Category: Statistics

In Vivo. 2021 Nov-Dec;35(6):3495-3499. doi: 10.21873/invivo.12651.

ABSTRACT

BACKGROUND/AIM: COVID-19 may lead to progressive respiratory failure as a consequence of alveolar damage, resulting in death. The aim of this study was to evaluate cytogenetic damage in oral cells of COVID-19 patients by micronucleus assay.

PATIENTS AND METHODS: A total of 11 COVID-19 patients aged 40.7±9.3 years (5 men and 6 women) were included in this study. For the control group, a total of 15 participants not infected with SARS-CoV-2 virus were included. The mean age was 41.6±6.2 years (5 men and 10 women).

RESULTS: The results showed statistically significant differences (p<0.05) in micronucleated buccal mucosa cells of COVID-19 patients. In addittion, a statistically significant increase in karyolysis and karrhyorexis (p<0.05) was observed in COVID-19 patients compared to control.

CONCLUSION: SARS-CoV-2 virus can induce mutagenesis and cytotoxicity in oral cells.

PMID:34697187 | DOI:10.21873/invivo.12651

In Vivo. 2021 Nov-Dec;35(6):3459-3466. doi: 10.21873/invivo.12646.

ABSTRACT

BACKGROUND/AIM: Neoadjuvant or perioperative chemotherapy is the standard treatment for locally advanced gastric cancer. However, in Eastern countries this is still debated. The aim of our study was to evaluate the survival impact of neoadjuvant chemotherapy.

PATIENTS AND METHODS: A total of 60 patients who underwent preoperative chemotherapy were compared to patients with locally advanced gastric cancer that underwent upfront surgery.

RESULTS: Median survival of the entire group curatively treated was 41 months with a median progression-free survival of 38 months. By excluding patients with stage IV disease from the neoadjuvant group, a statistically significant difference was reached both in terms of overall survival and disease-free survival. By subdividing patients according to pTNM stages, neoadjuvant patients showed better survival in stage I and II.

CONCLUSION: Neoadjuvant chemotherapy could be an effective treatment for locally advanced disease. However, randomized studies are still needed to fully understand its role and identify patients that will benefit from it.

PMID:34697182 | DOI:10.21873/invivo.12646

In Vivo. 2021 Nov-Dec;35(6):3483-3488. doi: 10.21873/invivo.12649.

ABSTRACT

BACKGROUND: Resection of the primary lesion with radical lymph node dissection is the most promising treatment avenue for patients with cancer. On the other hand, these procedures often induce excessive intraoperative blood loss (IBL) and require perioperative blood transfusion. The influence of IBL on the long-term postoperative outcomes of patients with digestive cancer is controversial. We investigated the impact of IBL on survival and recurrence after curative surgery in patients with colorectal cancer (CRC) in a single study group.

PATIENTS AND METHODS: In total, 1,597 patients who underwent radical resection for CRC at three group hospitals between 2000 and 2019 were reviewed. Patients were classified into a group with high IBL (≥200 ml) or low IBL (<200 ml). The risk factors for disease-free (DFS) and overall (OS) survival were analyzed.

RESULTS: A total of 489 and 1,108 patients were classified into the high and low IBL groups, respectively. The OS and DFS rates at 5 years after surgery were 89.3% and 63.4%, respectively, for the high IBL group and 96.9% and 77.8% for the low IBL group; these differences were statistically significantly (p<0.001). The multivariate analysis demonstrated that IBL was a significant independent risk factor for OS and DFS.

CONCLUSION: The amount of IBL was associated with significant differences in the OS and DFS of patients with stage II/III CRC who received curative resection. The surgical procedure, surgical strategy, and perioperative care should be carefully planned to avoid causing IBL.

PMID:34697185 | DOI:10.21873/invivo.12649

Lupus Sci Med. 2021 Oct;8(1):e000534. doi: 10.1136/lupus-2021-000534.

ABSTRACT

OBJECTIVES: To evaluate the risk of psychiatric disorders and all-cause mortality associated with belimumab therapy in patients with SLE.

METHODS: A literature search of four electronic bibliographic databases, including PubMed, EMBASE, Scopus and Cochrane databases, was conducted for randomised controlled trials (RCTs) reporting adverse reactions between belimumab and placebo. OR and 95% CI were calculated using the Mantel-Haenszel method with fixed-effects or random-effects model, depending on the heterogeneity test.

RESULTS: In total, 11 eligible RCTs including 8824 patients with SLE were randomised into belimumab (5160 patients with 5552 patient-years) and placebo (3664 patients with 3985 patient-years) groups, respectively. Overall, no increased risk was identified with belimumab therapy at all dosages compared with placebo in patients with SLE regarding all psychiatric disorders (OR 0.89, 95% CI 0.64 to 1.23, I²=58%) and all-cause mortality (OR 1.10, 95% CI 0.64 to 1.89, I²=0%). The subgroup analysis of psychiatric disorders also revealed no statistically elevated risks in serious psychiatric disorders (OR 1.15, 95% CI 0.77 to 1.70, I²=47%), non-serious psychiatric disorders (OR 0.83, 95% CI 0.60 to 1.16, I²=52%), suicidal ideation or behaviour (OR 0.87, 95% CI 0.57 to 1.33, I²=0%), and depression (OR 1.29, 95% CI 0.90 to 1.85, I²=15%). Secondary analysis restricting belimumab at approved dose of 10 mg/kg only yielded similar results.

CONCLUSION: Belimumab therapy overall does not increase psychiatric events and all-cause mortality risks, whereas the results from Belimumab Assessment of Safety in SLE Study are suggestive of increased risk of psychiatric adverse events with belimumab exposure. Consequently, post-marketing data are needed to ascertain its psychiatric safety, especially serious mental disorders.

PMID:34697129 | DOI:10.1136/lupus-2021-000534

In Vivo. 2021 Nov-Dec;35(6):3233-3243. doi: 10.21873/invivo.12618.

ABSTRACT

BACKGROUND: Expression of kallikrein-11 (KLK11) has been found to be related to the prognosis of various human cancer types but its physiological functions in the steps of breast cancer (BC) progression are still unknown.

MATERIALS AND METHODS: BC and adjacent normal breast tissue samples were collected from 28 patients. KLK11 expression levels were determined by real-time polymerase chain reaction for each sample and associations with known prognostic features were statistically analyzed.

RESULTS: Although there was slight up-regulation in tumor tissues overall, significant down-regulation of KLK11 expression in tumor tissue was observed in the elderly and in patients with perineural invasion. Furthermore, tumor size, grade, mitotic score, necrosis, calcification, lymphatic invasion, hormone receptor status and Ki67 expression were associated with altered KLK11 level.

CONCLUSION: Changes in expression levels of KLK11, associated with patient characteristics, might be used as complementary data in order to predict clinical outcome and prognosis in BC.

PMID:34697154 | DOI:10.21873/invivo.12618

BMJ Open. 2021 Oct 25;11(10):e053678. doi: 10.1136/bmjopen-2021-053678.

ABSTRACT

OBJECTIVE: Analysis of participatory approaches to developing health interventions for migrants and how approaches embody core participatory principles of inclusivity and democracy.

DESIGN: A systematic review of original articles. Electronic searches within the databases MEDLINE, Embase, Global Health and PsychINFO (from inception-November 2020).

ELIGIBILITY CRITERIA FOR STUDY SELECTION: Original peer-reviewed articles reporting research to develop and implement a health intervention for migrants, incorporating participatory approaches. We defined migrants as foreign-born individuals. Only articles reporting the full research cycle (inception, design, implementation, analysis, evaluation, dissemination) were included.

DATA EXTRACTION: We extracted information related to who was involved in research (migrants or other non-academic stakeholders), the research stage at which they were involved (inception, design, implementation, analysis, evaluation, dissemination), the method of their involvement and how this aligned with the core principles of participatory research-categorising studies as exhibiting active or pseudo (including proxy and indirect) participation.

RESULTS: 1793 publications were screened, of which 28 were included in our analysis. We found substantial variation in the application of participatory approaches in designing health interventions targeting migrants: across 168 individual research stages analysed across the 28 studies, we recorded 46 instances of active participation of migrants, 30 instances of proxy participation and 24 instances of indirect participation. All studies involved non-academic stakeholders in at least one stage of the research, only two studies exhibited evidence of active participation of migrants across all research stages. Evidence is limited due to the variability of terms and approaches used.

CONCLUSIONS: Important shortfalls in the meaningful inclusion of migrants in developing health interventions exist, suggesting a more rigorous and standardised approach is warranted to better define and deliver participatory research and improve quality.

REGISTRATION: This review followed Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines and is registered on the Open Science Framework (osf.io/2bnz5).

PMID:34697122 | DOI:10.1136/bmjopen-2021-053678

BMJ Open. 2021 Oct 25;11(10):e055125. doi: 10.1136/bmjopen-2021-055125.

ABSTRACT

OBJECTIVE: To assess the magnitude of dietary diversity and associated factors among pregnant women in the rural communities of Jimma Zone, south-west Ethiopia.

DESIGN: A community-based cross-sectional study was conducted from 1 June to 30 June 2020.

SETTINGS: The study was conducted in Seka Chekorsa and Mana districts. From a total of 63 listed kebeles, 21 were randomly selected.

PARTICIPANTS: Three hundred sixty first-trimester pregnant women have participated in this study. We used a systematic random sampling method to select the participants after a home-to-home census.

PRIMARY AND SECONDARY OUTCOMES: Dietary diversity was assessed using a 24 hours dietary recall method. Descriptive statistics were computed to describe the study subjects. Bivariate and multivariable logistic regression was run to control for all possible confounding effects and measure the strength of association between the outcome of interest and predictor.

RESULTS: The overall magnitude of adequate dietary diversity was found to be 186 (51.7%); 95% CI 46.1% to 56.4%). Having attended elementary education (adjusted OR (AOR)=2.45; 95% CI 1.33 to 4.51), completed grade 8 (AOR=6.05; 95% CI 2.65 to 13.80), attended high school (AOR=11.69; 95% CI 3.76 to 36.27), completed high school and above (AOR=2.92; 95% CI 1.16 to 7.32), husbands attended high school (AOR=2.92; 95% CI 1.15 to 7.47), family size of less than five (AOR=3.44; 95% CI to 1.77-6.66) were positively significantly associated with adequate dietary diversity. On the other hand, not had additional meal during pregnancy (AOR=0.42; 95% CI 0.21 to 0.83) was negatively associated with adequate dietary diversity.

CONCLUSIONS: We observed that the adequate dietary diversity score of pregnant women was low compared with the pooled proportion of dietary diversity conducted in Ethiopia. Therefore, strengthening and promoting female education through intersectoral collaborations and additional meal counselling during pregnancy is indispensable.

PMID:34697127 | DOI:10.1136/bmjopen-2021-055125

BMJ Open. 2021 Oct 25;11(10):e052777. doi: 10.1136/bmjopen-2021-052777.

ABSTRACT

OBJECTIVES: We conducted a systematic literature review and meta-analysis of observational studies to investigate the association between diabetes, hypertension, body mass index (BMI) or smoking with the risk of death in patients with COVID-19 and to estimate the proportion of deaths attributable to these conditions.

METHODS: Relevant observational studies were identified by searches in the PubMed, Cochrane library and Embase databases through 14 November 2020. Random-effects models were used to estimate summary relative risks (SRRs) and 95% CIs. Certainty of evidence was assessed using the Cochrane methods and the Grading of Recommendations, Assessment, Development and Evaluations framework.

RESULTS: A total of 186 studies representing 210 447 deaths among 1 304 587 patients with COVID-19 were included in this analysis. The SRR for death in patients with COVID-19 was 1.54 (95% CI 1.44 to 1.64, I²=92%, n=145, low certainty) for diabetes and 1.42 (95% CI 1.30 to 1.54, I²=90%, n=127, low certainty) for hypertension compared with patients without each of these comorbidities. Regarding obesity, the SSR was 1.45 (95% CI 1.31 to 1.61, I²=91%, n=54, high certainty) for patients with BMI ≥30 kg/m² compared with those with BMI <30 kg/m² and 1.12 (95% CI 1.07 to 1.17, I²=68%, n=25) per 5 kg/m² increase in BMI. There was evidence of a J-shaped non-linear dose-response relationship between BMI and mortality from COVID-19, with the nadir of the curve at a BMI of around 22-24, and a 1.5-2-fold increase in COVID-19 mortality with extreme obesity (BMI of 40-45). The SRR was 1.28 (95% CI 1.17 to 1.40, I²=74%, n=28, low certainty) for ever, 1.29 (95% CI 1.03 to 1.62, I²=84%, n=19) for current and 1.25 (95% CI 1.11 to 1.42, I²=75%, n=14) for former smokers compared with never smokers. The absolute risk of COVID-19 death was increased by 14%, 11%, 12% and 7% for diabetes, hypertension, obesity and smoking, respectively. The proportion of deaths attributable to diabetes, hypertension, obesity and smoking was 8%, 7%, 11% and 2%, respectively.

CONCLUSION: Our findings suggest that diabetes, hypertension, obesity and smoking were associated with higher COVID-19 mortality, contributing to nearly 30% of COVID-19 deaths.

TRIAL REGISTRATION NUMBER: CRD42020218115.

PMID:34697120 | DOI:10.1136/bmjopen-2021-052777

BMJ Open. 2021 Oct 25;11(10):e052841. doi: 10.1136/bmjopen-2021-052841.

ABSTRACT

OBJECTIVES: People with epilepsy (PWE) have a higher mortality rate than the general population. Epilepsy-related deaths have increased despite all-cause mortality decreasing in the general population pre-COVID-19. We hypothesised that clinical and lifestyle factors may identify people more at risk.

DESIGN: We used a retrospective cohort study to explore cause of death and a nested case-control study to identify risk factors.

SETTING: We explored factors associated with mortality using primary care population data from 1 April 2004 to 31 March 2014. Data were obtained from the Clinical Practice Research Datalink which compiles anonymised patient data from primary care in the UK. Cause of death data was supplemented from the Office of National Statistics when available.

PARTICIPANTS: The analysis included 70 431 PWE, with 11 241 registered deaths.

RESULTS: The number of deaths within the database increased by 69% between the first and last year of the study. Epilepsy was considered as a contributing cause in approximately 45% of deaths of PWE under 35. Factors associated with increased risk of death included attendance at emergency departments and/or emergency admissions (OR 3.48, 95% CI 3.19 to 3.80), antiepileptic drug (AED) polytherapy (2 AEDs: OR 1.60, 95% CI 1.51 to 1.71; 3 AEDs: OR 2.06, 95% CI 1.86 to 2.29; 4+AEDs: OR 2.62, 95% CI 2.23 to 3.08), status epilepticus (OR 2.78, 95% CI 1.64 to 4.71), depression (OR 1.67, 95% CI 1.57 to 1.76) and injuries (OR 1.54, 95% CI 1.43 to 1.67). No seizures in the prior year (OR 0.52, 95% CI 0.41 to 0.65).

CONCLUSION: Our results add to existing evidence that deaths in epilepsy are increasing. Future studies could focus on identifying PWE at high risk and addressing them with clinical interventions or better self-management. Identifying specific risk factors for younger people should be a priority as epilepsy may be a factor in close to half of deaths of PWE under 35 years of age.

PMID:34697121 | DOI:10.1136/bmjopen-2021-052841

BMJ Open. 2021 Oct 25;11(10):e051136. doi: 10.1136/bmjopen-2021-051136.

ABSTRACT

INTRODUCTION: Postpartum fatigue is a common symptom among new mothers after their pregnancy. It has a considerable negative impact on women’s functional and mental status as well as the development of babies. Identifying effective interventions to prevent or reduce postpartum fatigue is meaningful to improve the quality of life and avoid adverse outcomes of this vulnerable population. This systematic review aims to synthesise non-pharmacological evidence and evaluate the effectiveness of interventions for reducing postpartum fatigue among puerperas.

METHODS AND ANALYSIS: This review will be conducted in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. We will systematically search the Cochrane Library, PubMed, Embase, Web of Science, PsycINFO, CINAHL and ProQuest databases to identify clinical trials implementing non-pharmacological interventions conducted during 0-78 weeks postpartum for fatigue reduction. An additional search of OpenGrey will be conducted to identify grey literature. The search will be performed on 30 March 2021 without restrictions on time and language. Two independent reviewers will be responsible for study selection, data extraction and study quality assessment. The Cochrane risk-of-bias tool will be adopted to evaluate the risk biases of the included randomised controlled trials, and the Risk of Bias in Non-randomised Studies of Interventions will be applied to evaluate non-randomised controlled trials. Any disagreements will be referred to a third reviewer to reach a consensus. Findings will be qualitatively synthesised, and a meta-analysis will be conducted for the statistical combination if outcome data are sufficient and available.

ETHICS AND DISSEMINATION: This systematic review will not involve the collection of primary data and will be based on published data. Therefore, ethics approval is not required. The final findings will be disseminated through peer-reviewed journals and academic conferences.

PROSPERO REGISTRATION NUMBER: CRD42021234869.

PMID:34697115 | DOI:10.1136/bmjopen-2021-051136