Dr KS Dhillon FRCS
Introduction
In medical negligence claims the plaintiff (patient) has to prove that the doctor owed him a duty of care, the doctor breached the duty and the breach caused damage. In medical negligence, there is no doubt that the doctor owes the patient a duty of care. This duty is to ‘exercise reasonable care and skill in diagnosing, advising and treating the patient’ (1).
A patient with osteoarthritis of the knee presents to the surgeon with knee pain after having a short course of conservative treatment. Surgeon A tells the patient that he will need an arthroscopic joint debridement which is quite a straight forward procedure and that would take care of the problem. Surgeon B, on the other hand, has a discourse with the patient about the disease and tells him that arthroscopic surgery is of no proven value in the treatment of OA and that he should persist with conservative treatment and eventually the pain will settle. He also tells the patient that surgery can be associated with complications which sometimes can be very serious.
Is there is any doubt about which surgeon the patient will choose? Surgeon A is practicing opinion based medicine while surgeon B is practicing evidence-based medicine. Surgeon A relied on what he learnt in postgraduate medical school and from his mentors/peers in arriving at a management decision while surgeon B relied on evidence-based information in arriving at a decision. This decision making is taken into consideration in the standard of care analysis by the courts to assess whether the surgeon exercised reasonable care and skill.
What is evidence based medicine?
Many physicians have been and are still practicing medicine based on, what they learned in medical schools, on information from their peers and mentors, from individual experience and from occasional seminars and conferences.
However over last two decades the practice of medicine has changed from the traditional mould to what is now popularly known as evidence-based medical practice. One of the most widely used definition of evidence-based medicine (EBM) is that by Sackett et al (2). They have defined it as ‘evidence-based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research’. Best external evidence would mean the most recent clinically relevant patient centred and basic sciences research (2). Previously accepted diagnostic tests and treatment modalities that have been invalidated by current research should be abandoned otherwise outdated practice can be detrimental to the patients. Opinion and experience-based practice in the past has proved to be ineffective and even harmful (3).
Often ‘clinicians are unaware of the available evidence or fail to apply it’ (4). Lack of time is the most frequent reason given by busy clinicians for their inability to keep abreast with current research. However ‘studies show that busy clinicians who devote their scarce reading time to selective, efficient, patient driven searching, appraisal, and incorporation of the best available evidence can practice evidence-based medicine’ (2). Treatment should do more good than harm to patients and the gold standard for such decision making would be systematic reviews of several randomised trials (2). Besides Medline there are many other online resources available for rapid access to the latest best evidence. For orthopaedic surgery, there are many well-researched resources available from where information can be rapidly obtained (5). The Cochrane reviews and structured abstracts in most journals provide very useful information which can help in evidence-based decision making. The Journal of Bone & Joint Surgery, for example, has structured abstracts and has a section on evidence-based orthopaedic besides the scientific articles.
For busy clinicians, well-researched evidence-based guidelines can be a source of valuation information. The U.S. Institute of Medicine defines clinical practice guidelines as ‘the consensus statements that have been systematically developed to assist practitioners and patients in making appropriate health care decisions for specific clinical circumstance’ (6).
Unfortunately, opinion based practice in orthopaedics is rampant with many traditions and myths which are not evidence based.
Myths in orthopaedic surgery
Husted et al has debunked many of the traditions and myths associated with hip and knee arthroplasty (7). Pre-operative removal of hair, urine sampling and testing, use of plastic adhesive drapes and preoperative warming of the operation theatre are not necessary and these measures do not improve the outcome of knee and hip arthroplasty yet these practices are almost universal. The intra-operative use of Tranemic acid is believed to be associated with increased risk of thromboembolic events which is not true. In fact, its use reduces bleeding and decreases the need for blood transfusion. The use of the tourniquet to improve cementing in knee replacement, use of disposable knives, routine use of indwelling urinary catheters and the use of drains to reduce haematoma formation in joint replacement has no scientific basis. Postoperative recommendations, of leaving the dressing untouched for 24 hours, avoidance of NSAIDS, avoiding flying in the early postoperative period, antibiotic prophylaxis for dental procedures, use of CPM, use of cryotherapy, not discharging patient till knee flexion is 90 degrees, and haemoglobin trigger of 10g/dl or a drop of haematocrit of 30% for blood transfusion, though widely practiced, these recommendations have no scientific basis.
When conservative medical treatment for knee pain, in patients with osteoarthritis, fails, surgeons generally advocate arthroscopic debridement of the knee. There has never been any physiological basis for such treatment and why it is done remains an enigma. In 2002 Moseley et al (8) published an article in the New England Journal of Medicine to show the futility of such treatment but to date such procedures are still carried out.
Arthroscopic partial meniscectomy is the most common orthopaedic operation performed in the USA (9). About 700,000 arthroscopic partial meniscectomies are performed annually in the USA at an estimated cost of 4 billion dollars (10). There is good scientific evidence that partial meniscectomy for degenerative tears provides no benefit to the patients (10) yet this practice is rampant.
When a patient presents to the physician with low back pain, an MRI of the lumbar spine is often the diagnostic test of choice of many physicians (often without any clinical work-up), despite the fact that abnormalities of the disc in asymptomatic people is well known. This idolatry of imaging is widespread and often the cause of back pain is attributed to the abnormalities detected by the MRI although the findings may be coincidental.
Jansen et al (11) studied the prevalence of MRI abnormalities of the lumbar spine in 98 asymptomatic subjects (50 men and 48 women) with an average age of 42.3 years. They found that only 38% of the subjects had a normal disc at all levels and 62% had abnormalities of the disc at one or more levels. Strong evidence shows that routine back imaging does not improve patient outcomes, exposes patients to unnecessary harms, and increases costs (12). Unnecessary imaging is done not only due financial incentives but also due to an unsubstantiated belief that imaging can be an alternative to a good history and physical examination.
Many physicians believe that osteoarthritis (OA) is a progressive degenerative disease of diarthrodial (synovial) joints characterised by pain, limitation of joint movements and eventually deformity of joints. However, there is scientific evidence to show that OA does not progress in all patients. Most of the studies of the natural history primary OA have been done for OA of the knee and studies for OA of the hip are sparse. The progression of knee OA is usually slow and it can take many years for the disease to progress. It is also known that it can remain stable for many years (13). In patients with osteophytes alone on radiographic examination, only one-third will show radiographic progression (14).
It is a common belief that OA is a progressive disease which would eventually lead to end stage disease which would require reconstructive surgery. Leyland et al in a 14 year population-based cohort study of 1,122 knees found that the percentage of knees with radiographic OA that were replaced (TKR) at year 15 was 1.1% for grade 0 knees, 4.9% for grade1 knees, 5.3% for grade 2 knees and 6.7% for grade 3 knees (15).
Spinal fusion for chronic non-specific back has no scientific basis yet such operations are frequently carried out. Chronic low back pain represents a common disabling and costly health problem but unfortunately in 80% to 95% of the patients a pathoanatomical diagnosis cannot be made despite the existence of modern imaging techniques (16). For spinal fusion to be successful in the treatment of chronic or recurrent low back pain there has to be a pathoanatomical diagnosis which accounts for the pain. The role of spinal fusion in progressive or unstable spondylolisthesis, spinal trauma, tumours and spinal infections is well established. However in patients with non-specific chronic low back pain a pathoanatomical diagnosis is often impossible to establish and, therefore, spinal fusion cannot be of any use in the treatment of chronic non-specific back pain.
There is a general belief that all ACL injuries must be treated with a reconstruction to minimise symptoms, improve the quality of life and minimise the risk of future complication such as chondral and meniscal injury. Now there is level 1 scientific evidence that the mid-term (5years) patient reported and radiographic outcomes between those patients treated with rehabilitation plus early ACL reconstruction and those treated with rehabilitation and optional delayed ACL reconstruction are the same in young active individuals (17). Another study by Neuman et al (18) which excluded professionals and those not willing to reduce their activity level and were followed up for 15 years the incidence of delayed reconstruction was 23%. This translates to a 77% of the patients who modify their activity level will not require an ACL reconstruction. Despite this evidence, there has been a dramatic increase in the number of anterior cruciate ligament (ACL) reconstructions that are carried out here in Malaysia as well as around the world.
Anecdotal evidence suggests that many surgeons recommend posterior cruciate ligament (PCL) reconstruction for injuries of the PCL. However, a review of the literature shows that reconstruction of the PCL is not the treatment of choice for PCL rupture. The majority of PCL tears produce a moderate laxity (10mm or less) of the PCL. The recommended treatment for such injuries is conservative with quadriceps muscle strengthening exercises. The treatment of choice of avulsion fractures involving the PCL when the fragment is large enough to be fixed with a screw is a surgical fixation of the fragment. The treatment of choice for chronic PCL tears is also conservative (19).
There are many surgeons who recommend a repair of grade 3 injuries of the lateral ligament of the ankle, but there is no evidence that such surgery gives better results than conservative treatment (20).
Myths continue to be perpetuated partly due to failure on the part of the physicians to keep abreast with current evidence-based medicine and also partly due financial conflicts of interest. Whatever the reasons why doctors continue to perpetuate these myths, failure to keep abreast with current evidence-based practice can have medicolegal implications.
Standard of care in medical negligence
There are 4 components in medical negligence claims which include a duty of care, breach of this duty and the breach caused (causation) injury (damage). It is a trite law that a duty of care is owed by the doctor to the patient. Breach of the standard of care is usually the threshold question in negligence claims. The question that usually arises is whether the physician possessed reasonable skill and exercised the skill in the care of the patient, which another reasonable physician would have exercised in a similar situation (21).
What a reasonable physician would have done under a given situation is decided by the court based on the testimony of the medical expert witness. The expert is expected to testify as to what others in the same profession would commonly do in such a situation. The expert normally refers to the clinical literature and research findings to support his/her testimony. Invariably the courts would expect the testimony to be supported with scientific evidence (21).
Determining what is a reasonable standard of care is a problem. Most of the experts will not know how the majority of the doctors practice medicine. They usually ‘rely on their personal experience or theoretical assumptions about what is reasonable or what they, as experts, would have done under the same circumstances’ (21). A reasonable standard of care can be determined by reference to current evidence-based literature which is easily available online rather than basing it on past experience and on what we have learnt from peers, mentors or from the occasional seminars and conferences. This would entail the need to stay abreast with current clinical and scientific literature.
Medicine and technology are rapidly evolving and it would be reasonable for the courts to expect that the standard of care evolves accordingly. Hence, there is a duty to stay abreast with current developments. In English law, there is an obligation on the part of the physician to make reasonable effort to stay abreast. Swanwick J in Stokes v Guest Keen & Nettlefold said that ‘where there is developing knowledge, [the defendant] must keep reasonably abreast of it and not be too slow to apply it’ (22). A medical practitioner cannot be expected to read every new article published in his field of speciality but in a situation where a particular risk has repeatedly been highlighted the physician will be ignoring it at his own risk (23). Though a practitioner cannot be expected to read every new article published, all practitioners have easy access to a wealth of concise information on evidence-based medicine and clinical practice guidelines on a vast range of topics.
Clinical guidelines and legal liability
Although science in medicine has made great strides in last few decades, yet much of what we practice remains unsupported by scientific evidence(3). Myths continue to be perpetuated because of our reluctance to embrace evidence-based practice. Our practice has been based largely on common sense, tradition and on information passed on by our mentors and peers. Evidence-based medicine is gaining momentum and hopefully it will reverse the past trends of customary medical practice. Evidence-based medicine distinguishes between the best relevant medical information from literature and what is known in legal terms as ‘junk science’ (24).
There is enormous information available in the scientific literature which is difficult for an average clinician to read and digest. To overcome this problem, clinical practice guidelines (CPGs) have been developed to aid clinicians in decision making. These guidelines are developed by multidisciplinary expert groups who systematically review all available data in the literature and reach a consensus as to what is the best way to approach a given clinical condition. The US Federal government in 1989 recognised the need for such guidelines and established the Agency for Health Care Policy and Research (AHCPR) which was later named as the Agency for Health Care Research and Quality (AHRQ). One of its functions is to do outcome research as well as to formulate and distribute clinical practice guidelines. AHRQ has a National Guideline Clearinghouse which makes publically available a database of thousands of evidence-based clinical practice guidelines and related documents and the contents are updated weekly (25).
Though many in the medical community have welcomed these guidelines as a valuable source of useful information, there are others who believe that these guidelines are an affront to professional autonomy and a challenge to clinical judgement (26). Despite the criticism by some that these guidelines is ‘cookbook medicine’, the emphasis on EBM and formulation of CPGs is gaining momentum.
CPGs are not a substitute for EBM but is an important component of EBM, the aim of both is to assist physicians in making clinical decisions. Some CPGs may not be updated regularly hence the need to remain abreast with EBM is vital.
Though in the USA and UK clinical guidelines are not applied in courts as a legal standard of care, in the Netherlands published guidelines for general practitioners are accepted by the court as a legal standard of care. In France, legislations are in place to make practice by the guidelines mandatory, and there are sanctions for practitioners who deviate from such practice (24).
In the USA and the UK, guidelines cannot be admitted as evidence of the standard of care because such evidence would be regarded as hearsay. However, the expert witness in his testimony can use the guidelines as evidence of the standard of care. The use of guidelines by an expert in his testimony could fulfil the requirements of the standards set in Bolam (27) as well as those in Bolitho (28). Clinical guidelines are prepared by multidisciplinary expert groups who systematically review all available data in the literature and reach a consensus hence the guidelines would conform to Bolam’s requirement of a similar body of responsible and skilled professionals. Without a doubt the guidelines weigh all benefits and risk and are logical conclusions arrived at by experts, hence they would fulfil the requirements of Bolitho.
Many legal academics believe that with the growing emphasis on EBM and CPGs, the CPGs will in future ‘define the requisite "standard of care" for medical treatment and impact medical malpractice litigation. They may even replace expert testimony’ (24).
Repair of ligaments, joint debridement for OA, spinal fusion for non-specific back and neck pain are by far the most common elective orthopaedic procedures performed by orthopaedic surgeons. The traditional orthopaedic practice of routine repair of ligaments, spinal fusion for non-specific back and neck pain, joint debridement for OA, and sometimes joint replacement for joint pain in the absence of moderate to severe osteoarthritis, is unlikely to fulfil the requirements which the courts will expect in the standard of care analysis.
Conclusion
There is no doubt that there has been a steep rise in the malpractice insurance premiums for orthopaedic surgery over last two decades and the premiums continue to rise every year. This is a reflection of the increase in the number of malpractice suits filed in the courts as well as a reflection of the number of successful claims with high payouts in recent years. The customary orthopaedic practice of yesteryears cannot continue and we have to embrace rapidly evolving evidence-based practice. Lack of time cannot be an excuse since valuable evidence-based information is easily available.
Evidence base medicine is making inroads in the standard of care analysis by the courts to assess whether the surgeon exercised reasonable care and skill in diagnosing, advising and treating the patient. If we continue to practice opinion based medicine and not embrace evidence based medicine we will be at risk of being a subject of a malpractice suit.
References
1. Grubb A, Laing J and McHale J eds. Principles of medical law. (3rd ed. Oxford University press, 2010).
2. Sackett DL, Rosenberg MC, Gray JAM, Haynes RB and Richardson WS. Evidence based medicine: what it is and what it isn't. BMJ 1996; 312:71-72.
3. Leape L, Berwick D, Bates D. What practices will most improve safety? Evidence-based medicine meets patient safety. JAMA 2002; 288(40): 501-507.
4. Guyatt G, Cook D, Haynes B. Evidence based medicine has come a long way; the second decade will be as exciting as the first. BMJ. 2004 Oct 30; 329(7473): 990–991.
5. Field MJ & Lohr KN eds., Guidelines for Clinical Practice: From Development to Use, 27 INST. OF MED (1992); BARRY R. FURROW ET AL., HEALTH LAW: CASES, MATERIALS AND PROBLEMS 179 (6th ed. 2008). (Defining ‘guidelines’ further as “standardized specifications for using a procedure or managing a particular clinical problem”).
6. Treatment of osteoarthritis of the knee. Evidence-based guideline; second edition 2013 at http://www.aaos.org/research/guidelines/treatmentofOsteoarthritisoftheKneeGuideline.pdf.
Evidence-based management of acute musculoskeletal pain. Australian Acute Musculoskeletal Pain Guidelines Group. June 2003 at http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/cp94.pdf
Airaksinen O, Brox JI, Cedraschi C et al. European Guidelines for the Management of Chronic Non-specific Low Back Pain. Eur Spine J. 2006; 15 (Suppl. 2): S192–S300. DOI 10.1007/s00586-006-1072-1.
7. Husted H, Gromov K, Malchau H, Freiberg A, Gebuhr P, Troelsen A, et al. Mythbusting in Orthopedics: Traditions and myths in hip and knee arthroplasty: A narrative review. Acta Orthopaedica. 2014; Vol. 85, No. 6: 548-555.
8. Moseley JB, O’Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, et al
A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med 2002; 347:81-88.
9. Cullen KA, Hall MJ, Golosinskiy A. Ambulatory surgery in the United States, 2006. Natl Health Stat Rep 2009;11:1-25.
10. Sihvonen R, Paavola M, Malmivaara A, Itälä A, Joukainen A, Nurmi H, et al. Finnish Degenerative Meniscal Lesion Study (FIDELITY) Group. Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear. N Engl J Med. 2013; 369(26):2515-24.
11. Jensen MC, Brant-Zawadzki MN, Obuchowski N, Modic MT, Malkasian D, and Ross JS. Magnetic Resonance Imaging of the Lumbar Spine in People without Back Pain. N Engl J Med. 1994; 331(2):69-73.
12. Chou R, Deyo RA, Jarvik JG. Appropriate Use of Lumbar Imaging for Evaluation of Low Back Pain. Radiol Clin N Am. 2012; 50: 569–585.
13. Dieppe P. Developments in osteoarthritis. Rheumatology 2011; 50: 245.
14. Danielsson L, Hernborg J. Clinical and roentgenologic study of knee joints with osteophytes. Clin Orthop Rel Res. 1970; 69:224-6.
15. Leyland KM, Hart DJ, Javaid MK, Judge A, Kiran A, Soni A, et al. The natural history of radiographic knee osteoarthritis: A fourteen-year population-based cohort study. Arthritis & Rheumatism. 2012; 64(7): 2243-2251.
16. Waddell G. Subgroups within "nonspecific" low back pain. J Rheumatol 2005; 32; 395-396.
17. Frobell R, Roos H, Roos E, Roemar F, Ranstam J, Lohmander L. Treatment for anterior cruciate ligament tear: five year outcome of randomized trial. BMJ 2013; 346: 232.
18. Neuman P, Englund M, Kistogiannis J, Friden T, Ross H, Dahlberg LE. Prevalence of tibio-femoral osteoarthritis 15 years after nonoperative treatment of anterior cruciate ligament injury: A prospective cohort study. Am J Sports Med 2008; 36(9):1717-1725.
19. Veltri DM, Warren RF. Isolated and Combined Posterior Cruciate Ligament Injuries. J Am Acad Orthop Surg 1993; 1:67-75.
20. Pihlajamaki H, Hietaniemi K, Paavola M, Visuri T, Mattila VM. Surgical versus functional treatment of the lateral ligament complex of the ankle in young men: A randomised controlled trial. J Bone Joint Surg AM. 2010; 92:1-8.
21. ChingPing Lin, Evidence-Based Guidelines and Their Influence on the Standard of Care (May 2011). http://nrs.harvard.edu/urn-3:HUL.InstRepos:8965633.
22. Stokes v Guest, Keen & Nettlefold (Bolts & Nuts Ltd [1968] 1 WLR 1776, 1783.
23. Roe v Minister of health [1954] 2 QB 66.
24. Davies J. Clinical guidelines as a tool for legal liability. An international perspective. Med Law. 2009 Dec; 28(4):603-13.
25. Agency for Healthcare Research and Quality, U.S. Department of Health & Human Service. http://www.ahrq.gov/professionals/clinicians-providers/guidelines-recommendations/index.html.
26. Williams CL. Evidence-Based Medicine in the Law Beyond Clinical Practice Guidelines: What Effect Will EBM Have on the Standard of Care? Wash. & Lee L. Rev. 2004; 61:479.
27. Bolam v Friern Hospital Management Committee [1957] 1 WLR 582.
28. Bolitho v City and Hackney Health Authority [1997] 4 All ER 771.
