Safe surgery checklist: evaluation in a neotropical region

ABSTRACT Objective: assess patient responses and associated factors of items on a safe surgery checklist, and identify use before and after protocol implementation from the records. Methods: a cohort study conducted from 2014 to 2016 with 397 individuals in stage I and 257 in stage II, 12 months after implementation, totaling 654 patients. Data were obtained in structured interviews. In parallel, 450 checklist assessments were performed in medical records from public health institutions in the Southwest II Health Region of Goiás state, Brazil. Results: six items from the checklist were evaluated and all of these exhibited differences (p < 0.000). Of the medical records analyzed, 69.9% contained the checklist in stage I and 96.5% in stage II, with better data completeness. In stage II, after training, the checklist was associated with surgery (OR; 1.38; IC95%: 1.25-1.51; p < 0.000), medium-sized hospital (OR; 1.11; CI95%; 1.0-1.17; p < 0.001), male gender (OR; 1.07; CI95%; 1.0-1.14; p < 0.010), type of surgery (OR; 1.7; CI95%: 1.07-1.14; p < 0.014) and antibiotic prophylaxis 30 to 60 min after incision (OR; 1.10; CI95%: 1.04-1.17; p < 0.000) and 30 to 60 min after surgery (OR; 1.23; CI95%: 1.04-1.45; p = 0.015). Conclusions: the implementation strategy of the safe surgery checklist in small and medium-sized healthcare institutions was relevant and associated with better responses based on patient, data availability and completeness of the data.

Therefore, the goal of this study is to assess the responses of patients in each phase of the safe surgery checklist implementation process and its associated factors. We also verified the checklist use before and after the implementation of the protocol, through its presence in patients' records.

METHOD Study Scenario and Design
We conducted a cohort study, with assessment before and after the performed intervention, at the Southwest II Health Region, state of Goias, Brazil, with patients admitted for surgery in the operating rooms of public hospitals of small and medium size. We also carried out a retrospective analysis from the medical charts containing records of the checklist from elective and emergency procedures. The sample, both of patients and medical records, was non-probabilistic, selected consecutively throughout the collection period.
The realization of this study, part of the main project "Safe Surgeries Protocol in a Neotropical Region in Central Brazil", presents results in two stages: before the implementation of the protocol of safe surgeries and after the protocol establishment process, based on WHO's recommendations [3][4] . In Phase I, it comprised five municipalities 13 (Aporé, Chapadão do Céu, Caiapônia, Mineiros, and Jataí), and in Phase II, four, as the Mineiros county was not initially assessed due to temporary renovations.   We excluded records with incomplete information. At the same time, we selected medical records of patients who underwent surgery for analysis as to the existence and completion of the checklist after its release.

Inferential Analysis
In this study, we analyzed two sections

Sociodemographic Data and checklist items
We interviewed 654 patients after their surgical procedures, 397 before implantation, in Phase I, and 257 in Phase II. Table 1 shows the sociodemographic data, before and after the training of professionals, respectively. Of the 654 respondents, more than half were female (56.4%), aged 20 to 40 years (66%), with education up to 12 years of study (85%) and income between 2 and 5 minimum wages (61.5%). Among these, most underwent elective surgery (61.8%) and spinal anesthesia (73.7%). Most hospitals were small-sized (53%) and the participants lived in the same municipality (56%). There were statistically significant differences in patient's responses between Phases I and II for sex (p = 0.001), education (p = 0.000), income (p = 0.000), type of surgery (p = 0.036), and municipality of origin (p = 0.000), (Table 1).

Presence of the checklist in the medical records and data completeness
Regarding the existence of the safe surgery checklist according to hospital size, Table 3     Good practices that add value to the care quality in safety culture are important and, in this perspective, communication is part of them. We observed that the patients signed the consent form before the operation but did not remember having done so when approached soon after the procedure. We emphasize that this action should be performed even without the availability of the checklist, as recommended by the Ministry of Health, as a mandatory condition for the operation. After training, Phase II data showed a relative improvement, confirmed by 72.4% of participants stating they had been informed.

DISCUSSION
A study conducted in a large hospital found that the signed informed consent form was present in 93.4% of records, however, the focus of that research is not presented from the patient's perspective. The "patient identification, surgery, and surgical site" was the least checked item (85.8%) 16 .
In Phase I of our study, only one medium-sized hospital made the checklist available on the chart. Even however, in studies carried out in Brazil, it appears we have different realities 1,7,9,14 .
The adoption of the recommendations of Safe Surgery Saves Lives Program shows growing concern of the institution and its professionals in the pursue of patients' safety in the surgical context. In this sense, a study carried out in a large hospital in Brazil identified that the responsibility for conducting the safety check was of the room circulating nurse, with the participation of the anesthesiologist and the surgeon, since some items on the checklist are the responsibility of specific professionals 16 .
Another study, conducted in Florianopolis with nurses in operating rooms, evaluated compliance with the ninth goal, which is to communicate effectively and to exchange information critical to the safe performance of the operation. There was an 84.5% participants' compliance 23 . In a research conducted in Switzerland with surgeons and anesthesiologists to assess their opinion on the checklist, most agreed that this tool contributes to procedures' safety and team communication; however, there is still resistance, both by some professionals 24 and to its use 16 .
We emphasize that only the checklist is not able to promote a safety culture in surgical care, given the complexity and the multiple facets of a surgical event 16 . to bring many benefits. These are associated with a reduction in mortality, dissemination of a patient safety culture, and a reduction in surgical site infections 10,19,26 .
We highlight that, in the current research, in addition to the proportional increase in the use of the instrument, the completion of the fillings increased from 39.5% to 60.5%.
In this regard, we infer that there was a positive response of the implementation of the safe surgery checklist in the public hospitals of the studied municipalities.
A study performed in public, teaching hospitals in Brazil pointed out that there was a considerable decrease in the number of unfilled checklists, though with increasing number of incomplete instruments 1 . A research from Southern Brazil found no significant adhesion on the use of the instrument and the verification of the checklist items was not verbal 14 . The incomplete filling of the instrument is a phenomenon that can occur in other scenarios 1,15,17,20 . Different studies reported that the challenge of the checklist implementation continues, both in Brazil and worldwide, and suggestions aimed at better enforcement of the process involve professionals from all specialties 28 . As for the filling, it requires engagement of the operating room staff for greater adhesion 16 .
It is noteworthy that the experience with the use of the checklist is reported in many countries, and even then, adverse events related to surgical procedures may occur. The use of the checklist can contribute to the reduction of harm and fatal outcomes, despite the challenges arising from the frequent lack of data filling 16-21 . This study contributes to the awareness about