EVIDENCE-TO-DECISION TABLE: GENITAL ULCER DISEASE

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Guidelines for the management of symptomatic sexually transmitted infections [Internet]. Geneva: World Health Organization; 2021 Jun.

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Guidelines for the management of symptomatic sexually transmitted infections [Internet].

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ANNEX 6EVIDENCE-TO-DECISION TABLE: GENITAL ULCER DISEASE

Should current WHO syndromic management be recommended versus laboratory diagnosis, no treatment or treat all to identify sexually transmitted infections among people with anogenital ulcers?

Population

Individuals presenting with anogenital ulcers

Intervention and comparator

Intervention: syndromic management approach versus comparison: laboratory diagnosis (or no treatment or treat all)

Purpose of the approach

To identify individuals for treatment of STIs

Linked treatments

Treatments for infections caused by genital herpes simplex virus, Treponema pallidum (syphilis), lymphogranuloma venereum and Hemophilus ducreyi (chancroid)

Anticipated outcomes

Number of people identified correctly as having or not having STI; number of people identified incorrectly as having or not having STI; consequences of appropriate or inappropriate treatment; patient and provider acceptability; and feasibility, equity and resource use

Setting

Outpatient

Perspective

Population level

Subgroups

High- or low-prevalence settings; settings with limited versus established laboratory capacity

Background

Syndromic management refers to a strategy for identifying and treating STIs based on specific syndromes (symptoms identified by a patient) and signs (clinically observed signs of infection) associated with clearly defined causes. Although etiological diagnosis is preferred, it is not always accessible or affordable.

Fig. A6.1 provides clinical guidelines for the syndromic management of genital ulcer syndrome in the 2003 guidelines for the management of sexually transmitted infections (1).

The Guideline Development Group agreed to update this approach for anogenital ulcers; ulcers are a break in the skin or mucosa and may present as ulcers, sores, or vesicles. Genital ulcers refer to those located on the genital or anorectal areas and may be painful or painless.

Assessment

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Summary of judgements

	Judgement
Problem	No	Probably no	Probably yes	Yes		Varies	Don’t know
Test accuracy	Very inaccurate	Inaccurate	Accurate	Very accurate		Varies	Don’t know
Desirable effects	Trivial	Small	Moderate	Large		Varies	Don’t know
Undesirable effects	Large	Moderate	Small	Trivial		Varies	Don’t know
Certainty of the evidence of test accuracy	Very low	Low	Moderate	High			No included studies
Certainty of the evidence of the effects of management	Very low	Low	Moderate	High			No included studies
Certainty of effects	Very low	Low	Moderate	High			No included studies
Values	Important uncertainty or variability	Possibly important uncertainty or variability	Probably no important uncertainty or variability	No important uncertainty or variability
Balance of effects	Favours the comparison	Probably favours the comparison	Does not favour either the intervention or the comparison	Probably favours the intervention	Favours the intervention	Varies	Don’t know
Resources required	Large costs	Moderate costs	Negligible costs and savings	Moderate savings	Large savings	Varies	Don’t know
Certainty of evidence of required resources	Very low	Low	Moderate	High			No included studies
Cost–effectiveness	Favours the comparison	Probably favours the comparison	Does not favour either the intervention or the comparison	Probably favours the intervention	Favours the intervention	Varies	No included studies
Equity	Reduced	Probably reduced	Probably no impact	Probably increased	Increased	Varies	Don’t know
Acceptability	No	Probably no	Probably yes	Yes		Varies	Don’t know
Feasibility	No	Probably no	Probably yes	Yes		Varies	Don’t know

Conclusions

Should current WHO syndromic management be recommended versus laboratory diagnosis, no treatment or treat all to identify sexually transmitted infections among people with anogenital ulcers?

Type of recommendation

●

Strong recommendation against the intervention

○

Conditional recommendation against the intervention

○

Conditional recommendation for either the intervention or the comparison

○

Conditional recommendation for the intervention

○

Strong recommendation for the intervention

Draft recommendation

Recommendations for management of genital ulcer disease, including anorectal ulcers

For people who present with genital ulcers (including anorectal ulcers), we recommend treatment based on quality-assured molecular assays of the ulcer. However, in settings with limited or no molecular tests or laboratory capacity, we recommend syndromic treatment to ensure treatment on the same day of the visit.

Good practice includes:

taking a medical and sexual history and assessing the risk of STIs;
performing a physical examination of the genital and anal areas;
offering HIV and syphilis testing and other preventive services as recommended in other guidelines; and
providing analgesics for pain.

Settings with quality-assured molecular testing in a laboratory with a fully operational quality management system and results available on the same day of the visit

For people with confirmed anogenital ulcers, we recommend to:

Perform molecular assays (NAAT) from anogenital lesions to confirm or exclude herpes simplex virus and Treponema pallidum (syphilis).
Perform molecular assays from anogenital lesions to confirm lymphogranuloma venereum in geographical settings and/or populations where cases are reported or emerging.
Perform serological tests for syphilis, with appropriate interpretation for management depending on the test or tests used.
Treat for syphilis and/or herpes simplex virus according to the results available on the same day of the visit or treat syndromically and revise management according to the results when available.
Treat for lymphogranuloma venereum when the results are positive.
Treat for chancroid only in geographical settings where cases are reported or emerging.

Settings in which same-day treatment is not feasible with molecular testing or with limited or no molecular testing

For people with confirmed anogenital ulcers, WHO suggests the following.

Treat syndromically for syphilis and herpes simplex virus on the same day.
Treat for herpes simplex virus if the ulcer is recurrent or vesicular, and treat for syphilis if the person has no history of recent treatment for syphilis (in the past three months).
Treat for chancroid only in geographical settings where cases are reported or emerging.

Good practice includes.

Performing serological tests for syphilis, including an RPR-equivalent test, if available, to attempt to identify active syphilis and for monitoring the response to treatment.

Referring men with persistent anogenital ulcers to a centre with laboratory capacity and expertise to diagnose herpes or less common pathogens (lymphogranuloma venereum, donovanosis and chancroid) and other genital or gastrointestinal conditions.

Remarks

Genital ulcer disease refers to breaks in the skin or mucosa and may present as ulcers, sores or vesicles. Anogenital ulcers refer to those located on the genital or anal areas and may be painful or painless.

A negative serological test for syphilis when anogenital ulcers have been present for less than three weeks does not definitively exclude syphilis, since antibodies may not yet be present to be detected by a serological test for syphilis. See WHO guidance on interpreting syphilis tests (see subsection 10.2).

Justification

Managing people presenting with anogenital ulcers based on a syndromic approach results in small benefits and moderate harms compared to molecular testing or treating all. Molecular testing may not be feasible in all settings and alternatively treating all would be feasible and the costs would be negligible. Treating all or conducting molecular testing would be acceptable to all and would not have a negative impact on equity (in some settings it may increase equity).

Fig. A6.1Current WHO syndromic approach to management of genital ulcers

References

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Table A6.1Detection of any STI for genital ulcer syndrome (shaded rows represents studies testing presence of ulcer to detect any STIs)

Study	Year of study	Country	Country income level	Sample size	Where recruited	Subpopulation	How a positive case is defined	Pathogens	Diagnostics	True positive	False negative	False positive	True negative
Das et al. (5)	2013	India	Lower middle	297	STI and gynaecology outpatients	22% male 12% genital ulcer disease	Presence of ulcer	HSV, Candida glabrata, cytomegalovirus, true positive	VDRL, TPHA, Smear, HSV-Ab	14	215	27	41
Liu et al. (6)	2003	China	Upper middle	55	Sexual health clinic	100% male 14% genital ulcer disease	Presence of ulcer	HSV, true positive, Haemophilus ducreyi	PCR, RPR, TPPA	13	0	40	2
Sanchez et al. (7)	1995–1996	Dominican Republic	Upper middle	81	General practice	100% male 100% genital ulcer disease	Symptoms + examination	HSV, true positive, Haemophilus ducreyi	M-PCR	13	12	28	28
Sanchez et al. (7)	1995–1996	Peru	Upper middle	63	General practice	100% male 100% genital ulcer disease	Symptoms + examination	HSV, true positive, Haemophilus ducreyi	M-PCR	2	7	29	25

Table A6.2Comparing the accuracy of clinical diagnosis of herpes with etiological diagnosis of herpes

Study	Year of study	Country	Country income level	Sample size	Where recruited	Subpopulation	How a positive case is defined	Diagnostics	True positive	False negative	False positive	True negative
Behets et al. (8)	1997	Madagascar	Low	196	Sexual health clinic	71% men	Clinical diagnosis^a	M-PCR	0	19	2	175
Behets et al. (9)	1996	Jamaica	Upper middle	304	Sexual Health clinic	83% men	Clinical diagnosis^a	M-PCR	85	73	24	122
Beyrer et al. (10)	1995–1996	Thailand	Upper middle	38	Sexual health clinic	79% female sex workers	Clinical diagnosis^a	M-PCR	21	11	3	3
Bhavsar et al. (11)	2011–2012	India	Lower middle	96	Hospital	79% men	Clinical diagnosis^a	Tzanck smear IgM for HSV-2	33	0	38	25
Bogaerts et al. (12)	1990–1992	Rwanda	Low	395	General practice	63% men	History and examination	Cytopathic effect on Vero cells	4	85	4	302
Bogaerts et al. (12)	1990–1992	Rwanda	Low	395	General practice	63% men	History and examination + syphilis serology or darkfield microscopy	Cytopathic effect on Vero cells	4	85	4	302
Bogaerts et al. (13)	1990–1992	Rwanda	Low	395	General practice	63% men	Clinical diagnosis^a	Cytopathic effect on Vero cells	43	46	87	219
DiCarlo & Martin (13)	1990–1992	United States	High	220	Sexual health clinic	100% men	Clinical diagnosis^a	Culture	20	37	10	153
Hina et al. (14)	2015–2016	India	Lower middle	96	Sexual health clinic	75% men	Clinical diagnosis^a	Tzanck smears, HSV2-IgM	33	2	36	25
Htun et al. (15)	1993–1994	Lesotho	Lower middle	92	Sexual health clinic		Clinical diagnosis^a	MPCR	7	10	1	74
Htun et al. (15)	1993–1994	Lesotho	Lower middle	92	Sexual health clinic		Clinical diagnosis^a	MPCR	5	19	3	65
Htun et al. (15)	1993–1994	Lesotho	Lower middle	92	Sexual health clinic		Clinical diagnosis^a	MPCR	0	24	0	68
Prabhakar et al. (16)	2008–2009	India	Lower middle	181	Sexual health clinic	100% men	Clinical diagnosis^a	M-PCR	59	31	37	54
Risbud et al. (17)	1994	India	Lower middle	302	Sexual health clinic		Clinical diagnosis^a	M-PCR	48	47	32	175
Sanchez et al. (7)	1995–1996	Dominican Republic	Upper middle	81	General practice	100% men	Clinical diagnosis^a	M-PCR	19	16	10	36
Sanchez et al. (7)	1995–1996	Peru	Upper middle	63	General practice	100% men	Clinical diagnosis^a	M-PCR	15	12	17	19
Wang et al. (18)	1998–1999	China	Upper middle	96	Sexual health clinic	52% men	Clinical diagnosis^a	M-PCR	25	8	36	27
Wang et al. (19)	2000–2001	China	Upper middle	227	Sexual health clinic	90% men	Clinical diagnosis^a	M-PCR	49	22	78	78
Fast et al. (20)	1980	Kenya	Lower middle	70	“Special treatment clinic”	100% men	Clinical diagnosis^a	Culture	3	3	1	63
Dangor et al. (21)	Unclear	South Africa	Upper middle	210	Hospital	100% men	Clinical diagnosis^a	Culture	5	2	21	182

a: A diagnostic test is the clinician’s diagnosis of herpes (rather than the presence of an ulcer). Clinical diagnosis is based on physical examination and history.

Table A6.3Detection of syphilis using clinical diagnosis of syphilis in a population of individuals with genital ulcer disease

Study	Year of study	Country	Country income level	Sample size	Where recruited	Subpopulation	How a positive case is defined	Diagnostics	True positive	False negative	False positive	True negative
Behets et al. (8)	1997	Madagascar	Low	196	Sexual health clinic	71% men	Clinical diagnosis^a	M-PCR	52	4	112	28
Behets et al. (9)	1996	Jamaica	Upper middle	304	Sexual Health clinic	83% men	Clinical diagnosis^a	M-PCR	21	10	24	249
Beyrer et al. (10)	1995–1996	Thailand	Upper middle	38	Sexual health clinic	79% female sex workers	Clinical diagnosis^a	M-PCR	0	1	1	36
Bhavsar et al. (11)	2011–2012	India	Lower middle	96	Hospital	79% men	Clinical diagnosis^a	VDRL, TPHA	19	24	1	52
Bogaerts et al. (12)	1990–1992	Rwanda	Low	395	General practice	63% men	History and examination	RPR, TPHA, Darkfield microscopy	108	2	279	6
Bogaerts et al. (12)	1990–1992	Rwanda	Low	395	General practice	63% men	History and examination + syphilis serology or darkfield microscopy	RPR, TPHA, Darkfield microscopy	107	3	9	276
Bogaerts et al. (12)	1990–1992	Rwanda	Low	395	General practice	63% men	Clinical diagnosis^a	RPR, TPHA, Darkfield microscopy	20	90	31	254
DiCarlo & Martin (13)	1990–1992	United States	High	220	Sexual health clinic	100% men	Clinical diagnosis^a	Darkfield microscopy	14	31	3	172
Hanson et al. (22)	1996	Zambia	Lower middle	95	Hospital	100% men	Clinical diagnosis^a	Darkfield microscopy, RPR, TPHA	24	17	14	40
Hanson et al. (22)	1996	Zambia	Lower middle	131	Hospital	100% women	Clinical diagnosis^a	Darkfield microscopy, RPR, TPHA	14	22	12	83
Htun et al. (15)	1993–1994	Lesotho	Lower middle	92	Sexual health clinic		Clinical diagnosis^a	MPCR, RPR, FTA-Abs	5	18	1	68
Htun et al. (15)	1993–1994	Lesotho	Lower middle	92	Sexual health clinic		Clinical diagnosis^a	MPCR, RPR, FTA-Abs	30	4	52	6
Htun et al. (15)	1993–1994	Lesotho	Lower middle	92	Sexual health clinic		Clinical diagnosis^a	MPCR, RPR, FTA-Abs	33	1	52	6
Ndinya-Achola et al. (23)	1990–1991	Kenya	Lower middle	172	Primary care	47% men	Clinical diagnosis^a	RPR	6	18	19	129
Prabhakar et al. (16)	2008–2009	India	Lower middle	181	Sexual health clinic	100% men	Clinical diagnosis^a	M-PCR	26	18	72	78
Sanchez et al. (7)	1995–1996	Dominican Republic	Upper middle	81	General practice	100% men	Clinical diagnosis^a	M-PCR	2	2	11	66
Sanchez et al. (7)	1995–1996	Dominican Republic	Upper middle	63	General practice	100% men	Clinical diagnosis^a	M-PCR	2	4	8	49
Wang et al. (18)	1998–1999	China	Upper middle	96	Sexual health clinic	100% had “STI symptoms”	Clinical diagnosis^a	M-PCR, RPR, TPPA	18	5	12	61
Wang et al. (19)	2000–1	China	Upper middle	227	Sexual health clinic	90% men	Symptoms + examination + risk factors	M-PCR, Darkfield microscopy, RPR, TPPA	94	12	6	115
Fast et al. (20)	1980	Kenya	Lower middle	70	“Special treatment clinic”	100% men	Clinical diagnosis^a	RPR, Darkfield microscopy	6	4	4	56
Dangor et al. (21)	Unclear	South Africa	Upper middle	210	Hospital	100% male	Clinical diagnosis^a	RPR, fluorescent treponemal antibody absorption, darkfield microscopy	22	3	25	160

a: A diagnostic test is the clinician’s diagnosis of herpes (rather than the presence of an ulcer). Clinical diagnosis is based on physical examination and history.

Table A6.4Detection of chancroid using clinical diagnosis of chancroid in a population with genital ulcer disease

Study	Year of study	Country	Country income level	Sample size	Where recruited	Subpopulation	How a positive case is defined	Diagnostics	True positive	False negative	False positive	True negative
Behets et al. (8)	1997	Madagascar	Low	196	Sexual health clinic	71% men 100% genital ulcer disease	Clinical diagnosis^a	M-PCR	34	30	63	69
Behets et al. (9)	1996	Jamaica	Upper middle	304	Sexual Health clinic	83% men 100% genital ulcer disease	Clinical diagnosis^a	M-PCR	54	18	57	175
Beyrer et al. (10)	1995–1996	Thailand	Upper middle	38	Sexual health clinic	79% female sex workers 100% genital ulcer disease	Clinical diagnosis^a	M-PCR	0	0	6	32
Bhavsar et al. (11)	2011–2012	India	Lower middle	96	Hospital	79% men 100% genital ulcer disease	Clinical diagnosis^a	Gram stain	2	1	1	92
Bogaerts et al. (12)	1990–1992	Rwanda	Low	395	General practice	63% men 100% genital ulcer disease	History and examination	Culture	115	0	272	8
Bogaerts et al. (12)	1990–1992	Rwanda	Low	395	General practice	63% men 100% genital ulcer disease	History and examination + syphilis serology or darkfield microscopy	Culture	83	32	188	92
Bogaerts et al. (12)	1990–1992	Rwanda	Low	395	General practice	63% men 100% genital ulcer disease	Clinical diagnosis^a	Culture	74	41	67	213
DiCarlo & Martin (13)	1990–1992	USA	High	220	Sexual health clinic	100% men 100% genital ulcer disease	Clinical diagnosis^a	Culture	40	78	6	96
Htun et al. (15)	1993–1994	Lesotho	Lower middle	92	Sexual health clinic	100% genital ulcer disease	Clinical diagnosis^a	MPCR	54	2	22	14
Htun et al. (15)	1993–1994	Lesotho	Lower middle	92	Sexual health clinic	100% genital ulcer disease	Clinical diagnosis^a	MPCR	51	4	31	6
Htun et al. (15)	1993–1994	Lesotho	Lower middle	92	Sexual health clinic	100% genital ulcer disease	Clinical diagnosis^a	MPCR	53	3	32	4
Ndinya-Achola et al. (23)	1990–1991	Kenya	Lower middle	156	Primary care	47% men 100% genital ulcer disease	Clinical diagnosis^a	Culture	51	5	76	24
Prabhakar et al. (16)	2008–2009	India	Lower middle	181	Sexual health clinic	100% men 100% genital ulcer disease	Clinical diagnosis^a	M-PCR	59	31	37	54
Risbud et al. (17)	1994	India	Lower middle	302	Sexual health clinic	100% genital ulcer disease	Clinical diagnosis^a	M-PCR	53	31	76	142
Sanchez et al. (7)	1995–1996	Dominican Republic	Upper middle	81	General practice	100% men 100% genital ulcer disease	Clinical diagnosis^a	M-PCR	11	10	17	43
Sanchez et al. (7)	1995–1996	Peru	Upper middle	63	General practice	100% men 100% genital ulcer disease	Clinical diagnosis^a	M-PCR	0	3	21	39
Fast et al. (20)	1980	Kenya	Lower middle	70	“Special treatment clinic”	100% men 100% genital ulcer disease	Clinical diagnosis^a	Culture	42	6	8	14
Dangor et al. (20)	Unclear	South Africa	Upper middle	210	Hospital	100% genital ulcer disease	Clinical diagnosis^a		117	30	14	49

a: A diagnostic test is the clinician’s diagnosis of herpes (rather than the presence of an ulcer). Clinical diagnosis is based on physical examination and history.

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Guidelines for the management of symptomatic sexually transmitted infections [Internet]. Geneva: World Health Organization; 2021 Jun. ANNEX 6, EVIDENCE-TO-DECISION TABLE: GENITAL ULCER DISEASE.
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Should current WHO syndromic management be recommended versus laboratory diagnosis, no treatment or treat all to identify sexually transmitted infections among people with anogenital ulcers?
Assessment
Summary of judgements
Conclusions

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EVIDENCE-TO-DECISION TABLE: GENITAL ULCER DISEASE - Guidelines for the managemen...
EVIDENCE-TO-DECISION TABLE: GENITAL ULCER DISEASE - Guidelines for the management of symptomatic sexually transmitted infections
Intranuclear Inclusion Bodies
Intranuclear Inclusion Bodies
Circumscribed masses of foreign or metabolically inactive materials, within the CELL NUCLEUS. Some are VIRAL INCLUSION BODIES.<br/>Year introduced: 2004
MeSH
Sarcolemma
Sarcolemma
The excitable plasma membrane of a muscle cell. (Glick, Glossary of Biochemistry and Molecular Biology, 1990)<br/>Year introduced: 1972(1967)
MeSH
Intracellular Membranes
Intracellular Membranes
Thin structures that encapsulate subcellular structures or ORGANELLES in EUKARYOTIC CELLS. They include a variety of membranes associated with the CELL NUCLEUS; the MITOCHONDR...<br/>Year introduced: 1979
MeSH
Stereocilia
Stereocilia
Mechanosensing organelles of hair cells which respond to fluid motion or fluid pressure changes. They have various functions in many different animals, but are primarily used ...<br/>Year introduced: 2012
MeSH

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Guidelines for the management of symptomatic sexually transmitted infections [Internet].

ANNEX 6EVIDENCE-TO-DECISION TABLE: GENITAL ULCER DISEASE

Should current WHO syndromic management be recommended versus laboratory diagnosis, no treatment or treat all to identify sexually transmitted infections among people with anogenital ulcers?

Population

Intervention and comparator

Purpose of the approach

Linked treatments

Anticipated outcomes

Setting

Perspective

Subgroups

Background

Assessment

Summary of judgements

Conclusions

Should current WHO syndromic management be recommended versus laboratory diagnosis, no treatment or treat all to identify sexually transmitted infections among people with anogenital ulcers?

Fig. A6.1Current WHO syndromic approach to management of genital ulcers

References

Table A6.1Detection of any STI for genital ulcer syndrome (shaded rows represents studies testing presence of ulcer to detect any STIs)

Table A6.2Comparing the accuracy of clinical diagnosis of herpes with etiological diagnosis of herpes

Table A6.3Detection of syphilis using clinical diagnosis of syphilis in a population of individuals with genital ulcer disease

Table A6.4Detection of chancroid using clinical diagnosis of chancroid in a population with genital ulcer disease

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