self-management education) or have been conducted in specific populations. : 18-05239-EF-1. Sample sizes for cluster RCTs were adjusted to account for the design effect using the intracluster correlation coefficient (ICC) [22]. Difference in change-from-baseline HbA 1c…, Figure A1:. (E) high-income countries; LMICs, Non-glycemic outcomes of mortality, health-related quality of life, and cost-effectiveness were less frequently reported. Formal analysis, Health system interventions can help address this priority. Difference in change-from-baseline HbA 1c values between behavioural interventions and usual care control…, Figure A3:. The trim-and-fill method was also applied to impute the number of studies potentially missing from the meta-analysis and to re-estimate an overall effect size accounting for publication bias [27]. Non-glycemic outcomes of mortality, health-related quality of life, and cost-effectiveness had sparse data availability that precluded quantitative pooling. Most included studies were conducted in upper-middle-income countries, and few studies were carried out in rural areas or low- or lower-middle-income countries. We did not assess blood pressure outcomes given our primary interest in the evidence of interventions attempting to achieve glycemic control and prior meta-analyses supporting the effectiveness of health system interventions for blood pressure control [74,81]. We followed the methodology recommended in the Cochrane handbook to calculate within-group mean and standard deviation when this information was not directly reported in the study or made available by authors [22]. Those are chlopropamide, glyburide, glipizide. Patients were recruited from several settings: six studies from primary or general medical practices, three studies from the community (e.g. Study selection. No, Is the Subject Area "Quality of life" applicable to this article? Despite differences in individual needs to cope with diabetes, there is general agreement for the necessity of supportive programs for patient self-management. If you need help injecting yourself, Emma can show you how in our video below. Only the health literacy intervention arm was included in the study by Wang and colleagues [54]. Difference in change-from-baseline HbA1c values…, Figure A3:. Patnode CD, Evans CV, Senger CA, Redmond N, Lin JS. Our findings imply a need for implementation research to investigate the details of health system interventions that confer durable improvements in clinical and patient-centered outcomes in LMICs, especially in rural areas and in low- and lower-middle-income countries. RCTs are not the only form of evidence generation in the field of health policy and research [77], and diverse research strategies are needed in conditions like type 2 diabetes that have a strong clinical evidence base yet weak evidence on implementation [3,78]. In the overall meta-analysis of HbA1c from 35 trials, we found that health system interventions modestly improved glycemic control on average. Difference in change-from-baseline HbA1c values between behavioural interventions and usual care control for…, Figure A7:. Nutrition interventions for type 2 diabetes Recommendations. Prior reviews of task shifting for chronic diseases in LMICs have identified few trials in type 2 diabetes [72,73]. Home telemonitoring for type 2 diabetes: an evidence-based analysis. low- and middle-income countries; RCT, In order to provide comprehensive pathway of weight management support for those at risk and with type 2 diabetes, we recommend adopting a tiered approach to weight management programmes which relates to the level of risk for an individual. Individuals with type 2 diabetes are encouraged to implement lifestyle modifications that reduce intakes of energy, saturated and trans fatty acids, cholesterol, and sodium and to increase physical activity in an effort to improve glycemia, dyslipidemia, and blood pressure. Data Availability: The study’s dataset and statistical code are available through Dataverse at: https://doi.org/10.7910/DVN/NIESKT. The oral medications are-Sulfonylureas: which stimulates release of insulin from pancreatic islets, reduce blood glucose. The intensity of interventions was incompletely reported but ranged from 3 to 16 telephone calls or face-to-face visits. Resources, Outcomes of interest were of challenging behaviour, well being, clinical and process. A descriptive analysis of study characteristics and evaluation criteria are pre- sented. Focus 3 – Results of the Objective Examinations and Test Results Ont Health Technol Assess Ser. Group counselling was used in five studies as a mode of instruction, three studies used both individual and group sessions, and one study used individual sessions as its sole mode of instruction. If you have type 2 diabetes, you may be able to control your symptoms simply by eating a healthy diet, and monitoring your blood glucose level. Incorporating heterogeneous study designs, these previous reviews have surveyed the limited evidence and described various approaches that have been implemented in LMICs. Around 95% of all people with diabetes have type 2 diabetes. Patterns of Glycemic Variability During a Diabetes Self-Management Educational Program. Distinct from task shifting, task sharing emphasizes the shared responsibility for a task between the health workers’ different levels and types of training [71]. The only outcome in our review for which a meta-analysis was conducted, HbA1c, is only a surrogate outcome, but it is commonly used in meta-analyses of systems-level interventions for diabetes [7,9]. Defining a health system intervention is challenging, and there is no consensus definition. Logistical challenges in conducting randomized studies within health systems likely explain why we identified few interventions testing financial or governance arrangements. • The study by Mash et al. The search strategy was built in English, and no language filters were applied. Ob An advantage of including only RCTs is that we are able to offer robust evidence of the impact of health system interventions on glycemic control and reveal the limited data on other outcomes. Yes For example, an intervention training healthcare professionals on diabetes education was included; however, an intervention aiming to improve outcomes solely through individualized diabetes education was excluded [14]. doi: 10.2196/18922. Data from the United Kingdom Prospective Diabetes Study (UKPDS) has shown that tight glycemic control can significantly reduce the risk of developing serious complications in type 2 diabetics. Of the estimated 463 million adults worldwide with type 2 diabetes, approximately 80% reside in LMICs [1]. STUDY CHARACTERISTICS: The studies were conducted between 2002 and 2008. 2003). Writing – review & editing, Affiliation Databases were chosen to be inclusive of international and interdisciplinary literature. Examples of health system interventions include quality and safety programs, health information systems, health worker incentives, and changes in scope of practice [5]. Glycemic changes were reported based on HbA1c values in 36 studies and based on fasting glucose alone in 3 trials. In the trial conducted by Tutino and colleagues in China, both the intervention and comparator arms included implementation of a web-based clinical information portal, and the intervention arm received additional nurse-led care coordination [52]. Task sharing also was a fundamental component in the nurse-led intervention by Fairall and colleagues in South Africa [29], a nurse care coordination trial [52], and multicomponent clinic-based studies [31,58,59]. A dramatic example of this effect was the Happy Life Club trial in China, in which both trial arms experienced 3.7% within-group HbA1c improvement over 18 months [32]. Difference in change-from-baseline HbA 1c…, Figure A5:. Within subgroups of intervention type, mean HbA1c difference was −0.37% (95% CI −0.64% to −0.10%, I2 60.0% [95% CI 8.2% to 82.6%], n = 7) in multicomponent clinic-based interventions, −0.87% (95% CI −1.20% to −0.53%, I2 91.0% [95% CI 86.5% to 94.0%], n = 13) in pharmacist task-sharing studies, and −0.27% (95% CI −0.50% to −0.04%, I2 64.1% [95% CI 18.8% to 84.1%], n = 7) in trials of diabetes education or support alone. Rockville (MD): Agency for Healthcare Research and Quality (US); 2018 Sep. Report No. Our review should be considered in the context of the movement to strengthen health systems in LMICs [75]. In this meta-analysis, we found that health system interventions for type 2 diabetes may be effective in improving glycemic control in LMICs, but few studies are available from rural areas or low- or lower-middle-income countries. We excluded non-randomized study designs given the challenge in attributing causality for outcomes and inconsistent reporting of these designs in pilot searches. Medizin Typ-2-Diabetes: Intensive Lebensstil-Inter­vention kann Medikamente ersetzen Mittwoch, 16. Our review was supplemented with unpublished data received from multiple study authors, and we were able to pool HbA1c statistical estimates reported differently across studies. Despite physicians' and patients' knowledge of the importance of glycemic control, Canadian data has shown that only 38% of patients with diabetes have HbA1C levels in the optimal range of 7% or less. To present the most common quality criteria in health promotion interventions in type 2 diabetes mellitus (T2DM). We investigated the experience of individuals diagnosed with type 2 diabetes mellitus (T2DM) who participated in an intervention in which the key elements were the provision of a smartphone and self-monitoring software. Conceptualization, Data curation, Division of General Internal Medicine, Department of Medicine, University of Minnesota, Minneapolis, Minnesota, United States of America, If you have type 2 diabetes, you may be able to control your symptoms simply by eating a healthy diet, and monitoring your blood glucose level. Other components in the bundles included health record establishment [61], electronic decision support [31,58], physician education [30,59,60,62,63], care coordination or case management [58,62], clinical information systems [30,60,62,63], and clinical audit and feedback [62,63]. Formal analysis, (2)Faculty Practice & Community Engagement, West Virginia University, Morgantown, WV, 26506, USA. The health workers in these studies varied between and within studies and included peers [49,53,56], community health workers [43,46,53], nurses [32,39,40,53,54], psychologists [32], and physicians [32,39,54]. Finally, although there were substantial similarities within intervention types, individual studies varied by setting and population, limiting our ability to make conclusions with high degrees of certainty. One author (DF) extracted summary data into a customized electronic spreadsheet, and 2 other authors (JH and MD) independently verified the extracted data. Heterogeneity was explored by calculating I2 and T2, and we report 95% confidence intervals for I2 if 3 or more studies are pooled [26]. INTERVENTION CHARACTERISTICS: All of the interventions examined in the studies were mapped to the 2007 Self-management Mapping Guide. At the same time, multiple well-conducted trials had null results [30,31,62]. Further studies in LMICs are needed to assess non-glycemic outcomes and, given the wide prediction intervals, to determine the specific components and details of health system interventions most likely to promote effectiveness and limit potential harms. Type 2 diabetes accounts for 90-95% of diabetes and while type 2 diabetes is more prevalent in people aged 40 years and older, prevalence in younger populations is increasing due to a rise in obesity and physical inactivity in children. Effectiveness of Internet-Based Multicomponent Interventions for Patients and Health Care Professionals to Improve Clinical Outcomes in Type 2 Diabetes Evaluated Through the INDICA Study: Multiarm Cluster Randomized Controlled Trial. LeBlanc EL, Patnode CD, Webber EM, Redmond N, Rushkin M, O’Connor EA. Despite the homogeneity in the aims of the interventions, there was substantial clinical heterogeneity in other intervention characteristics such as duration, intensity, setting, mode of delivery (group vs. individual), interventionist, and outcomes of interest (discussed below). The proportion of participants from low- and middle-income countries was inferred to be 60% in the study by Reutens and colleagues [66]. The direct health care cost of diabetes was $1.76 billion in the year 2000 and is projected to rise to a total cost of $3.14 billion by 2016. Project administration, Yes We conducted a systematic review and meta-analysis of 39 health system interventions aiming to improve outcomes of glycemic (i.e., blood glucose) control, mortality, quality of life, or cost-effectiveness for people with type 2 diabetes in LMICs. Yes The overall HbA1c prediction interval was −1.19% to 0.28%. We used the EPOC review group’s definition of health system interventions as those designed to “improve the professional practice and the delivery of effective health services” through changes in healthcare delivery, financing, governance, and implementation [5,14]. Community-based care for the management of type 2 diabetes: an evidence-based analysis. COVID-19 is an emerging, rapidly evolving situation. Our review was restricted to studies with at least 6 months of follow-up and 100 enrolled participants. Ont Health Technol Assess Ser. Two health system interventions involved physician clinical training alone [65,66]. The absence of high-quality trials resulted in a low certainty of evidence for pharmacist task-sharing studies despite their sizeable pooled HbA1c estimate in the meta-analysis. To our knowledge, no review has systematically assessed evidence from randomized controlled trials (RCTs) or conducted a meta-analysis. Twenty-nine studies were conducted in upper-middle-income countries as defined by the World Bank, and only 1 trial included a site in a low-income country. Writing – review & editing, Affiliation We inferred an ICC from the literature if one was not reported in the study or its trial protocol [23]. Further research is needed to assess other outcomes beyond glycemic control, especially in rural areas and in low- or lower-middle-income countries. Ont Health Technol Assess Ser. In conclusion, we found that health system interventions for type 2 diabetes may be effective in improving glycemic control in LMICs, but few studies were available from rural areas or low- or lower-middle-income countries. Three studies were based on the Chronic Care Model [60,62,63]. Everyone with Type 1 diabetes, and some people with Type 2 diabetes, need to take insulin to control their blood glucose (sugar) levels. Difference in change-from-baseline HbA 1c…, Figure A2:. Randomized designs in health system research have limitations, including the possible attenuation of effect sizes [80]. Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan United States of America, Methodology, However, in those with type 2 diabetes, the degree of glycaemic control and type and dose of diabetes medication should be coordinated with dietary intake.12 With some dietary interventions, such as very low calorie or low carbohydrate diets, people with diabetes would usually stop or reduce their diabetes medication and be monitored closely, as reviewed in a later section. Eight trials were classified as clinic-based multicomponent interventions, which we defined as studies involving multiple types of health workers implementing a bundle of quality improvement or health system strengthening interventions [30,31,58–63]. First, we excluded studies with high risk of bias. Division of Hospital Medicine, Department of Medicine, University of Michigan, Ann Arbor, Michigan United States of America. Difference in change-from-baseline HbA 1c…, Figure A9:. One study was classified as an mHealth screening and quality improvement intervention [64]. Joshi A, Mitra A, Anjum N, Shrivastava N, Khadanga S, Pakhare A, Joshi R. Med Sci (Basel). In LMICs, prior reviews draw from diverse study designs and together suggest a modest yet increasing number of studies on the implementation of evidence-based type 2 diabetes care into health systems in LMICs [11–13]. We conducted 2 sensitivity analyses. eCollection 2018 Dec. Diabetes Spectr. August 2017 PLOS Medicine publishes research and commentary of general interest with clear implications for patient care, public policy or clinical research agendas. No, Is the Subject Area "Randomized controlled trials" applicable to this article? Effective health system interventions are needed to implement type 2 diabetes care in settings with different resources, cultures, and population risk factors [6]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Visualization, Prevention of type 2 diabetes in relatives and partners of people with the condition is under researched. GRADE and Cochrane Effective Practice and Organisation of Care methods were used to assess risk of bias for the glycemic outcome and to prepare a summary of findings table. The most common intervention types we identified were multicomponent clinic-based interventions, pharmacist task-sharing interventions, and interventions of diabetes education or support alone. The mean age of participants reported was approximately 58 years and the mean duration of diabetes was approximately 6 years. Cost-effectiveness was reported as an incremental cost-effectiveness ratio (ICER) in 5 studies. Difference in change-from-baseline HbA 1c values between behavioural interventions and usual care control…, NLM Two authors (DF and JH) independently screened studies by title and abstract and, subsequently, by full-text review. If outcomes were missing or not reported, we contacted authors twice to obtain data. Two studies described the comparator group as enhanced usual care, where the enhancement consisted of clinical training for health professionals [30,31], and in 1 study the medical fees were waived in the comparator arm [32]. Writing – review & editing, Affiliations https://www.gov.uk/.../health-matters-preventing-type-2-diabetes Task sharing was a common thread across intervention types. Another consideration is that research trial infrastructure in resource-limited settings may catalyze the delivery of standard clinical care across trial arms. Most studies incorporated primary care doctors in a team-based intervention [30,31,59,60,62,63], and the study by Ali and colleagues incorporated endocrinologists [58]. Randomised controlled trials with a pre-test/post-test design that evaluated a diabetes self-management programme compared with no intervention in adults (at least 18 years) with type 2 diabetes were eligible for inclusion. : 15-05222-EF-1. Background: systolic blood pressure (SBP) control, lipid control, change in smoking status, weight change, quality of life, knowledge, self-efficacy, managing psychosocial aspects of diabetes, assessing dissatisfaction and readiness to change, and setting and achieving diabetes goals. Software, At the same time, the wide prediction interval overlapping 0 in the meta-analysis of HbA1c showed that there was a wide range of effectiveness across studies, and some health system interventions may not be effective in all settings. Of the eleven studies, two focused only on women and four included only Hispanic individuals.  |  We describe outcomes of glycemic change, mortality, quality of life, and cost-effectiveness by study in S5 Appendix. Effective health system interventions may help address the disproportionate burden of diabetes in low- and middle-income countries (LMICs). There is thus much uncertainty regarding the optimal design and delivery of these programs by policymakers. Carpenter R(1), DiChiacchio T(2), Barker K(1). This intervention is based on a medium-range nursing theory of individual and family self-management. JMIR Mhealth Uhealth. Methodology, 2009;9(24):1-38. Both individual and group sessions were used to deliver interventions. Project administration, Data on population characteristics, glycemic control outcomes, and study design were extracted. Appropriate management of lifestyle can effectively prevent the development of diabetes mellitus. 2018 Nov 27;17(2):365-380. doi: 10.1007/s40200-018-0376-0. Psychobehavioural model of variables influencing self-management and clinical outcome in diabetes, Figure 2:. . Approximately six of 11 studies were carried out within the USA, with the remaining studies conducted in the UK, Sweden, and Israel (sample size ranged from 47 to 824 participants). A 2012 meta-analysis of 142 randomized trials primarily conducted in HICs found that interventions targeting the health system rather than healthcare providers or patients alone were most effective [9].  |  Of the 11 studies reporting quality of life, 6 studies reported no significant differences between the intervention and comparator arms [29,32,45,46,52,59], and 5 studies showed improved quality of life in the intervention arm [33,40,51,58,62]. Our findings support the scaling up of diabetes health system interventions to improve patients’ glycemic control in LMICs. Our review complements prior meta-analyses of studies primarily from HICs showing the benefit of systems-level quality improvement interventions on surrogate outcomes such as HbA1c, blood pressure, and cholesterol [7–9]. Other types of interventions had few included studies. One study was classified as a nurse task-sharing intervention [29]. Funding: DF is supported by the National Clinician Scholars Program at the University of Michigan Institute for Healthcare Policy & Innovation. Studies are listed in the figure by first author [28–36,38–42, 44–55,57–60,62–66]. Clinical and process CV, Senger CA, Redmond N, Lin JS made available under the Creative Commons public... Inclusive of international and interdisciplinary literature key focus areas when managing type 2 Adult populations! 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Have type 2 Adult diabetic populations: an evidence-based analysis education, but health systems in LMICs have difficulty diabetes. Increase physical activity alone overall pooled analysis that was partially explained by intervention type and HbA1c. Countries on diabetes guidelines using 2 in-person sessions and reminders [ 66 ] clear implications for patient,. 65,66 ] another study [ 40 ] ( 11 ): Agency for Healthcare policy & Innovation professional ” to. We observed differences across studies: a systematic literature search was conducted to identify review articles, health system for. Arms [ 33,59 ] is limited outcomes such as type of health system interventions to improve in! Outcomes such as type of health system interventions to improve patients ’ glycemic control,!, Brown SJ, Wagenaar BH, Rogers EA, et al [ 52 ] or health. Of ongoing projects funded by the local Program or setting of care care, etc. ) have! ( ICER ) in 5 trials, oral medications are-Sulfonylureas: which stimulates release of insulin pancreatic...
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