Spine surgery is a frequent source of legal complaints against neurosurgeons and orthopedic surgeons1,2 owing partly to the severity of possible complications. Studies from the United States have shown that life-threatening complications,3 intraoperative injuries, wrong-site surgeries, and retained foreign objects can occur after spine surgery.4,5 Spine surgeons are acutely aware of these risks and are dedicated to providing safe and high-quality care. Concurrently, they are aware of the medicolegal risks,6 and their perceptions may trigger defensive attitudes and practices.7,8
As such, spine surgeons and institutions must constantly question their risks and the extent to which surgical complications are preventable. Although studies from various countries have explored these questions,9–16 researchers typically applied a medicolegal lens to their analysis without applying a quality improvement or patient safety lens, which we address in this article.
A systematic, in-depth analysis of medicolegal records can produce rich contextual information about contributing factors to assist prevention efforts. The Canadian Medical Protective Association (CMPA)—a national, not-for-profit mutual defence organization offering assistance to physicians in medicolegal matters, including civil legal cases and complaints to medical regulatory authorities (Colleges)—is uniquely situated for these analyses. The wide range of issues in these matters allows for comprehensive analyses, unlike pure case law analyses. The insights gained can inform patients and help medical educators, institutions, and surgeons to identify new opportunities for enhanced patient safety. If patient safety events decrease, then the number of complaints may decrease as well.17
This two-part study describes CMPA closed cases (civil legal and College matters) involving spine surgery, both from a medicolegal and patient safety perspective. First, we conducted a 15-year trend analysis of medicolegal case rates for spine surgery and for two reference populations, for context. Next, we conducted a 5-year in-depth analysis of factors contributing to medicolegal risk in spine surgery cases according to peer experts in each case.
METHODS
We conducted a retrospective descriptive study of closed cases in the CMPA's data repository. The study included a 15-year medicolegal trend analysis and a 5-year contributing-factor analysis of spine surgery cases. The Canadian ethics review panel of the Advarra (formerly Chesapeake) Institutional Review Board, based in Aurora, Ontario and comprising Canadian members, reviewed and approved the study in compliance with Canada's Tri-Council Policy Statement on the Ethical Conduct for Research Involving Humans (TCPS 2). The CMPA funded and supported this research.
The CMPA and Medicolegal Coding
The CMPA is not an insurance company; rather, it assists physician-members by offering liability protection on a discretionary basis and providing unique education opportunities and services. The CMPA also engages in patient safety research using its own national repository of coded medicolegal data, which was the basis for our study. While the CMPA encourages members to report all medicolegal matters, physicians do so voluntarily. The repository therefore captures nearly all civil legal matters but a smaller proportion of College matters. As of May 2020, the CMPA had 100,783 physician-members, estimated as >95% of physicians in Canada.
The present study focused on data that previously underwent routine medical coding by CMPA nurse-analysts using standardized methods18–20 (Supplemental Digital Content 1-A, https://links.lww.com/BRS/B853). Notably, the CMPA's contributing factors framework18 identified patient safety indicators (e.g., injury, wrong surgery, diagnostic error) and peer expert criticisms of physicians, health care teams, and systems, respectively. Peer experts were individuals retained by a party in the case to interpret and opine on issues surrounding health care and alleged patient injuries; many were physicians, typically with similar training and experience as the physician(s) named in the case. In some College matters, peer experts were College committees.
Data Extraction
The main criterion for case inclusion was involvement of spine surgery. We identified eligible cases by extracting all cases with medical coding and at least one spine surgery code21 (Supplemental Digital Content 2, http://link-s.lww.com/BRS/B853) regardless of the named physician's specialty or inpatient/outpatient setting. Other extraction criteria are in Supplemental Digital Content 1-B, https://links.lww.com/BRS/B853.
For inclusion in the trend analysis, cases must have involved spine surgery and must have been closed by the CMPA from January 1st, 2004 to December 31st, 2018. For context, we compared against trends for CMPA members in a surgical specialty (defined by the CMPA) and for all CMPA members.
For inclusion in the contributing-factor analysis, cases must have been closed from January 1st, 2014 to December 31st, 2018. This interval reflected recent medicine while providing a reasonable number of cases for in-depth analysis. We extracted variables (Supplemental Digital Content 1-B, https://links.lww.com/BRS/B853) describing physician, patient, and medicolegal characteristics, levels of patient harm, and peer expert criticisms for all cases, not only those involving patient harm.
Data Analysis
The 15-year trend analysis focused on annual medicolegal case rates, which were the number of spine surgery medico-legal cases per physician-year of CMPA membership for self-identified neurosurgeons and orthopedic surgeons, multiplied by 1000. We fit a linear trend to these rates and calculated the annualized change rate based on that trend. We then determined the statistical significance of this change rate over time and relative to two reference populations (rates for CMPA members in a surgical specialty [defined by the CMPA] and all CMPA members, respectively) using ANOVA type III sum of squares tests and SAS software, version 9.4; P values <0.05 indicated statistical significance. For the contributing-factor analysis, we calculated descriptive statistics using an in-house data analysis tool and Microsoft Excel. Only the most frequent characteristics (top 3) and frequencies ≥10 are shown for privacy reasons. We also conducted a subgroup analysis of wrong-site surgery cases.
RESULTS
Trend Analysis
Our 15-year trend analysis included 340 distinct cases comprising civil legal and College matters. Among those, 98 neurosurgeons and 100 orthopedic surgeons were named at least once; of those two groups, 75 were named more than once (75/198, 37.9%). (As of May 2020, 13,133 physicians self-reported a surgical specialty when obtaining CMPA membership; 299 identified as a neurosurgeon and 1461 as an orthopedic surgeon.)
We observed a statistically significant decreasing trend in spine surgery medicolegal case rates at an annualized change rate of −4.7% (P = 0.0017; Figure 1). This rate was not statistically significantly different from the rate for all CMPA members in a surgical specialty (−3.0%; P > 0.05) or CMPA members overall (−2.5%; P > 0.05).
;)
Figure 1: Trend over time in the rate of spine surgery cases closed by the CMPA, 2004 to 2018. Case rates are the number of cases per physician-year of CMPA membership in a neurosurgery or orthopedic surgery specialty multiplied by 1000 for ease of interpretation; N = 340 medicolegal cases.
Contributing-factor Analysis
Over 5 years (2014–2018), the CMPA closed 24,065 civil legal and College matters, including 13,943 with information available for medical coding. Of those cases, 3740 involved a physician in a surgical specialty; 704 involved an orthopedic surgeon and 151 involved a neurosurgeon.
Of 13,943 cases with available information, 100 involved spine surgery and were eligible for inclusion. Of those, 81 were civil legal matters and 19 were College matters. Clinical encounters occurred between 1992 and 2015 inclusive. (Older cases were included either because of a delay until the statement of claim or a prolonged duration until case closure.) Civil legal matters had a median duration of 42 months (interquartile range = 32–66 months), and 40 of those matters (40/81, 49.4%) ended in a settlement.
All cases involved a neurosurgeon or an orthopedic surgeon (Table 1). Whereas most cases involved one physician (86/100, 86.0%), 10 involved two physicians (10/100, 10.0%) and four involved more than two physicians (four of 100, 4.0%). Fifteen physicians were named in more than one distinct case (15/103, 14.6%). Given each physician's earliest case, 55.3% (57/103) were 20+ years post-graduation from a medical degree (MD) at the patient encounter. Around one-half (54/103, 52.4%) practiced in Ontario, the most populous Canadian province.
TABLE 1 -
Physician Characteristics in Spine Surgery Cases Closed by the CMPA, 2014–2018, N = 103 Physicians
∗,†
| Characteristic |
No. (%) |
| Surgical or medical specialty of physician(s) named‡
|
| Neurosurgery |
44 (42.7) |
| Orthopedic surgery |
37 (35.9) |
| Other§
|
22 (21.4) |
| Years since graduating from medical school‖
|
| <10 |
14 (13.6) |
| 10–19 |
32 (31.1) |
| 20 + |
57 (55.3) |
| Geographic location of clinical encounter¶
|
| Ontario |
54 (52.4) |
| British Columbia, Alberta |
21 (20.4) |
| Saskatchewan, Manitoba, the Atlantic provinces, the Territories |
19 (18.4) |
| Quebec |
9 (8.7) |
∗Because some cases involved more than physician, the number of physicians exceeds the number of cases (N = 100).
†For physicians named in multiple cases, frequencies represent their earliest case during the study period.
‡Although all cases (N = 100) included a named neurosurgeon or orthopedic surgeon, the sum of physicians in these categories is less than 100 (44 + 37 = 81) because some were named in multiple cases.
§Residents/fellows, family medicine, anesthesiology, emergency medicine, internal medicine, infectious diseases, diagnostic radiology, and surgical office practice.
‖Refers to the time between graduating from a medical degree (MD) and the date of the clinical encounter in the medicolegal case.
¶Grouped according to the CMPA's membership fee regions.
Each case featured one patient (Table 2). Fifty-nine patients underwent surgery as treatment for nerve compression disorders, and 53 (53/59, 89.8%) had elective surgery. Of 42 procedures that were extradural decompressions of the spinal cord or nerve root, 33 (33/42, 78.6%) were elective; typically in those cases, the surgeon used an open approach (40/42 patients) as opposed to a minimally invasive approach.
TABLE 2 -
Patient Characteristics in Spine Surgery Cases Closed by the CMPA, 2014–2018, N = 100 Patients
| Characteristic |
No. (%) |
| Self-reported sex |
| Male |
63 (63.0) |
| Female |
37 (37.0) |
| Age |
| 0–18 |
6 (6.0) |
| 19–29 |
8 (8.0) |
| 30–49 |
42 (42.0) |
| 50–64 |
28 (28.0) |
| 65+ |
16 (16.0) |
| ASA status∗
|
| ASA I |
13 (13.0) |
| ASA II |
55 (55.0) |
| ASA III, IV, V, or E |
20 (20.0) |
| Unknown†
|
12 (12.0) |
| Risk factors documented in the medical record |
| Obesity |
11 (11.0) |
| Previous spinal surgery |
10 (10.0) |
| Top indications for surgery‡
|
| Nerve compression disorders: myelopathy and/or radiculopathy |
59 (59.0) |
| Disc disorders: displacement, herniation, degeneration, bulging |
52 (52.0) |
| Degenerative diseases of the spine: stenosis, spondylolisthesis, spondylosis |
33 (33.0) |
| Spine deformity: acquired or congenital |
11 (11.0) |
| Acute injuries: fractures of the spine, injuries to nerves and/or spinal cord |
10 (10.0) |
| Top surgical procedures‡
|
| Extradural decompression of spinal cord or nerve root |
42 (42.0) |
| Fixation of spinal vertebrae |
32 (32.0) |
| Fusion of spinal vertebrae |
25 (25.0) |
| Excision, partial, intervertebral disc |
24 (24.0) |
| Repair of spinal vertebrae |
22 (22.0) |
∗ASA, American Society of Anesthesiologists classification of preoperative physical status.
†Information on ASA status was unclear or missing from the medicolegal case documentation.
‡Some patients had more than one indication for surgery and/or more than one type of surgical procedure; therefore, the sum of frequencies does not equal 100. Only categories with a frequency ≥10 are shown.
In 89 of the 100 cases (89.0%), there was clear documentation of health care-related harm; that is, harm associated with the provision of health care rather than underlying disease or injury (see Supplemental Digital Content 3, https://links.lww.com/BRS/B853 for breakdown of harm). Among these cases, clinical encounters occurred between 1998 and 2014. Twenty-two patients (22/89, 24.7%) died or experienced severe harm, such as paraplegia, quadriplegia, or cauda equina syndrome. In 56 cases (56/89,62.9%), peer experts concluded that the standard of care was not met; in others (33/89, 37.1%), they deemed harm to be an inherent risk, meaning it was a known risk of undergoing the procedure under ideal conditions (defined in Supplemental Digital Content 3, https://links.lww.com/BRS/B853). Of 40 cases ending in a civil legal settlement, 37 (92.5%) involved harm when the standard of care was not met.
The most frequent patient safety indicator was an intraoperative injury, in nearly one-third of cases with harm (29/89, 32.6%). Fourteen cases featured diagnostic issues (see Table 3 for examples), and 16 wrong-site surgeries occurred between 2005 and 2015 inclusive. Few cases (<10) involved unnecessary surgery, according to peer experts, or a retained foreign body.
TABLE 3 -
Top Patient Safety Indicators in Spine Surgery Cases With Health Care-related Harm Closed by the CMPA, 2014–2018, N = 89 Patients
| Patient Safety Indicator |
No. (%) |
Standard of Care Not Met, No. (%) |
Inherent Risk,∗ No. (%) |
Examples |
| Intraoperative injury†
|
29 (32.6) |
13 (14.6) |
16 (18.0) |
• Damage to the dura or nerve while drilling or during retraction |
| Wrong level or side‡
|
16 (18.0) |
16 (18.0) |
0 (0.0) |
• Surgery one level lower than intended |
| Diagnostic error |
14 (15.7) |
14 (15.7) |
0 (0.0) |
• Misdiagnosing the indication for surgery• Misinterpreting an intraoperative x-ray• Delayed response to signs and symptoms of a surgical complication |
∗Based on peer expert opinion, an inherent risk is a harmful incident that is a known risk associated with a particular investigation, medication, or treatment. It is the risk from undergoing a procedure in ideal conditions, performed by qualified staff using present research, equipment, and techniques.
†Intraoperative injuries to the dura, nerve roots, cranial nerves, spinal cord, blood vessels, thoracic/abdominal organs.
‡A wrong side surgery was surgery performed on the left side of the spine instead of the right, or on the right side of the spine instead of the left.
Our analysis of peer expert criticisms suggested a variety of factors contributed to medicolegal risk. Nearly three-quarters of the cases (73/100, 73.0%) had at least one criticism. In 71 of those, the criticism aligned with one or more phases of surgical care (Figure 2 shows criticisms in rank order of frequency). The most frequent criticisms related to physician clinical decision-making; namely, failing to perform diagnostic tests when indicated (20/100 cases, 20.0%) and deficient patient assessments (17/100 cases, 17.0%). Multiple cases involved surgeons deviating from a standard protocol or checklist (10/100, 10.0%). Peer experts noted communication breakdowns with other providers (< 10 cases overall) and inadequate documentation (14/100 cases, 14.0%). They also noted communication breakdowns with patients (<10 cases) and were critical of informed consent processes (14/100 cases, 14.0%). For example, they noted surgeons explaining only generic risks of surgery, omitting patient- or procedure-specific risks. Peer experts also noted system issues such as unavailable resources, malfunctioning equipment, and appointment overbooking (overall 10/100 cases, 10.0%).
Figure 2: Top peer expert criticisms in 71 spine surgery cases closed by the CMPA, 2014–2018. Criticisms appear in order of decreasing frequency, from top to bottom, for providers, teams, and systems, respectively. Cases may have had criticisms in multiple phases of care.
Sixteen cases featured wrong-site spine surgery (Figure 2). In wrong-level surgeries, peer experts noted surgeons not performing imaging at the right time or not following intraoperative imaging checklists or protocols (10/100 cases, 10.0%); some noted software issues with a navigation device (<10 cases). In all of the wrong-side surgeries, peer experts noted teams not collectively confirming the correct side before the first incision (<10 cases).
DISCUSSION
Over 15 years of closed cases at the CMPA, there was a decrease in the annual rate of spine surgery medicolegal cases, not unlike trends for CMPA members in the surgical specialties or CMPA members overall. Recent cases were serious, however, with 89.0% of patients experiencing health care-related harm, including quadriplegia and death. Furthermore, 81.0% of recent cases involved civil legal matters, with a median duration of 3.5 years. Peer expert criticisms addressed all phases of care and frequently related to clinical decision-making.
It is unclear why medicolegal case rates decreased between 2004 and 2018. There is evidence that the types of spine surgery procedures have changed over time. Data from the Canadian Institute for Health Information (unpublished, from a CMPA analysis made possible through a datasharing agreement) suggests there was an increase in the number of in-hospital spine surgery procedures in Canada (from 27,989 to 34,337 per year between fiscal years 2008/09 and 2017/18) but a decrease in decompressions of the spinal cord or nerve root—the top procedure in our contributing-factor analysis—from 3560 to 2226 per year. The Canadian Classification of Health Interventions (CCI) defines this procedure in a hierarchy of decompression codes as “spinal cord release that involves repaired damage to the spinal cord or nerve root” and “the most invasive form of decompression.”21 The decreasing trend might reflect the use of more complex instrumented surgeries over time, perhaps involving other types of decompression. With increasing surgical complexity, however, a decreasing medicolegal trend seems counterintuitive.
Still our trend analysis suggests that decreasing medico-legal case rates were not unique to spine surgery since the rates also decreased for other CMPA members. We are not aware of any significant changes to the civil justice system between 2004 and 2018 that would explain this finding, such as a change in Canadian tort law. With respect to the informed consent process, we are not aware of any major changes in practice. Other countries have also seen decreasing medicolegal trends. For example, in a German study of spine surgery claims filed free-of-charge to a state medical council, there was a decrease in claims between 2012 and 2017.10 Also in the United States, medical professional liability case rates decreased between 2007 and 2016,22 and the annual rate of claims paid on behalf of neurosurgery and orthopedic physicians decreased between 1992 and 2014.6
One possible reason for the change may be that increasingly, due to the cost of litigation, patient complaints were resolved through other channels besides legal action against physicians. Additionally, it is possible that a growing awareness of medicolegal risks expanded the adoption of defensive medicine, as for spine surgeons in the United States,23 although this is difficult to prove and defensive attitudes may be less prominent in Canada than the United States.24 Still this growing awareness may have led spine surgeons to adapt certain other practices to mitigate risk such as engaging in a more thorough informed consent process.25 Despite medicolegal differences by jurisdiction, and even if the majority of cases against spine surgeons were successfully defended, the experience of litigation brings on monetary, time, and social stress that surgeons may have been trying to avoid through practice adaptations where possible.
Spine surgery safety may have improved in this time. For example, it is plausible that improvements may have resulted from new intraoperative imaging modalities, navigation/image guidance, and minimally invasive surgery, which, compared to open surgery, relies more on intraoperative imaging. Safety may have improved from more physicians subspecializing in spine surgery or becoming aware of safety risks (e.g., for wrong-level surgery). Notably, the World Health Organization's surgical safety checklist was implemented in Canada around 2010.26 Although one study suggested a lack of impact from the checklist, further evaluation is needed.27
In our 5-year contributing-factor analysis, intraoperative injury was the top patient safety indicator, as in previous studies featuring intraoperative injuries12,14,15 or procedural errors.9,10,15 In approximately one-half of our intraoperative injury cases (16/29; 55.2%), however, peer experts deemed injury to be an inherent risk of care. We did not find surgeons’ lack of technical training or inadequate trainee supervision to be top contributing factors, and over one-half of the physicians (55.3%) had 20+ years of experience (Table 1). Lack of experience did not appear to be a major factor.
Instead, top criticisms reflected physicians’ clinical decision-making: namely, deficient patient assessments and failures to perform diagnostic tests. Other criticisms were surgeons deviating from intraoperative checklists or protocols, and communication breakdowns. In theory, all of these factors can delay problem identification before, during, or after surgery.28 Diagnostic errors (e.g., of an intraoperative injury) were prominent in our study, as in previous reports,9–14 and peer experts consistently viewed these cases as falling below the standard of care.
There are options for enhancing clinical decision-making. For one, researchers suggest that recognizing cognitive biases and practicing reflectively (e.g., by asking, ”What else could this be?”) may improve clinical reasoning.28 This practice could lead to more-appropriate diagnostic test-ordering and preoperative examinations resulting in better patient selection and surgical decision-making. Generally speaking, an institutional culture of psychological safety and ”speaking up”29 can enhance decision-making by raising situational awareness. Team training programs, such as TeamSTEPPS30 and TeamSTEPPS Canada31 have been developed to improve team collaboration and communication. Structured communication tools32,33 and checklists may also raise situational awareness.
Wrong-site surgeries in our study were associated with factors already identified in the literature.34,35 Given these factors, it is possible that surgical safety checklists could be customized to prevent wrong-site spine surgery. For example, teams could verbally confirm the laterality and spinal level intraoperatively for multi-level operations in addition to the sign-in and time-out. Time-outs could further include patient-specific risks for wrong-level surgery, patient-specific plans for identifying the correct level, and preparedness for intraoperative imaging. Healthcare Excellence Canada encourages adaptations of the checklist and offers guidance for implementation.36
Regarding contributing factors, it is possible that some of the factors we identified would be less frequent in other types of medicolegal data given that most of our cases (81/100) were civil legal cases in a tort-based system requiring proof of negligence, as in the UK and Australia, for example. Caution is needed when extrapolating our ranking of contributing factors to other countries with different medicolegal environments.
Our study had noteworthy limitations. In the contributing-factor analysis, we lacked information about patient risk factors, team dynamics, and each surgeon's patient volume and case mix. Also, we could not demonstrate causation between medicolegal risk and surgeon, patient, or procedure characteristics—only associations. Moreover, despite the rigor of the CMPA's methods for medical coding, we acknowledge the possibility of coding errors and that peer expert opinions are prone to hindsight bias and outcome bias.37
Regarding generalizability to the rest of Canada, our trend analysis underestimated medicolegal rates since the CMPA captures only a proportion of College matters. Additionally, our contributing-factor analysis could not estimate the frequency of surgical errors because a multitude of factors can motivate a patient's decision to complain, and physicians inadvertently may not recognize all errors. Instead, we provided qualitative insights from a select subgroup of events. Furthermore, our data may underrepresent the prevalence of team- and system-related issues given the CMPA's focus on physicians. Finally, because of lag times until case closure we may not have captured all current issues facing spine surgeons in clinical practice today.
CONCLUSION
By applying a patient safety lens to our analysis, we were able to provide data beyond a summary of case law. Although medicolegal rates for spine surgery decreased over time, patient harm was attributable to health care in the majority of recently closed cases. Therefore, crucial opportunities remain for medical educators, institutions, and surgeons to enhance spine surgery safety.
A combination of strategies could improve patient safety. First, our results support medical education for spine surgeons on the topic of clinical decision-making. Second, institutions could consider fostering inter-professional communication through team training, to support surgeons in decision-making. Third, we urge surgical leaders to reassess and optimize their local systems for preventing wrong-site spine surgery. As one step towards this goal, the surgical safety checklist36 could be adapted to address patient-specific risk factors for wrong-level spine surgery and preparedness for identifying the site. As spine surgery safety improves, we expect that so too will the medicolegal risks for spine surgeons.Key Points
- A retrospective descriptive study was conducted to understand closed medicolegal cases involving spine surgery in Canada.
- Although spine surgery case rates decreased over time, patient harm was attributable to health care in the majority of recently closed cases.
- Recently closed cases involved intraoperative injuries, diagnostic errors, and wrong site surgeries.
- Crucial opportunities remain to enhance patient safety in spine surgery.
Acknowledgments
The authors thank Syeda Faisal, Jun Ji, and Richard Liu for analytical support; Sara Khangura for reviewing the study protocol and draft manuscripts; Marie Primeau-Maurice for producing the figures; Donna Zuccala for describing spine surgery intervention codes; and Ria De Gorter for supporting the manuscript submission process. The authors also thank the Data Capture team in the department of Medical Care Analytics at the CMPA for medicolegal coding.
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