Tag: statistics

Pediatrics. 2022 Aug 26:e2022057346. doi: 10.1542/peds.2022-057346. Online ahead of print.

ABSTRACT

OBJECTIVES: Antibiotics are commonly administered during labor and delivery, and research has suggested that fetal exposure to antibiotics can increase risk for autism spectrum disorder (ASD). We assessed whether antibiotic exposure during labor and delivery increased the risk of ASD in the offspring.

METHODS: This retrospective cohort study included everyone who delivered a live singleton-term infant in British Columbia, Canada, between April 1, 2000, and December 31, 2014. This cohort included 569 953 deliveries. To examine the association among pregnant individuals being treated for the same indication, we studied a subcohort of those who tested positive for group B Streptococcus. Cox proportional hazards models were used to estimate unadjusted and adjusted hazard ratios in both cohorts. A sensitivity analysis was conducted using length of first stage of labor as a proxy measure for dose to assess for a dose-response relationship.

RESULTS: In this population-based study, antibiotic use during labor and delivery was not associated with an increased risk of ASD in offspring. The unadjusted and adjusted hazard ratios were 1.29 (95% confidence interval, 1.24-1.35) and 0.99 (0.94-1.04), respectively; and 1.07 (0.90-1.27) and 0.88 (0.74-1.05), respectively, in the group B Streptococcus-positive cohort. We observed no substantial difference in the association between antibiotic exposure and ASD depending on length of the first stage of labor.

CONCLUSIONS: Our findings suggest that concern for ASD should not factor into the clinical decision on whether to administer antibiotics during labor and delivery. Future research is needed to examine longer durations of prenatal antibiotic exposure.

PMID:36017659 | DOI:10.1542/peds.2022-057346

Palliat Support Care. 2022 Aug 26:1-12. doi: 10.1017/S1478951522000979. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to explore perceptions of the meaning of life among Korean patients living with advanced cancer.

METHOD: The study employed a mixed-methods design, and 16 participants were included in the analysis. Qualitative data gathered from in-depth interviews were analyzed using Colaizzi’s phenomenological method. Quantitative survey data were analyzed using descriptive statistics, the Mann-Whitney U test, the Kruskal-Wallis test, and Spearman’s ρ correlation.

RESULTS: Participants experienced both the existence of meaning and the will to find meaning in terms of four categories: “interpersonal relationships based on attachment and cohesion” (three themes – family as the core meaning of one’s life, supportive and dependent interconnectedness with significant others, and existential responsibility embedded in familism), “therapeutic relationships based on trust” (one theme – communication and trust between the patient and medical staff), “optimism” (two themes – positivity embodied through past experiences and a positive attitude toward the current situation), and “a sense of purpose with advanced cancer” (two themes – the will to survive and expectations for the near future). The meaning in life questionnaire (MLQ) and the purpose in life scale (PIL) showed a significant positive correlation tendency with the functional assessment of chronic illness therapy-spiritual well-being scale (FACIT-Sp). The patient health questionnaire (PHQ-9) showed significant negative correlation tendency with both the MLQ-presence of meaning (MLQ-PM) and PIL-Initiative (PIL-I) questionnaires.

SIGNIFICANCE OF RESULTS: Finding meaning in life helps advanced cancer patients realize their will to live. It also acts as a coping mechanism that palliates negative experiences in the fight against the disease. In particular, among advanced cancer patients in the Korean culture, the dynamics of relationships with family and medical staff was a key axis that instilled optimism and will to live. These results suggest that considering the meaning of life in advanced cancer patients by reflecting Korean culture in the treatment process improves the quality of care.

PMID:36017653 | DOI:10.1017/S1478951522000979

Immunopharmacol Immunotoxicol. 2022 Aug 26:1-7. doi: 10.1080/08923973.2022.2117629. Online ahead of print.

ABSTRACT

BACKGROUND: Immune checkpoint inhibitors (ICI) have revolutionized care in oncology with improved overall survival in several cancer populations. Nivolumab has recently been approved for use in patients with upper gastrointestinal cancers. We quantitatively summarized the efficacy and safety of Nivolumab use in patients with advanced esophageal, gastroesophageal, and gastric carcinoma compared to standard chemotherapy.

METHODS: Systemic search of electronic databases was performed to analyze phase III randomized controlled trials (RCTs) comparing Nivolumab versus standard chemotherapy in patients with advanced upper gastrointestinal cancers. Primary endpoints were overall survival (OS) and progression-free survival (PFS). Data were pooled using random effects model via RevMan 5.4 software.

RESULTS: Four RCTs with a total of 3,369 patients and a median follow-up of 13 months were included. The patients’ mean age was 61 ± 20 years, 74.6% were males, and 26% had ≥1% PD-L1 expression. Compared to the chemotherapy group, Nivolumab group had a significantly favorable OS and PFS [HR 0.81;95% CI (0.74, 0.89), P < 0.001], [HR 0.82;95% CI (0.69, 0.98), P = 0.03], respectively. Nivolumab significant effect was only in patients with ≥1% PD L1 expression [HR 0.72; 95% CI (0.58, 0.89), P < 0.001]. No statistical difference was detected between groups regarding serious adverse effects (AE) [OR 1.47; 95%CI (0.94,2.31), P = 0.09].

CONCLUSIONS: Compared to standard chemotherapy, the use of Nivolumab in patients with advanced esophageal, gastroesophageal, and gastric cancers is associated with improved overall and progression-free survival, with similar rates of AE and AE leading to death. The improvement in survival was significant in patients with ≥1% PD L1 expression.

PMID:36017642 | DOI:10.1080/08923973.2022.2117629

J Endourol. 2022 Aug 26. doi: 10.1089/end.2022.0214. Online ahead of print.

ABSTRACT

BACKGROUND: Magnetic resonance imaging-guided transurethral ultrasound ablation (TULSA) is under investigation for whole gland ablation of low and intermediate risk prostate cancer. The ideal method for post-TULSA bladder drainage via postoperative suprapubic tube (SPT) versus indwelling urethral catheter (UC) has not been established. The objective of this study was to evaluate urinary outcomes after whole gland TULSA, comparing postoperative SPT to UC.

MATERIALS AND METHODS: Two-institution, retrospective analysis of whole gland TULSA for men with grade group 1 and 2 prostate cancer. One institution placed SPT at the time of TULSA with clamp trials (day 10) and removal once voiding. The second placed UC until void trial (day 7). Outcomes included the International Prostate Symptom Score (IPSS), urinary bother score, catheter reinsertion, stricture, clean intermittent catheterization (CIC), and incontinence.

RESULTS: Forty-five patients (median age 67) were analyzed. The UC cohort (N=26) was older (P=0.007) than the SPT cohort (N=19) but with similar baseline prostate volumes, IPSS and urinary bother scores. Patients receiving UC had fewer days with catheter (P=0.013). Although UC patients suffered more lower urinary tract symptoms at one-month post-TULSA, there was no significant difference between IPSS scores at six months after surgery and at baseline regardless of urinary management strategy, though the UC group noted significantly decreased urinary bother. Rates of infection were similar between groups. Six strictures were observed overall with more in the SPT group, though the difference was not significant (4/19 [21.1%] SPT; 2/26 [7.7%] UC). At 6 months, incontinence rates were low and similar between groups (2/19 [10.5%] SPT; 4/26 [15.4%] UC) and only one patient (UC) required CIC.

CONCLUSIONS: Our overall findings suggest that SPT and UC are both acceptable options for postoperative bladder drainage following whole gland TULSA, with statistically similar rates of urinary complications but a slightly different side effect profile.

PMID:36017622 | DOI:10.1089/end.2022.0214

Expert Rev Vaccines. 2022 Aug 26. doi: 10.1080/14760584.2022.2117695. Online ahead of print.

ABSTRACT

BACKGROUND: Pregnant women have a low uptake of influenza vaccination, although being recommended as a priority.

RESEARCH DESIGN AND METHODS: We conducted a cross-sectional questionnaire survey in China from June to July 2021. Hierarchical regression analysis and structural equation modeling were performed based on the extended theory of planned behavior, in which attitudes, subjective norms, perceived behavioral control, and intention each affect the vaccine hesitancy; four variables of response efficacy, knowledge, vulnerability, and severity were added as extended dimensions; vaccination history played a moderator role in this model-to test the validity of the framework.

RESULTS: Totally, 1283 pregnant women participated in this study. The intention existed as a mediator between attitude [β_indirect=0.142 (95% confidence interval (CI): 0.084, 0.206), P<0.001], subjective norms [β_indirect=0.568 (95%CI: 0.424, 0.754), P<0.001], perceived behavioral control [β_indirect=0.070 (95%CI: 0.025, 0.118), P=0.004] and vaccine hesitancy. Further, the differences in indirect effect between the two dimensions of attitude (P<0.001), perceived behavioral control (P<0.001), and subjective norms were each statistically significant. Vaccination history did not moderate the association between attitude (P=0.679), subjective norms (P=0.645), and hesitancy.

CONCLUSIONS: The subjective norms dimension has a strong association with influenza vaccine hesitancy. Vaccination history had limited ability to reduce hesitancy during pregnancy.

PMID:36017619 | DOI:10.1080/14760584.2022.2117695

Clin Chem Lab Med. 2022 Aug 26. doi: 10.1515/cclm-2022-0635. Online ahead of print.

ABSTRACT

OBJECTIVES: Fibroblast growth factor 23 (FGF23) plays a key role in the pathophysiology of chronic kidney disease (CKD) and of the associated cardiovascular diseases, ranking on the crossroads of several evolving areas with a relevant impact on the health-care system (ageing, treatment of CKD and prevention from cardiovascular and renal events). In this review, we will critically appraise the overall issues concerning the clinical usefulness of FGF23 determination in CKD, focusing on the analytical performances of the methods, aiming to assess whether and how the clinical introduction of FGF23 may promote cost-effective health care policies in these patients.

CONTENT: Our comprehensive critical appraisal of the literature revealed that we are currently unable to establish the clinical usefulness of FGF23 measured by ELISA in CKD, as stability issues and suboptimal analytical performances are the major responsible for the release of misleading results. The meta-analytical approach has failed to report unambiguous evidence in face of the wide heterogeneity of the results from single studies.

SUMMARY AND OUTLOOK: Our review has largely demonstrated that the clinical usefulness depends on a thorough analytical validation of the assay. The recent introduction of chemiluminescent intact-FGF23 (iFGF23) assays licensed for clinical use, after passing a robust analytical validation, has allowed the actual assessment of preliminary risk thresholds for cardiovascular and renal events and is promising to capture the iFGF23 clinically relevant changes as a result of a therapeutic modulation. In this perspective, the analytical optimization of FGF23 determination may allow a marriage between physiology and epidemiology and a merging towards clinical outcomes.

PMID:36008874 | DOI:10.1515/cclm-2022-0635

BMC Musculoskelet Disord. 2022 Aug 26;23(1):813. doi: 10.1186/s12891-022-05763-2.

ABSTRACT

BACKGROUND: The greater likelihood of morbidity, mortality, length of hospital stays and poorer long-term outcomes as a result of surgical site infections secondary to spinal surgery makes prophylactic measures an imperative focus. Therefore, the aim of this review was to evaluate the available research related to the efficacy of different intraoperative irrigation techniques used in spinal surgery for surgical site infection (SSI) prophylaxis.

METHODS: We performed a comprehensive search using Ovid Medline, EMBASE, Web of Science and the Cochrane library pertaining to this topic. Our meta-analysis was conducted according to PRISMA guidelines. The inclusion criteria consist of spine surgeries with intraoperative use of any wound irrigation technique, comparison groups with a different intraoperative irrigation technique or no irrigation, SSI identified with bacterial cultures or clinically in the postoperative period, reported SSI rates. Data extracted from eligible studies included, but was not limited to, SSI rates, irrigation technique and control technique. Exclusion criteria consist of articles with no human subjects, reviews, meta-analyses and case control studies and no details about SSI identification or rates. Pooled risk ratios were calculated. A meta-analysis was performed with a forest plot to determine risk estimates’ heterogeneity with I² index, Q-statistic, and p value under a random-effects model. Funnel plot was used to assess publication bias. All databases were last checked on January, 2022. PROBAST tool was used to assess both risk of bias and applicability concerns.

RESULTS: After reviewing 1494 titles and abstracts, 18 articles met inclusion criteria. They included three prospective randomized-controlled trials, 13 retrospective cohort studies, two prospective cohort studies. There were 54 (1.8%) cases of SSIs in the povidone-iodine irrigation group (N = 2944) compared to 159 (4.6%) in the control group (N = 3408). Using intraoperative povidone-iodine wound irrigation produced an absolute risk reduction of 2.8%. Overall risk ratio was 0.32 (95% CI 0.20-0.53, p < 0.00001). In a global analysis, study heterogeneity and synthesizing mostly retrospective data were primary limitations.

CONCLUSION: The most evidence exists for povidone-iodine and has Level 2 evidence supporting SSI reduction during spinal surgery. Other antiseptic solutions such as dilute chlorhexidine lack published evidence in this patient population which limits the ability to draw conclusions related to its use in spinal surgery.

LEVEL OF EVIDENCE: II – Systematic Review with Meta-Analysis.

PMID:36008858 | DOI:10.1186/s12891-022-05763-2

BMC Pulm Med. 2022 Aug 25;22(1):323. doi: 10.1186/s12890-022-02118-4.

ABSTRACT

BACKGROUND: The mortality rate remains high among patients with coinfection with Pneumocystis pneumonia (PCP) and HIV. The timing for initiation of antiretroviral therapy (ART) after a diagnosis of moderate to severe PCP remains controversial, however. We therefore designed the present study to determine the optimal timing for ART initiation in AIDS-associated PCP (AIDS/PCP) patients.

METHODS: This was a multicenter, observational, prospective clinical trial. Eligible participants were recruited from 14 hospitals in mainland China, and assigned to an Early ART arm (initiation of ART ≤ 14 days after PCP diagnosis) and a Deferred ART arm (initiation of ART > 14 days after PCP diagnosis). The primary outcomes were death and the incidence of AIDS-defining events at week 48. The secondary outcomes were the changes in CD4+ T-cell counts from baseline values at weeks 12, 24, and 48, the virological suppression rate at week 24 and week 48, the rate of development of PCP-associated immune reconstitution inflammatory syndrome (PCP/IRIS), and the rate of adverse events over 48 weeks.

RESULTS: The present study was performed using the data of 363 participants, with 169 participants in the Early ART arm, and 194 participants in the Deferred ART arm. Immunological and virological outcomes were found to be similar in both treatment arms. At week 48, there were no significant differences for the incidence of mortality (20 vs. 26, p = 0.860), and AIDS-defining events (17 vs. 26, p = 0.412). Over 48 weeks, the rates of PCP/IRIS (2 vs. 3, p = 1.000), adverse events (70 vs. 72, p = 0.465), and grade 3 or 4 adverse events (28 vs. 34, p = 0.919) did not reach statistical significance. A significant difference observed between two study arms was that 11 participants (55.0%) in the Early ART arm compared to 23 participants (88.5%) in the Deferred ART arm (p = 0.026) succumbed before ART had ever been started.

CONCLUSIONS: Early ART initiation results in no increase in mortality, AIDS-defining events, IRIS, adverse events, and immunological or virological outcomes. These results support the early initiation of ART in patients with moderate to severe AIDS/PCP. Clinical trial registration The present trial was registered at Chinese Clinical Trial Registry (ChiCTR1900021195). Registered 1 February 2019, http://www.chictr.org.cn/showproj.aspx?proj=35362 .

PMID:36008855 | DOI:10.1186/s12890-022-02118-4

Virol J. 2022 Aug 25;19(1):137. doi: 10.1186/s12985-022-01869-0.

ABSTRACT

BACKGROUND: The purpose of this study was to evaluate the distributions of vaginal microbiome dysbiosis and human papillomavirus (HPV) subtypes in infertile women and explore the correlations of HPV infection and vaginal microbiome dysbiosis with infertility.

METHODS: In total, 1464 women aged 18-50 years were included in this study; 649 participants were included in the infertility group, and 815 participants were included in the normal group. The participants were tested for HPV, and their vaginal microecology was examined. The χ² test and Spearman regression were used for statistical analysis, and binary logistic regression was performed to identify the risk factors for infertility.

RESULTS: The patients in the infertility group were younger than those in the normal group, and the proportions of bacterial vaginosis and vaginal imbalance in the infertility group were significantly higher than those in the normal group. The incidence proportions of high-risk HPV types in the infertility group were significantly higher than those in the normal group, and the proportions of high-risk subtytes HPV16, HPV39, HV52, HPV56, and HPV68 were significantly higher in the infertility group than in the normal group. However, there were no significant differences in the incidences of low-risk HPV types. The incidence proportions of vaginal flora imbalance and HPV infection in the infertility group were significantly higher than those in the normal group. HPV16, HPV33, HPV51, HPV52and HPV58 infections were independent risk factors for infertility.

CONCLUSIONS: Vaginal microecological imbalance and HPV infection are directly related to infertility, and precautions should be taken.

PMID:36008847 | DOI:10.1186/s12985-022-01869-0

Malar J. 2022 Aug 25;21(1):245. doi: 10.1186/s12936-022-04273-9.

ABSTRACT

BACKGROUND: The goal of this study was to understand the epidemiological characteristics of imported malaria in Shanghai specifically during the epidemic period of novel corona-virus pneumonia (COVID-19), to provide a reference for preventing the transmission of imported malaria after this disease had been previously eliminated.

METHODS: The data of malaria cases reported in Shanghai from 2020 to 2021 were obtained from the China Information System for Disease Control and Prevention (CISDCP) and the Information System for Parasitic Disease Control and Prevention (ISPDCP). The characteristics of demographic and epidemiological distribution, travel-related information, diagnosis information, regions of infection acquisition and disposal information of epidemic situation were analysed with descriptive statistics.

RESULTS: A total of 112 cases of malaria were reported in Shanghai from January 2020 to December 2021. There were 18 cases and 94 cases in 2020 and 2021, respectively, reaching the lowest and highest levels in the past 10 years. The incidence of malaria associated with seasons had an increasing trend (χ² = 81.143, P < 0.05). These cases included Plasmodium falciparum (97, 86.61%), Plasmodium vivax (4, 3.57%), Plasmodium ovale (8, 7.14%) and Plasmodium malariae (3, 2.68%). The median age of patients with malaria was 38.0 years, the majority of these individuals were males (109, 97.32%), and most of them were labour personnel (93, 83.04%). Of the reported cases, 8 of these individuals (7.14%) reported experiencing malaria symptoms before their arrival in China after their stay overseas; 97 of these individuals (86.61%) reported experiencing symptoms within 14 days after their initial arrival from overseas; 15 of these individuals (13.39%) were diagnosed with ‘severe malaria’; and 4 of these individuals (3.57%) were also diagnosed with COVID-19. All cases were imported from Africa, and there were no indigenous cases and deaths.

CONCLUSION: Due to the impact of COVID-19, the number of imported malaria cases in Shanghai had greatly increased; however, prevention and control measures for imported malaria could be implemented to prevent re-transmission of this condition. Considering that the number of individuals returning from overseas labour is likely to increase in the next few years, it is necessary to strengthen the surveillance of imported malaria and to review the protocol for potential epidemic situations. Together, these measures could support the maintation of free-malaria status in Shanghai.

PMID:36008837 | DOI:10.1186/s12936-022-04273-9