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Nevin Manimala Statistics

Analysis of characteristics and predictive factors of immune checkpoint inhibitor-related adverse events

Cancer Biol Med. 2021 Jul 14:j.issn.2095-3941.2021.0052. doi: 10.20892/j.issn.2095-3941.2021.0052. Online ahead of print.

ABSTRACT

OBJECTIVE: We aimed to retrospectively analyze the toxicity profiles and predictors of immune-related adverse events (irAEs) as well as the correlation between irAEs and the clinical efficacy of multi-type immune checkpoint inhibitors (ICIs) in patients with advanced pan-cancer in a real-world setting.

METHODS: We retrospectively analyzed data from 105 patients with advanced pan-cancer treated with multi-type ICIs at the First Hospital of Jilin University between January 1, 2016 and August 1, 2020. We used logistic regression analyses to investigate the associations of irAEs with clinical baseline characteristics, blood count parameters, and biochemical indicators during treatment. Receiver operating characteristic curves were used to determine cutoff values for parameters and area under the curve values. KaplanMeier and Cox multivariate regression analyses were performed to estimate the relationships of baseline characteristics and irAEs with progression-free survival (PFS) and overall survival (OS).

RESULTS: A lower relative lymphocyte count (cutoff = 28.5%), higher albumin level (cutoff = 39.05 g/L), and higher absolute eosinophil count (AEC) (cutoff = 0.175 × 109/L) were significantly associated with the occurrence of irAEs, among which a higher AEC (cutoff = 0.205 × 109/L) was strongly associated with skin-related irAEs [odds ratios (ORs) = 0.163, P = 0.004]. Moreover, a higher lactate dehydrogenase level (cutoff = 237.5 U/L) was an independent predictor of irAEs of grade ≥ 3 (OR = 0.083, P = 0.023). In immune cell subgroup analysis, a lower absolute count of CD8+CD28 suppressor T cells (OR = 0.806; 95% confidence interval: 0.643-1.011; P = 0.062), which are regulatory T lymphocytes, was associated with the occurrence of irAEs, although the difference was not statistically significant. Furthermore, a higher percentage of CD19+ B cells was associated with the occurrence of irAEs of grade ≥ 3 (P = 0.02) and grade ≥ 2 (P = 0.051). In addition, patients with any grade of irAE had a significantly high PFS (8.37 vs. 3.77 months, hazard ratios (HR) = 2.02, P = 0.0038) and OS (24.77 vs. 13.83 months, HR = 1.84; P = 0.024).

CONCLUSIONS: This retrospective study reports clinical profile data for irAEs in unselected patients in a real-world setting and explored some parameters that may be potential predictive markers of the occurrence, type, or grade of irAEs in clinical practice. Evidence of a correlation between safety and efficacy may facilitate a complete assessment of the risk-benefit ratio for patients treated with ICIs.

PMID:34259422 | DOI:10.20892/j.issn.2095-3941.2021.0052

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Serological evidence of Bartonellosis in an indigenous community in the Brazilian Legal Amazonia

Zoonoses Public Health. 2021 Jul 14. doi: 10.1111/zph.12881. Online ahead of print.

ABSTRACT

BACKGROUND: Due to immunological susceptibility, close contact with the environment and way of life, indigenous communities are in a highly vulnerable condition to be affected by zoonoses, such as bartonellosis.

METHODS: Seventy three paired serum samples were collected from indigenous people from a region of the Brazilian Legal Amazon, in cohorts carried out in 2014 and 2015, with the performance of serological tests by indirect immunofluorescence to detect anti-Bartonella IgG antibodies. The interviews and laboratory results were double entered in the EpiInfo 7 software, and the data processing was performed in the MiniTab 17 software.

RESULTS: 5.47% of the indigenous people were seroreagent. The female gender was predominant (65.75%), aged between 20 and 39 years old (39.73%) with complete elementary school (42.47%). As for housing, wooden residences predominated (50.68%). Rodents were seen by 46.58% of the interviewees, and 55.88% of them reported that the animal was close to or inside the house. It was identified that each indigenous family, in its majority, had four to six cats, for the function of hunters of rodents.

CONCLUSION: The high concentration of domestic cats, the close contact of indigenous people with wild rodents and the lack of care and poor hygiene of both are aspects that imply the possibility of infection by Bartonella sp. Health surveillance through seroepidemiological studies is essential to find evidence of the circulation of bartonellosis in these populations.

PMID:34259394 | DOI:10.1111/zph.12881

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Effect of Tongdu Tiaoshen acupuncture on serum GABA and CORT levels in patients with chronic insomnia

Zhongguo Zhen Jiu. 2021 Jul 12;41(7):721-4. doi: 10.13703/j.0255-2930.20200704-k0001.

ABSTRACT

OBJECTIVE: To observe the clinical effect of Tongdu Tiaoshen acupuncture on chronic insomnia, and explore its possible mechanism.

METHODS: A total of 60 patients with chronic insomnia were randomly divided into an observation group (30 cases) and a control group (30 cases, 1 case dropped off ). The observation group was treated with Tongdu Tiaoshen acupuncture at Baihui (GV 20), Yintang (GV 29), Shenting (GV 24), etc. once every other day, 3 times a week. The control group was treated with estazolam tablets (1 mg) orally before going to bed every night. The treatments of both groups were required 4 weeks. The Pittsburgh sleep quality index (PSQI) scores, serum gamma-aminobutyric acid (GABA) and cortisol (CORT) levels were observed before and after treatment in the two groups, and the clinical effect was compared.

RESULTS: After treatment, the sleep quality, day dysfunction scores of PSQI in the observation group and the falling asleep time, sleep time, sleep efficiency, sleep disturbance scores and total scores of PSQI in the two groups were lower than before treatment (P<0.01, P<0.05). After treatment, the daytime dysfunction score of PSQI in the observation group was lower than that in the control group (P<0.05). After treatment, the serum GABA levels in the two groups were higher than before treatment (P<0.05), and the serum CORT levels were lower than before treatment (P<0.01). The total effective rate was 90% (27/30) in the observation group and 93.1% (27/29) in the control group, the difference was not statistically significant (P>0.05).

CONCLUSION: Tongdu Tiaoshen acupuncture has the same effect as western medication estazolam tablets in the treatment of patients with chronic insomnia, and has little effect on daytime dysfunction. The mechanism may be related to the increase of serum GABA level and the inhibition of the hyperactivation of hypothalamus-pituitary-adrenal (HPA) axis.

PMID:34259401 | DOI:10.13703/j.0255-2930.20200704-k0001

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Long-term outcomes of patients with chronic inflammatory diseases after percutaneous coronary intervention

Catheter Cardiovasc Interv. 2021 Jul 14. doi: 10.1002/ccd.29870. Online ahead of print.

ABSTRACT

OBJECTIVE: To assess the long-term outcomes of patients with chronic inflammatory diseases who underwent percutaneous coronary intervention (PCI).

METHODS: A Retrospective cohort study of all adult patients who underwent PCI in a large tertiary care center from January 2002 to August 2020.

RESULTS: A total of 12,951 patients underwent PCI during the study period and were included in the cohort. The population of chronic inflammatory diseases includes 247 (1.9%) patients; 70 with inflammatory bowel disease (IBD) and 173 with autoimmune rheumatic diseases (AIRD). The composite endpoint of mortality, acute coronary syndrome (ACS) or admission due to acute heart failure was similar at 30 days and more frequent in the inflammatory disease group (42.8% in AIRD group, 35.7% in the IBD group and 29.6% in the noninflammatory group, p < 0.0001). The adjusted cox regression model found a statistically significant increased risk of the composite primary endpoints of around 40% for patients both with AIRD and IBD. Readmission due to ACS was also increases at 30 days in the AIRD group compared to the noninflammatory group (0.6% vs. 0.1%, p < 0.001) and 1 year (37.6% for the AIRD group, 34.3% in the IBD group and 25.5% in the noninflammatory group (p < 0.0001). Patients with inflammatory diseases were found to have a significantly increased risk congestive heart failure admissions at 1 year in a subgroup analysis of patients with myocardial infarction.

CONCLUSION: Patients with AIRD and IBD are at higher risk for cardiovascular events in long-term follow up once diagnosed with CAD and treated with PCI.

PMID:34259378 | DOI:10.1002/ccd.29870

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Cognitive outcomes at ages seven and nine years in South African children from the children with HIV early antiretroviral (CHER) trial: a longitudinal investigation

J Int AIDS Soc. 2021 Jul;24(7):e25734. doi: 10.1002/jia2.25734.

ABSTRACT

INTRODUCTION: Many children living with HIV (CLWH) display impaired cognition. Although early combination antiretroviral therapy (ART) produces improved cognitive outcomes, more long-term outcome data are needed. After concluding the Children with HIV Early antiRetroviral (CHER) trial in 2011, we investigated cognitive performance, at seven and nine years of age. Participants had been randomized to deferred ART (ART-Def; n = 22); immediate time-limited ART for 40 weeks (ART-40W; n = 30) and immediate time-limited ART for 96 weeks (ART-96W; n = 18). We also recruited HIV-exposed uninfected (CHEU; n = 28) and HIV-unexposed (CHU; n = 35) children.

METHODS: Data were collected between May 2012 and December 2017. Mixed-model repeated-measures ANOVAs assessed differences over time between CLWH (ART-40W, ART-96W and ART-Def) and CHIV- CHEU and CHU between ART-Early (ART-40W and ART-96W), ART-Def, CHEU and CHU; and between ART-40W, ART-96W, ART-Def, CHEU and CHU.

RESULTS: All comparisons found significant effects of Time for most outcome variables (better scores at nine than at seven years; ps < 0.05). The first ANOVAs found that for (a) motor dexterity, CLWH performed worse than CHIV- at seven years (p < 0.001) but improved to equivalence at nine years, (b) visual-spatial processing and problem solving, only CLWH (p < 0.04) showed significant performance improvement over time and (c) working memory and executive function, CLWH performed worse than CHIV- at both seven and nine years (p = 0.03 and 0.04). The second ANOVAs found that for (a) working memory, CHU performed better than ART-Early and CHEU (p < 0.01 and <0.04), and (b) motor dexterity, ART-Def performed worse than ART-Early, CHEU and CHU at seven years (p = 0.02, <0.001 and <0.001 respectively) but improved to equivalence at nine years (ps > 0.17). Similarly, for motor dexterity, ART-Def performed worse than ART-96W, CHEU and CHU at seven years (p < 0.04, <0.001 and <0.001) but improved to equivalence at nine years (ps > 0.20).

CONCLUSIONS: Although neurocognitive developmental trajectories for treatment groups and controls were largely similar (i.e. performance improvements from 7 to 9), all ART-treated children, regardless of treatment arm, remain at risk for cognitive deficits over early school ages. Although the nature of these deficits may change as cognitive development proceeds, there are potential negative consequences for these children’s future learning, reasoning and adaptive functioning.

PMID:34259393 | DOI:10.1002/jia2.25734

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Patterns of digital information and communication technology use among patients at primary health care centres in Colombia: Phase I of the DIADA project

Rev Colomb Psiquiatr (Engl Ed). 2021 Jul 10:S2530-3120(21)00057-6. doi: 10.1016/j.rcpeng.2021.06.003. Online ahead of print.

ABSTRACT

OBJECTIVE: Assess the prevalence and types of digital technology use, as well as the extent to which patients use the internet and mobile devises. Evaluate the socioeconomic characteristics of patients and the possible relation to patterns of technology use in Colombia. Understand the nature of patient technology use in primary care for finding medical information.

METHODS: A survey was applied to adult patients who attended primary health care centers systems in 6 Colombian cities. The survey inquired about demographic characteristics, insurance, access to services, cell phone use, internet access, and the use of such technology to access health-related services and information. Data was collected and managed using REDCap. Summary statistics on each survey item were calculated and the differences between discrete variables were analyzed using chi-square. Multivariate analyses were performed using logistic regression analysis for binary dependent variables.

RESULTS: A total of 1580 patients were surveyed across the six study sites. 93% of the patients reported they have a cell phone. Patients from urban healthcare centers showed a higher use of the Internet on their phone than less urban settings. Around half of the surveyed patients reported Internet use (49.7%). Among Internet users, 65% of participants use the Internet looking for health care information. Around one-third of patients use cellphones to arrange clinic visits. Around 24% of participants answered positively for both Whooley’s questions. Of those who screened positive on the Whooley questions, 43% reported being moderately anxious, 47% reported being very anxious. 51% reported having moderate pain; 52% reported having severe pain.

CONCLUSIONS: The patterns of technology use identified in this study are essential for developing future health interventions based on ICT. The design of ICT clinical interventions must take into account the cellphone payment plans, availability of internet connection, advantages, and disadvantages of messenger services, including SMS as a possible alternative to people who do not have smartphones.

PMID:34257055 | DOI:10.1016/j.rcpeng.2021.06.003

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Clinicopathological characterization of children with dysphagia, family impact and health-related quality of life of their caregivers

An Pediatr (Barc). 2021 Jul 10:S1695-4033(21)00219-8. doi: 10.1016/j.anpedi.2021.06.009. Online ahead of print.

ABSTRACT

INTRODUCTION: Oropharyngeal dysphagia (DOF) without proper evaluation can be underdiagnosed in certain groups of the pediatric population. Meeting the needs of these patients can lead to an overload of their caregivers.

OBJECTIVES: To describe the epidemiological and clinical characteristics of the patients evaluated after starting a monographic DOF clinic (C-DOF) and study whether there are changes at the nutritional level, as well as the burden and impact that caregivers find on quality of life related to health (HRQOL).

MATERIAL AND METHODS: Descriptive observational study of patients evaluated in a C-DOF from its start-up. To evaluate HRQOL, an ad hoc survey adapted from the Swallowing Quality of Life Questionnaire of the adult population was designed.

RESULTS: 103 patients were evaluated, 85.4% presenting some neurological disease. A videofluoroscopic study was performed in 51 patients (49.5%), reporting combined alterations in both the oral and pharyngeal phases in 64.7% of them. There was a directly proportional correlation between the severity of the DOF and the presence of aspirations, as well as with the patient’s motor impairment. Regarding the anthropometric evaluation, there was a trend toward improvement in weight z-score (+0.14 SD), height (+0.17 SD) and BMI (+0.16 SD). Out of 46.2% of the caregivers reported that the DOF problem interfered negatively in the basic activities of daily life. The increase in HRQOL, after the evaluation in the monographic DOF clinic, was statistically significant overall.

CONCLUSIONS: The monographic DOF clinic provided specialized care, impacting positively at the nutritional status of patients, as well as perceived changes in HRQOL, with a probable impact on caregivers.

PMID:34257061 | DOI:10.1016/j.anpedi.2021.06.009

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Racial disparities in bariatric surgery postoperative weight loss and co-morbidity resolution: a systematic review

Surg Obes Relat Dis. 2021 Jun 15:S1550-7289(21)00288-4. doi: 10.1016/j.soard.2021.06.001. Online ahead of print.

ABSTRACT

While bariatric surgery is an accepted treatment for morbid obesity, the impact of race on surgical outcomes remains unclear. This systematic review aims to compare differences in weight loss and co-morbidity outcomes among various races after bariatric surgery. PubMed, Medline, and SCOPUS databases were queried to identify publications that included more than 1 racial group and reported weight loss outcomes after bariatric surgery. A total of 52 studies were included. Non-Hispanic black (NHB) patients comprised between 5.5% and 69.7% and Hispanic patients comprised between 4.7% and 65.3% of the studies’ populations. Definitions of weight loss success differed widely across studies, with percent excess weight loss being the most commonly reported outcome, followed by percent total weight loss and change in body mass index (BMI). Statistical analyses also varied, with most studies adjusting for age, sex, preoperative weight, or BMI. Some studies also adjusted for preoperative co-morbidities, including diabetes mellitus, hypertension, and hyperlipidemia, or socioeconomic status, including income, education, and neighborhood poverty. The majority of studies found less favorable weight loss in NHB compared to Hispanic and non-Hispanic white (NHW), patients while generally no difference was found between Hispanic and NHW patients. The trend also indicates no association between race and resolution of obesity-related co-morbidities. Racial minorities lose less weight than NHW patients after bariatric surgery, although the factors associated with this discrepancy are unclear. The heterogeneity in reporting weight loss success and statistical analyses amongst the literature makes an estimation of effect size difficult. Generally, racial disparity was not seen when examining co-morbidity resolution after surgery. More prospective, robust, long-term studies are needed to understand the impacts of race on bariatric surgery outcomes and ensure successful outcomes for all patients, regardless of race.

PMID:34257030 | DOI:10.1016/j.soard.2021.06.001

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Application of real-time surgical navigation for zygomatic fracture reduction and fixation

J Plast Reconstr Aesthet Surg. 2021 Jun 12:S1748-6815(21)00311-9. doi: 10.1016/j.bjps.2021.05.052. Online ahead of print.

ABSTRACT

BACKGROUND: Inappropriate treatment of zygomatic fractures can reduce esthetic and functional outcomes. The aim of this study was to answer the research question: “Among patients with a unilateral zygomatic fracture, is the use of computer-assisted real-time navigation system during fracture reduction precise and accurate to create postoperative facial symmetry?”

METHODS: Using a retrospective cohort study design, we enrolled a cohort of unilateral zygomatic fractures undergoing open reduction and internal fixation (ORIF) with the aid of the computer-based navigation system at Chang Gung Memorial Hospital, Taiwan, during January 2015 and March 2018. The predictor variable was the comparison before and after surgery. The main outcome variables included (1) two-dimensional (2D) reduction of the displacement at five anatomical landmarks: zygomaticofrontal, inferior orbital rim, zygomaticosphenoidal, zygomaticomaxillary, and zygomaticotemporal lines/buttresses and (2) three-dimensional (3D) differences on distances between zygomatic surface to the porion plane and the midpoint of zygomatic arch (ZA) to the mid-porion (MP) plane. The Wilcoxon signed-rank test was computed to compare between pre- and postoperative data, and a p-value less than 0.05 was considered statistically significant.

RESULTS: The cohort comprised 24 subjects (50% females, 75% left-sided) with a mean age of 30.5 +/- 13.8 years. On 2D analysis, the significant fracture reduction was found: 4.78 vs. 1.22 mm, 1.78 vs. 0.40 mm, 3.50 vs. 0.07 mm, 3.06 vs. 0.55 mm, and 2.55 vs. 0.50 mm at zygomaticomaxillary, zygomaticofrontal, inferior orbital rim, zygomaticosphenoidal, and zygomaticotemporal landmarks. The 3D evaluations revealed the significant reduction of the differences between the left and right zygomatic surface to the porion plane (4.09 ± 2.12 vs. 0.46 ± 0.35 mm) and between the left and right ZA midpoints to the MP plane (4.89 ± 2.59 vs. 0.71 ± 0.44 mm) (p<0.001 for both 2D and 3D analyses).

CONCLUSIONS: The results of this study suggest that the real-time surgical navigation system can effectively guide the ORIF of zygomatic fractures. Future research studies should focus on the learning curve and cost-effectiveness analysis of this technique.

PMID:34257033 | DOI:10.1016/j.bjps.2021.05.052

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Changes in the level of knowledge of diabetes among elderly with diabetes in Slovenia in the period 2011-2020

Prim Care Diabetes. 2021 Jul 10:S1751-9918(21)00118-2. doi: 10.1016/j.pcd.2021.07.001. Online ahead of print.

ABSTRACT

AIMS: To achieve better treatment decisions, type 2 diabetes patients need to be empowered also through knowledge increase. The aim of this study was to evaluate and compare the level of knowledge and overall perceptions of type 2 diabetes within the elderly diabetic patients before and after the National Diabetes Prevention and Care Development Programme 2010-2020.

METHODS: Diabetes knowledge test was used in two cross-sectional studies in 2011 and 2020 where the samples of type 2 diabetes patients 65+ were surveyed. Besides descriptive statistics, non-parametric tests and general linear model were used to compare the level of knowledge.

RESULTS: The comparison reveals that in the last decade the general knowledge about diabetes has not significantly changed (U = 16942, p = 0.809). The average scores in 2011 and 2020 were 7.98 ± 2.41 and 7.96 ± 2.36 respectively. The average level of knowledge has slightly worsened for patients in the age group 80+, while it remained approximately the same in the other three age groups (65-69, 70-74, 75-79).

CONCLUSIONS: Our study has shown that despite the National Diabetes Prevention and Care Development Programme the knowledge of elderly diabetic patients in Slovenia remained at the same level or worsened.

PMID:34257049 | DOI:10.1016/j.pcd.2021.07.001