途径的集群。方法：根据医院焦虑抑郁量表（HADS）、马尔堡习惯健康调查问卷（MFHW）、简式12生活质量评估（SF 12）等问卷资料，对320例慢性腰痛（CLBP）患者进行回顾性两步聚类分析。随后，在患者标准护理期间收集的进一步数据的基础上，对集群进行了精确描述和比较：疼痛特征、社会人口统计数据和一般健康状况、心理变量、治疗强度和诊断相关组（DRG）数据。结果：我们发现了一个三类解决方案：心理干扰很小，但身心生活质量很差（第1类）；幸福感差，身体生活质量低，精神生活质量差（第2组）；精神压力大，身体生活质量差（第3组）。结论：与之前的研究类似，我们的研究结果表明，CLBP患者在精神负担和身体损伤方面存在差异。这些差异确定了对CLBP进行精确靶向治疗的必要性。因此，住院疼痛中心应提供不同的多模式治疗途径，并整合有意义的分诊，基于对CLBP的生物-心理-社会组成部分之间的形式、差异和关系的复杂知识，考虑到CLBP的多方面性质。

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引用次数: 8

Poor, old and in need of care: A qualitative study about the consequences for home care and participation 穷人、老人和需要照顾:一项关于家庭照顾和参与后果的定性研究

Q1 Medicine

GMS German Medical Science

Pub Date : 2019-08-09 DOI: 10.3205/000274

M. Messer

Background: For people in old age and in need of care, there is an increased risk of being affected by poverty. The aim of the study was to explore the forms of poverty that nurses in Germany perceive in older people in need of care who are living at home, as well as the perceived strategies to deal with this situation regarding health and nursing care and the consequences for the possibilities of participation. Methods: A qualitative study was performed as a secondary data analysis of 39 transcribed problem-oriented expert interviews. The data analysis was conducted through content and thematic analysis. Results: Two forms of poverty among people in need of care were described by the nurses interviewed: 1) a self-imposed austerity, and 2) a material and financial poverty. The possible consequences of poverty reported in those in need of care are harmful self-restrictions and limited opportunities for participation, e.g. through the multiple use of medical aids and reduced intake of medications, but also restricted food intake. This situation is often accepted without complaint by people in need of care. However, restrictions in social activities can be a considerable burden on the quality of life of patients. The interviewees described that offering professional help can be challenging, because people in need of care and affected by poverty often show a degree of high shame in accepting financial support or negate their own precarious life situation, but also because support structures in the social and health system are limited. Conclusion: The results indicate how older people in need of care impose self-restrictions due to their poverty, which are harmful to health and limit the quality of life. Furthermore, the described strategies can pose a significant risk to the medical safety of patients. This has implications for the nursing and social care, but also for the medical treatment of the affected patients. The existing support systems seem to be only partially prepared for dealing with such situations. In view of a trend towards an older population structure, future research should put more emphasis on the user-friendly adaptation of the social and health systems. Strategies to prevent and deal with poverty in older people in need of care, easy access to social support systems, as well as the preparation of the health professions for the associated tasks seem to be particularly indicated.

背景：对于老年人和需要护理的人来说，受贫困影响的风险增加了。这项研究的目的是探讨德国护士对居住在家中的需要护理的老年人的贫困形式，以及在健康和护理方面应对这种情况的策略，以及参与的可能性的后果。方法：对39次转录的以问题为导向的专家访谈进行定性研究，作为二次数据分析。数据分析是通过内容和主题分析进行的。结果：受访护士描述了需要护理的人的两种贫困形式：1）自我实施的紧缩，以及2）物质和经济贫困。据报道，贫困对需要护理的人可能造成的后果是有害的自我限制和有限的参与机会，例如多次使用医疗辅助工具和减少药物摄入，但也限制了食物摄入。这种情况经常被需要护理的人毫无怨言地接受。然而，社交活动的限制可能会对患者的生活质量造成相当大的负担。受访者表示，提供专业帮助可能具有挑战性，因为需要护理和受贫困影响的人在接受经济支持或否定自己不稳定的生活状况时往往表现出高度的羞耻感，但也因为社会和卫生系统的支持结构有限。结论：研究结果表明，需要护理的老年人由于贫困而施加自我限制，这对健康有害，并限制了生活质量。此外，所描述的策略可能对患者的医疗安全构成重大风险。这对护理和社会护理有影响，也对受影响患者的医疗有影响。现有的支助系统似乎只是为处理这种情况做了部分准备。鉴于人口结构趋于老龄化的趋势，今后的研究应更加重视对社会和卫生系统进行方便用户的调整。似乎特别指出了预防和处理需要护理的老年人贫困、方便获得社会支持系统以及卫生专业人员为相关任务做好准备的战略。

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引用次数: 11

Prevention of inadvertent perioperative hypothermia – Guideline compliance in German hospitals 预防意外围手术期体温过低-德国医院指南依从性

Q1 Medicine

GMS German Medical Science

Pub Date : 2019-07-26 DOI: 10.3205/000273

P. Gabriel, J. Höcker, M. Steinfath, Kevin R. Kutschick, Jana Lubinska, E. Horn

Patients undergoing elective surgery are at risk for inadvertent postoperative hypothermia, defined as a core body temperature below 36°C. This study was conducted to investigate the acceptance of the recommendations of the German S3 Guideline, in particular with respect to the concept of pre-warming and sublingual temperature measurement. The main focus was to gather data concerning the postoperative core temperature and the frequency of perioperative hypothermia in patients receiving a pre-warming regime and those without. The study team investigated the local concept and measures employed to avoid inadvertent perioperative hypothermia with respect to defined outcome parameters following a specific protocol. In summary, the study hospitals vary greatly in their perioperative processes to prevent postoperative hypothermia. However, each hospital has a strategy to prevent hypothermia and was more or less successful in keeping its patients normothermic during the perioperative process. Our data could not demonstrate major differences between hospitals in the implementation strategy to prevent perioperative hypothermia in regard to the hospital size. The results of our study suggest a wide-spread acceptance, as no postoperative hypothermia was detected in a cohort of 431 patients.

接受选择性手术的患者有意外发生术后体温过低的风险，即核心体温低于36°C。本研究旨在调查是否接受德国S3指南的建议，特别是关于预热和舌下温度测量的概念。主要关注的是收集关于接受预热方案和未接受预热方案的患者术后核心温度和围手术期体温过低频率的数据。研究小组根据特定方案确定的结果参数，调查了避免意外围手术期体温过低的局部概念和措施。总之，研究医院在预防术后体温过低的围手术期过程中差异很大。然而，每家医院都有预防体温过低的策略，并且在围手术期或多或少成功地保持了患者的体温正常。我们的数据无法证明医院在预防围手术期体温过低的实施策略方面存在重大差异。我们的研究结果表明广泛接受，因为在431名患者的队列中没有检测到术后体温过低。

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引用次数: 10

Continuous chest compressions with a simultaneous triggered ventilator in the Munich Emergency Medical Services: a case series. 慕尼黑紧急医疗服务中心使用同时触发的呼吸机进行连续胸外按压：一系列病例。

Q1 Medicine

GMS German Medical Science

Pub Date : 2019-06-26 eCollection Date: 2019-01-01 DOI: 10.3205/000272

Stefan J Schaller, Sonja Altmann, Annalise Unsworth, Gerhard Schneider, Viktoria Bogner-Flatz, Thomas Paul, Petra Hoppmann, Karl-Georg Kanz

Background: Mechanical chest compression devices are commonly used providing a constant force and frequency of chest compression during cardiopulmonary resuscitation. However, there are currently no recommendations on ventilation during cardiopulmonary resuscitation with a mechanical chest compression device using continuous mode. An effective method for ventilation in such scenarios might be a triggered oxygen-powered resuscitator. Methods: We report seven cardiopulmonary resuscitation cases from the Munich Emergency Medical Service where mechanical chest compression devices in continuous mode were used with an oxygen-powered resuscitator. In each case, the resuscitator (Oxylator^®) was running in automatic mode delivering a breath during the decompression phase of the chest compressions at a frequency of 100 per minute. End-tidal carbon dioxide and pulse oximetry were measured. Additional data was collected from the resuscitation protocol of each patient. Results: End-tidal carbon dioxide was available in all cases while oxygen saturation only in four. Five patients had a return of spontaneous circulation. Based on the end-tidal carbon dioxide values of each of the cases, the resuscitator did not seem to cause hyperventilation and suggests that good-quality cardiopulmonary resuscitation was delivered. Conclusions: Continuous chest compressions using a mechanical chest compression device and simultaneous synchronized ventilation using an oxygen-powered resuscitator in an automatic triggering mode might be feasible during cardiopulmonary resuscitation.

背景：在心肺复苏过程中，机械胸部按压装置通常用于提供恒定的胸部按压力和频率。然而，目前还没有关于使用连续模式的机械胸部按压装置进行心肺复苏期间的通气的建议。在这种情况下，一种有效的通气方法可能是触发式氧气复苏器。方法：我们报告了来自慕尼黑急救医疗服务中心的7例心肺复苏病例，其中连续模式的机械胸部按压装置与氧气动力复苏器一起使用。在每种情况下，复苏器（Oxylator®）都在自动模式下运行，在胸外按压的减压阶段以每分钟100次的频率进行呼吸。测量潮末二氧化碳和脉搏血氧计。从每位患者的复苏方案中收集了额外的数据。结果：潮末二氧化碳在所有情况下都可用，而氧饱和度只有四种情况。5名患者恢复了自主循环。根据每个病例的潮气末二氧化碳值，复苏器似乎没有引起过度换气，这表明进行了高质量的心肺复苏。结论：在心肺复苏过程中，使用机械胸外按压装置进行连续胸外按压和使用自动触发模式的氧气复苏器同时同步通气可能是可行的。

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引用次数: 6

Management of pain in individuals with spinal cord injury: Guideline of the German-Speaking Medical Society for Spinal Cord Injury 脊髓损伤患者疼痛的处理:德语脊髓损伤医学协会指南

Q1 Medicine

GMS German Medical Science

Pub Date : 2019-06-17 DOI: 10.3205/000271

S. Franz, B. Schulz, Haili Wang, Sabine Gottschalk, Florian Grüter, Jochen Friedrich, J. Glaesener, F. Bock, C. Schott, Rachel Müller, Kevin Schultes, G. Landmann, H. Gerner, V. Dietz, R. Treede, N. Weidner

Introduction: Pain is a prominent complication in spinal cord injury (SCI). It can either occur as a direct or as an indirect consequence of SCI and it often heavily influences the quality of life of affected individuals. In SCI, nociceptive and neuropathic pain can equally emerge at the same time above or below the level of injury. Thus, classification and grading of pain is frequently difficult. Effective treatment of SCI-related pain in general and of neuropathic pain in particular is challenging. Current treatment options are sparse and their evidence is considered to be limited. Considering these aspects, a clinical practice guideline was developed as basis for an optimized, comprehensive and standardized pain management in SCI-related pain. Methods: The German-Speaking Medical Society for Spinal Cord Injury (Deutschsprachige Medizinische Gesellschaft für Paraplegiologie – DMGP) developed a clinical practice guideline that received consensus from seven further German-speaking medical societies and one patient organization. The evidence base from clinical trials and meta-analyses was summarized and subjected to a structured consensus-process in accordance with the regulations of the Association of Scientific Medical Societies in Germany (AWMF) and the methodological requirements of the “German instrument for methodological guideline appraisal”. Results: This consensus-based guideline (S2k classification according to the AWMF guidance manual and rules) resulted in seven on-topic statements and 17 specific recommendations relevant to the classification, assessment and therapy of pain directly or indirectly caused by SCI. Recommended therapeutic approaches comprise pharmacological (e.g. nonsteroidal anti-inflammatory drugs or anticonvulsants) and non-pharmacological (e.g. physical activity or psychotherapeutic techniques) strategies for both nociceptive and neuropathic pain. Discussion: Assessment of SCI-related pain is standardized and respective methods in terms of examination, classification and grading of pain are already in use and validated in German language. In contrast, valid, evidence-based and efficient therapeutic options are limited and ask for further clinical studies, ideally randomized controlled trials and meta-analyses.

引言：疼痛是脊髓损伤（SCI）的一个突出并发症。它可以作为SCI的直接或间接后果发生，通常严重影响受影响个体的生活质量。在SCI中，伤害性疼痛和神经性疼痛可以在损伤程度以上或以下同时出现。因此，疼痛的分类和分级通常是困难的。有效治疗脊髓损伤相关疼痛，尤其是神经性疼痛是具有挑战性的。目前的治疗选择很少，其证据被认为是有限的。考虑到这些方面，制定了一份临床实践指南，作为SCI相关疼痛的优化、全面和标准化疼痛管理的基础。方法：讲德语的脊髓损伤医学会（Deutschesprachige Medizinische Gesellschaft für Paradispolologie–DMGP）制定了一项临床实践指南，该指南得到了另外七个讲德语的医学会和一个患者组织的一致同意。根据德国科学医学会协会（AWMF）的规定和“德国方法指南评估工具”的方法要求，总结了临床试验和荟萃分析的证据基础，并对其进行了结构化的共识过程。结果：这项基于共识的指南（根据AWMF指南手册和规则进行S2k分类）产生了7项主题声明和17项与SCI直接或间接引起的疼痛的分类、评估和治疗相关的具体建议。推荐的治疗方法包括针对伤害性疼痛和神经性疼痛的药理学（如非甾体抗炎药或抗惊厥药）和非药理学（如身体活动或心理治疗技术）策略。讨论：SCI相关疼痛的评估是标准化的，疼痛的检查、分类和分级方面的相应方法已经在使用，并在德语中得到了验证。相比之下，有效、循证和有效的治疗选择是有限的，需要进一步的临床研究，最好是随机对照试验和荟萃分析。

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引用次数: 13

Current practice and perspectives in CRO oversight based on a survey performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa) 基于对德国研究型制药公司协会(vfa)成员进行的一项调查，CRO监管的当前实践和观点

Q1 Medicine

GMS German Medical Science

Pub Date : 2017-01-26 DOI: 10.3205/000243

M. Hennig, F. Hundt, Susanne Busta, Stefan Mikus, Per-Holger Sanden, Andrea Sörgel, T. Ruppert

In recent years, the number and scope of outsourced activities in the pharmaceutical industry have increased heavily. In addition, also the type of outsourcing has changed significantly in that time. This raises the question of whether and how sponsors retain the capability to select and to control the contract research organizations (CROs) involved and what expertise still has to be present in the development department as well as other relevant departments to ensure adequate oversight, also in line with the expectations of regulators and health authorities. In order to answer these questions, a survey was conducted among the German vfa member companies. The survey describes the latest developments and experiences in outsourcing by 18 German vfa member companies. It concentrates on measures how to implement Quality Assurance (QA) when performing outsourced clinical studies. This study shows that the majority of companies apply a full-outsourcing, preferred-provider model of clinical trial services, with the clinical research department playing the major role in this process. A large amount of guiding documents, processes and tools are used to ensure an adequate oversight of the services performed by the CRO(s). Finally the guiding principles for all oversight processes should be transparent communication, a clearly established expectation for quality, a precise definition of accountability and responsibility while avoiding silo mentality, and a comprehensive documentation of the oversight’s evidence. For globally acting and outsourcing sponsors, oversight processes need to be aligned with regards to local and global perspectives. This survey shows that the current implementation of oversight processes in the participating companies covers all relevant areas to ensure highest quality and integrity of the data produced by the outsourced clinical trial.

近年来，制药行业外包活动的数量和范围大大增加。此外，外包的类型也在那个时候发生了很大的变化。这就提出了一个问题，即资助方是否以及如何保留选择和控制所涉及的合同研究组织(cro)的能力，以及开发部门和其他相关部门仍然需要哪些专门知识来确保充分的监督，也符合监管机构和卫生当局的期望。为了回答这些问题，我们在德国vfa会员公司中进行了一项调查。该调查描述了18家德国vfa成员公司在外包方面的最新发展和经验。它集中于在进行外包临床研究时如何实施质量保证(QA)的措施。本研究表明，大多数企业的临床试验服务采用全外包、首选提供者模式，临床研究部门在这一过程中起着主要作用。我们使用了大量的指导性文件、程序和工具，以确保对投诉专员所提供的服务进行充分的监督。最后，所有监督过程的指导原则应该是透明的沟通、对质量的明确期望、对责任和责任的精确定义，同时避免筒仓思维，以及对监督证据的全面记录。对于全球行动和外包发起人来说，监督过程需要与本地和全球视角保持一致。该调查显示，参与公司目前实施的监督流程涵盖了所有相关领域，以确保外包临床试验产生的数据的最高质量和完整性。

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引用次数: 4

The prevalence of chronic pain in orchestra musicians 管弦乐队音乐家慢性疼痛的患病率

Q1 Medicine

GMS German Medical Science

Pub Date : 2017-01-12 DOI: 10.3205/000242

E. Gasenzer, Marie-Juliana Klumpp, D. Pieper, E. Neugebauer

Background: The study investigated the incidence of chronic pain as well as causes and mechanisms of pain chronification in orchestra musicians. Aims: Chronic pain is a serious problem in the study group due to very specific playing techniques and body positions while playing, with a high impact on professional and private life. Methods: 8,645 professional musicians from 132 German cultural orchestras were contacted and asked about chronic pain via an online questionnaire. The study group comprised orchestra musicians suffering from pain. The control group consisted of musicians playing the same type of instruments (same working conditions) who reported to be free of pain. Results: The response rate was 8.6% (740 musicians). 66.2% (n=490) out of 740 musicians who completed the questionnaire reported chronic pain. The most frequently reported localizations of pain were the body parts which are mostly involved in instrumental playing such as back (70%), shoulders (67.8%), neck (64.1%), hands and wrists (39.8%). 27.4% of the investigated musicians suffered from pain with a high degree of impairment. Conclusions: These results appear conclusive and indicate a need to continue research into chronic pain in musicians.

背景：本研究调查了管弦乐队音乐家慢性疼痛的发生率以及疼痛慢性化的原因和机制。目的：慢性疼痛是研究组中的一个严重问题，因为在比赛中有非常具体的比赛技术和身体姿势，对职业和私人生活有很大影响。方法：通过在线问卷调查，联系来自132个德国文化管弦乐队的8645名专业音乐家，询问他们的慢性疼痛问题。研究小组由饱受疼痛折磨的管弦乐队音乐家组成。对照组由演奏相同类型乐器（相同工作条件）的音乐家组成，他们报告没有疼痛。结果：有效率为8.6%（740名音乐家）。在完成问卷调查的740名音乐家中，66.2%（n=490）的人报告了慢性疼痛。最常见的疼痛部位是主要参与乐器演奏的身体部位，如背部（70%）、肩部（67.8%）、颈部（64.1%）、手和手腕（39.8%）。27.4%的受访音乐家患有高度损伤的疼痛。结论：这些结果似乎是决定性的，表明有必要继续研究音乐家的慢性疼痛。

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引用次数: 21

TST36 stapling for rectocele and hemorrhoidal prolapse – early results of the prospective German multicenter study TST36吻合器治疗直肠膨出和痔疮脱垂——德国前瞻性多中心研究的早期结果

Q1 Medicine

GMS German Medical Science

Pub Date : 2016-12-19 DOI: 10.3205/000241

S. Petersen, D. Sterzing, A. Ommer, A. Mladenov, Z. Nakic, F. Pakravan, K. Wolff, E. Lorenz, R. Prosst, M. Sailer, R. Scherer

Introduction: The aim of the study was to evaluate the safety and feasibility of stapled transanal procedures performed by a 36 mm stapling device, the so-called TST36 stapler. Methods: From September 2013 to June 2014 a prospective observational study was carried out by 8 proctology centers in Germany. The Cleveland Clinic Incontinence Score (CCIS) for incontinence and the Altomare ODS score were determined preoperatively. Follow-up examinations were performed after 14 days, one month and 6 months, at this time both scores were reevaluated. Results: 110 consecutive patients (71 women, 39 men) with a mean age of 59.7 years (±13.8 years) were included in the study. The eight participating institutes entered 3 to 31 patients each into the study. The indication for surgery was an advanced hemorrhoidal disease in 55 patients and ODS with rectal intussusception or rectocele in 55 patients. Mechanical problems with stapler introduction occurred in 22 cases (20%) and a partial stapleline dehiscence in 4 cases (3.6%). Additional stitches for bleeding from stapleline were necessary in 86 patients (78.2%). Reintervention was necessary for bleeding 7 times (6.3%). Severe complications during follow-up were stapleline dehiscence in one case and recurrent hemorrhoidal prolapse in 5 cases (4.5%). Altomare ODS score and CCIS improved significantly after surgery. Conclusions: Despite a notable complication rate during surgery and the postoperative period, the TST36 can be considered as an effective tool for low rectal stapling for anorectal prolapse causing hemorrhoids or obstructed defecation.

简介:本研究的目的是评估使用36mm吻合器(TST36吻合器)进行经肛门吻合器手术的安全性和可行性。方法:2013年9月至2014年6月在德国8家直肠科中心进行前瞻性观察研究。术前测定尿失禁的Cleveland Clinic Incontinence Score (CCIS)和Altomare ODS评分。随访时间分别为14天、1个月和6个月，此时重新评估两组评分。结果:连续纳入110例患者，其中女性71例，男性39例，平均年龄59.7岁(±13.8岁)。8家参与研究的机构各将3至31名患者纳入研究。手术指征为55例晚期痔疮疾病和55例ODS合并直肠肠套叠或直肠膨出。22例(20%)订书机引入时出现机械问题，4例(3.6%)订书机线部分开裂。有86例(78.2%)患者因缝线出血需要额外缝针。出血7次(6.3%)需要再干预。随访中出现的严重并发症有镫骨线裂开1例，复发性痔疮脱垂5例(4.5%)。术后Altomare ODS评分和CCIS均有明显改善。结论:TST36在术中及术后并发症发生率较高，可作为低位直肠吻合术治疗肛肠脱垂致痔疮或排便不遂的有效工具。

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引用次数: 3

Quality of care in patients with atrial fibrillation in primary care: a cross-sectional study comparing clinical and claims data. 基层医疗机构对心房颤动患者的护理质量：一项比较临床数据和索赔数据的横断面研究。

Q1 Medicine

GMS German Medical Science

Pub Date : 2016-11-23 eCollection Date: 2016-01-01 DOI: 10.3205/000240

Rebekka Preuss, Jean-François Chenot, Aniela Angelow

Objectives: Atrial fibrillation (AF) is a common cardiac arrhythmia with increased risk of thromboembolic stroke. Oral anticoagulation (OAC) reduces stroke risk by up to 68%. The aim of our study was to evaluate quality of care in patients with AF in a primary health care setting with a focus on physician guideline adherence for OAC prescription and heart rate- and rhythm management. In a second step we aimed to compare OAC rates based on primary care data with rates based on claims data. Methods: We included all GP practices in the region Vorpommern-Greifswald, Germany, which were willing to participate (N=29/182, response rate 16%). Claims data was derived from the regional association of statutory health insurance physicians. Patients with a documented AF diagnosis (ICD-10-GM-Code ICD I48.-) from 07/2011-06/2012 were identified using electronic medical records (EMR) and claims data. Stroke and bleeding risk were calculated using the CHA₂DS₂-VASc and HAS-BLED scores. We calculated crude treatment rates for OAC, rate and rhythm control medications and adjusted OAC treatment rates based on practice and claims data. Adjusted rates were calculated including the CHA₂DS₂-VASc and HAS-BLED scores and individual factors affecting guideline based treatment. Results: We identified 927 patients based on EMR and 1,247 patients based on claims data. The crude total OAC treatment rate was 69% based on EMR and 61% based on claims data. The adjusted OAC treatment rates were 90% for patients based on EMR and 63% based on claims data. 82% of the AF patients received a treatment for rate control and 12% a treatment for rhythm control. The most common reasons for non-prescription of OAC were an increased risk of falling, dementia and increased bleeding risk. Conclusion: Our results suggest that a high rate of AF patients receive a drug therapy according to guidelines. There is a large difference between crude and adjusted OAC treatment rates. This is due to individual contraindications and comorbidities which cannot be documented using ICD coding. Therefore, quality indicators based on crude EMR data or claims data would lead to a systematic underestimation of the quality of care. A possible overtreatment of low-risk patients cannot be ruled out.

目的：心房颤动（房颤）是一种常见的心律失常，会增加血栓栓塞性中风的风险。口服抗凝药（OAC）可将中风风险降低 68%。我们的研究旨在评估初级医疗机构中房颤患者的护理质量，重点关注医生是否遵守了 OAC 处方及心率和心律管理指南。第二步，我们旨在将基于初级医疗数据的 OAC 使用率与基于索赔数据的 OAC 使用率进行比较。方法：我们纳入了德国前波美拉尼亚-格赖夫斯瓦尔德地区所有愿意参与的全科医生诊所（N=29/182，响应率 16%）。理赔数据来自地区法定医疗保险医生协会。通过电子病历（EMR）和理赔数据确定了在 2011 年 7 月至 2012 年 6 月期间有房颤诊断记录（ICD-10-GM 代码 ICD I48.-）的患者。使用 CHA2DS2-VASc 和 HAS-BLED 评分计算卒中和出血风险。我们计算了 OAC、心率和节律控制药物的粗治疗率，并根据实践和理赔数据调整了 OAC 治疗率。我们计算了调整后的治疗率，包括 CHA2DS2-VASc 和 HAS-BLED 评分以及影响指南治疗的个别因素。结果：我们根据 EMR 确定了 927 名患者，根据索赔数据确定了 1247 名患者。根据 EMR 和索赔数据，粗略的 OAC 总治疗率分别为 69% 和 61%。根据 EMR 和索赔数据，调整后的 OAC 治疗率分别为 90% 和 63%。82%的房颤患者接受了控制心率的治疗，12%的患者接受了控制心律的治疗。不开具 OAC 处方的最常见原因是跌倒风险增加、痴呆和出血风险增加。结论我们的研究结果表明，心房颤动患者根据指南接受药物治疗的比例很高。粗略的 OAC 治疗率与调整后的 OAC 治疗率之间存在很大差异。这是由于个别禁忌症和合并症无法通过 ICD 编码记录下来。因此，基于EMR粗略数据或索赔数据的质量指标会导致对医疗质量的系统性低估。不能排除对低风险患者过度治疗的可能性。

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引用次数: 0

Refractory myasthenia gravis – clinical profile, comorbidities and response to rituximab 难治性重症肌无力-临床概况，合并症和对利妥昔单抗的反应

Q1 Medicine

GMS German Medical Science

Pub Date : 2016-10-13 DOI: 10.3205/000239

Sreenivasa Rao Sudulagunta, Mona Sepehrar, Mahesh Babu Sodalagunta, Aravinda Settikere Nataraju, Shiva Kumar Bangalore Raja, D. Sathyanarayana, Siddharth Gummadi, Hema Burra

Introduction: Myasthenia gravis (MG) is an antibody mediated autoimmune neuromuscular disorder characterized by fatigable muscle weakness. A proportion of myasthenia gravis patients are classified as refractory due to non responsiveness to conventional treatment. This retrospective study was done to evaluate clinical profile, epidemiological, laboratory, and features of patients with MG and mode of management using rituximab and complications. Methods: Data of myasthenia gravis patients admitted or presented to outpatient department (previous medical records) with MG between January 2008 and January 2016 were included. A total of 512 patients fulfilled the clinical and diagnostic criteria of myasthenia gravis of which 76 patients met the diagnostic certainty for refractory myasthenia gravis and were evaluated. Results: Out of 76 refractory MG patients, 53 (69.73%) patients fulfilled all the three defined criteria. The median age of onset of the refractory MG group was 36 years with a range of 27–53 years. In our study 25 patients (32.89%) belonged to the age group of 21–30 years. Anti-MuSK antibodies were positive in 8 non-refractory MG patients (2.06%) and 36 refractory MG patients (47.36%). Mean HbA1C was found to be 8.6±2.33. The dose of administered prednisone decreased by a mean of 59.7% (p=3.3x10–8) to 94.6% (p=2.2x10–14) after the third cycle of rituximab treatment. Conclusion: The refractory MG patients are most commonly female with an early age of onset, anti-MuSK antibodies, and thymomas. Refractory MG patients have higher prevalence and poor control (HbA1C >8%) of diabetes mellitus and dyslipidemia probably due to increased steroid usage. Rituximab is very efficient in treatment of refractory MG with adverse effects being low.

重症肌无力是一种以疲劳性肌肉无力为特征的抗体介导的自身免疫性神经肌肉疾病。一部分重症肌无力患者由于对常规治疗无反应而被归类为难治性。本回顾性研究旨在评估MG患者的临床概况、流行病学、实验室和特征，以及利妥昔单抗的治疗模式和并发症。方法:纳入2008年1月至2016年1月期间因MG入院或门诊就诊的重症肌无力患者(既往病历)的资料。512例患者符合重症肌无力的临床及诊断标准，其中76例患者符合难治性重症肌无力的诊断确定性并进行评价。结果:76例难治性MG患者中，53例(69.73%)患者满足所有三个定义标准。难治性MG组的中位发病年龄为36岁，范围为27-53岁。本组25例患者(32.89%)年龄在21 ~ 30岁。非难治性MG患者8例(2.06%)、难治性MG患者36例(47.36%)出现抗麝香抗体阳性。平均HbA1C为8.6±2.33。在利妥昔单抗治疗第三个周期后，泼尼松给药剂量平均减少59.7% (p= 3.3x10-8)至94.6% (p= 2.2x10-14)。结论:难治性MG患者多为女性，发病年龄早，有抗麝香抗体和胸腺瘤。难治性MG患者的糖尿病和血脂异常患病率较高，控制较差(HbA1C≤8%)，可能是由于类固醇使用增加所致。利妥昔单抗治疗难治性MG非常有效，不良反应低。

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引用次数: 32