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Nevin Manimala Statistics

Radiation-induced sarcoma in patients with nasopharyngeal carcinoma: a single-institution retrospective study

Lin Chuang Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2024 Jun;38(6):514-517. doi: 10.13201/j.issn.2096-7993.2024.06.011.

ABSTRACT

Objective:To analyze the clinical features, treatment methods and prognosis of radiation-induced sarcoma(RIS) of the head and neck after radiotherapy for nasopharyngeal carcinoma(NPC), and explore its treatment strategies. Methods:A retrospective analysis was conducted on RIS patients after radiotherapy for NPC in the People’s Hospital of Guangxi Zhuang Autonomous Region from January 2013 to October 2022. The time of onset, lesion location, pathological subtypes, imaging features and treatment outcomes were described, and the median survival time was statistically analyzed through follow-up. Results:This study included 10 patients with an interval of 2-27 years between NPC and RIS. The nasopharynx was the more common site of RIS, and osteosarcoma was the main pathological type. The median overall survival was 18 months. The median survival was 40 months in the surgery combined with the chemotherapy group, and 12 months in the surgery alone group. The 1-and 2-year cumulative survival rates were 48% and 36%, respectively. Prognostic analysis showed that gender, age of onset, time of sarcoma onset after radiotherapy and treatment methods might not be influencing factors for prognosis, and osteosarcomas presented a poorer prognosis than other pathological types. Conclusion:RIS is one of the most severe long-term adverse effects in patients with NPC. The prognosis of RIS is poor, and complete surgical resection of the tumor can improve patient survival rates. In cases where complete surgical resection is challenging, radiotherapy or chemotherapy may offer some improvement in tumor control.

PMID:38858117 | DOI:10.13201/j.issn.2096-7993.2024.06.011

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Comparison of 5-year survival rate and analysis of prognostic factors influencing the prognosis of adenoid cystic carcinoma and squamous cell carcinoma of the maxillary sinus: based on the SEER database

Lin Chuang Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2024 Jun;38(6):485-489. doi: 10.13201/j.issn.2096-7993.2024.06.006.

ABSTRACT

Objective:To analyze the difference in 5-year survival between maxillary sinus adenoidal cystic carcinoma(maxillary sinus adenoid cystic carcinoma, MSACC) and squamous cell carcinoma(maxillary sinus squamous cell carcinoma, MSSCC) using the National Cancer Institute’s Surveillance, Epidemiology, and End. Results:database(SEER) and to explore the factors associated with the prognosis of the two tumors. Methods:The data of 161 patients with MSACC and 929 patients with MSSCC were collected from SEER database, and the 5-year overall survival rate(OS) and tumor specific survival rate(CSS) were compared between the two groups before and after propensity score matching. The forest map of multivariate Cox proportional hazard regression model was established to analyze the prognostic factors affecting the survival rate of patients with MSACC and MSSCC. Results:There were statistical differences in 5-year OS and CSS between MSACC and MSSCC before and after propensity score matching(P<0.001). Multivariate regression analysis showed that age, side of the disease, lymph node metastasis, operation and radiotherapy were the influencing factors of OS in MSACC, while age and operation were the influencing factors of CSS. Age, race, T grade, lymph node metastasis, systemic metastasis, surgery, radiotherapy and chemotherapy are the influencing factors of OS of MSSCC. Age, T grade, lymph node metastasis, systemic metastasis, surgery, radiotherapy and chemotherapy are the influencing factors of CSS. Conclusion:The 5-year survival rate of MSACC is higher than that of MSSCC. Surgery plays a positive role in the prognosis of the two kinds of tumors. The analysis results can provide some reference for their survival expectations and treatment choices.

PMID:38858112 | DOI:10.13201/j.issn.2096-7993.2024.06.006

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Effect of endoscopic surgery combined with chemotherapy and radiotherapy on prognosis of early nasopharyngeal carcinoma patients in high incidence area

Lin Chuang Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2024 Jun;38(6):472-476;484. doi: 10.13201/j.issn.2096-7993.2024.06.004.

ABSTRACT

Objective:To investigate the differences in the therapeutic effects of endoscopic surgery combined with chemotherapy and endoscopic surgery combined with radiotherapy in the treatment of early nasopharyngeal carcinoma, and to select individualized treatment strategy for early nasopharyngeal carcinoma. Methods:The clinical data of 68 patients with early nasopharyngeal carcinoma(T1-2N₀M₀) who received surgical treatment in a high-incidence area were retrospectively analyzed. According to different treatment methods, they were divided into the surgery + chemotherapy group(n=34, treated with endoscopic surgery combined with chemotherapy) and the surgery + radiotherapy group(n=34, treated with endoscopic surgery combined with radiotherapy). Propensity score matching was used to match the patient data between the two groups at a 1∶1 ratio. Patients were followed up, and the survival rates and hematological toxicities were compared between the two groups. Results:Twenty-four cases in the surgery + chemotherapy group and 24 cases in the surgery + radiotherapy group were successfully matched. After matching, there was no statistically significant difference in T stage, and clinical stage between the two groups(all P>0.05). The 3-year OS and DFS in the surgery + chemotherapy group were 100.0% and 95.8%, respectively, while the 3-year OS and DFS in the surgery + radiotherapy group were 100.0% and 100.0%, respectively, with no significant difference in survival rates between the two groups(both P>0.05). After treatment, there was no statistically significant difference in bone marrow suppression between the surgery + chemotherapy group and the surgery + radiotherapy group (all P> 0.05) Conclusion:Endoscopic surgery combined with chemotherapy and surgery combined with radiotherapy have comparable clinical efficacy in the treatment of early nasopharyngeal carcinoma, but without radiotherapy-related complications, which is worth further investigation.

PMID:38858110 | DOI:10.13201/j.issn.2096-7993.2024.06.004

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A non-comparative, randomized, phase II trial of atezolizumab or atezolizumab plus tiragolumab for programmed death-ligand 1-positive recurrent cervical cancer (SKYSCRAPER-04)

Int J Gynecol Cancer. 2024 Jun 10:ijgc-2024-005588. doi: 10.1136/ijgc-2024-005588. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate tiragolumab (anti-TIGIT) and atezolizumab (anti-PD-L1) as second- or third-line therapy for PD-L1-positive persistent/recurrent cervical cancer.

METHODS: In the open-label, non-comparative, randomized phase II SKYSCRAPER-04 trial (NCT04300647), patients with PD-L1-positive (SP263 tumor area positivity ≥5%) recurrent/persistent cervical cancer after 1-2 chemotherapy lines (≥1 platinum-based) were randomized 3:1 to atezolizumab 1200 mg with/without tiragolumab 600 mg every 3 weeks until disease progression or unacceptable toxicity. Stratification factors were performance status, prior (chemo)radiotherapy, and disease status. The primary endpoint was independent review committee-assessed confirmed objective response rate per RECIST v1.1 in patients receiving tiragolumab plus atezolizumab. An objective response rate ≥21% (one-sample z-test p≤0.0245) was required for statistical significance versus a historical reference.

RESULTS: Protocol-defined independent review committee-assessed objective response rates were 19.0% (95% CI 12.6 to 27.0) in 126 patients receiving tiragolumab plus atezolizumab (p=0.0787 vs historical reference) and 15.6% (95% CI 6.5 to 29.5) in 45 atezolizumab-treated patients. Response rates were higher in PD-L1high (tumor area positivity ≥10%) than PD-L1low (tumor area positivity 5%-9%) subgroups with both regimens. At 8.5 months’ median follow-up, independent review committee-assessed progression-free survival was 2.8 months (95% CI 1.7 to 4.1) with tiragolumab plus atezolizumab and 1.9 months (95% CI 1.5 to 3.0) with atezolizumab. In post hoc analyses (10.4 months’ median follow-up), median overall survival was 11.1 months (95% CI 9.6 to 14.5) with the combination and 10.6 months (95% CI 6.9 to 13.8) with atezolizumab (crossover permitted). In the combination group, 3% of patients had adverse events requiring treatment discontinuation and 8% had grade ≥3 adverse events of special interest; corresponding values in the single-agent arm were 4% and 11%. There were no treatment-related deaths or new safety findings.

CONCLUSION: The objective response rate with the tiragolumab-plus-atezolizumab combination was numerically higher than the historical reference but did not reach statistical significance.

PMID:38858106 | DOI:10.1136/ijgc-2024-005588

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Brain network topological changes in inflammatory bowel disease: an exploratory study

Eur J Neurosci. 2024 Jun 10. doi: 10.1111/ejn.16442. Online ahead of print.

ABSTRACT

Although the aetio-pathogenesis of inflammatory bowel diseases (IBD) is not entirely clear, the interaction between genetic and adverse environmental factors may induce an intestinal dysbiosis, resulting in chronic inflammation having effects on the large-scale brain network. Here, we hypothesized inflammation-related changes in brain topology of IBD patients, regardless of the clinical form [ulcerative colitis (UC) or Crohn’s disease (CD)]. To test this hypothesis, we analysed source-reconstructed magnetoencephalography (MEG) signals in 25 IBD patients (15 males, 10 females; mean age ± SD, 42.28 ± 13.15; mean education ± SD, 14.36 ± 3.58) and 28 healthy controls (HC) (16 males, 12 females; mean age ± SD, 45.18 ± 12.26; mean education ± SD, 16.25 ± 2.59), evaluating the brain topology. The betweenness centrality (BC) of the left hippocampus was higher in patients as compared with controls, in the gamma frequency band. It indicates how much a brain region is involved in the flow of information through the brain network. Furthermore, the comparison among UC, CD and HC showed statistically significant differences between UC and HC and between CD and HC, but not between the two clinical forms. Our results demonstrated that these topological changes were not dependent on the specific clinical form, but due to the inflammatory process itself. Broader future studies involving panels of inflammatory factors and metabolomic analyses on biological samples could help to monitor the brain involvement in IBD and to clarify the clinical impact.

PMID:38858102 | DOI:10.1111/ejn.16442

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Comparative Evaluation of Lower Gadolinium Doses for MR Imaging of Meningiomas: How Low Can We Go?

AJNR Am J Neuroradiol. 2024 Jun 10:ajnr.A8375. doi: 10.3174/ajnr.A8375. Online ahead of print.

ABSTRACT

BACKGROUND AND PURPOSE: Gadolinium-based contrast agents are widely used for meningioma imaging; however, concerns exist regarding their side effects, cost, and environmental impact. At the standard gadolinium dose, most meningiomas show avid contrast enhancement suggesting that administering a smaller dose may be feasible. The purpose of this study was to evaluate the impact of a lower gadolinium dose on the differentiation between meningiomas and adjacent intracranial tissues.

MATERIALS AND METHODS: 108 patients with presumed or confirmed meningiomas who underwent brain MRI at multiple doses of gadolinium were included in the study. The patients’ MRIs were categorized into three groups based on the gadolinium dose administered: Micro (approximately 25% of the standard dose), Low (approximately 62% of the standard dose) and Standard dose. Multi-reader qualitative visual assessment and quantitative relative signal differences calculations were performed to evaluate tumor differentiation from the cortex and from the dural venous sinus. The relative signal differences for each dose were analyzed using ANOVA for quantitative assessment and NcNemar for qualitative assessment. Additionally, non-inferiority testing was used to compare the Low and Micro doses to the Standard dose.

RESULTS: Decreasing the gadolinium dose to a Low dose or a Micro dose resulted in a statistically significant decrease in signal difference between the tumor and the adjacent brain tissues (p<0.02). However, on visual assessment, the Low dose was non-inferior to the Standard dose. The proportion of cases with suboptimal differentiation was significantly higher for the Micro dose than for the Standard dose, both for the differentiation between the tumor and the cortex (p=0.041) and the differentiation between tumor and sinus (p<0.001).

CONCLUSIONS: Reducing the gadolinium dose to 62% of the standard level still allows for sufficient visual delineation of meningiomas from surrounding tissues. However, further reduction to 25% substantially compromises the ability to distinguish the tumor from adjacent structures and is, therefore, not advisable.

ABBREVIATIONS: GBCAs = Gadolinium-based contrast agents; SSS = Superior Sagittal Sinus.

PMID:38858096 | DOI:10.3174/ajnr.A8375

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Experimental design considerations and statistical analyses in preclinical tumor growth inhibition studies

Pharm Stat. 2024 Jun 10. doi: 10.1002/pst.2399. Online ahead of print.

ABSTRACT

Animal models are used in cancer pre-clinical research to identify drug targets, select compound candidates for clinical trials, determine optimal drug dosages, identify biomarkers, and ensure compound safety. This tutorial aims to provide an overview of study design and data analysis from animal studies, focusing on tumor growth inhibition (TGI) studies used for prioritization of anticancer compounds. Some of the experimental design aspects discussed here include the selection of the appropriate biological models, the choice of endpoints to be used for the assessment of anticancer activity (tumor volumes, tumor growth rates, events, or categorical endpoints), considerations on measurement errors and potential biases related to this type of study, sample size estimation, and discussions on missing data handling. The tutorial also reviews the statistical analyses employed in TGI studies, considering both continuous endpoints collected at single time-point and continuous endpoints collected longitudinally over multiple time-points. Additionally, time-to-event analysis is discussed for studies focusing on event occurrences such as animal deaths or tumor size reaching a certain threshold. Furthermore, for TGI studies involving categorical endpoints, statistical methodology is outlined to compare outcomes among treatment groups effectively. Lastly, this tutorial also discusses analysis for assessing drug combination synergy in TGI studies, which involves combining treatments to enhance overall treatment efficacy. The tutorial also includes R sample scripts to help users to perform relevant data analysis of this topic.

PMID:38858081 | DOI:10.1002/pst.2399

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Codesign and refinement of an optimised antenatal education session to better inform women and prepare them for labour and birth

BMJ Open Qual. 2024 Jun 10;13(2):e002731. doi: 10.1136/bmjoq-2023-002731.

ABSTRACT

OBJECTIVE: Our objective was to codesign, implement, evaluate acceptability and refine an optimised antenatal education session to improve birth preparedness.

DESIGN: There were four distinct phases: codesign (focus groups and codesign workshops with parents and staff); implementation of intervention; evaluation (interviews, questionnaires, structured feedback forms) and systematic refinement.

SETTING: The study was set in a single maternity unit with approximately 5500 births annually.

PARTICIPANTS: Postnatal and antenatal women/birthing people and birth partners were invited to participate in the intervention, and midwives were invited to deliver it. Both groups participated in feedback.

OUTCOME MEASURES: We report on whether the optimised session is deliverable, acceptable, meets the needs of women/birthing people and partners, and explain how the intervention was refined with input from parents, clinicians and researchers.

RESULTS: The codesign was undertaken by 35 women, partners and clinicians. Five midwives were trained and delivered 19 antenatal education (ACE) sessions to 142 women and 94 partners. 121 women and 33 birth partners completed the feedback questionnaire. Women/birthing people (79%) and birth partners (82%) felt more prepared after the class with most participants finding the content very helpful or helpful. Women/birthing people perceived classes were more useful and engaging than their partners. Interviews with 21 parents, a midwife focus group and a structured feedback form resulted in 38 recommended changes: 22 by parents, 5 by midwives and 11 by both. Suggested changes have been incorporated in the training resources to achieve an optimised intervention.

CONCLUSIONS: Engaging stakeholders (women and staff) in codesigning an evidence-informed curriculum resulted in an antenatal class designed to improve preparedness for birth, including assisted birth, that is acceptable to women and their birthing partners, and has been refined to address feedback and is deliverable within National Health Service resource constraints. A nationally mandated antenatal education curriculum is needed to ensure parents receive high-quality antenatal education that targets birth preparedness.

PMID:38858078 | DOI:10.1136/bmjoq-2023-002731

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Relevance of meeting general outpatients’ information needs to their perceptions of healthcare quality in a hospital in Ghana: a Healthcare Quality Survey using modified SERVQUAL analysis

BMJ Open Qual. 2024 Jun 10;13(2):e002683. doi: 10.1136/bmjoq-2023-002683.

ABSTRACT

BACKGROUND: Patients determine quality of healthcare by their perception of the gap between the healthcare they experience/receive and that which they expect. This can be influenced by the ability of healthcare staff to adequately communicate information about the healthcare provided. This study assessed the level of relevance of meeting patients’ information needs with respect to their assessment of healthcare quality in a private hospital’s general outpatient department in Ghana.

DESIGN: Study design was cross-sectional using exit self-administered questionnaires among 390 outpatients. Healthcare quality was measured using a modified form of the Service Quality model gap analysis (gap between experience and expectations). A negative gap signifies unmet patient expectations. Microsoft Excel and Stata V.15.0 were used for analysis using t-test and multiple linear regression. A p value ≤0.05 denotes statistical significance.

FINDINGS: The mean percentage of patients’ expectations of quality of healthcare was 87.6% (SE 0.031), while patient experience was 86.0% (SE 0.029), with a significant negative gap of -0.08 (p<0.002). Their highest expectation of the quality of healthcare was for their information needs to be met, with a mean score of 4.44 (SE 0.03). Two of the four items under the information needs dimension that showed no statistically significant gaps were ‘saying all their problems’ (gap=0.00; p<0.9) and ‘explanation of treatment/medications’ (gap=0.01; p<0.6). Those with statistically significant negative gaps were ‘explanation of investigations and procedures’ (gap=-0.18; p<0.0001) and ‘explanation of the diagnoses’ (gap=-0.11; p<0.02), signifying unmet expectations.

CONCLUSIONS: The outpatient’s greatest need for quality healthcare in this study was for their information needs to be met. Providing information on patient diagnoses and investigations are the areas least likely to be adequately communicated to patients.

PMID:38858077 | DOI:10.1136/bmjoq-2023-002683

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Development of a novel rapid response event review process for quality improvement

BMJ Open Qual. 2024 Jun 10;13(2):e002664. doi: 10.1136/bmjoq-2023-002664.

ABSTRACT

INTRODUCTION: Rapid response team (RRT) and code activation events occur relatively commonly in inpatient settings. RRT systems have been the subject of a significant amount of analysis, although this has been largely focused on the impact of RRT system implementation and RRT events on patient outcomes. There is reason to believe that the structured assessment of RRT and code events may be an effective way to identify opportunities for system improvement, although no standardised approach to event analysis is widely accepted. We developed and refined a protocolised system of RRT and code event review, focused on sustainable, timely and high value event analysis meant to inform ongoing improvement activities.

METHODS: A group of clinicians with expertise in process and quality improvement created a protocolised analytic plan for rapid response event review, piloted and then iteratively optimised a systematic process which was applied to all subsequent cases to be reviewed.

RESULTS: Hospitalist reviewers were recruited and trained in a methodical approach. Each reviewer performed a chart review to summarise RRT events, and collect specific variables for each case (coding). Coding was then reviewed for concordance, at monthly interdisciplinary group meetings and ‘Action Items’ were identified and considered for implementation. In any 12-month period starting in 2021, approximately 12-15 distinct cases per month were reviewed and coded, offering ample opportunities to identify trends and patterns.

CONCLUSION: We have developed an innovative process for ongoing review of RRT-Code events. The review process is easy to implement and has allowed for the timely identification of high value improvement opportunities.

PMID:38858076 | DOI:10.1136/bmjoq-2023-002664