Tag: pubmed

JMIR Serious Games. 2022 Nov 23;10(4):e36695. doi: 10.2196/36695.

ABSTRACT

BACKGROUND: Extreme labor pain has negative effects; pharmacologic analgesic modalities are effective but are accompanied by adverse effects. Virtual reality (VR) works as a distracting nonpharmacologic intervention for pain and anxiety relief; however, the effects of VR use in laboring women is unknown.

OBJECTIVE: Our study aimed to determine the safety and effectiveness of VR technology during labor and delivery and investigate whether it impacts labor and patient satisfaction.

METHODS: In all, 7 databases (PubMed, Embase, Web of Science, the Cochrane Library, CINAHL, China National Knowledge Infrastructure, and Wan-Fang Database) were systematically searched for randomized controlled trials of VR use in pregnancy and childbirth from the time of database construction until November 24, 2021. Two researchers extracted data and evaluated study quality using the Cochrane Risk of Bias tool 2.0. Outcome measures were labor pain, anxiety, duration, satisfaction, and adverse events. Meta-analyses were performed where possible.

RESULTS: A total of 12 studies with 1095 participants were included, of which 1 and 11 studies were rated as “Low risk” and “Some concerns” for risk of bias, respectively. Of the 12 studies, 11 reported labor pain, 7 reported labor anxiety, and 4 reported labor duration. Meta-analysis revealed that VR use could relieve pain during labor (mean difference -1.81, 95% CI -2.04 to -1.57; P<.001) and the active period (standardized mean difference [SMD] -0.41, 95% CI -0.68 to -0.14; P=.003); reduce anxiety (SMD -1.39, 95% CI -1.99 to -0.78; P<.001); and improve satisfaction with delivery (relative risk 1.32, 95% CI 1.10-1.59; P=.003). The effects of VR on the duration of the first (SMD -1.12, 95% CI -2.38 to 0.13; P=.08) and second (SMD -0.22, 95% CI -0.67 to 0.24; P=.35) stages of labor were not statistically significant.

CONCLUSIONS: VR is safe and effective in relieving maternal labor pain and anxiety; however, due to the heterogeneity among studies conducted to date, more rigorous, large-scale, and standardized randomized controlled trials are required to provide a higher-quality evidence base for the use of VR technology in maternal labor, with the aim of improving experience and outcomes.

TRIAL REGISTRATION: PROSPERO CRD42021295410; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=295410.

PMID:36416881 | DOI:10.2196/36695

JAMA Oncol. 2022 Nov 23. doi: 10.1001/jamaoncol.2022.5486. Online ahead of print.

ABSTRACT

IMPORTANCE: A key issue for the adjuvant treatment of patients with melanoma is the assessment of the effect of treatment on relapse, survival, and quality of life (QOL).

OBJECTIVE: To compare QOL in patients with resected melanoma at high risk for relapse who were treated with adjuvant pembrolizumab vs standard of care with either ipilimumab or high-dose interferon α 2b (HDI).

DESIGN, SETTING, AND PARTICIPANTS: The S1404 phase 3 randomized clinical trial was conducted by the SWOG Cancer Research Network at 211 community/academic sites in the US, Canada, and Ireland. Patients were enrolled from December 2015 to October 2017. Data analysis for this QOL substudy was completed in March 2022. Overall, 832 patients were evaluable for the primary QOL end point.

INTERVENTIONS: Patients were randomized (1:1) to treatment with adjuvant pembrolizumab vs standard of care with ipilimumab/HDI.

MAIN OUTCOMES AND MEASURES: Quality of life was assessed for patients at baseline and cycles 1, 3, 5, 7, and 9 after randomization using the Functional Assessment of Cancer Therapy (FACT) Biological Response Modifiers (FACT-BRM), FACT-General, Functional Assessment of Chronic Illness Therapy-Diarrhea, and European QOL 5-Dimension 3-Level scales. The primary end point was the comparison by arm of cycle 3 FACT-BRM trial outcome index (TOI) scores using linear regression. Linear-mixed models were used to evaluate QOL scores over time. Regression analyses included adjustments for the baseline score, disease stage, and programmed cell death ligand 1 status. A clinically meaningful difference of 5 points was targeted.

RESULTS: Among 1303 eligible patients (median [range] age, 56.7 [18.3-86.0] years; 524 women [40.2%]; 779 men [59.8%]; 10 Asian [0.8%], 7 Black [0.5%], 44 Hispanic [3.4%], and 1243 White [95.4%] individuals), 1188 (91.1%) had baseline FACT-BRM TOI scores, and 832 were evaluable at cycle 3 (ipilimumab/HDI = 267 [32.1%]; pembrolizumab = 565 [67.9%]). Evaluable patients were predominantly younger than 65 years (623 [74.9%]) and male (779 [58.9%]). Estimates of FACT-BRM TOI cycle 3 compliance did not differ by arm (ipilimumab/HDI, 96.0% vs pembrolizumab, 98.3%; P = .25). The adjusted cycle 3 FACT-BRM TOI score was 9.6 points (95% CI, 7.9-11.3; P < .001) higher (better QOL) for pembrolizumab compared with ipilimumab/HDI, exceeding the prespecified clinically meaningful difference. In linear-mixed models, differences by arm exceeded 5 points in favor of pembrolizumab through cycle 7. In post hoc analyses, FACT-BRM TOI scores favored the pembrolizumab arm compared with the subset of patients receiving ipilimumab (difference, 6.0 points; 95% CI, 4.1-7.8; P < .001) or HDI (difference, 17.0 points; 95% CI, 14.6-19.4; P < .001).

CONCLUSIONS AND RELEVANCE: This secondary analysis of a phase 3 randomized clinical trial found that adjuvant pembrolizumab improved QOL vs treatment with adjuvant ipilimumab or HDI in patients with high-risk resected melanoma.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02506153.

PMID:36416836 | DOI:10.1001/jamaoncol.2022.5486

JAMA Surg. 2022 Nov 23. doi: 10.1001/jamasurg.2022.5697. Online ahead of print.

ABSTRACT

IMPORTANCE: Long-term oncologic outcomes of robotic surgery remain a hotly debated topic in surgical oncology, but sparse data have been published thus far.

OBJECTIVE: To analyze short- and long-term outcomes of robotic liver resection (RLR) for hepatocellular carcinoma (HCC) from Western high-volume centers to assess the safety, reproducibility, and oncologic efficacy of this technique.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study evaluated the outcomes of patients receiving RLR vs open liver resection (OLR) for HCC between 2010 and 2020 in 5 high-volume centers. After 1:1 propensity score matching, a group of patients who underwent RLR was compared with a validation cohort of OLR patients from a high-volume center that did not perform RLR.

MAIN OUTCOMES AND MEASURES: A retrospective analysis was performed of prospectively maintained databases at 2 European and 2 US institutions of patients who underwent RLR for HCC between January 1, 2010, and September 30, 2020. The main outcomes were safety and feasibility of RLR for HCC and its oncologic outcomes compared with a European OLR validation cohort. A 2-sided P < .05 was considered significant.

RESULTS: The study included 398 patients (RLR group: 125 men, 33 women, median [IQR] age, 66 [58-71] years; OLR group: 315 men, 83 women; median [IQR] age, 70 [64-74] years), and 106 RLR patients were compared with 106 OLR patients after propensity score matching. The RLR patients had a significantly longer operative time (median [IQR], 295 [190-370] minutes vs 200 [165-255] minutes, including docking; P < .001) but a significantly shorter hospital length of stay (median [IQR], 4 [3-6] days vs 10 [7-13] days; P < .001) and a lower number of admissions to the intensive care unit (7 [6.6%] vs 21 [19.8%]; P = .002). Incidence of posthepatectomy liver failure was significantly lower in the RLR group (8 [7.5%] vs 30 [28.3%]; P = .001), with no cases of grade C failure. The 90-day overall survival rate was comparable between the 2 groups (RLR, 99.1% [95% CI, 93.5%-99.9%]; OLR, 97.1% [95% CI, 91.3%-99.1%]), as was the cumulative incidence of death related to tumor recurrence (RLR, 8.8% [95% CI, 3.1%-18.3%]; OLR, 10.2% [95% CI, 4.9%-17.7%]).

CONCLUSIONS AND RELEVANCE: This study represents the largest Western experience to date of full RLR for HCC. Compared with OLR, RLR performed in tertiary centers represents a safe treatment strategy for patients with HCC and those with compromised liver function while achieving oncologic efficacy.

PMID:36416833 | DOI:10.1001/jamasurg.2022.5697

JAMA Netw Open. 2022 Nov 1;5(11):e2243597. doi: 10.1001/jamanetworkopen.2022.43597.

ABSTRACT

IMPORTANCE: Use of attention-deficit/hyperactivity disorder (ADHD) medications has increased substantially over the past decades, but there are concerns regarding their cardiovascular safety.

OBJECTIVE: To provide an updated synthesis of evidence on whether ADHD medications are associated with the risk of a broad range of cardiovascular diseases (CVDs).

DATA SOURCES: PubMed, Embase, PsycINFO, and Web of Science up to May 1, 2022.

STUDY SELECTION: Observational studies investigating the association between ADHD medications (including stimulants and nonstimulants) and risk of CVD.

DATA EXTRACTION AND SYNTHESIS: Independent reviewers extracted data and assessed study quality using the Good Research for Comparative Effectiveness (GRACE) checklist. Data were pooled using random-effects models. This study is reported according to the Meta-analyses of Observational Studies in Epidemiology guideline.

MAIN OUTCOMES AND MEASURES: The outcome was any type of cardiovascular event, including hypertension, ischemic heart disease, cerebrovascular disease, heart failure, venous thromboembolism, tachyarrhythmias, and cardiac arrest.

RESULTS: Nineteen studies (with 3 931 532 participants including children, adolescents, and adults; 60.9% male), of which 14 were cohort studies, from 6 countries or regions were included in the meta-analysis. Median follow-up time ranged from 0.25 to 9.5 years (median, 1.5 years). Pooled adjusted relative risk (RR) did not show a statistically significant association between ADHD medication use and any CVD among children and adolescents (RR, 1.18; 95% CI, 0.91-1.53), young or middle-aged adults (RR, 1.04; 95% CI, 0.43-2.48), or older adults (RR, 1.59; 95% CI, 0.62-4.05). No significant associations for stimulants (RR, 1.24; 95% CI, 0.84-1.83) or nonstimulants (RR, 1.22; 95% CI, 0.25-5.97) were observed. For specific cardiovascular outcomes, no statistically significant association was found in relation to cardiac arrest or arrhythmias (RR, 1.60; 95% CI, 0.94-2.72), cerebrovascular diseases (RR, 0.91; 95% CI, 0.72-1.15), or myocardial infarction (RR, 1.06; 95% CI, 0.68-1.65). There was no associations with any CVD in female patients (RR, 1.88; 95% CI, 0.43-8.24) and in those with preexisting CVD (RR, 1.31; 95% CI, 0.80-2.16). Heterogeneity between studies was high and significant except for the analysis on cerebrovascular diseases.

CONCLUSIONS AND RELEVANCE: This meta-analysis suggests no statistically significant association between ADHD medications and the risk of CVD across age groups, although a modest risk increase could not be ruled out, especially for the risk of cardiac arrest or tachyarrhythmias. Further investigation is warranted for the cardiovascular risk in female patients and patients with preexisting CVD as well as long-term risks associated with ADHD medication use.

PMID:36416824 | DOI:10.1001/jamanetworkopen.2022.43597

JAMA Netw Open. 2022 Nov 1;5(11):e2243618. doi: 10.1001/jamanetworkopen.2022.43618.

ABSTRACT

IMPORTANCE: Accruing evidence suggests that gestational hypertensive disorders (GHTD) and gestational diabetes (GD) are each associated with an increased risk of cardiovascular disease (CVD). However, the extent to which the co-occurrence of GHTD and GD is associated with the risk of CVD remains largely unknown.

OBJECTIVE: To estimate the individual and joint associations of GHTD and GD with incident CVD.

DESIGN, SETTING, AND PARTICIPANTS: This population-based cohort study used the Ministry of Health and Long-Term Care of Ontario (Canada) health care administrative databases. All women in Ontario with a GHTD and/or GD diagnosis, and a live-birth singleton delivery between July 1, 2007, and March 31, 2018, were considered for inclusion. Women with pregravid diabetes, hypertension, or cardiovascular disease were excluded. Statistical analysis was performed from November 2021 to September 2022.

EXPOSURES: GD and/or GHTD, defined using diagnosis coding.

MAIN OUTCOMES AND MEASURES: Individual and joint associations of GHTD and GD with incident CVD (including a composite of myocardial infarction, acute coronary syndrome, stroke, coronary artery bypass grafting, percutaneous coronary intervention, or carotid endarterectomy), estimated using Cox regression models, adjusting for relevant cardiometabolic risk factors. The follow-up extended from the index pregnancy until March 31, 2020.

RESULTS: Among 886 295 eligible women (mean [SD] age, 30 [5.6] years; 43 861 [4.9%] with isolated GHTD, 54 061 [6.1%] with isolated GD, and 4975 [0.6%] with GHTD and GD), there were 1999 CVD events over 12 years of follow-up. In the early postpartum phase (first 5 years post partum), there was no association of co-occurrence of GTHD and GD (adjusted hazard ratio [aHR], 1.42, 95% CI, 0.78-2.58) or GD alone (aHR, 0.80; 95% CI, 0.60-1.06) with CVD; there was an association between isolated GTHD and incident CVD compared with no GTHD and no GD (aHR, 1.90; 95% CI, 1.51-2.35). In the late postpartum period (after the initial 5 years post partum), compared with no GD and no GHTD, isolated GHTD (aHR, 1.41, 95% CI, 1.12-1.76) and co-occurrence of GHTD and GD (aHR, 2.43, 95% CI, 1.60-3.67) were each associated with a higher risk of incident CVD. There was no association between isolated GD and incident CVD.

CONCLUSIONS AND RELEVANCE: In this cohort study, GHTD was associated with a high risk of CVD post partum, and the co-occurrence of GD and GHTD was associated with a much greater postpartum CVD risk. These findings suggest that CVD preventive care is particularly needed in the aftermath of combined GD and GHTD.

PMID:36416822 | DOI:10.1001/jamanetworkopen.2022.43618

JAMA Netw Open. 2022 Nov 1;5(11):e2243653. doi: 10.1001/jamanetworkopen.2022.43653.

ABSTRACT

IMPORTANCE: Studies have suggested a rise in opioid- and stimulant-involved overdoses in recent years in North America. This risk may be acute for individuals who have had contact with the criminal justice system, who are particularly vulnerable to overdose risk.

OBJECTIVE: To examine the association of opioid and/or stimulant use disorder diagnoses with overdose (fatal and nonfatal) among people with histories of incarceration.

DESIGN, SETTING, AND PARTICIPANTS: In this cohort study, population-based health and corrections data were retrieved from the British Columbia Provincial Overdose Cohort, which contains a 20% random sample of residents of British Columbia. The analysis included all people in the 20% random sample who had a history of incarceration between January 1, 2010, and December 31, 2014. Outcomes were derived from 5-years of follow-up data (January 1, 2015, to December 31, 2019). Statistical analysis took place from January 2022 to June 2022.

EXPOSURES: Substance use disorder diagnosis type (ie, opioid use disorder, stimulant use disorder, both, or neither), sociodemographic, health, and incarceration characteristics.

MAIN OUTCOMES AND MEASURES: Hazard ratios (HRs) are reported from an Andersen-Gill model for recurrent nonfatal overdose events and from a Fine and Gray competing risk model for fatal overdose events.

RESULTS: The study identified 6816 people (5980 male [87.7%]; 2820 aged <30 years [41.4%]) with histories of incarceration. Of these, 293 (4.3%) had opioid use disorder only, 395 (6.8%) had stimulant use disorder only, and 281 (4.1%) had both diagnoses. During follow-up, 1655 people experienced 4026 overdoses including 3781 (93.9%) nonfatal overdoses, and 245 (6.1%) fatal overdoses. In adjusted analyses, the hazard of both fatal (HR, 2.39; 95% CI, 1.48-3.86) and nonfatal (HR, 2.45; 95% CI, 1.94-3.11) overdose was highest in the group with both opioid and stimulant use disorder diagnoses.

CONCLUSIONS AND RELEVANCE: This cohort study of people with a history of incarceration found an elevated hazard of fatal and nonfatal overdose among people with both opioid and stimulant use disorder diagnoses. This study suggests an urgent need to address the service needs of individuals who have had contact with the criminal justice system and who co-use opioids and stimulants.

PMID:36416821 | DOI:10.1001/jamanetworkopen.2022.43653

Epidemiologia (Basel). 2022 Nov 8;3(4):502-517. doi: 10.3390/epidemiologia3040038.

ABSTRACT

Since the outbreak of COVID-19, vaccination against the virus has been implemented and has progressed among various groups across all ethnicities, genders, and almost all ages in the United States. This study examines the impacts of socioeconomic status and political preference on COVID-19 vaccination in over 443 counties in the southwestern United States. Regression analysis was used to examine the association between a county’s vaccination rate and one’s personal income, employment status, education, race and ethnicity, age, occupation, residential area, and political preference. The results were as follows: First, counties with higher average personal income tend to have a higher vaccination rate (p &lt; 0.001). Second, county-level vaccination is significantly associated with the percentage of Democrat votes (β = 0.242, p &lt; 0.001). Third, race and ethnicity are vaccine-influencing factors. Counties with more Black residents have lower vaccine acceptance (β = -0.419, p &lt; 0.001), while those where more Hispanics or Native Americans reside are more likely to accept vaccines for health protection (β = 0.202, p &lt; 0.001; β = 0.057, p = 0.008, respectively). Lastly, pertaining to the age difference, seniors aged 65 and older show substantial support for vaccination, followed by the median age group (all p &lt; 0.001).

PMID:36416793 | DOI:10.3390/epidemiologia3040038

J Periodontol. 2022 Nov 23. doi: 10.1002/JPER.22-0414. Online ahead of print.

ABSTRACT

BACKGROUND: This study introduced the root plastique technique (RPT), the aim of which is to modify the gingival phenotype of sites with gingival recessions (GRs) associated with Non-Carious Cervical Lesions (NCCLs) prior to surgical treatment.

METHODS: RPT was performed in 22 subjects with 53 RT1 A/B + GRs. Changes in keratinized tissue thickness (KTT), keratinized tissue width (KTW), relative gingival recession (RGR), relative clinical attachment level (RCAL) and probing pocket depth (PPD) were measured at baseline (T0) and 2 months (T1) after the procedure was performed. All analyses were performed by means of hierarchical models.

RESULTS: The study revealed statistically significant changes (p<0.01) in KTT (0.45 ± 0.04 mm), RGR (0.80 ± 0.13mm), KTW (0.67 ± 0.07mm), RCAL (-0.72 ± 0.16mm) and KTW (0.67 ± 0.07). No changes in PPD (p>0.05) were observed. Regression analyses of KTT increase and RGR reduction at T0 showed statistically significant correlation between the 2 variables (p<0.05). All the teeth with a KTT of <0.8mm at T0 (N = 14) reached or surpassed this threshold at T1.

CONCLUSION: RPT increases KTT and KTW. In most of the sites, a reduction in GR was also achieved. This article is protected by copyright. All rights reserved.

PMID:36416786 | DOI:10.1002/JPER.22-0414

J Neuroophthalmol. 2022 Nov 1. doi: 10.1097/WNO.0000000000001734. Online ahead of print.

ABSTRACT

BACKGROUND: Idiopathic intracranial hypertension (IIH) is uncommon in men. Previous studies reported on high frequency of obstructive sleep apnea (OSA) in men with IIH, but the pathophysiology of this association remains unclear. One possible culprit for increased intracranial pressure in patients with OSA is hypercapnia. The purpose of this study was to compare the rate of hypercapnia during polysomnography (PSG) study in men with and without IIH and to report on the rate and severity of OSA in men with IIH compared with control subjects of similar age and body mass index (BMI).

METHODS: Prospective case-control study of male patients diagnosed with IIH underwent PSG with continuous oxygen and carbon dioxide monitoring overnight. Healthy control subjects with similar age and BMI also underwent PSG. The incidence of OSA diagnosis, rate of hypercapnia and hypoxia, and apnea hypopnea index (AHI) were compared between 2 groups.

RESULTS: Eleven subjects with IIH and 10 controls underwent PSG. Both groups were similar regarding age and BMI on the Mann-Whitney U test (P = 0.072 for age, P = 0.251 for BMI). Subjects for whom carbon dioxide data were not available for more than 50% of total sleep time were excluded from hypercapnia analysis. The mean age was 41.9 years, and the mean BMI was 33.8 kg/m2 in subjects and controls. OSA was diagnosed in 9 of 11 men with IIH and 4 of 10 controls. There was no statistically significant difference in the rate of hypercapnia and hypoxia between 2 groups for whom the data were available. All patients with BMI over 30 kg/m2 (7 of 7) and 50% (2 of 4) controls with BMI over 30 kg/m2 were diagnosed with OSA compared with 50% (2 of 4) of cases and 33% (2 of 6) of controls with BMI less than 30 kg/m2. BMI was a significant predictor of total AHI (P = 0.042) and OSA severity (P = 0.023), but IIH diagnosis was not (P > 0.05).

CONCLUSIONS: There was no difference in hypercapnia rate between men with IIH and controls; thus, hypercapnia is an unlikely causative factor in pathophysiology of IIH. OSA on PSG was almost 2 times as prevalent in patients with IIH compared with controls; however, BMI was the strongest predictor of OSA diagnosis, and most patients (9 of 11) with BMI over 30 kg/m2 had OSA on PSG. In men with BMI less than 30, the rate of OSA on PSG study was higher in men with IIH. Based on these data, we recommend that all men with the diagnosis of IIH should undergo PSG study.

PMID:36416758 | DOI:10.1097/WNO.0000000000001734

Chem Commun (Camb). 2022 Nov 23. doi: 10.1039/d2cc05589a. Online ahead of print.

ABSTRACT

We show for the first time glycosylation of recombinant metallothioneins (MTs) produced in E. coli. Interestingly, our results show that the glycosylation level of the recombinant MTs is inversely proportional to the degree of protein structuration, and reflects their different metal preferences.

PMID:36416731 | DOI:10.1039/d2cc05589a