Patient Decision Aid Standards Instrument Research Articles

Development and evaluation of a decision aid for women eligible for organized breast cancer screening according to international standards: A multi-method study

Backgroundand purpose:In France, women lack information to make a shared decision to start breast cancer screening. Decision aids are useful to facilitate this discussion, yet few meet international standards. The objective of this project was to build, validate and measure the quality of a decision aid for organized breast screening in France, in line with international standards, intended for both women and healthcare professionals. Materials and methodsThis mixed-methods study was conducted between January 2017 and June 2022. The prototype was developed from a qualitative study, systematic review and targeted literature review and alpha tested during two Delphi rounds. Readability was evaluated with the Flesch score and content with International Patient Decision Aid Standards Instrument (IPSASi). ResultsAn online decision aid, accessible at www.Discutons-mammo.fr, written in French was developed. The content included eligibility, information about breast screening the advantages and disadvantages of screening, patient preferences and a patient-based discussion guide using text, infographics, and videos. The Flesch readability test score was 65.4 and the IPDASi construct quality score was 176 out of 188. ConclusionsThis decision aid complies with IPDASi standards and could help women eligible for breast screening in France make a shared decision with a specialized healthcare professional about whether or not to participate in organized breast screening.

A systematic review of decision aids for gender affirming therapy.

BackgroundTransgender and gender diverse (TGD) persons considering gender affirming therapy have to make many complex medical decisions, potentially without understanding the associated harms or benefits of hormonal and surgical interventions. Further, clinicians are often unaware of how best to communicate information to persons seeking gender affirming therapy. Patient decision aids have been developed to provide evidence-based information as a way to help people make decisions in collaboration with their clinicians. It is unclear whether such tools exist for persons seeking gender affirming therapy. The objective of our systematic review is to search for and determine the quality of any existing patient decision aids developed for TGD persons considering gender affirming therapy, and the outcomes associated with their use.MethodsWe adapted a search strategy for databases using two key concepts “decision support intervention/patient decision aid” and “transgender”. We also conducted a brief online search of Google and abstracts from relevant conferences to identify any tools not published in the academic literature. Following study selection and data extraction, we used the International Patient Decision Aid Standards instrument (IPDASi) to assess the quality of patient decision aids, and the Standards for UNiversal reporting of patient Decision Aid Evaluations (SUNDAE) checklist to assess the quality of evaluations.ResultsWe identified 762 studies; none were identified from Google or conference content. One tool met our inclusion criteria: an online, pre-encounter patient decision aid for transmasculine genital gender-affirming surgery developed in Amsterdam, translated in English and Dutch. The tool met all the IPDASi qualifying criteria, and scored a 17/28 on the certification criteria, and 57/112 on the quality criteria. The efficacy of the patient decision aid has not been evaluated.ConclusionsDespite multiple decisions required for gender affirming therapies, only one patient decision aid has been developed for transmasculine genital reconstruction. Further research is required to develop patient decision aids for the multiple decision points along the gender affirming journey.

Online Decision Aids for Knee Arthroplasty: An Environmental Scan.

Knee arthroplasty is a high-risk, resource-intensive procedure that should be reserved for patients in whom the benefit will outweigh the risks. The provision of high-quality, publicly available decision aids can help patients to balance the benefits against the harms of treatments and to assist informed decision-making. The aim of this study was to identify and evaluate the content and readability of freely available knee arthroplasty decision aids. A systematic search using an environmental scan methodology of publicly available online materials was performed in December 2018. Included materials were assessed for quality using the International Patient Decision Aid Standards instrument (IPDASi), understandability and actionability from a patient's perspective using the Patient Education Materials Assessment Tool (PEMAT), and readability grade level using the Flesch-Kincaid Grade Level and the Gunning Fog Index. Of 761 online materials screened, 26 decision aids were identified. Only 18 (69%) may be considered to meet criteria to be defined as a decision aid and 4 (15%) met criteria suggesting that the material did not introduce potential harmful bias according to the IPDASi. The mean score (and standard deviation) for all decision aids was 74% ± 12% for understandability and 44% ± 19% for actionability using the PEMAT. Readability indices indicated a mean minimum reading level of Grade 10 (10.8 ± 2.5). No decision aid included a wait-and-see option. Few high-quality decision aids exist for patients considering knee arthroplasty and none include a wait-and-see option. Many do not provide actionable options and are pitched at above-average reading levels. Developers need to address these issues to encourage high-quality decision-making, especially for those with low health literacy.

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.

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.

Values and preferences of men for undergoing prostate-specific antigen screening for prostate cancer: a systematic review

ObjectivesTo investigate men’s values and preferences regarding prostate-specific antigen (PSA)-based screening for prostate cancer.DesignSystematic review.Data sourcesWe searched MEDLINE, EMBASE, PsycINFO and grey literature up to 2 September 2017.Eligibility criteriaPrimary studies...

Development and Usability Testing of a Computer-Tailored Decision Support Tool for Lung Cancer Screening: Study Protocol.

BackgroundAwareness of lung cancer screening remains low in the screening-eligible population, and when patients visit their clinician never having heard of lung cancer screening, engaging in shared decision making to arrive at an informed decision can be a challenge. Therefore, methods to effectively support both patients and clinicians to engage in these important discussions are essential. To facilitate shared decision making about lung cancer screening, effective methods to prepare patients to have these important discussions with their clinician are needed.ObjectiveOur objective is to develop a computer-tailored decision support tool that meets the certification criteria of the International Patient Decision Aid Standards instrument version 4.0 that will support shared decision making in lung cancer screening decisions.MethodsUsing a 3-phase process, we will develop and test a prototype of a computer-tailored decision support tool in a sample of lung cancer screening-eligible individuals. In phase I, we assembled a community advisory board comprising 10 screening-eligible individuals to develop the prototype. In phase II, we recruited a sample of 13 screening-eligible individuals to test the prototype for usability, acceptability, and satisfaction. In phase III, we are conducting a pilot randomized controlled trial (RCT) with 60 screening-eligible participants who have never been screened for lung cancer. Outcomes tested include lung cancer and screening knowledge, lung cancer screening health beliefs (perceived risk, perceived benefits, perceived barriers, and self-efficacy), perception of being prepared to engage in a patient-clinician discussion about lung cancer screening, occurrence of a patient-clinician discussion about lung cancer screening, and stage of adoption for lung cancer screening.ResultsPhases I and II are complete. Phase III is underway. As of July 15, 2017, 60 participants have been enrolled into the study, and have completed the baseline survey, intervention, and first follow-up survey. We expect to have results by December 31, 2017 and to have data analysis completed by March 1, 2018.ConclusionsResults from usability testing indicate that the computer-tailored decision support tool is easy to use, is helpful, and provides a satisfactory experience for the user. At the conclusion of phase III (pilot RCT), we will have preliminary effect sizes to inform a future fully powered RCT on changes in (1) knowledge about lung cancer and screening, (2) perceived risk of lung cancer, (3) perceived benefits of lung cancer screening, (4) perceived barriers to lung cancer screening, (5) self-efficacy for lung cancer screening, and (6) perceptions of being adequately prepared to engage in a discussion with their clinician about lung cancer screening.

Field testing of decision coaching with a decision aid for parents facing extreme prematurity

The objective of this study is to assess and modify an existing decision aid and field-test decision coaching with the modified aid during consultations with parents facing potential delivery at 23 to 24 weeks gestation. International Patient Decision Aid Standards instrument (IPDASi) scoring deficits, multi-stakeholder group feedback and α-testing guided modifications. Feasibility/acceptability were assessed. The Decisional Conflict Scale was used to measure participants' decisional conflict before (T1) and immediately after (T2) the consultation. IPDASi assessment of the existing aid (score 11/35) indicated it required updated data, more information and a palliative care description. Following modification, IPDASi score increased to 26/35. Twenty subjects (12 pregnancies) participated in field-testing; 15 completed all questionnaires. Most participants (89%) would definitely recommend this form of consultation. Decisional conflict scores decreased (P<0.001) between T1 (52±25) and T2 (10±16). Field testing demonstrated that consultations using the aid with decision coaching were feasible, reduced decisional conflict and may facilitate shared decision-making.

Quality of reporting of patient decision aids in recent randomized controlled trials: A descriptive synthesis and comparative analysis

ObjectiveVariable reporting of patient decision aids (PDAs) in published articles raises uncertainty about whether the intervention meets the definition of a PDA. We appraised the quality of reporting of PDA characteristics in randomized controlled trials (RCTs). MethodsRCTs eligible for the Cochrane review of PDAs and published June 2012 to April 2015 were included. Quality of PDA reporting was appraised using the International Patient Decision Aid Standards Instrument (v4.0). We descriptively synthesized and comparatively analysed qualifying and certification criteria reported in each publication against their presence in actual PDAs. ResultsSeventeen RCTs evaluating sixteen PDAs were included. Ten PDAs (58.8%) were reported using all qualifying criteria. Two (11.8%) were reported using all certification criteria. The median score for reporting qualifying criteria was 6 of 6 (range 4–6). The median score for reporting certification criteria was 2 of 10 (range 2–3) for screening and 1 of 6 (range 0–6) for treatment decisions. ConclusionReporting of PDAs in RCTs is suboptimal. Incomplete reporting poses challenges for clinicians and researchers needing to identify PDA content for clinical practice and/or future research. Practice implicationsAuthors should report IPDASi (v4.0) criteria in published articles. Reporting guidelines for PDA evaluation studies are in development to improve reporting within the scientific literature.

Quality assessment of patient leaflets on misoprostol-induced labour: does written information adhere to international standards for patient involvement and informed consent?

ObjectivesThe need for thorough patient information is increasing as maternity care becomes more medicalised. The aim was to assess the quality of written patient information on labour induction. In most...

Development and validation of a personalized, web-based decision aid for lung cancer screening using mixed methods: a study protocol.

BackgroundThe National Lung Screening Trial demonstrated that low-dose computed tomography (LDCT) screening could be an effective way to reduce lung cancer mortality. Informed decision-making in the context of lung cancer screening requires that potential screening subjects accurately recognize their own lung cancer risk, as well as the harms and benefits associated with screening, while taking into account their personal values and preferences.ObjectiveOur objective is to develop a Web-based decision aid in accordance with the qualifying and certification criteria in the International Patient Decision Aid Standards instrument version 4.0 that will assist patients in making informed decisions with regard to lung cancer screening.MethodsIn “alpha” testing, a prototype of the decision aid was tested for usability with 10 potential screening participants in focus groups. Feedback was also sought from public health and health risk communication experts external to the study. Following that, improvements to the prototype were made accordingly, and “beta” testing was done in the form of a quasi-experimental design—a before-after study—with a group of 60 participants. Outcomes tested were knowledge, risk perception of lung cancer and lung cancer screening, decisional conflict, and acceptability of the decision aid as determined by means of a self-administered electronic survey. Focus groups of a subsample of survey participants will be conducted to gain further insight into usability issues.ResultsAlpha testing is completed. Beta testing is currently being carried out. As of 2014 December 7, 60 participants had completed the before-after study. We expect to have results by 2015 January 31. Qualitative data collection and analysis are expected to be completed by 2015 May 31.ConclusionsWe hypothesize that this Web-based, interactive decision aid containing personalized, graphical, and contextual information on the benefits and harms of LDCT screening will increase knowledge, reduce decisional conflict, and improve concordance between patient preferences and the current US Preventive Services Task Force’s screening guidelines.

Factors explaining the heterogeneity of effects of patient decision aids on knowledge of outcome probabilities: a systematic review sub-analysis

BackgroundThere is considerable unexplained heterogeneity in previous meta-analyses of randomized controlled trials (RCTs) evaluating the effects of patient decision aids on the accuracy of knowledge of outcome probabilities. The purpose of this review was to explore possible effect modification by three covariates: the type of control intervention, decision aid quality and patients' baseline knowledge of probabilities.MethodsA sub-analysis of studies previously identified in the 2011 Cochrane review on decision aids for people facing treatment and screening decisions was conducted. Additional unpublished data were requested from relevant study authors to maximize the number of eligible studies. RCTs (to 2009) comparing decision aids with standardized probability information to control interventions (lacking such information) and assessing the accuracy of patient knowledge of outcome probabilities were included. The proportions of patients with accurate knowledge of outcome probabilities in each group were converted into relative effect measures. Intervention quality was assessed using the International Patient Decision Aid Standards instrument (IPDASi) probabilities domain.ResultsA main effects analysis of 17 eligible studies confirmed that decision aids significantly improve the accuracy of patient knowledge of outcome probabilities (relative risk = 1.80 [1.51, 2.16]), with considerable heterogeneity (87%). The type of control did not modify effects. Meta-regression suggested that the IPDASi probabilities domain score (reflecting decision aid quality) is a potential effect modifier (P = 0.037), accounting for a quarter of the variability (R2 = 0.28). Meta-regression indicated the control event rate (reflecting baseline knowledge) is a significant effect modifier (P = 0.001), with over half the variability in ln(OR) explained by the linear relationship with log-odds for the control group (R2 = 0.52); this relationship was slightly strengthened after correcting for the statistical dependence of the effect measure on the control event rate.ConclusionsPatients’ baseline level of knowledge of outcome probabilities is an important variable that explains the heterogeneity of effects of decision aids on improving accuracy of this knowledge. Greater relative effects are observed when the baseline proportion of patients with accurate knowledge is lower. This may indicate that decision aids are more effective in populations with lower knowledge.

Engaging Patients in Health Care Decisions in the Emergency Department Through Shared Decision‐making: A Systematic Review

Many decisions in the emergency department (ED) may benefit from patient involvement, even though this setting has been considered least conducive to shared decision-making (SDM). The objective was to conduct a systematic review to evaluate the approaches, methods, and tools used to engage patients or their surrogates in SDM in the ED. Five electronic databases were searched in conjunction with contacting content experts, reviewing selected bibliographies, and conducting citation searches using the Web of Knowledge database. Two reviewers independently selected eligible studies that addressed patient involvement and engagement in decision-making in the ED setting via the use of decision support interventions (DSIs), defined as decision aids or decision support designed to communicate probabilistic information on the risks and benefits of treatment options to patients as part of an SDM process. Eligible studies described and assessed at least one of the following outcomes: patient knowledge, experiences and perspectives on participating in treatment or management decisions, clinician or patient satisfaction, preference for involvement and/or degree of engagement in decision-making and treatment preferences, and clinical outcomes (e.g., rates of hospital admission/readmission, rates of medical or surgical interventions). Two reviewers extracted data on study characteristics, methodologic quality, and outcomes. The authors also assessed the extent to which SDM interventions adhered to good practice for the presentation of information on outcome probabilities (eight probability items from the International Patient Decision Aid Standards Instrument [IPDASi]) and had comprehensive development processes. Five studies met inclusion criteria and were synthesized using a narrative approach. Each study was of satisfactory methodologic quality and used a DSI to engage patients or their surrogates in decision-making in the ED across four domains: 1) management options for children with small lacerations; 2) options for rehydrating children presenting with vomiting or diarrhea or both; 3) risk of bacteremia (and associated complications), tests, and treatment options for febrile children; and 4) short-term risk of acute coronary syndrome (ACS) in adults with low-risk nontraumatic chest pain. Three studies had poor IPDASi probabilities and development process scores and lacked development informed by theory or involvement of clinicians and patients in development and usability testing. Overall, DSIs were associated with improvements in patients' knowledge and satisfaction with the explanation of their care, preferences for involvement, and engagement in decision-making and demonstrated utility for eliciting patients' preferences and values about management and treatment options. Two computerized DSIs (designed to predict risk of ACS in adults presenting to the ED with chest pain) were shown to reduce health care use without evidence of harm. None of the studies reported lack of feasibility of SDM in the ED. Early investigation of SDM in the ED suggests that patients may benefit from involvement in decision-making and offers no empirical evidence to suggest that SDM is not feasible. Future work is needed to develop and test additional SDM interventions in the ED and to identify contextual barriers and facilitators to implementation in practice.