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Risk Factors of Preventable Adverse Events in Obstetrics: History
Please note this is an old version of this entry, which may differ significantly from the current revision.

(Preventable) Adverse Events (pAEs) are an inherent part of all medical care. Obstetrics is characterized by a very high expectation regarding safety and has rare cases of harm, but extremely high individual consequences in case of pAEs. However, no "state of the art" definition of preventability exists. Relevant obstetric risk factors related to error categories need to be identified and categorized to target pAEs. If risk factors can be modified in the future, pAEs in obstetrics and consequent patient harm could be reduced. 

  • patient safety
  • preventable adverse events (pAEs)
  • adverse events (AEs)
  • obstetrics
  • risk management

1. Preventable adverse events (pAEs)

The report “To Err is Human” published in the year 2000 led to a patient safety agenda with a focus on reducing medical errors and promoting safe health systems [1]. Patient safety is defined as “the absence of preventable harm during health care and the reduction of the risk of unnecessary harm” [2]. Adverse events (AEs) are outcomes of treatments below the current expected medical standard that result in temporary or permanent harm to patients [3]. The burden of harm in obstetrics affects not only the expectant mother, but also the newborn and the future family. In addition, the obstetric team is affected and must deal with possible medicolegal consequences of an adverse event. It has been established that about half of these AEs are preventable under healthcare standards. Reducing preventable adverse events (pAEs) is the responsibility of all levels of the healthcare system, with effective cooperation and safe communication within the team and with patients being of paramount importance [4]. The reliability of healthcare lies in the ability of staff to adapt flexibly to the changing challenges of working conditions and patients’ needs [5]. This is particularly important for obstetrics because of the complex cooperation between different professional groups, the necessarily uncontrollable aspects of every birth and the active involvement of the woman giving birth during treatment.
Different health conditions of patients complicate the systematic recording and assessment of AEs [6]. The information documented in the hospital information systems (HIS), which is not primarily used to record treatment processes, further complicates the reconstruction and assessment [7]. Internationally, different approaches to capture AEs have been reported. Most studies have conducted retrospective evaluations, including the analysis of protocol and documentation systems [8,9], by considering institutionally developed quality indicators [10,11,12]. Research teams also prospectively observed the occurrence of previously defined risk factors for AEs in birth outcomes with the conclusion that more systematic and standardized approaches are needed [13].
The medical risk to the patient must be considered when assessing harm. Previous research has distinguished between person- and system-related treatment errors, and between patient- and care-related triggers (risk factors for AEs) [6,14]. Systemic triggers are attributed to organizational problems, lack of communication, differing levels of training and lack of resources, which can only be partially controlled by the hospitals [15]. The research literature does not yet provide an agreed-upon standard for defining and recording preventability. However, action is needed, as the data on the prevalence of AEs in obstetrics is still unclear and roughly estimated at 1 to 4%, about half of which are considered preventable according to studies [6,7,8,16,17]. There is no consensus on the systematic recording of preventable adverse events in obstetrics.

2. Preventable Adverse Events in Obstetrics

4.1. Operationalization of Preventability

The valid recording of the preventability of AEs requires a precise definition. Especially in perinatal centers of the highest level of care in university hospitals, there might be large proportions of patients with maternal or infant risk factors [20]. Multiple risk factors (such as obesity, diabetes, maternal age) that many women bring with them make a binary classification of the preventability of AEs difficult. At the same time, this fact emphasizes the need for a standardized, transparent assessment of preventability [21]. Their analysis can contribute significantly to prevention, i.e., more adequate management of risk factors [22]. Objectives, the selection of cases studied, methods used, and measures derived vary considerably in the literature on AEs. Some studies examine only the most serious events for their causes in the sense of a root-cause analysis to develop interventions for future prevention, while others collect the incidences from all births in a specified time frame.
Preventability is assumed for impairments due to deviation from defined standards of care. This model is used for the retrospective systematic recording of serious events, in which risk factors influencing the patient are not considered [16,19]. In most reporting systems, only serious cases are surveyed. However, improving the quality of care requires the evaluation of less severe events to identify risk factors in the field and to develop interventions.
4.2. Systematic Recording of Serious Incidents
To measure the success of a training program to reduce AEs in the United States, Pettker created an Adverse Outcome Index (AOI) in 2009 based on an external expert view. It includes 10 serious events ranging from maternal or neonatal death to severe birth injury. In addition, an anonymous reporting system for error documentation was implemented [8]. In the year 2017, the same author proposed a systematic root cause analysis following most serious events (sentinel events), such as intrapartum maternal or infant death, severe maternal morbidity, or transfusion reactions [16,19]. Retrospective analysis systematically examines factors that contributed to respective outcome. Sentinel events are documented in a low-threshold accessible recording system to make error transparency visible.

4.3. Evaluation of Adverse Events from Clinical Risk Management

A classical British study examined the approximately 9% of reported incidents at a maternity hospital for system- or person-based triggers and then performed a root cause analysis [14]. For example, person-based problems identified misinterpretation of the CTG, medication errors or delayed diagnoses, and deviations from standard operating procedures. Systemic problems included lack of equipment and staff shortages. Inefficient communication within the team was also assessed as systemic. The goal of the analysis was to develop a catalog of interventions. As in other studies, the need for a structured “reporting system” to identify management problems was emphasized [14].
A further study [9] also examined AEs reported to risk management for influencing factors, evaluating 90 obstetric cases according to a so-called “fishbone diagram” to illustrate the relationship between the triggers, occurrence, and preventability of AEs [9]. One or more possible triggers were found in 78% of cases; of these, 31% were attributed to communication problems, another 31% to clinical problems, and 18% to diagnostic problems. In 14%, patient behavior contributed to the adverse event.

4.4. Risk Factor Analysis

A Spanish study [6] examined intrinsic and extrinsic risk factors to assess AE incidence. They were categorized as care-related errors, medication errors, infections, interventions, or errors related to diagnosis. Preventability was classified according to a score of 1–6 (absent/complete evidence). A score > 4 constituted a pAE according to this definition. Preventability was most frequently found in the context of interventions [6]. 
A recent German study focused on the operationalization of the aspect of preventability and identified six patterns of errors: Organizational errors, diagnostic errors, medication errors, peripartum therapy delay, inadequate fetal monitoring, and inadequate maternal birth position [0].

4.5. Care Management Problems

A British study from the year 2000 identified risk factors in the team, work environment, or training to prevent future errors [13]. Factors that led to errors in care management were analyzed. Because the focus was on internal risk factors, patient-dependent risks were only included under the umbrella term “condition” and were not examined. The model is mainly suitable for structured retrospective management of AEs without consideration of patient-related risk factors. However, when aiming to prevent pAEs by means of communication, such patient-dependent risks and how to manage them might be key.

4.6. Prospective Analysis

The most elaborate study, with 425 patients in the USA, prospectively recorded the causes of triggers that can lead to AEs. The prospective approach also identifies factors that did not trigger a documented incident. Forster et al. compiled a list of 72 so-called trigger factors before the start of the study [7]. An obstetric professional observer team documented labor processes and trigger factors in delivery rooms, differentiated by system problems and maternal, fetal, and interventional causes.
The most common trigger was system problems at 37%, followed by maternal events at 33% and fetal events/interventions at 15% each. The decision of preventability was made consensually by an obstetric expert team after detailed case analysis when the AE was predominantly due to treatment errors [8]. From the analysis, it can be inferred that communication training and/or training to optimize documentation can reduce AEs.

4.7. Resilient Health Care

A first step for error prevention could be the retrospective evaluation of data with a focus on pAEs based on a defined list of criteria as well as the analysis of risk factors [0]. Awareness of the presence of obstetric risk factors is a key approach to reducing pAEs. A structured documentation, for example, implemented by simple checklists, helps the obstetric team to identify women with risk factors and therefore at risk for pAEs. This can improve individualized risk-adapted obstetric care.
A further approach could be a continuous training that is routinely implemented in the obstetric setting. In particular, inadequate monitoring, diagnostic and medication errors can be partly prevented with team trainings. Additionally, simulation is key to reduce pAEs, such as peripartum therapy delay, inadequate maternal birth position and other errors linked to suboptimal hand-offs, diagnostic error, inadequate fetal monitoring and medical error. All different levels and disciplines of employees need to be involved to improve interdisciplinary understanding and collaboration.
Among other things, the studies presented refer to inadequate communication as a cause of pAEs [26]. In addition, negative communication can increase the negative effects of inadequate staffing, thus leading to more risk factors such as diagnostic or medication errors due to stress levels, overwhelmed staff, inefficiency due to no or poor hand-offs or staff who is entirely unavailable. On the other hand, communication can be a crucial resource, e.g., when promoting optimal birth positions to the pregnant women or addressing and dealing with concerns. Thus, team training with the goal of safe communication in combination with a resilience-based approach is well suited for implementation in clinical obstetrics training to reduce the number of pAEs in the future, help staff work more efficiently, ensure patient safety, and reduce the risk of patients suffering from errors or the consequences of such errors [1,2,3].
 

This entry is adapted from the peer-reviewed paper 10.3390/healthcare10010097

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