Direct access from general practice to transvaginal ultrasound for early detection of ovarian cancer: a feasibility study

Abstract

Objective

To investigate the feasibility of providing general practitioners (GPs) direct and fast referral access to transvaginal ultrasound (TVUS).

Design

A prospective cohort study.

Setting

A total of 232 Danish general practices in parts of the Central Denmark Region.

Subjects

Women aged ≥40 years who consulted their GP for vague and non-specific symptoms (n = 479).

Main outcome measures

The feasibility assessment included the GPs’ referral rate, indications for referral, management of test results, and findings from TVUS.

Results

A total of 479 women were referred to TVUS. The examinations revealed abnormalities in 104 (21.7%) women. Additional investigations were needed in 68 (14.2%) women of whom seven (1.5%) underwent major surgery. No case of ovarian cancer was diagnosed during the study period or the 6-month follow-up. However, three (0.6%) women with an abnormal transvaginal ultrasound were diagnosed with urogynecological cancer; this yielded a PPV of 4.4% (95% confidence interval: 1.5–12.2) and an NPV of 100.0% (95% confidence interval: 96.7–100.0) for urogynecological cancer.

Conclusion

Providing GPs with direct access to transvaginal ultrasound was feasible; 80% of the investigated women were referred back to the GP, 14% were further investigated, 0.6% were diagnosed with urogynecological cancer, and 1.5% had major procedures performed without complications.

Implications

Direct access to TVUS could be an important pathway to ensure fast evaluation of women presenting with vague non-specific symptoms of potential ovarian cancer. Future studies should explore the patient experience, cancer outcomes, and health economics issues.

KEY POINTS

•    Current awareness  • GPs have no fast referral option for women presenting with vague non-specific symptoms that could indicate underlying ovarian cancer.   Key findings  • We offered GPs direct and fast referral access to TVUS; 51.7% of practices used the opportunity.  • The GPs referred 479 women to TVUS; 104 had an abnormal TVUS and 68 needed additional investigations.  • Seven women underwent major surgery, leading to three cases of urogynecological cancer. No woman had a false negative TVUS result.

Keywords:

• Denmark
• early diagnosis
• general practice
• ovarian neoplasms
• ultrasonography

Ethical approval

All included patients signed a written consent form. According to the Committee on Health Research Ethics in the Central Denmark Region, the study did not require their approval (file no. 42/2016). The project (ID: 165) is registered in the Record of Processing Activities at the Research Unit for General Practice in Aarhus in accordance with the provisions of the General Data Protection Regulation (GDPR). The study was registered at ClinicalTrials.gov (identifier: NCT03069872).

Acknowledgements

We want to thank Alina Zalounina Falborg for statistical support, Lone Niedziella for language revision and Kaare Rud Flarup for helping with the initial data management. We thank the Department of Gynaecology and Obstetrics at Aarhus University Hospital, especially chief physician Jannie Dalby Salvig, gynecologist Katrine Fuglsang, the sonographers performing the TVUS, and secretary Heidi Jeppesen Hjort. We also thank the Department of Gynaecology and Obstetrics at Randers Regional Hospital, especially chief physician Eva Kleberg Andersen, gynecologist Maria Stentebjerg Skøtt, and the nurses and secretaries. Furthermore, we thank the Joint Unit for Gynecological Referrals in the Central Denmark Region, especially head medical secretary Dorte Lund Jensen for important contributions to the study.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

The study was supported by the Central Denmark Region (clinical support), Aarhus University, the Danish Foundation for Primary Health Care Research, the Danish Cancer Society, and by the CanTest Collaborative, which is funded by a Population Research Catalyst Award provided by Cancer Research UK [C8640/A23385]. The funding bodies were not involved in the conception of the study, writing of the manuscript, or analysing and interpreting the results. WH is director and PV is an associate director of the multi-institutional CanTest Research Collaborative.