ORIGINAL ARTICLE
Preoperative concerns of patients undergoing endoscopic sinus surgery Jeffrey C. Yeung, MD1 , Michael G. Brandt, MD, FRCSC2 , Jason H. Franklin, MD, FRCSC3 , Philip C. Doyle, PhD4,5 , Brian W. Rotenberg, MD, MPH, FRCSC4 and Shaun J. Kilty, MD, FRCSC1,6
Background: Patient-centered care is recognized as being fundamental to successful medical practice. The effectiveness of patient-centered care has classically been measured by posreatment outcomes, such as patient compliance and psychosocial responses. Systematic assessment of patient concerns prior to treatment has been limited, to date. Endoscopic sinus surgery (ESS) is an elective procedure for chronic rhinosinusitis that carries a clear, defined set of risks. The objective of this prospective observational study was to determine the concerns of patients undergoing ESS for chronic rhinosinusitis.
as the wait time for surgery. Patients were least concerned about psychological factors (mean = 1.8/9). No differences with respect to age or gender were identified. Mean scores for cerebrospinal fluid leak and orbital injury were 3 and 3.2, respectively.
Methods: A total of 180 patients undergoing ESS for chronic rhinosinusitis with or without polyposis were recruited at 2 Canadian tertiary care centers. They completed a validated survey assessing their concerns regarding the risks and outcomes of surgery. Data was analyzed using descriptive statistics and analysis of variance.
2014 ARS-AAOA, LLC.
Results: Patients had a low degree of concern prior to undergoing surgery (overall score 2.8/9), though individual variability existed. Subjects felt the greatest level of concern regarding potential need for revision surgery as well
1 Department
of Otolaryngology–Head and Neck Surgery, The University of Ottawa, Ottawa, ON, Canada; 2 Department of Otolaryngology–Head and Neck Surgery, University of Toronto, Toronto, ON, Canada; 3 Department of Otolaryngology, Queen’s University, Kingston, ON, Canada; 4 Department of Otolaryngology–Head and Neck Surgery, Western University, London, ON, Canada; 5 Laboratory for Quality of Life and Well-Being, Rehabilitation Sciences, Western University, London, ON, Canada; 6 The Ottawa Hospital Research Institute (OHRI), Ottawa, ON, Canada Correspondence to: Shaun J. Kilty, MD, FRCSC, Department of Otolaryngology–Head and Neck Surgery, Ottawa Hospital, Civic Campus, Parkdale Clinic, Room 458, 1053 Carling Ave., Ottawa, ON, Canada; e-mail: [email protected] Potential conflict of interest: None provided. Presented at the Annual Meeting of the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNSF), September 29-October 2, 2013, Vancouver, Canada. Received: 12 February 2014; Revised: 9 March 2014; Accepted: 11 March 2014 DOI: 10.1002/alr.21330 View this article online at wileyonlinelibrary.com.
Conclusion: Patients’ level of concern prior to undergoing elective surgery is generally low. Patients’ areas of greatest concern may not align with those perceived by the physician. This study provides insight into patient concerns prior to undergoing elective sinus surgery and emphasizes the C importance of the patient-centered approach to care.
Key Words: computational fluid dynamics (CFD); computer modeling for nasal airflow; chronic rhinosinusitis How to Cite this Article: Yeung JC, Brandt MG, Franklin JH, Doyle PC, Rotenberg BW, Kilty SJ, Preoperative concerns of patients undergoing endoscopic sinus surgery. Int Forum Allergy Rhinol. 2014;4:658–662.
C
hronic rhinosinusitis (CRS) is a prevalent condition that causes significant morbidity.1 The Center for Disease Control and Prevention estimates that 29.6 million individuals in the United States are affected by CRS, resulting in 11.7 million physician visits annually.2 Since its popularization in the 1980s, endoscopic sinus surgery (ESS) has become the primary management tool for medically resistant CRS. ESS is very effective for symptom management and improving patient quality of life, and as such has become 1 of the most common procedures performed in Otolaryngology–Head and Neck Surgery.1 Accurate and complete communication of the benefits and risks of ESS during the patient informed-consent process is critical. It empowers the patient to take part in their own treatment decision-making and fosters a positive therapeutic relationship between the physician and patient.3 Further, it creates an environment where a patient’s questions and concerns can be addressed in a direct and open manner. Effective physician-patient communication has been
International Forum of Allergy & Rhinology, Vol. 4, No. 8, August 2014
658
Sinus surgery patient preoperative concerns
shown to improve both physiological and psychological outcomes.4 In seeking to further understand a patient’s concerns regarding surgery, one needs to consider a variety of factors, including an individual’s background, education, experiences, as well as their inherent responses to information regarding risks and complications. Additionally, a patient’s concerns may be very divergent from those of their physician. However, systematic evaluation of patient concerns leading up to surgery has, to date, not been well studied. Thus, the present study sought to evaluate the preoperative concerns of patients undergoing ESS for CRS with or without polyps and to determine which concerns were most prevalent in this patient population. This data provides insight into patient perspectives about their concerns regarding ESS as well as serving to facilitate discussion surrounding informed clinical decision-making in this setting.
otolaryngologists (S.J.K. for Ottawa and B.W.R. for London) conducted all the conversations using layperson vocabulary, based on their respective training and experience. For both surgeons, this included the following items. First, the planned procedure and its purpose were described, including the expected length, anesthesia requirements, and details of postoperative care and ongoing topical therapy. The nature of major uncommon complications (orbital injury and cerebrospinal fluid leak) and minor complications (bleeding, nasal packing, pain, headache, need for revision) were then explained to the patient. Finally, any outstanding patient questions were addressed. The patient was then approached to participate in this study. All surgical candidates, regardless of whether or not they decided to proceed with ESS, were recruited. All survey data was collected anonymously along with demographic information.
Outcome measure
Patients and methods Study design The study design consisted of a prospective observational study.
Study population Patients were recruited from the rhinology clinics of 2 tertiary care referral centers: St. Joseph’s Health Care (London, ON, Canada) and The Ottawa Hospital (Ottawa, ON, Canada). Consecutive patients diagnosed with medically resistant CRS (with or without nasal polyps) as per the 2011 Canadian Rhinosinusitis Guidelines were recruited into this study.5 English-speaking patients age >18 years were included. Patients who had previously undergone ESS were excluded. This study received ethics approval from the Ottawa Hospital Research Institute (REB #2011680) and Western University Health Sciences Research Ethics Board (Review #13772E).
Survey All patients completed a previously validated questionnaire: the Western Surgical Concern Inventory–Endoscopic Sinus Surgery (WSCI) questionnaire.6 The WSCI questionnaire surveys patients regarding 4 areas of potential areas of concern: general surgical, ESS-specific, psychosocial, and wait time concerns. The questionnaire consists of 19 questions in total (6, 7, 5, and 1 questions in each of the 4 categories, respectively). Patients are asked to rate their degree of concern on a 9-point Likert scale with descriptors for odd-numbered scores: 9 on this scale corresponded to “major concerns”; 7 to “many concerns”; 5 to “moderate concerns”; 3 to “very few concerns”; and 1 to “no concerns.”
Survey administration Patients were approached regarding study participation after the risks and benefits of ESS were discussed. Two staff
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International Forum of Allergy & Rhinology, Vol. 4, No. 8, August 2014
The primary outcome measure consisted of the WSCI questionnaire data.
Statistical analysis Descriptive statistics were employed for our analysis of scaled responses to the questions posed in the questionnaire. For comparison, the questions were subdivided into their 4 respective categories for analysis (general, ESS-specific, psychosocial, and wait time). Mean scores were used for each category. Data were also stratified in a binary fashion for analysis; scores between 5 (moderate concern) to 9 (major concerns) were considered to be a significant level of concern. Comparisons between various subgroups were made using an analysis of variance.
Results A total of 180 patients completed the WSCI questionnaire; 103 respondents were from the Ottawa site and 77 were from the London site. The mean ± standard deviation (SD) age of participants was 52.3 ± 14.9 years. Forty-two percent (42%) of participants (76 individuals) were female. The response rate for questions was 97.7% to 100% (177180 responses per question). Unanswered questions were not included in the analysis. On average, participants exhibited very few concerns regarding all aspects of surgery, with a mean overall scaled score of 2.8. The response range for the majority of questions used the entire scale from 1 to 9. The proportion of respondents who reported a mean concern of 5 or greater was 21%. The mean proportion of respondents in each of the 4 subcategories with average concern score of 5 or greater were as follows: general surgical, 25%; ESS-specific, 27%; psychosocial, 6%; and wait time, 32%. The areas found to be most concerning to the participants were as follows: (1) primary problem not fixed by surgery, 3.7 ± 2.1; (2) need for revision surgery, 3.4 ± 2; (3) general
Yeung et al.
FIGURE 1. Mean preoperative concerns by institution.
surgical complication, 3.4 ± 1.7; and (4) wait time for surgery, 3.4 ± 2.4. Participants reported the least amount of concern regarding psychosocial issues surrounding surgery. Breakdown of preoperative concern by question and site are described in Figure 1. Summary statistics for all questions are described in Table 1. The mean overall scores for each category were as follows: (1) general surgical concern, 3.0 ± 0.4; (2) ESSspecific concerns, 3.1 ± 0.4; (3) psychosocial concerns, 1.8 ± 0.2; and (4) surgical wait time, 3.4 ± 2.4. Pairwise comparison revealed a statistically significant difference between concerns about surgical complications (both general and ESS-specific) and psychosocial (p < 0.0001) and wait time concerns (p = 0.0054). These differences remained when the data were adjusted for age and gender (Table 2). However, no statistically significant differences in overall concern were observed for either age or gender. The difference between concerns reported by patients in Ottawa vs those in London was found to be statistically significant (p = 0.0205). Patients from London were most concerned about anesthetic risk (2.5 ± 2.6) and need for revision surgery (3.5 ± 2.1). In contrast, patients from Ottawa were most concerned about failure to correct symptoms (4.1 ± 2.1) and surgical wait time (3.9 ± 2.4).
Discussion CRS can be a burdensome disease that significantly impairs one’s perceived quality of life. Patients suffering from CRS were previously found to have similar self-perceived health status as those with asthma, arthritis, cancer, and
TABLE 1. Summary statistics Question
n
Missing (n) Mean SD Minimum Maximum
Surgical complication
179
1
3.4
1.7
1
8
Anesthetic
179
1
3.2
2.3
1
9
Daily activities
179
1
2.6
1.9
1
9
Pain and discomfort
180
0
3.3
1.9
1
9
Resume work
180
0
3.1
2.1
1
9
Burden
179
1
2.4
1.6
1
9
Nasal breathing
180
0
2.8
1.8
1
9
Problem not fixed
178
2
3.7
2.1
1
9
Epistaxis
178
2
3.1
1.9
1
9
Revision surgery
178
2
3.4
2
1
9
Packing
176
4
2.9
2
1
9
Cerebrospinal fluid leak 177
3
3
2.2
1
9
Eye injury
177
3
3.2
2.1
1
9
Embarrassed
176
4
1.9
1.5
1
9
Depressed
178
2
1.7
1.3
1
7
Social activities
179
1
1.9
1.4
1
9
Judged
179
1
1.5
1.1
1
7
Questions answered
179
1
1.9
1.4
1
9
Wait time
179
1
3.4
2.4
1
9
SD = standard deviation.
International Forum of Allergy & Rhinology, Vol. 4, No. 8, August 2014
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Sinus surgery patient preoperative concerns
TABLE 2. Age-adjusted and gender-adjusted pairwise
comparison of the 4 WSCI categoriesa
General surgical ESS-specific Psychosocial
ESS-specific
Psychosocial
Wait time
0.6266
< 0.0001
0.0054
< 0.0001
0.1485 < 0.0001
a Patients demonstrated significantly different degree of concern for psychosocial aspects of surgery vs those related to surgery. Bold values are significant. ESS = endoscopic sinus surgery; WSCI = Western Surgical Concern Inventory– Endoscopic Sinus Surgery.
inflammatory bowel disease.7 CRS, however, is not a lifethreatening disease. Therefore, CRS patients have a fundamentally different set of considerations when deciding on surgery when compared to patients with potentially lifethreatening diseases. Furthermore, ESS is an ideal procedure to study due to its well-defined set of risks and complications. The current study is the first to systematically assess the considerations and concerns in this particular group of patients and provides normative data on patient concerns based on current practices for providing informed consent. Overall, patients appeared to have a low degree of preoperative concern prior to undergoing ESS. Approximately three-quarters of patients rated their concerns at 4 or below for a majority of concerns addressed within the WSCI questionnaire, corresponding to very few concerns. The degree of concern did not vary by gender or by age. Patients expect a comprehensive discussion surrounding all risks of ESS, regardless of severity or rarity.8, 9 The current findings suggest that following such discussion surrounding risks and benefits of ESS, the majority of patients have few concerns about specific aspects and complications of ESS. This indicates that the physician’s capacity to clearly and directly identify and discuss the potential risks of this specific procedure, ESS, may in and of itself serve to substantially reduce anticipatory anxiety prior to surgery. As a result, this level of communication may also facilitate a more open dialogue between the patient and the physician in the postoperative period. Further, it may also lead to reduced postoperative pain, distress, and disability that is associated with patient anxiety.10 In this study, patients exhibited the greatest degree of concern regarding whether or not ESS would relieve their symptoms (problem not fixed and a need for revision surgery (OR)). Based on the present data, we did not identify a single category of risks that patients found particularly concerning. Psychological concerns (such as feeling judged or embarrassed about surgery) appeared to be minimally concerning for patients undergoing ESS. This finding is of importance, as the psychological morbidity in patients suffering from CRS may differ from those of other chronic illnesses, such as inflammatory bowel disease.11 Lending to this finding may be the fact that the surgery is performed
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International Forum of Allergy & Rhinology, Vol. 4, No. 8, August 2014
with endoscopic techniques, thus there are no overt signs of having undergone a sinus surgical treatment, nor any external signs of the disease being present. Interestingly, severe yet rare complications such as orbital injury and cerebrospinal fluid leak were not causes of increased concern. This finding is likely explained by the study methodology, whereby the WSCI Questionnaire was administered following the solicitation of informed consent. This suggests that the incidence of rare but ominous complications does not, in general, deter patients from pursuing ESS for treatment of their CRS. Thus, it would appear that when presented with comprehensive information on potential complications, patients are able to evaluate the risk:benefit of the procedure in an informed manner. Alternatively, it may suggest that patients simply do not comprehend the severity of major complications despite prior discussion with the surgeon. This is in keeping with data from a similar study on diagnostic thyroid surgery where patients were found to be most concerned about their thyroid nodules harboring malignancy, more so than the rare ominous complications of thyroid surgery itself.12 These hypotheses warrant further study. Individual variability in responses was observed in the data as evidenced by the broad range of responses. Nevertheless, only a small proportion of patients reported significant degrees of concern (representing the entire range of the Likert scale). When these patients’ questionnaires were examined, a more pronounced difference in areas of concern between institutions was observed. In this study, 2 staff physicians conducted all conversations regarding informed consent and the data suggest that some degree of information bias does indeed exist. Topics covered during informed consent discussion were, however, largely the same between the 2 surgeons. While these variations may not affect the majority of patients, individual variation in physician-led discussion may affect the perspectives of “high anxiety” patients differently. These findings also indicate that a subset of CRS patients may require additional counseling prior to surgery. Though investigating the determinants of patient concern/anxiety was outside the scope of this study, the present findings would suggest that other factors may influence perceived concerns of, and the responses provided by patients. For example, the time that is required for such information provision may be a key factor relative to easing a patient’s level of anxiety. Past research suggest that providing adequate time for patient-physician communication may result in increased levels of patient satisfaction with the care they receive.13 Therefore, presentation of information must also be followed by an opportunity for the patient to ask questions, for specific information to be discussed in more detail or clarified, or quite frankly, to permit the patient the chance to not feel “rushed” in making their decision or in seeking further information. Additionally, disease-specific factors (ie, nasal polyposis increases the risk of requiring revision surgery) as well as comorbid conditions (ie, cardiac history increases the risk of undergoing general anesthetic) may influence preoperative
Yeung et al.
concerns of individual patients and warrants further investigation. Patients’ relatively strong concerns regarding the wait time for their sinus surgery is of relevance. It speaks to the status of surgical wait times in a publicly funded healthcare system (Ontario, Canada). While ESS is not a lifesaving surgery, patients do indeed suffer increased morbidity through a lack of disease control as a result of wait times for surgical therapy. Naturally, their concerns regarding accessibility to care is reflected in the data and even exceed perceived concerns relative to the potentially severe complications of ESS. These patients are also likely sensitized to the issue of waiting months for surgery given the wait times they have incurred leading up to the intervention. In Canada, referral to an otolaryngologist is associated with a significant wait time, notwithstanding the time to diagnosis of CRS and time required to undergo a computed tomography (CT) scan of the paranasal sinuses prior to surgery. Exploring differences in expectations and concerns of patients who have access to a privately funded healthcare system would be of interest. In the present study design, the WSCI questionnaire was purposefully administered following the informed consent conversation between patient and physician. This ensured the accuracy and completeness of information available to the patient prior to inquiring about their concerns. However, this methodology also potentially left patient re-
sponses susceptible to information bias due to stylistic variations by which each surgeon presented information. Furthermore, patient concern may vary significantly based on how the information is presented. Certainly, these limitations may explain the unexpectedly low degree of concerns identified by this study. Additionally, this study does not address the retention of information following physicianpatient encounters.
Conclusion This is the first study to systematically characterize the preoperative concerns of patients undergoing ESS in a large sample. The results demonstrate that following the informed consent process, the majority of patients do not exhibit major concerns prior to undergoing ESS. Further, our data suggest a discrepancy between physician concerns, which typically involve severe complications, and those of the patient. This study provides normative data and will permit future investigation into factors that increase or decrease preoperative concern as well as the determination of variations in patient concern over time. Additionally, further exploration of issues related to optimizing the time requirement of information provision and its potential impact on patient perception is warranted. Collectively, such information will aid in tailoring conversations surrounding informed consent and providing individualized care.
References 1.
2.
3.
4.
5.
Soler ZM, Wittenberg E, Schlosser RJ, Mace JC, Smith TL. Health state utility values in patients undergoing endoscopic sinus surgery. Laryngoscope. 2011;121:2672–2678. Schiller JS, Lucas JW, Ward BW, Peregoy JA. Summary health statistics for U.S. adults: National Health Interview Survey, 2010. Vital Health Stat 10. 2012;(252):1–207. Charles C, Gafni A, Whelan T. Decision-making in the physician-patient encounter: revisiting the shared treatment decision-making model. Soc Sci Med. 1999;49:651–661. Stewart MA. Effective physician-patient communication and health outcomes: a review. CMAJ. 1995;152:1423–1433. Desrosiers M, Evans GA, Keith PK, et al. Canadian clinical practice guidelines for acute and chronic
6.
7.
8.
9.
rhinosinusitis. Allergy Asthma Clin Immunol. 2011; 7:2. Brandt MG, Rotenberg BW, Yeung JC, Franklin JH, Doyle PC. Prospective evaluation of preoperative concern among patients considering endoscopic sinus surgery: initial validation. Int Forum Allergy Rhinol. 2011;1:219–224. Macdonald KI, McNally JD, Massoud E. The health and resource utilization of Canadians with chronic rhinosinusitis. Laryngoscope. 2009;119:184–189. Bowden MT, Church CA, Chiu AG, Vaughan WC. Informed consent in functional endoscopic sinus surgery: the patient’s perspective. Otolaryngol Head Neck Surg. 2004;131:126–132. Wolf JS, Chiu AG, Palmer JN, et al. Informed consent in endoscopic sinus surgery: the patient perspective. Laryngoscope. 2005;115:492–494.
10. Crockett JK, Gumley A, Longmate A. The development and validation of the Pre-operative Intrusive Thoughts Inventory (PITI). Anaesthesia. 2007;62:683–689. 11. Rochelle TL, Fidler H. The importance of illness perceptions, quality of life and psychological status in patients with ulcerative colitis and Crohn’s disease. J Health Psychol. 2013;18:972– 983. 12. Brandt MG, Franklin JH, Osborn HA, et al. The Western Surgical Concern Inventory-Thyroid: development and initial validation. Otolaryngol Head Neck Surg. 2012;147:227–232. 13. Lin CT, Albertson GA, Schilling LM, et al. Is patients’ perception of time spent with the physician a determinant of ambulatory patient satisfaction? Arch Intern Med. 2001;161:1437–1442.
International Forum of Allergy & Rhinology, Vol. 4, No. 8, August 2014
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Preoperative concerns of patients undergoing endoscopic sinus surgery Jeffrey C. Yeung, MD1 , Michael G. Brandt, MD, FRCSC2 , Jason H. Franklin, MD, FRCSC3 , Philip C. Doyle, PhD4,5 , Brian W. Rotenberg, MD, MPH, FRCSC4 and Shaun J. Kilty, MD, FRCSC1,6
Background: Patient-centered care is recognized as being fundamental to successful medical practice. The effectiveness of patient-centered care has classically been measured by posreatment outcomes, such as patient compliance and psychosocial responses. Systematic assessment of patient concerns prior to treatment has been limited, to date. Endoscopic sinus surgery (ESS) is an elective procedure for chronic rhinosinusitis that carries a clear, defined set of risks. The objective of this prospective observational study was to determine the concerns of patients undergoing ESS for chronic rhinosinusitis.
as the wait time for surgery. Patients were least concerned about psychological factors (mean = 1.8/9). No differences with respect to age or gender were identified. Mean scores for cerebrospinal fluid leak and orbital injury were 3 and 3.2, respectively.
Methods: A total of 180 patients undergoing ESS for chronic rhinosinusitis with or without polyposis were recruited at 2 Canadian tertiary care centers. They completed a validated survey assessing their concerns regarding the risks and outcomes of surgery. Data was analyzed using descriptive statistics and analysis of variance.
2014 ARS-AAOA, LLC.
Results: Patients had a low degree of concern prior to undergoing surgery (overall score 2.8/9), though individual variability existed. Subjects felt the greatest level of concern regarding potential need for revision surgery as well
1 Department
of Otolaryngology–Head and Neck Surgery, The University of Ottawa, Ottawa, ON, Canada; 2 Department of Otolaryngology–Head and Neck Surgery, University of Toronto, Toronto, ON, Canada; 3 Department of Otolaryngology, Queen’s University, Kingston, ON, Canada; 4 Department of Otolaryngology–Head and Neck Surgery, Western University, London, ON, Canada; 5 Laboratory for Quality of Life and Well-Being, Rehabilitation Sciences, Western University, London, ON, Canada; 6 The Ottawa Hospital Research Institute (OHRI), Ottawa, ON, Canada Correspondence to: Shaun J. Kilty, MD, FRCSC, Department of Otolaryngology–Head and Neck Surgery, Ottawa Hospital, Civic Campus, Parkdale Clinic, Room 458, 1053 Carling Ave., Ottawa, ON, Canada; e-mail: [email protected] Potential conflict of interest: None provided. Presented at the Annual Meeting of the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNSF), September 29-October 2, 2013, Vancouver, Canada. Received: 12 February 2014; Revised: 9 March 2014; Accepted: 11 March 2014 DOI: 10.1002/alr.21330 View this article online at wileyonlinelibrary.com.
Conclusion: Patients’ level of concern prior to undergoing elective surgery is generally low. Patients’ areas of greatest concern may not align with those perceived by the physician. This study provides insight into patient concerns prior to undergoing elective sinus surgery and emphasizes the C importance of the patient-centered approach to care.
Key Words: computational fluid dynamics (CFD); computer modeling for nasal airflow; chronic rhinosinusitis How to Cite this Article: Yeung JC, Brandt MG, Franklin JH, Doyle PC, Rotenberg BW, Kilty SJ, Preoperative concerns of patients undergoing endoscopic sinus surgery. Int Forum Allergy Rhinol. 2014;4:658–662.
C
hronic rhinosinusitis (CRS) is a prevalent condition that causes significant morbidity.1 The Center for Disease Control and Prevention estimates that 29.6 million individuals in the United States are affected by CRS, resulting in 11.7 million physician visits annually.2 Since its popularization in the 1980s, endoscopic sinus surgery (ESS) has become the primary management tool for medically resistant CRS. ESS is very effective for symptom management and improving patient quality of life, and as such has become 1 of the most common procedures performed in Otolaryngology–Head and Neck Surgery.1 Accurate and complete communication of the benefits and risks of ESS during the patient informed-consent process is critical. It empowers the patient to take part in their own treatment decision-making and fosters a positive therapeutic relationship between the physician and patient.3 Further, it creates an environment where a patient’s questions and concerns can be addressed in a direct and open manner. Effective physician-patient communication has been
International Forum of Allergy & Rhinology, Vol. 4, No. 8, August 2014
658
Sinus surgery patient preoperative concerns
shown to improve both physiological and psychological outcomes.4 In seeking to further understand a patient’s concerns regarding surgery, one needs to consider a variety of factors, including an individual’s background, education, experiences, as well as their inherent responses to information regarding risks and complications. Additionally, a patient’s concerns may be very divergent from those of their physician. However, systematic evaluation of patient concerns leading up to surgery has, to date, not been well studied. Thus, the present study sought to evaluate the preoperative concerns of patients undergoing ESS for CRS with or without polyps and to determine which concerns were most prevalent in this patient population. This data provides insight into patient perspectives about their concerns regarding ESS as well as serving to facilitate discussion surrounding informed clinical decision-making in this setting.
otolaryngologists (S.J.K. for Ottawa and B.W.R. for London) conducted all the conversations using layperson vocabulary, based on their respective training and experience. For both surgeons, this included the following items. First, the planned procedure and its purpose were described, including the expected length, anesthesia requirements, and details of postoperative care and ongoing topical therapy. The nature of major uncommon complications (orbital injury and cerebrospinal fluid leak) and minor complications (bleeding, nasal packing, pain, headache, need for revision) were then explained to the patient. Finally, any outstanding patient questions were addressed. The patient was then approached to participate in this study. All surgical candidates, regardless of whether or not they decided to proceed with ESS, were recruited. All survey data was collected anonymously along with demographic information.
Outcome measure
Patients and methods Study design The study design consisted of a prospective observational study.
Study population Patients were recruited from the rhinology clinics of 2 tertiary care referral centers: St. Joseph’s Health Care (London, ON, Canada) and The Ottawa Hospital (Ottawa, ON, Canada). Consecutive patients diagnosed with medically resistant CRS (with or without nasal polyps) as per the 2011 Canadian Rhinosinusitis Guidelines were recruited into this study.5 English-speaking patients age >18 years were included. Patients who had previously undergone ESS were excluded. This study received ethics approval from the Ottawa Hospital Research Institute (REB #2011680) and Western University Health Sciences Research Ethics Board (Review #13772E).
Survey All patients completed a previously validated questionnaire: the Western Surgical Concern Inventory–Endoscopic Sinus Surgery (WSCI) questionnaire.6 The WSCI questionnaire surveys patients regarding 4 areas of potential areas of concern: general surgical, ESS-specific, psychosocial, and wait time concerns. The questionnaire consists of 19 questions in total (6, 7, 5, and 1 questions in each of the 4 categories, respectively). Patients are asked to rate their degree of concern on a 9-point Likert scale with descriptors for odd-numbered scores: 9 on this scale corresponded to “major concerns”; 7 to “many concerns”; 5 to “moderate concerns”; 3 to “very few concerns”; and 1 to “no concerns.”
Survey administration Patients were approached regarding study participation after the risks and benefits of ESS were discussed. Two staff
659
International Forum of Allergy & Rhinology, Vol. 4, No. 8, August 2014
The primary outcome measure consisted of the WSCI questionnaire data.
Statistical analysis Descriptive statistics were employed for our analysis of scaled responses to the questions posed in the questionnaire. For comparison, the questions were subdivided into their 4 respective categories for analysis (general, ESS-specific, psychosocial, and wait time). Mean scores were used for each category. Data were also stratified in a binary fashion for analysis; scores between 5 (moderate concern) to 9 (major concerns) were considered to be a significant level of concern. Comparisons between various subgroups were made using an analysis of variance.
Results A total of 180 patients completed the WSCI questionnaire; 103 respondents were from the Ottawa site and 77 were from the London site. The mean ± standard deviation (SD) age of participants was 52.3 ± 14.9 years. Forty-two percent (42%) of participants (76 individuals) were female. The response rate for questions was 97.7% to 100% (177180 responses per question). Unanswered questions were not included in the analysis. On average, participants exhibited very few concerns regarding all aspects of surgery, with a mean overall scaled score of 2.8. The response range for the majority of questions used the entire scale from 1 to 9. The proportion of respondents who reported a mean concern of 5 or greater was 21%. The mean proportion of respondents in each of the 4 subcategories with average concern score of 5 or greater were as follows: general surgical, 25%; ESS-specific, 27%; psychosocial, 6%; and wait time, 32%. The areas found to be most concerning to the participants were as follows: (1) primary problem not fixed by surgery, 3.7 ± 2.1; (2) need for revision surgery, 3.4 ± 2; (3) general
Yeung et al.
FIGURE 1. Mean preoperative concerns by institution.
surgical complication, 3.4 ± 1.7; and (4) wait time for surgery, 3.4 ± 2.4. Participants reported the least amount of concern regarding psychosocial issues surrounding surgery. Breakdown of preoperative concern by question and site are described in Figure 1. Summary statistics for all questions are described in Table 1. The mean overall scores for each category were as follows: (1) general surgical concern, 3.0 ± 0.4; (2) ESSspecific concerns, 3.1 ± 0.4; (3) psychosocial concerns, 1.8 ± 0.2; and (4) surgical wait time, 3.4 ± 2.4. Pairwise comparison revealed a statistically significant difference between concerns about surgical complications (both general and ESS-specific) and psychosocial (p < 0.0001) and wait time concerns (p = 0.0054). These differences remained when the data were adjusted for age and gender (Table 2). However, no statistically significant differences in overall concern were observed for either age or gender. The difference between concerns reported by patients in Ottawa vs those in London was found to be statistically significant (p = 0.0205). Patients from London were most concerned about anesthetic risk (2.5 ± 2.6) and need for revision surgery (3.5 ± 2.1). In contrast, patients from Ottawa were most concerned about failure to correct symptoms (4.1 ± 2.1) and surgical wait time (3.9 ± 2.4).
Discussion CRS can be a burdensome disease that significantly impairs one’s perceived quality of life. Patients suffering from CRS were previously found to have similar self-perceived health status as those with asthma, arthritis, cancer, and
TABLE 1. Summary statistics Question
n
Missing (n) Mean SD Minimum Maximum
Surgical complication
179
1
3.4
1.7
1
8
Anesthetic
179
1
3.2
2.3
1
9
Daily activities
179
1
2.6
1.9
1
9
Pain and discomfort
180
0
3.3
1.9
1
9
Resume work
180
0
3.1
2.1
1
9
Burden
179
1
2.4
1.6
1
9
Nasal breathing
180
0
2.8
1.8
1
9
Problem not fixed
178
2
3.7
2.1
1
9
Epistaxis
178
2
3.1
1.9
1
9
Revision surgery
178
2
3.4
2
1
9
Packing
176
4
2.9
2
1
9
Cerebrospinal fluid leak 177
3
3
2.2
1
9
Eye injury
177
3
3.2
2.1
1
9
Embarrassed
176
4
1.9
1.5
1
9
Depressed
178
2
1.7
1.3
1
7
Social activities
179
1
1.9
1.4
1
9
Judged
179
1
1.5
1.1
1
7
Questions answered
179
1
1.9
1.4
1
9
Wait time
179
1
3.4
2.4
1
9
SD = standard deviation.
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Sinus surgery patient preoperative concerns
TABLE 2. Age-adjusted and gender-adjusted pairwise
comparison of the 4 WSCI categoriesa
General surgical ESS-specific Psychosocial
ESS-specific
Psychosocial
Wait time
0.6266
< 0.0001
0.0054
< 0.0001
0.1485 < 0.0001
a Patients demonstrated significantly different degree of concern for psychosocial aspects of surgery vs those related to surgery. Bold values are significant. ESS = endoscopic sinus surgery; WSCI = Western Surgical Concern Inventory– Endoscopic Sinus Surgery.
inflammatory bowel disease.7 CRS, however, is not a lifethreatening disease. Therefore, CRS patients have a fundamentally different set of considerations when deciding on surgery when compared to patients with potentially lifethreatening diseases. Furthermore, ESS is an ideal procedure to study due to its well-defined set of risks and complications. The current study is the first to systematically assess the considerations and concerns in this particular group of patients and provides normative data on patient concerns based on current practices for providing informed consent. Overall, patients appeared to have a low degree of preoperative concern prior to undergoing ESS. Approximately three-quarters of patients rated their concerns at 4 or below for a majority of concerns addressed within the WSCI questionnaire, corresponding to very few concerns. The degree of concern did not vary by gender or by age. Patients expect a comprehensive discussion surrounding all risks of ESS, regardless of severity or rarity.8, 9 The current findings suggest that following such discussion surrounding risks and benefits of ESS, the majority of patients have few concerns about specific aspects and complications of ESS. This indicates that the physician’s capacity to clearly and directly identify and discuss the potential risks of this specific procedure, ESS, may in and of itself serve to substantially reduce anticipatory anxiety prior to surgery. As a result, this level of communication may also facilitate a more open dialogue between the patient and the physician in the postoperative period. Further, it may also lead to reduced postoperative pain, distress, and disability that is associated with patient anxiety.10 In this study, patients exhibited the greatest degree of concern regarding whether or not ESS would relieve their symptoms (problem not fixed and a need for revision surgery (OR)). Based on the present data, we did not identify a single category of risks that patients found particularly concerning. Psychological concerns (such as feeling judged or embarrassed about surgery) appeared to be minimally concerning for patients undergoing ESS. This finding is of importance, as the psychological morbidity in patients suffering from CRS may differ from those of other chronic illnesses, such as inflammatory bowel disease.11 Lending to this finding may be the fact that the surgery is performed
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with endoscopic techniques, thus there are no overt signs of having undergone a sinus surgical treatment, nor any external signs of the disease being present. Interestingly, severe yet rare complications such as orbital injury and cerebrospinal fluid leak were not causes of increased concern. This finding is likely explained by the study methodology, whereby the WSCI Questionnaire was administered following the solicitation of informed consent. This suggests that the incidence of rare but ominous complications does not, in general, deter patients from pursuing ESS for treatment of their CRS. Thus, it would appear that when presented with comprehensive information on potential complications, patients are able to evaluate the risk:benefit of the procedure in an informed manner. Alternatively, it may suggest that patients simply do not comprehend the severity of major complications despite prior discussion with the surgeon. This is in keeping with data from a similar study on diagnostic thyroid surgery where patients were found to be most concerned about their thyroid nodules harboring malignancy, more so than the rare ominous complications of thyroid surgery itself.12 These hypotheses warrant further study. Individual variability in responses was observed in the data as evidenced by the broad range of responses. Nevertheless, only a small proportion of patients reported significant degrees of concern (representing the entire range of the Likert scale). When these patients’ questionnaires were examined, a more pronounced difference in areas of concern between institutions was observed. In this study, 2 staff physicians conducted all conversations regarding informed consent and the data suggest that some degree of information bias does indeed exist. Topics covered during informed consent discussion were, however, largely the same between the 2 surgeons. While these variations may not affect the majority of patients, individual variation in physician-led discussion may affect the perspectives of “high anxiety” patients differently. These findings also indicate that a subset of CRS patients may require additional counseling prior to surgery. Though investigating the determinants of patient concern/anxiety was outside the scope of this study, the present findings would suggest that other factors may influence perceived concerns of, and the responses provided by patients. For example, the time that is required for such information provision may be a key factor relative to easing a patient’s level of anxiety. Past research suggest that providing adequate time for patient-physician communication may result in increased levels of patient satisfaction with the care they receive.13 Therefore, presentation of information must also be followed by an opportunity for the patient to ask questions, for specific information to be discussed in more detail or clarified, or quite frankly, to permit the patient the chance to not feel “rushed” in making their decision or in seeking further information. Additionally, disease-specific factors (ie, nasal polyposis increases the risk of requiring revision surgery) as well as comorbid conditions (ie, cardiac history increases the risk of undergoing general anesthetic) may influence preoperative
Yeung et al.
concerns of individual patients and warrants further investigation. Patients’ relatively strong concerns regarding the wait time for their sinus surgery is of relevance. It speaks to the status of surgical wait times in a publicly funded healthcare system (Ontario, Canada). While ESS is not a lifesaving surgery, patients do indeed suffer increased morbidity through a lack of disease control as a result of wait times for surgical therapy. Naturally, their concerns regarding accessibility to care is reflected in the data and even exceed perceived concerns relative to the potentially severe complications of ESS. These patients are also likely sensitized to the issue of waiting months for surgery given the wait times they have incurred leading up to the intervention. In Canada, referral to an otolaryngologist is associated with a significant wait time, notwithstanding the time to diagnosis of CRS and time required to undergo a computed tomography (CT) scan of the paranasal sinuses prior to surgery. Exploring differences in expectations and concerns of patients who have access to a privately funded healthcare system would be of interest. In the present study design, the WSCI questionnaire was purposefully administered following the informed consent conversation between patient and physician. This ensured the accuracy and completeness of information available to the patient prior to inquiring about their concerns. However, this methodology also potentially left patient re-
sponses susceptible to information bias due to stylistic variations by which each surgeon presented information. Furthermore, patient concern may vary significantly based on how the information is presented. Certainly, these limitations may explain the unexpectedly low degree of concerns identified by this study. Additionally, this study does not address the retention of information following physicianpatient encounters.
Conclusion This is the first study to systematically characterize the preoperative concerns of patients undergoing ESS in a large sample. The results demonstrate that following the informed consent process, the majority of patients do not exhibit major concerns prior to undergoing ESS. Further, our data suggest a discrepancy between physician concerns, which typically involve severe complications, and those of the patient. This study provides normative data and will permit future investigation into factors that increase or decrease preoperative concern as well as the determination of variations in patient concern over time. Additionally, further exploration of issues related to optimizing the time requirement of information provision and its potential impact on patient perception is warranted. Collectively, such information will aid in tailoring conversations surrounding informed consent and providing individualized care.
References 1.
2.
3.
4.
5.
Soler ZM, Wittenberg E, Schlosser RJ, Mace JC, Smith TL. Health state utility values in patients undergoing endoscopic sinus surgery. Laryngoscope. 2011;121:2672–2678. Schiller JS, Lucas JW, Ward BW, Peregoy JA. Summary health statistics for U.S. adults: National Health Interview Survey, 2010. Vital Health Stat 10. 2012;(252):1–207. Charles C, Gafni A, Whelan T. Decision-making in the physician-patient encounter: revisiting the shared treatment decision-making model. Soc Sci Med. 1999;49:651–661. Stewart MA. Effective physician-patient communication and health outcomes: a review. CMAJ. 1995;152:1423–1433. Desrosiers M, Evans GA, Keith PK, et al. Canadian clinical practice guidelines for acute and chronic
6.
7.
8.
9.
rhinosinusitis. Allergy Asthma Clin Immunol. 2011; 7:2. Brandt MG, Rotenberg BW, Yeung JC, Franklin JH, Doyle PC. Prospective evaluation of preoperative concern among patients considering endoscopic sinus surgery: initial validation. Int Forum Allergy Rhinol. 2011;1:219–224. Macdonald KI, McNally JD, Massoud E. The health and resource utilization of Canadians with chronic rhinosinusitis. Laryngoscope. 2009;119:184–189. Bowden MT, Church CA, Chiu AG, Vaughan WC. Informed consent in functional endoscopic sinus surgery: the patient’s perspective. Otolaryngol Head Neck Surg. 2004;131:126–132. Wolf JS, Chiu AG, Palmer JN, et al. Informed consent in endoscopic sinus surgery: the patient perspective. Laryngoscope. 2005;115:492–494.
10. Crockett JK, Gumley A, Longmate A. The development and validation of the Pre-operative Intrusive Thoughts Inventory (PITI). Anaesthesia. 2007;62:683–689. 11. Rochelle TL, Fidler H. The importance of illness perceptions, quality of life and psychological status in patients with ulcerative colitis and Crohn’s disease. J Health Psychol. 2013;18:972– 983. 12. Brandt MG, Franklin JH, Osborn HA, et al. The Western Surgical Concern Inventory-Thyroid: development and initial validation. Otolaryngol Head Neck Surg. 2012;147:227–232. 13. Lin CT, Albertson GA, Schilling LM, et al. Is patients’ perception of time spent with the physician a determinant of ambulatory patient satisfaction? Arch Intern Med. 2001;161:1437–1442.
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