Adequacy of Prostate-Specific Antigen (PSA) Requests
Adequacy of Prostate-Specific Antigen (PSA) Requests
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.
Inclusion Criteria:

 -  Patients with a PSA determination requested in a routine health examination from
 primary health centers from the Health Department 17 and 19, in the Valencian
 Community (Spain).

 Exclusion Criteria:

 -  Patients who have been previously diagnosed with prostate cancer.

 -  Patients who are being followed for previous high PSA values.