A Comparison of Individuals with Diabetes and EMPA-REG Trial Participants: Exploring Aspects of External Validity.

BACKGROUND: There is increasing use of sodium glucose co-transporter 2 (SGLT2) inhibitors to treat diabetes. Since trials apply specific entry and exclusion criteria to ensure internal validity, comparisons of trial populations with nationally representative samples can inform the applicability of study findings to practice. OBJECTIVE: To compare individuals with diabetes from a nationally representative sample to patients who underwent randomization in the EMPA-REG trial. A secondary aim was to characterize what proportion of individuals prescribed an SGLT2 inhibitor in a nationally representative sample would have been included in the EMPA-REG trial. DESIGN: Retrospective cross-sectional study. PARTICIPANTS: Adults with diabetes who took part in the National Health and Nutrition Examination Survey (NHANES) between 2011-2014 (primary analysis corresponding to EMPA-REG enrollment) and 2015-2018 (secondary analysis corresponding to contemporary sample). MAIN MEASURES: The primary outcome was a comparison of demographic (age, sex, ethnicity, and pregnancy status), clinical (comorbidities and medication use), examination (weight, body mass index, and systolic and diastolic blood pressure), and laboratory (hgba1c, low- and high-density lipoprotein cholesterol, triglycerides, and estimated glomerular filtration rate) characteristics of NHANES respondents versus EMPA-REG trial participants. The secondary outcome was the proportion of NHANES respondents who had been prescribed an SGLT2 inhibitor that would have met inclusion criteria for the EMPA-REG trial. KEY RESULTS: There were 655 and 48 respondents, representing a weighted sample of 21,849,775 and 1,062,573 individuals, included in the primary and secondary analyses, respectively. Overall, 7.6% (95% CI 4.8-10.6%) of 2011-2014 NHANES respondents would have met all EMPA-REG trial inclusion criteria. NHANES respondents and EMPA-REG participants differed across demographic, clinical, examination, and laboratory domains. Of NHANES respondents from 2015 to 2018 who were prescribed an SGLT2 inhibitor, 10.6% (95% CI <1-24.7%) would have met all inclusion criteria for the EMPA-REG trial. CONCLUSIONS: The EMPA-REG population differed from a nationally representative sample, which could affect generalizability.

Prediction model for gonorrhea, chlamydia, and trichomoniasis in the emergency department.

OBJECTIVE: History and physical examination findings can be unreliable for prediction of genitourinary tract infections and differentiation of urinary tract infections from sexually transmitted infections (STIs). The study objective was to develop a prediction tool to more accurately identify patients with STIs. METHODS: A retrospective review of 64,490 emergency department (ED) encounters between April 18, 2014, and March 7, 2017, where patients age 18 years or older had urinalysis and urine culture or testing for gonorrhea, chlamydia, or trichomonas, was used to develop a prediction model for men and women with Neisseria gonorrhoeae or Chlamydia trachomatis, or both, and for women with Trichomonas vaginalis. The data set was randomly divided into two-thirds discovery and one-third validation. Groups were assigned through a random number generator. Backward step regression modeling was used to identify the best model for each outcome. RESULTS: With use of age, race, marital status, and findings from vaginal wet preparation (white blood cells [WBCs], clue cells, and yeast) and urinalysis (squamous epithelial cells, protein, leukocyte esterase, and WBCs), the models had areas under the receiver operating characteristic curve of 0.80 for men with N gonorrhoeae or C trachomatis, or both; 0.75 for women with N gonorrhoeae or C trachomatis, or both; and 0.73 for women with T vaginalis. CONCLUSIONS: The model estimated likelihood of ED patients having STIs was reasonably accurate with a limited number of demographic and laboratory variables. In the absence of point-of-care STI testing, use of a prediction tool for STIs may improve antimicrobial stewardship.

A cross-sectional study of participant recruitment rates in published phase III influenza therapeutic randomized controlled trials conducted in the clinical setting.

OBJECTIVE: A recent academic-government partnership demonstrated the feasibility of utilizing Emergency Departments (ED) as a primary site for subject enrollment in clinical trials and achieved high rates of recruitment in two U.S. EDs. Given the ongoing need to test new therapeutics for influenza and other emerging infections, we sought to describe the historical rates of participant recruitment into influenza Phase III therapeutic RCTs in various clinical venues, including EDs. STUDY DESIGN: A cross-sectional study was performed of influenza therapeutic Phase III RCTs published in PubMed, Embase, Scopus, and Clinicaltrials.gov from January 2000 to June 2019. MAIN OUTCOME: To estimate the weighted-average number of influenza-positive participants enrolled per site per season in influenza therapeutic RCT conducted in clinical settings, and to describe basic trial site characteristics. RESULTS: 47 (0.7%) of 7008 articles were included for review of which 43 of 47 (91%) included information regarding enrollment sites; of these, 2 (5%) recruited exclusively from EDs with the remainder recruiting from mixed clinical settings (inpatient, outpatient, and ED). The median enrollment per study was 326 (IQR: 110, 502.5) with a median of 11 sites per study (IQR: 2, 59.5). Included studies reported a median of 201 (IQR: 74, 344.5) confirmed influenza-positive participants per study. The pooled number of participants enrolled per site per season was 11 (95% CI: 10, 12). The pooled enrollment numbers per clinical site after excluding the two 'ED only recruitment' studies were less [10.7 (95% CI: 9.9, 11.6)] than the pooled enrollment numbers per clinical site for the two 'ED only recruitment' studies [89.5 (95% CI 89.2-89.27)]. CONCLUSION AND RELEVANCE: Published RCTs evaluating influenza therapeutics in clinical settings recruit participants from multiple sites but enroll relatively few participants, per site, per season. The few ED-based studies reported recruited more subjects per site per season. Untapped opportunities likely exist for EDs to participate and/or lead therapeutic RCTs for influenza or other emerging respiratory pathogens.

The Ecology of Antihypertensives in the United States, 1997-2017.

OBJECTIVE: Antihypertensives are the most used medication type in the USA, yet there remains uncertainty about the use of different antihypertensives. We sought to characterize use of antihypertensives by and within medication class(es) between 1997 and 2017. PATIENTS AND METHODS: A repeated cross-sectional study of 493,596 adult individuals using the 1997-2017 Medical Expenditure Panel Survey (MEPS). The Orange Book was used for adjunctive information. The primary outcome was the estimated use by and within antihypertensive medication class(es). RESULTS: The proportion of individuals taking any antihypertensive during a year increased from 1997 to the early 2010s and then remained stable. The proportion of adults using angiotensin II receptor blockers (ARBs) and dihydropyridine calcium channel blockers (CCBs) increased during the study period, while angiotensin-converting enzyme inhibitors (ACE-Is) increased until 2010 after which rates remained stable. Beta-blocker use was similar to that of ACE-Is with an earlier decline starting in 2012. Thiazide diuretic use increased from 1997 to 2007, leveled off until 2014, and declined from 2015 to 2017. Non-dihydropyridine CCB use declined throughout the study. ACE-Is, ARBs, CCBs, thiazide diuretics, and loop diuretics all had one dominant in-class medication. There was a clear increase in the use of losartan within ARBs, lisinopril within ACE-Is, and amlodipine within CCBs following generic conversion. Furosemide and hydrochlorothiazide started with and maintained a dominant position in their classes. Metoprolol use increased throughout the study and became the dominant beta-blocker. CONCLUSIONS: Antihypertensive classes appear to have a propensity to equilibrate to an individual medication, despite a lack of outcomes-based research to compare medications within a class.

Decreasing Use of Primary Care: A Repeated Cross-Sectional Study of MEPS 2007-2017.

We sought to describe the proportion of patients in contact with a primary care physician, as well as the total number of primary care contacts over a 2-year period, using the 2002-2017 Medical Expenditure Panel Survey. The rate of any contact with a primary care physician for patients in the population decreased by 2.5% over the study period (adjusted odds ratio [aOR] = 0.99 per panel, 95% CI, 0.98-0.99; P <.001). The number of contacts with a primary care physician decreased among individuals with any contact by 0.5 contacts over 2 years (aOR = -0.04 per panel, 95% CI, -0.04 to -0.03, P <.001). The decreases were observed across all age groups at varying rates. The results of this study suggest that the driver for the previously reported decreases in primary care visits is secondary to fewer contacts per patient.

Informed consent for invasive procedures in the emergency department.

BACKGROUND: Informed consent for procedures in the emergency department (ED) challenges practitioners to navigate complex ethical and medical ambiguities. A patient's altered mental status or emergent medical problem does not negate the importance of his or her participation in the decision-making process but, rather, necessitates a nuanced assessment of the situation to determine the appropriate level of participation. Given the complexities involved with informed consent for procedures in the ED, it is important to understand the experience of key stakeholders involved. METHODS: For this review, we searched Medline, the Cochrane database, and Clinicaltrials.gov for studies involving informed consent in the ED. Inclusion and exclusion criteria were designed to select for studies that included issues related to informed consent as primary outcomes. The following data was extracted from included studies: Title, authors, date of publication, study type, participant type (i.e. adult patient, pediatric patient, parent of pediatric patient, patient's family, or healthcare provider), number of participants, and primary outcomes measured. RESULTS: Fifteen articles were included for final review. Commonly addressed themes included medical education (7 of 15 studies), surrogate decision-making (5 of 15 studies), and patient understanding (4 of 15 studies). The least common theme addressed in the literature was community notification (1 of 15 studies). CONCLUSIONS: Studies of informed consent for procedures in the ED span many aspects of informed consent. The aim of the present narrative review is to summarize the work that has been done on informed consent for procedures in the ED.

Financial Conflicts of Interest Among Emergency Medicine Journals' Editorial Boards.

STUDY OBJECTIVE: We aim to characterize the prevalence of financial conflicts of interest among emergency medicine journal editorial board members. METHODS: We conducted a cross-sectional study of editorial board members of leading peer-reviewed emergency medicine journals. A list of highly cited emergency medicine journals was curated with Journal Citation Reports and Google Scholar Metrics. Financial conflicts of interest were obtained by curating the Centers for Medicare & Medicaid Services' Open Payments database for the most recently available data (2017). The outcomes of this study were prevalence of financial conflicts of interest and frequency of disclosure on each journal's Web site. RESULTS: Editorial boards of the top 5 journals were analyzed. Of the 198 unique US-based physician-editors, 60 (30.3%) had a financial conflict of interest documented as general or research-based payments. The 52 editors with general payments had a median of 2 payments (interquartile range [IQR] 1 to 8.25), with a median of $202 (IQR $69 to $7,386); the maximum general payment was $115,730 received from industry. For research payments, 26 editors (13.1%) had a median 4 payments (IQR 2 to 9), with a median of $47,095 (IQR $5,328 to $126,025) and maximum of $3,590,000 received from industry. Seven editors in one of the emergency medicine journals included in this study publicly disclosed competing interests; dollar amounts were not reported. CONCLUSION: Nearly one third of US-based editors at leading emergency medicine journals had financial conflicts of interest, although only one journal publicly disclosed the presence of payments. Public disclosure of editorial board members' financial relationships with industry may allow for more transparency related to the content published in these journals.

Public interest in gun control in the USA.

To characterise public interest in gun control in the USA using internet search queries, we undertook a cross-sectional study of the relative popularity Google Trends searchers for 'Gun Control', 'Second Amendment', 'National Rifle Association' and 'Mass Shooting' from May 2015 to December 2018. 740 weeks of data were queried. Graphed data revealed nine major inflection points. Seven of the nine (78%) major inflection points were associated with mass shootings, while two of the nine (22%) were related to political events by either the president of the USA or a presidential candidate. Our exploration of Google Trends shows the frequency of national searches related to gun control peaks with mass shootings over a 1-2-week period and then stabilises to nominal relative popularity thereafter suggesting a need to engage the public on gun control during 'trough' periods in order to sustain national interest and dialogue.

Financial relationships with industry among guideline authors for the management of acute ischemic stroke.

OBJECTIVE: To characterize the prevalence of industry relationships among authors of acute ischemic stroke (AIS) guidelines and its association with graded evidence. METHODS: A cross-sectional study of five policy papers on AIS published by the American Heart Association (AHA)/American Stroke Association (ASA), American Academy of Emergency Physicians (AAEM), and American College of Emergency Physicians (ACEP). Financial conflicts of interest (FCOI) data were obtained using the Open Payments Database for the years 2013 through 2017. A search of publicly available information was done to determine post-guideline employment. We characterized the prevalence of FCOI, as well as employment with industry engaged in thrombolysis or neurointerventional treatment of AIS after guideline publication. RESULTS: 76 unique authors were identified in 5 policy statements. The prevalence of FCOI among authors of AAEM, ACEP, and AHA/ASA guidelines was 0%, 0%, and 35%, respectively. Post-publication increase in FCOI was 0% for authors of the AAEM and ACEP guidelines, and a 300% increase for authors of the 2013 AHA/ASA guidelines with data unavailable to assess post-publication FCOI for authors of the 2018 AHA/ASA guidelines. 2 authors were found to engage in new industry employment following recommendation publication. Finally, 9% (n = 3) authors of the 2013/2018 AHA/ASA guidelines were employees of the Genentech Speakers Bureau. CONCLUSIONS: Our results suggest an association between current Graded Evidence and FCOI of major academic societies for the management of AIS. Due to the bias inherent to such conflicts, future recommendation groups should take steps to insulate against FCOI both during and following guideline publication.

Analysis of current financial relationships between emergency physicians and industry.

OBJECTIVE: Characterize the frequency and magnitude of all categories of publicly reported financial payments made to emergency physicians (EPs) in the United States (U.S.) in 2017. METHODS: This cross-sectional study of the 2017 Centers for Medicare and Medicaid Services Open Payments Database was exempt from Institutional Review Board Review. We calculated descriptive statistics of the frequency, type, and amount (medians) of general, research, and ownerships transactions made to EPs from industry, described regional differences of median payments to EPs, and characterized the drugs or devices most commonly associated with transactions. RESULTS: In 2017, among 40,899 practicing U.S. EPs, 14,447 (35.4%) received 51,870 general payments from industry totaling $12,870,832. The median per-physician payment was $18.30 (interquartile range [IQR], $13.63-$60.90). The most frequent transaction was food and beverage (89.6%), though most payments by dollar amount were related to speaker and consulting fees (74.5%). Antithrombotics were the most frequently drug or device associated with transactions. Only 35 (0.08%) and 20 (0.05%) EPs had research and ownership relationships with industry, respectively. A significant difference was observed in median payments per physician across all U.S. Census regions (p < 0.01) except when comparing Northeast and West (p = 1.00). CONCLUSIONS: Over one-third of U.S. EPs had general payments from industry in 2017, while <1% of EPs had either research and ownership payments during this time period. Consistent with previous research, most payments to EPs are of low monetary value. Antithrombotics remain the most frequent drug associated with payments to EPs.

The Decent Care Movement: Subsidiarity, Pragmatic Solidarity, and Cross-Cultural Resonance.

Decent Care is the World Health Organization and The Ford Foundation's joint effort to articulate a healthcare paradigm that makes a patient's voice equal to the voice of the healthcare provider. In this article, the six tenants of Decent Care are outlined with particular emphasis on subsidiarity. Liberation theology's preferential option for the poor maxim is presented and compared with other major world religions to demonstrate the cross-cultural focus of "decency." The power of this paradigm is in its emphasis and proclamation of human flourishing in a healthcare setting, generally speaking, and more specifically, human flourishing in the presence of affliction from chronic disease or dying cross-culturally.