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Nevin Manimala Statistics

Evaluating the health effect of a Social Housing programme, Minha Casa Minha Vida, using the 100 million Brazilian Cohort: a natural experiment study protocol

BMJ Open. 2021 Mar 1;11(3):e041722. doi: 10.1136/bmjopen-2020-041722.

ABSTRACT

INTRODUCTION: Social housing programmes have been shown to influence health, but their effects on cardiovascular mortality and incidence of infectious diseases, such as leprosy and tuberculosis, are unknown. We will use individual administrative data to evaluate the effect of the Brazilian housing programme Minha Casa Minha Vida (MCMV) on cardiovascular disease (CVD) mortality and incidence of leprosy and tuberculosis.

METHODS AND ANALYSIS: We will link the baseline of the 100 Million Brazilian Cohort (2001-2015), which includes information on socioeconomic and demographic variables, to the MCMV (2009-2015), CVD mortality (2007-2015), leprosy (2007-2015) and tuberculosis (2007-2015) registries. We will define our exposed population as individuals who signed the contract to receive a house from MCMV, and our non-exposed group will be comparable individuals within the cohort who have not signed a contract for a house at that time. We will estimate the effect of MCMV on health outcomes using different propensity score approaches to control for observed confounders. Follow-up time of individuals will begin at the date of exposure ascertainment and will end at the time a specific outcome occurs, date of death or end of follow-up (31 December 2015). In addition, we will conduct stratified analyses by the follow-up time, age group, race/ethnicity, gender and socioeconomic position.

ETHICS AND DISSEMINATION: The study was approved by the ethic committees from Instituto Gonçalo Muniz-Oswaldo Cruz Foundation and University of Glasgow Medical, Veterinary and Life Sciences College. Data analysis will be carried out using an anonymised dataset, accessed by researchers in a secure computational environment according to the Centre for Integration of Data and Health Knowledge procedures. Study findings will be published in high quality peer-reviewed research journals and will also be disseminated to policy makers through stakeholder events and policy briefs.

PMID:33649053 | DOI:10.1136/bmjopen-2020-041722

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Randomized Phase II Trial of Polyphenon E versus Placebo in Patients at High Risk of Recurrent Colonic Neoplasia

Cancer Prev Res (Phila). 2021 Mar 1:canprevres.0598.2020. doi: 10.1158/1940-6207.CAPR-20-0598. Online ahead of print.

ABSTRACT

Polyphenon E (Poly E) is a green tea polyphenol preparation whose most active component is epigallocatechin gallate (EGCG). We studied the cancer preventive efficacy and safety of Poly E in subjects with rectal aberrant crypt foci (ACF) which represent putative precursors of colorectal cancers. Eligible subjects had prior colorectal advanced adenomas or cancers, and had > 5 rectal ACF at a pre-registration chromoendoscopy. Subjects (N=39) were randomized to 6-months of oral Poly E (780 mg EGCG) daily or placebo. Baseline characteristics were similar by treatment arm (all P >0.41); 32 of 39 (82%) subjects completed 6-months of treatment. The primary endpoint was percent reduction in rectal ACF at chromoendoscopy comparing before and after treatment. Among 32 subjects (15 Poly E,17 placebo), percent change in rectal ACF number (baseline vs 6-month) did not differ significantly between study arms (3.7% difference of means; P =0.28); total ACF burden was also similar (-2.3% difference of means; P =0.83). Adenoma recurrence rates at 6-months were similar by arm (P >0.35). Total drug received did not differ significantly by study arm; 31 (79%) subjects received >70% of prescribed Poly E. Poly E was well tolerated and adverse events (AEs) did not differ significantly by arm. One subject on placebo had two grade 3 AEs; one subject had grade 2 hepatic transaminase elevations attributed to treatment. In conclusion, Poly E for 6 months did not significantly reduce rectal ACF number relative to placebo. Poly E was well tolerated and without significant toxicity at the dose studied.

PMID:33648940 | DOI:10.1158/1940-6207.CAPR-20-0598

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Is being a ‘left-behind’ child associated with an increased risk of self-poisoning in adulthood? Findings from a case-control study in Sri Lanka

BMJ Glob Health. 2021 Mar;6(3):e003734. doi: 10.1136/bmjgh-2020-003734.

ABSTRACT

PURPOSE: The long-term consequences of parental emigration on offspring self-harm risk is unknown.

METHODS: We investigated the association between experiencing parental emigration in childhood with hospital presentations for self-poisoning in adulthood using a hospital case-control study. Cases were adult self-poisoning patients (≥18 year olds) admitted to the medical toxicology ward Teaching Hospital Peradeniya, Sri Lanka. Sex and age frequency matched controls were recruited from the outpatient department or nearby specialist clinics at the same hospital. Details of parental emigration were collected using a pre-piloted questionnaire. The relationship between parental emigration and self-poisoning in adulthood was estimated using logistic regression models.

RESULTS: 298 cases, and 500 hospital controls were interviewed for the study. We estimate that one in five adults experienced parental emmigration as children (95% CI 17% to 24%). We find limited evidence that children from households with emigrating parents were more likely to experience adverse childhood experiences than those with non-emigrating parents. We found no statistical evidence of an increased risk of self-poisoning in adulthood in individuals who experienced parental emigration (maternal or paternal) during childhood. There was no statistical evidence that the impact differed by the sex of the participant.

CONCLUSION: Adults who experienced parental emigration as children were no more likely to self-poison than adults with non-emigrating parents. Further research using longitudinal data are needed to understand whether any adverse outcomes observed in ‘left-behind’ children are a consequence of parental emigration or due to factors associated but predate the emigration. Prospective data are also important to investigate whether there are any lasting effects on children who experience parental emigration.

PMID:33648980 | DOI:10.1136/bmjgh-2020-003734

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Neoadjuvant chemotherapy in early-stage cervical cancer (<2 cm) before conization for fertility preservation: is there any advantage over upfront conization?

Int J Gynecol Cancer. 2021 Mar;31(3):379-386. doi: 10.1136/ijgc-2020-001751.

ABSTRACT

BACKGROUND: Neoadjuvant chemotherapy before fertility-sparing surgery is an accepted option for patients with cervical tumors between 2 cm and 4 cm. There is a paucity of data regarding its role in patients with tumors <2 cm. Our objective was to compare the oncological and obstetrical outcomes between patients who underwent neoadjuvant chemotherapy before cervical conization versus upfront cervical conization in patients with cervical cancer with tumors <2 cm.

METHODS: We conducted a systematic literature review and searched MEDLINE, EMBASE, and CINAHL (from 1995 to March 2020) using the terms: uterine cervix neoplasms, cervical cancer, fertility-sparing surgery, fertility preservation, conization, cone biopsy, and neoadjuvant chemotherapy. We included manuscripts with information on patients with tumor size <2 cm, lymph node status, follow-up, oncological and obstetrical outcome, and toxicity related to neoadjuvant chemotherapy. We excluded review articles or articles with duplicated patient information.

RESULTS: We identified 12 articles, including 579 patients. For final analysis, 261 patients met inclusion criteria. The most common histology was non-squamous cell carcinoma (62%). Median follow-up time was 63.5 (range 7-122) months for the neoadjuvant chemotherapy group and 48 (range 12-184) months for the upfront cervical conization group. There was no difference in either overall survival (neoadjuvant chemotherapy group 100% vs upfront cervical conization 99.7%, p=0.79) or disease-free survival (neoadjuvant chemotherapy 100% vs upfront cervical conization 98.9%, p=0.59) between the groups. Fertility preservation rate was 81.4% versus 99.1% (p<0.001) favoring upfront cervical conization. No statistically significant differences were seen in live birth rate or pregnancy loss. Also, we found that all neoadjuvant chemotherapy patients reported chemotherapy-related toxicity (30.7% grade 3 and 69.2% grade 1-2).

CONCLUSIONS: There was no difference in disease-free survival or overall survival between patients who underwent neoadjuvant chemotherapy followed by conization and upfront cervical conization. Patients who underwent upfront cervical conization had a higher fertility preservation rate.

PMID:33649005 | DOI:10.1136/ijgc-2020-001751

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Treatment delay in early-stage oral squamous cell carcinoma and its relation to survival

J Craniomaxillofac Surg. 2021 Feb 12:S1010-5182(21)00053-6. doi: 10.1016/j.jcms.2021.02.007. Online ahead of print.

ABSTRACT

The aim of this study was to investigate the impact of a prolonged treatment delay on survival in patients with primary oral squamous cell carcinoma. The investigators hypothesized that treatment delay affects survival, supposing a poor outcome in patients with prolonged treatment initiation. In addition, a critical treatment delay should be defined. Inclusion criteria were a histopathological diagnosis of primary squamous cell carcinoma of the oral cavity and a surgery-based treatment of the tumor. Patients with a history of previously diagnosed malignancies and patients with distant metastasis at the time of diagnosis were excluded from this protocol. Common clinical and histopathological data were assessed retrospectively. Treatment delay was analyzed for the interval between initial presentation and the date of surgery. A total of 484 patients could be included. Considering early-stage patients, the risk of death increases by 1.8% for each day that the treatment delay is prolonged if all other characteristics do not change (p = 0.0035). In patients with advanced disease, a prolonged treatment delay does not affect the risk of death (p = 0.9134). In terms of progression-free survival, treatment delay tends to be associated with a higher risk of recurrence in early-stage disease, but without being statistically significant (p = 0.0718). For patients with early-stage disease, a treatment delay of 20 days is critical regarding overall survival (p = 0.011). For patients with advanced-stage disease, no significant differences have been observed. As patients with early-stage oral squamous cell carcinoma profit from early treatment initiation, we suggest an acceptable maximum treatment delay of no more than 20 days in the surgical management of these patients.

PMID:33648813 | DOI:10.1016/j.jcms.2021.02.007

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Generalized Anxiety Disorder: A Modifiable Risk Factor for Pain Catastrophizing After Total Joint Arthroplasty

J Arthroplasty. 2021 Feb 12:S0883-5403(21)00162-5. doi: 10.1016/j.arth.2021.02.023. Online ahead of print.

ABSTRACT

BACKGROUND: Patients with mood disorders undergoing total joint arthroplasty (TJA) are at increased risk for poor outcomes. This study seeks to examine the effect of anxiety disorders on pain following TJA and evaluate if anxiety disorders are a modifiable risk factor.

METHODS: Between March 2019 and July 2020, 319 TJA patients had preoperative anxiety screening using the Generalized Anxiety Disorder 2-item screening tool (GAD-2) and 6-week postoperative Pain Catastrophizing Scale scores. Patients were organized into 4 cohorts based on preoperative selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) use and GAD-2 scores: Group 1: no SSRI/SNRI use and GAD-2 score <3 (control patients); Group 2: SSRI/SNRI use and GAD-2 score <3 (appropriately treated GAD patients); Group 3: no SSRI/SNRI use and GAD-2 score ≥3 (untreated GAD patients); and Group 4: SSRI/SNRI use and GAD-2 score ≥3 (poorly treated GAD patients). The cohorts underwent multivariate linear regression analysis and equivalence testing.

RESULTS: Patients with preoperative GAD-2 scores ≥3 had worse postoperative pain with significantly higher average 6-week postoperative Pain Catastrophizing Scale score than patients with GAD-2 scores <3 (9.90 vs 5.19, P < .001). Patients with appropriately treated GAD and the control group had statistically equivalent postoperative pain, while patients with poorly treated or untreated GAD had worse postoperative pain.

CONCLUSION: Preoperative GAD is a risk factor for poor postoperative pain control but is a modifiable risk factor when patients are appropriately treated. Screening for preoperative GAD with GAD-2 and referral for treatment may improve patient outcomes and reduce opioid consumption following TJA.

PMID:33648840 | DOI:10.1016/j.arth.2021.02.023

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Evaluation of treatment response in active tuberculosis using QuantiFERON-TB Gold Plus

Eur Cytokine Netw. 2020 Dec 1;31(4):129-133. doi: 10.1684/ecn.2020.0457.

ABSTRACT

Tuberculosis (TB) is one of the leading infectious causes of death worldwide and despite the progress recently made in TB control at a global level, the decline in its incidence is still slow. It is therefore crucial to evaluate the performance of new tools for monitoring of TB treatment. The aim of this study was to evaluate the response to tuberculosis treatment using the QuantiFERON-TB Gold Plus (QFT-Plus) kit. Blood samples of 100 patients with active TB were taken before treatment and after three months, if treatment was successful and sputum culture was negative. Whole blood was incubated in the presence or absence of the TB antigens, TB1 and TB2-specific antigens, and the production of IFN-γ was determined using the QuantiFERON-TB Gold Plus (QFT-Plus) test. The data were analyzed using SPSS 16 software and statistical significance was assessed at a two-tailed P value of 0.05. The median values of IFN-γ released following stimulation with TB1 peptides decreased slightly after treatment (2.5 IU/mL (IQR: 0.9-5.3), compared to the baseline (3.4 IU/mL (IQR: 0.5-6.6)). Also, with respect to the TB1 antigen, 38 out of 45 patients were positive for the QFT test before treatment (84.4%) and 37 cases after treatment (82.2%). On the other hand, the median values of IFN-γ determined with the TB2 test declined marginally after treatment (2.7 IU/mL; IQR: 0.95-5.8), as compared to pretreatment (3.0 IU/mL; IQR: 0.7-8.9). Thirty-nine out of 45 patients (86.7%) before initiation of treatment and 37 cases following a 3-month treatment (82.2%) were had positive values. Moreover, the median values of IFN-γ of TB2 minus TB1 before and after treatment were 0.17 (IQR: 0-1.0) and 0.03 (IQR: 0.0.48), respectively; however, these differences were not significant (p value=0.29). Conclusion: The results of this study show no significant differences between the IFN-γ release in TB patients prior to and after treatment. However, more extensive studies are needed in different populations with higher sample sizes to validate these results.

PMID:33648920 | DOI:10.1684/ecn.2020.0457

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The spectrum of skin diseases in four different types of organ-transplant recipients: a comparative single-centre cohort study

Eur J Dermatol. 2021 Mar 1. doi: 10.1684/ejd.2021.3967. Online ahead of print.

ABSTRACT

BACKGROUND: Organ transplant recipients (OTR) are at marked increased risk of skin cancer and skin infections compared to the general population.

OBJECTIVES: The purpose of this study was to acquire long-term incidence data on commonly occurring skin diseases in four different transplant groups.

MATERIALS & METHODS: This retrospective single-centre cohort study included 621 OTR. By counting defined malignant, inflammatory, infectious or drug-related skin conditions per patient and visit, incidence rates (IR) for the different groups of OTR were calculated as cases per 1000-patient years and cumulative incidences of non-melanoma skin cancer (NMSC), respectively.

RESULTS: Overall, 2,309 non-malignant skin conditions and 340 NMSC were registered. Skin infections were most common (51.4%), followed by inflammatory skin conditions (35.6%) and sun-induced skin damage (32.9%). Kidney transplant recipients (KTR) had a 4.7-fold (95% CI: 2.7-8.0; p < 0.0001), 2.6-fold (95% CI: 1.2-5.3; p = 0.0098) and 5.4-fold (95% CI: 2.8-10.3; – < 0.0001) higher IR for oral candidiasis, oral aphthosis and herpes simplex virus infections, respectively, compared to the other OTR. Pruritus was most commonly reported in liver transplant recipients (95% CI: 1.3-5.3; p = 0.0047). KTR and lung transplant recipients (LuTR) had a 10.7-fold (95% CI:3.6-43.2; p < 0.0001) higher IR of steroid induced acne. KTR had a 1.6-fold (95% CI: 1.1-2.3; p = 0.0096) higher IR of squamous cell carcinoma compared to the other groups. The incidence of basal cell carcinoma was 2.5-fold higher (95% CI: 1.7-3.6; p < 0.0001) in LuTR, compared to the other OTR.

CONCLUSIONS: This study provides additional organ-specific incidence data on non-malignant skin diseases and skin cancer in OTR.

PMID:33648926 | DOI:10.1684/ejd.2021.3967

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Apolipoprotein E homozygous ε4 allele status: Effects on cortical structure and white matter integrity in a young to mid-age sample

Eur Neuropsychopharmacol. 2021 Feb 26:S0924-977X(21)00135-8. doi: 10.1016/j.euroneuro.2021.02.006. Online ahead of print.

ABSTRACT

Apolipoprotein E (APOE) genotype is the strongest single gene predictor of Alzheimer’s disease (AD) and has been frequently associated with AD-related brain structural alterations before the onset of dementia. While previous research has primarily focused on hippocampal morphometry in relation to APOE, sporadic recent findings have questioned the specificity of the hippocampus and instead suggested more global effects on the brain. With the present study we aimed to investigate associations between homozygous APOE ε4 status and cortical gray matter structure as well as white matter microstructure. In our study, we contrasted n = 31 homozygous APOE ε4 carriers (age=34.47 years, including a subsample of n = 12 subjects with depression) with a demographically matched sample without an ε4 allele (resulting total sample: N = 62). Morphometry analyses included a) Freesurfer based cortical segmentations of thickness and surface area measures and b) tract based spatial statistics of DTI measures. We found pronounced and widespread reductions in cortical surface area of ε4 homozygotes in 57 out of 68 cortical brain regions. In contrast, no differences in cortical thickness were observed. Furthermore, APOE ε4 homozygous carriers showed significantly lower fractional anisotropy in the corpus callosum, the right internal and external capsule, the left corona radiata and the right fornix. The present findings support a global rather than regionally specific effect of homozygous APOE ε4 allele status on cortical surface area and white matter microstructure. Future studies should aim to delineate the clinical implications of these findings.

PMID:33648793 | DOI:10.1016/j.euroneuro.2021.02.006

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Patient attitude and habits regarding removable denture home hygiene and correlation with prosthesis cleanliness: A cross-sectional study of elderly Italians

J Prosthet Dent. 2021 Feb 26:S0022-3913(21)00071-8. doi: 10.1016/j.prosdent.2021.01.024. Online ahead of print.

ABSTRACT

STATEMENT OF PROBLEM: With the aging population, an increasing number of patients will require removable dental prostheses. Despite the recent public efforts to improve oral healthcare, knowledge of hygiene procedures for removable dental prostheses is sparse.

PURPOSE: The purpose of this cross-sectional study was to determine, through questionnaires, the level of awareness and education of home hygiene procedures among elderly Italian individuals wearing removable dental prostheses and to correlate self-reported hygiene habits and prosthesis cleanliness, as determined by a clinical examination.

MATERIAL AND METHODS: A cross-sectional study was performed by questionnaires administered by a dental hygienist to patients attending the dental clinics (prosthodontic and periodontology clinical units) at San Paolo Hospital of Milan from January 2014 to October 2015 and who volunteered to participate. The questionnaire included demographic data and oral hygiene habits. Each participant received an intraoral and prosthesis examination performed by the same dental hygienist. The cleanliness of the removable dental prosthesis was classified according to a 3-point scoring system. Categorical variables were expressed as a percentage of study participants and compared by using the χ2 test, while, for the statistical correlations between continuous and categorical variables, the point-biserial correlation calculator was used (α=.05).

RESULTS: Questionnaires were collected from 161 study participants: 92 women (mean ±standard deviation age: 76 ±7.59 years; range: 65-93 years) and 69 men (mean ±standard deviation age: 74 ±6.31 years; range: 65-86 years). A total of 239 prostheses were considered. A significant correlation was found between older participants, older removable dental prostheses, and reduced prosthesis cleanliness, correlating age ranges of participants as well as of removable dental prostheses with the degrees of prosthesis cleanliness (P=.001 and P=.004, respectively). Half the study participants (n=81; 50.3%) reported prosthesis removal during the night, while the others reported sleeping with the prosthesis in place. Some study participants (n=32; 19.9%) reported that they had never received instructions about how to clean the prosthesis. Mechanical brushing with toothbrush and toothpaste was the most common cleaning method (n=47; 29.2%), while the recommended combined cleaning method based on both mechanical brushing and immersion in dental cleanser was applied by 34 (21.1%) study participants. A similar number (n=25; 15.5%) reported at least 1 episode of denture-related stomatitis.

CONCLUSIONS: In the analyzed cohort, patient attitude and habits toward home procedures for denture hygiene resulted in poor prosthesis cleanliness. Most individuals used a toothbrush and toothpaste to clean their device, although combining mechanical and chemical cleaning is typically reported to be the optimal method.

PMID:33648795 | DOI:10.1016/j.prosdent.2021.01.024