Reporting of Complications in Rhinoplasty Randomized Controlled Trials: An Analysis Using the CONSORT Extension for Harms Checklist.

OBJECTIVE: This study aimed to assess the completeness of adverse event (AE) reporting in randomized control trials (RCTs) focused on rhinoplasty, using the Consolidated Standards for Reporting (CONSORT) Extension for Harms checklist. STUDY DESIGN: A cross-sectional design was employed to review RCTs related to rhinoplasty published between January 1, 2005, and January 28, 2022. SETTING: The study analyzed clinical trials on rhinoplasty retrieved from PubMed. METHODS: We performed a comprehension search on PubMed, blind and duplicate screening, and data extraction. Adherence to the 18 recommendations of the CONSORT Extension for Harms was evaluated, with 1 point assigned for each adhered item. Percent adherence was calculated based on the 18 points, taking into account the multiple subcategories within some recommendations. Descriptive statistics were used to summarize adherence-including frequencies, percentages, and 95% confidence intervals. RESULTS: Our search returned 240 articles, of which 56 met inclusion criteria. No RCTs adhered to all 18 CONSORT Extension for Harms items. Twenty-six (26/56, 46.4%) adhered to ≥50% of the items, and 30 (30/56, 53.6%) adhered to ≥33.3% of the items. Seven (7/56, 12.5%) RCTs adhered to no items. Across all RCTs, the average number of CONSORT-Harms items adhered to was 7.2 (7.2/18, 40.0%). The most adhered to item was item 10. Discussion balanced with regard to efficacy and AEs (80.4%, [70.0-90.8]). CONCLUSION: This study highlights the inadequacy of AE reporting in rhinoplasty RCTs according to CONSORT-Harms guidelines. Urgent efforts are required to bridge this reporting gap and enhance transparency in surgical research, ultimately safeguarding patient well-being.

Enhanced recovery after cardiac surgery: A literature review.

Enhanced recovery after cardiac surgery (ERACS) represents a constellation of evidence-based peri-operative methods aimed to reduce the physiological and psychological stress patients experience after cardiac surgery, with the primary objective of providing an expedited recovery to pre-operative functional status. The method involves pre-operative, intra-operative, and post-operative interventions as well as direct patient engagement to be successful. Numerous publications in regard to the benefits of enhanced recovery have been presented, including decreased post-operative complications, shortened length of stay, decreased overall healthcare costs, and higher patient satisfaction. Implementing an ERACS program undeniably requires a culture change, a methodical shift in the approach of these patients that ultimately allows the team to achieve the aforementioned goals; therefore, team-building, planning, and anticipation of obstacles should be expected.

Fertility preservation choices and decisional regret after gender-affirming surgery in transgender men or gender nonbinary persons.

Objective: To investigate the prevalence of decisional regret regarding preoperative fertility preservation choices after gender-affirming surgery or removal of reproductive organs. Design: Cross-sectional. Setting: University-based pratice. Patients: A total of 57 survey respondents identifying as transgender men or gender nonbinary with a history of gender-affirming surgery or removal of reproductive organs between 2014 and 2023 with the University of North Carolina Minimally Invasive Gynecology division. Intervention: Survey or questionnaire. Main Outcome Measures: The prevalence and severity of decisional regret regarding preoperative fertility preservation choices were measured with the use of the validated decisional regret scale (DRS) (scored 0-100). Secondary outcomes included patient-reported barriers to pursuing reproductive endocrinology and infertility consultation and fertility preservation treatment. Results: The survey response rate was 50.9% (57/112). "Mild" to "severe" decisional regret was reported by 38.6% (n = 22) of survey respondents, with DRS scores among all respondents ranging from 0-85. Higher median DRS scores were associated with patient-reported inadequacy of preoperative fertility counseling regarding implications of surgery on future fertility or family-building (0 vs. 50) and fertility preservation options (0 vs. 12.5). No desire for future fertility at the time of fertility counseling was the most frequent reason (68.4%) for declining a referral to reproductive endocrinology and infertility for additional fertility preservation discussion. Conclusions: Decisional regret regarding preoperative fertility preservation choices is experienced among transgender men or gender nonbinary persons after gender-affirming surgery or the removal of reproductive organs. Preoperative, patient-centered fertility counseling and fertility preservation treatments should be provided to reduce the risk of future regret.

MAN VERSUS MACHINE: PROVIDER DIRECTED VERSUS PRECISION AUTOMATED CRITICAL CARE MANAGEMENT IN A PORCINE MODEL OF DISTRIBUTIVE SHOCK.

ABSTRACT: Background: Critical care management of shock is a labor-intensive process. Precision Automated Critical Care Management (PACC-MAN) is an automated closed-loop system incorporating physiologic and hemodynamic inputs to deliver interventions while avoiding excessive fluid or vasopressor administration. To understand PACC-MAN efficacy, we compared PACC-MAN to provider-directed management (PDM). We hypothesized that PACC-MAN would achieve equivalent resuscitation outcomes to PDM while maintaining normotension with lower fluid and vasopressor requirements. Methods : Twelve swine underwent 30% controlled hemorrhage over 30 min, followed by 45 min of aortic occlusion to generate a vasoplegic shock state, transfusion to euvolemia, and randomization to PACC-MAN or PDM for 4.25 h. Primary outcomes were total crystalloid volume, vasopressor administration, total time spent at hypotension (mean arterial blood pressure <60 mm Hg), and total number of interventions. Results : Weight-based fluid volumes were similar between PACC-MAN and PDM; median and IQR are reported (73.1 mL/kg [59.0-78.7] vs. 87.1 mL/kg [79.4-91.8], P = 0.07). There was no statistical difference in cumulative norepinephrine (PACC-MAN: 33.4 µg/kg [27.1-44.6] vs. PDM: 7.5 [3.3-24.2] µg/kg, P = 0.09). The median percentage of time spent at hypotension was equivalent (PACC-MAN: 6.2% [3.6-7.4] and PDM: 3.1% [1.3-6.6], P = 0.23). Urine outputs were similar between PACC-MAN and PDM (14.0 mL/kg vs. 21.5 mL/kg, P = 0.13). Conclusion : Automated resuscitation achieves equivalent resuscitation outcomes to direct human intervention in this shock model. This study provides the first translational experience with the PACC-MAN system versus PDM.

Data-Sharing Across Otolaryngology: Comparing Journal Policies and Their Adherence to the FAIR Principles.

OBJECTIVE: Data-sharing plays an essential role in advancing scientific understanding. Here, we aim to identify the commonalities and differences in data-sharing policies endorsed by otolaryngology journals and to assess their adherence to the FAIR (findable, accessible, interoperable, reusable) principles. METHODS: Data-sharing policies were searched for among 111 otolaryngology journals, as listed by Scimago Journal & Country Rank. Policy extraction of the top biomedical journals as ranked by Google Scholar metrics were used as a comparison. The FAIR principles for scientific data management and stewardship were used for the extraction framework. This occurred in a blind, masked, and independent fashion. RESULTS: Of the 111 ranked otolaryngology journals, 100 met inclusion criteria. Of those 100 journals, 79 provided data-sharing policies. There was a clear lack of standardization across policies, along with specific gaps in accessibility and reusability which need to be addressed. Seventy-two policies (of 79; 91%) designated that metadata should have globally unique and persistent identifiers. Seventy-one (of 79; 90%) policies specified that metadata should clearly include the identifier of the data they describe. Fifty-six policies (of 79; 71%) outlined that metadata should be richly described with a plurality of accurate and relevant attributes. CONCLUSION: Otolaryngology journals have varying data-sharing policies, and adherence to the FAIR principles appears to be moderate. This calls for increased data transparency, allowing for results to be reproduced, confirmed, and debated.

Selective reprogramming of regulatory T cells in solid tumors can strongly enhance or inhibit tumor growth.

Folate receptor delta (FRδ) has been used as a biomarker for regulatory T cells (Tregs), because its expression is limited to Tregs and ovum. Although FRδ is unable to bind folate, we have used molecular docking software to identify a folate congener that binds FRδ with high affinity and have exploited this FRδ-specific ligand to target attached drugs (imaging agents, immune activators, and immune suppressors) specifically to Tregs in murine tumor xenografts. Analysis of treated tumors demonstrates that targeting of a Toll-like receptor 7 agonist inhibits Treg expression of FOXP3, PD-1, CTLA4, and HELIOS, resulting in 40-80% reduction in tumor growth and repolarization of other tumor-infiltrating immune cells to more inflammatory phenotypes. Targeting of the immunosuppressive drug dexamethasone, in contrast, promotes enhanced tumor growth and shifts the tumor-infiltrating immune cells to more anti-inflammatory phenotypes. Since Tregs comprise <1% of cells in the tumor masses examined, and since the targeted drugs are not internalized by cancer cells, these data demonstrate that Tregs exert a disproportionately large effect on tumor growth. Because the targeted drug did not bind to Tregs or other immune cells in healthy tissues, the data demonstrate that the immunosuppressive properties of Tregs in tumors can be manipulated without causing systemic toxicities associated with global reprogramming of the immune system.

Characteristics of school psychology faculty in 2021.

Although racial, ethnic, and linguistically minoritized school-aged students within the United States are increasing in population, school psychologists have historically been predominantly white, monolingual females. Diversity within the field of school psychology is important for improving students' achievement and postsecondary success, particularly as it relates to underrepresented students. Research shows that the diversity of school psychology faculty is important for the recruitment and retention of minoritized graduate students. However, demographic information within school psychology has only been calculated within the context of memberships to psychological organizations (e.g., the National Association of School Psychologists), which could underestimate the actual diversity of school psychology faculty currently in the profession. The purpose of this study was to collect information on the demographic characteristics of school psychology faculty as of 2021. A total of 429 school psychology trainers completed a brief web-based survey in which they self-identified their employment characteristics, gender identity, sexual orientation, racial-ethnic identity, (dis)ability status, and languages spoken. At the time of the survey, most of the sample were employed as full professors (30.5%) or assistant professors (29.4%). Results demonstrated that majority of the sample identified as white (78.6%), cisgender female (66.2%), heterosexual (87.2%), non(dis)abled (95.1%), and monolingual English speaking (83.9%). Faculty of color were more likely to report a higher percentage of time spent teaching as compared to white faculty. Implications of these findings and future directions are discussed. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Feasibility and acceptability of an mHealth, home-based exercise intervention in colorectal cancer survivors: A pilot randomized controlled trial.

OBJECTIVE: To determine the feasibility and acceptability of an mHealth, home-based exercise intervention among stage II-III colorectal cancer (CRC) survivors within 5-years post-resection and adjuvant therapy. METHODS: This pilot randomized controlled trial of a 12-week mHealth, home-based exercise intervention, randomly assigned CRC survivors to a high-intensity interval training (HIIT) or moderate-intensity continuous exercise (MICE) prescription. The following assessments were carried out at baseline and end-of-study (EOS): handgrip strength, short physical performance battery (SPPB), PROMIS physical function, neuropathy total symptom score-6 (NTSS-6), Utah early neuropathy scale (UENS), cardiopulmonary exercise testing, anthropometrics, and body composition via BOD POD, modified Godin leisure-time activity questionnaire. Feasibility, as defined by number of completed prescribed workouts and rate of adherence to individualized heart rate (HR) training zones, was evaluated at EOS. Acceptability was assessed by open-ended surveys at EOS. Descriptive statistics were generated for participant characteristics and assessment data. RESULTS: Seven participants were included in this pilot study (MICE: n = 5, HIIT: n = 2). Median age was 39 years (1st quartile: 36, 3rd quartile: 50). BMI was 27.4 kg/m2 (1st quartile: 24.5, 3rd quartile: 29.7). Most participants had stage III CRC (71%, n = 5). We observed an 88.6% workout completion rate, 100% retention rate, no adverse events, and qualitative data indicating improved quality of life and positive feedback related to ease of use, accountability, motivation, and autonomy. Mean adherence to HR training zones was 95.7% in MICE, and 28.9% for the high-intensity intervals and 51.0% for the active recovery intervals in HIIT; qualitative results revealed that participants wanted to do more/work-out harder. CONCLUSION: An mHealth, home-based delivered exercise intervention, including a HIIT prescription, among stage II-III CRC survivors' post-resection and adjuvant therapy was tolerable and showed trends towards acceptability.

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.

Discontinuation and nonpublication analysis of chronic pain randomized controlled trials.

Introduction: The primary objective of this cross-sectional analysis is to evaluate rates of discontinuation and nonpublication of Randomized controlled trials (RCTs) of therapeutic interventions to treat chronic pain. Methods: Using ClinicalTrials.gov, a sample was obtained which included clinical trials pertaining to chronic pain. Trials were analyzed for publication status and completion status of each trial. If information was unavailable on the trial registry database, or could not be allocated through a systematic search, the corresponding trialist was contacted and data points were gathered. Results: In our final analysis of the 408 RCTs, we found that 281 (68.9%) were published in a peer-reviewed journal and 127 (31.1%) were unpublished trials. Of 112 discontinued trials, 59 (52.7%) reached publication. In addition, 221 of 296 completed trials (74.7%) were published, and 75 (25.3%) remained unpublished after trial completion. The most common listed reason for trial discontinuation was administrative recommendations (41 of 71 trials [57.7%]), while not receiving an email reply to our standardized email from the corresponding trialist was the most common result for trial nonpublication (49 of 88 trials [55.7%]). Clinical trials funded by nonindustry sponsors were more likely to reach publication than industry-funded clinical trials (unadjusted odds ratio 1.86 [95% CI, 1.18-2.95]; adjusted odds ratio 3.01 [95% CI, 1.76-5.14]). Conclusion: The rate of discontinuation of RCTs involving patients with chronic pain is concerning. Chronic pain affects many patients; thus, the importance of having quality data from clinical trials cannot be overstated. Our study indicates that chronic pain RCTs are frequently discontinued and their findings often go unpublished - all of which could provide crucial information to providers and patients regarding the treatment of chronic pain. We offer suggestions to enhance chronic pain RCT completion, thereby reducing the waste of resources in chronic pain research.

Single-case intervention research design standards: Additional proposed upgrades and future directions.

Single-case intervention research design standards have evolved considerably over the past decade. These standards serve the dual role of assisting in single-case design (SCD) intervention research methodology and as guidelines for literature syntheses within a particular research domain. In a recent article (Kratochwill et al., 2021), we argued for a need to clarify key features of these standards. In this article we offer additional recommendations for SCD research and synthesis standards that have been either underdeveloped or missing in the conduct of research and in literature syntheses. Our recommendations are organized into three categories: expanding design standards, expanding evidence standards, and expanding the applications and consistency of SCDs. The recommendations we advance are for consideration for future standards, research design training, and they are especially important to guide the reporting of SCD intervention investigations as they enter the literature-synthesis phase of evidence-based practice initiatives.

Harms reporting by systematic reviews for functional endoscopic sinus surgery: a cross-sectional analysis.

OBJECTIVES: To evaluate the completeness of harms reporting in systematic reviews (SRs) pertaining to functional endoscopic sinus surgery (FESS). METHODS: Using a cross-sectional study design, we performed a comprehensive search using MEDLINE (PubMed and Ovid), EMBASE, Epistemonikos, and the Cochrane Database of Systematic Reviews databases for SRs regarding FESS on May 15th, 2022. Returns were screened and data were extracted in a masked, duplicate manner. Following established methodology, we extracted general study characteristics, harms items, and overall methodological quality for each SR in our sample. Corrected covered area (CCA) was calculated for SR dyads. For data analysis, using Stata 16.1 we performed a bivariate analysis between variables. RESULTS: Fifty-five SR's were included in our sample after excluding 375 studies that did not meet our inclusion criteria. Of the included SRs, 19 (19/55, 34.5%) did not report harms and 39 (39/55, 70.9%) reported half of the harms items or fewer. Our study found that 23 (23/55, 41.8%) of SRs demonstrated a method of harms data collection, 26 (26/55, 47.3%) of SRs had patients available for harms analysis in their results, and 25 (25/55, 45.5%) of SRs had a balanced discussion of harms and benefits of FESS. Fifty-two SRs were appraised as "critically low" quality using AMSTAR-2. A significant association was found between completeness of harms reporting (Mahady) and whether harms were listed as a primary outcome. No other associations were statistically significant. Two SR dyads had CCAs between 20% and 50% overlap and were compared for unique and shared harms. CONCLUSIONS: Our study demonstrates gaps in harms reporting regarding FESS in SRs. We recommend future studies implement guidelines such as the STROCCS guidelines or the harms extension of the PRISMA guidelines to improve harms reporting. Accurate harms reporting may advance patient safety and promote a more objective risk-benefit analysis for physicians and patients.

Clinical trial data-sharing policies among journals, funding agencies, foundations, and other professional organizations: a scoping review.

BACKGROUND AND OBJECTIVES: To identify the similarities and differences in data-sharing policies for clinical trial data that are endorsed by biomedical journals, funding agencies, and other professional organizations. Additionally, to determine the beliefs, and opinions regarding data-sharing policies for clinical trials discussed in articles published in biomedical journals. METHODS: Two searches were conducted, a bibliographic search for published articles that present beliefs, opinions, similarities, and differences regarding policies governing the sharing of clinical trial data. The second search analyzed the gray literature (non-peer-reviewed publications) to identify important data-sharing policies in selected biomedical journals, foundations, funding agencies, and other professional organizations. RESULTS: A total of 471 articles were included after database search and screening, with 45 from the bibliographic search and 426 from the gray literature search. A total of 424 data-sharing policies were included. Fourteen of the 45 published articles from the bibliographic search (31.1%) discussed only advantages specific to data-sharing policies, 27 (27/45; 60%) discussed both advantages and disadvantages, and 4 (4/45; 8.9%) discussed only disadvantages specific. A total of 216 journals (of 270; 80%) specified a data-sharing policy provided by the journal itself. One hundred industry data-sharing policies were included, and 32 (32%) referenced a data-sharing policy on their website. One hundred and thirty-six (42%) organizations (of 327) specified a data-sharing policy. CONCLUSION: We found many similarities listed as advantages to data-sharing and fewer disadvantages were discussed within the literature. Additionally, we found a wide variety of commonalities and differences-such as the lack of standardization between policies, and inadequately addressed details regarding the accessibility of research data-that exist in data-sharing policies endorsed by biomedical journals, funding agencies, and other professional organizations. Our study may not include information on all data sharing policies and our data is limited to the entities' descriptions of each policy.

TEE guided REBOA deflation following ROSC for non-traumatic cardiac arrest.

Resuscitative endovascular balloon occlusion of the aorta (REBOA) is most commonly used to manage non-compressible torso hemorrhage. It is also emerging as a promising treatment for non-traumatic refractory cardiac arrest. Aortic occlusion during chest compressions increases cardio-cerebral perfusion, increasing the potential for sustained return of spontaneous circulation (ROSC) or serving as a bridge to extracorporeal cardiopulmonary resuscitation (ECPR). Optimal patient selection and post-ROSC management in such cases is uncertain and not well reported in the literature. We present a case of non-traumatic out-of-hospital cardiac arrest in which REBOA was placed in the emergency department with subsequent ROSC. Transesophageal echocardiography was used to guide post-ROSC REBOA management and balloon deflation.

An Evaluation of Research Publications for General Surgery Residents And its Influence on the Future Pursuit of Fellowship or Academic Career.

INTRODUCTION: 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, the rate of research outcomes among general surgery residents remains unknown. Our study aims to determine associated factors that influence publication rates before, during, and after general surgery residency. METHODS: This observational study employed a cross-sectional design. We examined whether research outcomes during general surgery residency was associated with academic advancement or continued research involvement after residency. We identified 321 general surgery 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 405 residency 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: Among the 405 physicians analyzed, 3815 total publications were identified with a mean of 9.4 (SD 11.8) per person. The most reported study design was observational studies (46.5%; 1775/3815) and the least reported was systematic reviews/meta-analyses (1.4%; 52/3815). The number of publications before residency positively correlated with having a higher h-index (r = 0.4). We also found that physicians who completed a fellowship had more publications during residency (mean = 4.7, SD = 6.5) than those not pursuing a fellowship (mean = 1.5, SD = 2.7; t= -4.3. p ≤ 0.001). We observed a statistically significant increase in the likelihood a physician pursued a career in academic medicine if they pursued a fellowship (OR: 3.77, 95% CI: 2.0-7.2) and if they had published research as a primary author (OR 1.25, 95% CI: 1.0-1.5). CONCLUSION: Increased research productivity was associated with continued academic pursuits and an increased likelihood of pursuing fellowship training after residency.

Understanding preferences of general educators for supporting classwide behavior.

Innovations, such as novel evidence-based practices, are not likely to diffuse to practice without explicit effort and design (Rogers, 2003). In an effort to understand how interventions should be designed to meet teacher preferences, the present study utilized a full-profile two-alternative forced-choice experiment to examine teacher preferences when selecting a classwide intervention to address student disruptive behavior. Attributes and levels for the experiment were derived in response to four characteristics from Rogers' diffusion of innovations theory. Results from 266 general education teachers of Grades K-5 indicated that nearly all theorized characteristics influenced teacher preference, with the exception of the observability of the intervention (i.e., receiving feedback from others). Specific findings of levels within attributes suggest that, for instance, short online video trainings are preferable to full-day workshops and specific details on adaptations for inclusivity are highly preferred. Given school psychologists' roles in consultation and behavior support, knowledge of teacher preferences may be utilized to support intervention uptake and more general dissemination efforts. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

"We Already Knew What Time It Was:" HIV, COVID19, and Black Transgender Women in the South.

Black transgender women in the Southeast are at the center of the modern-day HIV crisis in the U.S. This focus group study was aimed at understanding the impacts of the COVID-19 pandemic on the health and well-being of Black transgender women in the U.S. Southeast who are affected by HIV. From April-June 2022, we completed seven focus group interviews with 56 participants. Themes identified across the focus groups show: 1) the challenges that pre-dated COVID-19; 2) the challenges of managing COVID-19 risk; 3) negative consequences for mental health, physical health, and overall well-being; 4) negative trends in coping with pandemic stress; 5) the importance of self-care and social support for managing pandemic stress; and 6) the need for more community-based resources. Findings demonstrate that understanding these social determinants of health is vital to developing support resources in this ongoing health crisis and crises yet to come.

Correction to: The weight of harm: A Response to "Editor's Note: Societal changes and expression of concern about Rekers and Lovaas' (1974) Behavioral Treatment of Deviant Sex-Role Behaviors in a Male Child".

[This corrects the article DOI: 10.1007/s40617-022-00683-y.].