Introduction

The importance of patient participation and engagement in all levels of care to ensure his or her safety and quality of healthcare provision, has been increasingly recognized, especially in the international scenario.¹ Patient-centered care and perception play an important role, often a distinct or complementary perspective to that of the health professional.² Notifications of incidents related to healthcare, made by patients, family members and caregivers, provide useful information necessary for improving patient’s safety and quality of the care. These notifications may include incidents that are not recognized or reported by health professionals on notification systems.³ The analysis of these incidents also showed that their occurrence may be due to the accumulation of failures over a long time period related to the care delivered, from the hospital to the home environment and the community where the patient lives.² In a study conducted in England in 2018, patients identified incidents related to communication (21.7%), care provided by health professionals (13.2%), problems with the care environment (12.2%) and medications (9.9%).⁴ According to another study, conducted with 80 patients in a surgical clinic in Brazil, 17.5% of them identified some types of incidents during their hospitalization, the most frequently occurring during the medication process (78.5%).⁵

The World Health Organization created the Patients for Patient Safety program in order to ensure that the patient voice is heard and promote patient’s perception at all levels of care, aiming at bringing together patients, families and caregivers to improve health care safety.⁶ To join this initiative, several organizations have developed strategies aimed at strengthening patient participation and engagement, and implemented different actions, involving not only patients but also their families.^7.8 Among these strategies for the promotion of patient participation, incident reporting systems were made available, built and adopted in several countries.^9-12

In the Brazilian context, the National Patient Safety Program¹³ implemented a voluntary incident reporting system due to patient safety concerns. The Brazilian Health Regulatory Agency (Anvisa) developed the Health Surveillance Notification System (Notivisa) in order to receive notifications of incidents, adverse events and technical complaints. Recognizing the importance of health professionals and patients in providing care, Notivisa offers two notification modules for different target audiences: (i) professionals working at the Patient Safety Centers and (ii) citizens - patients, family members, caregivers, friends and ‘other’.¹⁴ The so-called 'citizen' module records voluntary notifications of incidents and adverse events reported by patients, family members, caregivers, friends and ‘other’. In recent years, studies based on information from Notivisa have been published; however, there were no analyses performed using the 'citizen' module.^15.16

Given the challenge of ensuring the safety during provision of healthcare, such initiatives to promote the active participation of patients need to be checked; among them the magnitude and characteristics of incidents related to health services based on patients’ and family members’ perspective, recorded in notification systems. The objective of this study was to describe the incidents related to health services reported by Brazilian citizens on Notivisa.

Methods

Results

In Brazil, citizens reported 935 incidents related to health services between 2014 and 2018. Of the 197 notifications whose type of incident was categorized as 'other', 92 were reclassified (Table 1). The most frequently notified incidents and adverse events were related to medication use (50.8%), patient falls (7.5%) and healthcare-associated infections (7.2%) (Table 1). Of the 105 reclassified notifications, 70 described types of incidents that had not been foreseen on the Notivisa system - 'citizen' module. This description made it possible to allocate the incidents in new groups, such as those related to clinical process or procedure, behavior and structure (Table 2). However, 35 notifications were not reclassified or grouped due to inaccuracy or incompleteness of the answers.

The highest frequency of notifications was found in 2018 (44.9%), followed by 2016 (23.3%), 2015 (11.8%), 2017 (11.0%) and 2014 (9.0%). The majority of notifications came from the Southeast (37.5%), followed by the Northeast (24.2%), South (16.5%), Midwest (15.8%) and North (6.0%). With regard to the Federative Unit, the highest frequencies were observed in the states of São Paulo (15.5%), Minas Gerais (15.4%) and Maranhão (10.9%), and the lowest frequency of notifications was found in Paraíba and Roraima.

Individuals responsible for the notification identified themselves as 'other' (49.4%), followed by the 'affected person' (25.6%). Most incidents occurred among female patients (60.9%), ≥66 years (20.1%) and of white race/skin color (51.0%); 15.1% of individuals who reported the incidents did not mention the patient's race/skin color (Table 3). With the exception of these cases with no variable information, patients of white race/skin color represented almost twice as many (60.1%) as those of brown race/skin color (30.9%), and black race/skin color that together accounted for 36.6%.

Most incidents and adverse events occurred during the provision of care, treatment or surgery (37.3%), in daytime (58.3%). Hospital setting was the ‘location of the incident’ with the majority of notifications (37.4%); 32.9% of the incidents were considered mild and 2.4% resulted in deaths (Table 4).

Discussion

Most of the reported incidents were related to the use of medications, followed by patient falls and healthcare-associated infections. These incidents affected most women, the elderly and citizens of white race/skin color, and occurred more frequently during the provision of care, treatment or surgery, in the hospital and in daytime. Regarding the degree of damage, for one-third of the notifications the damage was considered mild, severe damage was the least frequent, and the proportion of deaths was less than 2.5%. The general adherence to the notification system was considered low, five years after its implementation.

The high proportion of incidents categorized as 'other' and the inaccuracy or lack of information in the open fields made the analysis difficult and therefore limited this study. After the reclassification of the incidents originally reported in the category 'other', it could be seen that most of these notifications could have been recorded in specific fields predefined in the system.

There was a low general adherence to the notification system, even five years after its implementation. During the study period (2014 to 2018), 57,281,573 hospitalizations were carried out only in the Brazilian National Health System.¹⁸ Given the incidence of adverse events, which ranges from 7.6% to 10.0%, approximately 4 million adverse events that resulted in damage could have occurred.^19.20 Taking into consideration this number of hospitalizations, 935 notifications of incidents over a five-year period seems to be below expectations. This evidence is related to patients’ and family members’ perception and knowledge of health, they may be unaware of the opportunity to report to notification systems that are not well known locally and also to the fact that individuals do not have an obligation to record these incidents. Among the factors that may affect the involvement of patients and family members in notifications are issues related to the characteristics of the notification system, such as ease of notification, the use of comprehensible terms and well-elaborated questions,⁹ and the knowledge of patients who should perceive some kind of benefit of reporting the incidents.¹⁰ Studies that used patient-centered notification systems as a source of information analyzed a number of notifications lower than that performed here, but with circumscribed time cuts.^9-11 Rethinking the system design in partnership with users, in addition to Notivisa dissemination campaigns, may be strategies capable of increasing their participation in the notification of incidents during the provision health care. Similarly, the development of new methodological approaches aiming at capturing patient report, would facilitate the patient and his or her family engagement in the notification of incidents.²

In addition to the reduced number of notifications, they were geographically circumscribed. The Southeast region concentrated most of them, comparatively, especially the states of São Paulo and Minas Gerais. This finding is important because the Southeast is the most populous region. It is more economically developed and has a larger number of health facilities, compared to other regions in the country, and consequently has a higher volume of consultations and hospitalizations.²¹ On the other hand, it presents the lowest number of incident notifications. The North region presents a geographical, demographic, economic and service scenario diametrically opposed to that of the Southeast. This difference should be taken into consideration when analyzing the results that were found, given that these may reflect the perspective of the users from the Southeast, although the scope of this study was national.

The most frequently reported incidents on Notivisa-'citizen' module were related to medication, falls and healthcare-associated infections with low-severity clinical condition, findings similar to those of two other studies conducted in the United States^9.10 and Finland,¹¹ published between 2017 and 2018, which used notification systems aimed at patients and family members based on medication-related problems,^9.10 falls¹¹ and infections,¹⁰ and did not reported damage.^9.11

Citizens reported perceptible incidents related to healthcare, which poses a serious challenge to patient’s safety and quality of the care around the world. Medication-related problems were the most frequently reported by patients and family members, inside and outside health organizations.^1.22

Falls were found to be the second most frequent type of incident. They can lead to prolonged hospital stay, treatment costs, in addition to generating severe sequelae in the patients.²³ Similarly, healthcare-associated infections were the third most frequently notified event,²⁴ they also represent a major challenge for patient safety in low- and middle-income countries,²⁵ capable of causing harm to all individuals involved, excessive spending for the health system and families, and even deaths.^25-27

Most of the reported incidents occurred among the elderly, finding similar to a medical record-based observational study, conducted in Brazil in 2019,²¹ partially explained by the higher number of comorbidities, longer hospital stay, and use of multiple medications.^28-30 Regarding the degree of damage, mostly mild, the result was similar to that of other studies that used data from notification systems aimed at patients, family members and caregivers.^9.11 However, citizens were also able to report serious incidents that resulted in death. In general, patient reports seem to be more detailed and explicit than those of health professionals, constituting a valuable source of information for the analysis and improvement of health services.³⁰

There was a low number of notifications during the study period. It could be seen a higher frequency of incidents related to the use of medications, followed by patient falls and healthcare-associated infections. These findings show that citizens have the capability to recognize and report such incidents as patient safety issues. In order to better understand the dynamic use of this type of platform by the citizen and, consequently, improve patient and family adherence, further studies on Notivisa should be conducted based on the perspective of patient-centered care.