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Risk factors for iatrogenic opioid dependence: An Australian perspective

The prescription of opioids is increasing worldwide, including in Australia. Consequently, opioid dependence – one of several harms associated with chronic opioid therapy – is now a growing concern. However, the risk factors for iatrogenic opioid dependence are not well understood in an Australian context. The available Australian evidence for these risks are reviewed and supplemented with data from the United States. Substance use disorder, mental disorder, pain severity and several demographic factors are associated with increased risk of opioid dependence. Factors originating within the health system, such as prescribed dose, chronicity, monitoring systems and physician attitudes may also contribute to patients developing dependence. Australian data represents a significant gap in the knowledge, and there is a need for good quality studies examining Australian populations.

Background07

The rate of opioid prescribing both in Australia and worldwide has increased dramatically. [1-3] Opioid-like analgesic dispensing in Australia increased 53% between 2002 and 2009, with tramadol and oxycodone showing the largest increases. [1] This prescribing pattern is of concern since chronic opioid therapy is associated with multiple harms, including dependence and accidental overdose. [4,5] In the USA, prescription opioid-related deaths increased 68% between 1999 and 2003, [6] with the highest risk of death in patients who were prescribed high dose opioid therapy. [7] This trend has been mirrored to a lesser extent in Australia, with an increase in oxycodone-related deaths but not morphine-related deaths. [2] There is evidence that harms related to opioid therapy are increasing as a result of increased prescriptions. [2,8]

Iatrogenic dependence can be described as physician initiated inadvertent dependence. [9] The risk of iatrogenic opioid dependence is unknown and estimates differ greatly between acute and chronic settings. [4,10,11]  In  addition,  opioid  therapy  trials  tend  to  focus on efficacy and exclude individuals at high risk of dependence. [12] Despite these limitations, studies of patients taking chronic opioid therapy found a 35% lifetime prevalence of dependence. [4,13] As a consequence, iatrogenic opioid dependence is of concern for health professionals and balancing benefits with risk of dependence is a key clinical issue. [8,14,15]

The terminology used to define and describe the use of opioids is controversial. [16,17] There are two main diagnostic systems for the diagnosis of drug use disorders internationally. The DSM-V describes “substance use disorder” as a mild to severe state of chronically relapsing, compulsive drug taking. [18] The International Classification of Diseases (ICD-10) defines a “dependence syndrome” as a cluster of physiological, behavioural and cognitive phenomena in which the use of a substance takes on a much higher priority for a given individual than other behaviours that once had greater value. [19] Addiction is a term widely used by the general public, health professionals and in the literature. [17] It is described as a chronic condition characterised by behaviours such as compulsive use, continued use despite harm and craving. [16] It has been argued that the term “addiction” represents a variety of social and cultural constructs and is often value-laden. [17] For this reason, the term “dependence” is often preferred. [17] In this article, dependence will be used to describe a diagnosed drug use disorder. Readers should view dependence as distinct from physical dependence, tolerance, abuse and misuse, which are clarified in Table 1.

08

Guidelines for the prescription of opioids are conflicting, with confusion around safety and efficacy. [20,21] The United States has the highest rates of opioid use in the world and multiple reviews have examined the potential risk factors for addiction. [22,23] However, differences in prescribing, demographics and health system characteristics indicate that a review in an Australian context is of value. [1] This article summarises the available Australian evidence on the risk of iatrogenic opioid dependence, supplemented with studies from the US. Four major groups of patient risk factors are described: substance abuse disorder, mental disorder, pain severity and demographic factors. The role of dependence risk screening tools is briefly assessed.Finally, the contribution of specific health system and prescribing factors is discussed.

Methods

A literature search of publications relating to risk factors for prescription opioid dependence was undertaken. The databases PubMed, CINAHL and  Ovid  were searched  for  publications published  between 2004 and 2014. The search terms “Opioid OR Opiate” and “Dependence OR Addiction” and “Prescription” and “Risk” were used. This search yielded 205 publications. Additional articles were obtained from bibliographic searching. 39 relevant articles were included. 166 articles were excluded as they studied heroin use or focused on harms other than dependence, such as abuse or misuse.

Patient factors that increase risk

Substance use disorder

Despite substance abuse being a strong predictor for opioid dependence, Australian data on the relationship is lacking. Cross- sectional studies from the United States demonstrate a strong correlation  between  substance  abuse  disorder  and  chronic  opioid use. [24,25] In addition, evidence suggests that opioid dependence is more likely in those with a past or current substance abuse disorder. [4,8,26,27] This is consistent with a longitudinal study in which a diagnosis of non-opioid substance abuse was the strongest predictor of opioid dependence in those commencing opioid therapy. [15] Recent studies also demonstrate an association between smoking and opioid dependence, with one citing smoking as the most frequently reported risk factor in their cohort. [28,29] No Australian studies were found that  examined  this  relationship.  However,  the  Australian  National Drug Strategy Household Survey reported that 36% of recent users of opioids for non-medical reasons also used cannabis and 25% had used alcohol. [30] This data should be interpreted cautiously, as it does not reveal if the use was chronic or acute, or the reasons for use. At best it shows a tendency for opioids to be used with other psychoactive substances.

Mental disorders

Mental disorders increase the risk of iatrogenic opioid dependence. This is demonstrated by the fact that prescription opioid use is greater for patients with depression and anxiety. [25] Furthermore, these patients were prescribed opioids in higher doses and for longer durations than patients without a mental disorder. [24] Patients with mental disorders also have a higher incidence of chronic non-cancer pain. [24] Whether chronic pain is the cause or result of mental disorders is unknown; some evidence suggests the relationship is bidirectional. [24] Whether more opioids are prescribed to these patients on the basis of their higher reported pain remains to be established.

The outcomes of opioid treatment for patients with mental disorders are  not  well  characterised  as  these  patients  are  usually  excluded from clinical trials. [31] However, several studies show that mental disorders are significantly associated with opioid dependence. [4,8,15,26,27,29,32] Furthermore, having two comorbid mental disorders increases the risk of addiction compared to a single mental disorder. [8] One study found a correlation between PTSD severity and opioid use, suggesting that severity of symptoms may also be implicated. [33]

Despite the increased risk of opioid dependence with mental disorders, one longitudinal study of fifteen thousand veterans with chronic prescription opioid use in the United States showed that only 3% of pain patients with comorbid mental disorders progressed to opioid abuse or dependence. [15] This highlights that the presence of a mental disorder alone cannot predict a patient’s risk of developing dependence to a prescribed opioid. There is a lack of Australian data establishing a link between mental disorders and opioid dependence.

Patient demographics

There are a number of demographic factors that may increase the risk of a patient developing opioid dependence. Studies conducted in the US have identified younger age as a strong predictor of opioid dependence, with individuals under 65 showing increased risk. [4,8,15] In Australia, the National Drug Strategy Household Survey (NDSHS) found that use of opioids for non-medical purposes was highest in persons ages 20-29. [30] As in other substance use disorders, men are more likely to develop opioid abuse or dependence than women. [8,15,26] This is consistent with NDSHS, which found that men were more likely to use pharmaceuticals for non-medical purposes in their lifetime. [30] Several  other  factors such as living rurally and early age of exposure to nicotine, alcohol and other drugs are significantly associated with opioid dependence. [27] In addition, a family history of substance use disorder and time spent in jail may increase the risk. [26] Being divorced, single or separated and childhood emotional trauma are also associated with opioid dependence. [4,15] It is possible that these factors interrelate and are thus more likely to occur together, compounding the risk.

A recent Australian study analysed data from the Bettering the Evaluation and Care of Health (BEACH) program, which collects data on interactions patient consultations in general practice. It found that Commonwealth Concession Card holders had a significantly higher rate of opioid prescribing compared to other patients. [34] This data poses an interesting question as to why opioid prescribing in this population is higher. Possibilities include increased willingness of doctors to prescribe and lack of access to alternative treatments such as physiotherapy.

Pain severity

The severity of a patient’s pain may contribute to opioid addiction. [35] Persistent use of opioids for chronic pain is associated with severe or very severe reported pain. [36] In addition, opioid-dependent individuals show a greater degree of pain-related limitation and greater pain severity. [4,26] This may be because addiction lowers the pain tolerance, or that a lower pain threshold confers an increased risk of addiction. [26,37] Alternatively, people experiencing greater pain severity may simply be prescribed higher doses of opioids. This could also be due to opioid-induced hyperalgesia, a state of nociceptive sensitization caused by exposure to opioids. [38] This can be mistaken for tolerance, which may result in a higher dose of opioids prescribed and thus an increased risk of addiction. No Australian studies were found examining the relationship between pain severity and increased risk of addiction.

Screening for risk

Ultimately, established risk factors should be used to create reliable screening strategies. While that is considered good practice, there is no one screening procedure that can identify chronic pain patients at risk of opioid dependence. [21,22] A common issue is the overlap of behaviours also seen in patients with undertreated pain, such as demand  for  higher  dose  medications,  and  taking  medication  in  a way other than prescribed (defined as misuse). [22] This is further complicated by the fact that established risk factors have been found to be poorly associated with aberrant drug behaviours. [29]

The Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R, https://www.painedu.org/soapp.asp) tool is a self- administered 24-item tool assessing common risk factors for opioid misuse, abuse and dependence. [39] The items assess mood, attitudes towards treatment, personality traits and substance use disorder. [39] A recent study found the SOAPP score to be the strongest predictor of dependence in a cohort of patients using over the counter and prescription painkillers. [40] In addition, Butler et.al found the SOAPP-R to be reliable and valid across two different chronic pain patient populations. [39,41] However, the usefulness of SOAPP-R in a primary health care setting remains to be determined. [39]

The American Society of Interventional Pain Physicians does not recommend the use of formal dependence risk screening tools. [21] In their recent guidelines for responsible opioid prescribing, they suggest that risk stratification can be achieved through a comprehensive physician’s assessment. [21] This should include psychosocial history, functional status, psychological evaluation, substance abuse history and physical exam. [21]

Health system factors contribute to risk

In  addition  to  patient  factors,  there  are  multiple  health  system factors  that  contribute  to  prescription  opioid  dependence.  These are prescribing dose, duration of therapy, monitoring systems and physician attitudes.

Few studies have examined the relationship between dose and duration of therapy and risk of dependence. However, in a large cross-section study of individuals with a new episode of chronic non-cancer pain, those prescribed high morphine equivalent dose (120 mg), chronic (>90 days) opioid therapy were 50 times more likely to develop dependence than those on low dose acute therapy. [8] This is consistent with a recent study, which found the odds ratio for developing dependence with high dose, chronic opioid use was 122.45. [11] While the rate of high dose chronic opioid prescription in this sample was relatively low (0.1% of chronic pain patients), it represents a number needed to harm of 16.7. [8] Given the significant negative consequences of opioid dependence this number needed to harm may be unacceptable. Multiple studies found that duration of opioid therapy was more important than daily dose in determining risk of dependence. [8,11,42] Indeed, data suggests that other risk factors such as younger age and comorbid mental disorders contributed less to the risk than dose and chronicity alone. [8] This is supported by another study which found that greater than 211 days of prescribed opioids was more predictive of dependence than 90-211 days. [15] Importantly, this also suggests that the association between risk and chronicity is a linear relationship. In Australia stronger formulations account for the minority of opioids prescribed. [2] However, more research into the relationship between opioid dose, chronicity and dependence is required.

One of the goals of responsible opioid prescribing is adequate monitoring, due to the consequences of duration mentioned above. [5,21] Existing monitoring systems in Australia cannot track opioid prescriptions and supply down to the individual patient level. [5] The Pharmaceutical Benefit Schedule (PBS) data set generates a Medicare file,  which  can  potentially  identify  patients  misusing  opioids.  [5]

However, no information is included in the PBS record if a patient pays the entire cost of the medication. [5] Lack of access to comprehensive information can contribute to inappropriate prescribing. [43] Thus, a real-time prescription coordination program making use of technology would be greatly beneficial. [43]

Physician attitudes towards opioid analgesics may also profoundly impact on treatment. [14] In a mailed survey to General Practitioners in Ontario, GPs who did not believe many patients became addicted to opioids also prescribed more opioids. [14] Furthermore, over 10% of GP’s were not confident in their skills prescribing opioids. [14]. Surveys of Australian physicians studying attitudes to the use of opioids are required. Regardless of the attitude of physicians towards opioid prescription, there remains a responsibility to manage patients’ pain effectively. It is well recognised that this poses an ethical dilemma to the treating physician and involves a careful balance of risk and benefit. [9, 44] Several guidelines are available to clinicians to increase their confidence in prescribing opiate analgesics, including the RACP [45] and Hunter New England guidelines. [46]

Conclusion

It is apparent that individuals with highest risk of iatrogenic dependence will possess a constellation of risk factors. A combination of young age, depression, psychotropic medications and pain impairment combined with  substance  use  history  predicted  greatest  increased  risk  for opioid dependence. [4] However, methods for screening risk remain unreliable, compounded by a lack of universal guidelines to guide practice. In addition, high dose, chronicity, monitoring systems and physician attitudes may also increase the risk of dependence in the population. Thus far, Australian studies into opioid use have described trends in prescribing practices. Studies examining risk factors for iatrogenic opioid dependence represent a significant gap in the knowledge. Further research is likely to help guide clinicians to make better-informed decisions around opioid prescribing.

Acknowledgements

None.

Conflict of interest

None declared.

Correspondence

H Hartman: hannah.hartman@my.jcu.edu.au

References

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[17] Larance B, Degenhardt L, Lintzeris N, Winstock A, Mattick R. Definitions related to the use of pharmaceutical opioids: Extramedical use, diversion, non-adherence and aberrant medication-related behaviours. Drug Alcohol Rev. 2011;30(3):236-45.

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[24] Edlund MJ, Martin BC, Devries A, Fan M-Y, Braden JB, Sullivan MD. Trends in use of opioids for chronic non-cancer pain among individuals with mental health and substance use disorders: the TROUP study. Clin J Pain. 2010;26(1):1-8.

[25] Sullivan MD, Edlund MJ, Zhang L, Unützer J, Wells KB. Association between mental health disorders, problem drug use, and regular prescription opioid use. Arch Intern Med. 2006;166(19):2087-93.

[26] Liebschutz JM, Saitz R, Weiss RD, Averbuch T, Schwartz S, Meltzer EC, et al. Clinical factors associated with prescription drug use disorder in urban primary care patients with chronic pain. J Pain. 2010;11(11):1047-55.

[27]  Cicero  TJ,  Lynskey  M,  Todorov  A,  Inciardi  JA,  Surratt  HL.  Co-morbid  pain  and psychopathology in males and females admitted to treatment for opioid analgesic abuse. Pain. 2008;139(1):127-35.

[28] Zale EL, Dorfman ML, Hooten WM, Warner DO, Zvolensky MJ, Ditre JW. Tobacco smoking, nicotine dependence, and patterns of prescription opioid misuse: results from a nationally representative sample. Nicotine Tob Res. 2014 Oct 25.

[29] Layton D, Osborne V, Al-Shukri M, Shakir SAW. Indicators of drug-seeking aberrant behaviours: the feasibility of use in observational post-marketing cohort studies for risk management. Drug Safety. 2014;37(8):639-50.

[30] Australian Institute of Health and Welfare. 2007 National Drug Strategy Household Survery: detailed findings Canberra AIHW, 2008.

[31] Kalso E, Allan L, Dellemijn PL, Faura CC, Ilias WK, Jensen TS, et al. Recommendations for using opioids in chronic non-cancer pain. Eur J Pain. 2003;7(5):381-6.

[32] Mackesy-Amiti ME, Donenberg GR, Ouellet LJ. Prescription opioid misuse and mental health among young injection drug users. Am J Drug Alcohol Abuse. 2015;41(1):100-6.

[33] Meier A, Lambert-Harris C, McGovern MP, Xie H, An M, McLeman B. Co-occurring prescription opioid use problems and posttraumatic stress disorder symptom severity. Am J Drug Alcohol Abuse. 2014;40(4):304-11.

[34] Harrison CM, Charles J, Henderson J, Britt H. Opioid prescribing in Australian general practice. Med J Aust. 2012;196(6):380-1.

[35] Chang Y-P, Compton P. Management of chronic pain with chronic opioid therapy in

patients with substance use disorders. Addict Sci Clin Pract. 2013;8(1):21.

[36]  Fredheim  OMS,  Mahic  M,  Skurtveit  S,  Dale  O,  Romundstad  P,  Borchgrevink  PC. Chronic  pain  and  use  of  opioids:  A  population-based pharmacoepidemiological  study from the Norwegian Prescription Database and the Nord-Trøndelag Health Study. PAIN®. 2014;155(7):1213-21.

[37]  Compton  P,  Charuvastra  VC,  Kintaudi  K,  Ling  W.  Pain  responses  in  methadone- maintained opioid abusers. J Pain Symptom Manage. 2000;20(4):237-45.

[38] Raffa RB, Pergolizzi JV. Opioid-induced hyperalgesia: is it clinically relevant for the treatment of pain patients? Pain Manag Nurs. 2013;14(3):e67-e83.

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Categories
Review Articles

Double gloving in the operating theatre: The benefits and the potential drawbacks

There are potential benefits and drawbacks when double gloving in the operating theatre. Working in the operating room is associated with a high risk of contact with bodily fluids. To prevent breaches of surgical gloves in theatre it has been suggested in the literature that using two pairs of gloves (double gloving) could provide benefit.  Double  gloving  reduces  the  amount  of  contact  with the patient’s blood and is also effective at reducing the level of exposure to infectious material during needle stick injury. Double gloving also reduces the risk of perforation compared to single gloving. However, it is suggested that double gloving may actually compromise manual dexterity, tactile sensitivity and 2-point discrimination. In conclusion, double gloving does provide greater protection  against  infection  transmission  than  ‘single  gloving’ in relation to intraoperative glove perforation and needle stick injuries, and does not appear to compromise surgical performance.

Introduction06

Working in the operating room is associated with a high risk of contact with bodily fluids, especially for surgeons. [1] Transmission of an infection from a patient to a surgeon or other operating room staff occurs through mucocutaneous or percutaneous transmission, such as a needle stick injury. [2] Transmission of blood borne viruses such as hepatitis B (HBV), hepatitis C (HCV) and human immunodeficiency virus (HIV) are of particular concern to the occupational health and safety of surgical staff. Infection transmission from the surgical team to the patient may also be of concern. [3] For these reasons it is important to have measures in place for infection control. Use of intact surgical gloves is one way of preventing the transmission of these infections. However, breached gloves allow potential exposure to infectious material, especially if there are cuts or abrasions present. Breached gloves not only indicate potential for mucocutaneous transmission but also promote the possible inoculation of blood from a needle stick injury. [1]

To prevent breaches of surgical gloves in theatre it has been suggested in the literature that using two pairs of gloves (double gloving) is effective in reducing transmission of infection to surgeons and operating room staff. Double gloving is thought to be superior to ‘single gloving’ as it has a greater resistance to withstand breaches and perforation, lowering the probability of puncture. [1] Furthermore, double gloving is also understood to provide a lower dose of inoculated infectious fluid during needle stick injuries. [2]

This article will examine whether ‘double gloving provides greater protection against infection transmission than single gloving during intraoperative glove perforation and needle stick injury’.

Why surgeons double glove

Double gloving reduces the amount of contact with the patient’s blood. Blood borne infection may be transferred when bodily fluids and blood are transferred between the surgical staff and a patient, exacerbated by pre-existing cuts or abrasions already present on the skin. One study revealed that pre-operatively, 17.4% of surgeons had skin abrasions on their hands. [1] Furthermore, 38-50% of practicing surgeons may not be adequately immunised against HBV to prevent infection. [13] It has been estimated in a study that double gloving reduced the rate of blood contamination of the hands from 13% in the single glove group to 2% in the double glove group. [14]

Double gloving is also effective at reducing the level of exposure to infectious material during a needle stick injury. The risk of acquiring an infection from percutaneous exposure after a needle stick injury is 0.3-0.4% for HIV, 6-30% for HBV and 3-10% for HCV. [9] The volume of bodily fluid transferred by the needle itself in a needle stick injury is a predictor of the possibility of infection, with lower volumes providing a  lower  viral  load.  [10]  A  recent  study  used  double  gloving  and single gloving techniques of the same collective thickness and glove material to determine the amount of contaminate transmitted during simulated needle stick injuries. The results supported that the double gloving technique provides greater protection, with lower levels of contaminate transmitted through the needle stick injury. [2] Hence, double gloving is likely to be effective at reducing the level exposure to contaminate on a needle and consequently may reduce the incidence of transmission of infection to surgical staff. Therefore double gloving reduces the exposure of infectious contaminate on a needle stick during an injury, and may help prevent establishment of an infection, improving occupational health and safety.

The risk of perforation when double gloving is lower than the risk of perforation compared to single gloving. Intact gloves prevent the transmission of infection and therefore are important in the control of infection and safety. An analysis of gloves post-operatively found that 20.8% of surgeons who had single gloved had perforations and exposure to potentially infectious material, but only 2.5% of surgeons that double gloved had tears in the inner and outer glove. [11] A systematic review, including 31 controlled trials, reported that there were significantly more perforations of the single glove than the innermost (closest to skin) of the double gloves (OR 4.10, 95% CI 3.30 – 5.09). [12] Additionally, using an indicator glove (coloured latex underneath a second glove) warns the surgical team of any perforations and allows a replacement of the outer glove, which reduces the probability of tearing both layers and exposure to infectious contaminate. [12] Therefore double gloving protects the surgical staff and the patient from any exposure to potentially infectious contaminate and improves occupational health in the operating room

Why surgeons may not double glove

On the contrary, it has been claimed that the use of ‘double gloving’ may  actually  compromise  manual  dexterity,  tactile  sensitivity  and 2-point discrimination of the surgeon, therefore reducing the ability and quality of the surgeon’s performance. [3] Another problem may be that a decrease of manual dexterity may increase the rate of needle stick injuries. Additionally there is poor acceptance among surgeons to double glove including a regular habit of single gloving, comfort, and low risk of transmission. Furthermore, some choose not to double glove because they feel there is a lack of evidence supporting its protection. [5]

Double gloving diminishes the hand sensibility and moving two-point discrimination of surgeons compared to single gloving, both of these being important for a surgeon to perform to the highest standards. Studies have demonstrated that double gloving does indeed have an effect on hand sensibility when evaluating pressure sensitivity, when compared to a single glove and no glove. Furthermore double gloving was found to impair moving two-point discrimination, but not static two-point discrimination, when compared to single gloving. [6] For this reason some surgeons prefer not to use two pairs of gloves as it can affect their surgical performance in the operating room.

Double  gloving  does  not  appear  to  reduce  manual  dexterity.  Of note, many surgeons that advocate single gloving argue that their dexterity decreases with fatigue. Manual dexterity is defined as the ability to move fingers skilfully, manipulate small objects rapidly and accurately. Some surgeons are also concerned that manual dexterity will be compromised if employing a double glove technique during an operation, and consequently may result in poor performance. However this has been challenged in the literature, which suggests there is no difference in dexterity whether single or double gloving techniques are employed. One study examined the knot tying abilities of individual surgeons wearing one and two layers of gloves and found that there was no statistically significant difference between them. [7] Another study found that there was no substantial impact on manual dexterity, measured by a Perdue Peg-board, in double, single and no glove groups. [3] Therefore the use of double gloving as protection does not impair the quality of the surgeon’s performance.

Double gloving does not increase the risk of injuries such as needle stick injuries. A decrease in the level of tactile sensibility and manual dexterity of the surgeon is thought to increase the frequency of needle stick injuries in theatre. However as stated previously, manual dexterity is not compromised by double gloving. Furthermore, a study found that there was no correlation with the frequency of actual injuries and glove perforations compared to the number of glove layers. [8] Double gloving is no more of a risk to injury than single gloving; hence there are no grounds for it to be an occupational hazard.

Double gloving is not universally accepted by surgeons due to a lack of information and misconceptions. A questionnaire completed by surgeons revealed that most (57%) do not double glove, and that the most common reason not to was because of a perceived loss of manual dexterity. After competing the survey, the participating surgeons were given evidence-based information on the potential occupational health benefits of double gloving and only 23% said they would change their practice. [5] Hence, the majority of surgeons do not accept double gloving even with current evidence and may be at unnecessary risk of  infection  transmission  opportunity.  Various  surgical  specialties have different views on double gloving.  Orthopaedic surgeons almost universally utilise double gloving technique due to the inherent risks of mechanical injury, [5] whereas plastic surgeons tend to have lower double gloving rates. [5] Furthermore the age of the surgeon appears to have an impact on double gloving rates with older surgeons often opting for single gloves.  Anecdotally most trainees now double glove.

Conclusion

In conclusion, ‘double gloving’ provides greater protection against infection transmission than ‘single gloving’ in relation to intraoperative glove perforation and needle stick injuries. The prevention of infection transmission between surgical staff and patients is an important aspect of the occupational health and safety of the operating room. There is clear evidence that double gloving reduces post-operative wound infection.  In fact this is much more effective than a 5-minute hand wash. However, it is also important to consider the performance of the surgical team with double gloves. Although manual dexterity is not compromised, hand sensibility and moving 2-point discrimination may be impaired whilst double gloving. Furthermore, even when presented with strong evidence for its beneficial use in practice, surgeons still prefer not to double glove. In summary, there is considerable literature that suggests the use of double gloving reduces the probability of infection transmission in the operating room, and because infection is an occupational danger, it is recommended that surgical staff double glove while performing operations.

Acknowledgements

None.

Conflict of interest

None declared.

Correspondence

M Papageorgiou: papa0152@uni.flinders.edu.au

References

[1] Thomas S, Agarwal M, Mehta G. Intraoperative glove perforation – single versus double gloving in protection against skin contamination. Postgrad Med J. 2001; 77: 458-460

[2] Din SU, Tidley MG. Needlestick fluid transmission through surgical gloves of the same thickness. Occup Med. 2013; 64: 39-44

[3] Fry DE, Harris EW, Kohnke EN, Twomey CL. Influence of Double-Gloving on Manual Dexterity and Tactile Sensation of Surgeons. J Am Coll Surg. 2010; 210(3): 325-330

[4]  Buergler  JM,  Kim  R,  Thisted  RA,  Cohn  SJ,  Lichtor  JL,  Roizen  MF.  Risk  of  Human Immunodeficiency   Virus   in   Surgeons,   Anaesthesiologists   and   Medical   Students. Anaesthesia & Analgesia. 1992; 75: 118-124

[5] St. Germine RL, Hanson JH, de Gara CJ. Double gloving and practice attitudes among surgeons. Am J Surg. 2003; 185: 141-145

[6] Novak CB, Patterson MM, Mackinnon SE. Evaluation of Hand Sensibility with Single and

Double Latex Gloves. Plast Reconstr Surg. 1999 Jan; 103(1): 128-131

[7] Webb JM, Pentlow BD. Double gloving and surgical technique. Ann R Coll Surg Engl. 1993; 75: 291-292

[8] Jensen SL. Double gloving – electrical resistance and surgeons’ resistance. J Lancet. 2000; 355: 514-515

[9] Patz JA, Jodrey D. Occupational Health in Surgery: Risks Extending Beyond The Operating

Room. ANZ J Surg. 1995; 65(9): 627-629

[10] Bennet NT, Howard RJ. Quantity of blood inoculated in a needle stick injury from suture needles. J Am Coll Surg. 1994; 178: 107-110

[11] Gani JS, Anseline PF, Bissett RL. Efficacy of double versus single gloving in protecting the operating team. ANZ J Surg. 1990; 60(3): 171-175

[12] Tanner J, Parkinson T. Double gloving to reduce surgical cross-infection. Cochrane Database of Syst Rev. 2009; Issue 3. Art. No. CD003087

[13]  Barie  PS,  Dellinger  EP,  Dougherty  SH,  Fink  MP.  Assessment  of  Hepatitis  B  Virus Immunization Status Among North American Surgeons. Arch Surg. 1994 Jan; 129(1): 27-32

[14] Naver LPS, Gottrup F. Incidence of glove perforations in gastrointestinal surgery ad the protective effects of double gloves: a prospective, randomised controlled study. Eur J Surg 2000 May; 166(4): 293-295

Categories
Editorials

Educating tomorrow’s global health leaders

05One of the six key priority areas identified by The United Nations Global Strategy for Women’s and Children’s Health is to develop ‘stronger health systems with sufficient skilled health workers at their core’. [1] Such skilled workers   require   an   awareness   of   global health issues in order to meet the challenges inherent in future practice in the modern globalised world. Early exposure to global health experiences as a medical student is important in promoting future global health leadership, and can also help to optimise practice in the local community.

There has been a burgeoning interest in global health amongst medical students. [2] Today’s medical students are increasingly aware of global health issues and feel a strong sense of responsibility towards the global community. This can be attributed to numerous factors, including  the  media,  which  has  forged  a sense of an interconnected global society, and the rise of challenges that do not recognise geographic borders, such as climate change and the spread of infectious diseases. [3-5] This  has  emphasised  that  global  issues  are far less remote than they might have once seemed.

For medical students to make meaningful change in the global health arena, they require skills that may extend beyond those taught by traditional medical curricula. The attributes of a global health leader, according to Rowson et al., include being ‘globalised’, ‘humanised’, and ‘policy-orientated’. [6] Increasing  globalisation  demands  that doctors are culturally sensitive and address determinants of health at global as well as local levels.   Overseas medical experiences can encourage ‘globalised’ thinking, for example  by  encouraging  flexibility  as students witness alternative models of care guided by different cultural values. [7] One of the most important driving forces behind students’ commitment towards contributing to  developing  world  health  is  altruism, which underlies practice as a ‘humanitarian’ doctor. Humanitarianism makes participation in  global  health  rewarding  for  many,  and can foster a lifelong commitment to global health action and leadership. Another less well-recognised  attribute  of  global  leaders is the understanding that doctors can have a   substantial   impact   not   only   through treating individual patients, but also through policy-making  at  a  population  level.  A  key way Australian health professionals have helped in developing countries has been by advocating in partnership with local leaders to effect change.  For example, the TraumAid International organisation established by Dr Jennifer Dawson equips local leaders to run programs in the community on how to deal with trauma experiences. [8] Closer to home, there have been striking examples of doctors utilising their political voices to protect vulnerable populations, such as through advocacy for the rights of asylum seekers. [5,9]

The skills learnt overseas benefit students by not only encouraging them to be global health leaders, but also to be effective doctors back home. Students have reported enhanced clinical and communication skills, lateral thinking, personal awareness and enthusiasm towards training following overseas elective experiences. [10] They are also more likely to seek to serve underprivileged populations, including   in   rural   and   remote   Australia. [11]   Experience   in   low-resource   settings can also help graduates to be more aware of the impact of their clinical decisions. For example, the principles of the rational use of investigations learnt in developing countries can be transferred back to local settings to promote cost-effective practice by minimising the over-ordering of tests in favour of astute clinical assessment. [10]

A number of initiatives have arisen to meet the growing interest of Australian medical students in global health. Largely student- driven,   these   include   the   annual   AMSA Global Health Conference and the formation of university global health interest groups which operate within the AMSA Global Health Network. [4] Being part of a global health group encourages students to develop an early passion in global health and network with like-minded individuals to share ideas. [2] Global health groups have also taken leadership  in  piloting  education  programs that raise awareness of current global health issues. Encouragingly, these programs attract not only medical students, but also students completing a variety of courses at university and even the general public, as has been our experience with the global course facilitated by   the  Medical   Students’  Aid   Project  at UNSW. This underscores a key reality in global health, that solutions in the developing world often require partnership between medical professionals and those outside the medical sphere.

A popular way in which students gain practical experience in global health is through arranging electives in developing countries. The benefits of such electives are numerous. It is important to note, however, that electives can  be  associated  with  potential  harm  to both the student and the local community. Risks include lack of supervision which can lead   to   students   assuming   roles   beyond their capabilities, which can compromise patient care. [7] Trainees may also experience physical harm due to unstable environments or psychological impacts which can be exacerbated  by  limited  support  networks. [7] The potential harm to local communities can include disruption to local practices and disincentives  to  governments  to  invest  in local workforces. It is well-recognised that initiating long-term, continuous partnerships with communities are more effective in optimising health outcomes compared with short-term, “bandaid-approach” medical missions. [3] Further strategies to reduce risks and  promote  ethical  practice are  discussed in guidelines, such as ‘A Guide to Working Abroad for Australian Medical Students and Junior Doctors’ by AMSA and the AMA. [12,13] These   resources   can   encourage   students to be mindful of their potential impact on communities.

It is clear that an awareness of global health is vital for preparing future doctors to meet diverse future health challenges. Although numerous   student-run   opportunities   exist for students to engage in global health, there has been a call to also integrate global health into the formal university curricula, with over 90% of students believing that global health should  be  a  component  of  medical  school programs.   [7,11]   This   could   complement overseas  medical  experiences  by  providing a conceptual framework of the global health environment,  which  can  be  reinforced  by practical experience.

In our ever-changing environment, it is vital that students and junior health professionals are  offered  all  of  the  opportunities  they require    to    lead    meaningful    change    in tomorrow’s world.

Acknowledgements

None.

Conflict of interest

None declared.

Correspondence

N Jain: n.jain@amsj.org

S Jain: s.jain@amsj.org

References

[1] Ki-Moon B. Global Strategy for Women’s and Children’s Health. The Partnership for Maternal, Newborn and Child Health, 2010.

[2] Leow J, Cheng D, Burkle Jr F. Doctors and global health: tips for medical students and junior doctors. Med J Aust. 2011;195(11):657-9.

[3] Panosian C, Coates TJ. The New Medical “Missionaries” —   Grooming   the   Next   Generation   of   Global   Health Workers. N Engl J Med 2006;354(17):1771-3.

[4]  Fox  G,  Thompson  J,  Bourke V,  Moloney  G.  Medical students, medical schools and international health. Med J Aust. 2007;187(9):536-9.

[5] Australian Medical Association. Speech to AMSA Global Health  Conference  2014  ‘Changing  Dynamics  in  Global Health Issues, priorities, and leadership’ by AMA President A/Prof Brian Owler’ [Internet]. Canberra ACT: Australian Medical Association; 2014 Sep 8 [cited 2015 30 June]. https://ama.com.au/media/speech-amsa-global-health- conference-2014].

[6] Rowson M, Smith A, Hughes R, Johnson O, Maini A, Martin S, et al. The evolution of global health teaching in   undergraduate   medical   curricula.   Global   Health. 2012;8:35-.

[7] Mitchell R, Jamieson J, Parker J, Hersch F, Wainer Z, Moodie A. Global health training and postgraduate medical education in  Australia:  the  case  for  greater  integration. Med J Aust. 2013;198(6):316-9.

[8] TraumAid International. TraumAid International 2015 [cited 2015 23 June]. Available from: http://www.traumaid.org/home.

[9] Talley N, Zwi K. Let the children go — advocacy for children in detention by the Royal Australasian College of Physicians. Med J Aust. 2015;202(11):555-7.

[10]  Bateman  C,  Baker  T,  Hoornenborg  E,  Ericsson  U. Bringing   global   issues   to   medical   teaching.   Lancet. 2001;358(9292):1539-42.

[11] Drain PK, Primack A, Hunt DD, Fawzi WW, Holmes KK, Gardner P. Global health in medical education: a call for more training and opportunities. Academic medicine : journal of the Association of American Medical Colleges. 2007;82(3):226-30.

[12]   Parker   J,   Mitchell   R,   Mansfield   S,   Jamieson   J, Humphreys D, Hersch F, et al. A Guide to Working Abroad for Australian Medical Students and Junior Doctors. Med J Aust. 2011;194(12):1-95.

[13]  Pinto  AD,  Upshur  REG.  Global  health  ethics  for students. Dev World Bioeth. 2009;9(1):1-10.

Categories
Editorials

Medical students and a career in pathology

04“Medicine is pathology” declares The Royal College of Pathologists of Australasia (RCPA) [1] – a motto that has driven many to delve into this esoteric medical discipline. The legendary Robbins and Cotran textbook elegantly summarises pathology as the study of disease. [2] However, the discipline entails more than just studying disease, since it is firmly integrated in modern medicine through the diagnosis, prognosis, investigation, and management of medical conditions.

The RCPA is responsible for training medical doctors, scientists, and dentists in pathology in Australasia. There are currently nine overarching disciplines that, perhaps unknowingly to medical students, have been covered at various times in medical school: anatomical pathology, chemical pathology, clinical pathology, forensic pathology, general pathology, genetic pathology, haematology, immunopathology, and microbiology. [3] Training to become a pathologist typically takes at least 13 years, including medical school.    Some    pathology    disciplines    can also be combined with internal medicine disciplines under the supervision of The Royal Australasian College of Physicians. Because pathologists  have  medical  training,  they work closely with both medical practitioners and scientists to provide answers and advice for patients’ diagnoses, investigations and management. In addition, as medicine becomes  more  personalised  and  predictive at the genetic and molecular levels, [4] pathology   will   play   a   more   prominent role in patient care.   Moreover, pathology laboratories  must  correspondingly adapt  to cater for the analyses of substantial amounts of data. [5] This makes a pathology career a dynamic, fast-paced and challenging area to study and work in.

However,   pathology   is   one   of   the   least popular choices for specialisation, with one survey of Australian trainees showing that only   approximately  3%  of   trainees  enter this discipline. [6] Another Australian study found that immunology, as a sub-specialty of pathology, was considered in the top three career choices of only 6% of surveyed final- year medical students. [7] But what makes pathology such an unpopular discipline amongst medical students?

There have been several reports in the literature looking at this very phenomenon. An early study found that medical students tend to regard pathology with less prestige than other disciplines. [8] Medical students also remarked that pathology was clinically invisible, it was a mere basic science with little clinical applications, and they highlighted negative stereotypes of pathologists, including being “introverts”. [9,10] Interestingly, there may be some unfortunate truth to the latter – at least at the student level. A number of studies using standardised psychometric tests found  that  students  who  were  interested in the hospital-based disciplines (including pathology) scored lower on sociability measures than other disciplines. [11,12]

However, the attractive lifestyle of pathologists appears to be a major advantage, and is well recognised by medical students. [9] But how significant is an attractive lifestyle in influencing one’s future career? The limited research suggests that it has become a more dominant   factor   over   the   years.   [13,14] An early study of United States medical students over a decade found an increasing proportion of the top academic medical students were entering a “controllable- lifestyle” career, including pathology. [15] Resneck has analysed this trend in medical specialty selection and found that this trend reflected a societal shift in people opting for work with more flexibility, and placing more emphasis on friends and family. [16] Thus it appears that external factors are becoming more prominent in dictating ultimate future careers.

Medical students’ intended careers are also influenced  by   their   own   expectations   of future practice, own clinical experiences, influences from peers and mentors, and the exclusion of other disciplines. [9] The impact of role models, too, has a dominating effect on influencing future careers. [17] This influence is certainly important in the field of pathology, where the discipline may not be such an obvious choice for students. [18] Although role models can be junior and senior doctors, the latter (especially consultants) tend to have a bigger influence on future careers, according to one survey of medical students. [19]

One author has even argued that medical schools have a duty to expose students to the field of pathology, since a survey of Canadian residents found many stated that they receive little pathology teaching as a student, and therefore had several misconceptions about the   discipline.   [20]   This   suggests   that   a way for engaging more students and junior doctors in pathology is adequate exposure to the field during medical school. This may be through a stronger emphasis on role models or mentors, or medical school societies that promote interest in the area. Teachers/ clinicians  may  also  foster  interest  through the encouragement of research, by supplying research projects for medical students. [21] As a fast-advancing medical discipline, pathology is an ideal area for students to engage in.

In conclusion, there appears to be a multitude of reasons why people enter or avoid pathology, ranging across internal to external influences. Although it may not be the most popular medical discipline, pathology offers practitioners a challenging career that is advancing quickly as the understanding of genetic, molecular and cellular aspects of medicine are unravelled. So medical students may create an informed evaluation, teachers or role models should ensure adequate exposure  of  this  discipline  during  medical school.

Acknowledgements

None.

Conflict of interest

None declared.

Correspondence

A YS Lee: a.lee@amsj.org

References

[1] The Royal College of Pathologists of Australasia. What is pathology? 2013 [cited 2015 21 Jun]. Available from: https://www.rcpa.edu.au/Prospective-Trainees/What-is- Pathology.

[2] Kumar V, Abbas AK, Aster JC. Robbins & Cotran Pathologic Basis of Disease. 9th ed. Philadelphia, United States: Elsevier; 2015.

[3]  The  Royal  College  of  Pathologists  of  Australasia. Disciplines 2013 [cited 2015 June]. Available from: https://www.rcpa.edu.au/Prospective-Trainees/Disciplines.

[4] Dietel M, Johrens K, Laffert M, Hummel M, Blaker H, Muller BM, et al. Predictive molecular pathology and its  role  in  targeted  cancer  therapy:  a  review  focussing  on clinical relevance. Cancer Gene Ther. 2013;20(4):211-21.

[5] Becich MJ. The role of the pathologist as tissue refiner and  data  miner:  the  impact  of  functional genomics  on the  modern  pathology  laboratory  and  the  critical  roles of pathology informatics and bioinformatics. Mol Diagn. 2000;5(4):287-99.

[6] Harris MG, Gavel PH, Young JR. Factors influencing the choice of specialty of Australian medical graduates. Med J Aust. 2005;183(6):295-300.

[7] Bansal AS. Medical students’ views on the teaching of immunology. Acad Med. 1997;72(8):662.

[8]  Furnham  AF.  Medical  students’  beliefs  about  nine different specialties. Br Med J. 1986;293(6562):1607-10.

[9] Hung T, Jarvis-Selinger S, Ford JC. Residency choices by graduating medical students: why not pathology? Hum Pathol. 2011;42(6):802-7.

[10] Alam A. How do medical students in their clinical years perceive basic sciences courses at King Saud University? Ann Saudi Med. 2011;31(1):58-61.

[11]  Hojat  M,  Zuckerman  M.  Personality  and  specialty interest in medical students. Med Teach. 2008;30(4):400-6.

[12]  Mehmood  SI,  Khan  MA,  Walsh  KM,  Borleffs  JCC. Personality   types   and   specialist   choices   in   medical students. Med Teach. 2013;35(1):63-8.

[13]  Dorsey  E,  Jarjoura  D,  Rutecki  GW.  Influence  of controllable lifestyle on recent trends in specialty choice by US medical students. JAMA. 2003;290(9):1173-8.

[14] Lambert EM, Holmboe ES. The relationship between specialty choice and gender of US medical students, 1990–2003. Acad Med. 2005;80(9):797-802.

[15] Schwartz RW, Jarecky RK, Strodel WE, Haley JV, Young B, Griffen WO, Jr. Controllable lifestyle: a new factor in career choice by medical students. Acad Med. 1989;64(10):606-9.

[16] Resneck JS Jr. The influence of controllable lifestyle on   medical   student  specialty  choice.  Virtual  Mentor. 2006;8(8):529-32.

[17] Wright S, Wong A, Newill C. The impact of role models on medical students. J Gen Intern Med. 1997;12(1):53-6.

[18] Vance RP. Role models in pathology. A new look at an old issue. Arch Pathol Lab Med. 1989;113(1):96-101.

[19] Sternszus R, Cruess S, Cruess R, Young M, Steinert Y. Residents as  role  models:  impact  on  undergraduate trainees. Acad Med. 2012;87(9):1282-7.

[20]  Ford  JC.  If  not,  why  not?  Reasons  why  Canadian postgraduate   trainees   chose—or   did   not   choose—to become pathologists. Hum Pathol. 2010;41(4):566-73.

[21]  Lawson  McLean  A,  Saunders  C,  Velu  PP,  Iredale  J, Hor K, Russell CD. Twelve tips for teachers to encourage student engagement in academic medicine. Med Teach. 2013;35(7):549-54.

Categories
Articles

Executive statement

THE AUSTRALIAN MEDICAL STUDENT JOURNAL was the brain-child of a group of UNSW medical students in 2010.

BORN OUT OF A PASSION TO RAISE UP THE NEXT GENERATION OF MEDICAL RESEARCHERS AND TO CHALLENGE THE FRONTIERS OF MEDICINE AND SCIENCE, OUR JOURNAL HAS SINCE GROWN INTO A LEADING NATIONWIDE STUDENT PUBLICATION WITH THOUSANDS OF FOLLOWERS.

This year marks the 5th  anniversary of this landmark journal. With it, we also embrace many exciting milestones and developments.

In January this year, our Facebook page following skyrocketed to 7,000 members, reflecting the continued expansion of our national readership. We have also revamped our e-newsletter, creating a vibrant new email publication with a distinctive focus on the wonders of the science behind medicine.

Our regular glossy publications, sent to all major medical campuses in Australia, are as vibrant as ever, with this issue showcasing winning entries from winners of the Australasian Students’ Surgical Conference (ASSC). Our hardworking Editor-in-Chief, Ms. Jessica  Chan,  has  also  brought  into  being an  exciting  new  section  of  our  magazine,

‘Debate’. In it, specialists present the case for and against hot-button medical ethico-legal issues du jour.

In  addition to  the  exciting new  changes  in our publications, we also warmly welcome new additions to our staff team, in particular Ms.  Karen Du,  who  has  taken the helm  in the   Internal   Department,   succeeding   Mr Chris Foerster as the new Internal Executive Director.   With   her   demonstrated   passion for medical research and experiences both here at home in Australia, as well as in the United States, we look forward to seeing her contributions with us in the journal.

As Mr. Chris Foerster moves on from his role in the AMSJ staff body to the Advisory Board and pursues his career interests both in Australia and overseas, we would also like to sincerely thank him on behalf of the staff body of the AMSJ for his incredible commitment to the journal and its vision to bring a love of medical research to medical students all around Australia. We wish him all the best with his future endeavours.

Ms. Grace Yeung, third-year medical student at Griffith University, who has had a passion for medical research since her high school days, also joins us as the continuing External Executive Director of the Australian Medical Student Journal from January this year. Her research interests include endocrinology, neuropsychiatry, auto-immunology and global politics. She succeeds Ms. Biyi Chen, who has now moved onto exciting new work openings and   commenced   her   medical   internship this  year. We also  thank  Ms.  Biyi Chen for her incredible work in the AMSJ here in the external department from 2012-2014 as previous External Director and Secretary and wish her well with her continuing journey.

Finally, we would also like to take this opportunity  to  thank  our  sponsors.  It  is only with their generous support that our publication continues to be widely available to students across the nation, providing medical  students  with  the  opportunity  to both publish their research in a high calibre journal as well as to keep up to date with the ground-breaking research work from other Australian students.

To  our  readers,  we  thank  you  again  for picking up another copy of the AMSJ. This issue’s prize pickings include original research into   management   of   clavicular   fractures, a discussion of gender imbalance in ADHD diagnosis,  the  psychology  of  hand  hygiene and much more.

Turn the page. A world filled with softly beeping cardiac monitors, the cool steel of scalpels, the spreading warmth of hot surgical lights, the hum of doctors at work and the quiet ticking of thinking minds awaits…

Happy reading!

Correspondence

G Yeung: g.yeung@amsj.org

K Du: k.du@amsj.org

Categories
Articles

Editor’s welcome: The Renaissance men and women of the future

01Welcome to a Volume 6 Issue 2 of the Australian   Medical   Student   Journal (AMSJ)! I  am proud  to  showcase the work of  talented  medical  students  and  to  keep our  readers  apprised  of  the  latest  medical research  and  news. The  following  review articles,   editorials,   feature   articles,   case reports and original research demonstrate the wide variety of medical student interests and expertise.

Medicine is both a science and an art. Medical students  are  required  to  be  Renaissance men  and  women,  mastering  not  only  the vast expanse of medical knowledge, but also the ability to listen to, empathise with and comfort our patients. As Stephanie Chapple explores in her feature article “Medical humanities and narrative medicine”, while the technical and scientific aspects of medicine are important, equally so is the development of a good approach to, and understanding of, the patient experience in a way that affirms fundamental respect for their personhood. This sympathy should also extend to our colleagues, particularly in relation to the problem of substance abuse among medical students, as discussed in the feature article by Lewis Fry. Truly, medicine is the art of applying scientific knowledge to provide healing and solace to our fellow human beings.

In  addition,  the  modern  practitioner  must be acutely aware of the moral dimensions of healthcare,  which  are  increasingly  complex as  our  scientific capabilities grow.  As  such, I  am  pleased  to  introduce  in  this  issue  a new section of the AMSJ: ‘Debate’, where a bioethical topic is disputed by two experts. For the inaugural Debate, Dr Hunt and Prof MacLeod – both highly experienced palliative care staff specialists – argue for and against the   legalisation   of   voluntary   euthanasia. AMSJ has also begun collaboration with the Australasian Surgical Students’ Conference, and I am delighted to publish the winning abstracts of their 2015 Research Competition.

As future medical practitioners, changes to the medical workforce are extremely relevant to us. The guest article from our partner, the Australian Medical Students’ Association (AMSA), discusses the new Curtin University medical school, and why AMSA believes this would only exacerbate, not alleviate, medical workforce problems.

On a more individual level, many of us have pondered our future career options. Read Adrian Lee’s editorial about the expanding role of pathology in medicine, and how this affects its desirability as a career. Meanwhile, Neeranjali  and   Swaranjali   Jain   discuss   in their editorial how global health benefits future  doctors  not  only  abroad,  but  also here at home in Australia. Alternatively, turn the page to Aditya Tedjaseputra’s feature article  on  becoming  a  haematologist,  and how the Australian system differs from that of the United Kingdom. As the practitioners of tomorrow, it is imperative that medical students start being informed of career pathways today.

The AMSJ is brought to you by huge teams of dedicated volunteers from every Australian medical school, who sacrifice hefty amounts of their time and attention. Especial thanks to David Jakabek, my Deputy Editor-in-Chief, and my team of Associate Editors, who ensured the following articles are of the highest standard. Thanks also to Matt Megens and Jesse  Ende  the  Senior  Proof  Readers,  and their team, who ran the tightest proof reading ship in AMSJ history, and to Jane Guan and Noel Chia the Print Publication Officers, who swiftly laid out this entire issue with cheer and aplomb.

During  the  production  of  this  issue,  I  had the privilege of working with two Internal Directors. Thanks to Mr Christopher Foerster, the outgoing Internal Director, your patience and vision for the AMSJ was inspiring. Thank you to Ms Karen Du, our incoming Internal Director, for your hard work. Along with Ms Grace Yeung, the External Director, I welcome you to the AMSJ family, and I am sure AMSJ will continue to thrive under your leadership. Finally, I would like to thank our readers, authors, peer reviewers and sponsors who make AMSJ possible.

On behalf of everyone at the AMSJ, I hope this issue leaves you captivated, enlightened and thoughtful, long after you have put down the journal!

Correspondence

J Chan: j.chan@amsj.org

Categories
Feature Articles

The role of general practice in cancer care

The incidence of cancer has risen in Australia and globally over the past few decades. Fortunately, advances in medicine have enabled cancer patients to live longer. We now have the means to provide better healthcare and support for this group of ‘survivors’. However, this situation also poses unique challenges to the healthcare system as resources are limited but healthcare professionals are required to do more. In recent years, there has been a call for an expansion of the role of general practitioners (GPs) in cancer care. Such a primary care-based approach allows GPs to pursue their interests in cancer management and enables diversification of healthcare resources. This article will attempt to examine how general practice can be involved in cancer care in Australia.

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Introduction

Cancer is a chronic disease on the global scale. In Australia, cancer accounts for approximately a quarter of all deaths. [1] By the age of 75, one in three males and one in four females will be expected to be diagnosed with cancer. [1] These figures may be attributed to higher population growth and an ageing population. [2] As patients are diagnosed earlier and receive better treatment, more cancer patients transit into survivorship. [3] Consequently, the immediate demands of cancer care extend beyond diagnosis and treatment and towards multi-disciplinary care, which focuses on providing support and improving the quality of life of patients. This article will briefly examine the factors influencing the involvement of primary care physicians in cancer care in Australia and reference initiatives implemented by other countries.

Patterns of cancer care and areas of GP involvement

Cancer management is complex and involves different healthcare providers. According to Norman et al., cancer care patterns may be sequential, parallel or shared. [4] In sequential care, patients are mainly cared for by oncology teams while parallel care requires general practice (GP) management of non-cancer problems. Shared care has the greatest GP involvement and requires joint management of cancer care by GP and oncology teams. GPs in Australia are mostly involved in screening and diagnosis of cancer and, eventually, referral to specialists who take over treatment and patient follow-up. GPs also play a role in managing the side effects of treatment as well as education (including prevention measures) of patients and their families. Depending on the treatment outcome, supportive or palliative care may also be provided by GPs.

In the future, it is expected that GPs will need to accept responsibilities outside their remit. This is due to a limited number of specialists in rural and remote areas and the need to diversify and expand the healthcare workforce. [5] Furthermore, health systems that include strong primary medical care were shown to be more efficient and have better health outcomes. [6] Therefore, there is a gradual move towards shared care models with GPs playing a central role alongside other healthcare providers. In this context, it will be important to understand the factors influencing the involvement of GPs in cancer care and how to maximize their involvement throughout the spectrum of cancer care.

Factors influencing GP involvement in cancer care

Location of GPs

The degree of involvement of GPs may depend on where they are based. [7] Out of necessity, GPs in rural and remote areas could be involved in coordination of cancer care and also some aspects of treatment (e.g. pre-chemotherapy checks) and follow-up of side effects. Conversely, GPs working in urban settings were more likely to refer patients upon diagnosis.

Studies have shown that indigenous Australians and other minority groups living in rural or remote areas have higher cancer mortality rates due to reduced access to healthcare. [8] GPs working in these settings could reduce this inequality through better prevention and diagnosis,  timely  referrals  as  well  as  treatment  of  co-morbidities- areas which are traditionally within the remit of primary care. [9] Although the cancer curriculum in Australian GP training focuses on these areas, it is estimated that GPs only encounter about four new cancer cases each year with cases exhibiting huge variability in cancer types and treatment requirements. [7] Such a scenario necessitates opportunities for GPs to improve their skills and experience through case-based learning and seminars. [7] Online learning modules offered by Cancer Australia are a good starting point but more effort will be required to promote these learning opportunities as GPs may not be aware of such resources. [7,10]

In recent years, the rise of telemedicine has provided an important tool in connecting rural GPs and specialists. This has enabled rural GPs to be more involved in cancer care as they can easily gain access to specialist knowledge. In Queensland, medical oncology services via videoconferencing were trialed and provided to remote and rural communities. [11] Satisfaction levels were high among both patients and rural health workers with such benefits as reduced time and money,  improved  communication between specialists  and  patients and greater access to specialist support by rural GPs. [11]

Communication pathways

Communication between GPs and hospital-based services is regarded as a major challenge facing general practice in Australia. The main form of communication from hospitals to GPs is the discharge summary and specialist letter with GPs receiving information mainly from  hospital  medical  officers.  [5]  The  variable  quality  and  poor

timeliness of information received has been shown to impede quality communication between GPs and hospitals. These factors were attributed to poor understandings of GP roles in cancer care and their information needs, as well as inexperience of medical officers. [5] It was found that hospital communications to GPs tend to omit social information about the patient. As cancer patients have been shown to be dependent on GPs for psychosocial support, the social needs of cancer patients may not be addressed adequately by GPs if poor communication persists. [1]

 

It was also shown that GPs preferred to receive a multi-disciplinary discharge summary containing input from all health professionals involved. [5] The creation of electronic health records may facilitate the  development  of  such  a  discharge  summary.  In  Canada,  the British Columbia (BC) e-health initiative allows authorized health professionals working in BC to access complete patient records when and where they were required. [12] This initiative was shown to reduce patient delays and costs to healthcare providers and patients and is a great demonstration of how improved communication via improved access to patient records may improve healthcare outcomes of cancer patients. Nonetheless, it is important that such electronic platforms are developed for and with healthcare practitioners to allow them to tackle the patient’s needs without being burdened by technology. [12]

Regular  meetings  may  also  improve  communication  between  GPs and specialists. Mitchell et al. suggested that GPs should be regularly involved in hospital-based multi-disciplinary team (MDT) meetings. [13] It is heartening that a national survey found that 84% of GPs would consider taking part in MDT meetings should the opportunity arise. [14] This suggests that formalization of MDT meetings is highly feasible. Cancer patients may benefit from the sharing of experiences between members of a formalized MDT team and this could be crucial to patients who suffer from low-incidence cancers where experience of the team matters and also to GPs, who would otherwise have little awareness about which specialists to approach for specific cancers. [13]

Remuneration and financial incentives

Inadequate remuneration may also deter GPs from accepting additional responsibilities.  A recent study found an increasing proportion of Australian GPs are not involved in palliative care (25%) as compared to previous rates of 5% and 8% in 1993 and 1998 respectively. [15] Poor remuneration in relation to the time and knowledge required for palliative care may be a deterring factor. There is currently no requirement for GPs to provide after-hour services for palliative care and some GPs also reflect that they are not confident enough to manage the technical and psychosocial aspects of palliative care. [15]

Financial incentives may be helpful as the workload of GPs has increased but their incomes have decreased relative to specialist incomes. [6] In the United Kingdom, the Gold Standards Framework for palliative care rewards GPs who are interested in palliative care and demonstrate quality care through regular meetings and maintenance of a patient register. [16] Such a scheme may attract GPs to be more involved in palliative care. In addition, to increase involvement of GPs in population-based screening programs, the current payment scheme in Australia should be revised to reward service not just based on service to symptomatic patients but also asymptomatic cancer patients who approach GPs for counseling and other psychosocial issues. [8]

Role of healthcare providers

The  roles  of  healthcare  providers  are  often  unclear.  Holmberg  et al. reported that while some people understand the role of GPs in cancer care, others felt that their roles were not stated explicitly in guidelines. [17] The varying perception of GP roles may hinder GPs from expressing their information needs and prevent their expanded involvement in treatment and follow-ups.  It has been shown that patients prefer to know who is in charge and parallel care may provide a clearer definition of GP and specialist roles. [18] Moreover, parallel care is not as demanding as shared care in terms of the level of communication required to facilitate coordination of cancer care and may therefore be favoured by both GPs and specialists. [18] While it is important to align patients’ perception with the preferences of healthcare providers, a parallel pattern of care may not be necessarily be the most effective. This explains why there is now a gradual move towards multi-disciplinary care based on shared care models, which was highlighted in Australia’s 2009 report on ‘A healthier future for all Australians’. [19]

A shared care model would require clarity of roles and a need to recognize and expand the role of primary care without compromising healthcare outcomes. Two randomized control trials in the United Kingdom (UK) and Canada showed that follow-up of breast cancer patients by GPs was as safe as follow-up by specialists while an Australian study showed no difference in recurrence rates of colorectal cancer patient after follow up by GPs or specialists. [20,21] These studies imply that GPs may undertake a greater role in the follow- up phase. Similarly, there may also be a growing role for GPs in the treatment phase,  in  terms of  management of toxicity episodes or pre-chemotherapy checks, as new oral chemotherapeutic agents are developed. [13]

Access  to  protocols  such  as  The  Cancer  institute  NSW  Standard Cancer Treatment Program (CI-SCaT) may allow GPs to manage cancer patients without requiring too much reliance on specialist expertise. [13] Similarly, GPs can access wiki-based clinical practice guidelines which are developed and constantly updated by Cancer Council Australia. [22] GPs based in rural/remote areas have been relying on generic clinical skills adapted to cancer care to manage cancer patients for years and supplementation of these skills by specialized cancer information may improve the feasibility and practicality of GP-based cancer management. [23]

GP preferences and input

While there is much potential for the expansion of GP roles, GP preferences and their input in cancer plans needs to be valued. GPs generally express interest in being involved in areas that are traditionally within their remit such as prevention, diagnosis, surveillance and psychological support but less than 50% of GPs expressed a desire to undertake coordination roles in treatment and supportive care. [7] These observations may reflect underlying structural and systemic constraints (e.g. workload and payment structures) that could only be addressed effectively at a governmental level. Conversely, as mentioned previously, GPs in rural/remote areas are already actively involved in coordination of cancer and psychological care and thus they may accept expanded roles more readily.

Ultimately, there needs to be a buildup of trust and confidence in GP capabilities and increased involvement of GPs in cancer control plans will  be  necessary.  Internationally,  the  UK  National  Health  Service (NHS) has involved GPs in its cancer plan since 2000. [1] Similarly, in Australia, GPs have been involved in the National Service Improvement Framework for Cancer while a scoping exercise undertaken by the National Cancer Control Initiative in 2004 has sought to identify areas of priority to support cancer care by primary healthcare providers. [1] A result of which was the Cancer Service Networks National Demonstration Program (CanNET) which was funded by the Australia government in seven states. It was conceived as a means of identifying opportunities to improve the organization and delivery of cancer care via MDTs and managed clinical networks (MCNs) so as to improve outcomes and reduce disparities in cancer survival rates across population groups. [24]

Lessons from CanNET

The evaluation of CanNET provided valuable insights into the provision of multi-disciplinary cancer care. For example, in addition to effective communication, it was found that networking events and activities were essential  to  building  up  professional  relationships  between healthcare providers. [24] Moreover, although GPs were willing to be involved in MDT sessions, engaging GPs was found to be difficult due to constraints imposed on general practice. [24] This suggests that while examining constraints on the specialist side is important and has been researched extensively, increased focus should also be placed on alleviating constraints on the GP side.

CanNET was also found to increase the work burden for healthcare providers. [24] This has prompted a re-think of healthcare providers’ roles to incorporate more flexibility.  A number of innovative roles are found overseas and could be trialed in various CanNET networks. For example, the Uniting Primary Care and Oncology Network (UPCON) in Manitoba advocated the use of medical leaders in the form of lead family physicians (FPs). [25] These lead FPs are primary care physicians within a practice who have an interest in cancer care and constantly engage in regular education programs and meetings jointly organized by oncologists and FPs. They disseminate useful information to colleagues and also play an advisory role by raising issues pertaining to primary care during meetings with oncologists and the Manitoba cancer agency. Besides occasionally accepting referrals, lead FPs did not have to perform difficult or unfamiliar tasks and they were remunerated according to their level of involvement. [25] This program managed to improve the partnership between GPs and other healthcare providers and could potentially fit into the Australian system.

Consistent with the theme of medical leadership, it was found that the introduction of continuing professional development (CPD) was effective in promoting local champions in some CanNET networks. CPD opportunities such as mentoring and clinical placements were received positively and more than half of the healthcare providers surveyed acknowledged that these activities helped increased their knowledge and skills and provided valuable networking opportunities. [24] Nonetheless, more work is required to address potential constraints such as workload and staff shortages. This again raises the importance of tele-oncology as a possible solution as essential oncology skills may be learnt during GP sit-ins with patients, therefore reducing the need for face-to-face attendance of workshops.

Looking to the future- the ideal oncology curriculum

The Oncology Education Committee of Cancer Council Australia has developed an ideal oncology curriculum for medical schools with the aim of equipping students with the knowledge, skills and attitude to provide quality care to cancer patients and their caregivers. This curriculum  has  been  reviewed  recently  to  include  more  emphasis on clinical experiences such as ‘observing all components of multi- disciplinary  cancer  care’.  [26]  These  changes  reflect  the  need  for future doctors who are able to work within a multi-disciplinary cancer care setting and who can understand the role of healthcare providers (including GPs) in different phases of a cancer patient’s journey. [26] Students who are interested in becoming GPs will need to be familiar with the specific needs and requirements of cancer patients as GPs are often the first point of call. Furthermore, students who take up the Medical Rural Bonded Scholarship Scheme (MRBS) and end up in rural settings will be expected to take up more responsibility than their urban counterparts. As such, changes in medical education may pave the way for changes in future medical practice.

Conclusion

Cancer management in Australia is gradually changing toward a shared care model with a focus on multi-disciplinary care. In this context, there is an increasing demand for GPs to expand their roles to relieve the pressure on other healthcare providers. Existing constraints that impede the involvement of GP will need to be addressed. These include issues pertaining to communication, remuneration, role clarity as well as GP preferences and input. A number of initiatives such as CanNET were implemented and has helped identify areas which could promote a greater role for general practice in cancer care. Overseas healthcare initiatives such as UPCON and the BC e-health initiative will also provide further valuable lessons in our search for solutions. Currently, tele-oncology appears to be a viable approach in improving rural GP involvement in cancer care and alleviating workload and staff shortages.

In conclusion, GPs have the capacity to provide quality cancer care alongside their specialist counterparts and it would be a more efficient use of healthcare resources to involve rather than neglect them. It is unlikely that specialist cancer care will be compromised as they form the core component of the actual treatment process whereas GPs are envisioned to take up coordinating as well as diagnosis and follow-up roles. As the roles of the GP can be flexible depending on preference and expertise, this is in itself advantageous as cancer care is no longer limited by the number of specialists. Specialist care may also be enhanced due to a more focused and individualized approach afforded by the less workload taken on by the specialists.

Acknowledgements

None.

Conflict of interest

None declared.

Correspondence

K Ho: koho2292@uni.sydney.edu.au

References

[1] McAvoy BR. General practitioners and cancer control. Med J Aust 2007; 187(2):115-7.

[2] Australian Institute of Health and Welfare, Australasian Association of Cancer Registries. Cancer in Australia 2001. AIHW Cancer Series No. 28. (AIHW Cat.No. CAN 23.) Canberra: AIHW, 2004.

[3] Phillips JL, Currow DC. Cancer as a chronic disease. Collegian 2010; 17(2):47-50.

[4] Norman A, Sisler J, Hack T, Harlos M. Family physicians and cancer care.Palliative care patients’ perspectives. Can Fam Physician 2001; 47:2009-16

[5] Rowlands S, Callen J, Westbrook J. Are general practioners getting the information they need from hospitals to manage their lung cancer patients? A qualitative exploration. HIMJ 2012; 41(2)4-13.

[6] Harris MF, Harris E. Facing the challenges: general practice in 2020. Med J Aust 2006; 185(2):122-4.

[7] Johnson CE, Lizama N, Garg N, Ghosh M, Emery J, Saunders C. Australian general practitioners’ preferences for managing the care of people diagnosed with cancer. Asia Pac J Clin Oncol 2012;doi: 10.1111/ajco.12047

[8] Jiwa M, Saunders CM, Thompson SC, Rosenwax LK, Sargant S, Khong EL, et al. Timely cancer diagnosis and management as a chronic condition: opportunities for primary care. Med J Aust 2008; 189(2):78-82.

[9] Campbell NC, Macleod U, Weller D. Primary care oncology: essential if high quality cancer care is to be achieved for all. Fam Pract 2002; 19(6):577-8.

[10] Cancer Australia. Cancer learning.  2011. Available from: http://www.cancerlearning.gov.au/.

[11] Sabesan S, Simcox K, Marr J. Medical oncology clinics through videoconferencing: an  acceptable  telehealth  model  for  rural  patients and  health  workers.  Intern  Med  J 2012;42(7):780-5.

[12] British Columbia eHealth Steering Committee. eHealth Strategic Framework. British Columbia Ministry of Health, Vancouver 2005.

[13] Mitchell, G. (2008). The role of the general practice in cancer care. Australian Family Physician 2008; 37(9):698-702.

[14] Australia Government: Cancer Australia. CanNET national evaluation (final report-phase  1).  2009.  Available  from:  http://canceraustralia.gov.au/publications-resources/cancer-australia-publications/cannet-national-evaluation-final-report-phase-1

[15] Rhee JJ, Zwar N, Vagholkar S, Dennis S, Broadbent AM, Mitchell G. Attitudes and barriers to involvement in palliative care by Australian urban general practitioners. J Palliat Med 2008; 11(7):980-5.

[16] Munday D, Mahmood K, Dale J, King N. Facilitating good processes in primary palliative care: does the Gold Standards Framework enable quality performance? Fam Pract 2007:1-9.

[17]  Holmberg,  L.  The  role  of  the  primary-care  physician  in  oncology care.  Primary healthcare and specialist cancer services. The Lancet Oncology 2005;6:121-122.

[18] Aubin M, Vezina L, Verreault R, Fillion L, HudonE, Lehmann F, et al. Family physician involvement in cancer care follow up: the experience of a cohort of patients with lung cancer. Ann Fam Med 2010; 8(6):526-32

[19]  National  Health  and  Hospitals  Reform  Commission.  A  Healthier  Future  for  All Australians  –  Final  Report  of  the  National Health  and  Hospitals  Reform  Commission. Canberra, 2009:107.

[20] Grunfeld E. Cancer survivorship: a challenge for primary care physicians. Br J Gen Pract 2005; 55(519):741-742

[21] Esterman A, Wattchow D, Pilotto L, Weller D, McGorm K,Hammett Z. Randomised controlled trial of general practitioner compared to surgical specialist follow up of patients with colorectal cancer. 2004. Paper presented at the GP & PHC Research Conference. http://www.phcris.org.au/conference/2004/index.php

[22] Cancer Council Australia. Cancer council Australia wiki platform. 2012. Available from: http://wiki.cancer.org.au/australia/Main_Page

[23] Mitchell GK, Burridge LH, Colquist SP, Love A. General practitioners’ perceptions of their role in cancer care and factors which influence this role. Health Soc Care Community 2012; 20(6):607-16.

[24] Australia Government: Cancer Australia. CanNET national evaluation (final report-phase  1).  2009.  Available  from:  http://canceraustralia.gov.au/publications-resources/cancer-australia-publications/cannet-national-evaluation-final-report-phase-1

[25] Sisler J, McCormack-Speak P. Bridging the gap between primary care and the cancer system: the UPCON network of CancerCare Manitoba. Cam Fam Physician 2009; 55(3):273-8.

[26]  Cancer  Council  Australia.  Ideal  oncology  curriculum  for  medical  schools.  2012. Available from: http://www.cancer.org.au/health-professionals/oncology-education/ideal-oncology-curriculum-for-medical-schools.html

Categories
Feature Articles

Ki-67: a review of utility in breast cancer

Ki-67 is a protein found in proliferating cells that is identifiable by immunohistochemistry (IHC).   Its prognostic and predictive value in breast cancer has been an area of avid research in recent literature and is increasingly shown to be of value.   Identifying the presence of Ki-67 protein is now an accepted technique to differentiate hormone receptor (HR)-positive breast malignancies, and as a marker of prognosis in these tumours.  It is also shown to  have  predictive  value  in  neoadjuvant  chemotherapy,  and post-neoadjuvant endocrine therapy.  Whilst it is not currently recommended as a routine investigation in the diagnosis of breast cancer, with standardisation of its methodology it has potential to become so.

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Introduction

Breast  cancer  is  the  most  frequent  cancer  of  women  (excluding non-melanoma skin cancer) in Australia.   Survival of breast cancer has improved significantly in recent decades, with five-year relative survival increasing from 72% in the mid-1980s to 89% by 2010. [1] Survival rates have improved as a result of developments in screening, treatment and also diagnosis.

It is currently an exciting era in diagnostic medicine, with rapidly increasing knowledge and research leading to increased availability of diagnostic techniques. Improved diagnostics are allowing us to classify tumours not only based on their anatomical location and pathological appearance,   but   also   by   molecular   and   genetic   typing.      This increasing complexity of diagnosis and subtyping is allowing for more individualised cancer treatments and better outcomes for patients. Immunohistochemistry is an area of diagnostics that has blossomed over the past two decades. One of the most frequent uses of diagnostic IHC is in breast pathology.  IHC techniques may have prognostic and predictive value, [2] and contribute to the trend towards targeted and bespoke therapies.  Numerous tests have now been developed and some have become a standard part of the diagnostic work-up, such as for oestrogen receptors (ER) and progesterone receptors (PR), and human epidermal growth factor receptor 2 (HER2).

Despite the improvements in diagnosis, there remains a group of patients whose risk of recurrence is indistinguishable based on current standard tests.  This leads to potential overtreatment of patients who would not benefit from therapy, and potential under treatment of those who would. [3] Other tests include multi-gene predictors and urokinase plasminogen activator testing that also have proven benefit as prognostic factors, and possibly have predictive value.   The Ki-67 protein is a marker of proliferation that has been known for over two decades and has been the subject of renewed study and reporting of late. However, its popularity and integration into practice has been somewhat controversial.

Ki-67 as a proliferation marker

Ki-67 is a unique protein that is found exclusively in proliferating cells. It is present in the nuclei of cells in the G1, S and G2 phases of cell division and peaks in mitosis. Cells in the G0 phase do not express Ki-67. It is present in all cells, both tumour and non-tumour, and its presence is a marker of growth fraction for a certain cell population. [4] Despite the numerous studies demonstrating its presence in proliferating cells, the exact role of Ki-67 in cell division is as yet unknown. [5] Ki-67 was first assessed for prognostic value in non-Hodgkin’s lymphoma, but is increasingly used in various malignancies, [4] most notably in breast cancer. It has now been proven that a higher fraction of stained nuclei is associated with worse prognosis, and healthy breast tissue exhibits low levels of Ki-67 (<3%). [6]

Counting mitoses, flow cytometry (for determining S-phase fraction), and IHC for Ki-67 are common techniques for determining growth fraction.  Flow cytometry is not recommended in prognostication due to difficulty with methodology. [7] Logically, counting mitoses and Ki-67 should correlate highly but clinical studies have shown that only 51% of high Ki-67 expressing breast tumours have a high mitotic index. [8] Ki-67 and the other proliferation markers, despite showing promise, are not recommended as a routine part of breast cancer workup currently. [3]

Ki-67 as a surrogate genetic marker

Ki-67 and mitotic rate are both considered markers of cell proliferation, however Ki-67 is considered a superior prognostic marker. [6] One reason it can be used for prognostication is that it may act as a surrogate for genetically different tumours.  Patients with ER-positive tumours, like other malignancies, are known to display a great variance in behaviour, including response to therapy. This occurs because tumours display a heterogeneous mix of gene expression grade index. [9] To improve prognostication and therapy recommendations, breast malignancies were genetically subclassed into five subtypes (luminal A, luminal B, HER2-enriched, basal-like, and normal breast-like). Of most interest is the differentiation between luminal A and luminal B, which (by one author’s definition) are both ER-positive and HER2-negative tumours but display contrasting behaviour. [10] Luminal B tumours typically have worse outcomes and demonstrate higher proliferation. Genetic typing showed certain genes (such as CCNB1, MK167, and MYBL2) have higher expression in luminal B tumours. [10] Given that genetic testing is expensive, and hence impractical, as a routine test in some settings, [8] Ki-67 can be used as a surrogate measure.  This phenomenon has been studied wherein the combined prognostic value (IHC4) of ER status, PR status, Ki-67, and HER2 was shown to be of similar prognostic value to a more expensive 21-gene test. [11] Very recent Australian data shows that when tumours are divided into luminal A and B with the use of Ki-67 “the 15-year breast cancer specific survival was 91.7% [and] 79.4%” respectively. [8] This confirms the clinical variation in these tumours. These figures were only in lymph node-negative breast cancer treated with breast-conserving surgery and postoperative radiotherapy.

Prognostic value

Ki-67 has been accepted to differentiate between luminal B and luminal A tumours without additional genetic testing. [12,13] The best cut-off score to differentiate ER-positive HER2-negative tumours is currently thought to be around 14%. At or above this figure, a tumour can be regarded as luminal B subtype and hence having a poorer prognosis. However Ki-67 is also associated with “younger age at diagnosis, higher grade, larger tumor size, positive lymph node involvement, and lymphovascular invasion.’ [10] This is echoed in other large preclinical trials. [14]

A high Ki-67 is also shown to be associated with poorer ten-year relapse-free survival and breast cancer specific survival. This has been demonstrated in node-positive tumours, node-negative tumours, those treated with tamoxifen as the only agent, and those who are treated with combination therapy of tamoxifen and a chemotherapeutic agent. [6,10] A large retrospective Australian study has confirmed that Ki-67 appears to have significant mortality prediction.  In their experience, a Ki-67 cut-off of 10% yielded the highest sensitivity and specificity, and at this level patient mortality rose from 3% in the low-Ki-67 group to 22%, and 15-year survival increased from 3% to 22%. Of note, this study did not differentiate luminal A and luminal B, and this did not exclude ER-negative tumours, nor-HER2-negative tumours, and so only looked at outcomes based on Ki-67.  Interestingly, all HER2-positive tumours were high-Ki-67 tumours.  The difference in the Ki-67 cut-off when compared with the 14% from previous trials is likely explained by the lack of inter-laboratory validation. The poorer 15-year survival of the high-Ki-67 tumours, compared with Pathmanathan’s [8] study, can be partially explained by the inclusion of HER2-positive tumours and triple negative tumours, which are known to have poorer prognosis.

Aleskandarany  et al. [15] in their larger study confirmed the variation between luminal tumour but also suggest that there is little prognostic value in Ki-67 in subcategorising HER2-positive and triple negative tumours[16].  Further, they revealed that “ [a high Ki-67 is] associated with premenopausal status, larger tumor size, definite vascular invasion, and lymph node involvement”, thus in non-luminal tumours may be selecting a patient group with other predictors of poor prognosis.

Ki-67 predictive value

Studies regarding the predictive value of the test are not yet as convincing as for prognostication, but continue to be an area of continued research and debate.

There are potential roles for Ki-67 in directing therapy in primary chemotherapy, neoadjuvant chemotherapy, neoadjuvant endocrine therapy, and in radiotherapy case selection. Chang et al. [17] suggested that tumours with a high Ki-67 are likely to respond more favourably to chemotherapeutic agents in the primary setting and that Ki-67 as a marker may be measured temporally during treatment to assess response.  This study, however, had a small sample size and a single therapeutic regime, making it difficult to adopt in clinical practice.

Viale, [18] in his large retrospective review, showed that Ki-67 did not predict the relative efficacy of neoadjuvant chemoendocrine therapy in node-negative hormone receptor (HR)-positive tumours. However, this does not imply that Ki-67 has no role in directing adjuvant chemotherapy in other groups of breast malignancy.   This has been further studied in a group of high risk breast malignancies by Denkert et al. [19]  Denkert’s group demonstrated that Ki-67 predicts response to neoadjuvant chemotherapy in HR-positive, HR-negative, HER2-negative, and triple negative groups.  It also shows an effect on disease free survival (DFS), and overall survival (OS) in HR-positive and HER-negative groups.  This study also reveals that Ki-67 percentage is a continuum and subsets may not be simply broken down into ‘high’ and ‘low’; rather, multiple cut-off points may be required for a single tumour type and a variation of cut points required based on the studied endpoint (e.g. DFS or pathological response) and different tumours. To achieve this, further trials recording information prospectively will be necessary.

Ellis studied Ki-67 in the neoadjuvant endocrine therapy setting, and reported that it has limited role in pre-treatment biopsies, but its post- neoadjuvant treatment value predicts relapse-free survival. [20]  Ellis suggests that when Ki-67 and ER status are combined post-surgery, a low value is correlated with low levels of relapse, and states that therapy beyond continuation of endocrine agent is likely unnecessary. In contrast, poor biomarker profile post-surgery is associated with significantly earlier relapse, more typical of ER-negative tumours; patients should be “offered all adjuvant treatments”. [20]

Ki-67 also has predictive value outside of HR-positive tumours. There is evidence showing that in HR-negative tumours, a Ki-67 >20% is a predictor for clinical and pathological response in the neoadjuvant setting with anthracycline-based chemotherapy. [21] It showed that patients with HR-negative status and Ki-67 >20% were much more likely to respond to their prescribed regime. However the authors did not give the absolute variation in response based on Ki-67, and did not test with a variety of agents or protocols to see if IHC could be used to recommend a particular agent.

Another role for Ki-67 in the neoadjuvant chemotherapy setting is in reviewing the response to therapy. A number of authors have shown that Ki-67 percentage often decreases after adjuvant therapies, and that  reduction may  correlate  with  pathological  response  and  DFS. [22] Dowsett and colleagues [23,24] measured Ki-67 both at baseline and two-week post-neoadjuvant endocrine therapy.  These authors suggest that the Ki-67 after two weeks of neoadjuvant therapy is of greater prognostic value than at baseline.  They hypothesised that a great change in Ki-67 should also be predictive of outcome, but the trial failed to show this.

Despite the scarcity of high-quality data the latest St Gallens consensus supports the use of Ki-67 in defining luminal B tumours and states, “For patients with luminal B (HER2-negative) disease, the majority of the panel considered chemotherapy to be indicated. Chemotherapy regimens for luminal B (HER2-negative) disease should generally contain anthracyclines and… taxanes”. [12]  This suggests that some groups have already adopted Ki-67 as a significant predictive factor in the management of HR-positive tumours.

Barriers to Ki-67 being used as a routine component of breast cancer workup

When Ki-67 staining is performed, nuclei display brown pigmentation. The area of greatest staining is used for counting, and the fraction of nuclei stained by the antibody is used to determine a percentage score. Ki-67 score is the first IHC marker that requires exact quantification to assess its benefit and there is currently no standardised methodology to do this. [25,26] This has led to a broad range of recommendations regarding the minimum number of cells analysed to accurately ascertain the percentage. [19] There are also many antibodies that are commercially available which may display subtle variances in result. [27] Further variations may also be seen based on the method of counting, i.e. computer aided versus human analysis. [28] The lack of a standard method to ascertain the percentage in a reproducible way combined with the other variances in techniques leads to inter/ intra operator and laboratory variances.  These have made it currently difficult to incorporate Ki-67 into routine use. [26]

Other IHC assays have been validated in the field of breast malignancies, such as for HER2, [29] and have led to more concrete recommendations. [12] Validation involves standardised recommendations for numerous factors including tissue handling, fixation, assay selection, comparison to standards, and ensuring inter and intra-laboratory concordance. [30] Further, this has been complimented by the development of HER2 in-situ hybridisation (ISH) to assess the underlying gene expression, which may be superior or complimentary. [30] These advancements are yet to be achieved in Ki-67 analysis. Validation and standardisation of Ki-67 in a similar way has been called for by many authors, and if achieved will increase confidence in results and may allow for it to be used as part of routine testing. [25]

Conclusion

The renewed interest in Ki-67 in breast malignancies has proved its prognostic value, particularly in subgrouping HR-positive HER2- negative breast cancers.   There is now increasing evidence to show that it may have a predictive role, with most evidence pointing to its role in both directing neoadjuvant chemotherapy and in assessing tumours  post-neoadjuvant  therapy  to  help  direct  further  adjuvant

therapy. Ki-67, along with other commonly used IHC assays and genetic testing are facilitating a move away from previously crude methods of treatment to increasingly tailored treatment solutions for our patients. Once standardised, Ki-67 may provide a cost-effective contribution to this trend.

Acknowledgements

None.

Conflict of interest

None declared.

Correspondence

K Parthasarathi: krishnanpartha@hotmail.com

References

[1] Cancer Australia. Breast cancer statistics [Internet]. 2013 Mar. 6 [cited 2013 Sep. 29];1–2. Available    from:    http://canceraustralia.gov.au/affected-cancer/cancer-types/breast-cancer/breast-cancer-statistics

[2] Bhargava R, Esposito NN, Dabbs DJ. Chapter 19 – Immunohistology of the breast. 3rd Elsevier Inc.; 2011.

[3] Patani N, Martin L-A, Dowsett M. Biomarkers for the clinical management of breast cancer: International perspective. Int J Cancer. 2013;133(1):1–13.

[4] Scholzen T, Gredes J. The Ki-67 protein: From the known and the unknown. J Cell Physiol. 2000;182:311–322.

[5]  Jalava  P,  Kuopio  T,  Juntti-Patinen  L,  Kotkansalo  T,  Kronqvist  P,  Collan  Y.  Ki67 immunohistochemistry:   A   valuable   marker   in   prognostication  but   with   a   risk   of misclassification: Proliferation subgroups formed based on Ki67 immunoreactivity and standardized mitotic index. Histopathology. 2006;48(6):674–682.

[6] Yerushalmi R, Woods R, Ravdin PM, Hayes MM, Gelmon KA. Ki67 in breast cancer: Prognostic and predictive potential. Lancet Oncol. 2010;11(2):174–183.

[7] van Diest PJ. Prognostic value of proliferation in invasive breast cancer: A review. J Clin Pathol. 2004;57(7):675–681.

[8] Pathmanathan N, Balleine RL, Jayasinghe UW, Bilinski KL, Provan PJ, Byth K, et al. The prognostic value of Ki67 in systemically untreated patients with node-negative breast cancer. J Clin Pathol. 2014;67(3):222–228.

[9] de Azambuja E, Cardoso F, de Castro G, Colozza M, Mano MS, Durbecq V, et al. Ki-67 as prognostic marker in early breast cancer: A meta-analysis of published studies involving 12 155 patients. Br J Cancer. 2007;96(10):1504–1513.

[10] Cheang MCU, Chia SK, Voduc D, Gao D, Leung S, Snider J, et al. Ki67 index, HER2 status,  and  prognosis  of  patients  with  Luminal  B  breast  cancer.  J  Natl  Cancer  Inst. 2009;101(10):736–750.

[11] Cuzick J, Dowsett M, Pineda S, Wale C, Salter J, Quinn E, et al. Prognostic value of a combined estrogen receptor, progesterone receptor, Ki-67, and human epidermal growth factor receptor 2 immunohistochemical score and comparison with the genomic health recurrence score in early breast cancer. J Clin Oncol. 2011;29(32):4273–4278.

[12] Goldhirsch A, Winer EP, Coates AS, Gelber RD, Piccart-Gebhart M, Thurlimann B, et al. Personalizing the treatment of women with early breast cancer: Highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2013. Ann Oncol. 2013;24(9):2206–2223.

[13] Goldhirsch A, Wood WC, Coates AS, Gelber RD, Thurlimann B, Senn HJ, et al. Strategies for  subtypes–dealing  with  the  diversity  of  breast  cancer:  Highlights  of  the  St  Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2011. Ann Oncol. 2011;22(8):1736–1747.

[14] Engels CC, Ruberta F, de Kruijf EM, van Pelt GW, Smit VTHBM, Liefers GJ, et al. The prognostic value of apoptotic and proliferative markers in breast cancer. Breast Cancer Res Treat. 2013;142(2):323–339.

[15] Aleskandarany MA, Green AR, Rakha EA, Mohammed RA, Elsheikh SE, Powe DG, et Growth fraction as a predictor of response to chemotherapy in node-negative breast cancer. Int J Cancer. 2010;:NA–NA.

[16] Aleskandarany MA, Green AR, Benhasouna AA, Barros FF, Neal K, Reis-Filho JS, et al. Prognostic value of proliferation assay in the luminal, HER2-positive, and triple-negative biologic classes of breast cancer. Breast Cancer Res. 2012;14(1):R3.

[17] Chang J, Ormerod M, Powles TJ, Allred DC, Ashley SE, Dowsett M. Apoptosis and proliferation as predictors of chemotherapy response in patients with breast carcinoma. Cancer. 2000;89(11):2145–2152.

[18]  Viale  G,  Regan  MM,  Mastropasqua  MG,  Maffini  F,  Maiorano  E,  Colleoni  M,  et Predictive value  of  tumor  Ki-67  expression  in  two  randomized  trials  of  adjuvant chemoendocrine therapy for node-negative breast cancer. J Natl Cancer Inst. 2008 Feb. 5;100(3):207–212.

[19] Denkert C, Loibl S, Muller BM, Eidtmann H, Schmitt WD, Eiermann W, et al. Ki67 levels  as  predictive  and  prognostic  parameters  in  pretherapeutic  breast  cancer  core biopsies:  A  translational  investigation  in  the  neoadjuvant  GeparTrio  trial.  Ann  Oncol. 2013;24(11):2786–2793.

[20] Ellis MJ, Tao Y, Luo J, A’Hern R, Evans DB, Bhatnagar AS, et al. Outcome prediction for estrogen receptor-positive breast cancer based on postneoadjuvant endocrine therapy tumor characteristics. J Natl Cancer Inst. 2008;100(19):1380–1388.

[21] Petit T, Wilt M, Velten M, Millon R, Rodier JF, Borel C, et al. Comparative value of tumour grade, hormonal receptors, Ki-67, HER-2 and topoisomerase II alpha status as predictive markers in breast cancer patients treated with neoadjuvant anthracycline-based chemotherapy. Eur J Cancer. 2004;40(2):205–211.

[22] Nishimura R, Osako T, Okumura Y, Hayashi M, Arima N. Clinical significance of Ki-67 in neoadjuvant chemotherapy for primary breast cancer as a predictor for chemosensitivity and for prognosis. Breast Cancer. 2010;17(4):269–275.

[23] Dowsett M, Smith IE, Ebbs SR, Dixon JM, Skene A, A’Hern R, et al. Prognostic value of Ki67 expression after short-term presurgical endocrine therapy for primary breast cancer. J Natl Cancer Inst. 2007;99(2):167–170.

[24] Dowsett M, Smith IE, Ebbs SR, Dixon JM, Skene A, Griffith C, et al. Short-term changes in  Ki-67  during  neoadjuvant  treatment  of  primary  breast  cancer  with  anastrozole  or tamoxifen alone or combined correlate with recurrence-free survival. Clin Cancer Res. 2005;11(2 Pt 2):951s–8s.

[25] Jonat W, Arnold N. Is the Ki-67 labelling index ready for clinical use? Ann Oncol. 2011;22(3):500–502.

[26] Dowsett M, Nielsen TO, A’Hern R, Bartlett J, Coombes RC, Cuzick J, et al. Assessment of Ki67 in breast cancer: Recommendations from the International Ki67 in Breast Cancer working group. J Natl Cancer Inst. 2011;103(22):1656–1664.

[27] Colozza M, Sidoni A, Piccart-Gebhart M. Value of Ki67 in breast cancer: The debate is still open. Lancet Oncol. 2010;11(5):414–415.

[28] Fasanella S, Leonardi E, Cantaloni C, Eccher C, Bazzanella I, Aldovini D, et al. Proliferative activity in human breast cancer: Ki-67 automated evaluation and the influence of different Ki-67 equivalent antibodies. Diagn Pathol. 2011;6 Suppl 1:S7.

[29] Wolff AC, Hammond MEH, Schwartz JN, Hagerty KL, Allred DC, Cote RJ, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. Arch Pathol Lab. Med. 2007;131(1):18–43.

[30] Hicks DG, Schiffhauer L. Standardized assessment of the HER2 status in breast cancer by immunohistochemistry. Lab Med. 2011;42(8):459–467.

Categories
Feature Articles

Managing complicated malaria in pregnancy: beating the odds

Malaria, especially falciparum malaria, has the potential to cause multi-organ failure and is a major cause of morbidity and mortality in pregnant women. It is defined by the World Health Organisation (WHO)  as  the  presence  of  asexual  parasitaemia  and  one  or more of the following manifestations: cerebral oedema; severe anaemia; renal failure; pulmonary oedema; adult respiratory distress syndrome (ARDS); disseminated intravascular coagulation (DIC); acidosis; hypotension or shock. [1] The pathophysiology underlying this disease will be discussed in this paper and will serve as a basis for outlining the importance of immediate supportive management and prompt administration of appropriate anti- malarial chemotherapy.

 

Introduction

Malaria is an infectious, tropical disease caused by parasitic protozoa of the species Plasmodium. The malaria parasites are transmitted via the bite of an infected female Anopheles mosquito (vector), the most virulent species being Plasmodium falciparum (P. falciparum). [2,3] Malaria in pregnancy is a major public health concern and contributes heavily to maternal and neonatal deaths worldwide. [3] In this article, the pathophysiology of P. falciparum malaria will be discussed to provide a background for the relevant management options and ethical decisions faced when treating pregnant women with complicated P. falciparum malaria.

v6_i1_a27aCase Presentation

History

A 22-year-old woman, Ms AP, was admitted to Colombo General Hospital with high-grade fever, tremors and confusion. A detailed history revealed that she was a married, small business owner from a rural, farming region located in a malaria endemic area in Sri Lanka. [2] Her medical history was clear of any clinically significant past or current illnesses. However, it was found that she was four weeks pregnant with her first child.

Findings

On examination, she was alert but appeared fatigued with visible jaundice. Her blood pressure was 110/60mmHg and she was tachypnoeic and tachycardic with a heart rate of 110bpm. Her temperature was 37.8oC, indicating a pyrexial illness and her oxygen saturation was 94% on room air. Further physical examination revealed scleral icterus and splenomegaly but was otherwise unremarkable with no elevated jugular venous pressure or signs of pulmonary oedema. Laboratory investigations revealed normocytic normochromic anaemia (haemoglobin (Hb) 90 g/L), thrombocytopenia (platelet count 100 x 109   cells/L) and hypoglycaemia (blood glucose 3 mmol/L). Ms AP’s liver function tests were also abnormal, with raised liver enzymes and increased total bilirubin (12 mmol/L). Importantly, her blood results showed stage 3 kidney failure, with increased serum urea (12mmol/L), creatinine (180mmol/L) and reduced glomerular filtration rate (36 ml/ min). While viral serology and bacterial culture were negative, thick and thin blood films for malaria revealed ringed trophozoites, typical of P. falciparum (Figure 1), and parasitemia with more than 6% infected erythrocytes. Based on the World Health Organisation (WHO) criteria for severe malaria and her above presentation, indicating major organ dysfunction and asexual parasitemia, Ms AP was diagnosed with complicated malaria.

v6_i1_a27c

 

Discussion

Effect of malaria in pregnancy

Infection of red blood cells by the asexual forms of P. falciparum and the involvement of inflammatory cytokines result in the prototypical clinical manifestations of malaria. [4] The initial paroxysm of P. falciparum malaria presents as non-specific ‘flu-like’ symptoms including malaise, headache, diarrhoea, myalgia and periodic fever every 48 hours. [4,5] These  symptoms  are  associated  with  an  immune  response  which is triggered when infected red blood cells (RBCs) rupture, releasing RBC remnants, parasitic antigens, and toxins into the bloodstream. [4,5] If untreated, this fairly un-alarming presentation can quickly progress to complicated malaria involving vital organ dysfunction. [4,5] In   pregnancy, complicated malaria is more common due to altered immune function.[5,6].Discussed below is the pathophysiology and supportive management of the major manifestations of complicated malaria in pregnant women.

Severe anaemia (Hb less than 80g/L) is a major manifestation of pregnant women with P. falciparum complicated malaria and has the potential to cause maternal circulatory collapse. This is due to additional demands of the growing foetus and the ability of P. falciparum to invade RBCs of all maturities. [6,7] Both chronic suppression of erythropoiesis by tumour necrosis factor alpha (TNF-α) and synchronous eruption of erythrocytic schizonts contribute to severe anaemia. [6,7] P. falciparum also derives energy via breakdown of haemoglobin, making infected RBCs more rigid and less able to navigate the micro-circulation. [6,7] This, along with alteration of non-infected RBC membranes, by addition of glycosylphosphatidylinositol (GPI), cause increased haemolysis and accelerated splenic clearance of RBCs. [6,8] Increased activity of the spleen manifests clinically as splenomegaly. [8] In pregnant women, like Ms AP, who present with severe anaemia, packed red cells are transfused when a safe blood supply is acquired. [9] However, blood transfusions should be used sparingly in resource poor areas where the risk of negative outcomes, such as incidental transfer of human immunodeficiency virus (HIV), is great. [9,10]

Cerebral malaria is an ominous sign in pregnant women and is a neurological syndrome characterised by altered consciousness (Glasgow Coma Scale ≥ 8) and uncontrolled, sub-clinical seizures. The precise mechanisms involved in the onset of this phenomenon remains unclear; however, localised perfusion defects, metabolic disturbances, and host immune responses all play a critical role. [11,12] Decreased localised perfusion is primarily due to microvascular changes. P. falciparum proteins, such as Plasmodium falciparum erythrocyte membrane protein 1 (PfEMP-1), form knobs on the surfaces of infected RBCs and bind to receptors such as intracellular adhesion molecule 1 (ICAM-1) on the endothelium. This ability to cyto-adhere to cells results in sequestration of infected RBCs in blood vessels, causing endothelial inflammation and obstruction. [7,11] Interestingly, in P. falciparum malaria, a phenomenon known as rosetting also occurs. [11,12] Here, PfEMP-1 on infected RBCs bind to glycosaminoglycan receptors on uninfected RBCs, causing aggregation. [11,12] This further slows microcirculatory flow, reducing perfusion and causing ischemia-induced functional deterioration in organs such as the brain. [9,10] Mechanical ventilation in conjunction with appropriate anti- malaria drugs may be life-saving; preventing fatal hypoxemia and organ failure. [13,14] Seizures and other complications of cerebral malaria are treated with anti-convulsants to protect against rapid neurologic deterioration. [13,14]

Hypoglycaemia is a common manifestation in pregnant women with complicated malaria and arises from increased anaerobic glycolysis when P.falciparum metabolises glucose to lactic acid for energy. [7,8] In addition, decreased hepatic gluconeogenesis and increased demands of a febrile illness contribute to lowered blood glucose levels. [7,8] Intravenous administration of 25-50% dextrose solution injection is standard treatment and benefits both mother and foetus. [9,10]

Hepatic and renal failure occurs in complicated malaria due to mechanical obstruction of blood vessels by infected erythrocytes and via immune-mediated destruction of cells. [15,16] Loss of function of these organs result in poor lactate clearance, which along with increased anaerobic glycolysis and parasitic lactate production, potentiate metabolic acidosis. [15,16] Ultimately, these changes can progress to respiratory and circulatory distress. [15,16] In conjunction with anti- malarial agents, the best supportive therapy is fluid resuscitation or if required, renal replacement therapy. [15-19] Caution should be taken when treating malaria-induced hypertension in pregnancy as excessive fluid resuscitation via intravenous (IV) saline could worsen pulmonary oedema, triggering respiratory failure. [18, 19]

ARDS is more common in pregnant women and can be precipitated by  pulmonary  oedema,  compensatory  metabolic  acidosis,  sepsis, and severe anaemia. [11] It stems primarily from increased vascular permeability due to ongoing inflammation, as well as reduced pulmonary micro-circulatory flow. [11,12] Mechanical ventilation is essential in patients with ARDS as it helps maintain positive expiratory pressure and oxygenation. [13, 14] In patients presenting with hypotension, secondary sepsis due to bacterial co-infection should be suspected. Appropriate bloods including blood cultures should be taken and immediate treatment with broad-spectrum antibiotics such as clindamycin commenced. [14,19]

Effect of malaria on the foetus

Foetal distress is a concern in complicated malaria. Sequestration of RBCs in the placenta, via the binding of PfEMP-1 to chondroitin sulphate A (CSA) on the syncytiotrophoblast, can cause placental insufficiency. This results in poor oxygen supply to the foetus and may cause miscarriage, premature labour, still birth, growth restriction, and low birth weight. [20,21] This phenomenon is more likely in primigravida patients, such as Ms AP, and is thought to be due to lack of a specific immune response to the unique placental variant surface antigens (VSA) expressed by placental parasites. This hypothesis is supported by a longitudinal study by Maubert et al. which showed that antibodies against CSA-binding parasites were present in 76.9% of multigravida women by 6 months compared to only 31.8% of primigravida women. [22]  In  addition,  severe  fever  and  hypoglycaemia  disrupts  normal fetal development, which may induce premature labour and cause intrauterine growth restriction. [20,21] Micro-trauma to the placenta also increases the risk of infected maternal erythrocytes crossing into foetal circulation. Inevitably, this has the potential to cause congenital malaria and adds to the burden of complicated malaria in pregnant women. [20,21] Evidently, promoting prompt and efficacious drug treatment of malaria is necessary to reduce the systemic impact of malarial hyperparasitemia and to reduce foetal distress and mortality. Furthermore, due to the risk of congenital malaria, placenta, cord blood and neonatal thick and thin blood films should be considered for detection of malaria at an early age. [23]

Anti-malarial drugs and pregnancy

According to the South East Asian Artesunate Malaria Trial (SEAQUAMAT) study, a multi-centred, randomised controlled trial in South East Asia, artemisinin derivatives such as parenteral artesunate are the drugs of choice in pregnant women with complicated malaria. [24] These drugs are superior to quinine which is associated with a narrow therapeutic window, hypotension, and hyperinsulinemic hypoglycaemia. [24] While quinine was the traditional drug of choice, it is now considered outdated and the drug artemenisin is currently used. [24,25] Artemisinin derivatives work by producing cytotoxic oxygen radicals within the parasite.[24] Unlike other anti-malarial drugs, such quinine and chloroquine, artesunate is toxic not only to mature schizont forms of P. falciparum but also to early ring stage endoerythrocytic  trophozoites.  [24,25]  Therefore,  they  work  faster to clear parasites from the blood, reducing complications linked with micro-vascular damage and parasite glucose consumption. [24-27] While relatively safe, these drugs have been associated with foetal anaemia and lowered bone density in early trials. [23-28] However, it is important to remember that in complicated malaria the mother is the priority as without her survival, foetal mortality is highly likely. Importantly, efficacy of above drugs in pregnancy should also be monitored as pregnancy appears to alter the efficacy of anti-malarial agents. [23]. Patients should be advised of the risk of recurrence and offered regular blood films throughout their pregnancy. [23]

v6_i1_a27b

Conclusion

Complicated malaria in pregnancy is a medical emergency and can result in death if not treated properly. Like in Ms AP’s case, prompt administration of parenteral artesunate in conjunction with general supportive therapy is required for the best chance of survival for both the mother and foetus. [29]

Acknowledgements

None.

Consent Declaration

Informed  consent  was  obtained  from  the  patient  in  regard  to publication of this article for educational purposes.

Conflict of interest

None declared.

Correspondence

P Adkari: prasadi.adikari@my.jcu.edu.au

References

[1] WHO. Severe falciparum malaria. World Health Organization, Communicable Diseases

Cluster. Trans R Soc Trop Med Hyg 2000;94(Suppl. 1):S1–90.

[2]  Rajakuruna  R,  Amerasinghe  P,  Galappaththy  G,  Konradsen  F,  Briets  O,  Alifrangis Current status of malaria and anti-malarial drug resistance in Sri Lanka. Cey. J. Sci 2008;37(1):15-22.

[3] Kumar A, Chery L, Biswas C, Dubhashi N, Dutta P, Kumar V. Malaria in south asia: prevalence and control. Acta Tropica 2012;121:246-255.

[4] Lyke K, Burges R, Cissoko Y, Sangare L, Dao M, Diarre I et al. Serum levels of the pro-inflammatory cytokines interleukin-1 beta (IL-1), IL-6, IL-8, IL-10, tumor necrosis factor alpha, and IL-12(p70) in Malian children with severe Plasmodium falciparum aalaria and matched uncomplicated malaria or healthy controls. American society of Microbiology 2004;72:5630-7.

[5] Clark I, Budd A, Alleva L, Cowden W. Human malarial disease: a consequence of inflammatory cytokine release. Malaria Journal 2006;5:2875-85.

[6] Buffet. P, Safeukui I, Deplaine G, Brousse V, Prendki V, Thellier M et al. The pathogenesis of Plasmodium falciparum malaria in humans: insights from splenic physiology. Journal of American Society of Haematology 2011;117:381-92.

[7] Cowman A, Crabb B. Invasion of red blood cells by malaria parasites. Cell 2006;124:755-66.

[8]  Dondorp  A,  Pongponratan  E,  White  N.  Reduced  microcirculatory flow  in  severe falciparum  malaria:  pathophysiology  and  electron microscopy pathology.  Acta Tropica 2005;89:309-17.

[9] Day N, Dondorp A. The management of patients with severe malaria. Am J Trop Med. 2007;77(6):29-35.

[10] Mishra SK, Mohanty S, Mohanty A, Das B. Management of severe and complicated malaria. ICMR 2006;52(4):281-7.

[11] Barfod L, Dalgaard M, Pleman S, Ofori M, Pleass R, Hvidd L. Evasion of immunity to Plasmodium falciparum malaria by IgM masking of protective IgG epitopes in infected erythrocyte surface-exposed PfEMP1. PNAS 2011;10:1073-1078.

[12] Chakravorty S, Hughes K, Craig A. Host response to cytoadherence in Plasmodium falciparum. Biochemical Society Transactions 2008;45:221-228.

[13]  Uneke  C.  Impact  of  Plasmodium  falciparum  malaria  on  pregnancy and  perinatal outcome in Sub-Saharan Africa. Yale J Biol Med 2007; 80:95-103.

[14] Tongo O, Orimadegun A, Akinynika O. Utilisation of malaria preventative measures during pregnancy and birth outcomes. BMC 2011;11:1471-1478.

[15] Das B. Renal failure in malaria. ICMR 2008;45:83-97.

[16] Patel D, Pradeep P, Surti M, Agarwal SB. Clinical Manifestations of Complicated Malaria. JIACM 2003; 4(4):323-33.

[17] Gillion R. Medical ethics: four principles plus attention to scope. BMJ 2003;309: 184.

[18] Whitty C, Edmonds S, Mutabingwa T. Malaria in pregnancy. BJOG 2005;112:1189-95.

[19] Nosten F, Ashely E. The detection and treatment of Plasmodium falciparum. JPGM

2004;50:35-39.

[20] Pasvol G. The treatment of complicated and severe malaria. BMB 2006;75:29-47.

[21] Maitland K, Marsh K. Pathophysiology of severe malaria in children. Acta Tropica 2004;90:131-40.

[22] Maubert B, Fievet N, Deloron P. Development of antibodies against chondroitin sulfate A adherent Plasmodium falciparum in pregnant women. Infec. Immun.1999;67(10):5367-71.

[23] Royal College of Obstetricians and Gynaecologists. The diagnosis and treatment of malaria in pregnancy. Greentop Guideline No. 54B. London: RCOG; 2010.

[24]  South  East  Asian  Artesunate  Malaria  Trial  group.  Artesunate  versus  qunine  for treatment  of  severe  falciparum  malaria:  a  randomised  trial.  The  Lancet  2005;366(9487):717-25.

[25] McGready R, Lee S, Wiladphaigern J, Ashely E, Rijken M, Boel M et al. Adverse effects of falciparum and vivax malaria and the safety of antimalarial treatment in early pregnancy: a population based study. Lancet 2012;12: 388-96.

[26]  McGready  R,  White  N,  Nosten  F.  Parasitological  efficacy  of  antimalarials  in  the treatment and prevention of falciparum malaria in pregnancy 1998-2009: a systematic review. BJOG 2011;118:123-35.

[27] McIntosh H, Olliaro P. Artermisinin derivatives for treating severe malaria. Cochrane Collaboration 2012;1:33-47.

[28] Adebisi S. The toxicity of artesunate on bone developments: the wistar rat animal model of malarial treatment. Journal of Parasitic Diseases 2008;4(1).

[29] Briand V, Cottrell G, Massougbodji A, Cot M. Intermittent preventative treatment for the prevention of malaria during pregnancy in high transmission areas. Malaria Journal 2007;6:160-6.

Categories
Feature Articles

Making the cut: a look at female genital mutilation

Female Genital Mutilation (FGM) is a procedure of historical, cultural and religious derivation that continues its practice worldwide, involving partial or total removal of the external female genitalia.   The stand of many international bodies, including the United Nations, is that it epitomises a violation of the human rights of girls and women. Australian state and territorial law prohibits and categorises FGM as a criminal offence, as do RANZCOG guidelines  for  medical  practitioners.  Reducing  the  practice  of FGM worldwide encompasses involvement in awareness and education programs at an individual and societal level, beginning with local communities, elders/leaders, young men and women, and traditional health practitioners. Approaching the request for FGM or reinfibulation in an Australian healthcare setting requires an understanding of the socio-cultural influences surrounding the practice and empathy towards the needs of the patient and their cultural identity. It also requires a comprehensive understanding of the myriad physical and psychological health risks posed by FGM.

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Introduction

The  continued  worldwide  practice  of  female  genital  mutilation (FGM) or traditionally, ‘circumcision’ is one that has sparked much controversy within the ethics of Western medicine. Is the centuries old socio-cultural ritual a violation of the rights of a woman or child hiding behind the label of ‘custom’? Or has the Western world perceived ‘degradation’ where there is only an exercising of free will that is perhaps  unfathomable  but  not  necessarily  unethical?  How  much of ‘free will’ is truly an expression of an individual’s autonomy? To what extent does culture impinge upon it? And how do we as health practitioners balance this societal commentary with the bioethical principles underlying medical practice? These are questions that have come to the forefront of the FGM debate and that will be examined here. Perhaps, one of the more overarching issues we should also ponder is this: are and should the principles of what is ‘ethical’ be derived from socio-cultural forces?

According to the World Health Organisation (WHO), female genital mutilation (FGM) comprises all procedures that involve partial or total removal of the external female genitalia, or other injury to the female genital organs for  non-medical  reasons.[1] The current position of the WHO is that ‘FGM is a violation of the human rights of girls and women’.[1]

The World Health Organisation (WHO) estimates 100-140 million women worldwide are affected by female genital mutilation.[1] 28 countries of Africa, as well as a few countries of Middle East and Asia have documented practice of FGM.[1] Of these, the four countries with highest prevalence are Somalia, Sudan, Guinea and Djibouti (>90% of women). 1] In Australia, there have been an increasing number of migrants from countries practising FGM, particular over the past decade.[2]

The current laws and guidelines surrounding FGM

Under NSW Law, FGM is prohibited; Section 45 of the 1900 NSW Crimes Act extensively covers prohibition of female genital mutilation. [3] In fact, in all jurisdictions of Australia (though covered exclusively by differing states and territories), FGM is considered a criminal offence. [3] Current Royal Australian and New Zealand College of Obstetricians and Gynaecologists’ (RANZCOG) guidelines strongly recommend that all health practitioners do not acquiesce to the requests for elective reinfibulation or indeed other forms of FGM.[2] The United Nations has, as of December 2012, passed a resolution banning the practice of FGM worldwide, as a violation of human rights and dignity.[1]

The arguments ‘for’ prohibition of FGM

In terms of establishing a perspective on the matter, the tone of the commentary to follow is ultimately averse to the practice of FGM. At the forefront of this argument are the adverse health effects. A study by Hosken et al showed that 83 percent of women who had undergone FGM would require medical attention at some point in their lives for a condition resulting from the procedure.[4] In terms of a statistical look at the associated health problems, according to a survey of 55 health providers in the Nyamira District of Kenya, 49.1% reported obstructed labour, dyspareunia, bleeding, urinary problems, and fear and anxiety. [5] The World Health Organisation (WHO) estimates that women who have undergone FGM are twice as likely to die during childbirth and are more likely to give birth to a stillborn child when compared to those women who have not undergone FGM.[1]

Central to the argument is that it confers no health benefit to a woman, and contrarily presents a myriad collection of damaging consequences upon one’s health. Proponents of prohibiting the practice, such as Toubia et al, suggest that non-therapeutically excising an otherwise functioning body  part  is  not  simply  abhorrent;  it  is  a  violation of the codes of medical practice and an obstruction to the bioethical principles of non-maleficence and beneficence.[6]

An important detail is that the procedure is often performed on children (a large proportion pre-pubertal), who by virtue of medical ethics are not able to provide informed consent. But what of consenting adults? Whilst it is difficult to ignore the requests made by consenting adults in a sterile, medical environment within the healthcare systems of the Western World, this could condone the practice worldwide.[6] In many instances FGM has (despite it being a social custom of historical derivation) signified the degradation of the rights and dignity of women internationally.[1,6,7] Many argue that if health practitioners do not perform the procedure in a safe sterile manner, women will seek infibulation/reinfibulation from an untrained and often medically unsafe source.[8] However, the underlying point remains that it is the responsibility of the medical profession to uphold certain ethical principles of beneficence, non-maleficence and justice that are violated by FGM. The harm minimisation of performing re-infibulation/ infibulation sterilely as opposed to at the hands of a non-medical entity is ultimately not outweighed by the consequences of condoning said practice and failing to reduce the practice worldwide.[6,7]

Elchalal et al, in Female Genital Mutilation: the peril remains, consolidated the views of Toubia et al, in elucidating that societies and countries that promote the practice of FGM should seek to empower their women (over time) and symbolise social acceptance and respectability in practices that do not confer such negative health risks and psychological trauma.[6,7] What must be highlighted is the importance placed on healthcare workers to utilise their position of trust and objectivity, when relaying the health risks associated with FGM to patients.[6,7]

The arguments ‘against’ prohibition of FGM

It is important that whilst being in support of eradicating FGM, one examines the counter arguments. Those who defend the practice, hold the value of social integration and cultural importance to the sense of identity held by many consenting adult women, in a higher regard. [8,9] Bronnit et al identifies the psychological health benefits that can be derived from compliance with the practice of FGM, as often outweighing the adverse health risks.[8] Defenders of FGM question the betterment of the cultural and ritualistic component of mental health as being a valid justification for performing FGM.[8,9]

Whilst many commentators also refuse to condone the practice on children, Bronnit states that in denying requests for reinfibulation/ infibulation to consenting adults, you risk retreating to the ‘archaic’ models of paternalism.[8] It is an interesting argument to consider here: what of the adult woman who, in full knowledge of the risks of the procedure, requests it as it holds importance to her cultural and personal identity? It is undeniably difficult to criticise the respect for patient autonomy.

In response to this argument, the facet of autonomy that can be questioned  in  these  scenarios  is  whether  the  request  for  FGM  is a product of cultural embedding. [1,2,5,6] This does not mean to demean the cultural background of the patient. It instead allows us to contemplate the possibility that what is desired by the patient is the sociocultural integration and acceptance FGM affords them.[1,2,5] There is anecdotal evidence in current literature to suggest that fear of rejection by family and community is a potent driving force in desiring FGM.[1,5] It is difficult to assess what component of the request is entrenched in a socio-cultural need for assimilation, and this could impede the voluntariness of consent. It is important to assert that fear is no justification for condoning what is unquestionably a practice with harmful health consequences. The solution is not to acquiesce to pressure to perform FGM but to educate the community as to the risks and impacts of FGM.

Some commentators reinforce that if patient autonomy is stated to be an adequate justification for performing female cosmetic genital surgery, it should also apply as adequate justification for medically performed FGM.[8,9] Many advocates of similarly banning labioplasty argue that certain forms of cosmetic surgery on female genitalia pose similar health risks to FGM. [10] However, perhaps what this should invoke is a questioning of the ethical soundness of female genital cosmetic surgery. Despite said assertions that the legal permitting of labioplasty should likewise permit FGM, the converse can and must be argued. Performing one potentially unethical procedure should not allow the medical practice of other unethical procedures.

The final stance

It is of great interest in finally evaluating this argument, to return to a question posed at the beginning of this paper: should ethics be removed from socio-cultural standpoints?  The answer is yes, and herein lies the core opposition to the practice of FGM. Ethics are

grounded in the basic human rights and preservation of the dignity of a person. As E.H Kluge postulates in Female Genital Mutilation, Cultural Values and Ethics, ethics apply to the nature of what it is to be human, and consequently apply to all human beings irrespective of their background or belief system.[11] Therefore, if cultural frameworks fail to meet these universal standards, they can be subject to ethical critique.[11] Consequently despite having respect for the autonomy of the patient, this writer holds the opinion, as do several international bodies, that FGM has led to worldwide incidences of violations of the  rights  of  a  woman,  and  degradation  of  their  inherent  dignity and should be prohibited.[1] Also as health practitioners objectively upholding what is in the best health interests of the patient, we cannot ignore the high risks of varying adverse physical and psychological health outcomes that are often inevitable with FGM.[1,4,5]

Reducing the practice of FGM internationally

Legislation that is effective in countries condoning FGM is well and good, but how does one begin to turn a centuries old wheel? International organisations, such as UNICEF, have mapped out goals for eliminating FGM internationally.[12] These are mainly aimed at affecting change at an individual and societal level by challenging age-old customs. [12] Koso-Thomas et al found, in examining populations and countries that practice FGM, levels of education and literacy were inversely proportional to rates of FGM, so these are areas to be addressed in terms of empowering women to have the correct educational tools for informed decision making.[13] Community based interventions, which bring together leaders and elders of local communities as well as women and their families, are one method. They can permit open discourse and awareness programs to take effect.[12,13] An intriguing concept in implementing strategies for change is that of decreasing the

‘supply and demand’ of FGM.[12] This involves educating target groups such as the local health practitioners carrying out the infibulations.[12] It encompasses educating them as to the dangers of FGM or retraining practitioners of traditional medicine in women’s health and midwifery, hence providing them with a more ethically suitable position.[12,13] Educating young men and their families is also vital in terms of reducing the stigma surrounding women who do not receive FGM.[12] This will assist in challenging the association of FGM with marriageability.[12]

Managing requests for FGM in medical practice

The views of Elchalal et al and RANZCOG guidelines still hold; cultural sensitivity and probing the cross cultural barrier is necessary in providing comprehensive healthcare whilst denying the request of FGM. [2,7] Extensive antenatal/gynaecological counselling may allow a  healthcare  practitioner to  not  only  build  rapport  and  trust,  but also allow one to elicit details of what influences requests for the procedure.[2] This therefore reduces adverse mental health outcomes that may arise from a refusal of the request. The inclusion of family members  (whilst  carefully  documenting  their  views),  is  not  only in keeping with the desire of the patient; it allows you the unique opportunity to hear their opinions, understand their influence on the patient, and   incorporate them into your educational strategies.[2] The guidelines have stressed the vital importance of treating women who have undergone FGM without ‘alarm or prejudice’, as allowing them the confidence to access healthcare is an imperative outcome of treatment.[2] Educational outreach programs, namely the National Education Program on Female Genital Mutilation and FARREP (Family and Reproductive Rights Education Program) utilise both multilingual and multicultural health workers who can assist in offering culturally sensitive healthcare.[2] Ultimately, it is important to uphold the quality of life of the patient and identify the factors that contribute to it.

Acknowledgements

Dr. Vicki Langendyk for providing vital feedback about this topic for students undertaking the Obstetrics and Gynaecology ethics curriculum at the University of Western Sydney School of Medicine.

 

Conflict of interest

None declared.

Correspondence

N Vigneswaran: nilanthy.vigneswaran@gmail.com

References

[1]   World Health Organisation (WHO). Female Genital Mutilation Fact Sheet [Internet]. 2014  [Updated  2014  Feb,  Cited  2014  Jul  19].  Available  from:  http://www.who.int/mediacentre/factsheets/fs241/en/.

[2] Gilbert, E. Female Genital Mutilation: Information for Australian Health Professionals. The Royal Australian College of Obstetricians and Gynaecologist. Victoria. 1997.

[3] Australasian Legal Information Institute (AustLII): NSW Consolidated Acts. NSW Crimes Act 1900: Section 45 [Internet]. 2014. [Updated 2014 Jun 13, cited 2014 Jul 18]. Available from: http://www.austlii.edu.au/au/legis/nsw/consol_act/ca190082/.

[4] Hosken, F. The Hosken Report: Genital and Sexual Mutilation of Females, fourth edition. Lexington, MA: Women’s International Network. 1997; pp. 48.

[5] Program for Appropriate Technology in Health (PATH) and Seventh Day Adventist-Rural Health Services. “Qualitative Research Report on Health Workers’ Knowledge and Attitudes About Female Circumcision in Nyamira District, Kenya”. Nairobi. 1996; pp. 83.

[6]  Toubia  N.  Female genital  mutilation and  the responsibility  of  reproductive health professionals. International Journal of Gynecology & Obstetrics. 1994; 46:127-135.

[7 ] El Chalal, U, Ben-Ami B, Gillis R, Brzezinski A. Ritualistic Female Genital Mutilation: Current Status and Future Outlook. Obstetrical & Gynecological Survey.1997;52(10):643–651.

[8] Bronnit, S. Female genital mutilation: Reflections on law, medicine and human rights. Health Care Analysis. 1998; 6 (1):39-45.doi:10.1007/bf02678079

[9] Berer, M. Labia reduction for non-therapeutic reasons vs. female genital mutilation: contradictions in law and practice in Britain. Reproductive health matters. 2010; 18(35);106-110. doi: http://dx.doi.org/10.1016/S0968-8080 (10)35506-6.

[10] Selvaratnam, N. Concerns over female genital cosmetic surgery. SBS News Australia [Internet]. 2013 Aug 26 [cited 2014 Jul 19];Health; [1 screen]. Available here from: http://www.sbs.com.au/news/article/2012/12/27/concerns-over-female-cosmetic-genital-surgery

[11] Kluge, E. Female circumcision: when medical ethics confronts cultural values. CMAJ. 1993;148(2):288–289.

[12] UNICEF Somalia. Eradication of female genital mutilation [Internet]. 2004. [Updated 2014  Feb,  cited  2014  Jul  28].  Available  here  from:  http://www.unicef.org/somalia/resources_11628.html

[13] Koso-Thomas, O. The circumcision of women: a strategy for eradication. London, England, Zed Books, 1987. p109.