Categories
Nevin Manimala Statistics

Analysis of risk factors related to extremely and very preterm birth: a retrospective study

BMC Pregnancy Childbirth. 2022 Nov 5;22(1):818. doi: 10.1186/s12884-022-05119-7.

ABSTRACT

BACKGROUND: Preterm birth is one of the main causes of perinatal morbidity and mortality and imposes a heavy burden on families and society. The aim of this study was to identify risk factors and analyze birth conditions and complications of newborns born at < 32 gestational weeks for extremely preterm (EP) and very preterm (VP) birth in the clinic to further extend the gestational period.

METHODS: We performed a retrospective cohort study and collected data from 1598 pregnant women and 1660 premature newborns (excluding 229 premature babies who died due to severe illness and abandonment) admitted to the Obstetrics and Gynecology Hospital Affiliated with Nanjing Medical University in China from 2016 to 2020. We compared women’s and newborns’ characteristics by t-tests and Chi-square tests for continuous and categorical variables, respectively. Multivariable logistic regression was performed to estimate the effects of risk factors on EP and VP birth.

RESULTS: We identified 3 independent risk factors for EP birth: cervical incompetency (P < 0.001); multiple pregnancy (P < 0.01), primipara (P < 0.001). Additionally, we identified 4 independent risk factors for VP birth: gestational diabetes mellitus (GDM) (P < 0.05), preterm premature rupture of membrane (PPROM) (P < 0.01), fetal intrauterine distress (P < 0.001), and hypertensive disorder complicating pregnancy (HDCP) (P < 0.001). In addition, pairwise comparisons revealed statistically significant differences in the incidence rates of neonatal pneumonia, bronchopulmonary dysplasia (BPD) and sepsis between the 28-28 + 6 and 29-29 + 6 weeks of gestation groups (P < 0.05). Compared with 28-28 + 6 weeks of gestation, neonatal complications were significantly more common at < 26 weeks of gestation (P < 0.05). The incidence rates of neonatal intracranial hemorrhage(NICH), patent ductus arteriosus(PDA), patent foramen ovale(PFO), pneumonia, BPD and sepsis were significantly higher in the 26-26 + 6 and 27-27 + 6 gestational weeks than in the 28-28 + 6 gestational weeks (P < 0.05).

CONCLUSION: PPROM, is the most common risk factor for EP and VP birth, and cervical insufficiency, multiple pregnancy, and primipara are independent risk factors for EP birth. Therefore, during pregnancy, attention should be devoted to the risk factors for PPROM, and reproductive tract infection should be actively prevented to reduce the occurrence of PPROM. Identifying the risk factors for cervical insufficiency, actively intervening before pregnancy, and cervical cervix ligation may be considered to reduce the occurrence of EP labor. For iatrogenic preterm birth, the advantages and disadvantages should be carefully weighed, and the gestational period should be extended beyond 28 weeks to enhance the safety of the mother and child and to improve the outcomes of preterm birth.

PMID:36335328 | DOI:10.1186/s12884-022-05119-7

Categories
Nevin Manimala Statistics

Hepatitis B, C and human immunodeficiency virus knowledge among the general greek population: results from the Hprolipsis nationwide survey

BMC Public Health. 2022 Nov 5;22(1):2026. doi: 10.1186/s12889-022-14353-9.

ABSTRACT

BACKGROUND: Although several studies on hepatitis B (HBV), C (HCV) and human immunodeficiency virus (HIV) infection have been conducted in Greece, little is known on the knowledge level of the Greek population towards these three infections. Our aim was to assess the knowledge level of the adult Greek general population about the HBV, HCV and HIV.

METHODS: Data were derived from the first general population health survey, Hprolipsis. The sample was selected by multistage stratified random sampling. A standardized questionnaire was administered by trained interviewers during home visits. A knowledge score was constructed based on responses to 17 per infection selected items and categorized in three levels; high (12-17 correct replies) medium (6-11) and low (0-5). Among 8,341 eligible individuals, 6,006 were recruited (response rate: 72%) and 5,878 adults (≥ 18 years) were included in the analysis. The statistical analysis accounted for the study design.

RESULTS: Only 30.4%, 21.6%, and 29.6% of the participants had a high overall knowledge level of HBV, HCV and HIV, respectively. These low percentages were mainly attributed to the high levels of misconception about transmission modes (65.9%, 67.2%, and 67.9%, respectively). Results showed that increasing age and living out of the big metropolitan cities were associated with decreased odds of having higher knowledge. Female gender, higher education level, higher monthly family income, higher medical risk score, history of testing and being born in Greece or Cyprus, were associated with increased odds of having higher knowledge.

CONCLUSIONS: There are significant knowledge gaps in the Greek general population regarding modes of transmission, preventive measures and treatment availability for HBV, HCV and HIV. There is an urgent need for large scale but also localized awareness activities targeted to less privileged populations, to fill the gaps in knowledge and increase population engagement in preventive measures.

PMID:36335324 | DOI:10.1186/s12889-022-14353-9

Categories
Nevin Manimala Statistics

Improved adherence to test, treat, and track (T3) malaria strategy among Over-the-Counter Medicine Sellers (OTCMS) through interventions implemented in selected rural communities of Fanteakwa North district, Ghana

Malar J. 2022 Nov 5;21(1):317. doi: 10.1186/s12936-022-04338-9.

ABSTRACT

BACKGROUND: Prompt diagnosis and treatment of malaria prevents a mild case from developing into severe disease and death. Unfortunately, parasitological testing of febrile children is greater in the public and formal private sector than in the informal private sector where many patients with malaria-like symptoms first seek treatment. This study was aimed at improving implementation of the T3 policy among OTCMS using some interventions that could be scaled-up easily at the national level.

METHODS: Interventions were evaluated using a two-arm, cluster randomized trial across 8 rural communities (4 clusters per arm), in two adjacent districts of Ghana. A total of 7 OTCMS in the intervention arm and 5 OTCMS in the control arm in the selected communities participated in the study. Five interventions were implemented in the intervention arm only. These were acquisition of subsidized malaria rapid diagnostic test (RDT) kits, training of OTCMS, supportive visits to OTCMS, community sensitization on malaria, and introduction of malaria surveillance tool. The primary outcome was the proportion of children under 10 years with fever or suspected to have malaria visiting OTCMS and getting tested (using RDT) before treatment. Secondary outcomes included OTCMS adherence to national malaria treatment guidelines and the recommended RDT retail price. Outcomes were measured using mystery client (an adult who pretends to be a real patient) surveys supplemented by a household survey. Proportions were compared using chi-square test or Fisher exact test.

RESULTS: Following deployment of interventions, mystery client survey showed that OTCMS’ adherence to malaria protocol in the intervention arm increased significantly (p < 0.05) compared to the control arm. Household surveys in the intervention arm showed that caregivers self-treating their children or visiting drug vendors significantly decreased in favour of visits to OTCMS shops for treatment (p < 0.001). End-line malaria testing rate was higher compared with the baseline rate, though not statistically significant (30.8% vs 10.5%; p = 0.1238). OTCMS in the intervention arm also adhered to the subsidized RDT retail price of GHc2.40.

CONCLUSION: Interventions targeting OTCMS in rural communities have the potential of improving adherence to the T3 malaria policy and subsequently improving management of uncomplicated malaria in Ghana.

TRIAL REGISTRATION: ISRCTN registry ISRCTN77836926. Registered on 4 November 2019.

PMID:36335323 | DOI:10.1186/s12936-022-04338-9

Categories
Nevin Manimala Statistics

Are anti-PD-1-associated immune related adverse events a harbinger of favorable clinical prognosis in patients with gastric cancer?

BMC Cancer. 2022 Nov 5;22(1):1136. doi: 10.1186/s12885-022-10199-x.

ABSTRACT

BACKGROUND: Immune checkpoint inhibitors (ICIs) has shown remarkable benefit in the treatment of a range of cancer types, although it may initiate immune related adverse events (irAEs) in patients. Some studies have shown that there is a close relationship between the occurrence of irAEs and prognosis. In present study, we have attempted to establish whether the occurrence of irAEs after the use of anti PD-1 antibodies is associated with treatment efficacy in people with advanced gastric cancer (AGC).

METHODS: This study included patients treated with the anti-PD-1 antibodies for AGC patients at The Fourth Hospital of Hebei Medical University. IrAEs were identified clinically and graded as per the National Cancer Institute Common Terminology Criteria for Adverse Events ver. 4.03. Efficacy was evaluated with objective response rate (ORR), disease control rate (DCR), progression free survival (PFS) and overall survival (OS). The analysis was performed to determine the association between irAEs and clinical outcomes.

RESULT: Of the 74 AGC patients in our study, 24 developed irAEs. The DCR of the irAE displayed a trend better than that of non-irAE group but without statistical difference (41.70% VS 6.0%, p = 0.118). Median PFS in the irAE group was superior to that in the non-irAE group (176 days VS 94 days, p = 0.001). Median OS also showed this trend of difference at borderline statistical level (292 days VS 239 days, p = 0.057). Multivariate analysis also demonstrated irAE (HR = 0.269, 95%CI: 0.088 to 0.822, p = 0.021) were associated independently with the better prognosis for AGC patients.

CONCLUSION: In advanced gastric cancer treated with anti PD-1 antibodies, the occourence of irAEs might contribute to the improved prognosis.

PMID:36335320 | DOI:10.1186/s12885-022-10199-x

Categories
Nevin Manimala Statistics

Combined atezolizumab and nab-paclitaxel in the treatment of triple negative breast cancer: a meta-analysis on their efficacy and safety

BMC Cancer. 2022 Nov 5;22(1):1139. doi: 10.1186/s12885-022-10225-y.

ABSTRACT

BACKGROUND: Triple negative breast cancer (TNBC) is clinically aggressive breast cancer with a poor prognosis. Approximately 20% of TNBC has been found to express programmed death ligand 1 (PD-L1), making it a potential therapeutic target. As a PD-L1 inhibitor, atezolizumab is a recently approved immunotherapeutic drug for TNBC, this meta-analysis (MA) was aimed to review the randomized controlled trial studies (RCTs) of combined atezolizumab and nab-paclitaxel in the treatment of TNBC and synthesize the evidence-based results on its effectiveness and safety.

METHOD: We searched PubMed, Embase, EBSCOhost and ClinicalTrials.gov for the eligible RCTs which compared the efficacy and safety of combined atezolizumab and nab-paclitaxel with nab-paclitaxel alone. The outcomes analyzed included overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and treatment-related adverse effects (AEs).

RESULTS: A total of six RCTs were included in this MA. For efficacy, although OS was not significantly prolonged with combined atezolizumab and nab-paclitaxel (HR 0.90, 95% CI [0.79, 1.01], p=0.08), this combination therapy significantly improved PFS (HR 0.72, 95% CI [0.59, 0.87], p=0.0006) and ORR (RR 1.25, 95% CI [0.79, 1.01] p<0.00001). For safety, any AEs, haematological, gastrointestinal, and liver AEs showed no statistically significant differences between the atezolizumab and nab-paclitaxel combination group and nab-paclitaxel alone group. However, serious AEs, high grade, dermatological, pulmonary, endocrine, and neurological AEs were significantly lower with nab-paclitaxel alone compared to atezolizumab and nab-paclitaxel combined (p-value range from <0.00001 to 0,02).

CONCLUSION: Atezolizumab combined with nab-paclitaxel was associated with improved outcomes in the treatment of TNBC; however, this combination resulted in more toxicity compared to nab-paclitaxel alone. While nab-paclitaxel alone produced chemotherapy-related AEs, the combination of atezolizumab with nab-paclitaxel produced AEs, especially immune-related AEs such as haematological, pulmonary, endocrine, and neurological AEs.

TRIAL REGISTRATION: This research work of systematic review has been registered on PROSPERO (Registration number: CRD42022297952).

PMID:36335316 | DOI:10.1186/s12885-022-10225-y

Categories
Nevin Manimala Statistics

Real-world data: a brief review of the methods, applications, challenges and opportunities

BMC Med Res Methodol. 2022 Nov 5;22(1):287. doi: 10.1186/s12874-022-01768-6.

ABSTRACT

BACKGROUND: The increased adoption of the internet, social media, wearable devices, e-health services, and other technology-driven services in medicine and healthcare has led to the rapid generation of various types of digital data, providing a valuable data source beyond the confines of traditional clinical trials, epidemiological studies, and lab-based experiments.

METHODS: We provide a brief overview on the type and sources of real-world data and the common models and approaches to utilize and analyze real-world data. We discuss the challenges and opportunities of using real-world data for evidence-based decision making This review does not aim to be comprehensive or cover all aspects of the intriguing topic on RWD (from both the research and practical perspectives) but serves as a primer and provides useful sources for readers who interested in this topic.

RESULTS AND CONCLUSIONS: Real-world hold great potential for generating real-world evidence for designing and conducting confirmatory trials and answering questions that may not be addressed otherwise. The voluminosity and complexity of real-world data also call for development of more appropriate, sophisticated, and innovative data processing and analysis techniques while maintaining scientific rigor in research findings, and attentions to data ethics to harness the power of real-world data.

PMID:36335315 | DOI:10.1186/s12874-022-01768-6

Categories
Nevin Manimala Statistics

Characteristics of intestinal-related lymphoid hyperplasia in children and its correlation with intussusception of children

BMC Pediatr. 2022 Nov 5;22(1):641. doi: 10.1186/s12887-022-03675-7.

ABSTRACT

BACKGROUND: Primary intussusception in children is a common acute abdominal disease. The cause of this disease is still not fully understood. Many articles have reported that children with intussusception are often accompanied by hyperplasia of mesenteric lymph nodes and submucosal lymphoid tissue of the terminal ileum. Therefore, hyperplasia of intestinal-associated lymphoid tissue (mesenteric lymph nodes and submucosal lymphoid tissue of the intestinal tract) may be one of the main causes of intussusception. However, the characteristics and differences of intestinal-associated lymphoid tissues in healthy children and children with intussusception at different ages have not been reported. In addition, the relationship between mesenteric lymph nodes and intestinal submucosal lymphatic tissue also needs to be further understood.

METHODS: 73 patients with intussusception during the recovery phase who were treated in our hospital from October 2019 to October 2021 were collected as the observation group, while 101 children with healthy physical examination or diseases unrelated to intestinal lymphoid hyperplasia were collected as the control group. They were divided into different age groups of 1-6 months, 7-12 months, 13-18 months, 19-24 months, 25-36 months, 3-4 years, 5-6 years, and 7-8 years old. Ultrasonography was used to explore and scan mesenteric lymph nodes in fixed areas of the right lower abdomen and around the umbilicus. The size (cm3) and number (n) of detectable lymph nodes in each region were recorded and calculated, and the total mesenteric lymph node volume (cm3) of the right lower abdomen (RLTMLNV) and periumbilical region (PTMLNV) was calculated, respectively. The total mesenteric lymph node volume of each region in different ages of the two groups was analyzed.

RESULTS: (1) There were significant differences between the control group and the observation group in the right lower abdominal total mesenteric lymph nodes volume (RLTMLNV) and the periumbilical total mesenteric lymph nodes volume (PTMLNV) (P = 0.001). The mesenteric lymph nodes in the observation group showed severe hyperplasia. (2) Children with intussusceptions are usually accompanied by severe mesenteric lymphoid hyperplasia. The mean volume value of RLTMLNV was greater than that of PTMLNV. Especially within 2 years of age, the mean value of RLTMLNV was significantly higher than that of PTMLNV with statistical significance (P < 0.05). (3) In normal children (control group), lymph nodes in the right lower abdomen and periumbilical area showed low hyperplasia, and there was a significant difference between age groups of < 2 years old and 2-8 years old (p = 0.001). In the children with intussusception (observation group), the hyperplasia of mesenteric lymph nodes in the right lower abdomen and around the umbilicus was severe. There was no significant difference in the proliferation of mesenteric lymphoid tissue among different age groups in the right lower abdomen (P = 0.834). There was also no significant difference in hyperplasia of periumbilical mesenteric lymphoid tissue among different age groups (P = 0.097).

CONCLUSIONS: Our research shows: (1) The occurrence of primary intussusception in children is related to the hyperplasia of intestinal-associated lymphoid tissue. (2) Children with intussusceptions were usually accompanied by severe mesenteric lymphoid hyperplasia. The mesenteric lymphoid hyperplasia was more evident in the right lower abdominal ileocecal area than in the periumbilical area before 2 years of age. RLTMLNV has better predictability of intussusception than PTMLNV. The occurrence of intussusceptions was more closely related to the hyperplasia of intestinal-associated lymphoid tissue in the right lower abdomen. (3) Normal children showed a low degree of mesenteric lymphoid hyperplasia before 2 years old, moderate hyperplasia after 2 years old, and mesenteric lymphoid hyperplasia in the right lower abdominal ileocecal area was basically the same as the periumbilical area. The lymphatic tissue of the right lower abdomen and periumbilical mesentery in children with intussusceptions showed severe hyperplasia, and there were no significant differences among different age groups.

PMID:36335308 | DOI:10.1186/s12887-022-03675-7

Categories
Nevin Manimala Statistics

The effect of implantable collamer Lens V4c on ocular biometric measurements and intraocular lens power calculation based on Pentacam-AXL and IOLMaster 500

BMC Ophthalmol. 2022 Nov 5;22(1):421. doi: 10.1186/s12886-022-02644-z.

ABSTRACT

BACKGROUND: To investigate the possible effect of implantable collamer lens (ICL) V4c on ocular biometric measurements by a new biometer Pentacam-AXL and partial coherence interferometry (PCI)-based IOLMaster 500 and intraocular lens power calculation using fourth-generation formula.

METHODS: We retrospectively enrolled patients who underwent ICL (EVO-V4c, STAAR Surgical Co. Nidau, Switzerland) implantation surgery from September 2020 to November 2021. The Pentacam-AXL and IOLMaster 500 biometers were used to measure axial length (AL), anterior chamber depth (ACD), keratometry (K), white to white (WTW), and central corneal thickness (CCT) values before and at least 2 months after ICL V4c implantation. The IOL power was calculated using the Barrett Universal II formula.

RESULTS: The study included 45 eyes in 28 patients. There was a significant increase in ALs (average 0.03 ± 0.07 mm, p = 0.01) and a significant decrease of ACDs (average 0.19 ± 0.17 mm, p < 0.001) based on Pentacam-AXL. Similar changes in ALs and ACDs were also found in IOLMaster 500. In addition, the difference in WTWs in the two devices and that of CCTs in Pentacam-AXL were statistically significant. However, the preoperative and postoperative K1 and K2 were separately comparable using either device. The IOL power calculated by the Barrett Universal II formula did not change significantly either by the software built in Pentacam-AXL or by manually putting the parameters of the IOLMaster 500 into the formula manually (p = 0.058, p = 0.675, respectively).

CONCLUSIONS: Ocular parameters including ALs, ACDs, WTWs, and CCTs using a new Pentacam-AXL and standard PCI-based IOLMaster 500 changed significantly before and after the ICL V4c implantation, while IOL power prediction using the Barrett Universal II formula was little affected.

PMID:36335303 | DOI:10.1186/s12886-022-02644-z

Categories
Nevin Manimala Statistics

5 year oncological outcomes of the HIGHLOW randomized clinical trial

Eur J Surg Oncol. 2022 Oct 28:S0748-7983(22)00709-0. doi: 10.1016/j.ejso.2022.10.017. Online ahead of print.

ABSTRACT

INTRODUCTION: The oncological outcomes of low ligation (LL) compared to high ligation (HL) of the inferior mesenteric artery (IMA) during low-anterior rectal resection (LAR) with total mesorectal excision are still debated. The aim of this study is to report the 5 year oncologic outcomes of patients undergoing laparoscopic LAR with either HL vs. LL of the IMA MATERIALS AND METHODS: Between June 2014 and December 2016, patients who underwent elective laparoscopic LAR + TME in 6 Italian non-academic hospitals were randomized to HL or LL of IMA after meeting the inclusion criteria (HighLow trial; ClinicalTrials.gov Identifier NCT02153801). We analyzed the rate of local recurrence, distant metastasis, overall survival, disease-specific survival, and disease-free survival at 5 years of patients previously enrolled.

RESULTS: Five-year follow up data were available for 196 patients. Recurrence happened in 42 (21.4%) of patients. There was no statistically significant difference in the distant recurrence rate (15.8% HL vs. 18.9% LL; P = 0.970) and pelvic recurrence rate (4,9% HL vs 3,2% LL; P = 0.843). No statistically significant difference was found in 5-year OS (p = 0.545), DSS (p = 0.732) or DFS (p = 0.985) between HL and LL. Low vs medium and upper rectum site of tumor, conversion rate, Clavien-Dindo post-operative grade ≥3 complications and tumor stage were found statistically significantly associated to poor oncological outcomes in univariate analysis; in multivariate analysis, however, only conversion rate and stage 3 cancer were found to be independent risk factors for poor DFS at 5 years.

CONCLUSION: We confirmed the results found in the previous 3-year survival analysis, the level of inferior mesenteric artery ligation does not affect OS, DSS and DFS at 5-year follow-up.

PMID:36335077 | DOI:10.1016/j.ejso.2022.10.017

Categories
Nevin Manimala Statistics

Microfluidic sperm sorting improves ICSI outcomes in patients with increased values of Double-Strand Breaks in sperm DNA

Rev Int Androl. 2022 Nov 2:S1698-031X(22)00090-5. doi: 10.1016/j.androl.2021.10.003. Online ahead of print.

ABSTRACT

BACKGROUND: Delays in embryo kinetics, implantation failures in ICSI treatments and recurrent miscarriages have been associated with high values of Double-Strand Breaks (DSB) in sperm DNA. While conventional methods for semen preparation have been shown to be inefficient reducing DSB values, Microfluidic Sperm Sorting (MSS) devices are promising tools to reduce this damage.

OBJECTIVE: To study the clinical utility of an MSS device in ICSI treatments when the male partner presents increased DSB values, as compared to the use of conventional methods based on sperm motility.

METHODS: This retrospective cohort study included 28 infertile couples undergoing ICSI treatments. Only couples where the male partner presented increased values of DSB were included. DSB values were evaluated in semen samples by the Neutral Comet assay. Couples performed a first ICSI cycle using conventional methods for semen preparation (Density Gradients and Swim-up) and a second ICSI cycle using the ZyMōt™ICSI (formerly named FertileChip®) microfluidic device. Embryology and clinical outcomes were compared between ICSI cycles.

RESULTS: Semen parameters and the number of obtained and fertilized oocytes did not show differences between ICSI rounds. Clinical outcomes were statistically better when MSS was used: the biochemical pregnancy rate increased 28.31%; the clinical pregnancy rate increased 35.56% and the number of live births increased 35.29%, as compared to the first ICSI cycle in this group of patients.

CONCLUSIONS: The ZyMōt™ICSI microfluidic device improved the reproductive outcomes in couples where the male partner presented increased DSB values, when compared to the use of conventional semen preparation techniques.

PMID:36335071 | DOI:10.1016/j.androl.2021.10.003