- Email: [email protected]
Shared Decision Making for Urolithiasis: The Use of a Patient Decision Making Aid
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urologypracticejournal.com
Shared Decision Making in Urolithiasis: The Use of a Patient Decision Making Aid Necole M. Streeper,* Brian C. Sninsky, Kristina L. Penniston, Sara L. Best and Stephen Y. Nakada From the Department of Urology, School of Medicine and Public Health, University of Wisconsin, Madison, Wisconsin
Abstract
Abbreviations and Acronyms
Introduction: Patients desire an active role in health care decisions. We evaluated whether a patient decision making aid is useful when considering surgical treatment for urolithiasis. Methods: Patients with a history of urolithiasis were recruited for study. They were asked to consider a hypothetical case of an asymptomatic 10 mm proximal ureteral stone for which elective surgical intervention was recommended. Shock wave lithotripsy and ureteroscopy were presented as potential options. A patient decision making aid was developed to explain and compare the options. A urologist presented the information to the patients, once using the patient decision making aid and then without the aid. We assessed participant satisfaction with each format and invited comments about the aid and its content, design and clarity.
PDMA = patient decision making aid SWL = shock wave lithotripsy URS = ureteroscopy
Results: Mean SD age of the 4 male and 10 female participants was 61 9 years. Of the participants 86% found the patient decision making aid helpful but identified areas for improvement. Specifically, patients wanted more information on stent placement, stent discomfort, long-term effects and cost. Of the participants 79% reported that the aid improved their understanding of the treatment options compared to the session without the aid. While 8 of 14 participants preferred hearing surgeon recommendations, most still reported value in the patient decision making aid. Conclusions: Patient decision making aids are increasingly used in the management of several diseases and they require patient input into development. In our study the aid improved patient selfreported understanding of surgical options for ureteral stone removal. Notably, most participants still preferred to make decisions based on the surgeon recommendation. Modification of the patient decision making aid based on patient suggestions will enhance its usefulness and applicability in the clinical setting. Key Words: urolithiasis, patients, clinical decision-making, lithotripsy, ureteroscopy
Submitted for publication June 2, 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; 2352-0779/16/34-1/0 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, School of Medicine and Public Health, University of Wisconsin, 1685 Highland Ave., MFCB-3267, Madison, Wisconsin 53708 (telephone: 210-621-5037; FAX: 608-262-6453; e-mail address: [email protected]).
RESEARCH, INC.
http://dx.doi.org/10.1016/j.urpr.2015.07.011 Vol. 3, 1-7, July 2016 Published by Elsevier
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Shared Decision Making in Urolithiasis
The dynamics of the patient-physician relationship have evolved in recent years with increased emphasis on patient education and involvement in shared decision making. PDMAs, which are stools intended to facilitate this process, are becoming increasingly popular. This type of aid is thought to help patients make a fully informed decision about therapy, especially in situations in which more than 1 suitable option exists. Currently PDMAs are not routinely used for surgical management decision making in urolithiasis. PDMAs are formatted as written materials, videos or online platforms designed to educate patients and their families about care options, including outcomes, benefits, risks and cost.1,2 PDMAs are often used to compare equivalent or equally acceptable options. Key features of PDMA development include the involvement of patients and clinicians in the design and development of a prototype, alpha testing with patients and clinicians, field testing in the clinical setting, production of a final version, evaluation and validation.3 In particular, patient input regarding content, design and clarity of the aid is considered crucial prior to utilization in the clinical setting. We evaluated whether a PDMA would be useful to patients with a history of urolithiasis who make decisions regarding surgical treatment. The secondary purpose of this study was to gather patient input for further modification of the PDMA before clinical use. Materials and Methods
Adult patients (older than 18 years) with a history of urolithiasis were recruited from our urology clinics from September to October 2013. Participants attended 1 of 3 evening sessions, each lasting approximately 1 to 1.5 hours. The study format was designed so that each participant was presented with information about the treatment options by a urologist, once using the PDMA and once without the aid, with randomization of the format order. A questionnaire was administered after each format was presented to assess satisfaction with each presentation format and the degree of understanding of the advantages and disadvantages of each procedure. At the conclusion we had an informal discussion to gather patient input to improve the design and content of the PDMA. During each session the participants were initially presented with a hypothetical scenario describing an asymptomatic left 10 mm proximal ureteral stone for which surgical treatment was recommended. An illustration was provided to participants to explain urinary system anatomy and stone location.
The PDMA prototype was developed according to 148 IPDAS (International Patient Decision Aids Standards) 149 principles and based on the design of aids for other 150 medical conditions (fig. 1).3 The PDMA was constructed ½F1151 with a goal of complementing the information provided 152 by the surgeon about factors associated with treatment 153 options. In the PDMA the surgical options were 154 described in a balanced manner and in plain language 155 written at an eighth-grade level. SWL and URS were 156 described side by side on a handout with text headings of 157 “surgery consists of,” “what to expect post procedure,” 158 “possible advantages include” and “possible disadvan- 159 tages include.” Diagrams were included on the aid to 160 help patients visualize the relevant anatomy and the 161 162 surgical procedure. Participants in each session were then presented with 163 information on SWL and URS in 2 formats and were told 164 that either treatment option was acceptable in this hypo- 165 thetical scenario. In 1 format participants received verbal 166 explanations from the urologist about the 2 procedures with 167 their advantages and disadvantages, similar to what would 168 be done in a clinical setting without a visual aid. In the 169 second format the urologist reviewed the same type of 170 information but used the visual aid of the PDMA to 171 guide the explanation. Both formats included a script to 172 ensure standardization among the 3 evening sessions. All 173 174 participants were presented with information using both formats. Figure 2 shows details of the session sequence ½F2175 176 of events. During both presentation formats SWL was described as 177 a noninvasive, approximately 1-hour outpatient surgery 178 using general anesthesia in which shock waves are gener- 179 ated outside the body and directed at the stone to break it 180 into smaller fragments under x-ray guidance. Participants 181 were told that they could return to work after 2 days and 182 there is typically minimal pain postoperatively. Participants 183 were told that there is typically no need to place a ureteral 184 stent after SWL and the success rate is approximately 77%. 185 Patients were advised that secondary procedures may be 186 187 necessary.4 URS was described as a minimally invasive outpa- 188 tient surgery in which a scope would be inserted 189 through the urinary system to visualize the stone and a 190 laser fiber would fragment the stone into smaller pieces. 191 They were told that surgery would take approximately 1 192 hour using general anesthesia. Participants were told 193 that they could return to work in approximately 2 days. 194 We discussed that a ureteral stent is typically placed 195 for 3 to 5 days as part of this surgery and bothersome 196 symptoms from the stent are common. The success rate 197 of this approach was discussed as greater than 92% for 198
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Figure 1. PDMA for surgical treatment of nephrolithiasis
a stone of the size and location described in the study scenario.4 At the end of each presentation the participants were asked to complete a questionnaire assessing satisfaction with each presentation format and the degree of understanding of the advantages and disadvantages of each procedure. They were also asked to choose the procedure that they would select (URS vs SWL). After participants had heard both presentation styles they were given a third questionnaire to assess their preference of the format in which the information was provided, ie with or without the PDMA. After the session concluded we invited participants to comment on the design, content and clarity of the PDMA and offer suggestions for improvement.
Results
The 4 male and 10 female participants were a mean SD of 61 9 years old. The average number of prior stone events was 8 13 (range 1 to 50). Of the participants 13.79% had a history of surgical intervention for stones, including SWL in 57%, URS in 57% and percutaneous nephrolithotomy in 7%, while 21% had no history of stone surgery. Of the participants 36% had no history of stent placement, 43% had 1 prior stent placement and 21% had 5 to 7 prior stent placements. Four patients had only 1 prior stone episode, 8 had 10 or fewer and 2 had greater than 10 episodes. The highest level of education completed was college in 50% of participants, graduate school in 43% (total of 93% with a college education) and high school in 7%.
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Shared Decision Making in Urolithiasis
Introduction and Case Scenario
Format #1: Discussion with use of PDMA or Discussion without PDMA
Questionnaire # 1
Format # 2- Discussion without PDMA or Discussion with use of PDMA
Questionnaire # 2
Questionnaire # 3
Participant Comment Session Figure 2. Session sequence of events
Of the 14 participants 12 (86%) found that the PDMA was useful to help make an informed decision and 2 were undecided (fig. 3). Of the participants 79% preferred the PDMA to the discussion format without the aid and the others had no preference about how the information was given. Participants reported that the PDMA helped them understand the treatment options more clearly. The PDMA did not impact the participant perceived understanding of the advantages and disadvantages of each procedure. There was also no difference in the procedure chosen with the majority of patients choosing URS. Interestingly, 8 of 14 participants (57%) still preferred to base the treatment decision on the surgeon recommendation but, nonetheless, they reported a role for the PDMA in the process.
During the comment session participants made suggestions on how to improve the PDMA. Participants reported that they would like the PDMA to include a comparison of health care costs, websites with references for further information, and more statistical outcomes and possible longterm effects. They also suggested format changes, including 1 page for each procedure instead of side-by-side information to include more details and provide space for patients to write questions during their appointment. Discussion
Our study shows that patients prefer the inclusion of a PDMA to guide treatment decisions about the surgical
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Patients increasingly desire to have an active role in the 454 management of their health. Shared decision making bene- 455 100.0% fits the patient and the health care provider, and has the 456 85.7% Yes potential to improve care, increase patient satisfaction, and 457 80.0% Unsure establish more reasonable expectations for outcomes and 458 No lower cost.5 PDMAs are becoming more popular across the 459 60.0% field of medicine to supplement and reinforce the informa- 460 40.0% 461 tion provided during clinical discussion (see table).6e11 ½T1 Other investigations have found that patients prefer 462 14.3% 20.0% PDMAs during the counseling process and they lead to 463 0.0% increased patient knowledge as well as reduced decisional 464 0.0% 465 conflict.6e11 Braddock et al reported that informed decision making 466 B among visits with primary care physicians and surgeons in 467 an outpatient office setting was often incomplete.12 King 468 90.0% and Moulton argued that traditional informed consent is 469 78.6% 80.0% inadequate to inform patients about treatment options in 470 70.0% preference sensitive decisions.13 This supports the utiliza- 471 60.0% tion of aids that are specifically designed to better inform 472 50.0% patients and facilitate meaningful patient-provider discus- 473 40.0% sions, improving on the standard informed consent process. 474 30.0% With the limited duration of medical appointments it is often 475 21.4% 20.0% difficult to spend ample time explaining and accurately 476 assessing patient understanding of treatment options. An 477 10.0% 0.0% aid allows for a more efficient clinic visit by providing 478 0.0% physicians with a systematic and standardized review of 479 Figure 3. Results. A, PDMA was useful. B, format preference. 0.0%, treatment options in an easily understood format.14 It pro- 480 usual office discussion. Red bar indicates PDMA. Blue bar indicates vides written education material with illustrations that 481 no preference. the patient may take home to further review or discuss 482 with family members, allowing for more time to process the 483 information. Any additional questions that arise may be 484 management of urolithiasis. The aid assisted patients in addressed with a followup telephone call or an appointment 485 making an informed decision, specifically by increasing the at patient or provider discretion. 486 understanding of the disadvantages and advantages of each The development of patient decision making aids has 487 surgical option. While most of our patients still preferred to been previously addressed. The literature shows the impor- 488 make decisions based on the surgeon recommendation, they tance of describing the developmental process of PDMAs. 489 found the PDMA to be helpful in guiding the decision Others reported the need for a process using IDPAS 490 making process. 491 Table. 492 Studies evaluating PDMA for other medical problems 493 References No. Pts Medical Problem Study Type Result 494 Stacey et al6 142 Orthopedic (total knee arthroplasty) Randomized, controlled trial Pts exposed to PDMA achieved higher decision quality 495 based on knowledge (71% vs 47%, p <0.0001) 11 496 Fraenkel et al 11 Cardiology (atrial fibrillation) Tool development Most participants found tool easy to complete þ amount of information provided was adequate 497 Vodermaier et al8 11 Gynecologic oncology (breast Ca) Randomized, controlled trial Pts who used decision aid felt better informed than pts who 498 did not use it (p ¼ 0.06) 9 499 Akl et al 8 Pulmonary (chronic obstructive Tool development Pts showed significant improvement in knowledge with tool pulmonary disorder) use (p ¼ 0.008). 500 Whelan et al10 201 Gynecologic oncology (breast Ca) Randomized, controlled trial Pts who used decision aid had higher knowledge scores 501 (p <0.0001), less decisional conflict (p ¼ 0.02) þ more 502 satisfaction with decision making (p ¼ 0.05). Barry et al7 373 Urology (benign prostatic Cohort Of pts 77% rated shared decision making program 503 hyperplasia) positively 504
Percentage of Patients
A
Percentage of Patients
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Shared Decision Making in Urolithiasis
principles, which includes scoping, the development of a prototype, alpha testing with patients and clinicians to check comprehensibility and usability, beta testing in the clinic to assess feasibility and the production of a final version for clinical use and/or further evaluation.3,15 Another important component of PDMA development is assessing the effectiveness of the decision making process and decision quality.16,17 O’Connor et al performed a meta-analysis of 55 randomized, controlled trials to evaluate the efficacy of decision aids.18 They found that aids improved patient knowledge and decreased the feeling of being uninformed.18 The purpose of our study was to gather patient input in the development of our PDMA and assess whether patients found the information and format to be useful. Additional studies are needed to evaluate the effectiveness of a PDMA to evaluate stone surgery options in the clinical setting. Specifically, evaluating comprehension using the aid, patient weighing of competing factors to make a decision and adapting to an electronic format will be goals of future studies. It will be important for the PDMA to undergo external peer review by urologists not involved in its development. In addition, administration of the aid by a nonurologist would further inform the effectiveness and usefulness of the tool. We also plan to assess whether PDMA use would lead to increased patient satisfaction with the surgical process. In addition, it would be important to identify cultural barriers to providing an effective aid.19 We acknowledge that certain limitations were present in our study. We included a small sample size, which was secondary to the study format asking participants to be available for a 1.5-hour evening session to allow for informal discussion to gather patient input. Participants had a higher education level than the national average with the majority having completed college or graduate level education. Moreover, because participants were self-selected, it is possible that our population may not represent the general patient population. A more diverse group of participants may alter the comprehensibility of and suggestions for improvement of the PDMA. The next step is to incorporate the PDMA into clinical practice, which will offer a larger and more diverse cohort to study. In addition, the majority of the subjects in our study were women, which is atypical of the stone population. Another limitation is that the information provided in the PDMA reflects the preferences of our surgeons, which may differ from practice elsewhere. We recognize that the PDMA may need to be altered to consider the clinical practice of a particular institution as well as the needs and preferences of the population in a given geographic region. Furthermore, the information provided in the aid is meant to serve as a guide during
discussion with the patients. More specific details may be provided depending on the patient interest level. Conclusions
A PDMA for surgical shared decision making was valued by stone formers. It may also be useful for surgeons because it allows for a standardized and systematic way to educate patients, improving the standard informed consent process. Although most patients found the aid to be useful, the majority still preferred to make decisions based on the surgeon recommendation. Suggestions from the participants regarding the PDMA will be incorporated into future investigations to better assess the applicability and effectiveness of the aid. References 1. Wakefield CE, Watts KJ, Meiser B et al: Development and pilot testing of an online screening decision aid for men with a family history of prostate cancer. Patient Educ Couns 2011; 83: 64. 2. Chabrera C, Font A, Caro M et al: Developing a decision aid to support informed choices for newly diagnosed patients with localized prostate cancer. Cancer Nurs 2015; 38: E55. 3. Coulter A, Stilwell D, Kryworuchko J et al: A systematic development process for patient decision aids. BMC Med Inform Decis Mak, suppl., 2013; 13: S1. 4. Aboumarzouk OM, Kata SG, Keeley FX et al: Extracorporeal shock wave lithotripsy (ESWL) versus ureteroscopic management for ureteric calculi. Cochrane Database Syst Rev 2011; 12: CD006029. 5. Oshima EL and Emanuel EJ: Shared decision making to improve care and reduce costs. N Engl J Med 2013; 368: 6. 6. Stacey D, Hawker G, Dervin G et al: Decision aid for patients considering total knee arthroplasty with preference report for surgeons: a pilot randomized controlled trial. BMC Musculoskelet Disord 2014; 15: 54. 7. Barry MJ and Cherkin DC: A randomized trial of a multimedia shared decision-making program for men facing a treatment decision for benign prostatic hyperplasia. Dis Manag Clin Outcomes 1997; 1: 5. 8. Vodermaier A, Caspari C, Koehm J et al: Contextual factors in shared decision making: a randomised controlled trial in women with a strong suspicion of breast cancer. Br J Cancer 2009; 100: 590. 9. Akl EA, Grant BJB, Guyatt GH et al: A decision aid for COPD patients considering inhaled steroid therapy: development and before and after pilot testing. BMC Med Inform Decis Mak 2007; 7: 12. 10. Whelan T, Levine M, Willan A et al: Effect of a decision aid on knowledge and treatment decision making for breast cancer surgery: a randomized trial. JAMA 2004; 292: 435.
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11. Fraenkel L, Street RL Jr and Fried TR: Development of a tool to improve the quality of decision making in atrial fibrillation. BMC Med Inform Decis Mak 2011; 11: 59. 12. Braddock CH III, Edwards KA, Hasenberg NM et al: Informed decision making in outpatient practice: time to get back to basics. JAMA 1999; 282: 2313. 13. King JS and Moulton BW: Rethinking informed consent: the case for shared medical decision-making. Am J Law Med 2006; 32: 529. 14. Hajizadeh N, Perez Figueroa RE, Uhler LM et al: Identifying design considerations for a shared decision aid for use at the point of outpatient clinical care: An ethnographic study at an inner city clinic. J Particip Med 2013; 5: 12. 15. Elwyn G, O’Connor A, Stacey D et al: Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ 2006; 333: 417.
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16. Sepucha KR, Borkhoff CM, Lally J et al: Establishing the effectiveness of patient decision aids: key constructs and measurement instruments. BMC Med Inform Decis Mak, suppl., 2013; 13: S12. 17. Sepucha KR, Matlock DD, Wills CE et al: “It’s valid and reliable” is not enough: critical appraisal of reporting of measures in trials evaluating patient decision aids. Med Decis Making 2014; 34: 560. 18. O’Connor AM, Bennett CL, Stacey D et al: Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2009; 3: CD001431. 19. Alden DL, Friend J, Schapira M et al: Cultural targeting and tailoring of shared decision making technology: a theoretical framework for improving the effectiveness of patient decision aids in culturally diverse groups. Soc Sci Med 2014; 105: 1.
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urologypracticejournal.com
Shared Decision Making in Urolithiasis: The Use of a Patient Decision Making Aid Necole M. Streeper,* Brian C. Sninsky, Kristina L. Penniston, Sara L. Best and Stephen Y. Nakada From the Department of Urology, School of Medicine and Public Health, University of Wisconsin, Madison, Wisconsin
Abstract
Abbreviations and Acronyms
Introduction: Patients desire an active role in health care decisions. We evaluated whether a patient decision making aid is useful when considering surgical treatment for urolithiasis. Methods: Patients with a history of urolithiasis were recruited for study. They were asked to consider a hypothetical case of an asymptomatic 10 mm proximal ureteral stone for which elective surgical intervention was recommended. Shock wave lithotripsy and ureteroscopy were presented as potential options. A patient decision making aid was developed to explain and compare the options. A urologist presented the information to the patients, once using the patient decision making aid and then without the aid. We assessed participant satisfaction with each format and invited comments about the aid and its content, design and clarity.
PDMA = patient decision making aid SWL = shock wave lithotripsy URS = ureteroscopy
Results: Mean SD age of the 4 male and 10 female participants was 61 9 years. Of the participants 86% found the patient decision making aid helpful but identified areas for improvement. Specifically, patients wanted more information on stent placement, stent discomfort, long-term effects and cost. Of the participants 79% reported that the aid improved their understanding of the treatment options compared to the session without the aid. While 8 of 14 participants preferred hearing surgeon recommendations, most still reported value in the patient decision making aid. Conclusions: Patient decision making aids are increasingly used in the management of several diseases and they require patient input into development. In our study the aid improved patient selfreported understanding of surgical options for ureteral stone removal. Notably, most participants still preferred to make decisions based on the surgeon recommendation. Modification of the patient decision making aid based on patient suggestions will enhance its usefulness and applicability in the clinical setting. Key Words: urolithiasis, patients, clinical decision-making, lithotripsy, ureteroscopy
Submitted for publication June 2, 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; 2352-0779/16/34-1/0 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, School of Medicine and Public Health, University of Wisconsin, 1685 Highland Ave., MFCB-3267, Madison, Wisconsin 53708 (telephone: 210-621-5037; FAX: 608-262-6453; e-mail address: [email protected]).
RESEARCH, INC.
http://dx.doi.org/10.1016/j.urpr.2015.07.011 Vol. 3, 1-7, July 2016 Published by Elsevier
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Shared Decision Making in Urolithiasis
The dynamics of the patient-physician relationship have evolved in recent years with increased emphasis on patient education and involvement in shared decision making. PDMAs, which are stools intended to facilitate this process, are becoming increasingly popular. This type of aid is thought to help patients make a fully informed decision about therapy, especially in situations in which more than 1 suitable option exists. Currently PDMAs are not routinely used for surgical management decision making in urolithiasis. PDMAs are formatted as written materials, videos or online platforms designed to educate patients and their families about care options, including outcomes, benefits, risks and cost.1,2 PDMAs are often used to compare equivalent or equally acceptable options. Key features of PDMA development include the involvement of patients and clinicians in the design and development of a prototype, alpha testing with patients and clinicians, field testing in the clinical setting, production of a final version, evaluation and validation.3 In particular, patient input regarding content, design and clarity of the aid is considered crucial prior to utilization in the clinical setting. We evaluated whether a PDMA would be useful to patients with a history of urolithiasis who make decisions regarding surgical treatment. The secondary purpose of this study was to gather patient input for further modification of the PDMA before clinical use. Materials and Methods
Adult patients (older than 18 years) with a history of urolithiasis were recruited from our urology clinics from September to October 2013. Participants attended 1 of 3 evening sessions, each lasting approximately 1 to 1.5 hours. The study format was designed so that each participant was presented with information about the treatment options by a urologist, once using the PDMA and once without the aid, with randomization of the format order. A questionnaire was administered after each format was presented to assess satisfaction with each presentation format and the degree of understanding of the advantages and disadvantages of each procedure. At the conclusion we had an informal discussion to gather patient input to improve the design and content of the PDMA. During each session the participants were initially presented with a hypothetical scenario describing an asymptomatic left 10 mm proximal ureteral stone for which surgical treatment was recommended. An illustration was provided to participants to explain urinary system anatomy and stone location.
The PDMA prototype was developed according to 148 IPDAS (International Patient Decision Aids Standards) 149 principles and based on the design of aids for other 150 medical conditions (fig. 1).3 The PDMA was constructed ½F1151 with a goal of complementing the information provided 152 by the surgeon about factors associated with treatment 153 options. In the PDMA the surgical options were 154 described in a balanced manner and in plain language 155 written at an eighth-grade level. SWL and URS were 156 described side by side on a handout with text headings of 157 “surgery consists of,” “what to expect post procedure,” 158 “possible advantages include” and “possible disadvan- 159 tages include.” Diagrams were included on the aid to 160 help patients visualize the relevant anatomy and the 161 162 surgical procedure. Participants in each session were then presented with 163 information on SWL and URS in 2 formats and were told 164 that either treatment option was acceptable in this hypo- 165 thetical scenario. In 1 format participants received verbal 166 explanations from the urologist about the 2 procedures with 167 their advantages and disadvantages, similar to what would 168 be done in a clinical setting without a visual aid. In the 169 second format the urologist reviewed the same type of 170 information but used the visual aid of the PDMA to 171 guide the explanation. Both formats included a script to 172 ensure standardization among the 3 evening sessions. All 173 174 participants were presented with information using both formats. Figure 2 shows details of the session sequence ½F2175 176 of events. During both presentation formats SWL was described as 177 a noninvasive, approximately 1-hour outpatient surgery 178 using general anesthesia in which shock waves are gener- 179 ated outside the body and directed at the stone to break it 180 into smaller fragments under x-ray guidance. Participants 181 were told that they could return to work after 2 days and 182 there is typically minimal pain postoperatively. Participants 183 were told that there is typically no need to place a ureteral 184 stent after SWL and the success rate is approximately 77%. 185 Patients were advised that secondary procedures may be 186 187 necessary.4 URS was described as a minimally invasive outpa- 188 tient surgery in which a scope would be inserted 189 through the urinary system to visualize the stone and a 190 laser fiber would fragment the stone into smaller pieces. 191 They were told that surgery would take approximately 1 192 hour using general anesthesia. Participants were told 193 that they could return to work in approximately 2 days. 194 We discussed that a ureteral stent is typically placed 195 for 3 to 5 days as part of this surgery and bothersome 196 symptoms from the stent are common. The success rate 197 of this approach was discussed as greater than 92% for 198
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Figure 1. PDMA for surgical treatment of nephrolithiasis
a stone of the size and location described in the study scenario.4 At the end of each presentation the participants were asked to complete a questionnaire assessing satisfaction with each presentation format and the degree of understanding of the advantages and disadvantages of each procedure. They were also asked to choose the procedure that they would select (URS vs SWL). After participants had heard both presentation styles they were given a third questionnaire to assess their preference of the format in which the information was provided, ie with or without the PDMA. After the session concluded we invited participants to comment on the design, content and clarity of the PDMA and offer suggestions for improvement.
Results
The 4 male and 10 female participants were a mean SD of 61 9 years old. The average number of prior stone events was 8 13 (range 1 to 50). Of the participants 13.79% had a history of surgical intervention for stones, including SWL in 57%, URS in 57% and percutaneous nephrolithotomy in 7%, while 21% had no history of stone surgery. Of the participants 36% had no history of stent placement, 43% had 1 prior stent placement and 21% had 5 to 7 prior stent placements. Four patients had only 1 prior stone episode, 8 had 10 or fewer and 2 had greater than 10 episodes. The highest level of education completed was college in 50% of participants, graduate school in 43% (total of 93% with a college education) and high school in 7%.
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Shared Decision Making in Urolithiasis
Introduction and Case Scenario
Format #1: Discussion with use of PDMA or Discussion without PDMA
Questionnaire # 1
Format # 2- Discussion without PDMA or Discussion with use of PDMA
Questionnaire # 2
Questionnaire # 3
Participant Comment Session Figure 2. Session sequence of events
Of the 14 participants 12 (86%) found that the PDMA was useful to help make an informed decision and 2 were undecided (fig. 3). Of the participants 79% preferred the PDMA to the discussion format without the aid and the others had no preference about how the information was given. Participants reported that the PDMA helped them understand the treatment options more clearly. The PDMA did not impact the participant perceived understanding of the advantages and disadvantages of each procedure. There was also no difference in the procedure chosen with the majority of patients choosing URS. Interestingly, 8 of 14 participants (57%) still preferred to base the treatment decision on the surgeon recommendation but, nonetheless, they reported a role for the PDMA in the process.
During the comment session participants made suggestions on how to improve the PDMA. Participants reported that they would like the PDMA to include a comparison of health care costs, websites with references for further information, and more statistical outcomes and possible longterm effects. They also suggested format changes, including 1 page for each procedure instead of side-by-side information to include more details and provide space for patients to write questions during their appointment. Discussion
Our study shows that patients prefer the inclusion of a PDMA to guide treatment decisions about the surgical
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Shared Decision Making in Urolithiasis
Patients increasingly desire to have an active role in the 454 management of their health. Shared decision making bene- 455 100.0% fits the patient and the health care provider, and has the 456 85.7% Yes potential to improve care, increase patient satisfaction, and 457 80.0% Unsure establish more reasonable expectations for outcomes and 458 No lower cost.5 PDMAs are becoming more popular across the 459 60.0% field of medicine to supplement and reinforce the informa- 460 40.0% 461 tion provided during clinical discussion (see table).6e11 ½T1 Other investigations have found that patients prefer 462 14.3% 20.0% PDMAs during the counseling process and they lead to 463 0.0% increased patient knowledge as well as reduced decisional 464 0.0% 465 conflict.6e11 Braddock et al reported that informed decision making 466 B among visits with primary care physicians and surgeons in 467 an outpatient office setting was often incomplete.12 King 468 90.0% and Moulton argued that traditional informed consent is 469 78.6% 80.0% inadequate to inform patients about treatment options in 470 70.0% preference sensitive decisions.13 This supports the utiliza- 471 60.0% tion of aids that are specifically designed to better inform 472 50.0% patients and facilitate meaningful patient-provider discus- 473 40.0% sions, improving on the standard informed consent process. 474 30.0% With the limited duration of medical appointments it is often 475 21.4% 20.0% difficult to spend ample time explaining and accurately 476 assessing patient understanding of treatment options. An 477 10.0% 0.0% aid allows for a more efficient clinic visit by providing 478 0.0% physicians with a systematic and standardized review of 479 Figure 3. Results. A, PDMA was useful. B, format preference. 0.0%, treatment options in an easily understood format.14 It pro- 480 usual office discussion. Red bar indicates PDMA. Blue bar indicates vides written education material with illustrations that 481 no preference. the patient may take home to further review or discuss 482 with family members, allowing for more time to process the 483 information. Any additional questions that arise may be 484 management of urolithiasis. The aid assisted patients in addressed with a followup telephone call or an appointment 485 making an informed decision, specifically by increasing the at patient or provider discretion. 486 understanding of the disadvantages and advantages of each The development of patient decision making aids has 487 surgical option. While most of our patients still preferred to been previously addressed. The literature shows the impor- 488 make decisions based on the surgeon recommendation, they tance of describing the developmental process of PDMAs. 489 found the PDMA to be helpful in guiding the decision Others reported the need for a process using IDPAS 490 making process. 491 Table. 492 Studies evaluating PDMA for other medical problems 493 References No. Pts Medical Problem Study Type Result 494 Stacey et al6 142 Orthopedic (total knee arthroplasty) Randomized, controlled trial Pts exposed to PDMA achieved higher decision quality 495 based on knowledge (71% vs 47%, p <0.0001) 11 496 Fraenkel et al 11 Cardiology (atrial fibrillation) Tool development Most participants found tool easy to complete þ amount of information provided was adequate 497 Vodermaier et al8 11 Gynecologic oncology (breast Ca) Randomized, controlled trial Pts who used decision aid felt better informed than pts who 498 did not use it (p ¼ 0.06) 9 499 Akl et al 8 Pulmonary (chronic obstructive Tool development Pts showed significant improvement in knowledge with tool pulmonary disorder) use (p ¼ 0.008). 500 Whelan et al10 201 Gynecologic oncology (breast Ca) Randomized, controlled trial Pts who used decision aid had higher knowledge scores 501 (p <0.0001), less decisional conflict (p ¼ 0.02) þ more 502 satisfaction with decision making (p ¼ 0.05). Barry et al7 373 Urology (benign prostatic Cohort Of pts 77% rated shared decision making program 503 hyperplasia) positively 504
Percentage of Patients
A
Percentage of Patients
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Shared Decision Making in Urolithiasis
principles, which includes scoping, the development of a prototype, alpha testing with patients and clinicians to check comprehensibility and usability, beta testing in the clinic to assess feasibility and the production of a final version for clinical use and/or further evaluation.3,15 Another important component of PDMA development is assessing the effectiveness of the decision making process and decision quality.16,17 O’Connor et al performed a meta-analysis of 55 randomized, controlled trials to evaluate the efficacy of decision aids.18 They found that aids improved patient knowledge and decreased the feeling of being uninformed.18 The purpose of our study was to gather patient input in the development of our PDMA and assess whether patients found the information and format to be useful. Additional studies are needed to evaluate the effectiveness of a PDMA to evaluate stone surgery options in the clinical setting. Specifically, evaluating comprehension using the aid, patient weighing of competing factors to make a decision and adapting to an electronic format will be goals of future studies. It will be important for the PDMA to undergo external peer review by urologists not involved in its development. In addition, administration of the aid by a nonurologist would further inform the effectiveness and usefulness of the tool. We also plan to assess whether PDMA use would lead to increased patient satisfaction with the surgical process. In addition, it would be important to identify cultural barriers to providing an effective aid.19 We acknowledge that certain limitations were present in our study. We included a small sample size, which was secondary to the study format asking participants to be available for a 1.5-hour evening session to allow for informal discussion to gather patient input. Participants had a higher education level than the national average with the majority having completed college or graduate level education. Moreover, because participants were self-selected, it is possible that our population may not represent the general patient population. A more diverse group of participants may alter the comprehensibility of and suggestions for improvement of the PDMA. The next step is to incorporate the PDMA into clinical practice, which will offer a larger and more diverse cohort to study. In addition, the majority of the subjects in our study were women, which is atypical of the stone population. Another limitation is that the information provided in the PDMA reflects the preferences of our surgeons, which may differ from practice elsewhere. We recognize that the PDMA may need to be altered to consider the clinical practice of a particular institution as well as the needs and preferences of the population in a given geographic region. Furthermore, the information provided in the aid is meant to serve as a guide during
discussion with the patients. More specific details may be provided depending on the patient interest level. Conclusions
A PDMA for surgical shared decision making was valued by stone formers. It may also be useful for surgeons because it allows for a standardized and systematic way to educate patients, improving the standard informed consent process. Although most patients found the aid to be useful, the majority still preferred to make decisions based on the surgeon recommendation. Suggestions from the participants regarding the PDMA will be incorporated into future investigations to better assess the applicability and effectiveness of the aid. References 1. Wakefield CE, Watts KJ, Meiser B et al: Development and pilot testing of an online screening decision aid for men with a family history of prostate cancer. Patient Educ Couns 2011; 83: 64. 2. Chabrera C, Font A, Caro M et al: Developing a decision aid to support informed choices for newly diagnosed patients with localized prostate cancer. Cancer Nurs 2015; 38: E55. 3. Coulter A, Stilwell D, Kryworuchko J et al: A systematic development process for patient decision aids. BMC Med Inform Decis Mak, suppl., 2013; 13: S1. 4. Aboumarzouk OM, Kata SG, Keeley FX et al: Extracorporeal shock wave lithotripsy (ESWL) versus ureteroscopic management for ureteric calculi. Cochrane Database Syst Rev 2011; 12: CD006029. 5. Oshima EL and Emanuel EJ: Shared decision making to improve care and reduce costs. N Engl J Med 2013; 368: 6. 6. Stacey D, Hawker G, Dervin G et al: Decision aid for patients considering total knee arthroplasty with preference report for surgeons: a pilot randomized controlled trial. BMC Musculoskelet Disord 2014; 15: 54. 7. Barry MJ and Cherkin DC: A randomized trial of a multimedia shared decision-making program for men facing a treatment decision for benign prostatic hyperplasia. Dis Manag Clin Outcomes 1997; 1: 5. 8. Vodermaier A, Caspari C, Koehm J et al: Contextual factors in shared decision making: a randomised controlled trial in women with a strong suspicion of breast cancer. Br J Cancer 2009; 100: 590. 9. Akl EA, Grant BJB, Guyatt GH et al: A decision aid for COPD patients considering inhaled steroid therapy: development and before and after pilot testing. BMC Med Inform Decis Mak 2007; 7: 12. 10. Whelan T, Levine M, Willan A et al: Effect of a decision aid on knowledge and treatment decision making for breast cancer surgery: a randomized trial. JAMA 2004; 292: 435.
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11. Fraenkel L, Street RL Jr and Fried TR: Development of a tool to improve the quality of decision making in atrial fibrillation. BMC Med Inform Decis Mak 2011; 11: 59. 12. Braddock CH III, Edwards KA, Hasenberg NM et al: Informed decision making in outpatient practice: time to get back to basics. JAMA 1999; 282: 2313. 13. King JS and Moulton BW: Rethinking informed consent: the case for shared medical decision-making. Am J Law Med 2006; 32: 529. 14. Hajizadeh N, Perez Figueroa RE, Uhler LM et al: Identifying design considerations for a shared decision aid for use at the point of outpatient clinical care: An ethnographic study at an inner city clinic. J Particip Med 2013; 5: 12. 15. Elwyn G, O’Connor A, Stacey D et al: Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ 2006; 333: 417.
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16. Sepucha KR, Borkhoff CM, Lally J et al: Establishing the effectiveness of patient decision aids: key constructs and measurement instruments. BMC Med Inform Decis Mak, suppl., 2013; 13: S12. 17. Sepucha KR, Matlock DD, Wills CE et al: “It’s valid and reliable” is not enough: critical appraisal of reporting of measures in trials evaluating patient decision aids. Med Decis Making 2014; 34: 560. 18. O’Connor AM, Bennett CL, Stacey D et al: Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2009; 3: CD001431. 19. Alden DL, Friend J, Schapira M et al: Cultural targeting and tailoring of shared decision making technology: a theoretical framework for improving the effectiveness of patient decision aids in culturally diverse groups. Soc Sci Med 2014; 105: 1.
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