Scooping Review of Diabetes Research in Kenya from 2000 to 2020.

Background: The prevalence of diabetes is on the rise globally, with likely disproportionate increase in Sub-Saharan Africa. In Kenya, diabetes has been acknowledged as one of the top non-communicable diseases needing prevention and control. Research can contribute to diabetes prevention and control: however, the landscape of diabetes research in Kenya remains understudied. Methods: PubMed, MEDLINE, Scopus, PsycINFO, CINAHL, Google Scholar and ProQuest were searched for relevant articles. We included studies on humans, reporting on any type of diabetes, conducted in Kenya between 2000 to 2020. Results: From the search, 983 records were retrieved out of which 102 met the study inclusion criteria. Most studies were facility based (71%) cross sectional (65%) and descriptive (71%) conducted in Nairobi (38%) between 2013-2020 (82%), focused on diabetes control, (71%) and funded by organisations/institutions from high income countries (73%). Conclusion: Despite the recent increase in research outputs, there is still limited diabetes research being conducted in Kenya necessitating more research in the country and particularly outside Nairobi to inform prevention and control efforts. Specifically, more focus should be given to etiological and intervention studies (which use longitudinal and randomised controlled trial designs), community-based and public health research. Finally, increased local funding for diabetes research is required.

Sample size in multistakeholder Delphi surveys: at what minimum sample size do replicability of results stabilize?

BACKGROUND AND OBJECTIVE: The minimum sample size for multistakeholder Delphi surveys remains understudied. Drawing from three large international multistakeholder Delphi surveys, this study aimed to: 1) investigate the effect of increasing sample size on replicability of results; 2) assess whether the level of replicability of results differed with participant characteristics: for example, gender, age, and profession. METHODS: We used data from Delphi surveys to develop guidance for improved reporting of health-care intervention trials: SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) extension for surrogate end points (n = 175, 22 items rated); CONSORT-SPI [CONSORT extension for Social and Psychological Interventions] (n = 333, 77 items rated); and core outcome set for burn care (n = 553, 88 items rated). Resampling with replacement was used to draw random subsamples from the participant data set in each of the three surveys. For each subsample, the median value of all rated survey items was calculated and compared to the medians from the full participant data set. The median number (and interquartile range) of medians replicated was used to calculate the percentage replicability (and variability). High replicability was defined as ≥80% and moderate as 60% and <80% RESULTS: The average median replicability (variability) as a percentage of total number of items rated from the three datasets was 81% (10%) at a sample size of 60. In one of the datasets (CONSORT-SPI), a ≥80% replicability was reached at a sample size of 80. On average, increasing the sample size from 80 to 160 increased the replicability of results by a further 3% and reduced variability by 1%. For subgroup analysis based on participant characteristics (eg, gender, age, professional role), using resampled samples of 20 to 100 showed that a sample size of 20 to 30 resulted to moderate replicability levels of 64% to 77%. CONCLUSION: We found that a minimum sample size of 60-80 participants in multistakeholder Delphi surveys provides a high level of replicability (≥80%) in the results. For Delphi studies limited to individual stakeholder groups (such as researchers, clinicians, patients), a sample size of 20 to 30 per group may be sufficient.

Knowledge, perceptions and practices towards diabetes risk in sub-Saharan Africa: a mixed-methods scoping review.

OBJECTIVE: To synthesise current evidence on knowledge, perceptions and practices towards type 2 diabetes risk in sub-Saharan Africa. DESIGN: Mixed-methods scoping review, which included 101 studies (seventy-three quantitative, twenty qualitative and eight mixed methods) from seven electronic databases. SETTING: Sub-Saharan Africa, 2000-2023. PARTICIPANTS: Men and women without diabetes with mean ages ranging from 20 to 63 years. RESULTS: The majority of participants in most studies knew the three main diabetes modifiable risk factors - excess weight, unhealthy diet and physical inactivity. However, most people with excess weight in almost all studies underestimated their weight. Further, the self-described ideal body weight was between midpoint of normal weight and the upper limits of overweight in most quantitative studies and was described as not too skinny but not too fat in qualitative studies. In the majority of studies, participants reported low engagement in weight control, high regular sugar intake, and low regular fruit and vegetable intake but moderate to high engagement in physical activity. Barriers to reducing diabetes risk were social (e.g. societal perceptions promoting weight gain) and environmental (e.g. limited affordability of healthy foods, high accessibility of Western diets and lack of physical activity facilities). CONCLUSION: There is a need for multicomponent type 2 diabetes prevention interventions that increase knowledge of identifying diabetes risk (e.g. what constitutes excess weight) and create social and physical environments that support healthy lifestyles (e.g. societal perceptions that promote healthy living, increased availability and affordability of healthy foods and physical activity facilities).

Perceptions of diabetes risk and prevention in Nairobi, Kenya: A qualitative and theory of change development study.

BACKGROUND: Type 2 diabetes is increasing in Kenya, especially in urban settings, and prevention interventions based on local evidence and context are urgently needed. Therefore, this study aimed to explore diabetes risk and co-create a diabetes prevention theory of change in two socioeconomically distinct communities to inform future diabetes prevention interventions. METHODS: In-depth interviews were conducted with middle-aged residents in two communities in Nairobi (one low-income (n = 15), one middle-income (n = 14)), and thematically analysed. The theory of change for diabetes prevention was informed by analysis of the in-depth interviews and the Behaviour Change Wheel framework, and reviewed by a sub-set (n = 13) of interviewees. RESULTS: The key factors that influenced diabetes preventive practices in both communities included knowledge and skills for diabetes prevention, understanding of the benefits/consequences of (un)healthy lifestyle, social influences (e.g., upbringing, societal perceptions), and environmental contexts (e.g., access to (un)healthy foods and physical activity facilities). The proposed strategies for diabetes prevention included: increasing knowledge and understanding about diabetes risk and preventive measures particularly in the low-income community; supporting lifestyle modification (e.g., upskilling, goal setting, action planning) in both communities; identifying people at high risk of diabetes through screening in both communities; and creating social and physical environments for lifestyle modification (e.g., positive social influences on healthy living, access to healthy foods and physical activity infrastructure) particularly in the low-income community. Residents from both communities agreed that the strategies were broadly feasible for diabetes prevention but proposed the addition of door-to-door campaigns and community theatre for health education. However, residents from the low-income community were concerned about the lack of government prioritisation for implementing population-level interventions, e.g., improving access to healthy foods and physical activity facilities/infrastructure. CONCLUSION: Diabetes prevention initiatives in Kenya should involve multicomponent interventions for lifestyle modification including increasing education and upskilling at individual level; promoting social and physical environments that support healthy living at population level; and are particularly needed in low-income communities.

Definitions, acceptability, limitations, and guidance in the use and reporting of surrogate end points in trials: a scoping review.

OBJECTIVE: To synthesize the current literature on the use of surrogate end points, including definitions, acceptability, and limitations of surrogate end points and guidance for their design/reporting, into trial reporting items. STUDY DESIGN AND SETTING: Literature was identified through searching bibliographic databases (until March 1, 2022) and gray literature sources (until May 27, 2022). Data were thematically analyzed into four categories: (1) definitions, (2) acceptability, (3) limitations and challenges, and (4) guidance, and synthesized into reporting guidance items. RESULTS: After screening, 90 documents were included: 79% (n = 71) had data on definitions, 77% (n = 69) on acceptability, 72% (n = 65) on limitations and challenges, and 61% (n = 55) on guidance. Data were synthesized into 17 potential trial reporting items: explicit statements on the use of surrogate end point(s) and justification for their use (items 1-6); methodological considerations, including whether sample size calculations were informed by surrogate validity (items 7-9); reporting of results for composite outcomes containing a surrogate end point (item 10); discussion and interpretation of findings (items 11-14); plans for confirmatory studies, collecting data on the surrogate end point and target outcome, and data sharing (items 15-16); and informing trial participants about using surrogate end points (item 17). CONCLUSION: The review identified and synthesized items on the use of surrogate end points in trials; these will inform the development of the Standard Protocol Items: Recommendations for Interventional Trials-SURROGATE and Consolidated Standards of Reporting Trials-SURROGATE extensions.

Protocol for the development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: SPIRIT-SURROGATE and CONSORT-SURROGATE.

INTRODUCTION: Randomised controlled trials (RCTs) may use surrogate endpoints as substitutes and predictors of patient-relevant/participant-relevant final outcomes (eg, survival, health-related quality of life). Translation of effects measured on a surrogate endpoint into health benefits for patients/participants is dependent on the validity of the surrogate; hence, more accurate and transparent reporting on surrogate endpoints is needed to limit misleading interpretation of trial findings. However, there is currently no explicit guidance for the reporting of such trials. Therefore, we aim to develop extensions to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines to improve the design and completeness of reporting of RCTs and their protocols using a surrogate endpoint as a primary outcome. METHODS AND ANALYSIS: The project will have four phases: phase 1 (literature reviews) to identify candidate reporting items to be rated in a Delphi study; phase 2 (Delphi study) to rate the importance of items identified in phase 1 and receive suggestions for additional items; phase 3 (consensus meeting) to agree on final set of items for inclusion in the extensions and phase 4 (knowledge translation) to engage stakeholders and disseminate the project outputs through various strategies including peer-reviewed publications. Patient and public involvement will be embedded into all project phases. ETHICS AND DISSEMINATION: The study has received ethical approval from the University of Glasgow College of Medical, Veterinary and Life Sciences Ethics Committee (project no: 200210051). The findings will be published in open-access peer-reviewed publications and presented in conferences, meetings and relevant forums.

Scoping and targeted reviews to support development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: protocol.

INTRODUCTION: Using a surrogate endpoint as a substitute for a primary patient-relevant outcome enables randomised controlled trials (RCTs) to be conducted more efficiently, that is, with shorter time, smaller sample size and lower cost. However, there is currently no consensus-driven guideline for the reporting of RCTs using a surrogate endpoint as a primary outcome; therefore, we seek to develop SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) extensions to improve the design and reporting of these trials. As an initial step, scoping and targeted reviews will identify potential items for inclusion in the extensions and participants to contribute to a Delphi consensus process. METHODS AND ANALYSIS: The scoping review will search and include literature reporting on the current understanding, limitations and guidance on using surrogate endpoints in trials. Relevant literature will be identified through: (1) bibliographic databases; (2) grey literature; (3) handsearching of reference lists and (4) solicitation from experts. Data from eligible records will be thematically analysed into potential items for inclusion in extensions. The targeted review will search for RCT reports and protocols published from 2017 to 2021 in six high impact general medical journals. Trial corresponding author contacts will be listed as potential participants for the Delphi exercise. ETHICS AND DISSEMINATION: Ethical approval is not required. The reviews will support the development of SPIRIT and CONSORT extensions for reporting surrogate primary endpoints (surrogate endpoint as the primary outcome). The findings will be published in open-access publications.This review has been prospectively registered in the OSF Registration DOI: 10.17605/OSF.IO/WP3QH.

Optimal cut-offs of five anthropometric indices and their predictive ability of type 2 diabetes in a nationally representative Kenyan study.

BACKGROUND: Type 2 diabetes (T2D) is one of the top non-communicable diseases in Kenya and prevention strategies are urgently needed. Intervening to reduce obesity is the most common prevention strategy. However, black populations develop T2D at lower obesity levels and it is unclear which anthropometric cut-offs could provide the best predictive ability for T2D risk. This study, therefore, aimed to determine the optimal anthropometric cut-offs and their predictive ability of T2D in Kenya. METHODS: The study included 2159 participants (59% women) aged 35-70 years from the Kenya STEPwise survey conducted in 2014. Five anthropometric indices were used-body mass index (BMI), waist circumference (WC), waist to hip ratio (WHR), waist to height ratio (WHtR) and waist divided by height0.5(WHt.5R). Diabetes was defined as a fasting blood glucose of ≥7.0 mmol/l or a previous diagnosis by a health worker. Optimal anthropometric cut-offs and their receiver operating characteristics, such as the area under the curve (AUC), were computed. RESULTS: Overall, the optimal cut-off for BMI, WC, WHR, WHtR and WHt.5R were 24.8 kg.m-2, 90 cm, 0.88, 0.54 and 6.9. On disaggregation by sex, the optimal cut-off for BMI, WC, WHR WHtR and WHt.5R was 27.1 kg.m-2, 87 cm, 0.85, 0.55 and 6.9 in women, and 24.8 kg.m-2, 91 cm, 0.88, 0.54 and 6.9 in men. Overall, WC (AUC 0.71 (95% confidence interval 0.65, 0.76)) WHtR (AUC 0.71 (0.66, 0.76)) and WHt.5R (AUC 0.70 (0.65,0.75)) had a better predictive ability for T2D than BMI (AUC 0.68 (0.62, 0.73)). CONCLUSIONS: WC, WHtR and WHt.5R were better predictors of T2D than BMI and should be used for risk stratification in Kenya. A WC cut-off of 87cm in women and 91cm in men, a WHtR cut-off of 0.54 or a WHt.5R of 6.9 in both men and women should be used to identify individuals at an elevated risk of T2D.

Comparison of risk factors between people with type 2 diabetes and matched controls in Nairobi, Kenya.

OBJECTIVE: To identify risk factors associated with type 2 diabetes (T2D) in Nairobi, Kenya. METHODS: A case-control study comparing 70 (53% women) recently diagnosed T2D cases with age-, sex- and socioeconomic status-matched normoglycemic controls (1:1). Objectively measured data were obtained on anthropometrics, handgrip strength and physical activity (by accelerometer). Self-reported data were collected on demographic characteristics and lifestyle factors. Logistic regression models, adjusted for covariates, were used to analyse the data. RESULTS: Each standard deviation (SD) increase in height was associated with lower odds for T2D (adjusted odds ratio (AOR) = 0.34 (95% confidence intervals [CIs] 0.17, 0.66), P = 0.0031). Fat-free mass was inversely associated with T2D (AOR = 0.42 (95% CI 0.24, 0.75), P = 0.0032, per SD increase). Grip strength was associated with a lower risk of T2D (AOR = 0.20 (95% CI 0.08, 0.45), P < 0.001, per SD increase). BMI was not associated with T2D, but higher waist-to-hip ratio was associated higher odds of T2D (AOR = 2.28 (95% CI 1.38, 3.79), P = 0.0014, per SD increase). Physical activity was not associated with T2D. Cases reported higher intakes of fruits and vegetables and a lower intake of sugar than controls. CONCLUSIONS: Central obesity, rather than BMI, may have more utility for T2D risk stratification in Kenya, and interventions that increase muscle mass and strength, as well as support weight loss, may be useful for T2D prevention in this and other SSA populations. However, more evidence is needed to determine whether low muscle mass, strength and height are causally related to T2D risk and/or are indicators of adverse early-life environment.