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Spontaneous regression of cervical intraepithelial neoplasia 3 in women with a biopsy-cone interval of greater than 11 weeks

BMC Cancer. 2022 Oct 18;22(1):1072. doi: 10.1186/s12885-022-10179-1.

ABSTRACT

BACKGROUND: Although there is broad consensus that only a subset of CIN3 will progress to cancer, there is currently no surefire way to predict which CIN3 will regress. Understanding the natural history of CIN3 is important, and finding markers for progression or regression could improve treatment strategies. According to the guidelines of the American Society for Colposcopy and Cervical Pathology of 2006, positive CIN3 p16 in women should be managed with excisional treatment (LEEP). For ethical reasons we cannot fail to treat women with CIN3 in order to study their regression capacity so we conducted a retrospective study to evaluate the regression rate of CIN3 diagnosed with a biopsy by studying the histological result of the cone removed by LEEP. We also investigated age, HPV genotypes and biopsy-cone interval distance as possible regression factors.

METHODS: We selected 171 women with a histological diagnosis of positive CIN3 p16 as an entry criterion. All patients underwent LEEP / biopsy. A histological diagnosis of the cone of CIN3 or higher was considered as persistence or progression, the diagnosis of CIN1 or lower was considered as regression of the lesion. We used out a logistic model to study the probability of spontaneous regression of CIN3 as a function of the patient’s age, the time elapsed between the biopsy and the cone (in weeks) and the HPV genotype.

RESULTS: We found that the spontaneous regression rate of CIN3 was 15,8%, which was strongly associated with the biopsy-cone interval > 11 weeks. Genotype 16, the most represented, was present both in cases of regression (77.8%) and in persistence (83.3%). Regarding age, the estimated odds ratio of the probability of observing a regression in women over 25 years of age was 0.0045 times that of women under 25 years of age (CI: 0.00020, 0.036). Neither age nor viral genotype are significant as predictors of regression.

CONCLUSION: To wait at least 11 weeks from the biopsy before subjecting the woman to LEEP could prevent unnecessary LEEP procedures, considering also that from CIN3 to carcinoma it takes years before the neoplastic transformation takes place.

PMID:36253767 | DOI:10.1186/s12885-022-10179-1

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Cognitive and biological effects of citrus phytochemicals in subjective cognitive decline: a 36-week, randomized, placebo-controlled trial

Nutr J. 2022 Oct 17;21(1):64. doi: 10.1186/s12937-022-00817-6.

ABSTRACT

BACKGROUND: Auraptene (AUR) and naringenin (NAR) are citrus-derived phytochemicals that influence several biological mechanisms associated with cognitive decline, including neuronal damage, oxidative stress and inflammation. Clinical evidence of the efficacy of a nutraceutical with the potential to enhance cognitive function in cohorts at risk of cognitive decline would be of great value from a preventive perspective. The primary aim of this study is to determine the cognitive effects of a 36-week treatment with citrus peel extract standardized in levels of AUR and NAR in older adults experiencing subjective cognitive decline (SCD). The secondary aim is to determine the effects of these phytochemicals on blood-based biomarkers indicative of neuronal damage, oxidative stress, and inflammation.

METHODS: Eighty older persons with SCD will be recruited and randomly assigned to receive the active treatment (400 mg of citrus peel extract containing 0.1 mg of AUR and 3 mg of NAR) or the placebo at a 1:1 ratio for 36 weeks. The primary endpoint is a change in the Repeatable Battery for the Assessment of Neuropsychological Status score from baseline to weeks 18 and 36. Other cognitive outcomes will include changes in verbal and nonverbal memory, attention, executive and visuospatial functions. Blood samples will be collected from a consecutive subsample of 60 participants. The secondary endpoint is a change in interleukin-8 levels over the 36-week period. Other biological outcomes include changes in markers of neuronal damage, oxidative stress, and pro- and anti-inflammatory cytokines.

CONCLUSION: This study will evaluate whether an intervention with citrus peel extract standardized in levels of AUR and NAR has cognitive and biological effects in older adults with SCD, facilitating the establishment of nutrition intervention in people at risk of cognitive decline.

TRIAL REGISTRATION: The trial is registered with the United States National Library of Medicine at the National Institutes of Health Registry of Clinical Trials under the code NCT04744922 on February 9th, 2021 ( https://www.

CLINICALTRIALS: gov/ct2/show/NCT04744922 ).

PMID:36253765 | DOI:10.1186/s12937-022-00817-6

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Regional differences and temporal trend analysis of Hepatitis B in Brazil

BMC Public Health. 2022 Oct 17;22(1):1931. doi: 10.1186/s12889-022-14296-1.

ABSTRACT

BACKGROUND: Burden disease related to chronic HBV infection is increasing worldwide. Monitoring Hepatitis B occurrence is difficult due to intrinsic characteristics of the infection, nonetheless analyzing this information improves strategic planning towards reducing the burden related to chronic infection. In this line of thought, this study aims to analyze national and regional epidemiology of Hepatitis B and it’s temporal trends based on Brazilian reported cases.

METHODS: Data obtained from the Brazilian National Notifiable Disease Reporting System (SINAN) from 2007 to 2018 were classified by infection status with an original classification algorithm, had their temporal trends analyzed by Joinpoint regression model and were correlated with gender, age and region.

RESULTS: Of the 487,180 hepatitis B cases notified to SINAN, 97.65% had it infection status correctly classified by the new algorithm. Hepatitis B detection rate, gender and age-distribution were different among Brazilian regions. Overall, detection rates remained stable from 2007 to 2018, achieving their maximal value (56.1 cases per 100,000 inhabitants) in North region. However, there were different temporal trends related to different hepatitis B status and age. Women mean age at notification were always inferior to those of men and the difference was higher in Central-West, North and Northeast regions.

CONCLUSION: Hepatitis B affects heterogeneously different populations throughout Brazilian territory. The differences shown in its temporal trends, regional, gender and age-related distribution helps the planning and evaluation of control measures in Brazil.

PMID:36253757 | DOI:10.1186/s12889-022-14296-1

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Risk factors of in-home unintentional injuries among 0-6-year-old children in Changsha city of China: a cross-sectional survey based on Bronfenbrenner’s ecological system theory

BMC Pediatr. 2022 Oct 17;22(1):598. doi: 10.1186/s12887-022-03661-z.

ABSTRACT

BACKGROUND: In-home unintentional injuries (IUIs) seriously threatened children’s safety. Three factors, including risky behaviors, parental supervision, and home environmental risks, have been identified as major causes for IUIs. Studies considering the interrelations between the three were limited and no relative studies has been carried out among Chinese children. The purpose of this study is to fully explore the influences of behavioral, supervisory and environmental risk factors on IUIs and their associations among Chinese children on the bases of our self-developed scales.

METHODS: Through stratified cluster sampling, a cross-sectional survey was conducted with 798 parents of children aged 0 ~ 6 years in Changsha, China. Social demographics and IUIs history in the past year were collected by self-administered questionnaires. Three IUI-related scales, which had been developed and validated by our team, aimed to measure risks from children behavior, parental supervision and in-home environment. Structural equation models were constructed to analyze the relationship of these factors and their influences on IUIs using SPSS 26.0 and AMOS 22.0.

RESULTS: Seven hundred ninety-eight parents were surveyed in total, and 33.58% of them reported with IUIs history of their children. X2/df, goodness-of-fit index (GFI), adjusted goodness-of-fit index (AGFI) and the root-mean-square error of approximation (RMSEA) for the model of the whole children were 4.832, 0.879, 0.856 and 0.069 respectively, indicating an acceptable level of model fit. Direct influences were discovered between risky behaviors and children’s IUIs. Home environmental risks indirectly exerted impacts on IUIs by the mediating effect of risky behaviors, while the significant effect of parental supervision only existed in children aged 4-6 and girls.

CONCLUSIONS: Risky behaviors played a mediating role in IUIs among children. Supervision and environmental risks affected IUIs indirectly by the exposure to risky behaviors. Parental supervision may not be able to offset the risks posed by the environmental and behavioral factors, so effective IUIs prevention strategies should focus on behavioral and environmental interventions, with appropriate supervision strategies based on the age and sex characteristics of the child.

PMID:36253748 | DOI:10.1186/s12887-022-03661-z

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Exploring the psychological and religious perspectives of cancer patients and their future financial planning: a Q-methodological approach

BMC Palliat Care. 2022 Oct 18;21(1):186. doi: 10.1186/s12904-022-01079-z.

ABSTRACT

BACKGROUND: Cancer patients are often hesitant to talk about their mental health, religious beliefs regarding the disease, and financial issues that drain them physically and psychologically. But there is a need to break this taboo to understand the perceptions and behaviours of the patients. Previous studies identified many psychological factors that are bothering cancer patients. However, it still requires exploring new elements affecting their mental and physical health and introducing new coping strategies to address patients’ concerns.

METHODS: The current study aims to identify cancer patients’ perceived attitudes towards the severity of illness, understand their fears, tend towards religion to overcome the disease, and future financial planning by using a Q-methodological approach. Data were collected in three steps from January-June 2020, and 51 cancer patients participated in the final stage of Q-sorting.

RESULTS: The findings of the study are based on the principal component factor analysis that highlighted three essential factors: (1) feelings, (2) religious beliefs about the acceptance of death, and (3) their future personal and financial planning. Further, the analysis shows that the patients differ in their beliefs, causes and support that they received as a coping mechanism.

CONCLUSION: This study explains cancer patients’ psychological discomfort and physical pain but cannot relate it to co-morbidities. Q methodology allows the contextualization of their thoughts and future planning in different sets, like acceptance of death, combating religion’s help, and sharing experiences through various platforms. This study will help health professionals derive new coping strategies for treating patients and financial managers to design insurance policies that help them to share their financial burdens.

PMID:36253745 | DOI:10.1186/s12904-022-01079-z

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Human papillomavirus vaccinations at recommended ages: How a middle school-based educational and vaccination program increased uptake in the Rio Grande Valley

Hum Vaccin Immunother. 2022 Oct 17:2133315. doi: 10.1080/21645515.2022.2133315. Online ahead of print.

ABSTRACT

Human papillomavirus (HPV) vaccination is recommended for U.S. adolescents at ages 11-12 requiring two or three doses depending on if the vaccine series started before age 15. The objective was to compare HPV vaccination rates among medically underserved, economically disadvantaged, students in rural middle school districts (Rio Grande Valley [RGV], Texas) by age of initiation (≤ age 11 years vs. age 12 years and older). This quasi-experimental study included 1,766 students (884 females; 882 males) who received at least one HPV vaccine dose through our school-based vaccination program between 08/2016-06/2022. Summary statistics were stratified by age at initiation and gender. The overall HPV up-to-date (UTD) rate was 59.7% (95% Confidence Interval: 57.4-62.0%). The median age at HPV UTD (range) was 12 years (9-19) and median interval between HPV vaccine doses (range) was 316 days (150-2,855). Most students received the HPV vaccine bundled with other vaccinations (72.4%, 1,279/1,766). There was a higher HPV UTD rate among students who initiated the HPV vaccine on or before age 11 than those who initiated on or after age 12 (73.6% versus 45.1%, respectively). The median age of HPV UTD was age 12 for those initiating on or before 11 years versus age 13 for those initiating on or after 12 years of age. Initiating the HPV vaccine at age ≤11 years increased completion of the HPV vaccine series. Improving HPV vaccine coverage and introduction of pan-gender vaccination programs will significantly decrease HPV-related diseases in the RGV.

PMID:36252275 | DOI:10.1080/21645515.2022.2133315

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Effectiveness of Opioid Analgesic Medicines Prescribed in or at Discharge From Emergency Departments for Musculoskeletal Pain : A Systematic Review and Meta-analysis

Ann Intern Med. 2022 Oct 18. doi: 10.7326/M22-2162. Online ahead of print.

ABSTRACT

BACKGROUND: The comparative benefits and harms of opioids for musculoskeletal pain in the emergency department (ED) are uncertain.

PURPOSE: To evaluate the comparative effectiveness and harms of opioids for musculoskeletal pain in the ED setting.

DATA SOURCES: Electronic databases and registries from inception to 7 February 2022.

STUDY SELECTION: Randomized controlled trials of any opioid analgesic compared with placebo or a nonopioid analgesic administered or prescribed to adults in or on discharge from the ED.

DATA EXTRACTION: Pain and disability were rated on a scale of 0 to 100 and pooled using a random-effects model. Certainty of evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) framework.

DATA SYNTHESIS: Forty-two articles were included (n = 6128). In the ED, opioids were statistically but not clinically more effective in reducing pain in the short term (about 2 hours) than placebo and paracetamol (acetaminophen) but were not clinically or statistically more effective than nonsteroidal anti-inflammatory drugs (NSAIDs) or local or systemic anesthetics. Opioids may carry higher risk for harms than placebo, paracetamol, or NSAIDs, although evidence is very uncertain. There was no evidence of difference in harms associated with local or systemic anesthetics.

LIMITATIONS: Low or very low GRADE ratings for some outcomes, unexplained heterogeneity, and little information on long-term outcomes.

CONCLUSION: The risk-benefit balance of opioids versus placebo, paracetamol, NSAIDs, and local or systemic anesthetics is uncertain. Opioids may have equivalent pain outcomes compared with NSAIDs, but evidence on comparisons of harms is very uncertain and heterogeneous. Although factors such as route of administration or dosage may explain some heterogeneity, more work is needed to identify which subgroups will have a more favorable benefit-risk balance for one analgesic over another. Longer-term pain management once dose thresholds are reached is also uncertain.

PRIMARY FUNDING SOURCE: None. (PROSPERO: CRD42021275293).

PMID:36252245 | DOI:10.7326/M22-2162

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Characteristics, utilization, and concentration of outpatient care for dual-eligible Medicare beneficiaries

Am J Manag Care. 2022 Oct 1;28(10):e370-e377. doi: 10.37765/ajmc.2022.89189.

ABSTRACT

OBJECTIVES: To characterize the (1) distribution of outpatient care for dual-eligible Medicare beneficiaries (“duals”) and (2) intensity of outpatient care utilization of duals vs non-dual-eligible beneficiaries (“nonduals”).

STUDY DESIGN: Using data preceding the introduction of several outpatient alternative payment models, as well as Medicaid expansion, we evaluated the distribution of outpatient care across physician practices using a Lorenz curve and compared utilization of different outpatient services between duals and nonduals.

METHODS: We defined practices that did (high dual) and did not (low dual and no dual) account for the large majority of visits based on the Lorenz curve and then performed descriptive statistics between these groups of practices. Practice-level outcomes included patient demographics, practice characteristics, and county measures of structural disadvantage and population health. Patient-level outcomes included number of outpatient visits and unique outpatient physicians, primary vs subspecialty care visits, and expenditures.

RESULTS: Nearly 80% of outpatient visits for duals were provided by 35% of practices. Compared with low-dual and no-dual practices, high-dual practices served more patients (1117.6 patients per high-dual practice vs 683.8 patients per low-dual practice and 447.5 patients per no-dual practice; P < .001) with more comorbidities (3.9 mean total Elixhauser comorbidities among patients served by high-dual practices vs 3.6 among low-dual practices and 3.3 among no-dual practices; P < .001). With regard to utilization, duals had 2 fewer outpatient visits per year compared with nonduals (13.3 vs 15.2; P < .001), with particularly fewer subspecialty care visits (6.5 vs 7.9; P < .001) despite having more comorbidities (3.5 vs 2.7; P < .001).

CONCLUSIONS: Outpatient care for duals was concentrated among a small number of practices. Despite having more chronic conditions, duals had fewer outpatient visits. Duals and the practices that serve them may benefit from targeted policies to promote access and improve outcomes.

PMID:36252177 | DOI:10.37765/ajmc.2022.89189

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Impact of diabetes mellitus on periprocedural and 18-month clinical outcomes in Korean patients requiring rotational atherectomy: results from the ROCK Registry

Ann Saudi Med. 2022 Sep-Oct;42(5):291-298. doi: 10.5144/0256-4947.2022.291. Epub 2022 Oct 6.

ABSTRACT

BACKGROUND: Diabetes mellitus (diabetes) increases the risk of severe coronary artery calcification, which increases the complexity of percutaneous coronary intervention requiring rotational atherectomy (RA) by interfering with lesion preparation, and limiting final stent expansion.

OBJECTIVE: Investigate 30-day and 18-month clinical outcomes in patients with and without diabetes treated with percutaneous coronary intervention requiring RA.

DESIGN: Medical record review SETTING: Multicenter registry in South Korea PATIENTS AND METHODS: The ROtational atherectomy in Calcified lesions in Korea (ROCK) registry was a large, retrospective, multicenter study to assess RA treatment of severe coronary artery calcification.

MAIN OUTCOME MEASURES: The primary endpoint was target-vessel failure including cardiac death, target-vessel myocardial infarction, and target-vessel revascularization.

SAMPLE SIZE: 540 patients followed for a median of 16.1 months.

RESULTS: Of the 540 patients, 305 had diabetes (56.5%). The diabetes group had a significantly higher frequency of multivessel disease; comorbidities such as hypertension, dyslipidemia, and chronic kidney disease; and lower ejection fraction of the left ventricle compared to the non-diabetes group (n=235). There were no significant differences in procedure success and complications observed between the two groups. Target vessel failure at 30 days between the diabetes and non-diabetes groups was not statistically significant in a multivariate Cox regression analysis (1.6% vs. 2.6%, adjusted hazard ratio [HR] 0.595, 95% confidence interval [CI] 0.154-2.300, P=.451). During an 18-month follow-up, the risk of target vessel failure was higher (12.5% vs. 8.9%) but the difference was not statistically significant (adjusted HR 1.393, 95% CI 0.782-2.482, P=.260).

CONCLUSIONS: Patients with diabetes have a risk of complications comparable to patients without diabetes, and 30-day and 18-month clinical outcomes are similar in severe coronary artery calcification requiring RA, despite having more comorbidities.

LIMITATIONS: Retrospective design. Sample size not based on power calculation.

CONFLICT OF INTEREST: None.

PMID:36252142 | DOI:10.5144/0256-4947.2022.291

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Blood Pressure and Cardiorenal Outcomes With Finerenone in Chronic Kidney Disease in Type 2 Diabetes

Hypertension. 2022 Oct 12. doi: 10.1161/HYPERTENSIONAHA.122.19744. Online ahead of print.

ABSTRACT

BACKGROUND: Chronic kidney disease is frequently associated with hypertension and poorly controlled blood pressure can lead to chronic kidney disease progression. Finerenone, a nonsteroidal mineralocorticoid receptor antagonist, significantly improves cardiorenal outcomes in patients with chronic kidney disease and type 2 diabetes. This analysis explored the relationship between office systolic blood pressure (SBP) and cardiorenal outcomes with finerenone in FIDELIO-DKD trial (Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease).

METHODS: Patients with type 2 diabetes, urine albumin-to-creatinine ratio 30 to 5000 mg/g, and estimated glomerular filtration rate of 25 to <75 mL/min per 1.73 m2 receiving optimized renin-angiotensin system blockade, were randomized to finerenone or placebo. For this analysis, patients (N=5669) were grouped by baseline office SBP quartiles.

RESULTS: Finerenone reduced office SBP across the baseline office SBP quartiles, including patients with baseline office SBP of >148 mm Hg. Overall, patients with lower baseline office SBP quartile and greater declines from baseline in SBP were associated with better cardiorenal outcomes. The risk of primary kidney and key secondary cardiovascular composite outcomes was consistently reduced with finerenone versus placebo irrespective of baseline office SBP quartiles (P value for interaction 0.87 and 0.78, respectively). A time-varying analysis revealed that 13.8% and 12.6% of the treatment effect with finerenone was attributed to the change in office SBP for the primary kidney composite outcome and the key secondary cardiovascular outcome, respectively.

CONCLUSIONS: In FIDELIO-DKD, cardiorenal outcomes improved with finerenone irrespective of baseline office SBP. Reductions in office SBP accounted for a small proportion of the treatment effect on cardiorenal outcomes.

REGISTRATION: URL: https://www.

CLINICALTRIALS: gov; Unique identifier: NCT02540993.

PMID:36252131 | DOI:10.1161/HYPERTENSIONAHA.122.19744