scholarly journals Development and validation of a web-based patient decision aid for immunotherapy for patients with metastatic melanoma: study protocol for a multicenter randomized trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Pia Grabbe ◽  
Kathrin M. Gschwendtner ◽  
Imad Maatouk ◽  
Sophia B. Strobel ◽  
Martin Salzmann ◽  
...  
Keyword(s):  
Metastatic Melanoma ◽  
Decision Aid ◽  
Treatment Options ◽  
Medical Consultation ◽  
Secondary Outcome ◽  
Control Group ◽  
Patient Decision Aid ◽  
Risks And Benefits ◽  
Patient Decision ◽  
Decision Satisfaction

Abstract Background Patients with metastatic melanoma and their physicians are confronted with a complex decision regarding first-line therapy. Risks and benefits vary considerably between various treatment options. With this in mind, we aim to develop and evaluate a patient decision aid (PtDA) to inform patients about the risks and benefits of treatment options, namely, immunotherapy as monotherapy, immunotherapy as combination therapy, and treatment with BRAF/MEK inhibitors. We aim to test whether the use of this PtDA before medical consultation will increase patients’ knowledge of treatment options and thus promote shared decision-making (SDM) and patient decision satisfaction. Methods In total, 128 patients with metastatic melanoma from two German cancer centers will be randomized to the intervention group (IG), receiving access to the PtDA before medical consultation, or the control group (CG), receiving treatment as usual (TAU), i.e., medical consultation alone. There will be three major assessment points (before intervention, T0; after intervention, T1; and 3 months after intervention, T2). The main outcome is the patient’s knowledge of their treatment options, measured by a self-developed, piloted multiple-choice test at T1. Secondary outcome measures will include the extent of SDM during medical consultation, assessed by Observer OPTION 5, and patient decision satisfaction, assessed by the Satisfaction with Decision Scale (SwD), at T1 and T2. Discussion This trial will assess the effectiveness of a developed PtDA to enhance patient knowledge of treatment options for metastatic melanoma, SDM, and patient decision satisfaction. If the efficacy can be proven, the PtDA will be implemented nationwide in Germany to close a relevant gap in the education and care of patients with metastatic melanoma. Trial registration ClinicalTrials.gov NCT04240717. Registered on 27 January 2020

scholarly journals Patient decision aid based on multi-criteria decision analysis for disease-modifying drugs for multiple sclerosis: prototype development

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
I. E. H. Kremer ◽  
P. J. Jongen ◽  
S. M. A. A. Evers ◽  
E. L. J. Hoogervorst ◽  
W. I. M. Verhagen ◽  
...  
Keyword(s):  
Decision Making ◽  
Shared Decision Making ◽  
Decision Aid ◽  
Healthcare Professionals ◽  
Treatment Options ◽  
Shared Decision ◽  
Patient Decision Aid ◽  
Disease Modifying Drugs ◽  
Patient Decision ◽  
Further Development

Abstract Background Since decision making about treatment with disease-modifying drugs (DMDs) for multiple sclerosis (MS) is preference sensitive, shared decision making between patient and healthcare professional should take place. Patient decision aids could support this shared decision making process by providing information about the disease and the treatment options, to elicit the patient’s preference and to support patients and healthcare professionals in discussing these preferences and matching them with a treatment. Therefore, a prototype of a patient decision aid for MS patients in the Netherlands—based on the principles of multi-criteria decision analysis (MCDA) —was developed, following the recommendations of the International Patient Decision Aid Standards. MCDA was chosen as it might reduce cognitive burden of considering treatment options and matching patient preferences with the treatment options. Results After determining the scope to include DMDs labelled for relapsing-remitting MS and clinically isolated syndrome, users’ informational needs were assessed using focus groups (N = 19 patients) and best-worst scaling surveys with patients (N = 185), neurologists and nurses (N = 60) to determine which information about DMDs should be included in the patient decision aid. Next, an online format and computer-based delivery of the patient decision aid was chosen to enable embedding of MCDA. A literature review was conducting to collect evidence on the effectiveness and burden of use of the DMDs. A prototype was developed next, and alpha testing to evaluate its comprehensibility and usability with in total thirteen patients and four healthcare professionals identified several issues regarding content and framing, methods for weighting importance of criteria in the MCDA structure, and the presentation of the conclusions of the patient decision aid ranking the treatment options according to the patient’s preferences. Adaptations were made accordingly, but verification of the rankings provided, validation of the patient decision aid, evaluation of the feasibility of implementation and assessing its value for supporting shared decision making should be addressed in further development of the patient decision aid. Conclusion This paper aimed to provide more transparency regarding the developmental process of an MCDA-based patient decision aid for treatment decisions for MS and the challenges faced during this process. Issues identified in the prototype were resolved as much as possible, though some issues remain. Further development is needed to overcome these issues before beta pilot testing with patients and healthcare professionals at the point of clinical decision-making can take place to ultimately enable making conclusions about the value of the MCDA-based patient decision aid for MS patients, healthcare professionals and the quality of care.

scholarly journals Development and Pilot-Testing of a Patient Decision Aid for Left Ventricular Assist Device Placement

2016 ◽  
Author(s):  
Kristin Kostick ◽  
Estevan D. Delgado ◽  
Lidija A. Wilhelms ◽  
Courtenay R. Bruce ◽  
Jerry D. Estep ◽  
...  
Keyword(s):  
Heart Failure ◽  
Decision Aid ◽  
Treatment Options ◽  
Left Ventricular ◽  
Assist Device ◽  
Heart Failure Treatment ◽  
Ventricular Assist ◽  
Risks And Benefits ◽  
Patient Decision ◽  
Left Ventricular Assist

Background Studies indicate suboptimal patient understanding of the capabilities, lifestyle implications, and risks of LVAD therapy. This paper describes the development methodology and pilot-testing of a decision aid for Left Ventricular Assist Device (LVAD) placement, combining traditional needs-assessment with a novel user- centered approach. Methods and Results We developed the decision aid in line with the Ottawa Decision Support Framework (ODSF) and the International Patient Decision Aids Standards (IPDAS) for ensuring quality, patient-centered content. Structured interviews were conducted with patients, caregivers, candidates for LVAD treatment, and expert clinicians (n=71) to generate content based on patient values and decisional needs, and providers’ perspectives on knowledge needs for informed consent. The aid was alpha tested through cognitive interviews (n=5) and acceptability tested with LVAD patients (n=10), candidates (n=10), and clinicians (n=13). Patients, caregivers and clinicians reported they would recommend the aid to patients considering treatment options for heart failure. Patients and caregivers agreed that the decision aid is a balanced tool presenting risks and benefits of LVAD treatment and generating discussion about aspects of heart failure treatment that matter most to patients. Conclusion We identified gaps in knowledge about heart failure treatment options, including diagnosis, decision-making, surgery, post-operative maintenance and lifestyle changes. Challenges included presenting risks and benefits for informed decision making without frightening patients and circumventing reflection, and balancing an emphasis on LVAD with other alternative treatment options like comfort- directed palliative and supportive care.

scholarly journals Cardiology providers’ recommendations for treatments and use of patient decision aids for multivessel coronary artery disease

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Elizabeth L. Nichols ◽  
Glyn Elwyn ◽  
Anthony DiScipio ◽  
Mandeep S. Sidhu ◽  
A. James O’Malley ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Decision Aid ◽  
Artery Bypass ◽  
Treatment Options ◽  
Patient Decision Aid ◽  
Multivessel Coronary Artery Disease ◽  
Patient Decision ◽  
Appropriate Treatment ◽  
Artery Disease

Abstract Background Rates of recommending percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) vary across clinicians. Whether clinicians agree on preferred treatment options for multivessel coronary artery disease patients has not been well studied. Methods and results We distributed a survey to 104 clinicians from the Northern New England Cardiovascular Study Group through email and at a regional meeting with 88 (84.6%) responses. The survey described three clinical vignettes of multivessel coronary artery disease patients. For each patient vignette participants selected appropriate treatment options and whether they would use a patient decision aid. The likelihood of choosing PCI only or PCI/CABG over CABG only was modeled using a multinomial regression. Across all vignettes, participants selected CABG only as an appropriate treatment option 24.2% of the time, PCI only 25.4% of the time, and both CABG or PCI as appropriate treatment options 50.4% of the time. Surgeons were less likely to choose PCI over CABG (RR 0.14, 95% CI 0.03, 0.59) or both treatments over CABG only (RR 0.10, 95% CI 0.03, 0.34) relative to cardiologists. Overall, 65% of participants responded they would use a patient decision aid with each vignette. Conclusions There is a lack of consensus on the appropriate treatment options across cardiologists and surgeons for patients with multivessel coronary artery disease. Treatment choice is influenced by both patient characteristics and clinician specialty.

scholarly journals 0512 Impact of a Patient Decision-Aid When Selecting Insomnia Treatments and Factors Associated with Decisional Conflict: Preliminary Findings from an Ongoing Pragmatic Clinical Trial

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A196-A196
Author(s):  
J M Cheung ◽  
X Ji ◽  
H Ivers ◽  
C M Morin
Keyword(s):  
Clinical Trial ◽  
Decision Aid ◽  
Treatment Initiation ◽  
Treatment Options ◽  
Decisional Conflict ◽  
Patient Decision Aid ◽  
Pragmatic Clinical Trial ◽  
Usual Treatment ◽  
Patient Decision ◽  
Baseline Covariates

Abstract Introduction Preferences play an important role in determining insomnia treatment outcomes, but the validity of patient choice is rarely assessed. Uninformed preferences can lead to decisional conflict, which can negatively impact on treatment initiation, adherence, and subsequent outcomes. The current study aims to evaluate the impact of integrating a patient decision-aid as part of a pragmatic clinical trial and to identify baseline covariates associated with clinically significant decisional conflict (CSDC). Methods Secondary analysis of an ongoing pragmatic clinical trial for a two-stage cognitive behavioral therapy for insomnia (CBT-I) intervention was undertaken. Participants were referred from primary care clinics in Quebec City, Canada. Upon enrolment, participants were guided by a decision-aid, outlining the risks and benefits of prospective treatment options, when selecting their preferred arm of treatment in Phase 1. Options included SHUTi, SHUTi combined with an existing medication or continuing usual treatment with medication alone. Participants also completed a battery of sleep and mental health measures at baseline. Prior to treatment initiation, the 4-item SURE (Sure of myself; Understand information; Risk-Benefit ratio; Encouragement) scale was administered to screen for CSDC. Relationships between CSDC and baseline covariates were explored using Pearson correlations. Results Of the 55 participants initially enrolled, 94.5% (n=52) of participants preferentially selected SHUTi, either as sole treatment (n=24) or in combination with an existing medication (n=28), over usual treatment with medication alone (n=3). Overall, CSDC was only reported by 5.5% (n=3) of the sample population, with no group differences observed, suggesting effective clarification of treatment options through the decision-aid. Interestingly, higher SURE scores (i.e. less decisional conflict) were negatively correlated with depressive symptoms (r= -0.295, n= 55, p= 0.029) and anxiety symptoms (r= -0.301, n= 55, p= 0.026). Correlations with age, insomnia symptoms, duration of insomnia and fatigue were not statistically significant. Conclusion The patient decision-aid appeared to resolve decisional conflict for 94.5% (n=52) of participants. Findings allude to the potential influence of emotional status on information processing pathways in an insomnia context, warranting further research. Support Research supported by a grant from the Canadian Institutes of Health Research (CIHR-IRSC:0441002152).

Development and Alpha-testing of a Stepped Decision Aid for Patients Considering Nonsurgical Options for Knee and Hip Osteoarthritis Management

2016 ◽  
Vol 43 (10) ◽  
pp. 1891-1896 ◽  
Author(s):  
Karine Toupin April ◽  
Tamara Rader ◽  
Gillian A. Hawker ◽  
Dawn Stacey ◽  
Annette M. O’Connor ◽  
...  
Keyword(s):  
Decision Aid ◽  
Treatment Options ◽  
Healthcare Providers ◽  
Hip Osteoarthritis ◽  
Decisional Conflict ◽  
Informed Decision ◽  
Patient Decision Aid ◽  
American College Of Rheumatology ◽  
Patient Decision ◽  
Future Evaluation

Objective.To develop an innovative stepped patient decision aid (StDA) comparing the benefits and harms of 13 nonsurgical treatment options for managing osteoarthritis (OA) and to evaluate its acceptability and effects on informed decision making.Methods.Guided by the Ottawa Decision Support Framework and the International Patient Decision Aid Standards, the process involved (1) developing a decision aid with evidence on 13 nonsurgical treatments from the 2012 American College of Rheumatology OA clinical practice guidelines; and (2) interviewing patients with OA and healthcare providers to test its acceptability and effects on knowledge and decisional conflict.Results.The StDA helped make the decision explicit, and presented evidence on 13 OA treatments clustered into 5 steps or levels according to their benefits and harms. Probabilities of benefits and harms were presented using pictograms of 100 faces formatted to allow comparisons across sets of options. It also included a values clarification exercise and knowledge test. Feedback was obtained from 49 patients and 7 healthcare providers. They found that the StDA presented evidence in a clear manner, and helped patients clarify their values and make an informed decision. Some participants found that there was too much information and others said that there was not enough on each treatment option.Conclusion.This innovative StDA allows patients to consider both the evidence and their values for multiple options. The findings are being used to revise and plan future evaluation. The StDA is an example of how research evidence in guidelines can be implemented in practice.

scholarly journals Systematic Development of Patient Decision Aids: An Update from the IPDAS Collaboration

2021 ◽  
pp. 0272989X2110141
Author(s):  
Holly O. Witteman ◽  
Kristin G. Maki ◽  
Gratianne Vaisson ◽  
Jeanette Finderup ◽  
Krystina B. Lewis ◽  
...  
Keyword(s):  
Decision Aid ◽  
Decision Aids ◽  
Rapid Development ◽  
User Involvement ◽  
User Centered Design ◽  
Patient Decision Aid ◽  
Patient Decision Aids ◽  
Patient Decision ◽  
Development Processes ◽  
Systematic Development

Background The 2013 update of the evidence informing the quality dimensions behind the International Patient Decision Aid Standards (IPDAS) offered a model process for developers of patient decision aids. Objective To summarize and update the evidence used to inform the systematic development of patient decision aids from the IPDAS Collaboration. Methods To provide further details about design and development methods, we summarized findings from a subgroup ( n = 283 patient decision aid projects) in a recent systematic review of user involvement by Vaisson et al. Using a new measure of user-centeredness (UCD-11), we then rated the degree of user-centeredness reported in 66 articles describing patient decision aid development and citing the 2013 IPDAS update on systematic development. We contacted the 66 articles’ authors to request their self-reports of UCD-11 items. Results The 283 development processes varied substantially from minimal iteration cycles to more complex processes, with multiple iterations, needs assessments, and extensive involvement of end users. We summarized minimal, medium, and maximal processes from the data. Authors of 54 of 66 articles (82%) provided self-reported UCD-11 ratings. Self-reported scores were significantly higher than reviewer ratings (reviewers: mean [SD] = 6.45 [3.10]; authors: mean [SD] = 9.62 [1.16], P < 0.001). Conclusions Decision aid developers have embraced principles of user-centered design in the development of patient decision aids while also underreporting aspects of user involvement in publications about their tools. Templates may reduce the need for extensive development, and new approaches for rapid development of aids have been proposed when a more detailed approach is not feasible. We provide empirically derived benchmark processes and a reporting checklist to support developers in more fully describing their development processes. [Box: see text]

scholarly journals Basing Information on Comprehensive, Critically Appraised, and Up-to-Date Syntheses of the Scientific Evidence: An Update from the International Patient Decision Aid Standards

2021 ◽  
pp. 0272989X2199662
Author(s):  
Tammy C. Hoffmann ◽  
Mina Bakhit ◽  
Marie-Anne Durand ◽  
Lilisbeth Perestelo-Pérez ◽  
Catherine Saunders ◽  
...  
Keyword(s):  
Decision Aid ◽  
Scientific Evidence ◽  
Decision Aids ◽  
Future Research ◽  
Patient Decision Aid ◽  
Patient Decision Aids ◽  
Research Areas ◽  
Patient Decision ◽  
Evidence Quality ◽  
Emerging Issues

Background Patients and clinicians expect the information in patient decision aids to be based on the best available research evidence. The objectives of this International Patient Decision Aid Standards (IPDAS) review were to 1) check the currency of, and where needed, update evidence for the domain of “basing the information in decision aids on comprehensive, critically appraised, and up-to-date syntheses of the evidence”; 2) analyze the evidence characteristics of decision aids; and 3) propose updates to relevant IPDAS criteria. Methods We searched MEDLINE and PubMed to inform updates of this domain’s definitions, justifications, and components. We also searched 5 sources to identify all publicly available decision aids ( N = 471). Two assessors independently extracted each aid’s evidence characteristics. Results Minor updates to the definitions and theoretical justifications of this IPDAS domain are provided and changes to relevant IPDAS criteria proposed. Nearly all aids (97%) provided a year of creation/update, but most (81%) did not report an explicit update or expiration policy. No scientific references were cited in 33% of aids. Of the 314 that cited at least 1 reference, 39% cited at least 1 guideline, 44% cited at least 1 systematic review, and 23% cited at least 1 randomized trial. In 35%, it was unclear what statement in the aid the citations referred to. Only 14% reported any of the processes used to find and decide on evidence inclusion. Only 14% reported the evidence quality. Many emerging issues and future research areas were identified. Conclusions Although many emerging issues need to be addressed, this IPDAS domain is validated and criteria refined. High-quality patient decision aids should be based on comprehensive and up-to-date syntheses of critically appraised evidence.

scholarly journals Addressing Conflicts of Interest in Health and Medicine: Current Evidence and Implications for Patient Decision Aid Development

2021 ◽  
pp. 0272989X2110088
Author(s):  
Rachel Thompson ◽  
Zoe Paskins ◽  
Barry G. Main ◽  
Thaddeus Mason Pope ◽  
Evelyn C. Y. Chan ◽  
...  
Keyword(s):  
Conflict Of Interest ◽  
Decision Aid ◽  
Conflicts Of Interest ◽  
Guideline Development ◽  
Care Delivery ◽  
Quality Standards ◽  
Current Evidence ◽  
Unintended Effects ◽  
Patient Decision Aid ◽  
Patient Decision

Background More stringent policies for addressing conflicts of interest have been implemented around the world in recent years. Considering the value of revisiting conflict of interest quality standards set by the International Patient Decision Aid Standards (IPDAS) Collaboration, we sought to review evidence relevant to 2 questions: 1) What are the effects of different strategies for managing conflicts of interest? and 2) What are patients’ perspectives on conflicts of interest? Methods We conducted a narrative review of English-language articles and abstracts from 2010 to 2019 that reported relevant quantitative or qualitative research. Results Of 1743 articles and 118 abstracts identified, 41 articles and 2 abstracts were included. Most evidence on the effects of conflict of interest management strategies pertained only to subsequent compliance with the management strategy. This evidence highlighted substantial noncompliance with prevailing requirements. Evidence on patient perspectives on conflicts of interest offered several insights, including the existence of diverse views on the acceptability of conflicts of interest, the salience of conflict of interest type and monetary value to patients, and the possibility that conflict of interest disclosure could have unintended effects. We identified no published research on the effects of IPDAS Collaboration conflict of interest quality standards on patient decision making or outcomes. Limitations Because we did not conduct a systematic review, we may have missed some evidence relevant to our review questions. In addition, our team did not include patient partners. Conclusions The findings of this review have implications for the management of conflicts of interest not only in patient decision aid development but also in clinical practice guideline development, health and medical research reporting, and health care delivery.

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