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Nevin Manimala Statistics

Performance assessment of surgical tracking systems based on statistical process control and longitudinal QA

Comput Assist Surg (Abingdon). 2023 Dec;28(1):2275522. doi: 10.1080/24699322.2023.2275522. Epub 2023 Nov 9.

ABSTRACT

A system for performance assessment and quality assurance (QA) of surgical trackers is reported based on principles of geometric accuracy and statistical process control (SPC) for routine longitudinal testing. A simple QA test phantom was designed, where the number and distribution of registration fiducials was determined drawing from analytical models for target registration error (TRE). A tracker testbed was configured with open-source software for measurement of a TRE-based accuracy metric ε and Jitter (J). Six trackers were tested: 2 electromagnetic (EM – Aurora); and 4 infrared (IR – 1 Spectra, 1 Vega, and 2 Vicra) – all NDI (Waterloo, ON). Phase I SPC analysis of Shewhart mean (x¯) and standard deviation (s) determined system control limits. Phase II involved weekly QA of each system for up to 32 weeks and identified Pass, Note, Alert, and Failure action rules. The process permitted QA in <1 min. Phase I control limits were established for all trackers: EM trackers exhibited higher upper control limits than IR trackers in ε (EM: x¯ε 2.8-3.3 mm, IR: x¯ε 1.6-2.0 mm) and Jitter (EM: x¯jitter 0.30-0.33 mm, IR: x¯jitter 0.08-0.10 mm), and older trackers showed evidence of degradation – e.g. higher Jitter for the older Vicra (p-value < .05). Phase II longitudinal tests yielded 676 outcomes in which a total of 4 Failures were noted – 3 resolved by intervention (metal interference for EM trackers) – and 1 owing to restrictive control limits for a new system (Vega). Weekly tests also yielded 40 Notes and 16 Alerts – each spontaneously resolved in subsequent monitoring.

PMID:37942523 | DOI:10.1080/24699322.2023.2275522

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Nevin Manimala Statistics

Meta-analysis of the Prognostic Value of microRNA-22 in Leukemia Patients

Technol Cancer Res Treat. 2023 Jan-Dec;22:15330338231212309. doi: 10.1177/15330338231212309.

ABSTRACT

Objective: The pathogenesis of leukemia is complex and there are no effective diagnostic and prognostic indicators. Previous studies showed that microRNA-22 (miR-22) has altered expression level in multiple leukemia subtypes, which is associated with the survival outcomes of leukemia. Methods: According to the constituted retrieval strategy, eligible studies were included from January 2010 to November 2022 by searching database. The pooled Risk Ratio (RR) and 95% confidence intervals (CI) were used to study the relationship between miR-22 and survival. Stata12.0 was used for meta-analysis. Differential expression analysis was conducted based on expression profile of miRNA. Results: Four English articles were included containing a total of 215 leukemia patients. Data showed that the pooled RR for overall survival (OS) was 1.558 (95% CI: 1.197-2.028, P < .01). Subgroup analysis for OS of acute myeloid leukemia patients and the RFS of plasma cell leukemia patients were statistically significant with different expression levels of miR-22 (RR:1.495, 95%CI:1.141-1.958, P < .01 and RR:1.517, 95%CI:1.114-2.065, P < .01, respectively). Moreover, all data included had no significant heterogeneity and publication bias. Conclusions: miR-22 is associated with the survival outcome of leukemia patients suggesting that miR-22 may be a promising prognostic biomarker for this patient population, and the expression level of miR-22 in ALL patients down-regulated.

PMID:37942522 | DOI:10.1177/15330338231212309

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Nevin Manimala Statistics

Optimizing electronic blood ordering and supporting administration workflows to improve blood utilization in the pediatric hospital setting

Transfusion. 2023 Nov 9. doi: 10.1111/trf.17587. Online ahead of print.

ABSTRACT

BACKGROUND: Red blood cell wastage occurs when blood is discarded rather than transfused, and ineffective ordering results in unnecessary crossmatch procedures. We describe how a multimodal approach to redesigning electronic ordering tools improved blood utilization in a pediatric inpatient setting and how using innovative application of time series data analysis provides insights into intervention effectiveness, which can guide future process improvement cycles.

METHODS: A multidisciplinary team used best practices and Toyota Production System methodology to redesign electronic blood ordering and improve administration processes. We analyzed crossmatch to transfusion ratio and red blood cell wastage time series data extracted from our laboratory information system and electronic health record. We used changepoint analysis to identify statistically discernible breaks in each time series, compatible with known interventions. We performed causal impact analysis on red blood cell wastage time series data to estimate blood wastage avoided due to the interventions.

RESULTS: Changepoint analysis estimated an 11% decrease in crossmatch to transfusion ratio and a 77% decrease in red blood cell monthly wastage rate during the intervention period. Causal impact analysis estimated a 61% reduction in expected wastage compared to the scenario if the interventions had not occurred.

DISCUSSION: Our results show that electronic health record design is an important factor in reducing waste and preventing unnecessary crossmatching, and that time series analysis can be a useful tool for evaluating the long-term impact of each stage of intervention in a longitudinal process redesign effort for the purpose of effectively targeting future improvement efforts.

PMID:37942518 | DOI:10.1111/trf.17587

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Nevin Manimala Statistics

A Prospective Study of Stroke Characteristics, Risk Factors, and Mortality in a Tertiary Hospital of Northern Ethiopia

Int J Gen Med. 2023 Nov 3;16:5051-5061. doi: 10.2147/IJGM.S433353. eCollection 2023.

ABSTRACT

BACKGROUND: As developing countries experience the epidemiologic transition to chronic diseases, morbidity and mortality from stroke is expected to rise. Stroke and other non-communicable diseases are increasing in Ethiopia but prospective data are scarce and there are not enough data regarding the characteristics, risk factors and mortality of stroke.

OBJECTIVE: Aimed at determining the risk factors, clinical profiles and treatment outcomes of stroke admissions in Ayder Comprehensive Specialized Hospital, Tigray, Ethiopia.

METHODS: This is a prospective cross-sectional study of all adult stroke patients admitted over consecutive 12 months period in medical ward and ICU of Ayder Comprehensive sSpecialized Hospital, northern Ethiopia. Medical residents through a pre-designed questionnaire collected data. Monovariate analysis, bivariate analysis and multivariate analysis to control for confounder variables were done using software SPSS version 26. P < 0.05 was considered statistically significant.

RESULTS: There were 272 stroke admissions to medical ward and ICU over the 1-year period. Stroke comprised 13.05% of total medical admissions. Ischemic stroke accounted for 62.9% of stroke admissions. Stroke in the young accounted for 14.7% of all stroke admissions. Hypertension was the most common risk factor identified, found in 51.8%. Diabetes mellitus and atrial fibrillation were the other common risk factors. The in-hospital mortality was 13.6%. The only independent predictor of mortality identified was presence of complications, AOR [95% CI] of 2.4 [1.4, 5.3], P-value of 0.028. Aspiration pneumonia was the most common complication.

CONCLUSION: This study showed a high burden of stroke among medical admissions in northern Ethiopia. Being the most common risk factor for stroke, the high burden of undiagnosed and untreated hypertension needs special attention and efforts on community awareness should be enhanced. The relatively higher mortality illustrates the need to establish stroke centers to enhance the quality of stroke care.

PMID:37942476 | PMC:PMC10629449 | DOI:10.2147/IJGM.S433353

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Nevin Manimala Statistics

Creation of a data commons for substance misuse related health research through privacy-preserving patient record linkage between hospitals and state agencies

JAMIA Open. 2023 Nov 2;6(4):ooad092. doi: 10.1093/jamiaopen/ooad092. eCollection 2023 Dec.

ABSTRACT

OBJECTIVES: Substance misuse is a complex and heterogeneous set of conditions associated with high mortality and regional/demographic variations. Existing data systems are siloed and have been ineffective in curtailing the substance misuse epidemic. Therefore, we aimed to build a novel informatics platform, the Substance Misuse Data Commons (SMDC), by integrating multiple data modalities to provide a unified record of information crucial to improving outcomes in substance misuse patients.

MATERIALS AND METHODS: The SMDC was created by linking electronic health record (EHR) data from adult cases of substance (alcohol, opioid, nonopioid drug) misuse at the University of Wisconsin hospitals to socioeconomic and state agency data. To ensure private and secure data exchange, Privacy-Preserving Record Linkage (PPRL) and Honest Broker services were utilized. The overlap in mortality reporting among the EHR, state Vital Statistics, and a commercial national data source was assessed.

RESULTS: The SMDC included data from 36 522 patients experiencing 62 594 healthcare encounters. Over half of patients were linked to the statewide ambulance database and prescription drug monitoring program. Chronic diseases accounted for most underlying causes of death, while drug-related overdoses constituted 8%. Our analysis of mortality revealed a 49.1% overlap across the 3 data sources. Nonoverlapping deaths were associated with poor socioeconomic indicators.

DISCUSSION: Through PPRL, the SMDC enabled the longitudinal integration of multimodal data. Combining death data from local, state, and national sources enhanced mortality tracking and exposed disparities.

CONCLUSION: The SMDC provides a comprehensive resource for clinical providers and policymakers to inform interventions targeting substance misuse-related hospitalizations, overdoses, and death.

PMID:37942470 | PMC:PMC10629613 | DOI:10.1093/jamiaopen/ooad092

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Nevin Manimala Statistics

Impact of Heating Exposure on the Micro-Push-Out Bond Strength of Bioceramic Sealers

Int J Dent. 2023 Oct 31;2023:3327275. doi: 10.1155/2023/3327275. eCollection 2023.

ABSTRACT

INTRODUCTION: The aim of this study was to evaluate the effect of heating of bioceramic and epoxy resin-based sealers on their micro-push-out bond strength (BS) to root canal dentin.

METHODS: After criterial selection, 30 human teeth were decoronated and 1-mm thick slices (n = 60) were obtained perpendicularly along tooth axis, from cervical and middle root thirds, with a diamond disc attached to a cutting machine. In each slice, three 1.0-mm diameter orifices were made. After rinsing with 17% EDTA and 2.5% NaOCl, each orifice was filled with Bio-C Sealer or BioRoot RCS or AH Plus, according to the manufacturers’ instructions. After filling, half of the slices (n = 30) were heated at 100°C for 1 min, and the other half were kept at room temperature. After 7 days-controlled storage, micro-push-out test was performed in a Universal Testing Machine. Failures were analyzed using a stereomicroscope. Statistical analysis was performed with One-Way ANOVA and post hoc Tukey (α = 5%) tests.

RESULTS: AH Plus demonstrated higher BS values after heating (p=0.001) when compared to nonheated. The other sealers did not show a statistically significant difference (p > 0.05). When heated, the average BS values for AH Plus were higher than for BioRoot RCS and Bio-C Sealer (p < 0.001). Cohesive failure mode was the most frequent, followed by adhesive and mixed ones.

CONCLUSION: Heating provided a higher push-out BS to root dentin for AH Plus and did not influence BioRoot RCS or Bio-C sealer.

PMID:37942468 | PMC:PMC10630006 | DOI:10.1155/2023/3327275

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Nevin Manimala Statistics

Effect of Swine Glyco-humanized Polyclonal Neutralizing Antibody on Survival and Respiratory Failure in Patients Hospitalized With Severe COVID-19: A Randomized, Placebo-Controlled Trial

Open Forum Infect Dis. 2023 Oct 20;10(11):ofad525. doi: 10.1093/ofid/ofad525. eCollection 2023 Nov.

ABSTRACT

BACKGROUND: We evaluated the safety and efficacy of XAV-19, an antispike glyco-humanized swine polyclonal neutralizing antibody in patients hospitalized with severe coronavirus disease 2019 (COVID-19).

METHODS: This phase 2b clinical trial enrolled adult patients from 34 hospitals in France. Eligible patients had a confirmed diagnosis of severe acute respiratory syndrome coronavirus 2 within 14 days of onset of symptoms that required hospitalization for low-flow oxygen therapy (<6 L/min of oxygen). Patients were randomly assigned to receive a single intravenous infusion of 2 mg/kg of XAV-19 or placebo. The primary end point was the occurrence of death or severe respiratory failure between baseline and day 15.

RESULTS: Between January 12, 2021, and April 16, 2021, 398 patients were enrolled in the study and randomly assigned to XAV-19 or placebo. The modified intention-to-treat population comprised 388 participants who received full perfusion of XAV-19 (199 patients) or placebo (189 patients). The mean (SD) age was 59.8 (12.4) years, 249 (64.2%) individuals were men, and the median time (interquartile range) from symptom onset to enrollment was 9 (7-10) days. There was no statistically significant decrease in the cumulative incidence of death or severe respiratory failure through day 15 in the XAV-19 group vs the placebo group (53/199 [26.6%] vs 48/189 [25.4%]; adjusted risk difference, 0.6%; 95% CI, -6% to 7%; hazard ratio, 1.03; 95% CI, 0.64-1.66; P = .90). In the safety population, adverse events were reported in 75.4% of 199 patients in the XAV-19 group and in 76.3% of 190 patients in the placebo group through D29.

CONCLUSIONS: Among patients hospitalized with COVID-19 requiring low-flow oxygen therapy, treatment with a single intravenous dose of XAV-19, compared with placebo, did not show a significant difference in terms of disease progression at day 15.

PMID:37942459 | PMC:PMC10629360 | DOI:10.1093/ofid/ofad525

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The Cambridge Experience with Lower Limb Long Bone Non-union Following Fixation and the Treatment Algorithm

Strategies Trauma Limb Reconstr. 2023 May-Aug;18(2):100-105. doi: 10.5005/jp-journals-10080-1589.

ABSTRACT

AIM: Non-unions have been traditionally classified as atrophic, oligotrophic and hypertrophic and their management was primarily dictated by that. In our Unit, we have based our treatment rationale mainly on the stability of the metalwork and the presence of symptoms rather than the radiologic appearance of the non-union or the presence of infection. The aim was to present the treatment algorithm for lower limb long bone non-union following operative fixation.

MATERIALS AND METHODS: All patients treated for a femoral or tibial non-union following fixation between 2014 and 2020 in our unit and with a minimum follow-up of 2 years were included. Non-union was defined as having no evidence of fracture healing in any cortices six months after the index procedure. Union was defined as bridging callus in at least three cortices visualized on at least two orthogonal radiographs. Information retrieved included demographic and fracture characteristics, presence of infection, evidence of metalwork stability and treatment. Outcome measures included union rate, time to union and complications. Data were analysed with the Statistical Program for Social Sciences (SPSS) using contingency tables and linear regression. A p-value of less than 0.05 was considered statistically significant.

RESULTS: Seventy-seven consecutive patients were included in the study. Union was achieved in 91% of the cases, while union was noted in all the patients treated non-operatively. The mean time to union was 14.49 months (9.98). Complications were encountered in 20 of the patients and the most common were docking site non-union and metalwork breakage. Infection was the only factor that affected time to union in a statistically significant manner (p = 0.006).

CONCLUSION: The results of our study suggest that in cases of long bone non-union following operative fixation using signs of metalwork instability and the presence of clinical symptoms as the main indication for surgical intervention provides a satisfactory outcome. This approach prevented operative management in a large proportion of patients.

CLINICAL SIGNIFICANCE: This article presents an algorithmic approach that could aid clinicians in their decision-making in long-bone non-union management.

LEVEL OF EVIDENCE: Therapeutic level III.

HOW TO CITE THIS ARTICLE: Poutoglidou F, Krkovic M. The Cambridge Experience with Lower Limb Long Bone Non-union Following Fixation and the Treatment Algorithm. Strategies Trauma Limb Reconstr 2023;18(2):100-105.

PMID:37942431 | PMC:PMC10628614 | DOI:10.5005/jp-journals-10080-1589

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Nevin Manimala Statistics

Circumferential Periosteal Release to Treat Paediatric Leg Length Discrepancy: Medium Term Outcomes

Strategies Trauma Limb Reconstr. 2023 May-Aug;18(2):67-72. doi: 10.5005/jp-journals-10080-1591.

ABSTRACT

AIMS: This study aims to report the medium term outcomes of circumferential periosteal release of the distal femur and distal tibia in treating paediatric leg length discrepancy (LLD).

MATERIALS AND METHODS: A retrospective case series was performed on all patients undergoing circumferential periosteal release of the distal femur and/or tibia between 2006 and 2019. Data collected included demographics, surgical indications, post-operative leg lengths, and complications. Leg length discrepancy was calculated as actual values and percentages of the longest limb length. Final actual and percentage discrepancies were compared to initial discrepancies using a paired t-test. Patterns of discrepancy over time were analysed using linear mixed models.

RESULTS: Eighteen patients (11 males) were identified, who underwent 25 procedures. The mean age at first surgery was 5.8 (range, 2-13). The commonest indication was congenital limb deficiency (7 patients). Five patients underwent repeat periosteal release, and one patient had three releases. The mean follow-up was 63 months [standard deviation (SD), 33.9]. Fifteen patients had sufficient data for statistical analysis.The mean actual discrepancy decreased from 2.07 cm (SD, 1.07) to 1.12 cm (SD, 1.62), and the mean relative discrepancy from 4.3% (SD, 2.8) to 1.5% (SD, 2.4). Significant mean reductions were seen in both actual discrepancies [0.61 cm (95% CI: 0.05-1.16; p = 0.034)], and percentage discrepancy [2.10% (95% CI: 1.0-3.1, p = <0.001]). In five patients, the operated limb overgrew the contralateral limb. Patients whose operated limb overgrew still had a reduction in LLD, with a mean residual discrepancy less than 1 cm (mean 0.7 cm, 95% CI: From -0.9 to 2.4).

CONCLUSION: Circumferential periosteal release produces a significant decrease in both actual and percentage LLD. We believe this procedure is best indicated in younger patients with congenital LLD in whom the discrepancy is predicted to increase as they age.

CLINICAL SIGNIFICANCE: Circumferential periosteal release produces a significant decrease in LLD. This procedure can be used to manage symptoms during growth, particularly at the point where orthotic usage may become problematic, and to potentially reduce the magnitude of surgery needed at an older age.

HOW TO CITE THIS ARTICLE: Chatterton BD, Kuiper JH, Williams DP. Circumferential Periosteal Release to Treat Paediatric Leg Length Discrepancy: Medium Term Outcomes. Strategies Trauma Limb Reconstr 2023;18(2):67-72.

PMID:37942428 | PMC:PMC10628615 | DOI:10.5005/jp-journals-10080-1591

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Nevin Manimala Statistics

Impact of Test Instructions on 6-min Walk Distance in Adults With Chronic Respiratory Disease: A RANDOMIZED CONTROLLED TRIAL

J Cardiopulm Rehabil Prev. 2023 Nov 8. doi: 10.1097/HCR.0000000000000836. Online ahead of print.

ABSTRACT

PURPOSE: The 6-min walk test (6MWT) is commonly used to assess functional exercise capacity in people with chronic respiratory disease in both clinical and research settings. However, two tests are required to achieve accurate results, due to a well-documented learning effect for the 6-min walk distance (6MWD). Whether it is possible to reduce or eliminate the learning effect by optimizing 6MWT instructions is not known.

METHODS: People with chronic respiratory disease referred to pulmonary rehabilitation undertook two 6MWT with random allocation to modified instructions (fast-walk as fast as possible; n = 46) or usual instructions (far-walk as far as possible; n = 49). The primary outcome was the learning effect, defined as the difference in the 6MWD between test one and test two. Subgroup analyses investigated whether effects varied in those who were naïve to the 6MWT or according to diagnosis (chronic obstructive pulmonary disease, interstitial lung disease, and bronchiectasis).

RESULTS: A learning effect was present in both groups, with a mean improvement in the 6MWD on the second test of 14 m in the fast (modified) group (95% CI, 6-22) and 11 m in the far (usual) group (95% CI, 4-19). There was no statistically or clinically significant difference between groups in the magnitude of the learning effect (between-group difference -3 m, 95% CI, -14 to 8). There was no significant effect of naivety to the 6MWT or diagnosis.

CONCLUSION: The current recommended procedures for the 6MWT, including standardized instructions and performance of two tests on each occasion, should be retained.

PMID:37941096 | DOI:10.1097/HCR.0000000000000836