Resistant hypercalcaemia in metastatic parathyroid carcinoma

We report a case of inoperable metastatic parathyroid carcinoma involving life-threatening hypercalcaemia that failed to respond to standard therapy. Our review of available therapeutic modalities showed a paucity of evidence to guide management of patients with these rare tumours. This is the first report of the treatment of malignant hypercalcaemia secondary to parathyroid carcinoma using denosumab.

Clinical record

A 45-year-old man with no significant past medical history presented with a fractured clavicle and evidence of a radiolucent lesion (brown tumour) within the clavicle on x-ray, characteristic for hyperparathyroidism (Box 1). On further investigation, biochemical analysis showing raised serum calcium and parathyroid hormone (PTH) levels confirmed primary hyperparathyroidism. A thyroid ultrasound showed a 39 × 29 × 32 mm mass in the right lobe, suggestive of a tumour. A staging computed tomography (CT) scan of the neck and chest and a bone scan showed bone changes consistent with hyperparathyroidism throughout the axial and appendicular skeleton. There was no evidence of metastatic disease.

The patient underwent a partial parathyroidectomy and right hemithyroidectomy. Histopathological examination confirmed parathyroid carcinoma. The tumour was invading the thyroid gland and there was evidence of lymphovascular invasion. After the operation, the patient developed persistent hypocalcaemia as a consequence of relative hypoparathyroidism. He had an ionised calcium level of 0.68 mmol/L (reference interval [RI], 1.12–1.32 mmol/L). He was diagnosed with hungry bone syndrome, a common problem following parathyroidectomy. This required treatment with high-dose oral calcium (5.4 g daily) and calcitriol (0.25 μg three times daily). Residual tumour was suspected, as his postoperative PTH level remained elevated, at 13.5 pmol/L (RI, 0.7–7.0 pmol/L). A whole-body sestamibi scan (Tc [technetium]-99m MIBI [methoxyisobutylisonitrile]-830MBq) did not confirm this. He remained under surveillance with 4-monthly clinical review with blood tests and annual sestamibi scans.

One year after his surgery, the patient’s PTH level had risen further, to 52.7 pmol/L. His calcium supplements were ceased, as he was hypercalcaemic (serum corrected calcium, 3.11 mmol/L; RI, 2.15–2.60 mmol/L). Despite ceasing supplementation, his hypercalcaemia worsened over 2 months, to a level of 4.15 mmol/L, with a PTH level of 203 pmol/L and creatinine level of 166 μmol/L (RI, 60–110 μmol/L). On clinical examination, he had two small palpable nodules in the right thyroid bed. A CT scan of the neck confirmed a 1.5 × 2.4 × 1.6 cm mass at the site of the previous surgery.

A positron emission tomography scan showed mildly increased fludeoxyglucose activity at the right thyroid bed, consistent with low-volume residual disease, and intense activity in the left retrocrural soft tissue (Box 2). Biopsy specimens were obtained from both sites and were found to be histologically consistent with parathyroid cancer. The patient underwent a planned resection of the known sites of disease, beginning with a right-sided neck dissection. Thereafter, he underwent a left thoracotomy, which showed more extensive pleural deposits and bulky metastatic disease over the diaphragm and crura, only amenable to debulking. A left pleural effusion, non-malignant on cytology, complicated his postoperative recovery.

After surgery, his PTH level remained elevated, at 112 pmol/L. His hypercalcaemia was difficult to manage despite using intravenous hydration and intravenous zoledronic acid (4 mg). His serum calcium level transiently fell from 3.14 mmol/L to 2.77 mmol/L. Cinacalcet 30 mg twice daily was commenced and titrated to a maximal dose of 90 mg four times daily, with no significant improvement in serum calcium levels.

Given the patient’s failure to respond to cinacalcet, in an attempt to reduce tumour size and function, he received two cycles of chemotherapy with a 3-weekly schedule of cyclophosphamide 500 mg/m2 on Day 1, 5-fluorouracil 500 mg/m2 daily on Days 1–4 and dacarbazine 200 mg/m2 on Days 1–4. On presentation for Cycle 2, his calcium level was 4.37 mmol/L and PTH level 335 pmol/L, indicating no biochemical response. He had symptomatic hypercalcaemia with fatigue, polydipsia, anorexia and renal dysfunction for management. He continued to receive weekly bisphosphonate infusions for management, but, despite this, his serum calcium levels did not fall below 3.0 mmol/L.

We trialled denosumab as a means of achieving control of the resistant hypercalcaemia. We used loading doses, aiming to bring about rapid blockade of receptor activator of nuclear factor kappa B (RANK) ligand. The schedule was taken from a Phase II study of giant-cell tumours of bone, in which loading doses of denosumab 120 mg were given subcutaneously on Days 1, 8 and 15, with monthly maintenance therapy thereafter.1 In our patient, after the initial loading dose, the serum-corrected calcium level dropped to 2.66 mmol/L by Day 8. After a second dose, by Day 15 his calcium level was normal, at 2.33 mmol/L. Calculated urinary N-telopeptide levels were monitored to test for suppression of bone turnover. The baseline level was 431 nmol bone collagen equivalents (BCE)/mmol creatinine (RI, < 65 nmol BCE/mmol creatinine); by Day 15 it fell to < 20 nmol BCE/mmol creatinine, indicating rapid suppression of bone turnover. After two loading doses of denosumab, the patient’s serum calcium remained within the normal range for 4 months. His creatinine level also decreased to 102 μmol/L. Further treatment with denosumab was to be guided by the serum calcium level.

Despite control of the calcium level, the patient’s disease progressed and his PTH level rose to a maximum of 433 pmol/L. He became symptomatic, with a recurrent pleural effusion, anorexia and weight loss. Owing to a paucity of data on effective chemotherapeutic agents, the case was discussed at a departmental case review meeting and a regimen of carboplatin and gemcitabine was suggested, given its broad activity and use in carcinoma of unknown primary site.2 The patient completed six cycles of treatment with relative stability of the pleural effusion and retrocrural disease; however, his PTH level did not decrease. His physical condition deteriorated over 6 months after completion of chemotherapy, and he required one further dose of denosumab for calcium control. The patient died 1 year after his presentation with metastatic disease.

Discussion

Parathyroid carcinoma is rare, accounting for less than 1% of cases of hyperparathyroidism. It is associated with a high rate of local and distant recurrence. The mainstay of treatment is surgical resection, even in metastatic disease. The disease is often refractory to medical management, leading to morbidity and mortality due to hypercalcaemia rather than metastatic disease; thus, an aggressive approach to resection has been advocated.3 Managing life-threatening hypercalcaemia and controlling a relatively indolent tumour pose a significant therapeutic challenge in inoperable disease.4

The efficacy of cinacalcet in the management of parathyroid cancer-related hypercalcaemia was assessed in an open-label single-arm study of 29 patients.5 Cinacalcet was commenced at 30 mg twice daily and titrated to 90 mg four times daily or until there was a response in the serum calcium. Over the 16-week study period, 62% of patients responded to therapy; the greatest response was seen in patients with the highest baseline calcium levels. PTH levels were also shown to decrease, but this was not clinically significant.

There is limited evidence for chemotherapy in the management of metastatic parathyroid carcinoma. Success using cyclophosphamide, 5-fluorouracil and dacarbazine has been reported, with normalisation of serum calcium and a complete response in pulmonary metastases after 12 cycles.6 There are several other case reports of agents that have demonstrated some efficacy, including dacarbazine as a single agent, the “MACC” regimen (methotrexate, adriamycin [doxorubicin], cyclophosphamide and CCNU [cyclonexyl-chloroethyl-nitrosourea, or lomustine]) and synthetic oestrogen therapy.4

Few strategies to manage resistant hypercalcaemia in parathyroid carcinoma have been published. One case report described immunisation using the bioactive section of PTH in a patient with resistant hypercalcaemia, with rapid improvement in symptoms and serum calcium. Autoantibodies to parathyroid hormone were identified in the patient’s serum within 4 weeks. The authors theorised that they prevented the binding of PTH to its receptors, thereby improving hypercalcaemia. There was no clinical or radiological evidence of tumour regression after 6 months of therapy.7

Denosumab is a fully human monoclonal IgG2 antibody that has a high affinity and specificity to bind RANK ligand, mimicking the effect of osteoprotegerin, which acts to competitively inhibit the binding of RANK ligand and RANK to inhibit osteoclast activation.8 Denosumab has been compared with zoledronic acid in the prevention of skeletal-related events, such as fractures, in patients with advanced malignancies in two randomised trials. In both, denosumab was associated with higher rates of hypocalcaemia and greater suppression of bone turnover markers.9,10 It is currently licensed in Australia for the treatment of osteoporosis and prevention of skeletal-related events in patients with metastatic breast and prostate cancer with bone metastases.

Preclinical data have shown that telomerase is active in parathyroid cancer cells and could be a potential therapeutic target. An in-vitro study of zidovudine, an antiretroviral agent, investigated its use in inhibiting telomerase. Zidovudine accumulated in malignant parathyroid cells in culture, which induced apoptosis. The effect was not observed in the adenomatous parathyroid cells, suggesting this could be considered as a targeted therapy.11 Studies in humans have not yet been done.

Metastatic parathyroid cancer is a rare malignancy that has a limited evidence base to guide management. We report a patient with refractory hypercalcaemia that dramatically responded to the RANK ligand inhibitor denosumab, with rapid suppression of bone turnover within days. Unlike bisphosphonates, denosumab does not require dose adjustment for renal impairment, which is common in patients with hypercalcaemia. Denosumab offered prolonged calcium control with less frequent administration. The management of parathyroid cancer remains a therapeutic challenge, owing to the minimal evidence for effective systemic therapy in patients with inoperable disease. We propose that denosumab should be considered in the treatment algorithm for patients with hypercalcaemia secondary to parathyroid cancer.

1 Plain x-ray showing brown tumour at the distal end of the left clavicle, characteristic of hyperparathyroidism

2 Positron emission tomography scan showing fludeoxyglucose avidity at the left retrocrural soft tissue, consistent with metastatic disease

In pursuit of surgical success

Ensuring a safe operation for every patient is not straightforward. Surgical patients range from the gravely ill with a slim chance of survival to the perfectly healthy who are seeking enhancement. Given this highly variable mix, surgical safety can be problematic to define, difficult to implement and harder to measure. As the population ages and technological advances feed public expectations, surgeons may feel at risk of finding themselves in the situation described over a century ago by then professor of surgery at the University of Edinburgh, John Chiene: “The operation was a complete success, but the patient died of something else”.

As several commentators in this issue indicate, there has recently been renewed focus on this enduring surgical dilemma. In an overview of the expanding field of perioperative care (doi: 10.5694/mja13.10383), Waxman describes the ideal scenario, in which elective patients benefit from multidisciplinary preoperative assessment and an “enhanced recovery after surgery” pathway. Preoperative planning and a “preflight” checklist in the operating theatre pay dividends for patients in their postoperative journey, even in emergency surgery.

With the aim of creating surgeons with a more holistic outlook, Australian standards of practice now include non-technical competencies including professionalism, communication, leadership and advocacy. Hollands, president of the Royal Australasian College of Surgeons (RACS), describes initiatives to ensure trainee surgeons are versed in these skills and to up-skill practising surgeons (doi: 10.5694/mja13.10384). He makes the important point that such efforts must be clinically relevant for them to have any impact.

The quality of surgical training is obviously relevant to patient safety. But could the training model itself, historically assumed to require full-time dedication, be an obstacle to acquiring the best possible surgeons? And how safe is full-time training for trainees? These questions arise from a survey of Australasian surgical trainees conducted by McDonald and colleagues (doi: 10.5694/mja12.11685). Only two of the 659 trainees surveyed had secured part-time accredited training positions, although a third of respondents expressed an interest in this model. The authors point out that this deficit in part-time training opportunities may result in applicants with family, personal or professional responsibilities and interests being filtered out of the training pool. Furthermore, the average working hours of full-time Australasian surgical trainees are at a level associated with burnout. In an accompanying commentary (doi: 10.5694/mja13.10341), Williams, censor-in-chief of the RACS, confirms at least one part-time accredited surgical training post in Australia has proven successful for both the hospital and the trainee. The RACS has now established a working party to look at extending opportunities for part-time training.

When the medical director of the United Kingdom’s National Health Service recently announced plans to publish a league table of mortality and “other” outcomes for British surgeons, the official response of the Royal College of Surgeons and the British Medical Association included a mild warning that uncorrected reporting of mortality rates may lead to an unwillingness of surgeons to take on high-risk cases. Informal commentators were more vocal, raising concerns about patient selection, impact on training, blame of individual surgeons for factors beyond their control, skewed statistics and the logistics of measuring performance (http://www.bjuinternational.com /bjui-blog/individualised-reporting-of-surgical-outcomes-in-the-uk). According to Maddern (doi: 10.5694/mja13.10344), public reporting is not yet planned for Australia, but the situation in the UK underscores the challenge for our own developing surgical audit systems of how best to determine, measure and feed back meaningful performance indicators to surgeons and their patients.

Waxman, Hollands and Maddern all present a common observation: it is patients who are driving the need for information, quality and assurances of safety. Undergoing surgery is certainly safer now than when Chiene made his ironic observation. But it remains true that, particularly from the patient’s perspective, there is no such thing as a successful operation with a poor outcome.

Public reporting of surgeons’ performance

Without comprehensive audit, it will remain difficult to highlight problems leading to poor surgical outcomes

In November 2012, the medical director of the United Kingdom National Health Service (NHS) announced that within 2 years, league tables showing performance data for surgeons working in the NHS in England would be published.1 The aim of this was to expose “variation and unacceptable practice” by publishing the results of “consultant-led” teams.2 While Australian national statistics in relation to diseases treated surgically (eg, cancer, trauma), associated complication rates, such as postsurgical infection, and mortality rates are generally as good as in comparable health systems, great improvements can still be made.3

However, the announcement from the UK has again raised concerns within the profession of the value and dangers of such audit programs. If reporting were introduced that focused purely on mortality then surgeons may avoid higher-risk patients. Risk adjustment of outcome can be conducted, but this is by no means a perfect science.4 Individual surgeons within hospitals or regions are often known for either excellent results or poor outcomes but, unless some form of measurement audit and feedback occurs, it is difficult to highlight problematic issues, such as poor surgical decisions or system failures, and improve patient outcomes. While mortality is a “hard” end point or outcome measure, it may not be the most important parameter to be measuring. Functional outcomes after joint replacement and tumour-free survival after bowel cancer surgery are examples of end points that may provide valuable feedback to surgeons, although they are rarely collected at present.

With regard to surgical audit in Australia, in 2005, the Royal Australasian College of Surgeons (RACS) became responsible for managing the Western Australian Audit of Surgical Mortality (WAASM), which had been established in 2001. The WAASM was modelled on the Scottish Audit of Surgical Mortality,5 which has operated successfully since 1988. The RACS has expanded the program to all states and territories, and since 2009, in conjunction with the state and territory jurisdictions, has carried out the Australian and New Zealand Audit of Surgical Mortality (ANZASM). According to the 2011 national audit, 99% of Australian public hospitals and 73% of private hospitals were participating in the audit.6

Private hospitals in New South Wales and Queensland have been slow to embrace the audit, but this is likely to be rectified over the next 12 months as funding issues are resolved.

The national audit provides feedback to surgeons on their cases, and institutes peer review of deaths by reference to the case notes of “concerning” cases in which mortality may not have been an expected outcome; for example, young patients or those in whom the management was open to question. The national annual reports for 2009–2011 allow thorough investigation of trends in areas such as deep vein thrombosis (DVT) prophylaxis, transfers, supervision and resuscitation, to name but a few.6

There are other surgical audits occurring independently. Many breast surgeons within Australia and New Zealand contribute to the National Breast Cancer Audit which enables them to compare their practice with peers.7 The Australian Orthopaedic Association, through its Joint Replacement Registry, has highlighted not only poor outcomes for certain prostheses but also a variety of outcomes obtained by different surgeons.8,9 Such data should be ideally available for other surgical procedures — for example, recurrence after hernia repair and cancer recurrence after bowel resection. However, these data are simply not available — surgeons rarely collect or report their results. It is not realistic or affordable to collect outcome data on all procedures. Nevertheless, “sentinel” procedures within specialties could be carefully monitored. The Australian and New Zealand Society for Vascular Surgery (ANZSVS) currently collects outcome data on carotid endarterectomy and has a protocol for detecting “outliers” by this approach.10 To date, there have been no serious attempts in Australia to introduce public reporting of surgeon performance data.

So what have we learned so far and what should be the way forward for Australia with respect to monitoring surgical performance?

The ANZASM has demonstrated to surgeons, from local rather than overseas experience, the value of adequate DVT prophylaxis, early patient transfer and careful resuscitation.

Careful review of all deaths should continue to be supported. More refined audits of outcome need to be established and the results provided to surgeons. Non-participants should not be allowed to maintain registration. With our national medical board registration, such sanctions are now possible and should be used for those not prepared to report on their results. Hospitals should insist on participation in such activities. The loss of even a busy surgeon with poor outcomes is a small price to pay for any public or private hospital.

There are lessons to be learned from over a decade of experience in WA since establishment of the WAASM. Better care and less enthusiasm for futile surgery appear to be leading to a real reduction in surgical mortality.

Finally, patients can ask or, indeed, insist that their surgeon participates in audit of their practice and should be more demanding in expecting results of the surgeons they visit. They should ask how the surgeon’s results are assessed, who does the assessment and how long they have engaged in such activities.11 If patients expect such information, government will need to help the profession to provide useful outcome data.

Real improvement in surgical care and performance is not really about picking the “outliers”, although this is an important benefit, but rather about improving the whole practice of surgery for the whole community.

Providing non-technical skills for surgeons

Can non-technical competencies be learnt in the context of a scientific conference?

In Australia and New Zealand, the learned medical colleges have substantial autonomy to determine standards for the practice of their discipline, and to educate medical specialists in their chosen specialty. Until 1996 most of the curriculum content was directed at the acquisition of medical knowledge and appropriate technical skills. In that year the Royal College of Physicians and Surgeons of Canada described an initiative to improve patient care.1 The CanMEDS competencies define the competencies needed for medical practice. While the core of this framework remained the medical expert, around this core were a further six competencies: the professional, the scholar, the communicator, the collaborator, the manager and the health advocate. The Royal Australasian College of Surgeons (RACS) has further developed these competencies to include technical expertise and judgement and clinical decision making.2 Leadership has been incorporated into management skills.

In Australia and New Zealand, trainee surgeons undertake the Surgical Education and Training (SET) program conducted by the RACS in partnership with specialist surgical societies. Trainees have a clearly defined curriculum that identifies goals and requires the successful completion of examinations demanding a command of all aspects of the curriculum. The specialist surgical societies have tended to focus their attention on teaching clinical knowledge and technical skills. There are a number of courses delivering non-technical skills. The college delivers NOTSS (Non-technical Skills for Surgeons) and TIPS (Training in Professional Skills),3 while the MOSES (Management of Surgical Emergencies) course has been developed by General Surgeons Australia.

The challenge facing the RACS is how to teach non-technical skills to practising surgeons. Many will not have been exposed to these non-technical competencies during training. To complicate matters further, many surgeons feel they already have these skills in abundance or believe them to be irrelevant.

While there is a large corpus of literature on changing practice among medical practitioners, much of it is focused on family practice doctors. Moreover, most of the literature is directed at changing clinical behaviour rather than teaching non-technical skills. The literature provides a number of educational models, but none of them is ideal. Models focusing on group dynamics are difficult because of the large number of doctors needing exposure to these components, and the limitations on their time. Nonetheless, the RACS runs several courses, such as NOTSS, which are available for surgeons who wish to undertake this training.3 Running a series of courses for a large body of practising surgeons is difficult because of the infrastructure required, the restrictions around availability of pro-bono teachers and the vast number of courses needed.

Another way in which the RACS has dealt with this difficulty is by using the plenary sessions at its Annual Scientific Congress to address these issues. Being a college rather than specialist society meeting, the audience is large (about 1200 delegates) and eclectic, with a variety of surgical craft groups represented. Larger, well attended meetings allow for funding of international speakers and provide a platform for local experts. Further, attendance at a conference represents a significant component of a Fellow’s continuing professional development requirements.

Is this approach valid? A review of the RACS Annual Scientific Congress identified sufficient evidence that attending such a conference is worthwhile and may change practice.4 Conferences are made up of many component parts including didactic lectures, workshops, short papers, research and plenary sessions directed at a more general audience. Nonetheless, providing information alone may in itself not alter behaviour.

New information that is presented must be relevant to clinical practice. Clinicians then make changes to practice based on the perceived value of the new material. The presentation of this material by experts appears to help, but such experts of course are not always good educators. When planning a conference, it is essential to identify a clear set of educational objectives, based on a needs assessment with a clear set of educational outcomes.5 Plenary sessions can be used in this fashion, namely with a clearly defined set of objectives, good educators and a focused educational outcome.

It remains to be seen, however, whether exposure to appropriate information about non-technical skills in a conference format works, and in due course the approach used by RACS will need to be evaluated. The community is demanding more comprehensive professionalism from clinicians. It is imperative that surgeons recognise its relevance to good clinical practice.

Smoothing out the ride for surgical patients

Bruce Waxman examines the drivers of change in perioperative care and the effects on patient outcomes

Whether a patient is having an elective or emergency procedure, ideally their journey will follow a pathway that has been mapped out from the time of entering the hospital until their discharge summary is generated.

Recent changes in perioperative patient management have been described as a “paradigm” shift in surgical care — from traditional models (largely dictated by individual surgeons or surgical units) to a multidisciplinary team approach (including planned protocols, policies and guidelines with accountability governed by audit and peer review, the outcomes of which are used to formulate recommendations that effect change).1 The driver is a synergy between a quest for improving quality and safety and the desire to be more efficient with diminishing resources — where the objective is to reduce patient morbidity and mortality.

Here, I outline an ideal model of care — although, even with the best intentions, pragmatic deviations can occur. While it is most relevant to Australia, similar models exist overseas.2

For patients who undergo elective procedures, the journey starts in the pre-admission clinics, which have been around for a couple of decades but are now better integrated. Today, pre-admission clinics combine pre-anaesthetic and presurgical assessments of risk with allied health and nursing interventions that commence the discharge planning process and allow day-of-surgery admissions. They also provide the opportunity to commence the most exciting intervention of the journey — the accelerated recovery pathways, or enhanced recovery after surgery (ERAS). ERAS programs have led to halving the 30-day morbidity and reducing the length of hospital stay by at least 2 days.2,3 The success of ERAS programs depends not only on a committed clinical team, but also on a well prepared and informed patient who has realistic expectations about standardised discharge criteria and planning, and has adequate social support. The programs use a combination of strategies, such as reducing nausea and vomiting with pre-emptive multimodal non-opioid analgesia (which allows the patient to tolerate three meals a day and promotes early return of gastrointestinal function) and judicious use of intravenous fluids. When increasing use of laparoscopic or minimally invasive surgery is added to the equation, the result is further reduction in length of stay, smaller incisions and fewer adhesions.2

When the patient arrives in the operating theatre, the World Health Organization’s Surgical Safety Checklist swings into action. Often referred to as “time out”, it uses a similar model to the preflight checklist used by airline pilots. The aim is to not only ensure the correct patient and the correct operative site, but also to ensure that the team members are familiar with each other, the objectives of the operation are clear to all and potential complications have been pre-empted — true crew resource management. In addition, the team checks and implements the plan for venous thromboembolism prophylaxis, if not already commenced before surgery, and commences the “bundle of care” to prevent surgical site infection. This bundle includes: maintaining normothermia and ensuring adequate oxygenation in the operating theatre, recovery room and ward; administering prophylactic antibiotics; monitoring and managing blood glucose levels; using drain tubes judiciously in patients with obesity; and preparing skin with a chlorhexidine-based agent. These initiatives have also led to better outcomes.2,4

Perioperative care continues in the ward, intensive care unit or high dependency unit. Patient outcomes are likely to be better if a perioperative medical service is in place which integrates well with the surgical team. Any deterioration is detected early and handled by the hospital acute response or medical emergency team. Regular multidisciplinary meetings with allied health professionals and the rehabilitation team drive early assessment and discharge through rehabilitation wards or programs such as hospital in the home. Communication and clinical handover are increasingly being managed with computer-based programs and electronic medical records, part of the e-health revolution, which enables online delivery of discharge summaries to general practitioners.

Similar principles apply to patients who undergo emergency surgery, although the planning cannot be so strategic. Introduction of the 4-hour rule in emergency departments and acute surgical units means that patients are seen by the surgical team within 2 hours of arrival and enter the operating theatre within 24 hours, leading to reduced length of stay and better outcomes. A driver of the acute surgical unit concept is the 12 point plan of General Surgeons Australia.5

These changes in perioperative care mean that patients will be well informed and well managed, and should have a smooth perioperative journey, rather than a “roller-coaster” ride.

Emergency surgery model improves outcomes for patients with acute cholecystitis

To the Editor: Reducing the time from presentation to cholecystectomy in patients with acute cholecystitis has been shown to benefit patients (eg, by reducing the duration of patient discomfort before surgery) and to be cost-effective.1–3 Benefits have also been shown for performing cholecystectomy during the index admission for gallstone pancreatitis.4

Geelong Hospital (in regional Victoria) introduced daily general surgery emergency theatre sessions in February 2011. We compared 401 patients who presented to the emergency department (ED) with acute cholecystitis from February 2008 to January 2011 (control period) with 137 who presented from February 2011 to January 2012 (intervention period). We also compared patients who presented with gallstone pancreatitis — 91 in the control period and 38 in the intervention period. For patients who underwent cholecystectomy during their index admission, we analysed the time of presentation to the ED and time of surgery. Complication rates (for bile duct injury, bile leak requiring intervention, unplanned endoscopic retrograde cholangiopancreatography, mortality or unplanned reoperation) were analysed by medical record review.

We found an increase in the proportion of patients with acute cholecystitis who had a cholecystectomy during their index admission, excluding those who were transferred to the private system, from 53% (199/373) to 72% (94/130) (P < 0.001). We also found a decrease in the median waiting time from patient arrival in the ED to operation for those with acute cholecystitis who had a cholecystectomy during their index admission, from 41.8 to 26.4 hours (P < 0.001). However, there was no significant difference in the complication rate for patients with acute cholecystitis who received a cholecystectomy in the control and intervention periods (P = 0.96).

Patients with gallstone pancreatitis underwent a cholecystectomy after their pancreatitis had settled. Of those who presented with gallstone pancreatitis in the control period, 42% (38/91) had their cholecystectomy during their index admission; this increased to 63% (24/38) in the intervention period (P = 0.03).

The proportion of cholecystectomies (for acute cholecystitis or gallstone pancreatitis) performed after-hours did not increase, despite an increase, from 51% to 70%, in patients receiving cholecystectomy during their index admission. Operations were performed in-hours for 73% (172/237) of those who underwent cholecystectomy during their index admission in the control period and 70% (83/118) of those who underwent cholecystectomy during their index admission in the intervention period (P = 0.15). For both of these groups, the median postoperative length of stay was 2 days (P = 0.67).

These data show that introducing dedicated general surgery emergency theatre sessions improved our ability to perform surgery in a timely manner for patients who presented with cholecystitis or gallstone pancreatitis.

Injuries to the head and face sustained while surfboard riding

To the Editor: Surfboard riding is an iconic pastime in Australia. Injuries to the head and face constitute a considerable proportion of surfing injuries;1–5 26% of acute surfing injuries are to the head and face, and these make up 42% of emergency department presentations by surfers.3

We conducted a retrospective review at our tertiary referral hospital of patients who underwent medical imaging for injuries sustained to the head and face while surfboard riding from January 2008 to January 2012. We searched the hospital radiology databases for patient records containing the terms “surfboard”, “surfer” or “surfing”. Patients were included if they were injured while surfboard riding and were excluded if they were injured during other water-based activities (eg, bodyboarding, kitesurfing, bodysurfing, paddleboarding). Twenty-nine patients were identified: 23 males and six females (mean age, 34 years; range, 10–73 years). Of the 26 who had acute injuries, 17 had imaging of the head only, seven had imaging of the head and cervical spine and two underwent a trauma protocol (computed tomography scans of the head, spine, chest and abdomen). Fifteen patients had been struck in the head by their own board, nine had other mechanisms of injury (primarily involving contact with the sea floor and associated neck pain), one collapsed while surfing and one was retrieved from the surf unconscious (mechanism of injury was unknown). The most common significant injuries were facial fractures (five of 26 patients, all of whom had been struck by their own board). One patient ruptured their left globe after being struck by their own board. No intracranial trauma (eg, intracranial haemorrhage, contusion) was identified.

Surfboard design and surfing accessories have evolved significantly over the past 20 years. Lighter, shorter boards are now commonly used and provide greater manoeuvrability in the water. Leg ropes are universally used to ensure that surfer and board do not become separated (Box). However, lighter boards and leg ropes might increase the risk of being struck and injured by one’s own board during a “wipe-out”. The pointed nose and fins on the undersurface of the board are also potentially injurious (Box).

Understanding injury mechanisms can drive surfboard and surfing accessory design to reduce the risk of injury and death. Protective devices — such as helmets, protective eyewear and nose guards that cover the tip of the surfboard — have been marketed, but there is no evidence of their effectiveness in injury reduction.

Innovations in surfboard design that are potentially injurious to the surfer

A: Leg rope. B: Pointed nose at the front of the board. C: Fins on the undersurface of the board (a three-fin design is the most common configuration on a modern shortboard).

Supply and demand mismatch for flexible (part-time) surgical training in Australasia

Surgical training follows an apprenticeship model, traditionally involving long hours of full-time mentored practice over several years. Recently, this model has been challenged by several trends, including working-hour restrictions, falling case exposure, and a desire for work–life balance.1–3 Another challenge is an increasing demand for flexible (part-time) training.4,5

The Royal Australasian College of Surgeons (RACS) supports flexible training by allowing trainees to accredit part-time work, but it mandates a time commitment of at least 50% during any training year.6 However, the opportunity to train part-time in surgery is also influenced by hospital employers and supervisors, and the supply of part-time surgical training posts is limited.

There are currently no data from our region regarding the number of surgical trainees undertaking flexible training. Our primary aim was therefore to define current flexible surgical training uptake and demand in Australia and New Zealand. A secondary aim was to identify demographic and work-related factors motivating interest in flexible training.

Methods

All 1191 trainees enrolled in an RACS program during 2010 were identified through the College’s database and invited by email to complete an anonymous online questionnaire, with weekly reminders over 4 weeks. Approval was granted by the RACS Ethics Committee.

The survey comprised four sections with option buttons. The first section defined demographic characteristics, including age, sex, specialty and Surgical Education and Training (SET) program year. Demographic data were also analysed to determine whether the responding sample was representative of all RACS trainees. The second section defined current working hours, and the third section rated work-related fatigue. Trainees were asked if they worked part-time, full-time or were not currently in active clinical training (ie, interrupted or deferred, such as for research or parenting). Results concerning trainee working hours and impacts of fatigue have been reported elsewhere.3,7 The fourth section used Likert scales to ascertain respondents’ perceptions of their work–life balance and interest in flexible training. This section included the question, “Are you interested in the option of applying for flexible (less than full time) training during your surgical training?”. Responses were assessed for differences between sexes and specialties. Further analyses were undertaken to identify whether interest in flexible training was correlated with working hours or fatigue.

Analyses were performed using SPSS version 19.0 (IBM), using cross tabulations with the χ2 test (threshold P < 0.05).

Results

Of the 1191 trainees, 659 responded (response rate, 55.3%), and 587 respondents (89.1%) completed all relevant questions. Respondents were similar to all trainees in terms of specialty (P = 0.22) and sex (P = 0.09). Of the 659 respondents, 187 (28.4%) were female, with the proportion of women differing between specialties (P = 0.02), ranging from 2/19 in cardiothoracic surgery to 9/16 in paediatric surgery (Box 1). The median age of respondents was 32 years (range, 24–50 years).

Most of the 659 respondents (627, 95.1%) were engaged in full-time clinical training, with 30 (4.6%) not in active clinical training, and only two (0.3%) in a part-time clinical training position. Both respondents who were working part-time reported working 40 hours per week, compared with a median of 60 hours per week for those in full-time clinical work. The small number of part-time trainees precluded further comparisons with full-time trainees.

An interest in flexible training was reported by 208 respondents (31.6%), being more common among women than men (54.3% [94/173] v 25.9% [114/441]; P < 0.001) (Box 2, A). There was no statistically significant difference in interest in flexible training by state or country (P = 0.82) or by hospital setting (rural, regional, tertiary) (P = 0.07) (data not shown). There was also no difference in interest in flexible training by age (P = 0.21), but junior trainees were more likely to express an interest than senior trainees (45.8% [60/131] and 38.4% [56/146] for SET years 1 and 2, respectively, v 24.8% [26/105] and 26.4% (23/87) for SET years 4 and 5–6, respectively; P = 0.002). Trainees interested in part-time training were more likely to express concerns regarding fatigue impairing their work performance and limiting their social or family life, inadequate work–life balance, and insufficient time for things outside surgical training, including study or research (Box 3 and Appendix).

General and orthopaedic surgery trainees were most likely to report an interest in flexible training (41.6% [116/279] and 32.5% [37/114], respectively), while cardiothoracic and vascular surgery trainees were least likely (6.7% [1/15] and 8.0% [2/25], respectively). Female general surgery trainees were more likely to be interested (65.2% [58/89]) than female trainees in other specialties (P = 0.04).

There was no significant difference in work–life balance satisfaction between male and female surgical trainees with respect to working ≥ 60 or < 60 hours per week (P = 0.48). About two-thirds of trainees reported currently working “too many” or “far too many” hours in terms of their preferred work–life balance (men, 62.0% [259/418] and women, 65.1% [110/169]). Trainees’ opinions on whether they had satisfactory time in their lives for things outside of surgical training are shown in Box 2, B.

Discussion

This study demonstrates a striking mismatch between interest in flexible training among Australasian surgical trainees and the number of trainees currently in a part-time post. Although 32% of trainees were interested in flexible training, less than 1% were engaged in part-time clinical training.

These results show a previously undocumented high level of interest in flexible training among both male and female trainees. The rate of interest among men was higher than the 13% rate reported among male general surgical residents and medical students in the United States.4 The leading factor known to motivate interest in flexible training is time for parenting,4,8 and the mean age of trainees in our study (32 years) coincides with the age when Australians would typically choose to become parents.9 Impact on family life has been found to be among the biggest regrets of US surgeons regarding their time in residency,4 and the American Surgical Association has previously called for increased flexibility in training to facilitate parenting.5 Our results show that similar efforts are required in Australasia. Limited opportunities for flexible training may discourage graduates from considering a surgical career.10–12

Our study also found that work-related factors are associated with interest in flexible training. On average, Australasian surgical trainees work more than 60 hours per week, and around 75% also perform on-call duties for a further 28 hours per week.7 A previous study of Younger Fellows of the RACS showed that those working more than 60 hours per week were at higher risk of “burnout”,13 which could perhaps be mitigated by increased work flexibility. Factors other than family and fatigue, such as health and academic interests, are also likely to contribute to interest in flexible training.4,8,14

Barriers to flexible surgical training that may explain the low uptake in our study include clinical, supervisory, trainee and employment factors.12,14,15 From a clinical and supervisory perspective, the potential impact of part-time training on continuity of care, and the associated need for additional handovers, is a concern.16 As part-time training occurs at a lower intensity and over a longer period, it may also be an impediment to gaining technical skills.15 Few educational data are currently available to assess this, but limited Australasian experience suggests quality outcomes can be achieved within the right model.14 Factors deterring trainees from flexible training include prolongation of training, a trade-off in salary and benefits, complexities in negotiating a part-time hospital contract, a perception of receiving “second-class training”, and discouragement from supervisors and other trainees.4,17 In addition, the limited availability of part-time hospital appointments is a key barrier.14 It may be difficult in some rotations to provide trainees with the necessary range of clinical experience (spanning acute, elective, operative and non-operative experience) in a flexible capacity.

Despite these challenges, opportunities exist to enhance the supply of flexible surgical training posts. Two possible models are job-sharing and stand-alone posts, both of which have successful precedents in Australia.12,14 Job-sharing can be facilitated by allowing trainees to “match” into suitable posts, but this typically must be planned months in advance and may be difficult in smaller specialties or regions. A possible path to advancing flexible training through a stand-alone model is through private hospital rotations, which are a focus of increasing interest in Australasia.18 Private sector training imposes opportunity costs on surgeon and hospital income,19 which could be partly offset by these positions being part-time, if quality operating exposure could be assured. Job-sharing in acute surgical units offers an opportunity to mitigate impacts on continuity of care, as scheduled handovers occur continuously during the 24-hour acute care model.20,21

Female students now outnumber male students in Australasian medical schools,22 and our study suggests the proportion of female trainees in surgery is also growing. Although only around 8% of qualified Australasian surgeons are women,23 we found that 28% of RACS trainees are women, indicating that a workforce transition is occurring. As we also found that more women than men are interested in flexible training, these demographic trends are likely to increase pressure for part-time training opportunities.

A limitation of our study is the sourcing of data from self-survey responses; however, the response rate was satisfactory.24 Further, a reported interest in flexible training may not translate into uptake of flexible training, even if the opportunities are available.

In conclusion, we believe efforts should be made to facilitate part-time surgical training in our region.

1 Sex of respondents by surgical specialty

2 Comparisons of male and female trainee responses to questions about interest in flexible training (A) and time outside training for other things (B)

* P < 0.001 for male v female. † P = 0.06 for male v female.

3 Factors associated with an increased interest in flexible training

Factor

Fatigue is impairing concentration or performance at work

0.009

Fatigue is limiting participation in social or family life

< 0.001

Current working hours are in excess of preferred work–life balance

< 0.001

Perceived insufficient time in life for things outside of surgical training

< 0.001

Perceived insufficient time for surgical study and research needs

0.003

* Each question was assessed on a five-point Likert scale. P values reflect χ2 analyses of Likert response and interest in flexible training. The full datasets for these analyses are provided as an Appendix (online at mja.com.au).

Flexible surgical training in Australasia

Establishing part-time surgical training posts may be difficult, but evidence suggests it is possible and increasingly necessary

The study by McDonald and colleagues confirms previous reports in Australia and elsewhere that there is a significant difference between the number of trainees who are undertaking some of their surgical training part-time and those who would be interested in doing so.1

It cannot be denied that doctors entering a career in surgery are now seeking a more balanced lifestyle. Generational change and associated lifestyle expectations, the feminisation of the workforce and changing working environments have contributed to the trend.2

While the Royal Australasian College of Surgeons (RACS) has had a policy supporting flexible surgical training for some years,3 it recognises that, by itself, this is not enough. The RACS has recently established the Flexible Training Working Party to look at how we can make the option of part-time training more of a reality for our trainees. Members of the working party include jurisdictional (ie, hospital and health department) representatives, and representatives from Colleges with a higher uptake of part-time training than the RACS. Jurisdictional representation on this working party is extremely important, as the College itself does not employ trainees; while it can accredit trainee posts, it does not create them.

The Royal Adelaide Hospital has successfully implemented an effective model for part-time surgical training.4 Interestingly, the position came about after lobbying to the state government produced the funding for a stand-alone 0.5 full-time equivalent position. An early concern for the hospital was the lack of guarantee that the post would be filled from year to year. However, the post has proven popular with trainees, with some even relocating from interstate to take up the position. It is important to note that this post is an accredited position with appropriate learning experiences for the trainee, and not a position designed to satisfy a trainee’s wish for a part-time commitment.

Several commentators have raised concerns that part-time training in surgery will affect the educational experience and that a lack of continuity may be an impediment to gaining proficiency in both technical and non-technical skills.5 Contrary to this is logbook evidence from the Royal Adelaide Hospital post, which showed equivalence between 12 months of flexible training and a full-time 6-month position. Furthermore, all trainees who undertook this part-time position subsequently obtained their Fellowship of the RACS.4

There is no doubt that some doctors are put off pursuing surgical training because it is not seen as compatible with raising a family or having an appropriate work–life balance. This contributes to the imbalance between the sexes in surgery, with only 30% of applicants for surgical training in 2012 being women. Although this has improved from the 9% of current active Fellows who are female,6 more than 50% of new graduating doctors are women, and more needs to be done to ensure surgery is not limiting its pool of available candidates.

The educational concerns relating to part-time training will continue to be debated, but McDonald et al’s study demonstrates a desire from trainees for flexible training options. Although the current surgical clinical training environment is not conducive to establishing posts that are less than full-time, the evidence suggests that it is possible. There is a real risk that the limited availability of flexible training options may deter some doctors from entering the field of surgery. However, until there are a proportion of flexible options for training available, these issues and concerns cannot be fully substantiated or explored. It is hoped that the outcomes of the RACS Flexible Training Working Party will lead to the establishment of more flexible training posts, enabling the many questions and issues raised to be resolved.

Honouring choices — life postmortem

A superb legacy is offered by a woman’s life cut short — her healthy organs

It’s no secret — I’m not surgically inclined. I generally find people’s insides unpleasant to see or handle.

More disquieting, surgical theatres depersonalise. When a person’s essence is reduced to a view of naked innards, neatly framed by sterile blue drapes, is it hostile to replace a cordial introductory handshake with a firm grip on their viscera? Although operations are consensual and intended to improve life, a thought lingers — who is the person on the operating table?

Even so, to a young intern, being invited to assist in theatre on my surgical rotation was a treat. Surgeons declare clinical convictions by steel blade, inflicting wounds to repair health. Such courage requires formidable confidence and arduous training. The surgeon’s reward is to command a theatre which, highly structured and intentionally austere, affords a protecting veil to facilitate their work.

Vocational chimeras, in each surgeon I perceive an architect, interior designer, builder, plumber and electrician of the human body. Their skill on display is impressive; time warps while dextrous hands renovate anatomy.

One day in the operating theatre, I met an exceptional patient — a healthy young woman, save for one quality. She was brain dead.

Long before we met, her healthy brain had formed a generous exit strategy for its fellow vital organs if the need arose — organ donation.

Twenty hours before we met, her brain had suffered the effects of a catastrophic subarachnoid haemorrhage. A transplant liaison team had been mobilised to support her anguished relatives, who then formed their verdict. Five hours before we met, the woman’s decision to donate her liver, kidneys, heart and lungs had been honoured. Thus an elaborate system was activated.

A liver transplant surgeon from another tertiary hospital arrived to procure the patient’s abdominal organs. Contrary to my fanciful surmise, he caught a taxi and not a helicopter. Unassuming entrance complete, the surgeon enlisted the day’s on-call surgical assistant — my senior resident.

Until then, our morning had been unremarkable. Postoperative patients were stable in the wards, the day’s tasks were already accomplished and the cricket attracted a growing audience around the television in the residents’ quarters.

Fascinated by the rare prospect of organ retrieval, I went to theatre and asked to observe. Enthusiastic and sporting full-length white overalls, the surgeon beamed. “You’ll never see anything like this, please scrub in and assist us.”

Few experiences in life wholly draw you into a situation, distort sensory coordination and tantalise your mind. As I scrubbed up, adrenaline coursed through me, and continued to do so long after the final suture.

Surgery is pre-eminent among medical fields regarding efficiency and outcomes — surgeons definitively thwart disease and injury with a scalpel. In this case, one life’s end would save five other lives.

When I assist in operations on the abdomen, I am usually underwhelmed by its organs. The liver, despite its essential functions, is aesthetically uninteresting and doesn’t even pulsate. Nor do kidneys. Bowels have the visual advantage of spontaneous activity, albeit reminiscent of the seething of primordial annelids. Overall, the abdominal cavity and retroperitoneal space display a menu of visually unexciting offal.

This patient’s abdominal contents briefly inspired a new level of interest as the surgeon established visual and tactile confirmation that they were free of overt disease. Satisfied, he prepared the liver and kidneys, and positioned ligatures behind major vessels.

In the spirit of team enterprise, he gained access to the thorax for the cardiothoracic surgeons. Witnessing my first median sternotomy, I saw the buzzing saw easily split the sternum then wax smeared on raw bone edges to halt bleeding. Thorax, prized open, revealed its jewel.

Her heart on debut to the external world, its beat revealed, fleetingly stopped my own.

Immediately the other viscera were demoted to their previous status. The shifting gleam of theatre lights reflected on her pericardium, as myocardium squeezed then eased, unhurried, beat after diligent beat. It compelled my fingertips to feel it fill, clench, hover and then quiver to reposition. Reluctantly, having no business in touching her heart, I resisted but my fingers yearned. Behind my right shoulder, abdominal preparations continued but faded from focus.

Oblivious to its exposure, resolute, her heart forced blood through passive bodily circuits with each contraction.

Existentially, the heart must coexist — other organs are essential to maintain homoeostasis, yet they are subordinate. Lungs require mechanical ventilation when the brainstem dies or when muscle and nerve function are disrupted. All organs require adequate perfusion. And all these things depend on a functioning heart, which beats without instruction.

The liver transplant surgeon stepped back when the cardiothoracic team arrived so I could get a better view. “I’ve seen a hundred”, he explained, “you should see this”.

Our patient’s tawny lungs, bearing the speckled carbon emblem of city living, were inflated and deflated by the anaesthetists, on request. Inspected and palpated by surgeons, they easily met requirements.

Her heart was scrutinised. Transplant liaison held a phone to the ear of the cardiothoracic surgeon, who confirmed to an interstate counterpart that “it’s a good little heart; definitely suitable”.

Everyone was poised, especially the patient. Cardioplegia was coordinated by the anaesthetic and cardiothoracic teams. Blood was replaced by chilled transplant medium and, inevitably, her heart began to falter. So did mine. Finally, when the great vessel cannulas bled clear, her heart arrested.

Respectful silence descended on the theatre, as redundant monitors were switched off and conversation diminished to essential communication.

Precious organs were transferred, carefully wrapped, to their crushed-ice baths. Clear plastic bags formed an interim sheath for transport, in the darkness of an esky, to distant recipients.

Not technically required that day, I was privileged to attend this woman’s intimate terminal event. Subspecialty surgical, medical and nursing staff converged with a grieving family to honour a dying woman’s wish.

Rescued from death, her organs survived to sustain the lives of other people.

In elegant solitude, her beating heart was a steady reminder that life is tenacious, right to the end. And evidence that sometimes, with breathtaking resolve, life defies mortality.

Note: Clinical details have been altered to protect patient and family privacy. Publication
has been approved by The Alfred Hospital Chief Legal Counsel and the Medical Director of
Organ and Tissue Donation, DonateLife Victoria.