10-Year oncological outcome report after second conservative treatment for ipsilateral breast tumor event.

Purpose: To analyze long-term oncological outcome after 2nd conservative treatment (2ndCT) for patients with ipsilateral 2nd ipsilateral breast tumor event (2ndIBTE). Materials/methods: In this retrospective observational study (N°F20210402152843), patients with 2ndIBTE underwent 2ndCT (lumpectomy + tumor bed re-irradiation). 3rdIBTE (3rdIBTE-FS), regional relapse- (RRFS) and metastatic disease- (MD-FS) free survivals as well as disease-free (DFS), specific (SS) and overall (OS) survival were analyzed. Late toxicity was reported. Results: Between 09/2000 and 04/2022, 244 patients presented a 2ndIBTE and underwent a 2ndCT. Among them, 113 pts with a minimum follow-up of 60 months were analyzed. Median time interval between 1st and 2ndIBTE was 13.5 years [2-35]. Median 2ndIBTE age was 66.2 years [31-85]. 2ndIBTE were adenocarcinomas (77 %). Tumor size was < 20 mm (86.7 %). 2ndIBTE were grade 1/2 (75 %), with positive hormonal receptor (85 %) and clear surgical margins (no ink on tumor, 90.3 %). In the APBI classification, 21 pts were high-risk (18.6 %), while 77 % were Luminal A/BHer2-. With a MFU of 121.5 months [CI95% 111.7-129.6], 10-year 3rdIBTE-FS was 89 % [83-96]. Then-year RRFS, MDFS, DFS, SS and OS were 94 % [89-100], 89 % [83-96], 78 % [70-87], 95 % [91-100] and 94 % [90 -99] respectively. In multivariate analysis, APBI classification (high-risk; HR2.66 [1.01-7.1], p = 0.049) and tumor size (≥20 mm; HR2.64 [1.02-6.8], p = 0.045) were considered independent prognostic factors for DFS.Ninety-seven late complications were observed (fibrosis 64 %) with 6.2 % G ≥ 3 late toxicity. Cosmetic outcome was excellent/good in 91.2 %. Conclusions: With long follow-up, 2ndIBTE managed with 2ndCT allows second breast preservation without oncological outcome compromise and acceptable G ≥ 3 toxicity.

RC time (resistance × compliance) is related to residual symptom after pulmonary endarterectomy in chronic thromboembolic pulmonary hypertension.

Background: Right ventricular (RV) afterload is widely assessed by pulmonary vascular resistance (PVR). However, RV afterload is underestimated because PVR does not account for the pulsatile load. The pulsatile load is often evaluated by pulmonary arterial compliance (PAC). The RC (resistance-compliance) time, which is calculated from the product of PVR and PAC, is considered to remain constant under medical therapy. However, little is known on how RC time is affected by invasive therapy in chronic thromboembolic pulmonary hypertension (CTEPH). This study aimed to evaluate change of RC time in patients underwent pulmonary endarterectomy (PEA). Furthermore, we investigated the clinical relevance of RC time. Methods: We reviewed consecutive 50 patients except for death case underwent PEA. Baseline clinical parameters including RC time before performing PEA and follow-up were evaluated. Patients was classified as decrease or non-decrease according to change of RC time. Furthermore, we classified patients into a NYHA I group who had no symptom after treatment and a residual symptom group in order to investigate the relationship of RC time to residual symptoms. Results: RC time was significantly decreased after PEA (0.54 ± 0.16 to 0.45 ± 0.12 sec, p < 0.001). Residual symptom after PEA of Decrease group were significantly better than that of Non-decrease group in RC time (12 patients, 40% vs. 11 patients, 78.6%, p < 0.02). Furthermore, multivariate analysis revealed that only RC time after PEA was independently associated with residual symptom (OR 1.026, 95% CI 1.005-1.048; p = 0.017). Conclusions: RC time was decreased after PEA, and might be a possible indicator for predicting PEA success.

Utilization of mechanical prostheses and outcomes of surgical aortic valve replacement at safety net hospitals.

Background: Safety-net hospitals care for a high proportion of uninsured/underinsured patients who may lack access to longitudinal care. The present study characterized the use of mechanical valves and clinical outcomes of surgical aortic valve replacement at safety net hospitals. Methods: All adults undergoing surgical aortic valve replacement were abstracted from the 2016-2018 Nationwide Readmissions Database. Hospitals were divided into quartiles based on volume of all Medicaid and uninsured admissions, with the highest quartile defined as safety net hospitals. Multivariable regression was used to determine the association between safety net hospitals and several outcomes including mechanical valve use, perioperative complications, index hospitalization costs, 90-day readmission, and complications at readmission. Results: Of the 94,580 patients undergoing surgical aortic valve replacement, 14.5% of operations were at safety net hospitals. Patients at safety net hospitals more commonly received mechanical valves (20.3% vs 16.9%, P < .01) compared to those at non-safety net hospitals. After adjustment, safety net hospitals remained associated with a greater odds of mechanical aortic valve use (adjusted odds ratio, 1.13, 95% confidence interval 1.05-1.21). However, operation at safety net hospitals was also associated with increased odds of perioperative complications (adjusted odds ratio 1.10, 95% confidence interval 1.03-1.17) and higher hospitalization costs (ß coefficient +$6.15K, 95% confidence interval +$5.26 - +$7.03) despite similar 90-day readmissions. Upon readmission, safety net hospitals patients were more likely to experience mortality (adjusted odds ratio 1.87, 95% confidence interval 1.18-2.98) and stroke (adjusted odds ratio 2.41, 95% confidence interval 1.23-4.70) compared to those at non-safety net hospitals. Conclusion: Hospital safety net status is associated with increased use of mechanical valves for surgical aortic valve replacement despite also being associated with increased perioperative complications, costs, and significant complications upon readmission. Ability to access adequate follow-up care may be an important consideration for surgical aortic valve replacement at safety net hospitals.

Associations of Four sensitization patterns revealed by Latent Class Analysis with Clinical symptoms: A multi-center study of China.

Background: Because of the significant regional differences in the distribution of allergens, the relationship between anaphylaxis and allergic sensitization is complex in China. Using this large-scale epidemiologic survey, we explore the potential patterns of sensitization to common allergens in mainland China and investigate their relationship with various clinical symptoms. Method: The participants were recruited from 13 medical centers in mainland China from October 2019 to June 2021. Skin prick test (SPT) results that cover 18 common allergens were utilized to diagnose atopic sensitization. The demographic characteristics and clinical information were collected through questionnaires during routine medical follow-up. Latent class analysis (LCA) was conducted to determine the optimal sensitization patterns. The logistic regression was used to assess the associations of different sensitization patterns with allergy symptoms. Findings: A total of 1089 patients who had a positive SPT to at least one of 18 allergens were included for formal analysis. An optimal LCA model with 4 classes was obtained in this study, and the corresponding labels were as follows: Class1, house dust mite sensitization; Class2, low pollen sensitization; Class3, middle pollen sensitization; Class4, high pollen sensitization. The prevalence of different classes varied widely in geographical distribution, which was characterized by Class1 being very common in south and east as well as Class2 in north and west of China. Compared with patients in Class1, those in middle and high pollen sensitization clusters had the higher odds ratios (ORs) of allergic rhinitis and allergic conjunctivitis when controlling for other confounders. However, there was no significant difference between low pollen sensitization and house dust mite sensitization groups in the risks for various clinical performances except dermatitis. Additionally, the adjusted ORs (95% confidence interval) of allergic conjunctivitis and dermatitis for participants in pollen sensitization clusters (Class2, 3 and 4) were 1.56 (1.18, 2.06) and 1.43 (1.09, 1.88) respectively compared with those in Class1. Interpretation: In this study, we identified four sensitization clusters with specific risks of various clinical symptoms using common allergens by adopting LCA. Our findings may contribute to improved diagnosis and potential immunotherapy approaches to allergy in mainland China. Funding: This study was supported by the National Natural Science Foundation of China (81802076 and 81871736), the Guangzhou Science and Technology Foundation (202102010327), the Foundation of SKLRD (MS-2019-06 and Z-2022-09), and the Foundation of GYYY (ZH201904) and ZNSA-2020012.

The efficacy profiles of concurrent chemoradiotherapy with intensity-modulated radiotherapy followed by durvalumab in patients with unresectable stage III non-small cell lung cancer: A multicenter retrospective cohort study.

Purpose: Intensity-modulated radiotherapy (IMRT) is currently used more commonly than 3-dimensional conformal radiation for definitive thoracic radiation. We examined the efficacy profiles of concurrent chemoradiotherapy (CCRT) with IMRT after durvalumab became clinically available. Methods: We reviewed the clinical records of patients with stage III non-small cell lung cancer (NSCLC) treated with CCRT and IMRT at seven centers in Japan and investigated relapse and survival from May 2018 to December 2019. The primary endpoint of this report was progression-free survival (PFS). Results: Among 107 patients enrolled in the study, 87 were sequentially administered durvalumab. From CCRT commencement, patients were followed up for a median period of 29.7 months. The median PFS at the end of the CCRT was 20.7 months. Among the 87 patients, 58 experienced disease relapses, of whom 36 (62.1 %) had distant metastases. Multivariate Cox regression analysis revealed that a favorable response to CCRT, a radiation dose ≥ 62 Gy, and stage IIIA NSCLC were associated with prolonged PFS (all P = 0.04). Multivariate logistic regression by landmark analysis revealed that mortality risk factors were durvalumab treatment duration ≤ 11.7 months, a lower maximum grade of immune-related adverse events, FEV1 < 2805 mL, and radiation dose < 62 Gy (P = 0.01, 0.01, 0.03, and 0.04, respectively). Conclusions: In patients with NSCLC receiving CCRT using IMRT, long PFS was associated with a better response to CCRT, stage IIIA NSCLC, and an increased radiation dose. The duration of durvalumab consolidation also played an essential role in the survival of patients receiving CCRT with IMRT. (250 words).

Severe Acute Respiratory Syndrome by SARS-CoV-2 Infection or Other Etiologic Agents Among Brazilian Indigenous Population: An Observational Study from the First Year of Coronavirus Disease (COVID)-19 Pandemic.

BACKGROUND: Indigenous peoples are vulnerable to pandemics, including to the coronavirus disease (COVID)-19, since it causes high mortality and specially, the loss of elderly Indigenous individuals. METHODS: The epidemiological data of severe acute respiratory syndrome (SARS) by SARS-CoV-2 infection or other etiologic agents (OEA) among Brazilian Indigenous peoples during the first year of COVID-19 pandemic was obtained from a Brazilian Ministry of Health open-access database to perform an observational study. Considering only Indigenous individuals diagnosed with SARS by COVID-19, the epidemiology data were also evaluated as risk of death. The type of sample collection for virus screening, demographic profile, clinical symptoms, comorbidities, and clinical evolution were evaluated. The primary outcome was considered the death in the Brazilian Indigenous individuals and the secondary outcome, the characteristics of Brazilian Indigenous infected by SARS-CoV-2 or OEA, as the need for intensive care unit admission or the need for mechanical ventilation support. The statistical analysis was done using Logistic Regression Model. Alpha of 0.05. FINDINGS: A total of 3,122 cases of Indigenous individuals with SARS in Brazil were reported during the first year of the COVID-19 pandemic. Of these, 1,994 were diagnosed with COVID-19 and 730/1,816 (40.2%) of them died. The death rate among individuals with SARS-CoV-2 was three-fold increased when compared to the group of individuals with OEA. Several symptoms (myalgia, loss of smell, and sore throat) and comorbidities (cardiopathy, systemic arterial hypertension, and diabetes mellitus) were more prevalent in the COVID-19 group when compared to Indigenous individuals with OEA. Similar profile was observed considering the risk of death among the Indigenous individuals with COVID-19 who presented several symptoms (oxygen saturation <95%, dyspnea, and respiratory distress) and comorbidities (renal disorders, cardiopathy, and diabetes mellitus). The multivariate analysis was significant in differentiating between the COVID-19-positive and non-COVID-19 patients [X2 (7)=65.187; P-value<0.001]. Among the patients' features, the following contributed in relation to the diagnosis of COVID-19: age [≥43 years-old [y.o.]; OR=1.984 (95%CI=1.480-2.658)]; loss of smell [OR=2.373 (95%CI=1.461-3.854)]; presence of previous respiratory disorders [OR=0.487; 95%CI=0.287-0.824)]; and fever [OR=1.445 (95%CI=1.082-1.929)]. Also, the multivariate analysis was able to predict the risk of death [X2 (9)=293.694; P-value<0.001]. Among the patients' features, the following contributed in relation to the risk of death: male gender [OR=1.507 (95%CI=1.010-2.250)]; age [≥60 y.o.; OR=3.377 (95%CI=2.292-4.974)]; the need for ventilatory support [invasive mechanical ventilation; OR=24.050 (95%CI=12.584-45.962) and non-invasive mechanical ventilation; OR=2.249 (95%CI=1.378-3.671)]; dyspnea [OR=2.053 (95%CI=1.196-3.522)]; oxygen saturation <95% [OR=1.691 (95%CI=1.050-2.723)]; myalgia [OR=0.423 (95%CI=0.191-0.937)]; and the presence of kidney disorders [OR=3.135 (95%CI=1.144-8.539)]. INTERPRETATION: The Brazilian Indigenous peoples are in a vulnerable situation during the COVID-19 pandemic and presented an increased risk of death due to COVID-19. Several factors were associated with enhanced risk of death, as male sex, older age (≥60 y.o.), and need for ventilatory support; also, other factors might help to differentiate SARS by COVID-19 or by OEA, as older age (≥43 y.o.), loss of smell, and fever. FUNDING: Fundação de Amparo à Pesquisa do Estado de São Paulo (Foundation for Research Support of the State of São Paulo; #2021/05810-7).

Statistical analysis plan: Early mobilization by head-up tilt with stepping versus standard care after severe traumatic brain injury.

BACKGROUND: Early mobilization on a tilt table with stepping versus standard care may be beneficial for patients with severe brain injury, but data from randomized clinical trials are lacking. This detailed statistical analysis plan describes the analyses of data collected in a randomized clinical feasibility trial for early mobilization by head-up tilt with stepping versus standard care after severe traumatic brain injury. METHODS: Primary feasibility outcomes are the proportion of included participants who were randomized out of all screened patients; the proportion of participants allocated to the experimental intervention who received at least 60% of the planned exercise sessions; and safety outcomes such as adverse events and reactions and serious adverse events and reactions. Exploratory clinical outcomes are suspected unexpected serious adverse reactions; and functional outcomes as assessed by the Coma Recovery Scale-Revised at four weeks; Early Functional Ability Scale and Functional Independence Measure at three months. The description includes the statistical analysis plan, including the use of multiple imputations and Trial Sequential Analysis.

Estimated clinical benefit of combining highly conformal target volumes with Volumetric-Modulated Arc Therapy (VMAT) versus conventional flank irradiation in pediatric renal tumors.

BACKGROUND: For decades, Anterior-Posterior/Posterior-Anterior (AP/PA) photon beams were standard-of-care for flank irradiation in children with renal cancer. Recently, highly conformal flank target volumes were defined correcting for postoperative organ shift and intra-fraction motion.By radiotherapy treatment plan comparison, this study aims to estimate the clinical benefits and potential risks of combining highly conformal target volumes with Volumetric-Modulated Arc Therapy (VMAT) versus conventional target volumes with AP/PA beams for flank irradiation. MATERIALS AND METHODS: Twenty consecutive renal tumor cases (left/right-sided:10/10; median age:3.2 years) were selected. Highly conformal flank target volumes were generated for VMAT, while conventional target volumes were used for AP/PA. For each case, the dose to the organs at risk (OARs) and Total Body Volume (TBV) was calculated to compare VMAT with AP/PA treatment plans for a prescribed dose (PD) of 14.4/1.8 Gy. Dose constraint violation of the tail of the pancreas and spleen (Dmean < 10 Gy), heart (D50 < 5 Gy) or mammary buds (Dmean < 10 Gy) were prioritized as potentially beneficial for clinics. RESULTS: Highly conformal Planning Target Volumes (PTV) were smaller than conventional volumes (mean ΔPTVAP/PA-PTVVMAT: 555 mL, Δ60%, p=<0.01). A mean dose reduction favoring VMAT was observed for almost all OARs. Dose constraints to the tail of the pancreas, spleen, heart and mammary buds were fulfilled in 8/20, 12/20, 16/20 and 19/20 cases with AP/PA, versus 14/20, 17/20, 20/20 and 20/20 cases with VMAT, respectively. In 12/20 cases, VMAT prevented the dose constraint violation of one or more OARs otherwise exceeded by AP/PA. VMAT increased the TBV receiving 10% of the PD, but reduced the amount of irradiated TBV for all higher doses. CONCLUSION: Compared to 14.4 Gy flank irradiation using conventional AP/PA photon beams, an estimated clinical benefit by dose reduction to the OARs can be expected in 60% of the pediatric renal tumor cases using highly conformal flank target volumes combined with VMAT.

Longitudinal changes in physical and mental health of older adults with chronic hepatitis B infection: Trajectories and predictors.

Despite the increasing health burden of chronic hepatitis B (CHB) in aging populations, little is known about the course of health-related quality of life (HRQoL) changes. We aimed to assess individual-level longitudinal HRQoL changes in elderly patients with CHB and to examine their correlates. A prospective 5.1 years-cohort study was conducted in community-dwelling adults aged 55 years with hepatitis B surface antigen-positive. Participants underwent serial measurement of HRQoL using the short-form (12) health survey version 2. Of 503 participants, 82.7% remained in good physical health throughout the study period, whereas 9.1% had declining physical health and 8.2% were in poor physical health. We likewise identified three trajectories of mental health changes ("good mental health" [86.9%], "declining mental health" [6.8%], and "poor mental health" [6.4%]). Three baseline characteristics were independently associated with a lower likelihood of remaining physically or mentally healthy: sarcopenic obesity (odds ratio [OR] with 95% confidence interval [95% CI] of 7.5 [2.8-20.5] for poor physical health, 3.1 [1.1-8.4] for declining physical health, 4.3 [1.4-13.0] for poor mental health), a higher number of metabolic abnormalities (OR [95% CI] of 3.6 [1.6-8.0] for poor physical health) and depressed mood (OR [95% CI] of 21.7 [5.8-81.0] for poor physical health, 5.3 [1.4-19.9] for declining physical health, 83.1 [19.7-350.2] for poor mental health, 13.6 [2.9-64.8] for declining mental health). In conclusion, in a cohort of elderly patients with CHB, we demonstrated the heterogeneity and nonlinearity of HRQoL changes and their associations with variations in specific extrahepatic organs/systems.

Pelvic region bone density, soft tissue mass, and injury frequency in female professional ballet dancers and soccer athletes.

We recently observed a high prevalence of low pelvic bone mineral density (BMD) in female professional ballet performers. Because this population is susceptible to musculoskeletal overuse injuries, we aimed to determine which regions of the pelvis may be at greatest risk compared to general population females (GENPOP) as well as professional female soccer players (SOCCER, a comparison to other elite athletes regularly subjected to high degrees of loading). Three groups of age-matched females [(GENPOP; n = 38, 27±1yrs), (BALLET; single company, n = 36, 26±3yrs), (SOCCER; single NWSL® club, n = 34, 25±1yrs)] consented to have their BMD and body composition assessed (DEXA, GE®). In addition to soft tissue and total and regional BMD analyses, a segmental analysis of the pelvis was performed to determine site-specific BMD for the iliac fossa, iliac fossa/iliac crest/ilium combined, pubic bone, ischium, and sacrum. A mixed-model ANOVA followed by a Tukey's post-hoc test was used to compare the groups (Type-I error; α = 0.05). The BALLET group had lower pelvic BMD for all measures (Avg.%Diff. = 15%-27%, p<0.001) compared to the SOCCER group and for the ischium (Avg.%Diff.= 8%; p=0.007) and sacrum (Avg.%Diff. â€‹= â€‹7%; p = 0.028) compared to the GENPOP group. The BALLET group had lower lean mass for all measures compared to the other groups (Avg.%Diff. = 12%-18%; p < 0.01). Professional ballet performers exhibit reduced pelvic region soft tissue and site-specific BMD not previously detected using standard DEXA analyses. These findings highlight which pelvic regions may benefit from preventative strength training and/or nutritional interventions.

Factors Associated With Walking in Older Medical Inpatients.

OBJECTIVE: To identify patient characteristics on admission and daily events during hospitalization that could influence older medical inpatients walking activity during hospitalization. DESIGN: A cohort study. SETTING: Acute hospitalized care. PARTICIPANTS: Premorbidly mobile, nonsurgical, nonelective inpatients (50% women) aged ≥65 years (N=154), with an anticipated ≥3-day inpatient stay were recruited consecutively within 48 hours of hospital admission. Of the 227 patients screened, 69 did not meet study criteria and 4 refused. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Age, comorbidities (Cumulative Illness Rating Scale), cognitive status (6-item Cognitive Impairment Test), falls history and efficacy (Falls Efficacy Scale-International), physical performance (short physical performance battery), and medications were recorded within 2 days of admission. Walking activity (step count) was recorded for 7 days or until discharge. Daily events (procedures, falls, fear of falling, ordered bedrest, devices or treatments that hindered walking [eg, intravenous fluids, wall-mounted oxygen therapy], patient- and nurse-reported medial status, fatigue, sleep quality, physiotherapy, or occupational therapy intervention) were measured on concurrent weekdays. Their associations with daily (log) step count were estimated using linear mixed-effects models, adjusted for patient-characteristics measured at admission. RESULTS: Approximately half of the variability in step count was described at the within-patient level. Multivariable models suggested positive associations with Wednesdays (+25% in step count; 95% confidence interval, 4-53), admission physical performance (+15%, 8-22), improving medical status (+33%, 7-64), negative associations with devices or treatments that hinder walking (-29%, -9 to -44), and instructed bedrest (-69%, -55 to -79). CONCLUSION: Day-to-day step count fluctuated, suggesting considerable scope for intervention. Devices or treatments that hinder walking should be reviewed daily and walking activity should become a clinical priority. Admission physical performance may identify vulnerable patients.

The Interexaminer Reproducibility and Prevalence of Lumbar and Gluteal Myofascial Trigger Points in Patients With Radiating Low Back Pain.

OBJECTIVE: To determine the interexaminer reproducibility for judging the presence, number, and location of leg-pain referring myofascial trigger points, and their prevalence in patients with low back pain with and without concomitant leg pain referral. DESIGN: An interexaminer reproducibility study. SETTING: An outpatient public Hospital Spine Centre in Southern Denmark. PARTICIPANTS: Examiners: experienced examiners (N=2), a chiropractor and a physiotherapist, respectively. Subjects: a case mix of patients with low back pain (N=32) with and without leg pain referral. INTERVENTIONS: A standardized palpation examination protocol of 4 bilateral lumbosacral muscles performed by each examiner. MAIN OUTCOME MEASURES: Reproducibility on presence (measured in Cohen's κ), number (difference and limits of agreement), location (distance between matching marks placed by examiners), and prevalence of myofascial trigger points. RESULTS: Kappa values of the examined muscles were as follows: quadratus lumborum (κ=0.42), gluteus medius (κ=0.83), gluteus minimus (κ=0.74), and piriformis (κ=0.62), with a mean of all examined muscles of kappa=0.66, assessed as substantial agreement. The mean difference in number of trigger points was 0.8, with limits of agreement ranging from -6.4 to 4.9. Mean distance between trigger point locations was 12.9 mm, with 57% only being identified by a single examiner. The prevalence of trigger points was 82.7%, highest in the gluteal region of the painful side. CONCLUSIONS: Inadequate standardization and multiple trigger point sites complicate interexaminer reproducibility on location and number of patients with low back pain and leg pain referral. Nevertheless, substantial interexaminer reproducibility for the trigger point presence appears achievable. Implemented routinely, this relatively simple clinical evaluation procedure could meaningfully enhance diagnostic triage and eventual management.

The Efficacy of Fall Hazards Identification on Fall Outcomes: A Systematic Review With Meta-analysis.

OBJECTIVE: To investigate the efficacy of fall hazards identification programs when compared to no intervention or other fall prevention programs on number of falls, falls incidence, and identifying fall hazards in community-dwelling adults. DATA SOURCES: CINAHL, PubMed, EMBASE, Scopus, and PsychINFO were used to identify articles. STUDY SELECTION: Studies were selected to compare fall hazards identification programs to a control group. Studies were eligible if they were randomized controlled trials and enrolled adults older than 50 years with the incidence rate of falls as an outcome. DATA EXTRACTION: Study or authors, year, sample characteristics, intervention or comparison groups, number of falls, and number of hazards identified in the intervention and control groups, and follow-up were extracted. The risk of bias assessment was performed using the Cochrane Risk of Bias tool. Quality was evaluated with Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach per outcome. DATA SYNTHESIS: A total of 8 studies (N=8) and 5177 participants were included. There was a high risk of bias across the studies mostly due to improper blinding of personnel of the outcome assessor. Pooled estimate effects from 5 studies assessing the incidence rate of falls from 3019 individuals indicated no difference between fall hazards identification programs and control (incidence rate ratio=0.98; 95% confidence interval, 0.87-1.10). CONCLUSIONS: The current study suggests that there may be a benefit for fall hazards programs in reducing incident falls. However, because of a moderate GRADE rating, more large-scale studies with a higher number of falls events and more consistent control groups are required to determine the true effect.

Association between stages of medial compartment osteoarthritis and three-dimensional knee alignment in the supine position: A cross-sectional study.

BACKGROUND: Osteoarthritis (OA) of the knee causes changes in knee alignment. A detailed knowledge of knee alignment is needed for correct assessment of the extent of disease progression, determination of treatment strategy, and confirmation of treatment effectiveness. However, deterioration of knee alignment during progression of OA has not been adequately characterized. The aims of this study were to clarify the changes in three-dimensional static knee alignment as knee OA stage progressed and to lay a foundation for an optimal treatment strategy to prevent knee malalignment. METHODS: A total of 106 knees of 81 patients ((men/women) 45/36; mean age 48.4 ±â€¯19.9 years; body mass index (BMI) 25.7 ±â€¯4.4 kg/m2) were enrolled in this cross-sectional study, comprising 34 (33/1) in Kellgren-Lawrence (KL) grade 0, 17 (8/9) in KL grade 1, 26 (5/21) in KL grade 2, 19 (4/15) in KL grade 3, and 10 (1/9) in KL grade 4. In all cases, computed tomography images were obtained with the subject in a reclined and relaxed position with the knee straight. Three-dimensional bone models were created from the images and knee alignment was calculated with six degrees-of-freedom. Then, 40 knees were selected consisting of 10 sex- and BMI-matched knees from each KL grade group: KL grade 1 (mean age 54.6 ±â€¯8.4 years; BMI 23.3 ±â€¯3.5 kg/m2), grade 2 (64.7 ±â€¯10.9 years; 27.3 ±â€¯3.2 kg/m2), grade 3 (69.2 ±â€¯11.4 years; 27.1 ±â€¯4.3 kg/m2), and grade 4 (71.9 ±â€¯9.2 years; 27.2 ±â€¯3.6 kg/m2). The Mann-Whitney U test with Bonferroni correction for multiple comparisons was used to analyze static alignment (α < 0.05/6). RESULTS: Alignment of the knee in flexion was -4.0 [95% confidence interval (CI): -6.4, -1.5] degrees, -3.4 [-8.0, 1.3] degrees, -0.1 [-3.7, 3.5] degrees, and 0.4 [-0.9, 1.6] degrees in the order of KL grade 1 to 4. There were significant differences between KL grade 1 and 4 (p = 0.0081). Anterior tibial translation was 6.6 [4.6, 8.6] mm, 5.8 [1.9, 9.7] mm, 1.0 [-2.5, 4.5] mm, and 1.3 [-2.4, 5.1] mm in the order of grade 1 to 4. There were significant differences between KL grade 1 and 4 (p = 0.0081). There were no significant differences in lateral tibial translation nor tibial rotation. CONCLUSIONS: The severely osteoarthritic knee joint was flexed and the tibia was displaced posteriorly with respect to the femur. Preventing these changes in alignment would assist in the prevention and treatment of knee OA.

Changes in effort-reward imbalance at work and risk of onset of sleep disturbances in a population-based cohort of workers in Denmark.

OBJECTIVE/BACKGROUND: Associations between exposure to effort-reward imbalance at work (eg, high time pressure/low appreciation) and risk of sleep disturbances have been reported, but the direction of the effect is unclear. The present study investigated changes in effort-reward imbalance and risk of concomitant and subsequent onset of sleep disturbances. METHODS: Participants with sleep disturbances at baseline were excluded. We included participants from a population-based cohort in Denmark (n = 8,464, 53.6% women, mean age = 46.6 years), with three repeated measurements (2012 (T0); 2014 (T1); 2016 (T2)). Changes in effort-reward imbalance (T0-T1) were categorized into 'increase', 'decrease' and 'no change'. Self-reported sleep disturbances (difficulties initiating or maintaining sleep, non-restorative sleep, daytime tiredness) were dichotomized (presence versus absence). We regressed concomitant (T1) and subsequent (T2) sleep disturbances on changes in effort-reward imbalance (T0-T1) and calculated odds ratios (OR) and 95% confidence intervals, adjusted for sex, age, education and cohabitation. RESULTS: At follow-up, 8.4% (T1) and 12.5% (T2) reported onset of sleep disturbances. Increased effort-reward imbalance was associated with concomitant sleep disturbances (T1) (OR = 3.16, 2.56-3.81), whereas decreased effort-reward imbalance was not (OR = 1.22, 0.91-1.63). There was no association between increased effort-reward imbalance and subsequent sleep disturbances (T2) (OR = 1.00, 0.74-1.37). Results were similar for men and women. CONCLUSIONS: Increased effort-reward imbalance was associated with a three-fold higher risk of concomitant onset of sleep disturbances at two-year follow-up, but not subsequent onset of sleep disturbances at four-year follow-up, indicating that changes in effort-reward imbalance have immediate rather than delayed effects on sleep impairment. It is possible that the results from the two-year follow-up were to some extent affected by reverse causality.

Drinking water and sanitation conditions are associated with the risk of malaria among children under five years old in sub-Saharan Africa: A logistic regression model analysis of national survey data.

Current efforts for the prevention of malaria have resulted in notable reductions in the global malaria burden; however, they are not enough. Good hygiene is universally considered one of the most efficacious and straightforward measures to prevent disease transmission. This work analyzed whether improved drinking water and sanitation (WS) conditions were associated with a decreased risk of malaria infection. Data were acquired through surveys published between 2006 and 2018 from the Demographic and Health Program in sub-Saharan Africa (SSA). Multiple logistic regression was used for each national survey to identify the associations between WS conditions and malaria infection diagnosed by microscopy or a malaria rapid diagnostic test (RDT) among children (0-59 months), with adjustments for age, gender, indoor residual spraying (IRS), insecticide-treated net (ITN) use, house quality, and the mother's highest educational level. Individual nationally representative survey odds ratios (ORs) were combined to obtain a summary OR using a random-effects meta-analysis. Among the 247,440 included children, 18.8% and 24.2% were positive for malaria infection based on microscopy and RDT results, respectively. Across all surveys, both unprotected water and no facility users were associated with increased malaria risks (unprotected water: aOR 1.17, 95% CI 1.07-1.27, P = 0.001; no facilities: aOR 1.35, 95% CI 1.24-1.47, P < 0.001; respectively), according to microscopy, whereas the odds of malaria infection were 48% and 49% less among piped water and flush-toilet users, respectively (piped water: aOR 0.52, 95% CI 0.45-0.59, P < 0.001; flush toilets: aOR 0.51, 95% CI 0.43-0.61, P < 0.001). The trends of individuals diagnosed by RDT were consistent with those of individuals diagnosed by microscopy. Risk associations were more pronounced among children with a "nonpoor" socioeconomic status who were unprotected water or no facility users. WS conditions are a vital risk factor for malarial infection among children (0-59 months) across SSA. Improved WS conditions should be considered a potential intervention for the prevention of malaria in the long term.

Higher volume providers are associated with improved outcomes following ERCP for the palliation of malignant biliary obstruction.

BACKGROUND: Relieving malignant biliary obstruction improves quality of life and permits chemotherapy. Outcomes of endoscopic retrograde cholangio-pancratography(ERCP) in inoperable malignant biliary obstruction have been examined in a national cohort to establish factors associated with poor outcomes. METHODS: Hospital Episode Statistics include diagnostic and procedural data for all NHS hospital attendances in England. Patients from 2006 to 2017 with a Hepaticopancreaticobiliary (HPB) malignancy who had undergone ERCP were studied. Patients undergoing a potentially curative operation were excluded. Associations between demographics, co-morbidities, unit ERCP volume and mortality were examined by logistic regression. FINDINGS: 39,702 patients were included; 49.4% were male; median age was 75 (IQR 66-88)years. Pancreatic cancer was the most common tumour (63.9%). Mortality was 4.1%, 9.7% and 19.1% for 7-day, in hospital and 30-day respectively. On multivariable analysis: men (OR 1.20(95%CI 1.14-1.26), p < 0.001); increasing age quintile 78-83(1.73(1.59-1.89), p < 0.001), >83(2.70(2.48-2.94),p < 0.001); most deprived quintile (1.21(1.11-1.32), p < 0.001); increasing co-morbidity score >20(3.36(2.94-3.84),p < 0.001); small bowel malignancy (1.45(1.22-1.72), p < 0.001), intrahepatic biliary malignancy(1.10(1.03-1.17), p = 0.005) and year of ERCP 2006/07 (1.37(1.22-1.55), p < 0.001) were associated with increased 30-day mortality. Extrahepatic biliary tree cancers (0.67(0.61-0.73), p<0.001), high volume providers of ERCP (>318 annually, 0.91(0.84-0.98), p = 0.01) and high volume of ERCP for malignant obstruction (>40 annually (0.91(0.85-0.98), p = 0.014) were negatively associated with 30-day mortality. Patients were less likely to require a second ERCP in high volume providers (>318, 8.0%) compared to low volume ((<204, 13.4%), p<0.001). INTERPRETATION: Short term mortality in patients with malignant biliary obstruction following ERCP was high. 30-day mortality was positively associated with increasing age and co-morbidity, men, deprivation, and earlier year of ERCP and negatively with extrahepatic biliary tree cancer and high volume ERCP providers. FUNDING: Internal funding only.

Performance Measures for Short-Term Cardiac Rehabilitation in Patients of Working Age: Results of the Prospective Observational Multicenter Registry OutCaRe.

OBJECTIVE: To determine immediate performance measures for short-term, multicomponent cardiac rehabilitation (CR) in clinical routine in patients of working age, taking into account cardiovascular risk factors, physical performance, social medicine, and subjective health parameters and to explore the underlying dimensionality. DESIGN: Prospective observational multicenter register study in 12 rehabilitation centers throughout Germany. SETTING: Comprehensive 3-week CR. PARTICIPANTS: Patients (N=1586) ≤65 years of age (mean 53.8±7.3y, 77.1% men) in CR (May 2017-May 2018). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Feasibility, defined by data availability for ≥85% of patients (CR admission and discharge), and modifiability based on pre-post comparison (statistical significance, with P value<.01; standardized effect size≥.35; change by ≥5% points in categorical variables). In addition, latent factors were identified using an exploratory factor analysis (EFA). RESULTS: Based on feasibility and modifiability criteria, smoking behavior, lifestyle change behavior, blood pressure, endurance training load, depression in Patient Health Questionnaire-9 (PHQ-9), the 5-item World Health Organization Well-Being Index (WHO-5), physical and mental health and pain scale of the indicators of rehabilitation status-24 (IRES-24), and self-assessed health prognosis proved to be suitable performance measures. As a result of the EFA, 2 solid factors were identified: (1) subjective mental health including PHQ-9, WHO-5, mental health (IRES-24), mental quality of life, and anxiety and (2) physical health including physical quality of life, physical health and pain scale of IRES-24, and self-assessed occupational prognosis. A third factor represents the blood pressure. CONCLUSIONS: We provide a small set of performance measures, that are essentially based on 3 latent factors (subjective mental health, physical health, blood pressure). These performance measures can represent immediate success of comprehensive CR and be applied easily in clinical practice.

Perceived racism may partially explain the gap in health between Aboriginal and non-Aboriginal Victorians: A cross-sectional population based study.

BACKGROUND: There is a persistent gap in the health of Aboriginal Victorians compared with non-Aboriginal Victorians, where Aboriginal Victorians have poorer health. Currently, the most commonly touted explanation for this gap revolves around health behaviours known as 'lifestyle risk factors'. Yet the gap in health is similarly matched by persistent gaps in social and economic outcomes that reflect past and ongoing discrimination of Aboriginal peoples across Australia. Perceived racism has been implicated as a key determinant of the gap in health between Indigenous and non-Indigenous peoples across the world. We sought to determine the contribution of perceived racism to the gap in health and how this compared with the contribution of lifestyle risk factors and other determinants of health such as socioeconomic status. METHODS: We combined data from 2011, 2012 and 2014 Victorian Population Health Surveys (VPHS) to obtain a sample size of 33,833 Victorian adults, including 387 Aboriginal adults. The VPHS is a population-representative, cross-sectional, computer-assisted telephone interview survey conducted annually. Using logistic regression, poor self-reported health status was the dependent variable and Aboriginal status was the primary independent variable of interest. Secondary independent variables included age, sex, perceived racism, socioeconomic status, and lifestyle risk factors. RESULTS: Aboriginal Victorians were almost twice as likely as non-Aboriginal Victorians to report poor health; OR=1.9 (95% confidence interval; 1.3-2.6). Perceived racism explained 34% of the gap in self-reported health status between Aboriginal and non-Aboriginal Victorians, followed by: smoking (32%), unhealthy bodyweight (20%), socioeconomic status (15%), excessive consumption of alcohol (13%), and abstinence from alcohol consumption (13%). In contrast, physical inactivity made no contribution. Together, perceived racism and smoking explained 58% of the gap, while all secondary independent variables explained 82% of the gap. CONCLUSIONS: Perceived racism may be an independent health risk factor that explains more than a third of the health gap between Aboriginal and non-Aboriginal Victorians; equivalent in strength to smoking. The recognised failure of the Australian government's Closing the Gap strategy may be due in part to the failure to consider other determinants of the health gap beyond the lifestyle risk factors, namely racism, which may act to damage health through multiple pathways at multiple points along the causal chain.

Analytical evaluation of the Radiometer AQT90 FLEX ßhCG assay.

OBJECTIVES: Many hospitals cannot afford an hCG assay on a central lab analyzer and turn to point of care testing (POCT) solutions. The Radiometer AQT90 FLEX is a small benchtop immunoareement between the AQT90 and comparator methods for samples with hCG ssay analyzer for use in the laboratory or at the patient bedside. This study evaluated the analytical performance of the AQT90's ßhCG assay. METHODS: Precision was assessed using whole blood patient samples and two levels of quality control. Linearity was assessed by dilution of a high hCG plasma sample. Carryover and hook effect were assessed using high and low hCG samples. Method comparisons were done against Abbott i-STAT Total ßhCG, Beckman Coulter Total ßhCG (5th IS), and Roche hCG+ß. Sample concentrations ranged from<2 IU/L to 4,973 IU/L. RESULTS: Repeatability and within-laboratory precision passed most manufacturer's claims and allowable error criteria. Linearity was validated from<2 IU/L to 4,741 IU/L. Hook effect was not observed up to 2,446,448 IU/L. Carryover was<4.0 ppm. A linear relationship was observed with i-STAT, Beckman and Roche methods. At>20 IU/L, biases were apparent against all three comparator assays (i-STAT: +20%, Roche: +30%, Beckman: +5 to 15%). At ≤20 IU/L, the acceptability of agreement varied according to TAE specifications. Concordance between AQT90 and comparator assays using 5 IU/L as the medical decision level ranged from 69% to 81%. CONCLUSIONS: Overall, the AQT90 hCG assay performed well and would be suitable for smaller suburban or rural hospitals. Some limitations have been noted and should be kept in mind during clinical testing.