Diagnosis and management of vulvar skin disorders.
General
Guideline Title
Diagnosis and management of vulvar skin disorders.
Bibliographic Source(s)
- American College of Obstetricians and Gynecologists (ACOG). Diagnosis and management of vulvar skin disorders. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2008 May. 11 p. (ACOG practice bulletin; no. 93). [90 references]
Guideline Status
This is the current release of the guideline.
The American College of Obstetricians and Gynecologists (ACOG) reaffirmed the currency of this guideline in 2013.
Recommendations
Major Recommendations
The grades of evidence (I-III) and levels of recommendation (A-C) are defined at the end of the “Major Recommendations” field.
The following recommendation is based on limited or inconsistent scientific evidence (Level B) :
- The recommended treatment for lichen sclerosus is an ultrapotent topical corticosteroid, such as clobetasol propionate.
The following recommendations are based primarily on consensus and expert opinion (Level C) :
- Biopsy of hyperpigmented or exophytic lesions, lesions with changes in vascular patterns, or unresolving lesions is particularly important and should be performed to rule out carcinoma.
- For patients with biopsy-confirmed Paget disease, further evaluation of the breast, genitourinary tract, and gastrointestinal tract should be undertaken.
**Definitions ** :
Grades of Evidence
I Evidence obtained from at least one properly designed randomized controlled trial.
II-1 Evidence obtained from well-designed controlled trials without randomization.
II-2 Evidence obtained from well-designed cohort or case–control analytic studies, preferably from more than one center or research group.
II-3 Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments also could be regarded as this type of evidence.
III Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.
Levels of Recommendation
Level A — Recommendations are based on good and consistent scientific evidence.
Level B — Recommendations are based on limited or inconsistent scientific evidence.
Level C — Recommendations are based primarily on consensus and expert opinion.
Clinical Algorithm(s)
None provided
Scope
Disease/Condition(s)
Vulvar skin disorders, including:
- Vulvar dermatoses: contact dermatitis, lichen simplex chronicus, lichen sclerosus, lichen planus
- Vulvar atrophy
- Genital human papillomavirus (HPV) infection
- Paget disease
- Crohn’s disease
Guideline Category
- Diagnosis
- Evaluation
- Management
- Treatment
Clinical Specialty
- Family Practice
- Infectious Diseases
- Obstetrics and Gynecology
- Pediatrics
Intended Users
- Physicians
Guideline Objective(s)
- To aid practitioners in making decisions about appropriate obstetric and gynecologic care
- To review diagnostic approaches and provide a structured framework for the management of vulvar disorders
Target Population
Women and female children and adolescents with symptoms of vulvar disorders
Interventions and Practices Considered
Evaluation and Diagnosis
- Evaluation of signs and symptoms (e.g., vulvar pain, pruritus)
- Medical history
- Search for common vulvar irritants and allergens
- Vulvar biopsy
- Additional diagnostic tests (e.g., culture, microscopy, vaginal pH)
Treatment and Management
- Topical therapies * Estrogen and testosterone creams * Topical steroid cream (clobetasol propionate) * Nonhormonal vaginal moisturizer
- Systemic immunosuppressive therapies
- Surgery
- Further evaluation of biopsy-confirmed Paget disease
Major Outcomes Considered
- Symptom relief
- Sexual function
- Well-being
Methodology
Methods Used to Collect/Select the Evidence
- Hand-searches of Published Literature (Primary Sources)
- Hand-searches of Published Literature (Secondary Sources)
- Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence
2008 Guideline
The MEDLINE database, the Cochrane Library, and the American College of Obstetricians and Gynecologists’ own internal resources and documents were used to conduct a literature search to locate relevant articles published between January 1985 and August 2007. The search was restricted to articles published in the English language. Priority was given to articles reporting results of original research, although review articles and commentaries also were consulted. Abstracts of research presented at symposia and scientific conferences were not considered adequate for inclusion in this document. Guidelines published by organizations or institutions such as the National Institutes of Health and the American College of Obstetricians and Gynecologists were reviewed, and additional studies were located by reviewing bibliographies of identified articles.
2013 Reaffirmation
The NCBI database was searched from 2008 to 2013. Committee members conducted a literature search with the assistance from the ACOG Resource Center staff who routinely perform the Practice Bulletin literature searches.
Number of Source Documents
Not stated
Methods Used to Assess the Quality and Strength of the Evidence
- Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence
Studies were reviewed and evaluated for quality according to the method outlined by the U.S. Preventive Services Task Force:
I Evidence obtained from at least one properly designed randomized controlled trial.
II-1 Evidence obtained from well-designed controlled trials without randomization.
II-2 Evidence obtained from well-designed cohort or case–control analytic studies, preferably from more than one center or research group.
II-3 Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments also could be regarded as this type of evidence.
III Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.
Methods Used to Analyze the Evidence
- Review of Published Meta-Analyses
- Systematic Review
Description of the Methods Used to Analyze the Evidence
Not stated
Methods Used to Formulate the Recommendations
- Expert Consensus
Description of Methods Used to Formulate the Recommendations
2008 Guideline
Analysis of available evidence was given priority in formulating recommendations. When reliable research was not available, expert opinions from obstetrician–gynecologists were used. See also the “Rating Scheme for the Strength of Recommendations” field regarding Grade C recommendations.
2013 Reaffirmation
The Committee on Practice Bulletins - Gynecology met in March 2013 and reaffirmed this document. A committee member reviewed the document and new literature on the topic. The document was then reviewed by the committee and the committee agreed that it is current and accurate.
Rating Scheme for the Strength of the Recommendations
Based on the highest level of evidence found in the data, recommendations are provided and graded according to the following categories:
Level A — Recommendations are based on good and consistent scientific evidence.
Level B — Recommendations are based on limited or inconsistent scientific evidence.
Level C — Recommendations are based primarily on consensus and expert opinion.
Cost Analysis
A formal cost analysis was not performed and published cost analyses were not reviewed.
Method of Guideline Validation
- Internal Peer Review
Description of Method of Guideline Validation
Practice Bulletins are validated by two internal clinical review panels composed of practicing obstetrician-gynecologists generalists and sub-specialists. The final guidelines are also reviewed and approved by the American College of Obstetricians and Gynecologists (ACOG) Executive Board.
Evidence Supporting the Recommendations
Type of Evidence Supporting the Recommendations
The type of supporting evidence is identified and graded for each recommendation (see “Major Recommendations”).
Benefits/Harms of Implementing the Guideline Recommendations
Potential Benefits
Accurate diagnosis and appropriate management of vulvar skin disorders
Potential Harms
- Side effects of:
- Topical estrogen therapy in girls
- Topical steroid therapy
- Systemic immunosuppressants
- When compared in randomized controlled trials with either estrogen tablets or with the estrogen ring, conjugated equine estrogen cream was found to be significantly associated with adverse effects, including bleeding, breast pain, and perineal pain.
- All forms of topical estrogen therapy increase the possibility of endometrial hyperplasia and overstimulation.
Qualifying Statements
Qualifying Statements
These guidelines should not be construed as dictating an exclusive course of treatment or procedure. Variations in practice may be warranted based on the needs of the individual patient, resources, and limitations unique to the institution or type of practice.
Implementation of the Guideline
Description of Implementation Strategy
An implementation strategy was not provided.
Implementation Tools
- Audit Criteria/Indicators
Institute of Medicine (IOM) National Healthcare Quality Report Categories
IOM Care Need
- Getting Better
- Living with Illness
IOM Domain
- Effectiveness
- Patient-centeredness
Identifying Information and Availability
Bibliographic Source(s)
- American College of Obstetricians and Gynecologists (ACOG). Diagnosis and management of vulvar skin disorders. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2008 May. 11 p. (ACOG practice bulletin; no. 93). [90 references]
Adaptation
Not applicable: The guideline was not adapted from another source.
Date Released
2008 May (reaffirmed 2013)
Guideline Developer(s)
- American College of Obstetricians and Gynecologists - Medical Specialty Society
Source(s) of Funding
American College of Obstetricians and Gynecologists (ACOG)
Guideline Committee
American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins - Gynecology
Composition of Group That Authored the Guideline
Not stated
Financial Disclosures/Conflicts of Interest
Not stated
Guideline Status
This is the current release of the guideline.
The American College of Obstetricians and Gynecologists (ACOG) reaffirmed the currency of this guideline in 2013.
Guideline Availability
No electronic copies available
Print copies: Available for purchase from the American College of Obstetricians and Gynecologists (ACOG) Distribution Center, PO Box 933104, Atlanta, GA 31193-3104; telephone, 800-762-2264, ext. 192; e-mail: sales@acog.org. The ACOG Bookstore is available online at the ACOG Web site.
Availability of Companion Documents
Proposed performance measures are included in the original guideline document.
Patient Resources
None available
NGC Status
This NGC summary was completed by ECRI Institute on July 29, 2008. The information was verified by the guideline developer on August 20, 2008. This summary was updated by ECRI Institute on August 18, 2009, following the revised FDA advisory on CellCept (mycophenolate mofetil). The currency of the guideline was reaffirmed by the developer in 2013 and this summary was updated by ECRI Institute on March 7, 2014.
Copyright Statement
This NGC summary is based on the original guideline, which is subject to the guideline developer’s copyright restrictions.
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