Research Practices and Needs Among Spine Surgeons Worldwide

Objective Resource allocation to research activities is challenging and there is limited evidence to justify decisions. Members of AO Spine were surveyed to understand the research practices and needs of spine surgeons worldwide. Methods An 84-item survey was distributed to the AO Spine community in September of 2020. Respondent demographics and insights regarding research registries, training and education, mentorship, grants and financial support, and future directions were collected. Responses were anonymous and compared among regions. Results A total of 333 spine surgeons representing all geographic regions responded; 52.3% were affiliated with an academic/university hospital, 91.0% conducted clinical research, and 60.9% had 5+ years of research experience. There was heterogeneity among research practices and needs across regions. North American respondents had more research experience ( P = .023), began conducting research early on ( P < .001), had an undergraduate science degree ( P < .001), and were more likely to have access to a research coordinator or support staff ( P = .042) compared to other regions. While all regions expressed having the same challenges in conducting research, Latin America, and Middle East/Northern Africa respondents were less encouraged to do research ( P < .001). Despite regional differences, there was global support for research registries and research training and education. Conclusion To advance spine care worldwide, spine societies should establish guidelines, conduct studies on pain management, and support predictive analytic modeling. Tailoring local/regional programs according to regional needs is advised. These results can assist spine societies in developing long-term research strategies and provide justified rationale to governments and funding agencies.

48. Local Implementation of an Antibiotic Stewardship Intervention for Asymptomatic Bacteriuria Through Centralized Facilitation Required Minimal Costs and Effort

Background The cost of an antibiotic stewardship intervention is an important yet often neglected factor in antibiotic stewardship research. We studied the costs associated with successful implementation of the “Kicking CAUTI” intervention to decrease treatment of asymptomatic bacteriuria (ASB). Methods A central coordinating site facilitated roll-out of an audit and feedback intervention to decrease unnecessary urine cultures and antibiotic treatment in patients with ASB in four Veterans Affairs medical centers. Each site had a physician site champion, a part-time research coordinator, and 1-2 additional participants (often pharmacists). Participants kept weekly time-logs to collect the minutes associated with intervention tasks, and percent full-time effort (FTE) and costs were computed. For weeks with missing logs the average minutes for each activity associated with each type of professional was imputed. Salary information was obtained from the Bureau of Labor Statistics and Association of American Medical Colleges. Results Research coordinator time comprised of majority of the personnel time, followed by the physician site champions (Figure 1). Each intervention site required about 10% FTE/year of a research coordinator, and 3.5% FTE/year and 3.8% FTE/year of a physician and pharmacist respectively. The coordinating site required 37% FTE/year of a research coordinator, and 9% FTE of a physician to spearhead the intervention. Research coordinators predominantly spent their time on chart-reviews and project coordination. Physician champions predominantly spent their time on delivering audit and feedback and project coordination. The intervention cost USD 22,299/year per site on average, and USD 45,359/year for the coordinating site. Conclusion The Kicking CAUTI intervention was successful at reducing urine cultures and associated antibiotic use, with minimal time from the local team members. The research coordinators’ time was primarily spent on collection of research data, which will not be necessary outside of a research project. Our model of centralized facilitation makes economic sense for widespread scale-up and dissemination of antibiotic stewardship interventions in integrated healthcare systems. Disclosures Barbara Trautner, MD, PhD, Genentech (Consultant, Scientific Research Study Investigator)

An evaluation of factors that may influence clinicians’ decisions not to enroll eligible patients into randomized trials in critical care

Objectives To determine the association between intensive care unit (ICU) characteristics and clinicians’ decision to decline eligible patients for randomization into a multicentered pragmatic comparative-effectiveness controlled trial. Methods Screening logs from the Adjunctive Glucocorticoid Therapy in Septic Shock Trial (ADRENAL) and site-level data from the College of Intensive Care Medicine and Australia New Zealand Intensive Care Society were examined. The effects of ICU characteristics such as tertiary academic status, research coordinator availability, number of admissions, and ICU affiliations on clinicians declining to randomize eligible patients were calculated using mixed effects logistic regression modelling. Results There were 21,818 patients screened for inclusion in the ADRENAL trial at 69 sites across five countries, out of which 5,501 were eligible, 3,800 were randomized and 659 eligible patients were declined for randomization by the treating clinician. The proportion of eligible patients declined by clinicians at individual ICUs ranged from 0 to41%. In the multivariable model, none of the ICU characteristics were significantly associated with higher clinician decline rate. Conclusions Neither tertiary academic status, nor other site-level variables were significantly associated with increased rate of clinicians declining eligible patients.

The appearance and increase in the quantity and proportion of the clinical research coordinator’s service fee in drug clinical trial research fund and its impact on trial quality

Objective The changes of absolute value and relative value of clinical research coordinator service fee and its influence on the quality of drug clinical trial were analyzed. Methods This study compared the amount and structural changes of drug clinical trial costs in before 3 years and after 3 years of self-examination and inspection initiated by the China Food and Drug Administration, identified the increase number and composition of each individual cost of a clinical trial research funds which including clinical research coordinator service fee, investigator labor fee, subjects examination fee, subjects traffic subsidy, documents management fee, drug management fee, etc. Result The most significant appearance of increase in volume and proportion was the clinical research coordinator service fee. From the initial few to the global multicenter tumor drug clinical trials RMB31,624 or 34.92% of the proportion and domestic multicenter tumor drug clinical trials RMB16,500, accounted for 33.74%. Discussion It has become common for more money to be spent on clinical trials to be accompanied by improved quality, but the occurrence and continuous increase of clinical research coordinator service fee were divided into two aspects, On the one hand, the quality of clinical trials was promoted by the large amount of low-skill trivial work undertaken by clinical research coordinator; on the other hand, the quality of clinical trials was undermined by the fact that clinical research coordinator did too much treatment evaluation work that should have been done by the investigator. Conclusion The clinical research coordinators’ access standards, pre-employment training and examination, job and performance evaluation, in addition to the SMO specification management and avoiding malicious competition between the industry, are important factors in the quality assurance of drug clinical trials.

Feasibility, Acceptability, and Preliminary Effectiveness of a Compassion-Centered Team Intervention to Improve Clinical Research Coordinator Resilience and Well-Being

PURPOSE: Oncology clinical research coordinators (CRCs) and team-based coordinator care are critical for the success of clinical trials. However, CRCs typically report elevated anxiety and burnout and many oncology centers have high levels of coordinator attrition. To address the need for a team-based intervention to reduce burnout and promote resilience and cohesion among CRCs, we developed a compassion-centered, team-based intervention, Compassion-Centered Spiritual Health Team Intervention (CCSH-TI). METHODS: Participants were CRCs working in disease-specific teams within a comprehensive cancer center. CRCs were randomly assigned by team to either participate in four 60-minute sessions of CCSH-TI or receive the intervention after the study. To evaluate whether CCSH-TI is feasible and acceptable, we used a mixed-method approach including self-report questionnaires and a focus group. To evaluate the impact of CCSH-TI, we assessed self-reported resilience, well-being, burnout, and team civility before and immediately after the intervention period (ClinicalTrials.gov identifier: NCT04060901 ). RESULTS: Attendance varied by team, but all teams had rates more than 60%. Coordinators rated high levels of credibility of CCSH-TI to improve burnout, and the majority reported that they received benefits, particularly in resilience and stress management, indicating acceptability. Coordinators randomly assigned to CCSH-TI reported an increase in resilience compared with coordinators randomly assigned to the wait-list group (F(41) = 4.53, P = .039). CONCLUSION: Data from this pilot study indicate that CCSH-TI may be a feasible, credible, acceptable, and effective intervention to augment individual resilience among CRCs. However, the quantitative and qualitative data suggest that more comprehensive and systematic programming is necessary to truly mitigate burnout.

The Presence of Ghost Publications Among Canadian Plastic Surgery Residency Applicants: How Honest Are Canadians?

Background: Physicians with history of unprofessional behaviour during their medical training are shown to be 3 times more likely to have board disciplinary action later in their career. One realm in which unprofessional behaviour takes place is the phenomenon of unverifiable publications or “ghost publications.” To that end, this study aims to assess the rate of ghost publications among a recent cohort of Canadian Plastic Surgery residency applicants to determine if this phenomenon is geographic in nature. Methods: The current study was a retrospective, cross-sectional observational study; a review of all residency applications submitted to a single Canadian Plastic Surgery residency program from 2015 to 2018 was performed and all their listed publications were verified for accuracy. The review was conducted by a third party librarian and a research coordinator blinded to the authors identifying information. “Ghost publication” was defined as any publication listed as “published,” “accepted,” or “in-press” that did not exist in the literature. Results: A total of 196 applications of 186 applicants were submitted over the span of 4 years. A total of 362 publications listed as peer-reviewed articles, belonging to 114 applications were extracted and reviewed. Among the 362 publications listed as peer-reviewed articles, 2 could not be found in the literature (0.55%). Additionally, 42 citations were found with 48 minor differences than what was cited. Conclusions: The rate of ghost publications among recent applicants to a Plastic Surgery residency program is low (less than 1%). Future studies should investigate methods to further improve and instill the value of professionalism in our future plastic surgery trainees.

Clinical research and burnout syndrome in Italy – only a physicians’ affair?

Background The burnout phenomenon has been extensively investigated among health care professionals, particularly focusing on physicians and nurses. However, literature concerning burnout in clinical research is poor and often neglects the other professional categories involved. Methods In March 2019, all members of Italian Group of Clinical Research Coordinator were invited to participate to a web survey, consisting of three sections: general information and workload; Maslach Burnout Inventory (MBI) test; subjective perception of oneself’s work stress and possible causes. Results The majority of respondents felt a form of distress. The main source was contract type (31.2%), followed by workload (20.5%) and lack of skills recognition (17.8%). Results from MBI test confirmed the interviewees’ subjective perception: an intermediate level of emotional exhaustion (19.1 points) and a very high sense of reduced professional achievement (26.8 points) were observed. Both depersonalization and sense of reduced professional achievement showed weak to moderate correlations with emotional exhaustion. Emotional exhaustion was associated with contract type with high significance. Conclusion It is necessary to act on those qualitative factors that are greatly increasing the level of perceived stress, jeopardizing the quality of clinical research coordinators work and significantly amplifying the phenomenon of migration towards the private sector.