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ORIGINAL RESEARCH |
From the Department of Obstetrics and Gynecology, Wayne State University School of Medicine, Bloomfield Hills, Michigan; Department of Health Management and Policy, University of Michigan, Ann Arbor, Michigan; Section of Gynecology, John D. Dingell VA Medical Center, Detroit, Michigan; Department of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts; Department of Obstetrics and Gynecology, St. Johns Health System, Detroit, Michigan; and Harvard Medical School, Boston, Massachusetts.
Address reprint requests to: Scott B. Ransom, DO, MPH, Wayne State University School of Medicine, Department of Obstetrics and Gynecology, 528 Covington, Bloomfield Hills, MI 48301; E-mail: sransom{at}med.wayne.edu.
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ABSTRACT |
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METHODS: We retrospectively identified 290 delivery-related (diagnosis-related groups 370–374) malpractice claims and 262 control deliveries at the health system during the period from 1988 to 1998. Clinical pathways for vaginal and cesarean delivery implemented in 1998 were used as a "standard of care." We compared rates of non-compliance with the pathways in the claims and control groups, calculated an odds ratio for increased risk of being sued given departure from the guideline standards, and calculated the elevated risk of litigation introduced by noncompliance. We also compared the frequencies of different types of departures across claims and control groups.
RESULTS: Claims closely resembled controls on several descriptive measures (mother’s age, location of delivery, type of delivery, and complication rates), but noncompliance with the clinical pathway was significantly more common among claims than controls (43.2% versus 11.7%, P < .001; odds ratio = 5.76, 95% confidence interval 3.59, 9.2). In 81 (79.4%) of the claims involving noncompliance with the pathway, the main allegation in the claim related directly to the departure from the pathway. The excess malpractice risk attributable to noncompliance explained approximately one third (104 of 290) of the claims filed (attributable risk = 82.6%). There were no significant differences in the types of deviation from the guidelines across claims and control groups.
CONCLUSION: In addition to reducing clinical variation and improving clinical quality of care, adherence to clinical pathways might protect clinicians and institutions against malpractice litigation. Malpractice data might also be a useful resource in understanding breakdowns in processes of care.
Recent reports by the Institute of Medicine on medical error1 and health care quality2 have refocused attention on the importance of creative approaches to quality improvement. Clinical pathways are a proven form of quality improvement innovation. They have demonstrated significant potential to change practice patterns, improve quality, reduce clinical variation, and improve financial performance—but only if they are well designed and widely followed.3–5
The successful design and implementation of clinical pathways depend on "buy in" by clinicians and health care institutions. Such acceptance is not always immediate or widespread.6 Ingrained cultural factors and physicians’ innate resistance to change have long been recognized as barriers.2,3,7 Today, there is also a growing sense that the medical malpractice system may act as an impediment.8–10
In particular, the threat of litigation appears to chill providers’ willingness to disclose instances of poor quality care, including errors, adverse events, and noncompliance with "best practices."1 Providers perceive that "anything they say can and will be used against them in a court of law." Such perceptions are not completely unfounded: Existing legal protections will not always protect reported information from legal discovery.1 But because quality improvement initiatives rely so heavily on strong baseline data, provider openness, and ongoing feedback regarding adverse outcomes and breakdowns in care processes, there is mounting concern that the specter of litigation indirectly retards progress in quality improvement initiatives.
As such concerns grow, the need to investigate opportunities for the malpractice system to exert positive rather than negative impacts on quality improvement efforts is more urgent than ever. Two clear opportunities exist. First, fear of legal exposure may actually encourage interest in quality improvement efforts. For example, if compliance with clinical practice guidelines were shown to reduce legal risk, it could speed their adoption. Physician leadership in pathway development and implementation has proven important in fostering adherence,3,7,11 but demonstration that there are tangible benefits to compliance, such as a reduction in malpractice risk, may prompt busy clinicians to redouble their efforts. Second, malpractice claims themselves may serve as a potentially valuable source of information regarding quality problems, identifying target areas for quality improvement interventions.
The implementation of a clinical pathway for obstetric care at a major academic medical center provided an excellent opportunity to investigate the malpractice system’s quality improvement–enhancing potential. Using review of medical records and malpractice claims files, we compared adherence to the pathway in a sample of deliveries that gave rise to claims with adherence in a sample of deliveries that did not trigger lawsuits. We aimed to test two hypotheses: 1) that such analyses would lend support to the disputed notion that quality improvements reduce medicolegal risk, and 2) that investigation of malpractice claims data in focused clinical areas could yield valuable and broadly representative information regarding quality problems.
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MATERIALS AND METHODS |
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In 1998, the management team of a $1.8 billion health system, responsible for the delivery of approximately 12,000 infants annually, encouraged the implementation of a clinical pathway for normal vaginal delivery and cesarean delivery. The goal of the pathway project was to develop a clinically efficient and effective care plan to boost the system’s competitiveness through improved clinical quality and reduced costs. The management team selected a physician leader and pathway administrative facilitator to lead a work group in developing common clinical pathways for the system’s three obstetric hospitals.
The work group collected information on existing pathways and analyzed current processes for development, implementation, and monitoring of pathways at each site. Benchmarks, evidence-based research, scientific articles, and background data were reviewed. The work group then developed a draft pathway and presented it to an advisory group consisting of clinical service chiefs, the director of maternal–fetal medicine, and hospital administrators from each of the three hospitals. After incorporating recommendations from the advisory group, the pathway was implemented for a 3-week pilot period. After the pilot period, the pathway was further reviewed and modified. In September 1998, the pathway was implemented on a system-wide basis.4,5
From a comprehensive insurer database, we sampled all malpractice claims filed against the health system and/or its physicians over an 11-year period (1988–1998) alleging injuries sustained during inpatient obstetric care. Specifically, we targeted all claims related to vaginal delivery and cesarean deliveries (diagnosis-related groups 370–374) as previously coded by the coding section of the medical record department. Claims were defined as any lawsuit filed against the medical center or its physicians for care provided from 1988 to 1998 for diagnosis-related groups 370–374. Using the hospitals’ discharge database, we selected a group of controls by randomly sampling and matching by year an equal number of patients discharged with these diagnosis-related groups during the same period. Finally, we checked to ensure that none of the discharges sampled as controls had led to claims or were included twice for subsequent deliveries (none had), and we obtained the associated medical records.
Using an instrument designed to extract explicit information regarding the clinical circumstances of the delivery, an obstetric nurse with experience in record review reviewed the medical records associated with the cases and controls. The instrument also directed the nurse-reviewer to judge whether the intrapartum care failed to adhere to the pathway, and if so, to specify the type of departure that occurred. The nurse-reviewer was blinded as to whether each record came from the claims or control group. After record review was complete, a physician-investigator and nurse-reviewer independently examined the claims file associated with any records in the claims group judged to involve a departure from the pathway to determine whether the allegation of negligence was related to the departure.
We described the number and types of variations that did not adhere to the clinical pathway among both claims and controls. We also calculated an odds ratio (OR) and attributable risk statistic to quantify the relationship between nonadherence and litigation exposure. Finally, we compared the types of departure across the claims and control groups.
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RESULTS |
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There were no significant differences between claims and controls with respect to mother’s age, delivery hospital, rates of cesarean delivery, or rates of complication in either vaginal or cesarean deliveries (Table 1
). Overall, 72% of deliveries (346 of 476) adhered to the applicable clinical pathway (Table 2). Noncompliance was significantly more likely among claims than controls (43.2% compared with 11.7%, P < .001). Among the 102 claims involving noncompliant care, the main malpractice allegation in 81 (79.4%) of them related directly to the departure from the pathway.
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imply that noncompliance with the clinical pathway in our retrospective analysis was associated with a nearly six-fold increase in the odds of a malpractice claim (OR = 5.76, 95% confidence interval 3.59, 9.2, P < .001). Extrapolating from the control group to estimate the total number of compliant and noncompliant deliveries during the study period, we also calculated an excess occurrence of malpractice claims among noncompliant deliveries of 6.1 claims per 1000 deliveries (82.6% attributable risk). Applying this attributable risk statistic to the malpractice claims burden overall implies that noncompliance potentially accounted for 104 (36%) of all malpractice claims filed in the study period. That is, the attributable risk statistic approximated the net preventive effect of using the clinical pathway.
Despite the large discrepancy in rates of noncompliance between claims and controls, the types of the departures that did occur were actually very similar across the two groups (Table 3). Failure to monitor the fetus was the most common type of departure from the clinical pathway among both claims (31%) and controls (32%). The other leading departures among claims were failure to complete prenatal records (9%), failure to perform cesarean delivery per pathway (9%), and failure to treat and diagnose group B streptococcus (9%). These were also the most frequent type of departures among controls. There were no statistically significant differences by type of departure across the two groups.
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DISCUSSION |
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Clearly, valid reasons will exist in some cases for deviations from the clinical pathway, such as patient allergies, comorbidities, unavailable prenatal records, and complications associated with labor and delivery. A limitation of our study is that we did not distinguish clinically appropriate departures from clinically inappropriate ones, although complication rates did not differ between the claim and control groups. Another limitation was that, because the pathway was not implemented during the period studied, it cannot be said that the malpractice claims were prompted by physicians’ non-compliance with an established guideline. However, in light of previous research, our findings certainly support this connection.12 Lastly, medical records were not available for review in some of the claims and control cases; we have no reason to believe that this would create a bias in this study.
In a study that combined claims file review and an attorney survey, Hyams and colleagues found that attorneys and courts used clinical guidelines for inculpatory and exculpatory purposes in malpractice litigation (ie, to implicate and exonerate the defendant physician).12,13 Although verifiable use of guidelines was rare in this study of claims files, many attorneys reported that their use in litigation was increasing over time. Attorneys also reported that adherence and nonadherence to guidelines tend to exert exculpatory and inculpatory influences, respectively, on negligence determinations in malpractice cases.
The evidentiary weight that courts place on adherence or nonadherence to clinical pathways and practice guidelines varies from state to state, but may be significant.6 The Maine, Florida, and Kentucky legislatures have experimented with legislation establishing adherence to guidelines in select clinical areas as an affirmative defense in malpractice litigation.14 In most states, compliance with pathways are considered relevant but not conclusive evidence of whether the physician departed from the standard of care; a judge or jury will consider the pathways along with other evidence, such as expert opinion testimony regarding prevailing medical practice.15
In summary, our findings, coupled with those of previous research and prevailing legal practices, suggest that physicians who depart from well-established clinical pathways should thoroughly describe their reasons for doing so in the medical record. Departures that are well documented and clinically appropriate should be much less likely to have inculpatory value to plaintiffs or their attorneys. More generally, our study adds to emerging evidence that departures from accepted, authoritative practice guidelines increase clinicians’ risk of being sued, whereas adherence guards against this threat. Emerging data regarding the strength of this relationship should arm physician leaders promoting adherence to best practice with powerful new incentives to convey to the clinicians whose behavior they seek to influence.
We also found indirect support for the second study hypothesis—that malpractice data could be valuable in the advancement of understanding quality problems. The general assumption is that malpractice claims are grossly unrepresentative of the epidemiology of medical injury.16 Evidence for this view comes from a series of studies showing a mismatched relationship between negligent adverse events and malpractice claims.17,18 However, the haphazardness of claiming behavior does not necessarily mean that quality-of-care problems evident in specific types of malpractice claims are not useful in understanding the etiology of medical errors.
Indeed, our findings present evidence to the contrary: Malpractice claims files may provide information regarding the specific nature of deviations from high-quality care that are generalizable to the general population of patients. Although the prevalence of departures differed significantly between claims and controls in our study, the relative frequencies of different types of departures did not. The similarity of pathway departures between claims and controls should provoke a keener interest in malpractice claims as a potentially important source of information regarding poor-quality care. In particular, claims data promises a cheaper alternative to conventional information sources, such as medical record review, because the malpractice claims process effectively "triages" information on suboptimal and substandard care from many providers and institutions into a single repository.
Commentators and policymakers continue to ponder the troubled relationship between quality improvement in health care and the malpractice system. Litigation may well be a net drag on quality improvement efforts, as some have asserted.19 However, radical change in the short or medium term appears extremely unlikely.20,21 Therefore, there is a pressing need to examine ways of harnessing the quality-improving potential of the malpractice system. This study provides suggestive evidence of the malpractice system’s potential as both an impetus for adherence to clinical pathways and an untapped source of information regarding ways to improve quality.
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Footnotes |
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doi:10.1016/S0029-7844(02)03129-0
Received August 20, 2002. Received in revised form October 23, 2002. Accepted November 13, 2002.
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REFERENCES |
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2. Institute of Medicine. Crossing the quality chasm: A new health system for the 21st century. Washington: National Academy Press, 2001.
3. Reinertsen JL. Physicians as leaders in the improvement of health care systems. Ann Intern Med 1998;128:833–8.
4. Ransom SB, Gell JW, Harrison M, McDonald F. Implementation of a clinical pathway for cesarean section. Am J Managed Care 1996;2:1374–80.
5. Ransom SB, McNeeley SG, Yono A, Ettlie J, Dombrowski MP. The development and implementation of a normal vaginal delivery clinical pathway in a large multihospital health system. Am J Managed Care 1998;4:723–7.[Medline]
6. Mello MM. Of swords and shields: The role of clinical practice guidelines in medical malpractice litigation. Univ Pa Law Rev 2001;149:645–710.
7. Wyszewiansky L, Green LA. Strategies for changing clinicians’ practice patterns. J Fam Pract 2000;49:461–4.[Medline]
8. Bovbjerg RB, Miller RH, Shapiro DW. Paths to reducing medical injury: Professional liability and discipline vs patient safety–and the need for a third way. J Law Med Ethics 2001;29:369–80.[Medline]
9. Studdert DM, Brennan TA. No-fault compensation for medical injuries: The prospect for error prevention. JAMA 2001;286:217–23.
10. Gostin LO. A public health approach to reducing medical error: Medical malpractice as a barrier. JAMA 2000;283: 1742–1743.
11. Clemmer TP, Spuhler VJ, Berwick DM, Nolan TW. Cooperation: The foundation of improvement. Ann Intern Med 1998;128:1004–9.
12. Hyams AL, Brandenburg JA, Lipsitz SR, Shapiro DW, Brennan TA. Practice guidelines and malpractice litigation: A two-way street. Ann Intern Med 1995;122:450–5.
13. Hyams AL, Shapiro DW, Brennan TA. Medical practice guidelines in malpractice litigation: An early retrospective. Health Polit Policy Law 1996;21:289–313.
14. Begel J. Maine physician practice guidelines: Implications for medical malpractice litigation. Maine Law Rev 1995; 47:70–103.
15. Kramer v. Milner, 639 N.E.2d 157 (Ill. 1994).
16. Cheney FW. The American Society of Anesthesiologists Closed Claims Project: What have we learned, how has it affected practice, and how will it affect practice in the future? Anesthesiology 1999;91:552–6.[Medline]
17. Localio AR, Lawthers AG, Brennan TA, Laird NM, Hebert LE, Peterson LM, et al. Relation between malpractice claims and adverse events due to negligence. Results of the Harvard Medical Practice Study III. New Eng J Med 1991;325:245–51.[Abstract]
18. Studdert DM, Thomas EJ, Burstin HR, Zbar BI, Orav EJ, Brennan TA. Negligent care and malpractice claiming behavior in Utah and Colorado. Med Care 2000;38: 250–60.[Medline]
19. Studdert DM, Brennan TA. No-fault compensation for medical injuries: The prospect for error prevention. JAMA 2001;286:217–23.
20. Studdert DM, Brennan TA, Thomas EJ. Beyond dead reckoning: Measures of medical injury burden, malpractice litigation, and alternative compensation models from Utah and Colorado. Indiana Law Rev 2000;33: 1643–1686.
21. Layde PM, Mass LA, Teret SP, Brasel KJ, Kuhn EM, Mercy JA, et al. Patient safety efforts should focus on medical injuries. JAMA 2002;287:1993–2001.
This article has been cited by other articles:
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  P. Robinson, X. Xu, K. Keeton, D. Fenner, T. R. B. Johnson, and S. Ransom The Impact of Medical Legal Risk on Obstetrician-Gynecologist Supply Obstet. Gynecol., June 1, 2005; 105(6): 1296 - 1302. [Abstract] [Full Text] [PDF]
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 M. A. Hall, R. A. Peeples, and R. W. Lord Jr Liability Implications of Physician-Directed Care Coordination Ann. Fam. Med, March 1, 2005; 3(2): 115 - 121. [Abstract] [Full Text] [PDF]
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