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. 2021 Nov 29;18(4):276–286. doi: 10.1097/PTS.0000000000000917

Surgical Error Compensation Claims as a Patient Safety Indicator: Causes and Economic Consequences in the Murcia Health System, 2002 to 2018

Jorge Vicente-Guijarro ∗,†,‡, José Lorenzo Valencia-Martín ‡,§, Carlos Fernández-Herreruela ∥,, Paulo Sousa ∗∗,††, José Joaquín Mira Solves ‡‡,§§,∥∥, Jesús María Aranaz-Andrés ∗,‡,¶¶; SOBRINA Working Group
PMCID: PMC9162075  PMID: 35503970

Objectives

Compensation claims are a useful source of information on patient safety research. The purpose of this study was to determine the main causes of surgical compensation claims and their financial impact on the health system.

Methods

A descriptive observational study with analytical components was carried out on compensation claims brought against the surgical area of the Murcia Health System between 2002 and 2018. We analyzed the frequency, causes, consequences, locations and surgical settings of these claims, the time of judicial procedure, and compensation adjusted to the Consumer Price Index.

Results

There were 1172 compensation claims. “orthopedic surgery and traumatology” (27.4%), “gynecology and obstetrics” (25.7%), and “general surgery” (17.2%) were the main surgical settings involved. The most frequent causes were surgical error (42.4%) and treatment error (30.9%). The main sequelae were musculoskeletal (20.0%), neurological (17.7%), and obstetric (17.7%). The average time from incident to resolution of claims was 6.3 years. A total of 20.1% of these claims were successful, particularly those involving retained surgical foreign bodies (71.4% successful claims; P < 0.001). The total compensation paid was €56,338,247 (an average of €17,207 per claim). Compensation was higher in cases with respiratory sequelae (median, 131,600; P = 0.033), death (75,916; P < 0.001), and neurological (60,000; P = 0.024).

Conclusions

Compensation claims associated with surgical procedures are made on a variety of grounds. They are drawn-out proceedings, and patients are only successful in 20% of cases.

Key Words: specialties, surgical; administrative claims, health care; patient safety; malpractice; retrospective studies; humans; Spain

Patient safety has become increasingly important in recent decades.1 It has been the subject of international initiatives promoted by prestigious institutions,2,3 to the extent that it is now an essential facet for providing quality health care.

This additional emphasis is partly due to the highly complex nature of current medical practice, which not only uses increasingly effective technologies but also has greater potential for incidents related to patient safety,4 which, if they cause harm, are classed as adverse events (AEs).5 These incidents can lead to disparities between patient expectations and perception of the quality of care received, resulting in patient dissatisfaction with the health system.6 As a result of this disappointment, patients may decide to file claims for medical negligence.7 In Spain, when patients file claims against the public health system and seek compensation because their rights have been violated, these are treated as claims for compensation (CCs) and administrative litigation, which may be referred to the courts. If the court finds that the care provided by the administration was below expectations, the medical care delivered will be judged negligent,8 and the court will find in favor of the plaintiff.

In this context, an estimated 50% of compensation claims for inadequate health care involve a failure to follow recommendations published in clinical practice guidelines or unnecessary treatment.9 In turn, claims for alleged medical negligence are more common in the case of surgery,10 particularly in disciplines such as “orthopedic surgery and traumatology” (OST)11 and “gynecology and obstetrics” (GO).9,12

Furthermore, incidents and their resulting compensation claims can have negative consequences for all parties: for the patients who are directly affected; for health care professionals who are second victims, for possible work anxiety related to the event13; and for health institutions as third victims, for the damage to their reputations and possible financial repercussions.14

As a result, incidents and CCs may be an additional financial cost for the health care system: first, because of the need to treat AEs and their complications, which may entail carrying out of new procedures not initially foreseen15; second, because of the phenomenon of defensive medicine, medical practitioners perform unnecessary procedures to avoid exposure to malpractice litigation16; and third, the cost of paying compensation if the claims are resolved in favor of patients, which are borne partially or entirely by the health system. For example, it was estimated that the amount value of compensation in Spain was more than €183,000 in obstetrics from 1986 to 2010,12 €81,000 in OST from 1995 to 2011,11 €50,000 in vascular surgery from 1986 to 2009,17 and €19,500 in maxillofacial surgery from 1990 to 2014.18

All this makes CCs a valuable source of information to study the adequacy of clinical practice and identify of potential patient safety issues,19 an analysis that has been recommended in several documents in the Spanish government’s Patient Safety Strategy for the National Health System.20,21

The aim of this study was to identify the main causes of compensation claims in the surgical setting by means of an analysis of predisposing incidents and to study the financial consequences of their compensation on the health system.

METHODOLOGY

Study Design

We conducted an observational descriptive study with analytical components carried out on the CCs against the surgical activities of the Murcia Health System (MHS) between 2002 and 2018. The MHS is the public health service of the Region de Murcia, an autonomous community of Spain that is geographically located in the southeast territory of the country, covering more than 1000 km2 and with a population of around 1.5 million inhabitants. According to the Statistical Platform of the Spanish government, in 2018, the MHS had 4759 functional beds distributed for 12 hospitals and performed 62,429 surgeries and 1,102,645 medical consultants.22

To this end, we carried out a cross-sectional analysis of the information registered by the MHS as of August 12, 2019. The study population consisted of all CCs made between January 1, 2002, and December 31, 2018, to health care services of the surgical area of the region of Murcia. This included all health care forms related to the surgical activity, such as surgical interventions, consultations, hospital admissions and stays, and preoperative and postoperative care. Nonsurgical and operative claims (damage resulting from poor maintenance, loss, or breakage of personal objects, etc) were excluded because these were not considered to have been directly derived from the care activity.

All data were classified, with the exception of the descriptions of the trigger events, which were recorded in free-text format by MHS administrative staff, and amounts of compensation, which were recorded as quantitative variables.

Analysis Plan

Depending on their status at the study date (August 12, 2019), claims were classified as follows: “successful claims” (SCs), if the court found in favor of the plaintiff, awarding compensation; “unsuccessful claims” (UCs), if the court found in favor of the health system, denying compensation; and “undecided” (CPD), if the claim was pending a decision.

The causal events were considered patient safety incidents, classified as incidents without damage in the UC and incidents with damage (AEs) in SC, following the taxonomy established by the Conceptual Framework for the International Classification for Patient Safety, developed by the World Health Organization.5

The causes of the incidents were classified as follows: “difficulty accessing health care,” “surgical errors,” “diagnostic delay,” “treatment delay,” “diagnostic error,” “treatment error,” and “others,” with a single option being allocated to each claim.

Simultaneously, based on the text describing the event, all claims were coded by category (“presence”/“absence”) to the following: (1) complementary causal factors, including “defects in informed consent (IC),” “retained surgical foreign bodies,” “incident resulting from a cesarean section,” and “hysterectomy-related incidents; (2) consequences of the incident, including “death,” “reintervention,” “amputation,” “musculoskeletal,” “cardiovascular,” “maxillofacial,” “gynecological,” “obstetric,” “gastrointestinal,” “metabolic,” “respiratory,” “ophthalmology,” “otorhinolaryngology,” “urological,” “neurological,” “hysterectomy,” “infection” (stratified into “nonseptic infection” and “sepsis”), and “dermatological” (stratified into “aesthetic except for burns”); and (3) whether the patient was attended in a second health care center involved in the medical activity described in the claim, according to the management system of this second center, such as “public management” and “private management.”

A descriptive analysis was performed for each variable by calculating frequency estimators with their respective 95% confidence intervals (95% CIs). The analysis was performed overall and then stratified according to its status or resolution as SC, UC, or CPD.

All compensations awarded were corrected to its equivalent 2019 value according to the variation of the National General Consumer Price Index system, established by the Instituto Nacional de Estadística Español (Spanish National Statistics Institute).

Measures of central tendency and dispersion (mean, typical SD, and 95% CI; median, quartile 1 [Q1], and quartile 3 [Q3]) of compensation for SC were calculated and stratified for each available variable.

Elapsed time (median, Q1, and Q3) was estimated between the following 3 events: date on which the incident occurred, date of filing the CC, and CC resolution date. To minimize a possible underestimation of these times, because it was not possible to include the values of any claims still unresolved on the study date, only those years for which more than 80% of CCs were resolved were included in this analysis (these were from 2002 to 2013).

Bivariate Analysis

The distribution of CC was analyzed and stratified according to the outcome of the CC (SC, UC, or CPD) and the associated surgical setting (“general surgery” [GS], OST, and GO) and classified according to the following aspects: year of claim against the health system; causes, consequences, and location of the triggering incident; related surgical specialty; and the existence of a second involved health center.

Qualitative variables were compared using the χ2 parametric test; and in the case of noncompliance with the application scenario for this parametric test, we used Fisher exact test. We compared the quantitative data (median times and costs) with polyatomic qualitative variables using the nonparametric Kruskal-Wallis test; and we used the Mann-Whitney U test for the comparison with dichotomous variables. We did a simple linear regression between the cost of the compensation of the SC and the year this was imposed on the MHS. Confidence intervals at 95% (α = 0.05) and significant P value for frequency estimates were estimated. Differences with P values less than 0.05 were considered statistically significant. The statistical exploitation of the data was carried out using the Stata v.13 statistical software.23

RESULTS

Over the 17 years studied, 1172 compensation claims were brought against the MHS. Of the total number of compensation claims involved, most were associated with surgical incidents (42.4%; n = 497), treatment errors (30.9%; 362), and diagnostic errors (16.3%; 191); OST (27.4%; 321), GO (25.7%; 301), and GS (17.2%; 201) were the most frequent surgical settings (Table 1). The most frequent consequences were musculoskeletal (20.0%; 234), neurological (17.7%; 207), and obstetric (17.2%; 201) (Table 2).

TABLE 1.

Breakdown of Compensation Claims Brought Against the MHS Between 2002 and 2018, Depending on the Presence or Absence of Certain Causes and Consequences of the Associated Incident

Total CC CC Resolved TIR, Claims Allowed
n % n % (Over Total CC) Median (Q1–Q3), y n % (CI 95%) (Above Total CC Resolved), % P (Allowed CC % Difference)
Total 1172 782 66.7 6.3 (4.2–8.2) 157 20.1 (17.4–23.0)
Year of CC
 2002 33 2.8 27 81.8 8.9 (3.0–13.8) 12 44.4 (26.9–63.5) 0.001*
 2003 37 3.2 34 91.9 4.2 (3.0–11.8) 6 17.6 (8.0–34.4)
 2004 39 3.3 35 89.7 10.8 (6.5–12.0) 5 14.3 (6.0–30.4)
 2005 69 5.9 64 92.8 8.4 (4.7–10.1) 8 12.5 (6.3–23.2)
 2006 48 4.1 39 81.3 9.5 (8.5–10.7) 3 7.7 (2.5–21.6)
 2007 31 2.6 30 96.8 7.4 (6.4–8.8) 5 16.7 (7.0–34.7)
 2008 64 5.5 57 89.1 7.2 (5.3–8.2) 9 15.8 (8.4–27.8)
 2009 81 6.9 72 88.9 6.3 (4.9–8.2) 18 25.0 (16.3–36.3)
 2010 109 9.3 101 92.7 6.3 (4.9–7.6) 15 14.9 (9.1–23.2)
 2011 88 7.5 76 86.4 5.7 (3.8–7.5) 24 31.6 (22.1–42.9)
 2012 20 1.7 17 85.0 3.5 (2.7–4.5) 6 35.3 (16.3–60.4)
 2013 56 4.8 45 80.4 4.2 (2.8–5.6) 8 17.8 (9.1–31.9)
 2014 70 6.0 47 67.1 — 10 21.3 (11.8–35.4)
 2015 105 9.0 64 61.0 — 19 29.7 (19.7–42.0)
 2016 124 10.6 46 37.1 — 9 19.6 (10.4–33.7)
 2017 94 8.0 18 19.1 — 0 0.0 (0.0–18.5)
 2018 104 8.9 10 9.6 — 0 0.0 (0.0–30.8)
Cause of incident
 Surgical error 497 42.4 268 53.9 6.3 (4.3–8.2) 64 23.9 (19.1–29.4) 0.433
 Treatment error 362 30.9 296 81.8 6.6 (4.0–8.4) 58 19.6 (15.4–24.5)
 Diagnostic error 191 16.3 153 80.1 5.7 (4.6–7.7) 25 16.3 (11.3–23.1)
 Treatment delay 46 3.9 21 45.7 5.2 (3.6–5.9) 3 14.3 (4.5–36.9)
 Diagnostic delay 42 3.6 21 50.0 7.1 (4.7–9.5) 5 23.8 (10.0–46.7)
 Others 30 2.6 21 70.0 4.0 (2.8–5.7) 2 9.5 (2.3–32.0)
 Denial of care 4 0.3 2 50.0 6.3 (0.0–0.0) 0 0.0 (0.0–84.2)
Incident location
 Outpatient care (includes consultations) 650 55.5 432 66.5 6.4 (4.2–8.2) 93 21.5 (17.9–25.7) 0.520
 Operating room 217 18.5 140 64.5 6.2 (4.8–7.6) 25 17.9 (12.3–25.1)
 Emergency department 157 13.4 122 77.7 5.6 (4.0–7.8) 23 18.9 (12.8–26.8)
 Labor room 107 9.1 69 64.5 6.9 (5.0–9.2) 12 17.4 (10.1–28.3)
 Ward 20 1.7 8 40.0 6.4 (2.8–9.5) 2 25.0 (5.7–64.9)
 ICU 11 0.9 1 9.1 7.6 (0.0–0.0) 1 100.0 (2.5–100.0)
 Other/Unknown 10 0.9 10 100.0 3.3 (3.3–5.3) 1 10.0 (1.2–49.6)
Surgical area
 OST 321 27.4 219 68.2 6.0 (4.0–7.9) 51 23.3 (18.1–29.4) 0.702
 GO 301 25.7 209 69.4 6.5 (4.3–8.5) 37 17.7 (13.1–23.5)
 GS 201 17.2 136 67.7 6.4 (4.0–7.8) 31 22.8 (16.5–30.6)
 Ophthalmology 70 6.0 41 58.6 6.6 (5.3–9.1) 8 19.5 (10.0–34.7)
 Urology 57 4.9 37 64.9 6.0 (5.4–9.9) 9 24.3 (13.0–40.8)
 Neurosurgery 52 4.4 37 71.2 6.4 (4.6–8.6) 8 21.6 (11.1–37.9)
 Anesthesiology 35 3.0 17 48.6 5.1 (1.7–9.3) 2 11.8 (2.8–37.9)
 Cardiovascular surgery 33 2.8 15 45.5 5.5 (4.8–7.2) 2 13.3 (3.2–41.9)
 Maxillofacial surgery 30 2.6 20 66.7 5.0 (2.8–6.4) 5 25.0 (10.5–48.5)
 Otorhinolaryngology 29 2.5 20 69.0 5.7 (2.5–5.9) 1 5.0 (0.7–29.4)
 Plastic surgery 19 1.6 13 68.4 7.4 (3.6–13.3) 1 7.7 (1.0–41.1)
 Dermatology 10 0.9 6 60.0 4.7 (2.7–8.6) 0 0.0 (0.0–45.9)
 Vascular surgery 7 0.6 5 71.4 6.5 (4.1–8.5) 1 20.0 (2.1–74.4)
 Thoracic surgery 5 0.4 5 100.0 8.3 (0.0–0.0) 1 20.0 (2.1–74.4)
 Pediatric surgery 2 0.2 2 100.0 0.0 (0.0–0.0) 0 0.0 (0.0–84.2)
Total 1172 782 66.7 6.3 (4.2–8.2) 157 20.1 (17.4–23.0)
Open in a new tab

P for percentage difference: using χ2 tests (if parametric test conditions are met) and Fisher exact test (nonparametric). To minimize a possible underestimation of the compensation claims, because it was not possible to include the values of claims still open at the study date, only those years where more than 80% of claims were concluded were included in this analysis (these were from 2002 to 2013).

*P < 0.05.

ICU, intensive care unit; n, sample; % (CI 95%), percentage (expected interval of such percentage with a confidence of 95%); SUR, surgery, TIR, time from incident to claim resolution.

TABLE 2.

Breakdown of Compensation Claims Brought Against the MHS Between 2002 and 2018, Depending on the Presence or Absence of Certain Causes and Consequences of the Associated Incident

Presence Absence
Total CC CC Resolved TIR CC Allowed Total CC CC Resolved TIR CC Allowed P (% Presence Versus Absence of CC)
n % n % (Over Total CC) Median (Q1–Q3), y n % (CI 95%) (Above Total CC Resolved), % n % n % (Over Total CC) Median (Q1–Q3), y n % (CI 95%) (Above Total CC Resolved), %
Circumstances causes incident
 Cesarean section 60 5.1 35 58.3 7.1 (3.1–8.8) 5 14.3 (6.0–30.4) 1112 94.9 747 67.2 6.3 (4.2–8.1) 152 20.3 (17.6–23.4) 0.382
 Defective informed consent 31 2.6 23 74.2 7.1 (4.2–8.2) 6 26.1 (12.0–47.8) 1141 97.4 759 66.5 6.2 (4.2–8.2) 151 19.9 (17.2–22.9) 0.465
 Retained surgical foreign bodies 25 2.1 21 84.0 5.5 (2.0–8.2) 15 71.4 (47.8–88.7) 1147 97.87 761 66.3 6.3 (4.2–8.2) 142 18.7 (16.0–21.6) <0.001†
 Hysterectomy 20 1.7 13 65.0 6.8 (5.8–8.8) 3 23.1 (7.2–53.5) 1152 98.3 769 66.8 6.3 (4.1–8.1) 154 20.0 (17.3–23.0) 0.731
Incident consequences
 Musculoskeletal 234 20.0 169 72.2 5.9 (3.8–8.1) 37 21.9 (16.3–28.8) 938 80.0 613 65.4 6.3 (4.3–8.2) 120 19.6 (16.6–22.9) 0.505
 Neurological 207 17.7 132 63.8 6.9 (4.9–8.6) 33 25.0 (18.3–33.1) 965 82.3 650 67.4 6.1 (3.9–8.0) 124 19.1 (16.2–22.3) 0.121
 Obstetric 201 17.2 138 68.7 6.7 (4.3–9.0) 20 14.5 (9.5–21.4) 971 82.8 644 66.3 6.1 (4.0–8.0) 137 21.3 (18.3–24.6) 0.071
 Death 133 11.3 78 58.6 6.5 (4.8–7.5) 18 23.1 (15.0–33.8) 1039 88.7 704 67.8 6.2 (4.1–8.2) 139 19.7 (17.0–22.9) 0.486
 Global infections 109 9.3 59 54.1 6.6 (5.1–7.5) 7 11.9 (5.7–23.0) 1063 90.7 723 68.0 6.2 (4.1–8.2) 150 20.7 (17.9–23.9) 0.101
 Nonsepsis infection 68 5.8 42 61.8 6.4 (5.1–7.7) 3 7.1 (2.3–20.2) 1104 94.2 740 67.0 6.2 (4.1–8.2) 154 20.8 (18.0–23.9) 0.029*
 Sepsis 41 3.5 17 41.5 6.6 (4.7–7.1) 4 23.5 (8.8–49.5) 1131 96.5 765 67.6 6.3 (4.2–8.2) 153 20.0 (17.3–23.0) 0.759
 Gynecological 98 8.4 75 76.5 5.8 (3.8–7.1) 13 17.3 (10.3–27.7) 1074 91.6 707 65.8 6.3 (4.3–8.3) 144 20.4 (17.6–23.5) 0.533
 Reintervention 96 8.2 63 65.6 6.0 (3.9–7.3) 14 22.2 (13.6–34.2) 1076 91.8 719 66.8 6.3 (4.2–8.2) 143 19.9 (17.1–23.0) 0.658
 Gastrointestinal 90 7.7 66 73.3 6.5 (4.8–7.7) 16 24.2 (15.3–36.1) 1082 92.3 716 66.2 6.3 (4.1–8.2) 141 19.7 (16.9–22.8) 0.377
 Ophthalmic 79 6.7 46 58.2 6.3 (5.2–9.2) 9 19.6 (10.4–33.7) 1093 93.3 736 67.3 6.3 (4.1–8.1) 148 20.1 (17.4–23.2) 0.929
 Urology 71 6.1 51 71.8 6.2 (5.3–8.9) 8 15.7 (8.0–28.5) 1101 93.9 731 66.4 6.3 (4.1–8.1) 149 20.4 (17.6–23.5) 0.418
 Otorhinolaryngology 39 3.3 28 71.8 5.7 (3.3–6.3) 2 7.1 (1.7–25.0) 1133 96.7 754 66.5 6.3 (4.2–8.2) 155 20.6 (17.8–23.6) 0.094
 Maxillofacial/mouth 38 3.2 22 57.9 4.2 (1.1–6.3) 4 18.2 (6.8–40.3) 1134 96.8 760 67.0 6.3 (4.3–8.2) 153 20.1 (17.4–23.1) 1
 Dermatological 37 3.2 24 64.9 5.8 (2.7–8.2) 5 20.8 (8.8–41.9) 1135 96.8 758 66.8 6.3 (4.2–8.2) 152 20.1 (17.3–23.1) 0.925
 Burns 15 1.3 9 60.0 5.8 (2.7–10.5) 4 44.4 (16.5–76.4) 1157 98.7 773 66.8 6.3 (4.2–8.2) 153 19.8 (17.1–22.8) 0.085
 Other aesthetic 22 1.9 15 68.2 5.8 (2.7–8.2) 1 6.7 (0.9–36.9) 1150 98.1 767 66.7 6.3 (4.2–8.2) 156 20.3 (17.6–23.3) 0.327
 Surgery 34 2.9 24 70.6 4.4 (3.0–5.5) 5 20.8 (8.8–41.9) 1138 97.1 758 66.6 6.3 (4.3–8.2) 152 20.1 (17.3–23.1) 0.925
 Respiratory 24 2.0 17 70.8 7.1 (6.1–7.6) 7 41.2 (20.5–65.5) 1148 98.0 765 66.6 6.2 (4.1–8.2) 150 19.6 (16.9–22.6) 0.028*
 Amputation 19 1.6 15 78.9 6.6 (4.8–7.8) 4 26.7 (10.0–54.4) 1153 98.4 767 66.5 6.3 (4.2–8.2) 153 19.9 (17.3–22.9) 0.517
 Hysterectomy 12 1.0 6 50.0 5.0 (3.1–6.9) 0 0.0 (0.0–45.9) 1160 99.0 776 66.9 6.3 (4.2–8.2) 157 20.2 (17.5–23.2) 0.606
 Metabolic 4 0.3 2 50.0 - 0 0.0 (0.0–84.2) 1168 99.7 780 66.8 6.3 (4.2–8.2) 157 20.1 (17.5–23.1) 1
Second center involved
 Public management 403 34.4 205 50.9 6.7 (5.3–8.4) 48 23.4 (18.1–29.7) 769 65.6 577 75.0 6.1 (3.8–8.0) 109 18.9 (15.9–22.3) 0.165
 Private management 163 13.9 88 54.0 7.4 (5.8–10.7) 25 28.4 (19.9–38.8) 1009 86.1 694 68.8 6.1 (4.0–8.0) 132 19.0 (16.3–22.1) 0.038*
Open in a new tab

P for percentage difference: using χ2 tests (if parametric test conditions are met) and Fisher exact test (nonparametric). To minimize a possible underestimation of the compensation claims, because it was not possible to include the values of claims still open at the study date, only those years where more than 80% of claims were concluded were included in this analysis (these were from 2002 to 2013).

*P < 0.05.

†P < 0.001.

n, sample; % (CI 95%), percentage (expected interval of such percentage with a confidence of 95%), TIR, time from incident to claim resolution.

Of the 301 compensation claims involving GO, 66.8% (201) were related to the obstetric setting, 19.9% (60) involved cesarean sections, 5.3% (16) were in response to a suspected defective hysterectomy, and 4.0% (12) were the result of a previous incident. No statistically significant differences were found in the analysis of these compensation claims when compared according to SC and UC.

The average time from incident to resolution of compensation claims was 6.3 years (Q1–Q3, 4.2–8.2 years), which was higher for SC than for UC (6.4 years compared with 6.2 years; P = 0.383). The median time from the date of the incident to filing the compensation claim was 1.0 years (0.8–2.1 years). From the filing of the compensation claim to judgment, the average time was 4.3 years (2.4–5.9 years).

Of the 782 compensation claims that had been decided at the study date, 20.1% (157) were found in favor of the plaintiff. In contrast, 79.9% (625) were dismissed in favor of the administration. At the study date, none of the compensation claims filed in 2017 or 2018 had been won by the plaintiffs (Table 1). The CC resolved as SC most frequently and statistically significant were those due to “retained surgical foreign bodies” (71.4% compared with 18.7% for other causes; P < 0.001), those related to sequelae of the respiratory system (41.2% compared with 19.6%; P = 0.028), and those with a second involved center of private management (28.4% versus 19%; P = 0.038). In contrast, those described as a “nonseptic infection” were seen to be less frequent than those that did not include this consequence (7.1% versus 20.8%; P = 0.029; Table 2). No statistical significance was obtained in the comparison between SC and UC in the other variables; the “estimation” of CC resulting from errors during surgery was more frequent (23.9%), diagnostic delays (23.8%), treatment errors (19.6%), and diagnostic errors (16.3%; P = 0.433; Table 1).

The OST, GO, and GS surgical settings accounted for 70.3% of all the claims filed, and 23.3%, 17.7%, and 22.8% of compensation claims made, respectively, were successful. The percentage of SC brought because of “sepsis” was higher in GS (9.7% compared with 0.0% in OST and GO; P = 0.016), as were those based on “death” (32.3% in GS compared with 13.5% in GO and 0.0% in OST; P < 0.001). The AE leading to compensation claims occurred most frequently in the GS operating room (83.9% compared with 51.0% in OST and 35.1% in GO). In comparison, 33.3% of OST SCs occurred in emergency care and 32.4% in GO in the delivery room (P < 0.001). On the other hand, the average costs of compensation for these SCs were 51,779 for GS, 31,320 for GO, and 12,348 for OST (P = 0.001; Table 3).

TABLE 3.

Distribution of the Characteristics of the “Allowed” Resolved Compensation Claims Submitted to the MHS From 2002 to 2016 and Related to the Field of GS, OST, or GO

OST GO GS
n % (CI 95%) n % (CI 95%) n % (CI 95%) P
Total 51 37 31 0.315
Cause of incident
 Surgical error 16 31.4 (19.9–45.7) 15 40.5 (25.5–57.6) 16 51.6 (33.6–69.2) 0.077
 Treatment error 16 31.4 (19.9–45.7) 17 45.9 (30.1–62.6) 11 35.5 (20.1–54.5)
 Diagnostic error 16 31.4 (19.9–45.7) 4 10.8 (3.9–26.5) 2 6.5 (1.5–23.9)
 Treatment delay 1 2.0 (0.3–13.4) 1 2.7 (0.3–18.3) 1 3.2 (0.4–21.6)
 Diagnostic delay 1 2.0 (0.3–13.4) 0 0.0 (0.0–9.5) 1 3.2 (0.4–21.6)
 Others 1 2.0 (0.3–13.4) 0 0.0 (0.0–9.5) 0 0.0 (0.0–11.2)
Circumstances causes*
 Cesarean section — — 5 13.5 (5.6–29.1) — — —
 Retained surgical foreign bodies 1 2.0 (0.3–13.1) 5 13.5 (5.6–29.1) 4 12.9 (4.8–30.3) 0.076
 Informed consent 2 3.9 (1.0–14.7) 1 2.7 (0.4–17.5) 1 3.2 (0.4–20.5) 1
 Hysterectomy — — 3 8.1 (2.6–22.8) — — —
Consequence incident*
 Musculoskeletal 37 72.5 (58.5–83.2) 0 0.0 (0.0–9.5) 0 0.0 (0.0–11.2) <0.001†
 Neurological 12 23.5 (13.7–37.3) 8 21.6 (11.0–38.1) 3 9.7 (3.1–26.7) 0.283
 Obstetric 0 0.0 (0.0–7.0) 20 54.1 (37.8–69.5) 0 0.0 (0.0–11.2) <0.001†
 Gastrointestinal 0 0.0 (0.0–7.0) 0 0.0 (0.0–9.5) 16 51.6 (34.1–68.7) <0.001†
 Death 0 0.0 (0.0–7.0) 5 13.5 (5.6–29.1) 10 32.3 (18.0–50.8) <0.001†
 Gynecological 0 0.0 (0.0–7.0) 12 32.4 (19.2–49.3) 0 0.0 (0.0–11.2) <0.001†
 Reintervention 3 5.9 (1.9–17.0) 2 5.4 (1.3–19.7) 4 12.9 (4.8–30.3) 0.501
 Infection 2 3.9 (1.0–14.7) 0 0.0 (0.0–9.5) 3 9.7 (3.1–26.7) 0.129
  - Sepsis 0 0.0 (0.0–7.0) 0 0.0 (0.0–9.5) 3 9.7 (3.1–26.7) 0.016‡
  - Nonseptic infection 2 3.9 (1.0–14.7) 0 0.0 (0.0–9.5) 0 0.0 (0.0–11.2) 0.506
 Surgery 1 2.0 (0.3–13.4) 0 0.0 (0.0–9.5) 3 9.7 (3.1–26.7) 0.062
 Amputation 4 7.8 (2.9–19.4) 0 0.0 (0.0–9.5) 0 0.0 (0.0–11.2) 0.124
 Dermatological 0 0.0 (0.0–7.0) 1 2.7 (0.4–17.5) 2 6.5 (1.5–23.9) 0.108
  - Burns 0 0.0 (0.0–7.0) 1 2.7 (0.4–17.5) 1 3.2 (0.4–21.6) 0.324
  - Nonburn aesthetic 0 0.0 (0.0–7.0) 0 0.0 (0.0–9.5) 1 3.2 (0.4–21.6) 0.261
 Urological 0 0.0 (0.0–7.0) 3 8.1 (2.6–22.8) 0 0.0 (0.0–11.2) 0.045‡
 Respiratory 1 2.0 (0.3–13.4) 2 5.4 (1.3–19.7) 0 0.0 (0.0–11.2) 0.470
 Otorhinolaryngology 0 0.0 (0.0–7.0) 0 0.0 (0.0–9.5) 2 6.5 (1.5–23.9) 0.066
 Ophthalmology 1 2.0 (0.3–13.4) 0 0.0 (0.0–9.5) 0 0.0 (0.0–11.2) 1
Incident location 0 0.0 (0.0–0.0) 0 0.0 (0.0–0.0) 0 0.0 (0.0–0.0)
 Outpatient care (includes consultations) 7 13.7 (6.5–26.6) 7 18.9 (9.0–35.6) 3 9.7 (2.9–27.4) <0.001†
 Labor room 0 0.0 (0.0–7.0) 12 32.4 (18.9–49.7) 0 0.0 (0.0–11.2)
 Operating room 26 51.0 (37.1–64.7) 13 35.1 (21.1–52.4) 26 83.9 (65.4–93.5)
 ICU 0 0.0 (0.0–7.0) 1 2.7 (0.3–18.3) 0 0.0 (0.0–11.2)
 Emergency department 17 33.3 (21.5–47.7) 3 8.1 (2.5–23.3) 1 3.2 (0.4–21.6)
 Other/Unknown 1 2.0 (0.3–13.4) 0 0.0 (0.0–9.5) 0 0.0 (0.0–11.2)
 Ward 0 0.0 (0.0–7.0) 1 2.7 (0.3–18.3) 1 3.2 (0.4–21.6)
Second center Involved* 0 0.0 (0.0–0.0) 0 0.0 (0.0–0.0) 0 0.0 (0.0–0.0)
 Public management 20 39.2 (26.5–53.6) 9 24.3 (12.8–41.4) 5 16.1 (6.5–34.6) 0.080
 Private management 9 17.6 (9.2–31.1) 3 8.1 (2.6–22.8) 4 12.9 (4.8–30.3) 0.434
Compensation costs
 Median (Q1–Q3), € — 12,348 (3656–31,141) — 31,320 (3048–255,000) — 51,779 (13,281–76,716) 0.032‡
 Mean€ — 28,544.98 — 176,653.80 — 68,686.64
  <1500 5 9.8 (4.0–22.0) 9 24.3 (12.8–41.4) 3 9.7 (2.9–27.4) 0.001‡
  1500–50,000 36 70.6 (56.3–81.7) 11 29.7 (16.8–47.0) 12 38.7 (22.7–57.6)
  >50.000 10 19.6 (10.7–33.3) 17 45.9 (30.1–62.6) 16 51.6 (33.6–69.2)
Total 51 0.0 (0.0–0.0) 37 0.0 (0.0–0.0) 31 0.0 (0.0–0.0)
Open in a new tab

P for percentage difference: using χ2 tests (if parametric test conditions are met) and Fisher exact test (nonparametric). P for cost difference: using the Kruskal-Wallis test (nonparametric). The amounts of compensation awards were corrected to their equivalent 2019 value according to the variation of the National General Consumer Price Index system.

*Variables that include more than one option. For example, a CC can be logged as an incident that has had more than one type of consequence. Therefore, the sum of the values of these variables may be greater than the total number of claims analyzed.

†P < 0.001.

‡P < 0.05.

ICU, intensive care unit; n, sample; % (CI 95%), percentage (expected interval of such percentage with a confidence of 95%).

The total cost of compensation associated with SC was €56,338,247 for the entire period studied, which averaged €3,314,015 per year. The median compensation was €17,207 (Q1, €3,708; Q3, 72,030) and the average of €358,842. A total of 49.7% of SC were settled with compensation ranging from €50,000 to €1500, 35.0% costing more than €50,000, and 15.3% with less than €1500.

Statistically significant differences were found when comparing the cost of compensation according to the years included in the study (P = 0.017), but not in the linear regression between the 2 variables (P = 0.236). The highest cost of compensation was seen in cardiovascular surgery (median, €70,800), followed by anesthesiology (€60,720) and GS (€51,779) (P = 0.055). No statistically significant differences were found in the comparison of compensation according to the cause or location of the AE (Table 4).

TABLE 4.

Costs Associated With Compensation of the Allowed Resolved CCs Filed With the MHS Between 2002 and 2018, Depending on the Year the Case Is Brought and the Cause and Location of the AE, the Surgical Setting, and Surgical Area

Total Compensation Cost
n Median (Q1–Q3), € Mean, € P
Total 157 17,207 (3,708–72,030) 358,842
Year of CC
 2002 12 3497 (899–176,119) 106,674 0.017*
 2003 6 1935 (583–13,281) 23,681
 2004 5 106,535 (75,117–635,400) 375,053
 2005 8 20,786 (8267–500,477) 219,125
 2006 3 87,932 (14,693–102,900) 68,508
 2007 5 309 (276–1444) 3589
 2008 9 17,207 (9642–43,227) 77,302
 2009 18 16,281 (3138–61,270) 51,679
 2010 15 18,754 (10,460–62,580) 39,754
 2011 24 10,412 (3473–41,549) 33,415
 2012 6 10,645 (3656–78,740) 54,846
 2013 8 27,463 (10,661–50,416) 29,870
 2014 10 50,402 (24,223–101,000) 107,424
 2015 19 34,627 (10,000–131,600) 2,380,398
 2016 9 10,689 (3280–90,900) 130,034
Cause of AE
 Surgical error 64 15,768 (3928–66,350) 81,759 0.315
 Treatment error 58 14,137 (1357–78,740) 97,059
 Diagnostic error 25 20,213 (7774–72,030) 60,537
 Treatment delay 3 50,308 (40,640–60,163) 50,370
 Diagnostic delay 5 62,580 (49,229–97,045) 8,758,946
 Others 2 8504 (6314–10,694) 8504
Location of AE
 Outpatient care (includes consultations) 93 14,693 (3239–67,512) 77,820 0.388
 Operating room 25 29,007 (3099–72,030) 1,790,560
 Emergency department 23 16,688 (9642–30,480) 40,890
 Labor room 12 118,940 (2318–468,150) 239,009
 Ward 2 51,500 (34,627–68,372) 51,500
 ICU 1 423,600 423,600
 Other/Unknown 1 1836 1836
Surgical area
 OST 51 12,348 (3656–31,141) 28,545 0.055
 GO 37 31,320 (3048–255,000) 176,654
 GS 31 51,779 (13,281–76,716) 68,687
 Ophthalmology 8 1856 (300–14,455) 9478
 Urology 9 52,300 (25,214–67,512) 4,887,598
 Neurosurgery 8 14,035 (10,577–75,256) 91,953
 Anesthesiology 2 60,720 (24,395–97,045) 60,720
 Cardiovascular surgery 2 70,800 (10,000–131,600) 70,800
 Maxillofacial surgery 5 18,222 (3099–208,600) 226,184
 Otorhinolaryngology 1 8526 8526
 Plastic surgery 1 10,689 10,689
 Vascular surgery 1 3708 3708
 Thoracic surgery 1 262 262
Total 157 17,207 (3708–72,030) 358,842
Open in a new tab

P for cost difference: using the Kruskal-Wallis test (nonparametric). The amounts of compensation awards were corrected to their equivalent 2019 value according to the variation of the National General Consumer Price Index system.

*P < 0.05.

ICU, intensive care unit; n, sample; SUR, surgery;* <0.05.

Median expenditure was higher in SC whose AE had neurological consequences (median of €60,000 compared with €15,768 without that sequelae; P = 0.024), respiratory (€131,600 versus €16,688; P = 0.033), or ended in death (€75,916 versus €13,581; P < 0.001). However, the cost of compensation was lower in the case of musculoskeletal consequences (€10,460 compared with €29,846; P = 0.012) or ophthalmic (€1444 compared with €19,484; P = 0.003) consequences (Table 5).

TABLE 5.

Costs Associated With Compensation of the Allowed Resolved CCs Filed With the MHS Between 2002 and 2018, Depending on the Presence or Absence of Certain Causes and Consequences of the Associated Incident

Presence Absence P
(Allowed CC Cost Presence Versus absence)
n Median (Q1–Q3), € Mean, € n Median (Q1–Q3), € Mean, €
Circumstances causes AE
 Cesarean section 5 16,688 (6436–106,535) 70,940 152 17,714 (3682–70,201) 368,313 0.830
 Informed consent 6 9786 (1444–12,187) 16,004 151 18,754 (3708–75,117) 372,465 0.205
 Retained surgical foreign bodies 15 16,688 (4450–29,212) 52,834 142 18,488 (3656–76,716) 391,167 0.587
 Hysterectomy 3 24,527 (3048–78,450) 35,342 154 17,126 (3708–72,030) 365,144 0.959
Consequence AE
 Musculoskeletal 37 10,460 (3889–20,213) 23,176 120 29,846 (3494–91,170) 462,339 0.012*
 Neurological 33 60,000 (10,694–123,850) 139,845 124 15,768 (3260–60,688) 417,124 0.024*
 Obstetric 20 143,898 (1375–370,650) 251,114 137 16,688 (3889–60,163) 374,569 0054
 Death 18 75,916 (50,308–102,900) 86,255 139 13,581 (3135–60,106) 394,141 <0.001†
 Total infections 7 24,223 (3000–97,045) 42,965 150 17,126 (3708–72,030) 373,583 0.970
  - Mild infection 3 10,000 (300–24,223) 11,508 154 17,714 (3708–73,010) 365,609 0.251
  - Sepsis 4 81,116 (34,094–99,022) 66,558 153 17,045 (3708–68,372) 366,484 0.344
 Gynecological 13 9567 (3048–16,688) 17,836 144 19,562 (3873–75,916) 389,628 0.069
 Reintervention 14 21,953 (1775–60,106) 34,996 143 17,207 (3708–73,010) 390,548 0.669
 Gastrointestinal 16 46,228 (13,987–74,064) 56,326 141 16,688 (3280–68,372) 393,170 0.175
 Ophthalmology 9 1444 (442–10,000) 8586 148 19,484 (4224–75,916) 380,142 0.003*
 Urological 8 43,463 (13,494–69,983) 5,478,020 149 16,688 (3708–72,030) 83,987 0.460
 Otorhinolaryngology 2 94,139 (56,595–131,682) 94,139 155 17,045 (3656–72,030) 362,258 0.181
 Maxillofacial 4 10,661 (2050–113,411) 57,730 153 17,207 (3858–72,030) 366,715 0.632
 Dermatological 5 8526 (6436–9,673) 15,440 152 18,488 (3682–74,064) 370,139 0.215
  - Burns 4 9100 (7481–30,726) 19,104 153 18,222 (3656–73,010) 367,724 0.525
  - Other aesthetic 1 783 783 156 17,714 (3783–72,520) 361,138 0.139
 Surgery 5 9111 (3708–68,372) 36,680 152 17,714 (3757–72,520) 369,440 0.639
 Respiratory 7 131,600 (31,141–423,600) 252,131 150 16,688 (3656–65,188) 363,822 0.033*
 Amputation 4 40,742 (16,897–155,900) 86,399 153 17,045 (3656–72,030) 365,965 0.300
 Hysterectomy 0 — — 157 17,207 (3708–72,030) 358,842 —
 Metabolic 0 — — 157 17,207 (3708–72,030) 358,842 —
Second center involved
 Public management 48 17,056 (5172–60,717) 76,459 109 17,207 (3135–73,010) 483,195 0.912
 Private management 25 27,729 (10,460–87,932) 1,838,136 132 16,688 (3137–70,201) 78,673 0.166
Open in a new tab

P for cost difference: using the Mann-Whitney U test (nonparametric). The amounts of compensation awards were corrected to their equivalent 2019 value according to the variation of the National General Consumer Price Index system.

*P < 0.05.

†P < 0.001.

N, sample.

DISCUSSION

The secondary use of CC records allowed us to analyze the frequency and characteristics of possible patient safety problems, with these sources of information, which although not specifically designed for that purpose, being proven useful in this field in other previous studies.18,24

Malpractice during a health intervention was the main ground for bringing CC (42.4%). However, a great variation in this result has been observed in other studies carried out in Spain in maxillofacial surgery (65.1%),18 vascular surgery (31.85%),17 and overall (22.2%).25 On the other hand, patient death was responsible for 11.3% of the CC, being this a lower percentage than that found globally in the United States (26%)26 and in neurosurgery in Spain (22%).27 In contrast, the percentage of CC filed as a result of a burn (1.3%) was very similar to that obtained in the United States (1.9%).28 Some of these defects may be due to a failure to follow the recommendations of clinical practice guidelines or prescription of unjustified treatments.9

Concerning the surgical settings, this study is consistent with 2 other studies carried out in Spain, placing the OST and GO areas as those in which a greater number of complaints were filed.10,12 In OST, a slight variation of the results was observed when compared with another study carried out by Cardoso-Cita et al11 over a similar period of duration (17 years, from 1995 to 2011), because this study found higher percentages of musculoskeletal disorders (72.5% compared with 43.6%), but fewer neurological events (23.5% versus 34.0%), infections (3.9% versus 11.9%), and deaths (0.0% versus 6.6%).

In GO, compared with the study by Gómez-Durán et al12 on CC filed in this field with the Catalonian Health System between 1986 and 2010, a slightly higher percentage of CC was obtained by the obstetric area (66.8% compared with 61.9%) and cesarean sections (18.9% compared with 12.8%). On the other hand, when compared with Norway,9 fewer SCs were obtained associated with a surgical procedure (40.5% compared with 67.6%), a diagnostic error (10.8% compared with 17.0%), or a diagnostic delay (0.0% compared with 22.4%). It should be noted, however, that only gynecology-associated CCs were included in this study, when more than half of CC and GO belonged to the obstetric setting.

On the other hand, the percentage of CC related to defective IC (2,6%) was lower than those derived from OST (14.9%)11 and neurosurgery (16.7%)27 interventions in Spain, but similar to that found in maxillofacial surgery services (3.8%).18 Similarly, it was also lower than that of endoscopic processes in the United States (42%),29 and hip arthroplasties (13.3%)30 and overall (6%)31 in the Netherlands. However, the percentage of these CC decided in favor of the individual was consistent with that obtained by the Dutch study (26.1% compared with 25%).31 The role of the IC is spatially important in the surgical field because, in Australia, 57% of IC-related CCs were brought against surgeons and 71% claimed insufficient information on risks and complications arising from the surgical intervention.32 Another cause of the inadequacy of IC could be its inappropriate form of administration because, in Spain, up to 58.1% of health professionals in the surgical field could have a misunderstanding of this practice, especially among those with more than 16 years of work experience.33

The percentage of CC filed for retained surgical foreign bodies decided in favor of the individual (71.4%) agrees with that obtained in another study carried out in Spain in the field of GO (71.7%).12 The causes of this type of incident have been studied in the United States, where it was associated with urgent operations, unexpected changes in surgical techniques, and high body mass index,34 with surgical sponges being the most frequently forgotten surgical material, before clamps and needles.34–36 To try to prevent these incidents, several prestigious institutions, such as the American College of Surgeons37 or the Joint Commission International Center for Patient Safety,38 have disseminated specific improvement strategies, including surgical material counts and measures to improve communication among health care professionals during surgical procedures.

Regarding the financial impact of the CC studied, the general costs obtained (median, €17,207; average, €358,842) echo those found in the United States between 1991 and 2005 (median, $111,749; average, $274,887)39 and between 1992 and 2014 (average, $329,565).40 In the stratified analyses, when comparing the surgical settings with other approximations performed in Spain, the compensation obtained in this study was higher in maxillofacial surgery (average, €226,184 versus €19,639)18 and lower in OST (average, €28,545 versus €81,767)11 and GO (average, €31,320 compared with €96,426 in obstetrics and €28,776 in gynecology).12 On the other hand, in neurosurgery, we found an average (€14,035) lower than other studies in Spain (66.7% of the compensation claims >€60,000)27 and in the United Kingdom (GBP 203,158).41 However, the comparison of these values presents several difficulties because not all studies use the same dispersion measures (medians or means; when the compensation tends to adopt a nonnormal distribution) and does not apply corrections to final costs according to temporary economic variations (such as the Consumer Price Index), in addition to the fact that the amounts may be influenced by the different health management systems (public administration versus private management). In addition, the cost of compensation can be assumed partially or totally by the different health systems, depending on whether they have a damage liability insurance policy and the conditions of the policy. This could result in similar compensation figures eventually affecting the various health services unevenly.

The median time between the incident and the resolution of the compensation claim (6.3 years) is in an intermediate position between the one found in the United States (4 years)26 and that obtained throughout Spain (7.2) and Massachusetts (United States; 7.0) between 2002 and 2012.25 Although this study only analyzed this aspect in years with more than 80% of resolved compensation claims, the different values available in the scientific literature may be slightly understated, as they cannot include the claim resolution times still open at the study date. In any case, the long duration observed to process and resolve claims could cause additional stress to the patient42 and health care professionals (as a second victim),13 as well as a delay in the implementation of possible improvements in patient safety if only safety incidents associated with closed CC were analyzed.

On the other hand, the low proportion of SCs decided for the plaintiff, of the total claims filed (20.1%), is a frequent finding in both national and international studies.9,10,12,18 This result is consistent with another study carried out in Mexico with claims from 1996 to 2008, where there were possible indications of malpractice in only 20.8% of records,43 whereas in neurosurgery in Spain, the percentage of “complete malpractice” was slightly higher at 28.3%.27 This phenomenon could be explained by high patient expectations of success, a concept contemplated by the Spanish jurisprudence in a ruling that, according to the Lex Artis ad hoc of the health care sector, “the responsibility of the Health System is the logical consequence that characterises the public health service as a provider of means, and in no case a guarantor of results.”44 This dimension does not interfere with the nature of the IC, which must provide information to the patient about possible risks, therapeutic alternatives, and other circumstances inherent in each intervention, but does not guarantee a specific clinical benefit.45 Besides, according to this jurisprudence, it could be considered that, in those SCs, there was a lack of provision of resources or improper use of them, producing inappropriateness of health care, because of a medical practice underuse, overuse, or misuse.46,47

In turn, the existence of claims has been linked to defensive medicine, which interferes with the usual clinical practice of health professionals and the efficiency of the health system. In Spain, up to 8% of claims of a health area were brought based on a specialist’s refusal to grant a patient’s request,48 whereas in a 2017 survey, surgeons and anesthetists assigned a score of 7.5 (on a scale of 1 to 10) to impact of defensive medicine on the overuse of the health system, 20% of them acknowledging that they had recommended unnecessary medical procedures for fear of being sued.33 However, this percentage is lower than that obtained in Italy (33%)49 or the United States (84.7%),50 where 39% of professionals would also avoid performing specific medical procedures on high-risk patients because of fear of legal consequences, and defensive medicine was related to lack of confidence in health insurance.51 However, despite this influence on real clinical practice, there is no evidence linking higher health spending with a reduction in medical negligence claims.16

Strengths and Weaknesses of the Study

The CCs analyzed pertain to a single region of Spain, with its own health system and sociodemographic idiosyncrasies, which may limit the external validity of the results obtained.

Data for CCs were logged by administrative personnel, not by health professionals, so the correct coding of some difficult-to-interpret values could not be ensured. That said, the classifications derived from the description of the CC were carried out and reviewed in detail by the research team.

The sample comprised all CCs brought against the MHS for 17 years, which avoided possible selection bias, ensuring sufficient statistical power, and allowed us to analyze the existence of temporal variations.

Similarly, adjusting the cost of compensation according to the Consumer Price Index and selecting the years with more than 80% of closed CCs for the analysis of resolution times improved the internal and external validity of the study.

CONCLUSIONS

The main grounds for bringing CC were incidents resulting from surgical operations and treatment errors, with surgical settings related to OST, GO, and GS being the most frequently affected. Musculoskeletal, neurological, and obstetric sequelae are the most frequent, followed by deaths and infections.

Only 1 in 5 CCs are decided in favor of the plaintiff, with those involving “retained surgical foreign bodies” having the highest likelihood of success. The median time from incident to resolution of the CC was 6.3 years, similar to that obtained in other national and international studies.

Compensation costs due to health care delivered were high, averaging out at more than €3 million per year. This cost is higher in claims because of neurological, respiratory, or death consequences, and lower in musculoskeletal or ophthalmic consequences. As a result, incidents and their associated CC have major consequences on patients, professionals, and health systems and cause high economic costs that are borne by the public health system, either directly or through possible purchases of liability insurance.

ACKNOWLEDGMENTS

Thanks to Instituto de Salud Carlos III for the funding of this research through the project PI16/00971 (cofunded by European Regional Development Fund, “A way to make Europe”).

Footnotes

SOBRINA Working Group: Yolanda Agra Varela, Julián Alcaraz Martínez, Verónica Aranaz, Ana Mª Ariztegui Echenique, Mª Pilar Astier Peña, María Concepción Carratalá Munuera, Johanna Milena Caro Mendivelso, Irene Carrillo Murcia, Ana Mª Cebrián Cuenca, Miguel Ignacio Cuchi Alfaro, Juan Custardoy Olavarrieta, Cristina Díaz-Agero Pérez, Ana Mª Fernández Navascués, María Teresa Gea Velázquez de Castro, Javier González de Dios, Francisco Miguel González Valverde, Nieves López Freseña, Julio José López-Picazo Ferrer, Patricia López Pereira, Francisco López Rodríguez-Arias, Federico de Montalvo Jaaskelainen, Olga Monteagudo Piqueras, Isabel Mª Navarro Soler, Cristina Nebot Marzal, María Ángeles Nuin Villanueva, Guadalupe Olivera Cañadas, Pastora Pérez Pérez, Ángela Rincón Carlavilla, José María Ruiz Ortega, Ascensión, Sánchez Martínez, Carmen Silvestre Busto, María Luisa Torijano Casalengua, Julián Vitaller Burillo, Elena Zavala Aizpúrua.

This research was funded by Instituto de Salud Carlos III through the project PI16/00971 (cofunded by European Regional Development Fund, “A way to make Europe”).

Ethics Committee: This project obtained the agreement of the Site Management of the University Hospital Ramón y Cajal (Madrid, Spain) and a favorable opinion of the ethics committee of the same site (reference 168/17), dated July 31. 2017.

The authors disclose no conflict of interest.

Contributor Information

Jorge Vicente-Guijarro, Email: jorge.vicente@salud.madrid.org.

Carlos Fernández-Herreruela, Email: karlferreruela@gmail.com.

Paulo Sousa, Email: Paulo.Sousa@ensp.unl.pt.

José Joaquín Mira Solves, Email: jose.mira@umh.es.

Jesús María Aranaz-Andrés, Email: jesusmaria.aranaz@salud.madrid.org.

REFERENCES

  • 1.Lark ME, Kirkpatrick K, Chung KC. Patient safety movement: history and future directions. J Hand Surg Am. 2018;43:174–178. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 2.Institute of Medicine (US) Committee on Quality of Health Care in America . To Err Is Human: Building a Safer Health System. Washington, DC: National Academies Press (US); 2000. Available at: http://www.ncbi.nlm.nih.gov/books/NBK225182. Accessed September 2, 2020. [PubMed] [Google Scholar]
  • 3.World Health Organization . World Alliance for Patient Safety: Forward Programme, 2005. Geneva, Switzerland: World Health Organization; 2004. [Google Scholar]
  • 4.Chantler C. The role and education of doctors in the delivery of health care. Lancet. 1999;353:1178–1181. [DOI] [PubMed] [Google Scholar]
  • 5.World Health Organization . Conceptual Framework for the International Classification for Patient Safety. Versión 1.1. Final Technical Report. 2009. Available at: https://www.who.int/patientsafety/implementation/taxonomy/icps_technical_report_es.pdf. Accessed December 10, 2020.
  • 6.Mira JJ, Aranaz J. Patient satisfaction as an outcome measure in health care. Med Clin (Barc). 2000;114(Suppl 3):26–33. [PubMed] [Google Scholar]
  • 7.Orentlicher D. Medical malpractice: treating the causes instead of the symptoms. Med Care. 2000;38:247–249. [DOI] [PubMed] [Google Scholar]
  • 8.Leape LL Brennan TA Laird N, et al. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. N Engl J Med. 1991;324:377–384. [DOI] [PubMed] [Google Scholar]
  • 9.Ravlo M Lieng M Khan Bukholm IR, et al. Approved claims for compensation from gynecological patients in Norway—what characterizes the cases? A 14-year nationwide study. Acta Obstet Gynecol Scand. 2019;98:1070–1076. [DOI] [PubMed] [Google Scholar]
  • 10.Arimany-Manso J Benet-Travé J Bruguera-Cortada M, et al. Surgical procedures involved in claims for alleged defects in praxis. Med Clin (Barc). 2014;142(Suppl 2):47–51. [DOI] [PubMed] [Google Scholar]
  • 11.Cardoso-Cita Z Perea-Pérez B Albarrán-Juan ME, et al. Analysis of judicial sentences issued against traumatologists between 1995 and 2011 as regards medical negligence. Rev Esp Cir Ortop Traumatol. 2016;60:29–37. [DOI] [PubMed] [Google Scholar]
  • 12.Gómez-Durán EL Mulà-Rosías JA Lailla-Vicens JM, et al. Analysis of obstetrics and gynecology professional liability claims in Catalonia, Spain (1986–2010). J Forensic Leg Med. 2013;20:442–446. [DOI] [PubMed] [Google Scholar]
  • 13.Mira JJ Carrillo I Guilabert M, et al. The second victim phenomenon after a clinical error: the design and evaluation of a website to reduce caregivers’ emotional responses after a clinical error. J Med Internet Res. 2017;19:e203. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 14.Mira JJ Lorenzo S Carrillo I, et al. Research Group on Second and Third Victims . Interventions in health organisations to reduce the impact of adverse events in second and third victims. BMC Health Serv Res. 2015;15:341. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 15.Ministerio de Sanidad y Consumo . Revisión Bibliográfica sobre Trabajos de Costes de la “No Seguridad del Paciente”. Informes, estudios e investigación. 2008. Available at: https://www.seguridaddelpaciente.es/resources/contenidos/castellano/2008/CostesNoSeguridadPacientes.pdf. Accesed September 29, 2020.
  • 16.Jena AB Schoemaker L Bhattacharya J, et al. Physician spending and subsequent risk of malpractice claims: observational study. BMJ. 2015;351:h5516. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 17.Roche E Gómez-Durán EL Benet-Travé J, et al. Professional liability claims in vascular surgery practice. Ann Vasc Surg. 2014;28:324–329. [DOI] [PubMed] [Google Scholar]
  • 18.Bordonaba-Leiva S Gómez-Durán EL Balibrea JM, et al. Twenty four years of oral and maxillofacial surgery malpractice claims in Spain: patient safety lessons to learn. Oral Maxillofac Surg. 2019;23:187–192. [DOI] [PubMed] [Google Scholar]
  • 19.Huang Y-L, Moon J, Segal JB. A comparison of active adverse event surveillance systems worldwide. Drug Saf. 2014;37:581–596. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 20.Ministerio de Sanidad y Consumo . Secretaría General de Sanidad. Agencia de Calidad del Sistema Nacional de Salud. Estrategia en Seguridad del Paciente. Recomendaciones del Taller de Expertos celebrado el 8 y 9 de febrero de 2005. Ministerio de Sanidad y Consumo, Secretaría General Técnica (Spain); 2005. Available at: https://www.mscbs.gob.es/organizacion/sns/planCalidadSNS/pdf/excelencia/opsc_sp1.pdf. Accessed September 2, 2020.
  • 21.Ministerio de Sanidad, Servicios Sociales e Igualdad . Estrategia de Seguridad del Paciente del Sistema Nacional de Salud. Periodontics 2015–2020. 2016. Available at: https://www.seguridaddelpaciente.es/resources/documentos/2015/Estrategia%20Seguridad%20del%20Paciente%202015-2020.pdf. Accessed September 2, 2020.
  • 22.Gobierno de España . Ministerio de Sanidad. Portal Estadístico. Área de Inteligencia de Gestión. Consulta Interactiva del Sistema Nacional de Salud. Sistema de Información de Atención Especializada (SIAE). Available at: https://pestadistico.inteligenciadegestion.mscbs.es/publicoSNS/S/siae. Accessed March 25, 2021.
  • 23.StataCorp . Stata Statistical Software: Release 13. College Station, TX: StataCorp LP; 2013. [Google Scholar]
  • 24.Pegalis SE, Bal BS. Closed medical negligence claims can drive patient safety and reduce litigation. Clin Orthop Relat Res. 2012;470:1398–1404. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 25.Giraldo P Sato L Martínez-Sánchez JM, et al. Eleven-year descriptive analysis of closed court verdicts on medical errors in Spain and Massachusetts. BMJ Open. 2016;6:e011644. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 26.Studdert DM Mello MM Gawande AA, et al. Claims, errors, and compensation payments in medical malpractice litigation. N Engl J Med. 2006;354:2024–2033. [DOI] [PubMed] [Google Scholar]
  • 27.Santiago-Sáez A Perea-Pérez B Labajo-González E, et al. Analysis of judicial sentences against neurosurgeons resolved in second court of justice in Spain in the period from 1995 to 2007. Neurocirugia (Astur). 2010;21:53–60. [PubMed] [Google Scholar]
  • 28.Mehta SP Bhananker SM Posner KL, et al. Operating room fires: a closed claims analysis. Anesthesiology. 2013;118:1133–1139. [DOI] [PubMed] [Google Scholar]
  • 29.Levine EG, Brandt LJ, Plumeri P. Informed consent: a survey of physician outcomes and practices. Gastrointest Endosc. 1995;41:448–452. [DOI] [PubMed] [Google Scholar]
  • 30.Zengerink I Reijman M Mathijssen NMC, et al. Hip arthroplasty malpractice claims in the Netherlands: closed claim study 2000–2012. J Arthroplasty. 2016;31:1890–1893.e4. [DOI] [PubMed] [Google Scholar]
  • 31.Veerman MM van der Woude LA Tellier MA, et al. A decade of litigation regarding surgical informed consent in the Netherlands. Patient Educ Couns. 2019;102:340–345. [DOI] [PubMed] [Google Scholar]
  • 32.Gogos AJ Clark RB Bismark MM, et al. When informed consent goes poorly: a descriptive study of medical negligence claims and patient complaints. Med J Aust. 2011;195:340–344. [DOI] [PubMed] [Google Scholar]
  • 33.Aranaz Andrés JM Valencia-Martín JL Vicente-Guijarro J, et al. Low-value clinical practices: knowledge and beliefs of Spanish surgeons and anesthetists. Int J Environ Res Public Health. 2020;17:3556. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 34.Gawande AA Studdert DM Orav EJ, et al. Risk factors for retained instruments and sponges after surgery. N Engl J Med. 2003;348:229–235. [DOI] [PubMed] [Google Scholar]
  • 35.Cima RR Kollengode A Garnatz J, et al. Incidence and characteristics of potential and actual retained foreign object events in surgical patients. J Am Coll Surg. 2008;207:80–87. [DOI] [PubMed] [Google Scholar]
  • 36.Zarenezhad M Gholamzadeh S Hedjazi A, et al. Three years evaluation of retained foreign bodies after surgery in Iran. Ann Med Surg (Lond). 2017;15:22–25. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 37.American College of Surgeons (ACS) Committee on Perioperative Care . Revised statement on the prevention of unintentionally retained surgical items after surgery. Bull Am Coll Surg. 2016;101:50–51. [PubMed] [Google Scholar]
  • 38.Cima RR Kollengode A Storsveen AS, et al. A multidisciplinary team approach to retained foreign objects. Jt Comm J Qual Patient Saf. 2009;35:123–132. [DOI] [PubMed] [Google Scholar]
  • 39.Jena AB Seabury S Lakdawalla D, et al. Malpractice risk according to physician specialty. N Engl J Med. 2011;365:629–636. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 40.Schaffer AC Jena AB Seabury SA, et al. Rates and characteristics of paid malpractice claims among US physicians by specialty, 1992–2014. JAMA Intern Med. 2017;177:710–718. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 41.Mukherjee S, Pringle C, Crocker M. A nine-year review of medicolegal claims in neurosurgery. Ann R Coll Surg Engl. 2014;96:266–270. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 42.Grant GM O’Donnell ML Spittal MJ, et al. Relationship between stressfulness of claiming for injury compensation and long-term recovery: a prospective cohort study. JAMA Psychiat. 2014;71:446–453. [DOI] [PubMed] [Google Scholar]
  • 43.Aguirre-Gas HG Zavala-Villavicencio JA Hernández-Torres F, et al. Quality of medical care and patient surgical safety: medical error, malpractice and professional liability. Cir Cir. 2010;78:456–462. [PubMed] [Google Scholar]
  • 44.Guijosa MAM. Sobre el carácter objetivo de la responsabilidad patrimonial administrativa. Antijuridicidad y atención al tipo de funcionamiento administrativo. Rev Admin Pública. 2012;97–139. [Google Scholar]
  • 45.Cocanour CS. Informed consent—it’s more than a signature on a piece of paper. Am J Surg. 2017;214:993–997. [DOI] [PubMed] [Google Scholar]
  • 46.Chassin MR, Galvin RW. The urgent need to improve health care quality. Institute of Medicine National Roundtable on Health Care Quality. JAMA. 1998;280:1000–1005. [DOI] [PubMed] [Google Scholar]
  • 47.World Health Organization . Appropriateness in Health Care Services. 2020. Koblenz, Germany. Available at: https://www.euro.who.int/__data/assets/pdf_file/0011/119936/E70446.pdf. Accessed December 17, 2020.
  • 48.Martín-Delgado J, Carrillo I, Mira JJ. Reclamaciones por la negativa del médico de primaria a aceptar una petición del paciente. J Healthc Qual Res. 2020;35:113–116. [DOI] [PubMed] [Google Scholar]
  • 49.Vernero S, Giustetto G. A survey carried out among Italian physicians regarding non-required clinical examinations, treatments and procedures in the current clinical practice: results and considerations. Recenti Prog Med. 2017;108:324–332. [DOI] [PubMed] [Google Scholar]
  • 50.Lyu H Xu T Brotman D, et al. Overtreatment in the United States. PLoS One. 2017;12:e0181970. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 51.Studdert DM Mello MM Sage WM, et al. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. JAMA. 2005;293:2609–2617. [DOI] [PubMed] [Google Scholar]

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