Right Atrial Mass Secondary to Breast Cancer Metastasis.

We present the case of a 42-year-old female with a history of human epidermal growth factor 2 (HER2) receptor-positive breast cancer status post bilateral mastectomy with metastasis to the spine and to the brain, who underwent transesophageal echocardiography (TEE) after outpatient transthoracic echocardiography (TTE) was suggestive of right atrial thrombus in transit. TEE revealed an atrial mass with a pedunculated stalk attached to the inferior right atrium near the inferior vena cava with a necrotic center. These findings were suggestive of an endocardial metastatic mass secondary to her primary breast cancer. The pericardium is the most common site of cardiac metastasis; meanwhile, endocardial involvement is infrequent, occurring in less than 5% of all cardiac metastases. Right atrial masses may cause evidence of right heart failure and thromboembolism of the pulmonary arteries. Treatment focuses on targeted chemotherapy, radiation therapy, and interventions as indicated. In this case, following the diagnosis of a right atrial mass, the patient was discharged the same day to begin outpatient chemotherapy.

Obesity, stigma, and person-centered language: A serial cross-sectional analysis of scientific literature.

OBJECTIVE: Language can influence societal perceptions of medical conditions. The employment of person-centered language (PCL) in health care is reflected in many scientific publications; however, the extent of this adaptation in reference to obesity is unknown. METHODS: This cross-sectional analysis included a systematic search of PubMed obesity-related articles across four cohorts spanning January 2004 through December 2006; January 2008 through December 2010; January 2015 through December 2018; and January 2019 through May 2020, respectively. Approximately 1971 publications were screened and examined for prespecified, non-PCL terminology set forth by the American Medical Association Manual of Style and the International Committee of Medical Journal Editors, of which 991 were retained. Statistical analysis demonstrating PCL and non-PCL findings was then performed. Incidence rates and cohort classifications were reported. RESULTS: Of the 991 articles examined, it was found that 24.02% of publications adhered to PCL. Similar adherence was observed across obesity-specific, general medicine, and nutrition journals. PCL adherence increased over time. The most common non-PCL label was "obese," occurring in 75.48% of articles. CONCLUSIONS: This investigation showed that non-PCL in reference to obesity is widely evident in weight-focused journals despite recommendations for adherence to PCL guidelines. Continued use of non-PCL in reference to obesity in research may inadvertently perpetuate weight-based stigma and health disparities in future generations.

Intestinal Mycobacterium avium Complex Infection in a Kidney Transplant Patient.

Opportunistic infections are the result of infection by bacteria, viral, and fungal sources potentially leading to severe disease and death. These infections are a cause of significant morbidity and mortality among individuals with profound immunosuppression, namely human immunodeficiency virus (HIV), and organ transplant recipients on medications used to prevent organ rejection. Mycobacterium avium complex (MAC) is one of the most prevalent pathogens worldwide as it is found ubiquitously in water, food, and soil and is commonly a source of disseminated disease among the immunocompromised. However, cases of kidney transplantation remain exceedingly rare with an estimated incidence of 0.16% and 0.55%. We present the case of a 68-year-old female with a history of a kidney transplant, currently on immunosuppressant therapy, who was found to have localized MAC infection after undergoing endoscopic evaluation for symptoms of generalized weakness and unintentional weight loss secondary to anemia.

An Analysis of the Evidence Informing Clinical Practice Guidelines in the Management and Treatment of Breast Cancer.

OBJECTIVE: The aim of this study was to assess the methodological quality and accuracy of reporting within systematic reviews (SRs) that provide evidence to form clinical practice guidelines (CPGs) in the management and treatment of breast cancer. METHODS: The 5 included CPGs for breast cancer management among National Comprehensive Cancer Network and European Society for Medical Oncology were searched for all SRs and meta-analyses. The characteristics of each study along with their methodological reporting were extracted from each SR using the PRISMA (Preferred Reporting Instrument for Systematic Reviews and Meta-Analyses) and AMSTAR-2 (A Measurement Tool to Assess Systematic Reviews 2) tools. Our second objective was to compare SRs produced by Cochrane groups vs non-Cochrane. RESULTS: Our study included 5 CPGs for the management of breast cancer, containing 1341 total references with 69 being unique SRs we analyzed. PRISMA completeness percent had a mean 76.3% (n = 69), while AMSTAR-2 completeness score mean was 66.5% (n = 59). Cochrane SRs were found to adhere far better to PRISMA (0.91 vs. 0.74) and AMSTAR-2 (0.95 vs. 0.62) guidelines compared to the non-Cochrane SRs. CONCLUSION: The reporting quality of SRs that underpin CPGs in breast cancer management widely varies. We recommend that authors of SRs adopt a more uniform approach in assessing the quality of reporting within their studies. In addition, CPGs should use a more standardized method to seek out evidence to establish their recommendations. With improved reporting, clinicians may have increased confidence in CPGs and thus increased utilization of CPGs in clinical decision making.

Quality of reporting among systematic reviews underpinning the ESC/ACC guidelines on ventricular arrhythmias and sudden cardiac death.

OBJECTIVES: The main objective of this study was to assess the methodological and reporting quality of the systematic reviews (SRs) supporting the European Society of Cardiology (ESC) and the American College of Cardiology (ACC) clinical practice guidelines (CPGs) recommendations for the management of patients with ventricular arrhythmias and sudden cardiac death (SCD). As a secondary objective, we sought to determine: (1) the proportion of Cochrane SRs were cited; and (2) whether Cochrane SRs scored higher on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR-2) appraisals. DESIGN: Cross-sectional analysis. MAIN OUTCOME MEASURES: We searched for CPGs published by the ESC and the ACC from 2010 to 2020. We selected the CPGs for ventricular arrhythmias and the prevention of SCD. The reference sections were searched for SRs. Two independent investigators evaluated eligible SR using the PRISMA checklist and the AMSTAR-2 assessment tool. RESULTS: Two CPGs for ventricular arrhythmia and SCD were included in this study. Fifty-five SRs were included in our analysis. Across all SRs, the mean PRISMA score was 0.70. The lowest scoring PRISMA item related to the presence of a pre-published protocol (item 5, score 0.17). Overall, 40% of included SRs were found to have 'critically low' AMSTAR-2 ratings. One of the lowest scoring items for AMSTAR-2 was reporting of sources of funding (item 10). The 4 Cochrane SRs that were included scored higher on both assessment tools than non-Cochrane studies, specifically in PRISMA overall completion (88.7% vs 69.7%). CONCLUSION: Our study suggests the methodological and reporting quality of SRs used within ESC and ACC CPGs is insufficient, as demonstrated by the lack of adherence to both AMSTAR-2 and PRISMA checklists. Given the importance of CPGs on clinical decision making, and ultimately patient care, the methodological rigour and quality reporting within SRs used in CPGs should be held to the highest standard within the field of cardiology.

An analysis of publication trends of orthopedic surgery residency graduates in relation to academic achievement.

CONTEXT: Traditionally, the Accreditation Council for Graduate Medical Education (ACGME) requires residency programs to implement research and other scholarly activities into their training curriculum. Encouraging residents to publish during residency is believed to promote research throughout their careers; however, no study has attempted to quantify research productivity among orthopedic surgery residents before, during, and after residency. OBJECTIVES: To determine whether publishing in peer-reviewed journals during orthopedic residencies was an indicator of continued academic achievement after graduation. METHODS: This study was observational in nature and employed a cross-sectional design. We examined whether research outcomes during orthopedic residency was associated with academic advancement or continued research involvement after residency. We identified 201 orthopedic residency programs on the Doximity website and randomly selected 50 to include in our sample. Of these programs, graduate rosters for 31 programs were located and subsequently included. Of the 341 graduates identified, we recorded the number of peer-reviewed publications, H-indices, fellowships, and whether the graduate pursued a career in private practice or academia. RESULTS: Orthopedic residency graduates from 31 programs published a total of 1923 peer-reviewed manuscripts. On average, residents had a total of 5.6 publications and an h-index of 3.2. Residents entering academia and pursuing fellowships had a significantly higher total number of publications, higher number of first-author publications, and greater H-indices compared to those who did not enter academia or pursue a fellowship. CONCLUSIONS: Increased research productivity was associated with continued academic pursuits and an increased likelihood of pursuing fellowship training after residency.

An analysis of the evidence underpinning the national comprehensive cancer network practice guidelines.

OBJECTIVE: This study assesses the quality and completeness of systematic reviews (SRs) included by the National Comprehensive Cancer Network (NCCN) cancer screening clinical practice guidelines (CPGs). METHODS: We evaluated SRs according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and AMSTAR-2 (A Measurement Tool to Assess systematic Reviews). RESULTS: Seven NCCN CPGs were included with 109 SRs. The mean PRISMA percent completeness of included SRs was 71 % (range 0.1-1.0). The mean AMSTAR-2 percent completeness was 56 % (range 0.05-0.99). Of the 70 SRs assessed via AMSTAR-2, 42 (60 %) received a "critically low" rating, 11 (15.7 %) received "low" ratings, and 17 (24.3 %) received "moderate". None of the SRs received a "high" rating. CONCLUSION: Lack of adherence to AMSTAR-2 and PRISMA reporting standards among the SRs included is prevalent. We suggest improved reporting of SR inclusion criteria and evaluation to bolster the reporting quality of SRs underpinning CPG recommendations.

An analysis of the rates of discontinuation and non-publication of colorectal cancer clinical trials.

PURPOSE: Non-publication and premature discontinuation for clinical trials pose an ethical dilemma for trial participants, patients, clinicians, and researchers, as well as the general public as these studies receive significant public funding that may be further contributing to research waste. Here, we investigate the rate of trial discontinuation and non-publication among CRC trials using ClinicalTrials.gov. METHODS: We performed an advanced search on ClinicalTrials.gov pertaining to the treatment of CRC using the keyword colorectal cancer. For each clinical trial, links to the publication provided by ClinicalTrials.gov were searched and verified to be correct. If a publication was unable to be found using the methods above, we attempted to contact the lead investigator via email for the reason for non-publication. RESULTS: Of the 123 (123/428, 28.7%) discontinued trials, a reason for discontinuation was provided for 57 (57/123, 46.3%) trials. Of the 305 (305/428, 71.3%) completed trials, 244 (244/305, 80.0%) had a verifiable publication, while 61 (61/305, 20.0%) did not publish their findings or were unable to be located. CONCLUSION: We found that more than one-quarter of trials were prematurely ended, and almost one-third of completed trials did not publish their findings. Subjecting trial participants to potentially harmful treatments and interventions that fail to complete or publish study findings have the potential to undermine the patient-provider relationship, as well as public confidence in government-sponsored clinical trials.

Myopericarditis in a Young Adult Secondary to COVID-19 Vaccination.

We present the case of a healthy 29-year-old male with no significant medical history who presented with electrocardiogram findings consistent with pericarditis and elevated troponin levels, commonly seen in myocarditis, after receiving his second Pfizer-BioNTec vaccination for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). The patient had significant clinical improvement shortly after receiving aspirin and colchicine and was discharged home with these medications. His laboratory findings returned to baseline less than 2 weeks after his illness. While this case highlights the importance of diagnosis, intervention selection, and treatment of myopericarditis amid ongoing global vaccination campaigns, it should be emphasized that the benefits of vaccination considerably outweigh the risks.

Publication Trends and Their Relationship With Academic Success Among Dermatology Residents: Cross-sectional Analysis.

BACKGROUND: Involvement in scholarly activities is considered to be one of the foundational pillars of medical education. OBJECTIVE: This study aims to investigate publication rates before, during, and after residency to determine whether research productivity throughout medical training correlates with future academic success and research involvement. METHODS: We successfully identified a list of 296 graduates from 25 US dermatology residency programs from the years 2013-2015. The publication history for each graduate was compiled using Scopus, PubMed, and Google Scholar. The Pearson correlation test and linear regression were used to assess the relationship between research productivity and continued academic success after residency graduation. RESULTS: Before residency, graduates published a mean of 1.9 (SD 3.5) total publications and a mean of 0.88 (SD 1.5) first-author publications. During residency, graduates published a mean of 2.7 (SD 3.6) total publications and a mean of 1.39 (SD 2.0) first-author publications. Graduates who pursued a fellowship had more total publications (t294=-4.0; P<.001), more first-author publications (t294=-3.9; P<.001), and a higher h-index (t294=-3.8; P=.002). Graduates who chose to pursue careers in academic medicine had more mean total publications (t294=-7.5; P<.001), more first-author publications (t294=-5.9; P<.001), and a higher mean h-index (t294=-6.9; P<.001). Graduates with one or more first-author publications before residency were 1.3 times more likely to pursue a career in academic medicine (adjusted odds ratio 1.3, 95% CI 1.1-1.5). Graduates who pursued a fellowship were also 1.9 times more likely to pursue a career in academic medicine (adjusted odds ratio 1.9, 95% CI 1.2-3.2). CONCLUSIONS: Our results suggest that research productivity before and during residency training are potential markers for continued academic success and research involvement after completing dermatology residency training.

Are randomized controlled trials being conducted with the right justification?

OBJECTIVE: It has been estimated that much of health research may be wasted, resulting in billions of dollars in wasteful research spending worldwide each year. Given the increased use of randomized trials and their influence on medicine, one method to combat research waste is to conduct randomized clinical trials (RCTs) only when a systematic review (SR) suggests more data are needed or when no previous SRs are identified. Here, we analyzed RCTs to determine whether SRs were cited as justification for conducting a trial. METHODS: We analyzed phase III RCTs published between 2016 and 2018 in New England Journal of Medicine, Lancet, and JAMA. We performed duplicate and independent data extraction to ensure the accuracy and validity of our data. For each trial, we extracted whether SRs were cited as justification for conducting the clinical trial. RESULTS: We examined 637 RCTs that cited 728 SRs. Overall, 38.1% (243/637) of RCTs cited an SR as either verbatim (6.9%, 44/637) or inferred (31.2%, 199/637) for trial justification. The 79 remaining RCTs cited SRs in other ways. Approximately, 49.5% (315/637) of RCTs did not cite a SR. CONCLUSIONS: Less than half of the analyzed clinical trials cited a SRs as the basis for undertaking the trial. We believe trialists should be required to present relevant SRs to an ethics or peer review committee demonstrating an unmet need prior to initiating a trial. Eliminating research waste is both a scientific and ethical responsibility.

Lowering the threshold of statistical significance in gastroenterology trials.

A multidisciplinary international cohort of 72 expert statisticians and researchers recently proposed lowering the p value threshold from 0.05 to 0.005 to mitigate distortion of trial results and decrease bias. We hereby explored how a change to the p value threshold may alter the statistical significance of primary endpoints in gastroenterology (GE) randomized control trials (RCTs). We analyzed RCTs published in the 20 highest ranked GE and medicine journals. For each trial, we extracted the p values for the corresponding primary endpoints. We retrieved 233 RCTs, of which 159 were included in the final analysis yielding 202 primary endpoints. Of these endpoints, 60% had a p value less than 0.05 and when a threshold of less than 0.005 was applied, approximately 50% retained significance. We endorse a lower p value threshold as an actionable, provisional measure for improving statistical inference in GE RCTs until more long-term solutions become available.

Evaluation of Financial Conflicts of Interest Among Physician-Authors of American College of Rheumatology Clinical Practice Guidelines.

OBJECTIVE: Clinical practice guidelines (CPGs) underpin patient care, and ideally authors of these guidelines would be free from outside influence. However, it has been shown many times that authors of professional society CPGs receive large sums of money from industry drug companies, creating financial conflicts of interest. This study investigated industry payments catalogued in the Open Payments Database (OPD) that have been received by authors of the American College of Rheumatology (ACR) CPGs. METHODS: Guidelines on the ACR web site that were published during or after August 2014 were used to retrieve the list of authors. All general, research, associated research, and ownership payments reported on the OPD between the date of publication of the CPG and 12 months prior were extracted in a parallel and blinded manner by 2 investigators. RESULTS: Of the 89 US-based physician-authors from the 5 ACR CPGs identified within the study timeframe, 56 (62.9%) had received at least 1 payment according to OPD records. These 56 authors had received a median of $522 (interquartile range $119-2,500), which, combined, was a total of $9,728,751. Nineteen authors had received at least 1 industry payment relevant to the CPG recommendations, for a median amount of $748 and a total of $1,961,362 in relevant payments. Of the total relevant payments received, a significant proportion was undisclosed (for ACR CPGs during or after August 2014, undisclosed payments were $699,561, or 35.7% of the total). CONCLUSION: Fewer than one-half of the US-based physician-authors of ACR CPGs during or after August 2014 had received guideline-relevant industry payments. Nonetheless, a substantial proportion of the money received was not disclosed. Conflict of interest disclosure is a bare minimum requirement, and more permanent solutions may include divestiture or inclusion of more nonconflicted authors.

Are results from randomized trials in anesthesiology robust or fragile? An analysis using the fragility index.

AIM: In anesthesiology, the findings from randomized controlled trials often underpin guidelines influencing clinical decision-making and therefore directly affect patient care. The aim of this study is to evaluate the fragility index and fragility quotient of randomized controlled trials published in the eight highest ranked anesthesiology journals. In addition, we assess the extent to which risk of bias scores, loss to follow-up, Web of Science Citation Index, and journal impact factor influence fragility index and fragility quotient. METHODS: We included randomized trials published between 2014 and 2016 from the eight highest ranking anesthesiology journals based on Clarivate Analytics' Science Citation Index and Google Scholar Metrics: Anesthesiology subcategory. We included journals that published general anesthesia topics and omitted specialty anesthesia journals. The fragility index and fragility quotient for all included trials were calculated. Risk of bias for each trial was evaluated using the Cochrane 'risk of bias' Tool 2.0. RESULTS: One hundred and thirty one randomized control trials were included in this analysis. The median fragility index was 3 (interquartile range 1.0-5.5) with a fragility quotient of 0.03 (interquartile range 0.01-0.08). In 11% (14/131) of trials, the number of patients lost to follow-up was greater than the corresponding fragility index. Weak correlations were found between fragility index and total sample size (r = 0.13) and between fragility index and event frequency (r = 0.19). A near-negligible correlation was found between 5-year impact factor and fragility index (r = -0.03) and, similarly, between fragility index and Science Citation Index (r = -0.05). Ten trials were at high risk of bias with the randomization process found to be the domain at the highest risk of bias. CONCLUSION: In assessing the fragility of randomized controlled trials published in the top eight anesthesiology journals, our study suggests that statistically significant results in these journals are disconcertingly fragile. The median fragility index calculated from our 131 primary studies reveals that only three nonevents must be replaced with events to negate statistical significance. Although a current scale does not exist for fragility index ranges, many trials published by the top journals in anesthesiology are based on concerning methodology and highly fragile outcomes. With small median sample sizes and few patient events characterizing a large number of these trials, many of today's current guidelines and clinical practices may be founded on research containing statistical significance but lacking clinical significance.

The use of systematic reviews to justify orthopaedic trauma randomized controlled trials: A cross-sectional analysis.

OBJECTIVE: Orthopaedic trauma is one of the largest surgical fields in medicine, and as such, requires the latest evidence to ensure the best standard of care. Systematic reviews are an invaluable resource that compiles an exhaustive summary of the most current evidence on a given clinical question. The primary aim of this study is to evaluate the use of systematic reviews as justification in conducting randomized controlled trials published in high impact orthopaedic trauma journals. METHODS: We analyzed randomized controlled trials published in the top three high impact orthopaedic trauma journals between 2015 and 2018. We performed data extraction blind, independent, and in duplicative manner to ensure the validity of the findings. For each trial, data was extracted by the number of systematic reviews cited in each clinical trial and whether or not the study used a systematic review as justification for conducting the trial. A subgroup of general orthopaedic clinical trials were included for comparison. RESULTS: Of 144 articles retrieved, 128 were included. Overall, 71.1% (91/128; [95% CI, 63.2-78.9]) of included orthopaedic trauma randomized controlled trials referenced a systematic review and 28.9% (37/128) of studies did not cite a systematic review. Of the 91 trials that referenced a systematic review, 33.0% (30/91; [95% CI, 23.3-42.6]) of RCTs cited a systematic review as trial justification, whether that be "verbatim" or "inferred". "Verbatim" justifications occurred in 20.0% (6/30; [95% CI, 5.7-34.3]) of included trauma RCTs that cited a systematic review as justification for conducting the trial and "inferred" justifications occurred in 80.0% (24/30; [95% CI, 65.7-94.3]). CONCLUSION: Systematic reviews are frequently cited in orthopaedic trauma RCTs but are not commonly cited as justification for conducting a clinical trial. Ideally, evidentiary uncertainty regarding a research question should be established by existing literature through a systematic review to reduce research waste.

Analysis of completeness of reporting utilizing the Reporting Items for practice Guidelines in Healthcare Statement in gastroenterology clinical practice guidelines.

AIM: Assessing reporting quality is important as it allows distinctions to be made between poor methodology and poor reporting practices. The Reporting Items for practice Guidelines in Healthcare (RIGHT) Statement checklist was published in 2017 to improve the thoroughness and reporting quality of clinical practice guidelines (CPGs). CPGs are evidence-based recommendations developed to assist clinician decision-making in the diagnosis and management of patients. The aim of this study is to assess the completeness of reporting in CPGs listed by the American College of Gastroenterology (ACG) and their frequency of reporting items listed in the RIGHT Statement. METHODS: Using the 22 criteria (35 items) of the RIGHT Statement checklist, two researchers independently documented the adherence to each item for all eligible guidelines listed by the ACG. This study was conducted from 01/10/18 to 05/12/18. Data were recorded onto a prespecified Google data abstraction form and extracted into MS Excel for statistical analysis. RESULTS: Out of 38 eligible guidelines, nine of the 35 RIGHT (25.7%) checklist items were met with less than 50% adherence. The mean adherence was 26.8 (SD ±â€Š9.5); median adherence was 30 (interquartile range 21.5-33.5). The publication dates ranged from 2007 to 2017 with seven of the guidelines (18.4%) published between 2007 and 2009, 11 (29%) published between 2010 and 2013, and 20 (52.6%) published between 2014 and 2017. CONCLUSION: The completeness of reporting in CPGs listed by the ACG remains inadequate in several key areas. Poor adherence to items of the RIGHT Statement checklist demonstrates that there is area for improvement in reporting quality.

An analysis of randomized controlled trials underpinning ST-elevation myocardial infarction management guidelines.

BACKGROUND: The fragility index (FI) is calculated by iteratively changing one outcome "event" to a "non-event" within a trial until the associated p-value exceeds 0.05. PURPOSE: To investigate the FI and fragility quotient (FQ) of trial endpoints referenced in the ACCF/AHA/SCAI guidelines in the management of ST-elevation myocardial infarctions. Secondarily, we assess the post-hoc power and risk of bias for these specific outcomes and whether differences exist between adequately and inadequately powered studies on fragility measures. BASIC PROCEDURES: All citations referenced in the guideline were screened for inclusion criteria. The FI and FQ for all included trials were then calculated. The Cochrane 'risk of bias' Tool 2.0 was used to evaluate the likelihood and sources of bias in the included trials. MAIN FINDINGS: Forty-two randomized controlled trials were included for assessment. The median FI was 10 with a FQ of 0.0055. Seven trials were at a high risk of bias, all due to bias in the randomization process. Fifteen trials were found to be underpowered. Adequately powered studies had higher FIs and FQs compared to underpowered studies. PRINCIPAL CONCLUSIONS: Our findings support the use of FI and FQ analyses with power analyses in future methodology of randomized control trials. With understanding and reporting of FI and FQ, evidence of studies can be readily available and quickly eliminate some readers' concern for possible study limitations.