Methods & Criteria 

EVIDENCE

Professional Practice Committee (PPC)

  • Comprised of multidisciplinary experts responsible for the Standards of Care.
  • Experts from various fields including adult and pediatric endocrinology, epidemiology, public health, and more.

Disclosure and Duality of Interest Management

  • All committee members disclose potential conflicts of interest.
  • A duality of interest review group evaluates these disclosures to manage potential conflicts.

Evidence Review

  • Systematic literature searches are performed, focusing on relevant clinical questions.
  • Searches are conducted in PubMed Medline and EMBASE for specified time periods.
  • Subcommittee members manually search journals, conference proceedings, and regulatory agency websites.
  • Evidence summaries are prepared based on the literature review.

Grading of Evidence and Recommendation Development

  • Evidence is graded using an ADA-developed system, with recommendations receiving ratings of A, B, C, or E based on the quality of evidence.
  • All recommendations are critical to comprehensive care regardless of their rating.

Revision Process

  • The Standards of Care undergo a public comment period for feedback.
  • Feedback from external peer reviewers is considered.
  • The Standards of Care is approved by the ADA Board of Directors and undergoes external peer review annually.

Acknowledgments and External Peer Review

  • External peer reviewers from various specialties contribute to the review process.
  • The document also acknowledges the input from specific subject matter experts and ADA staff.

PubMed, Medline, and EMBASE searches from 1 June 2021 to 26 July 2022, along with manual searches of journals, conference proceedings, and regulatory agency websites.

The guideline references 115 studies and trials!

High Internal Validity:  The study design, conduct, and analysis minimizes biases or confounding variables, allowing for confident conclusions.

High External Validity: The study’s conclusions are relevant and applicable to broader scenarios beyond the specific conditions of the study.

 

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Peer-Reviewed

  • ADA's Professional Practice Committee serves a role similar to peer review for the Standards of Care.

  • This committee, composed of multidisciplinary diabetes experts, rigorously evaluates the latest research and clinical data to update the guidelines.

  • Their expertise and the process they follow ensure the recommendations are evidence-based and reflect current best practices in diabetes care.

Quality of Evidence

  • A: High-quality evidence from well-conducted, generalizable randomized controlled trials or meta-analyses.

  • B: Supportive evidence from well-conducted cohort studies, case-control studies, or meta-analyses of these studies.

  • C: Evidence from poorly controlled or uncontrolled studies, including case series, case reports, or expert opinion.

  • E: Expert consensus or clinical experience when evidence is lacking or not available.
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Methodology

  • Literature Review: The ADA Professional Practice Committee conducts a comprehensive review of the current medical literature, including research studies, clinical trials, and other relevant publications.

  • Evidence Grading: The evidence is graded based on its quality, relevance, and the strength of its findings. This grading system helps in prioritizing the recommendations.

  • Expert Consensus: Committee members discuss the evidence and come to a consensus on the recommendations. This process involves considering the balance of benefits and risks, patient preferences, and clinical feasibility.

  • Drafting Guidelines: The committee drafts the guidelines based on this evidence and consensus.

  • External Review: The draft guidelines are then reviewed by external experts and stakeholders for further input and validation.

  • Publication and Updates: Once finalized, the guidelines are published and made available to healthcare providers. They are updated annually or more frequently if significant new evidence becomes available.

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Benefits & Risks

  • Health Benefits: Detailed recommendations on interventions known or believed to favorably affect health outcomes of people with diabetes. This encompasses prevention, screening, diagnosis, and management strategies for diabetes and its associated complications and comorbidities.

  • Side Effects and Risks: Guidance on managing complications and the side effects of diabetes treatments, including pharmacologic therapies. The document emphasizes a personalized approach, taking into account individual patient factors such as comorbidities, which may affect the risk-benefit assessment of specific interventions.
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Potential Bias

  • Treatment Recommendations Bias: Preferences for certain therapies based on clinical trial sponsors or research focus.

  • Cost Consideration Bias: Preference for medications based on their cost, potentially overlooking individual patient needs or medication efficacy.

  • Clinical Trial Population Bias: Clinical trials may not fully represent the broader diabetes population, affecting the applicability of results.

  • Innovation Bias: A focus on newer treatments over established ones, driven by novelty rather than comparative effectiveness.

  • Publication Bias: More likely publication of positive findings over negative ones, skewing the understanding of a treatment's effectiveness.

  • Guideline Bias: Biases in how evidence is interpreted in clinical guidelines, influenced by expert opinions and consensus.

  • Accessibility and Availability Bias: Not fully accounting for patient access issues like insurance coverage and healthcare system barriers.

  • Preference Bias: Treatment choices influenced by patient or provider preferences, perceptions, and past experiences.

Strengths:

  1. Comprehensive Evidence Base: Integrates findings from over 100 studies, ensuring recommendations are grounded in a wide array of research.
  2. Multidisciplinary Expertise: Developed by a committee of experts from various fields, ensuring diverse perspectives on diabetes care.

Weaknesses:

  1. Generalization: Guidelines may not address specific individual patient needs due to their broad scope.
  2. Rapidly Evolving Field: The fast pace of new research in diabetes care may outdate some recommendations before the next scheduled update.
View 2024 Guidelines