- Email: [email protected]
Ureteroscopy versus Shock Wave Lithotripsy: Factors Influencing Patient Treatment Preferences
Business of Urology urologypracticejournal.com
Ureteroscopy versus Shock Wave Lithotripsy: Factors Influencing Patient Treatment Preferences Robert Steven Gerhard,* Adam Shrewsberry, Tania Solomon, Dana Nickleach, Yuan Liu, John Pattaras and Kenneth Ogan From the Department of Urology, Emory University School of Medicine, Atlanta, Georgia
Abstract Introduction: Shock wave lithotripsy and ureteroscopy are considered first line treatment options for patients with urolithiasis. However, these interventions have significant variation in rates of stone-free success, procedure related complications and need for reoperation. We examined patient preferences in treatment selection for urolithiasis and factors associated with choice of treatment.
Abbreviations and Acronyms SWL = shock wave lithotripsy URS = ureteroscopy
Methods: Patients with a history of urolithiasis were self-administered or mailed a questionnaire with a clinical scenario of a stone in the ureter and outcome statistics derived from a Cochrane Review for ureteroscopy and shock wave lithotripsy comparing stone-free success rates, complication rates, need for ureteral stent placement and need for additional surgery. Subjects were asked to choose ureteroscopy or shock wave lithotripsy and to indicate the relative importance that each of the 4 outcome parameters had on their treatment selection. Results: A total of 163 patients returned complete surveys and a majority preferred ureteroscopy to shock wave lithotripsy (63% vs 37%, p¼0.001) for the clinical scenario presented. For factors influencing procedure preference success was indicated as extremely important by 94% (152 of 163) of respondents, followed by complications, need for second surgery and, finally, need for stent. Conclusions: A majority of patients preferred ureteroscopy to shock wave lithotripsy after reviewing the evidence-based rates of stone-free success, complications and need for second surgery. Shared decision making and patient centered care should be the focus of surgical treatment selection when there is no consensus regarding a superior treatment for urolithiasis. Key Words: urolithiasis, lithotripsy, ureteroscopy, patient preference
Submitted for publication July 31, 2015. No direct or indirect commercial incentive associated with publishing this article. The corresponding author certifies that, when applicable, a statement(s) has been included in the manuscript documenting institutional review board, ethics committee or ethical review board study approval; principles of Helsinki Declaration were followed in lieu of formal ethics committee approval; 2352-0779/16/36-423/0 UROLOGY PRACTICE Ó 2016 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
AND
institutional animal care and use committee approval; all human subjects provided written informed consent with guarantees of confidentiality; IRB approved protocol number; animal approved project number. * Correspondence: Department of Urology, The Emory Clinic, 1365 Clifton Rd., Atlanta, Georgia 30322 (telephone: 404-778-3038; e-mail address: [email protected]).
RESEARCH, INC.
http://dx.doi.org/10.1016/j.urpr.2015.11.001 Vol. 3, 423-429, November 2016 Published by Elsevier
424
Patient Preference for Ureteroscopy versus Shock Wave Lithotripsy
Overall 1 in 11 Americans will be diagnosed with urolithiasis in their lifetime.1 For stones that require intervention several treatment modalities are available to the patient and urologist, including extracorporeal shock wave lithotripsy, endourologic surgery including ureteroscopy or percutaneous nephrolithotomy and, rarely, open surgery. For a majority of calculi smaller than 2 cm that require removal URS and SWL are considered first line management by the American Urological Association (for ureteral calculi)2 and European Association of Urology.3 Although URS and SWL are comparable management options, they are associated with different risks and benefits. A 2012 Cochrane Review of randomized controlled trials comparing SWL with ureteroscopic management for ureteral calculi reported that URS was associated with a greater stone-free rate, lower rates of re-treatment and higher rates of procedure related complications.4 In the absence of evidence to demonstrate the superiority of SWL or URS the decision on treatment modality is left to the provider and patient. Factors influencing treatment selection (URS vs SWL) have been previously examined and several nonclinical factors have been identified. For example, a survey of practicing urologists showed that the odds of a patient undergoing SWL was 3 to 4 times higher if the provider had ownership of a shock wave lithotripter.5 Furthermore, the use of SWL is associated with increased time since training and a community practice setting.5,6 Few studies have examined patient preference and/or satisfaction regarding treatment selection. A prospective study of patients with ureteral calculi managed with SWL or URS reported that patient satisfaction was significantly higher among those treated with URS compared to SWL (94% vs 80%, p¼0.002).7 Patient centered care and shared decision making are fundamental tenets in improving the quality of health care in the United States.8 For conditions with multiple comparable treatment options there should be a discussion between patient and clinician regarding the specific risks and relevant outcomes for each treatment modality. The available literature regarding URS and SWL has focused primarily on comparable efficacy, and clinical and provider factors associated with treatment selection. However, an opportunity exists to examine patient preference in treatment selection for urolithiasis. The purpose of this study was to provide patients with evidence-based outcomes and education regarding URS vs SWL for the management of urolithiasis and to determine which treatment modality they would prefer. We hypothesized that patients would elect URS (vs SWL) after reviewing relevant outcomes such as rate of success, complications and reoperation.
Materials and Methods
Before initiation of this study it was reviewed and approved by an institutional review board. All patients with a diagnosis of urolithiasis (ICD-9 code 592 and 592.1) at our institution from 2007 to 2012 were identified and mailed a self-administered questionnaire (see Appendix). The survey was mailed to 750 randomly selected patients seen at our clinic from 2008 to 2012 with a principal diagnosis code for urolithiasis. Overall 97 patients (12.9%) returned surveys and of these patients 94 were included in the analytic cohort as 3 returned incomplete surveys. Surveys were also distributed at our clinic to first-time patients with a chief complaint of urolithiasis between August and October 2012. Data were not collected regarding the number who refused to participate in the study. A total of 71 surveys were obtained from the clinic, of which 2 were incomplete and, thus, not included in the analytic cohort. The questionnaire included basic demographic and kidney stone history items. An educational section regarding URS and SWL for urolithiasis was included which provided definitions of ureteroscopy, shock wave lithotripsy, success, complications and ureteral stent. A table comparing the rates of success, complications, need for stent at time of surgery and need for second surgery was provided (see Appendix). Outcomes statistics were derived from a Cochrane Review of randomized controlled trials comparing SWL and URS for ureteral calculi.4 The survey posed the clinical scenario, “You are diagnosed with a stone in your ureter (the tube that drains the kidney). You are provided the treatment options of ureteroscopy or shock wave lithotripsy.” After reviewing the evidence-based outcomes, patients were asked which procedure they would choose for the clinical scenario. For each outcome factor presented (rate of stone-free success, complications, need for second surgery, need for ureteral stent), patients were asked to indicate how these factors influenced their treatment decision using a 1 to 5 Likert scale. Statistical analysis was conducted using SASÒ version 9.3. Descriptive statistics for each variable were reported. Chi-square analysis was used to test for differences in procedure preference. The unadjusted association of each variable with each decision making factor and the outcome was assessed using the chi-square test or Fisher’s exact test for categorical covariates where appropriate, and analysis of variance for numerical covariates. A multivariable logistic regression model was fit. Decision making factors were forced in the model, and the variables age, gender, body mass index, race, income, education, employment, marital status, family history of stones, first time with stones, age at first stone, time since last stone, previous SWL/URS, previous percutaneous
425
Patient Preference for Ureteroscopy versus Shock Wave Lithotripsy
nephrolithotomy, previous open surgery, previous stent, number of emergency room visits, number of missed work days, type of dietary change for stone prevention, and on medications for stone prevention were entered into the model subject to a backward variable selection method with an alpha¼0.20 removal criteria. The number of stone surgeries and previous complications were not included in order to avoid multicollinearity issues with the previous type of surgery variables. The lifetime number of stones was also excluded from analysis due to multicollinearity.
Results
A total of 163 patients returned completed surveys. Approximately 40% of the respondents were acquired via clinic recruitment while the remainder returned mailed surveys. Of the patients identified as having a diagnosis of urolithiasis who were mailed surveys 13.1% responded. The supplementary table (http://urologypracticejournal.com/) contains baseline demographics and stone history. Consistent with gender specific incidences of stone disease 41% of respondents were female and 59% were male. About 80% (129 of 163) had at least 1 prior stone procedure. Among the cohort 27% (44 of 163) had been treated with URS and SWL previously, 22% (35 of 163) had been treated with URS but not SWL and 23% (37 of 163) SWL but not URS. Prior stone surgery was evenly distributed in the cohort. A significant majority preferred URS to SWL (63% vs 37%, p¼0.001) for the clinical scenario presented. For factors influencing procedure preference, success was indicated as extremely important by 94% (152 of 163) of respondents, followed by complications, need for second surgery and, finally, need for stent (table 1). Univariate analysis of decision making factors and procedure preference is presented in table 2. The 102 patients who chose URS valued success and need for second surgery more than the 61 who chose SWL, while those patients who chose SWL valued complication rate and need for a stent more than those who chose URS. On univariate analysis only race and procedure history were significantly associated with procedure preference (table 3). Those patients with a history of URS overwhelmingly favored URS (80% vs 20%, p¼0.001). Patients with a history of URS and SWL also favored URS (66% vs 34%, p¼0.035). In patients with a history of SWL there was no association with treatment decision, although the trend favored SWL (43% vs 57%, p¼0.41). Finally, in patients without a history of URS or SWL there was no association with treatment decision, although the trend favored URS (62% vs 38%, p¼0.11). On multivariate analysis after
Table 1. Procedure preference and importance of factors associated with decision Level
No. (%)
URS SWL Large/extremely Large/extremely Large/extremely Large/extremely
102 61 152 126 110 75
Procedure preference:
Success Complications Need for 2nd surgery Need for stent
(62.6) (37.4) (93.8) (79.7) (69.2) (47.5)
backward variable selection 3 patient specific variables were included in the final model to predict treatment preference (URS vs SWL), including body mass index, previous stent placement and previous URS/SWL. In the adjusted model there was no significant association between prior URS/ SWL and treatment preference.
Discussion
URS and SWL are considered first line management for a majority of patients with urolithiasis.2,3 However, these interventions have significant variation in success, complication rates and need for reoperation.4 Previous studies have identified several nonclinical provider factors associated with treatment selection such as time since training, community practice setting and ownership of a shock wave lithotripter.5,6 For a patient evaluated by a urologist with ownership of a shock wave lithotripter the odds of undergoing SWL as opposed to URS may be 3 to 4 times greater.5 These findings suggest that there may be opportunities for improved shared decision making and patient centered care. In this study we examined patient preference for URS vs SWL in the management of urolithiasis after patients had the opportunity to review relevant evidence-based outcomes and descriptions of each procedure. We hypothesized that patients would elect URS (vs SWL) after reviewing relevant outcomes such as rate of success, complication and reoperation. In our cohort nearly 2 of 3 patients indicated that they would prefer URS compared to SWL after reviewing the evidence-based outcomes data (63% vs 37%, p¼0.001). Stone-free success and decreased need for second operation were cited as important factors in deciding on their treatment preference. These findings emphasize the importance of appropriately counseling patients before arriving at treatment selection. Patients with urolithiasis should be informed of the specific rates of success, reoperation and complications for URS and SWL before making their preferred treatment decision. More than 90% of our cohort indicated that knowing
426
Patient Preference for Ureteroscopy versus Shock Wave Lithotripsy
Table 2. Univariate association of decision making factors and procedure preference Covariate
Importance Level
No. URS Preference (%)
No. SWL Preference (%)
Large/extremely Not at all/small/moderate
101 (99.02) 1 (0.98)
51 9
(85) (15)
Large/extremely Not at all/small/moderate
72 (73.47) 26 (26.53)
54 6
(90) (10)
Large/extremely Not at all/small/moderate
76 (76.77) 23 (23.23)
34 (56.67) 26 (43.33)
Large/extremely Not at all/small/moderate
36 (36.73) 62 (63.27)
39 21
Success:
p Value* <0.001 0.012
Complications:
0.008
Need for 2nd surgery:
Need for stent: (65) (35)
<0.001
*Calculated by the chi-square test or Fisher’s exact test where appropriate.
the stone-free rate/success of each treatment was extremely important in their treatment selection. Research has shown that a perception-reality gap exists in the use of shared decision making and that treatment selection is too often influenced by clinician preferences.9 In other fields of medicine significant regional variation in practice patterns exists for joint replacement surgery, and surgery for lower back pain and early stage breast cancer, suggesting that the treatment received by patients may have less to do with their preference and may be more closely aligned with clinicians’ payment incentives.10 For urolithiasis this is evidenced by the use of SWL among clinicians with ownership of shock wave lithotripters.5 Comparative effectiveness research and randomized controlled studies comparing SWL and URS for urolithiasis remain areas of need. In the absence of superiority the focus should be on patient preference and economic costs instead of provider preference. A prospective trial of patients with urolithiasis managed with URS or SWL reported that satisfaction was superior among those treated with URS.7 Similarly, our study demonstrates that of patients with prior stone related surgery, those who had undergone URS or URS and SWL preferentially chose URS in the clinical scenario.
While not addressed in our study, the economic impact of stone disease treatment choice must also be considered. The Urological Diseases in America project estimated an annual cost of greater than $2 billion in the United States for the medical evaluation and treatment of kidney stones. In a recent systematic review of the literature Matlaga et al demonstrated that URS had a lower cost compared to SWL.11 With the implementation of the Affordable Care Act, costeffectiveness outcomes of competitive treatments will be under significant investigation. We did not specifically ask our study participants if cost impacted their treatment decision, but we would infer that in a third party payer system it would not have major importance. However, as out of pocket costs for patients are increasing with the Affordable Care Act, cost may have a larger impact on patient decision making and this is something that should be explored in the future. There are several limitations to our study that are worth mentioning. As with any questionnaire based study there was a low response rate among patients mailed studies despite followup telephone calls, which introduces response bias. In addition, patients were recruited from an academic urology practice in which many patients may have more severe stone disease. As such, the results may not be applicable to patients presenting to a nonacademic practice.
Table 3. Univariate association of demographics and stone history with procedure preference Covariate
Level
No. URS Preference (%)
No. SWL Preference (%)
White Other 1þ
76 (58.46) 26 (81.25) 83 (64.34)
54 (41.54) 6 (18.75) 46 (35.66)
URS þ SWL URS but not SWL SWL but not URS Neither URS nor SWL
29 (65.91) 28 (80) 16 (43.24) 29 (61.7)
15 (34.09) 7 (20) 21 (56.76) 18 (38.3)
p Value* 0.017
Race:
0.014
Previous URS/SWL:
*Calculated by the chi-square test or Fisher’s exact test where appropriate.
Patient Preference for Ureteroscopy versus Shock Wave Lithotripsy
Conclusions
Nearly 2 of 3 patients with a history of urolithiasis preferred URS over SWL after reviewing the evidence-based rates of stone-free success, complications and need for second
surgery. Shared decision making and patient centered care should be the focus of surgical treatment selection when there is no consensus regarding a superior treatment for urolithiasis.
Appendix.
Emory University Department of Urology Kidney Stone Questionnaire Please Answer the Following Questions: DEMOGRAPHICS
Name: ___________________________ Age: ______ Sex: Male / Female Weight: __________
Height: __________
Race: Caucasian / African American / Hispanic / Asian / Other Highest level of education completed: ______________ Are you married? Y or N Annual household Income: _____________ Employment status: Full-time / Part-time / Retired / Unemployed
KIDNEY STONE HISTORY
Do you have a family history of kidney stones? Y or N Is this your first time with kidney stones? Y or N How many kidney stones have you had in your life? _________ How old were you when you had your first kidney stone? ________ When was the last time you had a kidney stone attack or surgery? _________ How many surgeries have you had for kidney stones? _________ Shock wave lithotripsy __________ Ureteroscopy (basket or laser) _________ PCNL (incision in back) _________ Open surgery _________ Stent placement _________ Did you have any complications from surgery? Y or N How many times have you been to the ER for kidney stones? _________ How many days of work have you missed in the last year secondary to stones? __________ Do you make dietary changes for stone prevention? Y or N Strict diet
427
/ Moderate diet / No diet
Are you currently on medications for stone prevention? Y or N Thiazide / Potassium citrate / Allopurinol / Other __________
428
Patient Preference for Ureteroscopy versus Shock Wave Lithotripsy
Below are definitions followed by a clinical scenario that patients often find themselves. Please read the scenario and answer the questions that follow. Your participation will help guide the treatment of future patients that suffer from stone disease.
Definitions • Ureteroscopy: Patients are put to sleep with a general anesthetic, a small telescope is placed into the bladder and ureter (the tube that drains the kidney), and the stone is either grasped/removed or a laser is used to break up the stone. No incisions are made on the outside of the body. Patients are typically discharged home the same day of the procedure. Postoperatively at home, pain medications are needed approximately 90% of the time for an average of 3-4 days. Average recovery is 5-6 days. • Shock Wave Lithotripsy: Patients are either sedated or put to sleep with a general anesthetic, and sound waves are used to break up the stone from outside the body. No instruments are placed inside and no incisions are made on the outside of the body. Patients are typically discharged home the same day of the procedure. Postoperatively at home, pain medications are needed approximately 60% of the time for an average of 3-4 days. Average recovery is 5-6 days. • Success: Chance that you are stone-free from the procedure. • Complications: Infection, fever, bleeding requiring transfusion, injury to the ureter, ureteral stricture, and blockage of the ureter. • Stent: A stent is a thin plastic tube that is inserted into the ureter during surgery to drain the kidney and help small stone fragments pass. Stents stay in place from a few days to several weeks. The stent is either removed at home by the patient or in the office by the urologist with a small telescope.
Scenario: You are diagnosed with a stone in your ureter (the tube that drains the kidney). You are provided the treatment options of ureteroscopy or shock wave lithotripsy. The below table compares the two procedures:
TREATMENT
Ureteroscopy Shock Wave Lithotripsy
SUCCESS (stone-free)
COMPLICATIONS
NEED FOR STENT AT TIME OF SURGERY
92% 77%
16% 9%
39% 16%
NEED FOR 2 SURGERY
3% 21%
1. Which procedure would you choose? (please CIRCLE ONE)
a. Ureteroscopy
b. Shock wave lithotripsy
2. In this scenario, please CIRCLE how important EACH factor was in making your decision. (Rank: 5 is extremely important and 1 is not important) Not important at all
Factor
Small amount of importance
Moderate importance
Large importance
Extremely important, would not compromise
Success
1
2
3
4
5
Complications
1
2
3
4
5
Need for stent
1
2
3
4
5
1
2
3
4
5
1
2
3
4
5
Need for 2 surgery
nd
Other ______________
ND
Patient Preference for Ureteroscopy versus Shock Wave Lithotripsy
References 1. Scales CD, Smith AC, Hanley JM et al: Prevalence of kidney stones in the United States. Eur Urol 2012; 62: 160. 2. Preminger GM, Tiselius HG, Assimos DG et al: 2007 Guideline for the management of ureteral calculi. Eur Urol 2007; 52: 1610. 3. Türk C, Knoll T, Petrik A et al: Guidelines on Urolithiasis. Arnhem, The Netherlands: European Association of Urology 2011. 4. Aboumarzouk OM, Kata SG, Keeley FX et al: Extracorporeal shock wave lithotripsy (ESWL) versus ureteroscopic management for ureteric calculi. Cochrane Database Syst Rev 2012; 5: CD006029. 5. Childs MA, Rangel LJ, Lingeman JE et al: Factors influencing urologist treatment preference in surgical management of stone disease. Urology 2012; 79: 996.
429
6. Scales CD, Krupski TL, Curtis LH et al: Practice variation in the surgical management of urinary lithiasis. J Urol 2011; 186: 146. 7. Ghalayini IF, Al-Ghazo MA and Khader YS: Extracorporeal shockwave lithotripsy versus ureteroscopy for distal ureteric calculi: efficacy and patient satisfaction. Int Braz J Urol 2006; 32: 656. 8. Barry MJ and Edgman-Levitan S: Shared decision makingepinnacle of patient-centered care. N Engl J Med 2012; 366: 780. 9. Stiggelbout AM, Van der Weijden T, De Wit MP et al: Shared decision making: really putting patients at the centre of healthcare. BMJ 2012; 344: e256. 10. Oshima Lee E and Emanuel EJ: Shared decision making to improve care and reduce costs. N Engl J Med 2013; 368: 6. 11. Matlaga BR, Jansen JP, Meckley LM et al: Economic outcomes of treatment for ureteral and renal stones: a systematic literature review. J Urol 2012; 188: 449.
Ureteroscopy versus Shock Wave Lithotripsy: Factors Influencing Patient Treatment Preferences Robert Steven Gerhard,* Adam Shrewsberry, Tania Solomon, Dana Nickleach, Yuan Liu, John Pattaras and Kenneth Ogan From the Department of Urology, Emory University School of Medicine, Atlanta, Georgia
Abstract Introduction: Shock wave lithotripsy and ureteroscopy are considered first line treatment options for patients with urolithiasis. However, these interventions have significant variation in rates of stone-free success, procedure related complications and need for reoperation. We examined patient preferences in treatment selection for urolithiasis and factors associated with choice of treatment.
Abbreviations and Acronyms SWL = shock wave lithotripsy URS = ureteroscopy
Methods: Patients with a history of urolithiasis were self-administered or mailed a questionnaire with a clinical scenario of a stone in the ureter and outcome statistics derived from a Cochrane Review for ureteroscopy and shock wave lithotripsy comparing stone-free success rates, complication rates, need for ureteral stent placement and need for additional surgery. Subjects were asked to choose ureteroscopy or shock wave lithotripsy and to indicate the relative importance that each of the 4 outcome parameters had on their treatment selection. Results: A total of 163 patients returned complete surveys and a majority preferred ureteroscopy to shock wave lithotripsy (63% vs 37%, p¼0.001) for the clinical scenario presented. For factors influencing procedure preference success was indicated as extremely important by 94% (152 of 163) of respondents, followed by complications, need for second surgery and, finally, need for stent. Conclusions: A majority of patients preferred ureteroscopy to shock wave lithotripsy after reviewing the evidence-based rates of stone-free success, complications and need for second surgery. Shared decision making and patient centered care should be the focus of surgical treatment selection when there is no consensus regarding a superior treatment for urolithiasis. Key Words: urolithiasis, lithotripsy, ureteroscopy, patient preference
Submitted for publication July 31, 2015. No direct or indirect commercial incentive associated with publishing this article. The corresponding author certifies that, when applicable, a statement(s) has been included in the manuscript documenting institutional review board, ethics committee or ethical review board study approval; principles of Helsinki Declaration were followed in lieu of formal ethics committee approval; 2352-0779/16/36-423/0 UROLOGY PRACTICE Ó 2016 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
AND
institutional animal care and use committee approval; all human subjects provided written informed consent with guarantees of confidentiality; IRB approved protocol number; animal approved project number. * Correspondence: Department of Urology, The Emory Clinic, 1365 Clifton Rd., Atlanta, Georgia 30322 (telephone: 404-778-3038; e-mail address: [email protected]).
RESEARCH, INC.
http://dx.doi.org/10.1016/j.urpr.2015.11.001 Vol. 3, 423-429, November 2016 Published by Elsevier
424
Patient Preference for Ureteroscopy versus Shock Wave Lithotripsy
Overall 1 in 11 Americans will be diagnosed with urolithiasis in their lifetime.1 For stones that require intervention several treatment modalities are available to the patient and urologist, including extracorporeal shock wave lithotripsy, endourologic surgery including ureteroscopy or percutaneous nephrolithotomy and, rarely, open surgery. For a majority of calculi smaller than 2 cm that require removal URS and SWL are considered first line management by the American Urological Association (for ureteral calculi)2 and European Association of Urology.3 Although URS and SWL are comparable management options, they are associated with different risks and benefits. A 2012 Cochrane Review of randomized controlled trials comparing SWL with ureteroscopic management for ureteral calculi reported that URS was associated with a greater stone-free rate, lower rates of re-treatment and higher rates of procedure related complications.4 In the absence of evidence to demonstrate the superiority of SWL or URS the decision on treatment modality is left to the provider and patient. Factors influencing treatment selection (URS vs SWL) have been previously examined and several nonclinical factors have been identified. For example, a survey of practicing urologists showed that the odds of a patient undergoing SWL was 3 to 4 times higher if the provider had ownership of a shock wave lithotripter.5 Furthermore, the use of SWL is associated with increased time since training and a community practice setting.5,6 Few studies have examined patient preference and/or satisfaction regarding treatment selection. A prospective study of patients with ureteral calculi managed with SWL or URS reported that patient satisfaction was significantly higher among those treated with URS compared to SWL (94% vs 80%, p¼0.002).7 Patient centered care and shared decision making are fundamental tenets in improving the quality of health care in the United States.8 For conditions with multiple comparable treatment options there should be a discussion between patient and clinician regarding the specific risks and relevant outcomes for each treatment modality. The available literature regarding URS and SWL has focused primarily on comparable efficacy, and clinical and provider factors associated with treatment selection. However, an opportunity exists to examine patient preference in treatment selection for urolithiasis. The purpose of this study was to provide patients with evidence-based outcomes and education regarding URS vs SWL for the management of urolithiasis and to determine which treatment modality they would prefer. We hypothesized that patients would elect URS (vs SWL) after reviewing relevant outcomes such as rate of success, complications and reoperation.
Materials and Methods
Before initiation of this study it was reviewed and approved by an institutional review board. All patients with a diagnosis of urolithiasis (ICD-9 code 592 and 592.1) at our institution from 2007 to 2012 were identified and mailed a self-administered questionnaire (see Appendix). The survey was mailed to 750 randomly selected patients seen at our clinic from 2008 to 2012 with a principal diagnosis code for urolithiasis. Overall 97 patients (12.9%) returned surveys and of these patients 94 were included in the analytic cohort as 3 returned incomplete surveys. Surveys were also distributed at our clinic to first-time patients with a chief complaint of urolithiasis between August and October 2012. Data were not collected regarding the number who refused to participate in the study. A total of 71 surveys were obtained from the clinic, of which 2 were incomplete and, thus, not included in the analytic cohort. The questionnaire included basic demographic and kidney stone history items. An educational section regarding URS and SWL for urolithiasis was included which provided definitions of ureteroscopy, shock wave lithotripsy, success, complications and ureteral stent. A table comparing the rates of success, complications, need for stent at time of surgery and need for second surgery was provided (see Appendix). Outcomes statistics were derived from a Cochrane Review of randomized controlled trials comparing SWL and URS for ureteral calculi.4 The survey posed the clinical scenario, “You are diagnosed with a stone in your ureter (the tube that drains the kidney). You are provided the treatment options of ureteroscopy or shock wave lithotripsy.” After reviewing the evidence-based outcomes, patients were asked which procedure they would choose for the clinical scenario. For each outcome factor presented (rate of stone-free success, complications, need for second surgery, need for ureteral stent), patients were asked to indicate how these factors influenced their treatment decision using a 1 to 5 Likert scale. Statistical analysis was conducted using SASÒ version 9.3. Descriptive statistics for each variable were reported. Chi-square analysis was used to test for differences in procedure preference. The unadjusted association of each variable with each decision making factor and the outcome was assessed using the chi-square test or Fisher’s exact test for categorical covariates where appropriate, and analysis of variance for numerical covariates. A multivariable logistic regression model was fit. Decision making factors were forced in the model, and the variables age, gender, body mass index, race, income, education, employment, marital status, family history of stones, first time with stones, age at first stone, time since last stone, previous SWL/URS, previous percutaneous
425
Patient Preference for Ureteroscopy versus Shock Wave Lithotripsy
nephrolithotomy, previous open surgery, previous stent, number of emergency room visits, number of missed work days, type of dietary change for stone prevention, and on medications for stone prevention were entered into the model subject to a backward variable selection method with an alpha¼0.20 removal criteria. The number of stone surgeries and previous complications were not included in order to avoid multicollinearity issues with the previous type of surgery variables. The lifetime number of stones was also excluded from analysis due to multicollinearity.
Results
A total of 163 patients returned completed surveys. Approximately 40% of the respondents were acquired via clinic recruitment while the remainder returned mailed surveys. Of the patients identified as having a diagnosis of urolithiasis who were mailed surveys 13.1% responded. The supplementary table (http://urologypracticejournal.com/) contains baseline demographics and stone history. Consistent with gender specific incidences of stone disease 41% of respondents were female and 59% were male. About 80% (129 of 163) had at least 1 prior stone procedure. Among the cohort 27% (44 of 163) had been treated with URS and SWL previously, 22% (35 of 163) had been treated with URS but not SWL and 23% (37 of 163) SWL but not URS. Prior stone surgery was evenly distributed in the cohort. A significant majority preferred URS to SWL (63% vs 37%, p¼0.001) for the clinical scenario presented. For factors influencing procedure preference, success was indicated as extremely important by 94% (152 of 163) of respondents, followed by complications, need for second surgery and, finally, need for stent (table 1). Univariate analysis of decision making factors and procedure preference is presented in table 2. The 102 patients who chose URS valued success and need for second surgery more than the 61 who chose SWL, while those patients who chose SWL valued complication rate and need for a stent more than those who chose URS. On univariate analysis only race and procedure history were significantly associated with procedure preference (table 3). Those patients with a history of URS overwhelmingly favored URS (80% vs 20%, p¼0.001). Patients with a history of URS and SWL also favored URS (66% vs 34%, p¼0.035). In patients with a history of SWL there was no association with treatment decision, although the trend favored SWL (43% vs 57%, p¼0.41). Finally, in patients without a history of URS or SWL there was no association with treatment decision, although the trend favored URS (62% vs 38%, p¼0.11). On multivariate analysis after
Table 1. Procedure preference and importance of factors associated with decision Level
No. (%)
URS SWL Large/extremely Large/extremely Large/extremely Large/extremely
102 61 152 126 110 75
Procedure preference:
Success Complications Need for 2nd surgery Need for stent
(62.6) (37.4) (93.8) (79.7) (69.2) (47.5)
backward variable selection 3 patient specific variables were included in the final model to predict treatment preference (URS vs SWL), including body mass index, previous stent placement and previous URS/SWL. In the adjusted model there was no significant association between prior URS/ SWL and treatment preference.
Discussion
URS and SWL are considered first line management for a majority of patients with urolithiasis.2,3 However, these interventions have significant variation in success, complication rates and need for reoperation.4 Previous studies have identified several nonclinical provider factors associated with treatment selection such as time since training, community practice setting and ownership of a shock wave lithotripter.5,6 For a patient evaluated by a urologist with ownership of a shock wave lithotripter the odds of undergoing SWL as opposed to URS may be 3 to 4 times greater.5 These findings suggest that there may be opportunities for improved shared decision making and patient centered care. In this study we examined patient preference for URS vs SWL in the management of urolithiasis after patients had the opportunity to review relevant evidence-based outcomes and descriptions of each procedure. We hypothesized that patients would elect URS (vs SWL) after reviewing relevant outcomes such as rate of success, complication and reoperation. In our cohort nearly 2 of 3 patients indicated that they would prefer URS compared to SWL after reviewing the evidence-based outcomes data (63% vs 37%, p¼0.001). Stone-free success and decreased need for second operation were cited as important factors in deciding on their treatment preference. These findings emphasize the importance of appropriately counseling patients before arriving at treatment selection. Patients with urolithiasis should be informed of the specific rates of success, reoperation and complications for URS and SWL before making their preferred treatment decision. More than 90% of our cohort indicated that knowing
426
Patient Preference for Ureteroscopy versus Shock Wave Lithotripsy
Table 2. Univariate association of decision making factors and procedure preference Covariate
Importance Level
No. URS Preference (%)
No. SWL Preference (%)
Large/extremely Not at all/small/moderate
101 (99.02) 1 (0.98)
51 9
(85) (15)
Large/extremely Not at all/small/moderate
72 (73.47) 26 (26.53)
54 6
(90) (10)
Large/extremely Not at all/small/moderate
76 (76.77) 23 (23.23)
34 (56.67) 26 (43.33)
Large/extremely Not at all/small/moderate
36 (36.73) 62 (63.27)
39 21
Success:
p Value* <0.001 0.012
Complications:
0.008
Need for 2nd surgery:
Need for stent: (65) (35)
<0.001
*Calculated by the chi-square test or Fisher’s exact test where appropriate.
the stone-free rate/success of each treatment was extremely important in their treatment selection. Research has shown that a perception-reality gap exists in the use of shared decision making and that treatment selection is too often influenced by clinician preferences.9 In other fields of medicine significant regional variation in practice patterns exists for joint replacement surgery, and surgery for lower back pain and early stage breast cancer, suggesting that the treatment received by patients may have less to do with their preference and may be more closely aligned with clinicians’ payment incentives.10 For urolithiasis this is evidenced by the use of SWL among clinicians with ownership of shock wave lithotripters.5 Comparative effectiveness research and randomized controlled studies comparing SWL and URS for urolithiasis remain areas of need. In the absence of superiority the focus should be on patient preference and economic costs instead of provider preference. A prospective trial of patients with urolithiasis managed with URS or SWL reported that satisfaction was superior among those treated with URS.7 Similarly, our study demonstrates that of patients with prior stone related surgery, those who had undergone URS or URS and SWL preferentially chose URS in the clinical scenario.
While not addressed in our study, the economic impact of stone disease treatment choice must also be considered. The Urological Diseases in America project estimated an annual cost of greater than $2 billion in the United States for the medical evaluation and treatment of kidney stones. In a recent systematic review of the literature Matlaga et al demonstrated that URS had a lower cost compared to SWL.11 With the implementation of the Affordable Care Act, costeffectiveness outcomes of competitive treatments will be under significant investigation. We did not specifically ask our study participants if cost impacted their treatment decision, but we would infer that in a third party payer system it would not have major importance. However, as out of pocket costs for patients are increasing with the Affordable Care Act, cost may have a larger impact on patient decision making and this is something that should be explored in the future. There are several limitations to our study that are worth mentioning. As with any questionnaire based study there was a low response rate among patients mailed studies despite followup telephone calls, which introduces response bias. In addition, patients were recruited from an academic urology practice in which many patients may have more severe stone disease. As such, the results may not be applicable to patients presenting to a nonacademic practice.
Table 3. Univariate association of demographics and stone history with procedure preference Covariate
Level
No. URS Preference (%)
No. SWL Preference (%)
White Other 1þ
76 (58.46) 26 (81.25) 83 (64.34)
54 (41.54) 6 (18.75) 46 (35.66)
URS þ SWL URS but not SWL SWL but not URS Neither URS nor SWL
29 (65.91) 28 (80) 16 (43.24) 29 (61.7)
15 (34.09) 7 (20) 21 (56.76) 18 (38.3)
p Value* 0.017
Race:
0.014
Previous URS/SWL:
*Calculated by the chi-square test or Fisher’s exact test where appropriate.
Patient Preference for Ureteroscopy versus Shock Wave Lithotripsy
Conclusions
Nearly 2 of 3 patients with a history of urolithiasis preferred URS over SWL after reviewing the evidence-based rates of stone-free success, complications and need for second
surgery. Shared decision making and patient centered care should be the focus of surgical treatment selection when there is no consensus regarding a superior treatment for urolithiasis.
Appendix.
Emory University Department of Urology Kidney Stone Questionnaire Please Answer the Following Questions: DEMOGRAPHICS
Name: ___________________________ Age: ______ Sex: Male / Female Weight: __________
Height: __________
Race: Caucasian / African American / Hispanic / Asian / Other Highest level of education completed: ______________ Are you married? Y or N Annual household Income: _____________ Employment status: Full-time / Part-time / Retired / Unemployed
KIDNEY STONE HISTORY
Do you have a family history of kidney stones? Y or N Is this your first time with kidney stones? Y or N How many kidney stones have you had in your life? _________ How old were you when you had your first kidney stone? ________ When was the last time you had a kidney stone attack or surgery? _________ How many surgeries have you had for kidney stones? _________ Shock wave lithotripsy __________ Ureteroscopy (basket or laser) _________ PCNL (incision in back) _________ Open surgery _________ Stent placement _________ Did you have any complications from surgery? Y or N How many times have you been to the ER for kidney stones? _________ How many days of work have you missed in the last year secondary to stones? __________ Do you make dietary changes for stone prevention? Y or N Strict diet
427
/ Moderate diet / No diet
Are you currently on medications for stone prevention? Y or N Thiazide / Potassium citrate / Allopurinol / Other __________
428
Patient Preference for Ureteroscopy versus Shock Wave Lithotripsy
Below are definitions followed by a clinical scenario that patients often find themselves. Please read the scenario and answer the questions that follow. Your participation will help guide the treatment of future patients that suffer from stone disease.
Definitions • Ureteroscopy: Patients are put to sleep with a general anesthetic, a small telescope is placed into the bladder and ureter (the tube that drains the kidney), and the stone is either grasped/removed or a laser is used to break up the stone. No incisions are made on the outside of the body. Patients are typically discharged home the same day of the procedure. Postoperatively at home, pain medications are needed approximately 90% of the time for an average of 3-4 days. Average recovery is 5-6 days. • Shock Wave Lithotripsy: Patients are either sedated or put to sleep with a general anesthetic, and sound waves are used to break up the stone from outside the body. No instruments are placed inside and no incisions are made on the outside of the body. Patients are typically discharged home the same day of the procedure. Postoperatively at home, pain medications are needed approximately 60% of the time for an average of 3-4 days. Average recovery is 5-6 days. • Success: Chance that you are stone-free from the procedure. • Complications: Infection, fever, bleeding requiring transfusion, injury to the ureter, ureteral stricture, and blockage of the ureter. • Stent: A stent is a thin plastic tube that is inserted into the ureter during surgery to drain the kidney and help small stone fragments pass. Stents stay in place from a few days to several weeks. The stent is either removed at home by the patient or in the office by the urologist with a small telescope.
Scenario: You are diagnosed with a stone in your ureter (the tube that drains the kidney). You are provided the treatment options of ureteroscopy or shock wave lithotripsy. The below table compares the two procedures:
TREATMENT
Ureteroscopy Shock Wave Lithotripsy
SUCCESS (stone-free)
COMPLICATIONS
NEED FOR STENT AT TIME OF SURGERY
92% 77%
16% 9%
39% 16%
NEED FOR 2 SURGERY
3% 21%
1. Which procedure would you choose? (please CIRCLE ONE)
a. Ureteroscopy
b. Shock wave lithotripsy
2. In this scenario, please CIRCLE how important EACH factor was in making your decision. (Rank: 5 is extremely important and 1 is not important) Not important at all
Factor
Small amount of importance
Moderate importance
Large importance
Extremely important, would not compromise
Success
1
2
3
4
5
Complications
1
2
3
4
5
Need for stent
1
2
3
4
5
1
2
3
4
5
1
2
3
4
5
Need for 2 surgery
nd
Other ______________
ND
Patient Preference for Ureteroscopy versus Shock Wave Lithotripsy
References 1. Scales CD, Smith AC, Hanley JM et al: Prevalence of kidney stones in the United States. Eur Urol 2012; 62: 160. 2. Preminger GM, Tiselius HG, Assimos DG et al: 2007 Guideline for the management of ureteral calculi. Eur Urol 2007; 52: 1610. 3. Türk C, Knoll T, Petrik A et al: Guidelines on Urolithiasis. Arnhem, The Netherlands: European Association of Urology 2011. 4. Aboumarzouk OM, Kata SG, Keeley FX et al: Extracorporeal shock wave lithotripsy (ESWL) versus ureteroscopic management for ureteric calculi. Cochrane Database Syst Rev 2012; 5: CD006029. 5. Childs MA, Rangel LJ, Lingeman JE et al: Factors influencing urologist treatment preference in surgical management of stone disease. Urology 2012; 79: 996.
429
6. Scales CD, Krupski TL, Curtis LH et al: Practice variation in the surgical management of urinary lithiasis. J Urol 2011; 186: 146. 7. Ghalayini IF, Al-Ghazo MA and Khader YS: Extracorporeal shockwave lithotripsy versus ureteroscopy for distal ureteric calculi: efficacy and patient satisfaction. Int Braz J Urol 2006; 32: 656. 8. Barry MJ and Edgman-Levitan S: Shared decision makingepinnacle of patient-centered care. N Engl J Med 2012; 366: 780. 9. Stiggelbout AM, Van der Weijden T, De Wit MP et al: Shared decision making: really putting patients at the centre of healthcare. BMJ 2012; 344: e256. 10. Oshima Lee E and Emanuel EJ: Shared decision making to improve care and reduce costs. N Engl J Med 2013; 368: 6. 11. Matlaga BR, Jansen JP, Meckley LM et al: Economic outcomes of treatment for ureteral and renal stones: a systematic literature review. J Urol 2012; 188: 449.