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Safety and efficacy of cataract surgery performed with a low-energy femtosecond laser compared with conventional phacoemulsification in Chinese patients: a randomized clinical trial

Eye Vis (Lond). 2023 Jul 2;10(1):31. doi: 10.1186/s40662-023-00347-0.

ABSTRACT

BACKGROUND: To compare the safety and efficacy of femtosecond laser-assisted cataract surgery (FLACS) performed with the low-energy FEMTO LDV Z8 (Ziemer Ophthalmic Systems AG, Port, Switzerland) laser compared with conventional phacoemulsification (CP) in Chinese patients.

METHODS: This prospective, multicenter, interventional study included 126 patients who were randomized (1:1) to undergo either FLACS or CP followed by intraocular lens (IOL) implantation between January 2019 and April 2020. The primary endpoint included the comparison of the endothelial cell loss (ECL) between the two groups at 3 months. Secondary endpoints included the comparison of cumulative dissipated energy (CDE), change in central corneal thickness (CCT) from baseline, and postoperative uncorrected and corrected distance visual acuities (UDVA and CDVA) in the two groups.

RESULTS: At all postoperative time points, the FLACS group was found to be non-inferior to CP for the mean ECL (- 409.3 versus – 436.9 cells/mm2 at 3 months) and mean CDE (4.1 versus 4.5 percent-seconds). The increase in CCT was significantly lower in the FLACS group compared with the CP group at Day 7 (4.9 versus 9.2 µm; P = 0.04); however, the difference was not statistically significant at 1 and 3 months. Postoperatively, mean UDVA and CDVA were comparable between the two groups. No intraoperative complications occurred.

CONCLUSIONS: Cataract surgery performed with a low-energy femtosecond laser was non-inferior to CP; however, the FLACS group had a statistically significantly lower increase in CCT at Day 7 compared with CP. Trial registration This trial is registered at ClinicalTrials.gov on May 15, 2019, with trial registration number: NCT03953053.

PMID:37393278 | DOI:10.1186/s40662-023-00347-0

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Favorable prognosis of breast cancer brain metastases patients with limited intracranial and extracranial metastatic lesions

Radiat Oncol. 2023 Jul 1;18(1):107. doi: 10.1186/s13014-023-02293-6.

ABSTRACT

BACKGROUND: Breast cancer brain metastases (BCBM) are highly heterogenous with widely differing survival. The prognosis of the oligometastatic breast cancer (BC) patients with brain metastases (BM) has not been well studied. We aimed to investigate the prognosis of BCBM patients with limited intracranial and extracranial metastatic lesions.

METHODS: Four hundred and forty-five BCBM patients treated between 1st January 2008 and 31st December 2018 at our institute were included. Clinical characteristics and treatment information were obtained from patient’s medical records. The updated breast Graded Prognostic Assessment (Breast GPA) was calculated.

RESULTS: The median OS after diagnosis of BM were 15.9 months. Median OS for patients with GPA 0-1.0, 1.5-2, 2.5-3 and 3.5-4 were 6.9, 14.2, 21.8, 42.6 months respectively. The total number of intracranial and extracranial metastatic lesions, in addition to the Breast GPA, salvage local therapy and systemic therapy (anti-HER2 therapy, chemotherapy and endocrine therapy) were demonstrated to be associated with prognosis. One hundred and thirteen patients (25.4%) had 1-5 total metastatic lesions at BM diagnosis. Patients with 1-5 total metastatic lesions had a significantly longer median OS of 24.3 months compared to those with greater than 5 total metastatic lesions with a median OS of 12.2 months (P < 0.001; multivariate HR 0.55, 95% CI, 0.43-0.72). Among the patients with 1-5 metastatic lesions, median OS for GPA 0-1.0 was 9.8 months, compared to 22.8, 28.8 and 71.0 for GPA 1.5-2.0, 2.5-3.0 and 3.5-4.0 respectively, which is much longer than the corresponding patients with greater than 5 total metastatic lesions, with medium OS of 6.8, 11.6, 18.6 and 42.6 months respectively for GPA 0-1.0, 1.5-2.0, 2.5-3.0 and 3.5-4.0.

CONCLUSIONS: The patients with 1-5 total metastatic lesions demonstrated better OS. The prognostic value of the Breast GPA and the survival benefit of salvage local therapy and continuation of systemic therapy after BM were confirmed.

PMID:37393259 | DOI:10.1186/s13014-023-02293-6

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Significant number of Plasmodium vivax mono-infections by PCR misidentified as mixed infections (P. vivax/P. falciparum) by microscopy and rapid diagnostic tests: malaria diagnostic challenges in Ethiopia

Malar J. 2023 Jul 1;22(1):201. doi: 10.1186/s12936-023-04635-x.

ABSTRACT

BACKGROUND: Plasmodium vivax malaria is now recognized as a cause of severe morbidity and mortality, resulting in a substantial negative effect on health especially in endemic countries. Accurate and prompt diagnosis and treatment of P. vivax malaria is vital for the control and elimination of the disease.

METHODS: A cross-sectional study was conducted from February 2021 to September 2022 at five malaria endemic sites in Ethiopia including Aribaminch, Shewarobit, Metehara, Gambella, and Dubti. A total of 365 samples that were diagnosed positive for P. vivax (mono and mixed infection) using RDT, site level microscopists and expert microscopists were selected for PCR. Statistical analyses were performed to calculate the proportions, agreement (k), frequencies, and ranges among different diagnostic methods. Fisher’s exact tests and correlation test were used to detect associations and relationship between different variables.

RESULTS: Of the 365 samples, 324 (88.8%), 37(10.1%), 2 (0.5%), and 2 (0.5%) were P. vivax (mono), P. vivax/Plasmodium falciparum (mixed), P. falciparum (mono) and negative by PCR, respectively. The overall agreement of rapid diagnostic test (RDT), site level microscopy and expert microscopists result with PCR was 90.41% (k: 0.49), 90.96% (k: 0.53), and 80.27% (k: 0.24). The overall prevalence of sexual (gametocyte) stage P. vivax in the study population was 215/361 (59.6%). The majority of these 215 samples (180; 83.7%) had below 1000 parasites/µl, with only four samples (1.9%) had ≥ 5000 parasites/µl. The gametocyte density was found to be weakly positive but statically significant with asexual parasitaemia (r = 0.31; p < 0.001).

CONCLUSION: Both microscopy and RDT showed moderate agreement with PCR in the detection and identification of P. vivax (mono) and P. vivax/P. falciparum (mixed) infections. Therefore, to achieve malaria elimination goals, strengthening routine malaria diagnostic methods by implementing diagnostic tools with a good performance in detecting and accurately identifying malaria species in clinical settings is recommended.

PMID:37393257 | DOI:10.1186/s12936-023-04635-x

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Deep ensemble approach for pathogen classification in large-scale images using patch-based training and hyper-parameter optimization

BMC Bioinformatics. 2023 Jul 1;24(1):273. doi: 10.1186/s12859-023-05398-7.

ABSTRACT

Pathogenic bacteria present a major threat to human health, causing various infections and illnesses, and in some cases, even death. The accurate identification of these bacteria is crucial, but it can be challenging due to the similarities between different species and genera. This is where automated classification using convolutional neural network (CNN) models can help, as it can provide more accurate, authentic, and standardized results.In this study, we aimed to create a larger and balanced dataset by image patching and applied different variations of CNN models, including training from scratch, fine-tuning, and weight adjustment, and data augmentation through random rotation, reflection, and translation. The results showed that the best results were achieved through augmentation and fine-tuning of deep models. We also modified existing architectures, such as InceptionV3 and MobileNetV2, to better capture complex features. The robustness of the proposed ensemble model was evaluated using two data splits (7:2:1 and 6:2:2) to see how performance changed as the training data was increased from 10 to 20%. In both cases, the model exhibited exceptional performance. For the 7:2:1 split, the model achieved an accuracy of 99.91%, F-Score of 98.95%, precision of 98.98%, recall of 98.96%, and MCC of 98.92%. For the 6:2:2 split, the model yielded an accuracy of 99.94%, F-Score of 99.28%, precision of 99.31%, recall of 98.96%, and MCC of 99.26%. This demonstrates that automatic classification using the ensemble model can be a valuable tool for diagnostic staff and microbiologists in accurately identifying pathogenic bacteria, which in turn can help control epidemics and minimize their social and economic impact.

PMID:37393255 | DOI:10.1186/s12859-023-05398-7

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Prolonged usage of fosaprepitant for prevention of delayed chemotherapy-induced nausea and vomiting(CINV) in patients receiving highly emetogenic chemotherapy

BMC Cancer. 2023 Jul 1;23(1):609. doi: 10.1186/s12885-023-11070-3.

ABSTRACT

BACKGROUND: Even though chemotherapy-induced nausea and vomiting (CINV) can be well controlled in the acute phase, the incidence of delayed CINV remains high. In this study, we intend to investigate whether prolonged use of NK-1 receptor antagonist (RA) in addition to 5-HT3 RA and dexamethasone (DEX) was more effective in preventing delayed CINV.

METHODS: This randomised, open-label, controlled study was designed to compare the efficacy and safety of fosaprepitant 150 mg given on days 1,3 (prolonged group) versus on day 1 (regular group) in patients receiving highly emetogenic chemotherapy (HEC). All patients also treated with palonosetron on day 1 and DEX on days 1-3. The primary endpoint was the incidence of delayed nausea and vomiting. The second endpoint was AEs. All the above endpoints were defined according to CTCAE 5.0.

RESULTS: Seventy-seven patients were randomly assigned to prolonged group and seventy-nine to regular group. Prolonged group demonstrated superiority in controlling delayed CINV to regular group, with statistically significant lower incidence of nausea (6.17% vs 12.66%, P = 0.0056), and slightly lower incidence of grade 1 vomiting (1.62% vs 3.80%, P = 0.0953) in the delayed phase. In addition, prolonged use of fosaprepitant was safe. No significant difference was found between the two groups regarding constipation, diarrhea, hiccough, fatigue, palpitation and headache in delayed phase.

CONCLUSIONS: Prolonged use of fosaprepitant can effectively and safely prevent delayed CINV in patients receiving HEC.

PMID:37393241 | DOI:10.1186/s12885-023-11070-3

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Behavioural observation tool for patient involvement and collaboration in emergency care teams (PIC-ET-tool)

BMC Emerg Med. 2023 Jul 1;23(1):74. doi: 10.1186/s12873-023-00841-7.

ABSTRACT

BACKGROUND: Patient participation is advocated in various healthcare settings. Instruments for assessment and feedback have been developed to strengthen clinician-patient interaction. In an emergency department context, such instruments are still missing. The study aimed to develop and test an observation tool for emergency teams’ behaviour regarding patient involvement and collaboration.

METHODS: The development of the behavioural observation tool followed a systematic approach. The tool’s content was based on various data sources, i.e., published literature, interview and observational data, and expert consensus. An international expert panel reviewed the content and the rating scale and rated its importance for patient involvement and collaboration in a Delphi process. The feasibility and reliability of the tool were tested by trained observers using video recordings of simulated emergencies. Intraclass correlation (ICC) and Kappa-statistics were performed to test the tool’s inter-rater reliability.

RESULTS: The PIC-ET tool, a 22-item observation instrument was developed in which patient involvement and collaboration behaviours are rated from ‘no’ to ‘high’ using behavioural anchors. Expert agreement was obtained after three Delphi rounds on the tool content, the behavioural anchors and its importance for patient involvement and collaboration. The content validity was assessed as high, and the tool was found feasible for research. Overall inter-rater reliability was fair (Kappa 0.52).

CONCLUSIONS: A novel tool for assessing emergency teams’ behaviour regarding patient involvement and collaboration is introduced. The tool’s psychometric properties were fair to good. Further validation of the PIC-ET tool is recommended for more robust evidence. Future adaptation to different contexts and areas of use, as well as further validity testing may be of value.

PMID:37393240 | DOI:10.1186/s12873-023-00841-7

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Immunogenicity of adjuvanted versus high-dose inactivated influenza vaccines in older adults: a randomized clinical trial

Immun Ageing. 2023 Jul 1;20(1):30. doi: 10.1186/s12979-023-00355-7.

ABSTRACT

BACKGROUND: Adjuvanted inactivated influenza vaccine (aIIV) and high-dose inactivated influenza vaccine (HD-IIV) are U.S.-licensed for adults aged ≥ 65 years. This study compared serum hemagglutination inhibition (HAI) antibody titers for the A(H3N2) and A(H1N1)pdm09 and B strains after trivalent aIIV3 and trivalent HD-IIV3 in an older adult population.

RESULTS: The immunogenicity population included 342 participants who received aIIV3 and 338 participants who received HD-IIV3. The proportion of participants that seroconverted to A(H3N2) vaccine strains after allV3 (112 participants [32.8%]) was inferior to the proportion of participants that seroconverted after HD-IIV3 (130 participants [38.5%]) at day 29 after vaccination (difference, – 5.8%; 95%CI, – 12.9% to 1.4%). There were no significant differences between the vaccine groups in percent seroconversion to A(H1N1)pdm09 or B vaccine strains, in percent seropositivity for any of the strains, or in post-vaccination GMT for the A(H1N1)pdm09 strain. The GMTs for the post-vaccination A(H3N2) and B strains were higher after HD-IIV than after aIIV3.

CONCLUSIONS: Overall immune responses were similar after aIIV3 and HD-IIV3. For the primary outcome, the aIIV3 seroconversion rate for H3N2 did not meet noninferiority criteria compared with HD-IIV3, but the HD-IIV3 seroconversion rate was not statistically superior to the aIIV3 seroconversion rate.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03183908.

PMID:37393237 | DOI:10.1186/s12979-023-00355-7

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Changes in the mean incidence and variance of orthopedic diseases before and during the COVID-19 pandemic in Korea: a retrospective study

BMC Musculoskelet Disord. 2023 Jul 1;24(1):540. doi: 10.1186/s12891-023-06634-0.

ABSTRACT

BACKGROUND: During the coronavirus disease (COVID-19) pandemic, the amount of moderate- to high-intensity physical activity significantly decreased. Therefore, the epidemiology of musculoskeletal diseases could possibly have changed. We assessed changes in the incidence of and variance in non-traumatic orthopedic diseases before and after the COVID-19 pandemic in Korea.

METHODS: This study included data from the Korea National Health Insurance Service, which covers the entire Korean population (approximately 50 million), from January 2018 to June 2021. Using International Classification of Diseases, Tenth Revision codes, 12 common orthopedic diseases were evaluated, including cervical disc disorders, lumbar disc disorders, forward head posture, myofascial pain syndrome, carpal tunnel syndrome, tennis elbow, frozen shoulder, rheumatoid arthritis, gout, hip fracture, distal radius fracture, and spine fracture diseases. “Pre-COVID-19” was the period until February 2020, and “COVID-19 pandemic period” was the period starting March 2020. Differences in the mean incidence and variance of diseases before and during the COVID-19 pandemic were compared.

RESULTS: In most cases, the incidence of orthopedic diseases decreased at the beginning of the pandemic and then increased thereafter. Among the 12 diseases, the incidence of three diseases showed a statistically significant change. The incidence of myofascial pain syndrome (P < 0.001) was lower during the COVID-19 pandemic than during the pre-COVID-19 period. The incidences of frozen shoulder (P < 0.001) and gout (P = 0.043) were higher during the COVID-19 pandemic than during the pre-COVID-19 period. However, no statistical difference in disease variations was observed between the two periods.

CONCLUSIONS: The incidence of orthopedic diseases varied during the COVID-19 pandemic among the Korean population. Although the incidence of myofascial pain syndrome was lower, that of frozen shoulder and gout was higher during the COVID-19 pandemic than during the pre-COVID-19 period. No disease variations during the COVID-19 pandemic were found.

PMID:37393227 | DOI:10.1186/s12891-023-06634-0

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COVID-19 pandemic has disrupted the continuity of care for chronic patients: evidence from a cross-sectional retrospective study in a developing country

BMC Prim Care. 2023 Jul 1;24(1):137. doi: 10.1186/s12875-023-02086-6.

ABSTRACT

BACKGROUND: Any disruption in continuity of care for patients with chronic conditions can lead to poor outcomes for the patients as well as great damage for the community and the health system. This study aims to determine the continuity of care for patients with chronic conditions such as hypertension and diabetes during COVID-19 pandemic.

METHODS: Through a cross-sectional retrospective study, data registered in six health centers in Yazd, Iran were analyzed. Data included the number of patients with chronic conditions (hypertension and diabetes) and average daily admission during a year before COVID-19 pandemic and the similar period after COVID-19 outbreak. The experience of continuity of care was assessed applying a validated questionnaire from a sample of 198 patients. Data analysis was done using SPSS version 25. Descriptive statistics, independent T-Test and Multivariable regression were used for analysis.

FINDINGS: Results indicate that both visit load of the patients with chronic conditions (hypertension and diabetes) and their average daily admission were decreased significantly during a year after COVID-19 pandemic compared to the similar period before COVID-19 outbreak. The moderate average score of the patients` experience towards continuity of care during the pandemic was also reported. Regression analysis showed that age for the diabetes patients and insurance status for the hypertension patients affect the COC mean scores.

CONCLUSION: COVID-19 pandemic causes serious decline in the continuity of care for patients with chronic conditions. Such a deterioration not only can lead to make these patients` condition worse in a long-term period but also it can make irreparable damages to the whole community and the health system. To make the health systems resilient particularly in disasters, serious attention should be taken into consideration among them, developing the tele-health technologies, improving the primary health care capacity, designing the applied responsive models of continuity of care, making multilateral participations and inter-sectoral collaborations, allocating sustainable resources, and enabling the patients with selfcare skills are more highlighted.

PMID:37393225 | DOI:10.1186/s12875-023-02086-6

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Comparison of painful temporomandibular disorders, psychological characteristics, sleep quality, and oral health-related quality of life of patients seeking care before and during the Covid-19 pandemic

BMC Oral Health. 2023 Jul 1;23(1):438. doi: 10.1186/s12903-023-03158-w.

ABSTRACT

BACKGROUND: Literature concerning Temporomandibular disorders (TMDs) and the Covid-19 pandemic is limited and disparate findings related to TMD frequencies, psychological distress, and quality of life were presented. This study investigated the prevalence of painful Temporomandibular disorders (TMDs) and compared the psychological, sleep, and oral health-related quality of life profiles of patients seeking TMD care before and during the Covid-19 pandemic.

METHODS: Data were accrued from consecutive adult patients 12 months before (BC; control) and during (DC; case group) the Covid-19 pandemic. The Diagnostic Criteria for TMDs (DC/TMD), Depression, Anxiety, Stress Scales (DASS)-21, Pittsburgh Sleep Quality Index (PSQI), and Oral Health Impact Profile (OHIP)-TMDs were utilized and statistical analysis was performed using Chi-square/non-parametric tests (α = 0.05).

RESULTS: The prevalence of painful TMDs was 50.8% before and 46.3% during the pandemic. Significant differences in PSQI and OHIP component scores were discerned between the BC and DC groups contingent on TMD pain. Total-DASS was moderately correlated to total-PSQI/OHIP (rs = 0.41-0.63).

CONCLUSION: The covid-19 pandemic did not appear to exacerbate psychological distress but affected sleep and increased unease over TMD dysfunction.

PMID:37393220 | DOI:10.1186/s12903-023-03158-w