- 2021;24;S1-S26Methodology for Evidence Synthesis and Development of Comprehensive Evidence-Based Guidelines for Interventional Techniques in Chronic Spinal Pain
Health Services Research
Laxmaiah Manchikanti, MD, Sairam Atluri, MD, Mark V. Boswell, MD, PhD, Aaron K. Calodney, MD, Sudhir Diwan, MD, Sanjeeva Gupta, MD, Alan D. Kaye, MD, PhD, Nebojsa Nick Knezevic, MD, PhD, Kenneth D. Candido, MD, Alaa Abd-Elsayed, MD, Miguel A. Pappolla, MD, Gabor B. Racz, MD, Harsh Sachdeva, MD, Mahendra R. Sanapati, MD, Shalini Shah, MD, Vanila Singh, MD, Amol Soin, MD, and Joshua A. Hirsch, MD.
BACKGROUND: The re-engineered definition of clinical guidelines in 2011 from the IOM (Institute of Medicine) states, “clinical practice guidelines are statements that include recommendations intended to optimize patient care that is informed by a systematic review of evidence and an assessment of the benefit and harms of alternative care options.” The revised definition distinguishes between the term “clinical practice guideline” and other forms of clinical guidance derived from widely disparate development processes, such as consensus statements, expert advice, and appropriate use criteria.
OBJECTIVE: To assess the literature and develop methodology for evidence synthesis and development of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain.
METHODS: A systematic review of the literature including methodology of guideline development encompassing GRADE approach for guidance on evidence synthesis with recommendations.
RESULTS: Some of the many factors described in 2011 continue as of 2020 and impede the development of clinical practice guidelines. These impediments include biases due to a variety of conflicts and confluence of interest, inappropriate and poor methodological quality, poor writing and ambiguous presentation, projecting a view that these are not applicable to individual patients or too restrictive with the elimination of clinician autonomy, and overzealous and inappropriate recommendations, either positive, negative, or non-committal. Thus, ideally, a knowledgeable, multidisciplinary panel of experts with true lack of bias and confluence of interest must develop guidelines based on a systematic review of the existing evidence.
This manuscript describes evidence synthesis from observational studies, various types of randomized controlled trials (RCTs), and, finally, methodological and reporting quality of systematic reviews. The manuscript also describes various methods utilized in the assessment of the quality of observational studies, diagnostic accuracy studies, RCTs, and systematic reviews.
LIMITATIONS: Paucity of publications with appropriate evidence synthesis methodology in reference to interventional techniques.
CONCLUSION: This review described comprehensive evidence synthesis derived from systematic reviews, including methodologic quality and bias measurement. The manuscript described various methods utilized in the assessment of the quality of the systematic reviews, RCTs, diagnostic accuracy studies, and observational studies.
KEY WORDS: Evidence-based medicine (EBM), interventional pain management, evidence synthesis, methodological quality assessment, conflict of interest, confluence of interest, comparative effectiveness research (CER), clinical practice guidelines, systematic reviews, meta-analysis