International Patient Decision Aid Standards Research Articles

What Works in Implementing Patient Decision Aids in Routine Clinical Settings? A Rapid Realist Review and Update from the International Patient Decision Aid Standards Collaboration.

BackgroundDecades of effectiveness research has established the benefits of using patient decision aids (PtDAs), yet broad clinical implementation has not yet occurred. Evidence to date is mainly derived from highly controlled settings; if clinicians and health care organizations are expected to embed PtDAs as a means to support person-centered care, we need to better understand what this might look like outside of a research setting.AimThis review was conducted in response to the IPDAS Collaboration’s evidence update process, which informs their published standards for PtDA quality and effectiveness. The aim was to develop context-specific program theories that explain why and how PtDAs are successfully implemented in routine healthcare settings.MethodsRapid realist review methodology was used to identify articles that could contribute to theory development. We engaged key experts and stakeholders to identify key sources; this was supplemented by electronic database (Medline and CINAHL), gray literature, and forward/backward search strategies. Initial theories were refined to develop realist context-mechanism-outcome configurations, and these were mapped to the Consolidated Framework for Implementation Research.ResultsWe developed 8 refined theories, using data from 23 implementation studies (29 articles), to describe the mechanisms by which PtDAs become successfully implemented into routine clinical settings. Recommended implementation strategies derived from the program theory include 1) co-production of PtDA content and processes (or local adaptation), 2) training the entire team, 3) preparing and prompting patients to engage, 4) senior-level buy-in, and 5) measuring to improve.ConclusionsWe recommend key strategies that organizations and individuals intending to embed PtDAs routinely can use as a practical guide. Further work is needed to understand the importance of context in the success of different implementation studies.

An Autonomy-Supportive Online Decision Aid to Assist Smokers in Choosing Evidence-Based Cessation Assistance: Development Process and Protocol of a Randomized Controlled Trial.

BackgroundDecision aids (DAs) may be used to facilitate an autonomous, informed decision to cease smoking and promote the uptake of evidence-based cessation assistance (ie, behavioral support, nicotine replacement therapy, or prescription medication). However, knowledge is lacking regarding their effective elements and (cost-)effectiveness.ObjectiveWe describe the development process of an online DA (called “VISOR”) that helps smokers to choose evidence-based cessation assistance. Additionally, we provide a description of the protocol of an ongoing randomized controlled trial in which the DA containing an explicit value clarification method (VCM) and tailored advice is compared with a DA without an explicit VCM and tailored advice.MethodsThe development of “VISOR” was based on the International Patient Decision Aid Standards guidelines. Viewpoints of end users (collected through 20 interviews with smokers) and clinical and scientific experts (assessed using 2 Delphi studies with 24 scientists and 38 clinicians) were assessed regarding cessation tool decision making and preferred DA content. These findings, together with principles from the Self-Determination Theory, served as input for the development of the online DA. A first DA prototype was alpha-tested in September 2019 and beta-tested for usability in December 2019; feedback was incorporated and resulted in a final version. The final DA contains (1) an information section, (2) an optional knowledge quiz, (3) a brief smoking assessment, (4) intuitive decision, (5) intermediate advice, (6) an explicit VCM, (7) tailored advice, and (8) access information. A randomized controlled trial is currently being conducted to assess the DA’s (cost-)effectiveness compared to a DA that does not include the explicit VCM and the tailored advice; specifically, the DA’s effect on smoking abstinence, uptake of evidence-based cessation assistance, smoking abstinence mediated through uptake of evidence-based cessation assistance, and decisional conflict are investigated. Participants are randomly allocated to receive access to 1 of the 2 DAs and are asked to complete 5 questionnaires (including the baseline questionnaire) over a period of 12 months. To evaluate the effects of the DA on the outcome measures, logistic and linear regression analyses as well as mediation analyses will be carried out. An economic evaluation will be performed to assess the cost-effectiveness.ResultsData regarding the effect of the VISOR DA are currently being collected, and data collection is expected to be concluded in 2021.ConclusionsBy making use of an iterative process that integrated different stakeholders’ perspectives (including end users), we were able to systematically design an evidence-based DA. The study will contribute to the current knowledge regarding smoking cessation DA application, the added value of explicit VCMs, and the effect of behavioral and informed decision-making outcomes.Trial RegistrationNetherlands Trial Register NL8270; https://www.trialregister.nl/trial/8270International Registered Report Identifier (IRRID)DERR1-10.2196/21772

Abstract PO-017: Using a Delphi panel to establish content for a breast cancer screening decision aid inclusive of women with limited health literacy

Abstract Breast cancer screening decision aids that help women understand their risk for cancer and available screening options can improve the quality of decision-making for women in their 40s, but existing decision aids do not address the needs of women with limited health literacy. We conducted a Delphi panel among breast cancer screening and decision science experts to determine content for a breast cancer screening decision aid for women ages 40-54 who have limited health literacy. Experts were those with an advanced degree (MD, PhD), at least 3 years of experience, and content expertise in breast cancer screening, health literacy, or decision aid design. Experts were invited via email to participate in an online Delphi panel, which aimed to establish consensus on decision aid content, guided by the International Patient Decision Aid Standards. Experts rated the importance of each item on a scale from 1 (not important) to 9 (very important), as well as how strong they felt the evidence was to support each. Open-ended responses explaining ratings were gathered, and in Round 1 experts were asked to nominate new items for inclusion. Following RAND methods, the 30th - 70th percentile range, central point, and asymmetry index were calculated for each item. From these values, a disagreement index was determined, and if the value was >1, indicating disagreement, the item was moved to the next round. Otherwise, consensus was established, and the item was omitted from future rounds. Between rounds, experts received a summary of their rating for each item relative to others, along with a summary of the open-ended explanations. The process was repeated for Rounds 2 and 3. 15 experts were invited, 9 agreed and 8 completed Round 1. All eight participants were female, with an average age of 53. Seven were white and 2 Asian. Five held medical doctorate degrees, 3 had PhDs. Seven experts completed all 3 rounds. Round 1 included 55 items, 30 of which obtained consensus (disagreement index < 1). 29 items were reviewed in Round 2 (25 from Round 1, plus 4 newly nominated items), 15 of which obtained consensus, leaving a final round of 14 items. In Round 3, 1 item achieved consensus, 4 items converged around uncertainty, and 9 did not reach consensus. Experts disagreed or were uncertain on the importance of including breast cancer risk factors and whether a description of the multiple screening modalities available should be included. Explanations for these items described balancing an ethical imperative to provide information and avoid paternalism while limiting information extraneous to the decision. While guidelines suggest that the age of initiating mammography and modalities used should involve an assessment of risk of developing breast cancer, experts did not agree about the inclusion of risk factor or modality information in a breast cancer screening decision aid for women with limited health literacy. Balancing detail with simplicity remains a challenge in determining content for decision support tools that seek to include a range of literacy levels. Citation Format: Christine M. Gunn, Tracy A. Battaglia, Michael K. Paasche-Orlow, Mara Schonberg, Ariel Maschke, Nancy R. Kressin. Using a Delphi panel to establish content for a breast cancer screening decision aid inclusive of women with limited health literacy [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-017.

Measures of Decision Aid Quality Are Preference-Sensitive and Interest-Conflicted - 2: Empirical Measures.

Empirical measures of 'decision aid quality', like normative ones, are of a formative construct and therefore embody interest-conflicted preferences in their criteria selection and weighting. The preferences of the International Patient Decision Aid Standards consortium distinguish the quality of the decision-making process and the quality of the choice that is made '(i.e., decision quality)'. The Decision Conflict Scale features heavily in their profile measure of the former and Decision Quality Instruments (DQIs), have been developed by members of the consortium to measure the latter. We confirm that both of these, and other components, like the higher-level measures, are preference-sensitive and interest-conflicted. Non-financial interest-conflicted preferences are endemic in healthcare research, policy-making, and practice. That they are inevitable means the main problem lies in the denial of this and attitude to and behaviour towards alternatives, equally interest-conflicted.

Developing and evaluating a patient decision aid for hormone therapy to manage symptoms of surgical menopause: the story behind the "SheEmpowers" patient decision aid.

To develop and evaluate an evidence-based patient decision aid (PDA) that can support women making decisions on hormone therapy (HT) for the management of early surgical menopause. The PDA development was guided by the Ottawa Decision Support Framework and the International Patient Decision Aid Standards and involved three phases: an exploratory phase to identify women's decisional needs; a development phase to identify evidence related to treatment options and draft initial prototype; and an evaluation phase to evaluate the prototype and elicit views on acceptability in women (N = 12). All phases were driven by a multidisciplinary group of researchers, clinicians, and patient stakeholders to ensure women's priorities were met. A prototype PDA was drafted based on needs identified from the exploratory phase. The PDA has five domains: information on surgical menopause and HT; HT outcome probabilities; patient stories; values clarification; and guidance in deliberation. Participants in the evaluation phase perceived the tool as acceptable and offered suggestions for modifications. Through our adopted, systematic approach the SheEmpowers PDA was developed to help women overcome deterrents to decision-making related to lack of knowledge, decision-making skills, and involvement in therapy decisions. The decisional effectiveness of the tool is to be assessed in future studies.

Measures of Decision Aid Quality Are Preference-Sensitive and Interest-Conflicted - 1: Normative Measures.

The belief that following rigorous inclusive methods will eliminate bias from 'quality' measures ignores the preferences necessarily embedded in any formative instrument. These preferences almost always reflect the interests of its developers when one uses the wide definition of 'interest' appropriate in healthcare research and provision. We focus on the International Patient Decision Aid Standards instrument, a popular normative measure of decision aid quality. Drawing on its application to a set of 23 breast cancer screening decision aids, we show the effects of modifications that reflect our own different interest-conflicted preferences. It is emphasised that the only objection is to the implication that any formative instrument should be promoted or treated as the 'the gold standard', without a conflict of interests disclaimer, and to the implication that other instruments cannot provide equally valid, high-quality measures.

A decision aid for additional findings in genomic sequencing: Development and pilot testing

ObjectiveTo describe the development of a web-based, patient-facing decision aid to support patients and research participants to make an informed, values-based decision about whether to receive additional results from genomic sequencing. MethodsWe developed the decision aid following the multi-step process described in the International Patient Decision Aids Standards. This utilized literature review, focus groups, and alpha testing with research participants undergoing clinical genomic sequencing. ResultsThe decision aid, the Optional Results Choice Aid (ORCA), includes a seven-question “values clarification exercise,” illustrative patient quotes, and summative guidance for the user. The decision aid was found to be highly readable, acceptable and relevant in alpha testing. ConclusionWe developed a decision aid to support informed, values-based decision making for patients and research participants considering whether to receive additional results from genomic sequencing. ORCA is being implemented in the NHGRI-funded Cancer Health Assessment Reaching Many (CHARM) study, where we are measuring informed values-choice congruence. Practice implicationsORCA was designed to support patients and research participants to make an informed, values-based decision about whether to receive additional results from genomic sequencing.

Computer-Tailored Decision Support Tool for Lung Cancer Screening: Community-Based Pilot Randomized Controlled Trial

BackgroundLung cancer screening is a US Preventive Services Task Force Grade B recommendation that has been shown to decrease lung cancer-related mortality by approximately 20%. However, making the decision to screen, or not, for lung cancer is a complex decision because there are potential risks (eg, false positive results, overdiagnosis). Shared decision making was incorporated into the lung cancer screening guideline and, for the first time, is a requirement for reimbursement of a cancer screening test from Medicare. Awareness of lung cancer screening remains low in both the general and screening-eligible populations. When a screening-eligible person visits their clinician never having heard about lung cancer screening, engaging in shared decision making to arrive at an informed decision can be a challenge. Methods to effectively prepare patients for these clinical encounters and support both patients and clinicians to engage in these important discussions are needed.ObjectiveThe aim of the study was to estimate the effects of a computer-tailored decision support tool that meets the certification criteria of the International Patient Decision Aid Standards that will prepare individuals and support shared decision making in lung cancer screening decisions.MethodsA pilot randomized controlled trial with a community-based sample of 60 screening-eligible participants who have never been screened for lung cancer was conducted. Approximately half of the participants (n=31) were randomized to view LungTalk—a web-based tailored computer program—while the other half (n=29) viewed generic information about lung cancer screening from the American Cancer Society. The outcomes that were compared included lung cancer and screening knowledge, lung cancer screening health beliefs (perceived risk, perceived benefits, perceived barriers, and self-efficacy), and perception of being prepared to engage in a discussion about lung cancer screening with their clinician.ResultsKnowledge scores increased significantly for both groups with greater improvement noted in the group receiving LungTalk (2.33 vs 1.14 mean change). Perceived self-efficacy and perceived benefits improved in the theoretically expected directions.ConclusionsLungTalk goes beyond other decision tools by addressing lung health broadly, in the context of performing a low-dose computed tomography of the chest that has the potential to uncover other conditions of concern beyond lung cancer, to more comprehensively educate the individual, and extends the work of nontailored decision aids in the field by introducing tailoring algorithms and message framing based upon smoking status in order to determine what components of the intervention drive behavior change when an individual is informed and makes the decision whether to be screened or not to be screened for lung cancer.International Registered Report Identifier (IRRID)RR2-10.2196/resprot.8694

High Users of Healthcare Services: Development and Alpha Testing of a Patient Decision Aid for Case Management.

Some patients with complex healthcare needs become high users of healthcare services. Case management allows these patients and their interprofessional team to work together to evaluate their needs, priorities and available resources. High-user patients must make an informed decision when choosing whether to engage in case management and currently there is no tool to support them. The objective of this study was to develop and conduct a pilot alpha testing of a patient decision aid that supports high-user patients with complex needs and the teams who guide those patients in shared decision making when engaging in case management. We chose a user-centered design to co-develop a patient decision aid with stakeholders informed by the Ottawa Research Institute and International Patient Decision Aid Standards frameworks. Perceptions and preferences for the patient decision aid's content and format were assessed with patients and clinicians and were iteratively collected through interviews and focus groups. We developed a prototype and assessed its acceptability by using a think-aloud method and a questionnaire with three patient-partners, six clinicians and seven high-user patients with complex needs. The three rounds of evaluation to assess the decision aid's acceptability highlighted comments related to simplicity, readability and visual aspect. A section presenting clinical vignettes including story telling was identified as the most helpful. We created and evaluated a patient decision aid. Considering the positive comments, we believe that this aid has the potential to help high-user patients with complex care needs make better choices concerning case management.

Can Upstream Patient Education Improve Fracture Care in a Digital World? Use of a Decision Aid for the Treatment of Displaced Diaphyseal Clavicle Fractures.

The increasing proportion of telemedicine and virtual care in orthopaedic surgery presents an opportunity for upstream delivery of patient facing tools, such as decision aids. Displaced diaphyseal clavicle fractures (DDCFs) are ideal for a targeted intervention because there is no superior treatment, and decisions are often dependent on patient's preference. A decision aid provided before consultation may educate a patient and minimize decisional conflict similarly to inperson consultation with an orthopaedic traumatologist. Patients with DDCF were enrolled into 2 groups. The usual care group participated in a discussion with a trauma fellowship-trained orthopaedic surgeon. Patients in the intervention group were administered a DDCF decision aid designed with the International Patient Decision Aid Standards. Primary comparisons were made based on a decisional conflict score. Secondary outcomes included treatment choice, pain score, QuickDASH, and opinion toward cosmetic appearance. A total of 41 patients were enrolled. Decisional conflict scores were similar and low between the 2 groups: 11.8 (usual care) and 11.4 (decision aid). There were no differences in secondary outcomes between usual care and the decision aid. Our decision aid for the management of DDCF produces a similarly low decisional conflict score to consultation with an orthopaedic trauma surgeon. This decision aid could be a useful resource for surgeons who infrequently treat this injury or whose practices are shifting toward telemedicine visits. Providing a decision aid before consultation may help incorporate patient's values and preferences into the decision-making process between surgery and nonoperative management. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Development and Acceptability of a Patient Decision Aid for Pain Management in Juvenile Idiopathic Arthritis: The JIA Option Map.

Youths with juvenile idiopathic arthritis (JIA) often experience pain, which reduces their quality of life. A diversity of pain management options exists for these patients, but few discussions happen in clinical settings. Our team is developing a web-based patient decision aid (PDA) to help youths with JIA, parents, and their health care providers (HCPs) make informed and preference-based decisions about pain management options. The objective of this study was to develop a paper-based prototype of the web-based PDA and to assess its acceptability. We developed a paper-based prototype of the PDA, called the JIA Option Map, using an iterative process following the International Patient Decision Aid Standards and based on the Ottawa Decision Support Framework. We held three consensus meetings and a follow-up online survey followed by discussions among team members to agree on the format and content of the PDA. We then evaluated acceptability through interviews with 12 youth with JIA (aged 8-18 years), 12 parents, and 11 HCPs. Participants from rheumatology clinics in Canada and the USA reviewed the PDA and assessed its usefulness, content, and format. Interviews were audiotaped, transcribed verbatim, and analyzed using simple descriptive content analysis. The PDA contains an assessment of pain and current treatments, a values-clarification exercise, a list of 33 treatment options with evidence-based information, and a goal-setting exercise. All participants agreed that it would be a useful tool for making decisions about pain management. Participants appreciated the incorporation of scientific evidence and visuals to demonstrate the benefits of treatment options but suggested describing the source of the evidence more thoroughly. Participants suggested adding complementary medicine and nutrition to the available treatment options and removing options that are primarily used to reduce inflammation. Most participants preferred an interactive web-based version of the PDA that would show a few options consistent with their preferences, followed by a discussion with HCPs. The PDA was deemed acceptable to all participants, with a few modifications. This feedback was used to improve the PDA by simplifying and clarifying the information and adjusting the number of treatment options presented. Work is underway to develop an interactive web-based version with an algorithm to present options tailored to each user.

Making shared decision-making (SDM) a reality: protocol of a large-scale long-term SDM implementation programme at a Northern German University Hospital

IntroductionShared decision-making (SDM) is not yet widely used when making decisions in German hospitals. Making SDM a reality is a complex task. It involves training healthcare professionals in SDM communication...

Improving treatment decision-making in bipolar II disorder: a phase II randomised controlled trial of an online patient decision-aid

BackgroundMany patients with bipolar II disorder (BPII) prefer to be more informed and involved in their treatment decision-making than they currently are. Limited knowledge and involvement in one’s treatment is also likely to compromise optimal BPII management. This Phase II RCT aimed to evaluate the acceptability, feasibility, and safety of a world-first patient decision-aid website (e-DA) to improve treatment decision-making regarding options for relapse prevention in BPII. The e-DA’s potential efficacy in terms of improving quality of the decision-making process and quality of the decision made was also explored.MethodsThe e-DA was based on International Patient Decision-Aid Standards and developed via an iterative co-design process. Adults with BPII diagnosis (n = 352) were recruited through a specialist outpatient clinical service and the social media of leading mental health organisations. Participants were randomised (1:1) to receive standard information with/without the e-DA (Intervention versus Control). At baseline (T0), post-treatment decision (T1) and at 3 months’ post-decision follow-up (T2), participants completed a series of validated and purpose-designed questionnaires. Self-report and analytics data assessed the acceptability (e.g., perceived ease-of-use, usefulness; completed by Intervention participants only), safety (i.e., self-reported bipolar and/or anxiety symptoms), and feasibility of using the e-DA (% accessed). For all participants, questionnaires assessed constructs related to quality of the decision-making process (e.g., decisional conflict) and quality of the decision made (e.g., knowledge of treatment options and outcomes).ResultsIntervention participants endorsed the e-DA as acceptable and feasible to use (82.1–94.6% item agreement); most self-reported using the e-DA either selectively (51.8%; relevant sections only) or thoroughly (34%). Exploratory analyses indicated the e-DA’s potential efficacy to improve decision-making quality; most between-group standardised mean differences (SMD) were small-to-moderate. The largest potential effects were detected for objective treatment knowledge (− 0.69, 95% CIs − 1.04, − 0.33 at T1; and − 0.57, 95% CIs − 0.99,-0.14 at T2), decisional regret at T2 (0.42, 95% CIs 0.01, 0.84), preparation for decision-making at T1 (− 0.44, 95% CIs − 0.81, − 0.07), and the Decisional Conflict Scale Uncertainty subscale (0.42, 95% CIs 0.08, 0.08) and Total (0.36, 95% CIs 0.30, 0.69) scores, with all SMDs favouring the Intervention over the Control conditions. Regarding safety, e-DA use was not associated with worse bipolar symptoms or anxiety.ConclusionThe e-DA appears to be acceptable, feasible, safe and potentially efficacious at improving patients’ decision-making about BPII treatment. Findings also support the future adoption of the e-DA into patient care for BPII to foster treatment decisions based on the best available evidence and patient preferences.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12617000840381 (prospectively registered 07/06/2017).

Development of a patient decision aid for treatment resistant depression

Background: Shared decision-making (SDM) involves patients and clinicians choosing treatment jointly. SDM in mental health is hampered by lack of well-developed supporting tools. We describe an evidence-based patient decision aid (PDA) to facilitate SDM for treatment-resistant depression (TRD) following US National Quality Forum standards which are based upon the International Patient Decision Aid Standards (IPDAS).Methods: A web-based PDA was developed by a multidisciplinary steering committee of clinicians, patient advocates, patients and a decision scientist. Development included creating content consistent with decision-making domains that are impacted by patient preference in TRD. Development was guided by literature review, group conference calls/discussions, patient and clinician interviews (N = 8), high and lower literacy focus groups (N = 11) and pilot study (N = 5). The PDA presents risk-benefit information on domains (e.g., effectiveness, mode of administration, side effects, cost) and includes values clarification exercises. Pilot study patients were administered the Decisional Conflict Scale (DCS) and Decision Self-Efficacy Scale (DSES) prior to and following PDA interaction and clinician SDM.Results: During the pilot, prior to PDA interaction, mean (standard deviation) DCS score was 42.2 (14.4) and DSES score was 86.0 (14.6) out of 100. Following PDA interaction and SDM, DCS decreased (improved) to 28.1 (SD 4.1) and DSES increased to 95.5 (6.7). All patients endorsed that the PDA helped them to: recognize pros and cons of options; understand how treatments were administered, possible side-effects, and likelihood of benefit; recognize what was important relative to the decision; organize thoughts and prepare for a discussion with their clinician.Conclusions: This PDA may support SDM in TRD. A future trial to determine impact of the present SMD on decision-making quality is warranted. It also highlights gaps in comparative effectiveness trials that could guide equitable shared decision-making.

Shared decision-making for the management of small renal masses: Development and acceptability testing of a novel patient decision aid.

Shared decision-making incorporates patients' values and preferences to achieve high-quality decisions. The objective of this study was to develop an acceptable patient decision aid to facilitate shared decision-making for the management of small renal masses (SRMs). The International Patient Decision Aids Standards were used to guide an evidence-based development process. Management options included active surveillance, thermal ablation, partial nephrectomy, and radical nephrectomy. A literature review was performed to provide incidence rates for outcomes of each option. Once a prototype was complete, alpha-testing was performed using a 10-question survey to assess acceptability with patients, patient advocates, urologists, and methodological experts. The primary outcome was acceptability of the decision aid. A novel patient decision aid was created to facilitate shared decision-making for the management of SRMs. Acceptability testing was performed with 20 patients, 10 urologists, two patient advocates, and one methodological expert. Responders indicated the decision aid was appropriate in length (82%, 27/33), well-balanced (82%, 27/33), and had language that was easy to follow (94%, 31/33). All patient responders felt the decision aid would have been helpful during their consultation and would recommend the decision aid for future patients (100%, 20/20). Most urologists reported they intend to use the decision aid (90%, 9/10). A novel patient decision aid was created to facilitate shared decision-making for management of SRMs. This clinical tool was acceptable with patients, patient advocates, and urologists and is freely available at: https://decisionaid.ohri.ca/decaids.html.

Quality and effectiveness of osteoporosis treatment decision aids: a systematic review and environmental scan.

Decision aids (DAs) are evidence-based tools that support shared decision-making (SDM) implementation in practice; this study aimed to identify existing osteoporosis DAs and assess their quality and efficacy; and to gain feedback from a patient advisory group on findings and implications for further research. We searched multiple bibliographic databases to identify research studies from 2000 to 2019 and undertook an environmental scan (search conducted February 2019, repeated in March 2020). A pair of reviewers, working independently selected studies for inclusion, extracted data, evaluated each trial's risk of bias, and conducted DA quality assessment using the International Patient Decision Aid Standards (IPDAS). Public contributors (patients and caregivers with experience of osteoporosis and fragility fractures) participated in discussion groups to review a sample of DAs, express preferences for a new DA, and discuss plans for development of a new DA. We identified 6 studies, with high or unclear risk of bias. Across included studies, use of an osteoporosis DA was reported to result in reduced decisional conflict compared with baseline, increased SDM, and increased accuracy of patients' perceived fracture risk compared with controls. Eleven DAs were identified, of which none met the full set of IPDAS criteria for certification for minimization of bias. Public contributors expressed preferences for encounter DAs that are individualized to patients' own needs and risk. Using a systematic review and environmental scan, we identified 11 decision aids to inform patient decisions about osteoporosis treatment and 6 studies evaluating their effectiveness. Use of decision aids increased accuracy of risk perception and shared decision-making but the decision aids themselves fail to comprehensively meet international quality standards and patient needs, underpinning the need for new DA development.

Development of a Patient Decision Aid for the Treatment of Osteoporosis Among Filipino Postmenopausal Women.

BackgroundGuidelines for osteoporosis have provided recommendations on when to offer pharmacologic management for postmenopausal women, but do not specify which “best” medication to start. The choice of therapy depends on the efficacy, safety/tolerability of the drug and the patient’s profile and preferences. Patient decision aids (PtDA) are tools designed to facilitate shared decision-making (SDM) between the patient and health care provider for conditions where there are several available options, and the “best” choice is unclear. We aimed to develop a culturally acceptable patient decision aid on the treatment of osteoporosis among Filipino postmenopausal women at risk of osteoporotic fractures.MethodologyA qualitative approach and an iterative process was employed in this study following the guidance of the International Patient Decision Aid Standards (IPDAS). Phase 1 (Needs Assessment) involved interviews with 8 physicians who are involved in the care of women with osteoporosis and focus group discussions with 19 postmenopausal women with osteoporosis who have received treatment. Phase 2 (PtDA Development) involved a systematic review of evidence and development of an initial prototype through several iterations with an expert panel. The final prototype was pilot tested in actual clinical encounters (Phase 3).ResultsThe final PtDA consists of 6 laminated flashcards, which illustrate the different considerations that are important to patients when selecting an anti-osteoporosis treatment (efficacy, method, frequency of administration, side effects and cost), and a fracture worksheet to illustrate individualized effects of the treatments on the patient's fracture risk. These are accompanied by a clinician guide on how to use the PtDA during consultations, which includes information on non-pharmacologic management of osteoporosis. The PtDA was acceptable to physicians and patients.ConclusionWith the integration of decisional needs assessment, clinical expertise, user preference and iterative revision testing, we were able to develop a culturally adapted PtDA on the treatment of osteoporosis among Filipino postmenopausal woman at risk of osteoporotic fractures for use during clinical encounters.

Development of a patient decision aid for the management of superficial basal cell carcinoma (BCC) in adults with a limited life expectancy

BackgroundBasal cell carcinoma (BCC) is a slow-growing, rarely lethal skin cancer that affects people 65 years or older. A range of treatment options exist for BCC, but there is little evidence available to guide patients and providers in selecting the best treatment options.ObjectivesThis study outlines the development of a patient decision aid (PDA) for low-risk BCC that can be used by patients and providers to assist in shared decision-making.MethodsIn accordance with the International Patient Decision Aids Standards (IPDAS) Collaboration framework, feedback from focus groups and semi-structured interviews with patients and providers, an initial prototype of the PDA was developed. This was tested using cognitive interviews and iteratively updated.ResultsWe created eighteen different iterations using feedback from 24 patients and 34 providers. The key issues identified included: 1) Addressing fear of cancer; 2) Communicating risk and uncertainty; 3) Values clarification; and 4) Time lag to benefit.LimitationsThe PDA does not include all possible treatment options and is currently paper based.ConclusionsOur PDA has been specifically adapted and designed to support patients with a limited life expectancy in making decisions about their low risk BCC together with their doctors.

Quality of decision aids developed for women at average risk of breast cancer eligible for mammographic screening: Systematic review and assessment according to the International Patient Decision Aid Standards instrument.

Mammographic screening contributes to a reduction in specific mortality, but it has disadvantages. Decision aids are tools designed to support people's decisions. Because these aids influence patient choice, their quality is crucial. The objective of the current study was to conduct a systematic review of decision aids developed for women eligible for mammographic screening who have an average breast cancer risk and to assess the quality of these aids. The systematic review included articles published between January 1, 1997, and August 1, 2019, in the PubMed, Embase, Cochrane, and PsycInfo databases. The studies were reviewed independently by 2 reviewers. Any study containing a decision aid for women eligible for mammographic screening with an average breast cancer risk was included. Two double-blind reviewers assessed the quality of the selected decision aids using the International Patient Decision Aid Standards instrument, version 3 (IPDASi). Twenty-three decision aids were extracted. Classification of decision aid quality using the IPDASi demonstrated large variations among the decision aids (maximum IPDASi score, 188; mean±SD score, 132.6±23.8; range, 85-172). Three decision aids had high overall scores. The 3 best-rated dimensions were disclosure (maximum score, 8; mean score, 6.8), focusing on transparency; information (maximum score, 32; mean score, 26.1), focusing on the provision of sufficient details; and probabilities (maximum score, 32; mean score 25), focusing on the presentation of probabilities. The 3 lowest-rated dimensions were decision support technology evaluation (maximum score, 8; mean score, 4.3), focusing on the effectiveness of the decision aid; development (maximum score, 24; mean score, 12.6), evaluating the development process; and plain language (maximum score, 4; mean score, 1.9), assessing appropriateness for patients with low literacy. The results of this review identified 3 high-quality decision aids for breast cancer screening.

A237 SHARED DECISION MAKING: DESIGN OF A PREGNANCY IN IBD DECISION AID (PIDA)

Abstract Background Given a significant proportion of women with inflammatory bowel disease (IBD) are of child-bearing age, the development of a pregnancy IBD decision aid would benefit patients and clinicians. Lack of IBD-specific reproductive knowledge has been associated with increased “voluntary childlessness” and may contribute to inappropriate medication changes during or after pregnancy. Decision aids support decision making in pregnancy in general, as well as in multiple other chronic diseases. However existing literature has not identified such a resource for women with IBD. Aims To develop a decision aid to improve decision making regarding preconception and pregnancy in IBD among women with IBD. Methods We followed the International Patient Decision Aids Standards (IPDAS). A steering committee of Canadian and Australian health care professionals with an interest in IBD management in pregnancy, in addition to patient representatives, was established. Themes chosen for discussion included inheritance, fertility, nutrition, medications, mode of delivery, breastfeeding, infant health. Initial patient and clinician focus groups were conducted and responses recorded with written/audio mediums. We developed an electronic PIDA draft that incorporates individualised information (type of IBD, pre-conception or pregnant, surgical history, medications) in personalized decision making. Further patient focus groups and interviews were conducted to obtain user opinion of the PIDA draft. Results In July 2017, patient and clinician focus groups were conducted at a Canadian site. Three patients (pre-conception) attended the focus group. Patient concerns - impact of disease and surgery on fertility and preterm delivery; impact of drug therapies on the fetus/ infant; impact of active disease on maternal and fetal/infant health. The clinician focus group included 3 IBD specialists, 2 IBD fellows, 2 IBD nurses, an obstetrician and a neonatal intensivist. Clinician concerns - absence of pre-conception counselling and lack of patient understanding about the impact of disease activity and IBD medication use in pregnancy. Additional patient feedback obtained through interviews (n=15) at two Canadian sites since March 2019 regarding the current electronic PIDA was positive, with comments about content, personalization, readability and unbiased presentation. Suggestions were made for inclusion of additional content such as impact of IBD on sexual function, laboratory changes during pregnancy, and timing of medications post-partum. Conclusions The pre and post PIDA design patient and clinician focus groups and interviews affirmed the role for PIDA. Main decisions considered necessary to address included ideal timing of conception pending disease activity, management of medications, and delivery methods. Ongoing user feedback will be obtained at Australian and Canadian sites during planned alpha testing. Funding Agencies WCHRI, Sinai Health System, UBC