Tag: statistics

Trials. 2024 Mar 6;25(1):169. doi: 10.1186/s13063-024-08011-1.

ABSTRACT

BACKGROUND: Good vision highly depends on the transparency of the cornea, which is the “windscreen” of the eye. In fact, corneal blindness due to transparency loss is the second most common cause of blindness worldwide, and corneal transplantation is the main cure. Importantly, the cornea is normally avascular but can secondarily be invaded by pathological (blood and lymphatic) vessels due to severe inflammation, and the survival prognosis of a corneal graft mainly depends on the preoperative vascular condition of the recipient’s cornea. Whereas transplants placed into avascular recipient beds enjoy long-term survival rates of > 90%, survival rates significantly decrease in pathologically pre-vascularized, so-called high-risk recipients, which account for around 10% of all performed transplants in Germany and > 75% in lower and middle-income countries worldwide.

METHODS: This parallel-grouped, open-randomized, multicenter, prospective controlled exploratory investigator-initiated trial (IIT) intends to improve graft survival by preconditioning pathologically vascularized recipient corneas by (lymph)angioregressive treatment before high-risk corneal transplantation. For this purpose, corneal crosslinking (CXL) will be used, which has been shown to potently regress corneal blood and lymphatic vessels. Prior to transplantation, patients will be randomized into 2 groups: (1) CXL (intervention) or (2) no pretreatment (control). CXL will be repeated once if insufficient reduction of corneal neovascularization should be observed. All patients (both groups) will then undergo corneal transplantation. In the intervention group, remaining blood vessels will be additionally regressed using fine needle diathermy (on the day of transplantation). Afterwards, the incidence of graft rejection episodes will be evaluated for 24 months (primary endpoint). Overall graft survival, as well as regression of corneal vessels and/or recurrence, among other factors, will be analyzed (secondary endpoints).

DISCUSSION: Based on preclinical and early pilot clinical evidence, we want to test the novel concept of temporary (lymph)angioregressive pretreatment of high-risk eyes by CXL to promote subsequent corneal graft survival. So far, there is no evidence-based approach to reliably improve graft survival in the high-risk corneal transplantation setting available in clinical routine. If successful, this approach will be the first to promote graft survival in high-risk transplants. It will significantly improve vision and quality of life in patients suffering from corneal blindness.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05870566. Registered on 22 May 2023.

PMID:38448965 | DOI:10.1186/s13063-024-08011-1

Diabetol Metab Syndr. 2024 Mar 6;16(1):62. doi: 10.1186/s13098-024-01289-w.

ABSTRACT

OBJECTIVES: we performed this meta- analysis to investigate the impact of insulin receptor substrate 1 (IRS1) gene rs1801278 on susceptibility to gestational diabetes mellitus (GDM).

METHODS: The pooled odds ratio (OR) and 95% confidence interval (95% CI) were calculated, and p value is used to determine statistical significance. Sensitivity analysis was performed under three models (dominant, recessive and allele model), and the pooled ORs and 95%CI were calculated. Funnel plots and Begger’s regression test were employed to test the publication bias.

RESULTS: The meta-analysis included 4777 participants (2116 cases and 2661 controls). The IRS1 rs1801278 (C/T) were not significant associated with GDM risk under the dominant and allele models, OR (95%CI) = 1.22 (0.88-1.70) and 1.24 (0.91-1.68), respectively (both p values were more than 0.05). But we also found the IRS1 rs1801278 (C/T) were significant associated with GDM risk under the recessive model, OR (95%CI) = 0.37 (0.16-0.86), p = 0.030. Our results showed that none of the studies affected the quality of the pooled OR. We also found no significant publication bias existed in this meta study for three genetic models, P_{TT + CT vs. CC} = 0.445; P_{CC+CT vs. TT}= 0.095; P_{C vs. T} = 0.697.

CONCLUSION: this meta-analysis indicated that IRS1 rs1801278 (C/T) was associated with the GDM risk under the recessive model but was not associated with the GDM risk under dominant and allele models.

PMID:38448958 | DOI:10.1186/s13098-024-01289-w

Antimicrob Resist Infect Control. 2024 Mar 6;13(1):29. doi: 10.1186/s13756-024-01385-6.

ABSTRACT

BACKGROUND: Antimicrobial stewardship programmes are needed in long-term care facilities (LTCFs) to tackle antimicrobial resistance. We aimed to identify factors associated with antibiotic use in LTCFs. Such information would be useful to guide antimicrobial stewardship programmes.

METHOD: We conducted a systematic review of studies retrieved from PubMed, Cochrane Library, Embase, APA PsycArticles, APA PsycINFO, APA PsycTherapy, ScienceDirect and Web of Science. We included quantitative studies that investigated factors associated with antibiotic use (i.e., antibiotic prescribing by health professionals, administration by LTCF staff, or use by residents). Participants were LTCF residents, their family, and/or carers. We performed a qualitative narrative synthesis of the findings.

RESULTS: Of the 7,591 screened records, we included 57 articles. Most studies used a longitudinal design (n = 34/57), investigated resident-level (n = 29/57) and/or facility-level factors (n = 32/57), and fewer prescriber-level ones (n = 8/57). Studies included two types of outcome: overall volume of antibiotic prescriptions (n = 45/57), inappropriate antibiotic prescription (n = 10/57); two included both types. Resident-level factors associated with a higher volume of antibiotic prescriptions included comorbidities (5 out of 8 studies which investigated this factor found a statistically significant association), history of infection (n = 5/6), potential signs of infection (e.g., fever, n = 4/6), positive urine culture/dipstick results (n = 3/4), indwelling urinary catheter (n = 12/14), and resident/family request for antibiotics (n = 1/1). At the facility-level, the volume of antibiotic prescriptions was positively associated with staff turnover (n = 1/1) and prevalence of after-hours medical practitioner visits (n = 1/1), and negatively associated with LTCF hiring an on-site coordinating physician (n = 1/1). At the prescriber-level, higher antibiotic prescribing was associated with high prescription rate for antibiotics in the previous year (n = 1/1).

CONCLUSIONS: Improving infection prevention and control, and diagnostic practices as part of antimicrobial stewardship programmes remain critical steps to reduce antibiotic prescribing in LTCFs. Once results confirmed by further studies, implementing institutional changes to limit staff turnover, ensure the presence of a professional accountable for the antimicrobial stewardship activities, and improve collaboration between LTCFs and external prescribers may contribute to reduce antibiotic prescribing.

PMID:38448955 | DOI:10.1186/s13756-024-01385-6

BMC Nurs. 2024 Mar 6;23(1):164. doi: 10.1186/s12912-024-01806-2.

ABSTRACT

BACKGROUND: Delayed recognition of compartment syndrome can result in devastating consequences such as the need for amputation or even death. Nurses are at the frontline of patient care and they must have a high index of suspicion for compartment syndrome. Even though nurses’ knowledge about the prevention of compartment syndrome is important, there are no studies in Ethiopia. Therefore this study aims to assess the knowledge and associated factors of nurses towards the prevention of post-traumatic compartment syndrome.

METHOD: An institutional-based cross-sectional study was conducted among 410 nurses from 26 April to 25 May 2023 at five Comprehensive Specialized Hospital. A stratified sampling technique was employed to recruit the required participants for the study. The data were collected using a structured self-administered questionnaire. The descriptive statistics were presented in text and tables. Analytical analysis schemes including bivariable and multivariable logistic regression were computed considering P-value < 0.05 to identify statistically significant factors.

RESULT: Nearly three- fifths (61.6%; 95% CI: 56.7 to 66.3) of nurses had adequate knowledge and significantly associated with being male (AOR: 1.615, 95% CI: 1.050-2.485), nurse use of guidelines (AOR: 2.079, 95% CI: 1.307-3.307), nurses they have been trained (AOR = 1.650; 95 CI: 1.063-2.562), and nurses’ who had more than 15 years’ (AOR: 4.207, 95 CI: 1.762-10.045) experience had good knowledge with respect to prevention of compartment syndrome than the counterparts.

CONCLUSION: Even though nurses’ knowledge regarding the prevention of post-traumatic compartment syndrome was found to be good, Diligent nursing assessment and monitoring of clinical signs should be critically performed. So, it is better to strengthen training, equip wards with standardized guidelines, and create a safe working environment should be routine activities.

PMID:38448942 | DOI:10.1186/s12912-024-01806-2

BMC Cancer. 2024 Mar 6;24(1):309. doi: 10.1186/s12885-024-12047-6.

ABSTRACT

BACKGROUND: Granulosa Cell Tumors (GCT) are considered the most frequent type of sex-cord stromal tumors. These tumors constitute 3-6% of neoplasms of the ovaries. GCTs are divided into 2 types: Juvenile GCT (JGCT) and Adult GCT (AGCT). Most patients are diagnosed early in the course of the disease and tend to have a favorable prognosis. In the surgical treatment of GCT, two main factors play role in the determination of feasibility of the surgery: age and tumor stage.

METHODS: A retrospective study was conducted on 65 consecutive female patients diagnosed with ovarian GCT at different hospitals across Lebanon who were referred to the National Institute of Pathology, Beirut-Lebanon, between January 2000 and January 2020. Then, they were divided according to types: adult versus juvenile type. Statistical analysis was carried out using Stata, version 16.

RESULTS: The incidence of GCT in a Lebanese population was 16.2 per million per year. The mean age of the studied population was 55.6 years. AGCT was the most common with a prevalence of 91% versus 19% for JGCT. Also, inhibine (the most important immunomarker) was found in 77.2% of adult cases. High mitotic index and high tumor size which are predictors for poor prognosis were respectively 20% and 36.9%. Concerning the histopathological features, Grooved nuclei and Exner bodies were less frequently observed in juvenile type (16.7% for both) compared to adult type (36.9%). Most patients with GCT were diagnosed in the early course of disease mainly due to the manifestation of the symptoms as abdominal pain, postmenopausal bleeding or intermenstrual bleeding, and the good diagnosis and screening practices in Lebanon. Regarding the recurrent cases, a significant correlation with high mitotic index (76.9%), high tumor size (92.3%) and advanced stage (46% for stage 3 and 46% for stage 4) was found with a p < 0.05.

CONCLUSIONS: The incidence of GCT in the Lebanese population is 16.2 per million per year. The majority of patients with GCT in Lebanon are of Adult type representing around 90% of cases. Older age, high mitotic index and big tumor size are predictors for poor outcomes.

PMID:38448917 | DOI:10.1186/s12885-024-12047-6

BMC Med Educ. 2024 Mar 6;24(1):244. doi: 10.1186/s12909-024-05251-2.

ABSTRACT

BACKGROUND: The systems approach has been used to evaluate higher education and explores inputs, transformation process, and outputs of a system that is also influenced by environmental factors such as COVID-19. The COVID-19 pandemic shifted many college students to different learning modes, changing their university experience. This study evaluated dietetics students’ education experiences and characteristics in the latter period (spring 2022) of the COVID-19 pandemic using the systems approach.

METHODS: Researchers developed and distributed an electronic survey to all 215 US-based Didactic Program in Dietetics (DPD) directors during March to May 2022 to forward to their students. Researchers calculated descriptive statistics for variables related to inputs, transformation process, and outputs in the systems approach.

RESULTS: Respondents (n = 341) represented 51 DPDs in 31 states in the United States. Overall, DPD students (88.5%) were mostly or very satisfied with their choice of majoring in dietetics. Most (84.0%) planned to earn the RDN credential. Nearly half (46.9%) of DPD students were somewhat or extremely concerned about their readiness to continue their dietetics education path due to the pandemic-related learning conditions. Most students (43.6%) reported dissatisfaction with asynchronous remote instruction in laboratory courses. DPD students’ GPAs remained consistent within the range of 3.75-4.0 from Fall 2019 (43.2%) to Spring 2022 (44.5%). The most important expectations of professors moving forward were to communicate effectively (97.3%), employ cultural humility (93.8%), eliminate discrimination in the classroom (93.6%), provide lecture slides (89.7%), and be flexible and accommodating (88.7%).

CONCLUSIONS: DPD students emerged from COVID-19 with new perspectives and expectations for their university learning experience. Future research should explore the perspectives of DI directors, preceptors, and employers of COVID-19 era DPD graduates.

PMID:38448906 | DOI:10.1186/s12909-024-05251-2

Trials. 2024 Mar 7;25(1):171. doi: 10.1186/s13063-024-08025-9.

ABSTRACT

BACKGROUND: With an increasing collection of patient-reported outcomes (PROs) to measure health-related quality of life (HRQoL) in oncological patients, there is still a lack of standardised strategies on how to interpret and use these data in patient care. Prior research has shown support for the use of digital PRO monitoring together with alarm systems to notify clinicians when the PRO values are deteriorating. This system has demonstrated advantages in improving HRQoL and increasing survival rates among oncology patients. Hence, we designed the PRO B study, a superiority multi-centre randomised controlled trial, to investigate the effects of alarm-based monitoring in metastatic breast cancer patients in Germany. The study protocol for the PRO B study was published in September 2021, and this manuscript describes a formal statistical analysis plan (SAP) for the PRO B study to improve the transparency and quality of this trial.

METHODS AND DESIGN: The trial aimed to recruit 1000 patients with metastatic breast cancer. However, as of the completion of recruitment on June 15, 2023, we have successfully enrolled 924 patients from 52 breast cancer centres. Patients were 1:1 stratified randomised to the intervention and control groups. App-based PRO questionnaires are sent weekly to the intervention group and every 3 months to the control group. Only patients in the intervention group trigger an alarm if their PRO scores deteriorate, and they are subsequently contacted by the local care team within 48 h. The primary outcome is the fatigue score at 6 months, and secondary outcomes are other HRQoL and overall survival. Evaluation of the superiority of the intervention will be done using a linear mixed model with random intercepts for study centres.

CONCLUSION: This detailed SAP defines the main components of the statistical analysis for the PRO B study to assist the statistician and prevent bias in selecting analysis and reporting findings. Version 1 of the SAP was finalised on January 18, 2024.

TRIAL REGISTRATION: DRKS (German Clinical Trials Register) DRKS00024015 . Registered on February 15, 2021.

PMID:38448904 | DOI:10.1186/s13063-024-08025-9

Appl Neuropsychol Adult. 2024 Mar 6:1-11. doi: 10.1080/23279095.2024.2324126. Online ahead of print.

ABSTRACT

Succession law, which governs the creation and validity of wills, is closely tied to testamentary capacity (TC), the cognitive competence required for a valid will. This study explores TC in acute stroke patients and its connections to demographic and clinical characteristics. The research included first-time stroke patients admitted within 24 hours of symptom onset, meeting specific criteria. Data were collected, and assessment tools like the Addenbrooke’s Cognitive Examination III (ACE-III) and Testamentary Capacity Assessment Tool (TCAT) were used. The study found that TCAT scores were not significantly affected by age or gender but positively correlated with education, the Barthel Index and ACE-III scores. They were negatively associated with National Institutes of Health Stroke Scale (NIHSS) and Modified Rankin Scale (mRS) scores. Specific cognitive domains, particularly memory and attention, were independent determinants of TCAT scores. This research introduces TCAT as a valuable tool for evaluating testamentary capacity in stroke patients and highlights the multifaceted nature of TC, emphasizing the need for a nuanced approach. As the population ages and complex medical conditions become more prevalent, understanding the interplay between cognitive functioning and testamentary capacity becomes increasingly crucial for both legal and medical professionals.

PMID:38447221 | DOI:10.1080/23279095.2024.2324126

Int Wound J. 2024 Mar;21(3):e14764. doi: 10.1111/iwj.14764.

ABSTRACT

Foot infections, sores or deep tissue damage from diabetes can be a serious psychological and physical injury. This paper aims at making meta-analyses on the therapeutic effects of traditional Chinese medicine (TCM) on diabetic foot ulcers. The Chinese National Knowledge Infrastructure, VIP Database, Wanfang Database and so on, has conducted a randomized controlled trial to evaluate the clinical effect of TCM soaking method for diabetes patients with diabetes. Literature has been determined to be included by computer search and by hand rough checks. The search period was from the creation of the database to October 2023. Review Manager 5.3 was used to analyse the meta data and evaluate it systematically. Altogether, 479 research was conducted in China’s data base and 20 of them were eventually collected for the final statistical analysis. In all, 1361 patients were enrolled in the trials. The results indicated that TCM immersion in diabetic foot resulted in significantly improved obvious wound healing (OR, 3.2; 95% CI, 2.5, 4.09, p < 0.0001); results showed that TCM immersion therapy significantly increased the efficiency of effective wound healing (OR, 4.55; 95% CI, 3.25, 6.37, p < 0.001). Statistical significance was found. Using Egger’s approach to detect publishing bias suggests that there is no risk of publishing bias in terms of marked wound healing and effective healing. Traditional Chinese drug immersion can increase obviously the recovery ratio and the effective recovery ratio of diabetic foot.

PMID:38447218 | DOI:10.1111/iwj.14764

Interdiscip Cardiovasc Thorac Surg. 2024 Mar 6:ivae034. doi: 10.1093/icvts/ivae034. Online ahead of print.

ABSTRACT

OBJECTIVES: To investigate if there is still a place for bioprosthetic mitral valve replacement in children by comparing the prosthetic durability and transplant-free survival after bioprosthetic and mechanical mitral valve replacement.

METHODS: We reviewed all mitral valve replacements in children between 1981 and 2020. Bioprosthetic mitral valve replacement cases were individually matched to mechanical mitral valve replacement cases. The incidence rate of a second replacement was calculated using the cumulative incidence function that considered death or transplantation as a competing risk.

RESULTS: The median age at implantation was 3.6 years (IQR, 0.8; 7.9) for the bioprosthetic valve cohort (n = 28) and 3 years (IQR, 1.3; 7.8) for the mechanical valve cohort (n = 28). Seven years after bioprosthetic mitral valve replacement, the cumulative incidence of death or transplantation was 17.9% (95% CI, 6.3-34.1) and the cumulative incidence of a second replacement was 63.6% (95% CI, 39.9-80.1). Seven years after mechanical mitral valve replacement, the cumulative incidence of death or transplantation was 28.6% (95% CI, 13.3-46) and the cumulative incidence of a second replacement was 10.7% (95% CI, 2.6-25.5). 15 years after mechanical mitral valve replacement, the cumulative incidence of death or transplantation was 33.6% (95% CI, 16.2-52.1) and the cumulative incidence of a second replacement was 41.1% (95% CI, 18.4-62.7). The cumulative incidence curves for bioprosthetic and mechanical mitral valve replacement were statistically different for a second valve replacement (P < 0.001) but not for death or transplantation (P = 0.33).

CONCLUSIONS: There is no difference in transplant-free survival after bioprosthetic and mechanical mitral valve replacement in children. The lifespan of bioprosthetic mitral valves remains limited in children because of structural valve failure due to calcification. After 15 years, 40% of mechanical valves were replaced, primarily because of patient-prosthesis mismatch related to somatic growth.

PMID:38447197 | DOI:10.1093/icvts/ivae034