Economic Evaluation of Three Populational Screening Strategies for Cervical Cancer in the County of Valles Occidental: CRICERVA Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 20,994
- Locations
- 1
- Primary Endpoint
- Clinical effectiveness measures
Study Overview
Brief Summary
The aim of this study was to compare the effectiveness and the costs of three types of population interventions to increase the number of female participants in the screening programmes for cancer of the cervix carried out by Primary Care in four Basic Health Care Areas.
Detailed Description
Background A high percentage of cervical cancer cases have not undergone cytological tests within 10 years prior to diagnosis. Different population interventions could improve coverage in the public system, although costs will also increase. The aim of this study was to compare the effectiveness and the costs of three types of population interventions to increase the number of female participants in the screening programmes for cancer of the cervix carried out by Primary Care in four basic health care areas.
Methods A cost-effectiveness analysis will be performed from the perspective of public health system including women from 30 to 70 years of age (n=20,994) with incorrect screening criteria from four basic health care areas in the Valles Occidental, Barcelona, Spain. The patients will be randomly distributed into the control group and the three Intervention Groups (IG1: invitation letter to participate in the screening; IG2: invitation letter and informative leaflet; IG3: invitation letter, informative leaflet and a phone call reminder) and followed for three years. Clinical effectiveness will be measured by the number of Human Papillomavirus (HPV), epithelial lesions and cancer of cervix cases detected. The number of deaths avoided will be secondary measures of effectiveness. The temporal horizon of the analysis will be the life expectancy of the female population in the study. Costs and effectiveness will be discounted at 3 %. In addition, univariate and multivariate sensitivity analysis will be carried out.
Expected results IG3 is expected to be more cost-effective intervention than IG1 and IG2, with greater detection of HPV infections, epithelial lesions and cancer than other strategies, albeit at a greater cost.
METHODS
An economic evaluation of three populational screening strategies for cervical cancer will be performed. Particularly, a cost-effectiveness analysis will be conducted. These interventions will be compared to the current opportunistic screening strategy using data of the multicentre randomised trial (CRICERVA). The analysis will be conducted from the National Health Care System perspective.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •20,994 women from 30 to 70 years of age with incorrect screening criteria (data obtained from Electronic Medical Records) ascribed to the Basic Health Care Area will be included in the study. Incorrect screening will be defined as [9]:
- •No cytology in the last 3 years from women between 30 to 40 years,
- •No cytology in the previous 5 years from women between 40 to 65 years,
- •No previous cytology history for females older than 65 years or women who have not had their last cytology before the age of 60
Exclusion Criteria
- •hysterectomised women, with a current history of pre-malignant lesions (Atypical glandular cells of undetermined significance, Atypical squamous cells of undetermined significance, Low grade Squamous Intraepithelial Lesion, High grade Squamous Intraepithelial Lesion), carcinoma in situ and cervical-uterine cancer, HIV positive or other causes of immunosuppression (since these women follow a specific protocol);
- •those residing outside the study setting for more than 6 months;
- •those ascribed to the study Basic Health Care Area but with a physician assigned in an UBA (General Practicioner and Nurse Team) of another zone different from the one considered in the study
Outcomes
Primary Outcomes
Clinical effectiveness measures
Time Frame: Third year
The main effectiveness measures of this evaluation would be the total number of cytologies performed, HPV infections detected, lesions of different grades detected, episodes of cancer detected and the number of deaths avoided
Costs measures
Time Frame: Third year
Include costs of diagnosis, interventions and treatment for all women * Diagnosis: cost of cytology, HPV determination test and control visit by the midwife or gynaecologist * Interventions: cost of a full-time administrator, personalized screening invitation letters, informative leaflets and phone calls * Treatment: will depend on the state of health of the women but may include the costs of the visits to the gynaecologist, cytology tests, HPV determination, control visits with the physician, costs of radical hysterectomy, radiotherapy, chemotherapy, etc
Secondary Outcomes
No secondary outcomes reported