Pragmatic and Observational Research最新文献

{"title":"Real World Data Studies of Antineoplastic Drugs: How Can They Be Improved to Steer Everyday Use in the Clinic?","authors":"Gincy George,&nbsp;Beth Russell,&nbsp;Anne Rigg,&nbsp;Anthony C C Coolen,&nbsp;Mieke Van Hemelrijck","doi":"10.2147/POR.S395959","DOIUrl":"https://doi.org/10.2147/POR.S395959","url":null,"abstract":"<p><p>There is a growing interest in real world evidence when developing antineoplastic drugs owing to the shorter length of time and low costs compared to randomised controlled trials. External validity of studies in the regulatory phase can be enhanced by complementing randomised controlled trials with real world evidence. Furthermore, the use of real world evidence ensures the inclusion of patients often excluded from randomised controlled trials such as the elderly, certain ethnicities or those from certain geographical areas. This review explores approaches in which real world data may be integrated with randomised controlled trials. One approach is by using big data, especially when investigating drugs in the antineoplastic setting. This can even inform artificial intelligence thus ensuring faster and more precise diagnosis and treatment decisions. Pragmatic trials also offer an approach to examine the effectiveness of novel antineoplastic drugs without evading the benefits of randomised controlled trials. A well-designed pragmatic trial would yield results with high external validity by employing a simple study design with a large sample size and diverse settings. Although randomised controlled trials can determine efficacy of antineoplastic drugs, effectiveness in the real world may differ. The need for pragmatic trials to help guide healthcare decision-making led to the development of trials within cohorts (TWICs). TWICs make use of cohorts to conduct multiple randomised controlled trials while maintaining characteristics of real world data in routine clinical practice. Although real world data is often affected by incomplete data and biases such as selection and unmeasured biases, the use of big data and pragmatic approaches can improve the use of real world data in the development of antineoplastic drugs that can in turn steer decision-making in clinical practice.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"14 ","pages":"95-100"},"PeriodicalIF":8.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/de/c2/por-14-95.PMC10493103.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10284671","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 Impact of Robotic-Assisted Bronchoscopy on the Staging and Diagnosis of Lung Cancer: The Shape of Current and Potential Opportunities.","authors":"Gabriel Ortiz-Jaimes,&nbsp;Janani Reisenauer","doi":"10.2147/POR.S395806","DOIUrl":"https://doi.org/10.2147/POR.S395806","url":null,"abstract":"<p><p>The approach to peripheral pulmonary lesions (PPL) has been evolving continuously. Advanced bronchoscopic navigational techniques have improved the airway-based approaches to these lesions. Robotic Assisted Bronchoscopy (RAB) can be considered the current pinnacle of this evolution; allowing for a safer approach to sampling lesions previously considered outside of bronchoscopic reach. We present a comprehensive review of the changing epidemiology of lung cancer and the importance of early tissue sampling, the evolution of sampling and navigational bronchoscopic techniques, technical considerations and evidence pertaining to the use of RAB, and adjunct techniques in the diagnosis of lung cancer. Complications and future applications of RAB are also discussed.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"14 ","pages":"75-94"},"PeriodicalIF":8.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/b3/f9/por-14-75.PMC10492559.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10571262","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":"Data-Resource Profile: United Kingdom Optimum Patient Care Research Database.","authors":"Anita Lynam,&nbsp;Charlotte Curtis,&nbsp;Brooklyn Stanley,&nbsp;Heath Heatley,&nbsp;Chloe Worthington,&nbsp;Emma-Jane Roberts,&nbsp;Christopher Price,&nbsp;Victoria Carter,&nbsp;John Dennis,&nbsp;Andrew McGovern,&nbsp;David Price","doi":"10.2147/POR.S395632","DOIUrl":"https://doi.org/10.2147/POR.S395632","url":null,"abstract":"<p><strong>Introduction: </strong>Electronic medical records (EMRs) maintained in primary care in the UK and collected and stored in EMR databases offer a world-leading resource for observational clinical research. We aimed to profile one such database: the Optimum Patient Care Research Database (OPCRD).</p><p><strong>Methods and participants: </strong>The OPCRD, incepted in 2010, is a growing primary care EMR database collecting data from 992 general practices within the UK. It covers over 16.6 million patients across all four countries within the UK, and is broadly representative of the UK population in terms of age, sex, ethnicity and socio-economic status. Patients have a mean duration of 11.7 years' follow-up (SD 17.50), with a majority having key summary data from birth to last data entry. Data for the OPCRD are collected incrementally monthly and extracted from all of the major clinical software systems used within the UK and across all four coding systems (Read version 2, Read CTV3, SNOMED DM+D and SNOMED CT codes). Via quality-improvement programmes provided to GP surgeries, the OPCRD also includes patient-reported outcomes from a range of disease-specific validated questionnaires, with over 66,000 patient responses on asthma, COPD, and COVID-19. Further, bespoke data collection is possible by working with GPs to collect new research via patient-reported questionnaires.</p><p><strong>Findings to date: </strong>The OPCRD has contributed to over 96 peer-reviewed research publications since its inception encompassing a broad range of medical conditions, including COVID-19.</p><p><strong>Conclusion: </strong>The OPCRD represents a unique resource with great potential to support epidemiological research, from retrospective observational studies through to embedded cluster-randomised trials. Advantages of the OPCRD over other EMR databases are its large size, UK-wide geographical coverage, the availability of up-to-date patient data from all major GP software systems, and the unique collection of patient-reported information on respiratory health.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"14 ","pages":"39-49"},"PeriodicalIF":8.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c0/f9/por-14-39.PMC10150735.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9410322","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":"Clinical Management of COPD in the Real World: Can Studies Reveal Errors in Management and Pathways to Improve Patient Care?","authors":"David M G Halpin","doi":"10.2147/POR.S396830","DOIUrl":"https://doi.org/10.2147/POR.S396830","url":null,"abstract":"<p><p>Real world data comprise information on health care that is derived from multiple sources outside typical clinical research settings. This review focuses on what real world evidence tells us about problems with the diagnosis of chronic obstructive pulmonary disease (COPD), problems with the initial and follow-up pharmacological and non-pharmacological management, problems with the management of exacerbations and problems with palliative care. Data from real world studies show errors in the management of COPD with delays to diagnosis, lack of confirmation of the diagnosis with spirometry, lack of holistic assessment, lack of attention to smoking cessation, variable adherence to management guidelines, delayed implementation of appropriate interventions, under-recognition of patients at higher risk of adverse outcomes, high hospitalisation rates for exacerbations and poor implementation of palliative care. Understanding that these problems exist and considering how and why they occur is fundamental to developing solutions to improve the diagnosis and management of patients with COPD.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"14 ","pages":"51-61"},"PeriodicalIF":8.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/49/7b/por-14-51.PMC10404047.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9950622","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-Life Effectiveness of MP-AzeFlu (Dymista^®) in Swedish Patients with Persistent Allergic Rhinitis, Assessed by the Visual Analogue Scale.","authors":"Pär Stjärne,&nbsp;Duc Tung Nguyen,&nbsp;Hans Christian Kuhl","doi":"10.2147/POR.S375403","DOIUrl":"https://doi.org/10.2147/POR.S375403","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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 <i>p</i> < 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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"14 ","pages":"1-11"},"PeriodicalIF":8.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/cf/0f/por-14-1.PMC9826638.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10870336","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":"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":"Detection of Short-Term Side Effects of ChAdOx1 nCoV-19 Vaccine: A Cross-Sectional Study in a War-Torn Country.","authors":"Mohammed Alshakka,&nbsp;Najmaddin A H Hatem,&nbsp;Wafa Badullah,&nbsp;Rabab Alsakaf,&nbsp;Ali Rageh,&nbsp;Seena Abdulla Yousef,&nbsp;Mohamed Izham Mohamed Ibrahim","doi":"10.2147/POR.S381836","DOIUrl":"https://doi.org/10.2147/POR.S381836","url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>A cross-section of vaccinated participants in Aden were surveyed by telephone. Descriptive statistics were used for statistical analysis.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":" ","pages":"85-91"},"PeriodicalIF":8.9,"publicationDate":"2022-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/60/29/por-13-85.PMC9423103.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40335613","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":"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.","authors":"Ameet Dravid,&nbsp;Dnyanesh Morkar,&nbsp;Dwijendra Prasad,&nbsp;John T Ramapuram,&nbsp;Kartik Vikrambhai Patel,&nbsp;K Sunil Naik,&nbsp;Milind Bhrusundi,&nbsp;Milind Kulkarni,&nbsp;Sanjeev Hegde,&nbsp;S Anuradha,&nbsp;Siddabathuni Nageswaramma,&nbsp;Surabhi Madan,&nbsp;Thammisetty Jayaprakash,&nbsp;Vinay Kulkarni","doi":"10.2147/POR.S361907","DOIUrl":"https://doi.org/10.2147/POR.S361907","url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":" ","pages":"75-84"},"PeriodicalIF":8.9,"publicationDate":"2022-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/b0/e5/por-13-75.PMC9375976.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40702580","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 Preferences of Modes of Child Delivery and Associated Factors Among Pregnant Women in Southern Ethiopia.","authors":"Bewunetu Zewude,&nbsp;Getahun Siraw,&nbsp;Yesuf Adem","doi":"10.2147/POR.S370513","DOIUrl":"https://doi.org/10.2147/POR.S370513","url":null,"abstract":"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.","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":" ","pages":"59-73"},"PeriodicalIF":8.9,"publicationDate":"2022-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/86/fb/por-13-59.PMC9296879.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40535116","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":"Characterisation of the Australian Adult Population Living with Asthma: Severe - Exacerbation Frequency, Long-Term OCS Use and Adverse Effects.","authors":"Kerry L Hancock,&nbsp;Sinthia Bosnic-Anticevich,&nbsp;John D Blakey,&nbsp;Mark Hew,&nbsp;Li Ping Chung,&nbsp;Biljana Cvetkovski,&nbsp;Scott Claxton,&nbsp;Peter Del Fante,&nbsp;Eve Denton,&nbsp;Joe Doan,&nbsp;Kanchanamala Ranasinghe,&nbsp;Lucy Morgan,&nbsp;Anita Sharma,&nbsp;Peter K Smith,&nbsp;Deb Stewart,&nbsp;Philip J Thompson,&nbsp;Russell Wiseman,&nbsp;John W Upham,&nbsp;Kwok Y Yan,&nbsp;Victoria Carter,&nbsp;Kiranjeet Dhillon,&nbsp;Florian Heraud,&nbsp;Thao Le,&nbsp;Rebecca Vella,&nbsp;David Price","doi":"10.2147/POR.S360044","DOIUrl":"https://doi.org/10.2147/POR.S360044","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":" ","pages":"43-58"},"PeriodicalIF":8.9,"publicationDate":"2022-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/7e/c4/por-13-43.PMC9270906.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40595530","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}