Category: Statistics

J Cyst Fibros. 2024 Mar 14:S1569-1993(24)00030-4. doi: 10.1016/j.jcf.2024.03.002. Online ahead of print.

ABSTRACT

BACKGROUND: Iron deficiency (ID) is a common extrapulmonary manifestation in cystic fibrosis (CF). CF transmembrane conductance regulator (CFTR) modulator therapies, particularly highly-effective modulator therapy (HEMT), have drastically improved health status in a majority of people with CF. We hypothesize that CFTR modulator use is associated with improved markers of ID.

METHODS: In a multicenter retrospective cohort study across 4 United States CF centers 2012-2022, the association between modulator therapies and ID laboratory outcomes was estimated using multivariable linear mixed effects models overall and by key subgroups. Summary statistics describe the prevalence and trends of ID, defined a priori as transferrin saturation (TSAT) <20 % or serum iron <60 μg/dL (<10.7 μmol/L).

RESULTS: A total of 568 patients with 2571 person-years of follow-up were included in analyses. Compared to off modulator therapy, HEMT was associated with +8.4 % TSAT (95 % confidence interval [CI], +6.3-10.6 %; p < 0.0001) and +34.4 μg/dL serum iron (95 % CI, +26.7-42.1 μg/dL; p < 0.0001) overall; +5.4 % TSAT (95 % CI, +2.8-8.0 %; p = 0.0001) and +22.1 μg/dL serum iron (95 % CI, +13.5-30.8 μg/dL; p < 0.0001) in females; and +11.4 % TSAT (95 % CI, +7.9-14.8 %; p < 0.0001) and +46.0 μg/dL serum iron (95 % CI, +33.3-58.8 μg/dL; p < 0.0001) in males. Ferritin was not different in those taking modulator therapy relative to off modulator therapy. Hemoglobin was overall higher with use of modulator therapy. The prevalence of ID was high throughout the study period (32.8 % in those treated with HEMT).

CONCLUSIONS: ID remains a prevalent comorbidity in CF, despite availability of HEMT. Modulator use, particularly of HEMT, is associated with improved markers for ID (TSAT, serum iron) and anemia (hemoglobin).

PMID:38490920 | DOI:10.1016/j.jcf.2024.03.002

J Cardiothorac Vasc Anesth. 2024 Feb 22:S1053-0770(24)00124-1. doi: 10.1053/j.jvca.2024.02.027. Online ahead of print.

ABSTRACT

OBJECTIVES: To quantify and compare the emissions for deep sedation with total intravenous anesthesia (TIVA) and general anesthesia with inhaled agents during the transcatheter aortic valve replacement procedure.

DESIGN: A retrospective study.

SETTING: A tertiary hospital in Boston, Massachusetts.

PARTICIPANTS: The anesthesia records of 604 consecutive patients who underwent the transcatheter aortic valve replacement procedure between January 1, 2018, and March 31, 2022, were reviewed and analyzed.

INTERVENTIONS: Data were examined and compared in the following 2 groups: general anesthesia with inhaled agents and deep sedation with TIVA.

MEASUREMENTS AND MAIN RESULTS: The gases, drugs, airway management devices, and anesthesia machine electricity were collected and converted into carbon dioxide emissions (CO₂e). The carbon emissions of intravenous medications were converted with the CO₂e data for anesthetic pharmaceuticals from the Parvatker et al. study. For inhaled agents, inhaled anesthetics and oxygen/air flow rate were collected at 15-minute intervals and calculated using the anesthetic gases calculator provided by the Association of Anesthetists. The airway management devices were converted based on life-cycle assessments. The electricity consumed by the anesthesia machine during general anesthesia was estimated from the manufacturer’s data (Dräger, GE) and local Energy Information Administration data. The data were analyzed in the chi-squared test or Wilcoxon rank-sum test. There were no significant differences in the patients’ demographic characteristics, such as age, sex, weight, height, and body mass index. The patients who received general anesthesia with inhaled agents had statistically higher total CO₂e per case than deep sedation with TIVA (16.188 v 1.518 kg CO₂e; p < 0.001), primarily due to the inhaled agents and secondarily to airway management devices. For deep sedation with TIVA, the major contributors were intravenous medications (71.02%) and airway management devices (16.58%). A subgroup study of patients who received sevoflurane only showed the same trend with less variation.

CONCLUSIONS: The patients who received volatile anesthesia were found to have a higher CO₂e per case. This difference remained after a subgroup analysis evaluating those patients only receiving sevoflurane and after accounting for the differences in the duration of anesthesia. Data from this study and others should be collectively considered as the healthcare profession aims to provide the best care possible for their patients while limiting the harm caused to the environment.

PMID:38490897 | DOI:10.1053/j.jvca.2024.02.027

Eur Urol. 2024 Mar 14:S0302-2838(24)00052-6. doi: 10.1016/j.eururo.2024.01.017. Online ahead of print.

ABSTRACT

BACKGROUND: Magnetic resonance imaging (MRI) and targeted biopsies reduce overdiagnosis of prostate cancer (PC). It is uncertain how this strategy performs for low prostate-specific antigen (PSA) levels.

OBJECTIVE: To investigate the Prostate Imaging Reporting and Data System (PI-RADS) distribution, frequency, and characteristics of screen-detected PC with PSA of 1.8-<3 ng/ml and 3-<10 ng/ml.

DESIGN, SETTING, AND PARTICIPANTS: In the population-based Göteborg-2 screening study, 17974 men choose to participate by having a PSA test (2015-2020). One-third of the participants (n = 6006) were randomized to arm 3, men with a PSA value of ≥1.8 ng/ml were recommended for MRI. Men with positive MRI (PI-RADS 3-5) had four targeted biopsies from each MRI-visible lesion.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Clinically significant PC was defined as Gleason score ≥3 + 4.

RESULTS AND LIMITATIONS: A total of 6006 men were included. The median age was 55.9 yr (interquartile range [IQR] 52.6-59.6). Of them, 4929 (82%) had PSA of <1.8 ng/ml, 670 (11%) had PSA of 1.8-<3 ng/ml (low-PSA group, median PSA 2.1 ng/ml [IQR 1.9-2.5]), and 377 (6.3%) had PSA of 3-<10 ng/ml (high-PSA group, median PSA 3.9 ng/ml [IQR 3.3-5.0]). PI-RADS scores of 3, 4, and 5 were observed in 7.8%, 15%, and 1.0% of men in the low-PSA group, and in 6.9%, 17%, and 5.3% of men in the high-PSA group, respectively. PC was found in 64 men (41%, 95% confidence interval [CI] 0.33-0.49) with positive MRI findings in the low-PSA group, of whom 33 (21%) had Gleason 6 (insignificant PC) and 31 (20%) had Gleason ≥7 (significant PC). In the high-PSA group, PC was detected in 61 men (56%, 95% CI 0.46-0.66), of whom 26 (24%) had Gleason 6 (insignificant PC) and 35 (32%) had Gleason ≥7 (significant PC). Limitations include results from only a single screening round.

CONCLUSIONS: A non-negligible number of men with PSA 1.8-3 ng/ml have clinically significant PC. Whether a delay in the diagnosis of these tumors until they reached PSA ≥3 ng/ml would impair their chance of cure remains to be evaluated.

PATIENT SUMMARY: We studied screening using prostate-specific antigen (PSA) and magnetic resonance imaging in men with PSA 1.8-3 ng/ml. We found a non-negligible number of potentially harmful prostate cancers in these men.

PMID:38490856 | DOI:10.1016/j.eururo.2024.01.017

Injury. 2024 Mar 3:111487. doi: 10.1016/j.injury.2024.111487. Online ahead of print.

ABSTRACT

OBJECTIVES: Open tibial fractures are relatively common injuries following traffic accidents. The vulnerability of the soft tissues surrounding the tibia increases the susceptibility to complications, including infection and nonunion. To minimize complications, a multidisciplinary, timely approach is crucial. To date, the Dutch incidence and level of hospital treatment remain unknown due to a lack of condition-specific nationwide registries. This study aimed to estimate the incidence and management of open tibial fractures in the Netherlands, providing essential information for public health policymaking and guideline development.

METHODS: The 2018 and 2019 Dutch National Hospital Care Basic Registration data, provided by the Dutch Hospital Data Foundation, were utilized to identify all patients admitted to Dutch hospitals with tibial fractures. Incidence rates, patient demographics, primary diagnoses, fracture classification, level of hospital, and length of hospital stays were analyzed using descriptive statistics.

RESULTS: 1,079 ICD-10 codes for closed and open tibial fractures were identified in patients that were admitted to a Dutch hospital. Thirty-four percent were classified as open tibial fractures, accounting for an estimated incidence rate of 1.1 per 100,000 person-years (95 % CI 0.97-1.12). When categorized by age, the calculated incidence rate was higher in males for all age categories up until the age of 70. Notably, the overall highest incidence rate was found for females aged 90 and above (6.6 per 100,000 person-years). Open tibial fractures were predominantly treated in general or top clinical hospitals (comprising 69 % of open all tibia fractures). Notably, the minority (31 %) presented at university medical centers, all Level-1 trauma centers, equipped with orthoplastic teams.

CONCLUSION: This is the first study to report the nationwide incidence rate of open tibial fractures in the Netherlands; 34 % of tibial fractures were registered as open. Notably, a limited proportion of open tibial fractures underwent treatment within Level-1 trauma centers. Consequently, in the majority of cases, the implementation of an orthoplastic team approach was unattainable. This study underscores the need for more comprehensive data collection to assess and improve the current treatment landscape.

PMID:38490848 | DOI:10.1016/j.injury.2024.111487

Burns. 2024 Mar 1:S0305-4179(24)00069-X. doi: 10.1016/j.burns.2024.02.027. Online ahead of print.

ABSTRACT

INTRODUCTION: One of the most common traumatic injuries, burn injuries lead to at least 180,000 deaths each year worldwide. Massive burns result in severe tissue loss and increase the rate of infection. Eschar excision with skin grafting is the gold standard of treatments for massive burns. Retaining dermis tissue is the key to ensuring the survival of skin grafts and rapidly closing exposed tissues. Traditional eschar excision with Humby or Weck knife controls the depth of excision until the dermis, but ensuring the accuracy of excision is challenging. Hydrosurgery minimizes damage to uninjured tissues during the removal of necrotic tissues. A foot pedal is used to adjust debridement depth for precise debridement. To figure out the clinical advantages and risks of using hydrosurgery in treating massive burns, this study has been conducted.

METHOD: Forty-two patients with massive burns and total body surface area (TBSA) of > 30% were treated at the First Affiliated Hospital of Anhui Medical University from May 2020 to January 2023. They underwent hydrosurgical eschar excision with MEEK microskin graft (n = 23) or tangential excision with MEEK microskin graft (n = 19).

RESULT: No statistically significant differences (p > 0.05) in the following demographics were found between the two groups: age, weight, TBSA, deep-partial-thickness burn, gender, inhalation injury, shock, excision area, and MEEK ratio. By contrast, statistically significant differences in per unit area of operation time, per unit area of operation spending, hospitalization cost, hospitalization duration, wound-healing time, skin graft survival, and scar quality were found between hydrosurgical excision group with MEEK microskin graft and conventional excision group with MEEK microskin graft.

CONCLUSION: The hydrosurgical excision system showed better clinical effects for patients with massive burns.

PMID:38490834 | DOI:10.1016/j.burns.2024.02.027

Transplant Proc. 2024 Mar 14:S0041-1345(24)00030-7. doi: 10.1016/j.transproceed.2024.01.021. Online ahead of print.

ABSTRACT

BACKGROUND: Various induction regimens are available for kidney transplantation (KT); however, which is superior remains unclear. Moreover, although the induction regimens are effective and important for reducing side effects, their respective relationships with antibody-mediated rejection (AMR) after transplantation remain unclear. Therefore, this study aimed to elucidate the most effective induction regimen for AMR reduction through network analysis.

METHODS: We performed a comprehensive search of databases, including basiliximab, alemtuzumab, antithymocyte globulin (ATG), and daclizumab as induction regimens for KT from inception to September 1, 2022. Using a network meta-analysis, we investigated the priorities of 5 induction regimens for patient survival, graft failure, and graft rejection after ABO-incompatible KT.

RESULTS: In total, 25 studies comprising 1768 people were included in this network meta-analysis. The primary outcome was the AMR rate of other induction regimens compared with that of basiliximab, whereas the secondary outcomes were heart failure, stroke, hospitalization, peripheral artery disease, myocardial infarction, anemia, leukopenia, herpes zoster, or adverse events. Notably, ATG reduced the AMR rate by 59% (odds ratio, 0.41; 95% credible interval, 0.20-0.90), whereas the other drugs did not show statistical significance. Furthermore, secondary outcomes did not significantly differ between the induction regimens.

CONCLUSION: ATG is widely used in KT induction regimens. Our results showed that ATG reduced the risk of AMR in KT recipients when compared with other induction drugs; therefore, it appears to be an efficient choice of induction regimen to reduce AMR after KT.

PMID:38490831 | DOI:10.1016/j.transproceed.2024.01.021

Vaccine. 2024 Mar 14:S0264-410X(24)00195-6. doi: 10.1016/j.vaccine.2024.02.036. Online ahead of print.

ABSTRACT

OBJECTIVE: To determine the effect of SARS-CoV-2 variants on non-respiratory features of COVID-19 in vaccinated and not fully vaccinated patients using a University of California database.

METHODS: A longitudinal retrospective review of medical records (n = 63,454) from 1/1/2020-4/26/2022 using the UCCORDS database was performed to compare non-respiratory features, vaccination status, and mortality between variants. Chi-square tests were used to study the relationship between categorical variables using a contingency matrix.

RESULTS: Fever was the most common feature across all variants. Fever was significantly higher in not fully vaccinated during the Delta and Omicron waves (p = 0.001; p = 0.001). Cardiac features were statistically higher in not fully vaccinated during Omicron; tachycardia was only a feature of not fully vaccinated during Delta and Omicron; diabetes and GI reflux were features of all variants regardless of vaccine status. Odds of death were significantly increased among those not fully vaccinated in the Delta and Omicron variants (Delta OR: 1.64, p = 0.052; Omicron OR: 1.96, p < 0.01). Vaccination was associated with a decrease in the frequency of non-respiratory features.

CONCLUSIONS: Risk of non-respiratory features of COVID-19 is statistically higher in those not fully vaccinated across all variants. Risk of death and correlation with vaccination status varied.

PMID:38490824 | DOI:10.1016/j.vaccine.2024.02.036

J Magn Reson Imaging. 2024 Mar 15. doi: 10.1002/jmri.29357. Online ahead of print.

ABSTRACT

BACKGROUND: Portal vein thrombosis (PVT) is thought to arise from stagnant blood flow, yet conclusive evidence is lacking. Relative residence time (RRT) assessed using 4D Flow MRI may offer insight into portal flow stagnation.

PURPOSE: To explore the relationship between RRT values and the presence of PVT in cirrhotic participants.

STUDY TYPE: Prospective.

POPULATION: Forty-eight participants with liver cirrhosis (27 males, median age 67 years [IQR: 57-73]) and 20 healthy control participants (12 males, median age 45 years [IQR: 40-54]).

FIELD STRENGTH/SEQUENCE: 3 T/4D Flow MRI.

ASSESSMENT: Laboratory (liver and kidney function test results and platelet count) and clinical data (presence of tumors and other imaging findings), and portal hemodynamics derived from 4D Flow MRI (spatiotemporally averaged RRT [RRT-mean], flow velocity, and flow rate) were analyzed.

STATISTICAL TESTS: We used multivariable logistic regression, adjusted by selected covariates through the Lasso method, to explore whether RRT-mean is an independent risk factor for PVT. The area under the ROC curve (AUC) was also calculated to assess the model’s discriminative ability. P < 0.05 indicated statistical significance.

RESULTS: The liver cirrhosis group consisted of 16 participants with PVT and 32 without PVT. Higher RRT-mean values (odds ratio [OR] 11.4 [95% CI: 2.19, 118]) and lower platelet count (OR 0.98 per 1000 μL [95% CI: 0.96, 0.99]) were independent risk factors for PVT. The incorporation of RRT-mean (AUC, 0.77) alongside platelet count (AUC, 0.75) resulted in an AUC of 0.84. When including healthy control participants, RRT-mean had an adjusted OR of 12.4 and the AUC of the combined model (RRT-mean and platelet count) was 0.90.

DATA CONCLUSION: Prolonged RRT values and low platelet count were significantly associated with the presence of PVT in cirrhotic participants. RRT values derived from 4D Flow MRI may have potential clinical relevance in the management of PVT.

EVIDENCE LEVEL: 2 TECHNICAL EFFICACY: Stage 2.

PMID:38490816 | DOI:10.1002/jmri.29357

Air Med J. 2024 Mar-Apr;43(2):151-156. doi: 10.1016/j.amj.2023.11.009. Epub 2023 Dec 19.

ABSTRACT

OBJECTIVE: The use of traditional inhaled pulmonary vasodilators, such as nitric oxide, to treat symptomatic pulmonary edema is not practical in the air medical or prehospital environment because of difficulty with administration. A hospital-based critical care air medical transport service initiated a pilot study to investigate the use of inhaled nitroglycerin (iNTG) as an alternative pulmonary vasodilator.

METHODS: For this pilot study, iNTG was administered using a jet nebulizer setup and concentrated nitroglycerin, both of which are widely available in acute care settings. In conjunction with medical oversight, transport personnel identified patients with respiratory distress secondary to pulmonary edema. Twenty-two months after initiating the protocol, a retrospective chart review was conducted. Data for patients receiving iNTG were retrospectively abstracted through a medical record search and manual chart review.

RESULTS: Twelve patients received iNTG during the pilot study. Basic demographics, medical comorbidities, concurrent medications, laboratory values, and radiographic studies were collected for each patient. Basic statistics were performed to identify any potential trends.

CONCLUSION: The administration of iNTG is feasible in an air medical transport setting and may provide a useful adjunct to treating patients with pulmonary edema and respiratory distress. Because iNTG delivery targets the pulmonary vasculature, this may be of particular benefit in patients with a poor hemodynamic profile. Larger randomized controlled or cohort studies are needed to specifically analyze and compare hemodynamics, diagnostics, and patient outcomes.

PMID:38490779 | DOI:10.1016/j.amj.2023.11.009

Air Med J. 2024 Mar-Apr;43(2):146-150. doi: 10.1016/j.amj.2023.11.008. Epub 2023 Nov 30.

ABSTRACT

OBJECTIVE: The MIRACLE₂ score has been developed for use in a primary percutaneous coronary intervention center. It is unclear if it is feasible in the helicopter emergency medical service (HEMS) setting.

METHODS: The computerized system at 1 UK HEMS was interrogated between December 1, 2020, and May 1, 2022, for the components of the MIRACLE₂ score (recorded contemporaneously) plus demographics and outcomes in all post-return of spontaneous circulation patients conveyed to the hospital. pH was excluded because of no point-of-care testing resulting in a modified MIRACLE₂ score (maximum score of 9). Data were analyzed using the chi-square test; P < .05 was statistically significant.

RESULTS: Three hundred thirty patients (240 males) with out-of-hospital cardiac arrests were reviewed. Ninety-two adult patients with nontraumatic out-of-hospital cardiac arrests had sustained return of spontaneous circulation and a median MIRACLE₂ score of 4 (range, 0-7). Forty-seven patients died before hospital discharge; the median MIRACLE₂ score was higher in those who died (4) than those who survived (1.5, P < .01); 90.3% of those with a score ≥ 5 were triaged to an emergency department rather than directly to a catheterization laboratory.

CONCLUSION: A modified MIRACLE₂ score can be calculated in the HEMS setting. The benefit of point-of-care testing pH requires investigation. There may be a benefit in predicting outcomes in this nondifferentiated group, but additional research is required.

PMID:38490778 | DOI:10.1016/j.amj.2023.11.008