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Bushen Anshen acupuncture for perimenopausal insomnia of kidney-yin deficiency: a randomized controlled trial

Zhongguo Zhen Jiu. 2023 Jun 12;43(6):634-8. doi: 10.13703/j.0255-2930.20220909-k0001.

ABSTRACT

OBJECTIVE: To observe the clinical efficacy of Bushen Anshen acupuncture (acupuncture for tonifying kidney and calming spirit ) in treating perimenopausal insomnia (PMI) of kidney-yin deficiency.

METHODS: A total of 72 patients with PMI of kidney-yin deficiency were randomized into an observation group (36 cases, 1 case dropped off) and a control group (36 cases, 1 case dropped off). Acupuncture was applied at Baihui (GV 20) and bilateral Shenshu (BL 23), Taixi (KI 3), Anmian (Extra) in the observation group, while sham acupuncture of shallow needling at non-acupoints was applied in the control group. The treatment was required once every other day, 3 times a week for 10 times in the two groups. Before and after treatment, Pittsburgh sleep quality index (PSQI) was used to evaluate the subjective sleep quality, and polysomnography (PSG) was used to monitor the objective sleep quality in the two groups.

RESULTS: After treatment, the scores of sleep quality, sleep latency, sleep duration, sleep efficiency, hypnotic, daytime dysfunction and total score of PSQI were decreased compared with those before treatment in the observation group (P<0.01), the scores of sleep duration, sleep efficiency and total score of PSQI were decreased compared with those before treatment in the control group (P<0.05); the scores of sleep quality, sleep latency, sleep efficiency, hypnotic and total score of PSQI in the observation group were lower than those in the control group (P<0.05). After treatment, the sleep time was prolonged, the sleep efficiency was improved, the sleep latency and the awake time after falling asleep were shortened, the arousal awake index was reduced (P<0.01) when PSG indexes were monitored, and the percentage of non-rapid eye movement sleep period 1 (N1%) was decreased while the percentage of non-rapid eye movement sleep period 3 (N3%) was increased (P<0.05) compared with those before treatment in the observation group; there was no statistical difference in the PSG indexes compared with those before treatment in the control group (P>0.05). After treatment, compared with the control group, the sleep time was prolonged, the sleep efficiency was improved, the sleep latency and the awake time after falling asleep were shortened, the arousal awake index and N1% were decreased in the observation group (P<0.01).

CONCLUSION: Bushen Anshen acupuncture can effectively improve the subjective and objective sleep quality in PMI patients of kidney-yin deficiency.

PMID:37313556 | DOI:10.13703/j.0255-2930.20220909-k0001

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Nonsense variant in a consanguineous family expands the phenotype of KPTN gene-related syndrome to include hearing impairment

Clin Genet. 2023 Jun 13. doi: 10.1111/cge.14390. Online ahead of print.

ABSTRACT

A short report with two affected siblings from consanguineous family born with intellectual disability, motor disability, language deficit, and hearing impairment and found to carry biallelic nonsense variant in KPTN gene known to be associated with KPTN gene related syndrome.

PMID:37311648 | DOI:10.1111/cge.14390

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Frequency and Referral Patterns of Neural Antibody Studies During the COVID-19 Pandemic: Experience From an Autoimmune Neurology Center

Neurol Neuroimmunol Neuroinflamm. 2023 Jun 13;10(4):e200129. doi: 10.1212/NXI.0000000000200129. Print 2023 Jul.

ABSTRACT

OBJECTIVE: To determine whether the frequency of paraneoplastic or autoimmune encephalitis antibodies examined in a referral center changed during the COVID-19 pandemic.

METHODS: The number of patients who tested positive for neuronal or glial (neural) antibodies during pre-COVID-19 (2017-2019) and COVID-19 (2020-2021) periods was compared. The techniques used for antibody testing did not change during these periods and included a comprehensive evaluation of cell-surface and intracellular neural antibodies. The chi-square test, Spearman correlation, and Python programming language v3 were used for statistical analysis.

RESULTS: Serum or CSF from 15,390 patients with suspected autoimmune or paraneoplastic encephalitis was examined. The overall positivity rate for antibodies against neural-surface antigens was similar in the prepandemic and pandemic periods (neuronal 3.2% vs 3.5%; glial 6.1 vs 5.2) with a mild single-disease increase in the pandemic period (anti-NMDAR encephalitis). By contrast, the positivity rate for antibodies against intracellular antigens was significantly increased during the pandemic period (2.8% vs 3.9%, p = 0.01), particularly Hu and GFAP.

DISCUSSION: Our findings do not support that the COVID-19 pandemic led to a substantial increase of known or novel encephalitis mediated by antibodies against neural-surface antigens. The increase in Hu and GFAP antibodies likely reflects the progressive increased recognition of the corresponding disorders.

PMID:37311644 | DOI:10.1212/NXI.0000000000200129

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Combination immunochemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: a systematic review and meta-analysis

BMJ Open. 2023 Jun 13;13(6):e069047. doi: 10.1136/bmjopen-2022-069047.

ABSTRACT

OBJECTIVE: To evaluate the efficacy and safety of combination immunochemotherapy regimens for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).

DESIGN: Meta-analysis and systematic review.

DATA SOURCES: PubMed, Embase, Web of Science and Cochrane library and the Clinicaltrials.gov clinical trials registry were searched up to 14 March 2022.

ELIGIBILITY CRITERIA FOR SELECTING STUDIES: We included randomised controlled trials that compared combination immunochemotherapy with conventional chemotherapy for R/M HNSCC. Primary outcomes of interest were overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and adverse effects (AEs).

DATA EXTRACTION AND SYNTHESIS: Two reviewers independently extracted data and assessed the risk of bias of the included studies. The HR and its 95% CI were used as the effect analysis statistic for survival analysis, while the OR and its 95% CI were used as the effect analysis statistic for dichotomous variables. These statistics were extracted by the reviewers and aggregated using a fixed-effects model to synthesise the data.

RESULTS: A total of 1214 relevant papers were obtained after the initial search, and five papers that met the inclusion criteria were included; these studies included a total of 1856 patients with R/M HNSCC. Meta-analysis showed that the OS and PFS of patients with R/M HNSCC in the combination immunochemotherapy group were significantly longer than those in the conventional chemotherapy group (HR=0.84; 95% CI 0.76, 0.94; p=0.002; HR=0.67; 95% CI 0.61, 0.75; p<0.0001), and the ORR was significantly higher (OR=1.90; 95% CI 1.54, 2.34; p<0.00001). The analysis of AEs showed that there was no significant difference in the overall incidence rate of AEs between two groups (OR=0.80; 95% CI 0.18, 3.58; p=0.77), but the rate of grade III and IV AEs was significantly higher in patients in the combination immunochemotherapy group (OR=1.39; 95% CI 1.12, 1.73; p=0.003).

CONCLUSIONS: Combination immunochemotherapy prolonged OS and PFS in patients with R/M HNSCC and improved the ORR; while this approach did not increase the overall incidence of AEs in patients, it increased the rate of grade III and IV AEs.

PROSPERO REGISTRATION NUMBER: CRD42022344166.

PMID:37311638 | DOI:10.1136/bmjopen-2022-069047

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Approaches to consent in public health research in secondary schools

BMJ Open. 2023 Jun 13;13(6):e070277. doi: 10.1136/bmjopen-2022-070277.

ABSTRACT

OBJECTIVES: We assess different approaches to seeking consent in research in secondary schools.

DESIGN: We review evidence on seeking active versus passive parent/carer consent on participant response rates and profiles. We explore the legal and regulatory requirements governing student and parent/carer consent in the UK.

RESULTS: Evidence demonstrates that requiring parent/carer active consent reduces response rates and introduces selection biases, which impact the rigour of research and hence its usefulness for assessing young people’s needs. There is no evidence on the impacts of seeking active versus passive student consent but this is likely to be marginal when researchers are directly in communication with students in schools. There is no legal requirement to seek active parent/carer consent for children’s involvement in research on non-medicinal intervention or observational studies. Such research is instead covered by common law, which indicates that it is acceptable to seek students’ own active consent when they are judged competent. General data protection regulation legislation does not change this. It is generally accepted that most secondary school students age 11+ are competent to provide their own consent for interventions though this should be assessed individually.

CONCLUSION: Allowing parent/carer opt-out rights recognises their autonomy while giving primacy to student autonomy. In the case of intervention research, most interventions are delivered at the level of the school so consent can only practically be sought from head teachers. Where interventions are individually targeted, seeking student active consent for these should be considered where feasible.

PMID:37311635 | DOI:10.1136/bmjopen-2022-070277

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Prevalence of post-dialysis fatigue: a systematic review and meta-analysis

BMJ Open. 2023 Jun 13;13(6):e064174. doi: 10.1136/bmjopen-2022-064174.

ABSTRACT

OBJECTIVES: The purpose of this study was to synthesise data on the prevalence of post-dialysis fatigue (PDF) among haemodialysis (HD) patients.

DESIGN: Systematic review and meta-analysis.

DATA SOURCES: China National Knowledge Infrastructure, Wanfang, Chinese Biological Medical Database, PubMed, EMBASE and Web of Science were searched from their inception to 1 April 2022.

ELIGIBILITY CRITERIA: We selected patients who must receive HD treatment for at least 3 months. Cross-sectional or cohort studies published in Chinese or English were eligible for inclusion. The main search terms used in the abstract were: “renal dialysis”, “hemodialysis” and “post-dialysis”, in combination with the word “fatigue”.

DATA EXTRACTION AND SYNTHESIS: Two investigators independently performed data extraction and quality assessment. Data were pooled to estimate the overall prevalence of PDF among HD patients using the random-effects model. Cochran’s Q and I2 statistics were adopted to evaluate heterogeneity.

RESULT: A total of 12 studies were included, with 2152 HD patients, of which 1215 were defined as having PDF. The overall prevalence of PDF in HD patients was 61.0% (95% CI: 53.6% to 68.3%, p<0.001, I2=90.0%). Subgroup analysis failed to explain the source of heterogeneity, but univariable meta-regression showed that a mean age of ≥50 years might be the source of heterogeneity. Egger’s test revealed no publication bias among the studies (p=0.144).

CONCLUSIONS: PDF is highly prevalent among HD patients.

PMID:37311633 | DOI:10.1136/bmjopen-2022-064174

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Feasibility and preliminary effectiveness of virtual reality as a patient education tool for people with cancer undergoing immunotherapy: a protocol for a randomised controlled pilot study in a regional setting

BMJ Open. 2023 Jun 13;13(6):e071080. doi: 10.1136/bmjopen-2022-071080.

ABSTRACT

INTRODUCTION: Patient education is a critical component of healthcare delivery. However, medical information and knowledge are complex and can be difficult for patients and families to comprehend when delivered verbally. The use of virtual reality (VR) to convey medical information to patients may bridge this communication gap and lead to more effective patient education. It may be of increased value to those with low health literacy and levels of patient activation, in rural and regional settings. The objective of this randomised, single-centre pilot study is to examine the feasibility and preliminary effectiveness of VR as an education tool for people with cancer. The results will provide data to inform the feasibility of a future randomised controlled trial, including sample size calculations.

METHODS AND ANALYSIS: Patients with cancer undergoing immunotherapy will be recruited. A total of 36 patients will be recruited and randomised to one of three trial arms. Participants will be randomised 1:1:1 to receive VR, a two-dimensional video or standard care (ie, verbal communication and information leaflets). Feasibility will be assessed by recruitment rate, practicality, acceptability, usability and related adverse events. The potential impact of VR on patient-reported outcomes (ie, perceived information provision quality, knowledge about immunotherapy and patient activation) will be assessed and stratified by information coping style (ie, monitors vs blunters) whenever statistical analyses are significant. The patient-reported outcomes will be measured at baseline, post-intervention and 2 weeks post-intervention. In addition, semistructured interviews will be conducted with health professionals and participants randomised to the VR trial arm, to further explore acceptability and feasibility.

ETHICS AND DISSEMINATION: Ethics approval was obtained from the Greater Western Human Research Ethics Committee, New South Wales Local Health District (2022/ETH01760). Informed consent will be obtained from all participants. Findings will be disseminated via relevant conference presentations and publications in peer-reviewed journals.

TRIAL REGISTRATION NUMBER: ACTRN12622001473752.

PMID:37311632 | DOI:10.1136/bmjopen-2022-071080

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Class modelling by Soft Independent Modelling of Class Analogy: why, when, how? A tutorial

Anal Chim Acta. 2023 Aug 22;1270:341304. doi: 10.1016/j.aca.2023.341304. Epub 2023 May 19.

ABSTRACT

This article contains a comprehensive tutorial on classification by means of Soft Independent Modelling of Class Analogy (SIMCA). Such a tutorial was conceived in an attempt to offer pragmatic guidelines for a sensible and correct utilisation of this tool as well as answers to three basic questions: “why employing SIMCA?”, “when employing SIMCA?” and “how employing/not employing SIMCA?”. With this purpose in mind, the following points are here addressed: i) the mathematical and statistical fundamentals of the SIMCA approach are presented; ii) distinct variants of the original SIMCA algorithm are thoroughly described and compared in two different case-studies; iii) a flowchart outlining how to fine-tune the parameters of a SIMCA model for achieving an optimal performance is provided; iv) figures of merit and graphical tools for SIMCA model assessment are illustrated and v) computational details and rational suggestions about SIMCA model validation are given. Moreover, a novel Matlab toolbox, which encompasses routines and functions for running and contrasting all the aforementioned SIMCA versions is also made available.

PMID:37311606 | DOI:10.1016/j.aca.2023.341304

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Causal associations between type 1 diabetes and COVID-19 infection and prognosis: a two-sample Mendelian randomization study

BMJ Open Diabetes Res Care. 2023 Jun;11(3):e003167. doi: 10.1136/bmjdrc-2022-003167.

ABSTRACT

INTRODUCTION: It has been suggested that type 1 diabetes was associated with increased COVID-19 morbidity and mortality. However, their causal relationship is still unclear. Herein, we performed a two-sample Mendelian randomization (MR) to investigate the causal effect of type 1 diabetes on COVID-19 infection and prognosis.

RESEARCH DESIGN AND METHODS: The summary statistics of type 1 diabetes were obtained from two published genome-wide association studies of European population, one as a discovery sample including 15 573 cases and 158 408 controls, and the other data as a replication sample consisting of 5913 cases and 8828 controls. We first performed a two-sample MR analysis to evaluate the causal effect of type 1 diabetes on COVID-19 infection and prognosis. Then, reverse MR analysis was conducted to determine whether reverse causality exists.

RESULTS: MR analysis results showed that the genetically predicted type 1 diabetes was associated with higher risk of severe COVID-19 (OR=1.073, 95% CI: 1.034 to 1.114, pFDR=1.15×10-3) and COVID-19 death (OR=1.075, 95% CI: 1.033 to 1.119, pFDR=1.15×10-3). Analysis of replication dataset showed similar results, namely a positive association between type 1 diabetes and severe COVID-19 (OR=1.055, 95% CI: 1.029 to 1.081, pFDR=1.59×10-4), and a positively correlated association with COVID-19 death (OR=1.053, 95% CI: 1.026 to 1.081, pFDR=3.50×10-4). No causal association was observed between type 1 diabetes and COVID-19 positive, hospitalized COVID-19, the time to the end of COVID-19 symptoms in the colchicine treatment group and placebo treatment group. Reverse MR analysis showed no reverse causality.

CONCLUSIONS: Type 1 diabetes had a causal effect on severe COVID-19 and death after COVID-19 infection. Further mechanistic studies are needed to explore the relationship between type 1 diabetes and COVID-19 infection and prognosis.

PMID:37311601 | DOI:10.1136/bmjdrc-2022-003167

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Psychometric Properties of the Resilience Scale in Older Adults Post-Hip Fracture

J Aging Health. 2023 Jun 13:8982643231184098. doi: 10.1177/08982643231184098. Online ahead of print.

ABSTRACT

Objectives: The purpose of this study was to evaluate the psychometric properties of the modified 25-item Resilience Scale (RS-25) in older adults post-hip fracture using Rasch analysis. Methods: This was a descriptive study using baseline data from the Seventh Baltimore Hip Studies (BHS-7). There were 339 hip fracture patients included in this analysis. Results: Findings suggest there was support for reliability of the measure based on person and item separation index. The INFIT and OUTFIT statistics for testing validity were all in the acceptable range indicating that each item on the modified RS-25 fits the appropriate concept. There was no evidence of Differential Item Functioning (DIF) between genders. Conclusions: This study demonstrated evidence that the modified RS-25 is a reliable and valid measure to evaluate resilience among older adults post-hip fracture and therefore can be used in this population in clinical practice and research.

PMID:37311566 | DOI:10.1177/08982643231184098