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Nevin Manimala Statistics

Use of the TestObs mobile application for the evaluation of therapeutic adherence in chronic hemodialysis patients: Technological monitoring model of treatment adherence and determining factors

Nephrol Ther. 2022 Oct 21:S1769-7255(22)00528-4. doi: 10.1016/j.nephro.2022.07.397. Online ahead of print.

ABSTRACT

INTRODUCTION: Non-adherence behaviors are very common in chronic hemodialysis patients, it is estimated that only one patient out of two complies with medical prescriptions, these behaviors are associated with a higher risk of morbidity and adverse events as well as increased expenses for health systems. The aim of our study was to assess adherence to long-term prescribed medications in chronic hemodialysis patients, using a mobile application named TestObs, as well as to determine the main factors influencing medication adherence.

METHODS: We conducted a prospective descriptive study, between January and June 2019. We developed a mobile application named TestObs, downloadable on playstore for android devices, which assesses with the Girerd questionnaire, the adherence to the main medications taken by chronic hemodialysis patients. We included adult patients, with a duration of dialysis of more than 6 months, all patients who downloaded TestObs, tested their adherence to their medication by answering the questionnaire. We created a web-based platform, where data was collected from the application and then analyzed and tabulated. Regarding the statistical analysis, the normal distribution of the variables was studied by the Kolmogorov-Smirnov test, the analysis of the qualitative variables used the Pearson’s Chi2 and Fisher’s statistical test, the Hosmer Lemeshow test was used to examine the quality of the final logistic regression model.

RESULTS: We collected 90 adult chronic hemodialysis patients, 51 of them (56%) were selected to enter the study. We found good compliance in 46.15% of patients, minor noncompliance in 32.87%, and noncompliance in 20.98%. In multivariate analysis, the factors influencing adherence were the presence of other comorbidities (diabetes and vision problems) and the number of pills per day.

DISCUSSION: In this study, we report treatment adherence problems in 53.85% of patients, our results are close to the data reported in hemodialysis patients in the literature, different factors influence the quality of treatment adherence, in our study poly-medication and the presence of other comorbidities were the statistically significant determinants. The new technology assessment instruments were used in hemodialysis patients and were able to provide real-time monitoring of adherence behaviors.

CONCLUSION: We believe that mobile health technologies hold promise for assessing and improving medication adherence in hemodialysis patients, so we suggest that TestObs represents an accessible and free of charge tool, based on a validated questionnaire, that can allow patients to benefit from new technologies for medical monitoring, and may eventually constitute an interventional program to improve medication adherence; however, this technological tool should not replace traditional therapeutic education; prior targeting of non-adherent patients and an optimal combination of several tools can help improve adherence in these patients.

PMID:36280551 | DOI:10.1016/j.nephro.2022.07.397

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Full thickness skin graft versus split thickness skin graft in paediatric patients with hand burns: Systematic review and meta-analysis

Burns. 2022 Sep 29:S0305-4179(22)00249-2. doi: 10.1016/j.burns.2022.09.010. Online ahead of print.

ABSTRACT

Our objective was to compare the outcomes of full thickness skin grafts versus split thickness skin grafts in paediatric hand burn patients. A systematic review and meta-analysis were carried out in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) Guidelines, and an electronic search was conducted to identify all Randomised Controlled Trials and non-randomised studies comparing the outcomes of full thickness skin grafts versus split thickness skin grafts in paediatric hand burn patients. Primary outcomes included development of post-graft contracture and the necessity for surgical release. Secondary outcomes consisted of evaluation of function, cosmesis and colour, scar and feeling, hair growth, and other complaints. For the analysis, fixed effects modelling was applied. Results: ten non-randomised trials with a total of 532 grafts were found. Full thickness skin grafts exhibited a statistically significant decrease in the development of post-graft contracture (Odds Ratio [OR] = 0.35, P = 0.0001) and later surgical releases (OR = 0.06, P = 0.00001). For secondary outcomes, full thickness skin grafts outperformed split thickness skin grafts in post-operative functional ability. However, split thickness skin grafts, showed to be superior in scar, aesthetic, and colour assessments, and less hair growth was observed for split thickness skin grafts. No significant difference was seen in sensation and donor or recipient site complaints. Overall, full thickness skin grafts are a better alternative for paediatric hand burns than split thickness skin transplants because they are linked with reduced post-graft contracture and the requirement for surgical release.

PMID:36280545 | DOI:10.1016/j.burns.2022.09.010

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Elexacaftor/tezacaftor/ivacaftor and gastrointestinal outcomes in cystic fibrosis: Report of promise-GI

J Cyst Fibros. 2022 Oct 21:S1569-1993(22)01384-4. doi: 10.1016/j.jcf.2022.10.003. Online ahead of print.

ABSTRACT

BACKGROUND: Elexacaftor/tezacaftor/ivacaftor (ETI) improves pulmonary disease in people with cystic fibrosis (PwCF), but its effect on gastrointestinal symptoms, which also affect quality of life, is not clear.

METHODS: PROMISE is a 56-center prospective, observational study of ETI in PwCF >12 years and at least one F508del allele. Gastrointestinal symptoms, evaluated by validated questionnaires: Patient Assessment of Upper Gastrointestinal Disorders-Symptom (PAGI-SYM), Patient Assessment of Constipation-Symptom (PAC-SYM), Patient Assessment of Constipation-Quality of Life (PAC-QOL)), fecal calprotectin, steatocrit and elastase-1 were measured before and 6 months after ETI initiation. Mean difference and 95% confidence intervals were obtained from linear regression with adjustment for age and sex.

RESULTS: 438 participants fully completed at least 1 questionnaire. Mean (SD) for baseline PAGI-SYM, PAC-SYM, and PAC-QOL total scores were 0.56 (0.59), 0.47 (0.45), and 0.69 (0.53) out of maximum 5, 4, and 5, respectively (higher score indicates greater severity). Corresponding age- and sex-adjusted 6 months mean changes (95% CI) in total scores were -0.15 (-0.21, -0.09) for PAGI-SYM, -0.14 (-0.19, -0.09) for PAC-SYM, and -0.15 (-0.21, -0.10) for PAC-QOL. While statistically significant, changes were small and unlikely to be of clinical importance. Fecal calprotectin showed a change (95% CI) from baseline of -66.2 µg/g (-86.1, -46.2) at 6 months, while fecal elastase and steatocrit did not meaningfully change.

CONCLUSIONS: After 6 months of ETI, fecal markers of inflammation decreased. Gastrointestinal symptoms improved, but the effect size was small. Pancreatic insufficiency did not improve.

PMID:36280527 | DOI:10.1016/j.jcf.2022.10.003

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Effects of cost sharing on long-term care service utilization among home-dwelling older adults in Japan

Health Policy. 2022 Oct 6:S0168-8510(22)00271-8. doi: 10.1016/j.healthpol.2022.10.002. Online ahead of print.

ABSTRACT

OBJECTIVES: This study aimed to examine the effect of increased cost sharing on long-term care (LTC) service utilization among home-dwelling older adults, using nationwide long-term care insurance (LTCI) claims data in Japan.

METHODS: In August 2015, the coinsurance rate for Japanese LTCI increased from 10% to 20% for higher-income beneficiaries. We analyzed 27,911,076 person-month observations between April 2015 and July 2016 from 1,983,163 home-dwelling older adults (aged ≥ 65 years). We employed a difference-in-differences approach to estimate the effect of the increased coinsurance rate on overall LTC service utilization and for each of the four main service subcategories. The control group comprised those whose coinsurance rates remained at 10%.

RESULTS: The treatment group, whose coinsurance rate increased, accounted for 9.6% of all participants. The raised coinsurance rate caused statistically significant reductions of 0.46% (95% confidence interval [CI]: 0.36%, 0.56%) and $25.7 (95% CI: $23.7, $27.8) in the percentage of utilization of LTC services and total monthly LTC expenditures per person, respectively. Service utilization decreased in each of the four service subcategories.

CONCLUSIONS: The increased coinsurance rate resulted in statistically significant but small reductions in LTC service utilization overall and in each service type among higher-income home-dwelling beneficiaries. Requiring more cost sharing from higher-income individuals may alleviate the fiscal burden on LTC systems without serious reductions in service utilization.

PMID:36280519 | DOI:10.1016/j.healthpol.2022.10.002

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Excess mortality and protected areas during the COVID-19 pandemic: Evidence from Italian municipalities

Health Policy. 2022 Oct 13:S0168-8510(22)00276-7. doi: 10.1016/j.healthpol.2022.10.005. Online ahead of print.

ABSTRACT

There is widespread debate on the drivers of heterogeneity of adverse COVID-19 pandemic outcomes and, more specifically, on the role played by context-specific factors. We contribute to this literature by testing the role of environmental factors as measured by environmentally protected areas. We test our research hypothesis by showing that the difference between the number of daily deaths per 1,000 inhabitants in 2020 and the 2018-19 average during the pandemic period is significantly lower in Italian municipalities located in environmentally protected areas such as national parks, regional parks, or Environmentally Protected Zones. After controlling for fixed effects and various concurring factors, municipalities with higher share of environmentally protected areas show significantly lower mortality during the pandemic than municipalities that do not benefit from such environmental amenities.

PMID:36280518 | DOI:10.1016/j.healthpol.2022.10.005

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Early functional analysis on the pulmonary hemodynamic effects of Transamniotic Stem Cell Therapy (TRASCET) in the nitrofen model of congenital diaphragmatic hernia

J Pediatr Surg. 2022 Sep 26:S0022-3468(22)00610-8. doi: 10.1016/j.jpedsurg.2022.09.022. Online ahead of print.

ABSTRACT

PURPOSE: Transamniotic stem cell therapy (TRASCET) with mesenchymal stem cells (MSCs) has been shown to impact pulmonary vascular development and remodeling in experimental congenital diaphragmatic hernia (CDH), with secondary structural cardiac effects. We sought to determine whether TRASCET has any functional impact on term fetal pulmonary hemodynamics in the nitrofen model.

METHODS: Time-dated pregnant rat dams (n = 13) received nitrofen on gestational day 9 (E9) to induce fetal CDH. Fetuses (n = 155) were divided into three groups: untreated (n = 45), and two groups receiving volume-matched intra-amniotic injections on E17 of either saline (sham; n = 46), or a suspension of amniotic fluid-derived MSCs (afMSCs) (TRASCET; n = 64). Donor afMSCs were syngeneic, phenotyped by flow cytometry, and “primed” by exposure to interferon-gamma and interleukin-1beta prior to administration in vivo. At term (E21), fetuses underwent Doppler flow assessment at the mid-pulmonary artery and 4-chamber echocardiogram. Pulmonary vascular resistance was estimated by pulmonary artery acceleration time (PAAT), max velocity (MaxV) and velocity time integral (VTI). Cardiac function was assessed by global longitudinal strain (GLS) and ejection fraction (EF) using speckle analyses. Healthy fetuses (n = 11) served as additional controls. Statistical analysis was by the Mann-Whitney U test RESULTS: High resolution ultrasound data could be obtained from 8 to 13 fetuses per group. The PAAT and the PAAT normalized to cardiac cycle time were significantly improved by TRASCET compared to both untreated and sham-treated CDH (p = 0.004 to <0.001 in all pairwise comparisons). The flow profile sharpness (MaxV:VTI) was increased in untreated (p = 0.06) and sham (p = 0.01) groups but normalized by TRASCET (p<0.01). There was no difference in GLS between TRASCET and either the untreated or sham groups (p = 0.25 to p = 0.93).

CONCLUSION: Transamniotic stem cell therapy improves pulmonary vascular resistance in early term fetuses in the Nitrofen model of congenital diaphragmatic hernia. Further focus on the functional pulmonary hemodynamic impact of this therapy is justified.

LEVEL OF EVIDENCE: N/A (animal and laboratory study).

PMID:36280468 | DOI:10.1016/j.jpedsurg.2022.09.022

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Diversity and demographics of APSA members: Understanding our identity

J Pediatr Surg. 2022 Sep 26:S0022-3468(22)00628-5. doi: 10.1016/j.jpedsurg.2022.09.035. Online ahead of print.

ABSTRACT

INTRODUCTION: There are existing healthcare disparities in pediatric surgery today. Identity and racial incongruity between patients and providers contribute to systemic healthcare inequities and negatively impacts health outcomes of minoritized populations. Understanding the current demographics of the American Pediatric Surgical Association and therefore the cognitive diversity represented will help inform how best to strategically build the organization to optimize disparity solutions and improve patient care.

METHODS: 1558 APSA members were sent an anonymous electronic survey. Comparative data was collected from the US Census Bureau and the Association of American Medical Colleges. Results were analyzed using standard statistical tests.

RESULTS: Of 423 respondents (response rate 27%), the race and ethnicity composition were 68% non Hispanic White, 12% Asian American and Pacific Islander, 6% Hispanic, 5% multiracial, and 4% Black/African American. Respondents were 35% women, 63% men, and 1% transgender, androgyne, or uncertain. Distribution of sexual identity was 97% heterosexual and 3% LGBTQIA. Religious identity was 50% Christian, 22% Agnostic/Atheist, 11% Jewish, 3% Hindu, and 2% Muslim. 32% of respondents were first-generation Americans. Twenty-four different primary languages were spoken, and 46% of respondents were conversational in a second language. These findings differ in meaningful ways from the overall American population and from the population of matriculants in American medical schools.

CONCLUSION: There are substantial differences in the racial, gender, and sexual identity composition of APSA members compared with the overall population in the United States. To achieve excellence in patient care and innovate solutions to existing disparities, representation, particularly in leadership is essential.

TYPE OF STUDY: Survey; original research.

LEVEL OF EVIDENCE: Level IV.

PMID:36280465 | DOI:10.1016/j.jpedsurg.2022.09.035

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Nevin Manimala Statistics

A misadventure of the correlation coefficient

Trends Neurosci. 2022 Oct 21:S0166-2236(22)00188-6. doi: 10.1016/j.tins.2022.09.009. Online ahead of print.

ABSTRACT

The correlation coefficient gauges linear association between two variables. However, interpreting its value depends on the question at hand. This article argues that relying on the correlation coefficient may be irrelevant for many neuroscience research tasks. When the experimental dataset is contextually suitable for binning-averaging, other indicators of statistical association could prove more suitable.

PMID:36280457 | DOI:10.1016/j.tins.2022.09.009

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Prostate-specific Membrane Antigen Positron Emission Tomography/Computed Tomography-based Lymph Node Atlas for Salvage Radiotherapy in Patients with Recurrent Prostate Cancer: A Validation of the New NRG Oncology 2020 guideline

Eur Urol Oncol. 2022 Oct 21:S2588-9311(22)00170-5. doi: 10.1016/j.euo.2022.09.006. Online ahead of print.

ABSTRACT

BACKGROUND: Approximately 20-40% of patients with prostate cancer (PC) who undergo radical prostatectomy (RP) experience relapse, with the majority of these cases developing pelvic lymph node (LN) metastases. Taking new data from the prostate-specific membrane antigen (PSMA) positron emission tomography (PET) era into account, the Radiation Therapy Oncology Group (RTOG) 2009 contouring guideline for the pelvic LNs from 2009 was updated by the NRG Oncology group in 2020 (NRG 2020).

OBJECTIVE: To evaluate and validate the updated NRG 2020 guideline with our established LN atlas.

DESIGN, SETTING, AND PARTICIPANTS: We screened 1653 PSMA PET/computed tomography (CT) data sets for patients with biochemical relapse who underwent a PET scan between November 2012 and November 2017. After screening, we developed an LN atlas using data from 233 patients.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We evaluated LN overlap (OL) with the RTOG 2009 and NRG 2020 contouring guidelines. OL was defined as within (>90%), partly within (10-90%), or outside (<10%).

RESULTS AND LIMITATIONS: In comparison to the RTOG 2009 guideline, 403 (52%), 134 (17%), and 241 (31%) of the LNs were not, were partly, or were fully covered within the overall group, respectively. By contrast, using the NRG 2020 guideline, 302 (39%), 190 (24%), and 286 (37%) of the LNs were not, were partly, or were fully covered, respectively (p < 0.001). Limitations include the retrospective design with missing data and no histopathological confirmation of the PET results.

CONCLUSIONS: The updated NRG 2020 contouring guideline improves coverage of the pelvic LNs in patients undergoing salvage radiation therapy. However, PET/CT should be considered whenever possible to ensure coverage of untypical LN spread.

PATIENT SUMMARY: We compared the 2009 and 2020 guidelines on the radiation area for the pelvis for patients with recurrent prostate cancer that has spread to lymph nodes. The newer guideline provides better coverage of pelvic lymph nodes than the older one and is useful in planning radiation therapy. However, a scan of the pelvis using the newest technique should be considered for individual patients to ensure coverage of untypical lymph nodes.

PMID:36280446 | DOI:10.1016/j.euo.2022.09.006

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Magnetic Resonance Imaging-based T-staging to Predict Biochemical Recurrence after Radical Prostatectomy: A Step Towards the iTNM Classification

Eur Urol Oncol. 2022 Oct 21:S2588-9311(22)00169-9. doi: 10.1016/j.euo.2022.09.005. Online ahead of print.

ABSTRACT

BACKGROUND: Local staging of prostate cancer (PCa) still relies on digital rectal examination (DRE), which therefore remains the standard for risk stratification in guideline recommendations, clinical trials, and patient counseling. This issue is increasingly controversial as multiparametric magnetic resonance imaging (mpMRI) has become the most influential diagnostic tool for local staging of PCa over the past two decades.

OBJECTIVE: To compare various models of T category based on DRE or mpMRI to predict early biochemical recurrence (BCR) after radical prostatectomy (RP).

DESIGN, SETTING, AND PARTICIPANTS: A retrospective multicenter cohort study was conducted between 2014 and 2021. A total of 1436 patients were recruited across eight referral centers in France, Italy, Switzerland, and Belgium.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: BCR was defined as two prostate-specific antigen values of ≥0.2 ng/ml during follow-up. Harrell’s concordance index (C index) was used to compare the discrimination of four models of T staging based on DRE (model 1: cT1 vs cT2 vs cT3) or mpMRI (model 2: organ-confined disease vs extracapsular extension [iECE] vs seminal vesicle invasion [iSVI]; model 3: Prostate Imaging-Reporting and Data System [PI-RADS] ≤3 vs PI-RADS 4 vs PI-RADS 5; and model 4: iT2a [PI-RADS ≤3] vs iT2b [PI-RADS 4] vs iT2c [PI-RADS 5 excluding ECE or SVI] vs iT3a [ECE] vs iT3b [SVI]) to predict BCR.

RESULTS AND LIMITATIONS: Overall, 74 (5%), 845 (59%), 482 (34%), and 35 (2%) patients had low-, intermediate-, high-, and very high-risk PCa, respectively, according to the Mazzone risk classification. After median follow-up of 16 mo, 113 patients experienced BCR. Although the new five-group mpMRI-based T classification system (model 4) had the highest prognostic discrimination (C index 0.694) for predicting early BCR on multivariable analysis, there was overlap between the 95% confidence intervals of the models. On sensitivity analysis, the new mpMRI-based T staging still had a higher C index than DRE for predicting BCR when excluding cN1 patients and comparing it with a five-group DRE-based T classification (cT1c vs cT2a vs cT2b vs cT2c vs cT3), but the overlap between the 95% confidence intervals of the models remained. The main limitation is the short follow-up.

CONCLUSIONS: We described an alternative mpMRI-based T staging for prediction of early BCR after RP for PCa. Our results need to be validated externally before they can be applied in clinical practice.

PATIENT SUMMARY: At present, digital rectal examination of the prostate is used to stage prostate cancer. We developed an alternative model for staging that uses information from magnetic resonance imaging (MRI) scans to predict cancer outcomes for men undergoing surgical removal of the prostate.

PMID:36280445 | DOI:10.1016/j.euo.2022.09.005