Informed consent for abdominal aortic aneurysm repair: The patient's perspective

Article Outline

• Abstract
• Methods
  • Study design and sample
  • Data collection
  • Data analysis
• Results
  • Theme #1: Patients did not appreciate the scope of their options
  • Theme #2: Patients demonstrated that they were not adequately informed prior to making a decision
  • Theme #3: Patients differed in the scope and content of information they desired
  • Theme #4: Trust had an impact on the informed consent process
• Discussion
• Conclusion
• Author contribution
• Acknowledgment
• Appendix. Interview guide (online only)
• References
• Copyright

Objective

Whether or not to undergo surgery for abdominal aortic aneurysm (AAA), and whether to have open or endovascular repair (EVAR), is a complex decision that relies heavily on patient preferences, and yet little is known about the patient perspective on informed consent in this context. This study explores patients' views on their decision-making processes and the quality of surgeon-patient communication during informed consent for AAA repair.

Design of study

We conducted in-depth interviews with AAA patients (n = 20) who underwent open AAA repair, endovascular repair, or declined surgery. Data were independently transcribed and analyzed by a team of individuals with diverse backgrounds, using the constant comparative method of analysis and systematic coding procedures.

Setting

Patients who had seen surgeons from academic, private practice, and VA settings were interviewed.

Main outcome measure

Patients' opinions regarding the nature, scope, and content of informed consent for AAA repair.

Results

We identified four central themes characterizing patients' experiences with informed consent for AAA repair: 1) patients did not appreciate the scope of their options; 2) patients demonstrated that they were not adequately informed prior to making a decision; 3) patients differed in the scope and content of information they desired during informed consent; and 4) trust in the surgeon had an impact on the informed consent process.

Conclusion

Our research highlights the limitations of the informed consent encounter in the current clinical context, and points to several ways in which informed consent could be improved. Adapting the informed consent encounter to incorporate the patient's perspective is critical in order to ensure that the decision regarding AAA repair is consistent with the patient's informed preference.

Patients with abdominal aortic aneurysms (AAA) face a difficult decision: whether or not to undergo surgery for a condition that is usually asymptomatic, and for which the natural history is uncertain. The decision to have surgery, and if so, whether to have open repair or endovascular aneurysm repair (EVAR), relies heavily on patients' preferences.¹ In order to make decisions that are consistent with their individual preferences, patients must fully understand the distinct risks and benefits of each alternative as presented during informed consent.² When patients are fully engaged in the informed consent process, they are likely to be more satisfied with their decision and may experience better outcomes.³ This process is a venue through which surgeons and patients can develop a joint commitment to a plan of management.

Evidence indicates that patients are not always well-informed about potential outcomes of surgical intervention.⁴, ⁵, ⁶, ⁷, ⁸, ⁹ Stanley et al found that 25% of patients undergoing lower extremity bypass or carotid surgery had a poor understanding of the risks and complications of the procedure,⁶ and Vohra et al found that only 78% of cardiac surgery patients were informed about risk.⁸ Little is known about informed consent in patients who are candidates for AAA repair. One study evaluating post-operative functional status found that 18% of patients would not have had the operation if they had understood the difficulty of the recovery process,¹⁰ suggesting that informed consent was not adequate in these patients. Although we have previously reported surgeons' opinions on the content of informed consent for AAA repair,¹¹ no prior studies have explored the patient perspective on informed consent.

Assessing the degree to which patients are making informed choices requires an understanding of patients' perceptions as to the adequacy of the information conveyed by the surgeon and the quality of the surgeon-patient communication process.¹² Therefore, we sought to explore what information was important to patients deciding whether to have AAA repair, and to evaluate how effectively that information was conveyed during informed consent, in order to identify ways to improve the informed consent process. We conducted in-depth interviews with individual patients, because this qualitative approach is best-suited for examining complex phenomena that are difficult to measure quantitatively.¹³

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Methods 

Study design and sample 

We recruited patients with AAA who had undergone open repair or EVAR or declined surgical intervention in the previous three to six months at Yale-New Haven Hospital or the West Haven VA Hospital. We did not include patients who were not candidates for repair, as our objective was to better understand the decision-making process for patients dealing with a difficult choice. While effective communication of the natural history of AAA is important for all patients, patients who are not candidates for repair do not participate in an informed consent procedure.

Consistent with established qualitative research procedures, we drew a purposeful sample of ‘information rich’ participants¹⁴ from six different surgeons' practices in order to ensure representation of patients with a range of characteristics that are potentially relevant to AAA surgery decisions. Information rich participants are those who have direct experience with the phenomenon of interest and accordingly are able to provide unique insights. We varied the sample by education level in order to capture the experiences of patients with a range of intellectual capacity and ability to process the complex information involved in this decision-making process. We also included patients with a range of positive and negative clinical outcomes, since the nature of the postoperative course is likely to influence patients' perceptions of their decision-making process and the informed consent encounter. We asked patients whether another individual (such as a friend or family member) played a significant role in their decision-making process, and if so, the concluding segment of the interview included a supplemental interview with that individual. The final sample size was determined by the criterion of ‘theoretical saturation,' or the point at which no novel concepts emerge from subsequent interviews.¹⁵, ¹⁶ Sample size in qualitative studies varies depending on the breadth and complexity of the inquiry, although samples are generally smaller than those used in quantitative studies, and are examined more intensively. In this study, theoretical saturation was achieved upon completion of 20 interviews.

Qualitative approaches are becoming more common in clinical medicine and health services research.¹⁷, ¹⁸, ¹⁹, ²⁰ Qualitative studies seek to develop a richer understanding of various phenomena from in-depth analysis of a more limited number of cases, rather than to statistically test an a priori hypothesis using a representative sample from which one generalizes to the larger population.¹⁴, ²¹ Qualitative methods are ideally suited to generate hypotheses that might subsequently be tested on a larger population.¹³ As these methods do not quantify responses or test associations, descriptive and analytical statistics are not appropriate.

The research procedures were approved by the institutional review boards at the Yale University School of Medicine and the VA Connecticut Healthcare System, West Haven Campus.

Data collection 

We collected data through in-depth interviews, a qualitative research technique designed to elicit individual perceptions and experiences.¹⁴, ²² The interview used broad, open-ended, and non-directive questions to elicit detailed narratives from participants, and scripted probes as necessary.²³, ²⁴ Consistent with standard qualitative research techniques,¹⁴, ²² the interview guide (see appendix available online) evolved as interviews progressed through an iterative process to ensure that the questions captured all relevant emerging themes.

The primary investigator (LB) contacted all patients by mail, and with a follow-up phone call, and conducted all interviews in person. Where appropriate, family members were invited to join at the end of the session, at which time selected questions were repeated. Interviews were audio-taped and transcribed by a professional service. A questionnaire was administered at the close of the interview to obtain demographic information.

Data analysis 

We used the constant comparative method, a systematic data coding and analysis procedure.¹⁵, ²⁵, ²⁶ In this method, specific quotes from participants are categorized through an iterative process of assigning codes, or labels, for ideas expressed in the data. In the first phase (‘open coding’),¹⁵ researchers read transcripts line by line and assign codes to reflect emerging concepts. As subsequent transcripts are reviewed, code specifications are refined in order to fit the data. Each transcript is constantly compared with previously coded transcripts to ensure consistent interpretation and assignment of codes. The final code structure is then systematically reapplied to all transcripts in the data set. In the second phase of analysis (‘axial coding’), relationships among codes are examined in order to determine unifying elements across transcripts and across respondents. One form of output from qualitative analysis is themes, which are general propositions that emerge from diverse and detail-rich experiences of participants and provide recurrent ideas regarding the subject of inquiry.²⁷

Following the process recommended by experts in qualitative research,²⁷ our analytic team comprised three individuals from diverse backgrounds including surgery, qualitative and health services research, and medical decision-making. We coded all transcripts independently, and then in group sessions to resolve discrepancies through consensus. Our final code structure consisted of nine primary codes, with defined dimensions (or subcodes) for each. Codes included patients' perceptions related to choice, information, interactions with the surgeon, risks related to having surgery and not having surgery, fear and anticipation prior to surgery, experience with the recovery process relative to expectations, and the role of family members in decision-making. We used Atlas software (ATLAS.ti 5.0; ATLAS.ti Scientific Software Development, Berlin, Germany) to assist with management, coding, and analysis of data.²⁸

The following example illustrates the process of moving from codes to a unifying theme. During ‘open coding,' we noted substantive related but distinct concepts related to choice and perceptions of risk. Initially, the choice code was conceptualized simply as patient perception of whether or not a choice existed, and the risk code captured descriptions of the risks of surgery. As subsequent transcripts were reviewed, the choice concept revealed greater nuance, including patients' references to their role in making a choice, which ranged from feeling “guilty” or “coerced” to wanting to be a “good patient,” and the risk concept was expressed in the context of not having surgery as well as having surgery. These complexities were revealed through several iterations of defining the code properties. In axial coding, we reviewed all data assigned to the main codes ‘choice’ and 'perception of risk,' as we observed that patient expression of choice was consistently discussed in relation to their perceptions of attendant risk. These integrated data led to the development of the theme that patients did not appreciate the complexity of the choice as to whether or not to have surgery, but did recognize the choice between open surgery and EVAR.

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Results 

Of the 22 patients who were initially contacted for interviews, 20 agreed to participate. The characteristics of interview participants are shown in Table I. There were 12 patients who had open repair, 8 who had EVAR, and 1 who declined surgery. A total of 7 patients reported experiencing a complicated postoperative course (defined as having a complication which led to a prolonged hospital or intensive care unit (ICU) stay and substantially impacted overall recovery, for instance, myocardial infarction leading to prolonged ICU stay and recovery.)

Table I. Participant characteristics

Characteristic	Number (%)
Gender
Male	17(85%)
Female	3(15%)
Type of surgery
Open repair	11(55%)
EVAR	8(40%)
Declined surgery	1(5%)
Education
Less than high school	4(20%)
High school	9(45%)
College	4(20%)
Graduate/professional school	3(15%)
Marital status
Single	1(5%)
Married	13(65%)
Separated/divorced	3(15%)
Widowed	3(15%)
Employment status
Employed	3(15%)
Retired	16(80%)
Disabled	1(5%)
Surgeon practice setting
Academic	7(35%)
Private practice	3(15%)
VA	10(50%)
Interview participants
Patient alone	10(50%)
Patient with family	10(50%)
Post-operative course
Complicated	7(37%)
Uncomplicated	12(63%)

We identified four central themes (Table II) that characterize how patients with AAA experienced the informed consent process: 1) patients did not appreciate the scope of their options; 2) patients demonstrated that they were not adequately informed prior to making a decision; 3) patients differed in the scope and content of information they desired during informed consent; and 4) trust in the surgeon had an impact on the informed consent process. These themes emerged consistently in all but one interview, with the single discordant case being the one patient who refused surgery. Theme one did not apply to this patient, as he clearly perceived a choice as to whether or not to have surgery; however, his views are reflected in themes two, three, and four. All four of these themes do reflect the experiences of all patients who had surgery, including those with varying levels of education, positive and adverse clinical outcomes, and who were treated by each of the six surgeons.

Table II. Themes and sub-themes

1. Patients did not appreciate the scope of their options regarding whether or not to have surgery.

-There were misperceptions related to the natural history of AAA and the risks of surgery.

-Patients were aware of the choice between open and EVAR.

2. Patients demonstrated that they were not adequately informed prior to making a decision.

-Being inadequately informed had consequences ranging from opting out of the decision-making process to regret about the choice that was made.

3. Patients differed in the scope and content of information they desired.

-Family members played an important role in obtaining and processing information.

4. Trust in the surgeon had an impact on the informed consent process.

-Trust evolved in the context of disclosure of surgical risk as well as reassurance that the surgical outcome would be positive.

-Patients who expressed trust in the surgeon required less information and tended to defer to the surgeon in the decision-making process.

Theme #1: Patients did not appreciate the scope of their options 

Patients described feeling that there was no choice regarding whether or not to have surgery for their AAA. Upon learning about their diagnosis, they were terrified by the consequences of refusing surgery and saw surgery as their only option. For example, a 67-year-old man who had an open repair described his approach to the decision: “There was no other option other than the surgery. It was either that or live on a daily basis knowing that you could die at any second, and you can't live that way.”

Participants' opinions were often based on misperceptions about potential precipitants of rupture, or lack of knowledge of the risks related to the intervention. An example of the former is this 70-year-old female, who had an open repair and mistakenly believed that her regular daily activities might lead to rupture of the aneurysm: “I felt like all of a sudden I was going to bump into something, I'm just going to bleed out like a stuck pig, and it was terrifying.”

The patients who linked likelihood of rupture to individual behavior tended to lack understanding of the risks related to surgery. For instance, a 73-year-old man who had open repair said, “We felt like we're walking on eggshells for fear the thing would burst.” When asked about the risks of surgery, he responded, “I don't know. I said, hey, I got to have it done.”

Even those patients who perceived a choice regarding whether or not to have surgery lacked understanding of the complexity of this choice. An 82-year-old man who had an EVAR described his decision-making process and interaction with his surgeon: “He painted the picture very clean. He left me the choice to make. He told me the choices. He did not hold anything back. I could have refused the surgery. He would not have said anything … . He did not pressure me at all.” However, even in this case where the patient did perceive a choice, he clearly lacked understanding of the risks related to surgery: “[Surgery is] not really a risk. The risk was if I did not have it done.”

Although there was limited comprehension of the complexity of the choice as to whether or not to have surgery, patients did express understanding that in some cases, both endovascular and open surgery were options. Various reasons were cited for the preference for one approach over another. Patients favored open surgery because it was seen as a more permanent fix, whereas endovascular repair would require long-term follow-up and carried a higher risk of reintervention: “I would decide to have open surgery because the stent would cause me to go for additional treatment later on, and I want to get it over with. If my recovery is a little longer that is not of any vital concern anyway.”

Some patients were deterred by the postoperative surveillance that would be necessary after EVAR: “I would not choose the stent because it's not permanent and, you know, I would have to go every so many months to get it looked at and taken care of, as opposed to the open surgery, which is permanent.” In contrast, one patient preferred EVAR because he was actually comforted by the concept of long-term surveillance: “It is nice that he keeps checking every now and then to make sure the thing is still in place.”

Other patients chose EVAR because of concerns about the invasiveness of the open procedure: “I am just hoping they will do the stent and not the open surgery because that is a bit too much because of recovery time.”

Theme #2: Patients demonstrated that they were not adequately informed prior to making a decision 

Patients did not always feel adequately informed prior to making a decision regarding intervention. Some patients wanted to better understand the magnitude of risk associated with surgery and how risks could vary according to comorbidities, as illustrated by this 72-year-old man who had an open repair: “I was thinking well maybe I could have known what the odds say of waking up … Maybe I could have asked more questions along that line … that risk part of it, my age, and the fact that I am being treated for a heart condition.”

Other patients indicated they did not know what to expect, as demonstrated by this 82-year-old EVAR patient: “The heart doctor explained that because I have a blocked artery here so they might have to open an artery someplace up in here (points to neck) … . They had me pretty confused by the day I went in.”

Some patients wanted to know about the technical aspects of surgery, for example this 68-year-old man who had an EVAR: “I don't know how they did it. Technically, I'm sure that, you know, that's a doctor's point of view, but if there was something that would explain in more laymen's terms you know, what the procedure would be or how they did it … the not knowing what's going on is kind of difficult to handle.”

Others did perceive that they were adequately informed before undergoing surgery: “He took it from step one all the way through to the final step. He told us the risks, the benefits, and what the operation would consist of. He was very thorough.” However, even though this patient perceived that he was well-informed, he did not actually have a good understanding of risk, as illustrated by his response when asked if the surgeon told him about complications of the procedure: “No. He did not seem to think there was going to be any.”

There were substantial consequences when patients were not fully informed. Some patients opted out of the decision-making process because they did not feel that they had enough information to be able to participate: “Not being really knowledgeable of what the heck this all was all about I just put myself in their hands really because I didn't know what to ask.” Other patients expressed regret regarding their decision to undergo surgery, as they were unaware of a potential adverse outcome that they ultimately experienced, for example this patient who underwent EVAR: “There was a lot of stuff that I went through. I don't know if it was worth any of it but as I sit here right now, the trouble I've gone through, I question whether it was worth it or not.”

Theme #3: Patients differed in the scope and content of information they desired 

Some patients wanted to know extensive details about each of their options and the risks associated with each option: “There are some people that don't want to know anything. They don't want to know what your insides look like. We wanted to know everything. Where it was. What connected to what.” In contrast, others preferred less information, and in some cases chose to delegate the role of engaging in the informed consent process to a family member. For example, one 71-year-old man who had open repair stated, “At the time I really didn't want to know too much about [the risks of surgery] … Now my daughter was pretty good. My daughter was there, and there were some conversations that I didn't hear … As a patient I was probably better off not knowing all those things like, you're going to have dialysis.”

This patient's daughter also noted the importance of having support from family members during the informed consent process: “That's where the extra pair of ears and eyes come into the scenario. You need somebody else, so it isn't as stressful. You've got all this information coming at you and I think it's important to have someone, whether it be a patient advocate or a family member or someone you know, to not be alone for something like that.”

Theme #4: Trust had an impact on the informed consent process 

Patients' trust in their surgeon emerged as a central concept. There was variation in whether or not trust was present in the relationship, how it evolved over time, and how it impacted informed consent.

Some patients expressed that their trust in the surgeon had been established prior to the informed consent encounter: “We had done a lot of research before we ever went to [the hospital] and knew that [the surgeon] had a fabulous reputation. He had done a lot of the surgeries and that it was our philosophy that the person that had done three thousand versus three is where you want to get your experience.” Other patients' trust in the surgeon developed through the interpersonal interactions that occurred during informed consent: “I could see it in their eyes that they were concerned and they were, you know, they looked genuine, they had a genuine concern.”

In some cases, trust evolved as a result of effective communication of risks related to surgery: “Number one, I trusted the doctor. I had faith in him and he would tell you point blank. He explained everything and made me come back two or three times before it was done.” Other patients' trust resulted from the surgeon's confidence that the outcome of the surgery would be positive, as opposed to disclosure of the possibility of adverse events: “The doctor was a big factor in how he treated me and the way he explained it to my family and to me … . He didn't look down at me and say ‘Oh well you know this is going to be a serious surgery,' he said, ‘We’re going to fix you up. Don't worry about it. Everything is going to be fine,' and I kind of got the confidence in him that he was going to be able to do the job.”

Trust had an unexpected impact on the patient's role in informed consent. Some patients suggested that because they trusted their surgeon, they chose to defer to the surgeon during the informed consent discussion: “I just left it in their hands. I'm that kind of a person anyway. I have faith in them, you know?”

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Discussion 

In the case of AAA repair, informed consent should go beyond the traditional disclosure of risks, benefits, and alternatives to intervention. It should involve a two-way exchange of information during which surgeons confirm patients' understanding of the information that has been communicated, patients process the information and consider how each option fits in with their own values, and then a final decision is formulated jointly. In this way, the surgeon and patient mutually commit to a treatment plan.²⁹

This is the first study we are aware of which has investigated the patient's perspective on informed consent for AAA surgical repair. Using established research procedures,¹⁴, ¹⁵, ²² we characterized how patients approach AAA treatment decisions and identified areas of potential deficit in the nature, scope, and communication of information during informed consent that can be targeted for improvement.

We found that patients perceived that surgery was their only option. Some patients mistakenly believed that they had to “walk on eggshells” so as not to precipitate rupture, which led to an unfounded sense of urgency in their approach to the decision about surgery. Patients who have had a family member or friend die of a ruptured aneurysm may decide to have surgery even before they begin the informed consent discussion with their surgeon. This makes it difficult for surgeons to explain that non-intervention may be a reasonable course of action for patients who have such severe comorbidities that the aneurysm is not the primary threat to life, or are more likely to experience long-term disability following surgery.

Even though patients were unable to process the option of non-intervention, several patients expressed a preference for one surgery over another in a way that demonstrated that one option was more consistent with their individual values, such as having a greater capacity for tolerating risk, or valuing short-term risk over long-term risk. For example, a person who was afraid of the short-term risk of a long hospital course chose EVAR, while a different patient who was more concerned about long-term reintervention risk chose open surgery. This suggests that when adequately informed, patients are able to make choices that are consistent with their values.

We found that patients had a poor understanding of the potential risks related to surgery. Studies that have quantitatively examined the information that patients recall after informed consent for laparoscopic cholecystectomy,³ coronary artery bypass graft,⁴ joint replacement,⁷ and other vascular procedures⁶ have found similar gaps regarding knowledge about risk. In all studies of informed consent, lack of knowledge may be related to poor recall, but in the case of AAA, it is also possible that patients who have already made a decision to have surgery are less likely to be open to hearing information about potential complications. This hypothesis is supported by the minimization or complete dismissal of risk that was verbalized during the interviews, as well as the surprise and disappointment voiced by those who had experienced adverse events.

The importance of open exchange of information during informed consent should be interpreted with caution, as we found that there was substantial variation in the amount of information desired by individual patients prior to making a decision. It is difficult to convey information about risk and non-intervention when patients are experiencing high levels of anxiety about their diagnosis. In these fairly unique circumstances, patients may be unable to process complex information about their options and formulate appropriate questions. Family members were felt to be invaluable participants in informed consent, as they were able to provide support and process information when patients were overwhelmed by the stress of the situation.

Informed consent can be seen as an opportunity for surgeons to gain the trust of their patients. Patients' level of trust had important implications regarding their role in the informed consent process. Some patients stated that because they trusted their surgeon, they required less information. In contrast, other patients who expressed a lack of trust in their surgeon chose to seek more information through a second opinion. This inverse relationship between degree of trust and preference for information is not necessarily intuitive, but it has been described in other studies.³⁰, ³¹ Although it is essential for surgeons to gain trust during informed consent, it is important to be aware that patients' trust in the surgeon may lead to a decreased desire for information which can result in inaccurate expectations and dissatisfaction with outcomes.

We designed this study in order to explore patients' perspectives on the AAA decision-making process and generate hypotheses about how this process might be improved. In order to facilitate candid responses, we conducted the interviews in person, in locations and at times determined by the patient, and used specific techniques for in-depth interviewing. We used several recommended strategies to ensure the reliability of the data, including use of an interview guide and independent transcription service, standardized coding and analysis of data, and maintenance of an audit trail to document analytic decisions.³² However, findings should be considered in light of several limitations. All of the patients who were interviewed were seen by one of six surgeons and were treated at one of two hospitals, so these findings may not apply to patients in other settings. This qualitative study is intentionally descriptive in nature, proposing themes that characterize the experiences of patients contemplating AAA repair. Further quantitative studies are needed to determine the prevalence of views expressed in these interviews among patients at large, or to make associations between patient characteristics (for example, age, gender, level of education, or postoperative experience) or surgeon-related characteristics (variation in content and presentation of information) and patient views on informed consent.

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Conclusion 

The themes that were raised in these interviews point to several ways in which the process of informed consent for patients who are candidates for AAA repair might be improved.

First, patients' misperceptions about the nature of death from a ruptured aneurysm should be corrected, and the sense of urgency removed from the decision. Second, a baseline amount of information about the risks of intervention should be communicated clearly and consistently to patients and, if possible, family members, with the flexibility of providing more information as desired. Open communication about risk not only adheres to the principles of informed consent but also may build patients' trust in their surgeon. Furthermore, encouraging a two-way exchange of information facilitates the process of ensuring patients' adequate comprehension of risk and allows patients to express their unique values so that the surgeon can help to decide which option would be most appropriate for them.

Overall, our research emphasizes that the art of communication and understanding the needs of a particular patient and family are essential to obtaining adequate informed consent, so that knowledge of medical fact can be combined with patients' expressions of what is most important to them. Adapting the informed consent encounter to incorporate the patient's perspective is critical in order to ensure that the decision regarding AAA repair is consistent with the patient's informed preference.

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Author contribution 

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We gratefully acknowledge Penny Vasilas, RN, for her assistance with development of the interview guide and patient recruitment at the West Haven VA Hospital.

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Appendix. Interview guide (online only) 

We asked questions 1 through 9 with the patient alone, then we repeated questions 5 through 9 with family present. For patients who declined surgery, we skipped questions 7 and 8.

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References 

1. Brewster DC, Cronenwett JL, Hallett JW, Johnston KW, Krupski WC, Matsumura JS. Guidelines for the treatment of abdominal aortic aneurysms (Report of a subcommittee of the Joint Council of the American Association for Vascular Surgery and Society for Vascular Surgery). J Vasc Surg. 2003;37:1106–1117
   • View In Article
   • Abstract
   • Full Text
   • Full-Text PDF (23 KB)
   • CrossRef
2. Beauchamp T, Childress J. Principles of biomedical ethics. 5th ed.. New York, NY: Oxford University Press; 2001;
   • View In Article
3. Whitney SN, McGuire AL, McCullough LB. A typology of shared decision making, informed consent, and simple consent. Ann Intern Med. 2004;140:54–59
   • View In Article
4. Kriwanek S, Armbruster C, Beckerhinn P, Blauensteier W, Gschwantler M. Patients' assessment and recall of surgical information after laparoscopic cholecystectomy. Dig Surg. 1998;15:669–673
   • View In Article
   • MEDLINE
   • CrossRef
5. Mishra PK, Ozalp F, Gardner RS, Arangannal A, Murday A. Informed consent in cardiac surgery: is it truly informed?. J Cardiovasc Med (Hagerstown). 2006;7:675–681
   • View In Article
   • MEDLINE
   • CrossRef
6. Stanley BM, Walters DJ, Maddern GJ. Informed consent: how much information is enough?. Aust N Z J Surg. 1998;68:788–791
   • View In Article
   • MEDLINE
7. Turner P, Williams C. Informed consent: patients listen and read, but what information do they retain?. N Z Med J. 2002;115:U218
   • View In Article
8. 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;11:64–69
   • View In Article
   • MEDLINE
   • CrossRef
9. Braddock CH, Edwards KA, Hasenberg NM, Laidley TL, Levinson W. Informed decision making in outpatient practice: time to get back to basics. JAMA. 1999;282:2313–2320
   • View In Article
   • MEDLINE
   • CrossRef
10. Williamson WK, Nicoloff AD, Taylor LM, Moneta GL, Landry GJ, Porter JM. Functional outcome after open repair of abdominal aortic aneurysm. J Vasc Surg. 2001;33:913–920
    • View In Article
    • Abstract
    • Full Text
    • Full-Text PDF (76 KB)
    • CrossRef
11. 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;47:287–295
    • View In Article
    • Abstract
    • Full Text
    • Full-Text PDF (108 KB)
    • CrossRef
12. Kasper JF, Mulley AG, Wennberg JE. Developing shared decision-making programs to improve the quality of health care. QRB Qual Rev Bull. 1992;18:183–190
    • View In Article
    • MEDLINE
13. Malterud K. The art and science of clinical knowledge: evidence beyond measures and numbers. Lancet. 2001;358:397–400
    • View In Article
    • Abstract
    • Full Text
    • Full-Text PDF (66 KB)
    • CrossRef
14. Patton M. Qualitative research and methods. Thousand Oaks, CA: Sage Publications; 2002;
    • View In Article
15. Glaser BG, Strauss AL. The discovery of grounded theory: Strategies for qualitative research. Chicago: Aldine; 1967;
    • View In Article
16. Morse J. The significance of saturation. Qual Health Res. 1995;5:147–149
    • View In Article
    • CrossRef
17. McKibbon KA, Gadd CS. A quantitative analysis of qualitative studies in clinical journals for the 2000 publishing year. BMC Med Inform Decis Mak. 2004;4:11
    • View In Article
    • MEDLINE
    • CrossRef
18. McKinlay JB, Marceau LD. To boldly go. Am J Public Health. 2000;90:25–33
    • View In Article
    • MEDLINE
    • CrossRef
19. Shortell SM. The emergence of qualitative methods in health services research. Health Serv Res. 1999;34:1083–1090
    • View In Article
    • MEDLINE
20. Sinuff T, Cook DJ, Giacomini M. How qualitative research can contribute to research in the intensive care unit. J Crit Care. 2007;22:104–111
    • View In Article
    • Abstract
    • Full Text
    • Full-Text PDF (228 KB)
    • CrossRef
21. Pope C, Mays N. Reaching the parts other methods cannot reach: an introduction to qualitative methods in health and health services research. BMJ. 1995;311:42–45
    • View In Article
    • MEDLINE
    • CrossRef
22. Britten N. Qualitative interviews in medical research. BMJ. 1995;311:251–253
    • View In Article
    • MEDLINE
    • CrossRef
23. Crabtree B, Miller W. Doing qualitative research. 2nd Ed.. Thousand Oaks, CA: Sage Publications; 1999;
    • View In Article
24. Merton RK, Fiske M, Kendall P. The focused interview: a manual of problems and procedures. Glencoe: Free Press; 1990;
    • View In Article
25. Miles MB, Huberman AM. Qualitative data analysis: an expanded sourcebook. 2nd ed.. Thousand Oaks, CA: Sage Publications; 1994;
    • View In Article
26. Strauss AL, Corbin J. Basics of qualitative research: grounded theory procedures and techniques. London: Sage Publications; 1998;
    • View In Article
27. Bradley EH, Curry LA, Devers KJ. Qualitative data analysis for health services research: developing taxonomy, themes, and theory. Health Serv Res. 2007;42:1758–1772
    • View In Article
    • CrossRef
28. Muhr T. User's Manual for ATLAS.ti. 5.0 [computer program]. Version 5 Berlin, Germany: Scientific Software Development GmbH; 2004;
    • View In Article
29. Widdershoven GA, Verheggen FW. Improving informed consent by implementing shared decisionmaking in health care. IRB. 1999;21:1–5
    • View In Article
    • MEDLINE
    • CrossRef
30. Fraenkel L, McGraw S. What are the essential elements to enable patient participation in medical decision making?. J Gen Intern Med. 2007;22:614–619
    • View In Article
    • CrossRef
31. Kraetschmer N, Sharpe N, Urowitz S, Deber RB. How does trust affect patient preferences for participation in decision-making?. Health Expect. 2004;7:317–326
    • View In Article
    • MEDLINE
    • CrossRef
32. Mays N, Pope C. Rigour and qualitative research. BMJ. 1995;311:109–112
    • View In Article
    • MEDLINE
    • CrossRef