Category: Nevin Manimala

JMIR Hum Factors. 2022 Aug 2. doi: 10.2196/38701. Online ahead of print.

ABSTRACT

BACKGROUND: Over the last few years, increasingly studies focused on the development of mobile apps as complementary tools to existing pharmacovigilance traditional surveillance systems for improving and facilitating adverse drug reactions reporting.

OBJECTIVE: In this study, we evaluated the potentiality of a new mobile app (vaxEffect@UniMiB) to perform longitudinal studies while preserving the anonymity of the respondents. We applied it to monitor the adverse drug reactions during COVID-19 vaccination campaign in a sample of Italian population.

METHODS: We administered vaxEffect@UniMiB to a convenience sample of academic subjects vaccinated at Milano-Bicocca University hub for COVID-19 during the Italian national vaccination campaign. vaxEffect@UniMiB was developed for both Android and iOS devices. The mobile app asks users to send their medical history and, upon every vaccine administration, their vaccination data and the adverse reactions that occurred within seven days after the vaccination, allowing the follow of reactions dynamic for each respondent. The app sends data over the web to an application server. The web server, along with receiving all user data, saves them in a SQL database server, and reminds patients to submit vaccine and adverse reactions’ data by push notifications sent to the mobile app through Firebase Cloud Messaging. On initial startup of the app, a unique user identifier was generated for each respondent, so that its anonymity is completely ensured, while enabling longitudinal studies.

RESULTS: A total of 3712 people have been vaccinated during the first vaccination wave. A total of 2733 respondents between the ages of 19 and 80, coming from the University of Milano-Bicocca and the Politecnico of Milan, participated in the survey. Overall, we collected the information about vaccination and adverse reactions to the first vaccine dose for 2226 subjects (60.0% of vaccinated), to the second dose for 1610 subjects (43.3%), and, in a non-sponsored fashion, to the third dose for 169 individuals.

CONCLUSIONS: vaxEffect@UniMiB revealed to be the first attempt in performing longitudinal studies to monitor the same subject over time in terms of the reported ADRs after each vaccine administration, while guaranteeing at the same time complete anonymity of the subjects. A series of aspects contributed to a positive involvement from people in using this application to report their ADRs to vaccination: ease of use, availability from multiple platforms, anonymity of all the survey participants and protection of the submitted data and the healthcare workers’ support.

PMID:35930561 | DOI:10.2196/38701

PLoS One. 2022 Aug 5;17(8):e0271923. doi: 10.1371/journal.pone.0271923. eCollection 2022.

ABSTRACT

CONTEXT: Multimorbidity is highly prevalent among older adults and associated with a high mortality. Prediction of mortality in multimorbid people would be clinically useful but there is no mortality risk index designed for this population. Our objective was therefore to develop and internally validate a 1-year mortality prognostic index for older multimorbid adults.

METHODS: We analysed data of the OPERAM cohort study in Bern, Switzerland, including 822 adults aged 70 years or more with multimorbidity (3 or more chronic medical conditions) and polypharmacy (use of 5 drugs or more for >30 days). Time to all-cause mortality was assessed up to 1 year of follow-up. We performed a parametric Weibull regression model with backward stepwise selection to identify mortality risk predictors. The model was internally validated and optimism corrected using bootstrapping techniques. We derived a point-based risk score from the regression coefficients. Calibration and discrimination were assessed by the calibration slope and C statistic.

RESULTS: 805 participants were included in the analysis. During 1-year of follow-up, 158 participants (20%) had died. Age, Charlson-Comorbidity-Index, number of drugs, body mass index, number of hospitalizations, Barthel-Index (functional impairment), and nursing home residency were predictors of 1-year mortality in a multivariable model. Using these variables, the 1-year probability of dying could be predicted with an optimism-corrected C statistic of 0.70. The optimism-corrected calibration slope was 0.93. Based on the derived point-based risk score to predict mortality risk, 7% of the patients classified at low-risk of mortality, 19% at moderate-risk, and 37% at high-risk died after one year of follow-up. A simpler mortality score, without the Charlson-Comorbidity-Index and Barthel-Index, showed reduced discriminative power (optimism-corrected C statistic: 0.59) compared to the full score.

CONCLUSION: We developed and internally validated a mortality risk index including for the first-time specific predictors for multimorbid adults. This new 1-year mortality prediction point-based score allowed to classify multimorbid older patients into three categories of increasing risk of mortality. Further validation of the score among various populations of multimorbid patients is needed before its implementation into practice.

PMID:35930547 | DOI:10.1371/journal.pone.0271923

PLoS One. 2022 Aug 5;17(8):e0271172. doi: 10.1371/journal.pone.0271172. eCollection 2022.

ABSTRACT

It is an increasingly accepted idea that biological diversity stabilizes ecosystem processes and the services they provide to society. By reducing biomass fluctuation, biodiversity could mitigate the impact of changing environmental conditions on rural incomes as long as people exploits a diverse set of natural assets. This effect is analogous to the risk-spreading function of financial portfolios. This paper presents evidence of the portfolio effect for an open-access artisanal fishery in an estuarine ecosystem, located in a Colombian Biosphere Reserve. Using catch statistics from 2002 to 2018, we evaluate the contribution of catch diversity to the stabilization of fishing income. We find that changes in catch composition are related to seasonal and interannual variations in salinity conditions. The portfolio effect arises from asynchronous fluctuations of fish species due to fluctuating environmental conditions. Catch diversification, instead of specialization, help achieve resilient fisheries.

PMID:35930546 | DOI:10.1371/journal.pone.0271172

PLoS One. 2022 Aug 5;17(8):e0272278. doi: 10.1371/journal.pone.0272278. eCollection 2022.

ABSTRACT

The burial rates of males and females in early modern central London were compared to investigate a possible bias towards male mortality in the plague years of 1563, 1593, 1603, 1625 and 1665. The burial records of sixteen parishes were examined and compared with the five-year periods immediately preceding each plague year when recorded burials were substantially less. A markedly higher burial rate for males was detected in each plague year but this can be partly attributed to a general preponderance of males in the central London population since there was a similar but lesser bias in non-plague years. In the plague years the difference between the frequency of male and female adult burials appears to have been enhanced by the preferential migration of women of childbearing age out of the city since fewer births were recorded in months when plague was rife. Furthermore, when a sample of households was investigated, husbands were significantly more likely to have been buried than their wives. These findings were largely applicable to the plague years of 1603, 1625 and 1665 but were far less apparent in 1563 and 1593. In general, there were more burials of boys than girls in non-plague years which is the expected consequence of their greater vulnerability to childhood diseases. This difference diminished in plague years so that the burials of girls and boys approached parity at a time when burials of children of both sexes were significantly increased. Possibly, plague did not discriminate between the sexes and this characteristic tended to mask the usual vulnerability of boys.

PMID:35930534 | DOI:10.1371/journal.pone.0272278

PLoS One. 2022 Aug 5;17(8):e0271894. doi: 10.1371/journal.pone.0271894. eCollection 2022.

ABSTRACT

BACKGROUND: The impact of COVID-19 international travel restrictions has to date, not been fully explored, and with the ongoing threat that new variants could potentially restrict movement further, it is important to consider the impacts that travel restrictions have on community members. This study aimed to evaluate the psychological and financial impact of COVID-19 travel restrictions on those separated from their partners or immediate families, as well as temporary visa holders who were unable to migrate.

METHODS: Between 4 November 2021 to 1 December 2021, we executed a cross-sectional online survey targeting three specific groups; (1) those stranded from their partners; (2) those stranded from immediate families; and (3) temporary visa holders unable to migrate or cross international borders. We collected data on respondents’ demographic profile; the nature of COVID-19-related travel impacts; depression, anxiety, and stress levels (using the validated DASS-21); and finally, data on respondents financial, employment and accommodation situation.

RESULTS: 1363 respondents located globally completed the survey. 71.2% reported financial stress, 76.8% ([Formula: see text], SD = 5.94) reported moderate-to-extremely severe depression, 51.6% ([Formula: see text], SD = 5.49) moderate-to-extremely severe anxiety, and 62.6% ([Formula: see text], SD = 5.55) moderate-to-extremely severe stress levels. Statistically significant factors associated with moderate-to-extremely severe depression, anxiety, and stress included being female, chronic illness, and experiencing financial stress. Employment during COVID-19 -specifically essential services workers or unemployed-was associated with higher levels of anxiety and stress, with only essential workers being a predictor of higher stress severity. Factors that provided psychological protection included being older and having children.

CONCLUSION: This study is one of the first to explore the impact COVID-19-related international travel restrictions have had on the financial status and psychological health of affected individuals. It highlights the significant human cost associated with the restrictions and identifies psychologically vulnerable populations. These results will help the design of targeted health and social policy responses.

PMID:35930529 | DOI:10.1371/journal.pone.0271894

PLoS One. 2022 Aug 5;17(8):e0268712. doi: 10.1371/journal.pone.0268712. eCollection 2022.

ABSTRACT

PURPOSE: Available but insufficient evidence shows that changes may occur in the immune system following coronavirus disease 2019 (COVID-19). The present study aimed at evaluating immunological changes in patients with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pneumonia compared with the control group.

METHOD: The present study was performed on 95 patients with COVID-19 (32 severe and 63 moderate cases) and 22 healthy controls. Relationship between immune cells, disease severity and lung involvement was assessed. Binary logistic regression and ROC curve tests were used for statistical analysis.

RESULTS: A significant decrease was observed in CD20+ cell counts of the patients. To differentiate patients from healthy individuals, the cutoff point for the CD4+ cell count was 688 /μL, sensitivity 0.96, and specificity 0.84. An increase in CD4+ cells reduces the odds of severe disease (odds ratio = 0.82, P = 0.047) and death (odds ratio = 0.74, P = 0.029). CD4+ cells play a pivotal role in the severity of lung involvement (P = 0.03). In addition to CD4+ cells, Fc gamma receptor III (FcγRIII) (CD16) also played a significant prognosis (odds ratio = 0.55, P = 0.047). In severe cases, C-reactive protein, Blood urea nitrogen, and Creatine phosphokinase levels, as well as neutrophil counts, were significantly higher than those of moderate ones whereas lymphocyte count in severe cases was lower than that of moderate ones.

CONCLUSION: The number of total T-cells and B-cells in patients with COVID-19 was lower than that of controls; however, their NK cells increased. FcγRIII and CD4+ cells are of great importance due to their association with COVID-19 prognosis.

PMID:35930526 | DOI:10.1371/journal.pone.0268712

Nutr Cancer. 2022 Aug 5:1-9. doi: 10.1080/01635581.2022.2104878. Online ahead of print.

ABSTRACT

Dietary factors show different effects on genetically diverse populations. Scientific research uses gene-environment interaction models to study the effects of dietary factors on genetically diverse populations for lung cancer risk. However, previous study designs have not investigated the degree of type I error inflation and, in some instances, have not corrected for multiple testing. Using a motivating investigation of diet-gene interaction and lung cancer risk, we propose a training and testing strategy and perform real-world simulations to select the appropriate statistical methods to reduce false-positive discoveries. The simulation results show that the unconstrained maximum likelihood (UML) method controls the type I error better than the constrained maximum likelihood (CML). The empirical Bayesian (EB) method can compete with the UML method in achieving statistical power and controlling type I error. We observed a significant interaction between SNP rs7175421 with dietary whole grain in lung cancer prevention, with an effect size (standard error) of -0.312 (0.112) for EB estimate. SNP rs7175421 may interact with dietary whole grains in modulating lung cancer risk. Evaluating statistical methods for gene-diet interaction analysis can help balance the statistical power and type I error.

PMID:35930377 | DOI:10.1080/01635581.2022.2104878

Hum Vaccin Immunother. 2022 Aug 5:2099163. doi: 10.1080/21645515.2022.2099163. Online ahead of print.

NO ABSTRACT

PMID:35930374 | DOI:10.1080/21645515.2022.2099163

Head Neck. 2022 Aug 5. doi: 10.1002/hed.27162. Online ahead of print.

ABSTRACT

BACKGROUND: Survival outcomes in recurrent head and neck squamous cell carcinoma (HNSCC) are poor. This study aimed to compare survival outcomes between salvage surgery and immunotherapy in patients with recurrent advanced HNSCC.

METHODS: Patients with advanced stage (stage III or IV) recurrent HNSCC following treatment with platinum-based chemotherapy were included. Survival was estimated using the Kaplan-Meier method, and Cox regression was used for multivariate logistic regression.

RESULTS: Two-year overall survival after salvage surgery was 68.6% and after immunotherapy patients was 24.6%. Multivariate logistic regression showed that salvage surgery was associated with improved survival without statistical significance (hazard ratio [HR] 0.12, p = 0.25). Subgroup analysis of patients with oral cavity/oropharyngeal cancer noted improved survival with salvage surgery over immunotherapy (HR 0.006, p = 0.01) and decreased survival with neutrophil-to-lymphocyte ratio (NLR) > 5 (HR 6.4, p = 0.02).

CONCLUSION: Our retrospective single-institutional data suggest that resectable advanced stage recurrent HNSCC may have improved survival with salvage surgery in appropriately selected patients, but larger prospective studies are required.

PMID:35930296 | DOI:10.1002/hed.27162

JAMA Netw Open. 2022 Aug 1;5(8):e2225805. doi: 10.1001/jamanetworkopen.2022.25805.

ABSTRACT

IMPORTANCE: Limited access to appropriate specialists and testing may be associated with delayed diagnosis and symptom management for patients with early-onset Alzheimer disease and related dementias (ADRDs).

OBJECTIVES: To examine rural vs urban differences in diagnostic and symptom management service use among patients with early-onset ADRDs.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study was conducted using commercial claims from 2012 to 2017. Included patients were those with early-onset ADRDs aged 40 to 64 years, including new patients, defined as those with no claims of ADRDs for 36 months before the first ADRD diagnosis. The likelihood of receiving diagnostic and symptom management services was estimated, with adjustment for individual-level variables associated with health care use. Data were analyzed from February 2021 to March 2022.

EXPOSURES: Rural residence.

MAIN OUTCOMES AND MEASURES: Among patients with new, early-onset ADRDs, use of psychological assessment and neuropsychological testing performed at the initial diagnosis (index date) or 90 days or less after the index date and use of brain imaging during the 180 days before the index date were collected. Access to different clinicians on the index date or 90 days or less after the index date was also collected, including visits to primary care physicians and nurse practitioners (PCPs) and specialty visits to psychologists, neurologists, and psychiatrists.

RESULTS: Among 71 799 patients with early-onset ADRD (mean [SD] age, 56.34 [6.05] years; 39 231 women [54.64%]), 8430 individuals had new early-onset ADRDs (mean [SD] age, 55.94 [6.30] years; 16 512 women [56.65%]). There were no statistically significant differences between new patients with early-onset ADRDs in rural vs urban areas in the use of psychological assessments, imaging studies, or visits to neurologists or psychiatrists. However, new patients in rural areas were less likely to receive neuropsychological testing (odds ratio [OR], 0.83; 95% CI, 0.70-0.98) or visit a psychologist (OR, 0.72; 95% CI, 0.60-0.85) compared with patients in urban areas. However, new patients in rural areas with early-onset ADRDs were more likely to have only PCP visits for diagnosis and symptom management compared with those in urban areas (OR, 1.40; 95% CI, 1.19-1.66).

CONCLUSIONS AND RELEVANCE: This study found that new patients with early-onset ADRDs in rural areas were less likely to receive neuropsychological testing or visit psychologists but more likely to be diagnosed and treated exclusively by PCPs compared with those in urban areas. These findings suggest that efforts, such as clinician education or teleconsultative guidance to PCPs, may be needed to enhance access to specialist services in rural areas.

PMID:35930281 | DOI:10.1001/jamanetworkopen.2022.25805