Management of meniscal injuries of the knee

                       Management of meniscal injuries of the knee

                                              Dr KS Dhillon FRCS

Introduction

The role played by the menisci in function of the knee has been well established. It is important to preserve the meniscus whenever possible. Degenerative tears of the meniscus are common and can be present in asymptomatic individual. Arthroscopic partial meniscectomy is and has been one of the most common orthopaedic surgical procedure in most countries around the world. However, there is now good evidence available to show that arthroscopic partial meniscectomy does not benefit most patients with meniscal tears. This article reviews the recent literature and attempts to settles some of the controversies associated with the management of meniscal injuries of the knee.

Anatomy of the meniscus

The are two menisci in the knee, namely the medial and lateral meniscus. The medial meniscus is C-shaped with a triangular cross section. The average width is about 9 to 10 mm and the average thickness is about 3 to 5 mm. The lateral meniscus is almost circular in shape and it covers a large portion of the articular cartilage. Its average width is 10 to 12 mm and its average thickness is about 4 to 5 mm.
The menisci are composed of fibroelastic cartilage. The fibroelastic cartilage is made of an interlacing network of collagen, proteoglycan, glycoproteins, cellular elements and 65-75% water. Ninety percent of the collagen is type I collagen. There are two types of fibres, the longitudinal
(circumferential) and the radial fibres, which allow the meniscus to expand under compressive load, expand the contact area and reduce stresses across the the joint.
The medial inferior genicular artery supplies the peripheral 20-30% of medial meniscus and the lateral inferior genicular artery supplies peripheral 10-25% of lateral meniscus. The central 75% of both menisci receive nutrition through diffusion.

Classification of meniscus tears

A.Descriptive classification of meniscal tear by location

Meniscal tears can occur in the red zone (outer third, vascularized), in the
red-white zone (middle third) or in the white zone (inner third, avascular).

 B.Descriptive classification of meniscal tear by pattern of tear

Meniscal tears can be classified into three types based on the pattern of tear [1]:

1.Basic tears
   A.Longitudinally oriented tears
       i.Horizontal tears (cleavage tears)--These tears are parallel to the    tibial plateau involving one of the articular surfaces or free edge and they divide the meniscus into superior and inferior parts.
        ii. longitudinal tear (vertical tear)--The tear is perpendicular to the tibial plateau and parallel to the long axis of the meniscus. It divides the
divides the meniscus into medial and lateral parts. A Wrisberg rip is a specific subtype, longitudinal tear in the posterior horn of the lateral meniscus that extends laterally from the Wrisberg ligament attachment.
  B.Radial tears -- These tears are perpendicular to both the tibial plateau and the long axis of the meniscus.
  C.Root tears: These tears are typically radial-type tear located at the root of the meniscus.

2.Complex tears
These tears are a combination of all or some of the horizontal, longitudinal and radial-type tears.

3.Displaced tears
Displaced tears are those in which the torn portion of the meniscus is displaced and it can still be attached to the  parent meniscus or detached. There are 3 subtype of displaced tears.
Flap tear: displaced horizontal or longitudinal tears
Bucket-handle tear: displaced longitudinal tear
Parrot beak tear: displaced radial tear

Radiological diagnosis

An MRI has a sensitivity of about 95% and a specificity of 81% for medial meniscal tears and a sensitivity of about 85% and a specificity of 93% for lateral meniscal tears [2]. An MRI of the knee is the modality of choice for investigating a suspected tear of the meniscus and sagittal images are  most useful [3]. A MRI of the knee has an overall 88% sensitivity and 94% specificity for detecting meniscal lesions [4].
There are three MRI criteria for diagnosis of meniscal tears [3]:
A high intrameniscal signal extending to at least one articular surface
The high intrameniscal signal should be seen in at least two slices  (two slice touch rule).
Distortion of the normal meniscal morphology if there has been no prior surgery.
In the T1 sequence a hyperintense line in the meniscus can be due to a tear or due to degeneration. When there is a bucket handle tear an empty groove may be seen.
In the T2 sequence the hyperintense line in the meniscus which indicates synovial fluid in the meniscus may be due to degeneration and not a tear in an adult and due to high vascularity in children [5].
MRI grading system for meniscal signal intensity [6].
The MRI abnormal high meniscal signal intensity can be graded into three:
Grade 1: There is a small focal area of hyperintensity with no extension to the articular surface
Grade 2: There is a linear area of hyperintensity with no extension to the articular surface
2a: There is a linear abnormal hyperintensity with no extension to the articular surface
2b: There is an abnormal hyperintensity which reaches the articular surface on only one single image
2c: There is a globular wedge-shaped abnormal hyperintensity with no extension to the articular surface
Half of the patients with grade 2c abnormal meniscal signals have been found to have meniscal tears on arthroscopy [7]
Grade 3: There is abnormal hyperintensity which extends to at least one articular surface (superior or inferior) which is indicative of a definite tear of the meniscus

A grade 3 MRI signal is indicative of a tear of the meniscus and a "double anterior horn" sign and a "double PCL"  sign are both indicative of a bucket handle tear of the meniscus.

Prevalence of meniscal abnormalities on MRI of the knee

Zanetti et al (8] studied 100 patients with suspected meniscal tears, who had one symptomatic knee and the other asymptomatic knee, with an MRI of the knee to evaluate the prevalence of meniscal abnormalities in the knee. The mean age of these 100 patients was 42.7 years with a range between 18 to 73 years.
They found meniscal tears in 57 symptomatic knees (57%) and in 36 contralateral asymptomatic knees (36%). In the 57 patients who had a tear of the meniscus on the symptomatic side, 63% of these patients had a tear in the contralateral asymptomatic side. In other words, if there is a tear of the meniscus on the symptomatic side, there is a 63% chance that there will be a tear on the opposite asymptomatic side.
Radial, vertical, complex, or displaced meniscal tears and abnormalities of the collateral ligaments, pericapsular soft tissues, and bone marrow abnormalities were mostly seen in symptomatic knees and these findings appear to be clinical significant. Horizontal or oblique meniscal tears on the other hand were frequently seen in both asymptomatic and symptomatic knees and these findings may not often be related to symptoms [8].
Englund et al [9] studied the prevalence of meniscal damage in the general population and the association of meniscal tears with knee symptoms and with radiographic evidence of osteoarthritis. They found that the prevalence of a meniscal tear or of meniscal damage in the right knee as seen on a MRI ranged from 19% (range 15 to 24), among women 50 to 59 years of age, to 56% (range 46 to 66) among men 70 to 90 years of age. Among individuals with radiographic evidence of osteoarthritis (Kellgren–Lawrence grade 2 or higher) the prevalence of a meniscal tear was 63% among those with knee symptoms on most days and 60% among those without symptoms. The corresponding prevalence of meniscal tears among persons without radiographic osteoarthritis were 32% and 23%. Sixty-one percent of the individuals who had meniscal tears in their knees had no symptoms during the previous month.
The authors concluded that incidental findings of meniscal abnormalities on MRI of the knee are common in the general population and increases with age, irrespective of knee symptoms, and often accompanies knee osteoarthritis. Hence clinicians who order MRI of the knee should keep in mind the high prevalence of incidental tears when interpreting the MRI and  planning therapy.
Other authors have reported a high prevalence of meniscal damage ranging from 67 to 91% in patients with symptomatic osteoarthritis of the knee [10,11,12,13].
In the study by Bhattacharyya et al [13], which involved U.S. veterans,  most of whom were men, meniscal tears were noted in 75.5% control subjects who had no knee pain (mean age, 67 years) and had sought medical care for other conditions. They also found that knees with meniscal tear were not more painful than those without a tear and that meniscal tears do not affect functional status in patients with knee OA.
Other studies have also showed that a meniscal tear of the knee is common in individuals who had no symptoms of the knee [14,15,16,17,18].

Treatment of meniscal tears

There are three treatment options for patients with symptomatic tears of the meniscus. These include non-operative treatment, meniscectomy and meniscal repair. Selecting appropriate treatment can often be difficult and will depend on the patient characteristics such as age, co-morbidities and tear characteristics such as the type, location and size of tear.
Non-operative treatment of meniscal tears
There is level I irrefutable evidence that patients with osteoarthritis of the knee with meniscal tears do not benefit from arthroscopic debridement of the joint. Hence the treatment of choice for degenerative meniscus tears is non-surgical.
Moseley et al (19) did a randomised, placebo-controlled trial to assess the efficacy of arthroscopic knee surgery to relieve knee pain and improve function in patients with OA of the knee. They had three groups of patients who either had, joint lavage, joint debridement or sham incisions at the arthroscopic portals. Their study showed strong evidence that arthroscopic lavage with or without debridement is no better than placebo in relieving pain and improving self-reported knee function.
Kirkley et al (20) in 2008 published the outcome of a single-center, randomized, controlled trial of arthroscopic surgery in patients with moderate-to-severe osteoarthritis of the knee. They randomly assigned patients to arthroscopic joint debridement with surgical lavage and  physical plus  medical therapy or to treatment with physical and medical therapy alone. At 2 years follow up they found that arthroscopic surgery for osteoarthritis of the knee provided  no additional benefit as compared to optimized physical and medical therapy.
Sihvonen et al (21) did a multicenter, randomized, double-blind, sham-controlled trial to assess the efficacy of arthroscopic partial meniscectomy in patients who had a degenerative tear of the medial meniscus without knee osteoarthritis. Patients with obvious traumatic onset of symptoms and those with OA were excluded. The study showed that arthroscopic partial meniscectomy was not superior to sham surgery, with regard to pain and functional knee scores assessed during a 12-month follow-up period. The authors concluded that partial meniscectomy for degenerative tears provides no benefit to the patients and that there is no scientific basis for continuing the current practice of doing partial meniscectomy for degenerative tears of the meniscus.
Thorlund et al [22] did a comparative prospective cohort study, to compare patient reported outcomes, of arthroscopic partial meniscectomy in patients with traumatic meniscal tears as compared to that in patients with degenerative meniscal tears, at 52 weeks follow up.
They studied four of five subscales of the knee injury and osteoarthritis outcome score (KOOS) which covered pain, symptoms, sport and recreational function, and quality of life (KOOS4). Their study showed
better self-reported outcomes in patients with degenerative tears as compared to patients with traumatic tears but the difference between the two groups ‘was at no time point considered clinically meaningful’ [22].
The authors questioned the ‘current tenet that patients with traumatic meniscal tears experience greater improvements in patient reported outcomes after arthroscopic partial meniscectomy than patients with degenerative tears’ [22].
So far there have been no randomised controlled trials comparing the outcome of arthroscopic partial meniscectomy with sham surgery or non-surgical treatment for traumatic meniscal tears [23].
Sihvonen et al’s  study (21) provides level I evidence that arthroscopic partial meniscectomy in patients with degenerative tear of the meniscus provides no benefit to the patient when compared with a sham operation. Thorlund et al’s [22] comparative prospective cohort study shows that the outcome of arthroscopic partial meniscectomy in patients with traumatic meniscal tears is no better than that of partial meniscectomy in patients with degenerative tear of the meniscus. This would mean that arthroscopic partial meniscectomy has no role to play in the treatment of partial tears of the meniscus.
Non-operative treatments such as exercise and quadricep strengthening improves knee function and reduces knee pain [24,25,26]. Pain and swelling associated with meniscal tears can be treated non-steroidal medications.
There is definitely no role for surgery in the treatment of degenerative tears of the meniscus. The outcome of partial meniscectomy for traumatic tears of the meniscus is not better than that of partial meniscectomy for degenerative tears as has been believed in the past.

Surgical treatment of traumatic tears of the meniscus

The role played by the menisci in function of the knee has been well established. The main function includes load bearing, shock absorption, stabilisation, joint lubrication, nutrition of the articular cartilage and proprioception [27]. Hence in the management of patients with traumatic meniscal tears all attempts to preserve the meniscus are made.
Pain and mechanical symptoms such as clicking, catching, locking, pinching, or a sensation of giving way associated with unstable meniscal fragment may need surgical intervention.
Unstable meniscal fragments not amenable to repair have to be excised by arthroscopic partial meniscectomy. Tears in the red-red zone, where there is blood supply, can be repaired because there is potential for healing. Some in the red-white zone can heal when repaired. Tears in the rest of the meniscus which is avascular, cannot be repaired, are subjected to a meniscectomy.
Studies comparing the outcome of meniscal repair with meniscectomy are limited. It is difficult to postoperatively define a healed meniscus because postoperative MRIs are not very accurate in defining a successful repair. High signal seen on an MRI may represent oedema, degeneration of the meniscus, an actual tear or postoperative healing and scar [28]. The most accurate way to access a successful repair would be a second look arthroscopy but there can be ethical concerns when second-look arthroscopies are performed to evaluate the success of a meniscal repair. Randomising patients to receive a repair or a meniscectomy can also lead to ethical concern[29].
Seo et al [30] did a second look arthroscopy in 11 patients (who were available for review) out of 21 consecutive patients who underwent arthroscopic pullout suture repair for a posterior root tear of the medial meniscus, at an average of 13.4 months (range 10 to 22 months) follow up. In this case series (level 4 evidence), they found that in none of the patients a complete healing had occurred.
In 5 knees there was lax healing, 2 of which were symptomatic and three asymptomatic. In 4 knees there was scar tissue healing and all 4 were asymptomatic. In  2 knees there was no healing and of the 2, one was symptomatic and one asymptomatic. There was progression of the chondral lesion in one case. The mean Lysholm scores improved from 56.1 preoperatively to 83.0 at follow-up and the mean Hospital for Special Surgery score also significantly increased, from 64.1 to 87.4.
Despite the lack of complete healing in all patients,why there was significant clinical improvement remains unexplained.
Cho et al [31] retrospectively reviewed 13 of 20 consecutive patients who underwent arthroscopic modified pull-out suture repair for a posterior root tear of the medial meniscus. The 13 were available for a second-look arthroscopic evaluation. In 4 cases there was complete healing , in 4 lax healing, in 4 scar tissue healing and in 1 there was no healing. Seven of the 13 patients were asymptomatic. The mean Lysholm scores increased from 34.7 points before the repair to 75.6 points at the second-look arthroscopy and the HSS scores increased from 33.5 to 82. Functional outcome was good in these patients despite incomplete healing of the repair.
Pujol et al [32] evaluated healing of the meniscus after a repair using arthro-CT scans. At 6 months post repair of the meniscus an arthro-CT scan showed complete healing in 58% of the patients, partial healing in 24% and failed healing in 18% of the patients. They also found that the healing in posterior segment tears was lower than that in middle portion tears. Despite the the lack of complete healing in almost half of the patients, the clinical outcome was good in most of the patients.
Paxton et al [33] did a systematic literature review to compare reoperation rates and clinical outcomes after meniscal repair and partial meniscectomy in patients with traumatic meniscal tears. At short and long term follow up partial meniscectomy had lower reoperation rates. The short and long term reoperation rates for partial meniscectomy were 1.4% and 3.9% respectively whereas for meniscal repair were 16.5% and 20.7% respectively. There were a limited number of studies with long term clinical outcome and these small number of studies reported that a meniscal repair was associated with higher Lysholm scores and less radiologic degeneration than partial meniscectomy.
Noyes and Barber-Westin [34] did a systematic review of the literature in 2012 to find out the incidence of meniscectomy, meniscus repair, and tears left in situ during ACL reconstruction in the previous 10 years. In the 159 studies analysed, there were 11,711 meniscal tears. Sixty-five percent of the tears were treated by meniscectomy, 26% of the tears were repaired and 9% were left in situ without any treatment. The incidence of meniscal repair was 26% in patients undergoing ACL reconstruction.
Mutsaerts et al [35] in 2016 did a literature review of all randomized controlled clinical trials which compared various surgical techniques for the treatment of meniscal injuries including; total and partial meniscectomy; meniscectomy and meniscal repair; meniscectomy and meniscal transplantation; open and arthroscopic meniscectomy and various different repair techniques.
This Level I meta-analysis showed that there is a lack of level I evidence to guide the surgical management of meniscal tears.
Degenerative tears of the meniscus do not need any surgery and most traumatic tears of the meniscus also do not need surgery. Patients with traumatic tears who have mechanical symptoms may need surgery. Tears in the avascular region would need a partial meniscectomy. Whether to do a meniscal repair or not remains unclear since there is a lack of level I evidence to guide treatment options. There have been case reports where spontaneous healing of bucket handle tears of the meniscus have occurred, when patients have opted for non-operative treatment or surgery has been delayed for some reason [35,36,37]. Furthermore, definitely there are patients who sustain meniscal injuries and never seek treatment, where spontaneous healing occurs.

Complications of arthroscopic surgery

The overall complications for knee arthroscopy are about 8.2% [38]. Sherman et al [38] retrospectively reviewed 2640 arthroscopic procedures and found an 8.2% incidence of complications,of which 4.8% were major and 3.6% minor complications.The major complications included infections, hemarthrosis, adhesions, effusions, cardiovascular, neurological, reflex sympathetic dystrophy, and instrument breakage, and the minor complications included problems with wound-healing and ecchymosis. Diagnostic arthroscopy had the lowest complication rate and partial medial meniscectomy was associated with a higher complication rate and highest hemarthrosis rate, while partial lateral meniscectomy was associated with the highest rate of instrument breakages. Age more than 50 years and a tourniquet time of more than 60 minutes were risk factors for complications. Surgeon experience had no influence on the complication rates [38].
Salzler et al [39] found a 2.8% complication rate for meniscectomy and a 7.6% complication rate for meniscal repair. They found that the complication rates were higher with sports fellowship-trained surgeons as compared to those who had no sports fellowship training.
Austin and Sherman [40] in a study involving 101 consecutive arthroscopic meniscal repairs found an overall complication rate of 18%. In patient with anterior cruciate tears the meniscus repair was associated with a 20% risk of complication and in those without anterior cruciate injury the complication rate was 14%. The incidence of arthrofibrosis was 10% when there was an ACL tear and 6% when there was no ACL tear in patients undergoing meniscal repair. The overall risk of complications was 19% with medial meniscus repair and 13% with lateral meniscus repairs. The reoperation or rehospitalization rate (excluding repair failures) was 8%.

Infection
Septic knee arthritis following simple arthroscopy procedures is uncommon but it is dreaded complication. The incidence of septic arthritis following simple arthroscopic procedures ranges from 0.009% to 1.1% [41].
In this study the most common pathogen causing infection was Staphylococcus , both coagulase positive and negative. Other bacterias implicated included Enterobacter cloacae, Streptococcus spp. and Serratia marcescens [41].
Risk factors for septic arthritis include age more than 50 years, tourniquet time more than 60 min, longer duration of surgery, male sex, diabetes, morbid obesity, tobacco use, use of intra-articular steroids and complex procedures [41].

Thromboembolic complications
Venographic incidence of deep-vein thrombosis (DVT) after arthroscopy can be up to 17.9% [42]. Most of these are distal and of not much clinical significance.
The incidence of symptomatic and proximal thromboembolic disease,
which can progress to pulmonary embolism (PE), is less than 1% in patients undergoing knee arthroscopy [43-47]. Routine thromboprophylaxis is not recommended for patients undergoing arthroscopy unless certain risk factors such as older age, history of cancer, complexity of surgery, female sex, longer duration of surgery, history of previous DVT, obesity, immobility, varicose veins and use of oral contraceptives, are present [48,49]. A postoperative high index of suspicion is essential in patients where these risk factors are present.

Vascular complications
The Committee on Complications of the Arthroscopy Association of North
America, reported 12 vascular injuries (0.0032 %) in 375,069 knee arthroscopies carried out in North America. Out of these 12 cases of vascular injury reported, 4 required an amputation [50]. DeLee [51], in the
AANA review of complication of arthroscopy in the US, reported six cases of penetrating injury to the popliteal artery (0.005%) in 118,590 arthroscopic procedures. In 4 of these 6 patients an amputation was required.
Although the incidence of vascular injury is low in patients undergoing arthroscopy, a high index of suspicion is necessary and a prompt diagnosis, and early surgical intervention is essential to prevent a risk of loss of limb or life.

Neurological injury
Rodeo et al [52] reported that there are 4 mechanisms by which nerve injury can occur during arthroscopy.These include, direct trauma, pressure
secondary to a compartment syndrome occurring as a result of extravasation of fluid, damage related to the use of a tourniquet and due to reflex sympathetic dystrophy. The reported incidence of neurological injury following knee arthroscopy ranges between 0.01 to 0.6 percent [51]. The nerves that can be injured include the saphenous, tibial and peroneal nerves. The most commonly injured nerve is the saphenous nerve followed by the peroneal nerve. Neurological complications are more often seen with meniscus repairs.

Conclusions

A clinical diagnosis of meniscus tear should be made when a patients complains of knee pain following trauma to the knee. A history of mechanical symptoms of catching, click and giving way would suggest the presence of an unstable meniscus tear which would require treatment. All other tears of the meniscus do not need treatment and hence there is no need for radiological investigations. When clinical diagnosis of an unstable tear of the meniscus which requires surgery is made, an MRI of the knee would be a useful investigation. There is no role of arthroscopic meniscectomy in the treatment of degenerative and traumatic tears when the tear is stable.
There is, however, a lack of Level I evidence to guide the surgical management of traumatic meniscal tears. Studies comparing the outcome of meniscal repair with meniscectomy are limited and of not good quality. Arthroscopy and meniscal surgery can be associated serious complication although the incidence of serious complications is low.




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42. Demers C, Marcoux S, Ginsberg JS, et al. Incidence of venographically proved deep vein thrombosis after knee arthroscopy. Arch Intern Med 1998;158:47-50.
43. Dahl OE, Gudmundsen TE, Haukeland L. Late occurring clinical deep vein thrombosis in joint-operated patients. Acta Orthop Scand 2000;71:47-50.
44. Geerts WH, Bergqvist D, Pineo GF, et al; American College of Chest Physicians. Prevention of venous thromboembolism: American College of Chest Physicians evidence-based clinical practice guidelines (8th Edition). Chest 2008;133(Suppl):381-453.
45. Jaureguito JW, Greenwald AE, Wilcox JF, Paulos LE, Rosenberg TD. The incidence of deep venous thrombosis after arthroscopic knee surgery. Am J Sports Med 1999;27:707-10.
46. Ramos J, Perrotta C, Badariotti G, Berenstein G. Interventions for preventing venous thromboembolism in adults undergoing knee arthroscopy. Cochrane Database Syst Rev 2008;4:CD005259.
47. Sherman OH, Fox JM, Snyder SJ, et al. Arthroscopy: “no problem surgery”: an analysis of complications in two thousand six hundred and forty cases. J Bone Joint Surg [Am] 1986;68-A:256-65.
48. Hetsroni I. Lyman S, Do H, Mann G and Marx RG. Symptomatic pulmonary embolism after outpatient arthroscopic procedures of the Knee: The incidence and risk factors in 418,322 arthroscopies. J Bone Joint Surg [Br] 2011;93-B:47-51.
49. Anderson FA and Spencer FA. Risk Factors for Venous Thromboembolism. Circulation. 2003;107:I-9–I-16.
50. Small NC. Complications in arthroscopy: the knee and other joints, Committee on Complications of the Arthroscopy Association of North America. Arthroscopy 1986;2:253-8.
51. DeLee JC. Chairman, Committee on Complications of Arthroscopy Association of North America. Complications of arthroscopy and arthroscopic surgery: results of a national survey. J Arthroscopic Rel Surg 1985;1:214-20.
52. Rodeo SA, Sobel M, Weiland AJ. Deep peroneal-nerve injury as a result of arthroscopic meniscectomy: a case report and review of the literature. J Bone Joint Surg [Am] 1993;75-A:1221-4.

Legal Issues Surrounding Electronic Medical Records

                 Legal Issues Surrounding Electronic Medical Records

                                                  Dr KS Dhillon LLM

What is electronic medical record (EMR)?

Traditionally medical records have been paper based. The hospitals have been collecting handwritten patient medical data and storing it securely as per the legal requirement of handling and storing patients confidential medical data.
Over the last couple of decades there has been a push to record, process, store and transfer health information electronically. This electronically recorded, processed and stored medical data is known as electronic medical records (EMRs). The electronic application not only helps in recording clinical data, X-rays and laboratory findings but also helps in making decisions, making request for medication from the pharmacy and placing and receiving orders regarding patient care [1]. The EMR system would require the use of a computer system with the necessary software along with a network.
The touted benefits of the EMR include improvement in quality of patient care, decrease in health care costs, reduction in storage space requirements and easy of searching the patients records. Electronic data can be more easily retrieved and modified and updated thereby increasing efficiency. By using appropriate templates the doctors can safe time and make less mistakes [1].
Some believe that these electronic systems which are faster than the paper system can save time, lives, and money [1].
Despite the touted benefits of the EMR the transition from paper to electronic recording has been very slow. In the USA the Healthcare Information and Management Systems Society (HIMSS) has planned the implementation and use of the EMR system in 7 stages. As of 2013 EMR implementation was in stage 2 and stage 3. In stage 6, about 100 % of the hospitals were expected to be covered. Stage 7, would see the building of the regional and national network that would integrate all the EMR systems in the country [1]. In the US as of 2013 only 25.5% of the hospitals had a comprehensive EMR.
In Malaysia, the Ministry of Health, in 2001 claimed that Hospital Selayang was the first hospital in the world to have a comprehensive ICT paperless system using the Total Hospital Information System (THIS)[2].
The capital cost of equipping a hospital with THIS is about 80 to 100 million ringgit in Malaysia and this constitutes almost 40% of the total development cost of a 800-1000 beds hospital. So far the Malaysian government has spent more than 600 million Ringgit for the project and this does not
include operation and maintenance cost of the system [2]. As of 2015 only 21 out of 138 public hospitals (15%) had implemented either the Total Hospital Information System (THIS), the Intermediate Hospital Information System (IHIS) or Basic Hospital Information System (BHIS).
Though firewalls and encryption do permit safer and secure transfer of health information, confidentiality of patient information and other legal risks remains a concern.

Legal Risks of EMRs

The legal system relies on precedent and is slow to adopt new technologies such as EMRs. Hence it can offer little help in the navigation from paper-based to electronic record [3]. Though EMRs may be able to solve problems of missing clinical information that was seen with paper records, there is no legal precedent addressing the responsibility of clinicians reviewing the large amount of clinical information available in the integrated EMRS. Many find it difficult to review the complete electronic record within a reasonable timeframe [3].
Furthermore EMRs introduce several more liabilities. Large amounts of perfectly legible data can be stored in EMRs which makes it easily discoverable, unlike incomplete or illegible handwritten records which are not easily discoverable. Hence the EMR data can be a liability to the doctor and the health provider.
EMRs can store extremely huge amount of data which can lead to information overload resulting in the doctor overlooking key information in the system. This again can be a new form of liability. In this mountain of information, doctors can miss critical information which can affect treatment decision which would make doctors and the hospital liable for negligence [3].
With EMRs the doctors legal responsibility and accountability increases. The electronic records will identify the person who reviewed or failed to review key information such abnormal findings recorded in the EMR. Failure to identify and address important abnormal findings can lead to legal challenges. With paper records it is not always possible to tell who accessed the records. Lapses in management of the patient can easily be detected with EMRs[3].
There are some document related issues with EMRs which can introduce new liabilities. Some EMRs contain progress note documentation templates which allow test results to be automatically imported. This automatically imported test and clinical findings may not be within the clinical preview of the the person inadvertently importing the information and signing the note electronically and this may introduce new liabilities [3]. Notes that are copied and pasted may contain lots of information that appear similar and display information that is no longer correct.

Ethical issues with EMRs

Data in EMRs can more easily be accessed by many individuals as compared to data in paper records. Data in paper records can also be accessed by others but it is difficult to track who accessed the paper records. Since more people have access to electronic data the potential for privacy breach increases. When many people have access to electronic data the question of ownership of data also arises. Who actually owns this protected health information?[3]
In the past ‘several electronic health records (EHR) vendors (eg, Cerner, GE, and Allscripts [formerly Eclipsys]) have sold deidentified copies of their patient databases to pharmaceutical companies, medical device makers, and health services researchers’ [3]. Although the data is deidentified, it is not difficult to reidentified the data using publically available external data sources[3].
There are EHR user guidelines but what happens when unauthorized personnel access the the data and also what happens when unintentional or unavoidable violation of the guidelines take place? An example would be when a person who is logged in has to rush off for an emergency and someone standing by accesses the data. These situations raise complex ethical and legal issues[3].
This electronic data-driven approach in medicine has a long way to go. There are many unaddressed issues to be sorted out. Who will ‘oversee the data aggregation, verification and validation, and analysis; who will have data access; who will make the final data interpretations; and assuming that everyone agrees they are correct, who will adjudicate the ethical disagreements that inevitably surface when data are used to inform new health care policies’ [3]. There is a dire need for ‘nonpartisan, multidisciplinary, expert review-panels composed of clinicians, statisticians, informaticians, ethicists, and patient advocates’ to sit together and address these issues rather than pushing half baked electronic systems done the throat of unwilling users.
The goal of providing higher quality, lower-cost health care through widespread EHR remains elusive.

Risk for medical malpractice claims

Doctors are at an increased risk of medical malpractice claims when the EMR is being implemented and in the initially phase these EMRs can be a thorn in physicians' side.The transition period from a familiar to unfamiliar system introduces risk of error. The impact of the EMRs on the medical malpractice claims, however, is still unclear [4].
When there is malpractice litigation, EMRs can provide clear, complete, organized and legible data and documentation that can prove a malpractice claim. Pre-trial discovery from the EMRs can increase the chances of prosecutors finding some evidence of wrongdoing among an entire team of providers [4].
When there are errors in the accuracy of the clinical content in the EMR or the the manner of presentation of clinical data is poor, the EMR vendor cannot be held liable and the malpractice risk for physician increases. Invariable there will be various limitations related to liability of the EMR vendor in the EMR contract [4]. Another issue that is likely to crop up is, what happens to the old medical records whenever the system is upgraded? Will the complete old records be maintained or only certain screenshots will be maintained due cost constraints.

Likelihood of medical errors

Estimates in the USA show that adverse drug events (ADEs) will injure or kill 770,000 people in hospitals every year [5]. The most common cause of these ADEs is prescribing errors [6]. Computerized physician order entry (CPOE) systems built into the EMRs are expected to reduce prescribing errors and save hundreds of billions in annual costs. However, many believe that too much dependence on an EMR will result in small mistakes quickly turning into medical errors [4].
Koppel et al [7] published a study in 2005 which identified and quantified  the role of CPOE in facilitating prescription error risks. They found that the CPOE systems facilitated 22 different types of medication error risks, which included pharmacy inventory displays being mistaken for ‘dosage guidelines, inflexible ordering formats that generated wrong orders, and CPOE display screens that prevented a coherent view of the patient's medications’[4].  They study also revealed that 75 percent of clinical staff surveyed said that they encountered these error risks weekly or sometimes more often.
Doctors overreliance on functions such as cut and paste can perpetuate mistakes while leaving a trail of errors which are less likely to be discovered and corrected [8]. The cut and paste function also raises issues regarding ownership of the records when a legal investigation is carried out. There are also issues of risk of bugs, viruses or other technological inefficiencies with EMRs which was not there with paper records [8]. An accidental click of the mouse can be dangerous and harmful in some circumstances.

Breaches, theft and unauthorized access to protected health information

Way back in 1996 the US Congress recognized that advances in electronic technology could erode the privacy of health information and the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191, was passed to improve the efficiency and effectiveness of the health care system. HIPAA provisions mandated Federal privacy protections for individually identifiable health information [9]. The Department of Health and Human Safety USA posts all data breaches on a public website. In 2009 there were 2.4 million patients affected by health data breach and in 2010, 5.4 million patients were affected. The most common cause of breaches was theft of patient data. Human error, loss of records and intentional unauthorized access to protected information were the other causes of breaches [4].
The Department of Health & Human Services (HSS) does not take HIPAA violations lightly. In 2011, a computer was stolen from the administrative office of California based Sutter Health which potentially exposed the private data of about 4 million patients. The Department of HHS and the Office for Civil Rights issued a civil money penalty of $4.3 million against Largo, Md.-based Cignet Health for the HIPAA violation. Two days later, HHS and the Office for Civil Rights announced that Massachusetts General Hospital in Boston had agreed to pay $1 million to settle potential HIPAA violations [4].
In Malaysia we have the Personal Data Protection Act 2010 which protects the patients physical and mental health data. Section 9 of the Act (Security Principle) makes the data user responsible for taking practical steps to ‘protect the personal data from any loss, misuse, modification, unauthorized or accidental access or disclosure, alteration or destruction’ [10]. The Act requires protection of the place of storage and the equipment where the data is stored. Measures have to be taken to ensure the reliability, integrity and competence of personnel having access to the personal data; and measures have to be  taken to ensure the secure transfer of the personal data [10].
It is not known if the Personal Data Protection Act 2010 will have the bite of HIPAA or it will remain all bark and no bite as was the case with the HIPAA in its early days.
Hospitals would have to have comprehensive policies and procedures in place and their staff have to be trained to comply with the policies and procedure to prevent breaches, theft and unauthorized access to protected health information. Impermissible use or disclosure of protected patient information should be thoroughly investigated and appropriate remedial action taken. Accurate documentation related to the incident and the investigation should be retained.

What healthcare leaders need to do?

The physicians and other health care workers in the hospital have to be well-informed about compliance and legal risks of the EMRs. The training process is not always easy. Initiatives in EMR education are important to make sure that the doctors and staff do not take legal risks out of ignorance [4].
It can be difficult to train doctors to use the new software because they are usually ‘trained to autonomously practice medicine’ and change is difficult for them. One on one personalised training in a private environment is often most useful and productive. In the one to one environment the doctor can think about and discuss the impact of the software on their workflow [4]. The cooperation between the hospital IT department and the doctors must be enhanced and promoted by the health care leaders.

References

1. PeterChris Okpala.  The Electronic Medical Record (EMR). Journal of Applied Medical Sciences. 2013; 2 (2): 79-85.
2. Roshidi Hassan et al. Implementation of Total Hospital Information System (THIS) In Malaysian Public Hospitals: Challenges and Future Prospects. International Journal of Business and Social Research (IJBSR). 2012;2 (2): 33-41.
3. Perritt HH. Law and the Information Superhighway. 2nd ed. Somerset, NJ: Aspen Publishers; 2009.
4. Molly Gamble. 5 Legal Issues Surrounding Electronic Medical Records. 2012. at https://www.beckershospitalreview.com/legal-regulatory-issues/5-legal-issues-surrounding-electronic-medical-records.html accessed on 28/4/2018.
5. Lesar TS, Lomaestro BM, Pohl H. Medication prescribing errors in a teaching hospital: a 9-year experience.  Arch Intern Med. 1997;157:1569-1576.
6. Leape L, Bates D, Cullen D.  et al.  System analysis of adverse drug events.  JAMA. 1995;274:35-43.
7. Koppel R, Metlay JP, Cohen A, et al. Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors. JAMA. 2005;293(10):1197–1203. doi:10.1001/jama.293.10.1197.
8. Mangalmurti SS, Murtagh L, Mello MM. Medical Malpractice Liability in the Age of Electronic Health Records. N Engl J Med 2010;363(21) 2060-2067. 
9. HIPAA for Professionals; Health Information Privacy; U.S. Department of Health & Human Services at https://www.hhs.gov/hipaa/for-professionals/index.html accessed on 1/5/2018.
10. LAWS OF MALAYSIA ACT 709, PERSONAL DATA PROTECTION ACT 2010 at http://www.pdp.gov.my/images/LAWS_OF_MALAYSIA_PDPA.pdf accessed on 1/5/2018.

Consent to medical treatment and information requirements for a valid consent for medical treatment.

Consent to medical treatment and information requirements for a valid consent for medical treatment.

                                     Dr KS Dhillon LLM

‘Every human being of adult years and sound mind has a right to determine what shall be done with his body; and a surgeon who performs an operation without his patient’s consent, commits an assault’...Benjamin Cardozo, Supreme Court justice, USA

It is trite law that a consent must be obtained from a person with capacity before any examination, test or treatment can be carried out [1]. There is detailed jurisprudence in English law as far as consent to medical intervention  is concerned.The question is whether the patient is asked to consent to physical intervention or to the risks associated with that intervention [2]. Hence there are two types of consent, the ‘real consent’ and an informed consent.

The Tort of Battery and ‘Real’ Consent

A doctor commits a legal wrong of battery or assault if he subjects a patient to physical intervention without valid consent or alternative legal justification.
Legally, for consent to the physical intervention, all that the patient needs to know is, what that physical intervention will involve. Broadly there are three category of situations which can lead to a charge of battery. The most common situation is when a patient is subjected to treatment against his/her will [3]. Sometimes it may involve a situation where a procedure other than the one consented to is carried out [4] or where a patient is deliberately and fraudulently misled [5].
The information provided when obtaining a consent has to be relevant and the information need not be elaborate. The Court in Chatterton v Gerson [6] pointed out that ‘once the patient is informed in broad terms of the nature of the procedure that is intended, and gives her consent that consent is real’. Hence the patient only needs to understand the general nature of the operation for the consent to be valid and therefore the law terms it as ‘real’ consent.
The standard for deciding what information needs to be disclosed to the patient to make the patient ‘broadly aware’ of the nature of intervention and obtain a ‘real’ consent to prevent action in battery is determined by the medical profession [6].
For ‘real’ consent there is no requirement to provide information about risk involved and about other options available. For these reasons ‘real’ consent is easily obtainable.
Informed consent to medical procedure is a more complicated matter.

The Tort of Negligence and ‘Informed Consent

None disclosure of a non-negligent risk associated with an intervention by the clinician, could be actionable in negligence if the risk eventuates since valid consent to those risks was not obtained. Such a consent is known as informed consent. There is a definite difference between ‘real’ and ‘informed’ consent and the information required for informed consent is therefore very different. When giving an informed consent not only information about the the nature of the procedure is needed but also information about the risks associated with the said procedure is needed. Having to consent to possible risk raises the question of alternative procedures and their corresponding risk and also the possibility of non-intervention.
In English law it is evident that doctors have a duty to inform the patient of alternative treatment which have lower risk [7]. Even if the risk is not lower it is duty of doctors to inform the patient of alternative interventions [8].
A failure to disclose the risk and benefits of a procedure and alternative intervention does not render a ‘real consent’ invalid but it would mean that the doctor has not obtained an informed consent.
Action of battery is regarded as inappropriate for interventions without informed consent because the law believes that doctors act in good faith and in the interest of the patient when they carry out medical treatment [6]. Battery on the other hand is associated with bad faith and it is usually carried out intentionally [9]. Therefore, the Courts believe that the doctor must have inadvertently failed to disclose a risk and could not have battered a patients in whose best interest they are acting.
The courts are usually reluctant to entertain a tort of battery in medical cases even when a wrong intervention is performed. A claim in negligence, can in principle, be sought in such cases. Bristow J in Chatterton v Gerson [6] however, felt that trespass would be the appropriate cause of action in such a case.
The level of information required to avoid a charge of battery when obtaining a ‘real consent’ is low. All that is necessary is to make the patient  ‘broadly aware’ of the nature and purpose of the action by reference to the reasonable doctor’s view of what is relevant. The same however is not true as far as informed consent is concerned.
Till 2015, the English Courts used to take a similar position to setting standards, as for ‘real consent’, where a reasonable doctor’s view prevailed, when taking an informed consent.
In Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital [10] relying on the Bolam test [11] the House of Lords held that a patient would be considered to have been adequately informed about the risks if the doctor had disclosed risks which the medical profession thought was reasonable to disclose.
However, in 2015 this reliance on the reasonable doctor’s view changed. In  Montgomery v Lanarkshire Health Board, the Supreme Court  departed from Sidaway in how standards are set by declaring that information
about risks and alternative treatments should no longer be based on Bolam.
The court held that the doctor is:
‘under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it’ [8].
Hence, when obtaining informed consent the level of information that needs to be disclosed has to be referenced to the patient’s perspective, and not that of the doctor.
Though the law of informed consent has been quite clear over the last 30 years, there still remains lack of clarity about the standard used to judge whether a consent is properly ‘informed’ or not. There appears to be significant differences between what the doctor and the patient views as relevant information for medical treatment.  The large numbers of high profile legal challenges concerning non-disclosure of medical risk information, in English law, bears testimony to this fact [12].

What are the elements of full informed consent?

Following the decision by the Supreme Court in Montgomery it has become important that the patient is given an opportunity to be an informed participant in his/her health care decisions. The following points have to be taken into consideration and discussed when obtaining an informed consent:

• The nature of the procedure or intervention has to discussed and the patient should be made to understand what is involved
• The patient has to be made aware of reasonable alternatives to the proposed intervention which are available
• All the relevant risks, benefits, and uncertainties related to each alternative has to be discussed with the patient
• The doctor has to make sure that the patient comprehends the information provided. The discussion should be carried on in layperson's terms
• The patient must be willing to accept the intervention proposed by the doctor

This gives rise to the next question.

How much information is considered "adequate"?

In the past the reasonable physician standard was used to determine how much information has to be provided. That would mean that the doctor would decide how much information to provide the patient about the intervention based on the common practice among doctors. The courts have found that this standard is inadequate since it has become apparent that doctors do not provide a lot information. In the reasonable physician standard the focus is on the doctors rather than on the patient and is inconsistent with the concept of patient autonomy and with the goals of informed consent.
Currently most jurisdictions use the reasonable patient standard for informed consent. It involves providing information which an average patient would want to have to participate in the decision making process.
Patients have to be given sufficient information about the condition, investigation and treatment options, benefits, possible side effects or complications, and the likely outcome if treatment is not undertaken, so that they can make an informed decision to undergo treatment, procedure or operation.
There is a legal duty for the doctor to warn the patient about material risk inherent in the proposed treatment or intervention. ‘Material’ risk was defined in Rogers v. Whitaker  [13]. A risk is ‘material’ in a given circumstance if a reasonable person in the patients position, if warned of the risk, is likely to attach significance to it or if the doctor is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it. Known risks that are common though their detriment is slight and those that are uncommon but their outcome is severe should be disclosed. It is also important to know whether knowing about a risk is likely to influence a patient’s decision. Failure to disclose these risks may be a breach of the doctors duty of care to the patient and this could give rise to legal action for negligence.

Pre-prepared material/brochure and informed consent

Prepared patient information forms and brochures (translated when necessary) are sometimes used in hospitals before obtaining informed consent. These material can be useful for the patient to stimulate discussion about the procedure and its risks and it helps the doctor to guide the direction of the discussion. This material however cannot be used as a substitute to ascertain that the patient has understood the nature and risk of the procedure. Providing this material does not discharge the legal duty of the doctors when obtaining an informed consent. The doctor still has to make sure the patient is aware of the intervention planned and all material risks involved. The doctor has to ask the patient if any of the information provided is unclear. It is the doctor's duty to make sure that the pre-prepared material is up to date, accurate and appropriate for the patients. An inadequate or inaccurate information sheet would mean that that the patient was inadequately informed and this could have legal implication if litigation ensues. When additional information is provided to the patient it should be specifically noted by hand on the information sheet. Interpreters have to be used when there are language problems. In some countries professional interpreters are used when dealing with non-English speaking patients [14].

When can the duty to inform be breached?

The duty to inform the patient cannot usually be breached. However there are two situations where the duty to inform may be breached.

1. Rarely a situation may arise, where the patient expressly directs the doctor to make the decisions and does not want any information that is being provided. In such situations the doctor should at least provide the  basic information about the diagnosis and treatment.
2. On other occasions the duty to inform may be breached when the doctor exercises “therapeutic privilege” and withholds the information, when he holds a reasonable belief that disclosure of the risks could prove damaging to the patient’s health. Here the doctor has to make a judgment call, on reasonable grounds, that the information provided could cause serious harm to the patient’s physical or mental health. Several factors govern therapeutic privilege and this can include the personality, temperament or attitude of the patient as well as their level of understanding. Other factors include the nature of the treatment to be provided and the likelihood and severity of adverse effects which can result from the treatment.

Exercising ‘therapeutic privilege’ denies the patient his /her right to participate in decision making and this privilege should be sparingly used. The scope of this privilege remains uncertain and consultation with other colleagues is useful when making a decision to exercise ‘therapeutic privilege’ [14].

What information should the doctor provide the patient when obtaining the informed consent?

When obtaining an informed consent the following points should be brought up in the discussion with the patient:

1. The possible or most likely illness that the patient has;
2. The planned approach to investigations and treatment, including what the approach entails
3. The expected benefits of the intervention
4. The common side effects and material risk associated with the intervention
5. Whether the procedure is experimental or is conventional and established
6. The person who would be carrying out the procedure
7. Are other options for diagnosis and treatment available
8. The degree of uncertainty involving the the diagnosis and outcome of the intervention
9. What is the likely outcome of not undergoing the intervention for diagnosis and or treatment
10. Long term physical and non-physical adverse effects associated with the proposed intervention [14].

Conclusion

From the legal point of view a consent must be obtained from a person with capacity before any examination, test or treatment can be carried out.
A legal wrong of battery or assault can easily be avoided by obtaining a ‘real consent’ by informing the patient in broad terms the nature of the procedure that is intended. The nature of information to be given to patient to obtain ‘real consent’ is determined by the medical profession.
Obtaining an informed consent on the other hand is more complicated. The law in this area has changed over the years. When obtaining an informed consent the level of information that needs to be disclosed has to be referenced to the patient’s perspective, and not that of the doctor as in the past. Patients now have to be given sufficient information about the condition, investigation and treatment options, benefits, possible side effects or complications, and the likely outcome if treatment is not undertaken, so that they can make an informed decision to undergo treatment, procedure or operation. It is now the legal duty of the doctor to warn the patient about material risk inherent in the proposed treatment or intervention.
Prepared patient information forms and brochures can be used to provide information to the patient. These forms, however, cannot be used as a substitute to ascertain that the patient has understood the nature and risk of the procedure. Providing this material does not discharge the legal duty of the doctors when obtaining an informed consent.
The duty to inform can very rarely be breached. Doctors should use ‘therapeutic privilege’ to withhold information from patients very sparingly, because it denies the patient his /her right to participate in decision making.
Although the law of informed consent has been quite clear over the last 30 years, there still remains lack of clarity about the standard used to judge whether a consent is properly ‘informed’ or not.

References

1. Mental Capacity Act 2005 s.
2. Chico V and Taylor MJ. Using and disclosing confidential patient information and the English common law: What are the information requirements of a valid consent? Medical Law Review, Vol. 26, No. 1, pp. 51–72.
3. Re B (Adult, refusal of medical treatment) [2002] 2 All ER 449; Re C (Adult, refusal of treatment) [1994] 1 All ER 819.
4. Devi v West Midlands RHA [1980] CLY 687.
5. Appleton v Garrett (1997) 8 Med LR 75.
6. Chatterton v Gerson[1981] QB 432, 443.
7. Birch v University College Hospitals NHS Trust [2008] EWHC 2237 (QB).
8. Montgomery v Lanarkshire Health Board [2015] UKSC 11.
9. Wilson v Pringle [1987] QB 237.
10. Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital [1985] UKHL 1.
11. Bolam v Friern Hospital Management Committee [1957] 1 WLR 582.
12. Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital [1985] UKHL 1; Montgomery v Lanarkshire Health Board [2015] UKSC 11; Chester v Afshar [2004] UKHL 41; Al Hamwi v Johnston and another [2005] EWHC 206 (QB) and Pearce v United Bristol Healthcare NHS Trust [1998] EWCA Civ 865.
13. Rogers v Whitaker [1992] HCA 58; (1992) 175 CLR 479.
14. Policy Directive -- Consent to Medical Treatment - Patient Information. Ministry of Health, NSW, Australia at http://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2005_406.pdf accessed on 19/4/18.

Fractures of the distal femur

                                     Fractures of the distal femur 

                                                  Dr KS Dhillon FRCS

Introduction

Distal femur fractures are not common and can be difficult to treat. In the 1960s the common mode of treatment of such fractures was conservative. However with the advent of better fixation devices in the 1970s, surgical fixation of the fractures became the standard mode of treatment. The functional outcome of treatment of such fractures, though many would believe is poor, is according to the literature surprisingly good. Despite the development of post-traumatic osteoarthritis in about a third of the patients the functional outcome remains good in majority of the patients.

Anatomy of the distal femur

The femur becomes trapezoidal in cross section distally where it forms the  knee joint. The medial condyle extends more distal than lateral condyle at the knee joint and the anatomical axis is about 6 to degrees valgus. The posterior halves of the medial and lateral condyles extend posteriorly beyond the posterior cortex of the femoral shaft. In the axial plane the medial femoral cortex slopes about 25 degrees and the lateral cortex slopes about 10 degrees.
The hamstring muscles and the quadricep muscle pull the distal fracture fragment proximally, the adductor magnus displaces it into varus and the gastrocnemius extend the distal fragment.

Epidemiology

Distal femur fractures account for about 6% of all femur fractures and are 10 times less frequent than proximal femur fractures (1).  The most widely used classification for distal femur fractures is the AO/OTA classification (1).

Classification of distal femur fractures.

The AO/OTA classification is widely used to classify the distal femur 

fractures. The fractures are broadly divided into three types. Type A, B and C.

Classification

The distal femur fracture represented by the number 33 and subdivided into three groups:
    1. 33A-- extra-articular metaphyseal fractures which are subdivided into three
         33A.1—simple metaphyseal fracture
         33A.2--- metaphyseal wedge fracture
         33A.3--- metaphyseal complex fracture
    2. 33B-- partial articular fracture which are also divided into three
          33B.1 – lateral sagittal fracture
          33B.2 – medial sagittal fracture
          33B.3--- frontal (Hoffa). Type B3 can be subdivided into three
                          B3.1---anterior and lateral flake
                          B3.2—unicondylar posterior
                          B3.3 – bicondylar posterior

   3. 33C-- complete articular with both condyles detached from the metaphysis.
           33C.1-- articular simple and metaphyseal simple fracture
           33C.2 --- articular simple and metaphyseal multifragmentary fracture
           33C.3 --- multifragmentary articular and metaphyseal fracture
   

Treatment of distal femur fractures

Fractures of the distal femur are fortunately uncommon. They constitute about 0.4% of all fractures and about 3% of femoral fractures[2]. The treatment of these fractures is difficult. In 1966 Stewart et al [3] claimed that "fractures in the distal third of the femur continue to perplex the surgeon. Whether they are transverse, oblique, or comminuted, or supracondylar or intercondylar in a T, Y or V fashion their management still evokes much controversy because of the consistently poor results obtained". However over the years the outcome of treatment has improve with better fixation devices.

Conservative treatment

On rare occasions distal femur fractures can be treated conservatively with a hinged brace and early knee mobilization. Such treatment is useful in patients with undisplaced fractures, in patients who are non-ambulatory and those who are unfit for surgery.

Surgical treatment

Various devices such as external fixators, nails, plates and screws are available to stabilize fractures of the distal femur.

External fixation

External fixators are used to temporarily immobilize the fractured bone till soft tissue healing is adequate for internal fixation of the fracture especially in open fractures. This technique cannot be used for definitive treatment of distal femur fracture because it does not provide adequate stability and it immobilizes the knee joint.

Antegrade intramedullary nailing

Antegrade nailing is indicated in type A extra-articular fractures of the distal femur. It is the method of choice for treatment of segmental femur fractures involving the distal femur.

Retrograde intramedullary nailing

Retrograde nailing is suitable for patients with extra-articular distal femur fracture who have concomitant fracture of the tibia (floating knee) which can be treated though the same approach.
Screw fixation
Type B fractures can be treated with screw fixation through the medial or lateral approach to the condyles. With little or no displacement percutaneous screw fixation is possible. The use of two 6.5 mm screws is  more effective than several 3.5 mm screws for osteosynthesis of these fractures [4]. In the fixation of Hoffa fractures, lag screws placed posterior to anterior provided more stable fixation than anterior posterior placement[5].

Angled blade plate

The 95 degree angled blade plate can be used for stabilization of the supracondylar and intercondylar fractures of the distal femur. The blade plate is preshaped to fit the anatomy of the distal femur.the blade is seated about 2 cm proximal to the knee joint line and the tip of the blade should not protrude beyond medial cortex to prevent damage to the medial structures.

Dynamic condylar screw (DCS)

The 95 degrees DCS is used for similar indications as the angle blade plate. Here the blade is replaced by a cannulated screw which attaches to the plate. The placement is similar to the blade plate.
Plates
There are various plates available to stabilize the distal femur fractures. The older version is the condylar buttress plate and the newer version are the locking condylar buttress plate and the locking compression plate. Plates are useful for fixing more fragile bone especially in the elderly. Biomechanical studies appear to show that locking plates are better than other modes of fixation [6].
A cochrane database systematic review by Griffin et al [7] in 2015, however, found that the currently available evidence for interventions used in treating fractures of the distal femur in adults, is incomplete and insufficient to inform current clinical practice.

Outcome of treatment of distal femur fractures

There is paucity of literature on the long term outcome of treatment of distal femoral fractures.
Egund and Kolmert [8] retrospectively reviewed 62 patients with distal femur fractures at a mean follow up of 5 years. Some of the patients were treated with traction and others had open reduction and internal fixation. They found that displaced bicondylar fractures healed mostly with varus and anterior angulation, medial unicondylar fractures with varus and lateral unicondylar fractures with valgus angulation. Most of the healed supracondylar fractures showed varus angulation. Three patients (5.8%) developed arthrosis in the femoro-tibial (grade I or II) and 14 patients (27%) had OA of  the patellar area. Intercondylar or transcondylar diastasis, or step off of 3 mm or more predisposed the patients to osteoarthritis.
Rademakers et al [9] conducted a retrospective study to analyze the long-term (5–25 years) functional and radiologic outcome of surgically treated intra-articular fractures of the distal femur. They studied 67 consecutive patients with intra articular fractures of the distal femur. Thirty-two patients had a long term follow up with functional and radiological evaluation . At a mean follow-up of 14 years (range 5–25 years), the mean range of knee flexion was 118° (range 10–145°). The Neer score showed good to excellent results in 84% of the patients and HSS score was good to excellent in 75% of the patients. Patients with isolated fractures of the distal femur had significantly better functional scores (Neer/HSS 90 points) compared with those with multiple fractures.
The Ahlbäck score showed a moderate to severe posttraumatic osteoarthritis in 36% of all patients. Despite the OA, 72% of the patients  scored a good to excellent functional result. Ten percent (seven patients) of the patients had deep wound infection and in two patients the infection became chronic and they had knee arthrodesis.
Thomson et al [10] reported a 50% incidence of OA in 22 patients (23 fractures) with type C distal femur fractures who were followed up for a mean period of 80 months (6.6 years). The physical function component of the SF-36 was approximately 2 standard deviations below the US population mean. None of the patients had a subsequent knee replacement.
Another long term follow up study of supracondylar fractures of the femur was published  by Kolb et al (11). They retrospectively studied the outcome in 41 patients with supracondylar fracture of the femur. Eighty percent of the patients were followed up for a mean of 9.5 years (7-12 years). They found that the mean Neer score was 82 points with a score of 89 points in isolated supracondylar fractures and 72 points in patients with associated fractures. The results were good to excellent in 82% of the patients. No mention was made of OA of the knee in this study.

Conclusion

Fractures of the distal femur are not common. They can occur in isolation or may occur in combination with other fractures. The AO/OTA classification of distal femur fractures is widely used and has prognostic significance. Unlike in the past, distal femur fractures are now routinely treated surgically. Various fixation devices are available. There is no evidence of superiority of one device over the other. The functional outcome of treatment is good to excellent in vast majority of the patients.The outcome is better in patients with isolated fractures as compared to those with combination injuries. About one third of the patients develop post-traumatic osteoarthritis. Despite the presences of post-traumatic OA, over 70% of the patients with OA have good to excellent functional outcome.

References

1. Florian Gebhard, Phil Kregor, Chris Oliver. AO Surgery Reference - AOTrauma - AO Foundation at https://www2.aofoundation.org Accessed on 10/11/2016. 
2. Court-Brown M, Caesar B. Epidemiology of adult fracture: a review. Injury. 2006; 37: 691-697.
3. Stewart M J., Sisk T D. Wallace S L. Fractures of the distal third of the femur. J. Bone Joint Surg. 1966; 48-A: 784-807.
4. Khalafi A, Hazelwood S, Curtiss S, Wolinski P. Fixation of the femoral condyles: a mechanical comparison of small and large fragment screw fixation. J Trauma. 2008; 64: 740-744.
5. Jarit GJ, Kummer FJ, Gibber MJ, Egol KA. A mechanical evaluation of two fixation methods using cancellous screws for coronal fractures of the lateral condyle of the distal femur (OTA type 33B). J Orthop Trauma. 2006; 20: 273-276.
6. Ehlinger M, Ducrot G, Adam P, Bonnomet F. Distal femur fractures. Surgical techniques and a review of the literature. Orthopaedics & Traumatology: Surgery & Research. 2013; 99(3): 353-360.
7. Griffin XL, Parsons N, Zbaeda MM, McArthur J. Interventions for treating fractures of the distal femur in adults. Cochrane Database Syst Rev. 2015 Aug 13;(8):CD010606. doi: 10.1002/14651858. CD010606.pub2.
8. Egund N and KolmertL. Deformities, Gonarthrosis and Function After Distal Femoral Fractures, Acta Orthopaedica Scandinavica. 2009; 53:6: 963-974.
9. Rademakers MV. Kerkhoffs GMM, Sierevelt IN, Raaymakers EL, Marti RK. Intra-Articular Fractures of the Distal Femur: A Long-Term Follow-up Study of Surgically Treated Patients. Journal of Orthopaedic Trauma. 2004;18 (4): 213-219.
10. Thomson AB, Driver R, Kregor PJ, Obremskey WT. Long-term functional outcomes after intra-articular distal femur fractures: ORIF versus retrograde intramedullary nailing. Orthopedics. 2008 Aug;31(8):748-50.
11. Kolb K, Grutzner P, Koller H, Windisch C, Marx F, Kolb W. The condylar plate for treatment of distal femoral fractures: a long-term follow-up study. Injury. 2009;40(4):440–8. doi: 10.1016/j.injury. 2008.08.046.

Orthopaedic surgeon as an expert witness in medicolegal proceedings

         Orthopaedic surgeon as an expert witness in medicolegal proceedings

                                                    KS Dhillon LLM

Introduction

Orthopaedic surgeons are increasingly being requested by solicitors to provide medical reports for medicolegal proceedings and to appear in court as an expert witness. There is not much information available to malaysian orthopaedic surgeons who are increasingly getting involved in such medicolegal work. This area of expertise is not included in our undergraduate or postgraduate curriculum. The Malaysian Medical Council (MMC) website provides some information under the section on ‘Ethical Code & Guidelines’ and subsection ‘Expert Witness’ (1). The latest amendment of the section on expert witness by the Malaysian Medical Council was at its meeting on 17 May 2016 (2). However the amendments do not amount to significant reforms.

Expert Witness Guidelines

The Malaysian Medical Council Expert Witness Guidelines define who is an expert witness and what qualifications are necessary to be an expert witness. It also outlines the responsibilities of an expert witness. The guidelines describes what expert evidence is and what a expert report should contain. It also advises on what to do when there is conflict of interest with regards to the patient or any other party.
In the introductory preamble of the guidelines the following paragraph appears ‘[t]he MMC’s guidance “Good Medical Practice” sets out the principles which underpin good care. When registered medical practitioners (“RMP”) act as expert witnesses, they take on a different role from that of a RMP providing treatment or advice to patients. However, the principles set out in “Good Medical Practice” also apply to RMPs who are expert witness’.
A in depth reading of the good medical practice guidelines shows that the guidance is mainly about doctor patient relationship and not about how to be a good expert witness. There should be a distinction between an individual who is a patient and who is a litigant.The rules that govern dealing with a patient and that when acting as an expert witness are different. However the Malaysian guidelines do not provide any clarity on this subject.
The Australian guideline on ‘Good Medical Practice’ on the other hand makes a clear distinction between these two roles (3). At 8.7 under the heading ‘Medico-legal, insurance and other assessments’ the guideline states that ‘[w]hen you are contracted by a third party to provide a medico-legal, insurance or other assessment of a person who is not your patient, the usual therapeutic doctor–patient relationship does not exist’. In such a situation good medical practice involves being courteous and alert to the needs of the person and to obtain consent and also to explain the reason  for the assessment and after the assessment to provide an impartial report. If any unrecognised serious medical problem is discovered during the examination, it is the duty of the doctor to inform the person or his/her treating doctor.
Probably the most comprehensive guidelines for doctors is the American Medical Association (AMA) Code of Medical Ethics 2016 (4). The guidelines have a separate comprehensive section on medical testimony at section 9.7.1. This section stresses on the importance of medical evidence in various administrative and legal proceedings and obligation of doctors to assist in the administration of justice. The guideline emphasises on the need to be honest and impartial and that the testimony should not be influenced by financial consideration. The guideline warns against receiving compensations that are ‘contingent on the outcome of litigation’.
Doctors who act as fact witnesses, for their patients, in legal claim, must remember the importance of confidentiality. The testimony should reflect facts of the case and honesty is of paramount importance.
Expert witnesses should only testify in their area of training and experience. The testimony should be objective and independent and it should reflect  the ‘current scientific thought and standards of care that have gained acceptance among peers in the relevant field’ at the time when the incident happened. Theoretical testimony should be avoided but if that is not possible, then the basis of the theory should be characterised.
In the USA, state medical licensing board and the specialty societies are entrusted with the responsibility of assessing ‘claims of false or misleading testimony and issuing disciplinary sanctions as appropriate’, to maintain high standards of medical testimony.
In the USA several medical specialities have established their own guidelines based on the ethical standards set by AMA (5). The American  Academy of Orthopaedic Surgeons (AAOS)  has produced its own code of medical ethics and professionalism for orthopaedic surgeons (6).
 In the UK, similar guidelines are available for witnesses of fact and expert witnesses. The guidelines are set in a 4 pages document produced by the General Medical Council in 2013(7). It stresses on the need for honesty, confidentiality, competence, knowledge, being up to date and the need to work within the limits of one's competence, beside being always impartial. It also reminds the doctors that in providing medical testimony the doctor’s overriding duty is to the court, irrespective who is instructing or paying the doctor.
The guidelines, however, are silent about other important aspects of medical testimony such as judicial immunity of expert witness, penalty for false testimony and possible sanctions by regulatory bodies.

Judicial Immunity of the Expert Witness

Historically, in English law, witnesses in legal proceedings have enjoyed judicial immunity since Cutler v Dixon: KBD 1585 (8). Evidence provided by an expert witness was protected from civil liability. The basis of this immunity is public policy considerations where there is an assumption that if there is a risk of civil proceeding based on the evidence, then the witness will not be willing to provide frank and full evidence. This however changed when the Supreme Court of the United Kingdom on 30 March 2011 abolished this immunity in Jones v Kaney [2011] UKSC 13, by a 5-2 majority (9). The majority was of the opinion that the reason for the immunity, that the witness would be reluctant to provide true opinion and that there may be a proliferation of vexatious claim is no longer tenable. The majority were of the opinion that the court has to respect the fundamental rule that every wrong should have a remedy which is the cornerstone of any system of justice. However the immunity to a defamation civil suit would continue.
Following this decision in Jones v Kaney things may change for both the expert witness and the maybe for the client as well, although the British Courts do not believe it will happen. Now that a client who believes he has been wronged by the expert testimony may file a legal redress against the expert which in turn may result in shortage of experts available who are willing to testify. So far this landmark decision is not binding in Malaysia and judicial immunity of the expert witness remains.
In Australia too the doctrine of immunity for expert witnesses is still in force.  In Commonwealth of Australia v Griffiths[10] the court confirmed that the key objectives of the doctrine is to make sure that the expert witness is able to  give evidence freely; and also to make sure that the same evidence is not tried repeatedly in multiple actions. This immunity, as in UK, does not extend to considerations of the expert’s conduct by the regulatory professional bodies.
In the USA there has been a gradual erosion of the expert immunity over the years and now most courts ‘view professional witness malpractice as an actionable claim’ (11). Most often the party hiring the expert sues the expert for negligence and less often the expert hired by the opposing counsel gets sued (11).
What happens if the expert witness provides false testimony?

False testimony

A doctor who provides false testimony under oath or lies in his deposition when acting as an expert can be prosecuted for the crime of perjury. The statement made must, however, be “material” to the subject of the proceeding.There is no immunity for lying in sworn testimony. The prosecution for perjury is carried out by the government prosecutors and not by any of the parties involved in the litigation.
In Malaysian law, false evidence is defined under section 191 of Act 574, of the penal code. The Act defines false evidence as ‘whoever, being legally bound by an oath, or by any express provision of law to state the truth, or being bound by law to make a declaration upon any subject, makes any statement which is false, and which he either knows or believes to be false, or does not believe to be true, is said to give false evidence’.
The punishment for false evidence is provided for under section 193 of the same Act. It states that ‘whoever intentionally gives false evidence in any stage of a judicial proceeding, or fabricates false evidence for the purpose of being used in any stage of a judicial proceeding, shall be punished with
imprisonment for a term which may extend to seven years, and shall
also be liable to fine…’ (12).
Besides the government, state authorities or professional bodies can also mete out punishment for expert witness malfeasance.

Sanctions by state authority and/or professional body. 

There are three systems that operate to regulate expert medical testimony in most countries. This would include the legislature, the judiciary and medical regulatory bodies such as the medical council or the medical professional organizations (13). There are precedents in the USA and the UK where medical regulatory bodies have taken disciplinary action against doctors for expert witness malfeasance.
In the USA, Dr Austin, a neurosurgeon and member of American Association of Neurological Surgeons (AANS), had his membership suspended by the AANS after he testified as an expert for the plaintiff against Dr Ditmore, another member of AANS. At the conclusion of the malpractice trial, Dr. Ditmore complained to the AANS about Dr. Austin’s medical testimony. Investigations by the AANS showed that Dr. Austin’s
testimony did not have evidentiary basis and had violated AANS expert witness guidelines and the AANS ethics code. Dr. Austin subsequently sued the AANS,without success (14).
In the UK, the most well known case of disciplinary action by General medical Council (GMC) for expert witness malfeasance was that involving Professor Sir Roy Meadow. His name was struck off the medical register by the Fitness to Practise Panel (FPP) of the General Medical Council (GMC) in 2005, following a complaint by Sally Clark’s father. He was found guilty of serious professional misconduct for providing statistical evidence that was inaccurate and misleading at the trial of Sally Clark who was convicted of killing her two children. She was, however, subsequently released after the second appeal.   
Professor Meadow appealed to the High Court and the High court in February 2006 allowed his appeal and quashed the order of the GMC. The GMC appealed to the Appeals Court in July 2006. At the Appeal Court, the Master of the Rolls, Sir Anthony Clarke MR, broke down the appeal into two parts, the first being whether an expert witness has immunity from disciplinary proceeding by the GMC for evidence given by him at legal proceedings. The second was an appeal by the GMC to squash the High Court Judge’s ruling that Professor Meadow was not guilty of serious professional misconduct.
 The Appeals Court unanimously concluded that FPP had jurisdiction to entertain the allegations against Professor Meadow, which in essence meant that there is no expert witness immunity from disciplinary proceeding by the GMC for evidence given in legal proceeding.
The Appeals Court with a majority of two to one upheld the decision of the High Court Judge that Professor Meadow was not guilty of professional misconduct and dismissed the GMC appeal on this important matter (15).
A more recent case, in UK, involved a paediatric neuropathologist, Dr Waney Squier (16). A panel of the Medical Practitioners Tribunal Service (MPTS), the statutory successor to the FTPP, decided to strike her name off the medical register for expert witness malfeasance in the “shaken baby” cases. She appealed to the High Court. At the High Court, the judge, Mr Justice Mitting acquitted her of dishonest testimony and he found that the tribunal's determinations were “in many significant respects flawed.”
The judge made several interesting concluding observations. He was of the opinion that since this case before the MPTS was a complex case which required ‘an understanding of the context in which expert evidence is given in a court’, it would have been proper to have a lawyer with judicial experience as the chair of the inquiry. The rules of General Medical Council (Constitution of Panels, Tribunals and Investigation Committee) 2015 do not prohibit such an appointment. The Judge’s comments probable meant that if a lawyer with judicial experience had been appointed as the chair, the shortcomings in the tribunal's determinations could have been avoided. This would have prevented pain and suffering for the accused and also save time and money for all parties involved.
In the UK, doctors can be prosecuted again after acquittal by the GMC, although there is law against double jeopardy in most countries. The Council for Healthcare Regulatory Excellence (CHRE) has the powers to refer a doctor to the High Court after they have been acquitted of of serious professional misconduct by the GMC. The first case of this nature involved Dr Ruscillo (a GP) who was found to be not guilty of serious professional misconduct by the GMC but the CHRE felt it was an unduly lenient penalty.
The Council appealed the acquittal and Dr Ruscillo challenged the appeal.The case went to the Court of Appeal and the court held that this acquittal could be a subject of an appeal according the law (17).
Although, regulatory bodies such as the Malaysian medical council and the GMC do mete out punishment to errant expert witnesses, these regulatory bodies can also err.

Failings of the regulatory bodies

The body that regulates and sanctions doctors in Malaysia is the Malaysian Medical Council. The president of the Council is the director general of health and the council has 11 elected members who are doctors and three nominated member from the civil service who are also doctors. In addition there 18 nominated member from six universities who are also doctors (18) Hence in Malaysia the doctors set the standards and they regulate themselves. In the UK too, self-regulation which provided a lot of freedom in dealing with problems within the profession was the norm till the GMC came under lot of condemnation following the Bristol Inquiry (19) and Shipman Inquiry (20).
Between 1991 and 1995 at the Bristol Royal Infirmary cardiac unit there was an unusually high death rate among children going for heart surgery due to poor care, and poor team work. The problems were brought to light by whistleblower, consultant anaesthetist Dr Stephen Bolsin who could not get a job in UK after the exposure and had to migrate to Australia.The Bristol inquiry resulted in several reforms by the government and professional bodies.
Dame Janet Smith headed the Shipman Inquiry which looked into issues arising from the case of Dr Harold Shipman (GP) who murdered over 200 of his patients. The inquiry did a thorough forensic examination of the GMC and found it to be severely wanting. The GMC had been accused of being a judge and prosecutor (21). Dame Janet Smith’s fifth report which was over 1000 pages long made several recommendation for reforms to the GMC (22).
There have been many amendments to the 1983 medical act (UK) and last being in 2016. The GMC is an independent body which now has lay members besides the medical members. Complaints against doctors are investigated by the GMC. Two senior GMC staff who are known as case examiners (one medical and one non-medical) look into the complaints and they can come to the following conclusion:

• No further action
• Issue a warning
• Agree undertakings - for example to re-train or work under supervision.
• Refer the case to a medical practitioners tribunal (MPT) of the Medical Practitioners Tribunal Service (MPTS) when action on registration may be appropriate.

The Medical Practitioners Tribunal Service is an independent body which reports to GMC twice a year and also to parliament. It carries out hearings for doctors whose fitness to practise is suspect. The tribunal has both medical and lay members.
Although there have been major reforms in the the regulatory bodies in the UK, to date no such reforms have been carried out in Malaysia. The Malaysia Medical Council is not an independent body unlike the GMC. It is an arm of the ministry of health and is financed by the ministry of health. It is regulated by doctors with no representatives from advocacy groups and the council has no lay members to represent the lay complainants (23). The MMC appears to be ‘largely representative of stakeholder groups in the medical profession’ (23). The public perception is that as far as the MMC is concerned the medical profession comes first and that the regulatory process does not appear to safeguard public interest (23). Inquires on the scale of the likes of the Bristol and Shipman inquiry have not and are unlikely to happen in Malaysia in future.

Conclusion

More and more malaysian orthopaedic surgeon’s are getting involved in medicolegal work especially in third party personal injury claims and also some in medical negligence proceedings. However there is not much information available to these surgeons to prepare them for this new role which is very different from the usual one of providing treatment or advice to patients. The rules that govern dealing with a patient and that when acting as an expert witness are different and the Australian Medical Council has made a clear distinction between the two roles, although the MMC believes that the same rules apply to both roles.
Since 2011, UK law does not provide judicial immunity to expert witnesses against civil proceeding. Proceedings against defamation remain in the UK. However, in Malaysia, expert witnesses still enjoy immunity against civil proceedings. There is no immunity for expert witnesses, from criminal proceeding, for false testimony.
Regulatory bodies such as the the MMC and the GMC can take disciplinary action against doctors for expert witness malfeasance. This can include erasure of the name from the medical register.
Failings of the GMC had invited a lot of public criticism in the past which led to a series of reforms to improve its function and image. However no major reforms have occurred in the MMC over the years although the malaysian model of governance is usually based on the British model.

References

1. Official portal of Malaysian Medical Council. Safeguarding patients, guiding doctors at http://www.mmc.gov.my/index.php/ethical-code-guidelines, acessed on 4/9/2017.
2. Expert witness at http://www.mmc.gov.my/images/contents/ethical/Expert%20Witness_17052016.pdf,  accessed on 4/9/2017.
3. Good medical practice: a code of conduct for doctors in Australia at http://www.medicalboard.gov.au/Codes-Guidelines-Policies/Code-of-conduct.aspx, accessed on 4/9/2017.
4. AMA Code of Medical Ethics at https://www.ama-assn.org/delivering-care/ama-code-medical-ethics, accessed on 4/9/2017.
5.  Kass JS and Rose RV. Ethical Challenges for the Medical Expert Witness. AMA Journal of Ethics. 2016; Volume 18, Number 3: 201-208.
6. Code of medical ethics and professionalism for orthopaedic surgeons at https://www.aaos.org/WorkArea/DownloadAsset.aspx?id=31334, accessed on 5/9/2017.
7. Acting as a witness in legal proceedings  at http://www.gmc-uk.org/Acting_as_a_witness_in_legal_proceedings.pdf_58832681.pdf, accessed on 4/9/2017.
8. Cutler v Dixon KBD ((1585) 4 Co Rep 14b, [1585] 76 ER 886,[1585] EngR 96).
9. Jones v Kaney SC 135 Con LR 1, [2011] 2 WLR 823, [2011] BLR 283, [2011] 2 AC 398, [2011] 14 EG 95, [2011] 2 All ER 671, [2011] UKSC 13, UKSC 2010/0034.
10. Commonwealth of Australia v Griffiths and Another (2007) 70 NSWLR 268; [2007] NSWCA 370.
11.  Bal BS. The Expert Witness in Medical Malpractice Litigation. Clin Orthop Relat Res. 2009 Feb; 467(2): 383–391.
12. LAWS OF MALAYSIA, Act 574, PENAL CODE, as at 1 January 2015, at http://www.agc.gov.my/agcportal/uploads/files/Publications/LOM/EN/Penal%20Code%20%5BAct%20574%5D2.pdf. Accessed on 9/92017.
13. Kesselheim AS and Studdert DM, Role of Professional Organizations in Regulating Physician Expert Witness Testimony, JAMA. 2008;299(14):1667-1668.
14. U.S. District Court for the Northern District of Illinois. Austin v. American Ass'n of Neurological Surgeons, 120 F. Supp. 2d 1151 (N.D. Ill. 2000).
15. General Medical Council v Meadow [2006] EWCA Civ 1390.
16. Squier v GMC [2016] EWHC 2739 (Admin).
17. Ruscillo v The Council for the Regulation of Health Care Professionals [2004] EWCA Civ 1356.
18. Malaysian Medical Council at http://www.mmc.gov.my/index.php/council, accessed on 11/9/2017.
19. Learning from Bristol: the report of the public inquiry into children's heart surgery at the Bristol Royal Infirmary 1984 -1995, at http://webarchive.nationalarchives.gov.uk/20090811143746/http://www.bristol-inquiry.org.uk/ accessed on 11/9/2017.
20. The Shipman report at http://webarchive.nationalarchives.gov.uk/20090808160144/http://www.the-shipman-inquiry.org.uk/fifthreport.asp, accessed on 11/9/2017.
21. Smith R. The GMC: expediency before principle. BMJ. 2005 Jan 1;330(7481):1-2.
22. The General Medical Council, The Shipman Inquiry: The fifth report at http://www.gmc-uk.org/6a_The_Shipman_InquiryThe_Fifth_Report.pdf_25398772.pdf, accessed on 11/9/2017.
23. Nik Rosnah & Wan Abdullah. Medical Regulation in Malaysia: Towards an Effective Regulatory Regime.Policy and Society, 2002;21(1): 96-124.