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Table 4: Calculating the Child-Turcotte-Pugh (CTP) Score for Severity of Cirrhosis [a]
Notes:

  1. Adapted from U.S. Department of Veterans Affairs Viral Hepatitis and Liver Disease: Child-Turcotte-Pugh Calculator.
  2. CTP score is obtained by adding the score for each parameter. CTP class:
    A = 5 to 6 points (compensated, least severe liver disease)
    B = 7 to 9 points (decompensated, moderately severe liver disease)
    C = 10 to 15 points (decompensated, most severe liver disease)
1 point [b] 2 points [b] 3 points [b]
Encephalopathy None Stage 1 to 2
(or precipitant-induced)		 Stage 3 to 4
(or chronic)
Ascites None Mild/moderate
(diuretic-responsive)		 Severe
(diuretic-refractory)
Bilirubin (mg/dL) <2.0 2.0 to 3.0 >3.0
Albumin (g/dL) >3.5 2.8 to 3.5 <2.8
Prothrombin time (sec prolonged) or international normalized ratio (INR) <4.0 4.0 to 6.0 >6.0
<1.7 1.7 to 2.3 >2.3
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.

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1 2 3
4 5 6
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.

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See Figure 1 for the graphic. See Box 1 for details. See Bad Box 1 Anchor for details.

Where appropriate, links are provided to other NYSDOH AI guidance and guidelines for more information.

For additional information on aging and HIV, see the NYSDOH AI Guidance: Addressing the Needs of Older Patients in HIV Care.

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Recommend Tests

TL RECOMMEND

HPV Prevention
  • Given the increased lifetime risk of persistent human papillomavirus (HPV) infection and increased prevalence of HPV-related cancers, clinicians should recommend the 9-valent HPV vaccine 3-dose series at 0, 2, and 6 months to all individuals with HIV who are 9 to 45 years old regardless of CD4 cell count, prior cervical or anal screening results, HPV test results, HPV-related cytologic changes, or other history of HPV-related lesions. (A3)

Cervical Cancer Prevention
  • In providing comprehensive primary care for adults with HIV, clinicians should ensure that patients at risk of cervical cancer receive age- and risk-appropriate screening (A3) and provide education about harm reduction measures that may reduce the risk, including:
    • HPV vaccination (A2)
    • ART to suppress HIV viral load (A2)
    • Tobacco use cessation (A2)
    • Sexual exposure prevention strategies, including using barrier protection (A3) and reducing the number of sex partners and associated sexual networks when possible (A3)
  • Clinicians should establish a schedule for routine cervical screening based on a patient’s medical history, anatomical inventory, age, and risk profile. (A2)

Post-Cervical Excision HPV Testing
  • After a patient has undergone cervical excision, clinicians should perform cervical cytology with HPV testing as follows: at 6 months post-excision, annually until 3 sequential negative test results have been obtained, and every 3 years thereafter for at least 25 years. (A3)
Screening for Cervical Dysplasia During Pregnancy
  • Clinicians should perform cervical cytology screening for pregnant patients with HIV as appropriate for each patient’s age. (A2†)
  • Clinicians should refer pregnant patients for follow-up with experienced colposcopy providers when the following cervical cytology results are obtained: repeated ASC-US, ASC-US with HPV, negative cytology with persistently positive HPV, ASC-H, or LSIL or greater. (A3)
  • When cervical dysplasia is diagnosed, clinicians should ensure that patients understand the potential risks and benefits and engage pregnant patients in shared decision-making regarding treatment. (A3)
  • Clinicians should follow up on abnormal cytology or colposcopy results, ideally within 6 weeks postpartum. (A2)
Follow-Up of Abnormal Cervical Cytology Results
  • If at 1 year the HPV test result is positive, the clinician should refer the patient for colposcopy. (A2)
  • When a patient of any age with HIV has a cervical cytology result of LSIL, HSIL, ASC-H, AGC, or AIS, the clinician should refer for colposcopy regardless of the HPV test result. (A2)
Management of Cervical Cancer
  • Clinicians should immediately refer patients with HIV and a diagnosis of cervical cancer to a gynecologic oncologist or surgeon trained in the management of cervical cancer. (A*)
  • Clinicians should closely monitor patients with a history of cervical cancer with possible consultation with a gynecologic oncologist after definitive treatment for cancer, which may include surgery, radiation, and chemotherapy. (A3)

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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.

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Shared Decision-Making

References

Abdul-Quader A. S., Feelemyer J., Modi S., et al. Effectiveness of structural-level needle/syringe programs to reduce HCV and HIV infection among people who inject drugs: a systematic review. AIDS Behav 2013;17(9):2878-92. [PMID: 23975473]

Alexander J. A., Hearld L. R., Mittler J. N., et al. Patient-physician role relationships and patient activation among individuals with chronic illness. Health Serv Res 2012;47(3 Pt 1):1201-23. [PMID: 22098418]

Anderson P. L., Garcia-Lerma J. G., Heneine W. Nondaily preexposure prophylaxis for HIV prevention. Curr Opin HIV AIDS 2016;11(1):94-101. [PMID: 26633641]

Anderson P. L., Glidden D. V., Liu A., et al. Emtricitabine-tenofovir concentrations and pre-exposure prophylaxis efficacy in men who have sex with men. Sci Transl Med 2012;4(151):151ra125. [PMID: 22972843]

Antoni G., Tremblay C., Delaugerre C., et al. On-demand pre-exposure prophylaxis with tenofovir disoproxil fumarate plus emtricitabine among men who have sex with men with less frequent sexual intercourse: a post-hoc analysis of the ANRS IPERGAY trial. Lancet HIV 2020;7(2):e113-e120. [PMID: 31784343]

Apoola A., Ahmad S., Radcliffe K. Primary HIV infection. Int J STD AIDS 2002;13(2):71-8. [PMID: 11839160]

AVAC. Webinar: Time to protection for PrEP. 2017 Feb 9. https://www.avac.org/event/webinar-time-protection-prep [accessed 2022 Mar 17]

Baeten J. M., Donnell D., Ndase P., et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med 2012;367(5):399-410. [PMID: 22784037]

. The bidirectional effects of hormone therapy and PrEP in transgender individuals. CROI; 2022 Feb 12-16. https://www.croiconference.org/abstract/the-bidirectional-effects-of-hormone-therapy-and-prep-in-transgender-individuals/

. Predictors of PrEP adherence and retention in US cisgender women at risk for HIV. CROI; 2021 Mar 6-10. https://www.croiconference.org/abstract/predictors-of-prep-adherence-and-retention-in-us-cisgender-women-at-risk-for-hiv/

Brady, M.. BHIVA/BASHH guidelines on the use of HIV pre-exposure prophylaxis (PrEP) 2018. 2018.. https://www.bhiva.org/PrEP-guidelines [accessed 2022 Mar 17]

. DISCOVER: No effect of hormones on F/TAF or F/TDF PK, efficacy & safety in transwomen. CROI; 2020 Mar 8-11. https://www.croiconference.org/abstract/discover-no-effect-of-hormones-on-f-taf-or-f-tdf-pk-efficacy-safety-in-transwomen/

FDA. Truvada package insert. 2016 Mar. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021752s047lbl.pdf [accessed 2022 Mar 17]

NYSDOH 2018. [**NOTE: This Reference is broken and needs repair] . Unpublished data. 2018.;():-. [PMID: ]

Ryan, et al. 2018 [**NOTE: This Reference is broken and needs repair] . Let’s talk about sex: A survey of patients’ preferences when addressing sexual health concerns in a family medicine residency program office. PRiMER 2018;2(23):-. [PMID: ]

Zule W. A., Costenbader E. C., Meyer W. J., et al. Methamphetamine use and risky sexual behaviors during heterosexual encounters. Sex Transm Dis 2007;34(9):689-94. [PMID: 17471112]

Updates, Authorship, and Related Guidelines

Updates, Authorship, and Related Guidelines
Date of original publication January 2022
Date of current publication January 15, 2023
Highlights of changes, additions, and updates in the January 15, 2023 edition

Date Day Digit test
Intended users NYS clinicians
Lead author(s)

Smith James A., MD, CSPO1; Johnson Randall J., PhD, MD2

1Binghamton University
2Brown University
Writing group

Mitchell Marcia, MD; Newton-John Olivia, PhD, MD, JD1

1Johns Hopkins
Author and writing group conflict of interest disclosures There are no author or writing group conflict of interest disclosures
Committee

Medical Care Criteria Committee
Developer and funder

Development process

See Guideline Development and Recommendation Ratings Scheme, below.

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.