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The aim was to develop and psychometrically test the burn inpatient nursing dependency assessment scale (BINDAS).This was a scale development study.This study was conducted in four phases from November 2019 to November 2021. Items were generated and the initial scale was constructed in phase 1. The preliminary evaluation of items was conducted through expert reviews and a pilot study in phase 2. The scale, including item quality, reliability and validity, was validated with 420 individuals in phase 3. The translation of the scale from Chinese to English was performed in phase 4.Content validity was satisfactory. Thirteen items were retained after item analysis, and three factors accounting for 73% of the total item variance were extracted through exploratory and confirmatory factor analyses. Predictive validity with nursing time spent with patients during 24 h was also estimated, with r = .66 (p .01). Receiver operating characteristic analysis was conducted, and an area under the curve of the scale of 0.94 was obtained. Concurrent validity with Barthel index was estimated, with r = -.71 (p .01). Cronbach's alpha coefficient for scale was .93, and the correlation between raters for total scores was .95.Burn inpatient nursing dependency assessment scale is a psychometrically valid and reliable measurement instrument as well as objective other-rating scale with 12 items for scoring on a four-point scale (0, 1, 2 or 3) and 1 item for scoring on a two-point scale (0 or 2). BINDAS with 13 items was developed in this study. Nurses can give each patient a total score of 0-38. A high score indicates high nursing dependency. The 13-item scale consists of three factors: basic care need, physiological index, and psychology and adaptation.This scale demonstrated satisfactory psychometric properties and can be used to evaluate patient dependency on nurses in burn units and optimize an individual's care plan to achieve efficient staff allocation.

Background Oral health is a key indicator of overall health, well-being and quality of life. The oral health status of the elderly will decline with age, which results in serious consequences and bring heavy medical and economic burdens to the country and society. With the aggravation of population aging process, more and more attention has been paid to the oral health problems of the elderly in mainland China, the number of studies focusing on oral care for the elderly is increasing year by year, and many research papers have been published in journals. However, no scholar has conducted bibliometric analysis in this field so far. The purpose of this study is to analyze the status, hotspots and trends of research on oral care for the elderly in mainland China in the past 20 years through bibliometrics, which aims to provide new ideas and targets for future clinical work and research. Methods Relevant literature from January 2002 to May 2022 were retrieved from China National Knowledge Infrastructure, Wanfang, China Science and Technology Journal Database, Web of Science, and PubMed. NoteExpress 3.5.0.9054, Co-Occurrence 12.6 and CiteSpace 6.1.R2 were used to analyze bibliometric features in terms of year of publication, journal of publication, authors, institution and keywords. Results A total of 716 related articles were obtained. Data analysis revealed that the number of publications shows an increasing trend over time, only 2017–2021, 309 papers were published, accounting for 43.2% of the total number of publications. A total of 238 articles were published in Science Citation Index journals or Chinese core journals, accounting for 33.2% of the total number of articles, and only a few core journals among the top 10 journals. The study of oral health-related quality of life in the elderly is a hot research topic. There is a lack of research on the elderly living in elderly care facilities. Conclusion The present study provides an in-depth understanding of oral care in the elderly in mainland China. The study showed the current research status, hotspots and trends of this field, and future research direction is prospected.

Background The COVID-19 pandemic has forced nucleic acid detection to be essential for prevention and control. The psychological and physical health of healthcare staff who conducted nucleic acid sampling should be paid attention to. This study aims to investigate the status and explore the predictors of stress among nucleic acid sampling support nurses (NASSNs) by an online survey. Material and Methods Totally 388 NASSNs were recruited for the research. An online cross-sectional survey with structured questionnaires was used, including socio-demographic information, the stressor scale of nucleic acid sampling nurses (SSNASN), and the challenge-hindrance stress scale (CHSS). T-tests, ANOVA, and multivariable linear regression model were used to analyze data. Results A total of 324 NASSNs filled out questionnaires online with a response rate of 83.51%. NASSNs had an overall mean score of (2.199 ± 0.917) for challenge stress and (2.014 ± 0.805) for hindrance stress. The item "the amount of responsibility I have" scored highest in the challenge stress dimension, while "the lack of job security I have" scored highest in the hindrance stress dimension. The predictors of challenge and hindrance stress include concern about the preparedness of NASSNs and their families, working environment, and competence of emergency disposal. An additional socio-demographic predictor of challenge stress was motivation, while that of hindrance stress was longer nursing experiences. Conclusions During the COVID-19 pandemic, stress among NASSNs was moderately low. The factors detected to be predictors of stress include motivation, nursing experiences, concern about the preparedness of NASSNs and their families, working environment, and competence in emergency disposal.

In Phase III clinical trials for life-threatening conditions, some serious but expected adverse events, such as early deaths or congestive heart failure, are often treated as the secondary or co-primary endpoint, and are closely monitored by the data and safety monitoring committee. A naïve group sequential design for such a study is to specify univariate statistical boundaries for the efficacy and safety endpoints separately, and then implement the two boundaries during the study, even though the two endpoints are typically correlated. One problem with this naïve design, which has been noted in the statistical literature, is the potential loss of power. In this paper, we develop an analytical tool to evaluate this negative impact for trials with non-trivial safety event rates, particularly when the safety monitoring is informal. Using a bivariate binary power function for the group sequential design with a random effect component to account for subjective decision making in safety monitoring, we demonstrate how, under common conditions, the power loss in the naïve design can be substantial. This tool may be helpful to entities such as the data and safety monitoring committees when they wish to deviate from the pre-specified stopping boundaries based on safety measures.

Background Anti-CD19 CAR T cell therapy has demonstrated high response rates in patients with relapsed or refractory (r/r) B cell malignancies but is associated with significant toxicity. Cytokine release syndrome (CRS) is the most significant complication associated with CAR T cell therapy, and it is critical to have a reproducible and easy method to grade CRS after CAR T cell infusions. Discussion The Common Terminology Criteria for Adverse Events scale is inadequate for grading CRS associated with cellular therapy. Clinical experience with the anti-CD19 CAR T cell therapy tisagenlecleucel at the University of Pennsylvania (Penn) was used to develop the Penn grading scale for CRS. The Penn grading scale depends on easily accessible clinical features; does not rely on location of care or quantitation of supportive care; assigns grades to guide CRS management; distinguishes between mild, moderate, severe, and life-threatening CRS; and applies to both early-onset and delayed-onset CRS associated with T cell therapies. Clinical data from 55 pediatric patients with r/r B cell acute lymphoblastic leukemia and 42 patients with r/r chronic lymphocytic lymphoma treated with tisagenlecleucel were used to demonstrate the current application of the Penn grading scale. Conclusion We show that the Penn grading scale provides reproducible CRS grading that can be useful to guide therapy and that can be applied across clinical trials and treatment platforms.

In phase III clinical trials, some adverse events may not be rare or unexpected and can be considered as a primary measure for safety, particularly in trials of life-threatening conditions, such as stroke or traumatic brain injury. In some clinical areas, efficacy endpoints may be highly correlated with safety endpoints, yet the interim efficacy analyses under group sequential designs usually do not consider safety measures formally in the analyses. Furthermore, safety is often statistically monitored more frequently than efficacy measures. Because early termination of a trial in this situation can be triggered by either efficacy or safety, the impact of safety monitoring on the error probabilities of efficacy analyses may be nontrivial if the original design does not take the multiplicity effect into account. We estimate the actual error probabilities for a bivariate binary efficacy–safety response in large confirmatory group sequential trials. The estimated probabilities are verified by Monte Carlo simulation. Our findings suggest that type I error for efficacy analyses decreases as efficacy–safety correlation or between-group difference in the safety event rate increases. In addition, although power for efficacy is robust to misspecification of the efficacy–safety correlation, it decreases dramatically as between-group difference in the safety event rate increases. Copyright © 2012 John Wiley & Sons, Ltd.

Permuted block design is the most popular randomization method used in clinical trials, especially for trials with more than two treatments and unbalanced allocation, because of its consistent imbalance control and simplicity in implementation. However, the risk of selection biases caused by high proportion of deterministic assignments is a cause of concern. Efron's biased coin design and Wei's urn design provide better allocation randomness without deterministic assignments, but they do not consistently control treatment imbalances. Alternative randomization designs with improved performances have been proposed over the past few decades, including Soares and Wu's big stick design, which has high allocation randomness, but is limited to two-treatment balanced allocation scenarios only, and Berger's maximal procedure design which has a high allocation randomness and a potential for more general trial scenarios, but lacks the explicit function for the conditional allocation probability and is more complex to implement than most other designs. The block urn design proposed in this paper combines the advantages of existing randomization designs while overcoming their limitations. Statistical properties of the new algorithm are assessed and compared to currently available designs via analytical and computer simulation approaches. The results suggest that the block urn design simultaneously provides consistent imbalance control and high allocation randomness. It can be easily implemented for sequential clinical trials with two or more treatments and balanced or unbalanced allocation.

Weng Y, Korte JE. Racial disparities in being recommended to surgery for oral and oropharyngeal cancer in the United States. Community Dent Oral Epidemiol 2012; 40: 80–88. © 2011 John Wiley & Sons A/S Abstract – Objectives: To investigate the impact of race on the likelihood of patients being recommended for surgery after a diagnosis of oral and oropharyngeal cancer. Methods: A total of 68 445 cases of oral and oropharyngeal cancer were extracted from the 1988 to 2005 Surveillance, Epidemiology, and End Results (SEER) database. County-level rurality data and income data were merged using the US Department of Agriculture Rural-Urban Continuum Codes dataset and US Census Bureau Small Area Income & Poverty Estimates dataset. We used logistic regression analyses to investigate the impact of race on being recommended to surgery for oral and oropharyngeal cancer, adjusting for demographic, socioeconomic, and clinical factors. Stratified analyses were further conducted by tumor site and rural/urban status. Results: Recommendation to surgery varied significantly by race, with black patients less likely than white patients to be recommended to surgery for their oral and oropharyngeal cancer. The racial difference in recommendation to surgery varied significantly by age, geography, and tumor subsite. Racial disparities are most evident in lip and buccal cancer from rural areas (OR, 4.4; 95% CI, 2.6–7.5); and least evident in oropharyngeal cancer from urban areas (OR, 1.2; 95% CI, 1.1–1.3). The magnitude of the racial disparity is attenuated with increasing age. Conclusions: We observed substantial racial disparities in surgery recommendation for oral and oropharyngeal cancer in the United States. Our results suggest the need to improve accessibility to better health care in racial minority groups, particularly in rural areas, and call for individual and institutional efforts to avoid physician bias related to the patient’s sociodemographic characteristics in healthcare service.

To evaluate the performance of randomization designs under various parameter settings and trial sample sizes, and identify optimal designs with respect to both treatment imbalance and allocation randomness, we evaluate 260 design scenarios from 14 randomization designs under 15 sample sizes range from 10 to 300, using three measures for imbalance and three measures for randomness. The maximum absolute imbalance and the correct guess (CG) probability are selected to assess the trade-off performance of each randomization design. As measured by the maximum absolute imbalance and the CG probability, we found that performances of the 14 randomization designs are located in a closed region with the upper boundary (worst case) given by Efron's biased coin design (BCD) and the lower boundary (best case) from the Soares and Wu's big stick design (BSD). Designs close to the lower boundary provide a smaller imbalance and a higher randomness than designs close to the upper boundary. Our research suggested that optimization of randomization design is possible based on quantified evaluation of imbalance and randomness. Based on the maximum imbalance and CG probability, the BSD, Chen's biased coin design with imbalance tolerance method, and Chen's Ehrenfest urn design perform better than popularly used permuted block design, EBCD, and Wei's urn design.

To investigate the situation of quality control in geriatric care institutions (GCI) and identify the existing problems and propose management strategies, a questionnaire survey and field survey was conducted in 270 GCIs in Shanghai in 2014, including facilities, human resources, characteristics of elder patients, distribution of adverse events and quality of geriatric care. Descriptive methods were used for data analysis. Totally 25 geriatric care hospitals (GCH) and 245 community health service centers (CHSC) responded to the survey. There were 6140 beds for elderly care in GCHs where mean length stay of elder patients were 140 days, while 10265 beds in CHSCs where mean length stay of elder patients were 119 days. The proportions of nursing assistants, nurses, medical physicians and technicians in GCHs were 37.91%, 29.11%, 19.62% and 13.35%, while those in CHSCs were 14.14%, 34.59%, 36.47% and 14.80%. The top five most frequent adverse events in GCHs were fall, medication, catheter, diet and transfusion related events, while those in CHSCs were medication, fall, catheter, transfusion and hurt related events. During field survey, public GCHs were found better in quality of elderly care than private ones after expert assessments. Our results indicate that administrators in GCIs should improve medical and nursing facilities, increase human resource, optimize geriatric nurse training system, implement risk analysis and quality management to promote quality of care for the elderly.

To identify factors associated with increased gingival inflammation in adults with systemic sclerosis (SSc, scleroderma).In this cross-sectional study, forty-eight adults with SSc received assessment of gingival inflammation using Löe and Silness gingival index (LSGI), measurement of oral aperture and evaluation of manual dexterity to perform oral hygiene using the Toothbrushing Ability Test, as well as completion of an oral health-related questionnaire.Three explanatory variables in the final multiple predictor models for the LSGI outcome were statistically significant--manual dexterity to perform oral hygiene, flossing in the evening and SSc subtype, with higher (i.e., worse) LSGI score among those with impaired manual dexterity, not flossing in the evening and diffuse form of SSc. In addition, posterior teeth had higher LSGI scores compared with that of the anterior teeth after adjusting for other variables.Results suggest that dental health professionals take manual dexterity into consideration when educating patients with SSc to improve their oral hygiene and educate them on paying more attention on cleaning their posterior teeth and the importance of flossing in the evening--especially those who only floss once a day or less often.

To investigate the impact of race on the likelihood of patients being recommended for surgery after a diagnosis of oral and oropharyngeal cancer.A total of 68,445 cases of oral and oropharyngeal cancer were extracted from the 1988 to 2005 Surveillance, Epidemiology, and End Results (SEER) database. County-level rurality data and income data were merged using the US Department of Agriculture Rural-Urban Continuum Codes dataset and US Census Bureau Small Area IncomePoverty Estimates dataset. We used logistic regression analyses to investigate the impact of race on being recommended to surgery for oral and oropharyngeal cancer, adjusting for demographic, socioeconomic, and clinical factors. Stratified analyses were further conducted by tumor site and rural/urban status.Recommendation to surgery varied significantly by race, with black patients less likely than white patients to be recommended to surgery for their oral and oropharyngeal cancer. The racial difference in recommendation to surgery varied significantly by age, geography, and tumor subsite. Racial disparities are most evident in lip and buccal cancer from rural areas (OR, 4.4; 95% CI, 2.6-7.5); and least evident in oropharyngeal cancer from urban areas (OR, 1.2; 95% CI, 1.1-1.3). The magnitude of the racial disparity is attenuated with increasing age.We observed substantial racial disparities in surgery recommendation for oral and oropharyngeal cancer in the United States. Our results suggest the need to improve accessibility to better health care in racial minority groups, particularly in rural areas, and call for individual and institutional efforts to avoid physician bias related to the patient's sociodemographic characteristics in healthcare service.

To evaluate the effect of adaptive oral hygiene devices and orofacial exercise to improve gingival health among adults with systemic sclerosis (SSc).Forty-eight patients with SSc were assigned randomly to the multifaceted oral health intervention or usual dental care control group. Participants in the intervention group received a rechargeable, powered Oral-B® oscillating-rotating-pulsating toothbrush and a Reach® Access™ Flosser that has a toothbrush-like handle. For those with an oral aperture of less than 40 mm, orofacial exercises were taught. Participants in the control group were each given a manual toothbrush and dental floss. Participants in both groups received instructions and demonstration on the use of the devices, and were requested to perform the respective intervention twice a day for 6 months. Evaluations were at baseline, 3-, and 6-months. The main outcome was gingival index (GI), an indicator of gingival inflammation.Both groups showed significant reduction in GI scores at 6 months (ps0.005). Reduction in GI scores of the intervention group at 6 months was 20.8% which is considered to be clinically significant. Compared to the control group, the intervention group showed a significant and larger reduction in GI score by 8% at 6 months (p=0.0007).Results support the use of adaptive devices and orofacial exercise to improve gingival health in adults with SSc when compared to use of manual toothbrushing and finger-held flossing. Recommending and educating patients with SSc to use adaptive devices to clean the tooth surfaces looks promising for long-term oral health improvement.

Open label and single blinded randomized controlled clinical trials are vulnerable to selection bias when the next treatment assignment is predictable based on the randomization algorithm and the preceding assignment history. While treatment predictability is an issue for all constrained randomization algorithms, deterministic assignments are unique to permuted block randomization. Deterministic assignments may lead to treatment predictability with certainty and selection bias, which could inflate the type I error and hurts the validity of trial results. It is important to accurately evaluate the probability of deterministic assignments in permuted block randomization, so proper protection measures can be implemented. For trials with number of treatment arms T =2 and a balance block size B =2 m , Matts and Lachin indicated that the probability of deterministic assignment is 1/( m +1). For more general situations, with T ≥2 and a block size B = ∑ j = 1 T m j , Dupin-Spriet provided a formula, which can be written as ( 1 / B ) ∑ j = 1 T ∑ i = 1 m j ∏ k = 1 i ( m j − k + 1 ) / ( B − k + 1 ) . This formula involves extensive calculation in evaluation. In this paper, we simplified this formula to ( 1 / B ) ∑ j = 1 T m j / ( B − m j + 1 ) for general scenarios and 1/( B − m +1) for trials with a balanced allocation. Through mathematical induction we show the equivalence of the formulas. While the new formula is numerically equivalent to Dupin-Spriet’s formula, the simple format not only is easier for evaluation, but also is clearer in describing the impact of parameters T and m i on the probability of deterministic assignments.