Validity and reliability of the newly developed Malay-language health belief of bloating (HB-Bloat) scale

Copyright © 2020 by the authors. Abdominal bloating (AB), a common complaint that affects quality of life and disturbs psychological well-being, is largely a behavioral-driven disorder. We aimed to develop and validate a new health belief of bloating (HB-Bloat) scale in the Malay language. The initial item pool was developed based on the theory of planned behavior, empirical literatures, expert review and in-depth interviews. Using the population with bloating (diagnosed based on the Rome IV criteria and pictogram), exploratory and confirmatory factor analytical approaches (EFA and CFA, respectively) were utilized to explore and confirm the domains in the new scale. There were 150 and 323 respondents in the EFA and CFA, respectively. There were 45 items in the initial scale, but it was reduced to 32 items after content validity and pre-testing. In EFA, 17 items with three (3) structure factors (attitude 4 items, subjective norm 7 items, and perceived behavior control 6 items) were identified. Total variance explained by the EFA model was 40.92%. The Cronbach alpha of the three (3) factors ranged from 0.61 to 0.79. With CFA, the three factors model was further tested. Five problematic items were identified and removed. The final measurement model fit the data well (root mean square error of approximation (RMSEA (90% CI) = 0.054 (0.038, 0.070), Comparative Fit Index (CFI) = 0.941, Tucker–Lewis Fit Index (TLI) = 0.924, and standardized root mean squared residual (SRMR) = 0.044). The construct reliability of the final measurement model ranged from 0.76 to 0.84. As a conclusion, the new HB-Bloat scale is a valid and reliable tool for assessment of health beliefs in bloating.School of Medical Sciences Incentives Fund and Research University Individual Grant from Universiti Sains Malaysia (1001.PPSP.8012250)

Development and validation of the Health Promoting Behaviour for Bloating (HPBBloat) scale

© 2021 Abdullah et al. Background Health management strategies may help patients with abdominal bloating (AB), but there are currently no tools that measure behaviour and awareness. This study aimed to validate and verify the dimensionality of the newly-developed Health Promoting Behaviour for Bloating (HPB-Bloat) scale. Methods Based on previous literature, expert input, and in-depth interviews, we generated new items for the HPB-Bloat. Its content validity was assessed by experts and pre-tested across 30 individuals with AB. Construct validity and dimensionality were first determined using exploratory factor analysis (EFA) and Promax rotation analysis, and then using confirmatory factor analysis (CFA). Results During the development stage, 35 items were generated for the HPB-Bloat, and were maintained following content validity assessment and pre-testing. One hundred and fifty-two participants (mean age of 31.27 years, 68.3% female) and 323 participants (mean age of 27.69 years, 59.4% male) completed the scale for EFA and CFA, respectively. Using EFA, we identified 20 items that we divided into five factors: diet (five items), health awareness (four items), physical activity (three items), stress management (four items), and treatment (four items). The total variance explained by the EFA model was 56.7%. The Cronbach alpha values of the five factors ranged between 0.52 and 0.81. In the CFA model, one problematic latent variable (treatment) was identified and three items were removed. In the final measurement model, four factors and 17 items fit the data well based on several fit indices (root mean square error of approximation (RMSEA) = 0.044 and standardized root mean squared residual (SRMR) = 0.052). The composite reliability of all factors in the final measurement model was above 0.60, indicating acceptable construct reliability. Conclusion The newly developed HPB-Bloat scale is valid and reliable when assessing the awareness of health-promoting behaviours across patients with AB. Further validation is needed across different languages and populations.Universiti Sains Malaysia: 1001.PPSP.801225

Validity and reliability of the malay versions of bloating severity (Bsq-m) and quality of life (blqol-m) questionnaires

Copyright: © 2021 by the authors. Abdominal bloating (AB) is a prevalent and bothersome symptom, but there are no specific measures for severity and quality of life (QoL) other than the Bloating Severity Questionnaire (BSQ) and Bloating Quality of Life (BLQoL). We aimed to translate the BSQ and BLQoL into the Malay language and to validate them using exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) approaches. The 12-item BSQ has two components, seven-item severity in general (SevGen) and five-item severity in the past 24 h (Sev24), and BLQOL has five items. Translation to the Malay language (BSQ-M and BLQoL-M) was performed using standard forward and backward processes. EFA followed by CFA were performed in participants with AB due to functional bowel disorders, with the purpose of examining the validity and reliability of the questionnaires translated into Malay. After EFA with 152 participants, all the items of BSQ-M remained in the model. Total variance extracted was 53.26% for BSQ-M and 58.79% for BLQoL-M. The internal consistency based on Cronbach’s alpha values was 0.52 for SevGen, 0.86 for Sev24, and 0.81 for BLQoL-M. After performing CFA with another 323 participants, the final measurement model for BSQ-M and BLQoL-M fit the data well in terms of several fit indices (BSQ-M: root mean square error of approximation (RMSEA) = 0.050, Comparative Fit Index (CFI) = 0.966, Tucker–Lewis Fit Index (TLI) = 0.956, and standardized root mean squared residual (SRMR) = 0.051; BLQoL-M: RMSEA = 0.071, CFI = 0.985, TLI = 0.962, SRMR = 0.021). The composite reliability for BSQ-M and BLQoL-M were satisfactory (SevGen = 0.83, Sev24 = 0.89, BLQoL = 0.80). The intraclass correlation (ICC) results showed excellent stability for BSQ-M and BLQoL-M, ranging from 0.74 to 0.93. The Malay language versions of BSQ-M and BLQoL-M are valid and reliable instruments for measuring the severity and QoL of AB for the Asian population with functional bowel disorders.School of Medical Sciences, Education Incentive Fund (or TIPPS); Research University Individual Grant from Universiti Sains Malaysia (1001.PPSP.8012250)

Impact of primary kidney disease on the effects of empagliflozin in patients with chronic kidney disease: secondary analyses of the EMPA-KIDNEY trial

Background: The EMPA-KIDNEY trial showed that empagliflozin reduced the risk of the primary composite outcome of kidney disease progression or cardiovascular death in patients with chronic kidney disease mainly through slowing progression. We aimed to assess how effects of empagliflozin might differ by primary kidney disease across its broad population. Methods: EMPA-KIDNEY, a randomised, controlled, phase 3 trial, was conducted at 241 centres in eight countries (Canada, China, Germany, Italy, Japan, Malaysia, the UK, and the USA). Patients were eligible if their estimated glomerular filtration rate (eGFR) was 20 to less than 45 mL/min per 1·73 m2, or 45 to less than 90 mL/min per 1·73 m2 with a urinary albumin-to-creatinine ratio (uACR) of 200 mg/g or higher at screening. They were randomly assigned (1:1) to 10 mg oral empagliflozin once daily or matching placebo. Effects on kidney disease progression (defined as a sustained ≥40% eGFR decline from randomisation, end-stage kidney disease, a sustained eGFR below 10 mL/min per 1·73 m2, or death from kidney failure) were assessed using prespecified Cox models, and eGFR slope analyses used shared parameter models. Subgroup comparisons were performed by including relevant interaction terms in models. EMPA-KIDNEY is registered with ClinicalTrials.gov, NCT03594110. Findings: Between May 15, 2019, and April 16, 2021, 6609 participants were randomly assigned and followed up for a median of 2·0 years (IQR 1·5-2·4). Prespecified subgroupings by primary kidney disease included 2057 (31·1%) participants with diabetic kidney disease, 1669 (25·3%) with glomerular disease, 1445 (21·9%) with hypertensive or renovascular disease, and 1438 (21·8%) with other or unknown causes. Kidney disease progression occurred in 384 (11·6%) of 3304 patients in the empagliflozin group and 504 (15·2%) of 3305 patients in the placebo group (hazard ratio 0·71 [95% CI 0·62-0·81]), with no evidence that the relative effect size varied significantly by primary kidney disease (pheterogeneity=0·62). The between-group difference in chronic eGFR slopes (ie, from 2 months to final follow-up) was 1·37 mL/min per 1·73 m2 per year (95% CI 1·16-1·59), representing a 50% (42-58) reduction in the rate of chronic eGFR decline. This relative effect of empagliflozin on chronic eGFR slope was similar in analyses by different primary kidney diseases, including in explorations by type of glomerular disease and diabetes (p values for heterogeneity all >0·1). Interpretation: In a broad range of patients with chronic kidney disease at risk of progression, including a wide range of non-diabetic causes of chronic kidney disease, empagliflozin reduced risk of kidney disease progression. Relative effect sizes were broadly similar irrespective of the cause of primary kidney disease, suggesting that SGLT2 inhibitors should be part of a standard of care to minimise risk of kidney failure in chronic kidney disease. Funding: Boehringer Ingelheim, Eli Lilly, and UK Medical Research Council

Effects of empagliflozin on progression of chronic kidney disease: a prespecified secondary analysis from the empa-kidney trial

Background: Sodium-glucose co-transporter-2 (SGLT2) inhibitors reduce progression of chronic kidney disease and the risk of cardiovascular morbidity and mortality in a wide range of patients. However, their effects on kidney disease progression in some patients with chronic kidney disease are unclear because few clinical kidney outcomes occurred among such patients in the completed trials. In particular, some guidelines stratify their level of recommendation about who should be treated with SGLT2 inhibitors based on diabetes status and albuminuria. We aimed to assess the effects of empagliflozin on progression of chronic kidney disease both overall and among specific types of participants in the EMPA-KIDNEY trial. Methods: EMPA-KIDNEY, a randomised, controlled, phase 3 trial, was conducted at 241 centres in eight countries (Canada, China, Germany, Italy, Japan, Malaysia, the UK, and the USA), and included individuals aged 18 years or older with an estimated glomerular filtration rate (eGFR) of 20 to less than 45 mL/min per 1·73 m2, or with an eGFR of 45 to less than 90 mL/min per 1·73 m2 with a urinary albumin-to-creatinine ratio (uACR) of 200 mg/g or higher. We explored the effects of 10 mg oral empagliflozin once daily versus placebo on the annualised rate of change in estimated glomerular filtration rate (eGFR slope), a tertiary outcome. We studied the acute slope (from randomisation to 2 months) and chronic slope (from 2 months onwards) separately, using shared parameter models to estimate the latter. Analyses were done in all randomly assigned participants by intention to treat. EMPA-KIDNEY is registered at ClinicalTrials.gov, NCT03594110. Findings: Between May 15, 2019, and April 16, 2021, 6609 participants were randomly assigned and then followed up for a median of 2·0 years (IQR 1·5-2·4). Prespecified subgroups of eGFR included 2282 (34·5%) participants with an eGFR of less than 30 mL/min per 1·73 m2, 2928 (44·3%) with an eGFR of 30 to less than 45 mL/min per 1·73 m2, and 1399 (21·2%) with an eGFR 45 mL/min per 1·73 m2 or higher. Prespecified subgroups of uACR included 1328 (20·1%) with a uACR of less than 30 mg/g, 1864 (28·2%) with a uACR of 30 to 300 mg/g, and 3417 (51·7%) with a uACR of more than 300 mg/g. Overall, allocation to empagliflozin caused an acute 2·12 mL/min per 1·73 m2 (95% CI 1·83-2·41) reduction in eGFR, equivalent to a 6% (5-6) dip in the first 2 months. After this, it halved the chronic slope from -2·75 to -1·37 mL/min per 1·73 m2 per year (relative difference 50%, 95% CI 42-58). The absolute and relative benefits of empagliflozin on the magnitude of the chronic slope varied significantly depending on diabetes status and baseline levels of eGFR and uACR. In particular, the absolute difference in chronic slopes was lower in patients with lower baseline uACR, but because this group progressed more slowly than those with higher uACR, this translated to a larger relative difference in chronic slopes in this group (86% [36-136] reduction in the chronic slope among those with baseline uACR <30 mg/g compared with a 29% [19-38] reduction for those with baseline uACR ≥2000 mg/g; ptrend<0·0001). Interpretation: Empagliflozin slowed the rate of progression of chronic kidney disease among all types of participant in the EMPA-KIDNEY trial, including those with little albuminuria. Albuminuria alone should not be used to determine whether to treat with an SGLT2 inhibitor. Funding: Boehringer Ingelheim and Eli Lilly

Global fertility in 204 countries and territories, 1950–2021, with forecasts to 2100: a comprehensive demographic analysis for the Global Burden of Disease Study 2021

BackgroundAccurate assessments of current and future fertility—including overall trends and changing population age structures across countries and regions—are essential to help plan for the profound social, economic, environmental, and geopolitical challenges that these changes will bring. Estimates and projections of fertility are necessary to inform policies involving resource and health-care needs, labour supply, education, gender equality, and family planning and support. The Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2021 produced up-to-date and comprehensive demographic assessments of key fertility indicators at global, regional, and national levels from 1950 to 2021 and forecast fertility metrics to 2100 based on a reference scenario and key policy-dependent alternative scenarios.MethodsTo estimate fertility indicators from 1950 to 2021, mixed-effects regression models and spatiotemporal Gaussian process regression were used to synthesise data from 8709 country-years of vital and sample registrations, 1455 surveys and censuses, and 150 other sources, and to generate age-specific fertility rates (ASFRs) for 5-year age groups from age 10 years to 54 years. ASFRs were summed across age groups to produce estimates of total fertility rate (TFR). Livebirths were calculated by multiplying ASFR and age-specific female population, then summing across ages 10–54 years. To forecast future fertility up to 2100, our Institute for Health Metrics and Evaluation (IHME) forecasting model was based on projections of completed cohort fertility at age 50 years (CCF50; the average number of children born over time to females from a specified birth cohort), which yields more stable and accurate measures of fertility than directly modelling TFR. CCF50 was modelled using an ensemble approach in which three sub-models (with two, three, and four covariates variously consisting of female educational attainment, contraceptive met need, population density in habitable areas, and under-5 mortality) were given equal weights, and analyses were conducted utilising the MR-BRT (meta-regression—Bayesian, regularised, trimmed) tool. To capture time-series trends in CCF50 not explained by these covariates, we used a first-order autoregressive model on the residual term. CCF50 as a proportion of each 5-year ASFR was predicted using a linear mixed-effects model with fixed-effects covariates (female educational attainment and contraceptive met need) and random intercepts for geographical regions. Projected TFRs were then computed for each calendar year as the sum of single-year ASFRs across age groups. The reference forecast is our estimate of the most likely fertility future given the model, past fertility, forecasts of covariates, and historical relationships between covariates and fertility. We additionally produced forecasts for multiple alternative scenarios in each location: the UN Sustainable Development Goal (SDG) for education is achieved by 2030; the contraceptive met need SDG is achieved by 2030; pro-natal policies are enacted to create supportive environments for those who give birth; and the previous three scenarios combined. Uncertainty from past data inputs and model estimation was propagated throughout analyses by taking 1000 draws for past and present fertility estimates and 500 draws for future forecasts from the estimated distribution for each metric, with 95% uncertainty intervals (UIs) given as the 2·5 and 97·5 percentiles of the draws. To evaluate the forecasting performance of our model and others, we computed skill values—a metric assessing gain in forecasting accuracy—by comparing predicted versus observed ASFRs from the past 15 years (2007–21). A positive skill metric indicates that the model being evaluated performs better than the baseline model (here, a simplified model holding 2007 values constant in the future), and a negative metric indicates that the evaluated model performs worse than baseline.FindingsDuring the period from 1950 to 2021, global TFR more than halved, from 4·84 (95% UI 4·63–5·06) to 2·23 (2·09–2·38). Global annual livebirths peaked in 2016 at 142 million (95% UI 137–147), declining to 129 million (121–138) in 2021. Fertility rates declined in all countries and territories since 1950, with TFR remaining above 2·1—canonically considered replacement-level fertility—in 94 (46·1%) countries and territories in 2021. This included 44 of 46 countries in sub-Saharan Africa, which was the super-region with the largest share of livebirths in 2021 (29·2% [28·7–29·6]). 47 countries and territories in which lowest estimated fertility between 1950 and 2021 was below replacement experienced one or more subsequent years with higher fertility; only three of these locations rebounded above replacement levels. Future fertility rates were projected to continue to decline worldwide, reaching a global TFR of 1·83 (1·59–2·08) in 2050 and 1·59 (1·25–1·96) in 2100 under the reference scenario. The number of countries and territories with fertility rates remaining above replacement was forecast to be 49 (24·0%) in 2050 and only six (2·9%) in 2100, with three of these six countries included in the 2021 World Bank-defined low-income group, all located in the GBD super-region of sub-Saharan Africa. The proportion of livebirths occurring in sub-Saharan Africa was forecast to increase to more than half of the world's livebirths in 2100, to 41·3% (39·6–43·1) in 2050 and 54·3% (47·1–59·5) in 2100. The share of livebirths was projected to decline between 2021 and 2100 in most of the six other super-regions—decreasing, for example, in south Asia from 24·8% (23·7–25·8) in 2021 to 16·7% (14·3–19·1) in 2050 and 7·1% (4·4–10·1) in 2100—but was forecast to increase modestly in the north Africa and Middle East and high-income super-regions. Forecast estimates for the alternative combined scenario suggest that meeting SDG targets for education and contraceptive met need, as well as implementing pro-natal policies, would result in global TFRs of 1·65 (1·40–1·92) in 2050 and 1·62 (1·35–1·95) in 2100. The forecasting skill metric values for the IHME model were positive across all age groups, indicating that the model is better than the constant prediction.InterpretationFertility is declining globally, with rates in more than half of all countries and territories in 2021 below replacement level. Trends since 2000 show considerable heterogeneity in the steepness of declines, and only a small number of countries experienced even a slight fertility rebound after their lowest observed rate, with none reaching replacement level. Additionally, the distribution of livebirths across the globe is shifting, with a greater proportion occurring in the lowest-income countries. Future fertility rates will continue to decline worldwide and will remain low even under successful implementation of pro-natal policies. These changes will have far-reaching economic and societal consequences due to ageing populations and declining workforces in higher-income countries, combined with an increasing share of livebirths among the already poorest regions of the world.</p