Malpractice claims are filed when there is the perception that the performance of the medical practitioner was inappropriate, unskilled, or negligent.¹ There has been a growing number of claims in most countries between 1980 and 2010. ^2,3 In response to this situation, the surveillance systems of poor outcomes in healthcare have been improved. ⁴ Nevertheless, there also has been a negative impact on healthcare costs, the practice of defensive medicine, and on the wellbeing of healthcare providers, ^5-7 the specialties with higher risk of being the target of malpractice claims are: emergency medicine, gynecology and obstetrics, anesthesiology and the surgical specialties. ^3,8

One of the potential causes of malpractice claims are the poor outcomes in healthcare identified as reportable events (REs), ^9,10 or adverse events (AEs). ¹¹ REs occur in 5% to 17% of hospitalized patients and 38% to 58% are preventable. ^11,12 In obstetrics, the frequency ranges from 3% to 12%, and 54% to 70% are preventable. ^13,14 REs exhibit a mortality around 2.8% to 4% per 1000 admissions. ^15,16 The methodology to study the frequency and classification of REs is clearly described, ¹¹ as well as the research and analysis of associated factors. ¹⁷

It is important to assess the factors associated with the judicial decisions in malpractice claims, particularly when the presence of preventable REs increases the risk of an unfavorable decision. Furthermore, there is a need to identified issues to be tackled through strategies aimed at reducing the risk of patients to experience a RE and the risk of doctors to be the target of a malpractice claims. Therefore, the purpose of this study is to assess whether there is an association between the occurrence of a reportable preventable event and an unfavorable legal or ethical decision.

The qualitative variables were expressed as absolute and relative frequencies, while the quantitative variables were expressed through means and standard deviation for the normal distribution variables, and medians and interquartile ranges for the non-normal distribution variables. The normality of the variables was evaluated using the Shapiro-Wilk test. The baseline characteristics of the cases and controls were compared using Mann-Whitney or Chi-square and Fisher exact tests, based on the type of variable. The association between reportable preventable event and an unfavorable legal or ethical decision was evaluated in the bi-varied analysis through crude Odds Ratio (OR) and its corresponding 95% confidence interval (CI). Finally, to assess the association between reportable preventable event and an unfavorable legal or ethical decision, adjusted for other variables, a multivariate analysis was conducted using a non-conditional logistic regression model that included the use of a propensity score, which strengthens the validity of the study by providing even more robust estimates, allowing for the control of unknown confounding variables, considering that this is an observational study with an important risk of confounding bias. ^21,22 The propensity score was estimated for each one of the malpractice claims, including the following covariables: the type of institution, type of admission, type of lawsuit, diagnosis of the fetus, whether the event was associated with the surgical procedure, the age of the patient, and whether the doctor had a history of additional claims given that these variable were considered relevant from the clinical point of view.

These same variables were included in the logistic regression model, together with the weights of the propensity score. Since the 2 groups (cases and controls) were not matched based on the propensity score result, a non-conditional logistic regression model was used. The backward strategy was implemented for the selection of the variables in the final model. In every case a p value of less than 0.05 was considered statistically significant. The analyses were conducted using Stata 13 (StataCorp. 2013. Stata Statistical Software: Release 13. College Station, TX: StataCorp LP).

The study was evaluated by the Ethics Committee of S.C.A. R.E with minutes' number CE 201509 dated September 1, 2016. The confidentiality and privacy of the obstetricians, the institutions, the patients and persons involved in the process was insured. Being a retrospective study, informed consents were not required.

A total of 64 cases and 258 controls were included. Reportable preventable events were identified in 268 of the 322 lawsuits included (83.2%). When comparing the cases against the controls, the former had a significantly higher frequency of: reportable preventable event, private institution, contributory regimen, civil lawsuits and fetal demise. (Table 1).

Table 1

RE = reportable event.

When comparing the groups of patients with a reportable preventable event versus patients with reportable non-preventable events or without RE, there were differences in terms of rural located institution, and pre-term gestational age. No differences were found in terms of the other characteristics between the 2 groups (Table 2).

Table 2

RE = reportable event.

In terms of health care-associated deficiencies, all except for those associated with the administration of medications, were related to the reportable preventable event (Table 3) and failures in prevention and medication treatment were associated with an unfavorable legal or ethical decision (Table 4). The most frequent health care-associated failures were treatment delays (52%) or diagnostic delays (55%); and in terms of system deficiencies, the most frequent were delays associated with the management plan and communication issues (Table 5).

Table 3

RE = reportable event.

Table 4 ^*

Statistical significance (P < 0.05)

Table 5

Source: Authors.

The bivariate analysis to assess the association between preventable RE and the unfavorable legal or ethical decision showed a crude OR of 3.6 (95% CI: 1.310.4). Other factors associated with an unfavorable legal or ethical decision were being affiliated to the contributory regimen OR: 2.22 (95% CI 122-419) and management in a private institution. The multivariate analysis including 92% of the data contained in the propensity score model resulted in an OR of 4.42 (95% CI: 2.23-8.76) between the preventable RE and an unfavorable decision about the process. An important association was also identified between an unfavorable ruling and care delivered at a private institution, with civil, ethical, or administrative processes, a final diagnosis of fetal demise, and obstetrician with a history of additional claims (Table 6). Since health care-associated failures are highly aligned with the occurrence of preventable REs (exposure to be assessed), these were not included in the final model. The goodness of fit of the logistic model was assessed using the Hosmer-Lemeshow test, indicating a good adjustment (P =0.32).

Table 6

CI=confidence interval, OR=Odds ratio.

The results of this study indicate that the occurrence of a preventable RE is an independent risk factor for unfavorable legal or ethical decisions in obstetric malpractice claims in Colombia. Other factors associated with unfavorable decisions is the type of process (civil, ethical, or administrative), health care delivered at a private institution, fetal demise, and obstetrician with a history of additional claims by other patients.

With regard to the presence ofRE's in malpractice claims, the results of the study are similar to those reported by Studdert et al²³, who describe errors in the delivery of care in 72% of the claims leading to economic compensation in all specialties. This number is higher than the reported by Bishop et al, ²⁴ with 47% of AE's in malpractice claims in inpatients, both studies from the United States.

The association between preventable RE and unfavorable litigation rulings has been reported by Phillips et al²⁵. They found in a study on malpractice claims in primary care, an association between the occurrence of preventable REs and economic compensation. In obstetrics, Pettker et al²⁶ conducted a before-after study, reporting that the implementation of a broad strategy to prevent AEs in obstetrics in an institution, achieved a reduction from 30 to 14 claims between 2003 and 2007 as compared against 1998 to 2002; Ransom et al²⁷ in a case (deliveries ended up in legal claims) study and controls (deliveries that did not end up in claims with the same diagnoses as the cases) found that non-compliance with the clinical management protocols was significantly associated with malpractice claims (47% vs 11%) OR: 5.76 (95% CI 3.59, 9.2).

Regarding to fetal or newborn compromise as a risk factor for an unfavorable litigation decision, Kurki²⁸ in 1997 reported in Finland a study on 801 claims nationwide, where 85% of the claims were filed as a result of events happened during labor; the cause that led to higher economic compensation was fetal asphyxia; Hale reports that neonatal injuries are among the primary causes of obstetric claims in the United States²⁹; similar reports have been made by Domingues³⁰ (2014) in Portugal.

With regard to deficiencies in the health care management, the findings are similar to those reported by Morris et al³¹ in general surgery malpractice claims, where they find diagnostic failures, treatment delays, surveillance issues, as well as by systems failures in communication and patient management plan. Furthermore, Clark evaluated 189 claims against obstetricians in the United States and found that 75% of those that lead to an economic compensation, showed deficiencies in the health care management. ³²

Some of the strengths of this study are that both cases and controls belong to the same population; the analytical approach to this phenomenon is an additional contribution to the prevailing descriptive approach in most of the literature on the topic; the use of the propensity score who strengthens the results and reaches additional control of any confounding factors. Furthermore, the use of a validated methodology to assess REs.

Some of the limitations include the retrospective nature of the study that affects the quality of the information and could be a source of measurement and selection biases; the inability to conduct a subgroup analysis per type of litigation under the Colombian legal system. Finally, it should be highlighted that in case of claims with a high probability of an unfavorable result, occasionally the claim is settled before the court hearing in the Colombian system and therefore these situations could not be captured in this study; however, this potential bias leans the association found towards the null hypothesis.

The occurrence of preventable REs is associated with unfavorable legal or ethical decisions in civil, ethical, and administrative malpractice claims in Colombia. The outcome of a fetal demise is also associated with unfavorable rulings. Failures in patient management and in the operation of the hospital care system provide opportunities for intervention in order to reduce the risk of being subject to medical malpractice liability.

Protection of persons and animals: The authors declare that no experiments in humans or animals were conducted in this research.

Confidentiality of information: The authors declare that they have followed the protocols established in their workplace on the disclosure of patient information.

Right to privacy and informed consent: The authors declare that no patient data are included in this study.