Category: Statistics

Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2023 Dec;35(12):1233-1240. doi: 10.3760/cma.j.cn121430-20230717-00528.

ABSTRACT

Phosgene is not only a dangerous asphyxiating chemical warfare agent, but also an important chemical raw material, which is widely used in chemical production. According to statistics, there are more than 1 000 phosgene production enterprises in China, with an annual production volume of more than 3 million tons and hundreds of thousands of employees. Therefore, once the leakage accident occurs during production, storage and transportation, it often causes a large number of casualties. In the past 20 years, phosgene poisoning accidents in China have occurred from time to time, and due to the weak irritation, high density, and high concentration of phosgene at the scene of the accident, it often results in acute high-concentration inhalation of the exposed, triggering acute lung injury (ALI), and is very likely to progress to acute respiratory distress syndrome (ARDS), with a mortality rate up to 40%-50%. In view of the characteristics of sudden, mass, concealed, rapid and highly fatal phosgene, and the mechanism of its toxicity and pathogenicity is still not clear, there is no effective treatment and standardized guidance for the sudden group phosgene poisoning. In order to improve the efficiency of clinical treatment and reduce the mortality, this paper has summarized the pathophysiological mechanism of phosgene poisoning, clinical manifestations, on-site treatment, research progress, and innovative clinical therapies by combining the extensive basic research on phosgene over the years with the abundant experience in the on-site treatment of sudden mass phosgene poisoning. This consensus aims to provide guidance for the clinical rescue and treatment of patients with sudden mass phosgene poisoning, and to improve the level of treatment.

PMID:38149382 | DOI:10.3760/cma.j.cn121430-20230717-00528

Pediatr Transplant. 2023 Dec 27:e14664. doi: 10.1111/petr.14664. Online ahead of print.

ABSTRACT

INTRODUCTION: Pediatric heart transplant patients are routinely followed in dermatology clinics due to elevated risk of cutaneous malignancy. However, transplant patients may experience other, non-cancer-related dermatologic conditions including skin infections, inflammatory diseases, and drug eruptions that can cause significant medical and psychosocial comorbidity.

METHODS: A retrospective chart review of all pediatric heart transplant patients at Mayo Clinic Children’s Center in Rochester, MN, was performed to determine the prevalence and spectrum of non-cancer dermatologic conditions. Statistical analysis was conducted to look for associations between episodes of rejection and skin condition development.

RESULTS: Of the 65 patients who received heart transplants under the age of 18 and were followed at Mayo Clinic, 69% (N = 45) were diagnosed with at least one skin condition between transplant and the time of most recent follow-up. Sixty-two percent (N = 40) of patients were diagnosed with an inflammatory skin condition (most commonly acne and atopic dermatitis), 45% (N = 29) with an infectious skin condition (most commonly warts and dermatophyte infection), and 32% (N = 21) with a drug eruption (most commonly unspecified rash and urticaria). No association was found between presence of skin disease and number of rejection episodes.

CONCLUSIONS: Non-cancer dermatologic conditions are prevalent within pediatric heart transplant recipients and may directly impact their medical needs and quality of life. Dermatologist involvement in the care of post-transplant pediatric patients is important, not only for cancer screening but also for diagnosis and treatment of common infectious and inflammatory skin conditions.

PMID:38149373 | DOI:10.1111/petr.14664

Intern Med J. 2023 Dec 27. doi: 10.1111/imj.16306. Online ahead of print.

ABSTRACT

BACKGROUND: Eosinophilic oesophagitis (EOE) is a known cause of food bolus obstruction (FBO) with rising incidence and prevalence.

AIMS: To assess the rates of EOE in adult cases presenting with an FBO via prospective biopsy collection during index endoscopy.

METHODS: Oesophageal FBO cases requiring gastroscopy between February 2014 and January 2021 at a single institution with a unified policy to perform biopsies on FBO cases were analysed using medical records, endoscopy and histology. Statistical analysis was undertaken to compare those with and without EOE as their final diagnosis, including the timing of oesophageal biopsy and the season that cases presented.

RESULTS: One hundred ninety FBO presentations were analysed, 15 patients presented twice and one patient presented four times within the 7-year study period. Men represented 72% of cases. A total of 78% of cases had biopsies collected at an index or scheduled follow-up endoscopy. EOE was the cause of the FBO in 28% (53/190) of presentations. FBO secondary to EOE was more likely to occur in the spring and summer months (Australian September to March), with 39% (19 of 49) of cases presenting in spring attributable to EOE.

CONCLUSION: EOE affects a significant proportion of patients presenting with FBO (28%); a high biopsy rate of 78% in FBO cases provides an opportunity for prompt diagnosis and treatment.

PMID:38149363 | DOI:10.1111/imj.16306

Turk J Anaesthesiol Reanim. 2023 Dec 27;51(6):477-484. doi: 10.4274/TJAR.2023.231328.

ABSTRACT

OBJECTIVE: Numerous studies performed worldwide indicate that the public has limited knowledge of anaesthesia practices and anaesthetists’ duties and responsibilities. This study aimed to identify the level of knowledge about anaesthetists and anaesthesia practices, and to assess the reasons for anxiety about anaesthesia of the population admitted to our hospital, which is tertiary in Turkey. The secondary aim was to analyze their differences according to sex, education level, and acquired anaesthesia experience.

METHODS: A survey comprising 23 questions was administered to 400 patients and/or their relatives, aged 18-85 years, who presented to our clinic for preoperative anaesthesia evaluation and for whom elective surgery was planned from March through October 2017.

RESULTS: Of the 400 participants, 213 were women and 187 were men. Of all participants in the survey, 51.2% were patients and 48.8% were patient relatives; 64.2% had anaesthesia experience and 35.8% had never had anaesthesia before. The survey group’s level of knowledge about anaesthesia was generally low. According to education level, there was a statistically significant difference in the anaesthesia recognition level. However, the acquired anaesthesia experience did not affect the anaesthesia recognition level.

CONCLUSION: To raise the level of knowledge about this topic, anaesthetists must provide patients with more detailed information during preoperative and postoperative visits, which would significantly reduce their anxiety levels. Further, we determined that increasing the use of methods such as media-based brochures, booklets, and videos to inform patients may increase knowledge levels and reduce anxiety levels.

PMID:38149358 | DOI:10.4274/TJAR.2023.231328

Microsurgery. 2023 Dec 27. doi: 10.1002/micr.31139. Online ahead of print.

ABSTRACT

BACKGROUND: Chronic osteomyelitis is an invalidating disease, and its severity grows according to the infection’s particular features. The Cierny-Maiden criteria classify it according to the anatomical aspects (I to IV) and also by physiological class (A host being in good immune condition and B hosts being locally (L) or systemically (S) compromised). The surgical approach to chronic osteomyelitis involves radical debridement and dead space reconstruction. Two-stage management with delayed reconstruction is the most common surgical management, while one-stage treatment with concomitant reconstruction is a more aggressive approach with less available literature. Which method gives the best results is unclear. The purpose of this study is to compare single and two-stage techniques.

METHODS: The authors carried out a retrospective multicentric cohort study to compare two primary outcomes (bone union and infection healing) in one versus two-stage reconstructions with vascularized bone flaps in 23 cases of limb osteomyelitis (22 patients, 23 extremities). Thirteen subjects (56.5%) sustained a single-stage treatment consisting of a single surgery of radical debridement, concomitant soft tissue coverage, and bone reconstruction. Ten cases (43.5%) sustained a two-stage approach: radical debridement, simultaneous primary soft tissue closure, and antibiotic PMMA spacers implanted in 7 patients.

RESULTS: No statistical differences were observed between one- and two-stage approaches in bone union rate and infection recurrence risk. Even though bone union seems to be higher and faster in the two-stage than in the one-stage group, and all infection relapses occurred in the one-stage group, data did not statistically confirm these differences. Two of the six cases (33.3%) of bone nonunion occurred in compromised hosts (representing only 17.4% of our sample). The B-hosts bone union rate was 50.0%, while it reached 78.9% in A-hosts, but the difference was not statistically significant (p = .5392). Infection recurrence was higher in B-hosts than in A-hosts (p = .0086) and in Pseudomonas aeruginosa sustained infections (p = .0208), but in the latter case, the treatment strategy did not influence the outcome (p = .4000).

CONCLUSIONS: Bone union and infection healing rates are comparable between one and two-stage approaches. Pseudomonas aeruginosa infections have a higher risk of infection relapse, with similar effectiveness of one- and two-stage strategies. B-hosts have a higher infection recurrence rate without comparable data between the two approaches. Further studies with a larger sample size are required to confirm our results and define B-hosts’ best strategy.

LEVEL OF EVIDENCE: Level III of evidence, retrospective cohort study investigating the results of treatments.

PMID:38149353 | DOI:10.1002/micr.31139

Stat Med. 2023 Dec 27. doi: 10.1002/sim.9982. Online ahead of print.

ABSTRACT

Nearly 300,000 older adults experience a hip fracture every year, the majority of which occur following a fall. Unfortunately, recovery after fall-related trauma such as hip fracture is poor, where older adults diagnosed with Alzheimer’s disease and related dementia (ADRD) spend a particularly long time in hospitals or rehabilitation facilities during the post-operative recuperation period. Because older adults value functional recovery and spending time at home versus facilities as key outcomes after hospitalization, identifying factors that influence days spent at home after hospitalization is imperative. While several individual-level factors have been identified, the characteristics of the treating hospital have recently been identified as contributors. However, few methodological rigorous approaches are available to help overcome potential sources of bias such as hospital-level unmeasured confounders, informative hospital size, and loss to follow-up due to death. This article develops a useful tool equipped with unsupervised learning to simultaneously handle statistical complexities that are often encountered in health services research, especially when using large administrative claims databases. The proposed estimator has a closed form, thus only requiring light computation load in a large-scale study. We further develop its asymptotic properties with stabilized inference assisted by unsupervised clustering. Extensive simulation studies demonstrate superiority of the proposed estimator compared to existing estimators.

PMID:38149345 | DOI:10.1002/sim.9982

Cardiol Young. 2023 Dec 27:1-7. doi: 10.1017/S1047951123004195. Online ahead of print.

ABSTRACT

OBJECTIVE: The present study aimed to investigate the relationship between unexplained chest pain in children with parents’ mental problems, parental attitudes, family functionality, and the child’s mental problems.

MATERIAL AND METHOD: A total of 433 children (between 11 and 18 years of age) applied to the Pediatric Cardiology Outpatient Clinic due to chest pain in the last year. A clinical interview was conducted by a child psychiatrist with 43 patients and 33 controls included in the study due to unexplained chest pain.

RESULTS: Family history of physical illness was significantly higher in the chest pain group. When evaluated in terms of psychosocial risk factors, life events causing difficulties, derangement in the family, loss of a close person, and exposure to violence were statistically significantly higher in the group with chest pain. Mental disorders were observed in 67.4% of the children in the chest pain group as a result of the clinical interview. The total score of the DSM-5 somatic symptoms scale, which evaluates other somatic complaints in the chest pain group, was also significantly higher. When the family functions of both groups were evaluated, communication, emotional response, behaviour control, and general functions sub-dimensions were statistically significantly higher in families in the chest pain group.

CONCLUSION: We recommend that psychiatric evaluation be included in diagnostic research to prevent unnecessary medical diagnostic procedures in children describing unexplained chest pain, as well as to prevent the potential for diagnosing mental disorders in both children and adults.

PMID:38149344 | DOI:10.1017/S1047951123004195

Health Econ. 2023 Dec 26. doi: 10.1002/hec.4791. Online ahead of print.

ABSTRACT

The cost effectiveness of medical treatments is not precisely known due to the compounding effect of multiple determining factors. Ambulance response time (RT) to emergency calls is exploited to learn more about the effect of the timing of treatment on health outcomes. This causal relation is identified by exploiting rainfall at the time of the ambulance run as a shock to RT. The analysis focuses on patients who have undergone a cardiac event and shows that a one-minute increase in average RT leads to 105 more deaths each year in one Italian region. Finally, the economic value of the lives that would be saved by reducing RT is quantified to facilitate policymaking.

PMID:38148482 | DOI:10.1002/hec.4791

Ther Innov Regul Sci. 2023 Dec 26. doi: 10.1007/s43441-023-00598-y. Online ahead of print.

ABSTRACT

BACKGROUND: In 2016, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use updated its efficacy guideline for good clinical practice and introduced predefined quality tolerance limits (QTLs) as a quality control in clinical trials. QTLs are complementary to Quality by Design (QbD) principles (ICH-E8) and are one of the components of the risk-based clinical trial quality management system.

METHODS: Currently the framework for QTLs process is well established, extensively describing the operational aspects of Defining, Monitoring and Reporting, but a single source of commonly used methods to establish QTLs and secondary limits is lacking. This paper will primarily focus on closing this gap and include applications of statistical process control and Bayesian methods on commonly used study level quality parameters such as premature treatment discontinuation, study discontinuation and significant protocol deviations as examples.

CONCLUSIONS: Application of quality tolerance limits to parameters that correspond to critical to quality factors help identify systematic errors. Some situations pose special challenges to implementing QTLs and not all methods are optimal in every scenario. Early warning signals, in addition to QTL, are necessary to trigger actions to further minimize the possibility of an end-of-study excursion.

PMID:38148473 | DOI:10.1007/s43441-023-00598-y

Odontology. 2023 Dec 26. doi: 10.1007/s10266-023-00875-0. Online ahead of print.

ABSTRACT

AIM: To evaluate the bleaching efficacy and effects on enamel properties of experimental gels with carbamide peroxide (CP; 10%) or hydrogen peroxide (HP; 6%) containing calcium polyphosphate sub-microparticles (CaPPs).

METHODS: A total of 216 bovine tooth specimens were divided for microhardness and color analyses (n = 108) and block randomized into nine groups (n = 12): (G1) commercial CP (Whiteness Perfect, FGM; Brazil); (G2) experimental CP; (G3) CP-0.5%CaPPs; (G4) CP-1.5%CaPPs; (G5) commercial HP (Potenza Bianco, PHS; Brazil); (G6) experimental HP; (G7) HP-0.5%CaPPs; (G8) HP-1.5%CaPPs; (G9) artificial saliva. The gels’ pH values were determined with a bench pH meter. Color (ΔE, ΔE₀₀, ΔWI_D) and microhardness variation were evaluated before and after the therapy. Part of the specimens used for microhardness was submitted to the scanning electron microscopy (SEM) (n = 3) and energy-dispersive X-ray spectroscopy EDX (n = 3) analyses. Statistical analyses were performed in the R statistical software (α = 0.05). Linear mixed models for repeated measures in time were used to analyze microhardness and L* values. Generalized linear models were used to analyze the a*, b*, ΔE, ΔE₀₀, and ΔWI_D, considering a group effect. The EDX data were analyzed using a one-way ANOVA with Tukey’s test.

RESULTS: The gels’ pH remained over 6,0. All gels effectively bleached the specimens and did not differ significantly. When compared to the control group, the hardness was significantly lower in the G1, G2, G6, and G7 groups. The G3, G4, G5, and G8 groups did not differ significantly (p > 0.05).

CONCLUSION: The incorporation of CaPPs in low-concentration whitening gels reduces its negative effects on microhardness without interfering with their bleaching efficacy.

PMID:38148447 | DOI:10.1007/s10266-023-00875-0