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Conclusions
knee arthroplasty, VTE
In summary, six hours a day may be the optimal duration of applying VFP for the prevention of VTE in patients receiving hip and knee arthroplasty. However, further studies are needed to validate these findings.
PMC10691185
Acknowledgements
TRANSFORMATION
We appreciated the funding support of the Military Medical Transformation Project of PLA General Hospital (ZH19009), the Innovation Project of the National Clinical Research Center for Orthopaedics and Sports Rehabilitation of China (2021-NCRC-CXJJ-ZH-36).
PMC10691185
Authors’ contributions
Conception and design of the study: YG and SG. Data processing and analysis: SG and ML. Interpretation of the results: SG, ML, JL, YC, DK, and YG. Drafting of the article: SG, ML, YC, YG, and DK. Critical revision of the article for important intellectual content: SG, ML, JL, YC, WYL, MZ, HZ, MM, DK, and YG. DK and YG kept the data analyzed in the present study and take full responsibility for the content, integrity, and accuracy of the work reported. All authors approved the final manuscript.
PMC10691185
Funding
TRANSFORMATION
This study was funded by the Military Medical Transformation Project of PLA General Hospital (ZH19009), the Innovation Project of the National Clinical Research Center for Orthopaedics and Sports Rehabilitation of China (2021-NCRC-CXJJ-ZH-36). We declare that the funds, grants, or other support were not used to prepare this manuscript.
PMC10691185
Data Availability
Data and materials are available upon reasonable request with the permission of the corresponding authors.
PMC10691185
Declarations
PMC10691185
Ethics approval and consent to participate
All patients voluntarily participated in the study and written informed consent was obtained from each patient. This study has been approved by the Medical Ethics Committee of Chinese PLA General Hospital (No. 2021-002-01) and the First Affiliated Hospital of Suzhou University (No. 2021053). The study will follow the ethical principles for medical research involving human subjects of the Declaration of Helsinki, All subjects will provide informed consent to participate.
PMC10691185
Consent for publication
Informed consent was obtained from all individual participants included in the study.
PMC10691185
Competing interests
The authors declare that they have no conflict of interest.
PMC10691185
References
PMC10691185
Background
GASTRIC NEUROENDOCRINE CARCINOMA, GASTRIC CANCER
Gastric neuroendocrine carcinoma (GNEC) is a rare histology of gastric cancer. The retrospective study was designed to construct and validate a nomogram for predicting the cancer-specific survival (CSS) of postoperative GNEC patients.
PMC10347809
Methods
REGRESSION
Data for 28 patients from the Hangzhou TCM Hospital were identified as the external validation cohort. A total of 1493 patients were included in the SEER database and randomly assigned to the training group (1045 patients) and internal validation group (448 patients). The nomogram was constructed using the findings of univariate and multivariate Cox regression studies. The model was evaluated by consistency index (C-index), calibration plots, and clinical net benefit. Finally, the effect between the nomogram and AJCC staging system was compared by net reclassification index (NRI) and integrated discrimination improvement (IDI).
PMC10347809
Results
tumor
TUMOR, METASTASIS
Age, gender, grade, T stage, N stage, metastasis, primary site, tumor size, RNE, and chemotherapy were incorporated in the nomogram. The C-indexes were 0.792 and 0.782 in the training and internal verification sets. The 1-, 3-, and 5-year CSS predicted by the nomogram and actual measurements had good agreement in calibration plots. The 1-, 3-, and 5-year NRI were 0.21, 0.29, and 0.37, respectively. The 1-, 3-, and 5-year IDI values were 0.10, 0.12, and 0.13 (P < 0.001), respectively. In 1-, 3-, and 5-year CSS prediction using DCA curves, the nomogram outperformed the AJCC staging system. The nomogram performed well in both the internal and external validation cohorts.
PMC10347809
Conclusion
We developed and validated a nomogram to predict 1-, 3-, and 5-year CSS for GNEC patients after surgical resection. This well-performing model could help doctors enhance the treatment plan.
PMC10347809
Keywords
PMC10347809
Introduction
Gastric cancer, heterogeneous malignancy, tumor, AJCC, Cancer
GASTRIC CANCER, TUMOR, CANCER
Gastric cancer (GC) is a highly heterogeneous malignancy with several pathologies exhibiting markedly varied molecular patterns, tumor behavior, and prognoses [American Joint Committee on Cancer (AJCC) TNM staging system has played an essential role in predicting the prognosis of GNEC [Based on the Surveillance, Epidemiology, and End Results (SEER) database, the study was directed to establish and validate a nomogram with a new risk stratification system for predicting the cancer-specific survival (CSS) of postoperative GNEC patients. The model’s performance was also compared with the AJCC 8th staging system.
PMC10347809
Materials and methods
PMC10347809
Data source and patient selection
ONCOLOGY, DISEASES
The data was retrieved from the SEER database during 2010–2015 and analyzed retrospectively. External validation data was obtained from the Hangzhou TCM Hospital between January 2012 and December 2016. This research was carried out in line with the Helsinki Declaration. Participation in this study did not need written informed consent, as required by national law and institutional norms. The Ethics Committee of the Hangzhou TCM Hospital examined and approved the experiment involving human participants.The third edition of the International Classification of Diseases for Oncology (ICD-O-3) was used to identify cases of GNEC. 8012/3, 8013/3, 8041/3, 8042/3, 8043/3, 8044/3, 8244/3, and 8246/3 were the histological codes. The inclusion criteria were as follows: [ Flow diagram of the selection of eligible GNEC patients
PMC10347809
Clinicopathological variables
tumor, T stage, cardia, AJCC
TUMOR
The following characteristics were extracted from the SEER database: year of diagnosis, gender, age, race, marital status, grade, AJCC stage, T stage, N stage, M stage, primary site, tumor size, regional nodes examined (RNE), surgery, radiation therapy, chemotherapy, survival time and vital status. Patients were categorized according to the primary site (cardia, distal site, middle site, and overlapping/NOS), tumor size (≤ 2 cm, ≤5 cm, and >5 cm), and RNE (0, 1–15, and ≥ 16). The GNEC patients were converted to the 8th edition of the AJCC TNM staging system based on the 7th edition in the SEER database. In the research, CSS was regarded as the endpoint. It was defined as the period from diagnosis to cancer-related mortality.
PMC10347809
Statistical analysis
NRI
REGRESSIONS
All patients were randomized into two groups with a 7:3 ratio. The training group was employed to construct the nomogram, while the internal and external validation groups were applied to validate it. Both univariate and multivariate Cox regressions were performed to calculate the significant parameters (P < 0.05). A predictive nomogram was then established to calculate the 1-, 3-, and 5-year CSS for postoperative GNEC cases.To assess discriminative capabilities, the consistency index (C-index) and the time-dependent area under the curve (AUC) were computed using bootstrapping. The higher value of the C-index and AUC denoted greater predictive ability. The 1-, 3-, and 5-year calibration plots (1,000 bootstrap resamples) were used to compare the predicted CSS with what was actually observed. The ideal prediction was shown to be the 45-degree line.The net benefit for a set of threshold probabilities was calculated using decision curve analysis (DCA), which allowed researchers to test how well the model would function as a clinical decision-making tool. The optimum risk score cutoff value was utilized to create a novel risk stratification approach that divides patients into low-, middle-, and high-risk groups using the X-tile software. To compare the variations in CSS among patients in various risk stratification groups, Kaplan-Meier (KM) curves and log-rank tests were used. The C-index, Net Reclassification Index (NRI), Integrated Discrimination Improvement (IDI), and DCA were used to evaluate the new model’s enhanced predictive potential and effectiveness.All statistical computations and visualizations were done using R software version 4.1.2 (
PMC10347809
Results
PMC10347809
Clinicopathological characteristics
1493 GNEC patients were enrolled and divided into the training group (1045 patients) and the internal validation group (448 patients). The 28 patients from the Hangzhou TCM Hospital who made up the external validation cohort were identified. The demographic and clinical characteristics of the patients from the SEER database were shown in Table  The basic characteristics of GNEC patients in the training and validation group
PMC10347809
Univariate and multivariate cox regression analysis
tumor
REGRESSION, TUMOR, METASTASIS
The univariate Cox regression performed in the training group indicated that age, gender, grade, T stage, N stage, metastasis, primary site, tumor size, RNE, and chemotherapy were significant prognostic parameters for GNEC patients (P < 0.05). The important variables identified by univariate Cox regression were then incorporated in multivariate Cox regression analysis, demonstrating that each of these components was an independent variable (Table  Univariate and multivariate Cox regression analysis of CSS for variable in GNEC patients after surgical resection
PMC10347809
Development and internal validation of the nomogram
NRI
REGRESSION
Finally, ten variables screened by multivariate Cox regression were applied to develop the nomogram for predicting the 1-, 3-, and 5-year CSS in GNEC patients (Fig.  A predictive nomogram for postoperative GNEC patientsThe C-indexes were 0.792 (95% CI: 0.770–0.813) and 0.782 (95% CI: 0.749–0.815), respectively, for the training and internal validation groups. The DCA, calibration, and receiver operating characteristic (ROC) curves were displayed in Figs.  ROC of the nomogram for 1-, 3-, and 5-year CSS prediction. Calibration curves of 1-, 3- and 5-year CSS. Decision curve analysis of 1-, 3- and 5-year CSS. The projected CSS rates at 1-, 3-, and 5-year were highly consistent with the results as shown by the calibration curves (Fig.   C-index analysis. NRI and IDI of the nomogram and AJCC staging criteria alone in CSS prediction for postoperative GNEC patientsThe outcomes provided compelling evidence that the nomogram outperformed the AJCC stage system regarding application value and predictive ability.
PMC10347809
New Risk Stratification
GNEC patients were divided into three risk cohorts based on the examination of the X-tile software: low risk (46.0 < total points < 204.5), middle risk (204.5 < total points < 330.2), and high risk (330.2 < total points < 437.6; Fig.  Cut-off point for risk stratification selected using X-tile KM analyses of postoperative GNEC patients. Compared with the new risk stratification, the stage I and stage II patients couldn’t be well distinguished in the AJCC staging system. The limited ability to discriminate between stage III and stage IV was also presented (Fig. 
PMC10347809
External validation of the nomogram
Based on the patient’s data acquired from our institution, external validation was performed to further verify the model’s effectiveness. The ROC curves demonstrated good prediction performance (1-, 3-, and 5-year AUC were 0.85, 0.86, and 0.94, Fig.  Results of the external validation cohort.
PMC10347809
Discussion
cancer, tumor, irresponsiveness
REGRESSION, CANCER, TUMOR, METASTASIS
Currently, the low incidence rate and high heterogeneity hindered further investigation of GNEC [Based on the univariate and multivariate Cox regression analysis, ten parameters (age, gender, grade, T stage, N stage, metastasis, primary site, tumor size, RNE, and chemotherapy) significantly affecting CSS in postoperative GNEC patients were enrolled in the predictive nomogram. By examining the max points of the integrated parameters in the model, grade and TNM stage were regarded as highly significant variables influencing the prognoses. Previous research had shown how these risk variables and GNEC were related. Hu et al. investigated current GNEC epidemiological trends and developed a nomogram to assess these patients’ prognoses. According to the findings, the survival of GNEC was substantially correlated with grade, T, and N staging [It was reported that GNEC patients presented irresponsiveness to traditional chemotherapy [Currently, the AJCC TNM staging system is the main option for cancer prognosis prediction. However, its application in GNEC patients has recently been called into question [
PMC10347809
Limitation
METASTASES
The current study included various limitations due to the nature of the database, which should be considered when interpreting the results. To begin, because this was a retrospective study, selection bias was unavoidable. Second, the SEER database lacked information on precise data on performance status, comorbidities, varied chemotherapy regimens, treatment for distant metastases, somatostatin analogues, and “neuroendocrine cancer-specific” data. Furthermore, the SEER database’s GNEC classification was not completely the same as the WHO classification. Finally, even though the research was externally validated, the small sample data could only provide limited support for the result. Multicenter data with a larger sample size are required to further evaluate the predictive model.
PMC10347809
Acknowledgements
Not applicable.
PMC10347809
Authors’ contributions
Lou YF designed the study; Song X performed the major statistical analysis and drafted the manuscript. Xie YY collected the data and searched the literature. All authors contributed to the article and approved the final version of the manuscript.
PMC10347809
Funding
Not applicable.
PMC10347809
Data Availability
The datasets created and evaluated during this project are housed in the SEER database (
PMC10347809
Declarations
PMC10347809
Ethics approval and consent to participate
We certified that all methods were carried out in line with the Helsinki Declaration. Because the patient data obtained from the SEER database is publicly accessible, no ethical approval was required. The Hangzhou TCM Hospital’s Ethics Committee evaluated and authorized the experiment involving human subjects. The ethics committee waived informed consent for this retrospective investigation.
PMC10347809
Consent for publication
Not applicable.
PMC10347809
Competing interests
The authors declare no competing interests.
PMC10347809
References
PMC10347809
ABSTRACT
malaria, NL63, OC43, coronavirus disease 2019
CORONAVIRUS DISEASE 2019, SARS-COV-2 INFECTION, MALARIA, FOUNDER, CORONAVIRUS, SEVERE ACUTE RESPIRATORY SYNDROME
The authors declare a conflict of interest. The authors report no competing interests to this work. A.H.K. reports receiving consulting fees from Roche. D.J.S. reports AliquantumRx Founder and Board member with stock options (macrolide for malaria), Hemex Health malaria diagnostics consulting and royalties for malaria diagnostic test control standards to Alere- all outside of submitted work.The impact of preexisting antibodies to the four endemic human coronaviruses (ehCoV) (229E, OC43, NL63, and HKU1) on severe (hospitalization) coronavirus disease 2019 (COVID-19) outcomes has been described in small cohorts. Many studies have measured ehCoV 229E, OC43, NL63, and HKU1 antibody levels weeks after recovery rather than in the first weeks of illness, which is more relevant to early hospitalizations. Antibody levels to the spike protein of the four coronaviruses (229E, OC43, NL63, and HKU1), as well as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), were measured both before and immediately after convalescent or control plasma transfusion in 51 participants who were hospitalized and 250 who were not hospitalized, as well as in 71 convalescent and 50 control plasma donors as a subset from a completed randomized controlled trial. In COVID-19 convalescent plasma donors, the ehCoV spike antibodies were 1.2 to 2 times greater than the control donor unit levels, while donor COVID-19 convalescent plasma (CCP) SARS-CoV-2 spike antibodies were more than 600 times the control plasma units. Plasma transfusion, whether COVID-19 convalescent or control, did not alter the post-transfusion antibody levels for the endemic human coronaviruses (229E, OC43, NL63, and HKU1) in those hospitalized and not hospitalized, despite the 1.2- to 2-fold elevation in donor COVID-19 convalescent plasma. There was no influence of prior antibody levels to 229E, OC43, NL63, and HKU1 or post-transfusion antibody levels on subsequent hospitalization. These data, from a well-controlled prospective randomized clinical trial, add evidence that antibodies to ehCoV do not significantly impact COVID-19 outcomes, despite the apparent back-boosting of some ehCoV after SARS-CoV-2 infection.
PMC9973272
KEYWORDS
PMC9973272
OBSERVATION
OC43, NL63, SARS-CoV-2 RBD, coronavirus disease 2019
CORONAVIRUS DISEASE 2019, MAY, CORONAVIRUS, CORONAVIRUS, HEAT
The influence of preexisting antibodies to the four endemic human coronaviruses (ehCoV) (229E, OC43, NL63, and HKU1) on severe (hospitalization) coronavirus disease 2019 (COVID-19) outcomes has not been fully characterized (The prospective association of severe COVID-19 with elevated ehCoV antibody levels at illness onset has not been investigated (This substudy of a larger trial (Antibodies that bind the spike proteins from 229E, NL63, OC43, HKU1, and SARS-CoV-2 were measured using the Meso Scale Diagnostics (MSD; Rockville, MD) V-PLEX COVID-19 coronavirus panel 3 IgG kit at a dilution of 1:5,000. Plates were read on a Meso QuickPlex SQ 120 instrument, and the arbitrary units (AU) were calculated using the MSD Discovery Workbench software according to the manufacturer’s protocol. For the samples in the spike competition experiment, purified recombinant full-length WA-1 SARS-CoV-2 spike protein (150 μg/mL) (The nonhospitalized subset (Characteristics of substudy participants compared to those in the parent study (In CCP donors, the ehCoV spike antibodies were 1.2 to 2 times greater than the control donor unit levels, while the donor CCP SARS-CoV-2 spike antibodies were more than 600 times the levels of the control units (ehCoV antibody levels in donors and nonhospitalized recipients in the early treatment outpatient CCP study. (A) Coronavirus antibody levels (arbitrary units [AU] per milliliter) shown in donor CCP (red circles; Endogenous human coronavirus (ehCoV) antibody levels in hospitalized participants in the early treatment outpatient CCP study. (A) Antibody levels (AU per milliliter) before and 30 min after transfusion of CCP in participants who were eventually hospitalized (red circles; (A) Coronavirus antibody levels (AU/mL) before and 30 min after transfusion of CCP in participants who were seropositive for SARS-CoV-2 RBD prior to transfusion (The increase in convalescent antibody levels against HKU1 and OC43 seen in this study, both of which are also betacoronaviruses, might be from cross-reactivity with elevated SARS-CoV-2 spike antibodies or induction of ehCoV-specific B cells to generate more ehCoV antibodies. We added purified SARS-CoV-2 spike at 150 μg spike/mL plasma (Competition of antibody signal with recombinant SARS-CoV-2 full-length spike protein: 13 donor units (red, no competition) were preincubated with 150 mcg recombinant WA-1 SARS-CoV-2 spike (Heterogeneity heat maps of antibody levels sorted by 229E indicated similar patterns among those hospitalized to those not hospitalized (Heterogeneity of viral antibody levels at the individual level with arbitrary units per milliliter depicted on log scale. (A) Antibody levels at enrollment (screening) for the 50 participants who were hospitalized, including those who received CCP or control plasma, sorted ascending by measured 229E. (B) Screening antibody levels for the 50 antibody-positive, vaccine-negative participants, including those who received CCP or control plasma, sorted ascending by measured 229E. (C) Screening antibody levels for the 100 antibody-negative, vaccine-negative participants who received control plasma, sorted ascending by measured 229E. (D) Screening antibody levels for the 100 antibody-negative, vaccine-negative participants who received CCP, sorted ascending by measured 229E. Download CCP and control plasma donors segregated by region of donation by the 4 ehCoV. CCP are indicated by red circles and control plasma by blue circles. CCP: Washington DC and Maryland (Individual CCP donors, sorted by date of donation during the collection period of the early treatment trial from 1 May to 30 September, for 229E (A), HKU1 (B), NL63 (C), and OC43 (D), with arbitrary units (AU) shown per milliliter. Download The antibody levels of ehCoV in COVID-19 convalescent plasma were only 2-fold different between the control and convalescent plasma. The volume of distribution of the plasma was 3 to 6 L. The measured fold dilution when transfused into healthy individuals was 25-fold with a 200-mL CCP transfusion (Measurement of the available 17 hospitalized participants in the COVID-19 convalescent plasma arm and the 34 in the control plasma arm indicated no absolute ehCoV antibody level differences between these two groups or with 250 other paired participants. Even combining all 51 hospitalized participants to compare them to the 250 participants not hospitalized at screening before transfusion showed no differences.In this study, the EhCoV antibody levels of those hospitalized and those not hospitalized were not distinguishable during the first week of illness, at which time there exists greatest risk for impact on severe COVID-19 outcome. Thus, it is unlikely that preexisting ehCoV antibodies in plasma have any clinically relevant impact on COVID-19 outcomes.
PMC9973272
Data availability.
OC43, NL63
MAY
The data sets generated during and/or analyzed during the current study are available from the corresponding author upon reasonable request.Individual control plasma, sorted by date of donation during the collection period of the early treatment trial from 1 May to 30 September, for 229E (A), HKU1 (B), NL63 (C), and OC43 (D), with arbitrary units (AU) shown per milliliter. Download Participants randomized to CCP with screening antibodies for ehCoV, sorted by date of enrollment during the collection period of the early treatment trial from 1 May to 30 September, for 229E (A), HKU1 (B), NL63 (C), and OC43 (D), with arbitrary units (AU) shown per milliliter. Download Participants randomized to control plasma with screening antibodies against ehCoV, sorted by date of enrollment during the collection period of the early treatment trial from 1 May to 30 September, for 229E (A), HKU1 (B), NL63 (C), and OC43 (D), with arbitrary units (AU) shown per milliliter. Download
PMC9973272
ACKNOWLEDGMENTS
Cancer, Aaron A.R., S. Allen, malaria, Ascada
INFECTIOUS DISEASES, FOUNDER, ALLERGY, MALARIA, ROTH, PAXTON, ROBINSON, CANCER
A. H. Karaba and D. J. Sullivan had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.S. L. Klein, A. L. Cox, A. H. Karaba, and D. J. Sullivan contributed to the conceptualization and design. All authors contributed to acquisition, analysis, or interpretation of the data. A. H. Karaba and D. J. Sullivan drafted the manuscript; all authors critically revised the manuscript for important intellectual content. A. H. Karaba, T. S. Johnston, and D. J. Sullivan conducted the statistical analysis. D. J. Sullivan obtained funding. A. H. Karaba, T. S. Johnston, E. Beck, O. Laeyendecker, and D. J. Sullivan contributed administrative, technical, or material support. A. H. Karaba and D. J. Sullivan supervised the research.This study was funded principally by the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND), in collaboration with the Defense Health Agency (DHA) (contract number W911QY2090012), with additional support from Bloomberg Philanthropies, State of Maryland, the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID) (3R01AI152078-01S1, K08AI156021, U54CA260491, and R01AI138897), the NIH National Cancer Institute (NCI) (U54CA260491), the NIH National Center for Advancing Translational Sciences (NCATS) (U24TR001609-S3), the Division of Intramural Research NIAID NIH, the Mental Wellness Foundation, the Moriah Fund, Octapharma, the Healthnetwork Foundation, and the Shear Family Foundation. The study sponsors did not contribute to the study design, the collection, analysis, and interpretation of data, or the decision to submit the paper for publication.We report no competing interests to this work. A. H. Karaba reports receiving consulting fees from Roche. D. J. Sullivan reports that he is an AliquantumRx founder and board member with stock options (macrolide for malaria), works for Hemex Health malaria diagnostics consulting, and receives royalties for malaria diagnostic test control standards from Alere—all outside the submitted work.The members of the COVID-10 Serologic Studies Consortium are as follows: Barry R. Meisenberg (Anne Arundel Medical Center), Matthew Abinante (Ascada Research), Kevin Oei (Ascada Research), Yuriko Fukuta (Baylor College of Medicine), Seble Kessaye (MedStar Georgetown University Hospital), Laura L. Hammitt (Johns Hopkins Center for American Indian Health), Catherine G. Sutcliffe (Johns Hopkins Center for American Indian Health), Bryan Lau (Johns Hopkins Bloomberg School of Public Health), Atika Singh (Johns Hopkins Bloomberg School of Public Health), David M. Shade (Johns Hopkins Bloomberg School of Public Health), Stephan Ehrhardt (Johns Hopkins Bloomberg School of Public Health), Sheriza N. Baksh (Johns Hopkins Bloomberg School of Public Health), Andrew Pekosz (Johns Hopkins Bloomberg School of Public Health), Arturo Casadevall (Johns Hopkins Bloomberg School of Public Health), Kelly A Gebo (Johns Hopkins University), Shmuel Shoham (Johns Hopkins University), Evan M. Bloch (Johns Hopkins University), Christi E. Marshall (Johns Hopkins University), Anusha Yarava (Johns Hopkins University), Karen Lane (Johns Hopkins University), Nichol A. McBee (Johns Hopkins University), Amy L. Gawad (Johns Hopkins University), Nicky Karlen (Johns Hopkins University), Daniel E. Ford (Johns Hopkins University), Douglas A. Jabs (Johns Hopkins University), Lawrence J. Appel (Johns Hopkins University), Aaron A.R. Tobian (Johns Hopkins University), Daniel F. Hanley (Johns Hopkins University), Adam C. Levine (Lifespan/Brown University Rhode Island Hospital), Janis E. Blair (Mayo Clinic, Phoenix), Aarthi Shenoy (MedStar Washington Hospital Center), Giselle S. Mosnaim (NorthShore University HealthSystem), Thomas J. Gniadek (NorthShore University HealthSystem), Michael Roth (The Bliss Group), Colin Foster (The Next Practice Group), Judith S. Currier (University of California Los Angeles), Sonya L. Health (University of Alabama at Birmingham), Donald N. Forthal (University of California, Irvine Health), Edward R. Cachay (University of California, San Diego), Elizabeth S. Allen (University of California, San Diego), Moises A. Huaman (University of Cincinnati Medical Center), Jonathan M. Gerber (University of Massachusetts Worcester), Shweta Anjan (University of Miami), Jay S. Raval (University of New Mexico), Martin S. Zand (University of Rochester), Bela Patel (University of Texas Health Science Center at Houston), Emily S. Spivak (University of Utah Health), J. Robinson Singleton (University of Utah Health), Valerie C. Cluzet (Vassar Brothers Medical Center), Daniel Cruser (Vassar Brothers Medical Center), James H. Paxton (Wayne State University), Joann R. Petrini (Western Connecticut Health Network, Danbury Hospital), Patrick B. Broderick (Western Connecticut Health Network, Danbury Hospital), William Rausch (Western Connecticut Health Network, Danbury Hospital), MarieElena Cordisco (Western Connecticut Health Network, Danbury Hospital), Jean Hammel (Western Connecticut Health Network, Norwalk Hospital), Benjamin Greenblatt (Western Connecticut Health Network, Norwalk Hospital).
PMC9973272
REFERENCES
PMC9973272
Objective:
stroke
STROKE
to evaluate the effect of nursing home care interventions on the quality of life in family caregivers of aged stroke survivors.
PMC9886075
Method:
stroke, stroke-related
STROKE
a Randomized Clinical Trial, blinded for outcome evaluation. Forty-eighty family caregivers of aged stroke survivors participated in the study. The Intervention Group received three home visits by nurses one month after hospital discharge to provide stroke-related education (i.e., how to access health services and perform care activities) and emotional support. The Control Group received the usual guidance from the health services. Quality of life was assessed using the World Health Organization Quality of Life Assessment (WHOQOL-BREF) instrument and the Old Module(WHOQOL-OLD) 1 week, 2 months, and 1 year after discharge.
PMC9886075
Results:
the caregivers were mainly women, children, or spouses. The caregivers in the Intervention Group and Control Group did not significantly differ in terms of their Overall Quality of Life at baseline. There was no interaction effect between group allocation and Overall Quality of Life(p=0.625) over time. However, there was an interaction effect for Social Relations(p=0.019) and Autonomy (p=0.004).
PMC9886075
Conclusion:
the intervention exerted a statistically significant effect on the quality of life of family caregivers with respect to social relationships and autonomy.
PMC9886075
Trial registration:
NCT02807012.
PMC9886075
Resumo
PMC9886075
Objetivo:
avaliar o efeito de intervenção educativa domiciliar de enfermagem na qualidade de vida de cuidadores familiares de idosos sobreviventes de acidente vascular cerebral (AVC).
PMC9886075
Método:
alta
Ensaio Clínico Randomizado, cego para avaliação de resultados. Quarenta e oito cuidadores familiares de idosos sobreviventes de AVC participaram do estudo. O Grupo de Intervenção recebeu três visitas domiciliares de enfermeiros, um mês após a alta hospitalar, para fornecer educação relacionada ao AVC (como acessar os serviços de saúde e realizar atividades de cuidado) e apoio emocional. O Grupo Controle recebeu as orientações habituais dos serviços de saúde. A qualidade de vida foi avaliada usando o instrumento Avaliação da Qualidade de Vida da Organização Mundial da Saúde (WHOQOL-BREF) e o Módulo
PMC9886075
Resultados:
os cuidadores eram principalmente mulheres, filhos ou cônjuges. Os cuidadores do Grupo Intervenção e do Grupo Controle não diferiram significativamente em termos de Qualidade de Vida Geral no início do estudo. Não houve efeito de interação entre a alocação do grupo e a Qualidade de Vida Geral (p=0,625) ao longo do tempo. No entanto, houve efeito de interação para Relações Sociais (p=0,019) e Autonomia (p=0,004).
PMC9886075
Conclusão:
a intervenção apresentou efeito estatisticamente significativo na qualidade de vida dos cuidadores familiares no que diz respeito às relações sociais e autonomia.
PMC9886075
Registro do ensaio clínico:
NCT02807012.
PMC9886075
Resumen
PMC9886075
Objetivo:
evaluar el efecto de intervenciones de atención domiciliaria de enfermería sobre la calidad de vida en cuidadores familiares de adultos mayores sobrevivientes de accidentes cerebrovasculares.
PMC9886075
Método:
DEL
Ensayo Clínico Aleatorizado, cegado para la evaluación de los desenlaces. Los participantes del estudio fueron 48cuidadores familiares de adultos mayores sobrevivientes de accidentes cerebrovasculares (ACV). El Grupo Intervención recibió tres visitas domiciliarias a cargo de enfermeros un mes después del alta hospitalaria, en las que se les ofreció instrucción relacionada con ACV (es decir, cómo acceder a los servicios de salud y realizar las actividades inherentes a los cuidados) y apoyo emocional. Al Grupo Control se le brindó la orientación habitual de los servicios de salud. La calidad de vida se evaluó mediante el instrumento
PMC9886075
Resultados:
DEL
en su mayoría, los cuidadores fueron mujeres, hijos o cónyuges. Los cuidadores de los grupos Intervención y Control no presentaron diferencias significativas en términos de su Calidad de Vida general de base. La intervención no ejerció ningún efecto entre la asignación a los grupos y la Calidad de Vida general(p=0,625) con el transcurso del tiempo. Sin embargo, la intervención sí tuvo efecto sobre las Relaciones Sociales (p=0,019) y la Autonomía(p=0,004).
PMC9886075
Conclusión:
la intervención ejerció un efecto estadísticamente significativo sobre la calidad de vida de los cuidadores familiares con respecto a las relaciones sociales y a la autonomía.
PMC9886075
Registro del ensayo:
NCT02807012.
PMC9886075
Descriptors:
PMC9886075
Descritores:
PMC9886075
Descriptores:
PMC9886075
Highlights
(1) Presents effect related to the caregivers’ quality of life (social and autonomy). (2) Educational interventions should be focused on post-discharge care activities. (3) Educational interventions should be focused on the emotional of family caregivers. (4) The findings provide recommendations for nurses and policymakers.
PMC9886075
Introduction
stroke, death, cerebrovascular disease, Stroke
STROKE, CEREBROVASCULAR DISEASE, STROKE
Stroke is one of the main causes of death worldwide and the most prevalent cerebrovascular disease among aged peopleMany family caregivers feel unprepared to care for stroke survivors, as they rarely receive sufficient training from health professionalsQoL is defined as “the individuals’ perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards, and concerns”Researchers in China, England, United States of America, Germany, and Hong Kong have long argued for the merits of, and thus have developed, programs guiding and preparing caregivers, with a view to improving their QoLEducational interventions to support health professionals and managers regarding home care practices are common outside Brazil. Home care services are not yet fully consolidated in the Brazilian health policy and informal caregiving has not yet entered the Brazilian public policy radarThe existing studies are descriptive or verify the association of QoL with the caregivers’ sociodemographic characteristics
PMC9886075
Method
PMC9886075
Design
Stroke
STROKE
An RCT, blinded for outcome evaluation. This study is part of a larger RCT called “Nursing Home Care Intervention Post Stroke” (SHARE), registered in ClinicalTrials.gov(NCT02807012). The protocol of this study was methodologically performed and previously published to ensure replicability
PMC9886075
Setting
stroke, Stroke
STROKE, STROKE
The study participants were family caregivers of aged stroke survivors from the Stroke Special Care Unit (SCU-Stroke) of Porto Alegre is the capital city of the state of Rio Grande do Sul (Brazil) and is considered the second Brazilian capital with the highest number of older adults, representing 14.05% of the population
PMC9886075
Population, eligibility criteria and sampling
stroke, disability
STROKE
This study was conducted with family caregivers of stroke survivors aged 60 years old and over. The stroke survivors included in the study were those with a minimum score of 2 (no significant disability despite the symptoms; able to carry out all usual duties and activities) in The Modified Rankin Scale (mRankin)Sample size in this RCT was estimated based on an RCT showing 10-point improvements in caregivers’ QoL
PMC9886075
Randomization and blinding
Randomization was performed using a list generated by the
PMC9886075
Control Group
DISEASE
During hospitalization and at discharge, the family caregivers received usual care from a multidisciplinary team in SCU-Stroke. Additionally, they underwent follow-up from their respective health service networks, which typically includes general information about the disease and some aspects inherent to care, such as drug administration and nutrition
PMC9886075
Intervention
The IG received usual care and the SHARE intervention, which included three HVs from two trained nurses approximately 14, 21 and 30 days after discharge. The INs engaged in a dialogic process with the family caregivers which, in turn, stimulated reflective thinking and shared answersCaregiver education was provided in observing a recommendation that includes, for example, how to safely prepare food, and adaptive clothing
PMC9886075
Study variables and instruments
stroke, ’
STROKE
The stroke survivor data collected prior to discharge pertained to identification (name, address and contact details), sociodemographic data (age, biological sex, schooling, marital status, family income and professional status) and physical health (type of stroke, comorbidities, mRankin and the FIM scores). The caregiver data included sociodemographic characteristics (age, biological sex, schooling and marital status), health status (health problems and morbidities) and caregiver status (relationship and living arrangements with the stroke survivor, days spent caring for the stroke survivor, previous caregiving experience and type of help received from others). The primary outcome of family caregiver’s QoL was assessed using the World Health Organization Quality of Life-Bref (WHOQOL-BREF) instrument and the WHOQOL-OLD module for caregivers aged at least 60 years old. The stroke survivors’ data (identification, sociodemographic data and physical health) and the caregivers’ data (sociodemographic characteristics, health and caregiver status) were collected using a specific questionnaire prepared for this study.Functional capacity of the stroke survivors was assessed by means of FIM. This is a measure of how physically independent aged stroke survivors areThe 24-item WHOQOL-BREF instrument captures QoL across four domains: physical, psychological, social relationships, and environment
PMC9886075
Data collection
stroke
MAY, STROKE
The data were collected between May 2016 and July 2018. All caregivers were visited at their homes by two research assistants, the same who collected baseline caregiver QoL data using WHOQOL-BREF and adjunct WHOQOL-OLD. The stroke survivors were also assessed using FIM. Afterwards, a nurse, who was a research team member but not an IN, randomly allocated 24 caregivers to the IG and another 24 to the CG.The participants in the IG received three additional HVs, one week apart. All IG and CG participants received HVs from research assistants to collect caregiver QoL data two months (month 2) and one year (year 1) after discharge. All such data were collected from allocation-blinded research assistants.
PMC9886075
Statistical analysis
stroke, ’
STROKE
The analyses were performed with intention to treat (ITT). Regardless of the treatment (if any) they received, all randomized participants were included in the statistical analysis and examined according to the group to which they were originally allocatedThe analyses were conducted using the Statistical Package for the Social Sciences(SPSS), version 21.0. Depending on the measurement level, the Student’s t, Mann-Whitney’s U, Pearson’s Chi-square or Fisher’s Exact tests were used to generate and compare family caregivers’ and stroke survivors’ characteristics at baseline. A Generalized Estimating Equations (GEE) model was then employed to capture the effects of the SHARE intervention on the caregivers’ WHOQOL-BREF and WHOQOL-OLD scores over time. “Over time” comparisons were made 7 days after discharge (baseline) versus 2 months after discharge, and at baseline versus 1 year after discharge. We controlled for remarkably different (p<.15) CG and IG family caregiver characteristics, with these possibly including survivor’s marital status, caregiver-survivor relationships, time living with the survivor, and days spent as a family caregiver.
PMC9886075
Validity and reliability
Death
The Brazilian version of WHOQOL-BREF presented good performance concerning internal consistency (α = 0.91), discriminant validity, criterion validity, concurrent validity and test-retest reliability (correlational coefficient scores above 0.7)The Cronbach’s α coefficients of WHOQOL-BREF in this study at baseline were as follows: Physical Health (α = 0.833), Psychological (α = 0.666), Social Relationships (α = 0.507), Environment (α=0.716), and Overall QoL (α = 0.847). At month 2, the internal consistency reliability coefficients (Cronbach’s α) were as follows: 0.776, 0.598, 0.750, 0.651 and 0.803, respectively. At year 1, these coefficients (Cronbach’s α) were 0.831, 0.809, 0.604, 0.706 and 0.909.Regarding WHOQOL-OLD, the Cronbach’s α coefficients at baseline were the following: Sensory Abilities (α = 0.214), Autonomy (α = 0.558), Past, Present and Future Activities (α = 0.695), Social Participation (α = 0.497), Death and Dying (α = 0.827), Intimacy (α = 0.936) and Overall (α = 0.785). At month 2, they were 0.410, 0.521, 0.389, 0.414, 0.841, 0.832 and 0.681, respectively. At year 1, these coefficients were 0.583, 0.589, 0.475, 0.673, 0.665, 0.803 and 0.763.
PMC9886075
Fidelity of the study
The protocol of this study was documented to guarantee reproducibilityAn application guide, containing instructions on how to administer and score WHOQOL and FIM, was made available to the research assistants. All INs had access to the care protocol developedThe HVs were scheduled with the caregivers by phone according to their availability. To mitigate errors in study data entry, the research assistants independently entered the survey answers into an Excel spreadsheet, with cross-checking for inconsistencies by an IN.
PMC9886075
Ethical considerations
prejudice
The participants signed an Informed Consent Form and with assurance of voluntary participation and anonymity. They would be able to withdraw from the study without prejudice, including access to any public health services. No physical harms were anticipated. The study was approved by the institution’s Research Ethics Committee (#16-0181).
PMC9886075
Results
The RCT diagram according to the Consolidated Standards of Reporting Trials (CONSORT) is shown in
PMC9886075
RCT Diagram According to the Consolidated Standards of Reporting Trials(CONSORT)
stroke, ’
STROKE
The stroke survivors’ sociodemographic characteristics and health conditions are shown in
PMC9886075
Sociodemographic characteristics and health status of the stroke survivors (n=48). PortoAlegre, RS, Brazil, 2018
*CG = Control Group;
PMC9886075
Characteristics of the family caregivers (n=48). Porto Alegre, RS, Brazil, 2018
*CG = Control Group; The effects of the SHARE intervention on the WHOQOL-BREF scores are presented in There were statistically significant changes in the Social Relationships scores over time. The CG caregivers had a significantly lower QoL between baseline and year 1 (The environmental QoL scores among the CG caregivers were generally higher at baseline. At month 2, there was a statistically significant (Baseline analyses of WHOQOL-OLD were undertaken using data from nine CG and six IG caregivers. It is important to mention that, during the intervention, the study had losses of participants: at month 2, one CG and two IG caregivers were no longer able to participate and, at year 1, one IG caregiver withdrew from the study. However, using the LOCF method and ITT, all caregivers from the CG (n=9) and the IG (n=6) were analyzed, regardless of the losses.
PMC9886075
Effects of SHARE on the caregivers’ WHOQOL-BREF scores (n=48). Porto Alegre, RS, Brazil, 2018
*Estimated means ± standard error; The SHARE intervention did significantly affect the caregivers’ WHOQOL-OLD scores(
PMC9886075
Effect of SHARE on the family caregivers’ WHOQOL-OLD scores (n=15). PortoAlegre, RS, Brazil, 2018
*Estimated means ± standard error;
PMC9886075
Discussion
stroke, ’ QoL deficits
STROKE
This RCT study focuses on the effects of a tailored educational intervention among family caregivers of Brazilian aged stroke survivors. One year after the stroke survivors had been discharged from SCU-Stroke, statistically significant differences were observed in the family caregivers’ Quality of Life. Our most poignant finding was that the Social Relationships and Autonomy scores consistently favored caregivers who In a German RCTOthersIn a training program in Portugal called InCARE, the caregivers that received guidance on care activities for three months after discharge through HVs and telephone calls reported borderline statistically significantly higher mental QoL levels (p=.050)Although the SHARE intervention exerted significant positive effects on the Social Relationships in the IG Our findings reinforce the positive effect of providing emotional support for family caregivers related to maintaining their own personal activities, self-care and decision-making. During the HVs with the IG, the INs placed great emphasis on sharing caregiving responsibilities with other family members, paying attention to one’s own physical and mental health, and reserving time for oneself and for leisure activities.Delivery of the SHARE intervention was associated with significant differences in Social Relationships and Autonomy, which favored the IG. In Brazil, transitional care programs need the participation of health professionals, aged people and family caregivers to carry out discharge and care planning for a successful hospital-home transitionCohortThe Brazilian Home Care Policy currently recommends an initial HV within seven to 30 days for patients requiring higher levels of care needs due to, for example, having experienced a strokeAnother proven important aspect of the SHARE intervention lies in the instability of the CG scores in nearly all the WHOQOL-BREF domains. The scores in the CG were higher at baseline and dropped over time, generally presenting higher variability. The scores in the IG, while lower at baseline, were more stable over time. This may have been partly due to the support and guidance provided by SHARE nurses who presumably had a better anticipatory understanding of what caregiving entails for aged stroke survivors. All caregivers in this study were providing support to first-time stroke survivors.This RCT has some limitations. First and foremost, the caregivers were recruited from a single Brazilian region with unique social and economic circumstances. It is unfortunate that we had no socioeconomic data pertaining to household characteristics. The caregivers were also working with health professionals with highly specialized knowledge about stroke survivor care. Only answering “what works” without empirical attention to household characteristics does not shed light on the everyday caregiving context. Our findings cannot be generalized beyond the caregivers included in this study. The quantitative research questions draw the attention to a specific population segment (family caregivers) and to a specific living environment (own home) but cannot aptly speak to diversity in the caregivers’ everyday living circumstancesIn a future study, more inclusive sampling among survivors discharged from non-specialized institutions across multiple geographic regions is warranted. We also most certainly need to interview caregivers about their everyday socioeconomic and environmental constraints.Doing so is likely to shed greater light on our Overall QoL findings, with these favoring the IG in our comparisons between month 2 and year 1 scores. When conducting RCTs, using mixed methods is a means to expand what can be learned from an intervention research study. The participants’ voices need to be heard and their shared experiences need to be drawn upon to better understand effectiveness of the intervention. It is necessary to go beyond answering whether an intervention works, to answering how and under what circumstances the results are achievedIt is also worth noting that the way in which QoL is measured in published intervention studies varies considerably across countries. We lacked points of comparison for changes in the WHOQOL-BREF scores over time. Our somewhat pallid internal consistency coefficients for its Psychological and Social Relationships domains are cases-in-point. Nonetheless, it is our position that what we have learned about the power of educational support to effect positive changes in caregivers’ QoL deficits far outweighs these shortcomings. We hope that the findings of this study spurs researchers on to adopt WHOQOL-BREF in future intervention studies so that all such comparisons can be readily made.
PMC9886075
Conclusion
stroke
STROKE
The SHARE intervention exerted a statistically significant effect on family caregivers’ QoL with respect to their social relationships and autonomy. Interventions to support physical provision of care and QoL are important. Gains in knowledge about stroke survivor care and care delivery alone are not sufficient. The caregivers’ knowledge and QoL should be assessed before aged stroke survivors are discharged. In Brazil, there are no formal long-term support service programs for safeguarding caregivers’ QoL. Caregivers need to return home to adequate support systems so that they have time to care for themselves. Multidisciplinary teams that can work with caregivers in their own homes are necessary. Ideally, such teams would include a broad network of healthcare professionals, family members and friends. Public policies that emphasize the importance of all such support programs are critical.
PMC9886075
References
PMC9886075
Background
depressive, depression, Cambodian-American, diabetes
DIABETES
Refugees have high levels of psychological distress that hamper lifestyle change efforts. We previously reported that community health educator (CHE) diabetes prevention interventions decreased HbA1c and depressive symptoms among Cambodian-American refugees with depression; this paper reports health behavior outcomes of those interventions.
PMC10496245
Methods
depression, depressive symptoms, diabetes
DIABETES
Participants were aged 35–75, Khmer speaking, at risk for diabetes, and met study criteria for likely depression by either a) antidepressant medication and/or b) prolonged elevated depressive symptoms. Participants were randomized to one of three CHE interventions: 1) lifestyle intervention called
PMC10496245
Results
The
PMC10496245
Conclusions
depression
CHEs may improve nutrition and physical activity in refugees with depression but more intensive interventions may be required to impact sleep. Improvements in all three behaviors appear to be associated with HbA1c lowering
PMC10496245
Trial registration
ClinicalTrials.gov identifier NCT02502929.
PMC10496245
Keywords
PMC10496245
Methods
Diabetes
DIABETES
Diabetes Risk Reduction through Eat, Walk, Sleep and Medication Therapy Management (DREAM) was a randomized, controlled trial to compare the efficacy of EWS vs. EWS + MTM vs social services (SS, control condition). Assessments were at baseline, endpoint (12-months) and follow-up (15-months). The study was pre-registered at ClinicalTrials.gov identifier: NCT02502929.Participants randomized to SS were assessed for social service needs such as food and housing assistance and then provided support for any unmet needs over 12 months as needed. Participants assigned to EWS or EWS + MTM received their interventions over the course of 12-months. A post-intervention endpoint assessment was conducted at 12-months. A ‘booster’ EWS session (and MTM session for those assigned to EWS + MTM) occurred between 12- and 15-months. A follow-up assessment was conducted 15 months after baseline.All staff who had direct contact with participants were born in Cambodia, bilingual and bicultural. To minimize bias, lay health workers were divided into two roles. To minimize bias, community health The study was conducted according to the World Medical Association Declaration of Helsinki and approved by the UConn Health institutional review board. Participants signed written informed consent forms in their preferred language (Khmer or English) and provided written HIPAA authorization and a release of information for study staff contact with their healthcare provider.
PMC10496245
Participants
Diabetes, diabetes
DIABETES, SPECIAL EVENT, DIABETES
DREAM recruited through referrals from clinicians and social service agencies; outreach at large cultural gatherings such as Cambodian new year celebrations; posters at local Khmer businesses; holding special events at relevant temples and churches. Inclusion criteria were: 1) aged 35–75; 2) Cambodian or Cambodian-American; 3) Khmer speaking; 4) currently living in Connecticut, Massachusetts, or Rhode Island (northeastern U.S.); 5) lived in Cambodia during the Pol Pot regime (1975–1979); 6) ambulatory; 7) consumed meals by mouth; 8) elevated risk for diabetes according to a modified version of the American Diabetes Association Risk Test [
PMC10496245
Procedures
CHW data collectors conducted assessments in a private setting at a location of the participant’s choice, either in-home or at a clinic or social service agency. The CHWs administered surveys verbally and recorded responses in Remote Electronic Data Capture (REDCap) [
PMC10496245
Randomization
After all components of the baseline assessments were complete (i.e., surveys, anthropometrics and blood pressure, actigraphy, bloodwork), participants were individually randomized using an urn randomization [
PMC10496245
Interventions
Participants who were randomized to EWS or EWS + MTM were assigned to receive 3 individual EWS sessions and 24 group EWS sessions delivered by CHEs. The three individual sessions cover behavioral targets included eating no more than 1 small bowl of (brown) rice per meal, walking at least 30 min per day on 6 days per week, and getting 7–9 h of restful sleep per night. The curriculum addresses the influence of genocide and resilience on health behaviors. After completing individual EWS sessions, participants started 1-h EWS group sessions and were asked to attend over 12 months. Each began with group discussion of traditional Khmer concepts of health. Sessions were conversational and activity based, including relaxation, supervised exercise, and cooking components. Each session included SMART (specific, measurable, achievable, realistic, timely) goal setting. Sessions were held in community settings convenient to the participants (e.g., social service agencies, temples). A full description of interventionists, intervention sessions, and settings has been previously reported [Participants assigned to EWS + MTM attended group EWS sessions with participants in the EWS arm. In addition, they received at least 3 MTM sessions between baseline and post assessment. A booster MTM session was also scheduled between endpoint (12-month) and follow-up (15-month) assessments. MTM followed guidelines of the American Pharmacist Association [Participants who were assigned to SS were assessed for any social service needs including food or housing assistance, referral to a healthcare provider, tax preparation, or citizenship applications and CHEs/CHWs followed up to address the need. For equity, after they completed their follow-up assessment, participants randomized to SS received a single, abbreviated EWS session and results of their lab work, along with results to their healthcare provider.
PMC10496245
Measures
PMC10496245
EAT behaviors
cardiometabolic disease, shakes
We assessed three domains of nutrition behaviors important for cardiometabolic disease. Using community-based, participatory methods we developed a brief food frequency questionnaire that was tailored for the Cambodian American diet. It focused on the most commonly consumed sources of carbohydrate (rice, rice products such as rice porridge, sweetened condensed milk, fruit juices, fruit drinks, fruit shakes (e.g., taro bubble tea), and regular soda). Frequency was assessed using a timeframe of the previous 3 months. Amounts were estimated by participants using empty culturally appropriate bowls, plates, teaspoons, tablespoons and drinking glasses that were standardized for volume. Using a validated computerized food database “ESHA—the Food Processor Nutrition Analysis program” [
PMC10496245