The World Health Organization’s safe surgery checklist is a useful tool to reduce adverse events in hospitals, but its effective implementation is still a challenge. This study aims to assess adherence to the checklist in urological and gynecological surgeries in two teaching hospitals in Natal, Rio Grande do Norte, Brazil. The design was observational transversal; elective surgeries were selected, and the collection took place through a review of medical records. Adherence was described based on the existence and quality of filling out the checklist, and the association of structural and socio-professional factors was analyzed using multiple regression analysis. Of the 375 surgeries reviewed, 61% had a checklist, and 4% were fully completed. The existence of the checklist was associated with gynecological surgeries (maternity) (OR = 130.18) and longer duration of surgery (OR = 2.13), while the quality of filling was associated with urological surgeries (general hospital) (β = 26.36). Adherence to the checklist needs to be improved, and the differences suggest the influence of the different implementation strategies used in each institution.
Checklist; Patient Safety; Operative Surgical Procedures.
The safe General Surgery Instruments checklist is a useful tool to reduce adverse events in hospitals, but its effective implantation is only straight. This study aims to evaluate adherence to the checklist in urological and gynecological surgeries of university hospitals in Natal, Rio Grande do Norte, Brazil. The design was observational transversal, selected for elective surgeries, and the collection of data was based on a review of clinical histories. If it describes the compliance from the existence and quality of the compliance checklist and the association of structural and socio-professional factors is analyzed through multiple regression analysis. Of the 375 surgeries reviewed, 61% had a checklist, and 4% were fully complied with. The existence of the checklist was associated with gynecological surgeries (maternity) (OR = 130.18) and the longer duration of the surgery (OR = 2.13), while the quality of compliance was related to urological surgeries (hospital general) (β = 26.36). Adherence to the checklist is an opportunity to improve, and the differences suggest the influence of different execution strategies used in each institution.
Checklist; Patient Safety; Operative Surgical Procedures
Complications related to surgical procedures are frequent and represent a health problem today. Weiser et al.1estimated those 234 million surgical procedures were performed worldwide in 2004, one for every 25 people alive, resulting in two million deaths from these procedures and seven million complications, 50% of which were preventable. In hospitals, one patient dies for every three hundred admitted, and the cause of death for more than 50% of these is related to preventable surgical errors two.
In a study carried out in 58 hospitals in South American countries (Argentina, Colombia, Peru), Costa Rica, and Mexico, Arana-Andrés et al. 3estimated that the prevalence of adverse events related to patient safety is 10.5%, more than 28% of them resulting in disability and 6% in death. In that study, almost 60% of events were considered preventable. In Brazil, Mendes et al.4point out that 66.7% of adverse events identified in three teaching hospitals in Rio de Janeiro were preventable, a proportion slightly higher than that found in other countries and in Latin America, 35.2% of these occurring in surgical procedures. In 2012, these researchers identified, in the same hospitals that 65.8% of patients had adverse events, and a proportion of 68.3% had preventable surgical adverse events. About one in five patients with adverse surgical events progressed to permanent disability or death5.
Previous epidemiological data confirm the dimension of patient safety problems, particularly surgical ones, in hospitals in our context. Given the high frequency and severity of the associated damage, insecurity in surgery emerges as a public health problem, despite little recognition of its extent.
In 2004, the World Health Organization (WHO) launched the World Alliance for Patient Safety to facilitate the development of a policy to improve patient safety and the quality of health services in the Member States. The actions are organized in the form of safety campaigns called global challenges for patient safety, initially presenting three challenges: clean care is safer care, safe surgery saves lives, and prevention of antimicrobial resistance 6. In 2008, the chosen area was the safety of surgical care, for which the Manual “Safe Surgery Saves Lives” was developed, adopted by the National Health Surveillance Agency (ANVISA), and widely disseminated in Brazil 6, 7.
A Surgical Safety Checklist (checklist) was proposed to be used in any hospital, regardless of its degree of complexity, whose objective is to help surgical teams systematically follow critical safety steps8. The use of this tool aims to improve surgical care in the world through safety standards that can be applied in all countries 7, 9. The checklist consists of 19 items divided into three moments: before anesthetic induction, before the surgical incision, and before the patient leaves the operating room.
Scientific studies have already proven that the institution of the checklist in surgical procedures reduces the rates of mortality and complications, increases adherence to antibiotic prophylaxis, and reduces the number of errors due to lack of communication by the team10. According to Haynes et al.11, in a study that evaluated the effectiveness of the checklist in elective surgeries performed in eight countries, major complications were reduced from 11% to 7% (p < 0.001), mortality fell from 1.5% to 0.8% (p = 0.003), and adherence to antibiotic prophylaxis increased from 55% to 83%. Weiser et al.12, evaluating emergency surgeries, reported a reduction from 18.4% to 11.7% in complication rates and from 3.7% to 1.4% in mortality rates.
Studies carried out in developed nations, such as Spain (nine public hospitals), England (one institution), and France (18 hospital centers), evaluated adherence to the checklist, obtaining 83.3%, 96.9%, and 90.2% as results. , respectively 10, 13, 14. The Spanish study related the adherence to the checklist to the variables hospital size, type of anesthesia, surgery shift, gender, and age of the patient, finding a higher percentage of items filled out in surgeries performed in small and medium-sized hospitals; in surgeries with local anesthesia, the percentage found was lower. Regarding developing countries, Spatial et al.15report a positive experience in Thailand, where 4,340 WHO checklists were applied. The authors conclude that its implementation can be effective in countries with limited resources.
In Brazil, studies on adherence to the WHO safe surgery checklist were not identified. Likewise, there are no reports of implementation experiences or results of adherence to this new technology in the subgroup of university hospitals, which, due to their characteristics of learning environments, can be strategic for the dissemination of the routine use of this preventive measure in health services. Health. Understanding the checklist implementation and adherence process, as well as the items not complied with by the surgical teams, can inform about the barriers to its effective use and provide subsidies for the necessary adjustments in order to adapt its use and ensure patient safety.
This study aimed to evaluate adherence to the safe surgery checklist in urological and gynecological surgeries in two teaching hospitals in the Rio Grande do Norte, Brazil, as well as to identify the association of organizational, demographic, and surgical factors with its use.
This is an observational and cross-sectional study, carried out from January to March 2012, in two teaching hospitals of the Federal University of Rio Grande do Norte (UFRN), located in Natal, Rio Grande do Norte, Brazil. One of the hospitals is characterized as a general hospital with three hundred beds, is a reference of medium and high complexity for the state, covering 29 specialties. The second hospital is a teaching maternity hospital, focused on women’s health care, being a reference for high gestational risk and gynecological surgeries, with 110 beds, including those for the maternal and neonatal intensive care unit.
In September 2011, the checklist was implemented in the surgical center of the general hospital through an articulation between its management, the Hospital Infection Control Commission, and the surgical specialty of urology. Meetings were held not only to present and adapt the instrument to be used, highlight its importance and impact on patient safety but also to organize the logistics of applying the tool, with the participation of nurses, surgeons, and resident physicians. The checklist is available in the patient’s electronic medical record, printed upon arrival at the operating room, and filled in by the resident physician. It is an adaptation of the model recommended by the WHO, being added “blood typing and reserve of confirmed blood products” as a sub-item of the item “risk of blood loss.”
In the maternity ward, the checklist was implemented in May 2011 by an initiative of the clinical management, which established it as a mandatory routine for elective gynecological surgeries. Therefore, awareness actions were carried out with the surgical center teams through educational meetings, seeking to prepare them for its use. The checklist used in this hospital is attached to the patient’s medical record and filled out by the nursing staff. It is an adaptation of the model established by the WHO, with the following changes: addition of the item “expected duration of surgery,” exclusion of the item “demarcated surgical site,” and lack of space for marking the item “completed anesthetic safety verification.” These adjustments were made by the institution’s team without the participation of researchers.
Considering that the implementation of the checklist did not occur in all surgical specialties attended at the two hospitals, the target population of the study was limited to elective urology surgeries of the general hospital, as the incorporation of the instrument was an initiative of the specialty itself, and gynecological surgeries in the maternity hospital. The selected sample included all surgeries of these specialties performed from January to March 2012 (n = 385), identified in the information system of each hospital. Interventions whose medical records were not found were disregarded, which was the study exclusion criterion.
The dependent variables, or indicators of adherence to the checklist, were as follows: the existence of a checklist in the medical record; complete completion of the instrument (marking of all 19 items specified below); complete completion of each moment: before anesthetic induction (time 1 – items 1 to 7), before the surgical incision (time 2 – items 8 to 14) and before leaving the operating room (time 3 – items 15 to 19); filling in each of the items; percentage of items filled by checklist.
Moment 1. Before anesthetic induction: (1) patient data identification and consent; (2) demarcated surgical site; (3) anesthetic safety check; (4) pulse oximeter; (5) allergies; (6) difficult airway; (7) risk of blood loss.
Moment 2. Before the surgical incision: (8) presentation of team members; (9) confirmation of patient data by the team; (10) critical events: surgeon; (11) critical events: anesthesia; (12) critical events: nursing; (13) antibiotic prophylaxis; (14) imaging exams.
Moment 3. Before leaving the operating room: (15) procedure record; (16) instrumental counting; (17) sample identification; (18) problems with equipment; (19) Recovery review.
The independent variables evaluated, potentially associated with adherence, were as follows: care center (general hospital and maternity hospital); month (January, February, and March); shift (morning, afternoon, and night); surgeon sex (male and female); type of anesthesia (local, regional, general); duration of surgery (≤ 30min, 31-120min, > 120min). The care center variable considers that the professional who applies the checklist, the surgical specialty, and the implantation method make up its characterization, which is why they are considered covariates.
The checklists filled were accessed in a file stored in the operating room of the general hospital; in maternity hospitals, the source was their medical records. Data were collected at the same time by four previously trained medical students, and disagreements were resolved by consensus at the time of assessment.
When analyzing the data, in the case of the maternity checklist, items 2 and 3, despite not being available in the document for checking, were considered as not completed in the analyses, since this study assesses adherence to the drawn list, validated and evaluated by WHO. Items added in the adaptation of the checklist of each hospital were not considered as variables in the analyses.
To quantify the level of adherence, a description of the point estimate of compliance with adherence indicators (dependent variables) and their corresponding 95% confidence intervals (95%CI) was performed: (1) existence of a checklist in the patient’s medical record; (2) complete completion of the checklist; (3) complete completion of each moment; (4) completing each item on the checklist; (5) percentage of items completed by checklist (completion quality). All these data were presented in general, stratified by care center, and approximated to whole numbers.
Then, bivariate analysis of the possible association of independent variables (care center, month, shift, gender of the surgeon, type of anesthesia, and duration of surgery) with two indicators of adherence was performed: the existence of a checklist in the medical record and percentage of completed items by checklist. The statistical significance of the difference between the percentages of compliance as a function of the categories of each independent variable was calculated using the chi-square tests for the existence of a checklist, and Kruskal Wallis and Mann Whitney, for the percentage of filled items. In the specific case of the variable duration of surgery, the correlation of its result in minutes (not categorized) with the percentage of items filled out by the checklist was also tested using the Pearson correlation test after proving the normal distribution of these data.
The joint influence of the variables was tested using multivariate analysis models, using Multiple Linear Regression, for the variable percentage of items filled by checklist, and Logistic Regression, for the variable existence of checklist. In both cases, the enter and stepwise methods were used to find the most efficient models in terms of explaining the variability found (measured by the R Squared).
In all cases, the significance level α adopted was 5%. Data analyzes were performed using SPSS, version 16.0 (SPSS Inc., Chicago, United States).
This study was approved by the Research Ethics Committee of UFRN, opinion number 492/2011.
There were 385 surgeries performed in the period, 164 in urology (general hospital), and 221 in gynecology (maternity). Nine in the maternity ward and one in the general hospital were excluded, as no medical records were found, and 375 surgeries were evaluated: 212 gynecological (56.5%) and 163 urological (43.5%). Most surgeries took place in the morning, lasting between 31 and 120 minutes, using regional anesthesia and performed by male surgeons.