Information Communicated with Patients in Decision Making about their Abdominal Aortic Aneurysm

Article Outline

• Abstract
• Materials and Methods
  • Setting
  • Checklist
  • Analyses
• Results
• Discussion
• Source of Funding
• Conflict of Interest
• Acknowledgements
• References
• Copyright

Abstract 

Objectives

To explore what kind of information surgeons communicate with patients diagnosed with an abdominal aortic aneurysm, and if the information provided regarding the disorder and treatment options available complies with legal requirements.

Methods

Dutch vascular surgeons sound-recorded consultations with their patients. Recordings were scored using a checklist based on ethical considerations and five statutory categories of information on: (1) the disorder, (2) procedure and aim of surgery, (3) consequences and risks of surgery, (4) watchful observation and (5) individual prognosis regarding state of health. Each category was represented by several information items, which were scored dichotomously (‘not mentioned’ or ‘mentioned’). A category was considered sufficiently addressed if at least one of its items was mentioned.

Results

Thirty-five consultations were recorded (13 patients with aneurysmal diameter <5.5 cm and 22 with diameter ≥5.5 cm). In a minority of recordings, all five categories were addressed: 1/13 (8%) and 9/22 (41%), respectively. None of the information items was discussed consistently in every recording. Although most patients were informed about the proposed treatment option (11/13; 85% and 19/22; 86%), the alternative treatment option was mentioned only occasionally (4/13; 31% and 14/22; 64%).

Conclusions

Patients with an abdominal aneurysm are informed inconsistently about their disorder and treatment options. Information is often less than that legally required. This may hinder shared decision making.

Keywords: Abdominal aortic aneurysm, Communication, Informed consent, Legal liability, Physician–patient relations

Key issues that need to be considered in decision making on conservative or surgical treatment of abdominal aortic aneurysms (AAAs) are the risk of rupture in relation to the size of the aneurysm, and the increased surgical risk of patients in case of advanced age or serious cardiovascular co-morbidity.¹, ², ³ In this complex dilemma, patient preferences need to be considered. Thus, patients need to be thoroughly informed to be able to weigh the pros and cons of the different options.

Adequately informing patients regarding their state of health and the treatment options available is fuelled by an ethical imperative and required by European legislation.⁴ It helps patients to determine their preferred treatment and to give realistic informed consent. From a legal point of view, the information conveyed to the patient should include (1) an explanation of the disorder, (2) explanation of the therapeutic option(s), (3) the inherent consequences, risks and benefits and (4) how these relate to the individual state of health, supplemented with (5) a discussion of alternative treatments.⁴

Ethical questions recur about how much information the surgeon should disclose.⁵ A recent publication addresses what actually should constitute ‘informed consent’ regarding the treatment of abdominal aortic aneurysms.⁶ Vascular surgeons agreed that the risk of mortality due to abdominal aneurysm repair should be disclosed. They could not agree on the disclosure of other complications of surgery and on what complication rates should be mentioned. In retrospect, some patients who had undergone abdominal aneurysm repair or had declined surgery reported to be unaware of their treatment options, and were inadequately informed before they had to decide on the treatment.⁷ It is unknown what information is actually communicated to patients with an abdominal aneurysm in the consulting room and the extent to which the standards of informed consent are met.

The present study aims to explore what kind of information surgeons communicate with patients diagnosed with an abdominal aortic aneurysm, and if the information provided regarding the disorder and treatment options available complies with legal requirements.

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Materials and Methods 

Setting 

In this prospective study, all vascular surgeons of a Dutch university clinic and four regional hospitals were asked to audiotape the consultations with their patients with an abdominal aneurysm at the outpatient clinic. Between June and September 2007, the surgeons were equipped with a tape recorder and instructed regarding its use and the supplementary patient information required for each recording. Realisation that one was being recorded was not considered to influence the content of the consultation, because previous research has shown this possible effect fades within a few minutes as the surgeon quickly returns to his or her standard communication routine.⁸

All consecutive patients with an abdominal aneurysm visiting the surgical outpatient clinic to discuss or evaluate the course of their disorder and treatment strategy were eligible. Being (non-)suitable for surgical repair was considered to be unimportant, because all patients should be informed about their current state of health and the treatment options available. No exclusion criteria were applied, except for patient's refusal of the consultation being recorded. Each patient gave verbal consent prior to starting the recording. The local medical ethics review board waived the need for ethical approval of this study.

Checklist 

In order to determine what kind of information surgeons communicate, a multidisciplinary team of vascular surgeons, medical psychologists and clinical epidemiologists developed a checklist with items to be rated when the recording was replayed. This checklist was based on ethical considerations and European (as well as Dutch) law.⁴, ⁹ Five categories are described under this law: (1) characteristics of the disorder; (2) the procedure and aim of therapy; (3) consequences and risks of therapy; (4) alternative treatment options and (5) an individual prognosis regarding state of health. In the checklist, each of these broad categories was represented by a set of information items specific to the situation of abdominal aortic aneurysm.

Since decision making concerning preventive abdominal aneurysm surgery versus watchful observation is about choosing between two medically reasonable options, both of which might induce significant harm, patient preferences are to be included in this decision.¹⁰ Therefore, a sixth category including two items was added to the checklist. One item referred to whether the surgeon made a statement regarding the possibility for the patient to participate in decision making; another item addressed whether patient preferences were explored (e.g., following a treatment proposal).¹¹

Analyses 

Initially, a preliminary analysis was performed to agree upon how certain items should be interpreted and coded. Subsequently, in order to assess inter-observer agreement, three raters (AK, AG and DU) independently replayed and coded the same four audiotapes. Kappa-values were calculated as a chance-corrected measure of agreement.¹² As substantial agreement between the raters was found (κ = 0.68; 95% confidence interval (CI): 0.58–0.79), a single rater (AK) subsequently coded all recordings.

All items were scored either as ‘not mentioned’ or ‘mentioned’. Scoring was performed liberally, that is, if an item was mentioned only briefly (e.g., ‘the bigger the aneurysm, the greater the risk that something happens’) rather than explained properly (‘the risk of aneurysm rupture increases when its diameter expands’), the item was registered as ‘mentioned’. In addition, if at least one item of a category was scored as ‘mentioned’, this category was labelled as ‘addressed’. For each of the five coding categories, we calculated the frequency of recordings in which this category was addressed. We also determined the number of statutory categories addressed for each recording. In theory, each category should have been ‘addressed’ (i.e., at least one item of the category mentioned) in each recording, irrespective of the (non-)suitability for surgical repair.

The analyses were performed in two subgroups, determined by the patients' aneurysmal diameter: patients with an abdominal aneurysm of diameter <5.5 cm and those with an abdominal aneurysmal diameter of ≥5.5 cm. This was done because risk of rupture increases with a larger diameter and, in general, the diameter threshold for preventive surgery is 5.5 cm. Therefore, the information given to patients with a larger aneurysm is more likely to be focussed on a surgical rather than a conservative approach.

In addition, for each recording, the patients' sex, age, diameter of abdominal aneurysm, number of previous consultations, presence of co-morbidity and the length of the recording were registered. After checking for normal distribution, these details were displayed with their means and standard deviations (SDs; or medians and interquartile ranges when no normal distribution was present).

Data on information items communicated to patients were descriptively analysed and displayed as absolute numbers and percentages.

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Results 

In total, 35 consultations, conducted by 11 vascular surgeons, were recorded. Patients and surgeons did not feel the recordings influenced their conversation. The characteristics of the patients and consultations recorded are shown in Table 1. Thirteen patients had an aneurysmal diameter <5.5 cm, and 22 patients had an aneurysmal diameter of ≥5.5 cm. Patient characteristics were typical for the disorder and representative for patients with an abdominal aneurysm visiting outpatient clinics in the Netherlands, suggesting that there was no selective loss of patients.

Table 1. Demographic data of the consultations and of patients with an abdominal aneurysm.

The five legally required information categories to be discussed about the disorder and treatment options were all addressed in one recording of a patient with an abdominal aneurysm <5.5 cm (1/13: 8%) and nine out of 22 consultations with patients with an abdominal aneurysm of ≥5.5 cm (41%, Table 2).

Table 2. Number of statutory information categories addressed.

The individual information items that were communicated varied considerably, that is, none of the information items was consistently discussed in every recording (Table 3). For patients with an abdominal aneurysm <5.5 cm, the amount of information communicated ranged from one to 18 out of 47 items per recording. Six to 20 items were communicated with patients who had an abdominal aneurysmal diameter ≥5.5 cm.

Table 3. Information communicated with patients with an abdominal aneurysm. Items not mentioned are marked white; items mentioned are marked black.

With regard to the content of information, the category of information on the disorder was addressed in just about all recordings (12/13, 92% and 21/22, 95%; Table 4) and even multiple information items were usually mentioned (Table 3). An individual prognosis taking the patient's state of health into account was also given to most of the patients (10/13, 77% and 22/22, 100%; Table 4), while multiple items out of this category were mentioned to some of them (4/13, 31% and 15/22, 68%; Table 3). Patients were rarely involved in decision making, as the fact that they could participate in decision making was mentioned to only a minority of them (1/13, 8% and 9/22, 41%; Table 3). Moreover, patient preferences with respect to (future) surgical repair or watchful waiting were infrequently explored (4/13, 31% and 4/22, 18%; Table 3).

Table 4. Number of consultations in which at least one item from the statutory category was mentioned.

For the majority of 13 patients with an abdominal aneurysmal diameter <5.5 cm, information regarding the watchful observation option was given (11/13, 85%; Table 3). However, aspects of the procedure or aim of surgery were mentioned in only a third of the recordings (4/13, 31%; Table 4), and consequences or risks of surgery were communicated in only two consultations (2/13, 15%; Table 4).

Among the 22 patients with an abdominal aneurysmal diameter ≥5.5 cm, the aim, procedure as well as consequences and risks of surgery were usually discussed (19/22, 86% and 18/22, 82%, respectively; Table 4) and even explained more extensively to a considerable number of patients (16/22, 73% and 12/22, 55%, respectively; Table 3), but the watchful waiting option was mentioned less often (14/22, 64%; Table 4).

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Discussion 

The information patients with an abdominal aneurysm receive from their surgeons regarding their disorder and whether to undergo surgical repair or follow a watchful observation strategy varies considerably. Only a minority of patients received information on all five categories according to the ethical and legal requirements of informed consent.

Whilst information regarding the disorder and the individual prognosis as to the state of health were usually given, the alternative treatment option was often not mentioned at all, which directs patients towards the treatment option that is preferred by the surgeon. This phenomenon has also occurred in previous studies of patients being informed about cardiac surgery and patients with advanced cancer being offered palliative chemotherapy.¹³, ¹⁴ In these studies, physicians provided information on cardiac surgery or chemotherapy, but it was not customary to discuss treatment options outside their field of expertise. In our study, patient participation in decision making regarding abdominal aneurysm treatment or patient preference regarding treatment was discussed in only a minority of consultations. This finding confirms the results of a previous qualitative study, in which patients with an abdominal aneurysm felt there was no choice regarding whether or not to have surgery.⁷

Our results probably embellish the actual situation, because information communicated in the recordings was scored favourably, in that only one item of a category needed to be mentioned in order to label that category as ‘addressed’. It is unlikely, though, that a patient with an abdominal aneurysm feels fully informed, for example, about consequences and risks of surgery, when he is merely told that he might die due to surgery. In other words, it will be necessary to explain certain categories more extensively, depending on the patient's condition and his or her information preference.

Several models have been described in response to this debate of what should be regarded as essential and adequate information. Information based on what other physicians would disclose in similar circumstances comprises the ‘professional model’; information determined by what a reasonable patient would want to know is the ‘reasonable model’ and information based solely on specific interests and values of the patient concerns the ‘subjective model’ of informed consent.¹⁵

Unfortunately, no specific model or guideline exists on what information is essential to be communicated to patients with an abdominal aneurysm. Recently, the professional, that is, the surgeon's, opinion was studied regarding which surgical complications should be disclosed and which complication risks should be mentioned.⁶ The only risk the vast majority of surgeons agreed upon to be included was mortality. Moreover, abdominal aneurysm patients themselves differed as to the information they desired: some wanted to know extensive details of each option, while others preferred less information.⁷ Therefore, acting in accordance with the professional model is difficult due to a lack of consensus, acting to the reasonable model would probably not satisfy the needs of all patients with an abdominal aneurysm, while acting to the subjective model is unfeasible as it is impractical to retrieve the patient's values and interests in detail. A combination of these approaches appears more appropriate.

Several limitations of this study have to be discussed. First, some patients with an abdominal aneurysm ≥5.5 cm were told that they were unfit for surgical repair due to major co-morbidity. They had been informed with the intention of watchful observation instead of focussing on surgical repair. However, this concerned just four patients and the results did not substantially differ in a sensitivity analysis. We, therefore, decided to describe all patients as a whole group.

Second, surgeons varied in that they focussed on different aspects of treatment information in different recordings. This is partly justifiable because a heterogeneous patient population (regarding aneurysm size, co-morbidity and number of previous consultations) was included in this study. Because of this heterogeneity within our limited sample size, we were not able to determine whether surgeons also differ in their communication if confronted with similar patients. Moreover, we might have missed particular information items that were discussed in previous consultations, as only one consultation was recorded per patient. We, therefore, decided at least one information item in each category ought to be mentioned to be regarded as sufficient.

In order to obtain a well-considered informed consent, we recommend communicating information on each of the five ethically and legally prescribed categories. Some categories will need to be discussed extensively, while others only need to be mentioned briefly, depending on the size of the patient's aneurysm, presence of co-morbidity and patient's prior knowledge of the disorder. Moreover, we emphasise that both the surgical and the watchful observation strategy should always be mentioned, because each option involves an uncertain but real risk of mortality. Since personal aspects are of paramount importance in this patient group, patients should be involved, or should be aware of the opportunity to be involved, in the decision making process. Although in some cases the treating surgeon is certain as to what treatment option is best, briefly describing all options will enhance the understanding and involvement of the patient in his/her treatment decision.¹⁶, ¹⁷

The communication process might be facilitated by means of a standardised information supply, which is able to tailor the information to the patient's medical condition and information needs. This standardised supply of information may counteract undesirable variability and incompleteness in patient education. Apart from being legally correct, this is likely to improve the uniformity and quality of care as provided by surgeons to patients who deserve to be properly informed regarding a potentially serious disorder.

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Source of Funding 

None.

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Conflict of Interest 

None declared.

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Acknowledgements 

We are grateful to all vascular surgeons at the Departments of Surgery of the Academic Medical Center (R. Balm MD PhD, M.M. Idu MD PhD, D.A. Legemate MD PhD, J.M. Schnater MD PhD), Amstelland Ziekenhuis (J.A. Lawson MD PhD), Flevoziekenhuis (R. de Vries MD, J.G. Kromhout MD PhD), Onze Lieve Vrouwe Gasthuis (A.C. Vahl MD PhD, M.J.T. Visser MD PhD, K. Türkçan MD), Tergooi Ziekenhuizen (M.J. Koelemay MD PhD) and their patients, who agreed upon having their consultations recorded.

We thank E.M.A. Smets, PhD, at the Department of Medical Psychology of the Academic Medical Center, for her intellectual input during the development of the checklist. We also thank L.C. Zandbelt, PhD, at the Department of Quality Assurance & Process Innovation of the Academic Medical Center for her intellectual support while drafting the manuscript.

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References 

1. Brown LC, Powell JT. Risk factors for aneurysm rupture in patients kept under ultrasound surveillance. UK small aneurysm trial participants. Ann Surg. 1999;230(3):289–296
   • View In Article
   • MEDLINE
   • CrossRef
2. Galland RB, Whiteley MS, Magee TR. The fate of patients undergoing surveillance of small abdominal aortic aneurysms. Eur J Vasc Endovasc Surg. 1998;16(2):104–109
   • View In Article
   • Abstract
   • Full-Text PDF (455 KB)
   • CrossRef
3. Glimaker H, Holmberg L, Elvin A, Nybacka O, Almgren B, Bjorck CG, et al. Natural history of patients with abdominal aortic aneurysm. Eur J Vasc Surg. 1991;5(2):125–130
   • View In Article
   • MEDLINE
   • CrossRef
4. Convention on human rights and biomedicine. vol. 07. Council of Europe; 2009;
   • View In Article
5. Palmboom GG, Willems DL, Janssen NB, de Haes JC. Doctor's views on disclosing or withholding information on low risks of complication. J Med Ethics. 2007;33(2):67–70
   • View In Article
   • MEDLINE
   • CrossRef
6. Berman L, Dardik A, Bradley EH, Gusberg RJ, Fraenkel L. Informed consent for abdominal aortic aneurysm repair: assessing variations in surgeon opinion through a national survey. J Vasc Surg. 2008;47(2):287–295
   • View In Article
   • Abstract
   • Full Text
   • Full-Text PDF (108 KB)
   • CrossRef
7. Berman L, Curry L, Gusberg R, Dardik A, Fraenkel L. Informed consent for abdominal aortic aneurysm repair: the patient's perspective. J Vasc Surg. 2008;48(2):296–302
   • View In Article
   • Abstract
   • Full Text
   • Full-Text PDF (90 KB)
   • CrossRef
8. Coleman T. Using video-recorded consultations for research in primary care: advantages and limitations. Fam Pract. 2000;17(5):422–427
   • View In Article
   • MEDLINE
   • CrossRef
9. http://www.hulpgids.nl/oud/wetten/wgbo-tekst.htm2009;Internet
   • View In Article
10. Whitney SN, McGuire AL, McCullough LB. A typology of shared decision making, informed consent, and simple consent. Ann Intern Med. 2004;140(1):54–59
    • View In Article
11. Braddock CH, Edwards KA, Hasenberg NM, Laidley TL, Levinson W. Informed decision making in outpatient practice: time to get back to basics. JAMA. 1999;282(24):2313–2320
    • View In Article
    • MEDLINE
    • CrossRef
12. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33(1):159–174
    • View In Article
    • MEDLINE
    • CrossRef
13. Koedoot CG, Oort FJ, de Haan RJ, Bakker PJ, de Graeff A, de Haes JC. The content and amount of information given by medical oncologists when telling patients with advanced cancer what their treatment options are palliative chemotherapy and watchful-waiting. Eur J Cancer. 2004;40(2):225–235
    • View In Article
    • Abstract
    • Full Text
    • Full-Text PDF (265 KB)
    • CrossRef
14. Vohra HA, Ledsham J, Vohra H, Patel RL. Issues concerning consent in patients undergoing cardiac surgery-the need for patient-directed improvements: a UK perspective. Cardiovasc Surg. 2003;11(1):64–69
    • View In Article
    • MEDLINE
    • CrossRef
15. Childers R, Lipsett PA, Pawlik TM. Informed consent and the surgeon. J Am Coll Surg. 2009;208(4):627–634
    • View In Article
    • Full Text
    • Full-Text PDF (502 KB)
    • CrossRef
16. van Tol-Geerdink JJ, Leer JW, van Lin EN, Schimmel EC, Huizenga H, van Daal WA, et al. Offering a treatment choice in the irradiation of prostate cancer leads to better informed and more active patients, without harm to well-being. Int J Radiat Oncol Biol Phys. 2008;70(2):442–448
    • View In Article
    • Abstract
    • Full Text
    • Full-Text PDF (178 KB)
    • CrossRef
17. Reise JA, Sheldon H, Earnshaw J, Naylor AR, Dick F, Powell JT, et al. Patient preference for surgical method of abdominal aortic aneurysm repair: postal survey. Eur J Vasc Endovasc Surg. 2010;39(1):55–61
    • View In Article
    • Abstract
    • Full Text
    • Full-Text PDF (209 KB)
    • CrossRef