Mixed-methods study protocol to identify expectations of people with type 1 diabetes and their caregivers about voice-based digital health solutions to support the management of diabetes distress: the PsyVoice study.

INTRODUCTION: Type 1 diabetes (T1D) requires continuous management to obtain a good metabolic control and prevent acute complications. This often affects psychological well-being. People with T1D frequently report diabetes distress (DD). Psychological issues can negatively affect metabolic control and well-being. New technologies can improve quality of life, reduce the treatment burden and improve glycaemic control. Voice technology may serve as an innovative and inexpensive remote monitoring device to evaluate psychological well-being. Tailoring digital health interventions according to the ability and interest of their intended 'end-users' increases the acceptability of the intervention itself. PsyVoice explores the perspectives and needs of people with T1D on voice-based digital health interventions to manage DD. METHODS AND ANALYSIS: PsyVoice is a mixed-methods study with qualitative and quantitative data sources. For the qualitative part, the researchers will invite 20 people with a T1D or caregivers of children with T1D to participate in in-depth semi-structured interviews. They will be invited as well to answer three questionnaires to assess socio-demographics, diabetes management, e-Health literacy and diabetes distress. Information from questionnaires will be integrated with themes developed in the qualitative analysis of the interviews. People with T1D will be invited to participate in the protocol and give feedback on interview guides, questionnaires, information sheets and informed consent. ETHICS AND DISSEMINATION: PsyVoice received ethical approval from Luxembourg's National Research Ethics Committee. Participants will receive information about the purpose, risks and strategies to ensure the confidentiality and anonymity of the study. The results of PsyVoice will guide the selection and development of voice-based technological interventions for managing DD. The outcome will be disseminated to academic and non-academic stakeholders through peer-reviewed open-access journals and a lay public report. TRIAL REGISTRATION NUMBER: This study is registered on ClinicalTrials.gov with the number NCT05517772.

Temporal trends in obesity defined by the relative fat mass (RFM) index among adults in the United States from 1999 to 2020: a population-based study.

OBJECTIVES: The body mass index (BMI) largely underestimates excess body fat, suggesting that the prevalence of obesity could be underestimated. Biologically, women are known to have higher body fat than men. This study aimed to compare the temporal trends in general obesity by sex, ethnicity and age among adults in the USA using the relative fat mass (RFM), a validated surrogate for whole-body fat percentage and BMI. DESIGN: Population-based study. SETTING: US National Health and Nutrition Examination Survey, from 1999-2000 to 2017-March 2020. PARTICIPANTS: A representative sample of adults 20-79 years in the USA. MAIN OUTCOME MEASURES: Age-adjusted prevalence of general obesity. RFM-defined obesity was diagnosed using validated cut-offs to predict all-cause mortality: RFM≥40% for women and ≥30% for men. BMI-defined obesity was diagnosed using a cut-off of 30 kg/m2. RESULTS: Analysis included data from 47 667 adults. Among women, RFM-defined obesity prevalence was 64.7% (95% CI 62.1% to 67.3%) in 2017-2020, a linear increase of 13.9 percentage points (95% CI 9.0% to 18.9%; p<0.001) relative to 1999-2000. In contrast, the prevalence of BMI-defined obesity was 42.2% (95% CI 39.4% to 45.0%) in 2017-2020. Among men, the corresponding RFM-defined obesity prevalence was 45.8% (95% CI 42.0% to 49.7%), a linear increase of 12.0 percentage points (95% CI 6.6% to 17.3%; p<0.001). In contrast, the prevalence of BMI-defined obesity was 42.0 (95% CI 37.8% to 46.3%). The highest prevalence of RFM-defined obesity across years was observed in older adults (60-79 years) and Mexican Americans, in women and men. Conversely, the highest prevalence of BMI-defined obesity across years was observed in middle-age (40-59 years) and older adults, and in African American women. CONCLUSIONS: The use of a surrogate for whole-body fat percentage revealed a much higher prevalence of general obesity in the USA from 1999 to 2020, particularly among women, than that estimated using BMI, and detected a disproportionate higher prevalence of general obesity in older adults and Mexican Americans.

Lower Prevalence of Body Fat-Defined Obesity at Higher Altitudes in Peruvian Adults.

Woolcott, Orison O., Till Seuring, and Oscar A. Castillo. Lower prevalence of body fat-defined obesity at higher altitudes in Peruvian adults. High Alt Med Biol. 24:214-222, 2023. Background: Previous studies have reported a lower prevalence of obesity (defined as a body mass index [BMI] ≥30 kg/m2) in populations from higher altitudes. Since BMI does not distinguish fat mass and fat-free mass, it is unclear whether there is an inverse association between altitude and body fat-defined obesity. Methods: We performed an analysis of cross-sectional data to examine the association between altitude and body fat-defined obesity (as opposed to BMI-defined obesity) using individual-level data from a nationally representative sample of the Peruvian adult population living between 0 and 5,400 m altitude. Body fat-defined obesity was diagnosed using the relative fat mass (RFM), an anthropometric index validated to estimate whole-body fat percentage. RFM cutoffs for obesity diagnosis were ≥40% for women and ≥30% for men. We utilized Poisson regression to estimate the prevalence ratio and confidence intervals (CIs) as the measure of the association, adjusting for age, cigarette use, and diabetes. Results: Analysis comprised 36,727 individuals (median age, 39 years; 50.1% women). In rural areas, for a one-km increase in altitude, the prevalence of body fat-defined obesity decreased by 12% among women (adjusted prevalence ratio: 0.88; 95% CI, 0.86 - 0.90; p < 0.001) and 19% among men (adjusted prevalence ratio: 0.81; 95% CI, 0.77 - 0.86; p < 0.001), on average, when all the other variables were held constant. The inverse association between altitude and obesity was less strong in urban areas than in rural areas but remained significant among women (p = 0.001) and men (p < 0.001). However, the relationship between altitude and obesity in women who live in urban areas appears to be nonlinear. Conclusions: In Peruvian adults, the prevalence of body fat-defined obesity was inversely associated with altitude. Whether this inverse association is explained by altitude per se or confounded by socioeconomic or other environmental factors, or differences in race/ethnicity or lifestyle, warrants further investigation.

The state of diabetes care and obstacles to better care in Aceh, Indonesia: a mixed-methods study.

BACKGROUND: Cardio-metabolic diseases are a major cause of death worldwide, including in Indonesia, where diabetes is one of the most critical diseases for the health system to manage. METHODS: We describe the characteristics, levels of control, health behavior, and diabetes-related complications of diabetes patients in Aceh, Indonesia. We use baseline data and blood testing from a randomized-controlled trial. We conducted semi-structured interviews with eight health providers from Posbindu and Prolanis programs that target diabetes and other non-communicable diseases (NCDs). We also conducted three focus group discussions with 24 diabetes patients about their experiences of living with diabetes and the existing support programs. RESULTS: The blood tests revealed average HbA1c levels indicative of poor glycemic control in 75.8 percent of patients and only 20.3 percent were free from any symptoms. Our qualitative findings suggest that patients are diagnosed after diabetes-related symptoms manifest, and that they find it hard to comply with treatment recommendations and lifestyle advice. The existing programs related to NCDs are not tailored to their needs. CONCLUSION: We identify the need to improve diabetes screening to enable earlier treatment and achieve better control of the disease. Among diagnosed patients, there are widespread beliefs about diabetes medication and alternative forms of treatment that need to be addressed in a respectful dialogue between healthcare professionals and patients. Current diabetes screening, treatment and management programs should be revised to meet the needs of the affected population and to better respond to the increasing burden of this disease.

Methods to Generate Innovative Research Ideas and Improve Patient and Public Involvement in Modern Epidemiological Research: Review, Patient Viewpoint, and Guidelines for Implementation of a Digital Cohort Study.

BACKGROUND: Patient and public involvement (PPI) in research aims to increase the quality and relevance of research by incorporating the perspective of those ultimately affected by the research. Despite these potential benefits, PPI is rarely included in epidemiology protocols. OBJECTIVE: The aim of this study is to provide an overview of methods used for PPI and offer practical recommendations for its efficient implementation in epidemiological research. METHODS: We conducted a review on PPI methods. We mirrored it with a patient advocate's viewpoint about PPI. We then identified key steps to optimize PPI in epidemiological research based on our review and the viewpoint of the patient advocate, taking into account the identification of barriers to, and facilitators of, PPI. From these, we provided practical recommendations to launch a patient-centered cohort study. We used the implementation of a new digital cohort study as an exemplary use case. RESULTS: We analyzed data from 97 studies, of which 58 (60%) were performed in the United Kingdom. The most common methods were workshops (47/97, 48%); surveys (33/97, 34%); meetings, events, or conferences (28/97, 29%); focus groups (25/97, 26%); interviews (23/97, 24%); consensus techniques (8/97, 8%); James Lind Alliance consensus technique (7/97, 7%); social media analysis (6/97, 6%); and experience-based co-design (3/97, 3%). The viewpoint of a patient advocate showed a strong interest in participating in research. The most usual PPI modalities were research ideas (60/97, 62%), co-design (42/97, 43%), defining priorities (31/97, 32%), and participation in data analysis (25/97, 26%). We identified 9 general recommendations and 32 key PPI-related steps that can serve as guidelines to increase the relevance of epidemiological studies. CONCLUSIONS: PPI is a project within a project that contributes to improving knowledge and increasing the relevance of research. PPI methods are mainly used for idea generation. On the basis of our review and case study, we recommend that PPI be included at an early stage and throughout the research cycle and that methods be combined for generation of new ideas. For e-cohorts, the use of digital tools is essential to scale up PPI. We encourage investigators to rely on our practical recommendations to extend PPI in future epidemiological studies.

Using financial incentives to increase physical activity among employees as a strategy of workplace health promotion: protocol for a systematic review.

INTRODUCTION: Shifts towards sedentary occupations in high-income countries (HIC) over the last decades and the health burden associated with physical inactivity have led to innovative strategies to promote physical activity (PA) among the working population. Financial rewards have been proposed to incentivise participation in programmes promoting PA or the achievement of PA-related goals. This review will assess (1) effects of financial incentives provided by employers to promote PA on programme adherence/compliance, PA and closely linked outcomes (eg, days of sick leave), (2) effects according to age, gender, implementation and study quality and (3) intervention costs and cost-effectiveness. METHODS AND ANALYSIS: We will search for relevant studies in eight academic databases, two grey literature resources, two trial registers and on five organisational websites (oldest record/content to present). We will include (cluster) randomised controlled studies with a financial incentive to promote PA as intervention (≥1 months), conducted among employees in HIC and reporting data on at least one primary outcome in stages of screening (title/abstract, full text). To assess study quality and potential bias, we will use the revised Cochrane risk-of-bias tool (RoB 2). We will extract study data into prepiloted extraction sheets. Each task in screening, quality assessment and data extraction will be done by two authors independently. If a sufficient number of studies provide homogeneous data (ie, similar follow-up) for primary outcomes, meta-analyses will be carried out. We will report GRADE ratings to provide information on the certainty of the evidence. ETHICS AND DISSEMINATION: For this review, no ethical approval will be required because only data of studies in which informed consent was obtained will be considered and analysed. The final review manuscript will be published in an Open Access journal. To ensure effective promotion of this review project, we will disseminate major findings through relevant communication channels. PROSPERO REGISTRATION NUMBER: CRD42020184345.

Diabetes, employment and behavioural risk factors in China: Marginal structural models versus fixed effects models.

We use longitudinal data from the China Health and Nutrition Survey, covering the years 1997-2011, to estimate the effect of a diabetes diagnosis on an economic outcome (employment probabilities) and behavioural risk factors (alcohol consumption, smoking cessation, body mass index (BMI), physical activity and hypertension) for men and women. We apply two complementary statistical techniques-marginal structural models (MSMs) and fixed effects (FE) models-to deal with confounding. Both methods suggest, despite their different underlying assumptions, similar patterns that indicate important differences between men and women. Employment probabilities decline substantially after the diagnosis for women (-12.4 (MSM) and -15.5 (FE) percentage points), but do not change significantly for men. In particular, the MSM estimates indicate an increase in hypertension (13 percentage points) and a decrease in physical activity for women, while men have small and statistically insignificant changes in these outcomes. For BMI, the MSM results indicate statistically significant changes for men (-.76), but not for women, while the FE estimates show similar reductions for men and women (-.80 and -.73 respectively). Men also reduce their alcohol consumption, but do not cease to smoke. For women these risk factors have a prevalence close to zero to begin with, though women seem to still reduce alcohol consumption somewhat. These results suggest important gender differences in the impact of diabetes in China. To narrow these inequities policies supporting women to reduce diabetes related risk factors are likely important.

Using peer education to improve diabetes management and outcomes in a low-income setting: a randomized controlled trial.

BACKGROUND: Diabetes is an important health burden in Indonesia. However, diabetes management and treatment remain poor, with most people with diabetes in Indonesia not achieving the recommended blood glucose levels. Peer education may have particular potential in low-income settings in complementing diabetes care without being a large additional strain on the health system. METHODS/DESIGN: This cluster randomized controlled trial aims to identify the effect of the implementation of peer education for patients with type 2 diabetes on diabetes-related outcomes in Aceh, Indonesia, which will complement the diabetes treatment provided at primary-care health posts (puskesmas). Altogether, 29 puskesmas were recruited in Banda Aceh and Aceh Besar, each of which was randomly assigned to either the control or the intervention group. Then, 534 people with diabetes were identified and recruited through their respective puskesmas. The intervention consists of up to two peer education groups per puskesmas, which are led by previously trained people with diabetes. Peer education sessions are held every month for 18 months, with follow-up data being collected 9 and 18 months after the first peer education session. The main objective is to improve diabetes management and the health behavior of participants receiving peer education to reduce their average blood glucose levels as measured by glycated hemoglobin (HbA1c) levels. Secondary outcomes are the effects of peer education on lipid levels, waist circumference, blood pressure, quality of life, treatment adherence, diabetes knowledge, physical activity, and dietary diversity. Data sources for the measurement of outcomes include patient and health facility surveys and biomarker measurements. An economic evaluation will be conducted to assess the cost-effectiveness of the intervention. DISCUSSION: This trial will contribute to the evidence on the effectiveness and cost-effectiveness of peer education in improving diabetes management in a low-income setting in Indonesia and in other comparable contexts. TRIAL REGISTRATION: ISRCTN registry, ISRCTN68253014 . Registered on 18 February 2019.

The impact of diabetes on labour market outcomes in Mexico: A panel data and biomarker analysis.

Recent evidence for Mexico suggests important differences in health status between people with diagnosed and undiagnosed diabetes. However, there is at best scarce evidence on the economic consequences of diabetes, especially in contexts where the condition often remains undiagnosed, as is typically the case in low- and middle income countries. Using Mexican longitudinal and biomarker data we estimated the relationship between diabetes, as well as its time since diagnosis, and employment probabilities, wages and working hours. We further explored how these relationships differ for those with diagnosed and undiagnosed diabetes. For the longitudinal analyses, nationally representative data from 11995 men and 13858 women 15-64 years old were taken from three waves (2002, 2005, 2009) of the Mexican Family Life Survey. We estimated a fixed effects model to account for unmeasured time-invariant confounders of diabetes. We found a reduction in the probability of being employed of 7.7 and 6.3 percentage points for men and women, respectively, but no significant relationship with hours worked or wages. Employment probabilities fell gradually with each year since diagnosis for men but not for women. Using cross-sectional biomarker data, our results indicate that 68% of those exhibiting glycated hemoglobin (HbA1c) levels above the clinical diabetes threshold did not self-report a diagnosis, hence were undiagnosed. Nevertheless, regression analysis revealed that there was no association of diabetes with labour outcomes for undiagnosed women or men. This suggests that results based on self-reported diabetes cannot be extended to the (rather large) part of the population with undiagnosed diabetes, likely because of a selection of people in worse health and with a longer diabetes duration into the diagnosed population. Earlier diagnosis and improved treatment of diabetes therefore may prevent adverse health effects and related economic hardship.

Type 1 diabetes mellitus care and education in China: The 3C study of coverage, cost, and care in Beijing and Shantou.

AIMS: The paucity of data on Type 1 diabetes in China hinders progress in care and policy-making. This study compares Type 1 diabetes care and clinical outcomes in Beijing and Shantou with current clinical guidelines. METHODS: The 3C Study was a cross-sectional study of the clinical practices and outcomes of people with Type 1 diabetes. The study sequentially enrolled 849 participants from hospital records, inpatient wards, and outpatient clinics. Data were collected via face-to-face interviews with patients and health professionals, the Summary of Diabetes Self-Care Activities, medical records, and venous blood samples. Care was audited using ISPAD/IDF indicators. Data underwent descriptive analysis and tests for association. RESULTS: The median age was 22years (IQR=13-34years), and 48.4% of the sample had diabetes less than six years. The median HbA1c was 8.5% (69mmol/mol) (IQR 7.2-10.5%), with significant regional variance (p=0.002). Insulin treatment was predominantly two injections/day (45% of patients). The highest incidence of diabetic ketoacidosis was 14.4 events/100 patient years among adolescents. Of the 57.3% of patients with LDL-C>2.6mmol/L, only 11.2% received treatment. Of the 10.6% considered hypertensive, 47.1% received treatment. Rates of documented screening for retinopathy, nephropathy, and peripheral neuropathy were 35.2%, 42.3%, and 25.0%, respectively. The median number of days of self-monitoring/week was 3.0 (IQR=1.0-7.0). There were significant differences in care practices across regions. CONCLUSIONS: The study documented an overall deficit in care with significant regional differences noted compared to practice guidelines. Modifications to treatment modalities and the structure of care may improve outcomes.

IDF Diabetes Atlas estimates of 2014 global health expenditures on diabetes.

AIMS: To estimate health expenditures due to diabetes in 2014 for the world and its regions. METHODS: Diabetes-attributable health expenditures were estimated using an attributable fraction method. Data were sourced from International Diabetes Federation (IDF) estimates of diabetes prevalence, UN population projections, WHO annual health expenditure reports, and estimates of the cost ratio of people with and without diabetes. Health expenditures were calculated in both US dollars (USD) and international dollars (ID). RESULTS: The average health expenditure per person with diabetes worldwide in 2014 was estimated to range from USD 1583 (ID 1742) to USD 2842 (ID 3110). The estimated annual global health expenditure attributable to diabetes ranged from USD 612 billion (ID 673 billion) to USD 1099 billion (ID 1202 billion). Together, the North America and Caribbean Region and the Europe Region were responsible for over 69% of the costs, and less than 10% of the costs were from the Africa Region, South East Asia Region, and Middle East and North Africa Region combined. The North America and Caribbean Region had the highest annual spending per person with diabetes (USD 7984 [ID 8040.39]), while the South East Asia Region had the lowest annual spending per person with diabetes (USD 92 [ID 234]). CONCLUSIONS: Diabetes imposes a large economic burden on health care systems across the world, yet varies across world regions. Diabetes prevention and effective management of diabetes should be a public health priority to reduce the financial burden.

The impact of diabetes on employment in Mexico.

This study explores the impact of diabetes on employment in Mexico using data from the Mexican Family Life Survey (MxFLS) (2005), taking into account the possible endogeneity of diabetes via an instrumental variable estimation strategy. We find that diabetes significantly decreases employment probabilities for men by about 10 percentage points (p<0.01) and somewhat less so for women - 4.5 percentage points (p<0.1)--without any indication of diabetes being endogenous. Further analysis shows that diabetes mainly affects the employment probabilities of men and women above the age of 44 and also has stronger effects on the poor than on the rich, particularly for men. We also find some indication for more adverse effects of diabetes on those in the large informal labour market compared to those in formal employment. Our results highlight--for the first time--the detrimental employment impact of diabetes in a developing country.

The Economic Costs of Type 2 Diabetes: A Global Systematic Review.

BACKGROUND: There has been a widely documented and recognized increase in diabetes prevalence, not only in high-income countries (HICs) but also in low- and middle-income countries (LMICs), over recent decades. The economic burden associated with diabetes, especially in LMICs, is less clear. OBJECTIVE: We provide a systematic review of the global evidence on the costs of type 2 diabetes. Our review seeks to update and considerably expand the previous major review of the costs of diabetes by capturing the evidence on overall, direct and indirect costs of type 2 diabetes worldwide that has been published since 2001. In addition, we include a body of economic evidence that has hitherto been distinct from the cost-of-illness (COI) work, i.e. studies on the labour market impact of diabetes. METHODS: We searched PubMed, EMBASE, EconLit and IBSS (without language restrictions) for studies assessing the economic burden of type 2 diabetes published from January 2001 to October 2014. Costs reported in the included studies were converted to international dollars ($) adjusted for 2011 values. Alongside the narrative synthesis and methodological review of the studies, we conduct an exploratory linear regression analysis, examining the factors behind the considerable heterogeneity in existing cost estimates between and within countries. RESULTS: We identified 86 COI and 23 labour market studies. COI studies varied considerably both in methods and in cost estimates, with most studies not using a control group, though the use of either regression analysis or matching has increased. Direct costs were generally found to be higher than indirect costs. Direct costs ranged from $242 for a study on out-of-pocket expenditures in Mexico to $11,917 for a study on the cost of diabetes in the USA, while indirect costs ranged from $45 for Pakistan to $16,914 for the Bahamas. In LMICs-in stark contrast to HICs-a substantial part of the cost burden was attributed to patients via out-of-pocket treatment costs. Our regression analysis revealed that direct diabetes costs are closely and positively associated with a country's gross domestic product (GDP) per capita, and that the USA stood out as having particularly high costs, even after controlling for GDP per capita. Studies on the labour market impact of diabetes were almost exclusively confined to HICs and found strong adverse effects, particularly for male employment chances. Many of these studies also took into account the possible endogeneity of diabetes, which was not the case for COI studies. CONCLUSIONS: The reviewed studies indicate a large economic burden of diabetes, most directly affecting patients in LMICs. The magnitude of the cost estimates differs considerably between and within countries, calling for the contextualization of the study results. Scope remains large for adding to the evidence base on labour market effects of diabetes in LMICs. Further, there is a need for future COI studies to incorporate more advanced statistical methods in their analysis to account for possible biases in the estimated costs.