Lessons Learned Establishing the Palliative Care Research Cooperative's Qualitative Data Repository.

Data sharing is increasingly an expectation in health research as part of a general move toward more open sciences. In the United States, in particular, the implementation of the 2023 National Institutes of Health Data Management and Sharing Policy has made it clear that qualitative studies are not exempt from this data sharing requirement. Recognizing this trend, the Palliative Care Research Cooperative Group (PCRC) realized the value of creating a de-identified qualitative data repository to complement its existing de-identified quantitative data repository. The PCRC Data Informatics and Statistics Core leadership partnered with the Qualitative Data Repository (QDR) to establish the first serious illness and palliative care qualitative data repository in the U.S. We describe the processes used to develop this repository, called the PCRC-QDR, as well as our outreach and education among the palliative care researcher community, which led to the first ten projects to share the data in the new repository. Specifically, we discuss how we co-designed the PCRC-QDR and created tailored guidelines for depositing and sharing qualitative data depending on the original research context, establishing uniform expectations for key components of relevant documentation, and the use of suitable access controls for sensitive data. We also describe how PCRC was able to leverage its existing community to recruit and guide early depositors and outline lessons learned in evaluating the experience. This work advances the establishment of best practices in qualitative data sharing.

Impact of COVID-19 on patients undergoing scheduled procedures for chronic venous disease.

OBJECTIVE: The COVID-19 pandemic has drastically altered the medical landscape. Various strategies have been employed to preserve hospital beds, personal protective equipment, and other resources to accommodate the surges of COVID-19 positive patients, hospital overcapacities, and staffing shortages. This has had a dramatic effect on vascular surgical practice. The objective of this study is to analyze the impact of the COVID-19 pandemic on surgical delays and adverse outcomes for patients with chronic venous disease scheduled to undergo elective operations. METHODS: The Vascular Surgery COVID-19 Collaborative (VASCC) was founded in March 2020 to evaluate the outcomes of patients with vascular disease whose operations were delayed. Modules were developed by vascular surgeon working groups and tested before implementation. A data analysis of outcomes of patients with chronic venous disease whose surgeries were postponed during the COVID-19 pandemic from March 2020 through February 2021 was performed for this study. RESULTS: A total of 150 patients from 12 institutions in the United States were included in the study. Indications for venous intervention were: 85.3% varicose veins, 10.7% varicose veins with venous ulceration, and 4.0% lipodermatosclerosis. One hundred two surgeries had successfully been completed at the time of data entry. The average length of the delay was 91 days, with a median of 78 days. Delays for venous ulceration procedures ranged from 38 to 208 days. No patients required an emergent intervention due to their venous disease, and no patients experienced major adverse events following their delayed surgeries. CONCLUSIONS: Interventions may be safely delayed for patients with venous disease requiring elective surgical intervention during the COVID-19 pandemic. This finding supports the American College of Surgeons' recommendations for the management of elective vascular surgical procedures. Office-based labs may be safe locations for continued treatment when resources are limited. Although the interventions can be safely postponed, the negative impact on quality of life warrants further investigation.

Primary Author Characteristics Associated With Publication in the Journal of Pain and Symptom Management.

CONTEXT: Scientific journals are the primary source for dissemination of research findings, and this process relies on rigorous editorial and peer-review. As part of continuing efforts by the Journal of Pain and Symptom Management (JPSM) to advance equity, diversity, and inclusion, JPSM's leadership requested an external evaluation of their publication decisions. OBJECTIVES: 1) Describe primary author characteristics associated with final decisions to accept or reject manuscripts submitted for publication; 2) Report on whether there are potential publication biases in the JPSM editorial or peer-review processes. METHODS: Data consisted of self-reported primary author demographic characteristics associated with manuscript submissions between June 18, 2020, and December 31, 2022. Characteristics included region of residence, race, gender, and ethnicity. A multiple logistic regression model was used to estimate adjusted odds of rejection for each author characteristic. RESULTS: A total of 1940 submissions were evaluated. Compared to authors residing in North America, authors residing in Asia had six-fold greater odds of rejection, authors residing in Europe had four-fold greater odds of rejection, and authors residing in other regions had two-fold greater odds of rejection. Female authors submitted 1.7 times more papers than males, but there was no difference in acceptance rates of their papers in adjusted analysis. CONCLUSION: In this analysis of publication decisions by the JPSM, there were differences in acceptance rates by region of residence, ethnicity, and race but not by gender. Asian authors and authors residing in regions outside of North America had greater odds of rejection compared to White or North American authors.

Carotid Artery Operation Delay During the Covid-19 Pandemic: Results of a Multicenter International Study.

BACKGROUND: To measure the impact of the COVID-19 pandemic on the management of patients with carotid artery stenosis. METHODS: We prospectively collected data from 25 centers (19 centers in the United States and 6 centers internationally) on postponed carotid artery operations between March 2020 and January 2022. We describe the characteristics of these patients and their planned operations, along with outcomes including mortality and neurological deterioration during the period of operative delay due to the COVID-19 pandemic. RESULTS: A total of 1,220 vascular operations were postponed during the pandemic, of them 96 patients presented with significant carotid stenosis (median stenosis of 71%; interquartile range; 70-80) and 80% of them were planned for carotid endarterectomy. Most patients were asymptomatic (69%), and 31% of patients were symptomatic (16% of patients had a stroke, 15% of patients had a transient ischemic attack, and 1% of patients experienced amaurosis fugax). The median length of surgical delay was 71 days (interquartile range: 45.5, 115.5). At the data entry time, 62% of patients had their carotid operations postponed and successfully completed. Most postponements (72%) were due to institutional policies aimed at resource conservation. During the delay, no patient decompensated or required an urgent operation. A total of 5 patients (5%) with carotid stenosis died while awaiting operations due to COVID-19. CONCLUSIONS: Our study of a cohort of patients with carotid artery stenosis who underwent a median delay of 71 days during the COVID-19 pandemic showed a disparate operation delay between US regions and internationally, most postponements were due to hospital policy, and none of the patients deteriorated or required an emergency surgery during the delay.

The association between obesity and postoperative outcomes in a broad surgical population: A 7-year American College of Surgeons National Surgical Quality Improvement analysis.

BACKGROUND: The number of obese surgical patients continues to grow, and yet obesity's association with surgical outcomes is not totally clear. This study examined the association between obesity and surgical outcomes across a broad surgical population using a very large sample size. METHODS: This was an analysis of the 2012 to 2018 American College of Surgeons National Surgical Quality Improvement database, including all patients from 9 surgical specialties (general, gynecology, neurosurgery, orthopedics, otolaryngology, plastics, thoracic, urology, and vascular). Preoperative characteristics and postoperative outcomes were compared by body mass index class (normal weight 18.5-24.9 kg/m2, overweight 25.0-29.9, obese class I 30.0-34.9, obese II 35.0-39.9, obese III ≥40). Adjusted odds ratios were computed for adverse outcomes by body mass index class. RESULTS: A total of 5,572,019 patients were included; 44.6% were obese. Median operative times were marginally higher for obese patients (89 vs 83 minutes, P < .001). Compared to normal weight patients, overweight and obese patients in classes I, II, and III all had higher adjusted odds of developing infection, venous thromboembolism, and renal complications, but they did not exhibit elevated odds of other postoperative complications (mortality, overall morbidity, pulmonary, urinary tract infection, cardiac, bleeding, stroke, unplanned readmission, or discharge not home (except for class III patients). CONCLUSION: Obesity was associated with increased odds of postoperative infection, venous thromboembolism, and renal but not the other American College of Surgeons National Surgical Quality Improvement complications. Obese patients need to be carefully managed for these complications.

A primer on cohort studies in vascular surgery research.

Vascular research questions can be answered using various study designs. Observational studies are used frequently to address a wide range of clinical questions when randomized clinical trials are not feasible or practical. One of the powerful vascular research tools is the cohort study. The cohort study is a reliable observational study design in which individuals who share a common characteristic (a cohort) are followed over time and their outcomes are assessed at various intervals. This review focuses on the essential characteristics, design, implementation, bias, validity, and clinical significance of cohort studies and provides illustrative examples. A cohort study can be either a prospective or a retrospective study, depending on whether the outcome occurred before or after the enrollment of the cohort. Each type has its advantages and disadvantages. Confounding, selection, and information biases can all occur in cohort studies. Applications of the cohort study design include studying the natural history of a disease, describing a condition's frequency, and investigating multiple outcomes simultaneously.