Actual Number Of Events Research Articles

Methodological and Ethical Considerations in Research Involving Adult Survivors of Childhood Sexual Abuse : A Reflection

The number of reported incidents of sexual violence continues to increase in Indonesia, giving rise to deep concerns and calls to prevent sexual violence from occurring in the future. Some experts call it “the Silent Epidemic” because it is estimated that the actual number of events is much higher than reported. Therefore, research on this issue needs to be continued to get input on the cause and effect, impact and prevention efforts. Researches on child sexual abuse and the impact throughout the lives of the survivors is highly important in providing scientific evidences for developing the interventions in social work practice. However, it also comes with very specific challenges when conducting a research on this issue. There are no specific guidelines regarding ethics and methodology in carrying out research on survivors of sexual violence. Therefore, in the future it is important to consider the methodological and ethical aspects before embarking on a research involving survivors of sexual violence. Based on the experience of carrying out this research, the aspects that potentially harm or put participants and researchers at risk can be minimized or even avoided. This experience can also provide reinforcement that research involving trauma survivors can benefit both the affected population as well as social work scientists and practitioners. This manuscript discusses the current thinking on these issues.

Effect of Leptin Therapy on Survival in Generalized and Partial Lipodystrophy: A Matched Cohort Analysis.

ContextData quantifying the impact of metreleptin therapy on survival in non-human immunodeficiency virus (HIV)-related generalized lipodystrophy (GL) and partial lipodystrophy (PL) are unavailable.ObjectiveThis study aimed to estimate the treatment effect of metreleptin on survival in patients with GL and PL.Design/Setting/PatientsDemographic and clinical characteristics were used to match metreleptin-treated and metreleptin-naïve patients with GL and PL. Differences in mortality risk were estimated between matched cohorts of metreleptin-treated and metreleptin-naïve patient cohorts using Cox proportional hazard models. Sensitivity analyses assessed the impact of study assumptions and the robustness of results.Outcome MeasuresThis study assessed time-to-mortality and risk of mortality.ResultsThe analysis evaluated 103 metreleptin-naïve patients with characteristics matched to 103 metreleptin-treated patients at treatment initiation. Even after matching, some metabolic and organ abnormalities were more prevalent in the metreleptin-treated cohort due to bias toward treating more severely affected patients. A Cox proportional hazards model associated metreleptin therapy with an estimated 65% decrease in mortality risk (hazard ratio [HR] 0.348, 95% confidence interval (CI): 0.134–0.900; P = 0.029) even though the actual number of events were relatively small. Results were robust across a broad range of alternate methodological assumptions. Kaplan–Meier estimates of time-to-mortality for the metreleptin-treated and the matched metreleptin-naïve cohorts were comparable.ConclusionsMetreleptin therapy was associated with a reduction in mortality risk in patients with lipodystrophy syndromes despite greater disease severity in treated patients, supporting the view that metreleptin can have a positive disease-modifying impact. Confirmatory studies in additional real-world and clinical datasets are warranted.

FLT3 inhibitors in acute myeloid leukaemia: assessment of clinical effectiveness, adverse events and future research\u2014a systematic review and meta-analysis

BackgroundFMS-like tyrosine kinase 3 (FLT3) is the most frequent mutation in AML. With two FLT3 inhibitors recently approved by the FDA (midostaurin and gilteritinib), there is a need to evaluate these targeted agents.PurposeTo assess the clinical effectiveness of FLT3 inhibitors in AML patients.MethodsStandard systematic review methods were utilised. Searches were conducted to July 2020 for completed and in-progress randomised controlled trials of FLT3 inhibitors in AML. A fixed-effect meta-analysis was undertaken.ResultsEight completed trials involving 2656 patients and assessing five different FLT3 inhibitors (sorafenib, lestaurtinib, midostaurin, gilteritinib and quizartinib) were included. The pooled results were as follows (FLT3 inhibitor/control): overall survival hazard ratio (HR) = 0.83 (95% confidence interval [CI] 0.75 to 0.92, p = 0.0005), event-free survival HR = 0.85 (95% CI 0.77 to 0.94, p = 0.002), relapse-free survival HR = 0.76 (95% CI 0.64 to 0.90, p = 0.001), complete remission relative risk (RR) = 1.11 (95% CI 1.00 to 1.22. p = 0.05) and 60-day mortality RR = 1.04 (95% CI 0.77 to 1.40, p = 0.79).Relative risk of grade 3 and above vascular, dermatological, respiratory and hepatobiliary adverse events were found to be statistically significantly higher in the FLT3 inhibitor group compared to control, but the actual numbers of events were relatively small. Nineteen ongoing trials are still in progress, only one of which specifically targets older patients with AML.ConclusionsThere is evidence to support the use of FLT3 inhibitors in patients with AML, but more data is needed to verify the optimum use of the drugs regarding type of inhibitor, disease stage and patient characteristics, not only in relation to disease control, but adverse events and quality of life. There are a large number of ongoing trials; therefore, the results of this review are not a fait accompli; thus, is it recommended that the review be updated in a couple of years’ time. Given the challenges in extracting the complete data set required to assess clinical effectiveness, it is highly recommended that ongoing and future trials improve transparency and consistency of reporting of all trial outcomes, particularly disease control and adverse events, to enable a global clinical effectiveness assessment.Systematic review registrationPROSPERO CRD42017055581

How to Interpret Patient Safety Data—A Guide From the Nation's Largest Event Reporting Database

Patient safety metrics are recurrent headlines. Intentional or not, they are often sensationalized, conflated, or misconstrued to tell a story in which patients are frequently harmed by irresponsible, negligent clinicians. The truth is far less dramatic. Although medical error does occur and real people suffer real harm, the vast majority of encounters go as expected. So it’s crucial to understand how to interpret patient safety metrics to distinguish true areas of concern from embellished front-page stories. It is also important to understand that each database has its own reporting criteria and each research study its own methodology, and while there is no universal definition for medical error, medical error is not synonymous with patient harm. Reported events do not necessarily equate to instances of medical error, nor are all instances of harm preventable. For example, a patient may have a serious allergic reaction to a medication that they have never taken previously. The Patient Safety Authority (PSA) is charged with capturing every occurrence of harm or potential harm to patients in Pennsylvania, whether attributable to medical error or not, and providing tools to prevent its recurrence. Since its inception in 2004, more than 3.8 million confidential event reports have been added to the PSA’s database, the Pennsylvania Patient Safety Reporting System (PA-PSRS)—the largest event reporting database in the United States and one of the largest in the world. The number of events reported into PA-PSRS has increased from 2004 to 2018; however, this was anticipated as a result of a maturing safety culture, and one cannot conclude from the data whether the actual number of events went up or the uptick is solely due to increased reporting. Caution should be given to inferences like “medical error is increasing” that cannot be substantiated from event reports. It may seem counterintuitive, but a facility with a low number of reports may be more concerning than one with a higher number, as this could indicate a culture where safety and transparency are not supported. What is certain is that since 2004 in Pennsylvania, the number of reported incidents (events without harm) has increased; the number of reported serious events (events with some level of harm) has not trended up or down; and the number of high- harm events (those causing life-threatening injury, irreversible harm, or death) has declined. Approximately 97% of the reports in PA-PSRS are incidents. These types of events are often overlooked in healthcare, as Pennsylvania continues to be the only state that requires healthcare facilities to report no-harm events. Incidents often indicate potential patient harm, and the difference between a “near miss” and a “serious event” may have been happenstance or an intervention not guaranteed to recur. Though PA-PSRS cannot conclusively address medical error incidence, its millions of datapoints provide insights into emerging trends that are unapparent to individual facilities. As such, it provides the framework for a larger system that transforms data into actionable information to reduce harm. Thorough ongoing analyses drive an education agenda, identify opportunities for collaborative improvement projects, and prioritize issues across Pennsylvania and the United States—in healthcare facilities and in individual practice. The PSA’s work in these areas is published and shared in Patient Safety and elsewhere, and read by healthcare providers in 49 states and 44 countries.

A Decade of Preventing Harm

Areas of focus included pressure ulcers, adverse drug events, falls with injury, health care-associated infections, and venous thromboembolism. Initial efforts involved building system-level multidisciplinary teams, utilizing standardized project management methods, and establishing standard surveillance methods. Evidence-based interventions were deployed across the system; core standards were established while allowing for flexibility in local implementation. Improvements were tracked using actual numbers of events rather than rates to increase meaning and interpretability by patients and frontline staff. Over the course of the five-year intervention period, total harm events were reduced by 51.6% (10,371 events in 2009 to 5,018 events in 2012). Continued improvement efforts over the subsequent five years led to additional harm reduction (2,605 events in 2017; a 74.9% reduction since 2009). A combination of project management discipline, rigorous surveillance, and focused interventions, along with system-level support of local hospital improvement efforts, led to dramatic reductions in preventable harm and long-term sustainment of progress.

Phylogenetic Reconstruction for Copy-Number Evolution Problems.

Cancer is known for its heterogeneity and is regarded as an evolutionary process driven by somatic mutations and clonal expansions. This evolutionary process can be modeled by a phylogenetic tree and phylogenetic analysis of multiple subclones of cancer cells can facilitate the study of the tumor variants progression. Copy-number aberration occurs frequently in many types of tumors in terms of segmental amplifications and deletions. In this paper, we developed a distance-based method for reconstructing phylogenies from copy-number profiles of cancer cells. We demonstrate the importance of distance correction from the edit (minimum) distance to the estimated actual number of events. Experimental results show that our approaches provide accurate and scalable results in estimating the actual number of evolutionary events between copy number profiles and in reconstructing phylogenies.

133 Stick and Tell: A Survey of Emergency Medicine Residents and Needlestick Exposures

Study Objectives: An estimated 400,000 to 800,000 needlestick injuries annually in the US involves health care workers. Although percutaneous injury are a common occurrence in the emergency department (ED), there is a large discrepancy between the number of actual events and the events reported to employee health. Despite the potentially serious consequences of percutaneous injury, practitioners often downplay the occurrence and do not report exposures. This study was conducted in order to investigate needlestick incidence and the resident's attitude associated with reporting injuries.

Dynamics of fluid-triggered fracturing in the models of a geological medium

Implications of infusion of small (compared to the pore space) amounts of water for the dynamics of fracturing are studied in the laboratory experiments on the models of a heterogeneous geological medium. Variations in the acoustic emission that precede macrofracture are analyzed, including as candidate precursors. In all experiments, the macrofracture had occurred not immediately after the mechanical loading or water infusion but with a time-delay after a period of acoustic quiescence and subsequent activation. The enhancement in acoustic activity preceding macrofracture is well reproduced by the exponential law; the correlation between the actual number of events (or the released energy) and the exponential approximation exceeds the 95% confidence level. The power law is slightly worse although also a confident approximation of the acoustic emission process. The facts of subsequent occurrence of quiescence and activation suggest that, in principle, this phenomenon can be used as a precursory signature in the prediction of macrofracturing.

Empirical recurrence rate time series for volcanism: Application to Avachinsky volcano, Russia

The volcanic activity of Avachinsky is assumed to follow a Poisson process and is fingerprinted with a sequence of empirical recurrence rate time series. The last 5 time series are used as a prediction set to check the predictive ability of the candidate model produced by time series modeling techniques. The model is used to forecast future recurrence rates that, in turn, are used to develop the mean function of the volcanic process, which is required to evaluate the probability of future eruptions. At the model validation stage, the candidate model forecasts a mean number of 2.31 eruptions for the prediction set that are close to the actual number of events, which are 2 eruptions. For a full scaled forecast, the model concludes a total of 2.37 new events for the next 25 years for the Avachinsky volcano.

Fractures, heart failure and fears of myocardial ischaemia: has the RECORD stuck for rosiglitazone and the thiazolidinediones?

AbstractThiazolidinediones (TZDs) are extensively prescribed worldwide to lower blood glucose levels in type 2 diabetes mellitus (DM). Safety concerns regarding this class of drugs have arisen from a recently published meta‐analysis as well as an underpowered, interim report from the RECORD study group. The meta‐analysis compared treatment with rosiglitazone with other therapies for type 2 DM or placebo, and found that rosiglitazone was associated with a significant increase in the risk of myocardial infarction (MI) and a borderline‐significant finding from death from cardiovascular causes. Though the actual numbers of events were small and the methodology open to criticism, the subsequent early report of the RECORD study also suggests an increased cardiovascular risk. Moreover, the latter study corroborated with data from the previously reported DREAM, ADOPT and PROactive studies in highlighting an increased risk of fluid retention and cardiac failure. Recent data from both animal and human studies have described the detrimental effect of TZD treatment upon bone mineral density in men and women. The rosiglitazone cardiovascular safety data, however, must be considered alongside the benefits ascribed to pioglitazone treatment from the PROactive study in terms of risk reduction of the trial's secondary endpoint of all‐cause mortality, non‐fatal MI and non‐fatal stroke, as well as subsequent data from this trial group in terms of stroke and MI in high‐risk patients with type 2 DM. Further data regarding the safety profile of rosiglitazone are required prior to a definitive conclusion and it may be appropriate, for patients stable on rosiglitazone treatment, to remain on it, but the data should be considered by both the treating physician and the patient. Copyright © 2007 John Wiley & Sons.

An Alarms Climatology of Gulf of California Moisture Surges and the Associated Precipitation, 1993-2004

This study applies the ALARMS (Assessing Low-level AtmospheRic Moisture using Soundings) method to 12 years of data from Phoenix, Arizona; Tucson, Arizona; Yuma, Arizona; and Empalme, Mexico, in order to establish a climatology of low-level moisture surges from the Gulf of California and their effects on precipitation. There are 64 events detected using the available data, and data inventories are used to estimate the actual number of events that occurred at each station for every year. Surge totals are consistent with previous research. Interseasonal variability cannot be significantly related to ENSO, but intraseasonal variability appears to be related to certain phases of the MJO. Composite soundings illustrate the atmospheric profile of typical surges, and it is clear that surface moisture values at Yuma, Arizona, are not consistent with moisture content in the low levels above the surface. Precipitation analyses show that increased low-level moisture significantly increases the amount of rainfall at each gauge as well as the number of stations receiving measurable precipitation. Also, rainfall is more likely on days with higher dewpoints, and gulf surges appear to significantly increase precipitation across the study area.