Johann Kuhn, Valérie Olié, Clémence Grave, Yann Le Strat, Christophe Bonaldi, Pierre Joly
{"title":"Impact of Smoking Reduction Scenarios on the Burden of Myocardial Infarction in the French Population Until 2035","authors":"Johann Kuhn, Valérie Olié, Clémence Grave, Yann Le Strat, Christophe Bonaldi, Pierre Joly","doi":"10.2147/clep.s440815","DOIUrl":"https://doi.org/10.2147/clep.s440815","url":null,"abstract":"<strong>Aim:</strong> Myocardial infarction (MI) is a cardiovascular disease caused by necrosis of the myocardium, which places a heavy burden on patients. In France, the proportion of daily smokers remains high, reaching at 25.5% in 2020. We evaluated the impact of smoking reduction scenarios on the projection of MI prevalence, mean age of incident cases and number of MI prevented cases until 2035.<br/><strong>Methods and Results:</strong> The French government has introduced smoking cessation policies that have led to an annual decrease in smoking prevalence. Based on this annual decline, we implemented three scenarios (SC) simulating an annual decrease in the proportion of smokers aged over 35 (SC1: 1%, ie, natural evolution without intervention, SC2: 2%, SC3: 9.87%) and a fourth scenario (SC4) in which there is a complete discontinuation of smoking from 2024 onwards using MI hospitalization and demographic data, estimations for the proportion of daily smokers between 35 and 95 years and multi-state models. Between 2023 and 2035, MI prevalence increased from 3.18% to 4.23% in males and from 1.00% to 1.46% in females under SC1. MI prevalence was equal to 4.21%, 4.06%, and 3.82% in males and 1.45%, 1.40%, and 1.34% in females in 2035 according to SC2, SC3, and SC4, respectively. Compared with SC1, 0.68% MI cases would be prevented with SC2, 4.52% with SC3 and 10.34% with SC4, with almost half of cases being prevented before 65 years of age. The increase in the mean age of MI incident cases ranged from 3 to 4 years among males and from 1 to 2 years among females.<br/><strong>Conclusion:</strong> While reducing tobacco use could substantially reduce the number of MI cases prevented, its prevalence would continue to increase due to the ageing population. An integrated prevention strategy that includes the leading cardiovascular risk factors should more efficiently reduce the future burden of MI.<br/><br/><strong>Keywords:</strong> myocardial infarction, prevalence, burden, projection, tobacco control, smoking prevalence<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"3 1","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142203747","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clinical EpidemiologyPub Date : 2024-09-04eCollection Date: 2024-01-01DOI: 10.2147/CLEP.S493274
Avid Wijaya, Endang Sri Dewi Hastuti Suryandari, Dea Allan Karunia Sakti, Tsalits Maulidah Hariez, Harinto Nur Seha
{"title":"Using Routinely Collected Electronic Healthcare Record Data to Investigate Fibrotic Multimorbidity in England [Letter].","authors":"Avid Wijaya, Endang Sri Dewi Hastuti Suryandari, Dea Allan Karunia Sakti, Tsalits Maulidah Hariez, Harinto Nur Seha","doi":"10.2147/CLEP.S493274","DOIUrl":"10.2147/CLEP.S493274","url":null,"abstract":"","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"603-604"},"PeriodicalIF":3.4,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11380843/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142153286","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Burden of Gastrointestinal Tumors in Asian Countries, 1990–2021: An Analysis for the Global Burden of Disease Study 2021","authors":"Donglin Jiang, Yangxue Wu, Ling Liu, Yajing Shen, Tiandong Li, Yin Lu, Peng Wang, Changqing Sun, Kaijuan Wang, Keyan Wang, Hua Ye","doi":"10.2147/clep.s472553","DOIUrl":"https://doi.org/10.2147/clep.s472553","url":null,"abstract":"<strong>Background:</strong> Gastrointestinal tumors represent a significant component of the cancer burden in Asia. This study aims to evaluate the burden of gastrointestinal tumors in Asia from 1990 to 2021 using data from the Global Burden of Disease Study 2021 (GBD 2021).<br/><strong>Methods:</strong> The absolute incidence, mortality, and disability adjusted life years (DALYs) number and rate of six gastrointestinal tumors(colon and rectum cancer (CRC), stomach cancer (SC), pancreatic cancer (PC), esophageal cancer (EC), liver cancer (LC) and gallbladder and biliary tract cancer (GBTC)) in 48 Asian countries were extracted from GBD 2021. Differences were analyzed based on gender, age, year, location and socio-demographic index (SDI).<br/><strong>Results:</strong> In 2021, SC accounted for the highest disease burden in Asia (DALYs=16.41million [95% <em>UI</em>: 13.70, 19.62]). From 1990 to 2021, the age-standardized incidence rates of EC, LC, and SC in Asia declined, while the incidence rates of CRC and PC increased significantly, with CRC showing the largest rise (AAPC=1.08 [95% <em>CI</em>: 1.02 to 1.12]). Gastrointestinal tumors DALY rates peaked at age 70 and above, with males generally exhibiting higher rates than females. Furthermore, East Asia bears a higher burden compared to other Asian subregions. A higher SDI correlates with increased DALY rates for PC, but no linear relationship was observed for other gastrointestinal tumors.<br/><strong>Conclusion:</strong> The burden of gastrointestinal tumors in Asia remains high and may continue to increase. Therefore, effective prevention and treatment measures are essential to address the challenge posed by gastrointestinal tumors.<br/><br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"55 1","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142203768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clinical EpidemiologyPub Date : 2024-09-03eCollection Date: 2024-01-01DOI: 10.2147/CLEP.S463363
Guilian Birindwa, Michael Maeng, Pernille Gro Thrane, Christine Gyldenkerne, Reimar Wernich Thomsen, Kevin Kris Warnakula Olesen
{"title":"Causes of Excess Mortality in Diabetes Patients Without Coronary Artery Disease: A Cohort Study Revealing Endocrinologic Contributions.","authors":"Guilian Birindwa, Michael Maeng, Pernille Gro Thrane, Christine Gyldenkerne, Reimar Wernich Thomsen, Kevin Kris Warnakula Olesen","doi":"10.2147/CLEP.S463363","DOIUrl":"10.2147/CLEP.S463363","url":null,"abstract":"<p><strong>Background: </strong>Diabetes mellitus (DM) patients without coronary artery disease (CAD) have a higher all-cause mortality rate than patients with neither DM nor CAD. We examined cause-specific death of DM patients with and without CAD.</p><p><strong>Methods: </strong>We conducted a cohort study of all patients who underwent CAG in Western Denmark between 2003 and 2016. Using Danish health registries, patients were followed for a maximum of 10 years and stratified according to their DM and CAD status. Outcomes included all-cause-, cancer-, circulatory-, and endocrinologic death. Ten-year cumulative risks were computed as well as adjusted and unadjusted hazard ratios (aHR and HR).</p><p><strong>Results: </strong>A total of 132,432 patients (28,524 deaths, median follow-up of 6.2 years) were included. Compared to patients with neither DM nor CAD, DM patients without CAD had a higher 10-year risk of all-cause death (27.9% versus 19.7%, aHR 1.43 [95% CI 1.35-1.52]), cancer death (7.2% versus 5.4%, aHR 1.29 [95% CI 1.15-1.46]), circulatory death (9.1% versus 6.9%, aHR 1.35 [95% CI 1.22-1.49]), and endocrinologic death (3.9% versus 0.3%, aHR 14.02 [95% CI 10.95-17.95]). Among endocrinologic deaths, 87% were due to classical complications of DM, such as diabetic nephropathy and ketoacidosis, in DM patients without CAD.</p><p><strong>Conclusion: </strong>Diabetes patients without CAD exhibit a higher risk of all-cause mortality, driven primarily by elevated rates of cancer, circulatory, and endocrinologic deaths, particularly related to diabetic microvascular complications.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"571-585"},"PeriodicalIF":3.4,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11380490/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142153285","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jonas F Ludvigsson, Johan Askling, Sven Cnattingius, Per Hall, Lars Klareskog, Olof Nyren, John A Baron, Henrik Toft Sørensen
{"title":"Obituary – Anders Ekbom","authors":"Jonas F Ludvigsson, Johan Askling, Sven Cnattingius, Per Hall, Lars Klareskog, Olof Nyren, John A Baron, Henrik Toft Sørensen","doi":"10.2147/clep.s490837","DOIUrl":"https://doi.org/10.2147/clep.s490837","url":null,"abstract":"<strong>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"21 1","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142203748","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clinical EpidemiologyPub Date : 2024-08-28eCollection Date: 2024-01-01DOI: 10.2147/CLEP.S459600
Derek J Bays, Emily N Jenkins, Meghan Lyman, Tom Chiller, Nora Strong, Luis Ostrosky-Zeichner, Martin Hoenigl, Peter G Pappas, George R Thompson Iii
{"title":"Epidemiology of Invasive Candidiasis.","authors":"Derek J Bays, Emily N Jenkins, Meghan Lyman, Tom Chiller, Nora Strong, Luis Ostrosky-Zeichner, Martin Hoenigl, Peter G Pappas, George R Thompson Iii","doi":"10.2147/CLEP.S459600","DOIUrl":"10.2147/CLEP.S459600","url":null,"abstract":"<p><p>Invasive candidiasis (IC) is an increasingly prevalent, costly, and potentially fatal infection brought on by the opportunistic yeast, <i>Candida</i>. Previously, IC has predominantly been caused by <i>C. albicans</i> which is often drug susceptible. There has been a global trend towards decreasing rates of infection secondary to <i>C. albicans</i> and a rise in non-<i>albicans</i> species with a corresponding increase in drug resistance creating treatment challenges. With advances in management of malignancies, there has also been an increase in the population at risk from IC along with a corresponding increase in incidence of breakthrough IC infections. Additionally, the emergence of <i>C. auris</i> creates many challenges in management and prevention due to drug resistance and the organism's ability to transmit rapidly in the healthcare setting. While the development of novel antifungals is encouraging for future management, understanding the changing epidemiology of IC is a vital step in future management and prevention.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"549-566"},"PeriodicalIF":3.4,"publicationDate":"2024-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11366240/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142105018","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clinical EpidemiologyPub Date : 2024-08-27eCollection Date: 2024-01-01DOI: 10.2147/CLEP.S470111
Marie Haase Juhl, Anne Estrup Olesen, Ellen Tveter Deilkås, Niels Henrik Bruun, Kirsten Høgh Obling, Nikoline Rytter, Maya Damgaard Larsen, Solvejg Kristensen
{"title":"Patient Safety Climate in Danish Primary Care: Adaption and Validation of the Danish Safety Attitudes Questionnaire (SAQ-DK-PRIM).","authors":"Marie Haase Juhl, Anne Estrup Olesen, Ellen Tveter Deilkås, Niels Henrik Bruun, Kirsten Høgh Obling, Nikoline Rytter, Maya Damgaard Larsen, Solvejg Kristensen","doi":"10.2147/CLEP.S470111","DOIUrl":"10.2147/CLEP.S470111","url":null,"abstract":"<p><strong>Background: </strong>A lack of instruments to assess patient safety climate within primary care exists. The objectives of this study were as follows: 1) To adapt the Danish hospital version of the Safety Attitudes Questionnaire (SAQ-DK) for use in primary care; 2) Test the internal consistency and the construct validity of this version; 3) Present benchmark data; and 4) Analyze variance.</p><p><strong>Methods: </strong>The SAQ-DK was adapted for use in Danish primary care settings (SAQ-DK-PRIM) and distributed to healthcare staff members from nursing homes (N = 11), homecare units (N = 4) and healthcare units (N = 2), within the municipality of Aarhus, Central Denmark Region, Denmark. Face- and content validity were assessed. The construct validity was evaluated by a set of goodness-of-fit indices. The internal reliability was evaluated using the item-rest correlations, the inter-item correlations, and Cronbach's alpha (α).</p><p><strong>Results: </strong>The adaptation process resulted in a questionnaire of 10 items. Eight hundred and thirty healthcare staffs participated (78% of the eligible respondents). In total 586 (70.6%) responses were complete and were included in the analysis. Goodness-of-fit indices from the confirmatory factor analysis showed: Chi<sup>2</sup>=46.90CFI=0.97, RMSEA = 0.063 (90% CI: 0.044-0.084), Probability RMSEA (p close)=0.12. Internal reliability was high (Cronbach's α=0.76). Proportions of participants with a positive attitude was 41.1% and did not differ between the healthcare services. Scale mean score was 70.19 (SD: 18.05) and differed between healthcare services. The safety climate scale scores did not vary according to healthcare service type. ICC was 0.68% indicating no clustering of scores by healthcare service type.</p><p><strong>Conclusion: </strong>Considering the questionnaire's applicability, short length, strengthened focus on one area of interest and validity, the SAQ-DK-PRIM can serve as a valuable tool for measuring patient safety climate within primary care settings in Denmark.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"533-547"},"PeriodicalIF":3.4,"publicationDate":"2024-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11365490/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142105019","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Örvar Arnarson, Peter Moberger, Filip Sköldberg, Kenneth Smedh, Helgi Birgisson, Ingvar Syk
{"title":"A Validation of the Swedish Colorectal Cancer Register – With Focus on Histopathology, Complications and Recurrences","authors":"Örvar Arnarson, Peter Moberger, Filip Sköldberg, Kenneth Smedh, Helgi Birgisson, Ingvar Syk","doi":"10.2147/clep.s466029","DOIUrl":"https://doi.org/10.2147/clep.s466029","url":null,"abstract":"<strong>Background:</strong> There is an urgent need to evaluate the quality of healthcare systems to improve and deliver high-quality care. Clinical registries have become important platforms for performance measurements, improvements, and clinical research. Hence, the quality of data in registries is crucial. This study aimed to assess the validity of data in the Swedish Colorectal Cancer Register (SCRCR).<br/><strong>Methods:</strong> Seven hundred patients from 12 hospitals were randomly selected and proportionally distributed among three different hospital categories in Sweden using two-stage cluster sampling. Validity was assessed by re-abstracting data from the medical files of patients reported to the SCRCR in 2015. Data on histopathology, postoperative complications, and a 3-year follow-up were selected for validation. Re-abstracted data were defined as source data, and validity was defined as the proportion of cases in the SRCRC dataset that agreed with the source data. Validity was expressed as the percentage of exact agreement of non-missing data in both data sets, and Cohen´s kappa coefficient (κ) was used to measure the strength of the agreement.<br/><strong>Results:</strong> The median agreement of the categorical histopathology variables was 93.4% (κ = 0.83). The general postoperative complication variable showed substantial agreement (84.3%, κ = 0.61). Likewise, the variable for overall cancer recurrence showed an almost perfect agreement (95.7%, κ = 0.86), whereas specific variables for local recurrence and distant recurrence displayed only moderate and fair agreement (85.9% and 89.1%, κ = 0.58 and 0.34, respectively).<br/><strong>Conclusion:</strong> Validation of the SCRCR data showed high validity of pathology data and recurrence rates, whereas detailed data on recurrence were not as good. Data on postoperative complications were less reliable, although the incidence and Clavien–Dindo grading of severe complications (grade 3b or higher) were reliable.<br/><br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"41 1","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141936949","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Morten Breinholt Søvsø, Rasmine Birch Haurum, Trine Hagelskær Ebbesen, Ann Øster Rasmussen, Logan Morgan Ward, Mads Lause Mogensen, Erika Frischknecht Christensen, Tim Alex Lindskou
{"title":"Emergency Call versus General Practitioner Requested Ambulances – Patient Mortality, Disease Severity and Pattern","authors":"Morten Breinholt Søvsø, Rasmine Birch Haurum, Trine Hagelskær Ebbesen, Ann Øster Rasmussen, Logan Morgan Ward, Mads Lause Mogensen, Erika Frischknecht Christensen, Tim Alex Lindskou","doi":"10.2147/clep.s469430","DOIUrl":"https://doi.org/10.2147/clep.s469430","url":null,"abstract":"<strong>Introduction:</strong> Ambulance requests by general practitioners for primary care patients (GP-requested) are often omitted in studies on increased demand within emergency care but may comprise a substantial patient group. We aimed to assess acute severity, intensive care unit (ICU) admission, and diagnostic pattern, including comorbidity, and mortality among GP-requested ambulance patients, compared to emergency call ambulance patients. Our hypothesis was that emergency call patients had more severe health issues than GP-requested ambulance patients.<br/><strong>Methods:</strong> Historic population-based cohort study of ambulance patients in the North Denmark Region, 2016– 2020. Hospital contact data including diagnoses, ambulance data, vital signs and vital status was linked using each patient’s unique identification number. Primary outcome measure was mortality within 1, 7, and 30 days. Secondary outcomes were disease severity expressed as modified National Early Warning Score (NEWS2), and ICU admission. Admission status and hospital diagnostic pattern, including comorbidity were described and compared.<br/><strong>Results:</strong> We included 255,487 patients. GP-requested patients (N = 119,361, 46.7%) were older (median years [IQR] 73 [58– 83] versus 61 [37– 76]) and more had moderate/severe comorbidity (11.9%, N = 13,806 versus 4.9%, N = 6145) than the emergency call patients. Prehospital mNEWS2 median scores were lower for GP-requested patients. For both groups, mNEWS2 was highest among patients aged 66+. GP-requested patients had higher 30-day mortality (9.0% (95% CI: 8.8– 9.2), N = 8996) than emergency call patients (5.2% (95% CI: 5.1– 5.4), N = 6727). Circulatory (12.0%, 11,695/97,112) and respiratory diseases (11.6%, 11,219/97,112) were more frequent among GP-requested patients than emergency call patients ((10.7%, 12,640/118,102) and (5.8%, 6858/118,102)). The highest number of deaths was found for health issues ‘circulatory diseases’ in the emergency call group and ‘other factors’ followed by “respiratory diseases” in the GP-requested group.<br/><strong>Conclusion:</strong> GP-requested patients constituted nearly half of the EMS volume, they were older, with more comorbidity, had serious conditions with substantial acute severity, and a higher 30-day mortality than emergency call patients.<br/><br/><strong>Keywords:</strong> emergency medical services, mortality, diagnoses, early warning scores, after-hours care, primary healthcare, general practitioners<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"212 1","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141869191","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Niels Obel, Matthew P Fox, Malte M Tetens, Lars Pedersen, Tyra Grove Krause, Henrik Ullum, Henrik Toft Sørensen
{"title":"Confounding and Negative Control Methods in Observational Study of SARS-CoV-2 Vaccine Effectiveness: A Nationwide, Population-Based Danish Health Registry Study","authors":"Niels Obel, Matthew P Fox, Malte M Tetens, Lars Pedersen, Tyra Grove Krause, Henrik Ullum, Henrik Toft Sørensen","doi":"10.2147/clep.s468572","DOIUrl":"https://doi.org/10.2147/clep.s468572","url":null,"abstract":"<strong>Background:</strong> Observational studies of SARS-CoV-2 vaccine effectiveness are prone to confounding, which can be illustrated using negative control methods.<br/><strong>Methods:</strong> Nationwide population-based cohort study including two cohorts of Danish residents 60– 90 years of age matched 1:1 on age and sex: A vaccinated and a non-vaccinated cohort, including 61052 SARS-CoV-2 vaccinated individuals between 1 March and 1 July 2021 and 61052 individuals not vaccinated preceding 1 July 2021. From these two cohorts, we constructed negative control cohorts of individuals diagnosed with SARS-CoV-2 infection or acute myocardial infarction, stroke, cancer, low energy fracture, or head-trauma. Outcomes were SARS-CoV-2 infection, negative control outcomes (eg, mammography, prostate biopsy, operation for cataract, malignant melanoma, examination of eye and ear), and death. We used Cox regression to calculate adjusted incidence and mortality rate ratios (aIRR and aMRR).<br/><strong>Results:</strong> Risks of SARS-CoV2 infection and all negative control outcomes were elevated in the vaccinated population, ranging from an aIRR of 1.15 (95% CI: 1.09– 1.21) for eye examinations to 3.05 (95% CI: 2.24– 4.14) for malignant melanoma. Conversely, the risk of death in the SARS-CoV-2 infected cohort and in all negative control cohorts was lower in vaccinated individuals, ranging from an aMRR of 0.23 (95% CI: 0.19– 0.26) after SARS-CoV-2 infection to 0.50 (95% CI: 0.37– 0.67) after stroke.<br/><strong>Conclusion:</strong> Our findings indicate that observational studies of SARS-CoV-2 vaccine effectiveness may be subject to substantial confounding. Therefore, randomized trials are essential to establish vaccine efficacy after the emergence of new SARS-CoV-2 variants and the rollout of multiple booster vaccines.<br/><br/><strong>Plain Language Summary:</strong> <strong>Why was this study done</strong>: After the emergence of new SARS-CoV-2 variants and the rollout of multiple booster SARS-CoV-2 vaccines, the impact of vaccination on risk of SARS-CoV-2 infection and death after the infection has mainly been explored in observational studies. We used negative control methods to investigate whether confounding affects the results of observational SARS-CoV-2 vaccine effectiveness studies.<br/><strong>Findings</strong>: We used Danish registry data obtained during the SARS-CoV-2 vaccine roll-out to conduct a nationwide, matched population-based cohort study of Danish residents 60– 90 years in which we compared vaccinated individuals with non-vaccinated individuals. Compared with unvaccinated individuals, vaccinated individuals had increased risks of SARS-CoV2 infection but also had increased risks of all negative control outcomes (mammography, prostate biopsy, operation for cataract, malignant melanoma, examination of eye and ear). The risk of death after SARS-CoV2 infection was lower in the vaccinated cohort, as was the risk of death after acute myocardia","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"1 1","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141776906","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}