呼吸有效性小组2015年冬季峰会的会议摘要-世界各地的数据库和登记处:最大限度地提高产量

IF 2.3 Q2 MEDICINE, GENERAL & INTERNAL Pragmatic and Observational Research Pub Date : 2015-04-23 DOI:10.2147/POR.S83049
A. Chisholm, Mylee Durack
{"title":"呼吸有效性小组2015年冬季峰会的会议摘要-世界各地的数据库和登记处:最大限度地提高产量","authors":"A. Chisholm, Mylee Durack","doi":"10.2147/POR.S83049","DOIUrl":null,"url":null,"abstract":": Current guidelines typically adopt a mechanistic approach to therapeutic management rather than a more individualized approach, guided by analysis of a patient’s problems. The result is that many patients end up on high levels of medications, possibly over-treated, yet uncontrolled. Guidelines currently recommend solutions based on the mean outcomes from registration trials. As such, they are probably applicable to only around 5% of the respiratory population that lies either side of that mean and not the majority of patients, eg, those with comorbidities and lifestyle complications. While the guidelines’ approach puts evidence at the center of their decision making, an evidence-based approach that will benefit the patient must put the patient at the center and adapt the available evidence to their specific needs. Examination of databases goes some way to seeing what happens in real-life and (to some degree) reflects this more patient-centric approach to evaluation of the evidence. By considering the interaction Abstract: In recent years we have developed different epidemiological studies with data obtained from the Information System for Development in Research in Primary Care, a population database that contains information of 5.8 million inhabitants (80% of Catalonia’s population). In one of them newly diagnosed COPD patients in the years 2007–2012 were identified through a diagnostic algorithm, and patients with a diagnostic spirometry were included and classified based on GOLD severity stages. Information about the initial treatment patterns was collected. No information regarding Modified Medical Research Council Dyspnea Scale (mMRC) or the COPD assessment test (CAT) was available but previous diagnosis of asthma and exacerbations during the previous year were collected. We identified 15,312 patients with newly diagnosed COPD. The frequency of patients with a previous diagnosis of asthma or frequent exacerbations was similar between groups (up to 6.6% of patients with previous asthma and 24.5% of frequent exacerbations). Regarding treatment, milder patients were more likely to receive short-acting bronchodilators in monotherapy (21% of patients in GOLD 1 versus 14.8% in GOLD 4) or no treatment after diagnosis (38.7% GOLD 1 versus 13.6% GOLD 4) while patients in GOLD 4 received triple therapy more frequently compared to GOLD 1 (36.6% versus 5.7%). Few patients were treated with double therapy (from 1.6% patients in GOLD 1 to 4% in GOLD 3). The percentage of patients treated with inhaled corticosteroid was higher in the severe groups (28.3%, 37.3%, 51.3%, 59.3% for GOLD 1 to 4 respectively). Other studies are ongoing on the prevalence of AAT determinations in primary care and the compliance with once daily and twice daily long-acting muscarinic antagonists in COPD in primary care. Background: The large-scale international implementing Helping Asthma in Real People (iHARP) project, which arose from the pilot project in Ireland in 2009, aims to improve the management of patients with moderate-to-severe asthma using validated assessment tools. The database that emanated from the iHARP project is described here. Methods: Five thousand adult patients with ( old) were recruited from the UK the Netherlands Spain (11%), and The patients had $ 2 prescriptions for fixed-dose combination inhaled corticosteroid/long-acting β - agonist therapy delivered via a dry powder inhaler or metered dose inhaler (with or without spacers) in Background: France has a publicly funded health insurance system, covering the whole population. The Système national d’information inter-régimes de l’Assurance maladie (SNIIRAM) records all claims of medical resource utilization from the national population, including the PMSI (Programme Médicalisé des Systèmes d’Information or Medicalized Program of Information System, ie, hospital activity and expenditure data). The EGB (échantillon général des bénéficiaires), a 1% random sample of the SNIIRAM, is also available for research projects. Aim: To describe claims data available in France for observational research, ie, SNIIRAM and EGB, and to provide examples of studies conducted with these resources. Methods: SNIIRAM and EGB will be described, with advantages and limitations. Access to these resources and organization of data management and analysis will be discussed. Finally, three projects will be briefly presented to illustrate the interest of using French claims data, more specifically in respiratory medicine/allergy: Results: SNIIRAM/EGB contain exhaustive data on medical resource utilization, with individual linkages between primary (eg, medical contacts and pharmacy refills) and secondary care. EGB (N . 500,000, data are by the of well-argued requests. In both datasets, diagnoses are missing, unless patients hospitalized or suffer from severe conditions; results from investigations (eg, blood sampling, radiology) are also missing. Hospital stays are recorded, with details of diagnoses (International Classification of Diseases-10 codes), procedures, diagnosis related group (DRG) codes, and admission/discharge dates. Dates of death are recorded. SNIIRAM can be linked to external medical records, eg, using a trusted third party procedure. RATIO identified a group of patients at higher risk of asthma exacerbations; APSI suggested an effect of immunotherapy in children; SINGULAIR concluded to the non-inferiority of montelukast compared to inhaled corticosteroids in infants. Conclusion: French reimbursement data provide high quality data on exposure to therapy, and occurrence of major outcomes in a large, longitudinal, population. Despite their limitations, they may be used to assess exhaustive individual Health Care Utilization, and to study drug use (including adherence), and positive or adverse effects of interventions in real-life setting. Abstract: The Canadian Primary Care Sentinel Surveillance Network or CPCSSN is a primary care research initiative – it is the first pan-Canadian multi-disease electronic medical record surveillance system using health information from electronic medical records in the offices of participating primary care family physicians across the country. This database is still in its relative infancy. Inconsistent data entry necessitates data cleaning. For respiratory disease, COPD is currently the only one with work having been accomplished. Multiple codes have been amalgamated into COPD including chronic bronchitis, emphysema, chronic airflow obstruction not otherwise defined and the use of tiotropium, ipratropium and salbutamol as long as a diagnosis of asthma was not made. Smoking status has also been a particularly trying process, with multiple potential codes causing confusion including non-smoker, ex-smoker, smoker trying to quit, smoking, nicotine addiction etc. We will discuss opportunities for its use both in Canada and hopefully within a future Respiratory Effectiveness Group initiative. Abstract: This abstract reports an interim analysis of a prospective observational cohort study designed to assess the rate, the patterns, and the drivers of adherence by COPD patients. We assessed adherence using medication belief questionnaires, pharmacy refill records, visual assessment of technique, and via an acoustic recording device attached to the inhaler (INCA TM ). To date we have enrolled 161 patients with COPD who have used the INCA TM adapted salmeterol/fluticasone inhaler for up to 3 months after discharge from hospital. The purpose of this study is to follow 400 patients for 90 days after an exacerbation to identify the relationship between adherence and the patient’s clinical course. The clinical characteristics of this cohort are noteworthy for the number of comorbidities (Charlson co-morbidity 5.8), the number of concurrent medications (mean 16), the presence of extreme hyperinflation, (cough peak expiratory flow rate 170), the level of health literacy (33), and the extremely high prevalence of mild cognitive impairment in this group (78%). These latter points suggest that a strategy to address adherence needs to be based on a framework used for patients with mild cognitive impairment. The calculated rate of adherence was 0.6 ± 0.3, and the calculated rate of inhaler errors was 0.35 ± 0.3 with combined actual rate of adherence 0.28 ± 0.3. In the first month after discharge, the rate of use was higher in those who did not have an exacerbation 32 ± 32 compared to those who did 19 ± 30. Hence, it is important to evaluate adherence as part of evaluating the clinical course of a patient with COPD. Four distinct patterns of Background: Poor inhaler technique has been identified as an important reason for sub-optimal asthma control. 1 To date, inhaler technique has only been studied in a small number of studies and only in patients receiving inhaled corticosteroid monotherapy. 2 to evaluate the prognostic role of inhaler technique and other patient- and treatment-related factors in asthma control in patients receiving fixed dose combination therapy (FDC) ± short-acting β 2 -agonist therapy. each two control: controlled/partly controlled versus Background: Errors in inhaler device handling are associated with having poor asthma control. Therefore, health care practitioners (HCP) are advised to assess and train patients in the use of their inhalers at every visit. It has been shown that demonstrating correct inhaler technique to patients helps them achieve and maintain correct inhaler technique. However, few HCP demonstrate correct inhaler technique as most are often not trained in the use of inhalers. Aim: This study aimed to examine the ease of device mastery for Turbuhaler ® (TH) versus Spiromax (SP) by trainee HCP, based on the hypothesis that SP is more intuitive. Methods: This randomized, cross-over group study comprises three visits over 2 months (Figure 1). Results of visit one are reported here. The study examined device mastery of inhaler technique i","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"6 1","pages":"13 - 38"},"PeriodicalIF":2.3000,"publicationDate":"2015-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S83049","citationCount":"2","resultStr":"{\"title\":\"Meeting abstracts from the Respiratory Effectiveness Group 2015 Winter Summit – databases and registries around the world: maximizing the yield\",\"authors\":\"A. 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Examination of databases goes some way to seeing what happens in real-life and (to some degree) reflects this more patient-centric approach to evaluation of the evidence. By considering the interaction Abstract: In recent years we have developed different epidemiological studies with data obtained from the Information System for Development in Research in Primary Care, a population database that contains information of 5.8 million inhabitants (80% of Catalonia’s population). In one of them newly diagnosed COPD patients in the years 2007–2012 were identified through a diagnostic algorithm, and patients with a diagnostic spirometry were included and classified based on GOLD severity stages. Information about the initial treatment patterns was collected. No information regarding Modified Medical Research Council Dyspnea Scale (mMRC) or the COPD assessment test (CAT) was available but previous diagnosis of asthma and exacerbations during the previous year were collected. We identified 15,312 patients with newly diagnosed COPD. The frequency of patients with a previous diagnosis of asthma or frequent exacerbations was similar between groups (up to 6.6% of patients with previous asthma and 24.5% of frequent exacerbations). Regarding treatment, milder patients were more likely to receive short-acting bronchodilators in monotherapy (21% of patients in GOLD 1 versus 14.8% in GOLD 4) or no treatment after diagnosis (38.7% GOLD 1 versus 13.6% GOLD 4) while patients in GOLD 4 received triple therapy more frequently compared to GOLD 1 (36.6% versus 5.7%). Few patients were treated with double therapy (from 1.6% patients in GOLD 1 to 4% in GOLD 3). The percentage of patients treated with inhaled corticosteroid was higher in the severe groups (28.3%, 37.3%, 51.3%, 59.3% for GOLD 1 to 4 respectively). Other studies are ongoing on the prevalence of AAT determinations in primary care and the compliance with once daily and twice daily long-acting muscarinic antagonists in COPD in primary care. Background: The large-scale international implementing Helping Asthma in Real People (iHARP) project, which arose from the pilot project in Ireland in 2009, aims to improve the management of patients with moderate-to-severe asthma using validated assessment tools. The database that emanated from the iHARP project is described here. Methods: Five thousand adult patients with ( old) were recruited from the UK the Netherlands Spain (11%), and The patients had $ 2 prescriptions for fixed-dose combination inhaled corticosteroid/long-acting β - agonist therapy delivered via a dry powder inhaler or metered dose inhaler (with or without spacers) in Background: France has a publicly funded health insurance system, covering the whole population. The Système national d’information inter-régimes de l’Assurance maladie (SNIIRAM) records all claims of medical resource utilization from the national population, including the PMSI (Programme Médicalisé des Systèmes d’Information or Medicalized Program of Information System, ie, hospital activity and expenditure data). The EGB (échantillon général des bénéficiaires), a 1% random sample of the SNIIRAM, is also available for research projects. Aim: To describe claims data available in France for observational research, ie, SNIIRAM and EGB, and to provide examples of studies conducted with these resources. Methods: SNIIRAM and EGB will be described, with advantages and limitations. Access to these resources and organization of data management and analysis will be discussed. Finally, three projects will be briefly presented to illustrate the interest of using French claims data, more specifically in respiratory medicine/allergy: Results: SNIIRAM/EGB contain exhaustive data on medical resource utilization, with individual linkages between primary (eg, medical contacts and pharmacy refills) and secondary care. EGB (N . 500,000, data are by the of well-argued requests. In both datasets, diagnoses are missing, unless patients hospitalized or suffer from severe conditions; results from investigations (eg, blood sampling, radiology) are also missing. Hospital stays are recorded, with details of diagnoses (International Classification of Diseases-10 codes), procedures, diagnosis related group (DRG) codes, and admission/discharge dates. Dates of death are recorded. SNIIRAM can be linked to external medical records, eg, using a trusted third party procedure. RATIO identified a group of patients at higher risk of asthma exacerbations; APSI suggested an effect of immunotherapy in children; SINGULAIR concluded to the non-inferiority of montelukast compared to inhaled corticosteroids in infants. Conclusion: French reimbursement data provide high quality data on exposure to therapy, and occurrence of major outcomes in a large, longitudinal, population. Despite their limitations, they may be used to assess exhaustive individual Health Care Utilization, and to study drug use (including adherence), and positive or adverse effects of interventions in real-life setting. Abstract: The Canadian Primary Care Sentinel Surveillance Network or CPCSSN is a primary care research initiative – it is the first pan-Canadian multi-disease electronic medical record surveillance system using health information from electronic medical records in the offices of participating primary care family physicians across the country. This database is still in its relative infancy. Inconsistent data entry necessitates data cleaning. For respiratory disease, COPD is currently the only one with work having been accomplished. Multiple codes have been amalgamated into COPD including chronic bronchitis, emphysema, chronic airflow obstruction not otherwise defined and the use of tiotropium, ipratropium and salbutamol as long as a diagnosis of asthma was not made. Smoking status has also been a particularly trying process, with multiple potential codes causing confusion including non-smoker, ex-smoker, smoker trying to quit, smoking, nicotine addiction etc. We will discuss opportunities for its use both in Canada and hopefully within a future Respiratory Effectiveness Group initiative. Abstract: This abstract reports an interim analysis of a prospective observational cohort study designed to assess the rate, the patterns, and the drivers of adherence by COPD patients. We assessed adherence using medication belief questionnaires, pharmacy refill records, visual assessment of technique, and via an acoustic recording device attached to the inhaler (INCA TM ). To date we have enrolled 161 patients with COPD who have used the INCA TM adapted salmeterol/fluticasone inhaler for up to 3 months after discharge from hospital. The purpose of this study is to follow 400 patients for 90 days after an exacerbation to identify the relationship between adherence and the patient’s clinical course. The clinical characteristics of this cohort are noteworthy for the number of comorbidities (Charlson co-morbidity 5.8), the number of concurrent medications (mean 16), the presence of extreme hyperinflation, (cough peak expiratory flow rate 170), the level of health literacy (33), and the extremely high prevalence of mild cognitive impairment in this group (78%). These latter points suggest that a strategy to address adherence needs to be based on a framework used for patients with mild cognitive impairment. The calculated rate of adherence was 0.6 ± 0.3, and the calculated rate of inhaler errors was 0.35 ± 0.3 with combined actual rate of adherence 0.28 ± 0.3. In the first month after discharge, the rate of use was higher in those who did not have an exacerbation 32 ± 32 compared to those who did 19 ± 30. Hence, it is important to evaluate adherence as part of evaluating the clinical course of a patient with COPD. Four distinct patterns of Background: Poor inhaler technique has been identified as an important reason for sub-optimal asthma control. 1 To date, inhaler technique has only been studied in a small number of studies and only in patients receiving inhaled corticosteroid monotherapy. 2 to evaluate the prognostic role of inhaler technique and other patient- and treatment-related factors in asthma control in patients receiving fixed dose combination therapy (FDC) ± short-acting β 2 -agonist therapy. each two control: controlled/partly controlled versus Background: Errors in inhaler device handling are associated with having poor asthma control. Therefore, health care practitioners (HCP) are advised to assess and train patients in the use of their inhalers at every visit. It has been shown that demonstrating correct inhaler technique to patients helps them achieve and maintain correct inhaler technique. However, few HCP demonstrate correct inhaler technique as most are often not trained in the use of inhalers. Aim: This study aimed to examine the ease of device mastery for Turbuhaler ® (TH) versus Spiromax (SP) by trainee HCP, based on the hypothesis that SP is more intuitive. Methods: This randomized, cross-over group study comprises three visits over 2 months (Figure 1). Results of visit one are reported here. 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引用次数: 2

摘要

当前的指南通常采用机械的方法进行治疗管理,而不是更个性化的方法,以分析患者的问题为指导。其结果是,许多患者最终服用了大量药物,可能是过度治疗,但却得不到控制。指南目前推荐的解决方案是基于注册试验的平均结果。因此,它们可能只适用于位于平均值两侧的约5%的呼吸系统人群,而不是大多数患者,例如,那些有合并症和生活方式并发症的患者。虽然指南的方法将证据置于决策的中心,但有利于患者的循证方法必须将患者置于中心,并根据患者的具体需求调整现有证据。对数据库的检查在某种程度上可以看到现实生活中发生了什么,并且(在某种程度上)反映了这种以患者为中心的证据评估方法。摘要:近年来,我们利用从初级保健研究发展信息系统获得的数据开展了不同的流行病学研究,这是一个包含580万居民(占加泰罗尼亚人口的80%)信息的人口数据库。其中一组通过诊断算法识别2007-2012年新诊断的COPD患者,并纳入诊断性肺活量测定的患者,并根据GOLD严重程度分期进行分类。收集了有关初始治疗模式的信息。没有关于修改医学研究委员会呼吸困难量表(mMRC)或COPD评估试验(CAT)的信息,但收集了前一年的哮喘和急性发作的既往诊断。我们确定了15312例新诊断的COPD患者。既往诊断为哮喘或频繁发作的患者的频率在两组之间相似(高达6.6%的既往哮喘患者和24.5%的频繁发作)。在治疗方面,轻度患者更有可能在单药治疗中接受短效支气管扩张剂(GOLD 1组中21%的患者对GOLD 4组中14.8%的患者)或在诊断后不接受治疗(GOLD 1组中38.7%对13.6%),而GOLD 4组中接受三联治疗的患者比GOLD 1组更频繁(36.6%对5.7%)。很少有患者接受双重治疗(GOLD 1组为1.6%,GOLD 3组为4%)。重症组吸入皮质类固醇治疗的患者比例更高(GOLD 1至4组分别为28.3%,37.3%,51.3%,59.3%)。其他关于初级保健中AAT测定的流行程度以及慢性阻塞性肺病初级保健中每日1次和每日2次长效毒蕈碱拮抗剂的依从性的研究正在进行中。背景:2009年爱尔兰的试点项目引发了大规模的国际实施帮助哮喘患者(iHARP)项目,旨在使用经过验证的评估工具改善中重度哮喘患者的管理。这里描述了来自iHARP项目的数据库。方法:从英国、荷兰、西班牙(11%)招募5000名成年(老年)患者,患者使用2美元的处方,通过干粉吸入器或计量吸入器(带或不带间隔物)给予固定剂量吸入皮质类固醇/长效β激动剂联合治疗。国家医疗信息系统(SNIIRAM)记录了全国人口关于医疗资源利用的所有索赔,包括医疗信息系统(PMSI)方案(医疗信息系统方案),即医院活动和支出数据。EGB(从SNIIRAM中随机抽取1%的样本)也可用于研究项目。目的:描述法国用于观察性研究的索赔数据,即SNIIRAM和EGB,并提供使用这些资源进行的研究示例。方法:介绍SNIIRAM和EGB的优缺点。访问这些资源和组织数据管理和分析将被讨论。最后,将简要介绍三个项目,以说明使用法国索赔数据的兴趣,更具体地说,在呼吸系统医学/过敏方面:结果:SNIIRAM/EGB包含关于医疗资源利用的详尽数据,以及初级(例如,医疗接触和药房补充)和二级保健之间的个别联系。鸡蛋(名词)50万,数据是经过充分论证的请求。在这两个数据集中,诊断都缺失,除非患者住院或患有严重疾病;调查结果(如血液采样、放射学)也缺失。 当前的指南通常采用机械的方法进行治疗管理,而不是更个性化的方法,以分析患者的问题为指导。其结果是,许多患者最终服用了大量药物,可能是过度治疗,但却得不到控制。指南目前推荐的解决方案是基于注册试验的平均结果。因此,它们可能只适用于位于平均值两侧的约5%的呼吸系统人群,而不是大多数患者,例如,那些有合并症和生活方式并发症的患者。虽然指南的方法将证据置于决策的中心,但有利于患者的循证方法必须将患者置于中心,并根据患者的具体需求调整现有证据。对数据库的检查在某种程度上可以看到现实生活中发生了什么,并且(在某种程度上)反映了这种以患者为中心的证据评估方法。摘要:近年来,我们利用从初级保健研究发展信息系统获得的数据开展了不同的流行病学研究,这是一个包含580万居民(占加泰罗尼亚人口的80%)信息的人口数据库。其中一组通过诊断算法识别2007-2012年新诊断的COPD患者,并纳入诊断性肺活量测定的患者,并根据GOLD严重程度分期进行分类。收集了有关初始治疗模式的信息。没有关于修改医学研究委员会呼吸困难量表(mMRC)或COPD评估试验(CAT)的信息,但收集了前一年的哮喘和急性发作的既往诊断。我们确定了15312例新诊断的COPD患者。既往诊断为哮喘或频繁发作的患者的频率在两组之间相似(高达6.6%的既往哮喘患者和24.5%的频繁发作)。在治疗方面,轻度患者更有可能在单药治疗中接受短效支气管扩张剂(GOLD 1组中21%的患者对GOLD 4组中14.8%的患者)或在诊断后不接受治疗(GOLD 1组中38.7%对13.6%),而GOLD 4组中接受三联治疗的患者比GOLD 1组更频繁(36.6%对5.7%)。很少有患者接受双重治疗(GOLD 1组为1.6%,GOLD 3组为4%)。重症组吸入皮质类固醇治疗的患者比例更高(GOLD 1至4组分别为28.3%,37.3%,51.3%,59.3%)。其他关于初级保健中AAT测定的流行程度以及慢性阻塞性肺病初级保健中每日1次和每日2次长效毒蕈碱拮抗剂的依从性的研究正在进行中。背景:2009年爱尔兰的试点项目引发了大规模的国际实施帮助哮喘患者(iHARP)项目,旨在使用经过验证的评估工具改善中重度哮喘患者的管理。这里描述了来自iHARP项目的数据库。方法:从英国、荷兰、西班牙(11%)招募5000名成年(老年)患者,患者使用2美元的处方,通过干粉吸入器或计量吸入器(带或不带间隔物)给予固定剂量吸入皮质类固醇/长效β激动剂联合治疗。国家医疗信息系统(SNIIRAM)记录了全国人口关于医疗资源利用的所有索赔,包括医疗信息系统(PMSI)方案(医疗信息系统方案),即医院活动和支出数据。EGB(从SNIIRAM中随机抽取1%的样本)也可用于研究项目。目的:描述法国用于观察性研究的索赔数据,即SNIIRAM和EGB,并提供使用这些资源进行的研究示例。方法:介绍SNIIRAM和EGB的优缺点。访问这些资源和组织数据管理和分析将被讨论。最后,将简要介绍三个项目,以说明使用法国索赔数据的兴趣,更具体地说,在呼吸系统医学/过敏方面:结果:SNIIRAM/EGB包含关于医疗资源利用的详尽数据,以及初级(例如,医疗接触和药房补充)和二级保健之间的个别联系。鸡蛋(名词)50万,数据是经过充分论证的请求。在这两个数据集中,诊断都缺失,除非患者住院或患有严重疾病;调查结果(如血液采样、放射学)也缺失。 记录住院时间,详细记录诊断(国际疾病分类-10代码)、程序、诊断相关组(DRG)代码和入院/出院日期。死亡日期被记录下来SNIIRAM可以链接到外部医疗记录,例如,使用可信的第三方程序。RATIO确定了一组哮喘发作风险较高的患者;APSI提示儿童免疫治疗的效果;SINGULAIR认为孟鲁司特与婴儿吸入皮质类固醇相比无劣效性。结论:法国的报销数据提供了高质量的治疗暴露数据,以及在大型纵向人群中发生的主要结果。尽管有其局限性,但它们可用于评估详尽的个人卫生保健利用情况,并研究药物使用(包括依从性),以及在现实生活中干预措施的积极或不利影响。摘要:加拿大初级保健哨点监测网络(cpcsn)是一项初级保健研究计划,它是第一个泛加拿大多疾病电子病历监测系统,使用全国参与初级保健家庭医生办公室电子病历中的健康信息。这个数据库还处于相对初级阶段。不一致的数据输入需要数据清理。对于呼吸系统疾病,COPD是目前唯一已经完成工作的疾病。慢性阻塞性肺病包括慢性支气管炎、肺气肿、慢性气流阻塞,但没有其他定义,只要没有哮喘诊断,就可以使用噻托溴铵、异丙托溴铵和沙丁胺醇。吸烟状态也是一个特别艰难的过程,有多种潜在的代码引起混淆,包括不吸烟者,前吸烟者,吸烟者试图戒烟,吸烟,尼古丁成瘾等。我们将讨论在加拿大使用它的机会,并希望在未来的呼吸效能组倡议。摘要:本摘要报告了一项前瞻性观察队列研究的中期分析,该研究旨在评估COPD患者的依从性、模式和驱动因素。我们使用药物信念问卷、药房补充记录、技术视觉评估以及附着在吸入器上的录音设备(INCA TM)来评估依从性。迄今为止,我们已经招募了161名COPD患者,他们在出院后使用了适合INCA TM的沙美特罗/氟替卡松吸入器长达3个月。本研究的目的是在病情加重后对400名患者进行90天的随访,以确定依从性与患者临床病程之间的关系。该队列的临床特征值得注意的是合并症的数量(Charlson合并症5.8例),同时使用药物的数量(平均16例),极度极度膨胀的存在(咳嗽呼气流量峰值170例),健康知识水平(33例),以及该组中极高的轻度认知障碍患病率(78%)。后一点表明,解决依从性的策略需要基于轻度认知障碍患者使用的框架。计算依从率为0.6±0.3,计算吸入器错误率为0.35±0.3,综合实际依从率为0.28±0.3。在出院后的第一个月,没有加重的患者(32±32)的使用率高于加重的患者(19±30)。因此,将依从性作为COPD患者临床病程评估的一部分是很重要的。背景:不良的吸入器技术已被确定为哮喘控制不理想的重要原因。迄今为止,吸入器技术仅在少数研究中进行了研究,并且仅在接受吸入皮质类固醇单一治疗的患者中进行了研究。评估吸入器技术和其他患者及治疗相关因素在接受固定剂量联合治疗(FDC)±短效β 2激动剂治疗的患者哮喘控制中的预后作用。背景:吸入器处理错误与哮喘控制不良有关。因此,建议卫生保健从业人员(HCP)在每次就诊时评估和培训患者使用吸入器。研究表明,向患者展示正确的吸入器技术有助于他们实现并保持正确的吸入器技术。然而,很少有HCP表现出正确的吸入器技术,因为大多数人往往没有接受过使用吸入器的培训。目的:本研究旨在基于SP更直观的假设,检验受训HCP对Turbuhaler®(TH)与Spiromax (SP)的设备掌握程度。方法:这项随机、交叉组研究包括2个月内的三次就诊(图1)。第一次就诊的结果在这里报告。 记录住院时间,详细记录诊断(国际疾病分类-10代码)、程序、诊断相关组(DRG)代码和入院/出院日期。死亡日期被记录下来SNIIRAM可以链接到外部医疗记录,例如,使用可信的第三方程序。RATIO确定了一组哮喘发作风险较高的患者;APSI提示儿童免疫治疗的效果;SINGULAIR认为孟鲁司特与婴儿吸入皮质类固醇相比无劣效性。结论:法国的报销数据提供了高质量的治疗暴露数据,以及在大型纵向人群中发生的主要结果。尽管有其局限性,但它们可用于评估详尽的个人卫生保健利用情况,并研究药物使用(包括依从性),以及在现实生活中干预措施的积极或不利影响。摘要:加拿大初级保健哨点监测网络(cpcsn)是一项初级保健研究计划,它是第一个泛加拿大多疾病电子病历监测系统,使用全国参与初级保健家庭医生办公室电子病历中的健康信息。这个数据库还处于相对初级阶段。不一致的数据输入需要数据清理。对于呼吸系统疾病,COPD是目前唯一已经完成工作的疾病。慢性阻塞性肺病包括慢性支气管炎、肺气肿、慢性气流阻塞,但没有其他定义,只要没有哮喘诊断,就可以使用噻托溴铵、异丙托溴铵和沙丁胺醇。吸烟状态也是一个特别艰难的过程,有多种潜在的代码引起混淆,包括不吸烟者,前吸烟者,吸烟者试图戒烟,吸烟,尼古丁成瘾等。我们将讨论在加拿大使用它的机会,并希望在未来的呼吸效能组倡议。摘要:本摘要报告了一项前瞻性观察队列研究的中期分析,该研究旨在评估COPD患者的依从性、模式和驱动因素。我们使用药物信念问卷、药房补充记录、技术视觉评估以及附着在吸入器上的录音设备(INCA TM)来评估依从性。迄今为止,我们已经招募了161名COPD患者,他们在出院后使用了适合INCA TM的沙美特罗/氟替卡松吸入器长达3个月。本研究的目的是在病情加重后对400名患者进行90天的随访,以确定依从性与患者临床病程之间的关系。该队列的临床特征值得注意的是合并症的数量(Charlson合并症5.8例),同时使用药物的数量(平均16例),极度极度膨胀的存在(咳嗽呼气流量峰值170例),健康知识水平(33例),以及该组中极高的轻度认知障碍患病率(78%)。后一点表明,解决依从性的策略需要基于轻度认知障碍患者使用的框架。计算依从率为0.6±0.3,计算吸入器错误率为0.35±0.3,综合实际依从率为0.28±0.3。在出院后的第一个月,没有加重的患者(32±32)的使用率高于加重的患者(19±30)。因此,将依从性作为COPD患者临床病程评估的一部分是很重要的。背景:不良的吸入器技术已被确定为哮喘控制不理想的重要原因。迄今为止,吸入器技术仅在少数研究中进行了研究,并且仅在接受吸入皮质类固醇单一治疗的患者中进行了研究。评估吸入器技术和其他患者及治疗相关因素在接受固定剂量联合治疗(FDC)±短效β 2激动剂治疗的患者哮喘控制中的预后作用。背景:吸入器处理错误与哮喘控制不良有关。因此,建议卫生保健从业人员(HCP)在每次就诊时评估和培训患者使用吸入器。研究表明,向患者展示正确的吸入器技术有助于他们实现并保持正确的吸入器技术。然而,很少有HCP表现出正确的吸入器技术,因为大多数人往往没有接受过使用吸入器的培训。目的:本研究旨在基于SP更直观的假设,检验受训HCP对Turbuhaler®(TH)与Spiromax (SP)的设备掌握程度。方法:这项随机、交叉组研究包括2个月内的三次就诊(图1)。第一次就诊的结果在这里报告。 本研究考察了吸入器技术的设备掌握情况 本研究考察了吸入器技术的设备掌握情况
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Meeting abstracts from the Respiratory Effectiveness Group 2015 Winter Summit – databases and registries around the world: maximizing the yield
: Current guidelines typically adopt a mechanistic approach to therapeutic management rather than a more individualized approach, guided by analysis of a patient’s problems. The result is that many patients end up on high levels of medications, possibly over-treated, yet uncontrolled. Guidelines currently recommend solutions based on the mean outcomes from registration trials. As such, they are probably applicable to only around 5% of the respiratory population that lies either side of that mean and not the majority of patients, eg, those with comorbidities and lifestyle complications. While the guidelines’ approach puts evidence at the center of their decision making, an evidence-based approach that will benefit the patient must put the patient at the center and adapt the available evidence to their specific needs. Examination of databases goes some way to seeing what happens in real-life and (to some degree) reflects this more patient-centric approach to evaluation of the evidence. By considering the interaction Abstract: In recent years we have developed different epidemiological studies with data obtained from the Information System for Development in Research in Primary Care, a population database that contains information of 5.8 million inhabitants (80% of Catalonia’s population). In one of them newly diagnosed COPD patients in the years 2007–2012 were identified through a diagnostic algorithm, and patients with a diagnostic spirometry were included and classified based on GOLD severity stages. Information about the initial treatment patterns was collected. No information regarding Modified Medical Research Council Dyspnea Scale (mMRC) or the COPD assessment test (CAT) was available but previous diagnosis of asthma and exacerbations during the previous year were collected. We identified 15,312 patients with newly diagnosed COPD. The frequency of patients with a previous diagnosis of asthma or frequent exacerbations was similar between groups (up to 6.6% of patients with previous asthma and 24.5% of frequent exacerbations). Regarding treatment, milder patients were more likely to receive short-acting bronchodilators in monotherapy (21% of patients in GOLD 1 versus 14.8% in GOLD 4) or no treatment after diagnosis (38.7% GOLD 1 versus 13.6% GOLD 4) while patients in GOLD 4 received triple therapy more frequently compared to GOLD 1 (36.6% versus 5.7%). Few patients were treated with double therapy (from 1.6% patients in GOLD 1 to 4% in GOLD 3). The percentage of patients treated with inhaled corticosteroid was higher in the severe groups (28.3%, 37.3%, 51.3%, 59.3% for GOLD 1 to 4 respectively). Other studies are ongoing on the prevalence of AAT determinations in primary care and the compliance with once daily and twice daily long-acting muscarinic antagonists in COPD in primary care. Background: The large-scale international implementing Helping Asthma in Real People (iHARP) project, which arose from the pilot project in Ireland in 2009, aims to improve the management of patients with moderate-to-severe asthma using validated assessment tools. The database that emanated from the iHARP project is described here. Methods: Five thousand adult patients with ( old) were recruited from the UK the Netherlands Spain (11%), and The patients had $ 2 prescriptions for fixed-dose combination inhaled corticosteroid/long-acting β - agonist therapy delivered via a dry powder inhaler or metered dose inhaler (with or without spacers) in Background: France has a publicly funded health insurance system, covering the whole population. The Système national d’information inter-régimes de l’Assurance maladie (SNIIRAM) records all claims of medical resource utilization from the national population, including the PMSI (Programme Médicalisé des Systèmes d’Information or Medicalized Program of Information System, ie, hospital activity and expenditure data). The EGB (échantillon général des bénéficiaires), a 1% random sample of the SNIIRAM, is also available for research projects. Aim: To describe claims data available in France for observational research, ie, SNIIRAM and EGB, and to provide examples of studies conducted with these resources. Methods: SNIIRAM and EGB will be described, with advantages and limitations. Access to these resources and organization of data management and analysis will be discussed. Finally, three projects will be briefly presented to illustrate the interest of using French claims data, more specifically in respiratory medicine/allergy: Results: SNIIRAM/EGB contain exhaustive data on medical resource utilization, with individual linkages between primary (eg, medical contacts and pharmacy refills) and secondary care. EGB (N . 500,000, data are by the of well-argued requests. In both datasets, diagnoses are missing, unless patients hospitalized or suffer from severe conditions; results from investigations (eg, blood sampling, radiology) are also missing. Hospital stays are recorded, with details of diagnoses (International Classification of Diseases-10 codes), procedures, diagnosis related group (DRG) codes, and admission/discharge dates. Dates of death are recorded. SNIIRAM can be linked to external medical records, eg, using a trusted third party procedure. RATIO identified a group of patients at higher risk of asthma exacerbations; APSI suggested an effect of immunotherapy in children; SINGULAIR concluded to the non-inferiority of montelukast compared to inhaled corticosteroids in infants. Conclusion: French reimbursement data provide high quality data on exposure to therapy, and occurrence of major outcomes in a large, longitudinal, population. Despite their limitations, they may be used to assess exhaustive individual Health Care Utilization, and to study drug use (including adherence), and positive or adverse effects of interventions in real-life setting. Abstract: The Canadian Primary Care Sentinel Surveillance Network or CPCSSN is a primary care research initiative – it is the first pan-Canadian multi-disease electronic medical record surveillance system using health information from electronic medical records in the offices of participating primary care family physicians across the country. This database is still in its relative infancy. Inconsistent data entry necessitates data cleaning. For respiratory disease, COPD is currently the only one with work having been accomplished. Multiple codes have been amalgamated into COPD including chronic bronchitis, emphysema, chronic airflow obstruction not otherwise defined and the use of tiotropium, ipratropium and salbutamol as long as a diagnosis of asthma was not made. Smoking status has also been a particularly trying process, with multiple potential codes causing confusion including non-smoker, ex-smoker, smoker trying to quit, smoking, nicotine addiction etc. We will discuss opportunities for its use both in Canada and hopefully within a future Respiratory Effectiveness Group initiative. Abstract: This abstract reports an interim analysis of a prospective observational cohort study designed to assess the rate, the patterns, and the drivers of adherence by COPD patients. We assessed adherence using medication belief questionnaires, pharmacy refill records, visual assessment of technique, and via an acoustic recording device attached to the inhaler (INCA TM ). To date we have enrolled 161 patients with COPD who have used the INCA TM adapted salmeterol/fluticasone inhaler for up to 3 months after discharge from hospital. The purpose of this study is to follow 400 patients for 90 days after an exacerbation to identify the relationship between adherence and the patient’s clinical course. The clinical characteristics of this cohort are noteworthy for the number of comorbidities (Charlson co-morbidity 5.8), the number of concurrent medications (mean 16), the presence of extreme hyperinflation, (cough peak expiratory flow rate 170), the level of health literacy (33), and the extremely high prevalence of mild cognitive impairment in this group (78%). These latter points suggest that a strategy to address adherence needs to be based on a framework used for patients with mild cognitive impairment. The calculated rate of adherence was 0.6 ± 0.3, and the calculated rate of inhaler errors was 0.35 ± 0.3 with combined actual rate of adherence 0.28 ± 0.3. In the first month after discharge, the rate of use was higher in those who did not have an exacerbation 32 ± 32 compared to those who did 19 ± 30. Hence, it is important to evaluate adherence as part of evaluating the clinical course of a patient with COPD. Four distinct patterns of Background: Poor inhaler technique has been identified as an important reason for sub-optimal asthma control. 1 To date, inhaler technique has only been studied in a small number of studies and only in patients receiving inhaled corticosteroid monotherapy. 2 to evaluate the prognostic role of inhaler technique and other patient- and treatment-related factors in asthma control in patients receiving fixed dose combination therapy (FDC) ± short-acting β 2 -agonist therapy. each two control: controlled/partly controlled versus Background: Errors in inhaler device handling are associated with having poor asthma control. Therefore, health care practitioners (HCP) are advised to assess and train patients in the use of their inhalers at every visit. It has been shown that demonstrating correct inhaler technique to patients helps them achieve and maintain correct inhaler technique. However, few HCP demonstrate correct inhaler technique as most are often not trained in the use of inhalers. Aim: This study aimed to examine the ease of device mastery for Turbuhaler ® (TH) versus Spiromax (SP) by trainee HCP, based on the hypothesis that SP is more intuitive. Methods: This randomized, cross-over group study comprises three visits over 2 months (Figure 1). Results of visit one are reported here. The study examined device mastery of inhaler technique i
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Pragmatic and Observational Research
Pragmatic and Observational Research MEDICINE, GENERAL & INTERNAL-
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期刊介绍: Pragmatic and Observational Research is an international, peer-reviewed, open-access journal that publishes data from studies designed to closely reflect medical interventions in real-world clinical practice, providing insights beyond classical randomized controlled trials (RCTs). While RCTs maximize internal validity for cause-and-effect relationships, they often represent only specific patient groups. This journal aims to complement such studies by providing data that better mirrors real-world patients and the usage of medicines, thus informing guidelines and enhancing the applicability of research findings across diverse patient populations encountered in everyday clinical practice.
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