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Study Design: Modified Delphi study. Objective: The objective of this study was to establish expert consensus on the application of lateral lumbar interbody fusion (LLIF) by using the modified Delphi study. Methods: From June 2019 to March 2020, Members of the Chinese Study Group for Lateral Lumbar Spine Surgery were selected to collect expert feedback using the modified Delphi method where 65 spine surgeons from all over China agreed to participate. Four rounds were performed: 1 face-to-face meeting and 3 subsequent survey rounds. The consensus was achieved with ≥a 70.0% agreement for each question. The recommendation of grade A was defined as ≥90.0% of the agreement for each question. The recommendation of grade B was defined as 80.0-89.9% of the agreement for each question. The recommendation of grade C was defined as 70.0-79.9% of the agreement for each question. Results: A total of 65 experts formed a panelist group, and the number of questionnaires collected was 63, 59, and 62 in the 3 rounds. In total, 5 sections, 71 questions, and 382 items achieved consensus after the Delphi rounds including summary; preoperative evaluation; application at the lumbar spinal stenosis, lumbar disc herniation, lumbar spondylolisthesis, adult degenerative scoliosis, postoperative adjacent segmental degeneration, and revision surgery; complications; and postoperative follow-up evaluation of LLIF. Conclusion: The modified Delphi method was utilized to ascertain an expert consensus from the Chinese Study Group for Lateral Lumbar Spine Surgery to inform clinical decision-making in the application of LLIF. The salient grade A recommendations of the survey are enumerated.

According to Jewish law/ethics, continuous life-sustaining therapy may not be withdrawn after its introduction, unless the patient has improved and no longer has a medical indication for the treatment. We report the case of an 88-year-old Orthodox Jewish patient, on invasive mechanical ventilation, with severe anoxic brain injury after multiple cardiac arrests. Although the patient's son informed the palliative care team that his father did not want to be in pain or to linger in a vegetative state when terminally ill, the mechanical ventilation was keeping him alive with a poor neurological prognosis. Additionally, the patient had previously stated his wish to observe Orthodox Jewish principles regarding end-of-life care. After extensive discussion, the family Rabbi clarified that it would be acceptable to withdraw mechanical ventilation if there were a “reasonable expectation” he would breathe on his own for a “reasonable amount of time.” Thus, if the patient's death were to occur, it would not be an immediate consequence the normal ventilator weaning process. Following intermediation by the hospital Rabbi, the definition of what would be a “reasonable expectation” and “reasonable amount of time” was established by the family Rabbi as “over 50%” and “on the order of hours,” respectively. Following pulmonary consultation, the patient underwent palliative extubation and, 12 hours after the procedure, died comfortably surrounded by the family. In conclusion, the collaborative and interdisciplinary work among the family Rabbi, hospital Rabbi, and the various medical teams allowed the development of a plan that met all of the patient's personal and religious wishes and beliefs.

BackgroundHispanics often have disparities at the end of life. They are more likely to die full code and less likely to have discussions regarding prognosis and do not resuscitate (DNR)/do not intubate (DNI), despite studies showing Hispanic values comfort over the extension of life. Barriers to patient-centered care include language,socioeconomic status and health literacy.ContextWe evaluated the impact of palliative care (PC) consults on the change of code status and hospice referrals, comparing seriously ill Hispanic and non-Hispanic white patients.MethodA retrospective cohort study of all white and Hispanic patients referred to the PC service of a county hospital from 2006 to 2012. We evaluated ethnicity, language, code status at admission and after PC consult, and hospice discharge. Chi-squared tests were used to analyze characteristics among three groups: non-Hispanic white, English-speaking Hispanic, and Spanish-speaking Hispanic patients.ResultsOf 925 patients, 511 (55%) were non-Hispanic white, 208 (23%) were English-speaking Hispanic, and 206 (22%) were Spanish-speaking Hispanic patients. On admission, there was no statistically significant difference in code status among the three groups (57%, 64%, and 59% were full code, respectively, p = 0.5). After PC consults, Spanish-speaking Hispanic patients were more likely to change their code status to DNR/DNI when compared with non-Hispanic white and English-speaking Hispanic patients (44% vs. 32% vs. 28%, p = 0.05). Spanish-speaking Hispanic patients were more likely to be discharged to hospice when compared with English-speaking Hispanics and non-Hispanic whites (33%, 29%, and 23%, respectively, p = 0.04).Significance of resultsSpanish-speaking Hispanic patients were more likely to change from full code to DNR/DNI compared with non-Hispanic white and English-speaking Hispanic patients, despite similar code status preferences on admission. They were also more likely to be discharged to hospice. PC consults may play an important role in helping patients to align their care with their values and may prevent unwanted aggressive interventions at the end of life.

In recent years, with the increasing number of women in advanced maternal age and standardized protocol of prenatal examination in China, more fetuses have been detected with scoliosis caused by hemivertebra (HV). The objective of this study was to obtain the responses of different populations on early detected scoliosis in fetuses caused by spinal hemivertebra through a multi-dimensional survey. A self-administered anonymous web and social media-based multi-dimensional online survey were conducted. Four short questionnaires concerning fetuses with scoliosis secondary to hemivertebra were sent to spine/orthopedic surgeons, obstetricians/ultrasonologists, scoliosis patients, and the non-medical general public separately. Survey items mainly included whether continue the pregnancy, the responses of different populations, whether they have knowledge of HV and what they wanted to know most about HV among the general public group, etc. All the questions were single choice questions, and additional responses could be added if needed. A total of 5586 respondents including 647 spine surgeons, 227 orthopaedic surgeons, 350 obstetricians, 54 ultrasonologists, 246 scoliosis patients and 4062 general public participated in the survey. 41.89% spine surgeons, 25.99% orthopedic surgeons, 6.57% obstetricians, 17.48% scoliosis patients and 19.23% general public chose to continue pregnancy and seek treatment after birth. 4.02% spine surgeons, 7.49% orthopedic surgeons, 3.71% obstetricians, 26.83% scoliosis patients and 14.28% non-medical general public suggested or chose to terminate the pregnancy. 54.10% spine surgeons, 66.52% orthopedic surgeons suggested explain the pros and cons to the parents and let them make their own choices.

Aim: Evaluate real-world patient preferences, experiences and outcomes (health-related quality of life [HRQoL]) from patients with anaplastic lymphoma kinase-positive (ALK+) non-small-cell lung cancer (NSCLC) utilizing the ALKConnect Patient Insight Network. Patients & methods: Demographics, disease history/status/treatment, patient preferences and HRQoL (MD Anderson Symptom Inventory lung cancer module, reported as symptom severity and interference) were evaluated for US adults with ALK+ NSCLC. Results: Among 104 patients (median age: 53.0 years, 67.3% female, 40.0% employed), HRQoL and 3-month delay in disease progression were important treatment attributes. Burdensome symptoms included fatigue and disturbed sleep. Symptoms interfered most with work and day-to-day activity. Higher HRQoL was associated with ALK tyrosine kinase inhibitor (TKI) treatment and employment. Conclusion: ALKConnect demonstrated that disease progression, HRQoL, fatigue/sleep, ALK TKIs and employment matter in ALK+ NSCLC.

Sezary syndrome (SS) is an extremely rare form of cutaneous T-cell lymphoma (incidence 0.01 cases/100,000 person-years) associated with debilitating morbidity and poor overall prognosis.1,2 For patients with relapsed or treatment-refractory SS, traditional therapies are limited and predominantly palliative.1 Multiple prior single-center studies suggest allogeneic hematopoietic stem-cell transplantation (HSCT) with total-skin electron beam (TSEB) may offer durable remission to a subset of these patients.

Background:Dementia is a leading cause of death among US older adults. Little is known about end-of-life care intensity and do-not-resuscitate orders (DNRs) among patients with dementia who die in hospital.Aim:Examine the relationship between dementia, DNR timing, and end-of-life care intensity.Design:Observational cohort study.Setting/Participants:Inpatient electronic health record extraction for 2,566 persons age 65 and older who died in 2 New York City hospitals in the United States from 2015 to 2017.Results:Multivariable logistic regression analyses modeled associations between dementia diagnosis, DNR timing, and 6 end-of-life care outcomes. 31% of subjects had a dementia diagnosis; 23% had a DNR on day of hospital admission. Patients with dementia were 18%-40% less likely to have received 4 of 6 types of intensive care (mechanical ventilation AOR: 0.82, 95%CI: 0.67 -1.00; intensive care unit admission AOR: 0.60, 95%CI: 0.49-0.83). Having a DNR on file was inversely associated with staying in the intensive care unit (AOR: 0.57, 95%CI: 0.47-0.70) and avoiding other intensive care measures. DNR placement later during the hospitalization and not having a DNR were associated with more intensive care compared to having a DNR upon admission.Conclusions:Having dementia and a do-not resuscitate order upon hospital admission are associated with less intensive end-of-life care. Additional research is needed to understand why persons with dementia receive less intensive care. In clinical practice, encouraging advance care planning prior to and at hospital admission may be particularly important for patients wishing to avoid intensive end-of-life care, including patients with dementia.

Background Little is known about real-world treatment and outcomes of patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC). Patients and Methods This retrospective study of the Flatiron Health EHR-derived deidentified database included patients with a lung cancer diagnosis and confirmed advanced NSCLC who received ALK tyrosine kinase inhibitor (TKI) therapy (January 1, 2011, through June 30, 2018). Patient characteristics and treatment patterns were characterized. Real-world progression-free survival (rwPFS) and time to discontinuation were calculated using the Kaplan-Meier method. Results First-line ALK TKI therapy was administered to 581 patients (27.5% had brain metastasis on or prior to initiation) and second-line ALK TKI therapy to 254 patients post crizotinib (45.7% had brain metastasis on or prior to second-line ALK TKI initiation). Crizotinib (84.6%; n = 492) was the most commonly administered first-line ALK TKI therapy. For second-line ALK TKI post crizotinib (n = 254), 49.6% received ceritinib, 41.7% received alectinib, 5.9% received crizotinib retreatment, and 2.8% received brigatinib. Median (95% confidence interval [CI]) rwPFS was 7.47 (6.48–8.32) months for first-line and 7.30 (5.72–8.42) months for second-line ALK TKI. Median (95% CI) rwPFS was significantly longer among first-line ALK TKI patients without than with brain metastasis (8.52 [7.57–10.59] vs. 4.97 [3.75–5.99] months; p Conclusion Median rwPFS in patients with advanced ALK+ NSCLC was

Introduction The treatment landscape for anaplastic lymphoma kinase (ALK)-positive non–small-cell lung cancer (NSCLC) primarily involves ALK-directed tyrosine kinase inhibitors (TKIs). Although therapy with immune checkpoint inhibitors (ICIs) is a treatment option in NSCLC, the efficacy of ICI is inconclusive in ALK-positive NSCLC as a result of limited data. This retrospective real-world study sought to describe the characteristics of ALK-positive NSCLC patients treated with ICI and to assesses treatment outcomes in US oncology practices. Patients and Methods This analysis used the Flatiron Health electronic health record–derived deidentified database and included adult (18 years and older) ALK-positive advanced NSCLC patients with receipt of one or more ICIs after January 1, 2015. Median time to ICI discontinuation and real-world progression-free survival (rwPFS) were estimated by Kaplan-Meier methods. Results Of 83 patients with ALK-positive NSCLC treated with ICIs, 50.6% (n = 42) received ICI without a prior ALK TKI. Median time to ICI discontinuation was 2.17 months (95% confidence interval, 1.41, 3.32). The median rwPFS was 2.34 months (95% confidence interval, 1.55, 3.09); in patients who received an ICI without prior ALK TKI, it was 3.9 months, and in patients who received ICI therapy after an ALK TKI, it was 1.5 months. Conclusions Real-world effectiveness (rwPFS) of ICIs in ALK-positive NSCLC patients, whether provided before or after TKIs, was limited, underscoring the relative lack of efficacy of ICI in this patient population, particularly compared to approved ALK TKIs.

Respiratory symptoms are common in patients living with serious illness, both in cancer and nonmalignant conditions. Common symptoms include dyspnea (breathlessness), cough, malignant pleural effusions, airway secretions, and hemoptysis. Basic management of respiratory symptoms is within the scope of primary palliative care. There are pharmacologic and nonpharmacologic approaches to treating respiratory symptoms. This article provides clinicians with treatment approaches to these burdensome symptoms.

ObjectiveTo characterize the safety and effectiveness during one surgeon’s initial phases of performing a Midline lumbar fusion by freehand technique based on perioperative parameters.MethodsThe first 90 consecutive patients underwent single level MIDLF, utilized a consistent technique, performed by one surgeon were retrospectively studied. A piecewise regression analysis was performed to evaluate the operation duration based on case number, and to estimate the breakpoint. The early learning period and the late steady phase was divided according to the case number of the breakpoint. Perioperative parameters and clinical data of 2 groups were compared then to elucidate if improvement in operative duration was accompanied by better patient prognosis.ResultsThe inflectional asymptote of the surgeon’s learning curve for MIDLF was achieved at the 40th case. The demographics parameters were similar between the early group of 40 patients and the latter 50. Average surgical time, intraoperative blood loss, length of incision, duration of drainage, postoperative drainage and post-operative hospitalization were significantly less in the late cohort (p.05), and lateral cortical breach was observed in 35/360 cases (24 vs.11, P.05). The overall complication incidence decreased alone with the learning curve, and statistical difference was achieved. Furthermore, there was no difference in clinical improvement between the two groups.ConclusionsOur result indicated that technical proficiency in MIDLF was achieved after 40 surgeries. And it is effective to significantly improve the patients’ functional status and relief the pain during one surgeon’s learning process of MIDLF in the treatment of lumbar degenerative disease, even in the initial phase. As the surgeon gains surgical proficiency and familiarity with MIDLF procedure, potential complications could be minimized. Furthermore, our results provided evidence to the excellent performance as an alternative option to traditional pedicle screw fixation.

Retrospective cohort study. Retrospective comparison of radiographic and clinical outcomes between anterior spinal fusion (ASF) and posterior spinal fusion (PSF) in surgical treatment of Lenke 5 curves. ASF and PSF are used for treatment of Lenke 5 curves in patients with adolescent idiopathic scoliosis (AIS). Currently, no consensus exists for optimal surgical treatment of Lenke 5 curves. Patients with Lenke 5 curves treated with either ASF or PSF were prospectively enrolled in a multicenter database and then retrospectively reviewed. Demographic data, perioperative measures, radiographic data, and SRS-22R scores were collected and compared for statistical significance. A total of 149 patients were included in the study; 51 underwent PSF and 98 underwent ASF. There was no difference in demographics between groups. The PSF group was fused one level longer than the ASF group (5.9 levels PSF, 4.6 levels ASF, p < .0001). The PSF group had shorter operative times (223 minutes PSF, 297 minutes ASF; p < .0001) and a higher proportion of patients who received a postoperative blood transfusion (45% vs. 5%, p < .0001). PSF patients had longer hospital stays (6.1d PSF vs. 5d ASF, p = .031). The ASF group had larger preoperative major curve (48.2° ASF, 44.2° PSF; p < .01). Coronal balance, thoracolumbar/lumbar Cobb angle, shoulder height, trunk shift, and overall sagittal balance were not different between groups at two-year follow-up. Curve correction at two-year follow-up was similar between groups (66% ASF vs. 62% PSF). There were no significant differences in clinical outcomes or complication rates between groups. There is no difference in radiographic or clinical outcomes in patients treated with ASF or PSF for Lenke 5 curves. ASF may save a fusion level, but has longer operative time than PSF. Ultimately, the risks and benefits of each approach merit consideration by surgeon and patient. Level II.

The subgroup of young patients with non-small-cell lung cancer (NSCLC) is poorly understood. We retrospectively studied the clinical characteristics, gene mutations, and outcomes of patients with NSCLC (aged ≤ 40 years). Of the 7494 patients with lung cancer diagnosed from February 2001 to October 2016, 252 aged ≤ 40 years showed NSCLC. We divided their cases into non-squamous cell carcinoma and squamous cell carcinoma groups according to their histology results. Of the 252 young NSCLC patients, 173 (69%) patients had stage IIIB or IV, and 196 (78%) had never smoked. The four most common metastases were intrapulmonary lesions, pleura, bone, and brain. Among patients with adenocarcinoma, 29 (40%, n = 73) harbored epidermal growth factor receptor (EGFR) mutations, 25 (34%, n = 74) harbored anaplastic lymphoma kinase (ALK) translations, and 1 (14%, n = 7) harbored ROS proto-oncogene 1 receptor tyrosine kinase (ROS1) translations. The median progression-free survival (PFS) and overall survival (OS) were 3.3 and 27.6 months for patients receiving chemotherapy (n = 65), and 12.1 and 33.6 months for patients receiving EGFR tyrosine kinase inhibitors (TKIs) (n = 13), respectively. Patients receiving crizotinib had a median PFS time of 21.9 months (n = 8). Young patients are associated with an increased likelihood of gene mutations and can receive a better prognosis when patients harboring gene mutations are treated with EGFR-TKIs or ALK inhibitors.

Purpose This study asked whether pregnancy, a risk factor for dry eye disease associated with both chronic, immune-mediated- and autoimmune etiologies, augments development of clusters of coordinately functioning cells (CCFC) that may be precursors to pathological lacrimal gland infiltrates. Methods Lacrimal glands were from six virgin- and six term-pregnant rabbits of the same age and environmental exposure history. Seventy-two immune response-related gene transcripts were assayed by real time RT-PCR. Principal component (PC) analysis identified transcript signatures of CCFC contributing negative ( ⊖ ) or positive ( ⊕ ) PC loadings and determined gland PC projections, which reflect levels of CCFC development. Results Three CCFC were of interest as potential precursors to pathological infiltrates. CCFC 1 ⊖ was suggestive of an ectopic lymphoid structure with resting T cells and B cells. CCFC 1 ⊕ was suggestive of an immune-mediated infiltrate with T H 1 cells and mature, cytotoxic B cells. CCFC 2 ⊖ was suggestive of an ectopic lymphoid structure with activated T cells, mature B cells, germinal center, and plasmacytes. CCFC 4 ⊖ and CCFC 5 ⊖ also included plasmacytes. Pregnancy augmented CCFC 1 ⊖ in some glands; augmented CCFC 1 ⊕ in others; and augmented CCFC 2 ⊖ , CCFC 4 ⊖ , and CCFC 5 ⊖ different combinations. Conclusions Potential precursors of pathological infiltrates form in the lacrimal glands by the time of sexual maturity. Pregnancy augments lacrimal gland plasmacyte populations, and it can augment development of potential precursors to either chronic, immune-mediated infiltrates or autoimmune infiltrates of various phenotypes. Systemic and strictly local, probabilistic phenomena interact with pregnancy to determine which combinatorial phenotypes are favored.

Objective: To describe the current landscape of palliative care (PC) in nursing homes (NHs) in New York State (NYS). Measurements: A statewide survey was completed by 149 respondents who named 61 different NHs as their workplace. Questions were related to presence, type, and composition of PC programs; perceptions of PC; barriers to implementing PC; and qualifying medical conditions. Results: Hospice is less available than palliative or comfort care programs, with three-fourths of NYS NH responded providing a PC program. In general, medical directors and physicians were more similar in perspective about the role/impact of PC compared to nursing and others. There was general agreement about the positive impact and role of PC in the NH. Funding and staffing were recognized as barriers to implementing PC. Conclusion: There is growing penetration of PC programs in NH facilities in NYS, with good perception of the appropriate utilization of PC programs. Financial reimbursement and staffing are barriers to providing PC in the NH and need to be addressed by the health-care system.

Background: Futile or potentially inappropriate care (futile/PIC) for dying inpatients leads to negative outcomes for patients and clinicians. In the setting of rising end-of-life health care costs and increasing physician burnout, it is important to understand the causes of futile/PIC, how it impacts on care and relates to burnout. Objectives: Examine causes of futile/PIC, determine whether clinicians report compensatory or avoidant behaviors as a result of such care and assess whether these behaviors are associated with burnout. Design: Online, cross-sectional questionnaire. Setting/Subjects: Clinicians at two academic hospitals in New York City. Methods: Respondents were asked the frequency with which they observed or provided futile/PIC and whether they demonstrated compensatory or avoidant behaviors as a result. A validated screen was used to assess burnout. Measurements: Descriptive statistics, odds ratios, linear regressions. Results: Surveys were completed by 349 subjects. A majority of clinicians (91.3%) felt they had provided or “possibly” provided futile/PIC in the past six months. The most frequent reason cited for PIC (61.0%) was the insistence of the patient's family. Both witnessing and providing PIC were statistically significantly (p

PURPOSE: The origin of blood in glaucoma-related disc hemorrhages (DH) remains unknown. A prior clinic-based study of primary open-angle glaucoma (POAG)-related DH showed that they had grayscale pixel intensities more similar to blood from retinal macroaneurysms and adjacent retinal arterioles than to blood from retinal vein occlusions or adjacent retinal venules, suggesting an arterial source. Here we assessed the densitometric profile of DH from fundus photographs in the Ocular Hypertension Treatment Study (OHTS). DESIGN: Retrospective cross-sectional study of prospectively collected images. METHODS: Stereo disc photographs of 161 DH events from 83 OHTS participants (mean age (standard deviation (SD)): 65.6 (9.2) years; 46.6% female; 13.0% black race) were imported into ImageJ to measure densitometry differences (adjacent arterioles minus DH (ΔA) or venules minus DH (ΔV)). Their size as percentage of disc area, ratio of length to midpoint width, and location relative to the disc margin were also analyzed. We performed t-tests to compare ΔA and ΔV, analysis of variance to compare ΔA and ΔV across DH recurrent events, and multivariable linear regression to identify determinants of ΔA and ΔV. RESULTS: Mean (SD) ΔA and ΔV were −2.2 (8.7) and −11.4 (9.7) pixel intensity units, respectively (P

Background Critical illness increases the risk for poor mental health outcomes among both patients and their informal caregivers, especially their surrogate decision-makers. Surrogates who must make life-and-death medical decisions on behalf of incapacitated patients may experience additional distress. EMPOWER (Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience) is a novel cognitive-behavioral, acceptance-based intervention delivered in the intensive care unit (ICU) setting to surrogate decision-makers designed to improve both patients’ quality of life and death and dying as well as surrogates’ mental health. Methods Clinician stakeholder and surrogate participant feedback (n = 15), as well as results from an open trial (n = 10), will be used to refine the intervention, which will then be evaluated through a multisite randomized controlled trial (RCT) (n = 60) to examine clinical superiority to usual care. Feasibility, tolerability, and acceptability of the intervention will be evaluated through self-report assessments. Hierarchical linear modeling will be used to adjust for clustering within interventionists to determine the effect of EMPOWER on surrogate differences in the primary outcome, peritraumatic stress. Secondary outcomes will include symptoms of post-traumatic stress disorder, prolonged grief disorder, and experiential avoidance. Exploratory outcomes will include symptoms of anxiety, depression, and decision regret, all measured at 1 and 3 months from post-intervention assessment. Linear regression models will examine the effects of assignment to EMPOWER versus the enhanced usual care group on patient quality of life or quality of death and intensity of care the patient received during the indexed ICU stay assessed at the time of the post-intervention assessment. Participant exit interviews will be conducted at the 3-month assessment time point and will be analyzed using qualitative thematic data analysis methods. Discussion The EMPOWER study is unique in its application of evidence-based psychotherapy targeting peritraumatic stress to improve patient and caregiver outcomes in the setting of critical illness. The experimental intervention will be strengthened through the input of a variety of ICU stakeholders, including behavioral health clinicians, physicians, bereaved informal caregivers, and open trial participants. Results of the RCT will be submitted for publication in a peer-reviewed journal and serve as preliminary data for a larger, multisite RCT grant application. Trial registration ClinicalTrials.gov, NCT03276559. Retrospectively registered on 8 September 2017. Electronic supplementary material The online version of this article (10.1186/s13063-019-3515-0) contains supplementary material, which is available to authorized users.

The COVID-19 pandemic has necessitated rapid vaccine development for the control of the disease. Most vaccinations, including those currently approved for COVID-19 are administered intramuscularly and subcutaneously using hypodermic needles. However, there are several disadvantages including pain and fear of needlesticks, the need for two doses, the need for trained health care professionals for vaccine administration, and barriers to global distribution given the need for cold supply chain. Recently, transdermal techniques have been under investigation for vaccines including COVID-19. Microneedle array technology utilizes multiple microscopic projections from a plate which delivers a vaccine in the form of a patch placed on the skin, allowing for painless antigen delivery with improved immune response. In this review, we discuss challenges of existing vaccines and review the literature on the science behind transdermal vaccines including microneedles, current evidence of application in infectious diseases including COVID-19, and considerations for implementation and global access.

This retrospective longitudinal cohort study aimed to compare treatment patterns, healthcare resource utilization (HRU), and costs in patients with schizophrenia treated with second-generation antipsychotic long-acting injectables (SGA-LAIs): biweekly risperidone LAI versus once-monthly paliperidone palmitate.Patients who initiated risperidone LAI or paliperidone palmitate between 1 July 2007 and 31 December 2012 (index date) were identified from the Truven MarketScan Commercial, Medicare Supplemental, and Medicaid Multi-State insurance databases. Outcomes were assessed 12 months after the index date. Propensity score matching (1:1) based on patients' demographics and comorbidities was conducted. Outcome differences between the two cohorts were evaluated using t-tests for continuous variables, chi-square tests for categorical variables, and Wilcoxon rank-sum tests for count and cost variables. Regression models estimated the difference in medication use and adherence, likelihood of HRU, number of HRU events, and healthcare costs when comparing risperidone LAI versus paliperidone palmitate, while further adjusting for patient characteristics and pre-index HRU.Patient characteristics were well balanced between the two cohorts (n = 499 each). Significantly lower discontinuation rates (36.5% vs. 53.3%; p 0.001) and longer days of LAI coverage (233.6 vs. 131.7 days; p 0.001) were observed in the paliperidone palmitate cohort versus the risperidone LAI cohort, respectively. Patients treated with paliperidone palmitate were 12.5 (95% confidence interval [CI]: 9.0-17.8) and 11.7 (95% CI: 8.0-17.4) times more likely to be adherent based on medication possession ratio and proportion of days covered, respectively (p 0.001). Patients treated with paliperidone palmitate had reduced likelihood of hospitalization (adjusted odds ratio [95% CI]: 0.72 [0.55-0.95]), fewer emergency department (ED) visits (adjusted incidence rate ratio [aIRR]: 0.67 [0.61-0.73]) and reduced length of inpatient stay (aIRR: 0.86 [0.82-0.90]), which resulted in lower monthly inpatient hospitalization costs (-$77.58; p = 0.038) and ED visits (-$9.77; p = 0.021) relative to risperidone LAI.Pharmacy costs were derived from health plan payment in the claims data and do not account for any discounts or rebates. This may have overestimated the branded drug costs in this analysis.These findings highlight the value of once-monthly paliperidone palmitate in the treatment of patients with schizophrenia.

For chronically critically ill elderly patients on mechanical ventilation, prognosis for significant recovery may be minimal. These individuals, or their surrogates, may decide for "palliative extubation." A common prognostic question arises: "How long does she/he have?" This study describes demographics, mortality, time to death, and factors associated with death after palliative extubation.Retrospective 3-year study in community hospital with ethnically diverse elderly population. Chronically critically ill patients followed from palliative extubation to death or survival to discharge.Mortality/survival following palliative extubation, time to death or discharge, factors associated with death.Hundred and forty-eight subjects underwent palliative extubation. Mean age: 78 years, 60% female, ethnically diverse with 46% white, and 54% others. Top diagnostic categories: sepsis (47%) and respiratory failure (22%). After extubation, 114 patients (77%) died in hospital and 34 (23%) were discharged. Of those who died, median time to death 8.9 hours (range, 4 min to 7 d). Mortality proportion was 56% at 24 hours and increased with time. Factors associated with early death: Systolic blood pressure less than 90 (p = 0.002) and Charlson Comorbidity Index that is above 6 or 0 (p = 0.002).Palliative extubation at end of life was an option selected by an ethnically diverse elderly population. Approximately three-fourths of subjects died in hospital, and one-fourth was discharged alive. Over 50% who died did so within 24 hours, making this useful information for counseling and anticipatory planning. Subjects with systolic blood pressure less than 90 and Charlson Comorbidity Index that is very low or very high had higher mortality.

Background Residents of long-term care facilities (LTCFs) are at increased risk for colonization and development of infections with multidrug-resistant organisms. This study was undertaken to determine prevalence of asymptomatic rectal colonization with Clostridium difficile (and proportion of 027/NAP1/BI ribotype) or carbapenem-resistant Enterobacteriaceae (CRE) in an LTCF population. Methods Active surveillance was performed for C difficile and CRE rectal colonization of 301 residents in a 320-bed (80-bed ventilator unit), hospital-affiliated LTCF with retrospective chart review for patient demographics and potential risk factors. Results Over 40% of patients had airway ventilation and received enteral feeding. One-third of these patients had prior C difficile– associated infection (CDI). Asymptomatic rectal colonization with C difficile occurred in 58 patients (19.3%, one-half with NAP1+), CRE occurred in 57 patients (18.9%), and both occurred in 17 patients (5.7%). Recent CDI was significantly associated with increased risk of C difficile ± CRE colonization. Multivariate logistic regression analysis revealed presence of tracheostomy collar to be significant for C difficile colonization, mechanical ventilation to be significant for CRE colonization, and prior CDI to be significant for both C difficile and CRE colonization. Conclusions The strong association of C difficile or CRE colonization with disruption of normal flora by mechanical ventilation, enteral feeds, and prior CDI carries important implications for infection control intervention in this population.

Idiopathic pulmonary fibrosis (IPF) is a rare and fatal restrictive respiratory disease under the idiopathic lung disease (ILD) class. IPF is a form of chronic, progressive fibrosing interstitial pneumonia and has more scarring, less inflammation, and poorer prognosis than most other ILD forms. Exacerbation of IPF is rapid, with unpredictable deterioration of lung function, and is associated with short-term mortality. The American Thoracic Society (ATS) evidence-based guidelines for diagnosis and management of IPF reports that the incidence of acute exacerbations is between 5%-10%. Limited real-world evidence has been identified in the United States that assesses patterns of hospitalization, exacerbation of IPF, and the associated economic burden.To (a) characterize patients newly diagnosed with IPF and (b) examine incidence rates and costs of all-cause hospitalizations, IPF-related hospitalizations, and exacerbations.A retrospective analysis was performed with a national commercial claims database from calendar years 2006 to 2011. Newly diagnosed IPF patients were identified with either ≥ 2 claims for idiopathic fibrosing alveolitis (IFA) or ≥ 1 claim for IFA and ≥ 1 claim for postinflammatory pulmonary fibrosis and a lung biopsy or thoracic high-resolution computed tomography within 90 days of the first claim for IFA (index date). IPF-related hospitalizations and possible IPF exacerbations were defined based on diagnoses recorded on event claims. Frequency, incidence rate, duration of events, and associated costs from the third-party payer's perspective were estimated.Among 1,735 identified IPF patients, 38.6% had at least 1 all-cause hospitalization; 10.8% had IPF-related hospitalizations; 4.6% had suspected IPF exacerbations leading to hospitalization; and 72.1% had suspected IPF exacerbations leading to urgent outpatient visits during the 1-year post-index period. Incident rates for these 4 events were 83 (95% CI = 79-88), 17 (95% CI = 14-19), 7 (95% CI = 6-9), and 277 (95% CI = 269-286) per 100 person-years, respectively. Average costs per event were $13,987 (SD = $41,988), $16,812 (SD = $66,399), $14,731 (SD = $85,468), and $444 (SD = $1,481), respectively.Hospitalizations and possible exacerbations among patients with IPF were costly. Appropriate management of IPF needs to be considered to help slow IPF disease progression.Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) provided funding for this study. Yu and Devercelli are currently salaried employees of BIPI. Wu, Chuang, Wang, Pan, and Benjamin are currently employees of Evidera, which provides consulting and other research services to pharmaceutical, device, government, and nongovernment organizations. In their salaried positions, they work with a variety of companies and organizations and are precluded from receiving payment or honoraria directly from these organizations for services rendered. Evidera received funding from BIPI to conduct the analysis. Coultas was previously a paid consultant of BIPI. The contents do not represent the views of the Department of Veterans Affairs or the U.S. government. This manuscript does not contain clinical studies or patient data. The authors have full control of all primary data, and they agree to allow the journal to review their data if requested. All authors meet the criteria for authorship as recommended by the International Committee of Medical Journal Editors, and they are fully responsible for all content and editorial decisions and were involved at all stages of manuscript development. The manuscript was drafted by Benjamin, Wu, and Yu and revised by Wang, Pan, Yu, Coultas, and Devercelli. The study was designed by Yu, Wu, Chuang, Wang, Benjamin, and Coultas. Statistical analysis was conducted by Wu, Chuang, and Wang. Senior review was provided by Coultas and Devercelli.

The clinical phenotype of patients with congenital dysfibrinogenaemia is highly heterogeneous, from absence of symptoms to mild bleeding, or thrombosis. A few mutations are associated with a specific phenotype, but generally the clinical course is not predictable. We investigated whether fibrin clot properties are correlated with the patient's phenotype and/or genotype. Ex vivo plasma fibrin clot characteristics, including turbidity, fibrinolysis, clot permeability and fibrin fibre density assessed by laser scanner confocal microscopy were investigated in 24 genotyped patients with congenital dysfibrinogenaemia compared to normal pool plasma. Compared to normal pool plasma, the patients were characterised by slower fibrin polymerisation (lag time, 345.10 ? 22.98 vs. 166.00s), thinner fibrin fibres (maximum absorbance, 0.15 ? 0.01 vs. 0.31), prolonged clot lysis time (23.72 ? 0.97 vs. 20.32 min) and larger clot pore size (21.5?10(-9) ? 4.48?10(-9) vs. 7.96?10(-9)cm(2)). Laser scanning confocal microscopy images confirmed disorganised fibrin networks in all patients. Patients with tendency to bleed showed an increased permeability compared to asymptomatic patients (p=0.01) and to patients with a thrombotic history (p=0.02) while patients with thrombotic history had a tendency to have a prolonged clot lysis time. Fibrin clot properties were similar among hotspot mutations. Further studies including a larger number of patients are needed to evaluate whether analysis of permeability and clot lysis time may help to distinguish the clinical phenotype in these patients and to assess differences according to the genotype.

Author(s): La Morgia, Chiara; Ross-Cisneros, Fred N; Koronyo, Yosef; Hannibal, Jens; Gallassi, Roberto; Cantalupo, Gaetano; Sambati, Luisa; Pan, Billy X; Tozer, Kevin R; Barboni, Piero; Provini, Federica; Avanzini, Pietro; Carbonelli, Michele; Pelosi, Annalisa; Chui, Helena; Liguori, Rocco; Baruzzi, Agostino; Koronyo-Hamaoui, Maya; Sadun, Alfredo A; Carelli, Valerio | Abstract: ObjectiveMelanopsin retinal ganglion cells (mRGCs) are photoreceptors driving circadian photoentrainment, and circadian dysfunction characterizes Alzheimer disease (AD). We investigated mRGCs in AD, hypothesizing that they contribute to circadian dysfunction.MethodsWe assessed retinal nerve fiber layer (RNFL) thickness by optical coherence tomography (OCT) in 21 mild-moderate AD patients, and in a subgroup of 16 we evaluated rest-activity circadian rhythm by actigraphy. We studied postmortem mRGCs by immunohistochemistry in retinas, and axons in optic nerve cross-sections of 14 neuropathologically confirmed AD patients. We coimmunostained for retinal amyloid β (Aβ) deposition and melanopsin to locate mRGCs. All AD cohorts were compared with age-matched controls.ResultsWe demonstrated an age-related optic neuropathy in AD by OCT, with a significant reduction of RNFL thickness (p = 0.038), more evident in the superior quadrant (p = 0.006). Axonal loss was confirmed in postmortem AD optic nerves. Abnormal circadian function characterized only a subgroup of AD patients. Sleep efficiency was significantly reduced in AD patients (p = 0.001). We also found a significant loss of mRGCs in postmortem AD retinal specimens (p = 0.003) across all ages and abnormal mRGC dendritic morphology and size (p = 0.003). In flat-mounted AD retinas, Aβ accumulation was remarkably evident inside and around mRGCs.InterpretationWe show variable degrees of rest-activity circadian dysfunction in AD patients. We also demonstrate age-related loss of optic nerve axons and specifically mRGC loss and pathology in postmortem AD retinal specimens, associated with Aβ deposition. These results all support the concept that mRGC degeneration is a contributor to circadian rhythm dysfunction in AD.

Tracheostomies are typically provided to wean patients off the ventilator. However, in many circumstances tracheostomies are placed in patients who are at the end of their life with little hope of meaningful recovery. Palliative care teams decrease utilization of aggressive medical interventions in patients who are at the end of life.The study objective was to determine the impact of a palliative care team on tracheostomy utilization in a community hospital setting.The study was a four-year retrospective analysis of adult patients undergoing elective tracheostomy two years before and after the establishment of a palliative care program. The study in an ethnically diverse community hospital included patients older than 18 years old, with patients undergoing a tracheostomy due to trauma excluded. Before and after comparisons were made of demographics, in-hospital mortality, length of stay, and discharge status of patients undergoing tracheostomy.Seven hundred ninety patients undergoing tracheostomy were identified (n = 406, n = 384 before and after September 10, 2010, respectively). Patients were ethnically diverse (Caucasian 43%, Asian 23%, African American 11%, Hispanic 7%). The number of hospital admissions slightly increased during these two time periods (n = 58,926; n = 60,662, respectively). There were no statistical differences in age (73 versus 72, p = 0.827); gender (n = 218 [54%] versus n = 217 [57%] male, p = 0.426); or race (n = 187 [46%] versus n = 150 [39%] Caucasian, p = 0.073) in the two time periods. Patients who underwent tracheostomy after a palliative care service was established had less incidence of comorbid disease (Charlson Comorbidity Index score [CCIS]: 2 versus 3, p = 0.025); lower inpatient mortality (n = 107 [28%] versus n = 148 [37%], p = 0.009]); greater discharge to home or rehabilitation (n = 262 [68%] versus n = 249 [62%], p = 0.01); and lower rates of palliative weaning from mechanical ventilation (n = 61[16%] versus n = 113 [28%], p0.001).In an ethnically diverse community hospital, the institution of a palliative care program appears to have improved patient selection for tracheostomy with lower rates of inpatient mortality, improved rates of home discharge, and lower rates of palliative weaning from mechanical ventilation.

Background: Futile or potentially inappropriate care (futile/PIC) has been suggested as a factor contributing to clinician well-being; however, little is known about this association. Objective: To determine whether futile/PIC provision is associated with measures of clinician well-being. Design: Cross-sectional, self-administered, online questionnaire. Setting: Two New York City Hospitals. Participants: Attending physicians, residents, nurses, and physician assistants in the fields of internal medicine, surgery, neurology, or intensive care. Exposure(s): Provision of perceived futile/PIC. Measurements: Main outcomes included (1) clinician burnout, measured using the Physician Worklife Study screen; (2) clinician depression, measured using the Patient Health Questionnaire; and (3) intention to quit, measured using questions assessing thoughts of quitting and how seriously it is being considered. Results: Of 1784 clinicians who received surveys, 349 participated. Across all clinicians, 91% reported that they either had or had possibly provided futile/PIC to a patient. Overall, 43.4% of clinicians screened positive for burnout syndrome, 7.8% screened positive for depression, and 35.5% reported thoughts of leaving their job as a result of futile/PIC. The amount of perceived futile/PIC provided was associated with burnout (odds ratio [OR] 3.8 [16-30 patients vs 1-2 patients]; 95% confidence interval [CI]: 1.1-12.8) and having thoughts of quitting (OR, 7.4 [16-30 patients vs 1-2 patients]; 95% CI: 2.0-27), independent of depression, position, department, and the number of dying patients cared for. Conclusions: A large majority of clinicians report providing futile/PIC, and such care is associated with measures of clinician well-being, including burnout and intention to quit.

AIM To explore the role of intravoxel incoherent motion (IVIM) magnetic resonance imaging (MRI) in evaluating DNA mismatch repair (MMR) status of rectal cancers preoperatively. MATERIALS AND METHODS Seventy-six patients with a diagnosis of rectal cancer confirmed at endoscopic biopsy were enrolled prospectively and underwent IVIM MRI before surgery. RESULTS The perfusion fraction (f) values of MMR proteins (MMRP) positive rectal cancers were significantly higher than negative cancers. The f values could differentiate MMRP positive rectal cancers from negative cancers with an area under the curve (AUC) of 0.695. The vascular endothelial growth factor (VEGF) and vascular endothelial growth factor receptor 2 (VEGFR2) expression rates of positive MMRP rectal cancers were significantly higher than negative cancers. CONCLUSION This pilot study indicated that the f value derived from IVIM MRI differed significantly between rectal cancers with different MMRP expression levels, which might be involved with different VEGF and VEGFR2 expression rates.

Background Behcet’s disease (BD) is a complex, inflammatory multisystem disorder. Since the lack of universally recognised pathognomonic laboratory test, the diagnosis relies heavily on clinical findings. Currently, the Monocytes to lymphocytes to ratio (MLR), Neutrophils to Lymphocytes ratio (NLR), Platelets to Lymphocytes ratio (PLR) and Red blood cell Distribution Width(RDW) have been demonstrated as a assessment of disease severity in many rheumatism diseases. Nevertheless, to our knowledge, only a few studies have investigated NLR, PLR, RDW in patients with BD. Objectives The aim of this study is to determine MLR, NLR, PLR and RDW in BD and to investigate their relationships with disease activity. Methods A total of 37 patients with BD fulfilling the criteria of the International Study Group for BD and 37 age and gender-matched healthy controls were enrolled in the study retrospectively. MLR, NLR, PLR, RDW, C-reactive protein(CRP) level and Erythrocyte Sedimentation Rate(ESR) level were evaluated. The correlation between the variables were tested with Pearson correlation. Area Under Curve(AUC) value, sensitivity, specificity, and the optimal cut-off values were determined using Receiver Operating characteristic Curves (ROC). According to the optimal cut off value, BD patients were divided into low-value group ( Results The MLR, NLR, PLR and RDW were (0.37±0.24), (2.91±1.95), (155.09±55.08) and (13.83±1.77) in BD group, while (0.18±0.04), (1.45±0.46), (115.66±28.01) and (13.07±1.19) in control group, the difference was significant (P all Conclusions MLR was elevated in BD patients as compared to control group, having a close relationship with disease activity. References [1] Sariyildiz MA, Yazmalar L, Batmaz I, et al. Serum GDF-15 level inBehcet’s disease: relationships between disease activity and clinicalparameters. Int J Dermatol2016;55:1289–94 [2] Mercan R, et al. The Association Between Neutrophil/Lymphocyte Ratio and Disease Activity in Rheumatoid Arthritis and Ankylosing Spondylitis. J Clin Lab Anal. 2016; 30(5): 597–601. Acknowledgements This study was supported by A talent development fund from Guangdong Second Provincial General Hospital (No. 2014001), Medical Scientific Research Foundation of Guangdong Province(No. A2017551). Disclosure of Interest None declared

Background With the rising epidemic of gout, an increasing number of patients suffer from chronic ulcers associated with tophaceous gout in China, causing poor quality of life and disability. Such ulcers are very difficult conditions to deal with. Vacuum-assisted closure (VAC) has been proved to be effective in treating a variety kinds of wounds such as diabetic foot ulcers. However, its use in chronic ulcers associated with tophaceous gout has been seldom reported. Objectives In the present study, we evaluated the use of VAC in the treatment of chronic ulcers associated with tophaceous gout in comparison to conventional wound care (CWC). Methods We performed a 12 week prospective study that included 13 patients treated with VAC and 14 patients treated with CWC. We collected the clinical outcomes of these patients and data from a satisfaction survey. Chronic ulcers were treated until wound closure, or until the end of 12 weeks. Study will discontinue when the ulcer worsens or remains unchanged by the end of week 4. Results Granulation tissue appeared in 12 (92.31%) patients by the end of week 2 in the VAC group, while it appeared in 6 (42.86%) patients by that time in the CWC group (p=0.013). 100% granulation was achieved in 11 (84.62%) patients by the end of week 8 in the VAC group as compared to 5 (35.71%) patients by that time in the CWC group (p=0.018). By the end of week 12, decreasing in wound size was achieved in 12 (92.31%) patients in the VAC group, while it was achieved in 10 (71.43%) patients in the CWC group (p=0.326). Among them, wound closure was achieved in 9 (69.23%) patients in the VAC group, while it was achieved in 3 (21.43%) patients in the CWC group (p=0.021). None developed local infection in both groups during the treatment. More patients in the VAC group were satisfied with treatment as compared to the CWC group. Conclusions Our preliminary study suggests that VAC therapy is effective and safe in treating chronic ulcers associated with tophaceous gout and appears to be superior to CWC therapy. Large-scale studies are needed to further evaluated the efficacy and safety of the VAC therapy in the treatment of chronic ulcers associated with tophaceous gout. Reference [1] Agarwal J, Ogilvie ML, Lohman R, et al. Vacuum-assisted closure for sternal wounds: a first-line therapeutic management approach. [J]. Plastic & Reconstructive Surgery2015;116(4):1035–1040. Acknowledgements We are grateful to all the participants in our study. Disclosure of Interest None declared

Background PD-L1 immunohistochemistry (IHC) data in China was less reported. We systematically investigated PD-L1 IHC data of Chinese patients generated by Origimed. Methods PD-L1 was stained using IHC on cancer samples from 2060 Chinese patients in Origimed since 2017. Written informed consent was obtained from each patient. IHC staining was performed on FFPE tissue sections using anti-PD-L1 antibody 28-8. Tumor Proportion Score (TPS) was applied on all the samples. We investigated PD-L1 TPS in lung adenocarcinoma (n = 893), lung squamous carcinoma (n = 172), liver cancer (n = 404), esophageal cancer (n = 186), colorectal cancer (n = 166), pancreatic cancer (n = 136) and gastric cancer (n = 103). We then further applied PD-L1 combined positive score (CPS) on the 103 gastric cancer samples. All the slides were reviewed by the same senior pathologist. 95% confidence interval (CI) was obtained by bootstrap. Information entropy (Shannon’s formula) was measured in natural units. Results The highest proportion of PD-L1 TPS > = 1% was observed in lung squamous carcinoma (49%; 95% CI: [43%, 59%]), followed by lung adenocarcinoma (25%; 95% CI: [22%, 28%]), liver cancer (14%; 95% CI: [11%, 18%]), esophageal cancer (12%; 95% CI: [8.1%, 17%]), pancreatic cancer (11%; 95% CI: [5.9%, 16%]), gastric cancer (7%; 95% CI: [1.9%, 12%]) and colorectal cancer (4%; 95% CI: [1.2%, 6.6%]). The proportion of PD-L1 CPS > = 1 for gastric cancer was 17% (95% CI: [9.7%, 24%]). In gastric cancer, information entropy of TPS and CPS was 0.40 and 0.78, respectively. Conclusions The proportion of PD-L1 TPS > = 1% in Chinese lung squamous cell carcinoma (49%) was much higher than that in lung adenocarcinoma (25%). PD-L1 CPS contained more information than TPS in gastric cancer. Thus, we recommend applying CPS to gastric cancer in China. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure X. Pan: Full / Part-time employment: Origimed. Y. Dai: Full / Part-time employment: Origimed. D. Chen: Full / Part-time employment: Origimed. K. Wang: Full / Part-time employment: Origimed. X. Dong: Full / Part-time employment: Origimed. All other authors have declared no conflicts of interest.

The role of serum CA125 and CEA in the prognosis of non-small cell lung cancer (NSCLC) remains controversial, especially in early stage patients, which need further clarification. Thus, in this study we carried out a large scale retrospective analysis of the prognostic value of CA125 and CEA in 645 patients with NSCLC, to explore their predictive value in the NSCLC. Patients who underwent curative surgical resection for NSCLC were from Zhejiang Cancer Hospital of China from 2006 to 2011. Microparticle enzyme immunoassay was used to measure preoperative serum CA125 and CEA. Univariate analyses and a multivariable proportional hazard Cox regression model were applied to assess the prognostic significance of the different covariates. Kaplan-Meier method was used to analyze survival curve. Both CA125 and CEA were correlated with stage, but also CA125 was different by grade, and CEA was related to histology. The Kaplan-Meier survival analysis showed that patients with elevated CA125 or CEA had unfavorable disease progression-free and overall survival time compared to those with normal CA125 or CEA. Furthermore, multivariate Cox analysis revealed that elevated CA125 had significantly higher risk for relapse (HR, 1.76; p=0.001) and death (HR, 1.80; p

Background ESOS (European Scleroderma Observational Study) was a prospective observational study of early diffuse cutaneous systemic sclerosis, recruiting from 50 centres in 19 countries and thus providing a unique opportunity to study parameters of disease progression at regular intervals. Objectives To describe the characteristics of patients with progressive skin thickening and derive prediction models for progression over 12 months. Methods Duration of skin thickening and autoantibody status (anti-topoisomerase-1[anti-Scl-70, TOPO], anti-RNA polymerase III[Pol3], anticentromere[ACA]) were documented. The modified Rodnan skin score (mRSS) was recorded 3-monthly for up to two years after baseline. The main outcome was the progression of mRSS. Progressive patients (“progressors”) had to meet a 5-unit and 25% increase in their mRSS within the first 12 monthsof follow-up. Features of progressors vs. non-progressors were compared using the Fisher or Kruskal-Wallis test (for categorical and continuous variables), as were progression parameters between autoantibody groups. Logistic models were fitted to predict progression and, using ROC curves, were compared based on AUC, accuracy and positive predictive value (PPV). Results 326 patients were recruited, with median disease duration of 11.9 months. During the first 12 months, 66 patients (20.3%) progressed, 227 (69.6%) did not and 33 (10.1%) could not have their status assessed. At baseline, progressors had shorter disease duration than non-progressors: 8.1 months vs. 12.6 months (p=0.001). Progressors started with a lower mRSS, median 19 units vs. 21 for non-progressors (p=0.030). 124 patients were TOPO+, 50 were Pol3+, 20 were ACA+, 2 were TOPO+/ACA+ and 68 had none. Pol3+ patients had a higher mRSS peak (35 units vs. 27 overall[p=0.001]) and did so earlier (median 17.9 months vs. 23.1 months overall[p=0.214]). Using an mRSS 22 cutoff point to predict progression in the ESOS cohort (as suggested in the literature) would yield a PPV of 24.3%, a weak improvement from the observed 20.3% share of progressors. A first model (Model A, with mRSS, duration of skin thickening and their interaction) had an accuracy of 60.9%, AUC of 0.67 and PPV of 33.8%. Figure 1summarizes the prediction rule, with patients under the curved line predicted to progress. By adding a variable for being Pol3+ (Model B), the model reached an accuracy of 71%, AUC of 0.71 and PPV of 41%. Conclusions Patients with shorter disease duration and a lower mRSS have a higher likelihood of being progressors, with a trade-off between the two. Pol3+ patients experience higher mRSS peaks and tend to reach them earlier. Two prediction models for progressive thickening were derived. The advantage of having two is that Model B, while more accurate and useful in identifying high-risk patients in clinical practice, risks being too restrictive for patient selection into trials and may over-represent Pol3+ patients. Disclosure of Interest None declared

The United States population not only is aging, but also becoming more ethnically diverse. Approximately half of elders who take medications find adherence challenging, and cultural diversity is one of the variables that may affect adherence. By better understanding patients' cultural perspectives, senior care pharmacists can more effectively address their medication management needs; failure to recognize these differences may contribute to misunderstanding or miscommunication that may affect treatment. When a patient does not adhere to prescribed medications, explore reasons and feelings. Different ethnic groups have varying communication styles and also seek different degrees of family involvement in diagnosis and treatment. Some mistrust in Western health care, choose to use herbs and nonpharmacologic agents, and have different time orientation that may affect adherence. Senior pharmacists have an active role in screening, evaluation, and counseling elderly, ethnically diverse patients. Applying general trends of cultural values should not be mistaken for stereotyping.

Objectives To evaluate the performance of a massively parallel sequencing (MPS)-based test in detecting fetal sex chromosome aneuploidy (SCA) and to present a comprehensive clinical counseling protocol for SCA-positive patients. Methods This was a retrospective study in a large patient cohort of 5950 singleton pregnancies which underwent MPS-based testing as a prenatal screening test for trisomies 21, 18 and 13, with X and Y chromosomes as secondary findings, in Southwest Hospital in China. MPS-based SCA-positive women were offered the choice of knowing whether their SCA results were positive and those who did commenced a two-stage post-test clinical counseling protocol. In Stage 1, general information about SCA was given, and women were given the option of invasive testing for confirmation of findings; in Stage 2, those who had chosen to undergo invasive testing were informed about the specific SCA affecting their fetus and their management options. Results Thirty-three cases were classified as SCA-positive by MPS-based testing. After Stage 1 of the two-stage post-test clinical counseling session, 33 (100%) of these pregnant women chose to know the screening test results, and 25 (75.76%) underwent an invasive diagnostic procedure and karyotype analysis, in one of whom karyotyping failed. In thirteen cases, karyotyping confirmed the

Recent evidence suggests that inflammatory markers may reflect cerebral disease mechanisms related to dementia. However, whether and how inflammation is associated with cognitive function in older Chinese is unknown. The current study is to analyze the association between high-sensitivity C-reactive protein (CRP), an indicator of chronic inflammation, and domain-specific cognitive function (i.e., mental status, memory, and overall cognition) among older adults aged 65 years and over in China. Data of the study (n=2,438) were selected from the 2015 China Health and Retirement Longitudinal Study (CHARLS) and were analyzed using linear regression models. Results of the study show that for every 1.00 mg/L increase in CRP, the scores of mental status and overall cognition both decreases by 0.03 unit and higher levels of CRP are observed in men than women. The findings might be useful in interpreting the biological mechanisms of dementia and add value in dementia prevention and health promotion for the general older population.