Category: Statistics

J Trauma Acute Care Surg. 2022 Jan 25. doi: 10.1097/TA.0000000000003551. Online ahead of print.

ABSTRACT

INTRODUCTION: Low titer group O whole blood (LTOWB) resuscitation is increasingly common in both military and civilian settings. Data regarding the safety and efficacy of prehospital LTOWB remains limited.

METHODS: We performed a single center, prospective, cluster randomized, prehospital thru in-hospital whole blood pilot trial for injured air medical patients. We compared standard prehospital air medical care including red cell transfusion and crystalloids followed by in-hospital component transfusion to prehospital and in-hospital LTOWB resuscitation. Prehospital vital signs were used as inclusion criteria (SBP ≤ 90 mmHg and HR ≥ 108 bpm) or (SBP ≤ 70 mmHg) for patients at risk of hemorrhage. Primary outcome was feasibility. Secondary outcomes included 28-day and 24 hour mortality, multiple organ failure, nosocomial infection, 24 hr transfusion requirements and arrival coagulation parameters.

RESULTS: Between November 2018 thru October 2020, 86 injured patients were cluster randomized by helicopter base. The trial has halted early at 77% enrollment. Overall, 28-day mortality for the cohort was 26%. Injured patients randomized to prehospital LTOWB (n = 40) relative to standard care (n = 46) were similar in demographics and injury characteristics. Intent to treat Kaplan-Meier survival analysis demonstrated no statistical mortality benefit at 28 days (25.0% vs. 26.1%, p = 0.85). Patients randomized to prehospital LTOWB relative to standard care had lower red cell transfusion requirements at 24 hours (p < 0.01) and a lower incidence of abnormal thromboelastographic measurements. No transfusion reactions during the prehospital or in-hospital phase of care were documented.

CONCLUSION: Prehospital through in-hospital LTOWB resuscitation is safe and may be associated with hemostatic benefits. A large-scale clinical trial is feasible with protocol adjustment and would allow the effects of prehospital LTOWB on survival and other pertinent clinical outcomes to be appropriately characterized.

LEVEL OF EVIDENCE: II, Cluster randomized pilot trial.

PMID:35081595 | DOI:10.1097/TA.0000000000003551

Ann Surg. 2022 Jan 25. doi: 10.1097/SLA.0000000000005395. Online ahead of print.

ABSTRACT

OBJECTIVE: This study investigates the use of serum DUPAN-2 in predicting the PC progression in CA19-9 nonsecretors.

BACKGROUND: Although we previously reported that serum CA19-9 >500 U/mL is a poor prognostic factor and an indication for enhanced neoadjuvant treatment, there is not a biomarker surrogate that equivalently predicts prognosis for CA19-9 nonsecretors.

METHODS: We evaluated consecutive PC patients who underwent pancreatectomy from 2005 to 2019. All patients were categorized as either nonsecretor or secretor (CA19-9 ≤ or >2.0 U/mL).

RESULTS: Of the 984 resected PC patients, 94 (9.6%) were nonsecretors and 890 (90.4%) were secretors. The baseline characteristics were not statistically different between the 2 groups except for the level of DUPAN-2 (720 vs. 100 U/mL, P < 0.001). Survival curves after resection were similar between the 2 groups (29.4 months vs. 31.3 months, P = 0.900). Survival curves of patients with DUPAN-2 >2000 U/mL in the nonsecretors and patients with CA19-9 >500 U/mL in the secretors were nearly equivalent as well (hazard ratio 2.08 vs. 1.89). In the multivariate analysis, DUPAN-2 >2000 U/mL (hazard ratio 2.53, P = 0.010) was identified as independent prognostic factor after resection.

CONCLUSION: DUPAN-2 >2000 U/mL in CA19-9 nonsecretors can be an unfavorable factor that corresponds to CA19-9 >500 U/mL in CA19-9 secretors which is an indicator for enhanced neoadjuvant treatment. The current results shed light on the subset of nonsecretors with poor prognosis that were traditionally categorized in a group with a more favorable prognosis group.

PMID:35081567 | DOI:10.1097/SLA.0000000000005395

J Occup Environ Med. 2022 Jan 25. doi: 10.1097/JOM.0000000000002491. Online ahead of print.

ABSTRACT

OBJECTIVE: To examine the risk of diseases among industrial workers with low and fractionated radiation exposures.

METHOD: 372,047 US male shipyard radiation and non-radiation workers were followed for 54 years and compared to US males using Standardized Mortality Ratio (SMR) method.

RESULTS: SMRs for both radiation and non-radiation workers had lower risks of death from all causes (0.74; 95% Confidence interval (CI) 0.74-0.75 and 0.77; 95% Cl 0.77-0.78, respectively) and from all cancers (0.92; 95% CI 0.91-0.93 and 0.90; 95% CI 0.89-0.91, respectively) compared to US males. Asbestos-related diseases including pleural cancers, mesothelioma, and asbestosis, but not lung cancers, were statistically higher in both radiation and non-radiation workers compared to the US males.

CONCLUSION: US shipyard male radiation and non-radiation workers did not show any elevated mortality risks that might be associated with radiation exposure.

PMID:35081587 | DOI:10.1097/JOM.0000000000002491

J Psychiatr Res. 2022 Jan 18;148:1-8. doi: 10.1016/j.jpsychires.2022.01.031. Online ahead of print.

ABSTRACT

Although preliminary neuroimaging research suggests that patients with hoarding disorder (HD) show widespread abnormal task-related activity in the brain, there has been no research on alterations in the white matter tracts in these patients. The aim of this study was to investigate the characteristics of the major white matter tracts in patients with HD. Tract-based spatial statistics were used to search for white matter tract abnormalities throughout the brain in 25 patients with HD and 36 healthy controls. Post hoc analysis of regions of interest was performed to detect correlations with clinical features. Compared with the controls, patients with HD showed decreased fractional anisotropy and increased radial diffusivity in anatomically widespread white matter tracts. Post hoc analysis of regions of interest revealed a significant negative correlation between the severity of hoarding symptoms and fractional anisotropy in the left anterior limb of the internal capsule and a positive correlation between the severity of these symptoms and radial diffusivity in the right anterior thalamic radiation. Patients with HD showed a broad range of alterations in the frontal white matter tracts, including the frontothalamic circuit, frontoparietal network, and frontolimbic pathway. The findings of this study indicate associations between frontal white matter abnormalities related to the severity of hoarding symptoms in HD and the cortical regions involved in cognitive dysfunction. The insights provided would be useful for understanding the neurobiological basis of HD.

PMID:35081485 | DOI:10.1016/j.jpsychires.2022.01.031

Eur J Radiol. 2022 Jan 19;148:110165. doi: 10.1016/j.ejrad.2022.110165. Online ahead of print.

ABSTRACT

PURPOSE: To investigate the value of dual-energy CT imaging to discriminate low- from high- risk type II endoleaks (T2EL) after endovascular aneurysm repair (EVAR).

METHOD: Study participants were consecutive patients referred for CT at 1-month post-EVAR. CT imaging acquisition included a dual-energy CT angiography (DECTA) and a delayed single-energy CT (SECT) imaging. Patients diagnosed with T2EL were re-examined at 6-months post-EVAR to assess the aneurysm sac growth (ASG). Upon ASG recorded, patients were categorized as having low- (group A) or high- risk (group B) T2EL. DECTA image data were employed to calculate the normalized effective atomic number (NZ_eff), the normalized iodine concentration, the slope of HU_endoleak/HU_aorta against monochromatic energy, the dual-energy index and an improvised endoleak index (EI) for each T2EL. Statistical analysis was employed to compare all above parameters regarding their ability to differentiate low- from high- risk T2EL.

RESULTS: Among 40 patients examined at 1-month post-EVAR, 14 patients were diagnosed with T2EL. NZ_eff and EI were found to be significantly lower in group A. NZ_eff was found to have the highest power to discriminate high-risk T2EL with an area-under-curve of 86.7%, showing100% specificity and 60% sensitivity. The optimal contrast-to-noise ratio for T2EL demonstrated a median peak conspicuity level at 54-keV. The mean effective dose from DECTA and SECT scans was 27.8% lower compared to the sum of three SECT acquisitions.

CONCLUSIONS: NZ_eff and EI were found to have a significant power in predicting the aggressiveness of T2EL lesions. Virtual monochromatic images at 54-keV may enhance T2EL detection efficiency.

PMID:35081491 | DOI:10.1016/j.ejrad.2022.110165

J Neurol Sci. 2022 Jan 6;434:120142. doi: 10.1016/j.jns.2022.120142. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the impact of desmopressin acetate (DDAVP) on poor outcomes, hematoma expansion, and adverse events in patients diagnosed with a non-traumatic, antiplatelet-associated intracranial hemorrhage (ICH).

METHODS: This was a multicenter, retrospective, propensity-matched cohort study comparing DDAVP to control in patients diagnosed with a non-traumatic ICH previously on antiplatelet therapy. Notable exclusion criteria included admission to trauma service, subarachnoid hemorrhages, confounding coagulopathic factors, and hematoma evacuation. Poor outcome, defined as discharge to hospice or in-patient mortality, was the primary outcome. Secondary outcomes included intracranial hematoma expansion and occurrence of adverse events, which included hyponatremia and thromboembolic events.

RESULTS: A total of 49 patients receiving DDAVP were compared to 107 controls in the unmatched cohort. Thirty-seven patients treated with DDAVP and 55 controls were included in the propensity-matched analysis, which was adjusted for age, ethnicity, history of diabetes, receipt of platelet transfusion, and thromboembolism prophylaxis. Poor outcome (16.2% DDAVP vs 29% control, p = 0.13), rates of hematoma expansion (11.8% DDAVP vs 11.1% control, p = 0.99), and adverse events (21.6% DDAVP vs 20% control, p = 0.99) were statistically similar between the matched groups.

CONCLUSIONS: DDAVP administration in patients with spontaneous antiplatelet-associated ICH was not associated with a reduction in poor outcomes, hematoma expansion, or an increase in adverse events. Use of DDAVP in this patient population appears to be safe. Larger prospective studies are warranted to evaluate DDAVP utility in this patient population.

PMID:35081458 | DOI:10.1016/j.jns.2022.120142

J Pain Symptom Manage. 2022 Jan 23:S0885-3924(22)00034-3. doi: 10.1016/j.jpainsymman.2022.01.013. Online ahead of print.

ABSTRACT

CONTEXT: The optimal strategy for implementing mortality-predicting algorithms to facilitate clinical care, prognostic discussions, and palliative care interventions remains unknown.

OBJECTIVES: To develop and validate a real-time predictive model for 180-day mortality using routinely available clinical and laboratory admission data and determine if palliative care exposure varies with predicted mortality risk.

METHODS: Adult admissions between 10/1/2013 and 10/1/2017 were included for the model derivation. A separate cohort was collected between 1/1/2018 and 7/31/2020 for validation. Patients were followed for 180 days from discharge, and logistic regression with selected variables was used to estimate patients’ risk for mortality.

RESULTS: In the model derivation cohort, 7963 events of 180-day mortality (4.5% event rate) were observed. Median age was 53.0 (IQR 24.0-66.0) with 92,734 females (52.5%). Variables with strongest association with 180-day mortality included: Braden Score (OR 0.83; 95% CI 0.82-0.84); admission Do Not Resuscitate orders (OR 2.61; 95% CI 2.43-2.79); admission service and admission status. The model yielded excellent discriminatory ability in both the derivation (c-statistic 0.873; 95% CI 0.870-0.877; Brier score 0.04) and validation cohorts (c-statistic 0.844; 95% CI 0.840-0.847; Brier score 0.072). Inpatient palliative care consultations increased from 3% of minimal-risk encounters to 41% of high-risk encounters (p<0.01).

CONCLUSION: We developed and temporally validated a predictive mortality model for adults from a large retrospective cohort, which helps quantify the potential need for palliative care referrals based on risk strata. Machine learning algorithms for mortality require clinical interpretation, and additional studies are needed to design patient-centered and risk-specific interventions.

PMID:35081441 | DOI:10.1016/j.jpainsymman.2022.01.013

J Clin Epidemiol. 2022 Jan 23:S0895-4356(22)00021-X. doi: 10.1016/j.jclinepi.2022.01.014. Online ahead of print.

ABSTRACT

OBJECTIVES: To determine the prevalence of poor interpretation practices, such as conflating evidence of absence with absence of evidence and over-emphasis of statistical non-significance in abstract conclusions, in a sample of randomised controlled trials (RCTs) with non-statistically significant primary outcomes published after the 2016 American Statistical Association statement on the interpretation of p-values.

DESIGN AND SETTING: Review of 50 two-arm individually randomised superiority trials with non-statistically significant results in four high impact journals published between 2017 and 2020, to determine the proportion that conclude evidence of no impact (thus, likely conflating evidence of absence with absence of evidence) or place emphasis on statistical non-significance (technically correct but arguably uninformative) in the abstract conclusion.

RESULTS: Of the 50 RCTs with non-statistically significant results for primary outcomes, 28 (56%) of abstract were classified as concluding there was no difference between the two treatments; 19 (38%) placed an over-emphasis on statistical significance; only one acknowledged any uncertainty and the remaining 2 (4%) concluded that one treatment was more effective. Only four studies provided any justification for a finding of no difference, for example that the confidence interval gave no support to values of importance.

CONCLUSIONS: RCTs with non-statistically significant primary outcomes almost always present their conclusion in the abstract as evidence of no impact or ambiguously as “not statistically significant” without giving due attention to values supported by the confidence interval.

PMID:35081450 | DOI:10.1016/j.jclinepi.2022.01.014

Urology. 2022 Jan 23:S0090-4295(22)00070-X. doi: 10.1016/j.urology.2022.01.020. Online ahead of print.

ABSTRACT

OBJECTIVE: To examine practice-level variation in the management of MRI PI-RADS 3 lesions in men with favorable-risk prostate cancer (FRPC) considering or on active surveillance (AS).

METHODS: We reviewed the MUSIC registry for FRPC men (GG1 and low-volume GG2) undergoing MRI from 1/2013-3/2020. The primary outcome was to assess practice-level variation in time from MRI to biopsy and MRI to treatment for PI-RADS 3 lesions. Both MRIs obtained after the diagnostic biopsy and while on AS were included. The Kaplan-Meier method was used to estimate biopsy-free survival for time from MRI to surveillance biopsy and multivariable Cox proportional hazards models identified clinical and demographic factors associated with time obtaining a biopsy after finding PI-RADS 3 lesions.

RESULTS: We identified 3,172 FRPC men with a MRI, of whom 473 had a PI-RADS 3. There was significant practice-level variation in biopsy rates among patients with PI-RADS 3 MRI results (log-rank test, p<0.001), with biopsy-free probability at 6 months ranging from 28%-69% (median: 59%). We were unable to identify factors with significant associations with time to biopsy. Conversely, there was less variation in time from PI-RADS 3 to treatment (log-rank test, p=0.2), while several clinical factors had statistically-significant associations: age(p=0.018), PSA-Density 0.1-0.2(p=0.035), ISUP-GG 2(p=0.002), and number of positive cores(p<0.001), as expected.

CONCLUSION: Urology practice, rather than GG or extent of biopsy positivity, is the largest factor affecting the decision for biopsy of PI-RADS 3 lesions in FRPC men considering or on AS. Future work to assist with decision-making and reduce variability is needed.

PMID:35081398 | DOI:10.1016/j.urology.2022.01.020

J Dent. 2022 Jan 23:104050. doi: 10.1016/j.jdent.2022.104050. Online ahead of print.

ABSTRACT

OBJECTIVES: To assess the performance of a novel resin-modified glass-ionomer cement (pRMGIC) bonded to various tooth tissues after two-time intervals.

METHODS: 192 sound human molars were randomly assigned to 3 groups (n=64): sound enamel, demineralised enamel, sound dentine. Sixty-four teeth with natural carious lesions including caries-affected dentine (CAD) were selected. All substrates were prepared, conditioned and restored with pRMGIC (30% ethylene glycol methacrylate phosphate (EGMP, experimental), Fuji II LC (control), Fuji IX, and Filtek™ Supreme with Scotchbond ^TM Universal Adhesive. Shear bond strength (SBS) was determined after 24 h and three months storage in SBF at 37°C. The debonded surfaces were examined using stereomicroscopy and scanning electron microscopy (SEM). Multivariate Analysis of Variance (MANOVA), Bonferroni post hoc tests (alpha=0.05) and independent T-tests were used for multifactorial data analysis.

RESULTS: The hydrophilicity and functionality of EGMP enhanced the bond strength of the pRMGIC to different substrates after 24 h and 3 months as compared to F2LC (p<0.05). Adhesive failures were found to decrease with pRMGIC and integration into exposed enamel prisms and dentine tubules was observed with SEM. Ageing enhanced bond strength of pRMGIC to all substrates but was statistically significantly only in sound dentine. The SBS of pRMGIC was higher with sound vs. demineralised enamel at both time periods (p<0.001), while it was higher to CAD initially and to sound dentine post-storage (p=0.004).

CONCLUSIONS: pRMGIC exhibited enhanced bonding performance to various tooth tissues with an ability to seal exposed enamel prisms and dentine tubules.

CLINICAL SIGNIFICANCE: pRMGIC is a promising material exhibiting long-lasting bonded-tooth interfaces, for its use in minimally invasive reparative techniques.

PMID:35081422 | DOI:10.1016/j.jdent.2022.104050