Pub 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
Background: 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.
Methods: 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).
Results: 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.
Conclusion: 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.
{"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}
Pub 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
Invasive candidiasis (IC) is an increasingly prevalent, costly, and potentially fatal infection brought on by the opportunistic yeast, Candida. Previously, IC has predominantly been caused by C. albicans which is often drug susceptible. There has been a global trend towards decreasing rates of infection secondary to C. albicans and a rise in non-albicans 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 C. auris 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.
侵袭性念珠菌病(IC)是由机会性酵母菌白色念珠菌引起的一种日益流行、代价高昂且可能致命的感染。以前,IC 主要由白色念珠菌引起,而白色念珠菌通常对药物敏感。全球趋势是白念珠菌继发感染率下降,非白念珠菌感染率上升,耐药性也相应增加,这给治疗带来了挑战。随着恶性肿瘤治疗的进步,IC 的高危人群也在增加,突破性 IC 感染的发病率也相应增加。此外,由于耐药性和该病菌在医疗环境中的快速传播能力,法氏囊菌的出现给管理和预防带来了许多挑战。新型抗真菌药物的开发为未来的管理带来了鼓舞,而了解不断变化的 IC 流行病学则是未来管理和预防的重要一步。
{"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}
Pub 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
Background: 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.
Methods: 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).
Results: 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: Chi2=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.
Conclusion: 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.
{"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
Background: 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). Methods: 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. Results: 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). Conclusion: 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.
{"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
Introduction: 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. Methods: 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. Results: 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. Conclusion: 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.
Keywords: emergency medical services, mortality, diagnoses, early warning scores, after-hours care, primary healthcare, general practitioners
{"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
<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
{"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}
Rayan Nikkilä, Elli Hirvonen, Janne Pitkäniemi, Jari V Räsänen, Nea K Malila, Antti Mäkitie
Purpose: The occurrence of a second primary cancer (SPC) after primary esophageal carcinoma (EC) or gastric cardia carcinoma(GCC) is well acknowledged. However, previous research on the risk of SPC among these patients has been predominantly conducted in Asian countries. Yet, notable population-dependent variation in histological types and risk profiles exists. This register-based study assesses the histology-specific risk of SPC among individuals initially diagnosed with a first primary EC or GCC. Patients and Methods: We obtained data on 7197 patients diagnosed with EC/GCC in Finland between 1980 and 2022 from the Finnish Cancer Registry. Standardized incidence ratios (SIR) of SPC were subsequently calculated relatively to the cancer risk of the general population. Results: The average and median follow-up times were 2.8 years and 10.5 months. Adenocarcinomas and squamous cell carcinomas comprised 57.8% (n = 4165) and 36.6% (n = 2631) of all cases, respectively. An increased SIR was noted among EC/GCC patients after 15– 20 years of follow-up (SIR 1.49, 95% CI: 1.01– 2.11). Among adenocarcinoma patients, an increased SIR for SPCs of the digestive organs was seen in the 40– 54-year-old group (SIR 9.86, 95% CI: 3.62– 21.45). Squamous cell carcinoma patients displayed increased SIRs for cancer of the mouth/pharynx (SIR 3.20, 95% CI: 1.17– 6.95) and respiratory organs (1.77, 1.07– 2.76). Conclusion: Healthcare professionals should be aware of the increased risk of SPCs occurring in the mouth/pharynx, respiratory and digestive organs in survivors of EC/GCC. Patients should be advised about this risk and remain alert for symptoms, even beyond the standard 5-year follow-up period.
Keywords: esophageal squamous cell carcinoma, adenocarcinoma, gastric cardia carcinoma, tumor, second primary cancer
{"title":"Risk of Second Primary Cancer Among Patients with Cardio-Esophageal Cancer in Finland: A Nationwide Population-Based Study","authors":"Rayan Nikkilä, Elli Hirvonen, Janne Pitkäniemi, Jari V Räsänen, Nea K Malila, Antti Mäkitie","doi":"10.2147/clep.s471802","DOIUrl":"https://doi.org/10.2147/clep.s471802","url":null,"abstract":"<strong>Purpose:</strong> The occurrence of a second primary cancer (SPC) after primary esophageal carcinoma (EC) or gastric cardia carcinoma(GCC) is well acknowledged. However, previous research on the risk of SPC among these patients has been predominantly conducted in Asian countries. Yet, notable population-dependent variation in histological types and risk profiles exists. This register-based study assesses the histology-specific risk of SPC among individuals initially diagnosed with a first primary EC or GCC.<br/><strong>Patients and Methods:</strong> We obtained data on 7197 patients diagnosed with EC/GCC in Finland between 1980 and 2022 from the Finnish Cancer Registry. Standardized incidence ratios (SIR) of SPC were subsequently calculated relatively to the cancer risk of the general population.<br/><strong>Results:</strong> The average and median follow-up times were 2.8 years and 10.5 months. Adenocarcinomas and squamous cell carcinomas comprised 57.8% (n = 4165) and 36.6% (n = 2631) of all cases, respectively. An increased SIR was noted among EC/GCC patients after 15– 20 years of follow-up (SIR 1.49, 95% CI: 1.01– 2.11). Among adenocarcinoma patients, an increased SIR for SPCs of the digestive organs was seen in the 40– 54-year-old group (SIR 9.86, 95% CI: 3.62– 21.45). Squamous cell carcinoma patients displayed increased SIRs for cancer of the mouth/pharynx (SIR 3.20, 95% CI: 1.17– 6.95) and respiratory organs (1.77, 1.07– 2.76).<br/><strong>Conclusion:</strong> Healthcare professionals should be aware of the increased risk of SPCs occurring in the mouth/pharynx, respiratory and digestive organs in survivors of EC/GCC. Patients should be advised about this risk and remain alert for symptoms, even beyond the standard 5-year follow-up period.<br/><br/><strong>Keywords:</strong> esophageal squamous cell carcinoma, adenocarcinoma, gastric cardia carcinoma, tumor, second primary cancer<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"24 1","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141745865","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}
Johannes Leiner, Vincent Pellissier, Sebastian König, Lars Stellmacher, Sven Hohenstein, Carolin Schanner, Stefan Kwast, Ralf Kuhlen, Andreas Bollmann
Introduction: Type 2 diabetes mellitus (T2DM) is a leading cause of chronic kidney disease (CKD) globally. Both conditions substantially worsen patients’ prognosis. Current data on German in-hospital CKD cohorts are scarce. The multinational CaReMe study was initiated to evaluate the current epidemiology and healthcare burden of cardiovascular, renal and metabolic diseases. In this substudy, we share real-world data on CKD inpatients stratified for coexisting T2DM derived from a large German hospital network. Methods: This study used administrative data of inpatient cases from 89 Helios hospitals from 01/01/2016 to 28/02/2022. Data were extracted from ICD-10-encoded discharge diagnoses and OPS-encoded procedures. The first case meeting a previously developed CKD definition (defined by ICD-10- and OPS-codes) was considered the index case for a particular patient. Subsequent hospitalizations were analysed for readmission statistics. Patient characteristics and pre-defined endpoints were stratified for T2DM at index case. Results: In total, 48,011 patients with CKD were included in the present analysis (mean age ± standard deviation, 73.8 ± 13.1 years; female, 44%) of whom 47.9% had co-existing T2DM. Patients with T2DM were older (75 ± 10.6 vs 72.7 ± 14.9 years, p < 0.001), but gender distribution was similar to patients without T2DM. The burden of cardiovascular disease was increased in patients with T2DM, and index and follow-up in-hospital mortality rates were higher. Non-T2DM patients were characterised by more advanced CKD at baseline. Patients with T2DM had consistently higher readmission numbers for all events of interest, except for readmissions due to kidney failure/dialysis, which were more common in non-T2DM patients. Conclusion: In this study, we present recent data on hospitalized patients with CKD in Germany. In this CKD cohort, nearly half had T2DM, which substantially affected cardiovascular disease burden, rehospitalization frequency and mortality. Interestingly, non-diabetic patients had more advanced underlying renal disease, which affected renal outcomes.
{"title":"Patient Characteristics and Outcomes of Hospitalized Chronic Kidney Disease Patients with and without Type 2 Diabetes Mellitus: Observations from the German Claims Data-Based Cohort of the CaReMe-CKD Multinational Study","authors":"Johannes Leiner, Vincent Pellissier, Sebastian König, Lars Stellmacher, Sven Hohenstein, Carolin Schanner, Stefan Kwast, Ralf Kuhlen, Andreas Bollmann","doi":"10.2147/clep.s459767","DOIUrl":"https://doi.org/10.2147/clep.s459767","url":null,"abstract":"<strong>Introduction:</strong> Type 2 diabetes mellitus (T2DM) is a leading cause of chronic kidney disease (CKD) globally. Both conditions substantially worsen patients’ prognosis. Current data on German in-hospital CKD cohorts are scarce. The multinational CaReMe study was initiated to evaluate the current epidemiology and healthcare burden of cardiovascular, renal and metabolic diseases. In this substudy, we share real-world data on CKD inpatients stratified for coexisting T2DM derived from a large German hospital network.<br/><strong>Methods:</strong> This study used administrative data of inpatient cases from 89 Helios hospitals from 01/01/2016 to 28/02/2022. Data were extracted from ICD-10-encoded discharge diagnoses and OPS-encoded procedures. The first case meeting a previously developed CKD definition (defined by ICD-10- and OPS-codes) was considered the index case for a particular patient. Subsequent hospitalizations were analysed for readmission statistics. Patient characteristics and pre-defined endpoints were stratified for T2DM at index case.<br/><strong>Results:</strong> In total, 48,011 patients with CKD were included in the present analysis (mean age ± standard deviation, 73.8 ± 13.1 years; female, 44%) of whom 47.9% had co-existing T2DM. Patients with T2DM were older (75 ± 10.6 vs 72.7 ± 14.9 years, p < 0.001), but gender distribution was similar to patients without T2DM. The burden of cardiovascular disease was increased in patients with T2DM, and index and follow-up in-hospital mortality rates were higher. Non-T2DM patients were characterised by more advanced CKD at baseline. Patients with T2DM had consistently higher readmission numbers for all events of interest, except for readmissions due to kidney failure/dialysis, which were more common in non-T2DM patients.<br/><strong>Conclusion:</strong> In this study, we present recent data on hospitalized patients with CKD in Germany. In this CKD cohort, nearly half had T2DM, which substantially affected cardiovascular disease burden, rehospitalization frequency and mortality. Interestingly, non-diabetic patients had more advanced underlying renal disease, which affected renal outcomes. <br/><br/><strong>Keywords:</strong> chronic kidney disease, type 2 diabetes mellitus, administrative data, in-hospital mortality, kidney failure, rehospitalization<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"44 1","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141745868","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}
Yiwang Zhou, Madeline R Horan, Samira Deshpande, Kirsten K Ness, Melissa M Hudson, I-Chan Huang, Deokumar Srivastava
Purpose: Childhood cancer survivors experience interconnected symptoms, patterns of which can be elucidated by network analysis. However, current symptom networks are constructed based on the average survivors without considering individual heterogeneities. We propose to evaluate personal symptom network estimation using the Ising model with covariates through simulations and estimate personal symptom network for adult childhood cancer survivors. Patients and Methods: We adopted the Ising model with covariates to construct networks by employing logistic regressions for estimating associations between binary symptoms. Simulation experiments assessed the robustness of this method in constructing personal symptom network. Real-world data illustration included 1708 adult childhood cancer survivors from the St. Jude Lifetime Cohort Study (SJLIFE), a retrospective cohort study with prospective follow-up to characterize the etiology and late effects for childhood cancer survivors. Patients’ baseline symptoms in 10 domains (cardiac, pulmonary, sensation, nausea, movement, pain, memory, fatigue, anxiety, depression) and individual characteristics (age, sex, race/ethnicity, attained education, personal income, and marital status) were self-reported using survey. Treatment variables (any chemo or radiation therapy) were obtained from medical records. Personal symptom network of 10 domains was estimated using the Ising model, incorporating individual characteristics and treatment data. Results: Simulations confirmed the robustness of the Ising model with covariates in constructing personal symptom networks. Real-world data analysis identified age, sex, race/ethnicity, education, marital status, and treatment (any chemo and radiation therapy) as major factors influencing symptom co-occurrence. Older childhood cancer survivors showed stronger cardiac-fatigue associations. Survivors of racial/ethnic minorities had stronger pain-fatigue associations. Female survivors with above-college education demonstrated stronger pain-anxiety associations. Unmarried survivors who received radiation had stronger association between movement and memory problems. Conclusion: The Ising model with covariates accurately estimates personal symptom networks. Individual heterogeneities exist in symptom co-occurrence patterns for childhood cancer survivors. The estimated personal symptom network offers insights into interconnected symptom experiences.
{"title":"Estimation of Personal Symptom Networks Using the Ising Model for Adult Survivors of Childhood Cancer: A Simulation Study with Real-World Data Application","authors":"Yiwang Zhou, Madeline R Horan, Samira Deshpande, Kirsten K Ness, Melissa M Hudson, I-Chan Huang, Deokumar Srivastava","doi":"10.2147/clep.s464104","DOIUrl":"https://doi.org/10.2147/clep.s464104","url":null,"abstract":"<strong>Purpose:</strong> Childhood cancer survivors experience interconnected symptoms, patterns of which can be elucidated by network analysis. However, current symptom networks are constructed based on the average survivors without considering individual heterogeneities. We propose to evaluate personal symptom network estimation using the Ising model with covariates through simulations and estimate personal symptom network for adult childhood cancer survivors.<br/><strong>Patients and Methods:</strong> We adopted the Ising model with covariates to construct networks by employing logistic regressions for estimating associations between binary symptoms. Simulation experiments assessed the robustness of this method in constructing personal symptom network. Real-world data illustration included 1708 adult childhood cancer survivors from the St. Jude Lifetime Cohort Study (SJLIFE), a retrospective cohort study with prospective follow-up to characterize the etiology and late effects for childhood cancer survivors. Patients’ baseline symptoms in 10 domains (cardiac, pulmonary, sensation, nausea, movement, pain, memory, fatigue, anxiety, depression) and individual characteristics (age, sex, race/ethnicity, attained education, personal income, and marital status) were self-reported using survey. Treatment variables (any chemo or radiation therapy) were obtained from medical records. Personal symptom network of 10 domains was estimated using the Ising model, incorporating individual characteristics and treatment data.<br/><strong>Results:</strong> Simulations confirmed the robustness of the Ising model with covariates in constructing personal symptom networks. Real-world data analysis identified age, sex, race/ethnicity, education, marital status, and treatment (any chemo and radiation therapy) as major factors influencing symptom co-occurrence. Older childhood cancer survivors showed stronger cardiac-fatigue associations. Survivors of racial/ethnic minorities had stronger pain-fatigue associations. Female survivors with above-college education demonstrated stronger pain-anxiety associations. Unmarried survivors who received radiation had stronger association between movement and memory problems.<br/><strong>Conclusion:</strong> The Ising model with covariates accurately estimates personal symptom networks. Individual heterogeneities exist in symptom co-occurrence patterns for childhood cancer survivors. The estimated personal symptom network offers insights into interconnected symptom experiences.<br/><br/><strong>Keywords:</strong> bootstrap testing, individual heterogeneity, Ising model, network analysis, sociodemographic<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"9 1","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141718277","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}