Since the publication of Standards for QUality Improvement Reporting Excellence (SQUIRE 1.0) guidelines in 2008, the science of the field has advanced considerably. In this manuscript, we describe ...the development of SQUIRE 2.0 and its key components. We undertook the revision between 2012 and 2015 using (1) semistructured interviews and focus groups to evaluate SQUIRE 1.0 plus feedback from an international steering group, (2) two face-to-face consensus meetings to develop interim drafts and (3) pilot testing with authors and a public comment period. SQUIRE 2.0 emphasises the reporting of three key components of systematic efforts to improve the quality, value and safety of healthcare: the use of formal and informal theory in planning, implementing and evaluating improvement work; the context in which the work is done and the study of the intervention(s). SQUIRE 2.0 is intended for reporting the range of methods used to improve healthcare, recognising that they can be complex and multidimensional. It provides common ground to share these discoveries in the scholarly literature (http://www.squire-statement.org).
We conducted a quality improvement project from 2019 to 2021 at a single home health agency to reduce rates of central line-associated bloodstream infection in our ambulatory pediatric population. ...Annualized central line-associated bloodstream infection rates per 1,000 catheter line days decreased by 20 % during the study period, from a rate of 1.023 to 0.810. This decrease was sustained in the 10-month post-study period with a center line shift of 1.090 to 0.658.
•Assessment of caregivers’ perceptions and practices is key to CLABSI prevention.•Visual checklists and standardized instructions can improve adherence to CL care.•Collaboration between home health agencies and hospital stakeholders is achievable.
Abstract
INTRODUCTION
Intraventricular chemotherapy administered through an Ommaya reservoir (OR) constitutes the mainstay of therapy for adults with leptomeningeal metastases from solid and ...hematologic malignancies. Unfortunately, OR-associated bacterial meningitis remains a relatively frequent, costly, often morbid, and occasionally fatal complication, limiting the benefit of this approach. We investigated the potential efficacy, cost savings, and toxicity of intraventricular vancomycin co-administered with intraventricular chemotherapy.
METHODS
Detailed demographic, treatment, and outcome data were collected prospectively between 5/1/21 and 4/30/22 for 63 consecutive patients at our institution who underwent OR placement and subsequent intraventricular chemotherapy, co-administered with 10 mg of intraventricular vancomycin at each treatment. Reservoir-associated bacterial meningitis was defined as 2 consecutive positive cultures from the cerebrospinal fluid of the same organism or 1 positive culture in the presence of any other clinical or laboratory evidence of infection, or signs of infection at the surgical site.
RESULTS
The infection rate was 0% 95% CI 0-6.75% among the 63 patients and 0% 0-0.76% in the 501 consecutive treatments administered over the 12-month study period compared to 10.25% 7.39- 14.0% in 322 patients and 1.71% 1.22-2.39% in 1932 treatments over the preceding 5 years. The absolute risk reduction was 10.3% 3.83 - 14.04, p = 0.0049. The number needed to treat was 10 7-26. Cost per vancomycin dose was $10.00 ($5,010 over 12 months). The cost of non-surgical treatment of one OR-associated infection is $88,337.70, which translates into a $618,363.90 savings for the estimated 7 patients over 12 months spared an OR-associated infection. Savings were even further increased if OR removal and subsequent replacement was required. The only other covariate associated with (increased) infection risk on multivariable analysis was treatment number. No treatment-associated toxicity was observed.
CONCLUSION
Prophylactic intraventricular vancomycin eliminated OR-associated infection in patients receiving intraventricular chemotherapy. Dramatic cost savings were achieved without added toxicity.
Abstract
Post-operative venous sinus thrombosis (POVST) is an uncommon complication from a craniotomy for brain tumor resection. There are few data in how to treat POVST, including the use of ...anticoagulation and follow-up. It has been found that POVST is more common in dural-based lesions especially located on or near a sinus, however treatment has not been standardized. We retrospectively reviewed our POVST cases between January 2018 to December 2020 for brain tumor resection, whether we chose to start anticoagulation or not, and the eventual outcome. We also performed a literature review on the topic to compare findings and management. We identified 14 cases of POVST; 8 of the cases were for extra-axial masses. Of the 14, 6 POVST had clot involving the superior sagittal sinus (SSS), with 3 being discharged with a direct oral anticoagulant (DOAC) and one being discharged on warfarin. With transverse sinus involvement, 6 cases were noted (with no SSS clot), with 2 started on a DOAC and 2 being started on ASA 81mg. In the sigmoid sinus there were 2 cases and did not receive anticoagulation. Of the 14 total cases, 1 was symptomatic (new-onset seizures) necessitating surgical recanalization and no other cases had symptoms attributed to the POVST. Two patients died from unrelated reasons prior to receiving any outpatient imaging, and all other patients had recanalization of their involved sinuses within 2-5 months. There were no complications in patients receiving anticoagulation. Our literature review didn't show a standardized method in POVST treatment. There is also disagreement in what anticoagulation should be used, and if it is necessary. Based on our retrospective analysis and literature review, if the clot is symptomatic, involves the SSS, or propagates, we recommend anticoagulation. Outside the SSS, it should be determined on a case-by-case basis, but anticoagulation may not be necessary.
Abstract
BACKGROUND
Acute chemotherapy-induced peripheral neuropathy (CIPN) is a common and serious consequence of cancer treatment. However, for up to 30% of patients, CIPN persists beyond six ...months of completing chemotherapy, and is transformed to chronic (c)CIPN. Scrambler therapy (ST) is a therapeutic modality with emerging evidence supporting its ability to diminish CIPN symptoms, however, low reimbursement limits patient access to this potentially curative therapy.
METHODS
Data was from a convenience sample of 24 CIPN patients (with symptoms between 1-240 months after platinum-based, taxane, or combination chemotherapy) completing 10 sessions of ST using the Calmare® device in the City of Hope Outpatient Physical Therapy Department. Patients were treated for ~45 minutes per session over 10 sessions. Patients received a standardized assessment pre- and post ST that included: EORTC chemotherapy-induced peripheral neuropathy questionnaire (QLQ-CIPN20), mono-filament testing, pain intensity numerical rating scale, numbness scale, extensor hallicus longus strength, Timed Up and Go, Romberg, and single leg balance.
RESULTS
Significant changes were seen in post-treatment assessment of quality of life as measured by the QLQ-CIPN-20 and numbness scale. Post-treatment QLQ-CIPN-20 total scores decreased by an average of 7.1 points (n= 24, p< .01). Numbness in the left lower extremity decreased by an average of 1 point of the 0-4 point scale (n=24, p=.0007) and 1.09 points on the right lower extremity (n=24, p < .0004). There was a trend towards improvements in pain, monofilament testing, single leg balance, and Romberg test. Reimbursement for ST did not cover the costs to administer the therapy.
CONCLUSION
For patients with CIPN, scrambler therapy improves numbness and improves quality of life measures. However, reimbursement for ST did not cover the costs. Ways to improve this disparity are discussed.
Abstract
PROBLEM
Data quality impacts the validity of results obtained through clinical research due to several reasons. These include degradation of tumor tissue and other biological samples while ...being transported across large distances. Other concerns related to data collection include breach in patient privacy and loss and corruption of data. Such issues lead to generation of results that are either unreliable or unsuitable for analysis. Blockchain based digital solutions for clinical trials may be an answer to the problem.
SOLUTION
In this abstract we review one such software ‘Elsy’ that we have used to collect around 1000 samples from more than 70 centres nationwide. Elsy had been deployed on the smartphone and desktop and used by clinical trial teams to plan, execute and monitor the trial across multiple geographical locations. Collection of tumor specimens was monitored from the time the specimens left the operating room by leveraging blockchain technologies. Patient data was imported into the system seamlessly by integration with hospital electronic medical records systems. Customised data forms were mapped to automatically import data fields that were relevant. Once recruited, all patient sensitive data was immediately obfuscated, and a bar code was assigned to the patient, which served as the unique patient identifier. Data was encrypted in transit and at rest on a cloud server, with access requiring 2-factor authentication. Data viewing and editing permissions were tailored to meet patient privacy and security requirements. Changes in data were logged and monitored, eliminating wilful or accidental manipulation of data. AI and ML tools were integrated with the system to perform advanced analysis.
CONCLUSION
Digital platforms may have the potential to revolutionise the clinical trials systems by enabling the collection of clean and secure data.
Abstract
INTRODUCTION
Cranial neurosurgery confers psychological stress, as well as the stress of being in the hospital rather than in one’s preferred surroundings. Compared with inpatient ...admissions, same-day discharges reduce patient exposure to nosocomial infection, thromboembolic complications, and medical error. Also, it reduces costs to the health care system.
OBJECTIVE
To report the results of a pilot study that prospectively evaluated for the first time in a United States hospital, the outcomes of patients that underwent brain tumor surgery and are discharged home the same day as surgery.
METHODS
A quality intervention study including patients who underwent outpatient craniotomy for brain tumors by a single neurosurgeon (R.J.K) at the University of Miami from August 2020 to August 2021 was performed. Patients included were between 16 to 85 years old, with a Karnofsky Performance Status score of ≥ 70, and with supratentorial tumors with a maximum diameter of 4 cm. Complete demographic and clinical data were collected prospectively for each patient. In all patients, the minimum observation period was 6 h after surgery.
RESULTS
37 of 334 patients met the inclusion criteria for the outpatient protocol. Thirty-two patients were discharged on the same day as surgery. Five patients (14%) were considered eligible for outpatient surgery but were ultimately admitted to the hospital postoperatively and were discharged after overnight observation. No postoperative complications were noted at two-week follow-up.
CONCLUSION
With appropriate selection and postoperative monitoring, same-day discharge can be considered a safe and feasible option for certain craniotomy cases. Establishing a multidisciplinary team of physicians, nurses, radiologists, and physical therapists is critical to achieving this aim. Physicians should have a low threshold to admit a patient with concerning exam findings, complications, or complicated past medical history
Abstract
INTRODUCTION
Brain tumour intraoperative diagnosis (smear cytology, frozen section) is a commonly performed, routine diagnostic service. Currently, samples must be transported from the ...operating room (OR) to pathology, impacting turnaround time (TAT), carbon emissions (if cross-site), and motivation for repeat sampling. We performed a broad evaluation of current practice in a large, tertiary, UK brain tumour centre, to identify potential gains in real-time tissue diagnosis.
METHODS
All brain tumour samples (n=228) sent for intraoperative diagnosis in 2021 were analysed retrospectively. TAT was assessed by capturing different timepoints along the pathway. Concordance between diagnoses at the following stages was determined: preoperatively based on radiology, intraoperatively (frozen section or smear), provisional paraffin and final integrated. Additionally, we anonymously surveyed neurosurgeons’ opinions (n=18) on the current service.
RESULTS
The mean (±SD) specimen transportation time was 10.6±2.0 minutes, with an estimated total TAT of 30-60 minutes. Intraoperative diagnosis provided a slightly higher rate of concordance with provisional paraffin diagnosis than preoperative radiological diagnosis (89.5% vs 86.3%). Non-concordance was most commonly due to non-representative sampling (e.g., predominantly necrotic), with no repeat sample being sent/available intraoperatively. Prevailing neurosurgical opinion of the intraoperative diagnostic service was dissatisfaction or neutrality (50% and 39% of respondents), with a minority being positive (11%). Reasons for this included: intraoperative delay due to TAT (47%), perceived inaccuracy of results (41%), and perceived reduced out-of-hours availability (56%).
CONCLUSIONS
Current brain tumour intraoperative diagnostic practice relies on physical sample transportation and manual processing; the resultant long TAT causes surgeon dissatisfaction and dissuades repeat analysis in the case of non-representative sampling. Real-time tissue diagnostic technologies such as OR-sited probe-based confocal endomicroscopy, scanners and Raman spectroscopy should be considered to facilitate faster and repeated examination. The latter may have additional benefits in real-time expert pathology feedback, tumour margin-zone analysis and increased extent of resection.
Abstract
INTRODUCTION
ClinicalPath is an evidence-based oncology decision support and analytics tool for cancer care. ClinicalPath’s treatment recommendations are prioritized based on efficacy, ...toxicity, and cost by a nationwide committee of oncologists. The pathways are updated quarterly and are expected to speed the integration of new treatments into practice, standardize therapy, improve quality, and decrease cost. The pathway system also allows for local clinical trial mapping to promote clinical trial awareness and increase enrollment. ClinicalPath provides clinical pathways delivering personalized, evidence-based oncology guidance at the point of care. ClinicalPath’s network in North America serves more than 2,000 cancer physicians, within 54 practices in 31 states (15 academic medical centers, 29 hospital systems, and 9 community practices). Population: Our population is derived from multiple hospitals in Southern California within the Providence Health System. Methodology: Medical oncologists and Advanced Practice Providers received training on ClinicalPath before go-live. ClinicalPath was integrated into the Epic EHR in multiple Southern CA hospitals in a single month.
RESULTS
After 3 months of utilization within our Southern California region, 342 treatment decisions were made across all cancers, and 85.1% of cancer patients were treated on pathway. Of which, 7 treatment decisions were made within the neuro-oncology specialty, and 85.7% of those cancer patients were treated on pathway.
CONCLUSION
We successfully integrated and initiated ClinicalPath in a multiple hospital-affiliated community oncology clinical trial network. We are actively working across our Southern California Region to map locally available clinical trials to promote awareness and increase enrollment. Provider utilization and patient on-pathway rates are actively monitored and will be updated.
Abstract
The COVID-19 pandemic forced a redesign of clinical research to adapt to an ever-changing situation while minimizing patient and provider risks and preserving scientific discovery. During ...the initial surge of COVID-19, elective healthcare services and non-critical research operations were halted. These changes inspired dispersed health care operations and streamlined clinical research. The first wave of COVID-19 hit Detroit, Michigan, in March 2020, consuming Henry Ford Health (HFH), in COVID-19 emergency care. HFH has a clinically integrated liquid biopsy (LB) program where enrolled patients provide an LB sample via venipuncture within 7 days of each MRI, typically in the clinic at the point-of-care. Prior to COVID-19, 183 neuro-oncology patients were actively providing LB samples in clinic with a mean of 29.9 specimens monthly. Institutional COVID-19 restrictions on non-critical interactions resulted in months were nearly all outpatient encounters utilized telemedicine and decentralized testing off-site from research operations. This halted LB procurement to 4.55 specimens monthly during early pandemic months. To reduce patient-provider exposure, LB specimens were then procured with the venipuncture for MRI which streamlined LB operations and improved the patient experience. After this change, LB specimen procurement returned to near pre-pandemic levels with a mean of 28.1 monthly specimens, despite a significant population utilizing video visits and imaging at satellite or non-HFH centers. The pandemic forced adaptations to patient encounters that have changed how healthcare is delivered, resulting in parallel changes in research that must be considered in the design of future studies.
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