Category: Statistics

BMJ Open Qual. 2023 Oct;12(4):e002358. doi: 10.1136/bmjoq-2023-002358.

ABSTRACT

OBJECTIVES: There is little evidence to suggest the best model of palliative and end-of-life care (PEOLC) in an acute care hospital. We introduced a bundle of care to drive improvements in PEOLC; this bundle included three full-time nursing positions providing a palliative care clinical consult service with physician backup, as well as educating staff, using the NSW Resuscitation Plan and the Last-Days-of-Life Toolkit.

METHODS: Two audits were performed at John Hunter Hospital, a tertiary hospital in Newcastle, Australia, each sampling from all deaths in a 12-month period, one prior to and one after the bundle of care was introduced. Sampling was stratified into deaths that occurred within 4-48 hours of admission and after 48 hours. Key outcomes/data points were recorded and compared across the two time periods.

RESULTS: Statistically significant improvements noted included: lower mortality on the wards after 48 hours of admission, better recognition of the dying patient, increased referral to palliative care nurses and physicians, reduction in the number of medical emergency team calls and increase in the use of comfort care and resuscitation plans. Currently, 73% of patients have their end-of-life wishes observed as per their advance care directive.

CONCLUSION: A bundle of care involving dedicated nurses with physician backup providing a consult service and education is an effective method for driving improvements in PEOLC.

PMID:37802540 | DOI:10.1136/bmjoq-2023-002358

Zhongguo Zhen Jiu. 2023 Oct 12;43(10):1175-9. doi: 10.13703/j.0255-2930.20221204-0007.

ABSTRACT

Due to various constraints, such as clinical implementation conditions and unique characteristics of acupuncture-moxibustion, some randomized controlled trials (RCTs) of acupuncture-moxibustion still suffer from relatively low quality and limited applicability. The single-arm objective performance criteria/performance goal can be considered as an ideal supplementary and alternative research approach to RCTs. In this paper, the feasibility of applying the single-arm objective performance criteria/performance goal in acupuncture-moxibustion clinical research is explored from the limitations of conducting acupuncture-moxibustion RCTs, the principles, the essential design considerations and key statistical steps. In addition, illustrative examples are provided. The objective is to offer insights into resolving practical difficulties in acupuncture-moxibustion clinical research.

PMID:37802525 | DOI:10.13703/j.0255-2930.20221204-0007

Zhongguo Zhen Jiu. 2023 Oct 12;43(10):1151-6. doi: 10.13703/j.0255-2930.20221111-k0004.

ABSTRACT

OBJECTIVE: To observe the effect of electroacupuncture (EA) at “Neiguan” (PC 6) on myocardial fibrosis in spontaneously hypertensive rats (SHR), and explore preliminarily the mediating role of cholinergic anti-inflammatory pathway (CAP) and its downstream nuclear factor κB (NF-κB) signaling pathway.

METHODS: Six 12-week-old WKY male rats were employed as the normal group. Eighteen 12-week-old SHR were randomly divided into 3 groups, i.e. a model group, an EA group and a blocking group (EA after blocking α7 nicotinic acetylcholine receptor [α7nAchR]), with 6 rats in each one. In the EA group, EA was delivered at “Neiguan”(PC 6) and the site 0.5 cm from its left side, with disperse-dense wave, 2 Hz/15 Hz in frequency and 1 mA in current intensity. One intervention took 30 min and was given once every 2 days, lasting 8 weeks. In the blocking group, prior to each EA, the α7nAchR specific blocker, α-bungartoxin was injected intravenously in the tails of the rats. After EA intervention, the systolic blood pressure (SBP), the diastolic blood pressure (DBP) and the mean arterial pressure (MAP) were measured with non-invasive blood pressure monitor. Using echocardiogram, the left ventricular (LV) anterior wall end-diastolic thickness (LVAWd) , LV posterior wall end-diastolic thickness (LVPWd) and the LV end-diastolic internal diameter (LVIDd) were measured. The level of hydroxyproline (Hyp) in the myocardial tissue was determined by using alkaline hydrolysis, and that of acetylcholine (Ach) was detected by ELISA. With the real-time PCR adopted, the mRNA expression of NF-κB p65, tumor necrosis factor α (TNF-α), interleukin (IL)-1β and IL-6 were determined.

RESULTS: Compared with the normal group, SBP, DBP, MAP, LVAWd and LVPWd were increased (P<0.01), and LVIDd was decreased (P<0.01) in the rats of the model group. SBP, DBP, MAP and LVAWd were dropped (P<0.01, P<0.05), and LVIDd rose (P<0.01) in the EA group when compared with those in the model group. The differences in the above indexes were not statistically significant between the blocking group and the model group (P>0.05). Compared with the normal group, Hyp level and the mRNA expression of NF-κB p65, TNF-α, IL-1β and IL-6 in the myocardial tissue increased (P<0.01, P<0.05) and Ach level decreased (P<0.01) in the model group. Hyp level, the mRNA expression of NF-κB p65, TNF-α, IL-1β and IL-6 in the myocardial tissue were reduced (P<0.05, P<0.01) and Ach level rose (P<0.01) in the EA group when compared with those in the model group. These indexes were not different statistically between the blocking group and the model group (P>0.05).

CONCLUSION: CAP may be involved in ameliorating the pathological damage of myocardial fibrosis during EA at “Neiguan”(PC 6). The underlying effect mechanism is associated with up-regulating the neurotransmitter, Ach and down-regulating mRNA expression of NF-κB p65 and pro-inflammatory factors such as TNF-α, IL-1β and IL-6 in myocardial tissue.

PMID:37802521 | DOI:10.13703/j.0255-2930.20221111-k0004

Zhongguo Zhen Jiu. 2023 Oct 12;43(10):1109-13. doi: 10.13703/j.0255-2930.20230131-0002.

ABSTRACT

OBJECTIVE: To compare the curative effect between interactive scalp acupuncture and traditional scalp acupuncture on hemiplegic upper extremity motor dysfunction in the patients with ischemic stroke.

METHODS: Seventy cases of hemiplegic upper extremity motor dysfunction of ischemic stroke were randomly divided into an interactive scalp acupuncture group (35 cases, 1 case breaked off) and a traditional scalp acupuncture group (35 cases, 1 case dropped off). The patients of the two groups received the secondary prevention medication and routine rehabilitation therapy. Besides, in the interactive scalp acupuncture group, the upper extremity occupational therapy was operated during the needle retaining of scalp acupuncture; and in the traditional scalp acupuncture group, the upper extremity occupational therapy was delivered after the completion of scalp acupuncture. The same points were selected in the two groups such as Fuxiang head area, Fuxiang upper-limb-shoulder point, Fuxiang upper-limb-elbow point and Fuxiang upper-limb-wrist point. The needles were inserted perpendicularly by flying-needle technique and manipulated by triple technique of gentle twisting, heavy pressure and vibrating. The needles were retained for 30 min. Based on the degree of the upper extremity motor impairment, the regimen of the upper extremity occupational therapy was formulated individually and one treatment took 30 min. In the two groups, the therapies were delivered once daily, 5 times a week, lasting 4 weeks. Before and after treatment, the scores of Fugl-Meyer assessment of upper extremity (FMA-UE), Wolf motor function test (WMFT), the modified Barthel index (MBI) and the modified Ashworth scale (MAS) grade in the two groups were observed before and after treatment.

RESULTS: After treatment, the scores of FMA-UE, WMFT and MBI were higher than those before treatment (P<0.01), and MAS grade was improved (P<0.05) in the two groups. The scores of FMA-UE, WMFT and MBI in the interactive scalp acupuncture group were higher than those in the traditional scalp acupuncture group (P<0.01, P<0.05), and there was no statistical significance in the difference of MAS grade between the two groups (P>0.05).

CONCLUSION: The interactive scalp acupuncture can effectively improve the motor function of the hemiplegic upper extremities and the activities of daily living in the patients with ischemic stroke and its efficacy is better than traditional scalp acupuncture. But these two types of scalp acupuncture obtain the similar effect on spasticity.

PMID:37802514 | DOI:10.13703/j.0255-2930.20230131-0002

J Allergy Clin Immunol. 2023 Oct 4:S0091-6749(23)01248-4. doi: 10.1016/j.jaci.2023.09.036. Online ahead of print.

ABSTRACT

BACKGROUND: Racial and ethnic disparities in life expectancy in the U.S. have been widely documented. To date, there remains a paucity of similar data in patients with inborn errors of immunity (IEI).

OBJECTIVE: To examine racial and ethnic differences in IEI mortality in the U.S.

METHODS: We analyzed the National Center for Health Statistics national mortality data from 2013 to 2018. We quantified age-adjusted death rate (ADR) and age-specific death rate (ASDR) from IEI for each major racial and ethnic group in the U.S, and examined the association of race and ethnicity with death at a younger age. For detailed Methods, please see the Methods section in this article’s Online Repository at www.jacionline.org.

RESULTS: During 2003 to 2018, IEI was reported as the underlying or contributing cause of death in 14,970 individuals nationwide. ADR was highest among Black patients (4.25 per 1,000,000 person-years), compared with 2.01, 1.71, 1.50, and 0.92 per 1,000,000 person-years for White, American Indian/Alaska Native (AIAN), Hispanic, and Asian/Pacific Islander (API) patients, respectively. Odds of death before age 65 years was greatest among Black patients (OR 5.15; 95% CI 4.61-5.76), followed by AIAN patients (OR 3.58; 95% CI 2.30-5.82), compared with White patients. Odds of death before age 24 years was greatest among Hispanic patients, compared with non-Hispanic patients (OR 3.60; 95% CI 3.08-4.18).

CONCLUSION: Our study highlights racial and ethnic disparities in IEI mortality and the urgent need to further identify and systematically remove barriers in care for historically marginalized patients with IEI.

PMID:37802474 | DOI:10.1016/j.jaci.2023.09.036

J Infect. 2023 Oct 4:S0163-4453(23)00515-7. doi: 10.1016/j.jinf.2023.09.013. Online ahead of print.

NO ABSTRACT

PMID:37802470 | DOI:10.1016/j.jinf.2023.09.013

Pharmacol Res. 2023 Oct 4:106949. doi: 10.1016/j.phrs.2023.106949. Online ahead of print.

ABSTRACT

OBJECTIVES: A cost-utility analysis was conducted to evaluate pharmacogenomic (PGx)-guided treatment compared to the standard-of-care intervention among patients diagnosed with colorectal cancer (CRC) in Italy.

METHODS: Data derived from a prospective, open-label, block randomized clinical trial, as a part of the largest PGx study worldwide (355 patients in both arms) were used. Mortality was used as the primary health outcome to estimate life years (LYs) gained in treatment arms within a survival analysis context. PGx-guided treatment was based on established drug-gene interactions between capecitabine, 5-fluorouracil and irinotecan with DPYD and/or UGT1A1 genomic variants. Utility values for the calculation of Quality Adjusted Life Year (QALY) was based on Visual Analog Scale (VAS) score. Missing data were imputed via the Multiple Imputation method and linear interpolation, when possible, while censored cost data were corrected via the Replace-From-The-Right algorithm. The Incremental Cost-Effectiveness Ratio (ICER) was calculated for QALYs. Raw data were bootstrapped 5,000 times in order to produce 95% Confidence Intervals based on non-parametric percentile method and to construct a cost-effectiveness acceptability curve. Cost differences for study groups were investigated via a generalized linear regression model analysis. Total therapy cost per patient reflected all resources expended in the management of any adverse events, including medications, diagnostics tests, devices, surgeries, the utilization of intensive care units, and wards.

RESULTS: The total cost of the study arm was estimated at €380 (~ US$416; 95%CI: 195-596) compared to €565 (~ US$655; 95%CI: 340-724) of control arm while the mean survival in study arm was estimated at 1.58 (+0.25) LYs vs 1.50 (+0.26) (Log Rank test, X2=4.219, df=1, p-value=0.04). No statistically significant difference was found in QALYs. ICER was estimated at €13418 (~ US$14695) per QALY, while the acceptability curve indicated that when the willingness-to-pay was under €5000 (~ US$5476), the probability of PGx being cost-effective overcame 70%. The most frequent adverse drug event in both groups was neutropenia of severity grade 3 and 4, accounting for 82.6% of total events in the study arm and 65.0% in the control arm. Apart from study arm, smoking status, Body-Mass-Index and Cumulative Actionability were also significant predictors of total cost. Subgroup analysis conducted in actionable patients (7.9% of total patients) indicated that PGx-guided treatment was a dominant option over its comparator with a probability greater than 92%. In addition, a critical literature review was conducted, and these findings are in line with those reported in other European countries.

CONCLUSION: PGx-guided treatment strategy may represent a cost-saving option compared to the existing conventional therapeutic approach for colorectal cancer patient management in the National Health Service of Italy.

PMID:37802427 | DOI:10.1016/j.phrs.2023.106949

Ophthalmology. 2023 Oct 4:S0161-6420(23)00710-8. doi: 10.1016/j.ophtha.2023.09.031. Online ahead of print.

ABSTRACT

OBJECTIVES: To compare topical PHMB (polihexanide) 0.02% (0.2 mg/ml) + propamidine 0.1% (1 mg/ml) [PHMB 0.02%+propamidine] to PHMB 0.08% (0.8 mg/ml) with placebo [PHMB 0.08%] for Acanthamoeba keratitis (AK) treatment.

DESIGN: Prospective randomized, double-masked, active-controlled, multicentre, Phase3 study (ClinicalTrials.gov NCT03274895).

PARTICIPANTS: 135 at six European centres between 08/17/2017 to 06/18/2021.

METHODS: Principal inclusion criteria: ≥12 years old; in vivo confocal microscopy (IVCM) with clinical findings consistent with AK. Also included were participants with concurrent bacterial keratitis, using topical steroids, antiviral and antifungal drugs before randomisation. Principal exclusions: concurrent herpes or fungal keratitis, use of anti-amoebic therapy (AAT).

RANDOMISATION: 1:1 computer-generated, block size 4. This was a superiority trial having a predefined non-inferiority margin. The sample size of 130 participants gave approximately 80% power to detect 20 percentage point superiority for PHMB 0.08% for the primary outcome of the medical cure rate (without surgery or change of AAT) within 12 months (MCR_12), cure defined by clinical criteria 90 days after discontinuing anti-inflammatories and AAT. A prespecified multivariable analysis adjusted for baseline imbalances in risk factors affecting outcomes.

MAIN OUTCOME MEASURES: The MCR_12. Secondary outcomes included best-corrected visual acuity (BCVA) and treatment failure rates. Safety outcomes included adverse event rates.

RESULTS: 135 participants were randomised providing 127 in the full analysis subset (61 on PHMB 0.02%+propamidine and 66 on PHMB 0.08%) and 134 in the safety analysis subset. The adjusted MCR_12 was 86.6% (unadjusted 88.5%) for PHMB 0.02%+propamidine and 86.7% (unadjusted 84.9%) for PHMB 0.08%; the non-inferiority requirement for PHMB 0.08% was met (adjusted difference 0.1 percentage points, lower one-sided 95% confidence limit -8.3 percentage points). Secondary outcomes were similar for both treatments and not analysed statistically: median BCVA of 20/20, an overall treatment failure rate of 17/127 (13.4%) of whom 8/127 (6.3%) required therapeutic keratoplasty. There were no serious drug related adverse events.

CONCLUSIONS: PHMB 0.08% monotherapy may be as effective (or at worse only eight percentage points less effective) as dual therapy with PHMB 0.02%+propamidine (a widely used therapy) with medical cure rates of >86%, when used with the Trial treatment delivery protocol, in AK populations with similar disease severity.

PMID:37802392 | DOI:10.1016/j.ophtha.2023.09.031

Sci Total Environ. 2023 Oct 4:167567. doi: 10.1016/j.scitotenv.2023.167567. Online ahead of print.

ABSTRACT

The aim of this research was to examine how particulate matter (PM) pollution affects the life history of the two-spotted spider mite (TSSM), Tetranychus urticae (Trombidiformes: Tetranychidae), in modelled urban conditions. For this purpose, experimental populations of TSSM were cultured on the foliage of small-leaved lime (Tilia cordata) contaminated with PM at intensities corresponding to differing city zones such as a park, a busy road and an industrial area. The control samples in the study were washed, unpolluted leaves. The spider mite was selected as a model organism due to its cosmopolitan distribution, broad host spectrum, resistance to a variety of pesticides and food-intake mode involving cell-content sucking, while T. cordata is widely planted in cities and has demonstrated a considerable capability for PM capture. Data on the longevity and mortality of particular instars and on female fecundity at different pollution levels were collected and statistically evaluated. Concentrations of PM typical for roads and industrial city zones significantly reduced total female fecundity (avg. 53.9 and 55.9 eggs/female, respectively, vs 79.2 in control), which entailed a slower population increase, while the survival rate of particular developmental instars (P = 0.52) and fertility curves (P = 0.19) remained unchanged. The presence of PM caused physiological effects in the mites, despite the lack of direct consumption of the pollutant by adult and juvenile instars. Considering the incomparable resilience of TSSM to unfavourable environmental factors, it is predicted that the detrimental influence of PM on other representatives of urban arthropods may be even more severe. The results suggest that there is a need for further investigations into the ecological ramifications of air purification provided by urban green spaces.

PMID:37802333 | DOI:10.1016/j.scitotenv.2023.167567

J Subst Use Addict Treat. 2023 Oct 4:209180. doi: 10.1016/j.josat.2023.209180. Online ahead of print.

ABSTRACT

BACKGROUND: Sleep disturbance is commonly reported among individuals meeting criteria for cannabis use disorder (CUD), and cannabis users frequently report sleep disturbance as a contributor to failed quit attempts. The purpose of this study was to measure sleep in individuals enrolled in treatment for CUD, and to determine whether use of hypnotic medication during treatment increased abstinence rates.

METHOD: The study enrolled 127 adults seeking treatment for CUD in a 12-week clinical trial and randomized to receive extended-release zolpidem (zolpidem-XR) or placebo. All participants received computerized behavioral therapy and abstinence-based contingency management. The study conducted in-home ambulatory polysomnography (PSG) assessments at baseline and during treatment to objectively measure sleep. Self-report measures of recent sleep, Insomnia Severity Index (ISI), and drug use (Timeline Follow-Back) were collected at each study visit, and the study confirmed self-reported abstinence via quantitative urine drug testing.

RESULT: Participants randomized to placebo, but not zolpidem-XR exhibited significant sleep disturbance during week 1 of treatment. Sleep disturbance emerged in the zolpidem-XR group after study medication was stopped at the end of treatment. Though participants assigned to the zolpidem-XR condition had qualitatively greater rates of abstinence compared with placebo (27 % versus 15 % negative at end of treatment), the difference was not statistically significant. Treatment retention was poor (about 50 % drop out in both groups) and medication adherence was a challenge without the use of contingent incentives.

CONCLUSION: Results from this randomized controlled trial suggest that zolpidem-XR can attenuate abstinence-induced sleep disturbance early in treatment for CUD, but that sleep problems are likely to emerge after the medication is stopped. Further research should identify alternative pharmacotherapies and behavioral treatments for CUD and elucidate the role of sleep disturbance in the development and maintenance of CUD.

PMID:37802317 | DOI:10.1016/j.josat.2023.209180