A multi-center study to predict the risk of intraoperative hypothermia in gynecological surgery patients using preoperative variables.

OBJECTIVES: Hypothermia is highly common in patients undergoing gynecological surgeries under general anesthesia, so the length of hospitalization and even the risk of mortality are substantially increased. Our aim was to develop a simple and practical model to preoperatively identify gynecological surgery patients at risk of intraoperative hypothermia. METHODS: In this retrospective study, we collected data from 802 patients who underwent gynecological surgery at three medical centers from June 2022 to August 2023. We further allocated the patients to a training group, an internal validation group, or an external validation group. The preliminary predictive factors for intraoperative hypothermia in gynecological patients were determined using the least absolute shrinkage and selection operator (LASSO) method. The final predictive factors were subsequently identified through multivariate logistic regression analysis, and a nomogram for predicting the occurrence of hypothermia was established. RESULTS: A total of 802 patients were included, with 314 patients in the training cohort (mean age 48.5 ± 12.6 years), 130 patients in the internal validation cohort (mean age 49.9 ± 12.5 years), and 358 patients in the external validation cohort (mean age 47.6 ± 14.0 years). LASSO regression and multivariate logistic regression analyses indicated that body mass index, minimally invasive surgery, baseline heart rate, baseline body temperature, history of previous surgery, and aspartate aminotransferase level were associated with intraoperative hypothermia in gynecological surgery patients. This nomogram was constructed based on these six variables, with a C-index of 0.712 for the training cohort. CONCLUSIONS: We established a practical predictive model that can be used to preoperatively predict the occurrence of hypothermia in gynecological surgery patients. CLINICAL TRIAL REGISTRATION: chictr.org.cn, identifier ChiCTR2300071859.

Long-term Outcomes of Endovascular Repair for Blunt Thoracic Aortic Injury: A 10 Year Multi-center Experience.

OBJECTIVE: This study aimed to assess the long-term outcomes in patients treated by thoracic endovascular aortic repair (TEVAR) for blunt thoracic aortic injuries (BTAI). MATERIALS AND METHODS: From January 2010 to December 2019, this retrospective observational study was conducted at 3 centers, involving 62 consecutive BTAI patients who underwent TEVAR. Computed tomography angiography scans were planned to be conducted at 6 months post-procedure, and annually thereafter. RESULTS: Technical success was achieved in all 62 procedures (100%), which included cases of dissection (n=35, 56.45%), pseudoaneurysm (n=20, 32.26%), and rupture (n=7, 11.29%). Mean injury severity score was 31.66±8.30. A total of 21 supra-arch branches were revascularized by chimney technique, with 12 cases involving the left subclavian artery (LSA) and 9 cases involving the left common carotid artery. In addition, 11 LSAs were covered during the procedure. The in-hospital mortality rate was 1.61% (n=1). The mean follow-up time was 86.82±30.58 months. The all-cause follow-up mortality rate was 3.28% (n=2). Stenosis or occlusion of 3 supra-arch branches (4.92%) was identified at follow-up, with 2 cases (3.28%) requiring re-intervention. No spinal cord ischemia, endoleak, or migration was observed. CONCLUSIONS: Despite only including patients with long-term follow-up, this study confirms the long-term safety and effectiveness of TEVAR for BTAI. For young BTAI patients, as the thoracic aorta increases with age, longer follow-up is needed to observe the potential mismatch between the endograft and the aorta. CLINICAL IMPACT: This study confirms the long-term safety and effectiveness of endovascular treatment for blunt thoracic aortic injury (BTAI). For young BTAI patients, as the thoracic aorta increases with age, longer follow-up is needed to observe the potential mismatch between the endograft and the aorta. Through a remarkably extended follow-up period (86.82±30.58 months) conducted at multiple centers in China, this study confirms the long-term safety and effectiveness of endovascular treatment for BTAI.

Causes of death and treatment-related mortality in newly diagnosed childhood acute lymphoblastic leukemia treatment with Chinese Children's Cancer Group study ALL-2015.

To investigate the possible risk factors for death at post-treatment in children with acute lymphoblastic leukemia (ALL). A multivariate competing risk analysis was performed to retrospectively analyze the data of children with ALL who died after treatment with CCCG-ALL-2015 in China and to determine the possible risk factors for death at post-treatment in children with ALL. Age at the first diagnosis of ≥10 years; final risk level of high-risk; D19 minimal residual disease (MRD) (≥0.01%) and D46 MRD (≥0.01%); genetic abnormalities, such as KMT2A-rearrangement, c-Myc rearrangement, and PDGFRB rearrangement; and the presence of CNS3 (all P values, <0.05) were identified as independent risk factors, whereas the risk level at the first diagnosis of low-risk (LR) and ETV6::RUNX1 positivity was considered as independent protective factors of death in children with ALL. Among the 471 cases of death, 45 cases were treated with CCCG-ALL-2015 only, and 163 (34.61%) were treatment-related, with 62.42% due to severe infections. 55.83% of treatment-related mortality (TRM) occurred in the early phase of treatment (induction phase). TRM has a significant impact on the overall survival of pediatric patients with ALL. Moreover, the CCCG-ALL-2015 regimen has a better safety profile for treating children with ALL, with rates close to those in developed countries (registration number: ChiCTR-IPR-14005706; date of registration: June 4, 2014).

A novel prognostic model based on pretreatment serum albumin and ECOG PS for primary CNS lymphoma: an international, multi-center study.

BACKGROUND: Serum albumin has been demonstrated as prognostic parameter in non-Hodgkin lymphoma (NHL). Primary central nervous system lymphoma (PCNSL) is a rare extranodal NHL with highly aggressive behavior. In this study, we aimed at creating a novel prognostic model for PCNSL based on serum albumin levels. METHODS: We compared several commonly used laboratory nutritional parameters for predicting the survival of PCNSL patients using overall survival (OS) for outcome analysis and receiver operating characteristic curve analysis to determine the optimal cut-off values. Parameters associated with OS were evaluated by univariate and multivariate analyses. Independent prognostic parameters for OS were selected for risk stratification, including albumin ≤ 4.1 g/dL, ECOG PS > 1, and LLR > 166.8, which were associated with shorter OS; albumin > 4.1 g/dL, ECOG PS 0-1 and LLR ≤ 166.8, which were associated with longer OS, and five-fold cross-validation was used for evaluating predictive accuracy of identified prognostic model. RESULTS: By univariate analysis, age, ECOG PS, MSKCC score, Lactate dehydrogenase-to-lymphocyte ratio (LLR), total protein, albumin, hemoglobin, and albumin to globulin ratio (AGR) resulted statistically associated with the OS of PCNSL. By multivariate analysis, albumin ≤ 4.1 g/dL, ECOG PS > 1, and LLR > 166.8 were confirmed to be significant predictors of inferior OS. We explored several PCNSL prognostic models based on albumin, ECOG PS and LLR with 1 point assigned to each parameter. Eventually, a novel and effective PCNSL prognostic model based on albumin and ECOG PS successfully classified patients into three risk groups with 5-year survival rates of 47.5%, 36.9%, and 11.9%, respectively. CONCLUSIONS: The novel two-factor prognostic model based on albumin and ECOG PS we propose represents a simple but significant prognostic tool for assessing newly diagnosed patients with PCNSL.

A snapshot of pediatric inpatients and outpatients with COVID-19: a point prevalence study from Turkey.

This multi-center point prevalence study evaluated children who were diagnosed as having coronavirus disease 2019 (COVID-19). On February 2nd, 2022, inpatients and outpatients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were included in the study from 12 cities and 24 centers in Turkey. Of 8605 patients on February 2nd, 2022, in participating centers, 706 (8.2%) had COVID-19. The median age of the 706 patients was 92.50 months, 53.4% were female, and 76.7% were inpatients. The three most common symptoms of the patients with COVID-19 were fever (56.6%), cough (41.3%), and fatigue (27.5%). The three most common underlying chronic diseases (UCDs) were asthma (3.4%), neurologic disorders (3.3%), and obesity (2.6%). The SARS-CoV-2-related pneumoniae rate was 10.7%. The COVID-19 vaccination rate was 12.5% in all patients. Among patients aged over 12 years with access to the vaccine given by the Republic of Turkey Ministry of Health, the vaccination rate was 38.7%. Patients with UCDs presented with dyspnea and pneumoniae more frequently than those without UCDs (p < 0.001 for both). The rates of fever, diarrhea, and pneumoniae were higher in patients without COVID-19 vaccinations (p = 0.001, p = 0.012, and p = 0.027).  Conclusion: To lessen the effects of the disease, all eligible children should receive the COVID-19 vaccine. The illness may specifically endanger children with UCDs. What is Known: • Children with COVID-19 mainly present with fever and cough, as in adults. • COVID-19 may specifically threaten children with underlying chronic diseases. What is New: • Children with obesity have a higher vaccination rate against COVID-19 than children without obesity. • Among unvaccinated children, fever and pneumoniae might be seen at a higher ratio than among vaccinated children.

Integrated partially linear model for multi-center studies with heterogeneity and batch effect in covariates.

The design of multi-center study is increasingly used for borrowing strength from multiple research groups to obtain broadly applicable and reproducible study findings. Regression analysis is widely used for analyzing multi-group studies, however, some of the large number of regression predictors are nonlinear and/or often measured with batch effects in many large scale collaborative studies. Also, the group compositions of the nonlinear predictors are potentially heterogeneous across different centers. The conventional pooled data analysis ignores the interplay between nonlinearity and batch effect, group composition heterogeneity, measurement error and other data incoherence in multi-center setting that can cause biased regression estimates and misleading outcomes. In this paper, we propose an integrated partially linear regression model (IPLM) based analysis to account for the predictor's nonlinearity, general batch effect, group composition heterogeneity, high-dimensional covariates, potential measurement-error in covariates, and combinations of these complexities simultaneously. A local linear regression based approach is employed to estimate the nonlinear component and a regularization procedure is introduced to identify the predictors' effects that can be either homogeneous or heterogeneous across groups. In particular, when the effects of all predictors are homogeneous across the study centers, the proposed IPLM can automatically reduce to one single parsimonious partially linear model for all centers. The proposed method has asymptotic estimation and variable selection consistency including high-dimensional covariates. Moreover, it has a fast computing algorithm and its effectiveness is supported by numerical simulation studies. A multi-center Alzheimer's disease research project is provided to illustrate the proposed IPLM based analysis.

Reliability of multi-parameter mapping (MPM) in the cervical cord: A multi-center multi-vendor quantitative MRI study.

MRI based multicenter studies which target neurological pathologies affecting the spinal cord and brain - including spinal cord injury (SCI) - require standardized acquisition protocols and image processing methods. We have optimized and applied a multi-parameter mapping (MPM) protocol that simultaneously covers the brain and the cervical cord within a traveling heads study across six clinical centers (Leutritz et al., 2020). The MPM protocol includes quantitative maps (magnetization transfer saturation (MT), proton density (PD), longitudinal (R1), and effective transverse (R2*) relaxation rates) sensitive to myelination, water content, iron concentration, and morphometric measures, such as cross-sectional cord area. Previously, we assessed the repeatability and reproducibility of the brain MPM data acquired in the five healthy participants who underwent two scan-rescans (Leutritz et al., 2020). This study focuses on the cervical cord MPM data derived from the same acquisitions to determine its repeatability and reproducibility in the cervical cord. MPM matrices of the cervical cord were generated and processed using the hMRI and the spinal cord toolbox. To determine reliability of the cervical MPM data, the intra-site (i.e., scan-rescan) coefficient of variation (CoV), inter-site CoV, and bias within region of interests (C1, C2 and C3 levels) were determined. The range of the mean intra- and inter-site CoV of MT, R1 and PD was between 2.5% and 12%, and between 1.1% and 4.0% for the morphometric measures. In conclusion, the cervical MPM data showed a high repeatability and reproducibility for key imaging biomarkers and hence can be employed as a standardized tool in multi-center studies, including clinical trials.

A deep learning masked segmentation alternative to manual segmentation in biparametric MRI prostate cancer radiomics.

OBJECTIVES: To determine the value of a deep learning masked (DLM) auto-fixed volume of interest (VOI) segmentation method as an alternative to manual segmentation for radiomics-based diagnosis of clinically significant (CS) prostate cancer (PCa) on biparametric magnetic resonance imaging (bpMRI). MATERIALS AND METHODS: This study included a retrospective multi-center dataset of 524 PCa lesions (of which 204 are CS PCa) on bpMRI. All lesions were both semi-automatically segmented with a DLM auto-fixed VOI method (averaging < 10 s per lesion) and manually segmented by an expert uroradiologist (averaging 5 min per lesion). The DLM auto-fixed VOI method uses a spherical VOI (with its center at the location of the lowest apparent diffusion coefficient of the prostate lesion as indicated with a single mouse click) from which non-prostate voxels are removed using a deep learning-based prostate segmentation algorithm. Thirteen different DLM auto-fixed VOI diameters (ranging from 6 to 30 mm) were explored. Extracted radiomics data were split into training and test sets (4:1 ratio). Performance was assessed with receiver operating characteristic (ROC) analysis. RESULTS: In the test set, the area under the ROC curve (AUCs) of the DLM auto-fixed VOI method with a VOI diameter of 18 mm (0.76 [95% CI: 0.66-0.85]) was significantly higher (p = 0.0198) than that of the manual segmentation method (0.62 [95% CI: 0.52-0.73]). CONCLUSIONS: A DLM auto-fixed VOI segmentation can provide a potentially more accurate radiomics diagnosis of CS PCa than expert manual segmentation while also reducing expert time investment by more than 97%. KEY POINTS: • Compared to traditional expert-based segmentation, a deep learning mask (DLM) auto-fixed VOI placement is more accurate at detecting CS PCa. • Compared to traditional expert-based segmentation, a DLM auto-fixed VOI placement is faster and can result in a 97% time reduction. • Applying deep learning to an auto-fixed VOI radiomics approach can be valuable.

Performance comparison of two nucleic acid amplification systems for SARS-CoV-2 detection: A multi-center study.

BACKGROUND: Many rapid nucleic acid testing systems have emerged to halt the development and spread of COVID-19. However, so far relatively few studies have compared the diagnostic performance between these testing systems and conventional detection systems. Here, we performed a retrospective analysis to evaluate the clinical detection performance between SARS-CoV-2 rapid and conventional nucleic acid detection system. METHODS: Clinical detection results of 63,352 oropharyngeal swabs by both systems were finally enrolled in this analysis. Sensitivity (SE), specificity (SP), and positive and negative predictive value (PPV, NPV) of both systems were calculated to evaluate their diagnostic accuracy. Concordance between these two systems were assessed by overall, positive, negative percent agreement (OPA, PPA, NPA) and κ value. Sensitivity of SARS-CoV-2 rapid nucleic acid detection system (Daan Gene) was further analyzed with respect to the viral load of clinical specimens. RESULTS: Sensitivity of Daan Gene was slightly lower than that of conventional detection system (0.86 vs. 0.979), but their specificity was equivalent. Daan Gene had ≥98.0% PPV and NPV for SARS-CoV-2. Moreover, Daan Gene demonstrated an excellent test agreement with conventional detection system (κ = 0.893, p = 0.000). Daan Gene was 99.31% sensitivity for specimens with high viral load (Ct < 35) and 50% for low viral load (Ct ≥ 35). CONCLUSIONS: While showing an analytical sensitivity slightly below than that of conventional detection system, rapid nucleic acid detection system may be a diagnostic alternative to rapidly identify SARS-CoV-2-infected individuals with high viral loads and a powerful complement to current detection methods.

Physicians' knowledge, attitude, and prescribing behavior regarding stress ulcer prophylaxis in China: a multi-center study.

BACKGROUND: Perioperative patients are at risk of developing stress ulcers (SU), which can cause clinically important bleeding. Stress ulcer prophylaxis (SUP) is widely applied to the patients in Intensive care unit (ICU) as well as the general ward, so it may lead to overmedication. However, there have been no surveys regarding SUP knowledge or prescribing habits. OBJECTIVE: Our study assessed the knowledge, attitudes, and prescribing behavior of the surgeons toward perioperative patients regarding SUP and determined factors associated with low knowledge and high level of prescribing behaviors. METHODS: We performed a cross-sectional survey using questionnaires, randomly sampling 1266 surgeons on their current SUP practices. RESULTS: Proton pump inhibitors for SUP were used the most (94%); 43% used lansoprazole. Guideline awareness was inconsistent; the most familiar guideline was the National Medical Journal of China, and 46% were unaware of any guidelines. The predictors of low knowledge score regarding SUP in multivariable analysis were the hospital grade (p = 0.000), the type of hospital (p = 0.044), attendance at continuing education programs (p = 0.037), the awareness of clinical practice guidelines (CPGs) for SUP (p = 0.000). Twenty-one percent of physicians were high prescribers. High prescribing behavior was associated with hospital grade(p = 0.000), education level(p = 0.010) and attendance at continuing education programs (p = 0.000). CONCLUSION: We found that most surgeons used SUP, primarily proton pump inhibitors. However, surgeons knew little about the SUP guidelines, which may lead to insufficient SUP knowledge and overmedication. In addition, hospital grade, the type of hospital and attendance at continuing education programs may also affect the low knowledge of SUP. Hospital grade, education level and attendance at continuing education programs may affect high prescribing behavior.

A multi-center psychometric evaluation of the Severity Indices of Personality Problems 118 (SIPP-118): Do we really need all those facets?

PURPOSE: The Severity Indices of Personality Problems 118 (SIPP-118) is a self-report questionnaire that aims to measure core components of (mal)adaptive personality functioning that can change over time. In this study, we aimed to assess the facet strength of the 16 facets across three large clinical samples. METHODS: Data from Norwegian and Dutch psychiatric patients were analyzed in this international multi-center study (N1 = 2814, N2 = 4751, N3 = 2217). Bi-factor modeling was used to assess to what degree the SIPP items tap into an overall general factor. The incremental value (distinctiveness) of the facets was studied using proportional reduction in mean squared error (PRMSE) based statistics. RESULTS: The estimated model showed adequate fit. The explained common variance (ECV) attributable to the general factor equaled 50% for all three samples. All but two facets (stable self-image and frustration tolerance) showed sufficient levels of distinctiveness. The findings were observed to be comparable across the three samples. CONCLUSION: Our findings showed that the general factor was relatively weak, and the facets had a clear incremental value.

Implementation, efficacy, costs and processes of inpatient equivalent home-treatment in German mental health care (AKtiV): protocol of a mixed-method, participatory, quasi-experimental trial.

BACKGROUND: Over the last decades, many high-income countries have successfully implemented assertive outreach mental health services for acute care. Despite evidence that these services entail several benefits for service users, Germany has lagged behind and has been slow in implementing outreach services. In 2018, a new law enabled national mental health care providers to implement team-based crisis intervention services on a regular basis, allowing for different forms of Inpatient Equivalent Home Treatment (IEHT). IEHT is similar to the internationally known Home Treatment or Crisis Resolution Teams. It provides acute psychiatric treatment at the user's home, similar to inpatient hospital treatment in terms of content, flexibility, and complexity. METHODS/DESIGN: The presented naturalistic, quasi-experimental cohort study will evaluate IEHT in ten hospitals running IEHT services in different German regions. Within a multi-method research approach, it will evaluate stakeholders' experiences of care, service use, efficacy, costs, treatment processes and implementation processes of IEHT from different perspectives. Quantitative surveys will be used to recruit 360 service users. Subsequently, 180 service users receiving IEHT will be compared with 180 matched statistical 'twins' receiving standard inpatient treatment. Assessments will take place at baseline as well as after 6 and 12 months. The primary outcome is the hospital re-admission rate within 12 months. Secondary outcomes include the combined readmission rate, total number of inpatient hospital days, treatment discontinuation rate, quality of life, psycho-social functioning, job integration, recovery, satisfaction with care, shared decision-making, and treatment costs. Additionally, the study will assess the burden of care and satisfaction with care among relatives or informal caregivers. A collaborative research team made up of researchers with and without lived experience of mental distress will conduct qualitative investigations with service users, caregivers and IEHT staff teams to explore critical ingredients and interactions between implementation processes, treatment processes, and outcomes from a stakeholder perspective. DISCUSSION: By integrating outcome, process and implementation research as well as different stakeholder perspectives and experiences in one study, this trial captures the various facets of IEHT as a special form of home treatment. Therefore, it allows for an adequate, comprehensive evaluation on different levels of this complex intervention. TRIAL REGISTRATION: Trial registrations: 1) German Clinical Trials Register (DRKS), DRKS000224769. Registered December 3rd 2020, https://www.drks.de/drks_web/setLocale_EN.do ; 2) ClinicalTrials.gov, Identifier: NCT0474550 . Registered February 9th 2021.

Normal reference intervals of prognostic nutritional index in healthy adults: A large multi-center observational study from Western China.

BACKGROUND: It has been widely reported that the prognostic nutritional index (PNI) played a pivotal role in nutritional assessment of surgical patients and tumor prognosis. In order to improve the accuracy of evaluation in Western China, we established reference intervals (RIs) of PNI in healthy controls. METHODS: A retrospective cohort study on healthy ethnic Han adults (18-79 years) was conducted to explore the influences of age, gender, study centers, and instruments on PNI and to establish RIs. The data came from a healthy routine examination center database and laboratory information system (LIS) of four centers in Western China, and there were 200 persons selected randomly for verification of RIs. RESULTS: Five thousand eight hundred and thirty-nine healthy candidates were enrolled. PNI showed a marked gender dependence, and males had significantly higher PNI than females across all ages (p < 0.01). We found that PNI is significantly different between age groups (p < 0.01), the value of PNI tended to decrease with age increasing. There is also an obvious influence of centers and instruments on PNI (p < 0.01). CONCLUSIONS: We established reference intervals of PNI in healthy Han Chinese population in Western China and validated successfully. Further established RIs will lead to better standardizations of PNI for clinical applications.

The clinical application of PIVKA-II in hepatocellular carcinoma and chronic liver diseases: A multi-center study in China.

BACKGROUND: Due to the absence of specific symptoms and low survival rate, efficient biomarkers for hepatocellular carcinoma (HCC) diagnosis are urgently required. The purpose of this study was to evaluate the diagnostic performance of protein induced by vitamin K absence or antagonist-II (PIVKA-II) and to determine the optimal cutoff values for HBV infection-related HCC. METHODS: We conducted a cross-sectional, multi-center study in China to ascertain the cutoff value for HCC patients in the context of CHB- and HBV-related cirrhosis. The receiver operating characteristic curve (ROC) and the area under the curve (AUC) were used to evaluate the diagnostic performance of PIVKA-II. RESULTS: This study enrolled 784 subjects and demonstrated that PIVKA-II had a sensitivity of 84.08% and a specificity of 90.43% in diagnosis HCC from chronic liver diseases. PIVKA-II at a cutoff of 37.5 mAU/mL yielded an AUC of 0.9737 (sensitivity 91.78% and specificity 96.30%) in discriminating HCC from chronic hepatitis B (CHB) patients. PIVKA-II at a cutoff of 45 mAU/mL yielded an AUC of 0.9419 (sensitivity 77.46% and specificity 95.12%) in discriminating HCC- from HBV-related cirrhosis patients. Furthermore, using a cutoff value of 40 mAU/mL for PIVKA-II as an HCC marker, only 4.81% (15/312) was positive in chronic hepatitis and 12.80% (37/289) in cirrhosis patients, revealing the satisfactory specificity of PIVKA-II in chronic liver disease of different etiologies. CONCLUSION: Our data indicated that PIVKA-II had satisfactory diagnostic efficiencies and could be used as a screening or surveillance biomarker in HCC high-risk population.

Surveillance of antimicrobial susceptibilities reveals high proportions of multidrug resistance in toxigenic Clostridium difficile strains in different areas of Poland.

Two hundred and fifty-three non-duplicate toxigenic Clostridium difficile isolates, collected from February 2012 to December 2014, were evaluated for phenotypic resistance to ten antimicrobial drugs with the E-test gradient diffusion method. All strains of C. difficile were susceptible to metronidazole, vancomycin, and tigecycline. The metronidazole MIC values of the hyperepidemic PCR-ribotypes RT027 and RT176 were higher than those of non-epidemic PCR-ribotypes (p < 0.05, as evidenced by Mann-Whitney U test). In contrast, vancomycin susceptibility did not differ between hyperepidemic and non-epidemic strains, although the difference was almost significant (p = 0.065). Clostridium difficile RT027 and RT176 isolates could be assessed to five and four different susceptibility patterns, respectively, representing various combinations of resistance to different antimicrobial classes. A single point mutation (Thr82Ile) in the gyrA gene was detected in 11 (78.6%) of 14 isolates with high level of resistance to ciprofloxacin and moxifloxacin and four different types of single point mutations (Arg447Lys, Ser416Ala, Asp426Val, Asp426Asn) in the gyrB gene were detected in 4 strains, also with high level of resistance to ciprofloxacin and moxifloxacin. Four different point mutations were detected in the rpoB gene in 21 rifampicin-resistant strains of which one has not been reported previously, Gln489Leu. This study demonstrates the presence of multidrug-resistant C. difficile strains in Polish hospitals over the study period, irrespective of geographical location or reference level of the hospital.

Patients with head and neck cancer may need more intensive pain management to maintain daily functioning: a multi-center study.

PURPOSE: The purpose of this study is to investigate the prevalence of pain, pain management, and impact of recent pain on daily functioning in patients with head and neck cancer (HNC) and patients with other cancers. METHODS: This multi-center survey was conducted by using Brief Pain Inventory questionnaire to evaluate pain status and its impact on daily functioning. RESULTS: A total of 3289 patients were analyzed including 708 HNC patients and 2581 patients with other cancers. The overall pain prevalence was 69.17%. A higher percentage of HNC patients had recent pain (60.59 vs. 44.01%, P < 0.001), required pain management (86.29 vs. 72.03%, P < 0.001), and used any analgesics (53.81 vs. 34.52%, P < 0.001). HNC patients with pain management had a higher prevalence of recent pain (85.83 vs. 81.14%, P = 0.044) and a slightly lower satisfaction rate (74.00 vs. 79.70%, P = 0.070). Regarding the impact of pain on daily functioning, HNC patients had a lower mean interference score for general activity such as walking, normal work, sleep, and life enjoyment. CONCLUSIONS: The HNC patients may need more intensive pain management to achieve optimal pain control and maintain daily functioning.

RFA experiences, indications and clinical outcomes.

BACKGOUND: Early-stage breast cancer is increasingly detected by screening mammography, and we aim to establish radiofrequency ablation therapy (RFA) as a minimally invasive, cost-efficient, and cosmetically acceptable local treatment. Although there were many studies on resection after RFA, none of them provided sufficient evidence to support RFA as a standard therapy for breast cancer. RESULTS: In our Phase I study, localized tumors with a maximum diameter of 2 cm, preoperatively diagnosed by imaging and histopathology, were treated with RFA. A 90% complete ablation rate was confirmed histopathologically. Our phase II multicenter study of RFA without resection for early breast cancer will evaluate the long-term safety and efficacy of RFA as well as its cosmetic results, which are a perceived advantage of this technique. We started a phase III multicenter study to demonstrate the non-inferiority of RFA compared with standard treatment (breast-conserving surgery) in terms of ipsilateral breast tumor recurrence (IBTR) rate, which is the best index of local control. CONCLUCION: To standardize RFA for breast cancer, the results of our multicenter study, Radiofrequency Ablation Therapy for Early Breast Cancer as Local Therapy (the RAFAELO study) that began in 2013, are eagerly awaited.

Lessons learned conducting a multi-center trial with a military population: The Tinnitus Retraining Therapy Trial.

Background The Tinnitus Retraining Therapy Trial (TRTT), a randomized, placebo-controlled, multi-center trial, evaluated the efficacy of tinnitus retraining therapy and its individual components, tinnitus-specific educational counseling and sound therapy versus the standard of care, in military practice to improve study participants' quality of life. The trial was conducted at six US military hospitals to take advantage of the greater prevalence of tinnitus in the military population. Methods During the trial, various challenges arose that were uniquely related to the military setting. To convey these challenges to investigators planning future multi-center trials in military hospitals, we itemized various challenges that arose during the trial, interviewed clinic directors and coordinators to elicit their viewpoints, and then collated and organized their responses, together with those challenges presented while conducting the Tinnitus Retraining Therapy Trial. Results We encountered challenges in site selection, the approval process, administrative issues, study personnel training and retention, participant recruitment methods and issues, adherence to protocol, reimbursement issues, and military security. Site selection involved visiting 20 military hospitals to identify six sites that enrolled and followed study participants. We found that commitment for the trial must be obtained from the full military chain of command, but with ongoing changes in staff or military priorities, initial commitments were insufficient to sustain support throughout the entire trial. More time is required to obtain necessary administrative approvals by various military authorities and institutional review boards than is typically experienced in civilian settings. Recruitment strategies must be flexible due to changing military regulations regarding display of materials. Protracted periods of inactivity were due to sequestration and delays in institutional review board approval of required study personnel or protocol amendments. While mostly adherent to the protocol, study staff had difficulties in integrating study visits into the military clinical schedule. Unexpected study expenses revolved around hiring civilian study staff and obtaining associated security clearance while maintaining a consistent flow of funds to each site. The added expense negated cost savings realized by conducting the National Institutes of Health-funded trial at federal institutions, whose personnel could not be reimbursed for their efforts. Military security concerns impacted the use of web-based data systems and led to increased time and effort required for site visits. Conclusion Overall, US military hospitals provide a unique setting to conduct multi-center trials. Challenges arise mainly due to ever-changing authority personnel and military priorities. Pre-planning and flexibility are keys in overcoming these challenges. Multi-center trials conducted in the military will likely take longer to initiate and complete than those in the civilian sector due to multiple levels of command and administrative approvals.

Inter-rater variability of visual interpretation and comparison with quantitative evaluation of 11C-PiB PET amyloid images of the Japanese Alzheimer's Disease Neuroimaging Initiative (J-ADNI) multicenter study.

PURPOSE: The aim of this study was to assess the inter-rater variability of the visual interpretation of 11C-PiB PET images regarding the positivity/negativity of amyloid deposition that were obtained in a multicenter clinical research project, Japanese Alzheimer's Disease Neuroimaging Initiative (J-ADNI). The results of visual interpretation were also compared with a semi-automatic quantitative analysis using mean cortical standardized uptake value ratio to the cerebellar cortex (mcSUVR). METHODS: A total of 162 11C-PiB PET scans, including 45 mild Alzheimer's disease, 60 mild cognitive impairment, and 57 normal cognitive control cases that had been acquired as J-ADNI baseline scans were analyzed. Based on visual interpretation by three independent raters followed by consensus read, each case was classified into positive, equivocal, and negative deposition (ternary criteria) and further dichotomized by merging the former two (binary criteria). RESULTS: Complete agreement of visual interpretation by the three raters was observed for 91.3% of the cases (Cohen κ = 0.88 on average) in ternary criteria and for 92.3% (κ = 0.89) in binary criteria. Cases that were interpreted as visually positive in the consensus read showed significantly higher mcSUVR than those visually negative (2.21 ± 0.37 vs. 1.27 ± 0.09, p < 0.001), and positive or negative decision by visual interpretation was dichotomized by a cut-off value of mcSUVR = 1.5. Significant positive/negative associations were observed between mcSUVR and the number of raters who evaluated as positive (ρ = 0.87, p < 0.0001) and negative (ρ = -0.85, p < 0.0001) interpretation. Cases of disagreement among raters showed generally low mcSUVR. CONCLUSIONS: Inter-rater agreement was almost perfect in 11C-PiB PET scans. Positive or negative decision by visual interpretation was dichotomized by a cut-off value of mcSUVR = 1.5. As some cases of disagreement among raters tended to show low mcSUVR, referring to quantitative method may facilitate correct diagnosis when evaluating images of low amyloid deposition.

Asian consortium on radiation dose of pediatric cardiac CT (ASCI-REDCARD).

BACKGROUND: With incremental utilization of pediatric cardiac CT in congenital heart disease, it is imperative to define its current radiation dose levels in clinical practice in order to help imagers optimize CT protocols, particularly in Asia and other developing countries where CT physicists are not readily available. OBJECTIVE: To evaluate current radiation dose levels and influencing factors in cardiac CT in children with congenital heart disease in Asia by conducting a retrospective multi-center, multi-vendor study. MATERIALS AND METHODS: We included 1,043 pediatric cardiac CT examinations performed in 8 centers between January 2014 and December 2014 to evaluate congenital heart disease. In five weight groups, we calculated radiation dose metrics including volume CT dose index, size-specific dose estimate, dose-length product and effective dose. Age at CT exam, gender, tube voltage, scan mode, CT indication and image reconstruction algorithm were analyzed to learn whether they influenced CT radiation dose. RESULTS: Volume CT dose index, size-specific dose estimate, dose-length product and effective dose of pediatric cardiac CT showed variations in the range of 4.3-23.8 mGy, 4.9-17.6 mGy, 55.8-501.3 mGy∙cm and 1.5-3.2 mSv, respectively, within five weight groups. Gender, tube voltage, scan mode and cardiac function assessment significantly influenced CT radiation dose. CONCLUSION: This multi-center, multi-vendor study demonstrated variations in radiation dose metrics of pediatric cardiac CT reflecting current practice in Asia. Gender, tube voltage, scan mode and cardiac function assessment should be considered as essential radiation dose-influencing factors in developing optimal pediatric cardiac CT protocols.