Synthetic-type control charts for time-between-events monitoring.
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ABSTRACT:
SUBMITTER: Yen FY
PROVIDER: S-EPMC3670912 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveTo determine the effect of introducing prospective monitoring of outcomes using control charts and regular feedback on indicators to surgical teams on major adverse events in patients.DesignNational, parallel, cluster randomised trial embedding a difference-in-differences analysis.Setting40 surgical departments of hospitals across France.Participants155 362 adults who underwent digestive tract surgery. 20 of the surgical departments were randomised to prospective monitoring of outcomes using control charts with regular feedback on indicators (intervention group) and 20 to usual care only (control group).InterventionsProspective monitoring of outcomes using control charts, provided in sets quarterly, with regular feedback on indicators (intervention hospitals). To facilitate implementation of the programme, study champion partnerships were established at each site, comprising a surgeon and another member of the surgical team (surgeon, anaesthetist, or nurse), and were trained to conduct team meetings, display posters in operating rooms, maintain a logbook, and devise an improvement plan.Main outcome measuresThe primary outcome was a composite of major adverse events (inpatient death, intensive care stay, reoperation, and severe complications) within 30 days after surgery. Changes in surgical outcomes were compared before and after implementation of the programme between intervention and control hospitals, with adjustment for patient mix and clustering.Results75 047 patients were analysed in the intervention hospitals (37 579 before and 37 468 after programme implementation) versus 80 315 in the control hospitals (41 548 and 38 767). After introduction of the control chart, the absolute risk of a major adverse event was reduced by 0.9% (95% confidence interval 0.4% to 1.4%) in intervention compared with control hospitals, corresponding to 114 patients (70 to 280) who needed to receive the intervention to prevent one major adverse event. A significant decrease in major adverse events (adjusted ratio of odds ratios 0.89, 95% confidence interval 0.83 to 0.96), patient death (0.84, 0.71 to 0.99), and intensive care stay (0.85, 0.76 to 0.94) was found in intervention compared with control hospitals. The same trend was observed for reoperation (0.91, 0.82 to 1.00), whereas severe complications remained unchanged (0.96, 0.87 to 1.07). Among the intervention hospitals, the effect size was proportional to the degree of control chart implementation witnessed. Highly compliant hospitals experienced a more important reduction in major adverse events (0.84, 0.77 to 0.92), patient death (0.78, 0.63 to 0.97), intensive care stay (0.76, 0.67 to 0.87), and reoperation (0.84, 0.74 to 0.96).ConclusionsThe implementation of control charts with feedback on indicators to surgical teams was associated with concomitant reductions in major adverse events in patients. Understanding variations in surgical outcomes and how to provide safe surgery is imperative for improvements.Trial registrationClinicalTrials.gov NCT02569450.
| S-EPMC7610189 | biostudies-literature
Project description:ObjectivesTo determine whether an innovative graphical tool for accurate measurement of individual surgeon performance metrics, adjusted for both surgeon-specific and patient-specific factors, significantly alters interpretation of performance data.DesignRetrospective analysis of all total knee replacements (TKRs) conducted at the host institution between 1996 and 2009. The database was randomly divided into training and testing datasets. Using multivariate generalised estimating equation regression models, the training dataset enabled generation of patient-risk and surgeon-experience adjustment factors. To simulate prospective monitoring of individual surgeon outcomes, the testing dataset was mapped on control charts. Weighted ? statistics were calculated to measure the agreement between patient-risk adjusted and fully adjusted control charts.SettingTertiary care academic hospital.ParticipantsAll patients undergoing TKR at the host institution 1996-2009.Main outcome measureOperative efficiency.Results5313 procedures were analysed. Adjusted control charts were generated using a training dataset comprising 3756 procedures performed by 13 surgeons. The operative time gradually declined by 121 min with 25 years of experience (p<0.0001). Charts were tested by monitoring four other surgeons, performing an average of 389 procedures each. Adjustment for surgeon experience significantly altered the interpretation of operative efficiency (?=0.29 (95% CI 0.11 to 0.47)), and enhanced assessment of a surgeon's improvement or diminishment in efficiency over time. Specifically, experience adjustment inverted the interpretation of surgeon efficiency from above average to below average, or from improving to declining performance.ConclusionsAdjustment for surgeon experience is necessary for accurate interpretation of metrics over the course of a surgeon's career. Patient-adjusted and surgeon-adjusted control charts provide an accurate method of monitoring individual operative efficiency.
| S-EPMC3902330 | biostudies-literature
Project description:Characterization and standardization of inducible transcriptional regulators has transformed how scientists approach biology by allowing precise and tunable control of gene expression. Despite their utility, only a handful of well-characterized regulators exist, limiting the complexity of engineered biological systems. We apply a characterization pipeline to four genetically encoded sensors that respond to acrylate, glucarate, erythromycin and naringenin. We evaluate how the concentration of the inducing chemical relates to protein expression, how the extent of induction affects protein expression kinetics, and how the activation behavior of single cells relates to ensemble measurements. We show that activation of each sensor is orthogonal to the other sensors, and to other common inducible systems. We demonstrate independent control of three fluorescent proteins in a single cell, chemically defining eight unique transcriptional states. To demonstrate biosensor utility in metabolic engineering, we apply the glucarate biosensor to monitor product formation in a heterologous glucarate biosynthesis pathway and identify superior enzyme variants. Doubling the number of well-characterized inducible systems makes more complex synthetic biological circuits accessible. Characterizing sensors that transduce the intracellular concentration of valuable metabolites into fluorescent readouts enables high-throughput screening of biological catalysts and alleviates the primary bottleneck of the metabolic engineering design-build-test cycle.
| S-EPMC4551912 | biostudies-literature
Project description:BackgroundRecurrent mood episodes and subsyndromal mood instability cause substantial disability in patients with bipolar disorder. Early identification of mood episodes enabling timely mood stabilization is an important clinical goal. This study investigates the ability of control chart methodology to predict manic and/or depressive episodes by applying Shewhart's control rules to weekly self-reported scores from mania and depression questionnaires.MethodsShewhart's control rules were applied to weekly self-reported scores from the Altman Self-Rating Mania Scale (ASRM) and the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS) collected from 2001 to 2012 as part of the OXTEXT programme. Manic and depressive episodes were defined as an ASRM score ≥ 10 or a QIDS score ≥ 15, respectively. An episode-free run-in period of eight consecutive weeks without an episode of either type was used to calibrate control charts. Shewhart's rules were then applied to follow-up data. Their sensitivity and positive predictive value for predicting manic or depressive episodes within the next 4 weeks were calculated focusing on the first episode. Secondary analyses varying control chart type, length of episode-free run-in period, time frames to evaluate diagnostic accuracy, thresholds defining either manic or depressive episodes, and missing data methods were performed.ResultsData from 146 participants (37% men) were included. The mean age was 43.4 (SD = 13.3) years. The median follow-up was 10 (IQR 5-40) weeks for mania and 10 (IQR 5-23) weeks for depression. A total of 53 (36%) participants had a manic episode and 67 (46%) had a depressive episode. For manic episodes, the sensitivity and positive predictive value of Shewhart's control rules were 30% (95% CI 19-45%) and 7% (95% CI 5-9%), and for depressive episodes, 33% (95% CI 22-46%) and 9% (95% CI 6-12%), respectively. Results from secondary analyses were similar to these.ConclusionsTele-monitoring with control rules has the potential to predict about one-third of manic or depressive episodes before they occur, at the cost of a high false positive rate. Given the severe consequences of manic and depressive episodes, this trade-off may be desirable.
| S-EPMC6161980 | biostudies-literature
Project description:ImportanceContinuous glucose monitoring (CGM) is recommended for patients with type 1 diabetes; observational evidence for CGM in patients with insulin-treated type 2 diabetes is lacking.ObjectiveTo estimate clinical outcomes of real-time CGM initiation.Design, setting, and participantsExploratory retrospective cohort study of changes in outcomes associated with real-time CGM initiation, estimated using a difference-in-differences analysis. A total of 41 753 participants with insulin-treated diabetes (5673 type 1; 36 080 type 2) receiving care from a Northern California integrated health care delivery system (2014-2019), being treated with insulin, self-monitoring their blood glucose levels, and having no prior CGM use were included.ExposuresInitiation vs noninitiation of real-time CGM (reference group).Main outcomes and measuresTen end points measured during the 12 months before and 12 months after baseline: hemoglobin A1c (HbA1c); hypoglycemia (emergency department or hospital utilization); hyperglycemia (emergency department or hospital utilization); HbA1c levels lower than 7%, lower than 8%, and higher than 9%; 1 emergency department encounter or more for any reason; 1 hospitalization or more for any reason; and number of outpatient visits and telephone visits.ResultsThe real-time CGM initiators included 3806 patients (mean age, 42.4 years [SD, 19.9 years]; 51% female; 91% type 1, 9% type 2); the noninitiators included 37 947 patients (mean age, 63.4 years [SD, 13.4 years]; 49% female; 6% type 1, 94% type 2). The prebaseline mean HbA1c was lower among real-time CGM initiators than among noninitiators, but real-time CGM initiators had higher prebaseline rates of hypoglycemia and hyperglycemia. Mean HbA1c declined among real-time CGM initiators from 8.17% to 7.76% and from 8.28% to 8.19% among noninitiators (adjusted difference-in-differences estimate, -0.40%; 95% CI, -0.48% to -0.32%; P < .001). Hypoglycemia rates declined among real-time CGM initiators from 5.1% to 3.0% and increased among noninitiators from 1.9% to 2.3% (difference-in-differences estimate, -2.7%; 95% CI, -4.4% to -1.1%; P = .001). There were also statistically significant differences in the adjusted net changes in the proportion of patients with HbA1c lower than 7% (adjusted difference-in-differences estimate, 9.6%; 95% CI, 7.1% to 12.2%; P < .001), lower than 8% (adjusted difference-in-differences estimate, 13.1%; 95% CI, 10.2% to 16.1%; P < .001), and higher than 9% (adjusted difference-in-differences estimate, -7.1%; 95% CI, -9.5% to -4.6%; P < .001) and in the number of outpatient visits (adjusted difference-in-differences estimate, -0.4; 95% CI, -0.6 to -0.2; P < .001) and telephone visits (adjusted difference-in-differences estimate, 1.1; 95% CI, 0.8 to 1.4; P < .001). Initiation of real-time CGM was not associated with statistically significant changes in rates of hyperglycemia, emergency department visits for any reason, or hospitalizations for any reason.Conclusions and relevanceIn this retrospective cohort study, insulin-treated patients with diabetes selected by physicians for real-time continuous glucose monitoring compared with noninitiators had significant improvements in hemoglobin A1c and reductions in emergency department visits and hospitalizations for hypoglycemia, but no significant change in emergency department visits or hospitalizations for hyperglycemia or for any reason. Because of the observational study design, findings may have been susceptible to selection bias.
| S-EPMC8173463 | biostudies-literature
Project description:At the end of December 2019, the world in general and Wuhan, the industrial hub of China, in particular, experienced the COVID-19 pandemic. Massive increment of cases and deaths occurred in China and 209 countries in Europe, America, Australia, Asia and Pakistan. Pakistan was first hit by COVID-19 when a case was reported in Karachi on 26 February 2020. Several methods were presented to model the death rate due to the COVID-19 pandemic and to forecast the pinnacle of reported deaths. Still, these methods were not used in identifying the first day when Pakistan enters or exits the early exponential growth phase. The present study intends to monitor variations in deaths and identify the growth phases such as pre-growth, growth, and post-growth phases in Pakistan due to the COVID-19 pandemic. New approaches are needed that display the death patterns and signal an alarming situation so that corrective actions can be taken before the condition worsens. To meet this purpose, secondary data on daily reported deaths due to the COVID-19 pandemic have been considered, and the $c$ and exponentially weighted moving average (EWMA) control charts are used To meet this purpose, secondary data on daily reported deaths in Pakistan due to the COVID-19 pandemic have been considered. The $ c$ and exponentially weighted moving average (EWMA) control charts have been used for monitoring variations. The chart shows that Pakistan switches from the pre-growth to the growth phase on 31 March 2020. The EWMA chart demonstrates that Pakistan remains in the growth phase from 31 March 2020 to 17 August 2020, with some indications signaling a decrease in deaths. It is found that Pakistan moved to a post-growth phase for a brief period from 27 July 2020 to 28 July 2020. Pakistan switches to re-growth phase with an alarm on 31/7/2020, right after the short-term post-growth phase. The number of deaths starts decreasing in August in that Pakistan may approach the post-growth phase shortly. This amalgamation of control charts illustrates a systematic implementation of the charts for government leaders and forefront medical teams to facilitate the rapid detection of daily reported deaths due to COVID-19. Besides government and public health officials, it is also the public's responsibility to follow the enforced standard operating procedures as a temporary remedy of this pandemic in ensuring public safety while awaiting a suitable vaccine to be discovered.
| S-EPMC8365500 | biostudies-literature
Project description:Limited information is available on what constitutes optimal growth in dogs. The primary aim of this study was to develop evidence-based growth standards for dogs, using retrospective analysis of bodyweight and age data from >6 million young dogs attending a large corporate network of primary care veterinary hospitals across the USA. Electronic medical records were used to generate bodyweight data from immature client-owned dogs, that were healthy and had remained in ideal body condition throughout the first 3 years of life. Growth centile curves were constructed using Generalised Additive Models for Location, Shape and Scale. Curves were displayed graphically as centile charts covering the age range 12 weeks to 2 years. Over 100 growth charts were modelled, specific to different combinations of breed, sex and neuter status. Neutering before 37 weeks was associated with a slight upward shift in growth trajectory, whilst neutering after 37 weeks was associated with a slight downward shift in growth trajectory. However, these shifts were small in comparison to inter-individual variability amongst dogs, suggesting that separate curves for neutered dogs were not needed. Five bodyweight categories were created to cover breeds up to 40kg, using both visual assessment and hierarchical cluster analysis of breed-specific growth curves. For 20/24 of the individual breed centile curves, agreement with curves for the corresponding bodyweight categories was good. For the remaining 4 breed curves, occasional deviation across centile lines was observed, but overall agreement was acceptable. This suggested that growth could be described using size categories rather than requiring curves for specific breeds. In the current study, a series of evidence-based growth standards have been developed to facilitate charting of bodyweight in healthy dogs. Additional studies are required to validate these standards and create a clinical tool for growth monitoring in pet dogs.
| S-EPMC5584974 | biostudies-literature
Project description:The current rise of neurodevelopmental disorders poses a critical need to detect risk early in order to rapidly intervene. One of the tools pediatricians use to track development is the standard growth chart. The growth charts are somewhat limited in predicting possible neurodevelopmental issues. They rely on linear models and assumptions of normality for physical growth data - obscuring key statistical information about possible neurodevelopmental risk in growth data that actually has accelerated, non-linear rates-of-change and variability encompassing skewed distributions. Here, we use new analytics to profile growth data from 36 newborn babies that were tracked longitudinally for 5?months. By switching to incremental (velocity-based) growth charts and combining these dynamic changes with underlying fluctuations in motor performance - as the transition from spontaneous random noise to a systematic signal - we demonstrate a method to detect very early stunting in the development of voluntary neuromotor control and to flag risk of neurodevelopmental derail.
| S-EPMC5120129 | biostudies-literature
Project description:This research aimed to propose a newly-mixed control chart called the Exponentially Weighted Moving Average-Moving Average Chart (EWMA-MA) to detect the mean change in a process underlying symmetric and asymmetric distributions. The performance of the proposed control chart are compared with Shewhart, MA, EWMA, MA-EWMA and EWMA-MA control charts by using average run length (ARL), standard deviation of run length (SDRL), and median run length (MRL) as the criteria for measuring efficiency which evaluated by using Monte Carlo simulation (MC), Moreover, the proposed control chart will be applied to real data. The results of performance comparison showed that the presented control charts performed better detection than the Shewhart, MA, and EWMA charts. However, the results of detection tended to be slower than those for the MA-EWMA chart. The value of ARL1 for the mixed control chart depends on the parameters of the statistics for such control chart. The EWMA-MA chart is a variable following ? and the MA-EWMA chart is varied according to w. From applying the proposed control chart to the data for flow in the Nile River and data of the real GDP growth (%) in the Lebanese economy, it was found to be in accordance with the research results.
| S-EPMC7021313 | biostudies-literature
Project description:Decision-makers need signals for action as the coronavirus disease 2019 (COVID-19) pandemic progresses. Our aim was to demonstrate a novel use of statistical process control to provide timely and interpretable displays of COVID-19 data that inform local mitigation and containment strategies. Healthcare and other industries use statistical process control to study variation and disaggregate data for purposes of understanding behavior of processes and systems and intervening on them. We developed control charts at the county and city/neighborhood level within one state (California) to illustrate their potential value for decision-makers. We found that COVID-19 rates vary by region and subregion, with periods of exponential and non-exponential growth and decline. Such disaggregation provides granularity that decision-makers can use to respond to the pandemic. The annotated time series presentation connects events and policies with observed data that may help mobilize and direct the actions of residents and other stakeholders. Policy-makers and communities require access to relevant, accurate data to respond to the evolving COVID-19 pandemic. Control charts could prove valuable given their potential ease of use and interpretability in real-time decision-making and for communication about the pandemic at a meaningful level for communities.
| S-EPMC8087083 | biostudies-literature