Dataset Information

A systematic development process for patient decision aids.

ABSTRACT:

Background

The original version of the International Patient Decision Aid Standards (IPDAS) recommended that patient decision aids (PtDAs) should be carefully developed, user-tested and open to scrutiny, with a well-documented and systematically applied development process. We carried out a review to check the relevance and scope of this quality dimension and, if necessary, to update it.

Methods

Our review drew on three sources: a) published papers describing PtDAs evaluated in randomised controlled trials and included in the most recent Cochrane Collaboration review; b) linked papers cited in the trial reports that described how the PtDAs had been developed; and c) papers and web reports outlining the development process used by organisations experienced in developing multiple PtDAs. We then developed an extended model of the development process indicating the various steps on which documentation is required, as well as a checklist to assess the frequency with which each of the elements was publicly reported.

Results

Key features common to all patient decision aid (PtDA) development processes include: scoping and design; development of a prototype; 'alpha' testing with patients and clinicians in an iterative process; 'beta' testing in 'real life' conditions (field tests); and production of a final version for use and/or further evaluation. Only about half of the published reports on the development of PtDAs that we reviewed appear to have been field tested with patients, and even fewer had been reviewed or tested by clinicians not involved in the development process. Very few described a distribution strategy, and surprisingly few (17%) described a method for reviewing and synthesizing the clinical evidence. We describe a model development process that includes all the original elements of the original IPDAS criterion, expanded to include consideration of format and distribution plans as well as prototype development.

Conclusions

The case for including each of the elements outlined in our model development process is pragmatic rather than evidence-based. Optimal methods for ensuring that each stage of the process is carried out effectively require further development and testing.

SUBMITTER: Coulter A

PROVIDER: S-EPMC4044159 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A systematic development process for patient decision aids.

Coulter Angela A Stilwell Diana D Kryworuchko Jennifer J Mullen Patricia Dolan PD Ng Chirk Jenn CJ van der Weijden Trudy T

BMC medical informatics and decision making 20131129

<h4>Background</h4>The original version of the International Patient Decision Aid Standards (IPDAS) recommended that patient decision aids (PtDAs) should be carefully developed, user-tested and open to scrutiny, with a well-documented and systematically applied development process. We carried out a review to check the relevance and scope of this quality dimension and, if necessary, to update it.<h4>Methods</h4>Our review drew on three sources: a) published papers describing PtDAs evaluated in ra ...[more]

PMID: 24625093

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Project description:BackgroundProviding patient-centered care requires that patients partner in their personal health-care decisions to the full extent desired. Patient decision aids facilitate processes of shared decision-making between patients and their clinicians by presenting relevant scientific information in balanced, understandable ways, helping clarify patients' goals, and guiding decision-making processes. Although international standards stipulate that patients and clinicians should be involved in decision aid development, little is known about how such involvement currently occurs, let alone best practices. This systematic review consisting of three interlinked subreviews seeks to describe current practices of user involvement in the development of patient decision aids, compare these to practices of user-centered design, and identify promising strategies.Methods/designA research team that includes patient and clinician representatives, decision aid developers, and systematic review method experts will guide this review according to the Cochrane Handbook and PRISMA reporting guidelines. A medical librarian will hand search key references and use a peer-reviewed search strategy to search MEDLINE, EMBASE, PubMed, Web of Science, the Cochrane Library, the ACM library, IEEE Xplore, and Google Scholar. We will identify articles across all languages and years describing the development or evaluation of a patient decision aid, or the application of user-centered design or human-centered design to tools intended for patient use. Two independent reviewers will assess article eligibility and extract data into a matrix using a structured pilot-tested form based on a conceptual framework of user-centered design. We will synthesize evidence to describe how research teams have included users in their development process and compare these practices to user-centered design methods. If data permit, we will develop a measure of the user-centeredness of development processes and identify practices that are likely to be optimal.DiscussionThis systematic review will provide evidence of current practices to inform approaches for involving patients and other stakeholders in the development of patient decision aids. We anticipate that the results will help move towards the establishment of best practices for the development of patient-centered tools and, in turn, help improve the experiences of people who face difficult health decisions.Systematic review registrationPROSPERO CRD42014013241.

Project description:BackgroundA 2017 systematic review suggested patient engagement in clinical trials has been limited, with little active engagement in trial design or data analysis, interpretation or dissemination. Additionally, there remains limited sex/gender reporting in clinical trial research.ObjectivesThe overall goal of this project was to disseminate sex/gender knowledge and build capacity for patient engagement in clinical trials. Specific objectives were to (1) create capacity and identify opportunities for patient engagement in clinical trials and sponsor- or investigator-led activities (e.g. clinical trial design and conduct); and (2) enhance new/early investigator sex/gender knowledge and skills related to patient-oriented research (POR).MethodsWe used the Canadian Institutes of Health Research Strategy for Patient-Oriented Research (SPOR) Capacity Development Framework and the SPOR Patient Engagement Framework to guide three phases of this project: (1) conduct a scoping review using methods described by the Evidence for Policy and Practice Information (EPPI) and the Coordinating Centre at the Institute of Education (Phase 1); (2) host a 1-day POR consultation workshop (Phase 2); and (3) deliver a new/early investigator POR training day (Phase 3). Six electronic databases (CINAHL, MEDLINE, EMBASE, PsychInfo, the Cochrane Library, and AMED) were searched from 1996 using keywords and Medical Subject Heading (MeSH) terms in accordance with the International Association for Public Participation (IAP2) and the search criteria in the bibliographic databases. Standard approaches were used to search the grey literature.ResultsA total of 79 studies and over 150 websites were subject to data abstraction by team members, capturing information on sex/gender and SPOR's patient engagement guiding principles of inclusiveness, support, mutual respect, and co-building. Results were presented to 32 key stakeholders at the consultation workshop and input was sought on next steps using nominal group techniques. Based on the plethora of existing POR resources, relevant POR information from the scoping review was collated into two decision aids (patient and investigator) to determine readiness to engage with/as a patient partner in a clinical trial. The decision aids were presented at a POR training day with 88 new/early investigators, clinicians, patient partners and decision makers. The decision aids showed 'good' usability, assessed using the System Usability Scale (SUS). Attendees thought the decision aids were engaging, they increased their understanding of sex/gender, patient engagement and POR, and they would recommend them to others. POR principles and practices were integrated across all phases of the project. Patient partners (1) identified research priorities/search terms; (2) collected/analyzed data; (3) designed the patient partner decision aid; and (4) disseminated the results through presentation.ConclusionOur digital patient partner and investigator decision aids are the first to provide information technology to deliver sex/gender, POR knowledge, and decision support beyond the traditional decision aids used for health screening and/or treatment decisions. The decision aids have the potential to make a significant contribution to Canada's Strategy for POR and support the collaborative efforts of patients and investigators to build a sustainable, accessible and equitable health care system.

Project description:BackgroundEffective use of a patient decision aid (PtDA) can be affected by the user's health literacy and the PtDA's characteristics. Systematic reviews of the relevant literature can guide PtDA developers to attend to the health literacy needs of patients. The reviews reported here aimed to assess:MethodsWe reviewed literature for evidence relevant to these two aims. When high-quality systematic reviews existed, we summarized their evidence. When reviews were unavailable, we conducted our own systematic reviews.ResultsAim 1: In an existing systematic review of PtDA trials, lower health literacy was associated with lower patient health knowledge (14 of 16 eligible studies). Fourteen studies reported practical design strategies to improve knowledge for lower health literacy patients. In our own systematic review, no studies reported on values clarity per se, but in 2 lower health literacy was related to higher decisional uncertainty and regret. Lower health literacy was associated with less desire for involvement in 3 studies, less question-asking in 2, and less patient-centered communication in 4 studies; its effects on other measures of patient involvement were mixed. Only one study assessed the effects of a health literacy intervention on outcomes; it showed that using video to improve the salience of health states reduced decisional uncertainty. Aim 2: In our review of 97 trials, only 3 PtDAs overtly addressed the needs of lower health literacy users. In 90% of trials, user health literacy and readability of the PtDA were not reported. However, increases in knowledge and informed choice were reported in those studies in which health literacy needs were addressed.ConclusionLower health literacy affects key decision-making outcomes, but few existing PtDAs have addressed the needs of lower health literacy users. The specific effects of PtDAs designed to mitigate the influence of low health literacy are unknown. More attention to the needs of patients with lower health literacy is indicated, to ensure that PtDAs are appropriate for lower as well as higher health literacy patients.

Project description:ObjectivesTo update a previous systematic review to determine if patient decision aid (PDA) interventions generate savings in healthcare settings, and if so, from which perspective (ie, patient, organisation providing care, society).DesignSystematic review.Data sourcesMEDLINE, CINAHL, PsycINFO, Web of Science, Cochrane Library, Embase, Campbell Collaboration Library, EconLit, Business Source Complete, Centre for Reviews and Dissemination: NHS Economic Evaluations Database (NHS EED), Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA) from 15 March 2013 to 25 January 2019. The references of studies that met the eligibility criteria and any publications related to conference abstracts or registered clinical trials were reviewed to increase the sensitivity of the search.Eligibility criteriaFull and partial economic evaluations with an experimental, quasi-experimental or randomised controlled design were included. The intervention had to satisfy the pre-determined minimum conditions necessary to be defined as a PDA, and (for full evaluations) provide details on the comparator used.Data extraction and synthesisAll study outcomes and economic data were extracted. The reporting and quality of the economic analyses were independently assessed by two health economists.ResultsOf 5066 studies, 22 studies were included, including the 8 studies from the previous review. Twelve studies reported cost-savings (range=US$10 to US$81 156; US dollars in 2020), primarily from the organisational or health system perspective, and 10 studies did not. However, due to the quality of the economic analyses, and the related issues with the interpretative validity of results it would be inappropriate to say that PDAs will generate savings, from any perspective.ConclusionsIt is unclear whether PDAs will generate savings. Greater consensus on what constitutes a PDA and the need to compare them against usual care over a sufficient time horizon to allow valid assessment of costs and outcomes is required.Prospero registration numberCRD42019118457.

Dataset Information

A systematic development process for patient decision aids.

Background

Methods

Results

Conclusions

Publications

A systematic development process for patient decision aids.

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