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Considerations Before Selecting a Stepped-Wedge Cluster Randomized Trial Design for a Practice Improvement Study 为实践改进研究选择楔形步进式随机试验设计前的考虑
Pub Date : 2022-05-01 DOI: 10.1370/afm.2810
P. M. Ann M. Nguyen, PhD Charles M. Cleland, PhD L. Miriam Dickinson, Michael P. Barry, MD Samuel Cykert, M. M. F. Daniel Duffy, M. M. Anton J. Kuzel, PhD Stephan R. Lindner, M. M. Michael L. Parchman, M. M. Donna R. Shelley, PhD Theresa L. Walunas
PURPOSE Despite the growing popularity of stepped-wedge cluster randomized trials (SW-CRTs) for practice-based research, the design’s advantages and challenges are not well documented. The objective of this study was to identify the advantages and challenges of the SW-CRT design for large-scale intervention implementations in primary care settings. METHODS The EvidenceNOW: Advancing Heart Health initiative, funded by the Agency for Healthcare Research and Quality, included a large collection of SW-CRTs. We conducted qualitative interviews with 17 key informants from EvidenceNOW grantees to identify the advantages and challenges of using SW-CRT design. RESULTS All interviewees reported that SW-CRT can be an effective study design for large-scale intervention implementations. Advantages included (1) incentivized recruitment, (2) staggered resource allocation, and (3) statistical power. Challenges included (1) time-sensitive recruitment, (2) retention, (3) randomization requirements and practice preferences, (4) achieving treatment schedule fidelity, (5) intensive data collection, (6) the Hawthorne effect, and (7) temporal trends. CONCLUSIONS The challenges experienced by EvidenceNOW grantees suggest that certain favorable real-world conditions constitute a context that increases the odds of a successful SW-CRT. An existing infrastructure can support the recruitment of many practices. Strong retention plans are needed to continue to engage sites waiting to start the intervention. Finally, study outcomes should be ones already captured in routine practice; otherwise, funders and investigators should assess the feasibility and cost of data collection. VISUAL ABSTRACT
尽管在基于实践的研究中,楔形聚类随机试验(sw - crt)越来越受欢迎,但其设计的优势和挑战并没有很好的文献记载。本研究的目的是确定SW-CRT设计在初级保健环境中大规模干预实施的优势和挑战。方法循证now:推进心脏健康计划,由医疗保健研究和质量局资助,包括大量的sw - crt收集。我们对来自evidence - enow受助人的17名关键线人进行了定性访谈,以确定使用SW-CRT设计的优势和挑战。结果所有受访者都认为SW-CRT可以作为大规模干预实施的有效研究设计。优势包括:(1)激励招聘;(2)错开资源分配;(3)统计能力。挑战包括:(1)时间敏感的招募,(2)保留,(3)随机化要求和实践偏好,(4)实现治疗计划的保密性,(5)密集的数据收集,(6)霍桑效应,(7)时间趋势。结论:evidence enow受助人所经历的挑战表明,某些有利的现实条件构成了增加SW-CRT成功几率的环境。现有的基础结构可以支持许多实践的招募。需要强有力的留存计划来继续吸引等待开始干预的网站。最后,研究结果应该是在日常实践中已经获得的;否则,资助者和调查人员应评估数据收集的可行性和成本。视觉文摘
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引用次数: 6
DEPARTMENTS OF FAMILY MEDICINE MEETING POST-COVID NEEDS 满足疫情后需求的家庭医学部门
Pub Date : 2022-05-01 DOI: 10.1370/afm.2834
K. Narasimhan, Richard Lord
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引用次数: 0
BUILDING PRIORITIES IN HEALTH & HEALTH CARE INTO ABFM’S KNOWLEDGE ASSESSMENTS 将健康和保健方面的优先事项纳入abfm的知识评估
Pub Date : 2022-05-01 DOI: 10.1370/afm.2840
W. Newton, Lara J. Handler, M. Magill
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引用次数: 0
Creating Avenues to Specialty Care—Could COVID-19 Force Change in the Way We Access Specialty Care? 创造专科护理途径——COVID-19会改变我们获得专科护理的方式吗?
Pub Date : 2022-05-01 DOI: 10.1370/afm.2836
Jessica Motley, M. Johansen
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引用次数: 0
Randomized Trials in Primary Care: Becoming Pragmatic 初级保健的随机试验:变得务实
Pub Date : 2022-05-01 DOI: 10.1370/afm.2832
M. Marino, J. Heintzman
society, but has also reminded us anew of the limitations and challenges of our scientific approaches. Take the example of randomized trials. While multiple randomized trials were demonstrating the efficacy and safety of SARSCoV-2 vaccines,1 it became clear that other interventions against SARS-CoV-2 (eg, community masking, physical distancing, school closures, national lockdowns, etc) required research paradigms outside of the classic randomized trial design to which many scientists are accustomed.2,3 This again reminds us that randomized trials may have significant practical limitations to their generalizability because they are in tightly controlled settings with narrow eligibility, and therefore often in settings divorced from the real world.4 Whereas classic randomized trials evaluate interventions in ideal settings, pragmatic trials evaluate interventions against real-world alternatives provided in routine care (especially in primary care). Typically, pragmatic trials also relax eligibility criteria which may allow for greater generalizability of study findings. With the benefit of generalizability, however, comes challenges that are unique to pragmatic trials. To balance the relative risks and benefits of both of these designs, investigators employ strategies that often hybridize the 2 designs to maximize benefit and minimize limitation. In this issue, 3 studies demonstrate increasingly used approaches to construct trials that are pragmatic, but retain features and benefits of classic trial design. First, a randomized controlled trial led by Mitchell et al5 sought to evaluate the relative effectiveness of additions to a nationally disseminated readmission reduction program (called Re-Engineered Discharge [RED]) to reduce hospital readmission rates and emergency department visits among depressed patients. In intent-to-treat (ITT) analyses, the study found no difference in all-cause hospitalization between the study arms. Intent-to-treat analyses are used in trials to account for real-word deviation from treatment, and include all randomized study participants in prespecified analyses regardless of events after they are randomized (eg, noncompliance, study withdrawal, protocol deviation, etc). Intent-to-treat analyses are thought to produce less bias than when the randomized participants who were entirely adherent to their assigned intervention are included in this analysis.6 An alternative to an intent-to-treat analysis is to consider as-treated analyses which compares intervention groups that only include patients who actually received the treatment(s) without regard to their randomized assignment.6 In addition to intent-to-treat analyses, Mitchell et al5 also performed as-treated analyses and found that with sufficient uptake of the adapted RED intervention, patients saw a larger decrease in hospital readmission compared with RED alone. While it is tempting to consider the as-treated analysis a definitive analysis, it is known that as-tre
社会,但也再次提醒我们,我们的科学方法的局限性和挑战。以随机试验为例。虽然多项随机试验证明了SARS-CoV-2疫苗的有效性和安全性,但很明显,针对SARS-CoV-2的其他干预措施(例如,社区屏蔽、保持身体距离、学校关闭、国家封锁等)需要在许多科学家习惯的经典随机试验设计之外的研究范式。这再次提醒我们,随机试验在推广方面可能存在显著的实际限制,因为它们是在严格控制的环境中,具有狭窄的资格,因此通常是在与现实世界分离的环境中经典的随机试验评估的是理想环境下的干预措施,而实用试验评估的是常规护理(尤其是初级保健)中提供的现实世界替代方案的干预措施。通常,实用试验也放宽资格标准,这可能使研究结果具有更大的普遍性。然而,随着概括性的好处,实用性试验也面临着独特的挑战。为了平衡这两种设计的相对风险和收益,研究人员通常采用混合两种设计的策略来最大化收益和最小化限制。在本期中,有3项研究表明,越来越多的方法被用于构建实用的试验,但保留了经典试验设计的特征和优点。首先,由Mitchell等人领导的一项随机对照试验5试图评估在全国范围内传播的再入院减少计划(称为重新设计出院[RED])中增加的相对有效性,以减少抑郁症患者的再入院率和急诊就诊次数。在意向治疗(ITT)分析中,研究发现两组的全因住院率没有差异。意向治疗分析在试验中用于解释与治疗的实际偏差,并将所有随机研究参与者包括在预先指定的分析中,而不管他们随机化后的事件(例如,不遵守,研究退出,协议偏差等)。意向治疗分析被认为比完全遵守其指定干预措施的随机参与者纳入该分析时产生的偏差更小意向治疗分析的另一种选择是考虑已治疗分析,即只包括实际接受治疗的患者而不考虑其随机分配的干预组除了意向治疗分析外,Mitchell等人5还进行了治疗分析,发现与单独使用RED干预相比,充分采用适应性RED干预的患者再入院率下降幅度更大。虽然人们很容易认为经处理的分析是一种决定性的分析,但众所周知,经处理的分析更有可能存在偏见,并夸大治疗效果在现实环境中,完全坚持任何干预措施都是一个挑战。报告ITT分析和治疗分析为初级保健临床医生和研究人员提供了一个完整的画面,以便将研究结果纳入背景。接下来,Orrego等人提出了一项集群随机试验,该试验评估了虚拟实践社区在改善初级卫生保健专业人员对慢性病患者赋权的态度方面的有效性。“集群随机化”是一种使试验在本质上更加务实的方法。在这种方法中,参与者是随机分组的(例如,初级保健诊所,卫生保健专业人员等),这有几个好处,特别是当干预的目标是在实践或卫生系统水平。考虑集群随机试验的一个主要原因是为了避免污染偏倚(例如,被随机分配到对照组的卫生保健专业人员采用了干预措施)本研究没有将患者随机分配到干预组或对照组,而是将63个初级保健实践随机分配到研究组。考虑这种设计的研究人员应该意识到,这些益处必须与潜在的局限性进行评估,包括诊所/系统规模可能的不平衡,以及广泛的提供者和患者编辑
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引用次数: 0
Gifts From Unexpected Places 来自意想不到的地方的礼物
Pub Date : 2022-05-01 DOI: 10.1370/afm.2793
Adrienne Feller Novick
When I was a new social worker, a series of events changed my clinical practice. I believed academic pursuits and scholarly work were the key components to cultivating my clinical skills. My education had elucidated the importance of taking the time to listen to the patient’s narrative to optimize their care. I recognized the value of listening and yet I was mystified and frustrated by my lack of success at building rapport with patients. I began my quest to find a mentor and discovered him in a most surprising place. I learned the best strategies to help people were not always found in books or taught in school. Some of the greatest gifts come from unexpected places.
当我还是一名新的社会工作者时,一系列的事件改变了我的临床实践。我相信学术追求和学术工作是培养我临床技能的关键组成部分。我所受的教育告诉我,花时间倾听病人的叙述对优化护理的重要性。我认识到倾听的价值,但我对自己在与病人建立融洽关系方面的失败感到困惑和沮丧。我开始寻找导师,并在一个最令人惊讶的地方找到了他。我了解到,帮助别人的最佳策略并不总是在书本上或学校里教的。一些最伟大的礼物来自意想不到的地方。
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引用次数: 0
Integrating General Practice Into the Australian COVID-19 Response: A Description of the General Practitioner Respiratory Clinic Program in Australia 将全科医生纳入澳大利亚COVID-19应对措施:澳大利亚全科医生呼吸诊所计划的描述
Pub Date : 2022-05-01 DOI: 10.1370/afm.2808
S. Davis, Leslee Roberts, J. Desborough, Sally Hall Dykgraaf, P. Burns, Michael Kidd, R. Maddox, Lucas de Toca, K. Lokuge
Integrating primary care with the health response is key to managing pandemics and other health emergencies. In recognition of this, the Australian Government established a network of respiratory clinics led by general practitioners in response to the coronavirus disease 2019 (COVID-19) pandemic as part of broader measures aimed at supporting primary care. General practitioner (GP) respiratory clinics provide holistic face-to-face assessment and treatment to those with respiratory symptoms in an environment with strict protocols for infection prevention and control. This ensures that these patients are able to access high quality primary care while protecting the general practice workforce and other patients. The GP respiratory clinic model was developed and operationalized 10 days after the policy was announced, with the first 2 respiratory clinics opening on March 21, 2020. Subsequently a total of 150 respiratory clinics were opened and served over 800,000 patients within more than 99% of Australia’s postcodes. These clinics used a standardized data collection tool that has provided the largest and most complete primary care surveillance database of respiratory illness in Australia. The success of the GP respiratory clinic model was made possible due to strong partnerships with Primary Health Networks and individual general practices that rapidly shifted operations to embrace this new approach. This article describes the development and early implementation of this model.
将初级保健纳入卫生应对工作是管理大流行病和其他突发卫生事件的关键。认识到这一点,澳大利亚政府建立了一个由全科医生领导的呼吸道诊所网络,以应对2019年冠状病毒病(COVID-19)大流行,作为旨在支持初级保健的更广泛措施的一部分。全科医生呼吸科诊所为有呼吸道症状的人士提供全面的面对面评估和治疗,并设有严格的感染预防和控制程序。这确保了这些患者能够获得高质量的初级保健,同时保护全科医生和其他患者。全科医生呼吸系统诊所模式在政策公布10天后开发并运行,首批2家呼吸系统诊所于2020年3月21日开业。随后,总共开设了150家呼吸道诊所,为超过80万名患者提供服务,覆盖了澳大利亚99%以上的邮政编码。这些诊所使用标准化的数据收集工具,提供了澳大利亚最大和最完整的呼吸道疾病初级保健监测数据库。全科医生呼吸系统诊所模式的成功是由于与初级卫生网络和个人全科诊所建立了强有力的伙伴关系,迅速将业务转移到采用这种新方法。本文描述了该模型的开发和早期实现。
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引用次数: 2
Lung Ultrasound Performed by Primary Care Physicians for Clinically Suspected Community-Acquired Pneumonia: A Multicenter Prospective Study 初级保健医生对临床疑似社区获得性肺炎进行肺部超声检查:一项多中心前瞻性研究
Pub Date : 2022-05-01 DOI: 10.1370/afm.2796
F. J. Rodríguez-Contreras, Antonio Calvo-Cebrián, Juncal Díaz-Lázaro, M.L. Cruz-Arnes, Fernando León-Vázquez, María del Carmen Lobón-Agúndez, Francisco Javier Palau-Cuevas, Paloma Henares-García, Fernando Gavilán-Martínez, S. Fernández-Plaza, Carmelo Prieto-Zancudo
PURPOSE We investigated whether lung ultrasound (US) performed in primary care is useful and feasible for diagnosing community-acquired pneumonia (CAP) compared with chest radiography, as most previous research has been conducted in hospital settings. METHODS We undertook a prospective observational cohort study of lung US performed in 12 primary care centers. Patients aged 5 years and older with symptoms suggesting CAP were examined with lung US (by 21 family physicians and 7 primary care pediatricians) and chest radiograph on the same day. We compared lung US findings with the radiologist’s chest radiograph report as the reference standard, given that the latter is the most common imaging test performed for suspected CAP in primary care. The physicians had varied previous US experience, but all received a 5-hour lung US training program. RESULTS The study included 82 patients. Compared with chest radiography, positive lung US findings (consolidation measuring >1 cm or a focal/asymmetrical B-lines pattern) showed a sensitivity of 87.8%, a specificity of 58.5%, a positive likelihood-ratio of 2.12, and a negative likelihood-ratio of 0.21. Findings were similar regardless of the physicians’ previous US training or experience. We propose a practical algorithm whereby patients having consolidation measuring greater than 1 cm or normal findings on lung US could skip chest radiography, whereas patients with a B-lines pattern without consolidation (given its low specificity) would need chest radiography to ensure appropriate management. Lung US was generally performed in 10 minutes or less. CONCLUSION Point-of-care lung US in primary care could be useful for investigating suspected CAP (avoiding chest radiography in most cases) and is likely feasible in daily practice, as short training programs appear sufficient and little time is needed to perform the scan.
目的:与胸片相比,我们调查了在初级保健中进行的肺部超声(US)对诊断社区获得性肺炎(CAP)是否有用和可行,因为大多数先前的研究都是在医院环境中进行的。方法:我们在12个初级保健中心进行了一项肺部US的前瞻性观察队列研究。5岁及以上有CAP症状的患者在同一天接受肺超声检查(由21名家庭医生和7名初级保健儿科医生)和胸片检查。考虑到后者是初级保健中对疑似CAP最常见的影像学检查,我们将肺超声检查结果与放射科医生的胸片报告作为参考标准进行了比较。这些医生之前有不同的美国经验,但都接受了5小时的美国肺部培训计划。结果纳入82例患者。与胸片相比,肺US阳性表现(实变>1 cm或局灶性/不对称b线模式)的敏感性为87.8%,特异性为58.5%,阳性似然比为2.12,阴性似然比为0.21。无论医生之前在美国接受的培训或经历如何,研究结果都是相似的。我们提出了一种实用的算法,即实变测量大于1厘米或肺超声检查结果正常的患者可以跳过胸片检查,而没有实变的b线型患者(鉴于其低特异性)则需要胸片检查以确保适当的管理。肺超声一般在10分钟或更短时间内完成。结论:初级保健中的即时肺部超声检查可用于调查疑似CAP(在大多数情况下避免胸部x线摄影),并且在日常实践中可能是可行的,因为短期培训计划似乎足够,并且需要很少的时间进行扫描。
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引用次数: 1
STFM TASK FORCE RELEASES A STANDARDIZED FAMILY MEDICINE SUB-INTERNSHIP CURRICULUM STFM工作组发布标准化家庭医学实习分课程
Pub Date : 2022-05-01 DOI: 10.1370/afm.2839
Emily Walters, Tomoko Sairenji
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引用次数: 0
Reducing Readmission of Hospitalized Patients With Depressive Symptoms: A Randomized Trial 减少抑郁症状住院患者再入院:一项随机试验
Pub Date : 2022-05-01 DOI: 10.1370/afm.2801
S. Mitchell, Matthew Reichert, J. Howard, Katherine Krizman, Alexa Bragg, Molly Huffaker, Kimberly N Parker, Mary Cawley, Hannah Webb Roberts, Yena Sung, Jennifer Brown, L. Culpepper, H. Cabral, Brian W. Jack
PURPOSE To determine if hospitalized patients with depressive symptoms will benefit from post-discharge depression treatment with care transition support. METHODS This is a randomized controlled trial of hospitalized patients with patient health questionnaire-9 score of 10 or more. We delivered the Re-Engineered Discharge (RED) and randomized participants to groups receiving RED-only or RED for Depression (RED-D), a 12-week post-discharge telehealth intervention including cognitive behavioral therapy, self-management support, and patient navigation. Primary outcomes were hospital readmission and reutilization rates at 30 and 90 days post discharge. RESULTS We randomized 709 participants (353 RED-D, 356 RED-only). At 90 days, 265 (75%) intervention participants had received at least 1 RED-D session (median 4). At 30 days, the intention-to-treat analysis showed no differences between RED-D vs RED-only in hospital readmission (9% vs 10%, incidence rate ratio [IRR] 0.92 [95% CI, 0.56-1.52]) or reutilization (27% vs 24%, IRR 1.14 [95% CI, 0.85-1.54]). The intention-to-treat analysis also showed no differences at 90 days in readmission (28% vs 21%, IRR 1.30 [95% CI, 0.95-1.78]) or reutilization (70% vs 57%, IRR 1.22 [95% CI, 1.01-1.49]). In the as-treated analysis, each additional RED-D session was associated with a decrease in 30- and 90-day readmissions. At 30 days, among 104 participants receiving 3 or more sessions, there were fewer readmissions (3% vs 10%, IRR 0.30 [95% CI, 0.07-0.84]) compared with the control group. At 90 days, among 109 participants receiving 6 or more sessions, there were fewer readmissions (11% vs 21%, IRR 0.52 [95% CI, 0.27-0.92]). Intention-to-treat analysis showed no differences between study groups on secondary outcomes. CONCLUSIONS Care transition support and post-discharge depression treatment can reduce unplanned hospital use with sufficient uptake of the RED-D intervention.
目的:确定有抑郁症状的住院患者是否能从出院后抑郁治疗和护理过渡支持中获益。方法:本研究是一项随机对照试验,纳入患者健康问卷-9得分在10分及以上的住院患者。我们进行了重新设计出院(RED),并将参与者随机分为仅接受RED或接受RED for Depression (RED- d)的组,这是一项为期12周的出院后远程医疗干预,包括认知行为治疗、自我管理支持和患者导航。主要结局是出院后30天和90天的再入院率和再利用率。结果:我们随机分配了709名参与者(353名RED-D, 356名RED-only)。在第90天,265名(75%)干预参与者接受了至少1次RED-D治疗(中位数为4次)。在第30天,意向治疗分析显示,RED-D治疗与RED-D治疗在再入院(9% vs 10%,发病率比[IRR] 0.92 [95% CI, 0.56-1.52])或再利用率(27% vs 24%, IRR 1.14 [95% CI, 0.85-1.54])方面没有差异。意向治疗分析也显示,90天的再入院率(28%对21%,IRR 1.30 [95% CI, 0.95-1.78])或再使用率(70%对57%,IRR 1.22 [95% CI, 1.01-1.49])无差异。在治疗后的分析中,每增加一次RED-D治疗与30天和90天再入院的减少有关。在第30天,接受3次或以上治疗的104名参与者中,与对照组相比,再入院人数较少(3% vs 10%, IRR 0.30 [95% CI, 0.07-0.84])。在第90天,109名接受6次或更多疗程的参与者中,再入院人数较少(11%对21%,IRR 0.52 [95% CI, 0.27-0.92])。意向治疗分析显示两组在次要结局上没有差异。结论:充分采用RED-D干预措施,护理过渡支持和出院后抑郁治疗可减少计划外住院。
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引用次数: 3
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The Annals of Family Medicine
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