Data for: Expert review of images from hand-held colposcopy in Zambian women with genital schistosomiasis – User Guide

Permanent identifier

https://doi.org/10.17037/DATA.00003182

Alternative title

The short title is “Data for: Expert review of hand-held colposcopy for visual-FGS”

Description

Female genital schistosomiasis (FGS) can occur in the setting of urinary S. haematobium infection, a neglected tropical disease associated with poverty, inadequate sanitation, and limited access to safe drinking water. Confirming a diagnosis of FGS is challenging as there is not a widely accepted diagnostic reference standard for research, diagnosis, and screening. A 2011 expert-led consensus meeting proposed visual inspection of the cervicovaginal mucosa as an adequate reference standard for FGS diagnosis. However, the mucosal changes in visual-FGS are non-specific and have also been associated with bacterial STI, human papillomavirus (HPV) infection, and cervical pre-cancer. Since cervicovaginal visualization is widely promoted for FGS screening and diagnosis, we wished to further evaluate the inter-rater reliability, correlation, and agreement of human expert reviewers in visual-FGS.

Data collection methods

The home visit included assessment of eligibility, a questionnaire, genital self-sampling (cervical and vaginal) and a single urine specimen. Questionnaire data were captured on tablets using Open Data Kit.

Classification: Interview: face-to-face

Data analysis and preparation

The primary analysis evaluated the association of agreement and inter-rater reliability between two human expert reviewers using Cohen’s Kappa statistic. Logistic regression was used to compare the exposure with the outcome in secondary aims (visual-FGS (exposure) and abdominal, genitourinary, and reproductive manifestations (outcomes); various diagnostic tests to evaluate urinary Schistosoma infection (CAA and urine microscopy), and FGS (portable colposcopy, and Schistosoma DNA on CVL and genital swabs) [exposure] with visual-FGS (outcome).

Geographic region

Key dates

• Data collection period: 8 January 2018 - 31 August 2018
• Dataset prepared for repository: November 15 2022

Quality controls

Prior to data collection: The protocol and study methodology were sent for peer review and approved by LSHTM and Zambian ethics committees to ensure the data would be fit for study needs. Queries from both ethics committees were incorporated into the final protocol. The questionnaire was piloted locally to obtain feedback regarding the acceptability of the content. Training was provided to all staff members. Questionnaires are designed with dual-data entry functions, date widgets, and “relevant”/ “constraint” coding functions to minimize errors in data entry.

During Data Collection: Data entry was performed by trained study staff. Regular site visits occurred and staff were observed performing all aspects of data collection and data entry. The project lead, study managers, and PI offer regular oversight regarding best practices in data collection. Data were also regularly reviewed for irregularities to confirm the correct information was collected and that the data were of sufficient quality. During data analysis the data were reviewed regularly to ensure that processing tasks did not cause any problems.

Population

Women living in Livingstone, Zambia where S. haematobium is endemic.

Privacy

Any participants’ identifiable data collected has been stored securely and their confidentiality protected in accordance with the Data Protection Act 1998. Home visits were conducted in private. Data collected in home and clinic visits were be entered on an encrypted ODK electronic device and were then uploaded to a secure LSHTM server.

Ethics

Keywords

Female genital schistosomiasis, Schistosoma haematobium, hand-held colposcopy, visual-FGS

Language of written material

English

Project information

Creators

Research group

File description