Category: Statistics

J Exp Clin Cancer Res. 2023 Apr 11;42(1):83. doi: 10.1186/s13046-023-02651-y.

ABSTRACT

BACKGROUND: Validated prognostic biomarkers for anti-angiogenic therapy using the anti-VEGF antibody Bevacizumab in ovarian cancer (OC) patients are still an unmet clinical need. The EGFR can contribute to cancer-associated biological mechanisms in OC cells including angiogenesis, but its targeting gave disappointing results with less than 10% of OC patients treated with anti-EGFR compounds showing a positive response, likely due to a non adequate selection and stratification of EGFR-expressing OC patients.

METHODS: EGFR membrane expression was evaluated by immunohistochemistry in a cohort of 310 OC patients from the MITO-16A/MANGO-OV2A trial, designed to identify prognostic biomarkers of survival in patients treated with first line standard chemotherapy plus bevacizumab. Statistical analyses assessed the association between EGFR and clinical prognostic factors and survival outcomes. A single sample Gene Set Enrichment-like and Ingenuity Pathway Analyses were applied to the gene expression profile of 195 OC samples from the same cohort. In an OC in vitro model, biological experiments were performed to assess specific EGFR activation.

RESULTS: Based on EGFR-membrane expression, three OC subgroups of patients were identified being the subgroup with strong and homogeneous EGFR membrane localization, indicative of possible EGFR out/in signalling activation, an independent negative prognostic factor for overall survival of patients treated with an anti-angiogenic agent. This OC subgroup resulted statistically enriched of tumors of histotypes different than high grade serous lacking angiogenic molecular characteristics. At molecular level, among the EGFR-related molecular traits identified to be activated only in this patients’ subgroup the crosstalk between EGFR with other RTKs also emerged. In vitro, we also showed a functional cross-talk between EGFR and AXL RTK; upon AXL silencing, the cells resulted more sensitive to EGFR targeting with erlotinib.

CONCLUSIONS: Strong and homogeneous cell membrane localization of EGFR, associated with specific transcriptional traits, can be considered a prognostic biomarker in OC patients and could be useful for a better OC patients’ stratification and the identification of alternative therapeutic target/s in a personalized therapeutic approach.

PMID:37041632 | DOI:10.1186/s13046-023-02651-y

Infect Dis Poverty. 2023 Apr 11;12(1):35. doi: 10.1186/s40249-023-01085-0.

ABSTRACT

BACKGROUND: Cryptosporidiosis is a zoonotic intestinal infectious disease caused by Cryptosporidium spp., and its transmission is highly influenced by climate factors. In the present study, the potential spatial distribution of Cryptosporidium in China was predicted based on ecological niche models for cryptosporidiosis epidemic risk warning and prevention and control.

METHODS: The applicability of existing Cryptosporidium presence points in ENM analysis was investigated based on data from monitoring sites in 2011-2019. Cryptosporidium occurrence data for China and neighboring countries were extracted and used to construct the ENMs, namely Maxent, Bioclim, Domain, and Garp. Models were evaluated based on Receiver Operating Characteristic curve, Kappa, and True Skill Statistic coefficients. The best model was constructed using Cryptosporidium data and climate variables during 1986‒2010, and used to analyze the effects of climate factors on Cryptosporidium distribution. The climate variables for the period 2011‒2100 were projected to the simulation results to predict the ecological adaptability and potential distribution of Cryptosporidium in future in China.

RESULTS: The Maxent model (AUC = 0.95, maximum Kappa = 0.91, maximum TSS = 1.00) fit better than the other three models and was thus considered the best ENM for predicting Cryptosporidium habitat suitability. The major suitable habitats for human-derived Cryptosporidium in China were located in some high-population density areas, especially in the middle and lower reaches of the Yangtze River, the lower reaches of the Yellow River, and the Huai and the Pearl River Basins (cloglog value of habitat suitability > 0.9). Under future climate change, non-suitable habitats for Cryptosporidium will shrink, while highly suitable habitats will expand significantly (χ² = 76.641, P < 0.01; χ² = 86.836, P < 0.01), and the main changes will likely be concentrated in the northeastern, southwestern, and northwestern regions.

CONCLUSIONS: The Maxent model is applicable in prediction of Cryptosporidium habitat suitability and can achieve excellent simulation results. These results suggest a current high risk of transmission and significant pressure for cryptosporidiosis prevention and control in China. Against a future climate change background, Cryptosporidium may gain more suitable habitats within China. Constructing a national surveillance network could facilitate further elucidation of the epidemiological trends and transmission patterns of cryptosporidiosis, and mitigate the associated epidemic and outbreak risks.

PMID:37041630 | DOI:10.1186/s40249-023-01085-0

BMC Womens Health. 2023 Apr 11;23(1):175. doi: 10.1186/s12905-023-02331-1.

ABSTRACT

BACKGROUND: Pregnant mothers are a risky population group for COVID-19 and pregnant mothers with COVID-19 are at increased risk of hospitalization, intensive-care unit admission, invasive ventilation support, and maternal mortality. Vaccination is an essential tool in stopping the effect of the pandemic on maternal and child health. However, there are only limited studies in Ethiopia on the intention to take the COVID-19 vaccine among pregnant women. Thus, this study aimed to assess intention to take the COVID-19 vaccine and associated factors among pregnant women in Bahir Dar city, Northwest Ethiopia.

METHODS: Facility based cross-sectional study was conducted among 590 pregnant women from 23 May to 07 July 2022. The study participants were selected using a systematic sampling technique. Interviewer administrative questionnaire with epicollect5 application was used to collect the data. Both bi-variable and multivariable binary logistic regression analysis was performed. Statistical significance was defined at a 95% CI with a p-value < 0.05.

RESULT: Overall, 19.8% (95% CI: 16.60-23.06%) of pregnant women intend to take the COVID-19 vaccine. Being urban residence (AOR = 3.40, 95% CI: 1.71-6.78), third trimester of gestational age (AOR = 3.11, 95% CI: 1.61-6.03), multipara (AOR = 2.30, 95% CI: 1.33-3.97), knowledge of COVID-19 vaccine (AOR = 2.33, 95% CI: 1.44-3.77) and having good attitude towards COVID-19 vaccine (AOR = 2.68, 95% CI: 1.65-4.33) were significantly associated with intention to take COVID-19 vaccine.

CONCLUSION: In conclusion, the pregnant women’s intention to take the COVID-19 vaccine in this study area was very low. It was significantly associated with residency, gestational age, parity, knowledge, and attitude toward the vaccine. Therefore, strengthening interventions that improve knowledge and attitude about the COVID-19 vaccine, predominantly among those primipara mothers and mothers from rural residences, may raise the intention to take it.

PMID:37041619 | DOI:10.1186/s12905-023-02331-1

Biol Sex Differ. 2023 Apr 11;14(1):18. doi: 10.1186/s13293-023-00505-y.

NO ABSTRACT

PMID:37041615 | DOI:10.1186/s13293-023-00505-y

Orphanet J Rare Dis. 2023 Apr 11;18(1):79. doi: 10.1186/s13023-023-02693-7.

ABSTRACT

BACKGROUND: Traditional clinical trials require tests and procedures that are administered in centralized clinical research sites, which are beyond the standard of care that patients receive for their rare and chronic diseases. The limited number of rare disease patients scattered around the world makes it particularly challenging to recruit participants and conduct these traditional clinical trials.

MAIN BODY: Participating in clinical research can be burdensome, especially for children, the elderly, physically and cognitively impaired individuals who require transportation and caregiver assistance, or patients who live in remote locations or cannot afford transportation. In recent years, there is an increasing need to consider Decentralized Clinical Trials (DCT) as a participant-centric approach that uses new technologies and innovative procedures for interaction with participants in the comfort of their home.

CONCLUSION: This paper discusses the planning and conduct of DCTs, which can increase the quality of trials with a specific focus on rare diseases.

PMID:37041605 | DOI:10.1186/s13023-023-02693-7

J Cardiothorac Surg. 2023 Apr 11;18(1):136. doi: 10.1186/s13019-023-02263-9.

ABSTRACT

BACKGROUND: Enhanced recovery after surgery guidelines in China recommend early ambulation within 24 h after surgery. The aims of this audit were to investigate the early ambulation of patients with lung cancer under thoracoscopic surgery, and to explore the influence of different ambulation time on postoperative rehabilitation of patients.

METHODS: Using observational study method, observe and record of 226 cases under the thoracoscope surgery early ambulation of patients with lung cancer. Data collected included postoperative bowel movements, chest tube extubation time, length of hospital stay, postoperative pain and the incidence of postoperative complications.

RESULTS: The time of first ambulation was (34.18 ± 17.18) h, the duration was (8.26 ± 4.62) min, and the distance was (54.94 ± 46.06) m. The time of first postoperative defecation, the time of chest tube extubation and the length of hospital stay were significantly shortened in patients who ambulate within 24 h, and the pain score on the third day after surgery was decreased, and the incidence of postoperative complications was reduced, with statistical significance (P < 0.05).

CONCLUSION: Early ambulation within 24 h after thoracoscopic surgery for lung cancer patients can promote the recovery of intestinal function, early removal of chest tube, shorten the length of hospital stay, relieve pain, reduce the incidence of complications, and facilitate the rapid recovery of patients.

PMID:37041603 | DOI:10.1186/s13019-023-02263-9

J Cardiothorac Surg. 2023 Apr 11;18(1):138. doi: 10.1186/s13019-023-02252-y.

ABSTRACT

OBJECTIVES: To evaluate the efficacy of sacubitril/valsartan for the treatment of patients with chronic heart failure (CHF) after cardiac valve surgery (CVS).

METHODS: Data were collected from 259 patients who underwent CVS due to valvular heart disease and were admitted to the hospital with CHF from January 2018 to December 2020. The patients were divided into Group A (treatment with sacubitril/valsartan) and Group B (treatment without sacubitril/valsartan). The duration of treatment and follow-up was 6 months. The two groups’ prior and clinical characteristics, post-treatment data, mortality, and follow-up data were analysed.

RESULTS: The effective rate of Group A was higher than that of Group B (82.56% versus 65.52%, P < 0.05). The left ventricular ejection fraction (LVEF, %) was improved in both groups. The final value minus the initial value was (11.14 ± 10.16 versus 7.15 ± 11.18, P = 0.004). The left ventricular end-diastolic/-systolic diameter (LVEDD/LVESD, mm) in Group A decreased more than in Group B. The final value minus the initial value was (-3.58 ± 9.21 versus – 0.27 ± 14.44, P = 0.026; -4.21 ± 8.15 versus – 1.14 ± 12.12, P = 0.016, respectively). Both groups decreased the N-terminal prohormone of B-type natriuretic peptide (NT-proBNP, pg/ml). The final value minus initial value was [-902.0(-2226.0, -269.5) versus – 535.0(-1738, -7.0), P = 0.029]. The systolic and diastolic blood pressure (SBP/DBP, mmHg) in Group A decreased more than in Group B. The final value minus the initial value was (-13.13 ± 23.98 versus – 1.81 ± 10.89, P < 0.001; -8.28 ± 17.79 versus – 2.37 ± 11.41, P = 0.005, respectively). Liver and renal insufficiency, hyperkalaemia, symptomatic hypotension, angioedema, and acute heart failure had no statistical differences between the two groups.

CONCLUSIONS: Sacubitril/valsartan can effectively improve the cardiac function of patients with CHF after CVS by increasing LVEF and reducing LVEDD, LVESD, NT-proBNP, and BP, with good safety.

PMID:37041595 | DOI:10.1186/s13019-023-02252-y

BMC Psychol. 2023 Apr 11;11(1):108. doi: 10.1186/s40359-023-01130-5.

ABSTRACT

BACKGROUND: The COVID-19 pandemic affected everyone around the globe. Depending on the country, there have been different restrictive epidemiologic measures and also different long-term repercussions. Morbidity and mortality of COVID-19 affected the mental state of every human being. However, social separation and isolation due to the restrictive measures considerably increased this impact. According to the World Health Organization (WHO), anxiety and depression prevalence increased by 25% globally. In this study, we aimed to examine the lasting effects of the COVID-19 pandemic on the general population.

METHODS: A cross-sectional study using an anonymous online-based 45-question online survey was conducted at Comenius University in Bratislava. The questionnaire comprised five general questions and two assessment tools the Zung Self-Rating Anxiety Scale (SAS) and the Zung Self-Rating Depression Scale (SDS). The results of the Self-Rating Scales were statistically examined in association with sex, age, and level of education.

RESULTS: A total of 205 anonymous subjects participated in this study, and no responses were excluded. In the study group, 78 (38.05%) participants were male, and 127 (61.69%) were female. A higher tendency to anxiety was exhibited by female participants (p = 0.012) and the age group under 30 years of age (p = 0.042). The level of education has been identified as a significant factor for changes in mental state, as participants with higher levels of education tended to be in a worse mental state (p = 0.006).

CONCLUSIONS: Summarizing two years of the COVID-19 pandemic, the mental state of people with higher levels of education tended to feel worse, while females and younger adults felt more anxiety.

PMID:37041568 | DOI:10.1186/s40359-023-01130-5

BMC Musculoskelet Disord. 2023 Apr 11;24(1):280. doi: 10.1186/s12891-023-06185-4.

ABSTRACT

BACKGROUND: Patients with rheumatoid arthritis (RA) are prone to muscle atrophy due to inflammatory cytokines and corticosteroid use and immobility due to joint pain and deformity. Although resistance training is effective and safe in reversing muscle atrophy in RA, some patients are unable to perform a conventional high-load exercise program due to disease-related limitations. This study aims to examine the efficacy of individualized exercise therapy on physical function in elderly patients with RA who are at a high risk for sarcopenia.

METHODS: This study is a single-center, parallel-group, two-arm, healthcare provider- and outcome assessor-blinded, superiority randomized controlled trial with a 1:1 allocation ratio. A total of 160 participants with RA between 60 and 85 years of age with a positive screening test for sarcopenia will be included. The intervention group will receive nutritional guidance and a four-month individualized exercise program in addition to the usual treatment. The control group will receive nutritional guidance in addition to the usual care. The primary endpoint will be physical function assessed using the Short Physical Performance Battery (SPPB) at 4 months. The data on outcome measures will be collected at baseline and at the two- and four-month follow-ups. Linear mixed-effects models for repeated measures will be conducted using the modified intention-to-treat analysis population.

DISCUSSION: This study will provide evidence on whether a personalized exercise program can improve physical function and quality of life in elderly patients with RA. Some limitations include limited generalizability due to the single-center study and lack of blinding of the patients to the intervention assignment because of the nature of the exercise. Physical therapists may use this knowledge in their daily practice to improve RA treatment. Tailored exercise may enhance the health outcomes of the RA population and contribute to a reduction in healthcare costs.

TRIAL REGISTRATION: The study protocol was retrospectively registered at the University hospital Medical Information Network-Clinical Trial Repository (UMIN-CTR) (registration number: UMIN000044930, https://www.umin.ac.jp/ctr/index-j.htm ) on January 4, 2022.

PMID:37041556 | DOI:10.1186/s12891-023-06185-4

Radiat Oncol. 2023 Apr 11;18(1):67. doi: 10.1186/s13014-023-02257-w.

ABSTRACT

BACKGROUND: To establish a novel model using radiomics analysis of pre-treatment and post-treatment magnetic resonance (MR) images for prediction of progression-free survival in the patients with stage II-IVA nasopharyngeal carcinoma (NPC) in South China.

METHODS: One hundred and twenty NPC patients who underwent chemoradiotherapy were enrolled (80 in the training cohort and 40 in the validation cohort). Acquiring data and screening features were performed successively. Totally 1133 radiomics features were extracted from the T2-weight images before and after treatment. Least absolute shrinkage and selection operator regression, recursive feature elimination algorithm, random forest, and minimum-redundancy maximum-relevancy (mRMR) method were used for feature selection. Nomogram discrimination and calibration were evaluated. Harrell’s concordance index (C-index) and receiver operating characteristic (ROC) analyses were applied to appraise the prognostic performance of nomograms. Survival curves were plotted using Kaplan-Meier method.

RESULTS: Integrating independent clinical predictors with pre-treatment and post-treatment radiomics signatures which were calculated in conformity with radiomics features, we established a clinical-and-radiomics nomogram by multivariable Cox regression. Nomogram consisting of 14 pre-treatment and 7 post-treatment selected features has been proved to yield a reliable predictive performance in both training and validation groups. The C-index of clinical-and-radiomics nomogram was 0.953 (all P < 0.05), which was higher than that of clinical (0.861) or radiomics nomograms alone (based on pre-treatment statistics: 0.942; based on post-treatment statistics: 0.944). Moreover, we received Rad-score of pre-treatment named RS1 and post-treatment named RS2 and all were used as independent predictors to divide patients into high-risk and low-risk groups. Kaplan-Meier analysis showed that lower RS1 (less than cutoff value, – 1.488) and RS2 (less than cutoff value, – 0.180) were easier to avoid disease progression (all P < 0.01). It showed clinical benefit with decision curve analysis.

CONCLUSIONS: MR-based radiomics measured the burden on primary tumor before treatment and the tumor regression after chemoradiotherapy, and was used to build a model to predict progression-free survival (PFS) in the stage II-IVA NPC patients. It can also help to distinguish high-risk patients from low-risk patients, thus guiding personalized treatment decisions effectively.

PMID:37041545 | DOI:10.1186/s13014-023-02257-w