32 research outputs found

    SELECTIVE ASYMMETRIC CAPITAL FINANCING BEHAVIOR: PREFERENCE TOWARDS EQUITY FINANCING

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    Using data from 1,217 publicly traded Chinese companies from 1994–2006, we show that the capital financing behavior of Chinese firms deviates substantially from the pecking order theory in that equity issues are always the preferred financing source for funding requirements. We further document the existence of a stylized asymmetric financing pattern — equity issues are used much more heavily over debt issues under the condition of a fund flow surplus versus a fund flow deficit, which is the result of Chinese firms selecting the degree of inherent equity-issue preference feasible to pursue given their fund flow condition

    Scoping Meta-Review of Methods Used to Assess Artificial Intelligence-Based Medical Devices for Heart Failure

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    Artificial intelligence and machine learning (AI/ML) are playing increasingly important roles, permeating the field of medical devices (MDs). This rapid progress has not yet been matched by the Health Technology Assessment (HTA) process, which still needs to define a common methodology for assessing AI/ML-based MDs. To collect existing evidence from the literature about the methods used to assess AI-based MDs, with a specific focus on those used for the management of heart failure (HF), the International Federation of Medical and Biological Engineering (IFMBE) conducted a scoping meta-review. This manuscript presents the results of this search, which covered the period from January 1974 to October 2022. After careful independent screening, 21 reviews, mainly conducted in North America and Europe, were retained and included. Among the findings were that deep learning is the most commonly utilised method and that electronic health records and registries are among the most prevalent sources of data for AI/ML algorithms. Out of the 21 included reviews, 19 focused on risk prediction and/or the early diagnosis of HF. Furthermore, 10 reviews provided evidence of the impact on the incidence/progression of HF, and 13 on the length of stay. From an HTA perspective, the main areas requiring improvement are the quality assessment of studies on AI/ML (included in 11 out of 21 reviews) and their data sources, as well as the definition of the criteria used to assess the selection of the most appropriate AI/ML algorithm. © 2023 by the authors

    Development of a Reliable Surgical Quality Assurance System for 2-stage Esophagectomy in Randomized Controlled Trials

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    Objective: The aim was to develop a reliable surgical quality assurance system for 2-stage esophagectomy. This development was conducted during the pilot phase of the multicenter ROMIO trial, collaborating with international experts. Summary of Background Data: There is evidence that the quality of surgical performance in randomized controlled trials influences clinical outcomes, quality of lymphadenectomy and loco-regional recurrence. Methods: Standardization of 2-stage esophagectomy was based on structured observations, semi-structured interviews, hierarchical task analysis, and a Delphi consensus process. This standardization provided the structure for the operation manual and video and photographic assessment tools. Reliability was examined using generalizability theory. Results: Hierarchical task analysis for 2-stage esophagectomy comprised fifty-four steps. Consensus (75%) agreement was reached on thirty-nine steps, whereas fifteen steps had a majority decision. An operation manual and record were created. A thirty five-item video assessment tool was developed that assessed the process (safety and efficiency) and quality of the end product (anatomy exposed and lymphadenectomy performed) of the operation. The quality of the end product section was used as a twenty seven-item photographic assessment tool. Thirty-one videos and fifty-three photographic series were submitted from the ROMIO pilot phase for assessment. The overall Gcoefficient for the video assessment tool was 0.744, and for the photographic assessment tool was 0.700. Conclusions: A reliable surgical quality assurance system for 2-stage esophagectomy has been developed for surgical oncology randomized controlled trials

    Quality metrics for the evaluation of Rapid Response Systems: Proceedings from the third international consensus conference on Rapid Response Systems.

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    BACKGROUND: Clinically significant deterioration of patients admitted to general wards is a recognized complication of hospital care. Rapid Response Systems (RRS) aim to reduce the number of avoidable adverse events. The authors aimed to develop a core quality metric for the evaluation of RRS. METHODS: We conducted an international consensus process. Participants included patients, carers, clinicians, research scientists, and members of the International Society for Rapid Response Systems with representatives from Europe, Australia, Africa, Asia and the US. Scoping reviews of the literature identified potential metrics. We used a modified Delphi methodology to arrive at a list of candidate indicators that were reviewed for feasibility and applicability across a broad range of healthcare systems including low and middle-income countries. The writing group refined recommendations and further characterized measurement tools. RESULTS: Consensus emerged that core outcomes for reporting for quality improvement should include ten metrics related to structure, process and outcome for RRS with outcomes following the domains of the quadruple aim. The conference recommended that hospitals should collect data on cardiac arrests and their potential predictability, timeliness of escalation, critical care interventions and presence of written treatment goals for patients remaining on general wards. Unit level reporting should include the presence of patient activated rapid response and metrics of organizational culture. We suggest two exploratory cost metrics to underpin urgently needed research in this area. CONCLUSION: A consensus process was used to develop ten metrics for better understanding the course and care of deteriorating ward patients. Others are proposed for further development

    Laparoscopic Colorectal Surgery Outcomes Improved After National Training Program (LAPCO) for Specialists in England

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    OBJECTIVE: To examine the impact of The National Training Programme for Laparoscopic Colorectal Surgery (Lapco) on the rate of laparoscopic surgery and clinical outcomes of cases performed by Lapco surgeons after completion of training.SUMMERY BACKGROUND DATA: Lapco provided competency-based supervised clinical training for specialist colorectal surgeons in England.METHODS: We compared the rate of laparoscopic surgery, mortality and morbidity for colorectal cancer resections by Lapco delegates and non-Lapco surgeons in 3-year periods preceding and following Lapco using difference in differences analysis. The changes in the rate of post-Lapco laparoscopic surgery with the Lapco sign-off competency assessment and in-training global assessment scores were examined using risk-adjusted cumulative sum to determine their predictive clinical validity with predefined competent scores of 3 and 5 respectively.RESULTS: 108 Lapco delegates performed 4586 elective colorectal resections pre-Lapco and 5115 post-Lapco while non-Lapco surgeons performed 72930 matched cases. Lapco delegates had a 37.8% increase in laparoscopic surgery which was greater than non-Lapco surgeons by 20.9% (95% CI, 18.5 to 23.3, p [less than] 0.001) with a relative decrease in 30-day mortality by -1.6% (95% CI, -3.4 to -0.2, p = 0.039) and 90-day mortality by -2.3% (95% CI, -4.3 to -0.4, p = 0.018). The change point of risk-adjusted cumulative sum was 3.12 for competency assessment tool and 4.74 for global assessment score whereas laparoscopic rate increased from 44% to 66% and 40% to 56% respectively.CONCLUSIONS: Lapco increased the rate of laparoscopic colorectal cancer surgery and reduced mortality and morbidity in England. In-training competency assessment tools predicted clinical performance after training

    Erratum to: Methods for evaluating medical tests and biomarkers

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    [This corrects the article DOI: 10.1186/s41512-016-0001-y.]

    Evidence synthesis to inform model-based cost-effectiveness evaluations of diagnostic tests: a methodological systematic review of health technology assessments

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    Background: Evaluations of diagnostic tests are challenging because of the indirect nature of their impact on patient outcomes. Model-based health economic evaluations of tests allow different types of evidence from various sources to be incorporated and enable cost-effectiveness estimates to be made beyond the duration of available study data. To parameterize a health-economic model fully, all the ways a test impacts on patient health must be quantified, including but not limited to diagnostic test accuracy. Methods: We assessed all UK NIHR HTA reports published May 2009-July 2015. Reports were included if they evaluated a diagnostic test, included a model-based health economic evaluation and included a systematic review and meta-analysis of test accuracy. From each eligible report we extracted information on the following topics: 1) what evidence aside from test accuracy was searched for and synthesised, 2) which methods were used to synthesise test accuracy evidence and how did the results inform the economic model, 3) how/whether threshold effects were explored, 4) how the potential dependency between multiple tests in a pathway was accounted for, and 5) for evaluations of tests targeted at the primary care setting, how evidence from differing healthcare settings was incorporated. Results: The bivariate or HSROC model was implemented in 20/22 reports that met all inclusion criteria. Test accuracy data for health economic modelling was obtained from meta-analyses completely in four reports, partially in fourteen reports and not at all in four reports. Only 2/7 reports that used a quantitative test gave clear threshold recommendations. All 22 reports explored the effect of uncertainty in accuracy parameters but most of those that used multiple tests did not allow for dependence between test results. 7/22 tests were potentially suitable for primary care but the majority found limited evidence on test accuracy in primary care settings. Conclusions: The uptake of appropriate meta-analysis methods for synthesising evidence on diagnostic test accuracy in UK NIHR HTAs has improved in recent years. Future research should focus on other evidence requirements for cost-effectiveness assessment, threshold effects for quantitative tests and the impact of multiple diagnostic tests

    Erratum to: Methods for evaluating medical tests and biomarkers

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    [This corrects the article DOI: 10.1186/s41512-016-0001-y.]

    Risks of Using Bedside Tests to Verify Nasogastric Tube Position in Adult Patients

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    Nasogastric (NG) tubes are commonly used for enteral feeding. Complications of feeding tube misplacement include malnutrition, pulmonary aspiration, and even death. We built a Bayesian network (BN) to analyse the risks associated with available bedside tests to verify tube position. Evidence on test validity (sensitivity and specificity) was retrieved from a systematic review. Likelihood ratios were used to select the best tests for detecting tubes misplaced in the lung or oesophagus. Five bedside tests were analysed including magnetic guidance, aspirate pH, auscultation, aspirate appearance, and capnography/colourimetry. Among these, auscultation and appearance are non-diagnostic towards lung or oesophagus placements. Capnography/ colourimetry can confirm but cannot rule out lung placement. Magnetic guidance can rule out both lung and oesophageal placement. However, as a relatively new technology, further validation studies are needed. The pH test with a cut-off at 5.5 or lower can rule out lung intubation. Lowering the cut-off to 4 not only minimises oesophageal intubation but also provides extra safety as the sensitivity of pH measurement is reduced by feeding, antacid medication, or the use of less accurate pH paper. BN is an effective tool for representing and analysing multi-layered uncertainties in test validity and reliability for the verification of NG tube position. Aspirate pH with a cut-off of 4 is the safest bedside method to minimise lung and oesophageal misplacement
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