Guideline Development and Committees

Guideline Development and Committees

Expert Committees

Composition: The Clinical Guidelines Program works directly with committees composed of experts in the field who represent multiple disciplines (medicine, nursing, psychology, pharmacy, public health, social work, mental health), clinical specialties (infectious diseases, family medicine, obstetrics and gynecology, hepatology, pediatrics, psychiatry, dentistry, prevention, etc.), and various geographic regions of New York State.

A Clinical Guidelines Program Steering Committee provides oversight and strategy to the following Clinical Guidelines Program committees, each of which is responsible for developing and updating clinical practice guidelines that fall under its area of expertise. Current committees (February 2020) include the following:

Financial disclosure and confidentiality agreement: All potential and active committee members are required to sign a confidentiality agreement and to disclose annually all financial relationships with commercial entities or gifts that may be actual, potential, or perceived as conflicts of interest. Committee members must report financial relationships with commercial entities that have existed in the 12 months prior to or are expected to exist in the 12 months after the date on which they sign their disclosure form.

Guideline development process: When the Clinical Guidelines Program identifies the need to develop or update a guideline, the committee under whose purview the guideline falls convenes to determine the goals of the guideline and its content, review the published literature, and weigh new evidence for recommendations. Text is then drafted by an author who has experience with the topic of the guideline. The guideline draft is edited by the team at JHU, and then reviewed and modified by the committee. This rigorous development process may entail multiple rounds of review, revision, rating, and editing. Decision-making occurs by consensus, and all guideline recommendations are reviewed by and receive the consensus approval of the full guideline committee. 

Evidence-based Recommendations: All recommendations are rated to reflect the strength of each recommendation and the quality of the supporting evidence. Ratings are reached through review of the evidence and consensus decision. If the published evidence in support of a particular recommendation is not sufficient, the group relies on collective best practices experience to develop a final statement. The rating scheme for recommendations appears below.

AIDS Institute Clinical Guidelines Program: Recommendations Ratings
(updated June 2019 [a])
Strength of Recommendation Ratings
A Strong recommendation
B Moderate recommendation
C Optional
Quality of Supporting Evidence Ratings
1 Evidence is derived from published results of at least one randomized trial with clinical outcomes or validated laboratory endpoints.
* Evidence is strong because it is based on a self-evident conclusion(s); conclusive, published, in vitro data; or well-established practice that cannot be tested because ethics would preclude a clinical trial.
2 Evidence is derived from published results of at least one well-designed, nonrandomized clinical trial or  observational cohort study with long-term clinical outcomes.
2† Evidence has been extrapolated from published results of well-designed studies (including non-randomized clinical trials) conducted in populations other than those specifically addressed by a recommendation. The source(s) of the extrapolated evidence and the rationale for the extrapolation are provided in the guideline text. One example would be results of studies conducted predominantly in a subpopulation (e.g., one gender) that the committee determines to be generalizable to the population under consideration in the guideline.
3 Recommendation is based on the expert opinion of the committee members, with rationale provided in the guideline text.
  1. With the June 2019 update, the ratings for quality of supporting evidence were expanded to add the * rating and the 2† rating.

External review: All guidelines are reviewed by external experts in the field and by the AIDS Institute’s Consumer Advisory Committee. 

Final approval: The guideline is submitted to the AIDS Institute for review and final approval prior to publication. The AI may request additional review by other agencies and organizations when applicable.

Guideline Updates: Members of guideline committees monitor developments ongoing to maintain guideline currency, at regular intervals. Newly published data that provides support for existing recommendations will be cited in the text and the studies will be added to the reference list. If newly published data prompts a revision to recommendations or rationale, a planning committee proposes appropriate edits and determines whether any changes warrant full committee review and approval. 

Medical Care Criteria Committee (MCCC; Adult HIV Treatment and Prevention)

Updated July 2020 | Recent changes to the MCCC

Leadership

Chair: Joseph P. McGowan, MD, FACP, FIDSA
North Shore University Hospital, Manhasset, NY
No disclosures

Vice-Chair: Steven M. Fine, MD, PhD
University of Rochester Medical Center, Rochester, NY
No disclosures

Chair Emeritus: Samuel T. Merrick, MD
New York Presbyterian Hospital-Weill Cornell Medical Center, New York, NY
No disclosures

Medical Director: Charles J. Gonzalez, MD
New York State Department of Health, AIDS Institute, New York, NY
No disclosures

Deputy Medical Director: Lyn C. Stevens, MS, NP, ACRN
New York State Department of Health AIDS Institute, Albany, NY
No disclosures

JHU Principal Investigator: Christopher J. Hoffmann, MD, MPH
Johns Hopkins University School of Medicine, Division of Infectious Diseases, Baltimore, MD
No disclosures

Contributing Members

Jessica M. Atrio, MD, MSc
Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY
No disclosures

Oni J. Blackstock, MD, MHS
NYC Health + Hopsitals/Harlem, New York, NY
No disclosures

James C. M. Brust, MD
Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY
No disclosures

John M. Conry, PharmD, AAHIVP, FNAP
St. John’s University, Queens, NY
No disclosures

Ethan A. Cowan, MD, MS
Icahn School of Medicine at Mount Sinai, New York, NY
No disclosures

Elliot DeHaan, MD
New York Presbyterian Hospital-Weill Cornell Medical Center, New York, NY
No disclosures

Mary Dyer, MD
Hudson River Healthcare, Monticello, NY
No disclosures

Annette Gaudino, Community Advisor
Treatment Action Group (TAG), New York, NY
No disclosures

Jeremiah Johnson, Community Advisor
Treatment Action Group (TAG), New York, NY
No disclosures

Christine A. Kerr, MD
Galileo Health
No disclosures

Jeremy D. Kidd, MD, MPH
New York Presbyterian Hospital, Columbia University, New York, NY
No disclosures

Gene Morse, PharmD, FCCP, BCPS
University at Buffalo School of Pharmacy & Pharmaceutical Sciences, Buffalo, NY
No disclosures

Hector Ojeda-Martinez, MD
Health Quest Medical Practice, Poughkeepsie, NY
No disclosures 

Asa E. Radix, MD, MPH, FACP, AAHIVS
Callen-Lorde Community Health Center, New York, NY
No disclosures

Sanjiv S. Shah, MD, MPH, AAHIVM, AAHIVS
MetroPlus Health Plan, New York, NY
No disclosures

Noga Shalev, MD
Columbia University Medical Center, New York, NY
No disclosures

Eugenia L. Siegler, MD
Weill Cornell Medical College, New York, NY
No disclosures

Maria Teresa (Tess) Timoney, MS, RN, CNM
Bronx Lebanon Hospital Center, Bronx, NY
No disclosures

Marguerite A. Urban, MD
University of Rochester School of Medicine and Dentistry, Rochester, NY
No disclosures

Antonio E. Urbina, MD 
The Mount Sinai Hospital, Comprehensive Health Program-Downtown, New York, NY
Scientific Advisor: Gilead, ViiV, Merck

Rona M. Vail, MD
Callen-Lorde Community Health Center, New York, NY
No disclosures

Geoffrey A. Weinberg, MD
University of Rochester School of Medicine and Dentistry, Rochester, NY
No disclosures

Recent Changes to the MCCC

July 2020

Joined the MCCC: Ethan A. Cowan, MD, MS, Icahn School of Medicine at Mount Sinai

Stepped down from the MCCC: Daniel J. Egan, MD, Columbia University Vagelos College of Physicians and Surgeons

January 2020

Joined the MCCC: Jessica M. Atrio, MD, MSc, Albert Einstein College of Medicine/Montefiore Medical Center; Oni Blackstock, MD, MHS, New York City Department of Health and Mental Hygiene

Stepped down from the MCCC: Julie E. Myers, MD, MPH, New York City Department of Health and Mental Hygiene

December 2019

Stepped down from the MCCC: Jack Fuhrer, MD, Stony Brook University School of Medicine; Luz Amarilis Lugo, MD, Mount Sinai Comprehensive Health Program-Downtown; Cynthia H. Miller, MD, Albany Medical Center; David C. Perlman, MD, Icahn School of Medicine at Mount Sinai

Hepatitis C Virus (HCV) Guideline Committee

Updated February 2020 | Recent changes to the HCV Guideline Committee

Leadership

Chair: Joshua S. Aron, MD
Elmhurst Hospital Center, Elmhurst, NY
No disclosures

Vice-Chair: Ponni V. Perumalswami, MD
Icahn School of Medicine at Mount Sinai, New York, NY
No disclosures

Chair Emerita: Christine A. Kerr, MD
Galileo Health
No disclosures

Medical Director: Charles J. Gonzalez, MD
New York State Department of Health AIDS Institute, New York, NY
No disclosures

Deputy Medical Director: Lyn C. Stevens, MS, NP, ACRN
New York State Department of Health AIDS Institute, Albany, NY
No disclosures

JHU Principal Investigator: Christopher J. Hoffmann, MD, MPH
Johns Hopkins University School of Medicine, Division of Infectious Diseases, Baltimore, MD
No disclosures

AIDS Institute Clinical Representative, Viral Hepatitis: Colleen Flanigan, RN, MS
New York State Department of Health AIDS Institute, Albany, NY
No disclosures

Contributing Members 

Mary Angerame, MS APN-BC
Jordan Health, Rochester, NY
No disclosures

Ayse Aytaman, MD, AGAF, FACG
Veterans Affairs New York Harbor Healthcare System, Brooklyn, NY
No disclosures

David Bernstein, MD, FAASLD, FACG, AGAF, FACP
Hofstra-Northwell School of Medicine, Manhasset, NY
Scientific Advisor: Abbvie, Gilead

Annette Gaudino, Community Advisor
Treatment Action Group (TAG), New York, NY
No disclosures

Kristen Marks, MD
Weill Cornell Medical College, New York, NY
No disclosures

Brianna Norton, DO, MPH
Montefiore Medical Group, Bronx, NY
No disclosures

Jeffrey J. Weiss, PhD, MS
Mount Sinai School of Medicine, New York, NY
No disclosures

Recent Changes to the HCV Guideline Committee

February 2020

Appointed Vice-Chair: Ponni V. Perumalswami, MD, Icahn School of Medicine at Mount Sinai

Stepped down as Vice-Chair; appointed Chair Emerita: Christine A. Kerr, MD, Galileo Health 

Perinatal Transmission Prevention Guideline Committee

Updated February 2020

Leadership

Chair: Marc Foca, MD
Children’s Hospital at Montefiore Albert Einstein College of Medicine, Bronx, NY
No disclosures

Chair Emeritus: Rodney L. Wright, MD, MS
Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY
No disclosures

Chair Emeritus: Murli Purswani, MBChB, FAAP
Bronx-Lebanon Hospital Center, Bronx, NY
No disclosures

Medical Director: Charles J. Gonzalez, MD
New York State Department of Health AIDS Institute, New York, NY
No disclosures

Deputy Medical Director: Lyn C. Stevens, MS, NP, ACRN
New York State Department of Health AIDS Institute, Albany, NY
No disclosures

JHU Principal Investigator: Christopher J. Hoffmann, MD, MPH
Johns Hopkins University School of Medicine, Division of Infectious Diseases, Baltimore, MD
No disclosures

AIDS Institute Clinical Representative, Perinatal HIV Prevention: Suzanne Kaufman, MPH, BSN, AACRN
New York State Department of Health AIDS Institute, Albany, NY
No disclosures

Contributing Members

Helene Bernstein, MD, PhD
Upstate Medical University, Syracuse, NY
No disclosures

Ara Fernandez, MD, FAAP
Harlem Hospital Center, New York, NY
No disclosures

Annette Gaudino, Community Advisor
Treatment Action Group (TAG), New York, NY
No disclosures

Courtney Olson-Chen, MD
University of Rochester Medical School, Rochester, NY
No disclosures

Maria Teresa (Tess) Timoney, MS, RN, CNM
Bronx Lebanon Hospital Center, Bronx, NY
No disclosures

Geoffrey A. Weinberg, MD
University of Rochester School of Medicine and Dentistry, Rochester, NY
No disclosures

Substance Use Guideline Committee

Updated February 2020

Leadership

Chair: Chinazo O. Cunningham, MD, MS
Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY
No disclosures

Vice-Chair: Kelly S. Ramsey, MD, MPH, MA, FACP
New York State Office of Addiction Services and Supports, Albany, NY
No disclosures

Medical Director: Charles J. Gonzalez, MD
New York State Department of Health AIDS Institute, New York, NY
No disclosures

Deputy Medical Director: Lyn C. Stevens, MS, NP, ACRN
New York State Department of Health AIDS Institute, Albany, NY
No disclosures

JHU Principal Investigator: Christopher J. Hoffmann, MD, MPH
Johns Hopkins University School of Medicine, Division of Infectious Diseases, Baltimore, MD
No disclosures

AIDS Institute Clinical Representative, Harm Reduction in Healthcare: Sharon L. Stancliff, MD
New York State Department of Health AIDS Institute, New York, NY
No disclosures

AIDS Institute Clinical Representative, Drug User Health: Narelle Ellendon, RN
New York State Department of Health AIDS Institute, New York, NY
No disclosures

Contributing Members

Marcus Bachhuber, MD, MS
Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY
No disclosures

Michael L. Christie, MD
University of Rochester Medical Center, Rochester, NY
No disclosures

Annette Gaudino, Community Advisor
Treatment Action Group (TAG), New York, NY
No disclosures

Angela G. Giovanniello, PharmD, AAHIVP
Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY
No disclosures

Raymond Harvey, MD
Institute for Family Health, Kingston, NY
No disclosures

Giliane Joseph, MD
Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY
No disclosures

Hillary Kunins, MD, MPH, MS, NYC DOHMH, Queens, NY
New York City Department of Health and Mental Hygiene
No disclosures

Shadi Nahvi, MD, MS
Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY
No disclosures

David C. Perlman, MD
Icahn School of Medicine at Mount Sinai, New York, NY
No disclosures

Susan D. Whitley, MD
New York City Health + Hospitals/Kings County, Brooklyn, NY
No disclosures

Timothy J. Wiegand, MD
University of Rochester Medical Center, Rochester, NY
Consultant: McKesson Corporation

Institutional, Agency, and Program Liaison Advisory Group

Updated February 2020

Sheldon T. Brown, MD
Infectious Diseases
Hudson Valley VA Healthcare System, Montrose, NY

Douglas Fish, MD
Office of Health Insurance Programs
New York State Department of Health, Albany, NY
No disclosures

Emma Kaplan-Lewis, MD
HIV Services, Office of Population Health
NYC Health and Hospitals, New York, NY

Ralph Liporace, MD
Coxsackie Correctional Facility
NYS Department of Corrections and Community Service, Albany NY

Marc Manseau, MD
Office of Alcoholism and Substance Abuse Services
New York State Department of Health, Albany, NY
No disclosures

Monica Parker, PhD
Bloodborne Viruses Laboratory, Wadsworth Center
New York State Department of Health, Albany, NY
No disclosures

Thomas Smith, MD
Office of Mental Health
New York State Psychiatric Institute, New York, NY

Benjamin Tsoi MD, MPH
Bureau of HIV/AIDS Prevention and Control
New York City Department of Health and Mental Hygiene, New York, NY
No disclosures

William M. Valenti, MD, FIDSA, Trillium Health, Rochester, NY
Medical Society of the State of New York
Financial disclosure: Scientific Advisor, Gilead Sciences