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.

Mpox-associated supraglottitis in an immunocompetent, reportedly sexually abstinent child.

Mpox is a double-stranded DNA virus of the Orthopoxvirus genus related to smallpox virus endemic to Africa with more than 16,000 cases reported in nonendemic countries in 2022. Classically associated with adult men who have sex with men (MSM), Mpox was once labeled a public health emergency by the World Health Organization as concerning to the general population. Supraglottitis is a rare complication of Mpox that is underreported in the literature and presents a potential airway emergency. Prompt identification is necessary for preventing airway decompensation.

Ameloblastic Carcinoma of the Maxilla With Uncommon Sinus Manifestations.

Ameloblastic carcinoma (AC) represents a distinct challenge in the realm of odontogenic malignancies due to its rarity and aggressive nature. We present a unique case of AC in a 70-year-old male, retired dry cleaner, with symptoms initially suggestive of chronic allergic rhinitis and recurrent acute sinusitis with asymmetric facial edema and paresthesia. Detailed evaluation revealed a prominent mass in the right maxillary sinus with extensive cortical destruction. Pathological assessment post-right maxillectomy identified a high-grade AC with malignant spindle cell transformation. The patient underwent subsequent interventions, including neck dissection and radiation therapy. Twelve months post-presentation, the patient was recovering appropriately without evidence of recurrence of malignancy. This case highlights the diagnostic challenges posed by AC as well as its unique presentations emphasizing the importance of a comprehensive approach and multidisciplinary management. It also raises considerations about potential chemical exposure implications in AC development.

Effect of Electronic Portal Messaging With Embedded Asynchronous Care on Physician-Assisted Smoking Cessation Attempts: A Randomized Clinical Trial.

IMPORTANCE: Despite the substantial health and financial burdens of smoking and the availability of effective, evidence-based interventions in primary care settings, few smokers and physicians use these strategies for smoking cessation. OBJECTIVE: To evaluate whether electronic outreach to smokers with embedded asynchronous care increases the number of quit attempts and explore the roles of the message sender (ie, primary care physician [PCP] vs health care system) and patient-related characteristics. DESIGN, SETTING, AND PARTICIPANTS: This quality improvement randomized clinical trial was designed to measure 2 factors: (1) electronic outreach messaging with and without a survey link to asynchronous care and (2) messaging by a personal PCP or health system. The study was conducted within the electronic health record and portal messaging platform of a large health system in the South Central US. Participants were adult patients 18 years or older who were designated as smokers in their electronic health records. Data were collected from January 13 to February 24, 2020, with participating PCPs surveyed in July 2020. INTERVENTIONS: Portal messages encouraging a quit attempt and offering physician assistance were sent to smokers who were randomly selected and assigned to 1 of 4 conditions (message with or without embedded asynchronous care and PCP or system as sender). Half of the messages contained an invitation to come to clinics and the other half contained a link to access asynchronous care. MAIN OUTCOMES AND MEASURES: The primary outcome was electronic health record-documented quit attempts (1 indicates quit attempt; 0, no quit attempt), which were tracked 30 days after the electronic outreach. Secondary outcomes included physician perceptions of the electronic outreach intervention, using a 5-point scale to assess perceptions of workload, comfort with providing medication from survey information, and further interest in the program 6 months after the intervention. RESULTS: A total of 188 participants (99 women [52.4%] and 89 men [47.3%]) with mean (SD) age of 55.2 (13.9) years were randomized to 1 of 4 conditions. Group 1 (n = 46) received a message from the PCP without a link to the survey; group 2 (n = 48) received a message from the PCP with a link to asynchronous care in the form of the survey. Group 3 (n = 47) received a message from the health system without a link to the survey; group 4 (n = 47) received a message from the health system with a link to the survey. No statistically significant difference in documented quite attempts was found among the 4 study groups. There was also no statistically significant difference in quit attempts between the group that received the asynchronous care survey link and the group that did not (odds ratio, 2.50 [95% CI, 0.72-8.72]). However, the quit attempt rate for those with asynchronous care offered (9 of 95 [9.5%]) was more than double the quit attempt rate for those with in-person care offered (4 of 93 [4.3%]). CONCLUSIONS AND RELEVANCE: This quality improvement randomized clinical trial did not find a statistically significant difference in physician-assisted quit attempts among patients who received electronic with asynchronous care vs those who received outreach alone, regardless of whether the message source was a PCP or a health system. However, the program engaged patients in difficult-to-reach rural areas as well as younger patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05172219.

Exuberant Arytenoid Edema Following Gore-Tex Thyroplasty.

Arytenoid edema is not a well-described complication of thyroplasty. We report a case of exuberant arytenoid edema following thyroplasty in a 33-year-old female. The diagnosis was made post-operative day 1, the patient was immediately started on a 6-day course of methylprednisone with voice rest. The arytenoid edema completely resolved within 1 week.

An evaluation of the practice of transparency and reproducibility in addiction medicine literature.

BACKGROUND: Credible research emphasizes transparency, openness, and reproducibility. These characteristics are fundamental to promoting and maintaining research integrity. The aim of this study was to evaluate the current state of reproducibility in the field of addiction science. DESIGN: Cross-sectional design. MEASUREMENTS: The National Library of Medicine catalog was searched for all journals using the subject terms tag: Substance-Related Disorders [ST]. Journals were then searched via PubMed to identify publications from January 1, 2014, to December 31, 2018; 300 publications were randomly selected from among those identified. A pilot-tested Google form containing reproducibility/transparency characteristics was used for data extraction in a duplicated and blinded fashion by two investigators. FINDINGS: Slightly more than half of the publications were open access (152/300, 50.70%). Few publications had pre-registration (7/244, 2.87%), material availability (2/237, 0.84%), protocol availability (3/244, 1.23%), data availability (28/244, 11.48%), or analysis script availability (2/244, 0.82%). Most publications provided a conflict of interest statement (221/293, 75.43%) and funding sources (268/293, 91.47%). One replication study was reported (1/244, 0.4%). CONCLUSION: Our study found that current practices that promote transparency and reproducibility are lacking, thus, there is room for improvement. In particular, investigators should pre-register studies prior to commencement. Researchers should also make the materials, data, and analysis script publicly available. Further, individuals should be transparent about funding sources for the project and financial conflicts of interest. Research stakeholders should work together toward improvements on these matters. With such protections, the field of addiction medicine can better disseminate the information necessary to treat patients.

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.

Discontinuation and nonpublication of pediatric otolaryngology clinical trials.

OBJECTIVES: Randomized controlled trial (RCT) discontinuation and nonpublication are potential mechanisms of waste in resources and lead to decreased advancement of medical science and compromised ethical issues in all specialties. However, the prevalence of discontinued or unpublished RCTs regarding common pediatric otolaryngology disorders and interventions remains unclear. STUDY DESIGN: Cross-sectional analysis. METHODS: Retrospective analysis of common pediatric otolaryngology RCTs registered in ClinicalTrials.gov up until November 2, 2018. Data were collected from the registry, and publication status was identified. If a reason for trial discontinuation or nonpublication was not identified through a systematic search, corresponding trialists were contacted through email. RESULTS: After exclusion, 260 RCTs were included for analysis. Analysis found 198 (76%) RCTs were completed, and 62 (24%) trials were discontinued. The most commonly reported reasons for RCT discontinuation were program termination by sponsor or management (7/24; 29.2%), lack of participant enrollment, difficulty recruiting, or slow accrual (7/24; 29.2%). A total of 192 (192/260; 73.8%) published RCTs and 68 (68/260; 26.2%) unpublished RCTs were identified. Twenty-six (26/62; 42%) of the discontinued RCTs reached publication, while 36 (58%) remained unpublished. Regarding the completed RCTs, 166 of 198 (83.8%) completed trials reached publication, while 32 (32/198; 16.2%) remained unpublished after trial completion. CONCLUSIONS: Approximately 1 in 4 of included RCTs were discontinued or did not reach publication. Findings suggest further guidance is needed for RCTs regarding common pediatric otolaryngology disorders and interventions. LEVEL OF EVIDENCE: NA.