Sociodemographic factors associated with vaccine hesitancy in the South Asian community in Canada.

OBJECTIVE: South Asians represent the largest non-white ethnic group in Canada and were disproportionately impacted by the COVID-19 pandemic. We sought to determine the factors associated with vaccine hesitancy in South Asian Canadians. METHODS: We conducted a cross-sectional analysis of vaccine hesitancy using data collected at the baseline assessment of a prospective cohort study, COVID CommUNITY South Asian. Participants (18 + years) were recruited from the Greater Toronto and Hamilton Area in Ontario (ON) and the Greater Vancouver Area in British Columbia (BC) between April and November 2021. Demographic characteristics and vaccine attitudes measured by the Vaccine Attitudes Examination (VAX) scale were collected. Each item is scored on a 6-point Likert scale, and higher scores reflect greater hesitancy. A multivariable linear mixed effects model was used to identify sociodemographic factors associated with vaccine hesitancy, adjusting for multiple covariates. RESULTS: A total of 1496 self-identified South Asians (52% female) were analyzed (mean age = 38.5 years; standard deviation (SD): 15.3). The mean VAX score was 3.2, SD: 0.8 [range: 1.0‒6.0]. Factors associated with vaccine hesitancy included: time since immigration (p = 0.04), previous COVID-19 infection (p < 0.001), marital status (p < 0.001), living in a multigenerational household (p = 0.03), age (p = 0.02), education (p < 0.001), and employment status (p = 0.001). CONCLUSION: Among South Asians living in ON and BC, time since immigration, prior COVID-19 infection, marital status, living in a multigenerational household, age, education, and employment status were associated with vaccine hesitancy. This information can be used to address vaccine hesitancy in the South Asian population in future COVID-19 waves or pandemics.

RéSUMé: OBJECTIF: Les Asiatiques du Sud, qui représentent le plus grand groupe ethnique non-blanc au Canada, ont été démesurément touchés par la pandémie de COVID-19. Nous avons cherché à déterminer les facteurs associés à l'hésitation vaccinale chez les Canadiennes et les Canadiens asiatiques du Sud. MéTHODE: Nous avons mené une analyse transversale de l'hésitation vaccinale à l'aide des données collectées durant l'évaluation préliminaire d'une étude de cohorte prospective du nom de COVID CommUNITY South Asian. Les personnes participantes (18 ans et plus) ont été recrutées dans la région du grand Toronto et de Hamilton, en Ontario, et dans la région du Grand Vancouver, en Colombie-Britannique, entre avril et novembre 2021. Le profil démographique et les attitudes face aux vaccins, mesurées selon l'échelle Vaccine Attitudes Examination (VAX), ont été obtenus. Chaque élément a été noté selon une échelle de Likert en 6 points (plus la note est élevée, plus l'hésitation vaccinale est importante). Un modèle linéaire multivarié à effets mixtes a servi à identifier les facteurs sociodémographiques associés à l'hésitation vaccinale, en rajustant les données pour tenir compte de plusieurs covariables. RéSULTATS: En tout, 1 496 personnes s'identifiant comme étant Asiatiques du Sud (dont 52 % de femmes) ont été analysées (âge moyen = 38,5 ans; écart-type [S] : 15,3). La note VAX moyenne était de 3,2, S : 0,8 [intervalle : 1,0‒6,0]. Les facteurs associés à l'hésitation vaccinale étaient : le temps écoulé depuis l'immigration (p = 0,04), une infection antérieure par la COVID-19 (p < 0,001), l'état matrimonial (p < 0,001), le fait de vivre dans un ménage multigénérationnel (p = 0,03), l'âge (p = 0,02), l'instruction (p < 0,001) et la situation d'emploi (p = 0,001). CONCLUSION: Chez les Asiatiques du Sud vivant en Ontario et en Colombie-Britannique, le temps écoulé depuis l'immigration, une infection antérieure par la COVID-19, l'état matrimonial, le fait de vivre dans un ménage multigénérationnel, l'âge, l'instruction et la situation d'emploi étaient associés à l'hésitation vaccinale. Ces informations peuvent être utilisées pour aborder l'hésitation vaccinale dans la population asiatique du Sud lors de vagues de COVID-19 ou de pandémies futures.

Confirmatory validation of the patient health questionnaire - 4 (PHQ-4) for gastrointestinal disorders: A large-scale cross-sectional survey.

OBJECTIVE: Using the large Rome Foundation Global Epidemiology Survey dataset, the aim of this study was to evaluate the construct and convergent validity and internal consistency of the PHQ-4 across both gastrointestinal and non-gastrointestinal condition cohorts. Another aim was to provide descriptive information about the PHQ-4 including means, confidence intervals and percentage of caseness using a large representative sample. METHODS: A cross-sectional survey was conducted in 26 countries. Confirmatory factor and internal consistency analyses were conducted across subsamples of patients with gastrointestinal conditions (i.e., disorders of gut-brain interaction [DGBI; any DGBI, individual DGBI, and DGBI region], gastroesophageal reflux disease (GERD), coeliac disease, diverticulitis, inflammatory bowel disease (IBD), cancer anywhere in the gastrointestinal tract, peptic ulcer) and those without a gastrointestinal condition. Convergent validity was also assessed via a series of Pearson's correlation coefficients with PROMIS (physical and mental quality of life), and PHQ-12 (somatisation). RESULTS: Based on 54,127 participants (50.9% male; mean age 44.34 years) confirmatory factor analysis indicated acceptable to excellent model fits for the PHQ-4 across all subsamples and individual DGBI and DGBI region (Comparative Fit Index >0.950, Tucker-Lewis Index >0.950, Root Mean Squared Error of Approximation <0.05, and Standardised Root Mean Square Residual <0.05). The PHQ-4 was found to demonstrate convergent validity (Pearson's correlation coefficients >±0.4), and good internal consistency (Cronbach's α > 0.75). CONCLUSIONS: This study provides evidence that the PHQ-4 is a valid and reliable tool for assessing mental health symptomology in both gastrointestinal and non-gastrointestinal cohorts.

Topical Versus Intravenous Tranexamic Acid in Patients Undergoing Cardiac Surgery: The DEPOSITION Randomized Controlled Trial.

BACKGROUND: Although intravenous tranexamic acid is used in cardiac surgery to reduce bleeding and transfusion, topical tranexamic acid results in lower plasma concentrations compared to intravenous tranexamic acid, which may lower the risk of seizures. We aimed to determine whether topical tranexamic acid reduces the risk of in-hospital seizure without increasing the risk of transfusion among cardiac surgery patients. METHODS: We conducted a multicenter, double dummy, blinded, randomized controlled trial of patients recruited by convenience sampling in academic hospitals undergoing cardiac surgery with cardiopulmonary bypass. Between September 17, 2019, and November 28, 2023, a total of 3242 patients from 16 hospitals in 6 countries were randomly assigned (1:1 ratio) to receive either intravenous tranexamic acid (control) through surgery or topical tranexamic acid (treatment) at the end of surgery. The primary outcome was seizure, and the secondary outcome was red blood cell transfusion. After the last planned interim analysis-when 75% of anticipated participants had completed follow up-the Data and Safety Monitoring Board recommended to terminate the trial, and upon unblinding, the Operations Committee stopped the trial for safety. RESULTS: Among 3242 randomized patients (mean age, 66.0 years; 77.7% male), in-hospital seizure occurred in 4 of 1624 patients (0.2%) in the topical group and in 11 of 1628 patients (0.7%) in the intravenous group (absolute risk difference, -0.5%; 95% CI, -0.9 to 0.03; P = .07). Red blood cell transfusion occurred in 570 patients (35.1%) in the topical group and in 433 (26.8%) in the intravenous group (absolute risk difference, 8.3%; 95% CI, 5.2 to 11.5; P = .007). The absolute risk difference in transfusion of ≥4 units of red blood cells in the topical group compared to the intravenous group was 8.2% (95% CI, 3.4 to 12.9). CONCLUSIONS: Among patients having cardiac surgery, topical administration of tranexamic acid resulted in an 8.3% absolute increase in transfusion without reducing the incidence of seizure, compared to intravenous tranexamic acid.

Early-life external exposome in children 2-5 years old in Colombia.

Exposome studies are advancing in high-income countries to understand how multiple environmental exposures impact health. However, there is a significant research gap in low- and middle-income and tropical countries. We aimed to describe the spatiotemporal variation of the external exposome, its correlation structure between and within exposure groups, and its dimensionality. A one-year follow-up cohort study of 506 children under 5 in two cities in Colombia was conducted to evaluate asthma, acute respiratory infections, and DNA damage. We examined 48 environmental exposures during pregnancy and 168 during childhood in eight exposure groups, including atmospheric pollutants, natural spaces, meteorology, built environment, traffic, indoor exposure, and socioeconomic capital. The exposome was estimated using geographic information systems, remote sensing, spatiotemporal modeling, and questionnaires. The median age of children at study entry was 3.7 years (interquartile range: 2.9-4.3). Air pollution and natural spaces exposure decreased from pregnancy to childhood, while socioeconomic capital increased. The highest median correlations within exposure groups were observed in meteorology (r = 0.85), traffic (r = 0.83), and atmospheric pollutants (r = 0.64). Important correlations between variables from different exposure groups were found, such as atmospheric pollutants and meteorology (r = 0.76), natural spaces (r = -0.34), and the built environment (r = 0.53). Twenty principal components explained 70%, and 57 explained 95% of the total variance in the childhood exposome. Our findings show that there is an important spatiotemporal variation in the exposome of children under 5. This is the first characterization of the external exposome in urban areas of Latin America and highlights its complexity, but also the need to better characterize and understand the exposome in order to optimize its analysis and applications in local interventions aimed at improving the health conditions and well-being of the child population and contributing to environmental health decision-making.

Modeling Zero-inflated Count Data Using Generalized Poisson and Ordinal Logistic Regression Models in Medical Research.

Objectives: In medical research, the study's design and statistical methods are pivotal, as they guide interpretation and conclusion. Selecting appropriate statistical models hinges on the distribution of the outcome measure. Count data, frequently used in medical research, often exhibit over-dispersion or zero inflation. Occasionally, count data are considered ordinal (with a maximum outcome value of 5), and this calls for the application of ordinal regression models. Various models exist for analyzing over-dispersed data such as negative binomial, generalized Poisson (GP), and ordinal regression model. This study aims to examine whether the GP model is a superior alternative to the ordinal logistic regression (OLR) model, specifically in the context of zero-inflated Poisson models using both simulated and real-time data. Methods: Simulated data were generated with varied estimates of regression coefficients, sample sizes, and various proportions of zeros. The GP and OLR models were compared using fit statistics. Additionally, comparisons were made using real-time datasets. Results: The simulated results consistently revealed lower bias and mean squared error values in the GP model compared to the OLR model. The same trend was observed in real-time datasets, with the GP model consistently demonstrating lower standard errors. Except when the sample size was 1000 and the proportions of zeros were 30% and 40%, the Bayesian information criterion consistently favored the GP model over the OLR model. Conclusions: This study establishes that the proposed GP model offers a more advantageous alternative to the OLR model. Moreover, the GP model facilitates easier modeling and interpretation when compared to the OLR model.

Bleeding Risk Prediction in Patients Treated with Antithrombotic Drugs According to the Anatomic Site of Bleeding, Indication for Treatment, and Time Since Treatment Initiation.

Background Reasons for the relatively poor performance of bleeding prediction models are not well understood but may relate to differences in predictors for various anatomical sites of bleeding. Methods We pooled individual participant data from four randomized controlled trials of antithrombotic therapy in patients with coronary and peripheral artery diseases, embolic stroke of undetermined source (ESUS), or atrial fibrillation. We examined discrimination and calibration of models for any major bleeding, major gastrointestinal (GI) bleeding, and intracranial hemorrhage (ICH), according to the time since initiation of antithrombotic therapy, and indication for antithrombotic therapy. Results Of 57,813 patients included, 1,948 (3.37%) experienced major bleeding, including 717 (1.24%) major GI bleeding and 274 (0.47%) ICH. The model derived to predict major bleeding at 1 year from any site (c-index, 0.69, 95% confidence interval [CI], 0.68-0.71) performed similarly when applied to predict major GI bleeding (0.71, 0.69-0.74), but less well to predict ICH (0.64, 0.61-0.69). Models derived to predict GI bleeding (0.75, 0.74-0.78) and ICH (0.72, 0.70-0.79) performed better than the general major bleeding model. Discrimination declined over time since the initiation of antithrombotic treatment, stabilizing at approximately 2 years for any major bleeding and major GI bleeding and 1 year for ICH. Discrimination was best for the model predicting ICH in the ESUS population (0.82, 0.78-0.92) and worst for the model predicting any major bleeding in the coronary and peripheral artery disease population (0.66, 0.65-0.69). Conclusion Performance of risk prediction models for major bleeding is affected by site of bleeding, time since initiation of antithrombotic therapy, and indication for antithrombotic therapy.

Worldwide population prevalence and impact of sub-diagnostic gastrointestinal symptoms.

BACKGROUND: The Rome Foundation Global Epidemiology Study (RFGES) found that 40.3% of adults in 26 internet-surveyed countries met Rome IV criteria for disorders of gut-brain interaction (DGBI). However, additional people not meeting DGBI criteria may also be burdened by frequent gastrointestinal symptoms. AIMS: To explore the prevalence and demographic distribution of sub-diagnostic gastrointestinal symptoms, and the hypothesised associated effects on quality of life (QoL), life functioning and healthcare needs. METHODS: We analysed data from the RFGES survey, which included the Rome IV diagnostic questionnaire and QoL, psychological, work productivity and healthcare questions. RESULTS: Of the 50,033 people without a history of organic gastrointestinal disorders, 25.3% classified in the sub-diagnostic group (no DGBI but one or more frequent gastrointestinal symptoms), 41.4% had DGBI and 33.4% had no frequent gastrointestinal symptoms (non-GI group). Sub-diagnostic prevalence in different world regions ranged from 22.2% (North America) to 30.5% (Middle East), was slightly higher among males than females and decreased with age. The sub-diagnostic group was intermediate between the non-GI and DGBI groups, and significantly different from both of them on QoL, anxiety, depression, somatisation, healthcare utilisation and life and work impairment. CONCLUSIONS: One in four adults without organic gastrointestinal disorders or DGBI report frequent gastrointestinal symptoms. This sub-diagnostic group has reduced QoL, greater psychological and non-GI bodily symptoms, impaired work productivity and life activities and greater healthcare use compared to non-GI individuals. This suggests that many in this sub-diagnostic group might benefit from healthcare services or symptom self-management advice.

Association of glycaemic index and glycaemic load with type 2 diabetes, cardiovascular disease, cancer, and all-cause mortality: a meta-analysis of mega cohorts of more than 100 000 participants.

BACKGROUND: There is debate over whether the glycaemic index of foods relates to chronic disease. We aimed to assess the associations between glycaemic index (GI) and glycaemic load (GL) and type 2 diabetes, cardiovascular disease, diabetes-related cancers, and all-cause mortality. METHODS: We did a meta-analysis of large cohorts (≥100 000 participants) identified from the Richard Doll Consortium. We searched the Cochrane Library, MEDLINE, PubMed, Embase, Web of Science, and Scopus for cohorts that prospectively examined associations between GI or GL and chronic disease outcomes published from database inception to Aug 4, 2023. Full-article review and extraction of summary estimates data were conducted by three independent reviewers. Primary outcomes were incident type 2 diabetes, total cardiovascular disease (including mortality), diabetes-related cancers (ie, bladder, breast, colorectal, endometrial, hepatic, pancreatic, and non-Hodgkin lymphoma), and all-cause mortality. We assessed comparisons between the lowest and highest quantiles of GI and GL, adjusting for dietary factors, and pooling their most adjusted relative risk (RR) estimates using a fixed-effects model. We also assessed associations between diets high in fibre and whole grains and the four main outcomes. The study protocol is registered with PROSPERO, CRD42023394689. FINDINGS: From ten prospective large cohorts (six from the USA, one from Europe, two from Asia, and one international), we identified a total of 48 studies reporting associations between GI or GL and the outcomes of interest: 34 (71%) on various cancers, nine (19%) on cardiovascular disease, five (10%) on type 2 diabetes, and three (6%) on all-cause mortality. Consumption of high GI foods was associated with an increased incidence of type 2 diabetes (RR 1·27 [95% CI 1·21-1·34]; p<0·0001), total cardiovascular disease (1·15 [1·11-1·19]; p<0·0001), diabetes-related cancer (1·05 [1·02-1·08]; p=0·0010), and all-cause mortality (1·08 [1·05-1·12]; p<0·0001). Similar associations were seen between high GL and diabetes (RR 1·15 [95% CI 1·09-1·21]; p<0·0001) and total cardiovascular disease (1·15 [1·10-1·20]; p<0·0001). Associations between diets high in fibre and whole grains and the four main outcomes were similar to those for low GI diets. INTERPRETATION: Dietary recommendations to reduce GI and GL could have effects on health outcomes that are similar to outcomes of recommendations to increase intake of fibre and whole grain. FUNDING: Banting and Best and the Karuna Foundation.

Global Prevalence of Psychological Distress and Comorbidity With Disorders of Gut-Brain Interactions.

INTRODUCTION: This study focused on defining the global prevalence of clinically relevant levels of psychological distress and somatic symptoms and the prevalence of coexistence between these symptoms and disorders of gut-brain interaction (DGBI). We also analyzed how clinically relevant psychological distress and somatic symptoms and coexistent DGBI are associated with health-related outcomes. METHODS: We included a representative sample of 54,127 adult participants (49.1% women; mean age of 44.3 years) from 26 countries worldwide. Participants completed an Internet survey (the Rome Foundation Global Epidemiology Study) with validated self-report questionnaires. RESULTS: Clinically relevant psychological distress and/or somatic symptom severity was reported by 37.5% of the sample. These participants had 4.45 times higher odds to have at least one DGBI than individuals without psychological distress and/or somatic symptoms. Compared with participants with psychological distress and/or somatic symptoms with vs without DGBI, participants with a DGBI reported increased healthcare and medication utilization (with OR from 1.6 to 2.8). Coexistent DGBI in participants with psychological distress and/or somatic symptoms was the variable most strongly associated with reduced mental (ß = -0.77; confidence interval [-0.86 to -0.68]) and physical (ß = -1.17; confidence interval [-1.24 to -1.10]) quality of life. DISCUSSION: This global study shows that psychological distress, somatic symptoms, and DGBI are very common and frequently overlap. The coexistence between psychological distress/somatic symptoms and DGBI seems to be especially detrimental to quality of life and healthcare utilization. Individuals with psychological distress/somatic symptoms and DGBI coexistence seem to be a group vulnerable to psychosocial problems that should be studied further and would likely benefit from psychological/psychiatric interventions.

Safety and efficacy of factor XIa inhibition with milvexian for secondary stroke prevention (AXIOMATIC-SSP): a phase 2, international, randomised, double-blind, placebo-controlled, dose-finding trial.

BACKGROUND: People with factor XI deficiency have lower rates of ischaemic stroke than the general population and infrequent spontaneous bleeding, suggesting that factor XI has a more important role in thrombosis than in haemostasis. Milvexian, an oral small-molecule inhibitor of activated factor XI, added to standard antiplatelet therapy, might reduce the risk of non-cardioembolic ischaemic stroke without increasing the risk of bleeding. We aimed to estimate the dose-response of milvexian for recurrent ischaemic cerebral events and major bleeding in patients with recent ischaemic stroke or transient ischaemic attack (TIA). METHODS: AXIOMATIC-SSP was a phase 2, randomised, double-blind, placebo-controlled, dose-finding trial done at 367 hospitals in 27 countries. Eligible participants aged 40 years or older, with acute (<48 h) ischaemic stroke or high-risk TIA, were randomly assigned by a web-based interactive response system in a 1:1:1:1:1:2 ratio to receive one of five doses of milvexian (25 mg once daily, 25 mg twice daily, 50 mg twice daily, 100 mg twice daily, or 200 mg twice daily) or matching placebo twice daily for 90 days. All participants received clopidogrel 75 mg daily for the first 21 days and aspirin 100 mg daily for the first 90 days. Investigators, site staff, and participants were masked to treatment assignment. The primary efficacy endpoint was the composite of ischaemic stroke or incident covert brain infarct on MRI at 90 days, assessed in all participants allocated to treatment who completed a follow-up MRI brain scan, and the primary analysis assessed the dose-response relationship with Multiple Comparison Procedure-Modelling (MCP-MOD). The main safety outcome was major bleeding at 90 days, assessed in all participants who received at least one dose of the study drug. This trial is registered with ClinicalTrials.gov (NCT03766581) and the EU Clinical Trials Register (2017-005029-19). FINDINGS: Between Jan 27, 2019, and Dec 24, 2021, 2366 participants were randomly allocated to placebo (n=691); milvexian 25 mg once daily (n=328); or twice-daily doses of milvexian 25 mg (n=318), 50 mg (n=328), 100 mg (n=310), or 200 mg (n=351). The median age of participants was 71 (IQR 62-77) years and 859 (36%) were female. At 90 days, the estimates of the percentage of participants with either symptomatic ischaemic stroke or covert brain infarcts were 16·8 (90·2% CI 14·5-19·1) for placebo, 16·7 (14·8-18·6) for 25 mg milvexian once daily, 16·6 (14·8-18·3) for 25 mg twice daily, 15·6 (13·9-17·5) for 50 mg twice daily, 15·4 (13·4-17·6) for 100 mg twice daily, and 15·3 (12·8-19·7) for 200 mg twice daily. No significant dose-response was observed among the five milvexian doses for the primary composite efficacy outcome. Model-based estimates of the relative risk with milvexian compared with placebo were 0·99 (90·2% CI 0·91-1·05) for 25 mg once daily, 0·99 (0·87-1·11) for 25 mg twice daily, 0·93 (0·78-1·11) for 50 mg twice daily, 0·92 (0·75-1·13) for 100 mg twice daily, and 0·91 (0·72-1·26) for 200 mg twice daily. No apparent dose-response was observed for major bleeding (four [1%] of 682 participants with placebo, two [1%] of 325 with milvexian 25 mg once daily, two [1%] of 313 with 25 mg twice daily, five [2%] of 325 with 50 mg twice daily, five [2%] of 306 with 100 mg twice daily, and five [1%] of 344 with 200 mg twice daily). Five treatment-emergent deaths occurred, four of which were considered unrelated to the study drug by the investigator. INTERPRETATION: Factor XIa inhibition with milvexian, added to dual antiplatelet therapy, did not substantially reduce the composite outcome of symptomatic ischaemic stroke or covert brain infarction and did not meaningfully increase the risk of major bleeding. Findings from our study have informed the design of a phase 3 trial of milvexian for the prevention of ischaemic stroke in patients with acute ischaemic stroke or TIA. FUNDING: Bristol Myers Squibb and Janssen Research & Development.

The Cost-Effectiveness of Rivaroxaban Plus Aspirin Compared with Aspirin Alone in the COMPASS Trial: A US Perspective.

BACKGROUND: Rivaroxaban 2.5 mg twice daily with aspirin 100 mg daily was shown to be better than aspirin 100 mg daily for preventing cardiovascular (CV) death, stroke or myocardial infarction in patients with either stable coronary artery disease (CAD) or peripheral artery disease (PAD). The cost-effectiveness of this regimen in this population is essential for decision-makers to know. METHODS: US direct healthcare system costs (in USD) were applied to hospitalized events, procedures and study drugs utilized by all patients. We determined the mean cost per participant for the full duration of the trial (mean follow-up of 23 months) plus quality-adjusted life years (QALYs) and the incremental cost-effectiveness ratio (ICER) over a lifetime using a two-state Markov model with 1-year cycle length. Sensitivity analyses were performed on the price of rivaroxaban and the annual discontinuation rate. RESULTS: The costs of events and procedures were reduced for Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) patients who received rivaroxaban 2.5 mg orally (BID) plus acetylsalicylic acid (ASA) compared with ASA alone. Total costs were higher for the combination group ($7426 versus $4173) after considering acquisition costs of the study drug. Over a lifetime, patients receiving rivaroxaban plus ASA incurred $27,255 more and gained 1.17 QALYs compared with those receiving ASA alone resulting in an ICER of $23,295/QALY. ICERs for PAD only and polyvascular disease subgroups were lower. CONCLUSION: Rivaroxaban 2.5 mg BID plus ASA compared with ASA alone was cost-effective (high value) in the USA. COMPASS ClinicalTrials.gov identifier: NCT01776424.

Strengthening Community Roots: Anchoring Newcomers in Wellness and Sustainability (SCORE!): A protocol for the co-design and evaluation of a healthy active living program among a newcomer community in Canada.

BACKGROUND: The burden of childhood obesity and cardiometabolic risk factors affecting newcomer Canadians living in lower socioeconomic circumstances is a concerning public health issue. This paper describes Strengthening Community Roots: Anchoring Newcomers in Wellness and Sustainability (SCORE!), an academic-community research partnership to co-design interventions that nurture and optimize healthy activity living (HAL) among a community of children and families new to Canada in Hamilton, Ontario, Canada. METHODS/DESIGN: Our overarching program is informed by a socio-ecological model, and will co-create HAL interventions for children and families new to Canada rooted in outdoor, nature-based physical activity. We will proceed in three phases: Phase 1) synthesis of existing evidence regarding nature based HAL interventions among children and families; Phase 2) program development through four data collection activities including: i) community engagement activities to build trustful relationships and understand barriers and facilitators, including establishing a community advisory and action board, qualitative studies including a photovoice study, and co-design workshops to develop programs; ii) characterizing the demographics of the community through a household survey; iii) characterizing the built environment and HAL programs/services available in the community by developing an accessible real-time systems map; and iv) reviewing municipal policies relevant to HAL and sustainability; leading to Phase 3) implementation and evaluation of the feasibility of co-designed HAL programs. CONCLUSION: The etiology of childhood obesity and related chronic diseases is complex and multifactorial, as are intervention strategies. The SCORE! program of research brings together partners including community members, service providers, academic researchers, and organizational leaders to build a multi-component intervention that promotes the health and wellness of newcomer children and families.

When to p and when not to p.

The p-value was proposed in the early 20th century as a potentially useful metric for statistical inference and was defined as "the probability of the observed result, plus more extreme results, if the null hypothesis were true," in the context of a formal statistical testing process. A century later, the scientific community uses it extensively, mostly inappropriately, and often interprets it incorrectly. This editorial briefly reviews the history of the p-value, provides how to properly interpret it, and recommends when to use it and when not to use it.

Work productivity and activity impairment in disorders of gut-brain interaction: Data from the Rome Foundation Global Epidemiology Study.

BACKGROUND: Disorders of Gut-Brain Interaction (DGBI) are highly prevalent worldwide, but their effect on work productivity has not gained much attention. AIMS AND METHODS: We aimed to compare work productivity and activity impairment (WPAI) in persons with and without DGBI in a large population-based cohort and identify factors independently associated with WPAI in subjects with DGBI. Data were collected from Germany, Israel, Italy, Japan, the Netherlands, Poland, Spain and Sweden via Internet surveys as part of the Rome Foundation Global Epidemiology Study. Apart from the Rome IV diagnostic questionnaire, questionnaires evaluating WPAI related to general health (WPAI:GH), psychological distress (PHQ-4), somatic symptom severity (PHQ-15) and other factors were assessed. RESULTS: Of the 16,820 subjects, 7111 met the criteria for DGBI according to the Rome IV diagnostic questionnaire. Subjects with DGBI were younger (median (interquartile range) age 43 (31-58) vs. 47 (33-62)) and more often female (59.0% vs. 43.7%) compared to subjects without DGBI. Subjects with DGBI had higher absenteeism, presenteeism (poor work productivity due to illness), overall work impairment and activity impairment (p < 0.001) compared with subjects without. For subjects with DGBI affecting more than one anatomical region, WPAI was incrementally higher for each additional region. There were significant differences in WPAI for subjects with DGBI in different countries. Subjects from Sweden had the highest overall work impairment and from Poland the lowest. Using multiple linear regression, male sex, fatigue, psychological distress, somatic symptom severity and number of anatomical regions were independently associated with overall work impairment (p < 0.05 for all). CONCLUSION: In the general population, people with DGBI have substantial WPAI compared with those without DGBI. The reasons for these findings should be explored further, but having multiple DGBI, psychological distress, fatigue and somatic symptom severity seem to contribute to this impairment associated with DGBI.

Prevalence and Associated Factors of Bloating: Results From the Rome Foundation Global Epidemiology Study.

BACKGROUND & AIMS: Bloating is a common symptom in the general population and among disorders of gut-brain interaction, although its prevalence has not been well characterized. The aim of this study was to report the prevalence of bloating as a symptom in the worldwide population and to identify factors associated with this symptom in the general population. METHODS: Rome Foundation Global Epidemiology Study internet survey data were analyzed. After excluding respondents with potential organic causes of bowel symptoms, the current analysis included 51,425 individuals in 26 countries. Data included diet, medical history, quality of life, and Rome IV diagnostic questions. Presence of bloating was defined as experiencing bloating at least once per week for the last 3 months. Descriptive statistics estimated prevalence by country, region, and disorder of gut-brain interaction diagnosis. Logistic regression evaluated predictors of bloating. RESULTS: Nearly 18% of the global study population reported bloating (ranging from 11% in East Asia to 20% in Latin America). Prevalence decreased with age and women were approximately twice as likely as men to report bloating. More than one-half of respondents who reported weekly epigastric pain (71.39%), nausea (59.7%), or abdominal pain (61.69%) also reported bloating at least once per week. In logistic regression, the strongest associations were with abdominal pain (odds ratio, 2.90) and epigastric pain (odds ratio, 2.07). CONCLUSIONS: Bloating is common throughout the world. Nearly 18% of the general population experience bloating at least once per week. Reported bloating prevalence is lower in older age groups, most common in women, and strongly associated with abdominal pain.

Exact correction factor for estimating the OR in the presence of sparse data with a zero cell in 2 × 2 tables.

In case-control studies, odds ratios (OR) are calculated from 2 × 2 tables and in some instances, we observe small cell counts or zero counts in one of the cells. The corrections to calculate the ORs in the presence of empty cells are available in literature. Some of these include Yates continuity correction and Agresti and Coull correction. However, the available methods provided different corrections and the situations where each could be applied are not very apparent. Therefore, the current research proposes an iterative algorithm of estimating an exact (optimum) correction factor for the respective sample size. This was evaluated by simulating data with varying proportions and sample sizes. The estimated correction factor was considered after obtaining the bias, standard error of odds ratio, root mean square error and the coverage probability. Also, we have presented a linear function to identify the exact correction factor using sample size and proportion.

A culturally tailored personaliseD nutrition intErvention in South ASIan women at risk of Gestational Diabetes Mellitus (DESI-GDM): a randomised controlled trial protocol.

INTRODUCTION: South Asians are more likely to develop gestational diabetes mellitus (GDM) than white Europeans. Diet and lifestyle modifications may prevent GDM and reduce undesirable outcomes in both the mother and offspring. Our study seeks to evaluate the effectiveness and participant acceptability of a culturally tailored, personalised nutrition intervention on the glucose area under the curve (AUC) after a 2-hour 75 g oral glucose tolerance test (OGTT) in pregnant women of South Asian ancestry with GDM risk factors. METHODS AND ANALYSIS: A total of 190 South Asian pregnant women with at least 2 of the following GDM risk factors-prepregnancy body mass index>23, age>29, poor-quality diet, family history of type 2 diabetes in a first-degree relative or GDM in a previous pregnancy will be enrolled during gestational weeks 12-18, and randomly assigned in a 1:1 ratio to: (1) usual care, plus weekly text messages to encourage walking and paper handouts or (2) a personalised nutrition plan developed and delivered by a culturally congruent dietitian and health coach; and FitBit to track steps. The intervention lasts 6-16 weeks, depending on week of recruitment. The primary outcome is the glucose AUC from a three-sample 75 g OGTT 24-28 weeks' gestation. The secondary outcome is GDM diagnosis, based on Born-in-Bradford criteria (fasting glucose>5.2 mmol/L or 2 hours post load>7.2 mmol/L). ETHICS AND DISSEMINATION: The study has been approved by the Hamilton Integrated Research Ethics Board (HiREB #10942). Findings will be disseminated among academics and policy-makers through scientific publications along with community-orientated strategies. TRIAL REGISTRATION NUMBER: NCT03607799.

Comparisons of the Rome III and Rome IV criteria for diagnosis of irritable bowel syndrome in Indian and Bangladeshi communities and internal shifts in the diagnostic categories of bowel disorders of gut-brain interactions.

BACKGROUND: Although the Rome IV criteria are the most recent criteria to diagnose irritable bowel syndrome (IBS), their sensitivity has been shown to be low in Chinese and Western populations. There are scanty data comparing the Rome III and Rome IV criteria in diagnosis of IBS in the Indian and Bangladeshi populations where abdominal pain, an essential component of diagnosis of IBS by the Rome IV criteria, is less in frequency and of lower severity. METHODS: We analyzed the Indian and Bangladeshi data from the Rome Global Epidemiology Study to compare diagnostic sensitivity of the Rome III and Rome IV criteria for IBS, internal shifts in diagnostic categories of disorders of gut-brain interaction (DGBI), the severity of IBS diagnosed by the Rome III and Rome IV criteria, and consultation patterns in these populations. KEY RESULTS: The Rome IV criteria were less sensitive than the Rome III criteria to diagnose IBS in these populations, and the subjects with Rome III IBS shifted internally to other DGBI when the Rome IV criteria were applied. Moreover, Rome IV IBS subjects had greater symptom severity than the Rome III IBS. A third of people fulfilling diagnostic criteria for IBS consulted doctors, and those diagnosed using Rome IV criteria, those with higher anxiety and depression symptom score, lower global physical health score, and greater IBS symptom severity score had greater correlation coefficients with doctors' consultation. CONCLUSIONS AND INFERENCES: The Rome IV diagnostic criteria for IBS are less sensitive than the Rome III criteria in Indian and Bangladesh communities. Application of the Rome IV criteria to people who meet the Rome III IBS criteria selects a subgroup of people with greater severity of symptoms, and hence, Rome IV IBS is more strongly associated with physician consultation. These findings may have important bearing in future iterations of the Rome criteria for a broader global applicability.

Prevalence and description of disorders of gut-brain interaction in Spain according to the results of the Rome Foundation Global Epidemiology Study.

BACKGROUND: Data for Spain from the Rome Foundation Global Epidemiology Study on the disorders of gut-brain interaction (DGBI) were used to assess the national and regional prevalence of all 22 DGBI, the percentage of respondents meeting diagnostic criteria for at least one DGBI, and the impact on burden of disease in our country. METHODS: Data were collected through an anonymous, nationwide, and secure Internet survey with multiple built-in quality-assurance techniques that included the Rome IV diagnostic questionnaire and an in-depth supplemental questionnaire. KEY RESULTS: The survey was completed by 2072 adult Spanish participants (50.2% female) with a mean age of 45.67 ± 15.44 years with a good representative national distribution. 43.6% (41.5%-45.8%) met diagnostic criteria for at least one DGBI, with 8.2% for any esophageal disorder, 12.1% for any gastroduodenal disorder, 30.1% for any bowel disorder, and 11.5% for any anorectal disorder. Functional constipation was the most prevalent DGBI in Spain (12.8%). We found that proctalgia fugax (9.3%), unspecified bowel disorders (10.8%), and functional dysphagia (5.6%) showed unexplained high rates in our country. DGBI rates were higher for women. Having any DGBI was negatively associated with psychosocial variables (including quality of life, somatization, and concern about digestive problems), and associated with increased healthcare utilization. CONCLUSIONS & INFERENCES: We provide the first comprehensive data on the prevalence and burden of all DGBI in Spain using the Rome IV criteria. The enormous burden of DGBI in Spain highlights the need for specialized training and future research.

Pictograms to assess bloating and distension symptoms in the general population in Mexico: Results of The Rome Foundation Global Epidemiology Study.

BACKGROUND: There is no term for bloating in Spanish and distension is a very technical word. "Inflammation"/"swelling" are the most frequently used expressions for bloating/distension in Mexico, and pictograms are more effective than verbal descriptors (VDs) for bloating/distension in general GI and Rome III-IBS patients. However, their effectiveness in the general population and in subjects with Rome IV-DGBI is unknown. We analyzed the use of pictograms for assessing bloating/distension in the general population in Mexico. METHODS: The Rome Foundation Global Epidemiology Study (RFGES) in Mexico (n = 2001) included questions about the presence of VDs "inflammation"/"swelling" and abdominal distension, their comprehension, and pictograms (normal, bloating, distension, both). We compared the pictograms with the Rome IV question about the frequency of experiencing bloating/distension, and with the VDs. KEY RESULTS: "Inflammation"/"swelling" was reported by 51.5% and distension by 23.8% of the entire study population; while 1.2% and 25.3% did not comprehend "Inflammation"/"swelling" or distension, respectively. Subjects without (31.8%) or not comprehending "inflammation"/"swelling"/distension (68.4%) reported bloating/distension by pictograms. Bloating and/or distension by the pictograms were much more frequent in those with DGBI: 38.3% (95%CI: 31.7-44.9) vs. without: 14.5% (12.0-17.0); and in subjects with distension by VDs: 29.4% (25.4-33.3) vs. without: 17.2% (14.9-19.5). Among subjects with bowel disorders, those with IBS reported bloating/distension by pictograms the most (93.8%) and those with functional diarrhea the least (71.4%). CONCLUSIONS & INFERENCES: Pictograms are more effective than VDs for assessing the presence of bloating/distension in Spanish Mexico. Therefore, they should be used to study these symptoms in epidemiological research.