Systematic Review of Decision Aids for Newly Diagnosed Patients with Prostate Cancer Making Treatment Decisions

Author's Accepted Manuscript Systematic Review of Decision Aids for Newly Diagnosed Prostate Cancer Patients Making Treatment Decisions Prajakta Adsul , Ricardo Wray , Kyle Spradling , Oussama Darwish , Nancy Weaver , Sameer Siddiqui

PII: DOI: Reference:

S0022-5347(15)04115-4 10.1016/j.juro.2015.05.093 JURO 12665

To appear in: The Journal of Urology Accepted Date: 28 May 2015 Please cite this article as: Adsul P, Wray R, Spradling K, Darwish O, Weaver N, Siddiqui S, Systematic Review of Decision Aids for Newly Diagnosed Prostate Cancer Patients Making Treatment Decisions, The Journal of Urology® (2015), doi: 10.1016/j.juro.2015.05.093. DISCLAIMER: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our subscribers we are providing this early version of the article. The paper will be copy edited and typeset, and proof will be reviewed before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to The Journal pertain.

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SYSTEMATIC REVIEW OF DECISION AIDS FOR NEWLY DIAGNOSED PROSTATE CANCER PATIENTS MAKING TREATMENT DECISIONS

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Prajakta Adsul, MBBS, MPH, PhD,1; Ricardo Wray, PhD,1; Kyle Spradling, BA2; Oussama Darwish, MD2; Nancy Weaver, PhD, MS1; Sameer Siddiqui, MD2

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Corresponding author: Prajakta Adsul, MBBS, MPH, PhD 3545 Lafayette Ave, Rm 329 Saint Louis, MO 63104 Tel: 314-977-3211 Fax: 314-977-6310 Email: [email protected]

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1. Department of Behavioral Science and Health Education, College for Public Health and Social Justice, Saint Louis University, Saint Louis, MO 2. Division of Urologic Surgery, School of Medicine, Saint Louis University, Saint Louis, MO

Keywords: Systematic Review; Prostate Cancer; Treatment; Shared Decision Making; Patient Decision Aids

No of illustrations: 7 No of references: 30

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Word count: 2359

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Abstract word count: 658

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Author Roles: PA contributed to the conception, design, analysis and interpretation of data. RW, NW and SS contributed to the conception and design as well as interpretation of data. OD and KS helped in the data collection, analysis and interpretation. All authors contributed to the development and revision of the manuscript. Acknowledgements: We acknowledge the authors of the decision aids that were included in this study. Funding: This work was made possible with the support of the Saint Louis University Center for Cancer Prevention, Research and Outreach with funds from Emerson, Express Scripts Foundation and Ascension Health. Running head: Patient decision aids for prostate cancer treatment

ACCEPTED MANUSCRIPT Patient decision aids for prostate cancer treatment Abstract Background Despite established evidence for using patient decision aids, their use with newly

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diagnosed prostate cancer patients remains limited, partly due to variability in the characteristics of decision aids. The objective of this study was to systematically review decision aids for their

practice for newly diagnosed prostate cancer patients.

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Methods

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content, development process, effectiveness and potential for implementation in routine urologic

Published peer-reviewed journal articles, unpublished literature on the Internet, and the Ottawa decision aids web repository were searched to identify decision aids designed for prostate cancer patients facing treatment decisions. A total of 14 decision aids were retrieved and

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included in the study. In addition, supplementary materials regarding the development of the decision aids and 4 published studies regarding the evaluation of these decisions aids were also included. Decision aids included in the study were those documents: designed to help patients

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make specific and deliberative choices among options and outcomes relevant to their health status; specific to the treatment of prostate cancer; and in English only. Decision aids were

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reviewed by 3 coders for the presence of the previously validated International Patient Decision Aid Standards (IPDAS) and additional standards deemed relevant to prostate cancer treatment decisions. Decision aids were also reviewed for novel criteria addressing their potential for implementation, including format and health literacy standards as identified through the review of current dissemination and implementation literature regarding decision aids. Acceptable interrater reliability (Krippendorff’s alpha) was achieved at 0.82.

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ACCEPTED MANUSCRIPT Patient decision aids for prostate cancer treatment Results Of the 14 decision aids retrieved, 8 (57.1%) were developed in the United States. Six (42.8%) decision aids were print based, 5 (35.7%) were web-based or both. Only 4 (28.5%)

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decision aids had been updated since 2013. Ten (71.4%) aids were targeted to a specific stage of prostate cancer (i.e. early stage, advanced, metastatic). All decision aids discussed radiation, 12 (85.7%) aids discussed surgery, 9 (64.2%) discussed active surveillance and/or watchful waiting,

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and 7 (50%) discussed hormonal therapy. When information was available, most (64.2%)

decision aids presented balanced perspectives about the benefits and risks of treatment and/or the

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outcome probabilities associated with each treatment option. Ten (71.4%) decision aids presented values clarification prompts for patients and outlined explicit steps to making treatment decisions.

Although all decision aids mentioned the developer’s credentials, none of the decision

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aids were field tested with physicians and only 4 (28.6%) were field tested with patients. Nine (64.2%) decision aids provided details about their data appraisal methods and only 4 (28.6%) decision aids commented on the quality of the evidence used in the development of the decision

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aids. Overall, only 4 (28.6%) decision aids had associated published journal articles that provided information regarding the effectiveness of decision aids when tested with patients. The

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only common outcome measure in all 4 studies was the changes in the patient’s knowledge regarding treatment options for prostate cancer. Regarding criteria addressing implementation potential, in terms of format, 5 decision

aids supplemented their print materials with audio recording or videos. Of the 8 decision aids that were web-based or computer-based, 7 (87.5%) provided patients with the opportunity to interact with the decision aids. All but 1 decision aid scored above the 9th grade reading level

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ACCEPTED MANUSCRIPT Patient decision aids for prostate cancer treatment based on the SMOG formula. No evidence regarding the implementation of decision aids in routine practice was available for decision aids. Conclusions

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None of the decision aids reviewed in this study met all the International Patient Decision Aid Standards. Content, format and presentation of prostate cancer information within the

decision aids varied substantially. Critical issues such as the risk of overtreatment and active

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surveillance were not covered in all decision aids. Aids were generally not written using plain language and very limited information was available regarding the effectiveness and

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implementation of these tools. As physicians look to adopt decision aids for their practice, they may base the choice of decision aid on characteristics that correlate well with the socioeconomic and educational status of their patient populations, their personal practice styles and their practice

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settings.

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ACCEPTED MANUSCRIPT Patient decision aids for prostate cancer treatment Manuscript text

Introduction

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Shared treatment decision making is a process of interaction between a physician and a patient in which information is exchanged about treatment options and personal preferences of the patient; the most relevant choices are deliberated; and a decision is jointly made about the

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treatment to be implemented.1 Shared decision making is considered an essential component of delivering patient centered care. Recent guidelines by the American Urological Association have

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strongly encouraged urologists to engage in shared decision making.2,3

To facilitate this process, several “patient decision aids” have been produced. These aids, defined as interventions designed to help patients in the medical encounter make treatment decisions,4 differ from conventional educational materials by presenting balanced information

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about treatment options so that patients can arrive at an informed judgment about the personal value of and preferences among those options. Decision aids can offer a structured approach for translating medical evidence, eliciting values and preferences of the patient and planning the next

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steps in decision making.5

Several patient decision aids have been developed for a number of medical conditions

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and in various formats as evidenced by the number of Cochrane reviews.6-9 The most recent Cochrane review studied a total of 115 decision aids to establish the effectiveness of decision aids used in randomized controlled trials.9 The review concluded that compared to usual care, patients who used decision aids had greater knowledge of treatment options, a stronger understanding of treatment risks, and a higher proportion of decisions that were consistent with individual values and preferences.

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ACCEPTED MANUSCRIPT Patient decision aids for prostate cancer treatment The 2014 Cochrane review included 3 decision aids geared towards prostate cancer treatment decisions.10-12 In a 2009 review by Lin and colleagues, the authors found 13 decision aids geared towards treatment decision making in prostate cancer.13 The study found that the use

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of decision aids can improve patient’s knowledge, encourage more active patient participation in decision making and decrease levels of anxiety and stress. In all the decision aids studied, there was significant variability in the characteristics and quality of the decision aids.14 The aids

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studied included those that were produced largely by a mix of not-for-profit and commercial organizations, many of which are easily available on the Internet without any published evidence

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of effectiveness.15

Since content presented within the decision aid can have an important influence on the choice made by the patient,16 the International Patient Decision Aids Standards (IPDAS) collaboration was formed in 2006 to develop a quality criteria framework for patient decision

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aids.14 Using a Delphi process, 3 subsets of quality criteria were proposed: content, development process, and effectiveness. The final checklist, available online, consists of 64 items that describe an "ideal" decision aid such as the format, content and presentation styles which may be related

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to the ways in which patients use decision aids and thereby enhance or reduce their effectiveness.17 The authors of both the reviews suggest the need to study the content within

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these decision aids and to better understand how to implement decision aids in routine practice.9,13 Hence, the purpose of the study was to assess the characteristics of patient decision aids designed for men facing prostate cancer applying the IPDAS criteria supplemented by criteria seeking to assess potential for implementation of decision aids in routine clinical practice.

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ACCEPTED MANUSCRIPT Patient decision aids for prostate cancer treatment Methods Data sources, search strategy and study selection A systematic search of published literature and online sources was conducted to identify

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and obtain patient decision aids publicly available for use by patients and physicians. A search of the academic literature used MEDLINE, Web of Science, and PsychInfo databases for articles in peer reviewed journals from database inception to January 2014. Search terms included:

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“prostatic neoplasm,” “prostate cancer,” “prostate cancer treatment,” “decision aids,” “shared decision making,” “decision support interventions,” and “treatment.” (Figure 1). Inclusion

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criteria stipulated that decision aids were designed to be used by patients facing treatment decisions; updated in the last ten years (2004-14) and were written in English. We excluded studies that described decision support interventions delivered by clinical or research staff or decisional guidance given by physicians. A total of 9 studies met the eligibility criteria, and

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referenced 6 unique decision aids included in this review.

An additional search identified decision aids without published studies. The Ottawa Health Research Institute web repository of decision aids was also crosschecked to identify

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decision aids that may have been missed (Figure 2). The primary author reviewed each study and decision aid for inclusion contacted the authors to obtain permission to request and review copies

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of the aids. An additional five aids were obtained in this way, making a total of 14 included in the review.

Data extraction, synthesis and analysis Three reviewers independently assessed each decision aid and coded for 106 variables. Items were largely derived from the International Patient Decision Aid Standards (IPDAS).14 We

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ACCEPTED MANUSCRIPT Patient decision aids for prostate cancer treatment supplemented these criteria with disease specific measures and items to assess factors that may influence the implementation of decision aids such as format, tailoring and administration of the decision aids. These criteria relate to the implementation potential of the decision aid in routine

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practice and can be considered as preceding factors affecting implementation of innovations.18 All three coders trained for coding the decision aids and an acceptable inter-rater

reliability, .82 (Krippendorff’s alpha) was achieved.19 The three coders then reviewed each

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decision aid separately and disagreements were resolved through discussions and consensus

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between all three coders.

Results Overall characteristics

Overall characteristics of the decision aids are summarized in Table 1. Seven of the 14

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decision aids were developed outside the US. Most decision aids targeted patients with a particular stage of prostate cancer, specifically the early, low-risk, localized prostate cancer. Developers of decision aids included individual researchers (35.7%); university based medical

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centers (14.3%); national health care organizations (28.6%) and for-profit institutions (21.4%).

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Content presented within decision aids Fifty-two variables assessed the content: information about prostate cancer; treatment

options for prostate cancer; procedures relevant to understanding prostate cancer treatment options; risks and benefits of each treatment option; positive and negative outcome probabilities of each treatment option; presentation of information in an unbiased way; values clarification; and decisional guidance. (Table 3)

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ACCEPTED MANUSCRIPT Patient decision aids for prostate cancer treatment Eleven (78.5%) decision aids provided information about prostate cancer and, of these, 8 (72%) described the natural course of the disease. Of the 14 aids studied, only 1 (7.1%) described the concepts of over diagnosis and overtreatment. All but 1 decision aid described the

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decision that needed to be made by the patient. Within the discussion of prostate cancer diagnosis, 9 (64.28%) decision aids described what the Gleason score meant and the corresponding stages of prostate cancer.

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Treatment options discussed included surgery (14), radiation (15), active surveillance (10), watchful waiting (10), hormonal therapy (8) and combination therapy (5). Ten decision

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(71.4%) aids described both the benefits and risks of surgery and radiation as treatment options and only 1 decision aid presented the risks of surgery and radiation without mentioning the benefits. Of the 14 decision aids studied, only 2 (14.3%) described the risks and benefits of all treatment options. Most inconsistencies in presenting outcome probabilities were noted for the

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hormonal (35.7%), watchful waiting (50%) and active surveillance (50%) treatment options. Overall, 10 (71.4%) decision aids presented outcome probabilities and 9 (64.3%) of these

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defined the group and the time period for the event rate presented.

Development process of the decision aids

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All decision aids provided the credentials of the developers on the decision aid. (Table 4)

Seven (50%) decision aids mentioned incorporating the needs of the patients and 4 (28.6%) incorporated the needs of the health professionals in developing the decision aids. Ten (71.4%) decision aids were reviewed by professional experts in the field and 7 (50%) were reviewed by prostate cancer patients during the development process. Prior to distribution of decision aids, 4 (28.6%) were field tested with patients and none were field tested with physicians or urologists.

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ACCEPTED MANUSCRIPT Patient decision aids for prostate cancer treatment Nine (64.3%) decision aids mentioned date of last update and only 5 (35.7%) reported update frequency.

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Effectiveness of the decision aids

As summarized in Table 2, only 6 (42.9%) decision aids reviewed had associated studies that described their development, effectiveness and implementation in varying details. Studies

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included were only about the decision aids and were either pilot (2 studies) or evaluation studies

for option match.

Implementation of decision aids

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(4 studies). Four studies measured improvements in knowledge of options and one study looked

Decision aids were reviewed for their format, whether they targeted the information to a

any resources for use.

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specific group, whether they followed basic health literacy principles and whether they required

We considered a decision aid to be web-based if it was available on the Internet and

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allowed for data entry and reporting of personal health information. In this review 5 (35.7%) decision aids were web-based. Of these, 4 (28.6%) allowed patients to search using key words

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and 4 provided a report of the personal health information entered by the patient. All 5 webbased decision aids allowed for navigation by providing a step-by-step guide for moving through the website, allowed patients to return to the decision aid after visiting external reference websites and permitted printing the decision aid as a single document. Seven (50%) decision aids were available in print format only. Of the 7 decision aids available in print, 5 decision aids provided a space for patients to take notes and 4 decision aids were more than 10 pages in length.

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ACCEPTED MANUSCRIPT Patient decision aids for prostate cancer treatment Two decision aids were computer-based, and had to be downloaded and installed onto a personal computer for use. All 7 decision aids that were computer or web-based were considered to be interactive in that they encouraged user input. Four (28.6%) decision aids used audio and videos

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methods to present information.

Four (28.6%) decision aids were customized to treatment type such as active surveillance or radiation therapy; 2 (14.3%) were targeted to a specific population; and 10 (71.4%) were

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specific to the stage of prostate cancer (6). Two (14.3%) decision aids provided individualized information and allowed patients to view outcome probabilities based on their own situation and

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2 other decision aids discussed associated co-morbidities that could influence the patient's treatment decisions. Thirteen (92.9%) decision aids clearly described the goals and objectives of the decision aid and 8 (57.1%) directed patients to external resources such as books to read and support groups. None of the decision aids mentioned any references to existing shared decision

Discussion

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making frameworks.

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Urologists and their patients are increasingly encouraged to participate in shared decision making for prostate cancer related medical decisions.2 Decision aids can help to increase patients'

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knowledge about treatment options and engage them in shared decision making.9 This study illustrates that no existing patient decision aids for prostate cancer treatment meet all internationally agreed upon criteria for quality of patient decision aids. Furthermore, this review shows that although patient decision aids provide extensive information, they lack several important characteristics in terms of their development and evaluation.

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ACCEPTED MANUSCRIPT Patient decision aids for prostate cancer treatment Very few decision aids present a thorough description of risks and benefits and outcome probabilities, which are essential elements of decision aids.20,21 Given the paucity of comparative

quality evidence in order to present outcome probabilities.22

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effectiveness research for treatment options decision aid developers may not have access to high

Recent evidence gathered from prostate cancer patients has highlighted the importance of spouses in treatment decision making.23 However, only half of the decision aids encourage

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patients to share the decision aid with their spouse while only 14.3% include spouses in the

development process. Most decision aids are intended to be used during the clinical encounter,24

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thus it is important that urologists not only be involved in the development process but also field test the decision aids in order to improve uptake and dissemination which was lacking according to this review.

Decision aids that look comprehensive in this review may actually not be adopted

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because they are too long and are written in language that is too complex. When looking for health literacy assessments, it is important to look beyond only readability level testing. Context, style and presentation, format and organization of the text contribute to the ability of readers to

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understand written text.17 All these criteria need to be explicitly evaluated before patient decision aids can be adopted by urologists and their patients. Furthermore, the need remains to conduct

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additional evaluation studies with robust and consistent measures to develop an evidence base for the use of patient decision aids among prostate cancer patients facing treatment decisions.25 The study reviewed the decision aids that were accessible on the internet and those that

the authors were able to obtain. Hence, data reported in this systematic review may not reflect unpublished decision aids that are obtained by urologists through informal sharing. The focus of this review was to highlight the decision aids that were publicly available and could be easily

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ACCEPTED MANUSCRIPT Patient decision aids for prostate cancer treatment accessed by patients and urologists. For this purpose, we used a systematic search strategy, a measurement strategy with internationally accepted standards and rigorous coding benchmarks. Despite the study rigor, it must be acknowledged that these data do not provide evidence on

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extent of use of these aids by patients and physicians and their effects on treatment decisions and related outcomes.

In summary, none of the decision aids met all the recently promulgated international

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criteria. This study was one of few studies to apply the IPDAS criteria to date and assess its applicability in researching patient decision aids, especially in the context of prostate cancer

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treatment decision making. Previous studies have studied the content within the decision aids before the launch of the IPDAS criteria13,26 but have not reviewed the content within the decision aids after the launch of the IPDAS in 2006.14 This study also provides a first step in assessing implementation by presenting a detailed review of the formats of available decision aids as a

Conclusion

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whole.

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This review provides insight into the variability among existing patient decision aids for prostate cancer treatment. Urologist recommendations have been the most important factor

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influencing patient's decisions.17 Understanding patient preferences is a critical component of SDM however, and may be enhanced with the routine use of decision aids. Further research is required to assess physician perceptions towards the variables reviewed in this study in order to determine whether they will be adopted and implemented in routine practice, and whether they will improve patient outcomes. It is critical that developers test the feasibility of decision aids with users, including both patients and physicians themselves.

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O'Connor A. Using patient decision aids to promote evidence-based decision making. ACP journal club. Jul-Aug 2001;135(1):A11-12. O'Connor AM, Drake ER, Fiset V, Graham ID, Laupacis A, Tugwell P. The Ottawa patient decision aids. Effective clinical practice : ECP. Jul-Aug 1999;2(4):163-170. Wilt TJ, MacDonald R, Rutks I, Shamliyan TA, Taylor BC, Kane RL. Systematic review: comparative effectiveness and harms of treatments for clinically localized prostate cancer. Annals of internal medicine. Mar 18 2008;148(6):435-448. Davison BJ, Breckon E. Factors influencing treatment decision making and information preferences of prostate cancer patients on active surveillance. Patient education and counseling. 2012;87(3):369-374. Stacey D, Samant R, Bennett C. Decision Making in Oncology: A Review of Patient Decision Aids to Support Patient Participation. CA: a cancer journal for clinicians. 2008;58(5):293-304. Cooperberg MR, Broering JM, Carroll PR. Time Trends and Local Variation in Primary Treatment of Localized Prostate Cancer. Journal of Clinical Oncology. March 1, 2010 2010;28(7):1117-1123. Fagerlin A, Rovner D, Stableford S, Jentoft C, Wei JT, Holmes-Rovner M. Patient education materials about the treatment of early-stage prostate cancer: a critical review. Annals of internal medicine. May 4 2004;140(9):721-728.

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Target audience

Organization

Country

Evaluation

1

Knowing Your Options: A decision aid for men with clinically localized prostate cancer

Clinically localized prostate cancer

Agency for Healthcare Research and Quality

US

No

2

Your Options for Low-Risk Prostate Cancer

Low risk prostate cancer

Institute for Clinical and Economic Review

US

No

3

Making the Choice Deciding what to do about Early Stage Prostate Cancer

Early stage

Michigan Cancer Coalition

US

Yes

4

Prostate Cancer: Should I Choose Active Surveillance?

Localized prostate cancer

Health wise

US

No

5

Prostate cancer: Should I have radiation or surgery for localized prostate cancer?

Localized prostate cancer

Health wise

US

No

6

Choice between prostatectomy and radiotherapy

Prostate cancer patients eligible for both

van Tol-Geerdink

NET

Yes

7

Choosing the radiation dose in the treatment of prostate cancer

Prostate cancer patients eligible for radiation

van Tol-Geerdink

NET

Yes

8

Treatment of Early Stage Prostate Cancer

Intermediaterisk, early-stage prostate cancer, Canadian men

Feldman-Stewart, Queens University

CAN

No

9

Treatment Choices for Men with Early-Stage Prostate Cancer

Early stage

National Cancer Institute

US

No

10

Prostate Interactive Education System

Early stage

Temple University

US

Yes

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Option Grid - Localized prostate cancer-low risk

Localized prostate cancer, low-risk, UK, US, Spanish

Option Grid (Authors: Jelski, J., Burns-Cox, N., Collins, A., et.al.)

UK

No

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Prostate Cancer - A guide for men who have just been diagnosed

Just diagnosed

Prostate Cancer UK

UK

No

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Name of the decision aid

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Target audience

Organization

Country

Evaluation

13

Multimedia Program for Prostate Cancer

Prostate Cancer patients

van Schaik, Tees University

UK

Yes

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Treatment choices for localized prostate cancer

Localized prostate cancer

Health Dialog, Foundation for Informed Medical Decision Making

US

No

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Name of the decision aid

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*Web-based decision aid is one which is housed on the World Wide Web and allows for data entry and reporting of the personal health information; Digital decision aids are essentially print documents that can be shared via the web but do not allow for data entry or reporting of the personal health information; Computer based are decision aids that are downloaded to the computer and do not require Internet connection;*Print based decision aids are aids that are available in a pdf format which be downloaded and printed for use.

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Table 2. Studies included in the systematic review Citation

Methods

Population studied

Results

DA 3

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Formative evaluation included focus groups (n=4) and survey of men newly diagnosed with prostate cancer (n=60), compared with historical controls (n=184)

60 men newly diagnosed with prostate cancer for the survey

(i) DA was clear and useful in reaching a decision (ii) patients reported more discussions with doctors about treatment options (iii) increase in knowledge of side effects of radiation therapy

DA 6

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Randomized controlled trial, patients were randomized to a group which only discussed their treatment with their specialist (usual care group) and a group which received additional information and a decision aid presented by a researcher (decision aid group)

240 patients with localized prostate cancer from 3 separate hospitals in the Netherlands

(i) treatment choice was affect by the DA and by the hospital of intake (ii) DA led to more patient choosing brachytherapy fewer patient remaining undecided (iii) prostatectomy remained more frequently preferred treatment (iv) age, tumor characteristics or pretreatment urinary, bowel or erectile functioning did not affect the choice in this selected group (iv) Patients choosing brachytherapy assigned more weight to convenience of the procedure and to maintaining erectile function.

DA 7

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Pre post intervention study of patient presented by 2 treatment options : radiotherapy with 70 Gy versus 74 Gy.

150 patients with primary prostate cancer (T1-3N0M0)

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DA

(i) Majority of the patient chose the lower radiation dose (ii) choice was highly consistent with the importance of weights assigned to the probability of survival, cure and late gastrointestinal and genitourinary adverse effects (iii) lower does was chosen more often by older patients, low-risk patients, patients without hormone treatment, and patients with a low anxiety or depression score.

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Table 2. Continued DA

Citation

Methods

Population studied

Results

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Formative interviews with surrogate patients

Men never diagnosed with prostate cancer, at least 50 years old

Information presentation, with comprehension questions: mean of 94.7% correct without a prompt, (ii) Exercises to help identify attributes important to the decision: median of 5 attributes as important (ranges 1-14) at each of 3 points during the interview, and (iii) Values-clarification exercises: Participants showed a wide range of values in each of 7 trade-off exercises. Testing with actual patients of prostate cancer is ongoing.

DA10

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Randomized control trial with 3 experimental conditions (1) control condition (providing information through standard National Cancer Institute brochures; 26%), and PIES (2) with tailoring (43%) and (3) without tailoring to a patient’s information-seeking style (31%).

72 patients with newly diagnosed localized prostate cancer who had not made a treatment decisions

The PIES program was well accepted by patients and did not interfere with the clinical routine. About 79% of eligible patients (72/91) completed the pre- and post-PIES intervention assessments. Patients in the PIES groups compared with those in the control condition were significantly more likely to report higher levels of confidence in their treatment choices, higher levels of helpfulness of the information they received in making a treatment decision, and that the information they received was emotionally reassuring. Patients in the PIES groups compared with those in the control condition were significantly less likely to need more information about treatment options, were less anxious about their treatment choices, and thought the information they received was clear (P < .05). Tailoring PIES information to information-seeking style was not related to decision-making variables.

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Table 2. Continued

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A within-subjects design was used to investigate the changes in levels of cancerrelated knowledge, psychosocial functioning, treatment decision-making role and information needs immediately after browsing the MMP

Population studied 67 men recently diagnosed with prostate cancer

Results After browsing the MMP significant increases in knowledge and reductions in distress were reported. Marital status was significantly associated with knowledge gain. Married men and those attending the study session with their spouse displayed a significant shift towards a more active role in treatment decisions. The majority of information needs were fulfilled by the MMP; however, information related to the likelihood of a cure, treatment side effects, coping strategies and etiology were not completely satisfied by the MMP.

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Table 3 Content presented within the decision aids

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Share with others

Tools to talk to providers

Steps to decision†

Uncertainty† Physical effects† Psychological effects† Social effects† Ma3ers most†

Event rate balanced† Mul!ple methods† Equal details† Compare op!ons†

Event rate†

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+ve out- Surgery† +ve out- Radia!on† +ve out - Hormonal† +ve out - WW† +ve out - AS† -ve out - Surgery† -ve out - Radia!on† -ve out - Hormonal† -ve out - WW† -ve out – AS† Defined group† Defined !me period†

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Option- Surgery† Option- Radia!on† Option- Hormonal† Option- WW† Option- AS† Option - Combina!on†

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Benefits and risks of treatment

Proc- Prostatectomy Benefits- Surgery† Benefits - Radia!on† Benefits - Hormonal† Benefits - WW† Benefits - AS† Risks - Surgery† Risks - Radia!on† Risks - Hormonal† Risks - WW†

Procedure described

Treatment options

PCa stages

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Describe decision†

Over-diagnosis /Rx

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Prostate Cancer (PCa)†

Prostate cancer information

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*Other treatment options included: High intensity focus ultrasound, proton beam therapy, robotic, external beam, cryotherapy, CAM, orchidectomy, chemotherapy, palliative care, pain reliving drugs, palliative endoscopy, biphosphonates, and expectant management † indicates criterion included from the International Patient Decision Aid Standards

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Freely available Requires computers Requires Internet Needs staff assistance Self-administered

Tailoring

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Reading and more

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Developer credentials Needs of paents† Needs of providers† Expert review- paents† Expert review- prof† Field tesng with pts† Field tested with phy† References† Data appraisal† Last update† Update freq† Quality of evidence† Funding† COI† Dev- Patients Dev- F/F/Caregivers Dev-Experts Evaluation studies Decisional quality Knowledge of opons† Clarity on outcomes Discuss values Opon match† Format- Web based Web-navigation Web- search Web-feedback Web-return Web- print Format- Print Print- Note taking Print – >10 pgs Format- Computer Format- Interactive Format- Audio Format- Video Stories, anecdotes Stories-range Stories-incentives Stories-consent Tailored-Rx Tailored-Population Tailored-risk factors Tailored-PCa Stage Individualized Co-morbidities Goals and objectives Other resources SDM framework th SMOG score < 9 grad†

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Table.4. Development process, effectiveness and implementation characteristics of decision aids

Resources

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Figure.1. Search methods for published studies

No. of studies in manual searches: 12

No. of studies after removing duplicates: 229

Excluded studies: 186

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No. of studies screened for relevance: 229

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No. of studies in published literature: 310

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No. of studies assessed for eligibility: 43

No. of studies identified: 9

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No. of decision aids identified: 6

Excluded studies: 38

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Figure 2. Search process for decision aids

No. of decision aids identified through Google: 10

No. of decision aids identified through OHRI*: 8

Total decision aids retrieved: 24

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No. of decision aids identified through published literature: 6

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Duplicates removed: 7 Total decision eligible: 17

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No correspondence from authors: 3

Total decision aids included: 14

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*OHRI: Ottawa Health Research Institute

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PCa – Prostate Cancer DA – Decision Aids SDM – Shared Decision Making IPDAS –International Patient Decision Aids Standards

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AUA – American Urological Association

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ACS – American Cancer Society

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APPENDIX A. SYSTEMATIC REVIEW CODES AND THEIR DESCRIPTIONS

Descriptions This domain tests whether the decision aid provides information about the options in sufficient detail for making a specific decision.

1. Prostate Cancer

The decision aid provides a description about prostate cancer including but not limited to the anatomy of the prostate gland, epidemiology, pathology, signs and symptoms.

2. Natural course

The decision aid describes the natural course of prostate cancer without treatment. For e.g. “Prostate cancers that do go beyond the prostate cancer spread to the pelvis or back bone and can cause pain and other symptoms. Even so, most men with prostate cancer will not die from it, even without treatment.”

3. Over diagnosis and over treatment

The decision aid mentions and explains over treatment or over diagnosis. For example, it mentions the factors that may lead to over diagnosis such as a large, silent reservoir of prostate cancer, widespread screening with PSA, and indolent natural history of prostate cancer. Over diagnosis may result in over treatment, which in the case of prostate cancer often carries significant, long term quality-of life effects. The decision aid may describe either or overdiagnosis and over treatment.

4. Describe decision

Does the decision aid describe the decision that needs to be made? The decision aid should explicitly state what decision is being made. For e.g. a decision aid states “The decision for treatment is up to you. Different people make different choices” or “It’s not always easy to choose the best treatment. Even doctors don’t always agree

Gleason score

The decision aid provides an explanation about the GLEASON SCORE and what the scores mean. Sometimes, the decision aid may not explain the procedure associated with it or how it is derived (biopsy, pathology reporting, etc) but at least talks about the implications of having a particular score.

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Codes Prostate Cancer Information

5. Prostate Cancer stages

Does the decision aid describe the stage classification for prostate cancer? Various staging systems are used, however, the most common one used is the TNM staging where T is the local extent of the Tumor within the prostate gland, N indicates whether the cancer has spread to nearby regional lymph Nodes, and M describes whether the cancer has spread to distant parts of the body i.e. Metastasis. Based on these characteristics the stages may be Stage I, IIA, IIB, III, and IV.

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Codes Descriptions Treatment Options This domain looks for descriptions of treatment options for prostate cancer 6. Option- Surgery Does the decision aid list and explain SURGERY as a treatment option? Does the decision aid list and explain RADIATION as a treatment option?

8. Option- Hormonal therapy

Does the decision aid list and explain HORMONAL THERAPY as a treatment option?

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Does the decision aid list and explain WATCHFUL WAITING as a treatment option? Watchful waiting or expectant management is reserved for older men with limited life expectancy. As evidence of disease progression emerges, hormonal therapy is offered rather than aggressive treatment options. This strategy is based on the concept that the natural history of Prostate cancer is often prolonged and older patients with a less than 10 year life expectancy will not benefit and may in fact be harmed by radical treatment.

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7. Option- Radiation therapy

Does the decision aid list and explain ACTIVE SURVEILLANCE as a treatment option? Active surveillance allows for men with low risk prostate cancer to defer therapy and thus delay its resulting complications until therapy becomes absolutely essential for survival. Compared to watchful waiting, men undergoing active surveillance are followed more vigorously for any evidence of disease progression so they can be treated within the window of curability.

10. Option Combination

Does the decision aids describe and list the options of COMBINING any of the above mentioned treatments? For e.g. patients may be advised that “sometimes doctors might advise you to combine therapies to achieve the best results in your particular case”

EP

Does the decision aid list and explain ANY OTHER treatment option? Other treatment options may include but not be limited to: High intensity focus ultrasound, proton beam therapy, robotic, external beam, cryotherapy, CAM, orchidectomy, chemotherapy, palliative care, pain reliving drugs, palliative endoscopy, biphosphonates, and expectant management

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11. Option- Other

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9. Option- Active Surveillance

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Descriptions This domain indicates whether a decision aid did or did not describe the relevant procedures in order to understand the prostate cancer diagnosis and treatment options. PSA test and the DRE were included in this domain because these tests may be used to monitor therapy success and therefore can be important for the patient to understand . Does the decision aid mention and explain the procedure for the Prostate Specific Antigen Test?

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Codes Procedures described

Proc- PSA test

13.

Proc- DRE

Does the decision aid mention and explain the procedure for the Digital Rectal Exam?

14.

Proc- Biopsy

Does the decision aid mention and explain the procedure for the PROSTATE BIOPSY? Sometimes the scorings system may be explained in conjunction with an explanation for prostate biopsy.

15.

Procedure Prostatectomy

Does the decision aid mention and explain the procedure for the PROSTATECTOMY? Prostatectomy is surgery that is performed to remove all of the prostate gland and some of the tissue around to effectively treat prostate cancer. Four main types of these procedures exist: manual (depending on the incision site it could be either retropubic or perineal), laparoscopic or robot-assisted. Important to note: Robotic prostatectomy may be described under “newer” treatments but should be considered as a surgical therapy for prostate cancer This domain presents the benefits and risks associated with each of the treatment options. Benefits and risks of each of the procedures are different from outcome probabilities in that they represent over benefits of getting a particular treatment over the other and do not necessarily associate a value (percentage, no of days in hospital, no of cases, etc.) with the outcome.

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BenefitsSurgery

Does the decision aid provide a description about the BENEFITS of SURGERY? For example, the decision aid may describe the benefit of surgery being that all or most of the cancerous tissue can be removed if the cancer is in its early stages.

17.

Benefits Radiation

Does the decision aid provide a description about the BENEFITS of RADIATION? For example, the decision aid may describe that one of the benefits of radiation is that a hospital admission may not be required when compared to surgical therapies.

18.

Benefits Hormonal

Does the decision aid provide a description about the BENEFITS of HORMONAL? For example, the decision aid might mention – for men whose prostate cancer has spread and is causing pain, hormone therapy has been shown to reduce pain and help them live longer.

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Codes Benefits - WW

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Benefits - AS

Does the decision aid provide a description about the BENEFITS of ACTIVE SURVEILLANCE? For example, the decision aid might mention – men opting for watchful waiting or active surveillance will avoid dealing with the side effects of treatment. Sometimes the discussion of benefits might be combined for active surveillance and watchful waiting.

21.

Risks - Surgery

Does the decision aid provide a description about the RISKS of SURGERY? Risks of surgery include death, heart attacks, stroke, damage to rectum, urine leakage, etc. Please note: There is a difference between a discussion of risks and outcome probabilities ( where the rates of event occurrences are described i.e. 1 out of 1000 men below 65 years undergoing prostatectomy will die due to surgery)

22.

Risks - Radiation Does the decision aid provide a description about the RISKS of RADIATION? Possible risks of radiation therapy may include developing urinary dysfunction, cancer of the rectum, etc.

23.

Risks Hormonal

Does the decision aid provide a description about the RISKS of HORMONAL? Possible risks of hormonal therapy include sexual problems, weakened muscles, and bones.

24.

Risks - WW

Does the decision aid provide a description about the RISKS of WATCHFULWAITING? Possible risks of WW/AS include a cancer that has not spread may spread to other parts of the body.

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Risks - AS

Does the decision aid provide a description about the RISKS of ACTIVE SURVEILLANCE? Sometimes the discussion of risks might be combined for active surveillance and watchful waiting.

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This domain presents the outcome probabilities from each of the treatment options and is associated with a specific value (percentage, no of days in hospital, no of cases, etc.) with the outcome.

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Outcome Probabilities

Descriptions Does the decision aid provide a description about the BENEFITS of WATCHFULWAITING? For example, the decision aid might mention – men opting for watchful waiting or active surveillance will avoid dealing with the side effects of treatment.

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+ve out- Surgery

Does the decision aid provide a description about the POSITIVE OUTCOME PROBABILITIES of SURGERY? Please note: There is a difference between a discussion of risks and outcome probabilities ( where the rates of event occurrences are described i.e. 1 out of 1000 men below 65 years undergoing prostatectomy will die due to surgery)

27.

+ve outRadiation

Does the decision aid provide a description about the POSITIVE OUTCOME PROBABILITIES of RADIATION?

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28.

Codes +ve out Hormonal

Descriptions Does the decision aid provide a description about the POSITIVE OUTCOME PROBABILITIES of HORMONAL?

+ve out - WW

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+ve out - AS

31.

-ve out Surgery

Does the decision aid provide a description about the NEGATIVE OUTCOME PROBABILITIES of SURGERY?

32.

-ve out Radiation

Does the decision aid provide a description about the NEGATIVE OUTCOME PROBABILITIES of RADIATION?

33.

-ve out Hormonal

Does the decision aid provide a description about the NEGATIVE OUTCOME PROBABILITIES of HORMONAL?

34.

-ve out - WW

Does the decision aid provide a description about the NEGATIVE OUTCOME PROBABILITIES of WATCHFULWAITING?

-ve out – AS

Does the decision aid provide a description about the NEGATIVE OUTCOME PROBABILITIES of ACTIVE SURVEILLANCE?

35.

Defined group

Does the decision aid specify the defined group (reference class) of patients for which the outcome probabilities apply? For example, the outcome probabilities maybe derived from a study of Scandinavian men and those should be mentioned as the reference class here.

36.

Defined time period

Does the decision aid specify the time period over which the outcome probabilities apply? For example, the decision aid might state that the study observed the patient of active surveillance for only 10 years post their decision. Hence, outcomes were assessed at the 10 year completion period and not over the lifetime.

37.

Event rates

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Does the decision aid specify the event rates for the outcome probabilities (in natural frequencies)? For example, 1 out of 1000 men below 65 years of age undergoing prostatectomy will die due to surgery.

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Does the decision aid provide a description about the POSITIVE OUTCOME PROBABILITIES of WATCHFULWAITING? Does the decision aid provide a description about the POSITIVE OUTCOME PROBABILITIES of ACTIVE SURVEILLANCE?

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Unbiased information

This section describes characteristics of decision aids that allow for presentation of unbiased information.

Event rate balanced

Does the patient decision aid use event rates for negative and positive outcomes specifying the population and time period? The decision support technology provides balanced information about event or outcome probabilities to limit framing bias.

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Codes Multiple methods

Descriptions Does the patient decision aid use multiple methods to view probabilities (numerical, frequencies, percent, graphic pie charts, 110 people boxes, qualitative (low, moderate, high))? Please indicate yes if two or more methods are used.

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Equal details

Does the patient decision aid show negative/ positive features with equal detail (fonts, order, and display of statistics)? For example the decision aid must not display negative events in a smaller font compared to positive events in a larger font.

41.

Compare options

Does the patient decision aid allow comparison of positive and negative features of options? Typically a side by side comparison of treatment options and the benefits and risk of each of those options is presented.

42.

Uncertainty

Does the patient decision aid describe uncertainty around probabilities? At places where exact event rates are not available, the decision aid should acknowledge either the lack of data, or uncertainty surrounding the available data making it difficult to quote exact event rates

43.

Values Clarification Physical effects

This section describes the characteristics of the decision aid that may help patients clarify their personal values. Does the patient decision aid describe procedures and outcomes to help patients what it is like to experience the PHYSICAL EFFECTS? Physical effects may include problems with urination, sexual dysfunction, etc.

44.

Psychological effects

Does the patient decision aid describe procedures and outcomes to help patients what it is like to experience the PSYCHOLOGICAL EFFECTS? Emotional effects may include the emotional effects sexual dysfunction can have on their intimate relationships with their partners, or may include a discussion on living with uncertainty. Example excerpt “Hearing that you have prostate cancer may shock or frighten you, your family, and your friends. These feelings are natural.”

45.

Social effects

46.

Matters most

Does the patient decision aid ask patients to consider which positive and negative features matter most? An example excerpt “There is no right or wrong treatment choice. What matters is that you understand the possible benefits and harms and that you work with your doctor to make the choice that’s best for you.

Decision guidance

This set of criteria indicate whether the decision aid provides structured guidance in deliberation and communication

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Does the patient decision aid describe procedures and outcomes to help patients what it is like to experience the SOCIAL EFFECTS? Social effects may include, taking time away from work for surgery or a man undergoing radiation therapy may feel weak and tired to carry out social activities.

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Tools to talk to providers

49.

Share with others

50.

Does the patient decision aid suggest ways to talk about the decision with health professionals? For example a decision aid may provide a sheet in the decision aid for the patients to write down questions they may have for their doctors. Does the patient decision aid encourage patients to share information with loved ones or have discussion about their choices with other family member s or friends? This may also include discussions about bringing loved ones with them to doctor’s appointments so they can ask question and or take notes. This section describes the characteristics of the development of the decision aid. Does the patient decision aid include the developer’s credentials / qualifications?

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48.

Descriptions Does the patient decision aid provide steps to make a decision? The decision aid may describes some of the next steps that patients must think of as they make their decision such as talk to other doctors, share with friends and family, access support groups etc.

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Codes Steps to decision

Development Process Developer credentials

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Needs of patients

Does the patient decision mention the needs of users (patients and practitioners) to discuss the medical decision? For example, the decision aid mentions that it was designed to address the needs of patients (provide information to them) and to help them participate in a decision with their providers.

52.

Needs of providers

53.

Expert review patients

Does the patient decision mention the needs of users (providers) to discuss the medical decision? For example, the decision aid mentions that it was designed to address the needs of professional to help patient participate in the decisions Does the patient decision mention an expert review by patient experts not involved in the development process of the decision aids? Expert review may be considered as peer review as well.

54.

Expert review physicians

55.

Field testing patients

Has the patient decision aid been field tested with users (patients facing the decision)? Expert review/ peer review or evaluation studies do not count as field testing. Field testing may also be called pilot testing.

56.

Field testing physicians

Has the patient decision aid been field tested with users - physicians? Expert review/ peer review or evaluation studies do not count as field testing. Field testing may also be called pilot testing.

57.

References

Does the patient decision aid provide references to evidence used? Citations should be related to the studies selected to present probabilities.

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Does the patient decision mention an expert review by professional experts not involved in the development process of the decision aids? Expert review may be considered as peer review as well.

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Codes Data appraisal

Descriptions Do the patient decision aid report steps to find, appraise, and summarize evidence? In other words how was the research evidence selected or synthesized. This information could be in the associated files with the decision aid.

59.

Last update

60.

Update freq

Does the patient decision aid report date of last update or acknowledge out datedness? Does the patient decision aid report how often patient decision aid is updated?

61.

Quality of evidence

Does the patient decision aid describe quality of scientific evidence (including lack of evidence)? The decision aid should describe characteristics of the study from which evidence is quoted- for example, if the decision aid mentions a particular event rate, it should also mention what study they got their rate form and why they thought this study was more representative of the population being described. An example excerpt “A good study of Scandinavian men compared watchful waiting with radical prostatectomy. Although this study was well done, it is difficult to know how its findings apply to men in the U.S.”

62.

Funding

Does the patient decision aid report source of funding to develop and distribute the patient decision aid?

63.

COI

Conflicts of Interest. Does the patient decision aid report whether authors or their affiliations stand to gain or lose by choices patients make after using the decision aid?

64.

Dev- Patients

For the development of the decision aid, does the decision aid or the associated studies mention the - Involvement of patients?

65.

Dev- Family friends and Caregivers

For the development of the decision aid, does the decision aid or the associated studies mention the - Involvement of stakeholders such as family/friends/ caregivers?

66.

Dev-Experts

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AC C

For the development of the decision aid, does the decision aid or the associated studies mention the - Expert review by physicians and researcher in the field?

67.

Effectiveness

This section describes characteristics of the decision aid that are evaluated in the decision aid to determine its effectiveness in patients. These outcomes should be derived from associated studies of the patient decision aids.

Evaluation studies

For the development of the decision aid, does the decision aid or the associated studies mention the - Evaluation studies using randomized trial designs?

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68.

Codes Decisional quality

Descriptions Does the patient decision aid help patients make a high quality decision?

Knowledge of options

Does the patient decision aid help patient know options and their features?

70.

Clarity on outcomes

Does the patient decision aid help patients be clear about the option features that matter most?

71.

Discuss values

Does the patient decision aid help patients discuss values with their practitioner?

72.

Option match

Is there evidence that the decision support technology improves the match between the features that matter most to the informed patient and the option that is chosen?

Format

Describes the characteristics of the decision aids as they relate to the format of the decision aid.

73.

Format-Web based

Is the patient decision aid web based?

74.

Web-navigation

Does the patient decision aid provide a step by step way to move through the web pages?

75.

Web- search

Does the patient decision aid allow for patient to search for key words?

76.

Web-feedback

Does the patient decision aid provide feedback on personal health information entered into the decision aid?

77.

Web-return

Does the patient decision aid make it easy for patients tor return to the decision aid after linking to other web pages?

78.

Web- print

79.

Format- Print

Print-based decision aids include pamphlets, pdfs, brochure, booklet, flipcharts, etc

80.

Print – Note taking Print - >10pgs

Does the decision aid include or provide space for note taking?

FormatComputer

Computer based decision aids come in the format of a program/software that can be downloaded to your PC and do not require internet connection.

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AC C

Does the patient decision aid permit printing as a single document? This also includes websites that may not allow to print the entire decision aid but allows to print certain sections of the decision aid

Is the decision more than 10 pages in print?

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Codes FormatInteractive

Descriptions Is the digital decision aid interactive and allow for social media plugs or does it provide feedback depending on the input of the user? For example, a website might show individualized probabilities depending upon the PSA level, Gleason score and the staging of the prostate cancer for that patient.

RI PT

83.

Format- Audio

Does the decision aid use audio clips without any video?

85.

Format- Video

Does the decision aid use videos to exemplify certain sections of the patient decision aid? Videos may include patient testimonials, animations, surgical procedures, etc.

86.

Stories, anecdotes

Are stories, personal quotes or anecdotes used in the patient decision aid?

87.

Stories-range

Does the patient decision aid use stories that represent a range of positive and negative patient experiences?

88.

Storiesincentives

Does the patient decision aid report if there was a financial or other reason why patient decided to share their story?

89.

Stories-consent

Does the patient decision aid state in an accessible document that the patient gave informed consent to use their stories?

Tailoring

This section provides information about the decision aid in terms of tailoring the decision aid towards a specific target audience.

90.

Tailored-Rx

Is the patient decision aid tailored to any of the following? Type of treatment (e.g. types of surgery, types of radiation)

91.

TailoredPopulation

Is the patient decision aid tailored to any of the following? Specific populations (e.g. African American , Hispanic, etc.)

92.

Tailored-risk factors

93.

Tailored-PCa Stage

94.

Individualized

EP

TE D

M AN U

SC

84.

Is the patient decision aid tailored to any of the following? Specific risk factors (e.g. age, family history, etc.)

AC C

Is the patient decision aid tailored to any of the following? Specific stage of prostate cancer (e.g. early stage, advanced stage, etc.) Does the patient decision aid allow the patient to view probabilities based on their own situation? Please indicate "Yes" if the decision aid gives patient individualized information based on their age, race etc.

ACCEPTED MANUSCRIPT

95.

Descriptions Does the patient decision aid place probabilities in context of other comorbidities? For example, a patient decision aid might describe the risk of death during surgery may be higher for patients with hypertension (a co-morbidity).

98.

SDM framework

Does the patient decision aid / study mention the decision making framework used?

Health Literacy

The following set of criteria test the decision aid characteristics for health literacy principles. Is the patient decision aid written at a grade 9 equivalent level or less according to the SMOG readability score? This determines whether the patient decision aid written at a level that can be understood by the majority of patients in the target group.

SMOG score < 9 grade

Does the patient decision aid provide information to patients about other resources such as books to read, support groups, etc?

SC

99.

RI PT

Are the goals and objectives of the patient decision aid stated explicitly?

97.

Goals and objective Other resources

M AN U

96.

Codes Co-morbidities

Does the patient decision aids provide ways to help patient understand information other that reading (audio, animations, pictures, video, inperson discussion)?

101. Visual diagrams

Does the patient decision aid use visual diagram to demonstrate probabilities? These diagrams are limited to probabilities and could be pie charts or people boxes. Do not include diagrams of procedures or patient videos in this category.

Resources

Is the decision aid is purely computer based?

AC C

103. Requires computer

This section describes the resources that are required for the successful implementation of the decision aids. Is the patient decision aid freely available to patients on the web? Please indicate no if a monetary cost is associated with the decision aid or if it needs to be prescribed by a certain healthcare system and physicians.

EP

102. Freely available

TE D

100. Reading and more

104. Requires internet

Does the decision aid require access to the internet for its use?

105. Staff assistance

Does the patient decision aid require staff assistance?

106. Selfadministered

Is the patient decision aid self-administered?