Prostate-Specific Antigen Clinical Trial
Official title:
Study of the Adequacy of the Requests of Prostate-Specific Antigen (PSA), Factors Associated With the False Negative and Positive Results and the Impact on Patient's Health
Objectives.
The primary aim of this study is to evaluate the characteristics of the determination of PSA
for the early detection of prostate cancer or in the presence of symptoms, in general
practice in two health departments of the Valencian Community (Spain).
Specific objectives:
- To describe the PSA determinations that are performed in clinical practice, with the
exception of patients with prostate cancer or who are being followed for previous high
PSA values.
- To study the adequacy of PSA requests according to the available recommendations,
considering sociodemographic and clinical aspects of the patient, such as the time
interval since the last PSA test.
The investigators will randomly select patients from the Health Departments 17 and 19, in the
Valencian Community (Spain) with a PSA request from Primary health centres.
Sample size and recruitment procedure:
During the last semester of 2016, 9,963 PSA determinations were carried out at Sant Joan
d'Alacant Hospital and a similar number at Alicante General Hospital. Primary health centres
requested most determinations. The prevalence of prostate cancer in 2012 was 527.3/100,000
men in Spain. Considering that there are about 120,000 men in each of the included
Departments of Health, approximately 630 men will have the diagnosis of prostate cancer in
each of them.
According to the established recommendations, a patient with prostate cancer had a PSA
determination every 3-6 months. Consequently, 1,260 determinations per centre would
correspond to prostate cancer patients each 6 months. Therefore, the investigators would have
in each department approximately 8,740 determinations of patients without prostate cancer,
and therefore, possible candidates to enter in our study.
According to a pilot study with 360 patients in which 35.6% of the requested PSA
determinations do not follow the available recommendations with a 95% margin of error and 2%
accuracy, the investigators will include a total of 1,410 determinations from the two
centres. Hence, for the determination of specific objective 1, the investigators will select
a random sample of 705 patients with a PSA determination in each centre.
From each clinical analysis laboratory, the investigators will randomly select 300 primary
care analyses with PSA determination for each month from January to April 2018. The
investigators will select the patients who satisfy the inclusion criteria consecutively from
this list until 180 are included.
Data collection procedure:
The investigators will collect the following variables from the medical records for each
patient: Demographic characteristics, setting (primary care or clinical service), PSA tests
carried out in the last 12 months and PSA value, anthropometric measures and other
comorbidities.
The investigators will analyze the appropriateness of PSA determinations according to the
criteria established by the clinical practice guidelines of the EAU, and the May 2018 update
of the USPSTF. All the reviewers are trained in the use of these guidelines.
A pilot study of a sample of 30 determinations will be independently evaluated by the nine
researchers the application of the determined criteria. If the agreement is high, the rest of
the determinations will be evaluated separately by at least two researchers using a
predesigned google form. In case of disagreement between two of the evaluators, the case will
review by a third, or discussed in a joint meeting with the rest of the team.
Data analysis plan:
The analysis will be performed using the Stata IC 15 program. The investigators will estimate
the frequency and 95% confidence interval of the adequacy of PSA determinations to
established recommendations. The investigators will evaluate the inter-observer agreement in
the determination of adequacy using the Kappa index. In order to assess the relationship with
potential explanatory variables, and the magnitude of the association, the investigators will
calculate prevalence ratios. If necessary, a log-binomial regression will be performed to get
an adjusted analysis.
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