TY - JOUR
T1 - The Diagnostic Accuracy of Syndromic Management for Genital Ulcer Disease
T2 - A Systematic Review and Meta-Analysis
AU - Loh, Andre J.W.
AU - Ting, Ee Lynn
AU - Wi, Teodora E.
AU - Mayaud, Philippe
AU - Chow, Eric P.F.
AU - Santesso, Nancy
AU - Falconer, Jane
AU - Ofori-Asenso, Richard
AU - Ong, Jason J.
N1 - Funding Information:
The World Health Organization funded the study and helped with the study design, analysis, interpretation of data, writing of the report, and the decision to submit the paper for publication. JO and EC were supported by the Australian National Health and Medical Research Council (NHMRC) Emerging Leadership Investigator Grant (GNT1193955 and GNT1172873).
Publisher Copyright:
Copyright © 2022 Loh, Ting, Wi, Mayaud, Chow, Santesso, Falconer, Ofori-Asenso and Ong.
PY - 2022/1/3
Y1 - 2022/1/3
N2 - Objectives: Genital Ulcer Disease (GUD) carries a significant disease burden globally. With limited access to diagnostics, the 2001 World Health Organization (WHO) sexually transmitted illnesses (STI) guidelines proposed a syndromic management algorithm that required a clinical decision to determine the management of GUD. We assessed the diagnostic accuracy of this algorithm. Methods: We conducted a systematic review (Prospero: CRD42020153294) using eight databases for publications between 1995 and January 2021 that reported primary data on the diagnostic accuracy of clinical diagnosis to identify aetiological agents of GUD. Titles and abstracts were independently assessed for eligibility, and data were extracted from full texts for sensitivity/specificity. A hierarchical logistic regression model was used to derive pooled sensitivity and specificity. We used GRADE to evaluate the certainty of evidence. Results: Of 24,857 articles, 151 full texts were examined and 29 included in the analysis. The majority were from middle-income countries [(14/29 (48%) lower middle, 10/29 (34%) upper middle)]. We pooled studies where molecular testing was using to confirm the aetiology of GUD: 9 studies (12 estimates) for herpes, 4 studies (7 estimates) for syphilis, and 7 studies (10 estimates) for chancroid. The pooled sensitivity and specificity of GUD for the detection of herpes was 43.5% [95% confidence interval (CI): 26.2–62.4], and 88.0% (95% CI: 67.0–96.3), respectively (high certainty evidence); and for syphilis were 52.8% (95% CI: 23.0–80.7), and 72.1% (95% CI: 28.0–94.5) (moderate certainty evidence); and for chancroid were 71.9% (95% CI: 45.9–88.5) and 53.1% (95% CI: 36.6–68.9) (moderate certainty evidence), respectively. Conclusion: Algorithms requiring a clinical diagnosis to determine and treat the aetiology of GUD have poor sensitivities for syphilis and herpes simplex virus, resulting in significant numbers of missed cases. There is an urgent need to improve access to affordable and efficient diagnostics (e.g., point-of-care tests) to be incorporated into GUD algorithms to better guide appropriate management. Systematic Review Registration: PROSPERO, identifier: CRD42020153294.
AB - Objectives: Genital Ulcer Disease (GUD) carries a significant disease burden globally. With limited access to diagnostics, the 2001 World Health Organization (WHO) sexually transmitted illnesses (STI) guidelines proposed a syndromic management algorithm that required a clinical decision to determine the management of GUD. We assessed the diagnostic accuracy of this algorithm. Methods: We conducted a systematic review (Prospero: CRD42020153294) using eight databases for publications between 1995 and January 2021 that reported primary data on the diagnostic accuracy of clinical diagnosis to identify aetiological agents of GUD. Titles and abstracts were independently assessed for eligibility, and data were extracted from full texts for sensitivity/specificity. A hierarchical logistic regression model was used to derive pooled sensitivity and specificity. We used GRADE to evaluate the certainty of evidence. Results: Of 24,857 articles, 151 full texts were examined and 29 included in the analysis. The majority were from middle-income countries [(14/29 (48%) lower middle, 10/29 (34%) upper middle)]. We pooled studies where molecular testing was using to confirm the aetiology of GUD: 9 studies (12 estimates) for herpes, 4 studies (7 estimates) for syphilis, and 7 studies (10 estimates) for chancroid. The pooled sensitivity and specificity of GUD for the detection of herpes was 43.5% [95% confidence interval (CI): 26.2–62.4], and 88.0% (95% CI: 67.0–96.3), respectively (high certainty evidence); and for syphilis were 52.8% (95% CI: 23.0–80.7), and 72.1% (95% CI: 28.0–94.5) (moderate certainty evidence); and for chancroid were 71.9% (95% CI: 45.9–88.5) and 53.1% (95% CI: 36.6–68.9) (moderate certainty evidence), respectively. Conclusion: Algorithms requiring a clinical diagnosis to determine and treat the aetiology of GUD have poor sensitivities for syphilis and herpes simplex virus, resulting in significant numbers of missed cases. There is an urgent need to improve access to affordable and efficient diagnostics (e.g., point-of-care tests) to be incorporated into GUD algorithms to better guide appropriate management. Systematic Review Registration: PROSPERO, identifier: CRD42020153294.
KW - chancroid
KW - genital ulcer disease
KW - herpes
KW - syndromic algorithm
KW - syphilis
KW - systematic review and meta-analysis
UR - http://www.scopus.com/inward/record.url?scp=85123257308&partnerID=8YFLogxK
U2 - 10.3389/fmed.2021.806605
DO - 10.3389/fmed.2021.806605
M3 - Review Article
C2 - 35071282
AN - SCOPUS:85123257308
SN - 2296-858X
VL - 8
JO - Frontiers in Medicine
JF - Frontiers in Medicine
M1 - 806605
ER -