Leveraging Real-world Data to Increase Procedure Room Capacity: A Multidisciplinary Quality Improvement Project
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ABSTRACT:
SUBMITTER: Feldman R
PROVIDER: S-EPMC10997288 | biostudies-literature | 2022 Jan
REPOSITORIES: biostudies-literature
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Project description:PurposeTransCelerate BioPharma surveyed its member biopharmaceutical companies to understand current practices and identify opportunities to complement safety signal assessment with rapid real-world data (RWD) analysis.MethodsA voluntary 30-question questionnaire regarding the use of RWD in safety signal assessment was disseminated to subject matter experts at all TransCelerate member companies in July 2022. Responses were blinded, aggregated, summarized, and presented.ResultsEighteen of 20 member companies provided responses to the questionnaire. Sixteen (89%) companies reported actively leveraging RWD in their signal assessment processes. Of 18 respondent companies, 8 (44%) routinely use rapid approaches to RWD analysis, 7 (39%) utilize rapid RWD analysis non-routinely or in a pilot setting, 2 (11%) are considering using rapid RWD analysis, and 1 (6%) has no plans to use rapid RWD analysis for their signal assessment. Most companies reported that RWD adds context to and improves quality of signal assessments. To conduct RWD analysis for signal assessment, 16 of 17 (94%) respondent companies utilize or plan to utilize internally available data, 8 (47%) utilize both internal and external data, and 3 (18%) utilize data networks. Respondents identified key challenges to rapidly performing RWD analyses, including data access/availability, time for analysis execution, and uncertainties regarding acceptance of minimal or non-protocolized approaches by health authorities.ConclusionBiopharmaceutical companies reported that they see value in the use of rapid RWD analyses for complementing signal assessments. Future work is recommended to offer a framework and process for use of rapid use of RWD analyses in signal assessment.
| S-EPMC11530550 | biostudies-literature
Project description:BackgroundThe availability of high fidelity electronic health record (EHR) data is a hallmark of the learning health care system. Washington State's Surgical Care Outcomes and Assessment Program (SCOAP) is a network of hospitals participating in quality improvement (QI) registries wherein data are manually abstracted from EHRs. To create the Comparative Effectiveness Research and Translation Network (CERTAIN), we semi-automated SCOAP data abstraction using a centralized federated data model, created a central data repository (CDR), and assessed whether these data could be used as real world evidence for QI and research.ObjectivesDescribe the validation processes and complexities involved and lessons learned.MethodsInvestigators installed a commercial CDR to retrieve and store data from disparate EHRs. Manual and automated abstraction systems were conducted in parallel (10/2012-7/2013) and validated in three phases using the EHR as the gold standard: 1) ingestion, 2) standardization, and 3) concordance of automated versus manually abstracted cases. Information retrieval statistics were calculated.ResultsFour unaffiliated health systems provided data. Between 6 and 15 percent of data elements were abstracted: 51 to 86 percent from structured data; the remainder using natural language processing (NLP). In phase 1, data ingestion from 12 out of 20 feeds reached 95 percent accuracy. In phase 2, 55 percent of structured data elements performed with 96 to 100 percent accuracy; NLP with 89 to 91 percent accuracy. In phase 3, concordance ranged from 69 to 89 percent. Information retrieval statistics were consistently above 90 percent.ConclusionsSemi-automated data abstraction may be useful, although raw data collected as a byproduct of health care delivery is not immediately available for use as real world evidence. New approaches to gathering and analyzing extant data are required.
| S-EPMC5983060 | biostudies-literature
Project description: Not available
| S-EPMC9846327 | biostudies-literature
Project description:BackgroundPercutaneous injuries from needlesticks are a major occupational hazard for nurses.Local problemReducing subcutaneous insulin-related needlestick injuries was part of a nurse-led comprehensive sharps injury-reduction program at an integrated, not-for-profit health system.MethodsThe incident rate of needlestick injuries was compared between 1 year before and 1 year after introducing this quality improvement project.InterventionsA system-wide educational program instituting changes in subcutaneous insulin administration practices was combined with supply chain standardization using a single type of safety-engineered insulin syringe.ResultsThe average monthly incidence of needlestick injuries per 10 000 subcutaneous insulin injections fell significantly from year to year (incidence rate ratio, 0.49; 95% CI, 0.30-0.80; Poisson regression P = .004). One-year cost savings for supplies totaled $3500; additional annual median savings were $24 875 (2019 US dollars) in estimated costs of needlestick injuries averted.ConclusionsThe effectiveness of this multifaceted project provides a practical template to reduce subcutaneous insulin-related needlestick injuries.
| S-EPMC8608009 | biostudies-literature
Project description:IntroductionPatient portal enrollment following pediatric emergency department (ED) visits allows access to critical results, physician documentation, and telehealth follow-up options. Despite these advantages, there are many challenges to portal invitation and enrollment. Our primary objective was to improve patient portal enrollment rates for discharged pediatric ED patients.MethodsA multidisciplinary team of staff from two ED sites developed successful portal enrollment interventions through sequential Plan-Do-Study-Act cycles from October 2020 to October 2021. Interventions included a new invitation process, changes to patient paperwork on ED arrival, staff portal education, and changes to discharge paperwork and the portal website. The team utilized statistical process control charts to track the percentage of eligible discharged patients who received a portal invitation (process measure) and enrolled in the patient portal.ResultsBefore the study's initiation, less than 1% of eligible patients received patient portal invites or enrolled in the patient portal. Statistical process control charts revealed significant changes in enrollment and baseline shift at both a large academic ED campus and a satellite ED site by May 2021. Improvements in invitation rates were also observed at both campuses. Changes were sustained for over 6 months at both locations.ConclusionsHigh-reliability interventions and a multidisciplinary approach allowed for significant and sustained improvement in patient portal invitation and enrollment rates in eligible pediatric ED patients. Future study will examine enrollment patterns across patient demographics and further high-reliability interventions.
| S-EPMC10990375 | biostudies-literature
Project description:BackgroundPatient-to-physician continuity is the result of coordinated and consistent care. Optimizing continuity can be a challenge in medical training without impacting work hours. We sought to use quality improvement science during graduate medical training to increase outpatient continuity.ObjectiveThe primary goal was to improve outpatient continuity in our pediatric cardiology fellowship, without increasing trainee clinic hours, from a baseline of 38% to ≥70% within 18 months.MethodsOur fellowship conducted a quality improvement project across 3 years to improve continuity-of-care in our outpatient clinic using the Institute for Healthcare Improvement model for improvement. We conducted Plan-Do-Study-Act cycles and completed a key driver diagram using a multidisciplinary team. We defined continuity as a patient being evaluated by their primary fellow or a different fellow that was provided a handoff. The outcome measure was the continuity rate over 2-week periods.ResultsContinuity improved from 38% to ≥80%. The improvement resulted from a series of interventions, including creating a handoff system among fellows, identifying follow-up patients in advance, and communicating this information to the clinic team. Although we anticipated a decrease when new fellows were incorporated, continuity continued to be ≥70%. This system retained continuity above 90% one year after completion of the project.ConclusionsOur fellowship created a system change to improve primary patient-to-fellow continuity care rates. We achieved sustainable continuity by working with a multidisciplinary team without altering staffing, infrastructure, or fellow work hours. This project engaged trainees to address the practical application of quality improvement methodology to solve a common clinical problem.
| S-EPMC7297393 | biostudies-literature
Project description:The present study aimed to investigate temporal trends in treatment patterns and prognostic factors for overall survival (OS) among patients with metastatic pancreatic cancer. From the Tokushukai REAl-world Data project, 1,093 patients with metastatic pancreatic cancer treated with gemcitabine, tegafur/gimeracil/oteracil (S-1), gemcitabine plus S-1, gemcitabine plus nab-paclitaxel, or fluorouracil, folic acid, oxaliplatin and irinotecan (FOLFIRINOX) between April 2010 and March 2020 were identified. Stratified/conventional Cox regression analyses were conducted to examine associations between patient- and tumor-related factors, study period, hospital volume, hospital type and first-line chemotherapy regimens. Overall, 846 patients were selected (503 male patients; median age, 70 years) after excluding ineligible patients. Over a median follow-up of 5.4 months, the median OS was 6.8 months (95% confidence interval, 6.3-7.4). The median OS for gemcitabine, S-1, gemcitabine plus S-1, gemcitabine plus nab-paclitaxel and FOLFIRINOX regimens was 5.9, 5.3, 7.7, 9.0 and 9.5 months, respectively. The median OS for 2010-2013, 2014-2017 and 2017-2020 was 6.2, 7.1 and 7.8 months, respectively. Performance status, body mass index and first-line chemotherapy regimens were identified to be significant prognostic factors. In summary, the real-world data indicated that standard care, including chemotherapy, for metastatic pancreatic cancer was widely used in hospitals throughout Japan and verified the survival benefits of gemcitabine plus nab-paclitaxel and FOLFIRINOX observed in prior clinical trials. This trial has been registered in the University Hospital Medical Information Network Clinical Trials Registry as UMIN000050590 on April 1, 2023.
| S-EPMC10636700 | biostudies-literature
Project description:BackgroundPreventing respiratory infectious disease exposures is a performance improvement project to reduce the incidence of occupational health exposures among health care workers. This project encouraged registered nurses to quickly identify and isolate potentially infectious patients in the emergency room, to prevent exposures to airborne and droplet transmitted communicable diseases, including meningitis, tuberculosis, and measles.MethodsThis pre- and postintervention model implemented a quasi-experimental designed project in the emergency room (ER). The Centers for Disease Control's empiric transmission-based isolation precautions were implemented to prevent occupational health exposures. Eighty registered nurses (RN's) received education on the new intervention. The assumption of this project was, the new process will decrease occupational health exposures.ResultsEight ER RNs reported an occupational health exposure, preintervention in quarter 2 of 2019, compared to zero occupational health exposures, postintervention in quarter 3 of 2019. A χ² independence test was used to determine if the categorical variables of the capstone intervention and disease exposure were related in the same RN population. An association between the capstone intervention and disease exposure was observed, X2 (1) = 8.421, P = .004, indicating the result is statistically significant.ConclusionsThe preventing respiratory infectious disease exposures project effectively reduced occupational health exposures to airborne and droplet transmitted diseases in the emergency room by 100%. These results should encourage Infection Preventionists to adapt the Centers for Disease Control's empiric transmission isolation precautions in their emergency rooms and urgent cares to prevent airborne and droplet transmitted disease exposures.
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Project description:Randomized controlled clinical trials and real-world observational studies provide complementary information but with different validity. Some clinical questions (disease behavior, prognosis, validation of outcome measures, comparative effectiveness, and long-term safety of therapies) are often better addressed using real-world data reflecting larger, more representative populations. Integration of disease history, clinician-reported outcomes, performance tests, and patient-reported outcome measures during patient encounters; imaging and biospecimen analyses; and data from wearable devices increase dataset utility. However, observational studies utilizing these data are susceptible to many potential sources of bias, creating barriers to acceptance by regulatory agencies and the medical community. Therefore, data standardization and validation within datasets, harmonization across datasets, and application of appropriate analysis methods are important considerations. We review approaches to improve the scope, quality, and analyses of real-world data to advance understanding of multiple sclerosis and its treatment, as an example of opportunities to better support patient care and research.
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Project description:The paradigm type I interferonopathy Aicardi-Goutières syndrome (AGS) is most typically characterized by severe neurological involvement. AGS is considered an immune-mediated disease, poorly responsive to conventional immunosuppression. Premised on a chronic enhancement of type I interferon signaling, JAK1/2 inhibition has been trialed in AGS, with clear improvements in cutaneous and systemic disease manifestations. Contrastingly, treatment efficacy at the level of the neurological system has been less conclusive. Here, we report our real-word approach study of JAK1/2 inhibition in 11 patients with AGS, providing extensive assessments of clinical and radiological status; interferon signaling, including in cerebrospinal fluid (CSF); and drug concentrations in blood and CSF. Over a median follow-up of 17 months, we observed a clear benefit of JAK1/2 inhibition on certain systemic features of AGS, and reproduced results reported using the AGS neurologic severity scale. In contrast, there was no change in other scales assessing neurological status; using the caregiver scale, only patient comfort, but no other domain of everyday-life care, was improved. Serious bacterial infections occurred in 4 out of the 11 patients. Overall, our data lead us to conclude that other approaches to treatment are urgently required for the neurologic features of AGS. We suggest that earlier diagnosis and adequate central nervous system penetration likely remain the major factors determining the efficacy of therapy in preventing irreversible brain damage, implying the importance of early and rapid genetic testing and the consideration of intrathecal drug delivery.
| S-EPMC10175907 | biostudies-literature