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Surgical implementation gap: An interrupted time series analysis with interviews examining the impact of surgical trials on surgical practice in England
No full textObjectives Landmark studies published near the turn of the 21st century found an implementation gap concerning the effect of evidenced-based findings on clinical practice. The current study examines the uptake of six trials that produced actionable findings to describe the effects of evidence on practice and the reasons for those effects. Design A sequential, explanatory mixed methods study was conducted. First, a quantitative study assessed whether actionable findings from large, publicly funded elective surgical trials influenced practice. Subsequently, qualitative interviews were conducted to explain the quantitative findings. Setting Changes in NHS-funded practice were tracked across hospitals in England. Interviews were conducted online. Data and participants The six surgical trials were funded and published by England\u27s National Institute for Health Research\u27s Health Technology Assessment programme between 2006 and 2015. Quantitative time series analyses used data about the frequencies or proportions of relevant surgical procedures conducted in England between 2001 and 2020. Subsequently, qualitative interviews were conducted with 25 participants including study authors, surgeons and other healthcare staff in the supply chain. Transcripts were coded to identify major temporal events and Consolidated Framework for Implementation Research (CFIR) domains/constructs that could influence implementation. Findings were synthesised by clinical area. Results The quantitative analyses reveal that practice changed in accordance with findings for three trials. In one trial (percutaneous vs nasogastric tube feed after stroke), the change took a decade to occur. In another (patella resurfacing), change anticipated the trial findings. In the third (abdominal aortic aneurysm repair), changes tracked the evolving evidence base. In the remaining trials (two about varicose veins and one about gastric reflux), practice did not change in line with findings. For varicose veins, the results were superseded by a further trial. For gastric reflux, surgical referrals declined as medical treatment increased. The exploratory qualitative analysis informed by CFIR found that evidence from sources apart from the trial in question was mentioned as a reason for non-adoption in the three trials where evidence did not affect practice and in the trial where uptake was delayed. There were no other consistent patterns in the qualitative data. Conclusion While practice does not always change in the direction indicated by clinical trials, our results suggest that individuals, official committees and professional societies do assimilate trial evidence. Decision-makers seem to respond to the totality of evidence such that there are often plausible reasons for not adopting the evidence of any one trial in isolation
Women\u27s preferences for a new contraceptive under development: an exploratory study
No full textObjective: Currently available contraceptive methods do not meet the needs of all users. We sought to explore preferences of potential end-users regarding an on-demand, non-hormonal female contraceptive currently under development, using a web-based survey. Study design: We recruited respondents for an exploratory survey via web link on Amazon Mechanical Turk (MTurk). Individuals were eligible if they were 18–44 years of age, identified as cis-gender female, were English-speaking, not pregnant, and had used barrier contraception previously. Respondents provided demographic characteristics and a basic reproductive history. We then provided a brief description of the potential contraceptive. Respondents were asked about their interest in the proposed contraceptive and preferences for method attributes. Results: A total of 500 respondents completed the survey. Three-quarters of respondents were \u3c35 years of age and 48.2% were currently using a barrier contraceptive method. Three-fourths of respondents (73.8%) expressed interest in using the contraceptive under development. The majority wanted the method to be small (≤2 inches), rod-shaped, and low cost (\u3c$5 per use). More than half (59.4%) said it was important to be able to use the method without partners’ knowledge. The most reported potential concerns were vaginal irritation (51.6%) and lack of effectiveness (46.4%). Sixty percent of respondents were confident they could use the method correctly. Discussion: Available contraceptive methods lack attributes preferred by some users. Development of new contraceptives frequently does not involve end-user input early in the development process. Individuals in this sample displayed interest in the proposed contraceptive and expressed preferences that can inform the further development of this method
2022 ACC/AHA guideline for the diagnosis and management of aortic disease: A report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines
No full textAim: The “2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease” provides recommendations to guide clinicians in the diagnosis, genetic evaluation and family screening, medical therapy, endovascular and surgical treatment, and long-term surveillance of patients with aortic disease across its multiple clinical presentation subsets (ie, asymptomatic, stable symptomatic, and acute aortic syndromes). Methods: A comprehensive literature search was conducted from January 2021 to April 2021, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through June 2022 during the guideline writing process, were also considered by the writing committee, where appropriate. Structure: Recommendations from previously published AHA/ACC guidelines on thoracic aortic disease, peripheral artery disease, and bicuspid aortic valve disease have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with aortic disease have been developed. There is added emphasis on the role of shared decision making, especially in the management of patients with aortic disease both before and during pregnancy. The is also an increased emphasis on the importance of institutional interventional volume and multidisciplinary aortic team expertise in the care of patients with aortic disease
Can guidelines rein in oxygen use? A retrospective cross-sectional study using routinely collected data
No full textOxygen is one of the most commonly used emergency therapies. Like other therapies, oxygen can cause harm if used inappropriately. During the COVID-19 pandemic, guidelines were released to optimize oxygen and medication use. In the current study, we examine whether oxygen and medication use during the first wave of the COVID-19 pandemic was in concordance with new guidelines. A retrospective cross-sectional study was conducted using routinely collected data from University of Birmingham NHS Foundation Trust in England. Patients were admitted between April 2020 and September 2020, were over the age of 18 years, and had a confirmed diagnosis of COVID-19. To assess adherence to the oxygen guidelines (i.e. SpO2 adherence), the percentage of times oxygen therapy was administered within, over, and under guideline specifications were calculated for patients overall, and then for patients with and without chronic obstructive pulmonary disease (COPD)/pulmonary disease separately. Next, two multinomial regression analyses were conducted to assess whether clinical processes, pre-admission diagnoses, and other demographic factors were related to oxygen use. Analysis 1 included patients not diagnosed with COPD/pulmonary disease. Analysis 2 included patients diagnosed with COPD/pulmonary disease. Results are reported as tallies, percentages, and odds ratios with 95% confidence intervals. To assess adherence to a new medication guideline, the percentage of patients administered oxygen and dexamethasone was calculated for those admitted after 25 June 2020. The overall number of patients included in our SpO2 adherence analyses was 8751 (female = 4168). Oxygen was used within guideline specifications less than half the time, i.e. 41.6% (n = 3638/8751); non-adherence involving under-administering (3.5%, n = 304/8751) was markedly lower than over-administering (55.0%, n = 4809/8751). Adherence was higher for patients without COPD (43.7%, n = 3383/7741) than with COPD (25.2%, n = 255/1010). Under-administering was low across groups (non-COPD 3.5%, n = 274/7741 and COPD 2.9%, n = 30/1010). Over-administering was markedly lower for non-COPD (52.3%, n = 4084/7741) than COPD (71.8%, n = 725/1010) patients. Diagnoses associated with over-administering varied across the groups. Regarding the dexamethasone guidelines, of the 6397 patients admitted after the 24th of June, only 12.6% (n = 805) received dexamethasone. Suboptimal use of oxygen and medication were common during the first wave of the COVID-19 pandemic. As found in previous studies, over-administering was more common than under-administering. The new guidelines issued during the COVID-19 pandemic were not by themselves sufficient to optimize oxygen use. Behavioural strategies are explored which may help policymakers optimize oxygen use
International Union of Basic and Clinical Pharmacology CXIII: Nuclear Receptor Superfamily-Update 2023
No full textThe NR superfamily comprises 48 transcription factors in humans that control a plethora of gene network programs involved in a wide range of physiologic processes. This review will summarize and discuss recent progress in NR biology and drug development derived from integrating various approaches, including biophysical techniques, structural studies, and translational investigation. We also highlight how defective NR signaling results in various diseases and disorders and how NRs can be targeted for therapeutic intervention via modulation via binding to synthetic lipophilic ligands. Furthermore, we also review recent studies that improved our understanding of NR structure and signaling. SIGNIFICANCE STATEMENT: Nuclear receptors (NRs) are ligand-regulated transcription factors that are critical regulators of myriad physiological processes. NRs serve as receptors for an array of drugs, and in this review, we provide an update on recent research into the roles of these drug targets
Assigning pathogenicity for TAB2 variants using a novel scalable functional assay and expanding TAB2 disease spectrum
No full textHaploinsufficiency of TGF-beta-activated kinase 1 (MAP3K7) binding protein 2 (TAB2) has been associated with congenital heart disease and more recently multiorgan structural abnormalities. Missense variant represents a major proportion of non-synonymous TAB2 variants reported in gnomAD (295/576) and Clinvar (16/73), most of which are variants of uncertain significance (VUSs). However, interpretation of TAB2 missense variants remains challenging because of lack of functional assays. To address this issue, we established a cell-based luciferase assay that enables high-throughput screening of TAB2 variants to assess the functional consequence for predicting variant pathogenicity. Using this platform, we screened 47 TAB2 variants including five pathogenic controls and one benign control, and the results showed that the transcriptional activity of activator protein 1 (AP-1) but not nuclear factor kappa B predicts the TAB2 variant pathogenicity. This assay provides accurate functional readout for both loss-of-function (LOF) and gain-of-function variants, which are associated with distinct phenotypes. In all, 22 out of 32 tested VUSs were reclassified. Genotype-Phenotype association showed that most patients with partial LOF variants do not exhibit congenital heart disease but high frequency of developmental delay, hypotonia and dysmorphic features, which suggests that genetic testing for TAB2 is needed for a broader spectrum of patients with more diverse phenotypes. Molecular modeling with Npl4 zinc finger (NZF) domain variants revealed that the stability of the NZF domain in TAB2 protein is crucial for AP-1 activation. In conclusion, we developed a highly effective functional assay for TAB2 variant prediction and interpretation
Implementation of an interprofessional education session for postgraduate trainees
No full textPostgraduate residency training provides an opportunity to acquire and apply skills and behaviors learned through interprofessional education (IPE) sessions. Little data exists regarding the perceptions of resident trainees on benefits and barriers of IPE. In this paper, we describe the development and implementation of a case-based IPE activity focused on chronic obstructive pulmonary disease management and inhaler technique in order to explore pharmacy and medicine resident perceptions of IPE. Perceptions of IPE were logged via survey and interviews in parallel with participation in the IPE activity and were analyzed with a constructivist grounded theory approach to identify common themes. Four themes supporting IPE models were found including better understanding of another profession\u27s skills, integration of another profession\u27s skill and perspective to improve patient care, recognition of gaps in expertise, and perception of time and coordination as barriers to learning with other professions. In conclusion, IPE activities improve and advance the perceptions and knowledge that medicine and pharmacy residents have about each other\u27s professions
Conflicts of Interest Policy - Employees
No full textThis policy requires all employees to act solely in the best interests of the organization when making decisions and exercising their authority. To this aim, the policy establishes procedures for disclosing and managing a financial interest or other relationship that results in a potential conflict of interest involving any arrangement, decision, or transaction involving the University.
Applies to all employees in management, finance, research, or other designated positions. This policy supplements the ethical principles set forth in the University’s Ethical Code of Conduct policy and implements disclosure requirements established under this policy, the University’s Excess Benefit Transactions policy, and the Financial Conflicts of Interest in Research policy
COVID Vaccine Policy 2023 Update
No full textFor the safety of its employees and students, has adopted a policy regarding vaccination for COVID-19. From June 2022 through May 11, 2023, UHSP had a strict “fully vaccinated” requirement for all faculty, staff and students who did not have a valid medical or religious exemption. With the end of the COVID-19 public health emergency declaration, UHSP has shifted its stance to highly recommending the COVID-19 vaccine. Certain employees and students, such as faculty with clinical responsibilities and students rotating through sites requiring vaccination, such as in the Pharm.D. program, are still required to be fully vaccinated