Patient Background Characteristics Research Articles

Does Primary Tumor Resection in Patients with Metastatic Primary Mobile Vertebral Column Sarcoma Improve Survival?

Primary mobile vertebral column sarcoma is an exceedingly rare malignancy. Although primary tumor resection has been reported to prolong survival in patients with metastatic bone sarcoma, whether primary tumor resection in patients with advanced primary mobile vertebral column sarcoma is associated with survival remains unclear owing to the rarity of this pathological entity. Using the Surveillance, Epidemiology, and End Results database, 182 patients with metastatic primary mobile vertebral column sarcoma were identified between 1983 and 2015. Of the 182 patients enrolled, 101 patients (55%) underwent primary tumor resection (Surgery group) and 81 patients (45%) did not undergo resection (No Surgery group). To account for imbalances in the basic characteristics of patients between groups, propensity score matching was performed. Survival analysis was performed by weighted Cox proportional hazards modeling to calculate hazard ratios. After adjusting for patient background characteristics, 138 patients were included for the analysis (Surgery group: 69 patients; No Surgery group: 69 patients). The Surgery group did not show improved cancer-specific survival (hazard ratio= 0.73, 95% CI 0.49-1.10). Similarly, the Surgery group did not show improved overall survival compared with the No Surgery group (hazard ratio= 0.80, 95% CI 0.55-1.16). To our knowledge, this is the first study to indicate that surgical resection for advanced primary mobile vertebral column sarcoma does not have a positive impact on survival.

Survival after recurrence following surgical resected non-small cell lung cancer: A multicenter, prospective cohort study

ObjectivesThe optimal treatment for recurrent non–small cell lung cancer (NSCLC) has not been standardized. In this prospective cohort study, we evaluated post-recurrence survival (PRS) after treatment of recurrent NSCLC and identified prognostic factors after recurrence. MethodsThis multicenter prospective cohort study was conducted in 14 hospitals. The inclusion criteria for this study were patients with recurrence after radical resection for NSCLC. Information about the patient characteristics at recurrence, tumor-related variables, primary surgery, and treatment for recurrence was collected. After registration, follow-up data, such as treatment and survival outcomes, were obtained every 3 months. ResultsFrom 2010 to 2015, 505 cases were enrolled, and 495 cases were analyzed. As initial treatment for recurrence, 263 patients (53%) received chemotherapy, 46 (9%) received chemoradiotherapy, 98 (20%) had definitive radiotherapy, 14 (3%) received palliative radiotherapy, and 31 (6%) underwent surgical resection. The remaining 43 patients (9%) received supportive care. The median PRS and 5-year survival rates for all cases were 30 months and 31.9%, respectively. The median PRS according to the initial treatment was as follows: supportive care, 8 months; palliative radiotherapy, 16 months; definitive radiotherapy, 30 months; chemotherapy, 31 months; chemoradiotherapy, 35 months; and surgery, not reached. A multivariate analysis showed that the age, gender, performance status, histology presence of symptoms, duration from primary surgery to recurrence, and number of recurrent foci were independent prognostic factors for PRS. ConclusionsThe PRS of patients with recurrent NSCLC was different depending on the patient's background characteristics and initial treatment for recurrence.

Long-term outcomes of open modified inferior capsular shift for traumatic anterior shoulder instability: over 20 years of follow-up.

This study aimed to assess the long-term outcomes of the open modified inferior capsular shift procedure across more than 20 years in patients with traumatic anterior shoulder instability. Participants in this study comprised 84 patients (86 shoulders; 67 men, 17 women). Mean follow-up was 28.0 years. We compared the recurrent instability rate after surgery, apprehension, revision rate, satisfaction, return to preinjury sporting activity, and patient background characteristics between recurrent and nonrecurrent groups. Twenty-seven patients who were examined directly were evaluated for differences in range of motion and muscle strength between affected and nonaffected sides. Clinical outcome scores used for this study were the Western Ontario Shoulder Instability Index and the Rowe score. Nine shoulders (10.5%) showed recurrent instability, as dislocation in 3 shoulders and subluxation in 6 shoulders, but no revisions were required. All patients with recurrent instability were males with new trauma. Three shoulders developed recurrent instability ≤5 years after surgery, and the remaining 6 shoulders showed recurrent instability >5 years after surgery. No significant differences in any patient characteristic were identified between the recurrent and nonrecurrent groups. Significant differences between affected and nonaffected sides were seen in the mean active range of motion or muscle strength for external rotation in the anatomic position or in 90° of abduction. Western Ontario Shoulder Instability Index and Rowe score were significantly worse in the recurrent group than in the nonrecurrent group. Patients reported that 84 shoulders (97.7%) were "much better." Most athletes (88.4%) had returned to sports activity at a level >70%. We investigated long-term outcomes of the open modified inferior capsular shift procedure for traumatic anterior shoulder instability. Our data suggest that recurrent instability might result from new trauma even if a long time has passed since the open modified inferior capsular shift procedure, so follow-up should be continued as long as possible after surgery. As in other reports, satisfaction was high and clinical scores were good. We thus believe this surgical method offers good results even after more than 20 years.

Characteristics, treatment, and outcomes of Myasthenia Gravis in COVID-19 patients: A systematic review

ObjectiveRecent studies suggest that the clinical course and outcomes of patients with coronavirus disease 2019 (COVID-19) and myasthenia gravis (MG) are highly variable. We performed a systematic review of the relevant literature with a key aim to assess the outcomes of invasive ventilation, mortality, and hospital length of stay (HLoS) for patients presenting with MG and COVID-19. MethodsWe searched the PubMed, Scopus, Web of Science, and MedRxiv databases for original articles that reported patients with MG and COVID-19. We included all clinical studies that reported MG in patients with confirmed COVID-19 cases via RT-PCR tests. We collected data on patient background characteristics, symptoms, time between MG and COVID-19 diagnosis, MG and COVID-19 treatments, HLoS, and mortality at last available follow-up. We reported summary statistics as counts and percentages or mean±SD. When necessary, inverse variance weighting was used to aggregate patient-level data and summary statistics. ResultsNineteen studies with 152 patients (mean age 54.4 ± 12.7 years; 79/152 [52.0%] female) were included. Hypertension (62/141, 44.0%) and diabetes (30/141, 21.3%) were the most common comorbidities. The mean time between the diagnosis of MG and COVID-19 was7.0 ± 6.3 years. Diagnosis of COVID-19 was confirmed in all patients via RT-PCR tests. Fever (40/59, 67.8%) and ptosis (9/55, 16.4%) were the most frequent COVID-19 and MG symptoms, respectively. Azithromycin and ceftriaxone were the most common COVID-19 treatments, while prednisone and intravenous immunoglobulin were the most common MG treatments. Invasive ventilation treatment was required for 25/59 (42.4%) of patients. The mean HLoS was 18.2 ± 9.9 days. The mortality rate was 18/152 (11.8%). ConclusionThis report provides an overview of the characteristics, treatment, and outcomes of MG in COVID-19 patients. Although COVID-19 may exaggerate the neurological symptoms and worsens the outcome in MG patients, we did not find enough evidence to support this notion. Further studies with larger numbers of patients with MG and COVID-19 are needed to better assess the clinical outcomes in these patients.

Impact of eliminating urethral catheterization following ureterorenoscopic lithotripsy.

To show that elimination of a urethral catheter in ureterorenoscopic lithotripsy cases is not disadvantageous. We reviewed 164 non-catheterized patients (experimental group) and 656 catheterized patients (control group) with renal or ureteral stones treated at our institution. Inclusion criteria were initial operation, patient age 18 to 75 years, no dysuria, and no preoperative febrile urinary tract infection due to calculi. The primary areas of evaluation were patient background, stone characteristics, perioperative factors, and postoperative evaluation results. The proportion of women was significantly lower (24.4% vs 37.2%; P = 0.01) and the proportion of multiple stone cases was significantly higher (34.9% vs 19.2%; P < 0.001) in the experimental as compared to the control group, while there were no significant differences for patient background or stone characteristics. The percentages of short-term preoperative stent insertion (72.0% vs 33.0%; P = 0.009) and negative preoperative urine culture cases (58.0% vs 23.0%; P < 0.001) were significantly higher in the experimental than in the control group, with no differences regarding other perioperative factors. There was no significant difference for complete stone clearance rate between the groups (P = 0.339), while only one patient underwent re-catheterization and there were no cases of urinary retention. Interestingly, the rate of postoperative febrile urinary tract infection was significantly lower (P = 0.024) in the experimental (5.7%) than in the control (9.0%) group. Postoperative urethral catheterization can be eliminated in low-risk ureterorenoscopic lithotripsy cases, although additional studies are needed.

CEFAZOLIN PROPHYLACTIC EFFICACY ON PROSTHETIC JOINT INFECTION AFTER PRIMARY HIP ARTHROPLASTY.

Perioperative deep prosthetic joint infection (PJI) is a serious postoperative complication of total hip arthroplasty (THA). We aimed to compare the efficacy of cefazolin administered within 24 and 48 h of primary THA for PJI prophylaxis. In this retrospective study, 720 patients were divided into two groups depending on whether cefazolin was administered as a single injection of 2 g twice daily within 24 (24-h group) or 48 h of surgery and the following day (48-h group). Sex, age at surgery, body mass index, co-existing diseases, blood test data, and PJI risk factors were evaluated. The 24- and 48-h groups included 364 and 356 patients, respectively. Diabetes mellitus was the most common risk factor for PJI in both groups. The corresponding incidence of perioperative deep PJI following primary THA was 0.55% and 0.28% in the 24- and 48-h groups, respectively. There was no significant difference in patient background characteristics between the groups. Cefazolin administration within 24 h of primary THA may be appropriate for perioperative deep PJI. Level of Evidence II; Retrospective study .

The Clinical Impact of Synchronous and Metachronous Other Primary Cancer in Gastric Cancer Patients Who Receive Curative Treatment.

The present study evaluated the clinical characteristics and prognostic factors of gastric cancer (GC) patients with synchronous and metachronous other primary cancer who received curative treatment for GC. The study included 244 patients who underwent curative treatment for GC between 2005 and 2018. The risk factors for the overall survival (OS) and recurrence-free survival (RFS) were identified. A total of 244 patients were included in this study. Among them, 58 patients were diagnosed with synchronous and metachronous other primary cancer. When comparing the patient background characteristics and clinical course between GC patients without and with synchronous and metachronous other primary cancer, the background, postoperative surgical complications, and details of adjuvant treatment were similar between the two groups. The 3- and 5-year OS rates in GC patients with synchronous and metachronous other primary cancer were 69.7% and 48.0%, respectively, while those in patients without synchronous and metachronous other primary cancer were 80.6% and 74.3%, respectively, showing a statistically significant difference (p<0.001) The synchronous and metachronous other primary cancer status was included in the final multivariate analysis model (hazard ratio=2.201; 95% confidence interval=1.229-3.942; p=0.008). Synchronous and metachronous other primary cancer status is a prognostic factor in GC patients. Therefore, synchronous and metachronous other primary cancer patients need both other primary cancer and GC follow-up to improve their survival.

Effects of Patient Background and Treatment Strategy on Clinical Outcomes After Coronary Intervention for Calcified Nodule Lesions.

Background: The presence of a calcified nodule (CN) is associated with unfavorable clinical outcomes after percutaneous coronary intervention (PCI). This study clarified the optimal management of CNs by reassessing the PCI strategy in association with patient background characteristics and clinical outcomes. Methods and Results: Among 5,332 consecutive PCI cases managed using intra-coronary imaging, CNs were found in 167 lesions (3.1%). CNs were predominantly located at the proximal or mid-right coronary artery (RCA; 62%). More than half presented clinically as acute coronary syndrome (ACS; 56%). All-cause mortality and the target lesion revascularization (TLR) rate at 1 year were 13% and 23%, respectively. Multivariate analysis revealed that hemodialysis, diabetes, and ACS were independent risk factors for all-cause death, whereas hemodialysis and RCA location were independent risk factors for TLR. Regarding the PCI strategy, not using rotational atherectomy (RA) was significantly associated with restenosis, whereas placing a drug-eluting stent (DES) was not. Conclusions: Both hemodialysis and RCA location were strong predictors of poor outcomes after PCI for CN. Because not using RA was significantly associated with restenosis, it may be better to use RA whenever possible.

MPC-7 Clinical features of Diffuse hemispheric glioma, H3 G34-mutant in children and young adults

INTRODUCTION: H3F3A G34R/V mutated gliomas are seen predominantly in children and young adults, and have been proposed as “Diffuse hemispheric glioma, H3 G34-mutant” in cIMPACT-NOW Update 6. However, the clinical features of the tumor have not been fully elucidated. METHODS: We retrospectively reviewed 4 cases with H3G34R mutation among 40 cases diagnosed as glioblastoma under 30 years old or primitive neuroectodermal tumor (PNET) in our hospital. RESULTS: There were one male and three female patients with a median age of 21.5 years (range: 17–27 years). All lesions were localized in the cerebral hemispheres, and the initial symptoms were headache in two cases and seizures in two cases. On imaging, there was one case with poor contrast, and unlike the infiltrative growth pattern of the other three contrasted cases, it showed a well-defined mass lesion. DWI showed high signal in all four cases, reflecting the high cell density in histopathology. All cases were IDH-wildtype. CONCLUSION: Although the patient background and genetic characteristics of the glioma with H3 G34R/V mutation at our institution were generally consistent with previous reports, there were some cases with atypical imaging findings. Further investigation is required for a deeper understanding of the clinical features of this tumor.

Hospitalised versus outpatient COVID-19 patients' background characteristics and comorbidities: A systematic review and meta-analysis.

This study aimed to systematically assess COVID‐19 patient background characteristics and pre‐existing comorbidities associated with hospitalisation status. The meta‐analysis included cross‐sectional, cohort, and case‐series studies with information on hospitalisation versus outpatient status for COVID‐19 patients, with background characteristics and pre‐existing comorbidities. A total of 1,002,006 patients from 40 studies were identified. Significantly higher odds of hospitalisation were observed in Black individuals (OR = 1.33, 95% CI: 1.04–1.70), males (OR = 1.59, 95% CI: 1.43–1.76), and persons with current/past smoking (OR = 1.59, 95% CI: 1.34–1.88). Additionally, individuals with pre‐existing comorbidities were more likely to be hospitalised [asthma (OR = 1.22, 95% CI: 1.02–1.45), COPD (OR = 3.68, 95% CI: 2.97–4.55), congestive heart failure (OR = 6.80, 95% CI: 4.97–9.31), coronary heart disease (OR = 4.40, 95% CI: 3.15–6.16), diabetes (OR = 3.90, 95% CI: 3.29–4.63), hypertension (OR = 3.89, 95% CI: 3.34–4.54), obesity (OR = 1.98, 95% CI: 1.59–2.46) and renal chronic disease (OR = 5.84, 95% CI: 4.51–7.56)]. High heterogeneity and low publication bias among all factors were found. Age was not included due to the large variability in the estimates reported. In this systematic review/meta‐analysis for patients with COVID‐19, Black patients, males, persons who smoke, and those with pre‐existing comorbidities were more likely to be hospitalised than their counterparts. Findings provide evidence of populations with higher odds of hospitalisation for COVID‐19.

Oral corticosteroid dosage and clinical presentation of psychiatric conditions after steroid use: A consultation-liaison psychiatry service's experience.

AimPsychiatric disturbances are the major adverse effects of corticosteroids. There are no consistent conclusions regarding changes in steroid dosage and the incidence of psychiatric conditions, due in part to the lack of consistent evaluation criteria. The purpose of this research was to determine the incidence and dose‐dependency of psychiatric conditions as assessed by trained psychiatrists.MethodsA retrospective chart review was conducted at a university hospital in Japan. We identified inpatients receiving oral prednisolone treatment, who were referred to the consultation‐liaison psychiatry team from April 2015 to March 2018. Patients were divided into high‐dose (≥0.5 mg/kg/day) and low‐dose (<0.5 mg/kg/day) groups. We investigated the associations between steroid dosage and incidence of psychiatric conditions.ResultsA total of 93 patients (35 in the high‐dose group, 58 in the low‐dose group) were included. Various psychiatric conditions, such as insomnia, delirium, depression, and psychosis, occurred during steroid therapy. The most common condition was insomnia (72%). We observed no significant differences in the patient background characteristics and the incidence of most psychiatric conditions between the high‐dose and low‐dose groups. However, there were more patients with delirium in the low‐dose group than in the high‐dose group.ConclusionsBased on the accurate assessment of psychiatric conditions by psychiatrists, our analysis suggests that, among inpatients referred to a consultation‐liaison psychiatry team, the incidence of psychiatric conditions, with the exception of delirium, is independent of the dose of oral prednisolone.

Evaluating an integrated care pathway for frail elderly patients in Norway using multi-criteria decision analysis

BackgroundTo provide value-based care for patients with multi-morbidity, innovative integrated care programmes and comprehensive evaluations of such programmes are required. In Norway, a new programme called “Holistic Continuity of Patient Care” (HCPC) addresses the issue of multi-morbidity by providing integrated care within learning networks for frail elderly patients who receive municipal home care services or a short-term stay in a nursing home. This study conducts a multi-criteria decision analysis (MCDA) to evaluate whether the HCPC programme performs better on a large set of outcomes corresponding to the ‘triple aim’ compared to usual care.MethodsProspective longitudinal survey data were collected at baseline and follow-up after 6-months. The assessment of HCPC was implemented by a novel MCDA framework. The relative weights of importance of the outcomes used in the MCDA were obtained from a discrete choice experiment among five different groups of stakeholders. The performance score was estimated using a quasi-experimental design and linear mixed methods. Performance scores were standardized and multiplied by their weights of importance to obtain the overall MCDA value by stakeholder group.ResultsAt baseline in the HCPC and usual care groups, respectively, 120 and 89 patients responded, of whom 87 and 41 responded at follow-up. The average age at baseline was 80.0 years for HCPC and 83.6 for usual care. Matching reduced the standardized differences between the groups for patient background characteristics and outcome variables. The MCDA results indicated that HCPC was preferred to usual care irrespective of stakeholders. The better performance of HCPC was mostly driven by improvements in enjoyment of life, psychological well-being, and social relationships and participation. Results were consistent with sensitivity analyses using Monte Carlo simulation.ConclusionFrail elderly with multi-morbidity represent complex health problems at large costs for society in terms of health- and social care. This study is a novel contribution to assessing and understanding HCPC programme performance respecting the multi-dimensionality of desired outcomes. Integrated care programmes like HCPC may improve well-being of patients, be cost-saving, and contribute to the pursuit of evidence based gradual reforms in the care of frail elderly.

Influence of maxillary antrolith on the clinical outcome of implants placed simultaneously with osteotome sinus floor elevation: A retrospective radiographic study.

Large antroliths and those located adjacent to the sinus floor can affect clinical interventions and increase the difficulty of implant placement performed simultaneously with osteotome sinus floor elevation surgery. This retrospective study investigated the clinical outcomes of implants placed simultaneously with osteotome sinus floor elevation subjacent to maxillary antroliths. Twenty implants inserted subjacent to or intruding into the antrolith after sinus floor elevation were evaluated in 18 patients. Cone-beam computed tomography (CBCT) was used to measure antrolith size and membrane thickness at sites of osteotome sinus floor elevation. Periapical radiographs were used to assess the height of grafted bone. Generalized estimating equation (GEE) analysis was performed to correlate the occurrence of antroliths with patient background characteristics and dental outcomes, based on a sample population of 239, among whom 33 presented antroliths. The 20 implants remained clinically stable over a mean follow-up period of 42.4months. The mean thickness of the sinus membrane at osteotome sites was 5.4 ± 3.3 mm. None of the cases presented sinus membrane perforation or sinus symptoms following osteotome intervention. The mean gain in the height of grafted sinus bone was 4.0 ± 1.4 mm at the last follow-up. The occurrence of antroliths was higher among females and the elderly (>49 years old). The multivariable GEE analysis showed that the adjusted odds ratio for the occurrence of antroliths with root canal fillings was significantly lower than those without root canal fillings (odds ratio=0.33; 95% confidence interval=0.11-0.96). Our findings indicate that osteotome sinus floor elevation is a surgical procedure with a risk <17%. Thorough planning based on CBCT and careful management during surgery can eliminate the negative effects of antroliths on implant performance.

Factors associated with bleeding events during catheter ablation with uninterrupted periprocedural edoxaban for atrial fibrillation: a subanalysis of the KYU-RABLE study

BackgroundData are limited on patient background characteristics associated with catheter ablation (CA)-related bleeding events in Japanese patients with non-valvular atrial fibrillation receiving uninterrupted periprocedural edoxaban. This subanalysis of the KYU-RABLE study focused on univariate and multivariate analyses to identify correlations between bleeding events and baseline patient demographics and CA-related characteristics.MethodsPatients with non-valvular atrial fibrillation (NVAF) enrolled from the KYU-RABLE study were included in the study. We performed univariate and multivariate analyses to investigate the correlation of major, minor, and clinically relevant non-major bleeding events with the patient baseline data at enrollment, and with CA procedures.ResultsA total of 513 NVAF patients were included in the full analysis set. Univariate analysis showed that the incidence of the bleeding events was higher in patients with HAS-BLED score ≥ 3 compared with those with a score < 3 (odds ratio [OR]: 9.48, 95% CI: 2.36–38.01; p = 0.002), in those with creatinine clearance (CrCL) ≤50 mL/min compared with those with CrCL > 50 mL/min (OR: 10.59, 95% CI: 3.65–30.79; p < 0.0001), and in those receiving edoxaban 30 mg compared with those receiving edoxaban 60 mg (OR: 3.49, 95% CI: 1.18–10.38; p = 0.025). Multivariate analysis showed that HAS-BLED score ≥ 3 (OR: 7.93, 95% CI: 1.66–37.88; p = 0.0094) and CrCl ≤ 50 mL/min (OR: 7.78, 95% CI: 2.17–27.90; p = 0.0016) were significant predictors of bleeding events among KYU-RABLE patients.ConclusionsThese predictors of CA-related bleeding events may allow informed decision-making and better AF patient selection for CA with uninterrupted periprocedural edoxaban.Trial registrationKYU-RABLE, UMIN000029693. Registered 1 December 2017.

Analysis of SARS-CoV-2 PCR and Chest CT Findings at a Single Facility in Tokyo (Machida Municipal Hospital)

Introduction The SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) test is useful for diagnosing COVID-19, and the RT-PCR positive rate is an important indicator for estimating the incidence rate and number of infections. COVID-19 pneumonia is also associated with characteristic findings on chest CT, which can aid in diagnosis. Methods We retrospectively evaluated patient background characteristics, the number of cases, the positivity rate, and chest CT findings for positive and negative cases in 672 patients who underwent RT-PCR for suspected COVID-19 at our hospital between April 3 and August 28, 2020. In addition, we compared trends in the positive rates at approximately weekly intervals with trends in the number of new infections in Machida City, Tokyo. Results The study included 323 men and 349 women, with a median age of 46 years (range: 1 month–100 years). RT-PCR findings were positive in 37 cases, and the positive rate was 5.51%. Trends in the positive rate at our hospital and the number of new COVID-19 cases in the city were similar during the study period. Among patients with positive results, 15 (40.5%) had chest CT findings, and 14 had bilateral homogeneous GGOs. Among patients with negative results, 190 had chest CT findings at the time of examination, and 150 were diagnosed with bacterial pneumonia or bronchitis, with main findings consisting of consolidations and centrilobular opacities. Only 11 of these patients exhibited bilateral homogeneous GGOs. Conclusion Bilateral homogeneous GGOs are characteristic of COVID-19 pneumonia and may aid in the diagnosis of COVID-19.

Evaluating mechanisms of change in an oral hygiene improvement trial with older adults

BackgroundThis paper compares the relationship between theoretically-driven mechanisms of change and clinical outcomes across two different interventions to improve oral hygiene of older adults participating in a group randomized trial.MethodsSix low-income senior residences were paired and randomized into two groups. The first received a face to face counseling intervention (AMI) and the second, a peer-facilitated health campaign (three oral health fairs). Both were based on Fishbein’s Integrated Model. 331 participants were recruited at baseline and 306 completed the post-assessment one month after intervention. Clinical outcomes were Gingival Index (GI) and Plaque score (PS), collected by calibrated dental hygienists. Surveys obtained data on patient background characteristics and ten mechanisms of change including oral health beliefs, attitudes, norms and behaviors. GLMM was used to assess the effects of time, intervention arm, participant characteristics, intervention mechanisms and differences between the two interventions over time in relation to outcomes.ResultsAt baseline, both groups had similar background characteristics. Both groups improved significantly in outcomes. Overall GI scores changed from baseline mean of 0.38 (SD = .032) to .26 (SD = .025) and PS scores changed from baseline mean of 71.4 (SD = 18%) to 59.1% (SD = 21%). T-tests showed that fears of oral disease, oral health intentionality, oral health norms, worries about self-management of oral health, flossing frequency and sugar control improved significantly in both interventions from baseline to post intervention. Oral health self-efficacy, perceived risk of oral health problems, oral health locus of control and brushing frequency improved significantly only in the counseling intervention. GLMM models showed that the significant predictors of GI improvement were intentionality to perform oral hygiene, locus of control, and improvement in frequency of brushing and flossing in association with the counseling intervention. Predictors of PS improvement were worries about oral hygiene self-management and fear of oral diseases, in association with the counseling intervention. In the reduced final models, only oral health locus of control (predicting GI) and fears of oral diseases (predicting PS) were significant in association with the counseling intervention. Locus of control, a key concept in oral hygiene interventions including the IM was the main contributing mechanism for GI improvement. Fear, an emotional response, drove improvement in PS, reinforcing the importance of cognitive/emotional mechanisms in oral hygiene interventions.ConclusionsThough both groups improved in outcomes, GI and PS outcomes improved more in response to the counseling intervention than the campaign. The counseling intervention had an impact on more mechanisms of change than the campaign. Improvements in intervention mechanisms across both interventions however, suggest a closer examination of the campaign intervention impact on outcomes over time.Trial Registration: Clinicaltrials.gov NCT02419144, first posted April 17, 2015.

Siderophore production as a biomarker for Klebsiella pneumoniae strains that cause sepsis: A pilot study

Klebsiella pneumoniae bacteremia-induced sepsis is a clinically important condition with a high mortality rate and various known virulence factors. However, studies on the association of these virulence factors with the occurrence of K. pneumoniae bacteremia-induced sepsis are scarce. We aimed to investigate clinical variables and virulence factors in patients with K. pneumoniae bacteremia-induced sepsis. We retrospectively reviewed the medical records of 76 patients with K. pneumoniae bacteremia between January 2012 and July 2017. Patients were divided into sepsis (n=25) and non-sepsis (n=51) groups. Patient background characteristics, antimicrobial regimens, and prognosis were evaluated. We assessed the distribution of virulence factors related to K. pneumoniae, such as mucoviscosity, capsular polysaccharide, and siderophores. Siderophore production levels were determined by measuring the orange halo zone on chrome azurol S agar plate assay. There were no intergroup differences in male-to-female ratio and age. Multivariable analysis revealed that siderophore production level (p<0.01) was an independent predictor of K. pneumoniae bacteremia-induced sepsis. Furthermore, the optimal cut-off point of siderophore production to predict sepsis was 9.6mm (sensitivity, 86%; specificity, 76%; AUC, 0.81). Siderophore production was an independent predictor of sepsis caused by K. pneumoniae bacteremia. The optimal cut-off point for siderophore production for sepsis occurrence prediction was 9.6mm. To improve outcomes, patients with K. pneumoniae bacteremia-induced sepsis with high siderophore production levels should be managed prudently.

Bayesian adaptive design of early-phase clinical trials for precision medicine based on cancer biomarkers.

Cancer tissue samples obtained via biopsy or surgery were examined for specific gene mutations by genetic testing to inform treatment. Precision medicine, which considers not only the cancer type and location, but also the genetic information, environment, and lifestyle of each patient, can be applied for disease prevention and treatment in individual patients. The number of patient-specific characteristics, including biomarkers, has been increasing with time; these characteristics are highly correlated with outcomes. The number of patients at the beginning of early-phase clinical trials is often limited. Moreover, it is challenging to estimate parameters of models that include baseline characteristics as covariates such as biomarkers. To overcome these issues and promote personalized medicine, we propose a dose-finding method that considers patient background characteristics, including biomarkers, using a model for phase I/II oncology trials. We built a Bayesian neural network with input variables of dose, biomarkers, and interactions between dose and biomarkers and output variables of efficacy outcomes for each patient. We trained the neural network to select the optimal dose based on all background characteristics of a patient. Simulation analysis showed that the probability of selecting the desirable dose was higher using the proposed method than that using the naïve method.

The Influence of Face Gaze by Physicians on Patient Trust: an Observational Study

BackgroundPhysicians’ gaze towards their patients may affect patients’ trust in them. This is especially relevant considering recent developments, including the increasing use of Electronic Health Records, which affect physicians’ gaze behavior. Moreover, socially anxious patients’ trust in particular may be affected by the gaze of the physician.ObjectiveWe aimed to evaluate if physicians’ gaze towards the face of their patient influenced patient trust and to assess if this relation was stronger for socially anxious patients. We furthermore explored the relation between physicians’ gaze and patients’ perception of physician empathy and patients’ distress.DesignThis was an observational study using eye-tracking glasses and questionnaires.ParticipantsOne hundred patients and 16 residents, who had not met before, participated at an internal medicine out-patient clinic.MeasuresPhysicians wore eye-tracking glasses during medical consultations to assess their gaze towards patients’ faces. Questionnaires were used to assess patient outcomes. Multilevel analyses were conducted to assess the relation between physicians’ relative face gaze time and trust, while correcting for patient background characteristics, and including social anxiety as a moderator. Analyses were then repeated with perceived empathy and distress as outcomes.ResultsMore face gaze towards patients was associated with lower trust, after correction for gender, age, education level, presence of caregivers, and social anxiety (β=−0.17, P=0.048). There was no moderation effect of social anxiety nor a relation between face gaze and perceived empathy or distress.ConclusionsThese results challenge the notion that more physician gaze is by definition beneficial for the physician-patient relationship. For example, the extent of conversation about emotional issues might explain our findings, where more emotional talk could be associated with more intense gazing and feelings of discomfort in the patient. To better understand the relation between physician gaze and patient outcomes, future studies should assess bidirectional face gaze during consultations.

Improvement in Cardiometabolic Risk Factors During Smoking Cessation Treatment in Patients with Type 2 Diabetes: A Retrospective Cohort Study.

PurposeSmoking cessation reduces morbidity and mortality of cardiovascular diseases. The purpose of this study was to evaluate the effect during smoking cessation treatment on glycemic control and cardiometabolic risk factors, including blood pressure and lipid levels, in patients with type 2 diabetes.Patients and MethodsThis retrospective cohort study included patients with type 2 diabetes who participated in a smoking cessation program, which comprised health education and medication prescription at an outpatient clinic in combination with a 3-month follow-up by phone. Data on patient background characteristics, cardiometabolic factors, smoking status, body weight, and body mass index before and after the program were collected for analysis.ResultsThe analysis included 241 participants with an average age of 58.6 ± 10.6 years. The rate of successful cessation at three months was 34.0%. Compared with the baseline levels, there were significant decreases in the levels of fasting plasma glucose (10.0 ± 46.8 mg/dL, P = 0.001), HbA1c (0.3 ± 1.4%, P = 0.004), systolic blood pressure (4.6 ± 17.5 mmHg, P < 0.001), diastolic blood pressure (2.9 ± 11.3 mmHg, P < 0.001), and total cholesterol (7.9 ± 42.8 mg/dL, P = 0.020) after participation in the smoking cessation program while there was no significant difference in body weight (0.1 ± 1.2 kg, P = 0.444). After adjustment for covariates, the decreases in HbA1c and total cholesterol levels were significantly better in younger participants and higher baseline nicotine dependence scores were associated with decreases in the levels of blood pressure, fasting plasma glucose, and triglycerides. However, the decrease in smoking amount was not associated with the changes in cardiometabolic factors.ConclusionParticipation in a smoking cessation program was associated with improvements in glycemic control and cardiometabolic risk factors in patients with type 2 diabetes. The observed improvements were associated with participation in the program but not with the decrease in smoking amount.