The evaluation of quality indicators of the care program for patients with breast cancer was carried out through a retrospective longitudinal descriptive observational study.

The main source of information was the medical records of the REDSALUD computer application which was used in the San Juan de Dios Hospital in Cali, in its Consultorio Rosado program, for the period 2017 and 2018. This information was consolidated through the Office of Statistics and Records.

The research was carried out at the San Juan de Dios Hospital Foundation which provides health services of medium and high complexity, which mainly serves the vulnerable population, and which is included in the public network of Cali. The hospital has the following services: emergency, external consultation, intensive care units for adults, and intermediate care for adults and pediatrics. It offers hospitalization services with 175 beds and has a surgery with 8 operating rooms. It has around 122,226 patient admissions annually.

The “Consultorio Rosado” comprehensive care and follow-up program was created in 2013, attached to the San Juan de Dios Hospital Foundation. This program's mission is to provide access, in an expeditious manner and without administrative procedures, to the entire consulting population regardless of socioeconomic status, social security regime and Benefit Plan Management Company (EAPB).

The HSJD-CR offers evaluation to potential cases of cancer of any type, through consultation with an expert doctor, diagnostic aids and insurance management in poor uninsured patients. Those who have a confirmed oncological disease are offered a prioritized consultation with a specialist and comprehensive management is arranged with the insurer in the institution, via the hospitalization services, surgery and diagnostic follow-up and therapeutic aids, including palliative management.

Records of adult women diagnosed with breast cancer who were enrolled in the HSJD-CR program during 2017 and 2018, were included. Records of patients with concomitant cancers, breast cancer recurrences, incomplete information, and patients with only one breast cancer were excluded.

Once the information was collected, a quality control was carried out through a sampling of 15% of the data, which was contrasted against the source documents. No inconsistencies were found in the data.

The quality of care was evaluated according to the mission and objectives of the HSJD-CR program and against the indicators proposed by the High-Cost Account ⁵. The tables were built using the fulfillment of the goals proposed by the High-Cost Account for each indicator and with the measurements determined for Colombia during the years 2016 and 2017 as a traffic light.

Eight general indicators were determined: three indicators of opportunity and one indicator of lethality. All the indicators had three levels of numerical qualification and a traffic light system was used for coding: green representing good compliance, yellow representing regular compliance and red representing poor compliance. The average indicators determined in the literature for Colombia in the years 2016 and 2017 were used as a comparison.

This research was approved as a risk-free piece of research by the Ethics Committees of the San Juan de Dios Hospital in Cali, according to Act CEIHSJ010-019 of 2019, and the Universidad Libre Cali, according to act of August 29, 2019. The authors state that they have no conflicts of interest.

It was found that 109 cases (33.1%) had a TNM report. Of these 94 cases (28.6%) were completed correctly. Table 2 shows the staging of patients with breast cancer according to the TNM system.

Tabla 2

Stage	Frequency	%	Distribution
0	19	6	in situ: 19 (20.2%)
IIA	26	8	early 26 (35.1%)
IIB	17	5
IIIA	20	6	infiltrating 74(78.7%)
IIIB	6	2	advanced 48 (64.9%)
IIIC	1	0
IV	4	1
No Data	236	72	236 (72%)
Overall total	329	100

In all the cases included in this study, the pathology report of the breast biopsy was obtained prior to the first treatment and 184 cases (55.9%) underwent surgery. Of these women, conservative surgery was performed in 141 cases (42.1%), mastectomy in 43 cases (13.1%), and 145 cases (44.1%) did not have surgery as the first treatment at the institution. In 10 of the 19 patients who had in situ staging according to TNM, conservative surgery was performed; of the 74 women with infiltrative stages, conservative surgery was performed in 27 (36.5%) (Table 2).

It was found that of the 93 women with a TNM report, in 17 cases (5.2%), there was a medical order for palliative care. Of the 44 patients classified in advanced stage, 4 (9.1%) had a palliative care order. With this information, compliance with the indicators was determined (Table 3). Three indicators were in the green level, two in yellow and two in red.

Table 3

Name	Numerator	Denominator	Cut-off point 2016-2017	Colombia		HSJD-CR
				2016	2017	%(n)	CI (%)
Proportion of women with breast cancer who underwent TNM staging	Number of women with breast cancer who underwent clinical staging (TNM)	Total number of women diagnosed with breast cancer	≥78.7%		91.7	28.3 (93/329)	26-31
			71.5%-78.6%	71.9
			<71.5%
Proportion of women with breast cancer detected as carcinomas in situ at diagnosis	Number of women detected as having carcinoma in situ at the time of diagnosis	Total number of women diagnosed with breast cancer with TNM	≥12%			20.4% (19/93)	18-27
			6%-11%	6.30%
			<6%		5.70%
Proportion of women with breast cancer detected as early invasive carcinoma at diagnosis	Number of women detected as having early stage invasive carcinoma at diagnosis	Total number of women diagnosed with invasive breast cancer	≥50%		51.40%	35.1% (26/74)	30-42
			42%-49%%	42%
			<42%
Proportion of women with breast cancer detected as advanced-stage carcinoma at diagnosis	Number of women detected as advanced-stage invasive carcinoma at diagnosis	Total number of women diagnosed with invasive breast cancer	<50%		48.60%	51.6 (48/93)	55%-72%
			50%-57%
			≥58%	58.0%
Proportion of women with histopathological diagnosis	Number of women with histopathological diagnosis	Total number of women who underwent surgery	≥57%		82.3	100% (184/184)	100%
			36.8%-57.7%	40.7
			<38.6%
Proportion of women with breast cancer who underwent in situ breast-conserving surgery	Number of women with breast cancer in situ who underwent breast-conserving surgery	Total number of women with breast cancer in situ who received surgical treatment	≥90%			90.9% (10/11)	85%-97%
			70%-89%	78.3	77.4
			<70%
Proportion of women with breast cancer who underwent invasive breast-conserving surgery	Number of women with invasive breast cancer who underwent breast-conserving surgery	Total number of women with invasive breast cancer who received surgical treatment	≥65.4%		71.3	36.5% (27/74)	60%-76%
			18.9%-65.3%	54.7
			<18.9%
Proportion of women with breast cancer assessed for palliative care	Number of women with early-stage invasive breast cancer evaluated with palliative care	Total number of women with early-stage invasive breast cancer evaluated for palliative care	To be defined	7.0%	7.4%	0% (0/26)	0%
	Number of women with invasive breast cancer in advanced stages evaluated with palliative care	Total number of women with advanced-stage invasive breast cancer evaluated for palliative care	To be defined	9.3%	7.30%	9.1% (4/44)	1%-18%
	Good	Average	Bad

* Cut-off point 2016-2017: Value of the indicator standardized by the consensus of the CAC for breast cancer and its traffic lights ⁵.

Three indicators of opportunity were calculated, which were evaluated through the averages as indicated by the High-Cost Account. When evaluating the distribution of the data, however, the best comparator was found to be the median and so these results are added in Table 4.

Table 4

Name	Numerator	Denominator	Cut-off point 2016-2017*	Colombia		HSJD-CR §
				2016 †	2017 ‡	Average	Median	Signal
Timeliness of comprehensive care (time between the consultation for the presence of symptoms associated with cancer until the first treatment (days)	Sum of the days elapsed between the first consultation at the institution that made the diagnosis and the first surgical treatment	Total women diagnosed with breast cancer	≤60		91.7			4.6 (6/130)
			61-75					4.6 (6/130)
			>75	234	87.8	170	130	90.8 (118/130)
Timeliness of cancer care- diagnosis (time between the first consultation and diagnosis- reading of the pathology). (Days)	Sum of the days elapsed between the first consultation and the diagnosis (pathology reading)	Total women diagnosed with breast cancer	≤30					23.2 (61/263)
			31-45					23.6 (62/263)
			>45	171	58	57	48	52.3 (140/263)
Timeliness of cancer care- treatment (time between diagnosis- reading of the pathology- up to the first surgical treatment). (Days)	Sum of the days elapsed between the reading of the pathology and the first surgical treatment	Total women diagnosed with breast cancer	≤30		29.8			2.8 (4/144)
			31-45					5.6 (8/144)
			>45	63.5		119	144	91.7 (132/144)
Good	Average	Bad

* Cut-off point 2016-2017: Value of the indicator standardized by the consensus of the CAC for breast cancer and its traffic lights ⁵.

The global opportunity was considered from the first consultation in the institution until the performance of the first surgical treatment, with an average of 170 ± 93 days (Median: 147 and IQR: 114 -211); in 90.8% of the patients, they were attended with an opportunity greater than or equal to 75 days, which corresponds to the red stripe in the traffic lights of the High-Cost Account.

Timeliness in diagnosis was defined from the first consultation to the pathology report, presenting an average of 57 ± 34 days (Median: 48 and IQR: 33-70); 52.3% of the results of the pathology were received after 40 days, which corresponds to the red stripe in the traffic lights of the High-Cost Account (Table 4).

For “opportunity in treatment”, this measurement was considered as the average number of days between the issuance of the pathology report and the first surgical treatment, which was 57 ± 34 days (Median: 102 and IQR: 74-147); 91.7% received the first surgical treatment after 45 days, placing them in the red zone of the traffic lights of the High-Cost Account (Table 4).

When determining the global lethality in the 329 women with breast cancer treated in the HSJD-CR program, it was found, through statistical records held at the Secretary of Health of Santiago de Cali, that 31 patients had died during the study period, which corresponds to at an overall lethality of 9.5%.

Regarding the outcome indicators, it was found that none of the women with early infiltrative stage died (26 women; 0%) and of the 48 women classified as advanced infiltrative stages, 6 patients died (12.5%) (Table 5).

Table 5

Name	Numerator	Denominator	Cut-off point 2016-2017*	Colombia		HSJD-CR +
				2016 †	2017 ‡	%(n)	CI (%)
Lethality in women with breast cancer	Number of women with breast cancer who died during the period - early stages	Total number of women diagnosed with breast cancer in the period -early stages	<1.3%			0 (0/26)	0%
			1.3%-2.0%	1.3%
			>2%		2.5%
	Number of women with breast cancer who died during the period - advanced stages	Total women diagnosed with breast cancer in the period -advanced stages	<4.4%	3.5%		12.5 (6/48)	3%-22%
			4.4%-5.0%
			>5%		6.6%
Good	Average	Bad

* Cut-off point 2016-2017: Value of the indicator standardized by the consensus of the CAC for breast cancer and its traffic lights ⁵.

Of the 51 women who had been authorized to have their first surgical treatment performed in the institution, one death was reported during the study period, which corresponds to 2.0% of the lethality of the HSJD-CR program.

When considering the general indicators of the quality of care in patients diagnosed with breast cancer, treated at the HSJD-CR, this process begins with clinical staging according to the TNM system. This allows a classification of the extent of the disease which in turn guides surgical management and facilitates decision-making regarding treatment. It is considered an important indicator of the prognosis and survival of women. For its determination, different diagnostic tests must be performed: this is, therefore, an aspect that reflects the quality and comprehensiveness of health care ⁵.

In another group of indicators, there are those related to the times of opportunity, diagnosis and treatment. RIAS (Comprehensive Health Care Routes), for example, sets as standard a value less than or equal to 30 days for diagnosis and for the start of treatment for breast cancer. The overall maximum period of care (for diagnosis and treatment) for these patients should be a maximum of 60 days ¹.

According to a study carried out by the National Institute of Cancerology (INC), Colombia, in 2006 and 2007, in 1,106 women receiving treatment for breast cancer in Bogotá, the median time from the first consultation to diagnosis (reading of pathology) was 91 days (95% CI: 82-97 days; Range: 0.2-2,138) and the time from the first consultation (median) to treatment was 137 days (95% CI: 127-147 days; range: 6 to 2,147) ¹¹. We can obtain the time from the reading of the pathology study to the first treatment from the difference between the two times.

In 2017 for the High-Cost Account, a lethality was estimated for the early stage of 2.5% and in advanced stages of 6.6%. We estimate a lethality of 9.4% (CI 11%-17%) for all the patients in this study. It is considered that the indicators are not comparable since they are calculated using different subpopulations.

Regarding the limitations of this study, differences were found in the management in the stages of diagnosis and treatment of patients, the introduction of new technologies and treatment procedures and the variability of cases, given the complexity of the pathology. Additionally, there were deficiencies in the quality of the data, obtained from the clinical history as a source of information. The percentage of missing data for certain variables is the main limiting factor of the results of this study, since this could lead to biased results. The findings do not, however, contradict those presented in the various other studies discussed, so it can be stated that the loss of data did not affect the validity of the results.

The future objective is to improve the quality of the records which will help to determine improvements that could be made to the execution of processes of the different actors within the system and their effects on the subject. The fragmentation of care causes the information to lose uniformity, due to the differences in the processes at each institution that intervenes in patient care. Lastly, the results obtained by the High-Cost Account can only approximate to, and be a reflection of, the reality of the care process, leading to weaknesses as observed in the report. Additionally, the registration of data from the High-Cost Account has only been functional for a few years of operation and for this reason it should be considered a source of data in formation.

The strengths of the present study include the inclusion of all the patients who met the inclusion criteria. This study was carried out by a multidisciplinary team (Physicians, Statisticians, Epidemiologists, Health Administrators) and additionally, there were standard comparators for Colombia.

Due to the above, the external validity should only be obtained for populations and sociodemographic environments similar to that of the present study.