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Measuring Health-Related Quality of Life in Randomised Controlled Trials: Expected and Reported Results Do Not Match 在随机对照试验中测量与健康相关的生活质量:预期结果和报告结果不匹配
IF 8.9 Q2 MEDICINE, GENERAL & INTERNAL Pub Date : 2022-04-01 DOI: 10.2147/POR.S350165
F. Wiedemann, F. Porzsolt
Purpose The assessment of health-related quality of life (hrQoL) may need to be reconsidered due to important differences between efficacy (the effect of a treatment under experimental study conditions) and effectiveness (the effect of a treatment under real-world conditions). We presume that most researchers intend to describe effects under real-world conditions when investigating hrQoL as an endpoint. Unfortunately, most studies are designed to confirm two theories: the efficacy of a new intervention under experimental study conditions and the real-world effectiveness of this intervention on hrQoL under non-experimental study conditions. Conflicting information emerges when the outcomes are supposed to describe effects under real-world conditions, but the assessment generates results obtained under experimental conditions. This paper examines the existing conflict between efficacy and effectiveness in a sample of 100 studies investigating hrQoL. Methods We analysed a sample of freely available publications of clinical studies listed in PubMed between April 2015 and August 2016 which assessed quality of life as an outcome. We assessed the following four characteristics that should differ in studies measuring either efficacy or effectiveness: 1) specification of the study as a randomised controlled trial or not, 2) description of the study design as pragmatic or not, 3) classification of the study as an efficacy or an effectiveness study and 4) number of selected inclusion and exclusion criteria. Results 91% of the studies assessed hrQoL under experimental conditions (in a randomised controlled trial), but not under real-world conditions. The important difference between efficacy and effectiveness was not described in 60% of the studies. Only 6% of studies classified the study as a pragmatic trial. The difference between inclusion and exclusion criteria was not addressed in any of the investigated studies. Conclusion The results of the four criteria confirmed our hypothesis that hrQoL studies are conducted mainly as experimental, but not pragmatic, trials indicating that the meaningfulness of the important difference between efficacy and effectiveness requires further discussion. Keywords pragmatic trial, experimental study conditions, real-world conditions, efficacy, effectiveness, pragmatic.
目的健康相关生活质量(hrQoL)的评估可能需要重新考虑,因为疗效(在实验研究条件下的治疗效果)和有效性(在现实世界条件下的疗效)之间存在重要差异。我们推测,大多数研究人员在研究hrQoL作为终点时,都打算描述现实世界条件下的影响。不幸的是,大多数研究都是为了证实两种理论:一种是在实验研究条件下新干预措施的有效性,另一种是该干预措施在非实验性研究条件下对hrQoL的真实有效性。当结果本应描述真实世界条件下的效果,但评估产生了在实验条件下获得的结果时,就会出现冲突信息。本文以100项调查hrQoL的研究为样本,检验了疗效和有效性之间存在的冲突。方法我们分析了2015年4月至2016年8月期间PubMed上列出的免费临床研究出版物的样本,这些出版物评估了生活质量作为一种结果。我们评估了以下四个特征,这些特征在衡量疗效或有效性的研究中应该有所不同:1)是否将研究指定为随机对照试验,2)将研究设计描述为实用或不实用,3)将研究分类为疗效或有效研究,以及4)选择的纳入和排除标准的数量。结果91%的研究在实验条件下(在一项随机对照试验中)评估了hrQoL,但在现实世界条件下没有评估。60%的研究没有描述疗效和有效性之间的重要差异。只有6%的研究将该研究归类为语用试验。纳入标准和排除标准之间的差异在任何调查研究中都没有得到解决。结论四个标准的结果证实了我们的假设,即hrQoL研究主要是作为实验而非务实的试验进行的,表明疗效和有效性之间的重要差异的意义需要进一步讨论。语用试验,实验研究条件,现实世界条件,疗效,有效性,语用学。
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引用次数: 0
Deriving a Standardised Recommended Respiratory Disease Codelist Repository for Future Research. 为未来研究建立一个标准化的推荐呼吸系统疾病代码库。
IF 8.9 Q2 MEDICINE, GENERAL & INTERNAL Pub Date : 2022-02-16 eCollection Date: 2022-01-01 DOI: 10.2147/POR.S353400
Clare MacRae, Hannah Whittaker, Mome Mukherjee, Luke Daines, Ann Morgan, Chukwuma Iwundu, Mohammed Alsallakh, Eleftheria Vasileiou, Eimear O'Rourke, Alexander T Williams, Philip W Stone, Aziz Sheikh, Jennifer K Quint

Background: Electronic health record (EHR) databases provide rich, longitudinal data on interactions with healthcare providers and can be used to advance research into respiratory conditions. However, since these data are primarily collected to support health care delivery, clinical coding can be inconsistent, resulting in inherent challenges in using these data for research purposes.

Methods: We systematically searched existing international literature and UK code repositories to find respiratory disease codelists for asthma from January 2018, and chronic obstructive pulmonary disease and respiratory tract infections from January 2020, based on prior searches. Medline searches using key terms provided in article lists. Full-text articles, supplementary files, and reference lists were examined for codelists, and codelists repositories were searched. A reproducible methodology for codelists creation was developed with recommended lists for each disease created based on multidisciplinary expert opinion and previously published literature.

Results: Medline searches returned 1126 asthma articles, 70 COPD articles, and 90 respiratory infection articles, with 3%, 22% and 5% including codelists, respectively. Repository searching returned 12 asthma, 23 COPD, and 64 respiratory infection codelists. We have systematically compiled respiratory disease codelists and from these derived recommended lists for use by researchers to find the most up-to-date and relevant respiratory disease codelists that can be tailored to individual research questions.

Conclusion: Few published papers include codelists, and where published diverse codelists were used, even when answering similar research questions. Whilst some advances have been made, greater consistency and transparency across studies using routine data to study respiratory diseases are needed.

背景:电子健康记录(EHR)数据库提供了与医疗保健提供者互动的丰富的纵向数据,可用于推进呼吸疾病的研究。然而,由于收集这些数据主要是为了支持卫生保健服务,因此临床编码可能不一致,从而导致在将这些数据用于研究目的方面存在固有挑战。方法:我们系统地检索现有的国际文献和英国代码库,以查找2018年1月的哮喘和2020年1月的慢性阻塞性肺疾病和呼吸道感染的呼吸道疾病代码库。Medline使用文章列表中提供的关键字进行搜索。全文文章、补充文件和参考文献列表被检查以查找代码列表,并搜索代码列表存储库。根据多学科专家意见和以前发表的文献,制定了一种可重复的清单编制方法,并为每种疾病编制了推荐清单。结果:Medline检索返回1126篇哮喘文章,70篇COPD文章和90篇呼吸道感染文章,分别有3%,22%和5%包含codelists。信息库检索得到12名哮喘、23名慢性阻塞性肺病和64名呼吸道感染病例。我们系统地编制了呼吸系统疾病编码清单,并从这些衍生出的推荐清单中,供研究人员使用,以找到最新和相关的呼吸系统疾病编码清单,这些清单可以针对个别研究问题进行定制。结论:很少有已发表的论文包含codelist,并且即使在回答类似的研究问题时,也使用了不同的codelist。虽然取得了一些进展,但需要在使用常规数据研究呼吸系统疾病的研究中提高一致性和透明度。
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引用次数: 2
Risk Predictors and Symptom Features of Long COVID Within a Broad Primary Care Patient Population Including Both Tested and Untested Patients. 在包括接受过检测和未接受过检测的患者在内的广泛初级保健患者群体中,长期 COVID 的风险预测因素和症状特征。
IF 8.9 Q2 MEDICINE, GENERAL & INTERNAL Pub Date : 2021-08-11 eCollection Date: 2021-01-01 DOI: 10.2147/POR.S316186
Rupert Jones, Andrew Davis, Brooklyn Stanley, Steven Julious, Dermot Ryan, David J Jackson, David M G Halpin, Katherine Hickman, Hilary Pinnock, Jennifer K Quint, Kamlesh Khunti, Liam G Heaney, Phillip Oliver, Salman Siddiqui, Ian Pavord, David H M Jones, Michael Hyland, Lewis Ritchie, Pam Young, Tony Megaw, Steve Davis, Samantha Walker, Stephen Holgate, Sue Beecroft, Anu Kemppinen, Francis Appiagyei, Emma-Jane Roberts, Megan Preston, Antony Hardjojo, Victoria Carter, Marije van Melle, David Price

Introduction: Symptoms may persist after the initial phases of COVID-19 infection, a phenomenon termed long COVID. Current knowledge on long COVID has been mostly derived from test-confirmed and hospitalized COVID-19 patients. Data are required on the burden and predictors of long COVID in a broader patient group, which includes both tested and untested COVID-19 patients in primary care.

Methods: This is an observational study using data from Platform C19, a quality improvement program-derived research database linking primary care electronic health record data (EHR) with patient-reported questionnaire information. Participating general practices invited consenting patients aged 18-85 to complete an online questionnaire since 7th August 2020. COVID-19 self-diagnosis, clinician-diagnosis, testing, and the presence and duration of symptoms were assessed via the questionnaire. Patients were considered present with long COVID if they reported symptoms lasting ≥4 weeks. EHR and questionnaire data up till 22nd January 2021 were extracted for analysis. Multivariable regression analyses were conducted comparing demographics, clinical characteristics, and presence of symptoms between patients with long COVID and patients with shorter symptom duration.

Results: Long COVID was present in 310/3151 (9.8%) patients with self-diagnosed, clinician-diagnosed, or test-confirmed COVID-19. Only 106/310 (34.2%) long COVID patients had test-confirmed COVID-19. Risk predictors of long COVID were age ≥40 years (adjusted Odds Ratio [AdjOR]=1.49 [1.05-2.17]), female sex (adjOR=1.37 [1.02-1.85]), frailty (adjOR=2.39 [1.29-4.27]), visit to A&E (adjOR=4.28 [2.31-7.78]), and hospital admission for COVID-19 symptoms (adjOR=3.22 [1.77-5.79]). Aches and pain (adjOR=1.70 [1.21-2.39]), appetite loss (adjOR=3.15 [1.78-5.92]), confusion and disorientation (adjOR=2.17 [1.57-2.99]), diarrhea (adjOR=1.4 [1.03-1.89]), and persistent dry cough (adjOR=2.77 [1.94-3.98]) were symptom features statistically more common in long COVID.

Conclusion: This study reports the factors and symptom features predicting long COVID in a broad primary care population, including both test-confirmed and the previously missed group of COVID-19 patients.

导言:感染 COVID-19 病毒的初期症状可能会持续存在,这种现象被称为长 COVID。目前有关长COVID的知识主要来自经检测确诊的COVID-19患者和住院患者。我们需要在更广泛的患者群体(包括初级保健中已检测和未检测的 COVID-19 患者)中获得有关长 COVID 负担和预测因素的数据:这是一项观察性研究,使用的数据来自 Platform C19,这是一个质量改进计划衍生的研究数据库,将初级医疗电子健康记录数据(EHR)与患者报告的问卷信息联系在一起。自 2020 年 8 月 7 日起,参与研究的全科诊所邀请年龄在 18-85 岁之间的同意患者填写在线问卷。通过问卷对 COVID-19 的自我诊断、临床医生诊断、检测以及症状的存在和持续时间进行评估。如果患者报告的症状持续时间≥4 周,则被视为存在长期 COVID。提取截至 2021 年 1 月 22 日的电子病历和问卷数据进行分析。对长COVID患者和症状持续时间较短的患者的人口统计学、临床特征和症状存在情况进行了多变量回归分析:310/3151(9.8%)名自我诊断、临床医生诊断或测试证实为COVID-19的患者存在长COVID。只有106/310(34.2%)例长COVID患者的COVID-19得到检测证实。长COVID的风险预测因素包括:年龄≥40岁(调整后比值比[AdjOR]=1.49 [1.05-2.17])、女性(adjOR=1.37 [1.02-1.85])、体弱(adjOR=2.39 [1.29-4.27])、急诊就诊(adjOR=4.28 [2.31-7.78])以及因COVID-19症状入院(adjOR=3.22 [1.77-5.79])。疼痛(adjOR=1.70 [1.21-2.39])、食欲不振(adjOR=3.15 [1.78-5.92])、意识模糊和定向障碍(adjOR=2.17 [1.57-2.99])、腹泻(adjOR=1.4 [1.03-1.89])和持续干咳(adjOR=2.77 [1.94-3.98])是长COVID统计中更常见的症状特征:本研究报告了在广泛的初级保健人群中预测长COVID的因素和症状特征,包括检测证实的COVID-19患者和之前漏诊的COVID-19患者。
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引用次数: 0
Acceptability of Vaccination Against COVID-19 Among Healthcare Workers in the Democratic Republic of the Congo. 刚果民主共和国医护人员对接种 COVID-19 疫苗的接受程度。
IF 8.9 Q2 MEDICINE, GENERAL & INTERNAL Pub Date : 2020-10-29 eCollection Date: 2020-01-01 DOI: 10.2147/POR.S271096
Michel Kabamba Nzaji, Leon Kabamba Ngombe, Guillaume Ngoie Mwamba, Deca Blood Banza Ndala, Judith Mbidi Miema, Christophe Luhata Lungoyo, Bertin Lora Mwimba, Aimé Cikomola Mwana Bene, Elisabeth Mukamba Musenga

Purpose: This study aims to estimate the acceptability of a future vaccine against COVID-19 and associated factors if offered in Congolese health-care workers (HCWs), since they have the highest direct exposure to the disease.

Patients and methods: We conducted an analytical cross-sectional study among 23 Congolese referral hospitals, including three university hospitals, located in three towns from March through 30 April 2020. The main outcome variable was healthcare workers' acceptance of a future vaccine against COVID-19. The associated factors of vaccination willingness were identified through a logistic regression analysis.

Results: A sample of 613 HCWs participated in the study and completed the study questionnaire, including 312 (50.9%) men and 301 (49.1%) women. Only 27.7% of HCWs said that they would accept a COVID-19 vaccine if it was available. From the logistic regression analysis, male healthcare workers (ORa=1.17, 95% CI: 1.15-2.60), primarily doctors (ORa=1.59; 95% CI:1.03-2.44) and having a positive attitude towards a COVID-19 vaccine (ORa=11.49; 95% CI: 5.88-22.46) were significantly associated with reporting willingness to be vaccinated.

Conclusion: For acceptability of vaccination against COVID-19 among others education among HCWs is crucial because health professionals' attitudes about vaccines are an important determinant of their own vaccine uptake and their likelihood of recommending the vaccine to their patients.

目的:本研究旨在估算刚果医护人员(HCWs)未来接种 COVID-19 疫苗的可接受性及相关因素,因为他们是直接接触该疾病最多的人群:我们于 2020 年 3 月至 4 月 30 日在位于三个城镇的 23 家刚果转诊医院(包括三家大学医院)开展了一项横断面分析研究。主要结果变量是医护人员对未来接种 COVID-19 疫苗的接受程度。通过逻辑回归分析确定了疫苗接种意愿的相关因素:613名医护人员参与了研究并填写了研究问卷,其中男性312人(50.9%),女性301人(49.1%)。只有 27.7% 的医护人员表示,如果有 COVID-19 疫苗,他们会接受。从逻辑回归分析来看,男性医护人员(ORa=1.17,95% CI:1.15-2.60)、主要是医生(ORa=1.59;95% CI:1.03-2.44)和对 COVID-19 疫苗持积极态度(ORa=11.49;95% CI:5.88-22.46)与表示愿意接种疫苗有显著关系:结论:对医护人员进行 COVID-19 疫苗接种教育对于其他疫苗的可接受性至关重要,因为医护人员对疫苗的态度是决定其自身疫苗接种率以及向患者推荐疫苗可能性的重要因素。
{"title":"Acceptability of Vaccination Against COVID-19 Among Healthcare Workers in the Democratic Republic of the Congo.","authors":"Michel Kabamba Nzaji, Leon Kabamba Ngombe, Guillaume Ngoie Mwamba, Deca Blood Banza Ndala, Judith Mbidi Miema, Christophe Luhata Lungoyo, Bertin Lora Mwimba, Aimé Cikomola Mwana Bene, Elisabeth Mukamba Musenga","doi":"10.2147/POR.S271096","DOIUrl":"10.2147/POR.S271096","url":null,"abstract":"<p><strong>Purpose: </strong>This study aims to estimate the acceptability of a future vaccine against COVID-19 and associated factors if offered in Congolese health-care workers (HCWs), since they have the highest direct exposure to the disease.</p><p><strong>Patients and methods: </strong>We conducted an analytical cross-sectional study among 23 Congolese referral hospitals, including three university hospitals, located in three towns from March through 30 April 2020. The main outcome variable was healthcare workers' acceptance of a future vaccine against COVID-19. The associated factors of vaccination willingness were identified through a logistic regression analysis.</p><p><strong>Results: </strong>A sample of 613 HCWs participated in the study and completed the study questionnaire, including 312 (50.9%) men and 301 (49.1%) women. Only 27.7% of HCWs said that they would accept a COVID-19 vaccine if it was available. From the logistic regression analysis, male healthcare workers (ORa=1.17, 95% CI: 1.15-2.60), primarily doctors (ORa=1.59; 95% CI:1.03-2.44) and having a positive attitude towards a COVID-19 vaccine (ORa=11.49; 95% CI: 5.88-22.46) were significantly associated with reporting willingness to be vaccinated.</p><p><strong>Conclusion: </strong>For acceptability of vaccination against COVID-19 among others education among HCWs is crucial because health professionals' attitudes about vaccines are an important determinant of their own vaccine uptake and their likelihood of recommending the vaccine to their patients.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"11 ","pages":"103-109"},"PeriodicalIF":8.9,"publicationDate":"2020-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/23/74/por-11-103.PMC7605960.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38579669","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Patients with Sore Throat: A Survey of Self-Management and Healthcare-Seeking Behavior in 13 Countries Worldwide. 喉咙痛患者:全球13个国家自我管理和医疗保健寻求行为的调查
IF 8.9 Q2 MEDICINE, GENERAL & INTERNAL Pub Date : 2020-09-10 eCollection Date: 2020-01-01 DOI: 10.2147/POR.S255872
Alike W van der Velden, Aurelio Sessa, Attila Altiner, Antonio Carlos Campos Pignatari, Adrian Shephard

Background: Acute sore throat is one of the most common problems for which patients consult their general practitioner and is a key area for inappropriate antibiotic prescribing. The objective of this study was to investigate patients' attitudes related to healthcare-seeking behavior and self-management of sore throat.

Methods: We conducted an observational, questionnaire-based study across 13 countries (Australia, Brazil, China, France, Germany, Italy, the Philippines, Russia, Saudi Arabia, South Africa, Thailand, the UK and the USA) on respondents who reported having had a sore throat in the previous 12 months. Data were collected on their experiences, contact with healthcare professionals, treatment practices and opinions about antibiotics.

Results: A total of 5196 respondents (approximately 400 per country) completed the survey. Over 80% of respondents sought advice for a sore throat, with 30% consulting a general practitioner. The desire to limit the worsening of symptoms was the main reason for seeking treatment. Other reasons concerned resolving persistent symptoms and reducing the impact on daily life/sleep. Self-management for sore throat was mainly medicated sore throat remedies. "Wanting an antibiotic" was rated much lower (55%) than most other reasons for visiting a doctor, but this differed greatly between countries. The percentage of respondents using antibiotics varied widely, for example, 10% in the UK and 45% in Saudi Arabia. There was considerable variation in the proportion of respondents who thought that antibiotics would be effective against sore throat (from 24% in France to 94% in Saudi Arabia).

Conclusions: Our findings suggest that knowledge of effective treatments for sore throat varied widely. The results of this study should enable healthcare professionals to better anticipate patients' needs. This will support healthcare professionals in their role as antibiotic stewards, helping to reduce the misuse of antibiotics, and further guiding patients towards symptomatic self-management of sore throat.

背景:急性喉咙痛是最常见的问题之一,患者咨询他们的全科医生,是一个关键领域不适当的抗生素处方。摘要本研究的目的在于探讨病患对咽喉痛的就诊态度及自我管理。方法:我们在13个国家(澳大利亚、巴西、中国、法国、德国、意大利、菲律宾、俄罗斯、沙特阿拉伯、南非、泰国、英国和美国)对报告在过去12个月内有喉咙痛的受访者进行了一项观察性、基于问卷的研究。收集了他们的经历、与卫生保健专业人员的接触、治疗做法和对抗生素的意见的数据。结果:共有5196名受访者(每个国家约400人)完成了调查。超过80%的受访者因喉咙痛寻求建议,30%的人咨询全科医生。希望限制症状恶化是寻求治疗的主要原因。其他原因涉及解决持续症状和减少对日常生活/睡眠的影响。咽喉痛的自我管理主要是药物治疗。“需要抗生素”的比例远低于大多数其他看医生的原因(55%),但这在各国之间差异很大。答复者使用抗生素的百分比差别很大,例如,英国为10%,沙特阿拉伯为45%。认为抗生素对喉咙痛有效的答复者比例差异很大(从法国的24%到沙特阿拉伯的94%)。结论:我们的研究结果表明,有效治疗喉咙痛的知识差异很大。这项研究的结果应该使医疗保健专业人员能够更好地预测患者的需求。这将支持卫生保健专业人员发挥抗生素管理员的作用,帮助减少抗生素的滥用,并进一步指导患者对喉咙痛的症状进行自我管理。
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引用次数: 9
The CHRONICLE Study of US Adults with Subspecialist-Treated Severe Asthma: Objectives, Design, and Initial Results. 美国成人亚临床重症哮喘 CHRONICLE 研究:目标、设计和初步结果。
IF 2.3 Q2 MEDICINE, GENERAL & INTERNAL Pub Date : 2020-07-16 eCollection Date: 2020-01-01 DOI: 10.2147/POR.S251120
Christopher S Ambrose, Bradley E Chipps, Wendy C Moore, Weily Soong, Jennifer Trevor, Dennis K Ledford, Warner W Carr, Njira Lugogo, Frank Trudo, Trung N Tran, Reynold A Panettieri

Background: Approximately 5-10% of patients with asthma have severe disease. High-quality real-world studies are needed to identify areas for improved management.

Objective: Aligned with the International Severe Asthma Registry, the CHRONICLE study (ClinicalTrials.gov: NCT03373045) was developed to address this need in the US.

Study design: Learnings from prior studies were applied to develop a real-world, prospective, noninterventional study of US patients with confirmed severe asthma who are treated by subspecialist physicians and require biologic or maintenance systemic immunosuppressant therapy or who are uncontrolled by high-dosage inhaled corticosteroids and additional controllers. Target enrollment is 4000 patients, with patient observation for ≥3 years. A geographically diverse sample of allergist/immunologist and pulmonologist sites approach all eligible patients under their care and report patient characteristics, treatment, and health outcomes every 6 months. Patients complete online surveys every 1-6 months.

Initial results: From February 2018 to February 2019, 102 sites screened 1428 eligible patients; 936 patients enrolled. Study sites (40% allergist/immunologist, 42% pulmonologist, 18% both) were similar to other US asthma subspecialist samples. Enrolled patients were 67% female with median ages at enrollment and diagnosis of 55 (range: 18-89) and 26 (0-80) years, respectively. Median body mass index was 31 kg/m2; 3% and 29% were current or former smokers, respectively, and >60% reported ≥1 exacerbation in the prior year and suboptimal symptom control.

Conclusion: CHRONICLE will provide high-quality provider- and patient-reported data from a large, real-world cohort of US adults with subspecialist-treated severe asthma.

背景:约有 5-10% 的哮喘患者病情严重。需要进行高质量的真实世界研究,以确定需要改进管理的领域:与国际严重哮喘登记处保持一致,CHRONICLE 研究(ClinicalTrials.gov: NCT03373045)旨在满足美国的这一需求:研究设计:从之前的研究中汲取经验,针对美国确诊重症哮喘患者开展一项真实世界、前瞻性、非介入性研究,这些患者接受亚专科医生治疗,需要生物制剂或维持性全身免疫抑制剂治疗,或使用大剂量吸入皮质类固醇和其他控制剂仍无法控制病情。目标是招募 4000 名患者,观察期≥3 年。过敏症/免疫科医生和肺科医生会在不同的地理位置抽取样本,与他们护理的所有符合条件的患者接触,每 6 个月报告一次患者特征、治疗情况和健康结果。患者每 1-6 个月完成一次在线调查:从 2018 年 2 月到 2019 年 2 月,102 个研究点筛选了 1428 名符合条件的患者;936 名患者注册。研究地点(40% 为过敏/免疫科医生,42% 为肺科医生,18% 两者皆有)与美国其他哮喘亚专科样本相似。入组患者中 67% 为女性,入组和确诊时的中位年龄分别为 55 岁(18-89 岁)和 26 岁(0-80 岁)。体重指数中位数为 31 kg/m2;目前或曾经吸烟的患者分别占 3% 和 29%,超过 60% 的患者在过去一年中病情恶化≥1 次,症状控制不理想:CHRONICLE将提供由医疗服务提供者和患者报告的高质量数据,这些数据来自于一个大型的、真实世界的美国成年重症哮喘患者队列。
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引用次数: 0
CPAP Therapeutic Options for Obstructive Sleep Apnea. 阻塞性睡眠呼吸暂停的CPAP治疗选择。
IF 8.9 Q2 MEDICINE, GENERAL & INTERNAL Pub Date : 2020-07-13 eCollection Date: 2020-01-01 DOI: 10.2147/POR.S258632
Robert G Hooper

Introduction: There are many options available to patients who are placed on constant positive airway pressure (CPAP) for obstructive sleep apnea. Despite the success of CPAP in correcting apnea, a significant number of patients have difficulty with the therapy. A large number of those patients who have difficulty stop therapy and are often labeled as "CPAP Failure". Non-sleep specialists may view CPAP therapy as a singular course of treatment, but there are many ways CPAP may be ordered for a patient. Each patient experiences a unique set of options that constitute a unique order set.

Methods: In order to demonstrate the magnitude of the possible options, estimates of the number of unique order sets were calculated. The author chose individual order options and the number of selections possible within each option. The calculated sets included a "Generous, Limited and Minimal" number of selections for each option. Calculations were done separately for standard CPAP and for auto-adjusting CPAP. Additional calculations were performed using the number of commercially available masks in the United States.

Results: The maximum number of unique order sets was seen using a standard CPAP combined with commercially available masks: 49,152 unique order sets. The fewest number of unique order sets were seen with the auto-adjusting CPAP and the "Minimal" selections: 288 unique order sets.

Discussion: There are a large number of unique CPAP orders that a patient may experience. CPAP treatment is not a singular or simple therapy. When evaluating obstructive sleep apnea patients with histories of CPAP failure or prior difficulty with CPAP, paying close attention to the patient's treatment experiences may help explain a significant number of those patients' CPAP therapy problems.

导读:阻塞性睡眠呼吸暂停患者采用持续气道正压通气(CPAP)治疗有多种选择。尽管CPAP在纠正呼吸暂停方面取得了成功,但仍有相当数量的患者难以接受该治疗。大量有困难的患者停止治疗,通常被标记为“CPAP失败”。非睡眠专家可能认为CPAP治疗是一个单一的治疗过程,但有许多方法可以为患者订购CPAP。每个病人都经历了一组独特的选择,这些选择构成了一个独特的顺序集。方法:为了证明可能的选项的大小,估计的唯一订单集的数量进行了计算。作者选择了单独的订单选项和选择的数量可能在每个选项。计算集包括每个选项的“慷慨,有限和最小”数量的选择。分别对标准CPAP和自动调节CPAP进行计算。使用美国市售口罩的数量进行了额外的计算。结果:使用标准CPAP与市售口罩相结合的最大唯一订单集数量:49152个唯一订单集。使用自动调节CPAP和“Minimal”选项可以看到最少数量的唯一订单集:288个唯一订单集。讨论:患者可能会遇到大量独特的CPAP医嘱。CPAP治疗不是单一或简单的治疗。在评估有CPAP失败史或既往CPAP治疗困难的阻塞性睡眠呼吸暂停患者时,密切关注患者的治疗经历可能有助于解释大量患者的CPAP治疗问题。
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引用次数: 4
Adequacy of Therapy for People with Both COPD and Heart Failure in the UK: Historical Cohort Study. 英国COPD和心力衰竭患者治疗的充分性:历史队列研究
IF 8.9 Q2 MEDICINE, GENERAL & INTERNAL Pub Date : 2020-06-02 eCollection Date: 2020-01-01 DOI: 10.2147/POR.S250451
Konstantinos Kostikas, Chin Kook Rhee, John R Hurst, Piergiuseppe Agostoni, Hui Cao, Robert Fogel, Rupert Jones, Janwillem W H Kocks, Karen Mezzi, Simon Wan Yau Ming, Ronan Ryan, David B Price

Purpose: Chronic obstructive pulmonary disease (COPD) and heart failure (HF) often occur concomitantly, presenting diagnostic and therapeutic challenges for clinicians. We examined the characteristics of patients prescribed adequate versus inadequate therapy within 3 months after newly diagnosed comorbid COPD or HF.

Patients and methods: Eligible patients in longitudinal UK electronic medical record databases had pre-existing HF and newly diagnosed COPD (2017 GOLD groups B/C/D) or pre-existing COPD and newly diagnosed HF. Adequate COPD therapy was defined as long-acting bronchodilator(s) with/without inhaled corticosteroid; adequate HF therapy was defined as beta-blocker plus angiotensin-converting enzyme inhibitor and/or angiotensin receptor blocker.

Results: Of 2439 patients with HF and newly diagnosed COPD (mean 75 years, 61% men), adequate COPD therapy was prescribed for 726 (30%) and inadequate for 1031 (42%); 682 (28%) remained untreated for COPD. Adequate (vs inadequate) COPD therapy was less likely for women (35%) than men (45%), smokers (36%) than ex-/non-smokers (45%), and non-obese (41%) than obese (47%); spirometry was recorded for 57% prescribed adequate versus 35% inadequate COPD therapy. Of 12,587 patients with COPD and newly diagnosed HF (mean 75 years, 60% men), adequate HF therapy was prescribed for 2251 (18%) and inadequate for 5332 (42%); 5004 (40%) remained untreated for HF. Adequate (vs inadequate) HF therapy was less likely for smokers (27%) than ex-/non-smokers (32%) and non-obese (30%) than obese (35%); spirometry was recorded for 65% prescribed adequate versus 39% inadequate HF therapy.

Conclusion: Many patients with comorbid COPD/HF receive inadequate therapy after new diagnosis. Improved equity of access to integrated care is needed for all patient subgroups.

目的:慢性阻塞性肺疾病(COPD)和心力衰竭(HF)经常同时发生,给临床医生的诊断和治疗带来了挑战。我们检查了新诊断为COPD或HF合并症的患者在3个月内接受适当治疗与不适当治疗的患者的特征。患者和方法:英国纵向电子病历数据库中符合条件的患者患有先前存在的HF和新诊断的COPD (2017 GOLD组B/C/D)或先前存在的COPD和新诊断的HF。适当的COPD治疗被定义为长效支气管扩张剂加/不加吸入皮质类固醇;适当的HF治疗被定义为β受体阻滞剂加血管紧张素转换酶抑制剂和/或血管紧张素受体阻滞剂。结果:2439例HF合并新诊断COPD患者(平均75岁,61%男性)中,726例(30%)接受了适当的COPD治疗,1031例(42%)接受了不适当的COPD治疗;682人(28%)仍未接受COPD治疗。女性(35%)比男性(45%),吸烟者(36%)比戒烟/不吸烟(45%),非肥胖(41%)比肥胖(47%)更不可能接受充分(vs不充分)的COPD治疗;肺量测定记录显示,57%的患者接受了适当的COPD治疗,35%的患者接受了不适当的COPD治疗。在12587例COPD合并新诊断HF患者(平均75岁,60%男性)中,2251例(18%)患者接受了适当的HF治疗,5332例(42%)患者接受了不适当的HF治疗;5004例(40%)仍未接受HF治疗。充分(vs不充分)心衰治疗对于吸烟者(27%)比戒烟/不吸烟(32%)和非肥胖(30%)比肥胖(35%)的可能性要小;65%的患者接受了适当的心力衰竭治疗,39%的患者接受了不适当的心力衰竭治疗。结论:许多合并COPD/HF的患者在新诊断后治疗不足。需要改善所有患者亚群获得综合护理的公平性。
{"title":"Adequacy of Therapy for People with Both COPD and Heart Failure in the UK: Historical Cohort Study.","authors":"Konstantinos Kostikas,&nbsp;Chin Kook Rhee,&nbsp;John R Hurst,&nbsp;Piergiuseppe Agostoni,&nbsp;Hui Cao,&nbsp;Robert Fogel,&nbsp;Rupert Jones,&nbsp;Janwillem W H Kocks,&nbsp;Karen Mezzi,&nbsp;Simon Wan Yau Ming,&nbsp;Ronan Ryan,&nbsp;David B Price","doi":"10.2147/POR.S250451","DOIUrl":"https://doi.org/10.2147/POR.S250451","url":null,"abstract":"<p><strong>Purpose: </strong>Chronic obstructive pulmonary disease (COPD) and heart failure (HF) often occur concomitantly, presenting diagnostic and therapeutic challenges for clinicians. We examined the characteristics of patients prescribed adequate versus inadequate therapy within 3 months after newly diagnosed comorbid COPD or HF.</p><p><strong>Patients and methods: </strong>Eligible patients in longitudinal UK electronic medical record databases had pre-existing HF and newly diagnosed COPD (2017 GOLD groups B/C/D) or pre-existing COPD and newly diagnosed HF. Adequate COPD therapy was defined as long-acting bronchodilator(s) with/without inhaled corticosteroid; adequate HF therapy was defined as beta-blocker plus angiotensin-converting enzyme inhibitor and/or angiotensin receptor blocker.</p><p><strong>Results: </strong>Of 2439 patients with HF and newly diagnosed COPD (mean 75 years, 61% men), adequate COPD therapy was prescribed for 726 (30%) and inadequate for 1031 (42%); 682 (28%) remained untreated for COPD. Adequate (vs inadequate) COPD therapy was less likely for women (35%) than men (45%), smokers (36%) than ex-/non-smokers (45%), and non-obese (41%) than obese (47%); spirometry was recorded for 57% prescribed adequate versus 35% inadequate COPD therapy. Of 12,587 patients with COPD and newly diagnosed HF (mean 75 years, 60% men), adequate HF therapy was prescribed for 2251 (18%) and inadequate for 5332 (42%); 5004 (40%) remained untreated for HF. Adequate (vs inadequate) HF therapy was less likely for smokers (27%) than ex-/non-smokers (32%) and non-obese (30%) than obese (35%); spirometry was recorded for 65% prescribed adequate versus 39% inadequate HF therapy.</p><p><strong>Conclusion: </strong>Many patients with comorbid COPD/HF receive inadequate therapy after new diagnosis. Improved equity of access to integrated care is needed for all patient subgroups.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"11 ","pages":"55-66"},"PeriodicalIF":8.9,"publicationDate":"2020-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S250451","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38086365","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 3
Real-World Safety and Effectiveness of Tadalafil in Patients with Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Japanese Post-Marketing Surveillance Study. 他达拉非治疗继发于良性前列腺增生的下尿路症状的安全性和有效性:一项日本上市后监测研究
IF 8.9 Q2 MEDICINE, GENERAL & INTERNAL Pub Date : 2020-05-04 eCollection Date: 2020-01-01 DOI: 10.2147/POR.S237821
Hiroyoshi Yamazaki, Naoto Tsujimoto, Momoha Koyanagi, Megumi C Katoh, Koyuki Tajima, Mika Komori

Objective: To evaluate the long-term safety and effectiveness of tadalafil in Japanese men with lower urinary tract symptoms secondary to benign prostatic hyperplasia in real-world clinical practice; and to investigate the safety profile in patients aged ≥75 years.

Patients and methods: This was a prospective, non-interventional, multicenter, post-marketing surveillance study in which Japanese patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia were observed for up to 18 months after initiating tadalafil treatment. The real-world safety and effectiveness outcomes were assessed at baseline and at 1, 3, 6, 12, and 18 months post-treatment or the last day of treatment.

Results: Most patients received tadalafil 5 mg per day throughout the observation period. Among 1393 patients analyzed for safety, the overall incidence of adverse drug reactions was 8.3%. These adverse drug reactions were generally consistent with the known safety profile of tadalafil and no new safety risks were identified in long-term use. There was no statistical difference in the frequency of adverse drug reactions between patients aged <75 and ≥75 years. The mean change in total International Prostate Symptom Score (IPSS) and IPSS-quality of life subscore was significantly improved at each timepoint. At 18 months, IPSS had improved by 5.0 points (P < 0.001) and IPSS-quality of life subscore had improved by 1.5 points (P < 0.001). The mean change in post-voiding residual urine volume from baseline was significant at each time point and was -9.8 mL at 18 months (P < 0.001); there were no significant differences from baseline in maximum urinary flow rate.

Conclusion: This surveillance demonstrated that tadalafil has favorable safety and effectiveness profiles for long-term use in Japanese men with lower urinary tract symptoms secondary to benign prostatic hyperplasia. In addition, safety profiles in patients aged ≥75 years were similar to patients aged <75 years.

目的:评价他达拉非治疗日本男性良性前列腺增生继发下尿路症状的长期安全性和有效性;并调查≥75岁患者的安全性。患者和方法:这是一项前瞻性、非介入性、多中心、上市后监测研究,在开始他达拉非治疗后长达18个月的时间里,观察了日本患者继发于良性前列腺增生的下尿路症状。真实世界的安全性和有效性结果在基线和治疗后1、3、6、12和18个月或治疗最后一天进行评估。结果:大部分患者在整个观察期内给予他达拉非5mg / d。在1393例安全性分析患者中,药物不良反应的总发生率为8.3%。这些药物不良反应与他达拉非已知的安全性基本一致,长期使用未发现新的安全风险。两组患者药物不良反应发生频率差异无统计学意义(P < 0.001), IPSS-quality life评分提高1.5分(P < 0.001)。排尿后残余尿量与基线相比在每个时间点的平均变化都很显著,在18个月时为-9.8 mL (P < 0.001);最大尿流率与基线无显著差异。结论:这项监测表明,他达拉非在日本男性良性前列腺增生继发的下尿路症状中长期使用具有良好的安全性和有效性。此外,≥75岁患者的安全性与老年患者相似
{"title":"Real-World Safety and Effectiveness of Tadalafil in Patients with Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Japanese Post-Marketing Surveillance Study.","authors":"Hiroyoshi Yamazaki,&nbsp;Naoto Tsujimoto,&nbsp;Momoha Koyanagi,&nbsp;Megumi C Katoh,&nbsp;Koyuki Tajima,&nbsp;Mika Komori","doi":"10.2147/POR.S237821","DOIUrl":"https://doi.org/10.2147/POR.S237821","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the long-term safety and effectiveness of tadalafil in Japanese men with lower urinary tract symptoms secondary to benign prostatic hyperplasia in real-world clinical practice; and to investigate the safety profile in patients aged ≥75 years.</p><p><strong>Patients and methods: </strong>This was a prospective, non-interventional, multicenter, post-marketing surveillance study in which Japanese patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia were observed for up to 18 months after initiating tadalafil treatment. The real-world safety and effectiveness outcomes were assessed at baseline and at 1, 3, 6, 12, and 18 months post-treatment or the last day of treatment.</p><p><strong>Results: </strong>Most patients received tadalafil 5 mg per day throughout the observation period. Among 1393 patients analyzed for safety, the overall incidence of adverse drug reactions was 8.3%. These adverse drug reactions were generally consistent with the known safety profile of tadalafil and no new safety risks were identified in long-term use. There was no statistical difference in the frequency of adverse drug reactions between patients aged <75 and ≥75 years. The mean change in total International Prostate Symptom Score (IPSS) and IPSS-quality of life subscore was significantly improved at each timepoint. At 18 months, IPSS had improved by 5.0 points (<i>P</i> < 0.001) and IPSS-quality of life subscore had improved by 1.5 points (<i>P</i> < 0.001). The mean change in post-voiding residual urine volume from baseline was significant at each time point and was -9.8 mL at 18 months (<i>P</i> < 0.001); there were no significant differences from baseline in maximum urinary flow rate.</p><p><strong>Conclusion: </strong>This surveillance demonstrated that tadalafil has favorable safety and effectiveness profiles for long-term use in Japanese men with lower urinary tract symptoms secondary to benign prostatic hyperplasia. In addition, safety profiles in patients aged ≥75 years were similar to patients aged <75 years.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"11 ","pages":"45-54"},"PeriodicalIF":8.9,"publicationDate":"2020-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S237821","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37964248","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
Reliability of Conclusions from Early Analyses of Real-World Data for Newly Approved Drugs in Advanced Gastric Cancer in the United States. 美国新近批准的晚期胃癌药物的真实世界数据早期分析结论的可靠性
IF 8.9 Q2 MEDICINE, GENERAL & INTERNAL Pub Date : 2020-04-30 eCollection Date: 2020-01-01 DOI: 10.2147/POR.S241427
Lisa M Hess, Michael Grabner, Liya Wang, Astra M Liepa, Xiaohong Ivy Li, Zhanglin Lin Cui, Lee Bowman, William R Schelman

Background: As real-world data resources expand and improve, there will increasingly be opportunities to study the effectiveness of interventions. There is a need to ensure that study designs explore potential sources of bias and either acknowledge or mitigate them, in order to improve the accuracy of findings. The objective of this study was to understand newly approved drug utilization patterns in real-world clinical settings over time.

Methods: This retrospective study included three sources of real-world data (claims, electronic health records, and recoded data from a quality care program) collected from patients diagnosed with gastric cancer who initiated therapy with either trastuzumab or ramucirumab. Linear regression was used to investigate trends in the use of these drugs for the care of patients with gastric cancer over time from Food and Drug Administration (FDA) approval.

Results: Eligible patients (n=1700) had consistent demographic and clinical characteristics over time. After regulatory approval, trastuzumab was used in later lines of therapy and then shifted to earlier lines (p=0.002), while ramucirumab utilization remained consistent over time after FDA approval (p=0.49). Ramucirumab augmentation, defined as the addition of the drug after initiation of a line of therapy, decreased over time (p=0.03), and trastuzumab augmentation remained consistent over time (p=0.58).

Conclusion: Since treatment effectiveness may change across lines of treatment, bias may arise if there are changes in the use of the drug (such as line migration) during the time period of analysis using real-world data.

背景:随着现实世界数据资源的扩展和完善,将有越来越多的机会研究干预措施的有效性。有必要确保研究设计探索潜在的偏见来源,并承认或减轻它们,以提高研究结果的准确性。本研究的目的是了解新批准的药物使用模式,在现实世界的临床设置随着时间的推移。方法:这项回顾性研究包括三个真实数据来源(索赔、电子健康记录和质量护理计划的重新编码数据),这些数据来自于曲妥珠单抗或拉穆单抗治疗的胃癌患者。线性回归用于调查自美国食品和药物管理局(FDA)批准以来这些药物用于胃癌患者护理的趋势。结果:符合条件的患者(n=1700)随时间的推移具有一致的人口统计学和临床特征。在获得监管批准后,曲妥珠单抗被用于较晚的治疗线,然后转移到较早的治疗线(p=0.002),而在FDA批准后,ramucirumab的使用一直保持一致(p=0.49)。Ramucirumab增强,定义为在开始一系列治疗后添加药物,随着时间的推移而减少(p=0.03),而曲妥珠单抗增强随时间保持一致(p=0.58)。结论:由于治疗效果可能在治疗线之间发生变化,如果在使用真实数据分析的时间段内药物使用发生变化(如线迁移),则可能产生偏倚。
{"title":"Reliability of Conclusions from Early Analyses of Real-World Data for Newly Approved Drugs in Advanced Gastric Cancer in the United States.","authors":"Lisa M Hess,&nbsp;Michael Grabner,&nbsp;Liya Wang,&nbsp;Astra M Liepa,&nbsp;Xiaohong Ivy Li,&nbsp;Zhanglin Lin Cui,&nbsp;Lee Bowman,&nbsp;William R Schelman","doi":"10.2147/POR.S241427","DOIUrl":"https://doi.org/10.2147/POR.S241427","url":null,"abstract":"<p><strong>Background: </strong>As real-world data resources expand and improve, there will increasingly be opportunities to study the effectiveness of interventions. There is a need to ensure that study designs explore potential sources of bias and either acknowledge or mitigate them, in order to improve the accuracy of findings. The objective of this study was to understand newly approved drug utilization patterns in real-world clinical settings over time.</p><p><strong>Methods: </strong>This retrospective study included three sources of real-world data (claims, electronic health records, and recoded data from a quality care program) collected from patients diagnosed with gastric cancer who initiated therapy with either trastuzumab or ramucirumab. Linear regression was used to investigate trends in the use of these drugs for the care of patients with gastric cancer over time from Food and Drug Administration (FDA) approval.</p><p><strong>Results: </strong>Eligible patients (n=1700) had consistent demographic and clinical characteristics over time. After regulatory approval, trastuzumab was used in later lines of therapy and then shifted to earlier lines (p=0.002), while ramucirumab utilization remained consistent over time after FDA approval (p=0.49). Ramucirumab augmentation, defined as the addition of the drug after initiation of a line of therapy, decreased over time (p=0.03), and trastuzumab augmentation remained consistent over time (p=0.58).</p><p><strong>Conclusion: </strong>Since treatment effectiveness may change across lines of treatment, bias may arise if there are changes in the use of the drug (such as line migration) during the time period of analysis using real-world data.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"11 ","pages":"27-43"},"PeriodicalIF":8.9,"publicationDate":"2020-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S241427","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37955045","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
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