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Copyright of Industrial Water Treatment is the property of CNOOC Tianjin Chemical Research & Design Institute and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Aims: This study aimed to characterize the prevalence of development defects of enamel (DDE) in patients with cleft based on the cleft phenotype and explore the relationship between surgical procedures and different types of DDE. Material and methods: In this cross-sectional study, 290 standardized orthodontic documentation and medical records from a reference hospital were evaluated, which treated patients with: cleft lip (CL), cleft lip with alveolar bone involvement (CLa), cleft lip and palate (CLP), cleft palate (CP), cleft median (CM), and considering laterality as unilateral or bilateral. DDE was assessed using the Ghanim Index (2015). Information on surgical intervention periods was obtained from medical records. Statistical analyses were performed using prevalence ratio (PR) for DDE comparisons between cleft phenotypes and surgical procedures. Results: The prevalence of DDE was 77.2%. Demarcated hypomineralization was associated with CP and CLP, while hypoplasia was associated with CLa, especially when bilateral. Hypoplasia was also associated with the labial adhesion surgery. Conclusion: Demarcated hypomineralization was the most common DDE in this population, and the cleft phenotype influenced the type of DDE manifested. The lip adhesion surgery increased the chances of hypoplasia manifestation. Clinical relevance: The type of DDE in patients with cleft depends on the cleft phenotype. Understanding this susceptibility enables the multidisciplinary team to monitor dental development, thus allowing early diagnosis and timely referral to the pediatric dentist and better prognoses. [ABSTRACT FROM AUTHOR]

Objectives: This study aimed to report the demographic and clinical characteristics of diabetic macular edema (DME) patients treated with intravitreal injection (IVI) of anti-vascular endothelial growth factors (anti-VEGF) and provide an overview of outcomes during routine clinical practice in Türkiye. Materials and Methods: This retrospective, real-world study included 1,372 eyes (854 patients) treated with a pro re nata protocol by 21 ophthalmologists from 8 tertiary clinics on the Asian side of the Marmara region of Türkiye (MARMASIA Study Group). Five cohort groups were established by collecting the patients' baseline and 3, 6, 12, 24, and 36-month follow-up data, where each subsequent cohort may include the previous. Changes in best-corrected visual acuity (BCVA, approximate ETDRS letters) and central macular thickness (CMT, pm), number of visits and IVI, and rates of anti-VEGF switch and intravitreal dexamethasone implant (IDI) combination were evaluated. Results: The 3, 6, 12, 24, and 36-month cohorts included 1372 (854), 1352 (838), 1185 (722), 972 (581), and 623 (361) eyes (patients), respectively. The mean baseline BCVA and CMT were 51.4±21.4 letters and 482.6±180.3 pm. The mean changes from baseline in BCVA were + 7.6, +9.1, +8.0, +8.6, and +8.4 letters, and in CMT were -115.4, -140.0, -147.9, -167.3, and -215.4 pm at the 3, 6, 12, 24, and 36-month visits (p<0.001 for all). The median cumulative number of anti-VEGF IVI was 3.0, 3.0, 5.0, 7.0, and 9.0, respectively. The overall anti-VEGF switch and IDI combination rates were 18.5% (253/1372 eyes) and 35.0% (480/1372 eyes), respectively. Conclusion: This largest real-life study of DME from Türkiye demonstrated BCVA gains inferior to randomized controlled trials, mainly due to the lower number of IVI. However, with the lower baseline BCVA and higher IDI combination rates in our cohorts, these gains were relatively superior to other real-life study counterparts. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the effect of systemic therapy on health-related quality of life (HRQoL) in patients with advanced esophagogastric cancer in daily clinical practice. This study assessed the HRQoL of patients with esophagogastric cancer during first-line systemic therapy, at disease progression, and after progression in a real-world context. Methods: Patients with advanced esophagogastric cancer (2014–2021) receiving first-line systemic therapy registered in the Prospective Observational Cohort Study of Oesophageal-gastric cancer (POCOP) were included (n = 335). HRQoL was measured with the EORTC QLQ-C30 and QLQ-OG25. Outcomes of mixed-effects models were presented as adjusted mean changes. Results: Results of the mixed-effect models showed the largest significant improvements during systemic therapy for odynophagia (− 18.9, p < 0.001), anxiety (− 18.7, p < 0.001), and dysphagia (− 13.8, p < 0.001) compared to baseline. After progression, global health status (− 6.3, p = 0.002) and cognitive (− 6.2, p = 0.001) and social functioning (− 9.7, p < 0.001) significantly worsened. At and after progression, physical (− 9.0, p < 0.001 and − 8.8, p < 0.001) and role functioning (− 15.2, p = 0.003 and − 14.7, p < 0.001) worsened, respectively. Trouble with taste worsened during systemic therapy (11.5, p < 0.001), at progression (12.0, p = 0.004), and after progression (15.3, p < 0.001). Conclusion: In general, HRQoL outcomes in patients with advanced esophagogastric cancer improved during first-line therapy. Deterioration in outcomes was mainly observed at and after progression. Implications for cancer survivors: Identification of HRQoL aspects is important in shared decision-making and to inform patients on the impact of systemic therapy on their HRQoL. [ABSTRACT FROM AUTHOR]

Background: Although basic laparoscopic hepatectomy (LH) has become the standard procedure for hepatectomy, the safety of advanced LH remains to be clarified, especially in elderly patients. We investigated the safety of advanced LH in elderly Japanese patients., Methods: Elderly patients (≥ 65 years) who underwent advanced LH between 2016 and 2021 were analyzed using a nationwide claims database in Japan. The perioperative outcomes of patients who underwent open hepatectomy (OH group) or LH (LH group) were compared using propensity score matching (PSM). The primary outcome was in-hospital mortality. The E-value method was performed to assess the strength of the outcome point estimates against possible unmeasured confounding factors., Results: Among 5,021 patients, eligible patients were classified into the OH (n = 4,152) and LH (n = 527) groups. The median patient age was 74 years in both groups. Hepatocellular carcinoma and metastatic liver tumors were the major indications for hepatectomy (OH: 52.5% versus 30.6%; LH: 60.7% versus 26.4%). After PSM, in-hospital mortality rates for OH and LH were 1.7 and 0.76%, respectively. The risk ratio was 0.45 (95% confidence interval, 0.16-1.25; E-value = 3.87). Compared with OH, LH was associated with a longer anesthesia time (411 versus 432 min), lower rate of blood product use (red blood concentrate: 33.5% versus 20.3%; fresh frozen plasma: 29.2% versus 17.1%), and shorter hospital stay (13 versus 12 days)., Conclusions: In elderly patients, the safety of advanced LH was similar to that of advanced OH, or might be better in Japan under the current policy of hospital accreditation., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Electronic health records (EHRs) and other real-world data (RWD) are critical to accelerating and scaling care improvement and transformation. To efficiently leverage it for secondary uses, EHR/RWD should be optimally managed and mapped to industry standard concepts (ISCs). Inherent challenges in concept encoding usually result in inefficient and costly workflows and resultant metadata representation structures outside the EHR. Using three related projects to map data to ISCs, we describe the development of standard, repeatable processes for precisely and unambiguously representing EHR data using appropriate ISCs within the EHR platform lifecycle and mappings specific to SNOMED-CT for Demographics, Specialty and Services. Mappings in these 3 areas resulted in ISC mappings of 779 data elements requiring 90 new concept requests to SNOMED-CT and 738 new ISCs mapped into the workflow within an accessible, enterprise-wide EHR resource with supporting processes. [ABSTRACT FROM AUTHOR]

Since the late nineteenth century, millions of Chinese laborers have left their hometowns in search of better lives overseas; many died before returning home. those close to the deceased expatriates strived to repatriate their remains, believing that it would bring peace to their souls. Most repatriated remains were first transported to Tung Wah Hospital until their townsfolks or relatives claimed them. In 2020, Tung Wah published 300 letters it received between 1929 and 1936. With these new materials, this article reveals details in the daily operations of the hospital's coffin home and the motivations of overseas Chinese nationals to repatriate remains. Although some remains were lost or unclaimed for various reasons, Tung Wah Hospital generally fulfilled its mission as a benevolent association and facilitated the repatriation of hundreds of thousands of deceased compatriots. The hospital served as a critical node of the network connecting overseas Chinese nationals to their homelands. [ABSTRACT FROM AUTHOR]

Introduction: Real-world data are limited comparing Asian and White patients with psoriasis using biologic therapy. This study compared the 6-month effectiveness of biologic therapy between Asian and White plaque patients with psoriasis in the CorEvitas Psoriasis Registry. Methods: Analyses included biologic initiations and 6-month follow-up visits from self-identified Asian (n = 293) and White (n = 2314) patients in the USA/Canada (4/2015–4/2020). Outcomes included: Psoriasis Area Severity Index (PASI) 75, disease activity measures [body surface area (BSA) ≤ 1, BSA ≤ 3, PASI90, PASI100, Investigator's Global Assessment (IGA) 0/1], and patient-reported outcomes [Dermatology Life Quality Index (DLQI) 0/1, itch, fatigue, skin pain, EuroQoL visual analog scale (EQ-VAS), patient global assessment, Work Productivity Activity and Impairment (WPAI) domains]. Unadjusted regression models were used to calculate odds ratios (OR) and 95% confidence intervals (CI) for achievement of binary outcomes and difference in mean change in continuous outcomes (β, 95% CI) at 6 months, followed by adjustment for age, sex, body mass index, alcohol, smoking, health insurance, education, comorbidities, scalp psoriasis morphology, psoriatic arthritis, biologic class, previous biologics, and baseline outcome value. Results: Asians had lower proportions of women (32.8% versus 49.1%) and obesity (27.3% versus 54.5%), and higher proportions on Medicaid (19.9% versus 8.8%), graduated college (50.9% versus 40.1%) and never smoked (67.1% versus 44.1%). In unadjusted analyses, Asians had 52% higher odds of achieving PASI75 versus White patients (OR 1.52; 95% CI 1.15, 2.02). After adjustment, the association was attenuated (OR 1.11; 0.81, 1.52). Secondary outcomes experienced similar patterns except for DLQI: Asians had 33% lower odds of achieving DLQI 0/1 in both the unadjusted (OR 0.67; 0.50, 0.90) and adjusted (OR 0.67; 0.49, 0.92) models. Conclusion: Unadjusted differences in biologic therapy effectiveness between Asians compared with White patients were likely explained by differences in demographic, lifestyle, and psoriatic disease characteristics between groups. However, Asians still experienced lesser improvements in skin-related quality of life, even after adjustment. [ABSTRACT FROM AUTHOR]

Background: Despite the demonstrated efficacy and safety of biosimilar filgrastim-aafi (Nivestim™), few studies have compared its use in real-life clinical practice to the originator filgrastim (Neupogen™). Objectives: This study aimed to compare the effectiveness and safety of filgrastim and filgrastim-aafi for the primary prophylaxis of chemotherapy induced-febrile neutropenia in the real-life setting. Patients and methods: A retrospective cohort study included all adult cancer patients at the King Hussein Cancer Centre requiring primary prophylaxis for chemotherapy-induced febrile neutropenia between 2014 and 2016. Two cohorts were selected: patients who received filgrastim and those who received filgrastim-aafi. The primary endpoint was the incidence of febrile neutropenia; the secondary endpoints were the incidence of adverse drug reactions (ADRs), hospital admissions due to febrile neutropenia, and the mean length of hospitalization. Chi-squared tests were performed to evaluate differences between groups. Logistic regression was conducted to adjust for confounding factors. Results: A total of 268 patients were identified, with 88 in the filgrastim cohort and 180 in the filgrastim-aafi cohort; 64%were females. The mean age was 47 (±15) years. The incidence of febrile neutropenia was 21.6% in the filgrastim cohort and 15% in the filgrastim-aafi cohort (P = 0.179). No statistically significant differences were detected in the incidence of hospital admission (P = 0.551) or ADRs (P = 0.623) between the two cohorts. Upon adjusting for the confounding factors, results remained statistically insignificant. Conclusion: Filgrastim and filgrastim-aafi had comparable effectiveness and safety as primary prophylaxis for chemotherapy-induced febrile neutropenia. More extensive prospective studies with additional insight on the cost implications are required. [ABSTRACT FROM AUTHOR]

Data-based clinical decision support systems (CDSSs) can provide personalized support in medical applications. Such systems are expected to play an increasingly important role in the future of healthcare. Within this work, we demonstrate an exemplary CDSS which provides individualized pharmaceutical drug recommendations to physicians and patients. The core of the proposed system is a neighborhood-based collaborative filter (CF) that yields data-based recommendations. CFs are capable of integrating data at different scale levels and a multivariate outcome measure. This publication provides a detailed literature review, a holistic comparison of various implementations of CF algorithms, and a prototypical graphical user interface (GUI). We show that similarity measures, which automatically adapt to attribute weights and data distribution perform best. The illustrated user-friendly prototype is intended to graphically facilitate explainable recommendations and provide additional evidence-based information tailored to a target patient. The proposed solution or elements of it, respectively, may serve as a template for future CDSSs that support physicians to identify the most appropriate therapy and enable a shared decision-making process between physicians and patients. [ABSTRACT FROM AUTHOR]

Background: X-linked hypophosphatemic rickets (XLH) is the most common cause of inherited rickets. Historically, XLH was treated with oral phosphate and calcitriol (conventional treatment). Burosumab, a fibroblast growth factor 23 (FGF-23) monoclonal antibody, was approved by the United States Food and Drug Administration (FDA) in 2018 for XLH treatment. Nevertheless, conventional treatment of XLH continues to be recommended by some specialists due to lack of published experience with burosumab in the clinical setting. We compared laboratory and radiographic changes observed following transition from conventional therapy to burosumab in pediatric XLH patients as part of routine care. Methods: This retrospective single-center study identified and retroactively studied twelve patients aged 1–18 years old with XLH previously treated with conventional therapy and transitioned to burosumab. Laboratory studies and radiographs were obtained routinely as standard of care during two treatment periods: (1) conventional therapy and (2) burosumab treatment. Laboratory values and radiologic rickets severity scores were compared between periods. Results: All laboratory values demonstrated improvement following 1 month of burosumab treatment, findings which were sustained over the 2-year study period. Rickets severity scores and height z-scores also improved with burosumab. There were no serious adverse events with burosumab, and adverse events overall were very infrequent and mild. One patient developed an asymptomatic mild elevation of serum phosphate while taking burosumab resulting in a temporary pause in therapy. Conclusions: Safety and effectiveness of burosumab in treatment of XLH were demonstrated as burosumab yielded statistically significant improvement in laboratory and radiographic markers of rickets and height compared to conventional therapy. A higher resolution version of the Graphical abstract is available as Supplementary information. [ABSTRACT FROM AUTHOR]

There is currently a heightened need for transparency in pharmaceutical sectors. The inclusion of real-world (RW) evidence, in addition to clinical trial evidence, in decision-making processes, was an important step forward toward a more inclusive established value proposition. This advance has introduced new transparency challenges. Increasing transparency is a critical step toward accelerating improvement in type, quality, and access to data, regardless of whether these originate from clinical trials or from RW studies. However, so far, advances in transparency have been relatively restricted to clinical trials, and there remains a lack of similar expectations or standards of transparency concerning the generation and reporting of RW data. This perspective paper aims to highlight the need for transparency concerning RW studies, data, and evidence across health care sectors, to identify areas for improvement, and provide concrete recommendations and practices for the future. Specific issues are discussed from different stakeholder perspectives, culminating in recommended actions, from individual stakeholder perspectives, for improved RW study, data, and evidence transparency. Furthermore, a list of potential guidelines for consideration by stakeholders is proposed. While recommendations from different stakeholder perspectives are made, true transparency in the processes involved in the generation, reporting, and use of RW evidence will require a concerted effort from all stakeholders across health care sectors. [ABSTRACT FROM AUTHOR]

Objective: Propose a process mining-based method for Health Technology Assessment. Methods: Articles dealing with prior studies in Health Technology Assessment using Process Mining were identified. Five research questions were defined to investigate these studies and present important points and desirable characteristics to be addressed in a proposal. The was defined method with five steps and was submitted to a case study for evaluation. Results: The Literature search identified six main characteristics. As a result, the five-step method proposed was applied in the radical prostatectomy surgical procedure between the robot assisted technique and laparoscopy. Conclusion: It was demonstrated in this article the creation of the proposal of an efficient method with its replication for other health technologies, coupled with the good interpretation of the specialists in terms of comprehensibility of the discovered patterns and their correlation with clinical protocols and guidelines. [ABSTRACT FROM AUTHOR]

Purpose: Despite the widespread use of multivitamin/mineral supplements, the effects of multivitamin/mineral on cardiovascular disease (CVD) remain inconclusive. We aimed to prospectively investigate how multivitamin/mineral use is associated with CVD. Methods: This population-based cohort study included 465,278 men and women who participated in the UK Biobank and were free from CVD at baseline. Participants were enrolled between 2006 and 2010 and followed-up until the end of 2018. Data on supplement use including multivitamin/mineral were collected using self-reported questionnaires. Cox proportional hazards models were used to estimate the hazard ratios of CVD events in relation to multivitamin/mineral use. Results: During the follow-up, we identified 25,772 cases of CVD events, 4754 cases of CVD mortality, 18,728 cases of coronary heart disease, 6726 cases of myocardial infarction, and 4561 cases of stroke. The multivariable-adjusted hazard ratios associated with multivitamin/mineral use were 0.96 (95% CI: 0.93, 0.99) for CVD events, 0.92 (0.86, 1.00) for CVD mortality, 0.96 (0.93, 0.99) for coronary heart disease, and 0.92 (0.86, 0.97) for myocardial infarction. Subgroup analysis suggested that multivitamin/mineral use was associated with a significantly lower risk of CVD events in participants aged < 60 years and in former and current smokers (P for interaction ≤ 0.01). Sensitivity analyses showed no substantial change in the results when we excluded participants who developed CVD events during the first 2 years of follow-up. Conclusion: Multivitamin/mineral supplementation was associated with very modest reductions in CVD events. Age and smoking might modify these associations. [ABSTRACT FROM AUTHOR]

Introduction: Real-world pharmacoutilization analysis of biological drugs in psoriatic arthritis (PsA) patients with the aim to evaluate biologic treatment patterns and pharmacoutilization among patients with PsA in Italy. Methods: A retrospective study was conducted using administrative databases of Italian Entities. PsA patients were included and diagnosed by hospitalization and/or an active exemption code. Two analyses were performed: a cross-sectional for treatment patterns in patients enrolled among 2017–2020, and a longitudinal study during 2015 to investigate the pharmacoutilization, in terms of persistence and monthly maintenance dosage of biological/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs). Patients with or without b/tsDMARDs prescriptions before inclusion were defined as bioexperienced or naïve, respectively. An analysis on ixekizumab-treated patients (IXE patients) from the 2017-to study ending was performed. Results: PsA was diagnosed in 24,786 (2017), 27,221 (2018), 28,889 (2019), and 29,292 (2020) patients. Across 2017–2020, 31.1–40.5% of PsA patients were untreated with systemic medications, and 16.4–18.8% were under biological therapies. Among b/tsDMARD-treated patients, decreasing use of TNF-inhibitors (77.6–57.1%) and increasing IL-inhibitors (19.6–33.2%) was found across 2017–2020, respectively. Persistence to TNF-inhibitors and IL inhibitors as first-line ranged, respectively, 74.9–83.0% and 73.0–84.6%; specifically, 73.1–76.9% and 73.0–83.8% among bio-naïve, 83.3–90.0%, and 87.0% among bio-experienced. Among IXE-patients (N = 178), 55.6% were bio-naïve, while 21.9% previously used secukinumab, 12.9% adalimumab, 10.1% etanercept. During a 1-year follow-up, 6.8% of IXE patients switched therapy. Conclusions: This real-world study of PsA pharmacoutilization in Italy showed that more than one-third of patients were systemically untreated, and almost 20% were receiving biological medications. Among biological users, increasing use of IL-inhibitors and a decrease in TNF-inhibitors prescriptions over the years were found. A rather-high extent of persistency in treatment was observed. A focused analysis on IXE patients revealed over half of them to be bio-naïve, while around one-fourth were bio-experienced to IL inhibitors. [ABSTRACT FROM AUTHOR]

Purpose: With higher efficacy of cancer therapies, the numbers and types of side effects experienced by patients have also increased, evidencing a need for brief assessments of side effect bother. The Functional Assessment of Cancer Therapy-General (FACT-G) includes the item "I am bothered by side effects of treatment" (GP5). This study aimed to confirm GP5's validity in a large, diverse, real-world patient sample.Methods: Real-world data were drawn from 10 Adelphi Disease Specific Programmes (DSP™) conducted between 2015 and 2019 in France, Germany, Italy, Spain, the UK and the USA, covering 10 cancer sites. We examined correlations between GP5 responses and varied measures of patient-reported global health and the number of side effects experienced. We explored whether more advanced patients and those with worse Eastern Cooperative Oncology Group Performance Status Rating (ECOG PSR) reported greater side effect bother. Finally, we conducted differential item functioning (DIF) assessment using the Mantel-Haenszel approach.Results: The sample included 6755 advanced cancer patients. GP5 responses were distributed similarly across most cancer sites. A moderate, negative correlation (rpolyserial =  - 0.43) between GP5 responses and global health evidenced convergent validity. Known groups validity was evidenced by dichotomised distributions of GP5, showing expected results between cancer stage 2 vs. 3 and 4 and with ECOG PSR (p < 0.001). Little evidence of DIF was found.Conclusion: GP5 exhibited evidence of validity across cancer sites and countries and appeared to measure the same construct across these countries. GP5 has significant promise as a summary indicator of side effect bother. [ABSTRACT FROM AUTHOR]

Background and aims: Delayed post-polypectomy bleeding (DPPB) is a commonly described adverse event following polypectomy. Prophylactic clipping may prevent DPPB in some patient subgroups. We performed a meta-analysis to assess both the efficacy and real-world effectiveness of prophylactic clipping. Methods: We performed a database search through March 2020 for clinical trials or observational studies assessing prophylactic clipping and DPPB. Pooled risk ratios (RR) were calculated using random effects models. Subgroup, sensitivity, and meta-regression analyses were performed to elucidate clinical or methodological factors associated with effects on outcomes. Results: A total of 2771 citations were screened, with 11 randomized controlled trials (RCTs) and 9 observational studies included, representing 24,670 colonoscopies. DPPB occurred in 2.0% of patients overall. The pooled RR of DPPB was 0.47 (95% CI 0.29–0.77) from RCTs enrolling only patients with polyps ≥ 20 mm. Remaining pooled RCT data did not demonstrate a benefit for clipping. The pooled RR of DPPB was 0.96 (95% CI 0.61–1.51) from observational studies including all polyp sizes. For patients with proximal polyps of any size, the RR was 0.73 (95% CI 0.33–1.62) from RCTs. Meta-regression confirmed that polyp size ≥ 20 mm significantly influenced the effect of clipping on DPPB. Conclusion: Pooled evidence demonstrates a benefit when clipping polyps measuring ≥ 20 mm, especially in the proximal colon. In lower-risk subgroups, prophylactic clipping likely results in little to no difference in DPPB. [ABSTRACT FROM AUTHOR]

Acupuncture is a promising treatment for relieving pain and improving lower back function in clinical practice. However, evidence from randomized clinical trials (RCTs) remains controversial. Most RCTs conclude that acupuncture procedures for chronic low back pain (CLBP) had no significant difference in efficacy and belonged to placebo. We carefully reviewed and analyzed the methodology and implementation of sham acupuncture in RCTs. Controversial evidence of acupuncture for CLBP is only a microcosm of the evaluation methodological limitation of acupuncture. Inappropriate selection of sham acupuncture controls, rigorous RCT research models, and incorrect interpretation of results may contribute to negative evidence. Evaluating and disregarding the holistic efficacy of acupuncture with an explanatory RCT model based on evaluation drugs may be unwise. Moreover, sham acupuncture is often proven to be non-inert, unreasonable, and with low fidelity. Pitfalls of the explanatory RCT model and sham acupuncture design should be avoided. Establishing a new evaluation system that is in line with the clinical characteristics of acupuncture and obtaining high-quality evidence are difficult but promising tasks. [ABSTRACT FROM AUTHOR]

Purpose: Treatment for estrogen receptor positive (ER+), human epidermal receptor 2 negative (HER2−) metastatic breast cancer (MBC) has improved with the approval of CDK 4/6 inhibitors. Clinical trials with the CDK4/6 inhibitor ribociclib, suggest that 35% to 57.5% of the patients require a dose reduction during ribociclib treatment. Data on the possible consequences of dose reduction concerning efficacy is needed. Methods: A retrospective cohort study on patients with ER+ HER2− MBC from three Danish oncology departments. Data on tolerability and progression-free survival were collected from electronic health records. Results: One hundred and twenty-eight patients with ER+ HER2− MBC who initiated ribociclib treatment between 1st of January 2018 to 31st of March 2020 were included in our analysis. Of these patients, 48.4% required one or more dose reductions. Overall median PFS was 19.2 months (CI-95% 14.3-NR). Patients with one or more dose reductions did not have decreased median PFS (19.2 months, CI-95% 14.3-NR compared to 12.2 months, CI-95% 7.3-NR, p = 0.078). Frequency of adverse events were as previously reported, with grade III and IV neutropenia occurring in 45.3% and 7% of patients, respectively. Patients treated with fulvestrant versus an aromatase inhibitor and patients with lymph node involvement at baseline had lower odds of requiring a dose reduction (ORa = 0.30, CI-95% 0.12–0.73 & ORa = 0.41, CI-95% 0.18–0.89, respectively). Conclusion: Our results indicate that dose reduction of ribociclib is safe and do not compromise the efficacy of the treatment. Furthermore, the study supports translation of results from the MONALEESA trials to patients treated in real-world clinical settings. [ABSTRACT FROM AUTHOR]

On the basis of real-world clinical data, the study aimed to explore the effect and mechanisms of the treatment plan of "traditional Chinese medicine (TCM) regulating liver regeneration." A total of 457 patients with HBV-related liver failure were retrospectively collected. The patients were divided into three groups: the modern medicine control group (MMC group), patients treated with routine medical treatment; the control group combining traditional Chinese and Western medicine (CTW), patients treated with routine medical treatment plus the common TCM formula; and the treatment group of "TCM regulating liver regeneration" (RLR), patients treated with both routine medical treatment and the special TCM formula of RLR. After 8 weeks of treatment, the mortality of patients in the RLR group (12.31%) was significantly lower than those in the MMC (50%) and CTW (29.11%) groups. Total bilirubin level significantly decreased and albumin increased in the RLR group when compared with the MMC and CTW groups (P < 0.05). In addition, there were significant differences in the expression of several cytokines related to liver regeneration in the RLR group compared with the MMC group. RLR treatment can decrease jaundice, improve liver function, and significantly reduce the mortality in patients with HBV-related liver failure. The mechanism may be related to the role of RLR treatment in influencing cytokines related to liver regeneration. [ABSTRACT FROM AUTHOR]

Introduction: The aim of this study was to describe the real-world evidence for effectiveness, treatment persistence, and treatment patterns among patients in the community with rheumatoid arthritis treated with the JAK inhibitor tofacitinib. Methods: This was a retrospective, non-interventional cohort study that extracted data for new users of tofacitinib or biologic disease-modifying antirheumatic drugs (bDMARDs) from the Australian Optimizing Patient outcomes in Australian RheumatoLogy (OPAL) dataset between March 2015 and September 2018. Patients were propensity score matched at a 1:2 tofacitinib to bDMARD ratio based on age, sex, and selected baseline treatment combinations. Treatment effectiveness was evaluated using disease status measures. Treatment persistence was calculated and the percentage of patients receiving monotherapy or combination therapy at treatment initiation was evaluated. Results: Data from 2810 patients were extracted and 1950 patients were included in the matched population (1300 bDMARD initiators and 650 tofacitinib initiators). Patients were predominantly aged 55 to 74 years (57.8%) and female (81.2%). After 18 months of treatment, 52.4% and 57.8% of patients had achieved disease activity score (DAS) remission in the bDMARD and tofacitinib groups, respectively. The median treatment persistence for tofacitinib was similar to that for bDMARDs: 34.2 months (95% CI 32.2 to not reached) and 33.8 months (95% CI 28.8 to 40.4), respectively. In the overall population, more patients were prescribed tofacitinib as monotherapy (43.4%) compared with bDMARD monotherapy (33.4%). Conclusions: Tofacitinib demonstrated treatment effectiveness and persistence similar to bDMARDs. Overall, there was a trend for more use of tofacitinib as monotherapy than bDMARDs. Key Points • This study provides real-world evidence regarding effectiveness, treatment persistence, and treatment patterns, among patients with rheumatoid arthritis (RA) in the community being treated with tofacitinib. • The study suggests that tofacitinib is an effective and enduring intervention in RA with tofacitinib persistence and effectiveness comparable to bDMARDs. [ABSTRACT FROM AUTHOR]

Purpose: To conduct a meta-analysis to describe clinical course of pain and disability in adult patients post-lumbar discectomy (PROSPERO: CRD42015020806).Methods: Sensitive topic-based search strategy designed for individual databases was conducted. Patients (> 16 years) following first-time lumbar discectomy for sciatica/radiculopathy with no complications, investigated in inception (point of surgery) prospective cohort studies, were included. Studies including revision surgery or not published in English were excluded. Two reviewers independently searched information sources, assessed eligibility at title/abstract and full-text stages, extracted data, assessed risk of bias (modified QUIPs) and assessed GRADE. Authors were contacted to request raw data where data/variance data were missing. Meta-analyses evaluated outcomes at all available time points using the variance-weighted mean in random-effect meta-analyses. Means and 95% CIs were plotted over time for measurements reported on outcomes of leg pain, back pain and disability.Results: A total of 87 studies (n = 31,034) at risk of bias (49 moderate, 38 high) were included. Clinically relevant improvements immediately following surgery (> MCID) for leg pain (0-10, mean before surgery 7.04, 50 studies, n = 14,910 participants) and disability were identified (0-100, mean before surgery 53.33, 48 studies, n = 15,037). Back pain also improved (0-10, mean before surgery 4.72, 53 studies, n = 14,877). Improvement in all outcomes was maintained (to 7 years). Meta-regression analyses to assess the relationship between outcome data and a priori potential covariates found preoperative back pain and disability predictive for outcome.Conclusion: Moderate-level evidence supports clinically relevant immediate improvement in leg pain and disability following lumbar discectomy with accompanying improvements in back pain. These slides can be retrieved under Electronic Supplementary Material. [ABSTRACT FROM AUTHOR]

There has never been evidence for aneurysmal subarachnoid hemorrhage (aSAH) by endovascular coiling compared to surgical clipping with all grade. The present study and meta-analysis aimed to clarify the in-hospital mortality and poor outcome in the nationwide databases of patients with all grade aSAH between them. The outcome of modified Rankin scale (mRS) at discharge was investigated according to the comprehensive nationwide database in Japan. The propensity score-matched analysis was conducted among patients with aSAH in this database registered between 2010 and 2015. Meta-analysis of studies was conducted based on the nationwide databases published from 2007 to 2018. According to this propensity score-matched analysis, no significant association for poor outcome of mRS > 2 was shown between surgical clipping and endovascular coiling (47.7% vs 48.3%, p = 0.48). However, significantly lower in-hospital mortality was revealed after surgical clipping than endovascular coiling (7.1% vs 12.2%, p < 0.001). Meta-analysis of propensity score-matched analysis in the nationwide database showed no significant association for poor outcome at discharge between them (odds ratio [OR], 1.08; 95% confidence interval [CI], 0.93 to 1.26; p = 0.31). Meta-analysis of propensity score-matched analysis for in-hospital mortality was lower after surgical clipping than after endovascular coiling, however, without significant difference (OR, 0.74; 95% CI, 0.52 to 1.04; p = 0.08). Further prospective randomized controlled study with all grade aSAH should be necessary to validate the in-hospital mortality and poor outcome. [ABSTRACT FROM AUTHOR]

Purpose: The aim of the present study was to evaluate the incidence and explore the risk factors of febrile neutropenia (FN) in patients with esophageal cancer receiving neoadjuvant docetaxel, cisplatin, and 5-fluorouracil (DCF) chemotherapy in real-world settings.Methods: We retrospectively reviewed clinical data of 128 consecutive patients with esophageal cancer. Specifically, these patients underwent neoadjuvant DCF chemotherapy with prophylactic antibiotic administration at our institution between July 2009 and January 2015. Two FN-related endpoints were set as follows: definite FN (dFN) defined as grade 4 neutropenia at the onset of fever and clinically suspected FN (csFN), which included both patients with dFN and patients without grade 4 neutropenia but with deteriorating grade 3 neutropenia at the onset of fever who were clinically diagnosed with FN for which they underwent treatment. The risk factors for dFN and csFN were evaluated based on patients' characteristics.Results: A total of 72 (56.3%) patients developed grade 3 or grade 4 neutropenia and 26 (20.3%) developed csFN including 14 (10.9%) with dFN. Multivariate analysis revealed that older age (OR 3.57, CI 1.27-10.1, P = 0.016) and living alone (OR 5.17, 95% CI 1.26-21.3, P = 0.023) were statistically significant risk factors for csFN development. As to dFN, no statistically significant risk factors were identified.Conclusions: Older age and living alone are significant risk factors for developing FN, and thus, particularly for patients with risk factors for FN, G-CSF should be considered instead of prophylactic antibiotics with careful observation. [ABSTRACT FROM AUTHOR]

Purpose: The aims of this longitudinal model-based meta-analysis (MBMA) were to indirectly compare the time courses of survival probabilities and to identify corresponding potential significant covariates across approved drugs in patients with castration-resistant prostate cancer (CRPC). Methods: A systematic literature review for monotherapy studies in patients with CRPC was conducted up to August 8, 2018. The time courses of progression-free survival (PFS) and overall survival (OS) were fitted with parametric survival models. Covariate analyses were performed to determine the impact of treatment drugs, dosing regimens, and patient characteristics on the survival probabilities. Simulations were carried out to quantify the magnitude of covariate effects. Results: A total of 146 studies including clinical trials and real-world data on longitudinal survival probabilities in 20,712 patients with CRPC were included in our meta-database. The time courses of PFS and OS probabilities were best described by the log-logistic model. There was no significant difference in median OS and PFS between docetaxel, cabazitaxel, abiraterone acetate, and enzalutamide. There was no significant dose-response relationship in PFS or OS for docetaxel at 50 to 120 mg/m2 every 3 weeks (Q3W) and cabazitaxel at 20 to 25 mg/m2 Q3W. Model-based simulations indicated that PFS probability was associated with chemotherapy, Gleason score, and baseline prostate-specific antigen (BLPSA), while OS probability was associated with chemotherapy, Gleason score, visceral metastasis, Eastern Cooperative Oncology Group performance status, and BLPSA. Conclusion: Our modeling and simulation framework can be applied to support indirect comparison, dose selection, and go/no-go decision-making for new agents targeting CRPC. [ABSTRACT FROM AUTHOR]

Purpose of the Review: Spondyloarthritis (SpA) is a group of inflammatory diseases characterized by inflammation in the spine, peripheral joints, and entheses that usually start at the prime of one's life and lead to impaired physical function and reduced quality of life. Ankylosing spondylitis (AS) is prototype of SpA. This article reviews the opportunities and challenges of using mobile health (mHealth) in managing SpA, and report some of our experiences using a mHealth solution for management of SpA patients and performing related research in China. Recent Findings: The recent rapid development of mobile communications and the common use of intelligent electronic devices have led to the increasing application of mHealth for chronic disease management by healthcare providers and patients alike. This is a promising new technology that can help mitigate limitations in time and space for patient management, promote easier communication between patients and their healthcare providers, reduce medical expenses, and optimize medical services. We have developed a smartphone-based mHealth SpA management system (SpAMS) that also helps the patients to monitor, manage, and share information on their disease with their physician at regular intervals. Summary: There is a shift from a paternalistic model of healthcare to more personalized healthcare in which disease management is conducted by the patient together with their healthcare providers. The increasing utility of mHealth is expected to benefit disease management, promote patient–doctor communication, reduce medical expenses, and optimize medical services. [ABSTRACT FROM AUTHOR]

Purpose: Overall survival (OS) has traditionally been the primary endpoint to evaluate drug efficiency in oncology but is often limited by the long observation period and high cost. The aims of this study were to perform a comprehensive meta-analysis at a clinical trial level to investigate the potential surrogate endpoints of OS in patients with castration-resistant prostate cancer (CRPC), and to predict OS based on the relationships associated with the potential surrogate endpoints. Methods: A systematic literature search was conducted in the PubMed database up to August 2018. Correlations between OS and potential surrogate endpoints were determined by linear regression analysis weighted by the square roots of sample size. Simulations were conducted to assess the effect of covariates on the relationships between OS and surrogate endpoints. Results: A total of 233 studies including clinical trials and real-world data were included in our dataset. The correlations between median OS and potential surrogate endpoints for androgen-targeting therapy (R2 = 0.58–0.92) were generally stronger than those for taxane chemotherapy (R2 = 0.37–0.71). Median radiographic progression-free survival (rPFS) showed the strongest correlations with median OS (R2 = 0.94) in patients treated with novel androgen-targeting therapy. Conclusion: The meta-analysis demonstrated that rPFS might serve as a potential surrogate endpoint of OS and offer opportunity to facilitate the interim analyses and decision-making during the early stage of clinical trials for androgen-targeting agents. [ABSTRACT FROM AUTHOR]

The article offers information related to a paradigm shift in treatment and research of mental disorders. Topics discussed include that mental disorders are common and represent a significant and worldwide public health concern; mentions the global burden of disease due to mental illness; and psychotherapy and pharmacotherapy, which are two main available treatments offered to patients with mental disorders around the world.

Purpose: To compare the predictive capacity of the CHA2DS2-VASc and AHEAD scores in predicting acute coronary syndrome (ACS), ischemic stroke (IS), and mortality in patients with heart failure (HF).Methods: A total of 404,635 patients hospitalized for HF between 2000 and 2011 were recruited from a large national database in Taiwan. The predictive value of both scores was evaluated by analysis of the area under the receiver operating characteristic curve (AUROC), and the difference in their discriminative capacity was assessed using the DeLong test.Results: The AUROC for the CHA2DS2-VASc score was significantly higher than that for the AHEAD score in predicting ACS and IS: 0.53 (95% CI = 0.53-0.54) versus 0.51 (95% CI = 0.51-0.52) for ACS, and 0.57 (95% CI = 0.56-0.57) versus 0.52 (95% CI = 0.51-0.52) for IS, respectively (all DeLong tests p < 0.001). By contrast, for mortality risk, the AUROC was significantly lower for the CHA2DS2-VASc score (0.56, 95% CI = 0.55-0.56) than the AHEAD score (0.60, 95% CI = 0.59-0.60; DeLong test p < 0.001).Conclusions: The ability of the CHA2DS2-VASc score to predict macrovascular complications (ACS and IS) in HF patients was higher than that of AHEAD. [ABSTRACT FROM AUTHOR]

This systematic review and meta-analysis aim to evaluate the remission rate of patients with rheumatoid arthritis (RA) in real-world studies and to summarize potential predictors of remission in RA. Studies reporting remission rate in patients with RA were searched from MEDLINE, EMBASE, and Scopus databases. Two reviewers independently assessed all studies according to eligibility criteria and extracted data. Generally, observational studies reporting remission rate in adult (≥ 18 years) patients with RA were included. Quality assessments were performed using the Newcastle-Ottawa Scale. Pooled analyses of remission rate were conducted using a random-effects model and data were analyzed in subgroups to identify potential source of heterogeneity. Sensitivity analyses were performed by serially excluding each study. Potential predictors of remission were summarized. Thirty-one studies with ~ 82,450 RA patients in total were included. Using the DAS28 remission criteria, the pooled 3-, 6-, 12-, and 24-month remission rates were 17.2%, 16.3%, 21.5%, and 23.5%, respectively. Subgroup analyses showed that 11.7% and 13.8% of TNFi inadequate responders reached remission after 6- and 12-month use of non-TNFi biologics. Predictors of remission included male, higher education level, and lower baseline disease activity, while initial use of corticosteroids was negative predictors of remission. Sustained remission was rare regardless of different criteria used. Remission was a reachable target in real-world studies, while attention should also be paid to achieve sustained remission. [ABSTRACT FROM AUTHOR]

Randomized clinical trials often serve the purpose of assessing the efficacy and safety of a compound. By combining real-world evidence and randomization, pragmatic randomized clinical trials (PrCTs) can be used to inform treatment effectiveness and healthcare decisions. PrCTs, referring to studies where several pragmatic elements are used (eligibility, endpoints, follow-up, etc.), pose unique challenges (Loudon et al. in BMJ 350:h2147, 2015). From a literature review, we propose a definition of PrCT and discuss strategies to overcome some PrCT challenges. Use of alternative data collection approaches may lead to uncertainties, and absence of blinding could potentially lead to non-random missing data at study endpoints such that randomization is no longer protected by an intent to treat. Therefore, more complex randomization strategies may be needed to minimize bias. Additional data sources could be used to synthesize information and create a more accurate endpoint definition, which may require tools such as natural language processing. The statistician must become familiar with the challenges and strengths of PrCTs, ranging from design to analysis to interpretation, in order to transform data into evidence (Califf in Clin Trials 13:471-477, 2016). [ABSTRACT FROM AUTHOR]