A Novel Decision Aid to Support Informed Decision-Making Process in Patients with a Symptomatic Nonlower Pole Renal Stone <20 mm in Diameter

Introduction

Stone disease is reported to have a prevalence of 8.8% in the United States, ¹ and its prevalence has been reported to be even higher in other parts of the world. ² In accordance with its up to 50% rate of recurrence and impact on both quality of life and renal functions, appropriate management of stone disease is an important issue.

The most recent American Urological Association (AUA) and European Association of Urology (EAU) guidelines offer either extracorporeal shockwave lithotripsy (SWL) or retrograde intrarenal surgery (RIRS) for the first-line management of nonlower pole renal stones <20 mm in diameter. ^3,4 These two treatment modalities have unique advantages and disadvantages, and the decision-making process depends on a number factors regarding both the patient's and physicians' sides. However, the AUA guidelines emphasize the importance of shared decision making for this particular patient group. ³

Recently, Omar and colleagues evaluated the factors that affect patients' preferences on choosing SWL or ureteroscopy for management of an asymptomatic 8 mm stone and detected a number of factors. However, the authors concluded that patients' preferences mainly rely on physicians' recommendations. ⁵ The physicians should further facilitate the involvement of patient in the decision-making process, and this necessitates appropriate tools for patient education. Decision aids (DAs) are tools that are designed to educate patients on treatment options and possible outcomes. By improving patients' level of knowledge, DAs assist patients while making informed decisions about their treatment options. ⁶

DAs have already been in use in urologists' practice, especially for screening and management of prostate cancer, and were shown to have a positive impact on increasing patients' level of knowledge and to aid in the informed decision-making process even in the under-educated populations. ^7,8 However, currently, to the best of our knowledge, no DAs are available for stone disease and in this study, we aimed at developing the first DA for decision making in treatment of symptomatic nonlower pole renal stones <20 mm in diameter.

Materials and Methods

The DA development process was established based on the Ottawa Personal Decision Guide. ⁹ The aim of this guide is to help physicians who deal with patients who are expected to make decisions and have difficulty in the decision-making process. In addition, a previously released guide: “Workbook on Developing and Evaluating Patient Decision Aids” was investigated and seven steps for developing a DA were followed. ¹⁰ We further evaluated the DA in accordance with the criteria of International Patient Decision Aid Standards (IPDAS) Collaboration. IPDAS is a multinational collaboration that developed the standards for DAs. ¹¹

The content of the DA was planned to include information on the following:

1. General characteristics of the stone disease.

Information on the success and complication rates of the SWL and RIRS procedures was gathered from the most recent EAU and AUA guidelines. ^3,4 The text was designed as a booklet, and the booklet was sent to three different urologists who have substantial experience on stone disease. These urologists provided feedback about the information provided by the DA and also the structure and linguistic properties. The DA was revised based on these feedbacks.

After the establishment of the revised version of the DA, Delphi group assessment was performed. In this stage, the DA was sent to three different urologists and they evaluated the DA by the guidance of the IPDAS instrument checklist. This checklist maintains the objective evaluation of a DA in three distinct parts: content, process development, and overall effectiveness. The urologists included in the Delphi group assessment initially evaluated the DA individually; then, they further evaluated as a group to reach the final scores.

In the last step, the DA was given to 25 patients with a nonlower pole renal stone <20 mm in diameter. All of these patients had an education level of at least elementary school and were able to read and write in Turkish language. After reading the DA, the patients were asked to complete a questionnaire to evaluate the DA. A five-point Likert scale was used to answer the questions. This questionnaire included the following questions:

1. Was the amount of information sufficient?

The patients were also given a blank space to note their further suggestions to make the DA better. They were also suggested to ask any information that they had difficulty in understanding to make linguistic corrections. Further revisions were done, especially on the language content medical terms used.

In terms of statistical analysis, no statistical tests were performed. The results of the IPDAS instrument checklist and the patient questionnaires were all provided as descriptives.

Results

The final version of the DA consisted of three main parts. The first part started with the aim of the DA and provided general information about stone disease; its prevalence, pathophysiology, and long-term consequences. In the second part, technique, success rate, and complication rate of the SWL were described. The third part focused on the technique, success rate, and complication rate of the RIRS procedure. The DA is written in Turkish language, and the English translation is provided as Supplementary Data (Supplementary Data are available online at www.liebertpub.com/end).

In the initial evaluation of the DA by three urologists, some suggestions on the scientific data, linguistic properties, and design of the DA were made and further revisions were made. The Delphi group assessment was performed in the next step and resulted in favorable scores. For the content scale, a score of 24/27; for the development process, a score of 20/21; for the effectiveness, a score of 6/6; and in total, a score of 50/54 were established. The scores provided by each expert and the total scores are summarized in Table 1.

The final evaluation of the DA was performed by 25 patients. The mean age of the group was 46 ± 6.6, and 14 (56%) of the patients were men. Regarding the educational status, 8 (32%) of the patients had an elementary school degree, 11 (44%) of the patients had a high school degree, and 6 (24%) patients had a college degree. Regarding occupational status, 16 (64%) patients were employed, 5 (20%) patients were retired, and 4 (16%) were unemployed. The patients responded with favorable scores to the questions, and the mean scores for each question are summarized in Table 2.

Discussion

In this study, we developed a novel DA to increase the level of knowledge of the patients and to help them in deciding for a treatment in case of a symptomatic nonlower pole renal stone <20 mm. To the best of our knowledge, this is the first DA developed in the era of stone disease and the DA was accepted favorably by the patients.

In the DA, we took into account the two treatment modalities: SWL and RIRS for the treatment of nonlower pole renal stones <20 mm. These two treatments are suggested by the EAU and AUA guidelines for this particular scenario and are already applied successfully worldwide. ^3,4 Both of these treatment choices have their own advantages and disadvantages, and patients should be able to decide on one over the other after establishing an adequate level of knowledge on the condition and taking into account their personal needs.

In the most recent AUA guidelines, nonlower pole renal stones <20 mm was evaluated as an index patient (Index patient 7 in the AUA guidelines) and indicated both SWL and RIRS as successful treatments options. Both of these options have less morbidity when compared with percutaneous nephrolithotomy. The guideline committee also emphasized the less likelihood of the repeat procedure in case of RIRS and mentioned that the final decision should rely on a shared decision-making approach. ³

In a recent study, Omar and colleagues aimed at finding out factors affecting patient decision making in case of a hypothetical 8 mm asymptomatic lower calyx stone, to help guide a shared medical decision-making approach. ⁵ In this study, the authors evaluated whether several factors have an effect or not on decision making, but one of the most attractive results of this study was that 85% of the patients reported relying on the physician's recommendations for the treatment modality. This result especially emphasizes the importance of patient education to facilitate patients' contribution to the shared decision-making process.

DAs have been used in medicine for more than two decades; they help patients in their decisions when there is more than one reasonable option, and each option has its own benefits and harms that patients may value differently. A recent Cochrane review on DAs concluded that DAs aid in improving patients' level of knowledge on treatment options, and reduce their decisional conflict related to feeling uninformed and unclear about their personal values. In addition, DAs stimulate patients to take a more active role in the decision-making process. ¹² Therefore, we think that it is evident that DAs are needed in the era of stone disease where more than one option, from observation to invasive surgical procedures, is almost always relevant in different scenarios.

While developing the DA, we followed the recommended guide ¹⁰ and further evaluated the DA (Delphi group assessment) in accordance with the IPDAS criteria. ¹¹ This evaluation provided a favorable result that our DA got a total score of 50/54. The patient evaluation stage also resulted favorable results, and most of the patients also recommended the DA to other patients in the same condition. However, the decision-making process is also influenced by patient preferences as well, and the results of DA must be confronted with post-procedure outcomes. In the following step, a prospective randomized trial to compare with standard of care is planned. In this step, direct comparison for increasing patients' level of knowledge and level of decisional conflict by a previously defined decisional conflict scale ¹³ will be performed.

Conclusions

This novel DA for patients with a symptomatic nonlower pole renal stone <20 mm showed promising results and was well accepted by the patients. We believe that this DA will have a positive impact on patients' level of knowledge on stone disease and the particular treatment options, SWL and RIRS. An increased level of knowledge has the potential to improve the patients' contribution to the shared decision-making process. A further prospective randomized trial to compare with the standard patient-informing process is also planned.