Pragmatic and Observational Research最新文献

{"title":"Impact of the COVID-19 Pandemic on Trauma Service Utilization at a New York City Level I Trauma Center.","authors":"Benjamin Rosen,&nbsp;Annemarie L Pelle,&nbsp;Nisha A Lakhi","doi":"10.2147/POR.S378189","DOIUrl":"https://doi.org/10.2147/POR.S378189","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"13 ","pages":"93-103"},"PeriodicalIF":8.9,"publicationDate":"2022-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/94/1f/por-13-93.PMC9462934.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33467165","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}

{"title":"Real-World Experience with Favipiravir for the Treatment of Mild-to-Moderate COVID-19 in India.","authors":"Shashank Joshi,&nbsp;Agam Vora,&nbsp;K Venugopal,&nbsp;Pramod Dadhich,&nbsp;Anil Daxini,&nbsp;Sagar Bhagat,&nbsp;Saiprasad Patil,&nbsp;Hanmant Barkate","doi":"10.2147/POR.S364066","DOIUrl":"10.2147/POR.S364066","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"13 1","pages":"33-41"},"PeriodicalIF":8.9,"publicationDate":"2022-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9154000/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43204616","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}

{"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":"13 1","pages":"17 - 31"},"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}

{"title":"Measuring Health-Related Quality of Life in Randomised Controlled Trials: Expected and Reported Results Do Not Match","authors":"F. Wiedemann, F. Porzsolt","doi":"10.2147/POR.S350165","DOIUrl":"https://doi.org/10.2147/POR.S350165","url":null,"abstract":"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.","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"13 1","pages":"9 - 16"},"PeriodicalIF":8.9,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41695296","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}

{"title":"Deriving a Standardised Recommended Respiratory Disease Codelist Repository for Future Research.","authors":"Clare MacRae,&nbsp;Hannah Whittaker,&nbsp;Mome Mukherjee,&nbsp;Luke Daines,&nbsp;Ann Morgan,&nbsp;Chukwuma Iwundu,&nbsp;Mohammed Alsallakh,&nbsp;Eleftheria Vasileiou,&nbsp;Eimear O'Rourke,&nbsp;Alexander T Williams,&nbsp;Philip W Stone,&nbsp;Aziz Sheikh,&nbsp;Jennifer K Quint","doi":"10.2147/POR.S353400","DOIUrl":"https://doi.org/10.2147/POR.S353400","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"13 ","pages":"1-8"},"PeriodicalIF":8.9,"publicationDate":"2022-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c4/03/por-13-1.PMC8859726.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39958272","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}

{"title":"Risk Predictors and Symptom Features of Long COVID Within a Broad Primary Care Patient Population Including Both Tested and Untested Patients.","authors":"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","doi":"10.2147/POR.S316186","DOIUrl":"10.2147/POR.S316186","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"12 ","pages":"93-104"},"PeriodicalIF":8.9,"publicationDate":"2021-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/a1/c3/por-12-93.PMC8366779.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9397750","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}

{"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}

{"title":"Patients with Sore Throat: A Survey of Self-Management and Healthcare-Seeking Behavior in 13 Countries Worldwide.","authors":"Alike W van der Velden,&nbsp;Aurelio Sessa,&nbsp;Attila Altiner,&nbsp;Antonio Carlos Campos Pignatari,&nbsp;Adrian Shephard","doi":"10.2147/POR.S255872","DOIUrl":"https://doi.org/10.2147/POR.S255872","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"11 ","pages":"91-102"},"PeriodicalIF":8.9,"publicationDate":"2020-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S255872","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38521663","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}

{"title":"The CHRONICLE Study of US Adults with Subspecialist-Treated Severe Asthma: Objectives, Design, and Initial Results.","authors":"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","doi":"10.2147/POR.S251120","DOIUrl":"10.2147/POR.S251120","url":null,"abstract":"<p><strong>Background: </strong>Approximately 5-10% of patients with asthma have severe disease. High-quality real-world studies are needed to identify areas for improved management.</p><p><strong>Objective: </strong>Aligned with the International Severe Asthma Registry, the CHRONICLE study (ClinicalTrials.gov: NCT03373045) was developed to address this need in the US.</p><p><strong>Study design: </strong>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.</p><p><strong>Initial results: </strong>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.</p><p><strong>Conclusion: </strong>CHRONICLE will provide high-quality provider- and patient-reported data from a large, real-world cohort of US adults with subspecialist-treated severe asthma.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"11 ","pages":"77-90"},"PeriodicalIF":8.9,"publicationDate":"2020-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/b2/64/por-11-77.PMC7371434.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38239305","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}

{"title":"CPAP Therapeutic Options for Obstructive Sleep Apnea.","authors":"Robert G Hooper","doi":"10.2147/POR.S258632","DOIUrl":"https://doi.org/10.2147/POR.S258632","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Discussion: </strong>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.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"11 ","pages":"67-76"},"PeriodicalIF":8.9,"publicationDate":"2020-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S258632","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38239304","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}