Symptom triggered screening for ovarian cancer: A pilot study of feasibility and acceptability

Abstract

Purpose Our goal was to determine if symptom-based ovarian cancer screening was feasible in a primary care clinic and acceptable to women and practitioners. In addition, we wanted to describe the outcomes for a pilot group of screened women. Methods A prospective study of 2262 women over age 40 with at least one ovary participated in symptom-based screening using a symptom index (SI). The first 1001 were in a non-intervention study arm and 1261 were screened for symptoms and referred on to testing with CA125 and transvaginal ultrasound (TVS) if the SI result was positive. Patients and practitioners were surveyed about acceptability of study procedures. All patients were linked to the Western Washington SEER Cancer Registry to determine if ovarian cancer was diagnosed in any women. Results Of the eligible women visiting the clinic, 72.5% were interested in participating, and the participation rate was 62.1%. Of the 1261 who participated in the screening arm 51(4%) were SI positive and 47 participated in CA125 (45/47 normal) and TVS (32/47 normal). Two endometrial biopsies and one hysteroscopy D&C were performed secondary to study enrollment (pathology negative). No laparotomies or laparoscopies were performed secondary to study involvement. A survey of patient acceptability, on a scale of 1–5, revealed a mean score of 4.8 for the acceptability of SI screening and 4.7 for TVS and CA125 testing among SI positive women. Providers also rated the SI procedures highly acceptable with a mean score of 4.8. Two participating patients were diagnosed with ovarian cancer; one had a true positive SI in the non-intervention arm and one had a false negative SI in the screened arm. Conclusion While our pilot study is not large enough to assess sensitivity or specificity of a symptom-based screening approach, we did find that this type of screening was feasible and acceptable at the time of a primary care visit and referred approximately 4% of women for additional diagnostic testing. Symptom-based screening also resulted in minimal additional procedures.

Value of Symptom-Triggered Diagnostic Evaluation for Ovarian Cancer

“…Women with abnormal results on these tests were managed according to standard of care by their physicians consistent with earlier studies. 9 CA125 was considered normal if less than 35 U/ml. All transvaginal ultrasounds were performed in the radiology department at the clinic by a trained sonographer and radiologist as they would be for routine clinical care.…”

“…Approximately a year (June 2012) after study completion, all participant names (positive and negative SI) were linked to the Western Washington Surveillance, Epidemiology, and End Results (SEER) database to assess if any of the participants developed ovarian cancer, as had been done in our pilot study 9 . Sufficient time was allowed to be certain that all ovarian cancer cases were captured.…”

“…9 The goal of our current study was to evaluate the potential harms (unnecessary surgery and testing) and ovarian cancer outcomes associated with proactively assessing symptoms with a Symptom Index followed up with routine referral for diagnostic testing.…”

Validación de un instrumento para detectar síntomas indicativos de cáncer de ovario en Querétaro, México

“…Estudios recientes, así como diversos autores sugieren que al identificar a las mujeres con síntomas indicativos de CaOva, mas el uso de biomarcador como el CA 125 y el Ultrasonido transvaginal (USTV) (13) hacen referencia a que se debe preguntar la frecuencia con que estos se presentan (15)(16)(17)(18) . Con el coste de los actuales métodos de diagnostico y con la necesidad de desarrollar una herramienta especifica que nos funcione como método de tamizaje para identificar a mujeres con riesgo y aplicarles las pruebas pertinente se propone el instrumento "Diagnostico Oportuno de…”

Development of an instrument to identify symptoms potentially indicative of ovarian cancer in a primary care clinic setting

“…Two recent prospective studies suggest that efforts to identify women with symptoms and assure prompt assessment for ovarian cancer using currently available tests (CA-125 and TVS) could result in earlier diagnosis of ovarian cancer [1,2]. Consistent with evidence to suggest that women with ovarian cancer present with symptoms, even when the disease is in its early stages [3][4][5][6][7][8], and advice from the Gynecologic Cancer Foundation, the Society of Gynecologic Oncologists and the American Cancer Society [9], and a statement by NICE (National Institute for Health and Clinical Excellence) [10] encouraging follow-up of women reporting symptoms.…”