Population and Registry Area: FVL is a quaternary-level of care private non-profit academic medical center in Cali, the capital of Valle del Cauca, a State located in the Southwestern region of Colombia. FVL serves as a reference center that delivers healthcare services to an estimate of 12,700 patients per year. Referrals mainly come from the Southwestern States of Colombia (Valle del Cauca, Cauca, and Nariño), but also from some other Latin American and Caribbean countries. In 2018, FVL reported a total of 14,421 cases of patients with cancer [11].
Cancer treatment facilities include the following services: pathology, clinical laboratory, diagnostic imaging, hematology, oncology, surgical oncology, chemotherapy, radiotherapy, nuclear medicine, transplants, and palliative care. Furthermore, there is a Department of Data Management (including statistics), Department of Clinical Management (good clinical practices and health care quality), and an Epidemiological Surveillance Committee. FVL is located in the urban area of Cali (District 17, San Joaquín neighborhood). The RIC is an HBCR that started to function on April 13, 2018, and its database includes patients with diagnosed cancer from January 1, 2014.
Registry Organization: The RIC is located at the Centro de Investigaciones Clínicas (CIC) of FVL, which belongs to the institution’s Research and Innovation Sub-directorate. FVL funds this registry. The work team comprises individuals from various functional specialties: a physician, a statistics professional with a master’s degree in statistics, a systems engineer, and a data entry specialist (auxiliary nurse). The process is supervised by specialized physicians: a pathologist and an oncologist.
Cancer registries are considered one of the primary sources of cancer information in Colombia and are part of the public health surveillance system, according to Act 1384, 2010 [12].
The RIC is advised by two cancer registries: Registro Poblacional de Cancer de Cali (RPCC) and Smilow Cancer Hospital-Yale Cancer Center Tumor Registry. The first is a PBCR created in 1962, and it is funded and supported by La Universidad del Valle, a public university. RPCC is affiliated to Department of Pathology – School of Medicine, and has more than 50 years of experience in cancer-related registration data in the city and is a pioneer registry in Latin America [3, 13, 14]. It also had the adviced of Smilow Cancer Hospital-Yale Cancer Center Tumor Registry, the oldest tumor registry in the USA, organized in 1926, that operates under the leadership of the Cancer Committee, in accordance with the American College of Surgeons Commission on Cancer (ACoS CoC), Connecticut Tumor Registry and SEER Coding Manuals. It is located in the Yale Department of Therapeutic Radiology
Implementation process: The implementation approach was done according to four implementation outcomes (acceptability, adoption, feasibility, and cost) [15] (Table 1). We established different strategies focused mainly on stakeholders and decision-makers of our hospital that included chief executive officer (CEO), executive board, cancer committee, tumor board, cancer specialists, and cancer researchers. The strategies included presentations about cancer registries and their impact in the cancer epidemiology and control (Departments of Data Management and Clinical Management and Epidemiological Surveillance Committee), participation in different hospital meetings as tumor board and research meetings. Then, we create a small working group to develop the HBCR with specialized support and consulting of RPCC and Smilow Cancer Hospital-Yale Cancer Center Tumor Registry; this group reviewed the most relevant literature related to cancer registration, methodologies, and statistical analysis. Finally, the group proposed a work plan that included capacity building in cancer registration and methods (participation in International Association of Cancer Registries courses, and conferences), development of cancer registries software tool, data collection process (including extraction of different sources of information and education in cancer and staging coding), results presentations (periodic reports, annual report and participation in scientific and academic events) and sustainability (funding).
Case Definition: Individuals of any age, sex, and origin who were treated in any FVL service and were diagnosed with a malignant tumor, regardless of its anatomical location. The diagnosis basis may be microscopical (fluid cytology, peripheral blood, marrow, histology of primary tumors, and autopsy) or macroscopical (clinical, surgical, and imaging diagnosis). The following types of cancer are included: single or multiple primary malignant tumors, central nervous system tumors, in situ breast and cervical cancers, uncertain behaviors tumors, metastatic tumors, basal and squamous cell skin carcinomas.
The definition of the class of case provided by the International Agency for Research on Cancer (IARC) is accepted for analytic and non-analytic cases [16]. Table 2 shows the different classes of cases in the registry. Analytic cases are those included in the hospital annual report and are used to assess in terms of caring for cancer patients; conversely, non-analytic cases are excluded from most tabulations, especially from survival estimates but may be included in tabulations assessing the cancer burden of the hospital, among others [17].
Data Collection: The RIC collects data through software designed and created by FVL, Sistema de Información del Registro Institucional de Cáncer (SIRIC, by its Spanish acronym). Then, data is stored into four modules: patient identification, cancer identification, the first course of treatment, and outcomes.
Data collection takes place under the recommendations proposed in the 2016 Facility Oncology Registry Data Standards (FORDS) [18]. Furthermore, the registry includes breast, cervical, and childhood cancer data collected for Mandatory Notification Record established by the National System of Public Health Surveillance (SIVIGILA: Sistema Nacional de Vigilancia en Salud Pública, by its Spanish acronym) of the Colombian National Health Institute (INS: Instituto Nacional de Salud, by its Spanish acronym) [19], as well as, information from Resolution 0247, 2014 enacted in 2014, that sets the report of patients with cancer in the High-Cost Diseases Fund (CAC: Cuenta de Alto Costo, by its Spanish name) established by the Ministry of Health [20].
Cancer diagnostic coding is done according to the International Classification of Diseases for Oncology, third edition (ICD-O-3) [21], and the staging is done using the American Joint Committee on Cancer, eighth edition (AJCC 8th) [22].
Case finding is a mixture of an automatic and manual process. The RIC obtains the information passively through the Epidemiological Surveillance Committee (with the mandatory notification forms for tumors of public health interest in Colombia), and the pathology and clinical laboratory reports (who carry out a mark of malignancy: present or absent) in all the samples analyzed.
Active information recruitment is carried out through the Department of Data Management and the Cancer Functional Unit. First, the medical records of all patients treated in the hospital with ICD-10 codes corresponding with malignancy are searched. Then, a manual review of all medical records obtained for malignancy to verify if they are cancer cases is done. In the same way, the data is compared with the information available in the Cancer Functional Unit to capture patients who only come to receive treatment (those who have not been initially diagnosed or followed up within the hospital).
Once cases are identified, a data abstraction process by modules is realized. Patient identification and outcomes modules are obtained automatically by crossing the data between the different databases (hospital discharge, vital statistics, medical records). In contrast, for cancer identification and the first course of treatment modules, data is obtained through manual review from clinical records.
For training in coding, abstracting, and staging, we used The Cancer Registry CASEbook published by April Fritz[23, 24].
Data Sources: Four primary data sources have been identified for the RIC: 1) Department of Data Management; 2) Department of Pathology and Clinical Laboratory; 3) Epidemiological Surveillance Committee; 4) Cancer Functional Unit. All the data is stored in the RIC Data System (SIRIC), which has been designed to manage and store cancer cases for the registry. Figure 1 summarizes the data capture and collection process conducted for the HBCR. Data is presented in a structured digital format.
Follow-up: Once a cancer case is identified within the hospital, to update the modules, SIRIC established a crosslink between the following databases:
Cancer Functional Unit: A hospital´s service that serves as a follow-up cancer patients sentinel. All the patients who are going to receive systemic therapy and bone marrow transplantation are followed through with this service.
Department of Data Management: This area is responsible for managing and saving data about vital statistics, High-Cost Diseases Fund reports and Hospital discharges. In the case of the deceased, it records the date of death, while for the living, it enters the last date of contact with the hospital. Also, this department stores information regarding oncological surgery and radiotherapy procedures. It is the most relevant database in the hospital.
RPCC: a transference process between this PBCR and our HBCR was defined, to update the date of the last contact, because there are patients that die at different health facilities in the city, and RPCC has a long experience in this data collection.
If a patient continues his management in an institution outside of Cali, the information and follow-up capacity is limited since there is no possibility of monitoring the patient once he leaves the city. For this reason, RIC classified the cases as analytical and non-analytical, according to IARC recommendations (see Table 2). Non-analytical cases impact the care burden (volume), but not on institutional management outcomes (quality and performance of care).
To determine the date of death or last contact after finishing the period of treatment in the hospital, we have an agreement with the RPCC. This collaborative inter-institutional alliance allows crossing bidirectionally the information to complete valuable data in both registries.
Quality Control: There is no standard method for quality control of information from HBCR. All the techniques used are an extrapolation from quality control performed in PBCR. The recommended indicators are comparability, timeliness, validity, and completeness [25, 26], being validity and completeness[27] essential for this process.
In our HBCR, a randomized review of at least 10% of the cases is performed in each calendar year. A general practitioner trained in filling out information from the HBCR reviews the information recorded in each case, verifying the consistency of the data and looking for possible errors in both coding and tumor identification. When doubts arise despite this process, a review is carried out together with a pathologist and an oncologist to guarantee data quality.
Statistical Analysis: Statistical analysis is mainly descriptive. Absolute frequencies per year are presented according to the primary site and site group (systems). This information is stratified by analytic and non-analytic cases. Distribution by sex, as well as trends for the leading cancer types defined by the Ten-year Plan for Cancer Control in Colombia 2012–2020 [28], are also shown.
Kaplan–Meier’s non-parametric method is used for survival analysis. Survival is estimated using the patient’s diagnosis date and death date (event) or last follow-up (censorship). For the five-year survival analysis, the period analysis is carried out, described by Brenner and Gefeller[29] because there is no complete information for five years of follow-up.
HBCRs cannot be used to obtain incidence measurements of cancer because the population of which such cases are part of cannot be identified[30]. Therefore, the ICR does not generate incidence data.
Ethical Considerations: FVL´s HBCR complies with the Standards and Guidelines for Cancer Registration in Europe (IARC Technical Publication No. 40) [31].
The registry was reviewed and approved by the Institutional Review Board (Protocol number 1337), followed the ethical principles for medical research outlined by the Declaration of Helsinki [32] and took into account the regulations of Resolution 8430/1993 of the Ministry of Health of Colombia [33]. The board considered the registry as a national and local public health interest. It declared as not necessary the informed consent because we will not make any contact with the patients (all data was obtained retrospectively from four data sources), being our primary purpose to evaluate the burden of cancer and quality of healthcare services and administrative support.
To protect the identity and guarantee the security of sensitive information, the SIRIC houses the data in a double-layer architecture. The data layer is on the internal FVL server, which, in turn, is protected by a firewall that guarantees the hospital’s information protection. Additionally, the data is encrypted and masked through a numerical system under the SHA-512 feature set, and to view it is necessary to be within the clinic's LAN or have authorization assigned through a VPN.
Preliminary results of the registry
The RIC database includes patients with diagnosed cancer since January 1, 2014. In 2014–2018, a total of 29,370 cancer cases were treated in FVL, 8.3% (n = 2,439) were reported as dead within the institution, 58.87% (n = 17,290) were women, and 50.83% (n = 14,928) belonged to analytic cases according to the IARC definition.
From its foundation on October 20, 1982, to December 31, 2018, FVL has provided the RPCC a total of 21,641 cases evidencing that 73.68% of tumors diagnosed and treated in FVL belong to patients living in Cali.
Table 3 presents cancer distribution cases in FVL between 2014–2018 for both sexes. The most common types of tumors include breast (n = 4,315), hematolymphoid (n = 3,481), thyroid (n = 3,056), prostate (n = 2,733) and colorectal (n=1,265). Figure 2 shows the frequency distribution for the main anatomical locations according RIC estimation. Breast cancer was the most frequent in women (n=4,275), and the prostate was the most frequent in men (n=2,733). Figure 3 presents the top ten cancer sites by sex.
The RIC database includes all cancer cases diagnosed as of January 1, 2014; when crosslinked this information with the RPCC, an increasing and consistent trend was observed for new cases that occurred in 2014–2018. Table 4 presented case distribution cases per year, period 2014-2018. It showed new and prevalent cases at the same period. All cases from 2014 were defined as new.
The top three States with the highest number of cases treated in the FVL were Valle del Cauca (n=12,741), Cauca (n=948) and Nariño (n=188). Figure 4 shows the residence of cancer cases attended at FVL in 2018, located in Colombia map by States.
The survival estimates by period method for the 2014 cases were: breast 87.97% (95% CI 83.70-93.92), prostate 86.28% (95% CI 76.97-92.01), colorectal 82.90% (95% CI 73- 82-89.07), cervix 81.81% (95% CI 66.75-90.51) and stomach 55.89% (95% CI 42.65-67.24).