McCurdy B R
Ont Health Technol Assess Ser. 2012;12(10):1-65. Epub 2012 Mar 1.
In July 2010, the Medical Advisory Secretariat (MAS) began work on a Chronic Obstructive Pulmonary Disease (COPD) evidentiary framework, an evidence-based review of the literature surrounding treatment strategies for patients with COPD. This project emerged from a request by the Health System Strategy Division of the Ministry of Health and Long-Term Care that MAS provide them with an evidentiary platform on the effectiveness and cost-effectiveness of COPD interventions. After an initial review of health technology assessments and systematic reviews of COPD literature, and consultation with experts, MAS identified the following topics for analysis: vaccinations (influenza and pneumococcal), smoking cessation, multidisciplinary care, pulmonary rehabilitation, long-term oxygen therapy, noninvasive positive pressure ventilation for acute and chronic respiratory failure, hospital-at-home for acute exacerbations of COPD, and telehealth (including telemonitoring and telephone support). Evidence-based analyses were prepared for each of these topics. For each technology, an economic analysis was also completed where appropriate. In addition, a review of the qualitative literature on patient, caregiver, and provider perspectives on living and dying with COPD was conducted, as were reviews of the qualitative literature on each of the technologies included in these analyses. The Chronic Obstructive Pulmonary Disease Mega-Analysis series is made up of the following reports, which can be publicly accessed at the MAS website at: http://www.hqontario.ca/en/mas/mas_ohtas_mn.html. Chronic Obstructive Pulmonary Disease (COPD) Evidentiary Framework. Influenza and Pneumococcal Vaccinations for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis. Smoking Cessation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis. Community-Based Multidisciplinary Care for Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis. Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis. Long-term Oxygen Therapy for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis. Noninvasive Positive Pressure Ventilation for Acute Respiratory Failure Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis. Noninvasive Positive Pressure Ventilation for Chronic Respiratory Failure Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis. Hospital-at-Home Programs for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis. Home Telehealth for Patients with Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis. Cost-Effectiveness of Interventions for Chronic Obstructive Pulmonary Disease Using an Ontario Policy Model. Experiences of Living and Dying With COPD: A Systematic Review and Synthesis of the Qualitative Empirical Literature. For more information on the qualitative review, please contact Mita Giacomini at: http://fhs.mcmaster.ca/ceb/faculty_member_giacomini.htm. For more information on the economic analysis, please visit the PATH website: http://www.path-hta.ca/About-Us/Contact-Us.aspx. The Toronto Health Economics and Technology Assessment (THETA) collaborative has produced an associated report on patient preference for mechanical ventilation. For more information, please visit the THETA website: http://theta.utoronto.ca/static/contact. OBJECTIVE: The objective of this analysis was to compare hospital-at-home care with inpatient hospital care for patients with acute exacerbations of chronic obstructive pulmonary disease (COPD) who present to the emergency department (ED). CLINICAL NEED: CONDITION AND TARGET POPULATION: ACUTE EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE: Chronic obstructive pulmonary disease is a disease state characterized by airflow limitation that is not fully reversible. This airflow limitation is usually both progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases. The natural history of COPD involves periods of acute-onset worsening of symptoms, particularly increased breathlessness, cough, and/or sputum, that go beyond normal day-to-day variations; these are known as acute exacerbations. Two-thirds of COPD exacerbations are caused by an infection of the tracheobronchial tree or by air pollution; the cause in the remaining cases is unknown. On average, patients with moderate to severe COPD experience 2 or 3 exacerbations each year. Exacerbations have an important impact on patients and on the health care system. For the patient, exacerbations result in decreased quality of life, potentially permanent losses of lung function, and an increased risk of mortality. For the health care system, exacerbations of COPD are a leading cause of ED visits and hospitalizations, particularly in winter. TECHNOLOGY: Hospital-at-home programs offer an alternative for patients who present to the ED with an exacerbation of COPD and require hospital admission for their treatment. Hospital-at-home programs provide patients with visits in their home by medical professionals (typically specialist nurses) who monitor the patients, alter patients’ treatment plans if needed, and in some programs, provide additional care such as pulmonary rehabilitation, patient and caregiver education, and smoking cessation counselling. There are 2 types of hospital-at-home programs: admission avoidance and early discharge hospital-at-home. In the former, admission avoidance hospital-at-home, after patients are assessed in the ED, they are prescribed the necessary medications and additional care needed (e.g., oxygen therapy) and then sent home where they receive regular visits from a medical professional. In early discharge hospital-at-home, after being assessed in the ED, patients are admitted to the hospital where they receive the initial phase of their treatment. These patients are discharged into a hospital-at-home program before the exacerbation has resolved. In both cases, once the exacerbation has resolved, the patient is discharged from the hospital-at-home program and no longer receives visits in his/her home. In the models that exist to date, hospital-at-home programs differ from other home care programs because they deal with higher acuity patients who require higher acuity care, and because hospitals retain the medical and legal responsibility for patients. Furthermore, patients requiring home care services may require such services for long periods of time or indefinitely, whereas patients in hospital-at-home programs require and receive the services for a short period of time only. Hospital-at-home care is not appropriate for all patients with acute exacerbations of COPD. Ineligible patients include: those with mild exacerbations that can be managed without admission to hospital; those who require admission to hospital; and those who cannot be safely treated in a hospital-at-home program either for medical reasons and/or because of a lack of, or poor, social support at home. The proposed possible benefits of hospital-at-home for treatment of exacerbations of COPD include: decreased utilization of health care resources by avoiding hospital admission and/or reducing length of stay in hospital; decreased costs; increased health-related quality of life for patients and caregivers when treated at home; and reduced risk of hospital-acquired infections in this susceptible patient population. ONTARIO CONTEXT: No hospital-at-home programs for the treatment of acute exacerbations of COPD were identified in Ontario. Patients requiring acute care for their exacerbations are treated in hospitals. RESEARCH QUESTION: What is the effectiveness, cost-effectiveness, and safety of hospital-at-home care compared with inpatient hospital care of acute exacerbations of COPD? RESEARCH METHODS: LITERATURE SEARCH: SEARCH STRATEGY: A literature search was performed on August 5, 2010, using OVID MEDLINE, OVID MEDLINE In-Process and Other Non-Indexed Citations, OVID EMBASE, EBSCO Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Wiley Cochrane Library, and the Centre for Reviews and Dissemination database for studies published from January 1, 1990, to August 5, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists and health technology assessment websites were also examined for any additional relevant studies not identified through the systematic search. INCLUSION CRITERIA: English language full-text reports; health technology assessments, systematic reviews, meta-analyses, and randomized controlled trials (RCTs); studies performed exclusively in patients with a diagnosis of COPD or studies including patients with COPD as well as patients with other conditions, if results are reported for COPD patients separately; studies performed in patients with acute exacerbations of COPD who present to the ED; studies published between January 1, 1990, and August 5, 2010; studies comparing hospital-at-home and inpatient hospital care for patients with acute exacerbations of COPD; studies that include at least 1 of the outcomes of interest (listed below). Cochrane Collaboration reviews have defined hospital-at-home programs as those that provide patients with active treatment for their acute exacerbation in their home by medical professionals for a limited period of time (in this case, until the resolution of the exacerbation). If a hospital-at-home program had not been available, these patients would have been admitted to hospital for their treatment. EXCLUSION CRITERIA: < 18 years of age; animal studies; duplicate publications; grey literature. OUTCOMES OF INTEREST: PATIENT/CLINICAL OUTCOMES: mortality; lung function (forced expiratory volume in 1 second); health-related quality of life; patient or caregiver preference; patient or caregiver satisfaction with care; complications. HEALTH SYSTEM OUTCOMES: hospital readmissions; length of stay in hospital and hospital-at-home. ED visits; transfer to long-term care; days to readmission; eligibility for hospital-at-home. STATISTICAL METHODS: When possible, results were pooled using Review Manager 5 Version 5.1; otherwise, results were summarized descriptively. Data from RCTs were analyzed using intention-to-treat protocols. In addition, a sensitivity analysis was done assigning all missing data/withdrawals to the event. values less than 0.05 were considered significant. A priori subgroup analyses were planned for the acuity of hospital-at-home program, type of hospital-at-home program (early discharge or admission avoidance), and severity of the patients’ COPD. Additional subgroup analyses were conducted as needed based on the identified literature. Post hoc sample size calculations were performed using STATA 10.1. QUALITY OF EVIDENCE: The quality of each included study was assessed, taking into consideration allocation concealment, randomization, blinding, power/sample size, withdrawals/dropouts, and intention-to-treat analyses. The quality of the body of evidence was assessed as high, moderate, low, or very low according to the GRADE Working Group criteria. The following definitions of quality were used in grading the quality of the evidence: [Table: see text] SUMMARY OF FINDINGS: Fourteen studies met the inclusion criteria and were included in this review: 1 health technology assessment, 5 systematic reviews, and 7 RCTs. The following conclusions are based on low to very low quality of evidence. The reviewed evidence was based on RCTs that were inadequately powered to observe differences between hospital-at-home and inpatient hospital care for most outcomes, so there is a strong possibility of type II error. Given the low to very low quality of evidence, these conclusions must be considered with caution. Approximately 21% to 37% of patients with acute exacerbations of COPD who present to the ED may be eligible for hospital-at-home care. Of the patients who are eligible for care, some may refuse to participate in hospital-at-home care. Eligibility for hospital-at-home care may be increased depending on the design of the hospital-at-home program, such as the size of the geographical service area for hospital-at-home and the hours of operation for patient assessment and entry into hospital-at-home. Hospital-at-home care for acute exacerbations of COPD was associated with a nonsignificant reduction in the risk of mortality and hospital readmissions compared with inpatient hospital care during 2- to 6-month follow-up. Limited, very low quality evidence suggests that hospital readmissions are delayed in patients who received hospital-at-home care compared with those who received inpatient hospital care (mean additional days before readmission comparing hospital-at-home to inpatient hospital care ranged from 4 to 38 days). There is insufficient evidence to determine whether hospital-at-home care, compared with inpatient hospital care, is associated with improved lung function. The majority of studies did not find significant differences between hospital-at-home and inpatient hospital care for a variety of health-related quality of life measures at follow-up. However, follow-up may have been too late to observe an impact of hospital-at-home care on quality of life. A conclusion about the impact of hospital-at-home care on length of stay for the initial exacerbation (defined as days in hospital or days in hospital plus hospital-at-home care for inpatient hospital and hospital-at-home, respectively) could not be determined because of limited and inconsistent evidence. Patient and caregiver satisfaction with care is high for both hospital-at-home and inpatient hospital care.
2010年7月,医疗咨询秘书处(MAS)开始着手慢性阻塞性肺疾病(COPD)证据框架项目,这是一项基于证据的对COPD患者治疗策略相关文献的综述。该项目源于卫生与长期护理部卫生系统战略司的一项请求,即要求MAS为其提供一个关于COPD干预措施有效性和成本效益的证据平台。在初步审查了卫生技术评估和COPD文献的系统综述,并咨询专家后,MAS确定了以下分析主题:疫苗接种(流感和肺炎球菌)、戒烟、多学科护理、肺康复、长期氧疗、急性和慢性呼吸衰竭的无创正压通气、COPD急性加重期的居家医院治疗以及远程医疗(包括远程监测和电话支持)。针对每个主题都进行了基于证据的分析。对于每项技术,还在适当情况下完成了经济分析。此外,对关于患者、护理人员和提供者对COPD患者生存与死亡看法的定性文献进行了综述,同时也对这些分析中包含的每项技术的定性文献进行了综述。慢性阻塞性肺疾病综合分析系列由以下报告组成,可在MAS网站上公开获取:http://www.hqontario.ca/en/mas/mas_ohtas_mn.html。慢性阻塞性肺疾病(COPD)证据框架。慢性阻塞性肺疾病(COPD)患者的流感和肺炎球菌疫苗接种:基于证据的分析。慢性阻塞性肺疾病(COPD)患者的戒烟:基于证据的分析。稳定期慢性阻塞性肺疾病(COPD)患者的社区多学科护理:基于证据的分析。慢性阻塞性肺疾病(COPD)患者的肺康复:基于证据的分析。慢性阻塞性肺疾病(COPD)患者的长期氧疗:基于证据的分析。慢性阻塞性肺疾病(COPD)急性呼吸衰竭患者的无创正压通气:基于证据的分析。稳定期慢性阻塞性肺疾病(COPD)慢性呼吸衰竭患者的无创正压通气:基于证据的分析。慢性阻塞性肺疾病(COPD)急性加重期患者的居家医院项目:基于证据的分析。慢性阻塞性肺疾病(COPD)患者的家庭远程医疗:基于证据的分析。使用安大略政策模型对慢性阻塞性肺疾病干预措施的成本效益分析。COPD患者生存与死亡的经历:对定性实证文献的系统综述与综合分析。如需了解更多关于定性综述的信息,请联系Mita Giacomini,网址为:http://fhs.mcmaster.ca/ceb/faculty_member_giacomini.htm。如需了解更多关于经济分析的信息,请访问PATH网站:http://www.path-hta.ca/About-Us/Contact-Us.aspx。多伦多卫生经济与技术评估(THETA)协作组编写了一份关于患者对机械通气偏好的相关报告。如需了解更多信息,请访问THETA网站:http://theta.utoronto.ca/static/contact。目的:本分析的目的是比较对于因慢性阻塞性肺疾病(COPD)急性加重期而前往急诊科(ED)就诊的患者,居家医院护理与住院医院护理的效果。临床需求:病情及目标人群:慢性阻塞性肺疾病急性加重期:慢性阻塞性肺疾病是一种以气流受限为特征的疾病状态,且这种气流受限通常是不完全可逆的。这种气流受限通常是进行性的,并且与肺部对有害颗粒或气体的异常炎症反应相关。COPD的自然病程包括症状急性发作加重的时期,特别是呼吸急促、咳嗽和/或咳痰增加,这些超出了正常的日常变化;这些被称为急性加重期。三分之二的COPD加重是由气管支气管树感染或空气污染引起的;其余病例的病因不明。中度至重度COPD患者平均每年经历2至3次加重。加重对患者和医疗保健系统都有重要影响。对患者而言,加重会导致生活质量下降、可能导致肺功能永久性丧失以及死亡风险增加。对医疗保健系统而言,COPD加重是急诊科就诊和住院的主要原因,尤其是在冬季。技术:居家医院项目为因COPD加重而前往急诊科就诊且需要住院治疗的患者提供了一种替代方案。居家医院项目为患者提供医疗专业人员(通常是专科护士)到家中探访,这些人员监测患者,如有需要可更改患者的治疗计划,并且在一些项目中,还提供额外的护理,如肺康复、患者及护理人员教育以及戒烟咨询。居家医院项目有两种类型:避免住院和早期出院居家医院。在前者,即避免住院居家医院项目中,患者在急诊科接受评估后,会被开具必要的药物和所需的额外护理(如氧疗),然后送回家中,在那里他们会接受医疗专业人员的定期探访。在早期出院居家医院项目中,患者在急诊科接受评估后会被收治入院,在医院接受治疗的初始阶段。在加重期尚未缓解之前,这些患者会被转至居家医院项目。在这两种情况下,一旦加重期缓解,患者就会从居家医院项目出院,不再在家中接受探访。在现有的模式中,居家医院项目与其他家庭护理项目不同,因为它们处理的是需要更高护理 acuity 的病情较重的患者,并且医院对患者保留医疗和法律责任。此外,需要家庭护理服务的患者可能需要此类服务很长时间或无限期,而居家医院项目中的患者仅在短时间内需要并接受此类服务。居家医院护理并不适合所有COPD急性加重期患者。不符合条件的患者包括:那些轻度加重且无需住院即可处理的患者;那些需要住院治疗的患者;以及那些由于医疗原因和/或家中缺乏或社会支持不佳而无法在居家医院项目中安全治疗的患者。居家医院治疗COPD加重期的潜在益处包括:通过避免住院和/或缩短住院时间减少医疗保健资源的利用;降低成本;在家中接受治疗时患者和护理人员与健康相关的生活质量提高;以及在这个易感患者群体中降低医院获得性感染的风险。安大略省背景:在安大略省未发现用于治疗COPD急性加重期的居家医院项目。因加重期需要急性护理的患者在医院接受治疗。研究问题:与住院医院护理相比,居家医院护理对COPD急性加重期的有效性、成本效益和安全性如何?研究方法:文献检索:检索策略:2010年8月5日进行了文献检索,使用OVID MEDLINE、OVID MEDLINE在研及其他未索引引文、OVID EMBASE、EBSCO护理与联合健康文献累积索引(CINAHL)、Wiley Cochrane图书馆以及综述与传播中心数据库,检索1990年1月1日至2010年8月5日发表的研究。由一名评审员审查摘要,对于符合纳入标准的研究,获取全文文章。还检查了参考文献列表和卫生技术评估网站,以查找通过系统检索未发现的任何其他相关研究。纳入标准:英文全文报告;卫生技术评估、系统综述、荟萃分析和随机对照试验(RCT);专门针对诊断为COPD的患者进行的研究,或者包括COPD患者以及其他疾病患者的研究(如果分别报告了COPD患者的结果);针对因COPD急性加重期而前往急诊科就诊的患者进行的研究;1990年1月1日至2010年8月5日发表的研究;比较居家医院护理和住院医院护理对COPD急性加重期患者的研究;包括至少一项感兴趣结果(如下所列)的研究。Cochrane协作网综述将居家医院项目定义为那些由医疗专业人员在患者家中为其急性加重期提供有限时间积极治疗的项目(在这种情况下,直到加重期缓解)。如果没有居家医院项目,这些患者将被收治入院接受治疗。排除标准:年龄小于18岁;动物研究;重复发表;灰色文献。感兴趣的结果:患者/临床结果:死亡率;肺功能(一秒用力呼气量);与健康相关的生活质量;患者或护理人员的偏好;患者或护理人员对护理的满意度;并发症。卫生系统结果:医院再入院;住院和居家医院的住院时间。急诊科就诊;转至长期护理;再入院天数;居家医院资格。统计方法:尽可能使用Review Manager 5版本5.1合并结果;否则,对结果进行描述性总结。使用意向性分析方案分析RCT的数据。此外,进行了敏感性分析,将所有缺失数据/退出病例视为发生该事件。P值小于0.05被认为具有统计学意义。预先计划对居家医院项目的 acuity、居家医院项目类型(早期出院或避免住院)以及患者COPD的严重程度进行亚组分析。根据已识别的文献,在需要时进行了额外的亚组分析。使用STATA 10.1进行事后样本量计算。证据质量:考虑分配隐藏、随机化、盲法、功效/样本量、退出/失访以及意向性分析等因素,对每项纳入研究的质量进行评估。根据GRADE工作组标准,将证据体的质量评估为高、中、低或极低。在对证据质量进行分级时使用了以下质量定义:[表格:见正文]结果总结:十四项研究符合纳入标准并被纳入本综述:1项卫生技术评估、5项系统综述和7项RCT。以下结论基于低至极低质量的证据。所审查的证据基于RCT,这些RCT的功效不足以观察到居家医院护理和住院医院护理在大多数结果上的差异,因此存在很强的II类错误可能性。鉴于证据质量低至极低,这些结论必须谨慎考虑。因COPD急性加重期而前往急诊科就诊的患者中,约21%至37%可能符合居家医院护理的条件。在符合护理条件的患者中,一些可能会拒绝参与居家医院护理。根据居家医院项目的设计,如居家医院的地理服务区域大小以及患者评估和进入居家医院的运营时间,居家医院护理的资格可能会增加。与住院医院护理相比,在2至6个月的随访期间,COPD急性加重期的居家医院护理与死亡率和医院再入院风险的非显著降低相关。有限的、极低质量的证据表明,与接受住院医院护理的患者相比,接受居家医院护理的患者医院再入院延迟(居家医院护理与住院医院护理相比,再入院前平均额外天数为4至38天)。没有足够的证据来确定与住院医院护理相比,居家医院护理是否与肺功能改善相关。大多数研究在随访时未发现居家医院护理和住院医院护理在各种与健康相关的生活质量测量指标上有显著差异。然而,随访可能为时已晚,无法观察到居家医院护理对生活质量的影响。由于证据有限且不一致,无法确定居家医院护理对初始加重期住院时间(分别定义为住院天数或住院天数加居家医院护理天数,适用于住院医院和居家医院)的影响。患者和护理人员对居家医院护理和住院医院护理的护理满意度都很高。