Aortic aneurysm trials in octogenarians: Are we really measuring the outcomes that matter?

Abstract

Purpose

This study is a systematic review to determine the types of outcomes reported in abdominal aortic aneurysm (AAA) studies of patients aged 80 and over. Specifically, it determines the types of patient-centered outcomes reported.

Method

MEDLINE and EMBASE were searched from 2000 to 2014 for studies on AAA surgery with outcome data on patients aged 80 and over. Outcomes were categorized according to Donabedian’s framework for health quality indicators, with further classification as procedural, complication, resource or patient-centered outcome indicators.

Findings

Forty studies were reviewed. Patient-centered outcomes were infrequently reported (13%, n=5), with limited outcomes specifically relevant to older patients. No studies reported physical function, activities of daily living or cognition using validated assessment methods. Short-term mortality (95%, n=38) and complications (85%, n=34) were reported most frequently.

Conclusion

Reporting of aortic surgery outcomes in patients aged 80 and over requires a focus upon outcomes of primary importance to people of this age.

Keywords

Patient outcome assessment aortic aneurysm abdominal aged 80 and over quality indicators health care patient-centered care review systematic

Introduction

Surgical interventions in older patients are common; for instance, over one-third of older patients in the United States undergo surgery in their last year of life.¹ The impact a procedure has on quality of life (QOL)—including symptoms, mental and physical well-being, and functional capacity—is often more of a priority to older patients than survival or complication risk.² Moreover, many patients state they would choose not to have surgery if they knew the outcome would be severe functional or cognitive decline.³

Not only do older patients express different treatment goals than younger patients but also they are more likely to suffer adverse events and complications following surgery.⁴ Older vascular patients have a higher operative risk profile, with increased risk of peri-operative complications and supportive care requirements compared to younger cohorts. When complications arise, the consequences are often worse for older patients.^5,6 Older patients also have greater risk of specific complications such as delirium, falls, pressure sores, pneumonia, and decreased mobility.⁵

There is an acknowledgement that it is important to report quality of care outcomes that are relevant to older patients undergoing surgical interventions but is unclear how well this has been reported in aortic aneurysm studies to date.⁷ Surgeons and their older patients may have different perspectives on which are the most important outcomes, and traditional measures of morbidity and mortality are recognized as insufficient for informed clinical decision-making and patient-centered care.⁸ Surrogate indicators for quality of care, such as clamp time, limb ischemia, endoleaks, or graft migrations are important makers of technical success but have little relevance to patient values and concerns.

The advent of endovascular aneurysm surgery (EVAR) has resulted in many studies examining the safety and efficacy of aneurysm surgery in patients aged 80 and over. Accordingly, abdominal aortic aneurysm (AAA) surgery is a suitable index procedure to assess if patient-centered outcomes are measured and reported in clinical studies specifically including older surgical patients. We wanted to determine if studies that evaluated the outcomes of aortic aneurysm surgery in patients aged 80 and over adequately addressed patient-centered outcomes that relevant to this age group. The aim of this study is to determine what outcomes were reported in AAA surgery studies that focused on patients aged 80 and over. To do this we conducted a systematic review to find and appraise the relevant literature.

Method

A systematic search for of all studies reporting the results of AAA intervention in patients over the age of 80 was performed. We searched the databases MEDLINE and EMBASE (January 2000 to June 2014). The MeSH terms abdominal aortic aneurysm and aged 80 and over were supplemented by key word searches using octogenarian, nonagenarian, and elderly. Searches were not limited by study design or language. Four systematic reviews were found relating to this topic, and their reference lists were checked to ensure concordance with the search results for individual studies.^9–12 Studies were included for review if they reported any outcome indicator of aortic aneurysm surgery, either open or endovascular, in patients who were 80 years or older. If a subgroup analysis of patients aged 80 and over was performed in a study not restricted to older people, these studies were also considered for inclusion. Articles that reported outcomes only for ruptured aneurysms were excluded; however, if elective and ruptured aneurysms were combined, these studies were included. Clinical trials along with case-control, cohort and cases-series (with more than 10 participants) were included. Case reports and conference proceedings were excluded. Study quality was not a factor for inclusion, or assessed in this systematic review, as the focus was on the range of outcome indicators reported. By excluding studies of lesser quality, some important outcome measurements might be missed, particularly those related to functional or well-being outcomes.

The Donabedian paradigm of structure, process and outcome was used as a framework to classify health outcomes reported.¹³ Structural indicators refer to characteristics of the system in which the patient receives their care, for example, the volume and specialization of the surgical units. Process indicators refer to the application of programs of care delivery, that when implemented, are known to result in improvements of health care quality, for example, adherence to antibiotic prophylaxis represents decreased surgical site infections. Finally, outcome indicators refer to the end results of surgical intervention, including measures of morbidity and mortality; these are the most commonly used indicators. Patient-centered outcomes are generally defined as those outcomes that assist patients in their decision-making and take priority in importance, for example symptom control, functional alterations, or QOL indicators.^8,14 Patient-centered outcomes can be represented in each Donabedian indicator.

The types of surgical outcomes were assessed for each study. The outcomes reported were classified using the Donabedian paradigm into three groups: structure, process, and outcome indicators.¹³ Outcome indicators were further classified into four subgroups: procedural, complications, resource usage, and patient-centered outcome indicators. Mortality was viewed as a separate outcome indicator. Procedural indicators were defined as measures that related to the technical aspects of aortic surgery, such as clamp time, blood loss, or duration. Resource usage indicators were defined as outcomes directly related to the level of care required and access to hospital facilities, such as length of stay, use of intensive care, or re-interventions. Complication indicators were of two types: (i) direct reporting of individual complications, or (ii) reporting of complications using a validated tool such as the Clavien-Dindo classification of surgical complications.¹⁵ Patient-centered outcome indicators were outcomes such as QOL, physical function, cognition, and discharge destination/institutionalization. To be considered to have reported QOL, studies needed to have used a validated QOL score. Similarly, functional assessment required formal measurements of functional status utilizing validated functional assessment tools, such as Katz’s ADL scale.¹⁶ Self-reported functional assessment in QOL scores was not considered as an outcome indicator of physical function. Table 1 and Figure 1 provide further detail into the subgroup analyses of Donabedian outcome indicators.

Table 1.

Study characteristics and reported quality of care indicators.

Author, Year	Country	Gender (Male: Female)	Age (mean)	Study type	Study size	Outcome indicators
						Structure	Process	Outcomes
								Procedural	Resource	Complications	Patient- Centered
Cohen, Singer et al. 2000	Israel	NA*	NA	Case control	16	✗	✗	✓	✓	✓	✗
Sicard, Rubin et al. 2001	USA	65:25	82.9	Cohort	90	✗	✗	✓	✓	✓	✗
Lobato, Rodriguez-Lopez et al. 2001	USA	43:7	82	Case series	50	✗	✗	✓	✗	✓	✗
Mailapur, Yousuf et al. 2001	USA	38:24	82.9	Case series	62	✗	✓	✗	✓	✓	✗
Valdes, Bergoeing et al. 2003	Chile	NA	NA	Cohort	58	✗	✗	✗	✗	✗	✗
Patel, Langan et al. 2003	USA	39:12	83	Cohort	51	✗	✗	✓	✓	✓	✗
Biebl, Lau et al. 2004	USA	43:6	83.6	Cohort	49	✗	✗	✓	✓	✓	✗
Brinkman, Terramani et al. 2004	USA	29:2	83	Case series	31	✗	✓	✓	✓	✓	✗
Minor, Ellozy et al. 2004	USA	119:31	84.6	Cohort	150	✗	✓	✓	✗	✓	✗
Merlo, Bitossi et al. 2004	Italy	NA	82.8	Cohort	43	✗	✗	✗	✗	✗	✗
Lange, Leurs et al. 2005	Europe	629:68	83.4	Cohort	697	✗	✗	✓	✓	✓	✗
Haug, Romundstad et al. 2005	Norway	82:23	82	Cohort	105	✓	✗	✗	✓	✓	✗
Dainese, Barili et al. 2006	USA	25:5	82.2	Cohort	30	✗	✓	✗	✓	✓	✗
Baril, Palchik et al. 2006	USA	16:0	92.4	Case series	16	✗	✗	✓	✓	✓	✗
de Donato, Setacci et al. 2007	Italy	NA	83.6	Cohort	44	✗	✗	✓	✗	✓	✗
Ishibashi, Ohta et al. 2008	Japan	NA	83	Cohort	77	✗	✗	✓	✗	✗	✓
Paolini, Chahwan et al. 2008	USA	NA	83.5	Case control	150	✗	✗	✓	✓	✓	✓
Ballotta, Da Giau et al. 2008	Italy	79:32	83.9	Cohort	111	✓	✗	✓	✓	✓	✗
Nano, Bianchi et al. 2008	Italy	NA	84	Case series	30	✗	✓	✗	✓	✓	✗
Rousa, Pane et al. 2009	Italy	32:3	83.3	Cohort	35	✗	✗	✗	✓	✓	✗
Mani, Bjorck et al. 2009	Sweden	734:219	82.1	Cohort	953	✗	✗	✗	✗	✗	✗
Thomson, Goh et al. 2009	New Zealand	117:51	82.4	Cohort	168	✓	✗	✗	✗	✓	✗
Botsios, Schmidt et al. 2009	Germany	24:1	83	Case series	25	✗	✗	✓	✓	✓	✗
Kurz, Meier et al. 2010	Switzerland	31:7	83	Cohort	38	✗	✗	✗	✓	✗	✓
Fonseca, Rockman et al. 2010	USA	86:31	85	Cohort	117	✗	✗	✗	✓	✓	✗
Jim, Sanchez et al. 2010	USA	12:6	91.2	Case series	18	✗	✗	✓	✓	✓	✗
Holt, Poloniecki et al. 2010	UK	NA	NA	Cohort	NA	✗	✗	✗	✓	✗	✓
Prenner, Turnbull et al. 2010	USA	253:69	84	Cohort	322	✗	✓	✓	✓	✓	✗
Capoccia et al. 2010	Italy	62:20	82.8	Cohort	82	✗	✗	✓	✓	✓	✗
Goldstein, Halpern et al. 2010	USA	15:9	91.5	Case series	24	✗	✗	✗	✓	✓	✗
Geisbusch, Katzen et al. 2011	Germany	278:41	87.7	Cohort	279	✗	✗	✓	✓	✓	✗
Scheer, Pol et al. 2011	Germany	NA	>80	Cohort	46	✗	✗	✗	✓	✓	✗
Martinez-Mira, Alonso-Argueso et al. 2011	Spain	50:3	83	Cohort	53	✗	✗	✗	✓	✓	✗
Woo, Ullery et al. 2011	USA	27:38	82	Cohort	65	✗	✗	✓	✓	✓	✗
Pol, Zeebregts et al. 2012	Multicentre	237:37	83.3	Cohort	274	✗	✗	✓	✓	✓	✓
Raval et al. 2012	USA	1568:466	>80	Cohort	2034	✗	✗	✓	✓	✓	✗
Zhang, Guo et al. 2013	China	11:1	92.5	Case series	12	✗	✓	✓	✓	✓	✗
Visser, Pol et al. 2014	Netherlands	86:11	82	Case control	97	✗	✗	✓	✓	✓	✗
De Blic, Alsac et al. 2014	France	54:5	87	Case control	59	✗	✗	✓	✓	✓	✗
Lee, Ullery et al. 2014	USA	14:1	90.3	Case series	15	✗	✗	✓	✓	✓	✗

Information not available within the published studies.

Results

The search strategy yielded a total of 2570 abstracts for review. From this, 125 were selected for full text analysis, from which 40 articles met the inclusion criteria. Figure 2 shows the literature search process in detail. An additional two articles were found from the reference list of the full text articles. Four articles were published in languages other than English but English translations were obtained.^17–20 The main reasons for exclusion were studies did not include a separate analysis of patients 80 years and over, only reported results of ruptured aneurysm repairs or were cases series of less than 10 patients. The four systematic reviews identified were excluded from the final analysis because their constituent studies were individually included.^9–12 Table 2 describes the included study characteristics in more detail.

Table 2.

Frequency of outcome indicators reported in 40 AAA studies on patients aged 80 and over.

Outcome indicators	Number of studies		%
Procedural outcomes	Technical success	15	37.5
	Procedure duration	13	32.5
	Blood loss	11	27.5
	Intraoperative complications	2	5
	Clamp time	2	5
	Transfusion requirements	3	7.5
	X-ray screening time	1	2.5
	Contrast use	2	5
	Device malfunction	1	2.5
	Clinical success	3	7.5
Resource utilization	Length of stay	24	60
	Intensive care unit stay	15	37.5
	Ventilation requirements	3	7.5
	Readmission to hospital	2	5
	Re-intervention rates	16	40
Complications	Descriptive report	29	72.5
	Limb occlusions	7	17.5
	Conversion (EVAR to open surgery)	12	30
	Endoleaks	17	42.5
	Graft migration	2	5
	AAA rupture/mortality	10	25
Patient-centered outcomes
	Discharge Destination/institutionalization	2	5
	Quality of Life	3	7.5
	Physical function	0	0
	ADL/IADL	0	0
	Cognition	0	0

Of the 40 studies selected for further analysis^10,17–57 none were randomized controlled trials. There were 26 cohort studies, 4 case-control studies, and 10 case series. In two instances, the same study resulted in two publications but were considered one study in our analyses.^29–31,58. Sixteen studies provided data on patients 80 years and over as a subgroup for analysis. The median study size was 56 participants (range 12–2034), with a total number of patients being 6576. In 16 studies (1637 patients), the intervention was open aortic surgery, while in 24 studies (3915 patients) the intervention was endovascular aortic repairs (EVAR). The mean age of study participants was 84 years (range 80–95 years).

Mortality

The majority of studies reported mortality outcome indicators. Almost all studies (n=38, 95%) reported 30-day or overall perioperative mortality rates. Follow-up length ranged from 30 days (or an undefined perioperative period) to 5 years. Longer term mortality or survival statistics (defined as greater than 30 days) were reported in 24 (60%) of studies. Aneurysm related mortality was reported in 10 (25%) studies.

Structural indicators

Only three studies reported outcomes considered structural indicators. Thompson et al reported a trend towards lower mortality after AAA surgery in New Zealand hospitals with less than 400 beds.²⁴ Haug et al.⁴⁵ analyzed the impact of increasing the volume and access to aneurysm surgery in patients 80 years and over. They reported an increasing number of procedures performed on octogenarians over the study period, but with no significant variation in mortality. Ballotta et al.⁵⁷ examined the effect that introducing an endovascular stenting program had on the results of open surgery for AAA. They found that although procedural complexity in the open aneurysm repairs increased, this did not significantly alter the occurrence of perioperative deaths or major complications.⁵⁷

Process indicators

Process indicators were reported in seven studies. These mainly focused upon preoperative assessment, with two reporting cardiac assessment and comorbidity ranking.^51,54 One study reported that all patients underwent cardiac monitoring³⁷ and attributed improved cardiac morbidity to this. The remaining reported on differences between general anesthesia and loco-regional anesthesia.^20,21,29,34

Outcome indicators

The majority of studies reported outcomes that could be classified as a Donabedian outcome indicator. Complication rates were the most frequently reported outcome (n=34, 85%). Most studies reported individual complication data in a descriptive format (n=29, 73%). Eight studies provided combined morbidity scores or counts of complications. Three studies grouped complications into the systems affected (for example cardiorespiratory, renal), whilst four studies divided complications into those that were local/vascular in nature compared to systematic complications. Raval et al.⁵⁹ used the predefined composite reporting structure associated with the large USA hospital survey, the National Surgical Quality Improvement Program (NSQIP). No studies reported complications based upon validated standardized complication reporting scales such as the Clavien-Dindo Scale¹⁵ or Postoperative Morbidity Score.⁶⁰ Specific to the 24 endovascular aortic surgery studies, the most frequently reported complications were endoleaks (n=17, 71%), conversion to open surgery (n=12, 50%), or graft migration (n=2, 0.08%).

Procedure-specific outcome indicators were reported in 25 studies (n=63%), especially for trials focused upon the technical feasibility of either open or endovascular interventions. Procedural outcomes included technical success, procedure duration, blood loss and transfusion requirements, clamp times, and use of X-ray screening time and contrast.

Resource utilization outcome indicators reported included length of stay (n=24 studies, 60%) and use of intensive care facilities (n=15 studies, 38%). Re-interventions and readmissions were also classified as resource-related outcomes. Re-intervention rates were reported in 18 studies.

Patient-centered outcomes were classified as indicators that pertained to clinical improvements (clinical success), QOL, functional indicators, or discharge destinations. Two studies reported discharge destination following intervention.^33,44 Three studies reported QOL results, using the Nottingham Health Survey,⁴¹ the EQ-5D,³¹ and the SF-36.⁴³ No studies reported specific functional outcomes, activities of daily living or care requirements. None of the studies reported on mobility or cognition.

Discussion

This review of published trials of AAA interventions in older patients highlights a striking deficiency in the measurement and reporting of patient-centered outcomes. The concept of patient-centered care is not new; it focuses upon provision of health care that is oriented towards enhancing patient autonomy and involvement in their illness management. It is responsive to the expressed values, preferences and needs of patients. The Patient-Centered Outcomes Research Institute (PCORI) defines patient-centered research as those studies that “identify and investigate outcomes that people representing the population of interest notice and care about (survival, function, symptoms, health-related QOL) and that inform a health related decision”.⁸ Measuring surgical outcomes in terms of patient-centeredness has gained increasing recognition; patient-centeredness results in enhanced health outcomes with the benefits of improved compliance and satisfaction, decreased anxiety, and improved QOL.⁶¹

In this systematic review, we looked specifically for patient-centered outcomes such as indicators of QOL, physical function, discharge destination, and cognition. From other studies comparing older surgical patients to younger patients, we hypothesize that functional decline, increased care requirements, decreased QOL, risk to cognition, and poor symptom control are more important concerns than survival time for patients aged 80 and over.^5,62,63 Our definition of patient-centered outcomes is based on these findings. Our study found that studies in aortic aneurysm surgery, despite being focused on patients aged 80 and over, rarely or never measured patient-centered values in their outcome indicators. A limitation of our study is that these “patient-centered outcomes” have been determined by the researchers—to truly identify patient’s concerns, further study into the expressed values and needs of elderly aortic aneurysm patients is required. Dubois et al.⁶⁴ identified that patients of all ages value physical function and recovery time over the risk of major complications or death from AAA surgery. The anticipated QOL changes, impact on carers and risk of nursing home placement were also significant factors in patient’s decision-making.

Aortic aneurysm interventions are associated with an overall initial decline in QOL, based on studies on adults of all ages.^65,66 In our review of data in patients aged 80 and over, only three studies utilized validated health-related QOL measurement tools in their outcome measurements.^30,41,43 All three of these studies identified an initial decline in QOL for older patients. In the Engage registry, which used the EQ-5D, both older and younger patients experienced a decline in QOL at discharge. At 30 days, this decline was persistent in older patients but had returned to baseline for the younger cohort.³¹ In this study, for patients aged 80 and over, the significant reduction in their QOL was attributed to decreased mobility, impaired return to usual activities and reduced self-care at 30 days after EVAR when compared to younger patients.³¹ This finding is similar to that of Kurz et al.,⁴¹ who noted older patients reported a decline QOL due to reduced physical ability after EVAR.⁴¹ These results are limited due to the poor response of older patients to the HRQOL survey (20 respondents from 38 participants). Ishibashi et al.⁴³ assessed HRQOL using the SF-36 questionnaire in a cohort of septuagenarians and octogenarians. This study reported an increase in pain post-operatively that persisted at three months but returned to baseline at 12 months. Of interest, mental health scores improved after surgery, and continued to increase at 12 months follow up.⁴³ Apart from these studies, there is limited evidence on the specific impact of aortic aneurysm surgery on QOL for patients aged 80 and over, and further studies using validated QOL measures are required to explore the impact of aortic surgery in older patients.

Validated long term functional assessments were not performed in any studies included in this review. The QOL survey EQ-5D used in the ENGAGE registry included questions on self-reported functional capacity.³¹ Older patients reported that they had impaired functional capacity at 30 days follow up and took longer to return to baseline function after surgery when compared to younger patients. Although not isolated to octogenarians, Williamson et al.⁶⁷ found higher institutional care requirements, prolonged recovery, and functional impairment in older patients after open aneurysm repair. In hindsight, 18% of study patients would have chosen not to undergo surgery if they had known the impact on their functional capacity.⁶⁷ Discharge destination can be a surrogate indicator of function; patients who are unable to return to their own homes after surgery demonstrate decreased levels of post-operative function. In a study using UK National Health Service administrative data, patients over the age of 80 had a significantly higher risk of not being discharged to their own home after aortic aneurysm surgery than younger patients. Whilst many of these patients were transferred to another hospital for rehabilitation or convalescence, 15% required nursing home placement. For many older patients, the risk of nursing home placement is a deterrent from surgery.⁶² There is insufficient evidence to quantify this risk for older patients who are undergoing aortic aneurysm surgery—a significant deficit for informed patient-centered decision-making.

This review highlights the need to assess and quantify the impact that complications have on the older patient population. Older patients have a higher risk of perioperative complications than younger patients.^6,68 In our review, complications were the most frequently reported outcome indicator. Despite this, consistent, reproducible methods for classifying complications were rarely used. No studies utilized a validated complication reporting structure such as the Clavien-Dindo classification¹⁵ or the Postoperative Morbidity Score (POMS).⁶⁰ Whilst complication rates are not considered as patient-centered outcomes in this review, it is acknowledged that complications are a concern for both surgeons and patients alike. Furthermore, all complications are not equal—older patients experience greater setbacks from certain complications. Geriatric-specific complications such as delirium, falls, pressure ulcers, and immobility have been shown to increase length of stay and increase the risk of nursing home placement.⁶³ In this review, only one study reported postoperative delirium rates and found that delirium correlated with prolonged length of hospital stay.³⁷ For studies focused upon aortic aneurysm surgery in patients 80 and over, the complications were most frequently related to technical and procedural aspects of the perioperative period and did not address “non-surgical” complications.

Vascular surgeons can learn from the geriatric medicine literature regarding optimal methods for assessing physical function and cognition. Indices of physical function such as the Katz Activities of Daily Living (ADL) Scale,¹⁶ the Instrumental Activities of Daily Living (IADL) scale⁶⁹ or frailty measures^70–72 have all be validated as predictive of function and health outcomes in older surgical patients.⁷³ Cognitive function can be measured with well-developed screening tests that are reliable and valid such as the Mini-Mental Scale⁷⁴ and RUDAS scores.⁷⁵ There is a high incidence of potentially preventable complications in older surgical patients that may decrease with geriatrician involvement in perioperative care.⁷⁶ With functional and QOL goals at the forefront for older patients’ expectations from surgery, new models of care for patients aged 80 and over undergoing aortic aneurysm surgery are required. The orthogeriatric model of shared surgeon/geriatrician care has significantly reduced mortality after hip surgery by actively addressing “geriatric specific” complications in the context of multi-morbidity.⁷⁷ Models similar to this need to be explored in the management of older patients undergoing aortic surgery. To determine the type of interventions that might help it is important to have good quality data on the frequency and type of “geriatric specific” complications that occur in this group of patients.

This review highlights a need to align research objectives with patient-centered outcomes for aortic aneurysm trials in patients aged 80 and over. This change is not onerous; the elements of a systematic approach to patient-centered outcome research can be brought across from other disciplines such as geriatric medicine and orthogeriatric surgery. Our review has discussed key indicators that are relevant to older patients- physical function, cognition, QOL, and discharge destination. Patient-reported outcomes such as these need to be incorporated into treatment discussions and clinical practice. A shift away from ad hoc reporting towards systematic, evidence-based trials that incorporate validated outcome measures is required. Utilization of standardized, qualitative outcome measures will assist in determining ongoing reporting standards and the timely and applicable dissemination of clinical trial results for older patients with aortic aneurysms.

Conclusion

This review highlights the need for accurate and informed information regarding the quality and safety of aortic surgery in older patients. If we are to engage in patient-centered care, the outcomes reported on in major trials needs to reflect the key concerns of the target population, as well as other domains. For high risk, very old patients, the role for surgery is often not clear-cut and patient preferences may be influenced by outcomes such as function and QOL over survival and technical considerations. Counselling regarding the treatment options, explaining risks and benefits and making recommendations depend upon accurate information about all potential results of care. Concepts of multidisciplinary care and shared decision-making are critical to the provision of quality perioperative care in older surgical patients. Not only do these require a culture shift for surgeons, but a change in the reporting and measurement of surgical practice is also needed. If further clinical trials are to be conducted on older patients, recognition and assessment of the unique outcomes, risks and concerns of these patients should also be performed to make sure that these trials translate into better care and outcomes.

Footnotes

Acknowledgements

Preliminary findings were presented at the Australian Surgical Research Society Meeting, Adelaide, SA, Australia, November 2014.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article:

The primary author is supported by grants from the University of Sydney Medical Foundation Chapman Bequest and the Royal Australian College of Surgeons Senior Lecturer Fellowship.

University of Sydney Medical Foundation, Room 204, Edward Ford Building A27, The University of Sydney, NSW, Australia, 2006. T: +61 2 9036 9181.

Royal Australian College of Surgeons Scholarships, 199 Ward St, North Adelaide SA, Australia 5069. T: +61 8 8219 0900.

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