Tag: statistics

BMC Vet Res. 2023 Mar 3;19(1):57. doi: 10.1186/s12917-023-03609-0.

ABSTRACT

BACKGROUND: Epilepsy is the most common chronic neurological disease in dogs. More than two-thirds of these patients suffer from associated behavioural comorbidities. The latter could have their origin in partially overlapping pathomechanisms, with the intestinal microbiome as a potential key link between them. The current arsenal of drugs for epilepsy management remains limited. Most canine patients continue to have seizures despite treatment and the occurrence of comorbidities is not sufficiently addressed, limiting quality of life of affected dogs and owners. Therefore, novel additional epilepsy management options are urgently needed. The microbiome-gut-brain axis may serve as a new target for the development of innovative multimodal therapeutic approaches to overcome current shortcomings in epilepsy management.

METHODS: A six-month prospective, randomised, double-blinded, placebo-controlled, crossover, dietary trial was designed to investigate the potential of the psychobiotic Bifidobacterium longum on behavioural comorbidities in canine epilepsy. Seizure semiology will be evaluated as a secondary outcome measure. Thirty-four privately owned dogs are planned to be included in the ongoing study meeting the following inclusion criteria: Dogs displaying increased anxiety/fear behaviour since the start of the idiopathic epilepsy. Tier II confidence level of the International Veterinary Epilepsy Task Force for the diagnosis of idiopathic epilepsy, with a maximum seizure interval of 3 month and a minimum of three generalised seizures within that period and chronically treated with at least one antiseizure drug without improvement in seizure frequency Each dog will receive the allocated supplement (probiotic vs. placebo) alongside its normal diet for a 3-month period. After a three-week wash out period, the second phase starts by administering the respective other supplement for another 3 months.

DISCUSSION: The current study considers modern high-quality standards for epilepsy medication trials. Common biasing effects should be limited to a possible minimum (regression-to-the mean effect, placebo effect, observer effect), ensuring a high validity and accuracy of the acquired results, thus enabling a representative nature of the efficacy of Bifidobacterium longum as add-on supplement for dogs suffering from epilepsy and its comorbidities. This publication should provide a description of the study procedure and data acquisition methods, including prognosed statistical analysis.

PMID:36864510 | DOI:10.1186/s12917-023-03609-0

Cardiooncology. 2023 Mar 2;9(1):12. doi: 10.1186/s40959-023-00162-5.

ABSTRACT

BACKGROUND: This study aimed to evaluate the association between preoperative hs-cTnI and long-term mortality and major adverse cardiovascular events (MACE) in colorectal cancer patients.

METHODS: This single-center retrospective cohort study included 1105 consecutive colorectal cancer patients who received tumor resection surgery between January 2018 and June 2020. Inclusion criteria were an age ≥ 18 years and had been tested for hs-cTnI on admission within 7 days prior to tumor resection surgery. Exclusion criteria were emergent surgery, failure to received tumor resection surgery, hospital death, there was clinical evidence of unstable coronary artery disease or pulmonary embolism occurred before operation according to medical record. The primary endpoint was all-cause death. Secondary endpoint was major adverse cardiovascular events (MACE).

RESULTS: A total of 1105 patients were enrolled: 1032 with normal hs-cTnI and 73 with elevated hs-cTnI. The mean follow-up was 24.4 ± 10.8 months, 176 patients died and 39 patients met MACE. In the elevated troponin group, 50%, 32.1% and 17.9% died from cancer, cardiovascular and other causes, while those in the normal troponin group were 75.7%, 2% and 22.3%, there was statistical difference between 2 groups (P < 0.001). Patients with elevated preoperative hs-cTnI had significantly higher mortality (P < 0.001) and more MACE (P < 0.001) compared with those with normal hs-cTnI. A propensity-matching analysis were performed, resulting in 151 patients with normal hs-cTnI and 60 patients with elevated hs-cTnI. The matched population had the similar results for all-cause death (P = 0.009) and MACE (P = 0.001). The results were consistent after further excluding 147 patients who had received chemoradiotherapy prior to surgery in subgroup analysis. The results of multivariate Cox regression analysis shown that hs-cTnI was one of the best predictors for all-cause death (hazard ratio [HR] 2.278; 95% confidence interval [CI] 1.19-4.361) and MACE (HR, 3.523; 95%CI, 1.477-8.403) in total populations, similar results were found in subgroup analysis.

CONCLUSIONS: Colorectal cancer patients without myocardial ischemia manifestation but with elevated hs-cTnI prior to tumor resection surgery were at increased risk for long-term all-cause death and MACE, irrespective of whether they have received chemoradiotherapy prior to surgery.

PMID:36864502 | DOI:10.1186/s40959-023-00162-5

Trials. 2023 Mar 2;24(1):159. doi: 10.1186/s13063-023-07157-8.

ABSTRACT

BACKGROUND: Recruiting participants for lifestyle programmes is known to be challenging. Insights into recruitment strategies, enrolment rates and costs are valuable but rarely reported. We provide insight into the costs and results of used recruitment strategies, baseline characteristics and feasibility of at-home cardiometabolic measurements as part of the Supreme Nudge trial investigating healthy lifestyle behaviours. This trial was conducted during the COVID-19 pandemic, requiring a largely remote data collection approach. Potential sociodemographic differences were explored between participants recruited through various strategies and for at-home measurement completion rates.

METHODS: Participants were recruited from socially disadvantaged areas around participating study supermarkets (n = 12 supermarkets) across the Netherlands, aged 30-80 years, and regular shoppers of the participating supermarkets. Recruitment strategies, costs and yields were logged, together with completion rates of at-home measurements of cardiometabolic markers. Descriptive statistics are reported on recruitment yield per used method and baseline characteristics. We used linear and logistic multilevel models to assess the potential sociodemographic differences.

RESULTS: Of 783 recruited, 602 were eligible to participate, and 421 completed informed consent. Most included participants were recruited via letters/flyers at home (75%), but this strategy was very costly per included participant (89 Euros). Of paid strategies, supermarket flyers were the cheapest (12 Euros) and the least time-invasive (< 1 h). Participants who completed baseline measurements (n = 391) were on average 57.6 (SD 11.0) years, 72% were female and 41% had high educational attainment, and they often completed the at-home measurements successfully (lipid profile 88%, HbA1c 94%, waist circumference 99%). Multilevel models suggested that males tended to be recruited more often via word-of-mouth (OR_females 0.51 (95%CI 0.22; 1.21)). Those who failed the first attempt at completing the at-home blood measurement were older (β 3.89 years (95% CI 1.28; 6.49), whilst the non-completers of the HbA1c (β – 8.92 years (95% CI – 13.62; – 4.28)) and LDL (β – 3.19 years (95% CI – 6.53; 0.09)) were younger.

CONCLUSIONS: Supermarket flyers were the most cost-effective paid strategy, whereas mailings to home addresses recruited the most participants but were very costly. At-home cardiometabolic measurements were feasible and may be useful in geographically widespread groups or when face to face contact is not possible.

TRIAL REGISTRATION: Dutch Trial Register ID NL7064, 30 May 2018, https://trialsearch.who.int/Trial2.aspx?TrialID=NTR7302.

PMID:36864494 | DOI:10.1186/s13063-023-07157-8

Ultrasound Obstet Gynecol. 2023 Mar 2. doi: 10.1002/uog.26186. Online ahead of print.

ABSTRACT

OBJECTIVES: This study aimed to evaluate the prenatal characteristics of double aortic arch (DAA), assess the relative size of the arches and their growth during pregnancy, describe associated cardiac, extracardiac and chromosomal/genetic abnormalities and review postnatal presentation and clinical outcome.

METHODS: All fetuses with a confirmed diagnosis of DAA seen in five specialized referral centers between November 2012 and November 2019 were retrospectively identified from the hospitals’ fetal databases. Fetal echocardiographic findings, intracardiac and extracardiac abnormalities, genetic defects, computed tomography (CT) findings and postnatal clinical presentation and outcome were evaluated.

RESULTS: A total of 79 fetal cases of DAA were included. Of the whole cohort, 48.6% had an atretic left aortic arch (LAA) postnatally, with 5.1% being atretic at 1^st fetal scan and diagnosed antenatally as right aortic arch (RAA). Among those who had CT scan, the LAA was atretic in 55.7%. DAA was an isolated abnormality in 91.1% of the cases, 8.9% had intracardiac (ICA) and 2.5% had extracardiac abnormalities (ECA). Among those tested, 11.5% had genetic abnormalities and specifically 22q11 microdeletion was identified in 3.8% of the patients. At a median follow up of 993.5 days, 42.5% of the patients had developed symptoms of tracheo-esophageal compression (5.5% during the first month of life) and 56.2% underwent intervention. Statistical analysis using Chi-square test showed no statistically significant correlation between patency of both aortic arches or not and need for intervention (P-value 0.134), development of vascular ring symptoms (P-value 0.350) or evidence of airway compression on CT (P-value 0.193) CONCLUSIONS: Most DAA cases can be easily diagnosed in mid-gestation as both arches are patent with a dominant RAA. However, posnatally the LAA has become atretic in approximately half of the cases, supporting the theory of differential growth during pregnancy. DAA is usually an isolated abnormality; however, a thorough assessment is required, to exclude ICA and ECA and to discuss invasive prenatal genetic testing. Postnatally, early clinical assessment is needed, and CT scan should be considered, irrespective of the presence of symptoms or not. This article is protected by copyright. All rights reserved.

PMID:36864493 | DOI:10.1002/uog.26186

Microbiome. 2023 Mar 2;11(1):35. doi: 10.1186/s40168-023-01473-6.

ABSTRACT

BACKGROUND: Arctic snowpack microbial communities are continually subject to dynamic chemical and microbial input from the atmosphere. As such, the factors that contribute to structuring their microbial communities are complex and have yet to be completely resolved. These snowpack communities can be used to evaluate whether they fit niche-based or neutral assembly theories.

METHODS: We sampled snow from 22 glacier sites on 7 glaciers across Svalbard in April during the maximum snow accumulation period and prior to the melt period to evaluate the factors that drive snowpack metataxonomy. These snowpacks were seasonal, accumulating in early winter on bare ice and firn and completely melting out in autumn. Using a Bayesian fitting strategy to evaluate Hubbell’s Unified Neutral Theory of Biodiversity at multiple sites, we tested for neutrality and defined immigration rates at different taxonomic levels. Bacterial abundance and diversity were measured and the amount of potential ice-nucleating bacteria was calculated. The chemical composition (anions, cations, organic acids) and particulate impurity load (elemental and organic carbon) of the winter and spring snowpack were also characterized. We used these data in addition to geographical information to assess possible niche-based effects on snow microbial communities using multivariate and variable partitioning analysis.

RESULTS: While certain taxonomic signals were found to fit the neutral assembly model, clear evidence of niche-based selection was observed at most sites. Inorganic chemistry was not linked directly to diversity, but helped to identify predominant colonization sources and predict microbial abundance, which was tightly linked to sea spray. Organic acids were the most significant predictors of microbial diversity. At low organic acid concentrations, the snow microbial structure represented the seeding community closely, and evolved away from it at higher organic acid concentrations, with concomitant increases in bacterial numbers.

CONCLUSIONS: These results indicate that environmental selection plays a significant role in structuring snow microbial communities and that future studies should focus on activity and growth. Video Abstract.

PMID:36864462 | DOI:10.1186/s40168-023-01473-6

BMC Public Health. 2023 Mar 2;23(1):419. doi: 10.1186/s12889-023-15331-5.

ABSTRACT

BACKGROUND: Social inequality in smoking remains an important public health issue. Upper secondary schools offering vocational education and training (VET) comprise more students from lower socioeconomic backgrounds and have higher smoking prevalence than general high schools. This study examined the effects of a school-based multi-component intervention on students’ smoking.

METHODS: A cluster randomized controlled trial. Eligible participants were schools offering VET basic courses or preparatory basic education in Denmark, and their students. Schools were stratified by subject area and eight schools were randomly allocated to intervention (1,160 invited students; 844 analyzed) and six schools to control (1,093 invited students; 815 analyzed). The intervention program comprised smoke-free school hours, class-based activities, and access to smoking cessation support. The control group was encouraged to continue with normal practice. Primary outcomes were daily cigarette consumption and daily smoking status at student level. Secondary outcomes were determinants expected to impact smoking behavior. Outcomes were assessed in students at five-month follow-up. Analyses were by intention-to-treat and per protocol (i.e., whether the intervention was delivered as intended), adjusted for covariates measured at baseline. Moreover, subgroup analyses defined by school type, gender, age, and smoking status at baseline were performed. Multilevel regression models were used to account for the cluster design. Missing data were imputed using multiple imputations. Participants and the research team were not blinded to allocation.

RESULTS: Intention-to-treat analyses showed no intervention effect on daily cigarette consumption and daily smoking. Pre-planned subgroup analyses showed statistically significant reduction in daily smoking among girls compared with their counterparts in the control group (OR = 0.39, 95% CI: 0.16, 0.98). Per-protocol analysis suggested that schools with full intervention had higher benefits compared with the control group (daily smoking: OR = 0.44, 95% CI: 0.19, 1.02), while no marked differences were seen among schools with partial intervention.

CONCLUSION: This study was among the first to test whether a complex, multicomponent intervention could reduce smoking in schools with high smoking risk. Results showed no overall effects. There is a great need to develop programs for this target group and it is important that they are fully implemented if an effect is to be achieved.

TRIAL REGISTRATION: https://www.isrctn.com/ISRCTN16455577 , date of registration 14/06/2018.

PMID:36864450 | DOI:10.1186/s12889-023-15331-5

J Orthop Surg Res. 2023 Mar 2;18(1):157. doi: 10.1186/s13018-023-03605-y.

ABSTRACT

BACKGROUND: Little published data currently exist regarding the potential relationships between spondylolisthesis, mismatch deformity, and clinical outcomes following total knee arthroplasty (TKA). We hypothesize that preexisting spondylolisthesis will result in decreased functional outcomes after TKA.

METHODS: This retrospective cohort comparison of 933 TKAs was performed between January 2017 and 2020. TKAs were excluded if they were not performed for primary osteoarthritis (OA) or if preoperative lumbar radiographs were unavailable/inadequate to measure the degree of spondylolisthesis. Ninety-five TKAs were subsequently available for inclusion and divided into two groups: those with spondylolisthesis and those without. Within the spondylolisthesis cohort, pelvic incidence (PI) and lumbar lordosis (LL) were calculated on lateral radiographs to determine the difference (PI-LL). Radiographs with PI-LL > 10° were then categorized as having mismatch deformity (MD). The following clinical outcomes were compared between the groups: need for manipulation under anesthesia (MUA), total postoperative arc of motion (AOM) both pre-MUA or post-MUA/revision, incidence of flexion contracture, and a need for later revision.

RESULTS: Forty-nine TKAs met the spondylolisthesis criteria, while 44 did not have spondylolisthesis. There were no significant differences in gender, body mass index, preoperative knee range of motion (ROM), preoperative AOM, or opiate use between the groups. TKAs with spondylolisthesis and concomitant MD were more likely to have MUA (p = 0.016), ROM < 0-120 (p < 0.014), and a decreased AOM (p < 0.02) without interventions.

CONCLUSION: Preexisting spondylolisthesis by itself may not have adverse effect clinical results following TKA. However, spondylolisthesis increases the likelihood of developing MD. In those with both spondylolisthesis and concomitant mismatch deformities, patients had statistically and clinically significantly decreased in postoperative ROM/AOM and increased need for MUA. Surgeons should consider clinical/radiographic assessments of patients with chronic back pain who present for total joint arthroplasty.

LEVEL OF EVIDENCE: Level 3.

PMID:36864440 | DOI:10.1186/s13018-023-03605-y

J Orthop Surg Res. 2023 Mar 2;18(1):158. doi: 10.1186/s13018-023-03652-5.

ABSTRACT

BACKGROUND: Regarding the increasing adoption of oblique lateral interbody fusion (OLIF) for treating degenerative lumbar disorders, we aimed to evaluate whether OLIF, one of the options for anterolateral approach lumbar interbody fusion, demonstrate clinical superiority over anterior lumbar interbody fusion (ALIF) or posterior approach, represented by transforaminal lumbar interbody fusion (TLIF).

METHODS: Patients who received ALIF, OLIF, and TLIF for symptomatic degenerative lumbar disorders during the period 2017-2019 were identified. Radiographic, perioperative, and clinical outcomes were recorded and compared during 2-year follow-up.

RESULTS: A total of 348 patients with 501 correction levels were enrolled in the study. Fundamental sagittal alignment profiles were substantially improved at 2-year follow-up, particularly in the anterolateral approach (A/OLIF) group. The Oswestry disability index (ODI) and EuroQol-5 dimension (EQ-5D) in the ALIF group were superior when compared to the OLIF and TLIF group 2-year following surgery. However, comparisons of VAS-Total, VAS-Back, and VAS-Leg revealed no statistically significance across all approaches. TLIF demonstrated highest subsidence rate of 16%, while OLIF had least blood loss and was suitable for high body mass index patients.

CONCLUSIONS: Regarding treatment for degenerative lumbar disorders, ALIF of anterolateral approach demonstrated superb alignment correction and clinical outcome. Comparing to TLIF, OLIF possessed advantage in reducing blood loss, restoring sagittal profiles and the accessibility at all lumbar level while simultaneously achieving comparable clinical improvement. Patient selection in accordance with baseline conditions, and surgeon preference both remain crucial issues circumventing surgical approach strategy.

PMID:36864438 | DOI:10.1186/s13018-023-03652-5

BMC Public Health. 2023 Mar 3;23(1):282. doi: 10.1186/s12889-023-15180-2.

ABSTRACT

BACKGROUND: This study aimed to look at emotions perceived about the attributes, prevention, diagnosis, and treatment of infectious diseases related to coronavirus disease (COVID-19) that were widespread across the world and identify their relevance to knowledge about infectious diseases and preventative behaviors.

METHODS: Texts to measure emotional cognition were selected through a pre-test, and 282 people were chosen as participants based on the survey conducted for 20 days from August 19 to August 29, 2020, created with Google Forms. IBM SPSS Statistics 25.0 was used for the primary analysis, and the SNA package in R (version 4.0.2) was utilized to conduct the network analysis.

RESULTS: It was found that universal negative emotions such as feeling “anxious” (65.5%), “afraid” (46.1%), and “scared” (32.7%) commonly appeared among most people. Also, they were found to be feeling both positive (“caring” [42.3%] and “strict” [28.2%]) and negative (“frustrating” [39.1%] and “isolated” [31.0%]) emotions about efforts to prevent and curb the spread of COVID-19. In terms of emotional cognition for the diagnosis and treatment of such diseases, “reliable” (43.3%) took the biggest ratio among the replies. The level of understanding about infectious diseases showed differences in emotional cognition, thereby affecting people’s emotions. However, no differences were found in the practice of preventative behaviors.

CONCLUSIONS: Emotions associated with cognition in the context of pandemic infectious diseases have been found to be mixed. Furthermore, it can be seen that feelings vary depending on the degree of understanding of the infectious disease.

PMID:36864419 | DOI:10.1186/s12889-023-15180-2

BMC Pregnancy Childbirth. 2023 Mar 2;23(1):134. doi: 10.1186/s12884-023-05438-3.

ABSTRACT

BACKGROUND: The outcome of in vitro fertilization-embryo transfer (IVF) is often determined according to follicle and estradiol levels following gonadotropin stimulation. In previous studies, although most of them analyzed the estrogen level from ovaries or the average estrogen level of a single follicle, there was no study on the ratio of estrogen increase, which was also correlated with pregnancy outcomes in the clinic. This study aimed to make timely adjustments to follow-up medication to improve clinical outcomes based on the potential value of estradiol growth rate.

METHODS: We comprehensively analyzed estrogen growth during the entire ovarian stimulation period. Serum estradiol levels were measured on the day of gonadotropin treatment (Gn1), five days later (Gn5), eight days later (Gn8), and on the trigger day (HCG). This ratio was used to determine the increase in estradiol levels. According to the ratio of estradiol increase, the patients were divided into four groups: A1 (Gn5/Gn1 ≤ 6.44), A2 (6.44 < Gn5/Gn1 ≤ 10.62), A3 (10.62 < Gn5/Gn1 ≤ 21.33), and A4 (Gn5/Gn1 > 21.33); B1 (Gn8/Gn5 ≤ 2.39), B2 (2.39 < Gn8/Gn5 ≤ 3.03), B3 (3.03 < Gn8/Gn5 ≤ 3.84), and B4 (Gn8/Gn5 > 3.84). We analyzed and compared the relationship between data in each group and pregnancy outcomes.

RESULTS: In the statistical analysis, the estradiol levels of Gn5 (P = 0.029, P = 0.042), Gn8 (P < 0.001, P = 0.001), and HCG (P < 0.001, P = 0.002), as well as Gn5/Gn1 (P = 0.004, P = 0.006), Gn8/Gn5 (P = 0.001, P = 0.002), and HCG/Gn1 (P < 0.001, P < 0.001) both had clinical guiding significance, and lower one significantly reduced the pregnancy rate. The outcomes were positively linked to groups A (P = 0.036, P = 0.043) and B (P = 0.014, P = 0.013), respectively. The logistical regression analysis revealed that group A1 (OR = 0.376 [0.182-0.779]; P = 0.008*, OR = 0.401 [0.188-0.857]; P = 0.018*) and B1 (OR = 0.363 [0.179-0.735]; P = 0.005*, OR = 0.389 [0.187-0.808]; P = 0.011*) had opposite influence on outcomes.

CONCLUSION: Maintaining a serum estradiol increase ratio of at least 6.44 on Gn5/Gn1 and 2.39 on Gn8/Gn5 may result in a higher pregnancy rate, especially in young people.

PMID:36864417 | DOI:10.1186/s12884-023-05438-3