Guidance: Adolescent Consent to HIV and STI Treatment and Prevention

May 08, 2024

Purpose of This Guidance

Date of current publication: May 8, 2024
Lead author: New York State Department of Health AIDS Institute (NYSDOH AI)
Original lead author: Uri Belkind, MD, MS
Writing group: Rona M. Vail, MD, AAHIVS; Sanjiv S. Shah, MD, MPH, AAHIVM, AAHIVS; Steven M. Fine, MD, PhD; Joseph P. McGowan, MD, FACP, FIDSA, AAHIVS; Samuel T. Merrick, MD, FIDSA; Asa E. Radix, MD, MPH, PhD, FACP, AAHIVS; Jessica Rodrigues, MPH, MS; Christopher J. Hoffmann, MD, MPH, MSc, FACP; Brianna L. Norton, DO, MPH; Charles J. Gonzalez, MD
Committee: Medical Care Criteria Committee
Date of original publication: January 6, 2021

This guidance was developed by the New York State Department of Health AIDS Institute (NYSDOH AI) Clinical Guidelines Program. Its purpose is to inform New York State clinicians who provide primary care to adolescents about existing regulations that allow minors (<18 years old) to consent for and receive confidential HIV and sexually transmitted infection (STI) screening and treatment and biomedical HIV prevention in the form of pre- or post-exposure prophylaxis (PrEP or PEP).

Many adolescents in New York State self-report being sexually active, with approximately 40% of high school students reporting that they engaged in sexual intercourse by 12th grade CDC 2021. Sexually active youth are disproportionately affected by STIs compared with adults: 47% of all reported STIs are among young people, yet this age group represents only about 13% of New Yorkers. These available data represent only a portion of the true burden because many cases go undiagnosed, unreported, and untreated NYSDOH 2022. Public health concerns regarding adolescent burden of HIV also exist, given that approximately 20% of young people are not linked to care within 30 days of HIV diagnosis and those within care have lower rates of HIV viral suppression (70%) than the overall state rate (79%) NYSDOH 2023.

Ensuring appropriate care delivery: The primary goal for clinicians treating minors living with HIV is providing appropriate care that prevents HIV disease progression and transmission. In providing healthcare for minors at risk of acquiring HIV, clinicians play a pivotal role in helping to end the HIV epidemic by:

  • Identifying minors who may benefit from PrEP and PEP
  • Providing education and counseling about PrEP and PEP use, so that they may be accessed when needed
  • Ensuring confidentiality and preventing accidental disclosure of HIV status
  • Ensuring retention in care with provision of combination antiretroviral therapy to promote achievement of “Undetectable = Untransmittable” (U=U)

Reducing barriers to care: To help reduce barriers and delays in accessing care, New York State law allows minors to seek HIV prevention and treatment without disclosing to or obtaining consent from a parent or guardian. This guidance does not intend to minimize the role of supportive parents, guardians, or other adults who may provide additional support to help adolescent patients adhere to their treatment plans.

Retention in care: Adolescents with HIV should be encouraged to remain in care and keep scheduled appointments. Adolescents may consent to and are eligible for all of the following essential medical services:

New York State Law and Federal Law

Minors consent in New York State: According to New York State Public Health Law Article 23, Title 1, Section 2305, individuals <18 years old may give effective informed consent for services related to screening, treatment, and prevention of STIs, including HIV (see also New York Codes, Rules and Regulations [NYCRR], Title 10, Section 23.4). See the NYSDOH document Frequently Asked Questions: Guidance for Local Health Departments (LHD) and Health Care Providers on STI Billing and Minor’s Consent to Prevention Services and HIV-related Services.

Minor consent laws vary by state, and clinicians should be familiar with state laws. Clinicians who practice outside of New York State should be familiar with local and state laws, as well as with institutional policies to obtain guidance on how to care for minors living with or at risk for HIV who are unable or unwilling to disclose this to their parents or guardians, with the understanding that current evidence strongly favors early treatment for improved individual and public health outcomes.

Immunization reporting in New York State: The New York State Immunization Registry Law requires healthcare providers to report the immunization history for and all immunizations administered to patients <19 years old using the New York State Immunization Information System or, in New York City, to the Citywide Immunization Registry. There are no exemptions to the reporting mandate, so vaccination against human papillomavirus (HPV) is required as well. Minors who independently consent to vaccination against HPV should be advised of these reporting requirements and further advised that any immunization-specific information reported to the New York State or New York City systems may be requested by a parent or guardian NYSDOH 2019.

Federal law: Federal law 45 CFR §164.524 requires that healthcare providers give patients access without charge to all of the health information in their electronic medical records. There are many potential advantages to sharing health information with patients and families. However, there are important implications for minors who access confidential services, including but not limited to HIV screening, treatment, and prevention. Individual organizations can choose how to share information with parents of minors and with minor patients themselves, and it is the responsibility of each organization to do so in a manner that maintains the right of adolescent minors to access confidential care. Healthcare providers should become familiar with their institutional policies regarding health information sharing for minors, should advocate for policies that incorporate adolescent confidentiality protections, and should be able to provide guidance to minors on how to access and protect their health information.


Disclosure, Consent, and Confidentiality

Disclosure: It is important that clinicians engage adolescent patients in dialogue about the potential advantages or disadvantages of disclosing their HIV status to parents, legal guardians, or any other adult who may provide support and that they facilitate such conversations at a patient’s request. Determining whether a minor’s health or well-being may be at risk if they disclose their HIV status to their parent or legal guardian is crucial to establishing a framework for patient care. It is important to know, for example, if a young man who has sex with men may risk being forced out of his home if he discloses his HIV status or his sexual identity to his parents or legal guardians or if a young woman who has acquired HIV through sexual transmission may fear physical abuse if her family learns of her sexual activity.

  • Adolescents may be at risk of abuse if they disclose that they have HIV or are at risk of acquiring HIV. Appropriate referrals and assistance should be offered to patients reporting such risk.
  • Discussions about disclosure and possible risks to the adolescent can be documented in the medical record.
  • Supportive adults may be an important resource to help adolescent patients remain engaged in care. Clinicians can help patients identify supportive adults and facilitate conversations around disclosure if requested.

Consent and confidentiality: Many healthcare facilities have established policies and procedures for obtaining consent for minors to receive HIV care, including prevention. In the absence of such policies and procedures in their respective facilities, clinicians can consult their facility’s legal or risk management departments. A lack of institutional policies that address consent and confidentiality for minors should not prevent clinicians from offering services that minors are legally allowed to access independently.

Education about and assistance with an insurance plan’s member services regarding the following rights is essential so adolescents are able to:

  • Opt out of explanations of benefits or other communications (e.g., prior authorization notices) that are mailed to their parents or legal guardians regarding HIV care
  • Request that insurance cards be mailed to the address of their choice (e.g., an alternate to family address)
  • Ensure that information is not inadvertently disclosed through electronic portals that parents or legal guardians are able to access (see discussion in guideline section New York State and Federal Law).

Care providers are encouraged to provide hands-on assistance to adolescents when they need it to complete these tasks. Requirements vary across insurance companies and are not always straightforward. The NYSDOH HIV Testing, Reporting and Confidentiality in New York State 2023 Update provides information about minors’ confidentiality rights with insurance companies. See NYSDOH HIV/AIDS Laws & Regulations for information on laws pertaining to HIV testing, reporting, and confidentiality.

  • Coordination with insurance companies is necessary to ensure that confidentiality is managed according to the wishes of an adolescent patient.

Good Practice Reminders and Resources

The following good practice reminders are for care providers who provide health services to adolescents in New York State:

  • Stay up to date on New York State law regarding consent and confidentiality for adolescents.
  • Ensure that adolescents <18 years old receive confidential care for HIV treatment and prevention.
  • Educate adolescents who have or are at risk of HIV about the law and their rights.
  • Inform adolescent patients about New York State reporting requirements (see NYSDOH HIV Reporting & Partner Services > Five Things to Know About HIV/AIDS Reporting in New York State and NYSDOH Communicable Disease Reporting Requirements).
  • Ensure that institutional policies reflect New York State law regarding adolescents <18 years old who seek care for HIV treatment or prevention and who choose not to disclose this to their parents or legal guardians.
  • Encourage adolescents who consent to their own care to identify an adult who can provide support.
  • Make every effort to prevent disclosure of confidential information through release of medical records, pharmacy records, or explanation of benefits by creating clear policies and providing resources to help adolescent minors navigate the complexities of the healthcare system.

Shared Decision-Making

Download Printable PDF of Shared Decision-Making Statement

Date of current publication: August 8, 2023
Lead authors:
Jessica Rodrigues, MS; Jessica M. Atrio, MD, MSc; and Johanna L. Gribble, MA
Writing group: Steven M. Fine, MD, PhD; Rona M. Vail, MD; Samuel T. Merrick, MD; Asa E. Radix, MD, MPH, PhD; Christopher J. Hoffmann, MD, MPH; Charles J. Gonzalez, MD
Committee: Medical Care Criteria Committee
Date of original publication: August 8, 2023


Throughout its guidelines, the New York State Department of Health (NYSDOH) AIDS Institute (AI) Clinical Guidelines Program recommends “shared decision-making,” an individualized process central to patient-centered care. With shared decision-making, clinicians and patients engage in meaningful dialogue to arrive at an informed, collaborative decision about a patient’s health, care, and treatment planning. The approach to shared decision-making described here applies to recommendations included in all program guidelines. The included elements are drawn from a comprehensive review of multiple sources and similar  attempts to define shared decision-making, including the Institute of Medicine’s original description [Institute of Medicine 2001]. For more information, a variety of informative resources and suggested readings are included at the end of the discussion.


The benefits to patients that have been associated with a shared decision-making approach include:

  • Decreased anxiety [Niburski, et al. 2020; Stalnikowicz and Brezis 2020]
  • Increased trust in clinicians [Acree, et al. 2020; Groot, et al. 2020; Stalnikowicz and Brezis 2020]
  • Improved engagement in preventive care [McNulty, et al. 2022; Scalia, et al. 2022; Bertakis and Azari 2011]
  • Improved treatment adherence, clinical outcomes, and satisfaction with care [Crawford, et al. 2021; Bertakis and Azari 2011; Robinson, et al. 2008]
  • Increased knowledge, confidence, empowerment, and self-efficacy [Chen, et al. 2021; Coronado-Vázquez, et al. 2020; Niburski, et al. 2020]


Collaborative care: Shared decision-making is an approach to healthcare delivery that respects a patient’s autonomy in responding to a clinician’s recommendations and facilitates dynamic, personalized, and collaborative care. Through this process, a clinician engages a patient in an open and respectful dialogue to elicit the patient’s knowledge, experience, healthcare goals, daily routine, lifestyle, support system, cultural and personal identity, and attitudes toward behavior, treatment, and risk. With this information and the clinician’s clinical expertise, the patient and clinician can collaborate to identify, evaluate, and choose from among available healthcare options [Coulter and Collins 2011]. This process emphasizes the importance of a patient’s values, preferences, needs, social context, and lived experience in evaluating the known benefits, risks, and limitations of a clinician’s recommendations for screening, prevention, treatment, and follow-up. As a result, shared decision-making also respects a patient’s autonomy, agency, and capacity in defining and managing their healthcare goals. Building a clinician-patient relationship rooted in shared decision-making can help clinicians engage in productive discussions with patients whose decisions may not align with optimal health outcomes. Fostering open and honest dialogue to understand a patient’s motivations while suspending judgment to reduce harm and explore alternatives is particularly vital when a patient chooses to engage in practices that may exacerbate or complicate health conditions [Halperin, et al. 2007].

Options: Implicit in the shared decision-making process is the recognition that the “right” healthcare decisions are those made by informed patients and clinicians working toward patient-centered and defined healthcare goals. When multiple options are available, shared decision-making encourages thoughtful discussion of the potential benefits and potential harms of all options, which may include doing nothing or waiting. This approach also acknowledges that efficacy may not be the most important factor in a patient’s preferences and choices [Sewell, et al. 2021].

Clinician awareness: The collaborative process of shared decision-making is enhanced by a clinician’s ability to demonstrate empathic interest in the patient, avoid stigmatizing language, employ cultural humility, recognize systemic barriers to equitable outcomes, and practice strategies of self-awareness and mitigation against implicit personal biases [Parish, et al. 2019].

Caveats: It is important for clinicians to recognize and be sensitive to the inherent power and influence they maintain throughout their interactions with patients. A clinician’s identity and community affiliations may influence their ability to navigate the shared decision-making process and develop a therapeutic alliance with the patient and may affect the treatment plan [KFF 2023; Greenwood, et al. 2020]. Furthermore, institutional policy and regional legislation, such as requirements for parental consent for gender-affirming care for transgender people or insurance coverage for sexual health care, may infringe upon a patient’s ability to access preventive- or treatment-related care [Sewell, et al. 2021].

Figure 1: Elements of Shared Decision-Making

Figure 1: Elements of Shared Decision-Making

Download figure: Elements of Shared Decision-Making

Health equity: Adapting a shared decision-making approach that supports diverse populations is necessary to achieve more equitable and inclusive health outcomes [Castaneda-Guarderas, et al. 2016]. For instance, clinicians may need to incorporate cultural- and community-specific considerations into discussions with women, gender-diverse individuals, and young people concerning their sexual behaviors, fertility intentions, and pregnancy or lactation status. Shared decision-making offers an opportunity to build trust among marginalized and disenfranchised communities by validating their symptoms, values, and lived experience. Furthermore, it can allow for improved consistency in patient screening and assessment of prevention options and treatment plans, which can reduce the influence of social constructs and implicit bias [Castaneda-Guarderas, et al. 2016].

Clinician bias has been associated with health disparities and can have profoundly negative effects [FitzGerald and Hurst 2017; Hall, et al. 2015]. It is often challenging for clinicians to recognize and set aside personal biases and to address biases with peers and colleagues. Consciously or unconsciously, negative or stigmatizing assumptions are often made about patient characteristics, such as race, ethnicity, gender, sexual orientation, mental health, and substance use [Avery, et al. 2019; van Boekel, et al. 2013; Livingston, et al. 2012]. With its emphasis on eliciting patient information, a shared decision-making approach encourages clinicians to inquire about patients’ lived experiences rather than making assumptions and to recognize the influence of that experience in healthcare decision-making.

Stigma: Stigma may prevent individuals from seeking or receiving treatment and harm reduction services [Tsai, et al. 2019]. Among people with HIV, stigma and medical mistrust remain significant barriers to healthcare utilization, HIV diagnosis, and medication adherence and can affect disease outcomes [Turan, et al. 2017; Chambers, et al. 2015], and stigma among clinicians against people who use substances has been well-documented [Stone, et al. 2021; Tsai, et al. 2019; van Boekel, et al. 2013]. Sexual and reproductive health, including strategies to prevent HIV transmission, acquisition, and progression, may be subject to stigma, bias, social influence, and violence.

  • As prevention and treatment modalities in HIV care expand (i.e., vaccines, barriers, injectables, implants, on-demand therapies), it is important for clinicians to ask patients about their goals for prevention and treatment rather than assume that efficacy is the primary factor in patient preference [Sewell, et al. 2021].
  • The shared decision-making approach to clinical care enhances patient knowledge and uptake of new technologies and behavioral practices that align with the patient’s unique preferences and identity [Sewell, et al. 2021], ensures that the selection of a care plan is mutually agreed upon, and considers the patient’s ability to effectively use and adhere to the selected course of prevention or treatment.

Resources and Suggested Reading

In addition to the references cited below, the following resources and suggested reading may be useful to clinicians.


Acree ME, McNulty M, Blocker O, et al. Shared decision-making around anal cancer screening among black bisexual and gay men in the USA. Cult Health Sex 2020;22(2):201-16. [PMID: 30931831]

Avery JD, Taylor KE, Kast KA, et al. Attitudes toward individuals with mental illness and substance use disorders among resident physicians. Prim Care Companion CNS Disord 2019;21(1):18m02382. [PMID: 30620451]

Bertakis KD, Azari R. Patient-centered care is associated with decreased health care utilization. J Am Board Fam Med 2011;24(3):229-39. [PMID: 21551394]

Castaneda-Guarderas A, Glassberg J, Grudzen CR, et al. Shared decision making with vulnerable populations in the emergency department. Acad Emerg Med 2016;23(12):1410-16. [PMID: 27860022]

Chambers LA, Rueda S, Baker DN, et al. Stigma, HIV and health: a qualitative synthesis. BMC Public Health 2015;15:848. [PMID: 26334626]

Chen CH, Kang YN, Chiu PY, et al. Effectiveness of shared decision-making intervention in patients with lumbar degenerative diseases: a randomized controlled trial. Patient Educ Couns 2021;104(10):2498-2504. [PMID: 33741234]

Coronado-Vázquez V, Canet-Fajas C, Delgado-Marroquín MT, et al. Interventions to facilitate shared decision-making using decision aids with patients in primary health care: a systematic review. Medicine (Baltimore) 2020;99(32):e21389. [PMID: 32769870]

Coulter A, Collins A. Making shared decision-making a reality: no decision about me, without me. 2011.

Crawford J, Petrie K, Harvey SB. Shared decision-making and the implementation of treatment recommendations for depression. Patient Educ Couns 2021;104(8):2119-21. [PMID: 33563500]

FitzGerald C, Hurst S. Implicit bias in healthcare professionals: a systematic review. BMC Med Ethics 2017;18(1):19. [PMID: 28249596]

Greenwood BN, Hardeman RR, Huang L, et al. Physician-patient racial concordance and disparities in birthing mortality for newborns. Proc Natl Acad Sci U S A 2020;117(35):21194-21200. [PMID: 32817561]

Groot G, Waldron T, Barreno L, et al. Trust and world view in shared decision making with indigenous patients: a realist synthesis. J Eval Clin Pract 2020;26(2):503-14. [PMID: 31750600]

Hall WJ, Chapman MV, Lee KM, et al. Implicit racial/ethnic bias among health care professionals and its influence on health care outcomes: a systematic review. Am J Public Health 2015;105(12):e60-76. [PMID: 26469668]

Halperin B, Melnychuk R, Downie J, et al. When is it permissible to dismiss a family who refuses vaccines? Legal, ethical and public health perspectives. Paediatr Child Health 2007;12(10):843-45. [PMID: 19043497]

Institute of Medicine. Crossing the quality chasm: a new health system for the 21st century. 2001.

KFF. Key data on health and health care by race and ethnicity. 2023 Mar 15. [accessed 2023 May 19]

Livingston JD, Milne T, Fang ML, et al. The effectiveness of interventions for reducing stigma related to substance use disorders: a systematic review. Addiction 2012;107(1):39-50. [PMID: 21815959]

McNulty MC, Acree ME, Kerman J, et al. Shared decision making for HIV pre-exposure prophylaxis (PrEP) with black transgender women. Cult Health Sex 2022;24(8):1033-46. [PMID: 33983866]

Niburski K, Guadagno E, Abbasgholizadeh-Rahimi S, et al. Shared decision making in surgery: a meta-analysis of existing literature. Patient 2020;13(6):667-81. [PMID: 32880820]

Parish SJ, Hahn SR, Goldstein SW, et al. The International Society for the Study of Women’s Sexual Health process of care for the identification of sexual concerns and problems in women. Mayo Clin Proc 2019;94(5):842-56. [PMID: 30954288]

Robinson JH, Callister LC, Berry JA, et al. Patient-centered care and adherence: definitions and applications to improve outcomes. J Am Acad Nurse Pract 2008;20(12):600-607. [PMID: 19120591]

Scalia P, Durand MA, Elwyn G. Shared decision-making interventions: an overview and a meta-analysis of their impact on vaccine uptake. J Intern Med 2022;291(4):408-25. [PMID: 34700363]

Sewell WC, Solleveld P, Seidman D, et al. Patient-led decision-making for HIV preexposure prophylaxis. Curr HIV/AIDS Rep 2021;18(1):48-56. [PMID: 33417201]

Stalnikowicz R, Brezis M. Meaningful shared decision-making: complex process demanding cognitive and emotional skills. J Eval Clin Pract 2020;26(2):431-38. [PMID: 31989727]

Stone EM, Kennedy-Hendricks A, Barry CL, et al. The role of stigma in U.S. primary care physicians’ treatment of opioid use disorder. Drug Alcohol Depend 2021;221:108627. [PMID: 33621805]

Tsai AC, Kiang MV, Barnett ML, et al. Stigma as a fundamental hindrance to the United States opioid overdose crisis response. PLoS Med 2019;16(11):e1002969. [PMID: 31770387]

Turan B, Budhwani H, Fazeli PL, et al. How does stigma affect people living with HIV? The mediating roles of internalized and anticipated HIV stigma in the effects of perceived community stigma on health and psychosocial outcomes. AIDS Behav 2017;21(1):283-91. [PMID: 27272742]

van Boekel LC, Brouwers EP, van Weeghel J, et al. Stigma among health professionals towards patients with substance use disorders and its consequences for healthcare delivery: systematic review. Drug Alcohol Depend 2013;131(1-2):23-35. [PMID: 23490450]


CDC. Youth online: youth risk behavior surveillance system. 2021. [accessed 2024 May 1]

NYSDOH. Frequently asked questions: guidance for local health departments (LHD) and health care providers on STI billing and minor's consent to prevention services and HIV-related services. 2019 Nov. [accessed 2024 May 1]

NYSDOH. Sexually transmitted infections surveillance report 2022. 2022. [accessed 2024 May 1]

NYSDOH. HIV care in New York State, 2022: linkage to care and viral suppression among persons with diagnosed HIV residing in New York State. 2023 Oct. [accessed 2024 May 1]

Updates, Authorship, and Related Guidelines

Updates, Authorship, and Related Guidelines
Date of original publication January 06, 2021
Date of current publication May 08, 2024
Highlights of changes, additions, and updates in the May 08, 2024 edition

Resources, citations, and references updated throughout this guidance.

Intended users New York State clinicians who provide primary care to adolescents (<18 years old)
Lead author

New York State Department of Health AIDS Institute (NYSDOH AI),

Writing group

Rona M. Vail, MD, AAHIVS; Sanjiv S. Shah, MD, MPH, AAHIVM, AAHIVS; Steven M. Fine, MD, PhD; Joseph P. McGowan, MD, FACP, FIDSA, AAHIVS; Samuel T. Merrick, MD, FIDSA; Asa E. Radix, MD, MPH, PhD, FACP, AAHIVS; Jessica Rodrigues, MPH, MS; Christopher J. Hoffmann, MD, MPH, MSc, FACP; Brianna L. Norton, DO, MPH; Charles J. Gonzalez, MD

Author and writing group conflict of interest disclosures There are no author or writing group conflict of interest disclosures.

Medical Care Criteria Committee

Developer and funder

New York State Department of Health AIDS Institute (NYSDOH AI)

Development process

See Guideline Development and Recommendation Ratings Scheme, below.

Related NYSDOH AI guidelines

Related NYSDOH AI Guidance

Guideline Development and Recommendation Ratings

Guideline Development: New York State Department of Health AIDS Institute Clinical Guidelines Program
Program manager Clinical Guidelines Program, Johns Hopkins University School of Medicine, Division of Infectious Diseases. See Program Leadership and Staff.
Mission To produce and disseminate evidence-based, state-of-the-art clinical practice guidelines that establish uniform standards of care for practitioners who provide prevention or treatment of HIV, viral hepatitis, other sexually transmitted infections, and substance use disorders for adults throughout New York State in the wide array of settings in which those services are delivered.
Expert committees The NYSDOH AI Medical Director invites and appoints committees of clinical and public health experts from throughout New York State to ensure that the guidelines are practical, immediately applicable, and meet the needs of care providers and stakeholders in all major regions of New York State, all relevant clinical practice settings, key New York State agencies, and community service organizations.
Committee structure
  • Leadership: AI-appointed chair, vice chair(s), chair emeritus, clinical specialist(s), JHU Guidelines Program Director, AI Medical Director, AI Clinical Consultant, AVAC community advisor
  • Contributing members
  • Guideline writing groups: Lead author, coauthors if applicable, and all committee leaders
Disclosure and management of conflicts of interest
  • Annual disclosure of financial relationships with commercial entities for the 12 months prior and upcoming is required of all individuals who work with the guidelines program, and includes disclosure for partners or spouses and primary professional affiliation.
  • The NYSDOH AI assesses all reported financial relationships to determine the potential for undue influence on guideline recommendations and, when indicated, denies participation in the program or formulates a plan to manage potential conflicts. Disclosures are listed for each committee member.
Evidence collection and review
  • Literature search and review strategy is defined by the guideline lead author based on the defined scope of a new guideline or update.
  • A comprehensive literature search and review is conducted for a new guideline or an extensive update using PubMed, other pertinent databases of peer-reviewed literature, and relevant conference abstracts to establish the evidence base for guideline recommendations.
  • A targeted search and review to identify recently published evidence is conducted for guidelines published within the previous 3 years.
  • Title, abstract, and article reviews are performed by the lead author. The JHU editorial team collates evidence and creates and maintains an evidence table for each guideline.
Recommendation development
  • The lead author drafts recommendations to address the defined scope of the guideline based on available published data.
  • Writing group members review the draft recommendations and evidence and deliberate to revise, refine, and reach consensus on all recommendations.
  • When published data are not available, support for a recommendation may be based on the committee’s expert opinion.
  • The writing group assigns a 2-part rating to each recommendation to indicate the strength of the recommendation and quality of the supporting evidence. The group reviews the evidence, deliberates, and may revise recommendations when required to reach consensus.
Review and approval process
  • Following writing group approval, draft guidelines are reviewed by all contributors, program liaisons, and a volunteer reviewer from the AI Community Advisory Committee.
  • Recommendations must be approved by two-thirds of the full committee. If necessary to achieve consensus, the full committee is invited to deliberate, review the evidence, and revise recommendations.
  • Final approval by the committee chair and the NYSDOH AI Medical Director is required for publication.
External reviews
  • External review of each guideline is invited at the developer’s discretion.
  • External reviewers recognized for their experience and expertise review guidelines for accuracy, balance, clarity, and practicality and provide feedback.
Update process
  • JHU editorial staff ensure that each guideline is reviewed and determined to be current upon the 3-year anniversary of publication; guidelines that provide clinical recommendations in rapidly changing areas of practice may be reviewed annually. Published literature is surveilled to identify new evidence that may prompt changes to existing recommendations or development of new recommendations.
  • If changes in the standard of care, newly published studies, new drug approval, new drug-related warning, or a public health emergency indicate the need for immediate change to published guidelines, committee leadership will make recommendations and immediate updates and will invite full committee review as indicated.
Recommendation Ratings Scheme
Strength Quality of Evidence
Rating Definition Rating Definition
A Strong 1 Based on published results of at least 1 randomized clinical trial with clinical outcomes or validated laboratory endpoints.
B Moderate * Based on either a self-evident conclusion; conclusive, published, in vitro data; or well-established practice that cannot be tested because ethics would preclude a clinical trial.
C Optional 2 Based on published results of at least 1 well-designed, nonrandomized clinical trial or observational cohort study with long-term clinical outcomes.
2† Extrapolated from published results of well-designed studies (including nonrandomized 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 Based on committee expert opinion, with rationale provided in the guideline text.

Last updated on May 13, 2024