VLBW: Guideline Methods and Stakeholders (2020)
Evidence-based Nutrition Practice Guidelines (EBNPGs) and their supporting systematic reviews (SR) are developed by a multidisciplinary team, with oversight by the Academy of Nutrition and Dietetics Council on Research. The multidisciplinary team includes a volunteer expert panel, a project manager, lead analyst, medical librarian, several analysts, and Academy staff experts in systematic review methodology. The expert panel is composed of health practitioners (RDs, PharmD, and MDs), researchers, and a patient advocate with extensive experience working with the population of interest. The expert panel represents the views and concerns of the target population throughout the development of the SR and EBNPG.
The Preterm Guideline is a result of a two-phase multi-organizational collaborative effort started by the National Institute of Health and the Academy of Nutrition and Dietetics. The first phase sought to identify the current state of evidence, and the needs and perspectives of stakeholders. A steering committee consisting of members from organizations including but not limited to the American Academy of Pediatrics, the American Society for Nutrition, and the American Society for Parenteral and Enteral Nutrition was established. For additional information regarding Phase I please see:
- Raiten DJ, Steiber AL, Carlson SE, et al. Working group reports: evaluation of the evidence to support practice guidelines for nutritional care of preterm infants-the Pre-B Project. Am J Clin Nutr. 2016;103(2):648S-678S.
- Raiten DJ, Steiber AL, Hand RK. Executive summary: evaluation of the evidence to support practice guidelines for nutritional care of preterm infants-the Pre-B Project. Am J Clin Nutr. 2016;103(2):599S-605S.
The Academy of Nutrition and Dietetics led Phase II of the Pre-B process which included scoping, conducting systematic reviews, and developing recommendations.
Expert Panel Description and Selection Process
In 2016, expert panel members were recruited from Phase I participants. Applicants were reviewed by the Academy’s Evidence Based Practice Committee (now represented on the Academy’s Council on Research) and six applicants were selected. A chair was appointed from this group of selected individuals. Additionally, one patient advocate was recruited from Consumers United for Evidence-based Healthcare (CUE). This organization provides expertise in recruiting and training patient advocates. The expert panel participated in each step of the systematic review and guideline development process. The patient advocate reviewed materials and provided final review the guideline prior to publication. Academy staff and contractors supporting the workgroup included systematic review and guideline methodologists, a medical librarian, project manager, lead analysts, and trained evidence analysts. The workgroup met in a virtual workspace approximately 1-2 times per month to develop research questions, screen studies, analyze evidence, vote on, and grade conclusion statements, and develop, discuss and rate recommendations.
The preterm expert panel convened to review and prioritize subtopics and questions proposed from Phase I. Due to the broad scope of content from Phase I, the expert panel conducted a scoping review. For additional information please see:
- Moloney L, Rozga M, Fenton TR. Nutrition Assessment, Exposures, and Interventions for Very-Low-Birth-Weight Preterm Infants: A Scoping Review. J Acad Nutr Diet. 2018.
The scoping review identified that the National Institute for Health and Care Excellence (NICE) was in the process of developing Neonatal Parenteral Nutrition guidelines for several patient populations which included preterm infants, therefore, the expert panel decided to focus systematic reviews on enteral nutrition. After thorough review of articles identified in the scoping review, and deliberation amongst the expert panel, additional criteria was established. Due to heterogeneity in neonatal practice amongst nations, the preterm workgroup decided to limit studies to those conducted in developed nations. Furthermore, the workgroup decided to focus the guideline on the most vulnerable preterm infants, those born less than or equal to 1, 500 grams [which are referred to as very low birthweight (VLBW) infants].
Overview of the Guideline Development Process
After the scoping review and prioritization of topics the expert panel followed the rigorous guideline development process:
- Develop PICO-formatted systematic review research questions to support recommendations;
- Develop a priori eligibility criteria for the systematic review;
- Design search plan and register on PROSPERO database;
- Medical Librarian conducts search of databases;
- Titles and abstracts from database search were screened and hand searched for relevant articles; Review full-text articles for inclusion;
- Trained evidence analysts extracted data using a standardized tool and assess quality (risk of bias) for each included article;
- Study characteristics and results were summarized in tabular form and evidence for each outcome was synthesized qualitatively (evidence summary and conclusion statement) and in tabular form (summary of findings table) for each outcome reported in included studies. Conclusion statements were graded according to Academy and GRADE principles.
- When evidence was available, workgroup members complete the GRADE’s evidence-to-decision (EtD) framework to determine best recommendations based on evidence, clinical expertise, and patient values.
- Recommendations were rated according to Academy principles and voted on and approved by workgroup members.
- Evidence-based practice guideline was reviewed externally by individuals with content expertise using the AGREE II tool;
- Responded to reviewer comments and update publication.
Systematic Review Process
Question Development, Literature Search and Study Selection
This guideline followed the Academy of Nutrition and Dietetics systematic review methodology.1 During the initial teleconference calls, the workgroup developed a list of questions that were deemed important for clinicians and patients. The workgroup developed the a priori inclusion and exclusion criteria. The expert panel priotized the top seven outcomes of interest: Mortality/survival Morbidity; Growth; Anthropometrics; Development; Gastrointestinal health; Bone Mineral Content; and Protein Utilization. The PICO questions and search plan for this systematic review were registered a priori on the PROSPERO database (CRD42018086829).3
A medical librarian using PubMed, Embase, CINAHL and Cochrane Central databases to identify eligible studies published from January 1980 until the search date of November 2017. Another search was conducted using PubMed to identify eligible human milk studies in November 2018. The search was conducted to identify a range of enteral nutrition topics to inform development of an evidence-based nutrition practice guideline examining enteral feeding interventions and exposures for VLBW infants with a birthweight ≤1500g. Relevant systematic reviews were also hand searched for eligible studies. Details regarding the number of results, includes, and excludes can be found under each research question. After the search was completed, results were uploaded onto Abstrktr.2 Studies were systematically screened based additional a priori inclusion/exclusion criteria.
Data Extraction and Study Quality Assessment
Data was extracted from the included articles using the Academy’s Data Extraction Tool. Extracted data included: Authors; year of publication; study design; inclusion/exclusion criteria; intervention or exposure, sample size, outcomes, and time points of reported outcomes.
All included studies were critically appraised for risk of bias. Two independent reviewers assessed the quality or studies using the Academy’s online risk of bias tool, the Quality Criteria Checklist (QCC).3 The questions of the QCC were based on quality constructs and risk of bias domains identified by the Cochrane Collaboration and the Agency for Healthcare Research ad Quality (AHRQ).4 Questions examine selection bias, performance bias, detection bias, attrition bias, and reporting bias. Any discrepancies between the two reviewers were resolved by consensus or by a third reviewer.
Data Synthesis and Grading the Evidence
Narrative synthesis was conducted for each outcome that had available data, meta-analysis was conducted when possible. A study characteristics table provided information regarding study characteristics, sample size, population, intervention details and quality of each included study. A conclusion statement was developed for each proposed question/outcome and graded. A Summary of Findings table was generated using GradePro and demonstrated how the strength of evidence (GRADE) was derived for each outcome.5 A conclusion statement was drafted and graded using the GRADE table.
This guideline followed the Academy’s Evidence Analysis Center’s process for guideline development.6 For each nutrition topic investigated for which evidence was available the expert panel completed GRADE’s Evidence-to-Decision framework, which guides review of the balance of benefits and harms, certainty of evidence, outcome importance, resource use, equity, patient values, acceptability and feasibility based on available evidence and clinical expertise in order to develop recommendations.7 Each recommendation was rated via the Academy method for rating recommendations based on strength of evidence/confidence in findings and clinical experience. The expert panel discussed the recommendations and rating until consensus was reached.
External Peer Review Process
This guideline underwent a systematic peer review process. The AGREE II tool (Appraisal of Guidelines for Research and Evaluation) criteria were used to assess the quality of guideline reporting. Reviewer comments were collated by staff and sent to the expert panel for discussion and possible edits.
1. Handu D, Moloney L, Wolfram T, Ziegler P, Acosta A, Steiber A. Academy of Nutrition and Dietetics Methodology for Conducting Systematic Reviews for the Evidence Analysis Library. J Acad Nutr Diet. 2016;116(2):311-318.
2. Rathbone J, Hoffmann T, Glasziou P. Faster title and abstract screening? Evaluating Abstrackr, a semi-automated online screening program for systematic reviewers. Syst Rev. 2015;4(80).
3. Academy of Nutrition and Dietetics Evidence Analysis Library. Evidence Analysis Manual: Steps in the Academy Evidence Analysis Process: a Systematic Review and Guideline Manual https://www.andeal.org/evidence-analysis-manual. Published 2016. Accessed.
4. Guyatt G, Oxman AD, Akl EA, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol. 2011;64(4):383-394.
5. McMaster University, (developed by Evidence Prime I. GRADEpro GDT: GRADEpro Guideline Development Tool [Software]. gradepro.org. Published 2015. Accessed.
6. Papoutsakis C, Moloney L, Sinley RC, Acosta A, Handu D, Steiber AL. Academy of Nutrition and Dietetics Methodology for Developing Evidence-Based Nutrition Practice Guidelines. J Acad Nutr Diet. 2017;117(5):794-804.
7. Moberg J, Oxman AD, Rosenbaum S, et al. The GRADE Evidence to Decision (EtD) framework for health system and public health decisions. Health Res Policy Syst. 2018;16(1):45.
For a full description of the EAL systematic review and guideline development process, see the Policy and Process tab in the main navigation bar at the top of the page.
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