Pub Date : 2024-10-16DOI: 10.1016/j.amjmed.2024.10.007
Mariana Barosa, Vinay Prasad
Background: Postlicensure observational studies are the mainstay of vaccine safety evaluation. However, these studies have well-known methodological limitations, rendering them particularly vulnerable to unmeasured confounding. We sought to describe high-impact observational studies of vaccine safety, investigate the authors' attitudes toward their study's findings and limitations, and report on spin practices.
Methods: We conducted a PubMed systematic review of comparative observational studies of vaccine safety published in the 6 top medical journals from inception to March 2024.
Results: Thirty-seven studies were included, spanning publications from 1995 to 2024. Most studies focused on COVID-19 and influenza vaccines (n = 11, 30%, and n = 10, 27%, respectively). Study designs and methodologies varied. Electronic health records (54%), passive surveillance databases (32%), and national registries (27%) were the most common data sources. Negative control outcomes were used in a single study. Residual confounding was conceded in 54% of studies, and an additional 24% did so implicitly. Spin was noted in 48.6% of the studies. This systematic review found that authors of observational vaccine safety studies in high-impact medical journals often acknowledge residual confounding, but rarely use methods like negative control outcomes to better detect unmeasured confounding. Furthermore, spin is common, occurring in approximately 50% of the studies.
Conclusions: Although our findings are somewhat limited by subjectivity in study assessments, they suggest that editors and reviewers of high-impact journals should ensure that the language used in reporting observational studies accurately reflects the findings and their limitations.
{"title":"Characteristics of Vaccine Safety Observational Studies and Authors' Attitudes: A Systematic Review.","authors":"Mariana Barosa, Vinay Prasad","doi":"10.1016/j.amjmed.2024.10.007","DOIUrl":"10.1016/j.amjmed.2024.10.007","url":null,"abstract":"<p><strong>Background: </strong>Postlicensure observational studies are the mainstay of vaccine safety evaluation. However, these studies have well-known methodological limitations, rendering them particularly vulnerable to unmeasured confounding. We sought to describe high-impact observational studies of vaccine safety, investigate the authors' attitudes toward their study's findings and limitations, and report on spin practices.</p><p><strong>Methods: </strong>We conducted a PubMed systematic review of comparative observational studies of vaccine safety published in the 6 top medical journals from inception to March 2024.</p><p><strong>Results: </strong>Thirty-seven studies were included, spanning publications from 1995 to 2024. Most studies focused on COVID-19 and influenza vaccines (n = 11, 30%, and n = 10, 27%, respectively). Study designs and methodologies varied. Electronic health records (54%), passive surveillance databases (32%), and national registries (27%) were the most common data sources. Negative control outcomes were used in a single study. Residual confounding was conceded in 54% of studies, and an additional 24% did so implicitly. Spin was noted in 48.6% of the studies. This systematic review found that authors of observational vaccine safety studies in high-impact medical journals often acknowledge residual confounding, but rarely use methods like negative control outcomes to better detect unmeasured confounding. Furthermore, spin is common, occurring in approximately 50% of the studies.</p><p><strong>Conclusions: </strong>Although our findings are somewhat limited by subjectivity in study assessments, they suggest that editors and reviewers of high-impact journals should ensure that the language used in reporting observational studies accurately reflects the findings and their limitations.</p>","PeriodicalId":50807,"journal":{"name":"American Journal of Medicine","volume":" ","pages":""},"PeriodicalIF":4.6,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142479956","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-16DOI: 10.1016/j.amjmed.2024.09.015
{"title":"In the Pursuit of Immortality, Who is Sitting at the Table?","authors":"","doi":"10.1016/j.amjmed.2024.09.015","DOIUrl":"10.1016/j.amjmed.2024.09.015","url":null,"abstract":"","PeriodicalId":50807,"journal":{"name":"American Journal of Medicine","volume":"137 12","pages":"Page e243"},"PeriodicalIF":2.5,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142695975","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-16DOI: 10.1016/j.amjmed.2024.05.019
Oscar M.P. Jolobe MRCP(UK)
{"title":"The Burden of Heart Failure in the Obese Patient","authors":"Oscar M.P. Jolobe MRCP(UK)","doi":"10.1016/j.amjmed.2024.05.019","DOIUrl":"10.1016/j.amjmed.2024.05.019","url":null,"abstract":"","PeriodicalId":50807,"journal":{"name":"American Journal of Medicine","volume":"137 12","pages":"Page e242"},"PeriodicalIF":2.5,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142696063","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-15DOI: 10.1016/j.amjmed.2024.10.010
Shiori Kitaya, Reina Iyobe, Hajime Kanamori
{"title":"Disseminated Herpes Zoster in an Immunocompromised Patient: Challenges for Preventing Transmission Before Diagnosis.","authors":"Shiori Kitaya, Reina Iyobe, Hajime Kanamori","doi":"10.1016/j.amjmed.2024.10.010","DOIUrl":"10.1016/j.amjmed.2024.10.010","url":null,"abstract":"","PeriodicalId":50807,"journal":{"name":"American Journal of Medicine","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142479971","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-15DOI: 10.1016/j.amjmed.2024.10.014
Genevieve M Y Tan, Ying Na Ho, Glenn K W Yong
{"title":"Unraveling Tuberculosis: An Atypical Tuberculous Presentation.","authors":"Genevieve M Y Tan, Ying Na Ho, Glenn K W Yong","doi":"10.1016/j.amjmed.2024.10.014","DOIUrl":"10.1016/j.amjmed.2024.10.014","url":null,"abstract":"","PeriodicalId":50807,"journal":{"name":"American Journal of Medicine","volume":" ","pages":""},"PeriodicalIF":4.6,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142479979","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-15DOI: 10.1016/j.amjmed.2024.09.017
Meagan Lacroix, Fred Abdelmalek, Karl Everett, Monica Taljaard, Lena Salach, Lindsay Bevan, Victoria Burton, Hui Jia, Jennifer Shuldiner, Celia Laur, Emily Nicholas Angl, Noah M Ivers, Mina Tadrous
Background: Opioids, prescribed to manage pain, are associated with safety risks. Quality improvement strategies such as audit and feedback and academic detailing may improve prescribing in primary care.
Methods: We used a matched-cohort design with claims databases. Participants were family physicians practicing in Ontario, Canada. The interventions were a voluntary audit and feedback report with or without academic detailing sessions. Physicians in the control group received neither intervention. The primary outcome was mean rate of high-risk opioid prescriptions per 100 patients per month. Data were analyzed comparing monthly percentage change in slope over 12 months before and 18 months after the intervention. Additional analyses considered only the subgroup of higher-prescribing physicians.
Results: There were 1469 (25%) physicians in the audit and feedback group, 245 (4%) in the audit and feedback + academic detailing group, and 4211 (71%) matched controls. All groups showed a significant preintervention decline in opioid prescribing. There were no significant between-group differences in opioid prescribing postintervention. Among high-prescribing physicians, there was a significant reduction in the audit and feedback group (% change in slope = -0.37, 95% CI = -0.65 to -0.09, P < .01), but not in the academic detailing group (% change in slope = 0.19, 95% CI = -0.52 to 0.91, P = .59).
Conclusions: This study demonstrated declining secular trends in prescribing and suggests that two large-scale initiatives had limited additional benefits. We found some additional reductions after audit and feedback among the highest-volume opioid prescribers. Future interventions should focus on these physicians for the greatest benefit.
{"title":"Effectiveness of Audit and Feedback and Academic Detailing Interventions to Support Safer Opioid Prescribing in Primary Care.","authors":"Meagan Lacroix, Fred Abdelmalek, Karl Everett, Monica Taljaard, Lena Salach, Lindsay Bevan, Victoria Burton, Hui Jia, Jennifer Shuldiner, Celia Laur, Emily Nicholas Angl, Noah M Ivers, Mina Tadrous","doi":"10.1016/j.amjmed.2024.09.017","DOIUrl":"10.1016/j.amjmed.2024.09.017","url":null,"abstract":"<p><strong>Background: </strong>Opioids, prescribed to manage pain, are associated with safety risks. Quality improvement strategies such as audit and feedback and academic detailing may improve prescribing in primary care.</p><p><strong>Methods: </strong>We used a matched-cohort design with claims databases. Participants were family physicians practicing in Ontario, Canada. The interventions were a voluntary audit and feedback report with or without academic detailing sessions. Physicians in the control group received neither intervention. The primary outcome was mean rate of high-risk opioid prescriptions per 100 patients per month. Data were analyzed comparing monthly percentage change in slope over 12 months before and 18 months after the intervention. Additional analyses considered only the subgroup of higher-prescribing physicians.</p><p><strong>Results: </strong>There were 1469 (25%) physicians in the audit and feedback group, 245 (4%) in the audit and feedback + academic detailing group, and 4211 (71%) matched controls. All groups showed a significant preintervention decline in opioid prescribing. There were no significant between-group differences in opioid prescribing postintervention. Among high-prescribing physicians, there was a significant reduction in the audit and feedback group (% change in slope = -0.37, 95% CI = -0.65 to -0.09, P < .01), but not in the academic detailing group (% change in slope = 0.19, 95% CI = -0.52 to 0.91, P = .59).</p><p><strong>Conclusions: </strong>This study demonstrated declining secular trends in prescribing and suggests that two large-scale initiatives had limited additional benefits. We found some additional reductions after audit and feedback among the highest-volume opioid prescribers. Future interventions should focus on these physicians for the greatest benefit.</p>","PeriodicalId":50807,"journal":{"name":"American Journal of Medicine","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142479972","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-09DOI: 10.1016/j.amjmed.2024.09.028
Ali Saad, Eric J Brandt, Kamil F Faridi, Jeremy W Paster, Sohum Sheth, Andrew M Freeman, Verity Ramirez, Monica Aggarwal
Cardiovascular disease is the leading cause of death in the United States. Poor dietary habits are not only a major modifiable risk factor for cardiovascular disease and other chronic illnesses, but they also harm planetary health. Our food system is complex, shaped by agricultural practices and human behaviors. To change it, we need to understand why current agricultural practices exist and address nutrition education, food insecurity, and nutritional security. There are effective ways to make our food system healthier, more equitable, and more sustainable. The best available evidence points to plant-forward diets as the keystone to this complex issue. This manuscript reviews how human and planetary health are connected through our food system and suggests solutions for diets that prevent and treat cardiovascular disease while promoting planetary health.
{"title":"Rethinking Our Roots: The Ground-Up Approach to Heart Health & Planetary Sustainability.","authors":"Ali Saad, Eric J Brandt, Kamil F Faridi, Jeremy W Paster, Sohum Sheth, Andrew M Freeman, Verity Ramirez, Monica Aggarwal","doi":"10.1016/j.amjmed.2024.09.028","DOIUrl":"10.1016/j.amjmed.2024.09.028","url":null,"abstract":"<p><p>Cardiovascular disease is the leading cause of death in the United States. Poor dietary habits are not only a major modifiable risk factor for cardiovascular disease and other chronic illnesses, but they also harm planetary health. Our food system is complex, shaped by agricultural practices and human behaviors. To change it, we need to understand why current agricultural practices exist and address nutrition education, food insecurity, and nutritional security. There are effective ways to make our food system healthier, more equitable, and more sustainable. The best available evidence points to plant-forward diets as the keystone to this complex issue. This manuscript reviews how human and planetary health are connected through our food system and suggests solutions for diets that prevent and treat cardiovascular disease while promoting planetary health.</p>","PeriodicalId":50807,"journal":{"name":"American Journal of Medicine","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142394999","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-05DOI: 10.1016/j.amjmed.2024.10.001
Smita Pakhale
{"title":"The Four Ts of Mentoring Minorities.","authors":"Smita Pakhale","doi":"10.1016/j.amjmed.2024.10.001","DOIUrl":"10.1016/j.amjmed.2024.10.001","url":null,"abstract":"","PeriodicalId":50807,"journal":{"name":"American Journal of Medicine","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142395000","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-05DOI: 10.1016/j.amjmed.2024.09.001
Lintao Dan, Ying Xie, Tian Fu, Yuhao Sun, Xuejie Chen, Xiaoyan Wang, Chenkai Wu, Jie Chen, Xue Li
Background: Cross-sectional evidence suggests a higher burden of chronic respiratory diseases in people with inflammatory bowel disease, but there is a lack of prospective evidence to clarify the direction of their associations. We aimed to investigate the association of inflammatory bowel disease with the risk of 2 major chronic respiratory diseases, chronic obstructive pulmonary disease, and asthma.
Methods: We included 430,414 participants from UK Biobank and followed them from recruitment (2006-2010) to 2021. Chronic obstructive pulmonary disease and asthma cases were obtained from inpatient data and death register. Using Cox proportional hazards models, we estimated the multivariable-adjusted hazard ratios (HR) of developing chronic obstructive pulmonary disease and asthma in participants with inflammatory bowel disease compared with inflammatory bowel disease-free groups. We also investigated the association among Crohn's disease and ulcerative colitis with the risk of chronic obstructive pulmonary disease and asthma.
Results: Over a median follow-up of 11.9 years, there were 11,196 incidents of chronic obstructive pulmonary disease and 9831 asthma cases. The adjusted HRs of developing chronic obstructive pulmonary disease (HR 1.54; 95% confidence interval [CI], 1.33-1.79) and asthma (HR 1.52; 95% CI, 1.29-1.79) were higher for those with inflammatory bowel disease when compared with inflammatory bowel disease-free participants. Participants with Crohn's disease and ulcerative colitis were also found to have a higher risk of chronic obstructive pulmonary disease (Crohn's disease: HR 1.71; 95% CI, 1.36-2.15; ulcerative colitis: HR 1.45; 95% CI, 1.20-1.75) and asthma (Crohn's disease: HR 1.73; 95% CI, 1.33-2.25; ulcerative colitis: HR 1.41; 95% CI, 1.15-1.73) when compared with those free of inflammatory bowel disease.
Conclusions: This study suggested that individuals with inflammatory bowel disease have a higher risk of developing chronic obstructive pulmonary disease and asthma, highlighting the importance of preventing chronic respiratory diseases among inflammatory bowel disease patients.
{"title":"Increased Risk of Chronic Respiratory Disease among Individuals with Inflammatory Bowel Disease in a Prospective Cohort Study.","authors":"Lintao Dan, Ying Xie, Tian Fu, Yuhao Sun, Xuejie Chen, Xiaoyan Wang, Chenkai Wu, Jie Chen, Xue Li","doi":"10.1016/j.amjmed.2024.09.001","DOIUrl":"10.1016/j.amjmed.2024.09.001","url":null,"abstract":"<p><strong>Background: </strong>Cross-sectional evidence suggests a higher burden of chronic respiratory diseases in people with inflammatory bowel disease, but there is a lack of prospective evidence to clarify the direction of their associations. We aimed to investigate the association of inflammatory bowel disease with the risk of 2 major chronic respiratory diseases, chronic obstructive pulmonary disease, and asthma.</p><p><strong>Methods: </strong>We included 430,414 participants from UK Biobank and followed them from recruitment (2006-2010) to 2021. Chronic obstructive pulmonary disease and asthma cases were obtained from inpatient data and death register. Using Cox proportional hazards models, we estimated the multivariable-adjusted hazard ratios (HR) of developing chronic obstructive pulmonary disease and asthma in participants with inflammatory bowel disease compared with inflammatory bowel disease-free groups. We also investigated the association among Crohn's disease and ulcerative colitis with the risk of chronic obstructive pulmonary disease and asthma.</p><p><strong>Results: </strong>Over a median follow-up of 11.9 years, there were 11,196 incidents of chronic obstructive pulmonary disease and 9831 asthma cases. The adjusted HRs of developing chronic obstructive pulmonary disease (HR 1.54; 95% confidence interval [CI], 1.33-1.79) and asthma (HR 1.52; 95% CI, 1.29-1.79) were higher for those with inflammatory bowel disease when compared with inflammatory bowel disease-free participants. Participants with Crohn's disease and ulcerative colitis were also found to have a higher risk of chronic obstructive pulmonary disease (Crohn's disease: HR 1.71; 95% CI, 1.36-2.15; ulcerative colitis: HR 1.45; 95% CI, 1.20-1.75) and asthma (Crohn's disease: HR 1.73; 95% CI, 1.33-2.25; ulcerative colitis: HR 1.41; 95% CI, 1.15-1.73) when compared with those free of inflammatory bowel disease.</p><p><strong>Conclusions: </strong>This study suggested that individuals with inflammatory bowel disease have a higher risk of developing chronic obstructive pulmonary disease and asthma, highlighting the importance of preventing chronic respiratory diseases among inflammatory bowel disease patients.</p>","PeriodicalId":50807,"journal":{"name":"American Journal of Medicine","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142382245","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}