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Cross-sectional diagnostic accuracy study of self-testing for proteinuria during hypertensive pregnancies: The UDIP study

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Bethany Ellen Jakubowski, Richard Stevens, Hannah Wilson, Layla Lavallee, Lesley Brittain, Carole Crawford, James Hodgkinson, Lisa Hinton, Lucy Mackillop, Lucy C. Chappell, Richard J. McManus, Katherine Louise Tucker

Original languageEnglish
Pages (from-to)2142-2148
Number of pages7
JournalBJOG: An International Journal of Obstetrics and Gynaecology
Volume129
Issue number13
DOIs
Accepted/In press2022
PublishedDec 2022

Bibliographical note

Funding Information: The authors would like to acknowledge the work and support of the team who conducted the recruitment: Rachel Woodcock, Hayley Tarft, Alice Lewin and Fenella Roseman. We would like to thank Tim James at the John Radcliffe Hospital for laboratory support. We would like to thank Marcus Green from Action on Pre-eclampsia for support with the PPI work. We would like to thank Lucy Curtin for admin support. This work would not have been possible without the support of many research midwives, supportive NHS staff and the women who participated at: Oxford University Hospitals NHS Foundation Trust, Guy’s and St Thomas’s NHS Foundation Trust, and Birmingham Women’s and Children’s NHS Foundation Trust. We thank all who were involved. Funding Information: This work was funded by a National Institute for Health Research (NIHR) programme grant for applied research (Optimising the monitoring and management of raised blood pressure during and after pregnancy, RP‐PG‐0614‐20 005) and an NIHR Professorship awarded to RM (NIHR‐RP‐R2‐12‐015). RM, KT and BJ received funding from the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research (CLAHRC), now recommissioned as NIHR Applied Research Collaboration Oxford and Thames Valley (ARC‐OxTV). BJ also received funding from the Primary Care Research Trust. LH is based in The Healthcare Improvement Studies Institute (THIS Institute), University of Cambridge. THIS Institute is supported by the Health Foundation, an independent charity committed to bringing about better health and healthcare for people in the UK. LH received additional funding from the NIHR Oxford Biomedical Research Centre. LM is supported by the NIHR Oxford Biomedical Research Centre. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. Publisher Copyright: © 2022 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.

King's Authors

Abstract

Objective: To determine the accuracy of self-testing for proteinuria during pregnancy. Design: Diagnostic accuracy study. Setting: Antenatal clinics, maternity assessment units and inpatient wards at three hospital sites. Population or Sample: 345 pregnant women. Methods: Pregnant women self-tested in-clinic for urinary protein using visually read dipsticks with samples then sent for laboratory estimation of the spot protein-creatinine ratio (PCR) (primary reference test). Secondary index tests included testing by antenatal healthcare professionals and an automated colorimetric reader. Main outcome measures: Sensitivity, specificity, negative predictive value, positive predictive value and likelihood ratios were calculated for self-testing (primary index test) along with healthcare professional and colorimetric testing compared to the primary reference test (PCR). Results: 335/345 (97%) had sufficient data to be included in the analysis. Self-testing had a sensitivity of 0.71 (95% confidence interval [CI] 0.62–0.79) and a specificity of 0.89 (95% CI 0.84–0.92) compared to PCR. Sensitivity and specificity of testing by healthcare professionals and the colorimetric reader were similar: sensitivity 0.73 (95% CI 0.64–0.80) and 0.78 (95% CI 0.69–0.85), respectively; specificity 0.88 (95% CI 0.82–0.92) and 0.83 (95% CI 0.78–0.88), respectively. Conclusion: Pregnant women can visually read a dipstick for urinary protein with similar accuracy to antenatal healthcare professionals. Automated colorimetric testing was not significantly different, in contrast to some previous studies. Self-testing has the potential to form part of a self-monitoring regime in pregnancy.

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