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Methodologic Innovation in Creating Clinical Practice Guidelines

Insights From the 2018 Society of Critical Care Medicine Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption Guideline Effort

Devlin, John W., PharmD, FCCM1,2; Skrobik, Yoanna, MD, FRCP(c), MSc, FCCM3,4,5; Rochwerg, Bram, MD, MSc6,7; Nunnally, Mark E., MD, FCCM8,9,10,11; Needham, Dale M., MD, PhD12; Gelinas, Celine, RN, PhD13; Pandharipande, Pratik P., MD, MSCI, FCCM14; Slooter, Arjen J. C., MD, PhD15; Watson, Paula L., MD16; Weinhouse, Gerald L., MD17; Kho, Michelle E., PT, PhD18; Centofanti, John, MD, MSc19; Price, Carrie, MLS20; Harmon, Lori, RRT, MBA21; Misak, Cheryl J., PhD22; Flood, Pamela D., MD23; Alhazzani, Waleed, MD, MSc7,24

doi: 10.1097/CCM.0000000000003298
Clinical Investigations
Editor's Choice

Objectives: To describe novel guideline development strategies created and implemented as part of the Society of Critical Care Medicine’s 2018 clinical practice guidelines for pain, agitation (sedation), delirium, immobility (rehabilitation/mobility), and sleep (disruption) in critically ill adults.

Design: We involved critical illness survivors from start to finish, used and expanded upon Grading of Recommendations, Assessment, Development and Evaluation methodology for making recommendations, identified evidence gaps, and developed communication strategies to mitigate challenges.

Setting/Subjects: Thirty-two experts from five countries, across five topic-specific sections; four methodologists, two medical librarians, four critical illness survivors, and two Society of Critical Care Medicine support staff.

Interventions: Unique approaches included the following: 1) critical illness survivor involvement to help ensure patient-centered questions and recommendations; 2) qualitative and semiquantitative approaches for developing descriptive statements; 3) operationalizing a three-step approach to generating final recommendations; and 4) systematic identification of evidence gaps.

Measurements and Main Results: Critical illness survivors contributed to prioritizing topics, questions, and outcomes, evidence interpretation, recommendation formulation, and article review to ensure that their values and preferences were considered in the guidelines. Qualitative and semiquantitative approaches supported formulating descriptive statements using comprehensive literature reviews, summaries, and large-group discussion. Experts (including the methodologists and guideline chairs) developed and refined guideline recommendations through monthly topic-specific section conference calls. Recommendations were precirculated to all members, presented to, and vetted by, most members at a live meeting. Final electronic voting provided links to all forest plots, evidence summaries, and “evidence to decision” frameworks. Written comments during voting captured dissenting views and were integrated into evidence to decision frameworks and the guideline article. Evidence gaps, reflecting clinical uncertainty in the literature, were identified during the evidence to decision process, live meeting, and voting and formally incorporated into all written recommendation rationales. Frequent scheduled “check-ins” mitigated communication gaps.

Conclusions: Our multifaceted, interdisciplinary approach and novel methodologic strategies can help inform the development of future critical care clinical practice guidelines.

1School of Pharmacy, Northeastern University, Boston, MA.

2Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center, Boston, MA.

3Faculty of Medicine, McGill University, Montreal, QC, Canada.

4Regroupement de Soins Critiques Respiratoires, Réseau de Santé Respiratoire, Montreal, QC, Canada.

5Faculty of Medicine, Queen’s University, Kingston, ON, Canada.

6Department of Medicine (Critical Care), McMaster University, Hamilton, ON, Canada.

7Department of Health Research Methods, Impact and Evidence, McMaster University, Hamilton, ON, Canada.

8Division of Anesthesiology, Perioperative Care and Pain Medicine, New York University Langone Health, New York, NY.

9Division of Medicine, New York University Langone Health, New York, NY.

10Division of Neurology, New York University Langone Health, New York, NY.

11Division of Surgery, New York University Langone Health, New York, NY.

12Division of Pulmonary and Critical Care Medicine, Department of Physical Medicine and Rehabilitation, School of Medicine, Johns Hopkins University, Baltimore, MD.

13Ingram School of Nursing, McGill University, Montreal, QC, Canada.

14Department of Anesthesiology, Division of Anesthesiology Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN.

15Department of Intensive Care Medicine, Brain Center Rudolf Magnus, University Medical Center, Utrecht University, Utrecht, The Netherlands.

16Division of Sleep Medicine, Vanderbilt University Medical Center, Nashville, TN.

17Division of Pulmonary and Critical Care, Brigham and Women’s Hospital and School of Medicine, Harvard University, Boston, MA.

18School of Rehabilitation Science, McMaster University, Hamilton, ON, Canada.

19Department of Anesthesia and Critical Care, McMaster University, Hamilton, ON, Canada.

20Welch Medical Library, Johns Hopkins University, Baltimore, MD.

21Society of Critical Care Medicine, Mount Prospect, IL.

22Department of Philosophy, University of Toronto, Toronto, CA.

23Division of Anesthesiology, Stanford University Hospital, Palo Alto, CA.

24Department of Medicine (Critical Care and Gastroenterology), McMaster University, Hamilton, ON, Canada.

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Dr. Devlin has received research funding from the National Institute of Aging, National Heart, Lung and Blood Institute, and AstraZeneca Pharmaceuticals, is on the editorial board of Critical Care Medicine, and is the president of the American Delirium Society. Dr. Skrobik participates in the American Thoracic Society (ATS) and the American College of Chest Physicians, and she is on the editorial board for Intensive Care Medicine and Chest. Dr. Rochwerg participates as a guideline methodologist for other organizations (i.e., ATS and Canadian Blood Service) in addition to Society of Critical Care Medicine. Dr. Nunnally participates in the Society of Critical Care Anesthesiologists, International Anesthesia Research Society, and American Society of Anesthesiology (ASA). Dr. Needham is a principal investigator on a National Institutes of Health (NIH)-funded, multicentered randomized trial (R01HL132887) evaluating nutrition and exercise in acute respiratory failure and, related to this trial, is currently in receipt of an unrestricted research grant and donated amino acid product from Baxter Healthcare and an equipment loan from Reck Medical Devices to two of the participating study sites, external to his institution. Dr. Pandharipande’s institution received funding from Hospira (research grant to purchase study drug [dexmedetomidine] in collaboration with a NIH-funded RO1 study) and disclosed that he is the past president of the American Delirium Society. Dr. Slooter has disclosed that he is involved in the development of an electroencephalography-based delirium monitor, where any (future) profits from electroencephalography-based delirium monitoring will be used for future scientific research only. Dr. Kho received funding from Restorative Therapies (Baltimore, MD) (loaned two supine cycle ergometers for ongoing research). Ms. Price has disclosed that she is a medical librarian working at Johns Hopkins University, and she consults as an information specialist to the Cochrane Urology Review Group. Dr. Flood participates on the Society of Obstetric Anesthesia and Perinatology research committee and the ASA Chronic Pain Committee. The remaining authors have disclosed that they do not have any potential conflicts of interest.

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