T1DM: Guideline and Systematic Review Methods (2024)
The methodology for this project was developed using the process of the Academy of Nutrition and Dietetics, in accordance with the Standards for Developing Clinical Practice Guidelines from the National Academy of Science using grading and guideline development tools from the GRADE (Grading of Recommendations Assessment, Development and Evaluation) group.
Overview of the Development Process
Evidence-based recommendations are the product of a rigorous and systematic, step-by-step process. These steps are listed briefly, and described in detail in the sections below.
- Conduct a scoping review to determine literature availability;
- Recruit and select an expert panel;
- Determine priorities, gaps in research, and, consequently, Population-Intervention-Comparison-Outcome (PICO)-formatted systematic review research questions to support recommendations;
- Develop a priori eligibility criteria for the systematic review;
- Design a search plan and register on the PROSPERO database;
- An information specialist conducts the search of databases;
- Titles and abstracts from database searches are screened and hand searched for relevant articles; review full-text articles for inclusion;
- Trained evidence analysts extract data using a standardized tool and assess quality (risk of bias) for each included article;
- Study characteristics and results are summarized in tabular form and evidence for each outcome is synthesized qualitatively (evidence summary and conclusion statement), quantitatively (in meta-analyses when possible) and in tabular form (study characteristics, intervention characteristics, and summary of findings tables) for each outcome reported in included studies. Conclusion statements are graded according to Academy and GRADE principles.
- Expert panel members complete GRADE’s evidence-to-decision (EtD) framework to determine the best recommendations based on evidence, clinical expertise and client values.
- Recommendations are rated according to Academy principles and voted on and approved by expert panel members;
- The evidence-based nutrition practice guideline was reviewed externally by nine individuals with content expertise using the AGREE II tool.
- Authors responded to reviewer comments and updated the guideline accordingly.
- EBNPG is approved by the Academy's Council on Research.
Supporting Systematic Review
To inform the development of the EBNPG, the Academy's Evidence Analysis Center (EAC) collaborated with the expert panel members to conduct a systematic review examining the effectiveness of nutrition management interventions on A1C in children and adolescents (6-19 years) living with T1DM. The development of systematic review followed methods from the Academy1 and Cochrane Collaborations GRADE method2, and adhered to Preferred Reporting Items for Systematic Reviews and Meta-Analysis checklist (PRISMA)3. The primary research question addressed in this systematic review was: In children and adolescents (6-19 years old) living with type 1 diabetes, what is the effect of nutrition interventions (macronutrient consumption, dietary patterns, diet quality, culturally relevant interventions, carbohydrate management strategies, food insecurity, vitamin D supplementation, Medical Nutrition therapy) compared to usual care on defined outcomes? A detailed list of questions that were deemed important for clinicians and patients is presented in Table 1. The expert panel also developed the a priori inclusion and exclusion criteria as listed in Table 2.
A comprehensive search of the literature was conducted by an information specialist using multiple databases (MEDLINE (Ovid), Embase (Ovid), PsycINFO (Ebsco), Cochrane CEDNTRAL (Ovid), Cochrane Database of Systematic Reviews (Ovid) and CINAHL (Ebsco)) for literature published between January 2000 and May 2021 in English language. The search included a combination of terms for T1DM pediatrics, lifestyle and dietary interventions, and RDNs for children and adolescents 6–19 years old. The complete search strategy can be found in the Type 1 Diabetes (Pediatrics) project on the EAL (www.andeal.org/t1dmp). A sample search from MEDLINE is provided in Table 3.
A total of twenty-six studies, 11 randomized controlled trials10-14, three non-randomized trials15-17, and 12 cohorts18-29 were included in the systematic review and analyzed to inform the EBNPG. Visit the EAL at www.andeal.org/t1dmp for a full description of the included and excluded studies (with reason for exclusion) and download the Study Characteristics tables for details of the included studies. All included studies were critically appraised for risk of bias using ROB 2.0 tool for randomized controlled trials, ROBINS-I for non-randomized trials, and the Academy’s Quality Criteria Checklist for cohort studies. Article screening and risk of bias assessment were conducted independently by two individuals and any differences were resolved by discussion with a third reviewer. The key findings of the systematic review indicate that: Overall, there was limited available evidence for most of the topics addressed; limited evidence reports that weekly medical nutrition therapy sessions for the first month after diagnosis and monthly sessions thereafter may reduce A1C; very low-quality evidence indicates that improvements in diet quality (HEI score) may be associated with better glycemic outcomes; the effects of dietary patterns like Mediterranean, DASH, and low glycemic index on glycemic outcomes are inconclusive; carbohydrate counting can be an effective strategy to help reduce and provide continued maintenance of A1C goals; very low-quality evidence indicates that culturally relevant/responsive nutrition intervention increases the ability to achieve improvements in A1C target and decrease the occurrence of adverse events; and very low-quality evidence indicates low socioeconomic status and lower maternal education are associated with poor glycemic outcomes and increased occurrence of adverse events, such as diabetic ketoacidosis, hospitalization, and emergency room calls and visits. Conclusion statements and grades for certainty (quality) of evidence from the systematic review can be found in Table 4.
Guideline Development Process
The expert panel and the guideline team used Academy methods30 and GRADE’s Evidence-to-Decision framework (EtD)31-32 to help translate available evidence into recommendation statements. The EtD framework guides expert panel members to use evidence in a structured and transparent manner to develop recommendation statements. It also guides them to consider the following factors along with evidence when drafting recommendations: balance of benefits and harms; evidence certainty; importance of affected outcomes; resource use; equity; client values; acceptability and feasibility to stakeholders and clinical expertise. Each potential recommendation statement and supporting text was drafted by one expert panel member using results from the systematic review interpreted through EtD framework. The results of the EtD survey and implications of those judgments were reviewed and edited by the methodologist and expert panel members. Multiple web calls were conducted to identify core concepts/ideas that needed to be included, with the work of the recommendation discussed at length. After much discussion and multiple rounds of editing to reach consensus, a recommendation statement was developed and accepted unanimously by the expert panel.
Grading of Recommendation Statements
Recommendation statements were graded with a number (1 or 2) and a letter (A-D).2 The number in the recommendation rating refers to the strength of the recommendation. The letter refers to the strength of evidence from the supporting systematic review (HIGH-A, MODERATE-B, LOW-C or VERY LOW-D).2 Typically, higher certainty evidence resulted in strong recommendations and lower certainty evidence resulted in weak recommendations. However, in some cases, evidence was limited, but expert panel members came to a consensus that a recommendation should be rated as strong due to clinical experience. In cases where evidence was unavailable or unclear, recommendations were graded as “Consensus” and were based on relevant literature, scope of practice, and clinical expertise (Tables 5-6).
External Review and Stakeholder Involvement
The systematic reviews were conducted and the EBNPG was developed by an expert panel of volunteer Academy members who were selected by the Work Group Selection Subcommittee of the Academy’s Council on Research following a transparent process of selecting an expert workgroup panel of subject-matter experts. Additionally, two of the expert panel members also served as patient advocates to provide perspectives of individuals living with T1DM. The members of the expert panel participated in all steps of the systematic review process and guideline development process. The completed EBNPG underwent a peer review. External reviewers working in the field of diabetes and specifically with the pediatric population were recruited to conduct an in-depth review of all recommendations and supporting information. The Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool33 will be provided as an assessment tool for rigor of the guideline’s development process and an opportunity to provide feedback on the content of the guideline. The EBNPG was also reviewed by a representative from the Academy’s Inclusion, Diversity, Equity and Access (IDEA) Committee. Finally, a consumer-facing guide will be developed and shared with practitioners and other stakeholders for usability testing and input. Comments from external reviewers will be collated by the guideline development team and sent to the expert panel for discussion and editorial consideration. The expert panel chair coordinated the final revision of the EBNPG document based on review comments.
The authors also consulted the literature for qualitative or quantitative studies that examined perspectives of children and adolescents regarding management of T1DM. Findings from these studies informed recommendations and implementation consideration.
Guideline Updates
Academy guidelines are considered for update every five years. In five years, a scoping review will be conducted to determine whether substantial literature on the topic has been published since the past systematic review. The Academy’s Council on Research, informed by the research team, based on the findings of the scoping review determines whether this guideline requires modification to none, some, or all recommendation statements.
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