Category: Statistics

Gastroenterol Nurs. 2021 Apr 26. doi: 10.1097/SGA.0000000000000542. Online ahead of print.

ABSTRACT

The aim of this research study was to evaluate the effectiveness of lidocaine versus lidocaine with sodium bicarbonate in reducing anxiety and pain, using visual analog scales, in subjects receiving local anesthetic during liver biopsies. The project included 199 subjects presenting for percutaneous liver biopsy using local anesthesia. Subjects were randomized into 2 groups: the control group, which received lidocaine alone, and the experimental group, which received lidocaine buffered with sodium bicarbonate. Immediately after they received the lidocaine injection, both groups were asked to rate their preprocedure anxiety and pain using a 0-10 visual analog scale. Mean postprocedure pain was statistically significantly different between the two arms with the intervention group reporting less pain (1.65 vs. 2.27, p = .037). Change in pain scores between the two groups were also statistically significantly different with the intervention group reporting a mean change in pain score of 0.93 compared to 1.63 in the control group (p = .021). However, no differences were found for reported anxiety. This study has shown that using sodium bicarbonate with lidocaine significantly decreased pain sensation at the injection site when used for deep visceral anesthesia during percutaneous liver biopsy.

PMID:33927155 | DOI:10.1097/SGA.0000000000000542

Epidemiology. 2021 Apr 12. doi: 10.1097/EDE.0000000000001363. Online ahead of print.

ABSTRACT

BACKGROUND: Important questions exist regarding the comparative effectiveness of alternative childhood vaccine schedules; however, optimal approaches to studying this complex issue are unclear.

METHODS: We applied methods for studying dynamic treatment regimens to estimate the comparative effectiveness of different rotavirus vaccine (RV) schedules for preventing acute gastroenteritis-related emergency department visits or hospitalization. We studied the effectiveness of six separate protocols: one- and two-dose monovalent rotavirus vaccine (RV1); one-, two-, and three-dose pentavalent rotavirus vaccine (RV5); and no RV vaccine. We used data on all infants to estimate the counterfactual cumulative risk for each protocol. Infants were censored when vaccine receipt deviated from the protocol. Inverse probability of censoring-weighted estimation addressed potentially informative censoring by protocol deviations. A non-parametric group-based bootstrap procedure provided statistical inference.

RESULTS: The method yielded similar 2-year effectiveness estimates for the full-series protocols; weighted risk difference estimates comparing unvaccinated children to those adherent to either full-series (two-dose RV1, three-dose RV5) corresponded to four fewer hospitalizations and 12 fewer emergency department visits over the 2-year period per 1,000 children. We observed dose-response relationships, such that additional doses further reduced risk of acute gastroenteritis. Under a theoretical intervention to fully vaccinate all children, the 2-year risk differences comparing full to observed adherence were 0.04% (95% CI: 0.03%, 0.05%) for hospitalizations and 0.17% (95% CI: 0.14%, 0.19%) for emergency department visits.

CONCLUSIONS: The proposed approach can generate important evidence about the consequences of delaying or skipping vaccine doses, and the impact of interventions to improve vaccine schedule adherence.

PMID:33927157 | DOI:10.1097/EDE.0000000000001363

Crit Care Med. 2021 Apr 30. doi: 10.1097/CCM.0000000000005065. Online ahead of print.

ABSTRACT

OBJECTIVES: To investigate whether intervention effect estimates for mortality differ between blinded and nonblinded randomized controlled trials conducted in critical care. We used a meta-epidemiological approach, comparing effect estimates between blinded and nonblinded randomized controlled trials for the same research question.

DATA SOURCES: Systematic reviews and meta-analyses of randomized controlled trials evaluating a therapeutic intervention on mortality in critical care, published between January 2009 and March 2019 in high impact factor general medical or critical care journals and by Cochrane.

DATA EXTRACTION: For each randomized controlled trial included in eligible meta-analyses, we evaluated whether the trial was blinded (i.e., double-blinded and/or reporting adequate methods) or not (i.e., open-label, single-blinded, or unclear). We collected risk of bias evaluated by the review authors and extracted trial results.

DATA SYNTHESIS: Within each meta-analysis, we compared intervention effect estimates between blinded and nonblinded randomized controlled trials by using a ratio of odds ratio (< 1 indicates larger estimates in nonblinded than blinded randomized controlled trials). We then combined ratio of odds ratios across meta-analyses to obtain the average relative difference between nonblinded and blinded trials. Among 467 randomized controlled trials included in 36 meta-analyses, 267 (57%) were considered blinded and 200 (43%) nonblinded. Intervention effect estimates were statistically significantly larger in nonblinded than blinded trials (combined ratio of odds ratio, 0.91; 95% CI, 0.84-0.99). We found no heterogeneity across meta-analyses (p = 0.72; I2 = 0%; τ2 = 0). Sensitivity analyses adjusting the main analysis on risk of bias items yielded consistent results.

CONCLUSIONS: Intervention effect estimates of mortality were slightly larger in nonblinded than blinded randomized controlled trials conducted in critical care, but confounding cannot be excluded. Blinding of both patients and personnel is important to consider when possible in critical care trials, even when evaluating mortality.

PMID:33927122 | DOI:10.1097/CCM.0000000000005065

Am J Gastroenterol. 2021 Apr 29. doi: 10.14309/ajg.0000000000001272. Online ahead of print.

ABSTRACT

INTRODUCTION: In patients with cirrhosis, highly prevalent vitamin D deficiency and low bone mineral density (BMD) increase the burden of disease, and role of vitamin D supplementation is not clear. So, our aim was to determine the effect of vitamin D supplementation on vitamin D level and BMD in patients with cirrhosis.

METHODS: Patients with cirrhosis (18-60 years) of any etiology were enrolled. We measured serum 25(OH)D, parathyroid hormone, thyroid-stimulating hormone, free T4, bone-specific alkaline phosphatase, insulin-like growth factor (IGF)-1, and health-related quality of life at entry and at 1 year; however, serum calcium was measured at 3-month interval. BMD was measured by dual-energy x-ray absorptiometry at lumbar spine and left hip neck at entry and after 1 year. Statistical analysis was performed according to intention-to-treat analysis.

RESULTS: Of 390 screened patients with cirrhosis, 164 participants (82 in each group) were randomized. There was significant increase in 25(OH)D levels in intervention group after 1 year (33.7 [24.3-45.7] ng/mL vs 23.1 [17-28.2] ng/mL; P < 0.001) when compared with placebo. The mean difference in BMD at lumbar spine and left hip neck was not significantly changed after 1 year of intervention with vitamin D between both groups. There was no significant change in both the groups in levels of calcium, thyroid-stimulating hormone, parathyroid hormone, free T4, IGF-1, and bone-specific alkaline phosphatase and quality of life.

DISCUSSION: Supplementation with vitamin D for 1 year improves vitamin D levels but did not result in improvement in BMD at lumbar spine and left hip neck in patients with cirrhosis.

PMID:33927126 | DOI:10.14309/ajg.0000000000001272

Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2021 Mar 28;46(3):293-299. doi: 10.11817/j.issn.1672-7347.2021.190795.

ABSTRACT

OBJECTIVES: The waiting room for surgery is an area set up to improve the surgical turnover rate, but the waiting time for surgery is uncertain. Patients are prone to negative emotions that affect their physiological state during waiting time. This study aims to explore the effect of Mandala painting intervention based on Mandala-self theory on the emotion and physiological state of patients waiting before operation.

METHODS: The patients in the control group (n=30) were given routine nursing before operation in the waiting room, and the patients in the intervention group (n=30) were given Mandala painting intervention on the basis of routine nursing. Repeated measurement analysis of variance was used to compare patients’ mood, pressure, heart rate, and waiting time of perception after intervention via SPSS 21.0.

RESULTS: Diastolic pressure, heart rate, and happiness and excitement showed no statistical significance in the time effect, intervention effect, and interaction between the 2 factors (all P>0.05). Systolic pressure, fidgety, and pain and sadness showed interaction between the time effect and intervention effect (P<0.05 or P<0.01). The waiting time of perception in the intervention group was significantly shorter than that in the control group (P<0.01).

CONCLUSIONS: The application of Mandala painting in the operation waiting room is feasible and can effectively regulate the patients’ negative mood and systolic pressure, as well as shorten the waiting time of perception.

PMID:33927077 | DOI:10.11817/j.issn.1672-7347.2021.190795

AIDS. 2021 Apr 28. doi: 10.1097/QAD.0000000000002930. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the long-term risks of type 2 diabetes mellitus (T2DM) and cardiovascular disease secondary to weight gain and clinical obesity associated with the initiation of integrase strand transfer inhibitors (INSTIs) and tenofovir alafenamide (TAF) in the ADVANCE trial using validated risk equation tools.

DESIGN: Retrospective data analysis.

METHODS: In ADVANCE, 1,053 treatment-naïve participants in South Africa (99% black, 59% female) were randomized to 96 weeks of tenofovir alafenamide/ emtricitabine + dolutegravir (TAF/FTC+DTG), tenofovir disoproxil fumarate/ emtricitabine + dolutegravir (TDF/FTC+DTG), or tenofovir disoproxil fumarate/ emtricitabine + efavirenz (TDF/FTC/EFV). The 5- and 10-year risks of CVD were calculated using D:AD, QRISK and Framingham, and T2DM risk using QDiabetes, Cambridge Diabetes and Leicester Practice Risk scores. Participants were included in this analysis if they were above 30 years old at baseline.

RESULTS: 217 (TAF/FTC+DTG), 218 (TDF/FTC+DTG), and 215 (TDF/FTC/EFV) participants had 96-week data available. Weight gain was +8.1 kg, +4.2 kg, and +2.4 kg on TAF/FTC+DTG, TDF/FTC+DTG, and TDF/FTC/EFV, respectively. Participants on TAF/FTC+DTG had greatest risk scores for CVD (using QRISK) and T2DM, driven by weight changes. Differences were statistically significant between TAF/FTC+DTG and TDF/FTC/EFV for CVD risk using the QRISK equation, equivalent to 1 extra case per 1,000 people treated over 10 years, and between all treatment groups for T2DM risk. Six extra T2DM cases were predicted on TAF/FTC+DTG vs TDF/FTC+DTG using QDiabetes.

CONCLUSION: Obesity, especially with TAF/FTC+DTG, drove increased risk of T2DM, with some evidence of greater CVD risk. However, predictive tools have not been validated in the HIV-positive and black African population.

PMID:33927086 | DOI:10.1097/QAD.0000000000002930

Dermatol Surg. 2021 Apr 27. doi: 10.1097/DSS.0000000000003062. Online ahead of print.

ABSTRACT

BACKGROUND: The reallocation of health care resources to focus on the acute care needs of COVID-19 patients leads to a delay and deferral of outpatient surgical procedures such as Mohs surgery.

OBJECTIVE: Planning for the resumption of regular outpatient surgical care and preparing for future surges in COVID-19 cases requires identifying surrogate markers of health care demand.

MATERIALS AND METHODS: United States national and state-based Google search data for “Mohs surgery” and other common elective surgical and cosmetic procedures were evaluated. These were compared with national and state-wide COVID-19 case number and death data from the Johns Hopkins University. Pearson correlation coefficients were generated to assess the association between COVID-19 cases and deaths with Google search trends.

RESULTS: Search volume for “Mohs surgery” and other elective surgical and cosmetic procedures significantly decreased as the number of new deaths from COVID-19 increased. Statistically significant inverse correlation was noted between “Mohs surgery” search volume and new COVID-19 deaths on a national and state-based level.

CONCLUSION: Search metric analysis may be used as part of a big data model to help predict health care demand during the reopening phase of the COVID-19 pandemic.

PMID:33927090 | DOI:10.1097/DSS.0000000000003062

Curr Opin Urol. 2021 Apr 28. doi: 10.1097/MOU.0000000000000884. Online ahead of print.

ABSTRACT

PURPOSE OF REVIEW: Artificial intelligence has become popular in medical applications, specifically as a clinical support tool for computer-aided diagnosis. These tools are typically employed on medical data (i.e., image, molecular data, clinical variables, etc.) and used the statistical and machine-learning methods to measure the model performance. In this review, we summarized and discussed the most recent radiomic pipeline used for clinical analysis.

RECENT FINDINGS: Currently, limited management of cancers benefits from artificial intelligence, mostly related to a computer-aided diagnosis that avoids a biopsy analysis that presents additional risks and costs. Most artificial intelligence tools are based on imaging features, known as radiomic analysis that can be refined into predictive models in noninvasively acquired imaging data. This review explores the progress of artificial intelligence-based radiomic tools for clinical applications with a brief description of necessary technical steps. Explaining new radiomic approaches based on deep-learning techniques will explain how the new radiomic models (deep radiomic analysis) can benefit from deep convolutional neural networks and be applied on limited data sets.

SUMMARY: To consider the radiomic algorithms, further investigations are recommended to involve deep learning in radiomic models with additional validation steps on various cancer types.

PMID:33927099 | DOI:10.1097/MOU.0000000000000884

BMJ Mil Health. 2021 Apr 29:bmjmilitary-2021-001783. doi: 10.1136/bmjmilitary-2021-001783. Online ahead of print.

ABSTRACT

INTRODUCTION: The conflicts in Iraq and Afghanistan resulted in large numbers of personnel sustaining extremity injuries. In the context of polytrauma, partial hand amputation is often unrecorded. The aim of this work was to quantify the burden of upper limb (UL) amputation at any level occurring concurrently with a major (ankle and proximal) lower limb (LL) amputation. Knowledge of this cohort could aid in prosthetic modification to further improve quality of life outcomes in a population with dexterity loss.

METHOD: A trauma database search was undertaken for all UK military LL amputees from the conflicts in Iraq and Afghanistan. A manual search method was employed to identify from the major LL amputees those who had a concurrent UL amputation at any level (including isolated finger amputation). Demographics, level of amputation, and injury profile data were recorded.

RESULTS: Sixty-eight individuals were identified; the most prevalent population was bilateral LL with a unilateral UL amputation (60%). Most UL amputations were partial hand (75%). The was no statistically significant difference between left or right side (p=0.13). On the left side, correlation was found between amputation of the thumb and third digit (rho=0.34; p=0.005) not seen on the right.

CONCLUSION: We have determined the rate of UL amputation at any level, in combination with LL amputation as a result of blast injury. Knowledge of these combinations enables further research to support anecdotal evidence that there is a need for tailored prosthetics in the context of potential dexterity loss making donning and doffing problematic.

PMID:33927000 | DOI:10.1136/bmjmilitary-2021-001783

Int J Med Educ. 2021 Apr 29;12:76-83. doi: 10.5116/ijme.606a.f16c.

ABSTRACT

OBJECTIVES: We aimed to explore empathy, moral competencies, callous traits, and temperament in a sample of medical students. Furthermore, we aimed to investigate differences in our variables across the 1st and 5th years of medical education and possible correlations between them.

METHODS: This was a cross-sectional study with 138 medical students. We resorted to self-reported instruments that were given at the end of classes: Barrett-Lennard Relational Inventory, Temperament Evaluation of Memphis, Pisa and San Diego Auto-questionnaire, Inventory of Callous-Unemotional Traits, and Moral Competence Test. For the statistical analysis, we resorted to descriptive and inferential statistics, using non-parametric tests when data didn’t follow a normal distribution.

RESULTS: We found no statistical difference between empathy scores in 1st (N=104, Mean=41.42, SD=22.48) and 5th year students (N=34, Mean=37.35, SD=23.35), t₍₁₃₆₎=0.908, p=0.366. Callous traits were negatively correlated with empathy (r₍₁₃₆₎=-0.444, p=0.000) and no correlation between moral competences and empathy (r₍₉₆₎=0.029, p=0.779) was observed. We found a negative correlation between empathy and cyclothymic, anxious and irritable temperaments (r₍₁₃₆₎=-0.334, p=0.000, r₍₁₃₆₎=-0.281, p=0.001, r₍₁₃₆₎=-0.400, p=0.000).

CONCLUSIONS: Our scores corroborate previous evidence that medical students are empathic, have good moral standards and low callous traits. We saw no differences in empathy scores between the two years and future studies could explore the particulars of medical curriculums impacting this variable. In our study, empathy was negatively correlated with callous traits and linked with specific temperaments. Considering these variables at admission to medical school as well as preserving and improving them in medical education might offer better standards of care.

PMID:33927064 | DOI:10.5116/ijme.606a.f16c