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Real-Life Effectiveness of MP-AzeFlu (Dymista®) in Swedish Patients with Persistent Allergic Rhinitis, Assessed by the Visual Analogue Scale. MP-AzeFlu (Dymista®)在瑞典持续性变应性鼻炎患者中的实际疗效:通过视觉模拟量表评估
IF 8.9 Pub Date : 2023-01-01 DOI: 10.2147/POR.S375403
Pär Stjärne, Duc Tung Nguyen, Hans Christian Kuhl

Background: Many allergic rhinitis (AR) patients have moderate/severe persistent disease. MP-AzeFlu (Dymista®) comprises intranasal azelastine hydrochloride and fluticasone propionate in a novel formulation delivered in a single device.

Objective: This prospective, noninterventional study assessed the effectiveness of MP-AzeFlu (one spray/nostril twice daily; azelastine hydrochloride = 548 μg; fluticasone propionate = 200 μg) on relieving AR symptom severity.

Methods: A visual analogue scale (VAS; 0 mm [not at all bothersome] to 100 mm [very bothersome]) was used during a 42-day MP-AzeFlu treatment period by 161 persistent AR (PER) patients in routine clinical practice in Sweden. Patients also assessed their sleep quality.

Results: VAS scores decreased from baseline during the treatment period and patients achieved a clinically relevant VAS score cutoff before Day 7, with 89.3% reporting well or partly controlled symptoms on Day 1. VAS score decreased from 61.4 ± 22.4 mm (baseline) to 32.1 ± 24.6 mm on Day 28 and 26.1 ± 24.3 mm on Day 42 (both p < 0.0001), an overall reduction from baseline on Day 42 of 38.1 ± 28.2 mm. The percentage of patients with very good/good sleep quality increased from 3.7%/28.6% on Day 0 to 16.5%/51.5% on Day 42.

Conclusion: MP-AzeFlu provides effective, rapid control of PER assessed by VAS in a real-world clinical setting in Sweden. Symptom improvement was observed at Day 1, sustained for 42 days, and associated with improved sleep quality. MP-AzeFlu significantly improved the QoL of the patients and was well tolerated.

背景:许多变应性鼻炎(AR)患者具有中/重度持续性疾病。MP-AzeFlu (Dymista®)由鼻用盐酸氮唑elastine和丙酸氟替卡松组成,是一种通过单一装置递送的新型制剂。目的:这项前瞻性、非介入性研究评估了MP-AzeFlu的有效性(每日两次,每次喷鼻;盐酸氮扎elastine = 548 μg;丙酸氟替卡松= 200 μg)缓解AR症状严重程度。方法:采用视觉模拟量表(VAS);在瑞典的常规临床实践中,161名持续性AR (PER)患者在42天的MP-AzeFlu治疗期间使用了0毫米[完全不麻烦]到100毫米[非常麻烦])。患者还评估了他们的睡眠质量。结果:VAS评分在治疗期间较基线下降,患者在第7天之前达到临床相关的VAS评分截止点,89.3%的患者在第1天报告症状良好或部分控制。VAS评分从61.4±22.4 mm(基线)下降到第28天的32.1±24.6 mm和第42天的26.1±24.3 mm(均p < 0.0001),从第42天的基线总体下降38.1±28.2 mm。非常好/良好睡眠质量的患者比例从第0天的3.7%/28.6%上升到第42天的16.5%/51.5%。结论:MP-AzeFlu在瑞典的现实世界临床环境中提供了有效、快速的PER控制。第1天观察到症状改善,持续42天,并与睡眠质量改善相关。MP-AzeFlu显著改善了患者的生活质量,且耐受性良好。
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引用次数: 0
Impact of the COVID-19 Pandemic on Trauma Service Utilization at a New York City Level I Trauma Center. COVID-19大流行对纽约市一级创伤中心创伤服务利用的影响
IF 8.9 Pub Date : 2022-09-05 eCollection Date: 2022-01-01 DOI: 10.2147/POR.S378189
Benjamin Rosen, Annemarie L Pelle, Nisha A Lakhi

Background: The COVID-19 pandemic globally impacted trauma facilities and overall healthcare utilization. This study was conducted to characterize the utilization of trauma services at our Level I Trauma Center in New York City during the COVID-19 pandemic compared to the preceding pre-pandemic year.

Methods: A retrospective study of patient presenting to our Level 1 Trauma Center in Staten Island, New York. The pre-pandemic data was extracted from March 1st, 2019-February 29th, 2020. The pandemic year was divided into two phases: the initial wave (March 1st-Sept 1st, 2020) and the protracted phase (September 1st, 2020-March 1st, 2021). Patients were identified using ICD-10 coding and data regarding patient factors, mechanism of injury, and service utilization was extracted from the medical record. Statistical analysis was performed using IBM SPSS v.24.

Results: A total of 1650 trauma activations registered during the pre-pandemic phase, 691 during the initial wave, and 826 during the protracted phase. Compared to pre-pandemic, the number of Level 1 trauma activations remained unchanged, however mechanisms of injury shifted. Gunshot wounds (2.6% vs 1.2%), motorcycle crash (4.2% vs 2.0%) and blunt force injury caused by an object (strike injuries) (2.7% vs 1.3%) significantly increased during the initial wave (p-value <0.05). There was a significant decrease in the percentage of both female (2.93% vs 2.33% vs 5.64%, p-value <0.01) and pediatric (3.30% vs 3.64% vs 12.9%, p-value <0.001) assault activations during the initial wave and protracted phase when compared to pre-pandemic levels, respectively. No significant changes were observed for self-harm, falls, accidents, burns, sports injuries, stab wounds, autobody collisions, or motor vehicle accident activations.

Conclusion: Trauma centers should be prepared for increases in violent trauma. We also emphasize the need to implement strategies to raise public awareness of pediatric and female assault in the domestic setting, particularly during a mandatory stay-at-home policy where underreporting may occur.

背景:COVID-19大流行影响了全球创伤设施和整体医疗保健利用率。本研究旨在描述在2019冠状病毒病大流行期间,与前一年相比,我们纽约市一级创伤中心对创伤服务的利用情况。方法:对在纽约史泰登岛一级创伤中心就诊的患者进行回顾性研究。大流行前数据提取于2019年3月1日至2020年2月29日。大流行年分为两个阶段:初始阶段(2020年3月1日至9月1日)和延长阶段(2020年9月1日至2021年3月1日)。使用ICD-10编码对患者进行识别,并从病历中提取有关患者因素、损伤机制和服务利用的数据。采用IBM SPSS v.24进行统计学分析。结果:在大流行前阶段共记录了1650例创伤激活,在初始波期间记录了691例,在延长阶段记录了826例。与大流行前相比,1级创伤激活的数量保持不变,但损伤机制发生了变化。枪伤(2.6% vs 1.2%)、摩托车碰撞(4.2% vs 2.0%)和由物体造成的钝器伤(撞击伤)(2.7% vs 1.3%)在初始波期间显著增加(p值)。结论:创伤中心应为暴力创伤的增加做好准备。我们还强调有必要实施战略,提高公众对家庭环境中儿童和女性遭受侵犯的认识,特别是在强制性居家政策期间,可能会发生漏报。
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引用次数: 1
Detection of Short-Term Side Effects of ChAdOx1 nCoV-19 Vaccine: A Cross-Sectional Study in a War-Torn Country. ChAdOx1 nCoV-19疫苗的短期副作用检测:在一个饱受战争蹂躏的国家进行的横断面研究
IF 8.9 Pub Date : 2022-08-25 eCollection Date: 2022-01-01 DOI: 10.2147/POR.S381836
Mohammed Alshakka, Najmaddin A H Hatem, Wafa Badullah, Rabab Alsakaf, Ali Rageh, Seena Abdulla Yousef, Mohamed Izham Mohamed Ibrahim

Purpose: The chAdOx1 nCoV-19 vaccine is the first COVID-19 vaccine available in Yemen. Hence, this local-based study was used to identify the type and frequency of short-term side effects following 48 hours of the first shot of the vaccine.

Methods: A cross-section of vaccinated participants in Aden were surveyed by telephone. Descriptive statistics were used for statistical analysis.

Results: A total of 500 participants were included through convenient sampling. 27% of them were health care providers. Nearly 70% of the respondent experienced side effects. The top three side effects reported were fever (n=276, 55.2%), myalgia (n=270, 54%) and fatigue (n=247, 49.4%). Generally, most participants stated that they experienced the side effects after the first 24 hours of vaccination.

Conclusion: Side effects that participants experienced were not different from the literature, indicating a safe profile for the vaccine. Further studies are needed to identify the side effects after the second and third dose of the vaccine. In addition, more studies are required to assess the efficacy of the existing vaccines against new variants.

目的:chAdOx1 nCoV-19疫苗是也门首个可用的COVID-19疫苗。因此,这项以当地为基础的研究用于确定首次接种疫苗48小时后短期副作用的类型和频率。方法:通过电话对亚丁接种疫苗的参与者进行横断面调查。采用描述性统计方法进行统计分析。结果:通过方便抽样,共纳入500人。其中27%是卫生保健提供者。近70%的受访者出现了副作用。报告的前三位副作用分别是发热(276例,55.2%)、肌痛(270例,54%)和疲劳(247例,49.4%)。一般来说,大多数参与者表示他们在接种疫苗的第一个24小时后经历了副作用。结论:参与者所经历的副作用与文献没有不同,表明疫苗是安全的。需要进一步研究以确定接种第二剂和第三剂疫苗后的副作用。此外,需要更多的研究来评估现有疫苗对新变种的有效性。
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引用次数: 1
A Phase IV Study on Safety, Tolerability and Efficacy of Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate in Treatment Naïve Adult Indian Patients Living with HIV-1. Dolutegravir, Lamivudine和Tenofovir Disoproxil Fumarate治疗Naïve印度成年HIV-1患者的安全性,耐受性和有效性的IV期研究
IF 8.9 Pub Date : 2022-08-10 eCollection Date: 2022-01-01 DOI: 10.2147/POR.S361907
Ameet Dravid, Dnyanesh Morkar, Dwijendra Prasad, John T Ramapuram, Kartik Vikrambhai Patel, K Sunil Naik, Milind Bhrusundi, Milind Kulkarni, Sanjeev Hegde, S Anuradha, Siddabathuni Nageswaramma, Surabhi Madan, Thammisetty Jayaprakash, Vinay Kulkarni

Purpose: WHO recommends dolutegravir (DTG) based regimens as first-line treatment for HIV-1 infection. However, few studies have been conducted in Indian population. Hence, our study evaluated the safety, tolerability, and efficacy of DTG 50 mg with Tenofovir and Lamivudine (300/300mg) fixed dose combination in treatment naïve adult Indian patients.

Methods: This was an open label, multicenter, prospective, interventional, phase IV study conducted across 14 sites between February 2019 and July 2020. 24 weeks was the treatment duration for each subject. The primary end point was to assess the incidence of adverse events (AEs) and secondary end points were to assess the proportion of patients achieving plasma HIV-1 RNA levels <50 copies/mL at week 24 and change in CD4+ cell count from the baseline. Safety analysis was conducted using Safety Analysis Set and efficacy analysis was carried out using Full Analysis Set and Per protocol set.

Results: A total of 288 patients were screened; 250 were enrolled; and 229 completed the study. 389 AEs were reported from 58% of patients. Of these, 61 were related to study treatment. One event of decreased creatinine clearance led to study discontinuation. One serious event of pyrexia was reported, which was unrelated to the study drug. The most common AEs were headache (18%), pyrexia (14%), vomiting (6.4%) and upper respiratory tract infections (6%). No deaths were reported. At week 24, 86.8% of the patients achieved plasma HIV-1 RNA levels <50 copies/mL and the mean CD4 cell count increased from 350.2 (SD, 239.73) at baseline to 494.6 (SD, 261.40) with an average increase of 143.2 (SD, 226.14) cells.

Conclusion: This study demonstrated the safety and efficacy of DTG based regimen in treatment naïve HIV-1 patients in Indian population and support use of DTG as first-line treatment regimen.

目的:世卫组织推荐以多替重力韦(DTG)为基础的方案作为HIV-1感染的一线治疗。然而,在印度人群中进行的研究很少。因此,我们的研究评估了DTG 50 mg与替诺福韦和拉米夫定(300/300mg)固定剂量联合治疗naïve成年印度患者的安全性、耐受性和有效性。方法:这是一项开放标签、多中心、前瞻性、介入性、IV期研究,于2019年2月至2020年7月在14个地点进行。每名受试者的治疗时间为24周。主要终点是评估不良事件(ae)的发生率,次要终点是评估达到血浆HIV-1 RNA水平的患者比例。结果:共筛查288例患者;250人入选;229人完成了这项研究。58%的患者报告了389例ae。其中,61例与研究治疗有关。一例肌酐清除率降低导致研究中止。报告了一例与研究药物无关的严重发热事件。最常见的ae是头痛(18%)、发热(14%)、呕吐(6.4%)和上呼吸道感染(6%)。没有死亡报告。结论:本研究证明了以DTG为基础的方案治疗naïve印度人群中HIV-1患者的安全性和有效性,并支持将DTG作为一线治疗方案。
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引用次数: 0
The Preferences of Modes of Child Delivery and Associated Factors Among Pregnant Women in Southern Ethiopia. 埃塞俄比亚南部孕妇分娩方式偏好及相关因素
IF 8.9 Pub Date : 2022-07-15 eCollection Date: 2022-01-01 DOI: 10.2147/POR.S370513
Bewunetu Zewude, Getahun Siraw, Yesuf Adem
Background The purpose of the study was to identify the choice of mode of delivery and the factors associated with such preferences among pregnant women attending antenatal care services in Southern Ethiopia. Methods Using an institutional-based cross-sectional survey, quantitative data were collected from randomly selected pregnant women in Southern Ethiopia. A semi-structured questionnaire was distributed to pregnant women who had been attending antenatal healthcare services in purposively selected public and private healthcare facilities in Shashemene town. The completed cases were inserted into SPSS version 26 in which both descriptive and inferential statistical techniques were used to analyze the data. Results It was found that 75.4% of respondents replied that they prefer vaginal delivery while 24.6% had chosen cesarean section. Personal conviction motivated by the need to experience the labor process, the belief in it being a natural method, the perception that it is better for the wellbeing of both the mother and the child, previous experience of delivery by vaginal method, fear or the need to avoid episiotomy, and economic concerns have been mentioned as reasons for the choice of vaginal delivery. Moreover, respondents’ choice of the mode of delivery is significantly associated with religion, age, number of children, pregnancy experience, previous mode of delivery, self-rated social class status, autonomy to decide about mode of delivery, and type of healthcare organization of antenatal care attendance. Conclusion Although vaginal delivery has remained the most preferred mode of delivery among most pregnant women, about a quarter of pregnant women have reported that they prefer to deliver by cesarean section, a prevalence rate which is higher than the national average, indicating that the choice of cesarean section is still increasing among women.
背景:本研究的目的是确定在埃塞俄比亚南部参加产前保健服务的孕妇中分娩方式的选择以及与这种偏好相关的因素。方法:采用基于机构的横断面调查,从埃塞俄比亚南部随机选择的孕妇中收集定量数据。向在沙舍梅内镇选定的公立和私立医疗机构接受产前保健服务的孕妇分发了一份半结构化问卷。完成的病例被插入到SPSS版本26中,其中描述性和推断性统计技术被用来分析数据。结果:75.4%的受访者选择阴道分娩,24.6%的受访者选择剖宫产。由于需要体验分娩过程,相信这是一种自然的方法,认为这对母亲和孩子的幸福都更好,以前通过阴道分娩的经验,害怕或需要避免外阴切开术,以及经济方面的考虑,都被提到作为选择阴道分娩的原因。此外,受访者对分娩方式的选择与宗教信仰、年龄、子女数量、怀孕经历、以往分娩方式、自评社会阶层地位、自主决定分娩方式和产前护理机构类型显著相关。结论:虽然阴道分娩仍然是大多数孕妇的首选分娩方式,但约有四分之一的孕妇报告更倾向于剖宫产,患病率高于全国平均水平,表明女性选择剖宫产的比例仍在增加。
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引用次数: 0
Characterisation of the Australian Adult Population Living with Asthma: Severe - Exacerbation Frequency, Long-Term OCS Use and Adverse Effects. 澳大利亚成年哮喘患者的特征:严重发作频率、长期使用OCS和不良反应。
IF 8.9 Pub Date : 2022-07-05 eCollection Date: 2022-01-01 DOI: 10.2147/POR.S360044
Kerry L Hancock, Sinthia Bosnic-Anticevich, John D Blakey, Mark Hew, Li Ping Chung, Biljana Cvetkovski, Scott Claxton, Peter Del Fante, Eve Denton, Joe Doan, Kanchanamala Ranasinghe, Lucy Morgan, Anita Sharma, Peter K Smith, Deb Stewart, Philip J Thompson, Russell Wiseman, John W Upham, Kwok Y Yan, Victoria Carter, Kiranjeet Dhillon, Florian Heraud, Thao Le, Rebecca Vella, David Price

Introduction: Asthma poses a significant burden for the Australian population. Understanding severe exacerbation rates, and steroid-related burden for adults diagnosed with asthma stands to offer insights into how this could be reduced.

Methods: Electronic medical records (EMR) and questionnaires from the Optimum Patient Care Research Database Australia (OPCRDA) were utilised retrospectively. OPCRDA is a real-world database with >800,000 medical records from Australian primary care practices. Outcomes were severe asthma exacerbations in Australian adults, over a 12-month period, stratified by Global Initiative for Asthma (GINA) treatment intensity steps, and steroid associated comorbidities.

Results: Of the 7868 adults treated for asthma, 19% experienced at least one severe exacerbation in the last 12-months. Severe exacerbation frequency increased with treatment intensity (≥1 severe exacerbation GINA 1 13%; GINA 4 23%; GINA 5a 33% and GINA 5b 28%). Questionnaire participants reported higher rates of severe exacerbations than suggested from their EMR (32% vs 23%) especially in steps 1, 4 and 5. Patients repeatedly exposed to steroids had an increased risk of osteoporosis (OR 1.95, 95% CI 1.43-2.66) and sleep apnoea (OR 1.78, 95% CI 1.30-2.46).

Conclusion: The Australian population living with GINA 1, 4, 5a and 5b asthma have high severe exacerbation rates and steroid-related burden, especially when compared to other first world countries, with these patients needing alternative strategies or possibly specialist assessment to better manage their condition.

简介:哮喘是澳大利亚人口的一个重大负担。了解严重恶化率和成人诊断哮喘的类固醇相关负担,将为如何减少这种情况提供见解。方法:回顾性使用澳大利亚最佳患者护理研究数据库(OPCRDA)的电子病历(EMR)和问卷调查。OPCRDA是一个真实世界的数据库,拥有来自澳大利亚初级保健实践的超过80万份医疗记录。结果是澳大利亚成年人在12个月的时间内严重哮喘恶化,按全球哮喘倡议(GINA)治疗强度步骤和类固醇相关合并症分层。结果:在7868名接受哮喘治疗的成年人中,19%在过去12个月内至少经历过一次严重恶化。严重加重频率随治疗强度增加而增加(≥1次严重加重GINA 1 13%;吉娜4 23%;GINA 5a 33%, GINA 5b 28%)。问卷参与者报告的严重恶化率高于EMR (32% vs 23%),特别是在步骤1、4和5中。反复暴露于类固醇的患者骨质疏松症(OR 1.95, 95% CI 1.43-2.66)和睡眠呼吸暂停(OR 1.78, 95% CI 1.30-2.46)的风险增加。结论:与其他第一世界国家相比,澳大利亚GINA 1、4、5a和5b哮喘患者有较高的严重加重率和类固醇相关负担,这些患者需要替代策略或可能的专家评估来更好地管理他们的病情。
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引用次数: 3
Real-World Experience with Favipiravir for the Treatment of Mild-to-Moderate COVID-19 in India. Favipiravir治疗印度中轻度新冠肺炎的现实世界经验
IF 8.9 Pub Date : 2022-05-27 eCollection Date: 2022-01-01 DOI: 10.2147/POR.S364066
Shashank Joshi, Agam Vora, K Venugopal, Pramod Dadhich, Anil Daxini, Sagar Bhagat, Saiprasad Patil, Hanmant Barkate

Background: Favipiravir, an RNA-dependent RNA polymerase inhibitor (RdRp), is a broad-spectrum oral antiviral agent approved in India under emergency use authorization, for the treatment of mild-to-moderate coronavirus disease (COVID-19). The present study was planned to evaluate the effectiveness and safety of favipiravir in real-world clinical practice.

Materials and methods: This was a multicentric, retrospective, single-arm study conducted across four centres in India, after obtaining permission from the independent ethics committee. Medical records were analysed to evaluate effectiveness and safety of patients who were prescribed favipiravir.

Results: The medical records of a total of 360 patients met the inclusion criteria, with 358 of them available for the final analysis. Males made up 58.46% of the study population. The average age of enrolled patients was 51.80 ± 16.45 years. The most common symptoms were fever, cough, and myalgia-fatigue. The median time to clinical cure and fever relief was five and four days, respectively. The average length of stay in the hospital was six days. In total, 8% of the patients experienced adverse events. Hepatic enzyme elevation, diarrhoea, decreased appetite, headache, fatigue, and giddiness were the common symptoms.

Conclusion: In our real-world study, favipiravir was found to have a clinical cure rate of more than 90% in mild-to-moderate COVID-19 patients. This supports the use of favipiravir in the treatment of COVID-19. Favipiravir was well tolerated, with only minimal side effects, which were transient in nature.

Favipiravir是一种RNA依赖性RNA聚合酶抑制剂(RdRp),是一种广谱口服抗病毒药物,在印度获得紧急使用授权,用于治疗轻中度冠状病毒病(COVID-19)。本研究旨在评估法匹拉韦在实际临床实践中的有效性和安全性。材料和方法这是一项多中心、回顾性、单臂研究,在获得独立伦理委员会的许可后,在印度的四个中心进行。分析医疗记录以评价处方法匹拉韦患者的有效性和安全性。结果共有360例患者的病历符合纳入标准,其中358例可供最终分析。男性占研究人群的58.46%。入组患者平均年龄为51.80±16.45岁。最常见的症状是发烧、咳嗽和肌痛-疲劳。临床治愈和发热缓解的中位时间分别为5天和4天。平均住院时间为6天。总的来说,8%的患者出现了不良事件。肝酶升高、腹泻、食欲下降、头痛、疲劳和头晕是常见症状。在我们的现实世界研究中,发现favipiravir对轻至中度COVID-19患者的临床治愈率超过90%。这支持使用法匹拉韦治疗COVID-19。Favipiravir耐受性良好,副作用很小,而且是短暂的。
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引用次数: 3
Variation in Demographic and Clinical Characteristics of Patients with COPD Receiving Care in US Primary Care: Data from the Advancing the Patient EXperience (APEX) in COPD Registry 在美国接受初级保健治疗的COPD患者的人口统计学和临床特征的变化:来自COPD登记处推进患者体验(APEX)的数据
IF 8.9 Pub Date : 2022-04-01 DOI: 10.2147/POR.S342736
C. Fox, W. Pace, E. Brandt, V. Carter, Ku-Lang Chang, C. Edwards, Alexander Evans, Gabriela Gaona, M. Han, A. Kaplan, R. Kent, J. Kocks, Maja Kruszyk, Ledoux Chantal, Tessa LiVoti, Cathy Mahle, B. Make, A. Ratigan, A. Shaikh, N. Skolnik, Brooklyn Stanley, B. Yawn, D. Price
Introduction Little is known about the variability in chronic obstructive pulmonary disease (COPD) management and how it may be affected by patient characteristics across different healthcare systems in the US. This study aims to describe demographic and clinical characteristics of people with COPD and compare management across five primary care medical groups in the US. Methods This is a retrospective observational registry study utilizing electronic health records stored in the Advancing the Patient Experience (APEX) COPD registry. The APEX registry contains data from five US healthcare organizations located in Texas, Ohio, Colorado, New York, and North Carolina. Data on demographic and clinical characteristics of primary care patients with COPD between December 2019 and January 2020 were extracted and compared. Results A total of 17,192 patients with COPD were included in analysis: Texas (n = 811), Ohio (n = 8722), Colorado (n = 472), New York (n = 1149) and North Carolina (n = 6038). The majority of patients at each location were female (>54%) and overweight/obese (>60%). Inter-location variabilities were noted in terms of age, race/ethnicity, exacerbation frequency, treatment pattern, and prevalence of comorbid conditions. Patients from the Colorado site experienced the lowest number of exacerbations per year while those from the New York site reported the highest number. Hypertension was the most common co-morbidity at 4 of 5 sites with the highest prevalence in New York. Depression was the most common co-morbidity in Ohio. Treatment patterns also varied by site; Colorado had the highest proportion of patients not on any treatment. ICS/LABA was the most commonly prescribed treatment except in Ohio, where ICS/LABA/LAMA was most common. Conclusions and Relevance Our data show heterogeneity in demographic, clinical, and treatment characteristics of patients diagnosed with COPD who are managed in primary care across different healthcare organizations in the US.
引言对美国不同医疗系统中慢性阻塞性肺病(COPD)管理的可变性以及患者特征对其的影响知之甚少。本研究旨在描述COPD患者的人口统计学和临床特征,并比较美国五个初级保健医疗组的管理。方法这是一项回顾性观察性登记研究,利用存储在促进患者体验(APEX)COPD登记中的电子健康记录。APEX注册表包含来自德克萨斯州、俄亥俄州、科罗拉多州、纽约州和北卡罗来纳州的五个美国医疗保健组织的数据。提取并比较了2019年12月至2020年1月期间COPD初级保健患者的人口统计学和临床特征数据。结果共有17192名COPD患者被纳入分析:德克萨斯州(n=811)、俄亥俄州(n=8722)、科罗拉多州(n=472)、纽约州(n=1149)和北卡罗来纳州(n=6038)。每个位置的大多数患者为女性(>54%)和超重/肥胖(>60%)。注意到年龄、种族/民族、恶化频率、治疗模式和共病患病率方面的地区间差异。来自科罗拉多州的患者每年的病情恶化次数最少,而来自纽约州的患者报告的病情加重次数最多。在纽约发病率最高的5个地区中,有4个地区的高血压是最常见的合并发病率。抑郁症是俄亥俄州最常见的并发症。治疗模式也因地点而异;科罗拉多州没有接受任何治疗的患者比例最高。ICS/LABA是最常见的处方治疗方法,但俄亥俄州除外,那里的ICS/LABA/LAMA最常见。结论和相关性我们的数据显示,在美国不同医疗机构的初级保健中,被诊断为COPD的患者在人口统计学、临床和治疗特征方面存在异质性。
{"title":"Variation in Demographic and Clinical Characteristics of Patients with COPD Receiving Care in US Primary Care: Data from the Advancing the Patient EXperience (APEX) in COPD Registry","authors":"C. Fox, W. Pace, E. Brandt, V. Carter, Ku-Lang Chang, C. Edwards, Alexander Evans, Gabriela Gaona, M. Han, A. Kaplan, R. Kent, J. Kocks, Maja Kruszyk, Ledoux Chantal, Tessa LiVoti, Cathy Mahle, B. Make, A. Ratigan, A. Shaikh, N. Skolnik, Brooklyn Stanley, B. Yawn, D. Price","doi":"10.2147/POR.S342736","DOIUrl":"https://doi.org/10.2147/POR.S342736","url":null,"abstract":"Introduction Little is known about the variability in chronic obstructive pulmonary disease (COPD) management and how it may be affected by patient characteristics across different healthcare systems in the US. This study aims to describe demographic and clinical characteristics of people with COPD and compare management across five primary care medical groups in the US. Methods This is a retrospective observational registry study utilizing electronic health records stored in the Advancing the Patient Experience (APEX) COPD registry. The APEX registry contains data from five US healthcare organizations located in Texas, Ohio, Colorado, New York, and North Carolina. Data on demographic and clinical characteristics of primary care patients with COPD between December 2019 and January 2020 were extracted and compared. Results A total of 17,192 patients with COPD were included in analysis: Texas (n = 811), Ohio (n = 8722), Colorado (n = 472), New York (n = 1149) and North Carolina (n = 6038). The majority of patients at each location were female (>54%) and overweight/obese (>60%). Inter-location variabilities were noted in terms of age, race/ethnicity, exacerbation frequency, treatment pattern, and prevalence of comorbid conditions. Patients from the Colorado site experienced the lowest number of exacerbations per year while those from the New York site reported the highest number. Hypertension was the most common co-morbidity at 4 of 5 sites with the highest prevalence in New York. Depression was the most common co-morbidity in Ohio. Treatment patterns also varied by site; Colorado had the highest proportion of patients not on any treatment. ICS/LABA was the most commonly prescribed treatment except in Ohio, where ICS/LABA/LAMA was most common. Conclusions and Relevance Our data show heterogeneity in demographic, clinical, and treatment characteristics of patients diagnosed with COPD who are managed in primary care across different healthcare organizations in the US.","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":null,"pages":null},"PeriodicalIF":8.9,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44347565","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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 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 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
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Pragmatic and Observational Research
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